Regulation to record temp of products packed to ship out?

[Mabel Adams]

Can anyone cite a regulation (or give another good reason) for recording a temperature for products that are being packed in a blood box for shipment to another hospital?

Traditionally there was a statement on transfer forms of assurance that products had been properly stored while in our care, but I don't recall having to record at the time of packing of the units an actual temperature (or the refrigerator they came out of). Am I missing something?

We have a long-standing policy at my current workplace to record temps on shipments (as well as incoming units) and I am trying to find out why.

[Malcolm Needs ☆]

Audit trail? I don't know, I'm just making a suggestion.

[JOANBALONE]

If you are using transport boxes that were validated to keep temp for a certain amount of time then I don't think you would need to record temps prior to packing and at receipt.

[Auntie-D]

I think it's overkill. If that information is required it would be akin to wanting the temperature history for the fridge for the whole time of storage. As long as traceability is maintained, cold chain is assured.

[Deny Morlino]

I do not disagree with the above posts, but did have an inspector several inspections ago that would not allow us to accept ARC's massive validation of the transport boxes they use for shipping blood products and required us to document product temperature on the invoices upon receipt. Seemed like overkill to us, but it was an easy adjustment. For the record, there has not been a single product out of temperature specifications upon receipt for over 6 years since this was implimented at our facility (go figure).

[Auntie-D]

...inspector several inspections ago that would not allow us to accept ARC's massive validation of the transport boxes they use for shipping blood products and required us to document product temperature on the invoices upon receipt.

This is essential though But to document the temperature of the fridge the blood is coming out of is overkill. The originating hospital documents their own cold chain and it is taken upon faith that this cold chain has not been broken. But should we take it on faith???

[JOANBALONE]

I have found that inspectors can be wrong in their interpretations of the requirements. I think this may be a good example. I would have no problem accepting ARC's validation of the blood boxes. I hope you challenged the deficiency (if you were given one).

JB

[Malcolm Needs ☆]

i have found that inspectors can be wrong in their interpretations of the requirements.jb

SURELY NOT?????????????!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

:shocked::shocked::shocked::shocked::shocked:

[dgibaud]

The current CAP checklist question (TRM.42460) regarding shipping blood states "For blood/blood components shipped outside of the facility, procedures have been defined for proper packaging to prevent damage and control storage temperatures." I would assume that if you have a good procedure, and have validated "control" of your storage, you should be OK. Can you prove to your inspector that if you pack components as described by your procedure, will they stay in temp range for a reasonable period of time? That's the only regulation I could find.

[David Saikin]

Inspectors sometimes misinterpret the standards (sorry Malcolm). Before I would change anything I thought was valid I would challenge the citation (unless it comes from the FDA). I win about 70% of the time. The red cross validation of their boxes is valid when they are shipping. When we ship we use temp control devices to verify environment maintenance. We don't always get them returned, but the ones which come back provide documentation for our process.

[Mabel Adams]

Yes, we may have had an overzealous inspector once years ago. We had to validate that the way we pack blood boxes maintains temp (since we didn't weigh the ice to be sure we packed it according to ARC policy and probably used less ice sometimes for our 3 hr shipments) so I think we have our bases covered on all points made above. We plan to turn on the computer function to capture temps and it only captures them on receipt & return, not shipping out. Now I think we can quit recording the outgoing temps and quit storing all of that paper for 10 yrs. Thanks everyone.

[Malcolm Needs ☆]

I do know that, when the NHSBT issues washed blood, it is not allowed to put it straight into shipping boxes, but has to allow it to get down to storage temperature first.

Why, is another thing!

[L106]

If you are using transport boxes that were validated to keep temp for a certain amount of time then I don't think you would need to record temps prior to packing and at receipt.

This is my interpretation also.

Donna

[Mabel Adams]

We are choosing to capture actual temp of delivered products even though it is not required. Since we can't get away with the old "30 min rule" on products returned from issue we are going to turn on the temperature capturing field in the computer and might as well do it for all incoming functions to keep things more simple and quit storing all of those paper records for 10 years. I just needed to verify that there was neither a regulatory nor a practical reason for recording a temp of products we are packing for shipment.

[tbostock]

Our LIS (SoftBank) requires us to do a visual inspection and document it as acceptable when shipping blood back to the supplier, but does not require the temp to be documented.