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CHAPTER 107. MEDICAL STAFF
GENERAL PROVISIONS Sec.
107.1. Principle.
107.2. Medical staff membership.
107.3. Requirements for membership and privileges.
107.4. Medical staff status.
107.5. Membership appointment and reappointment.
MEDICAL STAFF BYLAWS, RULES AND REGULATIONS
107.11. Principle.
107.12. Content of bylaws, rules and regulations.
107.12a. Specified professional personnelstatement of policy.
ORGANIZATION OF THE MEDICAL STAFF
107.21. Principle.
107.22. Departments.
107.23. Clinical department chairmen.
107.24. Medical staff officers.
107.25. Medical staff executive committee.
107.26. Additional committees.
MEDICAL STAFF MEETINGS
107.31. Medical staff meetings.
107.32. Meetings and attendance.
107.33. Minutes.
MEDICAL STAFF EDUCATION PROGRAMS
107.41. Continuing education.
MEDICAL CARE REVIEW
107.51. Medical staff responsibilities.
107.52. Criteria.
107.53. Utilization review.
107.54. Medical audit.
MEDICAL ORDERS
107.61. Written orders.
107.62. Oral orders.
107.63. [Reserved].
107.64. Administration of drugs.
107.65. Automatic stop drug orders.Cross References This chapter cited in 28 Pa. Code § 101.4 (relating to definitions).
GENERAL PROVISIONS
§ 107.1. Principle.
There shall be an organized medical staff which is accountable to the governing body and which has responsibility for the quality of all medical care provided to patients and for the ethical conduct and professional practice of its members.
§ 107.2. Medical staff membership.
The medical staff shall be limited to physicians and dentists who have made application in accordance with the bylaws, rules, and regulations of the medical staff and with the bylaws of the hospital. Each member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The medical staff must define in bylaws the requirements for admission to staff membership and for the delineation and retention of clinical privileges. The governing body of the hospital, after considering the recommendations of the medical staff, may grant clinical privileges to other qualified, licensed practitioners in accordance with their training, experience, and demonstrated competence and judgment. Members of the medical staff and those granted clinical privileges shall currently hold licenses to practice in this Commonwealth.
§ 107.3. Requirements for membership and privileges.
(a) In order to receive favorable recommendation for appointment or reappointment, members of the medical staff must always act in a manner consistent with the highest ethical standards and levels of professional competence.
(b) Privileges granted shall be commensurate with an individuals qualifications, experience, and present capabilities.
(c) No applicant shall be denied medical staff privileges on the basis of sex, race, creed, color, or national origin or on the basis of any other criterion lacking professional or ethical justification, including association with a prepaid group practice.
§ 107.4. Medical staff status.
(a) Every hospital shall have an active medical staff to deliver the preponderance of medical services within the hospital. The active medical staff shall be responsible for its own organization and administration and should perform all significant duties pertaining thereto. Every member of the active medical staff shall be eligible to vote at staff meetings and to hold office.
(b) In addition to the active medical staff, the hospital may provide for additional kinds of medical staff privileges as delineated in subsection (c). The existence of additional staff categories shall in no way modify the privileges, duties, and responsibilities of the active medical staff.
(c) Additional staff categories may include the following:
(1) Associate medical staff. There may be an associate medical staff consisting of individuals who are being considered for advancement to the medical staff. Members of the associate medical staff shall be appointed and assigned to departments or services in the same manner as are members of the active medical staff. Although they may not hold office, they may serve on some medical staff hospital committees. The active medical staff should determine the extent of voting privileges to be granted to members of the associate medical staff.
(2) Courtesy medical staff. There may be a courtesy medical staff consisting of those medical practitioners eligible for staff membership who are given privileges to admit an occasional patient to the hospital. Courtesy staff members may neither vote nor hold office. Because admission of patients to the hospital is an exercise of a privilege and, therefore, is accompanied by a responsibility, admission of more than an occasional patient should require the practitioner to seek membership on the active medical staff.
(3) Temporary medical staff privileges. Temporary clinical privileges at the time of emergency or locum tenens may be granted to a medical practitioner for a limited and stated period on the recommendation of the chief of the applicable department/service or the president of the staff and with the concurrence of the chief executive officer.
(4) Consulting medical staff. There may be a consulting medical staff consisting of medical practitioners of recognized professional ability who are not members of another category of the medical staff and who have signified willingness to accept appointment to the consulting staff. Members of the consulting staff may neither vote nor hold office.
(5) Honorary medical staff. There may be an honorary medical staff consisting of former staff members, retired or emeritus, and of other practitioners of outstanding reputation whom the medical staff desires to honor. Those who are members of the honorary medical staff exclusively may neither vote nor hold office.
(d) Applicants approved for membership on the active, associate, or courtesy staff shall serve an initial provisional staff appointment. During this appointment, they must be assigned to departments services where their clinical competence and their ethical and moral conduct may be observed by a designated member of the active medical staff until such time as the probationary requirements established by the medical staff have been fulfilled.
§ 107.5. Membership appointment and reappointment.
(a) The governing body shall affirm or refuse the appointment of any physician or dentist to the medical staff or the granting of clinical privileges to any practitioner after considering the recommendation of the active medical staff in accordance with the procedure established pursuant to subsection (b).
(b) Formal application for membership and for granting of clinical privileges shall follow established procedures set forth in the bylaws, rules and regulations of the medical staff. These procedures shall provide the following:
(1) A written record of the application, which shall include the scope of privileges sought and granted.
(2) A review, summarized on record with appropriate documentation, of the qualifications of the applicant.
(3) A reasoned statement, in writing, by the medical staff recommending or declining to recommend the applicant.
(4) Written notice to the applicant of the recommendation of the medical staff, including notice of an applicants right to a hearing and reexamination before the medical staff or the governing body, or both.
(5) A review by a joint committee of the active medical staff and the governing body in cases where the governing body does not concur in the medical staffs recommendation regarding the granting or refusing of clinical privileges. Such review shall occur prior to the rendering of a final decision by the governing body.
(c) Reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.
(d) No appointment or reappointment to the medical staff shall be denied on the basis of sex, race, creed, color or National origin.
Authority The provisions of this § 107.5 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).
Source The provisions of this § 107.5 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52759).
MEDICAL STAFF BYLAWS, RULES AND REGULATIONS
§ 107.11. Principle.
The provisions of this § 107.12 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).
Source The provisions of this § 107.12 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52760) and (52762).
Notes of Decisions Determination of the appropriate method of judicial review of a hospitals revocation of a physicians staff privileges should be determined on basis of procedural safeguards and there is no distinction between public, private and quasi-public hospitals. Allison v. Centre Community Hospital, 604 A.2d 294 (Pa. Cmwlth. 1992).
Cross References This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnelstatement of policy); 28 Pa. Code § 107.61 (relating to written orders); and 28 Pa. Code § 117.43 (relating to medical records).
§ 107.12a. Specified professional personnelstatement 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 Departments 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) Section 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. § § 422.1422.45), section 10 of the Osteopathic Medical Practice Act and The Professional Nursing Law (63 P. S. § § 211225.5) and regulations promulgated thereunder in 49 Pa. Code Chapters 18, 21 and 25 (relating to State Board of Medicinepractitioners 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.
ORGANIZATION OF THE MEDICAL STAFF
§ 107.21. Principle.
The medical staff shall be organized to accomplish its required functions. It shall provide for the election or appointment of its officers. The complexity of the medical staff organization shall be commensurate with the size of the hospital and the scope of the activities of the medical staff.
Cross References This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).
§ 107.22. Departments.
Departmentalization should occur when the medical staff duties and functions become too complex to be handled by the staff as a whole.
Cross References This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).
§ 107.23. Clinical department chairperson.
Each clinical department chairperson in a departmentalized hospital shall be responsible for departmental implementation of actions taken by the medical staff. He must maintain continuing surveillance of the professional performance of all members of the medical staff with privileges in his department and must report regularly thereon to the medical staff. A clinical department chairman should be certified by the appropriate Board, be eligible for Board certification, or have successfully completed an approved residency training program in the clinical field of which he is chairman.
Cross References This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).
§ 107.24. Medical staff officers.
There shall be such officers of the medical staff organization as will provide effective control of its affairs and ensure proper discharge of the responsibility for the quality of medical care delegated to the medical staff by the governing body.
Cross References The provisions of this § 107.26 issued under 67 Pa.C.S. § § 61016104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).
Source The provisions of this § 107.26 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial pages (37801) and (37802).
Cross References This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations); and 28 Pa. Code § 115.34 (relating to medical records review).
MEDICAL STAFF MEETINGS
§ 107.31. Medical staff meetings.
There shall be regular medical staff and departmental meetings for the purpose of reviewing the performance of the medical staff, departments/services and reports and recommendations of medical staff and multi-disciplinary committees.
§ 107.32. Meetings and attendance.
Where the medical staff is departmentalized, the frequency of general staff meetings shall be determined by the medical staff and clearly stated in the medical staff bylaws and rules and regulations. Departmental meetings should be held monthly. When the medical staff is not departmentalized, medical staff meetings shall be conducted at least ten times annually, at monthly intervals. There shall be at least an annual meeting of the medical staff at which officers and committee chairmen make such reports as may be desirable and at which officers are elected for the ensuing year.
§ 107.33. Minutes.
Minutes shall be taken at each meeting and retained in accordance with the policy of the hospital. These minutes shall adequately reflect the transactions, conclusions and recommendations of the meetings.
Authority The provisions of this § 107.33 issued under 67 Pa.C.S. § § 61016104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).
Source The provisions of this § 107.33 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37803).
MEDICAL STAFF EDUCATION PROGRAMS
§ 107.41. Continuing education.
The medical staff shall require a continuing program of professional education for medical staff members, or require its members to give evidence of participation in such a program.
MEDICAL CARE REVIEW
§ 107.51. Medical staff responsibilities.
(a) In order for the medical staff to take reasonable steps to ensure clinical practice of the highest quality, each staff member should endeavor to:
(1) Provide his patients with the best quality of care consistent with the circumstances of each case.
(2) Conduct his professional activities in accordance with the bylaws, rules and regulations of the medical staff.
(3) Assist in the promotion and maintenance of high quality care through the analysis, review, and evaluation of the clinical practice which exists within the hospital.
(b) The medical staff shall have in effect a system to review medical services rendered, to assure their quality, and to provide an educational process for medical staff members. There shall be written procedures and policies governing the process and frequency of review.
§ 107.52. Criteria.
The provisions of this § 107.53 issued under 67 Pa.C.S. § § 61016104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).
Source The provisions of this § 107.53 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37804).
§ 107.54. Medical audit.
(a) Medical audit shall include periodic review, on a sample or other basis, of the care rendered to patients in every medical department of the hospital. The audit shall cover admission, length of stay and professional services furnished.
(b) The medical audit process should include both practitioners and allied health professionals from the hospital staff and should be interdisciplinary in nature.
(c) Minutes shall be taken at all medical audit committee meetings, and these minutes made available to the medical staff on a regular basis in accordance with established policy. These minutes shall be retained on file for no less than two years.
Authority The provisions of this § 107.54 issued under 67 Pa.C.S. § § 61016104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).
Source The provisions of this § 107.54 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37804).
MEDICAL ORDERS
§ 107.61. Written orders.
Medication or treatment shall be administered only upon written and signed orders of a practitioner acting within the scope of his license and qualified according to medical staff bylaws and § 107.12(k) (relating to content of bylaws, rules and regulations) except as provided in § § 107.62, 107.64 and 107.65 (relating to oral orders; administration of drugs; and automatic stop drug orders). The date that the order was written shall be included on all written orders.
Authority The provisions of this § 107.61 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).
Source The provisions of this § 107.61 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52769).
Cross References This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnelstatement of policy); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); and 28 Pa. Code § 115.33 (relating to entries).
§ 107.62. Oral orders.
(a) Oral orders for medication or treatment shall be accepted only under urgent circumstances when it is impractical for the orders to be given in written manner by the responsible practitioner. Oral orders shall be taken only by personnel qualified according to medical staff bylaws who shall transcribe the orders in the proper place in the medical record of the patient. The order shall include the date, time, and full signature of the person taking the order and shall be countersigned by a practitioner within 24 hours. If the practitioner is not the attending physician, he must be authorized by the attending physician and must be knowledgeable about the patients condition.
(b) The medical staff bylaws shall specify personnel who are qualified to accept oral orders and shall specify that acceptance of orders is limited to personnel listed in this subsection, with restrictions as noted:
(1) A practitioner.
(2) A professional nurse.
(3) A licensed practical nurse.
(4) A pharmacist who may transcribe oral orders pertaining to drugs.
(5) A physical therapist who may transcribe oral orders pertaining to physical therapy regimens.
(6) A respiratory therapist who may transcribe oral orders pertaining to respiratory therapy treatments.
(7) A paramedic practicing under § 117.30 (relating to emergency paramedic services).
Authority The provisions of this § 107.62 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).
Source March 27, 1985, 15 Pa.B. 250. Immediately preceding text appears at serial pages (77251) to (77252).
Cross References This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnelstatement of policy); 28 Pa. Code § 107.61 (relating to written orders); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); 28 Pa. Code § 113.23 (relating to records); 28 Pa. Code § 115.33 (relating to entries); and 28 Pa. Code § 117.41 (relating to emergency patient care).
§ 107.63. [Reserved].
Source The provisions of this § 107.63 reserved September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37806).
§ 107.64. Administration of drugs.
Drugs shall be administered only upon the proper order of a practitioner acting within the scope of his license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training. Graduate practical nurses, graduate nurses, and students in approved schools of nursing may be authorized to administer drugs, but only under the supervision of a registered professional nurse or a physician under 49 Pa. Code § 21.14 (relating to administration of drugs). A paramedic may be permitted to administer drugs only under § 117.30 (relating to emergency paramedic services) and Chapter 2, Subchapter A (relating to emergency medical technicians). Further policies on the administration of drugs shall be established by the medical staff in conjunction with the pharmacy committee.
Authority The provisions of this § 107.64 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).
Source The provisions of this § 107.64 amended January 25, 1985, effective March 27, 1985, 15 Pa.B. 250. Immediately preceding text appears at serial pages (77251) to (77252).
Cross References This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnelstatement of policy); 28 Pa. Code § 107.61 (relating to written orders); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); and 28 Pa. Code § 115.33 (relating to entries).
§ 107.65. Automatic stop drug orders.
The medical staff shall establish a written policy pursuant to § 113.26 (relating to administration of drugs) for all dangerous medications not specifically prescribed as to time or number of doses to be automatically stopped after a reasonable time limit. The prescriber shall be notified according to hospital policies and procedures within 48 hours before an order is automatically stopped.
Cross References This section cited in 28 Pa. Code § 107.61 (relating to written orders); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); 28 Pa. Code § 113.26 (relating to administration of drugs); and 28 Pa. Code § 115.33 (relating to entries).
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