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Steven Kleinman

Publications and source records attributed to Steven Kleinman.

11 recordsLinked to original sources

The development of West Nile virus safety policies by Canadian blood services: guiding principles and a comparison between Canada and the United States.

To address the emerging threat of West Nile virus (WNV) to the blood supply, Canadian Blood Services (CBS) made a series of policy decisions that were either similar to those adopted in the United States or more stringent than policies formulated in the United States at the same time. More stringent Canadian policies included the development of an in-house WNV RNA assay, the stockpiling of frozen plasma components in the winter for transfusion in WNV-affected areas in the summer, a special recruitment campaign for red blood cell collections before the start of the 2003 WNV season, and an inventory exchange (ie, WNV-tested for untested red blood cells) initiated 2 weeks after the onset of WNV screening, as well as the implementation of targeted individual-donation WNV testing on August 2, 2004, in the absence of any positive donors or clinical cases of WNV infection in Canada. The general principles that guided CBS decision making with regard to WNV safety included application of the precautionary principle, harmonization with policies in the United States, a consideration of logistic issues, compliance with Health Canada requests, responsiveness to public expectations about transfusion safety, and transparency in decision making with timely communication to stakeholders. Before implementing WNV blood safety policies, CBS assessed their impact on blood availability. When policies were implemented, data were obtained quickly to ensure that the prior impact assessments were accurate. This review discusses the guiding principles affecting CBS policy development and compares CBS WNV safety policies to policies adopted in the United States.

Antibodies, Viral↗

Correlates of hepatitis C virus (HCV) RNA negativity among HCV-seropositive blood donors.

BACKGROUND: Approximately 20 percent of persons infected with hepatitis C virus (HCV) clear viremia. Factors associated with resolution of viremia are not well defined. Implementation of routine nucleic acid testing (NAT) of blood donors has yielded a large data set for analysis of demographic correlates of resolved viremia. STUDY DESIGN AND METHODS: HCV antibody and NAT data, liver enzyme (alanine aminotransferase [ALT]) results, and donor demographic characteristics were compiled for 2,579,290 allogeneic donations given at five large blood centers after NAT implementation in 1999 through December 2001. Donation HCV RNA status was compared between first-time donors categorized by ALT levels, sex, age, race and/or ethnicity, country of birth, level of education, blood center location, and blood group, with chi-square tests and multivariable logistic regression methods. RESULTS: Of 35 confirmed-seropositive repeat donors, 19 (54.3%) tested negative for the presence of HCV RNA; there was no association between RNA status and preseroconversion intervals (p = 0.74). Of 2105 RIBA-positive, first-time donors, 402 (19.1%) tested negative for the presence of HCV RNA by NAT (presumptive resolved infections). There were significant differences in the frequency of RNA negativity among first-time donors categorized by ALT levels and by race and/or ethnicity. ALT levels were more likely to be elevated in RNA-positive, first-time donors (p < 0.0001). Viremia was less likely to resolve in Asian (8.2%) and black non-Hispanic (14.4%) donors than in white non-Hispanic (20.7%), Hispanic (22.1%), and other race and/or ethnicity (22.1%) donors (p = 0.02). No significant associations were found for age, sex, country of origin, level of education, blood type, and donor center location. CONCLUSION: These results confirm that the frequency of HCV RNA negativity among seropositive persons differs by race and/or ethnicity. Follow-up studies of donors with resolved viremia are warranted to further elucidate viral, immunologic, and genetic factors underlying spontaneous viral clearance.

Adult↗

The 2003 West Nile virus United States epidemic: the America's Blood Centers experience.

BACKGROUND: A detailed assessment of West Nile virus (WNV) yield is needed to evaluate the effectiveness of the WNV nucleic acid amplification technology (NAT) screening implemented in 2003. STUDY DESIGN AND METHODS: WNV NAT screening and donation data were compiled from members of America's Blood Centers, which collect nearly 50 percent of the US blood supply. WNV RNA screening was performed with either the Gen-Probe/Chiron Procleix transcription-mediated amplification assay or the Roche TaqScreen polymerase chain reaction. Results of alternate NAT and WNV immunoglobulin M (IgM) antibody assays conducted on index and follow-up samples were obtained from test manufacturers. Presumed WNV positivity was based on NAT repeat reactivity of the individual index donation whereas confirmatory status was based on additional IgM testing of the index donation and NAT and serology testing of follow-up samples. RESULTS: From July through October 2003, 2.5 million donations were screened for WNV RNA. Of 877 NAT-reactive donations (screening positivity rate of 3.5 per 10,000 units), 430 (49%) were confirmed positive, whereas 68 (8%) lacking follow-up data remained presumed positive. The sensitivity and positive predictive value of a presumed viremic result relative to final confirmatory status were 92 and 99 percent, respectively. WNV activity was highest in the central plains with prevalence per 10,000 peaking August 1 to 15 in Colorado (67.7) and South Dakota (77.5) and August 16 to 31 in Wyoming (74.1) and North Dakota (102.0). CONCLUSIONS: WNV screening interdicted many viremic units, thereby reducing transfusion-transmitted infections. This study demonstrates that a national collaborative effort facilitates timely surveillance of blood donor infectious disease prevalence rates.

Blood Banks↗

Does prevalence of transfusion-transmissible viral infection reflect corresponding incidence in United States blood donors?

BACKGROUND: Calculation of viral residual risk is dependent on estimating incidence, which is not easily obtainable by most blood centers. Prevalence, however, is readily available. Understanding whether prevalence reflects corresponding incidence may help blood centers monitor disease risks. STUDY DESIGN AND METHODS: With data on 12 million allogeneic donations, prevalence and incidence of transfusion-transmitted viral infections (TTVIs) were calculated. Relationships between prevalence (in total, first-time, and repeat donations) and incidence were analyzed for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) relative to temporal and donor demographic stratifications, respectively. RESULTS: Overall prevalence of HIV, HBV, and HCV did not consistently reflect corresponding incidence. The relationship between prevalence and incidence varied with time and donors' age and was virus-specific. CONCLUSION: Incidence of TTVIs cannot be easily predicted from overall prevalence. Accurate assessment of TTVI risk necessitates knowledge about donation histories and person-years at risk. Establishing comprehensive frameworks for monitoring blood donations and infectious disease markers remains a key to monitoring blood safety.

Blood Banks↗

Survival after transfusion as assessed in a large multistate US cohort.

BACKGROUND: The only survival and mortality data on a general population of transfused patients in the United States is more than two decades old. More contemporary data are needed to reflect more current patient populations and transfusion practices. STUDY DESIGN AND METHODS: Data were extracted from Constella Health Strategies Sciences' managed-care administrative claims database that contains private health care claims. Patients were selected if they had at least one professional or facility claim indicating transfusion in 1995. Only the first transfusion in the time period was included so that each patient was counted only once and all claims were unduplicated. Survival for five years after transfusion was the primary outcome measure. RESULTS: A total of 6779 patients were included in the analysis. A total of 4658 (69%) patients were alive 1 year after transfusion, 4056 (60%) were alive at 2 years, and 3092 (46%) were alive 5 years after transfusion. Overall annual mortality was 31 percent in Year 1 after transfusion, 14 percent in Year 2, and 10 percent in each of Years 3 through 5. Transfusion mortality was much higher in recipients older than age 65 at the time of transfusion, who comprised 60 percent of transfused patients. CONCLUSION: These data from the mid 1990s can be used in models of the effectiveness of risk reduction interventions and in models of the disease consequences of infections transmitted through blood transfusions.

Adolescent↗

The donor notification process from the donor's perspective.

BACKGROUND: Despite large numbers of blood donors being notified of abnormal infectious disease screening results, there has been little scientific study of the effects of this process. STUDY DESIGN AND METHODS: With a 28-item questionnaire, an anonymous mail survey was conducted of 4141 blood donors notified of 15 distinct categories of abnormal infectious disease screening and confirmatory test results. RESULTS: The survey had a 42 percent response rate, and 10 percent of the respondents did not recall being notified of their results. Of the 1556 respondents who recalled being notified, 27 percent contacted the blood center for further information, 60 percent discussed their results with a health care provider, and 73 percent of permanently or indefinitely deferred donors correctly understood their deferral status. Confusion and emotional upset were reported in 81 and 75 percent of notified donors, respectively. CONCLUSIONS: The notification process appears to achieve most of its aims in the majority of donors. Nevertheless, some donors did not understand that they were ineligible for future donation, and many donors were confused and upset. These data indicate that the adverse impact of notifying donors about abnormal test results needs to be considered when new blood donor screening tests and confirmatory algorithms are being licensed and implemented. Further studies of the effectiveness of newer revised donor notification materials are needed.

Adult↗

Risks associated with transfusion of cellular blood components in Canada.

We provide a comprehensive review of risks associated with allogeneic red blood cell and platelet transfusions in Canada. The review focuses on clinically symptomatic noninfectious transfusion risks (acute and delayed hemolytic, febrile nonhemolytic [FNHTR], allergic, volume overload, transfusion-related acute lung injury, graft-versus-host disease, and posttransfusion purpura) and the risk of clinically significant disease from transfusion-transmitted infections. Data sources include information from Canadian Blood Services, Héma-Québec, Health Canada, and the Québec Hemovigilance System as well as published information from research studies and international hemovigilance systems. We estimate that in 2000 the aggregate risk of potentially severe reactions (excluding FNHTR and minor allergic reactions) was 43.2 per 100000 red cell units (95% confidence interval [CI]: 38.7-48.1), affecting 337 recipients, and 125.7 per 100000 platelet pools of 5 units (95% CI: 100.8-154.9), affecting 88 recipients. The most frequent potentially severe outcomes for red cell transfusion were hemolytic reactions and volume overload and for platelet transfusion were major allergic reactions and bacterial contamination. The current risk of human immunodeficiency virus and hepatitis C virus transmission is approximately 1 in 4 million and 1 in 3 million units, respectively. These estimates are useful for decisions concerning transfusion therapy, the informed consent process, and for evaluating efficacy of interventions to reduce risk.

Blood Component Transfusion↗