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Establishing a quality management system for unit-use testing based on NCCLS proposed guideline (EP18-P)
R J Whitley1, P J Santrach, D L Phillips
1Department of Pathology, University of Kentucky, Lexington, KY 40536, USA. rjwhit00@pop.uky.edu
Summary
Quality assurance for single-use point-of-care tests is challenging. A proposed guideline (EP18-P) recommends a quality management system, emphasizing collaboration between users and manufacturers for effective quality control.
Area of Science:
- Clinical diagnostics
- Medical device quality assurance
Background:
- Unit-use test devices are common in point-of-care testing.
- These disposable, self-contained devices present unique quality assurance (QA) and quality control (QC) challenges.
Purpose of the Study:
- To propose a quality management system guideline (EP18-P) for unit-use testing devices.
- To address regulatory considerations and foster user-manufacturer partnerships.
Main Methods:
- The guideline suggests developing a partnership between users and manufacturers.
- It provides an error matrix and practical approaches for quality monitoring.
- It focuses on identifying and managing potential problems in unit-use testing.
Main Results:
- The guideline offers a framework for quality management in point-of-care testing.
- It outlines strategies for error detection and problem resolution.
Conclusions:
- Successful implementation relies on cooperation and open information exchange among all stakeholders.
- Effective QA/QC for unit-use devices requires a collaborative approach.