Critical supply log

[amym1586]

AABB wanted me to change our Supply log.  They wanted a way to document if the supply was unacceptable.  I had to add the In service date.  And they want me to add something to the tune of  whoever received in the supply  is checking it to see if the package insert is the same or has it been updated.  And then some wording in a procedure as to what we do if the package insert is new/updated.

 

We previously had  OK to signify that we checked the package/  OK that we checked to package insert.    They didn't like that. 

I attached the one I'm working on but it may need help.

Any advice/helpful comments?

BB.F.SUPPLYLOG2.odt

[David Saikin]

Be proactive for you operation.  Tell AABB what your process is and let them decide if you need to "upgrade it" to what the inspector says.  In my QP it says that I evaluate the new pkg inserts and update procedures as appropriate.  If you think your current process meets the standard, and I quote from the 30th Edition:  "Incoming . . . and critical materials shall be received, inspected, and tested, as necessary, before acceptance for use".  and "Critical materials shall meet specified requirements".

If AABB doesn't like your process they will let you know and THEN you can modify your processes.  It's up to you.  I am always proactive for my operation and usually win about 60% of the time if I challenge the inspection.  The inspector is NOT always right in interpreting the standards. It's not all black and white anymore.

Edited April 26, 2016 by David Saikin
upgrade grammar

[amym1586]

Thank you! I know I'll be better at this next time with 2 more years under my belt.   It is hard to sort out some times the inspectors suggestions/ nit pickiness based on actual standards and things we need to change.

 

We had written that we check the package insert for any changes  but no wording with what the procedure is for if there is a new package insert.  The same for product integrity.  We check to see if the supplies look ok, no damage, spills etc. But no wording as to what we would do if the product was unacceptable.  

 

They were cross referencing with CAP so sometimes it was also unclear if it was a CAP thing are an AABB thing.

Kind of hard to see that you have to have a package insert procedure out of "materials shall be received, inspected, and tested, as necessary, before acceptance for use". 

[goodchild]

We actually do what you do. A checklist of things that people are required to check.

We have a blurb that if something is updated, the package inserts binder is updated, the old copy retired, and then we determine any need to make people specifically aware if there are substantial changes.

If something is unacceptable it goes on quarantine log for supervisor to follow up on, etc.

My critical materials log doesn't have the 'in service' date because that would be in our QC manual.

[SMILLER]

But do you have a checklist for those who check the checklist?

Scott

[AMcCord]

One small thing I've added to the process of receiving reagents is a small self-inking stamp. It has checkboxes for the following: No Product Insert Changes, Change to Product Insert(s) (circle item # on invoice if new insert version), and Supervisor notified if changes to insert version. At the bottom are lines for the received date and tech initials. We have a log for all the important info - what, when, lot#, outdate, looks OK, QC performed, etc. In that log I have a document that lists the current insert version for all the reagents coming in so that the techs can do the insert version check. I keep that list updated and they keep me updated on lot changes. I'm in the process of adding a more detailed procedure for receiving reagents and supplies (trying to keep ahead of the inspection curve!).

[mollyredone]

I am attaching a copy of our reagent quality assessment. We separate our products specifically and have a binder with all the package inserts and then document lot, receipt, in use, expiration date and inspection. This form goes behind the package insert, so we can see it.

BB REAGENT LOT.xls

BB RM Quality Assessment of Received Reagents.doc

Edited April 27, 2016 by mollyredone
removed double posting

[amym1586]

40 minutes ago, mollyredone said:

I am attaching a copy of our reagent quality assessment. We separate our products specifically and have a binder with all the package inserts and then document lot, receipt, in use, expiration date and inspection. This form goes behind the package insert, so we can see it.

BB REAGENT LOT.xls

BB RM Quality Assessment of Received Reagents.doc

Oh I like the idea of separating the products in a log book with the package inserts!    I might have to steal that idea.

[David Saikin]

20 hours ago, amym1586 said:

They were cross referencing with CAP so sometimes it was also unclear if it was a CAP thing are an AABB thing.

 

If you are having an AABB inspection they should not be using the CAP Standards.  Granted, they are pretty close BUT for AABB you need to be in compliance with AABB Standards.  And if you are, you will be in compliance with CAP (maybe not vice versa).

I'd call AABB and talk with the I&A folks about your inspector's interps on things esp using the CAP standards . . . The only other regulatory agency I would utilize during an inspection is the FDA.

Also - become an AABB Assessor.  It's a pretty easy thing to do and will give you a better perspective on that process.

[amym1586]

24 minutes ago, David Saikin said:

If you are having an AABB inspection they should not be using the CAP Standards.  Granted, they are pretty close BUT for AABB you need to be in compliance with AABB Standards.  And if you are, you will be in compliance with CAP (maybe not vice versa).

I'd call AABB and talk with the I&A folks about your inspector's interps on things esp using the CAP standards . . . The only other regulatory agency I would utilize during an inspection is the FDA.

Also - become an AABB Assessor.  It's a pretty easy thing to do and will give you a better perspective on that process.

In one of the emails of hers that I read it had that we requested an AABB and CAP coordinated visit and it enclosed the CAP checklist for her to go over as well.   I'm not sure if that's to keep the blood bank from getting inspected twice or not.

 

I have looked over some of things involved in becoming an AABB Assessor. I'd love to be able to see how other people do things and steal the good ideas!

[David Saikin]

I have done many AABB/CAP coordinated inspections sooooooo - I guess using both is actually ok in this instance.  It does keep you from getting inspected twice.

[amym1586]

On ‎4‎/‎27‎/‎2016 at 7:22 AM, AMcCord said:

One small thing I've added to the process of receiving reagents is a small self-inking stamp. It has checkboxes for the following: No Product Insert Changes, Change to Product Insert(s) (circle item # on invoice if new insert version), and Supervisor notified if changes to insert version. At the bottom are lines for the received date and tech initials. We have a log for all the important info - what, when, lot#, outdate, looks OK, QC performed, etc. In that log I have a document that lists the current insert version for all the reagents coming in so that the techs can do the insert version check. I keep that list updated and they keep me updated on lot changes. I'm in the process of adding a more detailed procedure for receiving reagents and supplies (trying to keep ahead of the inspection curve!).

The thing I KNOW I'm going to get complaints about is Ortho doesn't put package inserts in anything anymore. Just instructions on how to look up the package inserts.  But they'll put a notice that they changed something, but they have a notice in their boxes from an updated they made Oct. 2015! 

[SMILLER]

Those silly Orthoniacs!

When we enter in reagents, we have a field for the insert date. (I would think most systems do).  Our procedure for checking in reagents states that when one checks for a newer insert, that the coordinator is notified so proper changes are made (if any) to our procedures.  The entry of that insert date documents that this has been done.

So we do have a book of insert copies, but only check them against Ortho's internet listing when we check in a new batch of reagents.  There is no written logsheet.

Scott

 

Scott