Accreditation for laboratory medicine facilities
The Diagnostic Accreditation Program is the regulatory accreditation body for laboratory medicine diagnostic services in BC. We ensure availability of accreditation services to all diagnostic facilities and apply all policies and procedures in a non-discriminatory manner.
DAP ISO 15189 accreditation scheme
This accreditation scheme is mandated (required) for facilities that are high volume or high complexity.
This includes facilities:
- that provide a high volume of testing for patients in BC, or
- whose scope of accreditation consists of high-complexity diagnostic services.
For all other facilities, participation in this scheme is voluntary. Email dap@cpsbc.ca to participate in the ISO 15189 accreditation scheme.
Details on the framework guiding facility participation in the DAP ISO 15189 scheme
Accreditation body for ISO 15189 in BC
The DAP is a signatory to the Mutual Recognition Arrangement of the Asia Pacific Accreditation Cooperation (APAC) for the accreditation standards ISO 15189.
ISO accreditation is an international standard that provides a framework for laboratories to generate consistently valid and reliable test results in support of patient care.
As a signatory member of the APAC MRA, DAP is recognized as providing ISO 15189 accreditation. Facilities accredited through the DAP ISO 15189 scheme are then recognized by ILAC signatory bodies, just as DAP recognizes the accreditation status from other ILAC signatories.
The DAP ISO 15189 accreditation scheme is aligned to comply with the:
- international standard ISO/IEC 17011: 2017 General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies, and
- ILAC guidelines for assessment bodies
The DAP’s signatory status:
- facilitates acceptance of testing results that permit DAP ISO 15189 accreditation to be recognized by ILAC signatory bodies, and
- permits the DAP to recognize the accreditation status of the ILAC signatory bodies.
The DAP has aligned its accreditation cycle to comply with
- the international standard ISO/IEC 17011:2017 General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies, and
- ILAC guidelines for assessment bodies.
The College of Physicians and Surgeons of BC Diagnostic Accreditation Program ISO 15189 seal is a legally protected asset of the College of Physicians and Surgeons of BC.
Only medical laboratories that are accredited through the DAP ISO 15189 scheme are entitled to use the accreditation symbol. The symbol is to be used in accordance with the requirements provided to accredited facilities upon receipt of accreditation.
How the assessment works
Diagnostic facilities accredited by the DAP will have an on-site assessment conducted every four years to the DAP ISO 15189 standards and all applicable DAP core standards.
Following a successful assessment and resolution of all nonconformances, an accreditation certificate is issued for five years.
The DAP will reassess the service to the full set of DAP ISO 15189 and applicable DAP core standards in 46-48 months of the previous full assessment.
Diagnostic facilities accredited to DAP ISO 15189 will have a mid-cycle on-site assessment at the two-year point of their accreditation term.
A mid-cycle assessment focus includes:
- all requirements that have been deemed “critical" and "high risk"
- the requirements with the highest non-conformance rates
- any new or changed requirements
Focused assessments occur when a lab adds new services or equipment.
Accreditation awards are specific to the scope of services that were observed at the time of assessment. The existing accreditation award can be expanded to include the new diagnostic service upon successful completion of a focused assessment.
A focused assessment uses a narrow standard set that addresses patient and staff safety, and facility equipment validation prior to offering a new diagnostic service.
Relocation assessments are required if the facility moves to a new location.
The relocation assessment uses a focused standard set addressing patient and staff safety and facility equipment validation prior to offering patient services. The new location must successfully meet the assessment standards before the accreditation award can be transferred from the old location to the new location.
