General Laboratory Equipment Performance Qualification
Written by: Kathleen A. Grindle, MT(ASCP), CQA(ASQ)CPGP
Most examination results reported by laboratories are generated by methods that use common general laboratory equipment. Understanding what is needed to begin using and then maintaining the equipment can often be challenging.
Clinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance is designed as a toolkit for general laboratory equipment. It provides recommendations for conducting the initial performance qualification as well as the ongoing verification and preventive maintenance of general laboratory equipment that is essential in ensuring the achievement of accurate and reproducible examination results.
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.
This guideline specifies recommendations for conducting performance qualification (PQ), routine function checks, calibration verification, and preventive maintenance (PM) of 20 types of general laboratory equipment (eg, centrifuge, fume hood, pipette), as well as a quality assurance program for equipment that evaluates performance and stresses PM. These activities keep the equipment in optimal operating condition, prevent problems from occurring, and help to identify early indicators (eg, function check and calibration failures) that suggest the equipment is not working properly and may need service.
The suggested activities follow the equipment’s lifespan and some important equipment-specific considerations for selection, installation, and safety.
Clinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance is an invaluable resource for laboratories both acquiring new equipment as well as those those looking for guidance in maintaining current equipment.