The administration and delivery of healthcare in Canada are the responsibility of each province (state) or territory. POC testing has generally been encouraged by Canadian healthcare providers due to the challenges of servicing large underpopulated areas. This in turn has led to an increased interest by regulation authorities in monitoring the quality of POCT and its implementation. For example, the Ministry of Health and Long-Term Care in the province of Ontario have a very well defined policy, which was updated in 2008.31 This mandatory policy applies to all “licensed hospitals”, including those hospitals “without a licensed laboratory” and to “long-term care homes”. The policy defines the management and technical requirements for POCT under the following categories:
- evaluation of new or alternative POCT instruments and systems
- precision and accuracy requirements to meet clinical needs
- evaluation and approval proposals and protocols
- purchase and installation of equipment
- maintenance of consumable supplies and reagents
- training, certification and recertification of POCT operators
- quality control and quality assurance
- health record management.
Professional organisations involved with the drafting of the Ontario policy were: Ontario Society of Clinical Chemists, Ontario Hospital Association, Ontario Medical Association, College of Physicians and Surgeons of Ontario, College of Medical Laboratory Technologists of Ontario, College of Nurses of Ontario, Ontario Long-Term Care Association, and Ontario Association for Non-Profit Homes and Services for Seniors.
Also on behalf of the Ontario Ministry of Health and Long-Term Care, specific guidelines were prepared in 2009 to cover patients on long-term oral anticoagulation therapy by an expert panel convened by the Ontario Medical Association. These guidelines state; “The target audience was anticoagulation clinics, pharmacies, long-term care facilities, community care services, physician/primary care offices and selected patients and/or caregivers”.32 “Recommendations were proposed following the consideration of INR POC international guidelines, devices licensed by Health Canada, device selection criteria, Quality Control (QC) and External Quality Assessment (EQA) programs, enablers and barriers, and training requirements.” The guidelines specify that:
- QC is required; with a system independent from the manufacturer of the device preferred
- operators must take part in an EQA program in order to validate the test system performance, at a minimum of once per year
- operators monitoring and performing POC INR testing on greater than 10 patients per day, should take part in a formal EQA program.
Similar “policy” guidelines have been established for POC HIV33 and occult blood34 testing.
In contrast to Ontario with its defined policies, the Ministere de la Santé et des Services sociaux in the province of Quebec, commissioned the Agence d’evaluation des technologies et des modes d’intervention en santé (AETMIS), to review the role of POCT with a view to revising legislation and applicable regulations while assessing the need for governance oversight of POCT procedures. In this respect, aspects of Quebec legislation already acknowledge the concept of POCT as the legal definition of POCT is, “testing performed by qualified health professionals outside recognised and accredited public or private laboratories and outside health and social services institutions”.37
The executive summary of the AETMIS report (dated January 2008) provides a good overview of the recommendations.36
Other provinces with less well defined policies still appear to follow recognised guidelines. For example, the College of Physicians and Surgeons of Alberta provide detailed recommendations for the use of POCT outside of an accredited laboratory which includes documentation, staff training, quality control, etc, in Unaccredited point-of-care laboratory testing guidelines for physicians.35