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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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slide1

Module 4:

Procurement and Inventory Management of Suppliesfor Xpert MTB/RIF

Global Laboratory Initiative – Xpert MTB/RIF Training Package

learning objectives
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
contents of this module
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
slide4

Supply management means…

Properly maintained and adequate supplies to ensure uninterrupted service and to minimize waste

structure of a supply management system national level
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
supply management system
Supply management system

Adapt to country-specific system

  • Describesupply management system(s) in your country
ordering of supplies
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
supplies required for xpert mtb rif provided by cepheid
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.

supplies required for xpert mtb rif genexpert cepheid
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

supplies required for xpert mtb rif provided by cepheid1
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

supplies required for xpert mtb rif provided by cepheid2
Supplies required for Xpert MTB/RIF:Provided by Cepheid

Software,

packageinsert

Empty data CD

5 XpertCalibrationCartridges

supplies required for xpert mtb rif not provided by cepheid
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.
supplies required for xpert mtb rif not provided by cepheid1
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)
supplies required for xpert mtb rif generator
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
supplies required for xpert mtb rif inverter
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)
supplies required for xpert mtb rif surge protector
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
supplies required for xpert mtb rif not provided by cepheid2
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)
supplies required for xpert mtb rif not provided by cepheid3
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)
supplies required for xpert mtb rif not provided by cepheid4
Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid
  • Personal protective equipment
    • Laboratory coats
    • Gloves
    • Respirators (optional)
supplies required for xpert mtb rif not provided by cepheid5
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)
stock management
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
stock log b ook required data
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
stock log book example
Stock Log Book: Example

To be customized by each country

Item name: ________________ Unit: ______________________

perform a stock count
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

data required for calculating supplies
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

examples of items required
Examples of items required
  • Items
    • Sputum containers
    • Xpert MTB/RIF kits
    • Concentrated bleach solution
    • Disposable Pasteur pipettes
calculate quarterly requirement for xpert mtb rif tests
Calculate quarterly requirementforXpertMTB/RIF tests

Adapt to country-specific system

*

* Or other time period

total number of tests performed in the previous quarter
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

calculation for one quarter of supply of an item c
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

example 1 to calculate one quarter of supply of xpert mtb rif cartridges c
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
example 1 to calculate reserve quantity d of xpert mtb rif kits
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)

example 1 to calculate xpert mtb rif supply stock on hand e
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
example 1 to calculate required quantity f of xpert mtb rif kits
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)

example 1 to calculate requested issued quantities of xpert mtb rif kits
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)
example 2 to calculate one quarter of supply of bleach solution c
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
example 2 to calculate reserve quantity d of bleach solution
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)

example 2 to calculate supply of bleach stock on hand e
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
example 2 to calculate quantity f of bleach solution to order
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)

example 2 to calculate quantities of bleach solution to request issue
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
exercise 1 calculate quarterly r equirements for xpert mtb rif testing
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
exercise 2 calculate quarterly r equirements for xpert mtb rif testing
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
placing orders
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
options for procurement of genexpert instruments and cartridges
Optionsforprocurement of GeneXpertinstruments and cartridges
  • Place an order directly with Cepheid France:Cepheid HBDC SAS, Vira Solelh, 81470 Maurens-Scopont, France; [email protected],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
prior to placing an order
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
information needed to place an order
Information needed to place an order
  • Number of GeneXpert machines/modules
  • Desktop or laptop computer
  • Number of Xpert MTB/RIF cartridges
  • Cataloguenumbers
  • Country of delivery
  • Destination airport
  • Contact details of receiving party 
  • Preferred date of delivery
after placing an order
After placing an order
  • Cepheid/localdistributorwill prepare quotation
  • Customer pays in advance to qualify for reduced pricing [high burden developing countries (HBDC) pricing]
upon receipt
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
proper storage of inventory
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)
summary
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
assessment
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?
slide57

Acknowledgements

The Xpert MTB/RIF Training Package has been developed by a consortium of GLI partners, including FIND, KNCV, US CDC, USAID, TB CARE I and WHO, with funding from USAID.

The modules are based on materials originally developed by FIND, KNCV and Cepheid.

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