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Module 4: Procurement and Inventory Management of Supplies for Xpert MTB/RIF

Module 4: Procurement and Inventory Management of Supplies for Xpert MTB/RIF. Global Laboratory Initiative – Xpert MTB/RIF Training Package. Learning Objectives. At the end of this module, you will be able to: List all supplies required for the optimal performance of Xpert MTB/RIF

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Module 4: Procurement and Inventory Management of Supplies for Xpert MTB/RIF

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  1. Module 4: Procurement and Inventory Management of Suppliesfor Xpert MTB/RIF Global Laboratory Initiative – Xpert MTB/RIF Training Package

  2. Learning Objectives At the end of this module, you will be able to: • List all supplies required for the optimal performance of Xpert MTB/RIF • Describe ordering processes • Explain the use and importance of the stock log book in maintaining an adequate inventory • Calculate supplies needed based on the number of tests performed during a specific period • Explain storage and shelf life requirements of Xpert MTB/RIF kits and other supplies

  3. Contents of this module • Supply list for Xpert MTB/RIF • Record keeping: Stock log book use and importance • Calculation of supplies to order • Ordering and receipt of supplies • Storage and shelf life of supplies

  4. Supply management means… Properly maintained and adequate supplies to ensure uninterrupted service and to minimize waste

  5. Structure of a supply management system: National level • Countries should consider implementing the centralized (national, regional) management of Xpert MTB/RIF supplies integrated into the general purchase system, as for microscopy or for drugs supplies • The system should be coordinated by the government and should include Ministry of Health, donors and partners

  6. Supply management system Adapt to country-specific system • Describesupply management system(s) in your country

  7. Ordering of Supplies • What to order? • From where? • How much? • How often? • How to assess the correctness of an order? • What is the lead time needed? • What is the reserve (buffer) stock needed? • Who is responsible for placing orders? • Always consider • the shelf-life of the ordered material, and your storage capacity under appropriate conditions

  8. Supplies required for Xpert MTB/RIF:Provided by Cepheid • GeneXpert instrument with computer (laptop or desktop) and barcode reader • When ordering, specify the working language to ensure a proper keyboard, etc. • Kits of Xpert MTB/RIF test cartridges • Kits of Xpert MTB/RIF calibrationcartridges Note: Cepheid can provide a UPS (uninterruptable power supply)*, which provides very limited power backup. However it is better to procure a UPS (and batteries, etc) locally *Specifications: Online UPS - Powervar. 800 VA capacity for a 4-module GeneXpert and computer; 110v or 220v depending on country. Minimal transfer time 4ms max. Extra batteries can be added to extend duration.

  9. Supplies required for Xpert MTB/RIF:GeneXpert (Cepheid) Note: a 4 module instrument shell can be procured with only 1 or 2 modules, for later expansion

  10. Supplies required for Xpert MTB/RIF:Provided by Cepheid Shelf life of open pouch: 6 weeks at 2–45oC • Sample reagent:8 ml bottle, 1 per test.Separate kit of 50 samples, reagent bottle also available. • Transfer pipettes:Sterile, individually packed; 1 per test, with 10 extra provided (ie, 60 pipettes with 50 cartridges) Xpert MTB/RIF kit consists of reagents and supplies sufficient for 50 tests

  11. Supplies required for Xpert MTB/RIF:Provided by Cepheid Software, packageinsert Empty data CD 5 XpertCalibrationCartridges

  12. Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid • Equipment • Biosafety supplies • Laboratory supplies • Personal protective equipment • Stationery • Anti-virus program for the computer. Norton internet security is provided for the first year only; renewal is at the user’s expense.

  13. Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid • Equipment • Power supply backup as needed (UPS and batteries, generator, inverter, surge protector) • Printer and printing cartridges • Timer • Thermometer • Vortex (optional)

  14. Supplies Required for Xpert MTB/RIF: UPS

  15. Supplies Required for Xpert MTB/RIF: Generator • Typical transfer time of automated generators 10 – 30 sec (UPS is still required) • Can be relatively inexpensive for purchase and running • Need for fuel storage and maintenance

  16. Supplies Required for Xpert MTB/RIF: Inverter • Converts low-volt power into a high-volt power • Can run on car batteries • Run time 2 – 12 hours (depending on reserve capacity of batteries and equipment load) • Transfer time can be less than 4 milliseconds (UPS can be still required)

  17. Supplies Required for Xpert MTB/RIF:Surge Protector • Protects electronics, including the UPS, from power surges and spikes • A power surge/spike, or transient voltage, is an increase in voltage significantly above the designated level in a flow of electricity • Even if increased voltage doesn't immediately break your machine, it may put extra strain on the components, wearing them down over time • Does not replace UPS

  18. Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid • Biosafety supplies • Bio-hazardbags • Tuberculocidal disinfectant (phenolic, bleach solution,70% alcohol, etc.) • Discard containers (for pipettes, sputum containers and used cartridges)

  19. Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid • Laboratorysupplies • Specimen containers • Additional transfer pipettes (optional) • Paper towels (for cleaning bench tops and external surfaces of instrument) • Soft tissue paper (for cleaning cartridge bays and plunger)

  20. Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid • Personal protective equipment • Laboratory coats • Gloves • Respirators (optional)

  21. Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid • Stationery • Laboratory registers and request/report forms • Printing paper • Permanents markers • Pens (red and blue or black) • Write-on stickers (optional)

  22. Stock management It is Good Laboratory Practice to have a designated person for supply management, who performs the following activities: • Performing a “stock count” • Maintaining proper inventory records • Determining how much to order to avoid stock-outs and expiring of cartridges • Placing orders properly • Inspecting and verifying supplies received • Ensuring proper storage of stock

  23. Stock log book: required data • Date and amountordered • Date of receipt of item • Amount received • Lot-number • Expiry date • Amount of used items • Balance of items still in stock

  24. Stock Log Book: Example To be customized by each country Item name: ________________ Unit: ______________________

  25. Perform a stock count • What is it?  Physically counting each item in the stock • When is it done?  Recommended at the end of each month • Who does it?  A designated person All items must be accounted for. Everything that comes in and goes out must be recorded

  26. Data required for calculating supplies • Number of tests performed (average per month) • Stock on hand (physical count) • Shelflife • Lead time • Period of time to cover with the supplies The followingexamples are for a facility-basedsupply management and canbecustomizedforuse at the central level

  27. Examples of items required • Items • Sputum containers • Xpert MTB/RIF kits • Concentrated bleach solution • Disposable Pasteur pipettes

  28. Calculate quarterly requirementforXpertMTB/RIF tests Adapt to country-specific system * * Or other time period

  29. Quantities required for one Xpert MTB/RIF test (B) To be customized by each country

  30. Total number of tests performed in the previous quarter The value (A) equals the number of Xpert MTB/RIF tests performed during the previous quarter

  31. Calculation for one quarter of supply of an item (C) • The value (C) equals the quantity of an item required for one quarter • Calculate (C) by multiplying the number of tests performed during a quarter (A) by the amount of the item needed for one examination (B), therefore: A x B = C

  32. Example 1: to calculate one quarter of supplyof Xpert MTB/RIF cartridges (C) • In the last quarter, you performed 600 Xpert MTB/RIF tests (A) • You need 0.02 of Xpert MTB/RIF kits (50 tests in kit) per test (B), so how many kits will you need for the next quarter (C)? • A x B = C • 600 tests x 0.02 kit/test = 12 kits

  33. Example 1: to calculate reserve quantity (D) of Xpert MTB/RIF kits • The value (D) equals a one month consumption quantity of an item that must be kept as a reserve • The value (D) is equal to (C)/3, the quantity of an item calculated for one month: D= C/3 • Reserve stock of Xpert MTB/RIF kits equals 12 kits (C) /3= 4 kits (D)

  34. Example 1: to calculate Xpert MTB/RIF supply, stock on hand (E) • The value (E) equals the stock on hand • Determine (E) by the an actual physical count of existing stock (inventory) • Assume stock in hand is 3 Xpert MTB/RIF kits

  35. Example 1: to calculate required quantity (F) of Xpert MTB/RIF kits • The value (F) equals the quantity required for one quarter (C) plus the quantity required for one month reserve (D) less the stock on hand (E) • Calculate (F) as follows: (F)= C+D-E • Stock is hand is 3 Xpert MTB/RIF kits • Calculatedquantity of kits to order foronequarter is: 12 (C) + 4 (D) – 3 (E) = 13 (F)

  36. Example 1: to calculate requested / issued quantities of Xpert MTB/RIF kits • Round up the calculated quantity to a quantity consistent with the unit of issue • The calculated quantity of kits is 13 • The order unit is box (50 tests) • Order 13 boxes (650 tests)

  37. Example 2: to calculate one quarter of supplyof bleach solution (C) • In the last quarter, you performed 600 Xpert MTB/RIF tests (A) • You need 1.5 ml of concentrated bleach solution per test (B), so how much concentrated bleach solution will you need for the next quarter (C)? • A x B = C • 600 tests x 1.5 ml/test = 900 ml

  38. Example 2: to calculate reserve quantity (D) of bleach solution Adapt to local setting and supplies’ shelf life • The value (D) equals a one month consumption quantity of an item that must be kept as a reserve • The value (D) is equal to (C)/3, the quantity of an item calculated for one month: D= C/3 • Reserve stock of concentratedbleachequals 900 ml (C) /3=300 ml (D)

  39. Example 2: to calculate supply of bleach, stock on hand (E) • The value (E) equals the stock on hand • Determine (E) by the an actual physical count of existing stock (inventory) • Assume stock in hand is 400 ml of concentratedbleach

  40. Example 2: to calculate quantity (F) of bleach solution to order • The value (F) equals the quantity required for one quarter (C) plus the quantity required for one month reserve (D) less the stock on hand (E) • Calculate (F) as follows: (F)= C+D-E • Stock in hand is 400 ml • Calculatedquantity of bleach to order foronequarter is: 900 ml (C) + 300 ml (D) – 400 ml (E) = 800 ml (F)

  41. Example 2: to calculate quantities of bleach solution to request/issue • Round up the calculated quantity to a quantity consistent with the unit of issue • The calculated quantity of bleach solution is 1824 mL, round it up to 2 liters • The order unit is 1 liter bottle • Order 2 bottles

  42. Exercise #1: Calculate quarterly requirements for Xpert MTB/RIF testing • Use worksheet labeled exercise #1 • Work individually • Use sample data provided • Time allowed: 30 minutes

  43. Exercise #1: Calculate quarterly requirements for Xpert MTB/RIF testing

  44. Exercise #1 AnswerCalculated quarterly requirements for XpertMTB/RIF testing

  45. Exercise #2: Calculate quarterly requirements for Xpert MTB/RIF testing • Use worksheet labeled exercise #2 • Work individually • Use sample data provided • Time allowed: 30 minutes

  46. Exercise #2: calculate quarterly requirements for Xpert MTB/RIF testing

  47. Exercise #2 AnswerCalculated quarterly requirements for XpertMTB/RIF testing

  48. Placing orders Adapt to country-specific system • Procedure for placement orders depends on a source of funding • Discusslocalprocurement procedures and contigency plan in case of shortages of supplies

  49. Optionsforprocurement of GeneXpertinstruments and cartridges • Place an order directly with Cepheid France:Cepheid HBDC SAS, Vira Solelh, 81470 Maurens-Scopont, France; ordershbdc@cepheidhbdc.com,tel. +33 563 825 333, fax +33 563 825 301 or • Place an order through a Cepheid local authorized distributor. Consult Cepheid for contacts of your local provider • Other project-specific procurement mechanisms are available. WHO may also be able to assist, via the Global Drug Facility

  50. Prior to placing an order • Follow national guidelines for pre-authorization of equipment & supplies if required • Prepare documentation for importation & custom clearance or exemption of import tax (if applicable) • Start well in advance, as preparation can take months • Consult Cepheid about timelines of shipment of order, and what is the guaranteed minimum shelf life of cartridges to be ordered • Verify if your country is among the 145 eligible countries to get GeneXpert and cartridges at reduced prices [high burden developing countries (HBDC) pricing]: http://www.finddiagnostics.org/about/what_we_do/successes/find-negotiated-prices/xpert_mtb_rif.html

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