The quality management system approach applies a core set of quality system essentials to all operations in any healthcare service’s workflow path. POCT has multiple QA issues and, due to the rapid availability of results, POCT data can be seen and acted upon prior to the application of QC checks or other external mechanisms for assuring the validity of test results. Most errors in laboratory testing are pre-analytical in nature, followed by post-analytical, with only 15% occurring during the analytical phase. However, even though POCT has seen an overall reduction in errors, most occur during the analytical phase. POCT technology has evolved to a level of intelligent automation that detects single point failures and automatically stops the analytical process. Nevertheless, QC procedures are an essential part of the quality management system and must be able to detect mistakes to enable immediate correction. Surrogate and non-surrogate QC are not completely redundant and do not detect all assay errors. It is necessary that the sources of error in the POCT analytical process be identified and an individualized quality control plan be developed that mitigates the risks of error to acceptable levels.
- Discuss what a quality management system is and what quality system essentials are.
- Describe the influence of POCT on the probability of occurrence of pre-analytical, analytical, and post-analytical errors.
- Assess the nature of QC procedures and describe the differences between surrogate and non-surrogate quality control.
- Explain the critical factors to consider when deciding the appropriate POCT QC system to implement.
This basic-level, complimentary webinar is produced by Whitehat Communications. Whitehat Communications is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program.