Colorado Department of Public Health and Environment Laboratory crisis that concerns blood ethanol content by HS-GC-FID teaches us yet again the critical role that quality assurance (QA) is supposed to play in forensic laboratories. It is part of any quality management system. In all laboratories, the QA officer should be someone who is wholly independent from the bench and not part of the routine analysis chain of events. The QA officer should not be supervised by those who supervise the bench. The QA officer should only report to the director of the laboratory.

QA is the essential double check and the implementation of quality checks and procedures. It makes sure that the procedures are followed. If they are properly empowered they are supposed to immediately correct any failure and mistake. The QA officer must have the mindset to seek and want to falsify the data of the analyst. The QA officer must work in an environment that encourages them to do so.

In addition, it is essential that the QA officer know more about the process, the theory and the meaning of the data produced than the bench analyst. Otherwise, we have the blind leading the blind.

All we have to do is look at the investigation in the Colorado Department of Public Health and Environment to see what typical QA is like in the forensic world.

Just look at this from the full report:

EMPLOYEE 1 adds: “All blood alcohol test results are currently reviewed by EMPLOYEE 4. Under our old policy, another analyst reviewed the test results rather than a supervisor. Currently, the analysts are required to flag results that need to be retested by placing a note on the test results that are forwarded to a supervisor after the retest is performed. During my training, I was not taught to make a notation on my test results indicating that a sample had been retested.”

 

It has almost got to the point that when there is a new laboratory scandal discovered, it provokes a yawn in me. Isn’t that sad?!? You know what happened when there was half the scandals in the clinical world? The Clinical Laboratory Improvement Act (CLIA)!

Where is FLIA?!?!?

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