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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. [ABSTRACT FROM AUTHOR]

The article presents results from a clinical trial conducted by the American Red Cross that examined the screening of donated blood for Chagas disease, a zoonotic disease caused by the parasite Trypanosoma cruzi. The Red Cross study found that some donations tested positive for Trypanosoma cruzi. The Chagas disease screening test was developed by Ortho-Clinical Diagnostics. It is an enzyme-linked immunosorbent assay that uses epimastigote lysate antigens to detect Trypanosoma cruzi antibodies in serum and plasma.

The article reports that human tissue-processing company Biomedical Tissue Services Ltd. (BTS) recovered tissues from human donors who were not screened properly for certain infectious diseases and who might not have met donor eligibility requirements. The tissues were sent to five processors and distributed to all 50 states and other nations. The U.S. Food and Drug Administration, along with BTS and tissue processors who received the suspect tissues, issued a recall of all BTS recovered tissues. In its tissue recovery processes, BTS violated the Current Good Tissue Practice Rules, which has rules to prevent the introduction, transmission, or spread of communicable diseases. Transmission of infection via tissue allografts is rare, but still documented.

In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure. Moreover, the demand for medical products of human origin often exceeds supply, leading to dependence on international supply chains, and emerging technologies like cell and gene therapy present further challenges because of their unproven efficacy and long-term risks. Current regulatory mechanisms, especially in low- and middle-income countries, are insufficient. The World Health Organization (WHO) has both the mandate and experience to lead the development of international quality and safety standards, consistent product nomenclature, and robust traceability and biovigilance systems. An international, multistakeholder approach is critical for addressing the complexities of how medical products of human origin are used globally and for ensuring their safety. This approach will require promoting uniform product descriptions, enhancing digital communication systems and leveraging existing resources to support countries in establishing regulations for these products. As illustrated by World Health Assembly resolution WHA77.4 on transplantation in 2024, WHO's ongoing efforts to ensure the safe, efficient and ethical use of medical products of human origin worldwide provide the opportunity to galvanize international cooperation on establishing norms., ((c) 2024 The authors; licensee World Health Organization.)

Risk for transmission of SARS-CoV-2 through allogeneic human tissue transplantation is unknown. To further evaluate the risk of virus transmission, tissues were obtained from deceased donors who had tested positive for SARS-CoV-2 RNA via nasopharyngeal swab. This study evaluated an array of human tissues recovered for transplantation, including bone, tendon, skin, fascia lata, vascular tissues, and heart valves. Tissue samples and plasma or serum samples, if available, were tested for viral RNA (vRNA) using a real time PCR system for the presence of virus RNA. All samples were tested in quadruplicate for both subgenomic (sgRNA) and genomic (gRNA) RNA encoding the SARS-CoV-2 nucleocapsid gene. Amplification of a cellular housekeeping gene served as the positive control for every sample. A total of 47 tissue samples from 17 donors were tested for SARS-CoV-2 RNA. Four donors had plasma or serum available for paired testing. SARS-CoV-2 RNA was not detected from any tissue or plasma/serum sample tested. Based on these findings, risk of transmission through the transplantation of tissue types studied from SARS-CoV-2 infected donors is likely to be low., (© 2023. The Author(s).)

Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Kara Mitchell reports the following relationships with the Association of Public Health Laboratories: consultant for a public health–related doctorate program to develop molecular course content, funded travel to national meetings, and a leadership or fiduciary role with the Laboratory Systems and Standards Committee. No other potential conflicts of interest were disclosed.

Background: In 2021, four patients who had received solid organ transplants in the USA developed encephalitis beginning 2-6 weeks after transplantation from a common organ donor. We describe an investigation into the cause of encephalitis in these patients., Methods: From Nov 7, 2021, to Feb 24, 2022, we conducted a public health investigation involving 15 agencies and medical centres in the USA. We tested various specimens (blood, cerebrospinal fluid, intraocular fluid, serum, and tissues) from the organ donor and recipients by serology, RT-PCR, immunohistochemistry, metagenomic next-generation sequencing, and host gene expression, and conducted a traceback of blood transfusions received by the organ donor., Findings: We identified one read from yellow fever virus in cerebrospinal fluid from the recipient of a kidney using metagenomic next-generation sequencing. Recent infection with yellow fever virus was confirmed in all four organ recipients by identification of yellow fever virus RNA consistent with the 17D vaccine strain in brain tissue from one recipient and seroconversion after transplantation in three recipients. Two patients recovered and two patients had no neurological recovery and died. 3 days before organ procurement, the organ donor received a blood transfusion from a donor who had received a yellow fever vaccine 6 days before blood donation., Interpretation: This investigation substantiates the use of metagenomic next-generation sequencing for the broad-based detection of rare or unexpected pathogens. Health-care workers providing vaccinations should inform patients of the need to defer blood donation for at least 2 weeks after receiving a yellow fever vaccine. Despite mitigation strategies and safety interventions, a low risk of transfusion-transmitted infections remains., Funding: US Centers for Disease Control and Prevention (CDC), the Biomedical Advanced Research and Development Authority, and the CDC Epidemiology and Laboratory Capacity Cooperative Agreement for Infectious Diseases., Competing Interests: Declaration of interests LFW received research funding from Accelerate Diagnostics, bioMérieux, Hardy Diagnostics, Roche Molecular Systems, and Selux Diagnostics and honoraria from Roche Molecular Systems, Shionogi, and Talis Biomedical, all unrelated to this work. KSG received research support from ThermoFisher and has a royalty-generating collaborative agreement with ZeptoMetrix, both unrelated to this work. MRW received research grant funding from Roche/Genentech and Novartis and speaking honoraria from Genentech, Novartis, Takeda, and WebMD, all unrelated to this work. CYC received research grant funding from the Bay Area Lyme Disease Foundation and the Chan-Zuckerberg Biohub, unrelated to this work, and is on the scientific advisory board for Mammoth Biosciences, Poppy Health, and BiomeSense. MRW and CYC are consultants and co-founders of Delve Bio. CYC is a co-inventor on US patent 11380421, Pathogen Detection Using Next Generation Sequencing, under which algorithms for taxonomic classification, filtering, and pathogen detection are used by SURPI+ software., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Given the possibility for disease transmission, this study was performed to determine whether there is detectable SARS-CoV-2 viral RNA in the blood of deceased tissue donors. A retrospective analysis of blood samples from eligible deceased tissue donors from Oct 2019 through June 2020 was performed. Plasma aliquots were initially tested with a SARS-CoV-2 NAT Assay; positive samples were further tested using an alternate NAT and an antibody assay. The proportion of donors with confirmed RNAemia and 95% confidence intervals were computed. Of donor samples collected in 2019, 894 yielded valid results, with 6 initially positive, none of which confirmed positive by alternate NAT. Of donor samples collected in 2020, 2562 yielded valid initial NAT results, with 21 (0.8%) initially positive. Among those, 3 were confirmed by alternate NAT, 17 were not confirmed, and 1 had an invalid alternate NAT result. The rate of SARS-CoV-2 RNAemia in deceased tissue donors is approximately 1 per 1000, and it is unknown whether this RNAemia reflects the presence of infectious virus. Given these results, the risk of transmission through tissue is thought likely to be low., (© 2022. The Author(s).)

Emerging epidemics are challenging to track. Only a subset of cases is recognized and reported, as seen with the Zika virus (ZIKV) epidemic where large proportions of infection were asymptomatic. However, multiple imperfect indicators of infection provide an opportunity to estimate the underlying incidence of infection. We developed a modeling approach that integrates a generic Time-series Susceptible-Infected-Recovered epidemic model with assumptions about reporting biases in a Bayesian framework and applied it to the 2016 Zika epidemic in Puerto Rico using three indicators: suspected arboviral cases, suspected Zika-associated Guillain-Barré Syndrome cases, and blood bank data. Using this combination of surveillance data, we estimated the peak of the epidemic occurred during the week of August 15, 2016 (the 33rd week of year), and 120 to 140 (50% credible interval [CrI], 95% CrI: 97 to 170) weekly infections per 10,000 population occurred at the peak. By the end of 2016, we estimated that approximately 890,000 (95% CrI: 660,000 to 1,100,000) individuals were infected in 2016 (26%, 95% CrI: 19% to 33%, of the population infected). Utilizing multiple indicators offers the opportunity for real-time and retrospective situational awareness to support epidemic preparedness and response., Competing Interests: The authors have declared that no competing interests exist.

Background: Red breast syndrome (RBS) is a noninfectious erythema associated with acellular dermal matrix (ADM). The underlying cause remains unknown despite multiple suggested etiologies. No similar presentations to RBS have been reported in other anatomic regions., Objectives: The authors sought to describe and identify a common etiology for ADM-associated sterile inflammation in the breast and upper extremity., Methods: A retrospective review of medical complaints reported to MTF Biologics (Edison, NJ) from July 1, 2017 to January 3, 2018 was performed. Inventory samples were tested for endotoxin content in endotoxin units (eu) via the Limulus Amebocyte Lysate method to determine a common etiology for sterile inflammation., Results: Cases of RBS and upper extremity sterile inflammation, "red hand syndrome," are presented. Two patients developed RBS following implantation of ADM from the same donor; associated grafts in inventory had endotoxin levels of 167 eu and 320 eu per graft, respectively. Two patients developed red hand syndrome after joint arthroplasty with ADM from another donor; associated graft in inventory showed an endotoxin level of 1282 eu. Cultures were obtained and negative in 3 of the 4 cases. Since endotoxin screening of ADM donor lots began in January 2018 at MTF Biologics, no cases of sterile inflammation have been reported from screened units through December 31, 2018 (RBS rate, 39/15,529 [0.25%] vs 0/18,275 [0%], P < 0.0001)., Conclusions: The sterile inflammatory response in RBS and newly reported red hand syndrome may be attributable to the presence of endotoxin in implanted ADM. Endotoxin screening has been adopted by MTF Biologics with a significant decrease in reported reactions., (© 2019 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.)

Background: Between 2002 and 2013, the organs of 13 deceased donors with infectious encephalitis were transplanted, causing infections in 23 recipients. As a consequence, organs from donors showing symptoms of encephalitis (increased probability of infectious encephalitis (IPIE) organs) might be declined. We had previously characterized the risk of IPIE organs using data available to most transplant teams and not requiring special diagnostic tests. If the probability of infection is low, the benefits of a transplant from a donor with suspected infectious encephalitis might outweigh the risk and could be lifesaving for some transplant candidates., Methods: Using organ transplant data and Cox Proportional Hazards models, we determined liver donor and recipient characteristics predictive of post-transplant or waitlist survival and generated 5-year survival probability curves. We also calculated expected waiting times for an organ offer based on transplant candidate characteristics. Using a limited set of actual cases of infectious encephalitis transmission via transplant, we estimated post-transplant survival curves given an organ from an IPIE donor., Results: 54% (1256) of patients registered from 2002-2006 who died or were removed from the waiting list because of deteriorated condition within 1 year could have had an at least marginal estimated benefit by accepting an IPIE liver with some probability of infection, with the odds increasing to 86% of patients if the probability of infection was low (5% or less). Additionally, 54% (1252) were removed from the waiting list prior to their estimated waiting time for a non-IPIE liver and could have benefited from an IPIE liver., Conclusion: Improved allocation and utilization of IPIE livers could be achieved by evaluating the patient-specific trade-offs between (a) accepting an IPIE liver and (b) remaining on the waitlist and accepting a non-IPIE liver after the estimated waiting time., (Published 2019. This article is a U.S. Government work and is in the public domain in the USA.)

Transfusion-transmitted infections (TTIs) can be severe and result in death. Transfusion-transmitted viral pathogen transmission has been substantially reduced, whereas sepsis due to bacterial contamination of platelets and transfusion-transmitted babesiosis may occur more frequently. Quantifying the burden of TTI is important to develop targeted interventions. From January 1, 2010, to December 31, 2016, health care facilities participating in the National Healthcare Safety Network Hemovigilance Module monitored transfusion recipients for evidence of TTI and recorded the total number of units transfused. Facilities use standard criteria to report TTIs. Incidence rates of TTIs, including for bacterial contamination of platelets and transfusion-transmitted babesiosis, are presented. One hundred ninety-five facilities reported 111 TTIs and 7.9 million transfused components to the National Healthcare Safety Network Hemovigilance Module. Of these 111 reports, 54 met inclusion criteria. The most frequently reported pathogens were Babesia spp in RBCs (16/23, 70%) and Staphylococcus aureus in platelets (12/30, 40%). There were 1.95 (26 apheresis, 4 whole blood derived) TTIs per 100 000 transfused platelet units and 0.53 TTI per 100 000 transfused RBC components, compared to 0.68 TTI per 100 000 all transfused components. Bacterial contamination of platelets and transfusion-transmitted babesiosis were the most frequently reported TTIs. Interventions that reduce the burden of bacterial contamination of platelets, particularly collected by apheresis, and Babesia transmission through RBC transfusion would reduce transfusion recipient morbidity and mortality. These analyses demonstrate the value and importance of facility participation in national recipient hemovigilance using standard reporting criteria., (Published by Elsevier Inc.)

Introduction: The National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) collects data on the frequency, severity, and imputability of transfusion-associated adverse events. These events contribute to significant morbidity and mortality among transfusion patients. We report results from the first systematic assessment of eight attributes of the HM., Materials and Methods: Standard methods were used to assess the HM. Evaluation data included training materials, system modification history, and facility survey information. A concordance analysis was performed using data from the Baystate Medical Center's (Springfield, MA) electronic transfusion reporting system., Results: In 2016, system representativeness remained low, with 6% (277 of 4690) of acute care facilities across 43 jurisdictions enrolled in the HM. In 2016, 48% (2147 of 4453) and 89% (3969 of 4,453) of adverse reactions were reported within 30 and 90 days of the reaction date, respectively, compared to 21% (109 of 511) and 56% (284 of 511) in 2010, demonstrating improved reporting timeliness. Data quality from most reactions was adequate, with 10% (45 of 442) misclassified transfusion-associated circulatory overload reactions, and no incomplete transfusion-transmitted infection data reported from 2010 to 2013. When compared to the Baystate system to assess concordance, 43% (24 of 56) of NHSN-reported febrile reactions were captured in both systems (unweighted kappa value, 0.47; confidence interval, 0.33-0.61)., Conclusion: Since the 2010 HM pilot, improvements have led to enhanced simplicity, timeliness, and strengthened data quality. The HM serves an important and unique role despite incomplete adoption nationwide. Facility efforts to track and prevent transfusion-associated adverse events through systems like the NHSN HM are a key step toward improving transfusion safety in the United States., (© 2018 AABB.)

Background: There were 13 documented clusters of infectious encephalitis transmission via organ transplant from deceased donors to recipients during 2002-2013. Hence, organs from donors diagnosed with encephalitis are often declined because of concerns about the possibility of infection, given that there is no quick and simple test to detect causes of infectious encephalitis., Methods: We constructed a database containing cases of infectious and non-infectious encephalitis. Using statistical imputation, cross-validation, and regression techniques, we determined deceased organ donor characteristics, including demographics, signs, symptoms, physical exam, and laboratory findings, predictive of infectious vs non-infectious encephalitis, and developed a calculator which assesses the risk of infection., Results: Using up to 12 predictive patient characteristics (with a minimum of 3, depending on what information is available), the calculator provides the probability that a donor may have infectious vs non-infectious encephalitis, improving the prediction accuracy over current practices. These characteristics include gender, fever, immunocompromised state (other than HIV), cerebrospinal fluid elevation, altered mental status, psychiatric features, cranial nerve abnormality, meningeal signs, focal motor weakness, Babinski's sign, movement disorder, and sensory abnormalities., Conclusion: In the absence of definitive diagnostic testing in a potential organ donor, infectious encephalitis can be predicted with a risk score. The risk calculator presented in this paper represents a prototype, establishing a framework that can be expanded to other infectious diseases transmissible through solid organ transplantation., (Published 2018. This article is a U.S. Government work and is in the public domain in the USA.)

For >60 years, Zika virus (ZIKV) has been recognized as an arthropod-borne virus with Aedes species mosquitoes as the primary vector. However in the past 10 years, multiple alternative routes of ZIKV transmission have been identified. We review the available data on vector and non-vector-borne modes of transmission and interventions undertaken, to date, to reduce the risk of human infection through these routes. Although much has been learned during the outbreak in the Americas on the underlying mechanisms and pathogenesis of non-vector-borne ZIKV infections, significant gaps remain in our understanding of the relative incidence of, and risk from, these modes compared to mosquito transmission. Additional research is urgently needed on the risk, pathogenesis, and effectiveness of measures to mitigate non-vector-borne ZIKV transmission., (Published by Oxford University Press for the Infectious Diseases Society of America 2017. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Background: Mycoplasma hominis is a commensal genitourinary tract organism that can cause infections outside the genitourinary tract. We investigated a cluster of M. hominis surgical site infections in patients who underwent spine surgery, all associated with amniotic tissue linked to a common donor., Methods: Laboratory tests of tissue product from the donor, including culture, quantitative real-time polymerase chain reaction (qPCR), and whole-genome sequencing were performed. Use of this amniotic tissue product was reviewed. A multistate investigation to identify additional cases and locate any unused products was conducted., Results: Twenty-seven tissue product vials from a donor were distributed to facilities in 7 states; at least 20 vials from this donor were used in 14 patients. Of these, 4 of 14 (29%) developed surgical site infections, including 2 M. hominis infections. Mycoplasma hominis was detected by culture and qPCR in 2 unused vials from the donor. Sequencing indicated >99% similarity between patient and unopened vial isolates. For 5 of 27 (19%) vials, the final disposition could not be confirmed., Conclusions: Mycoplasma hominis was transmitted through amniotic tissue from a single donor to 2 recipients. Current routine donor screening and product testing does not detect all potential pathogens. Clinicians should be aware that M. hominis can cause surgical site infections, and may not be detected by routine clinical cultures. The lack of a standardized system to track tissue products in healthcare facilities limits the ability of public health agencies to respond to outbreaks and investigate other adverse events associated with these products.

Background: In 2011 and 2013, the National Blood Collection and Utilization Survey (NBCUS) revealed declines in blood collection and transfusion in the United States. The objective of this study was to describe blood services in 2015., Study Design and Methods: The 2015 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, deferred, distributed, transfused, and outdated., Results: Response rates for the 2015 NBCUS were 78.4% for blood collection centers and 73.9% for transfusing hospitals. In 2015, 12,591,000 units of red blood cells (RBCs) (95% confidence interval [CI], 11,985,000-13,197,000 units of RBCs) were collected, and 11,349,000 (95% CI, 10,592,000-11,747,000) were transfused, representing declines since 2013 of 11.6% and 13.9%, respectively. Total platelet units distributed (2,436,000; 95% CI, 2,230,000-2,642,000) and transfused (1,983,000; 95% CI, 1,816,000 = 2,151,000) declined by 0.5% and 13.1%, respectively, since 2013. Plasma distributions (3,714,000; 95% CI, 3,306,000-4,121,000) and transfusions (2,727,000; 95% CI, 2,594,000-2,859,000) in 2015 declined since 2013. The median price paid per unit in 2015-$211 for leukocyte-reduced RBCs, $524 for apheresis platelets, and $54 for fresh frozen plasma-was less for all components than in 2013., Conclusions: The 2015 NBCUS findings suggest that continued declines in demand for blood products resulted in fewer units collected and distributed Maintaining a blood inventory sufficient to meet routine and emergent demands will require further monitoring and understanding of these trends., (© 2017 AABB.)

Background: In August 2016, the Food and Drug Administration advised US blood centers to screen all whole blood and apheresis donations for Zika virus (ZIKV) with an individual-donor nucleic acid test (ID-NAT) or to use approved pathogen reduction technology (PRT). The cost of implementing this guidance nationally has not been assessed., Study Design and Methods: Scenarios were constructed to characterize approaches to ZIKV screening, including universal ID-NAT, risk-based seasonal allowance of minipool (MP) NAT by state, and universal MP-NAT. Data from the 2015 National Blood Collection and Utilization Survey (NBCUS) were used to characterize the number of donations nationally and by state. For each scenario, the estimated cost per donor ($3-$9 for MP-NAT, $7-$13 for ID-NAT) was multiplied by the estimated number of relevant donations from the NBCUS. Cost of PRT was calculated by multiplying the cost per unit ($50-$125) by the number of units approved for PRT. Prediction intervals for costs were generated using Monte Carlo simulation methods., Results: Screening all donations in the 50 states and DC for ZIKV by ID-NAT would cost $137 million (95% confidence interval [CI], $109-$167) annually. Allowing seasonal MP-NAT in states with lower ZIKV risk could reduce NAT screening costs by 18% to 25%. Application of PRT to all platelet (PLT) and plasma units would cost $213 million (95% CI, $156-$304)., Conclusion: Universal ID-NAT screening for ZIKV will cost US blood centers more than $100 million annually. The high cost of PRT for apheresis PLTs and plasma could be mitigated if, once validated, testing for transfusion transmissible pathogens could be eliminated., (© 2017 AABB.)

Puerto Rico has been heavily impacted by Zika virus, a mosquitoborne flavivirus that emerged in the Americas during 2015. Although most persons with Zika virus show no symptoms, the virus can cause neurologic and other complications, including fetal microcephaly. Local Zika virus transmission in Puerto Rico has been reported since December 2015. To prevent transfusion-associated transmission, local blood collection ceased in March 2016 but resumed in April 2016 after Zika virus screening of blood donations became available. Using data from screening of blood donations collected by the 2 largest blood centers in Puerto Rico during April 3-August 12, 2016, and assuming a 9.9-day duration of viremia, we estimated that 469,321 persons in Puerto Rico were infected during this period, for an estimated cumulative incidence of 12.9%. Results from blood donation screening during arboviral outbreaks can supplement routine clinical and surveillance data for improved targeting of prevention efforts.

Background: In 2013, guidelines were released for reducing the risk of viral bloodborne pathogen transmission through organ transplantation. Eleven criteria were described that result in a donor being designated at increased infectious risk. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) transmission risk from an increased-risk donor (IRD), despite negative nucleic acid testing (NAT), likely varies based on behavior type and timing., Methods: We developed a Monte Carlo risk model to quantify probability of HIV among IRDs. The model included NAT performance, viral load dynamics, and per-act risk of acquiring HIV by each behavior. The model also quantifies the probability of HCV among IRDs by non-medical intravenous drug use (IVDU)., Results: Highest risk is among donors with history of unprotected, receptive anal male-to-male intercourse with partner of unknown HIV status (MSM), followed by sex with an HIV-infected partner, IVDU, and sex with a commercial sex worker., Conclusion: With NAT screening, the estimated risk of undetected HIV remains small even at 1 day following a risk behavior. The estimated risk for HCV transmission through IVDU is likewise small and decreases quicker with time owing to the faster viral growth dynamics of HCV compared with HIV. These findings may allow for improved organ allocation, utilization, and recipient informed consent., (© 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Although transmission of hepatitis A virus (HAV) through blood transfusion has been documented, transmission through organ transplantation has not been reported. In August 2015, state health officials in Texas, USA, were notified of 2 home health nurses with HAV infection whose only common exposure was a child who had undergone multi-visceral organ transplantation 9 months earlier. Specimens from the nurses, organ donor, and all organ recipients were tested and medical records reviewed to determine a possible infection source. Identical HAV RNA sequences were detected from the serum of both nurses and the organ donor, as well as from the multi-visceral organ recipient's serum and feces; this recipient's posttransplant liver and intestine biopsy specimens also had detectable virus. The other organ recipients tested negative for HAV RNA. Vaccination of the donor might have prevented infection in the recipient and subsequent transmission to the healthcare workers.

In April 2014, a kidney transplant recipient in the United States experienced headache, diplopia, and confusion, followed by neurologic decline and death. An investigation to evaluate the possibility of donor-derived infection determined that 3 patients had received 4 organs (kidney, liver, heart/kidney) from the same donor. The liver recipient experienced tremor and gait instability; the heart/kidney and contralateral kidney recipients were hospitalized with encephalitis. None experienced gastrointestinal symptoms. Encephalitozoon cuniculi was detected by tissue PCR in the central nervous system of the deceased kidney recipient and in renal allograft tissue from both kidney recipients. Urine PCR was positive for E. cuniculi in the 2 surviving recipients. Donor serum was positive for E. cuniculi antibodies. E. cuniculi was transmitted to 3 recipients from 1 donor. This rare presentation of disseminated disease resulted in diagnostic delays. Clinicians should consider donor-derived microsporidial infection in organ recipients with unexplained encephalitis, even when gastrointestinal manifestations are absent.

The introduction of Zika virus into the Region of the Americas (Americas) and the subsequent increase in cases of congenital microcephaly resulted in activation of CDC's Emergency Operations Center on January 22, 2016, to ensure a coordinated response and timely dissemination of information, and led the World Health Organization to declare a Public Health Emergency of International Concern on February 1, 2016. During the past year, public health agencies and researchers worldwide have collaborated to protect pregnant women, inform clinicians and the public, and advance knowledge about Zika virus (Figure 1). This report summarizes 10 important contributions toward addressing the threat posed by Zika virus in 2016. To protect pregnant women and their fetuses and infants from the effects of Zika virus infection during pregnancy, public health activities must focus on preventing mosquito-borne transmission through vector control and personal protective practices, preventing sexual transmission by advising abstention from sex or consistent and correct use of condoms, and preventing unintended pregnancies by reducing barriers to access to highly effective reversible contraception.

CDC has updated its interim guidance for persons with possible Zika virus exposure who are planning to conceive (1) and interim guidance to prevent transmission of Zika virus through sexual contact (2), now combined into a single document. Guidance for care for pregnant women with possible Zika virus exposure was previously published (3). Possible Zika virus exposure is defined as travel to or residence in an area of active Zika virus transmission (http://www.cdc.gov/zika/geo/index.html), or sex* without a condom † with a partner who traveled to or lived in an area of active transmission. Based on new though limited data, CDC now recommends that all men with possible Zika virus exposure who are considering attempting conception with their partner, regardless of symptom status, § wait to conceive until at least 6 months after symptom onset (if symptomatic) or last possible Zika virus exposure (if asymptomatic). Recommendations for women planning to conceive remain unchanged: women with possible Zika virus exposure are recommended to wait to conceive until at least 8 weeks after symptom onset (if symptomatic) or last possible Zika virus exposure (if asymptomatic). Couples with possible Zika virus exposure, who are not pregnant and do not plan to become pregnant, who want to minimize their risk for sexual transmission of Zika virus should use a condom or abstain from sex for the same periods for men and women described above. Women of reproductive age who have had or anticipate future Zika virus exposure who do not want to become pregnant should use the most effective contraceptive method that can be used correctly and consistently. These recommendations will be further updated when additional data become available.

Background: During 2009 and 2010, 2 clusters of organ transplant-transmitted Balamuthia mandrillaris, a free-living ameba, were detected by recognition of severe unexpected illness in multiple recipients from the same donor., Methods: We investigated all recipients and the 2 donors through interview, medical record review, and testing of available specimens retrospectively. Surviving recipients were tested and treated prospectively., Results: In the 2009 cluster of illness, 2 kidney recipients were infected and 1 died. The donor had Balamuthia encephalitis confirmed on autopsy. In the 2010 cluster, the liver and kidney-pancreas recipients developed Balamuthia encephalitis and died. The donor had a clinical syndrome consistent with Balamuthia infection and serologic evidence of infection. In both clusters, the 2 asymptomatic recipients were treated expectantly and survived; 1 asymptomatic recipient in each cluster had serologic evidence of exposure that decreased over time. Both donors had been presumptively diagnosed with other neurologic diseases prior to organ procurement., Conclusions: Balamuthia can be transmitted through organ transplantation with an observed incubation time of 17-24 days. Clinicians should be aware of Balamuthia as a cause of encephalitis with high rate of fatality, and should notify public health departments and evaluate transplant recipients from donors with signs of possible encephalitis to facilitate early diagnosis and targeted treatment. Organ procurement organizations and transplant centers should be aware of the potential for Balamuthia infection in donors with possible encephalitis and also assess donors carefully for signs of neurologic infection that may have been misdiagnosed as stroke or as noninfectious forms of encephalitis., (Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Background: The Department of Health and Human Services National Blood Collection and Utilization Survey (NBCUS) has been conducted biennially since 1997. Data are used to estimate national blood collection and utilization., Study Design and Methods: The 2013 Department of Health and Human Services NBCUS is a cross-sectional survey of all US blood collection centers and hospitals as listed in the 2012 American Hospital Association Annual Survey database that perform at least 100 inpatient surgical procedures annually. The study objective was to estimate, with 95% confidence intervals (CIs), the number of blood and blood components collected and transfused in the United States., Results: In 2013, a total of 14,237,000 whole blood and apheresis red blood cell (RBC) units (95% CI, 13,639,000-14,835,000) were collected with 13,395,000 available for transfusion. Of these, 13,180,000 (95% CI, 12,389,000-13,972,000) whole blood and RBC units were transfused. This represented a 4.4% decline in the number of transfused units compared to 2011. Outdated (i.e., expired without being transfused) whole blood and RBC units declined by 17.3%. Apheresis (2,318,000; 95% CI, 2,154,000-2,482,000) and whole blood-derived platelet (PLT; 130,000; 95% CI, 23,000-237,000) distribution declined in 2013. Total PLT transfusions increased in 2013 (2,281,000) in comparison to 2011 (2,169,000). Total plasma units distributed (4,338,000) and transfused (3,624,000) declined., Conclusion: Both blood collection and utilization have declined, but the gap between collection and utilization is narrowing. As collections decline further and hospitals decrease transfusions and manage products more efficiently, the decline in surplus inventory may be a concern for disaster preparedness or other unexpected utilization needs., (© 2016 AABB.)

Zika virus is a flavivirus transmitted primarily by Aedes aegypti and Aedes albopictus mosquitoes, and infection can be asymptomatic or result in an acute febrile illness with rash (1). Zika virus infection during pregnancy is a cause of microcephaly and other severe birth defects (2). Infection has also been associated with Guillain-Barré syndrome (GBS) (3) and severe thrombocytopenia (4,5). In December 2015, the Puerto Rico Department of Health (PRDH) reported the first locally acquired case of Zika virus infection. This report provides an update to the epidemiology of and public health response to ongoing Zika virus transmission in Puerto Rico (6,7). A confirmed case of Zika virus infection is defined as a positive result for Zika virus testing by reverse transcription-polymerase chain reaction (RT-PCR) for Zika virus in a blood or urine specimen. A presumptive case is defined as a positive result by Zika virus immunoglobulin M (IgM) enzyme-linked immunosorbent assay (MAC-ELISA)* and a negative result by dengue virus IgM ELISA, or a positive test result by Zika IgM MAC-ELISA in a pregnant woman. An unspecified flavivirus case is defined as positive or equivocal results for both Zika and dengue virus by IgM ELISA. During November 1, 2015-July 7, 2016, a total of 23,487 persons were evaluated by PRDH and CDC Dengue Branch for Zika virus infection, including asymptomatic pregnant women and persons with signs or symptoms consistent with Zika virus disease or suspected GBS; 5,582 (24%) confirmed and presumptive Zika virus cases were identified. Persons with Zika virus infection were residents of 77 (99%) of Puerto Rico's 78 municipalities. During 2016, the percentage of positive Zika virus infection cases among symptomatic males and nonpregnant females who were tested increased from 14% in February to 64% in June. Among 9,343 pregnant women tested, 672 had confirmed or presumptive Zika virus infection, including 441 (66%) symptomatic women and 231 (34%) asymptomatic women. One patient died after developing severe thrombocytopenia (4). Evidence of Zika virus infection or recent unspecified flavivirus infection was detected in 21 patients with confirmed GBS. The widespread outbreak and accelerating increase in the number of cases in Puerto Rico warrants intensified vector control and personal protective behaviors to prevent new infections, particularly among pregnant women.

Transfusion-transmitted infections have been documented for several arboviruses, including West Nile and dengue viruses (1). Zika virus, a flavivirus transmitted primarily by Aedes aegypti mosquitoes that has been identified as a cause of congenital microcephaly and other serious brain defects (2), became recognized as a potential threat to blood safety after reports from a 2013-2014 outbreak in French Polynesia. Blood safety concerns were based on very high infection incidence in the population at large during epidemics, the high percentage of persons with asymptomatic infection, the high proportion of blood donations with evidence of Zika virus nucleic acid upon retrospective testing, and an estimated 7-10-day period of viremia (3). At least one instance of transfusion transmission of Zika virus has been documented in Brazil after the virus emerged there, likely in 2014 (4). Rapid epidemic spread has followed to other areas of the Americas, including Puerto Rico.

Background: This article reports key findings of an evaluation of the AABB Uniform Donor History Questionnaire (a self-administered form completed before blood donation). The purpose of the study was to examine how respondents understand the questions and assess the nature of inaccurate responses. Another goal was to determine whether men who have sex with men (MSM) interpreted questions differently from non-MSM and whether questions were interpreted differently in various regions of the country., Study Design and Methods: Cognitive interviewing was used for the study. This is a qualitative method that investigates how survey questions perform. It consists of semistructured interviews that explore whether respondents understand questions as intended and whether they can provide accurate answers. A total of 166 interviews were conducted., Results: Respondents had an overwhelmingly similar understanding of the purpose of the questionnaire as assessing the safety of their blood for donation. This understanding framed respondents' interpretations such that each question was understood as asking the same thing; that is, "Is my blood safe to donate?" This interpretation did not vary among MSM versus non-MSM or by region., Conclusion: Respondents understood the questionnaire as assessing the safety of their blood. This interpretation served as the backdrop for the question-response process for each individual question. Specifically, rationale for answers was framed as much or more by the questionnaire's general purpose as by the specific topic of individual questions. This pattern of interpretation was the key factor responsible for both false-positive and false-negative response errors and did not vary by demographic, including in MSM., (Published 2016. This article is a U.S. Government work and is in the public domain in the USA 2016 AABB.)

Since November 2015, Puerto Rico has reported active mosquito-borne transmission of Zika virus. Because of the potential for Zika virus to be transmitted through transfusion of blood components, and because a high percentage of persons infected with Zika virus are asymptomatic, the Food and Drug Administration (FDA) recommended that blood collections cease in areas of the United States affected by active vector-borne transmission of Zika virus until laboratory screening of blood donations or pathogen reduction technology (PRT) for treatment of blood components can be implemented. To inform efforts to maintain the safety and availability of the blood supply in Puerto Rico, CDC, in collaboration with the Puerto Rico Department of Health, conducted a rapid assessment of blood collection and use on the island. A total of 139,369 allogeneic red blood cell (RBC) units, 45,243 platelet units, and 56,466 plasma units were collected in or imported to Puerto Rico during 2015, and 135,966 allogeneic RBC units, 13,526 therapeutic platelet units, and 25,775 plasma units were transfused. Because of the potential for local Zika virus transmission in areas with a competent mosquito vector, other areas of the United States should develop plans to ensure local blood safety and adequacy. Blood collection organizations and public health agencies should collaborate to maintain the safety and availability of local blood supplies in accordance with FDA guidance.

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., (© Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: In 2010, health care facilities in the United States began voluntary enrollment in the National Healthcare Safety Network (NHSN) Hemovigilance Module. Participants report transfusion practices; red blood cell, platelet (PLT), plasma, and cryoprecipitate units transfused; and transfusion-related adverse reactions and process errors to the Centers for Disease Control and Prevention through a secure, Internet-accessible surveillance application available to transfusing facilities., Study Design and Methods: Facilities submitting at least 1 month of transfused components data and adverse reactions from January 1, 2010, to December 31, 2012, were included in this analysis. Adverse reaction rates for transfused components, stratified by component type and collection and modification methods, were calculated., Results: In 2010 to 2012, a total of 77 facilities reported 5136 adverse reactions among 2,144,723 components transfused (239.5/100,000). Allergic (46.8%) and febrile nonhemolytic (36.1%) reactions were most frequent; 7.2% of all reactions were severe or life-threatening and 0.1% were fatal. PLT transfusions (421.7/100,000) had the highest adverse reaction rate., Conclusion: Adverse transfusion reaction rates from the NHSN Hemovigilance Module in the United States are comparable to early hemovigilance reporting from other countries. Although severe reactions are infrequent, the numbers of transfusion reactions in US hospitals suggest that interventions to prevent these reactions are important for patient safety. Further investigation is needed to understand the apparent increased risk of reactions from apheresis-derived blood components. Comprehensive evaluation, including data validation, is important to continued refinement of the module., (Published 2014. This article is a U.S. Government work and is in the public domain in the USA.)

A national recipient hemovigilance system was introduced in the United States in 2010, when voluntary enrollment began as part of the National Healthcare Safety Network (NHSN) Hemovigilance Module. NHSN is a secure, Web-based surveillance system operated by the Centers for Disease Control and Prevention and used by US health care facilities to report a variety of patient safety information. The Hemovigilance Module is used for comprehensive monitoring of transfusion-related adverse events. Participating facilities can utilize analytic tools available within the module to identify opportunities for enhancing transfusion safety, evaluate the effectiveness of interventions, and compare facility specific transfusion-related data to aggregate national estimates. Data may be voluntarily shared by facilities with external partners for patient safety improvement initiatives and to fulfill reporting mandates. We describe the key characteristics of the Hemovigilance Module, highlight the benefits for participating facilities, and discuss the use of reported data for establishing national estimates of transfusion-associated adverse events to identify gaps in transfusion safety and opportunities for interventions. National hemovigilance systems are essential to recognize gaps in transfusion safety and identify opportunities for interventions to improve patient safety and outcomes., (Published 2015. This article is a U.S. Government work and is in the public domain in the USA.)

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., (© Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The cause of encephalitis among solid organ transplant recipients may be multifactorial; the disease can result from infectious or noninfectious etiologies. During 2002-2013, the US Centers for Disease Control and Prevention investigated several encephalitis clusters among transplant recipients. Cases were caused by infections from transplant-transmitted pathogens: West Nile virus, rabies virus, lymphocytic choriomeningitis virus, and Balamuthia mandrillaris amebae. In many of the clusters, identification of the cause was complicated by delayed diagnosis due to the rarity of the disease, geographic distance separating transplant recipients, and lack of prompt recognition and reporting systems. Establishment of surveillance systems to detect illness among organ recipients, including communication among transplant center physicians, organ procurement organizations, and public health authorities, may enable the rapid discovery and investigation of infectious encephalitis clusters. These transplant-transmitted pathogen clusters highlight the need for greater awareness among clinicians, pathologists, and public health workers, of emerging infectious agents causing encephalitis among organ recipients.