Ensuring that blood to be used for transfusions is safe is a multistep process that begins in the blood bank and does not end until the transfused patient is discharged from the hospital without having suffered any adverse events directly related to the blood supply. This raises a number of challenges — not the least of which is guaranteeing an adequate supply of blood.
Tim Costello, director of marketing for Somerset, NJ-based Terumo Medical Corp., says it is getting harder to find a viable supply of donors. As the general population ages, those senior citizens who regularly donated blood out of a sense of civic obligation, are now the most likely to need transfusions, he says.
Testing for diseases
Helping to contribute to the shortage of donors are the stringent regulations set forth by the U.S. Food and Drug Administration (FDA). As examples of current policy, Costello points to potential donors who must wait 12 months to 16 months after getting a piercing and the total ban on all gay men, even if they test negative for HIV. Donors also are deferred “if they travel to areas in the world where diseases like malaria are common,” he says.
The FDA’s five-prong approach to ensuring the safety of America’s blood supply includes donor screening; blood testing; compiling lists of donors; the quarantine of all blood before it is tested; and the immediate correction of all deficiencies or malfunctioning equipment in blood centers. As for blood testing, the FDA requires all units be tested for hepatitis B and C viruses, HIV-1 and 2. and syphilis. Last year, however, Transfusion, the official journal of the AABB, published a supplement detailing 68 emerging infectious-disease agents and their potential threats to blood transfusions. Included were West Nile virus, H1N1, and the dengue virus.
the FDA requires all units
be tested for hepatitis B and
C viruses, HIV-1 and 2
and syphilis.
Providers of equipment and services to laboratories are well aware of the challenges facing those who collect and process blood. Joe Sanders, vice president of marketing and business development for Worcester, MA-based Verax Biomedical, says bacterial growth in collected blood poses a threat that could prove fatal. Limited mainly to staph and strep bacteria that enter the bag when blood is collected, nearly one in 2,000 bags may be contaminated. Current methods used to test blood shortly after collection often miss the presence of bacteria. “Seventy to 75% of the time these tests give false negatives. But these bacteria can bloom out in a bag during storage,” he says.
Concern also has been raised as to how often transfusions should be ordered, says Barbara Connell, senior manager for scientific marketing at Sysmex America in Mundelein, IL. “Blood is good, but blood is bad,” she says, explaining that blood can be a lifesaver when it is needed but also can cause undue complications if transfusions are viewed simply as a standard operating procedure for most surgeries. And questions are even being asked as to how long red blood cells can be stored prior to transfusing.
In June, the U.S. National Institutes of Health announced a multicenter, randomized clinical trial that will compare outcomes in heart-surgery patients who were transfused with red blood cells stored for various lengths of time. The trials will be led by Marie Steiner, MD, a University of Minnesota Medical School associate professor, and will be conducted at selected hospitals across the country including New York, Boston, Baltimore, Atlanta, Seattle, and Durham and Chapel Hill, NC.
Janet Molny, owner and president of Ronkonkoma, NY-based Validation Partners, says her company offers a national patient antibody registry to blood banks. As a patient search engine, this software highlights positive antibody test results so subscribing blood banks can facilitate antibody screens for patients who may have visited other facilities, she says.
AABB requires that all platelets be tested for bacterial contamination, Sanders says. But now they are recommending the elimination of all surrogate tests. In keeping with this trend, Verax offers a test for whole blood-derived platelets that detects bacteria in both pooled and single-donor platelets with results available in about 30 minutes, Sanders says.
Similarly, Sysmex America concentrates on cell counting, says Connell. One of its hematology analyzers can count up to 5 million platelets per cubic microliter, she says.
A challenge her company currently is confronting is “finding an efficient way to count white blood cells in leuko-reduced RBC or platelet products.” She says, “Today, these counts are performed using manual Nagette counts. But that is time consuming and labor intensive. We are trying to find an automated way to do those counts. But it would need to count very low numbers.”
Quality control
According to Connell, the FDA is also requiring more quality control on blood collected for transfusions. As a result, blood banks putting in place additional policies and procedures to ensure the safest supply of blood possible.
“The blood bank has been one of the last organizations to get
automated … It is the last bastion of manual testing.”
Tim Lozier, marketing manager at Farmingdale, NY-based EtQ, says his company has developed an FDA-compliance software solution that is Web-based but with offline capability. Modules include change management, calibration and maintenance, corrective and preventive actions, and employee training. In the case of adverse events, Lozier says, the software filters out the most critical events first.
The importance of monitoring lab equipment has led Raritan, NJ-based Ortho Clinical Diagnostics to develop a 24/7 remote monitoring system for its own product lines, says Susan Kadri, vice president of transfusion medicine, worldwide. Using a broadband Internet connection, data exchanged is securely encrypted via a VPN. “We know when something will go wrong, then schedule maintenance time,” she says.
Reducing errors to ensure patient safety is as much a part of giving blood as it is prescribing and administering standard medications. A major trend today, says Lori Giannetta, director of operations for Trumbull, CT-based Korchek Technologies, is the use of bar codes on blood bags and patient wristbands. With and increasing number of procedures moving to the point of care, Giannetta says her company has developed both a wired and wireless hand-held device for use at the bedside before a transfusion begins. Not only does the device match the patient with the blood product, but it also documents any and all adverse events. “But we are taking it one step further,” she says. “The scanning also allows vital signs to be captured at the bedside.”
Advancing automation
As with most other types of laboratories, blood banks are slowly moving toward automation. “The blood bank has been one of the last organizations to get automated,” says Michael Garver, applications specialist at Psyche Systems Corp. “It is the last bastion of manual testing.” But he notes that the trend is to make things simpler. “The more complex the system, the more complex the validation,” he says.
John Bussell, division manager of DiaMed GmbH, now a division of Bio-Rad, agrees. “One of the key trends will continue to be increased automation in the laboratory,” he says. But he adds, “One half of the U.S. market is still based on conventional reagents, which is manual.”
Bussell also sees a trend toward more sophisticated blood typing tests. “No one in blood typing would deny a trend toward molecular genotyping when you are trying to find unique donors. We do not believe this will replace conventional methods, but it will be an adjunct.”
Richard R. Rogoski is a freelance journalist based in Durham, NC. Contact him at [email protected].
