ABSTRACT

There should be an established program that monitors and evalu­ ates all laboratory procedures and the competence of the laboratory staff. The program should be well-documented and provide the aud­ itor with evidence that the. laboratory is effective in the following areas:

1. Accuracy of test data 2. Timely reporting of test data 3. Action plans to correct problems 4. Proficiency testing 5. Adequate training of analysts

There must be an approved written procedure for each step in the handling, storage, preparation, and testing of a sample (or speci­ men). The review of all procedures at least annually is part of the quality program.