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THOMAS GACHUKI National Public Health Laboratory Services

IMPLEMENTATION OF ISO 15189 STANDARDS FOR IMPROVEMENT IN QUALITY OF HIV VIRAL LOAD AND EID SERVICES IN KENYA. THOMAS GACHUKI National Public Health Laboratory Services (National HIV Reference laboratory : NHRL ) Kenya . NPHLS-NHRL KENYA . Presentation outline . Background Issues

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THOMAS GACHUKI National Public Health Laboratory Services

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  1. IMPLEMENTATION OF ISO 15189 STANDARDS FOR IMPROVEMENT IN QUALITY OF HIV VIRAL LOAD AND EID SERVICES IN KENYA THOMAS GACHUKI National Public Health Laboratory Services (National HIV Reference laboratory :NHRL) Kenya NPHLS-NHRL KENYA

  2. Presentation outline • Background • Issues • Overview of NHRL • Situation before QMS • Quality improvements • Outcomes • Impact • Next steps • Conclusion

  3. Background • HIV is a public health problem in sub Sahara Africa including Kenya • Effective HIV treatment is a recognized approach for prevention of disease spread Increased viral levels predispose one to opportunistic infections • In babies early diagnosis and treatment are key determinants of transmission prevention • The laboratory is vital for these clinical outcomes

  4. Background • HIV DNA PCR test indicated for diagnosis in infants • HIV RNA PCR test used for assessing HIV viral load • Quality requirements needed for these tests: • Accuracy of diagnostic DNA PCR test • Precision of HIV RNA PCR viral load for efficacy assessment and detection of resistance • Clinically useful TAT for both tests to aid in management decisions

  5. Issues • PCR based assays • highly sensitive making them prone to pre-analytical contamination leads to errors • therefore require stringent quality measures • Public laboratories in sub-Sahara Africaare characterized by poor infrastructure and no laboratory quality management systems(QMS) NPHLS-NHRL KENYA

  6. NHRL Overview • Established in 2003 • Serves as Kenya’s public referral HIV laboratory offering viral load testing and early infant diagnosis

  7. NHRL Overview • Performing average 10,000vl per year • Serves patients over 500km radius • One of 6 public labs offering these services NPHLS-NHRL KENYA

  8. Situation before QMS • Pre- analytical- poor sample quality • Analytical –many runs lost, unreliable , inefficiencies, lacked standardization ,quality monitoring not done • Post analytical- delays, unsatisfied customers Therefore the need to establish a QMS

  9. WHO-AFRO SLIPTA process used Baseline Audit 45% Mid term Audit 95% Improvement Projects Improvement Projects Improvement Projects Behavioral Changes & Laboratory Improvement Workshop #1 2010 Workshop #2 2011 Workshop #3 2011 (3 months) (3 months) (3 months) Site Visits Site Visits Site Visits 2013 ISO ACCREDITATION

  10. Quality Improvements Monitoring quality indicators: • Turn-around time • Specimen rejection rates • Service interruptions • Customer satisfaction • EQA performance Trainings done: • ISO sensitization • Good Laboratory Practice • Biosafety • Internal auditing • Skill based training in accredited labs NPHLS-NHRL KENYA

  11. Quality Improvements Post analytical: • Use of LIMS – direct email of results • Customer contracts • Trained users on standardized reporting form Pre- analytical: • Client handbook • Training on specimen collection • Cold chain maintenance NPHLS-NHRL KENYA

  12. Analytical phase improvements Environment and Facilities • Access control • Separation of rooms • Environmental control Equipment management: • Validation • Preventive maintenance • Service contracts • Capital Equipment procurement plan Personnel • competency assessments and retraining • Ethical practice (Confidentiality) Process control: • IQC • EQA Inventory management

  13. Outcomes Pre-analytical • Improved sample quality • Reduction in specimen rejections Post analytical • Increased Customer confidence • Regular communication with customers

  14. Outcomes – Analytical phase • Elimination of reagent stock outs. • Elimination of analytical service interruptions(15 to 0 days) • Reduced analytical variations and improved results quality • Contamination eliminated • Standardization of all the processes Economic benefits: • Reduced reagent wastage • Reduced analytical runs repeats • Reduced equipment breakdowns

  15. Impact Increased uptake of services 68% Turn-around times reduced from 30 to 6 days

  16. Drivers for success • Leadership • Staff commitment • Effective mentorship, • Training • Funding

  17. Next steps Internal: • Service expansion to meet need of over 60,000 EID analysis annually • Introduction of HIV drug resistance testing Outreach: • Mentoring regional public labs offering viral load testing services

  18. Conclusion • Implementation of ISO 15189 has led to major improvement in both analytical and service quality dimensions for HIV viral load and EID services in Kenya • This is possible even for a public laboratory • In 2013 NHRL became the first public health laboratory in Kenya to attain ISO 15189 accreditation 18

  19. ASANTE SANA

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