What’s Missing from Clinical Laboratory Inspections
At the Westgard Workshop, most of the participants were from clinical laboratories and I was impressed with how smart these people are. I also got a sense of a tremendous regulatory burden. From the CAP CD, I obtained at the Workshop:
The mission statement of the CAP Laboratory Accreditation Program is:
“The CAP Laboratory Accreditation Program improves patient safety by advancing the quality of pathology and laboratory services through education and standard setting, and ensuring laboratories meet or exceed regulatory requirements.”
I have had mixed feelings about inspections that certify quality and have previously reported my experience with an industry quality program – ISO 9001 (1).
Here’s my assessment of clinical laboratory inspections to certify laboratories. It would seem that the premise of these inspections is to ensure that specific policies and procedures are in place and executed as proven largely by documentation, which guarantees high quality. So what’s missing? As far as I can tell – and it is with great difficulty to read through these materials – that there is no measurement of error rates. Without such measurements, quality is unknown.
The regulatory bodies would describe a list of errors and their associated severities. The severities would be given numerical values such as the VA hospital system which uses 1-4. Every clinical laboratory would record each error (failure mode) that occurs in their laboratory, its severity, and its frequency (default frequency is of course 1). They would multiply frequency x severity for each unique error (failure mode), add this up and get a rate by dividing by the number of tests reported per year.
Failing to count errors would be a serious violation.
This would be the start of a new premise for the regulatory bodies. Measure quality – if it’s unacceptable, the clinical laboratory would suggest and implement process changes. It’s a simple closed loop process. With emphasis on measurement, reliance on documentation should decrease and inspections should be less burdensome.
1. Krouwer JS. ISO 9001 has had no effect on quality in the in-vitro medical diagnostics industry. Accred. Qual. Assur. 2004;9:39-43