Practical considerations on redesigning internal quality control process to verify the traceability of clinical results for decision-making

TL;DR

This paper discusses the challenges of applying traceability standards to internal quality control materials in medical labs under the 2022 ISO 15189 requirements.

Contribution

The paper highlights practical implementation issues and limitations in using traceable IQC materials for trueness verification.

Findings

There are operational hurdles in acquiring traceable IQC materials.

Manufacturers and labs face limitations in applying traceability standards.

Recommendations require consideration of practical constraints for routine use.

Abstract

Traceability is an important tool in the harmonization and standardization of reporting laboratory results, making them comparable across measurement systems. Driven by International Standardization Organization (ISO) 15189 accreditation requirements, medical laboratories have entered the era of metrological traceability. Although calibrators are a key component in the entire metrological traceability system, there is controversy over internal quality control (IQC) materials. It has been proposed that trueness materials supplied by the system's manufacturer with metrological traceability can be used to confirm that the performance of the measuring system is properly unbiased. This article focuses on the implementation challenges and operational hurdles of applying traceability concepts to IQC materials for trueness verification in medical laboratories regarding the most recent 2022 edition of ISO 15189 standard requirements for IQC and metrological traceability. There are practical considerations concerning the acquiring of IQC materials. We must acknowledge the limitations and restrictions that manufacturers and laboratories face before the recommendations can be applied in routine practices.

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