Inspection Program FAQs

The College of Naturopaths of Ontario conducts inspections of all premises where IVIT procedures are performed in accordance with Part IV of the General Regulation (O. Reg 168/15).

These questions and answers are intended as general guidance to the most common questions regarding the Inspection Program. The information is not legal or practice advice and are not intended as such. For more detailed information please refer to the relevant statutes, regulations, standards, policies and requirements.


Index of Questions

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A. Registering an existing IVIT Premises
1. I don’t do IVIT in my clinic but I do B12 i.m. injections, will I have to have an inspection?
2. If I compound botanicals that aren’t listed on Table 2 of the General Regulation, do I have to have an inspection?
3. How can I register the premises?
4. What if the premises where I perform IVIT services isn’t registered with the College before the 60-day registration period is over?


B. Registering a new IVIT premises
5. When do I have to register a new premises that has never offered IVIT?
6. Why is the inspection for a new premises conducted in two parts?


C. Inspection Program Fee

7. If I work in two clinics do I have to pay an inspection fee for both premises?
8. Who has to pay the inspection fee?
9. Why do the inspectors get $2,500 to do an inspection that only takes a day?


D. Inspection Program Processes
10. How are the premises chosen for the existing premises inspections?
11. Can I defer the inspection?
12. How do I submit a change of premises address for the Inspection Program, if I move my clinic location?
13. How and when will the inspection be scheduled?
14. What if I believe that the inspector assigned to inspect my premises has a bias against me due to something in the past and because of that, the premises will not receive a fair inspection?


E. Inspectors
15. Who are the inspectors?


F. Inspection Program Requirements
16. Do I have to make my premises wheelchair accessible?
17. I am the only ND in the clinic; how do I form a Quality Management Committee?
18. Can you tell me the exact specifications for the laminar air flow hood that I should install?


G. Type 1 and Type 2 Occurrences
19. What are Type 1 and 2 occurrences?
20. What does the College do with information about occurrences?
21. When do I have to report a Type 1 occurrence?
22. When do I have to report a Type 2 occurrence?


H. The Inspection
23. How long after I register the premises will the inspection take place?
24. There are a number of NDs who provide IVIT services at the premises but on different days, will they all have to be observed performing compounding and IVIT?
25. Will I have to accompany the inspector during the inspection?
26. I see that part of the inspection includes a review of patient files. Who picks these files?


I. Inspection Outcomes
27. Who decides the outcome of the inspection?
28. What happens if the inspection passes but with “conditions?”
29. What happens if the premises where I work fails the inspection?
30. What happens if I work at two premises and one fails the inspection?
31. What are the criteria to determine an outcome of a fail?

 

Answers 


A. Registering an existing IVIT Premises

1. I don’t do IVIT in my clinic but I do B12 i.m. injections, will I have to have an inspection?
No. The Inspection Program only applies to premises where intravenous injections and compounding for IVIT are performed. If NDs at your clinic ONLY do non-IV injections then the premises will not be included in the Inspection Program.

2. If I compound botanicals that aren’t listed on Table 2 of the General Regulation, do I have to have an inspection?
If you only prepare remedies such as a mixture of botanicals for oral use and do not provide any IVIT services, i.e. compounding for IVIT or administering by IVIT, then the premises where you practise will not be included in the Inspection Program.

3. How can I register the premises?
The designated member must register a premises by completing and submitting the “Registering an IVIT Premises Form,” which will be posted in the Handbooks, Tools and Forms section of the College’s website as of March 2, 2017. The form can be completed electronically and submitted by email, or it can be printed, completed by hand, and submitted by mail or fax or scanned and submitted by email. 

4. What if the premises where I perform IVIT services isn’t registered with the College before the 60-day registration period is over?
All premises that are offering IVIT services on or before May 1, 2017 and do not submit a Registering an IVIT Premises Form to the College by midnight on May 1, 2017, must stop IVIT procedures immediately (that is, administering by IVIT and/or compounding for IVIT). 

In order for the premises to begin to offer IVIT services again, the designated member would need to register the location as a new premises. This means the designated member must submit the Registering an IVIT Premises form, after which the premises will undergo Part I of the inspection and must receive an outcome of a pass or pass with conditions in order to allow the premises to offer IVIT procedures.

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B. Registering a new IVIT premises

5. When do I have to register a new premises that has never offered IVIT?
It is up to the designated member of the premises to register the premises whenever they feel they have met the requirements to be able to compound for IVIT and/or administer by IVIT. Once a new premises has been registered, it must undergo Part I of the inspection process and achieve a pass or a pass with conditions before being permitted to provide IVIT services.

The College has an obligation to conduct Part I of the inspection of a new premises within 180 days of the premises being registered. Whenever possible the College will endeavour to conduct the inspection as soon as possible after a new premises submits the Registering an IVIT Premises Form.

6. Why is the inspection for a new premises conducted in two parts?
There are many Inspection Program Requirements that must be in place before IVIT procedures are to be performed. In the interest of public safety, Part I of the inspection will ensure that these program components are being met and that procedures can begin to be offered. Some Inspection Program Requirements require the observation of compounding for IVIT and the administration by IVIT, which can only be done once the premises has been performing the procedures for a number of months. 

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C. Inspection Program Fee

7. If I work in two clinics do I have to pay an inspection fee for both premises?
If you are the sole ND practicing IVIT services at both premises then, yes, you will have to pay the full inspection fee for both premises. If there is more than one ND practicing IVIT at any of the premises where you provide IVIT services, then it is up to the NDs at each location to determine if or how they might split the cost of the fee.

8. Who has to pay the inspection fee?
The designated member is responsible for remitting the inspection fee to the College. It is up to the Members practicing in the premises as to how the fee will be paid among them.

9. Why do the inspectors get $2,500 to do an inspection that only takes a day?
The cost of the inspection covers more than just the cost of the inspector’s time and expenses. The inspection fee also pays for the honoraria and expenses of the Inspection Committee members, as well as, the legal, administrative and staff costs of running the program and supporting the inspectors and committee members.

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D. Inspection Program Processes

10. How are the premises chosen for the existing premises inspections?

Once all the existing premises are registered, the locations to be inspected will be randomly chosen and scheduled so that the College may meet the requirement of inspecting all existing premises before May 2, 2019.  The College has the option, in an effort to be cost efficient and to make the most effective use of the inspector’s travel time, of scheduling inspections on consecutive days for premises in smaller communities which only have a few premises.

11. Can I defer the inspection?
The designated member may make a request for a deferral within 14 days of receipt of the notification of an inspection by completing the Deferral Request form which will be posted in the Handbooks, Tools and Forms section of the College’s website. 

Circumstances that may allow for a deferral include, for example, parental leave, serious illness, or the designated member on a leave of absence at the time. 

The College will consider a deferral request and its supporting documentation in a fair and objective manner, and make a determination based on the individual situation. A written notification of the decision will be provided regarding the deferral request. If a request is granted and an additional deferral is required, a new request must be submitted.

12. How do I submit a change of premises address for the Inspection Program, if I move my clinic location?
If you move your practice location to a premises that is not currently performing IVIT procedures, the new location is considered to be a new premises. It must undergo the “new” premises registration process of first being registered with the College, undergoing Part I of the inspection, and receiving an outcome of a pass or pass with conditions allowing the premises to offer IVIT procedures.

13. How and when will the inspection be scheduled?
The designated member will receive a letter to inform them of a pending inspection and a request to complete the forms that will provide information such as days and times that IVIT procedures are performed and type of record keeping used (EMR vs paper).  Following receipt of this information, the College will assign an inspector to the premises and notify the designated member of the inspector’s name. The inspector will then contact the member within 30 days to schedule the inspection as soon as possible on a date when IVIT procedures are being performed.

14. What if I believe that the inspector assigned to inspect my premises has a bias against me due to something in the past and because of that, the premises will not receive a fair inspection?
Prior to assigning an inspector to a premises, both the designated member and the inspector will complete a Declaration of a Conflict of Interest form. The form allows both members to provide information to the College about any relationships between the members at the premises and a possible inspector that may constitute a conflict of interest. The College will review the information and ensure that the inspector assigned to inspect the premises is not in a conflict of interest so that a fair and objective inspection will be conducted. 

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E. Inspectors

15. Who are the inspectors?
Inspectors are Members of the College who have the authority to perform IVIT, have submitted a resume, cover letter and references, have undergone an interview with College staff and successfully completed a two-day inspector training session.

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F. Inspection Program Requirements


16. Do I have to make my premises wheelchair accessible?


Accessibility requirements for all clinics, not only IVIT premises are contained within the Accessibility for Ontarians with Disabilities Act. The requirements encompass accommodations made not just for people with physical disabilities but also for those with a condition of mental impairment or a learning or developmental disability among other conditions. 

The requirements that are specific to allowing access for people with physical disabilities apply strictly to new or redeveloped/renovated public spaces. For more information about your business’s responsibilities click here [link to https://www.ontario.ca/page/accessibility-laws].

17. I am the only ND in the clinic; how do I form a Quality Management Committee?
If there are other staff members in the clinic who provide IVIT related patient services then they are expected to be part of the committee. As the only ND you may want to consider contacting an ND who provides IVIT services at another premises and work with them when conducting the review of patient care and files.

18. Can you tell me the exact specifications for the laminar air flow hood that I should install?
The Laminar Air Flow Hood Policy does not dictate the specifics of the laminar air flow hood that is to be purchased and installed for a premises. It is the responsibility of the IVIT qualified Members at each premises to determine the style and specifications of the hood that are most appropriate for their practice.

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G. Type 1 and Type 2 Occurrences


19. What are Type 1 and 2 occurrences?

Type 1 and Type 2 occurrences are serious events related to IVIT procedures that happen to a patient of which the College must be informed. Sections 24 and 25 of Part IV of the General Regulation as well as the Inspection Program Handbook list the Type 1 occurrences (such as, the death of a patient at the premises after an IVIT procedure was performed or a procedure being performed on the wrong patient) and the Type 2 occurrences (such as an infection or an adverse drug reaction occurring after an IVIT procedure).

20. What does the College do with information about occurrences?
Type 1 information - is to ensure that the College is aware when a serious incident happens in a clinic.
Type 2 information - is for statistical purposes.

21. When do I have to report a Type 1 occurrence?
All Type 1 occurrences must be reported to the College on the Type 1 Occurrence Report form within 24 hours of learning of the event. The reporting requirement applies to all NDs not just those who performed the IVIT procedure. 

22. When do I have to report a Type 2 occurrence?
Type 2 occurrences are to be reported by the designated member to the College on an annual basis. The first reporting date will be May 1, 2018. Reminders will be sent out prior to the reporting date and will include how they will need to be submitted. It is advisable for every premises to compile the occurrences as they happen in order to be able to readily provide the information to the College each year.

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H. The Inspection


23. How long after I register the premises will the inspection take place?

For a premises that is considered to be an existing premises, that is, it has been providing IVIT services and is registered by or before May 1, 2017, the inspection must be completed before March 2, 2019, according to Part IV of the General Regulation. Members will be notified of a pending inspection approximately 2-3 months prior to the inspection being conducted.

For a new premises, which is a premises that will begin to offer IVIT services for the first time, or will resume offering IVIT services and did not register by May 1, 2017, Part IV of the General Regulation requires the College to conduct Part I of the inspection within 180 days of the premises being registered (see also Q&A #5). If the premises receives a pass or a pass with conditions that allows them to provide IVIT services, Part II of the inspection will be conducted 4-6 months later.

24. There are a number of NDs who provide IVIT services at the premises but on different days, will they all have to be observed performing compounding and IVIT?
No. In a premises where there is more than one ND who performs IVIT services, not all NDs who perform IVIT services will be observed. On the day of the inspection, the IVIT services will be observed by the ND who is scheduled to perform the procedure on the day of the inspection.

25. Will I have to accompany the inspector during the inspection?
The designated member for the premises should schedule approximately 30 minutes at the beginning of the inspection so that the inspector can be introduced to the staff and respond to any questions. Approximately 45 minutes will be needed at the end of the inspection for the inspector to review his/her observations with the Member and ask any questions they may have. The inspector will conduct the majority of the inspection without the need of a staff member at his/her side. However the Member is to remain on site to provide any additional information that the inspector may need.

26. I see that part of the inspection includes a review of patient files. Who picks these files?
The designated member will be informed that in preparation for the inspection they are to have selected eight to ten (8-10) files that reflect the IVIT practice of the premises. For a premises where there is more than one IVIT ND, there should be at least one file selected for each ND. If there are NDs at the premises that do not practice IVIT their files are not to be among the 8-10 selected.

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I. Inspection Outcomes

27. Who decides the outcome of the inspection?
The Inspection Committee determines the outcome, whether it is a pass, pass with conditions or a fail, of all inspections. The Committee will consider the information provided in the inspector’s report along with any additional information received, such as an accompanying submission from the Designated Member, when deciding the outcome. The outcome and the reasons for the outcome are provided in writing to the designated member of the premises.

The Inspection Committee is made up of two IVIT qualified members, one of whom is also a member of Council, plus one public Council member.

28. What happens if the inspection passes but with “conditions?”
In most cases when there are conditions, the premises will be able to continue providing IVIT services. For example, if the Policies and Procedures Manual is found to be incomplete the premises may continue providing IVIT services but is expected to address the deficiencies found in the manual. It is possible, however, that the conditions could restrict part of the IVIT services that are being provided until such time as the designated member makes a submission and can demonstrate to the satisfaction of the Inspection Committee that the identified deficiencies have been rectified. Depending on the conditions and what remedies must be in place, an additional inspection may be required. 

29. What happens if the premises where I work fails the inspection?
You must stop providing IVIT services at the premises upon receipt of the outcome of a fail. The premises can then make a submission to the College within 14 days after receiving the outcome to demonstrate changes have been made in an effort to rectify the deficiencies that resulted in the outcome of a fail. 

The Inspection Committee will consider the submission and then has the following options:
Issue a pass or a pass with conditions that would permit the premises to resume IVIT procedures; or
Require a second inspection within 60 days of receiving the submission (the cost of which is to be paid by the premises), after which the Committee may confirm the outcome of a fail or issue a pass with conditions or a pass; or
Confirm the outcome of a fail, at which point the premises may only resume offering IVIT procedures after registering as a new premises, undergoing Part I of the inspection and receiving an outcome of a pass or pass with conditions that allows the premises to offer IVIT procedures. 

30. What happens if I work at two premises and one fails the inspection?
You must stop providing IVIT services at the premises that has failed the inspection but may continue to provide IVIT services at the other premises. It is the premises that has failed the inspection not the Members working at the premises.

The Member can continue to provide non-IVIT procedures, i.e. other naturopathic care, at a premises that has failed an inspection.

31. What are the criteria to determine an outcome of a fail?
A fail outcome can result where the Inspection Committee believes that placing conditions on a premises is likely not going to be sufficient to eliminate a serious risk of harm to patients. For example, potentially, in the case of a premises where both compounding and administration practices lack the procedures to prevent contamination and potential patient infection, the Committee may determine that a failure is warranted. 

Premises that receive an initial outcome of a fail have 14 days in which to make a submission for the Inspection Committee to consider and possibly alter the outcome to a pass with conditions or a pass.
 
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