CONTACTDepartment of Essential Medicines and Health ProductsWorld Health Organization20 Avenue AppiaCH-1211 Geneva 27SwitzerlandE-mail: diagnostics@who.intwww.who.int/diagnostics_laboratory

Diagnostics and Laboratory Technology

978 92 4 150029 6

Manual for procurement of diagnostics and related laboratory items and equipment

Diagnostics anD Laboratory technoLogy

World Health Organization 2013

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Diagnostics anD Laboratory technoLogyContents

Abbreviations 2

Glossary 3

Scope and intended audience 4

1 Introduction 41.1 Diagnostics-specific procurement challenges 41.2 Process for procurement of diagnostics and related laboratory items/equipment 5

2 Planning phase 62.1 needs Assessment 6

2.1.2 Key stakeholders 72.2 Procurement planning 72.3 Product selection using national guidance and policy 7

2.3.1 standardization and harmonization 72.3.2 testing strategies and nationally validated testing algorithms 82.3.3 Regulatory approvals 82.3.4 Performance and operational characteristics 92.3.5 specific issues related to laboratory equipment 102.3.6 Consumables and durables 122.3.7 Infrastructure and utilities 12

2.4 estimating requirements 122.4.1 Quantification 132.4.2 Forecasting 13

3 Implementation phase 143.1 Product specifications 143.2 Procurement methods and solicitation documentation 15

3.2.1 Vendor sourcing and pre-selection 153.2.2 solicitation of bid 15

3.2 Bid evaluation 183.2.1 Bid response 183.2.2 Preliminary examination of bids 183.2.3 evaluation of substantially responsive bids 19

3.3 Contracting 193.3.1 Contracting for equipment 203.3.2 Requirements for installation 213.3.3 training requirements 213.3.4 Maintenance 21

4 Monitoring and evaluation phase 214.1 Monitoring procurement practices 214.2 evaluating supplier performance 224.3 Post market surveillance for diagnostics 22

4.3.1 Complaints monitoring 224.3.2 Lot testing of consignments 224.3.3 sampling of tests from field conditions 22

5 Donations 22

6 Bibliography 23

7 Annexes 24Annex A. PsM Planning Phase Checklist 24Annex B: Product selection Decision tree 25Annex C: example technical specifications for diagnostics and generic laboratory products 26

2 Manual for procureMent of diagnostics and related laboratory iteMs and equipMent

Diagnostics anD Laboratory technoLogyABBReVIAtIons

CD4 CD4 T-lymphocyteCFR Cost and FreightCIF Cost Insurance and FreightEOI Expression of InterestEQA external quality assessmentEQAS external quality assessment schemeGFATM The Global Fund to fight AIDS, Tuberculosis and MalariaICB International Competitive BiddingICC International Chamber of CommerceINCOTERM International Commercial TermsISO International Standards OrganizationITB Invitation to BidLTA Long Term AgreementNRA National Regulatory AuthorityNRL National Reference LaboratoryPEPFAR President's Emergency Plan for AIDS ReliefPO Purchase OrderPMI President's Malaria InitiativePSM Procurement and Supply ManagementQA quality assuranceQC quality controlQMS quality management systemRFP Request for ProposalRFQ Request for QuoteSOP Standard Operating ProcedureSOW Scope of WorkTCO Total Cost of OwnershipTOR Terms of ReferenceUN United NationsUPS uninterrupted power supplyWHO World Health Organization

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Diagnostics anD Laboratory technoLogyGLossARy

Analyte Substances that are identified or measured by the test e.g. antibodies or antigen

Consumables Items that are used once during testing and are not reused e.g. gloves, pipette tips, etc.

Diagnostics In this document refers to an in vitro diagnostic medical device such as rapid diagnostic test, enzyme immunoassays, and other formats.

Durables Items that can be reused for multiple tests such as glassware, plastic ware, etc.

Equipment Items such as analyzers that may be used for a range of specific tests and general laboratory equipment such as centrifuges, pipettes and incubators

External quality assessment A programme designed to assess laboratory performance, i.e. assessment of the quality of the entire testing process from collection of specimen, the testing procedure, to the reporting of testing results. Usually composed of one or more of the following activities: site visits, participation in external quality assessment schemes/proficiency testing and inter-laboratory comparison.

PSM plan Procurement and supply chain management plan

Quality assurance Planned and systematic activities to provide confidence that an organization fulfills requirements for quality, i.e. to ensure the quality of the testing process including quality of diagnostics and items/equipment.

Quality control A measure to control of the quality of the test itself. QC does not totally control for the provision of correct testing results.

Quality management system A management system, comprising an organizational structure, procedures, processes and resources, to direct and control an organization with regard to quality.

Reagents Chemical and biological components used in the testing process

Test kits Individual platforms or devices that include reagents required to carry out a test

WHO Prequalification of Diagnostics programme

An assessment of the performance/operational characteristics and manufacturing quality of diagnostics, as performed by WHO

4 Manual for procureMent of diagnostics and related laboratory iteMs and equipMent

Diagnostics anD Laboratory technoLogysCoPe AnD IntenDeD AuDIenCeThe purpose of the Manual for Procurement of Diagnostics and Related Laboratory Items and Equipment is to provide information on procurement processes specific to HIV and related diagnostics, laboratory items and equipment. This Manual is not intended to replace existing guidance on basic procurement processes but rather to enhance and extend current processes to include specific issues related to diagnostics and related items/equipment that are considered essential to ensure high quality testing services.

The intended audience includes procurement officers, HIV programme managers and end-users of diagnostics, staff in United Nations (UN) agencies and non-governmental organizations (NGOs) who are responsible for the selection, use and procurement of diagnostics and related laboratory items and equipment.

Users of this manual who procure with financial resources from multilateral or bilateral agencies or sources other than national funds will be obliged to also follow the rules, regulations and policies of the funding/procuring organization.

The following documents are used more generally to guide UN procurement and may provide the basis for other procuring organizations to organize their procurement processes:1. UN Procurement Practitioners Handbook, Revision 1.1

(September 2012) Web address https://www.ungm.org/pph/pr01.html

2. UN Procurement Manual, Revision 06, (March 2012) Web address http://www.un.org/depts/ptd/manual.htm

See section 6 (bibliography) for further useful reading.

1 IntRoDuCtIonAccess to accurate, safe and appropriate diagnostics and reliable laboratory services is paramount for diagnosis and disease management, surveillance and securing a safe blood supply. However, testing results are only of value to those making clinical decisions if the test results reported are timely and correct.

Selection and procurement of diagnostics and laboratory technologies is often challenging given the wide choice of products and suppliers in the global market. Understanding of the needs at each level of the health system is critical and

should be the first step. Clear technical specifications and good procure