[33 Pa.B. 4789]

The Department of Health (Department) adopts § 107.12a (relating to specified professional personnel--statement of policy) to read as set forth in Annex A. The statement of policy clarifies the hospital regulations that apply to the use of certified registered nurse practitioners (CRNPs), physician assistants (PAs) and certified nurse midwives (CNMs) to provide services in hospitals licensed by the Department.

The scope of practice for CRNPs, PAs and CNMs has expanded in recent years and hospitals seek to use services provided by CRNPs, PAs and CNMs to a greater extent. It is the Department's policy to facilitate the practice of licensed or certified health professionals that is appropriate to the practice setting. The proper use of these health professionals in the acute care setting can enhance the quality of care provided to patients.

The Department intends that § 107.12 (relating to content of bylaws, rules and regulations) will apply to and include CRNPs, PAs and CNMs. Section 107.12 permits specified professional personnel who are qualified to render direct medical care under the supervision of a member of the medical staff to exercise judgment within their areas of competence, directly participate in the management of patients and write orders.

This statement of policy notifies providers and the general public of the Department's interpretation of current regulatory standards. The statement of policy does not establish, repeal or amend current regulatory standards. The statement of policy clarifies that the Department expects hospitals that use CRNPs, PAs and CNMs to comply with § 107.12 and other pertinent requirements currently in statute or regulation that apply to CRNPs, PAs and CNMs providing services in hospital settings.

These include:

* State Board of Nursing regulations in 49 Pa. Code Chapter 21, Subchapter C (relating to certified registered nurse practitioners).

* State Board of Medicine regulations in 49 Pa. Code Chapter 18, Subchapters A and D (relating to licensure and regulation of midwife activities; and physician assistants).

* State Board of Osteopathic Medicine regulations in 49 Pa. Code Chapter 25, Subchapter C (relating to physician assistant provisions).

* Section 8.2 of The Professional Nursing Law (63 P. S. § 218.2).

* Section 13 and 35 of the Medical Practice Act of 1985 (63 P. S. §§ 422.13 and 422.35).

* Section 10 of the Osteopathic Medical Practice Act (63 P. S. § 271.10).
The Department intends in the future to modify its regulations and it is likely that standards regarding licensed or certified health professional personnel will be addressed at that time.

Department's Process for Enforcement

Hospitals in which CRNPs, PAs and CNMs are providing direct medical services that have not complied with the previous regulatory and statutory standards should insure compliance within 90 days of the publication of this statement of policy. At that time, the Department will begin to review hospital practices with respect to these standards. The Department will review bylaws, policies and procedures and written agreements to assure compliance with regulatory requirements and will expect the hospital to comply with the procedures set forth in its own medical staff bylaws, rules and regulations.

Comments

Although this statement of policy is effective upon publication, the Department will consider comments.

Contact Person

Comments and questions regarding this statement of policy should be directed to Sandra Knoble, Director, Division of Acute and Ambulatory Care, Room 532, Health and Welfare Building, Harrisburg, PA 17120, (717) 783-8980, sknoble@state.pa.us.

Effective Date

This statement of policy is effective upon publication.

CALVIN B. JOHNSON, M.D., M.P.H.,
Secretary

(Editor's Note: The regulations of the Department, 28 Pa. Code Chapter 107, are amended by adding a statement of policy in § 107.12a to read as set forth in Annex A.)

Fiscal Note: 10-175. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 28. HEALTH AND SAFETY

PART IV. HEALTH FACILITIES

Subpart B. GENERAL AND SPECIAL HOSPITALS

CHAPTER 107. MEDICAL STAFF

MEDICAL STAFF BYLAWS, RULES AND REGULATIONS

§ 107.12a. Specified professional personnel--statement of policy.

(a) Scope. This section applies to hospitals that use ''specified professional personnel'' to provide direct medical care in accordance with § 107.12(14) (relating to content of bylaws, rules and regulations).

(b) Purpose. This section clarifies the Department's regulations as they affect the use of certified registered nurse practitioners (CRNPs), physician assistants (PAs) and certified nurse midwives (CNMs) in hospitals.

(c) Current regulations.

(1) Current hospital in § 107.12(14) permits ''specified professional personnel,'' including persons qualified to render direct medical care under the supervision of a member of the medical staff, to perform certain functions, including direct participation in the management of patients under the supervision or direction of a member of the medical staff and the writing of orders within the limits established by the medical staff.

(2) Sections 107.61, 107.62 and 107.64 (relating to written orders; oral orders; and administration of drugs) and other sections of the hospital regulations limit the performance of certain functions including the writing or countersigning of orders to practitioners, defined as licensed physicians, dentists or podiatrists. This definition appears to render § 107.12(14) ineffective.

(3) Commonwealth statutes and regulations defining CRNP, PA and CNM scope of practice permit those personnel to issue written and oral medical orders, take oral orders and otherwise render medical care and manage patients consistent with § 107.12(14).

(d) Policy regarding specified professional personnel. The Department will permit CRNPs, PAs and CNMs to function in hospitals as ''specified professional personnel'' under § 107.12, notwithstanding apparently conflicting provisions elsewhere in the regulations, in accordance with the following policy:

(1) The medical staff bylaws shall set forth the rules and regulations, qualifications, status, clinical duties and responsibilities of specified professional personnel, including CRNPs, PAs and CNMs. (§ 107.12(14)). When appropriate, the medical staff bylaws may incorporate by reference applicable rules and regulations, policies and procedures or hospital bylaws related to the foregoing. The medical staff bylaws, directly or by reference, shall also delineate the clinical privileges and duties of those specified professional personnel as well as the responsibilities of the physician members of the medical staff in relation to those specified professional personnel. (§ 107.12(5)). Finally, the bylaws, directly or by reference, shall specify who is authorized to evaluate the significance of medical histories, to authenticate medical histories, to perform and record physical examinations and to provide treatment. (§ 107.12(11)).

(2) Upon incorporation of the provisions in paragraph (1) as they pertain to CRNPs, PAs and CNMs into the medical staff bylaws, CRNPs, PAs and CNMs are permitted to perform the following functions in accordance with § 107.12:

(i) Exercise of judgment within their area of competence provided that a physician member of the medical staff has the ultimate responsibility for patient care.

(A) Some scope of practice rules mandate the development of an agreement in writing between the physician and the CRNP, PA or CNM that must address certain aspects of the relationship appropriate to the practice setting.

(B) Some agreements must be filed with the applicable State board, and some must be approved by the applicable State Board. (See 49 Pa. Code Chapter 18, Subchapters A and D (relating to licensure and regulation of midwife activities; and physician assistants); 49 Pa. Code Chapter 21, Subchapter C (relating to certified registered nurse practitioners); 49 Pa. Code Chapter 25, Subchapter C (relating to physician assistant provisions); section 8.2 of The Professional Nursing Law (63 P. S. § 218.2); sections 13 and 35 of the Medical Practice Act of 1985 (63 P. S. §§ 422.13 and 422.35); and section 10 of the Osteopathic Medical Practice Act (63 P. S. § 271.10)).

(C) The agreement must contain the provisions required by regulation or statute, and satisfactorily address physician availability appropriate to the provision of quality care in an acute care facility.

(D) In the case of multiple supervising physicians, one agreement may be used as long as each physician is named in and signs the agreement and other applicable requirements of the State boards are met.

(E) The facility must maintain a copy of each written agreement, with evidence of filing with the applicable State board, if the filing is required by the Board, and approval, if the approval is required by the Board, for verification by the Department of compliance with regulations and statutes governing scope of practice.

(ii) Direct participation in the management of patients under the supervision or direction of a licensed physician who is a member of the medical staff. Scope of practice rules require that the physician with whom the CRNP, PA or CNM has an agreement shall be onsite or readily available for consultation by telephone, radio, or telecommunications. Under certain circumstances described in the rules, a physician shall be physically present to direct the PA.

(iii) Writing of orders and recording of reports and progress notes in medical records of patients, within the limits established by the medical staff. Scope of practice limitations are contained in the Medical Practice Act of 1985 (63 P. S. §§ 422.1--422.45), section 10 of the Osteopathic Medical Practice Act and The Professional Nursing Law (63 P. S. §§ 211--225.5) and regulations promulgated thereunder in 49 Pa. Code Chapters 18, 21 and 25 (relating to state board of medicine--practitioners other than medical doctors; state board of nursing; and state board of osteopathic medicine).

(3) As required by 49 Pa. Code § 21.291 (relating to institutional health care facility committee; committee determination of standard policies and procedures), the hospital shall establish a committee in each area of practice whose function is to establish standard policies and procedures, in writing, pertaining to the scope and circumstances of practice of CRNPs in the medical management of the patient. Under this section, the committee serves as an advisory and interpretive body to the various staff of the hospital, and includes equal representation from the medical staff, the nursing staff and nursing administration.

[Pa.B. Doc. No. 03-1895. Filed for public inspection September 26, 2003, 9:00 a.m.]

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