The Council of the College of Physicians and Surgeons of Ontario (the "CPSO") has approved a regulation regarding the inspection of premises where certain medical procedures are performed ("Proposed Regulation"). Through amendments to Ontario Regulation 114/94, promulgated under the Medicine Act, 1991, the Proposed Regulation would create a mechanism by which the CPSO may oversee and inspect certain non-hospital premises. The Proposed Regulation is now with the Government of Ontario and the CPSO expects it to come into force later this year.
This bulletin is intended to be a high-level overview of key elements of the Proposed Regulation. It is not intended to be a complete summary of the Proposed Regulation. We invite readers to contact the author for more information.
Purpose of the Proposed Regulation
According to the CPSO, the Proposed Regulation was developed in response to a growing number of patients attending non-hospital facilities for cosmetic or non-cosmetic procedures alike. The CPSO says that some safeguards typically in place in hospitals may not necessarily exist in non-hospital facilities. Further, it says that regulatory controls imposed under the Independent Health Facilities Act do not apply to many facilities because this Act applies only to facilities that both provide insured services and are permitted to bill facility fees to the government.
The legislature has enacted s. 95(1)(h.1) of the Health Professions Procedural Code, being Schedule 2 to the Regulated Health Professions Act, 1991, S.O. 1991, c. 18 (the "Code"). This new subsection empowers the Council of a College, subject to the approval of the Lieutenant Governor in Council, to make regulations "providing for the direct observation of a member in his or her practice, including the direct observation by inspectors of procedures, during the course of an inspection or examination provided under clause (h)." Clause (h) empowers the Council to make regulations "requiring and providing for inspection and examination of premises used in connection with the practice of the profession and of equipment, books, accounts, reports and records of members relating to their practices."
Highlights of the Proposed Regulation
Through the Proposed Regulation, any premises where a member performs or may perform a procedure on a patient would be subject to inspection. The Proposed Regulation would not, however, apply to certain health care facilities governed by or funded under several named statutes, such as hospitals, independent health facilities and nursing homes.
The procedures captured by the Proposed Regulation would be those performed under the administration of general anesthesia, parenteral sedation or regional anesthesia and, with exceptions, an act performed with the administration of a local anesthetic agent.
Under the Proposed Regulation, the CPSO would be entitled to require any or all of the following as part of its inspection of a premises:
- inspection, examination or tests regarding any equipment, instrument, materials or any other thing that may be used in the performance of a procedure;
- examination and copying of books, accounts, reports, records or similar documents that are, in the opinion of the CPSO, relevant to the performance of a procedure in the practice of the member;
- inquiries or questions to be answered by the member that are relevant to the performance of a procedure on a patient; and
- direct observation of a member in his or her practice, including direct observation by an inspector of the member performing a procedure on a patient.
Under the Proposed Regulation, members whose premises are subject to an inspection would have a duty to:
- submit to an inspection of the premises where he or she performs or may perform a procedure on a patient;
- promptly answer a question or comply with a requirement of the inspector that is relevant to the inspection; and
- cooperate fully with the College and the inspector who is conducting an inspection of the premises.
After an inspection of a premises, the CPSO would determine, in accordance with the accepted standards of practice, whether a premises "passes", "passes with conditions" or "fails".
The timing of the inspections is specified in the Proposed Regulation.
On the date the Proposed Regulation comes into force, a member whose practice includes the performance of a procedure on a patient in any premises, as defined in the Proposed Regulation, must provide notice to the CPSO within 60 days from the date the Proposed Regulation comes into force. The CPSO must ensure that an inspection of such premises takes place within 24 months from the date the Proposed Regulation comes into force.
A member who would like to begin to perform procedures on a patient in any premises, as defined in the Proposed Regulation, must first give notice to the CPSO and the premises must pass an inspection or pass an inspection with conditions. The CPSO must ensure that an inspection takes place within 180 days of receiving the member's notice.
All premises where a member performs or may perform a procedure on a patient are subject to an inspection by the CPSO once every five years after its initial inspection, or more often, if, in the opinion of the CPSO, it is necessary or advisable to do so.
The Proposed Regulation seeks to ensure patient privacy and autonomy.
As noted above, an inspector may, as part of an inspection, seek to observe a member in his or her practice or to observe the member performing a procedure on a patient. Before the observation can occur, the inspector must obtain the patient's written consent to the direct observation of the patient by the inspector, amongst other things.
A copy of the Proposed Regulation is available at www.cpso.on.ca.