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Accreditation
Requirements and Guidance Information
Program requirements
are based on the following International Organization for Standardization
(ISO) standards:
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ISO 15189:2007 Medical laboratories — Particular requirements for quality and competence
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ISO 15190:2003 Medical laboratories – Requirements for safety
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ISO 22870:2006 Point-of-care testing (POCT) – Requirements for quality and competence
In addition, these
Canadian national standards are also fully addressed:
Requirement development was aided by cross-referencing
these standards to generally
accepted principles of good practice in Ontario. As a result, additional
documents are also referenced:
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Canadian
Statues and Regulations (for laboratories located outside Canada, local
regulations apply)
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Provincial
Statutes and Regulations
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Health
Canada Guidelines
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Standards
and guidelines achieved through consensus by international, North
American, Canadian and provincial associations, federations,
organizations and regulatory bodies.
Each accreditation
requirement has an accompanying reference source. Additional good practice
recommendations are included with the requirements.
Accompanying each requirement and good practice recommendation is “What To Look For” guidance information that explains the intent of the requirement and provides insight into its application. Usually, this guidance information is phrased as a question, and may include an indication of documents and records required to meet the requirements. Discipline-specific technical detail is incorporated within the requirements as “What To Look For” guidance, and represents application of the requirements to individual discipline practice. This discipline specific information encompasses key details that the peer assessors will consider, but it should not be considered all-inclusive. Individual assessors apply their own knowledge and expertise when assessing whether a laboratory meets requirements.
The Ontario Laboratory Accreditation (OLA) Requirements and Guidance Information are available to accreditation applicants and accredited laboratories through QView?. The posted files may be accessed with a username and password by logging into QView? at
www.qmpls.org. Assistance with login may be obtained by contacting
ola@qmpls.org. Other parties may purchase them through the Institute for Quality Management in Healthcare (IQMH). Please visit IQMH online at
www.IQMH.org to learn more.
Revisions/Review
of the Requirements
A review of requirements occurs every year. Supporting reference sources are reviewed, updated and their impact (if any) on the wording of requirements is assessed to determine the necessity for a new version of the requirements. At minimum, a new version of the requirements is released once every three years. Any laboratory may offer suggestions regarding the suitability of a requirement at any time, ongoing feedback is recorded and reviewed regularly. The OLA Advisory Panel investigates and addresses challenges as needed.
Feedback
Your feedback is welcome.
Submit your feedback using our online feedback
form.
Or download a PDF version of the feedback form to
complete offline.
Contact
Information
Quality Management Program — Laboratory Services
Telephone: 416-323-9540,
FAX: 416-323-9324
ola@qmpls.org
Revised: 2010-07-07
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