(a) In response to a complaint, the department or its authorized representative may enter the premises of an ambulatory surgical center (ASC) during normal business hours as necessary to assure compliance with the Act and these sections. The investigation may be conducted on-site, unannounced or announced, or may be investigated by phone or mail.
(b) All licensed ambulatory surgical centers are required to provide the patient and his/her guardian at time of admission a written statement identifying the department as the responsible agency for ambulatory surgical centers complaint investigations. The statement shall inform persons to direct complaint to the Department of State Health Services, Manager, Health Facility Compliance Group, Post Office Box 149347, Austin, Texas 78714-9347, (888) 973-0022. This information shall also be prominently and conspicuously posted for display in an area of the facility that is readily available to patients, families and visitors. Complaints may be registered with the department by phone or in writing. A complainant may provide his/her name, address, and phone number to the department. Anonymous complaints may be registered. All complaints are confidential.
(c) The department shall evaluate all complaints against all ambulatory surgical centers. Only those allegations determined to be relevant to the Act shall be authorized for investigation.
(d) Conduct of the investigation shall include, but is not limited to:
  (1) a conference prior to commencing the on-site inspection for the purpose of explaining the nature and scope of the inspection between the department's authorized representative and the person who is in charge of the ASC;
  (2) inspection of the ASC;
  (3) inspection of medical and personnel records, including administrative files, reports, records, or working papers;
  (4) an interview with any willing recipient of ambulatory surgical center services at the ASC or in the recipient's home if the recipient grants permission in writing;
  (5) an interview with any health care practitioner or ambulatory surgical center personnel who care for the recipient of ambulatory surgical services; and
  (6) a conference at the conclusion of the inspection between the department's representative and the person who is in charge of the ASC.
    (A) The department's representative shall identify any records that have been reproduced.
    (B) Any records that are removed from an ASC (other than those reproduced) shall be removed only with the consent of the ASC. The ASC shall furnish copies of all records pertinent to the investigation at the department's request.
(e) The department shall review the report of the investigation and determine the validity of the complaint.

Source Note: The provisions of this §135.25 adopted to be effective June 18, 2009, 34 TexReg 3948