Policy: Donor Notification of Abnormal Results

Enumeration:  5.8

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.

Policy:

  1. All policies and processes must meet applicable local and national standards and laws as well as international accreditation standards (e.g. JCI, CAP, AABB, CE, ISO).
  2. Donors with abnormal results will be counselled after the completion of the testing algorithm.
  3. Testing algorithm built with Medinfo Hematos IIG blood bank donor software will be used.
  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.
  5. A Transfusion Medicine physician will counsel the affected donor confidentially in a timely manner.
  6. If the donor cannot be contacted, details of the contact attempts will be added to the donor’s records in Medinfo.
  7. 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