Process: Donor Notification of Abnormal Results

Enumeration:  5.8.2

Principle:

AABB requires that all donors be notified and counseled of abnormal test results in a timely manner.  Notifications should be done based on required AABB and/or CE protocols including the requirements for follow-up testing at specified intervals.

Process:

  1. Blood components prepared from donors with abnormal blood results will be discarded according to current SOPs unless a variance is approved by a transfusion medicine physician.
  2. Abnormal results will be handled according to the current Abnormal Marker Testing Algorithm in effect.
    1. Additional testing after specified time intervals may be necessary depending on the initial results.
  3. Medinfo Hematos IIG will automatically follow the donor marker testing abnormal result algorithm and quarantine the affected units.
  4. All abnormal test results will be reviewed by the Division Head, Transfusion Medicine or other Transfusion Medicine Physician in a timely manner upon completion of the testing algorithm and any other additional testing that has been ordered.
  5. A Transfusion Medicine physician will counsel the affected donor.
  6. Counseling will only be performed when the ALL specified test results are available.
  7. Donors will be counseled as soon as possible but within 8 weeks of completion of the test algorithm.
    1. All counselling must be done confidentially.
    1. A letter for the donor explaining the contraindication will be prepared and given to the donor at the time of the counselling session.
    1. Positive identification of the donor must be confirmed before counselling or releasing any results.
    1. If the donor cannot be contacted, details of the contact attempts will be added to the donor’s records in Medinfo Hematos IIG.
  8. Donors will be offered referral to the appropriate clinic (e.g. Infectious Disease) for treatment and/or further assessment.

References:

  1. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  2. Guidelines to the Preparation, Use, and Quality Assurance of Blood Components, European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), Current Edition
  3. Guidance for Industry, Donors of Blood and Blood Components, Small Entity Compliance Guide, US Department of Health and Human Services, Food and Drug Administration,  Center for Biologics Evaluation and Research, June 2011
  4. Interim Policy Abnormal Marker Testing Algorithm, Current Edition