Clinical Laboratory Improvement Amendments (CLIA)

Clinical Laboratory Improvement Amendments (CLIA)

Clinical Laboratory Improvement Amendments (CLIA)

All midwives need to think about CLIA. It is very important to follow the rules if you are doing urine dipsticks for prenatal visits, lab draws on site versus sending to local resources, doing finger sticks for random glucose levels in office, or performing wet mounts to rule out bacterial vaginosis. All of those lab tests are regulated through the Clinical Laboratory Improvement Amendments (CLIA). CLIA requires that any facility examining human specimens for diagnosis, prevention, treatment of a disease or for assessment of health must register with the federal Centers for Medicare & Medicaid Services (CMS) and obtain CLIA certification

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing. 

There are federal guidelines, but each state has more specific rules and forms to complete. Please refer to your state Health Department for further instructions. CLIA does refer more to CNMs, but I do recommend Direct Entry Midwives and CPMs to double check their states laws to make sure that they are being compliant. Last thing any midwife business wants to do is have fines or violations on the state’s radar.