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Yes, CMS requires clinical labs to submit to external proficiency testing under CLIA'88. The College of American Pathologists is a designated accrediting body a

Yes, CMS requires clinical labs to submit to external proficiency testing under CLIA'88. The College of American Pathologists is a designated accrediting body and the one I'm used to using. You are not allowed to do anything out of the ordinary with proficiency testing samples. You can't send them out to someone else and report what they reported to you. You just report the results. If you fail, they test you again. If you fail again, you're on probation. If you fail a third time, you're not allowed to report that analyte any more. Results of proficiency testing are reviewed on site in a bi-annual inspection. Officially there are 3 inspections: Joint Commission, CAP, and FDA, that all inspect the lab. Generally, the Joint Commission folks and FDA folks ask for your CAP certificate, and if it's good, they just skip all those items. CAP does not mess around. They will fly to the ends of the earth, they will cite you, they may decertify you. And then no one in the lab gets paid and they have to find new jobs. So, yeah, rest assured, labs work really hard to make sure they report honestly and accurately. Better to fail an occasional proficiency test and repeat, than get sideways on the inspection.

a9h74j 5y ago
I was working in a hospital when they discovered the blood lab was not prepared for the Joint Comission, and I saw the panic based on the scale of consequences you describe. My question refers to blinded testing meaning the lab in question does not know which, and handles, [in this case unexposed swabs from the factory] and it might range around 1-2% of samples on a continuing basis. To me that is the more industrial and continuous connotation of "QC". And the potential importance of "blind" testing. AFAIK, in any hospital lab there are tests which are still sent out, because they are either more challenging to build and train the right [accurate, low-error] procedures around, or too rarely done for the local investment. What if PCR tests for Covid were also too challenging to ramp up to mass scale in a regional startup lab? There are reports around of horrible controls -- perhaps true or not. That is something sending "blinded" samples through, proportional to mass testing being done, could disclose. Again, in the industrial setting there is the procedure you reported to the last ISO9000 auditor, and there is the actual procedure. The true spirit of that is that you should also build in procedures to detect when the production procedures are not being followed. Again back to ongoing QC.
- killjoywashere 5y ago
  Um, the samples submitted by the external auditor may be positive or negative. And clinical labs re-validate tests routinely, including drawing samples from our own lab personnel. But we don't have dummy patients in the electronic medical record tied to perfectly healthy actors coming in to donate 7 mL of blood in a red top.
  - a9h74j 5y ago
    Yes, surely for established labs with a culture of competence, care, and conscience, which I am sure is the norm in your parts of the world. I suspect we are framing in terms of two different, almost non-intersecting kinds of institution. My impression is of reports of "startup" regional labs which have scaled immediately in a pandemic, reportedly hired off the street (not people whose specific vocation and training and life-choice is toward lab technician or manager or scientist), and have resulted in anecdotal reports -- all heresay technically -- of swabs being left lying about in quantity, picked up off the floor, etc etc etc. To me these reports -- perhaps false -- do not intersect with the concern with detail in a lab that knows how to prevent cross-contamination when running at very high PCR amplifications. I am not bringing any new evidence to this, so I will leave it with clarifying the focus of my concern. I appreciate your standing up for the integrity and integrity-of-process in established labs. -- s/the lab in question/the startup lab in question/ a level or two up

a9h74j 5y ago

I was working in a hospital when they discovered the blood lab was not prepared for the Joint Comission, and I saw the panic based on the scale of consequences you describe. My question refers to blinded testing meaning the lab in question does not know which, and handles, [in this case unexposed swabs from the factory] and it might range around 1-2% of samples on a continuing basis. To me that is the more industrial and continuous connotation of "QC". And the potential importance of "blind" testing. AFAIK, in any hospital lab there are tests which are still sent out, because they are either more challenging to build and train the right [accurate, low-error] procedures around, or too rarely done for the local investment. What if PCR tests for Covid were also too challenging to ramp up to mass scale in a regional startup lab? There are reports around of horrible controls -- perhaps true or not. That is something sending "blinded" samples through, proportional to mass testing being done, could disclose. Again, in the industrial setting there is the procedure you reported to the last ISO9000 auditor, and there is the actual procedure. The true spirit of that is that you should also build in procedures to detect when the production procedures are not being followed. Again back to ongoing QC.

killjoywashere 5y ago
Um, the samples submitted by the external auditor may be positive or negative. And clinical labs re-validate tests routinely, including drawing samples from our own lab personnel. But we don't have dummy patients in the electronic medical record tied to perfectly healthy actors coming in to donate 7 mL of blood in a red top.
- a9h74j 5y ago
  Yes, surely for established labs with a culture of competence, care, and conscience, which I am sure is the norm in your parts of the world. I suspect we are framing in terms of two different, almost non-intersecting kinds of institution. My impression is of reports of "startup" regional labs which have scaled immediately in a pandemic, reportedly hired off the street (not people whose specific vocation and training and life-choice is toward lab technician or manager or scientist), and have resulted in anecdotal reports -- all heresay technically -- of swabs being left lying about in quantity, picked up off the floor, etc etc etc. To me these reports -- perhaps false -- do not intersect with the concern with detail in a lab that knows how to prevent cross-contamination when running at very high PCR amplifications. I am not bringing any new evidence to this, so I will leave it with clarifying the focus of my concern. I appreciate your standing up for the integrity and integrity-of-process in established labs. -- s/the lab in question/the startup lab in question/ a level or two up