rcollins Posted September 19, 2012 Share Posted September 19, 2012 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? Link to comment Share on other sites More sharing options...
David Saikin Posted September 20, 2012 Share Posted September 20, 2012 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". Link to comment Share on other sites More sharing options...
rcollins Posted September 21, 2012 Author Share Posted September 21, 2012 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 Link to comment Share on other sites More sharing options...
bldbnkr Posted September 21, 2012 Share Posted September 21, 2012 How about cost? Apparently the Anti-S antisera is over $1000/vial. Link to comment Share on other sites More sharing options...
David Saikin Posted September 25, 2012 Share Posted September 25, 2012 Try buying from HemoBioscience. It is less expensive. Link to comment Share on other sites More sharing options...
bldbnkr Posted September 25, 2012 Share Posted September 25, 2012 Thank you for the info, David. Link to comment Share on other sites More sharing options...
Dr. Pepper Posted September 26, 2012 Share Posted September 26, 2012 I agree with Becky, I think if you can buy it readily there's no reason to use outdated antisera.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 If you're worried about the cost of an unused, outdated vial, many people just don't stock the ones they rarely use (anti-Fyb, -Jkb, -s etc.)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. Link to comment Share on other sites More sharing options...
GilTphoto Posted September 27, 2012 Share Posted September 27, 2012 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. Link to comment Share on other sites More sharing options...
Kathy Posted December 7, 2012 Share Posted December 7, 2012 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. Link to comment Share on other sites More sharing options...
noelrbrown Posted December 7, 2012 Share Posted December 7, 2012 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 Link to comment Share on other sites More sharing options...
DPruden Posted December 8, 2012 Share Posted December 8, 2012 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 Link to comment Share on other sites More sharing options...
tbostock Posted December 9, 2012 Share Posted December 9, 2012 Such a gray area, I decided not to use any expired reagents. Link to comment Share on other sites More sharing options...
tricore Posted December 13, 2012 Share Posted December 13, 2012 Found it. I knew I saw a list somewhere.FDA Compliance Program Guidance ManualChapter 42 - Blood and Blood ProductsInspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001Implementation Date: *When posted* Technical Update Dec. 2010Completion Date: OngoingRare 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. Link to comment Share on other sites More sharing options...
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