specification of laboratory items for effective procurement of lab … · annual amds stakeholders...

Annual AMDS Stakeholders & Partners Meeting 2011

Specification of laboratory items for effective procurement of lab items:

lessons, current status and proposed way forward

World Health OrganizationMarch 28 & 29, 2011Geneva, Switzerland

PEPFARImplementing Partner

2

Overview based on recent SCMS procurement

• PEPFAR funding only. • Values include equipment, maintenance and

reagents. • The category that could give the most return from

harmonization and standardization is analyzers and associated reagents

• Analyzers and reagents represent 13% of total procurement spend

• and 36% of non-pharmaceuticals spend• SCMS currently procures for approximately 35

different analyzers in PEPFAR countries


3

Harmonization Versus Standardization

• Harmonization is a cooperation between governments to make laws and regulations more uniform and coherent

• Standardization is the process of establishing a technical standard, which could be a standard specification, standard test method, standard definition, standard procedure or practice.


4

The Tiered Laboratory Model per Maputo

• Regional laboratories attending to local clinics will perform simple and more regularly requested sample analyses.

• The majority of primary care laboratory tests conducted on blood or urine can be performed in laboratories that are run from within peripheral health centers. These rapid tests, or simple automated assays, can be carried out by technologists, including the reporting back of results to the clinical colleagues.

• Referral centers will have a higher level in the laboratory structure and perform more specialized tests, or those tests which are performed less frequently.

• Public Health Reference Laboratories• Tests that are required infrequently• Tests that are not cost-effective to run at multiple centers• Tests that require rare skills or a set of special conditions that are available in a

limited number of laboratories e.g. BSL 3 laboratories• Development of new assays, as new technology becomes available• Setting of national standards and norms• Assisting nationally with issues such as quality assurance and training• National tracking of disease epidemiology• National outbreak control capabilities


5

Total Dollars Delivered by Category

Total Delivery: Life of Project$718M Total Spend

Gloves - $3M0%

Analyzers - $86M13%

Non ARV drugs - $40M6%

Food Products - $3M0%

Other Commodities - $13M2%

Clinical Products - $25M3%

Lab Products - $38M5%

Male Circumcision Kits - $3M0%

Diagnostic Test Kits - $73M10%

Antiretrovirals - $434M61%


6

Analyzers by Lab Category

Total Analyzer Delivery - Life of Project13% of Total Spend36% of non-Pharma Spend$86M Life of Project Spend

FlowCytometry - $53.5M

63%

Hematology - $15.2M18%

Biochemistry - $14.9M

17%

Imunoassay - $0.9M1%

Molecular - $0.7M1%


7

Flow Cytometry (CD4) by Country

Flow Cytometry by Country: Life of Project - $54M7% of total Spend62% of Analyzer Spend

$-

$2

$4

$6

$8

$10

$12

$14

$16

ET - Ethi

opia

KE - Ken

yaMZ -

Moz

ambiq

ueCI -

Cote D

'Ivoir

eZM

- Zam

biaNG - N

igeria

HT - H

aiti

RW - Rwan

daVN - V

ietna

mTZ

- Tan

zania

BW - Bots

wana

Non-Fo

cus C

ountr

iesM

illio

ns

Pima

Other

Vitros

Guava

Beckman

Pointcare

CyFlow

FACSCalibur

FACSCount


8

Hematology by Country

Hematology by Country: Life of Project - $15M2% of Total Spend 18% of Analyzer Spend

$0.0

$0.5

$1.0

$1.5

$2.0

$2.5

$3.0

$3.5

$4.0

ET - Ethi

opia

KE - Ken

yaCI -

Cote D'Iv

oire

NG - Nige

riaRW - R

wanda

ZM - Zam

bia

HT - H

aiti

MZ - M

ozam

bique

BW - Bots

wana

TZ - T

anza

niaM

illion

s

Beckman

HumanHyCel

MAXM

AU400ImmunoTrol

Other

HumaCountActDiff

CellTacCellDyn

Sysmex


9

Biochemistry by Country

Biochemistry by Country: Life of Project - $15M2% of Total Spend17% of Analyzer Spend

$-

$0.5

$1.0

$1.5

$2.0

$2.5

$3.0

$3.5

$4.0

$4.5

$5.0

ZM - Zam

biaCI -

Cote D

'Ivoir

eNG - N

igeria

ET - Ethi

opia

KE - Ken

yaMZ - M

ozam

bique

HT - Haiti

RW - Rwan

daTZ - T

anza

niaBW

- Bots

wanaGY - G

uyan

a

Mill

ions

AMS

MGIT

Konelab

Sw elab

Amplicor

Kenza

Elitech

DiaSys

Roche-Hitachi

Humalyser

Humastar80

BT

COBAS Integra

AU400

COBAS

Reflotron

Vitros

Other

Human

Fully

ABX


10

All Analyzers by Country

All Analyzers by Country: Life of Project

$-

$2

$4

$6

$8

$10

$12

$14

$16

$18

$20

ET - Ethi

opia

KE - Ken

yaZM -

Zambia

CI - C

ote D

'Ivoir

eMZ -

Mozam

bique

NG - Nige

ria

HT - Haiti

RW -

Rwanda

BW -

Botswana

VN - Viet

nam

TZ - Tan

zania

All oth

er

Milli

ons

Cl ima

HyCel

MAXM

Pima

AMS

Konelab

Swelab

Kenza

El i tech

DiaSys

Roche-Hi tachi

MGIT

ImmunoTr ol

Humalyser

TaqMan

Humastar 80

BT

Ampl icor

COBAS Integr a

HumaCount

Guava

Beckman

AU400

Ar chi tect

COBAS

Ref lotr on

Pointcar e

ActDi f f

Vi tr os

Human

Other

Ful ly

CyFlow

Cel lTac

ABX

Cel lDyn

Sysmex

FACSCal ibur

FACSCount


11

Rapid Diagnostic Kits - 13 HIV kits = 94% of kit spend

Item Description Total %HIV, Determine kits and accessories 41,402,957$ 57% HIVHIV, Uni-Gold HIV Kit, 20 Tests 7,800,265$ 11% HIVHIV, Bioline kits and accessories 6,430,200$ 9% HIVHIV, Stat-Pak HIV 1 / 2 Kit, 20 Tests 4,923,650$ 7% HIVHIV, Colloidal Gold, 1+2 Antibody, 50 Tests 4,160,263$ 6% HIVHIV, Genie II HIV-1/HIV-2 Kit, 40 Tests 914,588$ 1% HIVHIV, Capillus HIV-1/HIV-2 Kit, 100 Tests 570,789$ 1% HIVHIV, First Response v3.0, HIV 1-2-O, 30 Tests 467,504$ 1% HIVHIV, Vironostika test kit and variations 447,872$ 1% HIVHIV, OraQuick Rapid HIV-1/2 Antibody Kit, 100 Tests 425,950$ 1% HIVHIV, Murex HIV 1.2.0, ELISA Kit, 96 Tests 279,588$ 0% HIVHIV, Genscreen Ultra HIV Ag-Ab, ELISA Kit, 96 Tests 283,809$ 0% HIVHIV, Clearview Complete HIV 1/2 Kit, 25 Tests 158,475$ 0% HIVHIV, other 362,577$ 0% 94%Syphilis Bioline 3.0, Multi-device, 100 Tests 1,214,385$ 2% SyphilisSyphilis RPR Kit, 653,792$ 1%Hepatitis, Determine HBsAg Kit, 100 Tests 471,602$ 1% HepatitisPregnancy Test Kit, Rapid, 100 Tests 534,927$ 1% PregnancyMisc Other Test kits 1,248,130$ 2% Other

Grand Total 72,897,268$


Specification challenges are reducing through use of on-catalog items

Lab Items Procured on-Catalog

0%

20%

40%

60%

80%

100%

2007-12 2008-04 2008-08 2008-12 2009-04 2009-08 2009-12 2010-04 2010-08

Off Catalog

On Catalog


13

• Limited information systems to track consumption and stock to build accurate forecasts and create long term supply plans

• Limited leverage over global suppliers • Multiple orders need to be scheduled with

manufacturer due to large quantities or shelf-life requirements

• With limited supply planning unable to maximize freight options and potential freight cost savings

• Limited local stock-holding and distribution leads to long shipping times

• Unpredictable import processes that can vary from shipment to shipment.

Continuing challenges to commodity security and cost savings on laboratory commodities


Lead Time breakdown

Off Catalog

On Catalog

Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

PQ in-country process

Supplier quotations

Country approvals

Supplier Fulfilment

Shipping Air

Shipping Ocean

Customs

Delivery

Total 16 - 19 Weeks


Next steps for further improvement

Comprehensive analysis of number and type of machines in operation which the MOH wishes to control

Evaluation of machines to verify appropriate capacity machines are in the right locations: Based on the Maputo defined tiered lab recommendations - rational procurement

Application of cost-effective procurement mechanisms for the defined machines limiting support of equipment not in MOH plan and reducing emergency orders


16

• A Pan-African professional body that will work with countries to advocate for the critical role and needs of laboratory medicine.

• Serve as a professional body to guide laboratory network development and strengthening efforts in Africa

• Facilitate and engender South-South, North-South collaborations, partnerships and resource mobilization

• Developing and guiding the process of harmonization and certification of laboratory medicine training

• Working with WHO and others to develop and implement laboratory policies and guidelines in Africa

• Strengthening existing laboratory professional associations and societies and aiding in their development

• Coordinating the development and certification of laboratory medicine continuing education

• Establishing a peer-reviewed journal in laboratory medicine in Africa

African Society for Laboratory Medicine: ASLM


African Society for Laboratory Medicine: ASLM

Launch presentation on Global Health TV:

http://www.globalhealthtv.com/news/v/better_labs_will_mean_improved_health_in_africa/to/latest_news/


18

Thank You

David JamiesonDeputy Director, Project Planning and Global PartnershipsSupply Chain Management System 1616 N. Ft. Myer Drive, 12th FloorArlington, VA 22209 USA+1.571 227 [email protected]

specification of laboratory items for effective procurement of lab … · annual amds stakeholders...

Documents