Quality Assurance for African Laboratories: How Soon can this be Accomplished?

Abstract

Dear Editor, This paper is intended to raise concern on how feasible institutional laboratories in Africa would be able to achieve efficient quality control (QC) with the full justification of credible and authentic results that can stand the test of time anywhere globally. This goal appears to be a very difficult task due fundamentally to myriads of inherent challenges to be curtailed with. Basically, most results emanating from most African institutional laboratories lack consistency, accuracy with the fact that sensitivity and specificity are highly compromised. Laboratory physicians and scientists give so many excuses for such regular deficiencies. On so many occasions reagents are not available even if they are accessible some are not properly stored and preserved. Again majority of such reagents may have expired and in a bid to replace them, the consistency may have been interfered with, thus prolonging the turn-around-time (TAT). Such prolonged laboratory reports would have lost its value before the attending clinician who may have treated his patient empirically. On the other hand reagents that are not properly stored or that have expired or nearly expired would produce many highly compromised false positive and false negative results. Studies have shown that most reports turned out by European or American institutional laboratories are timely and credible.[1] The reasons for this is due to the fact that quality assurance (QA) is a routine practice as most of the recommendations of Association of Directors of Anatomic and Surgical Pathology (ADASP) have been strictly followed. These includes pathology departmental document on QC and QA (QC/QA) including all the indicators and establishment of QC/QA monitoring committee. Practically speaking, the driving force of reliable QC/QA involves the application of standard operational procedures (SOPs) for all laboratory methodological procedures viz-a-viz proper calibration of equipments and machines, adequacy and proper storage of reagents, handling of specimens with stepwise preanalytic, analytic, and postanalytical procedures are optimally adhered to in developed countries laboratories. However, this assertion cannot be made for laboratories operating in most developing counties as the recommendations by ADASPs have not been fully carried out due to so many local inherent problems. The use of electronic gadgets including the intranet and internet facilities had all contributed immensely to the credibility and authenticity of these results. For example in most developed countries institutional laboratories, results of blood and other body fluid tests ordered for are usually been displayed on the electronic medical records through the intranet few minutes to hours as the patients is been examine by the attending physicians.[1 2] Yet again, 48 h after a patient undergoes breast lumpectomy, a pathologist report showing invasive ductal carcinoma of no special type (NST) including the Nottingham grading and the estrogen receptor (ER), progesterone receptor (PR), and Her-2-neu with all red score report would have been available to the surgeon for definitive treatment and prognostication. Reports by Amukele et al.,[2] have shown that if African institutional laboratories have the full resources and opportunities, results that would emanate from these laboratories would be timely, effective, precise, and specific. According to Amukele et al.,[2] the United States President's Emergency Plan for AIDS Relief (PEPFAR) multicentric laboratories located in many African countries have stood the test of times by all standards in the area of research. PEPFAR laboratories in Africa have been able to demonstrate consistency, precision, and reliability in the results that emanate from its laboratory. The reason for this is that SOPs are strictly maintained with strict adherence to external and internal QCs. All PEPFAR centers are fully equipped with electronic media for rapid results issuance, adequate archiving, and efficient bilateral communication with the sponsors. Again, the laboratories machines and equipments have been fully automated to reduce results bias in most analytic procedures as against manual and semiautomations seen in most other local laboratories. Over the years these systematic approach to accuracy in preanalytic, analytic, and postanalytic procedures have justify the high confidence placed on the PEPFAR results. Nonetheless one major challenge is how to flawlessly integrate this confidence and reliability in PEPFAR research works into routine laboratory works and how to expand and extend collaboration of PEPFAR to cover more grounds in other African institutional laboratories. The role of PEPFAR was further supported by the medical education partnership initiative (MEPI). The MEPI main goal is to work in partnership with African countries to improve the quality and quantity of medical and healthcare-related professionals.[1 3] With the view that more laboratory physicians and scientists will be trained and retrained to be able to tackle imminent challenges and set-backs facing African laboratories. In addition MEPI mandate to upturn the challenges of prolong TAT, instruments/equipments maintenance and calibration, and constant supply of reagents has not been fully justified.[2 3] Based on these, hospital administrators must make resources always available because the importance of the laboratories cannot be overemphasized to the management of patients. The African Society of Laboratory Medicine (ASLM) was inaugurated in 2011 in Addis-Ababa, Ethiopia with the mandate of advancing laboratory medical practice in African countries including continuing medical laboratory education. Again, it is aimed at collaborating with other international organization like the WHO in ensuring that quality standards are maintained in African laboratories.[4] Futhermore the ASLM vision 2020 include: Developing strong, harmonized regulatory systems for diagnostic products as defined by the Global Harmonization Taskforce Transforming laboratory testing quality by enrolling laboratories in quality improvement programs to achieve accreditation by international standards Strengthening laboratory workforce by training and certifying laboratory professionals and clinicians through standardized frameworks Building a network of national public health reference laboratories to improve early disease detection and collaborative research.[4 5] ASLM currently have aimed to maintain movement toward accreditation and improved laboratory systems have gained significant momentum in the past few years. Again this organ is currently addressing the challenges of working in collaboratively with governments, local and international organizations, implementing partners, and the private sector to achieve the following goals by 2020. Nevertheless, these challenges have not been fully tackled by ASLM because of poor funding, lack of man power and political will by some governmental bodies. It is recommended that ASLM should be able to achieve its goal of advancing the standards and quality of laboratories in African continents. This can be done through stepwise guiding approach recommended by the WHO known as the Stepwise Laboratory Improvement Process Towards Accreditation (WHO AFRO SLIPTA).[1 3 4 5] Now, other supportive organizations like the International Academy of Pathologist (IAP) and the friends of Africa initiative are all striving hard to improve the quality of laboratories and to advance professional laboratory best practices in Africa. However, this recently has shown some commitments in fostering a constant relationship between Africa and America and the rest of the world. Still, the challenges are numerous as a great deal is yet to be achieved by these collaborators as healthcare and standard best practices in our laboratories still remain a luxury. We indeed look forward for more proper coordination and collaboration of IAP in the nearest future. So many other challenges plaguing the health sector have contributed to the near stagnancy witnessed in most African laboratories. In spite of already tailored job description in the pathology departments, there is still workplace crisis between laboratory scientists and pathologists particularly over the headship of the institutional laboratories. This impending danger has dramatically disharmonized the expected cordial relationship that existed among them. This is not so in most developed countries.[5 6] For example, the American Society for Clinical Pathology (ASCP) has homogeny in work relationship among pathologists and scientist. In conclusion, it is imperative that institutional laboratories in Africa should advocate and strive towards having QA in spite of the so many challenges. However, these challenges can be surmounted if ASLM, PEPFAR, IAP, ASCP, ADASP, and other agencies including the WHO collaborate effectively to enhance standardized laboratory practice that would eventually transform African laboratories to produce efficient and high quality results that can stand the test of time globally.