Sprinkled throughout the CLIA regulation are requirements for policies and procedures. All policies and procedures must be approved, signed, and dated by the laboratory director when they are implemented and whenever any changes are made. It’s important to note each policy and procedure must be individually signed by the laboratory director. The laboratory director cannot approve a policy or procedure by signing a cover sheet in the procedure manual. Policies and procedures must also contain the date the policy / procedure is implemented and if discontinued, the date discontinued. Discontinued policies / procedures must be retained for a minimum of two years after the date of discontinuance.
Policies and procedures required by CLIA include:
- A system for the positive identification of a blood or blood product recipient
- Preventing transfusion reactions
- Investigation of transfusion reactions
- Positive identification and optimum integrity of patient specimens through the entire testing process (including sample collection and result reporting)
- Employee and consultant competency
- Patient preparation
- Specimen collection
- Specimen labelling
- Specimen storage and preservation
- Conditions for specimen transport
- Specimen processing
- Specimen acceptability and rejection criteria
- Specimen referral
- Step by step performance of each test performed (including any calculations, microscopic examination, and interpretation of results)
- Preparation of materials used in testing (including reagents, slides, stains, etc.)
- Calibration and calibration verification activities
- Reportable ranges for each analyte
- Quality control
- Corrective action
- Limitation in test methodology
- Normal values (reference intervals)
- Panic or alert values
- System for entering test results into patient medical records
- What to do if a system becomes inoperable
- Storage of reagents and specimens
- Quality Assurance
- Employee Training and competency
Laboratories are required to have many policies and procedures and each policy / procedure must reflect current laboratory practices. ProLab Consulting, LLC can provide laboratories with current policies and procedures. Let us perform the work and you take care of the patients!
Procedure Manual Assistance
After ProLab Consulting, LLC has performed an initial assessment of the laboratory’s policy / procedure manual(s) for compliance with CLIA regulations, and provided our client with a “Report of Laboratory Assessment”, the laboratory director may recognize a need for assistance with establishing and / or revising policies and procedures to meet applicable CLIA regulations.
ProLab Consulting LLC offers “Procedure Manual Assistance” to help the laboratory establish or revise policies and procedures to meet applicable CLIA regulations. Any policies / procedures (or required elements of a policy / procedure) which are missing are created and provided to the laboratory either electronically or in the form of a hard copy (may be subject to additional printing fee). Once the laboratory has received their new or revised policies and procedures.
ProLab Consulting, LLC is not responsible for any revision of policies / procedures made by the laboratory without the knowledge, consultation, and approval of ProLab Consulting, LLC.
This service is offered as a one-time service per manual.