Module 4:
Procurement and Inventory
Management of Supplies
for Xpert MTB/RIF
Global Laboratory Initiative – Xpert MTB/RIF Training Package
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
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Global Laboratory Initiative
Xpert MTB/RIF Training Package

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
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Global Laboratory Initiative
Xpert MTB/RIF Training Package
Supply management means…
Properly maintained and adequate supplies to ensure
uninterrupted service and to minimize waste
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Global Laboratory Initiative
Xpert MTB/RIF Training Package

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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
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Adapt to country-specific system
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Describe supply management system(s) in your country
Global Laboratory Initiative
Xpert MTB/RIF Training Package

What to order?
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From where?
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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?
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Always consider
the shelf-life of the
ordered material, and
your storage capacity
under appropriate
conditions
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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.
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Global Laboratory Initiative
Xpert MTB/RIF Training Package
GeneXpert
configuration
Catalogue number
With desktop
computer
GXI-1-D
With laptop
GeneXpert 2
module
GXII-2-D
GXII-2-L
GeneXpert 4
module
GXIV-4-D
GXIV-4-L
GXXVI-16-D
GXXVI-16-L
GeneXpert 1
module
GeneXpert 16
module
GXI-1-L
Note: a 4 module instrument shell can be procured with only 1 or 2 modules, for later expansion
-9-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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)
-10-
Xpert MTB/RIF
kit consists of
reagents and
supplies
sufficient for
50 tests
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Cepheid product
Catalogue number
Number of tests
Xpert Calibration Kit
GXCALIB-100N-5
5
Software,
package insert
Empty data CD
5 Xpert Calibration Cartridges
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Global Laboratory Initiative
Xpert MTB/RIF Training Package
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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.
Global Laboratory Initiative
Xpert MTB/RIF Training Package

Equipment
− Power supply backup as needed (UPS and
batteries, generator, inverter, surge protector)
− Printer and printing cartridges
− Timer
− Thermometer
− Vortex (optional)
-13-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Critical parameters
Comment
Suitable
Specifications
Voltage in your country
Voltage of utility power
supply
Depends on a
country
UPS capacity in kilovolt- Depends on equipment
ampere (VA)
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
-14-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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
-15-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

Converts low-volt power into a high-volt power
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Can run on car batteries
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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)
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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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
Global Laboratory Initiative
Xpert 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)
Global Laboratory Initiative
Xpert 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)
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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Personal protective equipment
− Laboratory coats
− Gloves
− Respirators (optional)
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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Stationery
− Laboratory registers and request/report forms
− Printing paper
− Permanents markers
− Pens (red and blue or black)
− Write-on stickers (optional)
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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
-22-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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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
Global Laboratory Initiative
Xpert MTB/RIF Training Package
To be customized by each country
Item name: ________________ Unit: ______________________
Physical count
Units
(No)
-24-
Date
Requested
Units
(No)
Date
Received
Units
(No)
Date
Stock
in
hand
Signature
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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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
-25-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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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
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Global Laboratory Initiative
Xpert MTB/RIF Training Package

Items
◦
◦
◦
◦
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Sputum containers
Xpert MTB/RIF kits
Concentrated bleach solution
Disposable Pasteur pipettes
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Adapt to country-specific system
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region:
Supply quarter:
District:
Year:
Centre:
Total tests performed in previous quarter (A)= 600
Items
Sputum containers
(pieces)
Xpert MTB/RIF kits (50
tests per kit)
Concentrated bleach
solution (3%)***
Disposable Pasteur
pipettes
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**
1
100
Bag (1000 pieces)
0.02
3
Box (50 tests)
0.003
litre
1.0 litre
Bottle (1 liter)
1
150
Bag (1000 pieces)
* Or other time period
-28-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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
1.5 ml (average of 100ml per day
(Example: 3%- note: the standard for 10 tests, diluted 6 times with
concentration varies from country water; final concentration 0.5% of
to country)
sodium hypochlorite)
Disposable Pasteur pipettes, 3ml
1 piece
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Global Laboratory Initiative
Xpert MTB/RIF Training Package
The value (A) equals the number of Xpert MTB/RIF tests
performed during the previous quarter
-30-
Global Laboratory Initiative
Xpert MTB/RIF Training Package


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:
AxB=C
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Global Laboratory Initiative
Xpert MTB/RIF Training Package


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)?

AxB=C

600 tests x 0.02 kit/test = 12 kits
-32-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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)
-33-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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
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Global Laboratory Initiative
Xpert MTB/RIF Training Package

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)
-35-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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-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)
Global Laboratory Initiative
Xpert MTB/RIF Training Package


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)?

AxB=C

600 tests x 1.5 ml/test = 900 ml
-37-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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)
-38-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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
-39-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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)
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Global Laboratory Initiative
Xpert MTB/RIF Training Package
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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
Global Laboratory Initiative
Xpert MTB/RIF Training Package

Use worksheet labeled exercise #1

Work individually

Use sample data provided

Time allowed: 30 minutes
-42-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region:
Supply quarter:
District:
Year:
Centre:
Total tests performed in previous quarter (A)= 600
Items
Sputum containers
(pieces)
Xpert MTB/RIF kits (50
tests per kit)
Concentrated bleach
solution (3%)***
Disposable Pasteur
pipettes
-43-
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**
1
100
Bag (1000 pieces)
0.02
15
Box (50 tests)
0.003
litre
1.0 litre
Bottle (1 liter)
1
150
Bag (1000 pieces)
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region:
Supply quarter:
District:
Year:
Centre:
Total tests performed in previous quarter (A)= 600
Items
Sputum containers
(pieces)
Xpert MTB/RIF kits (50
tests per kit)
Concentrated bleach
solution (3%)***
Disposable Pasteur
pipettes
-44-
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**
1
600
200
100
700
1 Bag (1000)
Bag (1000 pieces)
0.02
12
4
15
1
1 box (50 tests)
Box (50 tests)
0.003
litre
1.8 litre
0.6 litre
1.0 litre
1.4 litre
2 Bottles (2 litre)
Bottle (1 liter)
1
600
200
150
650
1 Bag (1000)
Bag (1000 pieces)
Global Laboratory Initiative
Xpert MTB/RIF Training Package

Use worksheet labeled exercise #2

Work individually

Use sample data provided

Time allowed: 30 minutes
-45-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region:
Supply quarter:
District:
Year:
Centre:
Total tests performed in previous quarter (A)= 1200
Items
Sputum containers
(pieces)
Xpert MTB/RIF kits (50
tests per kit)
Concentrated bleach
solution (3%)***
Disposable Pasteur
pipettes
-46-
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**
1
150
Bag (1000 pieces)
0.02
3
Box (50 tests)
0.003
litre
2.0 litre
Bottle (1 liter)
1
120
Bag (1000 pieces)
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Quarterly Supply Requirements for a Xpert MTB/RIF testing
Region:
Supply quarter:
District:
Year:
Centre:
Total tests performed in previous quarter (A)= 1200
Items
Sputum containers
(pieces)
Xpert MTB/RIF kits (50
tests per kit)
Concentrated bleach
solution (3%)***
Disposable Pasteur
pipettes
-47-
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**
1
1200
400
150
1450
2 Bags
Bag (1000 pieces)
0.02
24
8
3
29
29 boxes
Box (50 tests)
0.003
litre
3.6 litre
1.2 litre
2.0 litre
2.8 litre
3 bottles
Bottle (1 liter)
1
1200
400
120
1480
2 Bags
Bag (1000 pieces)
Global Laboratory Initiative
Xpert MTB/RIF Training Package
Adapt to country-specific system

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-48-
Procedure for placement orders depends on a source of
funding
Discuss local procurement procedures and contigency
plan in case of shortages of supplies
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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-49-
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
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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-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/success
es/find-negotiated-prices/xpert_mtb_rif.html
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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-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
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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-52-
Cepheid/local distributor will prepare quotation
Customer pays in advance to qualify for reduced pricing
[high burden developing countries (HBDC) pricing]
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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
-53-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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)
-54-
Global Laboratory Initiative
Xpert MTB/RIF Training Package

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-55-
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 Initiative
Xpert MTB/RIF Training Package

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?
-56-
Global Laboratory Initiative
Xpert MTB/RIF Training Package
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.