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||October 6, 2009|
||Jay E. Menitove, MD – President|
Karen Shoos Lipton, JD – Chief Executive Officer
||Pandemic Influenza Update |
In light of events surrounding the pandemic of novel H1N1 Influenza A since the spring of this year, AABB has made revisions to related planning documents and checklists on the AABB Web site
(http://www.aabb.org/Content/Programs_and_Services/Disaster_Response/disastercontact.htm#3). This bulletin highlights important recent developments and changes to these documents.
Association Bulletins, which are approved for distribution by the AABB Board of Directors, may include announcements of standards or requirements for accreditation, recommendations on emerging trends or best practices, and/or pertinent information. This bulletin contains information only.
Influenza Vaccines: Several inactivated trivalent seasonal and pandemic influenza vaccines will be administered in the United States this season
(http://www.cdc.gov/flu/professionals/vaccination/index.htm). Also, two intranasal live-attenuated flu vaccines – a trivalent seasonal vaccine and a vaccine against the novel H1N1 pandemic strain – have been approved by the Food and Drug Administration (FDA) for use. The intranasal live-attenuated flu vaccines do not require deferral from donation. This bulletin supersedes Association Bulletin #03-13, Intranasal Flu Vaccine - FluMist™, which was specific for a particular vaccine.
The members of the AABB Interorganizational Task Force on Pandemic Influenza and the Blood Supply (Task Force) and the Transfusion-Transmitted Diseases Committee have discussed the available vaccines and consulted with FDA representatives on any affect the receipt of these vaccines may have on blood donors. All of the vaccines being distributed in the United States this season are being regulated by FDA as strain changes that are developed and manufactured exactly as prior seasonal vaccines have been. They are not considered to be investigational; therefore, there is no requirement for donor deferral under the 25th or 26th editions of AABB Standards for Blood Banks and Transfusion Services (Reference Standard 5.4.1A). Blood collection facilities with standard operating procedures (SOPs) that require such deferrals may wish to change their SOPs. Such changes may be included in each facility’s annual report to FDA. There are adjuvant vaccines undergoing evaluation that are investigational. Reference Standard 5.4.1A requires a 12-month deferral for receipt of these vaccines “unless otherwise indicated by the medical director.”
Symptomatic Workers and Donors: The Task Force has received inquiries regarding requirements for exclusion from donation or work of individuals recovering from influenza and influenza-like illnesses. Although published and unpublished reports have noted the detection of influenza viral nucleic acids in nasal secretions beyond 24 hours after resolution of fever in flu patients, the infectivity of these individuals has not been established.
The Centers for Disease Control and Prevention (CDC) have recommended that health-care personnel who develop a febrile respiratory illness should be excluded from work for seven days or until symptoms have resolved, whichever is longer (http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm). In the non-health-care setting, the recommendation is for affected individuals to remain at home until they are fever-free for 24 hours without antipyretics (http://www.cdc.gov/h1n1flu/guidance/exclusion.htm). Although the Task Force has identified donor collection personnel as health-care workers, the Task Force also recognizes that donor center personnel are not routinely coming into contact with the patient population. In the donor room setting, clinically ill donors and staff should be excluded. Therefore, the Task Force recommends that, at a minimum, in the routine donor room setting, the return to work should not occur until fever is resolved for 24 hours, without antipyretics, and respiratory symptoms are substantially improved. Each facility should have a policy about both return to work of staff and acceptance of donors who have recovered from influenza or influenza-like illness. Hand hygiene and cough etiquette remain critical (http://www.cdc.gov/flu/professionals/infectioncontrol/resphygiene.htm).
Personal Protective Equipment (PPE): Additional PPE beyond that required by local SOPs is not necessary when appropriate exclusion of ill people is enforced. Specific guidance from CDC for donor centers is being formulated and should be consulted routinely because this information is subject to change over time.
Monitoring Blood Inventory: Blood collection facilities should closely monitor blood component supplies, both within their facilities and at the hospital transfusion services they supply, and take steps to meet changes in demand. Although during a pandemic, demand for blood components may decrease, transfusion services should have plans to reduce non-urgent and emergent transfusion in the event of shortages. Facilities should also be prepared for possible surges in demand immediately following a pandemic.
Public Messages: Facilities should use messages consistent with the Task Force’s messages should they be developed. Pandemic hysteria should not be used as a recruitment tool.
Coordination with State and Local Public Health Officials: In preparing for and responding to a pandemic, it is critical that blood collection facilities maintain close relationships with state and local public health officials to coordinate public messaging to promote continued blood donation in the event blood inventories are at risk of disruption. In addition, facilities should be in contact with these public health officials regarding prioritization of H1N1 vaccines for essential blood center personnel, because vaccine distribution decisions are made by state authorities.
As circumstances unfold, the Task Force will respond to new information from FDA and other sources and seek clarification when appropriate about permissible variations to routine donor and collection processes that may become necessary in the event of a pandemic. Updated information will be posted on AABB’s Web site.