Transmission of Hepatitis C Virus From Organ Donors Despite Nucleic Acid Test Screening.

Nucleic acid testing (NAT) for hepatitis C virus (HCV) is recommended for screening of organ donors, yet not all donor infections may be detected. We describe three US clusters of HCV transmission from donors at increased risk for HCV infection. Donor's and recipients' medical records were reviewed. Newly infected recipients were interviewed. Donor-derived HCV infection was considered when infection was newly detected after transplantation in recipients of organs from increased risk donors. Stored donor sera and tissue samples were tested for HCV RNA with high-sensitivity quantitative PCR. Posttransplant and pretransplant recipient sera were tested for HCV RNA. Quasispecies analysis of hypervariable region-1 was used to establish genetic relatedness of recipient HCV variants. Each donor had evidence of injection drug use preceding death. Of 12 recipients, 8 were HCV-infected-6 were newly diagnosed posttransplant. HCV RNA was retrospectively detected in stored samples from donor immunologic tissue collected at organ procurement. Phylogenetic analysis showed two clusters of closely related HCV variants from recipients. These investigations identified the first known HCV transmissions from increased risk organ donors with negative NAT screening, indicating very recent donor infection. Recipient informed consent and posttransplant screening for blood-borne pathogens are essential when considering increased risk donors.

Transmission of methicillin-resistant Staphylococcus aureus infection through solid organ transplantation: confirmation via whole genome sequencing.

We describe two cases of donor-derived methicillin-resistant Staphylococcus aureus (MRSA) bacteremia that developed after transplantation of organs from a common donor who died from acute MRSA endocarditis. Both recipients developed recurrent MRSA infection despite appropriate antibiotic therapy, and required prolonged hospitalization and hospital readmission. Comparison of S. aureus whole genome sequence of DNA extracted from fixed donor tissue and recipients' isolates confirmed donor-derived transmission. Current guidelines emphasize the risk posed by donors with bacteremia from multidrug-resistant organisms. This investigation suggests that, particularly in the setting of donor endocarditis, even a standard course of prophylactic antibiotics may not be sufficient to prevent donor-derived infection.

Excerpt from PHS guideline for reducing HIV, HBV and HCV transmission through organ transplantation.

The intent of the PHS guideline is to improve organ transplant recipient outcomes by reducing the risk of unexpected HIV, HBV and HCV transmission, while preserving the availability of high-quality organs. An evidence-based approach was used to identify the most relevant studies and reports on which to formulate the recommendations. This excerpt from the guideline comprises (1) the executive summary; (2) 12 criteria for assessment of risk factors for recent HIV, HBV and HCV infection; (3) 34 recommendations on risk assessment (screening) of living and deceased donors; testing of living and deceased donors; informed consent discussion with transplant candidates; testing of recipients pre- and posttransplant; collection and/or storage of donor and recipient specimens; and tracking and reporting of HIV, HBV and HCV; and (4) 20 recommendations for further study. For the PHS guideline in its entirety, including the background, methodology and primary evidence underlying the recommendations, refer to the source document in Public Health Reports, accessible at http://www.publichealthreports.org/issuecontents.cfm?Volume=128&Issue=4. For more in-depth information on the evidence base, including tables of all study-level data, refer to Solid Organ Transplantation and the Probability of Transmitting HIV, HBV or HCV: A Systematic Review to Support an Evidence-Based Guideline, accessible at http://stacks.cdc.gov/view/cdc/12164/.

Communication gaps for solid organ transplant-transmitted infections among infectious disease physicians: an Emerging Infections Network survey.

Infectious disease (ID) physicians were surveyed concerning knowledge and management of potential transplant-transmitted infections (TTIs). On the basis of cumulative responses to 4 questions that assessed solid organ transplant-related clinical exposures and experience, respondents were divided into 3 groups: most, some, or little transplant experience. Rapid access to donor data was identified as the most important factor when evaluating a potential TTI. Despite varying experience in transplant infections, ID physicians are frequently asked for opinions regarding donor suitability and TTI management. Improved ID physician access to donor information and educational resources will allow more optimal management of potential TTIs.

Current practices and evaluation of screening solid organ donors for West Nile virus.

The first cases of West Nile virus (WNV) transmitted through solid organ transplantation (SOT) were identified in 2002. Subsequently, 5 additional clusters have been reported to public health officials in the United States. Based upon a limited number of known cases, patients who acquire WNV from infected donor organs might be at higher risk for severe neurologic disease and death, compared with patients infected through mosquito bites. In response, some organ procurement organizations (OPOs) have instituted pre-transplant screening of organ donors for WNV infection. We evaluated the current practices, concerns, and challenges related to screening organ donors for WNV in the United States by reviewing the relevant medical literature and interviewing key stakeholders. Screening organ donors for WNV is not required by national policy. In 2008, 11 (19%) of 58 OPOs performed WNV screening using nucleic acid amplification testing (NAT). These OPOs differ in their screening strategies, NAT performed, and logistical challenges. Concerns of delays in receiving NAT results before transplant and potential false-positive results leading to organ wasting are limitations to more widespread screening. Furthermore, it is unknown if WNV screening practices decrease SOT-related morbidity and mortality, or if screening is cost-effective. Additional data are needed to assess and improve transplant outcomes related to WNV.

Estimated risk of human immunodeficiency virus and hepatitis C virus infection among potential organ donors from 17 organ procurement organizations in the United States.

To prevent unintentional transmission of bloodborne pathogens through organ transplantation, organ procurement organizations (OPOs) screen potential donors by serologic testing to identify human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infection. Newly acquired infection, however, may be undetectable by serologic testing. Our objective was to estimate the incidence of undetected infection among potential organ donors and to assess the significance of risk reductions conferred by nucleic acid testing (NAT) versus serology alone. We calculated prevalence of HIV and HCV-stratified by OPO risk designation-in 13,667 potential organ donors managed by 17 OPOs from 1/1/2004 to 7/1/2008. We calculated incidence of undetected infection using the incidence-window period approach. The prevalence of HIV was 0.10% for normal risk potential donors and 0.50% for high risk potential donors; HCV prevalence was 3.45% and 18.20%, respectively. For HIV, the estimated incidence of undetected infection by serologic screening was 1 in 50,000 for normal risk potential donors and 1 in 11,000 for high risk potential donors; for HCV, undetected incidence by serologic screening was 1 in 5000 and 1 in 1000, respectively. Projected estimates of undetected infection with NAT screening versus serology alone suggest that NAT screening could significantly reduce the rate of undetected HCV for all donor risk strata.

Transmission of human immunodeficiency virus and hepatitis C virus from an organ donor to four transplant recipients.

In 2007, a previously uninfected kidney transplant recipient tested positive for human immunodeficiency virus type 1 (HIV) and hepatitis C virus (HCV) infection. Clinical information of the organ donor and the recipients was collected by medical record review. Sera from recipients and donor were tested for serologic and nucleic acid-based markers of HIV and HCV infection, and isolates were compared for genetic relatedness. Routine donor serologic screening for HIV and HCV infection was negative; the donor's only known risk factor for HIV was having sex with another man. Four organs (two kidneys, liver and heart) were transplanted to four recipients. Nucleic acid testing (NAT) of donor sera and posttransplant sera from all recipients were positive for HIV and HCV. HIV nucleotide sequences were indistinguishable between the donor and four recipients, and HCV subgenomic sequences clustered closely together. Two patients subsequently died and the transplanted organs failed in the other two patients. This is the first recognized cotransmission of HIV and HCV from an organ donor to transplant recipients. Routine posttransplant HIV and HCV serological testing and NAT of recipients of organs from donors with suspected risk factors should be considered as routine practice.

Donor-derived disease transmission events in the United States: data reviewed by the OPTN/UNOS Disease Transmission Advisory Committee.

Donor-derived disease transmission is increasingly recognized as a source of morbidity and mortality among transplant recipients. Policy 4.7 of the Organ Procurement and Transplantation Network (OPTN) currently requires reporting of donor-derived events. All potential donor-derived transmission events (PDDTE) reported to OPTN/UNOS were reviewed by the Disease Transmission Advisory Committee (DTAC). Summary data from January 1, 2005-December 31, 2007, were prepared for presentation. Reports of PDDTE have increased from 7 in 2005, the first full year data were collected, to 60 in 2006 and to 97 in 2007. More detailed information is available for 2007; a classification system for determining likelihood of donor-derived transmission was utilized. In 2007, there were four proven and one possible donor-derived malignancy transmissions and four proven, two probable and six possible donor-derived infectious diseases transmissions. There were nine reported recipient deaths attributable to proven donor transmissions events arising from eight donors during 2007. Although recognized transmission events resulted in significant morbidity and mortality, transmission was reported in only 0.96% of deceased donor donations overall. Improved reporting, through enhanced recognition and communication, will be critical to better estimate the transmission risk of infection and malignancy through organ transplantation.

A multistate cluster of red blood cell transfusion reactions associated with use of a leucocyte reduction filter.

In 2000, the American Red Cross (ARC) received reports of unusual transfusion reactions of unknown aetiology among patients receiving leucocyte-reduced (LR) red blood cell (RBC) units in multiple distribution regions. We evaluated potential risk factors of reactions among patients who received LR-RBC transfusions. A case-patient was defined as any patient with onset of back pain while receiving an LR-RBC transfusion from 1 January to 25 May 2000. Controls were chosen randomly and selected in a 1:3 case : control ratio from healthcare facilities in which case-patients were transfused. Product-specific risk factors of reactions were further determined through nested case-control study, procedural review of blood collection facility and quality-control-testing record review of product processing. Reaction incidence rates were determined through ARC blood product distribution data by region of blood collection and processing. There were 29 reactions detected in patients who received transfusions in 13 healthcare facilities in five states. Eighteen case-patients and 78 controls were included in the case-control study. In univariate analysis, case-patients were more likely than controls to have a haematologic malignancy, to have received the transfusion as an outpatient, to have received an RBC transfusion within the previous 3 months, to have received medication used to prevent reactions or to diminish their intensity upon transfusion (i.e. premedication) or to have received LR-RBC units prepared with the HemaSure r\LS System(HS) rather than two other filters used. In multivariate analysis limited to recipients of HS-filtered RBC units, transfusion premedication [adjusted odds ratio (AOR) = 7; 95% confidence interval (CI) 1.4-37; P = 0.02] and transfusion as an outpatient (AOR = 5; 95% CI 1.1-20; P = 0.03) were independently associated with reactions. The rate of reported transfusion reactions was 2.0 reactions per 10 000 RBC units distributed. A multistate cluster of transfusion reactions was significantly associated with leucocyte filtration of RBC units prepared with a specific product, the HS filter. The reactions also were independently associated with premedication and transfusion as an outpatient; these may be surrogates for an increased risk of reaction or for greater likelihood of detection. The mechanism for these reactions has not been elucidated. This cluster of reactions underscores the importance of surveillance efforts to detect adverse events after transfusion, particularly when new methods to modify blood products are introduced.

Rapid evaluation of risk of white particulate matter in blood components by a statewide survey of transfusion reactions.

BACKGROUND: In January 2003, white particulate matter (WPM) was detected in blood components. Because the composition and cause of WPM was not understood at that time, there was uncertainty about whether WPM could endanger patient safety. To investigate possible adverse patient events associated with WPM, transfusion reaction rates were examined. STUDY DESIGN AND METHODS: A questionnaire was distributed to Georgia medical centers. Data collected included the number of components transfused and reported adverse reactions by component type from January 2002 through January 2003, and date, reaction type, and blood supplier for events in January 2003. RESULTS: Of 124 transfusion services contacted, 108 (87%) responded. During the survey period, there were 1213 reported transfusion reactions and 528,412 units transfused, or 2.3 reactions per 1000 units transfused; for RBCs, 2.4 (range, 1.8-3.1); plasma, 1.5 (range, 0.6-3.5); and PLTs, 3.4 (2.1-5.4) per 1000 units. Transfusion reaction rates by component for January 2003 did not differ significantly from the rate for January 2002 or for the calendar year. The 86 reported reactions that occurred in January 2003 were attributed to bacterial contamination (n = 2, 2.3%), other febrile nonhemolytic (n = 49, 57.0%), allergic (n = 14, 16.3%), and "other" reactions (n = 21, 24.4%); the proportions of reaction types did not differ significantly during the month. CONCLUSION: No overall changes in reported adverse reaction rates occurred over the survey period or in the proportion of reaction types during January 2003 when WPM was detected. Statewide surveillance of transfusion reactions could be useful to evaluate potential threats to blood safety.

Control of vancomycin-resistant enterococcus in health care facilities in a region.

BACKGROUND: In late 1996, vancomycin-resistant enterococci were first detected in the Siouxland region of Iowa, Nebraska, and South Dakota. A task force was created, and in 1997 the assistance of the Centers for Disease Control and Prevention was sought in assessing the prevalence of vancomycin-resistant enterococci in the region's facilities and implementing recommendations for screening, infection control, and education at all 32 health care facilities in the region. METHODS: The infection-control intervention was evaluated in October 1998 and October 1999. We performed point-prevalence surveys, conducted a case-control study of gastrointestinal colonization with vancomycin-resistant enterococci, and compared infection-control practices and screening policies for vancomycin-resistant enterococci at the acute care and long-term care facilities in the Siouxland region. RESULTS: Perianal-swab samples were obtained from 1954 of 2196 eligible patients (89 percent) in 1998 and 1820 of 2049 eligible patients (89 percent) in 1999. The overall prevalence of vancomycin-resistant enterococci at 30 facilities that participated in all three years of the study decreased from 2.2 percent in 1997 to 1.4 percent in 1998 and to 0.5 percent in 1999 (P<0.001 by chi-square test for trend). The number of facilities that had had at least one patient with vancomycin-resistant enterococci declined from 15 in 1997 to 10 in 1998 to only 5 in 1999. At both acute care and long-term care facilities, the risk factors for colonization with vancomycin-resistant enterococci were prior hospitalization and treatment with antimicrobial agents. Most of the long-term care facilities screened for vancomycin-resistant enterococci (26 of 28 in 1998 [93 percent] and 23 of 25 in 1999 [92 percent]) and had infection-control policies to prevent the transmission of vancomycin-resistant enterococci (22 of 25 [88 percent] in 1999). All four acute care facilities had screening and infection-control policies for vancomycin-resistant enterococci in 1998 and 1999. CONCLUSIONS: An active infection-control intervention, which includes the obtaining of surveillance cultures and the isolation of infected patients, can reduce or eliminate the transmission of vancomycin-resistant enterococci in the health care facilities of a region.

Colonization of skilled-care facility residents with antimicrobial-resistant pathogens.

OBJECTIVES: To determine the frequency of and risk factors for colonization of skilled-care unit residents by several antimicrobial-resistant bacterial species, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococcus (VRE), or extended-spectrum-beta-lactamase-producing (ESBL-producing) (ceftazidime resistant) Klebsiella pneumoniae or Escherichia coli. DESIGN: Point-prevalence survey and medical record review. SETTING: The skilled-care units in one healthcare facility. PARTICIPANTS: 120 skilled-care unit residents. MEASUREMENTS: Colonization by each of the four antimicrobial-resistant pathogens during a point-prevalence survey, using rectal, nasal, gastrostomy-tube site, wound, and axillary cultures, June 1-3, 1998; 117 (98%) had at least one swab collected and 114 (95%) had a rectal swab collected. Demographic and clinical characteristics were evaluated as risk factors for colonization. All isolates were strain typed by pulsed-field gel electrophoresis of total genomic deoxyribonucleic acid. RESULTS: Of 117 participants, 50 (43%) were culture positive for > or =1 antimicrobial-resistant pathogen: MRSA (24%), ESBL-producing K. pneumoniae (18%) or E. coli (15%), and VRE (3.5%). Of 50 residents culture positive for any of these four antimicrobial-resistant species, 13 (26%) were colonized by more than one resistant species; only three (6%) were on contact-isolation precautions at the time of the prevalence survey. Risk factors for colonization varied by pathogen: total dependence on healthcare workers (HCWs) for activities of daily living (ADLs) and antimicrobial receipt for MRSA, total dependence on HCWs for ADLs for ESBL-producing K. pneumoniae, and antimicrobial receipt for VRE. No significant risk factors were identified for colonization by ESBL-producing E. coli. Among colonized patients, there was a limited number of strain types for MRSA (24 patients, 4 strain types) and ESBL-producing K. pneumoniae (21 patients, 3 strain types), and a high proportion of unique strain types for VRE (4 patients, 4 strain types) and FSBL-producing E. coli (17 patients, 10 strain types). CONCLUSION: A large unrecognized reservoir of skilled-care-unit residents was colonized by antimicrobial-resistant pathogens, and co-colonization by more than one target species was common. To prevent transmission of antimicrobial-resistant pathogens in long-term care facilities in which residents have high rates of colonization, infection-control strategies may need to be modified. Potential modifications include enhanced infection-control strategies, such as universal gloving for all or high-risk residents, or screening of high-risk residents, such as those with total dependence on HCWs for ADLs or recent antimicrobial receipt, and initiation of contact-isolation precautions for colonized residents.

Evaluation of a reporting system for bacterial contamination of blood components in the United States.

BACKGROUND: The transfusion of blood components contaminated with bacteria may have serious clinical consequences, but few data are available on the incidence of these events. A national effort to assess the frequency of blood component bacterial contamination associated with transfusion reaction (the BaCon Study) was initiated to better estimate their occurrence. STUDY DESIGN AND METHODS: Standard reporting criteria, data collection forms, and a standardized reporting protocol were developed in collaboration with the American Red Cross, AABB, and the Department of Defense. Episodes reported to the BaCon Study were compared with those reported to the FDA's national reporting systems to estimate the extent to which all serious reactions associated with bacterial contamination were captured. RESULTS: During the first 2 years, 38 episodes meeting study criteria were reported; 21 were laboratory-confirmed. The estimated proportion of episodes reported to the BaCon Study (i.e., completeness of coverage) was lower than that reported to the FDA during the same period (0.33 vs. 0.68), but the positive predictive value was higher (0.66 vs.0.28). CONCLUSION: Despite the complexity of obtaining reports from a large number of United States hospitals and transfusion centers, the feasibility and usefulness of the BaCon Study were shown. This study was the only national study in the United States to monitor adverse clinical events associated with bacterial contamination of blood components. By building on hospital-based reporting of transfusion-related adverse events, the BaCon Study serves as a model for the study of other complications associated with blood and blood components.

Transfusion-transmitted bacterial infection in the United States, 1998 through 2000.

BACKGROUND: Bacterial contamination of blood components can result in transfusion-transmitted infection, but the risk is not established. STUDY DESIGN AND METHODS: Suspected cases of transfusion-transmitted bacteremia were reported to the CDC by participating blood collection facilities and transfusion services affiliated with the American Red Cross, AABB, or Department of Defense blood programs from 1998 through 2000. A case was defined as any transfusion reaction meeting clinical criteria in which the same organism species was cultured from a blood component and from recipient blood, with the organism pair confirmed as identical by molecular typing. RESULTS: There were 34 cases and 9 deaths. The rate of transfusion-transmitted bacteremia (in events/million units) was 9.98 for single-donor platelets, 10.64 for pooled platelets, and 0.21 for RBC units; for fatal reactions, the rates were 1.94, 2.22, and 0.13, respectively. Patients at greatest risk for death received components containing gram-negative organisms (OR, 7.5; 95% CI, 1.3-64.2; p = 0.009). CONCLUSION: Bacterial contamination of blood is an important cause of transfusion-transmitted infection; infection risk from platelet transfusion is higher compared with that from RBCs, and, overall, the risk of infection from bacterial contamination now may exceed that from viral agents. Recipients of components containing gram-negative organisms are at highest risk for transfusion-related death. The results of this study may help direct efforts to improve transfusion-related patient safety.

Acute onset of decreased vision and hearing traced to hemodialysis treatment with aged dialyzers.

CONTEXT: A recent event in which 7 patients at 1 hospital developed decreased vision and hearing, conjunctivitis, headache, and other severe neurologic symptoms 7 to 24 hours after hemodialysis drew attention to the issue of the long-term integrity of dialysis machines and materials. OBJECTIVE: To determine the cause of the adverse reactions that occurred during this event. DESIGN, PATIENTS, AND SETTING: Retrospective cohort study of all 9 patients who received hemodialysis at hospital A on September 18, 1996, the day of the outbreak. A case-patient was defined as any hospital A patient with acute onset of decreased vision and hearing and conjunctivitis after dialysis on that day. Non-case-patients were all others who underwent dialysis at hospital A on that day but did not develop adverse reactions. In an attempt to reproduce the conditions of the event, cellulose acetate dialysis membranes of various ages were retrieved from other sources and tested for physical and chemical degradation, and degradation products were identified, characterized, and injected intravenously into rabbits. MAIN OUTCOME MEASURES: Clinical signs and symptoms, time to resolution of symptoms, mortality, and dialyzer type and age, for case- vs non-case-patients. RESULTS: Seven of the 9 patients met the case definition. In addition to diminished vision and hearing, conjunctivitis, and headache, some case-patients had blood leak alarm activation (n=6), confusion/lethargy (n=5), corneal opacification (n=4), cardiac arrest (n=2), or other neurologic signs and symptoms. One case-patient died during hospitalization after the event; 5 of 7 case-patients died within 13 months. Resolution of signs and symptoms varied but persisted more than 3 years or until death in 3 of the 6 patients who survived hospitalization. All case-patients but no non-case-patients were exposed to 11.5-year-old cellulose acetate dialyzers (all of these dialyzers were discarded by the hospital before our investigation). Laboratory investigation of field-retrieved 0- to 13.6-year-old dialyzers of similar type indicated significant chemical degradation in the older membranes. In vivo injection of extracts of membrane degradation products produced iritis and hemorrhages in rabbits' eyes. CONCLUSIONS: Severe patient injury was associated with exposure to aged cellulose acetate membranes of dialyzers, allowing cellulose acetate degradation products to enter the blood. Clinicians should be aware that aged cellulose acetate membranes may cause severe adverse reactions.

Association between mucositis severity and vancomycin-resistant enterococcal bloodstream infection in hospitalized cancer patients.

OBJECTIVE: To determine the role of mucositis severity in the development of vancomycin-resistant enterococcal (VRE) bloodstream infection (BSI). SETTING: A tertiary-care university medical center. PARTICIPANTS: Hematology-oncology-unit inpatients. DESIGN: Patients with VRE BSI (case-patients) were compared with VRE-colonized (control) patients from September 1994 through August 1997. Oral mucositis severity was recorded on the day of VRE BSI for case-patients and on hospital day 22 (median day of hospitalization of case-patient VRE BSI) for controls. There were 19 case-patients and 31 controls. RESULTS: In univariate analysis, case-patients were significantly more likely than controls to have a higher mucositis severity score, diarrhea, or a higher severity of illness score. In multivariate analysis, only mucositis remained as an independent risk factor, and increasing mucositis score was significantly associated with VRE BSI. CONCLUSIONS: Mucositis severity was independently associated with an increasing risk for VRE BSI. Interventions to alter mucositis severity may help to prevent VRE BSI in hospitalized cancer patients.

Regional dissemination of vancomycin-resistant enterococci resulting from interfacility transfer of colonized patients.

During early 1997, the Siouxland District Health Department (SDHD; Sioux City, IA) reported an increased incidence of vancomycin-resistant enterococcal (VRE) isolates at area health care facilities. To determine the prevalence and risk factors for colonization with VRE strains at 32 health care facilities in the SDHD region, a prevalence survey and case-control study were performed. Of 2266 patients and residents, 1934 (85%) participated, and 40 (2.1%) were positive for (gastrointestinal) VRE colonization. The prevalence of VRE isolates was significantly higher in acute care facilities (ACFs) than in long-term care facilities (LTCFs) (10/152 [6.6%] vs. 30/1782 [1.7%]; odds ratio [OR], 4.1; 95% confidence interval [CI], 1.8-9.0). LTCF case patients were significantly more likely than controls to have been inpatients at any ACF (19/30 vs. 12/66; OR, 8.0; 95% CI, 2.7-23.8). Of 40 VRE isolates, 34 (85%) were a related strain. The predominant strain was present in all 12 LTCFs that had at least 1 case patient in each facility. Soon after the introduction of VRE isolates into this region, dissemination to multiple LTCFs resulted from resident transfer from ACFs to LTCFs.

Candida albicans endocarditis associated with a contaminated aortic valve allograft: implications for regulation of allograft processing.

A patient developed Candida albicans endocarditis and fungemia after undergoing aortic valve replacement with an allograft. The allograft had been found during tissue bank processing to be contaminated with C. albicans, but it was culture-negative for C. albicans after routine disinfection with an antifungal-containing antimicrobial solution. Comparison of the preimplantation and postimplantation C. albicans isolates revealed remarkable genetic similarity, but antifungal susceptibility testing showed that the postimplantation isolate was more resistant to fluconazole and amphotericin B than the preimplantation isolate, suggesting emergence of resistance after disinfection. Implantation of a contaminated heart valve allograft can occur despite disinfection during processing and can result in endocarditis in the recipient. Antimicrobial disinfection protocols that include antifungal drugs may be ineffective. Current U.S. Food and Drug Administration regulations do not require companies to specify details concerning allograft processing. Additional measures may be required to prevent tissue bank release of allografts contaminated with C. albicans or other pathogens.