Biovigilance Update - Fall 2014

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FALL 2014

IN THIS ISSUE

AABB Launches Blood Survey »

Patient Safety Organization Informational Webinar to Take Place Dec. 12 »

Study Documents Risk Factors for TRALI Among Inpatient US Elderly »

FDA Official Reviews Fatalities Resulting From Transfusion of Bacterially Contaminated Platelets »

Study Finds No Independent Association Between Blood Transfusion and Overall Survival Rates Following Radical Prostatectomy »

CDC Updates Hemovigilance Module »

Note: Hemovigilance Module Training Webinar Rescheduled for Dec. 9 »

Study Finds Predictors of Hemoglobin Recovery After Initial Successful Donation »

Messages About Vasovagal Symptoms Influence Individuals’ Intentions to Donate Blood »

ICCBBA and GS1 Develop Recommendation to Clarify Appropriate Use of Unique Device Identifiers for HCT/Ps in US »

Technical Experts Meet in Geneva to Discuss WHO Initiative on Medical Products of Human Origin »

AABB and AATM to Partner in Promoting Safe Blood Practices in Asia »

Special Annual Meeting Ebola Session Highlights Practical Information »

US Tops Other Countries in Sickle Cell Alloimmunization Rates »

West Nile Virus Season Winds Down »

AABB Posts Information Piece on Handling Blood Specimens From Suspected Ebola Patients »

CDC Launches Website Nowcasting Spread of Chikungunya in Americas »

Hepatitis E Infections Widespread in Southeast England; Infection Frequency High in French Donations »

Chagas Infection Dramatically Underreported and Undertreated »

Researchers Assess Costs, Consequences and Cost-Effectiveness of Screening US Blood for Babesia »

Chikungunya Arrives in Florida; Puerto Rico Institutes Regulations for Blood Banks; Experimental Chikungunya Vaccine Shows Promise »

TOP NEWS

AABB Launches Blood Survey

During the first week in November, AABB initiated the AABB Blood Survey: Collection, Utilization, and Patient Blood Management to gather information about these important activities in blood establishments in the United States and abroad. The survey covers the period from Jan.1 to Dec. 31, 2013. AABB urges staff at blood collection and transfusion services to complete the online survey between now and the Dec. 15, 2014 deadline. Based on the data collected, AABB will prepare a comprehensive survey report that can be used to inform future benchmarking and the development of evidence-based programs. For every survey completed by the deadline, AABB will provide a complimentary report of the survey findings and analysis and make a donation to the National Blood Foundation in support of early career research. Questions and comments may be directed to the toll-free helpline at +1.800.793.9376 (U.S.), to +1.301.215.6588, or to the AABB Department of Research and Data Analysis.


RECIPIENT HEMOVIGILANCE

Patient Safety Organization Informational Webinar to Take Place Dec. 12

AABB will hold a webinar at 1 pm (ET) on Dec. 12 for those with questions about the AABB Center for Patient Safety, a component Patient Safety Organization, or PSO. AABB's Center for Patient Safety is the only blood transfusion-focused PSO. Members benchmark transfusion reactions, incidents and component utilization with other participating hospitals. During the information session, Barbee Whitaker, PhD, will be available to answer questions about the value, details and benefits of joining. Contact hemovigilance@aabb.org to register.


Study Documents Risk Factors for TRALI Among Inpatient US Elderly

A study by M. Menis et al. published in the September issue of “Transfusion” found a significant increase in transfusion-related acute lung injury, or TRALI, among elderly inpatients who received transfusions containing platelets or plasma or transfusions of five or more units. In addition, the study found that members of this population were more likely to suffer TRALI if they had a history of tobacco use or were female, white or younger elderly — defined as 65 to 79 years of age. Those who previously had suffered hemorrhagic conditions such as purpura; postinflammatory pulmonary fibrosis; pulmonary insufficiency following trauma and surgery; malignant neoplasm of lymphatic and hematopoietic tissue; or neoplasm of uncertain behavior of other lymphatic or hematopoietic tissues were at greater risk, as well. Finally, risk factors also included previous alloimunization including previous pregnancies; blood component transfusions; or tissue, stem cell or organ transplants.

The study, a retrospective analysis of claims recorded in large Medicare administrative databases between 2007 and 2011, is the first population-based investigation to assess TRALI occurrence and potential risk factors among inpatients ages 65 and older. The authors concluded that despite TRALI risk reduction strategies, underlying health conditions, nonimmune mechanisms and prior alloimmunization reactions may still play a significant role in the development of TRALI.


FDA Official Reviews Fatalities Resulting From Transfusion of Bacterially Contaminated Platelets

Salim Haddad, MD, a medical officer in the Food and Drug Administration’s Center for Biologics Evaluation and Research, reported on fatalities resulting from the transfusion of bacterially contaminated platelets. The presentation was part of the National Institutes of Health’s 33rd Annual Immunohematology and Blood Transfusion Symposium held on Sept. 18 in Bethesda, Md. He reported that despite implementation of strategies to reduce the risk of transfusing bacterially contaminated platelets, recipients still face threats including sepsis and death. Haddad recommended that those testing post-storage pools for bacterial contamination avoid surrogate tests such as pH and glucose tests, closely follow each test’s instructions, release product after a minimal hold period and consider using rapid tests. He concluded that the industry needs to maintain effective quarantine control systems and institute a fast notification and retrieval system for contaminated units and associated splits and co-components.


Study Finds No Independent Association Between Blood Transfusion and Overall Survival Rates Following Radical Prostatectomy

A study of radical prostatectomy patients in the September issue of “Transfusion” found no independent association between blood transfusion — either autologous or allogeneic — and long-term prostate cancer recurrence or survival after controlling for confounding clinical variables. Researchers H.J. Chalfin et al. performed a retrospective cohort analysis on patients who underwent radical prostatectomy between 1994 and 2012. They examined three groups: those who received no blood transfusions, those who received only autologous transfusions and those who received any allogeneic transfusions. When the researchers controlled for confounding factors such as advanced age and higher preoperative PSA levels, they found that a previous univariate association between allogeneic blood transfusion and decreased overall survival disappeared. The researchers’ findings suggest that transfusion does not increase the risk of prostate cancer recurrence or decrease survival rates among radical prostatectomy patients.


CDC Updates Hemovigilance Module

The Centers for Disease Control and Prevention has migrated away from issuing digital certificates to access the National Healthcare Safety Network, or NHSN, and the Secure Access Management System, or SAMS, will take its place. CDC stopped issuing digital certificates as of September 2014. All new users will be invited to apply for SAMS credentials, and current users with digital certificates also will be invited to apply for SAMS credentials before their digital certificates expire. CDC recommends users act promptly once they receive a SAMS invitation, as the process is significantly different from the digital certificate process. The “SAMS Registration Steps” quick guide is available on the Hemovigilance Module website under the Supporting Materials Section. For detailed information regarding SAMS, visit the SAMS website.

In addition, CDC has updated the NHSN Biovigilance Component home screen. The tabs for Missing Incident Summary, Incident Summary and Events Entered, and Missing High Priority Incidents have been removed from the alerts screen. Also, users can add missing Adverse Reaction and Incident forms directly from the alerts screen now.

As 2014 comes to an end, CDC reminds facilities to address any missing data for the year. Send questions and feedback to nhsn@cdc.gov and include “Biovigilance” in the subject line for the fastest response.


Note: Hemovigilance Module Training Webinar Rescheduled for Dec. 9

The CDC’s November Hemovigilance Module training webinar has been rescheduled for Dec. 9 from 2:30-3:30 pm (ET). The webinar will address NHSN Biovigilance Component home screen alerts, the Incomplete/Missing Lists and data entry completion for 2014. The registration page for the webinar is available on the NHSN website. The CDC asks those with questions to email nhsn@cdc.gov and include “Biovigilance” in the subject line.


DONOR HEMOVIGILANCE

Study Finds Predictors of Hemoglobin Recovery After Initial Successful Donation

B. Custer et al. found in a study in the September issue of “Transfusion” that index hemoglobin, or Hb, level was the factor most strongly associated with blood donors’ recovery to predonation level. The researchers measured Hb levels of allogeneic first-time blood donors who successfully donated red blood cells at an initial index donation and returned for a second donation between Aug.1, 2009 and July 31, 2012. Multivariable logistic regression methods showed that higher rates of recovery to predonation Hb levels were most highly associated with lower index Hb levels, although lower index levels also were associated with increased donor deferrals, especially of those donors with index levels near the current Hb cutoff of 12.5 g/dL. In addition, the analysis showed that males had a higher likelihood of recovery than females, and whites were more likely to recover than blacks. The authors concluded that there appear to be two distinct donor populations with similar characteristics — those who are able to recover quickly to initial Hb level and those who are not — and that demographic and donation characteristics alone are not sufficient to distinguish between the two groups. In addition, biologic factors, such as iron absorption rates and metabolism, seem to play an important role.


Messages About Vasovagal Symptoms Influence Individuals’ Intentions to Donate Blood

In a September “Transfusion” study, J. P. Rose et al. found that college students expressed greater intentions of donating blood in the future when researchers gave them statistics on the low probability of experiencing vasovagal symptoms after a donation. The researchers conducted three studies to assess participants’ beliefs about how many blood donors develop vasovagal symptoms, such as dizziness and nausea. All of the study participants overestimated the percentage of blood donors who experience these symptoms, and those who had never donated blood had higher estimates than those who had. The study also showed that the framing of messages about the prevalence of vasovagal symptoms affected participants’ fear of developing the symptoms and intentions to donate blood in the future. The authors concluded that researchers, practitioners and recruiters should be aware of the tendency to overestimate the probability of vasovagal symptoms, try to correct this biased perception and keep the role of message framing in mind when developing health communications.


GLOBAL BIOVIGILANCE

ICCBBA and GS1 Develop Recommendation to Clarify Appropriate Use of Unique Device Identifiers for HCT/Ps in US

GS1 and ICCBBA released a guidance document that recommends the use of the ISBT 128 Standard to identify medical devices that contain human cells, tissues and cellular and tissue-based products, or HCT/Ps. The recommendation applies to HCT/Ps that are regulated as medical devices in the U.S. under the FDA’s Unique Device Identifier System Final Rule. The rationale that applies to the use of ISBT 128 for tissues regulated as medical devices applies equally to its use for traditional tissues. Therefore, ICCBBA also encourages the use of ISBT 128 for tissues regulated as biologics to provide a consistent means of coding all tissue for transplantation. The document notes that ISBT 128 was designed to account for traceability requirements of HCT/Ps and so that the use of globally unique donation identification numbers, supported by universally harmonized terminology and coding, ensure that donations can be traced to the donor.


Technical Experts Meet in Geneva to Discuss WHO Initiative on Medical Products of Human Origin

Experts on medical products of human origin, or MPHOs, met in Geneva on Sept. 15-16 to discuss the World Health Organization’s initiative to develop a global harmonization for the products. MPHOs, defined as all substances that are derived wholly or in part from the human body and intended for human application, include blood, organs, bone marrow, cord blood, corneas, tissues, reproductive cells and milk. The initiative’s goal is to create a universal unifying concept for MPHOs that increases donations and preserves societal values and donor dignity.

MPHOs have been fragmented into subclasses that are treated differently in many different places. To address the issue, the initiative proposes extending the WHO’s “Guiding Principles on Human Cell, Tissue and Organ Transplantation” to create a set of core principles that apply to the full range of MPHOs. The principles are to be realized over time through public education while regulatory structures, legislation and clinical practices are developed and implemented. The initiative also includes specific objectives, such as developing a common language and consistent coding, and the group is working to promote universal adoption of the Information Standard for Blood and Transplant, or ISBT, 128 system within 10 years.

In addition, the initiative’s Notify Project, a global interface created jointly by the WHO and the Italian National Transplant Centre, promotes global vigilance and surveillance of MPHOs. The project’s Notify Library is a database of adverse reactions resulting from the procurement, processing and clinical application of MPHOs. The library serves as a reference for professionals involved in research and diagnostics, donor and recipient selection and quality risk management. Paul Ashford, BA, MSc, CEng, CSci, the executive director of ICCBBA — the international standards organization responsible for the development and management of the ISBT 128 Standard — reports progress in the adoption of terminology at local, national and international levels and growing support for its use among scientific and professional societies. AABB’s Barbee Whitaker, PhD, director of research and data analysis, and Kathy Loper, MT (ASCP), cellular therapies director, are part of the working group that has been developing the new taxonomy and working methods for the library.

José Ramon Nuñez Peña, MD, has replaced Luc Noël, MD, at the WHO as the leader of the MPHO initiative. Noël, who retired at the end of August, had overseen the initiative in addition to cell, tissue and organ donation and transplantation. He had been with the WHO since 1999, when he was appointed coordinator of blood transfusion safety.


AABB and AATM to Partner in Promoting Safe Blood Practices in Asia

The leadership of AABB and the Asia Association for Transfusion Medicine, or AATM, announced the signing of a memorandum of understanding aimed at promoting common goals in transfusion medicine and cellular therapies. The organizations plan to work together to hasten the adoption and dissemination of standards and accreditation programs for blood use and cellular therapies in Asia. The team intends to offer training courses and online education to advance patient and donor safety and care; other programs under consideration include wet workshops and fellowships for young professionals. An announcement of the partnership is available online.


HEMOVIGILANCE AT AABB ANNUAL MEETING

Special Annual Meeting Ebola Session Highlights Practical Information

Providing convalescent plasma to treat Ebola patients in the U.S. requires an emergency investigational new drug, or eIND, application from the FDA according to clinicians during the “Ebola and Transfusion Medicine” hot topics session at the AABB Annual Meeting. “The eIND that you submit encompasses collection and transfusion of convalescent plasma, and it’s specific for a donor and recipient,” said Annie Winkler, MD, of Emory University. Patients in the U.S. with Ebola virus disease, or EBV, were treated successfully at Emory University Hospital and the Nebraska Medical Center, two of the four high-level biocontainment patient care units in the U.S.

While the session focused primarily on practical tips from those who have treated EVD patients, session moderator Aaron Tobian, MD, PhD, highlighted the efforts of AABB’s newly-formed Ebola Policy Working Group. This group is tasked with producing and disseminating template documents for convalescent plasma eIND applications. The eIND template package will include the following information: a list of critical government contacts; the minimal data required for FDA form 1571; template donor and recipient consent forms; and lists of collection facility minimal screening, testing and infection control requirements. Dr. Tobian noted that the working group also is working with the FDA on creating an “umbrella” multicenter IND protocol that avoids the necessity of repeatedly evaluating individual institution eIND protocols.


US Tops Other Countries in Sickle Cell Alloimmunization Rates

Patients with sickle cell disease, or SCD, in the U.S. appear to have a significantly higher rate of alloimmunization compared to patients in South America, the Middle East, Africa and Europe, according to a meta-analysis presented during the AABB Annual Meeting. The alloimmunization rate for patients in the U.S. was 23 percent compared with 17 percent in non-U.S. countries, Yan Zheng, MD, and Robert Maitta, MD, PhD, reported. U.S. patients had a significantly greater number of alloantibodies per person (0.3) compared with patients from other countries (0.2).

The researchers analyzed studies of alloimmunization rates of patients with SCD from 1971 to 2012 and divided the data based on country of origin. They identified 16 studies including 3,609 patients from the U.S. and eight studies with a total of 2,088 patients from other countries. The researchers proposed several possible explanations for the high alloimmunization rates observed in the U.S. Zheng suggested that the overuse of red blood cell, or RBC, transfusions in the U.S. could lead to greater RBC exposure in terms of dosage and frequency. In addition, the U.S. may have better alloantibody detection techniques. Finally, racial compatibility between SCD patients and blood donors could play a role. In the U.S., almost all SCD patients are black while most blood donors are white. There may be less of a mismatch in other countries, for example Brazil, where almost half of SCD patients and more than half of donors are of mixed race.


TRANSFUSION-TRANSMITTED INFECTIONS

West Nile Virus Season Winds Down

As winter approaches and the 2014 West Nile virus season draws to a close, blood collection facilities are encouraged to update any suspected reactive reports in AABB’s WNV Biovigilance Network with their final designations. The network provides data on presumed and actual WNV-infected donations by week and by postal code in the U.S. and Canada. AABB recommends that blood collection and testing facilities use data from the network to determine when to change from minipool testing to individual donation nucleic acid amplification (NAT) testing.

In August, AABB initiated an email system to alert those on the WNV laboratory contacts list when a blood center enters a new suspected viremic donation into the network. The email messages include the donation date, the donor’s home zip code, the signal/cutoff value (if available) and the final test interpretation.

In 2014, from the beginning of the year through Dec. 1, there have been 301 confirmed positive viremic donations and 56 presumed viremic donations that are awaiting test interpretation.


AABB Posts Information Piece on Handling Blood Specimens From Suspected Ebola Patients

To address concerns within the transfusion community about the outbreak of Ebola virus disease, or EVD, in early September AABB posted an information piece developed by the AABB Clinical Transfusion Medicine Committee. The document provides information regarding EVD and precautions to take to control infection when collecting and handling blood specimens. AABB urges facilities working with these specimens to follow the CDC’s Food interim guidance and to review the CDC’s Ebola Web page frequently. A more detailed description of the CDC guidance appears in the piece.


CDC Launches Website Nowcasting Spread of Chikungunya in Americas

The CDC initiated a website on Oct. 6 that will identify where and when the chikungunya virus is likely to spread in the Americas. The nowcasting site is based on a CDC-developed mathematical model that predicts locations where local transmission of the virus are likely to occur — before or at the same time officials receive the first reports of chikungunya virus disease. The new website will enable health officials to implement proactive prevention and control activities and thus limit the effect of the virus.


Hepatitis E Infections Widespread in Southeast England; Infection Frequency High in French Donations

Researchers in the United Kingdom estimated the prevalence of hepatitis E virus, or HEV, infection to be one in 2,848 blood donations in southeast England. The finding comes from a one-year study of 225,000 individual donations reported in “The Lancet.” When projected across England, the estimate sets the prevalence at 80,000 to 100,000 acute HEV infections between 2012 and 2013 (see accompanying comment). Although 79 infected donors were viremic for genotype 3 HEV, most of them were seronegative at the time of donation. In all, 129 blood components were prepared from these donations, and 62 were transfused to 60 patients before the infected donation was identified. Follow-up of 43 of these individuals revealed a varied response to infection that reflected the patient’s “overall clinical state and inferred degree of immunosuppression.” Notably, time to seroconversion and duration of infection appeared to increase as severity of immunosuppression increased.

In a separate study reported in “Emerging Infectious Diseases,” researchers estimated the prevalence of HEV infection to be one in 2,218 in France. French researchers screened 53,234 samples for HEV RNA using nucleic acid amplification. All HEV strains were genotype 3. Infections were overwhelmingly detected at an early stage, with serologic markers absent in more than 90 percent of cases.


Chagas Infection Dramatically Underreported and Undertreated

One in every 6,500 Texas blood donors showed positive test results for Chagas infection between 2008 and 2012, according to recently published data highlighted at the annual meeting of the American Society of Tropical Medicine and Hygiene. The researchers from Baylor University also documented 17 Houston-area residents who were confirmed positive for antibodies to Trypanosoma cruzi. Forty-one percent of the residents, who were monitored for Chagas-associated cardiovascular manifestations, exhibited an electrocardiographic abnormality consistent with Chagas cardiomyopathy. More than a third of cases were presumed to be locally acquired.

In a separate study also presented at the meeting, researchers in Boston found that only 422 out of 1,908 individuals identified as positive for Chagas through blood donation testing received medications for the infection between 2007 and 2013. The findings were based on a new analysis of data from the CDC and AABB. Currently, benznidazole and nifurtimox — which are not approved to treat Chagas in the U.S. — are only available only from the CDC under compassionate use protocols. The researchers concluded that the findings highlight a large treatment gap.


Researchers Assess Costs, Consequences and Cost-Effectiveness of Screening US Blood for Babesia

A study by A. J. Goodell et al. in the September issue of “Transfusion” compared five different modes of testing blood for Babesia microti in four different geographic areas and found that the cost of targeted screenings in states with the highest seroprevalence of the parasite exceeded the implicit blood-safety threshold of $1 million per quality-adjusted life-year. Using a decision analytic model to estimate direct costs and consequences of donor screening versus recipient infection, the researchers simulated the outcomes of B. microti infection and survival of the transfused population and estimated seroprevalence, test performance and transmissibility. Based on the low transmissibility of B. microti and the short acute course and low mortality associated with babesiosis, the study showed that even the most focused strategies may not achieve a cost-effectiveness comparable to other high-cost screening methods, such as tests for HIV and hepatitis C virus and seasonal screenings for West Nile virus.


Chikungunya Arrives in Florida; Puerto Rico Institutes Regulations for Blood Banks; Experimental Chikungunya Vaccine Shows Promise

Public health officials confirmed the first two cases of Chikungunya virus, or CHIKV, transmission in the continental U.S., according to an article in the “Journal of the American Medical Association.” The cases were recorded in Florida in mid-July; by then, the CDC had reported 234 diagnoses of the virus in U.S. travelers to the Caribbean and Central and South America. Public health authorities had anticipated the arrival of the virus in the continental U.S. since the WHO reported its first transmission in the Caribbean in December, 2013. Officials reportedly expect CHIKV to continue spreading in the continental U.S., based on the 2013 spread of dengue virus, or DENV, which is transmitted by the same vectors.

In Puerto Rico, the Department of Health began requiring all registered blood banks to take precautionary steps in August to reduce the risk of transfusion transmission of CHIKV, as well as DENV. The steps include asking donors if they have experienced fever; headache; muscle, joint or bone pain; or rash in the past seven days or if anyone in their home or neighborhood has been diagnosed with CHIKV or DENV during the same period. Administrative Order No. 328 (in Spanish) lists the requirements, which include enhanced education for post-donation symptoms and a 72-hour product quarantine period to allow for collection of post-donation information from the donors. The Pan American Health Organization reported 3,287 confirmed cases of CHIKV in Puerto Rico as of Nov. 21, 2014.

On August 25, the National Institutes of Health reported that an experimental CHIKV vaccine provoked immune responses in all 25 subjects in an early-stage clinical trial. There are currently no approved vaccines or treatments for the virus.