Posted by Sten Westgard, MS
A recent news investigation produced a litany of laboratory errors. Can you guess which of these lab errors actually happened?
- a blood screening test fails to identify a critical blood disorder in a pregnant woman. Her child dies 3 weeks after being born
- an HIV test falsely identifies a husband as HIV positive. The couple separates, the wife unwilling to trust the husband anymore.
- a paternity test sample gets switched: a father is falsely told that his daughter is not his biological child. The family splits up. Nearly 4 years later, the laboratory contacts him and tells him he was the father. The father-daughter bond remains broken.
The answer, after the jump.
Unless you're new to the field of laboratory medicine, you probably guessed the real answer was "all of the above." All of those laboratory errors occurred.
The stories of these lab errors are found in a lengthy article from the Milwaukee Journal-Sentinel, "Weak oversight allows lab failures to put patients at risk" by Ellen Gabler.
What sets this article apart is that it doesn't focus on a single splashy incident. It's not just piling onto a scandal, the journalist actually tries to dig deeper. It doesn't try to blame one lab or one technologist for an error - it looks to the root causes.
One root cause: private accreditation organizations that don't disclose their inspection reports to the public. In one case, a laboratory with problems was caught only when the Federal government did a spot-check on a laboratory accredited by The Joint Commission.
"The Joint Commission - a nonprofit that has long touted itself as a quality leader with rigorous performance standards - failed to identify nine major categories of violation at Byrd [hospital] that could cause patients serious harm, according to federal records. After identifying problems that the Joint Commission missed, regulators forced Byrd to hire a technical director who will supervises the lab."
Gabler points out that the US inspection regime has set a ridiculously low bar for performance: only 90 sanctions were issued to laboratories in 2013, citing less than 1% of the 35,000 laboratories that do moderate and high-complexity testing. Do we really think we're that good?
In 2013, government audits of The Joint Commission laboratory inspections found that 21% (or 9 out of 43) audited inspections, were substandard. The government allows up to a 20% disparity rate in the inspection, but this exceeded even that. In contrast, CAP had "only" a 17% disparity rate in their audited inspections. In 2012, that disparity rate was 11%.
It's a good read, a thorough read, and one that only rarely makes it into the public sphere.