Population health screenings and Hemoglobin A1c testing in fingerstick screening programs: what you need to know
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 employers 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.
HbA1c reflects the average concentration of glucose (sugar) in the blood over a 2-3 month timespan prior to the screening, while a glucose measurement only reflects an individual’s blood sugar at the point in time of the screening. Glucose measurements change by the minute, and are influenced by recent food intake, stress, exercise, and other factors. So, when an employer is only measuring fasting glucose in their wellness screenings, they are not looking at the long-term risk factor, and therefore, are likely overlooking many who are actually at risk for prediabetes and type 2 diabetes.
Hearing that statistic, it’s easy to see why organizations should offer HbA1c testing. Type 2 diabetes is a very costly condition for self-insured employers, and having the ability to use HbA1c to identify future high-cost claimants when they are still in the prediabetes range (and their conditions are still reversible), is a huge benefit. However, many organizations still do not offer HbA1c as part of their workplace wellness screening though. Why is that?
The popularity of fingerstick onsite event screenings and what to do about HbA1c
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 onsite 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 onsite events, which enable participants to leave their wellness screenings with results in hand. But if you’re looking to include HbA1c 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?
HbA1c testing on fingerstick analyzers
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 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 organization offering onsite fingerstick screenings for employee wellness programs that include HbA1c testing on point-of-care devices are not compliant with the FDA and CLIA.
So, how should I add HbA1c testing to my onsite screening program?
While you may encounter vendors willing to test HbA1c on point-of-care testing devices, we recommend asking questions in regard to dealing with the FDA and CLIA regulations in order to prevent your wellness screening program from being non-compliant.
At Quest Diagnostics Health & Wellness, we offer HbA1c testing using the venipuncture collection method or our Qcard™ testing option in order to stay compliant with the FDA regulations and CLIA. Qcard™ is a method that uses fingerstick collection to obtain the sample, but the analysis is completed within a Quest Diagnostics laboratory. Since the sample is tested on laboratory equipment, and not a point-of-care device, Qcard™ 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 onsite events, or adding Qcard to onsite fingerstick events. Not only will this give you the ability to test your population for HbA1c at onsite 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 Qcard also broadens the available test menu with select additional tests including HbA1c and prostate specific antigen (PSA).
- Venipuncture and Qcard screenings are more valued by physicians as the specimens are tested in a lab. This means that, when taking 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 onsite 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 their risk. This leads to savings for 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. To learn more about HbA1c testing via the venipuncture collection method, and other wellness screening best practices, download our Best Practices Guide.
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