Blood you can trust: global trends in transfusion safety

Certain challenges in blood banking and transfusion medicine are shared globally. For example, blood banks have improved their strategies to recruit donors, identify and retain donors with rare blood types, and better deliver the blood types that will be needed to serve their blood recipient population. Countries have continued to expand and share their expertise on the development of robust quality systems, an important part of any transfusion safety program. In developing a strong quality system, laboratories must address complex elements that range from regulatory requirements to process control; from validation of equipment, vendors, and processes to set up, training, and ongoing proficiency testing of laboratory staff. Access to this specialized know-how, as well as funding, can make it a challenge to implement sustainable quality programs, especially in countries with limited resources and strong competing public health concerns. Policy makers and transfusion medicine specialists have played an essential role in protecting patients and improving public health with widespread use of molecular testing (also called nucleic acid technology or NAT) to improve detection of serious viral diseases such as HIV and hepatitis. Newer automated platforms with expanded test menus make the use of NAT in tandem with traditional serology to identify and remove infected units of blood from the blood supply increasingly manageable and reliable for laboratories. Today, most countries have increased the safety of their blood supplies by implementing stringent policies and quality standards with comprehensive nationwide testing strategies that employ both NAT platforms and serology. Two well-known examples highlight the value of strong donor history screening and infectious disease testing strategies. Patients in the United States in the 1960s faced a nearly one in four chance of acquiring hepatitis during a blood transfusion. Today, that risk is virtually zero, and the U.S. blood supply is among the safest in the world.² In 2011, the South African National Blood Service (SANBS) celebrated five years of success preventing HIV and hepatitis transmission from donated blood.³ Ravi Reddy, chief operations officer at SANBS, noted that, prior to use of nucleic acid testing of each individual blood donation (called ID-NAT), “transmission of HIV and hepatitis infections from donated blood was not uncommon in South Africa.”

Reducing human error

In 1992, R.S. Markin outlined new concepts, challenges, and requirements for bringing robotics and automation from industrial and other applications to the clinical laboratory.⁴ Today, driven by changing market needs, lab directors expect—and companies invest millions to deliver—improved automation, ease of operation, and more sophisticated data handling with each new generation of product. The need to reduce human error through automation in these areas is legitimate. Since 1996, the UK’s SHOT (Serious Hazards of Transfusion) hemovigilance program has been collecting and analyzing information on UK blood transfusion adverse events and reactions. The Annual SHOT data for 2014 consistently demonstrates human error to be the largest cause of adverse transfusion incidents.⁵ In addition to re-defining processes to reduce or eliminate human error, hospitals around the world are exploring the use of systems employing bar codes and hand-held computers to scan and track all patient blood specimens, transfusion  components, and the transfusion event itself.⁶ Improving compatibility Blood banks and hospital transfusion centers still face challenges to ensure that patients, especially those who are multiply or chronically transfused, receive blood that is safe and compatible. To address their needs, experts are increasingly recognizing the value of molecular testing on standard blood samples or buccal swabs. Molecular techniques have enabled rapid developments in the field of immunohematology, building on the early-twentieth century identification of blood groups A, B, O, and AB and identification of the Rh blood group system in the 1940s. According to Paul Ness, MD, at Johns Hopkins University, increasing knowledge of the Rh blood group and DNA-based molecular techniques have enabled new approaches to Rh typing—especially in the identity of specific D- variants that allow the use of Rh immune globulin to be prescribed more judiciously.⁷ Joann Moulds, PhD, director of an immunohematology center in Texas, notes that blood group genotyping can enable better decisions about which type of blood to use for particular patients and can help resolve diagnostic transfusion dilemmas. She notes that case studies illustrate how red blood cell or platelet genotyping can be useful in patients who have had recent transfusions, patients whose red blood cells are direct antiglobulin-test positive, patients with sickle cell disease, and patients who are pregnant.⁸ Dr. Moulds also notes that neither serology nor genotyping are perfect diagnostic methods and that they are not equivalent. Each method offers valuable information and, when taken  together, they provide a more complete clinical picture. Safety and compatibility will always remain at the top of the minds of transfusion specialists. New technologies, improved processes, close collaborations, and ongoing investigations in research and development all promise a future of continued  development in this vital healthcare segment.

References

1. Roback JD (ed). Non-infectious complications of blood transfusion. Chapter 27, AABB Technical Manual. 17th edition. AABB, Bethesda, 2011.
2. U.S. Food & Drug Administration website. Keeping blood transfusions safe: FDA’s multi-layered protections for donated blood. http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/BloodSafety/ucm095522.htm. Accessed August 31, 2015.
3. Press release, South Africa National Blood Service. “New data from SANBS reinforces 5 years of success preventing HIV and hepatitis transmission from donated blood.”http://www.prnewswire.com/news-releases/new-data-from-sanbs-reinforces-5-years-of-success-preventing-hiv-and-hepatitis-transmission-from-donated-blood-126109783.html. Accessed via PR Newswire August 31, 2015.
4. Markin RS. Laboratory automation systems. An introduction to concepts and terminology. Am J Clin Pathol. 1992;98(4 Suppl 1):S3-10.
5. SHOT website, www.shotuk.org. Accessed August 31, 2015.
6. Transfusion Safety: Key Elements & Management, Dr. Miguel Angel Vesga Carasa, Blood Transfusion and Human Tissue Center of the Basque Country (Spain) as presented at the International Haemovigilance Seminar, 5-7 March 2014 (Barcelona, Spain).
7. Paul M. Ness, MD. “Historical Overview of Transfusion Medicine” as presented at the AABB Annual Meeting Grifols Corporate Educational Symposium, October 27, 2014.
8. Joann Moulds, PhD. “Blood Group Genotyping: A New Tool to Resolve Patient Problems,” as presented at the 33rd International Congress of the International Society of Blood Transfusion, May 31-June 5, 2014, Seoul, South Korea.