Current through Reg. 50, No. 13; March 28, 2025
(a) The department shall conduct an on-site
inspection to evaluate the ambulatory surgical center's (ASC's) compliance with
the standards for licensing set forth in these sections.
(1) The department shall evaluate the ASC on
a standard-by-standard basis before the first renewal license is issued, unless
waived in accordance with § 135.20(e)(4) of this title (relating to
Initial Application and Issuance of License).
(2) An on-site licensing inspection may be
conducted once every three years.
(3) The department may make any survey or
investigation that it considers necessary. A department representative(s) may
enter the premises of a facility at any reasonable time to make a survey or an
investigation to ensure compliance with or prevent a violation of Health and
Safety Code, Chapter 243, an order or special order of the commissioner, a
special license provision, a court order granting injunctive relief, or other
enforcement procedures. Ensuring compliance includes permitting photocopying of
any records or other information by or on behalf of the department as necessary
to determine or verify compliance with the statute or rules adopted under the
statute, except that the department may not photocopy, reproduce, remove or
dictate from any part of the root cause analysis or action plan required in
§135.27 of this title (relating to Patient Safety Program).
(b) If an on-site inspection is
conducted at an ASC and deficiencies are cited, the surveyor shall request the
applicant or person in charge to sign the statement of deficiencies as an
acknowledgment of receipt of a copy of the statement of deficiencies. Signing
the statement of deficiencies does not indicate agreement with any
deficiencies. If the applicant or person in charge declines to sign the form,
the surveyor shall note the declination on the statement of deficiencies and
the name of the person so declining. The surveyor shall leave a copy of the
statement of deficiencies at the ASC and, if the person in charge is not the
applicant, mail a copy of the statement of deficiencies to the
applicant.
(c) After an inspection
is completed, the surveyor shall prepare a survey report which contains the
following:
(1) a completed survey report
form;
(2) a statement of which
standards were evaluated;
(3) a
statement of deficiencies, if any, and the signature of the applicant or person
in charge;
(4) a plan of correction
which has been provided by the ASC and the date(s) by which correction(s) will
be made; and
(5) any comments by
the applicant or person in charge concerning the survey.
(d) The survey report form shall be submitted
as follows.
(1) The surveyor shall submit the
survey report to their supervisor for evaluation and decision.
(2) A license shall be issued to an ASC that
is in compliance with minimum standards in accordance with these sections at
the time of the on-site inspection.
(3) If deficiencies are cited and the plan of
correction is acceptable, written notice shall be sent to the applicant
acknowledging same.
(4) If
deficiencies are cited and the plan of correction is not acceptable, the
department shall notify the applicant in writing and request that the plan of
correction be resubmitted. Upon resubmission of the acceptable plan of
correction, written notice shall be sent to the applicant acknowledging
same.
(5) The ASC shall come into
compliance at least 30 days prior to the expiration date of the
license.
(6) The department shall
verify the correction of deficiencies by mail or by an on-site
inspection.
(7) If the ASC does not
timely come into compliance, the department may take action in accordance with
§ 135.24 of this title (relating to Enforcement).
