Laboratory medicine

Laboratory medicine is the clinical science devoted to the quantitative measurement or qualitative assessment of human specimens to support patient care. This may include whole blood, serum, plasma, urine and body fluids.

Why we accredit facilities

Accreditation ensures quality, competence and safety through conformance to an acknowledged standard. Accreditation can lead to improved quality of service. It also provides formal recognition that the facility meets industry best practices.

Ensuring quality, competence and safety

The DAP 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.

The DAP does not:

  • provide competing services
  • offer consultancy services
Accreditation scheme

The accreditation scheme employs program specific standards developed by the DAP using international best practices and expert consensus through the program’s advisory committees. Staff and peer assessors with appropriate knowledge of the scope of accreditation are chosen to assess the diagnostic facility to the DAP standards.

Rights and obligations

The Health Professions Act and the College Bylaws outlines and describes the rights and obligations of the DAP as an accreditation body.

An accreditation agreement stating the terms of accreditation must be signed by the diagnostic service medical director as part of each assessment and when there is a change of diagnostic service medical director.

The accreditation agreement explicitly states the College’s expectations of the medical director within the College Bylaws.

Hybrid (peer and staff-based) assessment methodology

What assessors do

The use of system and patient tracers allows for the assessment of the laboratory’s performance as staff conducts sample collections and analysis.

The assessors are required to observe and assess the full scope of service that occurs at the facility, including:

  • transfusions
  • point-of-care testing at the bedside
  • embedding in anatomic pathology

The assessors will also visit any sample collection sites as per the facility assessment schedule.

The assessors follow specific assessment protocols that direct their assessment activities. The protocols provide direction to the assessors by outlining what to ask, observe and assess. The use of protocols also assists to increase the objectivity and consistency among assessors. It allows for comments, observations and recommendations to be recorded.

Regional assessment model

A regional assessment model will be employed where facilities have common governance, including:

  • oversight of the quality manual
  • safety program
  • human resource management
  • quality management system

Regional assessments are conducted to reduce the duplication of work when multiple facilities in the same regional system are required to provide the same evidence.

  • A comprehensive assessment to the DAP organizational standards will be conducted at a primary site
  • Conformance to regional standards will be sampled at each related facility

Monitoring laboratory PT performance

Medical laboratories in BC are required to participate in proficiency testing (PT) programs and alternative assessment procedures that reflect their range of accredited services.

The DAP maintains its own records of laboratory PT performance, including the outcomes of investigations and subsequent corrective actions.

PT performance history will be a factor considered when determining the overall accreditation award. Medical laboratories are required to investigate and comment on unacceptable performance in writing to the DAP within a designated timeframe. Corrective actions that are initiated by the laboratory require monitoring to ensure they are effective.

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How we accredit facilities

Facilities require provisional accreditation prior to opening and operating in BC. No diagnostic facility may operate without an accreditation award. The provisional accreditation certificate is valid for up to two years. The DAP will reassess the diagnostic service to the full set of applicable standards within one year of the initial assessment.

Diagnostic facilities accredited by the DAP will have an on-site assessment conducted every four years. Diagnostic facilities pursuing accreditation to ISO 15189 will receive a mid-cycle on-site assessment added at the two-year point of their accreditation term.

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.

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 "immediate" and "high risk"
  • the requirements with the highest non-conformance rates
  • any new or changed requirements

Useful links

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.

Evaluates and establishes accreditation standards for the performance of diagnostic services
Advises DAP staff and the DAP Committee on medical, technical and management issues
Conducts on-site assessments of diagnostic facilities and services

DAP ISO 15189 accreditation

The accreditation scheme employs program-specific standards developed by the DAP using international best practices and expert consensus through the program’s advisory committees.

The laboratory medicine program has fully integrated ISO 15189 into the standards set.

The DAP assesses both new and existing facilities

All new facilities, and some new services within an already accredited facility, must go through the...
Accreditation assessments are scheduled every four years. Any nonconformances identified at the...