RIDING THE BOW WAVE OF AUTOMATION
BLOOD BANKING COMMUNITY IS BENEFITING FROM NEW INSTRUMENTS AND SYSTEMS
Automated blood banking has come a long way in the last 10-to-15 years, reflected Lieutenant Commander Corey Jenkins, director, Armed Services Blood Bank Center, National Capitol Area.
The facility is a blood donor center which collects blood for internal DoD use. Following U.S. Food and Drug Administration (FDA) laws, “we test every unit of blood for many things, including ABO/Rh, anti-body screen, hepatitis, HIV and syphilis,” he pointed out.
Only a recent course change has allowed the center to ride the bow wave of automation that is sweeping through other DoD medical facilities and programs. “Up until a few years ago, everything was done manually in the blood bank—it was all done in a test tube,” Jenkins recalled.
As other DoD blood banking facilities are including automated system solutions in their laboratories, automation is also supporting processes and instruments for blood collection systems in fixed-site hospitals and deployed units on the battlefield.
APPLICATIONS
There are two automated technologies used by U.S. DoD medical laboratories and the broader blood donor industry.
The capture method is the technology foundation for instruments such as Immucor’s Galileo Automated Blood Bank System, which is used at the Armed Services Blood Bank Center. “This suits facilities which do a lot of work, like batching a lot of samples at one time,” opined Jenkins.
As a reference point, the Armed Services Blood Bank Center may conduct 200 samples at one time for several different tests. However, to ensure high standards of quality assurance, these same samples are then tested two additional times for ABO and Rh type. “When we do the ABO and Rh test, we do it several times on the same sample,” pointed out Jenkins. He added, “If you kill someone through a blood bank, it’s because you gave them the wrong type of blood, so we check and double check the ABO and Rh of every unit that is collected,” he emphasized.
By comparison, the Galileo instrument can process up to 224 different samples at once, stated the Immucor homepage.
An additional Galileo capability being fielded is a test for syphilis. The FDA cleared Immucor’s Capture S (Syphilis) and CMV assays for use on Galileo in April 2006.
Another DoD medical facility, Naval Hospital Okinawa, recently took a step to further automate its laboratory when it issued a combined solicitation for a Galileo system and an accompanying Capture Workstation.
A second automated technology is based on a Gel Test. This capability is the basis of Ortho-Clinical Diagnostics’ ProVue instrument.
“When you look at a transfusion service, where it takes one sample at a time, then this method becomes more intriguing,” said Jenkins.
The instrument provides another insight on how automation is transforming blood banking. The company homepage states “recent studies showed that, on average, one Ortho ProVue operator did the serologic testing previously performed by two technical staff members— while reducing the total processing time by 40 percent. The research also showed an 81.6 percent overall handson time reduction compared to manual tube testing—and a 75.9 percent reduction when compared to manual gel testing.”
Automated instruments and systems also provide blood banking support for service men and women in harm’s way.
COMBAT MEDICINE ENHANCER
Combat medicine, including transfusion medicine, can differ dramatically from civilian trauma medicine, pointed out Julie Fallon, Haemonetics spokesperson. “For example, in civilian transfusion medicine, doctors more often transfuse a blood component (platelets, plasma or red cells) rather than whole blood so that the patient is treated with only the blood component clinically indicated for his or her medical need,” she said. Fallon further explained, “For example, red cells are often used to treat patients in high blood loss, trauma cases. Conversely, whole blood transfusion is done in a combat environment. However, by using Haemonetics’ technology, the military has been able to increase its supply of platelets in theater and have dramatically reduced the use of whole blood.”
The company’s equipment, consumables, IT software and business solutions can be found in military hospitals, blood collection centers, Cryo Labs, Armed Services Whole Blood Processing Labs, frozen blood depots, and the Navy’s amphibious assault vessels, and as standard equipment with deployable detachment units.
One instrument is Haemonetics’ MCS automated blood collection system that allows for the collection of more blood from existing donors to ensure that enough blood, and the right type of blood, is available for service men and women.
The company markets its MCS systems to the military. The systems automate the blood donation process, resulting in a higher yield of the blood components prescribed by physicians for different clinical indications. In addition, the MCS systems are portable, so blood components can be collected in mobile, deployed units as well as in fixed site military hospitals.
“The MCS systems also automate many of the manual blood processing steps associated with whole blood collection,” noted Fallon. “Automation supports blood processing efficiency, blood component quality and good manufacturing practices, and reduces blood processing space requirements, all of which are important to military operations,” she added
Haemonetics’ second automated offering is the ACP 215 automated cell processing system. The product allows a military unit to better manage a strategic frozen blood program, and then provide blood to troops very quickly in emergency situations and in remote parts of the world.
“In recent years, blood shortages have become a chronic problem,” recalled Fallon. Refrigerated red blood cells have a shelf life of just 42 days, so they must be transfused quickly or discarded. However, red blood cells can be frozen for up to 10 years, and then transfused.
“Haemonetics’ ACP 215 system processes red blood cells in a closed-circuit system for freezing and thawing, extending the shelf life of thawed red cells to 14 days. Red cells frozen and thawed in open systems only have a shelf life of one day,” said Fallon.
The concept of a frozen blood reserve is to freeze excess units of blood during times of surplus and save them for use during a time of need. “With Haemonetics’ systems, militaries are able to maintain frozen blood reserves in hospitals, in the field, and even on ships around the world. The blood can be quickly thawed and deployed for emergency situations when liquid blood reserves are not sufficient to meet demand,” said Fallon.
Through its 5D Information Management and its Information Data Management subsidiaries, Haemonetics also provides information technology support and re-engineering resources for the U.S. Department of Defense Blood Standard System
There are more than 400 Haemonetics’ devices in place worldwide to support U.S. military needs. Directly in theater, there are 10 MCS platelet collection systems in three different combat support hospitals and eight ACP 215 systems in two remote depots. These units are used to supplement the flow of blood products coming from the continental U.S.
Haemonetics’ products are in service in Europe with the Royal Dutch Navy, Italian Navy and German Bundeswehr.
OTHER DEVELOPMENTS
A recent entry to the U.S. market is the Biotest-manufactured Tango automated blood bank system. The device is reported to be an easy-to-use, random access benchtop analyzer which performs blood group serology including antigen typing and indirect antiglobulin testing.
There are two methodologies used on the Tango explained Joy Thomsen, manager, Transfusion Technical Services. “They include both hemagglutination using the Erytype S reagent system, and a unique microplate method for antiglobulin testing—the Solidscreen II reagent system,” she said. Thomsen also pointed out that the Erytype S strip technology is used for antigen typing, including forward and reverse ABO grouping and D antigen testing in various configurations. “The Biotest Solidscreen II methodology is used for indirect antiglobulin testing, which includes antibody detection using pooled, two and three reagent red blood cell sets,” she added.
In addition to the assays currently available on the Tango, reagents for Rh and Kell phenotyping, direct antiglobulin testing, antibody identification panel testing and crossmatch are actively under review by the FDA and should be available in the near future, as well as a full line of traditional manual Blood Bank reagents. The manual products include reagents for ABO/Rh, antibody screening and identification, crossmatching, direct antiglobulin testing, and rare antigen typing. Rare antisera includes products for Rh, Kell, Duffy, Kidd, MNSs, P1 and Lewis blood group systems.
The manual product line is under active review by the FDA and should be available in late 2007.
Tango’s Installation in military facilities is also expected later this year. “This will help ensure safe blood transfusions for military personnel by processing donor blood and performing pre-transfusion testing on patients requiring transfusion,” said Candace Williams, vice president, Transfusion Diagnostics.
The increasing demand for automated blood bank analyzers was most recently documented when a presolicitation notice was issued on behalf of the Transfusion Medicine Services Department at Tripler Army Medical Center.
INDUSTRY OPPORTUNITY
One opportunity to improve automated blood banking systems is to increase the number of tests that are performed on a single unit. One automated platform at the Armed Services Blood Bank Center can conduct ABO/Rh, weak D, antibody screen and CMV testing, and is adding a capability for syphilis. Other required tests such as HIV, HCV, HBsAg, HBcAb and HTLV are performed on a second testing platform, while nucleic acid testing is performed on yet a third platform.
“It would be nice if we could have one platform to conduct all of the testing that we are required to do—to put in one tube of blood and it did the whole testing requirement,” remarked Jenkins. ♦