External Quality Assessment beyond the analytical phase: an Australian perspective

Abstract

External Quality Assessment (EQA) is the verification, on a recurring basis, that laboratory results conform to expectations for the quality required for patient care. It is now widely recognised that both the pre- and post-laboratory phase of testing, termed the diagnostic phases, are a significant source of laboratory errors. These errors have a direct impact on both the effectiveness of the laboratory and patient safety. Despite this, Australian laboratories tend to be focussed on very narrow concepts of EQA, primarily surrounding test accuracy, with little in the way of EQA programs for the diagnostic phases. There is a wide range of possibilities for the development of EQA for the diagnostic phases in Australia, such as the utilisation of scenarios and health informatics. Such programs can also be supported through advances in health information and communications technology, including electronic test ordering and clinical decision support systems. While the development of such programs will require consultation and support from the referring doctors, and their format will need careful construction to ensure that the data collected is de-identified and provides education as well as useful and informative data, we believe that there is high value in the development of such programs. Therefore, it is our opinion that all pathology laboratories should strive to be involved in an EQA program in the diagnostic phases to both monitor the diagnostic process and to identify, learn from and reduce errors and near misses in these phases in a timely fashion.

Quality Management Systems for Laboratories and External Quality Assurance Programs

“…Furthermore, the requesting and reporting diagnostic phases should also be covered by EQA programs due to two main reasons: high rate of errors associated and the definition of quality Quality Control in Laboratory management system (QMS) mentioned at the beginning of this chapter of fulfillment user requirements and satisfaction [24]. The design of such programs should be developed carefully to obtain useful information.…”

Opinion: redefining the role of the physician in laboratory medicine in the context of emerging technologies, personalised medicine and patient autonomy (‘4P medicine’)

“…These improvements enable clinical pathologists to spend less time with analytical processes and assign most of their time to being a partner to treating physicians (and to patients) for selecting and interpreting laboratory tests and advising on appropriate therapies. Extensive practical and theoretical medical expertise is essential for these tasks, which is reflected in recent modifications to the curricula for clinical pathology in different European countries, with a special focus on medical knowledge and practical experience, in particular in Internal Medicine and laboratory management skills rather than on analytical techniques 33…”

A 3‐year‐long investigation of the authenticity of the return results of hepatitis B virus qualitative testing in external quality assessment in East China

“…In the development of EQA schemes, the attention is usually paid to the quality of the samples, the consistency of laboratory test results, the commutability, and traceability in EQA programs, the pre and postlaboratory phase of testing, and the harmonization in laboratory medicine . These efforts do not only play an important role in the development of EQA but are very important for laboratories to get the best value from the EQA scheme in terms of validating methods and test results.…”