checklist - who

CHECKLIST Development and

Implementation of a National Deployment and

Vaccination Plan for Pandemic Influenza

Vaccines

INFLUENZA VACCINE PRODUCTION CAPACITY 2006 TO 2010 iii

Section 1. Management of vaccine deployment operations 4

Section 2. Management of vaccination operations 8

Section 3. Communications and information management for vaccine deployment 11

Section 4. Human resources and security for deployment and vaccination operations 15

Section 5. Public communication 17

Section 6. Supply chain management 19

Section 7. Waste management 23

Section 8. Post-deployment surveillance system and management of adverse events following immunization 27

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Contents

Checklist For assessing and updating National Pandemic Influenza Vaccine Deployment and Vaccination Plan

This checklist is intended for use by officers and authorities at all levels who are in charge of their country’s national deployment and vaccination plan (NDVP) for pandemic influenza vaccine. This checklist highlights critical areas for planning which should be in place before the deployment of pandemic influenza vaccine.

The aim of the checklist is to provide an outline of the essential minimum elements of a national vaccine deployment and vaccination plan. It is recommended that, in countries where planning processes are underway, responsible authorities at all levels consider the specific aspects of the checklist for which they will be or are responsible. Countries that already have an NDVP in place may use the checklist to evaluate and update the current plan.

This checklist should be used in conjunction with a more comprehensive Pandemic Influenza Vaccine Deployment and Vaccination Guidance.

Objectiven To assess the state of a country’s preparedness for deployment and vaccination operations, in

accordance with WHO Guidance on Development and Implementation of a National Deployment and Vaccination Plan for Pandemic Influenza Vaccines.

n To use the checklist as a tool to develop or update a national deployment and vaccination plan.

This checklist is not intended to be comprehensive. Additions and modifications to fit local context are encouraged.

How to use the checklistTo use the checklists effectively, users should:

1. Be familiar with their country’s pandemic influenza preparedness plan (PIPP), their national deployment plan, and in accordance with WHO Guidance on Development and Implementation of a National Deployment and Vaccination Plan for Pandemic Influenza Vaccines.

2. Receive training in the use of the checklists and study each checklist carefully to make sure they understand its overall objective and the purpose of each question.

3. Assure the person being interviewed (hereafter, the interviewee) is the person who is responsible for the activities that the checklist covers.

1

2 DEVELOPMENT AND IMPLEMENTATION OF A NATIONAL DEPLOYMENT AND VACCINATION PLAN FOR PANDEMIC INFLUENZA VACCINES

4. Explain to the interviewee that the purpose of the interview is to improve and support preparedness to deploy a pandemic influenza vaccine at their level within seven days and to vaccinate rapidly thereafter.

5. Explain to the interviewee that their answers will be mainly “yes”, “no” or “do not know”. Those who are being interviewed should be provided with a copy of the checklist. This will limit the need to repeat or reformulate the questions. It should be explained to the interviewee that it is not a problem if they answer “do not know.”

6. If the interviewee does not understand a question, repeat or reformulate the question but do not reword the question to elicit a desired response and be ready to provide feedback to those being interviewed.

7. Have one or two colleagues available to help with questioning. In such a case, the checklist user should explain to the interviewee that they can consult with other colleagues, but only one person can answer.

How to evaluate the resultsTo determine the state of preparedness to deploy pandemic influenza vaccine and implement vaccination operations quickly thereafter, the following are suggested indicators to score and summarize the results of the checklist interviews.

a) Good:

— Answers “yes” to more than 80% of the questions in Sections 1, 2, 3, 4, 5, 7, 8.

— Answers “yes” to 100% of the questions in Checklist 6; that is, all of the questions on logistics.

— “Yes” (or confirmatory data) to all of the questions on the establishment or maintenance of surge capacity.

b) Not good: Anything less than the above.

Checklistn Answer every question unless you are advised to omit a question(s) on the basis of a reply.

n Tick (√) the appropriate box for every question that you answer.

n A “do not know” checkbox is not provided for questions that cannot be answered by “do not know”.

Name and title of the person providing the answers/information for this checklist:

.................................................................................................................................................................................................

.................................................................................................................................................................................................

Name of the establishment: .......................................................................................................................................

Public Private

Name of the locality: ......................................................................................................................................................

Rural Urban

Name of supervisor: .......................................................................................................................................................

Level being checked:

At what level is this checklist being applied? National

State

Provincial

District

Other (specify):

Today’s date: .................................................................. DD/MM/YYYY

Date of last supervisory visit: .................................... DD/MM/YYYY

CHECKLIST 3


Section 1Management of vaccine deployment operations

Management of vaccine deployment operations Yes NoDo not know

1. Have the authorities at your level prepared an pandemic influenza preparedness plan?If the answer is “no” or “do not know”, go directly to question 4 (omit questions 2 and 3).

2. Does the pandemic influenza preparedness plan include a section on the use of a pandemic influenza vaccine?

3. Has an Incident Commander been appointed to be in charge of the overall pandemic preparedness plan?

4. Has a deployment plan for the distribution of pandemic influenza vaccine and ancillary items been prepared?If the answer is “no” or “do not know” check the appropriate box and stop here. You have no further questions to answer in this checklist.

5. Has a Chief of Logistics been appointed to oversee the deployment of pandemic influenza vaccine?

6. Have other government ministries, civil authorities, nongovernmental organizations, the military and/or other institutions and agencies been invited to join and participate in the development of a deployment plan?If the answer is “yes”, please provide a list of the organizations.

7. Are you familiar with the deployment plan for the distribution of pandemic influenza vaccine and ancillary items?If the answer is “no”, check NO and stop here. You have no further questions to answer in this checklist.

8. Has the deployment plan been approved by all organizations and others who will support its implementation?If the answer is “yes”, go to question 10 (omit question 9).

9. By what date will the plan have been approved? DD/MM/YYYY

10. Has a budget been prepared for the deployment plan?If the answer is “yes”, go to question 12 (omit question 11).

11. By what date will the budget be prepared? DD/MM/YYYY

12. Will the deployment plan assure that pandemic influenza vaccine is delivered to all distribution points in seven days?If the answer is “yes”, go to question 24 (omit questions 13–23).

13. What are the five main impediments in the plan to the achievement of this goal?

a)

b)

c)

d)

e)

Management of vaccine deployment operation Yes NoDo not know

14. Have you participated in practice exercises of the deployment activities?If the answer is “yes”, or “do not know” go to question 16 (omit question 15).

15. Explain why there have been no deployment exercises.

16. Has the person or office responsible for the execution of the deployment documented the gaps in requirements for deployment operations?If the answer is “no” or “do not know”, go to question 20 (omit questions 17–19).

17. Has the deployment plan been updated as the result of a gap analysis or exercises (trial runs) of the deployment activities?If the answer is “no” or “do not know”, go to question 20 (omit questions 18–19).

18. Have the gaps in the deployment plan been quantified and organized into specific processes or services such as transportation and information technologies that will provide the support required to achieve the deployment of a pandemic vaccine within seven days?If the answer is “no” or “do not know”, go to question 20 (omit question 19).

19. List the gaps identified and use the “yes”, “no”, “do not know” columns to indicate your reply to whether they will require surge capacity.

a)

b)

c)

d)

e)

f)

g)

h)

20. Have governmental, political, and/or civil authorities been briefed on the existence of the deployment plan for pandemic influenza vaccine?If the answer is “no” or “do not know”, go to question 22 (omit question 21).

21. Have the governmental, political, and/or civil authorities been advised of the gaps and surge requirements?

22. Has any action been taken to secure the additional resources that will be needed to close the gaps in the required surge capacity for deployment?If the answer is “no” or “do not know”, go to question 24 (omit question 23).

23. Does a budget exist that outlines the level of funding required and its sources?

CHECKLIST 5



24. Does the ministry of health have a management information system (MIS)a or similar tool that is able to provide the support required in the planning and execution of deployment of a pandemic influenza vaccine?If the answer is “no” or “do not know”, go to question 27 (omit questions 25–26).

25. Has a dry run using dummy data tested the capability of the MIS to provide the information required to manage and support the deployment plan?If the answer is “no” or “do not know”, go to question 27 (omit question 26).

26. In your opinion and in view of the results of a dry run test, which of the following three statements applies to your situation:

Circle only one answer

a) The MIS can adequately provide the information required to support the deployment of pandemic influenza vaccine to all distribution points in seven days.

b) The MIS requires some modification to adequately provide the information required to support the deployment of pandemic influenza vaccine to all distribution points in seven days.

c) The MIS cannot adequately provide the required information to support the deployment of pandemic influenza vaccine to all distribution points within seven days.

27. Is the protocol for command-and-control explained in a written document?If the answer is “no” or “do not know”, go to question 36 (omit questions 28–35).

28. Have you tested the required operations of the command-and-control structure?

29. Have you developed a schedule of shipments for each distribution point?

30. Have you documented your communications capability to assure that you can receive and send information and/or data within the entire area assigned to you?

31. Have you trained the supervisors who are part of the command-and-control structure?

32. Do you have the resources required to assure effective command and control of the deployment?

33. Do you have a copy of the national deployment plan?

34. Have you coordinated deployment activities with the other distribution points/offices within the area assigned to you?

a The term management information system refers to any system that a) routinely assembles, integrates, processes and/or stores information according to a prescribed set of rules that it receives from the users, units, departments and/or other sources and b) provides this information to management and other users to support their operations. In the simplest form, the information collected is generally driven by the goals and objectives of the users and/or the business or mission of the overall organization.


35. Have you evaluated the compatibility of the command-and -control structure with similar structures at other levels above or below yours to assure that deployment operations can be tracked and supervised?

36. Have you or the responsible office planned for the possibility of the deployment being conducted in two waves if a second dose of vaccine is to be given?

37. Is the person at national or state/provincial level with overall responsibility for the execution of the deployment of pandemic influenza vaccine available to answer the following two questions:If the answer is “yes”, this person is the only one authorized to answer questions 38.If the answer is “no”, check NO and stop here.

Questions on management issues for the person who has overall responsibility for deployment of pandemic influenza vaccine for mass vaccination of the population

38. If the pandemic influenza vaccine were delivered to you today, would you be in a position to distribute it and the ancillary items to all distribution points in seven days?

Explain your answer

CHECKLIST 7


Section 2Management of vaccination operations

Management of vaccination operations Yes NoDo not know

1. Have the authorities at your level prepared a pandemic influenza preparedness plan?If the answer is “no” or “do not know”, go directly to question 4 (omit questions 2 and 3).

2. Does the pandemic influenza preparedness plan include a section on the use of a pandemic influenza vaccine?

3. Has a plan for vaccination operations during a pandemic been prepared?If the answer is “no” or “do not know” check the appropriate box and stop here. You have no further questions to answer in this checklist.

4. Has a Chief of Vaccination been appointed to oversee the vaccination operations?

5. Have other government ministries, civil authorities, nongovernmental organizations, the military, and/or other institutions and agencies been invited to join and participate in the development of a vaccination plan?If the answer is “yes”, please provide a list of the organizations.

6. Are you familiar with the plan for vaccination operations?If the answer is “no”, check NO and stop here. You have no further questions to answer in this checklist.

7. Has the vaccination plan been approved by all organizations and others who will support its operations?

8. Has a budget been prepared for the vaccination plan? If the answer is “yes”, go to question 10 (omit question 9).

9. By what date will the budget have been prepared? DD/MM/YYYY

10. What are the five main impediments in the plan to a successful vaccination campaign?

a)

b)

c)

d)

e)

11. Have you participated in practice exercises ?If the answer is “yes”, or “do not know” go to question 13 (omit question 12).

12. Explain why there have been no vaccination exercises.


13. Has the person or office responsible for the execution of the vaccination operations documented the gaps in requirements for successful operations? If the answer is “no” or “do not know”, go to question 17 (omit questions 14–16 and question 18–19).

14. Has the vaccination plan been updated as the result of a gap analysis or exercises (trial runs) of the deployment activities?

15. Have the gaps in the vaccination plan been quantified and organized into functions, such as information technology, that will provide the support required to achieve rapid vaccination:

16. List the gaps identified – and use the “yes”, “no”, “do not know” columns to indicate your reply to whether they will require surge capacity.

a)

b)

c)

d)

e)

17. Have governmental, political, and/or civil authorities been briefed on the vaccination plan?

18. Have the governmental, political, and/or civil authorities been advised of the gaps and surge requirements for vaccination operations?

19. Has any action been taken to secure the additional resources that will be needed to close the gaps in the required surge capacity for vaccination operations?

20. Is there a budget document outlining the level of funding required and its source?

21. Does the ministry of health or other ministry have a management information system (MIS) that can support vaccination operations?If the answer is “no” or “do not know”, go to question 24 (omit questions 22–23).

22. Has there been a dry run using dummy data to test the capability of the MIS to provide the information required to manage and support vaccination operations? If the answer is “no” or “do not know”, go to question 24 (omit question 23).

23. In your opinion and in view of the results of the dummy data tests, which of the following three statements applies to your situation:

a) The MIS can adequately provide the information required to support the vaccination operations?

b) The MIS requires some modification to adequately provide the information required to support the vaccination operations?

c) The MIS cannot adequately provide the required information to support the vaccination operations?

CHECKLIST 9



24. Is the protocol for command-and-control explained in a written document?

25. Have you documented your communications capability to ensure that you can receive and send information and/or data within the entire area assigned to you?

26. Have you trained the supervisors who are part of the command-and-control structure?

27. Do you have a copy of the national deployment plan?

28. Have you coordinated deployment activities with the CoL or similar counterpart within the area assigned to you?

29. Have you evaluated the compatibility of the command-and-control structure with similar structures at other levels (above or below yours) to ensure that vaccination operations can be tracked and supervised?

30. Have you or the responsible office planned for the possibility of the vaccination operations being conducted in two waves if a second dose of vaccine is to be given?

31. Is the person at national or state/provincial level with overall responsibility for vaccination operations available to answer the following question.If the answer is “yes”, this person is the only person authorized to answer questions 32. If the answer is “no”, check NO and stop here.

32. If the pandemic influenza vaccine were delivered to you today, would you be in a position to begin vaccination operations immediately? If not, in how many days?

Explain your answer

Section 3Communications and information management for vaccine deployment

Communications and information management for vaccine deployment Yes NoDo not know

1. What type of inventory management system (IMS)a do you have for tracking the reception, storage, and distribution of batches of vaccines and ancillary items?

Circle a) or b) or both.

a) Manual

b) electronic/computer-based

2. How do you send information (on reception, storage, and distribution) from your IMS system?

Circle all that apply

a) Via the post office

b) Electronically by computer using software such as Microsoft Excel

c) Via the Internet

d) Other; specify:

3. a) Have you or the Incident Commander mapped out critical decisions to resolve potential problems that could arise during the deployment of vaccine, ancillary devices, or other pharmaceuticals during an influenza pandemic?

b) Has this mapping been done at all levels?

4. Have you or the responsible office determined the critical components of information that will need to be sent up and down the information channels in order to monitor deployment activities and provide information to decision makers?If the answer is “no” or “do not know”, go to question 7 (omit questions 5–6).

5. Have you or the responsible office evaluated the capability of the current management information system (MIS)b to provide the critical information required during the deployment of pandemic influenza vaccine in seven days?

6. Have you or the responsible office evaluated the capability of the IMS to provide the critical information required to support the deployment of pandemic influenza vaccine in seven days?

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CHECKLIST 11

a An inventory management system (IMS) is an active control programme that provides information on the quantities, status, and location of stocks within a store or warehouse to assist in the management of related activities such as ordering, receipt, filling requests, and/or shipping/onforwarding these items. The IMS tools available today support many functions including, but not limited to, automated billing (accounts receivable) and the issue of authorization to pay suppliers.

b The term management information system refers to any system that a) routinely assembles, integrates, processes and/or stores information according to a prescribed set of rules that it receive from the users, units, departments and/or other sources and b) provides this information to management and other users to support their operations. In the simplest form, the information collected is generally driven by the goals and objectives of the users and/or the business or mission of the overall organization.



7. In your opinion, what is the gap between the current capability of your systems and the capability required?

Circle only one answer

a) Significant (large)

b) Moderate (not so large)

c) Non-existent (there is no gap)

d) If there is no gap, go to question 10 (omit questions 8 and 9).

8. Have you consulted the office that deals with information technology (IT) and/or your superiors to determine what will be required to upgrade or modify the existing MIS and IMS so they meet the deployment requirements?If the answer is “no”, go to question 10 (omit question 9).

9. Is there an approved budget to cover the cost of upgrading and/or purchasing the computer software that may be required to ensure that these systems (IMS and MIS) meet the deployment requirements?

10. Has a data-quality audit been conducted within the last two years? Answer this question whether the IMS is manual or computer-based.If the answer is “no” or “do not know”, go to question 15 (omit questions 11–14).

11. Did the data-quality audit identify any problems?If the answer is “no” or “do not know”, go to question 15 (omit questions 12–14).

12. Describe the five major problems identified by the data-quality audit?

a)

b)

c)

d)

e)

13. Has any action been taken to correct the above problems?If the answer is “no” or “do not know”, go to question 15 (omit question 14).

14. Describe the action taken to correct the problems.

a)

b)

c)

15. Is there a listing – either a map or a document – with details of the different communication systems and equipment and their respective owners/users in the government (i.e. the different ministries and departments such as the police and army)?If the answer is “no” or “do not know”, go to question 18 (omit question 16–17).


16. How many different communication systemsa exist in the country or at your level?If the answer is “0” or “do not know”, go to question 18 (omit question 17).

(number)

17. How many of these systems can communicate (send and receive information) with each other without the need to change equipment? (number)

18. Regardless of the current problems with information exchange, could a combination of all the systems in use by the different government agencies and private companies provide overall geographical coverage for the communications required in all parts of the country and/or region that you work in?

19. If private contractors will be used, have you or the responsible office confirmed their ability to communicate with all parts of the country or region that they will serve?

20. Has the ministry of health or the appropriate office prepared a plan with other government ministries (including the police and army) to coordinate communications in the event of a deployment of pandemic influenza vaccine?

21. What percent of the public or government-owned fleet of motorized transport has radios and/or cell phones to communicate with the office(s) they have been assigned to serve?

%

22. What percentage of the private-sector fleet of motorized transport that has been or will be contracted has radio or cell phones to communicate with the office(s) they are assigned to serve?

%

23. In your opinion, would it be advantageous to be able to communicate with the transport team that is delivering the pandemic influenza vaccine to distribution points during the deployment?

24. Have you or the office responsible for communications and information conducted exercises to test the capacity of the respective communications systems to provide information on a daily basis?If the answer is “no” or “do not know”, go to question 28 (omit questions 25–27).

25. Describe the five major problems identified during the exercises.

a)

b)

c)

d)

e)

26. Has action been taken (or planned) to correct these problems?If the answer is “no” or “do not know”, go to question 28 (omit question 27).

CHECKLIST 13

a Telecommunication systems can be public, private, government specific, e.g., military/forestry.



27. Describe the action that has been taken to correct the problems

28. Have you or the responsible office identified the type of information that should be communicated to the public concerning the deployment operations?

Write name of office:

29. Will it be necessary to plan surge capacity to ensure that the Incident Commander and the Chief of Logistics can communicate with all levels?If the answer is “no” or “do not know”, go to question 32 (omit questions 30 and 31).

30. Is there a written communications plan outlining the requirements to ensure surge capacity?If the answer is “no” or “do not know”, go to question 32 (omit question 31).

31. Is there an approved budget to cover the cost of surge capacity to support communications?

32. Has a back-up plan been drawn up in case there is a major disruption to existing communications – cell phones, fixed (land-line) phones, or the Internet?

Section 4Human resources and security for deployment and vaccination operations

Human resource and security for vaccine deployment Yes NoDo not know

1. Has your office determined how many people under your responsibility will be required to deploy the pandemic influenza vaccine to designated distribution points in seven days?If the answer is “no” or “do not know”, check the appropriate box and stop here. There are no further questions for you to answer in this checklist.

2. Is there a list of the type of staff (in terms of skills) needed for deployment of pandemic influenza vaccine?If the answer is “no” or “do not know”, check the appropriate box and stop here. There are no further questions for you to answer in this checklist.

3. Does the list include terms of reference or job descriptions for each post?

4. Do the skills of current staff members who could be assigned to support the deployment match the skills of the posts required?If the answer is “yes”, go to question 6 (omit question 5).

5. What plans have been made to match the skills of current staff with the skills that will required by each post during the deployment?

6. Are you familiar with the three types of job aid that can be used?If the answer is “no”, go to question 8 (omit question 7).

7. Do you consider that job aids will be useful in ensuring staff understand the tasks required of them during the deployment?

8. How will you ensure that each staff member involved in the deployment will execute his or her tasks according to their terms of reference?

CHECKLIST 15


Human resource and security for vaccine deployment Yes NoDo not know

9. Do you have plans for updating and retraining current and new staff to perform their tasks during the deployment?

10. Have all potential partners that will provide staff to support the deployment been notified of the skills expected of their staff?

11. Have plans been made to train staff from partner agencies to ensure that each person can perform the tasks outlined in his/her terms of reference?If the answer is “no” or “do not know”, go to question 13 (omit question 12).

12. Have funds been allotted for planned training?

13. Have the current supervisors been given training for the seven-day deployment?

14. Are there sufficient supervisors to cover the hard-to-reach areas?

15. Do all supervisors have the funds, transportation, and communication equipment that they will require to support their respective tasks during the deployment?

16. Have you or the responsible office estimated the recurrent costs of providing training and/or updating staff over the next five years with respect to their deployment activities?

17. Does the pandemic influenza preparedness plan for your country state that health staff will be among the first to be vaccinated?

18. Is there a written plan on how to ensure the security of staff during an emergency or major campaign? (This can be a general plan related to diverse situations or a specific plan drawn up for pandemic influenza activities.)

19. Does the pandemic influenza preparedness plan affirm that health staff will be given anti-virals if they are diagnosed with pandemic influenza or consider that they have been infected with the virus?

20. Does the pandemic influenza preparedness plan state that you or the responsible office will identify the high risk areas where additional security measures, such as the assignment of security personnel, will be required?

21. In your opinion, are there sufficient supervisors to support the number of staff required for deployment of the vaccine and to solve problems that may arise during this time?

Section 5Public communication

Questions on management of public communication Yes NoDo not know

1. Are you the person responsible for preparing the public communication plan in support of the next influenza pandemic?If the answer is ‘no’, STOP here. You are done. You must find the person responsible for preparing the public communication plan to proceed with this questionnaire.

2. Is there a written public communication plan for generating demand for the pandemic influenza vaccine – either as a component of your pandemic preparedness plan or as a stand-alone document?If the answer is “no” or “do not know”, go directly to question 13 (omit questions 3 to 12).

3. Does the plan include activities for the periods before, during, and after pandemic influenza vaccine deployment?

4. Which office is responsible for preparing and disseminating the plan?

5. Is there an approved budget to cover the costs of drafting, implementing, monitoring, and evaluating the plan?

6. Does the communication plan incorporate specific messages to reach target groups?

7. Does the communication plan spell out how to reach target groups?

8. Does the plan identify a key spokesperson, or a group of individuals, responsible for communicating with media and partners at the

a) National Level

b) Regional Level

c) Local Level

9. Have you planned to conduct any formative research or rapid assessment to help you develop your campaign messages and choice of communication channels?

10. Does the communication plan consider mass media channels of communication?

11. Does the communication plan consider interpersonal channels of communication?

12. Have you planned for monitoring media coverage?

13. Do you plan to evaluate how your campaign(s) has(have) influenced the behaviours of the general public and priority target groups towards uptake of the pandemic influenza vaccine?

CHECKLIST 17


Questions on management of public communication Yes NoDo not know

14. What are the five main impediments to preparing a plan to support public communication activities?

a)

b)

c)

d)

e)

15. What are the lessons learned from the public communication efforts undertaken in support of the vaccination of targets groups using the 2009 pandemic influenza pandemic?

Section 6Supply chain management

Supply chain management Yes NoDo not know

1. Has a Chief of Logistics been appointed for the deployment of pandemic influenza vaccine?

2. Has the Chief of Logistics or another person prepared a plan for the deployment of a pandemic influenza vaccine? If the answer is “no” or “do not know” check the appropriate box and stop here. There are no further questions for you to answer in this checklist.

3. Has the deployment plan been approved by the required person(s) or committee(s)? If the answer is “no” or “do not know”, go to question 5 (omit question 4).

4. How much of the estimated budget to support the deployment plan has been secured? Tick (√) YES. Choose only one answer:

a) The entire budget has been secured

b) Almost all of the budget has been secured

c) About half of the budget has been secured

d) Very little of the budget has been secured

e) None of the budget has been secured

f) Do not know

5. Has the Chief of Logistics mapped out the flow of vaccine and ancillary items? If the answer is “no” or “do not know”, go to question 8 (omit questions 6 and 7).

6. Has the transportation network been mapped out at your level and/or for the country?

7. Have the gaps in transportation (vehicles) been recorded at each level?

8. Have the gaps or the need for surge capacity for transportation been presented to other government ministries, the military, the police, civil authorities, and/or nongovernmental organizations for their consideration? If the answer is “yes”, go to question 10 (omit question 9).If the answer is “do not know”, go to question 11 (omit questions 9 and 10).

9. Indicate the date by when this will be done.(Go to question 11; omit question 10.) DD/MM/YYYY

10. What percent of the:

a) gaps have been closed a) .......... %

b) required surge capacity has been established or planned for? b) .......... %

CHECKLIST 19



11. Has there been a review to ensure that each health establishment that will store vaccines and associated ancillary items (syringes etc.) uses the same inventory management system (IMS)?a

If the answer is “yes”, go to question 13 (omit question 12). If the answer is “do not know”, go to question 15 (omit questions 12–14).Note: Questions 13, 14, 15 and 16 also apply to private-sector storage facilities that have been contracted to provide storage.

12. Indicate the date when the IMS will be reviewed.(Omit questions 13–14 and go to question 15.) DD/MM/YYYY

13. In your area of responsibility, what percentage of health establishments or service providers using the same IMS can:

a) trackb receipt of vaccines and ancillary items? a) .......... %

b) record onward dispatches to their clients/other establishments using the same management inventory system? b) .......... %

14. In your area of responsibility, what percentage of the health establishments or service providers using the same IMS can provide the information listed in question 13:

a) within four hours? a) .......... %

b) within 12 hours? b) .......... %

15. In your area of responsibility, what percentage of the health establishments or service providers can provide this information using the same reporting formats?

............ %

16. In your area of responsibility, what percentage of health establishments or service providers have sufficient cold boxes or containers to achieve deployment of pandemic influenza vaccine to all distribution points within seven days if all the population was offered vaccination?

............ %

17. Have the cold boxes and/or containers been inspected to determine whether they are in a suitable condition to be used in the deployment of pandemic influenza vaccine?

18. What percent of the cold boxes/containers can maintain the specified cold lifec while transporting pandemic influenza vaccine? ............ %

19. Have the cold rooms/stores that store large quantities of vaccines been inspected within the last two years? If the answer is “no” or “do not know”, go to question 24 (omit questions 20–23).

a An inventory management system (IMS) is an active control programme that provides information on the quantities, status and location of stocks within a store or warehouse to assist in the management of related activities such as ordering, receipt, filling requests and/or shipping/onforwarding these items. The IMS tools available today support many functions including – but not limited to – automated billing (accounts receivable) and the issue of authorization to pay suppliers.

b The term track refers to the ability to provide dates, batch numbers, number of doses, number of containers received, and condition on arrival, as appropriate for vaccines, syringes, and ancillary items.

c Cold life refers to the number of hours that a cold box or container, correctly packed with cold packs or ice, will keep pandemic influenza vaccine between 0 °C and +10 °C (not above +10 °C and not below 0 °C) at local ambient temperatures.

Supply Chain chain management Yes NoDo not know

20. How many cold rooms/stores have been inspected per question 19? (Give the number.) ................ (number)

21. What percentage of the cold rooms/stores have functional IMS to control stocks of vaccine and other related items used for the parenteral administration of vaccine?

............ %

22. What percentage of the warehouses where large quantities of vaccines are being stored have automatic back-up generators for their cold rooms or stores?

............ %

23. What percentage of the cold rooms are equipped with automatic temperature recorders? ............ %

24. Does the existing deployment and vaccination plan include the following data and information:

a) Quantities/volumes of vaccine and ancillary items that must be shipped to each distribution point.

b) Estimated amount of medical waste generated during deployment that will need to be collected and transported to a disposal site.

c) Quantities of cold boxes and/or other containers for delivering the vaccines and ancillary items to each site.

d) List of warehouses/cold storerooms at all levels and their estimated capacities to temporarily store vaccine and ancillary.

e) List of distributions sites classified by type of transport to be used.

f) Illustrative schedule of times and dates for the dispatch of each vaccine consignment, including the required ancillary items.

g) Estimated surge capacities to support the following activities:

i) Transportation

ii) Waste management

iii) Storage facilities for large quantities of vaccines and ancillary items

iv) Supervisory activities (transport/per diem/additional staff/communication hardware) (To answer “yes” all items must be stated in the plan.)

v) Communications hardware

vi) Estimated budget to support the required surge activities

vii) List establishments and the quantities of vaccines and ancillary items to be repacked and forwarded to the next distribution point.

Does this list included the estimated number of staff required to complete the repacking and labeling of shipping boxes and cold boxes?

25. Has your office or any other responsible entity carried out any exercises to test or practice deployment activities?

CHECKLIST 21



26. What was the date of the last exercise? YYYY/MM/DD

27. Summarize the five most important gaps identified during the last exercise of deployment activities.

Please provide a copy of the exercise report.

a)

b)

c)

d)

e)

Section 7Waste management

Waste management Yes NoDo not know

1. Is there a national and/or local policy on the proper disposal of health-care waste with specific instructions on the disposal of used syringes and needles? If the answer is “no” or “do not know”, check the appropriate box and stop here. You have no further questions to answer in this checklist.

2. Has there been an assessment of the extent of implementation of this policy in all the health establishments and/or service providers? If the answer is “no” or “do not know” go to question 5 (omit questions 3 and 4).

3. Have you received a copy of the assessment report? If the answer is “no” or “do not know” go to question 5 (omit question 4).

4. Has your office or the office responsible for the management of health-care waste carried out follow-up visits to discuss or implement the recommendations in the assessment report or to review subsequent compliance with the waste-disposal policies? If the answer is “yes”, go to question 6 (omit question 5). If the answer is “do not know”, go to question 7 (omit questions 5 and 6).If the answer is “no”, go to question 5 (omit question 6).

5. What are the reasons for the lack of follow up? Tick (√) the all that apply below:

No funds have been assigned for this activity

Lack of personnel

Lack of transport

Further instruction or information from a superior level is required

Recommendations in the assessment report were not sufficiently explicit

Other. Please explain:

6. In the last 24 months, what percentage of the establishments or service providers you are responsible for have had their waste management practices assessed?

............ %

7. Are you familiar with the pandemic influenza preparedness plan for your country?

8. Has your office or the office that manages the medical waste generated by the health services estimated the volumes of medical waste that will need to be processed per week during mass vaccination of the population in the event of an influenza pandemic?If the answer is “no” or “do not know”, go to question 11 (omit question 9 and 10).

CHECKLIST 23



9. Do the current waste facilities in your area/country have the capacity to process in one week all the medical waste that will be sent to disposal sites in the event of mass vaccination of the population against pandemic influenza? If the answer is “yes” or “do not know”, go to question 11 (omit question 10).

10. Have plans been made to address the shortage of facilities and/or lack of capacity to process the volumes of medical waste that will be generated in the event of mass vaccination of the population?

11. Has the office responsible for planning surge capacity drafted a plan for medical waste disposal in the event of mass vaccination of the population? If the answer is “no” or “do not know”, go to question 13 (omit question 12).

12. Have the funds for the items/activities required to provide surge capacity been approved?

13. Which of the methods of disposal of contaminated injection waste, listed below, are used most frequently in your area/country? Tick (√) the method/s used by area

Incineration (private or public) Urban Rural

Local or open-pit burning Urban Rural

Buried Urban Rural

Municipal-waste services Urban Rural

Latrine pits Urban Rural

14. Is there a directory listing or a map that shows the medical waste disposal facilities that comply with national norms and specifications at each level?

15. In the last two years, what percentage of the medical waste facilities in your area have been inspected? (If the answer is “none”, enter zero.) ............ %

16. What percent of the medical waste facilities in your area are private enterprises? If the answer is “0” or “do not know”, go to question 20 (omit questions 17–19).

............ %

17. How many contracts with private medical waste companies are in place for the collection of routine medical waste from your health-care service providers?

................ (number)

18. What percentage of these contracts have a clause to cover the provision of surge capacity to deal with the huge amounts of waste products that will be generated during mass immunization of the population against pandemic influenza? (If the answer is “none”, enter zero.)

............ %

19. What percentage of the contracted private medical waste facilities have been inspected within the last two years? ............ %

What percentage of these facilities passed the inspection? ............ %


20. In your area, how many of the medical waste facilities are public-sector enterprises? (enter number)If the answer is “0” or “do not know”, go to question 23 (omit questions 21–22).

................ (number)

21. What percent of public-sector facilities have prepared plans for surge capacity to deal with the additional medical waste that will be generated during a mass vaccination campaign?

............ %

22. What percent of public-sector medical waste facilities have been inspected within the last two years? ............ %

What percent of the public sector medical waste facilities passed the inspection? ............ %

23. Has the management information system (MIS)a and/or inventory management system (IMS)b been updated to include relevant data for all the medical waste facilities, including the assignment of each health service to a particular facility in the country/level?

[Note: This question is only relevant if the person replying to these questions is from an establishment that is responsible for the organization and execution of medical waste procedures for one or more health-service providers in the country at state, provincial, and/or district levels.]

If the answer is “yes” or “do not know”, go to question 25 (omit question 24).

24. Why have these systems not been updated? Tick (√) all answers that apply.

The MIS and/or the IMS do not permit this type of information to be entered

The staff have not been instructed to update the systems

The staff are not responsible for this activity

Other. Please specify:

25. During any previous immunization campaigns have there been any problems with the safe disposal of contaminated injection equipment within the period of one week? If the answer is “no” or “do not know”, go to question 27 (omit question 26).

CHECKLIST 25

a The term “management information system” refers to any system that a) routinely assembles, integrates, processes and/or stores information according to a prescribed set of rules that it receive from the users, units, departments and/or other sources, and b) provides this information to management and other users to support their operations. In the simplest form, the information collected is generally driven by the goals and objectives of the users and/or the business or mission of the overall organization.

b An inventory management system (IMS) is an active control programme that provides information on the quantities, status and location of stocks within a store or warehouse to assist in the management of related activities such as ordering, receipt, filling requests and/or shipping/on forwarding these items. The IMS tools available today support many functions including, but not limited to, automated billing (accounts receivable) and the issue of authorization to pay suppliers.



26. If yes, what caused the problems? Please specify whether the problems were in urban areas, rural areas or both. Tick (√) all answers that apply for your area.

Lack of access to other waste disposal facilities Urban Rural

Lack of transport to take injection waste to facility Urban Rural

Equipment not working Urban Rural

Lack of funds to pay for transport Urban Rural

Lack funds to cover services of a private contractor Urban Rural

Other; specify. Urban Rural

27. Are you familiar with the WHO document Management of waste from injection activities at district level – Guidelines for district health managers? If the answer is “no” or “do not know”, go to question 30 (omit question 28 and 29).

28. Are there copies (or a copy) of this document available in your country or at your level? If the answer is “no” or “do not know”, check the appropriate box and stop here. There are no further questions for you to answer in this checklist.

29. Have you assessed the compliance of your office or your service providers with the WHO recommendations contained in this document or with the national norms and policies on the management of injection waste? If the answer is “no” or “do not know”, check the appropriate box and stop here. There are no further questions for you to answer in this checklist.

30. Do your health services comply with the written medical waste disposal norms and policies? If the answer is “yes” or “do not know”, check the appropriate box and stop. There are no further questions for you to answer in this checklist.

31. What are the problems with compliance and the major reasons for them?

Describe them below.

Section 8Post-deployment surveillance system and management of adverse events following immunization

Post-deployment surveillance system and management of adverse events following immunization

Yes NoDo not know

1. Guidelines and procedures for monitoring and management of adverse events following immunization (AEFI) have been published and are available to all staff at all levels involved in vaccine related AEFI?

2. Do the guidelines or other documents for managing AEFIs spell out the roles and responsibilities for the following offices:

a) National immunization programme

b) National regulatory authority (NRA)

c) Disease surveillance staff

d) Pharmacovigilance AEFI staff

3. At your level is there a training budget to support yearly training and information activities AEFI monitoring and management for staff responsible for post-deployment surveillance (PDS)/AEFI systems?

4. Is specific information/documents on seasonal influenza vaccine and associated AEFIs provided to all staff on a yearly basis?

5. Is AEFI data is compiled, analysed, and interpreted within a month or less after a case is reported and investigated?

6. Is information on serious cases and AEFI clusters and investigation reports on any vaccine-related AEFI shared between the NRA, national immunization programme, disease surveillance, and pharmacovigilance staff?

7. Did you receive any documentation summarizing the AEFI’s reported in association with the use of the vaccine for pandemic influenza A(H1N1) 2009?

8. Has the capacity to detect and investigate significant vaccine safety issues been exercised?

9. Does the programme responsible for managing AEFIs surveillance system provide the following information:

a) Semi annual reports on AEFI?

b) Reporting AEFI rate by each vaccine, including seasonal influenza, if used in your country?

c) Reports by type of AEFI, age group, geographical region?

CHECKLIST 27


Post-deployment surveillance system and management of adverse events following immunization

Yes NoDo not know

10. Please provide the percentage of AEFI reports that:

a) Are submitted in a timely manner and according to established norms?

b) Comply with established guidelines and/or standard operating procedures?

c) Comply with the protocols for carrying out an investigation?

d) Are accessiblea to laboratory and toxicity testing and immunization personnel?

11. Are protocols published and disseminated to guide action to measure vaccine performance/efficacy?

12. Are there documented procedures in place for corrective/regulatory action?

13. Do the marketing authorization (MA) process procedures for licensing a novel pandemic influenza vaccine included post-deployment safety monitoring?

14. When licensing a novel pandemic influenza vaccine, does the NRA require the MA holder to perform a specific study of safety in the post marketing period?

15. Does the NRA require all manufacturers to inform it of any new safety issues or marketing/regulatory decisions taken in other countries with respect to seasonal influenza vaccine or strain-specific pandemic influenza vaccine?

16. Are there written procedures in place for stopping and recalling a pandemic influenza vaccine should the AEFI or PDS evidence warrant this decision?

17. At your level, has an estimated budget been included either in the pandemic influenza preparedness plan (PIPP) or the national deployment and vaccination plan (NDVP) for supporting investigation and laboratory activities to reported AEFIs when using a strain-specific pandemic influenza vaccine?

Is this estimated budget sufficient?

a Accessible is defined as: Website, or Emails, or printed reports

checklist - who

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