This document summarizes Barbara Chase McKinney's capstone project assessing laboratory services in Lesotho and developing a quality assurance program. It provides context on Lesotho's healthcare system and the increased demands on laboratories from scaling up ART. McKinney conducted assessments of various laboratories, finding issues with infrastructure, equipment, supplies and human capacity. Her quality assurance plan addressed quick fixes, essential elements and long term goals - including training, establishing quality standards, and working towards national accreditation. Progress included forming a national quality team and developing a quality manual.

1. Laboratory Services in Lesotho:
A Journey to Quality
Capstone Project Presentation
Barbara Chase McKinney,M.D.
May 1, 2007

2. Acknowledgements
 American Society for Clinical Pathology (ASCP)
 Ministry of Health and Social Work / Laboratory
Services, Lesotho
 World Health Organization (WHO)
 The Centers for Disease Control (CDC)
 The Clinton Foundation
 Johns Hopkins Bloomberg School of Public
Health
 Gilbert Burnham, MD, PhD

3. Today’s Journey
 Context
 The Country and the Healthcare System
 MOHSW / Laboratory Services
 My Assignment
 Assessment
 Findings
 Quality Assurance Program Plan
 Training
 Progress

5. Lesotho at a glance
 Independent Kingdom
 Completely surrounded by South Africa
 Area – 30,355 sq km (slightly smaller than Maryland)
 Population: 2,022,331
 HIV/AIDS Prevalence Rate: 28.9%
 PLWHA: 500,000 including 16,000 children

6. Lesotho Healthcare System
Health Service Areas

7. Laboratory Services in Lesotho
 GoL Initiates Large Scale
ART (2004)
 Laboratories essential to
diagnosing HIV and monitoring
ART
 Increased testing volume
(>200%)
 Expanded range of services
offered
 New high technology equipment
 Added demands for highly
accurate and reliable results
 “Know your Status”
Campaign (2005)

8. ART Scale Up

9. My Assignment
Technical Assistance to the MOHSW / Laboratory
Services of Lesotho
Quality Assurance Program

10. Letter from MOHSW
Laboratory Director
“We are in the process
of setting up our
quality assurance
programme and
basically we will be
starting from
scratch…”
Kekeletso Mosisili

11. My Trips to Lesotho
June 20 to July 7, 2006
September 18 to October 6, 2006

12. Today’s Journey
 Context
 My Assignment
 Assessment
 Assessment tools
 Laboratories Assessed
 Findings
 Quality Assurance Program Plan
 Training
 Progress

13. Assessment Tools
 Direct Observation
 Questionnaire
 Interviews - Stakeholder Analysis
 Laboratory Personnel
 Laboratory Clients – Patients, Physicians, Nurses, Hospital Administrators
 Laboratory Stakeholders
 Donors/Funding Agencies
 Governmental
 Non-governmental
 Documents
 Job Descriptions
 Laboratory Statistics
 Lesotho National HIV/AIDS Strategic Plan, 2006-2011
 MOHSW Summary Operational Plan 2005/2006
 MOHSW Memorandum of Understanding with Health Partners

14. Laboratories Assessed
 June / July 2006
 Butha-Buthe
 Leribe
 Mafeteng
 Mahale’s Hoek
 Queen Elizabeth II
 Scott Hospital *
 September / October 2006
 Maluti Adventist Hospital*
 Berea
 Mantsonyane – St. James *
 Roma – St. Joseph’s *
 Qacha’s Nek – Maatebeng
Hospital
 Tebellong Hospital *
* CHAL Hospitals

15. Facilities

16. Findings
 Infrastructure
 Facilities
 Space
 Safety
 Equipment
 Consumables -
 Reagents
 Purchasing & Inventory
 Human Capacity
 Culture of Quality

17. Today’s Journey
 Context
 My Assignment
 Assessment
 Findings
 Quality Assurance Program Plan
 Training
 Progress

18. What is to be done?
 Quick Fixes
 Must Be Done
 For the Long Term

19. Quick Fixes
Culture of Quality
 Quality Champion from
each lab to form a
national Quality Team
 Principles of quality to all
laboratorians – QA
Seminar
 QA newsletter
 Equipment monitoring
initiated
 Hand washing

20. Quick Fixes
Environment
 Inventory all
equipment and
remove all non-
functioning
equipment from the
laboratory premises
 “House Cleaning”
 Remove old
paperwork, manuals,
and receipts

21. Quick Fixes
Recognition
 Make it rewarding!
 Develop a laboratory
recognition program
 Criteria for excellence
 Plaque
 Recognition ceremony
 Presented by
prominent official
 Publish it in the
newspaper

22. Must Be Done
Culture of Quality
 Daily QC
 Internal & External Controls
 Standard Operating Procedures (SOPs) for all
procedures performed
 Documentation & Record keeping
 Statistics tallied, recorded, and reported monthly
 Equipment
 Maintenance logs
 Temperature monitoring for all refrigerators and blood bank
transport

23. Must Be Done
Culture of Quality
 Improvement must be
measured
 Balanced scorecard for
each lab or section
 Compare divisions
graphically
 Post graphs in each
laboratory
 Publish the results in the
QA newsletter
0
10
20
30
40
50
60
70
80
90
Jul Aug Sep Oct
Heme
Chem
Micro

24. For the Long Term
Equipment
 Basic equipment in
every lab
 Equipment logs
 Maintenance & routine
service (Service
contracts purchased
with equipment)
 Repair -
communication with
service personnel
 Safety policies &
protocols

25. For the Long Term
Consumables
 Assure reliable
reagent supply
 Budgeting
 Inventory Control
 Consider strategies to
make the laboratory
sustainable
 Consider cost
recovery

26. For the Long Term
Human Capacity
 People are an investment in
the future
 Establish a culture of quality
 Training for all laboratorians
 Test-specific
 Management
 Organizational structure of
responsibility and authority
 Career advancement
 Competency assessment
 Hire clerks

28. Today’s Journey
 Context
 My Assignment
 Assessment
 Findings
 Quality Assurance Program Plan
 Training
 Progress

29. Quality Assurance Seminar
October 1, 2006 - Lancer’s Inn Maseru
Seminar Topics
1. Principles of Quality
Assurance
2. Specimen
Management
3. Internal & External
Quality Control
4. Standard Operating
Procedures
5. Documentation and
Record Keeping

30. Seminar Statistics
 39 Attendees of 40 Invitees
 Educational Evaluation
 38 total pretests, 24 matched pre and post tests statistically evaluated
 Matched Pre-test Score Mean – 17.5
 (Confidence Interval 16.53-18.47)
 Matched Post-test Score Mean – 19.1
 (Confidence Interval 18.31-19.94)
 Paired t-test t = .003, p >0.2
 Change in Individual Scores – All individuals showed improvement
 Satisfaction Evaluation
 Overall meeting rated 3.87 out of 4.0 by participants
 Based on 21 point assessment
 Planned 3 month follow-up
 Internal Assessment with Checklist

31. Training
 MOHSW Laboratory Training Plan (CHAI)
 Pre-service
 ASCP Evaluation of NHTC
 Lesotho, November 2006
 Test-specific technical training
 ASCP Chemistry, Hematology & CD4
 Lesotho, July 2007
 Clinic-laboratory relations
 Laboratory Management Training
 ASCP Module Development
 Chicago, March 2007
 Mentoring Program

32. Progress
 Infrastructure
 Reagents & Consumables
 Human Capacity
 Culture of Quality

33. Culture of Quality
 QA Representatives forming a National QA Team
 QA Newsletter
 Quality Manual
 Mission, Vision & Values
 Quality Standards
 National Quality Management System
 Standard Operating Procedures
 Laboratory Handbook for Users
 National Accreditation
 EQA / Proficiency testing for the laboratories
 EQA for Rapid HIV Testing
 New position for managing EQA for rapid testing

34. The Journey Continues…
June 4-20, 2007

35. Discussion