Z316.7-12 (R2022)

Overview

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.

CSA Group acknowledges that the development of this Standard was made possible, in part, by the financial support of Alere Inc., BD — Canada (Preanalytical Systems), the Canadian Society for Medical Laboratory Science (CSMLS), the Clinical Laboratory Management Association Trillium Chapter, Copan Diagnostics, Covidien, Greiner Bio-One North America, Inc., Thermo Fisher Scientific, and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, the Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).

This Standard was inspired by the following documents produced by the Ordre professionnel des technologistes médicaux du Québec (OPTMQ):

(a) Prélèvement de sang par ponction capillaire aux fins d’analyse, 3rd ed. (2011);

(b) Prélèvement de sang par ponction veineuse pour fins d’analyse, 6th ed. (2006); and

(c) Transport et conservation des échantillons dans le domaine de la biologie médicale, 4th ed. (2010).

This Standard was prepared by the Subcommittee on Specimen Procurement, under the jurisdiction of the Technical Committee on Medical Laboratory Quality Systems and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee.

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.