Why Policies and Procedures Matter Under CLIA
Policies and procedures translate CLIA regulations into daily practice. CLIA surveyors routinely review procedure manuals to confirm that your written processes match what staff actually do.
What CLIA Expects in Procedure Manuals
For each test system, your procedure manual should include:
- Purpose and clinical use of the test.
- Specimen requirements, collection, labeling, and handling.
- Reagents, supplies, and required equipment.
- Step-by-step instructions for performing the test.
- Quality control requirements and acceptable ranges.
- Calculation and interpretation of results.
- Critical values and reporting requirements.
- Troubleshooting and limitations of the method.
Policy Requirements Beyond Test Procedures
Labs must also maintain policies covering:
- Specimen rejection criteria.
- Result reporting, corrections, and amended reports.
- Proficiency testing handling and review.
- Safety, infection control, and waste disposal.
- Incident reporting and corrective actions.
Review and Approval Expectations
CLIA requires that procedures:
- Are approved, signed, and dated by the laboratory director or designee.
- Are reviewed at defined intervals (commonly annually) and updated as needed.
- Are readily accessible to the staff performing the testing.
How mylabcompliance.io Simplifies Policy Management
mylabcompliance.io enables digital policy and procedure management:
- Upload or create procedures with version control and approval workflows.
- Assign review schedules and track completion.
- Give staff online access to the latest approved version.
- Build audit trails showing who reviewed and acknowledged each procedure.