Quality Assurance of TB Programs in Low Resource Countries

1
Quality Assurance of TB Programs in Low Resource
Countries

• Richard Laing
• Kayla Laserson
• TLC Course

2
Elements of Quality Assurance

• Structure
• What must be in place in terms of people,
  buildings, and organization for an efficient
  system?
• Process
• What must occur to utilize the people, buildings,
  and organization efficiently?
• Outcomes
• What is the expected outcome of these activities?

3
Components of DOTS

• Government commitment to TB control
• Passive diagnosis by smear microscopy
• Observed administration of free, standard,
  short-course chemotherapy (SCC)
• Continuous and reliable drug supply
• Efficient recording and reporting system

4
Government Commitment to TB Control

• Creation of a national TB program
• Political and financial support
• Production of TB Manual
• Integrated with the primary health care system
• Commitment to provision of
• Technical leadership
• Drugs free of charge
• Diagnostic materials
• Regulation of TB drugs

5
Passive Diagnosis by Smear Microscopy

• Case-finding
• Focus on patients attending general health
  facilities
• Diagnosis
• Bacteriologic confirmation based primarily on
  microscopy (culture when available) rather than
  x-ray
• Sputum microscopy highly specific
• Smear correlates with severity of disease and
  infectiousness
• Inexpensive

6
SCC with Directly Observed Treatment

• Abbreviated DOT, not DOTS
• Use of a standard regimen for 6 months
• Efficacy of short-course regimen demonstrated in
  controlled clinical trials
• Standardized regimens are safe and effective
• DOT for at least first 2 months, preferably all 6

7
Directly Observed Treatment

• One of the most difficult and controversial
  aspects of the DOTS strategy
• DOT ensures adequate treatment
• With the right drugs
• In the right doses
• At the right intervals

8
Directly Observed Treatment

• Treatment observer must be accessible and
  acceptable to the patient and accountable to the
  health system
• Observation is a service to patients and
  providers
• Studies have demonstrated that 30 of patients
  do not take medicines regularly
• Impossible to predict which patient will take
  medicine

9
Observation Models

• General health care service delivery
• Community volunteerism
• Religious community
• Community health care delivery such as child
  survival workers and lay midwives
• Non-governmental organizations

10
Regular, Uninterrupted Supply of Drugs

• Each patient must be ensured the entire course of
  prescribed treatment, without interruption
• Drugs must be of good quality, with adequate
  bioavailability
• Use of fixed-dose-combination drugs (FDCs)

11
Efficient Recording and Reporting System

• Laboratory Register records every sputum from
  every patient
• TB Register records the case management and
  treatment outcomes of every TB case
• Maintained system of quarterly reporting and
  analysis of cohorts of patients
• Facilitates operational research to improve
  program effectiveness

12
DOTS Indicators?

• Measures of government commitment
• Organizational and budgetary decisions
• Proportion of population with access to DOTS
• Smear-positive cases should be 45 of all
  notified cases and 65 of all pulmonary cases
• 2- or 3-month sputum smear conversion rate
• Case notification rate gt 70 (denominator??)
  consider delay analysis
• Adherence gt85
• Cure of new smear-positive patients gt 85 (effect
  of HIV ?)

13
Conclusion

• Structures must be in place as a basis for a
  quality program
• Supervision focuses on process
• Outcomes depend upon adequate structures and
  efficient processes
• The effective manager focuses on quality
  assurance!!