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The Laboratory and Blood Services Standards apply to organizations that provide laboratory and blood services, and are to be used in conjunction with the Laboratory Analyses Standards and/or the Blood Bank and Transfusion Services Standards.
The Laboratory and Blood Services Standards are based on Canadian Standards Association (CSA) Standards Z15189-03 and Z902-04, and the companion document “Plus 15189: The ISO 15189:2003 Essentials” written by the CSA in 2004. These standards enable an organization to evaluate its activities related to planning, designing, providing, and evaluating human resources, space, equipment, and services provided to internal and external end users of laboratories and blood services.
This standard section covers the following subsections:
Planning and designing services (CSA Z5189-03, clauses 4.1.1 to 4.1.4, 4.5 to 4.7 / Z902-04 clause 4.1.2), including managing contracts to provide services to or receive services from other departments and/or organizations.
Being responsive to clients and service providers including using an interdisciplinary approach to providing services and coordinating services with other providers, services, organizations, and/or sectors.
Having the right people (CSA Z15189-03 clause 5.1 / Z902-04 clause 4.3.2), including ensuring staff competence.
Complying with good laboratory practice (CSA Z902-04 clauses 4, 19, 20 / Z15189-03 clauses 4.3, 4.13, Annex B, Annex C), including complying with legislation, regulations, ethical principles, Standard Operating Procedures (SOPs), document control, and laboratory information systems.
Providing a suitable environment (CSA Z15189-03 clause 5.2 / Z902-04 clause 21), including verifying laboratory space, design, and environmental conditions.
Operating and maintaining laboratory instruments (CSA Z15189-03 clause 5.3 / clause Z902-04 clause 22), including the design and maintenance of laboratory instruments.
Using supplies, reagents, and media including preparation, handling, labelling, and storage.
Keeping the laboratory safe including management and staff responsibilities, safe design, identifying hazards, reporting incidents, and ensuring compliance with requirements for personal protective equipment (PPE) and good housekeeping.
Being a learning organization and achieving positive outcomes (CSA Z15189-03 clauses 4.1.5, 4.2, 4.9 to 4.12, 4.14 to 4.15 / CSA Z902-04 clauses 4.6 and 17) including quality control and proficiency testing, best practice and benchmarking, quality improvement, and best results.
Accreditation Canada clients receive the standards as part of their accreditation program.
Non-clients can purchase the standards online.
$100 per set of standards.Order five sets or more and receive a 20% discount.
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