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

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Module 4:

Procurement and Inventory Management of Suppliesfor 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

  • 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

  • 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


Supply management means…

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


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

Adapt to country-specific system

  • Describesupply management system(s) in your country


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

  • 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)

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 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 Cepheid

Software,

packageinsert

Empty data CD

5 XpertCalibrationCartridges


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 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: UPS


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

  • 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

  • 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 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 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 Cepheid

  • Personal protective equipment

    • Laboratory coats

    • Gloves

    • Respirators (optional)


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

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 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

To be customized by each country

Item name: ________________ Unit: ______________________


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

  • 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

  • Items

    • Sputum containers

    • Xpert MTB/RIF kits

    • Concentrated bleach solution

    • Disposable Pasteur pipettes


Calculate quarterly requirementforXpertMTB/RIF tests

Adapt to country-specific system

*

* Or other time period


Quantities required for one Xpert MTB/RIF test (B)

To be customized by each country


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)

  • 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 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

  • 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)

  • 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

  • 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

  • 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 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

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)

  • 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

  • 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

  • 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 requirements for Xpert MTB/RIF testing

  • Use worksheet labeled exercise #1

  • Work individually

  • Use sample data provided

  • Time allowed: 30 minutes


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


Exercise #1 AnswerCalculated quarterly requirements for XpertMTB/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


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


Exercise #2 AnswerCalculated quarterly requirements for XpertMTB/RIF testing


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


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

  • 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

  • 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

  • Cepheid/localdistributorwill prepare quotation

  • Customer pays in advance to qualify for reduced pricing [high burden developing countries (HBDC) pricing]


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

  • 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

  • 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

  • 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?


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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