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New York State Department of Health (NYSDOH) Novel H1N1 Influenza Mass Vaccination Campaign Plan

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       I.




      New York State Department of Health (NYSDOH)
    Novel H1N1 Influenza Mass Vaccination Campaign
                          Plan
                                  (September 14, 2009 at 1200)

                             All previous copies considered obsolete




“The information contained in this document is CONFIDENTIAL. No information from this
document shall be released when such release would jeopardize efforts to prepare for a public
health emergency, and thereby endanger the life or safety of the people of the state or locality”.
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I.         Table of Contents
II.        Introduction........................................................................................................................................ 3
      A.        Authorities........................................................................................................................................3
      B.        Plan Distribution & Cycle................................................................................................................3
      C.        Related Plans & Guidance Documents ............................................................................................4
III. Purpose............................................................................................................................................... 4
IV. Scope.................................................................................................................................................. 4
      A.  Overall..............................................................................................................................................4
      B.  Emergency Operations Objectives...................................................................................................4
        1. Response                                                                                                                                            4
        2. Recovery                                                                                                                                            5
      C. Specific Tasks ..................................................................................................................................5
        1. Central Office                                                                                                                                      5
        2. Regional Offices                                                                                                                                    5
        3. Local Health Departments                                                                                                                            5
        4. Healthcare Facilities                                                                                                                               6
V.         Planning Assumptions ....................................................................................................................... 6
      A.        Planning Assumptions .....................................................................................................................6
           1.     General:                                                                                                                                6
           2.     Logistics/Capacity/Distribution:                                                                                                        7
           3.     Allocation and Dispensing:                                                                                                              7
           4.     Public Information and Risk Communications                                                                                              8
VI. Concept of Operations ....................................................................................................................... 8
      A.     Activation Circumstances ................................................................................................................8
      B.     Operational Branches.......................................................................................................................8
           1. Incident Management System (IMS)                                                                                                          8
           2. Vaccination                                                                                                                               8
           3. Healthcare Infection Control                                                                                                              8
           4. Public Information & Risk Communications                                                                                                  9
           5. Legal Issues                                                                                                                            12
VII. Federal Agencies.............................................................................................................................. 13
Attachment 1: Record of Change............................................................................................................. 14
Attachment 2: NYSDOH Novel H1N1 Influenza Vaccine Workgroup Planning Requirements &
Assumptions.............................................................................................................................................. 15
Attachment 3: NYSDOH Incident Management System (IMS).............................................................. 23
Attachment 4: NYSDOH Concept of Operations for Mass Vaccination Campaign during the Novel
H1N1 Influenza Pandemic........................................................................................................................ 24
Attachment 5: Acronyms ......................................................................................................................... 57



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II.      Introduction
         New York State’s response to novel H1N1 influenza will be based on the pillars of enhanced
         disease surveillance, community mitigation measures, health care system surge capacity and
         vaccination, with an overarching focus on communication with our response partners and the
         public. Of these measures, immunization is of paramount importance; the Centers for Disease
         Control and Prevention (CDC) state that “influenza vaccination is the most effective method for
         preventing influenza and influenza-related complications.” According to the Advisory
         Committee on Immunization Practices (ACIP) of the CDC, the guiding principle behind
         recommendations for use of novel H1N1 influenza monovalent vaccine this fall is “to vaccinate
         as many persons a possible as quickly as possible.” New York State’s response is based on the
         ACIP recommendations, which are in turn based on current knowledge on the severity of the
         disease, the disease’s impact on communities and the safety and effectiveness of the novel H1N1
         influenza monovalent vaccine. The overall objective is to reduce illness and death due to the
         novel H1N1 influenza virus.

         This Novel H1N1 Influenza Mass Vaccination Campaign Plan has been developed by the New
         York State Department of Health (DOH) to guide the efforts of the DOH, other state agencies,
         Local Health Departments (LHDs), and the health care system in preparing and implementing a
         mass vaccination campaign. The plan also covers use of antiviral agents as part of the overall
         response to novel H1N1 influenza.

         A.        Authorities
                   1. Legal authorities regarding Novel Influenza and/or Pandemic Influenza are
                       provided in detail 2008 Pandemic Influenza Plan - New York State Department of
                       Health; Section 1: Command and Control, pages 1-3 & 1-41.
                   2. Guide to New York State Laws Governing Public Health Emergency Preparedness
                       and Response 2 .

         B.        Plan Distribution & Cycle
                    1. This plan will be distributed at the discretion of the NYSDOH Commissioner.
                    2. All planning partners will review and update this plan as needed, or:
                         a. In accordance with the review and update of the NYSDOH Pandemic
                             Influenza Plan;
                         b. As indicated by the After-Action Report (AAR) of an actual public health
                             emergency;
                         c. As indicated by the AAR of an exercise or drill;
                         d. Modifications will be made as required in accordance with Homeland Security
                             Exercise and Evaluation Program (HSEEP).
                         e. Contact information will be updated as needed.
                    3. The Commissioner or designee will brief members of the Disaster Preparedness
                        Commission (DPC) and State Agencies on revisions made to this plan.


1
 http://www.health.state.ny.us/diseases/communicable/influenza/pandemic/plan/docs/section_1.pdf
2
 http://www.health.state.ny.us/New York Statedoh/sars/preparedness_guidance/pdf/3c_guide_to_New York
State_laws_governing_bt_pr.pdf
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                4. A Record of Changes and/or amendments is included in Attachment 1.

       C.      Related Plans & Guidance Documents
                  • 2008 NYSDOH Pandemic Influenza Plan
                  • New York State Strategic National Stockpile (SNS) Plan
                  • New York State Department of Health Mass Dispensing Guide
                  • NYSDOH Incident Management System Annex
                  • NYSDOH Novel H1N1 Influenza Education Campaign Plan
                  • NYSDOH Novel H1N1 Community Mitigation Plan
                  • NYSDOH Novel H1N1 School Guidance

                   Guidance documents listed below will be issued separately:
                   • NYSDOH Novel H1N1 Surveillance Guidance
                   • Points of Dispensing Infection Control Recommendations
                   • NYSDOH Advisory – Fall Clinical Guidance
                   • Provider Planning Checklist,
                   • Fact Sheet on Tamiflu,
                   • NYSDOH Novel H1N1 Influenza Healthcare Surge and Triage Guidance
                   • NYSDOH Novel H1N1 Influenza Guidance for Community Health Centers
                      (CHC)
                   • NYSDOH Nursing Home Guidance for Pandemic Surge
                   • Hospital Pandemic Surge Trigger Guidance
                   • Outline of Surveys and Data elements to be Collected during H1N1
                      Pandemic/Moderate and H1N1 Pandemic/Severe
                   • Guidance on Public Facemask Use
                   • NYSDOH Guidance for Novel H1N1 School Surveillance

III.   Purpose
       A.      The purpose of this plan is to be prepared to respond to the consequences of the re-
               emergence of novel H1N1 influenza by providing the necessary guidance to implement a
               Mass Vaccination Campaign. It should be noted that this plan will be modified, possibly
               significantly during execution based on the situation at the time.

IV.    Scope
       A.      Overall

               The State’s Response will be based on the severity of the disease, the disease’s impact
               on our communities and the safety and effectiveness of the novel H1N1 influenza
               monovalent vaccine and antiviral medications with the overall objective of reducing
               illness and morbidity due to the novel H1N1 influenza virus.

       B.      Emergency Operations Objectives
                1. Response
                    a.  Implement fundamental policies, program strategies based on current
                        planning assumptions and conditions.

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                    b. Implement pre-determined staff roles and responsibilities as they relate to
                       the State’s response to novel H1N1 influenza.
                    c. Determine activities to be performed throughout each phase the novel H1N1
                       influenza pandemic.
                    d. NYSDOH will implement this plan in coordination with the Disaster
                       Preparedness Commission (DPC), the State Emergency Management Office
                       (SEMO) and the State’s Comprehensive Emergency Management Plan
                       (CEMP).
                    e. Response actions will be phased appropriately and incrementally to ensure
                       that the health and medical needs of the community are met throughout the
                       response to novel H1N1 influenza.
                    f. Additional guidance will be developed as required during the response.

                2.    Recovery
                      a.   NYSDOH will implement the recovery phase as soon as possible.
                      b.   NYSDOH will determine and provide guidance to communities on what
                           resources, including personnel, are required to be able to return to normal
                           daily operations.
                      c.   Additional guidance pertinent to the recovery of the State and local
                           communities will be provided as required.
                      d.   All recovery activities will be closely coordinated with the DPC and SEMO.

       C.      Specific Tasks
                1. Central Office
                     a.    Reduce loss of life, injury or illness resulting from novel H1N1 influenza by
                           preparing staff to carry out prompt and efficient response and recovery
                           activities.
                     b.    Perform assessments of NYSDOH’s capability to provide support to the
                           impacted health and medical infrastructure of the community.
                     c.    Identify those tasks or actions that will assist in the recognition and
                           implementation of mass vaccination activities.
                     d.    Define actions and activities that will be required to coordinate with
                           community (public), interagency and intergovernmental assistance.

                2.    Regional Offices
                      a.   Manage Surge Resources to LHDs to support the Mass Vaccination
                           Campaign.
                      b.   Provide technical assistance to counties and hospitals.
                      c.   Make presentations to identified regional organizations as requested.
                      d.   Conduct follow up with LHDs and Hospitals to ensure Mass Vaccination
                           Campaign success.
                      e.   Provide coordination and distribution of short dated antivirals to LHDs to
                           support non-insured and under insured as requested.

                3.    Local Health Departments
                      a.   Implement guidance provided by the State.
                      b.   Collaborate with local emergency management and planning partners,
                           including health care, to engage priority groups.

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                       c. Using State provided guidance implement local vaccination distribution and
                          dispensing strategies for novel H1N1 influenza.
                       d. Identify resource and surge needs for local response activities and
                          communicate needs with Regional NYSDOH offices.
                       e. Using guidance provided by the State, develop and/or improve the county
                          mass vaccination plan to:
                          i. Assure the maximum access to vaccines by persons in target groups.
                          ii. Coordinate the local health care system mass vaccination program.
                          iii. Identify gaps in vaccination access and coverage and develop plans to
                               fill those gaps.

                   4.    Healthcare Facilities
                         a.   Hospitals
                              i. Implement guidance provided by the State.
                              ii. Collaborate with local emergency management and planning partners.
                         b.   Other Healthcare Facilities
                              i. Implement guidance provided by the State.
                              ii. Collaborate with local emergency management and planning partners,
                                  including health care, to engage priority groups.

V.      Planning Assumptions
        A.        Planning Assumptions 3
                   1. General:
                        a.  Novel H1N1 influenza will recur in epidemic form this Fall/Winter and
                            clinical disease severity at an individual patient level will remain the same.
                        b.  Novel H1N1 influenza monovalent vaccine will be administered under a
                            declaration pursuant to the federal Public Readiness and Emergency
                            Preparedness ("PREP") Act ( 42 U.S.C. section 247d-6d) under which
                            licensed professionals who administer novel H1N1 influenza monovalent
                            vaccine are given broad PREP Act protection from liability for civil claims
                            other than those based on willful misconduct. Others who are given such
                            protection include government program planners and others involved in the
                            manufacture, distribution, dispensing, administration and use of the novel
                            H1N1 influenza monovalent vaccine.
                        c.  National novel H1N1 influenza monovalent vaccine supply will be:
                            i. A bolus of 45 million doses over 3-4 weeks.
                            ii. Followed by 20 million doses per week.
                            iii. Vaccine will become available in mid-October 2009.
                        d.  Two doses of vaccine will be required by most people; older adults may
                            require only 1 dose.
                        e.  The first dose will confer some degree of immunity.
                        f.  There will be no constraints on the use of the 2nd dose from Centers for
                            Disease Control and Prevention (CDC).



3
  All planning assumptions and requirements used for State planning for response to novel H1N1 influenza are included in
Attachment 2.
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                    g. Vaccine will not be held for the second dose.
                    h. Counties will have fiscal and other resources to vaccinate their identified
                       populations.
                    i. The groups targeted for vaccination are those identified by the Advisory
                       Committee on Immunization Practices (ACIP) on July 29, 2009.
                    j. Novel H1N1 influenza monovalent vaccine will be fully licensed by the
                       Food and Drug Administration (FDA), will not contain an adjuvant, and will
                       be safe and effective.
                    k. The costs of vaccine administration will be covered by some form of private
                       insurance or public funds.

                2.    Logistics/Capacity/Distribution:
                      a.   New York State will receive novel H1N1 influenza monovalent vaccine
                           from 3-5 different manufacturers at a maximum of 3627 direct ship-to sites
                           weekly.
                      b.   Vaccine will arrive in a usable condition with cold-chain maintained.
                      c.   Adjuvant will not be required for vaccine administration.
                      d.   New York City (NYC) will operate with their direct CDC allotment for all
                           entities/facilities located within the NYC boundaries.
                      e.   The available transportation resource (cold chain and dry) are available
                           through NYSDOH and/or SEMO resources.
                      f.   NYSDOH and the LHDs have adequate storage space to hold shipments.
                      g.   There is a maximum of 3627 direct ship-to sites available. LHDs and
                           Hospitals will be identified as a direct ship-to site.
                      h.   Inactivated novel H1N1 influenza monovalent vaccine will be supplied in
                           both multi-dose vials and single dose pre-filled syringes. Live attenuated
                           novel H1N1 influenza monovalent vaccine will be available in single dose
                           nasal applicators.
                      i.   Novel H1N1 influenza monovalent vaccine and ancillary supplies will be
                           delivered through different supply chains.

                3.    Allocation and Dispensing:
                      a.   Distributing vaccine to private sector partners is a way to enhance vaccine
                           use.
                      b.   The number of people returning for a second dose will be lower than those
                           that received the 1st dose.
                      c.   Schools are likely to be used as a dispensing site to vaccinate children 5- 18.
                      d.   Universities are likely to be used as a dispensing site to reach individuals
                           18- 24 years of age.
                      e.   Pharmacies will be used as a dispensing site for those 18 years and older.
                      f.   Occupational settings will be used as vaccination sites for health care
                           workers and emergency service personnel.
                      g.   NYSDOH regional staff will vaccinate their own staff.
                      h.   NYSDOH central office will vaccinate their own staff.
                      i.   Withholding Vaccine:
                           i. There will be a certain amount of vaccine withheld at the State level to
                               ensure that any identified gaps or problems that arise can be managed in
                               an effective and expeditious manner.

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                              ii. Vaccine will not be held at any level of the distribution system for those
                                  receiving a 2nd dose.

                4.    Public Information and Risk Communications
                      a.   Public health information from the CDC or Health and Human Services
                           (HHS) will be available for use prior to the fall flu season.
                      b.   NYSDOH will provide timely, accurate information on issues relating to the
                           novel H1N1 influenza monovalent vaccine, and its availability.
                      c.   Risk communication messages need to address the anticipated confusion
                           about vaccine issues including different recommendations for who should
                           receive novel H1N1 influenza monovalent vaccine vs. seasonal flu vaccine,
                           and why people older than 64 are not a priority group for novel H1N1
                           influenza monovalent vaccine.
                      d.   Individuals over the age of 65 will be a specific target audience for vaccine
                           messaging.
                      e.   Reports of adverse events temporally associated with receipt of novel H1N1
                           influenza monovalent vaccine are likely.

VI.    Concept of Operations
       A.      Activation Circumstances
                1. In collaboration with the Federal Government, NYSDOH will conduct a multi-
                    modal novel H1N1 influenza Mass Vaccination Campaign to immunize citizens in
                    accordance with the Federal Government’s prioritization recommendations to help
                    decrease the spread of disease and to minimize the severity of the novel H1N1
                    influenza.

       B.      Operational Branches
                1. Incident Management System (IMS)
                    a.   The NYSDOH’s Incident Management System (IMS) is used to respond to
                         all emergency incidents.
                    b.   The Office of Health Emergency Preparedness (OHEP) will manage the
                         classic functions of the Incident Command System (ICS) (Command,
                         Finance, Logistics, Operations, and Planning).
                    c.   Also see Attachment 3.

                2.    Vaccination
                      a.   NYSDOH has provided the Vaccination Operational Group’s Concept of
                           Operations as a separate attachment to allow the LHDs to easily develop
                           their own Mass Vaccination Campaign Plan. See Attachment 4

                3.    Healthcare Infection Control
                      a.   Evidence-based guidance will be developed for all areas of healthcare,
                           including hospitals, nursing homes, ambulatory settings, home health,
                           emergency medical services, and adult homes. Areas of concentration will
                           include prevention of healthcare associated transmission (e.g., transmission
                           based precautions) and healthcare worker protection (e.g., personal
                           protective equipment).

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                    b. Recommendations will be developed using published data, Federal
                       guidance, and local experience, in collaboration with NYSDOH and New
                       York City Department of Health and Mental Hygiene (NYCDOHMH)
                       partner workgroups and members of the healthcare community. Materials
                       will be disseminated by the NYSDOH Health Commerce System and
                       through professional organizations.
                    c. Communication of initial guidance as well as triage of ongoing issues will
                       be achieved through regular conference calls with stakeholders, healthcare
                       forums, and close monitoring of the Infection Control Bureau Mail Log
                       (BML). Modifications to recommendations will be made based on
                       epidemiologic evidence collected locally and reported by Federal and local
                       partners and stakeholders, in consultation with Public Health partners such
                       as NYCDOHMH.

                4.    Public Information & Risk Communications
                      a.   Presenting public information and risk communication regarding influenza
                           vaccination during the fall of 2009 and throughout 2010 will be challenging.
                           With both seasonal and the novel H1N1 influenza viruses circulating;
                           concern about the safety of the new vaccine, different modalities for
                           administering seasonal and novel H1N1 influenza monovalent vaccine (one
                           dose vs. two doses), different timeframe for vaccine delivery, etc., there
                           exists great potential for confusion.
                      b.   Vaccination against seasonal influenza will be recommended for everyone,
                           with a special emphasis on senior citizens. Public information and risk
                           communication strategies relating to novel H1N1 influenza vaccination will
                           evolve according to the situation:
                               i.     Limited vaccine/low demand—Communicate why we are
                                      concerned about this new virus, steps being taken to make novel
                                      H1N1 influenza monovalent vaccine available, and who is
                                      recommended to receive it when it is available; encourage use of
                                      seasonal influenza vaccine.
                               ii. Limited vaccine/high demand—Risk communication principles
                                      and approach dominate; communicate reasons for lack of vaccine
                                      and rationale for tiered approach and emphasize other protective
                                      steps.
                               iii. Ample vaccine/low demand—Social marketing approach
                                      dominates; deliver tailored and motivating messages to those
                                      recommended for vaccination; increase awareness of disease risks,
                                      communicate vaccine benefits, and address safety concerns.
                               iv. Ample vaccine/high demand—Use communication to help
                                      distribution and delivery challenges. Respond quickly to vaccine
                                      safety concerns.
                      c.   Factors that will impact demand for vaccination will include perceptions
                           regarding when and where influenza viruses are expected to begin
                           circulating coupled with what actually occurs, such as: severity and
                           visibility of initial cases; the population groups most affected and/or most
                           severely affected; and beliefs regarding personal susceptibility to severe
                           disease (e.g., are people like me becoming very ill?)

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                    d. There will be a need for redundant channels of communication to promote
                       and enhance public support for influenza vaccination in light of the many
                       uncertainties surrounding this flu season and the novel H1N1 influenza
                       monovalent vaccine. It will be crucial to coordinate messaging among
                       NYSDOH partners within the public health community, health care
                       providers and state/local political leaders to maximize their impact upon the
                       media, general public and members of vulnerable populations.
                    e. Key considerations for vaccine public information and risk
                       communication: In practice it will be difficult to differentiate between
                       seasonal and novel H1N1 influenza illness.
                           i.    Messages should prepare people for this and focus on general
                                 guidance that is applicable to all flu;
                           ii. Messages comparing novel H1N1 influenza with seasonal
                                 influenza should not inadvertently foster or support public
                                 perceptions that seasonal influenza is a mild disease.
                           iii. Many “high risk” people do not self-identify as being at high risk.
                           iv. Vaccination recommendations that involve children and pregnant
                                 women can be expected to generate heightened concern about
                                 vaccine safety.
                           v.    Older individuals may be confused and upset because they will
                                 have to wait to get the novel H1N1 influenza monovalent vaccine.
                                 Messages should prepare for this.
                           vi. Variation in vaccines and immunization
                                 recommendations/approaches will raise questions and issues.
                           vii. Variation in vaccination practices between locations/providers will
                                 raise questions and issues.
                    f. Public Information and Risk Communications Strategies - A variety of
                       strategies will be employed to support vaccine communications. These
                       include media relations, social marketing (mass media and new media),
                       internal relations, and crisis and emergency risk communication, coupled
                       with outreach to special audiences.
                           i.    Media relations: NYSDOH will conduct both proactive and
                                 reactive media relations. The Department’s Public Affairs Group
                                 (PAG) will be the sole point of contact for media inquiries. PAG
                                 staff will respond to media requests for interviews or information
                                 and will coordinate such with appropriate Subject Matter Experts.

                                    Because of the anticipated volume of media requests, the
                                    department’s public website will provide extensive information for
                                    media, including links to dates/times/location of vaccination clinics
                                    to be conducted by LHDs and Influenza Like Illness (ILI)
                                    surveillance data. PAG will also participate in a series of forums
                                    to be held across New York State early in September 2009. These
                                    will include briefings for local elected officials and members of the
                                    media.

                              ii.   Social marketing: PAG’s Bureau of Health Media and Marketing
                                    (BHMM) will coordinate health marketing strategies to promote

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                                   both seasonal vaccination and novel H1N1 influenza vaccination.
                                   Mass media approaches will include:
                                      Radio and television public service announcements;
                                      Transit campaign;
                                      Development and dissemination of educational materials such
                                      as posters and fact sheets; and
                                      Collaborating with other state agencies, LHDs, healthcare
                                      providers and commercial partners such as pharmacy chains to
                                      distribute informational materials broadly.

                                       New media also will be used. BHMM will provide content to the
                                       department’s MySpace account and will conduct vaccine education
                                       via Twitter. In collaboration with the SEMO, text messages
                                       directing NY-Alert consumers to vaccine information will be sent
                                       to all individuals who sign up to receive them.

                                iii.   Internal relations: It is important to realize that NYSDOH
                                       employees, no matter what their program area, will likely be
                                       viewed by their family, friends and neighbors as “experts” when an
                                       important health issue is of continued media interest. NYSDOH
                                       employees will receive information about vaccination issues via
                                       The Insider, DOH NEWS, and as necessary, email messages from
                                       Dr. Daines.

                                iv.    Crisis and Emergency Risk Communication (CERC): CERC staff
                                       from the Office of Science will work to ensure that overarching
                                       principles of Crisis and Emergency Risk Communication are
                                       incorporated in all public communication relating to influenza
                                       vaccination. These core principles are:
                                           Acknowledge uncertainties and the unpredictable nature of
                                           influenza.
                                               o Recognize the amount of uncertainty is more than
                                                    everyone would like.
                                               o Trust the public to tolerate incomplete and potentially
                                                    upsetting information.
                                               o Give anticipatory guidance.
                                           Share challenges and dilemmas.
                                           Direct fears and concerns (vs. attempting to minimize them).
                                           Maintain transparency and communicate early and frequently.
                                           Use multiple channels and partners to increase reach and
                                           visibility of recommendations and messages.

                                       CERC staff will develop and/or review NYSDOH vaccination
                                       messages to ensure that they reflect these principles.

                                v.     Vulnerable audiences are defined as individuals or groups who can
                                       not or will not receive a message; can not or will not understand a
                                       message or can not or will not act upon a message because of

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                                    special needs. Among these are physical or mental disabilities,
                                    issues relating to culture, ethnicity, geographic isolation, age, or
                                    economic status.

                                       BHMM staff who are assigned to work on CERC issues will be
                                       responsible for incorporating strategies to reach vulnerable
                                       audiences, including but not limited to: ensuring that informational
                                       materials are also available in languages other than English; in
                                       reading levels appropriate for low literacy audiences; and in
                                       formats customized for individuals who have impaired sight or
                                       hearing. In addition to mass media, alternate channels for
                                       information dissemination will be employed. Examples are:
                                       cascading information via NYSDOH programs that regularly work
                                       with vulnerable populations through staff and/or contractors and
                                       identifying and providing information and education to trusted
                                       leaders and organizations and peers within target communities.

                      g.      Public information for pharmaceutical and non-pharmaceutical
                              interventions - Traditional and new media strategies (Television, radio and
                              outdoor advertising, web-based information, MySpace, Twitter) as well as
                              use of non-media channels of communication such as cascading information
                              via NYSDOH programs that serve vulnerable populations; outreach to local
                              opinion leaders including representatives of faith-based and community
                              based organizations, and partnerships with commercial entities such as
                              pharmacies and retail outlets will be pursued to broaden public acceptance
                              of vaccination and non-pharmaceutical interventions to reduce the risk of
                              getting or spreading influenza.
                      h.      Joint Information Center (JIC) - If a JIC is required, it will be established
                              per direction of the Governor's Communication Office and coordinated by
                              the SEMO. A JIC likely will be "virtual" rather than have a physical
                              presence. NYSDOH PAG or CERC staff will provide support to a State JIC
                              should one be established. SEMO's Public Affairs Officer (PIO) will be
                              responsible for requesting other State Agency PIO support via the
                              appropriate channels.

                5.    Legal Issues
                      a.    NYSDOH attorneys may not give specific legal advice to counties, LHDS,
                           health care facilities, providers, or other planning partners in the health care
                           community. To the extent these groups seek legal advice; they will be
                           directed to consult with their own attorneys.
                      b.   NYSDOH attorneys will provide guidance as requested on relevant areas of
                           law including, but not limited to, issues surrounding the effect of any
                           federal, state, or local declaration of emergency, the applicability of the
                           PREP Act, the impact of any Emergency Use Authorizations (EUA), inter-
                           jurisdictional cooperation, the use of volunteers, privacy, informed consent
                           and scope of practice.



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                     c. As necessary, information will be made available to LHDs, providers and
                        planning partners to advise of relevant legal developments at the federal and
                        state level.

VII. Federal Agencies
       A.      New York State may request personnel and/or resources from the following Federal
               partners:

              1.    HHS: HHS is the United States government's principal agency for protecting the
                    health of all Americans and providing essential human services, especially for those
                    who are least able to help themselves.

              2.    CDC: CDC’s mission is to collaborate to create the expertise, information and tools
                    that people and communities need to protect their health – through health
                    promotion, prevention of disease, injury and disability, and preparedness for new
                    health threats.

              3.    Federal Emergency Management Office (FEMA): FEMA’s mission is to support
                    our citizens and first responders to ensure that as a nation we work together to build,
                    sustain, and improve our capability to prepare for, protect against, respond to,
                    recover from and mitigate all hazards.
                      a.     Statutory Authority: Robert T. Stafford Disaster Relief and Emergency
                             Assistance Act, PL 100-707, signed into law November 23, 1988; amended
                             the Disaster Relief Act of 1974, PL 93-288. This Act constitutes the
                             statutory authority for most Federal disaster response activities especially as
                             they pertain to FEMA and FEMA programs.




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Attachment 1: Record of Change

Date of         Name or Program       Change Summary
Change




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Attachment 2: NYSDOH Novel H1N1 Influenza Vaccine Workgroup Planning
Requirements & Assumptions

                         These planning assumptions are subject to change

                                          September 8, 2009

I. Plans & Planning Requirements

A. Planning Requirements

   1. At a minimum the following plans and guidance documents will be developed and provided to
      the respective target audience:

B. Plans
   1. Novel H1N1 Influenza Mass Vaccination Campaign Plan
   2. Novel H1N1 Influenza Education Plan

C. Guidance Documents

   1. Clinical Management
         a. Guidance for clinicians on clinical assessment, testing, treatment and prophylaxis.
         b. Guidance for clinicians on special populations, including children, pregnant women and
             patients with chronic diseases.
         c. Planning checklist for clinicians in the outpatient setting about preparing for the influenza
             season.
         d. Fact sheets for patients on:
         e. reducing the spread of influenza
         f. caring for someone ill at home with influenza
         g. antiviral medications
         h. influenza testing
         i. Guidance to the Office of Health Emergency Preparedness on the clinical issues of the
             Strategic National Stockpile (SNS), Medical Emergency Response Cache (MERC) and
             Emergency Use Authorization (EUA).
         j. Guidance to managed care plans and insurance plans about ensuring adequate coverage
             of antiviral medications and other services that may be part of the H1N1 response.
         k. Guidance for providing antiviral medications for uninsured persons, including referrals to
             FQHCs, enrollment in public health plans and distribution of expiring MERC supplies.

   2. Community Mitigation
        l. Guidance on: Mitigation Triggers
        m. Guidance on: Policy and procedures for school closures
        n. Guidance on: Mask Use

   3. Healthcare Infection Control
         a. Guidance on: Infection control practices to include: Hospitals, Long Term Care, EMS,
            Outpatient

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   4. Healthcare Surge/Triage
         a. Guidance on: Acute care hospitals
         b. Guidance on: Non-symptomatic individuals

   5. Public Information & Risk Communications
         a. Guidance documents for State and Local Health Departments

   6. Surveillance
         a. Guidance on: Statewide influenza surveillance system for Novel H1N1 Influenza virus
         b. Guidance on: Monitoring the prevalence and severity in:
             • Hospitals
             • Healthcare facilities
             • Schools
             • Children’s camps

II. General

A. Planning Assumptions

   1. Novel H1N1 influenza will recur in epidemic form this Fall/Winter and clinical disease severity
       at an individual patient level will remain the same.
   2. Novel H1N1 monovalent vaccine will be administered under a declaration pursuant to the federal
       Public Readiness and Emergency Preparedness ("PREP") Act ( 42 U.S.C. section 247d-6d)
       under which licensed professionals who administer novel H1N1 vaccine are given broad PREP
       Act protection from liability for civil claims other than those based on willful misconduct. Others
       who are given such protection include government program planners and others involved in the
       manufacture, distribution, dispensing, administration and use of the novel H1N1 influenza
       monovalent vaccine.
   3. National novel H1N1 influenza monovalent vaccine supply will be:
           a. A bolus of 45 million doses over 3-4 weeks.
           b. Followed by 20 million doses per week.
           c. Vaccine will become available in mid-October 2009.
   4. Two doses of vaccine will be required by most people; older adults may require only 1 dose.
   5. The first dose will confer some degree of immunity.
   6. There will be no constraints on the use of the 2nd dose from Centers for Disease Control and
       Prevention (CDC).
   7. Vaccine will not be held for the second dose.
   8. Counties will have fiscal and other resources to vaccinate their identified populations.
   9. The groups targeted for vaccination are those identified by the Advisory Committee on
       Immunization Practices (ACIP) on July 29, 2009.
   10. Novel H1N1 influenza monovalent vaccine will be fully licensed by the Food and Drug
       Administration (FDA), will not contain an adjuvant, and will be safe and effective.
   11. The costs of vaccine administration will be covered by some form of private insurance or public
       funds.




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B. Logistics/Capacity/Distribution

Planning Requirements

   1. Public health will retain control over decisions on vaccine allocation/distribution within the state.
   2. A hybrid system using both the SNS plan and centralized distribution through CDC will be
      utilized.
   3. The Strategic National Stockpile (SNS) Plan will be used to coordinate the receipt, tracking, and
      shipping of vaccine and vaccine related assets that are distributed via the State.
   4. Vaccine (and identified ancillary supplies) shipped to the State will be received at a State
      identified site with any other pandemic assets being received at another State identified site in
      accordance with the NYS Strategic National Stockpile (SNS) plan.

Planning Assumptions

   1. New York State will receive novel H1N1 influenza monovalent vaccine from 3-5 different
      manufacturers at a maximum of 3627direct ship-to sites weekly.
   2. Vaccine will arrive in a usable condition with cold-chain maintained.
   3. Adjuvant will not be required for vaccine administration.
   4. New York City (NYC) will operate with their direct CDC allotment for all entities/facilities
      located within the NYC boundaries.
   5. The available transportation resource (cold chain and dry) are available through NYSDOH
      and/or SEMO resources.
   6. NYSDOH and the LHDs have adequate storage space to hold shipments.
   7. There is a maximum of 3627 direct ship-to sites available. LHDs and Hospitals will be
      identified as a direct ship-to site.
   8. Inactivated novel H1N1 influenza monovalent vaccine will be supplied in both multi-dose vials
      and single dose pre-filled syringes. Live attenuated novel H1N1 influenza monovalent vaccine
      will be available in single dose nasal applicators.
   9. Novel H1N1 influenza monovalent vaccine and ancillary supplies will be delivered through
      different supply chains.

C. Allocation and Dispensing (including Critical Infrastructure and Prioritization)

Planning Requirements

   1. The allocation will be pro rata to the extent possible.
   2. Vaccine will not be administered under the conditions of a EUA.
          a. The vaccine will be fully licensed
   3. Traditional and non-traditional public and/or private sites will be used (i.e. private health care
      provider offices, clinics, points of dispensing (PODs), pharmacies, community buildings, schools
      etc.).
          a. The location of vaccine administration will be based on county of residence, occupational
              group, and location of healthcare facilities
          b. Trigger points for using certain private sites will be identified
   4. Vaccine will be administered consistent with ACIP target group recommendations that were
      voted in as recommendations on July 29, 2009. This vaccine priority will be mandated by the
      State Health Commissioner as a Standard of Medical Care.

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          a. The allocation will consider pregnant women, care takers of infants <6 months of age,
              individuals age >= 6 months to 24 years of age, those with high risk conditions aged 24-
              65 years, and health care workers and emergency service personnel, (based upon latest
              ACIP/federal guidance).
          b. Department of Defense (DoD) uniformed active duty and mission critical personnel will
              be vaccinated by the VA Healthcare System and some non-DOD will also be vaccinated
              by the VA.
   5. Plans will need to be made to reach special populations such as Indian Nations, Amish, other
      religious groups, etc.

Planning Assumptions

   1. Distributing vaccine to private sector partners is a way to enhance vaccine use.
   2. The number of people returning for a second dose will be lower than those that received the 1st
      dose.
   3. Schools are likely to be used as a dispensing site to vaccinate children 5- 18.
   4. Universities are likely to be used as a dispensing site to reach individuals 18- 24 years of age.
   5. Pharmacies will be used as a dispensing site for those 18 years and older.
   6. Occupational settings will be used as vaccination sites for health care workers and emergency
      service personnel.
   7. NYSDOH regional staff will vaccinate their own staff.
   8. NYSDOH central office will vaccinate their own staff.
   9. Withholding Vaccine:
          a. There will be a certain amount of vaccine withheld at the State level to ensure that any
              identified gaps or problems that arise can be managed in an effective and expeditious
              manner.
          b. Vaccine will not be held at any level of the distribution system for those receiving a 2nd
              dose.

D. Clinical Issues

Planning Requirements

   1. Adverse Event Monitoring and Reporting:
         a. VAERS will remain the major reporting mechanism.
         b. There will be an “enhanced VAERS” system for the Fall that will be web-based.
         c. VAERS will be supplemented by additional surveillance and studies to rapidly evaluate
             the safety of the vaccination program.
         d. Guillain Barre Syndrome will be made reportable to New York State.
         e. Statewide monitoring of GBS may occur through hospitals.
         f. Active surveillance for GBS will occur.
         g. A clinical data collection system (CDMS or NYSIIS) will be used to capture the
             minimum required data elements (patient’s date of birth, POD ID, and date of clinic)
         h. NYSDOH has identified a vaccine safety coordinator as well as a back-up vaccine safety
             coordinator to oversee reporting policies, methodologies, and procedures as well as to
             ensure the adverse events are reported to VAERS and follow-up appropriately
   2. Use of PODs


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         a. The location of vaccine administration will be based on county of residence, occupation
             group, location of primary care provider and location of healthcare facilities
   3. Non-patient specific standing orders will be used for mass vaccination clinics.
   4. Public and private school facilities will be used as mass vaccination sites.
         a. A recommended standardized parental consent form will be provided by the State.
   5. Training
         a. Job action sheets have been created for all clinic roles, and a just-in-time training guide
             has been integrated into the NYSDOH Mass Dispensing Guide (MDG).
         b. Clinical training will continue to be provided to State and local public health providers
             including specifics regarding the Novel H1N1 Influenza vaccine.
         c. A vaccination training plan will be developed

Planning Assumptions

   1. Novel H1N1 Influenza vaccine will not contain adjuvents, and will be a fully licensed vaccine.

E. Workforce and Partners

Planning Requirements

   1. Partners will be included in planning process.
   2. Healthcare facilities will vaccinate their staff.
   3. Hospitals, Medical Reserve Corps (MRCs) and LHDs will work together to identify and recruit
      medical and non-medical volunteers who can assist in healthcare settings or PODs.
   4. Pharmacists/Pharmacies:
          a. Can vaccinate as a volunteer enrolled in a LHD volunteer program or a MRC
          b. Can vaccinate if standing order or patient specific order is signed by local physicians.

Planning Assumptions

   1. Private sector will need to vaccinate.
          a. Adult providers will need to be educated and trained
          b. OBGYNs will be vaccinators.
          c. Pediatricians and family physicians will be vaccinators
   2. LHDs will agree to vaccinate individuals who have no medical home or lack health insurance.
   3. Private Mass Vaccinators (companies such as Maxim, etc.):
          a. Will accept health insurance or “cash and carry”, unless under contract with NYSDOH
          b. Will not accept Medicaid
          c. Do not have a discount program for low-income/non-insured
          d. Will vaccinate in schools, but only following “cash and carry” process
          e. An administrative fee (possibly $15.00) will be charged

F. Information Technology

Planning Requirements

   1. Vaccine administration will be tracked through the existing CRA system, using NYSIIS or Clinic
      Data Management System (CDMS).

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   2.   All organizations, providers and practitioners who need to report through NYSIIS, CDMS, or
        report information related to vaccine inventory, antivirals or any other data required by OHEP
        will be identified and have established a cadre of staff with:
            a. Access to the HPN
            b. Up to date information in the Communications Directory
            c. Training in all the applications and systems they need to use on the HPN
            d. Have sufficient HPN coordinators to handle additional requests for access within their
                organization
   3.   The existing set of services to permit automated and real-time exchange of data and information
        between ALL response systems, including NYSIIS, CDMS, ECLRS, dashboard, and HERDS
        will be used.
   4.   An Event Data Management Plan (EDMP) is in place that assures (through the dashboard) that
        we have:
            a. One-stop shopping, real-time, access to ALL needed event data and information in
                standardized and dynamic forms for decision support within DOH IMS and for non-
                trivial situational awareness by our response partners (LHDs, hospitals, etc.)
   5.   Individual level data collection will be required for every dose of vaccine administered,
        regardless of the age of the recipient.
   6.   Consent to collect and store information in a statewide database accessible to authorized users
        will be required for persons 19 years and older.
   7.   There will be a Dashboard to track supply chain issues for PPE, AV, etc.

Planning Assumptions

   1. Additional information technology support services may need to be developed (i.e. adverse event
      tracking services, etc.).

G. Public Information and Risk Communications

Planning Requirements

   1. Public health information will be developed and distributed to target audiences as required.
   2. NYSDOH will share information with the public as quickly as possible in its role as the lead
      health authority in NY.
   3. A public health information campaign will be developed and constantly updated as new vaccine
      information becomes available.
   4. Messages and activities to promote the Novel H1N1 Influenza vaccine will be coordinated with
      messages on the seasonal flu vaccine.
   5. Novel H1N1 Influenza vaccination messages will emphasize the groups of people who are at
      highest risk of complications from influenza.
   6. Novel H1N1 Influenza vaccination messages will anticipate coincidental morbidity and mortality
      and address this issue prior to the vaccine campaign.

Planning Assumptions

   1. Public health information from the CDC or Health and Human Services (HHS) will be available
      for use prior to the fall flu season.


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   2.   NYSDOH will provide timely, accurate information on issues relating to the novel H1N1
        influenza vaccine, and its availability.
   3.   Risk communication messages need to address the anticipated confusion about vaccine issues
        including different recommendations for who should receive novel H1N1 influenza monovalent
        vaccine vs. seasonal flu vaccine, and why people older than 64 are not a priority group for novel
        H1N1 influenza monovalent vaccine.
   4.   Individuals over the age of 65 will be a specific target audience for vaccine messaging.
   5.   Reports of adverse events temporally associated with receipt of novel H1N1 influenza
        monovalent vaccine are likely.

H. Health Care Facilities Planning

Current Status

   1. Hospitals have HPOD plans, developed 2006-2007 from the Point of Dispensing Standard
      Operating Guide (POD SOG) model. These plans include operational capacity are geared to
      prophylax and or treat their staff + staff family + patients in a max of three (3) days. Thus
      capacity should exceed demand since family will NOT be included in the target population.
      Recent hospital specific staff numbers are available.
   2. Most hospitals have and do use POD design to distribute seasonal influenza vaccine, but may not
      have established through put data based on rigorous exercises.
   3. Community Health Center POD capabilities are largely unknown. Since ample number and type
      of medical providers on staff, should be capable, POD planning materials will be provided to
      them.

   4. Non acute HCF POD capabilities are largely an unknown.
           a. Nursing homes should be capable to operate in a medical model and have nursing on
               staff. Outreach/education may be needed.
           b. ACFs operate on a social model. Outside assistance, in the form of mobile POD teams,
               may be necessary to successfully reach this population of HCP. Outreach/education may
               be needed.
           c. Home care providers - Outside assistance, in the form of mobile POD teams, may be
               necessary to successfully reach this population of HCP.
           d. Nursing homes and adult care facilities are not accustomed to requesting and or receiving
               deployments from LHDs. Outreach/Education may be needed.
   5. Recent hospital specific staff + family + patient data are available. Analogous data for nursing
      homes, adult care facilities, and CHCs are not currently available.
   6. It is not readily known how many hospital POD plans include push, pull or combinations of
      methods.

Planning Requirements

     1. Healthcare facilities (HCF) and HCW planning must include consideration of hospitals,
        nursing homes, adult care facilities, and community health centers (CHCs).


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     2. A coordinated response with NYCDOHMH must be achieved to ensure that HCFs are
        addressed.

     3. Considerable logistical planning and follow up may be needed depending on relationship of
        second vaccine (strength, lots, and reactions to first) to the first.
     4. Outreach education to healthcare facilities (other than hospital) will be necessary prior to the
        Fall to ensure their inclusion in County-level SNS planning.
     5. HCFs will need to develop internal allocation and follow-up systems (who, when, hold until
        have larger amounts, admin to small numbers as product arrives, etc.) to administer the vaccine
        coordinated with the supply and shipment of vaccines by NYSDOH.
     6. All HCFs must have a triage plan for the ill/mildly ill to divert patients away from their EDs.
     7. All acute care facilities will be required to have a triage plan that will divert non-ill patients
        away from the Emergency Department (ED) and establish a surge system to medically screen
        those presenting with influenza like illness.
     8. Pre-defined triggers will be established to initiate activation of the acute care hospitals medical
        command systems and triage medical surge plans.
     9. A near real-time information system will be operational by September 1, 2009 that will provide
        situational awareness on healthcare facility ED utilization and critical asset availability.

Planning Assumptions

     1. Based on a minimum of 3 vaccinations (1 seasonal flu and 2 Novel H1N1 Influenza) to give
        prophylaxis to health care workers and patients to seasonal and Novel H1N1 Influenza flu,
        HCFs will need to operate PODS for a minimum of two to three cycles, each of 2-3 days in
        duration.
          a. POD sessions may need to be shift dependent
     2. Novel H1N1 Influenza vaccine will arrive to counties and health care facilities (HCF) in
        increments. HCFs will have an allocation system to administer the vaccine that will address at
        least the following:
          a. To whom, when, whether or not to hold until larger amounts arrive, whether to
               administer to small numbers as they arrive, etc.
     3. Health care worker absenteeism, incident related or not, will impact HCFs abilities to staff a
        POD for multiple days and multiple cycles.
     4. Hospitals, nursing homes, and CHCs may experience space and management problems
        depending on the size of shipments and duration of storage. The impact on adult care facilities
        is not known.




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Attachment 3: NYSDOH Incident Management System (IMS)




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Attachment 4: NYSDOH Concept of Operations for Mass Vaccination
Campaign during the Novel H1N1 Influenza Pandemic

The sections in this Concept of Operations (Attachment4) have been kept together to allow
for LHDs and healthcare partners to use this attachment as a stand alone document to
enhance their planning activities and develop their Mass Vaccination Campaign Plans.

       I.      Overview
       II.     Objectives
       III.    Seasonal Influenza Vaccine
       IV.     Novel H1N1 Influenza
       V.      Target Groups
       VI.     Logistics
       VII.    Allocation and Dispensing
       VIII.   Vaccine Monitoring
       IX.     Clinical Management
       X.      Information Technology in Support of Vaccine Distribution
       XI.     Guidance For Local Health Departments
       XII.    Resources


       Appendices:
       A. Regulations for Health Care Personnel
       B. Prevention and Control of Seasonal Influenza with Vaccines
       C. Comparison of Target Groups for Seasonal Influenza Vaccine with Target Groups
          for Novel H1N1 Vaccine
       D. MMWR for H1N1 Vaccine
       E. Pediatric and Health Care Provider Letters & NYSIIS Fact Sheet
       F. Mass Clinic Planning
       G. School Vaccination Tool Kit
       H. List of Nursing Schools and Schools of Public Health
       I. NYSIIS Compatible Billing Software
       J. DRAFT HRI Mass Vaccinator Contract




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I. Overview

Influenza vaccination is the primary means to prevent influenza, its transmission, and associated
complications. During this novel H1N1 influenza pandemic, vaccine against the circulating
pandemic virus strain will be a major focus of pandemic response efforts. Ensuring rapid,
efficient, and equitable distribution of vaccine is central to pandemic planning. The mass
vaccination program will be key to reducing the morbidity and mortality resulting from the
pandemic and to minimize social disruption by maintaining essential services. The novel H1N1
influenza monovalent vaccine is likely to become available in mid October, 2009; the supply is
expected to be limited during the early stages of production. Furthermore, it is likely that two
doses of vaccine will be required to achieve a protective response. Therefore, when vaccine
becomes available it is essential that it be distributed in an equitable and consistent manner
across New York State.

The five manufacturers of seasonal influenza vaccine are in the process of manufacturing the
novel H1N1 influenza monovalent vaccine. The number of doses available depends on number
of factors including manufacturing capacity, the amount of antigen needed per dose for a
protective immune response, the number of doses required for each individual and how quickly
regulatory review will occur. Clinical trials are ongoing to evaluate clinical response, safety, and
possible use of an adjuvant in the vaccine. Results of the trials are expected to begin to be
available in late September, 2009.

In the past the New York State Department of Health (NYSDOH) and the Department of Health
and Human Services (HHS) and the National Vaccine Advisory Committee (NVAC), in
cooperation with the Centers for Disease Control and Prevention (CDC) and the Advisory
Committee on Immunization Practices (ACIP), have worked to provide guidance on
prioritization during a possible pandemic. However, the specific epidemiology of the novel
H1N1 influenza pandemic has dictated that a different set of target groups for vaccination be
identified. In July, ACIP made recommendations that five target groups be the first to receive
vaccine: pregnant women, household contacts and caregivers of infants less than six months,
health care and emergency medical services personnel, persons aged six months through 24
years, and adults aged 25 through 64 years of age with a medical condition that places them at
high risk for complications of influenza. The New York State novel H1N1 influenza monovalent
vaccination campaign will first target those five groups.

Two ongoing activities engaged in by the NYSDOH, Local Health Departments (LHDs) and
health care partners are essential for pandemic preparedness. These are annual influenza
vaccination campaigns and emergency preparedness planning. The strength of the annual
influenza vaccination program should improve the success of the pandemic influenza vaccination
program. Higher annual vaccination rates will foster increased familiarity with and confidence
in influenza vaccines, increased immunization manufacturing capacity and strengthened
distribution channels. In addition, the work already completed on developing plans for
emergency mass distribution of medical supplies provides the basis for developing local
pandemic vaccination plans. The promotion of the appropriate use of pneumococcal vaccine is
also important so that vulnerable populations will be protected from pneumococcal pneumonia, a
serious sequela to influenza infection.

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This plan provides recommendations on planning for the necessary elements of the mass
campaign for novel H1N1 influenza monovalent vaccination program. Objectives specific to
vaccine use are outlined and guidelines for target groups are included. Also included are plans
for vaccine procurement and distribution, vaccine safety monitoring and data collection.


II.      Objectives
      A. Overall: To ensure that all New Yorkers have access to Novel H1N1 Influenza
         monovalent vaccine according to ACIP target groups.

         • Make the novel H1N1 influenza monovalent vaccine available in a manner consistent
             with the Federal government’s prioritization recommendations;
         •   Use a combination of strategies to administer vaccine: mass clinics, school based
             clinics, hospitals, community health centers, private providers, pharmacists and
             others;
         •   Administer the novel H1N1 influenza monovalent vaccine only if it is found to be
             safe and is likely to be effective in preventing novel H1N1 influenza virus infection;
         •   Assure that the ACIP recommendations for vaccine administration groups will be a
             medical standard of care;
         •   Ensure efficient and equitable distribution of novel H1N1 influenza monovalent
             vaccine;
         •   Monitor vaccine use and safety during the pandemic to assure that the benefits
             outweigh the risks;
         •   Collect appropriate data on vaccine allocation, distribution, administration and safety;
         •   Create materials and opportunities to enable the public and providers to access
             information on vaccine use and availability.

III.     Seasonal Influenza Vaccine

The strength of annual seasonal influenza vaccination activities is important to the success of the
novel H1N1 influenza vaccination program. Higher seasonal vaccination rates fosters increased
familiarity with and confidence in influenza vaccines, increased immunization manufacturing
capacity, and strengthened distribution channels. The NYSDOH has consistently made seasonal
influenza vaccination a priority and has increased the scope and depth of its seasonal influenza
program.

This year during the upcoming influenza season, vaccination with seasonal influenza vaccine
takes on increased importance. It is expected that disease due to the expected circulating
influenza viruses and the disease due to the novel H1N1 influenza virus will occur at the same
time. In addition, vaccination with seasonal influenza vaccine and novel H1N1 influenza
monovalent vaccine will overlap. This will make communicating with both the public and
medical providers both important and challenging. In addition, with the possibility of increased
incidence of influenza disease, even if mild, it is important that seasonal influenza vaccine be
given widely in order to decrease illness, preserve societal functions and to keep the health care
system operating.
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A key message for this influenza season is for people to get and medical providers to give the
seasonal vaccine as soon as it is available. This will enable all individuals to become protected
against seasonal influenza and will facilitate the administration of novel H1N1 influenza
monovalent vaccine when it becomes available. It is expected that the novel H1N1 influenza
monovalent vaccine will require two doses. Some children (those under nine years of age being
vaccinated for the first time) will need four vaccines: two seasonal and two novel H1N1. Adults
will probably need three vaccines: one seasonal and two novel H1N1. Starting seasonal
vaccination as early as possible will ensure that all individuals have the opportunity to receive all
necessary doses.

Seasonal influenza vaccine supply is expected to be between 115 and 120 million doses for the
country as a whole. This amount is more than has ever been used in the United States.
Therefore, seasonal influenza vaccine should be available to all who wish to be vaccinated.
Distribution of seasonal influenza vaccine has already begun in August, 2009 and it is expected
that about 90% of this vaccine will be shipped by the manufacturers by November 1, 2009.

    A. Emergency Regulations for Vaccination of Health Care Personnel

On August 13, 2009 emergency regulations went into effect that require that all personnel
in certain health care settings receive annual vaccinations against influenza by November
30 of each year unless they have a medical contraindication to the vaccination or the State
Commissioner of Health determines that there is an insufficient supply of vaccine for the
year. The primary purpose of this regulation is to protect the health and safety of
vulnerable patients, whose risk of serious adverse effects from influenza is high. An added
benefit is to maintain a healthy workforce during flu season.

The new regulation applies to:
   • Hospitals
   • Diagnostic and treatment centers licensed under Article 28
   • Home care services agencies licensed under Article 36 of the Public Health Law
      including:
          o Certified home health agencies
          o Licensed home care services agencies
          o Long-term home health programs including AIDS home care programs
   • Hospice programs certified under Article 40 of the Public Health Law.

Personnel who must be vaccinated against influenza include all those affiliated with the
employer, paid or unpaid, who have direct contact with patients or whose activities are
such that they pose a risk of transmission of influenza to patients or to those who provide
direct care to patients. “Personnel” is defined as anyone affiliated with any organization
(noted above), including but not limited to employees; members of the medical staff,
including attending physicians; contract staff; students and volunteers.

A copy of the regulations, a letter sent to administrators of affected facilities, and a set of
questions and answers on the regulations can be found in Appendix A.


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   B. Seasonal Influenza Vaccination Activities

The NYSDOH seasonal influenza vaccination program is coordinated by the Bureau of
Immunization, located in the Division of Epidemiology. Each year the Bureau creates an
influenza work plan that outlines all activities that are anticipated to be completed. The
work plan encompasses the following areas of activities:
    • Education;
    • Maintenance of influenza centered websites;
    • Use of print, radio, and internet-based media to promote influenza vaccination;
    • Collaboration with influenza partners within and outside of the NYSDOH;
    • Vaccination of health care personnel;
    • Promotion of pharmacists as immunizers;
    • Promotion of vaccination of individuals with chronic diseases;
    • Promotion of vaccination of all children aged 6 months to 18 years;
    • Promotion of vaccination to those individuals 65 years of age and older; and
    • Regulatory and legal issues related to influenza vaccination.


For information on recommendations for seasonal influenza vaccine please see the
Prevention and Control of Seasonal Influenza with Vaccines, MMWR July 31, 2009 /
58(RR08); 1-52 in Appendix B.

   C. Pneumococcal Vaccine

Secondary bacterial pneumonia is the most common complication of influenza. For this reason it
is important that all those who are recommended to receive the pneumococcal vaccine get
immunized as soon as possible. Young infants usually receive all the pneumococcal conjugate
vaccine doses by the time they are 15 months of age, though children up to 59 months of age can
be vaccinated. Persons 2 years of age and up can also receive the pneumococcal polysaccharide
vaccine (PPSV) if they have the following:
    • Chronic illness,
    • Anatomic or functional asplenia
    • An immunocompromising condition,
    • HIV infection,
    • Environments or settings with increased risk,
    • Cochlear implant.

In addition, all persons aged 65 years and older should get one PPSV.

For more information on pneumococcal disease please visit the CDC website at
http://www.cdc.gov/vaccines/vpd-vac/pneumo/default.htm.




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IV.    Novel H1N1 Influenza Monovalent Vaccine
   A. General Information on the Novel H1N1 Influenza Monovalent Vaccine

Novel H1N1 influenza monovalent vaccine is being produced by the same five manufacturers
that produce seasonal influenza vaccine. This vaccine is expected to:

   •   Be manufactured and formulated just like seasonal influenza vaccine but with a change in
       the influenza strain that is included;
   •   Contain only antigens from the novel H1N1 influenza strain (i.e. is monovalent);
   •   Be a fully FDA-licensed vaccine;
   •   Be available in both the injectable form and the nasal spray;
   •   Be available in limited quantities without thimerosal;
   •   Become available mid to late October, 2009, though some doses may be available as
       early as September, 2009;
   •   Require 2 doses, a minimum of 3 weeks apart;
   •   Be provided at no cost by the Federal government;
   •   Be able to be given simultaneously with seasonal influenza vaccine; and
   •   Be safe and effective.

It is assumed that initial doses of novel H1N1 influenza monovalent vaccine will not contain an
adjuvant, an immune booster. If adjuvanted vaccine becomes available, its use will be subject to
an Emergency Use Authorization (EUA) from the Secretary of the U.S. Department of Health
and Human Services. Use under a EUA will likely have additional requirements for
documentation and consent.

   B. The Timeline for the Development of Novel H1N1 Influenza Monovalent Vaccine

The novel H1N1 influenza monovalent vaccine is currently being manufactured by all five
manufacturers and is simultaneously undergoing clinical trials. The clinical studies will help to
finalize the final dosage of antigen in the vaccine, the number of doses required, the interval
between the doses, any safety concerns, antibody responses to the vaccine and other clinical
information. The first information from the trials is expected to be available sometime in
September, 2009.

The vaccine is expected to be available in mid to late October, 2009, though some amount of
doses may become available in September, 2009. It is not yet clear who would be targeted to
receive any doses that become available in September, 2009. Though the early doses may be
available before the results from the clinical trials are completed, that should not cause concern
because the novel H1N1 influenza monovalent vaccine is being produced just like seasonal
vaccine, for which clinical trials are not done. In fact, seasonal influenza vaccine already
contains an H1N1 strain of the influenza virus, though it is sufficiently different from the novel
H1N1 virus that a new vaccine is needed. The efficacy and safety profile of the new vaccine is
expected to be very similar to seasonal influenza vaccine. The safety and efficacy studies that are


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underway are more extensive than what is usually done with the licensing of seasonal influenza
vaccine.

The exact amount of novel H1N1 influenza monovalent vaccine that will become available in
September or October, 2009 is not known yet. However, some predictions are being made. The
latest information available from the CDC states that about 45 million doses will be available to
the nation as a whole first as a “bolus” over several weeks in October, 2009. Then vaccine will
be produced at a rate of 20 million doses per week.


V.       Target groups
     A. Target Groups for Novel H1N1 Influenza Monovalent Vaccine

The ACIP met on July 29, 2009 and made recommendations on who should receive the novel
H1N1 influenza monovalent vaccine and in what order they should receive it.

Considerations regarding the epidemiology of the novel H1N1 influenza monovalent vaccine
that were used to create the target groups included:
    • Which groups had the most severe illness and risk for complications during the novel
       H1N1 influenza outbreak;
    • Which groups had the greatest frequency of illness during the initial novel H1N1
       influenza outbreak in Spring, 2009;
    • The contribution of particular groups to the overall burden of severe illness;
    • Protection of healthcare system functions;
    • Reduction of societal impact; and
    • The potential for indirect protection of more vulnerable contacts.

     B. The following groups of people are in the first target groups for the novel H1N1
        influenza monovalent vaccine:

     •   Pregnant women because they are at higher risk of complications and can potentially
         provide protection to infants less than 6 months who cannot be vaccinated;
     •   Household contacts and caregivers for children younger than 6 months of age
         because younger infants are at higher risk of flu-related complications and cannot be
         vaccinated. Vaccination of those in close contact with infants less than 6 months old
         might help protect infants by “cocooning” them from the virus;
     •   Healthcare and emergency medical services personnel because infections among
         healthcare workers have been reported and this can be a potential source of infection for
         vulnerable patients. Also, increased absenteeism in this population could reduce
         healthcare system capacity;
     •   All people from 6 months through 24 years of age
             o Children from 6 months through 18 years of age because there have been
                many cases of novel H1N1 influenza in children and they are in close contact
                with each other in school and day care settings, which increases the likelihood of
                disease spread, and


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           o   Young adults 19 through 24 years of age because there have been many cases
               of novel H1N1 influenza in healthy young adults who often live, work, and study
               in close proximity and are a frequently mobile population; and,
   •   Persons aged 25 through 64 years who have health conditions associated with higher
       risk of medical complications from flu, including persons with cancer, blood disorders
       (including sickle cell disease), chronic lung disease [including asthma or chronic
       obstructive pulmonary disease (COPD)], diabetes, heart disease, kidney disorders, liver
       disorders, neurological disorders (including disorders of the nervous system, brain or
       spinal cord), neuromuscular disorders (including muscular dystrophy and multiple
       sclerosis), and people with weakened immune systems (including people with AIDS or
       those who are receiving chemotherapy.

If the initial supply of novel H1N1 influenza monovalent vaccine is limited either nationally or
on a local basis and there is not enough vaccine to cover the groups above, then the following
groups of people will be recommended to receive this vaccine:
     • Pregnant women;
     • Household contacts and caregivers of infants younger than 6 months of age;
     • Health care personnel and emergency medical services personnel who have direct patient
         contact;
     • Children 6 months through 4 years of age; and
     • Children and adolescents 5 through 18 years of age with a medical condition that makes
         them at high risk for complications of influenza;

Once it has been shown that there is enough vaccine to immunize the groups above, the next
target group is:
    • All adults from 25 through 64 years of age.

Once it has been shown that there is enough vaccine to immunize the groups above the next
target group is:
    • All adults 65 years of age and older.

For more information on target groups and to see the rationale behind the recommendations
please visit the ACIP website at: http://www.cdc.gov/vaccines/recs/provisional/default.htm.

Note: these target groups are somewhat different than those groups that are recommended
for seasonal influenza vaccine. For a chart comparing target groups for seasonal influenza
vaccine compared with target groups for novel H1N1 influenza monovalent vaccine please see
Appendix C.

   C. Verification of Priority Group Membership

Neither the CDC nor the NYSDOH will require that potential vaccine recipients verify that they
are members of a target group for novel H1N1 influenza monovalent vaccine. During screening,
potential vaccinees will need to be asked whether or not they are in target groups. However,
good judgment should be used and there is no need for proof such as laboratory tests, a doctor’s
note, or employment identification to be required.


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For more information on target groups and the novel H1N1 influenza vaccine, please see
Use of Influenza A (H1N1) 2009 Monovalent Vaccine, MMWR, August 28, 2009/Vol. 58
(No. RR-10) in Appendix D.


VI.     Logistics

The goal of logistics planning is to quickly deliver, in an orderly fashion, needed supplies and
vaccine to local agencies to allow them to immunize their communities. Distribution will utilize
a hybrid system based on the State’s Strategic National Stockpile (SNS) plan, centralized
distribution by the Federal government, and secondary distribution by the NYSDOH and LHDs.
The distribution of vaccine will involve numerous local, State, Federal, volunteer, and private
organizations.

   A. Vaccine Supply

Vaccine supply and availability is dependent on several factors including vaccine production
capacity, speed of regulatory review, results of clinical trials and demand. As of the date of this
plan, vaccine is expected to become available in mid October, 2009. Some doses may be
available in late September, 2009. The national supply is expected to be about 40 to 50 million
doses delivered in a bolus over 3-4 weeks, and then a supply of 20 million doses per week. The
NYSDOH expects losses of about 5% of the vaccine due to improper storage and handling,
consistent with losses that occur with other vaccines. This leaves New York State with about
1,300,000 doses from the bolus and about 650,000, doses weekly after that. Vaccine will be
supplied by the CDC in minimum shipments of 100 doses. Each 100 doses provided will be only
one type of vaccine from one manufacturer.

   B.    Methods of Distribution for the Novel H1N1 Influenza Monovalent Vaccine

Distribution of novel H1N1 influenza monovalent vaccine will use a hybrid system based on the
State’s SNS plan, centralized distribution by the Federal government, and secondary distribution
by the NYSDOH and LHDs. Vaccine distribution will occur under the control of the NYSDOH
for all counties outside of New York City. Vaccine will be distributed through a central
distributor that is under contract with the CDC. The NYSDOH will direct the central distributor,
McKesson Specialties, to deliver vaccine to sites in New York State. The maximum number of
sites available to New York State is 3,627. This will not be enough sites and secondary
distribution by the NYSDOH and LHDs will be required.

   C. How Private Providers, Pharmacists and Others Will Receive the Novel H1N1
      Influenza Monovalent Vaccine

Details about receiving vaccine are still being worked out. Vaccine distribution will be managed
by the NYSDOH with assistance from a variety of sources. Most providers and pharmacists will
be receiving novel H1N1 influenza monovalent vaccine directly through CDC’s central
distributor, McKesson Specialties. Providers and pharmacists may receive vaccine from their
LHD or from the NYSDOH. It is possible that some pharmaceutical distributors will also be


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used. A website will be available for providers and pharmacists to register interest in receiving
vaccine. It is not yet clear if all providers who express interest will be able to access vaccine

   D. Requirements for Receiving Vaccine

All health care providers who are interested in receiving novel H1N1 influenza monovalent
vaccine must pre-register with the New York State Department of Health (details below).

Pediatric health care providers who administer vaccine to persons less than 19 years of age
(i.e. pediatricians, etc.) must also establish a NYSDOH Health Commerce System account and
record vaccine doses in the New York State Immunization Information System (NYSIIS) as
required by State Law.

These steps can be completed by accessing this website:
https://hcsteamwork1.health.state.ny.us/pub

   •   Establish a NYSDOH Health Commerce System (HCS) account
           o The Health Commerce System (HCS) (also referred to as the Health Provider
              Network or the HPN) is a secure web-based system designed by the NYSDOH
              specifically for electronically exchanging health related data and information
              between health care providers and NYSDOH.
           o Note: this is the same account that physicians use to update their Physician
              Profile; all physicians should have an account.
           o Completing the on-line HCS application request form will bring the user to the
              vaccine pre-registration form and the HCS application information will pre-
              populate appropriate fields to expedite the vaccine pre-registration process.
   •   Pre-register interest in receiving H1N1 vaccine with the NYSDOH vaccine program
           o This pre-registration process is designed for you to express interest only and does
              not obligate you to receive/administer vaccine nor does it guarantee you will
              receive vaccine.
           o Once your registration is received and the remaining details of the vaccination
              campaign have been finalized, you will be contacted by the vaccine program to
              sign the formal provider agreement that has been supplied by the Federal
              government.
   •   Learn more about the New York State Immunization Information System (NYSIIS),
       also known as the immunization registry (see attached fact sheet).
           o NYSIIS participation is required by law for providers who immunize persons less
              than 19 years of age. Participating in training establishes a NYSIIS user account.
           o NYSIIS participation is strongly encouraged for providers administering novel
              influenza A (H1N1) monovalent vaccine. An online orientation and/or full
              training opportunities are available to assist new users.
           o 47 electronic health record/billing vendors are approved to automatically upload
              immunization information to NYSIIS, minimizing data entry requirements.

   •   See Appendix E for a the Pediatric Health Care Provider Letter and NYSIIS Fact Sheet;



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Adult health care providers who are interested in receiving novel H1N1 influenza monovalent
vaccine to administer to persons 19 years of age or older are strongly encouraged to complete the
3 steps, above, to be able to record H1N1 vaccine doses into NYSIIS. Entry of H1N1 vaccine
doses into NYSIIS is important to 1) generate federally mandated weekly vaccine usage reports,
2) monitor vaccine inventory to enable prompt reordering, 3) generate reminders for the second
influenza vaccine dose, if required, 4) provide a legal record of the vaccination, 5) enable correct
ascertainment of prior influenza vaccine history if patients receive some influenza vaccine doses
(seasonal and/or monovalent H1N1) at other provider sites, and 6) enable NYSDOH to closely
monitor possible vaccine adverse events.

Adult health care providers, who do not sign up for NYSIIS, must still pre-register interest in
receiving H1N1 vaccine with the NYSDOH vaccine program by going to the website above. In
addition, adult providers that do not use NYSIIS to record the individual doses given must report
the aggregate number of doses administered by age group to the NYSDOH using a system that
will be set up shortly. This is to meet weekly, federally mandated reporting requirements, a
condition of receiving the 2009 novel influenza A (H1N1) monovalent vaccine.

   •   See Appendix E for a the Adult Health Care Provider Letter;

LHDs do not have to register with the NYSDOH to receive vaccine.


   E. How Health Care Facilities Will Be Able to Access Novel H1N1 Influenza
      Monovalent Vaccine

All health care personnel and emergency medical service providers are within the initial target
groups for vaccination with the novel H1N1 influenza monovalent vaccine. All hospitals,
nursing homes, and community health centers (CHCs) will receive an allocation of the vaccine
for use in the facility either directly from McKesson Specialties or NYSDOH. Other health care
facilities will also be able to receive vaccine and should follow the procedures outlined above
and make sure they have the required accounts set up.


VII. Allocation and Dispensing
   A. Allocation

Vaccine will be allocated to each state based on its population. In New York State outside of
New York City, the vaccine will then be allocated to each hospital based on the size of its staff
and bed number. Vaccine will then be allocated to each LHD based on the size of the population
within the county, whether there are colleges or universities located in the county and the
presence of other health care facilities such as nursing homes.

The NYSDOH has quantified each target group for the State and for each county. Although
these numbers are estimates, there will be enough vaccine from the initial bolus and the weekly
amounts to vaccinate all target groups in eight weeks with one dose of the vaccine. This model
assumes 100% uptake of the vaccine which is very unlikely to occur. An assessment will be

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made around the eight week mark whether it is possible to expand vaccination to the next ACIP-
recommended groups (healthy adults 25-64 years of age).

The NYSDOH will work with each county health department to determine where and how
vaccine should be allocated within the county. Since a minimum order of 100 doses is required
by CDC, LHDs will have to assist in getting vaccine to small providers, colleges, and pharmacies
where an order of 100 doses cannot be used.

   B. Dispensing Vaccine

Vaccine will be administered in a variety of settings that correspond with the ability to reach the
primary target groups. The vaccination campaign will require an unprecedented degree of
partnership between the public and the private sectors to deliver novel H1N1 influenza
monovalent vaccine. Guidelines for mass clinic planning can be found in Appendix F.

The following settings are being considered as sites for vaccine administration:
   • LHD clinics
   • Schools
   • Provider offices (primary care, Peds, OB/GYN, Family Medicine, Internal Medicine)
   • Community health centers
   • Colleges and universities
   • Pharmacies
   • Health care facilities (hospitals, outpatient settings, etc.)
   • Occupational settings
   • Through mass or community vaccinators

A great deal of work has been done in regard to planning for large-scale distribution of
medications and vaccines in the context of planning for a bioterrorist event using the Point of
Dispensing (POD) model. Pandemic administration plans will use what has been planned and
learned from the POD model, however, PODS may not always be appropriate for this
vaccination campaign and other types of clinics may be used.

   C. Sites for Vaccine Administration

The appropriate combination of sites within a county will depend on several factors including the
size of the population, the number of health care facilities that are within a county, the presence
of colleges and universities and the geographic features and barriers present. Sites that can be
considered for planning purposes are described below. It is anticipated that most or all of these
kinds of sites will be used for vaccine administration in each county. For every location or site
where vaccine is provided, a provider agreement provided by the Federal government will need
to be put in place that guarantee that vaccine will be used according to federal and state
guidelines, stored appropriately, kept securely and that usage will be tracked and recorded. An
appropriate individual will be designated at each site to receive and monitor use of vaccine
supply.




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           • LHDs
       The NYSDOH and other New York State agencies have been working with LHDs to
       develop the capability for mass distribution of medications and vaccines. In New York
       State, LHDs are the primary sources of public health services and have established
       relationships with partners and sites within their communities to conduct dispensing
       activities. The LHDs have established Memorandums of Agreement (MOAs) with sites
       and points of contact within their counties and have addressed staffing requirements and
       the ability to administer medications or vaccines within set amounts of time. All of the
       57 LHDs in the State (excluding New York City) have conducted exercises to test their
       capabilities and to identify gaps and strengths. Many have used the lessons learned to
       address real emergencies that have required mass distribution of vaccine or medication.
       LHDs may not be the primary site of vaccination in their county but will work to assure
       that all residents have access to vaccine. Depending on the mix of vaccine delivery sites
       in the county, it is expected that all LHDs will need to run some points-of-dispensing
       mass clinics to fill gaps and address the needs of special populations, such as persons
       without health insurance and possibly pregnant women.

           • Schools
       The need to immunize a large number of children in a short period of time has prompted
       consideration for the use of school-based vaccination clinics. Vaccinating in schools
       poses significant challenges that include obtaining consent from parents or guardians, the
       need to bring vaccinators into school, the difficulties of vaccinating very young children,
       the inability to easily bill insurance and other factors. The NYSDOH will work with
       LHDs and mass and community vaccinators to hold vaccination clinics in schools. It is
       expected that school vaccination clinics will be held under the general direction of the
       LHD.

           • Provider Offices
       Patients who are targeted to receive vaccine may be able to receive immunizations at
       their own medical provider site (Pediatricians, Family Physicians, Internist and medical
       specialists, and obstetricians).

       The NYSDOH has an existing relationship with most pediatricians and family physicians
       in New York State through the New York Vaccines for Children (NYVFC) and Child
       Health Plus (CHP) Programs. The existing infrastructure through which these vaccines
       are ordered by and delivered to participating physicians’ practices could be used to
       deliver novel H1N1 influenza monovalent vaccine. The centralized distribution network
       that serves these programs is centered on a vendor under contract with the Federal
       Government, McKesson Specialties, which has warehousing and distribution facilities in
       Memphis, Tennessee and Sacramento, California.

       Most pediatricians and family physicians in New York State participate in either the VFC
       or CHP program and the necessary information on their location, ship to site, hours of
       operation, etc. are known. In addition these providers have a demonstrated capacity to
       safely and effectively store refrigerated vaccines. Most of these physicians’ practices are
       also reporting to NYSIIS. NYSIIS will be required for providers, in New York State
       outside of New York City, administering novel H1N1 monovalent vaccine to persons less
       than 19 years of age.
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           • Internists and OB/GYNs
       Other target groups identified by the CDC having a high priority for novel H1N1
       influenza vaccination include adults under age 65 with certain underlying health
       problems and pregnant women. Internists and OB/GYNs will play an important role in
       reaching these individuals. Unlike pediatricians and family physicians, these providers
       largely do not have an existing relationship with the vaccine distribution system that
       supports the VFC and CHP programs. If vaccine were to be distributed to physicians in
       these specialties, steps will need to be taken to identify them, ensure that they have the
       capability and knowledge to safely store and handle vaccine, collect shipping and hours
       of operation information, and enroll them in a system to capture information on novel
       H1N1 influenza monovalent vaccinations. NYSIIS participation is required by law for
       providers who immunize children and strongly encouraged for providers who care for
       adults. More than 47 electronic health record/billing vendors are approved to
       automatically upload this information to NYSIIS. Outreach to providers interested in
       participating in NYSIIS can be accomplished through cooperation with professional
       societies including the Medical Society of the State of New York and the American
       College of Obstetricians and Gynecologists. Direct communications can also be made
       through the Health Provider Network. A letter to these providers inviting participation in
       the vaccination campaign will be sent in early September, 2009.

       New York State may ask LHDs to reach out to large medical practices that serve adults,
       including OB/GYNs, to establish a link with them and to guide them in enrolling in the
       novel H1N1 influenza vaccination effort. These providers will have to make themselves
       known to the NYSDOH so that the vaccine preregistration website (see Appendix E). If
       an insufficient number of individual providers can be accommodated by the centralized
       distribution system, some of these providers may have to receive their vaccine through
       the auspices of the LHD.

           • Community Health Centers
       There are approximately 19 Federally Qualified Community Health Centers (FQHCs) in
       New York State outside New York City. These 19 FQHCs are supplemented with about
       100 satellite clinics, a number of which are school based. These clinics are typically
       located in medically underserved areas or serve low income populations that typically
       have inadequate or no health insurance. Vaccinations are routinely given to both children
       and adults at FQHCs. FQHCs also participate in the VFC and CHP programs and are
       therefore a part of the existing vaccine distribution infrastructure managed by the Bureau
       of Immunization. FQHCs could play a role in vaccinating individuals for novel H1N1
       influenza who would otherwise not be served by an LHD or a private physicians practice.
       FQHCs could be enlisted in the vaccination campaign relatively easily, through direct
       contact on a one on one basis or through the Health Commerce System.

           • Colleges and Universities
       There are 283 colleges and universities in New York State, 182 of which are located
       outside of New York City. Individuals aged 18-24 years are a CDC identified target
       group for vaccination against novel H1N1 influenza. As most colleges and universities
       have some health care capability aimed at serving their student population, these entities
       would potentially be significant vaccinators for this age group. As the number of
       campuses is relatively small, it would be possible to enroll them in the necessary
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       logistical and reporting mechanisms in order to provide them with vaccines and to collect
       information on vaccinations given. Liaison work to include colleges and universities
       could be carried out through contacts with the New York State Dept. of Education and
       the New York State College Health Association.

           • Pharmacies
       In New York State, pharmacists who are trained and certified by the New York State
       Board of Pharmacists, can immunize adults aged 18 years of age and older with influenza
       and pneumococcal vaccine. Partnering with pharmacists will significantly reduce the
       burden of vaccination on LHDs. Because many of the adults who have chronic diseases
       enter pharmacies to obtain prescription medications and pharmacies are often located in
       retail centers, pharmacies are a practical site for immunization administration. The
       ability of pharmacists to provide immunizations to this population will be invaluable in
       helping adults overcome barriers to access to vaccines.

           • Health Care Facilities
       Hospitals and long-term care facilities would be logical sites for the administration of
       vaccine. Health care facilities (HCFs) have the staff with appropriate vaccination skills
       and are also sites where those prioritized for vaccination, such as health care workers,
       individuals with chronic conditions, and pregnant women are seen, work or visit.

           • Occupational Clinics
       Occupational health clinics exist to serve health care workers in hospitals and other
       health care facilities as well as employees of various private corporations and institutions.
       Hospitals and other venues where health care workers could be vaccinated by their own
       employers should be given vaccine, whether through a CDC managed centralized
       distribution scheme or through the aegis of the NYSDOH, in amounts adequate to
       immunize staff with patient contact. Data on the number and location of these health care
       workers should be currently available so that the requisite amount of vaccine can be
       identified. Locations and ship to points should also be available. To the extent that these
       entities serve individuals who are in CDC target groups they could potentially be
       recruited to vaccinate if they could be identified and enlisted to participate in the existing
       vaccine distribution and tracking mechanism managed by the Bureau of Immunization.
       Depending on the number of these entities and their location they may be able to play a
       role provided the logistical hurdles can be cleared.

           • Mass or Community Vaccinators
       Mass vaccinators, which in New York State is largely restricted to licensed home care
       agencies (LHCAs), may have a role to play in providing licensed vaccinators to assist in
       community vaccination efforts. A number of LHCAs have indicated, by responding to a
       recent Request for Information (RFI) distributed by the NYSDOH that they would be
       available to provide community vaccination services in certain areas. Almost all LHCAs
       are limited in the geographic areas in which they are equipped to function. Some are
       limited to only one county in the State. One large national mass vaccinator, Maxim
       Health Services, is theoretically able to provide services anywhere in New York State.
       Maxim typically hires several thousand nurses to provide vaccination services through
       private corporations such as pharmacy and supermarket chains for annual seasonal
       influenza vaccination campaigns. Maxim also works with certain LHDs in New York
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        State to assist in their influenza vaccination efforts. Other LHCAs may fulfill a similar
        role in limited areas.

        Contracts are under development between Health Research, Inc. (HRI) and mass
        vaccinators. These entities could then be directed to collaborate with LHDs in assisting
        in community vaccination campaigns. LHDs would probably be required to identify sites
        where clinics that were staffed by private mass vaccinators could be held. Alternatively
        staff provided by mass vaccinators under contract with HRI could work with LHDs at
        existing clinic sites.

        Information collected through the RFI is being collated and analyzed, so that the resultant
        staffing resources could be allocated based on need and geographic availability.
        Information garnered from mass vaccinators operating within the five boroughs of New
        York City will be shared with the NYCDOHMH. A draft agreement that could be signed
        by mass vaccinators and the HRI is being finalized (Appendix J).


   D. Cost Coverage for Administration of the Novel H1N1 Influenza Monovalent
      Vaccine

The novel H1N1 influenza monovalent vaccine itself and supplies to administer it will be
provided without charge by the Federal government. It is expected that the administration fee for
vaccination in private medical settings will be covered by most health insurance, Medicaid and
Medicare. For those who do not have insurance or whose insurance will not cover the
administration fee, a fee can be charged or, if a patient cannot afford the fee, he or she can be
vaccinated by private providers who are willing to waive the fee, or by the LHD. LHDs have the
responsibility of assuring that those without insurance coverage are able to be vaccinated in their
county. Since there are so many individuals that need to be vaccinated, all types of vaccinators
will need to be flexible when encountering those who are uninsured or cannot afford the
administration fee.

Vaccination will most likely occur in schools across the state. Cost coverage in schools is a bit
more complicated and can be handled in a variety of ways. Guidance on how to conduct
vaccination clinics in schools will be forthcoming from both the CDC and the NYSDOH.

VIII.     Vaccine Monitoring

Vaccine safety monitoring during a pandemic is critical to assess the occurrence of adverse
events and provide data regarding any risks of vaccination. Influenza vaccine, like all vaccines,
occasionally causes local reactions at the site of injection and may cause mild systemic
symptoms such as headache or fever. More severe systemic reactions generally are extremely
rare. The safety profile of the novel H1N1 influenza monovalent vaccine is not expected to be
different than that usually seen with the annual influenza vaccine.

    A. Vaccine Efficacy
The benefit of vaccination is measured by determining vaccine efficacy. During a pandemic the
determination of vaccine efficacy would most likely be the role of CDC. However, the

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NYSDOH may be asked or required to participate in efficacy studies. As resources permit,
NYSDOH may to conduct efficacy studies in the early stages of the pandemic when fewer
individuals are being vaccinated and active surveillance is more practical. It is possible that
accurate and complete efficacy data may not be available until the later stages of the pandemic,
depending on how much notice CDC and manufacturers have to develop a novel vaccine.

   B. Contraindications

There are currently very few contraindications to vaccination against influenza. Vaccine should
not be administered to persons with known anaphylactic hypersensitivity to eggs or other vaccine
components as described in the package inserts.

In the setting of a pandemic, desensitization may be an option for those with a history of
anaphylaxis to egg products and with high risk for influenza or its complications. An alternative
for prevention would be prophylaxis with an antiviral medication.

Since the technology and methods used to manufacture the novel H1N1 influenza monovalent
vaccine are the same as those used for seasonal influenza vaccine, the same contraindications
would exist. Providers are comfortable and familiar with these restrictions on the use of
influenza vaccine. Efforts must be made to educate all health care providers, vaccine
administrators, and vaccine recipients on the potential risks of the novel H1N1 influenza
monovalent vaccine if any become known.

   C. Vaccine Adverse Event Monitoring and Reporting

In the U.S., national surveillance for adverse events following immunization is routinely
conducted through the Vaccine Adverse Event Reporting System (VAERS), which is managed
jointly by the CDC and Food and Drug Administration (FDA). Events that may be associated
with vaccination can be reported on paper forms, by telephone, or electronically by health care
providers, patients, health departments, or vaccine manufacturers. Reports of serious adverse
events are followed up to collect additional information for analysis to determine whether such
events are reported more frequently than expected.

During a pandemic, VAERS would remain the major reporting mechanism. The NYSDOH has
identified a vaccine safety coordinator as well as a back-up vaccine safety coordinator to oversee
reporting policies, methodologies and procedures as well as to ensure that adverse events are
reported to VAERS and followed up appropriately. CDC has stated that adverse events reported
to VAERS will be supplied to the NYSDOH on a weekly basis.

During a pandemic, vaccine recipients with concerns about a potential adverse event will be
referred to their own health care provider or the local emergency department for medical
evaluation. If a provider requires medical advice or support, he or she may call the medical
director of their LHD or their designated medical Regional Resource Center (RRC). There are 8
RRCs throughout the upstate area. Theses are medical centers with a complete selection of
medical specialists that can care for and address adverse events. Physicians at the NYSDOH will
be available for consultation on vaccine related adverse events, and can consult experts at the
CDC if required.

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It is likely that VAERS will be supplemented by additional surveillance and studies to rapidly
evaluate the safety of the vaccination program. Existing databases will be analyzed to compare
rates of medical visits and hospitalizations for persons who are vaccinated with those who are
not. Databases also can be analyzed to compare rates of illness and medical care shortly after
vaccination with other time periods. Large scale safety studies are best conducted by national
organizations, and once a campaign to vaccinate large numbers of individuals is underway,
active surveillance will be impractical. Active surveillance for Guillain Barre Syndrome will take
place by conducting outreach to all neurologists in New York State.

IX.    Clinical Management

The Novel H1N1 Influenza Mass Vaccination Campaign will require that immunization takes
place in a variety of different types of sites. However, each location will have to carry out similar
and basic functions: to screen individuals for contraindications to vaccination, educate potential
recipients about the vaccine, administer the vaccine and track all doses given. The basic elements
of planning for large scale clinics are contained in the Appendix F and the NYSDOH Point of
Dispensing Standard Operating Guide.

   A. Planning Considerations for Large-Scale Vaccination Clinics

Listed here are the major elements needed for mass clinic planning:
    • Command and control;
    • Staffing roles required, and job descriptions;
    • Clinic supplies;
    • Procedures for requesting vaccine or medication;
    • Vaccination clinic location;
    • Clinic lay-out and specifications;
    • Crowd management outside of the clinic;
    • Crowd management inside of the clinic;
    • Clinic security;
    • Clinic advertising;
    • Risk communications/health education;
    • Adverse event tracking;
    • Data management; and
    • Information on special needs populations.

Influenza specific materials include:
    • Target groups for vaccination;
    • Composition of the current vaccine;
    • Standing orders for administering influenza vaccine;
    • Information on live attenuated influenza vaccine (LAIV);
    • General influenza vaccine information;
    • Information on how to administer influenza vaccine;
    • Sample forms to screen for contraindications;
    • Facts sheets from the CDC;


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   •    Vaccine information sheets (VISs) on novel H1N1 influenza /seasonal influenza vaccine
        in appropriate languages;
   •    Information on respiratory hygiene in healthcare settings;
   •    Patient education materials; and
   •    Information on H1N1 influenza.

   B.    Handling & Storage (Cold Chain)

It is important to keep vaccines at the specified temperature at all times starting from the
manufacturer until the vaccine is used. It is important to keep vaccines from freezing and/or
getting warmer than the temperatures specified for proper storage. Problems that may occur with
the “cold chain” of vaccine include storage unit malfunctions, power outages, or staff errors.
During an influenza pandemic, it will be necessary to exert vigilance in maintaining the cold
chain as vaccine supply may be scarce and not be able to be replaced. Therefore, it will be
essential to have the appropriate equipment, train staff and develop standard operating
procedures outlining protocols to protect the vaccine “cold chain.”

Handling Vaccine:
   • Maintain a daily temperature log; check unit temperature two times per day.
   • Open and store vaccine shipments immediately upon arrival.
   • Monitor inventory daily in the initial phases of vaccination, less frequently when supply
       increases.
   • Rotate vaccine according to expiration dates; those with shortest expiration dates should
       be used first.
   • Securely close refrigerator and freezer doors.
   • Lock refrigerator and freezer doors at the end of each day.
   • Provide personnel in charge of vaccine with 24-hour access to building and storage
       location; develop standard procedures on how to notify individuals if there is a power
       outage or problem in the vaccine storage location.
   • Identify a maintenance repair company in the event that the unit breaks down.
   • Provide security to assure the safety of scare vaccine supplies through existing security
       plans.

Storing Vaccine:
   • Vaccine should be stored in a refrigerator/freezer unit. It should not be a refrigerator unit
       that uses a freezer tray, such as a dormitory style unit, because this type of refrigerator is
       not able to maintain adequate temperatures.
   • The unit should be capable of maintaining a temperature between 35-46 degrees F (2-8
       deg C) in the refrigerator section and 5 degrees F (-15 deg C) in the freezer.
   • Place a warning at the plug and the associated circuit breaker to ensure neither has power
       removed without first informing appropriate personnel.
   • A thermometer should be located in both the refrigerator and the freezer section.
   • An alarm system should be integral to monitor for both temperature and possible
       tampering.
   • The doors of the storage units or the storage location should be secured with a locking
       mechanism.

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   •   The unit should have a back-up generator power in case of an outage.
   •   Vaccine should be stored in the center of the unit, never in the doors.
   •   Food or beverages should never be kept in the same unit as vaccine.
   •   Avoid opening and closing the unit as much as possible in order to maintain a constant
       temperature.
   •   Storing bottled water and gel packs in the doors may help in regulating the space
       temperature and maintaining the temperature during a short power outage.
   •   Train employees on correct storage of vaccine, acceptable temperature ranges and
       emergency procedures.
   •   A specific written plan should be available in the case of a power outage.
   •   There should be a plan for an alternate storage location in the event that the vaccine needs
       to be moved in an emergency (Hospital, Fire Department, etc.).

   C. Transporting Vaccine

In order to transport vaccine appropriately, it is imperative that the following shipping materials have been
purchased: insulated Styrofoam containers, ice packs, temperature monitors, and sheets of bubble or foam wrap.
Procedures for proper transport include the need to:
    • Place ice packs on the bottom of the Styrofoam container.
    • Place bubble wrap or foam wrap on top of ice packs. (Vaccine should not come in direct
       contact with ice packs).
    • Place vaccine in the container.
    • Insert temperature monitors near the center of the vaccine.
    • Place more bubble wrap or foam wrap on top of vaccine.
    • Place more ice packs on top of bubble wrap.
    • Ensure vaccine is secure in the container and close and seal the lid.
    • Clearly label the container “Vaccine- Refrigerate Immediately” and deliver vaccine to
       destination without delay.
    • Ship using Priority, Overnight Mail on Monday, Tuesday or Wednesday to ensure the
       product arrives before the weekend. Some shippers require the Styrofoam container to be
       inside an additional cardboard box for shipping

   D. Equipment Malfunction

If equipment breaks down or the storage location becomes inadequate due to an emergency:
    • Move the vaccine to an alternate refrigerator.
    • Move the vaccine to an alternate storage location.
    • If vaccine reaches temperatures outside of the recommended range, immediately store it
        in a location at the appropriate temperature and clearly mark and separate it from other
        vaccines so that it may be checked later. Don’t assume that it is spoiled; depending on the
        recommendations of the manufacturer the vaccine may still be viable.
    • Contact the manufacturer for guidance regarding the status of the vaccine.
    • Do not discard spoiled or expired vaccine. Contact the NYSDOH and return vaccine
        accordingly.



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   E. Administering a Second Dose of Vaccine

Annually administered influenza vaccine requires that a second dose of vaccine be administered
to those individuals under the age of 9 years who have never received influenza vaccine before.
Since most of the population is immunologically naïve to the novel H1N1 influenza viral strain,
it is likely that 2 doses will be needed for individuals of all ages to mount an adequate immune
response.

Federal planning guidance has clearly stated that vaccine should not be held to administer a
second dose but should continue to be given to those who are seeking vaccination.

Persons receiving their first does will need to receive information about returning for the
additional dose. Vaccine providers will need to record the doses given and document when an
individual has received the 2 doses. As the program progresses, information on return rates will
be available and it may be possible to plan for the administration of a second dose. NYSIIS can
be used to track all doses administered during the campaign, and is required for pediatric
immunizations. NYSIIS also has the capability of generating a report of those persons needing a
second shot, along with recall and reminder letters.


   F. Contingency Planning For Use of Emergency Use Authorization

If any novel H1N1 influenza monovalent vaccine is released that contains an adjuvant, it may be
necessary to distribute unlicensed vaccine during a pandemic. Unlicensed vaccine may be
needed, for example, if pandemic spread is rapid and there is insufficient time to conduct
standard vaccine efficacy studies of the adjvanted vaccine.

There are two mechanisms for use of unapproved medical products or unapproved uses of
approved products. The first is under the FDA’s Investigational New Drug (IND) provisions.
IND provisions require completion of a signed consent form from each person who receives the
medication and mandatory reporting of specified types of adverse events. IND provisions also
require strict inventory control and record-keeping, and approval from Institutional Review
Boards (IRBs) in hospitals, health departments, and other venues. The FDA regulations permit
use of a national or “central” IRB. The NYSDOH has staffing capabilities and printing facilities
to coordinate the receipt, mass production and distribution of the IND protocols and consent
forms. However, it is anticipated that IND requirements will be too difficult to meet during a
widespread emergency such as a pandemic.

As an alternative to IND use, HHS may utilize the drug product under EUA procedures. If a
national emergency is declared by the Secretary of the HHS and the FDA Commissioner may
authorize the use of an unapproved medical product or an unapproved use of a licensed medical
product. Once issued, an EUA is active for one year but may be terminated earlier if the HHS
Secretary determines that it is no longer needed. EUA procedures are described in the FDA draft
guidance “Emergency Use Authorization of Medical Products” available on the FDA website at
www.fda.gov/cber/gdlns/emeruse.pdf.



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EUA requirements include record keeping, distribution of information sheets to providers and
patients, and adverse event reporting. CDC operational plan for EUAs is development.

   G. Clinical Communication

Timely, clear, consistent and effective messaging is essential to ensure that members of the
public understand limitations on vaccine availability and efficacy and are willing to engage in
other critical risk reduction measures (pharmaceutical or non-pharmaceutical interventions) in
the event that sufficient supplies of vaccine are not available for all ill persons. It is also
important that medical providers of vaccination services have the necessary information to
conduct vaccination activities safely and effectively. While the majority of medical providers
who are eligible to become novel H1N1 influenza monovalent vaccinators have training
regarding immunization practices, many, especially adult providers, will not have experience
handling, storing, and using large amounts of vaccine nor working with public health. It is
equally important that messages relating to vaccine availability, efficacy and prioritization are
crafted to help address the problem of worried individuals over- burdening healthcare resources.
To accomplish these goals the NYSDOH will:
    • Provide pre-event education to various sectors using mass media, public engagement and
        targeted communications;
    • Prepare and disseminate information for health care providers;
    • Prepare public information materials pre-event and provide them to public website staff
        for posting on the Department’s “test” website;
    • Provide script templates and pre-recorded messages to the Department’s contract call
        center operators, and also disseminate these materials to key communications partners;
    • Provide information for internal audiences (e.g., NYSDOH/Health Research, Inc
        employees); and
    • Use materials provided by the Federal government and adapt for use in New York State.

Materials and messages will need to be developed that reach a broad spectrum of the public.
This may mean dissemination in a variety of languages and reading levels and the use of
methods to reach those not ordinarily accessible by mainstream methods.

   H. Workforce

Staffing is an important component of conducting any type of long-term dispensing system and
can be estimated once the number of sites required is identified and the hours during which they
will operate are established.

Hospitals, Medical Reserve Corps (MRCs) and LHDs should be working together to identify and
recruit medical and non-medical volunteers who can assist in healthcare settings or in PODs.
These volunteers should be included in local emergency efforts when exercising hospital-PODs
and LHD PODs. In the aftermath of September 11th, the NYSDOH developed a statewide
Health Emergency Preparedness Volunteer Practitioner Database (ServNY) of licensed
professionals who would be willing to volunteer their services in the event of a public health
emergency. The purpose of this ServNY is to assure that New York State has adequate resources
to prepare for and respond to any public health emergency when their local volunteer resources
are depleted. The database is designed not to deter or compete with volunteer recruitment efforts

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on the local level, but rather to supplement and serve as a logical extension of those efforts.
Volunteers who participate in this state-sponsored volunteer program are provided liability
protection of Public Officers Law § 17 if they are activated and deployed by New York State.

See also section XI Guidance for Local Health Departments on the Novel H1N1Influenza Mass
Vaccination Campaign

In the event the Governor declares a state emergency he may choose to suspend laws that
currently prohibit other licensed health care professionals from administering vaccinations.

     I.   Training

The NYSDOH has been conducting training in roles associated with mass vaccination since
2003. In 2004, training was expanded to include roles associated with both mass vaccination
clinics and mass prophylaxis clinics, with emphasis on transferability of skills across clinic type.
In 2006, training was modified again to include pediatric clinics, as well as roles associated with
push methodologies for vaccination or prophylaxis. Job action sheets have been created for all
clinic roles, and a just-in-time training guide has been integrated into the NYSDOH POD
Standard Operating Guide. Training has also been provided to state and local public health
providers in the “Clinic Planning Model Generator,” to assist in identification of numbers of staff
needed for clinics based on type of clinic, population, and other factors associated with mass
clinics.

Training will continue via multiple methodologies (didactic, webinar, videoconference, online
training) not only for roles associated with mass clinics, but also for roles associated with the
Strategic National Stockpile (SNS) (Job action sheets have been developed for each of these
roles).

Additionally, volunteers have been integrated into mass clinic exercises via agreements with
local MRCs. Just-in-time training has been provided in clinic roles at both state operated mass
influenza vaccination clinics, as well as such clinics at the local level. Mass clinic exercises with
associated training will continue on a yearly basis. These activities are ongoing for both short-
term and long-term operation of the pandemic influenza plan.

X.        Information Technology in Support of Vaccine Distribution

The capability to gather essential information regarding the acquisition, allocation, distribution
and use of pandemic vaccine will be a critical aspect of the response to a pandemic. The goal is
to track inventory, record the number of doses given and to whom they were given, monitor
adverse events, and fulfill federal reporting requirements. An integrated system using pre-
existing electronic applications that have already been developed would meet the data needs of a
pandemic response. To ensure optimal use of a new pandemic influenza vaccine, data will need
to be collected on vaccine effectiveness, vaccine supply and distribution, vaccine coverage and
vaccine safety.

NYSIIS is the confidential and secure web-based system that collects and stores a record of
immunizations given to individuals of all ages. It is required by Public Health Law 2168 that all

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immunizations given to children less than 19 years of age be entered into NYSIIS. New York
State Department of Health is working to eliminate the requirement for separate written consent
for individuals 19 years of age and older.

All novel H1N1 influenza monovalent vaccines given must be entered into NYSIIS for pediatric
immunizations and is strongly encouraged for adult vaccine providers. All providers,
pharmacists and health care facilities who wish to give the novel H1N1 influenza monovalent
vaccine must preregister their interest in receiving vaccine with the NYSDOH Vaccine Program,
the NYSDOH Health Commerce System (HCS) and NYSIIS.

LHDs will have the option of entering vaccination information directly into NYSIIS or using the
Clinical Data Management System (CDMS). The NYSDOH is working to create an electronic
system that will transfer information from CDMS to NYSIIS.

   A. Objectives:

   •   Enhance and maintain the NYSIIS as the primary and preferred web-based data
       collection tool to support patient level data collection.
   •   Enhance and maintain the CDMS as an alternative electronic and paper-based data
       collection tool to support patient level data collection for LHDs only.
   •   Develop a data linkage to feed CDMS data into NYSIIS as the central repository for
       information on novel H1N1 influenza monovalent vaccine doses administered.
   •   Develop a streamlined electronic registration process to support the recruitment of
       organizations interested in receiving novel H1N1 influenza monovalent vaccine.
   •   Support the accessibility of the NYSIIS database for data analysis.
   •   Assist vaccination sites with tracking vaccine inventory once shipment received from
       distribution channels.
   •   Enhance ability to identify patterns in adverse events as a result of novel H1N1 influenza
       monovalent vaccination.

XI.    Guidance for Local Health Departments on the Novel H1N1Influenza
        Mass Vaccination Campaign

LHDs form the core of the Novel H1N1 Influenza Mass Vaccination Campaign. The Federal
government is supplying the vaccine and ancillary supplies at no cost, the NYSDOH is directing
the distribution of the vaccine and providing support and guidance, but it is the LHDs that are
responsible for managing the campaign on the local level. LHDs will be coordinating
vaccination activities within each county and also will assure that residents of each county have
access to vaccine. With careful planning most persons should be able to access their vaccine
outside of the LHD. However, in certain counties there may be a need for vaccination in the
public sector. It seems prudent for LHDs to plan to conduct mass public clinics (points-of-
dispensing) in the likely event that they need to provide vaccine to vulnerable groups such
pregnant women and the uninsured. The NYSDOH continues to investigate ways to support
local vaccination efforts with funds, staff, and supplies.

   A. Logistics


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Vaccine will be sent by the Federal government using the same central distributor, McKesson
Specialties that is used to distribute Vaccines for Children Program (VFC) vaccines. The
NYSDOH will direct McKesson to distribute the vaccine to all of the shipping sites that the State
(outside of New York City) is allotted (3627). The NYSDOH will direct vaccine to each of the
57 counties, medical providers, pharmacy chains, hospitals, and the State vaccine depot. LHDs
will be responsible for distributing vaccine to tribal sites, colleges and universities, schools,
small pharmacies, other health care facilities, small provider and others. If a LHD wished to
receive all of its county’s allocation and distribute it themselves, they are able to do so.

NYSDOH will:
  • Set up regional vaccination teams consisting of two positions in each regional office to
    assist in managing vaccine orders and clinics.
  • Set up an electronic ordering site so that all types of providers and facilities can register
    interest in receiving novel H1N1 influenza monovalent vaccine.
  • Provide each county with the sites that have registered and how much vaccine each has
    requested.
  • Work with each country to coordinate vaccine availability and the allocation of vaccine
    to sites within each county.
  • Provide materials to assist all types of vaccine providers on how to order vaccine,
    handling and storage, their role, and financial issues.

LHDs will:
  • Set up policies and procedures regarding the handling and transport of vaccine and
     supplies.
  • Create a process to make requests for additional vaccine or supplies.
  • Work with all medical providers in their county to ensure proper handling and storage of
     vaccine.
  • Communicate with all types of medical providers in the county about the vaccination
     campaign and their role.

   B. Allocation and Dispensing

Vaccine and supplies will be allocated separately to hospitals and LHDs. Hospital allocation
will be based on staff size and bed census. Allocation to LHDs will be based on population size.
Vaccine that is shipped directly to medical providers will be considered part of the pro rata
allocation the county in which the practice is located. NYSDOH will keep 2% of the vaccine to
vaccinate workers in State agencies, certain Federal agencies in New York State and others. A
predicted loss of 5% due to mishandling is being factored into the distribution allocation.

Vaccine will be administered in a variety of settings including LHDs, provider offices,
pharmacies, colleges and universities, occupational settings, health care facilities and others.
Each entity that orders vaccines, including LHDs, must have a licensed physician, nurse
practitioner, or physician’s assistant who will take responsibility for the vaccine and supplies.
Each licensed individual must also sign a provider agreement supplied by the Federal
government with some additions from the NYSDOH. LHDs can use the POD model to set up
mass clinics or create different sorts of dispensing scenarios


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NYSDOH will:
  • Work with LHDs on allocation amounts.
  • Provide each LHD with an estimate of the numbers of persons in each target group within
    their county.
  • Engage in contracts with mass and community vaccinators on behalf of LHDs so that
    these entities can be used to staff clinics in each county.
  • Provide contracts for medical and non-medical temporary workers to help staff
    vaccination clinics.
  • Provide financial assistance to LHDs to fund vaccination efforts.
  • Furnish the provider agreement.
  • Provide written materials on vaccination for providers that don’t usually vaccinate or are
    not VFC providers. The NYSDOH is creating a provider toolkit for this purpose.
  • Provide a toolkit to assist with vaccination in schools. See Appendix G
  • Provide training opportunities for providers on novel H1N1 monovalent influenza
    vaccine.
  • Provide information on liability and the Prep Act for providers.

LHDs will:
  • Plan to administer vaccine early in the campaign and later on as needed.
  • Plan for administration of vaccine without billing for or charging an administration fee.
  • Work to set up clinics in schools, either with vaccination by the LHD, using mass or
     community vaccinators, or both.
  • Encourage providers in the community to become novel H1N1 influenza vaccinators.
  • Work with pharmacists so that they can provide vaccines in the community.
  • Work with colleges and universities to encourage them to become vaccinators.
  • Work with all health care facilities other than hospitals so that they can receive vaccine.

   C. Workforce

“Options for Utilizing Students and Medical Residents,” this guidance is designed to provide
LHDs with options for supplementing their workforce during novel H1N1 influenza vaccination
by the use of students and medical residents. These students and residents could become a
significant component of vaccination efforts since LHDs may not be able to optimally staff
clinics to vaccinate CDC designated priority groups within a reasonable amount of time. In an
effort to vaccinate as many persons in the priority groups as possible, it is vital that we use all
personnel in the health care workforce in New York State.

Providers and planners of mass vaccination clinics established for the purpose of administering
novel H1N1 influenza monovalent vaccine receive broad federal Public Readiness and
Emergency Preparedness ("PREP") Act liability protection for activities related to the
distribution, administration, etc., of novel H1N1 influenza monovalent vaccine as long as those
providers are acting within the law of the state at the time and are part of the state or local
emergency response plan. LHDs should consult with their county attorneys for assistance in
adding emergency response plan provisions that address the use of non LHD personnel and sites,
in order to avoid claims that use of non LHD personnel are not part of their emergency response
plan.

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   D. Medical Students, Physician Assistant Students, and Medical Residents

Students and residents could be enlisted in a vaccination campaign if medical schools and
residency programs are willing to identify potential workforce participants on behalf of LHDs.
Currently there are:
    • Over 20 Physician Assistant Schools in New York State;
    • Approximately 12 registered medical schools, including both allopathic and osteopathic,
       in New York State and as such over 400 active medical students per school at different
       points in their training; and
    • Over 45 residency programs and over 15,000 medical residents in teaching hospitals
       across New York State.

Considerations
   • Medical students and residents need to be under the supervision of an authorized
      practitioner, i.e., RN or physician faculty.
   • Students will need a licensed faculty preceptor.
   • If schools do not already have a student based health center they will need an agreement
      with their LHD.
   • Medical students and residents must demonstrate to LHDs they have received infection
      control training.

Below are links to all of the registered Physician Assistant and medicine programs in New York
State.
    • Medicine
       http://www.New York Stateed.gov/COMS/RP090/IRP2BB
    • PA Programs- Below Bachelors Degree Level
       http://www.New York Stateed.gov/COMS/RP090/IRP2BB
    • PA Programs- Bachelors Degree or Higher
       http://www.New York Stateed.gov/COMS/RP090/IRP2BB

Below is the link to the American Council on Graduate Medical Education, the body that
regulates residency training. All of the residency programs in New York State are listed therein.

   •   Residency Programs
       http://www.acgme.org/adspublic/


   E. Nursing Students (For a list of nursing schools, please see Appendix H)

            • Registered Professional Nursing (RN) Students
Registered Professional Nursing students can be immunizers as long as it is part of their clinical
training program. In order for that to occur there needs to be an affiliation agreement between
the school and the LHD that identifies the immunization clinic as a part of the curriculum. The
school needs to provide supervision just as for any clinical rotation. A list of nursing schools in
New York State is attached.

Considerations

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   •   Schools need to provide supervision.
   •   An affiliation agreement is needed between school and LHD.
   •   Clinical site is responsible for ensuring students are CPR certified.

           • Licensed Practical Nursing (LPN) Students
LPN students can assist in immunizing as long as the experience is part of their clinical training
program and an affiliation agreement exists between the schools and the LHD. The agreement
must identify the immunization clinic as part of their curriculum and those LPNs are unable to
conduct assessments.

Considerations
   • LPNs require constant supervision and oversight by RN.
   • LPNs are not able to conduct assessments.
   • LPN program is 9 months and clinical experience may not fall within timeframe of novel
      H1N1 influenza monovalent vaccination.
   • Clinical site is responsible for ensuring students are CPR certified.

           •    School of Public Health Students (For a list of schools of public health, please
                        see Appendix H)
Schools of Public Health offer degrees in the basic disciplines that constitute public health and
offer students the ability to acquire the academic and practical skills necessary to work in the
field of public health. Students are offered a vast array of internships and the planning and
staffing for mass vaccination clinics during the novel H1N1 influenza response may provide an
excellent learning opportunity.

           • Pharmacy Interns
Pharmacy interns are another possible supplemental sources of vaccinators. This possibility is
being explored by the NYSDOH and the New York State Education Department.

             • Emergency Medical Services (EMS) Personnel and/or EMS Students
It is currently outside of the scope of practice for currently certified EMS Providers and/or EMS
students to administer vaccine even if they are otherwise certified (EMT-Critical Care and EMT-
Paramedic levels) to administer injections. If an Executive Order is decreed to allow this, just-in-
time training will be provided.

       • Continuing Actions
NYSDOH will:
  • Continue to explore volunteer options with medical professional schools;
  • Continue to address legal issues surrounding volunteers and the ability of persons to
    vaccinate outside of their usual work roles.
  • Provide contracts with mass and community vaccinators for LHDs to access.
  • Provide medical and non-medical temporary staff for LHDs to access.

LHDs will:
  • Explore the use of all types of volunteers for use at vaccination clinics.
  • Develop a staffing plan for all vaccination efforts undertaken.

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   F. Vaccine Monitoring

The VAERS will be the primary means for monitoring vaccine adverse events during the Novel
H1N1 Influenza Vaccination Campaign. Other methods of monitoring are discussed above. The
NYSDOH will inform LHDs if any other monitoring requirements or opportunities arise. LHDs
should report any adverse events to VAERS electronically, by fax, or by phone. Information on
VAERS can be obtained at the VAERS website at www.vaers.gov.

NYSDOH will:
  • Provide clinical consultation on adverse events if needed or desired.
  • Provide information on the VAERS system and how to report for medical providers in
    the community.
  • Engage in active surveillance for Guillain Barre Syndrome.
  • Inform all LHDs and providers immediately if any safety concerns arise in the course of
    the vaccination campaign.
  • Receive weekly reports from VAERS on adverse events that have occurred in New York
    State and report on the information to LHDs.

LHDs will:
  • Report any adverse events to VAERS.
  • Encourage medical providers to report to VAERS.

   G. Clinical Management

LHDs are experienced vaccinators and are not in need of basic information on immunization.
However, there will be medical providers who want to vaccinate who may not be actively
vaccinating in their practices, such as obstetricians, may not have vaccinated in a long time, or
who have little experience receiving vaccine through the government. In addition, there may be
unique clinical issues that surround vaccination with novel H1N1 influenza monovalent vaccine.
The NYSDOH is planning written materials, presentations and webinars to educate all types of
medical providers. The NYSDOH Bureau of Immunization is also available for technical
support and to answer clinical questions surrounding vaccination.

NYSDOH will:
  • Provide a toolkit for medical providers.
  • Provide a toolkit for vaccinating in schools.
  • Provide educational opportunities including presentations and webinars.
  • Provide continued outreach to medical professional societies and health care facility
    associations.
  • Provide continued outreach to health plans.
  • Provide continued outreach to health care personnel.
  • Provide technical support and answer clinical questions.
  • Use CDC materials as indicated.
  • Provide frequent updates on vaccination information.

LHDs will

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   •   Assist in the dissemination of NYSDOH and CDC materials.
   •   Participate in educational and other events or conference calls.
   •   Assist medical providers in the county with clinical concerns and questions.

   H. Information Technology in Support of Vaccination Distribution

A description of the plans for tracking vaccination information is found above. The NYSIIS will
be the primary mechanism for recording all novel H1N1 influenza monovalent vaccine. NYSIIS
will be required for pediatric immunizations and strongly encouraged for adult vaccine
providers. LHDs do have the option of using the CDMS at PODs or clinics. The NYSDOH is
working on an electronic solution so that data can be transferred from CDMS directly into
NYSIIS.

All LHDs, most pediatric practices, many pharmacists, some mass vaccinators, and many
hospitals are already using NYSIIS and are familiar with it. However, adult practices that join in
the novel H1N1 influenza campaign may not be familiar with NYSIIS and may express concern
over using it. NYSIIS staff in the Bureau of Immunization is available to assist all potential
users of NYSIIS and to support them once they are on the system. In addition, NYSIIS is able to
exchange data with many more than 47 electronic health record/billing systems used by medical
practices. See Appendix I for list of medical billing software that is NYSIIS Compatible. If a
provider using one of these software vendors, NYSIIS staff is often able to set that up quickly.

All vaccination information on children less than 19 years of age is required to be entered in to
NYSIIS according to public health law. At present, however, all information on adults requires
consent before information can be entered. LHDs should plan to obtain consent after to enter
vaccination information on adults into NYSIIS. If an adult refuses to allow his or her
information to be entered, he or she can still receive an immunization.

NYSDOH will:
  • Change data entry screens in NYSIIS to accommodate event/campaign information and
    selection of priority group for patients.
  • Add new novel H1N1 influenza monovalent vaccine codes to NYSIIS database tables to
    support manual data entry and data exchange from providers.
  • Modify NYSIIS scheduler to accommodate one or two dose schedule based on clinical
    trial results.
  • Explore options to eliminate the need for a written NYSIIS consent form for persons 19
    years of age and older.
  • Increase NYSIIS training activities for pediatricians, family physicians, OB/GYNs, and
    adult providers, as well as hospital occupational/employee health service clinics and other
    health care facilities vaccinating their health care workers.
  • Disseminate information regarding NYSIIS training opportunities widely to interested
    providers.
  • Encourage the identification of clinic locations where internet access is available for real-
    time query and data entry capability.
  • Support the use of electronic data exchange from new providers using EHR/billing
    vendors that are already successfully uploading data to NYSIIS.


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   •   Develop CDMS v1.5 web application to support the needs of the LHDs which choose to
       use the system in their mass vaccination efforts.
   •   Redesign the CDMS paper to include additional data elements required for record
       matching in NYSIIS and to meet the data collection requirements for the novel H1N1
       influenza campaign. Optical Character Recognition (OCR) will not be available to
       extract the form data.
   •   A manual data entry process will be used to input the CDMS form data from the
       uploaded image. Medication barcodes will be interpreted by OCR.
   •   The form data will be stored in the CDMS database. The form images will be retained in
       a central repository but will not be available for user retrieval.
   •   Crosswalk variables and investigate file transfer specifications to develop data exchange
       file upload from CDMS to NYSIIS.
   •   Data will be extracted from the CDMS database to upload to NYSIIS on a regular basis
       during the campaign.
   •   Identify public facing webpage to begin provider registration process that will allow the
       submission of an application for Health Commerce System account access, express
       interest with the vaccine program in receiving the novel H1N1 influenza monovalent
       vaccine, and assist with registering for NYSIIS training.
   •   Disseminate information regarding provider registration process widely so all interested
       providers are aware of the need to pre-register. Please see Appendix E for instructions on
       pre-registering.
   •   Provide information the LHDs regarding which providers have pre-registered for novel
       H1N1 influenza monovalent vaccine.
   •   Coordinate with the New York State Office for Technology to establish a replicated
       NYSIIS database within the NYSDOH network to allow greater access to data for
       analytic purposes.
   •   Provide timely, accurate and complete data to local, state and national stakeholders
       including weekly CDC aggregate reporting requirements.
   •   Investigate the ability for NYSDOH to pre-populate inventory information (trade name,
       manufacturer, lot #) from the logistical/distribution group into NYSIIS to reduce data
       entry requirements for vaccinating organizations.
   •   Train current and new users on the ability to record reactions in NYSIIS.
   •   Investigate ability to share immunization histories with health insurers for their plan
       participants, to link with health care service utilization data and identify any possible
       associations.

LHDs will:
  • Encourage all providers in the county to enroll in the Health Commerce System.
  • Disseminate information regarding NYSIIS training opportunities widely to interested
     providers.
  • Encourage the identification of clinic locations where internet access is available for real-
     time query and data entry capability.
  • Plan for the need to obtain consent to enter novel H1N1 influenza vaccination
     information into NYSIIS in the absence of an emergency declaration.
  • Use the existing scanning and upload process to send the scanned CDMS paper form
     images to the Health Commerce System.

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    •   Ensure all vaccination information is reported in a timely manner using NYSIIS or
        CDMS.
    •   Disseminate information regarding provider registration process widely so all interested
        providers are aware of the need to pre-register. (LHDs do not have to register with the
        NYSDOH to receive vaccine.)
    •   Use NYSIIS or other tracking system to track inventory distributed from LHDs.
    •   Use NYSIIS or other tracking system to monitor adverse events the LHD becomes aware
        of.
    •   Assist additional adult and OB providers with NYSIIS data entry.

XII. Resources:

Global, National, State and City Resources

World Health Organization: Global alert and response, guidance documents, FAQ’s etc.
http://www.who.int/csr/disease/swineflu/en/index.html

U.S. Government Swine, Avian and Pandemic Flu Information - One-stop access
From the U.S. Department of Health and Human Services
http://www.flu.gov/

CDC Novel H1N1: Clinical guidance
http://www.cdc.gov/h1n1flu/clinicians/

CDC Novel H1N1: Vaccination guidance for state, local and territorial health officials
http://www.cdc.gov/h1n1flu/vaccination/statelocal/

Food and Drug Administration (FDA): Use of Influenza Medicines and Diagnostic Testing Information
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm150305.htm

New York State Department of Health: H1N1 Guidance
http://www.nyhealth.gov/diseases/communicable/influenza/h1n1/

New York State Office of Homeland Security
http://www.security.state.ny.us/preparedness/index.html

New York State Department of Insurance: Information on Vaccine Insurance Requirements
http://www.ins.state.ny.us/health/ih_hreqimmun.htm

New York City Department of Health and Mental Hygiene
http://www.nyc.gov/html/doh/html/cd/cd-h1n1flu.shtml


Clinical Information, Literature Reviews and Updates

New England Journal of Medicine:
http://h1n1.nejm.org/?emp=marcom

Center for Infectious Disease Research & Policy Academic Health Center -- University of Minnesota
http://www.cidrap.umn.edu/

American Medical Association
http://www.ama-assn.org/ama/pub/physician-resources/medical-science/infectious-diseases/topics-interest/novel-
influenza-a-h1n1.shtml

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American Academy of Pediatrics
http://www.aap.org/advocacy/releases/may09swineflu.htm

American Academy of Family Physicians
http://www.aafp.org/online/en/home/clinical/disasterprep/swine-flu.html

American College of Obstetricians and Gynecologists: Resource List
http://www.acog.org/departments/dept_notice.cfm?recno=20&bulletin=4866




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Attachment 5: Acronyms

                                         Acronyms

AE                            Adverse Events
ACIP                          Advisory Committee on Immunization Practices
AIIR                          Airborne Infection Isolation Room
ARDS                          Acute Respiratory Distress Syndrome
BCDC                          NYSDOH Bureau of Communicable Disease Control
BHNSM                         NYSDOH Bureau of Healthcom Network Systems Management
BHAE                          NYSDOH Bureau of HIV/AIDS Epidemiology
BNE                           NYSDOH Bureau of Narcotics Enforcement
BSTDC                         NYSDOH Bureau of Sexually Transmitted Disease Control
BTBC                          NYSDOH Bureau of Tuberculosis Control
CDC                           Centers for Disease Control and Prevention
CDESS                         Communicable Disease Electronic Surveillance System
CDMS                          Clinic Data Management System
CERC                          Crisis Emergency Risk Communication
CLIMS                         Clinical Laboratory Information Management System
CMRTS                         Counter Measure Resource Tracking Systems
CoSuR                         County Surveillance and Reporting System (LHD HERDS)
DAV                           Data Analysis and Visualization
DPC                           Disaster Preparedness Commission
EAS                           Emergency Alert System
ED                            Emergency Department
EDB                           Executive Dash Board
ECLRS                         NYSDOH Electronic Clinical Laboratory Reporting System
EIP                           Emerging Infections Program
EMS                           Emergency Medical Services
EPA                           Environmental Protection Agency
ESAR-VHP                      Emergency System for the Advance Registration of Volunteer
                              Health Professionals (now called ServNY)
EUA                           Emergency Use Authorization
FDA                           Food and Drug Administration
FEMA                          Federal Emergency Management Agency
GIS                           Geographical Information System
HAN                           Health Alert Network
HCS                           Health Commerce System
HERDS                         Health Emergency Response Data System
HHA                           Home Health Agency
HHS                           U.S. Department of Health and Human Services
HIN                           Health Information Network
HOC                           Health Operations Center
HPAI                          Highly Pathogenic Avian Influenza
HPN                           Health Provider Network
HSB                           NYSDOH Healthcom Services Bureau
IATA                          International Air Transport Association
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ICP                           Infection Control Professional
ICS                           Incident Command System
ILI                           Influenza-like illness
IMS                           NYSDOH Incident Management System
IND                           Investigational New Drug
IHANS                         Integrated Health Alerting and Notification System
IRB                           Institutional Review Board
ISHSG                         NYSDOH Information Systems and Health Statistics Group
IVR                           Interactive Voice Response
JIC                           Joint Information Center
LAIV                          Live Attenuated Influenza Vaccine
LHD                           Local Health Department
LMP                           Licensed Medical Professional
LTCF                          Long Term Care Facility
MAA                           Mutual Aid Agreement
MOU                           Memoranda of Understanding
MRC                           Medical Reserve Corps
NHSN                          National Healthcare Safety Network
NORA                          Nosocomial Outbreak and Reporting Application
NREVSS                        National Respiratory and Enteric Virus Surveillance System
NYCDOHMH                      New York City Department of Health and Mental Hygiene
NEW YORK STATEDAM             New York State Department of Agriculture and Markets
NEW YORK STATEDEC             New York State Department of Environmental Conservation
NYSDOH                        New York State Department of Health
NYSIIS                        New York State Immunization Information System
OEM                           Office of Emergency Management
OHEP                          Office of Health Emergency Preparedness
OSPH                          NYSDOH Office of Science and Public Health
PAG                           NYSDOH Public Affairs Group
PHL                           Public Health Law
PIO                           Public Information Office/Officer
POD                           Point of Dispensing
PPE                           Personal Protective Equipment
PWSA                          Public Web Site Administration
SDF                           Secure Discussion Forum
SEMO                          New York State Emergency Management Office
SERV-NY                       Formerly known as Emergency System for the Advance
                              registration of Volunteer Health Professionals (ESAR-VHP)
SNS                           Strategic National Stockpile
SO                            Surveillance Officer
SPN                           United States Influenza Sentinel Provider Network
USDA                          United States Department of Agriculture
VAERS                         Vaccine Adverse Events Reporting System
VC                            Video Conference
VIS                           Vaccine Information Statement
WHO                           World Health Organization



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