How do blood collection centers manage subsequent donations by donors who choose the confidential unit exclusion ('CUE') option?

The medical director of a hospital-based donor center reports that they are currently reviewing their donor suitability/deferral criteria. They had previously made it a policy to defer all donors who chose the "Do not use my blood" self-deferral sticker for one year. However, this was just based on the assumption that donors were deferring for HIV-related reasons. From their experience, they know that donors may be deferring themselves for other reasons that might not normally be a one year deferral. Some may be less but some may be more including permanent deferral. In addition, they have had regular donors who have chosen the "do not use" sticker and then show up for their next regular donation. They have turned these donors down since their policy stated that a one year deferral was manditory. All the regular donors have then stated that they did not intend to use that sticker and that they have no reason for deferral. The inquiring physician is interested to learn how other centers handle this since she cannot find any standard rule for length of time for deferral.

The following responses were received.

ADDENDA April 4, 2003

1. One of the regional medical directors for United Blood Services (UBS/BSI), the second largest blood collection agency in the US, comments that donor deferral stickers are problematic because they are often inadvertently applied incorrectly. The responding colleague reports that they do not use stickers. Instead, a card is provided with a product identification number as well as a toll-free phone number that the donor may call and leave a message if they do not want their blood used for any reason. The most common reason is that they feel ill later in the day from a cold, flu, etc. This covers both predonation and postdonation concerns. If the reason is unclear, then the center attempts to contact the donor to determine the appropriate deferral period. If they are uncertain of the reason, then the donor is deferred until further information is available.

ADDENDA April 6, 2003

2. A colleague in Texas reports that their center continues to use CUE stickers. They considered an alternative donor call-back system, but felt with their quick product release (in 24 hours, sometimes less), donors may not call back in time to keep the products from being shipped and possibly transfused. CUE stickers make them choose an option while they are in the center. Call-back policies (as in response #1 above) rely upon the donor to do something on his/her own sometime in the future, and relying on the donor to make the notification is a policy with which the responding colleague's donor center is not comfortable. Finally, the Texan adds that their policy for years has been to treat units donated with a "don't use my blood" CUE choice as UNIT deferrals, NOT DONOR deferrals. Therefore the unit is destroyed, no matter what the test results, but the donor is not deferred. Donors who were deferred many many years ago when the blood center policy was to defer indefinitely are now reentered upon donor request. The donor must sign a statement that they have no HIV risk factors and that they chose the CUE sticker by mistake.
   
   
3. In view of the known preponderance of mistakenly applied 'Do not use' CUE stickers, a retired ARC medical director in Northern California wonders what centers do about directed donation units found to have such a label. A very sticky situation in his experience.

ADDENDA April 7, 2003

4. A colleague in Pennsylvania (Ronald E. Domen, MD Professor of Pathology, Medicine and Humanities Medical Director, Blood Bank and Transfusion Medicine Director, Milton S. Hershey Medical Center, Penn State University College of Medicine published the results of a national survey on the use of the CUE in the Archives of Pathology & Laboratory Medicine in November 1995 (Vol. 119, pages 1007-1011) The survey may or may not be applicable to practices today. Over 400 institutions were surveyed on various CUE policies and practices including number of CUE uses allowed before permanent deferral, reinstatement policies after the use of CUE, etc. If any blood banker does not have ready access to a medical library, Dr. Domen would be happy to fax a copy of the paper.
   
   
5. A colleague in Rhode Island reports that her center dropped the CUE because they found that donors did not understand it. They even had donors that used CUE on their own autologous blood donation thinking they needed to check the CUE in order to get their own blood back. They maintained the system where the donor can call back to the center to discard their blood without giving the center any reason. The allogeneic donors that had used CUEs in the past return to donate and don't even realize they had requested to have their blood thrown away when they are asked about the past use of CUE.
   
   
6. A colleague who works within the American Red Cross system (unlike the retired ARC guy who teaches part-time at Stanford) reports that current policy for CUE is that when a CUE sticker is detected, the unit will not be used for transfusion. However, the donor will not be deferred based on using the CUE sticker. The donor will be tested and may be temporarily or indefinitely deferred based on test results, not on the CUE sticker. Use of the CUE sticker does not affect the donor's future ability to donate. The responding colleague is not aware if FDA or AABB have any "official" policy on CUE, but offers the following references (which are pretty old):
   • Petersen LR; Busch MP. Confidential unit exclusion how should it be evaluated? [letter; comment] Transfusion. 1991 Nov- Dec;31(9)869-71.
   • Domen RE. The confidential unit exclusion and allogeneic blood donation. Results from supplementary questions to the Donor Center and Viral Markers surveys of the College of American Pathologists. Arch Pathol Lab Med 1995 Nov;119(11)1007-11

ADDENDA April 9, 2003

7. A colleague in Central California reports that their blood center discontinued using CUE stickers some time ago. They report having had problems with the donors using the wrong stickers for various reasons. In place of the stickers, the donors are told that they may stop the donation process at any time before making the donation with no questions asked. Additionally, they give donors information regarding post-donation deferral of their units through the use of a confidential call-back line. This information, along with the unit number is provided to the donor upon completion of the interview process. In the years that they have used this call-back system, they have had only one incident of an HIV-positive donor calling back to exclude their unit. The other 99 percent of calls have been for symptoms suggesting flu, colds, etc.

ADDENDA April 14, 2003

8. A transfusion medicine physician in Southern California reports that his regional blood center has a unique approach to employing a CUE system. Here is what the colleague reports as their approach (verbatim):
   
   "When a donor applies the "DO NOT USE" sticker, the unit is discarded and the donor is sent a letter thanking them for telling us that they have been exposed to AIDS and that they are permanently deferred. This letter generates an instant response in about 1/2-2/3 of donors, who call to tell us it was a mistake. At that point we send them another letter with a questionnaire (the high-risk activities questions) which, if filled out and sent in, is reviewed by a medical director and (assuming the answers are all appropriate) the donor is reinstated. Those donors who do not call us are left in the permanently deferred status that appears to be appropriate. We like the system and published an abstract at the AABB meeting in San Francisco a few years ago showing that CUE positive donors had a significantly increased risk of being HIV-reactive as compared to CUE-negative donors; ergo, we feel it is worth the hassle."

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