jayjay

I think you will find that many questions are raised over IT issues as this appears to be an area which is not well managed as it often involves more that the transfusion laboratory

The other point I would make is that it may not be necessary to perform serological investigations on all ??transfusion reactions reported by the clinical area. It may be necessary to review the information collected at the initial phone call to the lab, follow a planned protocol, and then perhaps involving the TP make a judgemnet on whether there is a need to investigate further

I think you are all trying to read too much into all os this and some common sense is required!! Yes SAE's may go up as people realise and recognise what these are. A good Quality system shoull see a decrease in these over time proving that the CAPA is effective. It is the tracking and trending that is the really important issue. Repeat, same type, SAEs is fairly obvious that the PAs are ineffective that the root cause has not been determined and managed Thats my view anyway Perhaps I am too simplistic Joan

I think the clue is Serious Adverse Reactions and it is up to you as the HTT to define what is serious

You can arrange for the BCSH site to email you when a new guideline is published

Again I would say keep it simple. If DATIX is your primary incident management system then it will need to be treated the same as the LIMS in terms of validation, upgrades etc. As most transfusion labs do not have control over DATIX and other staff can alter information I would not use as the primary system. Yes clinical incidents should be reported to DATIX and others if you so desire but you will still need to keep records for 15 years so think carefully

It would be expected that each organisation will determine their minimum staffing level and skill mix. Trying to work this out as a generic option is just not possible. As well as taking into account automation you would also need to consider: - work patterns - emergency v elective - % EI - type of patient eg high % thals etc - 24/7 work patterns and the list goes on

3.1 as meaning AFC Band 7 and above. Some Blood bank managers/ Lead BMS staff are banded as 7 , with others at 8 The collaborative document refers to healthcare scientists level 7 NOT AfC band 7

Thanks Malcolm, there are many variables in this. Do other transfusion Lab managers also take fiull responsibility for haemovigilance reporting or is this generally devolved to the transfusion practitioners? In my opinion no one person should take full responsibility for haemovigilance reporting this should be an HTT responsibility involving the transfusion lab manager, the TP, the consultant Haematologist and should be "signed off" by the Quality Manager or their nominated person. To me that then becomes Incident Management in its fullest sense

Merging of patient records on the LIMS, whilst subject to procedure was not effectively controlled as evidenced by: 1.There was no process in place to enable an unmerge to be performed. 2.Evidence was observed where a patient had been merged on the system without appropriate approval of suitably qualified BT staff. So who is undertaking the merges? Are they lab staff or PAS administrators. Who ever it is they should be working to a policy/procedure which the TLM or QM has contributed to and authorised and be trained to the policy Merges at the PAS level (referring to medical records dept)were completed with procedures that: 1.Were out of date in that there was no evidence of formal periodic review since its issue in XXXX In addition there was an emboldened note on the procedure that stated the procedure was not to be used after the review date of XXXX 2.The procedure lacked sufficient detail to enable a merger to be safely employed. 3.There was no involvement of suitably qualified Blood Transfusion staff in PAS merges where the patients had Blood Transfusion or testing history. 4.There was no unmerging procedure available to enable the records to be separated in future should this be required. Again the procedures should be part of the transfusion document control and written with input from transfusion staff. The policy should clearly state how many identifiers would be used to merge and this perhaps should include group were available. Perhaps they should send a request from PAS administrators to BT about whether patients can be merged or not as if you need to unmerge you may have to print out the details of both patients and all testing and components issued etc

Who is your LIMS provider? Dialling in as a very difficult area to control. Any changes/upgrades should come with the full paper work, be validated in the training database before being uploaded into the live database. Ideal world scenario!!

you develop a simple document change/modification form for staff to suggest changes which can then be quickly reviewed, assessed and approved, if appropriate, at any point during the lifecycle of that document This seems very reasonable but is not saying you need to run your formal change control but developing a change/modification form which would be part of your document control system

I would suggest you have a look at the times you process the majority of your samples and select times prior to this to run a set of controls then you will not then need to rerun lots of samples if you get a failure

.7.16 Is there a documented system in place to describe change control? (This should demonstrate assessment and management of the impact of any procedural or equipment changes on the validation status of existing processes, and to ensure that training and documentation is available prior to the implementation of a change). YES / NO So have you a policy and procedure which describes how to manage change control? If so the answer is yes? 3.7.17 Does this system control changes to: Documentation (SOPs and records)? In your change control procedure do you identify all documents which need updating or new documents which you will be required to write I agree with Malcolm staff should not be able to change documents without authorisation. This is what a good document control system would not allow.

Document control does not have to be managed by an electronic system. In our place we use a paper based system. Document control is all about ensuring documents are regularly reviewed, identifying who has paper copies, recalling these when a newer version is produced, version control of all documents, keeping a brief history of changes etc. All this can be done on a spreadsheet or database. So if we make minor changes ito a document which is version 1.0 it then becomes version 1.1 and will need to be read by all but if there are major changes it will be version 2.0 and will require training for all. We document control all forms and have a document register of these Joan

Well in my simple mind whenever you make a change to a document this must be controlled ie document control. If you are making a significant change to a SOP/procedure/policy it is likely that you will have raised the process/system change under your formal change control process in which you will identify the documents that need changing BUT you will still need to manage this change to the documents within your document control system. Does this make sense

Is there some confusion between Change Control and Document Control?

The question is what do you do with test results prior to the control failure? Do you re-run all from the previous control which was correct? Do you check all results to see what % had a historical result and document that? Interesting dilemma!!!

Below is a Question to MHRA and their answer, may help There appears to be some confusion about the appropriate method to use in order to record refrigerator temperature. Whether core temp or air temp is better and if core temp is monitored at all, what volume of fluid should be used for the sensor to be placed into. What does the MHRA recommend and why? Response For routine monitoring the MHRA recommends that core probes with a representative volume (this will differ depending on whether the site handles primarily paediatric or adult units) are used. The reason core is recommended is that it gives a direct correlation to the actual condition within the components, if core probes are used then there should be no delay on the alarm and the alarms need to be set at 2 - 6ºC. Air probes can be used for routine monitoring but in this case the site has to demonstrate how this correlates to the component conditions especially where alarm delays are set and where the alarm limits do not directly correlate to the BSQR art four requirements e.g. 2 - 6ºC. Air probes can be problematic as they will show temperature fluctuations very quickly e.g. door openings and may lead to nuisance alarms. Air probes are however recommended for mapping

I am from the UK and have been told that the FDA requires temperature mapping to be performed over 20 days with a reading taken every 4 hours. Can anyone tell me if this is correct for the US? Joan

I would think non compliances in clinical audit should be fed into the Trusts risk register. Think it may be confusing to feed into lab QI unless there is something specific to labs Joan