clia inspection checklist 2021
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clia inspection checklist 2021

Laboratories are required to permit CMS or its representatives to conduct an inspection. Laboratories that utilize these strategies can be inspection-ready at all times. November 2021. Before sharing sensitive information, make sure you're on a federal government site. CLIA INSPECTION GUIDANCE DOCUMENT 2013 5 Clinical Lab Improvement Amendments (CLIA), CMS: Individualized Quality Control Plan (IQCP), CMS: Individualized Quality Control Plan (IQCP) Workbook, CMS: List of CPT-4 and HCPCS Codes Non-waived Tests subject to edits (CMS), FDA: CLIA - Test Complexity Determination, IL Secretary of State Corporation/LLC Search, IRS: Not-for-profit (federal 501(c)(3) tax determination letter, Medicare Provider Enrollment and Certification, CLIA Regulations How do they Affect my Lab (CDC), Verifications of Performance Specifications (CDC), Calibration and Calibration Verification (CDC), Equivalent Quality Control Procedures (CDC), Proficiency Testing - DOs and DON'T's (CDC), How to Perform Lab Personnel Competency Assessments (CDC), Individualized Quality Control Plan - IQCP (CDC & CMS), Ready? The Checklists used for inspection by the College of American Pathologists' Accreditation Programs have been created by the CAP and are copyrighted works of the CAP. Year over year customers report 98% satisfaction. >> @~ (* {d+}G}WL$cGD2QZ4 E@@ A(q`1D `'u46ptc48.`R0) Many of the most frequently asked CLIA . "The inspection process is designed to be collaborative," shares Bakken. It's an opportunity for improvement.". 2021; 2020; 2019; 2018; 2017; 2016; News by Topic SUBSCRIBE TO RSS FEED XML. To Apply for a Certificate of Compliance or Certificate of Accreditation Labs NOT located in Oregon: Find your state agency and mail forms to them (pdf) CLIA Fees and Application CLIA CMS-116 application form (pdf) Boston, Massachusetts, United States . The clinical investigator inspections were conducted as part of the Food and Drug Administration'sBioresearch Monitoring Program (BIMO) within the Center for Drug Evaluation and Research (CDER). How much time a lab needs depends on its complexity and the volume of instrumentation it uses. Accreditation Checklists Developed with input from more than 500 pathologists and laboratory experts, our 21 discipline-specific accreditation checklists provide a clear roadmap for not only achieving accreditation but also for running a high-quality laboratory. Inspectors will look at QC for those dates and patient outcomes, such as documentation of critical labs and actions taken. There are four types of CLIA certificates. To contact the CLIA Program you may contact us by email at CLIA@health.mo.gov or by telephone at 573-751-6318. Accreditation fee The ASHI Accreditation fee is $2,060. It looks like your browser does not have JavaScript enabled. README.TXT contains descriptions of the codes in the database. By offering Clinical Chemistry and Immunoassay testing (Chem/IA) in-house, you can provide your patients with fast, accurate results during their regular office visits. CLIA Laboratory Program Mail check to: CLIA Laboratory Program, P.O. Read More Under CLIA, a laboratory is defined as a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings. April 2022. This program certifies, inspects and monitors clinical laboratories for compliance of state and federal CLIA regulations, and investigates complaints received to ensure clinical laboratory testing is accurate, effective and reliable. Unexpected DocumentServiceException: error.content.DocServiceError Access CAP Home New laboratories are assigned to a specific cycle based on when their application is submitted for review. Working with a consultant with expertise in CLIA inspection preparation can help resolve concerns before they become deficiencies or, worse, put a laboratory in immediate jeopardy. See the Consumer Complaints FAQ (PDF) on how to file a complaint. Transcripts . Based on their license renewal cycle, clinicians running moderate and high complexity testing laboratories will undergo Clinical Laboratory Improvement Amendment (CLIA) inspections every two years. (b) General requirements. << /N 3 CLIA-exempt laboratory means a laboratory that has been licensed or approved by a State where CMS has determined that the State has enacted laws relating to laboratory requirements that are equal to or more stringent than CLIA . The division also collects data regarding . Reset CLIA - PRE-INSPECTION . MFk t,:.FW8c1L&9aX: rbl1 WOULD YOU LIKE TO RECEIVE EMAIL UPDATES FROM CLIA? The CLIA program performs routine inspections of over 800 laboratories and validations of 36 accredited facilities each year. Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website. While the requirements across all organizations with accreditation authority differ slightly, they all represent adherence to a higher standard of quality than with CLIA compliance alone. All information these cookies collect is aggregated and therefore anonymous. If you identify any errors with your logs, it's important to develop and document your own corrective plan of action. The CLIA historical numbers file is from January 2022. Here is a basic guide to help you prepare for a CLIA inspection. Certificate of Waiver: Performs tests granted waived status by the FDA. In general, CAP has more specialty-specific quality standards than other accreditation organizations. If facilities have concerns, having a consultant involved can help with their CLIA inspection preparation process. BioAgilytix for Large Molecule Drug Development Under CLIA. Sign up for our CLIA Communications Email List with the link below: https://public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461. You can verify receipt of your forms by calling 503-693-4125 or by e-mailing LC.info@odhsoha.oregon.gov. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988, and under CLIA, a laboratory is defined as a facility that performs applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the . This information is intended for use only by competent healthcare professionals exercising judgment in providing care. . The program's mission is to ensure the highest quality of laboratory testing is performed in the state through the use of education and enforcement of state and federal CLIA regulations. Find information about the Clinical Laboratory Improvement Advisory Committee (CLIAC), which is managed by the Centers for Disease Control and Prevention (CDC), provides scientific and technical advice and guidance to the Department of Health and Human Services (HHS). The Missouri CLIA program oversees this certification program in our state and carries out certain inspections of laboratories on a routine basis, as well as investigating complaint allegations. CMS or its representatives may conduct validation and complaint investigation inspections of any accredited or CLIA-exempt laboratory at any time during its hours of operation. They include comments, technical tips and the applicable literature references. An official website of the United States government website belongs to an official government organization in the United States. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance. Under CLIA, a laboratory is defined as a facility that performs testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of health of, human beings. Review Board The first 2 digits of your ASHI laboratory accreditation number indicate what region (non-geographic) you are in. Compile the manuals, documents and information listed in this section and have them ready and retrievable for the survey. Amendments (CLIA) Certificate of Waiver. Learn more about CLIA. (916) 558-1784, COVID 19 Information Line: Although CLIA is a federal program, State Agencies (SAs) are responsible for laboratory oversight and maintaining CLIA laboratories certification records. Provide feedback on your experience with DSHS facilities, staff, communication, and services. In 1991, Congress passed Public Law (Pub. As a result of that inspection, Department examiners determined that your laboratory is not in compliance with the requirements specified in the Health and Safety Code section 101160 and/or California Code of Regulations, title 17, sections 1078 and 1083. (1-833-422-4255). The CLIA inspectors review each lab's policies and procedures to help improve quality and compliance. The CMS 116 CLIA Applications may be completed for any changes. Test samples, including proficiency testing, or perform procedures. Secure .gov websites use HTTPSA From setup, to ongoing lab consulting, and compliance training, our MedSol program's licensed professionals can provide the support you need for your laboratory. Denos su opinin sobre sus experiencias con las instalaciones, el personal, la comunicacin y los servicios del DSHS. CMS 116 CLIA Application. lock 1-833-4CA4ALL V E,2 ~" V f?@$W ~DI(3^)";Z&,L`B w+#:mt"30T0 Vx N.J.S.A. Legal Disclaimer: The information provided on TemplateRoller.com is for general and educational purposes only and is not a substitute for professional advice. ) /Producer (thunderhead.com) Should an accredited laboratory fail to be in compliance with one or more condition-level requirements, it is subject to a full review by CMS; should a CLIA-exempt laboratory fail to be in compliance with one or more condition-level requirements, it is subject to appropriate enforcement actions under the approved state licensure program. Inspections can be very valuable for laboratories. To assess compliance with FDAs regulations governing the conduct of clinical and nonclinical trials, including regulations for informed consent and ethical review. Documentation Consult with the appropriate professionals before taking any legal action. 1 - January 19, 2021 Issue Why Are Health Systems Changing CLIA Accreditors? % Additionally, see the Temporary COVID-19 Testing Sites (PDF) infographic, which advises those receiving laboratory services of things to be aware of to ensure they are receiving quality laboratory testing. %PDF-1.4 The Centers for Medicare & Medicaid Services (CMS) regulates CLIA certification with assistance from the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).1 Its purpose is to protect patient safety and make sure laboratories maintain quality standards at the federal level.2. Laws and Regulations Federal Laws and Regulations The mission of the Clinical Laboratory Improvement Amendments (CLIA) section of Laboratory Field Services is to ensure compliance with State and federal clinical laboratory laws and regulations by performing biannual onsite inspections to ensure accuracy and reliability of laboratory test results and conducting review of laboratory performed proficiency testing results. Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. CDC twenty four seven. You can review and change the way we collect information below. This digitized template, as well as other SafetyCulture (iAuditor) fire marshal inspection checklists, can be edited to fit the . 2021, c. 454 as amended by P.L. Official websites use .govA (CLIA). January 2022. Welcome to the Illinois Clinical Laboratory Improvement Amendments (CLIA) Program. /Length 12 0 R Find links for answers to frequently asked questions on the CLIA Quick Tips pageor email CMS directly. Permit interviews of all personnel concerning the laboratory's compliance. Valentine's Day Crafts and Activities for Kids, Secret Santa 2022 - How to Plan the Perfect Secret Santa, How to Organize Christmas on a Budget in 2022, Making Christmas Fun for Kids in 2022 - Useful Tips, Celebrating Thanksgiving at Home with Kids, Fun Ideas to Celebrate Halloween With Your Kids in 2022. By using this site you agree to our use of cookies as described in our UPDATED . Copyright 2023 American Academy of Family Physicians. The CLIA top ten deficiencies information in the Downloads section is from the CMS CLIA database in 2021. hb```u ea0'CP7HQ"Kl]o#+-}GGcEGG3j``@*` %X,AA{*w8|>09c3Qg/s^Fv;! L 70@.:H30(g yd`=;x 0 Y7 Please note that the BIMO information for other centers is not available here. An official website of the United States government Official websites use .govA October 2021By Jan. 1, 2024, laboratories must use current breakpoints to interpret antimicrobial minimum inhibitory concentration and disk diffusion test results, according to a new requirement in the latest edition of the CAP Accreditation Programs microbiology checklist, released Sept. 22. Some states also have laboratory licensing laws separate from the CLIA regulations, so please check with your SA before your laboratory begins testing. to Default, Registered Environmental Health Specialist, California Health Facilities Information Database, Chronic Disease Surveillance and Research, Medical Marijuana Identification Card Program, Office of State Public Health Laboratory Director, Centers for Disease Control and Prevention, Clinical Laboratory Improvement Amendments (CLIA). (with different CLIA/CAP numbers) to provide a final, reportable result for the originally-ordered test. Compliance and Inspection Survival Advice for CLIA, The Joint Commission, CAP and COLA Successful Strategies and Specific Applications of the Regulations 2021, 274 pages, 11" by 9" workbook format, wire coil binding ISBN 1-886958-35-1 ISBN-13 978-1-886958-35-7 List price: $80.00 REVISED. hbbd```b`` 3@$A 4: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/cliabrochure.pdf A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for . (a) A laboratory issued a certificate must permit CMS or a CMS agent to conduct an inspection to assess the laboratory's compliance with the requirements of this part. Self-inspect your laboratory. In general, CLIA inspectors give two weeks' notice for announced initial and renewal inspections although an unannounced visit could occur at any time. The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. 4 0 obj CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Each of the downloadable files is in ASCII format and is tilde (~) delimited. 2: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/cliaback.pdf 690 0 obj <>/Filter/FlateDecode/ID[<06149A7609124B43A4423B7A92F972BD>]/Index[664 47]/Info 663 0 R/Length 124/Prev 380663/Root 665 0 R/Size 711/Type/XRef/W[1 3 1]>>stream Learn more about MedSol >. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Clinical Laboratory Improvement Advisory Committee (CLIAC), Centers for Disease Control and Prevention. TemplateRoller.com will not be liable for loss or damage of any kind incurred as a result of using the information provided on the site. Want to get in touch to learn how we can help support your lab? After extraction, you will have two files: CLIIL.TXT and README.TXT. How to Apply for a New CLIA Certificate 1. Facilities and physician offices should check they have a record of their personnel's credentials and competencies at initial hire, again at six months and then annually.4. Bakken explains that clinicians should encourage their personnel to respond to an inspector's questions honestly and provide answers on the items or records in question. Home Fire Hazard Inspection Check List - Scottsdale, Arizona, Clia Certificate Type Change Form - Illinois, DNR Form 542-0269 Iowa DNR Public Water System Security Inspection Check List - Iowa, Form DLT-L-129 Electric Elevator Inspection Check List - Rhode Island, Form DLT-L-133 Escalator Inspection Check List - Rhode Island, Form DLT-L-130 Hydraulic Elevator Inspection Check List - Rhode Island, Attachment C Mixing Valve Inspection Check List - Sample - South Carolina, Attachment G Hvac Inspection Check List - Sample - South Carolina, Attachment F Generator Inspection Check List - Sample - South Carolina. 0 lock The data are updated quarterly. These cookies may also be used for advertising purposes by these third parties. This option is available every other survey cycle (a two-year period). While laboratories issued a certificate of waiver or certificate for provider performed microscopy are not subject to biennial inspections, CMS or its representatives may conduct inspections at any time during the laboratory's hours of operation to: Waived and PPM laboratories must comply with all of the basic inspection requirements. Quality, Safety & Oversight - Certification & Compliance, How to Apply for a CLIA Certificate, Including International Laboratories, Accreditation Organizations/Exempt States, Certification Boards for Laboratory Directors of High Complexity Testing, CLIA Regulations and Federal Register Documents, CLIA Related Hearing Decisions and Compliance Topics, Individualized Quality Control Plan (IQCP), State Agency & CLIA Operations Branch Contacts, CME Courses for Laboratory Directors of Moderate Complexity Laboratories, /Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf (PDF), https://public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461, CLIA of 1988 Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-F) FAQ Sheet 7/7/2022 (PDF), CLIA University Lab Testing 8/28/2020 (PDF), Frequently Asked Questions (FAQs), Abbott i-STAT - Updated 12-08-2022 (PDF), Research Testing and CLIA 12/10/2014 (PDF), Partners in Laboratory Oversight 09/2006 (PDF), Live Blood Cell Analysis Under CLIA 03/17/2017 (PDF), MLN006270 - CLIA Program & Medicare Lab Services December 2021 (PDF), CLIA Fee, Histocompatibility, Personnel, Alternative Sanction NPRM CMS-3326-P 07/22/2022 (PDF), CLIA SARS-CoV-2 Point Of Care Test Enforcement Discretion - Updated 10/7/2022 (PDF), SARS-CoV-2 Point of Care Testing and CLIA Certificate of Waiver Applications - Updated 12-17-2020, Frequently Asked Questions FAQs CLIA Guidance During the COVID-19 Emergency - Updated 12-17-2020, How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices 08/05/2015, CDC PPMP - A Focus on Quality Practices Booklet, All other questions about the CLIA program should be submitted to. A laboratory must have all records and data accessible and retrievable within a reasonable amount of time during the inspection. /Creator (thunderhead.com) Get the Right Results (CDC), To Test or Not to Test Booklet - Considerations for Waived Testing (CDC), How to Obtain a CLIA Certificate of Waiver (CMS), Laboratory Director Responsibilities (CMS), Behavioral Risk Factor Surveillance System, Pregnancy Risk Assessment Monitoring System, Making Changes to your CLIA Certificate & CLIA Payment Instructions, Post Clinical Laboratory Survey Questionnaire, Disclosure or Change of Ownership and Tax ID, Health Screening Event Requirements and Approval Request Form (for TESTING and COLLECTION of specimens), Health Wellness Event Requirements and Approval Request Form (for collection of specimens ONLY), Laboratory Name, Address, and Email Change, Grant Accountability and Transparency (GATA). These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. Our mailing address, email, and fax are listed in the "Contact Information" section of this page. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. 664 0 obj <> endobj Participants usually need to register well in advance,so clinicians should allow plenty of time to complete proficiency testing well before inspection time, Personnel competency binders can help organize staff training documentation. You can decide how often to receive updates. 7500 Security Boulevard, Baltimore, MD 21244, An official website of the United States government. Failure to permit an inspection of any type results in suspension or cancellation of the laboratory's participation in Medicare and Medicaid for payment and suspension or limitation of or action to revoke the laboratory's CLIA certificate. The .gov means its official.Federal government websites often end in .gov or .mil. Those predictions are now becoming a reality as providers adopt next generation sequencing-based tests. For decades, experts have predicted genomic technology would transform patient care. UPDATED. These records should be identified and the location communicated to the relevant staff. lock An integrated LIS can help laboratories struggling with staffing challenges. or Use this general guideline in addition to your inspection agency's specific requirements. >> All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements. The Los Angeles LFS Office manages the CLIA program. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA. EXPANDED. -Performed weekly lab walkthroughs and mock audits for CLIA compliance and inspection readiness . Complete all forms in the Pre-Survey Packet prior to the survey. endstream endobj 665 0 obj <. Provide CMS or its representatives with copies or exact duplicates of all records and data it requires. Laboratory Field Services. Saving Lives, Protecting People, Clinical Laboratory Improvement Amendments (CLIA), U.S. Department of Health & Human Services. To contact the Los Angeles Use this list only as a guide to prepare your laboratory. Cookies used to enable you to share pages and content that you find interesting on CDC.gov through third party social networking and other websites. Quality, Safety & Oversight - Certification & Compliance, Clinical Laboratory Improvement Amendments (CLIA), How to Apply for a CLIA Certificate, Including International Laboratories, Accreditation Organizations/Exempt States, Certification Boards for Laboratory Directors of High Complexity Testing, CLIA Regulations and Federal Register Documents, CLIA Related Hearing Decisions and Compliance Topics, Individualized Quality Control Plan (IQCP), State Agency & CLIA Operations Branch Contacts, CME Courses for Laboratory Directors of Moderate Complexity Laboratories, CLIA Historical Numbers - January 2022 (PDF), CLIA Top Ten Deficiencies in the Nation - 2021 (PDF), CLIA Update Statistics - March 2023 (PDF), Laboratories By Facility Type Under CLIA - March 2023 (PDF), Certificate of Compliance Laboratories By CLIA Certificate Schedule - March 2023 (PDF), Total CLIA Laboratories Registered - March 2023 (PDF), Percent of CLIA Laboratories By Certificate Type - March 2023 (PDF), Physician Office Laboratories Under CLIA - March 2023 (PDF), Laboratories By Certificate Type Under CLIA - March 2023 (PDF), CLIA Accredited Laboratories - March 2023 (PDF). To contact the Los Angeles LFS Office please call (213) 620-6160. There are different types of CLIA certifications based on the diagnostic tests laboratories perform. accreditation standards that are translated into detailed checklist requirements organized into 21 discipline-specific checklists . xwTS7PkhRH H. To report a complaint about a laboratory, contact the appropriate State Agency (PDF) that is found on the State Agency & Regional Office CLIA Contacts page located in the left-handnavigationpane in this section. | From the Volume XXVIII, No. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. We take your privacy seriously. Cookies used to make website functionality more relevant to you. Determine which type of CLIA certificate is needed. The list below is not all-inclusive, but represents the basic items required. Heres how you know. CLIA Regulation and GuidanceThe Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). Expiration Date: 3/31/2021. Although CLIA is a federal program, State Agencies (SAs) are responsible for laboratory oversight and maintaining CLIA laboratories certification records. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). Tests that are waived by regulation under 42 CFR. February 2022. Home Official State of Nevada Website . The CLIA inspection regulations are found in Subpart Q of the Code of Federal Regulations, which addresses both basic and specific inspection requirements. Be prepared and organized. December 2021. The CLIA program performs routine inspections of over 800 laboratories and validations of 36 accredited facilities each year. For over thirty years, we have refined our unique educationally-focused accreditation experience. The time required to complete this information collection is estimated to average one hour per response, including the time to review instructions, search existing data resources, gather the data needed, Occasionally, if an inspector uncovers missing competencies, concerns with QC or other deficiencies, they may interview lab personnel to better understand their testing knowledge or related background.5. Learn more about CDCs laboratory quality efforts. The CLIA historical numbers file is from January 2022. Although some of the recommendations in this self-assessment checklist exceed CLIA requirements for waived testing, Depending on individual circumstances, the surveyor may request . This site uses cookies to enhance site navigation and personalize your experience. Recently, CLIA laboratories owned and operated by Flow Health have been inspected in California, Georgia . By offering point-of-care testing in your community health center, you can provide same day results to start treatment sooner and improve patient compliance. The following list of required laboratory practices and documents is an overview of what the on-site survey inspection may consist off; however, please know that additional documents may be required by the surveyor. January 19, 2021 Intelligence: Late-Breaking Lab News MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Determine whether the laboratory is performing tests beyond the scope of the laboratory's certificate. .gov SetTest! Please turn on JavaScript and try again. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. Instructions on how to apply for a clinical laboratory registration or license and federal CLIA certificate for waived, provider performed microscopy procedures, moderate or high complexity testing are found on the Laboratory Field Services (LFS) Clinical Laboratory Facilities webpage. Feel free to contact the program for answers to technical and regulatory questions. CMS's policy for inspections includes an announced initial and biennial recertification inspection and unannounced complaint and follow-up inspections. June 2022. clia inspection checklist 2021 The fda received infectious wastes must be reverified at fda blood bank inspection checklist was not considered high risk management systems inspected by using the final responsibility. 710 0 obj <>stream CLIA Statistical Tables/Graphs. ?:0FBx$ !i@H[EE1PLV6QP>U(j Checklists This section contains copies of the parameter/method/technology checklists used by NC WW/GW Laboratory Certification auditors during the on-site inspections of laboratories. ) requested, for a two-year period prior to the survey, or from the date of the last survey/ CMS CLIA inspection. Commissioners are listed in the above link by region. There's value in working with someone with a variety of expertise to assist with any of these inspection scenarios.

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clia inspection checklist 2021