Why Do We Send Paper Challenges?

The recently reviewed ISO 18159:2022 standard (Medical laboratories – Requirements for quality and competence) indicates that testing laboratories should participate in EQA programmes and that those EQA programmes should, to the extent possible, check the pre-examination, examination, and post-examination procedures.

Ideally, EQA programmes should be designed so they can provide insight into the complete path of workflow of the laboratory and promote quality improvement by providing education to participants.

How does an EQA programme provide insight into the complete testing cycle?

Research shows that 80-94% of the errors occur in the extra analytical phase however, most PT programs focus on the analytical phase therefore, only targeting 6-20% of laboratory errors.

The tools to evaluate the areas outside the analytical phase can be seen in figure 1 and have also been reviewed previously in this newsletter.

Paper challenges address issues that are not as standardized as analytical procedures.

In 1998-1999 CMPT introduced the paper challenge (PC) format with the aim of extending the arena of laboratory challenges further into the pre-analytic, early phase of laboratory testing because as CMPT’s founder Dr. M. Noble would say “We should be challenging 
laboratories in the Pre and Post Examination Phases… because that’s where the errors are.”

In a recent review of the PCs sent from 2018 to 2023, out of 16 challenges 7 (44%) were not suitable for grading because of lack on consensus among reference laboratories or participants, or both. In addition, a customer satisfaction survey sent in March 2023 revealed that 12% of those who submitted a response found the PC challenges very valuable, 44% found them valuable, 33% were indifferent and 8% considered them not very valuable.

So, with a low percentage of graded challenges, and a questionable popularity, why bother? Exactly because of that.

Paper challenges address issues that are not as standardized as analytical procedures; every lab has specific ways to address privacy issues, safety issues, shipping of dangerous goods issues, etc. Some of them, although different, correct … some not. This is revealed in the heterogeneity of answers submitted which makes the PC not suitable for grading, but in no way, makes it irrelevant of not suitable for education.

No PT sample can reveal these gaps in the laboratory process, but laboratory staff should remember, that every single step of the process contributes to providing the best results possible for the benefit of the patient.

The lack of popularity of the PCs may be related to the frustration of having to answer questions unrelated to the laboratory bench. But PT should not be restricted to laboratory technologists and should involve all levels and all positions that are involved in the processing, testing, and reporting of results.

Laboratories should use the PCs as an educational tool, what EQA ultimately is: an opportunity to reveal weaknesses in the system so they can be addressed and thus, make the process better and safer.

Figure 1 Laboratory total testing process. The figure lists the common laboratory errors for each testing phase, areas for EQA assessment and what EQA tools are used to evaluate each step.

Posted in Quality