|
|
| Italy
The Ospedale Maggiore in Milan has been around for more than 500 years. Initially founded in 1456 as a community hospital by Duke Francesco Sforza, it now serves as a university hospital. Within the Ospedale Maggiore Policlinico Mangiagalli Regina Elena, as it is formally known, lies its transfusion center, the Centro Trasfusionale e di Immunoematologia.
Founded in 1974, the center annually collects and processes nearly 29,000 whole blood donations for 10 hospitals in Milan. “Milan is a big city for Italy, but we manage to collect all blood donations at our center,” said Maurizio Marconi, MD, the lab’s director. Lombardy, the region where Milan is located, tops the charts with a population of more than 9 million. It has the highest population of any region in Italy, even the region of Lazio that includes Rome.
The center has 18,000 donors annually, with a turnover of only 10 percent per year. “The success is due to the fact that we provide all of our donors with various services, including medical counseling. We keep all their health records and provide them with a full medical evaluation conducted by a physician. If a problem arises, they [the donors] are treated by one of our physicians or referred to a specialist in our hospital,” Marconi said.
The center also provides various prevention programs to donors, such as the cardiovascular risk prevention program that monitors seven risk factors. All of these services are free to the donor. “The costs for the evaluation are within the reimbursement costs allowed by the region,” he said.
These benefits yield a high number of people who come back to donate again. “We mainly have repeat donors,” Marconi said. “This helps in reducing costs because we don’t have to be constantly looking for and screening new donors.”
Prior legislation mandated that each of Italy’s 20 regions had to develop and store rare blood units to supply that particular region. However, the only region that complied with the old law was Lombardy, where Marconi’s reference lab is located. The center has 18,000 regular donors, of which 1,000 are rare blood donors, and keeps a registry of more than 6,000 rare blood donors, which were identified by typing 48,000 donors from all blood banks in Lombardy between 2005 and 2008.
“We are now working on typing donors from all [over] Lombardy … to identify rare units,” Marconi said.
The regional government financed the collection of rare blood units in 2005 for a variety of reasons, one of which is accreditation. “The regional government selected our center among more than 30 blood banks because it was the only one fulfilling all requirements and the only one having been accredited by AABB as an IRL,” he added.
The center’s immunohematology reference lab became AABB-accredited in 2003 partially due to the efforts of the late Fernanda Morelati, DSc, the lab’s previous head. “This was a big challenge for us because the reference for us has always been the model of the Technical Manual, the AABB standards, but in Italy there wasn’t a reference authority that could help us at the time,” Marconi said.
“We were certified by ISO 9000, but these procedures were more general,” he added. This [AABB accreditation] led us to revise our way of working. So accreditation had a strong and positive impact on the way we now work.”
Before 2003, there were no rare blood donor banks in Italy, so, once accredited, they reached out for support in the U.S. and the U.K. to establish a rare donor bank. “We now have a register of rare donors that can be called when a particular phenotype is needed. In all, we have 7,084 rare donors, 6,745 of which are rare for a combination of common antigens, 314 for high-frequency antigens, and 25 with rare Rh phenotypes,” he added.
Marconi says that AABB accreditation has been worthwhile. “We feel assured of the quality of our services because of AABB accreditation. This is important for us and for the services we provide to our donors and patients.”
Colombia
Colombia lies on the top of South America, bounded by the Caribbean Sea. Almost 70 percent of its population of nearly 45 million lives in urban areas, such as the city of Cali — the third-largest in Colombia.
Cali is the home of the Cruz Roja Colombiana Seccional Valle del Cauca, or Red Cross Blood Center. The center offers a variety of important services to the community, including medical evaluations, X-rays, vaccinations, dentistry and other services at cost. It also offers a wide range of blood donation programs in schools and public health educational campaigns through health fairs.
In 2008, the center collected 32,000 whole blood units from 40,000 donors. “We have three air-conditioned bloodmobiles, and they collect about 80 percent of the blood donations,” said Miguel Escobar MD, FACP, the center’s medical director, who was trained as a hematologist in the U.S. “I had learned about the importance of blood quality and safety, so when I began working in a Colombian blood center I suggested that we become accredited because it could help us provide safer blood.”
“We became AABB-accredited in 2004,” said Escobar, whose lab also became ISO 9000-accredited in 2006. “We were the first in the country to obtain AABB accreditation. Of the seven Red Cross banks in Colombia, we are the one with the most donors and the only one that is AABB-accredited.”
“Frankly, I thought it was going to be difficult to implement the changes that come with accreditation as people are generally resistant to change. But we found that when we explained the responsibility our center has in providing safe blood to the community, the staff got on board and the changes went smoothly,” he said, adding that the center hired a translator to communicate with the AABB assessors.
“I’ve been ‘unofficially’ supporting other banks in Colombia that are considering accreditation. I pass on the AABB accreditation information and help them by answering any questions so they can start thinking about accreditation.”
“After we became AABB-accredited, we received some requests from other banks, both from Colombia and abroad, that wanted to visit us to learn more about the accreditation process. We became sort of a reference point for other banks. This is important because other banks are looking for the same thing we were, which is quality and safe blood,” he added.
“We’re proud to be AABB-accredited,” Escobar said. “Most professionals in Colombia’s blood community recognize the importance of being accredited.”
In Colombia, an institution within the ministry of health certifies and supplies the minimum mandatory requirements for a blood bank. Two or three times a year surprise visits are made to the blood banks to ensure compliance. Colombian blood banks also may carry out voluntary external quality assurance with internationally acknowledged institutions, such as AABB.
Brazil
The Hospital Israelita Albert Einstein is located in Sao Paulo, which is the largest city in Brazil and also one of the largest in the world, with a population of nearly 19 million in its metropolitan area.
The hospital has 460 beds, employs 6,700 individuals and performs 26,000 surgeries every year. It also has spent $20 million to develop a public cord blood bank.
Albert Einstein is one of the leading hospitals in South America. “Besides providing excellent quality of care, we try to acquire the best equipment and technologies. We were the first in the country to offer NAT testing even though it is not a required test,” said Jose Kutner, MD, PhD, the hospital’s medical director for the blood bank. “We also were one of the first institutions to obtain apheresis machines in the 1980s.”
The blood bank, which lies within the hospital, collects about 12,000 whole blood donations a year. The lab itself became AABB-accredited in 1998.
“Prior to AABB accreditation, we had ISO 9000 certification, which was very useful but it wasn’t technically focused toward the blood banking field,” Kutner said. “We thought we needed a pathway to improve our performance and the services offered to our customers and believed AABB accreditation would help us reach that goal.”
Kutner admitted that accreditation is a long process, but he said it is an investment to become a better blood center. “Besides, AABB provided us with a lot of support through their accreditation process and other materials such as publications,” he added. “The assessors were important because they provide us with an external view — sometimes the problem is right in front of you, but you just can’t see it because you’re so involved.”
The center’s procedures improved after AABB accreditation, Kutner said. “We did not know then how important some things were, such as keeping track of all needed information throughout the process. We really had to change our thinking about the process,” he said.
“Ten years ago, when we first were undergoing accreditation, it was hard to make the staff understand why it was important to write so many things down and to be careful about following procedures. But now everyone understands the procedures and the importance of quality and safety.”
Quality has been at the heart of the hospital’s policies. In 2000 the hospital became accredited through what is now known as The Joint Commission, and in 2008 the immunohematology reference lab became AABB-accredited. The lab also undergoes routine governmental inspections.
“We were the first center to be AABB-accredited in Brazil, although today more centers are AABB-accredited,” Kutner said. “Having the AABB accreditation sets the standards for the work one does. Besides, through the services offered, you feel like you have the whole AABB staff behind you.”
Israel
The Sheba Medical Center at Tel Hashomer is the largest medical center in Israel.
Located in the outskirts of Tel Aviv, it has 1,700 beds, employs 6,000 health care professionals and handles more than 1 million patient visits a year. The center is a powerhouse of innovation, conducting 25 percent of all Israeli medical clinical research.
Sheba Medical Center was born along with Israel in 1948 when it was first set up as a military hospital. Today it remains the main hospital for the Israel Defense Forces but also is home to research centers in autoimmune diseases, cancer, genetics, cardiology, diabetes, neurosciences, stem cells and regenerative medicine.
The cord blood bank at Sheba Medical Center is one of only two in Israel. It was established in 2001 and currently holds approximately 2,000 frozen units. To date, 31 cord blood transplants have been performed at the center.
The cord blood bank — which also holds the National Marrow Donor Program and NetCord accreditation — became accredited by AABB in 2006. “I was a postdoc at Stanford University and wanted the bank to be the first in Israel to have AABB accreditation,” said Arnon Nagler, MD, who founded the bank and still heads it. “We wanted the gold standard, so we decided to become AABB-accredited.”
“It’s very important to have high-quality cord blood, and it is well-known that accreditation can help improve and maintain quality,” Nagler said. “But we had to vary things slightly to make them applicable to Israel.”
A disaster plan, for instance, is needed as part of the accreditation. “In the U.S., one could have a disaster plan for hurricanes. In Israel we don’t have hurricanes, but there is the possibility of armed conflict at any time, so we prepared a disaster plan accordingly. AABB was very accommodating and helped us through the process,” he added.
Israelis, Nagler said, have a bit different genetic makeup than Americans, which can affect cord blood transplants. However, both countries do have a Jewish and Arab population.
He added that genetic diseases, such as Gaucher disease and beta thalassemia, are more prevalent in Israel because some Arab minorities and very religious Jewish groups do not marry outside their own communities.
Nagler believes that accreditation also can help set worldwide standards for cord blood. “We envision that perhaps one day the FDA may not allow bone marrow centers in the U.S. to obtain cord blood from banks that are not accredited. It’s important for us to continue to be part of the worldwide network of cord blood banks.”
As for advice for those considering accreditation, Nagler said: “The accreditation process is not easy, but it is also not impossible. It’s more a question of spending the time and work needed to be certified. It’s definitely worth it.”
|
| |
| |
|