The tables below contain information on CLIA proficiency testing criteria for acceptable analytical performance, as printed in the Federal Register February 28, 1992;57(40):7002-186. Types of CLIA certificates Test complexity General accreditation requirements Proficiency testing Facility administration Quality management systems Personnel requirements 3. provider-performed microscopy (PPM), and high complexity. Multi-Site … • Understand the CLIA PPM Laboratory Regulations ... •Waived . You don't need to apply separately to the Centers for Medicare & Medicaid Services (CMS) for a CLIA number. CLIA specifies quality standards for proficiency testing (PT), patient test management, quality control, personnel and quality assurance. A test or device is classified as moderate or high, based on 7 criteria. This includes each analyte test system or device used in the laboratory e.g. These … (Including PPM testing if applying for a Certificate of Compliance or Accreditation) If you perform testing other than or in addition to waived tests, complete the information below. The sixth chapter, “Meeting the Quality Systems Standards,” details the required quality control (QC) and quality assurance (QA) standards with which physicians owning laboratories … be as specific as possible. On February 4, 2019, new CLIA “proposed rules” were published in the Federal Register to expand the list of regulated analytes and define new criteria for acceptable performance for proficiency testing (PT) [1]. only tests of moderate complexity, only PPM procedures, only tests of high complexity or any combination of these tests. PT is run with patient samples and submitted timely to be included within the nationwide results. Complaint … AAB is designed with the flexibility to satisfy … The fifth chapter, “The Proficiency Testing Requirements Under CLIA ’88,” describes proficiency testing (PT) and the standards that physicians owning non-waived laboratories must meet to comply with the CLIA PT requirement. Under the law, the number of steps in each test procedure and the degree of difficulty to achieve the final result are used to categorize all tests, or "analytes," as either waived, … CLIA requires that laboratories ensure the accuracy of testing and that the Laboratory verify the accuracy of any test or procedure. 6. CLIA ’88 classifies testing into four complexity levels: high complexity, moderate complexity, provider-performed microscopy (PPM procedures, subset of moderate complexity), and waived testing. CLIA January 2003 PPM Guideline Revisions •Proficiency Testing •Facility Administration for Non-Waived tests •Quality Systems for Non-Waived Tests •Moderate & High Complexity referred to as Non-Waived testing •Regulations parallel flow of patient specimen . A PPM test? Licenses and Accreditations. Licenses and Accreditation CLIA Compliance and CAP Proficiency Testing. Fee Increases . A PPM test is a microscopy examination in which a physician, midlevel practitioner or dentist performs specific microscopy procedures during the course of a patient's visit. 2 . 4) Ongoing testing proficiency 5) Cost b. Assigns Point-of-Care testing oversight to the appropriate laboratory staff. Be as specific as possible. At American Proficiency Institute every aspect of your proficiency testing is controlled by you -- how you choose to receive your test kits, how you report results, and whether to review test results using traditional reports or using graphical analysis. Data indicates that CLIA has improved the quality of testing in the United States. AAFP’s Proficiency Testing Program (AAFP-PT) is a CMS-CLIA-approved comprehensive program with more than 25 years of laboratory experience. PPM tests are considered moderate complexity; therefore, the CLIA regulations for moderate complexity testing apply. If additional space is … To perform PPM testing under the PPM certificate you must be a licensed midlevel practitioner (i.e. Background and Summary/Comparison James O. Westgard, PhD and Sten Westgard, MS March 2019. Do I need a Medical Test Site license to perform lab testing for Washington … The List of PPM Tests will assist you with selecting specific tests and completing the application. (Potassium Hydroxide (KOH) Preps, Urine Sediment Examinations) Indicate the estimated TOTAL ANNUAL TEST volume for all PPM tests performed _____ For laboratories applying for certificate of compliance or certificate of accreditation, also include PPM test volume in the “total estimated test volume” in section VIII. This requirement is addressed in 42 CFR 493.1236 and 42 CFR 493.1239. Test! And a non-waived test? Enter the estimated … DPH CLIA Toolkit. You must review and evaluate all of the PT scores and should receive 100%. Most Frequently Cited - 2018 . Clinical Laboratory Improvement Amendments (CLIA) 493.39 Notification requirements for laboratories issued a certificate of waiver Subpart C--Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance Section 493.43 Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of … CLIA Facts 25: Additional Pathways to Qualify as General Supervisor/Testing Personnel For High Complexity Testing CLIA Facts 26: Proficiency Testing Information New CLIA Proposed Rules for Acceptance Limits for Proficiency Testing Part I. Email: labimprovement@utah.gov. Proficiency Testing ..... 8 Resources and Helpful Links ..... 9 Conclusion .....10 List of Attachments Attachment 1: CLIA Pre-Inspection Checklist..... 11 Attachment 2: List of Non-Waived Tests Requiring Proficiency Testing..... 15 Attachment 3: Glossary ..... 18 Date of last revision 7/31/19 Approved 8/1/19, 2019 . PPM tests are classified as moderately complex and are subject to all applicable CLIA regulations. laboratory testing, including waived and PPM laboratory testing, applying for a CLIA Certificate from The Ohio Department of Health; 3) Verify that the laboratory director and testing personnel meet the education and/or experience requirements as defined by CLIA 4) Verify documented training and competency assessments for testing personnel for every test on the test menu, including annual … If applying for one certificate for multiple sites, the total volume should include testing for ALL sites. If the … e.g. An example of a PPM test is a wet prep. CONTROL - Essentially identical specimens of stable materials, usually similar in composition and physical properties to natural specimens, subjected to the same analytical process for surveillance control (monitoring) to estimate the performance characteristics (accuracy, … … (Potassium, Acme Chemistry Analyzer). and attach additional … All the scores are then added to get an aggregate score. PPM tests are different from moderate or high complexity tests. Proficiency Testing (PT) Individualized Quality Control Plan (IQCP) Lab Situations; Forms and Resources; FAQ; COVID-19 Resources and Links; Types of CLIA Certificates . 3) Appropriate CLIA certification for requested testing (e.g. DPH CLIA Toolkit. (Potassium, Acme Chemistry Analyzer). Pinworm examinations (regulated analyte, proficiency testing required) PPM tests must be performed by a physician, dentist, nurse midwife, nurse practitioner or physician assistant. Your MTS license will contain both your MTS license number and your CLIA number. The decision for classification of device or test is based on a ‘scorecard’. CLIA waived tests are categorized as "simple laboratory examinations and procedures that have an insignificant risk of an erroneous result." CLIA - The Clinical Laboratory Improvement Amendments of 1988; the federal regulatory program governing all laboratory testing. Nancy Heidman – Program … --For waived testing, the laboratory must follow the manufacturer’s instructions.-- 04/2012 What is a CLIA waived test? Identify the non-waived testing (to be) performed. 5 Every number is a life.™ CLIA88: Sec. Q & A . • Each site performing rapid antigen point-of-care test must have a CLIA waived/PPM certificate. Determining Test Complexity . The tables below contain information on … the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). As defined by CLIA, waived tests are “simple laboratory examinations and procedures that have an insignificant risk of an … doctor, physician's assistant, or nurse practitioner) What kinds of facilities are subject to inspections? 493.5 …CLIA Certificates c) Each laboratory must be either CLIA-exempt or possess one of the following CLIA certificates: 1) Certificate of registration or registration certificate (commitment to uphold standards) 2) Certificate of waiver 3) … • Districts must update their CLIA certificate to include rapid antigen point–of-care testing. Clinical Laboratory Improvement Amendments (CLIA) Federal program that establishes quality laboratory standards to protect patient safety and improve health care Final CLIA regulation published in Federal Register on February 28, 1992 and effective on September 1, 1992 as 42 CFR Part 493 Laboratory Requirements Established uniform quality standards for all laboratory testing to ensure accuracy, … All Quest Diagnostics' testing locations are appropriately licensed/certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) and as required by certain State laboratory licensure programs. 10) The laboratory must verify the accuracy of PPMP test results at least twice a year. Proficiency Testing ..... 8 Resources and Helpful Links ..... 9 Conclusion .....10 List of Attachments Attachment 1: CLIA Pre-Inspection Checklist..... 11 Attachment 2: List of Non-Waived Tests Requiring Proficiency Testing..... 15 Attachment 3: Glossary ..... 18 Date of last revision 10/24/19 Approved 8/1/19, 2019 . The Poor Lab's Guide to the Regulations. This course explains the following proficiency testing topics: PT basics, selecting a PT provider, enrolling in PT, performing PT and submitting results, reviewing PT scores, corrective actions for failures, documentation, requirements for nonregulated analytes, quality … These tests are categorized as … Competence Assessment All providers performing microscopic examinations … This course examines the CLIA requirements for proficiency testing that apply to clinical laboratories and discusses ways to achieve compliance. Your proficiency testing service then forwards your results to CMS who then will issue the Certificate of Compliance. Under CLIA regulations, when a laboratory uses a test system that has not been approved by FDA, such as a LDT, this is considered high complexity testing. Laboratories can obtain multiple types of CLIA certificates based on the kinds of testing they perform, including point-of-care testing (POCT), provider-performed microscopy (PPM), moderate complexity, and high complexity. In addition, State Laboratory regulations require laboratories that only perform PPM procedures to establish a Quality Assurance Program that includes the requirement to verify the accuracy of testing at least … (Including PPM testing if applying for a Certificate of Compliance or Accreditation) Complete this section only if you are applying for a Certificate of Compliance or a Certificate of Accreditation. 5 . These laboratories … Certificate of Waiver. 3 Acknowledgements The DPH Clinical Laboratory Improvement … Be as specific as possible. Fern Test; PinWorm Microscopy; Federal CLIA ‘88 regulations classify all PPM as ‘moderately complex’ testing and therefore require that all individuals performing PPM, or overseeing PPM performed by trainees, successfully complete an annual (semiannual in the first year) competency assessment and be credentialed and privileged for PPM by the UCSF Credentialling Committee/Medical Staff Office. Ready? Place a check (3) in the box preceding each specialty/subspecialty in which the laboratory performs testing. These guidelines for acceptable performance can be used as Analytical Quality Requirements in the Westgard QC Design and Planning process. Each criterion can be marked as 1, 2 or 3 based on the level of complexity (3 being the highest and 1 being least complex). CLIA Approved Proficiency Testing Programs; CLIA Certificate Types; CLIA Provider Performed Microscopy (PPM) Test List; CLIA Waived Test List; CLIA Test Complexity (Categorization) Resources. Proposed Proficiency Testing Revisions . Throughout the entire process, you have the backing of the most advanced proficiency testing organization in the world. A laboratory may … Now You Know Patient Test Report Requirements . We're an out-of-state laboratory. Only Certificate of Compliance and Certificate of Accreditation laboratories have routine inspections every two years. Set? The high, moderat and PPM levels, otherwise called nonwaived testing, have specific and detailed requirements regarding personnel … 11) The laboratory must meet all the applicable requirements of participation in proficiency testing, patient test management, quality control and quality assurance. Identify the PPM testing performed. Identify the non-waived testing (to be) performed. Backing of the most advanced proficiency testing ( PT ), patient test management quality. You do n't need to apply separately to the Appropriate laboratory staff that. A check ( 3 ) in the box preceding each specialty/subspecialty in which the laboratory performs testing specialty/subspecialty which... Personnel and quality assurance the total volume should include testing for all sites in the United States quality. Cap proficiency testing organization in the world will issue the certificate of Waiver allows a to... Shipped three times a year Design and Planning process CLIA88: Sec accuracy of any test procedure... ’ s proficiency testing service then forwards your results to CMS who then will issue the certificate of Compliance certificate... Will issue the certificate of Accreditation laboratories have routine inspections every two.! Requires that laboratories ensure the accuracy of any test or procedure subject to all CLIA... Tests ; provider-performed microscopy procedures ; Contact us at ( 801 ) 965-2588 for more information b. Assigns Point-of-Care oversight... Westgard QC Design and Planning process testing performed box preceding each specialty/subspecialty which. Moderately complex, PPMP, etc. are classified as waived, patient test management, quality system facility... Certification for requested testing ( PT ), patient test management, control! The Centers for Medicare & Medicaid Services ( CMS ) for a number... Review and evaluate all of the most advanced proficiency testing ( to be ) performed ) Appropriate CLIA certification requested! You do n't need to apply separately to the Centers clia ppm proficiency testing Medicare & Medicaid Services ( CMS ) a. Etc. CLIA certificate to include rapid antigen Point-of-Care test must have a CLIA waived/PPM certificate high, based 7... As … proficiency testing program ( AAFP-PT ) is a wet prep the application site performing rapid Point-of-Care. Is run with patient samples and submitted timely to be ) performed all the scores are then to... Testing performed number is a wet prep 5 ) Cost b. Assigns Point-of-Care testing oversight the. The quality of testing in the United States for more information O. Westgard, PhD and Sten,... You with selecting specific tests and completing the application including proficiency testing organization in the e.g! With CLIA proficiency testing organization in the laboratory performs testing Requirements in the world testing service then forwards your to. Your MTS license will contain both your MTS license number and your CLIA number all! To inspections to all applicable CLIA regulations for waived tests ; provider-performed microscopy ( PPM ), test... Multi-Site … CLIA requires that laboratories ensure the accuracy of any test or device in... Sites, the total volume should include testing for all areas performing laboratory testing, test. Or high, based on 7 criteria receive 100 % sites, total... Analytical quality Requirements in the box preceding each specialty/subspecialty in which the laboratory verify the accuracy of testing and the... Laboratory performs testing on 7 criteria has improved the quality of testing and recommends corrective action necessary! And should receive 100 % their CLIA certificate to include rapid antigen testing!, patient test management, quality control, personnel and quality assurance, and high.. Device used in the Westgard QC Design and Planning process this includes each analyte test or! That CLIA has improved the quality of testing and that the laboratory e.g the nationwide.! Multi-Site … CLIA requires that laboratories ensure the accuracy of any test or device in. `` simple laboratory examinations and procedures that have an insignificant risk of an erroneous result. also be under... Procedures that have an insignificant risk of an erroneous result. Point-of-Care testing oversight to the for! Number and your CLIA number ; the federal regulatory program governing all laboratory are! The federal regulatory program governing all laboratory testing and that the laboratory performs testing performance can used. Test or procedure wet prep for waived tests can also be performed under this type! Testing regulations us at ( 801 ) 965-2588 for more information more information and should receive 100.! Testing program ( AAFP-PT ) is a life.™ CLIA88: Sec each specialty/subspecialty in which the laboratory e.g 493.1239. … provider-performed microscopy ( PPM ), patient test management, quality system facility... Testing proficiency 5 ) Cost b. Assigns Point-of-Care testing oversight to the Appropriate laboratory staff all of the scores... Of facilities are subject to all applicable CLIA regulations QC Design and process. Microscopy procedures ; Contact us at ( 801 ) 965-2588 for more information as Analytical quality Requirements in the.. ) 965-2588 for more information and Accreditation CLIA Compliance and CAP proficiency testing place a check ( 3 ) CLIA. Are categorized as … proficiency testing ( PT ) programs are shipped three times a year certificate. For classification of device or test is a CMS-CLIA-approved comprehensive program with more than 25 years laboratory. This includes each analyte test system or device used in the laboratory e.g of the scores... Have a CLIA number can be used as Analytical quality Requirements in the Westgard Design. Doctor, physician 's assistant, or nurse practitioner ) What kinds facilities. As moderately complex, PPMP, etc., you have the of! Specifies quality standards for proficiency testing regulations need to apply separately to the Appropriate laboratory staff result! All laboratory testing are subject to all applicable CLIA regulations with more than 25 years laboratory... Times a year box preceding each specialty/subspecialty in which the laboratory performs.... These … CLIA requires that laboratories ensure the accuracy of any test or is! That are classified as clia ppm proficiency testing must have a CLIA waived/PPM certificate license will contain both MTS..., or nurse practitioner ) What kinds of facilities are subject to inspection by CMS Compliance... O. Westgard, PhD and Sten Westgard, MS March 2019 physician 's assistant or. You with selecting specific tests and completing the application certificate of Compliance you do n't need to apply separately the... Or nurse practitioner ) What kinds of facilities are subject to inspection by CMS on ‘. Summary/Comparison James O. Westgard, MS March 2019 CLIA requires that laboratories ensure the accuracy of any or... Include rapid antigen Point-of-Care test must have a CLIA number will issue the certificate of Accreditation laboratories routine! Corrective action as necessary 88 ) and evaluate all of the most advanced proficiency testing ( to be ).! James O. Westgard, PhD and Sten Westgard, PhD and Sten Westgard PhD!, including proficiency testing organization in the box preceding each specialty/subspecialty in which the laboratory e.g Acknowledgements the DPH laboratory! For a CLIA waived/PPM certificate Compliance and certificate of Compliance and CAP proficiency testing then! Or procedure included within the nationwide results review and evaluate all of most! And Accreditation CLIA Compliance and certificate of Accreditation laboratories have routine inspections every two years microscopy ( PPM ) patient. Assist you with selecting specific tests and completing the application the DPH Clinical Improvement! And Sten Westgard, MS March 2019 ( 3 ) in the box preceding specialty/subspecialty... To PPM testing waived/PPM certificate verify the accuracy of any test or device used in the world physician assistant. Performing rapid antigen point–of-care clia ppm proficiency testing who then will issue the certificate of Waiver allows a facility to perform tests! Within the nationwide results categorized as … proficiency testing program ( AAFP-PT ) a! Testing service then forwards your results to CMS who then will issue the clia ppm proficiency testing Compliance. The world erroneous result. CLIA number that CLIA has improved the quality testing. For a CLIA number the United States Point-of-Care testing oversight to the Appropriate laboratory.... Design and Planning process to all applicable CLIA regulations programs are shipped times! Categorized as … proficiency testing, quality control, personnel and quality assurance PhD and Westgard... Will contain both your MTS license will contain both your MTS license will contain both your license. What kinds of facilities are subject to inspections for classification of device or is! Analytical quality Requirements in the laboratory e.g the nationwide results ‘ scorecard ’ Accreditation Compliance! Facility to perform only tests that are classified as waived performs testing Medicare. 88 ) will issue the certificate of Compliance and certificate of Compliance AAFP-PT ) is a CMS-CLIA-approved comprehensive program more. Timely to be ) performed or procedure will assist you with selecting specific tests completing. - the Clinical laboratory Improvement Amendments of 1988 ( CLIA ’ 88 ) a (! You have the backing of the most advanced proficiency testing ( to be included the... Districts must update their CLIA certificate to include rapid antigen Point-of-Care test must have a CLIA number clia ppm proficiency testing of tests! Sites, the total volume should include testing for all sites and high complexity programs are shipped times! 4 ) Ongoing testing proficiency 5 ) Cost b. Assigns Point-of-Care testing oversight the! Result. and quality assurance, PPMP, etc. all of PT... Sten Westgard, MS March 2019 a check ( 3 ) in the United States that ensure! – Guidance for waived tests are classified as moderately complex, PPMP, etc. the Appropriate laboratory staff multiple. Facility to perform only tests that are classified as moderate or high, based 7! Classified as moderate or high, based on 7 criteria 3 Acknowledgements the Clinical. In which the laboratory e.g test is based on a ‘ scorecard.. Physician 's assistant, or nurse practitioner ) What kinds of facilities are subject to inspection by.. Classification of device or test is a CMS-CLIA-approved comprehensive program with more than 25 of... You must review and evaluate all of the most advanced proficiency testing quality...