ROLLING BACK THE HIV EPIDEMIC: THE CRITICAL ROLE OF THE LABORATORY. NASCOP CME 22 nd June 2012 Dr Jessie Githang a, Pathologist/Haematolo gistuon
Scenario 1 WN a 28 year old female with HIV presents with weight loss and a cough for 3 weeks productive of bloody sputum She is sent for sputum smear examination which is reported as Positive for AFB Anti-TB treatment initiated however there is no clinical improvement at all after several months Repeat smear for AFB reported negative, sent for culture
CXR for WN
Scenario 1 cont. Sent for guided FNAB large cell NHL Culture results (8 weeks later) No AFB What went wrong??
Scenario 2 FM a 34 year old male has been on treatment for HIV for the last 1 year and has been doing well with CD4 counts of 650/mm 3 at 1 year post treatment initiation. At last visit 6 monthly visit CD4 count reported 100/mm 3 despite his otherwise well being What would you do? Repeat CD4 a week afterwards reported 600/mm 3 What went wrong??
Overview Role of Laboratory services in healthcare Kenyan situation Challenges in provision of quality laboratory services Ending the neglect Strategies for overcoming the challenges Strides made in Kenya
Role of laboratory services in health care Medical laboratory services are a critical component of essential health systems in RPC Central role in public health, disease control, surveillance, individual patient diagnosis and care. Key component for achievement of the health MDGs; Vision 2030 medical goals Essential for fight against HIV/AIDS, TB, malaria etc Link between the clinician and the patient
THE 3 PILLARS Disease prevention, control and patient management Public health Laborator y medicine Clinical medicine
Neglect of laboratory services Majority of the population do not have access to reliable, basic, diagnostic laboratory services. Neglect of laboratories by Government International organizations Civil society
State of the Art Laboratory
Health Care Financing in Kenya (2009/10) Total health spending as a % of GDP: 5.4% of GDP Government spending on health as % of GDP: 1.5% Public spending on health: US$12 per capita or 4.6% of general government expenditure (declining) Public (63.3%) Private (36.7%) Government = 21.8% Direct = 28% External = 34.5% Private health insurance = 3% NHIF = 7% (population coverage=20%) Other private expenditure = 5.7% Elkana Ong uti, Chief Economist MOMS
Accredited Laboratories in Africa (Total = 370) SSA 28 SA 8.2% 91.8 % N= 30 Public Labs 9.6% Private Labs 90.4% N=340 N= 282
Challenges in provision of quality laboratory services HIV & AIDS and TB epidemics placed a huge burden on national healthcare system and laboratory services Lack of effective policies & laboratory leadership, weak management Lack of national laboratory policy, strategic plan, dedicated budget for laboratories Human resource crisis - insufficient suitably trained laboratory staff, low morale, poor retention
Challenges cont. Inadequate infrastructure (electricity, water, environment, physical space) Lack of equipment, poor maintenance Lack of effective QA programmes Inadequate supply chain management for reagents, consumables Lack of effective referral Networks Bates I, Maitland K. Clin Infect Dis. 2006;42:383-384. Petti CA, et al. Clin Infect Dis. 2006;42:377-382.
Consequences of suboptimal lab services Clinician lack of confidence in results Rely on clinical diagnosis, give empirical/syndromic treatment Results in misdiagnosis/overdiagnosis; inadequate or inappropriate treatment; drug resistance and increased mortality Studies in Tanzania have shown that patients treated for malaria <50% actually had smear positive malaria 1 In Malawi, 40% of patients treated for malaria actually had bacterial sepsis 2 1. Rayburn et al 2004; 2. Evans et al 2004
Has this appalling situation recently changed? Realization of the crucial role that laboratories play in fighting HIV & AIDS, TB and malaria Increase in funding sources President Obama s GHI Global Fund to Fight AIDS, TB and Malaria PEPFAR World Bank s laboratory strengthening efforts in EA McCoy D et al. Health Policy. 2009;24:407-417 Ravishankar N et al. Lancet. 2009;373:2113-2124..
Ending the neglect Donor-funded laboratory strengthening efforts initially focused on developing appropriate technologies, equipment, supplies, technical training Neglect of management and leadership strengthening essential for leveraging financial inputs for sustained enhanced laboratory performance
Ending the neglect cont. Potential threat: Strong vertical programs concerned with HIV care/management focusing on HIV-related aspects of lab services Focus on strengthening lab systems as part of overall health systems strengthening Integration of lab aspects of HIV programs to strengthen existing systems and build capacity
Efforts made Jan 2008 - Maputo declaration To strengthen laboratories in developing countries 33 countries, WHO, World Bank, Global fund for AIDS, TB, Malaria April 2008 - Lyon France WHO, CDC : Staged approach towards accreditation Sept 2008 - Yaoundé Cameroon Resolution AFR/RC58/R2, to strengthen public health laboratories in the WHO African region
Efforts made cont. September 2008 - Dakar, Senegal Regional HIV/AIDS Network for Public Health Laboratories - to broaden scope beyond HIV/AIDS July 2009 - Kigali, Rwanda WHO AFRO, CDC, the Clinton Health Access Initiative, the ASCP, others - launched a stepwise laboratory accreditation process September 2009 - Kigali, Rwanda Resolutions for the strengthening of public health labs and other centers of excellence to improve disease prevention and control. World Bank. http://go.worldbank.org/jzdnoh6zd0.
Act now, act collectively, act differently Act now and decisively to end neglect of laboratory systems and services Act collectively - Partnerships to establish/strengthen sustainable integrated tiered lab systems and networks Act differently with shifted paradigms to maximize funding and focus on strengthening health systems Adapted from Nkengasong JN. Am J Clin Pathol134 359-
Acting now. Quality laboratory services and systems are the foundation for health systems strengthening Primary goal of the laboratory is provision of information critical for medical decision making Use the vast increased funding for global health to end neglect of public laboratories Kigali meeting (July 2009) launched SLMTA and WHO AFRO Accreditation Process Gershey-Damet GM et al. Am J Clin Pathol134 393-400
WHO AFRO accreditation scheme: Stepwise recognition of laboratory performance. 4 Stars 5 Stars >95% End Point ISO 15189 CAP, SANAS JCI, SADCAS 3 Stars 85 94% 2 Stars 75 84% 65 74% 1 Star 55-64%
Acting collectively: Effective Partnerships Quality services to meet program goals Sustainable, integrated, functional, tiered laboratory systems and networks Operationa l research
Acting differently. To maximize funding for global health development and strengthen health systems: Paradigm shift with clear indicators No. of labs accredited in the public health sector Indices measuring progress for strengthening laboratory systems and networks. Private Public Partnerships Alemnji G et al. 2011. Indian J Med Res 134; 779-786
National Laboratory Capacity Networks Ministry of Health National Reference Laboratories Preventi on Research Treatment Programs Regional Laboratories District Laboratories Health Centres Common Interphas e
Focus on the known do nothing gaps Bridging the gap between laboratory medicine and clinicians through continuous medical lab education Strengthening professional bodies e.g. ASLM Implementation of competency and task-based management programs (SLMTA) Implementation of mentorship programs Development of local capacity and indigenous partners to ensure sustainability (including PPP) Nkengasong et al 2010
Strides made in Kenya Article 43. (1) (a) Every person has the right to the highest attainable standards of health Kenya participating in the East Africa Regional Public Health Laboratory Networking Project Policy Formulation : KEMSA Bill 2012 Embraced step-wise accreditation process 13 public laboratories in the initial phase 3 national labs, 7 labs in provincial hospitals, 3 high volume labs in district hospitals.
Progress on Commodity Management Policy/Quality Assurance/Facility Level in Kenya Products Quality Assurance Related policies Essential product lists Reforms at the facility level WHO AFRO Step-wise accreditati on SLMTA Draft Lab policy 2011 & strategic plan Draft Lab Equipment Policy Draft Lab Lists Push - pull system (demand driven) Capacity building Improving storage
Conclusion The neglect of medical laboratories is coming to an end There is now a monumental opportunity to build integrated and sustainable NLSs which will help advance the goals of the MDGs for health, support universal access to treatment This calls for sustained action by all development partners acting NOW, acting COLLECTIVELY but acting DIFFERENTLY