College of Physicians and Surgeons of Ontario - IVF Facility Inspection
Ontario Regulation 114/94
Regulation - LGIC
Bill or Act:
Medicine Act, 1991
Summary of Proposal:
In Ontario, the regulation of health professions is based on a self-governance model. There are 26 health regulatory colleges governing 28 health professions under the Regulated Health Professions Act, 1991 (RHPA) and their respective health profession Acts. Health regulatory colleges operate at arm's length from the provincial government and independently administer their own internal processes.
Under the RHPA and the Medicine Act, 1991, the College of Physicians and Surgeons of Ontario (CPSO) is responsible for governing the profession of medicine in Ontario. Under these Acts, the CPSO has the authority to make regulations on a variety of subject matters, including requiring and providing for the inspection and examination of premises used in the delivery of fertility services, subject to the prior review by the Minister of Health and Long-Term Care and the approval of the Lieutenant Governor in Council.
Summary of Proposal
As part of the Government of Ontario's expansion of in vitro fertilization (IVF) services that began in December 2015, the province is working with the CPSO to ensure patient safety, access and program effectiveness, regardless of whether services are received in a hospital or in a non-hospital fertility clinic. In order to protect patient safety at all fertility facilities, the CPSO is developing a quality assurance and inspections framework for the delivery of fertility services across Ontario.
Currently, only facilities that offer fertility services that are delivered under types of anesthesia or sedation are captured by the CPSO's Out-of-Hospital Premises Inspection Program (OHPIP). Therefore, the CPSO's proposed amendments to Ontario Regulation 114/94, which deal with the OHPIP, will provide the College with the authority to enter and inspect facilities where fertility services are performed, regardless of whether anesthesia or sedation is used.
Major regulatory amendments to Ontario Regulation 114/94 will include the following:
• Addition of three procedures (1. in vitro fertilization, 2. artificial insemination, and 3. sperm cryopreservation and oocyte cryopreservation) to the definition of "procedure" so that a facility performing any act in connection with the identified procedures would be subject to inspection-assessment under the OHPIP;
• Requirement that facilities provide an inspector with requested information such as the Better Outcomes Registry & Network (BORN) reports (which contain analyses and data about pregnancy, birth and childhood in Ontario) or data; and,
• Requirement that hospital-based fertility clinics would be subject to inspection-assessment under the OHPIP.
The proposed regulation was originally circulated to members and stakeholders for feedback between September 21 and November 25, 2016.
To view and respond to the Council-approved, proposed amendments, please use the following link to the CPSO's website: http://policyconsult.cpso.on.ca/?page_id=8895
Alternatively, the CPSO may be contacted with the following information listed below:
Analysis of Regulatory Impact:
March 7, 2017
Comments Due Date:
April 21, 2017
Contact: Wade Hillier, Director Quality Management Division
Telephone: (416) 967-2636
Telephone Toll Free: 1-800-268-7096
Facsimile: (416) 967-2605
Address: College of Physicians and Surgeons of Ontario, 80 College Street, Toronto ON M5G 2E2, Attention: Policy Department