The College of American Pathologists (CAP) recognizes MALDI-TOF MS as a valid method to identify microorganisms. A list of mandatory requirements for compliance is in the latest CAP checklist for US Laboratory Accreditation. The CAP’s program was developed to help reinforce the International Organization for Standardization's (ISO) goals and standards while supporting CAP’s mission of advocating excellence in the practice of pathology and laboratory medicine. This is evident as CAP is also a significant contributor to the development of the ISO 15189 standard. In addition, the Clinical Laboratory Improvement Act (CLIA) and The Joint Commission (TJC) recognize and reciprocate CAP's role in accreditation.
A partial list from the CAP checklist includes:
- Running a calibration control with each run of testing and with each change in target plate, according to the manufacturer’s recommendations. These data are recorded and maintained by the laboratory.
- Running appropriate control microorganisms daily to include at least one bacterium, a representative yeast, other microorganisms (Mycobacterium, Nocardia) if included in the run (subjected to the same extraction procedures as tested isolates), and blank control. Records are maintained.
- Reagents and solvents to be of appropriate grade (HPLC grade or other). Safety data sheets (SDSs) are maintained with reagent logs.
- Consumables are the appropriate manufacturing type to function as required.
