Authors consider non-compliance rate "very acceptable"
by Dennis Ernst • August 11, 2021
I'm really scratching my head here.
Recently, a survey of European laboratories showed inconsistencies in the practice of recording the time and date blood samples are collected. In fact, over half of the reporting labs participating in the survey admitted that recoding the time and date of collection occurs only some of the time. Yet the authors of the study concluded that overall, compliance with this requirement of every standards organization (CLSI, WHO, & ISO) is "very acceptable."
The study, published in the Journal of Clinical Chemistry and Laboratory Medicine, is titled "Exact time of venous blood sample collection – an unresolved issue, on behalf of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase." Giuseppe Lippi, one of the authors of the study, also edits the publication. If nothing else, faithful followers of my blog and prior newsletters know these three things about scientific journals:
- they must be read critically;
- the conclusions authors draw are not always logical;
- even flawed research and illogical conclusions get published.
Given the importance of preanalytical variables (including the time and date of collection) on accurate test results, what I'm scratching my head about are these four questions:
- How is it acceptable when up to 64% of ISO-accredited labs are out of compliance with the requirement to document the time and date of collection?
- How is the lab or physician to know if the sample wasn't pulled out of the refrigerator where it's been stored since last week?
- How is the patient well-served when the sample may reflect his/her health status from last week, not today?
- How can a physician possibly monitor a drug's effectiveness when there's no indication how long after the last does the blood sample was drawn?
So, yeah, I'm a little gob-smacked here. It seems to me finding such a low compliance rate to be "very acceptable" is striving for mediocrity and falling short. To be fair, I'm not picking on European healthcare. Make no mistake, I've been to hospitals and laboratories in the European Union and was very impressed with what I saw. To my knowledge, a similar study of compliance in the U.S. has not been undertaken. It could be just as pathetic on this side of the pond. I have my doubts, though. Even if documentation here was similarly dysfunctional, I can't imagine it being proclaimed even marginally acceptable.
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