1. CDC and support for Point of Care Testing Accreditation Muthoni Junghae CDC-Kenya LAUNCH OFF POINT OF CARE TESTING ACCREDITATION PROGRAM PANAFRIC HOTEL-18TH AUGUST 2016 Center for Global Health Place Descriptor Here

2. Point of Care Testing  “testing that is performed near or at the site of the patient with the result leading to possible change in the care of the patient.” ISO definition Outpatient clinics Hospital units Satellite facilities Doctor’s clinics Non-lab personnel - such as nurses and paramedical personnel POCT

3. Access to diagnostic services  Exponential increase in the number of POC tests conducted and sites for testing  POCTs -fastest growing segment in diagnostics  increasing by 10% annually  generating about 25% of total lab revenue.  Approx 31,000 POCT equipment in use world-wide  In use in Kenya HIV, Haemoglobin, Glucose, Pregnancy, Strep A, Creatinine, Urinalysis (including analysers), Syphilis,, mTB testing and CD4. in the pipeline- viral load and early infant diagnosis.

4. Advantages of using POCTs  improved access to laboratory tests to support diagnosis and treatment,  improved efficiency of care in certain settings,  improved patient compliance,  reduced LTFU,  Improved turnaround time,  less space than traditional laboratory methods  reduces the need for costly, logistically difficult specimen transport to a laboratory  smaller sample volumes, improved patient and clinician satisfaction

5. Challenges of using POCT  difficulties with quality control/documentation,  higher unit of cost/reagent  greater personnel requirements at clinic  longer patient wait times  poor regulatory control  misuse and erroneous results.

6. Gaps in POCT  Lack of standardization of staff training  Lack of standardized lab procedures,  Lack of adherence to good laboratory practice,  patient identification procedures  POCT not included into laboratory QMS and regulations.

7. Ongoing efforts around POCT Evaluation/validation or verification of appropriateness of POC technologies for country needs as a regulatory requirement for registrati  Evaluation/validation /verification of POCT as a registration requirement  Sets criteria for assessment of healthcare needs and determining appropriateness for deployment of POCT,  Training, competency assessment and certification of HCW before using POCT for testing patient  Mandatory requirements within quality management in compliance of ISO 22870 for POCT

8. WHO Handbook on improving the quality of HIV-related POCT purpose: to emphasize the importance of quality assurance and quality improvement for POCT to strengthen existing quality assurance and quality improvement practices for POCT to highlight the need for a cadre of quality officers and a network of POCT testers; to provide new innovative quality assurance and quality improvement strategies; to share a comprehensive package of established and new quality assurance and quality improvement tools for POCT.

9. Framework for National Certification Program for HIV And Other Point Of Care Testing Ensuring the Reliability and Accuracy of Point of Care Test Results IMPLEMENTING THE WHO HANDBOOK ON IMPROVING THE QUALITY OF HIV RELATED POCT provide possible approaches to achieve national certification of testing sites & testing providers strengthen existing testing site & provider certification practices; highlight the importance of leveraging existing resources to achieve certification and related quality improvement targets; share best practices and tools in the areas of testing site and provider certification program development

10. Rapid Testing Qualitty Improvement Initiative -RTQII Levels% Score Level 0 = Less than 40% (immediate remediation) Level 1 =40% - 59% (needs improvement in specific areas) Level 2 = 60% - 79% (partially eligible) Level 3 = 80% - 89% (close to site certification) Level 4 =90% or higher (Eligible for certification)

11. POCT Accreditation  CLSI- a global leader in areas of standards and guidelines for laboratory testing  CDC Kenya - Clinical Laboratory Standards Institute (CLSI) partnerships since 2015  support KENAS in the development of required capacity to establish and monitor POCT standards.  These developments will address QMS needs including  training,  competency assessment,  compliance with regulatory needs  auditing by trained auditors

12. CLSI support to KENAS  So far..  KENAS assessors trained on ISO 22870 standards  Guidance documents for ISO 22870 developed  Ongoing support…  ensure availability of feasible, affordable and accessible quality assured POCT to support  ensure that POCT facilities apply ISO 22870 and ISO 15189 standards for both quality management system and competency.

13. Congratulations KENAS !!!