§ 493.1703 - Standard; Patient test management assessment.

The laboratory must have an ongoing mechanism for monitoring and evaluating the systems required under subpart J, Patient Test Management. The laboratory must monitor, evaluate, and revise, if necessary, based on the results of its evaluations, the following:

(a) The criteria established for patient preparation, specimen collection, labeling, preservation and transportation;

(b) The information solicited and obtained on the laboratory's test requisition for its completeness, relevance, and necessity for the testing of patient specimens;

(c) The use and appropriateness of the criteria established for specimen rejection;

(d) The completeness, usefulness, and accuracy of the test report information necessary for the interpretation or utilization of test results;

(e) The timely reporting of test results based on testing priorities (STAT, routine, etc.); and

(f) The accuracy and reliability of test reporting systems, appropriate storage of records and retrieval of test results.