from the Chaff Ellis Jacobs, Ph.D., DABCC, FAACC Principal, EJ - PowerPoint PPT Presentation

Weeding Through Waived Testing: Separating the Wheat from the Chaff Ellis Jacobs, Ph.D., DABCC, FAACC Principal, EJ Clinical Consulting, LLC Adjunct Associate Professor of Pathology, Mount Sinai School of Medicine

Agenda 1 Describe Overarching Federal Regulations/Role of Deemed Agencies 2 Review the Growth of POCT 3 Regulatory Deficiencies in Waived Testing 4 Personnel Training and Competency Assessment Requirements 5 Requirements for Assuring Quality of Examination Procedures 2

Clinical Laboratory Improvement Act of 1988 (CLIA 88) 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). • The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities. approximately 260,000 laboratory entities. 3

CLIA Test Complexity Criteria Knowledge Interpretation Training and Judgment Complexity Classification Maintenance Reagent and and Material Troubleshooting Preparation QA/QC Operational Characteristics Technique

CLIA Test Complexity Level CLIA High Moderate Waived PPMP Requirements Personnel Yes Yes No Yes QC/QA Practice Yes Yes As per Yes Manufacturer PT/EQA Yes Yes No If available Routine Yes Yes No No Inspections For-cause Yes Yes Yes Yes Inspections 5

CLIA Registered Laboratories https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020 6

CLIA Laboratory Certification (Non-Exempt) COW - 189,978 , PPM - 31,163, CC - 17,594, CA - 15,772 https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020 7

Physician Office Laboratories CLIA Laboratory Certification https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020 8

Number of CLIA Certificate of Accreditation Laboratories by Accreditation Organizations 6,091 6,409 7,000 6,000 5,000 4,000 3,000 1995 2,000 1,000 118 189 124 3 0 https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020 9

CLIA Exempt States Washington • HSQA/IIO- Laboratory Quality Assurance New York • 4,251 • Clinical Laboratory Evaluation Program • 5,518 https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020 10

Waived Tests Definition Simple laboratory examinations and procedures that are: • cleared by the Food and Drug Administration (FDA) for home use; or • employ methodologies that are so simple and accurate as to render likelihood of erroneous results negligible; or • pose no reasonable risk of harm to the patient if the test is performed incorrectly 11

Original Waived Tests: 1992 Urinalysis (non-automated) Fecal occult blood Ovulation tests (LH) (visual read) Urine pregnancy (visual read) ESR (non-automated) Hemoglobin (copper sulfate) Blood glucose (FDA approved for home use) Spun microhematocrit 12

# of Waived Analytes 80 70 60 50 40 30 20 10 0 1990 1995 2000 2005 2010 2015 2020 13

Current CLIA Waived Tests Nuclear Matrix Protein Fructosamine Adenovial Antigen RSV Glucose B. burgdorferi pH – Body fluids H. pyloris Bilirubin Pregnancy HgB/Hct Bladder Tumor Antigen Protein, Total HgB A1C BNP PT/INR HIV BUN/Creatinine RSV Group A Strep CBC Sperm Count Infectious Mono Cholesterol (Total, HDL)/Trigs T. vaginalis Influenza A/B Drugs of Abuse TSH Ketones Enzymes – Uric Acid • ALK, ALT, AMS, AST, CK, GGT Lead Urinary microalbumin/ Ethanol Lactate creatinine Fecal/Gastric Occult Blood MMP-9 Protein Urinalysis/Specific Gravity FSH/LH/Estrone 3 glucoronide Na, K, Ca ++ , Cl, CO 2 Vaginosis Fructosamine Nicotine X-linked N teleopeptides www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/Categorization_of_Tests.html, last accessed 7/20/20 14

CLIA Certified Laboratories 250 Certificate of Accreditation/Certificate of Compliance Provider Performed Microscopy Procedures Certificate 200 Certificate of Waiver Number of Labs (x1000) 150 100 50 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 Year https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020

Top Waived Tests 2003-04 n = 3,317 sites surveyed by CMS Howerton, et al. MMWR, Recommendations and Reports Nov 11, 2005 / 54(RR13);1-25

U.S. Point-of-Care Molecular Dx Market 2013-2024 1096 Forecast 89 38 472 140 www.grandviewresearch.com, last accessed 8/4/20 17

POCT Deficiencies 18

Common Survey Deficiencies in COW Laboratories Missing Current Manufacturer's Instructions Manufacturer's Instructions Not Followed Required Calib/Function Checks Not Performed Non-Licensure (n=162) Storage/Handling Instructions Not Followed State Licensure (n=108) Use Reagents Past Exp Date Manufacturer's QC Protocols Not Followed No Additional QC as Required Personnel Training Not Provided Personnel Competency Not Evaluated Testing beyond permit 0 10 20 30 40 50 Percentage of Labs With Deficiency Source: CMS Certificate of Waiver Procedures Pilot Project, 2002

Blood Glucose Used Adequate Specimen Collection/Labeling Techniques Followed Reagent Storage Recommendations Document Reagent Expiration Date & Lot Number Perform Recommended Calibration Perform Recommended QC Have Policy for Reacting to Failed QC Policy For Correcting Report Errors 0 20 40 60 80 100 Non-Affiliated (n=382) Affiliated (n=122) Percentage of Labs Source: CMS Certificate of Waiver Procedures Pilot Project, 2002

Affiliated Labs Used Adequate Specimen Collection/Labeling Techniques Followed Reagent Storage Recommendations Document Reagent Expiration Date & Lot Number Performed Recommended QC Adhere to Test Time Limitations Have Policy For Reacting to Failed QC Supervisor Actively Reviews QC Policy For Correcting Report Errors Strep Group A Antigen (n=62) Urine hCG (n=94) 0 20 40 60 80 100 Fecal Occult Blood (n=88) Percentage of Labs Urine Dipsticks (n=126) Source: CMS Certificate of Waiver Procedures Pilot Project, 2002

Non-Affiliated Labs Used Adequate Specimen Collection/Labeling Techniques Followed Reagent Storage Recommendations Document Reagent Expiration Date & Lot Number Performed Recommended QC Adhere to Test Time Limitations Have Policy For Reacting to Failed QC Supervisor Actively Reviews QC Policy For Correcting Report Errors Strep Group A Antigen (n=76) Urine hCG (n=146) 0 20 40 60 80 100 Fecal Occult Blood (n=205) Percentage of Labs Urine Dipsticks (n=253) Source: CMS Certificate of Waiver Procedures Pilot Project, 2002

% of Sites Not Conducting Selected Quality Assurance Practices QA Practice Affiliated Non-affiliated N=78 N=200 Training documentation 8 22 Assay validation 15 81 SOPM reviews by director 15 81 Staff competency checks 12 46 QC/QA review by director 9 37 Proficiency testing program 46 91

CMS, CAP, COLA & TJC Top Deficiencies 2016 Chittiprol S, Bornhorst, J,Kiechle, FL, Clinical Laboratory News; July 1, 2018 24

CLIA Top Ten Deficiencies, 2018 %All % Regulation Deficiency Labs POLs Cites Cited Criteria for reagent and specimen storage; test system operation; test 493.1252(b) 4.8 4.6 result reporting 493.1251(b) Complete procedure manual 4.6 4.5 At least 2X every year, verify accuracy of tests not enrolled in HHS 493.1236 (c)(1) 4.3 4.8 approved PT Policies/procedures followed to assess employee and, if applicable, 493.1235 4.1 4.1 consultant competency Policies/procedures followed to monitor, assess, and correct problems 489.1289(a) 4 3.8 identified in 493.1251-.1283 493.1291(c) Test report includes all mandated items 3.5 3.6 493.1251(a) Procedure manual for all tests followed by personnel 3.2 3.2 493.1252(d) Reagents, solutions, etc. used, not outdated or of substandard quality 3.1 3 493.1254(a)(1) Maintenance performed at least at manufacturer’s stated frequency 3.1 2.8 Each lab using unmodified FDA-approved tests must demonstrate 493.1253(b)(1) 2.8 2.2 attainment of manufacturers’ perf. specif. https://www.cms.gov/Regulations-and-Guidance/Legislation/ CLIA/CLIA_Statistical_Tables_Graphs.html Accessed 07/14/2020 25

Top Deficiencies 2019 Deficiency CAP COLA Testing Personnel Competency 1 1 (18%) Activity Menu 2 Instrument/Method Correlations 3 / 4* LD not fulfilling PT responsibilities 2 (16%) / 3* TC/TS not fulfilling responsibilities 3 (13%) / 6* LD not fulfilling QC/QA responsibilities 4 (12%) / 2* PT Review documentation 5 (12%) / 4* * - ranking in 2016 Make Your Lab Assessment Ready in 2020. Dark Daily. 2/25/20 Webinar. 26

Top Three Deficiencies for CLIA-waived Labs Not performing QC as required by the manufacturer Not having a current package insert Not complying with storage expiration dates Snyder, MT (ASCP), A. (Speaker) (2015, April 8). CLIA and Point-of-Care Testing. AACC POC Virtual Conference. 27