Procurement Guidelines for Diagnostics and Laboratory Items

Transcription

1 Procurement Guidelines for Diagnostics and Laboratory Items AMDS Partners & Stakeholders Meeting March 2010, Geneva Ms Anita Sands Diagnostics & Laboratory Technologies Team Department of Essential Health Technologies 1

2 Problems encountered In-country Equipment downtime due to lack of maintenance Equipment downtime due to lack of reagents National testing algorithms not followed due to lack of certain products and/or products going off the market 2

3 Recent History The Maputo Declaration The Maputo Declaration on Strengthening of Laboratory Systems 3

4 Document Development WHO, UNICEF and UNDP met in Copenhagen to discuss the development of "UN Inter-agency Guidelines for Procurement of Diagnostics and Laboratory Equipment/Items" All UN agencies that procure diagnostics and/or laboratory items are invited to contribute to the proposed document. Chapter outline has been elaborated certain agencies will have expertise in certain areas 4

5 Chapter Outline Introduction Rationale for the guidelines Scope and Intended Audience Key Players in the Supply Chain Ministry officials (MoH, MoF, MoFA) Donors (funding agencies) Procurement agents Suppliers End-users 5

6 Process Outline PSM Plan Needs Assessment Exis1ng Na1onal Policy Budge1ng & 1melines Planning Phase Quan1fica1on Vendor Selec1on Solicita1on Bid Evalua1on Technical & commercial specifica1ons Implementing Phase Post market Surveillance Evaluate Supplier Performance M&E Phase Bid Award Delivery, installa1on & training Batch tes1ng Sampling from field sites 6

7 Planning Phase PSM planning Product selection Existing national policy including regulatory status, nationally validated testing algorithms, standardisation Technical considerations performance characteristics operational characteristics Commercial considerations Estimating requirements 7

8 Commercial Aspects Regulatory issues & embargos Cessation of production guarantee that support will continue if equipment manufacture is ceased: will reagents continue to be produced will spare parts continue to be produced will service continue as there may be a higher likelihood that equipment will break down, the closer it comes to the end of its life Inappropriate INCO terms Who ensures goods are shipped in appropriate conditions 8

9 Implementation Phase Vendor selection Product specifications Procurement methods & solicitation documentation Bid evaluation & award Contracting Delivery & installation 9

10 Laboratory Equipment Dedicated equipment closed vs. open systems integrated disease systems e.g. clinical chemistry, haematology, serology General laboratory equipment consumables, durables, renewables waste disposal & biosafety equipment competitive bidding 10

11 Laboratory Equipment Procurement processes may be different for different classes of equipment INDEPENDENT technical review of specifications is vital Problems with most technical specifications must be generic enough to encourage competition & discourage corruption/collusion must be specific enough to only select good quality products 11

12 Technical Support for Equipment Installation requirements Maintenance Regent rental/lease vs. capital purchase Training Initial & ongoing Technical hotline For end-users to call Language of manual/package insert 12

13 Laboratory Commodities Procurement of what is "required but not provided" to perform an assay is as important procurement of the test kit itself Instructions-for-use (package insert) should specify all the equipment & consumables required Useful to integrate laboratory needs for all disease programmes Can generally be procured through competitive bidding 13

14 Monitoring & Evaluation Phase Complaints Breakdown in cold chain during transport, too short shelf life upon delivery Vendor management Reporting to donors (funders) Increasingly time consuming Quality Assurance Post-market surveillance & vigilance procedures 14

15 Annexes Checklists to cover the 3 phases of the procurement process to ensure information is captured in a standardised manner, this can inform future decisions Planning Phase Implementation Phase Monitoring & Evaluation Phase 15