1. LABORATORY QUALITY MANAGEMENT AS A KEY COMPONENT OF PATIENT MONITORING: THE NYUMBANI DIAGNOSTIC LABORATORY EXPERIENCE Annie P, Susan W, Tresa P, Lihana R, Rachel M, Mary O. Nyumbani Diagnostic Laboratory, Nairobi

2. NYUMBANICHILDREN'S HOME Founded in 1992 by the late Fr. Angelo D'Agostino, SJ, as an active response to the number of HIV infected children who are orphaned or abandoned in Kenya.

3. BACKGROUND: NYUMBANI DIAGNOSTIC LABORATORY The laboratory was established in 1998. – Need of quality testing services for its children – Viral load/CD4 monitoring The laboratory has over 15 years of service delivery. The laboratory is a state-of-the-art facility situated along Karen Dagoreti road in Nairobi

4. MANAGEMENT SYSTEMS A quality management system can be defined as coordinated activities to direct and control an organization with regard to quality. Quality management system addresses all processes – The environment – Quality control procedures – Communications – Record keeping – Competent and knowledgeable staff – Good-quality reagents and equipment

5. THE QUALITY MANAGEMENT SYSTEM Stock/Inventory Documents and Records Process improvement Process control Occurrence Management Customer Service Information Management Assessment Facilities and Safety OrganizationPersonnel Equipment Organized based on the 12 Quality System Essentials.

6. LABORATORY MANAGEMENT In any laboratory, the management system encompasses all processes and procedures that are geared towards ensuring quality. Laboratory quality can be defined as accuracy, reliability and timeliness of reported test results. Based on this, ISO standards have grouped laboratory processes into categories: – Pre-examination, – Examination – Post-examination

7. OBJECTIVES OF LAB QUALITY To improve results: – accuracy, – reliability Minimize turnaround time Avoid unnecessary treatment Reduce treatment complications Failure to provide the proper treatment Remove delays in correct diagnosis Avoid additional and unnecessary diagnostic testing. Improve the quality of health care

8. METHODOLOGY Nyumbani diagnostic laboratory has endeavored to develop an elaborate management system for quality laboratory output. This has been through: – directional workflow (Laboratory techniques ) including Sampling, Testing Results transmission.

9. METHODOLOGY: WORKFLOW Patient These are identified by clinicians in various hospitals/clinics Walk-in clients Test selection Depending on need for a test to inform patient care Sample /Transport If in Laboratory: Trained Phlebotomist is at hand to collect/draw sample If drawn in the field(outside NDL), this is put on courier to the laboratory lab analysis This occurs on automated platforms report creation Automatically generated, checked, verified by qualified staff report transmission This is through electronic transfer to recipient facility/Clinician with hard copies mailed back to the facility (by courier)

10. METHODOLOGY Elaborate SOPs in: Virology Viral Load: Abbott PCR Machines Sequencer: ABI3100

11. METHODOLOGY Elaborate SOPs and working instructions in: Microbiology (TB; GenExpert) Capacity to diagnose and determine MDR TB

12. METHODOLOGY Elaborate SOPs and working instructions have been reviewed in: Biochemistry Automated COBAS Machine

13. METHODOLOGY Elaborate SOPs and working instructions have been reviewed in: Immunology Hematology FACS Calibur Haemogram Machine

14. TRANSMISSION OF RESULTS Results checked by individual laboratory staff after testing Results counterchecked, verified and signed Results signed by Director and released/ Transmitted to client Results verified 3 times before release to client Client

15. OUTCOMES Automated systems for testing. Over 100, 000 samples processed – high level quality and accuracy of up to 99.9%. Staff safety has been enhanced – safe environment for diagnostics. The laboratory has attained ISO 15189 accreditation. The turnaround time has been reduced by 60%. The laboratory provides appropriate testing to over 3,500 clients. – Private and public hospitals – Nyumbani – Lea Toto – Kitui Village 1.Multi-National Health Non-Governmental Organizations 2.Research Institutions 3.General Medical Institutions Fraternity 4.Leading Health Care Specialists Clinics 5. Major Laboratories 6. Private Companies 7. Community Based Health Care Programmes 8. Walk-in Clients 9.Insurance Agencies

16. OUTCOMES Automated systems for testing. Over 98% of HIV infected individuals receiving NDL services have attained undetectable viral loads. Reduced complications associated with drug resistance.

17. OUTCOMES NDL pioneered DRT for diagnosis in Kenya (2010) Drug resistance testing ensures timely regimen change Turn around time – Depending on number of samples 2 weeks – regular samples delivery DRUG RESISTANCE TESTING

18. CONCLUSION  Nyumbani laboratory has endevoured and continues to seek:  better disease diagnosis  provide proper treatment  reduce complications and unnecessary diagnostic testing.  Through this monitoring, treatment has been boosted.  With its vision of improving health care in Kenya, the Nyumbani laboratory management and staff remain at the forefront of attaining quality for all.

19. THANK YOU Call Nyumbani Laboratory: 0722 539 294 0739 364 429 Email: diagnosis@nyumbani.org Website: www.nyumbanilab.co.ke www.nyumbani.org