PROPOSED RULEMAKING
STATE BOARD OF MEDICINE
[49 PA. CODE CH. 18]
Physician Delegation of Medical Services
[31 Pa.B. 5113] The State Board of Medicine (Board) proposes to adopt Chapter 18, Subchapter G (relating to medical doctor delegation of medical services) to read as set forth in Annex A.
A. Effective Date
The regulation will be effective upon publication as a final-form regulation in the Pennsylvania Bulletin.
B. Statutory Authority
Section 17(b) of the Medical Practice Act of 1985 (act) (63 P. S. § 422.17(b)) authorizes the Board to promulgate criteria under which a medical doctor may delegate the performance of medical services, preclude a medical doctor from delegating the performance of certain types of medical services or otherwise limit the ability of a medical doctor to delegate medical services.
C. Background and Purpose
The Board routinely receives inquiries about whether particular delegations are appropriate. To assist medical doctors in exercising professional judgment regarding delegation, the Board published in its summer 1997 newsletter an article which provided an analytical framework for making delegation decisions. The concepts discussed in that article were well received by the medical doctor community. However, the Board continued to receive numerous requests for regulatory guidelines pertaining to delegation. In an effort to be responsive to the regulated community, and to provide a framework that placed patient safety and welfare at the forefront of the medical doctor's decision making process, the Board determined to codify basic criteria under which a medical doctor may delegate the performance of medical services.
D. Description of the Amendment
Section 17 of the act (63 P. S. § 422.17) authorizes medical doctors to delegate the performance of medical services. Section 17 of the act provides as follows:
(a) General rule. A medical doctor may delegate to a health care practitioner or technician the performance of a medical service if:
(1) The delegation is consistent with the standards of acceptable medical practice embraced by the medical doctor community in this Commonwealth.
(2) The delegation is not prohibited by regulations promulgated by the Board.
(3) The delegation is not prohibited by statutes or regulations relating to other licensed health care practitioners.
(b) Regulations. The Board may promulgate regulations which establish criteria under which a medical doctor may delegate the performance of medical services, preclude a medical doctor from delegating the performance of certain types of medical services or otherwise limit the ability of a medical doctor to delegate medical services.
(c) Responsibility. A medical doctor shall be responsible for the medical services delegated to the health care practitioner or technician in accordance with subsections (a) and (b). A medical doctor's responsibility for the medical service delegated to the health care practitioner or technician is not limited by any provisions of this section.
Against this statutory backdrop, the Board proposes this rulemaking.
The proposal would add § 18.401 (relating to delegation). This section would establish general criteria under which a medical doctor may exercise professional judgment in making the decision to delegate medical services.
Section 18.401(a) would establish criteria under which delegation could occur:
Section 18.401(a)(1) would reiterate the statutory requirement found in section 17(a)(1) of the act that the 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 18.401(a)(2) would reiterate section 17(a)(3) of the act. This section would prohibit a medical doctor from expanding the scope of practice of other health care practitioners when 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 18.401(a)(3) and (4) would require the medical doctor to assure that the individual practitioner or technician to whom the delegation is being given has sufficient education, training and competency so that they know how to perform the service safely. Accordingly, the medical doctor 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 18.401(a)(5) would prohibit delegations 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 provision directs the medical doctor'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 18.401(a)(6) would recognize that patients are autonomous and that consideration of patient autonomy and dignity is a responsibility of the medical doctor. Thus, it is the medical doctor'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 the right to request the service be performed by the medical doctor. 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 18.401(a)(7) would direct the medical doctor 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 medical doctor is ultimately responsible for the patient's well being and requires the doctor to maintain the level of involvement in the treatment process as required by section 21 of the act (63 P. S. § 422.21).
Section 18.401(b) would prohibit the delegation of a medical service when the service is sufficiently complicated, difficult or dangerous so that it would require a degree of education and training possessed by medical doctors, but not commonly possessed by nonmedical doctors. Additionally, this section would prohibit delegation of medical services in situations when potential adverse reactions may not be readily apparent to an individual without medical doctor training. These criteria are intended to prohibit the delegation of medical services when the delegation poses undue risk to patients generally.
Section 18.401(c) would require the medical doctor to be sufficiently knowledgeable about the medical service so that the medical doctor 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 18.401(d) would reiterate the statutory requirement contained in section 17(c) of the act. It reminds the medical doctor that the medical director retains responsibility for the performance of the service whether the doctor performs it or directs another to do so.
Section 18.401(e) would recognize the reality that emergencies arise when available health care personnel must immediately attend to patients, even though under nonemergency circumstances, the medical doctor would be the most appropriate person to care directly for the patient.
Section 18.401(f) would recognize that licensed or certified health care practitioners have a scope of practice defined by statute and regulations. This proposed regulation 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. Compliance with Executive Order 1996-1
In accordance with Executive Order 1996-1 (February 6, 1996), in drafting and promulgating the regulation, the Board solicited input and suggestions from the regulated community and other parties who have identified themselves as interested in the Board's regulatory agenda.
F. 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 regulation promotes patient safety and welfare as a consideration in making medical service delegation decisions.
G. Sunset Date
The Board continuously monitors its regulations. Therefore, no sunset date has been assigned.
H. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 24, 2001, the Board submitted a copy of this proposed regulation to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Professional Licensure Committee and the Senate Consumer Protection and Professional Licensure Committee. In addition to submitting the regulation, the Board has provided IRRC and the Committees with a copy of a detailed regulatory analysis form prepared by the Board in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of the material is available to the public upon request.
If IRRC has any objections to any portion of the proposed regulation, it will notify the Board within 10 days after the expiration of the Committees' review 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 review, prior to final publication of the regulation, by the Board, the General Assembly and the Governor of objections raised.
I. Public Comment
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed regulation to Cindy Warner, Health Licensing Division, Bureau of Professional and Occupational Affairs, P. O. Box 2649, Harrisburg, PA 17105-2649 within 30 days following publication of the proposed regulation in the Pennsylvania Bulletin. Please cite to ''delegation of medical services'' when submitting comments.
CHARLES D. HUMMER, Jr.,
ChairpersonFiscal Note: 16A-4912. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 49. PROFESSIONAL AND VOCATIONAL STANDARDS
CHAPTER 18. STATE BOARD OF MEDICINE--PRACTITIONERS OTHER THAN MEDICAL DOCTORS
Subchapter G. MEDICAL DOCTOR DELEGATION OF MEDICAL SERVICES Sec.
18.401. Delegation. § 18.401. Delegation.
(a) A medical doctor 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 medical doctor community in this Commonwealth.
(2) The delegation is not prohibited by the statutes or regulations regulating the other health care practitioner.
(3) The delegatee has documented education and training to perform the medical service being delegated.
(4) The medical doctor has determined that the delegatee is competent to perform the medical service.
(5) The medical doctor has determined that the delegation to a health care practitioner or technician does not create an undue risk to that patient.
(6) 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.
(7) The medical doctor assumes the responsibility for evaluating and monitoring the performance of the service and is available as appropriate to the difficulty of the procedure, the skill of the delegatee and risk level to the particular patient.
(b) A medical doctor may not delegate the performance of a medical service if performance of the medical service requires medical doctor education and training or if recognition of the complications or risks associated with the delegated medical service requires medical doctor education and training.
(c) A medical doctor may not delegate a medical service which the medical doctor is not trained, qualified and competent to perform.
(d) A medical doctor shall be responsible for the medical services delegated to the health care practitioner or technician.
(e) A medical doctor may approve a standing protocol delegating medical acts to another health care provider who encounters a medical emergency that requires medical services for stabilization until the medical doctor is able to attend to the patient.
(f) This section does not prohibit a health care provider 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, certified registered nurse practitioners, physician assistants, or other individuals practicing under the authority of specific statutes or regulations.
[Pa.B. Doc. No. 01-1645. Filed for public inspection September 7, 2001, 9:00 a.m.]
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