module 4: procurement and inventory management of supplies for xpert mtb/rif global laboratory...

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


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


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

waste

Supply management means… Supply management means…


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


Describe supply management system(s) in your country

Supply management systemAdapt to country-specific system


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


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


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)


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



Cepheid product Catalogue number

Number of tests

Xpert Calibration Kit GXCALIB-100N-5 5Software,

package insert

5 Xpert Calibration Cartridges

Empty data CD



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


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


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


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


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


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


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


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)



Personal protective equipment− Laboratory coats− Gloves− Respirators (optional)



Stationery− Laboratory registers and request/report forms− Printing paper− Permanents markers− Pens (red and blue or black)− Write-on stickers (optional)



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


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


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


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


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


Items◦Sputum containers◦Xpert MTB/RIF kits◦Concentrated bleach solution◦Disposable Pasteur pipettes

Examples of items required


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


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


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


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)


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)


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


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)


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


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


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)


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


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)


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


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


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




District: Year:

Centre:


Items


(B)


for one quarter

(C) = AxB


(D) = C/3

Stock on hand (E)

Calculated request

(F) = C+D-E


Order unit**


1 100 Bag (1000 pieces)


0.02 15 Box (50 tests)


0.003 litre



1 150 Bag (1000 pieces)





District: Year:

Centre:


Items


(B)


for one quarter

(C) = AxB


(D) = C/3

Stock on hand (E)

Calculated request

(F) = C+D-E


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)

Exercise #1 AnswerCalculated quarterly requirements for Xpert MTB/RIF testing


Use worksheet labeled exercise #2 Work individually Use sample data provided Time allowed: 30 minutes





District: Year:

Centre:


Items


(B)


for one quarter

(C) = AxB


(D) = C/3

Stock on hand (E)

Calculated request

(F) = C+D-E


Order unit**


1 150 Bag (1000 pieces)


0.02 3 Box (50 tests)


0.003 litre



1 120 Bag (1000 pieces)

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




District: Year:

Centre:


Items


(B)


for one quarter

(C) = AxB


(D) = C/3

Stock on hand (E)

Calculated request

(F) = C+D-E


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)

Exercise #2 AnswerCalculated quarterly requirements for Xpert MTB/RIF testing


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


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


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

http://www.finddiagnostics.org/about/what_we_do/successes/find-negotiated-prices/xpert_mtb_rif.html

http://www.finddiagnostics.org/about/what_we_do/successes/find-negotiated-prices/xpert_mtb_rif.html


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


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


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


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


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


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

module 4: procurement and inventory management of supplies for xpert mtb/rif global laboratory...

Documents

xpert mtbrif record

xpert calibration cartridges

shelf life of supplies

maintenance slide

adequate supplies

module genexpert

countryspecific system

data cd slide