1865 Emergency medical services system

DEPARTMENT OF HEALTH

[ 28 PA. CODE CHS. 1001, 1003, 1005, 1007, 1009, 1011, 1013, 1015, 1021, 1023, 1025, 1027, 1029, 1031 AND 1033 ]

Emergency Medical Services System

[41 Pa.B. 5865]
[Saturday, October 29, 2011]

 The Department of Health (Department) proposes to rescind Chapters 1001, 1003, 1005, 1007, 1009, 1011, 1013 and 1015 and adopt Chapters 1021, 1023, 1025, 1027, 1029, 1031 and 1033 to read as set forth in Annex A.

Purpose and Background

 The purpose of this proposed rulemaking is to facilitate implementation 35 Pa.C.S. §§ 8101—8157 (relating to Emergency Medical Services System Act) (EMS System Act). The EMS System Act repealed the Emergency Medical Services Act (prior EMS act) (35 P. S. §§ 6921—6938). The prior EMS act was the initial statute providing for the licensing and regulation of ambulance services in this Commonwealth. With the enactment of the EMS System Act, the Commonwealth has taken a significant step in moving forward with a comprehensive Statewide emergency medical services (EMS) system that is more responsive to the needs of the people of this Commonwealth. The EMS System Act is designed to achieve a higher quality, more flexible and better coordinated EMS system than that which was fostered under the prior EMS act.

 Efforts to replace the prior EMS act began over 10 years ago when the Pennsylvania Emergency Health Services Council (PEHSC) proposed consideration of a new EMS statute and formed several work groups to evaluate the different facets of the EMS system. These work groups recommended to the PEHSC and the PEHSC Board (Advisory Board) ultimately recommended to the Department several areas where statutory amendments were needed. The Advisory Board is designated by the EMS System Act to advise the Department on EMS matters. As the Department and the EMS community worked on amendments, it became clear that the scope of the necessary amendments dictated the need for a new statute. Senate Resolution 60 of 2005 also recognized weaknesses in the prior EMS act and recommended that this initiative be pursued. The development of new EMS legislation ensued and was spearheaded by the Department. Throughout that process, the Department engaged both private and government stakeholders and held more than 55 town meetings across this Commonwealth to discuss the draft legislation at various stages of its development. Throughout development of the legislation, the Department posted versions of the draft legislation on its web site and solicited comments.

 During its development, major private sector organizations such as the Pennsylvania Medical Society, the Pennsylvania Chapter of the American College of Emergency Physicians, PEHSC, the Pennsylvania Trauma Systems Foundation and the Ambulance Association of Pennsylvania expressed support for this legislation. Throughout the process, the Department also consulted with sister agencies such as the Department of Public Welfare, the Department of State, the Department of Aging, the Department of Transportation, the State Police, the Pennsylvania Emergency Management Agency (PEMA) and the Pennsylvania Public Utility Commission on matters of mutual concern to the Department and those agencies that could be addressed in the new EMS legislation. Issues presented by those matters were resolved among the agencies.

 A key feature of the EMS System Act is that it includes several provisions that will enable the EMS system, without the need for further statutory amendments, to quickly adapt and evolve to meet the changing needs of the people of this Commonwealth for emergency and urgent prehospital and interfacility medical care. Some of the key elements of the EMS System Act not included in the prior EMS act are as follows:

 • The scope of practice of EMS personnel closely tracks the EMS Scope of Practice Model that the National Association of State EMS Officials has developed for the National Highway Traffic Safety Administration.

 • The Department is empowered to establish through regulations new types of EMS providers to meet specialized EMS needs as they are identified.

 • The Department is empowered to expand the scope of practice of EMS personnel as the EMS practice model changes.

 • Licenses and certifications will be permanent, subject to removal for disciplinary reasons, but continued practice will be conditioned upon a biennial or triennial registration of the license or certification and continued practice of EMS providers will also be predicated on them meeting continuing education requirements or passing written and practical skills tests.

 • Ambulance services, which had to meet specified staffing and vehicle requirements under the prior EMS act, will be replaced by EMS agencies, which may have a myriad of configurations and provide different types of EMS (such as ambulance service, quick response service (QRS), wilderness EMS service and tactical EMS service). EMS agencies will be required to meet standards pertinent to the services they are licensed to offer.

 • EMS agencies will be required to have a medical director.

 • Ambulance drivers, who were not regulated under the prior EMS act, will need to become certified and regulated. Ambulance attendants, who were also not regulated under the prior EMS act, will be certified and regulated as emergency medical responders (EMR).

 • The Department is granted emergency suspension powers to deal with an EMS provider or EMS vehicle operator (EMSVO) who presents a clear and immediate danger to the public health and safety.

 • The Department's disciplinary options are expanded to include the issuance of civil money penalties and the Department is granted jurisdiction to fine unlicensed entities that function as EMS agencies and uncertified persons who practice as EMS providers.

 • The Department is empowered to enter into reciprocity agreements with others states for the certification of EMS providers.

 • The Department is given the authority to enter into agreements with other states which may include, as appropriate to effectuate the purposes of the EMS System Act, the acceptance of EMS resources in other states that do not fully satisfy the requirements in the EMS System Act.

 • The Department is empowered to issue conditional temporary licenses indefinitely if the Department determines it is in the public interest to do so.

 • Medical command physicians, medical command facilities and medical command facility medical directors will be certified and regulated by the Department. None of these were certified by the Department under the prior EMS act.

 • Physician assistants are provided a pathway, as nurses were afforded under the prior EMS act and continue to be afforded under the EMS System Act, to become EMS providers based upon their education and experience.

 • Standards are set forth as to when EMS providers are to have access to persons in need of EMS in a police incident and how police and EMS providers are to handle persons who need to be transported to a hospital for emergency medical care, but to whom the police also need access or to take into custody.

 • A peer review system is established for EMS providers and physicians who direct or supervise EMS providers.

 • EMS agencies will be empowered to provide community-based health promotion services that are integrated into the overall health care system.

 In developing this proposed rulemaking, the Department once again engaged the EMS community, including major stakeholder organizations, as well as other government agencies. The 2-year time period given to the Department to adopt final regulations did not afford the Department as much time to interact with these entities in developing this proposed rulemaking as the time the Department had to interact with them while spearheading the drafting of the EMS System Act. However, the Department did conduct approximately 40 stakeholder meetings throughout this Commonwealth and will continue to engage the stakeholders after the proposed rulemaking is published as it moves toward the adoption of final regulations.

Summary

 The proposed rulemaking contains the following seven chapters: Chapter 1021 (relating to administration of the EMS system); Chapter 1023 (relating to personnel); Chapter 1025 (relating to education); Chapter 1027 (relating to EMS agencies); Chapter 1029 (relating to medical command facilities and receiving facilities); Chapter 1031 (relating to complaints, disciplinary actions, adjudications and appeals); and Chapter 1033 (relating to special event EMS).

Chapter 1021. Administration of the EMS system

 This chapter would explain the purpose of the EMS system regulations, define terms used in the regulations, identify standards for the Statewide and regional EMS system plans, prescribe criteria for the Department's distribution of Emergency Medical Services Operating Fund (EMSOF) money, impose EMS data collection and reporting responsibilities, set standards for quality improvement programs, expand upon standards in the EMS System Act regulating vendors of EMS patient care report (PCR) software, address the peer review process conducted under the EMS System Act, establish standards for the integration of trauma facilities into the Statewide EMS system, explain and impose duties on the regional EMS councils, describe the relationship between the Department and the Advisory Board and impose standards for accessing and using for research data that is made confidential under the EMS System Act except for certain enumerated purposes.

Subchapter A. General provisions

 Part VII (relating to emergency medical services) is divided into two subparts. This proposed rulemaking would amend Subpart A (relating to EMS systems). Section 1021.1 (relating to purpose) would explain that the purpose of Subpart A is to employ the regulations in that subpart, consistent with the Department's rulemaking authority under the EMS System Act, to integrate the regional EMS systems into a unified Statewide system, improve the Statewide EMS system and coordinate the Statewide and regional EMS systems with similar systems in other states.

 Section 1021.2 (relating to definitions) would set forth definitions of various terms that would be used in the regulations. Some of the terms defined in the current regulations that were adopted under the prior EMS act would continue to be defined in this section. For the most part, they would be defined the same way. A number of terms defined in the regulations adopted under the prior EMS act are no longer relevant and would not be included in this section. Several terms would be new. Some terms would be derived from the EMS System Act.

 Section 1021.3 (relating to applicability) would explain that the regulations in Subpart A apply to persons and activities regulated by the Department under the EMS System Act.

 Section 1021.4 (relating to exceptions) would provide a process for persons to seek an exception to a regulatory requirement that is not also directly imposed by the EMS System Act. The process would be virtually the same as the regulation adopted under the prior EMS act regarding the granting of exceptions. Exceptions would be granted when the policy objectives and intentions of the Department as reflected in Subpart A are otherwise met or when compliance would create an unreasonable hardship and granting the exception would not jeopardize the health, safety or welfare of the public. This section would also address the Department granting an exception on its own initiative when the aforementioned standards are satisfied.

 Section 1021.5 (relating to investigations) would provide that the Department may investigate any person, entity or activity to ensure compliance with the EMS System Act and Subpart A.

 Section 1021.6 (relating to comprehensive EMS system plan) would provide for continued implementation and improvement of the Statewide EMS System Plan. The prior EMS act referred to the Statewide plan as a development plan. The need now is for a plan to continue to administer and improve the Statewide EMS system. In fact, the Statewide EMS Development Plan has already evolved into a plan such as this. This section would set forth what needs to be addressed in the plan and provide for the plan to be annually reviewed and updated as needed. Public notice of intended updates would be required and the public would be provided an opportunity to comment on proposed updates before the Department updates the plan. The Statewide plan would also incorporate regional EMS system plans after they are approved by the Department.

 The Statewide EMS System Plan would serve as a blueprint for how EMS problems are to be addressed and how EMS systems are to be maintained in the Commonwealth. Section 8112(a) of the EMS System Act (relating to contracts and grants) requires the Department to enter into contracts or grants with regional EMS councils for the initiation, expansion, maintenance and improvement of EMS systems which are in accordance with the Statewide EMS System Plan. This document, therefore, will also impact the Department's distribution of funds for EMS systems.

 Section 1021.7 (relating to comprehensive regional EMS system plan) would require each regional EMS council to develop and update a regional EMS system plan for coordinating and improving the delivery of EMS in the region for which the Department has assigned it responsibility. This section would state what needs to be addressed in a regional EMS system plan. It would also parallel proposed § 1021.6 relative to regional EMS councils giving notice to the public of proposed updates to the regional plan and an opportunity for comment before submitting the plan to the Department for approval. Since the regional plan would become part of the Statewide plan, and the Department's distribution of funds to regional EMS councils will be consistent with the Statewide plan, the regional EMS system plans would also affect the Department's distribution of funds for regional EMS systems.

 Section 1021.8 (relating to EMS data collection) would expand upon the Department's duty under section 8111(c) of the EMS System Act (relating to comprehensive plan) to collect and analyze EMS data for various purposes, including evaluating the effectiveness of the Statewide and regional EMS systems in reducing morbidity and mortality associated with responses to medical emergencies, aiding efforts to improve the Statewide and regional EMS system plans and facilitating the Department's ability to conduct investigations authorized under the EMS System Act. It would also address the statutory responsibility of persons regulated by the Department under the EMS System Act and dispatchers of EMS resources to cooperate with the Department directly, or through the regional EMS councils and the Advisory Board, in providing data as reasonably requested by them for these purposes.

Subchapter B. Award and administration of EMSOF funding

 Section 1021.21 (relating to purpose) would explain that the purpose of Subchapter B (relating to award and administration of EMSOF funding) would be to set forth the standards and criteria governing the award and administration of contracts and grants under the EMS System Act that are funded by EMSOF funds.

 Section 1021.22 (relating to entities eligible to receive EMSOF funds through contracts or grants) would identify the types of entities that are eligible to receive EMSOF money directly from the Department.

 Section 1021.23 (relating to award of contract or grant to a regional EMS council) would deal with EMSOF money provided to a regional EMS council by the Department. It would explain how a regional EMS council would be required to apply for those funds and the criteria a regional EMS council would need to satisfy to be awarded a contract or grant to use and distribute those funds. It would also convey, as authorized under section 8112(l) of the EMS System Act, that the Department, without undertaking a competitive bidding process, may enter into a new contract or grant with a regional EMS council if, in carrying out the prior grant or contract to oversee a regional EMS system, the regional EMS council demonstrated its ability and commitment to the Department's satisfaction to plan, maintain and improve the regional EMS system consistent with the terms of the contract or grant.

 Section 1021.24 (relating to use of EMSOF funding by a regional EMS council) would specify the various programs, vehicles, equipment and other items for which a regional EMS council is permitted to spend and distribute EMSOF money, and would identify certain uses of these funds that are not permitted. It would also clarify that for cost-savings purposes, regional EMS councils may make expenditures of funds on behalf of EMS agencies and certain other entities that operate in the regional EMS system, but that the Department may require matching funds in specified percentages as a condition for EMS agencies receiving, or regional EMS councils using, EMSOF funds for those purposes.

 Section 1021.25 (relating to allocation of EMSOF funds to regional EMS councils) would list the factors the Department would consider in determining the amount of EMSOF funds it would provide to a regional EMS council.

 Section 1021.26 (relating to technical assistance) would provide that a regional EMS council that receives a contract or grant from the Department may seek technical assistance from the Department to aid it in carrying out the contract or grant and that the Department will give special consideration to requests for technical assistance from regional EMS councils that serve rural areas.

 Section 1021.27 (relating to subcontracting) would permit a regional EMS council to subcontract some of its responsibilities, subject to prior approval by the Department.

 Section 1021.28 (relating to contracts and grants with the Advisory Board) would clarify that the provisions in Subchapter B that apply to grants and contracts between the Department and regional EMS councils do not apply to grants and contracts between the Department and the Advisory Board.

Subchapter C. Collection of data and information

 With few exceptions, an EMS agency is required to prepare an EMS PCR when it is called to provide EMS and encounters a patient or a person who has been identified as a patient and for whom an EMS provider is required to conduct a medical assessment. If the patient needs to be transported to a receiving facility, this report contains information essential for the continuation of care. The information the EMS PCRs contain for these patients and patients who are not transported to a receiving facility is also useful for quality improvement activities, peer review and EMS system planning. This subchapter would address the preparation of EMS PCRs, the reporting of essential patient information by EMS providers when they transport a patient to a receiving facility, prohibitions on the disclosure of EMS PCRs and the information contained therein and requirements imposed upon vendors who market software for the preparation of EMS PCRs.

 Section 1021.41 (relating to EMS patient care reports) would address an EMS agency's responsibility to complete an EMS PCR when it provides EMS and to provide the report to a regional EMS council. It would also impose a responsibility on an EMS provider who relinquishes primary responsibility for a patient to another EMS provider to provide the EMS provider who assumes primary responsibility for the patient with all patient information collected. It would further impose upon the EMS agency having primary responsibility for the patient during the transport to a receiving facility the duty to provide important patient information to the person at the receiving facility who assumes responsibility for the patient. It would require that for a patient who is transported to a receiving facility, before a complete EMS PCR needs to be completed, the transporting ambulance crew shall provide essential patient information to the receiving facility. The Department would publish, by notice in the Pennsylvania Bulletin, the types of information considered essential patient information. This abbreviated form is currently being field tested. The EMS agency would then be required to complete and provide the full EMS PCR to the receiving facility within 72 hours after concluding patient care and to subsequent patient caregivers within 24 hours after they make a request of the EMS agency, provided that the 24-hour time period would not expire before the initial 72-hour time period expires. It would further require an EMS agency to retain a copy of the EMS PCR for a minimum of 7 years.

 Section 1021.42 (relating to dissemination of information) would assert that an EMS PCR is a confidential document that may be disseminated only as set forth in that section.

 Section 1021.43 (relating to vendors of EMS patient care reports) would repeat some of the requirements in the EMS System Act pertaining to EMS PCR vendors and would also impose additional requirements on vendors of EMS PCRs and EMS PCR software. It would require EMS agencies to submit EMS PCRs using only a software program approved by the Department and it would require vendors of software marketed as appropriate for use in making EMS PCRs to first submit the software to the Department and secure the Department's approval of the software, and to do likewise if they make any substantive change to the software. This section would also make provision for the Department to change the data elements in an EMS PCR by publishing a notice of those changes in the Pennsylvania Bulletin at least 60 days prior to the changes going into effect. After publication of the changes, a vendor would not be able to market existing software for making EMS PCRs without disclosing that the software was approved before the changes were made and that it may only be used to make EMS PCRs until the changes go into effect. Restrictions would also be imposed upon a software vendor of EMS PCRs when it stores EMS PCR data on a server.

Subchapter D. Quality improvement and peer review

 This subchapter would address the Statewide EMS Quality Improvement Program, regional EMS quality improvement programs and peer review conducted under the EMS System Act.

 Section 1021.61 (relating to components of Statewide quality improvement program) would explain that the Statewide EMS Quality Improvement Program is operated to monitor and improve the delivery of EMS and that the Department, with the assistance of the Advisory Board, will identify the necessary components for a Statewide EMS Quality Improvement Program for the EMS system in this Commonwealth and update the Statewide EMS Quality Improvement Plan.

 Section 1021.62 (relating to regional quality improvement programs) would deal with regional EMS councils establishing and updating regional EMS quality improvement programs and would describe the different facets of those programs to be administered by the regional EMS councils.

 Section 1021.63 (relating to peer review) would identify EMS providers, EMS agency medical directors and medical command physicians as the persons who are subject to peer review under the EMS System Act. The definition of ''peer review'' in section 8103 of the EMS System Act (relating to definitions) classifies persons subject to peer review as ''[EMS] providers and physicians who direct or supervise EMS providers under [the EMS System Act] and regulations of the Department.'' EMS agency medical directors and medical command physicians are the physicians who direct and supervise EMS providers under the EMS System Act.

 The EMS System Act also states that the peer reviews are to be conducted by ''health care providers,'' but does not define the term. The Department consulted the Peer Review Protection Act (63 P. S. §§ 425.1—425.4) for guidance it could provide in this regard. The Peer Review Protection Act refers to each person empowered to conduct peer reviews under that act as a ''professional health care provider'' and defines these persons as ''individuals and organizations who are approved, licensed or otherwise regulated to practice or operate in the health care field under the laws of the Commonwealth....'' It then lists examples of these individuals and organizations. See the definition of ''professional health care provider'' in section 2 of the Peer Review Protection Act (63 P. S. § 425.2). The Department considered these examples in developing examples of health care providers who may conduct peer review under the EMS System Act.

 Section 1021.64 (relating to cooperation) would require entities regulated by the Department to cooperate with the Statewide and regional EMS quality improvement programs and, if requested, provide the Department and regional EMS councils the data, reports and access to records as reasonably requested by them to conduct quality improvement and peer reviews.

Subchapter E. Trauma centers

 This subchapter would be adopted to help the Department carry out its responsibility under section 8105(b)(12) of the EMS System Act (relating to duties of department) to integrate trauma centers into the Statewide EMS system.

 Section 1021.81 (relating to purpose) would explain that to accomplish this statutory objective the subchapter would provide for access to trauma centers and for the effective and appropriate utilization of EMS resources.

 Section 1021.82 (relating to requirements) would provide that to integrate trauma centers into the Statewide EMS system, trauma centers will be required to: 1) maintain a dedicated telephone number for communication between the trauma center and a transferring hospital; 2) implement outreach programs to provide education on the management of major and multiple systems trauma patients and the capabilities of the trauma center; 3) provide patient outcome and treatment information to the transferring facility and the EMS agency or agencies involved in providing EMS to the trauma patient; and 4) maintain a medical command facility to enable direct communication between the trauma center and the ambulance crew transporting the patient to the trauma center so that patient information and changes in patient condition are immediately available to the trauma center and medical consultation is immediately available to the transporting ambulance crew.

 Section 1021.83 (relating to complaints) would provide, as required under section 8105(b)(15) of the EMS System Act, that the Department will investigate complaints concerning the delivery of services by trauma centers and report the investigation results to the Pennsylvania Trauma Systems Foundation.

Subchapter F. Regional EMS councils

 The EMS System Act provides for the Department to divide this Commonwealth into EMS regions and to assign a regional EMS council to each EMS region to exercise certain responsibilities for the region, including helping the Department to carry out its responsibilities under the EMS System Act. See the definition of ''regional EMS council'' in section 8103 of the EMS System Act, section 8105(a) and (b)(2) of the EMS System Act and sections 8104(a)(9) and 8109(a) of the EMS System Act (relating to emergency medical services system programs; and regional emergency medical services councils). This subchapter would address the Department's designation of EMS regions and the assignment of regional EMS councils to those regions, the structure of regional EMS councils and the responsibilities of regional EMS councils.

 Section 1021.101 (relating to designation of regional EMS councils) would explain how regional EMS areas are designated.

 Section 1021.102 (relating to structure of regional EMS councils) would identify the types of entities that may serve as a regional EMS council. It would also prescribe certain structural requirements for a regional EMS council, including that it have a governing body and a director and a regional EMS medical director and that it establish committees as needed to carry out its responsibilities.

 Section 1021.103 (relating to governing body) would specify the representation requirements for a regional EMS council's governing body and core responsibilities of the governing body. It would also prohibit a staff member of a regional EMS council from serving as a voting member of the governing body.

 Section 1021.104 (relating to responsibilities of regional EMS councils) would list 19 specific duties of regional EMS councils, as well as the duty to perform other tasks as assigned by the Department. A few of these responsibilities would include assisting the Department in the collection and maintenance of data provided through EMS PCRs, assisting entities regulated by the Department under the EMS System Act in meeting responsibilities imposed upon them by the EMS System Act and regulations adopted by the Department under the EMS System Act, and monitoring entities regulated under the EMS System Act to determine whether they are in compliance with the responsibilities imposed upon them by the EMS System Act and the regulations.

Subchapter G. Advisory Board

 As previously noted, the EMS System Act designates the board of directors of PEHSC as the Advisory Board to the Department on EMS matters. Among its other responsibilities, the Advisory Board is to serve as the forum for discussion of the content of the Statewide EMS System Plan and advise the Department on EMS policy and regulations. The Advisory Board is funded with EMSOF funds, which it would secure through grants and contracts with the Department.

 Section 1021.121 (relating to duties and purpose) would address the responsibilities of the Advisory Board. It would also prescribe certain structural requirements of the Advisory Board, including that it have a governing body and a director and that it establish committees, including a medical advisory committee and an EMS for children advisory committee, as needed to carry out its responsibilities.

 Section 1021.122 (relating to meetings and members) would set forth certain requirements for Advisory Board meetings and membership.

 Section 1021.123 (relating to disasters) would prescribe roles for the Advisory Board when this Commonwealth is confronted with a disaster, mass casualty event or other substantial threat to the public health and safety.

Subchapter H. EMS research

 As previously noted, in general, EMS agencies are to prepare an EMS PCR for each patient to whom they provide EMS and they are to forward these reports to regional EMS councils. Section 8106(e) of the EMS System Act (relating to emergency medical services patient care reports) provides that these reports and the information in them are confidential except for certain purposes. One of the purposes for which the information may be released is for research approved by the Department, subject to Department approval and supervision to ensure that the use of the information is strictly limited to the approved research. See section 8106(e)(2) of the EMS System Act. Additionally, the Department may collect data regarding patients who utilize emergency departments, in a manner that protects the confidentiality of patient records, but the Department may also permit the use of such data for limited purposes, including research. See section 8105(b)(4) of the EMS System Act. This subchapter would be comprised of a single regulation, § 1021.141 (relating to research). This regulation would specify the process for procuring Department approval for use of the information for research under both provisions.

Chapter 1023. Personnel

 This chapter would address qualifications and responsibilities of persons to whom the EMS System Act assigns specified roles and responsibilities in the Statewide EMS system.

Subchapter A. Administrative and supervisory EMS personnel

 This subchapter would identify the categories of physicians to whom the EMS System Act assigns administrative and supervisory responsibilities in the administration of the Statewide and regional EMS systems. As stated in section 8102 of the EMS System Act (relating to declaration of policy), these systems serve as health care safety nets for many people in this Commonwealth and are to be fully integrated with the overall health care system to identify, modify and manage illness and injury. Physicians with appropriate qualifications are given essential functions in these EMS systems to ensure that those systems operate as intended with respect to ensuring that the EMS needs of persons who require EMS are met.

 Section 1023.1 (relating to EMS agency medical director) would establish the responsibilities of and the minimum qualifications for physicians to act as EMS agency medical directors. Every EMS agency will be required to have a medical director, known as the EMS agency medical director. It will be the responsibility of this physician to evaluate the competence of EMS providers who work for the EMS agency, to evaluate the quality of patient care provided by the EMS agency and to provide medical guidance and advice to the EMS agency and its EMS providers. If an EMS agency medical director determines that an EMS provider at or above the advanced emergency medical technicians (AEMT) level has not maintained competence in performing skills at the level the EMS provider is certified, the EMS agency medical director will be responsible for specifying the level of practice in which the EMS provider may engage for the EMS agency. An EMS agency medical director will also be responsible for being acquainted with the Statewide and other Department-approved EMS protocols that apply to the EMS agency with which that physician is associated and for ensuring that the EMS agency's EMS providers are familiar with the protocols that apply to the delivery of EMS within their scope of practice.

 Section 1023.2 (relating to medical command physician) would establish the responsibilities of and the minimum qualifications for physicians to act as medical command physicians. Medical command physicians are the physicians who provide EMS providers medical direction, generally by radio, when they seek direction while providing EMS to patients. This may occur because the EMS provider believes that medical direction is needed or helpful or because applicable EMS protocols dictate contact with medical command under the circumstances presented. These physicians, like EMS agency medical directors, shall be familiar with the Statewide and other relevant Department-approved protocols. They would generally be required to provide medical direction to EMS providers consistent with these protocols, but they would have the authority to depart from the protocols when there is good cause to do so. To serve as a medical command physician, a physician would need to be certified by the Department. A medical command physician would also need to register that certification with the Department at 3-year intervals and would need to meet specified requirements to do so.

 Section 1023.3 (relating to medical command facility medical director) would establish the responsibilities of and the minimum qualifications for physicians to act as medical command facility medical directors. Medical command physicians function under the auspices of a medical command facility and under the direction and supervision of a medical command facility medical director. The medical command facility medical director would be responsible for ensuring that the medical command physicians who operate under the auspices of the medical command facility are carrying out the regulatory responsibilities that would be imposed upon them and are providing appropriate medical direction to EMS providers. The medical command facility medical director would also be responsible for ensuring that the medical command facility is compliant with its statutory and regulatory responsibilities. Like the medical command physician, to serve as a medical command facility medical director a physician would need to be certified by the Department and would be required to register that certification with the Department at 3-year intervals by satisfying the registration requirements that would be imposed by the regulations.

 Section 1023.4 (relating to regional EMS medical director) would establish the responsibilities of and the minimum qualifications for physicians to act as regional EMS medical directors. This Commonwealth is currently divided into 16 EMS regions. For each of these regions, the Department has designated and contracted with an entity to serve as a regional EMS council. Each regional EMS council would assist the Department in administering the EMS System Act. Some of a regional EMS council's activities, such as the quality improvement reviews, require medical oversight. There are other matters in which a regional EMS medical director is involved and called upon to provide medical leadership. These responsibilities would continue to apply.

 Section 1023.5 (relating to Commonwealth EMS Medical Director) would establish the responsibilities of and the minimum qualifications for a physician to qualify as the Commonwealth EMS Medical Director. The Commonwealth EMS Medical Director (currently referred to as the Commonwealth Emergency Medical Director) is a physician who is approved and employed by the Department to advise it and formulate policy on EMS matters. Some of the responsibilities of the Commonwealth EMS Medical Director would be to lead the development and amendment of Statewide EMS protocols, to assist in the development and implementation of a Statewide EMS quality improvement program and to serve as the Department's medical liaison to the regional EMS medical directors and the medical advisory committees of the regional EMS councils and the Advisory Board.

Subchapter B. EMS providers and vehicle operators

 The persons who provide EMS to persons in need of EMS are the EMS providers (referred to in the current regulations as ''prehospital personnel''). EMS providers, with appropriate equipment and supplies, are generally transported by ambulance to scenes where their services are required. Persons who drive ambulances and certain other ground EMS vehicles, such as squad vehicles, are EMSVOs. Many EMS providers will also be EMSVOs. This subchapter would identify the various classes of EMS providers and address their roles and responsibilities, the requirements they need to satisfy to become certified and to maintain current registration of their certification and the skills they will be permitted to perform. It would also address the role of EMSVOs and the requirements they will need to satisfy to become certified and maintain current registration of their certification.

 Section 1023.21 (relating to general rights and responsibilities) would address various rights given to and various responsibilities imposed upon EMS providers and EMSVOs. Most of these rights and responsibilities are in the EMS System Act. This section would require EMS providers and EMSVOs to ensure that the Department has their current mailing address, regardless of whether they maintain current registration of their certifications. It would also require EMS providers and EMSVOs, as well as applicants for EMS provider and EMSVO certifications, to report to the Department various matters that the Department may take into consideration in acting upon applications for certification and in evaluating whether disciplinary sanctions should be pursued against EMS providers and EMSVOs. Matters that need to be reported under the EMS System Act include various types of convictions, disciplinary sanctions and exclusions from Federal and State health care programs. Section 8113(i)(3) of the EMS System Act (relating to emergency medical services providers) requires that the Department be provided certified copies of records of these matters and prohibits the Department from certifying an applicant if the Department does not receive a certified copy of the relevant document unless the applicant establishes that the document does not exist. This section would explain those requirements.

 This section would also repeat various examination rights and responsibilities of persons seeking to become EMS providers that are imposed by statute, impose upon EMS providers and EMSVOs the responsibility to display their certification credentials when requested while providing EMS or operating an EMS vehicle and require EMS providers other than prehospital EMS physicians (PHP) to provide EMS only under EMS protocols and medical command direction.

 Each section of the EMS System Act that pertains to the certification of an EMS provider includes a provision which states that if that person does not renew the registration of the person's EMS provider certification before it expires, the EMS provider may renew the registration at a later date under standards the Department prescribes by regulation. With few exceptions, the EMS System Act gives an EMS provider the option of timely renewing a registration by either satisfying continuing education requirements or passing written and practical skills registration examinations. To renew a registration within the 2 years after its expiration, this section would require an EMS provider to complete both core continuing education requirements that the Department prescribes and the written registration examination. If more than 2 years have elapsed since the expiration of a registration before the EMS provider seeks to renew the registration, the EMS provider would need to complete the core continuing education requirements that the EMS provider had missed during the period of time the provider's certification was not renewed and would also need to pass both the written and practical registration examinations. Prehospital physician extenders (PHPE), prehospital registered nurses (PHRN) and PHPs will not have the option of taking examinations to secure timely renewal of the registration of their certifications. However, if they would seek to renew their registrations after the registrations expire, they would need to take and pass the same registration examinations as paramedics to obtain a current registration.

 Special provisions are included in section 8113(o) of the EMS System Act for EMS providers and EMSVOs who are unable to satisfy the standard continuing education option for renewing the registration of their certification because they are in the armed forces and are on an active tour of duty. Subsection (d) would provide that if their registrations expire during their tour of duty or will expire within 12 months after their return from military service, they may secure an exception to the continuing education requirements from the Department. The Department could give them an extension of time to meet the continuing education requirements. EMS providers could also secure the Department endorsement of their relevant military service as satisfying some or all of their continuing education requirements. The Department's regulation would provide for the Department to address requests for an exception on a case-by-case basis.

 Section 8113(o) of the EMS System Act also provides that an EMS provider in military service who is certified at or above the AEMT level who returns from active duty shall have the provider's competency in providing EMS evaluated by an EMS agency medical director before the EMS provider is permitted to perform skills for the EMS agency with which the EMS agency medical director is associated. The regulation would also state this requirement.

 Another topic that would be addressed in this section would be the potential downgrading of the level of care an EMS provider is permitted to provide for an EMS agency based upon an assessment of the EMS provider's competency by the EMS agency medical director. Section 8125(b) of the EMS System Act (relating to medical director of emergency medical services agency) provides that an EMS agency medical director is to conduct, for the EMS agency with which the physician is associated, initial and annual assessments of the knowledge and skills competency an EMS provider, at or above the AEMT level, shall possess to perform EMS at that level for the EMS agency. Section 8129(k) of the EMS System Act (relating to emergency medical services agencies) provides that if an EMS agency medical director apprises the EMS agency that the EMS provider is not competent to provide services at the level at which the EMS provider is certified, the EMS agency may not permit the provider to practice at that level, but may permit the provider to practice at a lower level if authorized to do so by the EMS agency medical director. Section 8113(m) of the EMS System Act would give an EMS provider at or above the AEMT level who has been assessed as being deficient in skills at the level for which the EMS provider is certified the option to either continue to meet the registration requirement for the provider's level of certification or to apply for and secure certification at the lower EMS provider level. Subsection (g) would expand upon these options. It would further provide that an EMS provider who transitions to a lower level of certification or practice may not display any indicia of higher level certification when providing EMS at the lower level and that the EMS provider shall disclose the downgrade to each EMS agency for which the provider is providing EMS or seeks to provide EMS, as well as to the regional EMS councils responsible for the EMS regions in which those EMS agencies are headquartered.

 Finally, subsection (i) would address the rights and responsibilities of an EMS provider with respect to providing EMS to a patient when arriving at the scene of a police incident where a law enforcement officer is present and is exercising control over the scene.

 Section 1023.22 (relating to EMS vehicle operator) would address standards for the certification of an EMSVO, the recurring registrations of that certification and the activity in which an EMSVO is authorized to engage. Prior to the enactment of the EMS System Act, there was no statutory authority for the Department to certify and regulate the activity of persons entrusted with driving an ambulance, or what is now referred to as a squad vehicle. Section 8122 of the EMS System Act (relating to emergency medical services vehicle operators) confers that authority on the Department for the first time. Under this section, the certification and registration would permit an EMSVO to operate any ground EMS vehicle the EMS agency authorizes the operator to drive. The registration period, in general, would be for 3 years. However, if the EMSVO is also certified as an AEMT or higher level EMS provider, the registration period will be 2 years. If the EMSVO is certified as any type of EMS provider the registration period for the EMSVO certification would coincide with the registration period for the EMS provider certification. The registration could be renewed by completing the requisite continuing education, which would be two or three credits, depending upon the length of the registration period involved. Under section 8122 of the EMS System Act, an EMSVO who operates an EMS vehicle only for an EMS agency's QRS would not have registration requirements to satisfy.

 Sections 1023.23—1023.30 would pertain to EMS providers that will be certified by the Department. Section 1023.23 (relating to ambulance attendant and first responder) would deal with the elimination of the ambulance attendant and first responder classifications under the prior EMS act and the transition of these persons to EMR certification under the EMS System Act. First responders are the lowest level EMS providers currently certified. Ambulance attendants are persons who meet some very minimal requirements under the prior EMS act under which they are permitted to attend to patients as part of an ambulance crew and perform certain basic life support (BLS) skills. Currently, ambulance attendants are not certified or otherwise regulated by the Department. The Department's only regulation of their conduct is indirect and derives from the Department's authority to regulate ambulance services. This changed under the EMS System Act. Ambulance attendant and first responder personnel classifications are abolished and these providers become EMRs. This section would provide for the automatic issuance of EMR certifications to first responders and would give ambulance attendants 180 days to provide documentation to the Department to establish that they have been ambulance attendants and are, therefore, qualified for EMR certification. The section would further provide for the automatic registration of the EMR certifications when those certifications are issued to the former first responders and ambulance attendants and for the initial registrations to expire when their certification as a first responder and qualifications as an ambulance attendant would have expired under the prior EMS act.

 Sections 1023.24—1023.30 are primarily structured in the same fashion and each would deal with a specific type of EMS provider. Each section would address the roles and responsibilities of the EMS provider to which it applies, the criteria for certification of that EMS provider, the standards for the registration of that certification and the scope of practice of the EMS provider. The EMS providers would be EMRs, emergency medical technicians (EMT), AEMTs, paramedics, PHPEs, PHRNs and PHPs. Each subsection dealing with scope of practice would identify the primary skill areas for the EMS provider and would provide that the specific skills that type of EMS provider would be permitted to perform would be specified through a notice in the Pennsylvania Bulletin. The scope of practice of each higher level EMS provider, through paramedics, would include the scope of practice of the immediately lower level EMS provider as well as additional skills.

 Section 1023.26 (relating to advanced emergency medical technician) would deal with a new level of EMS provider in this Commonwealth, which will be an intermediate level EMS provider certified to perform the skills an EMT is certified to perform, plus additional advanced life support (ALS) skills, as designated by the Department, which include interventions and administration of medications with certain advanced equipment. Many other states also certify an EMS provider between the EMT and paramedic levels that is authorized to perform all of the skills an EMT is certified to perform and some of the additional ALS skills a paramedic is certified to perform. Some states label this EMS provider an ''advanced EMT'' and other states label this EMS provider an ''EMT—intermediate'' or ''EMT-I.'' Medicare regulations employ the term EMT—Intermediate and define that EMS provider within the definition of ''advanced life support personnel'' in 42 CFR 414.605 (relating to definitions), as follows:

An individual who is qualified, in accordance with State and local laws, as an EMT-Basic and who is also qualified in accordance with State and local laws to perform essential advanced techniques and to administer a limited number of medications.

 When the Department begins to certify AEMTs, an AEMT will be an EMS provider who satisfies the Medicare definition of ''EMT—Intermediate.''

 PHPEs, PHRNs and PHPs would be physician assistants, registered nurses and physicians who qualify for certification as EMS providers by virtue of their health care practitioner licenses and by satisfying additional requirements. As specified in sections 8118 and 8119 of the EMS System Act (relating to prehospital registered nurses; and prehospital physician extenders), PHPEs and PHRNs would have the same scope of practice as a paramedic, plus they would be permitted to perform skills within the scope of their licenses provided that they received authority to perform those skills through EMS protocols or under the orders of a medical command physician. PHPs would be able to perform physician skills within the scope of the physician's practice without restrictions. Additionally, as provided for in section 8113(g) of the EMS System Act, these sections would make provision for the Department to expand the list of skills each type of EMS provider may perform under protocol or medical command order through publication of a notice in the Pennsylvania Bulletin.

 Except as already noted for ambulance attendants and first responders who become EMRs, the initial and subsequent registration period for EMR and EMT certifications is 3 years and the registration period for all other EMS provider certifications is 2 years. Each section would specify criteria for the certification of the EMS provider to which it applies and for registration of the EMS provider's certification. The initial registration would begin with the certification of the EMS provider. The term of the initial registration would vary depending upon factors explained in each regulation. Subsequent registration periods for the EMS providers would be for the standard 2 or 3 years, depending upon the type of EMS provider involved.

 For various types of EMS providers who are certified or otherwise permitted to practice under the prior EMS Act, this section would provide a grace period to accommodate those providers being able to continue to function pending their certification as a new type of EMS provider. This would apply to ambulance attendants becoming EMRs and health professional physicians becoming PHPs.

 Finally, both the level of practice and the types of services in which each type of EMS provider may participate would be defined in general terms.

 Section 1023.31 (relating to continuing education requirements) would specify the continuing education requirements each type of EMS provider and an EMSVO would need to meet to secure timely registration of their certifications if they sought to renew their certifications by satisfying continuing education requirements. EMRs, EMTs, AEMTs and paramedics would have the option of securing a new registration by taking and passing registration examinations instead of satisfying continuing education requirements. PHPEs, PHRNs and PHPs would not have that option. For the EMSVO and each type of EMS provider, this section would specify the total number of continuing education credits needed as well as a lesser number of core continuing education requirements in designated subject matter or courses, within the total number of credits, that the Department would specify through a notice in the Pennsylvania Bulletin.

 Section 1023.32 (relating to credit for continuing education) would specify the types of courses for which credit would be awarded by the Department and the manner in which the Department would assign credit to those courses. It would also provide for the creation of a Statewide registry of continuing education records that EMSVO and EMS providers may access to secure their own record through a secure access process and would establish a procedure for them to resolve discrepancies between their records of the continuing education they completed and the record in the registry.

 Section 8113(f) of the EMS System Act authorizes the Department to issue EMS provider certifications and registrations through reciprocity or endorsement. To grant an EMS provider certification or registration through endorsement, the Department would endorse an examination or an educational course that an applicant for EMS provider certification, or registration of an EMS provider certification, has taken as meeting or exceeding the standards the Department imposes for the certification and registration examinations and courses it approves. To grant an EMS provider certification through reciprocity, the Department would review the criteria for EMS provider certification in another state, determine if the other state's criteria was substantially equivalent to the criteria for a similar certification the Department issues and then enter into an agreement with its counterpart certifying agency in the other state that each will issue a certification to an applicant similarly certified in the other state.

 Sections 1023.33 and 1023.34 (relating to endorsement of course or examination; and reciprocity) would set forth the standards for the Department to grant endorsement of courses and examinations for EMS provider certification and registration purposes and for the Department to grant EMS provider certifications predicated on a reciprocity agreement with another state. The section dealing with reciprocity would include the caveat that a reciprocity agreement with its counterpart in another state would not deprive the Department of its right to deny reciprocal certification to an applicant based upon disciplinary considerations.

Subchapter C. Other persons associated with the Statewide EMS System

 In addition to EMS providers and EMSVOs and the physicians who direct and supervise them, EMS instructors and rescue technicians and instructors are integral to an EMS system. Issues regarding them are addressed in these regulations generally and, specifically, in this subchapter.

 EMS instructors teach courses in EMS educational institutes. In § 1025.1(h) (relating to accreditation and operational requirements of EMS educational institutes), the Department would impose upon the EMS educational institutes the standards their instructors would need to satisfy. Section 1023.51 (relating to certified EMS instructors) would set standards for persons to be certified as EMS instructors by the Department. Like EMS providers and EMSVOs, their certifications will be subject to a registration requirement. The regulation would also include requirements for the registration of their certifications. A certified instructor will not be able to teach under the certification unless it is currently registered. However, as discussed under § 1025.1, not all of an EMS educational institute's instructors need to be certified as EMS instructors by the Department.

 Rescue technicians function hand-in-hand with EMS providers. Frequently persons who require EMS need to be rescued from vehicles or other places where they may be entrapped. The Department does not regulate rescue personnel, but as the lead agency for EMS in this Commonwealth, it, in collaboration with the State Fire Commissioner, has developed rescue technician courses and a rescue technician certification process to promote the proper education and training of persons who would seek to free entrapped persons. Section 1023.52 (relating to rescue personnel) would continue the rescue technician certification program provided for in the current regulations. As is the case now, participation in the program in offering rescue technician training courses, or in serving as an instructor or completing the rescue technician certification process, would be entirely on a voluntary basis. Subsection (e) would make it clear that participation in the program would not be required to offer a rescue training program, teach a rescue course or perform rescues.

Chapter 1025. Education

 Some persons who now qualify for EMS provider certification, such as some registered nurses and physicians, receive the education they need to serve as an EMS provider through the courses they took to be licensed as nurses and physicians and the continuing education courses they took to improve their skills. Under the EMS System Act, they, as well as physician assistants, will be tested to ensure that they are competent to be certified as EMS providers. Other persons need to take EMS provider education courses to meet the educational requirement for certification. Under section 8105(a)(6) of the EMS System Act, the Department is required to define and approve educational programs and accredit educational institutes for the education and training of EMS providers. In this chapter, the Department would establish accreditation and operational standards for EMS educational institutes and sponsors of continuing education programs for EMS providers and EMSVOs.

Subchapter A. EMS educational institutes

 Section 1025.1 would impose the accreditation and operational requirements for EMS educational institutes. This section would address the types of entities eligible to become accredited and reaccredited as an EMS educational institute, the institute's duty to establish an advisory committee and the responsibilities of that advisory committee, and the responsibilities of the institute with respect to its administration and operation, and the instruction it provides.

 There would be two types of EMS educational institutes—an ALS educational institute and a BLS educational institute. The institutes would be classified, as explained in subsection (b), based upon the courses they would provide. Some of the standards for the accreditation and operation of an EMS educational institute would be different based upon the ALS or BLS classification of the institute. Of course, some ALS institutes also provide BLS courses. Those institutes would primarily be held to the higher standards for ALS institutes, but, as to some matters, to lesser standards with respect to the EMR and the EMT courses they offer.

 Each EMS educational institute would need to have a medical director, an administrative director, a course coordinator for each EMS provider educational course it offers, EMS instructors, clinical preceptors and field preceptors, as appropriate. The section would specify the qualifications each would need to satisfy and impose upon each certain duties. The EMS educational institute would be responsible for ensuring that these standards were met. Subsection (c) would specify the responsibilities of the advisory committee.

 Additionally, this section would enumerate matters the EMS educational institute would need to disclose to students and prospective students and would prescribe various facility, equipment, supply and other operational requirements.

 Standards regarding the EMS educational institute's use of instructors would be imposed, but would be flexible. At least 75% of the instruction would need to be provided by persons certified by the Department as EMS instructors. They would need to have a prescribed number of years' experience as an EMS provider and as an EMS instructor in teaching a course at or above the level of EMS provider certification they would be teaching. Alternatively, the regulation would permit the EMS educational institute to fill this 75% teaching quota with persons approved by the institute's medical director and course coordinators as meeting or exceeding the certification requirements. The remaining 25% of the education in the EMS provider educational courses offered could be provided by other persons if they have special expertise in the subject matter they would be teaching, as determined by the medical director in consultation with the course coordinators.

 This section would also include a provision requiring the EMS educational institute and an applicant for accreditation as an EMS educational institute to provide the Department or a regional EMS council with access to its records and its facility, for inspection purposes, to monitor its compliance with the requirements of the subchapter.

 Finally, as many EMS educational institutes will be operating within a 3-year accreditation cycle when this regulation goes into effect, and will be operating under standards different than those that would be imposed by this section, subsection (l) would provide that the standards imposed by the section would not apply to an EMS educational institute until it makes its initial application for accreditation after the regulation becomes effective.

 Section 1025.2 (relating to accreditation process) would address the procedure to apply for accreditation as an EMS educational institute and explain how that application would be processed. It would also identify the accreditation decisions that could be reached from full accreditation to nonaccreditation and explain what each classification entails. The procedures for appealing a decision denying or granting conditional accreditation would be addressed in § 1031.12 (relating to discipline of EMS educational institutes). The provisions for denials of license, accreditations and certification, and disciplinary actions against entities that are licensed, certified or accredited under the EMS System Act and this subpart would be in that chapter.

 Section 1025.3 (relating to advertising) would preclude an entity from advertising a course in a manner that states or suggests that the successful completion of the course satisfies the EMS educational course requirement for EMS provider certification, unless the entity has been accredited by the Department as an EMS educational institute and the course has been approved by the Department for that purpose. It would also impose requirements with respect to language that needs to be inserted in the accredited institute's brochures and registration materials relating to offering the course.

Subchapter B. EMS continuing education courses

 As previously stated, some types of EMS providers have the option of renewing the registrations of their EMS provider certifications by either satisfying continuing education requirements or taking registration renewal examinations. The sections of the EMS System Act that address the registrations of these certifications each provide for the registrations to be secured by the EMS provider or EMSVO securing credits in continuing education programs approved by the Department.

 Section 1025.21 (relating to accreditation of sponsors of continuing education) would establish the standards for entities to become a sponsor of continuing education programs and for those entities to become reaccredited as continuing education sponsors.

 Section 1025.22 (relating to responsibilities of continuing education sponsors) would address the administrative responsibilities that continuing education sponsors would need to satisfy. It would address matters such as maintaining a record of attendance for courses given in a classroom setting, the reporting of attendance, evaluating courses to determine their effectiveness, retaining records and providing access to those records for the Department review, monitoring compliance with responsibilities and reporting to the Department an EMS provider's or EMSVO's completion of a continuing education course. In the past, some continuing education sponsors have offered a continuing education course that another sponsor has developed without notifying the Department that it was offering the course. The Department would then receive notification of course completion by EMS providers when the Department did not have a record of the course being given by a continuing education sponsor. Consequently, this section would also include a provision requiring that before a continuing education sponsor may offer for continuing education credit a course developed by it or another continuing education sponsor, it must register with the Department the location where it will offer that course. If the course is completed by an EMS provider or EMSVO without the continuing education sponsor first registering the course with the Department, the Department would give the EMS provider or EMSVO credit for completing the course unless upon review the Department finds that the course was presented in a manner that rendered it unacceptable for credits. In that case, the Department would likely take disciplinary action against the continuing education sponsor for failing to comply with this regulation.

 Section 1025.23 (relating to advertising) would feature the same types of provisions that § 1023.3 would contain in regulating the advertisement of EMS provider educational programs by EMS educational institutes. It would also provide that a continuing education sponsor may not advertise a course for continuing education credit unless the sponsor has been approved by the Department to offer the course.

Chapter 1027. EMS agencies

 This chapter would address the licensing and regulation of EMS agencies. Under the prior EMS act, the Department licensed ambulance services. The licensure standards in the prior EMS act were directed to the ambulance services' operation of ambulances and squad vehicles, which, under the prior EMS act, were also considered to be ambulances. In developing the EMS System Act, the General Assembly recognized the need to provide for an EMS system far more evolved and sophisticated than one confined to the operation of ambulances. Consequently, it provided for the licensing of EMS agencies that would be empowered to conduct a variety of EMS operations based upon their focus and qualifications. While under the prior EMS act the term ''ambulance service'' referred to an organization that operates ambulances, under the EMS System Act the term ''ambulance service'' refers to a type of EMS service an EMS agency may be licensed to provide. Under the EMS System Act, an entity does not need to operate an ambulance service to be licensed as an EMS agency, but if it provides any of the myriad of EMS services described in the EMS System Act it will need to be licensed as an EMS agency and will be subject to the EMS System Act and the Department's regulations place on EMS agencies.

Subchapter A. General requirements

 Subchapter A (relating to general requirements) would include sections that apply to EMS agencies, regardless of the services they are licensed to provide.

 Section 1027.1 (relating to general provisions) would specify types of EMS operations for which an entity would need an EMS agency license. It would address, in general terms, the requirements an applicant would need to satisfy to qualify for an EMS agency license and the type of information that would be included on the license and license registration documents the Department would issue to EMS agencies. Additionally, it would include provisions facilitating the transition to EMS agency licensure of ambulance services and QRSs that are currently operating under a license or other authorization issued under the prior EMS act.

 Section 1027.2 (relating to license and registration applications) would deal with applications for EMS agency licenses, as well as the amendment and the triennial registration of those licenses. It would specify some of the information that would be solicited in the license application form and provide direction regarding where an applicant is to submit its license application. It would provide that applications for a license, amendment of a license and registration of a license are to be filed with a regional EMS council and it would explain how the applicant would determine the regional EMS council to which it is to submit these applications. It would also explain how a regional EMS council would process a license application. Additionally, it would identify the types of changes to an EMS agency's operations that would require an EMS agency to secure an amendment of its license.

 Section 1027.3 (relating to licensure and general operating standards) would address various requirements that an applicant for an EMS agency license and an EMS agency would need to satisfy. Unlike § 1027.1, which would deal with the requirements for the issuance of an EMS agency license, the primary focus of this section would be operational standards an EMS agency would need to satisfy when it is providing EMS. One of the topics addressed is the records that would need to be made available to the Department or a regional EMS council for inspection by an applicant for an EMS agency license and by an EMS agency after it is licensed. An EMS agency, once it begins operations, would be required to make available for inspection certain records in addition to those it was required to make available for inspection when it applied for licensure. This section would also impose upon EMS agencies duties pertaining to vehicles, equipment, supplies, staffing, the use of persons under 18 years of age, interacting with public safety answering points (PSAP), patient management, use of lights and warning devices, dispatching, exclusion of weapons and explosives, reporting of EMS vehicle accidents, reporting of injuries and fatalities incurred by EMS providers in the line of duty, committees, EMS provider credentialing, display of license and registration certificates, monitoring compliance by the agency and its staff with requirements of the EMS System Act and the regulations, and establishing and adhering to certain policies and procedures.

 The EMS agency dispatching requirements would apply to only those EMS agencies that operate a communications center to which a PSAP routes callers for the EMS agency to carry out the PSAP dispatching function, or which advertises a number to the public through which the public can seek an emergency EMS response instead of calling a PSAP. Under section 8129(i) of the EMS System Act, the call takers and dispatchers at a dispatch center would need to satisfy the requirements imposed upon call takers and dispatchers by 35 Pa.C.S. § 5303(a)(6) (relating to telecommunications management). The Department has coordinated with PEMA for PEMA to certify and recertify those call takers and dispatchers if the requisite standards are met. This section would set forth the standards for the certification and recertification of those persons as well as quality assurance and other standards that an EMS agency dispatch center would need to satisfy. It would also require an EMS agency dispatch center to employ the emergency medical dispatch program used by the 911 emergency communications center of the county in which the EMS agency dispatch center is located. However, in extraordinary cases, the EMS agency could seek an exception under § 1021.4 to use another dispatch program. Under § 1023.1, if an EMS agency operates an EMS agency dispatch center its medical director will be required to provide medical direction for the dispatch center.

 Section 1027.4 (relating to medication use, control and security) would set standards for an EMS agency's use of medications. It would provide that the Department will publish at least annually in the Pennsylvania Bulletin a notice listing the medications approved for use by EMS providers at their various certification levels. The notice would list the medications that an EMS agency is required to stock based upon the type of EMS service it is licensed to provide. It would also address the scope of authority of each type of EMS provider to administer medications to patients and it would impose upon an EMS agency various responsibilities with respect to monitoring and directing the use, control and security of the medications it is authorized to stock.

 Section 1027.5 (relating to Statewide EMS response plan) would establish Statewide exceptions to the general requirement that an EMS agency provide its services 24 hours-a-day, 7 days-a-week. Section 8140 of the EMS System Act (relating to conditional temporary licenses) authorizes an EMS agency to depart from this requirement if it participates in a county-wide or larger area-wide EMS response plan approved by the Department that permits otherwise. Section 1027.5 would exempt EMS agencies that provide an air ambulance service from providing those services every day around the clock. It would also provide a different response requirement for an EMS agency's operation of a tactical EMS service.

 Section 1027.6 (relating to EMS vehicle fleet) would deal with the EMS vehicles an EMS agency is authorized to use. It would require that a vehicle pass an EMS vehicle inspection by the Department or regional EMS council inspector before it may be used as an EMS vehicle and it would provide for the placement on an EMS vehicle that passes the inspection of decals with date stripes to reflect the date of inspection and the expiration date. Certain exceptions would be provided for a vehicle deployed as an EMS vehicle for a short temporary period. This section would also address the steps an EMS agency would need to take before adding an EMS vehicle to its fleet or permanently or temporarily replacing an EMS vehicle. To operate a temporary replacement EMS vehicle, the EMS agency would need to submit a temporary change of vehicle form in which it would attest to the fact that the vehicle satisfies the requirements applicable to the type of EMS vehicle for which it will be used. Upon receiving that form, a regional EMS council would issue a letter authorizing the use of the replacement vehicle for a short period of time. An EMS agency that wants to add an EMS vehicle to its fleet would need to apply for an amendment of its license. The section would also require the inspection of an EMS agency's EMS vehicles as part of the process of an EMS agency securing the triennial registration of its license. It would also specify the circumstance in which an EMS agency will be required to remove the decals from an EMS vehicle. Finally, this section would enumerate requirements that are applicable to all ambulances.

 Section 1027.7 (relating to removal of EMS vehicles from operation) would require an EMS agency to immediately remove an EMS vehicle from operation when there is a mechanical or equipment problem that poses a significant threat to the safety of patients or crew and to not again use the vehicle until the problem has been corrected. It would further provide that if after inspection the Department directs that an EMS vehicle be removed from operation, the EMS agency may not again operate that vehicle until the Department has confirmed to the EMS agency that the Department is satisfied that the problem has been resolved.

 Section 1027.8 (relating to right to enter, inspect and obtain records) would address the responsibility of an EMS agency or an applicant for an EMS agency license to permit an employee or agent of the Department to inspect its records, EMS vehicles, supplies, equipment and security facilities to ensure that the EMS agency or applicant is in compliance with its duties under the EMS System Act and the regulations. It would also require the EMS agency or applicant to permit the copying of certain records. Section 8142(a)(1) of the EMS System Act (relating to emergency medical services agency license sanctions) provides that the failure of an EMS agency or an applicant for an EMS agency license to comply with a the Department regulation is a ground for discipline, including refusing to issue an EMS agency license to an applicant. Section 1027.8(c) would emphasize that failure to comply with this regulation would be a ground for an action.

 Section 1027.9 (relating to notification of deficiencies to applicants) would address the process for dealing with an application for an EMS agency license, the registration of a license and an amendment of a license when the inspection that follows receipt of the application reveals deficiencies. The section would provide that the inspector will give the applicant an inspection report and, if there are deficiencies, identify whether a reinspection or plan of correction will be required or whether the problem can be resolved without the need for either. It would further address the applicant's right to dispute a deficiency cited by an inspector or a regional EMS council's rejection of its plan of correction, and to have the Department resolve the dispute. Finally, it would clarify that the Department may identify to the applicant deficiencies not identified by an inspector at the time the inspection report is provided, that the Department may independently require the applicant to submit a plan of correction or take immediate action to resolve a deficiency and that the Department may take disciplinary action if it determines that this action best serves the public interest.

 Section 1027.10 (relating to plan of correction) would provide that if the Department has determined that an EMS agency has violated a requirement imposed by the EMS System Act or a regulation promulgated under the EMS System Act, the Department may direct the EMS agency to take immediate action to correct the violation or to submit a plan of correction. It would also address the type of responses an EMS agency may make to the direction, specify the process that would follow if an EMS agency refuses to comply with the direction or otherwise challenges the determination that it has committed a violation and explain that an EMS agency's failure to comply with the direction constitutes a basis for discipline if the underlying violation of which the EMS agency is accused is substantiated following a hearing.

 Section 1027.11 (relating to conditional temporary license) would address the circumstances under which the Department may issue a conditional temporary license. Under the prior EMS act, there were two types of licenses that the Department could issue, other than a standard license, when the licensee failed to satisfy certain licensure requirements. These were a provisional license and a temporary license. Under section 8140 of the EMS System Act, the conditional temporary license replaces those types of licenses. The Department will have the discretion to issue this type of license to an EMS agency if the EMS agency cannot provide services 24 hours-a-day, 7 days-a-week or does not participate in a county or broader-level EMS response plan, approved by the Department, under which arrangements are made for it to operate less than 24 hours-a-day, 7 days-a-week. The Department would issue this type of license only when it determines it would be in the public interest to do so. A conditional temporary license would be valid for only 1 year but, unlike for the current provisional and temporary licenses, there is not a statutory limitation on the Department with respect to the number of times it may renew a license. A conditional temporary license will be subject to the terms and conditions as the Department deems appropriate. This section would provide for the Department to take disciplinary action against an EMS agency that cannot operate in compliance with the EMS System Act without a conditional temporary license, but which refuses to agree to the terms and conditions the Department attaches to its issuance of the conditional temporary license.

 Section 1027.12 (relating to discontinuation or movement of operations or reduction of service) would direct an EMS agency regarding the notices it shall provide before discontinuing an EMS service it is licensed to provide or reducing the hours it provides an EMS service. Section 8129(o) of the EMS System Act requires an EMS agency to provide 90 days advance notice to various different entities before it engages in an action. In addition to providing notice to the Department, the EMS System Act requires that an EMS agency publish notice of its intent in the EMS agency's service area and that it notify the chief executive officer of each political subdivision in its service area of its intent. This regulation would clarify that an EMS agency is permitted to discontinue a service or reduce the hours it provides the service, without providing these various notices, if ordered to do so by the Department. That could occur, for example, as a result of a disciplinary proceeding.

 Section 1027.13 (relating to management companies) would deal with the Department's approval of an entity to offer management services to an EMS agency. Under section 8129(f) of the EMS System Act, an EMS agency may enter into a contract with another entity for that entity to manage the EMS agency if that entity has been approved by the Department to manage EMS agencies. The EMS System Act does not define what managing an EMS agency entails. This section would explain that management services involve exercising operational or managerial control over an EMS agency or conducting the day-to-day operations of the EMS agency. To qualify for Department approval to manage EMS agencies, an entity needs to be a responsible person and comply with the EMS System Act and the applicable regulations. This section would either explain or reference those standards. This section would also address the application process, require a management company to update any change in the information it provided in the application for Department approval and require management companies to make certain disclosures to EMS agencies with which it contracts to provide management services. Additionally, the regulation would provide for the Department to maintain a registry of entities it has approved to offer management services to EMS agencies.

Subchapter B. EMS agency services

 This subchapter would identify the types of EMS services an EMS agency could be licensed to provide and would address specific requirements an EMS agency would need to satisfy in providing each of these services. For each type of service covered by this subchapter, the equipment and supply requirements would be listed in a notice published in the Pennsylvania Bulletin, as required under section 8129(j) of the EMS System Act.

 Section 1027.31 (relating to general standards for providing EMS) would specify eight overarching requirements for providing EMS applicable to the provision of EMS services. One of the requirements would be that when multiple EMS providers are dispatched to a scene, the first EMS provider to arrive, regardless of skill level, shall begin providing EMS to the patient. Another requirement would be that if a crew of an EMS agency service needs additional assistance in attending to the needs of a patient or patients, it is to contact a PSAP to request that assistance.

 Section 1027.32 (relating to quick response service) would explain that the purpose of a QRS is to respond to calls for EMS and provide EMS to patients before an ambulance arrives. It would clarify that a QRS may respond to a call for EMS with a single EMS provider and does not need to respond with an EMS vehicle or a vehicle. However, it would further provide that if a QRS does respond with a BLS or ALS squad vehicle, the driver of the squad vehicle would need to be an EMSVO. This section would also address certain facets of the transfer of a patient from a QRS to an ambulance service when the crew of an ambulance arrives at the scene.

 Section 1027.33 (relating to basic life support ambulance service) would explain that the purpose of an EMS agency that operates a BLS ambulance service is to operate one or more BLS ambulances staffed by a crew capable of providing all facets of EMS to a patient who requires EMS at the EMT or AEMT level. The facets of EMS include medical assessment, triage, monitoring, observation and treatment. The minimum staffing for a BLS ambulance shall be at an EMT level. However, if the EMS agency is licensed to operate a BLS ambulance at the AEMT level, the EMS agency shall staff, equip and supply a BLS ambulance at that level when it chooses or needs to operate a BLS ambulance at the level. When a BLS ambulance is so staffed, equipped and supplied, it is operating at an intermediate ALS level rather than at a BLS level. This section would specify the staffing standards at both levels. This section would clarify that although a full BLS ambulance crew is required to respond to a call for EMS, the crew members need not all respond in the ambulance, but the ambulance would need to be fully staffed when transporting a patient. This section would also address the responsibilities of a BLS ambulance crew when it is dispatched with higher level ambulance crews, such as the crew of an ALS squad vehicle, an ALS ambulance or an air ambulance. Finally, this section would authorize a BLS ambulance crew to transport from one receiving facility to another a patient who requires EMS above the skill level of that crew when the sending or receiving facility provides the personnel, equipment and supplies, not present on the ambulance, which are needed for the safe transport of the patient.

 Section 1027.34 (relating to advanced life support ambulance service) would explain that the purpose of an EMS agency that operates an ALS ambulance service is to operate one or more ALS ambulances staffed by a crew capable of providing the full array of EMS to a patient who requires EMS above the skill level of an AEMT. It would also specify the staffing standards for an ALS ambulance. Just as for a BLS ambulance, this section would explain that the crew members of an ALS ambulance need not all respond in the ambulance, but the ambulance would need to be fully staffed when transporting a patient. This section would also address the responsibilities of an ALS ambulance crew when it is dispatched with a BLS ambulance crew. It would further explain that if an ALS ambulance is used in providing EMS to a patient identified as needing EMS at or below the AEMT level, the staffing and other requirements for the ALS ambulance would be the same as for a BLS ambulance.

 Section 1027.35 (relating to advance life support squad service) would explain that the purpose of an EMS agency that operates an ALS squad service is to operate one or more ALS squad vehicles to transport an EMS provider above the skill level of an AEMT, along with equipment and supplies, to rendezvous with an ambulance crew to provide EMS to a patient who requires EMS above the skill level of an AEMT. This section would specify the staffing standards for an ALS squad vehicle. It would also address the responsibilities of an ALS squad vehicle crew when it is dispatched with a BLS ambulance crew.

 Section 1027.36 (relating to critical care transport ambulance service) would explain that the purpose of an EMS agency that operates a critical care transport ambulance service is to operate one or more ALS ambulances staffed by a crew capable of providing the full array of EMS to a patient who requires EMS at the skill level needed to attend to and transport critically ill or injured patients between receiving facilities. This section would also specify the staffing standards for an ALS ambulance when used for this purpose. While only one EMS provider would need to accompany a patient in the patient compartment of an ambulance during most ambulance transports, this section would require that two EMS providers attend to the critically ill patient during ambulance transport and would require that both EMS providers be certified above the AEMT level, with one of them having successfully completed a critical care transport educational program approved by the Department. The critically ill or injured patient requires EMS above the skill level of a paramedic. A critical care transport educational program approved by the Department would be designed by the Department to ensure that the EMS provider has completed education above the paramedic level to provide care that would normally be provided by one or more health professionals in an appropriate specialty area, such as respiratory or cardiovascular care.

 Section 1027.37 (relating to air ambulance service) would explain that the purpose of an EMS agency that operates an air ambulance service is to operate one or more air ambulances staffed by a crew capable of providing the full array of EMS to a patient. This section would also specify the staffing standards for an air ambulance. Generally, an air ambulance crew would need to include two EMS providers certified above the AEMT level, with one of them having successfully completed an air ambulance transport educational program approved by the Department. However, due to weight considerations and the occasional need for the presence of a health care provider with other health care expertise, this section would also permit another type of health care provider to substitute for one of these EMS providers provided the EMS agency submits a plan to the Department for this substitution and the plan is approved by the Department. Special requirements unique to the operation of an air ambulance would also be imposed and a process would be included for an EMS agency that operates an air ambulance service to adopt EMS protocols that supplement the Department's EMS protocols.

 Section 1027.38 (relating to special operations EMS services) would explain the purposes of a tactical EMS service, a wilderness EMS service, an urban search and rescue EMS service and a mass-gathering EMS service. It would also specify special requirements for each of them. Additionally, subsection (g) would permit an EMS agency or an applicant for an EMS agency license to apply for a type of special operations EMS service not addressed in the regulations. It would provide that the Department will consider each request on its own merits and that the Department will grant, conditionally grant or deny the request as the Department deems appropriate to protect the public interest. It would further provide that an EMS agency granted permission to operate an EMS service will be subject to later adopted regulations that may apply to that type of service. Subsection (h) would explain that an EMS agency is not required to be licensed to conduct a special operations EMS service to respond to a call requesting EMS under circumstances in which a special operations EMS service would be appropriate. However, unless licensed to conduct that special operations EMS service, it would enjoy none of the exceptions applicable to an EMS agency licensed to conduct that type of service.

 In drafting this proposed rulemaking, the Department also considered proposing the regulation of ski patrol EMS services. The Department met with and continues to meet with stakeholders, including representatives of the Pennsylvania Ski Areas Association and National Ski Patrol, concerning the appropriate oversight of EMS provided in ski areas in this Commonwealth. The Department is currently working with stakeholders to establish a voluntary program in which ski patrol EMS services may participate. The Department encourages comments on this matter.

Subchapter C. Miscellaneous

 Section 1027.51 (relating to stretcher and wheelchair vehicles) would explain that stretcher vehicles and wheelchair vehicles are vehicles that may be commercially used to transport by stretcher or wheelchair a person who does not receive and cannot reasonably be anticipated to require any EMS during transport. Under section 8129(a) of the EMS System Act, sections 8139(c) and 8156(a) of the EMS System Act (relating to stretcher and wheelchair vehicles; and penalties) and section 9 of the act of August 18, 2009 (P. L. 308, No. 37) (Act 37), when the regulations go into effect under which the Department may license EMS agencies, an entity will commit a misdemeanor of the third degree if it transports by stretcher or wheelchair vehicle a person who that entity knows or should reasonably know requires EMS during the transport. More pertinent to the Department's authority, under these same provisions, as well as section 8142 of the EMS System Act, when the regulations go into effect under which the Department may license EMS agencies, an EMS agency that impermissibly uses a stretcher vehicle will be subject to disciplinary action by the Department and an entity not licensed as an EMS agency that engages in this conduct will be subject to a civil penalty levied by the Department of up to $5,000 a day for each day it engages in the prohibited conduct.

 Section 1027.52 (relating to out-of-State providers) would identify the limited circumstances that an entity located out-of-State does not need to be licensed as an EMS agency by the Department to provide EMS in this Commonwealth.

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Chapter 1029. Medical command facilities and receiving facilities

Subchapter A. Medical command facilities

 Through medical command facilities, medical command physicians provide EMS providers with medical direction when needed. This chapter would establish the requirements for medical command facilities.

 Section 1029.1 (relating to general provisions) would address the requirements a facility needs to satisfy to secure certification as a medical command facility and the registration of that certification, which will be required at 3-year intervals. A facility would be required to submit its application for certification and the triennial registration of the certification to the regional EMS council responsible for the EMS region where the facility is located. A facility that was recognized as a medical command facility by the Department prior to the effective date of the regulation would be grandfathered and automatically certified as a medical command facility with a current registration of that certification. The initial registration of the certification of a medical command facility that was grandfathered would expire when its recognition as a medical command facility would have expired under the current regulations.

 Section 1029.2 (relating to operational requirements) would enumerate standards a medical command facility would need to meet to conduct its operations. One of the requirements would be that it needs to continue to satisfy the requirements under § 1029.1, which apply to securing certification as a medical command facility. The facilities that would be grandfathered under that section would have had to have met those requirements to have been recognized as a medical command facility under the current regulations. Under section 8127(c)(4) of the EMS System Act (relating to medical command facilities), a medical command facility is required to take measures necessary to ensure that a medical command physician is available to provide medical command at all times. Two requirements that would be included in this section to ensure this would be met are that the facility would need to have a contingency agreement with at least one other medical command facility to assure availability of medical command and it will need to notify PSAPs through which it routinely receives requests whenever it would not have a medical command physician available. A significant change from the current requirements is that while now a medical command facility is required to keep a record of medical command communications for 180 days, it would be required to keep a recording or other documentation of medical command communications for 7 years. Documentation of the session other than through a recording would be acceptable if medical command is provided at the patient site rather from the location of the medical command facility.

 Section 1029.3 (relating to processing certification and registration applications) would address how regional EMS councils and the Department would process an application for medical command facility certification and the triennial registration of the certification. If after conducting an inspection of the applicant a regional EMS council would determine that the medical command facility or the applicant for medical command facility certification has not satisfied regulatory requirements, the medical command facility or the applicant would be given an opportunity to file a written rebuttal with the Department and the Department would resolve the dispute.

 Section 1029.4 (relating to inspections and investigations) would explain that the Department or a regional EMS council would inspect a medical command facility at least once every 3 years and would conduct other investigations as the need arises. It would further require a medical command facility or an applicant for medical command facility certification to fully respond to any inquiry by the Department or a regional EMS council regarding its compliance with the regulations and to provide them with full and free access to examine the facility and its records relating to its operation as a medical command facility.

 Section 1029.5 (relating to plan of correction) would provide the Department with the option of requesting a medical command facility to submit a plan of correction to resolve its regulatory violations instead of the Department pursuing disciplinary action against the facility for its infractions. Depending upon the nature of a violation, the Department could also demand that the facility immediately remedy the problem. The facility would have the option of complying with the Department directive, not complying or complying while challenging the violation. If the facility would challenge the violation, the Department would evaluate the rebuttal and rescind the notice of violation if it agrees with the facility. If the facility refuses to comply with the Department directive and the Department pursues disciplinary action, the failure to comply would be another ground for discipline if the underlying violation is proven following a hearing.

 Section 1029.6 (relating to discontinuation of service) would require, as does the current regulation, that a medical command facility provide 90 days advance written notice to the Department, relevant regional EMS councils and the EMS agencies for which it routinely provides medical command that it is discontinuing medical command services. It would also require the medical command facility to advertise its discontinuation of service in a newspaper of general circulation in its service area at least 90 days in advance of discontinuing service.

Subchapter B. Receiving facilities

 A receiving facility is a facility to which an ambulance transports a patient who requires prompt medical attention in addition to that provided to the patient by EMS providers in the field. Section 1029.21 (relating to receiving facilities) would specify the requirements that a facility would need to satisfy to be recognized by the Department as a receiving facility. This section would require EMS agencies to transport patients to a receiving facility as directed in the Statewide EMS protocols unless directed otherwise by a medical command physician or the Statewide protocols. Some patients, such as those with serious burns or trauma, would benefit if they were transported to a specialty receiving facility, which is a receiving facility with EMS resources in excess of those generally required for a receiving facility, geared to treat patients who require specialized care. This section would require that an EMS agency transport these patients with special needs to a specialty receiving facility if so directed by the Statewide EMS protocols and not otherwise directed by a medical command physician. Sometimes transport to a receiving facility would not be practical because of the patient's overall condition and the time it would take to transport the patient to a receiving facility. The Department would maintain a list of specialized receiving facilities which it would publish and update through notices in the Pennsylvania Bulletin. Finally, this section would require a receiving facility to acknowledge receipt of the patient in writing to the ambulance crew that transported the patient to the receiving facility if that acknowledgement is requested.

Chapter 1031. Complaints, disciplinary actions, adjudications and appeals

 Under the EMS System Act, the Department has far more disciplinary authority than it had under the prior EMS act. Under the EMS System Act, the Department has disciplinary authority over EMS providers, EMVOs, EMS agencies, medical command physicians, medical command facility medical directors, medical command facilities, certified EMS instructors, EMS educational institutes, sponsors of continuing education and management companies. It also has authority to impose civil money penalties against entities that conduct EMS operations without being licensed as an EMS agency, individuals who provide EMS without being certified as an EMS provider or having other legal authority to engage in this conduct and vendors of EMS PCR software who engage in certain proscribed conduct. This chapter would address the Department's authority over each of these entities. Often, misconduct by entities regulated by the Department is brought to the Department's attention by persons who file complaints with the Department. This chapter would also guide persons through the complaint process. Additionally, this chapter would set forth a few administrative rules applicable to disciplinary proceedings that would supplement or supersede rules in 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedures) (GRAPP).

 Section 1031.1 (relating to administrative and appellate procedure) would specify the statutory and regulatory rules under which administrative proceedings conducted under the EMS System Act would be conducted. In general, administrative proceedings would be conducted under GRAPP. However, subsection (b) would set forth rules that would supplement GRAPP. These rules would address how disciplinary proceedings under the EMS System Act would be initiated, the duty of the parties to a proceeding to plead matters they intend to raise, standards for requesting a continuance of a hearing and requesting an interpreter when needed. It would also explain that adjudications of the Department issued under the EMS System Act and Chapter 1031 may be appealed to the Commonwealth Court.

 Section 1031.2 (relating to complaints and investigations) would inform persons who have reason to complain to the Department about the conduct of persons the Department regulates under the EMS System Act, as well as unauthorized practices by persons not licensed or certified under the EMS System Act, about how the complaint and investigation procedures are designed to work. It would apprise persons where they are to file complaints and that the Department's Bureau of Emergency Medical Services (Bureau) will handle complaints on behalf of the people of this Commonwealth to determine whether there has been a violation of the statute or the regulations adopted thereunder. It would also give persons some basic information regarding how their complaints would be handled, as well as inform them about what information they would receive regarding the disposition of a complaint and when they would receive that information.

 Section 1031.3 (relating to discipline of EMS providers) would set forth grounds for the Bureau to take disciplinary or corrective action against EMS providers and the types of discipline and corrective sanctions that the Department could impose upon an EMS provider if grounds exist for imposing those sanctions. It would also include a subsection addressing the procedures to be followed if there are grounds for denying the biennial or triennial registration of an EMS provider's certification. If there are grounds for taking action, a new registration would be issued to the EMS provider, if the EMS provider qualifies for it, unless those grounds would justify an automatic or emergency suspension of the certification. An order to show cause would be issued and disciplinary action would be taken against the EMS provider's certification. However, if an EMS provider would not qualify for renewal of the provider's registration because the EMS provider did not secure the continuing education or pass the registration examinations required to renew the registration, a new registration would not be issued. If the EMS provider would challenge the Bureau's determination that these requirements were not satisfied and the Bureau rejected the challenge, the Bureau would issue an order to show cause and it would be the EMS provider's burden to demonstrate satisfaction of the registration requirements. The provision in this section specifying grounds for discipline, like the other sections in this chapter pertaining to the discipline of individuals and entities that hold a certification, license or accreditation issued under the EMS System Act, would also apply to applicants for those certifications, licenses and accreditations, and would present grounds for denying or imposing conditions upon such certifications, licenses and accreditations.

 Section 1031.4 (relating to reinstatement of revoked EMS provider certification) would permit an individual whose EMS provider certification has been revoked to apply for reinstatement of the certification after 5 years have elapsed. It would explain the process to apply for reinstatement and the criteria the Department would use to act upon an application for reinstatement. It would further provide that if the Department denies the application, the individual would need to wait for at least a year from the date of the denial before again applying for reinstatement of the certification. This section would repeat the reinstatement requirements in section 8121(d) of the EMS System Act (relating to certification sanctions).

 Section 1031.5 (relating to discipline of EMS vehicle operators) would set forth grounds for the Bureau to take disciplinary or corrective action against EMSVOs and identify the types of discipline and corrective sanctions that could be imposed against them. It would also include a subsection dealing with the automatic suspension of an EMSVO's certification for 4 years if the EMSVO is convicted of a criminal offense that involves driving under the influence of alcohol or drugs and for 2 years if the EMSVO is convicted of a criminal offense that involves reckless driving. These automatic suspensions are required under section 8122(f) of the EMS System Act.

 Section 1031.6 (relating to emergency suspension of EMS provider and EMS vehicle operator certifications) would provide, as authorized under section 8123(a) of the EMS System Act (relating to suspension of certification), for the emergency suspension of an EMS provider or EMSVO certification if the individual is a clear and immediate danger to the public health and safety. For an emergency suspension to be imposed, the Department would need to be presented with credible evidence of this danger. This section would provide that the Bureau would give the individual a written statement of the factual allegations supporting the action, and that a hearing would be conducted within 30 days to determine if there is prima facie evidence to support the emergency suspension, unless the hearing would be continued at the request of the individual. The section would further provide that the suspension will continue for 180 days if a prima facie case for the emergency suspension is made. That suspension would expire after 180 days unless the Bureau takes action against the individual through the normal disciplinary process and an adjudication is issued, providing otherwise, before 180 days elapse. A provision would be included to allow the emergency suspension to exceed 180 days if agreed upon by the parties. This would most likely occur when the individual whose certification was suspended seeks additional time to prepare for the full disciplinary hearing.

 Section 1031.7 (relating to discipline of EMS instructors) would set forth grounds for taking disciplinary or corrective action against EMS instructors who are certified by the Department and the types of discipline and corrective sanctions that could be imposed upon an EMS instructor if sanctions are warranted. As explained in § 1025.1(f), not all instructors in EMS training institutes need to be certified as EMS instructors by the Department. This section would apply only to those instructors who are certified by the Department.

 Section 1031.8 (relating to discipline of medical command physicians and medical command facility medical directors) would set forth grounds for the Bureau to take disciplinary or corrective action against medical command physicians and medical command facility medical directors and identify the types of discipline and corrective sanctions that could be imposed against them.

 Section 8123(b) of the EMS System Act provides for the automatic suspension of the certification issued under the statute to an individual if that individual is adjudicated to be incapacitated under 20 Pa.C.S. § 5511 (relating to petition and hearing; independent evaluation) or an equivalent statutory provision. It further provides for the lifting of that suspension if that individual has been adjudicated to have regained capacity. Section 1031.9 (relating to automatic suspension for incapacity) would essentially repeat the provisions of the statutory section.

 Section 1031.10 (relating to discipline of EMS agencies) would set forth grounds for the Bureau to take disciplinary action against EMS agencies and identify the types of discipline and corrective sanctions that could be imposed against them.

 Section 1031.11 (relating to discipline of medical command facilities) would set forth grounds for the Bureau to take disciplinary action against medical command facilities and identify the types of discipline and corrective sanctions that could be imposed against them.

 Section 1031.12 and § 1031.13 (relating to discipline of providers of EMS continuing education) would set forth grounds for the Bureau to take disciplinary action against EMS educational institutes and providers of EMS continuing education and specify the types of disciplinary sanctions the Department could impose upon them.

 Section 1031.14 (relating to civil money penalty for practicing without a license or certification) would provide for the Department to impose civil money penalties against entities that operate an EMS agency without a license and individuals who provide EMS without a certification. To operate as an EMS agency, an entity would not need to hold itself out as an EMS agency—it would merely need to engage in an activity for which an EMS agency license is required. For example, a business that would not be licensed as an EMS agency could own and operate stretcher or wheelchair vehicles and legally transport by stretcher or wheelchair persons who during transport do not require and are not reasonably expected to require EMS. However, if an entity would transport by stretcher or wheelchair an individual that it knows or should reasonably know requires EMS during transport, that entity would be operating an EMS agency without a license. Under this section, the Department could impose upon it a civil money penalty of $5,000 per day for each day that it engages in the activity.

 Section 1031.15 (relating to discipline of vendors of EMS PCR software) would provide for the Department to impose civil money penalties against vendors of EMS PCR forms and software who violate § 1021.43(b) and (d). These subsections enumerate the statutory basis for imposing penalties under section 8106(f) of the EMS System Act. This provision authorizes the Department to assess a vendor of EMS PCRs a civil money penalty of up to $5,000 a day for each day it offers reporting forms or software marketed as appropriate for submitting EMS PCRs if they have not been reviewed and approved by the Department. The software vendor would likewise need to secure Department approval of a substantive modification of the product for use as an EMS PCR to avoid the possibility of the civil money penalty. Moreover, if the Department makes changes to the EMS PCR form, a vendor would not be able to market the form or software for EMS PCR use unless it modifies the product and secures Department approval of the modified product.

 Section 1031.16 (relating to discipline of management companies) would set forth standards for the Department to deny, withdraw or condition the approval of an entity to offer management services to EMS agencies.

Chapter 1033—Special event EMS

 This chapter would reinstate, with some changes, the current chapter dealing with the Department review of plans to provide EMS and coordinate EMS resources with other resources to promote emergency preparedness at special events. It would enable entities to secure assistance in planning for medical emergencies when they are responsible for the management and administration of a planned activity that places a large volume of attendees and participants in a defined geographic area where access to EMS might otherwise be delayed due to a variety of factors, such as the volume of attendees, scarce EMS resources and traffic congestion. The Department may have the authority, under its power under section 8105(b)(11) of the EMS System Act, to mandate entities to submit special event EMS plans to the Department for its review and approval. Nevertheless, the Department proposes to retain the voluntary character of its current special event EMS plan approval process. As the lead agency for EMS in this Commonwealth, the Department believes that this is a public service that the Department should make available to entities desiring its assistance.

 Section 1033.1 (relating to special event EMS planning requirements) would require that the entity responsible for the management and administration of a special event submit its proposed special event EMS plan to the Department through the regional EMS council assigned responsibility for the EMS region in which the special event would be held. The plan could cover a single event or a series of events in a calendar year. The entity would need to submit a new special event EMS plan if it wants to secure Department approval of a plan for special events it will conduct in the next calendar year. This section would also specify the information the Department requires to be included in a special event EMS plan to obtain the Department's review and provide that the plan would need to satisfy the requirements of the chapter to secure Department approval.

 Section 1033.2 (relating to administration, management and medical direction requirements) would require that a special event EMS plan identify a special event EMS director and a special event EMS medical director. It would also specify the qualifications and responsibilities of these officials.

 Section 1033.3 (relating to special event EMS personnel and capability requirements) would require that EMS providers be certified at appropriate levels based upon the level of EMS approved by the Department in the special event EMS plan. It would also require a number of ambulances to be stationed at the special event that would be based upon the number of persons expected to be present at any one time.

 Section 1033.4 (relating to onsite facility requirements) would specify onsite facilities that would need to be present if the persons expected to be present at the special event at any one time exceed 25,000.

 Section 1033.5 (relating to communications system requirements) would describe the communications capabilities that would be required of a special event EMS plan.

 Section 1033.6 (relating to requirements for educating event attendees regarding access to EMS) would require that the entity responsible for managing and administering the special event demonstrate a plan for educating persons in attendance of the presence and location of EMS and the process for obtaining EMS if needed and for alerting those persons of specific hazards, serious changing conditions and evacuation procedures.

 Section 1033.7 (relating to special event report) would require an entity that secured Department approval of a special event EMS plan to file a special event report with the Department, through the relevant regional EMS council, on a special event report form prepared by the Department within 30 days following the last day of the special event.

Fiscal Impact

Regulated community

 There could be additional cost to some EMS agencies if they have to operate around the clock, but this is imposed by the EMS System Act, not the regulations. Currently, there is not a requirement for BLS ambulance services and QRSs to meet this standard. The EMS System Act requires that an EMS agency provide service around the clock, but also makes provisions for exceptions. Both the general requirement and the exceptions are captured in this proposed rulemaking. The exceptions include operating under an area wide plan accepted by the Department or operating under a conditional temporary license. In both instances, permission to operate less than 24 hours-a-day, 7 days-a-week would be based upon the Department determining that the permission advances the public interest. It is not possible to calculate the costs that would be incurred by those operations that are operating less than on a full-time basis that will be required to operate on a full-time basis.

 There will also be additional costs to EMS agencies for EMS operations that do not now have a medical director. Once again, this additional cost is imposed by the EMS System Act, not the regulations, and it is impossible to estimate the costs. Currently, ALS operations and about 80% of the BLS operations meet this requirement. Some medical directors serve as volunteers and others are paid a significant sum. Plans are for the regional EMS councils, the Pennsylvania Medical Society, the Pennsylvania Chapter of the American College of Emergency Physicians and the Department to work together to assist EMS agencies in meeting this requirement.

Local government

 There would not be appreciable additional costs or savings to local government since the changes do not affect local government per se. Some of the regional EMS councils are a part of county government. However, they would be performing essentially the same work under the EMS System Act and the proposed regulations as they are currently performing.

State government

 There will be an increase in costs to the Department associated with its duty to license and certify EMS providers and other persons and entities involved in the EMS system. A duty to certify these persons did not previously exist. These additional costs will be imposed by the EMS System Act, not the regulations. The costs that will be incurred associated with issuing certification and registrations for EMSVOs, EMRs, AEMTs, PHPEs, medical command physicians and medical command facility medical directors. This will also require the development of additional patches and decals to recognize the new levels of certification with an estimated cost of $1,500 per new type of EMS provider certification.

 There will be a need for enhancement to the EMS Registry System software and Agency Application System software with an estimated total cost of $87,590 the first year attributable to adding an additional staff position in the Department's Bureau of Information Technology. Both enhancements will include required improvements to the EMS Registry System and Agency Application System to meet National standards for EMS credentialing. Application is being made for a Federal grant to fund this project.

 The Department's disciplinary authority has been expanded under the EMS System Act and the ability to impose civil money penalties has been added. This is repeated in the proposed regulations. Depending upon the type of entity against which action is taken, fines can be up to $1,000 to $5,000 per finable violation. These violations and civil money penalties should generate at least $10,000 per year to return to the EMS Operating Fund.

 Additional State saving will be realized in the contract/grant award process by the Department not being required to devote staff time to triennially justify sole source contracting with the regional EMS councils. Section 8112(l) of the EMS System Act provides that the Department may renew a contract or grant with a regional EMS council without engaging in competitive bidding if in performing its duties under the prior grant/contract the regional EMS council demonstrated its ability and commitment to the Department's satisfaction to meets its responsibilities under that grant/contract. This cost-savings measure is repeated in the proposed regulations.

 Various provisions of the EMS System Act require an applicant for EMS provider or EMSVO certification to report to the Department misdemeanor, felony and other criminal convictions that are not summary or equivalent offenses and disciplinary sanctions that have been imposed upon a license, certification or other authorization of the applicant to practice an occupation or profession. An applicant for an EMSVO certification is to report to the Department any other conviction of an offense involving reckless driving or driving under the influence of alcohol or drugs. The proposed regulations will require the applicant to also arrange for the custodian of the criminal charging, judgment and sentencing document for each conviction and the custodian of adjudication or other document imposing discipline against the applicant to provide the Department with a certified copy of those records. This will save the Department the cost and time to request and receive the required documents to review in deciding whether to grant, deny or impose conditions on a certification.

 The EMS System Act, as well as the proposed regulations, will require the medical director of an EMS agency to conduct an initial and annual assessment of each EMS provider of the EMS agency at or above the advance EMT level and to determine whether to allow the EMS provider to provide skills at the level at which the provider is certified. Once this assessment is completed, there is not an appeal process of the EMS agency medical director's decision. Under the current law, the credentialing determination is called a medical command authorization decision and a decision adverse to the provider's interest can be appealed to the regional EMS medical director and that decision can be appealed to the Department, which decision in turn can be appealed to the Commonwealth Court. This appeal process imposes costs on the affected EMS provider, the medical director who made the decision, the regional EMS council and the Department. The EMS System Act eliminates the appeal process and the associated costs. The proposed regulations will carry this through.

Paperwork Requirements

 There are a few paperwork requirements that are proposed that are not imposed by the prior EMS act and the regulations adopted thereunder. The proposed regulations foster electronic transmissions. There would, however, be a few changes regarding required paperwork.

 Section 1021.41(c) states that when an EMS agency transports a patient to a receiving facility, before its ambulance departs from the receiving facility, the EMS agency having primary responsibility for the patient shall verbally, and in writing or by other means by which information is recorded, report to the individual at the receiving facility the patient information that is essential for immediate transmission for patient care. It further states that the Department will publish a notice in the Pennsylvania Bulletin specifying the types of patient information that are essential for patient care. This patient transfer document would be new. It has already been developed and employed in a pilot project to address the smooth transfer of a patient to a high level of care and to ensure that the prehospital care and other essential patient information is documented.

 The current regulations require that a completed EMS PCR be submitted to the hospital within 24 hours. With the development of the patient transfer document, the prompt need for a full patient care record will be less. Therefore, the proposed regulations would allow the EMS provider to submit the completed EMS PCR to the receiving facility to which the patient was transported within 72 hours after the EMS agency concluded patient care, instead of the now required 24 hours. This will be a cost savings to EMS agencies since currently some ambulance services have to pay staff overtime to complete the full EMS PCR and meet current State standards.

 Under the EMS System Act, the Department will be licensing for the first time special operations EMS services such as tactical EMS services and mass gathering EMS services. When an EMS agency provides EMS through one of these special operations, its paperwork responsibilities would be somewhat different than the norm. Under § 1027.38, it would need to maintain a log of every patient encounter, but would only be required to complete an EMS PCR for a patient transported by ambulance from the special operations EMS incident who receives EMS exceeding the scope of practice of an EMT. It would also need to complete an EMS PCR for a patient not transported by an ambulance that refuses EMS or dies while under the care of the special operations EMS service. For a patient transported by ambulance, the special operations would need to complete the less extensive written transfer of care form referenced in § 1021.41(c) through which essential patient information is provided.

Effective Date/Sunset Date

 Several of the proposed regulations will go into effect when published in the Pennsylvania Bulletin as final-form regulations. Others, as well as the statutory provisions to which they relate, will not go into effect until 180 days after the final-form regulations are published. Under section 9(1) of Act 37, sections 8113(a), (c), (d) and (n), 8114—8120, 8122, 8129—8138 and 8140—8142 of the EMS System Act will not go into effect until 180 days after the final-form regulations are published. Several sections of this proposed rulemaking will not become effective until 180 days after the final-form regulations are published. Additionally, the Department will include among its orders adopting the final-form rulemaking an order directing that the effective date of these regulations will be 180 days after the final-form regulations are published. The Department has coordinated with the Legislative Reference Bureau to ensure that that date will be determined by the Legislative Reference Bureau. A source note under each regulation in the Pennsylvania Code will state the effective date.

 A sunset date will not be imposed. The Department will monitor the regulations to ensure that they meet EMS needs that are within the scope of its authority to address through regulations.

Statutory Authority

 There are several provisions in the EMS System Act that expressly confer upon the Department the duty or discretion to adopt regulations. However, section 7 of Act 37 provides that Act 37 shall be liberally construed to authorize the Department to promulgate regulations to carry out the provisions of the EMS System Act and that the absence of express authority to adopt regulations in a provision of the EMS System Act may not be construed to preclude the Department from adopting a regulation to carry out that provision.

 Section 8103 of the EMS System Act defines a few terms in a manner that expressly permit the Department to expand the definition by regulation. The term ''EMS agency—emergency medical services agency'' is defined as an entity that may provide EMS through the operation of certain types of services and the deployment of certain vehicles, which are listed in the definition. The definition also provides that the Department may expand the list of services and vehicles through regulation. The definition of ''EMS provider—emergency medical services provider'' identifies the different types of EMS providers certified by the Department. It also empowers the Department to establish by regulation other types of EMS providers to provide specialized EMS. This is also addressed in section 8113(a) of the EMS System Act.

 Section 8105 of the EMS System Act includes several provisions that provide for the Department to carry out responsibilities by adopting regulations. Section 8105(b)(2) of the EMS System Act authorizes the Department to establish by regulation standards and criteria governing the awarding and administration of contracts and grants by the Department for the initiation, maintenance and improvement of regional EMS systems. Section 8105(b)(4) of the EMS System Act empowers the Department to collect, under Department regulations, information about patients admitted to various facilities. Section 8105(b)(11) of the EMS System Act authorizes the Department to promulgate regulations to establish standards and criteria for EMS systems. On the other hand, section 8105(c) of the EMS System Act, which addresses the Department establishing EMS protocols for the evaluation, triage, transport, transfer and referral of patients, states that those protocols are not subject to the rulemaking process. Further, section 8109(b)(8) of the EMS System Act, which speaks to regional EMS councils establishing protocols, subject to Department approval, to supplement the Department's EMS protocols, also provides that those protocols are not subject to the rulemaking process.

 Section 8106 of the EMS System Act provides that an EMS agency shall report to the Department or a regional EMS council, as directed by Department regulation, information from EMS PCRs solicited through the reporting process.

 Section 8108 of the EMS System Act (relating to State Advisory Board) provides that one of the duties of the Board is to advise the Department regarding the content of its regulations.

 Section 8113(d)(1) and (2) of the EMS System Act requires the Department to develop standards through regulations for the accreditation and reaccreditation of EMS educational institutes and for the approval of continuing education courses and the accreditation of entities that provide continuing education courses. Section 8113(e) of the EMS System Act establishes standards for taking and passing EMS provider certification examinations. Nevertheless, section 8113(e)(7) of the EMS System Act permits the Department to change those standards through regulations. Section 8113(c) of the EMS System Act provides that applicants for EMS provider certification are to submit their application through a form or an electronic process as prescribed by the Department by regulation.

 Sections 8114—8120 of the EMS System Act pertain to the certification and registration requirements for the various types of EMS providers and the scope of their practice. The scope of practice subsections specify the capacities in which the EMS providers may function. Each of these subsections makes provision for the EMS provider to function in additional capacities as authorized by the Department regulation. To practice as an EMS provider an EMS provider requires not only a certification, but current registration of that certification. These sections provide that the application for registration of an EMS provider certification is to be submitted through a form or an electronic process as prescribed by the Department by regulation. They also provide that when the registration has expired and the EMS provider subsequently seeks to register the certification, the EMS provider may secure a current registration of the provider's certification by qualifying for the registration under requirements established by the Department by regulation. To ensure that there is not an unintentional lapse in the registration of an EMS provider certification, the sections also provide that the registration applications are to be submitted at least 30 days prior to when they are to expire. However, the sections also provide for the applications to be submitted within a lesser time before their expiration if permitted by Department regulation.

 The provisions in section 8122(a)(1) and (b)(1) of the EMS System Act are similar to those in sections 8113—8120 of the EMS System Act regarding the use of regulations to prescribe the manner in which applications for EMSVO certification and registration of the certification are to be submitted, as well as the use of regulations to prescribe requirements for registering a certification after the registration has expired.

 The provisions in section 8124(a)(1) and (b)(1)(i) and (2) of the EMS System Act (relating to emergency medical services instructors) are similar to section 8122(a)(1), (b)(1) and (4) and (c) of the EMS System Act. These provisions apply to persons who seek to become and then become certified EMS instructors (not all EMS instructors need to be certified). Subsection (c) provides that the Department may adopt regulations to set standards for EMS instructors in providing instruction in EMS educational institutes.

 Section 8125(b) of the EMS System Act prescribes the roles and responsibilities of an EMS agency medical director. Section 8125(b)(9) of the EMS System Act provides that the EMS agency medical director is to perform other functions as imposed by the Department by regulation.

 The provisions in section 8126(b)(1), (c)(1), (f)(1) and (g)(1) of the EMS System Act (relating to medical command physicians and facility medical directors) are similar to those previously referenced that provide for applications for certification and registration of the certification to be submitted through a form or an electronic process as prescribed by the Department. The certifications and registrations are for medical command physicians and medical command facility medical directors. These provisions, unlike prior similar provisions, do not expressly state that the Department is to employ regulations to prescribe the processes.

 Section 8127(b) and (e) of the EMS System Act provides for medical command facility certifications and registration of those certifications to be submitted through a form or an electronic process as prescribed by the Department. As in the preceding section, these subsections do not expressly state that the Department is to employ regulations to prescribe the processes. Subsection (c) imposes certification and operational requirements on medical command facilities. Subsection (d) provides that the Department may employ regulations to impose additional requirements on medical command facilities.

 Section 8128(b) of the EMS System Act (relating to receiving facilities) specifies requirements that a facility needs to satisfy to qualify to receive patients transported by ambulance. However, it also includes a provision that empowers the Department, through regulations, to authorize special facilities to receive patients transported by ambulance who have special medical needs.

 Section 8129 of the EMS System Act includes more provisions that expressly direct or authorize the Department to promulgate regulations than any other section of the EMS System Act. Subsections (b) and (e) provide for EMS agency certifications and registration of those certifications to be submitted through a form or an electronic process as prescribed by the Department. They do not expressly state that the Department is to employ regulations to prescribe these processes. Subsection (a) provides that an entity may not operate as an EMS agency unless it holds an EMS agency license. It specifies various vehicles and services, the operation of which constitutes operating as an EMS agency, but also authorizes the Department to specify by regulation other vehicles and services the operation of which will constitute acting as an EMS agency. Under section 8129(c)(6) of the EMS System Act, an applicant for an EMS agency license shall be in compliance with the regulations adopted under the EMS System Act.

 Section 8125(a) of the EMS System Act prescribes in general terms the requirements a physician shall serve as an EMS agency medical director.

 Section 8129(c)(5) of the EMS System Act provides that the Department may, by regulation, establish other criteria an applicant for an EMS agency license shall demonstrate that its EMS agency medical director satisfies based upon the types of EMS vehicles the applicant is applying to operate and the types of services it is applying to provide.

 Section 8129(f)(1) of the EMS System Act permits an EMS agency to enter into a contract with another entity to manage the EMS agency, but provides that an entity that provides management services for an EMS agency shall be approved by the Department. One of the requirements for approval is that the entity be in compliance with the Department's regulations.

 Section 8129(g) of the EMS System Act provides for specified types of EMS vehicles to display a Department-issued inspection sticker as prescribed by the Department by regulation and further provides that the Department, by regulation, may require other types of EMS vehicles to display a Department-issued inspection sticker.

 Section 8129(i)(2) of the EMS System Act provides that if an EMS agency operates a communications center that dispatches EMS resources, the activity shall be viewed as part of the EMS agency's licensed operation and subject to the Department's regulations.

 Sections 8130—8137 of the EMS System Act deal with various types of vehicles EMS agencies operate and services they provide. Each of these sections includes a subsection that addresses staffing requirements. Section8129(l) of the EMS System Act provides that the Department may by regulation revise some of those staffing standards.

 Section 8129(p) of the EMS System Act is the most encompassing subsection of the section addressing rulemaking. It provides that the Department will promulgate regulations setting forth requirements for EMS agencies in this Commonwealth based upon the types of EMS vehicles they operate and the services they provide.

 Section 8136 of the EMS System Act (relating to special operations emergency medical services) pertains to types of EMS services that operate in situations or austere environments that require specialized knowledge, equipment or vehicles to access a patient or address a patient's emergency medical needs. Section 8136(a) of the EMS System Act provides that the Department will provide by regulation for specific types of special operations teams. Section 8136(b) of the EMS System Act permits the Department, by regulation, to prescribe additional training and expertise requirements for the EMS agency medical director and the EMS providers who staff a special operations EMS service. Section 8136(c) of the EMS System Act authorizes the Department to employ regulations to establish staffing, equipment, supply and other requirements of these services. Section 8136(d) of the EMS System Act deals with applications to provide special operations EMS services that the Department has not addressed in regulations. It provides that the Department will evaluate the merits of each application on an individual basis and may conditionally deny or grant an application based upon considerations of public health and safety. If further provides that the grant of an application will be subject to compliance with any later-adopted regulations addressing that type of special operations EMS service.

 Section 8138 of the EMS System Act (relating to other vehicles and services) authorizes the Department to promulgate regulations to establish EMS vehicle and service standards for EMS vehicles and services not specified in the EMS System Act.

Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on October 11, 2011, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Committee on Public Health and Welfare and the House Committee on Veterans Affairs and Emergency Preparedness. A copy of this material is available to the public upon request.

 Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.

Contact Person

 Persons interested in providing comments, suggestions or objections regarding the proposed rulemaking should submit them to Joseph W. Schmider, Director, Bureau of Emergency Medical Services, Department of Health, Room 606 Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120-0701 within 30 days after publication of this proposed rulemaking in the Pennsylvania Bulletin. Persons with a disability who require an alternative format of this proposed rulemaking (for example, large print, audiotape or Braille) should contact Joseph W. Schmider at the previously listed address or at [phone] to make the necessary arrangements. Speech or hearing impaired persons may use VTT [phone] or the Pennsylvania AT&T Relay Service at [phone] (TT). Persons with a disability may submit their comments, suggestions or objections regarding the proposed rulemaking in alternative formats previously listed.

ELI N. AVILA, MD, JD, MPH, FCLM, 
Secretary

 Fiscal Note: 10-190. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 28. HEALTH AND SAFETY

PART VII. EMERGENCY MEDICAL SERVICES

Subpart A. EMS SYSTEMS

CHAPTER 1001. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1001, which appears in 28 Pa. Code pages 1001-1—1001-29, serial pages (336959), (336960), (297023), (297024), (269307)—(269312), (302695)—(302698), (293995), (293996), (269317)—(269322), (302699)—(302702) and (269327)—(269333).)

Sec.
1001.1—1001.7.	(Reserved).
1001.21—1001.28.	(Reserved).
1001.41.	(Reserved).
1001.42.	(Reserved).
1001.61.	(Reserved).
1001.62.	(Reserved).
1001.65.	(Reserved).
1001.81—1001.84.	(Reserved).
1001.101.	(Reserved).
1001.121—1001.125.	(Reserved).
1001.141—1001.143.	(Reserved).
1001.161.	(Reserved).

CHAPTER 1003. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1003, which appears in 28 Pa. Code pages 1003-1—1003-35, serial pages (282207), (282208), (269337)—(269354), (293997), (293998), (302703), (302704) and (269359)—(269369).)

Sec.
1003.1—1003.5.	(Reserved).
1003.21—1003.23.	(Reserved).
1003.23a.	(Reserved).
1003.24.	(Reserved).
1003.25a.	(Reserved).
1003.25b.	(Reserved).
1003.26—1003.34.	(Reserved).

CHAPTER 1005. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1005, which appears in 28 Pa. Code pages 1005-1—1005-19, serial pages (269371), (269372), (294001), (294002), (302705), (302706), (269377)—(269380), (287207), (287208), (302707)—(302710) and (269387)—(269389).)

Sec.
1005.1.	(Reserved).
1005.2.	(Reserved).
1005.2a.	(Reserved).
1005.3—1005.7.	(Reserved).
1005.7a.	(Reserved).
1005.8—1005.15.	(Reserved).

CHAPTER 1007. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1007, which appears in 28 Pa. Code pages 1007-1—1007-10, serial pages (269391)—(269396), (302711), (302712), (294009) and (294010).)

Sec.

1007.1.	(Reserved).
1007.2.	(Reserved).
1007.7.	(Reserved).
1007.8.	(Reserved).

CHAPTER 1009. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1009, which appears in 28 Pa. Code pages 1009-1—1009-5, serial pages (269401)—(269405).)

Sec.
1009.1.	(Reserved).
1009.2.	(Reserved).
1009.4—1009.6.	(Reserved).

CHAPTER 1011. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1011, which appears in 28 Pa. Code pages 1011-1—1011-7, serial pages (269407)—(269413).)

Sec.

1011.1.	(Reserved).
1011.3.	(Reserved).
1011.4.	(Reserved).

CHAPTER 1013. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1013, which appears in 28 Pa. Code pages 1013-1—1013-5, serial pages (269415)—(269419).)

Sec.
1013.1—1013.8.	(Reserved).

CHAPTER 1015. (Reserved)

 (Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1015, which appears in 28 Pa. Code pages 1015-1—1015-3, serial pages (269421), (269422) and (294011).

Sec.

1015.1.	(Reserved).
1015.2.	(Reserved).

CHAPTER 1021. ADMINISTRATION OF THE EMS SYSTEM

Subchap.

A.	GENERAL PROVISIONS
B.	AWARD AND ADMINISTRATION OF EMSOF FUNDING
C.	COLLECTION OF DATA AND INFORMATION
D.	QUALITY IMPROVEMENT AND PEER REVIEW
E.	TRAUMA CENTERS
F.	REGIONAL EMS COUNCILS
G.	ADVISORY BOARD
H.	EMS RESEARCH

Subchapter A. GENERAL PROVISIONS

Sec.

1021.1.	Purpose.
1021.2.	Definitions.
1021.3.	Applicability.
1021.4.	Exceptions.
1021.5.	Investigations.
1021.6.	Comprehensive EMS system plan.
1021.7.	Comprehensive regional EMS system plan.
1021.8.	EMS data collection.

§ 1021.1. Purpose.

 The purpose of this subpart is to facilitate improvement of the Statewide EMS system into a comprehensive and flexible system through coordination of the regional EMS systems, to synchronize the Statewide and regional systems with EMS systems in neighboring states and to otherwise implement the Department's responsibilities under the act consistent with the Department's rulemaking authority.

§ 1021.2. Definitions.

 The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:

 ACLS course—Advanced cardiac life support course—A course in advanced cardiac life support sanctioned by the American Heart Association.

 AEMT—Advanced emergency medical technician—An individual who is certified by the Department as an advanced EMT.

 ALS—Advanced life support.

 ALS ambulance—Advanced life support ambulance—An ambulance that is staffed and equipped to provide EMS above the AEMT level and used in the transport of patients.

 ALS squad vehicle—Advanced life support squad vehicle—

 (i) A vehicle that is maintained or operated to transport EMS providers above the AEMT level, and equipment and supplies, to rendezvous with the crew of an ambulance for the purpose of providing advanced EMS to patients.

 (ii) The vehicle is not used in the transport of patients.

 APLS course—Advanced pediatric life support course—A course in advanced pediatric life support sanctioned by the American Academy of Pediatrics and the American College of Emergency Physicians.

 ATLS course—Advanced trauma life support course—A course in advanced trauma life support sanctioned by the American College of Surgeons Committee on Trauma.

 Act—35 Pa.C.S. §§ 8101—8157 (relating to Emergency Medical Services System Act).

 Advanced EMS—Advanced emergency medical services—EMS exceeding the scope of practice of an EMT, as authorized by the Department.

 Advisory Board—The State Advisory Board, which is the Board of Directors of the Pennsylvania Emergency Health Services Council.

 Air ambulance—A rotorcraft specifically designed, constructed or modified and equipped, used or intended to be used and maintained or operated for the purpose of providing emergency medical care to and air transportation of patients.

 Ambulance—A ground or air vehicle that is maintained or operated for the purpose of providing EMS to and transportation of patients.

 BLS—Basic life support.

 BLS ambulance—Basic life support ambulance—An ambulance that is equipped to provide EMS at or below the AEMT level and used in the transport of patients.

 BLS squad vehicle—Basic life support squad vehicle—

 (i) A vehicle that is maintained or operated to transport EMS providers, and equipment and supplies, to rendezvous with the crew of an ambulance for the purpose of providing to patients EMS at or below the AEMT level.

 (ii) The vehicle is not used in the transport of patients.

 Basic EMS—Basic emergency medical services—EMS included within but not exceeding the scope of practice of an EMT.

 Basic rescue practices technician—An individual who is certified by the Department as possessing the training and skills to perform a rescue operation as taught in a basic rescue practices technician program approved by the Department.

 Basic vehicle rescue technician—An individual who is certified by the Department as possessing the training and skills to perform a rescue from a vehicle as taught in a basic vehicle rescue technician program approved by the Department.

 Bureau—

 (i) The Bureau of Emergency Medical Services of the Department.

 (ii) If the Department is reorganized, the office within the Department assigned primary responsibility for administering the act.

 CPR—Cardiopulmonary resuscitation—Artificial circulation which is performed as a procedure when cardiac arrest occurs.

 CPR course—Cardiopulmonary resuscitation course—A course of instruction in CPR meeting the Emergency Cardiac Care Committee National Conference on CPR and Emergency Cardiac Care standards. The course shall encompass one- and two-rescuer adult, infant and child CPR, and obstructed airway methods.

 Commonwealth EMS Medical Director—Commonwealth Emergency Medical Services Medical Director—A physician who is approved by the Department to advise and formulate policy on matters pertaining to EMS.

 Continuing education—Learning activities intended to build upon the education and experience of EMS providers and EMSVOs to enhance and strengthen the quality of services provided.

 Continuing education course—A unit of continuing education for which the Department will grant an EMS provider or EMSVO continuing education credit.

 Continuing education sponsor—An entity or institution that is accredited by the Department as a sponsor of continuing education courses.

 Conviction—A judgment of guilt, a plea of guilty or a plea of nolo contendere.

 Department—The Department of Health of the Commonwealth.

 EMR—Emergency medical responder—An individual who is certified by the Department as an emergency medical responder.

 EMS—Emergency medical services—Either of the following:

 (i) The medical care, including medical assessment, monitoring, treatment, transportation and observation, which may be provided to a person in responding to an actual or reported emergency to either of the following:

 (A) Prevent or protect against loss of life or a deterioration in physiological or psychological condition.

 (B) Address pain or morbidity associated with the person's condition.

 (ii) The transportation of an individual with medical assessment, monitoring, treatment or observation of the individual who, due to the individual's condition, requires medical assessment, monitoring, treatment or observation during the transport.

 EMS agency—Emergency medical services agency—An entity that engages in the business or service of providing EMS to patients within this Commonwealth by operating one or more of the following:

 (i) An ambulance service.

 (ii) An air ambulance.

 (iii) An ALS ambulance.

 (iv) An ALS squad vehicle.

 (v) An intermediate ALS ambulance.

 (vi) An intermediate ALS squad vehicle.

 (vii) A BLS ambulance.

 (viii) A BLS squad vehicle.

 (ix) A QRS.

 (x) A special operations EMS service, which includes a tactical EMS service, a wilderness EMS service, an urban search and rescue service and a mass-gathering EMS service.

 (xi) Another vehicle or service that provides EMS outside of a health care facility as prescribed by the Department by regulation.

 EMS agency dispatch center—Emergency medical services agency dispatch center—A communications center owned, operated or controlled by an EMS agency that dispatches EMS resources due to a PSAP routing emergency callers to it for that purpose or due to the EMS agency receiving calls through an EMS agency provided telephone number through which the EMS agency invites persons to request the EMS agency's response to an emergency.

 EMS agency medical director—Emergency medical services agency medical director—A physician who is employed by, contracts with or volunteers with an EMS agency either directly or through an intermediary to evaluate the quality of patient care provided by the EMS providers utilized by the EMS agency and to provide medical guidance and advice to the EMS agency.

 EMS agency medical director course—Emergency medical services agency medical director course—A course adopted by the Department for EMS agency medical directors, which provides education in EMS medical direction.

 EMS educational institute—Emergency medical services educational institute—An institute accredited by the Department to provide education required for the certification of an EMS provider by the Department.

 EMS PCR—Emergency medical services patient care report—A report that provides standardized data and information relating to patient assessment and care.

 EMS provider—Emergency medical services provider—The term includes any of the following:

 (i) An EMR.

 (ii) An EMT.

 (iii) An AEMT.

 (iv) A paramedic.

 (v) A PHRN.

 (vi) A PHPE.

 (vii) A PHP.

 (viii) An individual prescribed by regulation of the Department to provide specialized EMS.

 EMS provider educational course—An educational course approved by the Department, other than a CPR course, the successful completion of which is a requirement for securing an EMS provider certification.

 EMS system—Emergency medical services system—The arrangement of personnel, facilities and equipment for the delivery of EMS in a geographic area to prevent and manage emergencies.

 EMS vehicle—Emergency medical services vehicle—A ground EMS vehicle or an air ambulance.

 EMSOF—Emergency Medical Services Operating Fund—Moneys appropriated to the Department under section 8153(a) of the act (relating to support of emergency medical services) and which are not assigned to the Catastrophic Medical and Rehabilitation Fund.

 EMSVO—Emergency medical services vehicle operator—An individual who is certified by the Department to operate a ground EMS vehicle.

 EMT—Emergency medical technician—An individual who is certified by the Department as an emergency medical technician.

 EVOC—Emergency vehicle operator's course.

 Emergency—A physiological or psychological illness or injury of an individual so that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect the absence of immediate EMS to result in one of the following:

 (i) Placing the health of the individual or, with respect to a pregnant woman, the health of the woman or her unborn child in serious jeopardy.

 (ii) Serious impairment of a bodily function.

 (iii) Serious dysfunction of a bodily organ or part.

 Emergency department—An area of the hospital dedicated to offering emergency medical evaluation and initial treatment to individuals in need of emergency care.

 Facility—A physical location at which an entity operates a health care facility licensed under Federal or State law.

 First responder—An individual who is certified by the Department as a first responder.

 Ground EMS vehicle—Ground emergency medical services vehicle—The term includes any of the following:

 (i) A BLS ambulance.

 (ii) A BLS squad vehicle.

 (iii) An ALS ambulance.

 (iv) An ALS squad vehicle.

 Hospital—An institution having an organized medical staff which is primarily engaged in providing to inpatients by or under the supervision of physicians, diagnostic and therapeutic services or rehabilitation services for the care or rehabilitation of injured, disabled, pregnant, diseased, sick or mentally ill persons. The term includes a facility for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not a facility caring exclusively for the mentally ill.

 Intermediate ALS ambulance—Intermediate advanced life support ambulance—An ambulance that is staffed and equipped to provide EMS at the AEMT level and used in the transport of patients.

 Intermediate ALS squad vehicle—Intermediate advanced life support squad vehicle—

 (i) A vehicle that is maintained or operated to transport EMS providers at the AEMT level, and equipment and supplies, to rendezvous with the crew of an ambulance for the purpose of providing advanced EMS to patients.

 (ii) The vehicle is not used in the transport of patients.

 Medical advisory committee—An advisory body formed to advise a regional EMS council or the Advisory Board on issues that have potential impact on the delivery of emergency medical care.

 Medical audit—A mechanism to evaluate patient care.

 Medical command course—The course adopted by the Department for medical command physicians which provides an overview of the medical command system.

 Medical command facility—A distinct unit that contains the necessary equipment and personnel for providing medical command to and direct medical oversight over EMS providers.

 Medical command facility medical director—A medical command physician who meets the criteria established by the Department to assume responsibility for the direction and control of the equipment and personnel at a medical command facility.

 Medical command order—An order issued by a medical command physician to an EMS provider who is functioning on behalf of an EMS agency.

 Medical command physician—A physician who is certified by the Department to give medical command orders to EMS providers.

 Medical coordination—A system which involves the medical community in all phases of the regional EMS system and consists of the following elements:

 (i) Designation of a regional EMS medical director.

 (ii) Responsibility for oversight to assure implementation of all medical requirements, with special emphasis on patient triage and medical treatment protocol.

 (iii) Effective emergency medical planning and recommendation for Department recognition of online command facilities with medical command physicians who give orders to EMS providers.

 (iv) Transfer and medical treatment protocols.

 (v) Technologic innovations which support the training and operations of the physicians giving orders to EMS providers.

 (vi) Technologic innovations which support the training and operations of the EMS program and an effective process for accountability—for example, records, case review and audits.

 Medical monitoring—Performing continuous or periodic observations of an individual's condition or continuation of an ordered treatment plan for an individual to prevent pain, suffering or the exacerbation of a preexisting condition.

 Medical observation—Performing continuous or periodic observations of an individual's stable condition to determine whether there is a change in that condition.

 Medical record—Documentation of the course of a patient's condition and treatment, maintained to provide communication among health care providers for current and future patient care.

 PALS course—Pediatric advanced life support course—A course in advanced pediatric life support sanctioned by the American Heart Association and the American Academy of Pediatrics.

 PHP—Prehospital emergency medical services physician—A physician who is certified by the Department as a prehospital EMS physician.

 PHPE—Prehospital physician extender—A physician assistant who is certified by the Department as a prehospital physician extender.

 PHRN—Prehospital registered nurse—A registered nurse who is certified by the Department as a prehospital registered nurse.

 PSAP—Public safety answering point—

 (i) The Pennsylvania Emergency Management Agency-approved first point at which calls for emergency assistance from individuals are answered.

 (ii) A PSAP is operated 24 hours a day.

 Paramedic—An individual who is certified by the Department as a paramedic.

 Patient—An individual for whom an EMS provider is responsible for one of the following:

 (i) Providing EMS on behalf of an EMS agency.

 (ii) Required to provide EMS on behalf of an EMS agency because the individual's condition requires or may require medical observation, monitoring, assessment or treatment for an illness, disease, injury or other disability.

 Peer review—The evaluation by health care provider of the quality and efficiency of services ordered or performed by EMS providers and physicians who direct or supervise EMS providers under the act and the regulations of the Department.

 Peer review committee—A committee of health care providers who engage in peer review under the act.

 Physician—An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth.

 QRS—Quick response service—An operation in which EMS providers of an EMS agency:

 (i) Respond to an actual, reported or perceived emergency.

 (ii) Provide EMS to patients pending the arrival of other EMS providers and resources that have been dispatched to the scene.

 Receiving facility—A facility to which an ambulance may transport a patient who requires prompt medical care in addition to that provided by EMS providers who respond to an emergency.

 Regional EMS council—Regional emergency medical services council—A nonprofit incorporated entity or appropriate equivalent that is assigned by the Department to:

 (i) Plan, develop, maintain, expand and improve EMS systems within a specific geographical area of this Commonwealth.

 (ii) Coordinate those systems into a regional EMS system.

 Regional EMS medical director—Regional emergency medical services medical director—The medical director of a regional EMS council.

 Registered nurse—An individual who has a current original or renewed license to practice nursing in this Commonwealth as a registered nurse.

 Residency program—Training approved or recognized by the State Board of Medicine or the State Board of Osteopathic Medicine as a program of graduate medical training for physicians.

 Rural area—An area outside urbanized areas as defined by the United States Bureau of the Census.

 Scope of practice—The EMS that an individual who is certified by the Department as an EMS provider is permitted to perform under the certification.

 Service area—The geographic area in which an EMS agency routinely provides EMS.

 Special event—A planned and organized activity or contest, which places participants or attendees, or both, in a defined geographic area in which the potential need for EMS exceeds local EMS capabilities or where access by emergency vehicles might be delayed due to crowd or traffic congestion at or near the event.

 Special vehicle rescue technician—An individual who is certified by the Department as possessing the training and skills to perform special rescue operations as taught in the special vehicle rescue training program approved by the Department.

 Specialty receiving facility—A facility identified by the Department as a receiving facility based upon its ability to provide specialized emergency and continuing care to patients in one of the following medical areas:

 (i) burns;

 (ii) cardiac;

 (iii) stroke;

 (iv) trauma;

 (v) other specialized care.

 Statewide EMS protocols—Statewide emergency medical services protocols—Written EMS protocols adopted by the Department that have Statewide application to the delivery of EMS by EMS providers.

 Trauma center—A facility accredited as a trauma center by the Trauma Foundation.

 Trauma Foundation—The Pennsylvania Trauma Systems Foundation, a nonprofit Pennsylvania corporation whose function is to accredit trauma centers.

§ 1021.3. Applicability.

 This subpart affects persons and activities regulated by the Department under the act.

§ 1021.4. Exceptions.

 (a) The Department may grant exceptions to, and departures from, this subpart when the policy objectives and intentions of the Department as reflected in this subpart are otherwise met or when compliance would create an unreasonable hardship, but would not impair the health, safety or welfare of the public. Exceptions or departures from this subpart will not be granted if compliance with the standard is required by statute.

 (b) Requests for exceptions to this subpart shall be made in writing to the Department. The requests, whether approved or not approved, will be documented and retained on file by the Department in accordance with its document retention schedule. Approved requests shall be retained on file by the applicant during the period the exception remains in effect.

 (c) A granted request will specify, if relevant, the period during which the exception is operative. The duration of an exception may be extended if the reasons for the original exception continue. Requests for an exception extension shall be made in writing to the Department.

 (d) An exception granted may be revoked by the Department for just cause. Just cause includes, for example, failure to meet the conditions for the exception. Notice of the revocation will be in writing and include the reason for the action of the Department and a specific date upon which the exception will be terminated.

 (e) In revoking an exception, the Department will provide for a reasonable time between the date of the written notice or revocation and the date of termination of an exception for the holder of the exception to come into compliance with this subpart. Failure to comply after the specified date may result in enforcement or disciplinary proceedings.

 (f) The Department may, on its own initiative, grant an exception to this subpart if the requirements in subsection (a) are satisfied.

§ 1021.5. Investigations.

 The Department may investigate any person, entity or activity for compliance with the act and this subpart.

§ 1021.6. Comprehensive EMS system plan.

 (a) The Department, with the advice of the Advisory Board, will develop and annually update a Statewide EMS System Plan, which will include both short-range and long-range goals and objectives for the coordinated delivery of EMS in this Commonwealth.

 (b) The plan will contain:

 (1) An inventory of EMS resources available in this Commonwealth.

 (2) An assessment of the effectiveness of the existing Statewide EMS system and a determination of the need for changes to the Statewide EMS system.

 (3) Performance measures for delivery of EMS to persons in this Commonwealth.

 (4) Methods to be used in achieving stated performance measures.

 (5) A schedule for achievement of the stated performance measures.

 (6) A method for monitoring and evaluating whether the stated Statewide performance measures are being achieved.

 (7) Estimated costs for achieving the stated performance measures.

 (c) The Department will incorporate regional EMS system plans into the Statewide EMS System Plan.

 (d) The Department will adopt a Statewide EMS System Plan, updates to the plan after public notice, an opportunity for comment and its consideration of comments received. The Department will make the plan available to the General Assembly and concerned agencies, entities and individuals who request a copy.

§ 1021.7. Comprehensive regional EMS system plan.

 (a) A regional EMS council shall develop and annually update a regional EMS system plan for coordinating and improving the delivery of EMS in the region for which it has been assigned responsibility.

 (b) The plan must contain:

 (1) An inventory of EMS resources available in the region.

 (2) An assessment of the effectiveness of the existing regional EMS system and a determination of the need for enhancement of the regional EMS system.

 (3) A statement of goals and specific measurable objectives for delivery of EMS to persons in the region.

 (4) Identification of interregional problems and recommended measures to resolve those problems.

 (5) Methods to be used in achieving stated performance measures.

 (6) A schedule for achievement of the stated performance measures.

 (7) A method for evaluating whether the stated performance measures have been achieved.

 (8) Estimated costs for achieving the stated performance measures.

 (9) Other information as requested by the Department.

 (c) A regional EMS council shall, in the course of preparing a regional EMS system plan and updates to the plan, provide public notice and an opportunity for comment. It shall consider the comments before submitting a proposed plan to the Department.

 (d) A regional EMS system plan will become final after it is approved by the Department. The regional EMS council shall make the plan available to concerned agencies, entities and individuals who request a copy.

§ 1021.8. EMS data collection.

 (a) Reasons for EMS data collection. The Department, either directly or through regional EMS councils or the Advisory Board, may collect EMS data for the purpose of evaluating the effectiveness of the Statewide and regional EMS system plans and the need to revise those plans and pursue future EMS system initiatives. This will include collecting EMS data to determine the status of the Statewide and regional EMS systems, the degree of compliance with the requirements in the act and this subpart, and the effectiveness of the Statewide and regional EMS systems in reducing morbidity and mortality when the EMS systems are involved.

 (b) Duty to provide EMS data and records. Persons regulated by the Department under the act, as well as PSAPs and others dispatchers of EMS resources, shall provide data and access to records, including audio records, without charge, as reasonably requested by the Department, the regional EMS councils or the Advisory Board when they are acting for and on behalf of the Department, to aid the Department, the regional EMS councils and the Advisory Board in conducting the activities referenced in subsection (a) and engaging in an investigation authorized under the act and this subpart.

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Subchapter B. AWARD AND ADMINISTRATION OF EMSOF FUNDING

Sec.

1021.21.	Purpose.
1021.22.	Entities eligible to receive EMSOF funds through contracts or grants.
1021.23.	Award of contract or grant to a regional EMS council.
1021.24.	Use of EMSOF funding by a regional EMS council.
1021.25.	Allocation of EMSOF funds to regional EMS councils.
1021.26.	Technical assistance.
1021.27.	Subcontracting.
1021.28.	Contracts and grants with the Advisory Board.

§ 1021.21. Purpose.

 This subchapter implements sections 8112 and 8153 of the act (relating to contracts and grants; and support of emergency medical services), which set forth the standards and criteria governing the award and administration of contracts and grants under the act that are funded by EMSOF funds.

§ 1021.22. Entities eligible to receive EMSOF funds through contracts or grants.

 The following entities are eligible to directly receive EMSOF funds from the Department through contracts and grants:

 (1) Regional EMS councils.

 (2) The Advisory Board.

 (3) Other entities to assist the Department in complying with the act.

§ 1021.23. Award of contract or grant to a regional EMS council.

 (a) EMSOF funds shall be used by a regional EMS council to plan, initiate, maintain, expand or improve a regional EMS system in a manner that is consistent with the Statewide and relevant regional EMS system plans. To apply for a contract or grant for these purposes, a regional EMS council or entity that seeks to become a regional EMS council shall submit to the Department a contract or grant application on a form prescribed by the Department in which the applicant:

 (1) Provides information on the organizational structure of the regional EMS council and its provisions to ensure representation of appropriate entities.

 (2) Addresses planning, maintenance and improvement of the applicable regional EMS system.

 (3) Demonstrates the qualifications of the applicant to plan, maintain and improve a regional EMS system.

 (b) To be awarded a contract or grant to serve as a regional EMS council, the applicant shall demonstrate to the Department's satisfaction that it has:

 (1) An appropriate organizational structure.

 (2) Made provision for the representation of appropriate entities to meet the requirements in §§ 1021.102 and 1021.103 (relating to structure of regional EMS councils; and governing body).

 (3) The qualifications and commitment to plan, maintain and improve a regional EMS system.

 (c) Upon expiration of a contract or grant with a regional EMS council, the Department, without undertaking a competitive bidding process, may enter into a new contract or grant with the same entity for that entity to continue to serve as a regional EMS council, if that entity in carrying out the prior contract or grant demonstrated its ability and commitment to the Department's satisfaction to plan, maintain and improve the regional EMS system consistent with the terms of the prior contract or grant.

§ 1021.24. Use of EMSOF funding by a regional EMS council.

 (a) A regional EMS council may receive EMSOF funding from the Department for the following purposes:

 (1) Providing public education, information, health promotion and prevention programs regarding EMS, including:

 (i) Public education programs, including CPR, first aid, instruction regarding 911 systems and how to access EMS systems.

 (ii) Public information programs, including passenger and driver safety, specialty services and EMS system awareness programs.

 (iii) Health promotion programs, including wellness of EMS workforce and EMS safety programs that promote a culture of safe practices among EMS providers.

 (iv) Prevention programs, including passenger restraint systems, prudent heart living and general health awareness, and safety practices to prevent errors in patient care and injuries to EMS providers.

 (2) Purchasing ambulances, other EMS vehicles, medical equipment and rescue equipment which enables or enhances the delivery of EMS.

 (i) Ambulances and other EMS vehicles will be considered for funding if the funds will be used for the initial acquisition of vehicles or parts, or the addition or replacement of existing vehicles or parts, by an EMS agency or an entity that qualifies for initial licensure as an EMS agency.

 (ii) Medical equipment will be considered for funding if the funds will be used to purchase medical equipment for EMS agencies.

 (iii) Rescue equipment will be considered for funding if the funds will be used to purchase rescue equipment for EMS agencies or rescue services recognized by the Department or the State Fire Commissioner.

 (3) Conducting and ensuring the reasonable availability of training and testing programs for EMS providers. Priority consideration with respect to training will be given to training programs leading to the certification of EMS providers and the continuing education of EMS providers.

 (4) Inspecting and investigating EMS agencies, educational institutes and medical facilities, and conducting other inspections and investigations to assist the Department in carrying out its regulatory responsibilities under the act.

 (5) Purchasing communications equipment and services, including medical command communications equipment, and alerting equipment for EMS purposes.

 (6) Purchasing equipment for emergency departments, if the equipment is used or intended to be used in equipment exchange programs with EMS agencies. The equipment purchased shall be of a type used by EMS agencies in the EMS provided to patients in a prehospital or interhospital setting. It shall be the type of equipment that can be easily or safely removed from the patient upon arrival or during treatment at a receiving facility.

 (7) Maintaining and operating a regional EMS council. Items eligible for funding include:

 (i) Salaries, wages and benefits of staff.

 (ii) Travel.

 (iii) Equipment and supplies.

 (iv) Leasing office space.

 (v) Other costs incidental to the conduct of the business of a regional EMS council which are found by the Department to be necessary and appropriate.

 (8) Collecting and analyzing data necessary to evaluate the effectiveness of EMS systems in providing EMS and to administer quality improvement programs. These costs may include the processing of both prehospital and hospital data and include:

 (i) Data collection.

 (ii) Data entry.

 (iii) Data processing of information.

 (iv) Data analysis and evaluation.

 (v) Data interpretation and dissemination.

 (9) Facilitating the merger of EMS agencies or assisting an EMS agency to acquire another EMS agency when the Department determines circumstances exist to the extent that the transaction and financial assistance are needed to serve the public interest.

 (10) Recruitment and retention of EMS providers by EMS agencies.

 (11) Other costs determined by the Department to be appropriate and necessary for the implementation of a comprehensive regional EMS system.

 (b) The Department will set forth additional priorities for funding on a yearly basis in a notice published in the Pennsylvania Bulletin.

 (c) Funds appropriated to the Department from the EMSOF will not be made available for the following:

 (1) Acquisition, construction or rehabilitation of facilities or buildings, except renovation as may be necessary for the implementation or modification of 911 and EMS communication systems.

 (2) Purchase of hospital equipment, other than communications equipment for medical command and receiving facilities, unless the equipment is used or intended to be used in an equipment exchange program with EMS agencies.

 (3) Maintenance of ambulances, other EMS vehicles and equipment.

 (4) Costs deemed by the Department as inappropriate for carrying out the purposes of the act.

 (5) Costs which are normally borne by patients, except for extraordinary costs as determined by the Department.

 (d) As approved by the Department, a regional EMS council may make purchases and other expenditures of funds on behalf of EMS agencies, recognized rescue services, accredited educational institutes and medical command facilities for cost-savings purposes. The Department may distribute funds to these entities to make these purchases and other expenditures of funds.

 (e) The Department, by contract, grant or notice published in the Pennsylvania Bulletin, may require a regional EMS council or entity to which a regional EMS council distributes funds to provide matching funds in specified percentages as a condition for receiving EMSOF funds.

§ 1021.25. Allocation of EMSOF funds to regional EMS councils.

 The Department will consider the following factors in determining the amount of EMSOF funding regional EMS councils receive:

 (1) The total amount of funds available.

 (2) Conformity of the application for funding to the Statewide EMS System Plan.

 (3) Financial need of the regional EMS system.

 (4) Funds available to the regional EMS council for the purpose in the application for funding, including non-State contributions, Federal grants or Federal contracts pertaining to EMS. Non-State contributions include cash and in-kind services provided to the contractor or toward the operation of a regional EMS system by private, public or government entities, including the Federal government.

 (5) Geographic area.

 (6) Population of the geographic area served by the applicant.

 (7) Special rural needs of the geographic area served by the applicant.

 (8) Potential duplication of services.

 (9) Priorities of the Department.

 (10) Other factors set forth by the Department in a notice published in the Pennsylvania Bulletin.

§ 1021.26. Technical assistance.

 (a) Regional EMS councils that obtain contracts or grants from the Department may request technical assistance from the Department, if necessary, for the purpose of carrying out their contracts or grants. Special consideration will be given to regional EMS councils that serve rural areas to assist with matters such as recruitment, retention of EMS providers, EMS agency management and the use of EMS agency equipment.

 (b) Technical assistance from the Department may also be available to subcontractors or other recipients of funds from the regional EMS council when technical assistance resources are not available from the regional EMS council.

 (c) Examples of technical assistance resources include:

 (1) Communications assistance.

 (2) Public education resources.

 (3) Information management sources.

§ 1021.27. Subcontracting.

 (a) A regional EMS council may receive the Department's written approval to subcontract certain of its duties to other entities as deemed necessary and appropriate for the proper execution of the contract or grant with the Department.

 (b) A regional EMS council may not execute a subcontract until the Department determines in writing that the subcontract is necessary and appropriate.

§ 1021.28. Contracts and grants with the Advisory Board.

 Sections 1021.22—1021.27 do not apply to contracts or grants between the Department and the Advisory Board. The Department will enter into a contract or grant with the Advisory Board to perform the services the Advisory Board is required to perform under the act. The Department may contract with the Advisory Board for it to assist the Department in complying with other provisions of the act.

Subchapter C. COLLECTION OF DATA AND INFORMATION

Sec.

1021.41.	EMS patient care reports.
1021.42.	Dissemination of information.
1021.43.	Vendors of EMS patient care reports.

§ 1021.41. EMS patient care reports.

 (a) EMS agencies shall collect, maintain and electronically report complete, accurate and reliable patient data and other information as solicited on the EMS PCR form for calls for assistance in the format prescribed by the Department. An EMS agency shall file the report for calls to which it responds that result in EMS being provided. The report shall be made by completing an EMS PCR within the time prescribed by the EMS agency's written policies, no later than 72 hours after the EMS agency concludes patient care, and then submitting it, within 30 days, to the regional EMS council that is assigned responsibilities for the region in which the EMS agency initially encounters the patient. An entity located out-of-State, but licensed as an EMS agency by the Department, shall file its EMS PCRs with the regional EMS council with which it has been directed to file its EMS PCRs by the Department. The Department will publish a list of the data elements and the form specifications for the EMS PCR form in a notice in the Pennsylvania Bulletin and on the Department's web site. The reporting shall conform to the requirements in the notice published in the Pennsylvania Bulletin. The Department will maintain a list of software it has determined to satisfy the requirements for electronic reporting.

 (b) When an EMS provider relinquishes primary responsibility for the care of a patient to another EMS provider, the EMS provider relinquishing that responsibility shall provide the other EMS provider with the patient information that has been collected.

 (c) When an EMS agency transports a patient to a receiving facility, before its ambulance departs from the receiving facility, the EMS agency having primary responsibility for the patient shall verbally and in writing or other means by which information is recorded report to the individual at the receiving facility assuming responsibility for the patient, the patient information that is essential for immediate transmission for patient care. The Department will publish a notice in the Pennsylvania Bulletin specifying the types of patient information that are essential for patient care. The EMS agency shall provide the completed EMS PCR to the receiving facility to which the patient was transported within 72 hours after the EMS agency concluded patient care. Upon request of any other facility that subsequently provides health care services to the patient related to the reason the patient was transported to the original receiving facility, the EMS agency shall provide the completed EMS PCR to that facility within 24 hours of the request or within 72 hours after the EMS agency concluded patient care, whichever is later. The EMS agency shall submit the data to the facility in a mutually acceptable manner to the facility and the EMS agency which ensures the confidentiality of information in the EMS PCR.

 (d) An EMS agency shall have a policy for designating which member of its responding crew is responsible for completing an EMS PCR. The designated EMS provider shall ensure that the EMS PCR is accurate and complete and completed within the time prescribed by the EMS agency under subsection (a). When a patient is transported to a receiving facility, an EMS provider of the EMS agency having primary responsibility for the patient shall also ensure that before the ambulance departs from the receiving facility essential patient information is reported to the receiving facility as required under subsection (c).

 (e) The EMS agency shall retain a copy of the EMS PCR for a minimum of 7 years.

§ 1021.42. Dissemination of information.

 (a) A person who collects, has access to or knowledge of information collected under § 1021.41 (relating to EMS patient care reports), by virtue of that person's participation in the Statewide EMS system, may not provide the EMS PCR, or disclose the information contained in the report or a report or record thereof, except:

 (1) To another person who by virtue of that person's office as an employee of the Department or a regional EMS council is entitled to obtain the information.

 (2) For research or EMS planning purposes approved by the Department, subject to strict supervision by the Department to ensure that the use of the data is limited to the specific research or planning and that appropriate measures are taken to protect patient confidentiality.

 (3) To the patient who is the subject of the report or to a person who is authorized to exercise the rights of the patient with respect to securing the information, such as a person appointed as the patient's health care agent under a health care power of attorney.

 (4) Under an order of a court of competent jurisdiction, including a subpoena when it constitutes a court order, except when the information is of a nature that disclosure under a subpoena is not authorized by law.

 (5) For the purpose of quality improvement or peer review activities, with strict attention to patient confidentiality.

 (6) For the purpose of data entry/retrieval and billing, with strict attention to patient confidentiality.

 (7) As authorized under § 1021.41.

 (8) To a health care provider to whom a patient's medical record may be released under law.

 (b) The Department or a regional EMS council may disseminate nonconfidential, statistical data collected from EMS PCRs to EMS agencies and other participants in the Statewide EMS system for improvement of services.

§ 1021.43. Vendors of EMS patient care reports.

 (a) An EMS agency shall submit EMS PCRs as required under § 1021.41 (relating to EMS patient care reports) by using only a software program approved by the Department.

 (b) A vendor may not sell or otherwise provide or offer reporting forms or software marketed as appropriate for use in making EMS PCRs unless the vendor submits the product to the Department for review and receives the Department's approval. This also applies to a substantive modification the vendor makes to the reporting form or software. The vendor shall apprise the Department of the modification before marketing the modified form or software regardless of whether the vendor considers the modification to be substantive. EMS agencies may ascertain which vendor products have been approved by the Department under this subsection by contacting the Bureau.

 (c) If the Department makes changes to the minimum data elements of the EMS PCR, the Department will publish a notice of the changes in the Pennsylvania Bulletin. The effective date of the changes will not be less than 60 days after publication of the notice.

 (d) After publication of the changes, a vendor may not market as appropriate for making EMS PCRs a product that had been approved by the Department prior to the Department publishing the notice of changes, unless the vendor clearly discloses that the forms or software were approved prior to the publication of the changes and may only be used to make EMS PCRs until the changes go into effect.

 (e) A vendor may store EMS PCR data on its server for data entry or processing purposes arranged by an EMS agency or a regional EMS council to facilitate the transmission of EMS PCR information among the EMS agency, a receiving facility and the regional EMS council, but may not transmit or provide access to that data to any other entity, except the Department, and may not use the data for any other purpose.

Subchapter D. QUALITY IMPROVEMENT AND PEER REVIEW

Sec.

1021.61.	Components of Statewide quality improvement program.
1021.62.	Regional quality improvement programs.
1021.63.	Peer review.
1021.64.	Cooperation.

§ 1021.61. Components of Statewide quality improvement program.

 (a) The Department, in conjunction with the Advisory Board, will identify the necessary components for a Statewide EMS quality improvement program for the Statewide EMS system. The Statewide EMS quality improvement program shall be operated to monitor the delivery of EMS.

 (b) The Department will develop and update a Statewide EMS Quality Improvement Plan in which it will establish goals and reporting thresholds.

§ 1021.62. Regional quality improvement programs.

 A regional EMS council, after considering input from participants in and persons served by the regional EMS system, shall develop, update and implement a regional EMS quality improvement program to monitor the delivery of EMS, which addresses, at a minimum, the quality improvement components identified by the Department. A regional EMS council quality improvement program shall:

 (1) Conduct quality improvement audits of the regional EMS system including reviewing the quality improvement activities conducted by the EMS agency medical directors and medical command facilities within the region.

 (2) Have a regional quality improvement committee that, in conjunction with the regional medical advisory committee, shall recommend to the regional EMS council ways to improve the delivery of EMS within the region based upon State and regional goals.

 (3) Develop and implement a regional EMS quality improvement plan to assess the EMS system in the region.

 (4) Investigate complaints concerning the quality of care rendered and forward recommendations and findings to the Department.

 (5) Submit to the Department reports as prescribed by the Department.

§ 1021.63. Peer review.

 (a) Persons subject to peer review. Peer review under this section may be conducted of EMS providers, EMS agency medical directors and medical command physicians.

 (b) Purpose. The purpose of peer review conducted under this section is to evaluate the quality and efficiency of services performed under this part by EMS providers, EMS agency medical directors and medical command physicians. This includes reviews to:

 (1) Evaluate and improve the quality of EMS rendered.

 (2) Determine whether the direction and supervision of EMS providers was in accordance with accepted standards.

 (3) Determine whether the EMS provided or not provided was in accordance with accepted standards of care.

 (c) Composition of peer review committee. A peer review committee established under this section may include health care providers such as EMS providers, EMS agency medical directors and other physicians, nurses, physician assistants, EMS agency managers and administrators, hospital personnel with expertise in quality assurance and PSAP dispatchers and administrators.

 (d) Proceedings and records of a peer review committee. The proceedings and records of a peer review committee conducted under this section have the same protections from discovery and introduction into evidence in civil proceedings as they would under the Peer Review Protection Act (63 P. S. §§ 425.1—425.4). A person who attends a meeting of a peer review committee has the same right as a person who attends a meeting of a review organization under the Peer Review Protection Act with respect to not testifying in a civil action as to evidence or other matters produced or presented during the peer review proceeding or as to findings, recommendations, evaluations opinions or other actions of the peer review committee or other records thereof. These protections do not apply to records that are reviewed in peer review, but were not created for the sole purpose of being reviewed in a peer review proceeding. A person who testifies before a peer review committee or who is a member of a peer review committee is not protected from testifying as to matters within that person's knowledge, except as to that person's testimony before the peer review committee, matters learned by that person through that person's participation in the peer review committee's proceeding or opinions formed by that person as a result of the peer review proceeding.

 (e) Persons who provide information to a peer review committee. A person who provides information to a peer review committee conducting peer review under this section has the same protections from civil and criminal liability as a person who provides information to a review organization under the Peer Review Protection Act.

 (f) Members and employees of a peer review committee and persons who furnish professional services to a peer review committee. An individual who is a member or employee of a peer review committee or who provides professional services to a peer review committee conducting peer review under this section has the same protections from civil and criminal liability for the performance of any duty, function or activity required of the peer review committee as a person who performs the duty, function or activity under the Peer Review Protection Act.

§ 1021.64. Cooperation.

 Each individual and entity licensed, certified, recognized, accredited or otherwise authorized by the Department to participate in the Statewide EMS system shall cooperate in the Statewide and regional EMS quality improvement programs and peer reviews conducted under the act and this subchapter and shall provide information, data, reports and access to records, including audio records, as reasonably requested by quality improvement and peer review committees to conduct reviews.

Subchapter E. TRAUMA CENTERS

Sec.

1021.81.	Purpose.
1021.82.	Requirements.
1021.83.	Complaints.

§ 1021.81. Purpose.

 The purpose of this subchapter is to integrate trauma centers into the Statewide EMS system by providing access to trauma centers and for the effective and appropriate utilization of resources.

§ 1021.82. Requirements.

 To ensure that trauma centers are integrated into the Statewide EMS system, trauma centers shall:

 (1) Maintain a dedicated telephone number to allow for access by referring hospitals to make arrangements for the most appropriate and expeditious mode of transportation to the trauma center, as well as allow for direct consultation between the two facilities prior to transfer and during the course of treatment of the patient.

 (2) Develop and implement outreach education programs to be offered to referring hospitals and emergency services dealing with management of major and multiple systems trauma patients and the capabilities of the trauma center.

 (3) Develop and institute a system to ensure the provision of patient outcome and treatment information to the transferring facility and the EMS agency involved in transporting the patient to the transferring facility, if the patient was transferred to the trauma center, or to the EMS agency involved in transporting the patient to the trauma center if the patient was not transferred to the trauma center by another facility, on each patient transported to the trauma center by ambulance.

 (4) Maintain a medical command facility to allow for communication between a transporting ground ambulance or air ambulance and the trauma center to ensure that patient information and condition updates are available to the trauma center and that medical consultation is available to the transporting ambulance crew. The capabilities shall be in accordance with regional and Statewide EMS telecommunications plans.

§ 1021.83. Complaints.

 The Department will investigate complaints related to the delivery of services by trauma centers and forward the results of the investigation to the Trauma Foundation with a recommendation for action.

Subchapter F. REGIONAL EMS COUNCILS

Sec.

1021.101.	Designation of regional EMS councils.
1021.102.	Structure of regional EMS councils.
1021.103.	Governing body.
1021.104.	Responsibilities of regional EMS councils.

§ 1021.101. Designation of regional EMS councils.

 (a) The Department will designate a regional EMS council that satisfies the structural and representation requirements in § 1021.102 (relating to structure of regional EMS councils) for each geographic area of this Commonwealth that the Department designates as a regional EMS geographic area for regional EMS system purposes.

 (b) The designation of the geographical area will be based on the capability to:

 (1) Provide definitive care services to the majority of general, emergent and critical patients.

 (2) Establish community-wide and regional care programs.

 (3) Interact and liaison with hospitals, other health care facilities and important public health and public safety entities.

 (c) The Department will evaluate the performance and effectiveness of each regional EMS council on a periodic basis to assure that each council is appropriately meeting the needs of the EMS region to which it is assigned in planning, developing, maintaining, expanding, improving and upgrading the regional EMS system.

§ 1021.102. Structure of regional EMS councils.

 (a) Regional EMS councils shall be organized by one of the following:

 (1) A unit of general local government with an advisory council.

 (2) A representative public entity administering a compact or other area wide arrangement or consortium.

 (3) A public or private nonprofit entity.

 (b) If the regional EMS council is a unit of local government it shall have an advisory council which is determined by the Department to be representative of health care consumers, the health professions, and major private, public and volunteer agencies, organizations and institutions concerned with providing EMS.

 (c) A regional EMS council shall have a governing body.

 (d) A regional EMS council shall have a director who is approved by the Department.

 (e) A regional EMS council shall have a medical director and establish committees which are necessary to carry out the responsibilities of the regional EMS council.

§ 1021.103. Governing body.

 (a) If the regional EMS council is a public or private nonprofit organization, its governing body shall satisfy the representation requirements in § 1021.102 (relating to structure of regional EMS councils).

 (b) If the governing body consists of a board, it shall adopt written policies which include:

 (1) A method of selection for board membership.

 (2) Qualifications for board membership.

 (3) Criteria for continued board membership.

 (4) Frequency of meetings.

 (c) The duties of the governing body shall include:

 (1) Selecting a director who will be responsible for the daily operations of the regional EMS council.

 (2) Selecting a regional EMS medical director.

 (3) Describing the organizational structure.

 (4) Establishing appropriate committees, including a quality improvement committee and a medical advisory committee.

 (i) A majority of the members of the medical advisory committee shall be physicians.

 (ii) The regional medical advisory committee shall assist the regional EMS medical director in matters of medical coordination and ensure that EMS is provided within the region in a manner that considers patient safety and the quality of EMS.

 (5) Monitoring and ensuring the regional EMS council's compliance with contracts and grants from the Department.

 (d) The governing body shall make available to the public an annual report which includes:

 (1) Activities and accomplishments of the preceding year.

 (2) A financial statement of income and expenses.

 (3) A statement disclosing the names of officers and directors.

 (e) A staff member of a regional EMS council may not serve as a voting member of the governing body.

§ 1021.104. Responsibilities of regional EMS councils.

 In addition to other responsibilities imposed upon regional EMS councils by this subpart, regional EMS councils have responsibility for:

 (1) Organizing, maintaining, implementing, expanding and improving the EMS system within the geographic area for which the regional EMS council has been assigned responsibilities.

 (2) Developing and implementing comprehensive EMS plans, as approved by the Department.

 (3) Advising PSAPs and municipal and county governments as to EMS resources available for dispatching and recommending dispatching criteria that may be developed by the Department, or by the regional EMS council as approved by the Department.

 (4) Developing, maintaining, implementing, expanding and improving programs of medical coordination. The programs are subject to approval by the Department.

 (5) Providing input to hospitals, upon their request, in the development and coordination of a comprehensive written EMS plan.

 (6) Assisting the Department in achieving a unified Statewide EMS system and regional EMS system components and goals as described in section 8105 of the act (relating to duties of department).

 (7) Assisting the Department in the collection and maintenance of standardized data and information provided through EMS PCRs.

 (8) Providing EMS agencies with data summary reports.

 (9) Assuring the reasonable availability of training programs, including continuing education programs, for EMS providers. The programs must include those that lead to certification of EMS providers by the Department. Regional EMS councils may also develop and implement additional educational programs.

 (10) Monitoring EMS provider, EMS agency, EMS agency medical director, medical command physician, medical command facility medical director and medical command facility compliance with minimum standards established by the Department.

 (11) Facilitating the integration of medical command facilities into the regional EMS system in accordance with policies and guidelines established by the Department.

 (12) Developing and implementing regional protocols for issues of regional importance that are not addressed by the Statewide EMS protocols. Protocols shall be developed in consultation with the regional EMS council's medical advisory committee and approved by the Department. Protocols must:

 (i) Be consistent with the Department's established protocol format.

 (ii) Address matters the Department directs regional EMS councils to address.

 (iii) Be distributed to EMS agencies within the region.

 (iv) Be reviewed annually and revised as necessary in consultation with the regional EMS council's medical advisory committee.

 (v) Be consistent with Chapter 1023 (relating to personnel) which governs the scope of practice of EMS providers.

 (vi) Be based upon accepted standards of emergency medical care, with consideration given to maximizing patient safety.

 (13) Assisting Federal, State and local agencies, upon request, in the provision of onsite mitigation, technical assistance, situation assessment, coordination of functions or post-incident evaluations, in the event of a potential or actual disaster, mass casualty situation or other substantial threat to public health.

 (14) Maintaining an inventory of EMS resources, including EMS providers, available in the EMS region and promoting the recruitment, retention and recognition of EMS providers.

 (15) Designating a regional EMS medical director.

 (16) Supervising the regional EMS medical director to assure that the roles and responsibilities in § 1023.4 (relating to regional EMS medical director) are carried out.

 (17) Assisting EMS providers, other persons and EMS agencies operating in the regional EMS system to meet the licensure, certification, registration and continuing education requirements established under the act and this subpart, and assisting the Department in ensuring that those requirements are met.

 (18) Having a conflict of interest policy and requiring its employees and officials to agree to the policy in writing.

 (19) Assisting the Department in carrying out the act and this part and adhering to policy direction established by the Department.

 (20) Performing other duties deemed appropriate by the Department for the initiation, expansion, maintenance and improvement of the regional and Statewide EMS system which are in accordance with the Statewide EMS System Plan.

Subchapter G. ADVISORY BOARD

Sec.

1021.121.	Duties and purpose.
1021.122.	Meetings and members.
1021.123.	Disasters.

§ 1021.121. Duties and purpose.

 (a) The Advisory Board shall advise the Department on EMS issues that relate to the following:

 (1) Manpower and training.

 (2) Communications.

 (3) EMS agencies.

 (4) The content of EMS PCRs.

 (5) The content of rules and regulations.

 (6) Standards and policies promulgated by the Department.

 (7) The permitted scope of continuing education courses.

 (8) Other subjects as required by the act or deemed appropriate by the Department or the Advisory Board.

 (9) The content of the Statewide EMS System Plan and proposed revisions to it.

 (b) The Advisory Board shall adopt written policies which include:

 (1) A method of selection for board membership.

 (2) Qualifications for Advisory Board membership.

 (3) Criteria for continued Advisory Board membership.

 (4) Frequency of meetings.

 (c) The Advisory Board shall:

 (1) Select a director who is responsible for the daily operations of the Advisory Board and the Pennsylvania Emergency Health Services Council.

 (2) Describe its organizational structure.

 (3) Establish appropriate committees, including an EMS for children advisory committee to advise on a program to address the emergency medical needs of the pediatric population, and a medical advisory committee with a majority of its members being physicians.

 (d) The Advisory Board shall make available to the public an annual report which must include:

 (1) A description of its activities and accomplishments of the preceding year.

 (2) A financial statement of income and expenses.

 (3) A statement disclosing the names of officers and members of the Advisory Board.

§ 1021.122. Meetings and members.

 (a) Meetings of the Advisory Board shall be held in accordance with 65 Pa.C.S. Chapter 7 (relating to Sunshine Act) or a successor act.

 (b) A voting member of the Advisory Board shall serve a 3-year term. A voting member may not serve more than two consecutive terms.

 (c) A simple majority of the voting members of the Advisory Board constitutes a quorum for the transaction of business.

 (d) A member of the Advisory Board shall serve without compensation, except for reimbursement of reasonable expenses incurred by members while performing official duties.

 (e) A staff member of the Pennsylvania Emergency Health Services Council may not serve as a voting member of the Advisory Board.

§ 1021.123. Disasters.

 In the event of a potential or actual disaster, mass casualty situation or other substantial threat to public health, the Advisory Board shall, upon request, assist Federal, State and local agencies in the provision of onsite mitigation, technical assistance, situation assessment, coordination of functions or post-incident evaluations. Recruitment of volunteer expertise available to the Advisory Board will be requested and utilized as conditions and circumstances necessitate.

Subchapter H. EMS RESEARCH

Sec.

1021.141.

Research.

§ 1021.141. Research.

 (a) Prior to engaging in a clinical investigation or study that relates to the provision of EMS, the principal investigator shall file with the Department a report of the planned investigation or study on a form prescribed by the Department. The principal investigator shall also file with the Department a report at the conclusion of the investigation or study and status reports as requested by the Department.

 (b) A person who wants to secure from the Department or a regional EMS council and use, for research purposes, information collected by the Department or a regional EMS council through EMS PCRs, or information collected by the Department or a regional EMS council regarding patients who utilize emergency departments without being admitted to a hospital or who are admitted to a hospital through emergency departments, trauma centers or directly to special care units, shall submit the proposed research project to the Department. If the Department concludes that the proposed use of the information would serve the public interest, it may refer the proposal to the medical advisory committee of the Advisory Board or to one or more of the medical advisory committees of the regional EMS councils for review and recommendation.

 (c) If access to and use of the information requested under subsection (b) is approved by the Department, the Department will release or direct the release of the information for the research project under conditions specified by the Department.

 (d) A research proposal submitted under subsection (b) must include and address the following in a format specified by the Department:

 (1) A specific statement of the hypothesis to be investigated and the clinical significance of the hypothesis.

 (2) A specific description of the methodology to be used in the research.

 (3) An estimated duration of the research.

 (4) An explanation of how patient confidentiality will be protected.

 (5) A letter from the principal investigator in which that person identifies himself as the principal investigator and assumes responsibility for compliance with the conditions imposed by the Department.

 (6) A plan for providing the Department with progress reports, annually at a minimum, and a final report on the research.

 (e) If institutional review board approval is required by law, the Department will not approve access to the requested information until it receives evidence of institutional review board approval.

 (f) The Department may direct that the use of the information be terminated if the Department determines that the use of the information fails to satisfy the conditions under which the Department approved use of the information.

 (g) An EMS agency or other person that intends to conduct research that would involve an EMS agency violating this part or an EMS protocol adopted or approved by the Department shall apply for an exception to the regulation or protocol under § 1021.4 (relating to exceptions).

 (h) This section does not empower the Department to approve research that involves any act otherwise prohibited by law.

CHAPTER 1023. PERSONNEL

Subchap.

A.	ADMINISTRATIVE AND SUPERVISORY EMS PERSONNEL
B.	EMS PROVIDERS AND VEHICLE OPERATORS
C.	OTHER PERSONS ASSOCIATED WITH THE STATEWIDE EMS SYSTEM

Subchapter A. ADMINISTRATIVE AND SUPERVISORY EMS PERSONNEL

Sec.

1023.1.	EMS agency medical director.
1023.2.	Medical command physician.
1023.3.	Medical command facility medical director.
1023.4.	Regional EMS medical director.
1023.5.	Commonwealth EMS Medical Director.

§ 1023.1. EMS agency medical director.

 (a) Roles and responsibilities. An EMS agency medical director is responsible for:

 (1) Providing medical guidance and advice to the EMS agency, including:

 (i) Reviewing the Statewide EMS protocols and Department-approved regional EMS protocols that are applicable to the EMS agency and ensuring that its EMS providers and other relevant personnel are familiar with the protocols applicable to the EMS agency.

 (ii) Performing medical audits of EMS provided by the EMS agency's EMS providers.

 (iii) Participating in and reviewing quality improvement and peer reviews of EMS provided by the EMS agency.

 (iv) Reviewing regional mass casualty and disaster plans and providing guidance to the EMS agency regarding its provision of EMS under those plans.

 (v) Providing guidance to the EMS agency, when applicable, with respect to the ordering, stocking and replacement of medications, and compliance with laws and regulations impacting upon the EMS agency's acquisition, storage and use of those medications.

 (vi) Making an initial assessment of each EMS provider at or above the AEMT level to determine whether the EMS provider has the knowledge and skills to competently perform the skills within the EMS provider's scope of practice, and a commitment to adequately perform other functions relevant to the EMS provider providing EMS at that level. This paragraph does not apply if the EMS provider was working for the EMS agency at the same level prior to the physician becoming the medical director for the EMS agency and the EMS provider was credentialed at that EMS agency within the last 12 calendar months as being able to perform at the EMS provider's certification level.

 (vii) Making an assessment, within 12 calendar months of the last assessment, of each EMS provider at or above the AEMT level to determine whether the EMS provider has demonstrated competency in the knowledge and skills to perform the skills within the EMS provider's scope of practice, and a commitment to adequately perform other functions relevant to the EMS provider providing EMS at that level.

 (viii) Recommending to the EMS agency that an EMS provider not be permitted to provide EMS at the EMS provider's certification level if the EMS agency medical director determines that the EMS provider has not demonstrated competency in the knowledge and skills to perform the skills within the EMS provider's scope of practice, or a commitment to adequately perform other functions relevant to the EMS provider providing EMS at that level, and recommending restrictions on the EMS provider's practice for the EMS agency, if appropriate, to ensure patient safety.

 (ix) Providing medical direction for the EMS agency dispatch center if the EMS agency operates an EMS agency dispatch center.

 (2) Maintaining a liaison with the regional EMS medical director.

 (3) Participating in the regional and Statewide quality improvement programs.

 (4) Recommending to the relevant regional EMS council, when appropriate, EMS protocols for inclusion in the Statewide and regional EMS protocols.

 (5) Recommending to the Department the suspension, revocation or restriction of an EMS provider's certification.

 (b) Minimum qualifications. To qualify and continue to function as an EMS agency medical director, an individual shall:

 (1) Be a physician.

 (2) Satisfy one of the following:

 (i) Have successfully completed an emergency medicine residency program accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.

 (ii) Have successfully completed a residency program in surgery, internal medicine, family medicine, pediatrics or anesthesiology, accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine. The physician shall also have successfully completed or taught the ACLS course within the preceding 2 years and have completed, at least once, the ATLS course and PALS course or APLS course, or other programs determined by the Department to meet or exceed the standards of these programs.

 (iii) Have served as an ALS medical director under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)) prior to February 16, 2010.

 (3) Have a valid Drug Enforcement Agency number.

 (4) Have completed an EMS agency medical director course or an EMS fellowship or other EMS training program that is determined by the Department to be equivalent. This training shall assure that the EMS agency medical director has knowledge of:

 (i) The scope of practice of EMS providers.

 (ii) The provision of EMS under Statewide EMS protocols.

 (iii) The interface between EMS providers and medical command physicians.

 (iv) Quality improvement and peer review principles.

 (v) Emergency medical dispatch principles and EMS agency communication capabilities.

 (vi) EMS system design and operation.

 (vii) Federal and State laws and regulations regarding EMS.

 (viii) Regional and State mass casualty and disaster plans.

 (ix) Patient and EMS provider safety principles.

§ 1023.2. Medical command physician.

 (a) Roles and responsibilities. A medical command physician functions under the direction of a medical command facility medical director and the auspices of a medical command facility. A medical command physician is responsible for:

 (1) Providing medical command orders to EMS providers whenever they seek direction.

 (2) Issuing medical command orders consistent with Statewide protocols and protocols that are in effect either in the region in which EMS originates or the region from which the EMS providers who are providing EMS begin receiving medical command direction. For good cause, a medical command physician may give medical command orders that are inconsistent with these protocols.

 (3) Documenting patient information received from EMS providers and medical command orders given to EMS providers if providing medical command at the scene.

 (b) Minimum qualifications. To qualify and continue to function as a medical command physician, an individual shall be serving as a medical command physician immediately prior to February 16, 2010, or:

 (1) Complete an application for medical command physician certification on a form or through an electronic application process, as prescribed by the Department.

 (2) Be a physician.

 (3) Satisfy one of the following:

 (i) Have successfully completed a residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.

 (ii) Have had an emergency medicine practice in another jurisdiction and establish to the Department that the physician has a combination of training, education and emergency medicine practice that makes the physician qualified to serve as a medical command physician.

 (iii) Have successfully completed or taught the ACLS course within the preceding 2 years and have completed or taught the ATLS course and either an APLS or PALS course or other program determined by the Department to meet or exceed the standards of these programs.

 (4) Have an arrangement with a medical command facility to serve as a medical command physician for that facility after receiving certification as a medical command physician.

 (5) Be practicing as an emergency medicine physician, be participating as a resident in a second or subsequent year in an emergency medicine residency program accredited by an accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine or have had at least 3 years of experience as a full-time emergency medicine physician.

 (6) Have a current Drug Enforcement Agency (DEA) number or be an emergency medicine resident in an emergency medicine residency program accredited by an accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine who is authorized to use a hospital's DEA number for practice within the emergency medicine residency program.

 (7) Have successfully completed the medical command course.

 (c) Triennial registration. A medical command physician's certification is deemed registered for 3 years. Thereafter, a medical command physician shall triennially register the certification on a form or through an electronic process, as prescribed by the Department. The Department will issue a new registration within 30 days after the application for registration is filed if the application demonstrates that the medical command physician:

 (1) Maintains licensure as a physician.

 (2) Has an arrangement with a medical command facility to serve as a medical command physician for that facility.

 (3) Is practicing as an emergency medicine physician or has had at least 3 years of experience as a full-time emergency medicine physician.

 (4) Has completed the most recent update or refresher course that the Department provided on Statewide and other applicable Department-approved EMS protocols.

§ 1023.3. Medical command facility medical director.

 (a) Roles and responsibilities. A medical command facility medical director is responsible for the following for the medical command facility:

 (1) Medical command.

 (2) Quality improvement.

 (3) Liaison with regional EMS medical director.

 (4) Participation in prehospital training activities.

 (5) Clinical and continuing education training of EMS providers.

 (6) Verifying to the Department that an applicant for medical command physician certification has an arrangement to serve as a medical command physician for the medical command facility under the direction of the medical command facility medical director and meets all medical command physician certification requirements.

 (7) Monitoring the operation of the medical command facility and the performance of its medical command physicians to ensure that they are satisfying all statutory and regulatory requirements.

 (8) Reviewing a departure from the Statewide EMS protocols of one of the facility's medical command physicians when requested by the Department and apprising the Department whether the medical command facility medical director believes there is good cause for the departure.

 (b) Minimum qualifications. To qualify and continue to function as a medical command facility medical director, an individual shall be serving as a medical command facility medical director immediately prior to February 16, 2010, or:

 (1) Complete an application for medical command facility medical director certification on a form or through an electronic application process, as prescribed by the Department.

 (2) Currently serve as a medical command physician.

 (3) Satisfy one of the following:

 (i) Have completed a residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.

 (ii) Have completed a residency program in surgery, internal medicine, family medicine, pediatrics or anesthesiology accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine and completed or taught the ACLS course within the preceding 2 years, the ATLS course and either an APLS or PALS course or other program determined by the Department to meet or exceed the standards of these programs.

 (4) Have experience in prehospital and emergency department care of the acutely ill or injured patient.

 (5) Have experience in providing medical command direction to EMS providers.

 (6) Have experience in the training of EMS providers above and below the AEMT level.

 (7) Have experience in the medical audit, review and critique of EMS providers above and below the AEMT level.

 (8) Have an arrangement with a medical command facility to serve as its medical director after receiving certification as a medical command facility medical director.

 (c) Triennial registration. A medical command facility medical director's certification is deemed registered for 3 years. Thereafter, a medical command facility medical director shall triennially register the certification on a form or through an electronic process, as prescribed by the Department. The Department will issue a new registration within 30 days after the application for registration is filed if the application demonstrates that the medical command facility medical director shall be:

 (1) Serving as a medical command physician and a medical command facility medical director for a medical command facility.

 (2) Providing prehospital and emergency department care of acutely ill or injured patients.

 (3) Performing medical audit, review and critique of EMS providers above and below the AEMT level.

§ 1023.4. Regional EMS medical director.

 (a) Roles and responsibilities. A regional EMS medical director shall carry out the following duties:

 (1) Maintain liaison with the Commonwealth EMS Medical Director.

 (2) Assist the regional EMS council, after consultation with the regional medical advisory committee, to establish and revise, subject to Department approval, regional EMS protocols.

 (3) Assist the regional EMS council to develop, subject to Department approval, criteria to recommend to PSAPs for emergency medical dispatch, including criteria for prearrival instructions, level of care to be dispatched to respond to various clinical conditions, types of EMS resources to be sent and mode of EMS resource response.

 (4) Serve as a member of the regional EMS council's quality improvement committee and as that committee's liaison to the regional EMS council's medical advisory committee.

 (5) Serve on the State EMS Quality Improvement Committee.

 (6) Serve as chairperson of the regional EMS council's medical advisory committee.

 (7) Assist, as appropriate, the regional EMS council in its investigations, analysis of investigation information and recommendations to make to the Department on actions the Department should pursue, if any, against certifications, licenses, accreditations and other authorizations issued by the Department under the act.

 (8) Review regional plans, procedures and processes for compliance with State standards of EMS.

 (b) Minimum qualifications. A regional EMS medical director shall have the following qualifications:

 (1) Be a physician.

 (2) Experience in prehospital and emergency department care of the acutely ill or injured patient.

 (3) Experience as a medical command physician and as an EMS agency medical director or as an ALS service medical director under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)).

 (4) Completed a residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine or have served as a medical command physician in this Commonwealth prior to October 14, 2000.

 (5) Experience in the training of EMS providers above and below the AEMT level.

 (6) Experience in the medical audit, review and critique of EMS providers above and below the AEMT level.

 (c) Disclosure. A regional EMS medical director shall disclose to a regional EMS council and the Department all financial or other interest in entities regulated by the Department under the act and in other matters which present a potential conflict of interest.

§ 1023.5. Commonwealth EMS Medical Director.

 (a) Roles and responsibilities. The Commonwealth EMS Medical Director is responsible for:

 (1) Providing medical advice and recommendations to the Department regarding the EMS system.

 (2) Assisting in the development and implementation of a Statewide EMS quality improvement program.

 (3) Evaluating and making recommendations on regional EMS quality improvement programs and on programs to improve patient and provider safety and provider wellness.

 (4) Assisting the Department in revising or modifying the scope of practice of EMS providers.

 (5) Providing advice and guidance to the Department on investigations and the pursuit of disciplinary actions against EMS providers and other persons and entities regulated by the Department under the act.

 (6) Reviewing, evaluating and making recommendations for the Statewide EMS protocols.

 (7) Reviewing, evaluating and making recommendations regarding regional EMS protocols that supplement Statewide EMS protocols.

 (8) Providing direction and guidance to the regional EMS medical directors for training and quality improvement monitoring and assistance.

 (9) Meeting with representatives and committees of regional EMS councils and the Advisory Board as necessary and as directed by the Department to provide guidance and direction.

 (10) Reviewing, evaluating and making recommendations to the Department on requests, for research purposes, for data made confidential by the act.

 (11) Assisting the Department in the development of regulations under the act.

 (12) Providing other services relating to the Department's administration of the act as assigned by the Department.

 (b) Minimum qualifications. The Commonwealth EMS Medical Director shall possess the same qualifications as a regional EMS medical director under § 1023.4 (relating to regional EMS medical director).

 (c) Disclosure. The Commonwealth EMS Medical Director shall disclose to the Department all financial or other interest in EMS agencies and other entities regulated by the Department and other matters which present a potential conflict of interest.

 (d) Prohibition against dual service. A physician may not simultaneously serve as the Commonwealth EMS Medical Director and a regional EMS medical director.

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Subchapter B. EMS PROVIDERS AND VEHICLE OPERATORS

Sec.

1023.21.	General rights and responsibilities.
1023.22.	EMS vehicle operator.
1023.23.	Ambulance attendant and first responder.
1023.24.	Emergency medical responder.
1023.25.	Emergency medical technician.
1023.26.	Advanced emergency medical technician.
1023.27.	Paramedic.
1023.28.	Prehospital physician extender.
1023.29.	Prehospital registered nurse.
1023.30.	Prehospital EMS physician.
1023.31.	Continuing education requirements.
1023.32.	Credit for continuing education.
1023.33.	Endorsement of course or examination.
1023.34.	Reciprocity.

§ 1023.21. General rights and responsibilities.

 (a) Change of address. An EMS provider, an EMSVO and an applicant for EMS provider or EMSVO certification shall ensure that the Department has a current address at which the person can be reached by mail. This applies to an EMS provider and an EMSVO whether or not that person maintains current registration of the EMS provider or EMSVO certification.

 (b) Reports of criminal convictions, discipline and exclusions.

 (1) An applicant for EMS provider or EMSVO certification shall report to the Department, on a form or through an electronic process, as prescribed by the Department, misdemeanor, felony and other criminal convictions that are not summary or equivalent offenses and disciplinary sanctions that have been imposed upon a license, certification or other authorization of the applicant to practice an occupation or profession. An applicant for an EMSVO certification shall also report to the Department any other conviction of an offense involving reckless driving or driving under the influence of alcohol or drugs. The applicant shall also arrange for the custodian of the criminal charging, judgment and sentencing document for each conviction and the custodian of an adjudication or other document imposing discipline against the applicant to provide the Department with a certified copy of those records. If the applicant has not been sentenced on a criminal conviction at the time of making application for certification, the applicant shall inform the Department and then arrange, within 5 days after the applicant is sentenced, for the custodian of the sentencing document to provide the Department with a certified copy of that document. If, after making application for EMS provider certification, but before the Department acts upon an application, the applicant is convicted of a reportable offense or has discipline imposed upon a license, certification or other authorization to practice an occupation or profession, the applicant shall report that information to the Department immediately in the manner prescribed in the application form.

 (2) An applicant for EMS provider certification shall report to the Department, on a form or through an electronic process, as prescribed by the Department, an exclusion from a Federal or State health care program of the applicant, or of an entity in which the applicant had equity or capital, stock or profits equal to at least 5% of the value of the property or assets of the entity at the time of the exclusion. The applicant shall also provide the Department with a certified copy of the document by which the applicant is excluded from the health care program. A health care program is a program in which the State or Federal government serves as a payor for health care services, such as the Medicare and Medicaid programs. If, after making application for EMS provider certification, but before the Department acts upon an application, there is an exclusion from a Federal or State health care program that is reportable under this paragraph, the applicant shall report that information to the Department immediately in the manner prescribed in the application form.

 (3) The Department will not act upon an application for certification that reports information under paragraph (1) or (2) until it receives a certified copy of each document that is required to be provided under those paragraphs, unless the applicant establishes that the document from which a certified copy would be made does not exist.

 (4) An EMS provider and an EMSVO shall report the same type of information and arrange for the same documents to be provided to the Department, as required under paragraphs (1) and (2), within 30 days after each conviction, discipline and exclusion. This applies to an EMS provider and an EMSVO whether or not the person maintains current registration of the EMS provider's or EMSVO's certification.

 (c) Certification examinations.

 (1) An applicant for EMS provider certification shall take the required certification examinations within 1 year after completing the education required for the EMS provider certification.

 (2) Except as otherwise provided in this section, a person who fails a written or practical skills certification examination may repeat the failed examination without retaking a passed certification examination.

 (3) A person who fails a written certification examination three times shall complete a refresher course approved by the Department or repeat the education required for the EMS provider certification before retaking a written certification examination.

 (4) A person who fails a practical skills certification examination three times shall complete a remedial course approved by the Department or repeat the education required for the EMS provider certification before retaking a practical skills certification examination.

 (5) A person who either fails an EMS provider certification examination six times or does not pass all required EMS provider certification examinations within 2 years after completing the EMS provider education required for the EMS provider certification may not receive credit for an examination previously passed. If that person elects to continue to pursue EMS provider certification, that person will be required to repeat the EMS provider education program and take the EMS provider certification examinations in accordance with paragraphs (1)—(4).

 (d) Exceptions to certification registration requirements for members of armed forces. An EMS provider or EMSVO who returns from active military service and who had a certification registration expire during a tour of duty or will have a certification registration expire within 12 months after returning from active military service may secure an exception to the certification registration requirements as follows:

 (1) An EMS provider who chooses to secure registration of the EMS provider's certification by satisfying continuing education requirements may apply for an exception to the period of time in which the EMS provider was required or would be required to satisfy the continuing education requirements, and the Department will grant the EMS provider an extended period of time to satisfy those requirements as the Department deems appropriate under the circumstances. If the EMS provider is certified at an AEMT level or higher, before the EMS provider may begin work for an EMS agency without a current registration, the EMS provider needs to be approved by the EMS agency's medical director, under § 1023.1(a)(1)(viii) (relating to EMS agency medical director) as having current competency in the knowledge and skills required to provide the level of EMS the EMS agency intends to assign to the EMS provider.

 (2) An EMS provider who chooses to secure registration of the EMS provider's certification by satisfying continuing education requirements may ask the Department to endorse the EMS provider's relevant military training as satisfying some or all of the continuing education requirements.

 (3) An EMSVO may apply for an exception to the period of time in which the EMSVO was required or would be required to satisfy the continuing education requirements, and the Department will grant the EMSVO an extended period of time to satisfy those requirements as the Department deems appropriate under the circumstances. An EMSVO may also ask the Department to endorse the EMSVO's relevant military training as satisfying some or all of the continuing education requirements.

 (e) Lapse of registration.

 (1) An EMS provider who does not secure a new registration of an EMS provider certification before a registration expires may secure a new registration within 2 years after the registration expires by completing a registration form or through an electronic process, as prescribed by the Department, if the information provided establishes that the EMS provider has passed the written certification registration examination as well as the clinical patient care and other core continuing education requirements that would have been needed to timely secure the registration by satisfying the continuing education requirements for registering the certification.

 (2) An EMS provider who does not secure a new registration of an EMS provider certification before a registration expires may secure a new registration later than 2 years after the registration expires by completing a registration form or through an electronic process, as prescribed by the Department, if the information provided establishes that the EMS provider has passed both the written and practical skills certification registration examinations and the clinical patient care and other core continuing education requirements for each registration of a certification that was missed.

 (3) The paramedic certification registration examinations are the certification registration examinations for a PHPE, a PHRN and a PHP who seeks to register a certification after the registration of that certification lapses.

 (4) A registration secured under this subsection will expire when the registration would have expired if past registrations would have been secured on a timely basis.

 (f) Authority derived from protocols and medical command orders. An EMS provider shall provide EMS for an EMS agency within the EMS provider's scope of practice and, other than a PHP, under Statewide and regional EMS protocols and medical command orders.

 (g) Downgraded certification or practice. An EMS provider who is certified at or above the AEMT level who chooses not to practice at that level or who is not permitted to practice at that level for an EMS agency by its EMS agency medical director under § 1023.1(a)(1)(vi) or (vii) and § 1027.3(n) (relating to licensure and general operating standards), has the following options with respect to EMS provider certification and registration of that certification:

 (1) Upon expiration of the biennial registration period, the EMS provider may choose to maintain EMS provider certification at the EMS provider's current certification level, in which case the EMS provider would need to satisfy the requirements for the registration of that EMS provider certification to renew registration of that certification.

 (2) Prior to or upon expiration of the registration period, the EMS provider may choose to transition to a lower level EMS provider certification than the EMS provider's current certification level, in which case the EMS provider would need to satisfy the requirements for the registration of that EMS provider certification to secure registration of that lower level EMS provider certification. If the EMS provider satisfies the registration requirements for that lower level of EMS provider certification, the Department will issue the EMS provider an EMS provider certification at that level, which will be deemed registered for 3 years or 2 years, depending upon the level of certification.

 (3) When providing EMS, an EMS provider who transitions to a lower level EMS provider certification may not display a higher level insignia, patch, registration card or other indicia of the EMS provider's certification at the higher EMS provider level.

 (4) An EMS provider who, for any period of time, has been precluded from practicing for an EMS agency at the EMS provider's certification level under § 1027.3(n) shall report the action to other EMS agencies for which the EMS provider is providing or seeks to provide EMS and to all regional EMS councils having responsibility for the EMS regions in which those EMS agencies are headquartered.

 (5) An EMS provider who transitions to a lower level EMS provider certification may later renew registration of the EMS provider's certification at the higher level by satisfying the requirements in subsection (e).

 (h) Identification. If an EMS provider is asked to provide proof of authority to practice as an EMS provider when the EMS provider is providing EMS, or an EMSVO is asked to provide proof of authority to operate an EMS vehicle when the EMSVO is operating an EMS vehicle, the EMS provider or EMSVO shall present a card or certificate issued by the Department that shows current registration of the EMS provider's or EMSVO's certification.

 (i) Interaction with law enforcement officers.

 (1) If a law enforcement officer is at the scene of a police incident when an EMS provider arrives, the EMS provider may not enter the scene to provide EMS if the law enforcement officer so directs until the law enforcement officer advises that it is safe for the EMS provider to enter.

 (2) An EMS provider shall have access to a patient at a police incident scene before the patient is removed from the scene by or at the direction of a law enforcement officer.

 (3) If, under a medical treatment protocol or a medical command order, an EMS provider is required to transport to a receiving facility a patient whom a law enforcement officer has taken or wants to take into custody or whom the law enforcement officer believes needs to be spoken to immediately by the law enforcement officer, the EMS provider shall transport the patient to a receiving facility by ambulance. The EMS provider and EMSVO shall allow the law enforcement officer to accompany the patient in the ambulance if the law enforcement officer so chooses and may not interfere with the law enforcement officer employing security precautions deemed necessary by the law enforcement officer to ensure the safety of the officer and others. A law enforcement officer is not permitted to implement security precautions that unreasonably interfere with the provision of EMS to the patient.

§ 1023.22. EMS vehicle operator.

 (a) Roles and responsibilities. An EMSVO operates ground EMS vehicles for an EMS agency, as authorized by an EMS agency.

 (b) Certification. The Department will certify as an EMSVO an individual who meets the following qualifications:

 (1) Completes an application for EMSVO certification on a form or through an electronic process, as prescribed by the Department.

 (2) Is 18 years of age or older.

 (3) Has a current driver's license.

 (4) Is not addicted to alcohol or drugs.

 (5) Is free from physical or mental defect or disease that may impair the person's ability to drive a ground EMS vehicle.

 (6) Has successfully completed an emergency vehicle operator's course of instruction approved by the Department.

 (7) Has not:

 (i) Been convicted within the last 4 years prior to the date of application of driving under the influence of alcohol or drugs.

 (ii) Within the last 2 years prior to the date of application been convicted of reckless driving or had a driver's license suspended due to use of drugs or alcohol or a moving traffic violation.

 (8) Has successfully completed an EVOC following a disqualification from certification under paragraph (7), regardless of whether the person successfully completed the course previously.

 (c) Transition for operators of ground ambulances and squad vehicles. A person who drove an ambulance or squad vehicle prior to ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) and who satisfies the certification requirements under subsection (b), may serve as an EMSVO until ______ , (Editor's Note: The blank refers to 90 days after the effective date of adoption of this proposed rulemaking.) without having secured a certification as an EMSVO.

 (d) Registration.

 (1) Except as otherwise provided in this subsection, an EMSVO's certification is deemed registered for 3 years. Thereafter, an EMSVO shall triennially register the certification by completing a form or through an electronic process, as prescribed by the Department. An EMSVO shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMSVO certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the EMSVO completes the form or the electronic process if the information provided establishes that the EMSVO has a current driver's license and has successfully completed the continuing education requirements for registration of an EMSVO certification in § 1023.31(a) (relating to continuing education requirements).

 (2) If an EMSVO also has an EMS provider's certification, the registration of the EMSVO's certification will expire at the same time as the registration of the EMS provider's certification. If the EMSVO does not maintain current registration of the EMS provider's certification, the registration of the EMSVO's certification will continue on the same renewal cycle. If an EMSVO who is an EMS provider becomes certified as a higher-level EMS provider, the registration of the EMSVO's certification will expire at the same time as the registration of the higher-level EMS provider's certification.

 (3) An EMSVO who does not secure a new registration of an EMSVO certification later than 2 years after the registration expires may secure a new registration by completing a registration form or through an electronic process, as prescribed by the Department, if the information provided establishes that the EMSVO has completed the continuing education requirements for that registration period and an EVOC within the preceding 2 years.

 (4) An EMSVO who is a member of the armed forces who is returning from active military service and whose EMSVO registration has expired or will expire within 12 months after returning from active military service may secure an exception to the registration requirements under § 1023.21(d) (relating to general rights and responsibilities).

 (5) An EMSVO who operates an EMS vehicle exclusively for a QRS operated by an EMS agency does not have registration requirements.

§ 1023.23. Ambulance attendant and first responder.

 An individual who is an ambulance attendant or who is certified as a first responder on ______ , (Editor's Note: The blank refers to 180 days after adoption of this proposed rulemaking.) will be deemed to be an EMR with a current registration and shall thereafter be subject to § 1023.24 (relating to emergency medical responder). The Department will issue an EMR certification to an individual who is certified as a first responder on ______ (Editor's Note: The blank refers to 180 days after adoption of this proposed rulemaking.). The Department will issue an EMR certification to an individual who is qualified as an ambulance attendant on ______ , (Editor's Note: The blank refers to 180 days after adoption of this proposed rulemaking.) if that individual submits an application for EMR certification on a form or through an electronic process, as prescribed by the Department, which documents that the individual was qualified as an ambulance attendant under rescinded § 1003.21(b). An individual who qualifies for EMR certification by virtue of having been an ambulance attendant may serve as an EMR until ______ , (Editor's Note: The blank refers to 2 years after the effective date of section 8133 of the act. Section 8133 of the act is effective 180 days after adoption of this proposed rulemaking.) without having obtained an EMR certification. The initial registration of an EMR certification of a person who qualified for that certification by having been a first responder will expire when that person's first responder certification would have expired. The initial registration of an EMR certification of a person who qualified for that certification by having been an ambulance attendant will expire when that person's qualifications as an ambulance attendant would have expired.

§ 1023.24. Emergency medical responder.

 (a) Roles and responsibilities. An EMR performs for an EMS agency BLS skills involving basic interventions with minimum EMS equipment as follows:

 (1) As a member of a QRS to stabilize and improve a patient's condition until a higher level EMS provider arrives at the scene. The EMR may then assist the higher level EMS provider if requested to do so.

 (2) As a member of the crew of an ambulance or squad vehicle.

 (3) As a member of a special operations EMS service.

 (b) Certification.

 (1) The Department will certify as an EMR an individual who meets the following qualifications:

 (i) Completes an application for EMR certification on a form or through an electronic process, as prescribed by the Department.

 (ii) Is 16 years of age or older.

 (iii) Has successfully completed an EMS provider educational course for EMRs or by ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) a first responder educational course previously approved by the Department as an educational course leading to first responder certification.

 (iv) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (v) Has passed a written examination for EMR certification prescribed by the Department or passed an examination which the Department has determined to be equivalent in both content and manner of administration to the written examination for EMR certification.

 (vi) Has passed a practical test of EMR skills for EMR certification prescribed by the Department or passed an examination which the Department has determined to be equivalent in both content and manner of administration to the practical test of EMR skills for EMR certification.

 (2) The Department will also certify as an EMR an individual who completes an application on a form or through an electronic process, as prescribed by the Department, and who applies for EMR certification under § 1023.21(g) (relating to general rights and responsibilities).

 (c) Triennial registration.

 (1) An EMR's certification is deemed registered for 3 years. Thereafter, an EMR shall triennially register the certification by completing a form or through an electronic process, as prescribed by the Department. An EMR shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMR certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the EMR completes the form or the electronic process if the information provided establishes that the EMR has successfully completed one of the following:

 (i) The EMR practical skills and written knowledge triennial registration examinations prescribed by the Department.

 (ii) The continuing education requirements for triennial registration of an EMR certification in § 1023.31(b) (relating to continuing education requirements).

 (2) An EMR who is a member of the armed forces who is returning from active military service and whose EMR registration has expired or will expire within 12 months after returning from active military service may secure an exception to the triennial registration requirements under § 1023.21(d).

 (d) Scope of practice.

 (1) An EMR's scope of practice includes skills in the following skill areas, as published in the Pennsylvania Bulletin, if the EMR has been educated to perform the following skills:

 (i) Airway/ventilation/oxygenation.

 (ii) Cardiovascular circulation.

 (iii) Immobilization.

 (2) An EMR's scope of practice may be expanded to include BLS skills in other skill areas as the Department publishes in a notice in the Pennsylvania Bulletin. An EMR may not perform those additional skills unless the EMR has received education to perform those skills and is able to document having received the education in one of the following:

 (i) A course approved by the Department that covers the complete curriculum for certification as an EMR.

 (ii) A course which is determined by the Department to meet or exceed the standards of a course approved by the Department under subparagraph (i).

 (iii) A course for which the EMR may receive continuing education credit towards triennial registration of the EMR's certification or, if the EMR was previously certified as a first responder, a course for which the EMR received continuing education credit towards first responder recertification prior to ______ (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.).

 (3) The Department will publish in the Pennsylvania Bulletin, at least biennially, a list of the skills the Department has approved as being within the scope of practice of an EMR.

§ 1023.25. Emergency medical technician.

 (a) Roles and responsibilities. An EMT performs basic EMS skills involving basic interventions and equipment found on an EMS vehicle or within an EMT's scope of practice as follows:

 (1) For an EMS agency as a member of the crew of an ambulance or squad vehicle.

 (2) For an EMS agency as a member of a QRS to stabilize and improve a patient's condition in an out-of-hospital setting until an ambulance arrives. The EMT may then assist the ambulance crew.

 (3) As a member of a special operations EMS service.

 (4) As a first aid or safety officer, or in a similar capacity, for or independent of an EMS agency. When serving in this capacity independent of an EMS agency, the EMT does not function under the direction of an EMS agency medical director or a medical command physician. The EMT shall perform skills as prescribed by applicable Statewide and regional EMS protocols and may not perform any skill for which the EMT is required to secure medical command direction under those protocols.

 (b) Certification.

 (1) The Department will certify as an EMT an individual who meets the following qualifications:

 (i) Completes an application for EMT certification on a form or through an electronic process, as prescribed by the Department.

 (ii) Is 16 years of age or older.

 (iii) Has successfully completed an EMS provider educational course for EMTs.

 (iv) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (v) Has passed a written examination for EMT certification prescribed by the Department.

 (vi) Has passed a practical test of EMT skills for EMT certification prescribed by the Department.

 (2) The Department will also certify as an EMT an individual who completes an application on a form or through an electronic process, as prescribed by the Department and who applies for EMT certification under § 1023.21(g) (relating to general rights and responsibilities).

 (c) Triennial registration.

 (1) An EMT's certification is deemed registered for 3 years. Thereafter, an EMT shall triennially register the certification by completing a form or through an electronic process, as prescribed by the Department. An EMT shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMT certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the EMT completes the form or the electronic process if the information provided establishes that the EMT has successfully completed one of the following:

 (i) The EMT practical skills and written knowledge triennial registration examinations prescribed by the Department.

 (ii) The continuing education requirements for triennial registration of an EMT certification in § 1023.31(c) (relating to continuing education requirements).

 (2) An EMT who is a member of the armed forces who is returning from active military service and whose EMT registration has expired or will expire within 12 months after returning from active military service may secure an exception to the triennial registration requirements under § 1023.21(d).

 (d) Scope of practice.

 (1) An EMT's scope of practice incorporates the scope of practice of an EMR and additional skills in the following skill areas, as published in the Pennsylvania Bulletin, if the EMT has been educated to perform the following skills:

 (i) Airway/ventilation/oxygenation.

 (ii) Cardiovascular circulation.

 (iii) Immobilization.

 (iv) Medication administration—routes.

 (2) An EMT's scope of practice may be expanded to include basic EMS skills in other skill areas as the Department publishes in a notice in the Pennsylvania Bulletin. An EMT may not perform those additional skills unless the EMT has received education to perform those skills, and is able to document having received the education, in one of the following:

 (i) A course approved by the Department that covers the complete curriculum for certification as an EMT.

 (ii) A course which is determined by the Department to meet or exceed the standards of course approved by the Department under subparagraph (i).

 (iii) A course for which the EMT may receive continuing education credit towards recertification.

 (3) The Department will publish in the Pennsylvania Bulletin, at least biennially, a list of the skills the Department has approved as being within the scope of practice of an EMT.

§ 1023.26. Advanced emergency medical technician.

 (a) Roles and responsibilities. An AEMT performs basic and advanced EMS skills which include interventions and administration of medications and vaccines with basic and advanced equipment found on an EMS vehicle or within an AEMT's scope of practice, as follows:

 (1) For an EMS agency as a member of the crew of an ambulance or squad vehicle.

 (2) For an EMS agency as a member of a QRS to stabilize and improve a patient's condition in an out-of-hospital setting until an ambulance arrives. The AEMT may then assist the ambulance crew.

 (3) As a member of a special operations EMS service.

 (4) As a first aid or safety officer, or in a similar capacity, for or independent of an EMS agency. When serving in this capacity independent of an EMS agency, an AEMT does not function under the direction of an EMS agency medical director or a medical command physician. The AEMT shall perform skills as prescribed by applicable Statewide and regional EMS protocols and may not perform the following:

 (i) Skills other than those permitted at the EMT level of care.

 (ii) A skill for which the EMT is required to secure medical command direction under those protocols.

 (b) Certification

 (1) The Department will certify as an AEMT an individual who meets the following qualifications:

 (i) Completes an application for AEMT certification on a form or through an electronic process, as prescribed by the Department.

 (ii) Is 18 years of age or older.

 (iii) Has successfully completed one of the following:

 (A) An EMS provider educational course for AEMTs.

 (B) An EMS provider educational course for EMTs and education, through continuing education courses, in skills required in the scope of practice of an AEMT for which the applicant did not receive education in the EMT course.

 (iv) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (v) Has passed a written examination for AEMT certification prescribed by the Department.

 (vi) Has passed a practical test of AEMT skills for AEMT certification prescribed by the Department.

 (2) The Department will also certify as an AEMT an individual who completes an application on a form or through an electronic process, as prescribed by the Department and who applies for AEMT certification under § 1023.21(g) (relating to general rights and responsibilities).

 (c) Biennial registration.

 (1) When an AEMT certification is issued it is deemed registered through December 31 of that year if it is issued in an odd-numbered year, or through December 31 of the next odd-numbered year if it is issued in an even-numbered year. Thereafter, an AEMT shall biennially register the certification by completing a form or through an electronic process, as prescribed by the Department. An AEMT shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the AEMT certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the AEMT completes the form or the electronic process if the information provided establishes that the AEMT has successfully completed one of the following:

 (i) The AEMT practical skills and written knowledge biennial registration examinations prescribed by the Department.

 (ii) The continuing education requirements for biennial registration of an AEMT certification in § 1023.31(d) (relating to continuing education requirements).

 (2) An AEMT who is a member of the armed forces who is returning from active military service and whose AEMT registration has expired or will expire within 12 months after returning from active military service may secure an exception to the biennial registration requirements under § 1023.21(d).

 (d) Scope of practice.

 (1) An AEMT's scope of practice incorporates the scope of practice of an EMT and additional skills in the following skill areas, as published in the Pennsylvania Bulletin, if the AEMT has been educated to perform the following skills:

 (i) Airway/ventilation/oxygenation.

 (ii) Cardiovascular circulation.

 (iii) Immobilization.

 (iv) Medication administration—routes.

 (v) IV initiation/maintenance fluids.

 (2) An AEMT's scope of practice may be expanded to include ALS skills in other skill areas as the Department publishes in a notice in the Pennsylvania Bulletin. An AEMT may not perform those additional skills unless the AEMT has received education to perform those skills and is able to document having received the education in one of the following:

 (i) A course approved by the Department that covers the complete curriculum for an AEMT.

 (ii) A course which is determined by the Department to meet or exceed the standards of a course approved by the Department under subparagraph (i).

 (iii) A course for which an AEMT may receive continuing education credit towards biennial registration of the AEMT certification.

 (3) The Department will publish in the Pennsylvania Bulletin, at least biennially, a list of the skills the Department has approved as being within the scope of practice of an AEMT.

§ 1023.27. Paramedic.

 (a) Roles and responsibilities. A paramedic performs basic and advanced EMS skills which include interventions and administration of medications and vaccines with basic and advanced equipment found on an EMS vehicle found or within a paramedic's scope of practice, as follows:

 (1) For an EMS agency as a member of the crew of an ambulance or squad vehicle.

 (2) For an EMS agency as a member of a QRS to stabilize and improve a patient's condition in an out-of-hospital emergency until an ambulance arrives at the scene. The paramedic may then assist the ambulance crew.

 (3) As a member of a special operations EMS service.

 (4) As a first aid or safety officer, or in a similar capacity, for or independent of an EMS agency. When serving in this capacity independent of an EMS agency, a paramedic does not function under the direction of an EMS agency medical director or a medical command physician. The paramedic shall perform skills as prescribed by applicable Statewide and regional EMS protocols, and may not perform the following:

 (i) Skills other than those permitted at the EMT level of care.

 (ii) A skill for which the EMT is required to secure medical command direction under those protocols.

 (b) Certification. The Department will certify as a paramedic an individual who meets the following qualifications:

 (1) Completes an application for paramedic certification on a form or through an electronic process, as prescribed by the Department.

 (2) Is certified as an EMT or an AEMT by the Department or possesses an equivalent certification issued by another state.

 (3) Is 18 years of age or older.

 (4) Has a high school diploma or its equivalent.

 (5) Has successfully completed an EMS provider educational course for paramedics.

 (6) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (7) Has passed a practical test of paramedic skills for paramedic certification approved by the Department.

 (8) Has passed a written examination for paramedic certification approved by the Department.

 (c) Biennial registration.

 (1) When a paramedic certification is issued it is deemed registered through December 31 of that year if it is issued in an odd-numbered year, or through December 31 of the next odd-numbered year if it is issued in an even-numbered year. Thereafter, a paramedic shall biennially register the certification by completing a form or through an electronic process, as prescribed by the Department. A paramedic shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the paramedic certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the paramedic completes the form or the electronic process if the information provided establishes that the paramedic has successfully completed one of the following:

 (i) The paramedic practical skills and written knowledge biennial registration examinations prescribed by the Department.

 (ii) The continuing education requirements for biennial registration of a paramedic certification in § 1023.31(e) (relating to continuing education requirements).

 (2) A paramedic who is a member of the armed forces who is returning from active military service and whose paramedic registration has expired or will expire within 12 months after returning from active military service may secure an exception to the triennial registration requirements under § 1023.21(d) (relating to general rights and responsibilities).

 (d) Scope of practice.

 (1) A paramedic's scope of practice incorporates the scope of practice of an AEMT and additional skills in the following skill areas, as published in the Pennsylvania Bulletin, if the paramedic has been educated to perform the following skills:

 (i) Airway/ventilation/oxygenation.

 (ii) Cardiovascular circulation.

 (iii) Immobilization.

 (iv) Medication administration—routes.

 (v) IV initiation/maintenance fluids.

 (2) A paramedic's scope of practice may be expanded to include advanced EMS skills in other skill areas as the Department publishes in a notice in the Pennsylvania Bulletin. A paramedic may not perform those additional skills unless the paramedic has received education to perform those skills, and is able to document having received the education, in one of the following:

 (i) A course approved by the Department that covers the complete curriculum for certification as a paramedic.

 (ii) A course which is determined by the Department to meet or exceed the standards of a course approved by the Department under subparagraph (i).

 (iii) A course for which the paramedic may receive continuing education credit towards biennial registration of the paramedic certification.

 (3) The Department will publish in the Pennsylvania Bulletin, at least biennially, a list of the skills the Department has approved as being within the scope of practice of a paramedic.

§ 1023.28. Prehospital physician extender.

 (a) Roles and responsibilities. A PHPE performs for an EMS agency basic and advanced EMS skills, and additional skills within the scope of practice of a physician assistant under the Medical Practice Act of 1985 (63 P. S. §§ 422.1—422.51a) or the Osteopathic Medical Practice Act (63 P. S. §§ 271.1—271.18), or a successor act, as follows:

 (1) As a member of the crew of an ambulance or squad vehicle.

 (2) As a member of a QRS to stabilize and improve a patient's condition in an out-of-hospital emergency until an ambulance arrives at the scene. The PHPE may then assist the ambulance crew.

 (3) As a member of a special operations EMS service.

 (4) As a first aid or safety officer, or in a similar capacity.

 (b) Certification. The Department will certify as a PHPE an individual who meets the following qualifications:

 (1) Completes an application for PHPE certification on a form or through an electronic process, as prescribed by the Department.

 (2) Has a currently registered license as a physician assistant with the State Board of Medicine or the State Board of Osteopathic Medicine.

 (3) Is 18 years of age or older.

 (4) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (5) Has passed a practical test of PHPE skills for PHPE certification approved by the Department.

 (6) Has passed a written test of PHPE skills for PHPE certification approved by the Department.

 (c) Biennial registration.

 (1) When a PHPE certification is issued it is deemed registered through December 31 of that year, if it is issued in an odd-numbered year, or through December 31 of the next odd-numbered year, if it is issued in an even-numbered year. Thereafter, a PHPE shall biennially register the certification by completing a form or through an electronic process, as prescribed by the Department. A PHPE shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the PHPE certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the PHPE completes the form or the electronic process if the information provided establishes that the PHPE has satisfied the following:

 (i) Has a current physician assistant license or current registration of that license.

 (ii) Has completed the continuing education requirements for biennial registration of a PHPE certification in § 1023.31(f) (relating to continuing education requirements).

 (2) A PHPE who is a member of the armed forces who is returning from active military service and whose PHPE registration has expired or will expire within 12 months after returning from active military service may secure an exception to the biennial registration requirements under § 1023.21(d) (relating to general rights and responsibilities).

 (d) Scope of practice. A PHPE may perform skills within a paramedic's scope of practice and other skills a physician assistant is authorized to perform by the Medical Practice Act of 1985 or the Osteopathic Medical Practice Act, whichever applies to the physician assistant, when authorized by a medical command physician or an applicable Statewide or Department-approved EMS protocol. When a PHPE functions in this capacity, the physician supervision requirements under the Medical Practice Act of 1985 and the Osteopathic Medical Practice Act do not apply. A PHPE who has not been educated in a skill within a paramedic's scope of practice may not perform that skill unless and until the PHPE has received education to perform the skill and is able to document having received the education as required under § 1023.27(d)(2) (relating to paramedic) or otherwise documents having received the education to competently perform the skill.

§ 1023.29. Prehospital registered nurse.

 (a) Roles and responsibilities. A PHRN performs for an EMS agency basic and advanced EMS skills and additional skills within the scope of practice of a registered nurse under The Professional Nursing Law (63 P. S. §§ 211—225.5) as follows:

 (1) As a member of the crew of an ambulance or squad vehicle.

 (2) As a member of a QRS to stabilize and improve a patient's condition in an out-of-hospital emergency until an ambulance arrives at the scene. The PHRN may then assist the ambulance crew.

 (3) As a member of a special operations EMS service.

 (4) As a first aid or safety officer, or in a similar capacity.

 (b) Certification. The Department will certify as a PHRN an individual who meets the following qualifications:

 (1) Completes an application for PHRN certification on a form or through an electronic process, as prescribed by the Department.

 (2) Has a current license as a registered nurse with the State Board of Nursing.

 (3) Is 18 years of age or older.

 (4) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (5) Has passed a practical test of PHRN skills for PHRN certification approved by the Department.

 (6) Has passed a written test of PHRN skills for PHRN certification approved by the Department.

 (c) Biennial registration.

 (1) When a PHRN certification is issued it is deemed registered through December 31 of that year, if it is issued in an odd-numbered year, or through December 31 of the next odd-numbered year, if it is issued in an even-numbered year. Thereafter, a PHRN shall biennially register the certification by completing a form or through an electronic process, as prescribed by the Department. A PHRN shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the PHRN certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the PHRN completes the form or the electronic process if the information provided establishes that the PHRN has satisfied the following:

 (i) Has a current registered nurse license or current registration of that license.

 (ii) Has completed the continuing education requirements for biennial registration of a PHRN certification in § 1023.31(g) (relating to continuing education requirements).

 (2) A PHRN who is a member of the armed forces who is returning from active military service and whose PHRN registration has expired or will expire within 12 months after returning from active military service may secure an exception to the biennial registration requirements under § 1023.21(d) (relating to general rights and responsibilities).

 (d) Scope of practice. A PHRN may perform skills within a paramedic's scope of practice and other skills authorized by The Professional Nursing Law, when authorized by a medical command physician or the applicable Statewide or Department-approved EMS protocol. A PHRN who has not been educated in a skill within a paramedic's scope of practice may not perform that skill unless and until the PHRN has received education to perform the skill and is able to document having received the education as required under § 1023.27(d)(2) (relating to paramedic) or otherwise documents having received the education to competently perform the skill.

§ 1023.30. Prehospital EMS physician.

 (a) Roles and responsibilities. A PHP performs for an EMS agency basic and advanced EMS skills within the scope of practice of a physician under the Medical Practice Act of 1985 (63 P. S. §§ 422.1—422.51a) or the Osteopathic Medical Practice Act (63 P. S. §§ 271.1—271.18) as follows:

 (1) As a member of the crew of an ambulance or squad vehicle.

 (2) As a member of a QRS to stabilize and improve a patient's condition in an out-of-hospital setting.

 (3) As a member of a special operations EMS service.

 (4) As a first aid or safety officer, or in a similar capacity.

 (b) Certification. The Department will certify as PHP a physician who meets the following qualifications:

 (1) Completes an application for PHP certification on a form or through an electronic process, as prescribed by the Department.

 (2) Has successfully completed one of the following:

 (i) A residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.

 (ii) The first year of a residency program that satisfies the requirements in subparagraph (i) and the ACLS course, the ATLS course, the APLS or PALS course or, for each of these courses, a course that the Department determines meets or exceeds the requirements of the course.

 (iii) A residency program in anesthesia, general surgery, internal medicine or family medicine, by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine, and the ACLS course, the ATLS course, the APLS or PALS course or, for each of these courses, a course that the Department determines meets or exceeds the requirements of the course.

 (3) Has a current certificate evidencing successful completion of a CPR course acceptable to the Department.

 (4) Has passed a practical test of EMS skills prescribed by the Department for a PHP or served as a prehospital health professional physician prior to ______ (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.).

 (c) Transition for prehospital health professional physicians. A physician who served as a prehospital health professional physician prior to ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) and who satisfies the certification requirements under subsection (b)(2), may serve as a PHP until ______ , (Editor's Note: The blank refers to 90 days after the effective date of adoption of this proposed rulemaking.) without having secured a certification as a PHP.

 (d) Biennial registration.

 (1) When a PHP certification is issued it is deemed registered through December 31 of that year, if it is issued in an odd-numbered year, or through December 31 of the next odd-numbered year, if it is issued in an even-numbered year. Thereafter, a PHP shall biennially register the certification by completing a form or through an electronic process, as prescribed by the Department. A PHP shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the PHP certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the PHP completes the form or the electronic process if the information provided establishes that the PHP has satisfied the following:

 (i) Has a current physician license or current registration of that license.

 (ii) Has completed the continuing education requirements for biennial registration of a PHP certification in § 1023.31(h) (relating to continuing education requirements).

 (2) A PHP who is a member of the armed forces who is returning from active military service and whose PHP registration has expired or will expire within 12 months after returning from active military service may secure an exception to the biennial registration requirements under § 1023.21(d) (relating to general rights and responsibilities).

 (e) Scope of practice. A PHP may perform skills within a paramedic's scope of practice and other skills within the practice of medicine or osteopathic medicine. A PHP may not perform a skill that the PHP has not been educated to perform. A regional EMS medical director shall verify that a PHP who is also an EMS agency medical director and who qualifies for PHP certification by satisfying the requirements in subsection (b)(2)(iii) has the competency to perform all skills within a paramedic's scope of practice.

§ 1023.31. Continuing education requirements.

 (a) EMS vehicle operators. Beginning with the first full registration period an EMSVO begins follow- ing ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) an EMSVO whose certification is currently registered shall, prior to the expiration of the registration period, successfully complete three continuing education credits if the registration is on a 3-year renewal cycle and two continuing education credits if the registration is on a 2-year renewal cycle, as specified in a notice the Department publishes in the Pennsylvania Bulletin. The continuing education requirements imposed by this subsection for registration of an EMSVO certification are in addition to those imposed upon an EMS provider for registration of an EMS provider certification.

 (b) EMRs. Beginning with the first full registration period an EMR begins following ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) an EMR whose certification is currently registered and who elects to qualify for triennial registration of the certification by fulfilling continuing education requirements shall, prior to the expiration of the 3-year registration period, successfully complete the following:

 (1) Sixteen credits in instruction in subjects related to the scope of practice of an EMR as set forth in § 1023.24(a) and (d) (relating to emergency medical responder) and which have been approved by the Department for continuing education credit. At least 12 of the credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin. During an initial registration period that goes into effect on ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) an EMR who has transitioned from a first responder certification to an EMR certification shall satisfy the continuing education requirements that had been imposed upon a first responder under rescinded § 1003.29(a) to renew a first responder certification.

 (2) A CPR course completed or taught biennially.

 (c) EMTs. Beginning with the first full registration period an EMT begins following ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) an EMT whose certification is currently registered and who elects to qualify for triennial registration of the certification by fulfilling continuing education requirements shall, prior to the expiration of the 3-year registration period, successfully complete the following:

 (1) Twenty-four credits in instruction in subjects related to the scope of practice of an EMT as set forth in § 1023.25(a) and (d) (relating to emergency medical technician) and which have been approved by the Department for continuing education credit. At least 18 of the credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin. During an initial registration period that goes into effect on ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) an EMT shall satisfy the continuing education requirements that had been imposed upon an EMT under rescinded § 1003.29(b) to renew an EMT certification.

 (2) A CPR course completed or taught biennially.

 (d) AEMTs. An AEMT whose certification is currently registered and who elects to qualify for biennial registration of the certification by fulfilling continuing education requirements shall, prior to the expiration of the 2-year registration period, successfully complete the following:

 (1) Effective with the registration period beginning January 1, 2014, 36 credits in instruction in subjects related to the scope of practice of an AEMT as set forth in § 1023.26(a) and (d) (relating to advanced emergency medical technician) and which have been approved by the Department for continuing education credit. At least 27 of the credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin, beginning with the first full registration period the AEMT begins following the initial registration period. The continuing education requirements to register an AEMT certification for a second registration period shall be prorated based upon the month the certification was secured, with a fractional requirement rounded down.

 (2) A CPR course completed or taught biennially.

 (e) Paramedics. A paramedic whose certification is currently registered and who elects to qualify for biennial registration of the certification by fulfilling continuing education requirements shall, prior to the expiration of the 2-year registration period, successfully complete the following:

 (1) Effective with the registration period beginning January 1, 2014, 36 credits in instruction in subjects related to the scope of practice of a paramedic as set forth in § 1023.27(a) and (d) (relating to paramedic) and which have been approved by the Department for continuing education credit. At least 27 of the credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin, beginning with the first full registration period the paramedic begins following the initial registration period. The continuing education requirements to register a paramedic certification for a second registration period shall be prorated based upon the month the certification was secured, with a fractional requirement rounded down.

 (2) A CPR course completed or taught biennially.

 (3) Prior to January 1, 2014, a paramedic shall satisfy the continuing education requirements that had been imposed upon a paramedic under rescinded § 1003.29(c) to renew medical command authorization.

 (f) PHPEs. A PHPE whose certification is currently registered shall, prior to the expiration of the 2-year registration period, successfully complete the following:

 (1) Effective with the registration period beginning January 1, 2014, 36 credits in instruction in subjects related to the scope of practice of a PHPE as set forth in § 1023.28(a) and (d) (relating to prehospital physician extender) and which have been approved by the Department for continuing education credit. At least 27 of the credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin. The continuing education requirements to register a PHPE certification for a second registration period shall be prorated based upon the month the certification was secured, with a fractional requirement rounded down.

 (2) A CPR course completed or taught biennially.

 (3) Prior to January 1, 2014, a PHPE shall satisfy the continuing education requirements that had been imposed upon a paramedic under rescinded § 1003.29(c) to renew medical command authorization.

 (g) Prehospital registered nurses. A PHRN whose certification is currently registered shall, prior to the expiration of the 2-year registration period, successfully complete the following:

 (1) Effective with the registration period beginning January 1, 2014, 36 credits in instruction in subjects related to the scope of practice of a PHRN as set forth in § 1023.29(a) and (d) (relating to prehospital registered nurse) and which have been approved by the Department for continuing education credit. At least 27 of those credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin. The continuing education requirements to register a PHRN certification for a second registration period shall be prorated based upon the month the certification was secured, with a fractional requirement rounded down.

 (2) A CPR course completed or taught biennially.

 (3) Prior to January 1, 2014, a PHRN shall satisfy the continuing education requirements that had been imposed upon a PHRN under rescinded § 1003.29(d) to renew medical command authorization.

 (h) PHPs. A PHP whose certification is currently registered shall, prior to the expiration of the 2-year registration period, successfully complete the following:

 (1) Effective with the registration period beginning January 1, 2014, 36 credits in instruction in subjects related to the scope of practice of a PHP as set forth in § 1023.30(a) and (e) (relating to prehospital EMS physician) and which have been approved by the Department for continuing education credit. At least 27 of the credits shall be in clinical patient care and other core continuing education courses as specified in a notice the Department publishes in the Pennsylvania Bulletin. The continuing education requirements to register a PHP certification for a second registration period shall be prorated based upon the month the certification was secured, with a fractional requirement rounded down.

 (2) A CPR course completed or taught biennially.

 (i) Conditional continuing education requirements. This section does not prohibit an EMS agency from requiring EMS providers or EMSVO to satisfy continuing education requirements it may choose to impose as a condition of employment, provided that the EMS agency may not excuse an EMS provider or EMSVO from meeting continuing education requirements imposed by this section.

§ 1023.32. Credit for continuing education.

 (a) Credit. An EMS provider and an EMSVO shall receive one credit for each 60 minutes of instruction approved by the Department for continuing education credit presented in a classroom setting by a continuing education sponsor. Credit may not be received if attendance or other participation in the course is not adequate to meet the educational objectives of the course as determined by the course sponsor. Credit may not be received if the EMS provider or EMSVO misses more than 15% of the time assigned for the course. Credit may not be received for other than 30- or 60-minute units of instruction. The course must be at least 30 minutes. For completing a continuing education course that is not presented in a classroom setting, or that is not presented by a continuing education sponsor, the EMS provider or EMSVO shall receive the number of credit hours assigned by the Department to the course.

 (b) Course completion. An EMS provider or EMSVO may not receive credit for a continuing education course not completed, as evidenced by satisfaction of the check-in/check-out process for a course presented in a classroom setting by a continuing education sponsor, which reflects that the EMS provider or EMSVO met the continuing education attendance requirement for receiving credit, and the continuing education sponsor's report to the Department verifying that the EMS provider or EMSVO has completed the course. The course will not be considered completed if the EMS provider or EMSVO does not satisfy other course completion requirements imposed by this chapter and the continuing education sponsor.

 (c) Continuing education credit for instruction. An EMS provider or EMSVO shall receive credit for serving as an instructor in a continuing education course offered by a continuing education sponsor, or in a course that satisfies requirements for EMS provider or EMSVO certification conducted by an EMS educational institute. An EMS provider or EMSVO shall receive credit for teaching a continuing education course equal to the amount of credit for which a continuing education course is approved by the Department, and shall receive credit for teaching a course that satisfies requirements for EMS provider or EMSVO certification equal to the number of hours served as an instructor in that course. An EMS provider or EMSVO shall receive credit for teaching the same course only once during a registration renewal cycle.

 (d) Continuing education credit through endorsement. An EMS provider or EMSVO who attends or teaches a course offered by an organization with National or State accreditation to provide education may apply to the Department to receive credit for the course. The EMS provider or EMSVO shall have the burden of demonstrating to the Department that the course meets standards substantially equivalent to the standards imposed in this chapter.

 (e) Continuing education credit assigned to courses not conducted by a continuing education sponsor. If a course is offered by an organization with National or State accreditation to provide education, which is not a continuing education sponsor, the Department will assign credit to the course, including the possibility of no credit or partial credit, based upon considerations of whether the course is based entirely upon appropriate subject matter and whether the method of presenting the course meets standards substantially equivalent to those prescribed in this chapter.

 (f) Continuing education credit assigned to self-study courses. Credit may be sought from the Department for a self-study continuing education course. The EMS provider or EMSVO shall submit an application to the Department to approve the self-study course for credit prior to beginning the course and supply the Department with the materials the Department requests to conduct the evaluation. The Department will assign credit to the course, including the possibility of no credit or partial credit, based upon considerations of whether the course addresses appropriate subject matter and whether the method of completing the course meets standards substantially equivalent to those prescribed in this chapter. The Department may require modifications to the proposed self-study as a precondition to approving it for credit.

 (g) Continuing education credit assigned to courses not presented in a classroom setting. An EMS provider or EMSVO shall be awarded credit for completing a course without the EMS provider or EMSVO physically attending the course in a classroom setting, provided the course has been approved by the Department for credit when presented in that manner.

 (h) Department record of continuing education credits. A record of the continuing education credits received by EMS providers and EMSVOs shall be maintained by the Department in a Statewide registry that may be accessed by an EMS provider or EMSVO through a secure access process provided by the Department.

 (i) Resolution of discrepancies. It is the responsibility of an EMS provider and an EMSVO to review the record of continuing education credits in the Statewide registry for that individual and to notify the appropriate regional EMS council of any discrepancy. The Department will resolve all discrepancies between the number of continuing education credits reported and the number of continuing education credits an EMS provider or EMSVO alleges to have earned, which are not resolved by the regional EMS council. An EMS provider and an EMSVO will not receive credit for completing the same continuing education course more than once during a registration renewal cycle.

§ 1023.33. Endorsement of course or examination.

 (a) When acting upon an application for EMS provider certification, the Department may endorse as satisfying the education or examination requirement for the certification a National course or examination taken by the applicant, or a course or examination taken by the applicant in another state to meet that state's course or examination requirement for the same or equivalent certification, if the Department determines that the course or examination meets or exceeds the standards for the course or examination requirement for the EMS provider certification issued by the Department.

 (b) When acting upon an application for registration of an EMS provider certification, the Department may endorse as satisfying the continuing education or examination requirement for registration of the certification a National course or examination taken by the applicant, or a course or examination taken by the applicant in another state to meet that state's course or examination requirement for renewal or registration of the same or equivalent certification, if the Department determines that the course or examination meets or exceeds the standards for the course or examination requirement for registration of the EMS provider certification issued by the Department.

§ 1023.34. Reciprocity.

 (a) If the Department, upon review of the criteria for certification or equivalent authorization of a type of EMS provider in another state determines that the criteria is substantially equivalent to the criteria for a type of EMS provider certification it issues, the Department may enter into a reciprocity agreement with its counterpart agency in the other state to certify the same type of provider in this Commonwealth based solely upon the other state's certification of the EMS provider, provided:

 (1) The agreement provides that the counterpart authority in the other state will accord the equivalent EMS provider certified by the Department the same treatment in the other state.

 (2) The agreement does not deprive the Department of its authority to deny a certification based upon disciplinary considerations.

 (b) The Department will publish in the Pennsylvania Bulletin, and update as appropriate, a notice listing the states with which it has entered into a reciprocity agreement and, for each state, the type of EMS provider covered by the reciprocity agreement.

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Subchapter C. OTHER PERSONS ASSOCIATED WITH THE STATEWIDE EMS SYSTEM

Sec.

1023.51.	Certified EMS instructors.
1023.52.	Rescue personnel.

§ 1023.51. Certified EMS instructors.

 (a) Certification. The Department will certify as an EMS instructor an individual who meets the following qualifications:

 (1) Has completed an application for EMS instructor certification on a form or through an electronic process, as prescribed by the Department.

 (2) Is 18 years of age or older.

 (3) Has successfully completed an EMS instructor course approved by the Department or possesses, at a minimum, a bachelor's degree in education or a teacher's certification in education.

 (4) Has provided at least 20 hours of instruction time in an EMS provider educational course monitored by a certified EMS instructor designated by the EMS educational institute's administrative director.

 (5) Possesses current certification as an EMT or higher level EMS provider.

 (6) Possesses current certification in CPR or current certification as a CPR instructor.

 (7) Possesses at least 1 year experience in providing EMS as an EMT or higher level EMS provider.

 (b) Triennial registration. An EMS instructor certification is deemed registered for 3 years. Thereafter, an EMS instructor shall triennially register the certification by completing a form or through an electronic process, as prescribed by the Department. An EMS instructor shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMS instructor certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the EMS instructor completes the form or the electronic process if the information provided establishes that the EMS instructor has met the following requirements:

 (1) Has provided documentation to the Department to establish that the individual conducted at least 60 hours of teaching EMS provider or rescue courses during the previous 3 years.

 (2) Possesses current registration of a certification as an EMT or higher level EMS provider.

 (3) Possesses current certification in CPR or a current certification as a CPR instructor.

 (c) Standards for providing instruction. An EMS instructor shall satisfy the following in providing instruction in an EMS educational institute:

 (1) Present EMS educational program course materials as required under § 1025.1(h)(6) (relating to accreditation and operational requirements of EMS educational institutes).

 (2) Utilize a variety of instructional strategies, adapting to students with diverse backgrounds and different learning styles.

 (3) Establish and clearly communicate to students the goals and objectives for the certification class being taught and administer periodic evaluations to assess whether those goals and objectives are being met.

 (4) Maintain class order and discipline, manage the classroom learning environment and monitor the effectiveness of instruction.

 (5) Ensure proper class time management with particular attention to completion of required class hours.

§ 1023.52. Rescue personnel.

 (a) Basic rescue practices technician.

 (1) Roles and responsibilities. A basic rescue practices technician is an individual certified by the Department as possessing the training and skills to perform rescue skills in accordance with the basic rescue practices course approved by the Department in consultation with the State Fire Commissioner. A basic rescue practices technician utilizes basic tools and equipment of the rescue service to perform a safe and efficient rescue operation.

 (2) Minimum qualifications. To secure certification as a basic rescue practices technician, an applicant shall make application for basic rescue practices technician certification on a form or through an electronic process, as prescribed by the Department, and shall have successfully completed a training program for basic rescue practices approved by the Department and a written basic rescue practices test developed by the Department.

 (b) Basic vehicle rescue technician.

 (1) Roles and responsibilities. A basic vehicle rescue technician is an individual certified by the Department as possessing the training and skills to perform rescue skills in accordance with the basic vehicle rescue course approved by the Department in consultation with the State Fire Commissioner. The program provides the student with the knowledge and skills necessary to achieve the rescue of persons involved in automobile accidents.

 (2) Minimum qualifications. To secure certification as a basic vehicle rescue technician, an applicant shall make application for basic vehicle rescue practices technician certification on a form or through an electronic process, as prescribed by the Department, and shall have successfully completed a training program for basic vehicle rescue approved by the Department and a written basic vehicle rescue practices test developed by the Department.

 (c) Special vehicle rescue technician.

 (1) Roles and responsibilities. A special vehicle rescue technician is an individual certified by the Department as possessing the training and skills to perform rescues in accordance with the specialized rescue training course approved by the Department in consultation with the State Fire Commissioner.

 (2) Minimum qualifications. To secure certification as a special vehicle rescue technician, an applicant shall make application for special vehicle rescue practices technician certification on a form or through an electronic process, as prescribed by the Department, and shall have successfully completed a training program for specialized vehicle rescue approved by the Department and a written special vehicle rescue technician test developed by the Department.

 (d) Rescue instructor. The Department will develop a program in consultation with the State Fire Commissioner providing for the certification of rescue instructors. Courses that seek Department approval as a rescue training course for a basic rescue practices technician, basic vehicle rescue technician or special vehicle rescue technician shall be taught by certified rescue instructors.

 (e) Certificates. The rescue technician certifications issued by the Department under this section do not constitute a legal prerequisite for the performance of rescues. The rescue instructor certifications issued by the Department under this section do not constitute a legal prerequisite for serving as a rescue instructor in programs other than rescue training courses approved by the Department. The Department approves the rescue programs and issues the certifications referenced within this section to promote the Statewide EMS system having personnel with sufficient education and skills to perform rescues.

CHAPTER 1025. EDUCATION

Subchap.

A.	EMS EDUCATIONAL INSTITUTES
B.	EMS CONTINUING EDUCATION COURSES

Subchapter A. EMS EDUCATIONAL INSTITUTES

Sec.

1025.1.	Accreditation and operational requirements of EMS educational institutes.
1025.2.	Accreditation process.
1025.3.	Advertising.

§ 1025.1. Accreditation and operational requirements of EMS educational institutes.

 (a) Eligible entity. An EMS educational institute shall be a secondary or postsecondary institution, hospital, regional EMS council, an educational institute in a branch of the armed forces or another entity which meets the criteria in this chapter.

 (b) Educational programs.

 (1) An EMS educational institute that is accredited by the Department to offer BLS educational courses (BLS educational institute) shall evidence the ability to conduct one or more of the following EMS provider educational courses:

 (i) Emergency medical responder course.

 (ii) Emergency medical technician course.

 (2) An EMS educational institute that is accredited by the Department to offer ALS educational courses (ALS educational institute) shall evidence the ability to conduct one or more of the following EMS provider educational courses:

 (i) Advanced emergency medical technician course.

 (ii) Paramedic course.

 (3) An EMS educational institute shall register with the Department the location and staffing plan of a course it offers towards satisfying an EMS provider certification educational requirement at least 30 business days before the first class is held.

 (c) Advisory committee.

 (1) An EMS educational institute shall have an advisory committee that is comprised of representatives of the EMS communities that have an interest in the EMS provider educational courses the institute offers, and which also includes a representative of an appropriate regional EMS council and the institute's medical director.

 (2) The advisory committee shall meet at least annually and assist program personnel in formulating and periodically revising appropriate goals and objectives and in monitoring the EMS educational institute's performance.

 (d) Disclosure to students and prospective students. An EMS educational institute shall disclose the following to students and prospective students:

 (1) The institute's accreditation status.

 (2) The Department is the accrediting body, the contact information for the Department and the regional EMS councils where its courses are offered, as provided to the institute by the Department and those regional EMS councils.

 (3) The institute's admissions, discipline and discharge policies and practices.

 (4) The functional job analysis of each EMS provider classification for which it is offering an EMS provider educational course.

 (5) The requirements for completing each EMS provider educational course it offers, including, to the extent known, advance notice of the books and materials required for each course.

 (6) The tuition fees and other costs involved in completing each EMS provider educational course.

 (7) The policy and process for withdrawal from a course and the refund of tuition and other fees.

 (8) Information as to how students may perform clinical work while enrolled in an EMS provider educational course.

 (9) The percentage of students for the previous 3 years who enrolled in and completed each EMS provider educational course offered by the institute.

 (10) The percentage of students for the previous 3 years, for each EMS provider educational course, who obtained EMS provider certification, and a percentage of the students who obtained certification after a first examination.

 (11) The regulatory requirements for testing leading to EMS provider certification.

 (12) The EMS educational institute's policies for the prevention of sexual harassment.

 (e) Medical director.

 (1) An EMS educational institute shall have a medical director who is a physician. The medical director shall be experienced in emergency medical care and have demonstrated ability in education and administration.

 (2) The responsibilities of the medical director shall include:

 (i) Reviewing course content to ensure compliance with this chapter.

 (ii) Reviewing and approving the EMS educational institute's criteria for the recruitment, selection and orientation of educational institute faculty.

 (iii) Providing technical advice and assistance to the EMS educational institute faculty and students.

 (iv) Reviewing the quality and medical content of the education and compliance with protocols.

 (v) Participating in the review of new technology for training and education.

 (3) Additional responsibilities for a medical director of an ALS educational institute include:

 (i) Approving the content of course written and practical skills examinations.

 (ii) Identifying and approving facilities where students are to fulfill clinical and field internship requirements.

 (iii) Identifying and approving individuals to serve as field and clinical preceptors to supervise and evaluate student performance when fulfilling clinical and field internship requirements.

 (iv) Signing skill verification forms for students who demonstrate the knowledge and skills required for successful completion of the EMS provider educational course and entry level competency for the EMS provider for which the EMS provider educational course is offered.

 (f) Administrative director.

 (1) A BLS educational institute shall have an administrative director who has at least 2 years of experience in administration and 3 years of experience in prehospital care.

 (2) An ALS educational institute shall have an administrative director who has at least 2 years of experience in administration and 3 years of experience in ALS prehospital care, and who has a Bachelor's degree from an accredited school of higher education and an EMS provider certification above the AEMT level.

 (3) Responsibilities of the administrative director include ensuring:

 (i) The adequacy of the system for processing student applications and the adequacy of the student selection process.

 (ii) The adequacy of the process for the screening and selection of instructors for the EMS educational institute.

 (iii) The EMS educational institute maintains an adequate inventory of necessary educational equipment and that the training equipment is properly prepared and maintained.

 (iv) The adequate administration of the course and written and practical skills examinations involved in the course.

 (v) There is an adequate system for the maintenance of student records and files.

 (vi) There is an appropriate mechanism to resolve disputes between students and faculty.

 (4) The administrative director shall serve as the contact person and liaison between the EMS educational institute and the Department and regional EMS councils. The administrative director may designate another person to perform those functions and monitor that person's performance to ensure that the contact and liaison responsibilities are being satisfied.

 (g) Course coordinator.

 (1) The EMS educational institute shall designate a course coordinator for each EMS provider educational course conducted by the educational institute.

 (2) A course coordinator shall satisfy the following requirements:

 (i) Reading and language skills commensurate with the resource materials to be utilized in the course.

 (ii) Knowledge of the Statewide EMS protocols and of the regional EMS protocols for each EMS region where the course is offered.

 (iii) Three years of clinical experience providing prehospital care as an EMS provider at or above the EMT level.

 (iv) Certification as an EMS instructor.

 (3) The 3 years of clinical experience providing prehospital care of a course coordinator for an ALS educational course shall be as an EMS provider above the AEMT level.

 (4) A course coordinator is responsible for the management and supervision of each EMS provider educational course offered by the educational institute for which that individual serves as a course coordinator.

 (5) Specific duties of a course coordinator shall be assigned by the EMS educational institute.

 (6) One person may serve both as the administrative director and a course coordinator.

 (h) Instructors.

 (1) An EMS educational institute shall ensure the availability of qualified and responsible instructors for each EMS provider educational course.

 (2) The EMS educational institute shall make available faculty development for EMS instructors in the concepts of utilizing a variety of instructional strategies, adapting to students with diverse backgrounds and different learning styles and be responsible for ensuring that its instructors are competent in providing education employing those instructional strategies.

 (3) An instructor shall be 18 years of age or older and possess a high school diploma or GED equivalent.

 (4) At least 75% of the instruction provided in EMS provider educational courses shall be provided by instructors who are either of the following:

 (i) EMS instructors certified by the Department who have at least 3 years of experience as an EMS provider at or above the level they are teaching and at least 2 years of experience in teaching an EMS provider educational course at or above the level they are teaching.

 (ii) Determined by the course coordinator and the medical director of the EMS educational institute to meet or exceed these standards.

 (5) The EMS educational institute's medical director, in consultation with appropriate course coordinators, is responsible for verifying the special expertise of an instructor who does not satisfy the requirements in paragraph (4) and for specifying the portions of the curriculum that are appropriate for the instructor to teach.

 (6) Instructors are responsible for presenting course materials in accordance with the curriculum established or approved for the course by the Department for the EMS provider level of the course and the Statewide EMS protocols applicable to that EMS provider level.

 (i) Clinical preceptors.

 (1) An EMS educational institute shall ensure the availability of clinical preceptors for each EMS provider educational course.

 (2) A clinical preceptor is responsible for the supervision and evaluation of students while fulfilling clinical requirements for an EMS provider educational course.

 (j) Field preceptors.

 (1) An EMS educational institute shall ensure the availability of qualified field preceptors for each student enrolled in an EMS provider educational course at or above the AEMT level.

 (2) An EMS educational institute shall ensure the availability of a qualified field preceptor for each student enrolled in an EMS provider educational course below the AEMT level for whom it provides a field internship.

 (3) An EMS educational institute shall use as a field preceptor for an EMS provider educational course an EMS provider who is certified and practicing at or above the level of the EMS provider certification for which the course is being taught.

 (4) A field preceptor is responsible for the supervision and evaluation of students while fulfilling a field internship for an EMS provider educational course. A field preceptor shall directly supervise a student's performance of any EMS skill for which the student does not have an EMS provider certification under which the student is authorized to perform the skill.

 (k) Facilities and equipment. An EMS educational institute shall:

 (1) Maintain educational facilities necessary for the provision of EMS provider educational courses, including satisfying applicable State and Federal standards to address the needs of persons with disabilities. The facilities shall include classrooms and space for equipment storage and be of sufficient size and quality to conduct didactic and practical skill performance sessions.

 (2) Provide, properly prepare and maintain the essential equipment, including simulators and task trainers, and the supplies to administer the course.

 (l) Operating procedures. An EMS educational institute shall:

 (1) Adopt and implement a nondiscrimination policy with respect to student selection and faculty recruitment.

 (2) Maintain a file on each enrolled student which includes class performance, practical and written examination results, and reports made concerning the progress of the student during the EMS provider educational course.

 (3) Provide a mechanism by which students may grieve decisions made by the institute regarding dismissal from an EMS provider educational course or other disciplinary action.

 (4) Provide students with preparation for testing leading to EMS provider certification.

 (5) Have a policy regarding the transfer of a student into or out of an EMS provider educational course from one EMS educational institute to another.

 (6) Have a continuing quality improvement process in place for students, instructors and clinical evaluation.

 (7) Require each student applicant to complete an application for enrollment provided by the Department.

 (8) Prepare a course completion form for each student who successfully completes the EMS provider educational course and, no later than 14 days after the educational course has concluded, forward that form to the regional EMS council having responsibility in the EMS region where the EMS educational institute operates.

 (9) Participate in EMS educational institute system evaluation activities as requested by the Department.

 (10) Require each student to complete and submit the form or complete the electronic process, as prescribed by the Department, under § 1023.21(b) (relating to general rights and responsibilities) for reporting criminal convictions, discipline and exclusion from a State or Federal health care program. The EMS educational institute shall inform each student of the duty to update the report if there is a change in this information before the Department acts upon the student's application for EMS provider certification.

 (11) Forward a copy of the form completed under paragraph (10) to the regional EMS council having responsibility in the EMS region where the EMS educational institute operates, no later than 14 days after the first class session.

 (m) Providing access to facility and records. An EMS educational institute and an applicant for EMS educational institute accreditation shall promptly make available to the Department or a regional EMS council, upon request, its educational facility for inspection and provide them with complete and accurate records relating to the institute's compliance with the requirements in this subchapter.

 (n) Transitional requirements. This section applies to an EMS educational institute that is accredited on ______ (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) beginning with its initial application for reaccreditation as an EMS educational institute on or after ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) and to its operations as an EMS educational institute beginning with its accreditation under that application.

§ 1025.2. Accreditation process.

 An EMS educational institute shall meet the following requirements to be accredited by the Department:

 (1) The applicant shall submit an application for accreditation on forms or through an electronic process, as prescribed by the Department, to the regional EMS council having responsibility in the EMS region where the EMS educational institute intends to conduct its primary operations. An applicant for reaccreditation shall submit the application at least 180 days, but not more than 1 year, prior to expiration of the current accreditation.

 (2) The regional EMS council shall review the application for completeness and accuracy.

 (3) The regional EMS council shall have 30 days in which to review the application, conduct an onsite assessment of the institute and determine whether the applicant has satisfied the requirements in § 1025.1 (relating to accreditation and operational requirements of EMS educational institutes).

 (4) The regional EMS council shall forward to the Department the application for accreditation either with an endorsement or an explanation as to why the application has not been endorsed, citing regulatory standards it believes have not been satisfied.

 (5) Within 150 days of receipt, the Department will review the application and make one of the following determinations:

 (i) Full accreditation. The EMS educational institute meets the criteria in § 1025.1, as applicable, and will be accredited to operate for 3 years.

 (ii) Conditional accreditation. The EMS educational institute does not meet criteria in § 1025.1, as applicable, but the deficiencies identified are deemed correctable by the Department. The EMS educational institute will be allowed to proceed or continue to provide accredited EMS education with close observation by the Department. Deficiencies which prevent full accreditation shall be enumerated and corrected within a time period specified by the Department. Conditional accreditation may not exceed 1 year and may not be renewed.

 (iii) Nonaccreditation. The institute does not meet criteria in § 1025.1 and the deficiencies identified are deemed to be serious enough to preclude any type of accreditation.

 (6) An EMS educational institute that has received full or conditional accreditation shall submit status reports to the Department as requested.

 (7) Prior to and during accreditation, an EMS educational institute is subject to review, including inspection of records, facilities and equipment by the Department. An authorized representative of the Department may enter, visit and inspect an accredited EMS educational institute or a facility operated by or in connection with the EMS educational institute with or without prior notification. The Department may accept the survey results of another accrediting body if the Department determines that the accreditation standards of the other accrediting body are equal to or exceed the standards in this chapter, and that the survey process employed by the other accrediting body is adequate to gather the information necessary for the Department to make an accreditation decision.

 (8) An EMS educational institute shall advise the Department at least 90 days prior to an intended change of ownership or control of the institute. Accreditation is not transferable to new owners or controlling parties.

 (9) An EMS educational institute that intends to conduct an EMS educational course in an EMS region under the jurisdiction of a regional EMS council other than that through which it submitted its application for accreditation shall file a written application to amend its accreditation with the regional EMS council having responsibility for the region in which it intends to conduct these courses. That application shall be processed by that regional EMS council and acted upon by the Department within 90 days.

§ 1025.3. Advertising.

 (a) An entity may advertise an educational course in a manner that states or suggests that the successful completion of the course satisfies the EMS provider educational course requirement for an EMS provider certification issued by the Department only after the entity has been accredited by the Department as an EMS educational institute and the course has been approved by the Department for that purpose under § 1025.2 (relating to accreditation process).

 (b) When an EMS provider educational course has been approved under § 1025.2, the EMS education institute shall announce the following in its brochures or registration materials: This course has been approved by the Pennsylvania Department of Health as meeting the educational course requirement that an applicant for certification as a/an (the type of EMS provider or EMS vehicle operator to which the course applies) needs to satisfy to be certified by the Pennsylvania Department of Health as a/an (the type of EMS provider or EMS vehicle operator to which the course applies).

Subchapter B. EMS CONTINUING
EDUCATION COURSES

Sec.

1025.21.	Accreditation of sponsors of continuing education.
1025.22.	Responsibilities of continuing education sponsors.
1025.23.	Advertising.

§ 1025.21. Accreditation of sponsors of continuing education.

 (a) Entities and institutions may apply for accreditation as a continuing education sponsor by submitting to the Department an application on a form or through an electronic process, as prescribed by the Department. The applicant shall supply the information requested in the application. The Department will grant accreditation to an applicant for accreditation as a continuing education sponsor if the applicant satisfies the Department that the courses the applicant offers meet the following minimum standards:

 (1) The courses shall be of intellectual and practical content.

 (2) The courses shall contribute directly to the professional competence, skills and education of EMS providers or EMSVOs.

 (3) The course instructors shall possess the necessary practical and academic skills to conduct the course effectively.

 (4) Course materials shall be well written, carefully prepared, readable and distributed to attendees at or before the time the course is offered whenever practical.

 (5) The courses shall be presented by a qualified responsible instructor in a suitable setting devoted to the educational purpose of the course.

 (b) Accreditation of the continuing education sponsor will be effective for 3 calendar years.

 (c) At least 90 days prior to expiration of the 3-year accreditation period, a continuing education sponsor shall apply to the Department for renewal of the sponsor's accreditation on a form or through an electronic process, as prescribed by the Department. The Department will renew the sponsor's accreditation if the sponsor meets the following requirements:

 (1) The sponsor has presented, within the preceding 3 years, a continuing education course or courses on at least five occasions which met the minimum standards in subsection (a).

 (2) The sponsor establishes to the Department's satisfaction that future courses to be offered by the sponsor will meet the minimum standards in subsection (a).

 (3) The sponsor has satisfied its responsibilities under § 1025.22 (relating to responsibilities of continuing education sponsors).

§ 1025.22. Responsibilities of continuing education sponsors.

 (a) Course approval. A continuing education sponsor shall submit, to the regional EMS council that exercises responsibility for the EMS region in which the continuing education sponsor intends to conduct a new continuing education course, an application for approval of that continuing education course. The continuing education sponsor shall submit that application at least 30 days prior to the date the continuing education sponsor expects to conduct the course.

 (b) Registration of course. A continuing education sponsor may not offer, for continuing education credit, a course for which it or another continuing education sponsor has received approval to offer as a continuing education course without registering with the Department the location of the class through which it intends to offer that course for continuing education credit at least 30 days before the class is held.

 (c) Record of attendance. A continuing education sponsor shall maintain a record of attendance for a course presented in a classroom setting by maintaining a check-in/check-out process approved by the Department and assign at least one person to ensure that the individuals attending the course check in when entering and check out when leaving. If an individual enters a course after the starting time, or leaves a course before the finishing time, the assigned person shall ensure that the time of arrival or departure is recorded for the individual.

 (d) Reporting attendance. A continuing education sponsor shall report to the Department, in the manner and format prescribed by the Department, attendance at each continuing education course presented in a classroom setting within 10 days after the course has been presented.

 (e) Course evaluation. A continuing education sponsor shall develop and implement methods to evaluate its course offerings to determine their effectiveness. The methods of evaluation shall include providing a course evaluation form to each person who attends a course. The continuing education sponsor shall provide a copy of the completed course evaluation forms to the regional EMS council within 10 days after the course has been presented.

 (f) Record retention. The continuing education sponsor shall retain the completed course evaluation forms for each course it presents and the check-in/check-out record for each course it presents in a classroom setting. These records shall be retained for at least 4 years from the presentation of the course.

 (g) Providing access to records. A continuing education sponsor and an applicant for accreditation as a continuing education sponsor shall promptly make available for inspection and provide the Department or a regional EMS council with complete and accurate records relating to its compliance with the requirements in this subchapter as requested by the Department or a regional EMS council.

 (h) Course not presented in a classroom setting. A continuing education sponsor shall be exempt from the requirements in subsections (a) and (b) for a course which is not presented in a classroom setting, if the course is approved by the Department for credit when presented in that manner. When presenting the course to the Department for approval for credit, the continuing education sponsor shall present a procedure for monitoring, confirming and reporting EMS provider or EMSVO participation in a manner that achieves the purposes of subsections (a) and (b).

 (i) Monitoring responsibilities. A continuing education sponsor shall ensure that a course was presented in a manner that met all of the educational objectives for the course and determine whether each EMS provider or EMSVO who enrolled in the course met the requirements in this chapter and the continuing education sponsor to receive credit for completing the course.

 (j) Course completion. A continuing education sponsor shall report to the Department, in a manner and format prescribed by the Department, completion of a course by an EMS provider or EMSVO and identify to the Department an EMS provider or EMSVO who seeks credit for a course but who did not meet the requirements of the continuing education sponsor or this chapter to receive continuing education credit. The continuing education sponsor shall also provide an EMS provider or EMSVO who completes a course with a document certifying completion of the course.

§ 1025.23. Advertising.

 (a) A continuing education sponsor may advertise a course as a continuing education course in a manner that states or suggests that the course meets the requirements in this chapter only if the course has been approved by the Department to be offered by that continuing education sponsor.

 (b) When a course has been approved for continuing education credit, the continuing education sponsor shall announce in the following its brochures or registration materials: This course has been approved by the Pennsylvania Department of Health for (the approved number of hours) of continuing education credit for (the type of EMS provider(s) or EMS vehicle operator to which the course applies).

 (c) If a continuing education sponsor advertises that it has applied to the Department to secure continuing education credit for a course, prior to presenting the course it shall disclose to all enrollees whether the course has been approved or disapproved for credit.

CHAPTER 1027. EMS AGENCIES

Subchap.

A.	GENERAL REQUIREMENTS
B.	EMS AGENCY SERVICES
C.	MISCELLANEOUS

Subchapter A. GENERAL REQUIREMENTS

Sec.

1027.1.	General provisions.
1027.2.	License and registration applications.
1027.3.	Licensure and general operating standards.
1027.4.	Medication use, control and security.
1027.5.	Statewide EMS response plan.
1027.6.	EMS vehicle fleet.
1027.7.	Removal of EMS vehicles from operation.
1027.8.	Right to enter, inspect and obtain records.
1027.9.	Notification of deficiencies to applicants.
1027.10.	Plan of correction.
1027.11.	Conditional temporary license.
1027.12.	Discontinuation or movement of operations or reduction of service.
1027.13.	Management companies.

§ 1027.1. General provisions.

 (a) License required. A person, or other entity, as an owner, agent or otherwise, may not operate, conduct, maintain, advertise or otherwise engage in or profess to be engaged in operating an EMS agency in this Commonwealth unless that person holds a license as an EMS agency and a current registration of that license issued by the Department or is exempt from these requirements. By way of example, an entity is operating an EMS agency if it operates any of the following:

 (1) An ambulance service.

 (i) BLS ambulance service.

 (ii) Intermediate ALS ambulance service.

 (iii) ALS ambulance service, including a critical care transport ambulance service.

 (iv) Air ambulance service.

 (2) A squad service.

 (i) BLS squad service.

 (ii) Intermediate squad service.

 (iii) ALS squad service.

 (3) A QRS.

 (4) A special operations EMS service.

 (i) Tactical EMS service.

 (ii) Wilderness EMS service.

 (iii) Mass-gathering EMS service.

 (iv) Urban search and rescue service.

 (b) License requirements. The Department will license an applicant as an EMS agency if the Department is satisfied that the applicant has met the following requirements:

 (1) The applicant and persons having a substantial ownership interest in the applicant are responsible persons and the EMS agency shall be staffed by and conduct its activities through responsible persons. For purposes of this paragraph:

 (i) A responsible person is a person who has not engaged in an act contrary to justice, honesty or good morals which indicates that the person is likely to betray the public trust in carrying out the activities of the EMS agency, or is a person who has engaged in this type of conduct but has been rehabilitated and is not likely to again betray the public trust.

 (ii) A person has a substantial ownership in the applicant if the person has equity in the capital, stock or the profits of the applicant equal to 5% or more of the property or assets of the applicant.

 (iii) A person staffs an EMS agency if the person engages in activity integral to the operation of the EMS agency, including participating in the making or execution of management decisions, providing EMS, billing, calltaking and dispatching.

 (2) The applicant meets the supply and equipment requirements for each EMS vehicle and type of EMS service it makes application to offer, and demonstrates that it shall be maintained and operated to safely and efficiently operate those vehicles and render those services.

 (3) The applicant shall meet staffing standards for the vehicles it seeks to operate and the services it seeks to provide. Subject to the exceptions in § 1027.5 (relating to Statewide EMS response plan), this includes providing EMS services 24 hours-a-day, 7 days-a-week or participating in a county-level or broader-level EMS response plan approved by the Department.

 (4) The applicant shall provide safe services that are adequate for the emergency medical care, treatment and comfort and, when applicable, the transportation of patients.

 (5) The applicant has an EMS agency medical director who satisfies requirements established by the Department based upon the types of services it seeks to provide and the EMS vehicles it seeks to operate.

 (6) The applicant satisfies the regulatory requirements relating to making its application for a license and has adopted policies and procedures adequate to ensure compliance with the requirements in the act, this part and notices the Department publishes in the Pennsylvania Bulletin that are applicable to its operations.

 (c) License certificate. The Department will issue a license certificate to an applicant that it licenses as an EMS agency. The license certificate will specify the name of the EMS agency, its license number, the address of its primary operational headquarters and the date the license was issued. The Department will also issue with the license certificate a document that specifies the type or types of EMS agency services the EMS agency is licensed to provide, the types of EMS vehicles the agency will operate, the locations out of which it is authorized to provide that service or services if more than one location is involved, the fictitious name, if any, under which it conducts its operations at each location involved, and the name of the regional EMS council through which the license application was processed. The Department will replace that document if there is a need to change the information on it due to a license amendment.

 (d) License registration. An EMS agency requires both an EMS agency license and current registration of that license to conduct its operations. When the Department registers an EMS agency's license it will issue a registration certificate to the EMS agency that specifies the name of the EMS agency, its license number, the address of its primary operational headquarters and the dates the registration is effective and will expire.

 (e) Transition for ambulance services and QRSs.

 (1) An entity that is licensed as an ambulance service or recognized as a QRS by the Department, or a hospital that operates an ambulance service or QRS under its hospital license, immediately prior to ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) will be licensed by the Department as an EMS agency, with a current registration of that license on ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) if the records of the Department reflect that the ambulance service, QRS or hospital has an EMS agency medical director. The license and registration will authorize the EMS agency to operate the EMS vehicles and provide the services it was authorized to operate and provide when licensed as an ambulance service, recognized as a QRS, or operated under a hospital license.

 (2) An entity that is licensed as an ambulance service or recognized as a QRS by the Department, or operates an ambulance service under a hospital license, immediately prior to ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) that does not have an EMS agency medical director may continue to operate as an ambulance service or QRS under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)) until ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) without securing an EMS agency license.

§ 1027.2. License and registration applications.

 (a) License application. An application for an EMS agency license shall be submitted on a form or through an electronic process, as prescribed by the Department. The application must contain the following information as well as an additional information and documents that may be solicited by the application form:

 (1) The name and mailing address of the applicant and a primary contact person and telephone number at which that person can be reached.

 (2) The name under which the applicant will be holding itself out to the public in conducting its EMS agency operations and the address of its primary location in this Commonwealth out of which it will be conducting its EMS agency operations. If the applicant seeks to conduct EMS agency operations out of more than one location, the address of its primary operational headquarters and each other location out of which it intends to operate. If the applicant will be holding itself out to the public under different fictitious names for the EMS agency operations it will conduct at different locations, the fictitious name under which it intends to operate at each location.

 (3) The manner in which the applicant is organized—corporation, partnership, limited liability company, sole proprietorship, and the like.

 (4) The tax status of the applicant—profit or nonprofit.

 (5) The type of EMS service or services the applicant intends to provide.

 (6) The geographic area for which the applicant intends to provide the service for each type of service it intends to operate. If the service is a type of service that is dispatched by a PSAP, the geographic area, if any, in which it plans to routinely respond to emergency dispatches.

 (7) A personnel roster and staffing plan or personnel rosters and staffing plans, if applicable.

 (8) The number and types of EMS vehicles to be operated by the applicant and identifying information for each EMS vehicle.

 (9) The communication access and capabilities of the applicant.

 (10) A full description of the EMS agency services that it intends to provide out of each location and how it intends to respond to emergency calls if it will not conduct operations out of a fixed location or locations.

 (11) The names, titles and summary of responsibilities of persons who will be staffing the EMS agency as officers, directors or other EMS agency officials, and the same information pertaining to them that an EMS provider is required to report under § 1023.21(b)(1) and (2) (relating to general rights and responsibilities).

 (12) Information concerning any arrangement in which it has entered to manage an EMS agency or any contract with an entity for that entity to exercise operational or managerial control over the EMS agency, or to conduct the day-to-day operations of the EMS agency.

 (13) A statement attesting to the veracity of the application, which shall be signed by the principal official of the applicant.

 (b) Submission of license application. The applicant shall submit the application to the regional EMS council exercising responsibility for the EMS region in which the applicant will conduct its operations if licensed. If the applicant seeks a license to conduct EMS agency operations in more than one region, it shall choose a primary operational headquarters and submit its license application to the regional EMS council that exercises responsibility for the region in which that primary operational headquarters is located. If the applicant's primary operational headquarters is located outside this Commonwealth, the applicant shall contact the Department for direction as to the regional EMS council to which it is to submit its application.

 (c) Processing the license application.

 (1) The regional EMS council that receives a license application shall review the application for completeness and accuracy. It shall also provide a copy of the application to each regional EMS council that exercises responsibility for an EMS region in which the applicant intends to conduct EMS agency operations. If more than one regional EMS council is involved in the review, they shall coordinate their review with the regional EMS council that exercises responsibility for the EMS region in which the applicant's primary operational headquarters is located, and that regional EMS council shall communicate with the applicant regarding any issues presented by the application.

 (2) The regional EMS council that has responsibility for communicating with the applicant under paragraph (1) shall return an incomplete application to the applicant within 14 days of receipt.

 (3) If the regional EMS council that has responsibility for communicating with the applicant under paragraph (1) determines that the application contains inaccurate information, and that the nature of the inaccurate information does not suggest fraud or deceit in attempting to obtain a license, the regional EMS council shall return the application to the applicant for correction.

 (4) Upon receipt of a complete application, and its verification of the accuracy of the information provided in the application which is verifiable without an onsite inspection, the regional EMS council shall schedule and conduct an onsite inspection of the applicant's vehicles, equipment and personnel qualifications, as well as other matters that bear upon whether the applicant satisfies the statutory and regulatory criteria for licensure. The inspection shall be performed within 45 days after receipt by the regional EMS council of an application that is complete and, if requested by the regional EMS council, that has been corrected. If the applicant seeks to conduct EMS agency operations in more than one EMS region, the regional EMS council that has responsibility for communicating with the applicant under paragraph (1) may seek the assistance of other relevant regional EMS councils in conducting onsite surveys.

 (5) Upon completion of its review, the regional EMS council that has responsibility for communicating with the applicant under paragraph (1) shall forward the application to the Department, with the regional EMS council's assessment as to whether applicable statutory and regulatory requirements are satisfied. If the regional EMS council determines that the application contains inaccurate information that suggests fraud or deceit by the applicant in attempting to obtain a license, the regional EMS council may forward the application to the Department without having conducted an onsite inspection and await instructions from the Department as to whether an onsite inspection should be conducted.

 (d) Amendment of license.

 (1) An EMS agency shall apply for and secure an amendment of its license prior to changing the location of any of its operations, the days or hours of the services it provides or the types of services it provides, or prior to arranging for an entity to exercise operational or managerial control over the EMS agency or to conduct the day-to-day operations of the EMS agency.

 (2) An EMS agency shall submit its application for amendment of its license on a form or through an electronic process, as prescribed by the Department, to the regional EMS council responsible for the EMS region in which the EMS agency maintains its primary operational headquarters. That regional EMS council shall process the application for amendment as set forth in subsections (b) and (c).

 (e) Triennial registration. An EMS agency's license is deemed registered for 3 years after issuance, except for an EMS agency that transitions from an ambulance service, a QRS, an ambulance service that operated under a hospital license on ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) under § 1027.1(e) (relating to general provisions), in which case the initial registration shall expire when its license or recognition would have expired under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)) or, in the case of a hospital, under the Health Care Facilities Act (35 P. S. §§ 448.101—448.904b). Thereafter, an EMS agency shall triennially register the license by completing a form or through an electronic process, as prescribed by the Department, and filing it with the regional EMS council responsible for the EMS region in which the EMS agency maintains its primary operational headquarters. An EMS agency shall submit the form or complete the electronic process at least 120 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMS agency license not being registered again before the prior registration expires. The Department will act on an application for registration within 90 days after a regional EMS council receives a complete and accurate application. The Department may also deny an application after it is received by a regional EMS council if it contains false information, subject to notice and an opportunity for a hearing before the denial would become effective, or it may grant the application and then pursue disciplinary action against the EMS agency based upon the false information provided.

§ 1027.3. Licensure and general operating standards.

 (a) Documentation requirements for licensure. An applicant for an EMS agency license shall have the following documents available for inspection by the Department or a regional EMS council:

 (1) A roster of active personnel, including the EMS agency medical director, with certification and registration documentation including certification numbers and dates of registration expiration for each EMS provider and EMSVO.

 (2) A record of the age of each EMS provider and EMSVO and a copy of the driver's license for each EMSVO.

 (3) Documentation, if applicable, of the initial and most recent review of each EMS provider's competence by the EMS agency medical director and the EMS provider certification level at which each EMS provider is permitted to practice.

 (4) Its process for scheduling staff to ensure that the minimum staffing requirements as required by this chapter are met.

 (5) Identification of persons who are responsible for making operating and policy decisions for the EMS agency, such as officers, directors and other EMS agency officials.

 (6) Criminal, disciplinary and exclusion information for all persons who staff the EMS agency as required under subsection (f).

 (7) Copies of the Statewide and applicable regional EMS protocols.

 (8) Copies of the written policies required under this section.

 (9) Copies of documents by which it agrees to manage another EMS agency or to be managed by another entity.

 (b) Documentation requirements after licensure. An EMS agency shall have the following documents available for inspection by the Department or a regional EMS council when it applies for registration of its license and at all other times:

 (1) The documents that are required to be available for inspection under subsection (a).

 (2) EMS PCRs.

 (3) Call volume records from the previous year's operations. These records must include a record of each call received requesting the EMS agency to respond to an emergency, as well as a notation of whether it responded to the call and the reason if it did not respond.

 (4) A record of the time periods for which the EMS agency notified the PSAP, under subsection (g)(1), that it would not be available to respond to a call.

 (c) EMS vehicles, equipment and supplies. The Department will publish in the Pennsylvania Bulletin, and update as necessary, vehicle construction, and equipment and supply requirements for EMS agencies based upon the types of services they provide and the EMS vehicles they operate. Required equipment and supplies shall be carried and readily available in working order.

 (d) Use of persons under 18 years of age. The EMS agency shall comply with the Child Labor Law (43 P. S. §§ 41—66.1) and regulations adopted under the Child Labor Law when it is using persons under 18 years of age to staff its operations. The EMS agency shall also ensure that an EMS provider under 18 years of age, when providing EMS on behalf of the EMS agency, is directly supervised by an EMS provider who is at least 21 years of age who has the same or higher level of EMS provider certification and at least 1 year of active practice as an EMS provider.

 (e) EMS agency medical director. An EMS agency shall have an EMS agency medical director.

 (f) Responsible staff. An EMS agency shall ensure that persons who staff the EMS agency, including its officers, directors and other members of its management team, EMS providers and EMSVOs, are responsible persons. In making that determination, it shall require each person who staffs the EMS agency to provide it with the information and documentation an EMS provider is required to provide to the Department under § 1023.21(b) (relating to general rights and responsibilities) and require each EMSVO to provide it with the information and documentation an EMSVO is required to provide to the Department under § 1023.21(b), and to update that information if and when additional convictions, disciplinary sanctions and exclusions occur. The EMS agency shall consider this information in determining whether the person is a responsible person. An EMS agency shall also provide the Department with advance notice, 30 days if possible, of any change in its management personnel to include as a new member of its management team a person who has reported to it information required under this subsection.

 (g) Communicating with PSAPs.

 (1) Responsibility to communicate unavailability. An EMS agency shall apprise the PSAP in its area, in advance, as to when it will not be in operation due to inadequate staffing or for another reason and when its resources are committed in a manner that it will not be able to respond with an EMS vehicle, if applicable and required staff, to a request to provide EMS.

 (2) Responsibility to communicate delayed response. An EMS agency shall apprise the PSAP, as soon as practical after receiving a dispatch call from the PSAP, if it is not able to have an appropriate EMS vehicle, if applicable, or otherwise provide the requested level of service, including having the required staff en route to an emergency within the time as may be prescribed by a PSAP for that type of dispatch.

 (3) Responsibility to communicate with PSAP generally. An EMS agency shall provide a PSAP with information, and otherwise communicate with a PSAP, as the PSAP requests to enhance the ability of the PSAP to make dispatch decisions.

 (4) Response to dispatch by PSAP. An EMS agency shall respond to a call for emergency assistance as communicated by the PSAP, provided it is able to respond as requested. An EMS agency is able to respond as requested if it has the staff and an operational EMS vehicle, if needed, capable of responding to the dispatch. An EMS agency may not refuse to respond to a dispatch based upon a desire to keep staff or an EMS vehicle in reserve to respond to other calls to which it has not already committed.

 (h) Dispatching.

 (1) An EMS agency dispatch center shall use calltakers and dispatchers who are certified and maintain certification as calltakers and dispatchers by the Pennsylvania Emergency Management Agency under 35 Pa.C.S. § 5303(a)(6) (relating to telecommunications management).

 (i) A calltaker is responsible for taking calls seeking EMS and for gathering the essential information from the caller to determine whether EMS is needed and, if required, the location to which EMS resources need to be sent.

 (ii) A dispatcher is responsible for taking the information gathered by the calltaker, determining the appropriate EMS response to the situation and dispatching the EMS resources needed to respond to the EMS needs of the patient or patients.

 (2) With the exception of the responsibilities calltakers and dispatchers have under paragraph (1), paragraph (1) shall be effective ______  (Editor's Note: The blank refers to 2 years after the effective date of adoption of this proposed rulemaking.).

 (3) The costs of the Pennsylvania Emergency Management Agency and a county or municipality associated with the training, certification and recertification of an EMS agency dispatch center's calltakers and dispatchers shall be the responsibility of the EMS agency.

 (4) An EMS agency that operates an EMS agency dispatch center shall:

 (i) Establish and maintain policies and procedures to aid in directing the daily operations of its telecommunications staff.

 (ii) Require its calltakers and dispatchers to satisfy the performance standards in 4 Pa. Code § 120d.105 (relating to quality assurance review standards)

 (iii) Have a quality assurance reviewer who is qualified to perform and performs the quality assurance review functions specified in 4 Pa. Code § 120d.104 (relating to time frames and procedures for quality assurance reviews). The quality assurance reviewer shall be a member of the EMS agency's quality improvement committee and that committee shall also be responsible for the quality improvement of the EMS agency dispatch center and shall participate in the county PSAP quality assurance process.

 (iv) Refer to the PSAP in its area any request for emergency EMS for which it is unable to dispatch appropriate EMS resources within the time prescribed by the PSAP.

 (5) References in 4 Pa. Code §§ 120d.104 and 120d.105 to the Pennsylvania Emergency Management Agency, 911 communications centers and remote dispatch points are replaced with the Department and EMS agency dispatch centers for the purpose of this regulation.

 (6) Effective ______ , (Editor's Note: The blank refers to 270 days after the effective date of adoption of this proposed rulemaking.) an EMS agency dispatch center shall use the emergency medical dispatch program used by the 911 emergency communications center of the county in which the EMS agency dispatch center is located.

 (i) Patient management. All aspects of patient management are to be handled by an EMS provider with the level of certification necessary to care for the patient based upon the condition of the patient.

 (j) Use of lights and other warning devices. Ground EMS vehicles may not use emergency lights or audible warning devices unless they do so in accordance with the standards imposed under 75 Pa.C.S. (relating to Vehicle Code). When transporting or responding to a call involving a patient who presents or is in good faith perceived to present a combination of circumstances that may lead to worsened patient outcomes if additional medical intervention were delayed by the amount of time that is estimated to be saved by the use of emergency lights or audible warning devices. Lights and a siren may be used on an ambulance when transporting a patient only when medical intervention is beyond the capabilities of the ambulance crew using available supplies and equipment.

 (k) Weapons and explosives. Weapons and explosives may not be worn by EMS providers or EMSVOs or carried aboard an EMS vehicle. This subsection does not apply to law enforcement officers who are serving in an authorized law enforcement capacity.

 (l) Accident, injury and fatality reporting. An EMS agency shall report to the appropriate regional EMS council, in a form or electronically, as prescribed by the Department, an EMS vehicle accident that is reportable under 75 Pa.C.S. and an accident or injury to an individual that occurs in the line of duty of the EMS agency that results in a fatality or medical treatment by a licensed health care practitioner. The report shall be made within 24 hours after the accident or injury. The report of a fatality shall be made within 8 hours after the fatality.

 (m) Committees. An EMS agency shall have a safety committee and a quality improvement committee that meet at least quarterly.

 (n) EMS provider credentialing. The EMS agency shall maintain a record for 7 years of the EMS agency medical director's assessments and recommendations provided under § 1023.1(a)(1)(vi)—(viii) (relating to EMS agency medical director). An EMS agency may not permit an EMS provider at or above the AEMT level to provide EMS at the EMS provider's certification level if the EMS agency medical director determines that the EMS provider has not demonstrated the knowledge and skills to competently perform the skills within the scope of practice at that level or the commitment to adequately perform other functions relevant to an EMS provider providing EMS at that level. Under these circumstances, an EMS agency may continue to permit the EMS provider to provide EMS for the EMS agency only in accordance with the restrictions as the EMS agency medical director may prescribe. The EMS agency shall notify the Department within 10 days after it makes a decision to allow an EMS provider to practice at a lower level based upon the assessment of the EMS provider's skills and other qualifications by the EMS agency medical director, or a decision to terminate the EMS agency's use of the EMS provider based upon its consideration of the EMS agency medical director's assessment.

 (o) Display of license and registration certificates. The EMS agency shall display its license certificate and the certificate evidencing current registration of its license in a public and conspicuous place in the EMS agency's primary operational headquarters.

 (p) Monitoring compliance. An EMS agency shall monitor compliance with the requirements that the act and this part impose upon the EMS agency and its staff. An EMS agency shall file a written report with the Department if it determines that an EMS provider or EMSVO who is on the staff of the EMS agency, or who has recently left the EMS agency, has engaged in conduct not previously reported to the Department, for which the Department may impose disciplinary sanctions under § 1031.3 or § 1031.5 (relating to discipline of EMS providers; and discipline of EMS vehicle operators). The duty to report pertains to conduct that occurs during a period of time in which the EMS provider or EMSVO is functioning for the EMS agency.

 (q) Policies and procedures. An EMS agency shall maintain written policies and procedures ensuring that each of the requirements imposed under this section, as well as the requirements imposed under §§ 1021.8(b), 1021.41, 1021.42, 1021.64 and 1027.4 and Chapter 1051 (relating to out-of-hospital do-not-resuscitate orders), are satisfied by the EMS agency and its staff. It shall also maintain written policies and procedures addressing infection control, management of personnel safety and the safe operation of EMS vehicles, storage and environmental control of medications, substance abuse in the workplace and the placement and operation of its resources, and ensure that appropriate staff are familiar with these policies and procedures.

§ 1027.4. Medication use, control and security.

 (a) An EMS agency may stock medications as approved by the Department and shall store medications in a temperature-controlled environment, secured in conformance with the Statewide EMS protocols and the EMS agency's policy and procedures on the storage and environmental control of medications. Additional medications may be stocked by an EMS agency as approved by the EMS agency medical director and the Department if the EMS agency uses PHPEs, PHRNs or PHPs.

 (b) The Department will publish at least annually by notice in the Pennsylvania Bulletin a list of medications approved for use by EMS agencies, by EMS provider certification level and a list of medications that an EMS agency is required to stock based upon the type of EMS service it is licensed to provide.

 (c) An EMS agency may procure and replace medications, from a hospital, pharmacy or from a medical supply company, if not otherwise prohibited by law.

 (d) EMS providers, other than a PHP, may administer to a patient, or assist the patient to administer, medications previously prescribed for that patient, as specified in the Statewide EMS protocols or as authorized by a medical command physician. A PHP may administer to a patient, or assist the patient to administer, medication that was previously prescribed for the patient.

 (1) An EMS provider, other than a PHPE, PHRN or PHP, is restricted to administering medications, not previously prescribed for a patient, as permitted by the Statewide EMS protocols.

 (2) A PHPE or PHRN may administer medications, not previously prescribed for a patient, in addition to those permitted by the Statewide EMS protocols, provided the PHPE or PHRN has received approval to do so by the EMS agency medical director, and has been ordered to administer the medication by the medical command physician. A PHP may administer any medication that the PHP has authority to administer by virtue of the PHP's license to practice medicine or osteopathic medicine.

 (e) The EMS agency shall adequately monitor and direct the use, control and security of medications provided to the EMS agency. This includes:

 (1) Ensuring proper labeling and preventing adulteration or misbranding of medications, and ensuring medications are not used beyond their expiration dates.

 (2) Storing medications as required under The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144), and as otherwise required to maintain the efficacy of medications and prevent misappropriation.

 (3) Including in the EMS PCR information as to the administration of medications by patient name, medication identification, date and time of administration, manner of administration, dosage, name of the medical command physician who gave the order to administer the medication and name of person administering the medication.

 (4) Maintaining records of medications administered, lost or otherwise disposed of and records of medications received and replaced.

 (5) Providing the pharmacy, physician or hospital that is requested to replace a medication with a written record of the use and administration or loss or other disposition of the medication, which identifies the patient and includes any other information required by law.

 (6) Ensuring, in the event of an unexplained loss or theft of a controlled substance, that the dispensing pharmacy, physician or hospital has contacted local police or State Police and the Department's Drugs, Devices and Cosmetics Office and has filed a DEA Form 106 with the Federal Drug Enforcement Administration.

 (7) Disposing of medications as required under The Controlled Substance, Drug, Device and Cosmetic Act.

 (8) Arranging for the original dispensing pharmacy, physician or hospital, or its EMS agency medical director, to provide it consultation and other assistance necessary to ensure that it meets the requirements in this section.

 (9) Securing medications in a manner so that only those EMS providers authorized to administer the medications in providing EMS have access to those medications.

§ 1027.5. Statewide EMS response plan.

 An EMS agency may provide an EMS service at a location through which it is licensed to provide that service, less than 24 hours-a-day, 7 days-a-week, as follows:

 (1) Day or time requirements are not applicable to an EMS agency's operation of an air ambulance service.

 (2) A tactical EMS response service shall be available at all times that a law enforcement service with which it is affiliated requests its participation in a tactical law enforcement operation.

 (3) An EMS agency may operate any EMS service less than 24 hours-a-day, 7 days-a-week, out of any location through which it is licensed to provide the service, in accordance with a county-level or broader-level EMS response plan approved by the Department.

§ 1027.6. EMS vehicle fleet.

 (a) Inspection of EMS vehicles. When an applicant for an EMS agency license is inspected, a Department or regional EMS council inspector will inspect each vehicle the applicant intends to operate as an EMS vehicle. If the vehicle satisfies the requirements for the type of EMS vehicle designated by the applicant, and the applicant otherwise satisfies the requirements for licensure and to conduct a service for which the EMS vehicle will be used, the inspector will affix a date stripe, with an inspection and expiration date, to two decals appropriate to that type of EMS vehicle and provide the decals to the applicant. The applicant shall place a decal in a prominent location on each side of the vehicle. The applicant may not operate the vehicle as an EMS vehicle until the applicant is licensed as an EMS agency and it affixes the decals to the EMS vehicle.

 (b) Permanent change. Before operating an additional or permanent replacement EMS vehicle, an EMS agency shall submit an application for amendment of its license to the regional EMS council through which its license application was processed. The EMS agency may not operate that vehicle as an EMS vehicle unless, as described in subsection (a), it is authorized to do so following an inspection of the vehicle and it affixes decals to the vehicle.

 (c) Temporary change. An EMS agency may operate a temporary replacement EMS vehicle without securing prior approval from the Department. It shall submit a temporary change of vehicle form to the regional EMS council through which its license application was processed, by facsimile, e-mail or regular mail before putting the EMS vehicle in service. In the form the EMS agency shall attest to the fact that the EMS vehicle satisfies the requirements for that type of EMS vehicle that are imposed by regulation and notices published in the Pennsylvania Bulletin. Upon submitting a temporary change of vehicle form, the EMS agency may continue to operate the temporary replacement EMS vehicle unless its authority to do so is disapproved by the inspector following an inspection of the EMS vehicle. Upon receiving a temporary change in vehicle form, the regional EMS council shall issue a letter which acknowledges receipt of the temporary change of vehicle form and authorizes the EMS agency to operate the replacement EMS vehicle for 7 days based upon its attestation that the vehicle satisfies all requirements. That time period may be extended by the regional EMS council, by letter.

 (d) Triennial inspections. A Department or regional EMS council inspector will inspect an EMS agency's EMS vehicles when the inspector conducts the inspection of the EMS agency for the triennial registration of the EMS agency's license. If an EMS vehicle satisfies all requirements the inspector will affix a new date stripe to each decal to reflect that the vehicle has satisfied EMS vehicle inspection requirements. If the vehicle does not satisfy the requirements, the inspector will not affix a new date stripe to each decal and the EMS agency may not operate the vehicle as an EMS vehicle unless and until the vehicle is reinspected, satisfies all requirements, and the inspector affixes a new date stripe on each decal.

 (e) Removal of decals. A Department or regional EMS council inspector will require the EMS agency to remove the decals from an EMS vehicle when directed by the Department under § 1027.7(b) (relating to removal of EMS vehicles from operation). An EMS agency shall remove the decals from an EMS vehicle when the EMS agency transfers the title or operation of the EMS vehicle to another entity, other than to enable another EMS agency to operate the EMS vehicle as a temporary replacement vehicle under subsection (c), or when it discontinues use of the vehicle as an EMS vehicle.

 (f) Ambulance requirements. An ambulance must meet the following minimum requirements:

 (1) It must have a patient care compartment that is designed to carry at least one patient on a stretcher that is securely mounted to the ambulance and that enables transportation in both the supine and seated upright positions.

 (2) It must have a patient care compartment that is designed to provide sufficient access to a patient's body to perform and maintain ALS skills, including adequate space for one caregiver to sit superior to the patient's head to perform required ALS airway skills, and other EMS required by the Statewide EMS protocols.

 (3) It must have a design that does not compromise patient safety during loading, unloading or patient transport. It must be equipped with a door that will allow loading and unloading of the patient without excessive maneuvering.

 (4) It must be equipped with permanently installed climate control equipment to provide an environment appropriate for the medical needs of a patient.

 (5) It must have interior lighting adequate to enable medical care to be provided and patient status monitored without interfering with the vehicle operator's vision.

 (6) It must be designed for patient safety so that the patient is isolated from the operator's compartment in a manner that minimizes distractions to the vehicle operator during patient transport and prevents interference with the operator's manipulation of vehicle controls.

 (7) It must be equipped with appropriate patient restraints and with restraints in every seating position within the patient compartment.

 (8) An ALS ambulance used for critical care transports and an air ambulance must be equipped with 110 V electrical output with a minimum of four appropriate outlets within the patient compartment with the ability to operate the vehicle while operating medical equipment using all outlets simultaneously.

 (9) It must have enough space to accommodate the loading, unloading and transport of an infant isolette and permit sufficient access to the infant's entire body to begin and maintain ALS and other treatment modalities within the isolette.

 (10) It must be equipped with two-way radios capable of communication with medical command facilities, receiving facility communications centers, PSAPs and ambulances for the purpose of communicating medical information and assuring the continuity of resources for patient care needs.

 (11) It must carry an oxygen supply that is capable of providing high flow oxygen at more than 25 liters per minute to a patient for the anticipated duration of patient transport.

§ 1027.7. Removal of EMS vehicles from operation.

 (a) When an EMS vehicle manifests evidence of a mechanical or equipment deficiency which poses a significant threat to the health or safety of patients or crew, the EMS agency shall immediately suspend the vehicle from operation. An EMS agency may not operate an EMS vehicle that it has suspended from operation until the deficiency has been corrected.

 (b) When an EMS vehicle, upon examination by the Department or a regional EMS council, manifests evidence of a mechanical or equipment deficiency which poses a significant threat to the health or safety of patients or crew, the EMS agency shall immediately suspend it from operation as directed by the Department. An EMS agency may not operate as an EMS vehicle a vehicle which has been suspended from operation by the Department until the Department has confirmed to the EMS agency that the deficiency has been corrected.

§ 1027.8. Right to enter, inspect and obtain records.

 (a) Upon the request of an employee or agent of the Department during regular and usual business hours, or at other times when that person possesses a reasonable belief that violations of this subpart may exist, an EMS agency or applicant for an EMS agency license shall:

 (1) Produce for inspection records maintained under § 1021.41 (relating to EMS patient care reports).

 (2) Produce for inspection, permit copying and provide within a reasonable period of time as directed by the Department, records that pertain to personnel and their qualifications, staffing, equipment, supplies, and policies and procedures required under § 1027.3 (relating to licensure and general operating standards).

 (3) Permit the person to examine EMS vehicles, equipment and supplies, and security arrangements.

 (b) The Department's representative shall advise the licensee or applicant that the inspection is being conducted under section 8129(h) of the act (relating to emergency medical services agencies) and this subpart.

 (c) Failure of an EMS agency or an applicant for an EMS agency license to produce records or to permit an examination as required by this section is a ground for imposing disciplinary sanctions upon the EMS agency and denying an application for an EMS agency license.

§ 1027.9. Notification of deficiencies to applicants.

 (a) Upon completion of an inspection under an application for a license, registration of a license or an amendment of a license, the inspector shall provide the applicant with an inspection report specifying the results of the inspection.

 (b) If the inspection reveals deficiencies that can be corrected and the inspector determines that the deficiencies warrant a reinspection, the inspector shall give the applicant written notice of the matters to be reinspected and copy the Department on the notice.

 (c) If the type of deficiency requires a plan of correction, the applicant shall have 30 days in which to provide the inspector with a plan to correct the deficiency. If the plan is found to be acceptable by the regional EMS council, the inspector will conduct a reinspection in accordance with the time frame given in the plan of correction.

 (d) If the applicant disagrees with a deficiency cited by the inspector following the inspection or reinspection, or the regional EMS council's rejection of a plan of correction, the applicant shall apprise the Department of the matter in dispute in writing within 10 days of the inspection or rejection of the plan of correction and the Department will resolve the dispute within 30 days of receipt of the written notification.

 (e) The Department will act upon the application within 30 days after the inspection process has been completed, unless the Department requires additional time to complete an investigation of those qualifications of the applicant which cannot, for just cause, be determined through the inspection process.

 (f) Nothing in this section shall be construed to preclude the Department from identifying to the EMS agency statutory or regulatory violations not identified by the inspector, or from requiring the EMS agency to file a plan of correction to correct those deficiencies or taking immediate action to correct those deficiencies, or from taking disciplinary action against an EMS agency for a statutory or regulatory violation that cannot be corrected or for which the Department determines that disciplinary action best serves the public interest.

§ 1027.10. Plan of correction.

 (a) Notification of violation. Upon determining that an EMS agency has violated the act or this chapter, the Department may issue a written notice to the EMS agency specifying the violation. The notice will require the EMS agency to take immediate action to discontinue the violation or to submit a plan of correction, or both, to bring the EMS agency into compliance. If the EMS agency cannot remedy the problem immediately and a plan of correction is therefore required, the Department may direct that the violation be remedied within a specified period of time.

 (b) Response by EMS agency. After receiving the notice of violation, the EMS agency shall do one of the following:

 (1) Comply with the requirements specified in the notice of violation.

 (2) Refuse to comply with one or more of the requirements specified in the notice of violation and apprise the Department of its decision, with an explanation, within the time and manner specified in the notice of violation.

 (3) Comply with the requirements specified in the notice of violation and apprise the Department of its decision, within the time and manner specified in the notice of violation of any violation identified in the notice of violation with which it disagrees, supported by an explanation for its disagreement.

 (c) EMS agency disagreement or refusal to comply. If the EMS agency fails to comply with any of the directives in the notice of violation and responds as required under subsection (b)(2), or disagrees with any of the violations identified and responds as required under subsection (b)(3), the Department will evaluate the explanation provided by the EMS agency to determine whether the response was justified. If the Department determines that the response was justified in whole or part, it will inform the EMS agency and rescind any violation identified or directive given in the notice of violation that the Department determines should not have applied.

 (d) Consequence of failure to comply. An EMS agency's response to a notice of violation under subsection (b)(2) does not act to stay any of the directives in the notice of violation. An EMS agency's failure to comply with a directive in the notice of violation constitutes a ground for discipline if the violation to which the directive relates is found to be true following a hearing.

§ 1027.11. Conditional temporary license.

 When an EMS agency or an applicant for an EMS agency license does not provide service 24 hours-a-day, 7 days-a-week, and does not participate in a county-level or broader level EMS response plan, the Department will issue the EMS agency a conditional temporary license, subject to terms the Department determines to be appropriate, if the Department deems it is in the public interest to do so. The conditional temporary license is valid for 1 year and may be renewed as many times as the Department deems it is in the public interest to do so. If the EMS agency does not agree to the terms under which the Department would grant the EMS agency a conditional temporary license, the Department will take disciplinary action against the EMS agency for failing to either provide service 24 hours-a-day, 7 days-a-week, or participate in a county-level or broader level EMS response plan.

§ 1027.12. Discontinuation or movement of operations or reduction of service.

 An EMS agency shall give at least 90 days advance notice to each appropriate regional EMS council, PSAP and chief executive officer of a political subdivision within its service area, as well as the chief executive officer of each political subdivision outside of its service area that relies upon it for service even if not provided on a routine basis, before it discontinues its operations or providing an EMS service out of any location at which it is licensed to provide that service or reducing the days or hours it provides the service. The EMS agency shall also advertise notice of its intent to discontinue operations or a service, or reduce the days or hours it provides the service, in a newspaper of general circulation in its service area at least 90 days in advance of discontinuing its operations or a service, or reducing the days or hours it provides the service, and shall provide the Department with written notice that it has met these responsibilities at least 90 days in advance of taking action. This section does not apply if the Department revokes, suspends or restricts the EMS agency's license under terms that do not afford the EMS agency the opportunity to comply with this section.

§ 1027.13. Management companies.

 (a) Information required to secure approval. Subject to Department approval, an entity may offer management services to EMS agencies. Management services involve exercising operational or managerial control over an EMS agency or conducting the day-to-day operations of the EMS agency. To secure Department approval, the entity shall provide to the Department, on a form or through an electronic process, as prescribed by the Department, the following information and other information as the Department may require:

 (1) Its name, including a fictitious name it has registered, its mailing address, and a primary contact person and telephone number at which that person can be reached.

 (2) The manner in which the applicant is organized—corporation, partnership, limited liability company, sole proprietorship, and the like.

 (3) A description of the management services it offers.

 (4) The names, titles and summary of responsibilities of persons who will be staffing the entity as officers, directors or other officials, and the same information pertaining to the entity and to its officers, directors or other officials, that an applicant for an EMS provider is required to report under § 1023.21(b)(1) and (2) (relating to general rights and responsibilities).

 (5) A statement attesting to the veracity of the information provided, which shall be signed by the principal official of the entity.

 (b) Updating information. An entity approved by the Department to provide management services shall provide the Department on a form or through an electronic process, as prescribed by the Department, any change in the information provided under subsection (a) within 10 days after the change.

 (c) Approval. After receipt of the information required under subsection (a), the Department will approve an entity to offer management services to EMS agencies, subject to possible disapproval under § 1031.16 (relating to discipline of management companies).

 (d) Registry. The Department will maintain a registry of entities approved by the Department to provide management services to EMS agencies.

 (e) Disclosures to EMS agencies. An entity that has received approval from the Department to offer management services to EMS agencies shall provide the same information to an EMS agency that it provides to the Department under subsection (a)(1)—(4) before it contracts with the EMS agency to provide management services for the EMS agency. The entity shall provide the EMS agency with any change in that information within 10 days after the change, except it shall immediately inform the EMS agency of any suspension or revocation of its approval or condition imposed upon it by the Department under § 1031.16.

 (f) Effective date. The effective date of this section is ______ (Editor's Note: The blank refers to 360 days after the effective date of adoption of this proposed rulemaking.). By ______ , (Editor's Note: The blank refers to 360 days after the effective date of adoption of this proposed rulemaking.) an entity that is under contract with an EMS agency to provide management services for the EMS agency on ______ , (Editor's Note: The blank refers to 360 days after the effective date of adoption of this proposed rulemaking.) shall make the same disclosures to the EMS agency as required in subsection (e).

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Subchapter B. EMS AGENCY SERVICES

Sec.

1027.31.	General standards for providing EMS.
1027.32.	Quick response service.
1027.33.	Basic life support ambulance service.
1027.34.	Advanced life support ambulance service.
1027.35.	Advanced life support squad service.
1027.36.	Critical care transport ambulance service.
1027.37.	Air ambulance service.
1027.38.	Special operations EMS services.

§ 1027.31. General standards for providing EMS.

 Regardless of the type of service through which an EMS agency is providing EMS, the following standards apply to the EMS agency and its EMS providers when functioning as an EMS provider on behalf of an EMS agency, except as otherwise provided in this subchapter:

 (1) An EMS provider who encounters a patient before the arrival of other EMS providers shall attend to the patient and begin providing EMS to the patient at that EMS provider's skill level.

 (2) An EMR may not be the EMS provider who primarily attends to a patient unless another higher level EMS provider is not present or all other EMS providers who are present are attending to other patients.

 (3) Except as set forth in paragraph (2), or unless there are multiple patients and the EMS needs of other patients require otherwise, among EMS providers who are present, an EMS provider who is certified at or above the EMS skill level required by the patient shall be the EMS provider who primarily attends to the patient.

 (4) If a patient requires EMS at a higher skill level than the skill level of the EMS providers who are present, unless there are multiple patients and the EMS needs of other patients require otherwise, an EMS provider who is certified at the highest EMS skill level among the EMS providers who are present shall be the EMS provider who primarily attends to the patient.

 (5) A member of the crew with the highest level of EMS provider certification shall be responsible for the overall management of the EMS provided to the patient or patients by the members of that crew. If more than one member of the crew is an EMS provider above the AEMT level, any of those EMS providers may assume responsibility for the overall management of the EMS provided to the patient or patients by the members of that crew.

 (6) If a crew of an EMS agency service needs additional assistance in attending to the needs of a patient or patients, it shall contact a PSAP to request that assistance.

 (7) Except as otherwise provided in this subchapter, an EMS agency shall operate 24 hours-a-day, 7 days-a-week, each type of service it is licensed to provide at each location it is licensed to operate that service.

 (8) A member of an EMS agency crew who responds to a call in a personal vehicle may not transport in that vehicle medications, equipment or supplies that an EMT is not authorized to use.

§ 1027.32. Quick response service.

 (a) Purpose. An EMS agency that operates a QRS uses EMS providers to respond to calls for EMS and provide EMS to patients before an ambulance arrives.

 (b) Vehicles. A QRS is not required to use a vehicle when responding to a call. If a QRS responds to a call using a vehicle, it may use a vehicle other than an EMS vehicle, such as a bicycle, motorized cart or all-terrain vehicle.

 (c) Staffing. The minimum staffing for a QRS is one EMS provider. If the QRS responds to a call with a BLS squad vehicle or ALS squad vehicle, the minimum staff shall also include an EMSVO, except that only one person is required if the EMSVO is also the EMS provider.

 (d) Providing EMS.

 (1) When a member of an ambulance crew arrives at the scene who is certified at the level for which the patient requires EMS or is a higher-level EMS provider than the EMS provider of the QRS crew exercising primary responsibility for the patient, the member of the QRS crew exercising primary responsibility for the patient shall relinquish that responsibility to that member of the ambulance crew.

 (2) Members of a QRS crew who are present shall follow the direction of the member of the ambulance crew who has assumed responsibility for the overall management of the EMS that is provided to the patient or patients at the scene and leave the scene or continue to provide assistance, as requested by that member of the ambulance crew.

§ 1027.33. Basic life support ambulance service.

 (a) Purpose. An EMS agency that operates a BLS ambulance service employs one or more BLS ambulances staffed by a crew capable of providing medical assessment, observation, triage, monitoring, treatment and transportation of patients who require EMS at or below the skill level of an AEMT.

 (b) Operating at the AEMT level. An EMS agency that chooses to operate a BLS ambulance service that provides EMS at the AEMT level shall apply for Department approval to operate in that manner through its application for a license as an EMS agency or an application to amend its EMS agency license. It shall satisfy equipment, staffing and supply requirements to be able to operate at least one BLS ambulance at the AEMT level. A BLS ambulance is operating at an intermediate ALS level when it is staffed, equipped and supplied to operate at the AEMT level and an AEMT or other provider above the EMT level is providing advanced EMS.

 (c) Staffing.

 (1) The minimum staffing for a BLS ambulance crew when responding to a call to provide EMS and transporting a patient is an EMS provider at or above the EMR level, a second EMS provider at or above the EMT level and an EMSVO, except that only a two-person crew is required if the EMSVO is also one of the EMS providers and an EMS provider above the EMR level is available to attend to the patient during patient transport. Until ______ , (Editor's Note: The blank refers to 2 years after the effective date of section 8133 of the act. Section 8133 of the act is effective 180 days after adoption of this proposed rulemaking.) an ambulance attendant who has not yet secured certification as an EMR may substitute for an EMR.

 (2) If the EMS agency responds to a call with a BLS ambulance operating at an intermediate ALS level, at least one of the EMS providers staffing the crew shall be an AEMT or higher level EMS provider and available to attend to the patient during patient transport.

 (3) Responding ambulance crew members may arrive at the scene separately, but the ambulance shall be fully staffed at or above the required minimum staffing level before transporting a patient.

 (d) Providing EMS when dispatched with higher level crews.

 (1) If a BLS ambulance operating at the BLS or intermediate ALS level and an ALS squad vehicle, ALS ambulance or air ambulance are dispatched to provide EMS for a patient, the following apply:

 (i) BLS ambulance crew members shall begin providing EMS to the patient at their skill levels, including transportation of the patient to a receiving facility if the crew determines transport is needed, until higher level EMS is afforded by the arrival of a higher level EMS provider.

 (ii) Upon the arrival of an EMS provider from the crew of an ALS squad vehicle, ALS ambulance or air ambulance, who is a higher level EMS provider than the highest level EMS provider of the BLS ambulance crew who is present, or who is above the AEMT level, the BLS ambulance crew shall relinquish primary responsibility for the patient to that EMS provider.

 (iii) Upon rendezvousing with an ALS ambulance or air ambulance, the BLS ambulance shall continue transporting the patient or release the patient to be transported by the other ambulance, consistent with the Statewide EMS protocols, as directed by the EMS provider exercising primary responsibility for the patient.

 (iv) The BLS ambulance crew shall reassume primary responsibility for the patient if that responsibility is relinquished back to that crew by the EMS provider of the ALS squad vehicle, ALS ambulance or air ambulance who had assumed primary responsibility for the patient.

 (2) A BLS ambulance and crew may transport from a receiving facility a patient who requires EMS above the skill level at which the ambulance is operating, if the sending or a receiving facility provides a registered nurse, physician assistant or physician to supplement the ambulance crew, that person brings on board the ambulance equipment and supplies to provide the patient with EMS above the EMS level at which the BLS ambulance is operating to attend to the EMS needs of the patient during the transport, and that person attends to the patient during the patient transport.

§ 1027.34. Advanced life support ambulance service.

 (a) Purpose. An EMS agency that operates an ALS ambulance service employs one or more ALS ambulances staffed by a crew capable of providing medical assessment, observation, triage, monitoring, treatment and transportation of patients who require EMS above the skill level of an AEMT.

 (b) Staffing. The minimum staffing for a ALS ambulance crew when responding to a call to provide EMS to a patient who requires EMS above the skill level of an EMT is an EMS provider at or above the EMT level, a second EMS provider above the AEMT level and an EMSVO, except that only a two-person crew is required if the EMSVO is also one of the EMS providers and an EMS provider above the AEMT level is available to attend to the patient during patient transport. Responding crew members may arrive at the scene separately, but the ambulance shall be fully staffed at or above the minimum staffing level before transporting a patient.

 (c) Providing EMS when dispatched with a BLS ambulance. If the crew of both an ALS ambulance and a BLS ambulance are dispatched to provide EMS for a patient, the following shall apply:

 (1) Upon arrival of an EMS provider from the ALS ambulance crew who is a higher level EMS provider than an AEMT or a higher level EMS provider than the highest level EMS provider of the BLS ambulance crew who is present, that EMS provider shall assume primary responsibility for the patient.

 (2) If the patient is assessed by the crew of the ALS ambulance to require EMS above the skill level at which the BLS ambulance is operating, and to require transport to a receiving facility, the EMS provider who is responsible for the overall management of the EMS provided to the patient shall decide, consistent with the Statewide EMS protocols, whether the patient shall be transported by the BLS ambulance or the ALS ambulance. In either event, an appropriately certified member of the ALS ambulance crew shall attend to the patient during the transport. If the BLS ambulance is used to transport the patient, that EMS provider shall use the equipment and supplies on the BLS ambulance, supplemented with the additional equipment and supplies, including medications, from the ALS ambulance after the ALS ambulance rendezvous with the BLS ambulance.

 (3) If at the scene or during patient transport by a BLS ambulance, the EMS provider of the ALS ambulance crew who has assumed primary responsibility for the patient determines that the BLS ambulance is operating at the skill level needed to attend to the patient's EMS needs, consistent with the Statewide EMS protocols, that EMS provider may relinquish responsibility for the patient to the BLS ambulance crew.

 (d) Responding to a call for a patient who requires EMS at or below the AEMT level. When an ALS ambulance is employed to respond to a call to provide EMS to a patient who requires EMS at or below the skill level of an AEMT, the staffing and the responsibilities of the ambulance crew are the same as set forth in § 1027.33 (relating to basic life support ambulance service).

§ 1027.35. Advanced life support squad service.

 (a) Purpose. An EMS agency that operates an ALS squad service employs one or more ALS squad vehicles that transports an EMS provider above an AEMT level, along with equipment and supplies, to rendezvous with an ambulance crew to provide medical assessment, observation, triage, monitoring and treatment of persons who require EMS above the skill level of an EMT.

 (b) Staffing. The minimum staffing for a ALS squad vehicle crew when responding to a call to provide EMS is an EMS provider above the AEMT level and an EMSVO, except that only one person is required if the EMSVO is also the EMS provider.

 (c) Providing EMS when dispatched with a BLS ambulance. If the crew of both an ALS squad vehicle and a BLS ambulance are dispatched to provide EMS for a patient, the following apply:

 (1) Upon arrival of an EMS provider from the ALS squad vehicle who is a higher level EMS provider than the highest level EMS provider of the BLS ambulance crew who is present, or is a higher level EMS provider than an AEMT, that EMS provider shall assume primary responsibility for the patient.

 (2) If the patient is assessed by the crew of the ALS squad vehicle to require EMS above the skill level at which the BLS ambulance is operating, and to require transport to a receiving facility, an appropriately certified member of the ALS squad vehicle shall attend to the patient during the transport by the BLS ambulance. That EMS provider shall use the equipment and supplies on the BLS ambulance, supplemented with the additional equipment and supplies, including medications, from the ALS squad vehicle after the ALS squad vehicle rendezvous with the BLS ambulance.

 (3) If at the scene or during patient transport by a BLS ambulance, the crew of the ALS squad vehicle determines that the BLS ambulance is operating at the skill level needed to attend to the patient's EMS needs, consistent with the Statewide EMS protocols, the EMS provider of the ALS squad vehicle who is responsible for the overall management of the EMS provided to the patient may relinquish responsibility for the patient to the BLS ambulance crew.

§ 1027.36. Critical care transport ambulance service.

 (a) Purpose. An EMS agency that operates a critical care transport ambulance service employs one or more ALS ambulances staffed by a crew capable of providing medical assessment, observation, triage, monitoring, treatment and transportation of patients who require EMS at the skill level needed to attend to and transport critically ill or injured patients between receiving facilities.

 (b) Staffing. The minimum staffing for a critical care transport crew when responding to a call to provide critical care transport is an EMSVO and two EMS providers above the AEMT level with at least one of the EMS providers being a paramedic, PHPE, PHRN or a PHP who has successfully completed a critical care transport educational program approved by the Department. Provided that one of the EMS providers is a paramedic, PHPE, PHRN or a PHP who has successfully completed a critical care transport educational program approved by the Department, another health care provider or providers may substitute for a second EMS provider above the AEMT level to attend to a patient with special medical needs if the EMS agency has submitted to the Department, and received the Department's approval, a plan that provides for substitution to attend to the needs of those patients in accordance with the Department-approved protocol the EMS agency has established for its critical care transport service. Responding crew members may arrive at the scene separately, but the ambulance shall be fully staffed at or above the minimum staffing level before transporting a patient.

 (c) Transport of critical care patient. During patient transport, two EMS providers who satisfy the minimum EMS provider staffing requirement in subsection (b) shall accompany the patient in the patient compartment of the ambulance and be available to attend to the patient during the transport.

 (d) Expanded scope of practice. When providing EMS through a critical care transport ambulance service, the scope of practice of an EMS provider above the AEMT level will be expanded. This expansion will include EMS skills, the use of equipment in addition to those included in the EMS provider's general scope of practice if the EMS provider has received education to perform those skills and use that equipment by having successfully completed a critical care transport educational program approved by the Department. The EMS provider is required to be able to document having received that education and to demonstrate competence in the performance of those skills to the EMS agency medical director. Use of that equipment by that level of EMS provider will be authorized by the Department as published in a notice in the Pennsylvania Bulletin. An EMS provider shall perform these skills as directed by the Statewide EMS protocols applicable to a critical care transport ambulance service or as otherwise directed by a medical command physician.

§ 1027.37. Air ambulance service.

 (a) Purpose. An EMS agency that operates an air ambulance service employs one or more air ambulances staffed by a crew capable of providing medical assessment, observation, triage, monitoring, treatment and transportation of patients who require EMS. An air ambulance should be employed when time to administer definitive care to a patient is of the essence and transportation by air ambulance to a receiving facility able to provide the care is faster than transportation by ground ambulance, or when a patient requires EMS provided by specialized equipment or providers not available on a ground ambulance and the air ambulance can provide this faster than the patient would receive such care at a receiving facility if transported by ground ambulance.

 (b) Staffing. The minimum staffing for an air ambulance crew when responding to a call to transport a patient by air ambulance is a pilot and two EMS providers above the AEMT level, with at least one of the EMS providers being a paramedic, PHPE, PHRN or a PHP who has successfully completed an air ambulance transport educational program approved by the Department. Provided that one of the EMS providers is a paramedic, PHPE, PHRN or a PHP who has successfully completed an air ambulance transport educational program approved by the Department, another health care provider or providers may substitute for a second EMS provider above the AEMT level to attend to a patient with special medical needs if the EMS agency has submitted to the Department, and received the Department's approval, a plan that provides for substitution to attend to the needs of those patients in accordance with the Department-approved protocol the EMS agency has established for its air ambulance service. Responding crew members may arrive at the scene separately, but the ambulance shall be fully staffed at or above the minimum staffing level before transporting a patient.

 (c) Transport of patient. During patient transport, two EMS providers who satisfy the minimum EMS provider staffing requirement in subsection (b) shall accompany the patient in the patient compartment of the ambulance and be available to attend to the patient during the transport.

 (d) Flight requirements.

 (1) An EMS agency's determination regarding whether to accept a flight shall be based solely on availability, weather conditions and safety considerations.

 (2) The crew of an air ambulance shall apprise the dispatching ground PSAP as soon as practical after receiving a dispatch call, its estimated time of arrival at the scene of the emergency. While the air ambulance is enroute to the scene of an emergency, if the crew of the air ambulance believes that the air ambulance and required staff will not be able to arrive at the emergency scene within the estimated time of arrival previously given, the air ambulance crew shall contact the ground PSAP and provide a new estimated time of arrival.

 (e) EMS protocols. In addition to following the Statewide EMS protocols, an EMS agency that operates an air ambulance service may establish and follow EMS protocols that address EMS not covered by the Department's EMS protocols, provided those protocols are approved by the Department. To secure that approval, the EMS agency shall submit the proposed protocols to the medical advisory committee of the regional EMS council through which it submitted its application to be licensed as an EMS agency. That medical advisory committee shall assess the appropriateness of the proposed protocols and then forward the proposed protocols to the Department with its recommendations.

 (f) Expanded scope of practice. When providing EMS through an air ambulance service, the scope of practice of an EMS provider above the AEMT level is expanded. This expansion will include EMS skills and the use of equipment in addition to those included in the EMS provider's general scope of practice if the EMS provider has received education to perform those skills and use that equipment by having successfully completed an air ambulance transport educational program approved by the Department. The EMS provider is required to be able to document having received that education and to demonstrate competency in the performance of those skills to the EMS agency medical director. Use of that equipment by that level of EMS provider will be authorized by the Department as published in a notice in the Pennsylvania Bulletin. An EMS provider shall perform these skills as directed by the Statewide EMS protocols applicable to an air ambulance service or as otherwise directed by a medical command physician.

§ 1027.38. Special operations EMS services.

 (a) Generally. A special operations EMS service provides EMS in austere environments that require specialized knowledge, equipment or vehicles to access a patient or it addresses patient care situations that differ from the routine situations that can be handled by a QRS, ambulance service or ALS squad service, or some combination thereof. Depending upon the type of special operations EMS service and the circumstances presented, a special operations EMS service may be able to meet the EMS needs of the patient by itself, or may need to work with other EMS services to meet the EMS needs of the patient.

 (b) Special provisions. The following apply to special operations EMS services:

 (1) When providing EMS through a special operations EMS service, an EMS provider's scope of practice is expanded to include EMS skills and the use of equipment in addition to those included in the EMS provider's general scope of practice if the EMS provider has received education to perform those skills and use that equipment by having successfully completed a course approved by the Department for that type of special operations EMS service, the EMS provider is able to document having received that education, and the performance of those skills and use of that equipment by that level of EMS provider is authorized by the Department as published in a notice in the Pennsylvania Bulletin. An EMS provider shall perform these skills as directed by the Statewide EMS protocols applicable to that type of special operations EMS service or as otherwise directed by a medical command physician.

 (2) Notwithstanding § 1021.41(a) (relating to EMS patient care reports), when an EMS agency is providing EMS exclusively through a special operations EMS service it shall document patient encounters as follows:

 (i) It shall document every patient encounter on a log that includes the minimum information required by the Department as published in a notice in the Pennsylvania Bulletin, including documentation required by the Statewide EMS protocols for any patient refusing treatment.

 (ii) For any patient transported by ambulance from a special operations EMS incident, it shall complete a written transfer of care form that contains the patient information that is essential for immediate transmission for patient care required under § 1021.41(c), and provide it to the EMS provider on the ambulance who accepts responsibility for the patient.

 (iii) For any patient transported by ambulance from a special operations EMS incident who receives EMS from the special operations EMS service exceeding the scope of practice of an EMT, it shall complete an EMS PCR and otherwise comply with § 1021.41.

 (iv) For any patient not transported by ambulance who refuses EMS or dies while under the care of a special operations EMS service, the special operations EMS service shall complete an EMS PCR and otherwise comply with § 1021.41.

 (3) Notwithstanding § 1027.31(8) (relating to general standards for providing EMS), when an EMS provider at or above the AEMT level is responding as part of a special operations EMS service in a vehicle other than an EMS vehicle, the EMS provider may transport in that vehicle EMS equipment and supplies that an EMT is not authorized to use, provided the EMS agency has adopted policies approved by its EMS agency medical director to ensure the proper storage and security of the equipment and medications, and the EMS provider abides by those policies.

 (4) To facilitate the ability of EMS providers to access and move patients, a special operations EMS service may use modes of transportation at the special operations EMS incident site, such as a bike, golf cart or other motorized vehicle, to transport EMS providers and patients.

 (c) Tactical EMS service.

 (1) Purpose. An EMS agency that provides a tactical EMS service provides EMS support to a law enforcement service to afford a rapid and safe EMS response if a person becomes ill or injured during a tactical law enforcement operation.

 (2) Affiliation. To secure and maintain an EMS agency license that authorizes the EMS agency to operate a tactical EMS service, an EMS agency shall demonstrate that it is affiliated with a law enforcement service operated by a government law enforcement agency or a consortium of government law enforcement agencies.

 (3) Staffing. An EMS agency that provides a tactical EMS service shall be staffed by at least six EMS providers who are above the AEMT level with a minimum of 2 years of experience as an EMS provider above the AEMT level, and who have completed an educational program approved by the Department on tactical EMS operations. The minimum staff when providing EMS support as a tactical EMS service is two EMS providers who meet these standards. All EMS providers who provide EMS for an EMS agency's tactical EMS service shall be 21 years of age or older.

 (4) Weapons. Notwithstanding § 1027.3(h) (relating to licensure and general operating standards), when an EMS provider is responding to a tactical law enforcement operation as part of a tactical EMS service, the EMS provider may carry weapons and other tactical items as otherwise permitted by law and approved by the affiliated law enforcement agency.

 (5) Reporting. The EMS agency shall provide a summary report of a tactical EMS operation response to the regional EMS council assigned to the region in which the tactical EMS service was provided, within 30 days of the tactical EMS operation, on a form or through an electronic process as prescribed by the Department.

 (d) Wilderness EMS service.

 (1) Purpose. An EMS agency that provides a wilderness EMS service provides EMS in the wilderness, backcountry or other wild and uncultivated area to afford an EMS response should a person become ill or injured in that setting.

 (2) Coordination. To secure and maintain an EMS agency license that authorizes the EMS agency to operate a wilderness EMS service, an EMS agency shall demonstrate that it has coordinated with a local, county or State emergency service or services and responds at their request.

 (3) Staffing. An EMS agency that provides a wilderness EMS service shall be staffed by at least six EMS providers who have completed an educational program approved by the Department on wilderness EMS operations. The minimum staff when providing EMS as a wilderness EMS service is two EMS providers at or above the EMT level who meet these standards. EMS providers who provide EMS for a wilderness EMS service shall be 18 years of age or older.

 (4) Reporting. The EMS agency shall provide a summary report of a wilderness EMS operation response to the regional EMS council assigned to the region in which the wilderness EMS service was provided, within 30 days of the wilderness EMS operation, on a form or through an electronic process, as prescribed by the Department.

 (e) Mass-gathering EMS service.

 (1) Purpose. An EMS agency that provides a mass-gathering EMS service provides EMS when there is a large gathering of persons under circumstances such as the following:

 (i) The number of anticipated participants or spectators would overwhelm normal EMS capabilities for the area or local hospital capabilities.

 (ii) The nature of the activity occurring at the mass-gathering site may result in increased risk of injury or illness to spectators or participants.

 (iii) Areas where access to normal EMS operations are limited due to factors such as physical/logistical restrictions in access routes, gathering areas and the number of spectators.

 (iv) Risk analysis has determined that the site of the mass-gathering could be considered a target of opportunity for terrorist activity.

 (2) Coordination. To secure and maintain an EMS agency license that authorizes the EMS agency to operate a mass-gathering EMS service, an EMS agency shall demonstrate that it has coordinated with an EMS agency that operates an ambulance service and other local, county or State emergency services.

 (3) Staffing. An EMS agency that provides mass-gathering EMS service shall be staffed by at least six EMS providers. The minimum staff when providing EMS support as a mass-gathering EMS service is two EMS providers with at least one EMS provider at or above the EMT level.

 (4) Reporting. The EMS agency shall provide a summary report of a mass-gathering event at which it provides EMS to the regional EMS council assigned to the region in which the mass-gathering EMS service was provided, within 30 days of the event, on a form or through an electronic process, as prescribed by the Department.

 (f) Urban search and rescue EMS service.

 (1) Purpose. An EMS agency that provides an urban search and rescue (USAR) EMS service provides EMS at an incident in which patients are entrapped by a structural collapse or other entrapment for an extended period of time.

 (2) Coordination. To secure and maintain an EMS agency license that authorizes the EMS agency to operate a USAR EMS service, an EMS agency shall demonstrate that it has coordinated with a local, county or State emergency service or services and responds at their request.

 (3) Staffing. An EMS agency that provides a USAR EMS service shall be staffed by at least six EMS providers above the level of AEMT who have completed an educational program approved by the Department on USAR EMS operations. The minimum staff when providing EMS as a USAR EMS service is two EMS providers above the AEMT level who meet these standards. EMS providers who provide EMS for a USAR EMS service shall be 18 years of age or older.

 (4) Reporting. The EMS agency shall provide a summary report of a USAR EMS operation response to the regional EMS council assigned to the region in which the USAR EMS service was provided, within 30 days of the USAR EMS operation, on a form or through an electronic process, as prescribed by the Department.

 (g) Extraordinary applications. An EMS agency or an applicant for an EMS agency license may apply to operate under its license a type of special operations EMS service that is not addressed in this chapter. The Department will address each request on an individual basis. It will grant, conditionally grant or deny the request as it deems appropriate to protect the public interest. An EMS agency granted authorization to conduct a special operations EMS service under this subsection shall be subject to any later adopted regulations that apply to that type of special operations EMS service.

 (h) Construction. This section enables an EMS agency that has been licensed to provide a special operations EMS service to hold itself out as being licensed to provide that service and to provide that service in accordance with the requirements in this section. It does not require an EMS agency to be licensed to conduct a special operations EMS service to respond to a call requesting EMS under circumstances in which a special operations EMS service would be appropriate.

Subchapter C. MISCELLANEOUS

Sec.

1027.51.	Stretcher and wheelchair vehicles.
1027.52.	Out-of-State providers.

§ 1027.51. Stretcher and wheelchair vehicles.

 (a) Stretcher vehicle. A stretcher vehicle is a ground vehicle, other than an ambulance, that is commercially used to transport by stretcher a person who does not receive and cannot reasonably be anticipated to require medical assessment, monitoring, treatment or observation by EMS providers during transport, but who, due to the person's condition, requires vehicle transportation on a stretcher or in a wheelchair.

 (b) Wheelchair vehicle. A wheelchair vehicle is a ground vehicle, other than an ambulance, that is commercially used to transport by wheelchair a person who does not receive and cannot reasonably be anticipated to require medical assessment, monitoring, treatment or observation by EMS providers during transport, but who, due to the person's condition, requires vehicle transportation on a stretcher or in a wheelchair.

 (c) Prohibition. An entity may not operate a stretcher or wheelchair vehicle to transport a person who the entity knows or should reasonably know requires medical assessment, monitoring, treatment or observation during transport.

§ 1027.52. Out-of-State providers.

 (a) An entity located or headquartered outside of this Commonwealth, that is not licensed as an EMS agency by the Department, may not engage in the business of providing EMS to patients within this Commonwealth except when dispatched by a PSAP to provide EMS. This is to occur only when a PSAP determines that an EMS agency is unable to respond within a reasonable time or its response is not sufficient to deal with the emergency.

 (b) An entity located or headquartered outside of this Commonwealth, that is not licensed as an EMS agency by the Department, may provide EMS to patients when transporting them from locations outside this Commonwealth to locations within this Commonwealth.

 (c) An entity located or headquartered outside this Commonwealth, which is not an agency of the Federal government, needs to be licensed as an EMS agency by the Department to provide EMS to patients within this Commonwealth other than as described in subsections (a) and (b).

CHAPTER 1029. MEDICAL COMMAND FACILITIES AND RECEIVING FACILITIES

Subchap.

A.	MEDICAL COMMAND FACILITIES
B.	RECEIVING FACILITIES

Subchapter A. MEDICAL COMMAND FACILITIES

Sec.

1029.1.	General provisions.
1029.2.	Operational requirements.
1029.3.	Processing certification and registration applications.
1029.4.	Inspections and investigations.
1029.5.	Plan of correction.
1029.6.	Discontinuation of service.

§ 1029.1. General provisions.

 (a) Certification and registration required. To operate as a medical command facility, a medical unit shall be certified and currently registered as a medical command facility.

 (b) Certification requirements.

 (1) The Department will certify as a medical command facility a facility that was recognized by the Department as a medical command facility immediately prior to ______ (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.).

 (2) The Department will certify other applicants for certification as a medical command facility if the Department is satisfied that the applicant has met the following requirements:

 (i) It is a distinct medical unit operated by a hospital or consortium of hospitals.

 (ii) It has the equipment and personnel needed to provide medical command to and control over EMS providers.

 (iii) It employs a medical command facility medical director.

 (iv) It has adopted policies and procedures to ensure that a medical command physician is available to provide medical command at all times.

 (v) It satisfies the communications, recordkeeping and other requirements imposed under this chapter.

 (c) Certification application. An application for certification as a medical command facility shall be submitted on a form or through an electronic process, as prescribed by the Department, to the regional EMS council exercising responsibility for the EMS region in which the applicant is located. The application form shall solicit information to enable the Department to determine whether the applicant has satisfied the certification requirements under subsection (b).

 (d) Triennial registration. A medical command facility's certification is deemed registered when the certification is issued. Except for a medical command facility certified under subsection (b)(1), a medical command facility's registration of its certification is valid for 3 years. The initial registration of the certification of a medical command facility certified under subsection (b)(1) based upon its prior recognition as a medical command facility will expire when its recognition as a medical command facility would have expired under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)).

 (e) Registration application. A medical command facility shall submit an application for registration of its certification on a form or through an electronic process, as prescribed by the Department, between 60 and 90 days before its current registration expires to the regional EMS council exercising responsibility for the EMS region in which the applicant is located. The application form shall solicit information to enable the Department to determine whether the applicant continues to satisfy the certification requirements under subsection (b)(2).

§ 1029.2. Operational requirements.

 The operational requirements of a medical command facility are as follows:

 (1) It shall continue to satisfy all requirements under § 1029.1 (relating to general provisions).

 (2) It shall satisfy the following communication and recordkeeping requirements:

 (i) Compatibility with regional telecommunication systems plans, if in place.

 (ii) Communication by way of telecommunications equipment/radios with EMS providers providing EMS for an EMS agency within the area in which medical command is exercised.

 (iii) Audio recording of medical command communications or, when medical command is provided at the scene, otherwise documenting medical command sessions.

 (iv) Maintenance of the recording of a medical command session, or documentation of a medical command session when medical command is provided at the scene, for 7 years.

 (v) An appropriate program for training emergency department staff in the effective use of telecommunication equipment.

 (vi) Protocols to provide for prompt response to requests from EMS providers for both radio and telephone medical guidance, assistance or advice.

 (vii) Documentation that each medical command physician has been educated on all updates to Statewide EMS protocols.

 (3) It shall accurately and promptly relay information regarding patients to the appropriate receiving facility.

 (4) It shall adhere to EMS protocols approved by the Department except when a departure is required for good cause.

 (5) It shall establish a process whereby the medical command facility medical director or the director's designee identifies problems to EMS providers and instructs how to correct those problems.

 (6) It shall obtain a contingency agreement with at least one other medical command facility to assure availability of medical command at all times, including during mass casualty situations, natural disasters and declared states of emergency.

 (7) It shall establish internal procedures that comply with the Statewide EMS protocols.

 (8) It shall notify PSAPs, through which it routinely receives requests for medical command, when it will not have a medical command physician available to provide medical command.

 (9) It shall participate in the regional EMS council's quality improvement program.

 (10) It shall employ sufficient administrative support staff to enable the institution to carry out its essential duties, including audits, equipment maintenance, and processing and responding to complaints.

 (11) It shall establish a program of training for medical command physicians, EMS providers and emergency department staff and establish a method to assure that each medical command physician receives education about all updates and changes to the Statewide EMS protocols.

 (12) It shall provide medical command to EMS providers whenever they seek direction.

§ 1029.3. Processing certification and registration applications.

 (a) A regional EMS council that receives an application for medical command facility certification or an application to register that certification shall review the application for completeness. The regional EMS council shall apprise the applicant if the application is incomplete and obtain a completed application from the applicant.

 (b) The regional EMS council shall conduct an onsite inspection of the applying facility to verify information contained within the application and to complete a physical inspection of the medical command area.

 (c) After completing its review, the regional EMS council shall forward a copy of its recommendation to the Department and to the applying facility. If the applying facility disagrees with the recommendation of the regional EMS council, it may submit a written rebuttal to the Department within 10 days of its receipt of the recommendation.

 (d) The Department will review the application, information and recommendation submitted by the regional EMS council and the rebuttal statement, if any, submitted by the applying facility and make a decision within 30 days from the time of its receipt of the regional EMS council's recommendation to grant or deny the application.

 (e) The Department may inspect the facility and gather additional information to aid it in making a decision on the application.

§ 1029.4. Inspections and investigations.

 (a) The Department will conduct inspections of a medical command facility from time to time, as deemed appropriate and necessary, but at least once every 3 years, including when necessary to investigate a complaint or a reasonable belief that a violation of this subchapter may exist. The Department may have a regional EMS council conduct or assist the Department in conducting an inspection or investigation.

 (b) A medical command facility and an applicant for medical command facility certification shall fully respond to an inquiry of the Department or a regional EMS council regarding its compliance with this subchapter and provide them full and free access to examine the facility and its records relating to its operation as a medical command facility.

§ 1029.5. Plan of correction.

 (a) Notification of violation. Upon determining that a medical command facility has violated the act or this subchapter, the Department may issue a written notice to the medical command facility specifying the violation or violations. The notice will require the medical command facility to take immediate action to discontinue the violation or violations or to submit a plan of correction, or both, to bring the medical command facility into compliance. If the medical command facility cannot remedy the problem immediately and a plan of correction is therefore required, the Department may direct that the violation be remedied within a specified period of time.

 (b) Response by medical command facility. After receiving the notice of violation or violations, the medical command facility shall do one of the following:

 (1) Comply with the requirements specified in the notice.

 (2) Refuse to comply with one or more of the requirements specified in the notice and apprise the Department of its decision, with an explanation, within the time and manner specified in the notice.

 (3) Comply with the requirements specified in the notice and apprise the Department of its decision, within the time and manner specified in the notice of any violation identified in the notice with which it disagrees, supported by an explanation for its disagreement.

 (c) Medical command facility disagreement or refusal to comply. If the medical command facility fails to comply with any of the directives in the notice and responds as required under subsection (b)(2), or disagrees with any of the violations identified and responds as required under subsection (b)(3), the Department will evaluate the explanation provided by the medical command facility to determine whether the response was justified. If the Department determines that the response was justified in whole or part, it will inform the medical command facility and rescind any violation identified or directive given in the notice that the Department determines should not have applied.

 (d) Consequence of failure to comply. A medical command facility's response to a notice under subsection (b)(2) does not act to stay any of the directives in the notice. A medical command facility's failure to comply with a directive in the notice constitutes a ground for discipline if the violation to which the directive relates is found to be true following a hearing.

§ 1029.6. Discontinuation of service.

 A medical command facility may not discontinue medical command operations without providing 90 days advance written notice to the Department, regional EMS councils responsible for regions in which the medical command facility routinely provides medical command and EMS agencies for which it routinely provides medical command. A medical command facility shall advertise notice of its intent to discontinue service as a medical command facility in a newspaper of general circulation in its service area at least 90 days in advance of discontinuing service as a medical command facility.

Subchapter B. RECEIVING FACILITIES

Sec.

1029.21.

Receiving facilities.

§ 1029.21. Receiving facilities.

 (a) General requirements. A receiving facility shall be a fixed location, with an organized emergency department, including a physician educated to manage cardiac, trauma, pediatric, obstetrics, medical behavioral and all-hazards emergencies. A physician who satisfies these requirements shall be present in the facility 24 hours-a-day, 7 days-a-week.

 (b) Patients with special needs. Patients with special needs, particularly those with time-sensitive illnesses, who need to be transported to a receiving facility shall be transported to a specialty receiving facility consistent with the Statewide EMS protocols. The Department will maintain, publish in the Pennsylvania Bulletin and update as appropriate a list of the following specialty receiving facilities:

 (1) Trauma centers, as well as trauma facilities in adjacent states accredited by an accrediting body similar to the Trauma Foundation, appropriate for adult and pediatric patients with serious trauma.

 (2) Receiving facilities appropriate for patients suspected to require percutaneous coronary intervention.

 (3) Receiving facilities appropriate for patients with symptoms of suspected acute stroke.

 (4) Receiving facilities appropriate for patients with suspected serious burns.

 (5) Receiving facilities appropriate for other patients with special needs as described in the Statewide EMS protocols.

 (c) Transports to receiving facilities. Unless directed otherwise by a medical command physician, if patient transport by ambulance is required for additional care that has not been prearranged, an ambulance must transport the patient to a receiving facility or other facility as the Department has designated in the Statewide EMS protocols.

 (d) Confirmation of receiving patient. When a patient has been transported to a receiving facility, the receiving facility shall acknowledge in writing that it has received the patient if the transporting ambulance crew requests that acknowledgement.

CHAPTER 1031. COMPLAINTS, DISCIPLINARY ACTIONS, ADJUDICATIONS AND APPEALS

Sec.

1031.1.	Administrative and appellate procedure.
1031.2.	Complaints and investigations.
1031.3.	Discipline of EMS providers.
1031.4.	Reinstatement of revoked EMS provider certification.
1031.5.	Discipline of EMS vehicle operators.
1031.6.	Emergency suspension of EMS provider and EMS vehicle operator certifications.
1031.7.	Discipline of EMS instructors.
1031.8.	Discipline of medical command physicians and medical command facility medical directors.
1031.9.	Automatic suspension for incapacity.
1031.10.	Discipline of EMS agencies.
1031.11.	Discipline of medical command facilities.
1031.12.	Discipline of EMS educational institutes.
1031.13.	Discipline of providers of EMS continuing education.
1031.14.	Civil money penalty for practicing without a license or certification.
1031.15.	Discipline of vendors of EMS PCR software.
1031.16.	Discipline of management companies.

§ 1031.1. Administrative and appellate procedure.

 (a) Administrative proceedings. Except as otherwise provided in this chapter, the Department will hold hearings and issue adjudications for proceedings conducted under the act and this subpart in accordance with 2 Pa.C.S. (relating to administrative law and procedure) and will conduct those proceedings under 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).

 (b) Rules supplementing the General Rules of Administrative Practice and Procedure.

 (1) Formal administrative proceedings on an application for a license, certification, registration or accreditation, or to pursue disciplinary sanctions other than an emergency suspension, will be initiated by an order to show cause issued by the Bureau.

 (2) When responding to an order to show cause, a respondent shall aver, in new matter, matters in defense or mitigation of the charges which are not averred in the answer to the averments in the order to show cause, provided the respondent is given written notice of the respondent's responsibility to do so.

 (3) Except for good cause shown, such as for the purpose of impeachment, neither the Bureau nor the respondent may present evidence at a hearing in support of matters not pled, nor may a respondent raise a defense at a hearing that has not been pled in the respondent's answer or new matter to the order to show cause.

 (4) A request for a continuance shall be filed in writing at least 10 days prior to the date of the hearing. This requirement will be waived only upon a showing of good cause. If a respondent has not retained counsel, a request for a continuance on the day of the hearing to retain counsel will not be considered as good cause for the granting of a continuance.

 (5) If an interpreter is required, a request for an interpreter shall be filed in writing at least 30 days prior to the date of the hearing.

 (c) Judicial appeals. Department adjudications issued under the act and this chapter may be appealed to the Commonwealth Court under 42 Pa.C.S. § 763 (relating to direct appeals from government agencies).

§ 1031.2. Complaints and investigations.

 (a) Filing a complaint. A person may file with the Department a complaint about a violation of the act or this part by an individual or entity regulated by the Department under the act or an individual or entity believed to have provided EMS or have engaged in any other activity for which some type of authorization under the act or this subpart is required, without that individual or entity having secured a certification, license or other authorization from the Department to engage in that activity as required by the act and this subpart.

 (b) Filing office. The complaint shall be filed with the regional EMS council that serves the EMS region where the conduct occurred. The regional EMS council shall provide the Bureau with a copy of the complaint. A complaint concerning the conduct of a regional EMS council shall be filed directly with the Bureau.

 (c) Status of complainant. If a person files a complaint seeking to have the Department impose a disciplinary or corrective measure under this chapter, the Department's action in the handling of the complaint will be on behalf of the Commonwealth to determine whether there has been a violation of a statutory or regulatory requirement over which the Department has jurisdiction under the act.

 (d) Processing a complaint. Upon receipt of a complaint filed under this section, the Bureau will assess whether the Department has jurisdiction over the matter about which the complaint is filed. If the matter is within the Department's jurisdiction and an investigation is needed, the Bureau will investigate the complaint or assign the complaint to a regional EMS council or other appropriate entity to investigate. Unless the Bureau determines that disclosure to the individual or entity about whom the complaint has been filed will compromise the investigation or would be inappropriate for some other reason, the investigation will be initiated by providing that individual or entity with a copy of the complaint and requesting a response. If the matter is not within the Department's jurisdiction to address, the Bureau will advise the person who filed the complaint and refer the complainant to another agency if the Bureau believes that the matter about which the complaint has been filed may be within the other agency's jurisdiction.

 (e) Notification of results of investigation. When an investigation is completed, the Bureau will notify the complainant of the general results of the investigation of the matter about which the complaint was filed. This notification does not include providing the complainant with a copy of any document collected or prepared during the course of the investigation. The Bureau will also provide the same information to the individual or entity about whom the complaint was filed if the individual or entity was officially apprised of the complaint or investigation. If the Department is considering taking disciplinary action against the individual or entity, notification may occur when a disciplinary decision is reached or when disciplinary charges are filed.

§ 1031.3. Discipline of EMS providers.

 (a) Grounds for discipline. The Department may discipline or impose corrective measures on an EMS provider or an applicant for EMS provider certification for one or more of the following reasons:

 (1) Having a lack of physical or mental ability to provide adequate EMS, with reasonable accommodations if the person has a disability.

 (2) Deceptively or fraudulently procuring or representing certification or registration credentials, or making misleading, deceptive or untrue representations to secure or aid or abet another person to secure a certification, license, registration or other authorization issued under this subpart.

 (3) Engaging in willful or negligent misconduct in providing EMS or engaging in practice beyond the scope of certification authorization without legal authority to do so.

 (4) Abusing or abandoning a patient.

 (5) Rendering EMS while under the influence of alcohol, illegal drugs or the knowing abuse of legal drugs.

 (6) Operating an emergency vehicle in a reckless manner or while under the influence of alcohol, illegal drugs or the knowing abuse of legal drugs.

 (7) Disclosing medical or other information about a patient when prohibited by Federal or State law.

 (8) Willfully preparing or filing a false medical report or record or inducing another person to do so.

 (9) Destroying a medical report or record required to be maintained.

 (10) Refusing to render EMS because of a patient's race, sex, creed, national origin, sexual preference, age, handicap or medical problem or refusing to render emergency medical care because of a patient's financial inability to pay.

 (11) Failing to comply with Department-approved EMS protocols.

 (12) Failing to comply with reporting requirements imposed by the act or this subpart.

 (13) Practicing without the current registration of a certification.

 (14) Being convicted of a felony, a crime related to the practice of the EMS provider or a crime involving moral turpitude.

 (15) Willfully falsifying or failing to prepare an EMS PCR or complete details on an EMS PCR.

 (16) Misappropriating drugs or EMS agency property.

 (17) Having a certification or other authorization to practice a profession or occupation revoked, suspended or subjected to other disciplinary sanction.

 (18) Violating, aiding or abetting another person to violate a duty imposed by the act, this subpart or an order of the Department previously entered in a disciplinary proceeding.

 (19) Based upon a finding of misconduct by the relevant Federal or State agency, having been excluded from a Federal or State health care program or having had equity or capital stock or profits of an entity equal to 5% or more of the value of the property or assets of the entity when it was excluded from a Federal or State health care program.

 (20) Any other reason as determined by the Department that poses a threat to the health and safety of the public.

 (b) Types of discipline authorized. If disciplinary action or corrective action is appropriate under subsection (a), the Department may:

 (1) Deny an application for certification or registration of the certification.

 (2) Issue a public reprimand.

 (3) Revoke, suspend, limit or otherwise restrict the certification.

 (4) Require the person to take refresher or other educational courses.

 (5) Impose a civil money penalty not exceeding $1,000 for each incident in which the EMS provider engages in conduct that constitutes a basis for discipline.

 (6) Stay enforcement of a suspension, revocation or other discipline and place the individual on probation with the right to vacate the probationary order for noncompliance.

 (c) Denial of registration. The Bureau will not deny a registration of an EMS provider certification without giving the EMS provider prior notice of the reason for the denial and providing an opportunity for a hearing. If the reason for the denial is the failure of the EMS provider to present prima facie evidence that the continuing education or examination requirement for registration has been satisfied, the opportunity for a hearing may occur after the prior registration has expired.

§ 1031.4. Reinstatement of revoked EMS provider certification.

 (a) Petition for reinstatement. A person whose EMS provider certification has been revoked may petition the Department for allowance to apply for reinstatement of the revoked certification no earlier than 5 years after the effective date of the revocation. The petition must aver facts to establish that the petitioner has been rehabilitated to the extent that issuing that person a reinstatement of the revoked certification would not be detrimental to the public interest. In assessing the public interest, the Department will weigh the facts that tend to show that the petitioner has been rehabilitated against the Department's duty to maintain public confidence in its ability to regulate EMS providers, deter other EMS providers from engaging in conduct similar to that which resulted in the revocation and protect persons who may require EMS.

 (b) Department action on the petition.

 (1) The Department will deny a petition for allowance to apply for reinstatement, without conducting a hearing, if it accepts as true all facts averred and it concludes that those facts fail to establish that the petitioner has been rehabilitated to the extent that reinstatement of the revoked certification would not be detrimental to the public interest.

 (2) The Department may grant or hold a hearing on a petition for allowance to apply for reinstatement if it concludes that the facts averred in the petition, if true, establish a prima facie case that the petitioner has been rehabilitated to the extent that reinstatement of the revoked certification would not be detrimental to the public interest.

 (c) Grant of petition for reinstatement. If the Department grants the petition, the petitioner shall repeat the educational program and the certification examinations that are required for the EMS provider certification the petitioner is seeking to reinstate and shall satisfy all other requirements for that certification that exist at the time the petitioner files an application for reinstatement after having successfully completed that education and the examinations.

 (d) Denial of petition for reinstatement. If the Department denies the petition, the petitioner may not again petition the Department for allowance to apply for reinstatement of the revoked certification until 1 year has expired from the date of the denial.

§ 1031.5. Discipline of EMS vehicle operators.

 (a) Grounds for discipline. The Department may discipline or impose corrective measures on an EMSVO or an applicant for EMSVO certification for one or more of the following reasons:

 (1) Having a lack of physical or mental ability to operate an EMS vehicle, with reasonable accommodations if the person has a disability.

 (2) Deceptively or fraudulently procuring or representing certification or registration credentials, or making misleading, deceptive or untrue representations to secure a certification or registration.

 (3) Operating an emergency vehicle in a reckless manner or while under the influence of alcohol, illegal drugs or the knowing abuse of legal drugs.

 (4) Having a driver's license suspended in any jurisdiction due to the use of alcohol or drugs or a moving traffic violation.

 (5) Operating a ground EMS vehicle without a driver's license or while a driver's license is suspended.

 (6) Being convicted of a felony or a crime involving moral turpitude.

 (7) Failing to report a criminal conviction that the applicant or EMSVO is required to report or failing to report the suspension of a driver's license due to the use of alcohol or drugs or a moving traffic violation.

 (8) Any other reason as determined by the Department that poses a threat to the health and safety of the public.

 (b) Types of discipline authorized. If disciplinary or corrective action is appropriate under subsection (a), the Department may:

 (1) Deny an application for certification or registration of the certification.

 (2) Issue a public reprimand.

 (3) Revoke or suspend the certification.

 (4) Impose conditions for lifting a suspension.

 (c) Automatic suspension. An EMSVO certification shall be automatically suspended for 4 years if an EMSVO is convicted of a criminal offense that involves driving under the influence of alcohol or drugs, and for 2 years if the EMSVO is convicted of a criminal offense that involves reckless driving or had a driver's license suspended due to the use of drugs or alcohol or a moving traffic violation.

§ 1031.6. Emergency suspension of EMS provider and EMS vehicle operator certifications.

 (a) Issuance of emergency suspension. The Department will issue an order suspending an EMS provider or EMS vehicle operator certification, without a hearing, if based upon evidence received that appears to be credible the Department determines that the person is a clear and immediate danger to the public health and safety.

 (b) Notice and preliminary hearing. Notice of the emergency suspension will include a written statement of the factual allegations upon which the determination is based. Unless an extension of time is requested by the EMS provider or EMS vehicle operator, within 30 days after an order under subsection (a) is issued, the Department shall conduct a preliminary hearing to determine whether there is a prima facie case supporting the emergency suspension. The EMS provider or EMS vehicle operator may be present at the preliminary hearing and may be represented by counsel, cross-examine witnesses, inspect physical evidence, call witnesses and offer testimony and other evidence to rebut the prima facie case. If and when the Department determines that the evidence does not establish a prima facie case that the EMS provider or EMS vehicle operator is a clear and immediate danger to the public health and safety, the Department will immediately issue an order lifting the suspension.

 (c) Beginning of formal disciplinary proceedings. After issuing an order under subsection (a), the Department shall begin formal disciplinary action under § 1031.3 or § 1031.5 (relating to discipline of EMS providers; and discipline of EMS vehicle operators).

 (d) Duration of emergency suspension if prima facie case is established. If the Department determines that a prima facie case supporting the emergency suspension is established at the preliminary hearing, the emergency suspension shall remain in effect, but no longer than 180 days unless agreed upon by the parties.

§ 1031.7. Discipline of EMS instructors.

 (a) Grounds for discipline. The Department may discipline or impose corrective measures on a certified EMS instructor, or an applicant for certification as an EMS instructor, for one or more of the following reasons:

 (1) Any reason an EMS provider may be disciplined under § 1031.3 (relating to discipline of EMS providers).

 (2) Providing instruction while under the influence of alcohol or illegal drugs or the knowing abuse of legal drugs.

 (3) Failing to perform a duty imposed upon an EMS instructor under this subpart.

 (4) Any other reason as determined by the Department that poses a threat to the health and safety of students.

 (b) Types of discipline authorized. If disciplinary action or corrective action is appropriate under subsection (a), the Department may:

 (1) Deny an application for certification.

 (2) Issue a public reprimand.

 (3) Revoke, suspend, limit or otherwise restrict the certification.

 (4) Impose a civil money penalty not exceeding $1,000 for each incident in which the EMS instructor engages in conduct that constitutes a basis for discipline.

 (5) Stay enforcement of a suspension, revocation or other discipline and place the individual on probation with the right to vacate the probationary order for noncompliance.

§ 1031.8. Discipline of medical command physicians and medical command facility medical directors.

 (a) Grounds for discipline. The Department may discipline or impose corrective measures on a medical command physician or medical command facility medical director for the following reasons:

 (1) Violating a responsibility imposed on the physician by § 1023.2 or § 1023.3 (relating to medical command physician; and medical command facility medical director).

 (2) Without good cause, failing to comply with an EMS protocol established or approved by the Department.

 (b) Types of discipline authorized. If disciplinary action or corrective action is appropriate under subsection (a), the Department may:

 (1) Deny the application for a certification.

 (2) Issue a public reprimand.

 (3) Revoke, suspend, limit or otherwise restrict or condition the certification.

 (4) Impose a civil money penalty not exceeding $1,000 for each incident in which the physician engages in conduct that constitutes a basis for discipline.

 (5) Stay enforcement of any suspension, revocation or other discipline and place the individual on probation with the right to vacate the probationary order for noncompliance.

§ 1031.9. Automatic suspension for incapacity.

 The Department will automatically suspend a certification issued under this subpart upon receiving a certified copy of court records establishing that the person has been adjudicated as incapacitated under 20 Pa.C.S. § 5511 (relating to petition and hearing; independent evaluation) or an equivalent statutory provision, and will lift the suspension upon receiving a certified copy of court records establishing that the person has regained capacity under 20 Pa.C.S. § 5517 (relating to adjudication of capacity and modification of existing orders) or an equivalent statutory provision.

§ 1031.10. Discipline of EMS agencies.

 (a) Discipline of EMS agencies. The Department may discipline an EMS agency or an applicant for an EMS agency license for one or more of for the following reasons:

 (1) Violating a requirement of the act or a regulation adopted under the act.

 (2) Failing to submit a plan of correction acceptable to the Department to correct a violation cited by the Department or failing to comply with a plan of correction accepted by the Department.

 (3) Refusing to accept a conditional provisional license properly sought by the Department or to abide by its terms.

 (4) Engaging in fraud or deceit in obtaining or attempting to obtain a license.

 (5) Lending its license or, except as authorized by the Department in acting upon the license application or an application to amend the license, enabling another person to manage or operate the EMS agency or any service the EMS agency is licensed to provide.

 (6) Engaging in incompetence, negligence or misconduct in operating the EMS agency or in providing EMS to patients.

 (7) Using the license of another or in any way knowingly aiding or abetting the improper granting of a license, certification, accreditation or other authorization issued under the act.

 (8) Failing to meet or continue to meet applicable licensure standards.

 (9) The EMS agency is not a responsible person or is not staffed by responsible persons and refuses to remove from its staff the irresponsible person or persons when directed to do so by the Department.

 (10) Being convicted of a felony or a crime involving moral turpitude or related to the practice of the EMS agency.

 (11) Making misrepresentations in seeking funds made available through the Department.

 (12) Refusing to render EMS because of a patient's race, sex, creed, national origin, sexual preference, age, handicap, medical problem or refusing to respond to an emergency and render EMS because of a patient's financial inability to pay.

 (13) Violating an order previously issued by the Department in a disciplinary matter.

 (b) Types of discipline authorized. If disciplinary action is appropriate under subsection (a), the Department may:

 (1) Deny an application for a license.

 (2) Issue a public reprimand.

 (3) Revoke, suspend, limit or otherwise restrict the license.

 (4) Impose a civil money penalty not exceeding $5,000 for each incident in which the EMS provider engages in conduct that constitutes a basis for discipline.

 (5) Stay enforcement of a suspension, revocation or other discipline and place the EMS agency on probation with the right to vacate the probationary order for noncompliance.

§ 1031.11. Discipline of medical command facilities.

 (a) Discipline of medical command facilities. The Department may discipline a medical command facility or an applicant for a medical command facility certification for one or more of the following reasons:

 (1) Submitting a fraudulent or deceptive application for certification or registration of the certification.

 (2) Violating a requirement in § 1029.1 or § 1029.2 (relating to general provisions; and operational requirements).

 (3) Refusing to permit an inspection or to respond to an inquiry as required under § 1029.4 (relating to inspections and investigations).

 (4) Failing to comply, without just cause, with an EMS protocol approved by the Department.

 (5) Failing to submit a plan of correction acceptable to the Department to correct a violation cited by the Department or failing to comply with a plan of correction accepted by the Department.

 (b) Types of discipline authorized. If disciplinary action is appropriate under subsection (a), the Department may:

 (1) Deny an application for a certification.

 (2) Issue a public reprimand.

 (3) Revoke, suspend, limit or otherwise restrict or condition the certification.

 (4) Impose a civil money penalty not exceeding $5,000 for each act that constitutes a basis for discipline.

 (5) Stay enforcement of a suspension, revocation or other discipline and place the medical command facility on probation with the right to vacate the probationary order for noncompliance.

§ 1031.12. Discipline of EMS educational institutes.

 The Department may deny, withdraw or condition the accreditation of an EMS training institute for one or more of the following reasons:

 (1) Failure to satisfy the responsibilities imposed upon it under §§ 1025.1—1025.3 (relating to accreditation and operational requirements of EMS educational institutes; accreditation process; and advertising).

 (2) An absence of students in the program for 2 consecutive years.

 (3) Submission of a fraudulent or deceptive application for accreditation.

§ 1031.13. Discipline of providers of EMS continuing education.

 If a continuing education sponsor or an applicant for accreditation as a continuing education sponsor fails to satisfy the requirements in §§ 1025.21—1025.23 (relating to accreditation of sponsors of continuing education; responsibilities of continuing education sponsors; and advertising) or submits a fraudulent or deceptive application for accreditation, the Department may:

 (1) Deny or withdraw its accreditation.

 (2) Downgrade its accreditation status to provisional accreditation, subject to withdrawal if deficiencies are not resolved within a time period prescribed by the Department.

 (3) Withdraw approval of a continuing education course applicable to any future presentation of the course.

§ 1031.14. Civil money penalty for practicing without a license or certification.

 (a) Operating an EMS agency without a license. The Department may impose a civil money penalty of up to $5,000 per day upon a person who owns or operates an EMS agency in this Commonwealth without having a license to operate that EMS agency.

 (b) Practicing as an EMS provider without a certification. The Department may impose a civil money penalty of up to $1,000 per day upon a person who provides EMS without an EMS provider's certification or other legal authority to provide EMS.

§ 1031.15. Discipline of vendors of EMS PCR software.

 The Department may assess a vendor of EMS PCR software a civil money penalty of up to $5,000 for each day a vendor violates a duty imposed by § 1021.43(b) or (d) (relating to vendors of EMS patient care reports).

§ 1031.16. Discipline of management companies.

 (a) The Department may deny, withdraw or condition the approval of an entity to offer management services for one or more of the following reasons:

 (1) The entity is not a responsible person.

 (2) Persons having a substantial ownership interest in the entity are not responsible persons.

 (3) The entity will not be staffed by or conduct its activities through responsible persons.

 (4) The entity refuses to provide the Department with records or information reasonably requested by the Department to make a determination regarding paragraphs (1)—(3).

 (5) The entity conducts the operation or managerial control of an EMS agency, or conducts the day-to-day operations of the EMS agency, in a manner that subjects the EMS agency to possible disciplinary action under § 1031.10 (relating to discipline of EMS agencies).

 (6) The entity violates a requirement of the act or a regulation adopted under the act that is applicable to the entity.

 (7) Engaging in fraud or deceit in obtaining or attempting to obtain or maintain Department approval.

 (b) For purposes of subsection (a):

 (1) A responsible person is a person who has not engaged in an act contrary to justice, honesty or good morals which indicates that the person is likely to betray the public trust in managing the operation of the EMS agency, or is a person who has engaged in this conduct but has been rehabilitated and is not likely to again betray the public trust.

 (2) A person has a substantial ownership in the entity if the person has equity in the capital, stock or the profits of the applicant equal to 5% or more of the property or assets of the applicant.

 (3) A person staffs an entity that manages an EMS agency if the person manages activity integral to the operation of the EMS agency.

CHAPTER 1033. SPECIAL EVENT EMS

Sec.

1033.1.	Special event EMS planning requirements.
1033.2.	Administration, management and medical direction requirements.
1033.3.	Special event EMS personnel and capability requirements.
1033.4.	Onsite facility requirements.
1033.5.	Communications system requirements.
1033.6.	Requirements for educating event attendees regarding access to EMS.
1033.7.	Special event report.

§ 1033.1. Special event EMS planning requirements.

 (a) Procedure for obtaining required plan approval. The entity responsible for the management and administration of a special event may submit a special event EMS plan to the Department, through the regional EMS council assigned responsibility for the region in which the special event is to occur, to secure a determination from the Department as to whether the plan is adequate to address the EMS needs presented by a special event or a series of special events conducted at the same location.

 (1) The applicant shall submit its plan at least 90 days prior to the date of the first day of the event.

 (2) The Department will approve or disapprove a special event EMS plan within 60 days after a complete plan is filed with the regional EMS council.

 (3) The Department's approval of a special event EMS plan will be for the special event or series of special events in a calendar year, as identified in the plan. The entity shall submit a new special event EMS plan to secure Department approval of a plan for a special event or series of special events in a subsequent calendar year.

 (b) Plan content. The special event EMS plan must contain the following information:

 (1) The type and nature of event, location, length and anticipated attendance.

 (2) Identification of sponsoring organization.

 (3) The name and qualifications of the special event EMS medical director and the special event EMS director.

 (4) A listing of all EMS agencies that will be involved, the type of EMS service each EMS agency will provide and the number and level of certification of EMS providers each EMS agency will provide, as well as the number and type of health care practitioners who are not participating on behalf of an EMS agency, including EMS providers who are not participating on behalf of an EMS agency, who will be involved.

 (5) The type and quantity of EMS vehicles and other vehicles, equipment and supplies to be utilized by each EMS agency that will be involved.

 (6) A written agreement with each EMS agency that has agreed to participate, in which the EMS agency identifies the type of EMS service, the number of EMS providers by certification level, the vehicles, the equipment and supplies it will provide.

 (7) A description of the onsite treatment facilities including maps of the special event site.

 (8) A description of the special event emergency medical communications capabilities.

 (9) A risk assessment for the event, and a plan for responding to a possible disaster or mass casualty incident at the event site, including a plan for emergency evacuation of the event site.

 (10) A plan for educating event attendees regarding EMS system access and specific hazards, such as severe weather.

 (11) Measures that have and will be taken to coordinate EMS for the special event or events with local emergency care services and public safety agencies—such as EMS, police, fire, rescue and hospital agencies or organizations.

 (c) Plan approval. To secure Department approval of a special event EMS plan, the applicant shall satisfy the requirements in this chapter.

§ 1033.2. Administration, management and medical direction requirements.

 (a) Special event EMS director. EMS provided at a special event shall be supervised by a special event EMS director.

 (1) Responsibilities. The responsibilities of the special event EMS director include:

 (i) Preparing a plan under § 1033.1 (relating to special event EMS planning requirements).

 (ii) Managing the delivery of special event EMS.

 (iii) Ensuring implementation of the EMS coordination measures contained in the special event EMS plan.

 (iv) Ensuring that a record is kept that lists the individuals that requested or received EMS and the disposition of each case, including identification of the transporting EMS agency and ambulance, and the receiving facility, if the individual was transported to a receiving facility.

 (2) Qualifications. A special event EMS director shall be experienced in the administration and management of EMS at the level of EMS provided for in the special event EMS plan.

 (b) Special event EMS medical director.

 (1) Responsibilities. The responsibilities of a special event EMS medical director include:

 (i) Ensuring that each EMS provider provided by an EMS agency that is used under the special event EMS plan has been appropriately credentialed by the provider's EMS agency medical director to provide EMS at the level required in the plan.

 (ii) Ensuring that if onsite medical command is provided, that it be provided through a medical command facility and that medical command communications are documented.

 (iii) Ensuring that equipment and medications are appropriately stored and secured.

 (iv) Reviewing with the EMS agency medical directors for the EMS agencies involved, quality improvement issues related to the special event.

 (v) Ensuring that adequate EMS PCRs and records are maintained for patients who receive EMS during the special event.

 (2) Qualifications. A special event EMS medical director shall be an EMS agency medical director or satisfy the standards for being an EMS agency medical director in § 1023.1(b) (relating to EMS agency medical director) without serving as an EMS agency medical director.

§ 1033.3. Special event EMS personnel and capability requirements.

 (a) Special event EMS providers shall be certified at appropriate levels based on the level of EMS approved by the Department in the special event EMS plan.

 (b) One ambulance shall be stationed onsite at a special event if the event is expected to involve the presence of between 5,000 and 25,000 persons at any one time.

 (c) Two ambulances shall be stationed onsite at a special event if the event is expected to involve the presence of more than 25,000 but less than 55,000 persons at any one time.

 (d) Three ambulances shall be stationed onsite at a special event if the event is expected to involve the presence of more than 55,000 persons at any one time.

 (e) Sufficient EMS providers shall be available to assure the availability of EMS to persons present at the special event.

§ 1033.4. Onsite facility requirements.

 A special event expected to involve the presence of more than 25,000 persons at any one time shall require the use of onsite treatment facilities. The onsite treatment facilities shall provide:

 (1) Environmental control, providing protection from weather elements to ensure patient safety and comfort.

 (2) Sufficient beds, cots and equipment to provide for evaluation and treatment of at least four simultaneous patients.

 (3) Adequate lighting and ventilation to allow for patient evaluation and treatment.

§ 1033.5. Communications system requirements.

 A special event EMS system shall have onsite communications capabilities to ensure:

 (1) Uniform access to care for patients in need of EMS.

 (2) Onsite coordination of the activities of EMS providers, including capability for interoperable communication with all EMS agencies involved in the plan and with EMS agencies local to the event site that are not involved in the special event EMS plan.

 (3) Communication with existing community PSAPs.

 (4) Communication interface with other involved public safety agencies.

 (5) Communication with receiving facilities.

 (6) Communication with ambulances providing emergency transportation.

 (7) Communication with medical command physicians.

§ 1033.6. Requirements for educating event attendees regarding access to EMS.

 (a) The entity responsible for the management and administration of a special event shall develop and implement a plan to educate special event participants and spectators about the following:

 (1) The presence and location of EMS at the special event.

 (2) The methods of obtaining EMS at the special event.

 (b) The entity responsible for the management and administration of a special event shall establish a procedure and means for alerting the participants and spectators of specific hazards or serious changing conditions, such as severe weather, and for providing event evacuation instructions.

§ 1033.7. Special event report.

 An entity for which the Department has approved a special event EMS plan shall complete a special event report form prepared by the Department and provided to it by the relevant regional EMS council and file the completed report with that regional EMS council within 30 days following the last day of a special event. Among other matters, the report shall provide a summary of the patient information required to be kept under § 1033.2(a)(1)(iv) (relating to administration, management and medical direction requirements).

[Pa.B. Doc. No. 11-1865. Filed for public inspection October 28, 2011, 9:00 a.m.]