SECTION 118.60. Consulting Physician--Responsibilities and Protocols

(a) The consulting physician shall be available for emergency consultation with the facility as appropriate to the circumstances, including, if the physician considers it necessary, an emergency appointment with the client.

(b) If the consulting physician is unavailable for an emergency consultation, another designated physician shall be available for the consultation with the facility relating to care for the client.

(c) The consulting physician and designated physician shall have a primary practice site located within seventy-five (75) miles of the LHR facility.

(d) The consulting physician shall be responsible for reviewing all adverse events and for determining whether such events are reportable in accordance with Title 21, CFR, Part 803.

(e) The protocols required in accordance with §118.30 shall be:

(1) written instructions agreed upon and signed and dated by the consulting physician and the LHR facility operator;

(2) maintained at the LHR facility; and

(3) reviewed and signed by the consulting physician and LHR operator at least annually.

(f) The protocols required in accordance with §118.30, shall include at least the following:

(1) which LHR procedures require a particular level of individual LHR certification;

(2) the circumstances or conditions under which each procedure is to be performed;

(3) specific instructions to be followed for individual LHR certificate holders who are working under direct supervision or who are giving direct supervision;

(4) conditions under which emergency consultation is required;

(5) designated settings, in accordance with the manufacturer's instructions, at which the LHR device can be expected to safely remove hair; and

(6) list of medications taken by the client that should be reported to the consulting physician before LHR services are provided or that, if taken by the client, preclude a LHR procedure from being performed.

(g) The requirements in this section do not relieve a consulting physician or another health care professional from complying with applicable regulations prescribed by a state or federal agency.

Source Note: The provisions of this §118.60 adopted to be effective November 1, 2017, 42 TexReg 4815