The Challenges of Clinical Laboratories in Developing Countries

Achieving and maintaining quality is arguably one of the most critical tasks in clinical laboratories. Without a proper quality, clinical laboratories are essentially unsafe for patients. Poor quality results can cause mistrust between laboratories and end users, and therefore, endangers the practice of evidence-based medicine and precludes viable engagements between clinicians and laboratorians. Furthermore, poor quality clinical laboratories can hinder global efforts to fight infectious diseases and outbreaks (1).

Ensuring quality is a journey without a destination. It demands constant attention and continuous active participation of all involved in the testing processes. For example, the majority of testing transactions are mediated by clinicians. Their direct involvement in the testing processes makes them inevitable partners in ensuring quality. Thus, close cooperation and constructive engagement with clinicians is critical for laboratorians to provide sustainable quality service. However, ensuring quality can be laborious as it includes coordination with multiple bodies that are not conventional members of clinical laboratories.

The quality of most clinical laboratories in most developing countries is poor.  For example, most clinical laboratories in Africa do not meet international standards (2, 3). Why? There are several factors that contribute to this occurrence but the answer distills into the following: Lack of adequate resources, proper regulations, and supportive health care system.

Lack of adequate resources

The contributions of laboratorians in the diagnosis and management of diseases are generally under-recognized. Laboratorians in developing countries are no exception, if not worse. The lack of recognition compounded by inadequate compensation often leads to job dissatisfaction, negligence, lack of interest, and as a result, departure from the profession. The worst consequence of this phenomenon is over time depletion of qualified personnel, seeking for better opportunities elsewhere. While it is indisputable that developing countries face acute resource limitations, it is not necessarily due to lack of funding but also due to resource misappropriation, improper governance, and rampant corruption.

Lack of proper regulations

The notion that no result is better than poor quality result underscores the critical importance of quality in clinical laboratories. However, it is usually difficult to maintain quality without imposing proper regulatory requirements and enforcing strict regulations. For example, a survey conducted in clinical laboratories in Kampala, Uganda, reveals that most clinical laboratories do not meet international standards (1). Most clinical laboratories in Africa are not accredited (2). Most of the laboratories are not enrolled in external assurance programs; those enrolled do not necessarily adhere to strict follow-ups. These kinds of problems can be averted, at least in part, by introducing stringent regulatory requirements and enforcing the regulations to the details.

Lack of adequate support

Clinical laboratories in developing countries suffer inadvertent neglect and are not well-supported to ensure accurate diagnosis. The healthcare system in developing countries perceives clinical laboratories as “tools” rather than “partners” in the disease diagnosis processes. This kind of unfortunate perception is inherently flawed because clinical laboratories are indeed critical in diagnosing diseases, curbing outbreaks, addressing growing global health concerns. In that sense, laboratories and laboratorians should be deemed and treated as partners.  This is an important distinction to make because partnership fosters collaboration, respect, and recognition, encourages horizontal communications between laboratorians and clinicians, and helps garner support from clinicians, the public, and policymakers.

In summary, the majority of treatment decisions in developing countries are based on clinical judgment and empiric diagnosis (4). Because access to reliable diagnostic testing is limited or undervalued, misdiagnosis commonly occurs, resulting in inadequate treatment, increased mortality, and an inability to determine the true prevalence of diseases. Furthermore, mistrust is rampant due to poor quality results and consequently, viable engagements between the clinical laboratories and clinicians are often impaired.

Laboratorians in developing countries should set up efficient professional societies, enhance communication and diplomacy with clinicians and policymakers, and foster collaborative environment towards achieving continuous quality improvement. Strong and viable societies should then advocate for the wellbeing of clinical laboratories and laboratorians in developing countries. Furthermore, any effort from the global health community should first be directed to identifying and targeting fundamental problems in partnership with local professionals and authorities.

References

  1. Berkelman R, Cassell G, Specter S, Hamburg M, Klugman K. The “Achilles heel” Of global efforts to combat infectious diseases. Clin infect dis, Vol. 42. United States, 2006:1503-4.
  2. Schroeder LF, Amukele T. Medical laboratories in sub-saharan africa that meet international quality standards. Am J Clin Pathol 2014;141:791-5.
  3. Elbireer AM, Jackson JB, Sendagire H, Opio A, Bagenda D, Amukele TK. The good, the bad, and the unknown: Quality of clinical laboratories in kampala, uganda. PLoS One 2013;8:e64661.
  4. Petti CA, Polage CR, Quinn TC, Ronald AR, Sande MA. Laboratory medicine in africa: A barrier to effective health care. Clin Infect Dis 2006;42:377-82.

 

Tesfazghi_small

-Merih T Tesfazghi, PhD, is a Clinical Chemistry Fellow with the Department of Pathology and Immunology at Washington University School of Medicine in St. Louis, MO.

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