CSA Z316.7-12 (R2022)

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.