EMERGENCY RULES An agency may adopt a new or amended section or repeal an existing section on an emergency basis if it determines that such action is necessary for the public health, safety, or welfare of this state. The section may become effective immediately upon filing with the Texas Register, or on a stated date less than 20 days after filing and remaining in effect no more than 120 days. The emergency action is renewable once for no more than 60 additional days. Symbology in amended emergency sections. New language added to an existing section is indicated by the use of bold text. [Brackets] indicate deletion of existing material within a section. TITLE 22. EXAMINING BOARDS Part IX. Texas State Board of Medical Examiners Chapter 193. Standing Delegation Orders 22 TAC sec.sec.193.2-193.4, 193.8 The Texas State Board of Medical Examiners adopts on an emergency basis amendments to sec.sec.193.2-193.4 and 193.8, concerning standing delegation orders. These amendments will comply with changes made during the 74th Legislature through Senate Bill 1302 and Senate Bill 673. The amendments are adopted on an emergency basis under the Medical Practice Act, Texas Civil Statutes, Article 4495b, s2.09(a), which provide the Texas State Board of Medical Examiners with the authority to make rules, regulations and bylaws not inconsistent with this Act as may be necessary for the governing of its own proceedings, the performance of its duties, the regulation of the practice of medicine in this state, and the enforcement of this Act. In addition, this emergency rule is authorized by the Administrative Procedure Act, Texas Government Code, sec.2001.034. Reason for emergency-Since the changes made through Senate Bill 1302 and Senate Bill 673 regarding the delegation of prescriptive privileges were effective in June, 1995, and because these changes will have a profound effect on healthcare in Texas, it was felt necessary that these amendments should be adopted on an emergency basis to provide guidance to physicians in this area. Article 4495b, sec.3.06, is affected by this amendment. sec.193.2. Definitions. The following words and terms, when used in this chapter, shall have the following meanings, unless the contents clearly indicate otherwise. Advanced practice nurse-A registered nurse approved by the Texas State Board of Nurse Examiners to practice as an advanced practice nurse on the basis of completion of an advanced educational program. The term includes a nurse practitioner, a nurse midwife, nurse anesthetist, and clinical nurse specialist. Authorizing physician -A physician or physicians licensed by the board who execute a standing delegation order. Carrying out or signing
    a prescription drug order-To complete a prescription drug order presigned by the delegating physician, or the signing of a prescription by an advanced practice nurse or physician assistant after the person has been designated with the board by the delegating physician as a person delegated to sign a prescription. The following information shall be provided on each prescription:
      [by providing the following information:] the patient's name and address; the drug to be dispensed; directions to the patient for taking the drug; dosage; the intended use of the drug, if appropriate;
        the name, address, and telephone number of the physician; the name, address, telephone number, identification number, and signature of the physician assistant or advanced practice
          [registered] nurse completing or signing
            the prescription drug order; the date; and the number of refills permitted. This also includes the ability of a physician assistant or advanced practice nurse to telephone prescriptions in to a pharmacy under their prescriptive authority. Dangerous drug -A device or a drug that is unsafe for self medication and that is not included in the Texas Health and Safety Code, Schedules I-V or Penalty Groups I-IV of Chapter 481 (Texas Controlled Substances Act). The term includes a device or a drug that bears or is required to bear the legend: "Caution: federal law prohibits dispensing without prescription". Health professional
              [manpower] shortage area (HPSA)
                [(HMSA)]- (A) An area in an urban or rural area of Texas (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the delivery of health services) which the secretary of health and human services determines has a health manpower shortage and which is not reasonably accessible to an adequately served area; (B) a population group which the secretary determines to have such a shortage; or (C) a public or nonprofit private medical facility or other facility which the secretary determines has such a shortage as delineated in 42 U.S.C. sec.254(e)(a)(1).
                  [An area, population group, or facility designated by the United States Department of health and Human Services (USDHHS) as having a shortage of primary care physicians.] Medically underserved area (MUA)-An area or population group designated by the USDHHS as an area with a shortage of personal health services. Also includes an area defined by rule adopted by the Texas Board of Health that is based on demographics specific to this state, geographic factors that affect access to health care, and environmental health factors. Physician Assistant -A person who has graduated from a physician assistant or surgeon assistant training program accredited by the American Medical Association's Commission on Accreditation of Allied Health Education Programs and who has passed the certifying examination administered by the National Commission on Certification of Physician Assistants and who is licensed as a physician assistant by the Texas State Board of Physician Assistant Examiners. Physician's orders -The instructions of a physician for the care of an individual patient. Protocols-Standing delegation orders or standing medical orders authorizing a physician assistant or advanced practice
                    [registered] nurse to carry out prescription drug orders pursuant to the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5) and (6) and sec.193.8 of this title relating to the Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician assistants and Advanced Practice Nurses)
                      [(relating to Delegation of the Carrying Out of Prescription Drug Orders to Physician Assistants and Registered Nurses)] agreed upon and signed by the physician, the physician assistant and/or advanced practice
                        [registered] nurse which are reviewed and signed at least annually, are maintained at the site serving a medically underserved population, and contain a list of the types or categories of
                          dangerous drugs available for prescription, limitations on the number of dosage units and refills permitted, and instructions to be given the patient for follow-up monitoring or contain a list of dangerous drugs that may not be prescribed. Protocols shall be defined to promote the exercise of professional judgment by the advanced practice nurse and physician assistant commensurate with the ireducation and experience. The protocols used by a reasonable and prudent physician exercising sound medical judgment need not describe the exact steps that an advanced practice nurse or a physician assistant must take with respect to each specific condition, disease, or symptom. Site serving a medically underserved population -A site located in a medically underserved area; a site located in a health manpower shortage area; a rural health clinic designated under Public Law 95-210, the Rural Health Clinic Services Act of 1977; a public health clinic or a family planning clinic operating under contract with the Texas Department of Human Services or the Texas Department of Health; a site located in an area in which there exists an insufficient number of physicians providing services to eligible clients of federal, state, or locally funded health care programs, as determined by the Texas Department of Health; or a site that serves a disproportionate number of clients eligible to participate in federal, state, or locally funded health care programs, as determined by the Texas Department of Health. Standing delegation order-Written instructions, orders, rules, regulations, or procedures prepared by a physician and designed for a patient population with specific diseases, disorders, health problems, or sets of symptoms. Such written instructions, orders, rules, regulations or procedures shall delineate under what set of conditions and circumstances action should be instituted. These instructions, orders, rules, regulations or procedures are to provide authority for and a plan for use with patients presenting themselves prior to being examined or evaluated by a physician to assure that such acts are carried out correctly and are distinct from specific orders written for a particular patient, and shall be limited in scope of authority to be delegated as provided in sec.193.4 of this title (relating to Scope of Standing Delegation Orders). As used in this chapter, standing delegation orders do not refer to treatment programs ordered by a physician following examination or evaluation by a physician, nor to established procedures for providing of care by personnel under direct, personal supervision of a physician who is directly supervising or overseeing the delivery of medical or health care. Such standing delegation orders should be developed and approved by the physician who is responsible for the delivery of medical care covered by the orders. Such standing delegation orders, at a minimum, should: (A) include a written description of the method used in developing and approving them and any revision thereof; (B) be in writing, dated, and signed by the physician; (C) specify which acts require a particular level of training or licensure and under what circumstances they are to be performed; (D) state specific requirements which are to be followed by persons acting under same in performing particular functions; (E) specify any experience, training, and/or education requirements for those persons who shall perform such orders; (F) establish a method for initial and continuing evaluation of the competence of those authorized to perform same; (G) provide for a method of maintaining a written record of those persons authorized to perform same; (H) specify the scope of supervision required for performance of same, for example, immediate supervision of a physician; (I) set forth any specialized circumstances under which a person performing same is to immediately communicate with the patient's physician concerning the patient's condition; (J) state limitations on setting, if any, in which the plan is to be performed; (K) specify patient record-keeping requirements which shall, at a minimum, provide for accurate and detailed information regarding each patient visit; personnel involved in treatment and evaluation on each visit; drugs, or medications administered, prescribed or provided; and such other information which is routinely noted on patient charts and files by physicians in their offices; and (L) provide for a method of periodic review, which shall beat least annually, of such plan including the effective date of initiation and the date of termination of the plan after which date the physician shall issue a new plan. Standing medical orders-Orders, rules, regulations or procedures prepared by a physician or approved by a physician or the medical staff of an institution for patients which have been examined or evaluated by a physician and which are used as a guide in preparation for and carrying out medical or surgical procedures or both. These orders, rules, regulations or procedures are authority and direction for the performance for certain prescribed acts for patients by authorized persons as distinguished from specific orders written for a particular patient. sec.193.3. Exclusion from the Provisions of this Chapter. The provisions of this chapter shall not be applicable, nor shall they restrict the use of pre- established programs of health care, nor shall they restrict physicians from authorizing the provision of patient care by use of pre-established programs under the following circumstances: (1)-(7) (No change.) (8) Where care is to be delivered as authorized by the Medical Practice Act, Texas Civil Statutes, Article 4495b, s3.06(d)(5) or (6) except as provided in sec.193.8 of this title (relating to the Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician Assistants and Advanced Practice Nurses)
                            [(relating to Delegation of the Carrying Out of Prescription Drug Orders to Physician Assistants and Registered Nurses)]. sec.193.4. Scope of Standing Delegation Orders. Providing the authorizing physician is satisfied as to the ability and competence of those for whom the physician is assuming responsibility, and with due regard for the safety of the patient and in keeping with sound medical practice, standing delegation orders may be authorized for the performance of acts and duties which do not require the exercise of independent medical judgment. Limitations on the physician's use of standing delegation orders which are stated in this section shall not apply to patient care delivered as authorized by the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5) or (6),
                              or sec.193.8 of this title (relating to Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician Assistants and Advanced Practice Nurses
                                [(relating to Delegated Delivery of Health Care)]. When care is delivered under other circumstances, standing delegation orders may include authority to undertake the following: (1) (No change.) (2) The performance of an
                                  appropriate physical examination and the recording of physical findings. (3)-(8) (No change.) sec.193.8. Delegation of the Carrying Out or Signing of Prescription Drug Orders to Physician Assistants and Advanced Practice [Registered] Nurses. (a) Purpose. The purpose of this section is to provide guidelines for implementation of the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5) and (6)
                                    , which provide[s] for the use by physicians of standing delegation orders, standing medical orders, physician's order, or other orders or protocols in delegating authority to physician assistants or advanced practice
                                      [registered] nurses at sites serving medically underserved populations , at a physician's primary practice site, or at a site described in subsection (j) of this section
                                        . For purposes of this section, the term "advanced practice"
                                          [registered] nurse means a licensee of the Texas Board of Nurse Examiners who is approved to carry out a prescription drug order by that board. For purposes of this section, the term "physician assistant" means a licensee of the Texas State Board of Physician Assistants Examiners.
                                            In accord with Texas Civil Statutes, Article 4495b, sec.3.06(d)(5) and (6)
                                              , this section establishes minimum standards for supervision by physicians of physician assistants and advanced practice
                                                [registered] nurses for provision of services 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 and for
                                                  the use of prescriptions presigned by the supervising physician which may be carried out by a physician assistant or advanced practice
                                                    [registered] nurse according to protocols. [At sites serving medically underserved populations, such] Such
                                                      protocols may authorize diagnosis of the patient's condition and treatment, including prescription of dangerous drugs. Proper use of protocols requires integration of clinical data gathered by the physician assistant or advanced practice
                                                        [registered] nurse by means of the supervising physician's pre-existing written plan for determining a diagnosis and appropriate treatment. Neither the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5) or (6),
                                                          nor these rules authorize the exercise of independent medical judgment by physician assistants or advanced practice
                                                            [registered] nurses, and the supervising physician remains responsible to the board and to his or her patients for acts performed under the physician's delegated authority. Advanced practice nurses
                                                              [Registered nurses] and physician assistants
                                                                remain professionally responsible for acts performed under the scope and authority of their own licenses. (b) Physician Supervision at Site Serving Medically Underserved Populations.
                                                                  Physician supervision of a physician assistant or advanced practice
                                                                    [registered] nurse at a site serving a medically underserved population will be adequate if a delegating physician: (1) receives a daily status report to be conveyed in person, by telephone, or by radio from the advanced practice
                                                                      [registered] nurse or physician assistant on any complications or problems encountered that are not covered by a protocol; (2) visits the clinic in person at least once a week during regular business hours to observe and to provide medical direction and consultation to include, but not be limited to: (A) reviewing with the physician assistant or advanced practice
                                                                        [registered] nurse case histories of patients with problems or complications encountered
                                                                          [not covered by a protocol]; (B)-(C) (No change.) (3) is available by telephone or direct telecommunication for consultation, assistance with medical emergencies, or patient referrals [at all times the clinic is open]. (4) is responsible for the formulation of 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 patients under such orders. (c) Documentation of Supervision.
                                                                            Physician supervision shall be documented through a log kept at the clinic that includes 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. Said 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
                                                                              [registered] nurse. The supervising physician shall sign each log at the conclusion of each site visit. (d) Alternate Physicians.
                                                                                If a delegating physician will be unavailable to supervise the physician assistant or advanced practice
                                                                                  [registered] nurse as required by this section, arrangements shall be made for another physician to provide that supervision. The physician providing that supervision shall affirm in writing that he or she is familiar with the protocols or standing delegation orders in use at the clinic and is accountable for adequately supervising care provided pursuant to those protocols or standing delegation orders by fulfilling the requirements for registration as an alternate supervising physician as detailed in rules of the Texas State Board of Physician Examiners, 22 Texas Administrative Code, s185. (e) Supervision of Clinics.
                                                                                    A physician may not supervise more than three clinics without approval of the board. A physician may not supervise any number of clinics with combined regular business hours exceeding 150
                                                                                      [80] hours per week without approval of the board and with no supervision of a single clinic exceeding 50 hours per week. (f) Exceptions to Patient Chart Review.
                                                                                        Exceptions to the percentage of patient chart reviews required by subsection (b)(2)(C) of this section and the provisions of subsection (e) of this section relating to the number of clinics or clinic hours supervised may be made by the board upon special request by a delegating physician. Such a request shall state the special circumstances and needs prompting the exception, the names and locations of the clinics and/or hours to be supervised, and a plan of supervision. In granting an exception, the board shall state the percentage of charts that must be reviewed and/or the number of clinics or the combined clinic hours that can be supervised. (g) Delegation of Prescriptive Authority.
                                                                                          A physician may designate to
                                                                                            [authorize] a physician assistant or advanced practice nurse
                                                                                              [registered nurse to complete and issue prescriptions presigned] the act or acts of administering, providing, or carrying out or signing a prescription drug order as authorized
                                                                                                by the physician through physician's orders, standing medical orders, standing delegation orders, or other orders or protocols as defined by the board
                                                                                                  in treating patients at a site serving a medically underserved population. The prescription form itself shall comply with applicable rules adopted by the Texas State Board of Pharmacy. Prescriptions
                                                                                                    [Presigned Prescriptions] issued pursuant to this section may only be written for dangerous drugs. No prescriptions for controlled substances may be authorized or issued. An appropriate
                                                                                                      [A physician's] signature on one of the two signature lines on the prescription shall convey [his or her] instructions to a pharmacist regarding the pharmacist's authority to dispense a generically equivalent drug, if available. If the physician assistant or advanced practice nurse
                                                                                                        [a physician proposes to] authorize s
                                                                                                          generic substitution, the protocol shall provide direction to the physician assistant or advanced practice
                                                                                                            [registered] nurse as to whether and under what circumstances product selection will be permitted by a pharmacist. A delegating physician is responsible for devising and enforcing a system to account for and monitor the issuance of prescriptions under his supervision
                                                                                                              [use of presigned prescriptions]. (h) Violations.
                                                                                                                Violation of this section by the supervising physician may result in a refusal to approve supervision or
                                                                                                                  cancellation of the physician's authority to supervise a physician assistant or advanced practice
                                                                                                                    [registered] nurse under this section. Violation of this section may also subject the physician to disciplinary action as provided by the Medical Practice Act, Texas Civil Statutes, Article 4495b, s4.12 for violation of that Act, sec.3.08. If an advanced practice nurse
                                                                                                                      [a registered nurse] violates this section or the Medical Practice Act, Texas Civil Statutes, Article 4495b,sec.3.06(d)(5) or (6)
                                                                                                                        , the board shall promptly notify the Texas Board of Nurse Examiners of the alleged violation. If a physician assistant violates this section or the Medical Practice Act, Texas Civil Statutes, Article 4495b, sec.3.06(d)(5) or (6), the board shall promptly notify the Texas State Board of Physician Assistant Examiners. [The board may refuse to approve or may revoke its approval for a physician to supervise a physician assistant who has violated this section.] (i) Delegation at Primary Practice Site. At a physician's primary practice site or a location as described by subsection (j) of this section, a physician licensed 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 others 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 shall comply with other applicable laws. 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. (1) A physician's authority to delegate the carrying out or signing of a prescription drug order at his primary practice site under this section is limited to: (A) three physician assistants or advanced practice nurses or their full-time equivalents practicing at the physician's primary practice site; 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. (2) "Primary practice site" means: (A) the practice location where the physician spends the majority of the physician's time; (B) a licensed hospital, a licensed long-term care facility, and a licensed adult care center where both the physician and the physician assistant or advanced practice nurse are authorized to practice, or an established patient's residence; or (C) where the physician is physically present with the physician assistant or advanced practice nurse. (j) Delegation at Facility-Based Practice. A physician licensed 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. A physician's authority to delegate under this paragraph is limited as follows: (1) 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; (2) 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; (3) 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; (4) 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 three advanced practice nurses or physician assistants or their full-time equivalents; and (5) 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. (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 or issuance of a triplicate prescription form under the triplicate prescription program, sec.481.075, 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) three 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 Civil Statutes, Article 4542a-1). (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. (m) Liability. A physician shall not be liable for the actor 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. Issued in Austin, Texas, on September 13, 1995. TRD-9511719 Bruce A. Levy, M.D., J.D. Executive Director Texas State Board of Medical Examiners Effective date: September 13, 1995 Expiration date: January 11, 1995 For further information, please call: (512) 834-7728