Section 551.3. Definitions

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

ASF—Ambulatory surgical facility—

(i) A facility or portion thereof not located upon the premises of a hospital which provides specialty or multispecialty outpatient surgical treatment.

(ii) This does not include individual or group practice offices of private physicians or dentists, unless the offices have a distinct part used solely for outpatient surgical treatment on a regular and organized basis. For the purposes of this provision, outpatient surgical treatment means treatment to patients who do not require hospitalization, but who require constant medical supervision following the surgical procedure performed.

Act—The Health Care Facilities Act (35 P. S. § § 448.101—448.904).

Ambulatory surgery—Surgery which is performed:

(i) On an outpatient basis in a facility which is not located in a hospital.

(ii) On patients who do not require hospitalization but who do require constant medical supervision following the surgical procedure performed and whose total length of stay does not exceed the standards in this subpart.

Anesthesia—The use of pharmaceutical agents to induce the loss of sensation. For the purpose of this chapter, the term applies when any patient, in any setting receives, for any purpose, by any route, one of the following:

(i) General, spinal or other regional anesthesia.

(ii) Sedation (with or without analgesia), for which there is a reasonable expectation that, in the manner used, will result in the loss of protective reflexes for a significant percentage of a group of patients.

Anesthesiologist—A physician licensed by the State Board of Medicine under the Medical Practice Act of 1985 (63 P. S. § § 422.1—422.45) who has completed an accredited residency training program in anesthesia.

Anesthetist—A generic term used to identify anesthesiologists, nurse anesthetists or dentist anesthetists.

Authenticate—To verify authorship for example by written signature, identifiable initials or computer key.

Authorized person to administer drugs and medications—In an ASF, the term includes the following:

(i) Persons who are currently licensed or certified by the Bureau of Professional and Occupational Affairs, Department of State, and whose scope of practice includes the administration of drugs.

(ii) Registered nurses who are currently licensed by the Bureau of Professional and Occupational Affairs, Department of State.

(iii) Practical nurses who have successfully passed the State Board of Nursing examination.

(iv) Practical nurses licensed by waiver in this Commonwealth who have successfully passed the United States Public Health Service Proficiency Examination.

(v) Practical nurses licensed by waiver in this Commonwealth who have successfully passed a medication course approved by the State Board of Nursing.

(vi) Student nurses of approved nursing programs who are functioning under the direct supervision of a member of the school faculty who is present in the facility.

(vii) Recent graduates of approved nursing programs who are functioning under the direct supervision of a professional nurse who is present in the facility and who possesses valid temporary practice permits. The permits shall expire if the holders of the permits fail the licensing examinations.

(viii) Physician assistants and registered nurse practitioners who are certified by the Bureau of Professional and Occupational Affairs.

Board certified—A physician licensed to practice medicine or osteopathic medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant specialty or subspecialty area, or both, recognized by one of the following groups:

(i) The American Board of Medical Specialties.

(ii) The American Osteopathic Association.

(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii).

Classification levels—ASFs shall be classified as follows:

(i) Class A—A private or group practice office of practitioners where procedures performed are limited to those requiring administration of either local or topical anesthesia, or no anesthesia at all and during which reflexes are not obtunded.

(ii) Class B—A single-specialty or multiple-specialty facility with a distinct part used solely for ambulatory surgical treatments involving administration of sedation analgesia or dissociative drugs wherein reflexes may be obtunded; and where patients are limited to Physical Status (PS) PS-I or PS-II patients, unless the patient’s PS status would not be adversely affected or sought to be remedied by the surgery. A Class B ASF may be a distinct part of a private or group practice medical or dental office so long as the requirements of this subpart are met.

(iii) Class C—A single-specialty or multiple-specialty facility used exclusively for the purpose of providing ambulatory surgical treatments which involve the use of a spectrum of anesthetic agents, up to and including general anesthesia and where patients are limited to physical status (PS) PS-1, PS-2 or PS-3 patients.

Classification system—A process used to identify three levels of ASFs (A, B and C) based on the procedure, patient status and anesthesia used.

Clinical privileges—Permission to independently render medical care in the ASF which is granted by the governing body under § 553.4(c) and (d) (relating to other functions).

Compliance directive—A directive issued by the Department, citing deficiencies which have come to the attention of the Department through the survey process, or by onsite inspection and directing the ASF to take corrective action as the Department directs or to submit a plan of correction.

Deficiency—A condition which exists contrary to, in violation of, or in noncompliance with this subpart.

Dentist—A person licensed by the State Board of Dentistry under The Dental Law (63 P. S. § § 120—130b).

Dentist anesthetist—A person licensed by the State Board of Dentistry who has met the requirements for providing anesthesia care services in accordance with the regulations of that Board.

Department—The Department of Health of the Commonwealth.

Distinct part—An area which is part of a practitioner’s office which is physically identifiable and where surgery is performed on a regular and organized basis.

Drug administration—An act in which a single dose of an identified drug is given to a patient.

Drug dispensing—The issuance of one or more doses of a prescribed medication under § § 25.41—25.101.

Facilities—Buildings, equipment and supplies necessary for implementation of ASF services.

Governing body—The individuals, group or entity that has ultimate authority and responsibility for establishing policy, maintaining quality patient care and providing for organizational management and planning.

Graduate nurse—A graduate of an approved program of professional nursing practicing the profession under The Professional Nursing Law (63 P. S. § § 221—225).

Licensed practical nurse—A person licensed to practice practical nursing under The Practical Nurse Law (63 P. S. § § 651—667).

Medical—Pertaining to the practice of medicine, osteopathy, podiatry or dentistry.

Medical staff—The organized group of practitioners who has been appointed by the governing body of the ASF to function under § § 555.1—555.3 (relating to principle; medical staff membership; and requirements for membership and privileges).

NFPA—The National Fire Protection Association.

New construction—New buildings, additions to existing buildings, conversion of existing buildings or portions thereof or portions of buildings undergoing alterations other than repair.

Nurse anesthetist—A registered nurse licensed by the State Board of Nursing providing anesthesia care in accordance with the requirements of the regulations of that Board.

Nurse practitioner—A person who has been certified by the State Board of Nursing and the State Board of Medicine to perform acts of medical diagnosis or prescription of medical, therapeutic or corrective measure in collaboration with and under the direction of a physician licensed to practice medicine in this Commonwealth, under the Medical Practice Act of 1985 and The Professional Nursing Law.

Nursing services—Patient care aspects of nursing that are performed by registered nurses or by licensed practical nurses and ancillary nursing personnel under the direct supervision of a registered nurse.

Organized—Administratively and functionally structured to include the following:

(i) Governing body.

(ii) Medical staff.

(iii) Quality assurance.

(iv) Nursing services.

(v) Pharmacy services.

(vi) Medical record services.

(vii) Laboratory and radiology services.

(viii) Environmental services.

(ix) Fire and safety services.

Outpatient surgical treatment—Surgical procedures performed upon patients who do not require hospitalization but who require constant medical supervision following the surgical procedure performed.

Person in charge—The individual appointed by the governing body to act in its behalf in the overall management of the ASF.

Pharmacist—A person licensed to engage in the practice of pharmacy in this Commonwealth under The Pharmacy Act (63 P. S. § § 390.1—390.13).

Pharmacy—A place where the practice of pharmacy is conducted under The Pharmacy Act.

Physical status classifications—The evaluation of the patient’s overall health as it would influence the conduct and outcome of anesthesia or surgery, or both. Physical status shall be defined within one of five assigned classes which are:

(i) Class 1 patients have no organic, physiologic, biochemical, metabolic or psychiatric disturbance. The operation to be performed is for a local pathologic process and has no systemic effect.

(ii) Class 2 patients have a systemic disturbance which may be of a mild to moderate degree but which is either controlled or has not changed in its severity for some time.

(iii) Class 3 patients suffer from significant systemic disturbance, although the degree to which it limits the patient’s functioning or causes disability may not be quantifiable.

(iv) Class 4 patients suffer from severe systemic diseases that are already life-threatening and may or may not be correctable by surgery.

(v) Class 5 patients are moribund and not expected to survive without surgery.

Physician—A doctor of medicine or osteopathy who holds a current and valid license to practice in this Commonwealth.

Physician assistant—A person who has been certified by the State Board of Medicine or the State Board of Osteopathic Medical Examiners to assist a physician or group of physicians under The Medical Practice Act of 1985 or The Osteopathic Medical Practice Act (63 P. S. § § 271.1—271.18).

Podiatrist—A person licensed by the State Board of Podiatry Examiners to practice podiatry under The Podiatry Act of 1956 (63 P. S. § § 42.1—42.21a).

Practitioner—A licensed physician, dentist or podiatrist.

Preboard certification status—A physician licensed to practice medicine or osteopathic medicine in this Commonwealth who has completed the requirements necessary to take a certification examination offered by a specialty board recognized by the American Board of Medical Specialties, the American Osteopathic Association or the foreign equivalent of either group, and who has been eligible to take the examination for no longer than 3 years.

Premises of a hospital—Buildings, equipment and supplies licensed as a hospital to provide inpatient and outpatient services.

Professional nurse/registered nurse—A person licensed to practice professional nursing under The Professional Nursing Law.

Provider—An individual; a trust or estate; a partnership; a corporation including associations, joint stock companies, health maintenance organizations, professional health service plan corporations and insurance companies; the Commonwealth or a political subdivision or instrumentality thereof, including a municipal corporation or authority that operates an ambulatory surgical facility; and any other legal entity that operates an ambulatory surgical facility.

Secretary—The Secretary of the Department.

Surgery—The branch of medicine that diagnoses and treats diseases, disorders, malformations and injuries wholly or partially by operative procedures.

Survey—The process of evaluation or reevaluation of the compliance of an ASF with this subpart.

The provisions of this § 551.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (251634) to (251637).

Notation

Cross References

This section cited in 28 Pa. Code § 555.32 (relating to administration of anesthesia).