(a) Quality assurance includes the selection of professional personnel prior to engagement for service, ongoing review of clinical responsibilities and authority, and peer review and supervision of all professional and technical activities of personnel.
(b) The professional and administrative staff shall understand, support, and participate in the quality assurance program.
(c) The quality assurance program shall address clinical, administrative, and cost effective issues. Exclusive concentration on administrative cost effective issues does not fulfill this requirement.
(d) Quality assurance activities shall be conducted by the quality assurance committee, which is composed of specific clinical disciplines within the ambulatory surgical center (ASC) (individual medical specialties, nursing, etc.), and shall be consistent with the characteristics of the overall quality assurance program and the services provided by the ASC.
(e) Problem identification and resolution activities shall be conducted as part of an ongoing, organized quality assurance program in which all practitioners in all clinical disciplines have an opportunity to participate. A variety of self-assessment methodologies may be used to implement the quality assurance program. Assessment techniques shall examine the structure, process, or outcome of care, and shall be assessed prospectively, concurrently, or retrospectively.
(f) Quality assurance activities shall address the following.
  (1) Important problems or concerns in the care of patients shall be identified. Although the medical record is an important data source for identifying previously unrecognized problems, any sources may be used. Problems concerning accessibility, medical-legal issues, and wasteful practices shall be considered, as well as concerns previously recognized by patients and staff but inadequately addressed.
  (2) The frequency, severity, and source of suspected problems or concerns shall be assessed.
    (A) Health care practitioners shall participate in the development and application of the criteria used to evaluate the care they provide.
    (B) Health care practitioners shall participate in the evaluation of the problems or concerns identified.
    (C) A record shall be maintained of all fires, patient deaths, and all transfers from the ASC to the hospital.
  (3) Measures shall be implemented to resolve important problems or concerns that have been identified. Health care practitioners as well as administrative staff shall participate in the resolution of the problems or concerns that are identified.
  (4) The problems or concerns shall be reassessed to determine objectively whether or not the measures have achieved and sustained the desired result, and if not, why not.
  (5) Through the ASC's designated mechanisms, quality assurance activities shall be reported, as appropriate, to the proper personnel and the governing body.
(g) Quality assurance activities described in subsection (f) of this section shall encompass, but are not limited to:
  (1) the clinical performance of health care practitioners;
  (2) the standards for medical records;
  (3) quality controls for and the use of radiology, pathology, and medical laboratory services;
  (4) other professional and technical services provided; and
  (5) studies of patient satisfaction.
(h) The quality assurance program shall be a well-defined organized program designed to enhance patient care through the ongoing objective assessment of important aspects of patient care and the associated or identified problems. The responsibilities for quality assurance activities shall be clearly delineated.
  (1) Qualified medical staff shall participate in assessment of medical services by health care practitioners and shall be accomplished by a specified member(s) of the medical staff or by staff as a group.
  (2) Nursing service shall be represented by one or more qualified registered nurses in quality assurance activities.

Source Note: The provisions of this §135.8 adopted to be effective June 18, 2009, 34 TexReg 3948