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28th Sep 2017, 10:55 AM
#1
MHRA report for National Blood Transfusion Committee September 2017
Please find attached the MHRA report recently presented to the NBTC
MHRA Report for National Blood Transfusion Committee.pdf
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15th Nov 2017, 10:29 PM
#2
Chris you state 52% of human errors are procedures not followed correctly or steps omitted..this is interesting as ithe proceedures are correct but for some reason not followed properly. It would be interesting to see what processes were being carried out to see why this happens and is there a pattern wit particular areas.
is it issues with the way the documentation is written and so difficult to follow?
Are the staff are not referring to them when they should?
Do they know what to do but aRer they cutting corners to get things done quickly?
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16th Nov 2017, 12:33 PM
#3
Hi Anna
You raise some key discussion points. My assessment is based on the information in the report and any information I get in addition from discussion with the reporter and additional information added as Footnotes. My assessment is a)subjective and b) limited to the information I have been given.
What I try and do with the information is to dig deeper than settling with "procedural" errors - either wrong procedures followed or steps omitted (e.g. not investigating a positive screen), or correct procedures followed but incorrect decisions made (e.g. samples checked on receipt but discrepancies not noticed).
This is why I ask you all those "tedious" questions!
One-off errors are unlikely be related to training or education of a member of staff, as they can demonstrate they know what to do and do it correctly regularly, but the effectiveness of training received or the adequacy of training delivered might be uncovered if the same mistake is made by a number of staff, or constantly by an individual. These would be categorised differently.
If they were rushing or cutting corners this may be related to staffing and workload problems then that also would be categorised accordingly. What I have to try and figure out though, is whether they are genuinely related to those factors, or whether the member of staff is rushing or cutting corners unnecessarily. Everyone gets busy from time to time, but that still is no excuse for cutting corners and rushing and the error might be addressed by better prioritisation by the individual or adjusting workflow and work patterns to address bottlenecks in the lab.
Similarly, process and documentation factors might also be involved. If the process hasn't been designed correctly, or the SOP written to ensure the process is carried out effectively, this can be rooted out and reports categorised if this is the case. Reporters should question, "Has this process been designed to ensure a consistent and safe outcome?" "Has the SOP been written, giving clear instructions, in a step-by-step logical flow?"
What I have seen, after some further questioning, is that some processes are being expected to be completed without there being an established process, leading to individuals performing the task differently. Likewise, I've seen examples where written procedures are not SOPs but protocols, guidance or policy documents. What I mean here is they tell the member of staff what needs to be achieved or what "must" happen, without detailing the steps to get to that point. I can always relate to an example I give of making a cup of tea. You could write a procedure that states you need to make a cup of tea, but unless your SOP states you need to get a cup, fill a kettle, boil it, add a tea bag to the cup, fill the cup with boiling water, wait 5 minutes, remove the tea bag, add 5mls of milk for strong tea or 20 mls of milk for milky tea, no sugar, one sugar or two sugars for unsweetened, medium sweet or sweet tea, you may end up with someone adding milk before the water and ending up with something horrible. You mustn't assume that without a robust process, a defined procedure and proper training that you will get a consistently perfect cup of tea. Don't be worried about long documents - you need to have them for training and to refer to if you are unclear. They are not going to clutter up the lab space if someone fully understand the process as they will be on the shelf for reference. A silly example I know, but it gets the point across I hope.
Therefore, I try to help and encourage reporters to dig deeper to find out why members of staff make slips or have lapses that result in "procedural" errors and only categorise if there is no evidence it can be categorised another way.
Many of the procedural errors might be re-categorised with further investigation or more information, but without it, I cannot make assumptions they are down to other aspects of the QMS.
However, this shows that prevention of errors is multi-factorial and depends on lab management addressing Quality System errors at source and individuals taking responsibility for their own actions.
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