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
While all laboratory services are encouraged to participate in the DAP ISO 15189 accreditation scheme, selected high volume and/or high complexity laboratory services in British Columbia must be accredited to the DAP ISO 15189 scheme in order to operate.
The DAP Committee has mandated participation in the DAP ISO 15189 accreditation cycle for facilities that
- provide a high volume of testing for patients in BC, or
- whose scope of accreditation consists of high-complexity diagnostic services.
Request to participate
Facilities that are not required to participate in the DAP ISO 15189 accreditation cycle are welcome to volunteer for DAP ISO 15189 accreditation through a request approved by the facility medical director.
Accreditation body for ISO 15189 in BC
The DAP is working toward becoming a signatory to the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) and its regional 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 will:
- facilitate acceptance of testing results that permit DAP ISO 15189 accreditation to be recognized by ILAC signatory bodies, and
- permit the DAP to recognize the accreditation status of the ILAC signatory bodies.
To obtain signatory status to the APAC MRA, the DAP will align 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 DAP is undergoing assessment to the standards as part of the process to become a signatory to the MRA.
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
Accreditation awards are specific to the scope of services that were observed at the time of assessment. Facilities seeking to expand their scope of services may be required to participate in a focused assessment to achieve required accreditation.
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. The existing accreditation award is expanded to include the new diagnostic service upon successful completion of a focused assessment.
Accreditation is only valid for the location (physical address) assessed. Relocation of a facility requires application for a relocation assessment.
The relocation assessment uses a focused standard set addressing patient and staff safety and facility equipment validation prior to offering patient services. The existing accreditation award is transferred to the new physical address when the assessment standards are successfully met.