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Thread: Manual Back-up systems

  1. #1

    Manual Back-up systems

    Dear All

    I'm asking on behalf of a SABRE reporter for ideas to solve the following.

    An SAE was reported where during the malware attack recently and the LIMS was offline a sample and form were received which matched and was processed manually and blood cross-matched and issued. It came to light when the LIMS was back up and running that there was a spelling mistake of the patient's name.

    The investigation showed that the reporter didn't have a manual back up procedure for checking samples with historical patient data.

    Discussion with one of the inspectors suggested that they would expect a manual back up procedure to be in place

    "We would indeed expect a manual back up process if there is a problem with a computer system so that the HBB activities can continue in a safe and effective manner. This back up system should be reviewed / tested at an appropriate frequency to make sure it will actually work and at the end of the computer failure a (local) deviation should be raised and any manual data generated added to the electronic system and a reconciliation done to ensure no data has been lost."

    Do other labs have manual sample acceptance procedures to cover these situations and if so, could you outline what that process is for the benefit of our colleague?

    Many thanks.

  2. #2
    Forum Member
    Join Date
    Nov 2016
    Hi Chris,

    Depends what you mean by a manual back-up system. Generally labs may keep paper records containing antibody details and phenotypes, irradiation requirements etc, but not a record of every patient together with their blood group. Do the inspectors expect labs to hold a separate database, such as an Excel file with all this info too?

    In the event of a cyber attack, this would also affect the hospital PAS - so it may not even be possible to check basic patient demographics. Issuing blood without a LIMS is a recognised high risk situation, and spelling mistakes will occur as these generally involve manual writing and recording of patient and component details. Having spoken to some lab staff, their labs will not issue any blood unless it is a life-threatening situation- but how realistic is this?

    Be good to have others involved in this discussion.


  3. #3
    Join Date
    Jun 2016
    For clarification I thought an inspector viewpoint would be helpful here.
    Should the LIMS not be available, the site should have a system downtime plan in place which would typically include the following:
    A formal procedure clearly explaining the process to follow.
    Manual recording forms for testing and issues with suitable independent checks on data entry and interpretations
    All component issues to be serologically cross matched
    A restriction on routine testing to ensure that sufficient resource is available to address the change in practice. Typical only urgent issues will be permitted.
    A means to transfer the data back into the LIMS once it is restored, found to be operating as expected and stable.
    The transcription of data to populate the LIMS with manually recorded data should have an independent, preferably blind entry, check to ensure the data is confirmed to be correct

    It would not be acceptable to issue components electronically if the LIMS was unavailable. The use of a periodically updated spreadsheet download would not be acceptable as it would not be contemporaneous with the system failure, and would be out of date.

    Should an error in the data entry subsequently determined (e.g. incorrectly spelled name), the database management process should be used to correct the file within the LIMS as would be used for linking and merging records.

    Hope this helps clear up any misunderstandings in the previous posts.

  4. #4
    that's useful ! thanks!

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