DNA Testing Laboratories (Sample Collection Sites for DNA Relationship testing program)
Action required
Revised requirements to be adopted as soon as possible for the DNA testing forensic laboratories participating in the field of DNA Relationship testing program for Immigration, Refugees and Citizenship Canada (IRCC).
Affected customers
SCC-accredited testing laboratories within the field of DNA Relationship testing.
Background
On July 31st 2018, Immigration, Refugees and Citizenship Canada (IRCC) clarified its requirements for the process of collecting DNA samples. Accordingly, the sample collection sites shall be administered by an SCC-accredited laboratory when located within Canada. Outside of Canada, DNA samples shall be collected in the presence of a migration officer or migration office staff member and the package with the DNA samples shall be sent to the testing laboratories by the fastest, most reliable means possible. SCC Accreditation Services Bulletin #2018-10 was released on 29 August 2018 to ensure that DNA sample collection and reporting are conducted in line with IRCC guidelines.
The DNA sample collection site should be considered a supplier of service and meet the requirements of ISO/IEC 17025:2017, clause 6.6 “Externally provided products and services”. These collection sites should be evaluated and monitored by the laboratory like any other supplier that impacts quality of services. The criteria to select, monitor performance and re-evaluate the sites are required. The laboratory shall maintain a list of collection sites that it has approved before engaging them in sample collection activity.
Furthermore, the suppliers, partners, and subcontractors shall satisfy the same requirements that the laboratory itself is required to meet by having corresponding contracts which cover all the relevant requirements, including at least:
- Specification of responsibilities and tasks related to sample collection;
- Obligations related to the transfer of relevant information between both partners; and,
- Traceability of collection samples and records.
SCC has become aware of some sample collection sites that have made claims that could mislead the general public into believing that the laboratory is SCC-accredited and conducting business in this field. This has caused some confusion and extra correspondence from Canadian Government offices in other countries to confirm the validity of these claims.
New requirements
SCC requires accredited laboratories under the DNA relationship testing program used for immigration purposes to have legally binding clauses in their contracts with all sample collection sites with whom they are affiliated to impose limitations on the advertising of their SCC-accredited status or claims of accreditation. The collection sites are required to disclose the name of the affiliated accredited laboratory in all their communications to the donor and IRCC offices.
Accredited laboratories under the DNA relationship testing program are listed on SCC’s website.
Sample collection sites used by SCC-accredited laboratories under the DNA relationship testing program shall not be permitted to claim accreditation through their laboratory affiliation.
SCC-accredited laboratories shall maintain a current list of collection sites and their accreditation status, if applicable. This list should be readily available upon request.
SCC-accredited laboratories shall ensure through appropriate monitoring that the sample collection sites are consistently meeting the requirements of ISO/IEC 17025:2017, clause 6.6, otherwise they may have their accreditation status suspended.
Deadline
The new requirements shall be adopted with immediate effect.
Questions?
Please contact Abdel Kassou, Manager, Compliance and Assessment Services, at abdel.kassou@scc-ccn.ca or +1 613 238 3222 for more information.