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RR1

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What are folks thoughts regarding the blood transfusion department having a separate Quality Manual from the rest of Pathology?

When searching through the internet and looking at general Path Q. manuals, the transfusion sections are either non-existent (merged with Haem) or just a few lines with barely anything about the BSQR in them and purely written to appease CPA, which is important, but nothing really in them about patient safety etc. The Quality Policies also seem to be rather 'flaffy'.

Theoretically the Q.S should be one system to enable integration, but is this realistic at the moment, unless of course if the rest of your Path depts follow all same GMP criteria to the same depth as for transfusion labs?

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I agree with you that the Blood Bank should have a separate Quality Manual; not least, as you say yourself, because many of the other Departments only pay lip-service to GMP. At the very least, there should be a separate "chapter" in the QM devoted to BT, because it is the only Pathology Department that actually gives out a product; and a product that can kill.

Within the NHSBT, there is an over arching Quality Manual, but each section and sub-section (e.g. Specialist Services and, within that, Red Cell Immunohaematology) has their own QM; and this works extremely well (and CPA love it).

I'm now going for a lie down. Agreeing with you Rashmi has made me feel quite faint!!!!!!!!!!!!!

:D:D:D:D:D

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Thanks Malcolm, could be you're in a better mood because it's nearly Christmas???

I like the idea of a complete sub-section for transfusion, but in some ways this just makes the manual even more long-winded than ever. I haven't seen one that is less 30 pages yet.

We need to lean these documents so they become purposeful, not just to please accreditation bodies.

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Thanks Malcolm, could be you're in a better mood because it's nearly Christmas???

I like the idea of a complete sub-section for transfusion, but in some ways this just makes the manual even more long-winded than ever. I haven't seen one that is less 30 pages yet.

We need to lean these documents so they become purposeful, not just to please accreditation bodies.

30 pages! Goodness me, we send ours away to be bound!

Bah humbug, by the way. It's not even December yet. There is still a VERY important date to come before 25th December.

:mad::mad::D:mad:

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Our Transfusion Medicine department has their own Quality Manual, separate from the main Clinical Pathology. It seems to work best for us in Blood Bank since we have very specific standards and regulations from the rest of the Lab, although we do share some Quality Policies with the main Clin Path.

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Hi Guys,

Yes we have ours separate. For ISO we deliberately called it the Quality Policy of the Blood Transfusion Service (as it involves practices hospital wide) and it includes Haemovigilance and other clinical matters.

Layout is same as for rest of lab as I numbered clauses in the QM to answer requirements (same clause numbers) of ISO15189. Makes life simpler.

Cheers

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Hi Rashmi,

I have 3 seperate Quality manuals in play at the moment, the generic Pathology wide one for CPA, the BT specific one which encompasses haemovigilance etc, and a HTA hospital wide one as I have HTA responsibility too.

I came to the conclusion pretty rapidly that CPA would query the inclusion of things outside of the labs control if I merged them so there are 3 distinct Quality management systems in play too. but each one follows the format approved by CPA, and developed further to encompass all the other regs and requirements.

the dreaded C season doesn't start until after the school Carol concert, I cannot be dealing with it before then!!! and as a child it didn't start til 24th December as my sister's Birthday is 23rd December and she had to have her birthday first!!

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Quite right too (not that my birthday is on the 23rd mark you, but it is before Christmas)!!!!!!!!!!!!!!!!!!!!!!!!

:D:D:D

And here in the US, we still have Thanksgiving...not that anything could be more important than the day Malcolm arrived into the world.

On the issue to hand, I believe that the Transfusion Service should have a separate quality manual. I think when the rest of the lab catches up to the level of quality required in transfusion (if ever), each section would need to have some separate quality policies specific to the area. Some quality policies could be integrated, like document control and equipment control. We have not tried the ISO yet, Eoin, did your whole lab go ISO or was it just Transfusion?

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Thanks everyone, I agree it does look like a separate manual would be the best, though certainly not the leanest way. What ever happened to integration?

[QUOTE=adiescast;21149]And here in the US, we still have Thanksgiving...not that anything could be more important than the day Malcolm arrived into the world.

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Thanks everyone, I agree it does look like a separate manual would be the best, though certainly not the leanest way. What ever happened to integration?

[QUOTE=adiescast;21149]And here in the US, we still have Thanksgiving...not that anything could be more important than the day Malcolm arrived into the world.

You really shouldn't enourage him adiescast, he will soon become very very unbearable!!!!!

I think Jo has definitely taken the prize for managing 3 manuals. I'll try not to mention the 'C' word for the next few weeks, but i'm sure Malcolm will try to remind us, so will need to come up with some suitable insults if I can.

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