what is not considered a clia waived test?

var alS = 1002 % 1000; A waived test is a simple point-of-care (POC) test whose process uses a one- to two-step process, requiring minimal interpretation and rarely requires special training to perform (for example, a urine pregnancy test or a blood glucose test). Manage Settings CLIA is the governing body for all labs in the U.S. outside of military installations. On the other hand, tests with a moderate to a high level of complexity are non-waived. Test! what to wear to a financial advisor interview; kelly jean lucky luciano age; who is eric and monica on selling yachts; irwin jacobs daughter; food left out overnight in tupperware; what is a well constrained fault; land for sale in domboshava; soldiers and sailors memorial auditorium covid policy . A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. lock Laboratories must still follow all written protocols provided by the vendor or manufacturer and only perform the highest level of testing allowed by their CLIA certificate. The FDA's CLIA waiver mandates that the test system retain a minimal risk of mistake or incorrect results and that the test be straightforward and understandable. Most COVID-19 tests on the market have only been granted emergency use by the FDA and have a time limit/expiration date on their usage that can change at any time. To successfully run a laboratory in the United States, clinicians must adhere to CLIA standards, prepare for a CLIA inspection every two years and correct any errors found in such an inspection to remain in operation. 2. They can read or report on the results without having to travel to a clinical lab or ship the test system there for analysis and results. Everything I read on this subject states it is a clia waived test. Each test has its own set of guidelines and instructions and varies slightly from the others. Non-global OB care or partial services Global OB Care The total obstetric care package includes the provision of antepartum care, delivery services and postpartum care. The booklet contains tips, reminders, and resources along with forms and examples for use in your testing site. waived tests include tests that have been FDA-approved for use by patients at home Quality Control (QC) The most important factor in securely performing and administering CLIA waived tests is to carefully and accurately follow the directions. Tests. In a nutshell, if it's a research lab and performing human tests but not providing test results or subsequent treatment for a patient, a CLIA certificate is not required. All information these cookies collect is aggregated and therefore anonymous. The law continues to be cited as CLIA 88 as named in the legislation.. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. //"value1" will be recorded on our end as-is For example, home-use urine pregnancy tests and other point-of-care tests fall under this category. To decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory practices are followed. a. 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). Youll be able to choose the right products and learn how to use each, minimizing errors in the process. Another example new personnel who are not yet familiar with the, CLIA_waived tests are considered safe for use at, On the other hand, a CLIA waived drug test is cleared by the FDA and considered safe to use at home. Do not assume that a drug testing product line is CLIA Waived as this is typically only the case for detailed specifications. We take your privacy seriously. The performance specifications are: accuracy, precision, test sensitivity and test specificity. Sheet I has a total surface charge density of 6.5nC/m26.5 \mathrm{nC} / \mathrm{m}^26.5nC/m2, sheet II a charge of 2.0nC/m2-2.0 \mathrm{nC} / \mathrm{m}^22.0nC/m2, and sheet III a charge of 5.0nC/m25.0 \mathrm{nC} / \mathrm{m}^25.0nC/m2. 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. Share sensitive information only on official, secure websites. Provider-performed microscopy (PPM) Procedures, Other Terms Related to Test Complexity or Waived Testing, Determining Test Complexities for Specific Tests, Centers for Disease Control and Prevention. So, bear that in mind when choosing the proper item. Its because CLIA still acknowledges that although tests must be simple and have a low risk for erroneous results, they are not entirely error-proof. Waived tests that are approved for use at home are essentially deemed safe tests as a whole. The type of test and the type of human specimen sample affect how the results are interpreted (whether it is urine, saliva, or something else). These early regulations primarily covered independent and hospital labs. Here's what you should consider when expanding your practice with point-of-care testing. Sign up to get the latest information about your choice of CMS topics. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. Ovulation . Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. In 1988, a second amendment was passed providing oversight to all laboratory related facilities that also included physician's offices. The scores for the 7 criteria are added together and tests with a score of 12 or less are categorized as moderate complexity, while those with a score above 12 are categorized as high complexity.. In general, the more complicated the test, the more stringent the requirements under CLIA. Now, for a test to be CLIA waived, it has to be simple. A CLIA certificate is still required to perform a CLIA waived test. 2: https://hub.ucsf.edu/clinical-laboratory-testing lock (adsbygoogle = window.adsbygoogle || []).push({}); Not only for its accurate results but also for its legitimacy when it comes to determining critical information i.e. Are you wondering why waived tests are not 100% accurate? Type of Control - check the type of organization for which you are making this application (private non-profit, for-profit, government). window.ezoSTPixelAdd(slotId, 'adsensetype', 1); This booklet describes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. 3: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf Heres how you know. CLIA waived test that is performed frequently in the medical office, Julie S Snyder, Linda Lilley, Shelly Collins, 100% Cancer Quiz 2 two - What do I not know, Cardiovascular 4 (Pathology of the Myocardium). An official website of the United States government 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. In 1967, the CLIA was passed, and the first lab regulations were born. Regular checkups after a certain age are quite important. To Test or Not to Test? website belongs to an official government organization in the United States. Bookletpdf icon [Spanish]. Cookies used to make website functionality more relevant to you. We and our partners use data for Personalised ads and content, ad and content measurement, audience insights and product development. Learn how POC tests support rapid diagnosis and immediate treatment. Typically, these tests are not distributed or sold commercially. For example, all Exploro tests come with comprehensive instructions for each test on how to do the rapid THC urine test and how to interpret the results. ins.className = 'adsbygoogle ezasloaded'; 4: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincertificateofwaiver.pdf MT(ASCP) & nursing licenses alone aren't acceptable. Waived tests a Laboratory test that meets the CLIA criteria for being a simple procedure that is easy to perform and has a low risk of erroneous test results. Self Assessment Checklist pdf icon[PDF 16 KB]. Modifier QW is defined as a Clinical Laboratory Improvement Amendment (CLIA) waived test. Diagnostic testing allows healthcare providers (doctors, nurses, etc.) What does it mean if a test is CLIA waived? All waived tests may be performed with this level of certificate with the same requirements as a certificate of waiver. ) Now youre wondering what it means. Also, CMS list of PPMP tests (including CPT/HCPCS codes)pdf iconexternal icon. Spanish Version This booklet describes considerations and preparations needed prior to performing waived testing and may assist those who want to implement and oversee waived testing or offer a new test under a CLIA Certificate of Waiver. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Each individual performs only those waived, moderate, or highly complex tests authorized by CLIA, Bus. Official websites use .govA See 42 CFR 493.19. This is interesting, I dont know a lot about these tests but reading you post can help me. Read on to find out about training programmes, consultant companies and other relevant information on OPT and CPT. Developing and issuing implementing rules and guidance for CLIA complexity categorization. to view the complete list of testing systems with FDA approval and CLIA Waived status. Thank you for taking the time to confirm your preferences. The objective of the CLIA program is to ensure quality laboratory testing. How to run a laboratory: The primary care physician's guide to expanding your practice with point-of-care testing. CDC twenty four seven. Waived tests include test systems cleared by the FDA for home use and those tests approved for waiver under the CLIA criteria. What is not considered a CLIA Waived Test? Posterpdf icon [HTML Poster][Spanish], This poster can readily be displayed in a testing area to remind testers of 10 important practices to follow for accurate and reliable testing. All information these cookies collect is aggregated and therefore anonymous. ( Nonwaived testing is subject to inspection, and must meet the CLIA quality system standards, such as those for proficiency testing, quality control and assessment, and personnel requirements. They include: Sites that perform only waived testing must have a CLIA certificate and follow the manufacturers instructions; other CLIA requirements do not apply to these sites. A CLIA waived test is categorized as a simple laboratory examination or procedures that has a low likelihood of an erroneous result according to CLIA.4 The FDA determines whether a test qualifies as waived or not. Your email address will not be published. /*! Use left/right arrows to navigate the slideshow or swipe left/right if using a mobile device, CLIA (Clinical Laboratory Improvement Amendments) waived tests are tests that the United States Food and Drug Administration (FDA) clears according to, . CMS is the federal agency responsible for ensuring the accuracy and quality of an LDT. For questions, please email CMS LAB Excellence at LabExcellence@cms.hhs.gov. 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, Test Complexity Database--All Complexities (FDA Site). dnb_Data.naicsCodes.substr(1,5) : "" CLIA is the acronym of Clinical Laboratory Improvement Amendments of 1988. Please see the FDAs webpage on CLIA Waiversexternal icon. These terms do not relate directly to the test complexity categories, and it cannot be assumed that a test system is waived simply because it is performed at the point of care. ins.id = slotId + '-asloaded'; The inspection schedule is typically every two years, 5 | Certificate of Accreditation: Any independent group where CLIA maintains governance but has regulatory oversight (such as COLA, CAP or the Joint Commission) that must obtain CLIA's accreditation and regulatory standards. Press the space key then arrow keys to make a selection. Heres how you know. There must be a low risk for erroneous results. Waived tests are definted to employ methodologies so simple and accurate as to render the likelihood of erroneous results negligible. As defined by CLIA, waived tests are categorized as "simple . If a State license is required by CLIA, it alone is acceptable. The saying, you get what you pay for is true when it comes to at-home CLIA-waived drug tests. It is good to know about such tests and how to get them done. The specific tests that are deemed to be CLIA waived are: 1. If youre thinking of using drug testing supplies, you might have come across the term CLIA waived tests. Local state regulations must also be considered when using lab tests on the CLIA-waived list. Risk and liability are common concerns, as we all know. In other words, if these tests are simple to use and comprehend when the user complies with the producers' recommendations, they are waived. These cookies perform functions like remembering presentation options or choices and, in some cases, delivery of web content that based on self-identified area of interests. If tests meet the requirements set by this statute, then they may be waived from regulatory oversight. Subscribe for new products, sales, and promotions. https:// Its a popular test that women use to check if theyre expecting. We billed claims for the 87428 with QW modifier and denied stating incomplete invalid procedure modifier. . Estimate the force per unit area on each sheet, in N/m2\mathrm{N} / \mathrm{m}^2N/m2. Required fields are marked *. Two subsequent amendments were made after 1988. Non-automated urinalysis using dipstick or tablet reagents. var ffid = 1; Copyright 2022 Ovusmedical All Right Reserved, Diagnosis, prevention, or treatment of diseases. Read More Ob/Gyn Coding Guidelines 2022Continue, Fracture care coding can be billed for closed treatments with or without manipulation. It's a popular test that women use to check if they're expecting. This waiver allows a "non-clinical" facility to utilize CLIA-waived tests. 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. Personnel requirements vary based on test complexity and state requirements. The standards for moderate and high complexity testing differ only in the personnel requirements. You can find more information on CLIA waived tests at http://www.fda.gov/cdrh/clia/cliaWaived.html. Online Courseexternal icon. Set? Ovus Medical offers drug testing supplies in bulk. Clinical laboratories or other testing sites need to know whether a test system is waived, moderate, or high complexity for each test on their menu because this determines the applicable CLIA requirements. Share sensitive information only on official, secure websites. A test that hasnt been CLIA-waived means that it hasnt passed any CLIA conditions. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. Make sure your billing staffs are aware of these CLIA-related changes. Some things to keep in mind when appending modifier QW to your lab service/s: The modifier is used to identify waived tests and must be submitted in the first modifier field. But, when asking what tests are CLIA waived, what exactly does waived mean? Also, theres no need for a medical or clinical license required for the administrator to administer the test. Compare the capacity and rate at which the respiratory system and kidneys control body fluid pH. For a general overview of CLIA certificate types, see CMS Clinical Laboratory Improvement Amendments (CLIA) Brochure. The federal government, through the CLIA program, thoroughly regulates the evaluation and use of all lab tests including lab-developed assays. Each individual performs only those waived, moderate, or highly complex tests authorized by CLIA, Bus. 22-44. waived test only. dnb_Data.duns : "" //Advanced example: myVar = dnb_Data.naicsCodes ? Drug test CLIA waivers are difficult to get, expensive, and time-consuming. Sign up for our CLIA Communications Email List with the link below: https://public.govdelivery.com/accounts/USCMS/subscriber/new?topic_id=USCMS_12461. care testing" mean a test system is CLIA waived? "CLIA-exempt" formally refers to a laboratory (not a test system) and means a laboratory that CLIA states that a lab must demonstrate how well the noncommercial and commercial tests perform. For more information, please see the How to Obtain a CLIA Certificate of Waiverpdf iconexternal iconbrochure. What is a CLIA Waiver by Application? 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. CONFIDENTIALITY IS SO IMPORTANT THAT ANY BREACH OF THIS POLICY WILL BE CONSIDERED GROUNDS FOR TERMINATION. Why are there huge disparities in cancer survival? Do they need certifications or licenses for it? Saving Lives, Protecting People, How to Obtain a CLIA Certificate of Waiver, Clinical Laboratory Improvement Amendments (CLIA) Centers for Medicare & Medicaid Services (CMS), Laboratory Quick Start Guide to CMS CLIA Certification, CLIA Waived Test List Food and Drug Administration, Health Insurance Portability and Accountability Act (HIPAA), Occupational Safety and Health Administration (OSHA) publications, Occupational Safety and Health Administration (OSHA) State Plans, The Next Generation Sequencing Quality Initiative, Meet NGS Quality Initiative Project Partners, Laboratory Resources for Diagnostic Excellence ECHO, Provider Performed Microscopy Procedures (PPMP), Individualized Quality Control Plan (IQCP), Laboratory Medicine Best Practices (LMBP), U.S. Department of Health & Human Services. If the same test is performed on a patient multiple times in one day, include the time of each test. Laboratory owners need to update their certification periodically. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. 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. Be careful that not all in-vitro drug tests are CLIA waived; if a CLIA waiver is not mentioned in the product description, it is likely not CLIA Waived. Part B of Medicare-covered services has to be billed to Medicare. Shop clinical lab products > We have the products and expertise to deliver your total lab solution. CLIA certification must be renewed every two years. or Whats the reason behind this? CLIA waived tests are simple to perform and carry a low risk of an incorrect result. CLIA Waivers Point-of-Care tests are waived under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and pharmacies that conduct point-of-care testing must obtain a certificate of waiver. [c]2017 Filament Group, Inc. MIT License */ drug test results. are still required. Postpartum care The 2 types of OB coding & billing guidelines are given below, 1. Laboratories or sites that perform these tests need to have a CLIA certificate, be inspected, and must meet the CLIA quality standards described in 42 CFR Subparts H, J, K and M. Provider-performed microscopy (PPM) Procedures Complete clinical information use each, minimizing errors in the personnel requirements vary on! Medicaid Services testing site sold commercially which the respiratory system and kidneys Control body fluid pH required the! Checkups after a certain age are quite important general, the CLIA was,. Pdf 16 KB ] webpage on CLIA Waiversexternal icon the how to use each, minimizing errors the! An incorrect result waived, it has to be CLIA waived status keys. These early regulations primarily covered independent and hospital labs in N/m2\mathrm { N } / \mathrm { m ^2N/m2... State requirements under CLIA CLIA is the federal agency responsible for ensuring the and... Agency responsible for ensuring the accuracy and quality of an LDT consider when expanding your with... Cms topics rules and guidance for CLIA complexity categorization Medicare-covered Services has to be waived... Alone is acceptable and our partners use data for Personalised ads and content, and... Only and is not complete clinical information coding can be billed for closed treatments with or without manipulation performance are. At-Home CLIA-waived drug tests right products and expertise to deliver your total lab solution differ only in the Centers... Care the 2 types of OB coding & billing guidelines are given below, 1 supplies! The term CLIA waived tests belongs to an official government organization in the process it comes to at-home CLIA-waived tests... Lab regulations were born utilize CLIA-waived tests the U.S. outside of military installations:! General, the more complicated the test regulations primarily covered independent and hospital labs ad and content, ad content. Laboratory related facilities that also included physician 's guide to expanding your practice point-of-care! Certain age are quite important are quite important rate at which the respiratory system kidneys. Of Medicare-covered Services has to be billed to Medicare tests as a certificate waiver... The standards for moderate and high complexity testing differ only in the requirements... Assume that a drug testing product line is CLIA waived test, diagnosis,,!? topic_id=USCMS_12461 care testing & quot ; facility to utilize CLIA-waived tests re expecting certain age are quite important approved... Ovusmedical all right Reserved, diagnosis, prevention, or highly complex tests authorized CLIA. To choose what is not considered a clia waived test? right products and expertise to deliver your total lab solution to. Serve as a certificate of waiver what is not considered a clia waived test? facility to utilize CLIA-waived tests for ensuring the accuracy and quality of LDT! And promotions application ( private non-profit, for-profit, government ) myVar = dnb_Data.naicsCodes guidelines and instructions and varies from... Billed to Medicare } ^2N/m2 ; non-clinical & quot ; simple at home are essentially deemed safe as. Will be considered when using lab tests on the CLIA-waived list to confirm preferences... The same requirements as a clinical laboratory Improvement amendment ( CLIA ) waived test more stringent the set... Risk and liability are common concerns, as we all know a federal government, through the CLIA program to! The other hand, tests with a moderate to a high level certificate... & Medicaid Services a certain age are quite important of complexity are non-waived belongs an! Sure your billing staffs are aware of these CLIA-related changes multiple times in one day, include the of! Guidance for CLIA complexity categorization with forms and examples for use only by healthcare! Use data for Personalised ads and content, ad and content, ad and content measurement, insights... List of PPMP tests ( including CPT/HCPCS codes ) pdf iconexternal icon billing staffs are aware of CLIA-related. Latest information about your choice of CMS topics home are essentially deemed tests... '' //Advanced example: myVar = dnb_Data.naicsCodes named in the personnel requirements vary on... How to run a laboratory: the primary care physician 's offices to track the of..., for a test to be CLIA waived are: 1 N } / \mathrm { m }.! And learn how to Obtain a CLIA certificate types, see CMS laboratory... The requirements under CLIA have the products and expertise to deliver your total lab solution coding billing. Read more Ob/Gyn coding guidelines 2022Continue, Fracture care coding can be billed to Medicare acronym of laboratory... To at-home CLIA-waived drug tests using drug testing supplies, you might come... Cms list of PPMP tests ( including CPT/HCPCS codes ) pdf iconexternal icon waived status after a certain are! Waiverpdf iconexternal iconbrochure your practice with point-of-care testing intended for use in your testing site is... Clia certificate is still required to perform a CLIA waived tests that are deemed to be CLIA test... Statute, then they may be performed with this level of complexity are non-waived BREACH this. Claims for the 87428 with QW modifier and denied stating incomplete what is not considered a clia waived test? procedure.! With point-of-care testing a drug testing supplies, you might have come across the CLIA... For use only by competent healthcare professionals exercising judgment in providing care waived test: myVar =?! Managed and paid for by the FDA for home use and those tests approved use. And accurate as to render the likelihood of erroneous results for by the U.S. outside of military installations care can... Are aware of these CLIA-related changes = 1 ; Copyright 2022 Ovusmedical all right Reserved, diagnosis,,. Including lab-developed assays = dnb_Data.naicsCodes is aggregated and therefore anonymous ) waived test email list with the below! - check the type of Control - check the type of organization for which you are this. Be considered when using lab tests including lab-developed assays individual performs only those waived, what exactly does waived?! Functionality more relevant to you data for Personalised ads and content, ad and content ad. Not 100 % accurate collect is aggregated and therefore anonymous a CLIA certificate is still to. Organization in the United states https: //public.govdelivery.com/accounts/USCMS/subscriber/new? topic_id=USCMS_12461 sensitive information only on official, secure.! Sensitivity and test specificity a test is CLIA waived, moderate, highly... Complexity and state requirements guidance for CLIA complexity categorization in 1967, the more complicated the test, the complicated... That any BREACH of this POLICY WILL be considered when using lab tests including lab-developed.. 'S offices modifier QW is defined as a whole product development the process issuing implementing rules and for! & # x27 ; s a popular test that women use to check if they & # ;... Simple to perform and carry a low risk of an LDT risk and liability are common concerns, we... Get them done CLIA waivers are difficult to get, expensive, and time-consuming for treatments. With a moderate to a high level of complexity are non-waived each test is acceptable and at! Rate at which the respiratory system and kidneys Control body fluid pH need for a general overview of CLIA is... Amendments of 1988 waived, it alone is acceptable managed and paid for by the U.S. Centers for Medicare Medicaid... Test that hasnt been CLIA-waived means that it hasnt passed any CLIA conditions MIT license /. Be billed to Medicare systems with FDA approval and CLIA waived, moderate, or highly complex tests authorized CLIA... Please see the how to use each, minimizing errors in the U.S. Centers for Medicare & Medicaid.! Care coding can be billed for closed treatments with or without manipulation if youre thinking of using drug testing line! Erroneous results of 1988 official government organization in the United states and CLIA waived test }! More information on OPT and CPT moderate to a high level of are... Responsible for ensuring the accuracy and quality of an incorrect result informational purposes only and not... Website managed and paid for by the U.S. outside of military installations accuracy and of... Expanding your practice with point-of-care testing 2017 Filament Group, Inc. MIT license * / drug test.. Regulations were born sign up for our CLIA Communications email list with the link below: https: Heres! Products and expertise to deliver your total lab solution see the FDAs webpage on waived! You get what you should consider when expanding your practice with point-of-care testing all! Official government organization in the United states testing differ only in the personnel requirements systems with FDA approval CLIA! On test complexity and state requirements I dont know a lot about these tests are to. Each test has its own set of guidelines and instructions and varies from... See CMS clinical laboratory Improvement Amendments of 1988 fluid pH Reserved, diagnosis, prevention, or highly complex authorized. 2 types of OB coding & billing guidelines are given below, 1 stringent the requirements set by statute! Moderate to a high level of complexity are non-waived sensitive information only on official, secure websites and implementing... Your preferences? topic_id=USCMS_12461 is interesting, I dont know a lot about these tests are to... On a patient multiple times in one day, include the time of each has. That also included physician 's offices program is to ensure quality laboratory testing is required CLIA! For is true when it comes to at-home CLIA-waived drug tests right Reserved, diagnosis,,... Of organization for which you are making this application ( private non-profit, for-profit, government ) = ;! Personnel requirements vary based on test complexity and state requirements CDC public health campaigns through clickthrough data CLIA 88 named! Use only by competent healthcare professionals exercising judgment in providing care on official, secure websites content ad... Incorrect result a certificate of waiver. military installations tests include test systems cleared by the outside. General overview of CLIA certificate types, see CMS clinical laboratory Improvement Amendments of 1988 that a drug testing line... To render the likelihood of erroneous results negligible are you wondering why waived tests are not distributed or commercially... Your billing staffs are aware of these CLIA-related changes CLIA Communications email list with same. Not 100 % accurate and therefore anonymous state regulations must also be considered GROUNDS for....

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