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CLSI POCT7 A : 1ED 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

QUALITY MANAGEMENT: APPROACHES TO REDUCING ERRORS AT THE POINT OF CARE

Superseded date

03-31-2023

Published date

08-25-2018

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Management and Safety Aspects of Point-of Care Testing
6 Source of Errors in Point-of -Care Testing
7 Using Quality Indicators to Improve Patient Safety
  Reduce Errors)
References
Additional References
Appendix A - Sample of a Simple Generic Nonconforming
             Event Report
Appendix B - Example of Documentation of Point-of-care
             Testing Occurrences
Appendix C - Presentation of Data
Summary of Delegate Comments and Responses
The Quality Management System Approach
Related CLSI Reference Materials

Provides the core infrastructure for a standardized error tracking system with the primary goals of reducing risk and increasing quality of point-of-care testing, while accumulating standardized data for benchmarking use.

This document provides a basic framework or infrastructure for a standardized risk management system.Error indicators for each analytical phase are suggested for incorporation into a quality managementprogram. This guideline serves as a complementary tool to laboratory quality management procedures.This guideline is intended for use by laboratory directors, managers, supervisors, quality managers, pointof-care coordinators (POCCs), and other testing personnel responsible for implementing the policies,processes, procedures, activities, and records that support the quality management activities describedherein. Although it is understood that point-of-care testing (POCT) is performed in a variety of settings,the structure and contents of this document focus more on hospital-based programs. The information in this document can be applied to all POCT instruments and kits. However, some parameters may be relevant only to POCT in hospital or large institutional settings.The goal of this guideline is to improve the performance of POCT by developing different indicators that are applicable to all aspects of preexamination, examination, and postexamination phases of the testing.This document highlights the critical components of a POCT quality management program, as well as defines the critical role that central laboratories should play in the coordination of POCT quality activities.

DevelopmentNote
Supersedes NCCLS POCT7 P. (05/2011)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI GP36-A : 2014 PLANNING FOR LABORATORY OPERATIONS DURING A DISASTER
I.S. EN ISO 22870:2016 POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 22870:2016)
BS EN ISO 22870:2016 Point-of-care testing (POCT). Requirements for quality and competence
EN ISO 22870:2016 Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
ISO 22870:2016 Point-of-care testing (POCT) — Requirements for quality and competence

CLSI POCT9 A : 1ED 2010 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
CLSI GP17 A2 : 2ED 2004 CLINICAL LABORATORY SAFETY
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI HS1 A2 : 2ED 2004 A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
CLSI QMS11 A : 1ED 2007 MANAGEMENT OF NONCONFORMING LABORATORY EVENTS
CLSI GP22 A2 : 2ED 2004 CONTINUOUS QUALITY IMPROVEMENT: INTEGRATING FIVE KEY QUALITY SYSTEM COMPONENTS
CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES

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