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Z316.7-12 (R2017)

Current
Current

The latest, up-to-date edition.

Primary sample collection facilities and medical laboratories - Patient safety and quality of care - Requirements for collecting, transporting, and storing samples
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2012

Preface
0 Introduction
1 Scope
2 Reference publications
3 Definitions
4 General
5 Quality management system
6 Patient safety and quality of care
7 Facility conditions
8 Equipment and supplies
9 Personnel
10 Infection prevention and control
11 Primary sample collection
12 Identification of samples
13 Sample integrity
14 Sample receipt, assessment, accessioning, stabilization,
   and storage
15 Transport of samples
Annexes
A (informative) - Quality management
B (informative) - Biochemistry samples
C (informative) - Hematology samples
D (informative) - Coagulation samples
E (informative) - Transfusion medicine samples
F (informative) - Pathology samples
G (informative) - Cytology samples
H (informative) - Immunohistochemistry samples
I (informative) - Microbiology samples
J (informative) - Molecular diagnostics samples
K (informative) - Additional publications

Overview CSA Z316.7-12 - Primary Sample Collection Facilities and Medical Laboratories – Patient Safety and Quality of Care Requirements for Collecting, Transporting, and Storing Samples CSA Z316.7-12 - Medical laboratories and sample collection facilities, and in particular the effective management of pre-examination processes and activities, are important to the delivery of quality patient care. They contribute to the physical safety of the patient and provide information for critical medical decisions. The term “pre-examination activities” refers to the step-by-step processes that start with the sample request and move through patient preparation, sample collection, transport, stabilization, and end when sample examination activities begin. This is the first edition of Z316.7, and it was developed in part drawing from such documents as: Ordre professionnel des technologistes médicaux du Québec (OPTMQ) Rules of Practice, ISO 15189:2007 - Medical Laboratories — Particular Requirements for Quality and Competence , Clinical Laboratory and Standards Institute (CLSI) Standards and Guidelines, and Health Canada Infection Control Guidelines. The standard can be used standalone or applied in conjunction with ISO15189, and can be adopted by accreditation bodies and health ministries. Highlights of Z316.7 Include: Reinforcement of the importance of pre-examination processes Focus on overall patient safety and quality of care as well as patient communication, ethics, privacy Personnel training requirements and competency assessment Infection prevention and control including patient waiting areas, hand hygiene, and collection precautions Specifications for particular elements to consider when performing primary sample collection procedures Informative annexes that provide additional information on collection, handling and stabilization if samples for biochemistry, microbiology and molecular studies CSA Z316.7:12 Tool kit is available as a FREE DOWNLOAD!

Preface This is the first edition of CSA Z316.7, Primary sample collection facilities and medical laboratories - Patient safety and quality of care - Requirements for collecting, transporting, and storing samples. Scope 1.1 This Standard establishes quality requirements for sample collection, transport, and storage to ensure that patient safety and quality of care are at the forefront of the pre-examination process of laboratory testing. 1.2 Specific procedures for each step of the pre-examination process of laboratory testing are beyond the scope of this Standard and should be performed in accordance with recognized standards. 1.3 Although the requirements of this Standard also apply to point-of-care sample collection, point-of-care testing itself is beyond the scope of this Standard. CAN/CSA-Z22870 specifies requirements for such testing. 1.4 In this Standard, \"shall\" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; \"should\" is used to express a recommendation or that which is advised but not required; and \"may\" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.

DevelopmentNote
French Edition issued on 01/03/2013. (04/2013) GEN INS 1 14 only available in French Version. (07/2014)
DocumentType
Standard
ISBN
978-1-55491-851-5
Pages
68
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Current
Supersedes

ISO 15189:2012 Medical laboratories — Requirements for quality and competence
CSA ISO 9001 : 2016 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

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