Laboratory Medicine in Developing Countries:
Need for Immediate Improvement

Pathology is the keystone on which the edifice of scientific medicine is erected. It is especially important for cancer management. Although it is usually a surgical pathologist who comes to mind in the context of cancer, a wide variety of laboratory-based disciplines (e.g., histology, hematology, clinical chemistry, and microbiology) contribute to nearly all of the elements necessary to effectively control cancer. A lack of reliable and efficient pathology service can result in serious consequences for the patients as well as obscuring the true picture of the problem in an entire country.

Clinical laboratories have achieved significant improvements in the provision and quality of diagnostic tests. Automation, commercially produced reagents and computers are providing clinical oncologists with an ever-increasing list of rapid and cost-effective tests. Advances in pathology have occurred in concert with analytical developments that measure many different molecules with specificity for cancer or associated conditions, and with ever-increasing sensitivity. Such tests have revolutionized clinical diagnosis in ways that were unimaginable even a decade ago. As a consequence, pathologists and their departments, at least in most developed countries, are expected to meet stringent technical, management and quality-assurance standards.

It is unfortunate that the number and quality of clinical laboratories in developing countries leaves a lot to be desired. Although a few top-of-the-line laboratories in these countries compare favorably with those in developed nations, their number is very small. However the vast majority of cancer patients do not have routine access to such laboratories. The first medical encounter with the patient is likely to be in a small, poorly run establishment without access to the necessary diagnostic tests, where the significance of non-specific symptoms, such as fever, fatigue, pain or lymph node swelling - potential pointers to a diagnosis of leukemia or another form of cancer - may be assumed to be caused by an infection or other common disease, and the diagnosis of cancer missed.

In many developing countries, opening a laboratory is as easy as opening a grocery store - or rather, opening a grocery store may be more complicated! A pathology laboratory can be established without requiring permission from any government or professional association. There is no paperwork since there are no regulations governing the management or quality of laboratory practice and no license is needed. The factors determining the performance of a pathology laboratory include good equipment, reliable reagents and trained, conscientious staff, but many laboratories compromise on such vital prerequisites. In many cases, retired laboratory technicians and other, often entirely unqualified people, open small pathology laboratories, where standards are not maintained since their knowledge is limited. The managers earn money by using outdated machines, compromising on the reagents and by employing technicians in place of pathologists able to interpret the test results properly and to ensure the achievement of minimal technical standards. Yet the pathology laboratory should provide a vital part of the management of any cancer patient – any lapse or mistake in the performance of tests can lead to serious harm whether at the diagnostic stage or in the course of treatment.

Causes of Poor Pathology Services

There are numerous causes of poor services in pathology laboratories, the primary one being failure to follow regulations, or in some cases, to develop relevant regulations. The reasons for this are many and varied, but professional pathologists as a whole must share the responsibility for tolerating inefficient or flagrantly incorrect practices. The following factors are especially pertinent:

• Low Budget. In most developing countries, health care is primarily funded from general government revenue without charging the consumers. The expenditure on health is very low to begin with. It is, per capita, less than one quarter of what developed countries spend and often very much less. Moreover its distribution amongst the various sectors is inequitable. Most funding is spent on high-profile projects in teaching institutions in large urban centers. Laboratory services do not command a high priority.
• Scarcity of Laboratory Staff. The tremendous progress in the field of laboratory medicine has made accurate assessment and monitoring the progress of an ailment much easier. The result has been a great surge in demand for pathology services. It is unfortunate that the availability of laboratory personnel has lagged far behind. In addition, there is significant migration of trained manpower to more lucrative markets abroad. The exact number of pathologists working in Pakistan, their background and qualifications has not been determined. However, according to one estimate, there are no more than 1500 pathologists, or about 10 per million of the population. By contrast, a developed country, such as England, has 109 pathologists per million. Support staff, such as technicians, are in even shorter supply. In Afghanistan there are hardly any at all. In Brazil, until a few years ago, pathologists outnumbered technologists. There is no doubt that a huge gap exists between supply and demand.
• Poor Training. The training of pathologists and technicians leaves much to be desired. Most general pathologists have received as little as nine months training in four major subjects. Only in recent years has training been improved to acceptable standards. Similarly, many technicians receive only on-the-job training, with little formal education. The quality of the work of such a body of inadequately trained personnel is bound to be substandard.
• Lack of Appropriate Equipment and Infrastructure. Laboratory equipment is mostly manufactured in industrialized countries. It has become increasingly more sophisticated. The procurement officials in developing countries usually buy such fancy gadgetry for purposes of prestige rather than to make full use of its capabilities. There is no infrastructure for maintenance, or even an assured supply of electricity. It is therefore not surprising that developing countries are known as graveyards of equipment. It takes less than one year for some machines to break down in some way and approximately 60-80% of laboratory equipment is estimated to be non-functional.
• Lack of Regulatory Mechanisms. There is no license required to establish a clinical laboratory in many developing countries. In Southeast Asian regions of the World Health Organization (WHO), only two out of seven countries had accreditation programs. There are no rules or training requirements for non-pathologist physicians who run or lend their names to laboratories.
• Lack of Continuing Education. At present there is almost no provision for continuing education for pathologists. It is usually not required by the institutions who initially award them degrees. The result is that most do not keep up with advances in the field. Yet in such a fast-moving area, it is important that pathologists remain up-to-date with ever-changing terminology, as for example seen in lymphoid neoplasia and newer diagnostic tests. Use of non-standard terminology can lead to inappropriate therapy – it is essential that the nomenclature and classification used is widely understood not only within the country, but also abroad.

• External Quality Assessment (EQA). A system of EQA including laboratory licensure, accreditation, certification and proficiency testing has to be introduced to provide recognition to those who conform to acceptable standards. The current international requirements would perhaps be too stringent for the vast majority of existing labs. It may be necessary to evolve a system by which such laboratories are included in a simpler quality assurance program and are gradually brought up to international standards over a period of time.
• Training greater numbers of qualified Laboratory Staff. Quackery, in large part, is a reflection of the supply/demand gap. As the number of qualified pathologists is small, their place is taken up by quacks (unqualified non-medicals/untrained physicians). The supply of qualified pathologists can be increased by providing more training opportunities both within the developing countries themselves and, in some cases, abroad (although this is more expensive and entails the risk of economic migration). It may be helpful to arrange short visits by foreign experts. The non-qualified physician can be trained to undertake limited pathology work by providing them with the necessary training. There used to be a system of clinical side rooms attached to all wards where medical trainees carried out basic laboratory tests (e.g., urine and simple blood tests requiring, for example, dip-sticks). This needs to be reintroduced and strengthened.
• Telepathology. In view of the dearth of trained laboratory staff, telepathology could provide immediate relief by making expertise available electronically via the Internet or multiple telephone lines in far flung areas. This approach could also be used at an international level for both consultations and training, including continuing education (which, at least for qualified pathologists, considerably overlap).
• Suitable Technologies for Developing Countries. There is a plethora of in vitro diagnostic devices available in more developed countries. Equipment and reagents appropriate to the needs of developing countries should be introduced. A system similar to WHO’s essential drug list (essential laboratory tests) has been proposed. Pathologists should be trained in such techniques as fine needle aspiration and cytology. These procedures are quicker, less expensive and require less elaborate infra-structure and equipment such that they could be more rapidly and more widely introduced.
• The improvement in pathology services will be a slow process. It is however imperative that a beginning is made so that the suffering of patients is reduced and cancer control is brought onto a more rational and firmer footing.