What Wellness Companies and Providers Should Know About Biometric Testing Laws

What Wellness Companies and Providers Should Know About Biometric Testing Laws

The Center for Health and Wellness Law often works with wellness companies and providers who want to conduct biometric screening tests as part of health fairs or health promotion events. Sometimes these events are held at the worksite as a benefit to employees, other times they may be open to the public. In either case, wellness companies and providers, such as nurses, doctors, dietitians, or health coaches, must be aware of legal restrictions and requirements involved when collecting “blood specimens,” either through finger stick or venipuncture.

There are two sources of law wellness companies and providers should address when planning biometric screening events:

  • Clinical Laboratory Improvement Amendments of 1988 (CLIA)
  • State Laboratory Laws


The federal Centers for Medicare and Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the United States through CLIA.[1] CLIA was established to strengthen federal oversight of clinical laboratories to ensure the accuracy and reliability of patient test results.[2] Federal law defines a laboratory to be a facility that performs certain testing on human specimens in order to obtain information that can be used for the diagnosis, prevention, or treatment of any disease or impairment of a human being; or the assessment of the health of a human being; or procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in a human body.[3] Given this broad definition, many workplace wellness biometric screening activities involve a CLIA “laboratory” at some point during the testing process. All facilities that meet the definition of “laboratory” under CLIA must obtain an appropriate CLIA certificate prior to conducting patient testing.[4] However, facilities that only collect or prepare specimens (or both), or only serve as a mailing service and do not perform testing, are not considered laboratories under CLIA.[5]

CLIA’s regulatory requirements vary according to the kind of tests each laboratory conducts.[6] Tests are categorized as:

  • Waived
  • Moderate complexity
  • High complexity[7]

Most onsite, point-of-care biometric screens in workplace wellness programs fall within the CLIA waived test category.[8] Laboratories that perform waived tests must obtain a certificate of waiver under CLIA.[9] Waived tests must meet the following criteria:

  • Are cleared by the FDA for home use;
  • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
  • Pose no reasonable risk of harm to the patient if the test is performed incorrectly.[10]

One can see a full list of the tests that are waived under CLIA, and the manufacturers of those tests, at https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf.

The significance of being categorized as a waived test is that there are fewer regulatory requirements for the laboratory conducting those tests. Laboratories eligible for a certificate of waiver must (1) follow the manufacturers’ instructions for performing the test;[11] and (2) meet the certificate of waiver requirements found at 42 C.F.R. §§ 493.35–493.39.[12]

The certificate of waiver requirements include:

  • Filing an application with the Department of Health and Human Services (HHS)
  • Making records available and submitting reports to HHS to ensure compliance with 42 C.F.R. § 493.15(e)
  • Agreeing to permit announced and unannounced inspections by HHS
  • Remitting a certificate of waiver fee[13]

The requirement to follow the manufacturers’ instructions for performing the test can be critical for some biometric tests. For example, some biometric tests, such as A1c tests, prohibit the use of the test for screening purposes; rather, the manufacturer may intend its test to be used for monitoring A1c levels in those who have already been diagnosed with diabetes. Wellness program designers should check whether the CLIA-waived biometric screening tests they use comply with manufacturer instructions.[14]

The certification is good for two years.[15] After that, the laboratory must renew the certificate.[16]

It is important for wellness professionals and organizations that include screening activities as part of a wellness program to assess whether the appropriate CLIA certificates have been issued.

State Laboratory Laws

State laws can sometimes override or go beyond CLIA requirements, including for waived tests.[17] State regulations may limit the tests that can be run, dictate who can run certain tests, require certain practitioner oversight, or regulate the way results can be provided or reported to employees.[18] There are also state laws that address transport, storage, and disposal of biometric specimens.[19] “When state or local regulations governing laboratory testing are more stringent than the federal CLIA requirements, they supersede what is required under CLIA.”[20]

For example, Massachusetts requires a letter of approval before conducting a health promotion screening program.[21] Specifically, that rule states that “any person or entity who operates a health promotion screening program shall apply for a letter of approval in accordance with 105 CMR 180.030(D).” [22] “Health promotion screening program” is defined as a “laboratory testing service which examines material derived from a human body for the purpose of promoting health awareness and education among the general public by early detection of disease and/or associated risk factors.   Health promotion screening tests are not used for the purpose of providing clinical diagnosis or treatment to patients.”[23]  Thus, letters of approval are required of “any person or entity” that conducts a screening program for the purpose of promoting health awareness.

In addition to requiring letters of approval, states may limit the type of tests that can occur at health screening events. Massachusetts limits health screening tests to:

  • Cholesterol (capillary whole blood)
  • Erythrocyte Protoporphyrin (capillary whole blood)
  • Fecal Occult Blood
  • Hemoglobin (capillary whole blood)
  • Hematocrit (capillary whole blood)
  • HDL Cholesterol (capillary whole blood)
  • Glucose (capillary whole blood)
  • Pregnancy Test, qualitative[24]

Health Promotion Screening Programs do not need a clinical laboratory license issued by the State of Massachusetts.[25]

It is important to note that the majority of the approved tests for health promotion screening programs in Massachusetts must be “capillary whole blood,” which is not blood collection by venipuncture, but rather, through finger stick. New Hampshire and Massachusetts have “collection station” laws that allow laboratories licensed in those states to withdraw specimens through venipuncture from patients and to send those specimens to a laboratory for testing.[26]  Other entities that may operate collection stations in Massachusetts are licensed hospitals or clinics or out-of-state laboratories accredited or licensed in accordance with federal law.[27] Thus, non-licensed entities such wellness vendors could not operate a collection station in those states.

In New York, health fairs can conduct blood draws only if operated by a clinical laboratory under permit, with the prior approval of the New York Department of Health, and there must be a general order from a licensed physician in charge.[28]

Some states also prohibit direct access testing (DAT), which refers to laboratory tests that are allowed without a physician’s order.[29] In those states that prohibit DAT, physicians must order the test and the results must be reported to the ordering physician.[30] DAT prohibitions may cause problems for wellness professionals who are not licensed physicians when trying to order lab tests as part of their practice. Moreover, some states may require certain licenses or certifications of persons drawing blood for screening purposes.[31]

An examination of each state’s laws that govern biometric screening is beyond the scope of this blog post. Nevertheless, wellness professionals and companies should be aware that such state laws exist, and should consult with legal counsel when assessing a wellness program’s compliance with those laws.


[1] “Biometric Health Screening for Employers,” supra note 179, at 1246.


[2] CMS, “Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations, Fact Sheet,” https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/directaccesstesting.pdf.


[3] Id. (citing 42 C.F.R. § 493.2).


[4] Id.


[5] 42 C.F.R. § 493.2 (definition of laboratory).


[6] CMS, “Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations, Fact Sheet.”


[7] Id.


[8] “Biometric Health Screening for Employers,” supra note 179, at 1246.


[9] 42 C.F.R. § 493.15.


[10] 42 C.F.R. § 493.15(b).


[12] 42 C.F.R. § 439.15(e).


[13] 42 C.F.R. §§ 493.35–493.37. Current CLIA certificate of waiver fee is $150 for two years. See https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/clia_certificate_fee_schedule.pdf.


[14] Kyle Alexander, Point-of-Care “Fingerstick” A1c Health Screenings Still Prohibited (Aug. 17, 2016), available at https://onsitehealthdiagnostics.com/blog/a1c-fingerstick-health-screenings-prohibited/ (last visited Dec. 30, 2020).

[15] 42 C.F.R. § 493.37(e).


[16] 42 C.F.R. § 493.37(f).


[17] “Biometric Health Screening for Employers,” supra note 179, at 1246.


[18] Id.


[19] See, e.g., Wis. Admin. Code §§ NR 526.07-08 and 526.10 (addressing transport, containment, and handling of infectious waste).


[20] See https://www.cdc.gov/mmwr/pdf/rr/rr5413.pdf, at 9.

[21] See 105 CMR § 180.030(A).

[22] Id.

[23] 105 CMR § 180.010.

[24] Massachusetts Division of Healthcare Facility Licensure and Certification Fact Sheet, Apply for Approval of Health Promotion Screening Laboratory Testing, available at https://www.mass.gov/how-to/apply-for-approval-of-health-promotion-screening-laboratory-testing (last visited Dec. 30, 2020).

[25] See 105 MA Gen Stat. Ch. 111D §4.

[26] See e.g., New Hampshire Rules HE-P 817.03 and HE-P 817; Massachusetts Division of Healthcare Facility Licensure and Certification Fact Sheet, Apply for Collection Station Approval, available at https://www.mass.gov/how-to/apply-for-collection-station-approval (last visited Dec. 30, 2020).

[27] Id.

[28] N.Y. Code Section 58-1.7.

[29] “Biometric Health Screening for Employers,” supra note 179, at 1246.


[30] Id.


[31] See e.g., Calif. Bus. & Prof. Code § 1242 (requiring license to withdraw blood for clinical laboratory tests); Louisiana Revised Statutes Title 37 §1323; Nevada Medical Laboratory Licensing Fact Sheet, available at http://dpbh.nv.gov/Reg/MedicalLabs/Medical_Lab_Personnel_Licensing/ (last visited Dec. 30, 2020); Washington RCW 18.360.020.

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