Finger-stick A1c: Compliance Related Documents
Since our first communication regarding point-of-care A1c screenings NOT being compliant with CLIA, we have had dozens of calls with concerned consultants, brokers & large employers, many of whom are now making the correct choice and switching away from fingerstick A1c. The primary point of interest from these calls has been what documentation we can provide in support of our position. Please see our line of reasoning presented below along with our 3 documents available for download that, together, provide clear evidence that CLIA and CMS prohibit point-of-care (finger-stick) A1c at a biometric screening event.
- OHD verified with CMS in person that performing point-of-care A1c biometric screenings is NOT compliant with federal regulations (CLIA).
- We asked CMS for something in writing that we could share with the marketplace, stakeholders and our customers, and in response, CMS sent one of the documents you will receive in the download packet. In this document from CMS, please see the highlighted sections on pages 3 through the top of page 5. In those sections, it is made clear that ALL manufacturer’s recommendations on the product insert must be followed including the “limitations” sections.
- The product inserts for the A1c test kits in use by biometric screening competitors prohibit the use of the product for the “screening or diagnosis of diabetes.” See the product insert in the download packet, which is for the most popular product, A1cNow—manufactured by Polymer Technology Systems. A follow up call with Polymer Technology Systems revealed that they also inform their distributors that the A1cNow product cannot be used for biometric screenings.
Therefore, because the product inserts prevent the use of the kits for screening purposes and CLIA regulations require biometric screening companies operating under a CLIA Certificate of Waiver to follow ALL manufacturer’s instructions and recommendations on the product insert, performing point-of-care A1c biometric screenings in order to determine who may need blood sugar related programs or treatment is not compliant.
To augment the information above, an FDA letter is also in the download packet, which was released years earlier and informs manufacturers that point-of-care A1c testing kits are only approved to help people, already diagnosed with diabetes, manage their condition. Biometric screening vendors have tried to take the position that because no screening vendors diagnose, they are within bounds. However, the information above and our conversations with CMS representatives confirm otherwise.
Read our blog article posted on August 17, 2016, about point-of-care “fingerstick” a1c health screenings and how they are still prohibited.