.06 Quality Assurance.

A. The facility shall plan and implement 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 facility shall establish 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 supervising physician, to identify and minimize risks to the patient; and

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

D. Equipment Quality Control.

(1) The facility shall develop and implement a quality control procedure to monitor the safety and performance of all biomedical equipment.

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

(a) FDA recommendations; and

(b) The equipment manufacturer's recommendations.

E. 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.