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20th Dec 2018, 01:28 AM
#1
Delta check against migrated LIMS data
I am trying to gather info for future LIMS changes and recently a colleague mentioned that while their Grouping data was migrated to the new LIMS, this was a Read-Only copy, therefore the delta checking function wouldn’t work against this data ( ie wouldn’t alert if the group of a new sample was discrepant).
The impact of this set up would be:
1) all requests for blood would have to be serologically cross-matched, as EI criteria not met as only one recognised group on LIMS (until a second sample tested).
2) increased cross-matching for at least a few months- is this considered as part of resourcing- 24/7 workload ?
3) process for authorising all G&S tests would have to change- with a manual check against the historical read-only data- again for what length of time would this continue?
Considering the number of wrong blood in tubes that are recorded by SHOT and detected by the LIMS delta check rules, this active automated checking against the sample historical group is a critical process step during authorisation. If this is now having to be performed manually -will also affect sample TATs.
I’m sure there are colleagues out there that have already changed LIMS- please advise if some systems are capable of delta checking against the migrated data, or if the above is routine.
Many thanks!
Last edited by Rashmi; 21st Dec 2018 at 11:58 PM.
Reason: omitted some info
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20th Dec 2018, 12:59 PM
#2
[QUOTE=Rashmi;5616]I am trying to gather info for future LIMS changes and recently a colleague mentioned that while their Grouping data was migrated to the new LIMS, this was a Read-Only copy, therefore the delta checking function wouldn’t work against this data ( ie wouldn’t alert if the group of a new sample was discrepant).
The impact of this set up would be:
1) all requests for blood would have to be serologically cross-matched, as EI criteria not met as only one recognised group on LIMS (until a second sample tested).
2) increased cross-matching for at least a few months- is this considered as part of resourcing- 24/7 workload ?
3) process for authorising all G&S tests would have to change- with a manual check against the historical read-only data- again for what length of time would this continue?
Considering the number of wrong blood in tubes that are recorded by SHOT and detected by the LIMS delta check rules, actively checking the history of every sample during authorisation would additionally affect sample TATs.
I’m sure there are colleagues out there that have already changed LIMS- please advise if some systems are capable of delta checking against the migrated data, or if the above is routine.
Many thanks!
Hi Can you please provide me with more details on this via E Mail michael.dawe@mhra.gov.uk. This issue should have been captured within the User Requirement Spec (URS) where a site should state that migrated data is essential in selecting patients for EI and to identify WBIT etc, as stated in the previous post, and therefore a delta check was an essential requirement.
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9th Jan 2019, 10:29 PM
#3
Having recently discussed UK-wide IT issues at a meeting, it’s apparent that LIMS are being selected at a few labs with very little involvement of BT Staff. Additionally, the amount of work to produce a good URS that would cover, at the minimum the basic requirements (and would capture issues as the above example), takes time to produce – there must be good templates around that can be shared across our community?
On a separate note, does anyone know of LIMS being hosted on the cloud? I have received conflicting information on this being reality, or wishful thinking. If cloud-based, are there any specific points that should be addressed if going this route -I would have thought security and robustness on the cloud would be very good , but as I know very little about LIMS infrastructure stuff, this would be a good place to learn.
Any advice/ sharing docs/ info would be much appreciated.
Many thanks!
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9th Jan 2019, 10:44 PM
#4
The bsh IT specifications are a good starting point for a urs as well as Gamp 5 and mhra data integrity guidance.
There are IT systems that delta check migrated historical groups against current groups
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10th Jan 2019, 11:54 PM
#5
Thanks for the info EClarke, there are many documents out there that are very useful- but anything we can do to help others with producing the URS and not having to wade through so much information would really help.
So, continuing on the topic of data migration of blood groups, does anyone know which blood group in the patients file is usually migrated over to the new LIMS (is this written anywhere)?
1. All the historical group results for the patient?
2. The last tested result only?
3. The ‘cardinal’ group ( the group selected as being the main blood group for the patient as there may be different ones on file eg BMT patients)?
Also, of points 2 and 3 which wouldbe used for the delta check when a new sample is tested?
Sorry for all the questions- but I need to understand the process and there isn't anyone else to discuss these niggling little issues with. With a couple of years of planning- might get it right when it happens!
Would be good to hear from others on any issues you have had and if there have been any related SHOT/ SABRE reports.
bw
Last edited by Rashmi; 11th Jan 2019 at 12:03 AM.
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16th Jan 2019, 11:39 PM
#6
[QUOTE=Rashmi;5640]
[On a separate note, does anyone know of LIMS being hosted on the cloud? I have received conflicting information on this being reality, or wishful thinking. If cloud-based, are there any specific points that should be addressed if going this route -I would have thought security and robustness on the cloud would be very good , but as I know very little about LIMS infrastructure stuff, this would be a good place to learn]
Further to the above question on cloud-hosting, I now have 2:1 opinions against this being reality for a LIMS, due to the risks of patient data being available across thousands of servers around the world. Local virtualised servers apparently being a better option. Perhaps I'll just stick to the transfusion software issues Though if anyone has other views/ information- I would be very interested.
bw
Last edited by Rashmi; 16th Jan 2019 at 11:44 PM.
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