25 Tex. Admin. Code § 135.62 - Inspections
(a) The Texas Health and Human Services
Commission (HHSC) may conduct an unannounced, on-site inspection of an
ambulatory surgical center (ASC) at any reasonable time, including when
treatment services are provided, to inspect, investigate, or evaluate
compliance with or prevent a violation of:
(1) any applicable statute or rule;
(2) an ASC's plan of correction;
(3) an order or special order of the HHSC
executive commissioner or the executive commissioner's designee;
(4) a court order granting injunctive relief;
or
(5) for other purposes relating
to regulation of the ASC.
(b) An applicant or licensee, by applying for
or holding a license, consents to entry and inspection of any of its ASCs by
HHSC.
(c) HHSC inspections to
evaluate an ASC's compliance may include:
(1)
initial, change of ownership, or relocation inspections for the issuance of a
new license;
(2) inspections
related to changes in status, such as new construction or changes in services,
designs, or bed numbers;
(3)
routine inspections, which may be conducted without notice and at HHSC's
discretion, or prior to renewal;
(4) follow-up on-site inspections, conducted
to evaluate implementation of a plan of correction for previously cited
deficiencies;
(5) inspections to
determine if an unlicensed ASC is offering or providing, or purporting to offer
or provide, treatment; and
(6)
entry in conjunction with any other federal, state, or local agency's
entry.
(d) An ASC shall
cooperate with any HHSC inspection and shall permit HHSC to examine the ASC's
grounds, buildings, books, records, video surveillance, and other documents and
information maintained by or on behalf of the ASC, unless prohibited by
law.
(e) An ASC shall permit HHSC
access to interview members of the governing body, personnel, and patients,
including the opportunity to request a written statement.
(f) An ASC shall permit HHSC to inspect and
copy any requested information, unless prohibited by law. If it is necessary
for HHSC to remove documents or other records from the ASC, HHSC provides a
written description of the information being removed and when it is expected to
be returned. HHSC makes a reasonable effort, consistent with the circumstances,
to return any records removed in a timely manner.
(g) HHSC shall maintain the confidentiality
of ASC records as applicable under state and federal law.
(h) Upon entry, HHSC holds an entrance
conference with the ASC's designated representative to explain the nature,
scope, and estimated duration of the inspection.
(i) During the inspection, the HHSC
representative gives the ASC representative an opportunity to submit
information and evidence relevant to matters of compliance being
evaluated.
(j) When an inspection
is complete, the HHSC representative holds an exit conference with the ASC
representative to inform the facility representative of any preliminary
findings of the inspection, including any possible health and safety concerns.
The ASC may provide any final documentation regarding compliance during the
exit conference.
Notes
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