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Thread: A few reporting hints and tips

  1. #1

    A few reporting hints and tips

    Following a number of recent discussions with reporters, and assessing the reports on SABRE, Mike and I were conscious that perhaps some reporters were overcomplicating the SABRE reporting process, overlooking the regulatory requirement of reporting. Although focusing on reporting under BSQR, the points below are also pertinent to SHOT reporting as well.

    A few points and hint/tips to consider

    Reporting an SAE/ SAR must be completed “as soon as known”. In practice, Notification within 48 hours of the incident occurring, or being brought to the attention of the investigator/reporter. The Confirmation report, with root cause and CAPA should be made within 1 month, if possible.

    You need not perform a full-blown RCA investigation for the less serious or low-frequency errors. A lot of time and resource can be taken up by reporting, investigating and resolving these errors. The important thing is quickly identifying the RC and implementing appropriate CAPA to correct and solve the error. You don’t have to follow a convoluted investigation process simply to demonstrate you have followed a convoluted investigation process. For example, should you decide a one-off transposition of labels, or missed discrepancies between sample labelling and LIMS is serious, then by all means report it, but keep the investigation simple. Recognition that a slip or lapse occurred due to some kind of distraction may well be the RC. A simple discussion bringing it to the attention of the reporter, verification the correct process is understood may well be all that’s required to report in that particular case. In this case, it may not be appropriate to retrain or get the member of staff to formally reflect and document it.

    There may be times when the outcome or potential outcome might result in serious harm to a patient, or a serious impact to service delivery, and then it might be appropriate for a larger scale investigation, using as many RC identifying tools as are necessary. Similarly, if you are experiencing a pattern or trend of similar reports, then it may be necessary also to do a more in depth investigation. E.g should multiple labelling errors or incorrectly accepted samples occur, then it may be necessary to step up the investigation, assess workload, staffing levels, etc or identify issues with a member of staff that require formal reflection and/or retraining
    When it comes to submitting your Confirmation report, do not delay putting it on SABRE because your process insists that the report is reviewed and approved by the HTT or Risk Management Board. These unnecessary additional steps are interfering with your regulatory requirements as reporters. SABRE isn’t there to reflect your local incident reporting process. You do not have to submit to SABRE only after your QMS has demonstrated the CAPA to have worked and have been approved by numerous Trust committees. Your responsibility is to report your investigation and corrective measures to the Competent Authority, as soon as known. This is so we can assess the appropriateness of the investigation and feedback if required in good time. We can’t do that if your investigation is delayed by a process of getting the report reviewed in a meeting in 2-3 months’ time.

    If, as a result of your internal meetings the CAPA has changed, you can update the report with changes as a Footnote. This is acceptable.

    There are always times when reporting is delayed. This is okay. But tell us the progress of the report and/or the reason for the delay on a Footnote.


    The following table can be used as a guide to reporting timelines






    Finally, when it comes to your investigation and your report, it must be

    As simple as possible but as detailed as necessary.
    Attached Images Attached Images
    Last edited by Chris Robbie; 2nd Nov 2018 at 01:39 PM.

  2. #2
    For a larger version of the table click the attached thumbnail icon above nearest the right hand side!

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