Standard Document
First Edition
Point-of-Care Testing

CLSI POCT02

Implementation Guide of POCT01 for Health Care Providers

This document identifies and describes the specific features that a POCT01-compliant device should ideally have, dividing them into obligatory and desirable categories. The guideline provides healthcare providers and end users with a practical basis for creating a list of features or questions to be addressed by the vendor of a compliant device.

This document is exclusively available in an electronic format for your convenience and accessibility.

May 27, 2008
Patrick J. St. Louis, PhD, DipCC

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Abstract

Clinical and Laboratory Standards Institute document POCT02-A—Implementation Guide of POCT01 for Health Care Providers; Approved Guideline identifies and describes the particular features that a POCT01-compliant device should ideally have. These features are divided into obligatory and desirable categories. Key terms are identified and the most frequent use cases are presented. The guideline thus gives the health care provider or end user a practical basis for establishing a list of features or questions to be addressed by the vendor of a compliant device. Where appropriate, it also indicates options that may be applicable. The guideline, at the same time, tries to be flexible in allowing for adaptation to specific cases and also in considering probable technological advances in the evolution of connectivity solutions. The use of this guideline should thus permit health care providers to acquire the device with a connectivity solution best suited to their needs and also to encourage the development of an acceptable industry-wide standard.

Scope
This guideline provides the health care provider or end user with clear, concise information on what features to expect in a connectivity-compliant device and practical advice on how to optimally apply these features to their daily operation/practice. It also addresses possible pitfalls, including the question of security, identified by the committee and its advisors. Where necessary or useful, it defines and explains, in nontechnical language, terms used in the POCT01 standard. This guideline does not address manufacturers’ requirements. It is intended that health care providers, by taking into account the information in this document, will be able to develop a list of questions, specific to the particular test and their site, which need to be addressed by potential vendors. This list of questions would be based on the features that a compliant device should have, which are described in this document. Given continuous changes in the area of point-of-care testing (POCT), as well as continuing technological advances, health care providers are encouraged to ask questions or request modifications that reflect these advances. Some sections in this document provide an overview of desirable features in a compliant device and an example set of questions that may be put to potential vendors.
Product Details
POCT02AE
1-56238-670-0
52
Additional Details

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Patrick J. St. Louis, PhD, DipCC
Mark Maund
Marcy Anderson, MS, MT(ASCP)
Walter Nedetzky, PhD
David Colard, MT(ASCP)
James H. Nichols, PhD, DABCC, FACB
Diana R. DeHoyos, MS
Edward J. Peterson, Jr., MBA, MT(ASCP)
Jake Geller, PhD
Andrew St. John, PhD
Martin H. Kroll, MD
Abstract

Clinical and Laboratory Standards Institute document POCT02-A—Implementation Guide of POCT01 for Health Care Providers; Approved Guideline identifies and describes the particular features that a POCT01-compliant device should ideally have. These features are divided into obligatory and desirable categories. Key terms are identified and the most frequent use cases are presented. The guideline thus gives the health care provider or end user a practical basis for establishing a list of features or questions to be addressed by the vendor of a compliant device. Where appropriate, it also indicates options that may be applicable. The guideline, at the same time, tries to be flexible in allowing for adaptation to specific cases and also in considering probable technological advances in the evolution of connectivity solutions. The use of this guideline should thus permit health care providers to acquire the device with a connectivity solution best suited to their needs and also to encourage the development of an acceptable industry-wide standard.

Scope
This guideline provides the health care provider or end user with clear, concise information on what features to expect in a connectivity-compliant device and practical advice on how to optimally apply these features to their daily operation/practice. It also addresses possible pitfalls, including the question of security, identified by the committee and its advisors. Where necessary or useful, it defines and explains, in nontechnical language, terms used in the POCT01 standard. This guideline does not address manufacturers’ requirements. It is intended that health care providers, by taking into account the information in this document, will be able to develop a list of questions, specific to the particular test and their site, which need to be addressed by potential vendors. This list of questions would be based on the features that a compliant device should have, which are described in this document. Given continuous changes in the area of point-of-care testing (POCT), as well as continuing technological advances, health care providers are encouraged to ask questions or request modifications that reflect these advances. Some sections in this document provide an overview of desirable features in a compliant device and an example set of questions that may be put to potential vendors.
Additional Details

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

Authors
Patrick J. St. Louis, PhD, DipCC
Mark Maund
Marcy Anderson, MS, MT(ASCP)
Walter Nedetzky, PhD
David Colard, MT(ASCP)
James H. Nichols, PhD, DABCC, FACB
Diana R. DeHoyos, MS
Edward J. Peterson, Jr., MBA, MT(ASCP)
Jake Geller, PhD
Andrew St. John, PhD
Martin H. Kroll, MD