Zeh et al. have published an uncommon paper showing that ISO 15189 is wonderful – just as the cartel tells its victims.
“In summary, accreditation benefits are numerous, including reduction in costs, ease in management and process control, increased quality service delivery and client satisfaction, and enhanced staff competency.”
No buyer’s remorse then.
Unusually, the authors provide some metrics of the improvements. These mirror the accreditors’ claims.
Preaccreditation and postaccreditation external audit findings by South Africa National Accreditation System (SANAS) and Pharmaceutical Product Development (PPD). Accreditation occurred in March 2008. Major nonconformances (NCs) are deviations from the standard indicative of a total breakdown in the system or one that would significantly affect the patients’ results, whereas minor NCs are those that are indicative of partial breakdown in the system.
How surprising is that before working to an ISO standard many items do not comply with it? The before/after comparison is tautological. It is invalid because it is self-fulfilling.
Accreditation guarantees bumph for inspection, and compliance. Improvements in genuine quality may sometimes follow, especially if things were bad before.
As for cost saving, how correct is it to include that $60,000 in the top line as a cost of delivering the service pre-accreditation? The cost arises directly from preparation for accreditation and would not have been incurred without it. This cost should be shifted to the post-accreditation column where it shows that the cost of the first year after accreditation was approximately double the cost before. This seems not to be a recurring figure, but the cost after accreditation remains high and the completeness of the figures is plainly incomplete. No account is taken of the additional staff time spend on administering the inspection system. The authors acknowledge some of the other costs that were not included in this table.
Figure 3. Trends in the number of complaints from January 2006 (preaccreditation) to January 2009 (postaccreditation). Accreditation occurred in March 2008.
High complaints fell as the lab moved towards accreditation. No improvement occurred after accreditation because the level is so low. This indicates the improvement that can be achieved when a poor lab is properly resourced and organised. To know if it was uniquely due to accreditation cannot be said from this report. It was not designed to show whether resources, organisation, accreditation, broken telephones, dishonest postmen or some other factors caused the reduction in complaints.
How did this manuscript pass peer-review? Let’s hope readers don’t accept such papers at face value. It is largely descriptive and provides little real evidence that accreditation is solely responsible for the improvements.