Access to pathology and laboratory medicine services: a crucial gap

The Lancet

Volumn 391, Issue 10133, 2018, Pages 1927-1938

  Wilson, Michael L ^a   Fleming, Kenneth A ^b,c   Kuti, Modupe A ^d   Looi, Lai Meng ^e   Lago, Nestor ^f   Ru, Kun ^g  

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^b NATIONAL CANCER INSTITUTE   (United States)

^c UNIVERSITY OF OXFORD   (United Kingdom)

^d UNIVERSITY OF IBADAN   (Nigeria)

^e UNIVERSITY OF MALAYA   (Malaysia)

^f UNIVERSIDAD DE BUENOS AIRES   (Argentina)

^g INSTITUTE OF HEMATOLOGY AND BLOOD DISEASES HOSPITAL   (China)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; AUTOPSY; CANCER SCREENING; DISEASE BURDEN; DISEASE REGISTRY; DISEASE SURVEILLANCE; HEALTH CARE ACCESS; HEALTH CARE QUALITY; HUMAN; LABORATORY; LOW INCOME COUNTRY; MEDICAL EDUCATION; MEDICOLEGAL ASPECT; MIDDLE INCOME COUNTRY; PATHOLOGY; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PROGNOSIS; REVIEW; TREATMENT PLANNING; CLINICAL LABORATORY SERVICE; DEVELOPING COUNTRY; HEALTH EDUCATION; HEALTH SERVICE; HEALTH SURVEY; INSURANCE; MANPOWER; PUBLIC HEALTH; STANDARDS;

CLINICAL LABORATORY SERVICES; DEVELOPING COUNTRIES; HEALTH EDUCATION; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; POPULATION SURVEILLANCE; PUBLIC HEALTH; QUALITY OF HEALTH CARE; UNIVERSAL COVERAGE;

EID: 85043510227     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(18)30458-6     Document Type: Review

References (103)

1. Carter, JY, Lema, OE, Wangai, MW, Munafu, CG, Rees, PH, Nyamongo, JA, Laboratory testing improves diagnosis and treatment outcomes in primary health care facilities. Afr J Lab Med 1 (2012), 1–6.
2. Petti, CA, Polage, CR, Quinn, TC, Ronald, AR, Sande, MA, Laboratory medicine in Africa: a barrier to effective health care. Clin Infect Dis 42 (2006), 377–382.
3. WHO. Global health estimates 2015: deaths by cause, age, sex, by country and by region, 2000–2015. http://www.who.int/healthinfo/global_burden_disease/estimates/en/index1.html, 2016 (accessed July 29, 2017).
4. UN. Transforming our world: the 2030 agenda for sustainable development. 2015, United Nations, Department of Economic and Social Affairs, New York.
5. Islam, SMS, Purnat, TD, Phuong, NTA, Mwingira, U, Schacht, K, Fröschl, G, Non-communicable diseases (NCDs) in developing countries: a symposium report. Global Health, 10, 2014, 81.
6. World Bank. 2017 world development indicator maps. https://data.worldbank.org/products/wdi-maps, 2017 (accessed Oct 2, 2017).
7. Cost-effective strategies for the excess burden of disease in developing countries. Jamison, DT, Breman, JG, Measham, AR, et al. (eds.) Priorities in health, 2006, The International Bank for Reconstruction and Development / The World Bank, Washington, DC.
8. WHO. Global status report on noncommunicable diseases. http://www.who.int/nmh/publications/ncd_report_full_en.pdf, 2010 (accessed Oct 5, 2017).
9. WHO, Global Health Workforce Alliance. Global health workforce crisis key messages—2013. http://www.who.int/workforcealliance/media/KeyMessages_3GF.pdf, 2013 (accessed Oct 14, 2017).
10. GBD 2015 Mortality and Causes of Death Collaborators. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet 388 (2015), 1459–1544.
11. WHO. In vitro diagnostics and laboratory technology: contributions to Millennium Development Goals. http://www.who.int/diagnostics_laboratory/3by5/en/, 2017 (accessed May 5, 2017).
12. Sayed, S, Cherniak, W, Tan, SY, et al. Improving pathology and laboratory medicine in low-income and middle-income countries: roadmap to solutions. Lancet, 2018 published online March 15. http://dx.doi.org/S0140-6736(18)30459-8.
13. Horton, S, Sullivan, R, Flanigan, J, et al. Delivering modern, high-quality, affordable pathology and laboratory medicine to low-income and middle-income countries: a call to action. Lancet, 2018 published online March 15. http://dx.doi.org/S0140-6736(18)30460-4.
14. Institute of Medicine. Improving diagnosis in health care: quality chasm series. http://www.nationalacademies.org/hmd/∼/media/Files/Report%20Files/2015/Improving-Diagnosis/DiagnosticError_ReportBrief.pdf, 2015 (accessed Oct 14, 2017).
15. Reyburn, H, Mbatia, R, Drakeley, C, et al. Over diagnosis of malaria in patients with severe febrile illness in Tanzania: a prospective study. BMJ, 329, 2004, 1212.
16. D'Acremont, V, Kilowoko, M, Kyungu, E, et al. Beyond malaria—causes of fever in outpatient Tanzanian children. N Engl J Med 370 (2014), 809–817.
17. Rohr, UP, Binder, C, Dieterle, T, et al. The value of in-vitro diagnostic testing in medical practice: a status report. PLoS One, 11, 2016, e0149856.
18. Pien, BC, Sundaram, P, Raoof, N, et al. The clinical and prognostic importance of positive blood cultures in adults. Am J Med 123 (2010), 819–828.
19. Dawood, S, Broglio, K, Buzdar, AU, Hortobagyi, GN, Giordano, SH, Prognosis of women with metastatic breast cancer by HER2 status and trastuzumab treatment: an institutional-based review. J Clin Oncol 28 (2010), 92–98.
20. Khoury, T, Sait, S, Hwang, H, et al. Delay to formalin fixation effect on breast biomarkers. Mod Pathol 22 (2009), 1457–1467.
21. Srigley, J, Lankshear, S, Brierley, J, et al. Closing the quality loop: facilitating improvement in oncology practice through timely access to clinical performance indicators. J Oncol Pract 9 (2013), e255–e261.
22. Amin, M, Boccon-Gibod, L, Egevad, L, et al. Prognostic and predictive factors and reporting of prostate carcinoma in prostate needle biopsy specimens. Scand J Urol Nephrol Suppl 216 (2005), 20–33.
23. Gopal, S, Krysiak, R, Liomba, NG, et al. Early experience after developing a pathology laboratory in Malawi, with emphasis on cancer diagnoses. PLoS One, 8, 2013, e70361.
24. Polage, CR, Bedu-Addo, G, Owusu-Ofori, A, et al. Laboratory use in Ghana: physician perception and practice. Am J Trop Med Hyg 75 (2006), 526–531.
25. Wilson, ML, Improving malaria treatment by increasing access to accurate diagnostic tests: test results must guide treatment. BMJ Evid Based Med, 19, 2014, 233.
26. Fung, MK, Gorssman, BJ, Hillyer, CD, Westhoff, CM, (eds.) Technical manual, 18th edn., 2014, American Association of Blood Banks, Bethesda, MD.
27. Kralievits, KE, Raykar, NP, Greenberg, SLM, Meara, JG, The global blood supply: a literature review. Lancet, 385(suppl 2), 2015, S28.
28. Ministry of Health, Federal Democratic Republic of Ethiopia. National blood transfusion services strategy. http://ont.es/SiteCollectionDocuments/afrlegethETH.pdf, 2005 (accessed Oct 4, 2017).
29. WHO Country Office for Ethiopia. Blood safety progress in 2014. http://www.afro.who.int/sites/default/files/2017-05/ethiopia_update-sheet-on-blood-safety_2014_final.pdf, 2015 (accessed Oct 4, 2017).
30. WHO Regional Office for Africa. Policy-makers in Ethiopia had a Forum to ensure an effective national blood transfusion system. http://www.afro.who.int/news/policy-makers-ethiopia-had-forum-ensure-effective-national-blood-transfusion-system, 2017 (accessed Oct 4, 2017).
31. Olson, B, Gribble, B, Dias, J, et al. Cervical cancer screening programs and guidelines in low- and middle-income countries. Int J Gynecol Obstet 134 (2016), 239–246.
32. van Rosmalen, J, de Kok, I, van Ballegooijen, M, Cost-effectiveness of cervical cancer screening: cytology versus human papillomavirus DNA testing. BJOG 119 (2012), 699–709.
33. Jin, XW, Lipold, L, Foucher, J, et al. Cost-effectiveness of primary HPV testing, cytology and co-testing as cervical cancer screening for women above age 30 years. J Gen Intern Med 31 (2016), 1338–1344.
34. Meggiolaro, A, Unim, B, Semyonov, L, Miccoli, S, Maffongelli, E, La Torre, G, The role of Pap test screening against cervical cancer: a systematic review and meta-analysis. Clin Ter 167 (2016), 124–139.
35. Branca, M, Longatto-Filho, A, Recommendations on quality control and quality assurance in cervical cytology. Acta Cytol 59 (2015), 361–369.
36. Carozzi, FM, Del Mistro, A, Cuschieri, K, Frayle, H, Sani, C, Burroni, E, HPV testing for primary cervical screening: laboratory issues and evolving requirements for robust quality assurance. J Clin Virol 76:suppl 1 (2016), S22–S28.
37. Arbyn, M, Depuydt, C, Benoy, I, et al. VALGENT: a protocol for clinical validation of human papillomavirus assays. J Clin Virol 76:suppl 1 (2016), S14–S21.
38. Hewitson, P, Glasziou, P, Watson, E, Towler, B, Irwig, L, Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol 103 (2008), 1541–1549.
39. Lin, JS, Piper, MA, Perdue, LA, et al. Screening for colorectal cancer: a systematic review for the US Preventive Services Task Force. Evidence synthesis no. 135. 2016, Agency for Healthcare Research and Quality, Rockville, MD.
40. Imperiale, TF, Ransohoff, DF, Itzkowitz, SH, Turnbull, BA, Ross, ME, Colorectal Cancer Study Group. Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population. N Engl J Med 351 (2004), 2704–2714.
41. Imperiale, TF, Ransohoff, DF, Itzkowitz, SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 370 (2014), 1287–1297.
42. US Preventive Services Task Force. Colorectal cancer screening recommendations. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/colorectal-cancer-screening2, 2016 (accessed June 16, 2017).
43. Brierley, J, Srigley, JR, Yurcan, M, et al. The value of collecting population-based cancer stage data to support decision-making at organizational, regional and population levels. Healthc Q 16 (2013), 27–33.
44. Ellis, DW, Srigley, J, Does standardised structured reporting contribute to quality in diagnostic pathology? The importance of evidence-based datasets. Virchows Arch 468 (2016), 51–59.
45. Chan, KCA, Woo, JKS, King, A, et al. Analysis of plasma Epstein-Barr virus DNA to screen for nasopharyngeal cancer. N Engl J Med 377 (2017), 513–522.
46. The Lancet Global Health. Global health security: how can laboratories help?. Lancet Glob Health, 5, 2017, e115.
47. Balajee, SA, Arthur, R, Mounts, AW, Global health security: building capacities for early event detection, epidemiologic workforce, and laboratory response. Health Secur 14 (2016), 424–432.
48. Petersen, LR, Carson, PJ, Biggerstaff, BJ, Custer, B, Borchardt, SM, Busch, MP, Estimated cumulative incidence of West Nile virus infection in US adults, 1999–2010. Epidemiol Infect 141 (2013), 591–595.
49. Ngatu, NR, Kayembe, NJM, Phillips, EK, et al. Epidemiology of Ebola virus disease (EVD) and occupational EVD in health care workers in Sub-Saharan Africa: need for strengthened public health preparedness. J Epidemiol 27 (2017), 455–461.
50. Broadhurst, MJ, Brooks, TJG, Pollock, NR, Diagnosis of Ebola virus disease: past, present, and future. Clin Microbiol Rev 29 (2016), 773–793.
51. Weaver, SC, Costa, F, Garcia-Blanco, MA, et al. Zika virus: history, emergence, biology, and prospects for control. Antiviral Res 130 (2016), 69–80.
52. Centers for Disease Control and Prevention. Facts about the laboratory response network. https://emergency.cdc.gov/lrn/factsheet.asp, 2014 (accessed Oct 4, 2017).
53. WHO. Antimicrobial resistance: global report on surveillance. 2014, World Health Organization, Geneva.
54. WHO. Worldwide country situation analysis: response to antimicrobial resistance. 2015, World Health Organization, Geneva.
55. Musicha, P, Cornick, JE, Bar-Zeev, N, et al. Trends in antimicrobial resistance in bloodstream infection isolates at a large urban hospital in Malawi (1998–2016): a surveillance study. Lancet Infect Dis 17 (2017), 1042–1052.
56. Cross, A, Levine, MM, Patterns of bacteraemia aetiology. Lancet Infect Dis 17 (2017), 1005–1006.
57. van Ingen, J, Kohl, TA, Kranzer, K, et al. Global outbreak of severe Mycobacterium chimaera disease after cardiac surgery: a molecular epidemiological study. Lancet Infect Dis 10 (2017), 1033–1041.
58. Diabetes Collaborative Registry. Transforming the future of diabetes care. https://www.ncdr.com/WebNCDR/Diabetes/publicpage, 2017 (accessed Oct 2, 2017).
59. The Diabetes Collaborative Registry. Data collection form v1.2. https://www.ncdr.com/WebNCDR/docs/default-source/Diabetes-Public-Documents/diabetesdatacollectionform.pdf?sfvrsn=12, 2015 (accessed Oct 2, 2017).
60. National Institutes of Health. NIH clinical research trials and you: list of registries. https://www.nih.gov/health-information/nih-clinical-research-trials-you/list-registries, 2016 (accessed Oct 2, 2017).
61. Kuijpers, CC, Fronczek, J, van de Goot, FR, Niessen, HW, van Diest, PJ, Jiwa, M, The value of autopsies in the era of high-tech medicine: discrepant findings persist. J Clin Pathol 67 (2014), 512–519.
62. Hernández, B, Ramírez-Villalobos, D, Romero, M, Gómez, S, Atkinson, C, Lozano, R, Assessing quality of medical death certification: concordance between gold standard diagnosis and underlying cause of death in selected Mexican hospitals. Popul Health Metr, 9, 2011, 38.
63. Cox, JA, Lukande, RL, Nelson, AM, et al. An autopsy study describing causes of death and comparing clinic-pathological findings among hospitalized patients in Kampala, Uganda. PLoS One, 7, 2012, e33685.
64. Wiredu, EK, Armah, HB, Cancer mortality patterns in Ghana: a 10-year review of autopsies and hospital mortality. BMC Public Health, 6, 2006, 159.
65. McCaw-Binns, A, Holder, Y, Mullings, J, Certification of coroners cases by pathologists would improve the completeness of death registration in Jamaica. J Clin Epidemiol 68 (2015), 979–987.
66. Nelson, AM, Milner, DA, Rebbeck, TR, Iliyasu, Y, Oncologic care and pathology resources in Africa: survey and recommendations. J Clin Oncol 34 (2016), 20–26.
67. Royal College of Pathologists. First annual medical workforce planning report 2015. https://www.rcpath.org/resourceLibrary/first-annual-medical-workforce-report–2015.html, 2015 (accessed July 29, 2017).
68. Lee, EY, Yu, E, Ro, JY, The 14th spring seminar of the Korean Pathologists of North America. Arch Pathol Lab Med 140 (2016), 394–396.
69. Sawai, T, Uzuki, M, Karmataki, A, Tofukuji, I, The state of telepathology in Japan. J Pathol Inform, 1, 2010, 13.
70. Hsu, CY, Jung, SM, Chuang, SS, Physician supply and demand in anatomical pathology in Taiwan. J Formosan Med Assoc 110 (2011), 78–84.
71. Royal College of Pathologists. Specialist registration. https://www.rcpath.org/trainees/training/specialist-registration.html, 2017 (accessed June 17, 2017).
72. Royal College of Pathologists. Continuing professional development. https://www.rcpath.org/profession/professional-standards/cpd.html, 2017 (accessed June 17, 2017).
73. American Board of Pathology. To become certified: definitions. http://www.abpath.org/index.php/to-become-certified/definitions, 2015 (accessed 17 June, 2017).
74. American Board of Pathology. Maintenance of certification. http://www.abpath.org/index.php/maintenance-of-certification-moc, 2015 (accessed June 17, 2017).
75. Malaysian National Specialist Register. Anatomical pathology. https://www.nsr.org.my/qualifications1.html#ANATOMICALPATHOLOGY, 2013 (accessed June 17, 2017).
76. WHO. Transforming and scaling up health professionals' education and training: guidelines 2013. http://apps.who.int/iris/bitstream/10665/93635/1/9789241506502_eng.pdf, 2013 (accessed June 17, 2017).
77. Association of American Medical Colleges. Active physicians in the largest specialties, 2015. https://www.aamc.org/data/workforce/reports/458480/1-1-chart.html, 2015 (accessed June 17, 2017).
78. National Resident Matching Program. Results and data: 2017 main residency match. https://mk0nrmpcikgb8jxyd19h.kinstacdn.com/wp-content/uploads/2017/06/Main-Match-Results-and-Data-2017.pdf, 2017 (accessed July 30, 2017).
79. Canadian Resident Matching Service. 2016 R-1 main residency match report. http://carms.ca/wp-content/uploads/2016/06/2016-R1-match-report-full-EN.pdf, 2016 (accessed July 30, 2017).
80. General Medical Council. The state of medical education and practice in the UK: our data on doctors working in the UK. http://www.gmc-uk.org/SoMEP_2016_Chapter_one.pdf_68138039.pdf, 2016 (accessed July 30, 2017).
81. Mullan, F, Frehywot, S, Omaswa, F, et al. Medical schools in sub-Saharan Africa. Lancet 377 (2011), 1113–1121.
82. Chen, C, Buch, E, Wassermann, T, et al. A survey of Sub-Saharan African medical schools. Hum Resour Health, 10, 2012, 04.
83. Robboy, SJ, Gupta, S, Crawford, JM, et al. The pathologist workforce in the United States. II. An interactive modeling tool for analyzing future qualitative and quantitative staffing demands for services. Arch Pathol Lab Med 139 (2015), 1413–1430.
84. Kasvosve, I, Ledikwe, JH, Phumaphi, O, et al. Continuing professional development training needs of medical laboratory personnel in Botswana. Hum Resour Health, 12, 2014, 46.
85. Mwaikambo, L, Ohkubo, S, Cassaniti, J, Collaborative learning and stakeholder engagement: lessons and implications of the revitalization of the Continuing Professional Development policy for health workers in Nigeria. Knowl Manag Develop J 9 (2013), 63–78.
86. Ndihokubwayo, JB, Francis, KF, Yahaya, AA, Mwenda, J, Strengthening public health laboratories in the WHO African Region: a critical need for disease control. WHO Regional Office for Africa. http://who.insomnation.com/sites/default/files/pdf/ahm12-page-47-52-phl-in-afr.pdf, 2010 (accessed Feb 5, 2018).
87. Fonjungo, PN, Kebede, Y, Messele, T, et al. Laboratory equipment maintenance: a critical bottleneck for strengthening health systems in sub-Saharan Africa?. J Public Health Pol 33 (2012), 34–45.
88. Alemnji, GA, Branch, S, Best, A, et al. Strengthening national laboratory health systems in the Caribbean region. Glob Public Health 7 (2012), 648–660.
89. Royal College of Pathologists. The regulatory landscape for pathology services. https://www.rcpath.org/resourceLibrary/the-regulatory-landscape-for-pathology-services.html, 2017 (accessed June 17, 1017).
90. Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments (CLIA). https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/CLIA/, 2017 (accessed June 17, 2017).
91. Ali, M, Elbireer, AM, Jackson, JB, et al. The good, the bad, and the unknown: quality of clinical laboratories in Kampala, Uganda. PLoS One, 8, 2013, e64661.
92. Amukele, TK, Schroeder, LF, Jackson, JB, Elbireer, A, Most clinical laboratory testing in Kampala occurs in high-volume, high-quality laboratories or low-volume, low-quality laboratories. Am J Clin Pathol 143 (2015), 50–56.
93. Wattanasri, N, Manoroma, W, Viriyayudhagorn, S, Laboratory accreditation in Thailand: a systemic approach. Am J Clin Pathol 134 (2010), 534–540.
94. Looi, LM, The Pathology Laboratory Act 2007 explained. Malaysian J Pathol 30 (2008), 1–10.
95. Kenya Accreditation Service. Medical laboratories. http://kenas.go.ke/our-services/medical-laboratories/, 2017 (accessed June 17, 2017).
96. Carter, JY, External quality assessment in resource–limited countries. Biochemia Medica 27 (2017), 97–109.
97. International Standards Organization. Medical laboratories: requirements for quality and competence. https://www.iso.org/standard/56115.html, 2014 (accessed July 29, 2017).
98. Joint Commission International. Accreditation standards for laboratories. http://www.jointcommissioninternational.org/jci-accreditation-standards-for-laboratories-3rd-edition-english-version-pdf-book-/, 2016 (accessed June 17, 2017).
99. Ndihokubwayo, JB, Maruta, T, Ndlovu, N, et al. Implementation of the World Health Organization regional office for Africa stepwise laboratory quality improvement process towards accreditation. Afr J Lab Med, 5, 2016, a280.
100. Gershy-Damet, GM, Rotz, P, Cross, D, et al. The World Health Organization African region laboratory accreditation process: improving the quality of laboratory systems in the African region. Am J Clin Pathol 134 (2010), 393–400.
101. Dasgupta, P, The shameful frailty of the rural healthcare system in India. https://futurechallenges.org/local/the-frailty-of-rural-healthcare-system-in-india/, 2016 (accessed June 22, 2017).
102. Dzau, V, Fuster, V, Frazer, J, Snair, M, Investing in global health for our future. N Engl J Med 377 (2017), 1292–1296.
103. Centre for International Economics. The economic value of pathology: achieving better health, and a better use of health resources. http://www.thecie.com.au/wp-content/uploads/2016/04/Economic-value-of-pathology_-Final-Report-April-2016.pdf, 2016 (accessed May 12, 2016).