CLIA and Point of Care Testing Serafina Brea, MBEE, MLS(ASCP) CM - - PowerPoint PPT Presentation

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CLIA and Point of Care Testing Serafina Brea, MBEE, MLS(ASCP) CM - - PowerPoint PPT Presentation

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CLIA and Point of Care Testing Serafina Brea, MBEE, MLS(ASCP) CM Clinical Laboratory Scientist Centers for Medicare & Medicaid Services Center for Clinical Standards & Quality Quality, Safety & Oversight Group Division of Clinical

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Serafina Brea, MBEE, MLS(ASCP)CM

Clinical Laboratory Scientist Centers for Medicare & Medicaid Services Center for Clinical Standards & Quality Quality, Safety & Oversight Group Division of Clinical Laboratory Improvement & Quality

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CLIA and Point of Care Testing

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This presentation was prepared as a service to the public and is not intended to grant rights or impose

  • bligations. This presentation may contain

references or links to statutes, regulations, or other policy materials. The information provided is only intended to be a general summary. It is not intended to take the place of either the written law or

  • regulations. We encourage readers to review the

specific statutes, regulations, and other interpretive materials for a full and accurate statement of their contents.

Disclaimer

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  • General overview of CLIA
  • Guidance on regulations regarding point of

care testing

  • CLIA updates

Objectives

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  • Clinical Laboratory Improvement

Amendments

  • Minimum federal standards laboratories must

follow

What is CLIA?

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  • Public Law 100-578 CLIA ’88 signed by

President on October 31, 1988

  • CLIA final rules 42 CFR part 493

(administrative processes and quality standards) published on February 28, 1992

  • CLIA final rules effective on September 1,

1992

  • Uniform standards to ensure accuracy,

reliability and timeliness

CLIA History

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CMS

Clinical Laboratory Oversight

FDA

Test Categorization

CDC

Scientific Consultation

DHHS

CLIA Program Responsibilities

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A facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

Laboratory (as defined by CLIA)

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That perform testing on patient specimens must:

  • Apply for a CLIA certificate;
  • Pay appropriate fees; and
  • Follow applicable CLIA requirements

All Clinical Laboratories…

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High Moderate (including PPM) Waived

Test Complexity

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  • Certificate of Compliance (CoC)
  • Certificate of Accreditation (CoA)
  • Certificate for Provider-performed Microscopy

(PPM) Procedures

  • Certificate of Waiver (CoW)

CLIA Certificate Types

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CoC 7% CoA 6% CoW 75% PPM 12%

CERTIFICATE TYPES

Source: CMS CLIA Database, April 2019

Current Enrollment Statistics

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  • CLIA (State Agencies/Regional Office)
  • Accreditation Organizations (AO)

Continuous Laboratory Oversight

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  • Surveyed for compliance with the CLIA

regulations

  • Can perform waived, moderate and high

complexity testing

  • Pay biennial certificate fees
  • Routinely surveyed every two years by State

Agencies

Certificate of Compliance

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  • Laboratory selects Accrediting Organization at

time of CLIA application

  • Can perform waived, moderate and high

complexity testing

  • Pay biennial certificate fees
  • Routinely surveyed every two years by AO

survey team

Certificate of Accreditation

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  • AABB
  • American Association for Laboratory Accreditation

(A2LA)

  • Accreditation Association for Hospitals and Health

Systems/ Healthcare Facilities Accreditation Program (AAHHS/HFAP)

  • American Society for Histocompatibility and

Immunogenetics (ASHI)

  • COLA
  • College of American Pathologists (CAP)
  • The Joint Commission

CMS Approved AOs

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  • Pay biennial certificate fees
  • Not subject to routine surveys
  • Can perform PPM procedures and waived

testing

  • Examples of PPM include:

– KOH preparations – Fern tests – Urine sediment examinations Certificate for Provider-performed Microscopy (PPM) Procedures

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Which test is not a PPM procedure?

  • A. Semen analysis; presence and/or motility
  • B. Nasal smears for eosinophils
  • C. Tzanck smear
  • D. Fecal leukocyte examination

Knowledge Check

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  • Enroll in the CLIA program
  • Pay biennial certificate fees
  • Only perform tests categorized as waived
  • Not subject to routine surveys
  • Must follow manufacturer’s instructions

Certificate of Waiver

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Subpart of 493 – Laboratory Requirements Waived Nonwaived Subpart A – General Provisions ✓ ✓ Subpart B – Certificate of Waiver ✓ Subpart C – Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance ✓ Subpart D – Certificate of Accreditation ✓ Subpart E – Accreditation by a Private, Nonprofit Accreditation Organization

  • f Exemption Under an Approved State Laboratory Program

✓ Subpart F – General Administration ✓ ✓ Subpart H – Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing ✓ Subpart I – Proficiency Testing Programs for Nonwaived Testing ✓ Subpart J – Facility Administration for Nonwaived Testing ✓ Subpart K – Quality System for Nonwaived Testing ✓ Subpart M – Personnel for Nonwaived Testing ✓ Subpart Q – Inspection ✓ ✓ Subpart R – Enforcement Procedures ✓ ✓

Waived vs Nonwaived

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  • Waived
  • Moderate complexity
  • PPM procedures
  • High complexity

Nonwaived

Point of Care Testing

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Waived:

  • Follow manufacturer’s instructions

Nonwaived:

  • §493.1256(d) Unless CMS approves a procedure, specified

in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must:

– Follow additional specialty and subspecialty requirements – Perform control procedures using the number and frequency specified by the manufacturer or established by the lab when they meet or exceed performing two levels of QC each day of patient testing [§493.1256(d)(2)]

Quality Control

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Waived:

  • Not applicable

Nonwaived:

  • If manufacturer’s instructions are less stringent

than CLIA regulations, either follow CLIA control regulations at §493.1256-1278 or perform an IQCP

When Should You Consider an IQCP?

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  • Voluntary, tailored QC plan specific for your

testing environment

  • Entire testing process: preanalytic, analytic,

postanalytic

  • Includes:

– Risk Assessment (RA) – Quality Control Plan (QCP) – Quality Assessment (QA) – LD signature

IQCP…cont.

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  • Waived testing

– Laboratory Director (LD)

Personnel Requirements

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  • Moderate complexity testing

– Laboratory Director (LD) – Technical Consultant (TC) – Clinical Consultant (CC) – Testing Personnel (TP)

Personnel Requirements

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  • PPM procedures

– Laboratory Director (LD)

  • Physician (MD, DO, DPM), midlevel practitioner (nurse

midwife, nurse practitioner, physician assistant), dentist

– Testing Personnel (TP)

  • Physician (MD, DO, DPM), midlevel practitioner (nurse

midwife, nurse practitioner, physician assistant), dentist

Personnel Requirements

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  • High complexity testing

– Laboratory Director (LD) – Technical Supervisor (TS) – Clinical Consultant (CC) – General Supervisor (GS) – Testing Personnel (TP)

Personnel Requirements

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28 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Non-Exempt Laboratories by Application Type

CoW PPM CoC/CoA Source: CMS CLIA Database, April 2019

Laboratory Growth Nationwide

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  • CMS surveyed a percentage of CoW

laboratories nationwide

  • Announced surveys geared towards education
  • Surveyors determined:

– Patient safety – Regulatory compliance – Waived tests only

Certificate of Waiver (CoW) Project

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  • Failed to have current manufacturer’s

instructions

  • Failed to perform quality control per

manufacturer’s instructions

  • Failed to follow manufacturer’s instructions
  • Performed nonwaived testing

Findings from CoW Project

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  • Can lead to misdiagnosis
  • Confirms complaints from the public
  • Most important… PATIENT SAFETY

Why is this Important?

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  • Initiated test menu collection with CLIA

application

  • Created educational booklets in collaboration

with the CDC

  • Enlisted support of professional and patient

advocacy organizations

What Did We Do?

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Federal Register:

1/9/2018, Request for Information CMS-3326-NC: Revisions to Personnel Regulations, PT Referral, Histocompatibility Regs and Fee Regs. 2/4/2019, Proposed Rule CMS-3355-P: CLIA PT Regulations Related to Analytes and Acceptable Performance

CLIA Updates

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Name Hyperlink CMS CLIA website https://www.cms.gov/Regulations-and- Guidance/Legislation/CLIA/index.html?redirect =/CLIA/ MLN Fact Sheet https://www.cms.gov/Outreach-and- Education/Medicare-Learning-Network- MLN/MLNProducts/Downloads/CLIABrochure .pdf CDC CLIA website https://wwwn.cdc.gov/CLIA/Default.aspx FDA CLIA website https://www.fda.gov/medical-devices/ivd- regulatory-assistance/clinical-laboratory- improvement-amendments-clia FDA CLIA Database https://www.accessdata.fda.gov/scripts/cdrh/cfd

  • cs/cfCLIA/search.cfm

Resources

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  • LabExcellence@cms.hhs.gov
  • CLIA@fda.hhs.gov
  • DLSInquiries@cdc.gov

QUESTIONS?

Contacts