The Search for a High Quality Biometric Screener: What Questions Should be Asked?

COLA Certificate of Accreditation

In recent years, there has been a proliferation of corporate wellness programs. There are many reasons, not the least of which is the rising cost of healthcare. Employers, particularly self-insured employers, have realized that preventing or reversing the onset of chronic disease can have a tremendously positive impact on their workforce’s health and well-being, as well as the company’s bottom line.

As part of the initial strategic planning for a corporate wellness program, most employers will first engage in various types of information gathering in an effort to evaluate the overall health situation of their population. This can be done in various ways. Employers can review medical claims data, HR data (absenteeism, disability rates, etc.), and obtain baseline biometric screening data.

So that they can measure the success of their corporate wellness programs, Human Resources professionals design corporate wellness programs with future measurement in mind. However, finding data that lends itself to comparison year after year is difficult, and most data has drawbacks. Claims data is limited, because only the data for those who seek medical attention can be reviewed. Those who have risk factors that could lead to chronic disease, but who have not been diagnosed yet, are not identified. Human Resource data is limited as well. Absenteeism can be for a lot of reasons—reasons unrelated to chronic disease. The same holds true for disability absences. While reviewing both claims and HR data certainly have value, biometric screening has many advantages.

Fundamentally, biometric screenings give a quick snapshot of one’s overall risk factors for heart disease and diabetes, and the information can be gathered rapidly and in a manner designed to influence positive behavior change. Most employers choose to have the blood testing (cholesterol, glucose, etc.) performed using point of care testing equipment, so that employees can immediately receive results while still in the presence of someone who can explain their values. The screening staff can help employees sign up for wellness programs right away, during this “teachable moment.” Also, point of care equipment utilizes a fingerstick with only a few drops of blood, so this method is generally preferred by employees.

However, the fingerstick testing results are only as good as the quality of the company doing the testing. With the growth of the corporate wellness industry, companies have sprung up rapidly, with very little oversight. This leads to the question, who is monitoring the quality of the companies that provide fingerstick testing?

From a federal standpoint, one must obtain a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver in order to do the testing. These regulations establish minimum quality standards for all “waived testing” testing with regard to accuracy, reliability and timeliness of patient test results. Most of the testing done during biometric screenings is considered “waived,” which means that the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have determined are “so simple that there is little risk of error.”

Laboratories performing waived testing must enroll in the CLIA program, pay fees biennially, and follow the manufacturer instructions. There are no routine inspections, not even for the initial certification.

Some states have recognized that there should be additional oversight, and there are approximately a dozen who require an additional “license,” “permit,” “license exemption,” or “certificate,” and each of these states has its own unique requirements in order to perform waived testing. But even so, there are very few states who actually perform inspections.

Of these states with additional regulations, a few require “proficiency testing.” Proficiency testing is accomplished by a laboratory testing a blind sample, in the same manner in which it tests people. The results are compared against a peer group utilizing the same testing equipment. Therefore, there is no “right answer”, rather it is graded based on the results obtained by other participants in the peer group. To be statistically significant, proficiency providers require peer groups of at least 10, but a much higher number of participants is desirable.

Although proficiency testing is one indicator of testing accuracy (for a few samples each year), it does not involve any direct inspection of laboratory practices, and it is only performed by a small fraction of waived laboratories.

So, how can employers be certain that they are hiring a reputable company to perform biometric screenings? One, how can they be certain that the screening company’s testing is accurate and reliable, and two, how can they be certain that the employees will receive quality healthcare—because ultimately, it is healthcare. The quality must compare to that of a doctor’s office or hospital. This includes being mindful of privacy and security and being HIPAA compliant.

Although the biometric screenings are just screenings, and not diagnostic in nature, it’s imperative that the results are accurate and reliable. If results are too low for tests such as cholesterol or glucose, employees who need to seek medical attention will not be identified. If results are too high erroneously, employees will be caused unnecessary worry, and it will lead to increased healthcare dollars spent needlessly in follow-up. In outcomes-based corporate wellness programs, employees may be dinged for inaccurate results. That “teachable moment” could be based on the wrong numbers.

The clinical operations are equally important. Anytime a clinician causes a break in the skin’s integrity (i.e., a fingerstick), there are many factors to consider. Are proper procedures being followed? Did the screener wash her hands? Is she wearing gloves? Does she dispose of the biohazardous materials correctly? A surprising number of people become “faint” during a fingerstick, does the screener know how to deal with this? Employees deserve high quality care, and as the one arranging the screenings, the employer has a responsibility to see that they receive it.

Biometric screening companies may choose to undergo added scrutiny by pursing voluntary accreditation through the Commission on Laboratory Accreditation (COLA) or Joint Commission on Healthcare Organizations (JCAHO). Pursuing voluntary accreditation is one way a screening company can make statement about its commitment to quality. It involves a detailed review of all its policies and procedures, as well as a rigorous inspection. If any deficiencies are identified, they must be remedied before accreditation may take place.

In order for an employer to gauge the quality of a biometric screener, the following questions should be asked:

  1. In addition to the Certificate of Waiver, do you hold any other state specific credentials? If so, what type of requirements had to be met?
  2. Have you ever been inspected? If so, by whom? What type of deficiencies were identified, and how were they addressed?
  3. Do you perform proficiency testing? If so, what were your last results? If there were any failures, how were they addressed?
  4. Do you hold any additional accreditations, such as COLA or JCAHO? What were the results of your last inspection?
  5. Do you have a Registered Nurse on site? What are the credentials of the screeners if not Registered Nurses? Are they CPR certified? Do you have an automatic external defibrillator (AED) and eye wash?
  6. Do you have an Occupational Safety and Health Administration (OSHA) plan? Do you offer your screeners the Hepatitis C vaccine? (Although screeners may refuse this, it is a sign of a robust exposure control plan if it is offered by the company).
  7. Are you HIPAA compliant? Do you have a Notice of Privacy Practices? Do you have security measures such as encryption and isolated servers? When was the last audit of your IT services?
  8. Do you hold professional liability insurance, and if so, in what amount?

If the company has done its due diligence, the questions should be easily and comfortably answered. Ultimately, biometric screening may be part of the wellness industry, but the quality with which it is performed must be equivalent to that of a medical facility.