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Procurement and Inventory Management of Supplies for Xpert MTB/RIF

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Presentation on theme: "Procurement and Inventory Management of Supplies for Xpert MTB/RIF"— Presentation transcript:

1 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

2 World Health Organization
31 March, 2017 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 World Health Organization
Supply management means… 31 March, 2017 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 Describe supply 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 calibration cartridges 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)
configuration Catalogue number With desktop computer With laptop GeneXpert 1 module GXI-1-D GXI-1-L GeneXpert 2 module GXII-2-D GXII-2-L GeneXpert 4 module GXIV-4-D GXIV-4-L GeneXpert 16 module GXXVI-16-D GXXVI-16-L 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
Cepheid product Catalogue number Number of tests Xpert MTB/RIF Assay CGXMTB/RIF-50 50 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
World Health Organization 31 March, 2017 Supplies required for Xpert MTB/RIF: Provided by Cepheid Cepheid product Catalogue number Number of tests Xpert Calibration Kit GXCALIB-100N-5 5 Software, package insert Empty data CD 5 Xpert Calibration Cartridges

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
Critical parameters Comment Suitable Specifications Voltage in your country Voltage of utility power supply Depends on a country UPS capacity in kilovolt-ampere (VA) Depends on equipment load plus 20 – 25 % 600 VA Back-up time Running time during power outage 4 – 6 min Transfer time Duration of transfer of equipment to the battery supply 0 - milliseconds

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-hazard bags 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
Laboratory supplies 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 amount ordered 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
World Health Organization 31 March, 2017 Stock Log Book: Example To be customized by each country Item name: ________________ Unit: ______________________ Physical count Requested Received Stock in hand Signature Units (No) Date

25 Perform a stock count All items must be accounted for. Everything that
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) Shelf life Lead time Period of time to cover with the supplies The following examples are for a facility-based supply management and can be customized for use at the central level

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

28 Calculate quarterly requirement for Xpert MTB/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 Item Name Quantity Sputum containers 1 piece Xpert MTB/RIF kits 1/50 kit (if each kit is 50 tests) Concentrated bleach solution (Example: 3%- note: the standard concentration varies from country to country) 1.5 ml (average of 100ml per day for 10 tests, diluted 6 times with water; final concentration 0.5% of sodium hypochlorite) Disposable Pasteur pipettes, 3ml

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 supply of 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 Calculated quantity of kits to order for one quarter 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 supply of 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 concentrated bleach equals 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 concentrated bleach

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 Calculated quantity of bleach to order for one quarter is: 900 ml (C) 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 Answer Calculated quarterly requirements for Xpert MTB/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 Answer Calculated quarterly requirements for Xpert MTB/RIF testing

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

49 Options for procurement of GeneXpert instruments and cartridges
Place an order directly with Cepheid France: Cepheid HBDC SAS, Vira Solelh, Maurens-Scopont, France; tel , fax  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]: es/find-negotiated-prices/xpert_mtb_rif.html

51 Information needed to place an order
Number of GeneXpert machines/modules Desktop or laptop computer Number of Xpert MTB/RIF cartridges Catalogue numbers Country of delivery Destination airport Contact details of receiving party  Preferred date of delivery

52 After placing an order Cepheid/local distributor will prepare quotation Customer pays in advance to qualify for reduced pricing [high burden developing countries (HBDC) pricing]

53 Upon receipt Inspect & Verify the Delivery of Orders :
Verify contents of order received with requisition Check integrity of received supplies Date each item received Store new shipment behind existing shipment in order to follow “FIRST EXPIRY – FIRST OUT” method Create or update records

54 Proper storage of inventory
Keep in a clean, dry, well-ventilated, and organized storage area Xpert MTB/RIF kits must be kept at 2-28C Store away from direct sunlight Organize existing and new shipments by expiry date (supplies with the soonest expiry date must be used first)

55 Summary Centralized (national, regional) management of Xpert MTB/RIF supplies integrated into the general purchase system should be organized and coordinated by the Government Some of the supplies required for using the Xpert MTB/RIF assay are not provided by Cepheid When calculating orders of supplies, consider your past consumption rate, your stock on hand, the shelf-life of the ordered material, the lead time, and your storage capacity, in order to assess quantity and frequency of orders Perform a stock count physically counting each item in the stock at the end of each month by a designated person, using a stock log book Place an order providing necessary information to Cepheid directly or to your local authorized distributor

56 Assessment What is supply management?
Why is a physical stock count necessary? Why is it important to maintain inventory records? How do you calculate supplies required? Why must supplies be stored properly?


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