POC COVID EUA testing
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Those of you running POC COVID tests (especially the BD Veritor kit) - do you allow your areas to utilize COVID kits after they have expired?
We had one of our CAP labs get literature from CAP that they could use expired kits due to the EUA, now our purchasing department would like our TJC accredited POC areas to utilize expired COVID kits as well and I don't really agree with that. I reached out to TJC and their response is below:
To address the concern about SARS-CoV-2 testing reagents and swab supply shortages during the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) will allow laboratories and testing sites to use expired SARS-CoV-2 test kits, reagents, and swabs—unless doing so deviates from the test manufacturer’s authorized instructions for use.
The Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines state that “when in-date reagents are unavailable, it may become necessary to frame written policies for their temporary use beyond their expiration dates until non-expired supplies become available. Under no circumstances, however, should a laboratory adopt policies that would allow for the regular use of expired reagents.”
According to these guidelines, laboratories and testing sites may use expired supplies until non-expired supplies become available, provided that there are policies and procedures in place to ensure that reagents are performing as expected. For example, any expired supplies must pass quality control tests with each assay run.
The IFU does state in the warning and precaution section, "Do not use this kit beyond the expiration date printed on the outside carton".
So how would you proceed? Thoughts?
We had one of our CAP labs get literature from CAP that they could use expired kits due to the EUA, now our purchasing department would like our TJC accredited POC areas to utilize expired COVID kits as well and I don't really agree with that. I reached out to TJC and their response is below:
To address the concern about SARS-CoV-2 testing reagents and swab supply shortages during the COVID-19 public health emergency, the Centers for Medicare & Medicaid Services (CMS) will allow laboratories and testing sites to use expired SARS-CoV-2 test kits, reagents, and swabs—unless doing so deviates from the test manufacturer’s authorized instructions for use.
The Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines state that “when in-date reagents are unavailable, it may become necessary to frame written policies for their temporary use beyond their expiration dates until non-expired supplies become available. Under no circumstances, however, should a laboratory adopt policies that would allow for the regular use of expired reagents.”
According to these guidelines, laboratories and testing sites may use expired supplies until non-expired supplies become available, provided that there are policies and procedures in place to ensure that reagents are performing as expected. For example, any expired supplies must pass quality control tests with each assay run.
The IFU does state in the warning and precaution section, "Do not use this kit beyond the expiration date printed on the outside carton".
So how would you proceed? Thoughts?
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But, if you are experiencing a major supply shortage, then you would probably need the following in place:
Deborah C. Martuch, BSMT(ASCP), CPP
We also use the BD Veritor kit and, ironically, were in the position of throwing away hundreds of test kits because our local supplier kept sending us short dated kits and we couldn't use them in time. Ridiculous amounts of waste - at a time when other countries were reporting they couldn't even get test kits. I am shocked that even under EUA conditions, there would be an allowance for using expired supplies. Every fiber of my lab being says "no", lol....