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Posted: Oct. 15, 2001

Addenda: Oct. 15, 16.17, 18 & 22, 2001

 

Notification of patients and donors about abnormal test results related  to blood donor testing

A blood banker wrote that her donor center currently notifies ALL patients and donors by letter about ALL abnormal test results related to blood donor testing, including the following: 

  • presence of alloantibodies,
  • first-time reactivity for anti-HTLV I/II with negative/indeterminant WB/RIPA,
  • first-time positive test for Hepatitis B surface antigen not confirmed by neutralization with negative Hepatitis B core antibody.

The above approach generates numerous phone calls for explanations, even though a FAQ sheet is sent with the letters. The inquiring blood banker would like to know what other blood bankers do in these situations?


The following replies were submitted in response to the above:

  1. The Medical Director of a Blood Bank and Transfusion Medicine Service in Pennsylania commented that their current regional policy is to NOT notify those donors who are first time anti-HTLV-I/II reactive (neg/indet WB) or first-time anti-HBc reactive. All others are notified once they get back positive confirmatory tests. In their system, first-time HTLV and HBc reactive donors are eligible to continue donating. Once such donors have a second reactive test they are then permanently deferred. The responding Medical Director goes on to state "My personal opinion, however, is that all first-time donors who are reactive for these tests should be notified and the situation explained. If they then want to continue donating, then I would repeat the testing (anti-HTLV or anti-HBc) to make sure that it is now nonreactive/negative before allowing them to continue donating. Although donation is safe, my bias is to not unduly put someone through the donation process if it can be avoided by simply repeating the test(s) in question. This approach requires a little more work on everyone's part, but I think it is a matter of trust and the ethically right thing to do. Of course, you always run the risk that a subsequent donation will be reactive for one of these tests and then the donor will be permanently deferred, but I prefer going into the next donation knowing that at the present, at least, the testing issue has been clarified and that everyone is aware of what is going on and agrees to proceed. I think, in the long run, donors appreciate being a part of the decision-making process."

  2. A blood banker in Minnesota states that his facility sends out letters to all donors who test positive for any pathogen test (even first time anti-HBc ) since the test result may well result in their subsequent deferral for a second test and the donors may feel angry when they are told of their second positive without having been informed of their first positive result. The responding blood banker also resported that his facility was much more likely to make errors in the sending of letters if they tried to only send letters to those who were being deferred. They send out information sheets to be shared with the donors' physicians to help put these notifications in some perspective. The responding blood banker occasionally receives calls from donors who are confused or who have not carefully read the letter or its attached information sheet. Many of their donors work at their medical center (about 44%) and are often quite knowledgeable about the tests and their meaning. The responding blood banker states that he is sure this degee of medical sophistication on the part of many donors helps to reduce the number of anxious phone calls.

ADDENDA Oct. 16, 2001

  1. A blood banker in Sacramento commented that they report the same results as the inquiring blood banker, and in addition they also report positive direct antiglobulin test results, elevated bilirubin results and if plasma is grossly lipemic. The responding blood banker said that this approach does generate a significant number of phone calls, however, the medical personel of the blood center take turns answering the phone queries.

ADDENDA Oct. 17, 2001

  1. A retired blood banker from San Jose (who now teaches at a school that thinks trees can make good mascots) made the following comments in reference to contribution #3 above:

    "With the sensitive tests now used to screen donors for hepatitis B and C why would anyone still use serum bilirubin levels?" The responding blood banker added that in a study carried out in 7 healthy blood donors whose plasma was returned because it appeared icteric, all were found to have Gilbert's syndrome (GS), the commonest cause of mild unconjugated hyperbilirubinemia (Transfusion, 1996). To determine how common this was, bilirubin levels were measured in 298 frozen sera from healthy donors whose serologic tests were all normal on donation in 1996. Twenty-three (7.7%) had levels above 1.2 mg/dL (Transfusion, 1997, Supplement S308). This is consistent with the estimated prevalence of the GS gene (15%) among Caucasians, assuming only about half of carriers have elevated bilirubin levels at any point in time. Use of the test for hepatitis screening not only lacks sensitivity but also would result in an unnecessary burden on blood bank personnel, not to mention the anxiety provoked among donors.

ADDENDA Oct. 18, 2001

  1. A Blood Center in Ohio commented that they do the same thing regarding notification as the inquiring member, except they do not notify regarding alloantibodies. In addition, they also notify regarding use of the CUE barcode, since they regard the CUE barcode result as a test result (CUE = confidential unit exclusion).

ADDENDA Oct. 22, 2001

  1. A transfusion service medical director at a Community Medical Center in Central California states that there are defined recipient notifications that are required by FDA, notably HIV and HCV. At the opposite extreme are the vCJD lookbacks related to European traveler donors and extremely remote risk behaviors in donors who have since given many test-negative donations over many years. His facility's approach is a conservative one. When it is relevant, they insist on complete and up-to-date information from their blood supplier, such as how many times a donor was test-negative between the time a recalled unit was transfused and the present time, and if the lookback pertains to remote behaviors or exposures, how many times the donor was test-negative between that time and the time a recalled unit was transfused. For malaria, they distinguish between a casual traveler to an endemic area and a donor who was defined to have lived in the area. Virtually all -transmitted malaria cases are from the latter scenario. Their risk management officer receives copies of all proposed actions (more commonly, inaction), and they occasionally do receive a call to discuss a case. They have also sought guidance from their Pharmacy and Therapeutics Committee and even, on one occasion, their Ethics Committee. Those options are written into their SOP, which is written in such a way as to give flexibility aside from FDA-mandated situations. One frustration they sometimes have is that newly deferred donors are typically not offered relevant testing by the blood supplier. If a component from the donor's most recent prior donation was transfused, and there might still be a conceivable window period issue, it would be nice to know that the deferred donor is still negative for, say HCV. They have notified some recipients in the past because they didn't have this up-to-date information on the donor.

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Ira A. Shulman, MD
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