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PD ISO/TS 20658:2017

Current
Current

The latest, up-to-date edition.

Medical laboratories. Requirements for collection, transport, receipt, and handling of samples
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

11-09-2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management
5 Pre-examination processes relating to patient samples
6 Infrastructure and environmental conditions
7 Equipment and supplies
8 Infection prevention and control (biosafety)
9 Personnel
10 Information for patients and users of services
11 Request form
12 Patient identification
13 Identification of samples
14 Sample collection
15 Sample integrity and stability
16 Transport of samples
17 Sample receipt and assessment
18 Sample storage prior to examination
19 Customer satisfaction
20 Identification and control of nonconformities
21 Performance indicators
22 Documents and records
Annex A (informative) - Your five moments for
        hand hygiene
Annex B (informative) - Disinfectants
Bibliography

Describes requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations.

This document specifies requirements and good practice recommendations for the collection, transport, receipt and handling of samples intended for medical laboratory examinations.

This document is applicable to medical laboratories and other medical services involved in laboratory pre-examination processes that include the examination request, patient preparation and identification, sample collection, transport, receipt and storage. It may also be applicable to some biobanks.

This document does not apply to blood and blood products intended for transfusion.

Committee
CH/212
DocumentType
Standard
Pages
46
PublisherName
British Standards Institution
Status
Current

Standards Relationship
ISO/TS 20658:2017 Identical

ISO 15189:2012 Medical laboratories — Requirements for quality and competence
CLSI GP33 A : 1ED 2010 ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION
CLSI GP44 A4 : 4ED 2010 PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS
ISO 15190:2003 Medical laboratories Requirements for safety
CLSI GP41 A6 : 6ED 2007 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
CLSI MM20 A : 1ED 2012 QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING
ISO 9001:2015 Quality management systems — Requirements
CLSI MM13 A : 1ED 2006 COLLECTION, TRANSPORT, PREPARATION, AND STORAGE OF SPECIMENS FOR MOLECULAR METHODS
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS

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