Standard Document
First Edition
Point-of-Care Testing

CLSI POCT16

Emergency and Disaster Point-of-Care Testing

CLSI POCT16 provides guidance on the use of point-of-care testing devices in emergency and disaster settings.

May 21, 2025
Gerald J. Kost, MD, PhD, MS, FACB; James H. Nichols, PhD, DABCC, FACB

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Abstract

Clinical and Laboratory Standards Institute POCT16—Emergency and Disaster Point-of-Care Testing provides guidance on the use of point-of-care testing (POCT) devices in emergency and disaster settings. CLSI POCT16 serves as a resource by providing a framework for POCT use in emergencies and disasters, recommendations for selecting appropriate devices, and criteria to assess device performance. The recommendations described in CLSI POCT16 will increase user confidence and benefit patients by improving the reliability of test results. Additionally, government agencies can use CLSI POCT16 as a resource to equip emergency and disaster response teams with POCT devices and the knowledge needed to operate them properly.

Scope

CLSI POCT16 provides recommendations for improving performance and quality of point-of-care testing (POCT) used in complex emergency and disaster settings. It provides criteria for POCT use in emergencies and disasters and a framework for POCT device performance assessment. In CLSI POCT16, POCT refers to devices with measurement capabilities beyond blood glucose. CLSI POCT16 is useful to the following groups and is appropriate for broad global application: 

• Point-of-care coordinators (POCCs), laboratory directors, and hospital administrators 

• Laboratorians, disaster responders, emergency care personnel, and other groups who respond to adverse medical crises worldwide 

• Point-of-care (POC) device manufacturers, as a source of performance expectations for their devices and test kits 

• Government agencies, nongovernmental organizations, and other organizations 

CLSI POCT16 does not discuss the use of POCT devices in planning for hospital laboratory downtimes, electrical outages, or other situations covered in CLSI GP36.1 CLSI POCT16 is not intended to be all encompassing or to preempt other disaster plans. Rather, this guideline is intended to complement existing local, regional, and national disaster management strategies. Testing for chemical and bioterrorism is not described.

Product Details
POCT16Ed1E
978-1-68440-277-9
140
Authors
Gerald J. Kost, MD, PhD, MS, FACB
James H. Nichols, PhD, DABCC, FADLM
Cynthia Foss Bowman, MD
Sarah M. Brown, PhD
Natalie Campbell, RT
Mick Cote, MS, CEM
Corbin Curtis, BS
Claudia Derse-Anthony, RN
Sharon S. Ehrmeyer, PhD, MLS(ASCP)
William Ferguson
Mary J. Gilchrist, PhD, D(ABMM)
Audrey Gillette, BS, ASCP, MBA
Kerstin A. Halverson, MS
Daniel Hesselgesser, MLS(ASCP)
Roberta E. Hirsch Rosemary Humes, MS, MLS(ASCP)SM
T. Scott Isbel, PhD, DABCC, FACB
Kyu-Tae Lee, BS
Richard Louie, PhD
Peggy Mann, MS, MLS(ASCP)
Ann Sakaguchi, PhD, MPH
Mark Shephard, PhD, MAACB, OAM
Roxanne G. Shively, MS
Eleanor M. Travers, MD, MHA, FCAP
Richard Y. Wang, DO, FACEP, FACMT
Thomas Williams, MD, FACB, FASCP, FCA
Lou Ann Wyer, MS, MLS(ASCP), ASQ, CQA
Abstract

Clinical and Laboratory Standards Institute POCT16—Emergency and Disaster Point-of-Care Testing provides guidance on the use of point-of-care testing (POCT) devices in emergency and disaster settings. CLSI POCT16 serves as a resource by providing a framework for POCT use in emergencies and disasters, recommendations for selecting appropriate devices, and criteria to assess device performance. The recommendations described in CLSI POCT16 will increase user confidence and benefit patients by improving the reliability of test results. Additionally, government agencies can use CLSI POCT16 as a resource to equip emergency and disaster response teams with POCT devices and the knowledge needed to operate them properly.

Scope

CLSI POCT16 provides recommendations for improving performance and quality of point-of-care testing (POCT) used in complex emergency and disaster settings. It provides criteria for POCT use in emergencies and disasters and a framework for POCT device performance assessment. In CLSI POCT16, POCT refers to devices with measurement capabilities beyond blood glucose. CLSI POCT16 is useful to the following groups and is appropriate for broad global application: 

• Point-of-care coordinators (POCCs), laboratory directors, and hospital administrators 

• Laboratorians, disaster responders, emergency care personnel, and other groups who respond to adverse medical crises worldwide 

• Point-of-care (POC) device manufacturers, as a source of performance expectations for their devices and test kits 

• Government agencies, nongovernmental organizations, and other organizations 

CLSI POCT16 does not discuss the use of POCT devices in planning for hospital laboratory downtimes, electrical outages, or other situations covered in CLSI GP36.1 CLSI POCT16 is not intended to be all encompassing or to preempt other disaster plans. Rather, this guideline is intended to complement existing local, regional, and national disaster management strategies. Testing for chemical and bioterrorism is not described.

POCT16Ed1E
978-1-68440-277-9
140
Authors
Gerald J. Kost, MD, PhD, MS, FACB
James H. Nichols, PhD, DABCC, FADLM
Cynthia Foss Bowman, MD
Sarah M. Brown, PhD
Natalie Campbell, RT
Mick Cote, MS, CEM
Corbin Curtis, BS
Claudia Derse-Anthony, RN
Sharon S. Ehrmeyer, PhD, MLS(ASCP)
William Ferguson
Mary J. Gilchrist, PhD, D(ABMM)
Audrey Gillette, BS, ASCP, MBA
Kerstin A. Halverson, MS
Daniel Hesselgesser, MLS(ASCP)
Roberta E. Hirsch Rosemary Humes, MS, MLS(ASCP)SM
T. Scott Isbel, PhD, DABCC, FACB
Kyu-Tae Lee, BS
Richard Louie, PhD
Peggy Mann, MS, MLS(ASCP)
Ann Sakaguchi, PhD, MPH
Mark Shephard, PhD, MAACB, OAM
Roxanne G. Shively, MS
Eleanor M. Travers, MD, MHA, FCAP
Richard Y. Wang, DO, FACEP, FACMT
Thomas Williams, MD, FACB, FASCP, FCA
Lou Ann Wyer, MS, MLS(ASCP), ASQ, CQA