Autologous Units Positive for ID Markers - Should they be collected and made available for transfusion?

As you recall, an institution informed the e-network that it does not accept, store or transfuse known infected autologous blood products for fear of transfusing an infected autologous unit to the wrong patient. This institution discards all autologous units that are CONFIRMED positive for HIV, HTLV, HCV or HBV. The institution inquired of the e-network what others were doing in this regard, because the inquiring institution is reconsidering its policy of discarding infected autologous units. While the inquiring institution is worried about storing units known to be infected with the above viral agents, for fear of transfusing such a unit to the wrong patient, see this abstract of a report on errors in transfusion in NY state by Linden JV et al in Transfusion, Oct., 2000. The inquiring member's institution is also concerned about the Americans with Disabilities Act (ADA) legislation . The inquiring institution was looking to the e-network to get a handle on the "community standard".

The above question stimulated considerable discussion, including a statement from the general counsel for the AABB. I have organized the replies so that the comments supporting discarding infected autologous units appear first, and the comments favoring storing and transfusing such units appear last.

The following replies were submitted in response to the above:

The following comments support discarding infected autologous units:

1. An institution in Virginia commented that its policy is to not accept any blood that would be labeled as biohazard or that would be discarded if the donation had been an allogeneic one. The institutions legal counsel (as well as an outside consulting attorney) think that the question of liability will boil down to a discussion of which is worse: violating the "rights" of an autologous donor who is HIV positive or transfusing an HIV positive unit of autologous blood to the wrong patient. Both attorneys had a different interpretation than that of the AABB (see below for the AABB interpretation) with respect to the ADA and the requirement to collect, store and transfuse HIV infected autologous donors. These attorneys felt that until the first case is tried, the "correct" legal answer will not be known. The Virginia institution's medical executive committee said that they would rather read a headline that an HIV positive individual was suing over discrimination, than read a headline that HIV was transmitted from infected blood that had been knowingly stored in their hospital inventory. The greatest challenge that this institution faces is making sure the blood center cancels the next appointment of the donor (who's unit will not be used) before they donate another unit.
   
   
2. A blood center in Southern California commented that this is a "can of worms" and it is very unlikely that consensus will be reached. There is no community standard; "we all hold dear our own particular viewpoint and will not be swayed by reason, nor, in my case, law. We are of the school that does not release, nor draw (with rare exception - in our case, our local VA.) donors truly positive for HCV, HIV or HBV (we are not concerned about HTLV). We feel strongly that the risk to the unsuspecting patient who would get the wrong unit outweighs the risk to the infected recipient of harm befalling him/her by getting an extremely safe community allogeneic unit. Should we allow someone with active TB to sit in a public place without a mask or do we care that they might infect a nearby stranger? Why then, should we interpret the ADA as saying we have to put at risk innocent patients in order to prevent a theoretical (and vanishingly small) risk to the patient with a known infectious disease."
   
   
3. A university-associated public hospital in Northern California decided to not transfuse HIV, HBsAg, HCV and HTLV confirmed positive autologous units. This hospital considered the ADA legislation but felt that the case before the supreme court (an HIV positive patient who was denied dental work at the dentist's office) does not readily apply to the transfusion situation and does not address the safety of "innocent bystanders" i.e., hospital patients who may be at an increased risk if infectious autologous units are being transfused. Key arguments in the discussions were a) despite rigorous policies a low residual risk of erroneous administration of autologous blood to a nonintended patient seems unavoidable (approx. 1:60,000 - 1:20,000 in several published studies) - importantly, the risk seems to be less so in the Blood Bank than in patients areas, for example the OR, b) as a level one trauma center and teaching hospital, where emergency and massive transfusions are commonplace, the risk of unit misadministration may theoretically be even higher and anesthesiologists and trauma surgeons voiced concern over rare bursting of pressure transfused units which could shower staff with blood, c) even though the risk that a misadminstrated autologous unit is also infectious is lower than the risk of transfusing a random unit in error, the risk of viral transmission for specific patients who receive blood during surgery at a time when infectious autologous units are present in the OR area may still be higher than the current infectious risk from allogeneic units, a situation which we think is not acceptable, d) the benefits of receiving autologous blood with regard to prevention of infectious disease transmission is much lower today than in the past and the benefit of avoiding immunosuppressive effects by transfusing autologous blood is controversial; moreover in this hospital's patient population the majority of autologous donor-patients required allogeneic as well as autologous blood, e) even though HCV and HTLV positive units pose less of a threat than HIV or HBsAg positive units, this institution felt from both a standpoint of transfusion safety and fairness to autologous donor-patients that none of these units should be accepted into the hospital. The blood banker reporting for this institution realizes that this is a controversial and highly charged topic but he believes "blind" application of the ADA provisions to the transfusion setting is problematic. Each institution ought to have the freedom to decide if they are comfortable with the risk benefit analysis for transfusing infectious auto units in their facility or not.
   
   
4. An institution in North Carolina reports that it discards confirmed HCV, HIV, and HBV, but not HTLV. If confirmatory testing is not available before surgery, the units are released with the surgeon's consent and appropriately labeled. This institution is also (by coincidence) bringing this issue to its medical board. About two years ago, the medical board was informed of the ADA concerns, but it was elected not to change the policy at that time. The institution has had some surgeons concerned about the discard policy for their individual patients. The blood banker reporting for this institution believes that cogent arguments can be made on both sides of this issue. While mistranfusion is on the order of 1:19,000 units, it would be much rarer to have the unit be autologous and HIV (or HCV, HBV) concurrently. However, when this does occur, it's a total disaster, analogous to a plane crash. This has to be weighed against the medical benefits of autologous blood in these patients, as well as the legal risks of not making autologous blood available.
   
   
5. A pathologist in Texas reports that he believes two very large Houston hospitals have a policy of keeping no seropositive autologous units in the blood bank. In this pathologist's own community hospital (in Richmond, Texas), the institution is currently formulating its own policy, but the pathologist thinks that his institution will go along with the 'big guys'. As for the ADA, the pathologist will probably just ignore the issue until such time that someone complains and then try to finesse it somehow. The pathologist believes that it is probably impossible to run any institution of any type without violating some provision of the ADA.
   
   
6. A university medical center in Southern California, at which both private and public hospitals are located, has a standardized center wide policy to accept only autologous blood that is not considered to be infectious. This center will accept autologous blood that tests positive for anti-HBcore, ALT, and syphilis serologies, as such autologous units are unlikely to be infected. However, all autologous units that are confirmed positive for HIV, HBV, HCV and HTLV are not accepted.
   
   
7. An academic hospital in North Carolina will not accept or store units which are positive for hepatitis or HIV markers. This hospital will store autologous units with high ALT.

The following comments favor storing and transfusing infected autologous units:

8. An institution in Denver reported that while they do not discount the risk of a unit being transfused to the wrong patient, they are far more concerned about the incremental risk to all the health care workers who have direct contact with such an autologous donor. They will continue to collect a donor who has a positive infectious disease marker, but it is their policy to notify the donor/patient's physician after the first unit has been tested and discuss whether to continue drawing the individual for the requested number of units. The patient's physician has the responsibility to notify the operating room team in advance that they will be handling units ( and the patient, for that matter) which are positive for an infectious disease marker. This institution feels that this is prudent despite the expectation that everyone will use standard precautions, especially since the units are labeled in a manner that would cause concern to those handling them.
   
   
9. At a cancer institute in Southern California, they accept and transfuse the autologous units described because of the ADA legislation. Prior to the ADA legislation, they did not accept such units. Their decision was in part based on the information provided by the AABB in Association Bulletin #98-5. (You must be an AABB member to access this page). To help minimize the potential for mistransfusion errors, they also implemented a policy for these units requiring that they be issued only for immediate transfusion, and not allow the units to be stored in the satellite refrigerator in surgery.
   
   
10. Another hospital in Southern California reported that it accepts all autologous donations, regardless of test results (all units must be tested to be received -- the institution does not accept "untested" units) but the unit will be acceptable (for that recipient only) regardless of the results of confirmatory testing, for any test. Physician notification of abnormal test results must occur (in accordance with AABB Standards). Additionally, for units that are confirmed positive for anti-HIV, HBsAg and HIV p24 antigen, the patient's physician must provide documentation of notification / request to use the product (in accordance with FDA memoranda 3/15/89 and 8/8/95).
    
    
11. A large blood center in the Southwestern U.S. reported that since they are at the collection/distribution end they don't defer autologous donors who are known to be positive for viral markers. They follow special procedures during collection from high risk donors (defined as those with confirmed positive HBsAg, anti-HIV and/or HIV p24 Ag). Donors and their physicians are notified of positive test results. Collection Centers maintain letters from hospitals verifying which units with positive viral marker(s) will or will not be accepted. .FDA requirements are included in 2 memoranda (3/15/89 and 2/12/90). The blood banker reporting on this center's experience says that the majority of hospitals accept most positive units including HIV & HBsAg units. It has been suggested that autologous blood transfusion would be beneficial for patients with HIV infection, since they would avoid the immunomodulatory effect of allogeneic (WBC) blood and possible HIV and CMV viral activation (VATS study). Recent study by the same group found no evidence of HIV, CMV, or cytokine activation following allogeneic blood transfusion in patients with advanced HIV infection (JAMA 2001; 285:1592-1601).
    
    
12. A large south central U.S. blood center follows the policy of their individual hospitals. This center is often asked to provide informational materials on this issue, but they try to take a neutral position. There has always had a mixed practice among their hospitals, some will take positive units and others never do. But in the last couple of years it seems that more hospitals are willing to take positive autologous units, including confirmed
    positive HIV autologous units. They say it is because of the ADA ruling and discussions within their own risk management department, and also because of shortages within the community blood supply. They argue, how can you tell a patient he/she can't use his/her autologous unit when elective surgeries are being cancelled/postponed for lack of blood?
    
    
13. An institution in Central California accepts, stores and transfuses infected autologous units. The process starts earlier with their donor center, which is also located in Central California. They notify the ordering physician of any positive markers and ask if he will accept the units. Some physicians refuse, but the majority ok the continuation of the donations. The infected units arrive tagged from the donor center in a plastic bag. This helps to protect the refrigerator in the event that there is a leak (however unlikely the possibility). This hospital reports that they have never transfused an autologous unit to the wrong person. The additional tag and baggy flag the unit, so that it is handled with care.
    
    
14. A Medical Director of a blood center in Northern California reported that almost all of the hospitals that her center supplies (San Francisco Bay area) will accept autologous units from patients with such viral infections. There was an initial move away from accepting these units but after the passage of the ADA legislation most facilities reconsidered their decisions. Even those hospitals who retain a non-acceptance policy end up taking the unit(s) if it has already been drawn. It seems important to put the risk in perspective. According to this medical director, if you give blood from a donor who is group A and the patient is group O the patient might have an immediate fatal transfusion reaction. No one would even think of suggesting that we should not put group A units in our blood bank refrigerators for fear that there might be a clerical error. In view of the immune effects of allogeneic transfusion one might argue that those with significant viral infections who are well enough to donate their own blood in advance of elective surgery should be encouraged to do so. It was suggested that the e-network might be interested in reading a discussion of the two sides of this issue in the AABB Monograph "Component Selection: Polemics and Politics" from 1996. One chapter, authored by Dr. Cherie Evans, was entitled "HIV Infected Patients in Autologous Blood Programs' (pro) and the other chapter, authored by Dr. S. Breanndan Moore, was entitled "Should Patients Infected with HIV or Hepatitis Donate Autologous Blood" (con).
    
    
15. A large blood supplier (which ships more blood than any other collection center in California) reported that they release autologous units that are positive for HIV, HBV, HCV, and HTLV to transfusion services. For HIV and HBV, the transfusion service must send written confirmation that they wish to have the unit shipped to them before they will release the unit for shipment. Units with HCV and/or HTLV repeat reactivity or positively are shipped automatically to the transfusion services (with the exception of a very few transfusion services who have indicated that they do not want certain autologous units with either repeat reactive or positive markers shipped to them).
    
    (Editor's NOTE: At my medical complex are three separate transfusion services (LAC+USC Medical Center, USC Kenneth Norris Cancer Hospital and USC University Hospital) all of which refuse to accept infected autologous units from this supplier, for reasons described in the first set of replies).
    
    
16. And finally, a word from the AABB: "In relation to a recent inquiry to the CBBS e-network regarding institutions' practices for accepting HIV positive units, individuals are encouraged to review an Association Bulletin published by the American Association of Blood Banks entitled 'The ADA, HIV and Autologous Blood Donation.' As described in this bulletin, in 1998, the Supreme Court ruled that an individual who is HIV positive has a protected disability under the Americans with Disabilities Act (ADA). Although no court has yet addressed the specific issue of blood donations from an HIV positive individual, it is likely that a court would hold that an institution that offers autologous blood donation and transfusion services cannot deny such services to an HIV positive individual under the ADA. It is also likely that courts would apply similar reasoning to cases involving patients diagnosed with other infectious diseases, such as HCV. The AABB Association Bulletin can be accessed on www.aabb.org, in the Members Section, under Resource Center > Publications > Association Bulletins > Association Bulletin 98-5. If individuals have questions about this Association Bulletin or this issue, please contact me by e-mail or phone (301/215-6554). Theresa L. Wiegmann, General Counsel, American Association of Blood Banks."

ADDENDA June 7, 2001

17. At my institution, we collect, process and transfuse autologous units regardless of their positive test results. We have collected autologous units from donors known to be confirmed positive for HIV. We test autologous units only if they are going to be frozen at the local blood center or shipped outside of our facility. Autologous units that will be used at our facility are not tested except for ABO/Rh and antibody screen.
    
    We segregate autologous units as much as possible. During processing and labeling, the units are kept on separate shelves. After the units are labeled and retyped, they are kept in a separate section of one refrigerator. The units are kept in this refrigerator until they are issued to the floor for transfusion.
    
    Units that are not tested for viral markers are labeled with a biohazard sticker and put in a pink zip lock bag.

ADDENDA June 12, 2001

18. Our facility does not accept autologous positive HIV and HBV blood back into the institution. We are worried about the Americans with Disabilities Act legislation, too. Could the transfusion of HIV, etc. positive autologous blood be approached medically as a less than optimal product for the patient to receive back into their body due to viral loads? There is the antecdotal story of the HIV-positive patient being refused autologous donation, getting an allogeneic transfusion and developing Hepatitis C from it. I'm sure there are many ethical issues involved and would love some definitive guidlines.

ADDENDA Aug. 3, 2005

19. 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

20. The Editor recommends review of the 2004 discussion: Policies on the use of autologous units that test positive for HIV, HBV and/or HCV.

21. 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."

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).

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

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