GCH LAB RAT

https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM425952.pdf
This is in Draft status, but should be finalized this year.  Once finalized, FDA will give 2 years for implementation.  Transfusion services should not be mandated to make changes until some time in 2019 or later.  There are some misstatements in some previous posts that should be clarified.
PAS apheresis platelets can be stored up to 5 days and must have a "safety measure" test within 24 hours of transfusion if transfused on Day 4 or 5.  The use of platelet additive solution does not confer any protection against bacterial proliferation. Plasma-stored apheresis platelets can be stored up to 7 days and must have a "safety measure" test within 24 hours of transfusion if transfused on Day 4, 5, 6, or 7. Pathogen reduced apheresis platelets can be stored up to 5 days and can be transfused up until expiration without additional testing.  

It isn't. That's why most blood suppliers went to pooling and pH testing (using the FDA approved methods) before shipping platelets.

We use the macopharma phlebotomy bags (600ml) with the luer lock. That way we can attach any size needle onto the bag.

We use the macopharma phlebotomy bags (600ml) with the luer lock. That way we can attach any size needle onto the bag.

Using expired antisera and panel cells is and has been standard practice for years in my experience. It has become more sound with additional QC people are now doing. If ever cited for this I would push back. Provide scientific rationale and a risk evaluation for what you are doing. These are tools used to solve problems. Without them your hands are tied and patients may not receive compatible blood. A bigger risk.
 
No matter what you call them (inspectors, investigators, assessors) they all have opinions and you may not be about to change their mind during the inspection. What they may cite you for during an inspection can be disputed in your response. The repsonse is typically reviewed by others.
 
Some of these things are just driving up the cost of health care without improving actual patient care.

Yikes! In past years antigen typing sera could be used beyond expiration as long as there was a policy for QC. We consider them to be "rare" partially as an expense. Yes they are available from the manufacturer, but they are very expensive. Private Lear Jets are also readily available from a manufacturer, but they are rare because few people can afford them!
We will be eating some expense to get our rack in-date within the next few weeks. Our CAP window will be opening soon.
We also use expired panel cells for rule-outs.....in fact a recent CAP Survey we had to use expired panel cells to identify an anti-U....nothing in-date was helpful.
Sounds like another case of a non-technical person making rules they don't understand.

I just got cited for this checklist item. When I spoke with CAP, this was the response:
 
TRM.31250 If expired reagents are used you must clarify that they were unavailable from the manufacturer at the time of use.
(I was speaking to her about antigen typing sera, not RBC's)
 
She stated that we must document in our records why we had to use the expired reagents (ex: on back order from manufacturer). I explained to her that we use expired RBC panel cells for rule outs ONLY and that we QC the panel with each use.  She was okay with that statement, but anti-sera had to be within date even if we had QC that gave expected results, UNLESS it was on backorder or unavailable.
 
So if hope this helps someone with this checklist item.

Attached is the checklist I borrowed from another institution.
BB Competency Check List.pdf

To answer a couple of the questions above: If we only thaw/pool and rarely aliquot RBC's, do we need to add a "modified by" label to the product? For pooling and aliquoting, yes.
Does it need to be barcoded? Yes. FDA requires that the Donation Identification Number, the ABO/Rh, the product code and the facility ID be bar coded (but not expiration date). The facility ID is part of the donation identification number in ISBT 128, so that's 3 bar codes. In Codabar, the facility ID must be bar coded separately. One thing to remember--only one facility must be bar coded on the label. So, if your blood supplier's ID is bar coded (within the unit number or elsewhere), you do not have to bar code your facility when you modify a product. The modifying facility ID would only have to be present as text.
What exactly will happen when we pool plts? Aside from creating a unique pooled unit #, we only have an ICCBBA facility ID, not an FDA one.
FDA accepts the ISBT 128 Facility Identification Number (FIN) as a unique identifier. The ISBT 128 Donation Identification Number includes this FIN, and meets the FDA requirement for a bar coded facility identifier when the unit number is bar coded. (In Codabar, the FDA registration number, CLIA number, or your ISBT 128 number may be used.) When you say you will assign a unique pool number, is that in the ISBT 128 format? That is, includes your facility ID-- For example W0000 08 123456?
Will we need to label the pooled product with that #? Yes.
Will it need to be barcoded? Yes.

Looking back at the orginial question: Yes, FDA in 21 CFR 606.121 © (13) requires machine readable (bar codes) for certain information: This includes ABO/Rh, product code, unit number and a facility ID. AABB requires that after May 1, these bar codes be ISBT 128.
You do NOT have to bar code more than one facility ID. It's generally the collection facility information that is bar coded. If they are using an ISBT 128 unit number (called Donation Identification Number in ISBT 128 terminology) the facility ID is embedded in that bar code. If you make up aliquots, you should be retaining the original unit number which has the facility embedded. Therefore, you don't need to bar code your own facility ID.
If you pool a product, you must assign your own unique pool number. Again, if you're using ISBT 128, your facility ID will be in this bar code, meeting the FDA requirement. If you are not using ISBT 128, you are correct, you would have to have an additional bar coded facility ID.
For thawed plasma and cryo, you do not need to do any re-labeling--other than change the expiration. Using the original product code bar code, even though it's for the frozen product, is perfectly acceptable in the US. You don't have to bar code the expiration date. In fact, as long as it's legible and indelible, you can hand write or rubber stamp it on the label.
I know everyone is finding this transition to ISBT 128 very frustrating, and I hear a lot of frustration directed at vendors. I'd just like to say a word on their behalf. This is new to them, too. They have worked very hard to understand the ISBT 128 standard and prepare their products. However, it's a complex standard as you know and software writers have learning curves, too. It's just so easy to have overlooked one important page or paragrpah, or even just one phrase on an example label. I know from the calls to our office that the vendors are trying very hard--just as you are. So, I guess I'm just saying we're all in this together. : )