How can I report an adverse effect following immunization?

Question: How can prescribers satisfy requirements for reporting an adverse event following immunization (AEFI)?

Context: In a separate post, we describe how to report a patient safety event and how to report serious adverse drug reactions. There is another process for reporting an adverse event following immunization (AEFI), defined as an unfavourable health occurrence experienced by a patient that:

• follows immunization
• cannot be attributed to a pre-existing condition
• is determined by a health practitioner to be one or more of the following:
• a life-threatening health occurrence requiring hospitalization or urgent medical attention
• an unusual or unexpected health occurrence not previously identified, or previously identified but of increasing frequency
• a health occurrence that cannot be explained by the patient's medical history, recent disease, illness or use of a medication

All AEFIs must be reported to the AHS Provincial AEFI team. By completing the AEFI form within Connect Care, the team is automatically notified; no further notification to the team is required.

Answer [updated January 2025]: AEFI reports can be completed entirely within Connect Care. From within an opened patient chart, seek the "Serious Adverse Drug Reaction Form" (SADR Form) activity by using Chart Search with "serious" or "reaction" as a keyword. Note the "AEFI Criteria" tab at the top of the SADR Form activity. Select (click on) the “Complete an AEFI report form in Connect Care” link; a “Flowsheet Pop-Up” form will appear. Fill in the form, ensuring the “Patient Aware of Notification” questions are both answered. Add a brief note in the “Notes” sidebar activity.

Once completed and signed, the report is automatically directed to the Provincial AEFI team for review and reporting.

For screenshots, see the tip sheet.

• Tip: Adverse Event After Immunization Reporting

Related postings:

• FAQ: How can I report a serious adverse drug reaction?
• FAQ: How can I report an adverse effect following immunization?
• FAQ: How can I report a medical device incident?
• FAQ: How can I report a patient safety event?

How can I report a Serious Adverse Drug Reaction?

Question: How can prescribers satisfy requirements for reporting serious adverse drug reactions (SADR)?

Context: In a separate post, we describe how to report a patient safety event. Safety threats that specifically relate to serious adverse drug reactions are subject to federal (Health Canada) reporting requirements and so have unique supports within Connect Care.

To be "serious", an adverse drug reaction should cause or potentially cause a:

• hospitalization or prolongation of an existing hospitalization
• congenital malformation
• persistent or significant disability of incapacity
• life threatening situation or death

Answer:  SADR events can be reported from within Connect Care. From within an opened patient chart, seek the "Serious Adverse Drug Reaction Form" activity or use Chart Search with "Serious" as a keyword before jumping to the SADR activity.

Note the "Adverse Drug Reaction Note" in the SADR navigator and create a note. A NoteWriter "SmartForm" will open to highlight the required reporting elements. Any clinician can initiate the SADR report. However, the patient's attending prescriber must complete the indicated section, with details about:

1. The impact of the adverse drug reaction on the patient's health.
2. Any comorbidities which may have affected the impact of the adverse drug reaction.
3. The date on which health was restored (if applicable).

Once completed and signed, the report is automatically directed for review and reporting to Health Canada.

Related postings:

• FAQ: How can I report a serious adverse drug reaction?
• FAQ: How can I report an adverse effect following immunization?
• FAQ: How can I report a medical device incident?
• FAQ: How can I report a patient safety event?

How can I report a Medical Device Incident?

Question: Is there a way for clinicians to submit a device incident report through the Connect Care clinical information system (CIS)?

Context: Medical devices are regulated by Health Canada, which mandates that device-related safety risks be reported. Medical devices include clinical equipment (e.g. IV pumps, ventilators, vitals monitors, etc.) and clinical consumables (e.g., pacemakers, PICC lines, artificial joints, etc.). A device-related event is any incident, or condition that could have resulted or did result in harm to a patient and involves a device or CIS interface to a device. 

Alberta Health Services (AHS) uses a single, province-wide system for device incident reporting. The Medical Device Incidents or Problems (MDIP) reporting system can be accessed directly within Connect Care.

Note that AHS uses is a separate system (Reporting & Learning System for Patient Safety, RLS) for reporting other patient safety events.

Answer: The MDIP device incident reporting system is integrated with the Connect Care CIS. Users can submit a report from within Connect Care. Use the Chart Search function (top right in Hyperspace) to search for "MDIP" then select the appropriate activity where a report workflow is launched. MDIP also appears near the top of the Epic menu structure. 

Be sure to indicate a Connect Care relationship in the comments if it is believed that the device incident relates to an interface to the Connect Care CIS.

• Be sure to check the question “Was digital health technology a factor” as "Yes". 
• If a helpdesk (help.connect-care.ca) service ticket was created, please include the ticket number in the description of the incident. 
• If the device incident was specific to a particular patient care workflow, please add the medical record number (MRN) to the description.
• If available, note the device identification number in the description of the incident. This can be found on an AHS sticker applied to the device.
• QuickReference: Reporting Safety Events Online

If a device issue is urgent, be sure to locate the device sticker number and call 1-877-311-4300.

Related postings:

• FAQ: How can I report a serious adverse drug reaction?
• FAQ: How can I report an adverse effect following immunization?
• FAQ: How can I report a patient safety event?

How can I report a patient safety event?

Question: Is there a way for clinicians to submit a patient safety event or concern through the Connect Care clinical information system?

Context: A patient safety event is an event, incident, or condition that could have resulted or did result in harm to a patient. An event can be, but is not necessarily, the result of a defective system or process design, a system breakdown, equipment failure, or human error. This includes how a clinical information system (CIS) may affect the risk for or handling of an event.

Alberta Health Services (AHS) uses a single, province-wide system for patient safety reporting. The Reporting & Learning System for Patient Safety (RLS) supports a just culture that includes reporting and learning as key elements of quality care. Consistent reporting of hazards, close calls and adverse events is encouraged for the purpose of learning about and improving patient safety throughout the health care system.

Note that AHS uses is a separate system (Medical Device Incidents or Problems, MDIPs) for reporting device-specific malfunctions.

Also note that RLS is used to report blood product safety events, including transfusion reactions.

Answer: The RLS patient safety reporting system is integrated with the Connect Care CIS. Users can describe an event and submit a report from within Connect Care. Use the Search function (top right in Hyperspace) to search for "RLS" then select the appropriate activity where different types of safety events are presented for reporting. RLS also appears near the top of the Epic menu structure. 

Use the "Other Patient Safety Event" category to report safety events that are felt to be attributable to, or aggravated by, any software within the Connect Care CIS. 

• Be sure to check the question “Was digital health technology a factor” as "Yes".  
• If a helpdesk (help.connect-care.ca) service ticket was created, please include the ticket number in the description of the event. 
• If the safety event was specific to a particular patient care workflow, please add the medical record number (MRN) to the description of the event.
• QuickReference: Reporting Safety Events Online

Related postings:

• FAQ: How can I report a serious adverse drug reaction?
• FAQ: How can I report an adverse effect following immunization?
• FAQ: How can I report a medical device incident?
• FAQ: How can I report a patient safety event?