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.

would it be correct to assume that ALL IT systems that affect the blood bank should have similar access controls, post service checks, disaster recoverability checks etc. This would include any document control systems and most importantly the hospital system where specific 'work areas' store forms, reports, inspection reports, BCR's documents??
Also would this include DATIX?

We have a central monitoring system which monitors all critical temperatures in the laboratory (incl BB). This includes monitoring room air in the BB lab (where RT reagents are stored. This is required by our regulators (to fit ISO15189 and EU and Irish Bloodbank regulations). It is set to alarm if within 0.5 degrees of the critical limits and phones us as well. Can then get in on web access to see what is going on if out of hours. Works well. The probe is placed in ice and then hot water to test that function and is calibrated yearly (at time of preventative maintenance).
Cheers
Eoin

Can't help you there ksmith, as we do all of our monitoring with a min-max thermometer read once or twice a day (not counting weekends and Public Holidays, but, believe me R1R2, if these readings go outside the recommended temperature range by even 0.5 of a degree, our Quality Department requires full validation of ALL of the remaining reagents kept at "room temperature" - sorry - bold, italics and underline stuck again!!!!!!!!!!!!!!!!!!!!!!

We use Q-Pulse Ver 5.7. I agree with Malcolm. It is great from a manager's perspective. A bit painful to set up, but once up and running your work can be set to flag for the coming week / month or whatever tie you like. I am the administrator in the hospital for it and it can be tweaked to suit you (can set up templates). It takes the backbreak out of ver updating, approval and distribution and only one emergency copy of SOPs need to be kept - the rest is available electronically at all workstations wherever there is a PC. SOP review dates can also be set. It also has Audit, Customer, Training, CAPA, People (staff records), Suppliers, Assets and administration modules on it as well.
I personally love it. It has stopped my life becoming hell and has saved a number of trees already.
Cheers
Eoin

agree with both of you. Issuing is the last thing we release our techs. on.

I agree with Malcolm. We do a final check of pretransfusion testing and transfusion orders at the time of issue as a final barrier to mistransfusion, if someone wasn't trained and competency assessed on a number of areas they wouldn't be able to issue blood products. If someone only rarely logged in donor units, I wouldn't trust them not to make a mistake - we see enough simple errors as it is. As far as logging in specimens, we don't even let the specimen processors from the stat lab do that. Maybe we're just paranoid, but I like paranoid.

I wouldn't let ANYONE work in my lab without a full competency check.
 
I would also not expect anyone to allow me to work in their lab without me having to undergo a FULL competency check.
 
Every lab is different.