14th Dec 2016, 09:37 PM
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.
15th Dec 2016, 07:55 PM
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.
16th Dec 2016, 10:42 AM
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 10:46 AM.
Reason: correction formatting
16th Dec 2016, 11:33 AM
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?
16th Dec 2016, 08:13 PM
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.
17th Dec 2016, 09:38 AM
Is this encouragement made on the basis that more incident reporting will mean that the powers that be have to do something about it?
17th Dec 2016, 01:56 PM
Partly- the main purpose being to correct all errors and build a picture/ trend of what is happening in the lab for further actions needed and to support any business cases for staff/ equipment resourcing. It is well known that an organisation with a good reporting culture not only reports serious patient safety serious incidents but many low level, no harm events, and is trying to continuously learn and improve, and working towards creating a Just Culture, where ultimately everyone wins.
Correcting these problems properly also releases time ( which we all need more of!) to do the rest of the job, rather than constantly fire-fighting.
Last edited by Rashmi; 17th Dec 2016 at 01:58 PM.
21st Dec 2016, 01:58 PM
Perhaps consider producing another DoH, Health Service Circular as per HSC 1998, 2002 and 2007 on Better Blood Transfusion. Resourcing for these was more successful as the documents were directed at Trust boards and came down to Pathology Managers and HTCs for review and accountability to implement:
Suggestions to include:
- Transfusion laboratory managers must report concerns with staffing levels and skill mix via a formal process to the Trust (via incident reporting/ HTC/ PBM committees).
- Staff must be encouraged to report minor as well as serious transfusion related incidents and events that may occur in both the clinical and laboratory areas, without censure.
- As the Transfusion lab provides both a diagnostic and therapeutic service, in an increasingly changing environment, the training needs are more stringent, and this should be reflected in staffing requirements .
- The laboratory must work towards meeting professional educational, training and knowledge requirements as described in UKTLC standards and all other BCSH guidelines, as well as maintaining compliance with the BSQR, EU GMP and ISO 15189.
Would really appreciate ideas from others about this. Do you think it is achievable/ realistic etc??
Last edited by Rashmi; 21st Dec 2016 at 01:59 PM.
11th Jan 2017, 09:24 AM
The MHRA promote an open reporting culture as an essential pillar of an effective quality system and would be very concerned if staff were penalised for bringing issues to the fore.
If such events arise, can I suggest you advise via the NHS Whistle blowers email (firstname.lastname@example.org) in the first instance. If that fails you could report to the MHRA as a whistle blower by emailing MHRA customer services (email@example.com) and providing details. Whistle Blower communications with the MHRA are treated in complete confidentiality.
11th Jan 2017, 12:46 PM
Thank you for your reply.
Having discussed this with folks, the opinion is that staff still feel unsafe and lack confidence to whistle blow, regardless of some excellent hospital policies around, and the presumed confidentiality of the process,and any formal means of reporting concerns. It is very easy to trace back to the whistle blower or to assume (correctly or not) the source, and for repercussions on the blood bank manager and team.
Whistle blowing is also a very reactive process rather than building this within the QMS framework.