The Laboratories Role in Global Health

Transcription

1 The Laboratories Role in Global Health Larry Westerman, Ph.D. International Laboratory Branch Division of Global HIV/AIDS Centers for Disease Control and Prevention Center for Global Health International Lab Branch

2 Presentation Outline Background Challenges in Global Laboratory Strengthening Building an Environment for Quality Need for Laboratory Information Systems Opportunities for Improved Point-of-Care Testing Laboratory Advocacy

3 Laboratory Role in Global Health To provide access to laboratory testing, that are accurate and reliable Support programs and health care in diagnostic, care, and surveillance Contribute to and strengthen health-systems

4 Value of Laboratory Medicine to the Health Care System

5 Value of Laboratory Medicine to the Health Care System

6 Value of Laboratory Medicine to the Health Care System

7 Value of Laboratory Medicine to the Health Care System

8 Global Laboratory Challenges (Opportunities) Recognize the Importance of the Laboratory Lack of commitment to support Laboratory Systems Major issues in Laboratories in Resource-Limited Settings Personnel- lack of numbers, poorly trained, and incompetency Infrastructure needs- space, climate control, power, and water Equipment- lack of, poorly placed, service support, calibration Reagent and Supplies- lack of, poor inventory, forecasting, policy Biosafety and Biosecurity Policy and Plans

9 The Case for Lab Strengthening Neglected Lab Infrastructure

10 $15B from (15 highest-burden countries) $39B from (>40 countries) US government agencies provide support for PEPFAR CDC, USAID, NIH, Dept of Defense, Peace Corps CDC provides scientific and technical support Prevention Care and treatment for HIV and TB patients Laboratory diagnosis and bio-monitoring Health systems strengthening

11 US Global Health Initiative: $63B HIV TB Malaria Maternal and child health Health systems and workforce Neglected tropical diseases

12 Building a Culture for Quality in the Laboratory Challenges for Quality Assurance in Limit-Resource Lab Lack of or poor Laboratory Management National Policy and Plans for Laboratories No, inconsistent, or inappropriate Quality Control Testing Lack of supplies and non-functional equipment No Quality Assurance Programs In the Laboratory Monitoring Need to provide tools and incentives to develop and maintain a Culture for Quality Testing in the Laboratory

13 Building a Culture for Quality in the Laboratory Promote Laboratory Management to Strengthen Labs Strengthening Laboratory Management Towards Accreditation (SLMTA) Train Lab Managers on QMS, Service Contract, and Supply Chain Management Promote Accreditation of Laboratory Accreditation is a measure of quality in a laboratory Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA)

14 Building a Culture for Quality in the Laboratory Promote Quality Control Testing Benefits of QC Testing- Identify problems, even before they are an issues Inter-Laboratory Quality Control Program Same Labs testing same QC material Compares accuracy and precision Develop new and innovated QC material and Testing Strategies Strengthen supply chain management and services Promote Quality Assurance Program Development and use of quality assurance program in laboratory QA monitoring program Provide feed back and corrective actions Link to Proficiency Testing Includes monitoring of results and sites

15 Importance of Laboratory Information Systems General Case Study: Prevention of Mother To Child Transmission (PMTCT) of HIV Pregnant mothers are tested for HIV (RT) and tested for CD4 count to provide the appropriate therapy to prevent transmission Many mothers are lost to follow-up due to time or lack CD4 results In some situations, up to 70% of CD4 results never make it to or in a timely fashion to the ANC/RHC for decision for care and treatment Issues to correct- Specimen / Patient referral system Specimen processing lack of standardize identification Reporting of results- lack of systems to get results to clinic

16 Global Labs and Laboratory Information Systems Need for LIS in resource-limited setting Basic need for specimen management and results reporting Standardize and functional Paper-base or electronic Elimination of transcriptional errors Reduce the number of time results to be recorded (manually) Interfacing with Laboratory instruments Put in place a functional laboratory workflow May not need to follow current practices (non-functional or inefficient) Important to map out a functional workflow prior to implementing LIS Provide information on benefits and uses of LIS Importance for acceptance of new system Must provide a benefit to user and laboratory

17 Opportunities for Improved Point-of-Care Testing Worldwide there has been a trend for more point-of-care diagnostics, in areas of infectious disease detection and blood analyte monitoring for patient care. It has been recognized that in order to ensure quality of these pointof-care diagnostic proper quality management and laboratory support is essential for accurate and useful results. There must be a continuous evaluation of the quality of these pointof-care assays to provide valuable input to for the appropriate use for patient care. Plans must promote standards, guidelines and policy for the quality management and monitoring of point-of-care assays, as well for all other laboratory testing.

18 Challenges with Quality Management of POC Testing

19 Elements for Implementation of Quality POC Testing Selection of appropriate assay The assay should be reliable and accurate to provide access to testing and meet the needs of the intended service Standard policy for use An algorithm of testing procedure and interpretation of results must be in place. Linkage of the algorithm to the standard testing Ensure service and supply chain are available Training and competency assessment Needed to identify qualified/certified personnel to perform testing Quality Assurance Program QA monitoring should be done by the personnel performing the test and overseeing QA manager

20 Pima CD4 Point-of-Care Study in Tanzania Pima CD4 testing at Health Care Site Appropriate specimen venous vs fingerstick blood Results compared to standard CD4 testing results Introduction of a Quality Control Testing at the Health Care Site Quality Assurance monitoring program Review of QC results by HCW and National Ref Lab Review of analyzer functional controls by HCW and National Ref Lab Monitoring of results for invalid test rates, errors, and breaks in testing by National Reference Lab

21 Pima CD4 Testing Blood collected Mix Blood: Gentle invert 10x Repeat is necessary Sample ID: Patient ID User ID: Blood apply to Pima cartridge by transfer pipette

22 Pima CD4 Testing (QC) Aliquots of CD4 Count - Mix well - Transfer pipette Sample ID: Lot # User ID: Blood apply to Pima cartridge by transfer pipette

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24 Exporting of Pima Results for Monitoring Facility A Data Warehouse POC Analyzers Black boxes collect store and forward testing data to the server through the GPRS network Queries over GSM/ Internet Web applications built to query black boxes for data collected from lab analyzers Information on quantity of tests done, quality of test and maintenance information collected

25 Example of Pima Exported Results Test ID Device ID Assa y ID Assay Name Sample CD3+CD4+ Value [cells/mm3 ErrorMessa ] ge Operator Result Date Start Time Barcode Expiry DateVolume Device Reagent Software Version 64PIMA-D PIMA-D PIMA CD M 2PIMA CD M Invalid Test Error 850 GEORGE :53:00pass pass pass fail 0.38m Invalid Test Error 810 GEORGE :03:00pass pass pass fail 0.38m 66PIMA-D PIMA CD M 85 GEORGE :15:00pass pass pass pass pass 0.38m 67PIMA-D PIMA CD V 378 GEORGE :35:00pass pass pass pass pass 0.38m 68PIMA-D PIMA CD V 452 GEORGE :53:00pass pass pass pass pass 0.38m 69PIMA-D PIMA CD V 397 GEORGE :13:00pass pass pass pass pass 0.38m 70PIMA-D PIMA CD V Invalid Test Error 810 GEORGE :34:00pass pass pass fail 0.38m 71PIMA-D PIMA CD V 170 GEORGE :47:00pass pass pass pass pass 0.38m PIMA 72PIMA-D BEADS BEADS-NORMAL 838 GEORGE :54:00 73PIMA-D PIMA 3BEADS BEADS-LOW 150 GEORGE :02:00 74PIMA-D PIMA CD4 STRECK-NORMAL 1010 GEORGE :39:00pass pass pass pass pass 0.38m 75PIMA-D PIMA CD4 STRECK-LOW Invalid Test Error 850 GEORGE :01:00pass pass overruled fail 0.38m 76PIMA-D PIMA CD4 STRECK-LOW 169 GEORGE :17:00pass pass overruled pass pass 0.38m 77PIMA-D PIMA CD D 275 GEORGE :32:00pass pass pass pass pass 0.38m 78PIMA-D PIMA CD M 271 GEORGE :52:00pass pass pass pass pass 0.38m 79PIMA-D PIMA CD D 333 GEORGE :19:00pass pass pass pass pass 0.38m 80PIMA-D PIMA CD D 442 GEORGE :48:00pass pass pass pass pass 0.38m 81PIMA-D PIMA CD D 217 GEORGE :13:00pass pass pass pass pass 0.38m 82PIMA-D PIMA CD M 331 GEORGE :34:00pass pass pass pass pass 0.38m

26 Pima Results for QA Monitoring

27 Pima Results for QA Monitoring

28 Pima Results for QA Monitoring

29 Standardization of Use Point-of-Care Testing Supply Chain/Service Policy Training /Competency QA/QC Program Persons Performing Testing Laboratory Monitoring

30 Launch: March 14-16, 2011 Addis Ababa Ethiopia

31 ASLM MISSION To 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.

32 THE DEVELOPMENT AND CREATION OF THE AFRICAN SOCIETY FOR LABORATORY MEDICINE MAPUTO DECLERATION: Call on national governments with support of their donors and partners in resource-limited settings to develop national strategic laboratory plans that integrate laboratory support for the major diseases of public health importance including HIV, tuberculosis, and malaria. 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

33 Commitment for Laboratory Strengthening Governmental and Organizational Support Need to recognize the importance of laboratory for health care Governance in standards of testing, personnel, and policies Supplies and Equipment including service and support Promote Quality testing Laboratory s Role Promote a culture for Quality Personnel recognition for competency Ensure a working environment that is safe and fully functional Advocate for the laboratory in health care system

34 Laboratory Role in Global Health- Conclusion Opportunities to Strengthen Global Laboratories Commitment by all: Government and Agencies Donors and Partners In-country Laboratory services Laboratorian and any Health-care worker performing testing Quality is Important Recognition and Feedback