Health Systems Strengthening: A Focus on Laboratories

Wafaa El-Sadr, MD, MPH

Track 1.0 Meeting Dar Es SalaamAugust 2009

Burden of Disease

2Burden of Disease 2004, WHO

Leading Causes of Burden of Disease (DALYs in millions)

GLOBAL BURDEN OF DISEASE

Global Burden of Disease, WHO

“Collecting, pooling, and purchasing” Expanding financial resources for health Pre-paid risk pooling (e.g., mutuelles) Performance-based financing

Both HIV prevention and HIV treatment are chronic endeavors

5

Characteristics of HIV Disease Requirements

Impact throughout lifecycle Services for adults (including pregnant women), infants, children, adolescents

Asymptomatic periods, acute episodes of illness, chronic symptoms

Health maintenance, continuity care, linkages

Multiplicity of clinical & psychosocial needs

Multidisciplinary teams, referral systems & partnerships

Importance of adherence & retention Relationship between patients & providers, outreach & tracking

Need for clinical & laboratory monitoring, medications & other commodities

Infrastructure, medical records/registers, laboratories, procurement systems

Transmissible infection Counseling, antenatal care, family planning and prevention methods

Health Systems in Crisis

ICAP In

Africa

Nu

mb

er

of s

ites 839

471 458

266

627

330 331 339

0

100

200

300

400

500

600

700

800

900

Number of ICAP-supported sites by activity, March 2009 (n=839)

Proportion of ICAP-supported HIV care and treatment sites with access to laboratory assays

(n=342)

% s

ites

35%48% 45%

32%

4% 6%

60%47% 48%

58%

78%

32%

0%

50%

100%

CD4 count Blood Chemistry

LFT CD4 percent Infant Diagnosis /

PCR

HIV-RNA

Available On-Site Available Off-Site

Proportion of ICAP-supported HIV sites with access to laboratory assays (n=336)

1 assay; 2%

2 assays; 1%

3 assays; 3%

4 assays; 13%

5 assays; 52%

6 assays; 29%

Approach to Lab Support

• Network approach– Standardized infrastructure and assays– Linkages: specimen transportation system– Capacity

• Number and skills of staff• Training and Mentorship (laboratory & management)

• Integrate lab and clinical activities• Strategic Planning

Laboratory Network

Tiered Laboratory NetworkDeveloping the lab network:

• define the number/level of labs in network– Based on # patients and geography of area

• define a standard minimum package for each tier:– Infrastructure and equipment– Testing menu for each level– Staffing– Training– SOPs, manuals and forms– Reagent/supply lists– Data management systems– QA/QC systems

• Lab support in not just about buying machines!

Infrastructure Enhancement

 

Standardized Renovations • water and power supply• work surface materials • illumination of workspace• equipment• biosafety

Test Reference Lab Provincial District Health Center

HIV Serology EIA, Rapid Tests, WB EIA, Rapid Tests, WB EIA & Rapid Tests Rapid Tests

CD4 cell count FACSCalibur FACSCount FACSCount or Ref to

Provincial Lab Ref to District Lab

PCR /DBS for Infant Dx Roche DNA PCR Refer to Ref Lab Refer to Ref Lab Refer to Ref Lab

Viral Load Roche RNA PCR Refer to Ref Lab Refer to Ref Lab Refer to Ref Lab

Resistance Testing

Selected sites/Referral Refer to Ref Lab Refer to Ref Lab Refer to Ref Lab

Chemistry

Integra 400Abbott c8000

Ortho-Clinical Vitros DT 60II; Visual BioMerioux

Abbott c8000Ortho-Clinical Vitros

DT 60II; Visual BioMerioux Roche Reflotron Roche Reflotron

Hematology B. Coulter 5 diff B. Coulter 5 diff ;

Sysmex K-21 (3 Diff) QBC Machine QBC Machine

TB Microscopy & Culture Microscopy Microscopy Microscopy

Syphilis TPHA, RPR TPHA, RPR, TPHA & RPR RPR

OI Diagnosis

Microscopy , Serology, culture, and

PCRMicroscopy &

Serology Microscopy & Serology Microscopy

Parasitology Microscopy, Malaria

smear Microscopy, Malaria

smearMicroscopy, Malaria

smearMicroscopy, Malaria

smear

Urinalysis Test Strip and Reader Strip and Reader Test Strip Test Strip

ICAP Lab Network: Standardized package by tier

(Equipment listings should be considered as brand name equivalents and broadly representative of model, grade, and complexity.)

Goals of Clinical Systems Mentorship

–Effective program implementation–High quality care–Sense of local ownership–Sustainability

http://www.columbia-icap.org/

Goals of LSM

• Improve the quality of test results

• Build local capacity of lab systems

• Establish local ownership

• Integrate lab as part of clinical services

Numerator Evaluation of Program Quality

Result of Quarterly measure of SOC ICAP Standards of Care (SOC)

for Lab Services Suggested

Measure of SOC Denominator

Possible Source of information

Possible Actions

# of patients tested for HIV that receive their results

during the same visit <75% 75-89 % >90 %

1

All patients who request HIV testing should receive their test results during the same visit

% of patients tested and receiving results during the same visit

# of patients tested for HIV

VCT register; PMTCT register, TB/HIV register Evaluate this

month

Prioritize and evaluate next

quarter On target

# of CD4 test results written in

clinical chart within one

month after the test was

ordered

# of CD4 tests

conducted at laboratory within one

month after the test was

ordered

<75% 75-89 % >90 %

2

CD4 test results should be received at the treatment facility within one month after the test was ordered

% of CD4 test results written in clinical chart within one month after the test was ordered

% of CD4 tests conducted at laboratory within one month after the test was ordered

# of CD4 tests

ordered

# CD4 tests ordered

PMTCT register, Care and Treatment Register, Lab log books

Evaluate this month

Prioritize and evaluate next

quarter On target

# of TB smear results

written in clinical chart

within 7 calendar

days after the smear

was ordered

# of TB smear results

conducted by the

laboratory within 7 calendar

days after the smear

was ordered

<75% 75-89 % >90 %

3

TB smear results should be received by the patient within 7 calendar days after the smear was ordered

% of TB smear results written in clinical chart within 7 calendar days after the smear was ordered

# of TB smear tests

ordered

# of TB smear tests

ordered

TB register, Care &Treatment Register

Evaluate this month

Prioritize and evaluate next

quarter On target

ICAP Lab indicator SOC

Shyira District Hospital, Rwanda SOC: All HIV-positive pregnant women should have CD4 testing done

within first month of diagnosis

Laboratories:Serving Clinical Services

• Where is blood drawn?• Where are assays done?• How to transport specimens?• How to transmit results?• How to use results?

Where the test is done?ICAP-Ethiopia

Conclusions• Enhancing laboratories is a clear contribution

to health systems strengthening• Laboratory support needs to conceptualize

labs as part of the clinical services• Laboratory support needs to also focus on

durable effective systems responsive to patient needs

• Strong laboratory systems are critical to effective response to broad array of health threats

Ver

tical

Fun

ding

Horizontal Implementation

AcknowledgementsICAP-NY Team• Jessica Justman• ICAP Lab Teamt

– Amilcar Tanuri, Senior Regional Lab Advisor

– Luis Felipe Gonzalaz, Regional Lab Advisor

– Stephania Koblavi-Deme, Regional Lab Advisor

– Allison Goldberg, ICAP-NY, GRA – Charon Gwynn, M&E Liaison for

Lab Support

ICAP in-country Lab Advisors– Rwanda

• Alaine Nyaruhirira– Cote D’Ivoire

• Dje Kouakou– Ethiopia

• Bereket Hailegiorgis– Kenya

• Kevin Omondi– South Africa

• Thabo Taleng – Tanzania

• Pierre Rugimbanya– Nigeria

• Juliet Iseniyi– Mozambique TBN