STATE BOARD OF OSTEOPATHIC MEDICINE [49 PA. CODE CH. 25] Delegation of Medical Services [34 Pa.B. 58] The State Board of Osteopathic Medicine (Board) proposes to amend § 25.1 (relating to definitions) by adding a definition for ''emergency medical services personnel'' and to add § 25.217 (relating to delegation) to read as set forth in Annex A.
A. Effective Date
The proposed rulemaking will be effective upon publication as a final-form rulemaking in the Pennsylvania Bulletin.
B. Statutory Authority
Section 16 of the Osteopathic Medical Practice Act (act) (63 P. S. § 271.16) authorizes the Board to promulgate regulations necessary to carry out the purposes of the act. Section 3 of the act (63 P. S. § 271.3) permits osteopathic physicians to delegate medical services and acts to physician assistants, technicians or other allied medical personnel if services and acts are rendered under the supervision, direction or control of a licensed physician.
C. Background and Purpose
The Board routinely receives inquiries about whether a particular delegation of medical services is appropriate. In an effort to be responsive to the regulated community and to provide a framework that places patient safety and welfare at the forefront of the osteopathic physician's decision making process, the Board determined to codify basic criteria under which an osteopathic physician may delegate the performance of medical services to nonphysicians.
D. Description of Proposed Rulemaking
Section 3 of the act permits osteopathic physicians to delegate the performance of medical services. Section 3 of the act provides in relevant part as follows:
''Nothing in this act shall be construed to prohibit services and acts rendered by a qualified physician assistant, technician or other allied medical person if such services and acts are rendered under the supervision, direction or control of a licensed physician.''
The proposed rulemaking adds § 25.217. This section establishes general criteria under which an osteopathic physician may exercise professional judgment in making the decision to delegate medical services.
Section 25.217(a) establishes the criteria under which delegation could occur. Specifically, § 25.217(a)(1) requires that delegation be consistent with standards of acceptable medical practice. Standards of acceptable medical practice may be discerned from current medical literature and texts, medical teaching facilities publications and faculty, expert practitioners in the field and the commonly accepted practice of practitioners experienced in the field.
Section 25.217(a)(2) prohibits an osteopathic physician from expanding the scope of practice of other health care practitioners where the General Assembly or the licensing board responsible for regulating the other health care practitioner has prohibited the performance of those services by the other health care practitioner. Section 25.217(a)(3) requires the osteopathic physician to assure that the individual practitioner or technician to whom the delegation is being made has sufficient education, training and competency so that the delegatee knows how to perform the service safely. Accordingly, the osteopathic physician would be obligated to determine whether the delegatee is competent to perform the procedure. This may be accomplished by determining whether the delegatee is licensed, certified or possesses documented education and training related to the service. The physician may choose to monitor the delegatee to become satisfied as to the delegatee's competence.
Section 25.217(a)(4) prohibits delegation when the particular patient presents with unusual complications, family history or condition so that the performance of the medical service poses a special risk to that particular patient. Unlike the other provisions, this section directs the osteopathic physician's attention to the needs of the particular patient. A determination shall be made that the service may be rendered to the particular patient without undue risk. It is the physician's responsibility to make that assessment.
Section 25.217(a)(5) recognizes that patients are autonomous and that consideration of patient autonomy and dignity is a responsibility of the osteopathic physician. Thus, it is the osteopathic physician's responsibility to assure that the patient is advised as to the nature of the medical service and the reason for the delegation, so that the patient might exercise his right to request the service be performed by the osteopathic physician. The primary relationship in the delivery of medical services is between the patient and the physician. The person in charge of this relationship is the patient. Communication with the patient and education of the patient is essential to the proper delivery of medical services, and a primary obligation of physicians.
Section 25.217(a)(6) directs the osteopathic physician to provide the level of supervision and direction appropriate to the circumstance surrounding the delivery of the medical service. It underscores the fact that the osteopathic physician is ultimately responsible for the patient's well-being and requires the physician to maintain the level of involvement in the treatment process as required by section 3 of the act.
Section 25.217(b) prohibits the delegation of a medical service when the service is sufficiently complicated, difficult or dangerous that it would require a degree of education and training possessed by osteopathic physicians, but not commonly possessed by nonphysicians. Additionally, this section prohibits delegation of medical services in situations when potential adverse reactions may not be readily apparent to an individual without physician training. These criteria are intended to prohibit the delegation of medical services when the delegation poses undue risk to patients generally.
Section 25.217(c) requires the osteopathic physician to be sufficiently knowledgeable about the medical service so that the osteopathic physician is not merely a straw man. It should be axiomatic that the individual who has responsibility and authority for directing others in delivering medical services has the knowledge, ability and competency pertaining to the performance of those services.
Section 25.217(d) reminds osteopathic physicians that they retain responsibility for the performance of the service whether they perform it themselves or direct another to do so.
Section 25.217(e) recognizes the reality that emergencies arise when available health care personnel must immediately attend to patients, even though under nonemergency circumstances, the osteopathic physician would be the most appropriate person to care directly for the patient.
Section 25.217(f) recognizes that licensed or certified health care practitioners have a scope of practice defined by statute and regulations. This proposed rulemaking is not intended to restrict or limit the performance of medical services that fall within the parameters established by law. Specific examples have been provided because of concerns that were expressed to the Board pertaining to those practitioners. They are provided as examples and are not intended to be all-inclusive.
E. Fiscal Impact and Paperwork Requirements
There is no adverse fiscal impact or paperwork requirement imposed on the Commonwealth, political subdivisions or the private sector. Citizens of this Commonwealth will benefit in that this proposed rulemaking promotes patient safety and welfare as a consideration in making medical service delegation decisions.
F. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on December 16, 2003, the Board 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 Consumer Protection and Professional Licensure Committee and the House Professional Licensure Committee. 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 shall 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 Board, the General Assembly and the Governor of comments, recommendations or objections raised.
H. Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed rulemaking to Amy L. Nelson, Board Counsel, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of the proposed rulemaking in the Pennsylvania Bulletin. Cite ''delegation of medical services'' when submitting comments.
THOMAS R. CZARNECKI, D.O.,
ChairpersonFiscal Note: 16A-5312. No fiscal impact; (8) recommends adoption.
Annex A TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDSPART I. DEPARTMENT OF STATE Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRSCHAPTER 25. STATE BOARD OF
OSTEOPATHIC MEDICINESubchapter A. GENERAL PROVISIONS § 25.1 Definitions.
The following words and terms, when used in this chapter, have the following meanings unless the context clearly indicates otherwise:
* * * * * Emergency medical services personnel--Individuals who deliver emergency medical services and who are regulated by the Department of Health under the Emergency Medical Services Act (35 P. S. §§ 6921--6938).
* * * * * Subchapter D. MINIMUM STANDARDS OF PRACTICE § 25.217. Delegation.
(a) An osteopathic physician may delegate to a health care practitioner or technician the performance of a medical service if the following conditions are met:
(1) The delegation is consistent with the standards of acceptable medical practice embraced by the osteopathic physician community in this Commonwealth. Standards of acceptable medical practice may be discerned from current peer reviewed medical literature and texts, teaching facility practices and instruction, the practice of expert practitioners in the field and the commonly accepted practice of practitioners in the field.
(2) The delegation is not prohibited by the statutes or regulations relating to the other health care practitioner.
(3) The osteopathic physician has knowledge that the delegatee has education, training, experience and continued competency to safely perform the medical service being delegated.
(4) The osteopathic physician has determined that the delegation to a health care practitioner or technician does not create an undue risk to the particular patient being treated.
(5) The nature of the service and the delegation of the service has been explained to the patient and the patient does not object to the performance by the health care practitioner or technician. Unless otherwise required by law, the explanation may be oral and may be given by someone other than the osteopathic physician.
(6) The osteopathic physician assumes the responsibility for the delegated medical service, including the performance of the service, and is available to the delegatee as appropriate to the difficulty of the procedure, the skill of the delegatee and risk to the particular patient.
(b) An osteopathic physician may not delegate the performance of a medical service if performance of the medical service or if recognition of the complications or risks associated with the delegated medical service requires knowledge and skill not ordinarily possessed by nonphysicians.
(c) An osteopathic physician may not delegate a medical service which the osteopathic physician is not trained, qualified and competent to perform.
(d) An osteopathic physician shall be responsible for the medical services delegated to the health care practitioner or technician.
(e) An osteopathic physician may approve a standing protocol delegating medical acts to another health care practitioner who encounters a medical emergency that requires medical services for stabilization until the osteopathic physician or emergency medical services personnel are available to attend to the patient.
(f) This section does not prohibit a health care practitioner who is licensed or certified by a Commonwealth agency from practicing within the scope of that license or certificate or as otherwise authorized by law. For example, this section is not intended to restrict the practice of certified registered nurse anesthetists, nurse midwives, certified registered nurse practitioners, physician assistants or other individuals practicing under the authority of specific statutes or regulations.
[Pa.B. Doc. No. 04-17. Filed for public inspection January 2, 2004, 9:00 a.m.]
