Quality Assurance
Statement of Quality Assurance
Hemostasis Reference Laboratory maintains a Total Quality Management System that monitors performance throughout the laboratory. We are
accredited by the
College of American Pathologists, and 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:
- HRL works to the requirements of the international
standard:
◊
ISO
15189:2003:
“Medical laboratories — Particular requirements for quality and
competence”.
-
HRL was deemed by an international
private regulator to be in compliance with GLP/GMP standards.
-
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)].
-
All procedures are clearly written and follow the format of
the Clinical and Laboratory Standards Institute (CLSI formerly
known as
NCCLS).
- 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).
- 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).
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