The College of American Pathologists (CAP) requires a document control system in a laboratory as a standard for certification.
Elements of an adequate document control system:
(1) The documents must be current (reflecting actual practices).
(2) There is evidence that each employee is familiar with the documents appropriate to his or her job duties.
(3) The document must be properly authorized prior to being placed into service for the first time.
(4) The document must be reviewed at least annually (once each calendar year).
(5) A discontinued document must be retained for the specified period of time at a minimum (5 years for Blood Bank, 2 years for all laboratory sections).
In addition, a complete procedure manual must be available at the workbench.
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