CAP Sets New Requirements for Molecular Microbiology Waived Testing
The College of American Pathologists (CAP) has added four new requirements for waived molecular-based microbiology tests to the CAP point-of-care testing and limited service laboratory checklists The four requirements are summarized below:
- POC.08675 Quality Monitoring Statistics: calls for written procedures to monitor for the presence of false-positive results (owing to nucleic acid contamination, for example) for all molecular microbiology tests.
- POC.08690 Specimen Handling Procedures: calls for written procedures to prevent specimen loss, alteration, or contamination during collection, transport, processing, and storage. Collection, processing, and storage must follow the manufacturer’s instruction and limit the risk of pre-analytical error.
- POC.08715 Safe Specimen Handling/Processing: states there must be written policies for safely handling and processing samples from patients with suspected infection due to avian influenza, SARS, Ebola, or similar emerging pathogens
- POC.08730 Final Report: calls for the report to include a summary of the test method and information regarding clinical interpretation, if appropriate.