To guarantee that all aspects of the laboratory and laboratory testing are evaluated in the quality assessment plan, an organized, written plan is developed, implemented, and shared with the staff.
The laboratory director is responsible for overseeing the quality assessment plan. The director can delegate in writing any or all responsibilities.
Reviews are completed on a regular schedule. The schedule is published in the quality assessment plan for ease of organizing and tracking the completion of reviews. An annual calendar is not required for compliance but represents an acceptable organizational tool to provide guidance for regular review of all systems.
The steps to be completed when performing a quality assessment review are:
- Access appropriate documents, forms, data, and other tools, etc, as appropriate for review
- View the documentation as required in the tool provided
- Document review in the manner required in the quality assessment plan. Document items included and those that may have been omitted.
- Submit/review the findings with the appropriate personnel.
- Perform corrective action that may include repeat testing, review and revision of documents, retraining staff, and further review and research of documents present.
- Perform any follow-up required as per a published schedule in the corrective action plan.
Below is a summary of topics that may be included in the quality assessment plan and individual reviews.
Preanalytical
- Patient preparation, specimen collection, transport, specimen quality
- Specimen Integrity
- Requisitions
- Communication
Analytical
- Quality control review
- Calibration and calibration verification
- Instrument performance and maintenance
- Proficiency testing
- Personnel records, training records, competency assessment
Post Analytical
- Test reports
- Distribution of results
- Critical Values
- Turn around times
