.08 Quality Assurance Program.

A. The administrator shall ensure that the facility develops and maintains a quality assurance program which includes:

(1) Monitoring and evaluation of the quality of patient care;

(2) Identification, evaluation, and resolution of care problems; and

(3) A peer review process.

B. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly.

C. Peer Review. The administrator shall ensure that the facility establishes a peer review process that includes:

(1) A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually;

(2) Procedures, approved by a qualified health care practitioner to identify and minimize risks to the patient; and

(3) Documentation of each health care practitioner's annual evaluation.

D. Practitioner Performance Evaluation in a Facility.

(1) The administrator shall ensure that the facility establishes a practitioner performance evaluation process that includes a review of care which shall:

(a) Be undertaken for cases chosen at random and for cases with unexpected adverse outcomes;

(b) Be based on objective review standards;

(c) Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patientís condition; and

(d) Be conducted by at least two members of the medical staff who:

(i) As appropriate, are of the same specialty as the member of the medical staff under review; and

(ii) Have been trained in the freestanding ambulatory care facilityís policies and procedures regarding practitioner performance evaluation.

(2) A review of the care provided by a member of the medical staff who is a solo practitioner shall be conducted by an external reviewer.

(3) A freestanding ambulatory care facility shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process.

E. Equipment Quality Control.

(1) The administrator shall ensure that the facility develops a quality control procedure to monitor the safety and performance of all biomedical equipment.

(2) In developing its procedures, the administrator shall consider:

(a) FDA recommendations; and

(b) The equipment manufacturer's recommendations.

F. Documentation.

(1) At the time of application, the applicant shall submit a written description of the facility's quality assurance program which includes, at a minimum:

(a) A description of how the facility will comply with §A of this regulation; and

(b) The manner in which information will be collected.

(2) The facility shall submit any revisions to its quality assurance program at the time of licensure renewal.

G. Quality Assurance Records. The facility shall document the following information for all quality assurance activities:

(1) A description of identified problems;

(2) Findings;

(3) Conclusions;

(4) Recommendations;

(5) Actions taken;

(6) Results; and

(7) Follow-up.