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Page 1: accine - NIHFW - 3.pdf · • Use case studies for successful marketing/ service delivery e.g. dabba walas, cooperative milk societies (amul/pulse polio). Talk about reliability,
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Module 3 - Vaccine and Logistics Management | 1

Vaccine and Logistics management

Health Managers Modules for Immunization

Compiled by NIPI-UNOPS and NCHRC-NIHFW, Delhi, India For Child health managers/Block program managers under NRHM.

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Module 3 - Vaccine and Logistics Management | 3

ForewordThe Universal Immunization Program, launched in 1985 for reducing deaths and disabilities due to vaccine preventable diseases in the country, has received a special impetus through the National Rural Health Mission (NRHM). The strengthening support provided by NRHM includes funds, resources, strategic guidelines and contractual manpower for program management. Since 2005, when the NRHM came into effect, there has been an increasing trend in Immunization coverage and quality.

Child Health managers introduced to manage and oversee child health and immunization in select districts of low performing states, as well as other health managers from non-medical background introduced through the NRHM, was found to have an increasing role in the Immunization Program. However they often came with no prior knowledge, experience or skills related to management of the Immunization program. Their roles and therefore their requirement in the program were identified as being a mixture of technical, supervisory and managerial. This set of modules covers many of these aspects, and have been developed for self as well as collective learning by program managers and supervisors.

The modules have been compiled from existing literature related to the Immunization program and health management available in India with the Ministry of Health and Family Welfare as well as with UNICEF, WHO, USAID and PATH. The materials have been adapted to meet the requirements at the primary levels of health program management in the country, particularly at the sector, block and district levels.

The National Child Health Resource Center (NCHRC) at the National institute of Health and Family Welfare (NIHFW) has worked closely with national trainers in Immunization at the NIHFW and the Immunization officer of United Nations Office for Project Services, Norway India Partnership Initiative (UNOPS-NIPI) in developing these modules. The pilot testing of these modules has been conducted in Orissa, Bihar and Rajasthan involving the district, block and sub block level managers and supervisors along with select state level trainers, and their feedback has been incorporated. UNOPS-NIPI has been instrumental in identifying the need for improving program management at implementation levels as an important step to achieve enhanced program coverage and quality, and have also provided the required support for the development of these modules.

We hope that this set of module will prove to be useful in enhancing the capacity of managers and supervisors at implementation levels for improving quality and coverage of lmmunization.

Dr. Kaliprasad Pappu Prof. Jayant K. DasDirector, Director,UNOPS-NIPI LFA National Institute of Health and Family welfareNew Delhi New Delhi

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Module 3 - Vaccine and Logistics Management | 5

Table of Contents Abbreviation .......................................................................................................................................................................7

I. Case studies of Logistics management.................................................................................................................. 11

II. Key principals and processes ..................................................................................................................................... 15

III. Key components ............................................................................................................................................................ 19

A. Personnel .......................................................................................................................................................................... 20

B. Materials ............................................................................................................................................................................ 21

C. Space ................................................................................................................................................................................. 23

D. Equipment ........................................................................................................................................................................ 24

E. Temperature monitoring ............................................................................................................................................ 30

F. Transport ........................................................................................................................................................................... 35

G. Stocks ................................................................................................................................................................................. 36

H. Tools .................................................................................................................................................................................... 39

I. Waste disposal ................................................................................................................................................................ 40

J. Emergency management ........................................................................................................................................... 41

Final Assessment ............................................................................................................................................................ 45

References ........................................................................................................................................................................ 51

Facilitators Guide ........................................................................................................................................................... 53

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Module 3 - Vaccine and Logistics Management | 7

Abbreviations

Abbreviation Extended form

ADS Auto Disable Syringes

AMC Average monthly consumption

ANM Auxiliary Nurse Midwife

ART Antiretroviral Therapy

ASHA Accredited Social Health Activist

AVD Alternate Vaccine Delivery

BCG Bacillus Calmette-Guérin

BCHM Block Child Health Manger

BMO Block Medical Officer

BPM Block Program Manager

CCH Cold Chain Handler

CFC Chloro fluoro carbons

CHC Community Health Center

CPCB Central Pollution Control Board

DCHM District Child Health Officer

DF Deep Freezers

DIO District Immunization Officers

DPM District Program Manager

DPT Diphtheria Pertussis Tetanus Vaccine

DT Diphtheria Tetanus

DTaP Diphtheria Tetanus acelullar Pertussis Vaccine

EEFO Early expiry first out

FIFO First In First Out

Hep B Hepatitis B

ICDS Integrated Childhood Development Services

IFA Iron and Folic Acid Tablet

ILR Ice-Lined Refrigerator

MCV Measles containing Vaccine

MOHFW Ministry of Health and Family Welfare

MOIC Medical Officer in Charge

NRHM National Rural Health Mission

NVBDCP National Vector Borne Disease Control Program

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8 | Health managers’ modules on Immunization

Abbreviation Extended form

OPV Oral Polio Vaccine

PHC Primary Health Center

PIP Program Implementation Plan

POL Petrol/diesel/ oil/lubrication

RCH Reproductive and Child Health

RCHO Reproductive and child health Officer

RKS Rogi Kalyan Samiti

RNTCP Revised National Tuberculosis Control Program

TT Tetanus Toxoid Vaccine

UIP Universal Immunization Programme

VVM Vaccine Vial Monitor

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Module 3 - Vaccine and Logistics Management | 9

Objectives of this module• For the manager to be able to understand the requisites of proper vaccine handling and its

importance.

• For the manager to ensure human resources are trained/ responsible and able to manage vaccines.

• For the manager to identify and if need be to develop mechanisms to monitor quality/quantity/ stocks/ equipment/use and waste disposal.

• To ensure the manager manages logistics supply so that adequate stocks are available at all times in all cold chain stores, any stock outs are prevented and vaccine wastage is minimized

• To ensure the manager is prepared to handle any emergencies related to logistics management and cold chain

Contents:I. Case studies of Logistics management

II. Key principals and processes

III. Key components

A. Personnel

B. Materials

C. Space

D. Equipment

E. Temperature monitoring

F. Transport

G. Stocks

H. Tools

I. Waste disposal

J. Emergency management

Health managers’ modules for ImmunizationModule 3: Vaccine and Logistics Management

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Module 3 - Vaccine and Logistics Management | 11

1. Why is it important to ensure good uninterrupted services and availability of commodities in Public health?

• Use case studies for successful marketing/ service delivery e.g. dabba walas, cooperative milk societies (amul/pulse polio). Talk about reliability, consistency, “hot” meals and “cold milk” (temp maintenance), reach, weather resistance!

• Discuss other services and supplies which involve the distribution of large amounts of commodities under strict temperature regulated conditions; find out if there are other successful models of supply chain management.

(A) Amul Milk

Amul has a wide distribution network comprising 2,12 million farmers producing almost 450 000 litres of milk collected daily to produce dairy products worth Rs.6 crore. The products are then distributed to 5 Lakhs retailers across India. Milk being a fresh product requires an efficient distribution system, and faced with poor infrastructure and far distances Amul established a strategy to ensure fresh milk products reaching Indians all across.

In achieving this Amul identified two main requirements:

Firstly, for sustainability they needed to understand the market and forces of supply and demand. Secondly they required professional managers and technocrats to ensure manage effectively the large network and the commercial viability.

The population demanded modest consumption of dairy products and Amul adopted a low cost price strategy of affordable, value for money products, to attract a large base of consumers.

At present Amul has a distribution network with 3500 distributors providing 5 lakh retailers with Amul products. To buffer inventory there are 47 depots with dry and cold warehouses keeping stock of all the products.

Wholesale dealers will carry inventory from the warehouse to the retailers.

Amul was established as a cooperative to bring together and strengthen the farmers, but for managing the wide distribution network Amul placed professional managers and technocrats to ensure viability of the business operations.

Amuls core activity is milk processing and production of dairy products. Gujarat Coorporative Milkmans Federation (GCMMF) was incharge of marketing and brand development. The logistics of milk collection, distribution of products, sale through dealers and retailers, veterinary services etc was entrusted to third parties, many of which are not in the organized sector.

Amuls federation and unions has developed and adapted successful models from around the world. An example is that every Friday all employees meet in their nearest branch office to discuss quality concerns and other issues. Adopting best practice activities and quality circles across the various levels of the organization has helped ensure the success of Amul.

I. Case studies

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12 | Health managers’ modules on Immunization

(B) Mumbai’s tiffinwalas

Every morning 2 lakh households in Mumbai rely on 5000 tiffinwallas to collect and distribute the tiffinboxes to their familymember working in the offices in the city.

Every morning the tiffinwalla comes to collect the lunchmeal, freshly cooked at home, and rushes to travel the distance from the suburbs to the offices before lunchtime. The priority is to deliver on time.

The tiffinwallas charge Rs. 200 per month for daily distribution. A tiffinwalla collects lunchboxes from various households and will make around Rs. 4000 per month.

Punctuality is key and it’s very important that the distribution system works smoothly to ensure the reliability of the service. “If we are late with the lunchboxes then office workers don’t get their lunch, and we lose money. By lunchtime everyone should have their tiffin.”

From collection in the households, the tiffinwallas manage the 200,000 lunchboxes; through trains, balancing the boxes on their heads through the narrow lanes and heavy traffic of the city. Once the boxes from the suburbs reach into the city, the sorting procedure takes place. This process has made the tiffinwallas successful and a world famous best practice case study.

Given that many of the distributors are illiterate the system works with color-codes and numbers, denoting where the boxes has to go. The tiffinwallas claim to make less than one mistake per 60 lakhs deliveries.

Business schools and companies have studied their system and tiffinwallas have even given lectures on how firms can copy their system.

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Module 3 - Vaccine and Logistics Management | 13

2. However what is the situation actually like in regard to vaccine supply chain management?

Look at the pictures, what do they tell you? Can these situations be avoided?

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Module 3 - Vaccine and Logistics Management | 15II. Key Principals and processes in cold chain and vaccine management

1. The 5 rights

As a managers you would have to remember the five rights of logistics management:

• Right materials: Required vaccines, diluents, syringes, vitamins, medicines, equipment, material for communication

• Right quantities: requisite amounts so that no beneficiary is turned away.

• Right quality: within expiry date, correct vaccine vial monitor, no frozen freeze sensitive vaccines.

• Right place: as decided in the micro plan, socially acceptable site, accessible to all beneficiaries.

• Right time: at a time suitable for both service provider and beneficiary.

To reach the end result of all the 5 R’s, careful and stringent planning and execution is required right from the place and time of procuring and ordering commodities to storing and stocking it to its final distribution and utilization.

2. The Logistics cycle:

As a manager the end result of your work should be that all sessions are held with all needed materials. However you would also have to ensure materials are regularly ordered, properly stored and appropriately distributed. This is called a Logistics Cycle.

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16 | Health managers’ modules on Immunization

The health manager would have an important role in ensuring all processes required for ensuring regularity of supplies and services related to child health at beneficiary level.

This process would begin from ordering supplies (also called indenting) from the next higher level (in case of block then the next higher level would be the district). Most of the supplies would be available in the district but sometimes, the block may have to procure certain supplies in case of non-availability or directions for direct procurement by the health administration. However the most important activity would be to calculate the correct requirement of each material as well as understand the supply cycles.

As materials would remain at the block health facility until they are distributed further or used, the manager has to keep a keen eye on the materials while they are stocked and stored at the facility itself including storage conditions, practices, space and volume constraints and issues as well as functioning and repairs of equipment for storage.

The final aspect of logistics management that has to be overseen is during the distribution to the out-reach areas and utilization at the beneficiary level.

3. The cold chain

Cold chain is a system of storing and transporting vaccines at recommended temperature range, from the point of manufacture to the point of use.

This system is based on the fact that vaccines are sensitive to changes in temperature, which may

result in changing their potency and effectiveness. Different vaccines have different sensitivities to freezing and high temperatures. However the temperature range of 2-8 degrees Celsius is safe to transport and store several vaccines together.

A variety of equipments are available to ensure this temperature range is maintained during vaccine storage and transportation, but along with the equipments it is also important to ensure that correct practices are followed.

4. Temperature and light sensitive vaccines

What are the recommended temperatures for storing and transporting different vaccines?

As vaccines have different sensitivities to heat, cold and even light it is important to know the different vaccines and their sensitivities.

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Module 3 - Vaccine and Logistics Management | 17

Vaccine Sensitivities

1. To freezing:

That is, vaccines such as Hepatitis B, DPT and TT should never be kept in sub zero temperatures and if

FROZEN they will be PERMANENTLY DAMAGED. Whereas Measles and OPV can be stored if required, in freezing / very cold conditions.

2. To elevated temperatures

Vaccines such as BCG, OPV and measles should not be left out in high temperatures for long.

Following re constitution BCG & Measles vaccination should be used within 4 hours.

3. To light;

and as such are packaged in amber colored vials

a. BCG

b. Measles

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Module 3 - Vaccine and Logistics Management | 19

Logistics management for child health programs dealing both with vaccines which require cold chain and other supplies which do not is a complex process which involves the following components.

a) Personnel b) Materials

c) Space d) Equipment

e) Temperature monitoring f ) Transport

g) Stocks h) Procedures

i) Tools j) Waste disposal

District Block Sector FieldPersonnel RCHO/DIO, DPM/

DCHM, Storekeeper/ Pharmacist, CCH

MOIC, BPM/BCHM,

Storekeeper/Pharmacist, CCH

CCH, AVD AVD, ANM/health worker

Space Cold chain rooms,

Dry storage areas/rooms,

Space for packing, parking, loading, unloading.

Easy access.

Space for back-up gensets

Cold chain room, dry storage space, space for distribution

Cold chain area, dry storage area, space for distribution

Cool shaded areas, preferably indoors.

Equipment ILR, DF, stabilizers, gen sets, cold boxes, ice packs. Thermometers,

ILR, DF, stabilizers, gen sets, cold boxes, ice packs, vaccine carrier. Thermometers

ILR, DF, stabilizers, gen sets, cold boxes, ice packs, vaccine carriers. Thermometers

ice packs, vaccine carriers

Transport Vaccine vans. Vehicle for vaccine procurement

Vehicle for vaccine distribution/ alternate vaccine delivery

Arrangements for additional outreach sites/ mobile areas

Stocks 3 months

Cold chain room, dry storage space

1 month

Cold chain room, dry storage space

1 month

Cold chain area, dry storage area/racks

1 day

Dry, cool area

Procedures Indent, receipt, storage, distribution, emergency plans

Indent, receipt, storage, distribution, waste disposal, emergency plans

Indent, receipt, storage, distribution, waste disposal, emergency plans

Indent, receipt, utilization, return, back up supplies.

Tools VVM, Registers, white boards, software, job aids,

Temperature devices

VVM, Registers, white boards, software, job aids,

Temperature devices

VVM, Registers, white boards, software, job aids,

Temperature devices

VVM, reconstitution time.

III: Key components of cold chain and vaccine management

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20 | Health managers’ modules on Immunization

A. Personnel: describe their roles in logistics management

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Module 3 - Vaccine and Logistics Management | 21

B. Materials: what is needed

The following table contains a list of materials needed at health sub center and for outreach activities during health and nutrition days.

Material details Related intervention Supply sourceIron and Folic acid tablet (large) Ante natal care RCH Kit A

Folic acid tablet Antenatal care RCH Kit A

Adult Weighing machine Antenatal care State supply*

Blood pressure apparatus Antenatal care State supply*

Stethoscope Antenatal care State supply*

Haemoglobinometer/colour strip Antenatal care State supply*

Uristix (protein)/Diastix (sugar) Antenatal care State supply*

Tetanus Toxoid injection Antenatal care UIP supply

Pregnancy testing kit (Nischay) Antenatal care Selected supply in some districts

Oral Rehydration salt Child health RCH Kit A

Cotrimoxazole tablet Child health RCH Kit A

IFA Tablet (small) Child health RCH Kit A

IFA syrup Child health RCH Kit A

Zinc sulphate tablets Child health RCH Kit A

Vitamin A syrup Child health RCH Kit A

Albendazole tablet Child health RCH Kit B

Infant/child weighing machine Child health State supply*/ ICDS

Clinical thermometer Child health State supply*

BCG vaccine and diluent Child health (vaccination) UIP supply

DPT vaccine Child health (vaccination) UIP supply

Hepatitis B vaccine Child health (vaccination) UIP supply

Measles vaccine and diluent Child health (vaccination) UIP supply

Oral Polio Vaccine (trivalent) with dropper Child health (vaccination) UIP supply

AD syringes and disposal syringes Child health (vaccination) UIP supply

Hub cutter Child health (vaccination) UIP supply#

Red and black plastic bags Child health (vaccination) UIP supply#

Pouch with zipper for vaccines Child health (vaccination) UIP supply#

Paracetamol tablets General health RCH Kit B

Chloramphenicol eye ointment General health RCH Kit B

Povidone Iodine Ointment General health RCH Kit B

Cotton Bandage General health RCH Kit B

Adsorbent cotton General health RCH Kit B

Gentian Violet crystals General health RCH Kit A

Soap and soap dish General health Local arrangement

Growth monitoring charts Nutrition ICDS

Supplementary foods Nutrition ICDS

Methyle ergometrine tablet Maternal health RCH Kit B

Methyle ergometrine injection Maternal health RCH Kit B

Dicyclomine hydrochloride Tablet Maternal health RCH Kit B

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22 | Health managers’ modules on Immunization

Material details Related intervention Supply sourceCondoms (Nirodh) Family planning RCH supply

Oral Contraceptive pills Family planning RCH supply

Intrauterine devices Family planning RCH supply

Anti malarial drugs /falaria / KA drugs Communicable diseases NVBDCP

Tuberculosis treatment kits Communicable diseases RNTCP

Multidrug kits Communicable diseases Leprosy program

ART Communicable diseases State AIDS control society

Records, reports and registers HMIS State supply*

Flipcharts, posters and IEC material Health education and awareness

State supply*

As you can see the list of materials above is quite extensive and there are a variety of supply channels before they reach the point of use. However, apart from vaccines, other material need only clean, organized dry space for storing. In fact as soon as these materials arrive at block or Primary health centers, their details need to be recorded then sent to the health sub center level (except the quantities that are needed at the PHC/CHC itself ). Vaccines however, need cold chain and are to be stored only at points where there is a functional Ice lined refrigerator and reliable electricity supply.

The several sources of supply also need to be kept in mind by the manager, including the frequency of supply and expiry dates of the materials. The state supply systems vary from state to state as while some states procure the material at a central point, others send instructions and funds for procurement at more peripheral levels. Whatever be the procedure, it would help the health manger to get a copy of the instructions, specifications and financial guidelines of materials that are to be locally procured.

While vaccines and syringes are supplied through the Universal Immunization Program by the MOHFW, Government of India, funds have been separately provided under part C of PIP for procurement of items# like plastic pouches, bags and hub cutter (formerly central supply but some states at procuring at state level) needed for the immunization activities.

Coordination also is needed for other materials that are supplied through other mechanisms like the ICDS and communicable diseases control programs.

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Module 3 - Vaccine and Logistics Management | 23

Criteria To have *WHO/V&B/02.34 Not to haveLocation Within the health facility campus; in a room

with no direct exposure to sunlight, covered from all sides with a secure door which can be closed if required.

Preferably centrally located to all distribution points.

Separate from the health facility campus.

In a room exposed directly to sunshine or nature.

Open and exposed on one or multiple sides.

Location on any extreme corner of the entire distribution area.

Access Preferably to all weather roads, allow easy access till door to the largest vehicle to be used.

Areas which flood or are cut off in certain seasons

Size Large enough to accommodate all cold chain equipment, have additional dry storage space, adequate space for loading and distribution, additional space for a few desks and chairs

Provide a minimum of 4.5 m3 of room volume per 100 litres of vaccine stored.

Small areas between rooms or verandahs, or scattered areas where different equipment, dry commodities and staff areas are placed.

Electrical fittings

All wirings carried out by a qualified electrician

All circuits having sufficient earth protection

The power leads of appliances not longer than necessary

Refrigerators and freezers should be wired directly to stabilizers which in turn should have direct wiring into wall units

Poor quality wiring

Using plugs and sockets of improper quality

Circuits having inadequate or lack of earth protection

coiled or loose cables/wires

No connection of stabilizers with equipment

Loose wires put into electrical sockets.

Space between equipment and walls

ILRs and deep freezers should be spaced 10 cms from walls and 10 cms away from other equipment

Equipment too close to or touching walls /each other.

Flooring Level floors preferably with a concrete slab beneath

Titled or broken floors

Mount units or pallets

ILRs and freezers should be mounted about 10 cm clear of the floor on their own wooden pallets, stands or blocks. This prevents corrosion when water is swept under units during floor cleaning

Direct placement of electrical cold chain equipment on the floors

C. Storage space

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24 | Health managers’ modules on Immunization

D. Equipment

1. The Ice lined refrigerator (ILR):

Use and temperature: This is the most important equipment for storing vaccines in peripheral stores. In fact, below district level all vaccines are recommended to be stored in the ice-lined refrigerator. This is so because the machine has a lining of ice-packs around it which ensures temperature range of 2-8 degrees Celsius within the cabinet, and a running ILR can maintain this temperature for more than 18 hours when there is disruption of electricity supply (provided that the lid is not frequently open and the machine has been working optimally).

Structure: ILRs are top opening and have two cabinets within it. They are equipped with baskets, and while freeze sensitive vaccines are kept in upper most layer of these baskets, the remaining vaccines can be kept on the sides and bottom of the baskets or if space is lacking, kept elsewhere in the ILR as shown in the picture. Vaccines are to be stacked neatly within their packing or even a waterproof container within the ILR. Care should be taken that labels of the vaccine vials do not come out due to the moisture within the cabinet.

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Module 3 - Vaccine and Logistics Management | 25

Current guidelines state that diluents should be stored always in ILRs along with vaccines unless there is a space constraint in the ILR.

Along with the vaccines, diluents should be placed at least 24 hours prior to use in the ILR; this would prevent the reconstitution of materials at different temperatures leading to thermal shock for the vaccines.

Unopened vaccine vials which have been returned from outreach sites are to be kept in a separate container/ box within the ILR and should be first utilized in the next session.

It is recommended that during distribution of vaccines the vials with the earliest expiry be utilized first. This is called EEFO (Early expiry first out) policy. Vials with vaccine vial monitor (VVM) near unusable stage should likewise be used earlier.

If batch numbers and expiry dates are the same, the vaccine which came first should be used first – FIRST IN FIRST OUT (FIFO).

Thermometers are to be placed in the center of the basket along with the vaccines and temperatures are to be checked twice daily manually and recorded. While recording the temperature, care should be taken that thermometer remains within the ILR and the reading is taken quickly. Taking the thermometer away from the ILR or taking time to note the reading would lead to incorrect reading.

Control panel in an ILR: ILRs have a control panel at the bottom right front-side corner which usually has a power switch, a digital reading pane and a thermostat.

• The digital reading pane may also give a temperature reading, however for purpose of noting twice daily readings the stem/ dial thermometer within the cabinet of the ILR is to be used rather than this digital pane.

• The thermostat is a revolving knob / sometimes a straight cut with numbers or bands around it. The knob or the cut can be turned around to regulate the temperature within the ILR. In summers the knob/ cut can be turned clock-wise for maximum efficiency and in winters it can be turned ante clockwise to prevent the cabinet temperatures dipping to sub zero levels.

• Sometimes green and red indicator lamps may also be present. The green lamp indicates that power is on and the red indicates temperature within the cabinet is not in safe range.

• Newer ILRs have more complex panels showing power on, compressor working, lock, alarm and frosting.

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26 | Health managers’ modules on Immunization

2. The Deep Freezer:

Use: These are electrical cold chain equipment used primarily to prepare ice-packs. In district and higher stores they may be used to store vaccines which are not freeze sensitive (like Oral Polio Vaccine [OPV] and Measles containing Vaccine [MCV])

Structure: The Deep Freezer is usually top opening with one or two large spaces / cabinets within it for preparing as well as storing the ice-packs.

Installation: While installing the Deep freezer care must be taken to keep it on a stand on even / level ground. Refrigerators and freezers should be spaced at least 10 cm away from walls and the equipment. The wiring must always be connected to a stabilizer.

Temperatures: Deep freezers need to generally maintain sub zero temperatures in order to freeze ice-packs and the recommended temperatures range between minus 15-25 degrees Celsius.

Ice pack preparation: The correct placement of ice-packs within the Deep freezer is important to ensure their effective preparation consuming least time and electricity. The ice-packs are to be laid out like several superimposed rows of bricks with spaces for sir movement in between.

Size and capacity: Deep Freezers generally come in two sizes, generally called small (found mostly in Primary Health centers and other peripheral stores) and large (in District and other higher stores). In a day, 20-25 ice-packs can be prepared in a small deep freezer while 35-40 ice-packs can be prepared in large Deep Freezers.

General care: Care also should be taken that Frost linings do not appear on the Deep-Freezer walls and edges. Lining of frost which are more than 5 mm prevent proper functioning of the machine and in these cases the machines must be defrosted by interrupting the electrical supply till all the frost melts. The frost should never be scraped with sharp instruments and knives. This will damage the equipment.

Control panel in a deep freezer: Deep freezers also have a control panel at the bottom right front-side corner which usually has a power switch, a digital reading pane and a thermostat.

Refrigerant gases: The Ice lined refrigerators and Deep Freezers work on coolant gases which used to be made on Chloro fluoro carbons (CFC). The gases in earlier machines were harmful to the environment and would disrupt the earth’s ozone later. It is therefore important to replace the equipment using CFC with those equipment which work on gases that are CFC free. Usually a sticker put by the company on the equipment reveals whether the equipment is CFC or CFC free.

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Module 3 - Vaccine and Logistics Management | 27

Holdover time is the time taken for increasing the temperature of vaccines at the time of power failure from its minimum range to its maximum range, subject to the condition that the equipment is functioning well. For example, if the inside temperature of an ILR is 2oC at the time of power failure, the time taken up to reach 8oC will be the holdover time of that ILR. Holdover time depends on the frequency of opening the lid, the quantity of vaccines kept inside with adequate space between the boxes, exposure to direct sunlight and, only in the case of non-electrical cold chain equipment, the condition of icepacks placed inside. Holdover Time varies from one manufacturer to the other.

3. Voltage Stabilizer:

Use: The function of a voltage stabilizer is to maintain a steady output of voltage within a safe recommended range. They are able to modify fluctuations in voltage to some extent to provide uniform range of electricity to the equipment to which it is attached.

Type: Generally voltage stabilizers of 1 kva are supplied for the UIP which can work when the input current ranges for 150 to 280 V. However low range stabilizers which can work between 110 -280 volts can also be used where necessary. The stabilizer is expected to give an output voltage of 200 to 240 volts.

Installation: It is recommended that the power cord of 1 electrical cold chain equipment ( an Ice lined refrigerator or a deep freezer) be connected to a single stabilizer.

The stabilizer itself should be mounted on a stand and connected to an electrical supply. Care should be taken that there are no loose wiring and the earth wire is also appropriately provided.

4. Cold Boxes:

Use: Cold boxes are insulated boxes used mainly for transporting vaccines and sometimes (in case of emergencies) also used for storing vaccines.

Sizes: The cold boxes are supplied in different sizes: 5, 8, 20 and 22 liters. The smaller boxes can hold about 1500-2400 doses of mixed antigens while the larger boxes can hold about 6000 doses of mixed antigen.

Care:

• Within a cold box, Ice packs should be arranged as given in the diagram on the inside of the lid

• Adequate care should be taken to use conditioned ice packs in cold boxes when transporting vaccines.

• Freeze sensitive vaccines should not directly come in contact with the icepacks.

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28 | Health managers’ modules on Immunization

• The cold boxes should always be “lifted” up from both sides and NEVER be dragged from one side.

• Cold boxes should never be sat on as it damages the gasket (rubber tubing around the edges).

• Cold boxes can be stacked a-top one another but the stacks can be up-to only three levels (or as recommended by the manufacturers).

• Clean the cold boxes after use.

Hold over time: Vaccines can be kept in a 5 l cold box for 90 hrs and a 20 l cold box for six days when the ambient temperature is 43 degrees Celsius provided that the boxes are fully functional and not opened during this period.

5. Vaccine carrier

Use: Vaccine carriers are used for carrying small quantities of vaccines (16-20 vials) to the sub-centers or session sites.

Make and structure: The vaccine carriers are made of insulated material, the quality of which determines the cold life of the carrier. Four ice packs are laid in the vaccine carrier as per manufacturer’s guidelines. Conditioned icepacks should only be placed and the lid of the carrier should be closed tightly.

The vials of DPT, TT and Hep B vaccines should not be placed in direct contact with the frozen ice packs.

How to pack a vaccine carrier

• Confirm that there are no cracks in the walls of the vaccine carrier.

• Take out the required number of ice packs from the deep freezer and wipe them dry. Keep them out side for conditioning before placing into carrier.

• Place four conditioned ice packs in the carrier and wait for few minutes for temperature to fall to less than 8 degree Celsius in the carrier.

• Wrap vaccine vials and ampoules in thick paper before putting in polythene bag so as to prevent them from touching the ice packs.

• Place some packing material between `T’ series vaccine and the ice packs to prevent them from touching the ice packs.

• Place foam pad at the top of ice packs.

• Ensure that some ice is present in the ice packs while conducting immunization sessions.

• Secure the lid tightly.

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Module 3 - Vaccine and Logistics Management | 29

6. Ice packs

Use: Ice packs are key component of the cold chain. It is used for ice lining inside the cold box and vaccine carrier.

The ice packs for cold box are different from vaccine carrier and these should be used as per the manufacturer’s guidelines.

Before placing in the deep freezer, water should be filled up to the level mark on the icepack. Cork should be tight so that there is no leakage. If there is any leakage, such ice packs should be discarded.

Conditioning of ice-packs:

Icepacks come out of the freezer at a temperature of about -20ºC. They need to be kept at room temperature for a period of time to allow the ice at the core of the icepack to rise to 0ºC. This process is called ‘conditioning’. The standard advice has been that an icepack is adequately ‘conditioned’ as soon as beads of water cover its surface. Experiments have shown that this is not always the case and that cold-sensitive vaccines - particularly Hepatitis B - can still freeze inside the cold box even when icepacks have apparently been conditioned correctly.

When icepacks are laid out on a table they create their own microclimate. This extends the conditioning process. The following procedure is recommended:

• Leave a 5 cm space all round each icepack.

• Lay out icepacks, preferably in single rows but never in more than two rows.

• Wait until there is a small amount of liquid water inside the icepacks. This will take up to one hour at +20ºC and rather less at higher temperatures. Shake one of the icepacks every few minutes. The ice is conditioned as soon as it begins to move about slightly inside its container.

https://apps.who.int/vaccines-access/vacman/transport/conditioningicepacks.htm

7. Maintenance and repairs of cold chain equipment

As a manager you would have overall responsibility for the proper functioning and upkeep of all equipments in your facility. It would help to main a register with details of equipment including model and make numbers. These are usually found at the back side of the equipment.

The following activities and indicators are all related to proper maintenance of the equipment and it is important for the manager to understand and apply them.

Installation: It is the proper setting up of the equipment in relation to the site, manner and method often as instructed by the manufacturer. Electrical fittings are best left to a well trained electrician and some equipment may require carpentry for stands and pallets. Some companies may also provide mechanics for the installation of equipments.

Preventive maintenance: Electrical equipment requires maintenance even when they are functional. Refrigerator mechanics should undertake a preventive maintenance exercise at least one a year. This would include cleaning of parts, charging of refrigerant gases if required and minor repairs. For

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30 | Health managers’ modules on Immunization

the proper functioning of cold chain equipment it is recommended that installation is carried out properly and preventive maintenance is undertaken at least once a year.

Defrosting and cleaning of the equipment are also essential steps in preventive maintenance that can be undertaken on a frequent regular basis by the cold chain handler and does not need the intervention of a refrigerator mechanic or a repair team.

Down time: Down time is the period for which any electrical equipment remains dysfunctional. Down time should not be more than 7 days as prolonged time would mean having to make alternate arrangements in order to maintain the potency of vaccines. Like-wise the less the response time the better.

Response time: The time taken between reporting the non-functional status of the equipment and its visit by the refrigerator mechanics team. Depending on availability and efficiency of response teams, 2 days is an acceptable response time. A response rate may also be computed for a large number of equipments over a period of time by averaging the response times for individual equipment.

Sickness rates: The proportion of electrical cold chain equipment of any given area which is dysfunctional at a given time as computed against the total available electrical cold chain equipment. For the Immunization program to run effectively and for the cold chain equipment to be used efficiently, the sickness rate of cold chain equipment should not be more than 2%.

Condemnation: The process of disposing all non repairable cold chain equipment. A large number of condemned equipment often clutters valuable space in cold chain rooms. Managers need to understand the procedures for condemnation of equipment and help in clearing off condemned material.

Picture showing exposed cold chain boxes in the foreground and condemned equipment under the shed in the background in a cold chain store.

E. Temperature monitoring:

Correct, reliable and consistent monitoring of temperature where-ever and when-ever vaccines are manufactured, stored, transported and used is an important activity to ensure potent and effective vaccines reach the beneficiary.

Temperature monitoring is therefore not a one-off activity but a continuous task that must be responsibly carried out at every level.

Thermometers

Thermometers need to be available with storage equipment so that vaccines are stored within recommended temperatures.

There are a variety of thermometers used in cold chain equipment but the popular ones are:

1. Alcohol stem thermometer

2. Dial thermometer

3. Digital thermometer

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Module 3 - Vaccine and Logistics Management | 31

Thermometers which are used in cold chain should all have provision to record sub-zero temperatures. The photo alongside shows a thermometer, it has markings of recording range both above and below zero degrees Celsius.

The green markings indicate recommended temperature ranges for ILR (above 2-8 degrees Celsius) and Deep Freezer (below, minus 15 to 25 degrees Celsius).

The alcohol stem in the middle will rise-and-fall according to changes in temperature and will indicate the reading to be noted.

Temperature recording

When measuring the temperature of an ILR and Deep freezer, care must be taken not to remove the thermometer away from the cabinet; the recording should also be done quickly. Both these practices will prevent the thermometer from being exposed to outside temperature and will give a more accurate reading.

The standard practice is to take temperature readings twice a day, including holidays and Sundays. The timings are morning and evening on fixed times as decided by the regular cold chain handler. These recordings must also be documented in a standard register and verified time-to-time by the supervisors and managers.

Exercise: Note the temperature readings of 10 days and note in the graph. Comment on observations and potential damage to heat and freeze sensitive vaccines during this 10 day period:

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32 | Health managers’ modules on Immunization

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Module 3 - Vaccine and Logistics Management | 33

Compare the readings in the temperature records of 2 ILRs and comment!

All persons related to cold chain and vaccines need to ensure and check that vaccine vials are not exposed to damaging amounts of heat, light or freezing. The Vaccine vial monitor is a simple tool which can help in the interpretation of excessive exposure to heat whereas when exposure to freezing temperatures is suspected, the shake test, described below, can help in determining the usability of freeze sensitive vaccine batch.

Vaccine vial monitors: A VVM is a label containing a heat-sensitive material which is placed on a vaccine vial to register cumulative heat exposure over time.

The combined effects of time and temperature cause the inner square of the VVM to darken gradually and irreversibly. Before opening a vial, check the status of the VVM.

Does a VVM measure vaccine potency? No, the VVM does not directly measure vaccine potency but it gives information about the main factor that affects potency: heat exposure over a period of time. The VVM does not, however, measure exposure to freezing that contributes to the degradation of freeze-sensitive vaccines.

VVM markers are placed on the labels of liquid vaccines (OPV, DPT, Hep B) and on the caps of vaccines which need reconstitution (BCG, Measles). On opening the caps of the dry vaccines, the VVM becomes irrelevant. However, it is expected that the vaccines are reconstituted (mixed) immediately with the same diluents (mixing solvent) supplied by the supplier and then USED WITHIN 4 HOURS. After 4 hrs the reconstituted vaccines need to be discarded.

Usable Stages Unusable Stages

Reading the Stages of the VVM

The inner square s lighter than the outer circle.

If the expiry date has not been passed:

Use the vaccine

Discard Point

The color of the inner square matches that of

the outer circle: DO NOT use the vaccine.

If the color of the inner square is darker than the outer circle, DO NOT use the vaccine.

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34 | Health managers’ modules on Immunization

Freezing of vaccines and shake tests: This test is to be undertaken for vaccines which are SUSPECTED to have been frozen AND NOT FOR vaccines which ARE FROZEN and can be seen as such. FROZEN VACCINE must be immediately discarded.

http://vimeo.com/8389435

Take a vaccine vial you suspect may have been frozen – This is “test” sample.

• Take a vaccine vial of the same type, same manufacturer, and same batch number as the suspect vaccines vial you want to test.

• Freeze solid this vial at (-) 20oC overnight, and this is the ‘CONTROL’ sample and label as FROZEN to avoid its usage.

• Let it thaw. Do NOT heat it.

• Hold the Control and the Test sample together in hand and vigorously shake the samples.

• Place both vials to rest on a flat surface, side-by-side and observe for 30 minutes.

• Compare for rate of sedimentation.

• If the sedimentation in the ‘Test vial” is slower than in the “Frozen vial”: The vaccine has not been damaged.

• Use the vaccine batch – it is not damaged.

• If the sedimentation is similar in both vials or if sedimentation is faster in the “Test” vial than in the “Frozen” vial: The vaccine is damaged.

• Damaged vaccines need to be recorded as such in the vaccine stock register and discarded as per guidelines.

Freeze watch/ Freeze tags

Freeze tags are generally used while transporting large quantities of freeze sensitive vaccines. The tag is to be placed in between the stocks of vaccines being transported / stored.

The display will indicate a tick or a cross and has a built in alarm.

When the temperature surrounding the Tag reaches sub-zero (-0.5) temperature, for more than 60 minutes, the tick in the display panel tag is replaced by a cross. There will be no alarm beep or sound. The cross mark is the alarm indicator.

The cross in the tag would indicate that the freeze sensitive vaccines stored/ transported along with have been frozen and need to be discarded.

Electronic data logger:

The electronic data loggers are also being introduced to monitor the temperature of ILR. It is an electronic device placed with the vaccine which records the vaccine temperature for 30 days. It has visual display alarm system As the temperature of the equipment storing the vaccine crosses the safe range the visual alarm alerts the handlers.

Use

Discard

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Module 3 - Vaccine and Logistics Management | 35

This device assists in temperature monitoring through following features:

1. It shows current temperature of ILR in digital LCD screen at all the time

2. It indicates if there was any alarming situation during the past 30 days. The device shows “Alarm” on LCD screen if there was any alarming situation in past 30 days. The alarming situation is when the temperature went above +8 Degree Celsius over a consecutive period of ten hours or temperature drops down below -0.5 Degree Celsius for a consecutive period of 60 minutes.

3. It shows the duration of temperature violation for every alarming situation happened in past 30 days.

To see the duration of temperature violation, device is equipped with a “Read” button which guides the user through the history of past 30 days starting from “today” till “30 days ago”.

4. It shows an “OK” sign if there has been no violation of temperature in past 30 days.

5. It has a shelf life of two years from the date of activation of device. The devise once activated, cannot be stopped through-out its operational life. Hence, it provides round the clock monitoring of ILRs without any need of intervention of user for two years of time.

6. It has been specifically designed to be used with ILRs that are required to maintain the temperature between +2 to +8 Degree Celsius.

F. Transport

Arrangement for transport is one of the most important components of logistics management. While most facilities would have a vehicle at their disposal to collect vaccines and logistics from higher stores when collections are to be made, at some facilities the manager may have to arrange for hired transport.

Districts and higher stores would have have a vaccine van which should be used exclusively to transport cold chain logistics.

Apart from ensuring the arrangement of the vehicle are ready at hand, other essentials like an available driver, POL (petrol/deisel/oil/lubrication), an accompanying person, several cold boxes with conditioned ice-packs and the requisition papers must always be ready when making logistics collection.

Ensure loading and unloading of vaccines is done during cooler times of day (early morning, evening) and the van is not left in the sun for long. Ensure somebody is there at the place of unloading so that vaccines are immediately transfered from cold boxes to ILRs.

There should be planned and fixed days for collection, often cyclical and once monthly, from the higher stores and not erratic on episodes of stock outs and emergencies. This would only be possible when there is proper logistics planning and coordination between the supplying and receiving stores.

Apart from collection, proper arrangement is also required for distribution of vaccine and logistics. The terrain and difficulties of far away outreach sites should particularly kept in mind while making the arrangement. The further distribution could be outsourced to local volunteers or organizations and is called “alternate vaccine delivery”. The routes, persons responsible, the timings and the logistic materials and quantities need to be meticulously planned and worked out to ensure the 5 rights and no session is cancelled for lack of timely arrival of complete logistics.

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36 | Health managers’ modules on Immunization

G. Stocks

Logistics management ensures regular and smooth flow of vaccines and other supplies to all health facilities. To ascertain that an appropriate amount of vaccine is always available, ensure that supplies are checked continuously, and records of all stock movements in and out of storage areas, are maintained.

Three commonly encountered problems in vaccine and logistics management are;

• Stock out: A condition when no stock is available of a vaccine or other supply.

• Inadequate Stock: less than the buffer stock (i.e. less than 25% for vaccines and 10% for syringes)

• Excess Stock: more than the requirement for one month, including the buffer stock (i.e. more than 125% for vaccines and 110% for syringes).

Logistics management is a cyclical process and involves several steps, namely demand estimation, indenting, receipt, storage and distribution of vaccines and other supplies to health facilities in a timely fashion and at an optimum cost.

Step 1: Estimate requirements and indent

Compile the micro plans of all the sub-centers at the PHC level and estimate the requirement of vaccines and other supplies. UIP requires that at the:

• Block/PHC: 1 month of vaccines and supplies are stored

• District: 3 months of vaccines and supplies are stored

Furthermore, ensure that the overall estimate includes a buffer or safety stock (25% for vaccines and 10% for syringes).

The buffer stock serves as a cushion or buffer against emergencies, major fluctuations in vaccine demands or unexpected transport delays.

The problems of stock out, inadequate or excess stock can be avoided if a minimum/maximum inventory control system is implemented. This system ensures that the quantity in hand is always between established maximum and minimum stock levels.

The Minimum stock level (also known as the re-order level) implies the least amount that you should have in stock or the level which, when reached, initiates a re-order; usually expressed as the number of weeks/months of supply. It is the amount of stock you will use in the time between placing and receiving an order plus the buffer stock. The minimum stock level is the level below which stocks should never drop without having placed an order.

Supplies are reordered based on their rate of consumption to ensure that stock-outs are avoided. The reorder factor can be used for calculating the reorder level and the quantity to reorder each time.

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Reorder factors and reorder levels

The Reorder Factor is based on doubling the number of months in the order period and adding an extra month. It is used to calculate the reorder level and the quantity to reorder each time.

If supplies are delivered once a month, the reorder factor is 3

If every 2 months = 5

If every 3 months = 7

If every 4 months = 9

The reorder level is the stock threshold below which an order should be placed and is also the quantity to reorder at that time.

Reorder level is calculated as follows:

Average monthly consumption (AMC) x reorder factor = reorder level

The reorder factor, shown in the box below, takes into account an additional safety stock to allow for unexpected demands and delays in transport.

Reorder Factor = (Number of months in the order period * 2) + 1

The reorder level is the threshold below which an order should be placed and is also the quantity to reorder at that time.

The steps below are commonly used to order stock based on past consumption:

1. Using stock cards, calculate the average monthly consumption (AMC) of each item in the store.

2. Determine how often the facility receives deliveries.

3. Determine the reorder factor of each item in your store based on the information in the box (above).

4. Calculate the reorder level by multiplying the average monthly consumption by the reorder factor.

5. Determine when and how much to order by comparing the reorder level with the balance in stock.

If the balance in stock is more than or equal to the reorder level, it is not time to reorder. If the balance is less than the reorder level, it is time to reorder. Order the reorder level of the item.

6. Place the order in writing to the medical supplier.

The Maximum stock level implies the largest amount of stock that you should have, usually expressed as the number of weeks/months of supply. It is the minimum stock plus the amount of stock used between orders. The maximum stock level is set to guard against excess stock which results in losing vaccines to expiration before use.

The Lead time refers to the time between ordering of new stock and its receipt. The lead time varies, depending on the speed of deliveries, availability and reliability of transport, and sometimes the weather.

Example:

Reordering medicines for the X district

Item: Crocin tablets 500 mg

AMC = 40 strips

Delivery Frequency = every 2 months

Reorder factor = 5

Reorder level = 40*5 = 200 strips

On 1 April, balance in stock is 213. Order no Crocin.

On 1 May, balance in stock is 178. Order 200 strips of Crocin.

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38 | Health managers’ modules on Immunization

Step 2: Receive

During receipt, check and record the details of vaccines, diluents and other supplies and sign in the vaccine and logistics supply voucher.

When the supplies reach the PHC, also enter the details in the vaccine and logistic stock register each time they arrive at the storage point, including Batch numbers, Expiry dates, VVM status, etc.

Systematically arrange vaccines and supplies to facilitate issue of stocks whose expiry date is the closest i.e. distribute vaccine with the shortest shelf-life first, even if it arrived last. This system, commonly known as EEFO (Earliest- Expiry-First-Out) is preferable to FIFO (First-In- First-Out) handling.

While in storage, periodically conduct a physical inventory of all vaccines once every month and other supplies at least once every three months.

Check and record the details at the bottom of the stock register. Include only vaccine stocks that are suitable for use and kept in the cold chain. Any expired vials, freeze-damaged vials or vials with VVMs beyond the discard point should not appear in the available stock balance and also should not be kept in the cold chain. If such vaccines have to be retained for some time, e.g. until accounting or auditing procedures have been completed, clearly mark/label them for discard in the Stock Register until final disposal takes place.

Ensure that the following good storage practices are in place:

• Stock security: keep all vaccines and consumables under secure (lock and key) conditions.

• Data security: keep all records secure.

• Orderliness: store all vaccines, diluents and droppers and other consumables in an orderly fashion.

• Cleanliness: keep the vaccine store clean, dry and free of pests.

• Supervision: ensure that all staff is effectively supervised.

• Accountability: depute a person to manage stores.

Step 4: Issue and Use

Follow the earliest expiry, first out (EEFO) procedure during distribution. Follow the FIFO principle if all the vaccines and supplies are of the same shelf-life.

Check that the types and amount of vaccine, diluent and dropper are the same, as per microplan for that session site. Check the status of randomly selected vials for intact labels, expiry date, VVM and freezing.

Check and record details, in the stock register, of vaccines and supplies every time they leave the storage point for distribution to session sites and, eventually, the user.

Calculate and record the end balance of the stock.

Ensure that the health worker is present to receive the stocks at the expected time of delivery. Record the issue of vaccines and supplies to each session site in the Vaccine and Logistics Issue Register with the date, signature of delivery person, and signature of PHC official.

At the PHC level, ensure that doses used, discarded and returned to the PHC at the end of the session are recorded in the stock register.

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Module 3 - Vaccine and Logistics Management | 39

Since provision of immunization services depends on the simultaneous availability of a number of related supplies, shortage or stock-out of any of these negatively impacts the program.

Bundling ensures that vaccines are always supplied with diluents, droppers, AD syringes and reconstitution syringes, in corresponding quantities, at each level of the supply chain. Also supply other related items (e.g. Tablet IFA, ORS) required for the conduct of Village Health and Nutrition Day.

H. Tools

Give example, demonstrate, and give exercises where the mangers identify incorrect and incomplete entries! Use and demonstrate the current registers and formats used in your state.

Registers:

Temperature record register

Vaccine stock register

Injection stock register

Logistics distribution register

Equipment stock register

Pass books / Indent vouchers

Charts:

Stock record chart

Software:

PROMIS

Orissa VLMS

Job aids: storing it right

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40 | Health managers’ modules on Immunization

I. Waste Disposal

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Module 3 - Vaccine and Logistics Management | 41

DESIGN OF THE PIT/TANK FOR DISPOSAL OF TREATED NEEDLES AND BROKEN VIALS (SHARPS)

The treated needles/broken vials should be disposed in a circular or rectangular pit as show below. Such a rectangular or circular pit can be dug and lined with brick, masonry or concrete rings. The pi should be covered with a heavy concrete slab, which is penetrated by a galvanized steel pipe projecting for about 1 meter above the slab, with an internal diameter of up to 50 milimeters or 1.5 times the length of vials, whichever is more. the top opening of the steel pipe shall have a provision of locking after the treated waste sharps has been disposed in. When the pit is full it can be sealed completely, after another has been prepared. For high water table regions where water table is less than 6 meters beneath bottom of the pit, a tank with above mentioned arrangements shall be made above the ground.

J. Emergency management

For effective logistics management it is important to have arrangements and back-up plans for a variety of emergency and contingency situations. Some of these situations are described below:

Break down of cold chain equipment:

• Keep a record of make and model numbers of all cold chain equipment.

• Know where and who to report in case of break downs; have a list of persons/ agencies for equipment repair with contact numbers readily available.

• Ensure that the local cold chain handler is trained in trouble shooting for small problems.

• Arrange for other equipment to shift vaccines: in case ILR breaks down (and there is no other ILR), vaccines are best shifted to a cold box with conditioned ice packs (freeze tags would also help)

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42 | Health managers’ modules on Immunization

Disruption of electric supply

• Know the hold over time (Time in hours without external power that all points in vaccine compartment remain between +2°C and +10°C which is usually above 20 hours) of the ILR equipment that is in your facility

• Avoid unnecessary opening and closing of ILR and deep freezer

• Ensure proper connections are available for back-up power supply such as generator sets, use back up power when needed.

• Keep track of the hours of disrupted power supply and use alternate arrangements if power back up becomes unavailable

• As a last resort also keep details of the nearest cold chain store where vaccines can be moved if needed.

• In some states will poor electricity availability facilities have identified ice-factors and cold storage deports to freeze ice-packs.

Absenteeism of critical personnel

• Ensure at least two persons are trained in cold chain and vaccine management in each facility, so that if one is absent, the other can continue with the management.

• Ensure someone is available during Sundays and holidays for recording equipment temperature.

• It is also important to ensure keys to the equipment, cold chain room and stock records and registers are readily available if the regular cold chain handler is not present.

• Have job aids on important cold chain related activities that can be followed by back-up person (e.g. measuring temperature, conditioning ice-packs, loading and ILR)

Vaccines and logistics getting beyond expiry date and usable stage of VVM

• Note the batch number, quantity of vaccines and reason why they have to be discarded in the stock register

• Inform the Officer-in-charge of the facility about the situation, report higher store if necessary (or if large quantities have to be discarded)

• Remove the vaccines from cold chain

• Dispose as per CPCB guidelines; maintain correct records about discarded vaccines.

Sudden requirements in campaigns and outbreaks

There may be instances of special vaccination drives or outbreaks response (vaccination may/ may not be indicated during outbreaks; get the correct guidelines from policymakers and senior program managers) where larger than normal quantities of vaccines are required.

Logistics planned well in advance are critical to the success of such drives and responses. Some of the steps are:

• Order vaccines in advance.

• Prepare for additional space, such as another ILR or cold boxes.

• Also prepare for additional freezing of ice-packs.

• In case of inadequate space, vaccine can be supplied in multiple supply cycles. If the activity is spread out across several days or weeks, vaccines can be ordered in lots.

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Module 3 - Vaccine and Logistics Management | 43

PHC: Garhi, (Prepared: March 2008)

When to act:

• ILR / Deep Freezer breaks down OR

• Electricity failure of more than 24 hours

Who will act:

• Kashinath Soni (Health Assistant Male and Cold Chain Handler)

What to do:

ILR Transfer vaccine to the cold box with conditioned icepacks. Place a thermometer inside the cold box.

Deep Freezer Freeze icepacks in Kejriwal ice factory at Navapura. Contact person Ashutosh Kejriwal (Ph. XXXXX)

In case of ILR/DF breakdown, immediately inform:

Designation Name Phone (O) Phone (O)MOPHC Dr Bhawar Singh XXXXX XXXXX

DIO Dr Rathore XXXXX XXXXX

District Cold Chain Technician

Sunil Kumar XXXXX XXXXX

Record details of breakdown in inventory register and UIP Monthly PHC Performance Report

Sample Emergency Plan for Vaccine Store:

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Module 3 - Vaccine and Logistics Management | 45

1. There are 5 Rs required to ensure regularity, consistency and quality of logistic management. Match the Rights with their correct meaning.

a) Right quantity

b) Right quality

c) Right commodity

d) Right time

e) Right place

a) Required vaccines, diluents, syringes, vitamins, medicines, equipment, material for communication

b) Requisite amounts so that no beneficiary is turned away

c) As decided in the micro plan, socially acceptable site, accessible to all beneficiaries.

d) Within expiry date, correct vaccine vial monitor, no frozen freeze sensitive vaccines.

e) A time suitable for both service provider and beneficiary

a) a-e; b-d; c-a; d-c; e-b

b) a-c; b-a; c-e; d-b; e-d

c) a-d; b-e; c-a; d-b; e-c

d) a-b; b-d; c-a; d-e; e-c

2. What is cold chain?

a) It is a system to test the potency and effectiveness of a vaccine at low temperatures.

b) It is a system of storing and transporting vaccines at recommended temperature range from the point of manufacture to the point of use.

c) An equipment to ensure that the temperature range is maintained during vaccine storage and transportation.

d) It is a system of storing and transporting vaccines in frozen state.

3. Which of the following group of vaccines would be permanently damaged if frozen?

a) Hepatitis B, DPT, TT

b) Measles, DPT, OPV

c) DPT, TT, OPV

d) Hepatitis B, OPV, TT

4. What are the main functions of a manager in ensuing efficient logistic management of vaccines?

a) Calculating correct requirement of each vaccine and ordering supplies from higher level

b) Ensuring that the received vaccine are stocked and stored at the facility under required conditions.

c) Making sure that the vaccines are distributed to all catchment areas including outreach areas and these are utilized properly at beneficiary level.

d) All of the above.

Final Assessment:

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46 | Health managers’ modules on Immunization

5. Which of the following vaccine can be stored in freezing conditions, if required?

a) TT

b) Measles

c) Hepatitis B

d) DPT

6. Which 3 vaccines are more sensitive to high temperature?

a) Hepatitis B, TT, BCG (before reconstitution)

b) Hepatitis B, TT, Measles.

c) BCG (after reconstitution), OPV, Measles

d) BCG (before reconstitution), TT, Hepatitis B.

7. After reconstitution, BCG and Measles vaccine should be used:

a) Within 4 hours

b) Within 8 hours

c) Within half an hour

d) Within 24 hours

8. Which of the following vaccines are light sensitive and are therefore packed in amber coloured vials?

a) DPT and OPV

b) Hepatitis B and OPV

c) Measles only

d) BCG and Measles

9. Who is responsible for the supervision of stocks & equipment, temperature maintenance, distribution of vaccines and physical counting and checking of vaccines at vaccine cold chain stores?

a) District Immunization Officer

b) Block Manager

c) Block Medical Officer

d) All of the above

10. What is the most important equipment for storing vaccines at block level and lower stores?

a) Deep Freezers

b) Vaccine Carrier

c) Ice Lined Refrigerator (ILR)

d) Refrigerator

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Module 3 - Vaccine and Logistics Management | 47

11. What is the ideal temperature range maintained in the ILR?

a) 2-8° C

b) 0-2° C

c) 4-8° C

d) 8-12° C

12. Which of the following cold chain equipment is used primarily to prepare ice-packs?

a) Cold Boxes

b) Ice Lined Refrigerator

c) Deep Freezer

d) Refrigerator

13. What precautions should be taken while operating ILR?

a) Place diluents at least 24hrs prior to use

b) Keep thermometer in center of the basket and check temperature twice daily

c) Policy of Early expiry first out

d) All of the above

14. The temperature to be maintained in deep freezer is

a) 2-8° C

b) -15 to -25° C

c) 8-12° C

d) 0-2° C

15. How are freeze sensitive vaccines (Hepatitis B, DPT, TT) stored in an ILR?

a) Sides of the basket

b) Bottom of the basket

c) Upper part of the basket

d) Outside ILR

16. Which of the following equipments should preferably be avoided for transporting vaccines?

a) Cold Boxes

b) Day Carriers

c) Vaccine Carrier

d) None of the above

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48 | Health managers’ modules on Immunization

17. Which of the following cold chain equipment is used for carrying small quantities of vaccines to sub-centres or session sites?

a) Vaccine Carrier with frozen ice packs

b) Ice Packs alone

c) Cold Boxes

d) All of the above

e) None of the above

18. What is meant by conditioning of Ice Packs?

a) The process in which the ice packs are kept in the refrigerator to increase the cool mass so as to maintain temperature during power failures

b) The process wherein the vaccine pack is intervened by the layer of plastic/bubble wraps/Styrofoam peanuts from coming in direct contact with ice packs

c) The process of keeping the ice packs at room temperature for a period of time to allow the ice at the core to rise to 0°C

d) None of the above

19. Sickness rate refers to

a) Computation for a large number of cold chain equipment over a period of time by averaging the response times for individual equipment

b) Proportion of electrical cold chain equipment of any given area which is dysfunctional at a given time as computed against the total available electrical cold chain equipment

c) The number of children getting sick following the immunization or any given time

d) Process of disposing a large number of condemned equipment

20. Manager has the responsibility of ensuring proper functioning and upkeep of all the equipments in your facility. What is the acceptable down time in case of any dysfunctional electrical equipment?

a) 7 days

b) Within 24 hrs

c) 2 days

d) None of the above.

21. For the Immunization program to run effectively and for the cold chain equipment to be used efficiently, the sickness rate of cold chain equipment should not be

a) More than 1%

b) More than 4%

c) More than 2%

d) None of the above

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Module 3 - Vaccine and Logistics Management | 49

22. The time taken between reporting the non-functional status of the equipment and its visit by the refrigerator mechanics team is

a) Preventive Maintenance

b) Response time

c) Condemnation

d) Down Time

23. Vaccine Vial Monitor is

a) A heat sensitive material placed in a vaccine which changes colour and helps in interpretation of vaccines of excessive exposure to heat.

b) A heat sensitive label placed on a vaccine vial to register cumulative heat exposure over time.

c) A tool to detect the excessive exposure of vaccines to freezing temperatures.

d) A monitoring tool which directly measures the potency of the vaccine.

24. A condition when no stock is available of a vaccine or other supply is termed as

a) Inadequate stock

b) Less Stock

c) Buffer stock

d) Stock out

25. The -------------------------------- serves as a cushion or buffer against emergencies, major fluctuations in vaccine demands or unexpected transport delays.

a) Buffer stock/Safety stock

b) Re-order level

c) Minimum Inventory Control system

d) Maximum stock level

26. The lead time refers to the

a) Time between ordering of new stock and its receipt

b) The time between placing and receiving an order plus the buffer stock

c) The largest amount of stock, usually expressed as the number of weeks/months of supply

d) All of the above

27. Follow the FIFO principle if:

a) All vaccines and consumables are under secure conditions

b) If all vaccines, diluents and droppers and other consumables are kept in orderly fashion

c) All vaccines and supplies are of the same shelf-life

d) All of the above

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50 | Health managers’ modules on Immunization

28. The process of ensuring that vaccines are always supplied with diluents, droppers, AD syringes and reconstitution syringes at each level of the supply chain is called as --------------------------?

a) Maximum inventory control system

b) Bundling

c) Maximum stock level

d) None of the above

29. What are important precautions to be taken during temperature recording/monitoring of cold chain equipments?

a) Appropriate thermometer (record sub-zero temperature)

b) Recording to be taken quickly with thermometer within cabinet

c) Record temperature twice a day

d) All of the above

e) None of the above

30. You are responsible for ordering supplies at a first-level health facility. The item to be ordered is Vitamin A (bottles). The average monthly consumption is 3 bottles and frequency of delivery is once per month. What would be the reorder factor and reorder level?

a) 2; 6

b) 3; 9

c) 4; 8

d) 6; 3

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Module 3 - Vaccine and Logistics Management | 51

• Immunization Handbook for Medical officers (Revised Edition 2011) Department of Health and Family Welfare, Government of India.

• Immunization Essentials: A Practical Field Guide (October 2003), Technical writing group, USAID

• Handbook for Vaccine & Cold Chain Handlers 2010 Department of Health & Family Welfare

• Ministry of Health and Family Welfare, Government of India

• Common Requirements for Logistics Management Information Systems Produced with the Collaborative Requirements Development Methodology (CRDM) September 30, 2010 www.path.org

• WHO-UNICEF Effective Vaccine Store management Initiative: Modules 1-4. Immunization, Vaccines and Biologicals, WHO, UNICEF 2005

• Safe vaccine handling, cold chain and immunizations A manual for the Newly Independent States GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION EXPANDED PROGRAMME ON IMMUNIZATION World Health Organization, Geneva, 1998. Produced in collaboration with Basics, USAID and UNICEF

• Publication: Bulletin of the World Health Organization; Type: Research Article DOI: 10.2471/BLT.09.05687 Page 1 of 17 Ümit Kartoğlu et al. Shake test to detect vaccine damage from freezing Validation of the shake test for detecting freeze damage to adsorbed vaccines

• Guideline for establishing or improving primary and intermediate vaccine stores WHO/V&B/02.34 ORIGINAL: ENGLISH Vaccines and Biologicals World Health Organization, Dec 2002.

• Temperature sensitivity of vaccines. Immunization, Vaccines and Biologicals, WHO, August 2006

• VACCINE DELIVERY INNOVATION INITIATIVE Project Summary CKS Consulting Pvt. Ltd.

• Vaccine Delivery Innovation Initiative Copyright © 2009-10 Bill & Melinda Gates Foundation

• OPTIMIZE Strategy, PATH and WHO various newsletters and reports

• https://apps.who.int/vaccines-access/vacman/transport/conditioningicepacks.htm Website accessed on 11th July 2011.

• http://vimeo.com/8389435 Website accessed on 11th July 2011.

References:

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Module 3 - Vaccine and Logistics Management | 53

Module 3: Logistics management (4 hrs)

Section Method (time) ToolI. Case studies Divide participants into groups; give them case

studies (A) and (B).

Ask them to read and highlight the reasons behind the success of Amul and Dabbawala’s . (20 mins)

Show them pictures from module on vaccine logistics systems (Figure 1 to 6) and ask them to comment!

Case studies A and B

Figures 1 to 6

II. Key principals Marking arrows and putting a story board/ Flip chart / presentation with definition and smart graphics. Participants will have to explain the definition and graph/story board. (10 mins)

Story board pictures with story board/ principals in flip chart/presentation

III. Key components

a) Personnel

Role play: 5 participants play the role of different personnel involved in cold chain and vaccine management and describe their roles, activities and tasks assigned. (10 mins)

b) Materials Discussion of various program components of VHND and materials required (10 mins)

c) Space 2 groups to enlist storage space; (A) recommended and (B) not recommended and present (10 mins)

d) Equipment Demonstration of each equipment hands on by the facilitator (45 mins)

Discussion on maintenance issues and indicators

All moveable cold chain equipment or visit to the cold chain store/ indicators in flip chart/presentation

e) Temperature monitoring

Demonstration of thermometer, freeze tag, data logger and exercise on reading and interpreting measurements.

Interpreting two temperature records.

VVM interpretation

Shake test: video

(45 mins)

Thermometers, freeze tag, data logger, temp recording book. Exercise sheet for temperature reading.

Temperature log book records: 2 types.

VVM in flip chart/presentation

Video clip

f ) Transport Short discussion (10 mins)

g) Stocks Demonstration/ presentation of stocks

(15 mins)

Flip chart/ presentation

h) Procedures Explanation of EEFO, FIFO and bundling (10 mins) Presentation/Flip chart

i) Tools Demonstration by participants of different register/job aids/tools available (15 mins)

Distribute state relevant recording and reporting tools, job aids etc among participants, ask them to come up and describe each tool. Software and its use will have to be demonstrated.

Facilitators’ guide:

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54 | Health managers’ modules on Immunization

Section Method (time) Toolj) Waste disposal Demonstration by participants of different wastes

generated and disposal methods (15 mins)Red bag, black bag, hub cutter, twin bucket, disinfectant solution (safety pit: in presentation)

IV. Emergency Management

Exercise: Outline a few possible emergencies in cold chain and then ask the participants to work in small groups of threes and fours and enlist possible emergency situations and what preparations they can plan; make them draw up an emergency plans and present it. (15 mins)

Plain sheets of paper for drawing an emergency plan.

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