PROPOSED RULEMAKING
STATE BOARD OF MEDICINE
[49 PA. CODE CH. 16]
Administration of Anesthesia
[26 Pa.B. 5009] The State Board of Medicine (Board) proposes to adopt § 16.98 (relating to administration of anesthesia) to read as set forth in Annex A. This proposed regulation establishes the standard of practice in regard to the supervision by medical doctors of the administration of anesthesia by certified registered nurse anesthetists.
This proposal was initiated by a ''Petition for the Issuance of Regulations Concerning the Delegation of Medical Services to Nurse Anesthetists'' (Petition) filed with the Board on May 17, 1993, by the Pennsylvania Medical Society and the Pennsylvania Society of Anesthesiologists (Societies). Subsequent to the receipt of the Societies' Petition, the Board invited comment from interested parties, including the State Board of Nursing and professional associations.
The Societies' Petition requested the Board develop regulations which would ''define the conditions under which a physician may delegate the performance of medical services to a certified registered nurse anesthetist.'' Specifically, the Petition sought regulations which would require the physical presence, direction and supervision of a physician with graduate training in anesthesia whenever a nurse anesthetist administered anesthesia.
In response to the Petition, the Board received comments in opposition to the development of restrictions to the use of nurse anesthetists from the State Board of Nursing, the Hospital Association of Pennsylvania (HAP), the Pennsylvania Association of Nurse Anesthetists (PANA), the Brookville Hospital and several individual nurse anesthetists. HAP's comments in opposition to the development of additional regulations in this area indicated that the ''combined Department of Health Regulations and licensure requirements, regulations of the State Boards of Medicine and Nursing, Joint Commission on Accreditation of Health Care Organizations (JCAHO) requirements, together with each licensed entity's bylaws, protocols, and quality and risk management initiatives, provide the necessary guidance for the safe delivery of anesthesia services in the Commonwealth.'' The Board does not intend, by this regulation, to restrict the use of nurse anesthetists, but rather provide for appropriate supervision when nurse anesthetists are utilized. When nurse anesthetists are utilized, the regulation provides minimum standards for the supervision of the procedure by the delegating physician who is ultimately responsible. The Board does not view these standards as inconsistent with those standards referenced by HAP.
PANA and the other commentators were concerned that the regulation would require supervision by a Board certified anesthesiologist. They contended that level of supervision was unnecessary. The Board agrees that supervision by a Board certified anesthesiologist is not necessary. However, the Board believes that a physician supervising the administration of anesthesia should possess knowledge sufficient to make the supervision meaningful.
After considering the evidence presented by the various interested parties, the Board determined that there appears to be a need for a uniform standard of practice regarding the delegation of the administration of anesthesia. Specifically, the Board is of the opinion that supervision of a nurse anesthetist by a physician who has graduate training in anesthesia is necessary to safeguard the health, safety and welfare of the citizens of this Commonwealth to whom anesthesia may be administered. The Board's conclusion is supported by the study published in Medical Care, July 1992, ''Hospital and Patient Characteristics Associated with Death After Surgery.'' That study suggested that incidence of death was less in hospitals in which the administration of anesthesia was overseen by qualified personnel.
Accordingly, the Board proposes to adopt § 16.98, which would provide for the supervision of the administration of anesthesia by a nurse anesthetist. The regulation would authorize the delegation to a nurse anesthetist of the administration of anesthetic agents to render a patient sedate, unconscious or insensible to pain provided that the supervising medical doctor has successfully completed an approved anesthesia graduate medical training program; the medical doctor specifies the anesthetic plan and signs the anesthetic record; the medical doctor is physically present in the treatment area (unless the medical doctor's presence is needed to address a medical emergency elsewhere in the facility); and the delegation (when occurring in a health care facility) is in keeping with written policies and procedures approved by the medical staff and governing body of the health care facility.
Finally, the Board makes clear in subsection (b) that the requirements of subsection (a) will not apply to the administration of conscious sedation. Conscious sedation is defined as that state in which the patient retains the ability to independently and continuously maintain an airway and remains responsive to stimuli.
Statutory Authority
This regulation is proposed under the authority of section 17(b) of the Medical Practice Act of 1985 (63 P. S. § 422.17(b)), which authorizes the Board to promulgate regulations which establish criteria under which a medical doctor may delegate the performance of medical services.
Fiscal Impact and Paperwork Requirements
The proposed regulation will have no fiscal impact on the Commonwealth or its political subdivisions. No new paperwork requirements are established.
Executive Order 1996-1
The Board's development of this regulation involved significant public comment during the drafting stage. Although the comments were received prior to the issuance of Executive Order 1996-1, the requirements of the Executive Order pertaining to the solicitation of public comment have been met.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), the Board submitted a copy of this proposed regulation on October 8, 1996, to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Committee on Professional Licensure and the Senate Committee on Consumer Protection and Professional Licensure. In addition to submitting the proposed regulation, the Board has provided IRRC and will provide the Committees with a detailed regulatory analysis form prepared by the Board in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has objections to any portion of the proposed regulation, it will notify the Board within 30 days of the close of the public comment period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for the Board, the Governor and the General Assembly to review these objections before final publication of the regulation.
Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed regulation to Cindy L. Warner, Board Administrator, State Board of Medicine, 116 Pine Street, Post Office Box 2649, Harrisburg, PA 17105-2649, within 30 days of publication of this proposed rulemaking.
CHARLES J. BANNON, M.D.,
ChairpersonFiscal Note: 16A-493. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRS
CHAPTER 16. STATE BOARD OF MEDICINE--GENERAL PROVISIONS
Subchapter F. MINIMUM STANDARDS OF PRACTICE § 16.98. Administration of anesthesia.
(a) A licensed medical doctor may delegate to a licensed registered nurse, who is a certified registered nurse anesthetist, the administration of anesthetic agents or adjunctive agents to render a patient sedate, unconscious or insensible to pain for a surgical, diagnostic or obstetric procedure, if the following conditions are met:
(1) The medical doctor has successfully completed an approved anesthesia graduate medical training program or is certified by his specialty board as appropriately trained and experienced in the properties and use of all anesthetic agents or adjunctive agents and the performance of anesthetic and patient monitoring procedures which are employed.
(2) The medical doctor specifies the anesthetic plan to the certified registered nurse anesthetist and signs the anesthetic record.
(3) The medical doctor is physically present in the treatment area during the administration of anesthesia. The medical doctor may be excused from the physical presence requirement to cover a medical emergency elsewhere in the facility.
(4) Delegation occurring within a health care facility licensed under the Health Care Facilities Act (35 P. S. §§ 448.101--448.901) shall be in accordance with written policies and procedures approved by the medical staff and governing body of the health care facility.
(b) Subsection (a) does not apply to the administration of ''conscious sedation,'' which is defined as a minimally depressed level of consciousness in which the patient retains the ability to independently and continuously maintain an airway and respond appropriately to physical stimulation and verbal commands.
[Pa.B. Doc. No. 96-1741. Filed for public inspection October 18, 1996, 9:00 a.m.]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
