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Advances in National Laboratory Strategic Planning in Africa Improves Quality of Services: A
PEPFAR Major Success Story
John Nkengasong, PhD
Associate Director of Laboratory ScienceDivision of Global HIV/AIDS, Center for Global Health
Center for Disease Control and Prevention
APHL Annual MeetingJune 1, 2014
Center for Global HealthThis image cannot currently be displayed.
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A Decade of Commitment to Strengthening Laboratory Medicine in
PEPFAR-Supported Countries
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Outline
• Introduction• Role of Laboratory Strategic Plan• Laboratory Systems• Need to strengthen Institutions
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CDC PEPFAR-Supported Countries
PEPFAR 10 Year Goals:– Treatment for at least
6 million people – Prevention of 12
million new infections – Care for 12 million,
including 5 million orphans and vulnerable children
– Training of at least 140,000 new health care workers in HIV/AIDS
Countries with HIV/AIDS program offices (N=41)Additional countries receiving HIV/AIDS support (N=37)
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1.93.7
7.2
12.7
21.6
28.5
32.8
40.5
49.0
57.7
0
10
20
30
40
50
60
70
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Mill
ions
HIV Testing Offered In PEPFAR-SupportedCountries Between 2004-2013
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0.07 0.25 0.51.1
1.7
2.53.2
3.9
5.1
6.7
0
1
2
3
4
5
6
7
8
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Mill
ions
Number Of HIV-Infected Adults And Children Receiving Antiretroviral Therapy
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The Case For Strengthening Laboratory Systems
Neglected Lab Infrastructure
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State Of Laboratories Infrastructure In 2004
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Need To Renovate Laboratories To Support The Treatment And Prevention Programs
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The Renovated Laboratory
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The Inauguration
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State Of Reference Laboratories In 2014Dar es Salaam,TanzaniaChennai, India
Addis Ababa, Ethiopia
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IOM Report on Evaluation of PEPFAR
“Although challenges remain, the improvement of laboratories under PEPFAR support and guidance has been a signature achievement of the program ----During the committee’s country visits, this was a theme emphasized with near universality”
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Vision and Mission Statement
To support countries to strengthen sustainable, integrated laboratory systemsto provide diagnostics services for effective implementation of prevention, surveillance and treatment programs across disease (HIV, TB, Malaria, OI’s, etc.)
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Serology MolecularTesting CD4 ChemistryHematologyCultureMicroscopy
Laboratory Systems
Laboratory Services
PEPFAR Laboratory Framework For Multiple Diseases
Quality Management
Workforce DevelopmentBiosafety &
EQP MaintenanceSupply Chain Management
Laboratory Information
Sample Referral
Facilities/Policies
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Institutions
Systems
Services
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Services
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0
50
100
150
200
250
300
350
400
Number Of PEPFAR-Supported Laboratories In Selected Countries As Of September 2008 (N= 1,917)
53
10
117
371
6697
30 36
311
254274
150
250
141100
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Dried Blood Spot-based PCR Testing Has Helped Scale-up Early Infant Diagnosis
0
20
40
60
80
100
120
Num
ber
LaboratoryParticipationCountry Participation
Scaling up DBS-PCR testing in developing countries
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Systems
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`
`
The Maputo Declaration on Strengthening of Laboratory SystemsRecognize that in order to improve and sustain access to laboratory services, there must be an integration of laboratory support for tuberculosis, malaria and HIV disease programs. The aim of this effort should be to sustain any improvements made to a laboratory as part of the greater health system from a public health perspective.
Call on national governments to support laboratory systems as a priority by developing a national laboratory policy within the national health development plan that will guide the implementation of a national strategic laboratory plan. Governments should establish a department of laboratory systems within the Ministry of Health.
Call on donors and implementing partners to ensure that in supporting laboratory strengthening that proper consideration is given to fostering national ownership.
Call on academic institutions and research funders to accelerate efforts to develop new diagnostic tools applicable to resourced-limited settings.
Call on donors and development partners to commit to work collaboratively with each other and with coordination from the national governments to support strengthening of laboratory systems in order to create one unified, integrated national laboratory network. These laboratory strengthening efforts should seek to build public private partnerships.
Done in Maputo, Mozambique on 24 January 2008
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Development of National Strategic Laboratory Plan in PEPFAR-Supported Countries (N=25)
Country Engaged in Discussion
Coordinating & Technical Committees
FormedStrategic Plan
DevelopedStrategic Plan Implemented
Strategic Plan Progress Reviewed &
Evaluated
Cote d’IvoireEthiopia
Guyana
KenyaLesotho
Mozambique
NigeriaRwandaSwaziland
UgandaVietnam
TanzaniaSouth Africa
Namibia
Malawi
Haiti
Cambodia
Ghana
Cameroon
BotswanaBarbados
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Kigali, Rwanda – 2009
1. Roadmap to accreditation and framework to measure progress2. Training program to improve laboratory quality management
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WHO-AFRO Stepwise Laboratory Quality Improvement Process Towards Accreditation
55-64 %
65-74 %
75-84 %
85-94 %
≥ 95 %
1 Star
5 Stars
2 Stars
3 Stars
4 Stars
0 Stars
Benchmarks a laboratory’s progress towards accreditation
using a 0-to-5 star scale
Audit checklist based on ISO 15189
standard
Strengthening Laboratory Management Toward Accreditation
Training program to improve laboratory quality management
Workshops, Mentorship, Improvement Projects, Audits
(12-18 months)
Workshop #1
Workshop #2
Workshop #3
Behavioral Changes & Laboratory
Improvement
BaselineAudit
Exit Audit
SiteVisits
SiteVisit
s
SiteVisits
Improvement Projects
(3 months)
Improvement Projects
(3 months)
Improvement Projects
(3 months)
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Total
Countries 39
Laboratories 501
Trainers 433
People trained 1644
Africa (N=23)
South East Asia (N=2)
Latin America and the Caribbean (N=14)
Global Reach Of The SLMTA Program
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0 Stars
5 Stars
3 Stars
2 Stars
1 Star
Score0-24%
Score 45-54%
Score 35-44% Score
25-34%
0 Stars
5 Stars
3 Stars
2 Stars
1 Star
4 Stars
Score 45-54%
Score 35-44%
Score 25-34%
96 Million Tests Conducted Annually in 501 SLMTA Laboratories
Before SLMTA16% of tests done in laboratories
with at least 1 star
After SLMTA67% of tests done in laboratories
with at least 1 star
SLMTA Results
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Personnel Files
Signage
Documents & Records
Evidence of Laboratory Improvement
Laboratory Floor Plan Redesign
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Recognition!
Kenya receiving ISO15189 - 2013
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Source: Schroeder LF et al, American Journal of Clinical Pathology (in press)
Accredited Laboratories in Sub-Saharan Africa
Only 34 laboratories accredited outside of SA (2 public labs)
37 of 49 countries have NO accredited laboratories
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•National Health Laboratory Quality Assurance and Training Centre)•Muhimbili National Hospital, awaiting application
KCMC Referral Lab, awaiting application
Mbeya Referral Hospital
Mnazi mmoja Lab, assessed by SADCAS
Bugando lab
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Bamalete Lutheran Hospital Lab-Ramotswa
LEGEND4 State Reference Laboratories Accredited
1District Hospital Laboratory Accredited
5 MOH district /referral Laboratories under Accreditation Cycle
Nyamgagbwe HIV Ref Lab-Francistown
Harvard HIV Reference Lab-Gaborone
National TB Reference Lab-Gaborone
Princess Marina Hospital Lab-Gaborone
Nyamgagbwe Referal Hospital Lab-Francistown
BLH District Hospital Lab-Ramotswa
Map of Botswana Showing Accreditation Status of MOH Laboratories
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Map of India Showing Accreditation Status of National Reference Laboratories
MMC, Chennai
NCDC, New Delhi
LEGEND
8 National Reference Laboratories Accredited
2 National Reference Laboratories under Accreditation Cycle
AIMS, New Delhi
CMC, Vellore
NICED, Kolkata
NIMHANS, Bangalore
NARI, Pune
NIB, Noida
STM, Kolkata
IPM, Hyderabad
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Map of India Showing Accreditation Status of State Reference Laboratories
LEGEND5 State Reference Laboratories Accredited
10State Reference Laboratories under Accreditation Cycle
GMC, Surat
JJ Hospital, MumbaiKEM, Mumbai
LTMG Sion, Mumbai
BJMC, Ahmedabad
GMC, Hyderabad
PGIMER, Chandigarh
GHTM, Chennai
GMC, BarodaMPSMC jamnagar, Baroda
LHMC, New Delhi
BJMC, Pune
BYL, Mumbai
NHA, Kohima
HIMS , Dehradun
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Ho Chi Minh
Ha Noi
Vietnam ISO15189 Accredited Labs with CDC Support (PEPFAR Funding)
Preventive Medicine Center-HCMC, Microbiology Lab, Ho Chi Minh
Phan Ngoc Thach Hospital, Microbiology Lab, Ho Chi Minh
Pasteur Institute (HCMC), HIV Lab, Ho Chi Minh
Pasteur Institute (HCMC), HIV DR Lab, Ho Chi Minh
Bach Mai Hospital, Microbiology Lab, Hanoi
Hue Central Hospital, Microbiology Lab, Hue
National Institute of Hygiene and Epidemiology, HIV Lab, Hanoi
National Lung Hospital Microbiology Laboratory (Nat’l TB Reference Lab), Hanoi
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Serology MolecularTesting CD4 ChemistryHematologyCultureMicroscopy
Laboratory Systems
Laboratory Services
PEPFAR Laboratory Framework For Multiple Diseases
Quality Management
Workforce DevelopmentBiosafety &
EQP MaintenanceSupply Chain Management
Laboratory Information
Sample Referral
Facilities/Policies
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Strengthening Sample Transport Networks - Uganda • Initial pilot of 19 hubs reached 625health facilities.
• Scaled up to 60 hubs serving 1700 health facilities launched.
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Specimen Referral and Transport: Solutions
* Slide adapted from Moses Joloba, Uganda NTRL
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$2,312 $2,448
$1,700
$6,460
$792 $824 $812
$2,428
$0
$1,000
$2,000
$3,000
$4,000
$5,000
$6,000
$7,000
Masaka (68 parcels) Jinja (72 parcels) Gulu (50 parcels) Overall average (190 parcels)
Before NSRTN After NSRTN
62%
Sample Transport Costs For DBS Decreased By 62% After Setting Up The Sample Referral System
38
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Serology MolecularTesting CD4 ChemistryHematologyCultureMicroscopy
Laboratory Systems
Laboratory Services
PEPFAR Laboratory Framework For Multiple Diseases
Quality Management
Workforce DevelopmentBiosafety &
EQP MaintenanceSupply Chain Management
Laboratory Information
Sample Referral
Facilities/Policies
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TB, HIV, Malaria - Integrated laboratories, Zaria, Nigeria
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TB and HIV Labs in Chennai, India
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Serology MolecularTesting CD4 ChemistryHematologyCultureMicroscopy
Laboratory Systems
Laboratory Services
PEPFAR Laboratory Framework For Multiple Diseases
Quality Management
Workforce DevelopmentBiosafety &
EQP MaintenanceSupply Chain Management
Laboratory Information
Sample Referral
Facilities/Policies
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MissionTo provide integrated hand-on training courses to expand laboratory capacity in Africa for diagnosis and monitoring of major infectious diseases including HIV, TB and Malaria
• 1,136 Trainees• 39 Countries
African Centre For Integrated Laboratory Training At NHLS/NICD Johannesburg
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Source: IOM Report 2013
Human Resource Development for Laboratory
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Institutions & Public Private Partnerships
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Launch of the African Society for Laboratory Medicine
ASLM MISSIONTo advance professional laboratory medicine practice, science, systems and networks in Africa needed to support preventive medicine, quality care of patients and disease control through partnership with governments and relevant organizations.
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Ministers of Health at Launch of ASLM
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ASLM Regional Ambassador Program
ASLM Collaborating Centers
Dennis Agbonlahor (Nigeria) William Ampofo (Ghana)El-Hadj Belabbes (Algeria)Adil Ismail (Sudan) Mohamed Ally Mohamed (Tanzania)Jean Sakande (Burkina Faso)Daniel Sess (Cote d’Ivoire)
Ethiopian Health and Nutrition Research Institute (Ethiopia)Kenya Medical Research Institute (Kenya)Institute of Human Virology (Nigeria)West African Network Against AIDS, TB and Malaria (Senegal)National Health Laboratory Service (South Africa) National Health Laboratory Quality Assurance and Training Centre (Tanzania)
C
C
C
CC
A
A
A
A
AA
A C
African Society for Laboratory MedicineASLM Headquarters
Addis Ababa, Ethiopia
C
A
134 certified auditors
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The Power of Partnership - Public Private Partnerships are Critical for Laboratory Strengthening Efforts
$18 Million PEPFAR partnership with BD
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Conclusions And Key Lessons Learned1. Leadership and Commitment from Agency2. Strategic Partnerships and Relationships
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The Beginning of Famine?
At Front Lines, AIDS War Is Falling ApartBy DONALD G. McNEIL Jr.Published: May 9, 2010
As the Need Grows, the Money for AIDSRuns Far Short
By DONALD G. McNEIL Jr.Published: May 9, 2010
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Is the glass half full or half empty?
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Thank You
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Acknowledgements
CDC Implementing PartnersTom Hearn ASM ASLMAustin Demby USAID UNAIDSSherry Orloff CLSI APHLDebbi Birx AFENET ASCPTom Shinnick BD CHAIRon Ballard FIND WHOBob MartinJohn RidderhofMark RayfieldMOH colleagues