All hospitals operating and providing medication management services to patients in public and private hospitals in Ontario must be accredited and undergo routine assessments by the College.
During a hospital pharmacy assessment, a College hospital operations advisor reviews the hospital pharmacy’s operations. The assessment is designed to ensure the hospital pharmacy is adhering to hospital operations standards and has the proper processes and procedures in place.
Currently hospital pharmacies undergo routine assessments every one to two years, depending on the activities performed at the hospital pharmacy and the risk of harm those activities pose to the public.
The reason and outcome of assessments can be found on Find a Pharmacy or Pharmacy Professional.
Assessment Criteria
The assessment will be conducted using the following criteria:
- Hospital Pharmacy Assessment Criteria
- Hazardous Sterile Preparation Assessment Criteria
- Non-Hazardous Sterile Preparation Assessment Criteria
- Non-Sterile Preparation Criteria
Assessment Types
There are several types of assessments that may take place at a hospital pharmacy.
Routine assessments
All hospital pharmacies undergo routine assessments every one to two years, depending on the activities performed at the hospital pharmacy and the risk of harm those activities pose to the public. For example, a hospital pharmacy engaged in non-hazardous or hazardous sterile compounding will be assessed more often than a hospital pharmacy where these activities are not occurring.
New opening and new opening follow up assessments
All hospital pharmacies are assessed and given authorization to operate (accredited) prior to opening day. Additionally, a hospital operations advisor will conduct a follow up assessment within six months after opening. To apply for a hospital pharmacy certificate of accreditation, please visit Opening a Hospital Pharmacy.
Acquisition or amalgamation assessments
A change in corporate ownership resulting in a new corporation number is equivalent to opening a new hospital pharmacy and may require an assessment before opening day. This is similar to assessments that may occur at the time of a merger or amalgamation.If an acquisition or amalgamation is taking place at the hospital, please visit Acquisition or Amalgamation – Hospital Pharmacy.
Relocation assessments
A change in location (if an existing hospital pharmacy moves to a new address) also requires an assessment before opening day. Hospital pharmacies may also require an assessment as a result of a significant renovation.
Re-assessments and re-assessments ordered by the Accreditation Committee
Re-assessments may be ordered by the College hospital operations advisor or may be escalated and ordered by the Accreditation Committee. Re-assessments are scheduled depending on the severity of the issues identified during the previous assessment, the potential time required to fix any deficiencies, and the risk of harm to the public. See below for more information about assessment outcomes and details regarding the re-assessment process.
Assessment Outcomes
The College’s hospital operations advisor uses operational assessment criteria to assess hospital policies and procedures to determine if it is operating safely, or if further action is required.
There are several potential outcomes, depending on what the hospital operations advisor observes at the time of the assessment.
Pass
If no notable issues are identified at the time of the assessment, the hospital pharmacy receives a Pass and the assessment is complete.
If only minor issues are identified at the time of the assessment, the hospital pharmacy is granted the opportunity to rectify the issues. The hospital operations advisor will follow up to ensure they are satisfied that the issues have been addressed. The hospital pharmacy then receives a Pass and the assessment is completed. Usually, the time frame to rectify the issues is 30 days, but could be longer depending on the issue.
Re-assessment required
If issues that have the potential to affect public safety are identified at the time of the assessment, the hospital operations advisor may choose to order a re-assessment and a re-visit of the hospital pharmacy will occur to ensure that all issues are rectified.
When a hospital operations advisor re-visits the hospital pharmacy:
- If no notable issues are identified at the time of the re-assessment, the hospital pharmacy receives a Pass and the assessment is complete.
- If only minor issues are identified at the time of the re-assessment, the hospital pharmacy is granted the opportunity to rectify the issues (as above under “minor issues”). Assuming all issues are rectified, the hospital pharmacy will receive a Pass and the assessment is complete.
- If issues that have the potential to affect public safety are identified at the time of the re-assessment, the hospital will be referred to the Accreditation Committee for further consideration (see below). Hospital pharmacies that are awaiting review by the Accreditation Committee have an outcome of Referred to Accreditation Committee Find a Pharmacy or Pharmacy Professional.
Referred to Accreditation Committee
If there are potential public safety issues, the College may refer the hospital pharmacy to the Accreditation Committee. Pharmacies that are awaiting review by the Accreditation Committee have an outcome of Referred to Accreditation Committee on the Find a Pharmacy or Pharmacy Professional.
Hospital pharmacies that are referred will have already undergone a routine assessment and a re-assessment and continue to have challenges satisfying the assessment criteria which then has the potential to affect public safety.
The Accreditation Committee will review the hospital pharmacy’s file, including information provided by the hospital pharmacy as to how they may have resolved or addressed the issues of concern, and may do one or more of the following:
- Determine the hospital pharmacy’s operations to be satisfactory and issue a Pass if they feel that the hospital pharmacy has appropriately addressed the issues identified. The assessment is complete.
- Issue an outcome of Pass with Conditions. The hospital pharmacy will have a list of identified issues where the Committee expects full compliance with the standards at the next assessment. This list is available on Find a Pharmacy or Pharmacy Professional next to the assessment outcome.
- Order a hospital operations advisor to re-assess the hospital pharmacy. If the Committee chooses this option, a hospital operations advisor will return to the Committee with a report and the Committee will decide whether the hospital pharmacy’s operations are now satisfactory (as above in #1) or whether the hospital pharmacy should have conditions on its right to operate (as above in #2), or if further action should be taken. The hospital pharmacy will have an outcome of Pending Committee Report on Find a Pharmacy or Pharmacy Professional while awaiting the committee’s consideration of the re-assessment report from the hospital operations advisor.
The Accreditation Committee may also refer the hospital’s Chief Executive Officer and Pharmacy Director/Manager to the Discipline Committee. A referral to the Discipline Committee is not an outcome of an assessment and usually coincides with either a re-assessment or conditions on the hospital pharmacy’s right to operate. A referral to the Discipline Committee will require the hospital pharmacy’s Chief Executive Officer and Pharmacy Director/Manager to appear before the Committee. The hospital pharmacy itself will stay under the review of the Accreditation Committee.
Assessment Fees
Pharmacies are required to pay a Pharmacy Re-Inspection (Compliance Audit) fee for each re-assessment. See the Schedule of Fees (line 25) for the current fee amount. Pharmacies are also required to pay a Pharmacy Re-Inspection fee for each re-assessment ordered by the Accreditation Committee. See the Schedule of Fees (line 35) for the current fee amount.