Regulation .06 Quality Assurance.
Regulation .06 Quality Assurance.LinkCopy Citation
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.