Quality Assurance

Statement of Quality Assurance
Hemostasis Reference Laboratory maintains a Total Quality Management System that monitors performance throughout the laboratory. We meet the standards of the Health Protection Branch of Canada, the Food and Drug Administration of the United States and work to the ISO 15189 Standard for medical laboratories.

Our Total Quality Management System includes the following quality assurances:

1. HRL works to the requirements of the international standard:
   ◊ ISO 15189:2003: “Medical laboratories — Particular requirements for quality and competence”.
   
   
2. HRL was deemed by an international private regulator to be in compliance with GLP/GMP standards.
   
   
3. HRL was audited and found to be compliant with Good Clinical Practice standards (GCP), as defined by the International Committee on Harmonization (ICH), and accepted by the FDA [Federal Register on May 9, 1997 (62 FR 25692)].
   
   
4. All procedures are clearly written and follow the format of the Clinical and Laboratory Standards Institute (CLSI formerly known as NCCLS).
   
   
5. Laboratory Quality Control:
   
   ◊ Internal quality control follow Westgard rules. ◊ External Proficiency Testing Programs;
   - The College of American Pathologists (CAP).
   - The Ontario Quality Management Program - Laboratory Services (QMP-LS).
   
   
6. HRL MLT technologists are licensed by the College of Medical Laboratory Technologists of Ontario (CMLTO) and registered with the Canadian Society for Medical Laboratory Science (CSMLS).