ASSESSING POLICY BARRIERS 

TO 

EFFECTIVE PUBLIC HEALTH RESPONSE 

IN THE 

H1N1 INFLUENZA PANDEMIC

PROJECT REPORT 

TO THE 

CENTERS FOR DISEASE CONTROL AND PREVENTION

June 2010 

Association of State and Territorial Health Officials 

   
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Association of State and Territorial Health Officials Page 2 

Acknowledgements 

ASTHO thanks the state and territorial health officials and state and territorial health agency staff for their 

assistance in providing data and insights for this report. State and territorial health agency personnel have 

given freely of their time to contribute to this and many other evaluations of the public health system’s 

response to the 2009 H1N1 pandemic influenza outbreak. 

This report was made possible through funding from the Centers for Disease Control and Prevention 

(CDC) Cooperative Agreement to Improve the Nation’s Public Health Infrastructure with State Public 

Health Agencies. ASTHO would like to thank project managers Jean O’Connor, JD, DrPH, Deputy 

Planning and Evaluation Officer, and Amy Feuss, JD, Public Health Analyst, with the CDC Office of 

Public Health Preparedness and Response. The contents of this report are solely the responsibility of 

ASTHO and do not necessarily represent the official views of the CDC. 

This project was conducted under the technical direction and oversight for ASTHO by James 

Blumenstock, MA, Chief, Public Health Practice, and Charlotte Hyams Porter, MPH, Senior Director, 

Public Health Preparedness. ASTHO staff members Anna DeBlois Buchanan, MPH, Senior Director, 

Immunization and Infectious Disease, and Caroline Barnhill, MPH, Director, Emerging Diseases, also 

contributed to the project. 

The report was written for ASTHO by Patricia I. Elliott, JD MPH, President, Logan Circle Policy Group 

LLC | 202-683-4114 | info@Logan.CirclePolicyGroup.com | www.LoganCirclePolicyGroup.com. 

Association of State and Territorial Health Officials 

2231 Crystal Drive, Suite 450 

Arlington, VA 22202 

Tel 202-371-9090 Fax 571-527-3189 

www.astho.org 

 
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Contents 

Executive Summary........................................................................................... 4

Introduction........................................................................................................ 8

I. Project Elements and Methodology............................................................... 11

II. Overview of Barriers and Priorities for Action................................................ 15

III. Compilation of Barriers Identified.................................................................. 34

 A. ICS, Command and Control, and Authority............................... 36

 B. Surveillance, Epidemiology, and Laboratory Services.............. 53

 C. Medical Care and Countermeasures........................................ 64

 D. National Vaccination Campaign................................................ 92

 E. Workforce, Capacity, and Infrastructure.................................... 118

 F. Federal/State/Local Coordination.............................................. 130

 G. Communication......................................................................... 146

Appendices 

 Appendix 1: Project Advisory Panel Meeting Agenda and 

Attendees List 

 Appendix 2: State Meetings Summary Report 

ASTHO H1N1 Policy Barriers Project State 

Meetings: Summary and Analysis

 Appendix 3: Survey Report 

ASTHO Survey of State Health Agencies on H1N1 

Response Policy and Legal Issues: Summary and 

Analysis

 Appendix 4: Environmental Scan Report 

Environmental Scan of H1N1 Reviews and AfterAction Reports: Identifying Policy and Legal Issues

 
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Executive Summary 

A novel influenza virus emerged in April 2009 and by June 2009 had created such widespread concern 

over its potential to cause global illness and death that the World Health Organization (WHO) declared an 

influenza pandemic. The novel H1N1 pandemic prompted a massive and coordinated response from the 

U.S. public health system, which provided the first opportunity to implement state and federal pandemic 

influenza plans in a real-world setting. While the nation’s combined response efforts were commendable, 

all involved also acknowledged that the policies and plans did not fully anticipate or address the specific 

events and circumstances which unfolded during the H1N1 outbreak. 

Project Background and Description 

The Centers for Disease Control and Prevention (CDC) funded the Association of State and Territorial 

Health Officials (ASTHO) to conduct a special project, Assessing Policy Barriers to Effective Public 

Health Response to the H1N1 Influenza Pandemic, to systematically identify and assess key policy 

barriers encountered during the H1N1 response. For the purposes of the project, ASTHO defined a 

“policy barrier” as a plan, course of action, principle or procedure adopted by a governmental entity 

which impeded or impaired an agency’s/jurisdiction’s ability to more effectively respond to the H1N1 

public health emergency. A policy barrier could be of a legal (e.g., a federal or state statute, regulation, or 

other legal authority) or non-legal (e.g., federal or state administrative order, agency guidance) nature, 

and of national, regional or intrastate scope. The goal of the project was to advance continued 

strengthening and overall improvement in the national public health system’s collective capabilities to 

effectively respond to future pandemics and other emerging threats by addressing the barriers encountered 

during the H1N1 response. 

The H1N1 Policy Barriers Project differed from typical after-action reviews (AARs), which look at both 

areas of success and areas for improvement, by focusing almost exclusively on policy and legal barriers. 

As such, the project did not actively seek out information about successful elements of the H1N1 

response, which were many. This information was, however, included in the project to the extent states 

provided it. 

There were four elements to the ASTHO H1N1 Policy Barriers Project: (1) an environmental scan; (2) a 

state survey; (3) state H1N1 response review meetings; and (4) the project advisory panel meeting. 

ASTHO specified the following eight categories for use by the states in classifying the barriers: (A) ICS, 

Command and Control, and Authority; (B) Surveillance, Epidemiology, and Laboratory Services; (C) 

Medical Care and Countermeasures; (D) National Vaccination Campaign; (E) Workforce, Capacity, and 

Infrastructure; (F) Federal/State/Local Coordination; (G) Communications; and (H) Other. The same list 

of categories was used in all project activities (scan, survey, meetings, and advisory panel) to provide a 

common framework in which to compile and analyze the large amounts of data gathered during the 

project. 

 Environmental Scan 

The environmental scan compiled and analyzed prior observations about the policy and legal issues 

that arose during H1N1 response efforts. Data for the scan was drawn from the numerous in-progress 

reviews (IPRs), AARs, and other evaluations of the H1N1 response and recent general pandemic 

preparedness reviews conducted in 2009 and early 2010. State AARs, which are in the process of 
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being developed, were not included in the environmental scan. Priority was given to IPRs, AARs, and 

other evaluations by agencies and organizations involved in preparing for and responding to the 

outbreak.

 H1N1 Policy Barriers State Survey 

ASTHO deployed a survey to state and territorial health officers, senior deputies, agency-assigned 

public health lawyers, directors of public health preparedness, and immunization managers inquiring 

about policy barriers they encountered in their H1N1 response activities. Respondents were asked to 

identify and discuss the top five policy or legal barriers they encountered during the H1N1 response. 

Respondents were asked to categorize their responses into one of the above eight categories specified 

by ASTHO.

 State H1N1 Response Review Meetings 

ASTHO invited five states to conduct H1N1 response review meetings to identify and discuss key 

policy barriers. Participating states agreed to hold the review meeting and submit a written report to 

ASTHO. These response review meeting were not intended to be a substitute for participating states’ 

H1N1 AARs. All states are in the process of completing full AARs and other evaluations in the 

aftermath of H1N1.

 Project Advisory Panel Meeting 

ASTHO held a meeting of the H1N1 Policy Barriers Project Advisory Panel to review data compiled 

from the first three elements, identify top priorities for action, and make recommendations for 

mitigating the priority barriers.

Project Report 

This report is a synthesis of the many observations, comments and professional opinions on policy 

barriers encountered which have been shared by contributing state and territorial public health officials; it 

is not being represented as a consensus of the practice community. It was prepared in the spirit of 

collaboration and with the expectation that it will significantly contribute to the body of knowledge on the 

nation’s public health response to the 2009-10 H1N1 Pandemic and will help elucidate key policy barriers 

and considerations warranting attention into order to improve our collective state of readiness for the next 

pandemic or other major public health event. 

ASTHO combined information about the hundreds of policy barriers identified through the survey, state 

response review meetings and the environmental scan, and compiled them into this report, Assessing 

Policy Barriers to Effective Public Health Response in the H1N1 Influenza Pandemic: Project Report to 

the Centers for Disease Control and Prevention (the “Policy Barriers Project Report”). The Policy 

Barriers Project Report includes the top policy barriers identified by the Advisory Panel, discusses other 

key issues that emerged from the project, and provides detailed information about all the identified 

barriers, mitigation strategies, and suggestion recommendations from state participants. The most 

frequently identified issues in each of the categories are briefly listed below. 

 ICS, Command and Control, and Authority 

H1N1 response command and incident command systems (ICS); federal and state emergency 

declarations; statutory and regulatory waivers, Public Readiness and Emergency Preparedness Act 

(PREP) Act questions and general liability concern; and school closure and other community 

mitigation strategies.
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 Surveillance, Epidemiology, and Laboratory Services 

Surveillance, data collection and analysis; reporting estimated cases, deaths and hospitalizations; and 

laboratory services capacity.

 Medical Care and Countermeasures 

Medical care and countermeasures allocation, prioritization and guidance; stockpiles, inventory 

management and supply chains; administration and dispensing sites/practices; tracking, coverage and 

adverse events reporting; recovery, destruction and disposal; N95 and personal protective equipment 

(PPE) guidance; emergency use authorizations; and medical equipment tracking.

 National Vaccination Campaign 

Vaccine availability, formulation, allocation, prioritization and guidance; ordering, delivery, and 

distribution; administering and dispensing; tracking, coverage, recalls, and adverse events reporting; 

and recovery, destruction and disposal.

 Workforce, Capacity, and Infrastructure 

Public health workforce surge capacity; health care and medical surge capacity; volunteer surge 

capacity; worker protection and employment; and workforce mandates.

 Federal/State/Local Coordination 

Coordination within and among federal, state and local agencies; Public Health Emergency Response 

(PHER) grants; flexing federal funding; state systems and operations; and pandemic influenza 

planning.

 Communication 

Messaging coordination and capacity; H1N1/vaccination ad campaigns and messaging; public and 

media outreach; communication with health care providers and other stakeholders; and outreach to 

minority communities and special/vulnerable populations.

Priority Policy Barriers for Action 

The Advisory Panel identified the following policy barriers for priority action. The Policy Barriers 

Project Report contains a detailed discussion of each of the barriers and identifies a series of 

recommendations to address them. 

1. More consistent use of a unified command structure during the H1N1 outbreak would have 

benefited the response at all levels of government. 

2. Delays in vaccine production and changing messages about its availability caused confusion for 

the public and damaged the credibility of governmental public health at all levels. 

3. More consistency is needed nationally regarding surveillance strategies, data collection and 

analysis. 

4. Federal stockpiling decisions affected state and local response activities and influenced the supply 

chain of key medical countermeasures. 

5. Delays and conflicts in federal guidance on respiratory protection (N95) led to confusion, caused 

shortages in supplies, and delayed the release of state and local stockpiles. 
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6. Public Health Emergency Response (PHER) grants provided states with the resources necessary 

to mount H1N1 response activities but the format and requirements for managing the grants were, 

to some extent, burdensome and time consuming. 

7. The H1N1 response strained public health laboratory capacity at the federal and state levels. 

8. Flexing the public health workforce was a challenge especially given restrictions on federallyfunded positions at the state and local levels. 

9. Federal, state and local health agencies need to use new and more effective strategies to reach 

special and vulnerable populations and minority communities. 

Other Key Issues 

 “New” and “Old” Issues 

Through discussions with the Advisory Panel and after reviewing the various project elements 

(survey, meetings, scan) it became evident that the national H1N1 response efforts highlighted 

challenges that emerged from the unique circumstances of the H1N1 outbreak (“new” issues), as well 

as revealed issues that seem to recur frequently in public health emergencies (“old” issues). Examples 

of the issues emerging during the H1N1 outbreak included the dynamics of the N95 guidance, school 

closure guidance, and PREP Act questions. Examples of the recurring issues included the ability to 

flex and surge public health workers, concerns about laboratory capacity, and liability fears by staff 

and volunteers. The characterization of issues as “old” or “new” is not intended to diminish the 

importance of an item; it is simply to demonstrate that unanticipated issues/barriers will arise with 

each public health emergency and that work remains to be done on other issues/barriers.

 Relationships among Barriers 

Comments received from the Advisory Panel and the input of states throughout the project 

emphasized the relationships and connections among barriers. In any response, a decision made about 

one issue will cause both intended and unintended consequences in other areas. The Policy Barriers 

Project Report highlights the following three examples: (1) command, coordination and 

communication; (2) legal authorities and liability concerns; and (3) public health capacity and 

funding.

 Structural Issues 

States’ responses and other sources reviewed for the H1N1 Policy Barriers Project revealed ongoing 

structural challenges that are affecting the nation’s capacity to respond to emergencies, as well as to 

engage in daily public health and health care activities. The three structural challenges identified in 

the report are: (1) public health workforce and infrastructure capacity; (2) health care system 

capacity; and (3) supply chain issues.

 Pending Issues 

The Policy Barriers Project Report also highlights several outstanding public health preparedness 

issues that did not feature prominently during the H1N1 response, but which likely would have been 

more significant had the H1N1 virus been more virulent. States identified the following issues as 

items still needing more attention by federal, state and local governments: (1) alternative/crisis 

standards of care; (2) alternate care sites; (3) quarantine/isolation and travel restrictions; and (4) 

refining pandemic plans.

 
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Introduction 

A novel influenza virus emerged in April 2009 and by June 2009 had created such widespread concern 

over its potential to cause global illness and death that the World Health Organization (WHO) declared an 

influenza pandemic. The novel H1N1 pandemic prompted a massive and coordinated response from the 

U.S. public health system. It provided the first opportunity for the public health system to implement the 

national response strategy and the states’ pandemic influenza operational plans in a real-world setting. 

While the nation’s combined response efforts were commendable, all involved also acknowledged that 

the policies and plans did not fully anticipate or address the specific events and circumstances which 

unfolded during the H1N1 outbreak. 

The Centers for Disease Control and Prevention (CDC) funded the Association of State and Territorial 

Health Officials (ASTHO) and the National Association of County and City Health Officers (NACHHO) 

to conduct a special project, Assessing Policy Barriers to Effective Public Health Response to the H1N1 

Influenza Pandemic, to systematically identify and assess key policy barriers—both legal and non-legal—

encountered during the H1N1 response and offer a course of action to address these barriers. The goal of 

the project was to advance continued strengthening and overall improvement in the national public health 

system’s collective capabilities to effectively respond to future pandemics and other emerging threats by 

addressing the barriers encountered during the H1N1 response. 

The H1N1 Policy Barriers Project differed from typical after-action reviews (AARs), which look at both 

areas of success and areas for improvement, by focusing almost exclusively on policy and legal barriers. 

As such, the project did not actively seek out information about successful elements of the H1N1 

response, which were many. However, the report captures information about H1N1 response successes to 

the extent that states’ provided that information. 

It is also important to note that the H1N1 Policy Barriers Project was not intended to be a substitute for 

states’ and territories’ H1N1 AARs nor was the timing such to capture and consider the states’ and 

territories’ AAR findings for possible inclusion in this report. All jurisdictions are in the process of 

completing full AARs and other evaluations in the aftermath of H1N1. 

Project Elements 

There were four elements to ASTHO’s H1N1 Policy Barriers Project: 

 Environmental scan of in-progress reviews, after-action reviews, and other evaluations of H1N1 

response activities; 

 Survey of state and territorial health officials and key agency staff; 

 H1N1 response review meetings conducted in five selected states; and 

 H1N1 Policy Barriers Project Advisory Panel meeting to review findings from the first three 

elements, identify top priorities for action, and make recommendations for mitigating the priority 

barriers. 

Using all of these elements, ASTHO created a composite picture of the barriers identified, their impacts, 

and states’ suggestions for mitigating the barriers’ effects with the goal of improving the outcomes of 
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future public health responses. ASTHO retained Logan Circle Policy Group LLC to assist with each 

phase of the project, write reports analyzing each of the project elements, and write a comprehensive final 

project report for ASTHO that compiled and analyzed the data and recommendations from each phase. 

This report is a synthesis of the many observations, comments and professional opinions on policy 

barriers encountered which were shared by contributing state and territorial public health officials; it is 

not being represented as a consensus of the practice community. It was prepared in the spirit of 

collaboration and with the expectation that it will significantly contribute to the body of knowledge on the 

nation’s public health response to the 2009-10 H1N1 Pandemic and will help elucidate key policy barriers 

and considerations warranting attention into order to improve our collective state of readiness for the next 

pandemic or other major public health event. 

Defining “Policy Barrier” 

For the purposes of the project, ASTHO defined a “policy barrier” as a plan, course of action, principle or 

procedure adopted by a governmental entity which impeded or impaired an agency’s/jurisdiction’s ability 

to more effectively respond to the H1N1 public health emergency. Barriers described through this project 

warrant remedial consideration since they will most likely recur in a future emergency. A policy barrier 

can be of a legal (e.g., a federal or state statute, regulation, or other legal authority) or non-legal (e.g., 

federal or state administrative order, agency guidance) nature, and of national, regional or intrastate 

scope. While important, it was not the primary intent of this project to capture issues of concern dealing 

with the operational, logistical, and administrative elements of the response; such issues were considered 

to the extent they revealed underlying policy and legal barriers. 

To assist the states and territories in identifying potential policy and legal barriers, ASTHO created a list 

of policy barrier categories. The list provided was neither exhaustive nor was it intended to lead or narrow 

participants’ identification of barriers; it was intended to prompt thought and stimulate recall of important 

issues that arose during H1N1 response activities. (See Table 1 below for the complete categories list.) 

The same list of categories was used in all project activities (scan, survey, meetings, advisory panel) to 

provide a common framework in which to compile and analyze the large amounts of data gathered about 

the public health system’s response to H1N1. 
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ICS, Command and Control, and Authority 

• H1N1 Response Command 

• Emergency Declarations 

• School Dismissal/Closure and Community Mitigation 

Measures 

• Quarantine/Isolation/Travel Restrictions 

• National Guidance/Standards 

• Liability Protections 

• PREP Act (General) 

Surveillance, Epidemiology, and Laboratory Services 

• Laboratory Services 

• Epidemiology 

• Surveillance Data Collection/Analysis 

• Reporting of Estimated Cases, Deaths and 

Hospitalizations 

• Surveillance Guidance/Policies 

• Surveillance, Epidemiology, and Laboratory Services 

(General) 

Medical Care and Countermeasures

• Identification/Formulation 

• Manufacture 

• Stockpiling and Distribution 

• Commercial Supply Chain Visibility 

• Countermeasure Response and Administration (CRA) 

System 

• Delivery/Administering 

• Emergency Use Authorization 

• PPE/Infection Control Procedures and/or Requirements 

(including N95 Respiratory Protection) 

• Adverse Events Reporting 

• EMTALA and HIPAA 

• HAvBED Reporting 

• Countermeasures Injury Compensation 

• Medical Care and Countermeasures Guidance/Policies 

• Medical Care and Countermeasures General 

Workforce, Capacity, and Infrastructure 

• Flexing Existing Staff 

• Surge Capacity (e.g., public health, health care, 

pharmacy) 

• Volunteers 

• Workforce Mandates (e.g., vaccination) 

• Workforce/ Capacity/Infrastructure (General)

National Vaccination Campaign 

• Formulation and Manufacture 

• Allocation Approaches 

• Stockpiling and Distribution 

• Delivery/Administering 

• Reporting of doses administered (vaccine and/or 

antivirals); Tracking for recall of pediatric second dose 

vaccination 

• Liability Protection 

• Vaccination Authority (e.g., efforts to expand the pool of 

vaccinators by including dentists or a broader age 

range for pharmacist vaccination) 

• Inventory Management 

• Reimbursement for Services (including CMS Medicaid 

and CHIP) 

• Adverse Events Reporting 

• Coverage Determination and Reporting 

• Vaccination Guidance/Policies 

• Vaccination (General) 

Federal/State/Local Coordination 

• Categorical Grant/Cooperative Agreement Flexibility 

• Common Operating Picture/Platform 

• Public Health and Health Care Sector Interaction 

• Stakeholder Engagement 

• PHER Grants 

• Technical Assistance 

• Stafford Act Applicability and Provisions 

• Coordination (General) 

Communication 

• Media relations and ad campaign efforts 

• Public outreach 

• Stakeholders 

• Policy Makers 

• FOIA Requests and Disposition 

• Communication (General) 

Other 

• Issues not arising under other thematic areas 

• Unintended Consequences/Conflicts (areas in which a 

law/policy to address one issue had unintended 

consequences/conflicts in another area). 

TABLE 1 

ASTHO H1N1 Policy Barriers Project Potential Policy Barrier Categories 
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I. Project Elements and Methodology 

Section I briefly describe each element of the ASTHO H1N1 Policy Barriers Project. These elements are: 

(A) state agency staff survey; (B) state H1N1 response review meetings; (C) environmental scan; and (D) 

H1N1 Policy Barriers Project Advisory Review Panel meeting. 

I.A State Survey 

ASTHO deployed a survey on April 2, 2010 to state and territorial health officers, senior deputies, 

agency-assigned public health lawyers, directors of public health preparedness, and immunization 

managers inquiring about policy barriers they encountered in their H1N1 response activities. ASTHO did 

not require states to consolidate all responses from a state into a single response. This allowed for quicker 

completion of the survey, as well as a more robust range of views. Respondents were asked for, but not 

required to provide, their name, agency, and state affiliation. The views represented in the survey 

responses are those of the individual respondents; they do not necessarily reflect the official views of the 

states and territories. 

Respondents were asked to identify and discuss the top five (5) policy or legal barriers they encountered 

during the H1N1 response. Respondents were instructed that the first item listed should represent their 

highest priority for attention; the second should be the next highest priority, and so on, through the five 

barriers identified. For each of the policy barriers identified, respondents were asked to provide the 

following information: 

 A clear and succinct description/definition of each barrier and the legal and non-legal aspects of 

the barrier; 

 How the barrier impacted/impeded the public health response and its consequences; 

 What remedies or “work-arounds” were pursued and were they effective; and 

 Recommendations for corrective action(s) to remove the barrier. 

The survey instrument included a pull-down menu for respondents to assign their answers to one of eight 

(8) categories: 

 ICS, Command and Control, and Authority 

 Surveillance , Epidemiology, and Laboratory Services 

 Medical Care and Countermeasures 

 National Vaccination Campaign 

 Workforce, Capacity, and Infrastructure 

 Federal/State/Local Coordination 

 Communications 

 Other 
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ASTHO received completed surveys from 58 respondents, representing 26 states and 1 territory. Eighteen 

(18) respondents did not identify their state affiliation. A number of states submitted multiple responses. 

The survey respondents identified a total of 218 policy barriers. Some respondents listed less than five 

barriers, while a few indentified more than five barriers. 

The full text of the ASTHO Survey of State Health Agencies on H1N1 Response Policy and Legal Issues: 

Summary and Analysis is contained in Appendix 3. 

I.B. State H1N1 Review Meetings 

Five states participated in the H1N1 response reviews: Arizona, Colorado, New York, North Carolina, 

and Wisconsin. ASTHO invited these states to participate in the project based on their geographic 

distribution and range of experiences with H1N1. Participating states agreed to hold a review meeting and 

submit a written report to ASTHO. The states received a small stipend from ASTHO to cover meeting 

costs. 

It is important to note that the ASTHO H1N1 Policy Barriers Project reviews were not intended to be a 

comprehensive after-action review in which both successes and failures are evaluated. The focus of this 

project was to identify policy and legal barriers encountered in the H1N1 response with the goal of 

removing or alleviating them in future public health emergency response activities. As such, participating 

states were not required to include information about successful elements of the H1N1 response, which 

were many. To the extent that states’ provided information about H1N1 response successes, however, this 

information was included. Finally, the states’ reports for the ASTHO H1N1 Policy Barriers Project 

should not be considered to be the states’ H1N1 after-action reports required under other federal 

grants/cooperative agreements. The states will be releasing these separately at a later date. 

ASTHO provided the states with the following guidance regarding the content and format of their 

meetings. The guidance was provided to assure sufficient structure to yield a desired level of consistency 

and uniformity among the participating states, while allowing the states latitude in designing an approach 

and methodology to meet their individual needs and circumstances. 

Planning and Scheduling Guidance: Several key elements were to be considered: 

 Reviews were to be conducted by April 30, 2010. 

 Reviews were to be a day-long event or a reasonable portion thereof, in order to fully discuss and 

deliberate the issues. 

 An in-person event was preferred to the extent practicable, but ASTHO recognized that might not 

have been feasible. As such, teleconferences, videoconferences, and/or webinars were suitable 

alternatives. 

 Reviews could be a free-standing event or part of larger previously planned H1N1 after-action 

reviews. 

 Invited participants were to be of sufficient position to have a working knowledge of and 

exposure to the policies that were operational during the H1N1 response. 

 Invited participants were to represent a broad range of stakeholder interests including local public 

health and tribal entities; cross-sector agencies such as education, law enforcement, and 

emergency management; political leadership at a state and local level; health care providers; 

community and faith-based organizations; and the general public. 
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Documenting Policy Barriers: Participating states were provided with the list of categories (as seen in 

Table 1 above) to facilitate the reviews and assist in documenting their findings. ASTHO requested that, 

for each policy barrier identified, states collect the following information: 

 A clear and succinct description/definition of each barrier and the legal and non-legal aspects of 

the barrier; 

 How the barrier impacted/impeded the public health response and its consequences; 

 What remedies or “work-arounds” were pursued and an assessment of their effectiveness; and 

 Recommendations for corrective action(s) to remove the barrier. 

ASTHO did not expect the states to generate comprehensive lists of every federal and state, legal and 

non-legal barrier they encountered. ASTHO sought the states’ perspectives on what they identified as the 

three most significant barriers encountered warranting immediate action in each of the following 

categories: 

 ICS, Command and Control, and Authority 

 Surveillance , Epidemiology, and Laboratory Services 

 Medical Care and Countermeasures 

 National Vaccination Campaign 

 Workforce, Capacity, and Infrastructure 

 Federal/State/Local Coordination 

 Communications 

 Other 

While not a requirement of their project with ASTHO, each participating state was encouraged to also 

create a more detailed written record of the H1N1 barriers review proceedings for the state’s future 

reference. 

Each of the five states provided ASTHO with a written report of the issues/barriers identified in their 

respective meetings. The participating states identified a total of 110 issues/barriers. The data from these 

reports has been compiled and analyzed into a summary report, ASTHO H1N1 Policy Barriers Project 

State Meetings: Summary and Analysis, which is included in Appendix 2 of this document. 

I.C Environmental Scan 

The environmental scan component of the ASTHO H1N1 Policy Barriers Project was designed to 

identify, compile and analyze previous observations made about the policy and legal issues that arose 

during the public health system’s H1N1 response efforts. Data for the scan was drawn from the numerous 

prior in-progress reviews (IPRs), after-action reviews (AARs), and other evaluations of H1N1 response 

and recent general pandemic preparedness reviews conducted in 2009 and early 2010. State AARs, which 

are in the process of being developed, were not included in the environmental scan. Documents available 

as of May 1, 2010, were considered in this scan. 

The scan reviewed approximately 30 published or distributed sources identified by ASTHO, which 

included IPRs, AAR, other H1N1 evaluations, reports and articles, and recent pandemic preparedness 
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Association of State and Territorial Health Officials Page 14 

assessments. The environmental scan was not intended to be a comprehensive review or a literature 

review of all materials evaluating H1N1 response efforts. Priority was given to IPRs, AARs, and other 

evaluations by agencies and organizations involved in preparing for and responding to the outbreak. As 

such, the scan focused primarily on federal, state and local governmental, non-governmental organization, 

and academic center resources. Elements from these sources were organized according to the list of 

categories identified previously in Table 1. 

Data from the scan was combined with the survey and state H1N1 response review meeting findings to 

develop the consolidated group of barriers discussed in Section III, “Compilation of Barriers Identified” 

of this report. 

The full text of the Environmental Scan of H1N1 Reviews and After-Action Reports: Identifying Policy 

and Legal Issues report is contained in Appendix 4. 

I.D Advisory Review Panel Meeting 

The final element of the ASTHO H1N1 barriers project was to convene an advisory panel of selected 

state and territorial health agency staff to discuss the barriers identified in the project, designate priority 

barriers for action, and make recommendations for addressing the priority barriers. 

The advisory review panel met in ASTHO’s offices on May 25, 2010. The approximately 25 participants 

included representatives from nine state health agencies (including the five states that held H1N1 

response review meetings) and CDC, as well as staff from ASTHO, NACCHO, and ASTHO’s consultant, 

Logan Circle Policy Group. The meeting agenda and attendees list are contained in Appendix 1. 

The priorities and recommendations generated from the H1N1 Policy Barriers Advisory Review Panel 

meeting are contained in Section II, “Overview of Barriers and Priorities for Action” of this report. 

   
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II. Overview of Barriers and Priorities for Action 

Section II section provides a brief overview of the major policy barriers identified through the ASTHO 

H1N1 Policy Barriers Project. More importantly, this section identifies the priority policy barriers that the 

project’s Advisory Review Panel determined should be addressed immediately to enhance the public 

health systems’ response for future events. 

II.A Overview of Policy Barriers 

ASTHO received input from state and territorial health agencies about hundreds of H1N1 policy barriers 

through the various mechanisms of the H1N1 Policy Barriers Project. The identified barriers, mitigation 

strategies and suggested recommendations are compiled in detail in Section III “Compilation of Policy 

Barriers.” Section II.A highlights the major policy barriers identified in the each of the following seven 

categories, which categories were used throughout the project: (A) ICS, Command and Control, and 

Authority; (B) Surveillance, Epidemiology, and Laboratory Services; (C) Medical Care and 

Countermeasures; (D) National Vaccination Campaign; (E) Workforce, Capacity, and Infrastructure; (F) 

Federal/State/Local Coordination; and (G) Communications. The items in this section are not presented in 

any priority order. 

ICS, Command and Control, and Authority 

States found that more consistent use of a unified command structure during the H1N1 outbreak would 

have benefited the response at all levels of government. Inconsistent use of a formal incident command 

system (ICS) by some states was tied to the absence of state emergency declarations in some instances. 

Participants in the Policy Barriers Project noted that federal and state officials need to provide more 

information to the public and stakeholders about the processes and implications of various emergency 

declarations (e.g., Stafford Act, Public Readiness and Emergency Preparedness Act, state emergency 

laws). 

Federal and state emergency declarations trigger a range of emergency response powers, liability 

protections, as well as waive various statutory and regulatory requirements. States identified several 

issues related to emergency powers and waivers. Specifically, federal and state legal counsel need to 

understand the scope of statutory and regulatory waivers allowed under current federal and state 

emergency declarations and evaluate other areas in which waivers could be used to enhance future 

response efforts. Additional guidance and outreach is also needed about the application and implications 

of the Public Readiness and Emergency Preparedness (PREP) Act. Finally, states noted ongoing concerns 

held by public and private sector participants and volunteers about their potential legal liabilities during 

the H1N1 response. 

States also frequently identified barriers related to school closure and other community mitigation 

measures. Changes in school closure guidance and triggers for implementing closure caused confusion, 

were at odds with how communities were experiencing the outbreak, and created gaps in services to 

children. Other community mitigation strategies to control the spread of H1N1 needed greater attention 

during the response.
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Surveillance, Epidemiology, and Laboratory Services 

States frequently identified the need for more consistency nationally regarding surveillance strategies, 

data collection and analysis. States also noted that inconsistent case reporting methods nationally led to 

differing case counts, conflicting messaging, and challenges dealing with the media and public about 

reported cases. States found it challenging to balance the need to provide case information while 

preserving individuals’ privacy, especially when discussing the outbreak at the local level. 

States uniformly identified strained public health laboratory capacities at the federal and state levels as a 

significant issue during H1N1. Timing limitations imposed on state laboratory-related expenditures in the 

Public Health Emergency Response (PHER) grant further hindered laboratory capacity during the H1N1 

response. State and federal public health laboratories need sustained federal funding. 

Medical Care and Countermeasures 

States identified a range of policy barriers related to medical care and countermeasures. Overall, states 

found that gaps in information and federal and state approval processes for guidance on medical care and 

countermeasures impacted the timely distribution and utility of these guidances during the H1N1 

response. 

States had difficulty assessing the status and location of supplies of medical countermeasures because of 

limits on the states’ ability to access information about private supply chains. Regarding the federal 

Strategic National Stockpile (SNS), states found that the lack of closer federal-state consultations about 

the types of SNS assets distributed to states hindered the effectiveness of those assets during the response. 

States also identified ongoing questions about the ownership status of surplus medical countermeasures 

distributed from the SNS, which left states unable to deploy and use these materials quickly. Delays and 

conflicts in federal guidance on respiratory protection (N95s) led to confusion, caused shortages in 

supplies, and delayed their release of state and local stockpiles. 

States expressed several concerns about administering countermeasures, including uncertainties about 

dispensing countermeasures to federal employee populations, fees for dispensing countermeasures, and 

the use of federal stockpile antivirals for prophylaxis. States also noted that data elements and systems 

necessary to assess the use and potential adverse effects of federal countermeasures stockpiles must be 

better defined, especially for determining if countermeasures are being equitably distributed to vulnerable 

populations. States expressed concerns over confusion and impending costs for recovering and disposing 

of expired and surplus countermeasures. 

Regarding emergency use authorizations (EUAs), states encountered health care providers who were 

uncertain about the safety and legality of using EUA products and were therefore resistant to offer them 

to patients. States also expressed concerns that information supplied to patients with EUA products may 

not ensure that informed consent is obtained. 

Finally, states noted that alterations in the process, scope and frequency of reporting for the National 

Hospital Available Beds for Emergencies and Disasters (HAvBED) by the U.S. Department of Health and 

Human Services (HHS) caused frustration and confusion among states, hospitals and vendors. HHS’s 

request for direct reports from hospitals disregarded established reporting systems going from hospitals 

through the states to HHS. 
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Association of State and Territorial Health Officials Page 17 

National Vaccination Campaign 

States acknowledged the tremendous efforts of the federal government to develop the H1N1 vaccine in a 

short time, especially given the nation’s current vaccine production technology. Because the H1N1 

vaccine figured so prominently in the response, states identified a number of significant issues arising 

from the national vaccination campaign. States uniformly concluded that delays in vaccine production and 

changing messages about its availability caused confusion for the public and damaged the credibility of 

governmental public health at all levels. Initial vaccine delays resulted in the postponement of vaccination 

clinics and the inability to capitalize on public demand for the vaccine. States also acknowledged that 

differing strategies used by states and localities for vaccinating priority groups and the general public 

caused some confusion.

Regarding vaccine ordering and distribution, states observed that vaccine ordering systems were too 

complex and did not provide useful ways to manage ordering and delivery information. Requirements for 

ordering vaccines in 100 dose-count minimums necessitated that states engage in additional distribution 

activities and further delayed delivery of vaccines to providers and localities. Some states indicated that 

requiring centralized state distribution systems for H1N1 vaccines ran counter to some states’ existing 

immunization systems causing confusion and delay with providers and localities. 

School-based vaccination clinics, though an effective strategy to reach target populations, were limited by 

decentralized legal/policy authorities among education and health officials at the local level. States 

reported employing various strategies to expand the pool of eligible vaccinators, but state statutory 

limitations and a generalized fear of liability persisted among potential vaccinators. States also found that 

payment and reimbursement issues and systems for H1N1 vaccine administrations costs were slow to be 

addressed and must be improved. 

States encountered problems tracking H1N1 vaccines administered if the state did not require mandatory 

reporting of vaccinations through state immunization registries. States also reported ongoing questions 

and limitations on receiving reports of vaccinations administered in school-based clinics. Overall, states 

concluded that better systems are needed for tracking vaccine uptake, coverage, recall and adverse events. 

Finally, states expressed confusion and concerns over the impending costs of recovering and disposing of 

expired H1N1 vaccine. 

Workforce, Capacity, and Infrastructure 

Flexing the public health workforce was a challenge, especially as repeated rounds of budget cuts and 

hiring freezes have shrunk standing capacity in state health agencies. States acknowledged that PHER 

grants were vital in allowing states to enhance their public health surge capacity. States observed that 

surge capacity in the health care sector remains limited and could be quickly overwhelmed during a 

prolonged pandemic event. While volunteers provided important surge capacity during the H1N1 

response, they were not appropriate for all public health positions in a response. States also encountered 

issues dealing with volunteers’ continuing fears about their potential legal liabilities for participating in 

H1N1 response activities. 

States noted several issues pertaining to employer policies and work place protections. States observed 

that public health recommendations were not universally supported by employers’ sick/administrative 

leave policies. Workers, who feared losing their wages or jobs, may not have complied with public health 

recommendations to stay home when sick. States also encountered ongoing questions and concerns about 

mandating vaccination for health care and other workers. 
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Federal/State/Local Coordination 

States found that coordination between and among federal, state, and local governmental entities was, at 

times, inconsistent over the course of the H1N1 response. Some linked poor coordination with the lack of 

a clear unified command structure through which to work on a combined federal, state and local response. 

PHER grants provided states with the resources necessary to mount H1N1 response activities, but 

requirements for managing the grants were cumbersome and time-consuming. Federal grant and 

cooperative agreement requirements generally did not allow the states’ enough flexibility to surge 

personnel and resources in mounting H1N1 response activities. Some state governmental policies and 

procedures, as well as the internal operations of state agencies, tended to delay the rapid deployment of 

funds and personnel designated for pandemic response activities. 

States frequently noted that as the less virulent nature of H1N1 became apparent, response plans based on 

worst-case scenarios were not appropriate for this outbreak. Prior pandemic influenza planning has been 

geared toward a worst-case scenario but must become more flexible and scalable to allow for pandemics 

of less virulent influenza viruses. 

Communication 

States noted that federal, state and local governments need to achieve and maintain more consistent 

communications practices and messaging during emergency responses. Inconsistent and slow federal 

messaging and ad campaigns complicated state and local efforts to communicate about H1N1 response 

activities. Delayed federal decision-making and inconsistent messaging about the severity of the H1N1 

outbreak created significant public and media outreach demands on the states. 

States also observed that federal, state and local agencies did not consistently and efficiently 

communicate with stakeholders, especially health care providers. Governments at all levels needed to 

develop and use more effective strategies to reach minority communities and special and vulnerable 

populations during the H1N1 outbreak. 

II.B Policy Barriers Requiring Priority Action 

This section lists in order the priority barriers identified for action by the ASTHO H1N1 Policy Barriers 

Project Advisory Review Panel. For each of the following nine priority items, the policy barrier is 

identified and discussed and recommendations for addressing the barrier are suggested. 

1. More consistent use of a unified command structure during the H1N1 outbreak would 

have benefited the response at all levels of government. 

Federal, state and local governments did not consistently operate under a unified command structure or an 

incident command system (ICS) during the H1N1 outbreak. The lack of coordinated command structures 

led to problems with communication and coordination, and ultimately hindered the collective 

governmental response to H1N1. All levels of government need to adopt and consistently use common 

operating protocols and terminology across all levels of government during an emergency response. 

At the federal level, it was unclear during the H1N1 response if federal agencies were operating under a 

unified command structure. This gave rise to a perception among states of fragmented federal decision 

making, inconsistent messaging, and the issuing of conflicting guidance. States also received input and 
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Association of State and Territorial Health Officials Page 19 

requests from multiple federal agencies, which caused confusion for state and local governments and 

required duplication of efforts to satisfy inquiries and manage the confused public. 

States’ use of unified command structures or ICS varied as well. States identified whether or not a state 

emergency was declared as a factor contributing to the inconsistent use of command structures. States 

encountered difficulties with staffing 

ICS roles due to the prolonged H1N1 

response and lack of staffing depth in 

key positions. 

At the local level, the states saw that 

local governments use’ of a unified 

command during the H1N1 response 

was mixed. Advisory Panel participants 

remarked that some local governments 

used unified command more 

consistently than did some of their state 

counterparts; localities in these states 

were concerned with the apparent lack 

of an ICS/unified command at the state 

level. 

Recommendations 

Overall 

 A careful review should be 

conducted to evaluate how 

implementing a clear UCS/ICS 

structure could have improved the 

H1N1 response at all levels. 

 Reinforce the importance that all 

levels of government routinely train 

and exercise UCS/ICS plans as per 

the National Incident Management 

System (NIMS). 

 Federal, state and local 

governments should explore options for alternative unified command structures (UCS)/ICS to be 

implemented during prolonged emergencies such as a pandemic. This may be especially necessary for 

state and local governments in which lack of staffing depth may hinder full implementation of 

UCS/ICS plans. 

 The states and the federal government should explore using vehicles such as grants and cooperative 

agreements as mechanisms to reinforce the expected use of UCS/ICS during a response. 

 Federal programmatic funding should cover the time that state and local personnel who are supported 

by federal grants are deployed to the UCS/ICS and response activities during a declared national 

emergency. 

Policy Barriers Requiring Priority Action 

1. More consistent use of a unified command structure 

during the H1N1 outbreak would have benefited the 

response at all levels of government. 

2. Delays in vaccine production and changing messages 

about its availability caused confusion for the public and 

damaged the credibility of governmental public health at 

all levels. 

3. More consistency is needed nationally regarding 

surveillance strategies, data collection and analysis. 

4. Federal stockpiling decisions affected state and local 

response activities and influenced the supply chain of key 

medical countermeasures. 

5. Delays and conflicts in federal guidance on respiratory 

protection (N95) led to confusion, caused shortages in 

supplies, and delayed the release of state and local 

stockpiles. 

6. Public Health Emergency Response (PHER) grants 

provided states with the resources necessary to mount 

H1N1 response activities but the format and requirements 

for managing the grants were time consuming and 

somewhat cumbersome. 

7. The H1N1 response strained public health laboratory 

capacity at the federal and state levels. 

8. Flexing the public health workforce was a challenge 

especially given restrictions on federally-funded positions 

at the state and local levels. 

9. Federal, state and local health agencies need to use new 

and more effective strategies to reach special and 
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Federal 

 Define clear roles for each federal agency involved in the response, clearly communicate these roles 

to all federal, state, and local government partners, and respect these roles during an event. 

 Coordinate planning and messaging from the federal government to different populations served by 

different federal, state and local agencies. 

 Build a transparent, coordinated process for identifying information that federal agencies want states 

and localities to monitor and coordinate to avoid confusing, conflicting messages from multiple 

federal agencies. 

 Ensure that there are robust procedures for informing and preparing new federal staff at all levels on 

current emergency response plans, available critical resources, and protocols for working with state 

and local governments during an emergency. 

State and Local 

 State and local governments must consistently train health agency staff on the use of UCS/ICS and 

regularly practice use of these response structures though exercises. 

 States and localities should develop policies that allow for activation of a joint incident command 

early in an event even if other parts of the state’s emergency management response are not activated. 

 If UCS/ICS is used, all levels of the state health agency should comply with the response structure 

and process requests through specified channels. 

 There must be laboratory and epidemiology staff within the response structure to provide insights into 

attack rates and monitor laboratory testing capacity and results. This is especially true when there is 

an outbreak of a novel virus, as in the case of the H1N1 outbreak. 

2. Delays in vaccine production and changing messages about its availability caused 

confusion for the public and damaged the credibility of governmental public health at 

all levels. 

States recognized that the federal government did an admirable job in quickly isolating the H1N1 virus, 

developing and testing vaccine, and getting it into large-scale production. States also understood that the 

federal government was limited in its ability to affect vaccine production capabilities, especially given the 

nation’s current vaccine production technology. For better or worse, vaccine issues became the definitive 

aspect of the H1N1 response. States concluded that dealing with slow and variable vaccine delivery from 

manufacturers and the shifting messages about vaccine availability overshadowed all of their other 

response activities, which were many. 

Advisory Panel participants identified public messaging about the vaccine as highlighting the central 

challenge for governments at all levels during the H1N1 response—balancing the desire to rapidly 

provide information to the public with the need to ensure the information is accurate. Federal efforts to 

demonstrate a quick public health response to H1N1 resulted in accelerating the estimated arrival date for 

vaccine, which raised the public’s expectations about its availability. When the vaccine production did not 

meet the announced availability date, this was seen as a delay by the public. Small and uneven initial 

delivery of vaccine further exacerbated perceptions of delay and governmental mismanagement. 

Initial vaccine delays resulted in the postponement or cancellation of state and local H1N1 vaccination 

clinics. More significantly, vaccine delays caused governments to fail in capitalizing on the public’s 

interest in vaccination when demand was at its highest. States perceived that the overall handling of 
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vaccine issues hurt the credibility of governmental public health with providers and the public. Advisory 

Panel participants also concluded that federal vaccine messaging difficulties related back to the lack of 

clear a UCS/ICS at federal level. 

Recommendations 

 One federal entity should be in charge of communicating vaccine supply information. 

 The federal government should be cautious in making projections rather than causing unrealistic 

expectations from optimistic estimates. 

 The federal government should postpone public communications about vaccine availability until 

sufficient supplies are available to engage in meaningful vaccination activity. Vaccine distribution on 

the mid-October target would have eliminated many of the problems experienced with the October 1 

release announcement.

 Federal, state and local agencies need to improve their ability to plan, organize, and communicate 

when production and delivery of the essential piece of the response strategy (i.e., sufficient vaccine) 

is outside of governmental control. 

 The federal government should have a greater role in monitoring the development and production of 

vaccine, especially when manufacturers are creating vaccine to combat a novel virus like H1N1. 

 The U.S. needs to approve vaccine manufacturing technology improvements to more quickly produce 

vaccines. Until technology fixes are addressed, federal agencies need to improve their communication 

strategies and present realistic representations of vaccine availability to the public. 

 Sufficient supplies of vaccine should be ready for distribution when a national vaccination campaign 

effort is launched. 

 Vaccination should not be the only focus of pandemic response activities. It is equally important to 

stress personal infection control measures (e.g., hand washing) and community mitigation measures, 

too. 

 Anti-vaccination messages should be expected and messages countering anti-vaccination sentiments 

should be proactively developed and deployed.

3. More consistency is needed nationally regarding surveillance strategies, data 

collection and analysis. 

Advisory Panel participants uniformly affirmed that surveillance data is the foundation of the public 

health system and upon which public health emergency response decision-making is based. States 

commented on disparities in the types and amounts of data collected at different levels of government and 

among jurisdictions. These disparities made it more difficult to make good decisions during the H1N1 

response and to give meaningful reports of the outbreak’s spread and patterns. 

Recommendations 

 Federal, state and local governments should conduct a joint evaluation of epidemiologic and 

surveillance systems used during the H1N1 response to determine what worked well and what should 

be improved. As part of this process, it should be determined what data elements were necessary and 

eliminate that were not useful in order to streamline data acquisition and analysis during a public 

health emergency. 
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 Priorities for surveillance during a public health emergency need to be clarified. Top priorities for 

surveillance should be determining the severity of illness and identifying risk factors for infection 

because these data drive decision-making during a response. 

 Develop national standards for the use and reporting of data from syndromic surveillance systems. 

 Federal, state, and local governments and stakeholders should move toward greater nationwide 

consistency in the reporting of data. 

4. Federal stockpiling decisions affected state and local response activities and 

influenced the supply chain of key medical countermeasures. 

Advisory Panel participants acknowledged that federal, state and local governments may have different 

views on the purposes and strategies for using Strategic National Stockpile (SNS) assets. Some states 

revealed challenges in trying to forward deploy SNS assets in preparation for H1N1 rather than waiting 

until the state was in a response posture. States voiced concerns that state and local needs and plans for 

using the stockpile did not align with perceived federal ideas about managing SNS inventory. 

Other states observed that there was a perception among some stakeholders during the H1N1 response 

that the federal government purchased mass quantities of medical supplies for the SNS, which caused a 

supply shortage leading to prolonged delays for health care facilities to obtain their standard supply of 

medical care items (i.e., sanitizer, surgical masks, N95 masks, bandages, syringes, etc.). States agreed that 

they need better information during emergencies about the status of medical countermeasures in private 

supply chains serving their jurisdictions in order to make decisions about the need for and targeting of 

SNS assets. 

Recommendations 

 Federal, state and local governments should evaluate the ways in which SNS assets were used during 

the H1N1 outbreak, as well as the ways in which states wanted to use SNS assets but were unable to 

do so because of policies or other response conditions. 

 Policies and procedures for states’ in requesting SNS assets should be evaluated and revised. The 

federal government needs to: (1) clearly define the data it needs from states when they request 

additional materials from the stockpile; (2) identify the timeline for receipt of order and response to 

the state; (3) maintain better communications with the states during the process to avoid duplication 

and to reduce the time between request and response; and, (4) make tools (such as a dashboard) 

available to SNS coordinators for managing stockpile assets. 

 Establish a federal-level system for monitoring stock levels and locations of key medical 

countermeasures (e.g., antivirals, antibiotics, masks, etc.) in private supply chains during a declared 

national emergency. This information should be available to state and/or local health officials on at 

least regional level so public health leaders can be advised of supply chain capacity and make more 

informed decisions about deploying state/federal stockpiles. 

 To the extent possible, the federal government should purchase material for the SNS in advance of an 

emergency. Large scale federal purchases in the midst of a public health emergency can severely limit 

the national supply chain for all purchasers. Private sector just-in-time manufacturing practices can 

further exacerbate shortages of medical countermeasures during national public health emergencies. 
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5. Delays and conflicts in federal guidance on respiratory protection (N95) led to 

confusion, caused shortages in supplies, and delayed the release of state and local 

stockpiles. 

There were conflicting opinions as to the level of personal protective equipment (PPE) required for health 

care workers (i.e., N95 respirators or surgical mask) during the H1N1 response. States cited a range of 

potential guidances from the CDC, the Occupational Safety and Health Administration (OSHA), the 

National Institute for Occupational Safety and Health (NIOSH), the Institute of Medicine (IOM), state 

health and occupational agencies, and even some from local health agencies. Some states issued their own 

guidance addressing the N95 respirator issue while other states followed CDC guidance or were not 

comfortable issuing their own recommendations. 

The range of guidances and their accompanying conflicts and inconsistencies left health care and other 

affected organizations wondering which one(s) to follow. States observed that conflicts among CDC, 

OSHA and state health and occupational directives/guidances on N95 respirators raised particular 

concerns among health care facilities about potential enforcement and other liabilities. 

The requirement to use N95 respirators for H1N1 resulted in supply shortages and required extra time and 

resources by health care facilities, especially those using N95s supplied from the SNS. States experienced 

significant challenges with the N95 supply chain throughout the pandemic response. State and local 

health agencies did not know what brands of N95 were in the stockpile and what mix of sizes and brands 

would be delivered to them for use by facilities in their jurisdictions. Often the N95s from the SNS did 

not match the brands regularly used by the receiving health care facilities, thereby necessitating additional 

fit testing activities by recipients. 

Recommendations 

Overall 

 Federal agencies should coordinate in advance of an event to create timely decision-making protocols 

and identify realistic rules that will be instituted in an emergency situation, whether it is a mild 

communicable disease or something more severe. 

 Federal, state and local governments need to clarify respiratory protection policies early. 

Governments should proactively consult with various stakeholders using PPE regarding polices on 

use and supply issues. 

 Once respiratory protection policies have been agreed on, governments should work with suppliers to 

ensure that necessary supplies of PPE are available to implement the guidance. 

Scientific Evidence for N95 Guidance 

 The federal government should re-examine the need for and most appropriate use of N95 respirators 

for H1N1 cases. 

 Infection control measures and recommendations about H1N1 from organizations such as the Society 

for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America 

(IDSA) and the Association for Professionals in Infection Control and Epidemiology (APIC) should 

be carefully considered. Once it was discovered that the H1N1 virus was transmitted similarly to 

seasonal influenza, infection control recommendations should have been adjusted to match those of 

seasonal influenza. 

 HHS and CDC should implement a more streamlined process to evaluate and respond to these types 

of technical issues during an outbreak event. 
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Association of State and Territorial Health Officials Page 24 

 Federal guidelines should be adjusted as new information and evidence becomes available. 

N95 Implementation Issues 

 Assuming that the scientific evidence continues to show that surgical masks are effective against 

transmission of influenza, new guidance should recommend their use, given that N95s are 

significantly more expensive. 

 CDC should issue policies, such as the N95 respirator guidance, earlier and take into account not only 

the available science, but also realistically consider the full range of practical/management 

implications involved in the process of providing health care for large numbers of individuals. 

 CDC should create a list of activities for which N95 respirators should be reserved, define criteria for 

states to use in determining and declaring a N95 shortage, and develop aids to assist in planning and 

estimating N95 respirators needed considering different priorities and situations. 

N95/PPE Supply Issues 

 State and local public health officials need better and timelier information about the supply chain for 

N95s/PPE. 

 CDC and the states need to define what is meant by a “shortage” of N95/PPE and its use as a trigger 

for releasing stockpiles and implementing protocols to deal with shortage conditions.

 Federal and state governments need to cooperate in proactively identifying the types of N95 and other 

PPE used by health care facilities. The CDC should survey the states to determine N95/PPE brands 

preferred by health care facilities in the states and stock these brands in federal stockpiles. 

Alternatively, the federal government should stock the SNS with various brands and sizes of 

N95/PPE so that correct supplies can be shipped to health care facilities and minimize the need for 

them to re-fit test employees to the SNS assets.

 The federal government should consider purchasing FDA-approved respirators for the stockpile 

without an expiration date so they would not need to be released under an emergency use 

authorization.

 There should be a central repository of N95s which is replenished for future events. Federal contracts 

with N95 and PPE manufacturers generally should be strengthened to prepare for supply chain 

disruptions during future public health emergencies.

Federal Guidance and Enforcement Questions 

 Definitive guidance from OSHA is necessary to resolve the current N95 issue and to address PPE 

issues that will arise in future public health emergencies. 

 The CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) should work with 

NIOSH and OSHA to clarify and resolve how CDC recommendations interact with OSHA safety 

requirements. OSHA should clarify how it will handle hospitals and other institutions that follow 

their states’ worker protection recommendations if those recommendations conflict with CDC 

recommendations. 

 States and health care facilities need a definitive understanding from the federal government about the 

status of CDC guidance as either non-compulsory (i.e., recommended action) or mandatory (i.e., 

required action) during an event, particularly when the agency’s guidance conflicts with other federal 

agencies’ guidances, policies or regulations. 
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Association of State and Territorial Health Officials Page 25 

 All federal agencies involved with determining PPE should coordinate and agree about guidances 

issued. It is especially necessary to include agencies with regulatory and/or enforcement authority 

(e.g., OSHA, EPA). 

6. Public Health Emergency Response (PHER) grants provided states with the resources 

necessary to mount H1N1 response activities but the format and requirements for 

managing the grants were time consuming and somewhat cumbersome. 

States readily acknowledged that the Public Health Emergency Response (PHER) grants provided states 

with the resources necessary to quickly mount H1N1 response activities, especially given the ongoing 

budgetary constraints of states and territories across the nation. States further agreed that prior federal 

investments in state and local public health and pandemic influenza preparedness established a vital 

foundation for a national response and identified pandemic planning as a national priority. 

With the H1N1 response, states found that CDC’s the cooperative agreement format used to deliver the 

PHER funds was challenging to manage while simultaneously responding to H1N1 outbreak. States 

found the need to submit multiple applications for the various phases of the grant and await CDC 

approvals to be time consuming and a hindrance to the states’ ability to respond appropriately to the 

event. The delivery of PHER monies in phases—with changing limitations on the use of funds in different 

phases—made it difficult for states to plan and manage their response activities. States observed that the 

PHER grants also highlighted the limitations of some states’ procurement and personnel systems/policies 

in their inability quickly utilize the funds. Advisory Panel participants agreed that states were able to 

successfully manage PHER application processes and direct multiple grant streams all while responding 

to H1N1 only because of their prior experiences handling Public Health Emergency Preparedness (PHEP) 

and Hospital Preparedness Program (HPP) grants and related cooperative agreements. 

States voiced significant ongoing concerns about the possibility that carryover will not be permitted for 

the PHER grants, thereby requiring states to use the funds by July 31, 2010. Health departments are still 

in the process of responding to H1N1. Recovery efforts and improvement plans will be taking place long 

after July 31, 2010. States believe this potential limitation on the use of PHER funds makes it very 

difficult to be good stewards of public funds should states need to expend the remaining funds before July 

31, 2010. 

Recommendations 

 PHER funds should be eligible for carryover the way PHEP funds are. 

 The application process needs to be simplified in the future. Funds should be awarded in one phase 

with more flexibility on their allowable uses in order to permit states’ to use funds to cover their 

unique response efforts. Awarding the funds in one phase would also streamline the purchasing and 

contracting processes at both the state and local levels. 

 Even if grant funds will be delivered in phases, the federal government should identify the total 

amount of funding to be provided to a state over the life of the grant. This will allow states to better 

plan for using the funds. 

 Identify more appropriate mechanisms for funding future response activities. The cooperative 

agreement process is better designed for funding long-term enhancement activities, not emergency 

response operations. 
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Association of State and Territorial Health Officials Page 26 

 CDC should work with states to formulate templates for "emergency" funding applications that still 

have elements of accountability, but do not take weeks to complete and can be quickly approved by 

CDC and its Procurement and Grants Office (PGO). 

 If application processes are required, reconsider using similar processes to those CDC used during the 

post 9/11 PHEP supplemental awards and pandemic influenza supplement in 2006. Specifically, use 

the methodology of releasing 20 percent of the funds, with authorization for use of the additional 80 

percent based on a comprehensive application submission. 

7. The H1N1 response strained public health laboratory capacity at the federal and state 

levels. 

Public health laboratory testing capacity was a concern at the state and federal levels during the H1N1 

response. For some states, laboratories were unable to keep pace with processing specimens which had a 

negative impact on surveillance activities, slowed states’ ability to correctly identify and describe the 

extent of the disease, and limited states’ support to local health departments. States also voiced concern 

over the capacity of the CDC laboratories to keep pace with the demands placed on it by H1N1. 

State procurement and contracting processes conflicted with the timeframes established by federal 

cooperative agreements, thereby delaying the purchasing of laboratory equipment and supplies, and hiring 

of laboratory and epidemiology personnel. PHER funds could not be expended for laboratory expenses 

after Phase 1 of the grant. States reported that most of the Phase 1 laboratory funds went to cover spring 

2009 costs; thereafter, states were unable to hire needed laboratory staff and were limited as to the types 

and amounts of supplies they could buy with other phases of the PHER funds. 

States also emphasized the need for sustained investments in laboratory capacity. Public health 

laboratories are a crucial component of the nation’s public health surveillance system that needs ongoing 

federal support. 

Recommendations 

Addressing Stressed Capacity 

 To alleviate extreme demands placed on the CDC laboratory during a national public health 

emergency, explore pre-staging laboratory activities in more than one laboratory in the country. 

 Develop better clinical guidelines and clinician education about which patients should be tested to 

reduce the burden on laboratories and target testing to public health needs. 

 Consider making CDC laboratory test kits available to at least a subset of trusted private partners to 

increase laboratory surge capacity and overall sentinel surveillance capacity. 

 Improve communication and cooperation with private laboratories. Both public and private 

laboratories are critical to a comprehensive understanding of the outbreak and a successful response. 

Sustaining Capacity 

 Provide more flexible funding guidelines to maximize and plan for workforce capacity issues as 

needed. Funding restrictions were a barrier to H1N1 response state public health laboratories. 

Although vaccination was a primary role for every state, laboratory testing and surveillance were 

critical to ongoing monitoring of H1N1 and funds should have been made readily available for these 

purposes. 
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Association of State and Territorial Health Officials Page 27 

 Secure sufficient and sustained federal funding to improve public health laboratory capacity to ensure 

more timely results and the ability to maintain a high level of testing as needed. 

 More research is needed to produce national standards (e.g., case definition, which other elements 

should be reported) for syndromic surveillance. Funding is needed for states to implement those 

standards with laboratory capability. 

 The federal government should fund and expand electronic reporting capabilities nationally.

8. Flexing the public health workforce was a challenge especially given restrictions on 

federally-funded positions at the state and local levels. 

States acknowledged that PHER funds helped tremendously in supplementing the states’ staffing needs as 

the overall state public health force was already greatly reduced at the beginning of the H1N1 outbreak. 

Even with PHER funds, however, states noted that because of the states’ fiscal crises, there was 

reluctance on the part of state personnel agencies to hire staff, even for a limited term. States responded 

by using temporary employees, but they required intensive training by staff already taxed with response 

activities. 

Some states observed that they did not have sufficient staff capacity to sustain activation of emergency 

operations centers (EOCs) for long periods of time. States had to pull staff from other public health 

agency programs beyond preparedness and immunization programs to staff the EOC. As a result, many 

other public health programs had to put their regular activities and responsibilities on hold or on reduced 

staffing levels. 

States faced continuing challenges in flexing and surging capacity using staff that is funded under other 

federal grants/cooperative agreements in areas not immediately involved with the H1N1 response. While 

there was limited ability to flex federal funding, Advisory Panel participants observed that states faced 

obstacles in trying to adequately staff H1N1 response activities while maintaining activities on other 

federally funded projects and meeting state-matching requirements on those grants. States also recognized 

that the lack of sustained funding to support the overall public health infrastructure would have severely 

limited the nation’s capacity to respond to H1N1 absent supplemental federal funding. 

Recommendations 

 The federal funding process should allow federal agencies to advance a portion of emergency grant 

funds to state and local governments so they can initiate response activities immediately. Having to 

await the full application and review process delayed initial response activities. 

 HHS and CDC should allow for staff in positions that are funded by any HHS or CDC program to 

assist in a public health emergency response as long as they are needed or while there is a federal 

emergency declaration in place. 

 Federal grants and cooperative agreement requirements and processes need to be more flexible during 

public health emergencies. 

 State health agencies should identify and routinely train and exercise more staff for various EOC/ICS 

positions. These staff should be provided with ongoing opportunities to remain engaged in state 

public health preparedness activities. This will improve states’ preparedness to respond to public 

health emergencies, but will require funding beyond what can be accomplished using current federal 

base preparedness funding. 
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Association of State and Territorial Health Officials Page 28 

 Federal, state and local governments need to rebuild the public health infrastructure during nonemergency times so that there is adequate staffing to rely on during a pandemic or other emergency 

event. 

 Federal and state public health officials should work to ensure that public health preparedness is 

recognized as a key component of the nation’s homeland security strategy, and is treated on par with 

federal and state funding for other national security response capabilities. 

9. Federal, state and local health agencies need to use new and more effective 

strategies to reach special and vulnerable populations and minority communities. 

States noted that state and local public health agencies were challenged in engaging members of special 

and vulnerable populations and other members of the public in vaccination efforts, particularly those in 

minority populations. Some observed that federal vaccine messaging to minority communities was 

conducted as a routine public health outreach campaign; however, more proactive measures were needed 

to identify potential areas of resistance and to construct messages to overcome areas of resistance. States 

commented that African-American and, to a lesser degree, Hispanic residents, expressed negative feelings 

or beliefs about the safety of the H1N1 vaccine. States learned that feelings of fear, anger and distrust 

about H1N1 vaccine among these communities also stemmed from a lack of confidence in state and 

federal governments generally. The inability to effectively reach minority and vulnerable populations 

resulted in decreased vaccination rates, delays in seeking vaccination, spread of misinformation, and 

ultimately disparate percentages of hospitalizations and deaths in minority patients with H1N1 compared 

to non-minorities. Advisory Panel participants agreed that governmental public health agencies need to 

engage in more successful partnerships with minority communities and develop more effective outreach 

tools for everyday use and during emergencies. 

Recommendations 

 Federal, state and local governments need to partner with stakeholders in minority communities and 

groups representing special and vulnerable populations to develop new and re-imagined outreach 

strategies to these populations. Priority should be given to identifying and addressing reasons for 

negative beliefs about the H1N1 vaccine and vaccination in general. 

 Follow well-established and proven risk communication strategies prior to launching public 

information and health education outreach campaigns for minority communities and 

special/vulnerable populations. 

 Federal, state, and local governments need to understand and address the sources of governmental 

mistrust held by various members of the public. 

 Governmental public health agencies must begin now to build more effective partnerships with 

minority communities for collaboration on ongoing outreach, as well as during emergencies. 

 The federal government should take the lead in routinely translating pandemic materials into multiple 

languages. 

II.C Analysis of Barriers and Other Issues 

The ASTHO H1N1 Policy Barriers Project identified significant policy barriers on a range of topics. 

Through discussions with the Advisory Review Panel and the various project elements (survey, meetings, 
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TABLE 2: KEY AND RECURRING ISSUES

Key Issues in the H1N1 Outbreak Recurring Issues in Public Health Emergencies 

Policy 

 PHER Grants 

 H1N1 Vaccine – Availability Messaging, 

Allocation Systems, 

 PPE – N95 – Guidance/Enforcement Issues 

 Pandemic Plans – Scalability; Relation to 

WHO Pandemic Stages 

 School Closure – Guidance; Impact on Other 

Services 

 Antiviral/Vaccine – Recovery/Disposal 

 Surveillance/Case Reporting – Federal v. 

State 

 Medical Supplies-HAvBED Direct Report to 

ASPR 

 Intergovernmental Coordination – No ICS 

 Employer/Employee Compliance with 

Guidance 

 Flexing Personnel and Funding 

 Public Health Surge and Infrastructure 

 Health Care Surge Capacity 

 Vaccine – Allocation; Distribution; Production 

Capacity 

 Laboratory/Epidemiology – Capacity; Electronic 

Surveillance Systems 

 State Procurement/Personnel Systems 

 Communication – Messaging Coordination; 

Outreach to Public and Stakeholders 

 Outreach to Special and Vulnerable 

Populations 

 Workforce Vaccination Mandate - Health Care 

Workers 

Legal 

 Emergency Declaration – PREP Act 

 Response with/without State Emergency 

Declaration 

 PREP Act – Scope/Liability Coverage 

 School/Public Health Issues – Scope of 

Authority 

 Vaccination – Expanding Authority to 

Vaccinate 

 Emergency Declarations – Scope/Implications 

 Volunteer Liability Concerns 

 Statutory/Regulatory Waivers 

 Coordination among Public Health Attorneys 

 Coordination of Legal and Policy 

Solutions/Personnel 

scan) it became evident that the national H1N1 response efforts highlighted challenges that emerged from 

the unique circumstances of the H1N1 outbreak, as well as revealed issues that seem to recur frequently in 

public health emergencies. The project also identified barriers that relate to underlying structural issues 

and outstanding public health preparedness issues that did not feature prominently during the H1N1 

response, but which likely would have been more significant had the H1N1 virus been more virulent. 

Issues “New” and “Old” 

The H1N1 outbreak featured “new” policy and legal issues—items that arose due to the circumstances of 

the H1N1 outbreak and response and that featured prominently in the states’ responses to the H1N1 the 

Policy Barriers Project. Examples of these issues include the dynamics of the N95 guidance, school 

closure guidance, and PREP Act questions. The H1N1 outbreak similarly highlighted “old” policy and 

legal issues—items that federal, state, and local public health officials have frequently identified dealing 

with in other public health emergency response activities. Examples of these items include the ability to 

flex and surge public health workers, concerns about laboratory capacity, and liability fears by staff and 

volunteers. Table 2 highlights some of the key H1N1 and recurring public health emergency issues. 

It is important to note that Table 2 certainly does not provide a comprehensive listing of all the H1N1 and 

recurring issues/barriers. More importantly, the characterization of issues as “old” or “new” is not 

intended to diminish the importance of an item. It is simply to demonstrate that unanticipated 

issues/barriers will arise with each public health emergency and that work remains to be done on other 

issues/barriers. The key issues identified for the H1N1 outbreak may occur again in future events. With 
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the recurring issues, governmental public health agencies need to anticipate that these types of issues are 

likely to arise with each response and work proactively between emergency events to alleviate these 

barriers if possible, or at least prepare strategies to address these challenges when they arise in future 

events. 

Relationships among Barriers 

Comments received from the Advisory Review Panel and the input of states throughout the project 

emphasized the relationships and connections among barriers. In any response, a decision made about one 

issue will cause both intended and unintended consequences in other areas. Several areas demonstrating 

these interactions are discussed below. 

Command, Coordination and Communication 

Advisory Panel participants found that the inconsistent use of some type of unified command structure by 

federal, state, and local governments was not only a central barrier to the H1N1 response, but also gave 

rise to other coordination and communication barriers. Participants cited several examples drawn from the 

compilation of identified barriers. (See Section III.) States indicated that more coordinated and consistent 

federal decision making could have reduced the barriers identified with communications about the 

availability of H1N1 vaccine. Better coordination regarding communication of vaccination priority groups 

and explaining differences in federal/state/local targeting of vaccine priority groups and the general 

population was needed at all levels of government. Panel participants further noted that the challenges 

governmental public health agencies encountered with vaccination among minority populations stemmed, 

in part, from poor communications and coordination. Delays in vaccine availability, which states believed 

hurt government’s credibility during the H1N1 response, only further exacerbated long-standing mistrust 

in government held by some in minority communities. 

States indicated that H1N1 clearly demonstrated the importance and impact of federal guidance on public 

health emergency response efforts. Advisory Panel participants highlighted issues with several federal 

guidances—N95, school closure, and pediatric antiviral formulations—as being emblematic of the 

challenges state and local governments faced when federal guidances were delayed and/or conflicted with 

other guidance or current laws/policies. Participants observed that some of the problems associated with 

these guidances could have been avoided, or lessened, had there been more effective coordination among 

federal agencies and better communication among federal, state, and local health agencies. 

Panel participants noted that command issues were affected in part by emergency declarations. Since 

emergency declarations at the federal and state levels trigger a range of enhanced authorities, liability 

protections, and statutory/regulatory waivers, these declarations impacted the H1N1 response. States 

commented that both public and private sector actors were at times uncertain about the implications of 

operating under an emergency declaration. It was also noted that not all states issued emergency 

declarations. Given the less virulent nature of the H1N1 virus, the outbreak did not qualify as a 

‘significant’ public health emergency under some states’ emergency laws, therefore, a state emergency 

could not be declared. One state indicated that it could not institute a state emergency unless there was a 

federal Stafford Act declaration; because the federal declaration was made under the National 

Emergencies Act, that state could not fully institute its emergency response activities. 

The practical and legal implications of operating without a state emergency declaration varied among the 

states. One state noted that it was still able to offer statutory and regulatory flexibility to health care 

facilities dealing with H1N1 response pressures under existing state health care licensing laws despite the 

absence of state emergency declaration. Another state noted that the absence of a state emergency 

declaration meant that emergency command structure led by the state’s emergency management agency 
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was not activated. However, this permitted the state health agency to remain the lead agency on the 

outbreak response, which was seen a preferable given that it was a public health emergency. Other states 

could not institute an ICS or EOC without a state emergency declaration. All of these issues demonstrated 

the command, coordination and communication challenges governments encountered related to 

emergency declarations. Advisory Panel participants discussed the need for governments to explore 

alternative command strategies that would permit a robust response to public health emergencies that may 

not be classified as emergencies under state laws. 

Legal Authorities and Liability Concerns 

States providing information to the H1N1 Policy Barriers Project frequently indicated that governmental 

personnel, stakeholders like health care providers, and volunteers were uncertain about the legal 

authorities and immunities granted under various federal and state emergency laws. There has been a 

proliferation of new emergency laws in the ensuing years since the September 11, 2001 World Trade 

Center attacks, which have helped to more clearly define governmental and public health authorities 

during emergencies and provide liability protections for a variety of actors necessary to mounting a robust 

response. With so many relatively new and untested emergency laws, states reported that both public and 

private sector personnel still have questions about the operations of these laws and how they interact. 

States most frequently identified questions about the PREP Act and its operation, coverage, and 

relationship with other federal and state laws. States also observed recurring challenges with 

understanding and communicating the requirements and processes for waivers under the federal 

Emergency Medical Treatment and Active Labor Act (EMTALA) and Section 1135 of the Social Security 

Act. 

States also noted significant perennial concerns on the part of public and private sector employees and 

volunteers about potential liability for their roles in H1N1 response activities. Although there are 

increasingly more robust federal and state legal protections for responders and volunteers, persistent 

liability concerns emerge during each new response and hinder efforts to quickly deploy surge personnel 

and volunteers. Liability concerns were cited in activities such as H1N1 vaccination clinics and the use of 

EUA products by health care providers. Other states noted efforts by some private health care providers to 

be included under a grant of state governmental immunity for administering H1N1 vaccinations—an 

expansion of state governmental immunity that gives pause to state legal counsel. Concerns about liability 

continue to overshadow public health preparedness and response activities. Project participants indicated 

that governments at all levels must redouble their efforts to educate all parties about available legal 

protections. 

Public Health Capacity and Funding 

Advisory Panel participants reiterated a sentiment held by all states: federal PHER grants provided vital 

funding to supplement public health workforce capacity, especially in key areas such as surveillance and 

immunization, during the H1N1 outbreak. Continuing budget crises in the majority of states has resulted 

in further diminution of state and local public health capacity. Federal funding for public health 

preparedness and emergency response activities will continue to be a priority. 

Structural Issues 

States’ responses and other sources reviewed for the H1N1 Policy Barriers Project revealed ongoing 

structural challenges that are affecting the nation’s capacity to respond to emergencies, as well as to 

engage in daily public health and health care activities. 
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Public Health Workforce and Infrastructure Capacity 

States uniformly acknowledged that lack of adequate and sustained funding to support public health 

infrastructure resulted in limited capacity to respond to H1N1 absent supplemental funding through the 

PHER grants. As a result of shrinking federal and state dollars, state and local health departments have 

cut back on core public health capacity, leaving them without the staff and resources required to mount a 

quick and coordinated response to an event such as H1N1. Advisory Panel participants observed, 

however, that short-term, supplemental dollars are not an adequate alternative to thoughtful, consistent 

funding geared toward building core capacity and ensuring the availability of a trained workforce and 

adequate laboratory surge capacity. 

Health Care System Capacity 

States indicated that the surge capacity of some health care systems (i.e., providers, hospitals, emergency 

departments, other health care facilities) was taxed during the H1N1 outbreak. Many observed that had 

the H1N1 outbreak been worse, health care operations would have been unable to keep pace with the 

demand for care. Like the public health sector, daily health care operations in many communities are 

operating on thin margins due to economic pressures. As a result, medical surge capacity is limited in 

many jurisdictions, presenting a challenge to mounting a community-wide response. The HHS HPP 

grants have provided some capacity enhancements, but states and hospitals agree that the funding levels 

to date have been insufficient to truly boost public health/health care medical surge capacity. 

Supply Chain Issues 

Throughout the H1N1 Policy Barriers Project, participating states detailed ongoing frustrations about 

their inability to more precisely identify the amounts and location of various countermeasures (e.g., 

vaccines, antivirals) and medical supplies in both public and private supply chains during the H1N1 

outbreak. States appreciate that such information, especially in regards to private supplies, is sensitive 

data. Advisory Panel participants observed that having more reliable and timely access to this information 

during emergencies would better allow public health officials to monitor supplies available to health care 

providers/facilities in their jurisdiction and coordinate the use of federal SNS assets. Participating states 

also expressed concerns about the ability of current just-in-time supply chains to handle a nationwide 

pandemic more severe than the H1N1 outbreak. 

Pending Issues 

Given the mild virulence of the H1N1 virus, the recent pandemic was not as severe as many were 

expecting should there have been an H5N1 pandemic, for instance. As a result, some facets of nation’s 

collective response did not come into play, but certainly would have if the H1N1 pandemic had been 

more severe. States identified the following issues as items still needing more attention by federal, state 

and local governments. 

Alternative/Crisis Standards of Care 

The public health and health care communities in all states have had ongoing discussions in recent years 

about the operational, legal and ethical considerations involved in providing medical care during 

emergencies. While different terms have been used to describe the concept (e.g., alternative, alternate, 

crisis, disaster or emergency standards of care), the concern is how should care decisions be made during 

an emergency when there may be inadequate staffing or supplies to provide the level of care that would 

be expected in a given community under ‘normal’ conditions. During the H1N1 response, some states 

characterized the initial limited availability of certain formulations of H1N1 vaccine as potentially setting 

up a circumstance in which altered standards of care should be activated. While states have initiated 

conversations about the topic in their jurisdictions, and many have developed robust strategies for 
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Association of State and Territorial Health Officials Page 33 

addressing alternative/crisis standards of care, the H1N1 outbreak provided states with salient examples 

with which to renew and update their dialogues about standards of care in emergencies. 

Alternate Care Sites 

Some state meeting participants identified a few barriers related to providing medical care at alternative 

sites to traditional hospital settings. While the use of alternate care sites did not feature prominently 

during the H1N1 response, the barriers that were identified about this issue during the recent pandemic 

are instructive. One state noted that staffing was the biggest barrier to alternate care site planning because 

hospitals did not want to divert their staff to off-site facilities. Another state noted that community health 

centers (CHCs) were limited in their ability to offer support to hospitals/clinics experiencing patient surge 

because CHCs cannot legally work outside their scope of practice (which are defined by assigned zip 

codes and populations) due to legal and insurance constraints. These issues demonstrate some of the 

operational, policy and legal barriers constraining use of alternate care sites. Governments at all levels 

should evaluate their experiences during H1N1 and the lessons learned regarding alternate care site 

planning and policy. 

Quarantine/Isolation and Travel Restrictions 

Issues relating to quarantine, isolation, and travel restrictions did not feature prominently in the feedback 

from states for the H1N1 Policy Barriers Project. This was in part because of the mild nature of the H1N1 

virus and that the disease emerged so quickly in the U.S. that travel restrictions would have been 

ineffective. Quarantine and isolation measures were primarily achieved through voluntary means and 

school closures. Again, the H1N1 outbreak provided public and private sector entities with the 

opportunity to implement and evaluate the effectiveness of various response strategies under less severe 

conditions. States frequently identified concerns with individuals’ willingness and/or ability to voluntary 

exclude themselves from work or school for prolonged periods of time. Employment-based 

sick/administrative leave policies may not be conducive to allowing persons to voluntarily 

isolate/quarantine themselves. Persons without paid sick leave may not have the economic ability to 

remain home when they are sick. Parents whose children’s schools have been closed due to an outbreak 

may not be able to leave work to stay home. All of these demonstrated the practical challenges that 

accompanied the public health measures and recommendations instituted to combat H1N1. These 

challenges must now be evaluated to determine how future pandemic response efforts will address them. 

Refining Pandemic Plans 

Advisory Panel participants and other states uniformly agreed that the H1N1 outbreak demonstrated the 

need for governments at all levels to reevaluate their pandemic response plans to make them more 

scalable to address outbreaks of varying degrees of severity. It was observed that U.S. pandemic planning 

to date has focused on worst-case scenarios like those envisioned should an H5N1 pandemic emerge. 

While this was a prudent approach to take for initial nationwide pandemic planning, these plans should 

now be refined to add more flexible and scalable elements. States also raised questions about whether 

U.S. is going to modify the HHS Pandemic Influenza Plan to reflect the 2009 World Health Organization 

(WHO) pandemic phases. Federal, state and local governments should closely coordinate in discussions 

about how these elements will be addressed in pandemic plans at all levels. 

   
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Association of State and Territorial Health Officials Page 34 

III. Compilation of Barriers Identified 

In Section III ASTHO combines information about the hundreds of H1N1 barriers identified through the 

survey, state H1N1 response review meetings and the environmental scan, and distills them into a set of 

issues that state and territorial health agencies encountered during the pandemic response. This 

information was provided to the H1N1 Barriers Project Advisory Panel to aid in their discussion and 

identification of the priority barriers for action in Section II. 

It is important to note that information and recommendations compiled in this Section III do not

necessarily represent ASTHO’s views, the official views of the states’, the consensus view of the 

public health practice community, or the suggestions of the H1N1 Barriers Project Advisory Panel 

presented in Section II. The information in this section presents the composite impressions collected 

from state agency and other personnel involved in H1N1 response and whose views were incorporated 

through the various mechanisms of this project and other H1N1 evaluations (e.g., IPRs, AARs, reports, 

etc.). 

While many aspects and nuances of the barriers are addressed in the information presented, the compiled 

data may not reflect every element of an issue as experienced by a specific state or may not have been 

experienced by every state in the same way. The goal was to present the range of barriers that states’ 

encountered by discussing various facets of the identified issues; relating different strategies employed by 

states to mitigate or “work around” barriers; and illustrate the range of suggested recommendations to 

address the barriers. The suggested recommendations presented in this section for any given barrier may 

or may not take a consistent approach to solving the barrier, and may or may not be reflected in the 

project recommendations for addressing the priority barriers identified in Section II. 

It is also important to note again that this project was not intended to be a typical after-action 

review in which successes and failures are evaluated. The focus of this project was to identify policy 

and legal barriers encountered in H1N1 response with the goal of removing or alleviating them in future 

public health emergency response activities. As such, the project did not actively seek out information 

about successful elements of the H1N1 response, which were many. To the extent that states’ provided 

information about H1N1 response successes this information has been summarized. 

The barriers are presented in the following categories, which were used throughout the project: (A) ICS, 

Command and Control, and Authority; (B) Surveillance, Epidemiology, and Laboratory Services; (C) 

Medical Care and Countermeasures; (D) National Vaccination Campaign; (E) Workforce, Capacity, and 

Infrastructure; (F) Federal/State/Local Coordination; and (G) Communications. 

Each barrier entry is presented in the following format: 

Issue: A statement of the barrier or barriers identified. 

Some barriers are presented as one comprehensive issue (e.g., N95 

respirators) under which various aspects of the barrier are examined (e.g., 

N95 conflicting guidance; supply shortages) 

Many other barriers are presented as a set of related issues (e.g., vaccine 
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Association of State and Territorial Health Officials Page 35 

availability, prioritization, and allocation) that reflects the frequent 

interdependencies among these issues as discussed by the states. 

Issue Type: Characterization as a policy issue or a legal issue (i.e., a policy issue that has 

legal implications). Where both elements apply, the primary characterization 

appears first (e.g., Legal; Policy) 

Level: Characterization as a state or federal issue. Where it applies to both levels, 

the primary characterization appears first (e.g., State; Federal). 

Discussion: Explication of the barrier and its various impacts on the H1N1 response. 

The information is quoted directly from the original source material (i.e., 

survey response, state meeting summary, IPR, AAR, etc.). 

Mitigation 

Strategies 

Employed: 

Listing of the solutions or “work-arounds” various states employed to 

address or overcome the barrier. 

The information is quoted directly from the original source material (i.e., 

survey response, state meeting summary, IPR, AAR, etc.). 

Recommendations 

Suggested: 

Listing of the various recommendations suggested by states to remove or 

improve the barrier. These do not represent the overall project 

recommendations. 

The information is quoted directly from the original source material (i.e., 

survey response, state meeting summary, IPR, AAR, etc.). 

[Sources: Survey: Meetings: Environmental Scan: ] 

   
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Association of State and Territorial Health Officials Page 36 

III.A ICS, Command and Control, and Authority 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified 

The primary barriers identified related to ICS, command and control, and authority issues were 

(numbering does not reflect a priority order for the barriers): 

A.1 H1N1 Response Command–All levels of governments could have made better use of 

the Incident Command System (ICS) than was done during the H1N1 outbreak. 

A.2 Emergency Declarations–Federal and state attorneys need to better understand and 

explain the implications of emergency declarations made under various statutory 

authorities. 

A.3 Emergency Declarations–Federal and state officials need to provide more information 

about the process and implications of emergency declarations to the public and 

stakeholders. 

A.4 Statutory and Regulatory Waivers–Federal and state legal counsel need to understand 

the scope of statutory/regulatory waivers allowed under current federal/state emergency 

declarations and evaluate other areas in which waivers could be used to enhance future 

response efforts. 

A.5 PREP Act–Additional guidance and outreach is needed about the application and 

implications of the Public Readiness and Emergency Preparedness (PREP) Act. 

A.6 General Liability Concerns–Participants in the H1N1 response expressed fears about 

their potential legal liabilities during the response. 

A.7 School and Daycare Closure–Changes in school closure guidance and triggers for 

implementing closure caused confusion, were at odds with how communities were 

experiencing the outbreak, and created gaps in services to children. 

A.8 Community Mitigation Measures–Other community mitigation strategies to control the 

spread of H1N1 needed greater attention.

Selected Successes/Mitigations Identified 

ICS, Command and Control, and Authority Generally 

 “The federal government provided states with recommendations for responding to the H1N1 

pandemic; these recommendations were developed as tools for the state to follow.” 

 “Although the state recognizes the federal government’s efforts in this regard, states had to develop 

guidance and policies specific to state conditions and authorities.” 
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Association of State and Territorial Health Officials Page 37 

 “Pre-existing legislation related to emergency powers for the state health director and liability 

protection for providers and businesses assisting with a disaster were utilized and allowed for 

efficient and effective use of resources.” 

 “The leadership and direction established by the Governor’s Office, as well as the development of a 

state H1N1 task force were successful in the command and control process.” 

Use of ICS/Unified Command Structure 

 “Excellent cooperation and collaboration between the local unified command and local mental health 

management agencies, local education agencies, local emergency management agencies, emergency 

medical services, hospitals, community partners, and the state’s public health coordinating center 

facilitated synchronized communication and response during the event.” 

 “Coordination between state and local authorities, decision to use a state emergency management 

team to facilitate distribution of medicine and supplies and competent staff were resources that 

worked well during the event.” 

 To address the perceived lack of unified federal command, one state health agency “delegated staff 

liaisons to all other state agencies and held regular meetings to assure that response activities among 

the various agencies were well coordinated.” 

Emergency Declarations 

 “Emergency declarations were critical in this process and PREP Act guidance from U.S. Department 

of Health and Human Services was readily available, as well as timely and understandable.” 

 States explained through the media “why the emergency declarations were being made, what they 

meant and why they were important in an attempt to lower public concern and anxiety and to 

maintain public confidence in local, state and federal government leadership.” 

PREP Act 

 “State agency counsel worked with the CDC Public Health Law Program and Office of General 

Counsel staff to get subsequent PREP Act declarations clarified so that all vaccinators authorized by 

state law would be covered.” 

General Liability Concerns 

 “Educated volunteers regarding the protections under the PREP Act to resolve concerns related to 

H1N1.” 

 “The state distributed summaries of the liability protections available under federal and state laws to 

local health agencies, providers and volunteers to help quell their liability fears.” 

Waivers 

 “The state health agency informed healthcare partners of the existing state licensing flexibilities in 

absence of a state emergency declaration.”

School Closure 

 “State and local public health departments coordinated with the state health agency to develop statespecific recommendations for school closure.” 

 “Schools worked closely with local health departments through daily communications regarding 

recommendations to close or remain open.” 
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Association of State and Territorial Health Officials Page 38 

 “Local health departments built upon relationships already developed with schools through earlier 

identification of POD sites or regular meetings, and by providing timely, accurate information about 

2009 H1N1.” 

 “Over the summer, many local public health departments were able to work with their school districts 

and colleges to implement policies and procedures for capturing ILI-related illness and surveillance 

data; unfortunately, not all school districts throughout the state were cooperative.” 

 “School surveillance activities will be continued in the state due to the success of H1N1 ILI schoolbased surveillance.” 

 One state health agency noted that it “established very strong relationships with education officials 

and had already been working on the school closure issue through a multidisciplinary school safety 

committee.” 

 “Through close communication and coordination, health and education officials were able to avoid 

major problems and effectively work through the few issues that did arise.” 

 Another state reported that, “once the epidemiology of the epidemic was better clarified, the eventual 

federal policy of not closing schools in most instances was more readily accepted.” 

Community Mitigation Generally 

 “The issuance of Quarantine and Isolation orders, as well as communication from state leadership was 

also key contributions in the early phases of the event.” 

Barriers/Recommendations Identified Detail 

H1N1 Response Command 

Issue: A.1 All levels of governments could have made better use of the 

Incident Command Structure (ICS) than was done during the 

H1N1 outbreak. 

Issue Type: Policy 

Level: Federal; State 

Discussion: Federal, state and local governments did not make consistent and/or full use 

of ICS during the H1N1 outbreak. 

Federal- Level Issues 

At the federal level, there was a lack of coordination and clear Incident 

Command and Control at the federal level. The White House, the U.S. 

Department of Homeland Security (and its agencies) and the U.S. 

Department of Health and Human Services (and its agencies) created 

confusion about who ultimately was in charge of the U.S. response to H1N1 

by not clearly and definitely implementing and announcing an Incident 

Command Structure. The various responding federal agencies had different 

lead spokespersons presenting sometimes differing messages. Additionally, 

federal agencies sometimes made overlapping requests to states using 

conflicting information-sharing distribution lists and protocols. DHS and 

HHS had their own (often conflicting) pandemic influenza plans. 
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Association of State and Territorial Health Officials Page 39 

State-Level Issues 

At the state level, respondents discussed inconsistent use of ICS or some 

other unified command structure during the H1N1 response. In some states, 

an ICS or emergency operations center (EOC) was not formally instituted 

because there was not a state emergency declaration for H1N1. Other states 

reported using modified ICS/unified command structures to compensate for 

challenges staffing and ICS/EOC during the prolonged H1N1 outbreak. 

Agencies’ policies regarding staff participation in the ICS needed to be 

implemented to that ensure response activities were appropriately and 

adequately staffed. Failure and/or delay to implement ICS postponed the 

mobilization of staff necessary to perform operational and support roles. 

In one state that had implemented ICS, “many people did not follow ICS.” 

As a result, the state’s immunization program staff received a “constant flow 

of numerous and redundant assignments and requests for information.” This 

dynamic taxed the capacity of program staff and distracted from important 

outbreak response activities. 

One survey respondent observed that “states that did not have a laboratory 

voice present in their ICS to counter public perceptions about the ready 

availability of and need for H1N1 confirmatory testing risked being 

swamped with samples from the ‘worried well’.” 

One state observed that ICS was used more reliably by local health 

departments in the state than it was at the state level: “Local health 

departments use ICS now, not only because it is federally mandated, but also 

because the system works. ICS is not a training issue, but a culture issue; it 

must be used for daily response, not just during large-scale outbreaks.” 

Mitigation 

Strategies 

Employed: 

 One state reported using CQI [continuous quality improvement] tools to 

“better define the process, roles and responsibilities in developing and 

maintaining the ICS and COOP [continuity of operations] list.” 

 To address the perceived lack of unified federal command, one state 

health agency “delegated staff liaisons to all other state agencies and 

held regular meetings to assure that response activities among the 

various agencies were well coordinated.” 

Recommendations 

Suggested: 

Federal-Level Issues 

Regarding the federal ICS response, “a careful review should be conducted 

to evaluate how implementing a clear ICS structure could have improved 

response at all levels.” Specific recommendations are to: 

 “Ensure federal agencies adhere to national incident management 

standards and collectively make appropriate policy decisions when 

guidance crosses into more than one federal agency.” 

 “Coordinate planning and messaging to different populations served by 
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Association of State and Territorial Health Officials Page 40 

different agencies.” 

 “Build in a clear process for information to be monitored and 

coordinated to avoid confusing, conflicting messages.” 

 “Develop robust procedures for informing and preparing new 

administrations and their key staff (at all levels) on current emergency 

response plans and available critical resources.” 

 “CDC needs to use ICS and make formal ICS positions and Incident 

Action Plans (IAPs) available to states for review.” 

State-Level Issues 

Regarding state ICS response, “agencies must implement procedures for 

maintenance of ICS and COOP lists in order to maintain their ICS capacity 

and visibility.” Other suggestions included: 

 “If the ICS is used, all levels of the state health agency—including upper 

management—need to respect the ICS structure and process requests 

through ICS channels.” 

 “There must be laboratory and epidemiology staff within the ICS 

structure to provide insights into attack rates and monitor laboratory 

testing capacity and results. This is especially true when there is an 

outbreak of a novel virus, as in the case of the H1N1 outbreak.” 

 “State health agency needs to implement ICS in a more formal way.” 

 “State should enhance programs such as WebEOC such that it is usable 

at the state and local level. Develop policies for its use.” 

 “More robust electronic communication conduit(s) to streamline 

communications outside of public health and communicate incident 

management.” 

 “States should develop policies that allow for activation of a joint 

incident command (JIC) early in the event, even if other parts of the 

state’s emergency management response are not activated.” 

 “Need to implement an established ICS for events that cross internal and 

external agencies (crossing county lines), staffing policies on the number 

of hours/shifts command staff can safely work during crisis before 

mandatory replacement is authorized, and initiating more ICS practice 

and exercises.” 

 “State/local governments should develop comprehensive policies for all 

state/local agencies for training and implementation of ICS.” 

[Sources: Survey: X Meetings: X Environmental Scan: ] 
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Association of State and Territorial Health Officials Page 41 

Emergency Declarations 

Issue: A.2 Federal and state attorneys need to better understand and explain 

the implications of emergency declarations made under various 

statutory authorities. 

Issue Type: Legal 

Level: Federal; State 

Discussion: Federal Issues 

Federal legal counsel need to clarify the implications of the various types of 

federal emergency declarations and what resources flow from the various 

declarations. The issuance of an H1N1 emergency declaration under the 

National Emergency Act as opposed to the Stafford Act required 

clarification as to the differences between the two types of emergencies, as 

well as how these declarations differ from the Secretary of HHS’s 

determination of a public health emergency. 

Even the specific wording of an emergency declaration can have significant 

implications. The President’s declaration of emergency under the National 

Emergency Act addressed Section 1135 waivers and specifically named 

Medicare, Medicaid, the Children’s Health Insurance Program (SCHIP) and 

the Health Insurance Portability and Accountability Act (HIPAA) as 

programs specifically eligible for waiver under the Act. However, EMTALA 

was not named in the Presidential declaration, although it was specifically 

named in the Secretary’s 1135 waiver granting CMS the authority to waive 

EMTALA penalties where indicated. The inconsistency between the 

wording of the two declarations left state agency counsel wondering if the 

omission in the Presidential declaration was intentional or an oversight. 

State Issues 

At the state level, some states’ statutory requirements for declaring an 

emergency are very narrowly proscribed, such that state emergency 

declarations were not made for the H1N1 outbreak. Because many 

extraordinary response measures are tied to the declaration of an emergency, 

state agency counsel are concerned that restrictive statutory requirements for 

declaring an emergency could delay or hinder a robust public health 

response. 

Mitigation 

Strategies 

Employed: 

None identified 

Recommendations 

Suggested: 

Federal Level 

 “Provide states with notifications regarding a pending Presidential 

Declaration to assist in incident action planning.” 

 “Need to resolve the missing reference to “EMTALA” in the President’s 
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Association of State and Territorial Health Officials Page 42 

Declaration of National Emergency.” 

 “The federal government needs to clarify the implications of alternative 

types of federal emergency declarations.” 

 “Federal government should develop clear guidelines for the federal use 

of emergency declarations to include Stafford Act and non-Stafford Act 

declarations. Educate state and local agencies on the authorities of these 

declarations.” 

 “Federal government should evaluate the similarities and differences 

between a Stafford Act declaration and the Public Health Emergency 

declaration with an eye toward benefitting the systems as a whole and 

avoid silos in funding and response.” 

 “Further clarification of details for tracking expenses in order to 

accurately apply for reimbursement in a disaster declaration is needed.” 

 “Develop and disseminate to state and local public health agencies a fact 

sheet that compares the implications of alternative federal emergency 

declarations, especially for the availability of financial and other 

resources they trigger.” 

State Level 

 “The state needs to implement more flexible disaster declarations to 

account for public health response.” 

 “Change current policies to enable the state department of emergency 

management to activate the state EOC and free up additional state/local 

resources without the Governor declaring an official state of 

emergency.” 

[Sources: Survey: Meetings: X Environmental Scan: X ] 

Issue: A.3 Federal and state officials need to provide more information about 

the process and implications of emergency declarations to the 

public and stakeholders. 

Issue Type: Legal; Policy 

Level: Federal; State 

Discussion: Explain the Implications of Emergency Declarations 

Federal and state officials need to demystify the emergency declaration 

process for the public, media and stakeholders. These audiences need to 

better understand the differences among various federal and state 

declarations, their purposes, and the effects of each (e.g., PREP Act, Stafford 

Act, state emergency declarations). 
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Association of State and Territorial Health Officials Page 43 

During the H1N1 outbreak, federal emergency declarations, which 

governmental personnel know serve as administrative triggers that allow the 

release of critical funding and other resources, were seen as confusing and 

potentially frightening to the public. When these declarations were 

announced during the pandemic, some respondents believed the declarations 

“made the situation sound much more severe and threatening than it actually 

was.” Some noted that “the emergency declarations were extremely hard to 

explain to the public, tended to heighten anxiety and fear, and put pressure 

on state governments to make the same declarations.” Still other states noted 

that “a presidential declaration prior to a state declaration resulted in a need 

for clarification of the declaration process for public health agencies and 

healthcare partners.” 

Implications of Operating with/without a State Emergency Declaration 

The real and perceived need for a state to issue an emergency declaration 

once a federal emergency declaration has been made depends on a state’s 

statutory and regulatory landscape. Some states have sufficient statutory and 

regulatory flexibility to allow for public health emergency response 

activities to occur even if there has not been a formal state declaration of 

emergency. One state noted, for example, that “the state health agency 

informed health care partners of the existing state licensing flexibilities in 

absence of a state declaration.” Another state noted that its statutory 

requirements for declaring an emergency are very narrowly proscribed, such 

that the H1N1 outbreak did not rise to a level meeting the requirements to 

issue a state emergency declaration. 

In some states, it is the state’s emergency management agency that is the 

statutorily-defined lead agency on emergency response activities. In these 

instances, the state emergency management agency “cannot stand up the 

state EOC until the Governor declares a state emergency. Thus, “a better 

process for activating the state EOC without an emergency declaration” is 

needed. 

Another state, which was operating under a state emergency declaration, 

remarked on the “lack of willingness of other state agencies to suspend rules 

(which the Governor’s declaration called for), which ultimately slowed 

response and wasted human resources.” It concluded that “if this had been a 

more severe pandemic, lack of administrative nimbleness could have been 

catastrophic.” 

A state representative also noted that “several counties received pressure 

from their partners to declare a local disaster to free up additional 

resources.” However, “as the case mortality rate was not unlike that of 

seasonal influenza, state and local health departments did not see the need to 

formally declare a state/local disaster.” 

Another state representative observed that: “Disaster declarations posed 

several state/local issues that made it apparent that public health 

emergencies should be classified differently. Public health emergencies tend 
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Association of State and Territorial Health Officials Page 44 

to emerge slowly and require a longer period of response. This is why it can 

be difficult to determine when to declare an emergency, establish ICS, etc. 

There needs to be a formal response that does not trigger the full disaster 

declaration, but addresses public health-specific issues.” 

Mitigation 

Strategies 

Employed: 

 States explained through the media “why the emergency declarations 

were being made, what they meant and why they were important in an 

attempt to lower public concern and anxiety and to maintain public 

confidence in local, state and federal government leadership.” 

Recommendations 

Suggested: 

Federal Level 

 “Provide states with notifications regarding a pending presidential 

declaration to assist in incident action planning.” 

 “Federal policies and laws need to be changed to allow for the release of 

assets under conditions or statements other than emergency 

declarations.” 

 “Declarations of emergency should be reserved for true emergencies 

when the public must be made aware of the situation’s severity and be 

prepared to take prudent action.” 

State Level 

 “The state needs to implement more flexible disaster declarations to 

account for public health response.” 

 “Change current policies to enable the state department of emergency 

management to activate the state EOC and free up additional state/local 

resources without the Governor declaring an official state of 

emergency.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Statutory and Regulatory Waivers 

Issue: A.4 Federal and state legal counsel need to understand the scope of 

statutory/regulatory waivers allowed under current federal/state 

emergency declarations and evaluate other areas in which waivers 

could be used to enhance future response efforts. 

Issue Type: Legal 

Level: Federal; State 

Discussion: At the federal level, clarification is needed as to the scope, process and 

implication of CMS waivers for Medicaid and EMTALA requirements 

during an emergency.
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Association of State and Territorial Health Officials Page 45 

States’ approaches to statutory/regulatory waivers vary according to their 

specific laws and approaches to managing emergency responses, as well as 

the structure of their public health systems (i.e., centralized, decentralized, 

etc.). Agencies must identify all of their states’ laws/policies that should be 

waived during the response. 

Mitigation 

Strategies 

Employed: 

None identified 

Recommendations 

Suggested: 

Federal Level 

 “CMS needs to adopt the use of a standard format for Medicaid waivers 

and that they are issued in a timely manner.” 

 “All regional HHS/CMS offices develop pre-drafted orders authorizing 

such waivers.” 

State Level 

 “State agency counsel need to share information about states’ 

approaches to statutory/regulatory waivers.” 

 “States’ counsels also need to examine alternative legal and policy 

approaches to expanding authority and improving response during 

public health emergencies.” 

[Sources: Survey: Meetings: Environmental Scan: X ] 

Public Readiness and Emergency Preparedness (PREP) Act 

Issue: A.5 Additional guidance and outreach is needed about the applications 

and implications of the Public Readiness and Emergency 

Preparedness (PREP) Act. 

Issue Type: Legal 

Level: Federal 

Discussion: State agencies and various stakeholders like health care providers and 

volunteers need more information and education about the PREP Act and its 

interplay with other emergency declarations; the contours of PREP Act 

coverage; and the extent of PREP Act liability coverage compared to other 

liability and compensation laws. More information is specifically needed 

about: (1) the relationship between PREP Act and state liability protections; 

(2) the extent of PREP Act liability coverage and scope of remedies 

available; and (3) the types of adverse incidents covered under the PREP 

Act. 
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Association of State and Territorial Health Officials Page 46 

Other specific PREP Act barriers identified by the states were: 

 The differences between activities covered under the PREP Act versus 

injuries covered under the Countermeasure Injury Compensation 

Program (CICP). The PREP Act appears to protect for more losses than 

the CICP pays for. It is thus possible that there will be no relief for 

certain claimants. As one respondent noted, “because CICP program 

administration and the types of injuries covered have not been 

determined yet, states are faced with questions they cannot answer.” 

 The interplay of the PREP Act, EUAs and off-label uses. Because the 

PREP Act does not cover off-label uses, CDC had to revise its 

recommendations for off-label use of H1N1 vaccines to extended 

populations (e.g., young children). A state respondent noted that “this 

omission in PREP Act coverage acted as a disincentive for providers to 

use valuable countermeasures when liability is not covered.” 

 The impact of PREP Act declaration language on those authorized to 

vaccinate. “The language of the PREP Act declarations for antivirals 

and the vaccine varied, causing uncertainty whether state emergency 

declarations (which can expand the persons qualified to act) were 

necessary– or would be effective–to procure PREP Act protection. 

Drafting issues with the first vaccine PREP Act declaration led to a 

narrower group of "qualified persons" than the authority granted by the 

PREP Act itself would have allowed. As a result, persons authorized by 

state law, but not licensed, to administer vaccines were initially 

uncovered by the H1N1 vaccine declaration.” 

Mitigation 

Strategies 

Employed: 

CICP issues: 

 “States have been directing inquiries to the CICP website, advising 

about the filing deadline, and acknowledging that CICP program 

administration practices are unknown.” 

Authorized vaccinators: 

 “State agency counsel worked with CDC Public Health Law Program 

and Office of General Counsel staff to get subsequent PREP Act 

declarations clarified so that all vaccinators authorized by state law 

would be covered.” 

Recommendations 

Suggested: 

CICP Issues 

 “Address the discrepancies, if any, between the PREP Act and CICP and 

finalize the CICP administrative rules and injury table.” 

Off-label Use

 “Amend the PREP Act to include liability coverage for off-label use.” 

Impact of PREP Act and Federal Laws Generally 

 “Implementation practices for emergency laws, rules, and acts should be 
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Association of State and Territorial Health Officials Page 47 

communicated to states from federal partners in weekly conference 

calls.” 

 “Federal partners should outline in writing the impact federal laws/rules 

will have on states.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

General Liability Concerns 

Issue: A.6 Participants in the H1N1 response expressed fears about their 

potential legal liabilities during the response. 

Issue Type: Legal 

Level: Federal; State 

Discussion: Despite an increasingly robust collection of federal and state laws addressing 

immunity, liability limits, and compensation for various participants in 

governmental emergency preparation and/or response activities, state and 

local health agency staffs, private providers and volunteers continue to voice 

concerns over the possibility of liability arising from their involvement in 

emergency response activities. 

 Assuring volunteers about liability protections: One state noted that “the 

lack of state liability protections initially hampered mobilization of 

volunteers to help coordinate and conduct mass vaccination activities.”

Medical Reserve Corps leaders reported that “the lack of state provisions 

ensuring liability protections for health care and other volunteers 

inhibited recruitment and made some reluctant to volunteer initially to 

help with H1N1 response activities.” “Protections provided through the 

federal PREP Act resolved the issue for the H1N1 response, but 

underscored the importance of ensuring adequate liability protections for 

volunteers.” 

 Indemnification of private health care providers: Another state noted 

that “private providers in that state sought indemnification that the state, 

as a sovereign, was not able to give.” “The hospital association and 

medical society asked the state department to provide indemnification in 

case they were sued for following triaging protocols recommended by a 

state/stakeholder group. State law limited the agency’s authority to 

provide the indemnification, plus there was concern over the ‘slippery 

slope’ of expanding that law (grant them ‘agent’ status) to cover those 

entities’ practices. While it remained a theoretical issue because the 

H1N1 outbreak was not severe enough, this potential barrier does 

expose the push-pull between public health needs and the need to limit 

the acts for which the state indemnifies.” 
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Association of State and Territorial Health Officials Page 48 

Mitigation 

Strategies 

Employed: 

 “The state distributed summaries of the liability protections available 

under federal and state laws to local health agencies, providers and 

volunteers to help quell their liability fears.” 

 “Educated volunteers regarding the protections under the PREP Act to 

resolve concerns related to H1N1.” 

 “The state health agency sent an explanatory letter as to why they 

refused to cover the hospitals and doctors in the above example.” 

Recommendations 

Suggested:  “State agencies need to better reach and educate providers’ and local 

health agencies’ legal counsel so they can assure their clients of the 

protections in place.” 

 “Renewed efforts are needed at the state and federal level to encourage 

states to enact comprehensive liability protections.” 

 “Have HHS consider PREP Act coverage for a wider range of responses 

that would include the actions of private providers acting under specified 

parameters.” 

 “Implementation practices for emergency laws, rules, and acts should be 

communicated to states from federal partners in weekly conference 

calls.” 

 “Federal partners should outline in writing the impact federal laws/rules 

will have on states.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

School and Daycare Closure 

Issue: A.7 Changes in school closure guidance and triggers for implementing 

closure caused confusion, were at odds with how communities were 

experiencing the outbreak, and created gaps in services to children. 

Issue Type: Policy; Legal 

Level: Federal; State 

Discussion: School Closure Guidance Issues 

There was confusion due to changing federal guidance/policies regarding 

school and daycare closures, especially early in the event, when some states 

were in the mitigation phase while others were still in the containment 

phase. As one respondent observed, “the public found it confusing that 

schools closed for H1N1, while there were similar numbers of cases of 

seasonal flu each year and schools did not close.” “Tying school dismissal 
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Association of State and Territorial Health Officials Page 49 

policies to the WHO’s pandemic phases became problematic when the 

pandemic did not develop as it potentially could have.” 

Another noted: “CDC was slow to adjust plans while state and local 

authorities resisted following the (then) current guidance. Fortunately, a lastminute reversal in federal guidance stopped the closures before they were to 

begin. However, the resulting confusion and lack of clear direction 

confounded state and local public health and school authorities and led to a 

loss of public confidence in the government’s ability to provide clear and 

meaningful direction.” 

Impacts of School Closures 

The full impact of implementing school and daycare closure policies must be 

assessed and planned for. Children enrolled in subsidized feeding programs 

(e.g., school breakfast, lunch and snack programs) were adversely affected 

by school closure. One state told of economic impacts: some schools had to 

close for financial reasons because parents were fearful of sending children 

to school in the fall, and school reimbursement is based on per capita 

attendance. Another state reported that it did not follow CDC school closure 

guidance because of the secondary effects doing so would have. 

Mitigation 

Strategies 

Employed: 

 One state health agency noted that it “established very strong 

relationships with education officials and had already been working on 

the school closure issue through a multidisciplinary school safety 

committee.” 

 “Through close communication and coordination, health and education 

officials were able to avoid major problems and effectively work 

through the few issues that did arise.” 

 Another state reported that, “once the epidemiology of the epidemic was 

better clarified, the eventual federal policy of not closing schools in most 

instances was more readily accepted.” 

 “Schools worked closely with local health departments regarding 

recommendations to close or remain open through daily 

communications.” 

 “Local health departments built upon relationships already developed 

with schools through earlier identification of POD sites or regular 

meetings, and by providing timely, accurate information about 2009 

H1N1.” 

Recommendations 

Suggested: 

General Recommendations 

 “Improve communication between state health and education agencies.” 

 “Strengthen/promote more widely the state health agency message to 

“keep your child home if sick” and infection control measures for 
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Association of State and Territorial Health Officials Page 50 

parents.” 

 “Recruit educator support of parental choices to keep child home, 

without requiring physician notes or other justification.” 

 “Coordinate and provide guidance from state health and education 

agencies in a timelier manner.” 

 “Work to provide consistent messages/communication between school 

districts within each county.” 

School Closure Guidance Issues 

 “Future federal school closure plans must be more nimble, guided by 

situational awareness, real-world input from state and local stakeholders, 

and be based on the best available scientific expertise.” 

 “Changes in state school policies which would allow for more flexibility 

in school funding during epidemics and pandemics.” 

 “Earlier and clearer school and daycare closure guidance from both the 

federal and state levels are needed.” 

 “It would have been helpful to have options/alternatives to provide to 

states (maybe a model) versus taking extreme action by shutting down 

schools.” 

 “School closure guidance needs to be reviewed and refined. There is a 

need to develop appropriate guidance to assist in both the community 

decision process and marketing strategies that: (1) identify the issues to 

consider; (2) recommend who should be involved in the discussions; (3) 

provide strong rationale why to keep schools open – “safe schools 

guidance;” and (4) provide recommendations for decision-making if 

closures are indicated.” 

 “Messages need to include reasoning for closing schools and not closing 

schools (e.g., the best place for well children is at school; the best place 

for sick children is at home).” 

 “Federal guidance should contain verbiage that states can develop 

alternate recommendations based on local conditions and authorities.” 

 “Conduct additional federal multi-agency meetings prior to developing 

guidance.” 

 “CDC school dismissal should address both preemptive and reactive 

dismissals (disease control measure versus operational/management 

issues) with better clarification and communication, as well as a clear 

understanding of the standards and trigger points for required control 

measures for state school/university closures.” 
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Association of State and Territorial Health Officials Page 51 

Impacts of School Closures 

 “Work with partners to review all policies creating obstacles (e.g., 

school funding, meals issues). Consider: (1) developing alternative 

solutions to deliver nutrition in a different way when schools closed; and 

(2) seeking federal funds to continue even if schools are closed during a 

public health crisis.” 

 “Federal, state and local governments should conduct forums for the 

development of consistent school closure policy and the continuation of 

services delivered through school administrations such as reduced cost 

meals and other social services.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Issue: A.8 Other community mitigation strategies to control the spread of 

H1N1 needed greater attention. 

Issue Type: Policy 

Level: State 

Discussion: States noted examples in which more could have been done to promote other 

community mitigation measures to limit/delay the spread of H1N1. 

Hospital Visitor Restriction Policies

“Hospital visitor restrictions varied from hospital to hospital. Hospitals 

wanted policies to be consistent and have recommendations from the state; 

restrictions were hard to enforce without state guidance. Child welfare issues 

were also an issue at some hospitals as some parents left their children 

unattended in waiting rooms if they were not allowed to visit patients.” 

State Workforce Travel Restrictions 

One state noted that “policies on travel restrictions (specifically air travel) 

for state employees during emergency events were strongly recommended 

for setting an example for others.” 

Mitigation 

Strategies 

Employed: 

None identified 

Recommendations 

Suggested: 

Hospital Visitor Restrictions 

 “Hospital visitor restrictions need to be more clearly communicated to 

the public as early as possible to ensure that children are left at home.” 

 “Hospital visitor restrictions should be consistent statewide; guidelines 

should be provided by the state health agency during future outbreaks.” 
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Association of State and Territorial Health Officials Page 52 

State Workforce Travel Restrictions 

 “Policies on travel restrictions (specifically air travel) for state/local 

employees during emergency events were strongly recommended setting 

an example for others.” 

 “State and local governments should develop human resource policies 

that protect the workforce and allow for setting an example to others 

regarding health policy programs.” 

[Sources: Survey: Meetings: X Environmental Scan: ] 

[This space intentionally left blank] 

 
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Association of State and Territorial Health Officials Page 53 

III.B Surveillance, Epidemiology, and Laboratory Services 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified 

The primary barriers identified related to surveillance, epidemiology, and laboratory services issues were 

(numbering does not reflect a priority order for the barriers): 

B.1 Surveillance, Data Collection and Analysis–There must be more consistency nationally 

regarding surveillance strategies, data collection and analysis. 

B.2 Reporting Estimated Cases, Deaths and Hospitalizations–Inconsistent case reporting 

methods led to differing case counts, conflicting messaging, and concerns about privacy. 

B.3 Laboratory Services Capacity–The H1N1 response strained the laboratory capacities at 

the federal and state level. States’ and laboratory capacities need sustained funding. 

Selected Successes/Mitigations Identified 

Surveillance Data Collection and Analysis 

 “Improvements were made to school absentee surveillance reporting systems and additional 

training/outreach to local health departments/schools, leading to a 240% increase in school 

participation rates.” 

 “Local health departments worked to share school closures/absentee rates throughout counties no 

matter which surveillance system was used.” 

 “The state’s epidemiology program provided weekly webinars, communications with hospital 

epidemiologists, and guidance on sample submissions in a timely manner.” 

 “The use of existing state surveillance systems, as well as the easy transitions from one system to 

another, assisted with successful disease surveillance; the CDC’s Influenza-Like Illness Network (ILI 

NET), the state epidemiologic tracking and collecting system, hospital-based epidemiologists, state 

public health laboratory, and the state medical assets tracking system were among the top 

surveillance.” 

 “A few states building on the CDC/APHL PHLIP [Public Health Laboratory Interoperability Project] 

pilot project were able to report electronically.” 

Reporting Cases 

 “Worked with reporting sources through the pandemic and eased some reporting requirements as 

local epidemiology warranted. It was difficult to balance partnership and reporting requirements.” 

Laboratory Capacity 

 “The state public health laboratory was successful in implementing a team approach to receive, 

process, test and report for H1N1 samples in a timely and efficient manner and provided the local 

health departments with regional surveillance reports.” 

 “The state public health laboratory utilized additional staff resources to handle laboratory surge.”
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Association of State and Territorial Health Officials Page 54 

 “Used epidemiology staff as a gatekeeper to prioritize testing samples to address the demands on 

public health laboratories.” 

 “Where possible, purchased equipment through state contract vendor. Other equipment purchases are 

being attempted through departmental processes.” 

Barriers/Recommendations Identified Detail 

Surveillance, Data Collection and Analysis 

Issue: B.1 There must be more consistency nationally regarding surveillance 

strategies, data collection and analysis. 

Issue Type: Policy 

Level: Federal and State 

Discussion: States identified the need for more consistency regarding surveillance 

strategies, data collection and analysis in several respects: 

Surveillance System Administration/Monitoring 

Dissemination of information between local, state and federal levels was 

seen as inconsistent. It was noted that “roles and responsibilities are not clear 

for each sector (i.e. local, state and federal) and the role of private testing for 

private providers must be clarified.” “Overall, a less labor intensive 

surveillance system needs to be established. Goals need to be determined 

and set as to how the surveillance system will be used. Questions about 

“who” will monitor and/or control the surveillance system needs to be 

determined, especially as more data sources are combined and data streams 

become more consistent and consolidated nationally.” 

Surveillance/Data Goals 

H1N1 surveillance goals and guidance need to be updated as the outbreak 

progresses (e.g., spring vs. fall 2009). Top priorities identified by states for 

surveillance were determining the severity of illness and risk factors for 

infection. “The current system does not capture or determine the severity of 

illness in real time. There is also the need to balance the tension between the 

immediacy of the situation versus the granularity of information. It will be a 

challenge to identify how best to refine surveillance systems to detect and 

capture the occurrences of considerable variability in disease, both 

geographically (e.g. neighborhood/community outbreaks) and within 

population groups (e.g. race/ethnicity).” 

Data Uniformity/Comparability 

Strong sentiment was expressed that there is a need for greater uniformity 

nationally among data collection and confirmatory laboratory testing 

procedures to strengthen H1N1 and overall response capacity. “State and 

federal health officials must determine how to reduce variability among 

surveillance systems to provide a clearer national picture.” A respondent 
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noted that the “lack of national standardized performance goals allowed 

extreme variation in confirmatory testing that was available for nationwide 

epidemiological comparison.” Further, “inconsistent utilization of 

confirmatory laboratory testing negatively impacted surveillance data 

comparisons between states.” 

Data Streams and Data Systems 

Data systems and protocols should build on and improve upon those used for 

seasonal influenza. “Alternate data sources and health information 

technology, such as syndromic surveillance and electronic health records 

systems, should be leveraged for better situational awareness.” Syndromic 

surveillance information proved useful; many jurisdictions used school 

absenteeism data to help enhance their understanding of influenza and 

support local decisions. 

Several states noted that “the lack of electronic laboratory data transmission 

(ELR) capacity at state and local levels hindered case reporting and data 

aggregation.” “This proved to be a significant barrier for laboratory and 

epidemiology units to coordinate and consolidate numbers across the state 

and country.” One specifically observed that the “Public Health Information 

Network (PHIN) recommends that labs must accept electronic requests and 

deliver reports as part of PHIN certification.” 

Confirmatory Testing 

States reported that “it was confusing in the early stages of the H1N1 

outbreak to have preliminary testing at the state, yet needing to wait for 

confirmatory testing by CDC.” One respondent observed that “shifting case 

definitions are probably unavoidable, especially early on, but causes 

problems for clinicians and the public.” 

Policy guidance is needed to validate clinical/private laboratory assays. One 

state noted that: “State/county epidemiology units need to use laboratory test 

results from clinical labs (non public health) for case reporting. This 

responsibility needs to be clarified at the national level. Whose responsibility 

is it to do the validation? Lack of a policy or pre-existing plans for validating 

clinical laboratory assays was in place.” 

Another state noted that: “According to the Clinical Laboratory 

Improvement Amendments (CLIA), it is not currently mandatory that patient 

addresses be included with all laboratory test requests. Labs may never 

receive this important information and often need to follow up on each case 

to obtain address information. Public health and reference labs must know 

the exact location of each case for community mitigation purposes—

aggregate state-level case counts are not helpful in this regard.” 

Rapid Testing 

Information is also needed to inform health care providers about the role of 

rapid testing. It was observed that: “The lack of a reliable rapid H1N1 

influenza test similar to one used for seasonal flu case management without 

comparable laboratory data leads to less than optimal decisions for the 
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patient. It also exposes others and leads to confusion among health care 

providers, and complicates influenza burden estimates. Many providers 

continued to over-rely on inaccurate quick tests because of their availability 

and belief it was “good enough”. Surveillance data may have been skewed 

by rapid test utilization and false negative tests could have delayed some 

appropriate patient care, which may have resulted in serious outcomes and 

even death. Transmission of disease could have been prolonged.” 

Surveillance in Schools and Universities 

Some states specifically commented on the challenges of conducting 

surveillance activities in educational settings, such as schools and 

universities. One state deployed an electronic school-based surveillance and 

reporting system to track school absenteeism. It was noted that “a number of 

local health departments did not utilize the system as it was perceived as 

being a significant burden on school nurses, who were short-staffed.” Thus 

“a lag in reporting occurred when all schools were not utilizing the system, 

and there was a perception that too many reporting systems existed.” 

Mitigation 

Strategies 

Employed: 

“A few states building on the CDC/APHL PHLIP pilot project were able to 

report electronically.” 

Recommendations 

Suggested: 

Surveillance System Administration/Monitoring 

 “Conduct an evaluation of epidemiologic and surveillance systems used 

during the H1N1 response to determine what worked well and what 

could be improved. As part of this process, determine what data 

elements were necessary and useful and cull those which were not for 

the purpose of streamlining and simplifying data acquisition and 

analysis.” 

Surveillance/Data Goals 

 “Surveillance priorities need to be clarified. Top priorities for 

surveillance are: (1) determining the severity of illness; and, (2) the risk 

factors for infection because these data drive decision-making. There 

should be movement toward greater nationwide consistency in the 

reporting of data. Use of sentinel providers is an option for more timely, 

less labor intensive surveillance.” 

Data Uniformity/Comparability 

 “Re-examine ILINet for the purpose of creating greater standardization 

and consistency among states as it pertains to definition interpretation 

(e.g. “widespread, “regional”, etc) and reporting.” 

Data Streams and Data Systems 

 “Obtaining more locally oriented and granular disease surveillance data 

(as compared to statewide or national) to better target public health 

response and services, given local variability of influenza outbreaks.” 

 “Revise surveillance systems to capture more specific data on at-risk and 
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vulnerable populations.” 

 “Expand the PHLIP standards for ELR to all reporting entities.” 

Confirmatory Testing 

 “CLIA should be modified to mandate that patient addresses be included 

with all lab test requests.” 

Rapid Testing 

 “Develop a reliable rapid test for H1N1 as well as seasonal flu.” 

Surveillance in Schools and Universities 

 “Continue to develop ongoing relationships at the state and federal level 

between public health and educational institutions. CDC, HHS and U.S. 

Department of Education should be communicating on how to better 

partner for routine and emergency disease surveillance.” 

 “Federal agencies should also better support their state/local 

counterparts in these efforts; U.S. Department of Education should 

loosen grant restrictions that interfere with collaboration with public 

health and that hinder reporting requirements.” 

 “Use existing surveillance system, rather than a new one, especially 

during an event.” 

 “Develop policies for access, data entry, integration of existing 

systems.” 

 “Continue to use school-based surveillance/reporting systems for all 

communicable disease surveillance; strengthen partnership between 

local health departments and schools to improve system.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Reporting Estimated Cases, Deaths and Hospitalizations 

Issue: B.2 Inconsistent case reporting methods led to differing case counts, 

conflicting messaging, and concerns about privacy. 

Issue Type: Policy and Legal 

Level: Federal and states. 

Discussion: States identified a number of barriers related to reporting of cases, 

hospitalization and deaths. 

Consistency Among Case Counts 

States noted that the “two options for hospitalization and death reporting, 
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Association of State and Territorial Health Officials Page 58 

while intending to allow flexibility to states, ended up creating confusion 

about how to compare/contrast data.” “Unlike most disease reporting 

systems where there are standardized case definitions and methods for 

national data comparison, H1N1 surveillance was either by lab confirmed 

hospitalizations and deaths for a majority of state and/or by syndromic data 

as well in 14 states.” Some states were not able to compare the datasets; 

therefore, reports were based solely on the lab confirmed data submitted. It 

was observed that “those states using in-patient hospitalizations data 

acquired via syndromic surveillance lacked adequate historical data, making 

discussions with reporters or data-driven pandemic response challenging at 

best and inconsistent/misguided at worst.” 

Regarding the use of confirmed case counts, a respondent remarked that 

“CDC did not follow a consistent procedure for surveillance of H1N1 at the 

national level,” which was “for confirmed case counts to be reported to CDC 

by states, after vetting of information by states.” It was observed, however 

that “CDC regularly reported (to the media and on its web site) data that 

included cases which it learned about through mechanisms that bypassed 

this consensus reporting procedure, resulting in reporting of inconsistent 

numbers of cases by CDC and states.” Others noted that states had to deal 

with significant media demands early in the outbreak to explain varying 

sources of data and differences in case counts. 

Another state commented that: “Data from CDC did not allow for a 

coordinated mechanism for timely comparisons between large cities. 

Aggregate cumulative case counts were not an accurate measure of 

incidence because states stopped testing at different times and/or used 

different testing criteria. Aggregate data was confusing and changed 

perception of the pandemic’s severity.” 

There needed to be additional outreach to hospitals and death certifiers 

regarding completeness and accuracy of H1N1-related death certificate 

filing. According to one respondent, “national death certificate data varied 

widely on H1N1, influenza, and pneumonia.” 

Ultimately, some states believed that “case-based reporting is not practical 

or sustainable over the course of an outbreak, especially if it were more 

severe than H1N1 turned out to be.” 

Messaging about H1N1 Case and Death Reports 

States agreed that the use of data in media communications was a 

complicated issue. There was a need for “enhanced explanations of CDC 

case, hospitalization, and death estimates to the public.” One respondent 

characterized it as: “in some instances, the federal government got ahead of 

states/locals when reporting state/local cases before families and 

communities had been notified.” States recognized the need and importance 

of collecting and packaging data in useful ways to numerous audiences with 

differing needs, particularly the media. 
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Balancing Case Reporting and Privacy 

Questions and concerns arose about balancing the need to disclose H1N1 

case information to state and local officials and the media to inform the 

public about H1N1 risks with federal and state privacy requirements. This 

issue arose in situations such as the disclosure of information through 

channels outside of public health (e.g., coroner’s office); disclosure of names 

of schools or school districts with students with confirmed H1N1 to inform 

other parents of risks; and the release of published updates about cases (e.g., 

MMWR). Privacy issues were raised with regard to the federal Health 

Insurance Portability and Accountability Act (HIPAA) and the Family 

Educational Rights and Privacy Act (FERPA), as well as state privacy laws. 

Mitigation 

Strategies 

Employed: 

Case Reporting 

 “Worked with reporting sources through the pandemic and eased some 

reporting requirements as local epidemiology warranted. It was difficult 

to balance partnership and reporting requirements.” 

Recommendations 

Suggested: 

Case Reporting 

Data types and systems: 

 “Use both lab-confirmed data and syndromic data (with clear 

definitions) in the future and provide appropriate funds so that work can 

be done and continue to find innovative ways to use syndromic and 

other nontraditional data sources.” 

 “CDC should regularly use state-based case reporting systems to assure 

consistent counts between the states and the federal government.” 

 “A national policy should be established using National Electronic 

Disease Surveillance System (NEDSS) to report incidence information 

and national notifiable diseases.” 

 “Patient, lab, and hospital databases across the nation should report the 

same data in a compatible way, preferably by using Health Level Seven 

electronic data exchange.” 

Case reporting procedures/standards: 

 “Develop a collection and reporting standard operating procedure (SOP) 

for disease surveillance that is sustainable during a long-term response. 

The guidance must include exceptions for targeted populations of 

interest, such as pediatric deaths, pregnant women, and health care 

workers.” 

 “CDC should: (1) provide case counts for each state using the same case 

definition and testing criteria; and (2) develop a sampling plan for larger 

cities and/or sentinel sites to do additional surveillance and reporting.” 

 “It is recommended that a standardized way of reporting cases that can 
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be easily understandable and track-able throughout the event be 

developed and implemented, as well as earlier availability of mortality 

rates.” 

 “Need a policy to determine and communicate when a novel disease is 

no longer novel.” 

 “More research is needed to produce national standards (case definition 

and which other elements should be reported) for syndromic 

surveillance.” 

 “CDC should clearly define the case message for the electronic health 

record.” 

Death reporting: 

 “Provide national educational tools and outreach to death certifiers on 

the importance of accurate and complete death reporting. Develop 

quality improvement projects involving certifiers so they know what 

additional questions/information would have been useful on a subset of 

the death certificates they certified.” 

 “Acknowledge that mortality data is a critical component of pandemic 

preparedness and tracking.” 

 “It was recommended the state develop an electronic death certificate 

system.” 

Identifying federal, state and local roles: 

 “Provide clear state health agency guidance for local health departments 

on trigger points for response to surveillance data and supplementary 

information on surveillance systems in a quick, easy to use format.” 

 “Federal and state governments should develop policies that clarify roles 

of the multiple response agencies and their responsibilities for data 

collection and support functions.” 

 “Federal and state governments should develop policy standards for data 

collection: what is to be collected, who collects it and who can use it. 

This data includes human health, school absenteeism and hospital 

capacity information.” 

 “States should develop standards for local policy development regarding 

data collection.” 

Case/Death Reports Messaging 

 “States should have the ability to preview CDC’s media messages so 

states could be ready for media questions, when feasible.” 

 “Common characteristics of success stories on this topic included 
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systematically identifying the most useful public information for the 

media, consistently placing it in context, and publicly releasing that 

information on a regular schedule and in a standard format.” 

 “Ensure that state and local public health officials are notified of case 

fatalities before reports are made at the national level.” 

 “When reporting data at the federal level, provide a disclaimer stating 

state and local data may be more accurate.” 

Disclosure and Privacy Issues 

 “Guidance is needed about the level of identifiable information and 

parties permitted to receive disclosures.” 

 “Well-established communication security for patient confidentiality 

(conference call/video system) is needed.” 

 “Further national discussion is needed concerning uniform criteria and 

standards in disclosure and privacy of case information provided by 

health departments to the public.” 

 “The federal government should clarify regulations regarding patient 

privacy and provide education for PIOs and media staff.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Laboratory Services Capacity 

Issue: B.3 The H1N1 response strained the laboratory capacities at the federal 

and state level. States’ and laboratory capacities need sustained 

funding. 

Issue Type: Policy 

Level: Federal and State 

Discussion: H1N1 Stressed Capacities 

Laboratory testing capacity was a concern at the state and federal level. For 

some states, laboratories were unable to keep up to date with processing 

specimens. It was observed that “this had a negative impact on surveillance, 

slowed down states’ abilities to correctly identify and describe the extent of 

the disease in a timely manner, and rendered states unable to provide needed 

support to local health departments.” 

One respondent noted that: “CDC’s backlog in the testing laboratory in the 

beginning of the epidemic caused delays in diagnosis and undue public 

concern. Some state public health laboratories were ready to perform the 

appropriate testing within hours of receiving the kits from CDC, but had to 
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wait over a week to receive authorization from CDC to use the kits.” Other 

states also noted that backups and delays at CDC’s laboratory hindered 

response activities. One jurisdiction without adequate public or private 

laboratory capacity “had to await testing results from CDC.” 

Another state noted: “the lack of electronic test reporting capabilities 

contributed to delays in reporting and analyzing epidemiological data. The 

process of reporting data manually is exhaustive and time consuming. This 

issue led to delays in reporting real-time results and characterization of the 

H1N1 pandemic.” 

Sustained Investment in Capacities 

State procurement and contracting processes conflicted with timeframes 

established by federal cooperative agreements, thereby delaying the 

purchasing of laboratory equipment and supplies, and hiring of laboratory 

and epidemiology personnel. 

Mitigation 

Strategies 

Employed: 

 “Used epidemiology staff as a gatekeeper to prioritize testing samples to 

address the demands on public health laboratories.” 

 “Where possible, purchased equipment through state contract vendor. 

Other equipment purchases are being attempted through departmental 

processes.” 

Recommendations 

Suggested: 

Addressing Stressed Capacities 

 “Explore the use of pre-staging laboratory activities in more than one 

laboratory in the country.” 

 “Consider making CDC laboratory test kits available to at least a subset 

of trusted private partners to increase laboratory surge capacity and 

overall sentinel surveillance capacity.” 

 “Develop better clinical guidelines and clinician education on which 

patients to test to reduce the testing burden on laboratories and target 

testing to public health needs.” 

 “Communication and cooperation with private laboratories is critical to 

a comprehensive understanding of the outbreak and a successful 

response.” 

Sustaining Capacity 

 “Secure sufficient and sustained funding to improve laboratory capacity 

to ensure more timely results and the ability to maintain a high level of 

testing, if necessary; this is especially critical in the territories.” 

 “The federal government should fund and expand electronic reporting 

capabilities nationally.”
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 “Funding restrictions were a barrier to H1N1 response at state public 

health labs. Provide more flexible funding guidelines to maximize and 

plan for workforce capacity issues as needed.” 

 More research is needed to produce national standards (case definition 

and which other elements should be reported) for syndromic 

surveillance. Funding is needed for states to implement those standards 

with laboratory capability. 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

[This space intentionally left blank] 

 
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III.C Medical Care and Countermeasures 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified 

The primary barriers identified related to medical care and countermeasures were (numbering does not

reflect a priority order for the barriers): 

C.1 Allocation, Priorities and Guidance–Federal and state approval processes for guidance 

on medical countermeasures and gaps in information in guidance limited their 

distribution and utility during the response. 

C.2 Stockpiles, Inventory Management and Supply Chain–Federal stockpiling decisions 

affected supply chains of key medical countermeasures, raising doubts about the ability 

of just-in-time supply mechanisms to respond to a widespread public health emergency. 

C.3 Stockpiles, Inventory Management and Supply Chain–States had difficulty assessing 

the status and location of supplies of medical countermeasures because of limits on their 

ability to access information about private supply chains. 

C.4 Stockpiles, Inventory Management and Supply Chain–Uncertainty over the 

ownership status of surplus medical countermeasures distributed from the SNS left states 

unable to deploy and use these materials quickly. 

C.5 Stockpiles, Inventory Management and Supply Chain–The lack of closer federal/state 

consultations about the types of SNS assets distributed to states hindered the 

effectiveness of those assets during the response. 

C.6 Administration and Dispensing Sites/Practices–States were uncertain about dispensing 

countermeasures to federal employee populations, fees for dispensing countermeasures, 

and the use of federal stockpile antivirals for prophylaxis. 

C.7 Tracking, Coverage and Adverse Events Reporting–Data elements and systems 

necessary to assess the use and potential adverse effects of federal countermeasures 

stockpiles must be better defined, especially for determining if countermeasures are being 

equitably distributed to the vulnerable populations. 

C.8 Recovery, Destruction and Disposal–States are concerned over the impending 

confusion and cost of recovering and disposing of expired and surplus countermeasures. 

C.9 PPE Mask Guidance–Delays and conflicts in federal guidance on respiratory protection 

led to confusion, caused shortages in supplies, and delayed the release of state and local 

stockpiles. 

C.10 Emergency Use Authorizations–Health care providers’ resistance to emergency use 

authorization (EUA) products may be limiting providers’ willingness to offer them to 
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patients. Information supplied to patients with EUA products may not ensure that 

informed consent is obtained. 

C.11 Medical Equipment Supplies and Tracking–Alterations in the scope and frequency of 

HHS requirements for National Hospital Available Beds for Emergencies and Disasters 

(HAvBED) System reporting caused frustration and confusion among states, hospitals 

and vendors. 

Selected Successes/Mitigations Identified 

Medical Care and Countermeasures Generally 

 “The manufacture and delivery of the vaccine were well executed.” 

 “New relationships/partnerships were established with pharmacies statewide.” 

Medical Care and Countermeasures Guidance 

 “Once approved, federal and state clinical and countermeasures guidance was distributed widely via 

the state portals to health care providers and the state health agency website.”

 “As federal and state clinical and countermeasures guidance evolved, the state health agency began 

highlighting just the changes in lengthy documents, so that providers could quickly assimilate the 

new information.” 

 “As guidance evolved, the state health agency began highlighting just the changes in lengthy 

documents, so that providers could quickly assimilate the new information.” 

 “Convened a work group of public, private and academic experts to review and inform the health 

agency’s development of recommendations regarding infection control, treatment, and testing.” 

 “Formed an influenza policy coordinating committee to draft guidance for addressing shortages of 

countermeasures in medical settings (including the use of N-95 masks).” 

Supply Chain, Stockpiles and Distribution 

 “The SNS/state stockpile was used efficiently and local SNS receipt and distribution were well 

executed.” 

 “The state developed and implemented a strategy for distributing the available SNS assets to the local 

jurisdictions.”

 “The direct delivery of vaccine to providers and pharmacies allowed efficiencies in transportation and 

workload during the event.” 

 “One state worked with its hospital association and regional government and response organizations 

to make a bulk purchase of surgical masks that were then delivered to facilities experiencing supply 

shortages. The state health agency continued to monitor the situation until the pandemic became less 

severe and demand for these supplies lightened. However, had the pandemic continued and/or 

become more severe, managing the supply chain issues would have been a major problem.” 

 “Personnel were dedicated to contacting every pharmacy in the state weekly to ascertain their 

antiviral stock levels and projected supply replenishment dates.” 

 “As expiration dates came very close, some antivirals were distributed so they could be used before 

expiration.” 
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Administering Countermeasures 

 “Establishing practice standards and protocols to allow paramedics assisting local health departments 

administer vaccine were helpful.” 

 “Private and chain pharmacies, and some FQHCs were provided with a cache of antivirals for underand uninsured individuals; individuals were taken at their word if they stated they had no insurance.” 

 New effective relationships and partnerships were established with pharmacies statewide. Private and 

chain pharmacies, and some FQHCs were provided with a cache of antivirals for under- and 

uninsured individuals. Individuals were taken at their word if they stated they had no insurance.”

N95s/PPE 

 “The state health agency published recommendations to use N95 masks for healthcare workers when 

performing aerosol-generating procedures.” 

 “The state health agency worked with the state occupational health agency to declare an N95 

shortage, thereby allowing the flexibility to prioritize the use of N95 masks.” 

 “State had hospitals’ preferred N95 brands stockpiled in state cache due to prior surveying of 

hospitals.” 

 “State health agency staff worked closely with over 750 nursing homes throughout the state to 

develop respiratory protection plans for staff.” 

N95 Guidance Issues 

 “In the absence of a clear federal policy, our state health department issued our own policy, which 

more closely followed the WHO policy and took into account the known science, the reality of 

limited PPE supply, and CDC’s insistence that in most cases it was not necessary to distinguish 

between seasonal influenza and H1N1.” 

 “The state health agency developed a series of recommendations that allowed for a greater level of 

discretion in the use of N95 masks. The state recommendations were based upon emerging evidence 

about the efficacy of surgical masks and the recognition that it had proved impracticable to follow the 

CDC guidance.”

 “The state reviewed and assessed, but did not use federal guidance. Instead it based its guidance on 

local epidemiology/circumstances.” 

 “Risk assessments, policies and a massive fit-testing effort were rolled out to support the October 

14th CDC recommendations. In the absence of clarity in the recommendations, and after heated 

discussion, the state health agency decided to require that anyone within 6 feet of a symptomatic 

patient would be required to wear a particulate respirator whether or not the symptomatic individual 

was masked.” 

 “All the state health agency could do was point providers and employers to the most recently 

published federal guidance and reports. It did not attempt to provide a state recommendation due to 

the uncertainty surrounding the guidance and because of reports from other states that health facilities 

were being cited by OSHA for following a state-level recommendation and not CDC’s.” 

 “Working with the state associations and the state’s health care regulatory agency, the health 

department developed new relationships that helped during the H1N1 response and will help in the 

future to work through these issues together. The delay in OSHA’s response to H1N1 N95 issues was 

seen as both a problem and a blessing: although uncertainty abounded, the bulk of the disease was 

gone before it was time to enforce the stricter rules that most did not want to adhere to.” 
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N95 Supply Issues/Shortages 

 “When the Strategic National Stockpile released millions of N95 respirators to be used in case of 

shortage, the public health agency had to create a process to work with the healthcare system to 

disseminate them in a fair and equitable manner. They also needed to work with the state 

labor/occupational health agency and several associations representing healthcare workers to ensure 

they were used per the federal guidance.” 

 “The health agency worked closely with the state’s occupational safety and health agency to 

determine how hospitals could document if PPE was in short supply and even provided some 

facilities with state PPE stock, in order for them to meet federal guidance.” 

 “State health department advised hospitals to use their best efforts to obtain N95s, and to carefully 

document supplies on hand, orders placed, etc. in order to defend against any future non-compliance 

action.” 

 “The state surveyed hospitals two years ago to determine the brand of respirator they purchased. This 

brand was purchased for the state’s emergency response cache. When the SNS assets were deployed 

to the state, a percentage was placed in the state’s cache, and a corresponding percentage of the state 

assets (the preferred brands identified earlier) were distributed to hospitals.” 

 “The state health agency developed a procedure/protocol for the healthcare facilities to utilize for 

requesting PPE. As part of the campaign rollout, an educational webinar was developed and offered 

which discussed the stockpile, hierarchy of controls and determinants for filling requests, education of 

SNS inventory management and ordering, and shipping information. These sessions were repeated 

five times to give hospitals/healthcare facilities ample opportunity to participate. Webinars were 

recorded and offered at later dates as well.” 

Medical Equipment Tracking 

 “The state health agency requested hospitals to respond to both the HHS situational awareness report 

and the HAvBED requests.”

 “The HAvBED working group, formed by ASTHO, sent a letter and consensus documents, which 

were created in response to the new HAvBED data elements and consensus of operations (CONOPS) 

document, to HHS. The work group made recommendations on the HAvBED data elements and the 

CONOPS document, which contained both general comments as well as suggested revisions.” 

 One state agency “provided health care facilities with templates designed to make reporting easier.” 

 “Health agency executive management worked directly with LEMSAs and state hospital associations’ 

leadership to identify issues, delineate the appropriate reporting relationships, and reduce confusion 

and friction associated with the federal reporting requests.” 

Emergency Use Authorizations 

 “The agency provided documentation of the Emergency Use Authorization and the FDA-approved 

fact sheets with each order the health agency shipped.” 

 “Placed the EUAs, fact sheets and guidance on the state’s web site and communicated this 

information on the health agency’s weekly webcasts to partners.” 

Alternate Care Sites 

 “The functional use of temporary triage shelters in hospitals was also identified as a benefit.” 
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Waivers/EMTALA 

 “The waiver process for temporary expansion of hospital bed space was effectively distributed by 

state health services regulatory agency.” 

Barriers/Recommendations Identified Detail 

[Please note that the sections below apply to all medical countermeasures (antivirals, personal 

protective equipment (PPE), medical supplies) with the exception of vaccine, which is 

addressed in Section III.D. Issues related specifically to PPE N95 guidances and supplies are 

addressed separately as identified below.] 

Allocation, Priorities and Guidance 

Issue: C.1 Federal and state approval processes for guidance on medical 

countermeasures and gaps in information in guidance limited their 

distribution and utility during the response. 

Issue Type: Federal; State 

Level: Policy 

Discussion: Medical Countermeasures Guidance 

States noted that “federal and state approval processes for guidance on 

medical countermeasures slowed their distribution of these guidances to 

clinicians.” One respondent observed that “clinical guidance from CDC was 

delayed at the federal level, with little information on the content and 

timeframe for release.” Another person noted that “the release of guidance 

was also slowed at the state level by the excessive length of time it took for 

review and approval, especially when executive-level approval was required 

from more than one agency.” It was felt that “state processes slowed the 

release of important information to clinicians in a timely manner, causing 

clinicians to rely on CDC guidance rather than on more state-specific 

guidance.” 

 Guidance for using antivirals from the SNS: Federal guidance was not 

provided as to the appropriate use of the antivirals received as part of the 

SNS. One respondent noted that “guidance from CDC for treatment was 

excellent; however, guidance on how and when to use the stockpile was 

absent.” One state noted that “persons who were under- and uninsured 

may not have received treatment in a timely manner due to the lack of 

federal guidance regarding permitted recipients for stockpiled 

antivirals.” Another noted that “conflicting guidance for the use of 

antiviral prophylaxis left staff and the public confused.” 

 Intravenous antivirals/severe case guidances: A respondent believed 

that: “The federal government provided slow and insufficient guidance 

on the use of intravenous (IV) antivirals and the management of severe 
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Association of State and Territorial Health Officials Page 69 

H1N1 cases. The issuance of the EUA for Peramivir was needed much 

sooner than it was provided. Additionally, alternate IV antivirals were 

needed if viral resistance developed. The state health agency was unable 

to provide recommendations to physicians on effective treatment and 

management of severe/life-threatening cases of H1N1, where oral and 

inhalational antivirals were not effective options (e.g., severely ill 

patient on ventilator).” 

 Determining alternative standards of care for MCMs: The issue of 

alternative (or “alternate” or “crisis”) standards of care was also raised. 

As one agency observed: “With vaccine being sent primarily to local 

health departments because of initial short supplies and federal 

directives to hold local vaccination clinics, because physicians in 

medical care settings were not getting H1N1 vaccines, these 

practitioners were not being optimally used and were not equipped with 

supplies available in the community.” Concerns were raised that policy 

decisions seemingly directing vaccine away from providers in essence 

created an alternative standard of care for health care providers. 

Mitigation 

Strategies 

Employed: 

MCM Guidance 

 “As guidance evolved, the state health agency began highlighting just 

the changes in lengthy documents, so that providers could quickly 

assimilate the new information.” 

Intravenous Antivirals/Severe Case Guidances 

 “Convened a work group of public, private and academic experts to 

review and inform the health agency’s development of recommendations 

regarding infection control, treatment, and testing. However, this group 

could not address provider questions on clinical management of 

individual cases of severe/life-threatening disease. Instead the health 

agency queried the few infectious disease physicians employed by the 

agency, as well as the Emerging Infections Network (EIN) of the 

Infectious Diseases Society of America. Members of the EIN were able 

to offer some guidance to clinicians about awareness and management 

of severe H1N1 cases, but they were unable to offer guidance on 

alternative antivirals to treat those cases.” 

Determining Alternative Standards of Care for MCMs 

 “Formed an influenza policy coordinating committee to draft guidance 

for addressing shortages of countermeasures in medical settings 

(including the use of N-95 masks).” 

Recommendations 

Suggested: 

Medical Countermeasures Guidance 

 “Federal clinical guidance should be developed and disseminated more 

rapidly.” 

 “State guidance approval processes should be streamlined to expedite 

information release to clinicians during public health emergencies.” 
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Association of State and Territorial Health Officials Page 70 

Guidance for Antivirals 

 “CDC should develop, standardize, and communicate consistent 

reporting policies for antiviral doses administered to states to ensure that 

those policies are in place before a public health emergency.” 

 “Deploy antivirals as appropriate to pharmacies and health centers much 

earlier in an event; develop protocols and policies for community 

members to access the medication.”

 “Maintain and strengthen relationships with private and chain 

pharmacies.”

Intravenous Antivirals/Severe Case Guidances 

 “The nation could benefit from something akin to the Advisory 

Committee on Immunization Practices (ACIP), but for medical 

countermeasures. Such a group (an advisory committee on medical 

countermeasures or “ACMC”) would follow the ACIP model in 

structure and methods. The group would meet on a regular basis to 

review the latest evidence and make or update recommendations on 

medical countermeasures for biological, chemical and radiological 

events (natural or man-made). Rather than providers having to search for 

medical countermeasure recommendations from multiple, possibly not 

current, and possibly conflicting sources, the ACMC would provide the 

definitive and most current guidance for the nation.” 

“Perhaps unlike ACIP, this group would also evaluate and recommend 

medical countermeasures not yet FDA approved, but in the latter stages 

of clinical trials, thereby offering emergency alternatives when there are 

no, or only inadequate, FDA-approved countermeasures. The group 

would develop standing EUAs for non-approved products (including 

those appropriate for use in pediatric and pregnant populations) that 

could be rapidly issued by the FDA in an emergency. The ACMC 

evaluations and recommendations would help drive consensus on policy 

and funding decisions related to research and development, and 

manufacturing of medical countermeasures.” 

Determining Alternative Standards of Care for MCMs 

 “Federal and state agencies should work more closely with practitioners 

and the health care industry to reach agreement about countermeasures, 

who they apply to and when, as well as decisions around allocation 

decisions when MCMs are in short supply.” 

[Sources: Survey: X Meetings: X Environmental Scan: ] 
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Association of State and Territorial Health Officials Page 71 

Stockpiles, Inventory Management and Supply Chain 

Issues: C.2 Federal stockpiling decisions affected supply chains of key medical 

countermeasures, raising doubts about the ability of just-in-time 

supply mechanisms to respond to a widespread public health 

emergency. 

C.3 States had difficulty assessing the status and location of supplies of 

medical countermeasures because of limits on their ability to access 

information about private supply chains. 

C.4 Uncertainty over the ownership status of surplus medical 

countermeasures distributed from the SNS left states unable to 

deploy and use these materials quickly. 

C.5 The lack of closer federal/state consultations about the types of SNS 

assets distributed to states hindered the effectiveness of those assets 

during the response.

Issue Type: Policy 

Level: State; Federal 

Discussion: Strategic National Stockpile (SNS) Ordering 

States indicated that “the required data elements and process for resupplying 

antiviral medications from the SNS were not clearly outlined.” State health 

agency staff “spent valuable time answering data questions multiple times 

when information was submitted after the first request.” When one state 

experienced a commercial shortage of antiviral medications (as validated by 

wholesale distributors, retail pharmacies and local communities), the state 

felt “it was difficult to convince federal authorities the shortage existed.” 

Supply Chain Visibility and Capacity 

 Pharmacy supply chain visibility: States identified the need for better 

supply chain visibility of antiviral stocks and dispensing through 

pharmacies. During the initial outbreak of H1N1 influenza, there was a 

shortage of antivirals in the pediatric formulation. A state noted that: 

“Often patients would have to go to multiple pharmacies to find one that 

had the antivirals in stock. This was particularly concerning for high-risk 

children because the pediatric formulation was in shorter supply than the 

adult formulation.” 

 Supply chain capacity: States expressed concerns over “the ability of 

health care facilities to procure adequate amounts of medical supplies 

via commercial chains and the ability of commercial supply chains to 

produce ample supplies during a more significant pandemic event than 

H1N1 turned out to be.” There was a perception that the “federal 
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government purchased mass quantities of medical supplies for the SNS, 

which caused a supply shortage leading to a prolonged delay for health 

care facilities to obtain their standard supply of medical care items (i.e., 

sanitizer, surgical masks, N95 masks, bandages, syringes, etc.).” It was 

also reported that, because of supply shortages, “health care facilities 

experienced price gouging on items that were in limited quantity.” 

Inventory Management 

States believed that they “held antivirals in state stocks too long as they 

waited for the subsequent waves of the H1N1 pandemic to materialize.” This 

gave rise to the concern that some antivirals went/will go unused. 

States encountered barriers when they tried to share SNS assets between 

states. One state reported: “Policies pertaining to interstate transportation of 

pharmaceuticals are very unclear. If SNS pharmaceuticals arrive in one state, 

transporting them to another state is not allowed and presents a significant 

policy barrier. A neighboring state requested pharmaceuticals from our state; 

the distributor refused to ship them across the border.” 

Distribution of SNS Assets 

States frequently commented on barriers arising from the types, timing and 

use of SNS assets distributed to the states. One state characterized it as: “The 

distribution of SNS materiel without a state request resulted in the delivery 

of excess assets. Some SNS assets received at the state level were not 

matched with state needs and resulted in excess resources. The public health 

need would have been better served if they had queried the states prior to 

SNS distribution.” 

Another state, one that agreed to take SNS assets, voiced a different set of 

concerns: “When CDC asked states if they would like a shipment of SNS 

assets early in the pandemic, the state felt compelled to request these assets. 

However, the SNS assets became a burden when the PHER funds did not 

carryover and the state had to provide funding for management, 

transportation, and storage.” 

Ownership of Medical Countermeasures 

States expressed uncertainty about the ownership of federal medical 

countermeasures and assets sent to them such as antivirals, PPE, respirators, 

vaccine and ancillary supplies. Some states voiced ongoing questions about 

perceived “inconsistent answers about the ownership of those assets once 

they have been distributed to the states.” Specifically, states “needed to 

understand if they had to continue to treat the asset as a federal asset, a 

federal asset now in the possession of the state, a state or local asset once it 

was delivered, or something else.” 

As one respondent noted that “the lack of clear answer made it difficult to 

know what decisions a state or local government could make regarding the 

materials once the state/local had taken possession of them.” States 

expressed that their ultimate desire was to “repurpose distributed medical 

countermeasure to avoid expiration, wasting, and disposal issues.” 
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Association of State and Territorial Health Officials Page 73 

Mitigation 

Strategies 

Employed: 

Strategic National Stockpile (SNS) Ordering 

 “After a period of time, additional Tamiflu oral suspension was pushed 

to all states when the shortage in commercial supplies was finally noted 

at the federal level. This resulted in many local communities in the states 

experiencing shortages early during the outbreak, but they were not 

resupplied for up to four weeks from the stockpile.” 

Pharmacy Supply Chain Visibility 

 “Personnel were dedicated to contacting every pharmacy in the state 

weekly to ascertain their antiviral stock levels and projected supply 

replenishment dates.” 

Supply Chain Capacity 

 “One state worked with its hospital association and regional government 

and response organizations to make a bulk purchase of surgical masks 

that were then delivered to facilities experiencing supply shortages. The 

state health agency continued to monitor the situation until the pandemic 

became less severe and demand for these supplies lightened. However, 

had the pandemic continued and/or become more severe, managing the 

supply chain issues would have been a major problem.” 

Inventory Management 

 “As expiration dates came very close, some antivirals were distributed 

so they could be used before expiration.” 

Recommendations 

Suggested: 

Strategic National Stockpile (SNS) Ordering 

 “The federal government needs to: (1) clearly define the data it needs 

from states when requesting additional materials from the stockpile; (2) 

identify the timeline for receipt of order and response to the state; (3) 

maintain better communications with the state during the process to 

avoid duplication and to reduce the time between request and response; 

and, (4) make tools (such as a dashboard) available to SNS coordinators 

for managing stockpile assets.” 

Pharmacy Supply Chain Visibility 

 “Establish a federal-level system for monitoring stock levels of a 

specific set of pharmaceuticals such as antivirals and antibiotics in 

national corporate pharmacy chains. This information should be given to 

states at the regional level so that providers can be advised of stock 

levels on at least a regional basis.” 

Supply Chain Capacity 

 “SNS supplies should be purchased in advance of an emergency, rather 

than essentially limiting the national supply chain in the midst of an 

emergency. If medical supply providers continue just-in-time 

manufacturing, there will always be medical supply shortages during 

nationwide emergencies such as pandemics. If the federal government 
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Association of State and Territorial Health Officials Page 74 

drains available medical supplies when purchasing for the SNS, this 

defeats the SNS’s primary purpose. Further, it causes an extra loop in 

the supply chain process for health care facilities; during an emergency, 

they are unable to obtain supplies through clogged supply channels and 

then are forced to go through SNS.” 

Inventory Management 

 Regarding the interstate sharing of SNS assets, a state noted: “Although 

this barrier involves state laws, a federal policy that allows for SNS 

assets, including pharmaceuticals, to be transported across state borders 

would be very helpful in the coordination and implementation of 

response efforts. This policy should provide clear guidance on 

pharmaceuticals and medical devices, and could be part of the 

emergency declaration from the president.” 

Distribution of SNS Assets 

 “The CDC policy for distribution of SNS assets to states should be more 

metered, thereby allowing more time for additional epidemiological 

analysis to better characterize what types of SNS assets are necessary.” 

 “Distribute assets based on needs through formal state requests 

following the established Division of Strategic National Stockpile 

(DSNS) protocol.” 

 “More accurate information regarding SNS delivery and disposal is 

recommended. The policy should be that SNS materials are delivered 

during business hours unless an emergent need is identified.” 

 “Allow dispensing of SNS products from non-traditional service 

providers during an event.” 

 “Develop policies and guidance on SNS disposal.” 

 “Clarify Receipt Stage and Storage Site (RSS) protocols.” 

 “The federal government should develop and implement policies 

regarding the use of SNS resources once delivered. These policies may 

need to be revised or specialized for each incident.” 

 “The state should develop policies regarding shipment of SNS resources 

to local receiving sites that are appropriate to the level of urgency of 

need.” 

 “Allow the use of National Guard staff, paid for by federal funds, to 

increase surge capacity for law enforcement during large national events 

requiring the distribution of SNS assets.” 

Ownership of Medical Countermeasures 

 “A clear definition needs to be established by the federal government 
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Association of State and Territorial Health Officials Page 75 

regarding the designation of each federal asset that is delivered to the 

state. It should be specified if the materials are still considered to be 

federal assets and therefore must be treated in a certain way, or, if once 

it is released to the state or local entities, no federal involvement 

remains.” 

[Sources: Survey: X Meetings: X Environmental Scan: ] 

Administration and Dispensing Sites/Practices 

Issue: C.6 States were uncertain about dispensing countermeasures to federal 

employee populations, fees for dispensing countermeasures, and 

the use of federal stockpile antivirals for prophylaxis. 

Issue Type: Policy; Legal 

Level: Federal 

Discussion: Administering MCMs to Federal Employees 

Federal and state agencies need to better coordinate the identification of 

federal employee populations within each state and clarify how 

countermeasures will be provided to these populations. A state observed that 

“federal agencies need to reach out to states and locals to ensure they are 

accounted for in medical countermeasure plans.” 

Payment/Reimbursement Issues 

States raised questions about their ability to allow MCM dispensers to 

charge a small fee to cover the cost of MCM dispensing. It was noted that 

“state legal counsel need to clarify if it would violate the federal Stark Act 

anti-kickback law if a physician were to charge a dispensing fee if they had 

also prescribed the MCM.” 

Exploring the Use of Antivirals for Prophylaxis 

Some states expressed interest in “exploring the implications of expanding 

the use of stockpiled antivirals for post-exposure prophylaxis versus 

reserving them strictly for treatment purposes.” However, others noted that 

“it is feared that there will not be enough supply for those who really need 

antivirals.” One respondent concluded that “some believe that, although 

federal guidance says stockpiled antivirals are to be used for treatment only, 

at some point if the disease is severe enough, it will be appropriate to use 

them for post-exposure prophylaxis.” 

Mitigation 

Strategies 

Employed: 

None identified 
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Association of State and Territorial Health Officials Page 76 

Recommendations 

Suggested: 

Administering MCMs to Federal Employees 

 “State and local health agencies should work with federal agencies to 

clarify the number of federal workers, contractors, and family members 

to be covered by federal continuity of operations plans (COOP) versus 

those covered as part of the general population of the jurisdiction. They 

should also clarify who will be responsible for administering the assets 

as well as assuring that assets are used according to recommended 

clinical guidelines.” 

Payment/Reimbursement Issues 

 “Clarify whether states can allow dispensers of MCMs to charge a small 

fee covering costs of dispensing MCMs like vaccine or antivirals.” 

 “Clarify whether the Stark Act would be violated if a physician were to 

charge a dispensing fee while acting as both prescriber and dispenser.” 

Exploring the Use of Antivirals for Prophylaxis 

 “The federal government and the states should begin to explore issues 

surrounding the potential use of stockpiled antivirals for prophylaxis, 

including where such use should be limited to post-exposure scenarios 

or would also include prophylaxis of the general population.” 

[Sources: Survey: Meetings: Environmental Scan: X ] 

Tracking, Coverage and Adverse Events Reporting 

Issue: C.7 Data elements and systems necessary to assess the use and potential 

adverse effects of federal countermeasures stockpiles must be 

better defined, especially for determining if countermeasures are 

being equitably distributed to the vulnerable populations. 

 

Issue Type: Policy 

Level: State 

Discussion: Tracking the Use of SNS Assets 

States raised questions about the level of tracking required for SNS assets 

and the types of information that must be tracked. One respondent noted that 

“it is unclear whether SNS assets must be tracked to the patient level; states 

tracked assets to varying degrees.” 

Tracking Access to Antivirals by Special and Vulnerable Populations 

There should be a way to determine if stockpile assets were distributed in an 

equitable way. States expressed concern that “under- and uninsured 

individuals will lack access to antivirals if the primary mode of distribution 

is through private providers.” Because these populations do not have 
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Association of State and Territorial Health Officials Page 77 

insurance or cannot afford treatment, “this causes distinct equity issues for 

those who may need antivirals.”

One state related that it had: “No process for local health departments to use 

the stockpile for under- and uninsured individuals. As a result, the state 

waited too long to push out antivirals to pharmacies for these populations. 

At-risk populations who used CHC/FQHCs did not receive antivirals in a 

timely manner. CHC/FQHCs were frustrated with their inability to access 

medication for their patients quickly and easily.”

Tracking Efficacy and Harm of Antivirals 

State health officials acknowledged that “antiviral drugs have never been 

used on this scale before, so it will be important to track their efficacy and 

harm.” Data is also needed to determine if those taking antivirals received 

benefits from them. States believe that “there should be crucial clinical 

information about antivirals’ efficacy and/or harm that emerges from the 

H1N1 outbreak” which can be used to inform future decision making. 

Mitigation 

Strategies 

Employed: 

Tracking Access to Antivirals by Special and Vulnerable Populations 

 “New effective relationships and partnerships were established with 

pharmacies statewide. Private and chain pharmacies, and some FQHCs 

were provided with a cache of antivirals for under- and uninsured 

individuals. Individuals were taken at their word if they stated they had 

no insurance.”

Recommendations 

Suggested: 

Tracking the Use of SNS Assets 

 “CDC should clarify whether states are required to track SNS assets to 

the patient level.” 

 Options identified for tracking SNS included: “1) tracking vaccinated 

children through existing immunization registries; 2) tracking 

immunized adults in order to know who has received a first dose if two 

doses are recommended (some states track antivirals this way); and 3) 

tracking health care workers, including volunteer emergency workers, 

who receive immunization.”

Tracking Access to Antivirals by Special and Vulnerable Populations 

 “Deploy antivirals as appropriate to pharmacies and health centers much 

earlier in an event; develop protocols/policies for community members 

to access the medication.”

 “Maintain and strengthen relationships with private and chain 

pharmacies.”

[Sources: Survey: Meetings: X Environmental Scan: X ] 
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Association of State and Territorial Health Officials Page 78 

Recovery, Destruction and Disposal 

Issue: C.8 States are concerned over the impending confusion and cost of 

recovering and disposing of expired and surplus countermeasures. 

Issue Type: Policy; Legal 

Level: Federal; State 

Discussion: States’ discussions about the recovery, destruction, and disposal of MCMs 

have focused so far on vaccine issues. See “Recovery, Destruction and 

Disposal” discussion in Section III.D, “National Vaccination Campaign.”

Mitigation 

Strategies 

Employed: 

See “Recovery, Destruction and Disposal” discussion in Section III.D, 

“National Vaccination Campaign.”

Recommendations 

Suggested: 

See “Recovery, Destruction and Disposal” discussion in Section III.D, 

“National Vaccination Campaign.”

[Sources: Survey: X Meetings: Environmental Scan: X ] 

PPE Mask Guidance 

Issue: C.9 Delays and conflicts in federal guidance on respiratory protection 

led to confusion, caused shortages in supplies, and delayed the 

release of state and local stockpiles. 

Issue Type: Policy; Legal 

Level: Federal; State 

Discussion: Guidance 

States’ views were in consensus about balancing between the need for 

guidance based on sound evidence/revising the guidance as more 

information about the nature of the outbreak became available with practical 

implementation and response issues. 

 Guidance concerns/conflicts: There were conflicting opinions as to the 

level of personal protective equipment required (N95 or surgical mask) 

for healthcare workers in the H1N1 response. States cited a range of 

potential guidances from CDC, OSHA, NIOSH, IOM, state health and 

occupational agencies, and even some from local health agencies 
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Association of State and Territorial Health Officials Page 79 

One state observed that: “The CDC recommendation that hospital staff 

treating suspected or confirmed cases of H1N1 use N95 masks was 

based in large part upon the recommendations of a committee formed by 

the Institute of Medicine (IOM), which did not consider issues 

associated with cost and logistics during their deliberations. At the time, 

there was inconclusive information associated with the relative benefits 

of N95 and surgical masks. IOM’s conservative recommendation 

reflected this lack of information. CDC used this recommendation as the 

foundation of their direction to the states despite the availability of 

conflicting opinions about the relative efficacy of these two options.” 

Some states issued their own guidance addressing the N95 mask issue. 

Other states were not comfortable providing doing so. One state health 

agency noted that, while it “felt very comfortable providing general 

infection control guidance, it is not the agency regulating healthcare 

settings and therefore was not comfortable providing N95 guidance.” 

States believed that “the indecision and uncertainty with the N95 

guidance hindered planning and response activities.” Some states noted 

that there was “a lack of definitive clinical or other scientific data 

regarding mode of transmission and the effectiveness of facemasks vs. 

N95 respirators for healthcare and other at-risk workers.” A respondent 

observed that “health agencies were placed in the position of having to 

delay policy and procedure development, and postponing efforts 

involved in implementing statewide fit-testing programs as the 

clinical/scientific issues were resolved.” 

The range of guidances and conflicts/inconsistencies among them left 

health care and other affected organizations wondering which guidance 

to follow (OSHA, CDC, IOM, state health departments, etc.). One 

person stated that “even if an organization followed CDC/state health 

guidance, it was not clear to states or health care providers whether 

OSHA was adopting any of these guidances as an employee health 

requirement or what would be the result if a provider adhered to a state 

guidance that was different than CDC's.” 

 Logistical and practical considerations: Some states believe that 

“economic and logistical concerns (i.e., affordability and availability of 

N95 masks) did not seem to be taken into consideration when CDC 

created the mask guidance.” 

 Labor/employer issues: Some saw that “the CDC recommendation put 

many organizations in awkward positions with employees and their 

unions who insisted that they comply with the N95 recommendations.” 

Other states wondered “how to encourage health care responders to 

continue showing up for work if they are not provided proper 

protection.” These states viewed it as “the duty of employers to ensure 

their workers are protected with specified PPE.” 
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Association of State and Territorial Health Officials Page 80 

 Enforcement/legal uncertainties: Conflicts among CDC, OSHA and 

state health and occupational directives/guidances on PPE/N95 masks 

raised concerns among providers about potential enforcement and other 

liabilities. It was noted that “hospitals and other institutions were 

concerned that OSHA could potentially penalize them for following 

their states’ PPE recommendations if they conflict with OSHA’s or other 

federal guidance on worker safety (e.g., NIOSH).” There was also 

concern raised that “lack of compliance with NIOSH recommendations, 

even when not officially adopted by OSHA, may give grounds for 

private litigation if a worker or patient is injured, especially if the 

institution has received an OSHA violation notice.” It was suggested 

that “better alignment between CDC and OSHA would reduce both 

confusion and legal risk for state and local health systems.” 

 Messaging/credibility concerns: States encountered challenges with 

messaging effectively to/from key stakeholders, front line clinicians, 

hospitals regarding practice standards as mask guidances evolved and 

CDC/OSHA conflict issues arose. Some state respondents believe that 

“the length of time it took to resolve these issues and the confusion that 

was involved resulted in some credibility concerns regarding the 

guidance that was being proffered by CDC.” 

Another state noted that “states with state OSHA programs had the 

flexibility to make policies less restrictive than federal OSHA 

guidelines, but this caused confusion in states with media outlets that 

covered multiple states.” 

Supply Issues/ Shortages 

The requirement to use N95 respirators for H1N1 resulted in supply 

shortages and required extra time and resources by providers using SNSsupplied N95s. 

 Inability to implement guidance: States felt that “there was no way to 

operationalize or implement the CDC guidance standards given the 

supplies of N95 masks available.” Some expressed that “there was no 

need to have such restrictive standards given the nature of the H1N1 

disease; the N95 guidance caused unnecessary confusion and complexity 

for health care providers.”

 Types of respirators: A respondent commented that: “N95 respirators 

from the federal stockpile were boxed and shipped by size and 

manufacturer, but health agencies would receive a mixture of different 

sizes from different manufacturers (e.g., Brand A in small and large 

only; Brand B in med-large only; Brand C in medium only). This made 

it difficult to provide the sizes and brands that hospitals regularly used. 

If hospitals could not get the brands/sizes to which their employees had 

been fit-tested, hospitals would have to fit-test to the new brands/sizes.” 

In some states, “hospitals did not want to accept the federally-supplied 
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Association of State and Territorial Health Officials Page 81 

respirators from the SNS, as these were not approved for surgical 

settings.”

 Fit-testing issues: Early in the pandemic, there was confusion regarding 

the requirement for fit-testing of N95 masks obtained through the SNS. 

As one state noted, “healthcare facilities wanted to remain in compliance 

with NIOSH, but the protocol/guideline was not firmly established at the 

outset.” Another state noted that: “Had the health agency shipped 

hospitals a new type of respirator from the SNS that the hospital does 

not currently use, the hospital would have been forced to refit all of their 

employees. Because fit-testing takes about 30 minutes for each 

employee; this could have caused a serious delay in services for some 

healthcare systems with thousands of employees. Thus, this was not a 

realistic expectation to put on healthcare facilities.”

 Distribution/supply chain issues: States experienced significant 

challenges with the N95 mask supply chain throughout the pandemic 

response. State and local health agencies did not know what brands of 

PPE were in the stockpile. 

Some states believed that: “CDC’s guidelines and the possibility of 

government purchasing a majority of manufactured N95 respirators 

caused a shortage of N95 respirators in hospitals. N95 manufacturers 

were unable to keep pace with the demand creating a huge backlog of 

orders and the exhaustion of local supplies. As local public health and 

health care facilities endeavored to comply with the CDC, they 

purchased a variety of makes and types requiring a new round of fittesting for facilities receiving masks other than their usual brands.” 

One state observed that: “Mid-way through distribution planning for 

N95 masks, CDC guidance with the hierarchy of controls was released, 

which made it difficult to change distribution plans to take the controls 

into account. It was also difficult to interpret and communicate the 

requirements that healthcare providers/hospitals had to meet in order to 

receive SNS N95 materials. States had very little time to develop an 

educational campaign for healthcare facilities around the Hierarchy of 

Controls used for determining which facilities would receive N95s. This 

guidance was released at the peak of the season, and thus was not as 

effective in communicating the intent and purpose for using this 

method.”

 Competing demands for respirators: A number of states also voiced the 

need to consider other sectors and instances in which N95 respirators 

should be used. Because respirators are essential components of 

infection prevention and control strategies for airborne pathogens such 

as tuberculosis, a shortage of respirators “could put healthcare workers 

at increased risk in the event proper respiratory protection is unavailable 

for the care of patients infected with airborne-transmissible pathogens.” 

One respondent remarked that “as more N95 masks were used for 
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Association of State and Territorial Health Officials Page 82 

H1N1, it became increasingly difficult for public health and health care 

organizations to find sufficient supplies for treating patients with TB and 

other communicable diseases for which N95 use is essential.” 

Another state observed that “there was a dedicated focus on health care 

workers in the deliberation over N95 uses and supplies, but the focus 

also needed to be expanded to other professions likely at risk from 

H1N1.” One state agency noted that “there are political ramifications 

and relationships with other entities that use N95s that must be taken 

into account; police and fire departments as well as organizations such 

as OSHA and SHEA should be consulted about N95 supply needs.” One 

health agency representative concluded that “N95s are needed to be 

prepared for all hazards, not just H1N1; the entire N95 cache should 

never be depleted.” 

Mitigation 

Strategies 

Employed: 

Guidance Issues 

A number of states reported developing their own N95 guidance, while 

others used CDC guidance with other mitigation strategies: 

 “In the absence of a clear federal policy, our state health department 

issued our own policy, which more closely followed the WHO policy 

and took into account the known science, the reality of limited PPE 

supply, and CDC’s insistence that in most cases it was not necessary to 

distinguish between seasonal influenza and H1N1.” 

 “The state health agency developed a series of recommendations that 

allowed for a greater level of discretion in the use of N95 masks. The 

state recommendations were based upon emerging evidence about the 

efficacy of surgical masks and the recognition that it had proved 

impracticable to follow the CDC guidance.”

 “The state reviewed and assessed, but did not use federal guidance. 

Instead it based its guidance on local epidemiology/circumstances.” 

 “Risk assessments, policies and a massive fit-testing effort were rolled 

out to support the October 14th CDC recommendations. In the absence 

of clarity in the recommendations, and after heated discussion, the state 

health agency decided to require that anyone within 6 feet of a 

symptomatic patient would be required to wear a particulate respirator 

whether or not the symptomatic individual was masked.” 

 “All the state health agency could do was point providers and employers 

to the most recently published federal guidance and reports. It did not 

attempt to provide a state recommendation due to the uncertainty 

surrounding the guidance and because of reports from other states that 

health facilities were being cited by OSHA for following a state-level 

recommendation and not CDC’s. The agency was not in complete 

agreement with CDC’s recommendations, so it did not endeavor to 
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Association of State and Territorial Health Officials Page 83 

publicly support the guidance by recommending the use of N95s. 

However, the health agency did not offer an official recommendation or 

guidance on the N95 issue. The agency simply assured that partners and 

stakeholder were made aware of new information as it was released.” 

 “Working with the state associations and the state’s health care 

regulatory agency, the health department developed new relationships 

that helped during the H1N1 response and will help in the future to work 

through these issues together. The delay in OSHA’s response to H1N1 

N95 issues was seen as both a problem and a blessing: although 

uncertainty abounded, the bulk of the disease was gone before it was 

time to enforce the stricter rules that most did not want to adhere to.” 

Supply Issues/Shortages 

 “When the Strategic National Stockpile released millions of N95 

respirators to be used in case of shortage, the public health agency had to 

create a process to work with the healthcare system to disseminate them 

in a fair and equitable manner. They also needed to work with the state 

labor/occupational health agency and several associations representing 

healthcare workers to ensure they were used per the federal guidance.” 

 “The health agency worked closely with the state’s occupational safety 

and health agency to determine how hospitals could document if PPE 

was in short supply and even provided some facilities with state PPE 

stock, in order for them to meet federal guidance.” 

 “State health department advised hospitals to use their best efforts to 

obtain N95s, and to carefully document supplies on hand, orders placed, 

etc. in order to defend against any future non-compliance action.” 

 “The state surveyed hospitals two years ago to determine the brand of 

respirator they purchased. This brand was purchased for the state’s 

emergency response cache. When the SNS assets were deployed to the 

state, 30% were placed in the state’s cache, and 30% of the state assets 

(the preferred brands identified earlier) were distributed to hospitals.” 

 “The state health agency developed a procedure/protocol for the 

healthcare facilities to utilize for requesting PPE. As part of the 

campaign rollout, an educational webinar was developed and offered 

which discussed the stockpile, hierarchy of controls and determinants for 

filling requests, education of SNS inventory management and ordering, 

and shipping information. These sessions were repeated five times to 

give hospitals/healthcare facilities ample opportunity to participate. 

Webinars were recorded and offered at later dates as well.” 

 “Additional fit-testing for different models took place. Because of the 

relative mildness of this pandemic, the workarounds were manageable 

but still time consuming when attention to other pressing clinical matters 

was needed. Had H1N1 been a more fatal disease, this issue would have 
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Association of State and Territorial Health Officials Page 84 

potentially been one of life-and-death circumstance.” 

Recommendations 

Suggested: 

Guidance 

A number of states recommended that CDC needs to improve its process for 

evaluating the science behind N95 versus surgical masks: 

 “CDC needs to take a more in-depth look into the need for N95s. 

HHS/CDC should implement a more streamlined process to evaluate 

and respond to these types of technical issues during an outbreak event.” 

 “Infection control measures/recommendations should match findings 

about the new virus, as suggested by SHEA, IDSA, and APIC. [The 

Society for Healthcare Epidemiology of America (SHEA), the Infectious 

Diseases Society of America (IDSA) and the Association for 

Professionals in Infection control and Epidemiology (APIC))]. Once it 

was discovered that the H1N1 virus was transmitted similarly to 

seasonal influenza, infection control recommendations should have been 

adjusted to match those of seasonal influenza.” 

 “Federal guidelines should be adjusted as new information and evidence 

becomes available.” 

 “Federal research needs to focus on providing an alternative to current 

N95 models; need to be easier to wear for longer periods of time. N95s 

with exhalation valves may be a better resource for now.” 

States found that CDC, OSHA/NOISH and the states need to define the 

distinctions and interplay among federal and state health and occupational 

directives. Consensus should be reached and publicized about which 

directives are mandatory and which are guidances only: 

 “Definitive guidance from OSHA is necessary. States and health care 

facilities need to know whether CDC guidance is truly just 

recommendations or regulations.” 

 “CDC’s infectious disease branch should work with NIOSH and OSHA 

to clarify and resolve how CDC recommendations interact with OSHA 

safety requirements. OSHA should clarify how it will handle hospitals 

and other institutions that follow their states’ worker protection 

recommendations if those recommendations conflict with CDC 

recommendations.” 

 “Clarify the relationship between NIOSH recommendations and OSHA 

safety requirements. Clarify interactions between federal law/guidance 

and state regulations. Clarify guidance for worker safety practices if 

official recommendations cannot be met (e.g., if the supply of N95 

masks is inadequate).”
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Association of State and Territorial Health Officials Page 85 

 “States need clarification whether OSHA will penalize 

hospitals/institutions that follow their states’ worker protection 

recommendations if they conflict with NIOSH or other federal guidance 

for worker safety.” 

 “Federal policies need to be clear to allow border states to work together 

at all levels, including infection control procedures and requirements. 

States also recommended that federal agencies need to consider the 

practical and implementation aspects of their directives/guidance on PPE as 

well as the science supporting it: 

 “Assuming that the scientific evidence continues to show that surgical 

masks are effective against transmission of flu, new guidance should 

recommend their use, given that N95s are significantly more expensive.” 

 “Recognizing that more data is always helpful, CDC should issue such 

policies like N95 earlier and take into account not only the available 

science, but also the realities of the supply situation.” 

 “The federal entities should work together ahead of an event to 

strategize on decision-making and realistic rules to be instituted in an 

emergency situation whether it is a mild communicable disease or 

something more severe. Develop a process that is timelier in an 

emergency situation.” 

 “Clarify respiratory protection policies early and ensure that necessary 

PPE is available to implement this guidance.” 

 “Policy-makers should make every attempt to realistically consider the 

full range of practical management implications involved in the process 

of providing health care for large numbers of individuals.” 

 “In the future, the federal guidance must weigh all of the available 

medical information as well as the practical and financial impact to the 

medical and public health systems.” 

 “The guidance regarding use of PPE from OSHA and CDC was clear, 

but not compatible, and practical obstacles to implementing CDC 

guidance arose in many settings. Better alignment between CDC and 

OSHA would reduce both confusion and legal risk for state and local 

health systems.”

In clarifying mask guidance, states recommended addressing the following 

key issues: 

 “Action items should include creating a list of activities N95 respirators 

should be reserved for, defining criteria for states to determine and 

declare a N95 shortage, and planning and estimating N95 respirators 

needed considering different priorities/situations.” 
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Association of State and Territorial Health Officials Page 86 

 “Federal survey should be conducted of the states to determine the 

preferred brands of assets used by hospitals; stockpile these in the SNS.”

 “Clarify guidance for worker safety practices if official 

recommendations cannot be met (e.g., if the supply of N95s is 

inadequate).” 

 “Guidance must consider alternate standards of care for PPE. Although 

the public health system should not plan to have insufficient numbers of 

respirators, contingency plans should be made if this is the case. The 

goal should be to always try to get more if there is a shortage, even if 

alternate plans exist to address a shortage.” 

Supply Issues/Shortages 

 “CDC and the states need to define what is meant by a ‘shortage’ of 

masks and its use as a trigger for releasing stockpiles and implementing 

protocols to deal with shortage conditions.” 

 “Federal contracts with PPE manufacturers should be strengthened to 

prepare for such supply chain disruptions during future public health 

emergencies.” 

 “Provide the SNS supply with various brands and sizes so that correct 

supplies can be shipped to healthcare facilities, enabling them to avoid 

having to re-fit test employees.” 

 “The CDC should survey the states to determine the brand preferred by 

hospitals in their hospitals, and stockpile these brands. 

 “FDA-approved respirators should be purchased without an expiration 

date, so they would not need to be released under an emergency use 

authorization.” 

 “CDC needs to inform states about the types of respirators that are 

stockpiled to ensure that personnel are fit-tested on the models that may 

be sent during a large-scale disease outbreak.” 

 “Various healthcare providers, including EMS, should enhance their 

current PPE stockpiles, including N95s.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 
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Association of State and Territorial Health Officials Page 87 

Emergency Use Authorizations (EUAs) 

[Note this section applies to all MCM (vaccines, antivirals, PPE, etc.)] 

Issue: C.10 Health care providers’ resistance to emergency use authorization 

(EUA) products may be limiting providers’ willingness to offer 

them to patients. Information supplied to patients with EUA 

products may not ensure that informed consent is obtained. 

Issue Type: Policy; Legal 

Level: Federal 

Discussion: Emergency Use Authorizations (EUAs) Generally

The H1N1 outbreak response represented the first time EUAs were 

authorized, and states generally found that the EUAs occurred quickly. The 

EUA web site was considered a useful resource by the states. Antiviral 

deployment, particularly under the EUA for intravenous Peramivir, was 

described by the states as having worked well. 

Provider Resistance to EUA Products 

An EUA allowed for the use of shelf-life extended drugs that were not 

relabeled. However, a respondent noted that “some clinicians refused to 

dispense these drugs.” States voiced the need to “conduct outreach to 

providers about the safety of dispensing drugs that had been shelf lifeextended though an EUA.” 

States cited “confusion over the interplay between the PREP Act and EUAs 

for labeling and dispensing of SNS antivirals as causing delays in their 

distribution.” 

Content and Format of EUA Patient Information Sheets 

State legal counsels noted that: “Information sheets provided to patients did 

not explain several facets of EUA drugs: (1) that the antiviral did not 

complete the standard FDA drug approval process; (2) liability protections 

provided by the PREP Act; and (3) processes for how patients can file for 

compensation for adverse effects.” State health agency attorneys are 

“concerned that patients may give consent without full disclosure, thereby 

raising a potential issue about whether the patient gave informed consent.” 

Agency counsel also raised questions about the impact of translating EUA 

patient information sheets. It was suggested that: “As long as the translation 

is consistent with the EUA it will not be considered a “change” to the 

content of the information, and therefore, will not be prohibited. Assuming 

that patient information sheets can be translated, counsel suggested that it 

would be more cost efficient and provide greater accuracy if the translation 

could be done at the federal level. The federal governments could translate 

the information sheet into more common languages rather than having each 

state translate the same information for the same languages and potentially 

reaching different translations.” 
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Association of State and Territorial Health Officials Page 88 

Mitigation 

Strategies 

Employed: 

 “The agency provided documentation of the Emergency Use 

Authorization and the FDA-approved fact sheets with each order the 

health agency shipped.” 

 “Placed the EUAs, fact sheets and guidance on the state’s web site and 

communicated this information on the health agency’s weekly webcasts 

to partners.” 

Recommendations 

Suggested: 

Emergency Use Authorizations (EUAs) Generally 

 “There should be national-level public messaging in lay terms to explain 

the ‘whats’ and ‘whys’ about EUAs.” 

 “Different outreach and information materials about EUAs are needed 

when targeting the public and health professionals.” 

Provider Resistance to EUA Products 

 “State and federal agencies need to reduce health care providers’ 

resistance to EUA products.” 

 “Better education for clinicians must take place regarding EUAs during 

an emergency.” 

 “Efficacy data should be supplied to reassure clinicians that they are 

providing a viable product.” 

Content and Format of EUA Patient Information Sheets 

 “Information supplied to patients with EUA products should be revised 

to ensure that informed consent is obtained.” 

 “Clarify that translation of EUAs are not prohibited under federal 

laws/regulations.” 

 “Patient information sheets should be translated into the more common 

languages by the federal government rather than by states.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 
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Association of State and Territorial Health Officials Page 89 

Medical Equipment Supplies and Tracking 

Issue: C.11 Alterations in the scope and frequency of HHS requirements for 

the National Hospital Available Beds for Emergencies and 

Disasters (HAvBED) System reporting caused frustration and 

confusion among states, hospitals and vendors. 

Issue Type: Policy 

Level: Federal 

Discussion: Alterations in the scope and frequency of HHS requirements for the National 

Hospital Available Beds for Emergencies and Disasters (HAvBED) System 

reporting caused frustration and confusion among states, hospitals and 

vendors. As one state remarked, “the HHS/ASPR requirement that hospitals 

submit HAvBED reports directly to HHS caused confusion about NIMS 

protocols for reporting to states and potentially lessened reporting of the 

information to states.”

 Changes in scope and frequency of reporting: States recounted that: 

“HHS repeatedly changed the scope (adding and changing a substantial 

number of new data elements and categories) and frequency of 

mandated HAvBED reporting, which impacted health care facilities and 

state health agencies. Failure to coordinate federal data requests with 

ongoing state and local data collection efforts created duplicative 

reporting requirements, or required reporting of slightly different data 

elements that increased the data collection burden for health care 

facilities. Facilities and HAvBED software vendors were impacted by 

having to change both the information queried as well as the frequency, 

and were therefore less likely to report their data. Local emergency 

medical services agencies (LEMSAs) and hospitals experienced 

frustrations in attempting to meet the moving targets, which also drove 

down reporting rates.” 

 Utility of reported data: In seeking data related to H1N1 response, HHS 

changed some of the data items to be collected through the HAvBED 

system. A respondent noted: “This compromised the ability to compare 

consistent data over time, required system changes, and provided data of 

limited utility. Moreover, although HHS permitted the use of 

supplemental H1N1 funding to support necessary system updates, HHS 

implemented the changes well after work plans and budgets for use of 

those funds had been finalized. By failing to work closely with state 

health departments, HHS collected data of limited situational awareness 

value.” 

 Direct reporting to HHS: Another state noted that: “HHS failed to work 

with state health departments to define and address situational awareness 
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Association of State and Territorial Health Officials Page 90 

needs, and sought to gather data directly from local health care facilities. 

HHS required hospitals to directly report to HHS about ventilator supply 

and availability. HHS also encouraged direct reporting to HHS about 

hospitals’ weekly HAvBED drills. This circumvented established 

response protocols as defined through NIMS and incident command, and 

created confusion about federal and state response roles. The federal 

government’s direct querying of local facilities also strained the 

relationship of state and local health and EMS agencies. Hospitals 

questioned why they were required to report this information to the state 

since they had already been asked to provide the information directly to 

the federal government. This resulted in potentially lower response rates 

to states’ HAvBED and other drill reporting.” 

Mitigation 

Strategies 

Employed: 

 “The HAvBED working group, formed by ASTHO, sent a letter and 

consensus documents, which were created in response to the new 

HAvBED data elements and consensus of operations (CONOPS) 

document, to HHS. The work group made recommendations on the 

HAvBED data elements and the CONOPS document, which contained 

both general comments as well as suggested revisions.” 

 One state agency “provided health care facilities with templates 

designed to make reporting easier.” 

 “Due to the inability of HAvBED software vendors to keep up with the 

changing requirements, one state agency used large numbers of agency 

staff who worked many hours on each HAvBED drill to manually enter 

data submitted by hospitals.” 

 “Health agency executive management worked directly with LEMSAs 

and state hospital associations’ leadership to identify issues, delineate 

the appropriate reporting relationships, and reduce confusion and 

friction associated with the federal reporting requests.” 

Recommendations 

Suggested:  “The federal government should follow established protocol for 

coordinating directly with states for hospital information.” 

 “HHS should work through states to collect this information from 

hospitals. HHS should identify a standard set of questions that would be 

applicable to a number of situations and not modify the questions or 

frequency of reporting.” 

 “HHS and the states should analyze data collected over the last year to 

determine if overall levels of preparedness have been affected by weekly 

versus monthly reporting of HAvBED data.” 

 “Incorporate a public comment period before introducing changes to 

HAvBED reporting requirements and data elements.” 
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Association of State and Territorial Health Officials Page 91 

 “Distribution of changes well in advance of mandatory reporting dates 

would give states time to implement the changes and minimize the 

impact on its partner LEMSA and health care facilities.” 

 “Per NIMS, the appropriate requesting route is for the federal 

government to make requests on ventilator or similar supply/availability 

information through designated state agencies. The states will request 

information of the appropriate LEMSAs or local health departments, 

which in turn collect the information from the appropriate facilities. 

Since states have drilled this reporting many times, this process can be 

done expeditiously.” 

 “The federal government should develop policies that clarify roles of the 

multiple response agencies and their responsibilities for data collection 

and support functions.” 

 “States should be allowed to monitor bed capacity and other resource 

issues on their own and provide federal partners with updates on a 

weekly basis.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

 
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Association of State and Territorial Health Officials Page 92 

III.D National Vaccination Campaign 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified 

The primary barriers identified related to the National Vaccination Campaign were (numbering does not

reflect a priority order for the barriers): 

D.1 Availability, Allocation and Prioritization–Delays in the production of the H1N1 

vaccine caused shortages as public demand for the vaccine peaked. 

D.2 Availability, Allocation and Prioritization–Delays in vaccine production and changing 

messages about their availability caused confusion among the public and hurt the 

credibility of governmental public health at all levels.

D.3 Availability, Allocation and Prioritization–Differing strategies used by states and 

localities for vaccinating priority groups and the general public caused confusion.

D.4 Ordering, Delivery and Distribution–Vaccine ordering systems were too complex and 

did not provide useful ways to manage ordering and delivery information. 

D.5 Ordering, Delivery and Distribution–Requirements for ordering vaccines in minimum 

dose counts required states to engage in additional distribution activities and further 

delayed delivery of vaccines to providers and localities. 

D.6 Ordering, Delivery and Distribution–Centralized state distribution systems for H1N1 

vaccines ran counter to some states’ existing immunization systems causing confusion 

and delay with providers and localities. 

D.7 Administering and Dispensing–States employed various strategies to expand the pool of 

eligible vaccinators, but state statutory limitations and a generalized fear of liability 

persists. 

D.8 Administering and Dispensing–School-based vaccination clinics, though an effective 

strategy to reach target populations, were limited by decentralized legal/policy authorities 

among education and health officials at the local level. 

D.9 Administering and Dispensing–Payment and reimbursement issues and systems for 

H1N1 vaccine administrations costs were slow to be addressed and must be improved. 

D.10 Tracking, Coverage, and Adverse Events Reporting–States encountered problems 

tracking H1N1 vaccines administered if they did not require mandatory reporting of 

vaccinations through state immunization registries. 

D.11 Tracking, Coverage, and Adverse Events Reporting–Better systems are needed for 

tracking vaccine uptake, coverage, recall and adverse events. 
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Association of State and Territorial Health Officials Page 93 

D.12 Recovery, Destruction and Disposal–States are concerned over the impending 

confusion and cost of recovering and disposing of expired H1N1 vaccine. 

Selected Successes/Mitigations Identified 

Vaccination Generally 

 “Vaccination efforts averted a third wave of H1N1.” 

 “State and local levels demonstrated excellent teamwork; new cooperative partnerships were 

established, using local health departments as coordinating centers for local health care providers, and 

supportive partnerships with local Chambers of Commerce assisted in the execution of a successful 

vaccine operation.” 

 “Additional successes included the value of the PREP Act in the dissemination of information, 

making health care workers a target group, and a high vaccination uptake reported in the Latino 

population.” 

Vaccine Identification and Formulations 

 “In less than a year, the federal government developed and delivered a vaccine for a novel influenza 

virus.” 

Vaccine Availability and Allocation 

 “Vaccines were available fairly rapidly (via weekly allocations).” 

 “The state credits the federal government for permitting state and local health officials to oversee and 

determine H1N1 vaccine allocation and distribution needs.” 

 “The state allocated a percentage of its vaccine allotment to the Tribal Nations. In addition to working 

with local public health departments, the state health agency coordinated distribution of the vaccine 

by working directly with IHS and tribal communities.” 

 States communicated as much as possible with partners. Some states used weekly webcasts to answer 

questions and provide information. Others set up nurse-staffed hotlines to handle concerns. States 

postponed public communication campaigns and rescheduled many public and school-based clinics. 

 One state health agency “used its communication channels and media to assist local county health 

departments in explaining the delay in vaccine and in maintaining public interest in obtaining 

vaccinations as they became available.” 

Vaccine Prioritization and Guidance 

 “There were pre-established, clearly defined priority policies for vaccination delivery and ordering.” 

 “Opening up vaccination in November to all community members markedly increased vaccination 

rates in the state.”

 In some states that targeted sub-priority groups first, “additional information was given to providers 

that the state was following sub-target groups’ recommendations, despite CDC national messaging 

about all target/priority groups.” 

 States also “tried to coordinate with local health departments on when to expand coverage uniformly 

within the state.” Some “waited until local public health and providers were nearly unanimous in 

saying they were ready to move to the general population and assuring that those that wanted to do 

school-based clinics had the vaccine to do so before vaccination was opened to all.” 
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Association of State and Territorial Health Officials Page 94 

 “The health agency encouraged local health agencies to work across jurisdictional boundaries in 

vaccinating priority groups and to realize that some groups would not get their vaccine in their county 

of residence. Many healthcare workers got the vaccine at their place of employment, which may have 

been different from their county of residence. Many pregnant women, especially those from rural 

areas, sought vaccination at their doctor’s office, which would likely not be in their county of 

residence. The state health agency encouraged all providers to follow the recommended priority 

groups and to realize that the overall goal was to vaccinate as many people as possible as quickly as 

possible. Therefore, if no priority group members needed or wanted the vaccine, the agency permitted 

vaccinators to offer the vaccine to other groups. As more vaccine became available and priority group 

needs were met, the state health agency changed the vaccine distribution algorithm to pro rata share 

based on population.” 

Minimum dose orders 

 One state “encouraged local health departments to work together to combine allocations into a single 

100-dose order, which was shipped to a single location and sub-distributed in a multi-county area.” 

 Another state “subdivided allocations for local health departments based on population.” 

 States stored some vaccine at the state level to make sure all providers, regardless of size, would have 

some vaccine. 

 States also reported “contracting with third-party distributors to allow shipment of less than 100-dose 

increments.” 

Vaccine Distribution and Supplies 

 “The national vaccine manufacturing and distribution process was seen as effective.” 

 “The quality of the federal vaccine supplies was adequate.”

 “The state health agency distributed vaccine to both providers and local health departments, with 

local health departments taking on the role of redistributors, allowed for sharing mechanisms between 

providers within a county.”

 “The state health agency provided local health departments with spreadsheets to inform them as to 

which providers in their jurisdiction were getting vaccine.”

 “In addition to working with local public health departments, the state health agency coordinated 

distribution of the vaccine by working directly with the Indian Health Service and tribal communities; 

the state health agency allocated a percentage of the state’s vaccine allotment to the Tribal Nations.” 

Administering Vaccine 

 “At the state and local level, public health agencies successfully provided H1N1 immunizations to a 

large number of people.” 

 “Recruiting additional community providers to facilitate vaccine administration, expanding 

pharmacists’ role in vaccinating patients ages 14+, as well as including paramedics to assist local 

health departments with vaccine administration were critical components in the success of the 

vaccination efforts.” 

 “Using Vaccines for Children [VFC] providers, school-based vaccination clinics, and direct shipment 

of vaccines to providers also facilitated vaccination efforts.” 

 “All healthcare providers who administered H1N1 vaccine were required to pre-register; preregistration was available online and accounted for the majority of enrollees.” 

 “The state drafted several draft executive orders to be implemented during a declared emergency, 

which orders expand public health authority to improve response. A few of these draft executive 
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Association of State and Territorial Health Officials Page 95 

orders delegate authority for vaccination to healthcare practitioners, such as EMS providers, that do 

not have this responsibility under their normal scope of practice. The state did not declare a state 

emergency and did not implement any of the draft executive orders. The state health agency and local 

public health agencies agreed that vaccinator-staffing shortages could be addressed on a case-by-case 

basis. At no time during the outbreak were additional vaccinators requested.” 

 “State health agencies communicated about state fiscal support for the cost of treatment/vaccination 

for the uninsured in weekly webcasts with local health departments, hospitals, etc.” 

Authority to Administer Vaccines 

 To address local emergency declaration requirements for using EMS as vaccinators, one state health 

agency reported “drafting guidance and working with all county EMS medical program directors to 

get the message out to counties on using this allowable change during an emergency. Because the 

vaccine came in slow and the disease was not severe this allowed this process to happen and 

personnel to register as emergency workers. Several counties did declare emergencies in order to use 

EMS staff to help vaccinate.” 

School-based Clinics 

 “Along with general vaccination marketing efforts, state and local health departments identified key 

members of the education leadership community to provide situational awareness and guidance to 

their respective entities and to encourage and support on-site vaccination.” 

 Partnerships in many school jurisdictions were developed, including K-12, community colleges, 

universities (student health) and university athletic associations. 

 Other states reported “engaging and collaborating with their states’ volunteer medical reserve corps to 

provide staffing at school-based clinics.” 

Vaccine Tracking/Recall/Adverse Events 

 “Reporting through Vaccine Adverse Event Reporting System (VAERS) and the state immunization 

registry were cited as beneficial systems utilized during the incident.” 

 “Manufacturers provided information directly to providers on recalled and expired vaccines which 

were helpful in the vaccination process.” 

 To mitigate the effects of not having mandatory reporting to the state immunization registry, one 

state: “Developed and implemented easy data entry options for the immunization registry to reduce 

the time needed to input the numbers of doses administered and extended automated data upload 

capabilities. In lieu of required reporting into the registry, the state also initiated a variety of methods 

to collect, compile, and authenticate data, including aggregate data reporting by some provider 

partners, as well as other surrogate sources of data.” 

 “To address temporary connectivity issues for pharmacy chains, local health departments input the 

required data entry into the immunization registry on behalf of the pharmacies.” 

 One state reported that: “Where possible, local public health staff administered vaccines in schoolbased clinics in order to avoid problems with FERPA and the associated problems with school 

employees reporting vaccinations to the state immunization registry. However, this was not possible 

in all areas.” 

 “The state reported successfully using poison control centers during the H1N1 response for such 

things as medical errors and adverse reaction reporting.” 
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Association of State and Territorial Health Officials Page 96 

Recovery, Destruction and Disposal 

 “The health agency has been working at the state level with the state’s environmental protection 

agency to sort through all these laws and identify a viable solution for local providers. The state has 

also been coordinating with CDC and BARDA to determine if the federal program will work in this 

state. If not, the state may need to take on the responsibility of ensuring proper disposal of expired 

H1N1 vaccine. 

Barriers/Recommendations Identified Detail 

Availability, Allocation and Prioritization of Vaccines 

Issues: D.1 Delays in the production of the H1N1 vaccine caused shortages as 

public demand for the vaccine peaked. 

D.2 Delays in vaccine production and changing messages about their 

availability caused confusion among the public and hurt the 

credibility of governmental public health at all levels. 

D.3 Differing strategies used by states and localities for vaccinating 

priority groups and the general public caused confusion. 

Issue Type: Policy 

Level: Federal; State 

Discussion: Vaccine Availability Estimates and Shortages 

States uniformly saw delays in production and the resulting shortages of 

H1N1 vaccine as a fundamental barrier to quick response, causing the 

inability to seize upon public interest to maximize the numbers vaccinated. 

One person captured the barriers as: “vaccine availability peaked when 

public concern/interest waned.” 

 Raising expectations: States acknowledged that the federal government 

is dependent on a vaccine manufacturing process that is outdated and 

dependent on private manufacturer’s capabilities. States noted that 

reliance on this system and “the erroneous and changing estimates of the 

amounts of vaccine available put states/locals in a difficult position.” 

Some states felt that, “given our nation’s system for vaccine production, 

the federal government should not have set the expectation that such 

large amounts of vaccine would be available so quickly.” 

 Delay/cancellation of vaccination clinics: Planned vaccine clinics had to 

be delayed or cancelled. State and local health departments were 

repeatedly faced with “hurry up and wait.” They had to get staff and the 

public ready for the arrival of vaccine which was repeatedly delayed. A 

number of states commented that “vaccination clinic efforts were not as 

effective because of shortages or a lack of vaccines for clinics.” One 
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Association of State and Territorial Health Officials Page 97 

person commented that “those turned away early on, when vaccine was 

limited, may never have returned when vaccine became readily 

available.” Other respondents suggested that “low vaccination levels 

may also be attributed to public perceptions that the vaccine had safety 

issues resulting in its delayed release/availability.” 

 Supplies directed to vaccination clinics: Some states noted that “federal 

recommendations to prioritize vaccine supplies to vaccination clinics 

interfered with state/local practices targeting vaccination through health 

care providers.” One state reported that: “State, local and health care 

entities were executing a series of plans to vaccinate the state’s most atrisk populations using hospitals, clinics and other direct providers. In 

complying with the federal recommendations from the White House and 

CDC urging states to publicize vaccination clinics, vaccine was diverted 

to local public health departments in quantities too small for them to 

open effective public clinics. As a consequence, local public health held 

onto resources that could have been more efficiently used within the 

health care provider system.” 

 Vaccine delay challenges: States also noted that: “Delays in vaccine 

availability resulted in messaging challenges for states and loss of 

credibility of public health with media, policymakers and the public. 

Seemingly futile efforts to vaccinate the population despite concerted 

efforts by immunization and other agency staff hurt employee morale. 

By the time there was sufficient vaccine, infection peaks had passed, the 

public lost interest, and vaccine supplies were not used.” 

Vaccine Allocation 

Some states viewed the allocation system as far too complicated; “an 

initially small number of variables increased significantly over time.” States 

reported that they “learned allocation amounts on a daily basis, impacting 

the amounts that could be distributed to providers, particularly because the 

CDC-estimated availability of vaccine was usually higher than actual 

allocations.”

States reported that “decision-making and communication to health care 

partners regarding quantity and timing of vaccine distribution was 

undependable” due to uncertainties about the amount and timing of vaccine 

available in the states. A respondent concluded that “this resulted in 

problematic ordering processes, lack of trust by the health care industry and 

local public health partners and ultimately, a slower and more confusing 

process for getting the public vaccinated.” 

Another state reported that: “Established vaccine allocation and distribution 

protocols between the federal government and Tribal Nations were not 

followed. The federal government has an established protocol for vaccine 

allocation and distribution to Tribal Nations. During the H1N1 response, the 

mandate to begin working with state and/or local health was problematic due 

to need to register their providers with the central distribution system.” 
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Association of State and Territorial Health Officials Page 98 

Although some states have “established collaborative relationships with the 

Tribal Nations, they were asked to circumvent an established process with 

the Indian Health Service (IHS) thereby creating a challenge for state and 

local public health departments to coordinate vaccination efforts.” 

Vaccine Formulation 

One state noted that “allocation of vaccine initially was very problematic 

due to public demand, target groups and injectable vaccine not available 

early on for those in target groups for whom the nasal spray was not 

indicated.” The state suggested that “rules tied to vaccine type (age; 

thimerosal-free; FluMist) limited vaccination of priority target populations 

when insufficient quantities of a particular type were received.” It was 

commented that “variety in vaccines (nasal spray – live attenuated, 

thimerosal-free, multi-dose with thimerosal, pediatric-specific) lead to public 

confusion and concerns about whether they were receiving the “right” 

(safest) vaccine.”

Prioritization and Guidance 

States likewise noted that the “disconnect between federal announcements of 

vaccination priority groups and state/local needs to broaden groups eligible 

for vaccination caused major uncertainty in the states.” A respondent 

commented that: “Targeting of high-risk groups created operational 

problems that included a need to screen people for eligibility; denial of 

vaccination to high-risk elderly individuals and family members of the target 

groups; complexity of administration; and difficult public information 

messages that created confusion.” As a result of tightly adhering to priority 

group categories and diminishing public demand, states were left with 

unused vaccine. 

 Conflicting direct messaging to providers: States noted that: “Direct 

communication from the CDC to health care providers promoting the 

administration of vaccines to people in the priority target groups when 

states were employing a sub-target group strategy caused confusion for 

providers regarding which guidance to follow and how to set up clinics. 

State agencies received a lot of calls requiring them to clarify the issue.” 

 Inconsistent prioritization for first responders: States also noted that the 

“failure to include all ‘first responders’ in Tier 1 [Editor’s note: Tier 1 

refers to ACIP H1N1 ‘initial target groups’] priority group caused 

confusion and ill-will among public responders and volunteers. While 

EMTs and other EMS personnel where included in Tier 1, other first 

responders such as law enforcement, fire, etc., were not. One respondent 

noted that: “As a result, public health took a lot of criticism from firstresponder groups that were not part of Tier 1. This may have damaged 

some existing professional relationships as those first-responders who 

were not part of Tier 1 took the issue personally and viewed it as 

minimizing their role in the response/society.” 
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Association of State and Territorial Health Officials Page 99 

It was noted that: “Compounding the situation was the fact that these 

groups were regarded as ‘essential services’ in past pandemic influenza 

planning efforts. This disconnect created confusion as to why they were 

not considered as ‘essential services’ during this particular ‘pandemic’ 

influenza outbreak.” One person observed that: “State health agencies 

tried to stand behind the CDC priority groups and explain the science 

behind the Tier 1 priorities as much as possible. Similarly, not allowing 

those in the SNS distribution network to get vaccinated ahead of time 

disrupted public health's relationship with those it needed for the 

mission.” One respondent concluded by saying that the “state fears they 

have lost the trust and respect of crucial volunteers, so much so that 

some may not volunteer in the future.” 

 Confusion between priorities in neighboring jurisdictions: Confusion 

occurred between neighboring jurisdictions that were targeting different 

priority groups and/or the general population. Some expressed that 

“there was a sense of unfairness among the public because they could 

not get vaccinated in their jurisdiction whereas similarly situated 

individuals could get vaccinated in other jurisdictions.” It was frequently 

noted that “individuals would cross jurisdictional boundaries trying to 

get vaccinated through another health department.” 

 Delays in guidance: States also noted that “delays in issuing vaccination 

guidance, as well as changing vaccination protocols and formulations, 

caused confusion with providers and required significant state health 

agency time to address and clarify.” It was viewed that “the lack of 

standard regarding when to expand vaccine coverage led to fragmented 

response strategies and confusion within the general population.” 

Mitigation 

Strategies 

Employed: 

Vaccine Availability Estimates and Shortages 

 States communicated as much as possible with partners. Some states 

used weekly webcasts to answer questions and provide information. 

Others set up nurse-staffed hotlines to handle concerns. States postponed 

public communication campaigns and rescheduled many public and 

school-based clinics. 

 One state health agency “used its communication channels and media to 

assist local county health departments in explaining the delay in vaccine 

and in maintaining public interest in obtaining vaccinations as they 

became available.” 

 Another state “launched an expansive multi-media campaign once 

vaccine supplies became adequate. This activity was minimally effective 

in encouraging individuals to seek out vaccination, as the public concern 

and overall media interest about the disease were waning.” 

 “Nationally, state health agency directors, ASTHO, and AIM petitioned 

to have promotional efforts delayed until a sufficient volume of vaccine 

was available for people who wanted it.” 
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Association of State and Territorial Health Officials Page 100 

Vaccine Allocation 

 To deal with initial shortages, some states further prioritized within the 

priority target groups to sparingly administer vaccine. However, the “use 

of 'sub-populations' early in the vaccination process caused even more 

confusion as to eligibility.” 

 One state placed “significant limits on the size and number of orders it 

filled for local health agencies and providers.” States had to “routinely 

substitute vaccine from different manufacturers rather than what 

providers had requested, depending on amount and type of vaccine the 

state received. This significantly slowed the process of vaccination.” 

 “Some local health officers did not want to use their vaccine supply, 

which was allocated based on their population, for outsiders. Health 

officers sought legal advice to be able to deny vaccine to individuals 

who do not live in their jurisdiction.” 

 “The state allocated a percentage of its vaccine allotment to the Tribal 

Nations. In addition to working with local public health departments, the 

state health agency coordinated distribution of the vaccine by working 

directly with IHS and tribal communities.” 

Prioritization and Guidance 

 State remedies for dealing with priority groups varied. In some states 

that targeted sub-priority groups first, “additional information was given 

to providers that the state was following sub-target groups’ 

recommendations, despite CDC national messaging about all 

target/priority groups.” 

 States also “tried to coordinate with local health departments on when to 

expand coverage uniformly within the state.” Some “waited until local 

public health and providers were nearly unanimous in saying they were 

ready to move to the general population and assuring that those that 

wanted to do school-based clinics had the vaccine to do so before 

vaccination was opened to all.” 

 “The health agency encouraged local health agencies to work across 

jurisdictional boundaries in vaccinating priority groups and to realize 

that some groups would not get their vaccine in their county of 

residence. Many healthcare workers got the vaccine at their place of 

employment, which may have been different from their county of 

residence. Many pregnant women, especially those from rural areas, 

sought vaccination at their doctor’s office, which would likely not be in 

their county of residence. The state health agency encouraged all 

providers to follow the recommended priority groups and to realize that 

the overall goal was to vaccinate as many people as possible as quickly 

as possible. Therefore, if no priority group members needed or wanted 

the vaccine, the agency permitted vaccinators to offer the vaccine to 
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Association of State and Territorial Health Officials Page 101 

other groups. As more vaccine became available and priority group 

needs were met, the state health agency changed the vaccine distribution 

algorithm to pro rata share based on population.” 

Recommendations 

Suggested: 

Vaccine Availability Estimates and Shortages 

 “Have one federal entity in charge of communicating supply 

information.” 

 “It would be better to be cautious in making projections rather than 

causing unrealistic expectations. Do not communicate unrealistic 

vaccine supply expectations.” 

 “Delay public communications about vaccine availability until sufficient 

supplies are available to engage in meaningful vaccination activity. 

Vaccine distribution on the mid-October target would have eliminated 

many of the problems experienced with the October 1 release 

announcement.”

 “Approve vaccine manufacturing technology improvements to more 

quickly produce vaccine for new flu strain. Until technology fixes are 

addressed, federal agencies need to improve their communication 

strategies and present realistic representations of vaccine availability to 

the public.” 

 “Federal, state and local agencies need to improve their ability to plan, 

organize, and communicate when production and delivery of the 

essential piece of the response strategy (i.e., sufficient vaccine) is 

outside of governmental control.” 

 “Vaccine should be ready for distribution when a national campaign 

effort goes into effect.” 

 “CDC needs to provide better projections on vaccine availability, 

demanding better estimates from vaccine manufacturers.” 

 “Vaccine manufacturers need to be held accountable for their estimated 

vaccine production.” 

Vaccine Allocation 

 “Explore ways to distribute vaccine by risk group when supplies are 

limited. Clarify sub-populations through the guidance process.” 

 “There should only be three types of vaccine available: FluMist, 

thimerosal-free for pregnant women, and one formulation for ages six 

months and above.” 

 “There is a need to determine if variations in availability among states 

and localities were from vaccination allocation or differences in 

implementation. If allocation is the problem, need to improve the 
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Association of State and Territorial Health Officials Page 102 

allocation methodology. If implementation differences are the problem, 

better coordination/identification of best practices should be pursued.” 

 “Consider employing state-level allocation for consistency or providing 

more direction from the state level regarding allocation. However, a 

state-driven approach is not always feasible, especially when funding 

and policy is directed at planning and coordination among all of the 

stakeholders on the local level to best meet the needs of local 

population.” 

 “There needs to be a clear delineation between the roles of federal, state 

and local governments. The recommendation to initiate local public 

health clinics is tactical and is best left as a discussion between the state 

and municipal entities. The federal government should concentrate on 

national strategic recommendations, but leave it to each state to identify 

the best local tactical response.” 

 “Review plans, policies and procedures for providing direct public 

health resources to Tribal Nations. Follow the established federal 

protocol for vaccine allocation and distribution to Tribal Nations.” 

Vaccine Formulation 

 “Limited vaccine formulation should dictate target group allocation.” 

 “The federal government should develop and communicate clear 

policies on the use of vaccine presentations.” 

 “There should only three types of vaccine available: FluMist, 

thimerosal-free for pregnant women, and one formulation for age six 

months and older.” 

Prioritization, and Guidance 

 “When using vaccine priority groups, provide guidance/identify triggers 

that detail when jurisdictions can expand beyond the priority groups.” 

 “Make recommendations for high priority groups, but do not restrict 

vaccination to those groups. Vaccinate anyone seeking vaccination; if 

supplies run out at a clinic, they run out. The vaccination campaign 

could still have been targeted by providing supplies first to those 

providers serving children, pregnant women and other high risk groups.” 

 “Further consideration of the status of EMT/EMS as Tier 1 priorities 

versus other first responders in establishing the priority groups for a 

national vaccination campaign. If necessary, amend the state response 

plans to have a tiered approach to vaccination/prophylaxis. Educate 

volunteers ahead of time regarding the tiered vaccination scheme so 

there are no surprises. Do not withhold advance vaccination from the 

SNS distribution team.” 
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Association of State and Territorial Health Officials Page 103 

 “The CDC needs to take the states’ views and vaccine supplies into 

consideration when developing material. States have seen/experienced 

similar problems with seasonal influenza when vaccine availability is 

painted with a broad brush.” 

 “Policy should be developed to include laboratory staff as health care 

workers.” 

 “The federal government should develop policies regarding service 

delivery to undocumented workers while they are in the U.S.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Vaccine Ordering, Delivery and Distribution 

Issues: D.4 Vaccine ordering systems were too complex and did not provide 

useful ways to manage ordering and delivery information. 

D.5 Requirements for ordering vaccines in minimum dose counts 

required states to engage in additional distribution activities and 

further delayed delivery of vaccines to providers and localities. 

D.6 Centralized state distribution systems for H1N1 vaccines ran 

counter to some states existing immunization systems causing 

confusion and delay with providers and localities. 

Issue Type: Policy 

Level: Federal; State 

Discussion: Vaccine Ordering Concerns 

 Ordering systems: State reported: “Using immunization systems 

(VacMan) for ordering and tracking vaccine allocation and delivery was 

complex, time intensive and required extensive training to use. The 

intricacies of setting up providers and entering the orders were too 

complex making it difficult to have people without in-depth system 

experience perform the functions causing significant drain on staff 

trained on the system.” 

One agency found that: “There was no way to define the priorities of 

order fulfillment based on vulnerable populations and other factors. 

There was no way to track order backlogs, orders vs. shipments, or 

transfers of vaccine by providers. The system is not able to be replicated 

within a single jurisdiction and was not co-located with public health 

emergency preparedness staff that was responsible for allocation of the 
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Association of State and Territorial Health Officials Page 104 

vaccine, management of the mass immunization clinics and the overall 

H1N1 response including messaging, coordination with healthcare and 

immunization providers, etc.” 

Another state reported that: “The state could not give local health 

departments accurate information about expected vaccine deliveries. As 

a result, local health departments felt inhibited in their ability to 

schedule vaccination clinics without knowing for certain when and how 

much vaccine they would receive. Some counties received large supplies 

while other counties received none or little of their supplies, which 

initially caused confusion among local health departments and the 

public.” 

 Minimum dose-count orders: One respondent captured a frequently 

identified barrier by the states: “CDC/McKesson’s decision not to 

direct-ship vaccine allocations less than 100 doses to providers caused 

an immediate problem.” States noted that: “Providers needing less than 

100 doses/shipment had to wait longer to receive shipments. This 

created inequity among larger and smaller volume providers since state 

agencies were not initially able to supply vaccine to all providers. This 

created frustration/panic in parents. This requirement also forced some 

states to implement programs with local distributors who may not have 

been fully prepared for frequency of vaccine distribution/delivery.” 

In states with smaller populations and very limited vaccine allocations, 

respondents noted that “it was impossible for many providers to order 

vaccine in 100-dose increments when the vaccine first became 

available.” In these instances, some states “had to warehouse vaccines 

and brake down orders into smaller increments to ship or drive them out 

to healthcare providers.” Yet it was noted that “this required significant 

staff time and funding, caused storage and handling issues for the 

vaccine, and caused a delay in providers receiving the vaccine.” 

Vaccine Delivery and Distribution Concerns 

 Differing agency distribution criteria: One state commented that: 

“Independent agencies that received vaccine used different criteria to 

distribute H1N1 vaccine. Some agencies used local health department 

resources exclusively, while others used pharmacies and health care 

providers. This caused public confusion as to where and how to receive 

an immunization. Once the federal pharmacy distribution program 

started, public confusion and frustration grew as large chains were seen 

as competing for vaccine supplies with local agency clinics.” 

 CDC NCIRD vs. DSNS distribution: One state captured a perceived 

“continued lack of coordination between NCIRD and other divisions at 

CDC, especially DSNS, and the controlling role that NCIRD played in 

vaccine distribution”, as a barrier experienced by the states. The state 

commented that: “DSNS is the primary force in public health 
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Association of State and Territorial Health Officials Page 105 

preparedness and countermeasure distribution at the state and local level 

and its mission and work parallels the National Response Framework 

and NIMS. State and local governments have developed plans for 

distribution of SNS supplies and other countermeasures.” The 

respondent felt that “NCIRD maintained control of the H1N1 

vaccination campaign, and ...its initial internal logistics work was 

impressive (implementation of a robust distribution system);” however, 

the respondent believed more guidance was needed on “rapid and 

equitable ordering, distribution, and allocation of vaccine.” The 

respondent concluded: “This resulted in state immunization programs 

attempting to distribute vaccine outside of the state and local response 

plans. These issues complicated the vaccination campaign as many of 

the established state and local roles and responsibilities, communication 

channels and response systems were set aside in favor of developing a 

new state-centric distribution system.” 

Another state discussed challenges with vaccine ordering: “Significant 

time and resources were spent setting up complex pre-booking, order 

verification, and allocation systems that mirror the VFC system but are 

not appropriate for rapid, equitable vaccine distribution. Local health 

departments and providers were assigned random numbers that 

determined the order of filling their orders; however, this weeks-long 

process coupled with slowed vaccine production resulted in very uneven 

distribution. The complexities and gaps of the ordering system resulted 

in many erroneous orders and too much variance in the time that 

providers, and even geographic regions, received initial doses. The 

centralized ordering and distribution system did not give local health 

departments or tribes the authority that had been planned for in a mass 

prophylaxis response.” 

 Centralized vaccine distribution: Some states noted that “federal plans 

for centralized control over vaccine distribution placed a heavy 

administrative burden on state public health agencies to recruit willing 

providers, allocate scarce vaccine, and manage the distribution process.” 

This was, however, seen as: “An improvement over the initial federal 

plan to send vaccine only to the states for public health to administer or 

distribute. By circumventing the usual practice in which providers order 

their supplies directly from their suppliers or the manufacturers, the 

distribution process made it necessary to contract for an expensive 

federal vaccine storage and distribution system and required state 

bureaucracy to allocate and control distribution of vaccine and supplies. 

This drew state resources away from planning and implementing the 

vaccination campaigns.” 

Supply Chain Visibility and Inventory Management 

Visibility of the location and inventory of public and private supplies of 

vaccines was identified as important data for state/local allocation decisionmaking. It was commented that: “State and local health departments did not 

have complete information on which to base vaccine allocation decisions. 

Frequent system difficulties and crashes, requiring additional hours and 
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Association of State and Territorial Health Officials Page 106 

repeated ordering, delayed ordering and shipment.” 

Several states raised questions about the ownership of H1N1 vaccines after 

they have been distributed, including what the states may and may not use 

excess vaccines for. (See also discussion of this issue in the Medical Care 

and Countermeasures section) 

Mitigation 

Strategies 

Employed: 

Vaccine Ordering Concerns 

 Ordering systems: States “tried to mitigate the burden of using the 

ordering system by delegating non-VacMan related duties to other staff, 

yet this did not result in efficient processes.” One agency noted that “in 

order to overcome severe staff shortfall on such short notice, they 

requested additional support from CDC to assist in the data entry 

process into VacMan.” 

 Minimum dose-counts: States had to develop and employ alternate 

distribution strategies to deal with orders for less than the minimum dose 

count. One state “encouraged local health departments to work together 

to combine allocations into a single 100-dose order, which was shipped 

to a single location and sub-distributed in a multi-county area.” Another 

state “subdivided allocations for local health departments based on 

population.” States stored some vaccine at the state level to make sure 

all providers, regardless of size, would have some vaccine. States also 

reported “contracting with third-party distributors to allow shipment of 

less than 100-dose increments.” However, “because of slow state 

contracting processes, the contracts were delayed, which exacerbated the 

issue.” 

Vaccine Delivery and Distribution Concerns 

 CDC NCIRD vs. DSNS distribution: “Several local health departments 

opted out of the primary vaccine ordering and distribution system in 

order to manage the vaccine distribution within their counties. Among 

local health departments that remained with the centralized distribution 

system (providers placed orders with the state, and vaccine was shipped 

directly to the providers), over 90% still coordinated or assisted with 

redistribution between providers, using local time and resources. Many 

local health departments shared with neighboring health departments in 

order to vaccinate priority groups and work around the random number 

system.” 

Recommendations 

Suggested: 

Vaccine Ordering Concerns 

Ordering system: 

 “Develop a new, more highly functional system (which in the process of 

being done by the CDC and a contractor).” 

 “In the future, additional funding should be incorporated into federal 

immunization grants requiring training of additional personnel, 

including public health emergency preparedness staff, on using the 
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Association of State and Territorial Health Officials Page 107 

current and new vaccine ordering system to ensure that during an 

emergency requiring vaccine there is not a lengthy start-up time to 

compensate for the dramatic increase in workload.” 

Minimum dose-counts: 

 “In the future, CDC should be more flexible with vaccine shipment 

allocations.” 

 “Allow for states to order vaccine shipments in smaller than 100-dose 

counts. Consider 50-, 25- or 10-dose increments.” 

Vaccine Delivery and Distribution Concerns 

CDC NCIRD vs. DSNS distribution: 

 “CDC needs to distribute all countermeasures (including vaccine) out of 

one division, or at a minimum select an appropriate lead division. The 

appointed division needs to be well-versed in emergency preparedness, 

national systems and frameworks, all elements of supply-chain logistics 

in a biological response, and the ability to provide helpful guidance to 

states.” 

Centralized vaccine distribution: 

 “An approach that follows normal distribution channels could have been 

used, with the initial limited supplies sent to the public health 

departments and identified priority vaccination providers (i.e. those 

participating in VAFAC). This approach would have allowed all willing 

providers to participate without requiring them to go through 

unnecessary bureaucratic hoops. Use normal vaccine distribution 

channels as much as is feasible, so that providers do not have to do 

unusual things to get vaccines and public health departments are not 

forced to serve as middle-men in the distribution process.” 

Supply Chain Visibility and Inventory Management 

 “Establish guidance on the benefits and most appropriate course of 

action regarding maintaining state-based stockpiles of residual H1N1 

vaccine for possible future use.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 
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Association of State and Territorial Health Officials Page 108 

Administering and Dispensing Vaccines 

Issues: D.7 States employed various strategies to expand the pool of eligible 

vaccinators, but state statutory limitations and a generalized fear 

of liability persists. 

D.8 School-based vaccination clinics, though an effective strategy to 

reach target populations, were limited by decentralized legal/policy 

authorities among education and health officials at the local level. 

D.9 Payment and reimbursement issues and systems for H1N1 vaccine 

administrations costs were slow to be addressed and must be 

improved. 

Issue Type: Policy; Legal 

Level: State, Federal 

Discussion: Authority to Administer Vaccines 

States took various approaches to authorizing nonmedical professionals to 

administer vaccinations. Some states noted that “public health built and/or 

expanded wide-ranging partnerships to immunize people, including with 

pharmacies; physicians; clinics; hospitals; medical and professional 

associations; schools; colleges and universities; Medical Reserve Corps 

(MRCs); community and faith-based organizations (CFBOs); tribes; and 

others.” Expanding the pool of vaccinators was important in all states, but 

“especially in those states with insufficient state and/or local public health 

workforce capacity to execute a statewide initiative for school-based flu 

vaccination clinics.” 

One home-rule state, in which local health directors have the authority to 

declare public health emergencies, noted that: “EMS can only act as 

supplemental vaccinators if an emergency declaration is in place. Some 

categories of EMS personnel are trained to give injections, but may only 

give vaccinations under certain criteria, which includes a state or local 

declaration of emergency and being registered as an emergency worker 

under state law. Many jurisdictions do not have sufficient personnel in their 

county to run mass vaccination clinics and must rely on other sources to 

accomplish this task in an emergency. If a jurisdiction has not pre-planned 

this or is hesitant to declare an emergency for other reasons this limits 

immediate response in an emergency situation.” 

Another strategy being considered by states for expanding the pool of 

vaccinators was to “qualify school nurses as public health employees to 

administer vaccines.” Having “MOUs in place to qualify school nurses as 

public health agency employees” was identified as a potential strategy to 

alleviate school nurse liability concerns. (See related issue in the “Tracking” 

section below.) 
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Association of State and Territorial Health Officials Page 109 

School-based Clinics 

School-based clinics were seen as effective ways to vaccinate children. One 

state reported that “holding H1N1 vaccination clinics in schools and during 

school hours allowed some localities to capture a large percentage of target 

groups.” In that state, “one quarter of its counties immunized children in 

schools and reached nearly 60% of the target groups immunized in those 

counties.” 

However, states also noted: “Decentralized legal/policy authorities among 

education and health officials at the local level reduced the potential 

effectiveness of school clinics to maximize the numbers of children 

vaccinated. Despite coordinated efforts among state and local health 

departments and their state and local education counterparts to implement 

school vaccination clinics, a number of local school districts (including large 

metropolitan areas) chose not to conduct vaccination campaigns in their 

schools.” 

States identified several common concerns about school vaccine clinics, 

including “how to increase vaccine uptake, particularly LAIV, and how to 

overcome administrative hurdles such as staffing, consent forms, and 

managing second doses.” One state noted that “among the biggest successes 

were school clinics and the vaccination of pregnant women.” 

Vaccination Clinics Generally 

States frequently noted that “delays in vaccine production and distribution 

hindered the ability of state and local governments to conduct timely and 

effective H1N1 vaccination clinics. Some also noted that “delays in 

developing the provider agreements stalled efforts to hold clinics and 

otherwise expand the pool of vaccinators.” Several agency counsels noted 

that “outstanding questions persist regarding liability coverage under the 

PREP Act and other laws, and under what conditions different health care 

providers can act as vaccinators.” 

One state commented that: “State and local health departments were told that 

the U.S. Department of Defense (DOD) would be vaccinating their own 

personnel; however the DOD did not receive vaccine in time to vaccinate 

their personnel prior to or during the peak of the outbreak. Local health 

departments could vaccinate dependents of active duty personnel, but not 

active duty personnel themselves– including those that were pregnant or had 

other high-risk conditions.” 

Payment and Reimbursement 

States found that “payment and reimbursement issues and systems for H1N1 

vaccine administration costs were slow to be addressed and must be 

improved.” States noted that “as PHER funding phases out, third-party 

payers will be needed to help continue vaccination services and vaccine 

uptake.” A respondent commented that “business processes must be 

revamped and simplified to allow more efficient third-party billing to 

insurers to recover allowable costs for the administration of the vaccine.” 
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Association of State and Territorial Health Officials Page 110 

State insurance laws do not mandate the coverage of vaccines during 

declared public health emergencies. 

States identified the need to “reduce/remove barriers such as vaccine 

administration co-payment and administration fees, which were clearly 

identified as conditions impeding vaccine uptake of and coverage rates of atrisk populations.” Some states reported delays in “state-provided fiscal 

support for cost of H1N1 treatment/vaccination for the uninsured.” Once this 

benefit was in place, “there was a lack of adequate publicity to reach out to 

covered persons.” 

Mitigation 

Strategies 

Employed: 

Authority to Administer Vaccines 

 To address local emergency declaration requirements for using EMS as 

vaccinators, one state health agency reported “drafting guidance and 

working with all county EMS medical program directors to get the 

message out to counties on using this allowable change during an 

emergency. Because the vaccine came in slow and the disease was not 

severe this allowed this process to happen and personnel to register as 

emergency workers. Several counties did declare emergencies in order 

to use EMS staff to help vaccinate.” 

School-based Clinics 

 “Along with general vaccination marketing efforts, state and local health 

departments identified key members of the education leadership 

community to provide situational awareness and guidance to their 

respective entities and to encourage and support on-site vaccination. 

Partnerships in many school jurisdictions were developed, including K12, community colleges, universities (student health) and university 

athletic associations. Other states reported engaging and collaborating 

with their states’ volunteer medical reserve corps to provide staffing at 

school-based clinics.” 

Payment/Reimbursement 

 “State health agencies communicated about state fiscal support for the 

cost of treatment/vaccination for the uninsured in weekly webcasts with 

local health departments, hospitals, etc.” 

Recommendations 

Suggested: 

Authority to Administer Vaccines 

 “Federal and state officials should review and assess the various 

approaches states took to authorize nonmedical professionals’ to 

administer vaccinations, including modifying state licensing 

requirements during an emergency.” 

 “Plans should be reviewed and possibly revised regarding expanding the 

use of pharmacists as vaccinators in future planning efforts for pandemic 

response.” 
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Association of State and Territorial Health Officials Page 111 

 “Participants desired a clear policy on the roles of pharmacists 

(when/what they can be used for) during an incident.” 

 “State health agencies should continue to work with counties and EMS 

to recommend registering this type of personnel as emergency workers 

and educate county leadership on when and how to declare an 

emergency for that specific purpose. Anything from the federal 

government that supports expanded roles for EMS in declarations or 

guidance will assist the states.” 

 “The state health agency will continue to provide the existing legal 

guidelines defining what different classes (EMT-B, EMT-I, etc.) of 

EMT’s can do under specific circumstances during a declared vs. nondeclared disaster.” 

 “State should develop policies for practice standards of non-traditional 

vaccinators/dispensing practitioners for use during an emergency.” 

 “State should improve interagency cooperation especially with the nontraditional responder community to develop policies real-time during an 

incident. This non-traditional responder community includes agencies 

that have a regulatory function.” 

 “State should develop policy standards for local agencies regarding 

policies that allow emergency certifications or expansion of practice for 

professionals and liability protection. Local governments should develop 

policies that enable professionals who are not health department staff 

assist with expanded roles as provided by state policy.” 

School-based Clinics 

 “Due to the local authority/autonomy of school districts in some states, 

promotion of school-based vaccination programs through joint health 

and education efforts and coalitions is the best course of action.” 

 “Coordinate and plan with state public health preparedness programs, 

state immunization programs, and school districts to fund and train 

school nurses and personnel to immunize their student populations in the 

future. Exercise plans created with seasonal flu vaccine or other 

identified vaccines provided by state 317 funds.” 

Vaccination Clinics Generally 

 “The role(s) of public health in vaccination efforts needs to be defined 

and the efficacy of using school-based clinics, local health department 

clinics, hospitals and clinics, and other venues should be evaluated, with 

recommendations communicated to states.” 

 “U.S. DoD needs to provide vaccine to all military personnel as 

promised in a timely fashion or enable state and/or local health 

departments to vaccinate military personnel with financial and 
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Association of State and Territorial Health Officials Page 112 

operational support from DoD.” 

Payment/Reimbursement 

 “State insurance laws should mandate the coverage of vaccines during 

declared public health emergencies.” 

 ”Provide recommendations surrounding cost-reimbursement issues prior 

to vaccine distribution to enable state/local health departments to plan 

accordingly.” 

 “Provide states with total, unrestricted funding amounts prior to vaccine 

distribution to allow public health agencies to anticipate immunization 

administration fees.” 

 “The federal government should develop and communicate clear 

policies regarding the use of federal grant funds that can be used for 

operations and the intersection of the uses and other reimbursement 

programs (such as Medicare and Medicaid).” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Tracking, Coverage, and Adverse Events Reporting 

Issues: D.10 States encountered problems tracking H1N1 vaccines 

administered if they did not require mandatory reporting of 

vaccinations through state immunization registries. 

D.11 Better systems are needed for tracking vaccine uptake, coverage, 

recall and adverse events. 

Issue Type: Policy; Legal 

Level: State; Federal 

Discussion: Tracking Vaccinations Administered 

States reported a number of challenges in 

 Reporting vaccinations: It was observed that: “States that failed to 

require all public and private providers that received H1N1 vaccine to 

report their doses-administered data through the state immunization 

registries encountered a variety of problems related to tracking and 

accountability of vaccine administration and populations served. This 

led to incomplete data and inefficiencies in collecting information that 

was later requested for national reporting. Additionally, lack of 

consistent reporting of doses administered into the state immunization 

registry limited information regarding the total population protected. In 

significant disease outbreaks, it is critical to determine the population 
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Association of State and Territorial Health Officials Page 113 

most susceptible (e.g., ensure that the at-risk population may be 

distinguished from the protected population). Such efforts cannot be 

done well without accurate centralized reporting of doses administered.” 

In some states, health agencies are legally required to seek consent from 

individuals before their vaccination data can be entered into the state’s 

immunization registry (“opt-in” systems). States using this system noted 

that “the opt-in type of system placed an enormous burden on states 

using their state immunization registry as the tool for tracking doses 

administered.” It was believed that “states with ‘opt-out’ or mandatory 

systems were more effective tools for tracking H1N1 vaccinations.” 

One state that did mandate that H1N1 providers use the state-wide 

immunization registry to track doses administered reported that: 

“Several pharmacies had technical issues with connecting to the statewide immunization registry because of internal corporate policies that 

forbade access to Internet systems outside of corporate Intranets. There 

was considerable lag-time that pharmacies had to deal with while these 

technical issues were addressed. This lag-time prevented pharmacies 

from offering H1N1 vaccines for several weeks while these pharmacies 

dealt with these connectivity issues.” 

 School-based clinics and FERPA: During the H1N1 outbreak, questions 

and uncertainties persisted regarding the ability of school-based clinics 

to report vaccinations to state immunization registries due to Family 

Educational Rights and Privacy Act (FERPA) concerns. States explored 

“qualifying school nurses as public health employees to administer 

vaccines and report immunizations.” It was thought that “by having 

MOUs in place to qualify school nurses as public health agency 

employees this was seen as a potential way to alleviate liability concerns 

and authorize them to report immunizations.” 

 Veterans Administration: One state commented that: “The federal 

Veterans Administration prohibited individual doses-administered data 

from being entered into statewide immunization registries. This resulted 

in incomplete records on individuals, inability to follow on adverse 

events, and the inability to fully evaluate the H1N1 vaccination 

program.” 

Vaccination Coverage 

 Improving health care coverage rates: States voiced a desire to “see a 

concerted effort to improve vaccine acceptance among health care 

providers to increase vaccine coverage rates of health care workers.” 

 Uptake and coverage data/monitoring: States observed that: “There was 

limited vaccine uptake and coverage data to guide local public health 

efforts. Monitoring doses administered was problematic. A better system 

is needed for tracking, including obtaining more robust and useful data 

from private sector providers.” 
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Association of State and Territorial Health Officials Page 114 

Adverse Event Reporting 

Having a better system to track when vaccinations are administered was 

identified as crucial for determining if vaccinees are having adverse effects 

related to the vaccine. 

Vaccine Recall 

A state commented that: “CDC recalled vaccine during the outbreak due to 

degrading vaccine, quality, expiration dates, etc. When the public hears the 

word ‘recall’, they believe something is wrong—that the vaccine is 

dangerous. The use of the word ‘recall’ can lead to people refusing to be 

vaccinated due to misinformation.” 

Mitigation 

Strategies 

Employed: 

Tracking Vaccinations Administered 

Reporting vaccinations: 

 To mitigate the effects of not having mandatory reporting to the state 

immunization registry, one state: “Developed and implemented easy 

data entry options for the immunization registry to reduce the time 

needed to input the numbers of doses administered and extended 

automated data upload capabilities. In lieu of required reporting into the 

registry, the state also initiated a variety of methods to collect, compile, 

and authenticate data, including aggregate data reporting by some 

provider partners, as well as other surrogate sources of data.” 

 “To address temporary connectivity issues for pharmacy chains, local 

health departments input the required data entry into the immunization 

registry on behalf of the pharmacies.” 

School-based clinics: 

 One state reported that, “Where possible, local public health staff 

administered vaccines in school-based clinics in order to avoid problems 

with FERPA and the associated problems with school employees 

reporting vaccinations to the state immunization registry. However, this 

was not possible in all areas.” 

Veterans Administration: 

 “The health agency reported contacting the VA with a letter seeking 

their participation in the registry for the H1N1 data. A reply has not been 

received yet.” 

Adverse Event Reporting 

“The state reported successfully using poison control centers during the 

H1N1 response for such things as medical errors and adverse reaction 

reporting.” 
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Association of State and Territorial Health Officials Page 115 

Recommendations 

Suggested: 

Tracking Vaccinations Administered 

Reporting vaccinations: 

 States offered several suggestions for improving vaccination reporting 

through immunization registries. “States with opt-in systems should seek 

to change their state law to either a mandatory or opt-out system.” 

 “All providers participating in a pandemic influenza vaccine campaign 

should be required to use the statewide immunization registry for 

reporting vaccine accountability data as a matter of policy. This could be 

made a condition of acceptance of vaccine by providers.” 

 “States should work with pharmacies and other private providers with 

restrictive Internet security policies that preclude access to state 

immunization registries to remove this barrier. States need to increase 

the functionality and interoperability of electronic immunization 

registries to track and monitor vaccinations.” 

School clinics: 

 The U.S. Department of Education issued guidance on FERPA and 

H1N1 issues in October 2009. “States need to evaluate the guidance to 

determine if it satisfies the questions they have about FERPA and 

whether it makes it easier to track H1N1 vaccines administered at 

school-based clinics.” 

Veterans Administration: 

 “Changes are needed in federal policy/practice that prohibits VA 

participation in state immunization registries.” 

Vaccination Coverage 

 To further expand vaccination coverage rates among health care 

workers, “states should investigate potential partnerships with large 

HMOs to capitalize on their approach and track records in positively 

influencing physician beliefs and behaviors.” 

 “States should evaluate the effectiveness of lowering patient age for 

vaccination to increase the reach of an expanded pool of authorized 

vaccinators. Federal and state staffs need to (1) assess the impact of the 

varying patient age requirements and limitations on the authority to 

administer influenza vaccines among states; and (2) assess the related 

impacts in states that issued emergency orders lowering the allowable 

age for the express purpose of increasing vaccination coverage. These 

assessments will inform future decisions and possible reform and 

national harmonization of this public safety requirement.” 

Adverse Event Reporting 

 “Vaccine tracking systems must be enhanced to monitor for adverse 
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Association of State and Territorial Health Officials Page 116 

reactions.” 

Vaccine Recall

 “CDC should never use the word ‘recall’ in association with vaccine 

unless there is a clear safety issue.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Recovery, Destruction and Disposal 

Issue: D.12 States are concerned over the impending confusion and cost of 

recovering and disposing expired H1N1 vaccines. 

Issue Type: Policy; Legal 

Level: State; Federal 

Discussion: States expressed concern regarding the “potential costs and lack of guidance 

regarding proper recovery and disposal of vaccines.” It was noted that 

“states and providers with expired vaccine are facing potential costs to 

establish contracts to dispose of vaccine.” 

The treatment of expired vaccines as “hazardous waste, medical waste (or 

some other classification required by state law) will have significant 

implications for states’ recovery activities and potential disposal costs for 

public and private providers as each has separate disposal requirements.” 

In one state with environmental laws that are more restrictive than federal 

laws, it commented that “There are multiple categories of waste defined by 

statute/regulation (e.g., dangerous waste, state-only dangerous waste, dual 

waste, pharmaceutical waste, RCRA hazardous waste). Only certain entities 

are allowed to collect and dispose of some categories of waste as defined in 

state law and the disposal process is very confusing and cumbersome. 

Depending on how the expired vaccine is classified, local health agencies 

may not be allowed to act as a collection point. Even some commercial 

collectors who dispose of their waste in other states may not be allowed to 

be used.” 

It was noted that “many of the providers who gave H1N1 shots do not 

typically handle items that are classified in ways that cannot be disposed of 

through sharps’ containers or similar processes.” Another potential concern 

is that “providers who volunteered to assist with H1N1 vaccinations, but 

who might not typically vaccinate, may not volunteer again due to the hassle 

of disposal of these assets.” 
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Association of State and Territorial Health Officials Page 117 

Mitigation 

Strategies 

Employed: 

 “The health agency has been working at the state level with the state’s 

environmental protection agency to sort through all these laws and 

identify a viable solution for local providers. The state has also been 

coordinating with CDC and BARDA to determine if the federal program 

will work in this state. If not, the state may need to take on the 

responsibility of ensuring proper disposal of expired H1N1 vaccine. 

With the potential for funding to help pay for the disposal ending July 

30, 2010, states need to get this issue resolved.” 

Recommendations 

Suggested:  “The creation of a demobilization plan that thoroughly addresses the 

many logistical and financial issues around disposal of vaccine was 

identified as a high priority for many states. This plan should include 

identifying a funding source to cover the attendant costs, especially if 

this will take place after July 30th when PHER funds are expected to 

terminate.” 

 “States would prefer materiel be classified as medical waste because the 

cost associated with disposal will be less than if it is deemed “hazardous 

waste.” Further recommendations from the state representatives included 

consistent labeling across states; medical or hazardous waste; use Public 

Health Emergency Response (PHER) carry-forward funds to store or 

centralize vaccine that will not expire; and using PHER funds to 

recollect vaccine.” 

 “Expired or non-viable vaccine should be able to be returned to the 

manufacturers or the distributor for proper disposal.” 

 “Since government supplied vaccines and materials for free, the 

administration fee that providers collected giving the vaccine was meant 

to cover disposal costs, too.” 

 “Vaccines need to be designated so that states that have strict 

environmental rules know which category these products fall into. When 

not designated, they automatically fall into stricter category in some 

states, thereby requiring a more complicated disposal process.” 

 “It is recommended that CDC proactively work with other federal 

agencies to ensure disposal options are addressed at the front end of a 

response. This will likely be an issue for antivirals in the future 

especially if they are not designated under the environmental rules yet.” 

[Sources: Survey: X Meetings: Environmental Scan: X ] 

 
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Association of State and Territorial Health Officials Page 118 

III.E Workforce, Capacity, and Infrastructure 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified 

The primary barriers identified related to workforce, capacity and infrastructure were (numbering does 

not reflect a priority order for the barriers): 

E.1 Public Health Workforce Surge Capacity–Flexing and surging the public health 

workforce was a challenge, especially as repeated rounds of budget cuts and hiring 

freezes have shrunk standing capacity in state health agencies. 

E.2 Health Care/Medical Surge–Surge capacity in the health care sector is limited and 

could be quickly overwhelmed during a prolonged pandemic event.

E.3 Volunteer Surge Capacity–Volunteers participating in the H1N1 response expressed 

fears about their potential legal liabilities during the response. 

E.4 Volunteer Surge Capacity–Volunteers provided important surge capacity to the H1N1 

response, but they are not appropriate for all public health positions in a response. 

E.5 Worker Protection and Employment–Public health recommendations were not 

universally supported by employee sick leave/employee absentee policies in business and 

industry. Workers feared losing their wages or jobs. 

E.6 Workforce Mandates–Ongoing questions and concerns about mandating vaccination for 

health care and other workers continue to affect pandemic response preparedness. 

Selected Successes/Mitigations Identified 

Flexing Existing Staff 

 “The existing health agency staff was flexible, well organized, dedicated and efficient during the 

event.” 

 “In addition to performing routine tasks, medical and public health staff carried additional duties.” 

 “To address laboratory staff capacity issues, additional cross-trained staff were utilized to process the 

H1N1 specimens and perform administrative duties; at times, staff were obtained from temporary 

workforce agencies and local health departments.”

Public Health Surge Capacity 

 “PHER funding allowed an increase in the local health department’s surge capacity by allowing and 

facilitating the hiring of temporary employees during the event.” 

 “Insufficient staff was available for vaccination during the event and retired public health veterans at 

the local health department level offered expert assistance during the surge.” 
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Association of State and Territorial Health Officials Page 119 

 “State public health laboratory work spaces, changes in work schedules and functional teams 

facilitated capability to meet an increased demand for testing, mailing of kits, and test result 

reporting.” 

 “Many public health agencies across the state conducted response efforts with minimal personnel and 

shortages of credentialed staff.” 

 PHER grants provided vital funding to supplement public health workforce capacity, particularly in 

key areas such as surveillance and immunization. States used PHER funds to hire additional, but 

temporary, staff. 

 Some states reported “paying overtime as an incentive for staff to work longer hours, and hire, when 

available, private contractors.” 

 One state reported “establishing a pool of staff that were trained to ‘adequate’ levels within each of 

the ICS needed. The agency attempted to rotate people in/out on a 7-day cycle, although it took 

several weeks to refine this process.” 

 Other states created “strike teams composed of seasoned public health workers/champions functioned 

as trainers and organizers for community and school-located vaccination clinics.” 

 “State and local health drew heavily on volunteer resources to extend departmental capacity. This was 

effective for the short-term, but would not have been sufficient for a more severe H1N1 outbreak.” 

Health Care/General Surge Capacity 

 “When accessible, the use of school nursing staff, translators for non-English speaking patients and 

existing contracts and services with private vendors (i.e. trucking companies for distribution), as well 

as the individual training and agency cross-training conducted prior to the event proved advantageous 

during the incident in achieving a high level of collective preparedness.” 

 One state noted using “a significant portion of the PHER funds to contract with private health care 

providers to assist with the statewide vaccination campaign.” 

Volunteers 

 “Response efforts from volunteer nurses at the local level and, at the state level, from state 

universities, were a large part of existing, collaborative partnership efforts.” 

 “In general, the use of volunteers at the local level was effective; however, state and local public 

health found that they could not use volunteer staff as effectively for fulfilling key public health roles. 

Individuals with an intricate knowledge of the state’s public health system should have filled these 

roles internally.” 

 “The state used volunteers to deal with staffing shortages; they saved counties tens of thousands of 

dollars, and remained committed and engaged in PODs throughout the vaccination campaign.” 

Employment Issues 

 “The health agency was not able to directly affect labor laws relating to wages and benefits, therefore, 

it addressed the issue indirectly by stressing basic infection control practices. Information about hand 

hygiene and respiratory etiquette were widely available and free seasonal and H1N1 vaccines were 

eventually offered to the public.” 
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Association of State and Territorial Health Officials Page 120 

Barriers/Recommendations Identified Detail 

Public Health Workforce Surge Capacity 

Issue: E.1 Flexing and surging the public health workforce was a challenge, 

especially as repeated rounds of budget cuts and hiring freezes 

have shrunk standing capacity in state health agencies. 

Issue Type: Policy; Legal 

Level: State 

Discussion: Existing Capacity Strained 

Flexing the existing public health workforce was a challenge, especially as 

“repeated rounds of budget cuts and hiring freezes have shrunk standing 

capacity in state health agencies.” In some states, a “lack of depth in key 

positions due to retirements and unfilled position vacancies hindered 

response activities.” One person commented that “the inadequate and thin 

public health workforce resulted in key staff working 16 hour days, with all 

program staff participating in just the H1N1 response activities.” 

EOC/ICS Capacity 

Some states reported “insufficient state staff capacity to sustain activation of 

emergency operations centers (EOCs) for long periods of time.” States 

acknowledged that “many staff had to be pulled in from other public health 

agency programs beyond preparedness to staff the EOC.” As a result, “many 

public health programs were forced to put their regular activities and 

responsibilities on hold, or on reduced staffing levels, which put them 

further behind.” 

Supplementing Capacity 

PHER funds helped tremendously in staffing needs “but the overall public 

health force was substantially small at the beginning of the H1N1 outbreak.” 

Even with PHER funds, states noted that “because of states’ fiscal crises, 

there was reluctance on the part of state personnel agencies to hire staff, 

even for a limited term.” One person commented that “temporary employees 

required intensive training by staff already taxed with response activities.” 

One state noted a distinction in its laws between “state health agency staff 

who were detailed to assist at vaccination clinics versus those who 

volunteered their time to assist.” Staff who volunteered were treated as 

private citizens and were not required to be compensated as per the 

volunteer agreement they signed. The state noted that “assigning staff to 

details in support of the mass vaccination clinics caused discontent among 

the workforce and created labor union issues with compensation for the time 

and attendance.” 
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Association of State and Territorial Health Officials Page 121 

H1N1 Surge Impacted Agency Programs and Staff 

A respondent observed that “state agency staff in areas such as 

immunization, preparedness, epidemiology, and laboratories was generally 

unable to address any program elements other than H1N1 response for 

several months.” One state’s immunization program revealed the 

“significant programmatic and staff impacts caused by the H1N1 response: 

Staff was overtaxed and its requests for help were not acknowledged within 

the agency until the situation had progressed to an unacceptable level. The 

lack of responsiveness to many requests for help took an emotional and 

physical toll on many immunization staff members.” It was felt that “the 

health agency upper management’s failure to act upon or recognize program 

staff’s need for assistance has led to long-term consequences ranging from 

staff illness to lack of trust.” 

Tracking and Compensating Surge Activities 

One state noted that “staff with critical skills was not identified prior to the 

event and it was difficult to make these decisions in the middle of a 

response.” Restrictions on H1N1 funds resulted in “difficulty flexing staff to 

fill needs directly or backfill for staff diverted to the response.” The state 

also noted that: “The extended and intense response by staff members left 

many exhausted as dedicated staff was not prepared for the change in work 

schedule. With individual exceptions, epidemiology and immunization staff 

carried the brunt of the workload for an entire year.” It was concluded that 

“human resource policies need to be further developed and improved in 

order to track and compensate for time spent on response.” 

Lack of Sustained Public Health Workforce and Infrastructure Support 

States uniformly acknowledged that the “lack of sustained, ongoing funding 

to support public health infrastructure resulted in limited capacity to respond 

without supplemental funding.” It was observed that “short-term, 

supplemental dollars are not an adequate alternative to thoughtful, consistent 

funding geared to building core capacity, ensuring the availability of a 

trained workforce and adequate laboratory and health system surge 

capacity.” As a result of shrinking federal and state dollars, “state and local 

health departments have cut back on core public health components, leaving 

them without the staff and resources required to mount a quick and 

coordinated response to an event such as H1N1.” 

One respondent acknowledged that: “Communities without a full-time 

health director lacked the capacity to organize and conduct mass vaccination 

campaigns. While PHER dollars helped to address gaps, the restrictions on 

the use of funds hampered efforts to meet local needs.” 

Mitigation 

Strategies 

Employed: 

Supplementing Capacity 

 PHER grants provided vital funding to supplement public health 

workforce capacity, particularly in key areas such as surveillance and 

immunization. States used PHER funds to hire additional, but 

temporary, staff. 
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Association of State and Territorial Health Officials Page 122 

 Some states reported “paying overtime as an incentive for staff to work 

longer hours, and hire, when available, private contractors.” 

 One state reported “establishing a pool of staff that were trained to 

‘adequate’ levels within each of the ICS needed. The agency attempted 

to rotate people in/out on a 7-day cycle, although it took several weeks 

to refine this process.” 

 Other states created “strike teams composed of seasoned public health 

workers/champions functioned as trainers and organizers for community 

and school-located vaccination clinics.” 

 “State and local health drew heavily on volunteer resources to extend 

departmental capacity. This was effective for the short-term, but would 

not have been sufficient for a more severe H1N1 outbreak.” 

Recommendations 

Suggested: 

Supplementing Capacity 

 “More highly trained staff (epidemiologists, laboratory technicians, and 

budget staff) is required during surges for a sustained period; surge 

capacity cannot be addressed with just in time training.” 

 “CDC needs to be very explicit in their grant guidances concerning the 

expeditious hiring of personnel so the overall intent of grants can be 

realized in a timely manner.” 

 “Develop training programs to allow the use of non-health personnel to 

vaccinate or dispense medications during an emergency response.” 

 “Develop future agreements with medical schools to provide public 

health surge capacity.” 

 “Training additional nurses who are prepared for public health roles, 

training local health departments to outsource flu clinics at nontraditional sites, schools and including more basic staff to keep programs 

running are strongly recommended.” 

 “Rebuild the public health infrastructure during non-emergency times, 

so that there is adequate staffing to rely on in during a pandemic or other 

emergency event.” 

Tracking and Compensating Surge Activities 

 “Participants proposed that policies be developed to provide clear 

direction on flexing hours, overtime and shift flexibility (how long staff 

are eligible to work), compensation, and sick-leave for all employees.” 

 “State and local governments should further develop Human Resource 

policies regarding compensation, tracking personnel time and workplace 

needs for state/local employees.” 
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Association of State and Territorial Health Officials Page 123 

 “Participants also identified that local government should consider 

allowing non-health department staff to receive compensation for extra 

hours worked for future incidents.” 

 “State should further develop standards for human resource polices that 

can be used by local agencies in the development of their policies.” 

Funding Public Health Surge Capacity 

 “Ensure that public health preparedness is recognized as a key 

component of the nation’s homeland security strategy, and is treated on 

a par with federal and state funding for other national security response.” 

 “More staff will need to be identified for various EOC/ICS positions, 

routinely trained, and provided opportunity to remain engaged. This will 

require more funding beyond what can presently be accomplished with 

base funding.” 

 “Some of the PHER money should have been kept at the state level to 

use to hire additional help, rather than sending the majority to local 

health department.” 

 “Sustained investments by local, state and federal government to fund 

public health infrastructure and surge capacity across county lines to 

meet vaccination program needs, as well as for SNS receiving and 

distribution is recommended.” 

 “Increase funding levels and resources for public health infrastructure to 

sustain required services.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Health Care/Medical Surge 

Issue: E.2 Surge capacity among in the health care sector is limited and could 

be quickly overwhelmed during a prolonged pandemic event. 

Issue Type: Policy; Legal 

Level: State 

Discussion: Health Care Surge Capacity 

Health care medical surge capacity is limited in many jurisdictions. This 

presents a challenge in mounting a community-wide response. Many states 

fear that “had the H1N1 outbreak been worse, public health agencies and 

health care organizations would have been severely taxed.” 
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Association of State and Territorial Health Officials Page 124 

In states with minimal local public health infrastructure, it was seen as a 

“challenge to enlist enough medical personnel to conduct a sustained, 

statewide vaccination effort.” Other states reported that: “Fortunately, the 

private health care sector was able to significantly supplement public 

health’s efforts through contracts using PHER funds. Without supplemental 

federal funding, the situation would have been drastically different.” 

At many hospitals, the “worried well” overwhelmed emergency 

departments. One state health agency official commented that “H1N1 has 

changed the thought behind what a hospital needs so H1N1 policy may help 

drive decisions on hospital flow and the way people are moved through the 

hospital.” 

Community Health Centers 

A state noted that: “Community health centers (CHC) cannot legally work 

outside their scope of practice (assigned zip codes and populations) due to 

legal and insurance constraints. They are limited in their ability to offer 

support to hospitals and clinics experiencing patient surge.” 

Mitigation 

Strategies 

Employed: 

 One state noted using “a significant portion of the PHER funds to 

contract with private health care providers to assist with the statewide 

vaccination campaign.” 

Recommendations 

Suggested: 

Health Care Surge Capacity 

 “The Institute of Medicine has documented that emergency departments 

are in trouble. There is a need for sustained funding for hospital 

preparedness and trauma centers.” 

 “Increased and consistent federal funding to the states to augment public 

health infrastructure is necessary.” 

Community Health Centers 

 “Legal and policy restrictions regarding CHCs need to be changed to 

allow for a more coordinated response and increasing community surge 

capacity.”

[Sources: Survey: X Meetings: X Environmental Scan: X ] 
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Association of State and Territorial Health Officials Page 125 

Volunteer Surge Capacity 

Issue: E.3 Volunteers participating in the H1N1 response expressed fears 

about their potential legal liabilities during the response. 

E.4..Volunteers provided important surge capacity to the H1N1 

response, but they are not appropriate for all public health 

positions in a response.

Issue Type: Legal 

Level: State; Federal 

Discussion: Volunteer Liability Concerns 

See related discussion and recommendations in Section III.A above 

regarding liability concerns.

Role of Volunteers in Response 

One state acknowledged that maintaining public health and hospital staffing 

during the peak of the H1N1 outbreak was a challenge. It noted that “using 

volunteers at the local level was generally effective; however, state and local 

public health found that they could not use volunteer staff as effectively for 

fulfilling key public health roles.” The state believed that “individuals with 

an intricate knowledge of the state’s public health system should have filled 

these roles internally.” 

It was also commented that: “Surge capacity for hospitals continues to be an 

issue, as hospitals do not want to divert their staff to off-site facilities. 

Staffing continues to be the biggest barrier to alternate care facility planning. 

The solution may be to surge as much as possible in the hospital where staff 

capacity already exists in addition to using retired medical personnel and 

students.” 

Mitigation 

Strategies 

Employed: 

Volunteer Liability Concerns 

See related discussion and recommendations in Section III.A above 

regarding liability concerns.

Recommendations 

Suggested: 

Volunteer Liability Concerns 

See related discussion and recommendations in Section III.A above 

regarding liability concerns.

Role of Volunteers in Response 

 “The use of volunteers needs to be restricted to non-critical public health 

roles.” 
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Association of State and Territorial Health Officials Page 126 

 “Need to re-evaluate roles for volunteers and contractors during an 

emergency event, clearly defining those roles for public health staff vs. 

volunteers and ensuring the proper staffing is available for emergency 

response needs.” 

 “Local health care coalitions need to look at using retired medical 

personnel as well as medical and nursing students for surge staffing.” 

 “Conduct federal background checks for all ESAR-VHP volunteers. This 

should be done by HHS; states cannot afford to conduct these 

background checks using current funds.” 

 “Engage volunteers in additional preparedness training and exercises.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Worker Protection and Employment 

Issue: E.5 Public health recommendations were not universally supported by 

employee sick leave/employee absentee policies in business and 

industry. Workers feared loosing their wages or jobs. 

Issue Type: Legal; Policy 

Level: State; Federal 

Discussion: Concerns about Sick Leave; Loss of Wages, Jobs 

States expressed concern about “workers who do not have paid sick leave or 

who may have sick leave but were required to produce a medical note 

following an illness-related work absence.” A respondent noted that: 

“Working people in the affected groups would not easily be able to remain 

home from work while ill or avoid a visit to a healthcare provider (thus 

burdening the medical sector and potentially exposing the worker to H1N1). 

Workers exempt from federal overtime and minimum wage standards, such 

as home care workers, are also unlikely to receive paid sick leave. These 

workers would likely continue to work while ill to preserve their wages and 

jobs, and would not be able to comply with public health recommendations. 

The health agency was not able to devise direct remedies to address this 

barrier. Neither federal labor law nor private and public sector workplace 

rules were within the control of the agency.” 

Other states noted that: “Workers with sick leave had questions about 

whether their employers’ sick leave policies would cover persons who have 

been exposed to or are quarantined for a communicable disease. People in 

quarantine are not yet sick but must be absent from the workplace. They 

may not be eligible for sick leave status under their employers’ sick leave 

policies.” 
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Association of State and Territorial Health Officials Page 127 

Employer Privacy/Disclosure Obligations 

States expressed uncertainty as to: “Whether an employer is obligated to or 

may otherwise divulge the nature of an employee’s illness (e.g., H1N1 

influenza). Employers are faced with the dilemma of protecting a sick 

worker’s privacy but also may want/need to advise other employees about 

their possible exposure to illness. Employers also have concerns about 

potential liability arising from their failure to inform well employees of 

potential risks from sick co-workers. The answers to these issues may differ 

with the field or industry in which the employer operates (e.g., healthcare 

and non-healthcare employers and between public and private employers). 

One state’s law authorizes the employer to inquire about workers’ health 

status, but require hospitals to exclude ill healthcare workers.” 

Mitigation 

Strategies 

Employed: 

Concerns about Sick Leave; Loss of Wages, Jobs 

 “The health agency was not able to directly affect labor laws relating to 

wages and benefits, therefore, it addressed the issue indirectly by 

stressing basic infection control practices. Information about hand 

hygiene and respiratory etiquette were widely available and free 

seasonal and H1N1 vaccines were eventually offered to the public.” 

 “Six states have existing statutory protections for employees by 

prohibiting the termination of an employee subject to isolation or 

quarantine. Another state requires that an affected employee must be 

reinstated following quarantine or isolation. Another state requires an 

employer to grant either paid or unpaid leave to an employee who is 

subject to quarantine or isolation.” 

Recommendations 

Suggested: 

Concerns about Sick Leave; Loss of Wages, Jobs 

 “Clear guidance is needed on the intersection of employee legal 

protections and employer actions. This includes workplace policies on 

leave usage (e.g. sick time, vacation, etc.), loss of income due to leave 

taken, workplace restrictions (e.g. when to send staff home when sick, 

how to monitor staff for illness), and workplace provisions regarding 

vaccinations, antivirals, and personal protective equipment (PPE). Each 

state and local government addressed these independently, resulting in 

lack of coordination.” 

 “Consider federal reimbursement for lost wages as Toronto did 

following the SARS outbreak.” 

 “Changes in federal labor laws that require employers of domestic 

workers to provide benefits that are in line with those provided to other 

classes of worker.” 

 “Consider seeking revisions to federal and state unemployment 

compensation law, such as authorizing payment of unemployment 

compensation during a declared public health emergency so that workers 
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Association of State and Territorial Health Officials Page 128 

will be more likely to remain home and reduce the risk of transmission 

of the disease.” 

 “Review other potentially relevant laws, such as the Family Medical 

Leave Act, for possible revisions that would encourage employees to 

comply with isolation, quarantine or social distancing measures.” 

 “Review options for issuance of guidance for employers regarding 

quarantine and sick leave policies as well as other options that may be 

available (such as administrative leave) to reduce the potential spread of 

the disease through the worksite.” 

 “Federal, state and local governments as well as the business community 

should develop flexible leave policies which include the ability to 

suspend the requirement for a doctor’s note during a public health 

emergency that has the capacity to severely overburden the healthcare 

system.” 

 “Employers should not require medical verification for H1N1 absence.” 

 “Work with private organizations to change corporate culture; 

employees should be encouraged to stay home when they are sick and 

HR policies should not require documentation from a physician 

confirming H1N1 or other widespread illnesses.” 

 “Provide federal support for low-income families to stay home when 

kids are sick.” 

 “State and local governments should continue to communicate with the 

business community and share public health guidance and 

recommendations.” 

 “Department of Education, in partnership with state and local public 

health, should work more closely with the private sector to provide 

information on school closures and other school issues that potentially 

impact parents/private sector employees.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Issue: E.6 Ongoing questions and concerns about mandating vaccination for 

health care and other workers continue to affect pandemic 

response preparedness.

Issue Type: Policy; Legal 

Level: State; Federal 
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Association of State and Territorial Health Officials Page 129 

Discussion: Workforce Vaccination Mandates 

One state related that: “Many health care workers expressed concern that 

there were limited numbers of personnel in their facilities that chose to be 

vaccinated against H1N1. Hospital partners questioned whether mandating 

vaccination in this situation [H1N1] would work, as other vaccines (MMR) 

are mandated in order to work in a healthcare setting.” 

A state noted that “mandatory vaccination policies in selected workplaces 

resulted in significant challenges.” The “lack of vaccination policy for 

laboratory workers and state employee vaccination opportunities were not 

addressed until late in the vaccination campaign.” It was observed that with 

“early employee vaccination, the state would have led by example.” 

FluMist Concerns 

One state reported that: “FluMist was the first vaccine presentation available 

for health care workers. In the past, health care workers were told that if they 

were vaccinated with FluMist, they could possibly transmit live virus to 

patients; thus many healthcare workers were not willing to be vaccinated 

with FluMist during H1N1. Many hospitals sent the FluMist presentation 

back without vaccinating their healthcare workers.” 

Mitigation 

Strategies 

Employed: 

None identified 

Recommendations 

Suggested: 

Workforce Vaccination Mandates 

 “Directives to vaccinate healthcare workers should come out from the 

federal level and not from the state, local or facility level.”

 “During future pandemics, the federal government should mandate that 

influenza vaccination be required of all healthcare practitioners.” 

 “Develop policies on mandatory workforce vaccinations for various 

categories of workers.” 

FluMist Concerns 

 “CDC needed to provide more specific information on FluMist and other 

intranasal presentations for healthcare workers.” 



[Sources: Survey: Meetings: X Environmental Scan: X ] 

 
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Association of State and Territorial Health Officials Page 130 

III.F Federal/State/Local Coordination 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified

The primary barriers identified related to federal, state and local coordination issues were (numbering 

does not reflect a priority order for the barriers): 

F.1 Intergovernmental Coordination–Coordination between and among federal, state, and 

local governmental entities was inconsistent over the course of the H1N1 response. 

F.2 Federal Grants and Cooperative Agreements–PHER grants provided states with the 

resources necessary to mount H1N1 response activities, but requirements for managing 

the grants were cumbersome and time-consuming. 

F.3 Federal Grants and Cooperative Agreements–Federal grant and cooperative 

agreement requirements generally did not allow the states’ enough flexibility to surge 

personnel and resources in mounting H1N1 response activities.

F.4 State Systems/Operations–Some state governmental policies and procedures, as well as 

the internal operations of state agencies, tended to delay the rapid deployment of funds 

and personnel designated for pandemic response activities. 

F.5 Pandemic Influenza Planning–Pandemic influenza planning has been geared toward a 

worst-case scenario but must become more flexible and scalable to allow for pandemics 

of less virulent influenza viruses. 

Selected Successes/Mitigations Identified 

Intergovernmental Coordination 

 “Overall, interagency collaboration was successful at all levels.” 

 “Constant internal communication channels of federal, state and local agencies seemed to improve the 

efficiency and effectiveness of the H1N1 response.” 

 “Federal, state, and local partners swiftly coordinated H1N1 response efforts.” 

 “Although setbacks at all levels of government occurred, public health agencies diligently succeeded 

with administering H1N1 vaccine to the public.” 

Coordination of Federal and State/Local 

 “States supported ASTHO’s efforts to work with HHS to develop a workable concept of operations 

and more clearly identify protocols for gathering and sharing situational awareness information.” 

 “To address the perceived lack of a national common operating picture, state emergency operation 

centers tried to pull information from a variety of sources, but left untapped data in other federal, 

state, and local emergency operation centers.” 
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Association of State and Territorial Health Officials Page 131 

Coordination of States and Locals 

 “In home rule states, state health agency staff attempted to gather input from local health departments 

before making decisions in order to achieve some uniformity at the state level. The state also worked 

individually with those localities that did not follow state policy.” 

 “State legal counsel addressed local health agencies’ concerns about liability risks during weekly 

health agency H1N1 conference calls.” 

Common Operating Picture 

 “Webinars, websites and weekly telecasts using the state’s telecommunications agency assured 

common operating goals.” 

 “To mitigate conflicting information from various federal and state agencies, the state utilized a crossagency unified command structure to determine all policy issues.” 

PHER Grant and Federal Funding Generally 

 “Under the Public Health and Social Services Emergency Fund, Congress allocated response funding 

to prepare for and respond to the novel influenza A (H1N1) virus.” 

 “As the lead federal coordinating agency for H1N1 response, the U.S. Department of Health Services 

(HHS) provided funding resources to states.” 

 “Access to funding permitted the utilization of additional staff in assisting with the vaccination 

efforts.” 

 “PHER funding also supported temporary laboratory personnel.” 

 “The infusion of federal funding was extremely helpful.” 

 “The total federal funding amount distributed to the state was sufficient.” 

 “Funding obtained through the PHER grant was used to quickly hire additional regional health 

department staff to assist with response efforts.” 

 “Public health officials agreed previous funding resulting from avian influenza established a 

foundation for a national response, requiring states and local governments to identify pandemic 

planning as a priority.” 

 “Hiring additional fiscal and grant management staff helped with some of the fiscal and grant 

management issues; however, program staff were diverted from program work to develop/amend 

multiple contracts for the various phases of PHER funding and were required to work extensive hours 

to accomplish both grant management and program response requirements.” 

 “Streamlined local application processes and issued advance payments to allow work to begin 

expeditiously. This helped some local health departments but others were unable to take advantage of 

the advanced payments due to local governing body (e.g., town council, board of supervisors) 

requirements for approved budgets and work plans before any funds could be expended.” 

State Systems/Operations 

 “The state found it more expedient to hire temporary, yet less skilled, workers to meet immediate 

response needs rather than attempt full-time hires.” 

 “To mitigate the effects of being unable to immediately access PHER funds because of state budget 

and procurement processes, the health agency used other existing funding streams for procurement 

actions until the H1N1 supplemental funding was available. Once the PHER funds were available, 

H1N1 expenses were re-journaled to PHER funds; however, this practice restricted use of the original 

funding streams until the re-journaling could occur. This delayed implementation of normal 

programmatic activities until late in the grant year.” 
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Association of State and Territorial Health Officials Page 132 

 “Health agency program staff tried to educate fiscal staff within the health agency and in the state’s 

department of administration about the necessity to process H1N1-realted requests quickly.” 

 “The federal government needs to recognize that state requirements can impose obstacles to speedy 

implementation of federal goals. Frequently, the principal remedy was issuance of executive orders 

under the emergency powers of the Governor to suspend procedural requirements for H1N1 activities. 

However, such executive orders can be difficult to obtain.” 

Coordination with Stakeholders 

 “Public health and health care sector interaction, as well as health department interaction with local 

health care providers, hospitals, and EMS collaboration were rated “extraordinary”.” 

 “The state medical/ethical societies and the state judiciary committee, along with key stakeholders, 

convened a task force for the utilization of scarce critical care resources during the pandemic which 

proved advantageous.” 

 “Within the state’s laboratory forum, stakeholder engagement and lab response to members’ 

questions provided valuable feedback via impromptu conference calls, as well as the FAQ’s that were 

published.” 

 “The state has established strong working relationships with tribal nations, state and local agencies, 

and healthcare providers.” 

Technical Assistance 

 “Communication vehicles, such as regular conference calls with federal officials (the Department of 

Homeland Security [DHS], Federal Emergency Management Agency [FEMA], CDC, etc.) for PIO’s 

as well as technical assistance calls from the Association for Public Health Laboratories (APHL), 

proved critical for specific technical issues.” 

Pandemic Planning 

 “The state recognizes the federal government for establishing a priority for pandemic readiness and 

planning.” 

 States adjusted their strategies based on the less severe circumstances posed by H1N1. States revised 

their strategies for community mitigation and recommendations related to school attendance/closures. 

Barriers/Recommendations Identified Detail 

Intergovernmental Coordination 

Issue: F.1 Coordination between and among federal, state, and local 

governmental entities was inconsistent over the course of the H1N1 

response. 

Issue Type: Policy; Legal 

Level: Federal; State 

Discussion: Coordination of Federal and State/Local 

States found that coordination between federal and state/local agencies was 

inconsistent. Some linked poor coordination with the lack of a clear Incident 
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Association of State and Territorial Health Officials Page 133 

Command Structure (ICS) through which to work on a combined federal and 

state response. The perception was that “Homeland Security, CDC, and FDA 

had different messages to some of the same audiences, frequent 

uncoordinated requests of states, and different information-sharing 

distribution lists and protocols.” Consequently, the “lack of a coordinated 

front on the federal level made it more difficult to have a coordinated front 

at the state level.” Different state agencies responded to the requests/needs 

of different federal agencies, “often without knowing what the others were 

doing.” One state noted that “tracking so much confusing information from 

so many sources impeded prudent decision making and even caused 

response partners to work at cross purposes.” (See also Section III.A above, 

“ICS, Command and Control, and Authority.”) 

While states did acknowledge frustrations with the lack of coordination 

among federal agencies, states also gratefully acknowledged CDC’s efforts 

to coordinate the public health response, and affirmed the value of CDC’s 

frequent conference calls to share timely information and clarify key 

information. Also noted was the value of on-the-ground technical assistance 

provided by federal employees. 

 Concept of Operations/Common Operations Platform: Some found that: 

“There was a lack of a clearly defined federal concept of operations that 

specified federal and state responsibilities and mechanisms for 

coordination. CDC, HHS, state and local emergency operations centers 

did not obtain information from each other to build a common operating 

picture. Information for situational awareness was derived from other 

sources in a work-around fashion.” 

 Understanding Differences in State Approaches: Some states expressed 

the view that: “At times, federal personnel/agencies lacked a basic 

understanding of and appreciation for states’ different policy/legal 

approaches and requirements in their emergency response activities.” A 

lack of federal understanding about state legal schemes regarding health 

care professionals licensing, emergency management acts, and 

pharmaceutical regulations were given as examples. According to some 

states, “many fundamental questions were repeatedly asked by many 

people many times.” 

Differences in state statutory requirements made it more difficult for 

some states compared to others in providing information or approaching 

issues uniformly across the states. For example, opt-in requirements that 

require a person’s consent before they are included in state 

immunization registry imposed a considerable burden on state staff that 

needed to use registries to track H1N1 vaccination coverage. States 

using opt-out or mandatory inclusion principles for their immunization 

registries could more readily track H1N1 vaccinations using this 

mechanism. 
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Association of State and Territorial Health Officials Page 134 

 Coordination of state and federal legal counsel across federal agencies:

State legal counsel have expressed the need to “expand relationships 

among legal counsel in federal agencies.” It was noted that: “State health 

agencies frequently work with counsel in CDC, but state and local 

public health agencies sometimes pose legal questions that fall under the 

domain of HHS agencies other than CDC, such as FDA and CMS, or 

under the domain of agencies in other departments, such as DHS/FEMA. 

They need ways to communicate effectively with such agencies during 

public health emergencies.” 

Coordination Among States 

Better systems should be developed for real-time sharing of approaches and 

innovations across different states, communities, and jurisdictions. In 

addition, neighboring communities should share and coordinate to the extent 

possible plans for providing care and information, and if necessary, 

resources. 

Coordination Within States 

The need for improved coordination among and within state agencies was 

also identified. More “frequent and proactive coordination among legal and 

programmatic staff during a response was identified as a priority by legal 

counsel.” This was especially noted “when decisions are being made as to 

whether to address a problem with a legal and/or a policy solution.” The 

need for better intrastate coordination also arose in the context of expediting 

state procurement and hiring practices during the H1N1 response. (See 

“Grants” discussion below in this section.) 

Coordination of States and Locals 

State and local coordination issues were also identified as a significant facet 

of the H1N1 response. 

 Managing communications with locals: States with larger numbers of 

local health districts needed to use multiple and frequent communication 

mechanisms to coordinate with local responders. It was reported that 

“local home rule policies in some states resulted in many jurisdictions 

making decisions that differed from statewide guidance and the actions 

of neighboring jurisdictions, requiring considerable coordination and 

communication activities by the state health agency.” 

 Continuing local liability concerns: Ongoing liability concerns of local 

health departments and volunteers required repeated intervention by 

state agency counsel. A respondent noted that “despite robust liability 

protections in the law, local health departments, and the providers and 

volunteers working with them, were not fully informed about the 

protections and therefore very concerned that their response activities 

would expose them to liability risk.” In one community, a “large 

provider demanded that a local county issue an emergency declaration as 

added protection, even though state health agency counsel informed the 

parties it was unnecessary.” 
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Association of State and Territorial Health Officials Page 135 

 Coordinating with local health agency counsel: Better coordination and 

communication with legal counsel to local public health agencies is 

needed. State and local public health counsel noted that: 

“Communication channels with legal counsel at the local level are not as 

well developed as they should be. Some local level legal counsel are 

faced with unique challenges, such as not being focused/specialized in 

public health law, being on retainer and only contacted as needed over 

more frequent involvement, frequent turnover, and not receiving as 

much communication from state or federal public health agencies or 

counsel.” 

Coordination with National Public Health Partner Organizations 

HHS, CDC and the states recognized the role of the national public health 

partner organizations during emergency response activities. States 

acknowledged that: “A regularly scheduled check-in among ASTHO, its 

affiliates, and partner organizations to share information among the states 

during the response would further improve the response. Information should 

also be shared among the national public health partner associations on a 

regular basis. Coordination efforts should also include the staff at national 

public health partner organizations. National organizations must work 

together to provide federal partners with state and local situational 

awareness, including communicating needs and identifying areas of 

collaboration and guidance prior to an event.” 

Mitigation 

Strategies 

Employed: 

Coordination of Federal and State/Local 

“States supported ASTHO’s efforts to work with HHS to develop a 

workable concept of operations and more clearly identify protocols for 

gathering and sharing situational awareness information.” 

“To address the perceived lack of a national common operating picture, state 

emergency operation centers tried to pull information from a variety of 

sources, but left untapped data in other federal, state, and local emergency 

operation centers.” 

Coordination within States 

“State agency legal counsels were not automatically included in H1N1 afteraction reviews due to simple oversight by program staff. Once the oversight 

was identified, program staff gladly included state counsel. Since the legal 

team may not be as visible during a response, they may not be immediately 

thought of as part of the response team.”

Coordination of States and Locals 

“In home rule states, state health agency staff attempted to gather input from 

local health departments before making decisions in order to achieve some 

uniformity at the state level. The state also worked individually with those 

localities that did not follow state policy.” 
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Association of State and Territorial Health Officials Page 136 

“State legal counsel addressed local health agencies’ concerns about liability 

risks during weekly health agency H1N1 conference calls.” 

Recommendations 

Suggested: 

Coordination at the Federal Level 

 “Ensure federal agencies adhere to national incident management 

standards and collectively make appropriate policy decisions when 

guidance crosses into more than one federal agency.” 

Coordination of Federal and State/Local 

 “Information flow could be improved through more streamlined 

messaging and greater predictability in the release of information.” 

 “Create a “common operating picture” as a means to more effectively 

share standardized data and information between the different levels of 

government.” 

 “Convene a federal/state/local working group to develop a concept of 

operations document that is vetted by stakeholders.” 

 “Build a set of data elements that develops a common operating picture 

for local, state and federal public health and medical operation centers 

and move the information up and down the chain.” 

 “Improve information flow between federal and state/local public health 

attorneys.” 

 “CDC’s Public Health Law Program and the Office of General Counsel 

should establish permanent mechanisms for state and local public health 

counsel to communicate rapidly with counsel across a range of federal 

agencies.” 

Coordination with States 

 “State health agency attorneys need to be better connected within their 

agencies in both planning and implementation so that the attorneys are 

aware as issues/problems develop and how they will be resolved. This 

would save counsel time in exploring a legal solution when the agency 

has decided on a policy fix.” 

 “Better coordination is needed between state public health and homeland 

security/emergency management.” 

Coordination of States and Locals 

 “During a response, state health agencies should continuously gather 

input from local health departments and work towards decisions that will 

allow for some consistency and uniformity when appropriate, while still 

respecting local autonomy.” 

 “Need to better reach and educate local health departments’ and health 

care providers' legal counsel so they can assure their clients of the 
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Association of State and Territorial Health Officials Page 137 

existing liability protections in place.” 

 “The CDC Public Health Law Program should consider developing 

additional ways to facilitate communication among legal counsel to 

local public health agencies.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Federal Grants and Cooperative Agreements 

Issue: F.2 PHER grants provided states with the resources necessary to 

mount H1N1 response activities, but requirements for managing 

the grants were cumbersome and time-consuming. 

F.3 Federal grant and cooperative agreement requirements generally 

did not allow the states’ enough flexibility to surge personnel and 

resources in mounting H1N1 response activities. 

Issue Type: Policy 

Level: Federal; State 

Discussion: PHER Grants 

States indicated that federal Public Health Emergency Response (PHER) 

grant funds were appreciated by state and local health departments and made 

many of their response activities more robust. However, PHER grant 

concerns were the most frequently identified barrier related to 

intergovernmental coordination issues. Overall, states found the PHER grant 

processes to be “inflexible and cumbersome, consuming considerable staff 

time that could have been better spent on H1N1 planning and response 

activities.” States identified a number of specific pre-award and post-award 

challenges associated with managing PHER grants. 

 Multiple funding periods and application processes: The complications 

of multiple PHER phases and “the unique requirements of each phase 

further exacerbated already difficult bureaucratic procedures including 

multiple local health department applications to the state for each phase, 

multiple requests for state expenditure authority during a difficult 

economic environment, and multiple contracts and purchase orders for 

each funding phase.” One respondent commented that “because the 

requirements for each phase were not known sufficiently in advance, 

each new phase of funding meant that state planning had to be revised 

numerous times.” 

 Allowable uses of funds ill-defined and changing: Changing restrictions 

and requirements on the use of PHER funds in each grant phase made it 

difficult for states to plan for funding streams over the life of the grant. 
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Association of State and Territorial Health Officials Page 138 

A number of states indicated they “found the grant guidance to be illdefined; some found that grant guidance only specified unallowable 

costs.” Concerning allowable costs, one respondent noted that “guidance 

from CDC seemed to put limitations on certain allowable costs relative 

to the stage of H1N1 response.” The uncertainty in allowable costs 

negatively affected how quickly and accurately states could respond to 

inquiries from local health departments and other sub-grantees. Another 

respondent reported that “local health departments had to wait for 

decisions concerning purchases pending CDC approval, which took 

weeks in some instances.” Other states reported that “some expenditures 

for purchases clearly allowed in the grant guidance were disapproved by 

federal PHER project officers.” 

 Slow approval of applications/spending requests: Use of a cooperative 

agreement format did not allow for an efficient approval process to 

respond to the emergent circumstances of H1N1. As a result, states 

found there were delays in PHER funding approval from CDC. 

Concerns were also voiced about CDC’s Procurement and Grants 

Office’s (PGO) inability to keep up with the volume of administrative 

responsibilities such as processing award notices, redirection requests, 

etc. 

 Unclear direction for carryover and redirection: There were conflicting 

interpretations of the PHER grant guidance regarding the duration of the 

grant as a one-year grant with a two-year carryover period. States 

planned their use of the grant with that understanding. States 

overwhelmingly expressed concern over CDC’s potential decision not to 

allow use of PHER funds past July 31, 2010. Because states had 

developed plans to use the funds over a longer period, the inability to 

use carryover funds would put these state plans, and therefore states’ 

preparedness in jeopardy. One respondent indicated that “states are 

unable to determine the appropriate responses for the remainder of this 

fiscal year and cannot conduct program planning for next year because 

of uncertainty over the PHER carryover funds.” 

 Problems with reporting requirements: States indentified unrealistic 

reporting requirements given the timing of the PHER grants. States 

indicated that “reporting requirements were changed mid-grant, resulting 

in situations in which states’ had not collected required data elements 

from the start of the response making reporting difficult.” 

 Too much emphasis on vaccine purchases to the detriment of other 

medical countermeasures and laboratory needs: A number of states had 

the perception that: “The PHER funding and tracking activities were 

primarily focused on vaccine and vaccine delivery. The multi-faceted 

response–antiviral distribution, community mitigation, infection control, 

and public aware activities– undertaken by states were not adequately 

recognized given the focus of grant tracking activities.” Other states 

expressed frustration that “so much of the PHER grant went to the 
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Association of State and Territorial Health Officials Page 139 

purchase of vaccines, the arrival of which were late and did not match 

with public demand; states are now faced with disposing of significant 

amounts of unused H1N1 vaccine supplies.” 

One state noted that PHER funds were not available for laboratory 

expenses after Phase 1. Since most of these funds went to cover spring 

2009 costs, the state was “unable to hire needed lab staff and was limited 

as to the types and amounts of supplies it could buy.” 

 Other PHER grant concerns: States also commented that “the timing of 

the funding awards did not match the states’ response needs.” Others 

noted that “the PERFORMS system was inefficient and required 

considerable staff time to use.” 

The combination of the above issues slowed the states’ ability to deploy the 

PHER funds for response efforts, delaying both state and local activities. 

Flexing Federal Grants/Cooperative Agreements Generally

States expressed the need for greater latitude in using federally-funded 

personnel and programs to surge the states’ response capacity during an 

emergency. As one state noted, “with limited numbers of individuals at the 

state level to serve in the ICS, it was difficult to assign individuals that are 

funded through other CDC programs to assist in the response when only 5% 

of their time could be utilized outside of their funded job duties.” 

Furthermore, “federal categorical funding does not provide authority for 

staff to respond to a disaster that was a national public health emergency; 

staff funded by grants from CMS, WIC and other federal sources were 

unavailable for response.” 

Mitigation 

Strategies 

Employed: 

PHER Grants 

States identified several mitigation strategies: 

 “Hiring additional fiscal and grant management staff helped with some 

of the fiscal and grant management issues; however, program staff were 

diverted from program work to develop/amend multiple contracts for the 

various phases of PHER funding and were required to work extensive 

hours to accomplish both grant management and program response 

requirements.” 

 “Streamlined local application processes and issued advance payments 

to allow work to begin expeditiously. This helped some local health 

departments but others were unable to take advantage of the advanced 

payments due to local governing body (e.g., town council, board of 

supervisors) requirements for approved budgets and work plans before 

any funds could be expended.” 

 “Funding was used to quickly hire additional staff for regional health 

agency offices to assist with response efforts.” 
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Association of State and Territorial Health Officials Page 140 

 “There was no “work-around” possible to some of the PHER grant 

barriers. The funding was integral to H1N1 response, so states had to 

spend the time on the application process as it was presented.” 

Recommendations 

Suggested: 

PHER Grants 

States identified a number of recommendations to address some of the 

specific PHER grant-related barriers identified: 

Multiple funding periods and application processes:

 “Funds should be awarded in one phase with more flexibility on their 

allowable uses in order to permit states’ to use funds to cover their 

unique response efforts.” 

 “Awarding the funds in one phase would streamline the purchasing and 

contracting processes at both the state and local levels.” 

 “Identify more appropriate mechanisms for funding response activities. 

The grant process is better designed for funding long-term enhancement 

activities, not emergency response operations.” 

 “Decrease the number of applications required to secure the same funds 

and reconsider using similar application processes that CDC used during 

the post 9/11 PHEP supplemental awards and pandemic influenza 

supplement in 2006. Specifically, use the methodology of releasing 20% 

of the funds, with authorization for use of the additional 80% based on a 

comprehensive application submission.” 

Allowable uses of funds ill-defined and changing: 

 “Clear and consistent direction should be provided as to the period of 

use of the funds including the ability to redirect and/or carryover funds.” 

 “Allow the purchases of services and supplies as provided by the 

guidance during the full life of the grant cycle.” 

 “Provide one guidance document at the outset for the entire funding 

stream.” 

Slow approval of applications/spending requests: 

 “Instead of following the usual steps for a grant application, exceptions 

should be made in order to free staff to work on planning and response 

activities when the country is in the midst of an emergency event.” 

 “CDC should work with states to formulate templates for ‘emergency’ 

funding applications that still have elements of accountability, but do not 

take weeks to complete and can be quickly approved by CDC/PGO.” 

 “Develop a system that provides a less restrictive process and that does 

not require the intervention and approval of project officers and PGO to 

approve budgets in the same way cooperative agreements are 
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Association of State and Territorial Health Officials Page 141 

implemented.” 

Unclear direction for carryover and redirection:

 “CDC and OMB need to agree that the original grant guidance for all 

PHER Phases allow for carryover.” 

 “Health departments are still in the process of responding to H1N1. 

Recovery efforts and improvement plans will be taking place long after 

July 31, 2010. This potential limitation on the use of PHER funds makes 

it very difficult to be good stewards of public funds.” 

Problems with reporting requirements:

 “CDC should simplify the PHER reporting requirements to reduce the 

burden on staff already engaged in response and normal duties.” 

Too much emphasis on vaccine purchases to the detriment of other medical 

countermeasures and laboratory needs: 

 “Although vaccination was a primary role for every state, laboratory 

testing and surveillance were critical to ongoing monitoring of H1N1 

and funds should have been made readily available for these purposes.” 

 “Either have the guidance address the scope of response and recovery or 

provide more flexibility for state and local prioritization.” 

PERFORMS system required considerable staff time to use: 

 “The PERFORMS system should be programmed to allow the 

application and requests for redirection and/or carryover to be completed 

within the system as other forms and documentation lead to confusion 

and extended the workload for both the states and CDC staff.” 

 “To avoid duplicative efforts for application submission through 

Grants.gov and PERFORMS, consider allowing a letter of intent 

submission by the state without full narrative or budget and budget 

justification through both systems. Since a letter of intent may not 

suffice for federal use of grants.gov, consideration could be made for 

submission first through PERFORMS, which would then provide output 

reports that could be uploaded into grants.gov following PERFORMS 

submission.” 

PHER Overall: 

 “Provide state and local public health with greater administrative 

flexibility for a fuller range of program activities and, in anticipation of 

future funding, be proactive in crafting simpler and more efficient 

administrative process to award funds and monitor and evaluate 

performance.” 

Flexing Federal Grants/Cooperative Agreements Generally

 “Federal grants and cooperative agreement requirements and processes 

need to be more flexible during public health emergencies. The federal 
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Association of State and Territorial Health Officials Page 142 

funding process should allow federal agencies to advance a portion of 

emergency grant funds to state/local governments so they can initiate 

response activities immediately. Having to await the full application and 

review process delays initial response activities.” 

 “CDC should allow for staff in positions that are funded by any CDC 

program to assist in a public health emergency response as long as they 

are needed.” 

 “Federal authority should be provided to programs to allow use of 

already funded staff on categorical sources to participate in a response 

where there is a Public Health Emergency Declaration or a Stafford Act 

declaration.” 

 “The federal government should lift restrictions on allowing states to 

reassign employees supported by federal funds so they could help with 

future emergency response efforts.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

State Systems/Operations 

Issue: F.4 Some state governmental policies and procedures, as well as the 

internal operations of state agencies, tended to delay the rapid 

deployment of funds and personnel designated for pandemic 

response activities. 

Issue Type: Policy; Legal 

Level: State 

Discussion: States frequently acknowledged that their “own state procurement and 

personnel systems hindered quick H1N1 response activities.” In some states, 

the lack of a state emergency declaration slowed state procurement and 

personnel requirements; in other states, the procurement/personnel processes 

were still slow despite state emergency declarations. 

In states that did not declare an emergency during the H1N1 outbreak, 

normal budgeting and procurement processes remained in place. One 

respondent noted that “the timing of receipt of PHER grant funds in August 

2009 did not allow some states to fully process the funds within their fiscal 

years ending September 30.” One state reported that, “since PHER funds 

were not forecasted by the health agency and were therefore unbudgeted, the 

agency had to first request authority to budget the funds and then budgets 

had to be loaded into the state’s procurement system before normal 

competitive contracting actions could begin.” 
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Association of State and Territorial Health Officials Page 143 

Even hiring temporary staff proved to be difficult in some states. One state 

that characterized itself as being in fiscal crisis noted that “the state’s 

department of administration was reluctant to hire staff, even for a limited 

term.” Overall, “delays in getting personnel in place to help with planning, 

call centers, and vaccine processing and tracking hindered the state’s H1N1 

response.” 

Mitigation 

Strategies 

Employed: 

Addressing state procurement and personnel systems: 

 “The state found it more expedient to hire temporary, yet less skilled, 

workers to meet immediate response needs rather than attempt full-time 

hires.” 

 “To mitigate the effects of being unable to immediately access PHER 

funds because of state budget and procurement processes, the health 

agency used other existing funding streams for procurement actions until 

the H1N1 supplemental funding was available. Once the PHER funds 

were available, H1N1 expenses were re-journaled to PHER funds; 

however, this practice restricted use of the original funding streams until 

the re-journaling could occur. This delayed implementation of normal 

programmatic activities until late in the grant year.” 

 “Health agency program staff tried to educate fiscal staff within the 

health agency and in the state’s department of administration about the 

necessity to process H1N1-realted requests quickly.” 

 “The federal government needs to recognize that state requirements can 

impose obstacles to speedy implementation of federal goals. Frequently, 

the principal remedy was issuance of executive orders under the 

emergency powers of the Governor to suspend procedural requirements 

for H1N1 activities. However, such executive orders can be difficult to 

obtain.” 

Recommendations 

Suggested: 

Emergency declaration in place: 

 “Even where there is a gubernatorial declaration of emergency in place, 

the declaration must clearly include a waiver of procurement/hiring 

policies and laws. State agency staffs in relevant agencies must be 

informed and educated about the effects of the emergency declaration on 

their regular procurement and hiring activities.” 

No emergency declaration in place: 

 “States need to look at actions it can take in situations where there is not 

statewide emergency declaration, such as enacting an exemption from 

statutory and administrative contracting procedural requirements for 

federal funds expended for purposes of public health emergency 

preparedness and response. Absent that, the issuance of needed 

emergency orders could be facilitated by a requirement imposed by the 

federal funding agency that such orders, or statutory exemptions, are in 

place as a precondition to receipt of the federal money.” 
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Association of State and Territorial Health Officials Page 144 

 “Statutory changes both at the state and federal level will be necessary 

for some jurisdictions wishing to change their procurement/personnel 

processes, especially in states in which emergency declarations are 

narrowly defined and agencies are not permitted to bypass normal 

processes.” 

Expediting state processes: 

 “Changes are needed in state hiring and procurement processes, so that 

purchases made with federal funds necessary for the state’s response to 

an event can be expedited, as compared to the usual lengthy procedure 

required when purchasing using state funds.” 

 “There is a need to identify and assess state and local laws or policies 

governing procurement and personnel to determine how these could be 

modified to improve emergency response activities. The relevant laws or 

policies would include those preventing the recruitment, hiring, or 

retention of the public health professionals necessary to respond to 

H1N1 (e.g., merit system, furloughs, hiring freezes, posting 

requirements, contractor v. FTE, etc.), as well as state/local procurement 

laws or policies hindering response to H1N1 (e.g. competitive bidding).” 

 “There is a need to identify additional policy/legal strategies that states 

can use to expedite the use of federal grant funds issued in response to a 

national emergency, even if an emergency declaration has not been 

issued in a state.” 

[Sources: Survey: X Meetings: Environmental Scan: X ] 

Pandemic Influenza Planning 

Issue: F.5 Pandemic influenza planning has been geared toward a worst-case 

scenario but must become more flexible and scalable to allow for 

pandemics of less virulent influenza viruses. 

Issue Type: Policy 

Level: Federal; State 

Discussion: A number of respondents acknowledged that “pandemic influenza planning 

has been geared toward a worst-case scenario; plans outlined courses of 

action that were not appropriate for this pandemic.” This disconnect between 

planning and the realities of the H1N1 outbreak “resulted in confusion when 

health department response actions did not reflect what was in the pandemic 

plans.” Because plans were developed under a worst-case scenario, “various 

assumptions and response strategies had to be changed to address the less 

virulent virus.” For example, “guidance for school closures and other 
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Association of State and Territorial Health Officials Page 145 

response activities had to be reworked to address the less severe H1N1 

outbreak.” The H1N1 outbreak demonstrated the need for flexible and 

staged pandemic response plans that align with the severity of the virus. 

States noted that “SNS pandemic response plans should be reviewed and 

revised to allow for graduated response levels.” It was noted that: “Since 

prior planning assumptions were based on a scenario that anticipated an 

H5N1 virus coming to the U.S. from Asia, plans had to be totally 

redeveloped. Plans that had focused on worst-case scenarios must now be 

considered from a less severe perspective with the potential to “ramp up.” 

Jurisdictions will need to exercise plans that are revised using the lessons 

learned from the H1N1 outbreak.” 

Mitigation 

Strategies 

Employed: 

 States adjusted their strategies based on the less severe circumstances 

posed by H1N1. States revised their strategies for community mitigation 

and recommendations related to school attendance/closures. 

Recommendations 

Suggested:  “Pandemic plans need to be revised to account for pandemic outbreaks 

with a less severe virus.” 

 “Pandemic plans need to be updated to include differing levels of 

pandemic severity, with clearly defined actions for each level.” 

 “Review and re-calibrate the current pandemic planning guidance, 

including the pandemic severity index and the definitions of the 

pandemic stages.” 

 “Pandemic plans need to be more strategic and written to allow health 

departments to adjust response strategies based on the situation and its 

impact on the jurisdiction.” 

 “In the future, federal plans must be more nimble, guided by situational 

awareness, real-world input from state and local stakeholders, and be 

based on the best available scientific expertise.” 

 “Regarding SNS planning, states need to conduct flexible, scalable 

exercises that are based on scenarios that are less than worst case 

scenarios.” 

 “Update the HHS Pandemic Influenza Plan to reflect new WHO phases 

and changes.” 

 “Provide guidance to states seeking to revise state operational pandemic 

influenza plans.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

 
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Association of State and Territorial Health Officials Page 146 

III.G Communication 

Please see the introduction to Section III on page 34 for general information about the data contained in 

this subsection. 

Summary of Barriers Identified

The primary barriers identified related to communication issues were (numbering does not reflect a 

priority order for the barriers): 

G.1 Messaging Coordination and Capacity–Federal, state and local governments need to 

achieve and maintain more consistent communications practices and messaging during 

emergency responses. 

G.2 Ad Campaigns and Messaging–Inconsistent and slow federal messaging and ad 

campaigns complicated state/local efforts to communicate about H1N1 response 

activities. 

G.3 Public and Media Outreach–Delayed federal decision-making and inconsistent 

messaging created significant public and media outreach demands on the states. 

G.4 Public and Media Outreach–Public health response activities were hindered by 

inconsistent messaging about the severity of the H1N1 outbreak.

G.5 Communication with Stakeholders–Federal, state and local agencies did not 

consistently and efficiently communicate with stakeholders during the H1N1 response. 

G.6 Outreach to Minority Communities and Special/Vulnerable Populations–Federal, 

state and local agencies needed to use more effective strategies to reach minority 

communities and special and vulnerable populations during the H1N1 outbreak. 

Selected Successes/Mitigations Identified 

Ad Campaigns 

 “The state created a robust media marketing campaign that focused on vaccine promotion and proper 

hygiene to prevent influenza spread. However, the delayed arrival of vaccine required state and local 

governments to adjust marketing strategies mid-course.” 

Media Relations 

 “Participants discussed and credited successful communication efforts during the H1N1 event with 

and/or between media outlets and state and local agencies.” 

 “State and local public health officials acknowledge the federal government for coordinating public 

health information with the national media during the initial phases of the outbreak.” 

 “The state health agency’s public information officer addressed media demands by setting a schedule 

of routine times for press briefings, and established conference calls for key groups involved on the 

response (e.g. local PIOs, local vaccine coordinators).” 
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Association of State and Territorial Health Officials Page 147 

Messaging Coordination 

 “Communications were strength during the nationwide response; however, some communication 

issues occurred.” 

 “The coordination of information was massively improved from spring to fall, in large part because of 

a state health Google Group implemented at the state level. This was developed to ensure that 

healthcare workers only received H1N1 updates once a day rather than each time a federal HAN was 

issued (multiple times a day during the spring response).” 

 “The state attempted to develop its own key message update when the daily CDC updates become too 

large and unmanageable.” 

Public Outreach 

 “Early communication of event details provided by the CDC and the state health agency via public 

media messages, conferences, briefings, interviews, broadcasts, website access and information, 

outreach messages (specifically about vaccination), laboratory result communication, as well as a 

high level of state participation (Governor and cabinet secretaries) were among the most successful 

means of communication during the incident.” 

 “The state successfully used a variety of mechanism to communicate about H1N1, including: 

state/local websites to control messages and provide information; activation of state/local call centers 

and hotlines; sharing of weekly disease reports on the state health agency’s public website; bimonthly 

calls with representatives of professional provider organizations; ongoing press briefings with the 

Governor and state health director; presentations at healthcare forums, community meetings and 

school activities; and use of reverse 911 for communicating school-based messages.” 

 “The state health agency and local health departments used social media sites, including Twitter and 

Facebook, to distribute messages.” 

 “The state health agency public website was designed to include a specific page for H1N1, 

information on which was updated regularly.” 

 “The state agency, under the auspices of the state’s H1N1 ICS command, developed a unit to monitor 

social media. 

 To overcome inconsistent messaging regarding federal versus state vaccination priorities, one state 

noted that it “issued repetitive statements, press, and sound bites both statewide and in local 

communities to reiterate the state’s priority strategy/approach.” 

 “The state health agency staged an aggressive public information campaign to encourage vaccination 

and to refute the claims that the vaccine was somehow experimental.” 

Communication with Stakeholders 

 One state health representative noted that it “conducted facilitated, structured conference calls with 

local health agencies during which updated written Q&As were distributed to provide H1N1 and 

related informational updates, and to address questions/concerns.” The state also “created a separate 

link on its HAN portal website for H1N1 guidance to facilitate local health departments’ ability to 

quickly find current H1N1 information from the state health agency.” 

 “The state health agency created the ability for the public and providers to register on the state’s 

website for automatic H1N1 information alerts.” 

 “The state shared relevant H1N1 materials to stakeholders through state distribution networks.” 
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Association of State and Territorial Health Officials Page 148 

Outreach to Minority Communities and Special/Vulnerable Populations 

 “Relying on health agency science experts to provide safety messages were not totally effective at 

dispelling vaccine safety concerns among all minority and special populations. States also had to get 

the word out to community leaders who could spread the message within their communities.” 

 “To address some physicians' reluctance to recommend the vaccine, a state health agency attempted 

to identify and characterize the reasons for the resistance. The state health agency partnered with a 

hospital association and provider groups to create and deploy a brief internet-based survey about 

physicians’ attitudes about the H1N1 vaccine and vaccines generally.” 

 “To reach minority communities specifically, health agency staffs have organized meetings between 

agency leadership and pastors, local African-American elected officials and other minority 

community leaders. This allowed department managers to learn first-hand about the concerns of 

minority constituents and to seek guidance about how to effectively address those concerns.” 

Barrier/Recommendations Identified Detail 

Messaging Coordination and Capacity 

Issue: G.1 Federal, state and local governments need to achieve and maintain 

more consistent communications practices and messaging during 

emergency responses. 

Issue Type: Policy 

Level: Federal; State 

Discussion: Coordination among governmental entities and maintaining agency capacity 

to effectively communicate were key issues for state health agencies. 

Federal Communications 

Large amounts of information were directed at state and local health 

agencies from multiple sources, and states found it was difficult to keep up 

with and take action on. Some commented that, “over time, CDC’s key 

message documents became too lengthy and this diluted their effectiveness 

as daily media updates”. Some also noted that “information for the public 

and providers on the CDC website could be confusing when the data and 

guidance was changing quickly.” 

Respondents noted that “federal delays in issuing, and frequent revision of, 

guidance in key policy areas like vaccine availability and formulation, 

vaccine priority groups, and PPE, delayed state response activities and 

caused states extra work in dealing with confused and concerned 

stakeholders, media and the public.” 

Locally Focused Communications 

Coordinating messages to local communities was an important concern. 

States encountered challenges in effectively communicating with local 

private health care providers to ensure consistent messaging because local 
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Association of State and Territorial Health Officials Page 149 

health departments’ knowledge and communications channels with 

providers varied greatly by locality. 

States expressed the need for “consistency between federal and state 

agencies regarding publicly communicating the names of local providers 

with vaccine.” In some states, the federal release of provider names was 

contrary to some states’ wishes; states were concerned about overwhelming 

local health care capacity. 

State Communications Capacity and Coordination 

States’ communications capacity and coordination activities should be 

addressed. States indicated that they “need to better coordinate state program 

staff with public information officers to allow for more and improved 

proactive messaging, rather than reactive messaging as some felt happened 

with H1N1.” 

 Using social/new media tools for public outreach: Some states were 

initially unable to use “new media” tools (e.g., Twitter, Facebook) for 

H1N1 outreach because of state information technology (IT) and records 

requirements. States noted that “use of such new communication 

vehicles were planned as part of their H1N1 media campaigns to reach 

targeted populations (i.e., children, adolescents, young adults).” One 

state noted, however, that its health agency and state IT policies did not 

generally allow use of social media such as Twitter, Facebook, 

MySpace, or instant and text messaging, in part because of difficulties in 

maintaining a public records trail as required by state policy and law. 

Although school-based and other community H1N1 vaccination clinics 

were generally successful, active use of and interface with social media 

tools could have further enhanced statewide outreach efforts to specific 

groups. 

 Balancing information release with privacy concerns: States noted 

challenges in balancing the need to release information to the public 

with the need to maintain privacy and protect resources from becoming 

overwhelmed. States had to weigh the level of detail to publicly provide 

when reporting confirmed H1N1 cases against individuals’ privacy 

considerations. 

States also cited “the lack of coordination by HHS/CDC with states 

regarding the agency’s intent to create a flu clinic locator.” One state 

noted that “CDC made public pronouncements anticipating the release 

of the names of vaccine providers without consulting states that had 

expressed a contrary point of view.” The state agency faced uncertainty 

while not knowing what CDC ultimately planned to do. 

Mitigation 

Strategies 

Employed: 

Volume of Communication Issues 

 “The state attempted to develop its own key message update when the 

daily CDC updates become too large and unmanageable.” 
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Association of State and Territorial Health Officials Page 150 

Social/New Media Issues 

 “The state agency, under the auspices of the state’s H1N1 ICS 

command, developed a unit to monitor social media. That unit worked 

with the agency’s IT department to get permission to passively observe 

social media trends and gather information on a daily basis for specific 

event reporting related to the H1N1 virus, non-availability/availability of 

vaccine, and adverse events and safety concerns. The resulting “social 

media report” was widely read by the ICS command, agency staff and 

local health departments throughout the course of the outbreak. One 

benefit identified was that by monitoring social media outlets, the state 

health agency was able to gauge public perception and behavioral 

changes related to H1N1. A limitation, however, was that due to the 

agency’s inability to actively interface with targeted Facebook and 

Twitter subscribers, it missed an opportunity to effectively use this 

public information tool to promote H1N1 vaccinations, address safety 

concerns, and quickly dispels rumors.” 

Recommendations 

Suggested: 

Volume of Communication Issues 

 “CDC should prioritize its key messages, with focus on current issues, 

and include additional background in an attached document.” 

 “CDC should summarize their revisions to HAN communications and 

guidance in bullets, clearly outlining changes made.” 

Federal Communications with States/Locals 

 “CDC should post a version number on every guidance document.” 

 “Reduce the number of conference calls.” 

 “Ensure that the same information is provided on all calls; make call 

notes available to everyone by posting these notes on a public website 

for everyone involved in the response effort to see.” 

 “Keep conference call times and days consistent.” 

State Communication Capacity and Coordination 

 “Ensure that public information officers (PIOs) submit up-to-date 

information on a regular basis rather than only on an "as requested" 

basis. Regular communication reports should be included as a 

requirement in emergency response cooperative agreements.” 

 “State health agency should continue to consolidate federal guidance for 

state and local partners during future large-scale events to ensure state 

and local partners are not overwhelmed by federal communications and 

to ensure that state and local communications are also being received.” 

Social/New Media Issues 

 “The state is currently drafting a statewide social media policy. When 
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Association of State and Territorial Health Officials Page 151 

approved, it will be provided to all state agencies for implementation. 

Within the health agency, the office of communications, in coordination 

with the health commissioner/chief medical officer, will review, revise 

and ultimately implement the policy in the health agency. The state 

health agency office of communications will provide the policy to all 

local health departments as a template for future use.” 

 “Develop guidance for use of social media so that stakeholders are not 

trying to learn how to best use it ‘on the fly’.” 

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Ad Campaigns and Messaging 

Issue: G.2 Inconsistent and slow federal messaging and ad campaigns 

complicated state/local efforts to communicate about H1N1 

response activities. 

Issue Type: Policy 

Level: Federal; State 

Discussion: Role of Federal Messaging/Campaigns in States’ Activities 

States acknowledged that federal messaging and ad campaigns were 

important elements in the states’ communication strategies for H1N1. 

 Need national presence to H1N1 ad campaigns: One respondent 

expressed that: “H1N1 advertising campaigns lacked a national 

presence. CDC relied on public service announcements and earned 

media, instead of a paid advertising campaign.” 

 Need to quickly share national ad campaign materials: There were 

delays in making nationally-produced advertisements available to states. 

For some states, “this greatly impeded the public education component 

of the overall response effort.” Additionally, once the advertisements 

were available to states, “it became clear that most were prohibited from 

being aired as paid advertisements, which was also problematic.” 

 Vaccination ad campaigns: States felt the need to “better coordinate 

federal/state/local vaccine ad campaign activities.” A respondent noted 

that “CDC was slow to announce it would not produce a paid, national 

advertising campaign, delaying the effort of states to plan and 

implement independent media strategies.” 

Inconsistent State/Federal Messaging

Some states felt that state and federal H1N1 campaigns lacked consistent 

messaging, which could be confusing to the public. 
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Association of State and Territorial Health Officials Page 152 

 Flu clinic locator messaging: It was unclear early on that HHS would 

invest in a flu clinic locator. One state created a flu clinic locator on its 

own, which was ready and operating ahead of the federal system. This 

state indicated that its “media campaign tied into its flu clinic locator, 

causing confusion among the public when the federal locator was 

advertised.” 

 Messaging about national vaccination priorities vs. state/local 

priorities: HHS/CDC presented messages nationally about vaccination 

priority groups, but each state and/or locality may have addressed 

priority groups differently (e.g., targeting some sub-priority groups 

first). States indicated that “these inconsistent messages presented 

challenges for the public and state/local agencies trying to implement 

vaccination clinics.” 

Mitigation 

Strategies 

Employed: 

Role of Federal Messaging/Campaigns in States’ Activities 

 “To overcome CDC delays in issuing an ad campaign, some states 

eventually developed and aired their own public service announcements, 

but the delays in doing so hindered their effectiveness. State PSAs were 

also developed without the benefit of knowing what was planned by 

CDC.” 

 “The state used paid advertising as another element of their overall 

communication plan, in addition to public service announcements and 

earned media.” 

Messaging About National Vaccination Priorities vs. State/Local Priorities

 To overcome inconsistent messaging regarding federal versus state 

vaccination priorities, one state noted that it “issued repetitive 

statements, press, and sound bites both statewide and in local 

communities to reiterate the state’s priority strategy/approach.” 

Recommendations 

Suggested: 

Ad Campaigns and Messaging 

 “CDC should actively partner with states, especially those with large 

media markets, to coordinate in planning federal influenza messages. A 

coordinated effort during the development of campaign themes would 

help assure that federal and state ad messaging is complementary.” 

 “There should be a hybrid effort in which CDC has a national 

advertising presence in addition to the effort of individual states.” 

 “The federal government should begin developing influenza-related 

public service announcements now (Spring 2010) to be available in Fall 

2010.” 

 “The rules regarding states’ use of federal ad materials should be made 

clear up front, even before they become available to the states.” 
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Association of State and Territorial Health Officials Page 153 

 “Allow CDC funds to be spent on media campaigns, as smaller counties 

could not afford PSAs and local politicians pushed back on placing this 

in local budgets.”

 “Streamline the clearance process at both the federal and state levels for 

messages to the public and to stakeholders.”

 “Allow greater flexibility with CDC funding, so that it can be used for 

timely messaging to the public.”

Vaccination Campaign 

 “Establish public information campaigns early in the response utilizing a 

unified consistent message.” 

 “Ensure that messaging for vaccine demand and excess vaccine supply 

are prepared ahead of time.” 

 “Increase public awareness and interest on getting vaccinated (develop 

focus group on why people did not get vaccinated).” 

 “Develop an outreach plan for the public to increase understanding of 

vaccine safety and the importance of being vaccinated.”

 “CDC, HHS, and other federal ad campaigns should make it a policy to 

address the safety and efficacy of the vaccine, and also include 

prevention strategies in their messaging.”

[Sources: Survey: X Meetings: X Environmental Scan: X ] 

Public and Media Outreach 

Issue: G.3 Delayed federal decision-making and inconsistent messaging 

created significant public and media outreach demands on the 

states. 

G.4 Public health response activities were hindered by inconsistent 

messaging about the severity of the H1N1 outbreak. 

Issue Type: Policy 

Level: Federal; State 

Discussion: Public/Media Outreach Activities and Needs 

Some of the most significant issues identified by states were the need for 

constant health agency communications with other agencies (federal, state 

and local), stakeholders and community groups, the media, and the public. 
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Association of State and Territorial Health Officials Page 154 

One state characterized the H1N1 outbreak as a “media outbreak,” which 

overwhelmed state agency systems that needed to respond to national, state 

and local media inquiries, as well as communicate with federal and local 

agencies, minority communities, providers and responders. Delays and 

changes in various guidances at the federal level “caused a ripple effect in 

states’ communication activities; each change required multiple messages to 

multiple groups.” 

States overwhelmingly identified the shifting timeline and changing 

messaging around H1N1 vaccine availability as causing significant 

communications issues. National efforts to push H1N1 vaccine before 

adequate supplies were available “created extra work and increased public 

distrust in government.” Others noted that “the lack of information about the 

status of vaccine supplies in the private health sector limited the state’s 

ability to effectively communicate where the public could be vaccinated.” 

Inconsistent messaging between federal and state/local health departments 

about vaccination priority groups likewise “caused confusion with the 

public, as did inconsistencies in vaccination priority strategies among 

neighboring states.” 

H1N1 Messaging/Severity Issues 

Differences in public health messaging about the H1N1 pandemic’s severity 

compared to how the outbreak was actually being experienced in various 

communities caused confusion and hindered the effectiveness of response 

activities. Public messaging “focusing on worst-case pandemic scenarios did 

not correspond with the public’s perception about the mild nature of the 

outbreak.” One respondent commented that: “Messaging that equated 

H1N1’s severity to that of seasonal influenza further complicated efforts at 

school closure/community mitigation activities. People did not take the 

direction to get an H1N1 vaccination as seriously as they should have 

because the severity of pandemic was low.” Some states noted that 

“inconsistent use and communication about the WHO pandemic phases and 

the HHS Pandemic Severity Index caused confusion relative to the H1N1 

outbreak.” 

Mitigation 

Strategies 

Employed: 

Public/Media Outreach Activities and Needs 

 “The state health agency’s public information officer addressed media 

demands by setting a schedule of routine times for press briefings, and 

established conference calls for key groups involved on the response 

(e.g. local PIOs, local vaccine coordinators).” 

Recommendations 

Suggested: 

H1N1 Messaging/Severity Issues

 “HHS/CDC should either use the pandemic response plan that it 

developed based on the Pandemic Severity Index or discard it and start 

over.” 

Messaging Coordination 

 “Need more consistent means of communication vetted with the public 

and public health partners (event naming and information, reliable 
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Association of State and Territorial Health Officials Page 155 

information on local media messages over local cable access and local 

government channel).” 

 “More efficient methods of intra-agency communication between public 

health partners, public information officers (PIOs) and the public are 

needed.” 

 “Need more efficient methods of communication between public health 

response partners (keeping certain information separate from public).” 

 “Local governments need to enhance partnerships with local media and 

communications outlets.” 

[Sources: Survey: X Meetings: X Environmental Scan: ] 

Communication with Stakeholders

Issue: G.5 Federal, state and local agencies did not consistently and efficiently 

communicate with stakeholders during the H1N1 response. 

Issue Type: Policy 

Level: State; Federal 

Discussion: Communication with Health Care Providers 

States noted challenges in communicating with health care providers during 

the H1N1 response: 

 Outreach to local health care providers: “Agencies encountered barriers 

to effectively communicate with non-health department providers across 

disciplines and across jurisdictions about H1N1 due to uncoordinated 

dissemination of information to private healthcare providers. The state 

health agency does not have current contact information for private 

healthcare providers or other local community organizations, or a 

process to maintain that information at the state level. Instead, the state 

health agency depends on local health departments to maintain 

communications with local healthcare providers. However, these 

communications are not always done consistently. As a result, some 

daycare providers received guidance late from the state about the 

importance of vaccination.” 

 Addressing misinformation: States had challenges dealing with 

misinformation communicated by some local providers. This 

misinformation caused confusion with the public and may have delayed 

some people from seeking vaccinations. A state noted that “one of its 

biggest communication challenges was addressing persistent rumors of 
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Association of State and Territorial Health Officials Page 156 

people who had been told by their physician, including OBs, that they 

should not get the vaccine because it was not safe.” 

 Guidance slow in going to health care providers: “From the perspective 

of health care providers, communication between the public health 

system and health providers was viewed as uncoordinated. During the 

outbreak, private practitioners reported that they did not receive CDC 

guidance documents in a timely fashion. Other providers noted that 

CDC guidance lacked clinically relevant information and was difficult to 

translate into practical instructions.”

 Interaction between public and private health counsel: “States identified 

the need for agency legal counsel and other agency response staff to 

develop and maintain communication with legal counsel and 

management to hospitals, health systems, and other traditional 

stakeholders, as well as with nontraditional organizations, such as 

churches, that assisted in the H1N1 response.” 

Communication with Stakeholders Generally 

States identified the need for better coordination and communication 

between federal and state efforts to distribute outreach materials to various 

stakeholder groups within the states and nationally. Some states indicated 

that they “were unaware of a coordinated approach to targeting 

stakeholders.” “CDC created materials for several audiences (e.g., church 

groups), but states were unclear about how and to whom CDC distributed 

those materials.” 

“With each emergency response activity, there is a renewed and ongoing 

need for outreach and education to quell persistent concerns of local health 

departments and volunteers about potential liabilities for emergency 

response activities, despite the existence of robust federal and state liability 

protections.” 

Mitigation 

Strategies 

Employed: 

Communication with Health Care Providers 

 One state health representative noted that it “conducted facilitated, 

structured conference calls with local health agencies during which 

updated written Q&As were distributed to provide H1N1 and related 

informational updates, and to address questions/concerns.” The state 

also “created a separate link on its HAN portal website for H1N1 

guidance to facilitate local health departments’ ability to quickly find 

current H1N1 information from the state health agency.” 

Communication with Stakeholders Generally 

 “The state health agency created the ability for the public and providers 

to register on the state’s website for automatic H1N1 information 

alerts.” 

 “The state shared relevant H1N1 materials to stakeholders through state 

distribution networks.” 
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Association of State and Territorial Health Officials Page 157 

Recommendations 

Suggested: 

Communication with Stakeholders Generally 

 “Coordination/communication among federal partners should be 

improved. Perhaps a national Joint Information Center could be 

established during national public health emergencies to improve realtime situational awareness and consistent messaging.” 

 “To avoid duplication of effort, CDC should share its plan of 

distribution for stakeholder materials before they are distributed. This 

will alert the states about where the materials are being targeted, allow 

states to suggest additional distribution channels, and avoid the potential 

for inconsistent federal and state messaging.” 

Communication with Health Care Providers 

 “Federal organizations need to do a better job communicating to medical 

providers about when and how to use antiviral medications, including a 

clear statement about inappropriate use of antivirals as a mass 

prophylactic agent.” 

 “Develop/identify contact lists for individual providers.” 

 “Target providers who treat high-risk populations.” 

 “Distill state guidance/changes to one page of bullet points that are sent 

with entire guidance document.” 

 “Prepare FAQs for office staff who answer the phones.” 

 “Establish relationships with pharmaceutical representatives to use them 

as an avenue for providing information to physicians/physician office 

staff.” 

[Sources: Survey: X Meetings: X Environmental Scan: ] 

Outreach to Minority Communities and Special/Vulnerable Populations 

Issue: G.6 Federal, state and local agencies needed to use more effective 

strategies to reach minority communities and special and 

vulnerable populations during the H1N1 outbreak. 

Issue Type: Policy 

Level: Federal; State 

Discussion: States noted the importance of outreach and messaging to minority and 

special/vulnerable populations. Federal, state and local agencies need to 
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“improve their outreach through trusted sources to address real and 

perceived problems with the H1N1 vaccine and public health vaccine 

activities in general.” States noted that “federal/state/local ad campaigns and 

messaging should be better coordinated.” 

Outreach to Minority Communities 

One respondent noted that “federal vaccine messaging to minority 

communities was conducted as a regular public health outreach campaign 

instead of using risk communication activities to assess areas of potential 

resistance and to construct messages to proactively overcome areas of 

resistance.” One state: “Experienced significant challenges in reaching some 

minority communities (particularly in metropolitan areas) and some rural 

populations with information about the need to be vaccinated against H1N1. 

African American and, to a lesser degree, Hispanic residents, expressed 

negative feelings or beliefs about the vaccine. Similar attitudes were 

observed in some rural communities. Feelings of fear, anger and distrust 

stemmed from a lack of confidence in the state and federal governments. 

Minority urban residents felt the vaccine was being forced on them without 

ample proof that the vaccine was safe. Some also expressed the belief that 

the severity of the pandemic did not warrant community-wide vaccination. 

These factors created a lack of trust in the vaccine’s safety, leading to very 

low vaccination rates among minority communities in the state. Internet 

blogs claiming that the vaccine was experimental or unsafe created further 

significant impediments to efforts to encourage widespread vaccination.” 

A health department found that: “Some physicians in minority communities 

did not trust the H1N1 vaccine. These physicians often did not receive the 

vaccine themselves and therefore did not recommend the vaccine for their 

patients. Because family physicians and other local health care providers 

carry a great deal of credibility in their communities, their negative opinion 

created pockets of public resistance against vaccination.” 

Outreach to Special and Vulnerable Populations 

Delayed coverage of vaccination costs for the uninsured coupled with slow 

messaging about this benefit delayed and limited vaccinations among this 

group. Another state noted that “it had challenges in reaching some rural 

populations with information about the need to be vaccinated against the 

H1N1 flu virus.” Some residents of rural communities were skeptical about 

the safety of the H1N1 and the need to get vaccinated. 

Overall Outreach Challenges 

State and local public health agencies were challenged in engaging priority 

groups and other members of the public in vaccination efforts, particularly 

those in minority populations. States noted the: “Lack of education, rumors, 

and myths about vaccine, and other cultural and socio-economic barriers in 

these populations made it difficult to reach them efficiently in large 

numbers. This resulted in decreased vaccination rates, delays in seeking 

vaccination, spread of misinformation, and ultimately disparate percentages 

of hospitalizations and deaths in minority patients with H1N1 compared to 
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Association of State and Territorial Health Officials Page 159 

non-minorities.” 

Mitigation 

Strategies 

Employed: 

Overall Outreach Challenges 

 “The state health agency staged an aggressive public information 

campaign to encourage vaccination and to refute the claims that the 

vaccine was somehow experimental.” 

 “Relying on health agency science experts to provide safety messages 

were not totally effective at dispelling vaccine safety concerns among all 

minority and special populations. States also had to get the word out to 

community leaders who could spread the message within their 

communities.” 

 “To address some physicians' reluctance to recommend the vaccine, a 

state health agency attempted to identify and characterize the reasons for 

the resistance. The state health agency partnered with a hospital 

association and provider groups to create and deploy a brief internetbased survey about physicians’ attitudes about the H1N1 vaccine and 

vaccines generally.” 

 “To reach minority communities specifically, health agency staffs have 

organized meetings between agency leadership and pastors, local 

African-American elected officials and other minority community 

leaders. This allowed department managers to learn first-hand about the 

concerns of minority constituents and to seek guidance about how to 

effectively address those concerns.” 

Recommendations 

Suggested:  “Follow well-established and proven risk communication strategies prior 

to launching public information and health education outreach 

campaigns focused on minority communities and special/vulnerable 

populations.” 

 “Work with leaders of faith-based groups in African-American 

communities and churches serving significant Latino populations.” 

 “Create greater engagement within minority communities by providing 

brochures to key social centers, such as churches, barber shops and 

beauty shops.” 

 “Increase emphasis on alternative media, both through news articles and 

advertising, such as media with primarily minority audiences as well as 

media aimed at rural areas.” 

 “Distribute general disaster preparedness materials to increase the state's 

credibility among skeptical populations.” 

 “States should develop communications policies that ensure outreach to 

communities that are culturally competent and address barriers to access 
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Association of State and Territorial Health Officials Page 160 

during an emergency. These policies should reflect input from these 

populations.” 

 “Generate guidelines about undocumented and/or migrant workers.” 

 “Provide information in languages besides from English and Spanish.” 

[Sources: Survey: X Meetings: X Environmental Scan: ] 

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Appendices 

Appendix 1: Project Advisory Panel Meeting Agenda and Attendees List 

Appendix 2: State Meetings Summary Report 

ASTHO H1N1 Policy Barriers Project State Meetings: Summary 

and Analysis 

Appendix 3: Survey Report 

ASTHO Survey of State Health Agencies on H1N1 Response 

Policy and Legal Issues: Summary and Analysis 

Appendix 4: Environmental Scan Report 

Environmental Scan of H1N1 Reviews and After-Action Reports: 

Identifying Policy and Legal Issues

   
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