CLIA Requirements for Procedure Manuals Laboratory Operations Review 61
A written procedure manual must be available to testing
personnel & must include:
- Requirements for patient preparation, specimen
collection, labeling, storage, preservation, transporta-
tion, processing, referral & criteria for specimen ac-
ceptability & rejection - Procedures for microscopic examinations, including
detection of inadequately prepared slides - Step-by-step performance of the procedure, including
test calculations & interpretation of results - Preparation of slides, solutions, calibrators, controls,
reagents, stains, & other materials used in testing - Calibration & calibration verification procedures
- Reportable range for patient test results
- Control procedures
- Corrective action when calibration or control results
fail to meet lab’s criteria for acceptability - Limitations in methodology, including interfering
substances
10. Reference intervals
11. Imminently life-threatening laboratory results (critical
values)
12. Pertinent literature references
13. System for entering results in patient record & report-
ing (including protocol for critical values)
14. Action to take if test system becomes inoperable
Manufacturer’s instructions may be used for #1–12. Procedures & changes must be approved, signed, & dated by director before use.
Copies of procedures must be retained for 2 yr after discontinuance & must include dates of initial use & discontinuance.