Health: Consumer Services & Health Care Regulation: Blood Center Licensing and Certification Program

<!doctype html> <html class="no-js" lang="en" aria-label="Consumer Services & Health Care Regulation - Blood Center Licensing and Certification Program " data=" subpage "> <head>  <title>Health: Consumer Services & Health Care Regulation: Blood Center 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="Blood Center Licensing and Certification Program "> <meta name="dcterms.creator" content="Consumer Services & Health Care Regulation"> <meta name="dcterms.created" content="2021-04-06T08:11:31-04:00"> <meta name="dcterms.modified" content="2023-09-21T09:14:51-04:00"> <meta name="dcterms.issued" content="2021-04-14T16:33:44-04:00"> <meta name="dcterms.format" content="HTML"> <meta name="dcterms.identifier" content="https://www.in.gov/health/cshcr/acute-and-continuing-care/blood-center-licensing-and-certification-program">   <meta name="assetType" content="page_standard" /> <meta name="assetName" content="Blood Center Licensing and Certification Program " />  <meta itemprop="name" content="Blood Center Licensing and Certification Program " /> <meta itemprop="description" content="" /> <meta itemprop="image" content="" /> <meta name="twitter:card" content="summary" /> <meta name="twitter:title" content="Blood Center Licensing and Certification Program " /> <meta name="twitter:description" content="" /> <meta property="og:title" content="Blood Center 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/blood-center-licensing-and-certification-program/" /> <meta property="og:site_name" content="Consumer Services & Health Care Regulation" /> <meta property="article:published_time" content="2021-04-14T16:33:44-04:00" /> <meta property="article:modified_time" content="2023-09-21T09:14:51-04:00" /> <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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Any facility that meets the definition of a blood center prescribed in Indiana Code 16-41-12-3 must be licensed by the Indiana Department of Health (IDOH) on an annual basis. A blood center must also be registered or licensed by the United States Food and Drug Administration and comply with all applicable federal regulations. <br /><br />The IDOH monitors the health care quality of blood centers through the licensure process. IDOH surveyors visit centers annually for licensure inspections or more often if complaints are filed about a center.</p> </section> <section id="content_container_393823"> <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 class="icon-buckets-wrap " id="icon-buckets-620225" data-ctype="icon-buckets" > <div class="row expanded align-center"> <div class="columns large-expand medium-6 small-12 " data-aos="fade" data-aos-anchor="#icon-buckets-620225">  <div class="icon-bucket-content"> <div class="icon"> <span class="fas fa-question-circle"></span> </div> <h3>Consumer Information</h3> <ul><li><a href="https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html">Centers for Medicare and Medicaid Services/CLIA</a></li><li><a href="/health/cshcr/indiana-health-care-quality-resource-center/advance-directives-resource-center">Advance Directives Resource Center</a></li><li><a href="/health/reports/QAMIS/bcdir/index.htm">Directory of Blood Centers</a></li></ul> </div> </div> <div class="columns large-expand medium-6 small-12 " data-aos="fade" data-aos-anchor="#icon-buckets-620225"> <div class="icon-bucket-content"> <div class="icon"> <span class="fas fa-question-circle"></span> </div> <h3>Advisory Letters</h3> <ul><li><a href="/health/files/AC_2012-09-10_Blood_Centers_HCTP.pdf">AC 2012-01 Blood Centers</a> Testing of Blood/Blood Products and Human Cells, Tissues,<br /> and Cellular and Tissue-Based Products (HCT/Ps)</li></ul> </div> </div> <div class="columns large-expand medium-6 small-12 " data-aos="fade" data-aos-anchor="#icon-buckets-620225"> <div class="icon-bucket-content"> <div class="icon"> <span class="fas fa-question-circle"></span> </div> <h3>Forms</h3> <ul><li><a href="https://forms.in.gov/Download.aspx?id=5624">Application for License to Operate a Blood Center</a></li><li><a href="https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/index.html">Centers of Medicare and Medicaid Services Forms</a></li></ul> </div> </div> </div> </section> <section id="content_container_620215"> <h3>Contact the Program</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> </section>  <section class="accordion-container " data-ctype="accordion" style="background-color: ;"> <section id="content_container_620212"> <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.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Interpretive_Guidelines_for_Laboratories.html">Clinical Laboratory Improvement Act (CLIA) Requirements</a></p><p><a href="http://www.ecfr.gov/cgi-bin/ECFR?page=browse">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="https://iga.in.gov/laws/2022/ic/titles/16#16-41-12">Indiana Code 16-41-12</a></p><p><a href="/health/files/ARTICLE-1.-COMMUNICABLE-DISEASE-CONTROL.pdf">410 IAC 1: Indiana Communicable Disease Reporting Rule</a></p><p><a href="http://www.in.gov/legislative/ic_iac/">Indiana Law and Rules Homepage</a></p><p><a href="http://www.in.gov/legislative/register/index-29.html">Indiana Register</a></p><p><a href="/health/files/ARTICLE-1.-COMMUNICABLE-DISEASE-CONTROL.pdf">410 IAC 1-4: Indiana Universal Precautions Rule</a></p><p><a href="https://secure.in.gov/apps/isp/lch/">Limited Criminal History Search</a></p> </div> </li> </ul> </section> <section class="accordion-container " data-ctype="accordion" style="background-color: ;"> <section id="content_container_620210"> <h3>Links</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="#Professional_Organizations" class="accordion-title"> Professional Organizations </a> <div class="accordion-content" data-tab-content id="Professional_Organizations"> <p><a href="http://www.aabb.org/Pages/default.aspx">AABB (formerly the American Association of Blood Banks)</a></p><p><a href="http://www.ahima.org/">American Health Information Management Association</a></p><p><a href="https://apic.org/" target="_blank">Association of Professionals in Infection Control and Epidemiology</a></p><p><a href="http://indianadonornetwork.org/">Indiana Donor Network</a></p><p><a href="http://www.clma.org/">Clinical Laboratory Management Association</a></p><p><a href="http://www.ascls.org/">American Society for Clinical Laboratory Science</a><br /><br /><a href="http://www.ascp.org/">American Society for Clinical Pathologists</a></p> </div> </li>  <li style="order:2" class="accordion-item " data-accordion-item> <a href="#State_Government" class="accordion-title"> State Government </a> <div class="accordion-content" data-tab-content id="State_Government"> <p><a href="http://www.in.gov/pac/">Indiana Public Access 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