Accreditation agencies are increasingly requiring laboratories to go beyond the analytical quality and take responsibility for the extra-analytical phases. The Joint Commission International defines international patient safety goals with the objective of improving patient identification, and communication among caregivers; the College of American Physicians (CAP) requires that laboratories monitor certain quality indicators (QI) that deal with extra-analytical phases.
“We should be challenging laboratories in the pre- and post- examination phases… because that’s where the errors are.”
Dr. M. Noble
ISO15819 “Medical laboratories – Particular requirements for quality and competence” states that “EQA programs should, as far as possible, provide clinically relevant challenges that mimic patient samples and have the effect of checking the entire examination process, including pre- and post-examination procedures.”
However, providing EQA programs for the extra-analytical phases has many challenges. Most EQA providers lack the tools for it as evaluating the extra-analytical phase involves targeting different locations and staff groups, many of them outside the laboratory’s control.
In a fairly recent publication, Kristensen from the Norwegian EQA program (NKK) describes three different approaches that are currently used to test the extra-analytical phases.
Type I EQA schemes – Registration of procedures – they seek to challenge laboratories through questionnaires, registration of procedures, and evaluation of reports. A scenario is usually presented and laboratories are asked to report how they would handle certain situations. This type of scheme has the advantage of needing limited resources, it can address several aspects of the TTP, and as it can be available online, it can have a very broad reach. This approach requires the questionnaires to be validated by experts.
Type II EQA schemes – Circulation of samples with errors – similarly to regular proficiency testing schemes samples are produced and circulated with specific errors (labeling, interfering substances, etc.) and the laboratories are evaluated on the way they handle these samples. This approach requires expertise in preparing the samples, and can introduce bias, if the laboratory is expecting to receive samples with some kind of issue.
Type III EQA schemes – Registration of errors/adverse events – they use the laboratory’s error reporting system to register errors/events for a particular QI over a period of time. At the end of that period, the laboratories receive feedback and comparison with all participants. This type of scheme requires harmonized QI to be able to compare among different laboratories.
Type IV Reverse PT: where the PT provider asks for samples “produced” by the participant laboratory (e.g. CMPT has asked for an isolated to be sent back to evaluate the packaging practices)
Table 1 shows examples of EQA programs using these different types of EQA schemes.
|Type I||ECAT (Netherlands)
|Type II||WEQAS (UK)
|Type III||CAP (US)
KIMMS QA (Australasia)
|Type IV||CMPT (Canada)|