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Actions within the SPEAR reporting tool

Drafting a report

  • Step 1: Login to the SPEAR online reporting tool with your user name and password by using the steps listed above. Don't have a user name and password yet? Please see below at the FAQ "How do I register as a SPEAR reporter?" 
  • Step 2: Choose the role of reporter with the correct organisation when you login to draft reports
  • Step 3: Click Create new report at the top of the page under Report list to start a new draft 

  • Step 4: Start your new draft report by entering the Type of report first. Once you've selected the correct type of report, the rest of the tabs will become filled with questions based on the type of report you selected.

    Note
    titleChange the report type

    You can always change the Type of report by going back to the first tab (Type of report). If you change the type of report selected, different follow-up questions might appear. Answers previously given can be automatically erased if they no longer are part of the question list belonging to the new Type of report you selected. 

Adding an attachment to your report

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Expand
titleDefinition of adverse events

The WMDA follows the EU definitions of a serious adverse event or reaction: 

Definition serious adverse reaction (SAR):

An unintended response, including a communicable disease,  in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity.

Definition serious adverse event (SAE):

Any untoward occurrence associated with the procurement, storage and distrubution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-greatening, disabling or incapacitating conditions for donors or patients or which might result in, or prolong, hospitalisation or morbidity.

Criteria for serious adverse event (SAE):

  • The event (could have) led to inappropriate use of tissues or cells 
  • The event (could have) resulted in loss of the complete or significant quantity of irreplaceable cells 
  • The event (could have ) led to a serious adverse reaction (grade 2, 3 or 4)
  • The event (could have) led to misidentification or an unintended switch of cells
  • The event (could have) led to (an unforeseen) transmission of disease from donor to recipient
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titleRole definitions and process flow

Donor, transplant or collection centres are affiliated with donor registries have the possibility to create reports and submit them to the reporting organisation/donor registry. The further handling of the report will go via the donor registry. The donor registry can approve and submit reports from submitting organisations as well as their own incident reports.

When submitted, all reports are available to the WMDA office and the SPEAR Committee. The WMDA office team for SPEAR reporting consists of a medical advisor and a project coordinator. The medical advisor reviews all reported incidents at least once a week and checks for rapid alerts. If necessary, the medical advisor can request the reporting organization for additional information. If the report is approved by the medical advisor, it will be turned over to the SPEAR Committee. 


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