Hi Everyone,

Does anyone have an official list of what they define as "rare" BB antisera? I'm doing my CAP self-inspection and the requirement TRM.31250 discusses using "rare" reagents past their expiration date as long as QC works. No prob with that but it also states The laboratory should establish criteria defining which reagents are considered "rare.".......The reagents are unique, rare or difficult to obtain; or delivery of new shipments of reagents is delayed.

Would it be sensible to create a list for the techs (and inspectors) to refer to?

The "rare" reagents are usually considered your ag typing sera with the exception of ABO and Rh antisera.

It would behoove you to have a list of "rares".

Thanks David,

I'll not include every special antigen typing sera, as I don't think it's right to use an expired Anti-E (for example, among others) because it's not difficult to obtain.

Becky

How about cost? Apparently the Anti-S antisera is over $1000/vial.

Try buying from HemoBioscience. It is less expensive.

Thank you for the info, David.

I agree with Becky, I think if you can buy it readily there's no reason to use outdated antisera. (Would you do that with anti-A, -B or -D??) We define "rare" as the standard does ; out of stock, unobtainable, on order. If you're worried about the cost of an unused, outdated vial, many people just don't stock the ones they rarely use (anti-Fyb, -Jkb, -s etc.) and rely on their blood supplier to furnish antigen-negative units. Don't forget to include selected reagent red cells on the list. There have been several threads as to their use.

Try buying from HemoBioscience. It is less expensive.

Not really by much. I believe HB is only 3mL instead of other company's 5 mL bottle.

For those uncomfortable with using expired antisera, you can mass screen with expired stuff, and retest negatives with in-date antisera.

I almost got cited for this a few days ago because I have expired anti-Jka in the refrigerator and my policy defines anti-Jka as 'rare'. I was told that only reagents that aren't readily available like anti-Cw are rare.

Not really by much. I believe HB is only 3mL instead of other company's 5 mL bottle.

For those uncomfortable with using expired antisera, you can mass screen with expired stuff, and retest negatives with in-date antisera.

Actually the anti S from Hemo bio is 5 mL's

The FDA defines rare antigen typing reagents as Jka, Jkb, Fyb, S, s in their compliance guides. There is a paragraph about rare antigen typing reagents in Attachment C.

http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/CompliancePrograms/UCM239615.pdf

Such a gray area, I decided not to use any expired reagents.

Found it. I knew I saw a list somewhere.

FDA Compliance Program Guidance Manual

Chapter 42 - Blood and Blood Products

Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001

Implementation Date: *When posted* Technical Update Dec. 2010

Completion Date: Ongoing

Rare antigen typing: Some blood establishments use expired, commercial, rare antigen typing reagents (e.g., Jk a, Jk b, Fy b, S, s) when in-date reagents are not available. In some instances, a blood establishment may choose to use serum or plasma from a patient or donor who has a rare antibody for rare antigen typing when commercial reagents are not available. The blood establishment should only use those expired reagents or sera/plasma in an emergency with the approval of the medical director, and only when appropriately tested with positive and negative control cells.