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It walks laboratories through completing Form CMS-116, including required general information, first-time applicant rules, facility address and email details, and how to match testing complexity with certificate types. Guidance also covers international laboratory definitions and next steps for selecting a certificate, receiving a fee coupon, and paying applicable CLIA fees.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/laboratory-quick-start-guide-to-cms-clia-certification-november-2024/515722/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/laboratory-quick-start-guide-to-cms-clia-certification-november-2024/515722.png","ImageObject",300,407,{"name":92,"@type":93},"Fahsai","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-28","2026-10-06",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What is the purpose of CLIA for U.S. clinical laboratories?","Question",{"text":113,"@type":114},"CLIA regulates the quality and safety of U.S. clinical laboratories to help ensure accurate, reliable, and timely patient test results. Laboratories must meet CLIA quality requirements.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"How should first-time applicants complete Form CMS-116 regarding the CLIA Identification Number?",{"text":118,"@type":114},"For first-time applicants, the CLIA Identification Number is left blank. After the application is processed, the number is assigned.",{"name":120,"@type":111,"acceptedAnswer":121},"How do laboratories choose the correct CLIA certificate type?",{"text":122,"@type":114},"Select the certificate based on the highest level of test complexity performed by the laboratory. Waived, moderate, and high complexity tests correspond to different certificate options described in the guide.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},515722,1791495862,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":19,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":52,"preview_page_count":4},549768702563,"https://ap-avatar.wpscdn.com/avatar/8000c4aa63b76e948b?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786536092046926083","LABORATORY QUICK START GUIDE TO CMS CLIA CERTIFICATION  \nNOVEMBER 2024  \nLaboratory Quick Start Guide to CMS CLIA  \nCertification  \nThe 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. CLIA has regulatory requirements for quality that all laboratories must meet. This guide helps laboratories seeking to apply for CLIA certification from CMS. More information can be found on the CMS CLIA website.  \nComplete Form CMS-116  \n• Download this fllable form and type your responses in each section. Make  \nsure you save it as a PDF on your computer.  \nInclude information based on the date of form completion.  \nAll applicable sections must be completed. Incomplete applications cannot be processed.  \nTo find out if the testing your laboratory is performing is categorized as waived, moderate, or high complexity-refer to the FDA website. If you are unable to locate the test complexity of your laboratory testing, contact your State Agency.  \nFor a complete list of instructions,  \nComplete General Information in  \nsection I.  \nFirst-time applicants check“Initial Application.”  \nFor an initial applicant, the CLIA Identification Number is left blank. When the application is processed, the number is assigned.  \nFacility Address must refect the physical location where the laboratory testing is performed. The address may include a foor, suite and/or room location, but cannot be a Post O°ce box or Mail Stop.  \nInclude your laboratory’s most  \nup-to-date email address so you get important updates from CMS.  \nTip: Include a business email address that many laboratory sta˝ access and use.  \nWhen you check the box to opt in, CMS will send electronic certifcates and fee coupons directly to your email. You won’t need to wait for paper versions to come in the mail.  \nInternational  \nLab Facilities  \nFor CLIA purposes, an international laboratory is a facility outside the U.S. or its territories that performs clinical laboratory tests referred by and returned to a facility in the U.S. or its territories.  \nSTEP 1:  \n•  \n•  \n•  \n•  \nrefer to page 6 of Form CMS-116 .  \nPage 1  \nDisclaimer: This guide is a restatement of the law intended to assist people in understanding the basics about the CLIA program, and that the reader should consult the relevant statutesand regulations for the full scope of the CLIA requirements.  \nLABORATORY QUICK START GUIDE TO CMS CLIA CERTIFICATION  \nNOVEMBER 2024  \nComplete Type of Certificate Requested in section II.  \nIn section II, Type of Certificate Requested, select your certifcate based on the highest level of test complexity performed by the laboratory (Note: all CLIA certifcates are valid for 2 years):  \n• Waived tests are simple examinationsand procedures that have an insignifcant risk of an erroneous result. See CLIA  Currently Waived Analytes.  \n• Moderate complexity tests require minimal scientifc and technical knowledge.  \n• High complexity tests are more di°cult to perform or interpret than moderate and waived tests. Specialized scientifc knowledge and training are required.  \nMore information about each certifcate can be found below:  \n• Certificate of Waiver (CoW): Issued to a laboratory that only performs waived tests.  \n• Certificate for Provider Performed  Microscopy Procedures (PPM): Issued to a laboratory in which a physician, midlevel practitioner, or dentist performs only specifc microscopy procedures during a patient’s visit. See list of PPM procedures, which are a subset of moderate complexity tests.  \n•  \nCertificate of Registration (CoR): ACoR is temporary and permits the laboratory to conduct nonwaived (moderate and/or high complexity) tests until the laboratory is inspected and found to be in compliance  \nwith CLIA regulations. The CoR is valid for no more than 2 years. Only l","cbCailANbWW3HIQi","https://ap.wps.com/l/cbCailANbWW3HIQi","pdf",5139625,"English","# Complete Form CMS-116\n## General information requirements (Section I)\n## Type of certificate requested (Section II)\n# International Lab Facilities\n# Receive Fee Coupon and Pay Applicable Fees\n## Fee schedule and payment steps","[{\"question\":\"What is the purpose of CLIA for U.S. clinical laboratories?\",\"answer\":\"CLIA regulates the quality and safety of U.S. clinical laboratories to help ensure accurate, reliable, and timely patient test results. Laboratories must meet CLIA quality requirements.\"},{\"question\":\"How should first-time applicants complete Form CMS-116 regarding the CLIA Identification Number?\",\"answer\":\"For first-time applicants, the CLIA Identification Number is left blank. After the application is processed, the number is assigned.\"},{\"question\":\"How do laboratories choose the correct CLIA certificate type?\",\"answer\":\"Select the certificate based on the highest level of test complexity performed by the laboratory. Waived, moderate, and high complexity tests correspond to different certificate options described in the guide.\"}]","LABORATORY QUICK START GUIDE TO CMS CLIA CERTIFICATION - NOVEMBER 2024 | PDF",1791321589]