existing challenges – poc introduction lab technical working group

Existing Challenges – POC Introduction

Lab Technical Working Group

Jason Williams, Principal Laboratory Advisor, SCMS

January 20-21, 2013

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Overview

• Procurement perspective• Continuum of impact• Current CD4 situation• Existing POC challenges• Coordinated strategic response

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Procurement perspective

• Overarching challenges:• Limited stakeholder coordination and

communication regarding optimal use of diagnostic products

• Limited strategic and long term planning for the integration of new POC products coming to the market place

• Limited use of validated or accurate estimates of demand to inform deployment and work flow integration

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Continuum of impact

Har

mon

ized

Lab

Net

wor

k

Commodity Quantification

Instrument Coverage

Instrument Downtime

Forecast

Planning

Procurement

Distribution

Service Delivery

Point

Quality, Policy, & Guidelines Health System Strengthening Trends, Models & Regulation

Mar

ket D

ynam

ics

POC Integration

Emerging Technologies

Instrument validations

Global DonorsMinistry of Health

Health Service NetworkManufacturers

VendorsRegulatory Agencies

Supply Chain Optimization

Stakeholders

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PFSCM spend on laboratory commodities delivered through June 2012

$-

$5

$10

$15

$20

$25

$30

2007 2008 2009 2010 2011 2012

Mil

lio

ns

PfSCM Delivered Spend LOP thru June 2012

Flow Cytometry Biochemistry Hematology

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Optimization to reduce CD4 costs

• Optimizing laboratory procurement Selecting and procuring the right product within the national tiered laboratory system, with an appropriate throughput and complexity, that is sustainable within it’s regional and local setting.

• Strategy• Define the diagnostic coverage• Compare actual demand to capacity• Reduce instrument diversity• Increase utilization to reduce costs• Evidence based POC integration

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CD4: Finding the best cost / utilization

FACSCount versus FACSCalibur utilization price per test

Instrument Utilization Rate

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CD4 opportunities

• Greater efficiency may be established by maximizing CD4+ instrument utilization rates.

• Significant cost savings can be achieved by maximizing daily testing volumes per machine.

• Important to develop appropriate instrument placement strategies before procurement.

• Low-throughput point-of-care (POC) CD4+ testing platforms may contribute to lower costs per test.

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Existing POC Challenges

• Lengthy and unclear introduction/validation process

• Suboptimal instrument procurements and long term planning

• Optimizing existing lab infrastructure• Evidence based POC integration

• Long term impact not clearly understood• Instrument life span• Maintenance strategy development• Uptake – lessons learned

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Existing POC Challenges

• Limited government, donor, and technical coordination

• Competing priorities – treatment agenda (increased access) versus laboratory network development

• Vendor pressures (misleading)• Logistics (SDP not lab)

• Procurement, quantification, distribution, and maintenance

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Country X: PIMA POC example

• Program expansion driven by PMTC programs• No MOH laboratory involvement• Existing warranties have expired• Maintenance costs to be negotiated (currently at

$1,200/machine)

Overall 2012

Total number of sites 269

Sites with "0" consumption 46

Sites with consumption ≤ 1/day 91

% of sites with 0 or consuming ≤1/day 34%

% of sites with access to referral lab 30%

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Stakeholder relationships

REGULATORY

FDAWHOUSAID

CDC

OGAC

GF

UNITAID

SCMSUNICEF CHAI

PRs/VPP

ASLM ADVOCACY

Governments and Local Partners

TECHNICAL ASSISTANCE

PROCUREMENT

DONORS

MSF