The federal Centers for Medicaid and Medicare Services (CMS) regulates laboratory testing through the Clinical Laboratory Improvement Amendments (CLIA) certification program. The objective of CLIA is to ensure the accuracy, reliability and timeliness of patient test results through laboratory standards.
Any person or facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. This also includes CLIA-waived tests (simple tests with a low risk for an incorrect result, such as finger-stick blood sugars and urine dipstick tests for glucose or ketones).
Different types of CLIA certificates are available, depending on what type of testing is performed at the facility. Most school nurse offices will fall under a CLIA waiver certificate.
In Kentucky, the certificate of waiver has a multiple location exemption that saves the local board of education the cost of applying for individual CLIA certificates. The school district applies for the certificate using the board of education as the home address. It also must list each school that the school nurse services (schools qualify as a temporary testing site). The school district can list up to 200 schools per waiver for the district.
Certificates are $180 each and last for two years. District health coordinators are encouraged to keep a copy of the CLIA certificate on file at each school nurse’s office. Visit CMS’ website for an application for a CLIA certificate.
If you are unsure whether your district has a current CLIA certificate or if you need more information, email Truman Taylor or call him at (859) 285-4457.