The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

   ACNM—The American College of Nurse-Midwives.

   Collaborating physician—A medical or osteopathic medical doctor who has hospital privileges in obstetrics, gynecology or pediatrics and who has entered into a collaborative agreement with a midwife.

   Collaborative agreement—A signed written agreement between a midwife and a collaborating physician in which they agree to the details of the collaborative arrangement between them with respect to the care of midwifery clients.

   Midwife—A person licensed by the Board to practice midwifery.

   Midwife examination—An examination offered or recognized by the Board to test whether an individual has accumulated sufficient academic knowledge with respect to the practice of midwifery to qualify for a midwife license. The Board recognizes the certifying examination of the ACNM as a midwife examination.

   Midwifery practice—anagement of the care of essentially normal women and their normal neonates—initial 28-day period. This includes antepartum, intrapartum, postpartum and nonsurgically related gynecological care.

   Midwife program—An academic and clinical program of study in midwifery which has been approved by the Board or by an accrediting body recognized by the Board. The Board recognizes the ACNM as an accrediting body of programs of study in midwifery.

   Midwife protocol—A written document developed by the midwife setting forth, in detail, the scope and limitations of the midwife’s intended practice.

   The provisions of this §  18.1 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

   The provisions of this §  18.1 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; amended May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161. Immediately preceding text appears at serial page (119272).

 The Board will grant a midwife license to an applicant who meets the following requirements. The applicant shall:

   (1)  Be licensed as a registered nurse in this Commonwealth.

   (2)  Satisfy the licensure requirements in §  16.12 (relating to general qualifications for licenses and certificates).

   (3)  Have successfully completed a midwife progam.

   (4)  Have obtained one of the following:

     (i)   A passing grade on a midwife examination. The Board accepts the passing grade on the certifying examination of the ACNM as determined by the ACNM.

     (ii)   ACNM certification as a midwife before the ACNM certification examination was first administered in 1971.

   (5)  Submit an application for a midwife license accompanied by the required fee. For the fee amount, see §  16.13 (relating to licensure, certification, examination and registration fees).

   The provisions of this §  18.2 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

 (a)  A midwife license shall be registered biennially. The procedure for the biennial registration of a midwife license is in §  16.15 (relating to biennial registration; inactive status and unregistered status).

 (b)  The fee for the biennial registration of a midwife license is set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

   The provisions of this §  18.3 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

 At a minimum, the midwife protocol shall identify the following:

   (1)  The procedures and routines of care, including specific treatment regimens to be provided by the midwife, by practice area—for example, antepartum, intrapartum, postpartum and nonsurgically related gynecological care.

   (2)  The circumstances under which consultation, co-management, referral and transfer of care of women and newborns are to take place, and the mechanics by which each are to occur.

   (3)  Procedures and routines of care of newborns, including specific treatment regimens, if the midwife manages the care of newborns beyond the time of delivery.

   The provisions of this §  18.4 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

 (a)  A midwife may not engage in midwifery practice without having entered into a collaborative agreement.

 (b)  A midwife shall only engage in midwifery practice in accordance with a midwife protocol and collaborative agreements.

 (c)  A collaborative agreement shall contain either an acknowledgment that the midwife shall practice under the midwife protocol, or that the midwife shall practice under the midwife protocol as expanded or modified in the collaborative agreement.

 (d)  Expansions and modifications of the midwife protocol agreed to by the midwife and the collaborating physician shall be set forth, in detail, in the collaborative agreement.

 (e)  If the collaborating physician intends to authorize the midwife to relay to other health care providers medical regimens prescribed by that physician, including drug regimens, that authority, as well as the prescribed regimens, shall be set forth in the collaborative agreement.

   The provisions of this §  18.5 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

 The midwife is authorized and required to do the following:

   (1)  Engage in midwifery practice as defined in §  18.1 (relating to definitions), as further provided for in this subchapter and in accordance with the ethical and quality standards of the profession as required in section 41(8) of the act (63 P. S. §  422.41(8)).

   (2)  Maintain a midwife protocol and collaborative agreements, and make them available for inspection by clients and the Board upon request.

   (3)  Prescribe medical, therapeutic and diagnostic measures for essentially normal women and their normal neonates in accordance with the midwife protocol or a collaborative agreement, or both.

   (4)  Administer specified drugs as provided in collaborative agreements or as directed by a collaborating physician for a specific patient and, if specifically authorized to do so in a collaborative agreement, relay to other health care providers medical regimens prescribed by the collaborating physician, including drug regimens.

   (5)  Perform medical services in the care of women and newborns that may be beyond the scope of midwifery, if the authority to perform those services is delegated by the collaborating physician in the collaborative agreement, the delegation is consistent with standards of practice embraced by the midwife and the relevant physician communities in this Commonwealth, and the delegated medical services do not involve the prescribing or dispensing of drugs.

   (6)  Refer and transfer to the care of a physician, as provided for in the midwife protocol or a collaborative agreement, or both, those women and newborns whose medical problems are outside the scope of midwifery practice and who require medical services which have not been delegated to the midwife in a collaborative agreement.

   (7)  Review and revise the midwife protocol and collaborative agreements as needed.

   (8)  Carry out responsibilities placed by law or regulation upon a person performing the functions that are performed by the midwife.

   The provisions of this §  18.6 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

 (a)  The Board may refuse, revoke, suspend, limit or attach conditions to the license of a midwife for engaging in conduct prohibited by section 41 of the act (63 P. S. §  422.41(8)) for Board-regulated practitioners.

 (b)  The Board will order the emergency suspension of the license of a midwife who presents an immediate and clear danger to the public health and safety, as required by section 40 of the act (63 P. S. §  422.40).

 (c)  The license of a midwife shall automatically be suspended, as required by section 40 of the act.

   The provisions of this §  18.7 amended under section 2 of the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. §  172); and sections 8 and 35(a) of the Medical Practice Act of 1985 (63 P. S. § §  422.8 and 422.35(a)).

   The provisions of this §  18.8 adopted January 2, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 24; reserved May 19, 1989, effective May 20, 1989, 19 Pa.B. 2161. Immediately preceding text appears at serial page (114029).

Subchapter B. REGISTRATION AND PRACTICE OF ACUPUNCTURISTS

Sec.

§ 18.11. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

   Acupuncture—

     (i)   The stimulation of certain points on or near the surface of the body by the insertion of needles to prevent or alleviate the perception of pain or to normalize physiological functions, including pain control, for the treatment of certain diseases or dysfunctions of the body.

     (ii)   The term also includes the use of supplemental techniques.

   Acupuncture educational program—Training and instruction in acupuncture or supplemental acupuncture techniques offered by a degree-granting institution authorized by the Department of Education that leads to a master’s degree, master’s level certificate or diploma or first professional degree, that meets the relevant and appropriate requirements of 22 Pa. Code (relating to education) and 24 Pa.C.S. Chapter 65 (relating to private colleges, universities and seminaries) and that meets or exceeds the standards required for acupuncture or Oriental medicine programs established by an accrediting agency recognized by the United States Department of Education.

   Acupuncture examination—An examination offered or recognized by the Board to test whether an individual has accumulated sufficient academic knowledge with respect to the practice of acupuncture and herbal therapy to qualify for the privilege of practicing as an acupuncturist or as a practitioner of Oriental medicine. The Board recognizes the NCCAOM component examinations in acupuncture and sterilization procedures as the examination for registration as an acupuncturist and the NCCAOM examination component in Chinese herbology as the examination for registration as a practitioner of Oriental medicine.

   Acupuncture medical program—An academic or clinical program of study in acupuncture which has been given category I continuing medical education credit by an institution accredited or recognized by the Accreditation Council on Continuing Medical Education to conduct category I continuing medical education courses.

   Acupuncturist—An individual registered to practice acupuncture by the Board.

   Chinese herbology—The study of the use of herbs in the Oriental medicine tradition.

   Herbal therapy—The application of Chinese herbology to the treatment of acupuncture patients.

   NCCAOM—The National Certification Commission for Acupuncture and Oriental Medicine.

   Practitioner of Oriental medicine—An acupuncturist who is registered by the Board to use herbal therapy.

   Supplemental techniques—The use of traditional and modern Oriental therapeutics, heat therapy, moxibustion, electrical and low level laser stimulation, acupressure and other forms of massage, herbal therapy and counseling that includes the therapeutic use of foods and supplements and lifestyle modifications.

   The provisions of this §  18.11 amended under section 3 of the Acupuncture Registration Act (63 P. S. §  1803); and section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8).

 A medical doctor who intends to practice acupuncture and any other individual who intends to practice acupuncture shall register with the Board as an acupuncturist.

   The provisions of this §  18.12 amended under section 3 of the Acupuncture Registration Act (63 P. S. §  1803).

 (a)  The Board will register as an acupuncturist a person who satisfies the following requirements:

   (1)  Has successfully completed an acupuncture educational program which includes a course in needle sterilization techniques.

   (2)  Has obtained a passing grade on an acupuncture examination or has been certified by NCCAOM. If the examination was not taken in English, but is otherwise acceptable and a passing score was secured, the Board will accept the examination result if the applicant has also secured a score of 550 on the test of English as a Foreign Language (TOEFL).

 (b)  The Board will register as an acupuncturist a medical doctor who satisfies the following requirements:

   (1)  Has successfully completed 200 hours of training in acupuncture medical programs including examinations required by those programs.

   (2)  Submits an application to register as an acupuncturist accompanied by the required fee. For the fee amount, see §  16.13 (relating to licensure, certification, examination and registration fees).

 (c)  Prior to January 1, 1988, the Board will register as an acupuncturist a medical doctor who satisfies the requirements of subsection (a), (b) or the following:

   (1)  Has at least 3 years of acupuncture practice—a minimum of 500 patient visits per year—documented to the satisfaction of the Board.

   (2)  Submits an application to register as an acupuncturist accompanied by the required fee. For the fee amount, see §  16.13.

   The provisions of this §  18.13 amended under section 3 of the Acupuncture Registration Act (63 P. S. §  1803); and section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8).

 (a)  An acupuncturist who also intends to use herbal therapy is required to be registered with the Board as a practitioner of Oriental medicine.

 (b)  The Board will register an acupuncturist as a practitioner of Oriental medicine if the registrant, in addition to meeting the requirements under §  18.13 (relating to requirements for registration as an acupuncturist) has fulfilled one of the following:

   (1)  Successfully completed an acupuncture education program that includes the study of Chinese herbology and has passed the NCCAOM examination component on Chinese herbology.

   (2)  Has obtained NCCAOM certification in Chinese herbology or Oriental medicine, which includes passing the NCCAOM examination component in Chinese herbology.

 (c)  An acupuncturist registered with the Board prior to April 14, 2007, may obtain a registration as a practitioner of Oriental medicine if the acupuncturist can demonstrate one of the following:

   (1)  Successful completion of a Chinese herbology or Oriental medicine education program recognized by the licensing authority of another state or United States territory for the practice of herbal therapy or Oriental medicine and successful completion of an examination in Chinese herbology or Oriental medicine recognized by the licensing authority of another state or United States territory for the practice of herbal therapy or Oriental medicine.

   (2)  NCCAOM certification in Chinese herbology or Oriental medicine.

   (3)  The achievement of cumulative qualifications that the Board determines to be equivalent to the standard requirements for registration as a practitioner of Oriental medicine.

 (d)  This subsection does not apply to a medical doctor registered as an acupuncturist nor does it restrict the practice of medicine by a medical doctor.

   The provisions of this §  18.13a issued under section 3 of the Acupuncture Registration Act (63 P. S. §  1803).

 (a)  Acupuncturists and practitioners of Oriental medicine shall register biennially and submit the appropriate registration fee to engage in the practice of acupuncture for the biennial period.

 (b)  Procedures for biennial registration of acupuncturists and practitioners of Oriental medicine are outlined in §  16.15 (relating to biennial registration; inactive status and unregistered status).

 (c)  The biennial registration fee is set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

   The provisions of this §  18.14 amended under section 3 of the Acupuncture Registration Act (63 P. S. §  1803).

 (a)  Responsibilities to patient. In relation to the acupuncture patient, the acupuncturist shall comply with the following:

   (1)  Received, in writing, from the acupuncturist supervisor, approval to initiate acupuncture treatment.

   (2)  Comply strictly with conditions or restrictions that may be placed on the course of acupuncture treatment by the acupuncturist supervisor.

   (3)  Not diagnose a physical or mental ailment or condition or prescribe or dispense a drug.

   (4)  Comply strictly with sterilization standards relative to aseptic practices.

 (b)  Responsibility to acupuncturist supervisor. In relation to the acupuncturist supervisor, the acupuncturist shall comply with the following:

   (1)  Consult promptly with the acupuncturist supervisor regarding a new ailment or condition or a worsened ailment or condition of an acupuncture patient.

   (2)  Consult with the acupuncturist supervisor upon request of either the acupuncturist supervisor or the acupuncture patient.

   (3)  Practice acupuncture only under the general supervision of an acupuncturist supervisor.

 (c)  Scope of acupuncturist’s responsibility.

   (1)  An acupuncturist is responsible solely for acupuncture evaluation and acupuncture treatment. The medical diagnosis is the responsibility of the acupuncturist supervisor.

   (2)  An acupuncturist is not required to practice acupuncture in the physical presence of the acupuncturist supervisor or at the location where the acupuncturist supervisor provides medical services. Where the acupuncturist may provide acupuncture services, and whether the acupuncturist may provide acupuncture services without the acupuncture supervisor being physically present, shall be determined by the acupuncture supervisor.

 (a)  An acupuncturist may practice acupuncture and use supplemental techniques but may not use herbal therapy.

 (b)  A practitioner of Oriental medicine may practice acupuncture and use supplemental techniques including herbal therapy.

 (c)  This subsection does not limit the scope of practice of a medical doctor who is registered as an acupuncturist.

   The provisions of this §  18.15a issued under section 3 of the Acupuncture Registration Act (63 P. S. §  1803).

 (a)  The Board may refuse, revoke, suspend, limit or attach conditions to the registration of an acupuncturist or practitioner of Oriental medicine for engaging in conduct prohibited by section 41 of the act (63 P. S. §  422.41) for Board-regulated practitioners.

 (b)  The Board will order the emergency suspension of the registration of an acupuncturist or practitioner of Oriental medicine who presents an immediate and clear danger to the public health and safety, as required by section 40 of the act (63 P. S. §  422.40).

 (c)  The registration of an acupuncturist or practitioner of Oriental medicine shall automatically be suspended, as required by section 40 of the act.

   The provisions of this §  18.18 amended under section 3 of the Acupuncture Registration Act (63 P. S. §  1803); and section 8 of the Medical Practice Act of 1985 (63 P. S. §  422.8).

   The provisions of this §  18.19 corrected January 9, 1987, effective immediately and applies retroactively to December 31, 1986, 17 Pa.B. 185; reserved April 13, 2007, effective April 14, 2007, 37 Pa.B. 1644. Immediately preceding text appears at serial page (222910).

Subchapter C. CERTIFIED REGISTERED NURSE PRACTITIONERS

GENERAL PROVISIONS

Sec.

§ 18.21. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

   Boards—The State Board of Nursing of the Commonwealth and the Board.

   Certified Registered Nurse Practitioner (C.R.N.P.)—A registered nurse licensed in this Commonwealth who is certified by the Boards in a particular clinical specialty area and who, while functioning in the expanded role as a professional nurse, performs acts of medical diagnosis or prescription of medical therapeutic or corrective measures in collaboration with and under the direction of a physician licensed to practice medicine in this Commonwealth. Nothing in this subchapter limits or prohibits a nurse from engaging in activities which normally constitute the practice of nursing as defined in section 2 of The Professional Nursing Law (63 P. S. §  212).

   Direction—The incorporation of physician supervision to the certified registered nurse practitioner’s performance of medical acts in the following ways:

     (i)   Immediate availability of a licensed physician through direct communications or by radio, telephone or telecommunications.

     (ii)   A predetermined plan for emergency services which has been jointly developed by the supervising physician and the certified registered nurse practitioner.

     (iii)   A physician available on a regularly scheduled basis for:

       (A)   Referrals.

       (B)   Review of the standards of medical practice incorporating consultation and chart review.

       (C)   Establishing and updating standing orders and drug and other medical protocols within the practice setting.

       (D)   Periodic up-dating in medical diagnosis and therapeutics.

 The Boards have established regulations to govern acts of medical diagnosis or prescription of medical therapeutic or corrective measures, as authorized by The Professional Nursing Law (63 P. S. § §  211—225.5) and the act.

LEGAL RECOGNITION

§ 18.31. Designation of C.R.N.P.; authority to use C.R.N.P.

 (a)  A registered nurse who has satisfactorily met the requirements set forth in this subchapter and regulations that may from time to time be jointly promulgated by the Boards shall be designated on his license ‘‘Certified Registered Nurse Practitioner (C.R.N.P.)’’, in the area for which qualified.

 (b)  No nurse may practice or offer to practice as a Certified Registered Nurse Practitioner in this Commonwealth or use the abbreviation C.R.N.P. unless authorized to do so by the State Board of Nursing.

REQUIREMENTS FOR APPROVAL

§ 18.41. Currently licensed; course of study and experience; continuing education.

 (a)  The applicant for whom approval is requested shall be currently licensed as a registered nurse by the State Board of Nursing.

 (b)  The applicant shall have successfully completed a course of study consisting of at least 1 academic year in a program administered by nursing in an institution of higher education as approved by the Boards.

 (a)  A registered nurse who has been granted certification by another state board may be granted certification in this Commonwealth by endorsement of the original certifying board if the credentials are equivalent to those required by the Boards.

 (b)  The applicant for certification in this Commonwealth by endorsement shall meet the requirements as stated in The Professional Nursing Law (63 P. S. § §  211—225.5) for licensure as a registered nurse.

APPLICATION FOR APPROVAL

§ 18.51. Application for approval.

 The applicant shall submit an application form, provided by the State Board of Nursing, to the State Board of Nursing for its review and approval. The application shall include the following:

   (1)  An official document from the program.

 Applicants approved by the State Board of Nursing may use the designation C.R.N.P. The designation and area of specialty will be indicated on the current license of the nurse.

CRNP PRACTICE

§ 18.53. Prescribing and dispensing drugs.

 A CRNP may prescribe and dispense drugs if the following requirements are met:

   (1)  The CRNP has completed a CRNP program which is approved by the Boards or, if completed in another state, is equivalent to programs approved by the Boards.

   (2)  The CRNP has successfully completed at least 45 hours of course work specific to advanced pharmacology in accordance with the following:

     (i)   The course work in advanced pharmacology may be either part of the CRNP education program or, if completed outside of the CRNP education program, an additional course or courses taken from an educational program or programs approved by the Boards.

     (ii)   The course work in advanced pharmacology must be at an advanced level above a pharmacology course required by a professional nursing (RN) education program.

   (3)  A CRNP who has prescriptive authority shall complete at least 16 hours of State Board of Nursing approved continuing education in pharmacology in the 2 years prior to the biennial renewal date of his or her CRNP certification. The CRNP shall show proof that she completed the continuing education when submitting a biennial renewal.

   (4)  In prescribing and dispensing drugs, a CRNP shall comply with standards of the State Board of Medicine in § §  16.92—16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and the Department of Health in 28 Pa. Code § §  25.51—25.58, 25.61—25.81 and 25.91—25.95.

   The provisions of this §  18.53 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)).

 (a)  The Board adopts the American Hospital Formulary Service Pharmacologic-Therapeutic Classification to identify drugs which the CRNP may prescribe and dispense subject to the parameters identified in this section.

 (b)  A CRNP may prescribe and dispense a drug relevant to the area of practice of the CRNP from the following categories if that authorization is documented in the collaborative agreement (unless the drug is limited or excluded under this or another subsection):

   (1)  Antihistamines.

   (2)  Anti-infective agents.

   (3)  Antineoplastic agents, unclassified therapeutic agents, devices and pharmaceutical aids if originally prescribed by the collaborating physician and approved by the collaborating physician for ongoing therapy.

   (4)  Autonomic drugs.

   (5)  Blood formation, coagulation and anticoagulation drugs, and thrombolytic and antithrombolytic agents.

   (6)  Cardiovascular drugs.

   (7)  Central nervous system agents, except that the following drugs are excluded from this category:

     (i)   General anesthetics.

     (ii)   Monoamine oxidase inhibitors.

   (8)  Contraceptives including foams and devices.

   (9)  Diagnostic agents.

   (10)  Disinfectants for agents used on objects other than skin.

   (11)  Electrolytic, caloric and water balance.

   (12)  Enzymes.

   (13)  Antitussive, expectorants and mucolytic agents.

   (14)  Gastrointestinal drugs.

   (15)  Local anesthetics.

   (16)  Eye, ear, nose and throat preparations.

   (17)  Serums, toxoids and vaccines.

   (18)  Skin and mucous membrane agents.

   (19)  Smooth muscle relaxants.

   (20)  Vitamins.

   (21)  Hormones and synthetic substitutes.

 (c)  A CRNP may not prescribe or dispense a drug from the following categories:

   (1)  Gold compounds.

   (2)  Heavy metal antagonists.

   (3)  Radioactive agents.

   (4)  Oxytocics

 (d)  If a collaborating physician determines that the CRNP is prescribing or dispensing a drug inappropriately, the collaborating physician shall immediately take corrective action on behalf of the patient and notify the patient of the reason for the action and advise the CRNP as soon as possible. This action shall be noted by the CRNP or the collaborating physician, or both, in the patient’s medical record.

 (e)  Restrictions on CRNP prescribing and dispensing practices are as follows:

   (1)  A CRNP may write a prescription for a Schedule II controlled substance for up to a 72 hour dose. The CRNP shall notify the collaborating physician as soon as possible but in no event longer than 24 hours.

   (2)  A CRNP may prescribe a Schedule III or IV controlled substance for up to 30 days. The prescription is not subject to refills unless the collaborating physician authorizes refills for that prescription.

 (f)  A CRNP may not:

   (1)  Prescribe or dispense a Schedule I controlled substance as defined in section 4 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §  780-14).

   (2)  Prescribe or dispense a drug for a use not approved by the United States Food and Drug Administration without approval of the collaborating physician.

   (3)  Delegate prescriptive authority specifically assigned to the CRNP by the collaborating physician to another health care provider.

 (g)  A prescription blank shall bear the certification number of the CRNP, name of the CRNP in printed format at the top of the blank and a space for the entry of the DEA registration number, if appropriate. The collaborating physician shall also be identified as required in §  16.91 (relating to identifying information on prescriptions and orders for equipment and service).

 (h)  The CRNP shall document in the patient’s medical record the name, amount and dose of the drug prescribed, the number of refills, the date of the prescription and the CRNP’s name.

   The provisions of this §  18.54 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)).

   The provisions of this §  18.54 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943.

 (a)  A collaborative agreement is the signed written agreement between a CRNP and a collaborating physician in which they agree to the details of the collaborative arrangement between them with respect to the care of CRNP patients.

 (b)  The collaborative agreement between a physician and a CRNP who will prescribe drugs shall satisfy the following requirements. The agreement shall:

   (1)  Identify the parties, including the collaborating physician, the CRNP and a substitute physician who will provide collaboration and direction for up to 30 days if the collaborating physician is unavailable.

   (2)  Identify the area of practice in which the CRNP is certified.

   (3)  Identify the categories of drugs from which the CRNP may prescribe or dispense in accordance with §  18.54 (relating to prescribing and dispensing parameters).

   (4)  Contain attestation by the collaborating physician that the physician has knowledge and experience with any drug that the CRNP will prescribe.

   (5)  Specify the circumstances and how often the collaborating physician will personally see the patient, based on the type of practice, sites of service and condition of the patient, whether the treatment is for an ongoing or new condition, and whether the patient is new or continuing.

   (6)  Specify the conditions under which the CRNP may prescribe a Schedule II controlled substance for up to 72 hours.

   (7)  Be kept at the primary practice location of the CRNP and a copy filed with the Bureau of Professional and Occupational Affairs.

   (8)  Be made available for inspection to anyone seeking to confirm the scope of practice of the CRNP.

   (9)  Be updated by the collaborating physician and the CRNP whenever it is changed substantively.

   (10)  Specify the amount of professional liability insurance carried by the CRNP.

 (c)  The CRNP shall notify the Bureau whenever a collaborative agreement of a CRNP who prescribes and dispenses drugs is updated or terminated.

   The provisions of this §  18.55 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)).

 (a)  A patient shall be informed at the time of making an appointment that the patient will be seen by a CRNP.

 (b)  A CRNP shall wear a name tag that clearly identifies the CRNP with the title ‘‘Certified Registered Nurse Practitioner.’’

 (c)  A CRNP who holds a doctorate should take appropriate steps to inform patients that the CRNP is not a doctor of medicine or doctor of osteopathic medicine.

   The provisions of this §  18.56 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)).

 (a)  At any time a physician may not supervise more than four CRNPs who prescribe and dispense drugs. This subsection does not limit the number of collaborative agreements that a physician may have with prescribing CRNPs. By way of example, a physician may supervise four prescribing CRNPs who work in the morning and four other prescribing CRNPs who work in the afternoon as long as the physician has a collaborative agreement with each CRNP.

 (b)  A physician may apply for a waiver of the supervision requirements expressed in subsection (a) for good cause, as determined by the Boards.

 (c)  The limit of the general rule of not more than four prescribing CRNPs to one physician does not apply to CRNPs who do not prescribe or dispense drugs. By way of example, a physician may supervise at the same time four CRNPs who prescribe and dispense drugs and one or more CRNPs who do not prescribe and dispense drugs.

   The provisions of this §  18.57 issued under section 15(b) of the Medical Practice Act of 1985 (63 P. S. §  422.15(b)); and section 2(1) of the Professional Nursing Law (63 P. S. §  212(1)).

   The provisions of this §  18.57 adopted November 17, 2000, effective November 18, 2000, 30 Pa.B. 5943.

HEALTH CARE FACILITY POLICIES

§ 18.61. Institutional health care facility committee; committee
determination of standard policies and procedures.

 (a)  In health care facilities providing health services in which the practice of certified registered nurse practitioners involves the acts of medical diagnosis or prescription of medical therapeutic or corrective measures, there shall be 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 the practice of the nurses in the medical management of the patient.

 The committee shall review annually the effectiveness of the medical functions of the C.R.N.P. through an evaluation of the care rendered to patients using data sources such as patient records, statistics and patient follow-up.

ACCOUNTABILITY

§ 18.71. Accountability of C.R.N.P.

 The Certified Registered Nurse Practitioner shall be responsible for his own professional judgments and shall be accountable to the individual consumer. He shall also be accountable to the physician and the employing agency in the area of medical diagnosis and therapeutics.

TERMINATION OF APPROVAL

§ 18.81. Performance of tasks without direction; performance of tasks without training; other.

 The approval as provided in this subchapter for a Certified Registered Nurse Practitioner may be terminated by the State Board of Nursing when, after notice and hearing, that Board finds:

   (1)  That the registrant has engaged in the performance of medical functions and tasks other than at the direction of a physician licensed by the Board, except in situations as provided for in 42 Pa.C.S. §  8331 (relating to medical good Samaritan civil immunity).

   (2)  That the registrant has performed a medical task or function which the registrant is not qualified by education to perform.

MAINTENANCE OF CERTIFICATION

§ 18.91. Biennial certification.

 Applicants approved as Certified Registered Nurse Practitioners under this subchapter shall be certified biennially with the State Board of Nursing on forms provided by that Board on or before October 30 of the odd-numbered years.

FEES

§ 18.101. Reasonable fee determined by Board.

 The application for initial certification or biennial recertification shall be accompanied by a reasonable fee determined periodically by the State Board of Nursing.

PENALTIES FOR VIOLATION

§ 18.111. Penalties for violation.

 Certification as a C.R.N.P. may be suspended or revoked or the violator may be placed on probation as the Boards, or a joint committee thereof, determine after a formal hearing has been held, and a violation of the act and of The Professional Nursing Law (63 P. S. § §  211—225.5), of this subchapter or of Chapter 21 (relating to State Board of Nursing) has been adjudicated.

Subchapter D. PHYSICIAN ASSISTANTS

GENERAL PROVISIONS

Sec.

§ 18.121. Purpose.

 This subchapter implements section 13 of the act (63 P. S. §  422.13) pertaining to physician assistants and provides for the delegation of certain medical tasks to qualified physician assistants by supervising physicians when the delegation is consistent with the written agreement.

   The provisions of this §  18.121 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

   ARC-PA—The Accreditation Review Commission.

   Administration—The direct application of a drug, whole blood, blood components, diagnostic procedure or device, whether by injection, inhalation, ingestion, skin application or other means, into the body of a patient.

   CAAHEP—The Commission for Accreditation of Allied Health Educational Programs.

   CAHEA—The Committee on Allied Health Education and Accreditation.

   Device—An instrument or tool necessary in the administration of medication or medical care.

   Dispense—To deliver a drug or device to or for an ultimate user for limited or continuing use.

   Drug—A term used to describe a medication, device or agent which a physician assistant prescribes or dispenses under §  18.158 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).

   Emergency medical care setting—

     (i)   A health care setting which is established to provide emergency medical care as its primary purpose.

     (ii)   The term does not include a setting which provides general or specialized medical services that are not routinely emergency in nature even though that setting provides emergency medical care from time to time.

   Medical care facility—An entity licensed or approved to render health care services.

   Medical regimen—A therapeutic, corrective or diagnostic measure performed or ordered by a physician, or performed or ordered by a physician assistant acting within the physician assistant’s scope of practice, and in accordance with the written agreement between the supervising physician and the physician assistant.

   Medical service—An activity which lies within the scope of the practice of medicine and surgery.

   NCCPA—The National Commission on Certification of Physician Assistant.

   Order—An oral or written directive for a therapeutic, corrective or diagnostic measure, including a drug to be dispensed for onsite administration in a hospital, medical care facility or office setting.

   Physician—A medical doctor or doctor of osteopathic medicine.

   Physician assistant—An individual who is licensed as a physician assistant by the Board.

   Physician assistant examination—An examination to test whether an individual has accumulated sufficient academic knowledge to qualify for licensure as a physician assistant. The Board recognizes the certifying examination of the NCCPA.

   Physician assistant program—A program for the training and education of physician assistants which is recognized by the Board and accredited by the CAHEA, the CAAHEP, ARC-PA or a successor agency.

   Prescription—

     (i)   A written or oral order for a drug or device to be dispensed to or for an ultimate user.

     (ii)   The term does not include an order for a drug which is dispensed for immediate administration to the ultimate user; for example, an order to dispense a drug to a patient for immediate administration in an office or hospital is not a prescription.

   Primary supervising physician—A medical doctor who is registered with the Board and designated in the written agreement as having primary responsibility for directing and personally supervising the physician assistant.

   Satellite location—A location, other than the primary place at which the supervising physician provides medical services to patients, where a physician assistant provides medical services.

   Substitute supervising physician—A supervising physician who is registered with the Board and designated in the written agreement as assuming primary responsibility for a physician assistant when the primary supervising physician is unavailable.

   Supervising physician—Each physician who is identified in a written agreement as a physician who supervises a physician assistant.

   Supervision—

     (i)   Oversight and personal direction of, and responsibility for, the medical services rendered by a physician assistant. The constant physical presence of the supervising physician is not required so long as the supervising physician and the physician assistant are, or can be, easily in contact with each other by radio, telephone or other telecommunications device.

     (ii)   An appropriate degree of supervision includes:

       (A)   Active and continuing overview of the physician assistant’s activities to determine that the physician’s directions are being implemented.

       (B)   Immediate availability of the supervising physician to the physician assistant for necessary consultations.

       (C)   Personal and regular review within 10 days by the supervising physician of the patient records upon which entries are made by the physician assistant.

   Written agreement—The agreement between the physician assistant and supervising physician, which satisfies the requirements of §  18.142 (relating to written agreements).

   The provisions of this §  18.122 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.122 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (299570) and (222919) to (222920).

PHYSICIAN ASSISTANT EDUCATIONAL PROGRAMS

§ 18.131. Recognized educational programs/standards.

 (a)  The Board recognizes physician assistant educational programs accredited by the American Medical Association’s CAHEA, the CAAHEP, ARC-PA or a successor organization. Information regarding accredited programs may be obtained directly from ARC-PA at its website: www.arc-pa.org.

 (b)  The criteria for recognition by the Board of physician assistant educational programs will be identical to the essentials developed by the various organizations listed in this section or other accrediting agencies approved by the Board.

   The provisions of this §  18.131 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.132 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (114044).

LICENSURE OF PHYSICIAN ASSISTANTS AND
REGISTRATION OF SUPERVISING PHYSICIANS

§ 18.141. Criteria for licensure as a physician assistant.

 The Board will approve for licensure as a physician assistant an applicant who:

   (1)  Satisfies the licensure requirements in §  16.12 (relating to general qualifications for licenses and certificates).

   (2)  Has graduated from a physician assistant program recognized by the Board.

   (3)  Has submitted a completed application together with the required fee, under §  16.13 (relating to licensure, certification, examination and registration fees).

   (4)  Has passed the physician assistant examination.

   The provisions of this §  18.141 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.141 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222920) to (222921).

 (a)  The written agreement required by section 13(e) of the act (63 P. S. §  422.13(e)) satisfies the following requirements. The agreement must:

   (1)  Identify and be signed by the physician assistant and each physician the physician assistant will be assisting who will be acting as a supervising physician. At least one physician shall be a medical doctor.

   (2)  Describe the manner in which the physician assistant will be assisting each named physician. The description must list functions to be delegated to the physician assistant.

   (3)  Describe the time, place and manner of supervision and direction each named physician will provide the physician assistant, including the frequency of personal contact with the physician assistant.

   (4)  Designate one of the named physicians who shall be a medical doctor as the primary supervising physician.

   (5)  Require that the supervising physician shall countersign the patient record completed by the physician assistant within a reasonable amount of time. This time period may not exceed 10 days.

   (6)  Identify the locations and practice settings where the physician assistant will serve.

 (b)  The written agreement shall be approved by the Board as satisfying the requirements in subsection (a) and as being consistent with relevant provisions of the act and regulations contained in this subchapter.

 (c)  A physician assistant or supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the scope of the physician assistant’s authority.

   The provisions of this §  18.142 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.142 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222921) to (222922).

 (a)  The Board will register a supervising physician applicant who:

   (1)  Possesses a current license without restriction to practice medicine and surgery in this Commonwealth.

   (2)  Has filed a completed registration form accompanied by the written agreement (see §  18.142 (relating to written agreements)) and the required fee under §  16.13 (relating to licensure, certification, examination and registration fees). The registration requires detailed information regarding the physician’s professional background and specialties, medical education, internship, residency, continuing education, membership in American Boards of medical specialty, hospital or staff privileges and other information the Board may require.

   (3)  Includes with the registration, a list, identifying by name and license number, the other physicians who are serving as supervising physicians of the designated physician assistant under other written agreements.

 (b)  If the supervising physician plans to utilize physician assistants in satellite locations, the supervising physician shall provide the Board with supplemental information as set forth in §  18.155 (relating to satellite locations) and additional information requested by the Board directly relating to the satellite location.

 (c)  The Board will keep a current list of registered supervising physicians. The list will include the physician’s name, the address of residence, current business address, the date of filing, satellite locations if applicable, the names of current physician assistants under the physician’s supervision and the physicians willing to provide substitute supervision.

   The provisions of this §  18.143 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

 A primary supervising physician shall assume the following responsibilities. The supervisor shall:

   (1)  Monitor the compliance of all parties to the written agreement with the standards contained in the written agreement, the act and this subchapter.

   (2)  Advise any party to the written agreement of the failure to conform with the standards contained in the written agreement, the act and this subchapter.

   (3)  Arrange for a substitute supervising physician. (See §  18.154 (relating to substitute supervising physician).)

   (4)  Review directly with the patient the progress of the patient’s care as needed based upon the patient’s medical condition and prognosis or as requested by the patient.

   (5)  See each patient while hospitalized at least once.

   (6)  Provide access to the written agreement upon request and provide clarification of orders and prescriptions by the physician assistant relayed to other health care practitioners.

   (7)  Accept full professional and legal responsibility for the performance of the physician assistant and the care and treatment of the patients.

   The provisions of this §  18.144 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.144 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222923).

 (a)  A physician assistant shall register biennially according to the procedure in §  16.15 (relating to biennial registration; inactive status and unregistered status).

 (b)  The fee for the biennial registration of a physician assistant license is set forth in §  16.13 (relating to licensure, certification, examination and registration fees).

 (c)  To be eligible for renewal of a physician assistant license, the physician assistant shall maintain National certification by completing current recertification mechanisms available to the profession and recognized by the Board.

 (d)  The Board will keep a current list of persons licensed as physician assistants. The list will include:

   (1)  The name of each physician assistant.

   (2)  The place of residence.

   (3)  The current business address.

   (4)  The date of initial licensure, biennial renewal record and current supervising physician.

   The provisions of this §  18.145 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.145 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222923) to (222924).

   This section cited in 49 Pa. Code §  18.156 (relating to monitoring and review of physician assistant utilization).

PHYSICIAN ASSISTANT UTILIZATION

§ 18.151. Role of physician assistant.

 (a)  The physician assistant practices medicine with physician supervision. A physician assistant may perform those duties and responsibilities, including the ordering, prescribing, dispensing, and administration of drugs and medical devices, as well as the ordering, prescribing, and executing of diagnostic and therapeutic medical regimens, as directed by the supervising physician.

 (b)  The physician assistant may provide any medical service as directed by the supervising physician when the service is within the physician assistant’s skills, training and experience, forms a component of the physician’s scope of practice, is included in the written agreement and is provided with the amount of supervision in keeping with the accepted standards of medical practice.

 (c)  The physician assistant may pronounce death, but not the cause of death, and may authenticate with the physician assistant’s signature any form related to pronouncing death. If the attending physician is not available, the physician assistant shall notify the county coroner. The coroner has the authority to release the body of the deceased to the funeral director.

 (d)  The physician assistant may authenticate with the physician assistant’s signature any form that may otherwise be authenticated by a physician’s signature as permitted by the supervising physician, State or Federal law and facility protocol, if applicable.

 (e)  The physician assistant shall be considered the agent of the supervising physician in the performance of all practice-related activities including the ordering of diagnostic, therapeutic and other medical services.

   The provisions of this §  18.151 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.151 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222924) to (222925).

 (a)  A physician assistant may not:

   (1)  Provide medical services except as described in the written agreement.

   (2)  Prescribe or dispense drugs except as described in the written agreement.

   (3)  Maintain or manage a satellite location under §  18.155 (relating to satellite locations) unless the maintenance or management is registered with the Board.

   (4)  Independently practice or bill patients for services provided.

   (5)  Independently delegate a task specifically assigned to him by the supervising physician to another health care provider.

   (6)  List his name independently in a telephone directory or other directory for public use in a manner which indicates that he functions as an independent practitioner.

   (7)  Perform acupuncture except as permitted by section 13(k) of the act (63 P. S. §  422.13(k)).

   (8)  Perform a medical service without the supervision of a supervising physician.

 (b)  A supervising physician may not:

   (1)  Permit a physician assistant to engage in conduct proscribed in subsection (a).

   (2)  Have primary responsibility for more than two physician assistants.

   The provisions of this §  18.152 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

 (a)  A physician assistant may execute a written or oral order for a medical regimen or may relay a written or oral order for a medical regimen to be executed by a health care practitioner subject to the requirements of this section.

 (b)  As provided for in the written agreement, the physician assistant shall report orally or in writing, to a supervising physician, within 36 hours, those medical regimens executed or relayed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to execute or relay a medical regimen.

 (c)  The physician assistant shall record, date and authenticate the medical regimen on the patient’s chart at the time it is executed or relayed. When working in a medical care facility, a physician assistant may comply with the recordation requirement by directing the recipient of the order to record, date and authenticate that the recipient received the order, if this practice is consistent with the medical care facility’s written policies. The supervising physician shall countersign the patient record within a reasonable time not to exceed 10 days, unless countersignature is required sooner by regulation, policy within the medical care facility or the requirements of a third-party payor.

 (d)  A physician assistant or supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to relay a medical regimen or administer a therapeutic or diagnostic measure.

   The provisions of this §  18.153 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

 (a)  If the primary supervising physician is unavailable to supervise the physician assistant, the primary supervising physician may not delegate patient care to the physician assistant unless appropriate arrangements for substitute supervision are in the written agreement and the substitute physician is registered as a supervising physician with the Board.

 (b)  It is the responsibility of the substitute supervising physician to ensure that supervision is maintained in the absence of the primary supervising physician.

 (c)  During the period of supervision by the substitute supervising physician, the substitute supervising physician retains full professional and legal responsibility for the performance of the physician assistant and the care and treatment of the patients treated by the physician assistant.

 (d)  Failure to properly supervise may provide grounds for disciplinary action against the substitute supervising physician.

   The provisions of this §  18.154 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.154 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222927).

 (a)  Registration of satellite location. A physician assistant may not provide medical services at a satellite location unless the supervising physician has filed a registration with the Board.

 (b)  Contents of statement. A separate statement shall be made for each satellite location. The statement must demonstrate that:

   (1)  The physician assistant will be utilized in an area of medical need.

   (2)  There is adequate provision for direct communication between the physician assistant and the supervising physician and that the distance between the location where the physician provides services and the satellite location is not so great as to prohibit or impede appropriate support services.

   (3)  The supervising physician shall review directly with the patient the progress of the patient’s care as needed based upon the patient’s medical condition and prognosis or as requested by the patient.

   (4)  The supervising physician will visit the satellite location at least once every 10 days and devote enough time onsite to provide supervision and personally review the records of selected patients seen by the physician assistant in this setting. The supervising physician shall notate those patient records as reviewed.

 (c)  Failure to comply with this section. Failure to maintain the standards required for a satellite location may result not only in the loss of the privilege to maintain a satellite location but also may result in disciplinary action against the physician assistant and the supervising physician.

   The provisions of this §  18.155 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.155 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222927) to (222928).

 (a)  Representatives of the Board will be authorized to conduct scheduled and unscheduled onsite inspections of the locations where the physician assistants are utilized during the supervising physician’s office hours to review the following:

   (1)  Supervision of the physician assistant. See § §  18.144 and 18.154 (relating to responsibility of primary supervising physician; and substitute supervising physician).

   (2)  Presence of the written agreement and compliance with its terms. See §  18.142 (relating to written agreements).

   (3)  Utilization in conformity with the act, this subchapter and the written agreement.

   (4)  Appropriate identification of physician assistant. See §  18.171 (relating to physician assistant identification).

   (5)  Compliance with licensure and registration requirements. See § §  18.141 and 18.145 (relating to criteria for licensure as a physician assistant; and biennial registration requirements; renewal of physician assistant license).

   (6)  Maintenance of records evidencing patient and supervisory contact by the supervising physician.

 (b)  Reports shall be submitted to the Board and become a permanent record under the supervising physician’s registration. Deficiencies reported will be reviewed by the Board and may provide a basis for loss of the privilege to maintain a satellite location and disciplinary action against the physician assistant and the supervising physician.

 (c)  The Board reserves the right to review physician assistant utilization without prior notice to either the physician assistant or the supervising physician. It is a violation of this subchapter for a supervising physician or a physician assistant to refuse to comply with the request by the Board for the information in subsection (a).

 (d)  Additional inspections, including follow-up inspections may be conducted if the Board has reason to believe that a condition exists which threatens the public health, safety or welfare.

   The provisions of this §  18.156 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

 (a)  In a hospital, medical care facility or office setting, the physician assistant may order or administer, or both, controlled substances and whole blood and blood components if the authority to order and administer these medications and fluids is expressly set forth in the written agreement.

 (b)  The physician assistant shall comply with the minimum standards for ordering and administering controlled substances specified in §  16.92 (relating to prescribing, administering and dispensing controlled substances).

   The provisions of this §  18.157 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.157 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222929) to (222930).

 (a)  Prescribing, dispensing and administration of drugs.

   (1)  The supervising physician may delegate to the physician assistant the prescribing, dispensing and administering of drugs and therapeutic devices.

   (2)  A physician assistant may not prescribe or dispense Schedule I controlled substances as defined by section 4 of The Controlled Substances, Drug, Device, and Cosmetic Act (35 P. S. §  780-104).

   (3)  A physician assistant may prescribe a Schedule II controlled substance for initial therapy, up to a 72-hour dose. The physician assistant shall notify the supervising physician of the prescription as soon as possible, but in no event longer than 24 hours from the issuance of the prescription. A physician assistant may write a prescription for a Schedule II controlled substance for up to a 30-day supply if it was approved by the supervising physician for ongoing therapy. The prescription must clearly state on its face that it is for initial or ongoing therapy.

   (4)  A physician assistant may only prescribe or dispense a drug for a patient who is under the care of the physician responsible for the supervision of the physician assistant and only in accordance with the supervising physician’s instructions and written agreement.

   (5)  A physician assistant may request, receive and sign for professional samples and may distribute professional samples to patients.

   (6)  A physician assistant authorized to prescribe or dispense, or both, controlled substances shall register with the Drug Enforcement Administration (DEA).

 (b)  Prescription blanks. The requirements for prescription blanks are as follows:

   (1)  Prescription blanks must bear the license number of the physician assistant and the name of the physician assistant in a printed format at the heading of the blank. The supervising physician must also be identified as required in §  16.91 (relating to identifying information on prescriptions and orders for equipment and service).

   (2)  The signature of a physician assistant shall be followed by the initials ‘‘PA-C’’ or similar designation to identify the signer as a physician assistant. When appropriate, the physician assistant’s DEA registration number must appear on the prescription.

   (3)  The supervising physician is prohibited from presigning prescription blanks.

   (4)  The physician assistant may use a prescription blank generated by a hospital provided the information in paragraph (1) appears on the blank.

 (c)  Inappropriate prescription. The supervising physician shall immediately advise the patient, notify the physician assistant and, in the case of a written prescription, advise the pharmacy if the physician assistant is prescribing or dispensing a drug inappropriately. The supervising physician shall advise the patient and notify the physician assistant to discontinue using the drug and, in the case of a written prescription, notify the pharmacy to discontinue the prescription. The order to discontinue use of the drug or prescription shall be noted in the patient’s medical record by the supervising physician.

 (d)  Recordkeeping requirements. Recordkeeping requirements are as follows:

   (1)  When prescribing a drug, the physician assistant shall keep a copy of the prescription, including the number of refills, in a ready reference file, or record the name, amount and doses of the drug prescribed, the number of refills, the date of the prescription and the physician assistant’s name in the patient’s medical records.

   (2)  When dispensing a drug, the physician assistant shall record the physician assistant’s name, the name of the medication dispensed, the amount of medication dispensed, the dose of the medication dispensed and the date dispensed in the patient’s medical records.

   (3)  The physician assistant shall report, orally or in writing, to the supervising physician within 36 hours, a drug prescribed or medication dispensed by the physician assistant while the supervising physician was not physically present, and the basis for each decision to prescribe or dispense in accordance with the written agreement.

   (4)  The supervising physician shall countersign the patient record within 10 days.

   (5)  The physician assistant and the supervising physician shall provide immediate access to the written agreement to anyone seeking to confirm the physician assistant’s authority to prescribe or dispense a drug. The written agreement must list the categories of drugs which the physician assistant is not permitted to prescribe.

 (e)  Compliance with regulations relating to prescribing, administering, dispensing, packaging and labeling of drugs. A physician assistant shall comply with § §  16.92—16.94 (relating to prescribing, administering and dispensing controlled substances; packaging; and labeling of dispensed drugs) and Department of Health regulations in 28 Pa. Code § §  25.51—25.58 (relating to prescriptions) and regulations regarding packaging and labeling dispensed drugs. See §  16.94 and 28 Pa. Code § §  25.91—25.95 (relating to labeling of drugs, devices and cosmetics).

   The provisions of this §  18.158 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.158 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222930) to (222933).

 The supervising physician shall timely review, not to exceed 10 days, the medical records prepared by the physician assistant to ensure that the requirements of §  16.95 (relating to medical records) have been satisfied.

   The provisions of this §  18.159 issued under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.159 adopted August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222934).

MEDICAL CARE FACILITIES AND EMERGENCY
MEDICAL SERVICES

§ 18.161. Physician assistant employed by medical care facilities.

 (a)  A physician assistant may be employed by a medical care facility, but shall comply with the requirements of the act and this subchapter.

 (b)  The physician assistant may not be responsible to more than three supervising physicians in a medical care facility.

 (c)  This subchapter does not require medical care facilities to employ physician assistants or to permit their utilization on their premises. Physician assistants are permitted to provide medical services to the hospitalized patients of their supervising physicians if the medical care facility permits it.

 (d)  Physician assistants granted privileges by, or practicing in, a medical care facility shall conform to policies and requirements delineated by the facility.

   The provisions of this §  18.161 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

 (a)  A physician assistant may only provide medical service in an emergency medical care setting if the physician assistant has training in emergency medicine, functions within the purview of the physician assistant’s written agreement and is under the supervision of the supervising physician.

 (b)  A physician assistant licensed in this Commonwealth or licensed or authorized to practice in any other state who is responding to a need for medical care created by a declared state of emergency or a state or local disaster (not to be defined as an emergency situation which occurs in the place of one’s employment) may render care consistent with relevant standards of care.

   The provisions of this §  18.162 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.164 reserved August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780. Immediately preceding text appears at serial page (114053).

IDENTIFICATION AND NOTICE RESPONSIBILITIES

§ 18.171. Physician assistant identification.

 (a)  A physician assistant may not render medical services to a patient until the patient or the patient’s legal guardian has been informed that:

   (1)  The physician assistant is not a physician.

   (2)  The physician assistant may perform the service required as the agent of the physician and only as directed by the supervising physician.

   (3)  The patient has the right to be treated by the physician if the patient desires.

 (b)  It is the supervising physician’s responsibility to be alert to patient complaints concerning the type or quality of services provided by the physician assistant.

 (c)  In the supervising physician’s office and satellite locations, a notice plainly visible to patients shall be posted in a prominent place explaining that a ‘‘physician assistant’’ is authorized to assist a physician in the provision of medical care and services. The supervising physician shall display the registration to supervise in the office. The physician assistant’s license shall be prominently displayed at any location at which the physician assistant provides services. Duplicate licenses may be obtained from the Board if required.

 (d)  The physician assistant shall wear an identification tag which uses the term ‘‘Physician Assistant’’ in easily readable type. The tag shall be conspicuously worn.

   The provisions of this §  18.171 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.171 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial pages (222935) to (222936).

 (a)  The physician assistant is required to notify the Board, in writing, of a change in or termination of employment or a change in mailing address within 15 days. Failure to notify the Board, in writing, of a change in mailing address may result in failure to receive pertinent material distributed by the Board. The physician assistant shall provide the Board with the new address of residence, address of employment and name of registered supervising physician.

 (b)  The supervising physician is required to notify the Board, in writing, of a change or termination of supervision of a physician assistant within 15 days.

 (c)  Failure to notify the Board of changes in employment or a termination in the physician/physician assistant relationship is a basis for disciplinary action against the physician’s license, supervising physician’s registration and the physician assistant’s license.

   The provisions of this §  18.172 amended under sections 8, 13 and 36 of the Medical Practice Act of 1985 (63 P. S. § §  422.8, 422.13 and 422.36).

   The provisions of this §  18.172 amended August 13, 1993, effective August 14, 1993, 23 Pa.B. 3780; amended November 17, 2006, effective November 18, 2006, 36 Pa.B. 7009. Immediately preceding text appears at serial page (222936).

DISCIPLINE

§ 18.181. Disciplinary and corrective measures.

 (a)  A physician assistant who engages in unprofessional conduct is subject to disciplinary action under section 41 of the act (63 P. S. §  422.41). Unprofessional conduct includes the following:

   (1)  Misrepresentation or concealment of a material fact in obtaining a license or a reinstatement thereof.

   (2)  Commission of an offense against the statutes of the Commonwealth relating to the practice of physician assistants or regulations adopted thereunder.

   (3)  Commission of an act involving moral turpitude, dishonesty or corruption when the act directly or indirectly affects the health, welfare or safety of citizens of this Commonwealth. If the act constitutes a crime, conviction thereof in a criminal proceeding may not be a condition precedent to disciplinary action.

   (4)  Conviction of a felony or conviction of a misdemeanor relating to a health profession or receiving probation without verdict, disposition in lieu of trial or an accelerated rehabilitative disposition in the disposition of felony charges, in the courts of the Commonwealth, a Federal court or a court of another State, territory or country.

   (5)  Misconduct in practice as a physician assistant or performing tasks fraudulently, beyond its authorized scope, with incompetence, or with negligence on a particular occasion or negligence on repeated occasions.

   (6)  Performance of tasks as a physician assistant while the ability to do so is impaired by alcohol, drugs, physical disability or mental instability.

   (7)  Impersonation of a licensed physician or another licensed physician assistant.

   (8)  Offer, undertake or agree to cure or treat disease by a secret method, procedure, treatment or medicine; the treating, prescribing for a human condition, by a method, means or procedure which the physician assistant refuses to divulge upon demand of the Board; or use of methods or treatment which are not in accordance with treatment processes accepted by a reasonable segment of the medical profession.

   (9)  Violation of a provision of this subchapter fixing a standard of professional conduct.

   (10)  Continuation of practice while the physician assistant’s license has expired, is not registered or is suspended or revoked.

   (11)  Delegating a medical responsibility to a person when the physician assistant knows or has reason to know that the person is not qualified by training, experience, license or certification to perform the delegated task.

   (12)  The failure to notify the supervising physician that the physician assistant has withdrawn care from a patient.

 (b)  The Board will order the emergency suspension of the license of a physician assistant who presents an immediate and clear danger to the public health and safety, as required by section 40 of the act (63 P. S. §  422.40).

 (c)  The license of a physician assistant shall automatically be suspended, under conditions in section 40 of the act.

 (d)  The Board may refuse, revoke or suspend a physician’s registration as a supervising physician for engaging in any of the conduct proscribed of Board-regulated practitioners in section 41 of the act.

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