(a) An off-line medical director shall be:
  (1) a physician licensed to practice in Texas and shall be registered as an EMS medical director with the Texas Department of State Health Services;
  (2) familiar with the design and operation of EMS systems;
  (3) experienced in prehospital emergency care and emergency management of ill and injured patients;
  (4) actively involved in:
    (A) the training and/or continuing education of EMS personnel, under his or her direct supervision, at their respective levels of certification;
    (B) the medical audit, review, and critique of the performance of EMS personnel under his or her direct supervision;
    (C) the administrative and legislative environments affecting regional and/or state prehospital EMS organizations;
  (5) knowledgeable about local multi-casualty plans;
  (6) familiar with dispatch and communications operations of prehospital emergency units; and
  (7) knowledgeable about laws and regulations affecting local, regional, and state EMS operations.
(b) The off-line medical director shall be required to:
  (1) approve the level of prehospital care which may be rendered locally by each of the EMS personnel employed by and/or volunteering with the EMS under the medical director's supervision, regardless of the level of state certification or licensure, before the certificant or licensee is permitted to provide such care to the public;
  (2) establish and monitor compliance with field performance guidelines for EMS personnel;
  (3) establish and monitor compliance with training guidelines which meet or exceed the minimum standards set forth in the Texas Department of State Health Services EMS certification regulations;
  (4) develop, implement, and revise protocols and/or standing delegation orders, if appropriate, governing prehospital care and medical aspects of patient triage, transport, transfer, dispatch, extrication, rescue, and radio-telephone-telemetry communication by the EMS;
  (5) direct an effective system audit and quality assurance program;
  (6) determine standards and objectives for all medically related aspects of operation of the EMS including the inspection, evaluation, and approval of the system's performance specifications;
  (7) function as the primary liaison between the EMS administration and the local medical community, ascertaining and being responsive to the needs of each;
  (8) develop a letter or agreement or contract between the medical director(s) and the EMS administration outlining the specific responsibilities and authority of each. The agreement should describe the process or procedure by which a medical director may withdraw responsibility for EMS personnel for noncompliance with the Emergency Medical Services Act, the Health and Safety Code, Chapter 773, the rules adopted in this chapter, and/or accepted medical standards;
  (9) take or recommend appropriate remedial or corrective measures for EMS personnel, in conjunction with local EMS administration, which may include, but are not limited to, counseling, retraining, testing, probation, and/or field preceptorship;
  (10) suspend a certified EMS individual from medical care duties for due cause pending review and evaluation;
  (11) establish the circumstances under which a patient might not be transported;
  (12) establish the circumstances under which a patient may be transported against his or her will in accordance with state law, including approval of appropriate procedures, forms, and a review process;
  (13) establish criteria for selection of a patient's destination;
  (14) develop and implement a comprehensive mechanism for management of patient care incidents, including patient complaints, allegations of substandard care, and deviations from established protocols and patient care standards;
  (15) only approve care or activity that was provided at the time the medical director was employed, contracted or volunteering as a medical director;
  (16) notify the board at time of licensure registration under §166.1 of this title (relating to Physician Registration) of the physician's position as medical director and the names of all EMS providers for whom that physician holds the position of off-line medical director;
  (17) complete the following educational requirements:
    (A) within two years, either before or after initial notification to the board of holding the position as off-line medical director:
      (i) 12 hours of formal continuing medical education (CME) as defined under §166.2 of this title (relating to Continuing Medical Education) in the area of EMS medical direction;
      (ii) board certification in Emergency Medical Services by the American Board of Medical Specialties or a Certificate of Added Qualification in EMS by the American Osteopathic Association Bureau of Osteopathic Specialists; or
      (iii) a DSHS approved EMS medical director course; and
    (B) every two years after meeting the requirements of subparagraph (A) of this paragraph, one hour of formal CME in the area of EMS medical direction.
(c) A physician may not hold the position of off-line medical director:
  (1) for more than 20 EMS providers unless the physician obtains a waiver under subsection (d) of this section; or
  (2) for any EMS provider if the physician has been suspended or revoked for cause by any governmental agency or the physician has been excluded from Medicare, Medicaid, or CHIP.
(d) The board may grant a waiver to allow a physician to serve as an off-line medical director for more than 20 EMS providers, if the physician provides evidence that:
  (1) the Department of State Health Services has reviewed the waiver request and has determined that the waiver in the best interest of the public;
  (2) the physician is in compliance with this chapter, by submitting documentation of protocols and standing orders upon request; and
  (3) appropriate safeguards exist for patient care and adequate supervision of all EMS personnel under the physician's supervision.

Source Note: The provisions of this §197.3 adopted to be effective February 28, 1999, 24 TexReg 1157; amended to be effective January 9, 2003, 28 TexReg 73; amended to be effective September 20, 2007, 32 TexReg 6316; amended to be effective January 2, 2013, 37 TexReg 10213; amended to be effective May 6, 2013, 38 TexReg 2760