I think must applied the role of ISO is firstly.

" Medical laboratory errors impact the workload of about 50% of hospital departments". Where does this come from? Compared to what?

Thanks for asking about the link to clinical cost. Would you agree with this?

The link to clinical cost is based on Gallaher M, Mobley LR, Klee G, and Schryver P. The impact of calibration error in medical decision making. Prepared for National Institute of Standards and Technology Chemical Science and Technology Laboratory. Planning report 04-1; May 2004.

"Based on analysis of over 89,000 patients receiving serum calcium tests

at the Mayo Clinic in 1998–1999, we find that the number of follow-up

procedures, and hence health care costs, is directly related to initial

calcium test values. Based on interviews with laboratory managers and

equipment manufactures, it was determined that calibration error has the

potential to lead to bias of 0.1 to 0.5 mg/dL in up to 15 percent of calcium

tests.

Analytic bias affects health care costs by increasing the number of

follow-up tests performed for patients with elevated calcium levels. It is

estimated that the cost impact associated with an analytical bias of

0.1 mg/dL could range from $8 to $31 per patient (receiving a calcium

test). For an analytical bias of 0.5 mg/dL, which was the approximate

upper bound identified during interviews, the potential health care cost

increase ranged from $34 to $89 per patient having a calcium test.

With approximately 3.55 million patients per year receiving screening

serum calcium tests being affected by systematic bias, the potential

economic impacts range from $60 million to $199"

I looked at the list of departments by workload at our local hospital:

- laboratory tests; CT Scans; diagnostic ultrasound; Emergency Dept; Visits; MRI; nuclear medicine; outpatient clinic visits; radiography; cardiac catheterization; chemotherapy visits; interventional radiology; radiation treatments; admissions; surgical/OR Cases;

- these are not likely impacted by lab error: births hip replacement knee replacement mammography open heart surgeries pacemakers

Here in my lab, we follow Westgard rules. https://www.westgard.com/. We feel this is a very good mix of strengthening QC, continuing workflow and cost effectiveness. I know results near decision levels are always going be scrutinized. What I don’t want to see is continuous repeating of the test until the provider gets the result they expect. We look for trending according to westgard rules and are able to get repeatable results.

I think before a result can be considered an error, “error” should be defined. For QC we use +/-2 SD and for patient results we expect +/-5% of the “actual” result. We run precision, carry over and use blind specimens to access this. After years of experience, I have a lot of confidence in our results, but I am always happy to repeat a test if it is in question.

Unfortunately most errors are pre-analytical and not fully under laboratory control.