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Awesome Variances

Awesome Variances. “First break all the rules” Carolyn Te Young & Jed Gorlin ABC 7/04. Variances: An underused tool. RIBC has been granted variances for: Tattoos: applied in licensed parlors Hemochromatosis: hct down to 34% 405-449 ml using 500 ml bag- may use

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Awesome Variances

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  1. Awesome Variances “First break all the rules” Carolyn Te Young & Jed Gorlin ABC 7/04

  2. Variances: An underused tool • RIBC has been granted variances for: • Tattoos: applied in licensed parlors • Hemochromatosis: hct down to 34% • 405-449 ml using 500 ml bag- may use • HIV WB indeterminate- case by case reinstatements following adverse lots • HCV RIBA indeterminate-case by case

  3. Exceptions and Alternatives approved under 21 CFR640.120 • “The director for CBER may approve an exception or alternative procedure to any requirement in subchapter F (biologics) of Chapter 1(Parts 600-680) of title 21 CFR. • Both licensed and unlicensed establishments must submit requests: Guidance for Industry: Changes to an approved Application: July 2001)

  4. Tattoos • First applied to AABB for variance: Deferred by AABB Standards and TTD committee pending review by FDA. • Granted by FDA for licensed parlors-limited to tattoos only, not other piercing • Granted by AABB Standards July 2002 • Single use needles AND pigments only

  5. Hemochromatosis • RIBC has standard variance allowing more frequent donations and not requiring labeling. • BUT, they also were granted the ability to draw donors down to a hct of 34% provided the donation volume is between 450-550ml using the 500ml bag. Logic: RBC mass > than 405 ml from donor with 38% hct

  6. 405-449 ml: Short units • In the event that less than 449 mls obtained from a donor with hct > 38%, but > 405 ml, then RIBC uses the unit as a regular unit, since the RBC mass exceeds that obtained from a standard draw using a 450 ml bag.

  7. HIV-Western blot indeterminate • MBC acts as confirmatory testing center for RIBC. MBC was using Calypte for HIV WB. Quality of HIV WB deteriorated significantly in 2001-2003, resulting in very high rate of unreadable or indeterminate WB. • One time approval for re-entry of selected donors affected by these tests allowed.

  8. Other one time donor variances • For a few individuals with HCV reactive ab, indeterminate RIBA and negative singlet NAT testing, approval for re-entry of donor has been allowed.

  9. Other approved variances • 21 CFR 606.65(e) • Use of NAT testing for other types of donors? • Use of EIA testing for specimens with high fat • 21 CFR 610.40 • Ship autologous blood untested (test subsequent unit) • 21 CFR 640.4, 640.11: Allow use of components exposed to temperatures up to 17C up to 2 hours and 15 minutes.

  10. Other approved variances (cont.) • 21 CFR 640.5 Allow syphilis testing on substitute sample drawn 1 day later • 21 CFR 640.11a Allow use of 325 RBC exposed to 1 to –3oC for up to 4 hours provided each unit examined for hemolysis! • 21CFR 640.34 Allow use of A and AB FFP warmed to –4C over an 18 hour period with consignee notification. Also allow FFP manufacture when frozen within 24 hours after collection.

  11. Ortho Hepatitis B sAg system 3 • This “new improved, more sensitive test” also had up to 10 fold more false positives! • Pending switch to alternative test, blood centers may apply for a one time variance to have falsely deferred donors reinstated after negative BioRad test. (UBS (+ others?) currently offering this reinstatement pathway testing)

  12. HCT variance for plateletpheresis • MBC will apply for variance to allow platelet collections from donors with 36% hct. Current machines lose few RBC if procedure halted. • European rules allow platelet donations at a lower hct. • Machines validated for use with lower hcts. • Kruskall @ Beth Israel in Boston (Transfusion report?) previously published efficacy of this variance.

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