Document Citation: 22 TAC § 193.6

Header:

TEXAS ADMINISTRATIVE CODE
TITLE 22. EXAMINING BOARDS
PART 9. TEXAS MEDICAL BOARD
CHAPTER 193. STANDING DELEGATION ORDERS


Date:
08/31/2009

Document:

§ 193.6. Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician Assistants and Advanced Practice Nurses

(a) Purpose. The purpose of this section is to provide guidelines for implementation of the Medical Practice Act ("the Act"), Texas Occupations Code Annotated, §§ 157.051 -157.060, which provide for the use by physicians of standing delegation orders, standing medical orders, physician's orders, or other orders or protocols in delegating authority to physician assistants or advanced practice nurses at a site serving medically underserved populations, at a physician's primary practice or alternate practice site, or at a facility-based practice site. This section establishes minimum standards for supervision by physicians when delegating prescriptive authority to physician assistants and advanced practice nurses at such sites. This section also provides for the signing of a prescription by an advanced practice nurse or a physician assistant after the person has been designated by the delegating physician as a person delegated to sign a prescription which may be carried out by a physician assistant or advanced practice nurse according to protocols. Such protocols may authorize diagnosis of the patient's condition and treatment, including prescription of dangerous drugs or controlled substances Schedules III - V as provided under subsection (n) of this section. Proper use of protocols allows integration of clinical data gathered by the physician assistant or advanced practice nurse. Neither the Act, §§ 157.051 - 157.060, nor these rules authorize the exercise of independent medical judgment by physician assistants or advanced practice nurses, and the delegating physician remains responsible to the board and to his or her patients for acts performed under the physician's delegated authority. Advanced practice nurses and physician assistants remain professionally responsible for acts performed under the scope and authority of their own licenses.

(b) Delegation of prescriptive authority at site serving underserved populations.

(1) Acts that may be delegated. At a site serving a medically underserved population, a physician authorized by the board may delegate to a physician assistant or an advanced practice nurse the act or acts of administering, providing, or carrying out or signing a prescription drug order as authorized through physician's orders, standing medical orders, standing delegation orders, or other orders or protocols as defined by the board. Providing and carrying out or signing a prescription drug order under this subdivision is limited to dangerous drugs and controlled substances Schedules III - V as provided under subsection (n) of this section, and shall comply with other applicable laws.

(2) Physician supervision at site serving medically underserved populations. Physician supervision of a physician assistant or an advanced practice nurse at a site serving a medically underserved population will be adequate if a delegating physician:

(A) receives a daily status report to be conveyed in person, by telephone, or by radio from the advanced practice nurse or physician assistant on any complications or problems encountered that are not covered by a protocol;

(B) visits the clinic in person at least once every ten business days during regular business hours during which the advanced practice nurse or physician assistant is on site providing care, in order to observe and provide medical direction and consultation to include, but not be limited to: (i) reviewing with the physician assistant or advanced practice nurse the case histories of patients with problems or complications encountered; (ii) personally diagnosing or treating patients requiring physician follow-up; and (iii) verifying that patient care is provided by the clinic in accordance with a written quality assurance plan on file at the clinic, which includes a random review and countersignature of at least 10% of the patient charts by the physician;

(C) is available by telephone or direct telecommunication for consultation, assistance with medical emergencies, or patient referrals; and

(D) is responsible for the formulation or approval of such physician's orders, standing medical orders, standing delegation orders, or other orders or protocols and periodically reviews such orders and the services provided to patients under such orders.

(3) Supervision of clinics. A physician may not supervise more than three clinics serving medically underserved populations without approval of the board. A physician may not supervise any number of clinics with combined regular business hours exceeding 150 concurrent hours per week without approval of the board.

(c) Delegation of prescriptive authority at primary practice site.

(1) "Primary practice site" means:

(A) the practice location where the physician spends the majority of the physician's time;

(B) a licensed hospital, long-term care facility, or adult care center where both the physician and the physician assistant or advanced practice nurse are authorized to practice;

(C) a clinic operated by or for the benefit of a public school district for the purpose of providing care to the students of that district and the siblings of those students, if consent to treatment at that clinic is obtained in a manner that complies with the Family Code, Chapter 32;

(D) an established patient's residence;

(E) where the physician is physically present with the physician assistant or advanced practice nurse; or

(F) a location where a physician assistant or advanced practice nurse who practices on-site with the physician more than 50 percent of the time and provides: (i) health care services for established patients; (ii) without remuneration, voluntary charity health care services at a clinic run or sponsored by a nonprofit organization; or (iii) without remuneration, voluntary health care services during a declared emergency or disaster at a temporary facility operated or sponsored by a governmental entity or nonprofit organization and established to serve persons in Texas.

(2) Acts that may be delegated. At a physician's primary practice site, a licensed physician authorized by the board may delegate to a physician assistant or an advanced practice nurse acting under adequate physician supervision the act or acts of administering, providing, carrying out or signing a prescription drug order as authorized through physician's orders, standing medical orders, standing delegation orders, or other orders or protocols as defined by the board. Providing and carrying out or signing a prescription drug order under this subdivision is limited to dangerous drugs and controlled substances Schedules III - V as provided in subsection (n) of this section, and shall comply with other applicable laws.

(3) Physician supervision. Physician supervision of the carrying out and signing of prescription drug orders shall conform to what a reasonable, prudent physician would find consistent with sound medical judgment but may vary with the education and experience of the advanced practice nurse or physician assistant. A physician shall provide continuous supervision, but the constant physical presence of the physician is not required.

(4) Additional limitations. A physician's authority to delegate the carrying out or signing of a prescription drug order under this subsection is limited to:

(A) four physician assistants or advanced practice nurses or their full-time equivalents practicing at the physician's primary or alternate practice site, unless a waiver is granted under subsection (i) of this section; and

(B) the patients with whom the physician has established or will establish a physician-patient relationship, but this shall not be construed as requiring the physician to see the patient within a specific period of time.

(d) Delegation of prescriptive authority at a physician's alternate practice site.

(1) "Alternate practice site" means a site:

(A) where services similar to the services provided at the delegating physician's primary practice site are provided; and

(B) located within 75 miles of the delegating physician's residence or primary practice site.

(2) Acts that may be delegated. At a physician's alternate practice site, a licensed physician authorized by the board may delegate to a physician assistant or an advanced practice nurse acting under adequate physician supervision the act or acts of administering, providing, carrying out or signing a prescription drug order as authorized through physician's orders, standing medical orders, standing delegation orders, or other orders or protocols as defined by the board. Providing, carrying out or signing a prescription drug order under this subsection is limited to dangerous drugs and controlled substances Schedules III - V as provided in subsection (n) of this section, and shall comply with other applicable laws.

(3) Physician supervision is adequate for the purposes of this subsection if the delegating physician:

(A) is on-site with the advanced practice nurse or physician assistant at least 10 percent of the hours of operation of the site each month that the physician assistant or advanced practice nurse is acting with delegated prescriptive authority and is available while on-site to see, diagnose, treat, and provide care to those patients for services provided to or to be provided by the physician assistant or advanced practice nurse to whom the physician has delegated prescriptive authority;

(B) randomly reviews at least 10 percent of the medical charts, including through electronic review of the charts from a remote location, of patients seen by a physician assistant or advanced practice nurse at the site;

(C) is available through direct telecommunication for consultation, patient referral, or assistance with a medical emergency; and

(D) is not prohibited by contract from seeing, diagnosing, or treating a patient for services provided or to be provided by the physician assistant or advanced practice nurse under delegated prescriptive authority.

(4) A physician may not delegate to a combined number of more than four physician assistants or advanced practice nurses or their full-time equivalents at the physician's primary and alternate practice sites, unless a waiver is granted under subsection (i) of this section.

(e) Delegation of prescriptive authority at a facility-based practice site.

(1) Acts that may be delegated. A licensed physician authorized by the board shall be authorized to delegate, to one or more physician assistants or advanced practice nurses acting under adequate physician supervision whose practice is facility based at a licensed hospital or licensed long-term care facility, the carrying out or signing of prescription drug orders if the physician is the medical director or chief of medical staff of the facility in which the physician assistant or advanced practice nurse practices, the chair of the facility's credentialing committee, a department chair of a facility department in which the physician assistant or advanced practice nurse practices, or a physician who consents to the request of the medical director or chief of medical staff to delegate the carrying out or signing of prescription drug orders at the facility in which the physician assistant or advanced practice nurse practices. Providing and carrying out or signing a prescription drug order under this subdivision is limited to dangerous drugs and controlled substances Schedules III - V as provided in subsection (n) of this section, and shall comply with other applicable laws.

(2) Limitations on authority to delegate. A physician's authority to delegate under this subsection is limited as follows:

(A) the delegation is pursuant to a physician's order, standing medical order, standing delegation order, or other order or protocol developed in accordance with policies approved by the facility's medical staff or a committee thereof as provided in facility bylaws;

(B) the delegation occurs in the facility in which the physician is the medical director, the chief of medical staff, the chair of the credentialing committee, or a department chair;

(C) the delegation does not permit the carrying out or signing of prescription drug orders for the care or treatment of the patients of any other physician without the prior consent of that physician;

(D) delegation in a long-term care facility must be by the medical director and the medical director is limited to delegating the carrying out and signing of prescription drug orders to no more than four advanced practice nurses or physician assistants or their full-time equivalents; and

(E) under this section, a physician may not delegate at more than one licensed hospital or more than two long-term care facilities unless approved by the board.

(3) Physician supervision. Physician supervision of the carrying out and signing of a prescription drug order shall conform to what a reasonable, prudent physician would find consistent with sound medical judgment but may vary with the education and experience of the advanced practice nurse or physician assistant. A physician shall provide continuous supervision, but the constant physical presence of the physician is not required.

(f) Documentation of supervision.

(1) A physician shall document any delegation of prescriptive authority to a physician assistant or advanced practice nurse by a protocol, as defined in this section. The physician shall also maintain a permanent record of all protocols the physician has signed, showing to whom the delegation was made and the dates of the original delegation, each annual review, and termination.

(2) If the physician assistant or advanced practice nurse is located at a site other than the site where the physician spends the majority of the physician's time, physician supervision shall be further documented by a permanent record showing the names or identification numbers of patients discussed during the daily status reports, the times when the physician is on site, and a summary of what the physician did while on site. The summary shall include a description of the quality assurance activities conducted and the names of any patients seen or whose case histories were reviewed with the physician assistant or advanced practice nurse. The supervising physician shall sign the documentation at the conclusion of each site visit. Documentation is not required if the physician assistant or advanced practice nurse is permanently located with the physician at a site where the physician spends the majority of the physician's time.

(3) Physicians that delegate the carrying out or signing of a prescription drug order must register with the board the name and license number of the physician assistant or advanced practice nurse to whom the delegation is made. A physician who delegates to a certified registered nurse anesthetist the ordering of drugs and devices necessary for the certified registered anesthetist to administer an anesthetic or an anesthesia-related service is not required to register the name and license number of the certified registered nurse anesthetist with the board.

(g) Alternate physicians. If a delegating physician will be unavailable to supervise the physician assistant or advanced practice nurse as required by this section, arrangements shall be made for another physician to provide that supervision. The alternate (substitute) physician providing that supervision shall affirm in writing and document through a permanent record where the physician assistant or advanced practice nurse is located that he or she is familiar with the protocols or standing delegation orders in use and is accountable for adequately supervising prescriptive delegation provided pursuant to those protocols or standing delegation orders. The permanent record shall be kept with the protocols or standing orders. The permanent record shall contain dates of the alternate physician supervision and be signed by the alternate physician acknowledging this responsibility. The physician assistant or advanced practice nurse is responsible for verifying that the alternate physician is a licensed Texas physician holding an unrestricted and active license.

(h) Prescription forms. Prescription forms shall comply with applicable rules adopted by the Texas State Board of Pharmacy. Prescriptions issued pursuant to this section may only be written for dangerous drugs and controlled substances Schedules III - V as provided in subsection (n) of this section. A delegating physician is responsible for devising and enforcing a system to account for and monitor the issuance of prescriptions under the physician's supervision.

(i) Waivers.

(1) The board may waive or modify any of the site or supervision requirements for a physician to delegate the carrying out or signing of prescription drug orders to an advanced practice nurse of physician assistant at facilities serving medically underserved populations, at physician primary and alternate practice sites, and at facility-based practice sites.

(2) The board may grant a waiver under paragraph (1) of this subsection if the board determines that:

(A) the practice site where the physician is seeking to delegate prescriptive authority is unable to meet the requirements of Chapter 157 of the Act or this section, or compliance would cause an undue burden without a corresponding benefit to patient care;

(B) safeguards exist for patient care and for fostering a collaborative practice between the physician and the advanced practice nurses and physician assistants; and

(C) if the requirement for which the waiver is sought is the amount of time the physician is on-site, the frequency and duration of time the physician is on-site when the advanced practice nurse or physician assistant is present is sufficient for collaboration to occur, taking into consideration the other ways the physician collaborates with the advanced practice nurse or physician assistant at other sites.

(3) If the board determines that the types of health care services provided by a physician assistant or advanced practice nurse at an alternate practice site as described in subsection (d) of this section are limited in nature and duration and are within the scope of delegated authority, and that patient health care will not be adversely affect, the board may modify or waive:

(A) the limitation on the number of physician assistants or advanced practice nurses, or their full-time equivalents, if the board does not authorize more than six physician assistants or advanced practice nurses or their full-time equivalents;

(B) the mileage limitation; or

(C) the onsite-supervision requirements, except that the physician must be available on-site at regular intervals and when on-site must be available to treat patients.

(4) The board may not waive the limitation on the number of primary or alternate practice sites at which a physician may delegate the carrying out or signing of prescription drug orders or the number of advanced practice nurses or physician assistants to whom a physician may delegate the carrying out or signing of prescription drugs orders, except as provided in paragraph (3)(A) of this subsection.

(5) Procedure.

(A) A physician may apply for a waiver by submitting a written request to the licensure division of the board via the agency website, email, or regular mail. The request shall then be submitted to the board for review.

(B) The Standing Orders Committee of the board shall review requests for waivers and may recommend to the full board that a waiver be granted, denied or modified.

(C) The board may grant a waiver only if the board determines good cause exists to grant a waiver.

(D) The board may approve a waiver with modifications.

(E) If the board denies a waiver, a written explanation for the denial shall be given to the physician along with any recommended modifications that would make the waiver application acceptable.

(F) The board may revoke, suspend or modify a waiver previously granted after providing the physician notice and opportunity for a hearing as provided for by the Administrative Procedure Act and Chapter 187 of this title (relating to Procedural Rules).

(6) A modification or waiver granted under this subsection may not validate or authorize a contract provision that prohibits a physician from seeing, diagnosing, or treating any patient.

(j) Violations. Violation of this section by the delegating physician may result in a refusal to approve supervision or the cancellation of the physician's authority to delegate to a physician assistant or an advanced practice nurse under this section. Violation of this section may also subject the physician to disciplinary action as provided by the Act, § 164.001, for violation of § 164.051. If an advanced practice nurse violates this section or the Act, §§ 157.051 - 157.060, the board shall promptly notify the Texas Board of Nurse Examiners of the alleged violation. If a physician assistant violates this section or the Act, §§ 157.051 - 157.060, the board shall promptly notify the Texas Physician Assistant Board.

(k) Delegation to certified registered nurse anesthetists.

(1) In a licensed hospital or ambulatory surgical center a physician may delegate to a certified registered nurse anesthetist the ordering of drugs and devices necessary for a certified registered nurse anesthetist to administer an anesthetic or an anesthesia-related service ordered by the physician. The physician's order for anesthesia or anesthesia-related services does not have to be drug-specific, dose-specific, or administration-technique-specific. Pursuant to the order and in accordance with facility policies or medical staff bylaws, the nurse anesthetist may select, obtain, and administer those drugs and apply the appropriate medical devices necessary to accomplish the order and maintain the patient within a sound physiological status.

(2) This paragraph shall be liberally construed to permit the full use of safe and effective medication orders to utilize the skills and services of certified registered nurse anesthetists.

(l) Delegation related to obstetrical services.

(1) A physician may delegate to a physician assistant offering obstetrical services and certified by the board as specializing in obstetrics or an advanced practice nurse recognized by the Texas State Board of Nurse Examiners as a nurse midwife the act or acts of administering or providing controlled substances to the nurse midwife's or physician assistant's clients during intra-partum and immediate post-partum care. The physician shall not delegate the use of a prescription sticker or the use or issuance of an official prescription form relating to the prescription of Schedule II controlled substance as described under § 481.075 of the Health and Safety Code.

(2) The delegation of authority to administer or provide controlled substances under this paragraph must be under a physician's order, medical order, standing delegation order, or protocol which shall require adequate and documented availability for access to medical care.

(3) The physician's orders, medical orders, standing delegation orders, or protocols shall provide for reporting or monitoring of client's progress including complications of pregnancy and delivery and the administration and provision of controlled substances by the nurse midwife or physician assistant to the clients of the nurse midwife or physician assistant.

(4) The authority of a physician to delegate under this paragraph is limited to:

(A) four nurse midwives or physician assistants or their full-time equivalents; and

(B) the designated facility at which the nurse midwife or physician assistant provides care.

(5) The administering or providing of controlled substances under this paragraph shall comply with other applicable laws.

(6) In this paragraph, "provide" means to supply one or more unit doses of a controlled substance for the immediate needs of a patient not to exceed 48 hours.

(7) The controlled substance shall be supplied in a suitable container that has been labeled in compliance with the applicable drug laws and shall include the patient's name and address; the drug to be provided; the name, address, and telephone number of the physician; the name, address, and telephone number of the nurse midwife or physician assistant; and the date.

(8) This paragraph does not permit the physician or nurse midwife or physician assistant to operate a retail pharmacy as defined under the Texas Pharmacy Act Texas Occupations Code Annotated Subtitle J.

(9) This paragraph shall be construed to provide a physician the authority to delegate the act or acts of administering or providing controlled substances to a nurse midwife or physician assistant but not as requiring physician delegation of further acts to a nurse midwife or as requiring physician delegation of the administration of medications to registered nurses or physician assistants other than as provided in this paragraph.

(10) This subsection does not limit the authority of a physician to delegate the carrying out or signing of a prescription drug order involving a controlled substance under subsection (n) of this section.

(m) Liability. A physician shall not be liable for the act or acts of a physician assistant or advanced practice nurse solely on the basis of having signed an order, a standing medical order, a standing delegation order, or other order or protocols authorizing a physician assistant or advanced practice nurse to perform the act or acts of administering, providing, carrying out, or signing a prescription drug order unless the physician has reason to believe the physician assistant or advanced practice nurse lacked the competency to perform the act or acts.

(n) Prescription Drug Orders.

(1) Pursuant to the Medical Practice Act, Texas Occupations Code Annotated § 157.0511, a physician's authority to delegate the carrying out or signing of a prescription drug order is limited to:

(A) dangerous drugs; and

(B) controlled substances to the extent provided in paragraph (2) of this subsection.

(2) A physician may delegate the carrying out or signing of a prescription drug order for a controlled substance only if:

(A) the prescription is for a controlled substance listed in Schedule III, IV, or V as established under Chapter 481 of the Texas Health and Safety Code;

(B) the prescription, including a refill of the prescription, is for a period not to exceed 90 days;

(C) with regard to the refill of a prescription, the refill is authorized after consultation with the delegating physician and the consultation is noted in the patient's chart; and

(D) with regard to a prescription for a child less than two years of age, the prescription is made after consultation with the delegating physician and the consultation is noted in the patient's chart.