Central to every task undertaken at Gamma-Dynacare is a commitment to the highest level of clinical and scientific quality. Our patients and clients deserve no less. This commitment is a cornerstone of our success and greatly influences all aspects of our company, from our training and development to our technologies, clinical procedures and service.
Quality Management
Gamma-Dynacare serves a diverse client base that includes community physicians and patients, hospitals, occupational health and wellness providers, clinical trial sponsors, naturopaths and insurance companies. Our in-depth understanding of regulatory requirements and service expectations for each client sector that we serve has been a key contributor to our sustained growth.
Integral to all Gamma-Dynacare operations is our extensive Quality Management System (QMS). We take a proactive approach to QMS design, establishing programs on an ongoing basis to ensure that we meet the evolving needs of our diverse client base as well as increasingly stringent regulatory requirements. Key components of our QMS include the following:
- Management review, quality planning and reporting;
- Internal corporate quality audit programs;
- Specimen acceptability protocols;
- Equipment control programs that encompass inventory, validation, maintenance, calibration and decommissioning protocols;
- Use of leading edge software to monitor quality control of analytical processes;
- Preventative and corrective action programs;
- Change control and computerized systems validation in compliance with US Food and Drug Administration (FDA) 21 CFR Part 11 requirements;
- Document and record control systems;
- Purchasing and inventory control processes;
- External Quality Assessment (EQA) programs to verify the accuracy of methods against peer groups. EQA programs cover all assays and include CAP, QMP-LS, Healthmetrix surveys as well as trace metals and toxicology EQA programs;
- Proactive monitoring of key indicators to assess the performance of processes against quality requirements and service level standards;
- Application of process improvement and planning tools to ensure processes put in place are robust and reliable; and
- Training, development, continuing education and competency assessments.
In addition, we incorporate best practices recommended by key external organizations, including the Clinical Laboratory Standards Institute (CLSI), the American Association of Blood Banks (AABB), the National Academy of Clinical Biochemistry (NACB) and Cancer Care Ontario. Gamma-Dynacare actively participates in the Ontario Medical Association’s Quality Management Program – Laboratory Services (QMP-LS), with representatives serving on scientific committees, the senior management advisory council and expert panels as well as in the role of inspectors.
The quality management programs across Gamma-Dynacare’s network are regularly assessed by regulatory agencies and accreditation organizations. For more information, please visit the Licences and Accreditations section of this web site.
Quality Leadership
Gamma-Dynacare has a well-established record of industry leadership in quality performance. Achievements during the past decade include:
2008
- Our Montreal laboratory became the first in Canada to receive ISO 15189 accreditation
- Gamma-Dynacare introduced an internal pathology peer review program to monitor indicators of pathologist performance in this field of interpretive medicine
- Gamma-Dynacare was selected to lead the Laboratory Quality Assurance Secretariat for Canada’s first province-wide colorectal screening program established by the Ontario Ministry of Health and Long-Term Care and Cancer Care Ontario
- Gamma-Dynacare was selected by the Government of New Brunswick to conduct a major independent review of more than 21,000 pathology cases handled by local hospitals between 1997 and 2007
2004
- Gamma-Dynacare's laboratory at 4040 Finch Avenue in Toronto, Ontario, achieved the first 100% score in the Ontario Laboratory Accreditation (OLA) program. Perfect scores were subsequently achieved at several other Gamma-Dynacare locations
- Gamma-Dynacare worked with a software development firm to create customized, state-of-the-art quality control software that interfaces to all analyzers and our Laboratory Information System. This has facilitated our ability to monitor Quality Control results across locations and apply the most current best practices in Quality Control
2001
- Gamma-Dynacare became the first community laboratory to introduce the routine use of liquid-based cervical cytology, which reduces the number of unsatisfactory specimens and improves detection of abnormalities
- Gamma-Dynacare’s Director of Corporate Quality Programs received the Bob Cardno Award from the American Society for Quality