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  1. #1
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    Open Reporting Culture?

    Saddened to hear that a colleague who was in charge of a large multi-site dept had recently lost their job within a short time frame of placing multiple incident reports on unsafe staffing levels, as part of the process of building evidence for Capacity Planning.

    Our profession has lost another very experienced and talented transfusion scientist who was trying to do the right thing and highlight patient safety concerns, as is our professional responsibility to do, in a so called transparent and open reporting culture.

    Do some organisations think that that recommendations from The Francis Report & the Don Berwick report : “A promise to learn- a commitment to act” not apply to them?

    Drive out fear from an organisation-as fear is toxic to safety & improvement.

    The above statement was first described by W. Edwards Deming, over 70yrs ago- and obviously still being ignored.

    If anyone has similar information to share please do so on this forum, PM me or report confidentially to the UKTLC via NBTC/ NHSBT/ SHOT.

    Thank you

  2. #2
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    As I understand the situation Rashmi, it is even worse than you say. The colleague has lost their position, but another person, who wrote directly to the CEO on the same subject, has been told that, if they write to the CEO directly again, they will be sacked. In addition, one of the people appointed to "run" one of the blood transfusion laboratories is a Transfusion Practitioner with a nursing background. Now, there is nothing wrong with nurses (or Biomedical Scientists) being Transfusion Practitioners, but neither a nurse, without sufficient training and education, nor a Biomedical Scientist, without sufficient training and education, should be appointed to such a position, as it goes directly against the standards as expounded by UKTLC. There was talk that, in the USA, nurses would be able to run a blood transfusion laboratory (causing outrage amongst the laboratory technicians there), but the "powers that be" have rejected the idea. It seems strange that, whilst such an idea is being rejected in the USA, certain hospitals here are appointing whomsoever they want, irrespective of published standards.

    As I understand it, none of the people appointed to be the lead Biomedical Scientists in any of the Trust's blood transfusion laboratories actually hold the qualifications sanctioned by the UKTLC standards (although it would appear that one may be able to demonstrate equivalence, but has yet to so do).

    There is much more to it than this, but, although this may sound like a rant by a Biomedical Scientists against either nurses or other more junior Biomedical Scientists from taking over, this is far from the case. This is yet another situation where the patient is being compromised for a bit of budget saving and a bit of face saving for the board.

  3. #3
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    Transfusion Guru, I too have spoken to colleagues who say Senior Pathology Managers are not supporting the : UK Transfusion Laboratory Collaborative Standards. So does this really mean they are not supporting the Blood Safety & Quality Regulations, as the standards can be mapped right across to BSQR and EU GMP ?

    BSQR Regulation Section 9. (1) (a): The person responsible for the management of a hospital blood bank shall— ensure that personnel directly involved in the testing, storage and distribution of human blood and blood components for the hospital blood bank are qualified to perform those and are provided with timely, relevant and regularly updated training;

    EU GMP 2.1:The manufacturer should have an adequate number of personnel with the necessary qualifications and practical experience. Senior management should determine and provide adequate and appropriate resources (human, financial, materials, facilities and equipment) to implement and maintain the quality management system and continually improve its effectiveness...........

    The UKTLC Standard describes in greater detail the actual qualifications required, in a similar way that the BCSH guidelines for Compatibility testing, describes the laboratory testing requirements, ( and also cross-references the UKTLC Standards). Everything is interconnected.

    If staff without the necessary training and knowledge requirements are running labs, then surely this is in breach of the regulations, and possibly a problem for the CEO- who is deemed to be the "Responsible Person" for the blood bank ?
    Last edited by Rashmi; 16th Dec 2016 at 11:46 AM. Reason: correction formatting

  4. #4
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    I am absolutely certain that this should be a big worry for the CEO - especially if, God forbid, anything does go wrong. This type of thing has always been a bit of a problem. I recently read a quote from a paper by Rufus Stetson, who was the very much less famous co-author with Philip Levine in their seminal paper of 1939 on anti-D, where he was railing against the way blood group and blood transfusion testing was performed with an "indifferent attitude on the part of those in authority in regulating this most important work to the care of inexperienced and poorly trained persons." (Stetson RE. Causes and prevention of posttransfusion reactions. Surg Clin North Am 1933; 13: 319-345), although I have to say that I have not read the paper myself.

    It is slightly different now, in that the regulators (MHRA, through BSQR and EU GMP, UKAS, through their standards on competency and UKTLC with their standards) have specified that such people should be experienced and properly trained, but that their regulations are being openly flaunted by individuals with ultimate responsibility in certain Trusts, such as this CEO. I have NO legal training whatsoever, but, if the worst did happen, and a patient died as the result of a laboratory error, to my mind, the CEO MAY be in danger of being charged with Corporate Manslaughter?

  5. #5
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    Unsure now how to proceed, as encouraging better incident reporting to help with lab Capacity Plans may backfire. Really down to the regulators to come up with a plan.

  6. #6
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    Is this encouragement made on the basis that more incident reporting will mean that the powers that be have to do something about it?

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