New Laboratory Equipment Performance Qualification Document

Clinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance provides recommendations for conducting the initial performance qualification as well as the ongoing verification and preventive maintenance of general laboratory equipment. This is essential to ensuring the achievement of accurate and reproducible examination results. This guideline specifies recommendations for conducting performance qualification (PQ), routine function checks, calibration verification, and preventive maintenance of 20 types of general laboratory equipment. Most examination results reported by laboratories are generated by methods that use common general laboratory equipment. PQ is the process by which the laboratory confirms that the equipment performs as expected and meets the laboratory’s specific needs before use for examinations. Appendix A1 of QMS 23 provides information to include in a PQ protocol. In addition, Appendix A2 provides a laboratory equipment PQ checklist, and Appendix A3 includes a sample equipment PQ form.

Kathleen A. Grindle, MT(ASCP), CQA(ASQ)CPGP, Vice-Chairholder of QMS23, said, “Each equipment section in the guidance has the same organizational structure for ease of use but is specific for a particular piece of equipment. Essentially, a lab can take a specific section and associated appendixes and create an installation to retirement protocol for that piece of equipment.”