Haemovigilance

Haemovigilance information

Diligently measuring transfusion and donation outcomes

The Blood Services in South Africa participate in a formal haemovigilance program. Information is gathered from reports on adverse events associated with blood transfusion and blood donation. The data is analysed and the results are distributed through the annual haemovigilance report. Its aim is to enable the Blood Service and clinicians to improve blood transfusion and donation safety. Reporting adverse reactions is mandatory for the success of the program.

Look back programme

The Look Back Programme was initiated in 1985 by the Blood Services in South Africa. Its aim is to assess the incidence of transfusion-transmitted infection. There are two types of look back procedures i.e. recipient-triggered and donor-triggered. 

Recipient-triggered look back

The recipient-triggered Look Back is initiated by the clinician who reports that his/her patient has developed an infection, which may be transfusion-related. 

Definition
Recipient-triggered Look Back involves tracing and testing the donor(s) when the blood recipient develops an infection, which may be transfusion-related.

The process

  • The clinician reports the blood recipients test results to the Blood Service.
  • The donor(s) is contacted for testing and possible viral sequencing. Should the donor test reactive for the relevant virus/bacteria he/she is permanently resigned from donating.  
  • Blood products from the previous donation, which may be in stock, are recalled for further testing. It is not necessary to retrieve virally inactivated products. 
  • The Blood Service sends the completed investigation report to the clinician. 
  • The prescribing clinician is responsible for counselling and testing the recipient. (The Blood Service covers the cost of testing). 
  • The Look Back case is closed at the discretion of the CEO/Medical Director of the Blood Service after the traceable recipient(s) has been tested. If the recipient or the clinician does not respond after 24 months, the case may be closed.
  • All communication with the clinician and the recipient(s) is recorded for medico-legal purposes. The reports and records are stored indefinitely. 
  • Look Back statistics are reported in the annual National Haemovigilance Report for Blood Services in SA.

 

Donor-triggered look back

Definition
Donor-triggered Look Back involves tracing and testing the blood recipient who has received blood from a previously screened negative donor who has subsequently tested positive for HIV, Hepatitis B or Hepatitis C.

The process

  • When a donor who has previously screened negative but has subsequently tested positive for HIV, Hepatitis B or Hepatitis C, he/she is counselled and permanently resigned from donating.
  • All blood products from the index (positive) donation are quarantined and destroyed. 
  • Archived samples from the index and previous donation are retrieved for possible viral sequencing. 
  • Blood products from the previous donation which may be in stock are recalled for further testing. It is not necessary to retrieve virally inactivated products. For a HIV Look Back case the most recent negative unit(s) of blood/blood product(s) is traced irrespective of the time period that has elapsed between the seronegative and seropositive donation. For Hepatitis B and Hepatitis C cases respectively, the most recent negative unit(s) of blood/blood product(s) donated up to 6 and 12 months prior to the seropositive donation is traced.
  • The blood recipient(s) from the previous negative donation is identified and traced, for testing. The Blood Service notifies the clinician of the Look Back by letter and sends him/her a consent form for testing and a letter for the recipient.
  • The prescribing clinician is responsible for tracing, counselling, testing and managing the recipient. If the recipient tests positive, viral sequencing should be performed to determine the source of the infection. (The Blood Service covers the cost of testing). The clinician informs the Blood Service of the test results and follow-up of the recipient.
  • The recipient who tests negative for the virus more than 6 months post transfusion is unlikely to have been infected and does not require further testing. The recipient who tests negative for the virus less than 6 months post transfusion may be in the window period and should be retested after 6 months has elapsed. 
  • The look back case is closed at the discretion of the CEO/Medical Director of the Blood Service, after the traceable recipient(s) has been tested. If the recipient or the clinician does not respond after 24 months, the case may be closed.
  • All communication with the clinician and the recipient(s) is recorded for medico-legal purposes. The reports and records are stored indefinitely. 
  • Look back statistics are reported in the annual National Haemovigilance Report for Blood Services in SA.