Awesome Variances

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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

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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)

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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

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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.

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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.

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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.

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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.

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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.

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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)

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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 _at_ Beth Israel in Boston (Transfusion
  report?) previously published efficacy of this
  variance.