{"id":9951,"date":"2025-03-01T14:01:39","date_gmt":"2025-03-01T19:01:39","guid":{"rendered":"https:\/\/dhss.delaware.gov\/dph\/clia\/"},"modified":"2025-03-02T00:41:09","modified_gmt":"2025-03-02T05:41:09","slug":"clia","status":"publish","type":"page","link":"https:\/\/dhss.delaware.gov\/dph\/lab\/clia\/","title":{"rendered":"lab\/clia ~  CLIA: Clinical Laboratory Improvement Amendments  &#8211; Delaware Health and Social Services &#8211; State of Delaware"},"content":{"rendered":"<div data-swiftype-index=\"true\">\n\n\n\n\n\n  <br>\n\n\n  \n\n\n  <div class=\"container\" id=\"main_header\">\n\n\n    <!-- BEGIN readspeaker div -->\n\n\n    <div class=\"rs_skip rsbtn rs_preserve\" id=\"readspeaker_button1\">\n\n\n      <a accesskey=\"L\" class=\"rsbtn_play\" href=\"https:\/\/app-na.readspeaker.com\/cgi-bin\/rsent?customerid=7262&#038;lang=en_us&#038;readid=main_content&#038;url=https:\/\/dhss.delaware.gov\/dph\/lab\/clia.html\" title=\"Listen to this page using ReadSpeaker\">\n\n\n        <span class=\"rsbtn_left rsimg rspart\"><span class=\"rsbtn_text\"><span>Listen<\/span><\/span><\/span>\n\n\n        <span class=\"rsbtn_right rsimg rsplay rspart\"><\/span>\n\n\n      <\/a>\n\n\n    <\/div>\n\n\n    <!-- END readspeaker div -->\n\n\n\n\n\n    \n\n\n    <header class=\"pull-left\">\n\n\n      <h1><!--[type=EDIT name=\"Page Title\"]-->Delaware Public Health Laboratory Accreditations and Certifications<!--[END]--><\/h1>\n\n\n    <\/header>\n\n\n  <\/div><br>\n\n\n \n\n\n  <div class=\"container\">\n\n\n    <div class=\"row\">\n\n\n      <div class=\"col-md-3\" id=\"leftCol\">\n\n\n        <div class=\"panel-group\" id=\"accordion\">\n\n\n          <div class=\"panel sectionmenu_panel\">\n\n\n            <div class=\"panel-heading\">\n\n\n              <p class=\"panel-title\"><a class=\"agency_nav\" data-parent=\"#accordion\" data-toggle=\"collapse\" href=\"#collapseOne\"><strong><i class=\"fa fa-align-justify fa-fw\"><\/i> Public Health Menu<\/strong><\/a><\/p>\n\n\n            <\/div>\n\n\n\n\n\n            <div class=\"panel-collapse collapse in\" id=\"collapseOne\">\n\n\n              <div class=\"panel-body\" id=\"clf_nav\">\n\n\n                  <ul class=\"nav nav-stacked nav-pills-clf\" id=\"agency_sidebar\">\n    <li><a href=\"\/dph\/\"><h2>Home <i class=\"fa fa-home fa-fw\"><\/i><\/h2><\/a><\/li>\n    <li class=\"toplevel\"><a data-parent=\"#agency_sidebar\" data-toggle=\"collapse\" href=\"#HomeMenu\"><h2>About <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n      <ul class=\"panel-collapse collapse\" id=\"HomeMenu\">\n        <li><a href=\"\/dph\/about.html\">About DPH<\/a><\/li>\n        <li><a href=\"\/dph\/sections.html\">Sections &#038; 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Conditions<\/a><\/li>\n        <li><a href=\"\/dph\/faq.html\">FAQ&#8217;s<\/a><\/li>\n        <li><a href=\"\/dph\/php\/alerts.html\">Health Alerts<\/a><\/li>\n        <li><a href=\"\/dph\/healthylifestyles.html\">Healthy Lifestyles<\/a><\/li>\n        <li><a href=\"\/dph\/hipaa.html\">HIPAA<\/a><\/li>\n        <li><a href=\"\/dph\/regs.html\">Regulations<\/a><\/li>\n        <li><a href=\"\/dph\/forms.html\">Request Forms<\/a><\/li>\n        <li><a href=\"\/dph\/links.html\">Links &#038; Resources<\/a><\/li>\n        <li><a href=\"http:\/\/delaware.gov\/help\/foia_request.shtml\">FOIA Request Form<\/a><\/li>\n      <\/ul>\n    <\/li>\n    <li><a id=\"SocialMenuHeader\"><h2>Connect <i class=\"fa fa-thumbs-o-up fa-fw\"><\/i><\/h2><\/a>\n      <ul id=\"SocialMenu\">\n        <li class=\"facebook\"><a href=\"https:\/\/www.facebook.com\/DEPublicHealth\" target=\"_blank\" title=\"Division of Public Health Facebook Page\"><i class=\"fa fa-facebook-square fa-lg\"><\/i> Facebook<\/a><\/li>\n        <li class=\"twitter\"><a href=\"https:\/\/twitter.com\/Delaware_DHSS\" target=\"_blank\" title=\"Delaware Health and Social Services Twitter Account\"><i class=\"fa fa-twitter-square fa-lg\"><\/i> Twitter<\/a><\/li>\n        <!-- <li class=\"googleplus\"><a href=\"#\"><i class=\"fa fa-google-plus-square fa-lg\"><\/i> Google +<\/a><\/li>\n        <li class=\"flickr\"><a href=\"#\"><i class=\"fa fa-flickr fa-lg\"><\/i> Flickr<\/a><\/li>\n        <li class=\"youtube\"><a href=\"#\"><i class=\"fa fa-youtube-square fa-lg\"><\/i> Youtube<\/a><\/li>\n        <li class=\"instagram\"><a href=\"#\"><i class=\"fa fa-instagram fa-lg\"><\/i> Instagram<\/a><\/li>\n        <li class=\"linkedin\"><a href=\"#\"><i class=\"fa fa-linkedin-square fa-lg\"><\/i> Linkedin<\/a><\/li>\n        <li class=\"pinterest\"><a href=\"#\"><i class=\"fa fa-pinterest-square fa-lg\"><\/i> Pinterest<\/a><\/li> -->\n      <\/ul>\n    <\/li>\n  <\/ul>\n\n\n              <\/div>\n\n\n            <\/div>\n\n\n          <\/div>\n\n\n        <\/div><br>\n\n\n      <\/div>\n\n\n\n\n\n      <div class=\"col-md-9\" id=\"main_content\"> \n\n\n  <!--[type=HTMLEDIT name=\"Content\"]-->\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<!-- Google Translate Element BEGIN -->\n\n\n\n\n<div id=\"google_translate_element\"><\/div>\n\n\n\n\n<script type=\"text\/javascript\">\n\n\n\n\n                    function googleTranslateElementInit() {\n\n\n\n\n                    new google.translate.TranslateElement({pageLanguage: 'en'}, 'google_translate_element');\n\n\n\n\n}\n\n\n\n\n                <\/script>\n\n\n\n\n                <script src=\"\/\/translate.google.com\/translate_a\/element.js?cb=googleTranslateElementInit\" type=\"text\/javascript\">\/**\/<\/script>\n\n\n\n\n<p>\u00a0<\/p>\n\n\n\n\n<!-- Google Translate Element END -->\n\n\n\n\n<p class=\"text-center\"><img decoding=\"async\" alt=\"Photos of Accreditation and Certification logos.\" class=\"img-thumbnail img-responsive\" src=\"\/wp-content\/uploads\/sites\/10\/dph\/img\/accredbanner.jpg\"><\/p>\n\n\n\n\n<h2>\n\n\n\n\n  Clinical Laboratory Improvement Amendments\n\n\n\n\n<\/h2>\n\n\n\n\n<p>\n\n\n\n\n  The Centers for Medicare &#038; Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U. S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.<\/p>\n\n\n\n\n<ul>\n\n\n\n\n<li><a href=\"\/wp-content\/uploads\/sites\/10\/dph\/pdf\/CLIAcert2325.pdf\">DPHL CLIA Certification<\/a><\/li>\n\n\n\n\n<li>Email the completed<a href=\"\/wp-content\/uploads\/sites\/10\/dph\/pdf\/cliaapp.pdf\"> CLIA Application<\/a> to CLIA.delaware@delaware.gov or mail to <a href=\"\/main\/maps\/labs\/dphlab.htm\">DPH Laboratory.<\/a><\/li>\n\n\n\n\n<li>Visit the <a href=\"http:\/\/www.cms.gov\/clia\">CLIA website<\/a> for more information.\n\n\n\n\n  <\/li>\n\n\n\n\n<li>Visit the <a href=\"cliafaqs.html\">CLIA FAQs<\/a> page\n\n\n\n\n  <\/li>\n\n\n\n\n<li><a href=\"\/wp-content\/uploads\/sites\/10\/dph\/pdf\/cliaptrequirements.pdf\">CLIA PT Requirements<\/a><\/li>\n\n\n\n\n<li><a href=\"\/wp-content\/uploads\/sites\/10\/dph\/pdf\/sop-complaints.pdf\">DPH Laboratory Procedure for Complaints<\/a><\/li>\n\n\n\n\n<li><a href=\"\/wp-content\/uploads\/sites\/10\/dph\/pdf\/complaintsinvestigation.pdf\">DPH Laboratory Complaint Investigation Form<\/a><\/li>\n\n\n\n\n<\/ul>\n\n\n\n\n<p>\u00a0<\/p>\n\n\n\n\n<h2>\n\n\n\n\n  Environmental Protection Agency and Certification Program\n\n\n\n\n<\/h2>\n\n\n\n\n<p>\n\n\n\n\n The Environmental Protection Agency (EPA) regulates laboratories that analyze drinking water from public water systems. In protecting public health the EPA identifies contaminants regulated in drinking water. Public water systems provide water samples to be analyzed and the EPA sets regulatory limits for certain contaminants, including chemical and bacteriological. These contaminant standards are required by the <a href=\"https:\/\/www.epa.gov\/dwstandardsregulations\/background-drinking-water-standards-safe-drinking-water-act-sdwa\">Safe Drinking Water Act (SDWA)<\/a>. EPA works with states, tribes, and many other partners to implement these SDWA provisions. In order for the State of Delaware to maintain primacy with EPA as per the SDWA, the State of Delaware needs a laboratory certification program. One of the provisions of the laboratory certification program is that each certified drinking water laboratory must be inspected on a triennial basis. The personnel responsible for laboratory inspections are Laboratory Certification Officers (CO).  In order to become certified as a CO, Environmental Laboratory staff must attend and pass the EPA Laboratory Certification Officers course provided by the EPA. To inspect a laboratory which analyzes drinking water for inorganic and\/or organic chemistry and\/or microbiology, a CO must be certified. Typically the CO performs inspections, writes reports, and makes recommendations regarding certification status of the laboratory to the Certifying Authority.  All of the certification officers in Delaware function as full time employees within the laboratory. For laboratories operating in Delaware other than DPH, complaints may be directed to CLIA.delaware@delaware.gov.<\/p>\n\n\n\n\n<ul>\n\n\n\n\n<li>\n\n\n\n\n    <a href=\"\/wp-content\/uploads\/sites\/10\/dph\/pdf\/EPAcert24.pdf\">DPHL EPA Certification<\/a> \n\n\n\n\n  <\/li>\n\n\n\n\n<li>Visit the <a href=\"https:\/\/www.epa.gov\/dwstandardsregulations\">EPA website<\/a> for more information.\n\n\n\n\n  <\/li>\n\n\n\n\n<li>Learn About <a href=\"https:\/\/www.epa.gov\/dwlabcert\/learn-about-laboratory-certification-drinking-water\">Drinking Water Laboratory Certification<\/a>.\n\n\n\n\n  <\/li>\n\n\n\n\n<li>Contact the <a href=\"http:\/\/www.dhss.delaware.gov\/dph\/contact.html#odw\">Office of Drinking Water<\/a> for Questions Regarding Laboratory Certification.\n\n\n\n\n  <\/li>\n\n\n\n\n<li><a href=\"https:\/\/www.epa.gov\/dwlabcert\">EPA Certification of Laboratories that Analyze Drinking Water Samples to Ensure Compliance with Regulations<\/a>.\n\n\n\n\n  <\/li>\n\n\n\n\n<li><a href=\"https:\/\/www.epa.gov\/dwlabcert\/laboratory-certification-manual-drinking-water\">EPA Laboratory Certification Manual for Drinking Water<\/a>.\n\n\n\n\n  <\/li>\n\n\n\n\n<\/ul>\n\n\n\n\n<p>\u00a0<\/p>\n\n\n\n\n<h2>\n\n\n\n\n  Food and Drug Administration Milk Safety Program\n\n\n\n\n<\/h2>\n\n\n\n\n<p>\n\n\n\n\nThe DPH Laboratory works with the Health Systems Protection\u2019s Office of Food Protection, to ensure the public\u2019s health by establishing minimum standards for those involved with the processing, transport and sale of milk and milk products in Delaware. To protect the health of Delawareans, the program conducts inspections, issues permits, and enforces the State of Delaware Milk Code. \n\n\n\n\n<\/p>\n\n\n\n\n<p>\n\n\n\n\nThe Food and Drug Administration (FDA) certified Laboratory Evaluation Officer (LEO) at DPHL performs annual evaluations of the dairy processing plants located in the state to ensure they meet the Drug Residue Testing responsibilities (Appendix N) of the current in use edition of the Grade &#8220;A&#8221; Pasteurized Milk Ordinance (PMO).\n\n\n\n\n<\/p>\n\n\n\n\n<ul>\n\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/Food\/GuidanceRegulation\/FederalStateFoodPrograms\/default.htm\">Information regarding the FDA oversight of milk safety<\/a>.\n\n\n\n\n  <\/li>\n\n\n\n\n<li><a href=\"http:\/\/www.dhss.delaware.gov\/dph\/hsp\/ofpmilk.html\">Information regarding the DPH oversight of milk processing<\/a>.\n\n\n\n\n  <\/li>\n\n\n\n\n<\/ul>\n\n\n\n\n<p>\n\n\n\n\n  Return to the <a href=\"labs.html\">Delaware Public Health Laboratory home page<\/a>.\n\n\n\n\n<\/p>\n\n\n\n\n<p>\n\n\n\n\n<br>\n\n\n\n\n<br><\/p>\n\n\n\n\n<p class=\"smalltext\"><a href=\"http:\/\/www.adobe.com\/products\/acrobat\/readstep2.html\"><img loading=\"lazy\" decoding=\"async\" alt=\"Download Adobe Acrobat Reader\" height=\"21\" src=\"\/wp-content\/uploads\/dhss\/img\/getacro60.gif\" width=\"60\"><\/a> Please note: Some of the files available on this page are in Adobe PDF format which requires Adobe Acrobat Reader.  A free copy of Adobe Acrobat Reader can be downloaded directly from <a href=\"http:\/\/www.adobe.com\/products\/acrobat\/readstep2.html\">Adobe <\/a>. If you are using an assistive technology unable to read Adobe PDF, please either view the corresponding text only version (if available) or visit Adobe&#8217;s <a href=\"http:\/\/access.adobe.com\">Accessibility Tools page<\/a>.<\/p>\n\n\n\n\n\n  <!--[END]-->\n\n\n  \n\n\n      <\/div>\n\n\n    <\/div>\n\n\n  <\/div><!-- \/container -->\n\n\n<\/div>","protected":false},"excerpt":{"rendered":"<p>Listen Delaware Public Health Laboratory Accreditations and Certifications Public Health Menu Home About About DPH Sections &#038; Programs Office Locations Contact Info Calendar Services A-Z Services Air &#038; Water Quality Birth, Death, &#038; Marriage Records Clinics Health Data &#038; Statistics Emergency Preparedness Health &#038; Wellness Healthy Homes Healthy Workplaces Laboratory Restaurant Inspections Screening and Testing [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":9943,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-9951","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9951","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/comments?post=9951"}],"version-history":[{"count":1,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9951\/revisions"}],"predecessor-version":[{"id":11144,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9951\/revisions\/11144"}],"up":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9943"}],"wp:attachment":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/media?parent=9951"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}