Ophthalmic staff have a role to play regarding laboratory testing.

While your services as a technician are always in high demand, you can play an even greater role within the practice by being an active compliance team member. This is especially true as it relates to maintaining compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

These amendments apply federal regulatory standards to all facilities that test human samples (eg, body fluid and tissue) for the purpose of health assessment or the diagnosis, prevention, or treatment of disease (research excluded). The CLIA program aims to ensure quality laboratory testing, and practices or laboratories that perform CLIA-covered tests must be certified by their state as meeting certain standards.

Your role includes the following three primary duties.

1. Check whether your practice is certified.

There are five types of CLIA certificates, and each covers a certain test complexity level. Eye-care practices that perform some simple, low-risk tests — such as tear osmolarity (TearLab) and MMP-9/gelatinase B (InflammaDry [Quidel]) for dry eye or other testing (eg, COVID, glucose) — are required to obtain the Certificate of Waiver (COW). This is for facilities that perform only FDA-waived tests (for a full test list, see tinyurl.com/OPCLIA1 ).

To apply for the COW (or any other CLIA certification type), fill out Form CMS-116 (tinyurl.com/OPCLIA2 ). The Certification Quick Start Guide (tinyurl.com/OPCLIA3 ) is a helpful resource. When the application is complete, send it to the appropriate state agency (tinyurl.com/OPCLIA4 ). The practice will then receive an approval and fee coupon (ie, invoice) and need to pay the CLIA fee online. Once the certificate is received, testing may begin. Of note, COW sites may be chosen for a compliance survey, however this certification level is not routinely surveyed.

2. Code tests properly.

When performing CLIA-waived tests, make sure you code the test properly. An associated billing modifier, QW, must be attached to every claim that includes a CLIA-waived test CPT code, like so:

• 83861-QW: Microfluidic analysis utilizing an integrated collection and analysis device, tear osmolarity
• 83516-QW: Immunoassay for analyte other than infectious agent antibody or infectious agent antigen; qualitative or semiquantitative, multiple step method

The QW modifier lets the payer know a valid CLIA waiver is on file at the practice where the test was performed.

3. Remind the practice of CLIA recertification.

All CLIA certificates are valid for 2 years, then must be renewed. Failure to do so may result in a ban from the program and inability to test, as well as potential monetary fines for the practice, so it’s important to stay on top of the certificate’s expiration date.

Chipping in

By knowing the intricacies associated with your technician role, you can bring more value to the practice by helping to monitor the many moving parts of compliance.

Maintaining practice compliance is a team sport. While there is no “I” in team, there is a “me,” so don’t be afraid to chip in. OP

Ms. Brown is a senior consultant with BSM Consulting in Tucson, AZ. She has experience in the ophthalmic industry holding managerial, clinical, and surgical roles for more than 30 years.