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Clinical and Laboratory Standards Institute David Sterry, MT(ASCP) Director, Standards, CLSI KEYPOCC Meeting Kennett Square, PA June 15, 2012

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Page 1: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Clinical and Laboratory Standards Institute

David Sterry, MT(ASCP)Director, Standards, CLSI

KEYPOCC MeetingKennett Square, PA

June 15, 2012

Page 2: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Our Common Goal: Quality Health Care

Page 3: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Today’s Presentation• CLSI background information• Membership and volunteers• Document development process• Crosswalks with the College of American Pathologists

(CAP) and The Joint Commission• Quality management systems• Point-of-care testing (POCT) documents and companion

products• POCT10-A2—Physician and Nonphysician Provider-

Performed Microscopy Testing; Approved Guideline—Second Edition

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Page 4: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Background

• Established in 1968• Nonprofit corporation based in the United

States• Accredited standards-developing

organization• An organization of organizations

–(no individual memberships)

Page 5: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Organizational Chart

.CLSI Member Organizations

Board of Directors

Executive Committee

Chairholders Council

Consensus Committees

Document Development Committees

Working Groups

Subcommittees

CLSI staff (45 employees)

2300 activevolunteers

2000 member organizations;no individual memberships

70 activeprojectsat a time

ANSI*accredited

75 000documents

distributed peryear

*American National Standards Institute

Page 6: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Recognized Worldwide

distributed to 90 countries

Page 7: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Vision

To be the leader in clinical and laboratory standards to improve the quality of medical care.

Page 8: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Mission

To develop best practices in clinical and laboratory testing and promote their use throughout the world,

using a consensus-driven process that balances the viewpoints of industry, government, and the

health care professions.

Page 9: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Consensus Process

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Professions

Balance

Industry

Government

Page 10: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Consensus Process

• Meetings are open to everyone.

• Meeting materials are available to participants and interested parties.

• A balance of interests is maintained.

• Conflicts of interest are fully disclosed.

• An appeals process exists to address issues or concerns.

Page 11: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Standardization in the Medical Laboratory

the right laboratory test at the right time with the right result leads to quality diagnostics,improved patient care, andimproved public healtharound the world

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Standardized test

Standardized procedure

Standardized reporting

Improved outcomes

Page 12: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Products

• Standards• Guidelines• Reports• Companion Products

–Quick Guides–Toolkits–Specialty Collections–DVDs–Software

Page 13: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Standards and the Laboratory

• Most medical laboratory errors are caused by systems and process issues, not people.

• These are the areas where standards can help the most.

Page 14: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Standards Development Consensus

A consensus standard or guideline is a document developed to promote uniform products, materials, methods, or practices.

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Page 15: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Membership and Volunteers

Over 600 non–North American members and volunteers from over 70 countries, and

growing

Page 16: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Members and Volunteers

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Diverse representation from three constituencies

Industry Government ProfessionsIn vitro diagnostics manufacturers

Public health agencies Hospitals and laboratories

Laboratory information systems vendors

Regulatory bodies Health care delivery systems

Startup companies Accrediting organizations Educational institutionsSuppliers Professional societiesTrade organizations

Page 17: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Members and Volunteers

– Argentina– Australia– Belgium– Brazil– Bulgaria– Canada– France– Germany– Hong Kong– India

– Iran– Israel– Italy– Japan– Korea– Mexico– Netherlands– PR China

Russia

– Saudi Arabia– South Africa– Spain– Sweden– Taiwan– Trinidad/Tobago– Turkey– United Kingdom– United States

Page 18: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Consensus Committees

• Automation and Informatics

• Clinical Chemistry and Toxicology

• Evaluation Protocols

• Hematology

• Immunology and Ligand Assay

• Microbiology• Molecular Methods• Point-of-Care Testing• Quality Systems and

Laboratory Practices

Page 19: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Committee Structure

• Chairholder

• Vice-Chairholder

• Members

• Advisors

• Contributors

• Reviewers

• Project Manager/Staff Liaison (Executive Offices’ staff)

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Page 20: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

The Document Development Process

Project Idea → Published Document

Page 21: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Idea → Document Project

• Identified need/project idea• Project proposal developed• Assessment/endorsement by

consensus committee• Call for volunteers• Document development committee (DDC)

membership established• Business plan developed• Presentation to Chairholders Council • Project authorization

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Page 22: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Document Development Process

• The document development process begins with the inaugural webinar for the DDC.

• Refine expanded outline.

• Introduce draft text to support scope and outline points.

• Prepare text for submission as a preliminary draft document.

Page 23: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Five Voting Stages

• Voting Stage 1: Draft 1 for document development committee approval

• Voting Stage 2: Draft 2 for approval by delegates; review and comment by consensus committee, board of directors, and nonmembers– Replaces proposed-level documents, which are

no longer published– Provided to member organizations at no cost

Page 24: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Five Voting Stages (cont’d)

• Voting Stage 3: Draft 3 for document development committee approval

• Voting Stage 4: Draft 4 for review and approval by consensus committee

• Voting Stage 5: Final Draft for consensus committee approval to publish

Page 25: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Two Timeline Tracks

Track 1 – 15-month timelineTrack 2 – 25-month timeline

Timeline determined by:• Scope• Complexity• Comprehensiveness and depth• Degree of controversy

Page 26: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Publications – Approved Level

Automation 21Clinical Chemistry 24Evaluation Protocols 17Hematology 29Immunology 26Microbiology 42Point-of-Care Testing 8Quality Systems 38Molecular Methods 16

Total 221

Page 27: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Document Review Schedule

Within five years after its approval, the appropriate consensus committee(s) initiates a review to determine the necessary action to reaffirm, revise, archive, or withdraw an approved consensus document.

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Page 28: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Crosswalks with CAP and The Joint Commission

Page 29: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Adoption of Documents Into Accreditation Crosswalk

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Page 30: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI Documents Referenced to The Joint Commission

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Page 31: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Quality Management Systems

Page 32: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Quality Management System

The Quality Management System (QMS)provides a framework for managing and

monitoring activities to address quality standards

and achieve organizational goals.

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Page 33: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Quality Systems and the Laboratory

Principles of high-quality laboratory testing are the same anywhere in the world.

It is one area of health carethat can be, and should be,highly standardized.

Page 34: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

CLSI and the Quality Management System

CLSI produces globally recognized QMS guidelines.

• GP26-A4—Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition

• “The Key to Quality”

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Page 35: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Quality Systems Models

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There are two major models for QMS used globally.

ISO: 15189 CLSI: GP26-A4• Broad-based• Overarching standards• 15 management requirements• Eight technical requirements

• Specific• Practical implementation

guidelines• 12 quality systems essentials

Both are built on the same concepts, but differ in the amount of specificity described.

ISO is broader and CLSI is more specific.ISO = what to do; CLSI = how to do it

Page 36: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Quality Management System

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QMS is a simple, systematic approach of organizing all key work processes around the path of workflow in the laboratory.

GP26-A4—Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition

Page 37: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Global Momentum Toward QMS Adoption

40+ countries have implemented, or are in some stages of national adoption, of the QMS model approach to their laboratory services.

The World Health Organization has fully adopted the QMS approach on a global basis and is in the process of education and training.

In the United States, the Centers for Medicare & Medicaid Services is encouraging laboratories to adopt a QMS approach to laboratory licensure and accreditation.

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Page 38: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

POCT Documents and Companion Products

Page 39: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Why is Point-of-Care Testing Important?

• Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing.

• Estimated revenues of approximately $3 billion (USD), excluding non-IVD applications and whole blood glucose testing

• Overall IVD market growth 6 to 7% per year• POCT market growth 10 to12% per year• Numerous new technologies and applications entering

POCT (eg, molecular methods, MRSA)

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IVD Market R. Sutherland, Jan 2010

Page 40: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Point-of-Care Testing Guidelines

• AST04-A2—Glucose Monitoring in Settings Without Laboratory Support; Approved Guideline—Second Edition (under revision; will be published as POCT13)

• C30-A2—Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Second Edition (under revision; will be published as POCT12)

• H49-A—Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline

• POCT01-A2—Point-of-Care Connectivity; Approved Standard—Second Edition

• POCT02-A—Implementation Guide of POCT01 for Health Care Providers; Approved Guideline

• POCT04-A2—Point-of-Care In Vitro Diagnostic Testing; Approved Guideline—Second Edition (under revision)

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Page 41: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Point-of-Care Testing Guidelines

• POCT05-A—Performance Metrics for Continuous Interstitial Glucose Monitoring; Approved Guideline

• POCT07-A—Quality Management: Approaches to Reducing Errors at the Point of Care; Approved Guideline

• POCT08-A—Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers; Approved Guideline

• POCT09-A—Selection Criteria for Point-of-Care Testing Devices; Approved Guideline

• POCT10-A2—Physician and Nonphysician Provider-Performed Microscopy Testing; Approved Guideline—Second Edition

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Page 42: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Guidelines in Development

• POCT06—Guidelines on the Impact on Glucose Measurement When Different Sample Types Are Used

• POCT14—Point-of-Care Testing for Infectious Disease

• POCT15—Emergency and Disaster Point-of-Care Testing

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Page 43: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Potential Projects

• Noninvasive monitoring

• Oral POCT

• Cost and advantages of POCT vs testing in main laboratory (a report)

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Page 44: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Companion Products for POCT Documents

• POCT07—Addressing errors in point-of-care testing (reference guide)

• POCT08—Quality control troubleshooting (flow chart)

• POCT08—Corrective action report (quick guide)• POCT08—Quality control log sheet (quick guide)• POCT09—Instrument selection (worksheet)

Clinical needs assessment Testing system specifications

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Page 45: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

POCT07 Companion Product

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Page 46: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

POCT08 Companion Product

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Page 47: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

POCT10-A2, Physician and Nonphysician Provider-Performed

Microscopy Testing; Approved Guideline—Second Edition

Page 48: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

General Information

• Safety – personal protective equipment, hand hygiene, workspace disinfection, medical waste, and chemical safety

• Microscope – operation and maintenance• Quality assurance – training and competency of

the provider, procedure manual, QC, proficiency testing, and accreditation

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Page 49: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Procedures Included in POCT10-A2

• Fecal leukocyte examination• Fern test• Nasal smears for inflammatory cells• Pinworm examinations• Postcoital, direct, qualitative examinations of

cervical mucus• Qualitative semen analysis• Urine sediment examination• Wet mount preparations and potassium hydroxide

(KOH) preparations

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Page 50: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Consistent Layout of Procedures

• Principle• Materials• Specimen collection• Testing procedure• Quality control• Reporting results• Limitations of the procedure

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Page 51: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Appendixes in POCT10-A2

• Microscopic components of urine sediment• Microscopic components in vaginal fluid and KOH

preparations• Ectoparasites• List of figures and tables

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Page 52: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Updates to POCT10-A2

• A reorganized and more comprehensive section (Section 14) for wet preparations, identifying differences between wet preparation for vaginal and nonvaginal procedures

• Representative pictures (or images) for as many procedures as possible, to facilitate training programs using this document as a teaching tool

• To complement the inclusion of so many images, the creation of Appendix C to help the reader identify and locate the images within the document

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Page 53: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

POCT10-A2 Companion Products

Page 54: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Checklists

• Cumulative training • Employee training

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Page 55: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Forms

• Proficiency testing exception response form

• Microscope maintenance log

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Page 56: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Wall Charts

• Microscopic components in urine sediment• Microscopic components in vaginal fluid and KOH

preparations• Ectoparasites

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Page 57: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Procedures

• Fecal leukocyte examination• Nasal smears for inflammatory cells• Urine sediment examinations• Wet mount and KOH preparations

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Page 58: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Summary

• CLSI is an internationally recognized, consensus-based standards organization that produces a large number of documents and related materials.

• Document development is a highly organized, systematic process involving a balanced approach by all stakeholders.

• QMS improve laboratory practice.• Documents are applicable in laboratory standardization,

preparation for inspection and accreditation, and in improving the quality of results and patient care.

• POCT documents can provide guidance as well as tools to help create and maintain a comprehensive program.

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Page 59: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

How to Contact CLSI

• Web: www.CLSI.org

• E-mail: [email protected]

• Customer Service: 1.610.688.0100

• David Sterry• [email protected]• Phone: 484.588.5942

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Page 60: Clinical and Laboratory Standards Institute · • Point-of-care testing (POCT) includes patient self testing, physician office laboratories, and hospital-based testing. • Estimated

Thank you.

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