The New and Enhanced IQC & EQA Requirements of ISO 15189:2022: A HuQAS Perspective.

Background

Since its first publication in 2003, ISO 15189 standard has been evolving, through successful periodic reviews, resulting in three other editions. These are the versions published in 2007, 2012 and recently 2022. Among several clauses affected by changes in the current edition is one on, ensuring quality of examination results. This position paper provides an in-depth understanding of key changes under this clause particularly on the requirements for Internal Quality Control & External Quality Assessment including a justification for our view.
 

Method 

A communique was released by ILAC and KENAS in December 2022, regarding the release of ISO 15189:2022. Since then, HuQAS has been involved in various stakeholder forums to discuss new changes in the standard. For instance, inhouse brainstorming sessions were held in March 2023, to assist staff recognize the changes and how they affected HuQAS operations as a proficiency testing provider, continuous professional development (CPD) training provider and an implementing partner for ISO 15189 laboratory accreditation. In July 2023, the new IQC and EQA requirements were discussed in a workshop held in Dar es Salaam themed, Navigating Quality Management in Medical Laboratories: Process Control and Effective Utilization of HuQAS EQA. Participants expressed
their views on these requirements. It is against this backdrop that we compiled our position on clause 7.3.7.2 Internal quality control (IQC) and 7.3.7.3 External quality assessment (EQA).

Results

Upon realization that promotion of patient’s well-being and satisfaction of laboratory users are the primary consideration, we strongly support the new and enhanced requirements of clause 7.3.7.3 and 7.3.7.3 and justify as follows: First, unlike requirements of the previous versions of ISO 15189, the IQC and EQA programmes will now also be implemented for point of care examination methods.
Secondly, the use of third-party IQC materials should be now considered, either as an alternative to, or in addition to, control material supplied by the reagent or instrument manufacturer. Thirdly, it is now a mandatory requirement that concentration of quality control materials covers the entire measurement range of examination methods so that they offer a clinically relevant challenge to those methods. Fourthly, use of applicable statistical techniques such as Levey Jenning charts and Westgard rules to detect trends and shifts is now a mandatory requirement. Fifthly, laboratories selection and enrolment to EQA programme(s) that meet requirements of ISO 17043 is also a mandatory requirement in the new standard. Finally, there is increased emphasis on impact assessment on the patient whenever IQC and EQA results fall outside of acceptability criteria.

Conclusion

It is therefore our strong view that ISO 15189:2022 is focussed on improving patient outcomes in the laboratory. With the new and enhanced changes in IQC and EQA requirements, reliability of laboratory test results is assured.