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comment_58292

What is your acceptable temperature for blood bank room/work area?

What is your acceptable temperature for your reagent storage area (for blood bank, particularly ECHO reagents)?

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  • Malcolm Needs
    Malcolm Needs

    Auntie-D, you should have immediately challenged that non-conformance - and reported the inspector.   The inspector is allowed to ask if a person is doing CPD, BUT the content of a person's CPD folder

  • That's one way to do it! Unfortunately I guess the issue with ours is there aren't enough ducts into the lab, so they will have to do some major work to fix it. Meanwhile we're currently dealing with

  • David Saikin
    David Saikin

    We store everything in one ref - reagents and rbcs.  alarms are set for 2C vs 1C as most reagents are 2-8C for storage. CAP and FDA have no problems with this arrangement.

comment_58293

The acceptable operating environment temperature range for ProVue is 18C-28C.

For gel card storage it is 2C-25C.

Edited by Dansket

comment_58315

I'm a cola surveyor and their BB specialist.  You determine the acceptable range of your refrigerator as 1-6C but if you store reagents in the same frig as your blood products, then the range must be 2-6C in order to have a range that is acceptable to everything that is stored in the frig.

comment_58321

TEMP RANGE FOR ECHO REAGENTS IS 1-30 C. ROOM TEMP IS USUALLY CONSIDERED TO BE AROUND 22-26 c.

comment_58322

For us, acceptable room temp is 18-26C. Our antigen typing sera package inserts indicate room temp testing should be done at 23C +/- 3C, so this is why.

 

We have been lucky so far, our blood bank is crammed into a tiny room with inadequate air conditioning and temps routinely rise to 25C easily, and have gone as high as 26.4C. We just have to watch what we are testing at the time and be careful not to keep units out for any length of time, and hope that they can get us some more air.

comment_58325

Check your specs for your Echo analyzer.  My Tango has specs for room temp and humidity levels.  We started monitoring our humidity when we implemented it.

comment_58333

 We have been lucky so far, our blood bank is crammed into a tiny room with inadequate air conditioning and temps routinely rise to 25C easily, and have gone as high as 26.4C. We just have to watch what we are testing at the time and be careful not to keep units out for any length of time, and hope that they can get us some more air.

 

We managed to get ours to 32.4 on day of inspection (not on purpose guvnor!) and managed to get a major nonconformance for it. Within 2 weeks we had a spangly new air con unit...

 

 

I'm a cola surveyor and their BB specialist.  You determine the acceptable range of your refrigerator as 1-6C but if you store reagents in the same frig as your blood products, then the range must be 2-6C in order to have a range that is acceptable to everything that is stored in the frig.

 

You should not be storing reagents in the same fridge as blood products so this is irrelevant ;)

comment_58336

We managed to get ours to 32.4 on day of inspection (not on purpose guvnor!) and managed to get a major nonconformance for it. Within 2 weeks we had a spangly new air con unit...

 

That's one way to do it! Unfortunately I guess the issue with ours is there aren't enough ducts into the lab, so they will have to do some major work to fix it. Meanwhile we're currently dealing with construction as they build a fancy new consolidated ICU wing and add beds here and at our sister hospital and we've been asked to take on adding two blood bank-managed TEG analyzers. No idea where we are going to put them!

 

You should not be storing reagents in the same fridge as blood products so this is irrelevant ;)

 

Should not, or cannot? We store everything in one refrigerator at our sister hospital due to space issues. I'm just a lowly tech, is there a reg I don't know about referring to this? I understand it's ideal to keep them separated, but we've never been cited by CAP. Everything is on separate, labeled shelves.

comment_58337

We store everything in one ref - reagents and rbcs.  alarms are set for 2C vs 1C as most reagents are 2-8C for storage.

CAP and FDA have no problems with this arrangement.

comment_58338

Ah maybe it's because we're in the UK and they are more anal here... We even have to label fridges so that we store reagents above samples as the other way around isn't acceptable.

 

Our inspectors are hilarious. We last got inspected a couple of months ago and got a non conformance for someone not doing a reflective practice write up for a course they went on - the certificate of attendence wasn't enough as according to him 'you could have been asleep on the whole of the three days' *rolls eyes*. The inspector did however like the 'banter' between staff members and even commented on how the boss got dragged into it and it was refreshing to see - we have a lovely, and humourous, team :)

comment_58343

Auntie-D, you should have immediately challenged that non-conformance - and reported the inspector.

 

The inspector is allowed to ask if a person is doing CPD, BUT the content of a person's CPD folder/file is ABSOLUTELY private to the individual and the organisation who is running the CPD scheme (and now, of course, HCPC).  The inspector, whether they be from MHRA, CPA or any other organisation has NO right to demand to see the contents of the folder/file (although the individual can be requested to allow the inspector to see the contents of the folder/file, something I would NEVER allow).  However, even if your staff member did allow the inspector to see the contents of their CPD folder/file, and the inspector did not like what he or she saw, all he or she can do is give advice to write more (or any) reflective notes.  Under no circumstances can this be made a non-conformance against the laboratory.

 

Similarly, incidentally, the laboratory's performance in NEQAS exercises is also entirely private between the laboratory and NEQAS.  The inspector needs to know that you are doing the correct NEQAS exercises for your particular laboratory, but has NO right to actually see your results.  I've had some inspectors that are full of themselves DEMAND to see our NEQAS results, but when I have threatened to report them, they pretty soon withdraw their DEMAND!!!!!!!!!!

 

YOU HAVE GOT TO STAND UP TO THESE PEOPLE.

comment_58344

Would you be willing to translate a few acronyms for people like me who are confused?

comment_58346

CPD = Continuing Professional Development.

 

HCPC = Health and Care Professions Council (the people that state register us).

 

MHRA = Medicines and Healthcare products Regulatory Authority (one of our regulatory authorities - the one with the teeth!!!!!!!!!!!!).

 

CPA = Clinical Pathology Accreditation (another one of our regulatory authorities - the one that wishes it had teeth).

 

NEQAS = National External Quality Assessment Service - who send out exercises for us to perform.

comment_58347

Interesting. The US equivalent of NEQAS testing is a specific item to review during an inspection here.

comment_58348

Well, as it happens, if the inspector asks, rather than demands, I am quite happy to show him or her our NEQAS results, as we have nothing to hide, but they do not have the right to see them.

 

Similarly, I am quite happy to show them my own CPD folder/file, if they ask, rather than demand as, again, I have nothing to hide, but they do not have a right to see it, and I would never allow them to look at another member os staff's CPD folder/file, unless the staff member explicitly agrees, but, even then, not writing reflective notes is not a non-conformance.  It certainly is for the organisation running the scheme, and for the HCPC, but not for accrediting inspections.

comment_58356

Auntie-D, you should have immediately challenged that non-conformance - and reported the inspector.

 

... 

 

YOU HAVE GOT TO STAND UP TO THESE PEOPLE.

 

I have just read the report - 15 non-conformancies under the new ISO standards - how this compares to the rest of the UK, I have no idea... There wasn't any reference to sleeping, or in fact any CPD. It seems it may have been the inspector's sense of humour. We are a witty lab but you don't really expect the inspectors to join in ;)

 

They were EXTREMELY complimentary about the level of knowledge and the workign rapport that staff have - *feels all warm and fuzzy*

Edited by Auntie-D

comment_58362

Congratulations.

comment_58367

Definitely.

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