Transfusion-related acute lung injury secondary to biologically active mediators.

Transfusion-related acute lung injury is seen following the transfusion of blood components. The reported incidence is approximately 1 in 2000 transfusions. Clinically, it is similar to adult respiratory distress syndrome. The pathophysiology is unclear but has been attributed to HLA antibodies, granulocyte antibodies, and more recently to biologically active mediators in stored blood components. We report a case with laboratory evidence that supports the role of biologically active mediators in the pathogenesis of transfusion-related acute lung injury. To our knowledge, the case reported here is the first to use lipid extractions of patient samples to determine that lipid-priming activity was present at the time transfusion-related acute lung injury was identified clinically.

Policies and procedures related to weak D phenotype testing and Rh immune globulin administration. Results from supplementary questions to the Comprehensive Transfusion Medicine Survey of the College of American Pathologists.

OBJECTIVE: To determine and evaluate policies and procedures related to weak D phenotype testing and terminology and the administration of Rh immune globulin in selected clinical situations. Design, Setting, and Participants.-Institutions participating in the College of American Pathologists 1999 J-A Comprehensive Transfusion Medicine Survey program were asked to respond to a series of supplementary questions related to weak D phenotype testing and Rh immune globulin administration. More than 3500 institutions and transfusion services participated. RESULTS: Most supplementary questions elicited more than 3000 responses. Despite no clinical or regulatory mandate, 58. 2% of transfusion services routinely perform an antiglobulin test for the weak D phenotype in patients who test negative with anti-D reagents. Significant differences were found concerning the transfusion of blood components to patients with the weak D phenotype and the administration of Rh immune globulin to these individuals. At least one patient with the weak D phenotype with anti-D alloantibody formation was observed during a 12-month period by 31.8% of transfusion services. CONCLUSIONS: Significant variability concerning policies and procedures related to weak D typing and terminology was found in this survey. Transfusion of blood components to patients with the weak D phenotype and the administration of Rh immune globulin also demonstrated variations. Anti-D alloantibody formation by patients with the weak D phenotype may not be as rare as previously thought. Additional study related to the clinical significance of these results is warranted.

Use of an HBV-DNA hybridization assay in the evaluation of equivocal hepatitis B virus tests in solid organ donors.

CONTEXT: Serological markers for the hepatitis B virus are routinely used in the evaluation of potential organ donors. However, serological tests can be associated with significant false or equivocal results and may not be indicative of the true risk of hepatitis B infection. Studies have recently questioned the significance of an isolated hepatitis B core antibody test in evaluating the suitability of solid organs for transplantation. The ability to detect hepatitis B virus DNA may prove useful when the diagnosis of hepatitis B infection is in doubt. DESIGN: Serum samples from 16 donors with equivocal or positive hepatitis B core antibody and/or hepatitis B surface antigen serological screening tests were retrospectively tested for the presence of hepatitis B DNA. Any available follow-up data on the placement of organs from these donors was obtained. RESULTS: One of the 16 (6.3%) donors tested positive for the presence of hepatitis B DNA, but organs from this donor were not recovered or transplanted. Follow-up on 14 organs recovered and transplanted from 6 donors in this group did not show clinical and/or laboratory evidence of hepatitis B infection in the recipients. CONCLUSIONS: In our donor population, there was a low incidence (6.3%) of donors with equivocal or positive hepatitis B core antibody and/or hepatitis B surface antigen serological screening tests who subsequently demonstrated the presence of detectable hepatitis B DNA. Posttransplantation follow-up of the recipients of 14 recovered organs failed to demonstrate any cases of posttransplant hepatitis B infection.

Use of preoperative autologous blood donation in patients undergoing radical retropubic prostatectomy.

OBJECTIVES: To evaluate the appropriateness of autologous blood (AB) transfusion during radical retropubic prostatectomy in relation to the cardiopulmonary risk of the patient. METHODS: We reviewed the medical records of 100 patients with American Society of Anesthesiologists status I, II, or III who underwent radical retropubic prostatectomy under general or combined general and epidural anesthesia. All patients had donated 2 units (U) of autologous blood, received 0, 1, or 2 U of autologous blood perioperatively, and received no allogeneic blood. Patients were placed in three cardiopulmonary risk groups on the basis of risk factors or documented cardiopulmonary disease. The low-risk group was assigned a target discharge hematocrit of 24% or less; moderate-risk, 25% to 28%; and high-risk, 29% or greater. The appropriateness of transfusion was determined by whether patients' hematocrit was in their group's preassigned range at discharge. RESULTS: On the basis of discharge hematocrit, significantly more low-risk patients underwent inappropriate transfusion than moderate-risk (64% versus 26%, P = 0.006) or high-risk (64% versus 13%, P = 0.001) patients. Seventy-five AB units were discarded and at least 53 U were inappropriately transfused. We found an increase in the number of units of autologous blood transfused when a larger estimated blood loss was reported (P < 0.001). The estimated charge for the units discarded and inappropriately transfused exceeded $12,000. CONCLUSIONS: Sixty-four percent of autologous blood units were discarded or inappropriately transfused during radical retropubic prostatectomy. Transfusion of autologous blood was not governed by cardiopulmonary risk stratification. If the decision to transfuse had been based on cardiopulmonary risk factors instead of estimated blood loss, fewer patients would have received autologous blood.

Infectious disease testing related to organ and tissue transplantation: results from a national laboratory survey.

BACKGROUND: The purpose of this national survey in the United States was to determine laboratory practices and policies related to infectious disease testing of tissue and organ donors. METHODS: Supplementary questions were asked of the laboratories that subscribe to the College of American Pathologists' 1996 Donor Center (DC-B) and Viral Markers (W1-B and W2-B) surveys. Only the laboratories that perform infectious disease testing for the purposes of organ and tissue transplantation were asked to respond to the survey. RESULTS: A total of 1563 laboratories participated in the 1996 DC-B, W1-B, and W2-B surveys. A total of 203 (13.0%) laboratories indicated that infectious disease testing was performed for purposes of tissue and organ transplantation. The majority (81. 1%) of respondents were hospital-based laboratories or regional blood centers. Variances existed in policies regarding type of testing, turnaround times, maintenance of frozen samples, confirmatory testing of positive screening tests, and the reporting of results. CONCLUSIONS: Various policies and procedures are practiced by laboratories that perform infectious disease testing related to transplantation, and standard guidelines do not currently exist. More data is needed to assess the variability of infectious disease testing of organ donors, as well as the need for standard guidelines.

An examination of ethical issues raised in the pretreatment of normal volunteer granulocyte donors with granulocyte colony-stimulating factor.

OBJECTIVE: To explore some of the ethical issues surrounding the administration of granulocyte colony-stimulating factor (G-CSF) to healthy individuals for the purpose of retrieval of granulocytes. DESIGN: Review of the historical precedent of drug administration to normal blood donors and review of the literature concerning the side effects of G-CSF administration to healthy individuals, particularly as related to granulocyte collection. We identify and discuss some of the ethical questions regarding this issue. RESULTS: Although the short-term side effects of G-CSF use in normal donors are generally felt to be benign, little is known about the long-term side effects. Ethical questions regarding the administration of this drug to normal donors for the purpose of collecting large numbers of granulocytes include the following: Does the potential benefit to a patient/recipient justify the unknown risks to the medicated granulocyte donor? Who should act as an advocate for donors so that their best interests are protected? What is the role and quality of informed consent for donors undergoing G-CSF administration? Is monetary compensation appropriate for donors administered G-CSF as part of a research protocol? CONCLUSIONS: We recommend the establishment of a donor registry to collect the needed data on the side effects of G-CSF on normal donors. Until adequate data are collected, the use of G-CSF and similar agents in normal donors should be regarded as experimental and subject to review by institutional review boards.

Immunogenicity of hepatitis A vaccine in decompensated liver disease.

OBJECTIVE: Hepatitis A can cause decompensation and death in patients with previous liver injury. The hepatitis A vaccine is recommended for patients with chronic liver disease. The aim of this study was to screen, immunize, and measure the safety and antibody response of the hepatitis A vaccine in liver failure and liver transplant patients. METHODS: This was a prospective immunization trial at a referral center for liver disease and liver transplantation. A total of 193 patients with severe chronic liver disease were screened and 24 patients were vaccinated. Sixteen end stage liver disease patients were compared with eight liver transplant patients. Hepatitis A vaccinations using 1440 ELISA units were given at 0 and 2 months. Serum hepatitis A antibody titers were measured after each vaccine dose. An antibody response > or = 33 mIU/ml was considered protective. RESULTS: Screening seropositive rate was 70 of 193 (36%) and 24 patients were available for vaccination. The median antibody titer was markedly lower in liver transplant patients, 0.0 mIU/ml compared to liver failure patients 34.7 mIU/ml (p < 0.001). Liver transplant recipients did not respond to the vaccine (0 of eight patients) compared with seven of 14 liver failure patients (seroconversion rate 50%, p = 0.02). CONCLUSIONS: Liver failure significantly reduces the antibody response to hepatitis A vaccine, and liver transplant recipients were unable to respond to the vaccine. Although this study was small, immunization should be considered early for susceptible patients with chronic liver disease because the development of liver failure may blunt the immunogenicity of the vaccine.

Autologous blood donation by patients who have undergone solid organ transplantation.

Autologous blood donation before elective surgery is generally believed to be a safe procedure for patients with a variety of underlying medical conditions, but the accumulation of additional data continues to define its safety in unique patient groups. Patients who have received a solid organ transplant may also undergo various elective surgical procedures after transplantation, and the question of safety of autologous blood donation for these patients is raised. In one hospital-based blood collection program, we identified 4 patients who had received solid organ transplants and subsequently made autologous blood donations for elective operations unrelated to the transplantation. Two patients had received heart transplants and 2 received liver transplants. A total of 10 autologous donations were made by these 4 patients without adverse effects or complications. A low hemoglobin concentration was the only reason for temporary deferral from autologous donation. Despite having complicated clinical situations, recipients of solid organ transplants can safely donate autologous blood and should not be automatically excluded from making such donations.

Adverse reactions associated with autologous blood transfusion: evaluation and incidence at a large academic hospital.

BACKGROUND: It is acknowledged that autologous blood is the safest for the patient to receive. However, it is generally not appreciated that transfusion reactions to autologous blood may occur, despite the fact that it is the patient's own blood. STUDY DESIGN AND METHODS: A retrospective review of all transfusion reactions reported to a hospital transfusion service from 1991 through 1996 was performed, and all reactions to autologous blood were further investigated. RESULTS: Reported adverse reactions to autologous blood composed 2.1 percent of all transfusion reactions investigated in the hospital, involving 0.16 percent (15/9,353) of all transfused preoperatively donated autologous red cell units and 0.027 percent (5/18,506) of all intraoperatively salvaged units. Further investigation revealed that 60 percent (12/20) of these adverse reactions were felt to be clinically important and directly attributable to the autologous blood transfusion. Adverse reactions included febrile nonhemolytic (5) and allergic (4) reactions, an acute hemolytic transfusion reaction secondary to a clerical error (1 intraoperatively salvaged unit), and other nonsignificant adverse reactions (2). Eight adverse reactions were determined these reactions to be unrelated to the autologous transfusion. CONCLUSION: Despite the fact that the blood given is the patient's own blood, transfusion reactions to autologous blood do occur. As it is for allogeneic transfusion, any suspected adverse reaction to autologous blood transfusion should be investigated.

An overview of immune hemolytic anemias.

Often patients with immune hemolytic anemias present with symptoms that are common in anemia of any cause. In the different types of immune hemolytic anemia, red blood cells are destroyed by processes mediated by antibodies. This article reviews the pathophysiology, diagnosis, and treatment of this group of diseases.

The transfusion service is an integral and important component of the hospital and should not be outsourced.

Hospitals are under increased pressure to decrease operating costs. Hospital-based laboratories, blood banks (transfusion services), increasingly face the potential of being outsourced as hospitals try to survive the current waves of managed care. A number of complicated and unique services are provided by the hospital-based transfusion service and physician. Clinical consultation, complicated immunohematological procedures, apheresis, participation in a complex array of patient-care services, clinical research, ever increasing regulatory issues, and quality assurance activities are only a few of the challenges in today's transfusion medicine environment. This paper will focus on the hospital-based transfusion service, and the transfusion medicine physician, and present arguments as to why this service should remain close to the patient's bedside and not be outsourced.

Results of a survey of infectious disease testing practices by organ procurement organizations in the United States.

BACKGROUND: Information related to infectious disease testing policies and practices of organ procurement organizations in the United States does not currently exist. METHODS: A total of 63 organ procurement organizations in the United States were surveyed during May 1996. Participants responded to a detailed questionnaire concerning infectious disease tests performed for tissue and solid organ donors and policies related to the reporting and notification of positive test results. RESULTS: The response rate was 77.8%. The majority of testing is performed by hospital laboratories with an expected turnaround time of 5 hr or less by 71% of organ procurement organizations. Almost all routinely perform screening tests for human immunodeficiency virus, hepatitis C virus, cytomegalovirus, syphilis, human T lymphocyte virus I, and hepatitis B surface antigen. Other tests are performed with greater variability. Although the majority of organ procurement organizations perform confirmatory tests when screening tests are positive, 35% do not perform confirmatory testing or do so only sporadically. There are a wide range of policies concerning the subsequent reporting of positive infectious disease tests and to whom results should be reported. CONCLUSIONS: Infectious disease testing policies of organ procurement organizations, particularly for solid organs, demonstrate variability in interpretation and perceived significance of positive test results, the initiation or need for reflex and confirmatory testing, the reporting of positive results, and to whom positive test results should be reported. There is a need for a consistent national policy for appropriate infectious disease testing and reporting of results.

An evaluation of the need for shared blood donor deferral registries.

OBJECTIVE: This study examined the frequency with which allogeneic, volunteer blood donors who had been deferred from donation at one blood collection facility donated, or attempted to donate, at a second blood collection facility. METHODS: The blood donor computer files of two local blood collection facilities were-combined and matched donors on the donor deferral registry of each blood collection facility were identified. RESULTS: Of 26,300 donors in the hospital-based blood bank file, 6732 (25.6%) were matched to the community blood center donor file (active donor base approximately 275,000). Matched donors on the donor deferral registry at each blood collection facility numbered 427 (6.3% of total matched donors). A total of 103 evaluable donors (1.5% of total, or 24.1% of deferred, matched donors) had been deferred at one blood collection facility and then later donated, or attempted donation, at the other blood collection facility. Of these 103, 51 were allogeneic donors who had been notified of their deferral status and should not have subsequently attempted blood donation. Thirty-two donors on the donor deferral registry of one blood collection facility made donations at the second blood collection facility which entered the general blood inventory. CONCLUSION: Shared donor deferral registries may be valuable at the local or regional level to prevent deferred blood donors from donating at other blood collection facilities. Whether or not a national donor deferral registry would be efficacious remains to be proven and deserves further study.

Fellowship training programs in blood banking and transfusion medicine: results of a national survey.

This report details the results of a 1995 survey of the 40 fellowship training programs in blood banking and transfusion medicine in the United States approved by the Accreditation Council for Graduate Medical Education. Fellows primarily enter transfusion medicine training after completing a pathology residency, and are subsequently employed in an academic or university setting, or a blood donor center. Program directors indicated that either the current level, or fewer, transfusion medicine specialists will be needed in the future. The educational content of fellowship training was examined, as well as aspects of proficiency and competency in several areas. Research is an important part of most fellowship programs, and a majority of program directors felt that some formal training in clinical medicine should be a part of fellowship training in transfusion medicine. The information obtained from this survey should be helpful to both fellowship applicants and program directors in delineating important aspects of fellowship training in blood banking and transfusion medicine.

Preoperative autologous blood donation: clinical, economic, and ethical issues.

Many patients are donating their own blood before surgery to avoid blood-borne infections, often on the advice of their physicians. But autologous blood transfusion, while safer than allogeneic transfusion, is not completely risk-free. It is also expensive, its benefits are difficult to assess, and its increasing popularity raises many difficult ethical issues, such as whether the benefit of allogeneic transfusion supports its additional expense. Record-keeping, collection, and transfusion errors are occasional risks of autologous transfusions. In addition, risks associated with blood donation, from mild dizziness to precipitation of angina, should be considered when high-risk patients are referred for autologous collection. Only approximately half of autologous units collected are actually used, and the cost per quality-adjusted year of life saved may be as high as $1 million, depending on the type of surgical procedure. Although recombinant human erythropoietin can stimulate red blood cell production before autologous donation and decrease the need for transfusion, it is not clear whether this strategy, which can cost thousands of dollars per patient, will be cost-effective. Perioperative hemodilution may become an important component in efforts to reduce patient exposure to allogeneic blood, but its use remains controversial.

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.

OBJECTIVE: The confidential unit exclusion (CUE) is a mechanism for allogeneic blood donors to confidentially indicate whether they feel their blood is safe for transfusion to others. The purpose of this national survey was to determine the extent of use of the CUE procedure and its related policies. DESIGN: Supplementary questions related to the use of the CUE were asked of those 1994 DC-C, W1-C, and W2-C College of American Pathologists survey subscribers who collect allogeneic blood for transfusion. SETTING: National survey. PARTICIPANTS: Blood collection facilities who collect allogeneic blood components. MAIN OUTCOME MEASURES: Survey responses. RESULTS: There were a total of 2966 total participants in the 1994 DC-C, W1-C, and W2-C surveys. A potential total of 444 participants indicated that they collected allogeneic blood and were eligible to participate in the CUE survey. A variety of approaches are used concerning donor deferral, reinstatement, and follow-up in the use of the CUE. Documentation and donor counseling issues also show variation. CONCLUSIONS: Different approaches and procedures have been developed by collection facilities to address issues related to the use of the CUE. More data on the efficacy and cost-effectiveness of the CUE are needed.