The College of Naturopaths of Ontario (CoNO) has formally launched its Risk-based Regulation (RbR) Program. The program’s purpose is to identify conditions within the profession that present or may present a risk of harm to patients.

Unlike the typical regulatory framework, which reacts to information that is brought forward to or learned by the regulatory body, a RbR Program is intended to be proactive, before any actual harm occurs, through early identification of areas of activity within the practice of the profession that create an existing or potential risk of harm to the public and patients, and the implementation of mitigative measures to reduce or eliminate that risk of harm.

Program Scope

The RbR Program is designed to look at data about the practice of the profession and, through analysis of the data or through a review of data over several years, identify trends within the practice that have or might create a risk of harm to patients.

Once risks are identified, programs can be engaged that work to mitigate those risks. Programming includes quality assurance programming, educational programming, advisory services to the profession and the public or working with our system partners to enable them to use programming at their disposal such as conventions, conferences, and continuing education programming.

Data to Support Risk-based Regulation

CoNO’s RbR Program will be using the following data sets.

Complaints & Reports Data

Data from the complaints and reports program provides an important perspective on risk. While it is demonstrative of an alleged event or peril that may have already occurred, collectively, complaints and reports can indicate trends of issues that are emerging.

Data sets include:

• The number of complaints and number of reports,
• The number of complaints/reports that result in outcomes from the ICRC,
• The degree of severity of outcomes, such as letters of counsel vs Specified Continuing Education or Remediation Programs (SCERPS) vs referrals to discipline,
• The controlled acts involved in the complaints, and
• The standards to which the complaints relate.

Discipline Data

Data from the discipline program is similar in nature to that of the complaints and reports program. For example, the number of referrals to discipline can indicate whether there is a trend towards more serious matters resulting in more referrals to the Discipline Committee. Additionally, discipline subject matter can indicate the seriousness of complaints and reports, and trends in disciplinary subject matter can identify areas where College programming can provide information and clarity to the profession to reduce future complaints in the same areas. Discipline outcomes can be used to assess risk severity based on the allegations.

Data sets include:

• The number of referrals,
• Discipline outcomes,
• The degree of severity of outcomes, such as letters of counsel vs SCERPS vs referrals to discipline,
• The controlled acts involved in the matters,
• The standards at issue in the matters, and
• Breaches of the various regulations at issue.

Inspection Program Data

CoNO is one of only four regulatory colleges in Ontario that operates an inspection program. There is some basic information that can provide helpful data to a RbR approach, including:

• Number of premises registered that offer IVIT services which could indicate the cumulative risk to Ontarians, i.e., the greater the number of IVIT premises, the greater the cumulative risk that a peril may occur.
• Inspection outcomes which collectively may be indicative of the degree to which the profession is able and willing to comply with the standards.

The program also offers more sophisticated information based on requirements set out in the General Regulation that registrants file occurrence reports.

Data sets include:

• Number of registered premises, the number of premises closing, and new premises being registered.
• Number and nature of type 1 occurrences.
• Type 2 occurrence data, which can indicate trends in several areas including changes in usage of IVIT authorized substances, and issues surrounding compliance with premises standards.
• Number of cease & desist letters sent to registrants who have not met the standard of practice for providing IVIT in premises as well as the number of cease & desist letters sent to unregistered clinics to stop providing IVIT.
• Inspection outcomes.

Registration Program Data

The Registration program is the backbone of CoNO, both in terms of a core function of registering qualified naturopaths but also in terms of the economic sustainability of the College. Basic information about the number of registrants, the success of the annual renewals and attrition rate is used to forecast the future economic conditions facing the College. Related data, such as administrative suspensions and revocations support this process.

Data about referrals to the Registration Committee (RC) can provide indications of new and emerging risk exposure trends given the changing nature of the profession.

Data sets include:

• Class changes, referrals to the RC (i.e., individuals Inactive for more than 2 years seeking to resume practise of the profession) and the outcomes of RC reviews.
• Number of entry-to-practice referrals to the RC and why those are being made and are they indicative of the character of the profession on a whole.
• Currency data on registrants, which may provide information about how current and how competent the profession is, its financial health and future compliance in other areas.

Registrant Activities Data

Beginning with the 2024 renewal year, CoNO began collecting data from all registrants to determine the number of practitioners who are performing medium-risk or high-risk activities. Registrants were required to indicate whether they perform any of the following controlled acts:

• Moving the joints of the spine (manipulation),
• Puncturing the dermis (acupuncture),
• Internal Examinations,
• Administering substances by inhalation,
• Administering substances by non-IVIT injection,
• Administering substances by IVIT,
• Prescribing a drug,
• Dispensing a drug,
• Compounding a drug (including for IVIT),
• Selling a drug, and
• Taking blood samples for performing prescribed naturopathic exams.

This information will allow the College to understand the extent to which the profession is performing the restricted acts to which they have been authorized by legislation. This is important quantifying data when considering risks to the public.

Additionally, registrants have been asked about the size of their practice (number of patients in their practice) and the number of patients seen (number of patient visits) in the past year. This information is intended to give the College a sense of the scope of risk.

Finally, the College obtained information from registrants about the nature of the practice of the profession and can identify trends over time. It can also be used to cross reference other risk data to determine whether risk is increased based on the type of practice.

Quality Assurance Data

CoNO is very much aware of the legislative requirements that silos Quality Assurance Program information; however, this siloing pertains to individual registrant information. The Quality Assurance Program can still provide data that is relevant to the RbR Program.

Data sets include:

• Self-assessment participation levels,
• CE Reporting compliance,
• Peer & Practice Assessment (PPA) outcomes, and
• Standards identified in PPAs for added work by registrants.

Examination Data

CoNO currently delivers three entry-to-practice examinations and two post-registration examinations for extended services. Through these examinations, College can identify:

• Modalities that pose challenges for examination candidates,
• Conditions that may not have been considered,
• Competencies that may need additional focus, and
• Specific procedures that require additional work.

Regulatory Guidance and Education

Regulatory Guidance is a service provided by CoNO that provides support to registrants and the public to understand the regulatory framework.

Data sets include:

• The number of inquiries received,
• The topics of the inquiries,
• The Standards discussed during discussions, and
• The regulations discussed during discussions.

Therapeutic Prescribing Standard

CoNO has advised all registrants that beginning in 2025, registrants who have met the Standard of Practice on Therapeutic Prescribing will be required to track specific data over the course of 2025 and to be prepared to report that data to the College in early 2026.

Data sets include:

• Number of drugs prescribed, dispensed, compounded, and sold,
• Number of adverse drug reactions encountered,
• Nature of the drug reactions,
• Number of substances administered by inhalation and injection,
• Number of adverse reactions from these, and
• Nature of the adverse reactions.

Data Review and Analysis

In support of the RbR Program and the process to identify risks and mitigation techniques, CoNO has established the Working Group on the Identification and Mitigation of Patient Harm (WGIMPH). The WGIMPH will work collaboratively to identify and mitigate risks of harm to Ontario Naturopathic patients by:

• Receiving and analyzing data from CoNO’s RbR Program,
• Identifying current and potential future risks of harm to Ontario naturopathic patients based on trends identified in the data,
• Recommending programs to mitigate those risks of harm to patients, collectively and in collaboration with individual member organizations,
• Reporting on identified risk trends to member organizations, to patients and to Ontario’s Naturopathic Doctors; and
• Monitoring the success of CoNO’s RbR Program and recommending methods to ensure total quality improvement of the validity and reliability of the data.

Invitations to participate have been sent to the College’s system partners to begin considering the data available in this Program.

Outcomes and Reports

The primary focus of RbR is to establish various tracks of information sharing with the profession. The idea behind this is simply that with information, the profession can adjust practises that may pose a risk of harm to patients. For example, if the RbR Program identified consent practices as being an area of risk, education opportunities or articles or bulletins from any of the system partners would raise awareness of consent practices to allow registrants to re-evaluate their existing practices and make the necessary changes to reduce the potential risk to patients.

It is also intended that a report will be issued by the WGIMPH highlighting the areas of risk found and the potential programming that can address the risks.