The Laboratory and Global Health

ASCP Global Outreach held an Advanced Hematology Training of Trainers workshop in Rwanda. The developing world has a need for training and education, realistic guidelines for what tests a lab should offer, and policy regarding lab quality assurance practices. The United States has a number of systems in place to ensure that clinical laboratory tests are accurate. Clinical labs must be licensed by the Clinical Laboratory Improvement Amendments, associated with accrediting agencies, and enrolled in proficiency testing. Laboratory personnel, from lab associates to lab directors must meet specific educational requirements and maintain competency. The US has 18,000 pathologists—around 5.7 per 100,000 people—plus clinical laboratory scientists such as clinical chemists and microbiologists,1 and more than 250,000 accredited clinical laboratories.2 In contrast, the developing world has a severe shortage of both quality laboratories and laboratory professionals. For example, all Sub-Saharan countries, except Botswana and South Africa, have fewer than 1 pathologist for every 500,000 people.3 Haiti, a country of more than 1 million, has only 7 pathologists. Diagnostic testing is offered by a network of unregistered laboratories, which operate without regulatory oversight. A survey of 954 labs in Kampala, Uganda, revealed 688 unregistered labs completely unknown to the Ministry of Health.4 Lack of professional direction and oversight might contribute to poor quality tests, misguided use of tests, and faulty interpretation of results. In fact, the World Health Organization (WHO) estimates 80 percent of suspected malaria cases are treated without confirmatory test results, in part due to lack of availability and physician mistrust of inadequate testing. Education, not just for the personnel performing lab tests but also for the physicians and healthcare workers using their results, and direction regarding laboratory quality assurance is needed to fill the gaps in laboratory medicine in the developing world. Also, those in these resource-limited settings need guidance in determining how to establish test menus, building the lab to best meet the needs of the community. WHO maintains the Model List of Essential Medicines (EML), first established in 1977 and updated every two years.5 The EML represents safe, effective medications to meet the most important needs of a given health system. A recent piece in The New England Journal of Medicine suggests the establishment of an Essential Diagnostics List to compliment the EML.6 The authors propose an initial list of 19 tests that would enable the effective, rational use of EML medicines. Further development of this list would require diagnostic specific criteria such as analytical performance and the potential to alter patient outcomes. Infrastructure and human resource needs should also be considered. For example, which tests need electricity or running water? Is there an alternative that does not have these requirements? Can the test be performed and interpreted by a layperson, or is specific education required? Lastly, policy is helpful to guide the establishment of laboratories and use of laboratory tests. While vaccines and medicines get a lot of attention—governments barring the use of expired medications, for example—there is little guidance in regards to laboratory diagnostics. Areas that could benefit from policies or official guidelines include quality assurance procedures of in-country labs, and labs or lab tests run by nongovernment organizations and medical missions. Not only are laboratories important to the health of developing countries, they are important to healthcare here at home, too. We don't think of our own backyard when we hear “global health” because we don't have many of the exotic diseases seen in other locales. This is in large part because we have quality lab systems in place. However, despite their significant role in health care, US labs face funding and staffing challenges, such as the medical technologist shortage. It is estimated that 7,000 medical technologist positions need to be filled annually, and only 6,000 medical technologists enter the workforce each year.7 The number of training programs has decreased by 15 percent since 1990. The Centers for Medicare and Medicaid Services have recently announced that a bachelor's degree in nursing is equivalent to the degree in biological sciences required to perform high-complexity testing. While nursing education provides invaluable medical knowledge, it does not include in-depth scientific study of the principles behind laboratory testing and technology. Both clinical and public health labs in the US are facing financial challenges. Public health labs especially have been functioning on minimal budgets for several years.8 With these challenges, maintaining the status quo can be difficult, let alone scaling up activities when needed to manage a global crisis. We are seeing this play out with the Zika virus. As of September 2016, the Centers for Disease Control and Prevention (CDC) had already spent 97 percent of allotted funding for Zika.9 State public health labs are worried about their ability to continue to meet routine needs while scaling up to perform Zika testing. The recommendation of the US Food and Drug Administration (FDA) for screening donated blood products puts an additional burden on laboratories and blood banks. The impact of lack of funding isn't only seen when new diseases emerge, and lab tests often aren't fully vetted by the FDA and require Emergency Use Approval, but also in situations with established laboratory diagnostics and appropriate treatment plans. Lead toxicity is a good example. Despite the availability of fast and affordable testing for lead exposure, the US is not doing a great job maintaining screening programs. In 2012, the CDC released new guidelines, which moved the threshold from10 mcg/dL to 5 mcg/dL. At the same time, federal funding for lead screening programs was cut from $29 million to $2 million. According to the CDC, the US is currently testing about 10 percent of our at-risk, younger than 6-year-old population.10 Only 11 states have federally supported lead screening programs. While Medicaid requires all enrolled children to be screened for lead exposure at 1 and 2 years of age, this requirement is not enforced. Based on Medicaid payment claims, in Ohio only 41 percent of children enrolled in the program and living in high-risk zip codes were screened for lead exposure.11 Other states, such as Missouri, have state-run programs. Still others have no recommended guidelines for lead screening. Many states do not report lead screening results to the CDC, meaning that lead exposure in the US might be severely underreported. Without labs, we can't detect disease and poison, such as AIDS or lead, before the damage is done. Without labs, we can't predict outbreaks and prepare preventive measures. Without labs, we can't effectively manage treatment and therapies such insulin and glycemic control. And yet, both at home and abroad—globally, if you will—labs are operating in spite of many challenges. However, there are many ways to help. First of all, we can work to promote the field of lab medicine, especially medical technology. Second, laboratory professionals, including medical technologists, can volunteer with nonprofit organizations to help train lab professionals in resource-poor settings. Third, we can engage in professional society activities, especially those that pertain to policy making and interactions with the government. It's our responsibility to strengthen and promote laboratories for a healthy global population.