| (a) The consulting physician shall conduct audits of
the registrant's LHR facility to ensure that operations are being
conducted in accordance with the protocols established by the contract
specified in §118.30.
(b) The audits shall be unannounced, shall be conducted
at the physical site of the LHR facility, and shall be conducted at
least quarterly.
(c) The audits may be scheduled in advance if the consulting
physician determines that advance notice does not compromise the ability
to determine that operations are being conducted in accordance with
established protocols.
(d) The audits may be conducted by the consulting physician,
another designated physician or an advanced practice nurse or physician's
assistant acting under the consulting physician's delegated authority.
(e) If the audit is conducted by an advanced practice
nurse or physician's assistant, the consulting physician shall sign
the audit.
(f) The consulting physician shall make records of
audits conducted under the terms of the contract and maintain those
records in accordance with the requirements of this chapter. The consulting
physician audit records shall be maintained in accordance with this
chapter.
(g) The record of the audit shall include at least
the following:
(1) date audit was performed;
(2) name of the LHR facility audited;
(3) assessment of the LHR facility's performance of
the protocols established by the written contract; and
(4) signature of the consulting physician, the LHR
facility operator, and any other designated physician or advanced
practice nurse or physician's assistant acting under the consulting
physician's delegated authority to conduct the audit.
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