Every POCT program must have a comprehensive QA plan in place with corrective actions for monitors that are found to be unsatisfactory. An appropriate QA program will include periodic monitors of all of the following:
- Personnel records, to include verification of qualifications with a diploma or transcript, initial training records for all testing methods performed, and competency assessment at the time of hire, 6 months post-hire, 1-year post-hire, and annually after that, as required by the complexity of method for compliance and accreditation. Records should also include OSHA training and verification of hepatitis B vaccination or declination. The annual review of these records should be part of the QA plan.
- QC records and environmental conditions, such as temperature, humidity, and centrifuge cleaning, should be reviewed at least monthly.
- Review and corrective action if the test method, state, or accrediting agency requires proficiency testing (PT). This review should be conducted after each event has been completed.
- Tracking of testing performed.
- Annual or biennial policy review by appropriate personnel, as required for compliance and accreditation.
- Review and determine the completion of corrective action for incident reports and affected patients.
- Periodic review of communications between staff members and administration.
- Periodic review of sample collection, labeling, and documentation.
The integration of the laboratory staff into the quality assessment plan for the POCT system expands from the laboratory operation to the bedside. It continues to incorporate the laboratory staff directly into the patient-centered care approach.
