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Procurement of diagnostics: SCMS update on procurement of standardized laboratory items WHO AMDS Annual Partners and Stakeholders Meeting David Jamieson, SCMS Deputy Director, Global Partnerships May 8, 2013, Geneva.

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Page 1: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

Procurement of diagnostics: SCMS update on procurement of

standardized laboratory items

WHO AMDS Annual Partners and Stakeholders Meeting

David Jamieson, SCMS Deputy Director, Global Partnerships

May 8, 2013, Geneva.

Page 2: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Contents

1. Summary of recent procurement

statistics

2. Recent experience from technical

assistance to harmonize and optimize

diagnostic equipment choices.

2

Page 3: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Lab products have become a larger proportion of the total

SCMS procurement since 2009

3

0

50

100

150

200

250

300

350

400

2009 2010 2011 2012

Va

lue

of

De

live

rie

s (U

SD)

Mill

ion

s

Value of SCMS Deliveries by Commodity Type, 2009-2012

ARV - Antiretrovirals - ARV - Antiretrovirals DRUG-Non ARV drugs

HRDT - HIV Rapid Diagnostic Tests LAB - Lab Equipment & Medical Supplies

MC - Male Circumcision Kits Other

Page 4: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

SCMS sources its commodities worldwide, with the

majority by value sourced from India

4

Asia, 0.9% Canada, 0.1%

Central Africa, 0.4%

Central/South America and Caribbean,

1.3% East Africa,

2.9%

Europe, 16.7%

India, 60.0%

Middle East, 7.5%

Southern Africa, 6.4%

USA, 3.2%

West Africa, 0.6%

Percentage of Total Delivered Value by Region, 2012

Page 5: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Over the life of the SCMS project, reagents and analyzers

comprise the majority of the lab commodity value

5

Lab Supplies/Equipment,

$101,378,890

MC Kits, $18,917,559

Test-Other, $5,274,425

Reagents/Analyzers, $183,957,744

HIV Test, $129,841,869

Total Delivered Value by Lab Commodity (USD), SCMS

Page 6: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Determine represents by far the majority of HIV Test

kits delivered by SCMS

6

0

5

10

15

20

25

30

35

40

2009 2010 2011 2012

Val

ue

of

Del

iver

ies

(USD

)

Mill

ion

s Delivered Value of HIV RTK by Supplier, 2009-2012

Determine Uni-Gold Bioline Colloidal Gold Stat-pak All other

Page 7: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

The overall market for reagents and analyzers remains

extremely complex, with FACSCount the largest product

7

FACSCount FACSCount

FACSCount

FACSCount

0

10

20

30

40

50

60

2009 2010 2011 2012

Val

ue

of

Del

iver

ies

(USD

) M

illio

ns

Delivered Value of Reagents/Analyzers by Supplier, 2009-2012

X-Ray

Vitros DT

Vitros 350

UPS

TB

Sysmex

Syphilis

Sharps

Reflotron

QBC

Pregnancy

Pointcare

Pima

Phlebotomy

MGIT

Meningitis

Medonic

MAXM

M2000

Large GloveordersKonelab

Kenza

Page 8: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

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Asia, 1.6%

Canada, 0.3% Central Africa, 1.9%

Central/South America and Caribbean,

4.2%

East Africa, 9.1%

Europe, 51.3% India/Pakistan, 1.4%

Middle East, 2.1%

Southern Africa, 17.3%

USA, 8.1%

West Africa, 2.8%

Percentage of Total Delivered Value by Region, 2012

The majority of lab commodity deliveries by value are

sourced from Europe

Page 9: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Within lab commodities, reagents and analyzers make up

the largest proportion of SCMS deliveries

9

0

20

40

60

80

100

120

2009 2010 2011 2012

Va

lue

of

Del

ive

ries

(U

SD)

Mill

ion

s Value of Deliveries by Lab commodity, 2009-2012

Lab Supplies/Equipment MC Kits Reagents/Analyzers TEST - HIV Test-Other

Page 10: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

In 2012, flow cytometry represented nearly 65% of total value

of reagents and analyzers

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Biochemistry, 12%

Flow Cytometry,

65%

Hematology, 13%

Immuno, 2%

Molecular, 8%

Percentage of value by Reagent/Analyzer Type, 2012

Page 11: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Becton Dickinson represents 66% of the total value for flow

cytometry reagents and analyzers

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Becton Dickinson FACS, 66%

THL, 14%

Partec, 6%

All Other, 15%

Percentage of Value for Flow Cytometry Reagent/Analyzers by Supplier, 2012

Page 12: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

The number of items purchased more than 20 times per year

has increased since 2009

12

0

1000

2000

3000

4000

5000

6000

2009 2010 2011 2012

Nu

mb

er o

f it

em

s d

eliv

ere

d

Number of Times an Item is Ordered per Year

Number of times individual items were ordered each year, 2009-2012

1 2,9 10,19 20+

Page 13: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

13

0

10

20

30

40

50

60

70

80

90

100

2009 2010 2011 2012

Val

ue

of

Del

iver

ies

(USD

) M

illio

ns

Number of Times an Item is Ordered per Year

Item value by number of times item ordered each year, 2009-2012

1 2,9 10,19 20+

Value of items purchased more than 20 times purchased per

year has increased significantly since 2009

Page 14: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

14

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

2009 2010 2011 2012

Nu

mb

er o

f It

ems

Del

iver

ed

Total number of items delivered for items shared by multiple countries, 2009-2012

Unique to One Shared by Two Shared by Three +

The total number of items purchased by three or more

countries each calendar year has also increased

Page 15: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

The total value for items purchased by three or more countries

during a calendar year has increased since 2009

15

0

20

40

60

80

100

120

2009 2010 2011 2012

Va

lue

of

Del

ive

ries

(U

SD)

Mill

ion

s Total value of Items shared by multiple countries, 2009-2012

Unique to One Country Shared by Two Shared by Three+

Page 16: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Recent experience from technical

assistance to harmonize and optimize

diagnostic equipment choices

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Page 17: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

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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Page 18: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

CD4: Finding the best cost/utilization

FACSCount versus FACSCalibur utilization price per test

Instrument Utilization Rate

Page 19: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Country A: Service data

Country A Machines % Distribution Lab Level % Utilization Dx Contribution

All Instruments 138 33% 100%

FACSCount 51 37% Level I - Primary outpatient 55% 40%

FACSCount 55 40% Level II - District labs 44% 35%

FACSCount 12 9% Level III - Regional/Provincial Lab 22% 4%

FACSCount 5 4% Level IV - National Reference Lab 53% 4%

FACSCount Total 123 89% 47% 82%

FACSCaliber 0 0% Level I - Primary outpatient 0% 0%

FACSCaliber 3 2% Level II - District labs 7% 2%

FACSCaliber 7 5% Level III - Regional/Provincial Lab 8% 5%

FACSCaliber 5 4% Level IV - National Reference Lab 26% 11%

FACSCaliber Total 15 11% 14% 18%

Page 20: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Country B: Service data

Country B Machine #s % Distribution Lab Level % Utilization DXcontribution

All Instruments 105 11% 100%

Guava 30 29% 12% 29%

Cyflow 2 2% 0% 1%

FACSCount Level I - Primary outpatient 0%

FACSCount 11 10% Level II - District labs 7% 7%

FACSCount 51 49% Level III - Regional/Provincial Lab 9% 30%

FACSCount 2 2% Level IV - National Reference Lab 33% 1%

FACSCount Total 64 61% 10% 38%

FACSCaliber Level I - Primary outpatient 0%

FACSCaliber Level II - District labs 0%

FACSCaliber 2 2% Level III - Regional/Provincial Lab 5% 7%

FACSCaliber 7 7% Level IV - National Reference Lab 15% 25%

FACSCaliber Total 9 9% 13% 32%

Page 21: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Case study: Ethiopia

• SCMS partnered with USAID and the CDC in a lab

optimization procurement initiative to help the Ethiopian

government maximize donor funding for lab equipment

procurement and distribution

• Analyzed CD4 testing needs by researching the number of

patients served at each site, ART and pre-ART patient targets

and testing trends

• Moved from FACSCalibur machines for lab ART monitoring

sites to less costly FACSCount machines for lower-volume

sites

Saved over $600,000 in the cost of instruments and

reagents within the first year and an additional $100K every

year after

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Page 22: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Eight questions as guide for harmonization

1. Is the diagnostic instrument on the nationally

approved instrument list?

2. Is the request to replace existing old instruments? If

yes, is there an instrument replacement strategy?

3. If these instruments are for new locations, is there an

instrument deployment plan for the proposed

instruments?

4. What is the current estimated diagnostic capacity for

this particular instrument type in country?

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Page 23: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Eight questions as guide for harmonization

5. What is the diagnostic burden at the proposed sites?

Is the instrument selected appropriate, based on

instrument capacity vs. diagnostic demand?

6. Is there suitable infrastructure at the proposed sites -

any additional peripheral needs?

7. Is there expected service delivery expansion at the

proposed sites? (scale up)

8. Have the additional costs of reagents, staff training,

maintenance been considered - what are the funding

sources and estimated costs?

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Page 24: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

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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Page 25: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Country X: PIMA POC example

• Program expansion driven by PMTCT programs

• No MOH laboratory involvement

• Existing warranties have expired

• Maintenance costs to be negotiated (currently at

$1,200/machine)

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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%

Page 26: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Types of service and maintenance contracts

• Instrument based service and maintenance –

negotiated rate per instrument

• Reagent and service package – negotiated

reagent premium inclusive of service and

maintenance – used with existing machines

or newly purchased instruments

• Reagent Rental/Lease – negotiated reagent

premium inclusive of service and maintenance

and rental costs for instrument

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Page 27: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

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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Page 28: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

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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Page 29: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

Takeaways for a national laboratory strategy

• For optimized value and performance central

oversight of all laboratory instruments required

• Effective instrument and vendor management

systems are necessary

• Maintenance and instrument replacement

strategies are needed

• Reductions in instrument diversity

• Leverage data to negotiate contract terms and

establish best fit solutions

• Major opportunities remain for improved value

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Page 30: SCMS update on procurement of standardized laboratory itemsVitros DT Vitros 350 TB Sysmex Syphilis Sharps Reflotron QBC Pregnancy Pointcare Pima Phlebotomy MGIT ... Eight questions

PEPFAR Implementing Partner

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For more… www.scms.pfscm.org

For www.scms.pfscm.org…

www.scms.pfscm.org

Thank you!

Questions?

Mr. David JAMIESON

Partnership for Supply Chain Management (PFSCM)

1616 N. Ft. Myer Drive, 12th Floor

Arlington, VA 22209 USA

Office: +1.571 227 8669

Cell phone: +1 202 316 4999

Email: [email protected]

2012

Finalist