<html>
<head>
<meta http-equiv="Content-Type" content="text/html; charset=Windows-1252">
<style type="text/css" style="display:none;"> P {margin-top:0;margin-bottom:0;} </style>
</head>
<body dir="ltr">
<div style="font-family: Cambria, Georgia, serif; font-size: 12pt; color: rgb(0, 0, 0);" class="elementToProof">
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
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. </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<br class="ContentPasted0">
</p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
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. </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<br class="ContentPasted0">
</p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
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. </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<br class="ContentPasted0">
</p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
To renew a CLIA certificate, you may complete the<span style="margin:0px" class="ContentPasted0"> </span><a href="https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable" data-linkindex="0" style="font-weight: normal; margin: 0px; text-decoration: underline; color: rgb(51, 102, 153);" class="ContentPasted0">CMS116</a><span style="margin:0px" class="ContentPasted0"> </span>form
and email it to:<span style="margin:0px" class="ContentPasted0"> </span>CliaLab.DHHS@maine.gov </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<br class="ContentPasted0">
</p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
If at any time your school adds tests beyond what were listed originally, an updated<span style="margin:0px" class="ContentPasted0"> </span><a href="https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable" data-linkindex="1" style="font-weight: normal; margin: 0px; text-decoration: underline; color: rgb(51, 102, 153);" class="ContentPasted0">CMS116</a><span style="margin:0px" class="ContentPasted0"> </span>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. </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<strong><br class="ContentPasted0">
</strong></p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<strong class="ContentPasted0">Resources </strong></p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
<a href="https://www.cms.gov/files/document/cms-clia-laboratory-quick-start-guide-remediated.pdf" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable" data-linkindex="2" style="font-weight: normal; margin: 0px; text-decoration: underline; color: rgb(51, 102, 153);" class="ContentPasted0">Quick
Start Guide for CLIA</a> </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
<a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCertificateofWaiver.pdf" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable" data-linkindex="3" style="font-weight: normal; margin: 0px; text-decoration: underline; color: rgb(51, 102, 153);" class="ContentPasted0">How
to Apply Booklet</a> </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
<a href="https://www.cdc.gov/clia/docs/waived-tests/ready-set-test-booklet.pdf" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable" data-linkindex="4" style="font-weight: normal; margin: 0px; text-decoration: underline; color: rgb(51, 102, 153);" class="ContentPasted0">Ready,
Set, Test Booklet</a><span style="margin:0px" class="ContentPasted0"> </span>A detailed booklet on maintaining a CLIA certificate of waiver </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
<a href="https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf" target="_blank" rel="noopener noreferrer" data-auth="NotApplicable" data-linkindex="5" style="font-weight: normal; margin: 0px; text-decoration: underline; color: rgb(51, 102, 153);" class="ContentPasted0">CMS116
Form</a> </p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;">
<strong><br class="ContentPasted0">
</strong></p>
<p style="font-size: 14px; font-family: Arial; text-align: left; margin-top: 0px; margin-bottom: 0px; color: rgb(80, 80, 80); background-color: white;" class="ContentPasted0">
<strong class="ContentPasted0">State of Maine CLIA Contact </strong><br class="ContentPasted0">
Division of Licensing & Certification <br class="ContentPasted0">
41 Anthony Avenue, Station #11, Augusta, ME 04333-0011 <br class="ContentPasted0">
(207) 287-9339 <br class="ContentPasted0">
Email:<span style="margin:0px" class="ContentPasted0"> </span>CliaLab.DHHS@maine.gov <br class="ContentPasted0">
</p>
<br>
</div>
<div class="elementToProof">
<div style="font-family: Cambria, Georgia, serif; font-size: 12pt; color: rgb(0, 0, 0);">
<br>
</div>
<div id="Signature">
<div>
<div style="font-family: Cambria, Georgia, serif; font-size: 12pt; color: rgb(0, 0, 0);">
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<a style="margin:0px"><i><span style="font-family:Cambria, serif;margin:0px">Emily Poland</span></i></a><span style="font-family:Cambria, serif;margin:0px">, MPH, RN, NCSN <span style="font-size: 10pt; font-family: "Palatino Linotype", "Book Antiqua", Palatino, serif; margin: 0px; background-color: white;">she/her/hers</span></span></p>
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<span style="font-family:Cambria, serif;margin:0px"></span></p>
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<span style="font-size:8pt;font-family:Cambria, serif;margin:0px">School Nurse Consultant</span></p>
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<span style="font-size:8pt;font-family:Cambria, serif;margin:0px">Team Leader, Coordinated School Health</span></p>
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<span style="font-size:8pt;font-family:Cambria, serif;margin:0px">Maine Department of Education</span></p>
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<span style="font-size:8pt;font-family:Cambria, serif;margin:0px">Phone: (207) 592-0387<br>
<font face="Arial Black, Arial, sans-serif"><span style="font-size: 13.3333px; background-color: rgb(255, 255, 255);"><a href="https://www.maine.gov/doe/schools/safeschools/healthed/nurseresources/guidelines" title="https://www.maine.gov/doe/schools/safeschools/healthed/nurseresources/guidelines">Guidelines
for School Health Services</a></span></font><br>
</span></p>
<p style="font-family: Calibri, Helvetica, sans-serif; text-align: start; margin-top: 0px; margin-bottom: 0px; background-color: rgb(255, 255, 255);">
<br>
</p>
</div>
</div>
</div>
</div>
</body>
</html>