RULES AND REGULATIONS
STATE BOARD OF OSTEOPATHIC MEDICINE
[49 PA. CODE CH. 25]
Delegation of Medical Services
[34 Pa.B. 6414] The State Board of Osteopathic Medicine (Board) amends § 25.1 (relating to definitions) by adding a definition for ''emergency medical services personnel'' and amends Subchapter D (relating to minimum standards of practice) by adding § 25.217 (relating to osteopathic physician delegation of medical services) to read as set forth in Annex A.
A. Effective Date
This will be effective upon publication as final-form rulemaking in the Pennsylvania Bulletin.
B. Statutory Authority
Section 16 of the Osteopathic Medical Practice Act (63 P. S. § 271.16) (act) 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 these 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. Summary of Comments and Responses on Final-Form Rulemaking
Notice of the proposed rulemaking was published at 34 Pa.B. 58 (January 3, 2004). The Board received comments from the Independent Regulatory Review Commission (IRRC) and the Pennsylvania Association of Nurse Anesthetists (PANA).
IRRC noted that § 25.217(a)(5) permits someone other than the osteopathic physician to explain the nature and delegation of the medical service to the patient. IRRC pointed out that this subsection is inconsistent with section 3 of the act which indicates that delegated services are to be ''rendered under the supervision, direction or control of a licensed physician.'' IRRC recommended that the regulations should specify the physician's role in the explanation given to the patient. The Board agreed with this recommendation and amended the language to require that the explanation be given by the physician or the physician's designee.
PANA expressed concern that the rulemaking would restrict the practice of other licensed health care practitioners. PANA also expressed concern that the regulation does not provide objective criteria to determine the knowledge or skill of the physician who may be delegating to an individual with more skill and expertise in that particular matter than the physician. The delegation may currently occur under the act. This final-form rulemaking will give further guidance to physicians in delegating medical services to both licensed health care practitioners as well as unlicensed technicians.
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 final-form 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 January 3, 2004, the Board submitted a copy of the notice of proposed rulemaking, published at 34 Pa.B. 58, to IRRC and the Chairpersons of the House Professional Licensure Committee (HPLC) and the Senate Consumer Protection and Professional Licensure Committee (SCP/PLC) for review and comment.
Under section 5(c) of the Regulatory Review Act, IRRC, the HPLC and the SCP/PLC 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 HPLC, the SCP/PLC and the public.
Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on October 19, 2004, the final-form rulemaking was approved by the HPLC. On November 3, 2004, the final-form rulemaking was deemed approved by the SCP/PLC. Under section 5.1(e) of the Regulatory Review Act, IRRC met on November 4, 2004, and approved the final-form rulemaking.
H. Contact Person
Interested persons may obtain information regarding the final-form rulemaking by writing to Beth Sender Michlovitz, Board Counsel, State Board of Osteopathic Medicine, P. O. Box 2649, Harrisburg, PA 17105-2649 or bmichlovit@state.pa.us.
I. 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 at 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) The final-form rulemaking is necessary and appropriate for administration and enforcement of the authorizing act.
(4) This final-form rulemaking is necessary and appropriate for administration and enforcement of the authorizing act and does not enlarge the purpose of the proposed rulemaking published at 34 Pa.B. 58.
J. Order
The Board, acting under its authorizing statutes, orders that:
(a) The regulations of the Board, 49 Pa. Code Chapter 25, are amended by amending § 25.1 and by adding § 25.217 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.
(b) The Board shall submit this order and Annex A to the Office of General Counsel and to 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 on publication in the Pennsylvania Bulletin.
THOMAS R. CZARNECKI, D.O.,
Chairperson(Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 34 Pa.B. 6292 (November 20, 2004).)
Fiscal Note: Fiscal Note 16A-5312 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 25. STATE BOARD OF
OSTEOPATHIC MEDICINE
Subchapter 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 the osteopathic physician or the osteopathic physician's designee.
(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. 04-2141. Filed for public inspection December 3, 2004, 9:00 a.m.]
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