Based on the enormous response to our last blog, 7 Lesser-Known Biometric Screening Regulations, it is apparent that several people were still not aware that POINT-OF-CARE “FINGERSTICK” HbA1c SCREENINGS AT THE WORKSITE IS PROHIBITED UNDER FEDERAL REGULATIONS. We thought it would be beneficial to provide everyone with the supporting information we are providing to those who reached out.

Here is what you need to know:

1. Health screening vendors performing biometric screenings at employer worksites operate under a CLIA Certificate of Waiver.

2. All entities operating under a CLIA Certificate of Waiver MUST follow all manufacturers’ recommendations and use the product as intended according to the package insert.

3. The package inserts on ALL CLIA-Waived HbA1c testing products assert that the intended use for these products is LONG-TERM METABOLIC CONTROL OF PERSONS WHO HAVE DIABETES MELLITUS (not for screening others for diabetes risk).

4. As a result, performing CLIA-Waived HbA1c Fingerstick screenings on an employee population, which includes people who do not have diabetes mellitus, to determine their individual risk for diabetes is not the intended use and is therefore prohibited; such circumstances do not represent a CLIA-Waived setting.

There are two primary products for HbA1c testing in circulation listed below. Both are prohibited in a CLIA-Waived health screening environment.

Alere Afinion HbA1c
Technical Support Phone Number: 1 (877) 441-7440
Product Insert and Supporting Documentation

PTS Diagnostics A1cNow+
Technical Support Phone Number: 1 (877) 870–5610
Product Insert and Supporting Documentation

We invite you to call the Technical Support phone numbers above, ask for technical support on the specific product name above, and then ask the following question: “Can this product be used under a CLIA Certificate of Waiver to screen an employee population for diabetes risk?”

For thoroughness, we have called these numbers and here are the responses we received:

“You can only use it on people who are diabetic.”

“The intended use is the long term control of people who have diabetes. If you use a product other than how it is intended according to the package insert, that is considered off-label usage. And, that is something else entirely than whether something is CLIA-Waived or moderately complex. It’s not just the complexity it affects; off-label usage is non-recommended usage. So that’s really important to know.”

Even screening someone who self-reports that they have previously been diagnosed with diabetes is risky – testing once per year does not constitute long-term control or monitoring of the condition.

If you think your health screening vendor may not be subject to these regulations because they may operate under something other than a CLIA Certificate of Waiver, we invite you to check the CLIA database for their CLIA status by clicking on the link below.

http://wwwn.cdc.gov/clia/Resources/LabSearch.aspx#SearchResultsTop

When you see the search box below, type the health screening vendor’s name in the space for “Laboratory Name”; and then click “Search”.

CLIA Search Criteria

This search will return results like ours below.  If you see “Waiver” in the column labeled “Certification Type,” then the regulations prohibiting the usage of Point-of-Care “Fingerstick” A1c testing on employer populations apply to your vendor.

CLIA Search Results

If your wellness program currently involves Point-of-Care “Fingerstick” A1c testing at your worksite, please don’t leave your wellness program at risk to legal complaints from employees or to being shut down by CMS. Speak with us or someone else fluent in the regulations and make the change to a compliant program.

For additional information on Onsite Health Diagnostics contact us here.