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Module 4: Procurement and Inventory Management of Suppliesfor Xpert MTB/RIF
Global Laboratory Initiative – Xpert MTB/RIF Training Package
Global Laboratory InitiativeXpert MTB/RIF Training Package-2-
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
Learning Objectives
Global Laboratory InitiativeXpert MTB/RIF Training Package-3-
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
Contents of this module
Global Laboratory InitiativeXpert MTB/RIF Training Package-4-
Properly maintained and adequate supplies to ensure uninterrupted service and to minimize
waste
Supply management means… Supply management means…
Global Laboratory InitiativeXpert MTB/RIF Training Package-5-
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
Structure of a supply management system: National level
Global Laboratory InitiativeXpert MTB/RIF Training Package-6-
Describe supply management system(s) in your country
Supply management systemAdapt to country-specific system
Global Laboratory InitiativeXpert MTB/RIF Training Package-7-
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?
Ordering of Supplies
Always considerthe shelf-life of the ordered material, and your storage capacity under
appropriate conditions
Global Laboratory InitiativeXpert MTB/RIF Training Package-8-
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.
Supplies required for Xpert MTB/RIF:Provided by CepheidSupplies required for Xpert MTB/RIF:Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-9-
GeneXpertconfiguration
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-LNote: a 4 module instrument shell can be procured with only 1 or 2 modules, for later expansion
Supplies required for Xpert MTB/RIF:GeneXpert (Cepheid)Supplies required for Xpert MTB/RIF:GeneXpert (Cepheid)
Global Laboratory InitiativeXpert MTB/RIF Training Package-10-
Cepheid product Catalogue number
Number of tests
Xpert MTB/RIF Assay CGXMTB/RIF-50 50
Xpert MTB/RIF kit consists of reagents and
supplies sufficient for
50 tests
• 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)
Shelf life of open pouch: 6 weeks at 2–45oC
Supplies required for Xpert MTB/RIF:Provided by CepheidSupplies required for Xpert MTB/RIF:Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-11-
Cepheid product Catalogue number
Number of tests
Xpert Calibration Kit GXCALIB-100N-5 5Software,
package insert
5 Xpert Calibration Cartridges
Empty data CD
Supplies required for Xpert MTB/RIF:Provided by CepheidSupplies required for Xpert MTB/RIF:Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-12-
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 CepheidSupplies Required for Xpert MTB/RIF:NOT Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-13-
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:NOT Provided by CepheidSupplies Required for Xpert MTB/RIF:NOT Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-14-
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
Supplies Required for Xpert MTB/RIF: UPS
Global Laboratory InitiativeXpert MTB/RIF Training Package-15-
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: Generator
Global Laboratory InitiativeXpert MTB/RIF Training Package-16-
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: Inverter
Global Laboratory InitiativeXpert MTB/RIF Training Package-17-
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:Surge Protector
Global Laboratory InitiativeXpert MTB/RIF Training Package-18-
Biosafety supplies− Bio-hazard bags− 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
Global Laboratory InitiativeXpert MTB/RIF Training Package-19-
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)
Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-20-
Personal protective equipment− Laboratory coats− Gloves− Respirators (optional)
Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-21-
Stationery− Laboratory registers and request/report forms− Printing paper− Permanents markers− Pens (red and blue or black)− Write-on stickers (optional)
Supplies Required for Xpert MTB/RIF:NOT Provided by Cepheid
Global Laboratory InitiativeXpert MTB/RIF Training Package-22-
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 management
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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
Stock log book: required data
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Stock Log Book: Example
Physical count Requested Received Stock in hand
Signature
Units (No)
Date Units (No)
Date Units (No)
Date
Item name: ________________ Unit: ______________________
To be customized by each country
Global Laboratory InitiativeXpert MTB/RIF Training Package-25-
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
Perform a stock count
All items must be accounted for. Everything that
comes in and goes out must be recorded
Global Laboratory InitiativeXpert MTB/RIF Training Package-26-
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
Data required for calculating supplies
Global Laboratory InitiativeXpert MTB/RIF Training Package-27-
Items◦Sputum containers◦Xpert MTB/RIF kits◦Concentrated bleach solution◦Disposable Pasteur pipettes
Examples of items required
Global Laboratory InitiativeXpert MTB/RIF Training Package-28-
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region: Supply quarter:
District: Year:
Centre:
Total tests performed in previous quarter (A)= 600
Items
Quantity needed per test
(B)
Calculated requirements
for one quarter
(C) = AxB
Reserve quantity for one month
(D) = C/3
Stock on hand (E)
Calculated request
(F) = C+D-E
Actual request (rounded*)
Order unit**
Sputum containers (pieces)
1 100 Bag (1000 pieces)
Xpert MTB/RIF kits (50 tests per kit)
0.02 3 Box (50 tests)
Concentrated bleach solution (3%)***
0.003 litre
1.0 litre Bottle (1 liter)
Disposable Pasteur pipettes
1 150 Bag (1000 pieces)
Calculate quarterly requirement for Xpert MTB/RIF tests
* Or other time period
*
Adapt to country-specific system
Global Laboratory InitiativeXpert MTB/RIF Training Package-29-
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 1 piece
Quantities required for one Xpert MTB/RIF test (B)To be customized by each country
Global Laboratory InitiativeXpert MTB/RIF Training Package-30-
The value (A) equals the number of Xpert MTB/RIF tests performed during the previous quarter
Total number of tests performed in the previous quarter
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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
Calculation for one quarter of supply of an item (C)
Global Laboratory InitiativeXpert MTB/RIF Training Package-32-
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 one quarter of supplyof Xpert MTB/RIF cartridges (C)
Global Laboratory InitiativeXpert MTB/RIF Training Package-33-
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 reserve quantity (D) of Xpert MTB/RIF kits
Global Laboratory InitiativeXpert MTB/RIF Training Package-34-
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 Xpert MTB/RIF supply, stock on hand (E)
Global Laboratory InitiativeXpert MTB/RIF Training Package-35-
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)
Example 1: to calculate required quantity (F) of Xpert MTB/RIF kits
Global Laboratory InitiativeXpert MTB/RIF Training Package-36-
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 1: to calculate requested / issued quantities of Xpert MTB/RIF kits
Global Laboratory InitiativeXpert MTB/RIF Training Package-37-
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 one quarter of supplyof bleach solution (C)
Global Laboratory InitiativeXpert MTB/RIF Training Package-38-
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)
Example 2: to calculate reserve quantity (D) of bleach solutionAdapt to local setting and supplies’ shelf life
Global Laboratory InitiativeXpert MTB/RIF Training Package-39-
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
Example 2: to calculate supply of bleach, stock on hand (E)
Global Laboratory InitiativeXpert MTB/RIF Training Package-40-
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) + 300 ml (D) – 400 ml (E) = 800 ml (F)
Example 2: to calculate quantity (F) of bleach solution to order
Global Laboratory InitiativeXpert MTB/RIF Training Package-41-
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
Example 2: to calculate quantities of bleach solution to request/issue
Global Laboratory InitiativeXpert MTB/RIF Training Package-42-
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
Global Laboratory InitiativeXpert MTB/RIF Training Package-43-
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region: Supply quarter:
District: Year:
Centre:
Total tests performed in previous quarter (A)= 600
Items
Quantity needed per test
(B)
Calculated requirements
for one quarter
(C) = AxB
Reserve quantity for one month
(D) = C/3
Stock on hand (E)
Calculated request
(F) = C+D-E
Actual request (rounded*)
Order unit**
Sputum containers (pieces)
1 100 Bag (1000 pieces)
Xpert MTB/RIF kits (50 tests per kit)
0.02 15 Box (50 tests)
Concentrated bleach solution (3%)***
0.003 litre
1.0 litre Bottle (1 liter)
Disposable Pasteur pipettes
1 150 Bag (1000 pieces)
Exercise #1: Calculate quarterly requirements for Xpert MTB/RIF testing
Global Laboratory InitiativeXpert MTB/RIF Training Package-44-
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region: Supply quarter:
District: Year:
Centre:
Total tests performed in previous quarter (A)= 600
Items
Quantity needed per test
(B)
Calculated requirements
for one quarter
(C) = AxB
Reserve quantity for one month
(D) = C/3
Stock on hand (E)
Calculated request
(F) = C+D-E
Actual request (rounded*)
Order unit**
Sputum containers (pieces)
1 600 200 100 700 1 Bag (1000) Bag (1000 pieces)
Xpert MTB/RIF kits (50 tests per kit)
0.02 12 4 15 1 1 box (50 tests) Box (50 tests)
Concentrated bleach solution (3%)***
0.003 litre
1.8 litre 0.6 litre 1.0 litre 1.4 litre 2 Bottles (2 litre) Bottle (1 liter)
Disposable Pasteur pipettes
1 600 200 150 650 1 Bag (1000) Bag (1000 pieces)
Exercise #1 AnswerCalculated quarterly requirements for Xpert MTB/RIF testing
Global Laboratory InitiativeXpert MTB/RIF Training Package-45-
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
Global Laboratory InitiativeXpert MTB/RIF Training Package-46-
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region: Supply quarter:
District: Year:
Centre:
Total tests performed in previous quarter (A)= 1200
Items
Quantity needed per test
(B)
Calculated requirements
for one quarter
(C) = AxB
Reserve quantity for one month
(D) = C/3
Stock on hand (E)
Calculated request
(F) = C+D-E
Actual request (rounded*)
Order unit**
Sputum containers (pieces)
1 150 Bag (1000 pieces)
Xpert MTB/RIF kits (50 tests per kit)
0.02 3 Box (50 tests)
Concentrated bleach solution (3%)***
0.003 litre
2.0 litre Bottle (1 liter)
Disposable Pasteur pipettes
1 120 Bag (1000 pieces)
Exercise #2: calculate quarterly requirements for Xpert MTB/RIF testing
Global Laboratory InitiativeXpert MTB/RIF Training Package-47-
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region: Supply quarter:
District: Year:
Centre:
Total tests performed in previous quarter (A)= 1200
Items
Quantity needed per test
(B)
Calculated requirements
for one quarter
(C) = AxB
Reserve quantity for one month
(D) = C/3
Stock on hand (E)
Calculated request
(F) = C+D-E
Actual request (rounded*)
Order unit**
Sputum containers (pieces)
1 1200 400 150 1450 2 Bags Bag (1000 pieces)
Xpert MTB/RIF kits (50 tests per kit)
0.02 24 8 3 29 29 boxes Box (50 tests)
Concentrated bleach solution (3%)***
0.003 litre
3.6 litre 1.2 litre 2.0 litre 2.8 litre 3 bottles Bottle (1 liter)
Disposable Pasteur pipettes
1 1200 400 120 1480 2 Bags Bag (1000 pieces)
Exercise #2 AnswerCalculated quarterly requirements for Xpert MTB/RIF testing
Global Laboratory InitiativeXpert MTB/RIF Training Package-48-
Procedure for placement orders depends on a source of funding
Discuss local procurement procedures and contigency plan in case of shortages of supplies
Placing orders Adapt to country-specific system
Global Laboratory InitiativeXpert MTB/RIF Training Package-49-
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
Options for procurement of GeneXpert instruments and cartridges
Global Laboratory InitiativeXpert MTB/RIF Training Package-50-
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
Prior to placing an order
Global Laboratory InitiativeXpert MTB/RIF Training Package-51-
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
Information needed to place an order
Global Laboratory InitiativeXpert MTB/RIF Training Package-52-
Cepheid/local distributor will prepare quotation Customer pays in advance to qualify for reduced pricing
[high burden developing countries (HBDC) pricing]
After placing an order
Global Laboratory InitiativeXpert MTB/RIF Training Package-53-
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
Upon receipt
Global Laboratory InitiativeXpert MTB/RIF Training Package-54-
Keep in a clean, dry, well-ventilated, and organized storage area
Xpert MTB/RIF kits must be kept at 2-28C Store away from direct sunlight Organize existing and new shipments by expiry date
(supplies with the soonest expiry date must be used first)
Proper storage of inventory
Global Laboratory InitiativeXpert MTB/RIF Training Package-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
Global Laboratory InitiativeXpert MTB/RIF Training Package-56-
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?
Assessment