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ontario regulation 415/16

made under the

Naturopathy Act, 2007

Made: October 15, 2015
Approved: November 30, 2016
Filed: December 2, 2016
Published on e-Laws: December 5, 2016
Printed in The Ontario Gazette: December 17, 2016

Amending O. Reg. 168/15

(GENERAL)

1. Part IV of Ontario Regulation 168/15 is revoked and the following substituted:

Part iv
inspection of premises where Certain procedures are performed

Interpretation, etc.

23. (1) In this Part,

“designated member” means,

(a) the member designated for a premises in accordance with section 30, or

(b) where only one member performs or may perform a procedure in a premises, that member; (“membre désigné”)

“inspector” means a person designated by the College to carry out an inspection under this Part on behalf of the College; (“inspecteur”)

“premises” means any place where a member performs or may perform a procedure; (“locaux”)

“procedure” means,

(a) any procedure by which any two or more drugs or substances listed in Table 2 or Table 5, in any combination, are mixed, reconstituted, or by any other means made into a customized therapeutic product by a member for the purpose of administration by intravenous injection to a patient, and includes the labelling of such a customized therapeutic product, or

(b) the administration of a customized therapeutic product described in clause (a) by intravenous injection to a patient by a member; (“acte”)

“Type 1 occurrence” means, with respect to a premises,

(a) the death of a patient at the premises after a procedure was performed,

(b) the death of a patient occurring within five days after a procedure was performed at the premises,

(c) any referral of a patient to emergency services within five days after a procedure was performed at the premises,

(d) any procedure performed on the wrong patient at the premises,

(e) the administration of an emergency drug to a patient immediately after a procedure was performed at the premises,

(f) the diagnosis of a patient with shock or convulsions occurring within five days after a procedure was performed at the premises,

(g) the diagnosis of a patient as being infected with a disease or any disease-causing agent after a procedure was performed at the premises, if the member forms the opinion that the patient is or may have been infected as a result of the performance of a procedure; (“situation de type 1”)

“Type 2 occurrence” means,

(a) any infection occurring in a patient in the premises after a procedure was performed at the premises,

(b) an unscheduled treatment of a patient by a member occurring within five days after a procedure was performed at the premises, or

(c) any adverse drug reaction occurring in a patient after a procedure was performed at the premises. (“situation de type 2”)

(2) Anything that may be done by the College under this Part may be done by the Council or by a committee established under clause 94 (1) (i) of the Health Professions Procedural Code.

Standard of practice re procedures

24. It is a standard of practice of the profession that a member who practises the profession in a premises where procedures are performed shall comply with the requirements of this Part with regard to the reporting of Type 1 and Type 2 occurrences.

Reporting of occurrences

25. Every member shall report to the College, in the form and manner required by the College,

(a) every Type 1 occurrence that follows the performance of a procedure in the premises by the member or another member, with the report being provided to the College no later than 24 hours after the member learns of the occurrence; and

(b) the total number of Type 2 occurrences following the performance of procedures, with the report provided to the College by the designated member on an annual basis, together with, for every Type 2 occurrence that involved an infection, the type of infection.

Inspection

26. (1) All premises where a procedure is or may be performed by a member in connection with his or her practice are subject to inspection by the College in accordance with this Part.

(2) In carrying out an inspection of a premises under subsection (1), the College may also require any or all of the following:

1. Inspection, examination or tests regarding any equipment, instrument, materials or any other thing that may be used in the performance of a procedure.

2. Examination and copying of books, accounts, reports, records or similar documents that are, in the opinion of the College, relevant to the performance of a procedure in the practice of the member.

3. Inquiries or questions to be answered by the member that are relevant to the performance of a procedure.

4. Information that establishes whether a member who performs or may perform a procedure in a premises has met the standard of practice set out in section 24.

5. Direct observation of a member in his or her practice, including direct observation by an inspector of the member performing a procedure and performing a procedure on a patient.

Power of inspector

27. An inspector may, on the production of information identifying him or her as an inspector, enter and have access to any premises where a procedure is or may be performed by a member at reasonable times and may inspect the premises and do any of the things mentioned in subsection 26 (2) on behalf of the College.

Duty of member

28. (1) It is the duty of every member whose premises are subject to an inspection to,

(a) submit to an inspection of the premises where he or she performs or may perform a procedure in accordance with this Part;

(b) submit to being directly observed performing a procedure in his or her practice;

(c) promptly answer a question or comply with a requirement of the inspector that is relevant to an inspection under this Part;

(d) co-operate fully with the inspector who is conducting an inspection of a premises in accordance with this Part;

(e) provide the inspector with a copy of any report that was given to the College in accordance with clause 25 (a); and,

(f) co-operate fully with the College in accordance with this Part.

(2) A member shall not perform a procedure at a premises subject to an inspection under this Part where an inspector has been denied entry or access.

Direct observation

29. Where, as part of the inspection, an inspector directly observes the member performing a procedure on a patient, before the observation occurs, the inspector shall,

(a) identify himself or herself to the patient as an inspector appointed by the College;

(b) explain the purpose of the direct observation to the patient;

(c) inform the patient that information obtained from the direct observation, including personally identifiable information about the patient, may be used in proceedings under this Part or any other proceeding under the Act;

(d) answer any questions that the patient asks; and

(e) obtain the patient’s written consent to the direct observation of the patient by the inspector.

Designated member

30. Where two or more members perform or may perform a procedure in a premises, the members shall,

(a) designate a member as the designated member for the premises, and immediately notify the College of the designated member’s identity;

(b) immediately notify the College, on every occasion when a different member is designated as designated member for the premises, of the identity of the new designated member.

Requirements before using premises

31. (1) No member shall commence using any premises for the purpose of performing a procedure unless the member has previously given notice in writing to the College in accordance with subsection (5) of the member’s intention to do so and the premises pass an inspection or pass an inspection with conditions.

(2) The College shall ensure that an inspection of the premises of a member referred to in subsection (1) is performed within 180 days from the day the College receives the member’s notice.

(3) A member whose practice includes the performance of a procedure in any premises on the day this section comes into force shall give notice in writing to the College in accordance with subsection (5) within 60 days from the day this section comes into force, and the member may continue to use the premises for the performance of procedures until such time as the College has inspected the premises and delivered a report in accordance with section 33.

(4) The College shall ensure that an inspection of the premises of a member referred to in subsection (3) is performed within 24 months from the day this section comes into force.

(5) The notice submitted by the member required in subsections (1) and (3) shall include the following information, submitted in the form and manner required by the College:

1. The full name of the member giving the notice and the full name of the owner or occupier of the premises, if he or she is not the member who is required to give notice under this section.

2. The full name of any other member who is practising or may practise in the premises with the member giving the notice.

3. The name of any health profession corporation that is practising at the premises.

4. The full name of any other regulated health professional who is practising or may practise in the premises with a member at the premises, along with the name of the College where the regulated health professional is a member.

5. The full address of the premises.

6. The date when any member first performed a procedure in the premises or the proposed date when any member or another member intends to perform a procedure at the premises.

7. A description of any procedure that is or may be performed by a member or other members at the premises and of any procedure that may be delegated by the member or other members at the premises.

8. A description of any equipment or materials to be used in the performance of a procedure.

9. Any other information the College requires that is relevant to an inspection conducted at the premises in accordance with this Part.

Timing of inspections

32. All premises where a member performs or may perform a procedure are subject to an inspection by the College once every five years after its initial inspection or more often if, in the opinion of the College, it is necessary or advisable to do so.

Results of inspection

33. (1) After an inspection of a premises, the College shall determine, in accordance with the accepted standards of practice, whether the premises passes, passes with conditions, or fails the inspection.

(2) In determining whether a premises passes, passes with conditions or fails an inspection, the College may consider,

(a) the inspection results provided to the College by the inspector;

(b) information provided by one or more members who perform or may perform a procedure in the premises respecting the inspection, including the answers given by them in response to inquiries or questions asked by the inspector;

(c) the information contained in a notice given by a member under subsection 31 (1) or (3);

(d) any submissions made by a member or members practising in the premises that are relevant to the inspection; and

(e) any other information that is directly relevant to the inspection of the premises conducted under this Part.

(3) The College shall deliver a report, in writing and in accordance with section 39 of the Regulated Health Professions Act, 1991, to the designated member for the premises, within a reasonable time after the inspection is completed.

(4) Any report made by the College respecting an inspection of a premises where a procedure is or may be performed shall make a finding that the premises passed, passed with conditions, or failed the inspection and shall provide reasons where the premises passed with conditions or failed the inspection.

(5) Any report made by the College that makes a finding that the premises failed an inspection or passed with conditions is effective on the day when the report is received in accordance with section 39 of the Regulated Health Professions Act, 1991, by the designated member for the premises.

(6) The designated member who receives a report made by the College that finds that a premises failed an inspection or passed with conditions shall promptly provide copies of the report to all members who perform or may perform a procedure in the premises.

(7) A member shall not perform a procedure in a premises that fails an inspection until,

(a) the College delivers a report, in accordance with section 39 of the Regulated Health Professions Act, 1991, indicating that the premises passed a subsequent inspection, or passed with conditions; or

(b) the College substitutes a finding that the premises passed or passed with conditions, after considering the written submissions, if any, under subsection (9).

(8) A member shall not perform a procedure in a premises that passed an inspection with conditions except in accordance with the conditions set out in the report until,

(a) the College delivers a report, in accordance with section 39 of the Regulated Health Professions Act, 1991, indicating that the premises passed a subsequent inspection; or

(b) the College substitutes a finding that the premises passed the inspection, after considering the written submissions, if any, under subsection (9).

(9) A member may make submissions in writing to the College within 14 days from the day the designated member receives the report under subsection (5).

(10) The College may or may not elect to re-inspect the premises after receiving a member’s written submissions, but no more than 60 days after a member provides his or her written submissions, the College shall do one or more of the following:

1. Confirm its finding that the premises failed the inspection or passed with conditions.

2. Make a report and find that the premises passed with conditions.

3. Make a report and find that the premises passed the inspection.

(11) Premises that fail an inspection or pass with conditions may be subject to one or more further inspections within a reasonable time after the College delivers its report, at the request of a member or any other person to whom the College gave the report, or at any time at the discretion of the College.

(12) Where, as a result of an inspection carried out under this Part, a report made by the College finds that a member’s knowledge, skill or judgment is unsatisfactory, the College may direct the Registrar to refer the report to the Quality Assurance Committee.

(13) Where, as a result of an inspection carried out under this Part, a report made by the College finds that a member may have committed an act of professional misconduct or may be incompetent or incapacitated, the College may direct the Registrar to refer the report to the Inquiries, Complaints and Reports Committee.

Commencement

2. This Regulation comes into force 90 days after the day it is filed.

Made by:
Pris par :

Council of the College of Naturopaths of Ontario:
Le Conseil de l’Ordre des naturopathes de l’Ontario :

Tom Ellis

President / Président

Andrew Parr

Registrar / Registrateur

Date made:October 15, 2015
Pris le : 15 octobre 2015

 

 

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