Screening for diabetes risk

Offering hemoglobin A1c (HbA1c) testing as part of your workplace screening program is a wellness best practice to improve population health. Screening for HbA1c enhances the identification of those at risk for prediabetes, enabling you to identify those at risk of becoming high-cost claimants and intervene. If an employer only screens for glucose as part of an employer-sponsored wellness screening, they may be missing an important opportunity to give employees insight into their prediabetes or type 2 diabetes risk.

In order to drive participation in wellness screening programs, convenience is key. For many employers, adding convenience to a program means multiple screening options, including on-site events, as well as remote screenings, such as those offered at Quest Diagnostics Patient Service Centers (PSCs).

While all PSCs complete screenings using the venipuncture collection method, many employers use fingerstick screenings (also called point-of-care testing) at on-site events. Fingerstick screenings enable participants to leave their wellness screenings with results in hand. But, if you’re looking to include HbA1c testing in fingerstick screenings, you cannot do so using a point-of-care device due to current usage regulations and recommendations.

If you’re an employer who has seen the rise of the type 2 diabetes epidemic firsthand through the declining health of your employee population, and the consistent increases in your healthcare spend, is the “convenience” of same-day results really worth the cost of employees not knowing their long-term risk for type 2 diabetes? Is it worth the increased healthcare costs in the future that could be prevented?

Fingerstick screenings have grown in popularity because they give individuals results almost immediately. Fingerstick screenings attempt to identify the presence of possible conditions or disease risks, but they should not be a replacement for a physician’s care. As such, fingerstick analyzers (the machines used to analyze the 4 drops of blood for a fingerstick screening) are not approved to measure HbA1c for the purpose of alerting individuals to diabetes risk.

The Food and Drug Administration (FDA) has approved some point-of-care testing devices to be waived under the Clinical Laboratory Improvement Amendments (CLIA) as a means of monitoring HbA1c in those who have already been diagnosed with diabetes; however, no point-of-care testing machine has been approved for population-level screening programs. In fact, the user manuals for all point-of-care testing devices, including those that are CLIA-waived for HbA1c testing, state that the intended use of the device is for long-term monitoring of individuals with diabetes.

Any organizations offering on-site fingerstick screenings for employee wellness programs that include testing on point-of-care devices are not compliant with the FDA and CLIA.

While you may encounter vendors willing to test HbA1c on point-of-care testing devices, we recommend inquiring about FDA and CLIA regulations to prevent your wellness screening program from being non-compliant.

At Quest Diagnostics we offer HbA1c testing using the venipuncture collection method or our collection card testing option in order to stay compliant with FDA regulations and CLIA. Collection cards use a fingerstick collection to obtain the sample, but the analysis is completed in a Quest Diagnostics laboratory. Since the sample is tested on laboratory equipment, and not a point-of-care device, collection card testing is compliant with the FDA regulations and CLIA.

For any employer looking to secure the benefits gained with HbA1c testing— such as a population more aware of their diabetes risk coupled with reduced healthcare spending—we suggest using the venipuncture collection method for on-site events, or adding collection card to on-site fingerstick events. Not only will this give you the ability to test your population for HbA1c at on-site events, but your program will see these other benefits, as well:

• Venipuncture screening opens your program to a broader test menu, should you want to add additional tests (like eGFR or hsCRP) to screen for comorbidities, like heart disease or chronic kidney disease, in the future. These additional tests also allow your organization to funnel the right people into the right care, to make sustainable lifestyle changes. Adding collection cards to on-site fingerstick events also broadens the available test menu with select additional tests including HbA1c and prostate-specific antigen (PSA).
• Venipuncture and collection card screenings are more valued by physicians as the specimens are tested in a lab. This means that, when participants take their results to a primary care physician, the results are seen as clinical by the physician, and participants will be able to have a meaningful discussion with their doctor about their numbers and health risks and how to make any necessary lifestyle changes.
• Venipuncture screening at on-site events gives those who screen on site the same experience as participants who screen remotely at a PSC.

The overall goal of employee wellness screening programs should be to help individuals identify their health risks and take action to reduce these risks. This leads to savings for both the individual and the organization. HbA1c testing is the most effective way to identify risk for one of the most costly conditions: type 2 diabetes. In order to be compliant with FDA regulations and CLIA, HbA1c testing should never be conducted via fingerstick on point-of-care devices for population-level screening programs.