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RULE §135.21Inspections

(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).

Source Note: The provisions of this §135.21 adopted to be effective June 18, 2009, 34 TexReg 3948

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