Technical Assistance Guidelines.doc

Technical Assistance Guidelines

H1N1 Influenza Mass Vaccination Campaign

Version 4.0July 2009

Florida Department of Health

Table of Contents

I. INTRODUCTION____________________________________________________________________1

II. ORGANIZATION, ROLES AND PURPOSE_______________________________________________1

A. Introduction___________________________________________________________________1

B. Goal_________________________________________________________________________1

C. Length of the Plan______________________________________________________________1

D. Responsibilities: Department of Health (Central Office)_______________________________1

E. Responsibilities: County Health Departments_______________________________________2

F. Responsibilities: County Health Department Partners________________________________3

III. MANAGEMENT OF A MASS VACCINATION CAMPAIGN_____________________________4

IV. VACCINE MANAGEMENT___________________________________________________________5

A. General Information____________________________________________________________5

B. Flow of Influenza Vaccine to Vaccination Clinic Locations____________________________6

C. Ordering Influenza Vaccine_______________________________________________________6

D. Vaccine Shipping Information____________________________________________________6

E. Storage and Handling___________________________________________________________8

F. Vaccine Security_______________________________________________________________8

G. Disposal of Empty, Wasted or Expired Vials________________________________________8

H. Returning/Reallocating Vaccine to Central Pharmacy or CHDs________________________9

V. VACCINATION CLINIC OPERATIONS_________________________________________________10

A. General Information___________________________________________________________10

B. Recruitment__________________________________________________________________10

C. Vaccination Scheduling________________________________________________________10

D. Registration__________________________________________________________________11

E. Medical Screening_____________________________________________________________11

F. Vaccination Station____________________________________________________________12

G. Exit Review__________________________________________________________________13

VI. ADVERSE EVENT MANAGEMENT AND REPORTING____________________________________14

A. Adverse Event Medical Management_____________________________________________14

B. Adverse Event Reporting_______________________________________________________15

VII. SAFETY________________________________________________________________________17

A. Clinical and Ethical Safeguards__________________________________________________17

VIII. COMMUNICATIONS______________________________________________________________17

A. Communications Flow, Support and Management__________________________________17

B. Communications Tracks_______________________________________________________18

IX. REPORTING AND DATA MANAGEMENT______________________________________________19

A. Immunization Registry_________________________________________________________19

Technical Assistance Guidelines ► i


B. Reports_____________________________________________________________________19

X. FUNDING AND STAFF RESOURCES__________________________________________________20

A. Expenditures of Pre-event and Post-event Vaccination______________________________20

B. Department of Health, Human Resource Management_______________________________20

C. Healthcare Partner Agencies____________________________________________________23

XI. Key Terms_______________________________________________________________________24

Appendix A- Planning Scenarios_______________________________________________________27

Appendix B- Planning Assessment Checklist____________________________________________30

Appendix C- Large Scale Clinic Supply List________________________________________________34

Technical Assistance Guidelines ► ii


I. INTRODUCTIONHIN1 Influenza Mass Vaccination Campaign is a three-stage program to prepare the health care community and protect Floridians against the threat of influenza. This initiative will provide influenza vaccinations on a voluntary basis, to persons in Florida as defined by federal priority group guidance. (See Appendix A for the latest planning scenarios suggesting the current priority groups based on existing virus epidemiology) The three stages of this initiative are:

Stage I- those individuals identified as priority groups in Tier I; Stage II- those individuals as priority groups in Tier II; and Stage III- general population as directed by federal guidance.

The goal of Stages I and II of the H1N1 Influenza Mass Vaccination Campaign is to reduce the burden on systems and to reduce excess morbidity and mortality. This Technical Assistance Guideline is a resource for County Health Department program staff responsible for implementing H1N1 Influenza Mass Vaccination Campaign in their jurisdiction. Staff will provide influenza vaccinations in accordance with current recommendations of the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP).

These Technical Assistance Guidelines will be maintained on-line at <insert link> and updated as needed. The latest federal guidance is available on the Department of Health and Human Services site at www.flu.gov.

II. ORGANIZATION, ROLES AND PURPOSE The State Surgeon General of the Florida Department of Health is responsible for ensuring implementation of the H1N1 Influenza Mass Vaccination Campaign. The County Health Department Director/Administrator is responsible for implementing the H1N1 Influenza Mass Vaccination Campaign within their respective county.

A. IntroductionThe H1N1 Influenza Mass Vaccination Campaign uses as its foundation the core components of vaccination programs provided by the public and private sectors. This program will continue until this novel strain of influenza can be incorporated into the traditional trivalent influenza preparations and become part of routine preventive healthcare.

B. GoalThe goal of this effort is to vaccinate all Floridians who choose to be vaccinated in accordance with designated federal guidance and in the appropriate time sequence.

C. Length of the PlanVaccination of the Stage I individuals is anticipated to be accomplished within one month upon receipt of the vaccine. Subsequent vaccination of Stage II and Stage III individuals with their first dose is anticipated to be accomplished within two months of receipt of adequate supplies of vaccine. Current guidance is that vaccinated individuals will need to receive a second dose approximately 21-28 days after the first dose, so planning needs to include this requirement.

D. Responsibilities: Department of Health (Central Office)Central Office will: take the lead in policy development; collaboration with state and national partners; serve as a clearinghouse for educational and technical materials; supply vaccine and vaccination supplies; establish data management standards; develop technical assistance guidance and provide consultation. Central Office staff will be responsible for the following:

1. Vaccine Management: Provide influenza vaccine to 67 CHDs and healthcare partners as identified. This includes shipping vaccines to designated sites following national guidelines as

Technical Assistance Guidelines ► 1

http://www.flu.gov/


well as monitoring vaccine accountability and ensuring that national reporting requirements are met.

2. Education: Develop appropriate messaging, training, and associated educational materials for distribution to CHDs.

3. Vaccination: Ensure that all CHDs have the necessary plans in place to provide mass vaccinations.

4. Reporting: Continue to utilize the adverse event monitoring system established for all vaccinations provided in the state. Collect doses administered in Florida SHOTS and report to the CDC’s Countermeasure Response Administration System weekly during campaign.

E. Responsibilities: County Health DepartmentsThe CHDs, in coordination with Children’s Medical Services, hospitals, healthcare systems, private medical community, and select other partners will provide training, vaccination services, coordination with local law enforcement, fire rescue, EMS (paramedics/EMTs), and other partners to ensure influenza vaccination activities are completed in accordance with federal guidance. (See Appendix B for a Planning Assessment Checklist)

1. Reach out to the designated Tier priority groups in their communities. Ensure that all designated priority groups are contacted and briefed on the overall

purpose, operation management and time line for successful completion of the campaign.

Establish communication channels and points of contacts (POC) with all designated priority groups targeted for vaccination.

Ensure that pre-event messaging is appropriately disseminated to priority populations and general public to reduce confusion in the community on the campaign and its implementation.

2. Determine what groups have capacity to vaccinate themselves and which groups need to be vaccinated by the CHD.

Ensure that these groups understand the process for establishing an account in Florida SHOTS for data reporting efforts.

3. Provide education and training to ensure providers and potential vaccinees are informed and understand roles and responsibilities.

Provide educational information to support activities to be conducted to points of contact (POC).

Provide information to assist potential vaccinees in making an informed decision.

Assist each provider in developing a system for prescreening potential vaccinees designed to exclude those persons with contraindications to the vaccine.

Coordinate training and education to identified potential vaccinees on the benefits, risks, contraindications and procedures for the influenza vaccination.

Develop a streamlined process to ensure that all community partners who assist in the vaccinating process are registered Florida SHOTS users with appropriate accounts established for reporting doses administered.

Provide guidance on utilization of Florida SHOTS for recording vaccinee’s information. If the provider is not able to access Florida SHOTS, then a process for recording vaccinee’s information for subsequent transfer to the CHD needs to be developed.



Obtain a list of potential vaccinees from each group that will be vaccinated by the CHD.

The CHDs will also be responsible for providing training to EMTs, paramedics and other licensed personnel that may be assisting with vaccinations as indicated.

4. Vaccinate according to the designated priority groups. Review the list of prescreened potential vaccinees by site to design a vaccination

schedule that will be completed within the month for those in Tier 1 priority groups and ensures efficiency and safety.

Designate appropriate clinic sites. It is appropriate to utilize the same types of clinic sites used for seasonal influenza vaccination. However, the POD sites identified in respective SNS plans are suitable as well as school-based clinics.

Develop a clinic schedule that can optimize priority group utilization.

Receive the vaccine from the central pharmacy or designated site.

Ensure vaccine receipt is properly entered into Florida SHOTS prior to administering doses.

Ensure required supplies are on-hand in sufficient quantities to support the number of persons to be vaccinated.

Ensure the security of the vaccine.

Staff and logistically support the vaccination clinics.

As time and resources allow, run reminder/recall reports from Florida SHOTS to generate lists of vaccinees who need to receive the second dose of vaccine to ensure complete protection. Contact vaccinees for return to clinics for second dose.

5. Monitor for adverse events occurring after vaccination. Ensure that each vaccinee has 24/7 access to report medical concerns, to triage of

adverse reactions and to a hospital-based physician for medical evaluations to discuss medical concerns and appropriate care of adverse reactions.

Ensure reporting of adverse events to the State VAERS Coordinator and through the VAERS system.

Report all adverse events daily using the VAERS System and report to the state VAERS coordinator.

6. Ensure that doses administered are entered into Florida SHOTS on a timely basis for documentation of doses administered, inventory accountability and reporting to the CDC CRA system weekly.

F. Responsibilities: County Health Department PartnersFor the purposes of H1N1 Influenza Mass Vaccination Campaign, CHD partners include hospitals and other healthcare partners, EMS, fire rescue and law enforcement including correctional facilities.

1. Education The partners will provide training to their membership on the influenza disease,

vaccine, contraindications, and potential adverse events.



2. Vaccination Paramedics and EMTs may be utilized by CHDs as needed to assist in vaccinations.

Paramedics can assist CHD with vaccinations if both mutually agree and follow procedures outlined in sections 401.272, Florida Statutes, and 64E-2.004, Florida Administrative Code.

3. Monitoring The partners will be responsible for contact with their vaccinees and will monitor

participants for potential adverse events.

4. Resources Utilize CHDs resources to ensure the completion of the H1N1 Influenza Mass

Vaccination Campaign.

5. Reporting Each partner will establish an account in Florida SHOTS and enter all doses

administered for this effort into the system.

The H1N1 Influenza Mass Vaccination Campaign will continue to ensure hospitals and other healthcare providers from Stage I participate in order to protect their staff and be prepared to respond to an increase in H1N1 Influenza patients. As partners in this preparedness effort, hospitals and other providers in the healthcare community may choose their level of participation—a) receive vaccine from the CHD and provide vaccinations to their staff, or b) coordinate with the CHD for their staff to be vaccinated at CHD-coordinated clinics. It is recommended that CHDs facilitate these partners’ ability to provide vaccinations to their staff in order to reduce the burden on CHD clinics. These partners will be subject to the same responsibilities indicated in F above as it pertains to their organization. Reporting to Florida SHOTS will be required. These partner facilities may establish accounts in Florida SHOTS in order to pre-register patients for vaccination at the CHD. The CHD will then update the pre-registered patient with H1N1 vaccination data.

III. MANAGEMENT OF A MASS VACCINATION CAMPAIGNIn planning for this type of campaign, there will be a number of activities that need to be considered for simultaneous management. With any scale of operation, the operational considerations require careful and ongoing planning with a host of traditional and possibly new partners to accomplish the mission. Many of these activities have interrelated dependencies that require time sequenced completion. Using the objective-based management approach of the Incident Command System (ICS) in planning for and implementation of the campaign will provide a framework that is well suited for ensuring all activities are effectively addressed. Additionally, the expandable nature of ICS will allow for component parts to accomplish objectives for both disease surveillance and management, but also run the vaccination components simultaneously should the need arise to manage a disease response concurrently with a mass vaccination campaign. The structure example provided below, is designed to manage the vaccination campaign and can be scaled up to encompass additional activities for a possible larger H1N1 Influenza response.

Given the length of the campaign, the operational periods will probably be expanded beyond the traditional 12-hour periods for ICS. It is recommended that the operational period be defined as a three-day interval that may include the weekend depending on vaccination clinic design.



IV. VACCINE MANAGEMENTA. General InformationVaccine accountability is coordinated with the Bureau of Immunization, Central Pharmacy, and the county health departments (CHDs). Designation of overall coordination at the Central Office will be made once final guidance is received on vaccine distribution. CHDs will designate a Vaccine Coordinator and Assistant Vaccine Coordinator who will be responsible for all aspects of the vaccine management process in their CHD and for training of other staff who will maintain accountability and the cold-chain custody. This responsibility includes:

• Ensuring cold-chain maintenance of vaccine both at the CHD, any designated off-site storage facilities, and while in use in mobile or off-site clinics.

• Managing vaccine logistics to ensure vaccine is available at all vaccination clinic locations while minimizing the risk of wastage.

• Ordering vaccine from the Bureau of Immunization or other designated process as may be needed.

• Assisting in the transfer of vaccine from one location to another.


INCIDENTCOMMANDER

Planning Section Chief

Operations Section Chief

Logistics Section Chief

Public Information Officer

(May Be Part of JIC)

Resource Unit

Technical Specialist(Vaccine/Medical

Mgmt)

Vaccine Coordination Unit

Information Dissemination Unit

Data Entry Unit

External Partner Vaccination Unit

CHD Vaccination Unit

Medical Supply Unit

Vaccine Mgmt Unit

Finance Section Chief

Time Unit


• Re-allocating vaccine stocks as demand requires between counties.• Appropriately disposing of empty, wasted, reconstituted/expired, or reconstituted/non-

expired (if directed) vaccine vials as instructed.• Ensure security of the vaccine throughout the vaccine management process.• To assist with these responsibilities, Vaccine Coordinators and Assistant Vaccine

Coordinators must have working knowledge and access to Vaccine Management resources located on <insert website> and the Vaccines for Children website at http://www.doh.state.fl.us/disease_ctrl/immune/vfc/index.html. These resources include:DOH Technical Assistance Guidelines, Vaccine Management Section.

B. Flow of Influenza Vaccine to Vaccination Clinic LocationsThe diagram below outlines the flow for ordering vaccine and vaccination supplies to vaccination clinic locations.

This will be provided once federal guidance is received.

C. Ordering Influenza VaccineThe Bureau of Immunization, Central Pharmacy and the CDC will work together to ensure that vaccine is readily available for CHDs. To order vaccine the CHD should use the defined process for ordering. A properly completed form would indicate the total number of doses currently in inventory at the CHD and the doses requested.

The CHD Vaccination Coordinator must follow these steps: Inventory the doses on hand under CHD control and doses dispensed.

Determine the number of additional doses needed.

Complete order form in accordance with Bureau of Statewide Pharmaceutical Services or designated authority’s guidance.

Influenza Vaccine For purposes of tracking, the Vaccine manufacturer and lot number will be associated with the vaccination program

Ancillary Vaccination Clinic Supplies and EquipmentThe CHD will acquire ancillary supplies and equipment sufficient to administer the number of vaccinations to be given at each vaccination clinic in their geographical area. Central Office will develop and disseminate a process for ordering supplies provided with the vaccine as well as other supplies necessary to operate clinics. A standard list of supplies and equipment can be found in Appendix C. These ancillary supplies and equipment must be available prior to the operation of vaccination clinics.

D. Vaccine Shipping InformationCentral Pharmacy or other designated storage site to CHD Main Influenza Storage SiteCentral Pharmacy or designated site will prepare vaccines for shipment to the designated CHD. Vaccine will be shipped in Styrofoam containers suitable for maintaining the cold-chain environment. The containers will include ice packs to maintain proper temperature; however, the ice packs will not be placed against the vaccine. If needed, the CHD staff should retain shipping containers for use in transfers of vaccine.

Receiving Vaccine at CHD Main Site


http://www.doh.state.fl.us/disease_ctrl/immune/vfc/index.html

http://dohiws.doh.state.fl.us/divisions/php/ovf/vaccinate.htm


On receipt of vaccines, the Vaccination Coordinator, or his/her designee, must perform the following tasks:

Inspect the shipment for damage and confirm that the vaccine doses and lot numbers in the shipping boxes match the information printed on the shipping invoice.

Contact the Bureau of Immunization (850) 245-4342 or designated authority if discrepancies are found between the shipping invoice and the shipped boxes.

Remove vaccines immediately from shipping container and place in a monitored refrigerator. The temperature of this refrigerator must be 2-8 degrees Celsius (36-46 degrees Fahrenheit). The temperature of the refrigerator must be electronically monitored or manually

monitored with the temperature recorded early each morning and late each afternoon. If being monitored manually, a calibrated thermometer must be read and recorded twice daily by trained personnel.

Record receipt of vaccine following procedures in https://www.flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf

CHD Main Site to Vaccination Clinic Location Ensure that appropriate immunization service sites are established in Florida SHOTS for vaccine accountability. Immunization service sites for vaccine purposes should be permanent storage locations and transfers should take place between sites or locations pursuant to vaccine accountability practices.

Each CHD will determine the number of doses needed at a particular vaccination clinic based on the scheduled appointments. The following tasks must be completed by CHD staff for the shipment of vaccine to these vaccination clinic locations:

The vaccines must be placed in Styrofoam coolers with sufficient ice packs to maintain the cold-chain environment until it arrives at the destination.

Storage and handling instructions for the vaccine should be reviewed with all staff before they begin their shift.

Specific security needs for each vaccination clinic must be formally assessed and implemented consistent with local security plans.

Vaccine returned to the CHD site will be maintained in a Styrofoam cooler with cold packs suitable for maintaining a cold-chain environment.

Doses will be inventoried on arrival back to the CHD site and immediately placed in a monitored refrigerator unit until their disposition is determined.

Ensure that inventory is transferred back into main clinic site location in Florida SHOTS to ensure vaccine accountability.

The Vaccination Coordinator or his/her designee will retain all temperature logs relevant to Influenza vaccine storage.


https://www.flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf


E. Storage and Handling

Chain of Cold CustodyThe H1N1 Influenza vaccine must be managed and maintained in accordance with manufacturer’s instructions and CDC guidance.

The Vaccine Coordinator is responsible to ensure cold chain is maintained through proper handling and storage. Local transport and day use require the use of Styrofoam coolers and cold packs. Temperatures in day use containers should be monitored and ice packs replaced if needed. During breaks or lunch the vaccine should be moved to a temporary secure refrigerator.

During day use, medical staff should keep the vaccine in the container/cooler. However, vaccine may remain out of the cooler for the length of the vaccination clinic. It is anticipated that the typical clinic will last from 2-4 hours per session during which vaccines would be continuously administered and can be maintained at ambient temperature. Other than the duration of the vaccination clinic, the vaccine should not be taken out of the cooler and allowed to sit outside for any extended length of time. The vaccine should be returned to the refrigerator when not in use, such as during breaks or lunch.

VaccineRecommendations for the handling and storage of Influenza vaccine can be found in the manufacturers package insert.

The Bureau of Immunization will advise the CHD Vaccine Coordinator of any new vaccine issues.

F. Vaccine SecurityCHDs must ensure appropriate security:

Vaccine storage units will be designated as a secured area consistent with departmental policies and procedures. The area will be secured and access will be limited to only those persons authorized for access.

Backup power sources (generators) are recommended for all units where vaccine is stored overnight.

Should backup power sources not be available, the CHD Vaccine Coordinator is responsible for ensuring the CHD has documented procedures for ensuring a cold-chain environment, including the identification of suitable temporary cold storage units which meet the secured area requirements outlined in the departmental policies and procedures.

Vaccine transportation in the county should be handled in accordance with established security procedures developed by the CHD.

Vaccine must not be left unattended during clinic sessions.

G. Disposal of Empty, Wasted or Expired VialsEmpty, wasted or expired vials or vials containing wasted or unserviceable vaccine should be placed in Sharps container for disposal. Please refer to the Florida SHOTS user guide at



https://www.flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf for guidance in accounting for these doses.

H. Returning/Reallocating Vaccine to Central Pharmacy or CHDsIf a decision is made to return unopened vials of vaccine to the Central Pharmacy or other designated site, the CHD will implement the following procedures. This section is subject to change based on final federal guidance.

The Vaccine Coordinator will complete a Vaccine Return Form.

Vials of unopened vaccine returned to DOH Central Pharmacy or other designated site, or shipped to another CHD will be shipped in a suitable Styrofoam cooler with cold packs sufficient for maintaining a cold-chain environment.

Transportation of vaccine from the CHD to the Central Pharmacy or other designated site will be coordinated through the Bureau of Immunization and the Central Pharmacy and communicated to the Vaccination Coordinator.

The Vaccination Coordinator may acquire additional packaging material (i.e., coolers, cold packs, etc.) to ensure that the unopened vials are returned in the appropriate environment from the DOH Central Pharmacy.

Upon receipt of returned vaccines, designated personnel will immediately inventory vaccine received, examine and verify accompanying paperwork, and place the returned vaccine in an electronically monitored refrigeration unit.

Information regarding the receipt of vaccine (i.e., CHD address, quantity, lot number, and expiration date) will be checked by Central Pharmacy and the original Vaccine Return Form will be sent to the Bureau of Immunization.

Additional InformationHandling Influenza Biomedical Waste ItemsMaterials which may be contaminated and/or present a threat of infection to humans should be disposed as biomedical waste and placed in a sharps container.

Any questions regarding the handling and treatment of biomedical waste items associated with vaccination and vaccination materials should be referred to the Division of Environmental Health, BioMedical Waste Program. Their website is http://www.doh.state.fl.us/environment/community/biomedical/index.html.


http://www.doh.state.fl.us/environment/community/biomedical/index.html


V. VACCINATION CLINIC OPERATIONS

A. General InformationThe CHD is responsible to assure that all appropriate resources are available at each vaccination clinic location. The CHD should have a vaccination emergency action plan should emergency medical services be needed at a clinic.

If the clinics are restricting vaccination to certain groups, site security should be coordinated with local law enforcement. At a minimum, law enforcement will be required for traffic management.

B. RecruitmentIn order for the H1N1 Influenza Mass Vaccination Campaign to be a success, everyone involved in the process, from recruitment through post-vaccination monitoring, must be diligent in assuring that they have current information, are extremely attentive to detail and follow-up, and maintain close communication with other team members and partners. CHD staff must keep in mind the nature of the initiative and must expect that guidance may be updated as new information and data emerge during implementation. Information is expected to be updated frequently during the planning and implementation of the vaccination campaign.

Stage I-III priority groups will be invited to receive an influenza vaccination based on vaccine availability. Recruitment is the process of inviting volunteers to participate, informing them of the benefits and risks of the Influenza vaccination and assisting them in making an informed choice. The choice to receive an Influenza vaccination is voluntary. The CHD may inform potential vaccinees directly or through partnerships with other agencies and organizations.

The CHD Vaccination Coordinator will assure that participating partner agencies and CHD vaccination clinic managers have required vaccine information materials so vaccinees are able to make an informed choice. The potential vaccinee will be issued the following appropriate Influenza vaccine information:

Influenza Vaccine Information Statement (VIS)

Vaccine Consent Form

If the CHD will be providing vaccinations for priority group agencies, it is recommended that those agencies provide a list of personnel to be vaccinated to ensure appropriate personnel are vaccinated.

C. Vaccination SchedulingVaccination clinic locations and schedules must be flexible enough to accommodate employer requests for staggering staff vaccinations over time.

The CHD Vaccination Coordinator will facilitate training and insure quality control for hospitals, other healthcare facilities, private providers, and other designated agencies that will conduct Influenza immunization clinics at their location.

Each scheduled clinic shall have a designated clinic manager to coordinate activities and serve as the point of contact for the CHD Vaccination Coordinator.

The CHD Vaccination Coordinator shall maintain a consolidated list of clinics scheduled within the county, the list shall include the clinic manager, clinic location, clinic times, and target audience.


http://www.bt.cdc.gov/agent/smallpox/vaccination/pdf/smallpox-vis.pdf


Reporting and Data Management Notes:All participants in the vaccination campaign will utilize the Department of Health Florida SHOTS, the statewide immunization registry, to document the vaccination process including registering new patients, documenting doses administered, vaccine management for county health departments and recording adverse events.

For detailed information on how to enter Influenza data for individuals with contraindications into Florida SHOTS, see the user guide at https://www.flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf.

D. RegistrationThe registration clerk will:

Verify potential vaccinee against the list/roster of pre-screened individuals.

Encourage potential vaccinee to read the Vaccine Information Statement.

Advise potential vaccinee that there will be an opportunity to discuss any questions or concerns they may have with a medical screener.

Provide an overview of the vaccination process.

Advise the potential vaccinee that she/he may withdraw for any reason at any time prior to the point of vaccination.

Direct the potential vaccinee to the waiting area until called by the medical screener (and project possible wait time).

Reporting and Data Management Notes:The registration clerk will perform a search in Florida SHOTS to find the patient’s demographics and immunization history. If the patient is found in Florida SHOTS, the clerk will verify and update the patient’s demographic information. If the patient is not found in Florida SHOTS, the clerk will register the patient in the system and document any required additional information such as relevant tier group. A special guide will be available at <insert link> for specific instructions on documenting tier group information.

For more information on patient search and registration in Florida SHOTS see the user guide at https://flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf.

E. Medical ScreeningThe medical screening is critical to minimize vaccine risk for vaccinees. Medical screeners must be medically-trained personnel such as physicians, registered nurses, physician assistants, paramedics, licensed practical nurses (see note below) and nurse practitioners.

Note: Direct supervision by a registered nurse or MD should be provided if licensed practical nurses are assigned medical screening of Influenza vaccinees. It is recommended that signed documentation of the training be available for verification.

In a large vaccination clinic, an initial question session may be provided by personnel who are versed in interview techniques (disease investigators, for example). Persons may be referred to medical screeners based on their answers to the questionnaire.

Medical Screeners should rehearse the medical screening session to estimate the time that it will take to conduct the screening. The medical screeners will complete the following activities:


https://www.flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf


Ask if the vaccinee has any questions related to the VIS.

For individuals returning for second vaccination dose, review medical history since first dose including any problems with first dose.

Ensure accuracy of tier group assignment, documentation and entry into Florida SHOTS.

Document and assure that all potential vaccinee questions are answered.

Review contraindications to vaccination and record in Florida SHOTS.

Review common reactions and possible serious adverse events to the vaccine.

Explain common, typical, or mild reactions.

Answer questions/concerns regarding Influenza.

Obtain consent form.

Refer potential vaccinee to the vaccination station (VS).

It is paramount that medical screeners take the utmost care to ensure that potential vaccinees have been screened and understand risks and benefits of vaccination.

Reporting and Data Management Notes:For detailed information on how to enter Influenza data for individuals with contraindications into the immunization module, see the Influenza Data Entry Instruction Manual for Florida SHOTS.If the individual has not received the vaccine due to a contraindication, then this information should be entered into the Florida SHOTS contraindications screen.

F. Vaccination StationVaccine will be administered according to the recommendations of the Centers for Disease Control and Prevention (CDC) and Advisory Committee on Immunization Practices (ACIP) recommendations.

Medically-trained personnel who are authorized to administer vaccinations under state law can administer Influenza vaccine

Training for proper vaccine management/accountability must be accomplished if Influenza vaccination administration/clinics are conducted by approved agencies other than the CHDs.

Reporting and Data Management Notes:Please refer to the user guide at https://www.flshots.com/flshots/forms/FLSHOTSuserManualTrainingGuide.pdf for information on entering influenza data into Florida SHOTS.

The CHD is responsible for data collection, entry and record maintenance for this vaccination program even if the vaccine is administered by trained staff outside the CHD. The CHD will ensure that no later than close of business the next day and preferably the day of vaccination, all appropriate vaccination information will be entered into Florida SHOTS. All client forms that contain confidential medical information should be managed as confidential data, following applicable departmental policy and protocol for ensuring data confidentiality.



Once the data is entered into Florida SHOTS, the vaccine doses will be deducted from the existing influenza vaccine inventory. In addition, the vaccine utilization report will reflect updated doses administered.

See Section V- Adverse Event Management and Reporting for adverse event reporting.

Aggregate statewide vaccination data will be reported from Florida SHOTS to the CDC's Countermeasure Response Administration (CRA) System weekly beginning on October 15th. Weekly reporting will be required by Noon Monday of each week following the MMWR reporting schedule.

G. Exit ReviewThe Exit Review by a medical health care professional (CHD staff) at the exit station will include the following activities:

Collection of a signed consent form is to be determined.

Review side effects with vaccinee using the VIS Supplement A; Reactions After Vaccination information sheet.

Provide vaccinee an emergency 24/7 contact number.

Answer remaining questions or concerns regarding Influenza vaccination.

Complete consent to release medical information to the employer if indicated.

Schedule appointment or remind vaccinee of the due date for the subsequent vaccination if first visit.

The CHD will maintain the completed consent form in accordance with the current Department of Health Retention Schedule. The retention schedules are available at: http://dlis.dos.state.fl.us/barm/handbooks/basics.pdf .

Data from the completed vaccination record is entered into Florida SHOTS preferably on the day of vaccination, but no later than by close of business the day following vaccination administration.

The CHD coordinator or point of contact (POC) will be responsible for providing to the POC for the priority group agencies on a weekly basis a list of their personnel who have been vaccinated and return date for second dose vaccination during the initial vaccination phase.

Reporting and Data Management Notes:Data from the completed vaccination record is entered into Florida SHOTS preferably on the day of vaccination, but no later than by close of business the day following vaccination administration regardless of where the vaccination was administered. For vaccinations administered by approved trained staff, who are not CHD employees, the system administrator may add the temporary staff as personnel in Florida SHOTS under the CHD organization account so that the provider person ID displays for vaccination entry. The account should be given a termination date that ends with the campaign. This practice is acceptable under the restrictions of a public health emergency such as the H1N1 vaccination campaign. See Section V- Adverse Event Management and Reporting for adverse event reporting.

VI. ADVERSE EVENT MANAGEMENT AND REPORTING


http://dlis.dos.state.fl.us/barm/handbooks/basics.pdf


A. Adverse Event Medical Management The Florida Department of Health will support the medical and epidemiologic management of vaccinees presenting with adverse events by: (1) providing vaccinee and provider appropriate education and information, (2) facilitating triage and referral to healthcare providers for severe adverse events as requested, (3) identifying regional hospital-based physicians who are willing to see vaccinees with clinically-significant adverse events.

Each county health department will follow existing protocols for seasonal Influenza vaccine adverse events.

Vaccinees experiencing adverse events are likely to present to their primary care physician, or an emergency room. Each county health department must have a process in place to support medical management regardless of where or how a vaccinee presents with adverse events.

The medical management of adverse events associated with receiving the Influenza vaccine will be accomplished through the established healthcare system.

County Health Department Responsibilities CHDs will establish and disseminate a 24/7-phone number to each vaccinee for

consultation on adverse events. This phone number will be provided at the time of vaccination, as part of the exit review.

The CHD will establish processes to triage and refer vaccinees to healthcare providers upon request.

Each CHD will facilitate and monitor VAERS reporting for adverse events.

Department of Health Central Office Responsibilities The Division of Disease Control will identify the State VAERS Coordinator for

reporting of adverse events. See the Adverse Events Reporting section of this document.

The Division of Disease Control will conduct ongoing epidemiologic analysis of adverse events in Florida.

CDC Responsibilities Provide 24/7-coverage for clinical guidance.

Provide 24/7-coverage for State Health Department technical assistance.

Monitor clinically-significant adverse events at the national level.

Monitor reported adverse events for the occurrence of unexpected adverse events.

Provide clinical consultation line for providers for information about adverse events and who should be notified should adverse events occur.

Conduct epidemiologic studies to identify risk factors for adverse events following Influenza vaccine.

Conduct epidemiologic studies to evaluate causality of unexpected adverse events.

B. Adverse Event Reporting

Surveillance for Adverse EventsEach county health department will conduct surveillance for potential serious adverse events. Every vaccinee will be provided with a 24/7 number to call if they are experiencing an adverse event.



Reporting of all Adverse EventsThe VAERS reporting process reflects the VAERS reporting process that is done for all vaccines. Clinic staff at the CHD level is responsible for initiating the VAERS report when an adverse event is suspected or occurs. Because of the need to rapidly monitor the occurrence of Influenza adverse events and to follow up on serious reports, CHD health department staff will send reports via fax to the State VAERS Coordinator of the Bureau of Immunization, fax number 850-922-4195.

Note: Not all reactions that occur during the vaccination sequence are unexpected and/or characterized as adverse events. Events that meet the case definition for Influenza adverse events, anaphylaxis, serious illnesses and/or hospitalizations following Influenza vaccination should be reported. Additional guidance for determining unexpected reactions that are adverse events will be provided as it becomes available.

Submit reports of adverse events to the State Vaccine Adverse Event Reporting Coordinator by faxing the VAERS form to 850 922-4195 as soon as possible.

The VAERS Form, assistance in completing the form, or answers to other questions about VAERS are available via a 24-hour toll-free telephone number: 1-800-822-7967. The reporting form can be downloaded from the VAERS web page at www.vaers.hhs.gov.

Immediately after faxing the VAERS form to the State VAERS Coordinator, fax the report to the National VAERS Program at 1-877-721-0366.

VAERS Reports may also be submitted electronically to VAERS, but only after printing out and faxing a copy to the Bureau of Immunization instructions for electronic submission in addition to the VAERS Web Submission link can be accessed at the following Internet site: www.vaers.hhs.gov.

Attach pertinent information from the vaccinee’s medical record for serious adverse events.

Submission of a VAERS report

o Enter data regarding adverse events into Florida SHOTS as soon as possible.

o Incomplete reports should be submitted with as much information as soon as possible to ensure DOH and National VAERS staffs have all available information on potential adverse events.

o Timely Reporting: The CHDs will send all reports to the Bureau of Immunization and the National VAERS office as they occur. Do not send batches of reports. Do not wait for complete documentation before sending to VAERS, especially if the report appears serious. VAERS data is reviewed on a daily basis so that analysis and follow-up of serious reports can be conducted. Timely reporting is essential for timely follow-up investigation, especially if clinical specimens may need to be obtained.

o VAERS ID: The National VAERS office will send a confirmation notice to the reporter for all reports received, whether mailed or faxed. A unique VAERS ID number will be provided with the confirmation notice. Any follow up correspondence about a report must include the VAERS ID number. Reports are entered into the VAERS database under a unique ID number. It is also helpful to



have the patient’s name and date of birth, if available, to help identify the specific report.

o Missing, corrected, or supplemental information: Information such as medical records or autopsy reports may be submitted to National VAERS by phone, mail or fax. All copies must also be submitted to the Florida Department of Health, Bureau of Immunization at the time you submit them to the National VAERS program.

Medical Management Flow of Adverse Events

Pending CDC Guidance



VII SAFETY The safety and welfare of all participants in the H1N1 Influenza Mass Vaccination Campaign is the prime consideration at every stage. Safety and welfare issues are handled in two ways: first, every section of this Technical Assistance Guidelines addresses safety and welfare as clinical and ethical imperatives. Secondly, the plan takes an “all risks” approach to implementation, by using the HACCP (Hazard Analysis and Critical Control Point) methodology to isolate and manage any aspects of the project that are vulnerable to error or failure.

A. Clinical and Ethical SafeguardsMonitoring and safety procedures for potential adverse events are assigned for each county health department and an adverse event reporting system is in place. Each criterion functions as a “hurdle” to a potential hazard in the vaccination and post-vaccination process:

Vaccination is voluntary for all designated priority group members.

Informed consent is a precondition for participation. See key term “Provision of Risk/Benefit Information” for information on how to ensure that risk/benefit information is provided and key term “Informed Consent” for definition as well as key term “Vaccine Information Statement” to ensure that this precondition is fully met.

Eligibility criteria are developed based on impact of the disease on population groups.

Priority in selection of participants will be based on federal guidance.

At the vaccination clinic itself, pre-vaccination screening for contraindications should be conducted, the provision of risk/benefit information should be provided, and the patient’s informed consent obtained. This evaluation and pre-requisites for vaccination should be conducted by trained personnel.

Claim or suit arising out of the administration of the vaccine must be filed solely against the Federal Government.

Monitoring and safety procedures for dealing with potential adverse events are assigned for each county health department and an adverse event reporting and referral system is in place, right through to CDC.

VIII. COMMUNICATIONSA. Communications Flow, Support and Management

1. Partnership: Establishing County-Level Influenza “Points of Contact”The county health departments are responsible for communication within their jurisdiction to healthcare providers and the public. In order to facilitate effective information flow, each CHD shall appoint an Influenza Communications Point of Contact. This contact shall be responsible to support the designated Public Information Officer and/or spokespersons. The contact will serve as a liaison to the Regional Risk & Crisis Communications Consultants and the Office of Communications.

2. Issue ResolutionIssues raised by CHDs will be reviewed through the Office of Communications when necessary and a response given as soon as possible, or at the latest within 48 hours. Issues should be



sent by email to Office of Communications, marked for the attention of the Communications Coordinator, Influenza.

The Office of Communications will provide support to the CHD through maintaining an H1N1 Website, disseminating information to the CHD Communications Points of Contacts, conducting routine briefings, and supporting the Regional Risk and Crisis Communications Consultants to problem-solve issues as indicated.

3. Regular BriefingsRegular briefings between the H1N1 Influenza Mass Vaccination Implementation Team, the Office of Communications and CHDs will underpin the partnership. Regularly scheduled conference calls with county health department directors/adminstrators, CHD Public Information Officers and partner PIOs will be announced via email. CHDs will be copied on all significant communications activities to insure a smooth flow of information between DOH and CHD PIOs and senior personnel.

B. Communications TracksThere are two main audiences in this communications process – designated priority group members and general public.

1. Vaccinee Audience: the Vaccinees and DOH as Partners. The Office of Communications will continue to update and improve a repository of assets and knowledge on H1N1 Influenza, digested into briefings “kits” and updates. Taken together, these elements constitute a significant resource for all those engaged in informing and supporting the participants. The core messages, however, remain the same:

That not responding to the threat of a novel Influenza is much more risky than responding; Influenza kills 36,000 Americans annually of those it infects.

That we have done this before and we can do it again. Vaccination programs are an essential component of public health practice.

A more detailed listing of the contents of the H1N1 Influenza communications assets will be provided as they become available.

Directly, participants are informed individually and through professional affiliation or employment channels. Special needs are met with targeted information, largely derived from CDC source materials. The Office of Communications will work in conjunction with the H1N1 Influenza Mass Vaccination Campaign Team to handle this task in direct collaboration with the CHD PIOs and the partners.



IX. REPORTING AND DATA MANAGEMENTVaccine inventory, doses administered, contraindications, adverse events and tier group assignment will be entered into Florida SHOTS. Doses administered will be entered preferably the day of vaccination but no later than by close of business the day following vaccine administration. There are three possible scenarios for reporting:

CHDs enter data directly into Florida SHOTS for CHD-hosted clinics. Private providers receive access to Florida SHOTS and enter data directly for any

vaccinations provided in their facilities. Private providers provide vaccination data on all vaccinations provided in their facilities

to the local CHD for entry into Florida SHOTS in accordance with required reporting timeframes.

Statewide aggregate data will be uploaded from Florida SHOTS to the Centers for Disease Control and Prevention Countermeasure Response Administration System beginning on October 15, and weekly thereafter by the following Monday of each week. This reporting periodicity is required in order to meet MMWR publication deadlines.

A. Immunization RegistryFor detailed information on how to enter Influenza data into the immunization module, see the Influenza Data Entry Instruction Manual for Florida SHOTS.

Note: The source document for data entry will be developed.

B. Reports Reports to be determined.



X. FUNDING AND STAFF RESOURCESA. Expenditures of Pre-event and Post-event Vaccination

CHDs should continue to use the OCA established to track expenditures for the H1N1 Influenza Response. As guidance is received on supplemental funding, that information will be provided to CHDs.

Salary costs for all activities related to Influenza vaccination should be coded according to existing departmental policies and procedures.

CHDs and central office will code all non-salary expenditures for possible future reimbursement to the new OCA.

B. Department of Health, Human Resource ManagementStaff Roles and Responsibilities by PositionsThe following staff roles and responsibilities are provided as a framework for consistent implementation of the program across the state. County Health Department Influenza Coordinators may choose to assign or group responsibilities differently to accommodate local staffing availability and expertise.

1. County Health Department H1N1 Influenza Vaccination Coordinator - a public health professional with overall responsibility for implementation of the program in the designated county. The coordinator will be the point of contact for H1N1 Mass Vaccination Campaign Team.

The County Health Department Influenza Coordinator is responsible for managing the coordination with partner agencies for ensuring vaccination of priority groups.

Ensure all required reports are submitted appropriately.

Coordinate the location and times of vaccination clinics.

Assure that all vaccine dispensing team supplies are available 48 hours prior to a scheduled vaccination clinic.

Acquire ancillary supplies and have available equipment sufficient to administer the number of vaccinations to be given at each vaccination clinic in their geographical area.

Receive personnel lists from partner agencies for any individuals to be vaccinated by the CHD.

Ensure that consistent educational information is disseminated to appropriate CHD and partner agency personnel.

Ensure that by close of business the day after vaccine administration (and preferably the day of), all appropriate vaccination information from the previous day's activities will be entered into Florida SHOTS.

Receive report and take assessments of adverse reactions.

Ensure that all vaccinating partners have Florida SHOTS accounts established and follow procedures for updating doses administered in the system.

2. Vaccine Manager/Assistant Vaccine Manager - a public health professional who is responsible for all aspects of vaccine management throughout the duration of the campaign.



The Vaccine Manager reports to the County Health Department H1N1 Influenza Vaccination Coordinator.

Receive information from BOI or designated authority on number of doses and manufacturer’s lot number to transfer.

Open vaccine package, keeping packaging for future reshipment.

Maintain appropriate cold chain of custody.

Confirm vaccine doses and lot numbers matches information received from BOI or designated authority.

Record receipt of vaccine in Florida SHOTS for inventory management. Maintains thorough knowledge of Florida SHOTS inventory management for vaccine accountability and reconciles vaccine inventory on a weekly basis.

Contact designated authority if there are discrepancies with shipment.

Ensure security of the vaccine.

Return vials as may be directed to designated authority.

Arrange for transfer of vaccine to other CHDs based upon identified needs.

3. Medical Monitor – A public health professional trained in the principles of epidemiology to oversee the monitoring of adverse events and the collection and reporting of data for this program. Medical Monitor is responsible to the County Health Department H1N1 Influenza Vaccination Coordinator.

Monitor vaccination rates by priority group and demographics throughout the vaccination campaign.

Facility point of contact will coordinate with the Medical Monitor for reporting adverse reactions.

Receive daily reports compiled by each facility.

Assure reporting of adverse events to the State VAERS Coordinator and through the VAERS System.

Responsible for reporting to the Division of Disease Control if adverse events are suspected.

4. Medical Assessment Screeners - Medical Screeners should be medically trained personnel such as physicians, registered nurses, physician assistants, LPNs, paramedics, and nurse practitioners.

Answer questions/concerns regarding Influenza.

Screen for signs and symptoms of influenza-like illness (ILI).

Review medical history of vaccinee.

Document response/answers of potential vaccine.

Review contraindications to vaccination.

Collection of signed consent form to be determined.



5. Vaccinators/Assistants – Medically trained personnel such as physicians, registered nurses, physician assistants, nurse practitioners, LPN (see Note below), and paramedics authorized to administer the vaccine, according to the CDC and ACIP recommendations.

Document vaccination on appropriate form.

Fill out data collection form (to be developed). Collection of a signed consent form to be determined.

Note: Direct supervision by a registered nurse or MD should be provided if licensed practical nurses are assigned medical screening of Influenza vaccinees. It is recommended that signed documentation of the training be available for verification.

6. Clerical (Registration Clerk) – Collect retained records and enter registration/vaccination information into database.

Verify identity of the potential vaccinee.

Ensure the appropriate data collection of tier group assignment and accurate entry into Florida SHOTS.

Perform patient search of Florida SHOTS and update demographics or register patient if not found.

Retrieve the vaccinee’s Influenza vaccination record.

Provide vaccination information and forms as appropriate.

Advise potential vaccinee they will have an opportunity to discuss any questions/concerns with a medical screener.

Encourage review of the VIS and medical check list, if not done prior to arrival at the clinic.

Direct vaccinee to the medical assessment station or waiting area as indicated.

May also update vaccination data in Florida SHOTS as time allows.

7. Security Staff- Security staff functions include: (1) maintaining orderly clinic operations; (2) protecting patients; (3) protecting employees; (4) protecting facility property, including medical supplies and vaccine; and (5) enforcing the direction of ILI symptomatic clients to an alternative section of the clinic. To fulfill these functions, security staff must have the capacity to:

Manage the facilities’ security resources.

Monitor the physical facility.

Recognize potential for mob behavior.

Control access to the facility and areas within it.

Provide a means to identify authorized employees.

Update an authorized personnel list on an ongoing basis.

Coordinate with other security agencies.

Direct person in need of care to alternative facilities.

Remove individuals who pose a risk to the facility and its operation.



Follow the emergency response plan of the state, county and/or facility.

Communicate with clinic staff, the command center, and external security personnel.

Perform a secure lock down of the facility quickly.

Obtain additional security resources in a predefined “emergency” situation.

Respond with appropriate force if required.

Provide information to persons massed outside the facility.

C. Healthcare Partner Agencies Roles and Responsibility for Healthcare H1N1 Influenza Vaccination Teams

Step 1: Educate Form a planning team consisting of infection control, epidemiology and employee

health staff.

Designate a hospital point of contact to coordinate with the County Health Department H1N1 Influenza Vaccination Coordinator.

Pre-screen potential vaccinees to exclude those with contraindications to vaccination.

Education and pre-screening of identified candidates on benefits, risks, contraindications, and procedures for Influenza vaccination.

Step 2: Vaccinate Submit a list of approved, pre-screened potential vaccinees to the County Health

Department H1N1 Influenza Vaccination Coordinator if CHD will be conducting vaccination clinics.

The hospital point of contact will coordinate the location of vaccination clinic for their personnel with the County Health Department H1N1 Influenza Vaccination Coordinator.

Coordinate with County Health Department access to Florida SHOTS for data entry for all personnel vaccinated in-house as well as ordering of vaccine and supplies.

For in-hospital clinics provide clinic space that meets standards set forth to effectively, efficiently and safely administer the vaccine.

Schedule potential vaccinees for vaccination at designated public health vaccination clinics or in-house clinics.

Ensure appropriate follow-up for receipt of second dose of vaccine.

Step 3: Monitor Triage adverse reactions.

Report adverse reactions to the County Health Department H1N1 Influenza Vaccination Coordinator or his/her designee.



XI. KEY TERMS

Adverse event Untoward effect from vaccination, ranging from mild to severe (low-grade fever and malaise to death).

Consent Permission given by the patient or legal representative allowing another person to perform a therapy, treatment or procedure.

Contact A person who has recently been exposed to a contagious disease (e.g. Influenza).

Contagious (Communicable)

Carrying an infectious disease that a person can pass it on to others. A disease that is easily transmitted from host to host by casual contact or respiratory droplets.

Differential Diagnosis Identification of a disease by comparison of the symptoms of two or more similar diseases.

Eligible People who have been pre-screened and cleared of contraindications to the Influenza vaccination.

Epidemiology The study of the distribution and determinants of health problems in specific populations and the application of their study to control these health problems.

Exposure The condition of being exposed (been in contact with an infected person or agent) to a communicable disease (e.g. Influenza).

Florida SHOTS The statewide immunization registry which is the official data collection system for vaccine accountability and doses administered.

Immunize To make immune, to administer immunization (e.g. to vaccinate against Influenza). Process of inducing or providing immunity artificially by administering an immunobiologic.

Immunocompromised Having the immune system impaired or weakened, as by drugs or illness, e.g. AIDS/HIV, drugs for cancer, or transplant patients. Having an immune system incapable of reacting to pathogens or tissue damage.

Immunology The study of the components of the immune system and their function.

Incubation Interval between exposure to infection (Influenza) and the appearance of the first symptoms (tangible and visible reactions, like fever). People are not contagious during the incubation time.

Incubation period For Influenza, the incubation period is an average of 1 to 3 days, as long as 7 days after people have been exposed to Influenza.

Infection The state produced by the establishing of an infectious agent in or on a suitable host.



Informed consent Informed consent is the acknowledgement by the patient, parent or legal representative that they wish to receive the vaccination. Informed consent follows the provision of risk/benefit information accomplished by giving the patient, parent or legal representative the appropriate VIS which contains information about the disease being prevented, vaccine, risk and benefits of vaccination as well as potential adverse events. See “Provision of Risk/Benefit Information” for further definition.

Isolation (isolation- related activity)

Limitation of movement and contact from other people who have contracted a communicable disease (Influenza) until they are no longer contagious.

Mass vaccination Vaccination of large groups of people.

Pre-screening Process of screening people for contraindications to the Influenza vaccination and reviewing risk/benefit education with them to determine if the participant is “eligible” for vaccination.

Provision of Risk/Benefit Information

The provision of risk/benefit prior to vaccination consists of providing the patient, parent or legal representative the appropriate VIS form to read prior to vaccination. The fact that this information was provided must be documented by noting the date of the VIS and the individual providing the form. A specific VIS will be available for H1N1 vaccine.

Region (Geographic) A geographic area composed of two or more counties.

Risk Risk vs. benefit. Possibility of loss, injury, disease or death from either Influenza or Influenza vaccination.

Screening Process of history-taking/evaluating for the safety and appropriateness of vaccinating individuals for a treatment or procedure (e.g. Influenza vaccine)

Serious adverse event (SAE)

A severe negative side effect as a result of administering a treatment (i.e. from vaccination) including loss of limb, injury, disease or death.

Surveillance The collection, analysis, monitoring and dissemination of data (i.e. close and continuous observation and counting of cases of diseases).

Vaccine Information Statement (VIS)

VIS forms are CDC-developed documents that explain the disease being prevented, information about the vaccine, the risks and benefits of the vaccine, contraindications to the vaccine and potential adverse events and how to report these to the Vaccine Adverse Event Reporting System. The provision of VIS and documentation that this was provided to the patient, parent or legal representative is required by the Vaccine Injury Compensation Act for any vaccine covered under the Act. Documentation of the provision of VIS includes recording the date of the VIS form and the individual providing the form. See the definition for “Provision of Risk/Benefit Information” for further information.

Vaccinate To immunize using a vaccine (e.g. with Influenza vaccine).



Vaccination site The location on the body where a vaccine is administered. The non-dominant arm should be used.

Virus The causative organism/agent of an infectious disease, e.g. Influenza.



APPENDIX A- PLANNING SCENARIOS

CDC Recommendations for State and Local Planning for a 2009 Novel H1N1 Influenza Program (7-9-09)

The purpose of this document is to describe planning scenarios for state and local governments to target high-priority populations for vaccination in order to reduce the health and societal impact of the novel H1N1 influenza virus.

Background

Data from U.S. and international sources suggests that it is appropriate to plan for a vaccination program to reduce the health and societal impacts of the novel H1N1 Influenza virus. In order to increase the probability of success of such a program, planning scenarios should be provided to state and local health authorities promptly. Planning scenarios can facilitate readiness to implement specific plans within states and large cities, improving the chances that vaccine will reach target populations when recommendations are made, and that distribution, delivery, and communication efforts regarding vaccination will overcome local challenges and maximize capacities.

Ongoing analysis through the summer of available data on the epidemiology and virologic characteristics of 2009-H1N1 virus and about vaccine efficacy will guide decisions about features of the program. These decisions will be made in collaboration with expert panels and with input from the public. For example, CDC’s Advisory Committee on Immunization Practices will provide specific vaccination recommendations, including specific target populations and priorities for circumstances of limited or phased vaccine supply. In addition, the National Vaccine Advisory Committee will provide guidance on implementation and evaluation of vaccine safety. A public engagement effort will also seek input from citizens from several regions around the country about these matters. While additional data are collected and reviewed, state and local public health authorities need to accelerate their outreach to health care providers, the private sector, occupational groups, and others to put in place mechanisms and to develop vaccination venues appropriate to reach groups most likely to be included in a vaccination program against pandemic H1N1 Influenza.

Rationale Used in Developing the Planning Scenarios

The particular configuration of the vaccination program in each state and local jurisdiction will be determined by the population groups for which vaccine is recommended, and vaccination planning needs to encompass the diverse venues where vaccine might be delivered. Identification of highly-affected populations to date can highlight venues that need to be ready to administer vaccine to the various populations that might be included in the program, and provide the rationale for the planning scenarios. Populations included in planning scenarios are based on the best current data to facilitate state and local planning.

Evidence to date suggests that population immunity to this virus is low, particularly among the young. In one small serologic study of samples collected during 2006-08, cross-reacting antibody were found among some older persons but not in any younger adults or children. Widespread susceptibility to this virus among young persons creates the potential for large numbers of cases with more hospitalizations and deaths among younger age groups than would be expected for a typical routine seasonal Influenza virus. Importantly, severe disease and death caused by novel H1N1 thus far have affected younger adults, children, and pregnant women, in addition to persons of all ages with certain underlying medical conditions more than the elderly. The virus has also caused numerous outbreaks in schools and summer camps.



Planning Assumptions

These planning scenarios are based on the following assumptions at the time vaccine becomes available and distribution begins:

a) severity of illness is unchanged from what has already been observed

b) risk groups affected by this virus do not change significantly

c) vaccine testing suggests safe and efficacious product

d) adequate supplies of vaccine can be produced

e) no major antigenic changes are evident that would signal the lack of likely efficacy of the vaccines being produced

Planning Scenarios

The following are best-case planning scenarios that would be recommended in a setting of limited initial vaccine availability.

Target population: Students and staff (all ages) associated with schools (K-12 grade) and children (age ≥6 months) and staff (all ages) in child care centers.

Primary venues: schools and child care centers.

Goals: Provide direct protection against illness among persons who have high attack rates of illness, reduce likelihood of outbreaks that may lead to disruptive school dismissals, reduce transmission from schools into homes and the community.

Adherence to these guidelines will require state and local authorities to carry out extensive planning to reach school-aged populations either through venues such as school-associated mass vaccination efforts, or, where private capacity is sufficient, through local pediatric providers. Local pediatric care providers may play a particularly prominent role in vaccinating preschool-aged children who have a medical home. These planning efforts will reinforce longer-term immunization targets of strengthening vaccination efforts in these populations, and building links between health and education. The disruptive outbreaks prevalent in schools and some universities in the spring of 2009 may provide impetus for these planning steps to move forward actively. They will also permit strengthening capacity for seasonal Influenza vaccination of school-aged children in future seasons.

Target population: Pregnant women, children 6 months – 4 years of age, new parents and household contacts of children <6 months of age.

Primary venues: Provider offices, community clinics.

Goal: Reduce complications of novel H1N1 Influenza, such as excess hospitalizations and deaths among those vulnerable for serious complications of Influenza, as evidenced by higher rates of hospitalization; protect the youngest (<6 months) who are not themselves able to be vaccinated through immunization of their household contacts.

Sustaining a focus on pregnant women and young children is appropriate given their high rates of complications and hospitalizations to date, and is consistent with tier 1 prioritization for these groups in pre-pandemic planning.

Target population: Non-elderly adults (age <65 years) with medical conditions that increase the risk of complications of Influenza.

Primary venues: Occupational settings, community clinics, pharmacies, providers’ offices. (Experience with seasonal Influenza vaccine suggests that persons with underlying illness age



50 to 64 years may be more likely to receive vaccine from their provider, while younger persons may be more likely to be vaccinated elsewhere).

Goal: Reduce risk of hospitalizations and deaths among persons with higher rates of these complications than the general population, and focus vaccine where its impact can be most beneficial for direct protection.

The planning requirement to offer vaccine to young adults with risk factors will permit state and local authorities to address a group that does not frequently seek health care and has relatively low rates of vaccination against seasonal Influenza. Links with occupational clinics, adult providers, or contingency plans for community venues or pharmacies are all options that might address this important at-risk group.

Target population: Health care workers and emergency services sector personnel (regardless of age).

Primary venue: Occupational settings, providers’ offices.

Goal: Reduce risk of illness, sustain health system functioning, and reduce absenteeism among front-line providers; reduce transmission from emergency services personnel and health care workers to patients; provide additional worker protection in settings of increased exposure; reinforce importance of influenza vaccination among all health care workers.

Note: Immunization of military (e.g., deployed forces) may be appropriate given the current circumstances; however, this memo focuses on vaccination of civilian populations under the authority of CDC and state and local health departments.

Vaccine Availability Considerations

If vaccine is widely available, CDC would recommend offering vaccine at multiple venues to anyone who wants to be vaccinated. Although the benefits of vaccine may be greatest in the persons in groups at increased risk, and interest in being vaccinated may be lower among the general population, offering vaccine to everyone can reduce the risk of Influenza for general population and may reduce transmission to unvaccinated persons. At the same time, if vaccine supply is limited, it will be important to consider a balance between international needs for vaccine in relation to the vaccination of low risk individuals in the United States.

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong

partnerships with local, national and international organizations.



APPENDIX B- PLANNING ASSESSMENT CHECKLISTThe following checklist is provided to help prioritize planning efforts and ensure that plans address the unique factors associated with the current H1N1 Influenza virus and a mass vaccination campaign of this magnitude. By assessing and quantifying where indicated, the items below, counties will be better able to determine resource needs, identify gaps, and develop contingencies. This checklist focuses on key factors and may not address all details of a mass vaccination plan.

Not Identified(Note date assessed)

Identified(Note date assessed)

Data Complete(Note date assessed

Vaccination1. Pregnant women

a. Estimate number of pregnant women in county

b. Determine number of OB providers, including family practice and clinics, who are willing to provide vaccinations for their patients and their families, and their staff.

c. Determine approximate amount of vaccine and supplies needed for each provider.

d. Determine if provider will enter into Florida SHOTS or CHD.

2. Children a. Estimate number of children in

age ranges 6mos-2y/o, 5-9y/o, 10-14y/o, 15-19y/o.

b. Determine number of pediatrician offices willing to provide vaccinations for their patients and their families, and staff, and ability to enter into Florida SHOTS.

c. Coordinate with CMS offices and develop plan for ensuring vaccination of their high-risk population.

d. Determine approximate amount of vaccine and supplies needed for each provider.






e. Coordinate with local Juvenile Justice Detention facilities and develop plan for vaccinating their populations and staff.

3. Childcare Centersa. Identify all childcare centers in

county for targeted information messaging.

b. Determine number of staff willing to receive vaccination

c. Determine which childcare centers may be utilized for vaccination clinics.

d. Develop vaccination clinic plan and resource requirements.

4. Schoolsa. Determine number of staff at

all schools K-12 public and private willing to receive vaccination.

b. Identify any schools that are exclusively for children with special needs and develop plan for ensuring vaccination as this is a high risk subpopulation of children.

c. Determine which schools may be utilized for vaccination clinics.

d. Develop school-based vaccination clinic plan and resource requirements.

5. Non-elderly (<65y/o) with underlying medical conditions

a. Identify all group homes for developmentally disabled and determine population ages.

b. Develop outreach plan for targeting this population in the community.






c. Identify community clinics, occupational clinics, private providers, and other venues where vaccinations could be provided. Develop vaccination plan with these providers.

d. Develop plan to provide vaccination clinics in the community to reach this population, if appropriate.

6. Emergency Medical Services Providers

a. Identify all EMS providers in county.

b. Determine number of staff per agency willing to be vaccinated.

c. Determine provider’s ability to provide vaccinations to own staff. Develop vaccination plan and ability to access Florida SHOTS.

d. Develop plan for providing vaccinations to any staff whose provider is unable to vaccinate.

7. Healthcare workersa. Identify:

i. Hospitals including rehab and specialty

ii. Skilled nursing facilitiesiii. Private/public medical

practices including federally-qualified health centers

b. Determine number of staff per agency willing to be vaccinated and agency’s ability to provide vaccinations.

c. Develop supply plans and determine ability to access Florida SHOTS for those agencies vaccinating own staff.






d. Develop vaccination plans for those agencies unable to vaccinate own staff.

8. CHD Staffa. Determine number of staff

willing to be vaccinated.b. Develop vaccination plan.

Training1. Develop training plan for providers

new to using Florida SHOTS.2. Develop plan for cross-training staff or

training new staff on Florida SHOTS data entry.

3. Identify any staff training needs related to mass vaccination clinic operations including forms, organization, vaccine administration (including adjuvant if applicable).

Logistics1. Develop plan for storage, distribution, and re-supply of vaccine and vaccination supplies to providers and partner agencies.2. Develop contingency plan for coordinating with central office to remove vaccine from county if hurricane threatens.3. Identify security needs for any mass vaccination clinic sites.



APPENDIX C- LARGE SCALE CLINIC SUPPLY LIST

General Supplies and Equipment

TablesChairsWater and cupsPaperPen, pencilsEnvelopesRubber bandsTapeStapler/staplesScissorsPost-it NotesClipboardsFile boxesTelephone/Cell phonesPaper towelKleenex tissueTable pads/clean paper Trash containers/bags ID badges for staffList of emergency phone numbers

Vaccine AdministrationSupplies

Cooler/refrigerator for vaccineNeedlesSyringes“Sharps” containersLatex glovesLatex-free glovesAntibacterial hand-washing solutionsAlcohol wipesRectangle band-aidsGauzeAdhesive tapeSpray bottle of bleach solution

Crowd ManagementSupplies

Signs for clinic stations and between stationsQueue partitions (to keep people in lines), roping

EmergencySupplies

Standing orders for emergenciesEpinephrine 1:1000 SQDiphenhydramine 50 mg IM3cc syringes with 1”, 25-guage needles1.5’ needlesTuberculin syringes with 5/8” needles (for epinephrine)Alcohol wipes/Sterile dry padsBandagesTongue depressorsAdult and pediatric pocket masks with one way valveAdult and pediatric airways tubesTourniquetGurneyStethoscopeFlashlight/batteriesBlood Pressure MonitorInstant Cold PacksCotsBlanketsPillows

Computer Equipment and Supplies

ComputersPrinters/Ink CartridgesPaperInternet access

The suggested supply list below is from the CDC’s Guidelines for Large Scale Pandemic Vaccination Clinics document and can be used as a guide for ensuring appropriate supplies are available at clinic sites.


Health & Medicine

Technical Assistance Guidelines.doc