Addenda: May 6, 2004; Aug. 5, 6, 8 & 9, 2005; Mar. 22, 2009

Policies on the use of autologous units that test positive for HIV, HBV and/or HCV

A physician in Northern California reports that his institution's current policy regarding autologous blood products is to neither store nor to transfuse HIV-infected autologous products. However, the same institution will store and transfuse HCV and HBV infected products. The Northern California colleague freely admits that their policy is inconsistent in that it restricts the use of HIV-infected autologous blood, but does not restrict the use of hepatitis-infected autologous blood. Their hospital Transfusion Committee has debated this issue at length, and after repeated consultations with institutional Risk Management, the institution is coming to a conclusion that their current policy may have legal (and ethical) concerns, including compliance with the Americans with Disabilities Act. On the other hand, members of their Transfusion Committee are concerned about an increased risk that might accrue to their patients. If they were to adopt a policy of accepting HIV-infected units into the Transfusion Service for storage, they are concerned of the risk that such a unit could be unintentionally transfused to the wrong patient. In the Northern California physician's opinion, the concern over mistransfusion clearly extends to the HCV/HBV units as well. He wonders if colleagues of the e-Network Forum whose Transfusion Services/Hospitals currently accept infected autologous units (HIV, HBV and/or HCV) would comment on any special procedures that have been put in place to give additional safeguards against blood being issued to the wrong patient (specifically, procedures that call for unique storage, tracking, handling and/or dispensing mechanisms that differ significantly from those used for uninfected products. His institution feels strongly about taking all reasonable steps in order to mitigate any increased risk that accepting these units might present, and are very interested to assess the processes used at other facilities prior to making a final decision on this issue.

The following replies were submitted in response to the above:

1. The Editor points out that at the University of Southern California (USC) the policy is to NOT store or transfuse autologous blood products that are known to be infected with HIV, HBV or HCV. However, the approach taken at USC is not the predominant one in the USA, as a recent Proficiency Testing Survey by the College of American Pathologists (Surveys 2003: J-C) revealed that of 3561 transfusion services surveyed, 2988 (83.9%) reported that they stored and/or transfused units of autologous blood products in their hospitals. Of those 2988 respondents, nearly two-thirds stored and/or transfused autologous blood products that were known to be infected with HIV. Nearly three-fourths of those respondents stored and/or transfused autologous blood products that were known to be infected with HBV or HCV. Important to this discussion, however, is the fact that at present, no system has been developed that absolutely guarantees with 100% confidence that an infected autologous blood product will not be accidentally transfused to the wrong recipient. For more details about this issue, see the prior eNF discussion.

ADDENDA May 6, 2004

2. A colleague in Switzerland who is involved with their national haemovigilance program reports that donors of units of autologous blood products must be tested according to the same requirements as donors of allogeneic units, except testing for HCV-RNA and HIV-RNA by NAT is not required. All autologous units which are repeat reactive in screening tests for HBsAg, or for antibodies to HCV or antibodies to HIV must undergo confirmatory testing. If confirmatory testing is negative, the autologous units may be transfused, but the patient's attending physician makes the final decision. If confirmatory test results are not "negative," the autologous unit must be destroyed, and therefore is not available for transfusion. This stringent policy is in place to prevent the transmission of a viral infection, due to transfusion mismatch. International data show that mismatches are one of the greater risks of transfusion therapy. The Swiss colleague says that as a policy, they do not want potentially infectious units in their supply chain. She adds that in addition to the Swiss policy to destroy autologous blood products with a confirmed test for evidence of infection with HIV, HCV or HIV, blood banks in Switzerland must also keep autologous and allogeneic units separated during storage in the blood bank.
   
   
3. A transfusion medicine physician in Chicago reports that his hospital uses portable refrigerators in the OR for liver transplants and trauma surgery. If they have an HIV-positive autologous unit for surgery, they issue it in a portable refrigerator by itself to the patient's operating room. Blood coolers could be used similarly. This avoids putting it in the regular operating room refrigerator with other units for other patients.

4. The Editor suggests that others might be interested in reviewing the recently published article: Shulman, IA; Osby, M. Storage and Transfusion of Infected Autologous Blood or Components - A Survey of North American Laboratories. Arch Pathol Lab Med. 2005 Aug;129(8):981-3.

ADDENDA Aug. 6, 2005

5. A transfusion medicine physician in Spain reports that there are deferral criteria for autologous donors (and their donations) according to the COMMISSION DIRECTIVE 2004/33/EC of 22 March 2004 for implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components.
   
   Specifically, section 2.4. lists the following criteria as deferral criteria for donors of autologous donations:
   • Persons with or with a history of:
     • hepatitis B, except for HBsAg-negative persons who are demonstrated to be immune
     • hepatitis C
     • HIV-1/2
     • HTLV I/II
   The Directive does allow Member States to establish specific provisions for autologous donations by such persons.
   
   Based on the above Directive, the Spanish colleague reports that at his blood bank they discard autologous units that are infected with HIV, HBV or HCV. He adds that in his opinion, a positive donor can not get a significant benefit from this kind of donation, but that such a donation represents too great a threat to the blood supply and staff safety, in case an accident happens.

ADDENDA Aug. 8, 2005

6. A colleague in Arizona reports that the CAP survey published by Shulman and Osby (Storage and Transfusion of Infected Autologous Blood or Components - A Survey of North American Laboratories. Arch Pathol Lab Med. 2005 Aug;129(8):981-3) has sparked discussion on the topic of handling infectious autologous blood products at both the Technical Advisory Committee and Medical Advisory Council (M.A.C.) in Phoenix. She reports that with the help of hospitals supplied by UBS-AZ, they been attempting to establish a community standard for handling autologous products with positive viral markers. After a great deal of thoughtful discussion, the consensus is as follows:
   1. confirmed viral positive units would be destroyed by the blood center upon identification except in instances of rare medical exceptions,
   2. subsequent units would not be drawn from the donor, and
   3. the blood center would no longer maintain these units in inventory until expiration.
   As of the last M.A.C. meeting, the majority of hospitals had concurred with the proposed community standard. The M.A.C. is still communicating with a small number of facilities that have not responded to the council's initial letter.

ADDENDA Aug. 9, 2005

7. A colleague in Spain reports that his center recently published a 14 years' experience of infectious disease markers in our autologous and first-time volunteer donors: Hernandez, JM et al. Infectious disease markers in autologous blood donors and first-time volunteer blood donors: 14 years' experience in a blood center. Haematologica 2004;89(7):889-91. In that study, they report that the proportion of donors with positive markers for HBsAg, anti-HCV and syphilis was statistically higher in the autologous group than in the first-time volunteer donor group. The proportion of donors with a positive result for anti-HIV was similar in the two groups. Their current policy is to defer an autologous donor who is positive for one of these tests.

8. A California colleague is interested in an update about how other institutions currently handle autologous units that test 'positive' for infectious disease markers; specifically if there has been any increase in institutions not collecting or storing such units. At present, the inquiring colleague's institution attempts to dissuade autologous donations from individuals known to be infected with a transmissible viral infection, giving the reasons of hazard to unintended transfusion recipients, etc. While the vast majority of known positive autologous donors agree to not have their units collected or used, a small minority vociferously demands to have their autologous units available, regardless of risk to others."
   
   
9. Editors' note: The following articles seem germane to this updated discussion:
   • Brooks JP, Ferrell JE. Legal and Ethical Considerations in the Transfusion of Infected or Untested Autologous Blood. Am J Clin Pathol. 2007 Jul;128(1):135-42.
   • Stefanie Shulman-Cutler, Note, The AABB’s Autologous Blood Donation Suggested Guidance: Autologous Blood, HIV, and the Americans with Disabilities Act, 46 Jurimetrics J. 407–419 (2006).

Submit comments to the e-Network Forum at enetworkforum@cbbsweb.org

Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator