{"id":10408,"date":"2025-03-01T14:07:57","date_gmt":"2025-03-01T19:07:57","guid":{"rendered":"https:\/\/dhss.delaware.gov\/dph\/dhan436\/"},"modified":"2025-03-02T00:55:07","modified_gmt":"2025-03-02T05:55:07","slug":"dhan436","status":"publish","type":"page","link":"https:\/\/dhss.delaware.gov\/dph\/php\/alerts\/dhan436\/","title":{"rendered":"php\/alerts\/dhan436 ~  Division of Public Health &#8211; Health Advisory  &#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\/php\/alerts\/dhan436.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>Delaware Health Alert Network #<!--[type=EDIT name=\"DHAN Number\"]-->436 <!--[END]--> <\/h1>\n\n\n      <h2> <!--[type=EDIT name=\"DHAN Date\"]-->October 1, 2020 10:15 am <!--[END]--> <\/h2>\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; Programs<\/a><\/li>\n        <li><a href=\"\/dph\/ofclocations.html\">Office Locations<\/a><\/li>\n        <li><a href=\"\/dph\/contact.html\">Contact Info<\/a><\/li>\n      \n        <li><a href=\"\/calendars.html\" target=\"_blank\">Calendar<\/a><\/li>\n      <\/ul>\n    <\/li>\n    <li class=\"toplevel\"><a data-parent=\"#sidebar\" data-toggle=\"collapse\" href=\"#ServicesMenu\"><h2>Services <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n      <ul class=\"panel-collapse collapse\" id=\"ServicesMenu\">\n        <li><a href=\"\/dph\/servicesaz.html\">A-Z Services<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/environmental.html\">Air &#038; Water Quality<\/a><\/li>\n        <li><a href=\"\/dph\/ss\/vitalstats.html\">Birth, Death, &#038; Marriage Records<\/a><\/li>\n        <li><a href=\"\/dph\/clinics.html\">Clinics<\/a><\/li>\n        <li><a href=\"\/dph\/healthdatastats.html\">Health Data &#038; Statistics<\/a><\/li>\n        <li><a href=\"\/dph\/php\/emsps.html\">Emergency Preparedness<\/a><\/li>\n        <li><a href=\"\/dph\/healthandwellness.html\">Health &#038; Wellness<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/healthyhomes.html\">Healthy Homes<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/healthywp.html\">Healthy Workplaces<\/a><\/li>\n        <li><a href=\"\/dph\/lab\/labs.html\">Laboratory<\/a><\/li>\n        <li><a href=\"\/dph\/hsp\/feir.html\">Restaurant Inspections<\/a><\/li>\n        <li><a href=\"\/dph\/screen.html\">Screening and Testing<\/a><\/li>\n        <li><a href=\"\/dph\/chca\/dphwichominf01.html\">WIC<\/a><\/li>\n        <li><a href=\"\/dph\/servicesadd.html\">Additional Services<\/a><\/li><li>\n      <\/li><\/ul>\n    <\/li>\n    <li class=\"toplevel\"><a data-parent=\"#sidebar\" data-toggle=\"collapse\" href=\"#InformationMenu\"><h2>Information <i class=\"fa fa-caret-right fa-fw\"><\/i><\/h2><\/a>\n        <ul class=\"panel-collapse collapse\" id=\"InformationMenu\">\n        <li><a href=\"\/dph\/factsheetsaz.html\">A-Z Fact Sheets<\/a><\/li>\n        <li><a href=\"\/dph\/pubreportsaz.html\">A-Z Publications &#038; Reports<\/a><\/li>\n        <li><a href=\"\/dph\/diseasesandconditions.html\">Diseases &#038; 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  \n\n\n<h2 class=\"center\">Health\n\n\n<!--[type=EDIT name=\"DHANType\"]-->\n\n\n\n\n\nAlert<!--[END]-->\n\n\n<br>\n\n\n<!--[type=EDIT name=\"DHAN Heading\"]-->\n\n\n\n\n\nBE AWARE OF SCAMS ADVERTISING UNAPPROVED COVID-19 TESTS<!--[END]-->\n\n\n<\/h2>\n\n\n\n\n\n<!--[type=HTMLEDIT name=\"Content\"]-->\n\n\n\n\n\n<h2>Summary<\/h2>\n\n\n\n\n\n\n\n\n\n<p>The Division of Public Health (DPH) is issuing this health alert to advise that health care practitioners are being contacted by certain laboratories and commercial manufacturers advertising COVID-19 diagnostic and serology tests that are not approved or granted Emergency Use Authorizations (EUA) by the U.S. Food and Drug Administration (FDA).<\/p>\n\n\n\n\n\n\n\n\n\n<h2>Background<\/h2>\n\n\n\n\n\n\n\n\n\n<p>Many of these communications may be scams and DPH advises all health care professionals to be alert to this new type of fraud.<\/p>\n\n\n\n\n\n\n\n\n\n<p>Health care professionals should not use diagnostic or serology tests that are not approved or have not been granted EUAs by the FDA, and should immediately stop using COVID-19 tests found on the FDA\u2019s lists of tests for which EUA applications have been denied (the \u201cremoved\u201d test lists). All testing must be performed in compliance with the Occupational Health and Safety Administration and Clinical Laboratory Improvement Amendments regulations or if conducted in a clinical laboratory setting, in accordance with standards set forth by the Commission on Office Laboratory Accreditation.<\/p>\n\n\n\n\n\n\n\n\n\n<p>The FDA recommends that health care providers:<\/p>\n\n\n\n\n\n\n\n\n\n<ul>\n\n\n\n\n <li>Verify <a href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/faqs-testing-sars-cov-2#offeringtests\">here<\/a> prior to use whether any tests provided are approved by, or have been granted EUAs from, the FDA;<\/li>\n\n\n\n\n <li>Monitor and review the FDA\u2019s <a href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-covid-19-and-medical-devices\/faqs-testing-sars-cov-2#nolonger\">\u201cremoved\u201d test lists<\/a>;\u00a0<\/li>\n\n\n\n\n <li>Evaluate, given the patient\u2019s clinical presentation and medical history, whether prior test results generated using these tests may have been incorrect, and whether the patient should be retested using an FDA-approved or FDA-authorized test;<\/li>\n\n\n\n\n <li>Remove from stock any remaining tests that are not FDA approved or authorized, including those listed on the FDA\u2019s \u201cremoved\u201d test lists; and<\/li>\n\n\n\n\n <li><a href=\"https:\/\/www.fda.gov\/safety\/medwatch-fda-safety-information-and-adverse-event-reporting-program\">Report<\/a> any issues with COVID-19 tests to the FDA.<\/li>\n\n\n\n\n<\/ul>\n\n\n\n\n\n\n\n\n\n<p>Continuing to use tests found on the \u201cremoved\u201d test lists could put patients\u2019 health at risk and may subject health care professionals to disciplinary action by licensing boards. Therefore, be sure to frequently check the FDA\u2019s \u201cremoved\u201d test lists and the list of COVID-19 tests that the FDA has approved, above.<br>\n\n\n\n\n\u00a0<\/p>\n\n\n\n\n\n\n\n\n\n<h2>Reporting\u00a0<\/h2>\n\n\n\n\n\n\n\n\n\n<p>All COVID-19 test results from any laboratory must be reported to DPH via the Delaware Electronic Reporting Surveillance System (DERSS). Providers must confirm with their designated laboratories that they have the ability to transmit results to DERSS through approved methods \u2013 additional information regarding, and questions about, laboratory reporting can be requested through <a href=\"mailto:reportdisease@delaware.gov\">reportdisease@delaware.gov<\/a>.<\/p>\n\n\n\n\n\n\n\n\n\n<p>Failure to comply with regulations surrounding the reporting of testing may result in fines ($100.00 &#8211; $1,000.00 per violation under DHSS\u2019 authority under 16 Del. C. 107(a)) and\/or other penalties as deemed necessary and appropriate.<\/p>\n\n\n\n\n\n\n\n\n\n<p>If you have information about or are the victim of any of these scams, please submit a complaint to the FDA either by email at <a href=\"mailto:FDA-COVID-19-Fraudulent-Products@fda.hhs.gov\">FDA-COVID-19-Fraudulent-Products@fda.hhs.gov<\/a> or via the FDA\u2019s reporting systems <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/email\/oc\/buyonline\/english.cfm\">here<\/a> (English) or <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/email\/oc\/buyonline\/spanish.cfm\">here<\/a> (Spanish). Also contact the Office of Health Systems Protection at <a href=\"mailto:HSPContact@delaware.gov\">HSPContact@delaware.gov.<\/a><br>\n\n\n\n\n\u00a0<\/p>\n\n\n\n\n\n\n\n\n\n<h2>Additional Information<\/h2>\n\n\n\n\n\n\n\n\n\n<p>Health care providers can find additional information in the FDA\u2019s <a href=\"https:\/\/www.fda.gov\/medical-devices\/letters-health-care-providers\/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and\">Letter to Clinical Laboratory Staff and Health Care Providers<\/a> and on the <a href=\"https:\/\/www.fbi.gov\/news\/press-releases\/fbi-warns-of-potential-fraud-in-antibody-testing-for-covid-19\">FBI\u2019s alert, FBI warns of Potential Fraud in Antibody Testing for Covid-19<\/a><\/p>\n\n\n\n\n\n\n\n\n\n<p>Additionally, as testing \u2014 both laboratory and point-of-care \u2014 becomes increasingly available in the ambulatory and outpatient care space, it is critical that providers remain compliant with regulations regarding the reporting of SARS-CoV-2 testing. The Department of Health and Social Services\u2019 March 10, 2020 order requiring all labs to immediately report all tests and all results to DPH remains in effect. All COVID results, positive AND negative, are reportable.<\/p>\n\n\n\n\n\n\n\n\n\n<p>A list of private and commercial laboratories that are currently compliant with DPH reporting can be found at <a href=\"https:\/\/coronavirus.delaware.gov\/wp-content\/uploads\/sites\/177\/2020\/09\/Currently-Compliant-Labs-Reporting-to-DPH.pdf\">https:\/\/coronavirus.delaware.gov\/wp-content\/uploads\/sites\/177\/2020\/09\/Currently-Compliant-Labs-Reporting-to-DPH.pdf<\/a>.\u00a0<\/p>\n\n\n\n\n\n\n\n\n\n<p>************************************<\/p>\n\n\n\n\n\n\n\n\n\n<p>You are receiving this email because you are a registered member of the Delaware Health Alert Network.\n\n\n\n\nIf you are not a member and would like to subscribe, please register at <a href=\"https:\/\/healthalertde.org\">https:\/\/healthalertde.org<\/a><\/p>\n\n\n\n\n\n\n\n\n\n<br>\n\n\n\n\n<br>\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 class=\"panel panel-danger\">\n\n\n          <div class=\"panel-heading\">    \n\n\n      <h2>Categories of Health Alert messages:<\/h2>\n\n\n       <\/div>\n\n\n       <div class=\"panel-body\">\n\n\n      <ul>\n\n\n        <li><strong>Health Alert:<\/strong> Conveys the highest level of importance; warrants immediate action or attention.<\/li>\n\n\n        <li><strong>Health Advisory:<\/strong> Provides important information for a specific incident or situation; may not require immediate action.<\/li>\n\n\n        <li><strong>Health Update:<\/strong> Provides updated information regarding an incident or situation; unlikely to require immediate action.<\/li>\n\n\n            <\/ul>\n\n\n         <div><strong>NOTE: This page is for informational purposes only and dated material (e.g. temporary websites) may not be available.<\/strong><\/div>\n\n\n          <\/div> \n\n\n        <\/div><br>  \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 Health Alert Network #436 October 1, 2020 10:15 am 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 [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":9294,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-10408","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10408","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=10408"}],"version-history":[{"count":1,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10408\/revisions"}],"predecessor-version":[{"id":11584,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/10408\/revisions\/11584"}],"up":[{"embeddable":true,"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/pages\/9294"}],"wp:attachment":[{"href":"https:\/\/dhss.delaware.gov\/dph\/wp-json\/wp\/v2\/media?parent=10408"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}