WHO AMDS Partners and Stakeholders Meeting, GenevaApril 2-3, 2009

Strategies for Strengthening Laboratory Supply Chains

Carmit Keddem, Technical AdvisorUSAID | DELIVER PROJECT

Overview

• Importance of laboratory logistics systems• Assessment of laboratory systems • Design and implementation of laboratory

logistics systems• Standardization of laboratory equipment and

supplies

Importance of Laboratory Logistics Systems• Public health programs depend on laboratory

testing for:• Screening• Diagnosis• Patient management • Disease surveillance

• Without supplies, labs cannot perform tests, compromising provision of vital services

• Many tests require simultaneous availability of multiple commodities

Logistics Cycle

Activities to Strengthen Laboratory Supply Chains

Assessment

QuantificationReview

and update

System Implementation

Use DataFor

Decision-Making

Standardization

Quantification

System Design

Purpose of Laboratory System Assessments

• To understand the current state of laboratory services, capacity, and logistics

• To identify and prioritize supply chain interventions within the context of lab management practices

• To provide baseline for evaluation and ongoing monitoring & evaluation

The Assessment Tool for Laboratory Services (ATLAS):• Comprehensive tool to review

all aspects of lab services:– management practices– testing capabilities– logistics system & commodity availability

• Both diagnostic and M&E tool• Customized for each country• Can be used in combination

with other tools

Country Case Study: Malawi Laboratory Assessment• Quantitative and Qualitative Components

– Central-level policy workshop – 40 total sites visited, representing labs at all levels (2

Central Hospitals, 13 District Hospitals, 25 Health Centers)

• (Illustrative) Findings– No standard equipment list in place – Stock levels of lab products are not monitored

systematically – Service disruptions due to stock out of lab supplies – No logistics data used for quantification and

procurement planning

Purpose of Designing and Implementing a Laboratory Logistics System

To obtain and movelaboratory commodities in a timely fashion to the places where they are needed at a reasonable cost.

Building Blocks in Designing a Laboratory Logistics System• A logistics management

information system• An inventory control system• Distribution systems• Storage mechanisms• Monitoring and supervision

systems• A pipeline diagram of the

supply chain Example: Pipeline Diagram from Zambia

Designing a Laboratory Logistics System for HIV, TB & Malaria Commodities in Ghana

• Participants:– PHRL and lab staff from all levels; program

managers; CMS/RMS; partner and donor organizations

• 1-week participatory design workshop format:– Capacity building (logistics concepts and terms)– Review of assessment results– Participants designed system elements in small

working groups (LMIS, ICS, Storage/Distribution)– Large group discussion to harmonize final system

Design Considerations and RecommendationsProduct Considerations Design Recommendation

Shelf life for laboratory commodities ranges from 3- 24 months

Design length of the pipeline to accommodate shelf-life of most products; Products with less than 3 months shelf-life go through separate supply chain.

Laboratory commodities are bulky If storage is limited, choose ICS requiring lower stock levels; Accommodate additional trucks in distribution schedule.

Exact consumption for liquid/powder reagents difficult to measure and track

Use issues from the store room as a proxy for consumption.

Logistics and LMIS forms relatively new concept to lab personnel

Involve stakeholders from all levels and programs from design; Pilot the design prototype first to build confidence in the system

The Design and Implementation Process and Timeline

…In one country the design and

implementation process is projected

to take 24 months; the process can range from12-24 months, depending on the country context.

PEPFARImplementing Partner

Laboratory Standardization

• Prerequisite for optimizing laboratory supply chains

• Precedes laboratory system design and implementation and quantification

PEPFARImplementing Partner

Opportunities for Standardization

• Greater global attention and funding of laboratory supplies and supply chains strengthening

• Maputo meeting (January 2008) made recommendations on laboratory testing and standardization

• Global consensus and focus on the importance of standardization

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What is Standardization?

• Standardization is the process of setting:- Test menus, - Test techniques, - Laboratory equipment, and - Operating procedures.

…for each type of test at each level of the system

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Practical Example of Standardization

Step 1: Develop a list of test menu by level•HC: HIV Rapid Test, RDT, Pregnancy Test, Hemoglobin, CD4•District : HIV Rapid Test, RDT, Pregnancy Test, Hemoglobin, CD4, Viral Load, AST/ALT

Step 2: Define techniques and equipment for each test; select according to certain criteria

Western District

East District

Northern district

Southern district

Central district

CyflowSL3

Guava

District Hospital

FACS Calibur

Sysmex kx21 Cyflowcounter

FACS Count

Health Center

refer samples to district-level laboratory

Coulter-manual

FACS Count POOCH

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Desired Outcome of Standardization

• To streamline list of tests, techniques and equipment by level

…. and therefore the total number of products required. For example:

• Kenya: 3,000 300• Botswana: 800+ 500

PEPFARImplementing Partner

Country Experiences

• Kenya, Uganda (2004, 2005)• Initial request for logistics system design and

quantification of laboratory supplies• Standardization identified as a

pre-requisite for both activities

• Ghana, Ethiopia (2007)• Standardized equipment in place at

time of logistics system design

• Zambia , Botswana (2007, 2009)• As in Kenya, Uganda, standardization identified

as pre-requisite for logistics system design and quantification

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Steps in Standardization

1. Assess existing test menus, techniques, standard operating procedures and equipment at facilities from all levels

2. Hold consensus building workshop with stakeholders from all levels

3. Update laboratory policy documents with new standards

4. Determine timeframe for reviewing and updating standards

5. Disseminate and implement standards at all facilities and levels

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Benefits of Standardization

• Rational decision making in product selection, forecasting, quantification and procurement

• Manageable supply chain by streamlining the number of laboratory products

• Affordability through economies of scale• Agile supply chain allowing redistribution of

supplies to reduce stock imbalances• Efficiency in training and management of staff• Quality assurance of testing by increasing

reliability and consistency of results

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Challenges in Standardization

• Rapidly changing technology• Involving and reaching consensus among

all stakeholders• Allocating time and resources to implement

transition plan• Changing provider behavior to comply with

new standards• Compliance with existing long term

contracts with suppliers

PEPFARImplementing Partner

Standardization Process in Botswana

Process to Date:Assessment (2007) and Quantification (2008)

Identify need for standardizationStandardization Workshop (2009) precedes

logistics system design process

Next Steps:Committee working to revise current policy on

procurement of standardized equipmentFinalize and get agreement on the list of test

menus, techniques, equipment, and productsFinalize and get approval for implementation

plan and use it to rollout new standards

PEPFARImplementing Partner

Benefits of Standardization in Zambia

• Negotiated maintenance contracts with purchase of reagents

• Decreased procurement costs through economies of scale

• Transferred stock to save $30K in potential losses from expiry

• Developed a priority list of product (185) to manage in the national laboratory logistics system

• Increased availability of standard products from 30% to 98%

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Challenges of Standardization in Kenya

• Significant debate on standardizing hematology machines

• 6 different systems existed at 16 sites, initially no consensus reached

• Unable to quantify and procure reagents and consumables for hematology

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Challenge Approach/ResultNon-standard equipment existing in system

Reagents not provided through the MOH supply chain

Service providers not following standard testing guidelines

National review of laboratory technical SOPs (dissemination pending)

Acceptance of partner donations of non-standard equipment

Parallel supply chains for reagents and consumables for non-standard equipment

Approaches to Address Challenges to Standardization in Zambia

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Key Lessons Learned in Standardization

• Standardization is a process• Requires time and resources

• The standardization process must be collaborative

• Participation of stakeholders from all levels• Standardization is a key first step in

optimizing and strengthening laboratory supply chains

PEPFARImplementing Partner

Thank you!