bmsjbatt

Sorry Rashmi, for late response been out of the loop for a while, dsicussions with colleagues who have been inspected is that the methodology is closer to an MHRA style inspection of show me, and following the rabbit down the hole approach, rather than the previous audit checklist approach.

Oh how I wish I had version5, still stuck with clunky old version 4 for me

Regulators in the UK expect clear competencies on ANYONE working in the bloodbank. If they are "in training" they MUST be supervised by someone with current competency in the tasks being completed. This includes Locums, part-timers and students. In fact they have reccommended that part-timers on shift are specifically rota'd onto days for a specific period of time in blood bank annually to ensure their competencies are still valid. we also have to have a plan of reassessing competency on any staff member who has been out of the department on sickness / maternity leave etc for more than 3 months.

I would recommend that as long as you state what is required in the competency assesor to enable them to carry out assessments. then you can allow for more than one assessor and they assess each other. This seems to be the way the UK regulatory / accreditation agencies are wanting us to go. We state what we consider to be our requirement and then stick to it. e.g. must have qualification x, y and z and have carried out work as senior member of staff in discipline "a" for 4 years minimum and attended training course on "subject" etc

Malcolm, It appears to be equivalent to the IBMS Specialist / expert practice diplomas. Certainly post graduate level but below PhD. as many of the advertised courses can award credits to MSc degrees.

Why are you sending all of your pipettes away at the same time?? I would at suggest that you first send away half, leaving yourself with a suitable selection to continue with operating your systems, then 6 months later send the others off, that way you are never without any suitably calibrated, serviced pipettes.

Try something using the following layout (understands is for the SOP / process) [TABLE=width: 644] [TR] [TD] [/TD] [TD]UNDERSTANDS[/TD] [TD] [/TD] [TD] [/TD] [TD]SHOWN TASK[/TD] [TD] [/TD] [TD] [/TD] [TD]COMPETENT[/TD] [TD] [/TD] [/TR] [TR] [TD] Basic theory given and understood[/TD] [TD] [/TD] [TD] [/TD] [TD] Task demonstrated and explained[/TD] [TD] [/TD] [TD] [/TD] [TD] [/TD] [TD=colspan: 2]Agreed Competent[/TD] [/TR] [TR] [TD]Date[/TD] [TD]Trainee[/TD] [TD]Trainer[/TD] [TD]Date[/TD] [TD]Trainee[/TD] [TD]Trainer[/TD] [TD]Date[/TD] [TD]Trainee[/TD] [TD]Trainer[/TD] [/TR] [/TABLE]

Bump. We have recently received notice regarding IT systems, and had to supply details of trust / IT technical agreement, mainly dealing with disater recovery and ability to access legacy systems / archives, but also with regard to IT failing to supply the department with change control notifications prior to carrying out a programme of hardware refresh. Jo

Hi Rashmi, Recent Inspection, we were commended on the groups we have been using so far, but were also recommended to clearly separate the incidents identified internally and those identified external to the department. our groups so far are. CodeTrend analysis code 2010 A Personnel B Reagent C Equipment D Training- lab staff E Process/ Failure to follow Trust Guidelines F Communication G Concessionary Release / deviation H DelayIRecall J Wrong patient bled/ details written on K Training- porters/ nurses/ drs/ drivers L Traceability M Hospital patient numbering problems N SLA Hospital O NBS errors P Product Q Winpath R Complaints S Cold Chain T Inappropriate product issued/transfused U None assigned/ not applicable V Clerical Errors Hope these help. Jo

Indeed, I sympathise with you on this, however do you not get any support from clinical director / Exec team, as they are ultimately responsible for MHRA failures and must answer to the DOH if things are not done properly? so maybe you need them to "order" your IT bods to do things properly and not in a half-arsed way. Not saying this is the solution to all your problems, but if a sideways / bottom - up approach isn't working for you, maybe you need a top down approach. best wishes Jo

Wow, this is great, Thanks for this I am now sitting highlighting the bits I want to watch.

Are your PATH IT people Pathology staff with an IT interest? or IT people working in the PATH environment, if they are the latter start talking to them about ITIL best practice as much of the BSQR stuff relating to IT validation is based on ITIL service managment acceptance criteria. and they should be working to ITIL standards as it is an NHS preferred way of operating.

Ok then, Keep Blood Bank Blue, make Haem red (as they more often deal with whole blood) and Chemistry Yellow (as they more often deal with Serum ) then Micro could be Green (more like the colour of some colonies !!!) and Cell Path Purple like the combined colour of the H&E stain. Simple!! ;-)

Hi Rashmi, What reference did they give to accompany the Non conf?? If they didn't give a reference I would argue the non conf. or ask them to reference the regulation they are using to support the N/C. I would agree that the Format of the worksheet can be document controlled and be part of your usual document review cycle and link it's review to that of the SOP that it is mentioned in, but the worksheet itself cannot be controlled as it is a working document, provided that each action / entry can have an appropriate date and signature attached to it (could always use the track changes function in excel?) For our QI worksheet I have shamelessly stolen and modified your spreadsheet and it was accepted as a suitable worksheet by our MHRA inspector when we sent it to him to close a post inspection N/C of us not having an overall monitoring tool. Hope this clears things up a bit:)

I'll be interested to see any results too, but I suspect that there is no easy answer and that this is just down to common sense. the proof will be in an MHRA response I suspect. regards Jo