We are starting to prepare for iso in our bb,

regarding traceability of reagents,

 

I do not think this applicable in blood bank, is it?

 

Any one has the experience with this?

It is just as applicable in a blood bank as it is in any other discipline of pathology.

I hope it never happens, but if you have a "blood bank related incident", such as an acute haemolytic transfusion reaction, causing major morbidity or even mortality, you may have to be prepared to defend your actions in court, and if you cannot prove that your reagents were in date, had been stored at the correct temperature, were used as directed by the manufacturers, etc, etc, etc, you could be in trouble.

 

7 hours ago, Dahboud said:

We are starting to prepare for iso in our bb,

regarding traceability of reagents,

 

I do not think this applicable in blood bank, is it?

 

Any one has the experience with this?

Can you copy and paste the exact requirement?

What exactly do YOU mean by traceability in this context, Dahboud?

Try looking at

https://www.iso.org/ics/71.040.30/x/

From what I understand, these standards apply to all areas of a clinical lab, including BB as Malcolm has pointed out.

Scott

Maybe I live in a bubble with my head in the clouds but I have never heard of this rule or ISO in general. Who would be checking on our compliance? TJC?

If you are documenting your daily QC, arrival conditions of reagents, refrigerator temps, have documentation of moving reagents when the fridge goes on the blink, etc. you should be covered. Am I missing something here? I went to look at the link but you have to buy it. Ugh! 

So many rules, so little time.

This rule would apply if you were applying for ISO accreditation(? - not sure they call it that).  ISO started in manufacturing firms and is a completely separate group of rules and inspectors.  Your blood distributor may be ISO - I think United Blood Services is, in the states.  The inspection would be with ISO qualified inspectors.  and yes - it undoubtedly costs money to apply and be inspected and accredited.

Edited April 6, 20178 yr by carolyn swickard

CSWICKARD- Thanks for the reply. You calmed me down a bit. I feel like I have my reagents under control. I just didn't want to be blindsided by a random inspector or TJC. Well I wouldn't be blindsided because I have documentation of everything. It just feels like all the rules multiply and become overwhelming.

For those of us in the US, we just need to follow whatever guidelines out inspection agencies prescribe.  JCAHO, FDA, CAP, etc all have to follow (at a minimum) CLIA standards for Lab stuff.  From what I understand, using ISO guidelines are for those facilities that do not otherwise have any oversight agency standards for the Lab.

Scott