A quality control specialist plays a crucial role in ensuring the accuracy and reliability of laboratory results. One key aspect of their work involves comparing the output of different testing procedures and laboratories. This process, often referred to as external quality assessment (EQA), is essential for maintaining high standards in diagnostic testing, particularly for rare and specialized assays. This article explores the importance of EQA, highlighting the Laboratory Quality Assurance for Rare Specialist Assays (LQARSA) scheme as a practical example.
The Importance of External Quality Assessment
EQA aims to harmonize results across laboratories and instruments, providing a benchmark for performance. By comparing results from different labs, quality control specialists can identify discrepancies and potential issues in testing procedures. This retrospective analysis helps pinpoint anomalies such as faulty instruments, reagent problems, or inconsistencies in quality control material preparation. Participating in EQA schemes ensures adherence to good laboratory practices and allows for continuous improvement in testing accuracy.
LQARSA: A Case Study in Quality Control for Rare Assays
Laboratories seeking accreditation under the International Standard ISO 15189:2012 must undergo rigorous assessments. While established EQA schemes exist for many common tests, rare specialist assays often lack such programs due to the limited number of laboratories performing them. LQARSA addresses this gap, providing a quality assurance framework for these specialized tests, often conducted in specialized centers linked to trauma or Haemophilia Centers. Examples include time-sensitive tests like platelet aggregation studies and Platelet Function Assays (PFA), which require processing within four hours of collection.
Table illustrating participating laboratories and tests included in the LQARSA scheme.
Implemented by Senior Biomedical Scientist Charlotte Noronha within Viapath’s Diagnostic Haemostasis & Thrombosis laboratories, LQARSA involves exchanging specimens previously tested at Viapath and other major specialist centers across the UK. This inter-laboratory comparison occurs at least twice yearly, contingent on sample availability and suitability.
Comparing Results and Resolving Discrepancies
A Quality Control Specialist Compares The Output from each participating laboratory. If discrepancies arise, scientific leads from both laboratories engage in discussions to determine the root cause and achieve a mutually agreeable resolution. A four-week timeframe is allotted for issue resolution, with ongoing investigations communicated if necessary. At Viapath, such decisions involve consultation with Consultant Biomedical Scientist Dr. Gary Moore, documented in quality control error logs and governance reports.
Collaboration and Innovation in Quality Improvement
The inaugural Innovation and Collaboration Meeting, held at St Thomas’ Hospital in 2017, brought together Viapath representatives and colleagues from other specialist hospitals. This forum facilitated the sharing of experiences regarding sample exchange, ISO non-conformances, and cross-site testing challenges. Discussions focused on improving sample transit times, crucial for time-sensitive assays, and implementing intra-laboratory quality assessments when cross-site exchange is impossible, such as through repeat sample analysis.
Future Directions for LQARSA
Expansion plans for LQARSA include incorporating additional rare specialist tests, such as ATP release measurement (Chronolog), Anti-factor VIII ELISA, and HIT-A. Furthermore, broadening participation to include more specialist centers is under consideration. The success of the initial meeting has led to the scheduling of future collaborative events.
Image showcasing the LQARSA team and their commitment to quality assurance.
Conclusion
A quality control specialist comparing the output from different laboratories plays a vital role in ensuring the accuracy and reliability of specialized medical testing. EQA schemes like LQARSA provide a critical framework for maintaining high standards in diagnostic testing, particularly for rare assays where traditional EQA programs may be lacking. Through collaboration, innovation, and continuous improvement, these programs contribute significantly to patient care and the advancement of laboratory medicine.
