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Lab Matters cover 
Realizing the APHL Vision Around the Globe

In 2005, when APHL first began working in Mozambique, physicians and patients had little access to the laboratory tests that are vital to regulate the treatment of HIV/AIDS with potent antiretroviral drugs. Even in the capital city of Maputo, hospitals relied on a single laboratory at the national health institute for CD4 cell counts—with a lag time of 30 to 90 days for test results.

Realizing the APHL Vision Around the Globe

“A healthier world through quality laboratory practice.”
APHL Vision Statement

      It was a dismal situation in a country where nearly 20% of the population is HIV positive.
      Recalling his first visit to the provincial hospital in Maputo, Ralph Timperi, MPH, said, “They only had a biochemistry analyzer and only occasionally the reagents for testing. So there was not the capacity to do the diagnostic tests to support HIV treatment.”
      As APHL’s global health program director and senior advisor for laboratory practice, Timperi has been on-site frequently in Mozambique to oversee a large-scale project in which APHL has assumed responsibility for procuring testing instruments and reagents throughout the country and assuring training for laboratory technicians
and support for equipment operation.
      Today, Maputo’s provincial hospital has been renovated,
fully equipped with appropriate instrumentation and supplies and staffed with trained technicians. HIV diagnostic and treatment-related test results are often reported out within 24 hours and routinely within two days.
      With similar upgrades in 35 other laboratories throughout the nation—and simultaneous improvements in clinical care—Mozambique has seen a spike in the number of residents receiving antiretroviral treatment: from about 10,000 people three years ago to 95,000 today. Although this is still a fraction of the estimated 1.8 million Mozambicans living with HIV, it is progress that was unimaginable six or seven years ago. And it is just the beginning.
      “We’re very committed to the work in Mozambique,” said Timperi. “Our hope is to be able to work here for as long as our assistance is needed, and to assist Mozambique officials as they build their laboratory infrastructure so that we are no longer needed.”
      The Mozambique program exemplifies APHL’s growing
commitment to international laboratory improvement: providing a range of support, from technical assistance in resource-constrained countries to influenza preparedness and foodborne disease surveillance.
      Executive Director Scott Becker explained therationale behind APHL’s determinedly multinational approach. He said, “First, it’s the right thing to do. And second, disease knows no borders. How can we address US public health threats without taking a global perspective?
Having strong laboratory systems elsewhere helps here.”


Evolving APHL’s Global Health Work

      Measured in terms of funding, the bulk of the association’s
international work is laboratory infrastructure development in resource-constrained countries. APHL has been engaged in this task for more than a decade, has its own global health program and is a well-known resource for the CDC, the World Health Organization (WHO), the Pan American Health Organization (PAHO) and other international assistance agencies.
      The current sophisticated, multi-million dollar operation grew surprisingly quickly from assorted early efforts that were ad hoc and member-driven. Long-time member Eric Blank, DrPH, head of Missouri’s state public health laboratory, said the initial impetus for the association’s work with foreign governments was the human immunodeficiency virus. APHL, said Blank, “had taken a leadership role in the consensus conference that led to the testing protocol for HIV.” This expertise was of enormous interest to the developing countries hit hardest by the epidemic.
      In 1985 Mahadeo (Dave) Verma, PhD, who then directed Delaware’s public health laboratory, turned down a CDC offer to spend two years in India working on a biomedical research
project. Instead Verma, who is of Indian origin, hosted several high-level Indian laboratory officials at his facility, in a project coordinated
with the CDC and funded through the US Agency for International Development.
      “Following that, since we had gotten several government officials
here, it became an easier path to move into work in India,” said Verma. “We started to exchange folks and to take people from here there to see what problems there were... Well that was just the beginning of the whole thing.”
      The turning point came in 1990 at APHL’s first strategic
planning meeting, convened by then APHL president
Verma. Blank said, “As we did this, it became clear that our organization really does believe in improving global health and improving laboratory quality across the world.”
      That sentiment is now embedded in the APHL mission
statement, which calls on the organization “to promote the role of public health laboratories in support of national and global health objectives.”
      In the early 1990s, APHL received grants from the World AIDS Foundation, the World Bank, US Department of the Interior, National Institutes of Health and other funders to expand its global work. One project was a series of HIV rapid testing training workshops delivered in four Indian cities. Another project focused on laboratory-based tuberculosis diagnosis in the Pacific islands. But, said Blank, these were still “individual projects that were the result of individual actions as opposed to an organized, concerted approach by the association.”
      Although APHL’s leadership recognized a need to “put a structure” to its global health work, Blank said, “the problem was we really needed to find a consistent funding source to continue those activities under the auspices of the association.”


Disisaster Strikes with Mitch and Georges

      Then in 1998 hurricanes Mitch and Georges hit Central America and parts of the Caribbean causing catastrophic flooding and killing thousands. Both the CDC and PAHO approached APHL to solicit assistance with the reconstruction of the seven most severely damaged nations.
      “That was a long-term project,” said Blank, “in which we would be committing ourselves to help those countries restore their public health infrastructure. It was a contract, not a cooperative agreement. It was a large dollar figure and it required an extensive commitment
from several of our members and from the association to see that through.”
      One member who took part in that work is Sally Liska, DrPH, who now directs the San Francisco public health laboratory. Liska spent several weeks in Haiti. Because Haiti had no public health laboratory system even before the storms struck, she worked with the director of the national hospital laboratory and policy makers in the Haitian Ministry of Health.
      Two aspects of Project Mitch and Georges are notable. First, because it was a reconstruction project, funding could be used to meet an array of needs. “So often we have categorical funding that can only be used for one purpose,” said Liska. “But we could purchase equipment for labs, do minor renovations, do training.”
      In fact, APHL helped to procure millions of dollars in laboratory equipment, refurbished plumbing and electrical
systems and offered training in testing methods for everything from tuberculosis to dengue to measles.
      “I would bet you that there are still freezers, incubators,
microscopes that are still in use in those countries that were purchased by APHL,” said Liska. “So that’s part of the legacy.”
      But the reconstruction effort went further yet. The second notable achievement was to instill the concept of public health laboratory practice in countries like Haiti, which had had only a “quasi-PHL.” This entailed a philosophical change, said Liska.
      “They didn’t just get equipment; they got knowledge about what a PHL and PHL association are all about. They were able to see the benefit of the kinds of services they could offer, such as disease surveillance and working more closely with epidemiologists.”
      Laboratory directors from the seven countries received training in laboratory management, human resource management, conflict resolution and quality assurance. They also came together on several occasions throughout the reconstruction period to network and problem-solve. When the project ended in 2002, the laboratory leaders in the sub-region declared their intent to establish their own public health laboratory association.
      When APHL went into Project Mitch and Georges it was “a relative newcomer” to the international stage. But, Liska said, “we proved ourselves. We now are a big player.”
      Today, the APHL global health program operates with a budget of more than $11 million and seven full-time staff members who regularly traverse the globe to coordinate projects on four continents. It employs four technical consultants based in the US and abroad and has enlisted the services of nearly 50 APHL members, whose special expertise has been of direct assistance in international projects.
      In recent years the program has delivered laboratory
management training in five countries, piloted an external quality assurance program in Ethiopia, supplied Rwanda’s national laboratory with the equipment to perform pediatric HIV diagnosis and evaluated a number of Chinese public health laboratories to help that country transition its research-oriented infectious disease institutes to a public health laboratory-based disease surveillance network. And much more.
      Yet while APHL has taken on many different support functions, Blank explained that the association’s strength is “developing quality laboratory systems, developing laboratory networks in countries
and within regions, providing leadership and management training.”

 

Providiiding Leadership and Management Training In Country

      Said Blank, “One of the things anybody who has gone overseas very quickly realizes is that unless you have good systems and good management in place, you can teach people how to do a test and when you go back six months later, it’s like you’ve never been there.”
      A particular APHL forte is strategic planning to align public health laboratory systems with national health priorities. In Kenya, APHL contributed to the development of the country’s National Policy Guidelines for Medical Laboratory Services, which details the steps to define minimum standards for laboratory practice, identify a base set of laboratory services for each level of health care, implement standard operating procedures and design monitoring systems to assure continual quality improvement.
      The head of Kenya’s National Public Health Laboratory
Services, Jack Nyamongo, noted that the newly developed plan is of “critical” importance as it identifies service and resource gaps and provides a roadmap for the “mobilization and equitable distribution of resources” in step with national priorities. Thus, donor funding is more likely to go where it can do the most good, and more donors will be inclined to contribute.
      The association is involved in similar strategic planning
efforts in other resource-constrained countries, including Tanzania, Cote d'Ivoire and Vietnam.
      Mozambique—a major focus of the global health program—has participated in a range of laboratory improvement activities over the past three years, including everything from high-level strategic planning to a detailed tracking of laboratories’ downtime due to instrument failure.
      Speaking recently from a cell phone in Maputo, Timperi
discussed the latest effort to ramp up the country’s public health laboratory infrastructure, an intensive educational program to prepare biologists to practice medical laboratory science.
      Timperi was on-site with colleagues from the CDC and the Mozambique Ministry of Health to review a training curriculum that will be delivered at the University of Miami in Florida and APHL member laboratories and to begin long-term planning for transferring the training capacity to Mozambique. As part of this effort, he evaluated several sites for their suitability asin-country training centers after upgrades supported by APHL.
      The effort, said Timperi, is a “bold initiative” involving
a number of partners, including the Mozambique ministries of health and education, CDC in Mozambique and the University of Miami School of Medicine. It aims to provide capacity for in-service training for the critical workforce of laboratorians who have had limited opportunity for formal education.
      Eventually, Timperi said, the program “should provide
to Mozambique enormous capacity to improve the quality of work in all of their laboratories.”

Partnering to Create New Resources

      Two other long-term global health program projects stand out. In 2007 APHL and the George Washington University (GWU) School of Public Health and Health Services jointly developed the GWU-APHL International Institute for Public Health Laboratory Management, an international resource to develop the senior laboratory management expertise lacking in many developing nations.
      And, with funding from the WHO Twinning Initiative, APHL has matched the national laboratories in Mozambique, Ethiopia and Barbados with partner laboratories in the United States. [Mozambique is paired with the Michigan and Los Angeles public health laboratories; Ethiopia with the California state public health laboratory and local facilities serving Contra Costa County, San Diego and San Francisco; Barbados with the Utah public health laboratory.]
      These partnerships facilitate a ready exchange of ideas regarding technology, training and quality practices
that can improve national public health laboratory
systems and help meet the demands of infectious diseases surveillance and response.
      For several years the global health program received
the majority of its financial support from the CDC Global AIDS Program. In 2003, that funding was eclipsed by the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion effort to support national responses to the HIV epidemic in the highest prevalence nations worldwide.
      But even in its HIV/AIDS-related work, the program has taken a broad perspective. Blank said, “If you’re building good quality systems and good quality laboratory
practices, you’re basically building a structure to improve laboratory services across the board.”
      He noted that in addition to HIV/AIDS, many developing
countries are struggling with diarrheal diseases,vaccine-preventable disease for children, tuberculosis, malaria and other serious health threats. “We are optimistic,” said Blank, “that funding will increase and include activities in many of these other critical areas that are causing high morbidity and mortality in developing countries. APHL is recognized as one of the leaders in building international laboratory capacity (hands-on, international laboratory development) and increasingly draws on the experience of its public health laboratory members.”
      With the original PEPFAR authorization expiring this year, the Senate Committee on Foreign Relations has approved the program’s reauthorization at a level of $50 billion for the next five years, beginning October 1. If the relevant bill (S.2731) is signed into law, the progress in the fight against HIV/AIDS will continue.
      The association also expects to continue its partnership
with the CDC. Bob Martin, DrPH, laboratory science officer in the CDC Coordinating Office for Global Health, said, “There’s no doubt that APHL will continue to be an important part of whatever CDC does. There’s just too much work for one or two organizations to do on their own.”
     Martin noted that APHL offers unique assets in the international arena.
      “APHL brings subject matter expertise from within the PHLs. The other thing APHL brings, of course, that no one else has, is a sense of public health service delivery, and that shouldn’t be minimized. Universities don’t bring that to the table. CDC is a national organization
and doesn’t bring that service experience to the table in the same way. In most countries that we work in, laboratories resemble state PHLs more than they resemble national laboratories in the US.”
      Looking forward, APHL’s Becker said the association is committed to sharing its expertise not only through the global health program, but wherever it makes sense to do so. “It’s part of our organizational DNA to do this,” he said.
      In fact, international activities are underway in several APHL programs.
      Informatics: Working closely with the global health program, APHL’s public health informatics program has been helping to implement laboratory information systems (LIS) in four countries: Mozambique, Tanzania, Ethiopia and Vietnam.
      Patina Zarcone, MPH, who directs APHL’s informatics
and knowledge management activities, noted that “a disease can travel around the world in three or four days.” She said, “If that’s the case, without a way to share information, none of us will be prepared.”
      APHL informatics activities begin from the ground up; first helping laboratories streamline their workflow to assure efficient data collection. Some countries, said Zarcone, “may not be ready to dive into electronic information management,” in which case APHL helps to optimize paper-based systems. Once a laboratory is primed to transition to electronic media, the association uses a standard process to identify an appropriate LIS solution and assists with everything from system acquisition to computer skills training.
      Perhaps the most interesting project is unfolding in Vietnam, which is piloting an open source LIS—Open ELIS—developed by three US state public health laboratories. Vietnamese-based software development contractors spent two weeks at the Minnesota laboratory to familiarize themselves with the system, which this past February was deployed at the District Four Health Center in Ho Chi Minh City and the National Institute of Infectious and Tropical Diseases in Hanoi.
      Zarcone said, “We have a rare opportunity to learn from the mistakes we’ve made with laboratory information
systems domestically and to implement them right the first time in these other countries.”
      Influenza: Closer to home, APHL is working with its Canadian sister organization—the Canadian Public Health Laboratory Network—to organize the first cross-border influenza summit, which will take place in Toronto this September.
       As of mid-March, 372 cases of avian influenza had been detected worldwide, as well as cases in the poultry populations in Europe, Asia and the Middle East. Although no US cases have been reported to date, the North American SARS outbreak—centered in Toronto—alerted US health officials to a slew of problematic questions that would arise from cross-border avian influenza transmission.
       “Let’s say someone crosses the border from Canada and ends up in a US hospital and is determined to be the sentinel case for avian flu,” said Rosemary Humes, MS, MT(ASCP) SM, APHL’s senior advisor for scientific affairs. “What are the legal issues around disease reporting? Could we provide surge capacity testing or could Canada provide surge capacity testing? Are we even using the same testing methods (to assure comparability of test results)?”
       Discussing these issues will be experts from 11 Canadian
provincial laboratories; 14 US border state public health laboratories; the Erie County, Detroit and Seattle public health laboratories; the World Health Organization; the CDC; Canada’s National Microbiology Laboratory; and US and Canadian clinical labs.
      For the past three years, the association has also been working with the CDC to deliver influenza laboratory
detection courses in Southeast Asia, India, South America and Africa. Humes said, “We want to assure rapid molecular detection capability, especially in high-risk areas like Southeast Asia where avian influenza has become established.” Advance collaboration, she said, “makes it easier for everyone later on.”
      Food Safety: The internationalization of the food supply has changed the nature of foodborne disease outbreaks. In addition to the classic, localized “church supper” outbreak, which is relatively easy to detect, the world is experiencing different kinds of outbreaks, with few cases spread over vast geographic areas.
      Foodborne outbreaks in developing countries are frequent, involve large numbers of cases and are often focal, single source. The global food supply that brings food from resource limited countries around the world to developed countries brings a risk of contaminated food. Resource rich countries can afford to import—and consumers can afford to pay—for “seasonal” products year-round. The technology has increased sensitivity of surveillance and can detect widely dispersed as well as small numbers of cases.
      This shift has compelled laboratory scientists and epidemiologists worldwide to work together to detect and investigate cases of foodborne disease. One tool that has revolutionized the process is PulseNet, a network of public health and food safety laboratories established by APHL and the CDC in the mid 1990s and expanding ever since.
      What began as PulseNet USA has morphed into PulseNet International, with regional networks in the US, Canada, Latin America, Europe, the Middle East and the Asia Pacific region.
      Participating laboratories perform a standard molecular
subtyping technique—pulsed field gel electrophoresis— that can distinguish strains of foodborne, disease-causing bacteria at the DNA level. Bacterial DNA “fingerprints” are then exchanged in real-time, enabling scientists to link patients throughout the world to the same outbreak.
      Just last year, PulseNet was responsible for detecting:
• 30 cases of Salmonella Senftenberg Infection in England and Wales associated with fresh basil imported from Israel.
• 218 cases of Shigella sonnei infection in Denmark and 12 in Australia linked to imported baby corn from Thailand.
• 40 cases of Escherichia coli O157:H7 infection in a multi-state US outbreak linked to beef trim imported from Canada. The FDA recalled more than 20 million pounds of meat as a result of the investigation.
      APHL has supported the network from its inception. Most recently, the association co-sponsored the second meeting of PulseNet Middle East in Cairo, Egypt, last December and the fifth meeting of PulseNet Asia Pacific in Kolkata, India, this past February. It is helping to organize the annual meeting of the PulseNet International steering committee, on which it serves, in Halifax, Nova Scotia this summer.
      APHL also collaborates with partners to offer technical training for PulseNet scientists and provides direct grants to international member laboratories to purchase laboratory equipment, send staff to training programs and develop websites.
      Brent Gilpin, a senior scientist with New Zealand’s Institute of Environmental Science & Research, said the association has been an “integral and most supportive
partner” of PulseNet Asia Pacific “right from the very first meeting in 2002.” Said Gilpin, “In a politically and culturally divided region, APHL’s independent and unifying presence has been crucial to the development of PulseNet.”
      Due to its contacts in Africa and at the WHO, APHL has linked the CDC to officials interested in developing a PulseNet Africa.
      “We live in a globally connected microbial soup, with food distributed worldwide, and the potential for emerging pathogens to be transported to every part of the world within days,” said Gilpin. “Global networks such as PulseNet International will be an essential component of an integrated public health response.”
      Newborn Screening: Since screening for heritable and genetic conditions is a much lower priority in resource-constrained nations than the control of infectious diseases, the association’s international newborn screening work has been evolving slowly.
      About three years ago, APHL joined the International
Society for Neonatal Screening (ISNS), and invited its president, Gerard Loeber, to serve as a liaison to the APHL Newborn Screening & Genetics in Public Health Committee. Last year APHL and ISNS made the first moves toward the formation of a North American chapter of ISNS. Loeber is also part of the planning committee for the association’s upcoming newborn screening and genetic testing symposium.
      The most exciting development in international newborn screening, however, came in late 2006—a groundbreaking conference in Marrakech, Morocco. The gathering, primarily sponsored by the National Institute of Child Health and Human Development and the Moroccan Ministry of Health, marked the first major effort to strengthen national newborn screening programs in the Middle East and North Africa.
      APHL—which co-sponsors the CDC Newborn Screening Quality Assurance Program (NSQAP)—was represented at the meeting and also took part in a follow-up conference in Cairo, Egypt, this past April. NSQAP itself is a comprehensive provider of quality assurance services for newborn screening programs worldwide, delivering quality control materials, proficiency testing services and technical support to 61 US laboratories, 28 manufacturers of diagnostic products and 470 laboratories in 71 countries.
      Loeber, who is based in the Netherlands, wrote via e-mail that APHL “has a lot to offer in terms of experiences in organization of meetings, etc., but also in the formation of policies.”
      He noted that “so far, there is no official joint effort between APHL and ISNS (to support newborn screening in resource-limited countries), but unofficially we have contacts in this matter. These activities are important because at present only about 25% of the infants born world-wide are screened.”
      As reflected in its vision statement, it is APHL’s goal to strengthen public health laboratory practice to achieve not just a healthier nation, but “a healthier world.”
      Said Timperi, “With a small effort on our part, we can lift up the quality of testing significantly. When you’ve spent a long career in public health and accumulated expertise, you want to spend that capital. It makes our members realize the importance of their careers.”
      Or, as Becker said, “How can we not contribute to this work? It’s what we do.”