RULES AND REGULATIONS
[49 PA. CODE CH. 18]
Physician Delegation of Medical Services
[34 Pa.B. 43] The State Board of Medicine (Board) adds §§ 18.401 and 18.402 (relating to definitions; and delegation) to read as set forth in Annex A.
A. Effective Date
The final-form rulemaking is effective upon publication 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 Amendments
Section 17 of the act 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 pursuant to 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.Section 18.402 establishes general criteria under which a medical doctor may exercise professional judgment in making the decision to delegate medical services. In response to comments received, the Board added § 18.401. This section adds the statutory definition of ''emergency medical services personnel,'' which is referenced in § 18.402(e).
Section 18.402(a) establishes criteria under which delegation could occur.
Section 18.402(a)(1) reiterates the statutory requirement found in section 17(a)(1) of the act that the delegation be consistent with standards of acceptable medical practice. The final-form rulemaking identifies examples of sources of standards of acceptable medical practice such as 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 18.402(a)(2) reiterates section 17(a)(3) of the act. This section prohibits 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 18.402(a)(3) requires the medical doctor to assure that the individual practitioner or technician to whom the delegation is being given has sufficient education, training, experience and competency so that they know how to perform the service safely. Accordingly, the medical doctor is 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)(4) as proposed was deleted; the requirement that the physician determine that the delegatee is competent to perform the delegated task was incor- porated into § 18.402(a)(3). Renumbered § 18.402(a)(4) (proposed paragraph (5)) prohibits 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 must 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 18.402(a)(5) (proposed § 18.401(a)(6)) recognizes 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 18.402(a)(6) (proposed § 18.401(a)(7)) directs 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 18.402(b) prohibits the delegation of a medical service when the service is sufficiently complicated, difficult or dangerous so that it would require a degree of knowledge and skill possessed by medical doctors, but not commonly possessed by nonphysicians. Additionally, this subsection prohibits 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 18.402(c) requires 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 18.402(d) reiterates the statutory requirement contained at section 17(c) of the act. It reminds medical doctors that they retain responsibility for the performance of the service whether they perform it themselves or direct another to do so.
Section 18.402(e) recognizes 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 18.402(f) recognizes that licensed or certified health care practitioners have scope of practice defined by statute and regulations. This final-form 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. Public Comment.
The Board entertained public comment for a period of 30 days during which time the Board received 11 comments from individuals and organizations. Following the close of the public comment period, the Board received comments from the Independent Regulatory Review Commission (IRRC) and the House Professional Licensure Committee (HPLC). The following is a summary of the comments and the Board's response.
IRRC submitted several comments and suggestions. IRRC expressed concern that the rulemaking merely restated the statutory delegation provisions and did not provide guidance beyond those. The Board disagrees with that assessment. The rulemaking provides a framework for practitioners to determine if delegation is appropriate. IRRC also suggested that the Board define the terms ''medical service,'' ''health care practitioner'' and ''technician.'' Because those terms are defined in the act, the Board declined to restate the definitions in the final-form rulemaking. IRRC also recommended that the Board clarify in subsection (a)(1) what constitutes standards of acceptable medical practice. The law firm of Kalogredis, Sansweet, Dearden and Burke also recommended that an explanation of that term be added to subsection (a)(1). The Board agreed that an explanation would be helpful, and therefore it amended the final-form rulemaking to include the explanation set forth in the preamble.
IRRC also expressed concern that subsection (a)(4) of the proposed rulemaking did not indicate how a doctor was to determine that a delegatee was competent to perform the delegated service. The Board agreed, and amended the final-form rulemaking by deleting subsection (a)(4) and amending (a)(3) to require the doctor to have actual knowledge that the delegatee has the necessary education, training, experience and competency to safely perform the delegated task. The Board declined IRRC's suggestion that proposed subsection (a)(5) (now subsection (a)(4)) be amended to require the doctor to document in the patient's chart that the delegation does not present an undue risk to the patient. Many of the delegated tasks are routine medical procedures such as taking blood pressure or giving a shot. It would be burdensome to require that each delegated task be separately documented. The Board did amend proposed subsection (a)(6) (now subsection (a)(5)) to further clarify the manner in which the nature of the service and delegation are explained to the patient. IRRC also recommended amending proposed subsection (a)(7) (now subsection (a)(6)) to clarify that the physician must retain responsibility for the delegated service. The Board agreed with this suggested and amended the final-form rulemaking.
The Board also accepted IRRC's recommendation that it replace the language ''medical doctor education and training'' in section (b) with the phrase ''knowledge and skill not ordinarily possessed by nonphysicians.'' The Board also accepted IRRC's suggestion that it use the term ''health care practitioner'' rather than ''health care provider'' in subsections (e) and (f).
The HPLC questioned why delegation is necessary if a nonphysician health care provider is licensed or certified to perform the delegated service. Section 17 of the act specifically permits a doctor to delegate the performance of a medical service to a health care practitioner. A health care practitioner is defined in section 2 of the act (63 P. S. § 422.2) as an individual, other than a physician assistant, who is authorized to practice some component of the healing arts by a license, permit, certificate or registration issued by a Commonwealth licensing agency or board. A medical service is defined in section 2 of the act as an activity which lies within the scope of the practice of medicine and surgery. In the Board's view the legislation signifies an intent that delegation of a medical service to a licensed or certified individual is appropriate, and that the individual's license or certificate does not authorize the individual to perform medical services absent delegated authority from the physician.
The HPLC shared IRRC's concerns about the manner in which the nature of the service and delegation are explained to the patient in proposed subsection (a)(6) (now subsection (a)(5)). The Board added language to further clarify that subsection. The Board also amended proposed subsection (a)(7) (now subsection (a)(6)) to include the language suggested by the HPLC.
The HPLC asked ''what kind of medical services do not require medical education and training as opposed to those that do require medical education and training.'' 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 services requires medical doctor education and training knowledge and skill not ordinarily possessed by nonphysicians. That subsection was included to prohibit a physician from delegating those medical services which are so complicated, difficult or dangerous that they would normally require a degree of education and training possessed by physicians, but not normally possessed by nonphysicians. Subsection (f) was added in response to concerns expressed by groups representing various nonphysician licensed or certified health care practitioners that the proposed rulemaking may prohibit these licensees from performing medical services that fall within the parameters established by their licensing acts.
The Pennsylvania Medical Society (PMS) wrote in favor of the rulemaking, but suggested that proposed subsection (a)(5) (now subsection (a)(4)) be amended to indicate that the individual explaining the nature and delegation of the service be the physician or the physician's designee so that only the physician or a direct agent of the physician is responsible for this task. The Board agreed that this change clarified the lines of responsibility. The PMS also suggested that subsection (c) be amended to read that the physician must be trained, qualified and currently competent to perform the delegated service. The Board determined that adding the word ''currently'' would be superfluous, since a doctor who was not currently competent would not be considered qualified to perform the delegated service.
The Pennsylvania Academy of Family Physicians (PAFP) and the Pennsylvania College of Internal Medi-cine wrote to request clarification of proposed subsection (a)(6) (now subsection (a)(5)) regarding the manner in which the explanation of the medical service and delegation is given, as well as who will have responsibility for giving the explanation. The Board amended that language accordingly. The PAFP also requested clarification of the terms ''education and training'' in subsection (b). As previously noted, the Board replaced this language with the phrase ''knowledge and skill not ordinarily possessed by nonphysicians.'' The PAFP also objected to the language ''trained and qualified and competent'' in subsection (c), claiming that it was too vague. The Board disagrees and believes that this subsection is consistent with existing § 16.61(a)(3) (relating to unprofessional and immoral conduct) and provides sufficient guidance to physicians that they may not delegate medical services which they do not have sufficient knowledge, ability and competency to perform themselves.
The Hospital and Healthsystem Association of Pennsylvania, the Pennsylvania Association of Nurse Anesthetists, the Pennsylvania State Nurses Association and the Pennsylvania Higher Education Nursing Schools Association all expressed concern that the proposed rulemaking would restrict the practice of other licensed health care practitioners. The Hospital and Healthsystem Association of Pennsylvania also expressed concern that this rulemaking could enable doctors to delegate things to unlicensed individuals that should be done by other licensed health care practitioners. Under the act, this delegation may currently occur. The final-form rulemaking will give further guidance to physicians in delegating medical services to both licensed health care practitioners as well as unlicensed technicians. A private attorney, Louis J. Dell'Aquila, wrote to oppose the rulemaking claiming that it would create an additional basis for negligence or malpractice litigation. Obviously, there are some individuals and attorneys who will use the final-form rulemaking and any others published by the Board for their own gain. However, the Board believes that the final-form rulemaking will be helpful and will provide guidance to most physicians. Subsection (f) specifically states that the final-form rulemaking does not prohibit or restrict other licensed or certified health care practitioners from practicing within the scope of their license or certification. The Insurance Federation of Pennsylvania asked the Board to delay implementation of the regulation until the Pennsylvania Supreme Court decided Kleinberg v. SEPTA. The Board has long been of the opinion that these regulations do not favor either party's position in Kleinberg. Moreover, that case was decided by the Supreme Court on November 13, 2002.
The Pennsylvania Society of Anesthesiologists wrote in support of the final-form rulemaking.
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 final-form rulemaking 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 the notice of proposed rulemaking, published at 31 Pa.B. 5113 (September 8, 2001), to IRRC and the Chairpersons of the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) and the HPLC for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the SCP/PLC and the HPLC were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Board has considered all comments from IRRC, the House and Senate Committees and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on November 17, 2003, the final-form rulemaking was approved by the HPLC and deemed approved by SCP/PLC on November 19, 2003. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 20, 2003, and approved the final-form rulemaking.
I. Contact Person
Further information may be obtained by contacting Gerald S. Smith, Counsel, State Board of Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649, gerasmith@state.pa.us.
J. Findings
The Board finds that:
(1) Public notice of proposed rulemaking was given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations promulgated thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) This final-form rulemaking does not enlarge the purpose of proposed rulemaking published at 31 Pa.B. 5113.
(4) This final-form rulemaking is necessary and appropriate for administering and enforcing the authorizing acts identified in Part B of this preamble.
K. Order
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 18, are amended by adding §§ 18.401 and 18.402 to read as set forth in Annex A.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General as required by law.
(c) The Board shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(d) This order shall take effect upon publication in the Pennsylvania Bulletin.
CHARLES D. HUMMER, Jr. M.D.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 33 Pa.B. 5994 (December 6, 2003).)
Fiscal Note: Fiscal Note 16A-4912 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 49. PROFESSIONAL AND
VOCATIONAL STANDARDS
PART I. DEPARTMENT OF STATE
Subpart A. PROFESSIONAL AND
OCCUPATIONAL AFFAIRS
CHAPTER 18. STATE BOARD OF
MEDICINE--PRACTITIONERS OTHER
THAN MEDICAL DOCTORS
Subchapter G. MEDICAL DOCTOR
DELEGATION OF MEDICAL SERVICESSec.
18.401. Definitions. 18.402. Delegation. § 18.401. Definitions.
The following words and terms, when used in this subchapter, 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).
§ 18.402. 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. 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 other health care practitioners.
(3) The medical doctor has knowledge that the delegatee has education, training, experience and continued competency to safely perform the medical service being delegated.
(4) The medical doctor 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 the physician or the physician's designee.
(6) The medical doctor 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 level to the particular patient.
(b) A medical doctor 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) 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 is 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 practitioner who encounters a medical emergency that requires medical services for stabilization until the medical doctor 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. 04-12. Filed for public inspection January 2, 2004, 9:00 a.m.]
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