[MaineSchoolNurse] Clinical Laboratory Improvement Amendment (CLIA) Waivers in Maine Schools

[Poland, Emily]

One of the lessons learned during COVID-19 testing in schools was the need for schools doing a variety of biological or clinical testing to have a Clinical Laboratory Improvement Amendment  CLIA Waiver on file. This was brought to light due to the COVID-19 testing and reporting that occurred at schools during the height of the pandemic. All facilities, including schools, are required to maintain a CLIA certificate if they are performing any clinical testing. The Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA) regulates the quality and safety of U.S. clinical laboratories to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.


CLIA requires all entities that perform even one test using a student’s own equipment on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program. A CLIA Certificate of Waiver is a certification that allows a facility, primarily laboratories, to legally examine a person through waived tests in order to assess health, diagnose, and determine treatment.


The most commonly used tests in a school setting are blood glucose analysis and ketones in urine. The results of these tests are used to determine treatment for a person with diabetes. The results and treatment are documented within the student’s student health record.


To renew a CLIA certificate, you may complete the CMS116<https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf> form and email it to: CliaLab.DHHS at maine.gov


If at any time your school adds tests beyond what were listed originally, an updated CMS116<https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf> needs to be re-submitted. Schools are encouraged to save the original completed form electronically so that adjustments can be made with ease as needed. There is a 30-day grace period that allows additional testing while filing an updated CLIA form if you need to add a different test to perform in your setting.  CMS mails a bill (currently $180 every 2 years) approximately 6 months prior to expiration; once paid, a new certificate will be generated 3 weeks prior to expiration of the old certificate.


Resources

Quick Start Guide for CLIA<https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf>

How to Apply Booklet<https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf>

Ready, Set, Test Booklet<https://www.cdc.gov/clia/docs/waived-tests/ready-set-test-booklet.pdf> A detailed booklet on maintaining a CLIA certificate of waiver

CMS116 Form<https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf>


State of Maine CLIA Contact
Division of Licensing & Certification
41 Anthony Avenue, Station #11, Augusta, ME 04333-0011
(207) 287-9339
Email: CliaLab.DHHS at maine.gov




Emily Poland, MPH, RN, NCSN she/her/hers

School Nurse Consultant

Team Leader, Coordinated School Health

Maine Department of Education

Phone: (207) 592-0387
Guidelines for School Health Services<https://www.maine.gov/doe/schools/safeschools/healthed/nurseresources/guidelines>

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://maillist.informe.org/pipermail/maineschoolnurse/attachments/20230517/50f00184/attachment.htm>