Individualized quality control plan and its impact on quality management of clinical laboratories

doi:10.3877/cma.j.issn.2095-5820.2016.04.004

Abstract

Abstract:

The Clinical Laboratory Improvement Amendments (CLIA) individualized quality control plan (IQCP) is a risk-based, objective approach to performing quality control testing. It is based on assessment of the unique laboratory testing in use, patient populations and other aspects (for example, internal quality checks built into new instruments). IQCP is the implemented under the Centers for Medicare & Medicaid Services (CMS) regulation 42 CFR 493.1256 Standard: Control Procedures, and apply to most CMS-certified current and new non-waived tests. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process.

In this article, we introduce the concept of IQCP and discuss the overall situation of IQCP implementation so far. Hopefully, this new idea of quality plan could provide clues on how to improve quality management based on each clinical lab′s specific situation in China.

Key words: Individualized quality control plan, Clinical laboratory, Risk assessment, Quality management

Haixia Huang, Ziyu Shen. Individualized quality control plan and its impact on quality management of clinical laboratories[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2016, 04(04): 205-212.

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References 30

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