Reporting Type 2 Occurrences
Type 2 occurrences are incidents that may or did result in harm to a patient in relation to the performance of compounding for or administering by Intravenous Infusion Therapy (IVIT). Registrants are required to document all Type 2 occurrences in the patient file as they happen and may use the Type 2 Occurrence Tracking form to record the information related to the occurrence.
Part IV of the General Regulation defines Type 2 occurrences as:
- Any infection occurring in a patient in the premises after an IVIT procedure was performed at the premises.
- An unscheduled treatment of a patient by a Registrant occurring within five days after an IVIT procedure was performed at the premises.
- Any adverse drug reaction occurring in a patient after an IVIT procedure was performed at the premises.
An adverse drug reaction is defined as a harmful and unintended response by a patient to a drug or substance or combination of drugs or substances that occurs at doses normally used or tested in humans for the diagnosis, treatment or prevention of a disease or the modifications of organic function.
Reporting Type 2 Occurrences
The Designated Registrant for each premises must report Type 2 occurrences to the College on an annual basis (no later than May 1) using the Type 2 Occurrence Annual Report form. The reporting period runs from March 2 to March 1.
Once the College receives the annual Type 2 occurrence reports, the data is provided to both the Inspection Committee and the Council of the College for information and planning purposes. The Inspection Committee considers the information in the context of any developing trends that may indicate that more information should be given to the premises and Registrants performing IVIT to address potential deficiencies. The information is also used in the context of reviewing the standards that govern premises with the intent of strengthening public safety.