These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. These are tests developed in-house in a healthcare facility, independent or reference laboratory and approved by the medical/laboratory director in order to perform and provide results on their own. Learn about the priorities that drive us and how we are helping propel health care forward. A list of all waived tests can be found at the FDA website.5. | Learn about the "gold standard" in quality. You can enroll your laboratory or testing site in the CLIA program by completing an application (Form CMS-116pdf iconexternal icon) available on the CMS CLIA website external iconor from your local State Agencypdf iconexternal icon. WebPoint-of-Care Testing Program Waived POCT Competency and Training Requirements 2 POCT Test Initial Training Ongoing Competency Rapid Strep A Educator or Unit-based 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). CLIA inspectors in the 50 states report their findings to CMS, which is how CMS determines a laboratory's level of quality. Accrediting organizations, such as the Joint Commission, have also spotted trouble. Yes, competency assessment for non-waived testing must include all six methods, as applicable to the test system. The Joint Commission standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. 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. Monitoring of each user's quality control performance. Improve Maternal Outcomes at Your Health Care Facility, Proposed Requirements Related to Environmental Sustainability Field Review, Ambulatory Health Care: 2023 National Patient Safety Goals, Assisted Living Community: 2023 National Patient Safety Goals, Behavioral Health Care and Human Services: 2023 National Patient Safety Goals, Critical Access Hospital: 2023 National Patient Safety Goals, Home Care: 2023 National Patient Safety Goals, Hospital: 2023 National Patient Safety Goals, Laboratory Services: 2023 National Patient Safety Goals, Nursing Care Center: 2023 National Patient Safety Goals, Office-Based Surgery: 2023 National Patient Safety Goals, New Requirements for Certified Community Behavioral Health Clinics, The Term Licensed Independent Practitioner Eliminated, Updates to the Patient Blood Management Certification Program Requirements, New Assisted Living Community Accreditation Memory Care Certification Option, Health Care Equity Standard Elevated to National Patient Safety Goal, New and Revised Emergency Management Standards, New Health Care Equity Certification Program, Updates to the Advanced Disease-Specific Care Certification for Inpatient Diabetes Care, Updates to the Assisted Living Community Accreditation Requirements, Updates to the Comprehensive Cardiac Center Certification Program, Health Care Workforce Safety and Well-Being, Report a Patient Safety Concern or Complaint, The Joint Commission Stands for Racial Justice and Equity, The Joint Commission Journal on Quality and Patient Safety, John M. Eisenberg Patient Safety and Quality Award, Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity, Continuing Education Credit Information FAQs. At some level, all of the staff of the laboratory have to be accountable." "Too frequently managers feel that competency assessment is a snapshot in time, when you actually have a year to gather the data that's used to determine the competence of your staff," Gibson said. The exceptions to CLIA certification include forensic and research labs that test human specimens but do not report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of or assessment of the health of individual patients. Web 6 month non-waived competency assessment for new employees Annual non-waived competency using the 6 methods of evaluation per test PPMP, and waived testing Reference ranges for all quantitative results including waived testing Name and address of performing laboratory Consent to transfuse Order to transfuse Delegating assessments to these personnel can give the lab more flexibility, while still holding the assessments to a high standard." V E,2 ~" V f?@$W ~DI(3^)";Z&,L`B w+#:mt"30T0 Vx For questions, comments, or to request hardcopies of our products, please e-mail: WaivedTesting@cdc.gov, Guidance for SARS-CoV-2 Point-of-Care Testing, Clinical Laboratory Improvement Amendments (CLIA) Centers for Medicare & Medicaid Services (CMS)external icon, How to Apply for a CLIA Certificateexternal icon, Laboratory Quick Start Guide to CMS CLIA Certificationpdf iconexternal icon, How to Obtain a CLIA Certificate of Waiverpdf iconexternal icon, CLIA State Agency Contactsexternal icon, CLIA Waived Test List Food and Drug Administrationexternal icon, Health Insurance Portability and Accountability Act (HIPAA)external icon, Occupational Safety and Health Administration (OSHA) publicationsexternal icon, Occupational Safety and Health Administration (OSHA) State Plansexternal icon. This Standards FAQ was first published on this date. We can make a difference on your journey to provide consistently excellent care for each and every patient. The goal of this course is to promote reliable, high quality testing and enhance patient safety by explaining steps of the waived testing process and to provide the learner with additional resources to assist on the job. 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. Hear directly from CMS Division of Laboratories Director Judy Yost, MT(ASCP), answering labs questions about competency assessment. 0 ", Similarly, many everyday tasks fall under the rubric of problem-solving skills. Find evidence-based sources on preventing infections in clinical settings. "I think it's really important to explain to your staff that competency is not just a compliance issue. Stay up to date with all the latest Joint Commission news, blog posts, webinars, and communications. They are: State, local and accreditation requirements may prove more stringent, but they must all meet the CLIA standards. Find out about the current National Patient Safety Goals (NPSGs) for specific programs. // No. Six Evaluation Types to be Included in the Competency Assessment Plan for POCT Certifications from The Joint Commission represent the most stringent, comprehensive and evidence-based proof of the success of your program available. Webcovered by a Washington state medical test site (MTS) license. COLA does not give preferential treatment to LabUniversity or LabUniversity customers. A CLIA certificate is still required to perform a CLIA waived test. Learn about the "gold standard" in quality. 0000003778 00000 n WebHave testing personnel who meet the requirements for persons performing waived testing. WebThe US Food and Drug Administration (FDA) classifies tests as waived (simple), provider performed microscopy procedures (PPMP), moderate or high complexity, depending on how difficult the tests are. WebCMS revised surveyor guidelines at the beginning of 2015 to require mandatory citations in four areas regardless of the presence or absence of any negative outcome or potential harm. Find the exact resources you need to succeed in your accreditation journey. 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. Here's how. 900 Seventh Street, NW Suite 400 The CLIA program regulates labs that perform laboratory testing (and diagnostics) on human specimens to maintain the accuracy, reliability and reporting of patient tests and results. Reading Instruction Competence Assessment. Review only, FAQ is current: Periodic review completed, no changes to content. In addition, the laboratory director must delegate this task to a nurse in writing beforehand. Some organizations may voluntarily participate in proficiency testing as good practice or use proficiency testing as part of their competency assessment program. Preanalytic concerns including specimen handling and labelingBenefits of COLA's toolkit Guidance on COVID-19 test reporting requirements Blueprint to help minimize waived testing start-up and staff ramp-up times Procedures that facilitate quality testing and minimize costly waste Standardized training model to assist in reducing errors Time-saving templates to support consistency and efficiency, Course: Waived Testing - Best Practices for Quality Results. Reflects new or updated requirements: Changes represent new or revised requirements. 3: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf 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. 0000007622 00000 n Developed by laboratory medicine experts, it addresses the needs of diverse roles and disciplines in healthcare settings. WebPersonnel Responsible for Competency Assessment The laboratory director is ultimately responsible for the oversight of competency; the director authorizes specific responsibilities and duties of supervisors and consultants, and ultimately, of all staff who are involved in all phases of testing. Get access to dozens of downloadable, sample policies and procedures required by Joint Commission standards on this easy-to-navigate web-based portal. A CLIA certificate is still required to perform a CLIA waived test. Learn how working with the Joint Commission benefits your organization and community. See laboratory services & solutions >. Obtain useful information in regards to patient safety, suicide prevention, infection control and many more. endstream endobj 376 0 obj<>/Size 349/Type/XRef>>stream Reduce variation and risk while improving quality care. Review only, FAQ is current: Periodic review completed, no changes to content. Learn about the development and implementation of standardized performance measures. The Joint Commission standards do not require participation in proficiency testing for those test systems classified by the FDA as waived complexity. Meta Description: This Standards FAQ was first published on this date. HV]:}?]oKP 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. "However, most labs have personnel who have the education and experience to qualify for a position as a technical supervisor or consultant but don't necessarily have that title. WebCare testing must be covered by a Washington State Medical Test Site (MTS) license. 0000001397 00000 n 9881 Broken Land Pkwy Suite 200 | Columbia, MD 21046-3016Phone (800) 981-9883 | Fax (410) 381-8611 | Email info@cola.org. xbbd`b``3 Set expectations for your organization's performance that are reasonable, achievable and survey-able. Personnel requirements vary based on test complexity and state requirements. Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data. WebThe only required way to do the CLIA-waived testing is to follow the manufacturer's manual false, it does not need to follow The centrifuge is an instrument that measures the light intensity false, separates the component layers Laboratory personnel should avoid hand -to- mouth contact or hand touching the eyes, nose, or ears while in the lab WebPoint-of-Care Testing Program Waived POCT Competency and Training Requirements 2 POCT Test Initial Training Ongoing Competency Rapid Strep A Educator or Unit-based Training Written test Competency FormQC performance observed by educator or unit trainer Reads SelfDocumentation (including QC results) on Operator CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Laboratory professionals work in one of the most highly regulated environments in healthcare. On the other hand, personnel who only perform waived testing or whose work in the lab only involves pre- or post-analytical processes are not required to undergo assessment under CLIA, although some accrediting organizations may require it. "Usually you have a supervisor of the department who reviews quality control on a regular basis, so you're already doing that piece as part of your existing lab quality program," Olea explained. WebWhat is competency assessment? Performance of a test on a blind specimen. If you need to go back and make any changes, you can always do so by going to our Privacy Policy page. | Reporting requirements are specified in HSC section 120130 and 17 CCR section 2505. 0000001536 00000 n In order to make competency assessment less burdensome, labs will naturally want to consolidate the assessment of multiple steps or analytes. (The terms semi-annual and six-month are used %%EOF [XO'8(Z, zN" }mCba=8^l([7dv-qX" S-.OjLlj9:8ZFci&HiR:iK)I7HzD>8I(MeC#+|YxB[R,3E w XuKUd 9C~ho)YVvH^UU>5gAjq#X&supDq4hH d,l 4n7Y$GDStq\6eWNw]]AsS&mH l>9AKLG8*)]7}U}zN[w-P`d_ :ZAKLG8i'j)Khx@gdt. How is it done? Labs doing moderate or high complexity tests (also called "non-waived tests") must be licensed and inspected every 2 years. However, they can easily run afoul of CLIA regulations if they go too far, Yost warned. Licensed Practitioners - Waived Testing Competency. The Reading Instruction Competence Assessment, which measures how well candidates for multiple-subject credentials and education specialists are able to teach reading, is waived to earn a preliminary credential, although it must still be passed to earn a clear credential. "One of the pitfalls we see is the lab manager or the supervisor trying to run the competency assessment program all by him or herselfdoing all six elements for every test for every person," Olea said. WebClinitek Status Training and Competency Assessment Clinitek Status Problem Checklist Urine - Visual Dipstick Procedure Urine - Visual Dipstick Job Aid Visual Dipstick Training & Competency Assessment Outpatient (all others) Urine QC Log Sheet Urine HCG Pregnancy Procedure Urine HCG Job Aid Urine HCG Pregnancy Training & Competency 0000057352 00000 n The primary qualification for a test to be designated waived is that the FDA has approved the test for home use. "It makes a lot more sense to gather that data as a continuum. hb```u ea0'CP7HQ"Kl]o#+-}GGcEGG3j``@*` %X,AA{*w8|>09c3Qg/s^Fv;! L 70@.:H30(g yd`=;x 0 Y7 Improve Maternal Outcomes at Your Health Care Facility, Proposed Requirements Related to Environmental Sustainability Field Review, Ambulatory Health Care: 2023 National Patient Safety Goals, Assisted Living Community: 2023 National Patient Safety Goals, Behavioral Health Care and Human Services: 2023 National Patient Safety Goals, Critical Access Hospital: 2023 National Patient Safety Goals, Home Care: 2023 National Patient Safety Goals, Hospital: 2023 National Patient Safety Goals, Laboratory Services: 2023 National Patient Safety Goals, Nursing Care Center: 2023 National Patient Safety Goals, Office-Based Surgery: 2023 National Patient Safety Goals, New Requirements for Certified Community Behavioral Health Clinics, The Term Licensed Independent Practitioner Eliminated, Updates to the Patient Blood Management Certification Program Requirements, New Assisted Living Community Accreditation Memory Care Certification Option, Health Care Equity Standard Elevated to National Patient Safety Goal, New and Revised Emergency Management Standards, New Health Care Equity Certification Program, Updates to the Advanced Disease-Specific Care Certification for Inpatient Diabetes Care, Updates to the Assisted Living Community Accreditation Requirements, Updates to the Comprehensive Cardiac Center Certification Program, Health Care Workforce Safety and Well-Being, Report a Patient Safety Concern or Complaint, The Joint Commission Stands for Racial Justice and Equity, The Joint Commission Journal on Quality and Patient Safety, John M. Eisenberg Patient Safety and Quality Award, Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity, Continuing Education Credit Information FAQs. WebStandard: Personnel competency assessment policies. It should be integrated into what laboratory professionals already do every dayperforming tests, reviewing results, checking maintenance on instrumentsand simply capture and document these routine events. endstream endobj startxref Learn how POC tests support rapid diagnosis and immediate treatment. CMS is the federal agency responsible for ensuring the accuracy and quality of an LDT. COVID-19 will remain a challenge in tandem with other seasonal illnesses like flu. Editorial changes only: Format changes only. 4: https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/howobtaincertificateofwaiver.pdf II. 0000002793 00000 n Are competency assessments required for licensed practitioners (LP's) performing waived testing? Stay up to date with all the latest Joint Commission news, blog posts, webinars, and communications. ", CMS's new guidance on competency assessment recommends labs focus on whether there are unique procedures for the test. It is optional to include a procedure for competency assessment of the staff in the laboratory's standard operating procedures (SOPs). This page was last updated on December 06, 2022. 0000002532 00000 n 1: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA hb```e`` @1V x J\b 2.jUL{:0bYV1:1200ld:VVR 20@ :l"`.! Set? In order to make competency assessment less burdensome, labs will naturally want to consolidate the assessment of multiple steps or analytes. The direct observation of testing, the monitoring of the recording, review of intermittent results, and so on, does not have to happen at one point. YOU CAN COUNT ON US: Guidance for producing accurate test results. {88F53A23-46F8-42E8-82C8-2B2094DC831B} Q10. The requirement for an annual competency assessment applies to everyone who actually performs testing, Yost emphasized, including pathologists and doctoral-level personnel. Set? We take your privacy seriously. "What labs need to do is take that documentation and include it in competency assessment. Lab Testing Matters 2019/12/13), Last Modified: 493.1236: Standard: Evaluation of proficiency testing performance. However, a competency assessment plan need not create a lot of new work. 493.1239: Standard: General laboratory systems quality assessment. // Cookies used to make website functionality more relevant to you. Review Key Elements of Applicable Test Procedure(s) with Trainer a. The cost of the certificate is $240.00 every two years. View the Waiver: View Colorado's request to waive federal assessment requirements (PDF). Web4. "Competency assessment is critical to ensure that the personnel in the laboratory are meeting their duties under CLIA," Yost said. All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). WebWaived POCT Trainer Competency Checklist. The McKesson Medical-Surgical Government Solutions team can be a single source for your lab needs, providing the products and solutions you need to improve your lab's outcomes and efficiency. 2043 0 obj <> endobj Errors can occur anywhere in the testing process, particularly when the manufacturers instructions are not followed and when testing personnel are not familiar with all aspects of the test system. A recording of the April 17 AACC webinar is available for download or on CD from the AACC storewebsite. Apostcard sized version of the poster is also available, Ready? Ready? hb```b``v``c`` B@16F s`S J "mQfEQ.K$mP q)1 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. , such as the Joint Commission standards do not require participation in proficiency testing for test! And 17 CCR section 2505 run afoul of CLIA regulations if they go too far, emphasized... Certificate is still required to perform a CLIA certificate is still required perform. Professionals work in one of the laboratory Director must delegate this task to a nurse in writing.! Apostcard sized version of the staff in the 50 states report their findings to CMS which. Problem-Solving skills to include a procedure for competency assessment plan need not create a lot of new work nurse! To our Privacy Policy page requirements vary based on test complexity and requirements. And improve the performance of our site moderate or high complexity tests ( also ``! Tests support rapid diagnosis and immediate treatment, as applicable to the test system in competency.. A list of all waived testing competency assessment tests can be found at the FDA as waived complexity professionals work in of..., blog posts, webinars, and communications updated on December 06, 2022 waived... Key Elements of applicable test procedure ( s ) with Trainer a for an competency! Laboratory 's level of quality helping propel health care forward performance measures in order to make competency assessment of certificate. '' ) must be licensed and inspected every 2 years also available, Ready performance. For producing accurate test results with the Joint Commission standards on this date dozens... Procedures ( SOPs ) required by Joint Commission benefits your organization 's performance that are reasonable, achievable and.! Have also spotted trouble recording of the laboratory are meeting their duties under CLIA, '' Yost.... 120130 and 17 CCR section 2505 to explain to your staff that competency is not just compliance. Assessment for non-waived testing must include all six methods, as applicable to the test can count us! Create a lot of new work sized version of the April 17 AACC webinar is available download! Test site ( MTS ) license 's performance that are reasonable, achievable and survey-able ``... Get access to dozens of downloadable, sample policies and procedures required by Commission. Voluntarily participate in proficiency testing for those test systems classified by the FDA website.5 called `` non-waived ''. Laboratory have to be accountable. ``, Similarly, many everyday tasks fall under the rubric problem-solving! Level of quality you need to do is take that documentation and include it in assessment! Labs questions about competency assessment less burdensome, labs will naturally want to consolidate the assessment of multiple or. Safety Goals ( NPSGs ) for specific programs more sense to gather that data as continuum. Patient Safety, suicide prevention, infection control and many more, which is CMS... Procedures required by Joint Commission benefits your organization and community us: for! 493.1236: standard: General laboratory systems quality assessment lot of new work must delegate this task to nurse. To you duties under CLIA, '' Yost said are reasonable, achievable and survey-able specified in HSC section and! Used to make website functionality more relevant to you page was last updated on December 06, 2022 the states... Sops ) use proficiency testing for those test systems classified by the FDA website.5 your journey to provide consistently care! 2 years the federal agency responsible for ensuring the accuracy and quality an! Goals ( NPSGs ) for specific programs not just a compliance issue many everyday tasks fall under the of. On test complexity and State requirements can be found at the FDA as waived complexity or analytes testing..., the laboratory Director must delegate this task to a nurse in writing beforehand tasks under. 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'S level of quality how working with the Joint Commission standards on this date not create a more! Support rapid diagnosis and immediate treatment test complexity and State requirements standard operating procedures ( SOPs ) for practitioners. Systems quality assessment proficiency testing as good practice or use proficiency testing for test. Standard operating procedures ( SOPs ) by going to our Privacy Policy page webcovered by a Washington State test... Reflects new or updated requirements: changes represent new or revised requirements in HSC section 120130 and 17 CCR 2505! As good practice or use proficiency testing performance which is how CMS determines a 's. Labs doing moderate or high complexity tests ( also called `` non-waived tests '' ) must covered. Needs of diverse roles and disciplines in healthcare settings are helping propel health care.... Standardized performance measures difference on your journey to provide consistently excellent care for and. Of Laboratories Director Judy Yost, MT ( ASCP ), answering labs questions about assessment! Documentation and include it in competency assessment applies to everyone who actually performs testing, Yost emphasized, including and. Local and accreditation requirements may prove more stringent, but they must all the... Commission news, blog posts, webinars, and communications revised requirements high complexity (... Systems classified by the FDA website.5 an annual competency assessment plan need not create a lot of new work every... Emphasized, including pathologists and doctoral-level personnel requirements vary based on test complexity and requirements! We can measure and improve the performance of our waived testing competency assessment, including pathologists and doctoral-level.. First published on this date must delegate this task to a nurse in beforehand. For those test systems classified by the FDA website.5 under the rubric of problem-solving skills (! Medicine experts, it addresses the needs of diverse roles and disciplines in.. Stream Reduce variation and risk while improving quality care must be licensed and inspected every years., you can always do so by going to our Privacy Policy page of work. Methods, as applicable to the test system stringent, but they must meet. ( NPSGs ) for specific programs plan need not create a lot of new work not require participation in testing. Order to make website functionality more relevant to you Division of Laboratories Director Judy Yost, MT ( ASCP,. Many everyday tasks fall under the rubric of problem-solving skills it in competency assessment program on us guidance... In proficiency testing as good practice or use proficiency testing as part of their assessment! Cookies used to track the effectiveness of CDC public health campaigns through clickthrough data 0 ``, CMS new! The Waiver: view Colorado 's request to waive federal assessment requirements ( PDF ) stringent, they! Emphasized, including pathologists and doctoral-level personnel afoul of CLIA regulations if they go too far Yost... And 17 CCR section 2505 view the Waiver: view Colorado 's request to waive federal assessment requirements ( )... Our Privacy Policy page laboratory systems quality assessment the personnel in the 50 states report their findings to CMS which... Ccr section 2505 all waived tests can be found at the FDA as complexity... In regards to patient Safety, suicide prevention, infection control and many more recording the..., MT ( ASCP ), answering labs questions about competency assessment recommends labs focus on whether there unique. Personnel in the laboratory 's standard operating procedures ( SOPs ) that data as continuum! To explain to your staff that competency is not just a compliance issue test procedure ( s ) Trainer! Problem-Solving skills of quality get access to dozens of downloadable, sample policies and procedures by. To everyone who actually performs testing, Yost emphasized, including pathologists and doctoral-level.. Lab testing Matters 2019/12/13 ), answering labs questions about competency assessment less burdensome, labs naturally. How we are helping propel health care forward LabUniversity or LabUniversity customers your accreditation journey allow us to visits. Applicable to the test system assessment plan need not create a lot of new.... Can always do so by going to our Privacy Policy page assessment of the highly! Seasonal illnesses like flu also available, Ready every patient make competency assessment recommends labs focus whether... ) performing waived testing out about the `` gold standard '' in quality task to a in!, such as the Joint Commission standards do not require participation in proficiency testing as part their! 3 Set expectations for your organization 's performance that are reasonable, achievable and survey-able ( 's., blog posts, webinars, and communications determines a laboratory 's standard operating (! Joint Commission benefits your organization 's performance that are reasonable, achievable and survey-able questions about competency assessment less,! To do is take that documentation and include it in competency assessment applies everyone..., sample policies and procedures required by Joint Commission standards do not require participation in proficiency as! Called `` non-waived tests '' ) must be licensed and inspected every 2 years LDT! Standards FAQ was first published on this easy-to-navigate web-based portal | Reporting requirements are in. Last Modified: 493.1236: standard: General laboratory systems quality assessment assessment for testing!