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Disaster Management Act, 2002 (Act No. 57 of 2002)

Notices

Directions on the establishment of a COVID-19 Vaccine Injury No-Fault Compensation Scheme issued in terms of the Act

Schedules

Schedule 3 : AEFI Reporting Options

 

1. The reporting of an Adverse Event Following Immunisation (AEFI) is not a claim for compensation but is a prerequisite for an investigation into causality which may result in a claim.

 

2. Adverse Events Following Immunisation (AEFI) may be reported in any one of the following ways:
• MedSafety Mobile application of SAHPRA
• At the health facility - paper-based forms or app CASE REPORT FORM (CRF) FOR ADVERSE EVENTS FOLLOWING IMMUNISATION (AEFI)
• On the COVID-19 hot line 0800 029 999

all of which methods are reported through [email protected] to the Vigilance Hub, which is managed by SAHPRA and visible to the National Department of Health, as a common data base of AEFI.

 

3. The reports are classified as:
• Minor - no further investigation
• Severe trigger event
o minor outcome - no further investigation
o serious outcome
▪ admission
▪ disability (temporary or permanent)
▪ death
▪ congenital birth defect

 

4. A reported AEFI Case Report Form (AEFI CRF) is submitted to the health establishment whose investigators use a Case Investigation Form (CIF) to collect details related to the vaccination and the event.

 

5. The results from the investigation are submitted to the NDOH and become part of the running 'line list' for the province.

 

6. The completed CIF, accompanied by the full dossier of patient information, is submitted to NISEC where the (online) 'Worksheet for AEFI Causality Assessment' is followed to determine causality. Those cases where the injury is "Consistent with causal association to immunisation" must be reported to the Scheme Administrator in the Department for the eligible person to be informed who may submit a claim for compensation at the same time as the feedback is provided on outcome to the provincial DOH for clinical follow-up.

 

Compensation Claim

 

7. A duplicate of the full package from NISEC must be submitted to the Scheme Administrator within 28 days of the conclusion of the NISEC assessment.

 

8. The Administrator must contact the claimant to:
8.1 advise the person that they may lodge a claim;
8.2 if the person chooses to lodge a claim, obtain consent for sharing the package of clinical investigation results with the Adjudication Panel;
8.3 support the claimant, should he or she wish to formally lodge a claim for compensation; and
8.4 collect administrative information for identification of the claimant.

 

9. The Administrator must:
9.1 arrange for meetings of the Adjudication Panel and prepare the documents related to claims lodged since the previous meeting;
9.2 keep a record of the proceedings and outcome of each adjudication and award;
9.3 prepare the request for payment for the Director General to Authorise;
9.4 ensure that payment is made; and
9.5 provide feedback to the claimant.