Office Testing Adds a CLIA Question to Midwifery Care

Rachael Lara

Oct 12

2 min read

Identify who actually performs the test

A midwifery practice collects a specimen for an outside laboratory and later decides to perform some testing in the office. That change deserves review before the first patient result is reported.

CMS explains that facilities testing human specimens for health assessment or to diagnose, prevent, or treat disease generally need a CLIA certificate. Facilities that only collect or prepare specimens, or act as a mailing service, are not considered laboratories under that guidance. The distinction is between collecting a specimen and performing the testing. [1]

An office test can create laboratory obligations even when it feels like a small addition to a prenatal appointment.

Check the exact test and certificate

List each testing system the practice intends to use and verify its complexity classification. Do not assume every rapid or point-of-care test is waived. CMS's certificate guidance distinguishes waived testing from other testing categories, and its laboratory director guidance requires appropriate training and following manufacturers' instructions for waived testing. [2, 3]

Confirm which certificate is needed for the testing site and who is responsible for the laboratory's operation. Review state requirements as well as CLIA. A professional credential and a laboratory certificate answer different questions.

For midwifery practices, the clinician's actual credential and state authority still matter. Certified nurse-midwives, certified midwives, and certified professional midwives should not be treated as interchangeable when deciding who may order, perform, or interpret a service. Obtain requirements for the clinician and location involved.

Build the testing and billing workflow together

Record who ordered the test, why it was needed, where it was performed, the result, and how the result was addressed. Retain the operational records required for the testing arrangement. Assign responsibility for supplies, expiration checks, and manufacturer instructions.

Before billing, confirm the code for the actual test and the payer's laboratory claim requirements, including certificate information or modifiers where applicable. The existence of a clinical office contract does not establish every laboratory payment route.

For example, if the practice only collects a specimen and another laboratory performs the analysis, do not submit the laboratory's testing as though the practice performed it. Explain to the patient which organization will produce the result and may issue a bill.

At Sunshyn, we want added services to come with clear responsibilities. Decide whether the practice is collecting, testing, or both, then establish the appropriate certificate, documentation, and claim process before offering the service.