An organized, written plan is developed, implemented, and shared with the staff to guarantee that all laboratory and laboratory testing aspects are evaluated in the quality assessment plan.
The laboratory director oversees the quality assessment plan and can delegate any or all responsibilities in writing.
Reviews are completed on a regular schedule. The schedule is published in the quality assessment plan for easy organizing and tracking review completion. An annual calendar is not required for compliance but represents an acceptable organizational tool to guide 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, document review and revision, staff retraining, and further review and research of the 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.
Pre-examination
- Patient preparation, specimen collection, transport, specimen quality
- Specimen Integrity
- Requisitions
- Communication
Examination
- Quality control review
- Calibration and calibration verification
- Instrument performance and maintenance
- Proficiency testing
- Personnel records, training records, competency assessment
Post-examination
- Test reports
- Distribution of results
- Critical Values
- Turn around times
