Establishing a quality management system for unit-use testing based on NCCLS proposed guideline (EP18-P)

Point of care tests often employ unit-use test devices. By their very nature (single use, disposable, self-contained) such devices present unique challenges for quality assurance (QA) and quality control (QC). The proposed NCCLS guideline (EP18-P) recommends a quality management system for unit-use testing. The document addresses regulatory considerations, proposes the development of a partnership between users and manufacturers, provides a source of error matrix, and suggests practical approaches to quality monitoring, identification and management of these potential problems. The key to the success of this guideline is cooperation and open exchange of information among manufacturers, users, regulators, and accrediting agencies.