Why We Must

While I have been feverishly writing what seems to be the miniature book called a doctorate thesis research proposal, I came across some curious statistics in the literature that I thought my readership would be interested in.

From a study reviewing malpractice claims: “The most common breakdowns in the diagnostic process were failure to order an appropriate diagnostic test (100 of 181 [55%]), failure to create a proper follow-up plan (81 of 181 [45%]), failure to obtain an adequate history or perform an adequate physical examination (76 of 181 [42%]), and incorrect interpretation of diagnostic tests (67 of 181 [37%]).”

Gandhi, T. K., et al. (2006). “Missed and Delayed Diagnoses in the Ambulatory Setting: A Study of Closed Malpractice Claims.” Annals of Internal Medicine 145(7): 488-W183.


From a study researching anticoagulant test utilization: ” The pervading mantra that [non-vitamin K anticoagulants] do not require laboratory monitoring is countered by ongoing recognition that laboratory testing for drug effects is needed in many situations. Moreover, since these agents “do not require” laboratory monitoring, some clinicians inappropriately take this to mean that they do not affect hemostasis tests.”

Favaloro, E. J. and G. Lippi (2015). “Laboratory Testing in the Era of Direct or Non–Vitamin K Antagonist Oral Anticoagulants: A Practical Guide to Measuring Their Activity and Avoiding Diagnostic Errors.” Semin Thromb Hemost 41(02): 208-227.


A study to determine sources of diagnostic error: “studies performed on the pre-pre-analytical phase (initial procedures performed outside clinical laboratory or, at least in part, beyond the control of laboratory personnel) confirm that failure to order appropriate diagnostic tests (laboratory tests included) makes up 55% of observed breakdowns in missed and delayed diagnosis in the ambulatory setting and 58% of errors in emergency departments.”

Plebani, M. (2015). “Diagnostic Errors and Laboratory Medicine – Causes and Strategies.” EJIFCC 26(1): 7-14.


A study on 25 years of malpractice claims: “We analysed 350 706 paid claims. Diagnostic errors (n=100 249) were the leading type (28.6%) and accounted for the highest proportion of total payments (35.2%). The most frequent outcomes were death, significant permanent injury, major permanent injury and minor permanent injury. Diagnostic errors more often resulted in death than other allegation groups (40.9% vs 23.9%, p<0.001) and were the leading cause of claims-associated death and disability. More diagnostic error claims were outpatient than inpatient (68.8% vs 31.2%, p<0.001), but inpatient diagnostic errors were more likely to be lethal (48.4% vs 36.9%, p<0.001). The inflation-adjusted, 25-year sum of diagnosis-related payments was US$38.8 billion (mean per-claim payout US$386 849; median US$213 250; IQR US$74 545–484 500). Per-claim payments for permanent, serious morbidity that was ‘quadriplegic, brain damage, lifelong care’ (4.5%; mean US$808 591; median US$564 300), ‘major’ (13.3%; mean US$568 599; median US$355 350), or ‘significant’ (16.9%; mean US$419 711; median US$269 255) exceeded those where the outcome was death (40.9%; mean US$390 186; median US$251 745).”

Saber Tehrani, A. S., et al. (2013). “25-Year summary of US malpractice claims for diagnostic errors 1986–2010: an analysis from the National Practitioner Data Bank.” BMJ Quality & Safety.  http://qualitysafety.bmj.com/content/qhc/early/2013/03/27/bmjqs-2012-001550.full.pdf


Study utilizing physician self-report surveys: “Errors occurred most frequently in the testing phase (failure to order, report, and follow-up laboratory results) (44%), followed by clinician assessment errors (failure to consider and overweighing competing diagnosis) (32%), history taking (10%), physical examination (10%), and referral or consultation errors and delays (3%). ”

Schiff, G. D., et al. (2009). “Diagnostic error in medicine: analysis of 583 physician-reported errors.” Arch Intern Med 169(20): 1881-1887.


I could list many many more but I think you can see the point.  Consistently diagnostic errors relating to ordering and interpretation of laboratory tests are a major threat to patient safety.  We have known about the issue within the laboratory for a long time that could be measured in decades.  Finally there is data coming through that is showing the rest of healthcare what we in the laboratory already knew!

This is why the DCLS is so desperately needed!!!

There is a very evident gap between the physicians and the laboratory and it is up to us to protect our patients by using the knowledge and skills that we have to aid physicians so that the right test is ordered and the right time and interpreted correctly.

This is not just a American initiative, but patient safety is an International issue.  Information about the DCLS has even peaked the interest of the International Federation of Biomedical Laboratory Scientists (IFBLS).  Check out their Facebook page here https://www.facebook.com/bls.mlt/


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