Prepared for Anything: The Importance of a Safe and Available Blood Supply during Disasters and other Critical Events

Disaster Preparedness in the Blood Bank

Over the past year, many Americans witnessed firsthand the importance of having a safe, available blood supply following a disaster. During the first nine months of 2017, the United States experienced 15 disasters that claimed 323 lives; these disasters were the result of weather and climate.¹ Floods, freezing temperatures, severe storms, tropical cyclones, and wildfires can all impact blood availability. In the event of a natural disaster, issues may arise in which blood donors do not donate, donor centers may become damaged, or donor centers may not have staffing to perform the processing and testing of blood; all of which, result in a disruption of the local blood supply.

Hurricanes can disrupt the blood supply for days. In October 2017, as Hurricane Irma moved across Florida, blood centers serving Florida and the majority of the Southeastern United States were forced to temporarily suspend all blood donations for the safety of the donors and donation center employees and because of the massive damage caused by the hurricane. Proactively, affected blood centers will communicate with blood centers from other parts of the country to arrange for shipments of blood.

In the United States, the epidemic of gun violence is another type of disaster that must be prepared for. A not for profit corporation, Gun Violence Archive, located in Washington, D.C., recorded 15,423 gun related deaths and 30,916 injuries in 2017.² Gun violence occurs throughout the U.S. sometimes involving a single victim, other times more. Recently, in Las Vegas, a mass shooting resulted in the death of 58 people and wounded more than 500 individuals. In response to this tragedy, The American Red Cross provided an additional 450 blood products to area hospitals to support the injured victims.³

With these statistics, the clinical laboratory must have disaster management strategies in place at all hospitals. The Joint Commission (TJC), the Clinical Laboratory Standards Institute (CLSI), the College of American Pathologists (CAP), and AABB all provide either guidelines or standards to assist the laboratory with disaster management and the AABB Standards for Blood Banks and Transfusion Services, requires an emergency preparedness plan for blood bank and transfusion services.⁴ This plan includes policies and procedures as well as emergency communication plans that must be periodically tested with mock disaster drills throughout the year.

Pathogen reduction in platelets: a review of the proposed draft guidance

Having a safe, pure, potent, and effective blood supply is the purview of the U.S. Food and Drug Administration (FDA). The Center for Biologics Evaluation and Research (CBER), within the FDA is responsible for regulating biological products for human use under federal laws. The purpose of CBER is to protect and advance the public health by ensuring that biological products are safe and effective and available to those who need them.^7,8 Over the past decade, one of the greatest risks of transfusion is bacterial contamination of platelets. Platelets are associated with an increased risk of sepsis and are responsible for more transfusion related fatalities than any other blood product.⁹ The Centers for Disease Control and Prevention (CDC) estimates that approximately 1 in 1,000-3,000 platelet units may be contaminated. Because platelets are stored at room temperature there is a much greater risk for the growth of bacteria. In March 2016, the CBER published a draft guidance, “Bacterial Risk Control Strategies for Blood Collections Establishments and Transfusion Services to Enhance the Safety and Availability for Platelets for Transfusion.”¹⁰ The guidance provides recommendations to control the risk of bacterial contamination of platelets through the use of pathogen reduction technology (PRT).

The FDA has cleared two rapid bacterial detection tests, The BacTx (Immunetics, Inc., Boston, MA) and the platelet Pan Genera Detection (PGD) test (Verax Biomedical, Inc., Worcester, MA) for the detection of bacterial contamination in platelets. The BacTx relies on the detection of peptidoglycan which is found in bacterial cell walls.¹¹ The presence of bacteria elicits a reaction, resulting in melanin formation. A photometric change in color represents positive bacterial detection. The Verax test uses an enzyme-linked immunoabsorbent assay to detect the lipoteichoic acid of gram-positive bacteria and polysaccharide antigens specific to gram-negative bacteria.¹² There are additional benefits to PRT. Studies have shown this technology can inactivate not only bacteria but many types of viruses and parasites as well, lowering the risk of transfusion transmitted infections. With emergent diseases, this technology will help avoid further outbreaks such as the Zika virus transmission.¹³

Protecting public health and promoting transfusion safety are the goals of this focus series. Being prepared for the worst possible situations when patients are at their most vulnerable, to support patient care when catastrophic events occur, and having safe blood products available when needed will save lives. This focus series describes how to create a disaster management plan with a review of regulatory requirements as well as a discussion of lessons learned from past disasters. Highlighting the importance of preparing for and responding to bleeding patients, massive transfusion protocols have been revisited to look at the unique transfusion needs of the adult and pediatric patient population. When patients are bleeding they need platelets. Reviewing the FDA guidance for pathogen reduction technology has opened the door to a much safer platelet product, not only by reducing bacteria but other transfusion transmitted infections.