Syantra Q&A with Karen Matthews
“CPSA accreditation helps patients know that quality and safety are top priorities for medical and diagnostic facilities.”
The vast majority of medical decisions made by a physician for a patient are based on the results of diagnostic tests. These results impact patient care pathways, treatments and outcomes. It’s not surprising, then, that being accredited to offer a diagnostic test is a big deal. A very big deal.
Last year, when Syantra Inc. earned its College of Physicians and Surgeons of Alberta (CPSA) Lab Accreditation for its precision medicine breast cancer screening test, it was the culmination of years of research, focus and intent. It was also a nod to the guidance and support of Karen Matthews, who has helped to guide Syantra through the regulatory steps necessary to bring Syantra DX | Breast Cancer to market. Here’s what she had to say about her role, the CPSA accreditation and the importance of continuous improvement.
What is your role at Syantra?
My role as a Quality and Regulatory Affairs Consultant at Syantra is to help the team understand rules and regulations, develop processes and documents, and implement the various requirements needed in order to meet, or exceed, the many varied requirements for the different accrediting bodies, such as ISO 13485 and CPSA.
For most regulatory bodies, the basis of their requirements is a strong, well-established, and well-controlled Quality Management System (QMS) that ensures the laboratory produces high-quality results, services or products, and demonstrates a commitment to quality. Being accredited by provincial and national accrediting bodies opens doors globally to be able to provide services all around the world.
What is the College of Physicians and Surgeons of Alberta?
The College of Physicians and Surgeons of Alberta (CPSA) is… responsible for the oversight of the practice of medicine in Alberta, including all diagnostic laboratory services. It’s a trusted voice in the Alberta healthcare system, which works collaboratively with the Minister of Health, the government and members of the public.
Alberta laboratories that perform and report diagnostic tests to guide patient care must be accredited by CPSA, which is responsible for writing facility accreditation standards and assessing these facilities. CPSA also encourages the development of a culture of continuous improvement, quality assurance and safety within these organizations. Accreditation helps patients know that quality and safety are top priorities for medical and diagnostic facilities.
Syantra’s lab is CPSA accredited. What does that mean for physicians and patients?
It means that Syantra has satisfied all of the standards and requirements that are provided by the CPSA and has been designated as an “accredited laboratory”. This gives physicians and patients the assurance that the quality and safety of the results provided are meeting high quality and safety requirements.
How did Syantra achieve accreditation?
The CPSA has a set of general standards that apply to all laboratories, as well as a discipline-specific set of standards for each laboratory discipline…Syantra is assessed to the general standards as well as the molecular diagnostics and genetics standards.
CPSA conducts an on-site assessment in a peer-review process when a facility first opens, and then reassesses the facility on a four-year cycle… Facilities are also reassessed if the location moves, adds a new service, renovates or if a concern is brought forward to the CPSA.
How do CPSA accreditation criteria stack up against those of other provinces?
CPSA is part of the Western Canada Diagnostic Accreditation Alliance, so the standards are similar to those used in Saskatchewan and Manitoba under their own provincial College of Physicians and Surgeons.
CPSA standards are very comprehensive. Their Diagnostic laboratory Standards are recognized as among the highest in the world by the International Society for Quality in Health Care External Evaluation Association (IEEA).
Are the standards around CPSA accreditation routinely audited? If so, how will Syantra ensure excellence in maintaining those standards?
Continued improvements, quality assurance and continued auditing of processes are all part of maintaining accreditation readiness for the laboratory. There are numerous systems in place from managing documents and records to safety and facility maintenance as outlined in the Quality Management System. There are processes in place for internal assessments and annual reviews of the QMS to continually identify Opportunities For Improvement (OFIs) in order to improve… The CPSA standards themselves undergo an annual review and periodic updates. Prior to an on-site accreditation, the updated versions are customized and provided to the facility ahead of the scheduled actual on-site visit.
