Accreditation and TheDNALab
Did you know that TheDNALab, which is solely owned and operated by Maxxam Analytics, was the first private laboratory in Canada to be accredited under the forensic specialty standard of the Standards Council of Canada? Further, unlike some other DNA laboratories, TheDNALab has never lost its accreditation status.
To understand the importance of accreditation, let’s dive deeper into what exactly accreditation is, why it’s essential, and how a laboratory becomes accredited.
What Is Accreditation?
Accreditation is the formal recognition by an accreditation body that an organization is competent to perform specific tasks—the tasks that they are accredited for. Accreditation is voluntary.
The Standards Council of Canada (SCC) is a federal crown corporation and is Canada’s national Accreditation body. Established in 1970, the SCC’s main purpose is to promote and administer voluntary standardization in Canada. More than 500 organizations from around the world, including TheDNALab, are accredited by the SCC.
On January 31, 2000, TheDNALab became the first private laboratory in Canada to be accredited to the SCC’s forensic-speciality standard (currently titled Requirements and Guidance for the Accreditation for Forensic Testing Laboratories). This accreditation also includes compliance to the general testing standard (ISO/IEC 17025, currently titled General Requirements for the Competence of Testing and Calibration Laboratories). Since that time, TheDNALab has always maintained its accreditation to these two standards. TheDNALab has been routinely re-audited on nine occasions (2001, 2003, 2005, 2007, 2009, 2011, 2013, 2015 and 2017) and has always maintained SCC accreditation status.
SCC’s Forensic Specialty standard: Requirements and Guidance for the Accreditation for Forensic Testing Laboratories
The SCC’s forensic specialty standard contains requirements supplemental to the requirements detailed in the general testing standard (see next paragraph below). It specifies the requirements for the competence to carrying out forensic analysis and examination. Examples include laboratories performing blood alcohol tests, firearm examinations, DNA analysis on crime-scene evidence, as well as DNA laboratories performing DNA analysis for relationships (paternity, maternity, grandparent, avuncular, and sibship tests).
General testing standard: General Requirements for the Competence of Testing and Calibration Laboratories
This is an international standard, published jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), for the testing and calibration laboratories. It specifies the general requirements for the competence to carry out tests, calibrations, and sampling.
Access to the above standards can be found at the following links:
SCC’s Forensic speciality standard – https://www.scc.ca/en/about-scc/publications/scc-requirements-and-guidance-for-accreditation-for-forensic-testing-laboratories
General testing standard – https://www.scc.ca/en/node/113785
One the SCC’s customers is the Forensic Science and Identification Services of the Royal Canadian Mounted Police (RCMP), Canada’s national police service, who provide body fluid testing, DNA testing, and other forensic services to the RCMP and other police agencies in Canada. They are accredited to the same standards as Maxxam’s DNA laboratory.
Why Is Accreditation Important?
Becoming accredited provides assurance that a laboratory’s activities (ex. DNA analysis for a Paternity test) comply with practices and standards that are recognized internationally and nationally. Complying with recognized standards helps ensure that the testing methods used by the laboratory are reliable and that the laboratory can be trusted to provide accurate test results.
For forensic DNA laboratories, whose main activities include the testing of physical evidence, DNA testing, relationship testing, issuing reports, and providing testimony in court, accreditation to the SCC forensic specialty standard becomes an imperative step to demonstrate that DNA test results have proven and documented credibility.
TheDNALab routinely produces DNA test results (paternity, maternity, grandparent, avuncular, and sibship tests) for our clients. Such DNA tests affect decisions concerned with their quality of life, and thus have a significant importance to the client. To ensure that we produce quality data for all of our clients we follow a set of recognized and widely accepted requirements and guidelines for the procedures and results involved in the DNA testing process.
Through SCC accreditation to the forensic specialty standard and the general testing standard, TheDNALab is recognized to be able to obtain quality, reliable, and credible DNA test results for customers. TheDNALab has been recognized by the SCC to be competent in the following activities:
- Examination of evidentiary material for the presence of biological material and potential biological material
- Human DNA testing services for verifying identity in paternity cases, claimed biological relationship matters in civil and criminal investigations
- Quantitation of Human DNA. Screening, examination and analysis of unknown substances to determine whether they are of human or non-human origin
The following techniques are incorporated: case screening, item handling, examination for biological material and potential biological material, sample preparation, extraction, Y-STR and Autosomal STR DNA PCR amplification, capillary electrophoresis, analysis, genotyping, interpretation and reporting and court testimony.
Accreditation Process for DNA Laboratories
Accreditation involves the following steps
The laboratory completes and submits an SCC application package detailing information on the operations of the laboratory, what accreditation standards they are applying for, and some basic information.
SCC performs a review of the application package and associated documents to see whether the laboratory meets the requirements of the accreditation standards they applied for. If there are any non-conformities, the SCC will contact the laboratory and request that the laboratory address the non-conformities and submit a response.
An SCC assessment team (typically includes a lead Assessor, other assessors, technical experts, and observers) will visit the laboratory over a pre-arranged period of days. There will be opening and closing meetings with the SCC assessment team and the laboratory staff, interviews with some of the staff, and a review of laboratory activities and the laboratory records.
Once the assessment is complete, the laboratory will receive a findings report which outlines any non-conformities. The laboratory will then have specified period of time to address the non-conformities. This typically involves the submission of an initial plan of actions followed by supporting evidence.
At the time that all nonconformities have been addressed to the satisfaction of the SCC lead assessor, the SCC assessment team prepares a final accreditation report. The report will indicate whether or not the SCC assessment team believes the laboratory met the requirements for accreditation.
Independent Review and Granting Accreditation
An independent review team will then review the accreditation report and other supporting documentation to determine whether the SCC assessment team’s decision regarding whether or not the laboratory meets the requirements for accreditation, is justified.
The independent review team will then make a recommendation to the SCC Vice President of Accreditation Services, as to whether or not they believe the laboratory meets the requirements for accreditation. The SCC Vice President of Accreditation Services (or a delegate) will review the recommendation, along with the accreditation report and other supporting documentation, and make the official/final decision as to whether or not to grant accreditation (or continued accreditation, for an already accredited laboratory)
If the laboratory finds the accreditation decision unjustified, they have the option to submit a written appeal.
If the laboratory is granted accreditation, a scope of accreditation is provided to the laboratory which is the official detailed statement of activities for which the laboratory is accredited, and recognizes that the laboratory is competent to perform the activities defined in the scope. To view our scope of accreditation, please click this link: http://palcan.scc.ca/specs/pdf/158_e.pdf
Accreditation Requirements and Maintaining Accreditation
In order to maintain our accreditation status, external assessors from the SCC, as well as assessors from Maxxam’s Quality Assurance department, routinely assess TheDNALab to ensure all applicable requirements are met, including whether all technical and interpretive staff have the education, experience and training commensurate with their position. For example, TheDNALab is audited on-site every two years by the SCC. The audit process is similar to the process of becoming accredited (documentation review, on-site assessment of activities and records, findings report, accreditation report, etc.; See the Accreditation Process for DNA laboratories section for more information). Further, TheDNALab provides documentation to the SCC every year regarding internal audits and proficiency testing during an annual surveillance survey.
The qualifications of all DNA laboratory staff must meet the SCC’s forensic speciality standard requirements. This includes having an appropriate combination of academic and/or professional qualifications, internal and external training, including training in courtroom procedure and expert witness testimony, experience and skill, as appropriate to their position.
Examples of some additional requirements for maintaining accreditation to the SCC’s forensic specialty standard and/or the general testing standard include sections, such as:
The laboratory shall:
- Control/maintain all documents pertaining to the testing methods used and recording of results
- Document complaints as well as the investigations/corrective actions taken as a result of the complaints
- Document the work performed for each case (from case receipt to reporting) such as records of the receipt of samples, procedures followed, instrumentation used, DNA test results and conclusions
- Conduct and document reviews of all case files
- Use validated methods for producing DNA results
- Maintain limited and controlled access to the operational area of the laboratory. Visitor access to the operational areas of TheDNALab should be restricted a record should be retained of all visitors to the operational areas of the laboratory
- Participate in proficiency testing; all analysts are tested semi-annually, either internally or
- Maintain a ‘chain of custody’ record for legal cases. The ‘chain of custody’ record indicates each person who takes possession of an item and/or the location of that item from time of item/sample collection to return of the items/samples.
TheDNALab Added Bonuses
TheDNALab is solely owned and operated by Maxxam Analytics (Maxxam), which has been the sole external forensic biology and DNA testing contractor to the Royal Canadian Mounted Police (RCMP) since 2001. The Maxxam DNA laboratory processes a variety of forensic biology and DNA related criminal cases for police agencies across Canada. In order to maintain this relationship with the RCMP, the RCMP requires that Maxxam maintains its accreditation to the SCC’s forensic specialty standard and the general testing standard. For this reason, RCMP assessors conduct their own on-site audits of the Maxxam DNA laboratory every year. The RCMP’s audit process is similar to the SCC’s audit process.
All Maxxam DNA laboratory staff that perform current contracted and non-contracted paternity testing services are full time qualified employees. Management provides technical and scientific personnel with the opportunity to stay abreast of new developments and issues within the field of DNA analysis through access to online resources, current journals or other literature, through attendance at continuing education courses, seminars and symposiums and retraining.
As issued by Public Works and Government Services Canada (PWGSC), the Maxxam DNA laboratory currently holds a valid organization security clearance (which encompasses the facility, information system infrastructure and personnel). Further, all personnel within the laboratory hold current, valid security clearances issued by the RCMP. These clearances are at the level of Enhanced Reliability/Protected A status and accordingly, the Maxxam DNA laboratory has provisions necessary to protect the identity, integrity, condition and security of any test item and to protect the interests of the laboratory and the customers. These provisions have been established to protect against loss/theft, unauthorized access, disclosure, copying, use or modification of collected personal information and ensures that all data generated by the Maxxam DNA laboratory will be defensible.
Technological measures are also required, including username, password combinations and encryption for data management and electronic communication—such as emailed results using the Co-Sign digital tool. Co-Sign is a digital signature that locks a PDF file from unauthorized revisions. Should an attempt be made to alter the electronic report, the scientist’s signature will be revoked and cannot be re-inserted. A report that is absent of the scientist’s signature is deemed a non-legal document.
The Maxxam DNA laboratory also has a unique numerical system for identifying all test items. This identification is retained throughout the life of the item in the laboratory. This system is designed to ensure that items cannot be confused physically or when referred to in records or other documents. Each case is contained within its own file, separate from and unique to all other files.
All laboratory staff have their DNA profile on file. This database is used as a control measure to ensure that contamination by a staff member has not occurred during the processing of an item.
The Maxxam DNA laboratory does not utilize the laboratory services of independent (sub) contractors, volunteers, students, trainees or work placements.
Accreditation and Citizenship and Immigration Canada (CIC)
According to Citizenship and Immigration Canada (CIC), applicants pursuing DNA relationship testing (ex. in sponsorship cases; for proof of paternity, maternity, and a sibling relationship) must obtain DNA test results from a DNA laboratory that is accredited to the forensic-speciality standard, which TheDNALab maintains accreditation to.
TheDNALab is the first accredited DNA laboratory authorized by Citizenship and Immigration Canada to carry out DNA tests for immigration purposes. TheDNALab has held our relationship with CIC since 1999.
For more information about our accreditation or DNA Test services, please do not hesitate to contact us.
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