Health: Consumer Services & Health Care Regulation: Clinical Laboratory (CLIA) Licensing and Certification Program

<!doctype html> <html class="no-js" lang="en" aria-label="Consumer Services & Health Care Regulation - Clinical Laboratory (CLIA) Licensing and Certification Program" data=" subpage "> <head>  <title>Health: Consumer Services & Health Care Regulation: Clinical Laboratory (CLIA) Licensing and Certification Program</title> <meta charset="utf-8"> <meta name="description" content="" /> <meta name="keywords" content="" /> <meta name="viewport" content="width=device-width, initial-scale=1.0"> <meta name="apple-mobile-web-app-capable" content="yes"> <meta http-equiv="X-UA-Compatible" content="IE=edge,chrome=1"> <meta name="dcterms.title" content="Clinical Laboratory (CLIA) Licensing and Certification Program"> <meta name="dcterms.creator" content="Consumer Services & Health Care Regulation"> <meta name="dcterms.created" content="2021-04-06T08:12:26-04:00"> <meta name="dcterms.modified" content="2023-09-21T09:17:48-04:00"> <meta name="dcterms.issued" content="2021-04-14T16:33:46-04:00"> <meta name="dcterms.format" content="HTML"> <meta name="dcterms.identifier" content="https://www.in.gov/health/cshcr/acute-and-continuing-care/clinical-laboratory-clia-licensing-and-certification-program">   <meta name="assetType" content="page_standard" /> <meta name="assetName" content="Clinical Laboratory (CLIA) Licensing and Certification Program" />  <meta itemprop="name" content="Clinical Laboratory (CLIA) Licensing and Certification Program" /> <meta itemprop="description" content="" /> <meta itemprop="image" content="" /> <meta name="twitter:card" content="summary" /> <meta name="twitter:title" content="Clinical Laboratory (CLIA) Licensing and Certification Program" /> <meta name="twitter:description" content="" /> <meta property="og:title" content="Clinical Laboratory (CLIA) Licensing and Certification Program" /> <meta property="og:description" content="" /> <meta property="og:type" content="website" /> <meta property="og:url" content="https://www.in.gov/health/cshcr/acute-and-continuing-care/clinical-laboratory-clia-licensing-and-certification-program/" /> <meta property="og:site_name" content="Consumer Services & Health Care Regulation" /> <meta property="article:published_time" content="2021-04-14T16:33:46-04:00" /> <meta property="article:modified_time" content="2023-09-21T09:17:48-04:00" /> <meta property="article:tag" content="" /> <link rel="shortcut icon" href="/global/images/favicon.ico" /> <link rel="preconnect" href="https://fonts.googleapis.com"> <link rel="preconnect" href="https://fonts.gstatic.com" crossorigin> <link href="https://fonts.googleapis.com/css2?family=Kanit:ital,wght@0,300;0,400;0,600;0,700;1,300;1,400;1,600;1,700&family=Rethink+Sans:ital,wght@0,400..800;1,400..800&display=swap" rel="stylesheet"> <link type="text/css" rel="stylesheet" media="all" href="/global/css/font-awesome-6.4.2/css/all.css" /> <link type="text/css" rel="stylesheet" media="all" href="/global/css/agency-styles-2024.css" /> <script type="text/javascript" src="/global/javascript/jquery-3.5.1.js"></script>  <link href="/health/includes/custom.css" rel="stylesheet"> <link href="/health/includes/custom.css" rel="stylesheet"> <link href="/health/cshcr/includes/custom.css" rel="stylesheet"> <link href="/health/cshcr/includes/colors_2024.css" rel="stylesheet"> </head> <body id="subpage" class="idoh info show-horizontal-menu "> <header data-sticky-container class=""> <div data-sticky data-margin-top="0" data-sticky-on="small"> <div id="header_sliver" class="row expanded"> <div id="header_sliver_logo_container" class="container_ingovlogo columns"> <a id="header_sliver_logo_link" href="https://www.in.gov/" target="_blank"> <svg id="in-gov-logo-svg" class="in-gov-logo-svg" alrt="IN.gov Logo" data-name="IN.gov Logo" xmlns="http://www.w3.org/2000/svg" viewBox="0 0 120 32.26" height="18" width="68"> <defs> <style> .ingov-logo { fill: #fff; 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In total, CLIA covers approximately 189,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.</p><p>The Indiana Department of Health (IDOH) inspects laboratories for compliance with the standards and specific requirements with CLIA. IDOH surveyors visit laboratories bi-annually for certificate of compliance or more often if complaints are filed about a laboratory.</p><p><a href="/health/cshcr/acute-and-continuing-care/clinical-laboratory-clia-licensing-and-certification-program/clia-frequently-asked-questions">Frequently Asked Questions</a></p> </section> <section id="content_container_623635"> <h3>Report a Complaint or Incident</h3><p><a href="/health/ltc/contact/complaints">Report a complaint regarding a health care facility</a><br /> Individuals can call or email to make complaints about care provided at any licensed or certified Indiana health care providers or suppliers.</p><p><a href="/health/ltc/incident">Report an incident regarding a health care facility</a><br /> The Incident Report Form is for health care facilities to notify the Indiana Department of Health of a reportable incident pursuant to the IDOH Reportable Unusual Occurrence Policy. The Incident Report Form is also for health care facility staff (nursing homes, intermediate care facilities, and hospice agencies) to report a reasonable suspicion of a crime against a resident pursuant to Federal regulations. This form is not to be used to file a complaint.</p> </section> <section id="content_container_393833"> <h3>Consumer Information</h3><p><a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html">Centers for Medicare and Medicaid Services/CLIA</a></p><p><a href="/health/cshcr/indiana-health-care-quality-resource-center/advance-directives-resource-center">Advance Directives Resource Center</a></p> </section> <section id="content_container_623637"> <h3>Program Information and Policies</h3><p><a href="http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html">State Operations Manual</a></p><h4>Forms</h4><p>All forms (CMS 116 CLIA Application, Enclosure A Disclosure of Ownership and Enclosure I Methodology Test list) must be completed and signed and appropriate documentation attached for initial certificates and most changes of certificate type.</p><p>The CMS 116 CLIA Application and Enclosure A Disclosure of Ownership are completed for change of ownership and Tax ID.</p><p>The CMS 116 CLIA Applications may be completed for any changes.</p><p><a href="http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf">CMS 116 CLIA Application</a></p><p><a href="/health/files/Enclosure_A_Ownership_Disclosure.pdf">Enclosure A Disclosure of Ownership</a></p><p><a href="/health/files/Enclosure_I_Methodology_Form.pdf">Enclosure I Methodology Test List</a></p> </section> <section id="content_container_623632"> <h3>Contact</h3><table style="width: 100%;" class="stack"><tbody><tr><td><strong> Indiana Department of Health</strong><br />Division of Acute Care<br />2 North Meridian Street, 4A<br />Indianapolis, IN 46204 </td><td><p><strong>Program Manager</strong><br />Lorraine Switzer<br /><a href="mailto:lswitzer@health.in.gov">lswitzer@health.in.gov</a></p></td></tr><tr><td> IDOH Main Switchboard: 317-233-1325<br />Acute Care Receptionist: 317-233-7474 </td><td> 317-233-7502<br />Administrative Assistant: 317-233-7495 </td></tr></tbody></table><h4>Directories</h4><p><a href="https://qcor.cms.gov/main.jsp">Directory of CLIA Laboratories</a></p> </section>  <section class="accordion-container " data-ctype="accordion" style="background-color: ;"> <section id="content_container_620172"> <h3>Laws and Regulations</h3> </section> <ul class="accordion " data-accordion data-deep-link="true" data-deep-link-smudge="true" data-deep-link-smudge-delay="200" data-deep-link-smudge-offset="50" data-allow-all-closed="true" data-multi-expand="true" style="display:flex; flex-direction:column;" >  <li style="order:1" class="accordion-item orderFirst" data-accordion-item> <a href="#Federal_Laws_and_Regulations" class="accordion-title"> Federal Laws and Regulations </a> <div class="accordion-content" data-tab-content id="Federal_Laws_and_Regulations"> <p><a href="https://www.gpo.gov/fdsys/granule/CFR-2011-title42-vol5/CFR-2011-title42-vol5-part493/content-detail.html">42 CFR 493 (Laboratory requirements)</a></p><p><a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/App-C_Survey-Procedures-IGs-for-Labs-Labs-Svcs-Final.pdf">State Operations Manual Appendix C</a></p><p><a href="https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR">Code of Federal Regulations (CFR) Homepage</a></p> </div> </li>  <li style="order:2" class="accordion-item orderLast" data-accordion-item> <a href="#State_Laws_and_Rules" class="accordion-title"> State Laws and Rules </a> <div class="accordion-content" data-tab-content id="State_Laws_and_Rules"> <p><a href="http://iga.in.gov/legislative/laws/2022/ic/titles/016/#16-41-12">Indiana Code 16-41-12</a></p><p><a href="http://www.in.gov/legislative/ic_iac/">Indiana Law and Rules Homepage</a></p><p><a href="http://iac.iga.in.gov/iac//irtoc.htm">Indiana Register</a></p><p><a href="https://secure.in.gov/apps/isp/lch/">Limited Criminal History Search</a></p> </div> </li> </ul> </section> <section 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