| (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.
|
