DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General

Washihgton, D.C. 20201

I~H162010

TO: Thomas Frieden

Director

Centers for Disease Control and Prevention

FROM: Stuart Wright

Deputy Inspector General

for Evaluation and Inspections

SUBJECT: Memorandum Report: 2009 H1Nl School-Located Vaccination Program

Implementation, OEI-04-10-00020

This memorandum report provides information about selected 2009 HINI School-Located

Vaccination (SLV) programs. The Centers for Disease Control and Prevention (CDC) considers

SLY to be a viable, large-scale vaccination method for children. However, CDC indicated in

meetings with the Office of Inspector General (OIG) that onsite evaluations of the administration

of Hl N 1 vaccine at SLV sites would be useful because data about local implementation of SLV

programs have been limited, especially during influenza pandemics.

In November and December 2009, OIG conducted onsite interviews and observed the

administration ofRIN! vaccine at 38 selected elementary SLY sites in 6 localities. Our

evaluation of2009 HINl vaccination programs at these selected SLY sites included three

objectives: (1) to determine the extent to which SLY sites provided the first dose of the HINI

vaccine to enrolled students, (2) to determine the extent to which and how SLY sites

implemented specific vaccine administration elements, and (3) to identify challenges and lessons

learned from implementing these elements across SLY sites.

We found that, by locality, selected 8LV sites vaccinated an average of 28 percent of enrolled

students during their l-day programs, ranging from 14 percent to 45 percent. This compares

favorably to relevant State and national vaccination rates obtained over a longer period of'tirne

and through a variety of methods. For example, the average vaccination rate in the six

corresponding States was 37 percent. However, this statewide percentage reflects the number of

children vaccinated over a period of approximately 3 months using multiple methods (e.g.,

private providers, commercial pharmacies, mass vaccination clinics, SLV) and for a wider age

range. The majority of selected localities reported SLV to be a useful method to vaccinate a

large number of children ina short period of time, but they also reported that they would need

additional resources to implementfuture SLV programs.

OEI-04-10"00020 2009 BINI SLY Program Implementation

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DEPARTMENT OF HEALTH & HUMAN SERVICES Office of Inspector General

Washington, D.C. 20201

I~H 162010

TO: Thomas Frieden

Director

Centers for Disease Control and Prevention

FROM: Stuaii Wright 

Deputy Inspector General

for Evaluation and Inspections

SUBJECT: Memorandum Report: 2009 H 1 N 1 School-Located Vaccination Program

Implementation, OEI-04-IO-00020

This memorandum report provides information about selected 2009 HINI School~Located

Vaccination (SLV) programs. The Centers for Disease Control and Prevention (CDC) considers

SLY to be a viable, large-scale vaccination method for children. However, CDC ihdicated in

meetings with the Office of Inspector General (OIG) that onsite evaluations of the admÌnistration

of Rl N 1 vaccine at SL V sites would be useful because data about local implementation of SL V

programs have been limited, especially during influenza pandemics.

In November and December 2009, OIG conducted onsite interviews and observed the

administration ofRINl vaccine at 38 selected elementary SLY sites in 6 localities. Our

evaluation of2009 HINI vaccination programs at these selected SLY sites included three

objectives: (1) to determine the extent to which SLY sites provided the first dose of the BINI

vaccine to enrolled students, (2) to determine the extent to which and how SLY sites

implemented specific vaccine administration elements, and (3) to identify challenges and lessons

learned from implementing these elements across SLY sites.

We found that, by locality, selected 8L V sites vaccinated an average of 28 percent of emolled

students during their I-day programs, ranging fTom 14 percent to 45 percent. This compares

favorably to relevant State and national vaccination rates obtained over a longer period oftime

and through a variety of methods. For example, the average vaccination rate in the six

corresponding States was 37 percent. However, this statewide percentage reflects the number of

children vaccinated over a period of approximately 3 months using multiple methods (e.g.,

private providers, commercial pharacies, mass vaccination clinics, SLY) and for a wider age

range. The majority of selected !ocaHties reported SLY to he a useful method to vaccínate a

large number of children ina short period of time, but they also reported that they would need

addítional resources to im.plementfuture SL V programs.

OEI-04-10"00020 2009 BINI SLY Program Implementation
Page 2 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

 

We also found a number of challenges associated with implementing SLV programs. For 

example, we observed that the majority of selected SLV sites used recommended vaccine storage 

containers but did not monitor and record vaccine storage temperature. All selected localities 

reported challenges securing sufficient SLV staff and distributing them effectively across 

staffing functions. Additionally, selected SLV sites reported experiencing challenges 

communicating a clear and consistent message to parents about potential vaccination adverse 

reactions and the need for a second vaccine dose. Finally, the majority of selected localities had 

not established a billing system to bill third-party payers for the cost of H1N1 vaccine 

administration. 

The selected localities reported a number of things they would do differently in future SLV 

programs. These include simplifying the consent form and educational materials; standardizing 

the consent form review process; devoting more staff to registration, triage, and translation; 

streamlining staff communication and training; developing a centralized information-sharing 

system; and distributing information to parents and participating schools earlier. 

BACKGROUND 

In June 2009, the World Health Organization declared the start of the 2009 H1N1 influenza 

pandemic, and Congress appropriated supplemental funds to prepare for and respond to an 

influenza pandemic.1, 2 Although the pandemic was less severe than anticipated, approximately 

59 million cases were estimated nationwide from April 2009 to mid-February 2010.3 

Additionally, CDC estimated 265,000 hospitalizations and 12,000 deaths within the United 

States. Among children 17 years of age and younger, there were an estimated 19 million cases 

of H1N1 influenza, 85,000 related hospitalizations, and 1,250 deaths nationwide within the same 

timeframe. 

In July 2009, CDC announced funding to awardees through Public Health Emergency Response 

(PHER) grants to enhance State and local public health response capacity for emerging H1N1 

influenza outbreaks.4 CDC distributed a total of $1.35 billion through PHER grants in three 

phases.5 Awardees used the grant funds to plan for their 2009 H1N1 vaccination programs, 

1 World Health Organization, World Now at Start of 2009 Influenza Pandemic. Accessed at 

http://www.who.int/mediacentre/news/statements/2009/h1n1_pandemic_phase6_20090611/en/index.html on 

May 19, 2010. 

2 2009 Supplemental Appropriation Act, P.L. 111-32, Title VIII, 123 Stat. 1884 (June 24, 2009). 

3 CDC, CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations, and Deaths in the United States, April 

2009–February 13, 2010. Accessed at http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm on May 19, 2010. 4 Funding Opportunity Number CDC-RFA-TP09-902-H1N109, p. 1. 

5 Phase 1: On July 31, 2009, a total of $260 million was distributed to PHER awardees to help them assess their 

current capabilities in pandemic influenza response and to address remaining gaps. Phase 2: On August 21, 2009, 

$248 million was distributed to provide additional resources for mass vaccination planning and implementation 

activities. Phase 3: On September 28, 2009, $846 million was given for the implementation of mass vaccination 

programs. CDC, Funding Guidance and Technical Assistance to States. Accessed at 

http://www.bt.cdc.gov/cdcpreparedness/coopagreement/index.asp on May 19, 2010. 
Page 3 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

 

including purchasing supplies and hiring additional staff, such as contractors. Compared to SLV 

programs for seasonal influenza, the 2009 SLV programs were unique because of delays in 

vaccine production and delivery, compressed timelines for planning, and additional concerns 

about vaccine safety. 

In October 2009, upon availability of H1N1 vaccines, CDC began coordinating the distribution 

of limited quantities of two types of H1N1 vaccine: a nasal mist and an injection. The nasal 

mist was available for distribution in larger quantities before the injection, so States and 

localities initially received larger shipments of this type of the vaccine. According to CDC, the 

nasal mist should be administered only to people 2 to 49 years of age who do not have certain 

medical conditions, including asthma.6 The injection can be administered to people 6 months of 

age and older, including those with chronic medical conditions and pregnant women.7 

Individuals with a severe allergy to eggs, or any other substance in the vaccine, should not 

receive either type, as they may experience adverse reactions to it. 8 Finally, children 9 years of 

age and younger who are eligible to receive the vaccine based on the criteria above should 

receive two doses of the H1N1 vaccine, separated by a minimum of 21 days.9

Because of the initially limited supply of the H1N1 vaccine, CDC recommended voluntary 

vaccination of target group members (e.g., individuals ages 6 months to 24 years) to prevent 

illness among those at higher risk of infection and complications.10, 11 To implement CDC 

recommendations, States developed vaccination programs to reach target group members first. 

CDC’s recommendations allowed States and localities flexibility to determine how and when to 

vaccinate members of these target groups. Most States chose to direct H1N1 vaccine to 

individuals in the 6 month to 24 years of age target group and, as of early May 2010, 40 States 

had elected to reach this group using SLV to some degree.12

6 CDC, 2009 H1N1 Live, Attenuated Influenza Vaccine Information Sheet. Accessed at 

http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-laiv-h1n1.pdf on May 19, 2010. 

7 CDC, 2009 H1N1 Inactivated Influenza Vaccine Information Sheet. Accessed at 

http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-inact-h1n1.pdf on May 19, 2010. 

8 There have been rare and mild influenza-like side effects experienced after receiving the 2009 H1N1 vaccination. 

However, for those people with severe allergies to chicken eggs, anaphylactic shock resulting in death is possible. 

CDC, General Questions and Answers on 2009 H1N1 Influenza Vaccine Safety. Accessed at 

http://www.cdc.gov/h1n1flu/vaccination/vaccine_safety_qa.htm on May 19, 2010. 

9 CDC, Questions & Answers: Vaccine against 2009 H1N1 Influenza Virus. Accessed at 

http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm on May 19, 2010. 

10 CDC, 2009 H1N1 Vaccine Recommendations. Accessed at http://cdc.gov/h1n1flu/vaccination/acip.htm on 

May 19, 2010. 

11 Other target groups include pregnant women, caregivers of children younger than 6 months of age, health care 

and emergency medical service personnel, and persons aged 25 to 64 with certain health conditions that increased 

their risk of complications if infected with H1N1 influenza virus. 

12 Center for Infectious Disease Research & Policy, H1N1 Lessons Learned: Vaccination campaign weathered 

rough road, paid dividends. Accessed at 

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/apr3010campaign.html on May 19, 2010. 
Page 4 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Although some States implemented SLV programs during previous influenza seasons, the 2009 

influenza season was considered the first widespread use of SLV to vaccinate children against 

the influenza virus. CDC considers SLV to be a viable, large-scale vaccination method for 

children but indicated in meetings with OIG that onsite evaluations of the administration of 

H1N1 vaccine at SLV sites would be useful because data about local implementation of SLV 

programs have been limited, especially during influenza pandemics. 

School-Located Vaccination 

SLV is any vaccination program that takes place on school grounds. SLV usually targets 

enrolled students, although vaccine may be offered to others, such as school staff and family 

members of students and staff. SLV can occur before, during, and/or after school hours and 

involves collaboration between public health departments, schools, and/or school districts.13 

SLV programs may last a month or more within a State or locality, but vaccination at individual 

SLV sites is typically held for 1 day only. 

Several benefits are associated with conducting vaccination programs at schools. Schools 

provide a convenient location with large spaces, such as gymnasiums and cafeterias, to host the 

event. Schools also generally have well-established relationships with community members. 

Furthermore, school staff, including nurses, are familiar with students and their parents and can 

assist in contacting parents or calming nervous students.14

Federal Guidance for Administering H1N1 Pandemic Influenza Vaccine 

Guidance from the Department of Health & Human Services (HHS) and CDC outlines elements 

that State and local pandemic influenza planners should consider for vaccine 

administration.15, 16, 17 In a school setting, these elements include ensuring proper vaccine 

storage; distributing consent forms and verifying student vaccination eligibility (i.e., obtaining 

parental consent and verifying student medical eligibility), staffing the SLV site, communicating 

with parents, and billing for vaccine administration costs. 

Ensuring proper vaccine storage. To receive doses of the H1N1 vaccine, providers are required 

to sign the Vaccine Provider Agreement, which stipulates that they will store the vaccine 

according to the manufacturer’s Food and Drug Administration (FDA)-approved 

 

13 CDC, 2009 H1N1 Influenza School-Located Vaccination (SLV): Information for Planners. Accessed at 

http://cdc.gov/h1n1flu/vaccination/SLV/planners.htm on May 19, 2010. 14 Ibid. 

15 Ibid. 

16 CDC, Questions and Answers on 2009 H1N1 Vaccine Financing. Accessed at 

http://www.cdc.gov/H1N1flu/vaccination/statelocal/vaccine_financing.htm on May 19, 2010. 

17 HHS, HHS Pandemic Influenza Plan Supplement 6 Vaccine Distribution and Use. Accessed at 

http://www.hhs.gov/pandemicflu/plan/sup6.html on May 19, 2010. 
Page 5 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

package insert.18 The 2009 H1N1 package inserts state that both the nasal mist and the injection 

must be stored within the 35 degree Fahrenheit (°F) to 46°F (2° Celsius (C) to 8°C) temperature 

range.19 Influenza vaccines may become less effective if they are not stored in the 

environmental conditions specified by the manufacturer’s labeling insert. 

To ensure that the H1N1 vaccine is stored properly at SLV sites, CDC recommends that SLV 

planners place vaccine in containers, such as hard-sided or Styrofoam insulated coolers. CDC 

guidance also outlines appropriate packing methods for coolers, which include placing an 

insulated barrier between the vaccine and cold packs and ensuring that the thermometer used to 

monitor temperature does not touch the cold packs. Refrigerators, while not specifically 

recommended, may also be used but should be monitored for a week prior to vaccine storage to 

ensure that the appropriate temperature range can be maintained. Additionally, a thermometer 

must be kept in the refrigerator and no food or drinks may be stored inside. Vaccine storage 

temperature should be monitored and recorded every hour for coolers and twice each day for 

refrigerators.20

Distributing consent forms and verifying student vaccination eligibility. SLV staff is required to 

obtain parental consent prior to vaccinating students under the age of 18.21 To assist in this 

effort, CDC developed consent form templates that are available online for State and local 

pandemic influenza planners.22 After modifying the template for their needs, State and local 

planners may translate consent forms into other languages prior to distributing them to parents. 

Public health and partnering school officials may distribute consent forms to parents or guardians 

prior to the start of an SLV program (e.g., through mass mailings, sending forms home 

 

18 Copies of the official Vaccine Provider Agreement are not publicly available. However, a version of the Maine 

Vaccine Provider Agreement is available online at http://www.maine.gov/dhhs/boh/maineflu/h1n1/provideragreement-2009-2010.shtml. Accessed on May 11, 2010. General information is provided by CDC, 2009 Influenza 

(H1N1) Monovalent Vaccine: Vaccine Provider Agreement Q & A. Accessed at 

http://www.cdc.gov/H1N1flu/vaccination/statelocal/provider_agreement_qa.htm on May 20, 2010. 

19 FDA, Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients. Accessed at 

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccines/ucm186102.htm on May 19, 2010. 

20 CDC, Vaccine Storage and Handling Toolkit. Accessed at http://www2a.cdc.gov/vaccines/ed/shtoolkit/ on 

May 19, 2010. 

21 State laws govern the specific requirements for obtaining parental consent and SLV planners must develop 

consent forms in accordance with these laws. CDC, 2009 H1N1 Influenza School-Located Vaccination (SLV): 

Information for Planners, op. cit., p. 4. 22 CDC, Template 2009 H1N1 Vaccination Consent Form. Accessed at 

http://cdc.gov/h1n1flu/vaccination/slv/word/h1n1-im-consent-form.doc on May 19, 2010. 
Page 6 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

with children, and/or making forms available online).23, 24 Alternatively, if the SLV site is 

conducted outside normal school hours, when parents will be present to accompany their 

children, planners may distribute forms onsite. 

Prior to vaccinating students, SLV staff should review the consent forms to verify that parents 

have fully completed the forms. They can also use responses that parents provide to health 

history questions on the consent form to determine whether students are medically eligible to 

receive the vaccine and to determine whether the student should receive the nasal mist or 

injection. CDC’s consent form template includes questions to determine whether students have 

conditions that increase the risks associated with H1N1 vaccination, such as an egg allergy. 

Staffing. Local health departments coordinate staffing for SLV sites. However, SLV sites may 

have staffing needs that exceed the local health departments’ capacity. Because of this, CDC 

recommends that SLV planners (e.g., health department officials, school officials) consider 

recruiting additional medical and nonmedical staff, which may include hiring contractors (e.g., 

commercial community vaccinators).25 Other sources of SLV staff may include school 

employees (e.g., teachers, principals, school nurses) and volunteers (e.g., parents or Medical 

Reserve Corps members). Potential roles for these staff include distributing and collecting 

consent forms, communicating with parents, transporting the vaccine, assisting with patient flow, 

and administering the vaccine.26 SLV planners must also consider SLV staff’s training needs. 

This may range from onsite training for volunteers to medical training for vaccinators who do 

not typically treat children. 

Communicating with parents. CDC guidance indicates that Vaccine Information Statements 

(i.e., sheets produced by CDC that explain vaccination risks and benefits) should be included in 

the materials provided to parents before and after vaccination.27 These Vaccine Information 

Statements instruct parents how to properly respond to and report adverse reactions, if they 

occur. According to CDC, SLV planners can also communicate with parents about where to take 

their children to receive the second dose of the vaccine (e.g., at another SLV site, mass 

vaccination clinic, or a private provider).28 Additionally, planners are encouraged to inform 

 

23 Because consent forms are governed by State law, not Federal law, some jurisdictions may not be required to 

collect signed parental consent forms if the parent is present at the time of vaccination. As such, SLV planners may 

choose whether advance dissemination of consent forms is appropriate and/or necessary for their locality. For 

general information about guidelines for consent forms, see CDC, 2009 H1N1 Influenza School-Located 

Vaccination (SLV): Information for Planners, “Parental Consent Forms.” Accessed at 

http://cdc.gov/h1n1flu/vaccination/SLV/planners.htm on May 19, 2010. 24 SLV planners were permitted to distribute consent forms to parents in advance of the 2009 H1N1 Vaccine 

Licensure. For general information about optional advanced consent prior to vaccine licensure, see CDC, 2009 

H1N1 Influenza School-Located Vaccination (SLV): Information for Planners, “Optional Advanced Consent.” 

Accessed at http://cdc.gov/h1n1flu/vaccination/SLV/planners.htm on May 19, 2010. 

25 CDC, 2009 H1N1 Influenza School-Located Vaccination (SLV): Information for Planners. Accessed at 

http://cdc.gov/h1n1flu/vaccination/SLV/planners.htm on May 19, 2010. 

26 Ibid. 

27 Ibid., Vaccine Information Statements. 28 Ibid., Potential Sources of non-Public Health Department Staff and Ideas for Recruitment. 
Page 7 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

parents about the date their child was vaccinated and when he or she may need to receive a 

second dose of the vaccine (e.g., through an Influenza Vaccination Record card).29

Billing for vaccine administration. States and localities received the H1N1 vaccine and ancillary 

supplies (e.g., needles and syringes) from the Federal Government at no cost and therefore are 

not allowed to charge for the vaccine or ancillary supplies. However, States and localities are 

permitted to bill third-party payers (e.g., Medicare, Medicaid, private insurance companies) a set 

rate to cover certain costs associated with administering the H1N1 vaccine, such as staff salaries 

and liability insurance.30, 31, 32 To be reimbursed for these costs, SLV planners could collect 

health insurance information from parents (e.g., on the consent form) and submit claims to the 

appropriate third-party payers. CDC collaborated with the Centers for Medicare & Medicaid 

Services and other partners to facilitate reimbursement for H1N1 vaccine administration costs; 

however, some private insurance companies do not reimburse for these costs.33 Therefore, if 

SLV planners opt to bill third-party payers, they must identify the private insurance companies 

that reimburse for these services and incorporate their various billing codes into the SLV’s 

billing system. If SLV planners choose not to bill third-party payers for H1N1 vaccine 

administration costs, they can use other sources of funding (e.g., PHER grants) to cover all, or 

portions of, these costs. 

METHODOLOGY 

We determined the extent to which 38 elementary SLV sites in 6 localities provided the first dose 

of the H1N1 vaccine to enrolled students during their 1-day clinics. We also determined through 

onsite interviews and observations how these sites ensured proper vaccine storage, distributed 

consent forms, verified student vaccination eligibility, staffed the SLV sites, communicated with 

parents, and billed for vaccine administration. Additionally, we asked SLV planners to identify 

challenges and lessons learned from their 2009 programs, and potential changes to consider for 

SLV programs in future influenza seasons. 

Selection of Localities and SLV Sites 

We selected a purposive sample of 6 localities, which included 38 urban, elementary SLV sites. 

To select this sample, we first identified States conducting H1N1 SLV programs and determined 

whether they had previously implemented SLV programs. We selected States with varying 

 

29 CDC, Influenza Vaccination Record Card. Accessed at 

http://www.cdc.gov/h1n1flu/vaccination/slv/pdf/h1n1vaxrecord.pdf on May 19, 2010. 

30 CDC, H1N1 Vaccine Administration Billing Q & As. Accessed at 

http://www.cdc.gov/h1n1flu/vaccination/statelocal/vaccing_billing_qa.htm on May 19, 2010. 

31 The decision to bill for vaccine administration is made by the city, county, State, or commercial community 

vaccinator, not by individual schools. 

32 These set rates vary by State and provider, but are approximately $20 per vaccine administration. For an example 

of reimbursement rates for the 2009 H1N1 Influenza vaccine administration fees, see Highmark, 2009 

Reimbursement Fees: Flu, Pneumococcal and Hepatitis B Vaccines. Accessed at 

https://www.highmarkmedicareservices.com/partb/reimbursement/flu-pnu-hep-09.html on June 2, 2010. 

33 CDC, Questions and Answers on 2009 H1N1 Vaccine Financing, op. cit., p. 2. 
Page 8 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

levels of SLV experience to capture a range of procedures and the associated challenges and 

lessons learned. We then identified Metropolitan Statistical Areas (i.e., localities) within these 

States that had a population of at least 2.5 million residents.34 From this sample we selected six 

localities that had scheduled SLV clinics to provide the first dose of the H1N1 vaccine at 

elementary schools within our evaluation timeline (i.e., early November to mid-December 2009). 

We refer to these localities consistently throughout the report as Localities A, B, C, D, E, and F. 

See Appendix A for an alphabetical listing of the selected localities. 

We then selected six to eight elementary schools per locality based on the scheduled SLV date 

and time. We selected elementary schools because of their large grade range 

(i.e., pre-Kindergarten through sixth grade) and because their age demographics were consistent 

with children in an age range that CDC recommended receive a second vaccine dose (i.e., 

9 years of age and younger). See Appendix B for additional characteristics of the 38 selected 

SLV sites, by locality. 

Selection of SLV Elements 

Based on our review of HHS and CDC guidance and feedback from CDC staff, we selected five 

SLV elements to include in our evaluation: ensuring proper vaccine storage, distributing consent 

forms and verifying student vaccination eligibility, staffing, communicating with parents, and 

billing for vaccine administration. 

Data Collection 

To collect data for this study, we conducted onsite interviews with SLV staff and observed 

vaccine administration activities during the 1-day clinic at each selected school. We also 

administered followup surveys to SLV planners and reviewed documents collected from each 

SLV site and/or locality. 

Data collection instruments. We developed onsite interview and observation guides based on the 

five selected SLV elements. We also developed a followup survey for SLV planners to collect 

data regarding the number of students vaccinated and feedback regarding challenges and lessons 

learned from their 2009 programs and potential changes to consider for SLV programs in future 

influenza seasons. We coordinated with CDC to develop these data collection instruments. 

Interviews and observations. Between November 4 and December 15, 2009, we met with SLV 

planners in the six selected localities to collect relevant information about their SLV programs. 

We also conducted structured onsite interviews with SLV staff on the vaccination day. SLV 

staff included health department employees, contracted field managers, school nurses, contracted 

nurses, and school principals. In addition to the onsite interviews, we observed vaccine 

 

34 According to the U.S. Census Bureau (Census), Metropolitan Statistical Areas are geographic entities defined by 

the U.S. Office of Management and Budget for use by Federal statistical agencies in collecting, tabulating, and 

publishing Federal statistics. These areas contain a core urban area with a population of 50,000 or more. 

Additionally, they include the counties containing the core urban area as well as any adjacent counties that have a 

high degree of social and economic integration with the urban core. 
Page 9 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

administration during the 1-day clinic at each SLV site in our sample and collected data 

regarding the five SLV elements we selected (e.g., whether temperature monitoring devices were 

present, whether there was a system in place at the SLV site for verifying parental consent, the 

number of SLV staff serving in each staffing function). 

Followup surveys. In late December 2009, we emailed a followup survey to SLV planners in 

each of the six selected localities. We requested information regarding student enrollment, 

vaccine coverage rates for the first H1N1 dose by type of vaccine (i.e., nasal mist or injection), 

and information about how and where the locality would offer the second vaccine dose. We also 

asked SLV planners to identify challenges and lessons learned from their 2009 programs, and 

potential changes to consider for SLV programs in future influenza seasons. Finally, we 

requested supporting documentation, including SLV planning documents, onsite vaccine storage 

and handling procedures, parental consent form packages, and information provided to parents 

about potential adverse reactions and the need for a second vaccine dose. 

Data Analysis

To determine the extent to which and how selected SLV sites implemented the five selected SLV 

elements, we analyzed interview, observation, and followup survey data. We synthesized these 

data from these three sources to verify accuracy and to provide a more complete analysis. We 

present most of these data by locality because SLV programs and activities were generally 

similar across SLV sites in the same locality. However, where there were differences among 

SLV sites within a locality, we present these data by individual SLV sites. 

Percentage of enrolled students vaccinated in 1 day. To determine the extent to which selected 

SLV sites vaccinated enrolled students during their 1-day clinics, we calculated—across all 

38 SLV sites and by locality—the percentage of enrolled students that received the H1N1 

vaccine on the day of the SLV clinic.35 We also calculated, across all six corresponding States, 

the estimated statewide percentage of individuals 6 months to 17 years of age vaccinated.36 

Additionally, we calculated the percentage of students vaccinated with each type of vaccine, by 

locality. Finally, we calculated the number of selected localities that identified SLV as a useful 

vaccination model and reported that they would implement SLV programs in the future. 

Ensuring proper vaccine storage. We calculated the number of SLV sites that used coolers, 

refrigerators, or a combination of these methods to store the vaccine. We also calculated the 

number of SLV sites that had a temperature monitoring device and the number of SLV sites that 

used the device to monitor and record vaccine storage temperature. Finally—by type of storage 

container—we calculated the number of SLV sites that monitored and recorded vaccine storage 

temperature according to CDC guidelines and determined how frequently the monitoring and 

recording occurred. 

 

35 Using the enrolled student population for each locality, we weighted the percentage of students vaccinated to 

account for varying population sizes. 

36 Using the number of children under the age of 18 residing within the State based on 2008 Census data, we 

weighted the percentage of children vaccinated to account for varying population sizes. 
Page 10 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Distributing consent forms and verifying student vaccination eligibility. We calculated the 

average number and range of days prior to the vaccination day that consent forms were 

distributed, and we identified the most common distribution methods. Additionally, we 

calculated the number of SLV sites that distributed reminders to parents to return consent forms 

and identified the most common reminder methods. Finally, we calculated the number of SLV 

sites that verified student vaccination eligibility and identified the verification methods they 

used. 

Staffing. We consolidated and renamed staffing functions into the following categories based on 

similar job responsibilities, for consistency: vaccinator, triage, registration, special needs (which 

includes translators), manager, clerical, postvaccine, and other (e.g., security guards). We also 

consolidated and renamed the sources of onsite staff: Department of Health (i.e., local health 

department), Department of Education, contractor, other city agency, volunteer, and school 

nurse. Then, we calculated the average number and range of SLV staff across all selected SLV 

sites. We also identified the most common staffing sources and counted the number of SLV sites 

that reported using contractors. Additionally, we calculated the average number, average 

percentage, and range of staffing functions at all selected SLV sites. 

Based on our observations and interviews with onsite staff, we also identified where there were 

waiting lines of people (i.e., delays) at various points in the vaccination process, and we 

identified those delays by staffing function. We calculated the number of minutes it took for a 

child to proceed through the SLV site (i.e., vaccination time) and, when the vaccination time was 

longer than our site visit, we asked onsite staff to estimate the vaccination time for us. We 

categorized vaccination times as “long” if the processing time for a student was greater than 

45 minutes. 

Communicating with parents. We identified the most common methods to communicate with 

parents about potential adverse reactions associated with vaccination and the need for children 

9 years of age and younger to receive a second H1N1 vaccine dose. 

Billing for vaccine administration. We calculated the number of localities that billed third-party 

payers for vaccine administration and identified which payers they billed. We also described 

alternative approaches that the remaining localities used to pay for vaccine administration costs. 

See Appendix C for characteristics of SLV sites as they relate to these five selected elements. 

Limitations 

Our results are based on a purposive sample and therefore we cannot generalize to other SLV 

programs. 

The 1-day selected SLV clinics occurred at various stages in the localities’ H1N1 vaccination 

programs. For example, selected SLV sites in one locality were among the first to be held in that 

locality, while selected SLV sites in another locality were among the last to be held in that 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

 

locality. Because SLV planners typically adjusted their programs as time progressed, SLV sites 

we visited later may have had more opportunities to adjust and improve the overall program 

prior to our visits. 

The percentage of enrolled school children vaccinated at SLV sites on the day of our visit is 

based on self-reported data. The reported 1-day SLV rates may underestimate overall SLV 

first-dose vaccination coverage rates because schools may have also offered first doses at 

second-dose clinics. 

A number of factors influence vaccination rates, and we were not able to assess the effect of all 

of these variables. Such factors include the SLV date (e.g., relative to the timing and impact of 

H1N1 illness within the community), time (e.g., during or after school), and the type of vaccine 

available (i.e., injection or mist). Other factors may include the timing and methods of consent 

form distribution, collection, and review; as well as lack of knowledge about the vaccine. 

Additionally, community demographics and variations in media coverage of the influenza 

pandemic may influence vaccination rates. For example, in one locality, SLV planners observed 

an increase in returned consent forms after a number of local news stations extensively covered a 

child’s death because of H1N1. 

Standards 

This evaluation was conducted in accordance with the Quality Standards for Inspections

approved by the Council of the Inspectors General on Integrity and Efficiency. 

RESULTS 

Selected SLV Sites Vaccinated an Average of 28 Percent of Enrolled Students During Their 

1-Day Clinics 

Selected SLV sites vaccinated an average of 28 percent of enrolled students in 1 day. 

Additionally, they administered a slightly higher percentage of the H1N1 injection than nasal 

mist. Finally, the majority of localities reported that SLV is a useful vaccination method but said 

that they would not implement future SLV programs without additional resources. 

We found that, by locality, selected SLV sites vaccinated an average of 28 percent of enrolled 

students (5,910 of 20,862) in 1 day, ranging from 14 percent to 45 percent.37 Table 1 presents 

the average percentage and range of students vaccinated in 1 day at selected SLV sites by 

locality. The vaccination rate at selected SLV sites (28.3 percent) reflects the number of children 

vaccinated during a 1-day period using one method (i.e., SLV). In comparison, the average 

vaccination rate in the six corresponding States (37.3 percent) reflects the number of children 

vaccinated over a period of approximately 3 months using multiple methods (e.g., private 

37 Some of the percentages for individual SLV sites may be overestimated or underestimated if SLV planners 

expanded the group of people eligible to receive the vaccine (e.g., school-aged siblings) or if only a portion of the 

enrolled students (e.g., only certain grades) were eligible to receive the vaccine on the day of our site visit. See 

Appendix B for the groups eligible to receive the vaccine, by SLV site. 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

providers, commercial pharmacies, mass vaccination clinics, SLV) and for a wider age range.38 

The national median vaccination coverage rate for children aged 6 months to 18 years in the 

same 3-month period—nearly 37 percent—is similar to the average in these six States.39

Table 1: Average Percentage and Range of Students 

Vaccinated at Selected SLV Sites in 1 Day, by Locality 

Locality 

Average Percentage of 

Students Vaccinated at 

Selected SLV Sites 

Range of Percentage of 

Students Vaccinated at 

Selected SLV Sites 

A 44.7% 28.0%–67.4% 

B 29.6% 20.9%–37.6% 

C 28.1% 16.9%–41.0% 

D 22.6% 4.3%–37.9% 

E 17.5% 7.1%–25.1% 

F 14.4% 9.0%–33.2% 

Weighted Average 28.3% N/A 

Source: OIG analysis of H1N1 SLV data, 2010.

Of the reported total number of students vaccinated at selected SLV sites, approximately 

42 percent received the nasal mist and 59 percent received the injection. Table 2 shows the 

percentage of students vaccinated with each type of vaccine. Four localities offered both the 

nasal mist and injection to all students. Of these localities, three administered the nasal mist as 

the primary vaccine, provided that the student was eligible (e.g., had no underlying medical 

conditions, such as asthma), while the fourth locality gave parents the opportunity to choose 

which type of vaccine their child received. The remaining two localities chose to offer only the 

injection to certain elementary school grades because of high rates of these underlying 

conditions. Finally, three of the six localities reported a difference in demand between the 

injection and nasal mist because of parental and staff misconceptions about the safety of the 

nasal mist. For example, there were incorrect messages circulating in the media that the H1N1 

nasal mist could make recipients sick with influenza because it is a “live, attenuated vaccine.”40 

Localities reported that, as a result, some parents did not allow their children to receive the nasal 

mist. 

 

38 Estimate is based on data from CDC, Interim Results: State-Specific Influenza A (H1N1) 2009 Monovalent 

Vaccination Coverage—United States, October 2009–January 2010. Accessed at 

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5912a2.htm?s_cid=mm5912a2_e on May 20, 2010. 

39 Ibid.

40 Live, attenuated vaccines contain a weakened version of the influenza virus that is activated but will not cause 

illness. CDC, 2009 H1N1 Live, Attenuated Influenza Vaccine Information Sheet. Accessed at 

http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-laiv-h1n1.pdf on May 19, 2010. 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Table 2: Percentage of Vaccinated Students That Received 

Nasal Mist or Injection on Day of Site Visit, by Locality 

Locality 

Percentage of 

Students Vaccinated 

With Nasal Mist* 

Percentage of 

Students Vaccinated 

With Injection* 

E 73.8% 26.2% 

F 61.4% 38.6% 

B 58.8% 41.2% 

D 33.5% 66.5% 

C 28.7% 71.3% 

A 26.9% 73.1% 

Weighted Average 41.5% 58.5% 

* Differences in quantities and availabilities of each type of vaccine, along with parental 

preference, may have affected these percentages. 

Source: OIG analysis of H1N1 SLV data, 2010.

The majority of selected localities reported that SLV is a useful method to vaccinate a large 

number of children in a short period of time, but some said they will need additional resources to 

implement future SLV programs. Three of the six selected localities reported that they are likely 

to offer SLV in the future. Another two localities reported that they would consider offering 

SLV programs in the future only if they received Federal funding. These localities reported that 

SLV programs are very resource intensive and require dedicated full-time staff, sufficient 

funding to cover both vaccine and administrative costs, and ample planning time. One of these 

localities reported that it might choose to vaccinate school-aged children using a more traditional 

vaccination model that requires fewer resources, such as a community-wide, large-scale 

vaccination clinic. Finally, the remaining locality reported that it might offer SLV in the future, 

but only in a pandemic influenza scenario. 

The Majority of Selected SLV Sites Used Recommended Vaccine Storage Containers but 

Did Not Monitor or Record Vaccine Storage Temperature 

CDC recommends that SLV sites use hard-sided or Styrofoam coolers with cold packs to 

maintain vaccine storage temperature. Refrigerators, while not specifically recommended, may 

also be used to store vaccine if they can reliably maintain the required temperature range and 

have met other requirements described in CDC’s vaccine storage guidance.41 Twenty-nine of 

the thirty-eight SLV sites used coolers to store the vaccine. Three SLV sites used a combination 

of coolers and refrigerators, and all six SLV sites in one locality relied only on refrigerators. 

SLV planners in this locality reported experiencing some problems with faulty refrigerators that 

did not maintain the required temperature range. This caused some SLV sites to be rescheduled 

and compromised small amounts of the vaccine. Another locality considered using refrigerators 

at its SLV sites but opted against this because of concerns about cost and immobility. 

 

41 CDC, Vaccine Storage and Handling Toolkit, loc. cit. 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

The required temperature storage range for both types of the H1N1 vaccine is between 

35 and 46°F (2–8°C).42 CDC’s vaccine storage guidelines state that vaccine may become less 

effective if not stored in the temperature range required by its labeling.43 If SLV staff is not 

monitoring the vaccine storage temperature, they cannot ensure that the vaccine is stored 

properly and will be effective when administered. Approximately half of SLV sites (20 of 38) 

had temperature monitoring devices in the cooler or refrigerator with the vaccine. Of these sites, 

the majority (16 of 20) used thermometers. The remaining four sites used a color-coded 

temperature indicator that would change color if the temperature went outside of the required 

range. 

CDC also recommends that vaccine storage temperature be recorded, but only 12 SLV sites did 

so. Of the nine SLV sites that stored vaccine in coolers and recorded vaccine storage 

temperature, six did so hourly (i.e., consistent with the interval recommended by CDC), while 

the remaining three recorded the temperature every 2 hours. The three SLV sites that used 

refrigerators to store vaccines recorded temperature twice daily as recommended by CDC. 

Finally, we observed some vaccine storage procedures that were inconsistent with CDC’s 

vaccine storage and handling guidelines, which specify how coolers should be packed, 

monitored, and used.44 For example, we observed some SLV site staff leaving coolers open for 

extended time periods without monitoring temperature. We also observed tightly packed coolers 

that were missing spacers between the vaccine and cold packs, which could have caused the 

vaccine to become too cold. Additionally, we observed food items stored beside the vaccine and 

thermometers placed directly on top of or next to cold packs within the coolers, which can cause 

inaccurate temperature readings. 

All Selected Localities Used Parental Consent Forms To Verify Student Vaccination 

Eligibility, Although Most Reported That They Would Revise Their Procedures for Future 

Programs 

All selected SLV sites verified student vaccination eligibility prior to administering the H1N1 

vaccine and used various consent form distribution and eligibility verification procedures. SLV 

planners also reported a number of changes they would make to their consent form development, 

distribution, and review processes for future SLV programs. 

All SLV sites distributed, collected, and verified parental consent forms prior to vaccinating 

students. 

Consent Form Distribution, Collection, and Parent Reminders: The majority of SLV sites 

(32 of 38) made consent forms available to parents prior to the day of vaccination. These SLV 

sites made consent forms available an average of 29 days in advance (ranging from 7 to 61 days). 

In some cases, SLV sites reported that distributing consent forms before the day of vaccination 

 

42 FDA, Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and Ingredients, loc. cit. 

43 CDC, Vaccine Storage and Handling Toolkit, loc. cit. 44 Ibid. 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

presented vaccination challenges. For example, some students were vaccinated elsewhere 

(e.g., by a private provider) between the time the consent form was returned and the day of 

vaccination. Therefore, SLV staff had to determine whether the information parents provided on 

the consent form regarding immunization status was current. This typically was accomplished 

by calling the parents, which localities reported was time and labor intensive. 

Of the SLV sites that made consent forms available to parents prior to the day of vaccination 

(32 of 38), 5 used multiple methods to do so. The most common methods for making consent 

forms available in advance included sending them home with students (14 of 32) and making 

them available online (10 of 32). However, 3 of the 10 SLV sites that posted forms online also 

had forms available at the site because some parents did not have access to a computer and could 

not provide consent in advance through the online system. 

The majority of SLV sites (27 of 32) that distributed parental consent forms in advance also sent 

reminders to parents to return the consent forms. Approximately one-third (11 of 32) of SLV 

sites used more than 1 reminder method. These methods included mailing reminders home to 

parents and making personal or automated phone calls (10 of 32 SLV sites for each method). 

Finally, more than two-thirds (23 of 32) of SLV sites that distributed consent forms in advance 

collected completed forms by having students return them to their teachers or school nurses. 

The remaining six SLV sites distributed consent forms to parents on the day of vaccination. All 

of these sites were held after school. Distributing consent forms on the day of vaccination 

allowed parents to ask questions while completing the form. However, at most SLV sites that 

distributed consent forms on the day of vaccination, we observed long lines at registration. This 

appeared to be because of the amount of time it took for a parent to complete the consent form 

and ask questions. 

Consent Form Verification: Most of the selected SLV sites were held during school hours and 

did not require parents to be present. More than half of the SLV sites that distributed consent 

forms in advance (20 of 32) had nurses review the form upon receipt to identify any missing 

information. Additionally, all SLV sites conducted onsite reviews of the consent forms, which 

typically took place at registration and again immediately prior to vaccination. As a result of 

these review processes, several SLV sites also needed to call parents on the day of vaccination to 

complete or verify the information on the parental consent form. School nurses generally made 

these phone calls, which facilitated the process because they often knew the child and/or parent. 

However, planners reported that the additional step of calling parents required a substantial 

amount of time and is something they would try to avoid in future programs by standardizing the 

review process and training staff to use this process. The SLV sites that distributed consent 

forms on the day of vaccination were able to ensure completeness of consent forms more easily 

because the registration staff could verify the necessary fields while the parents were present. 

All 28 SLV sites held during school hours had procedures to match students to their consent 

forms, since the parents were typically not present. Approximately one-half of these SLV sites 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

(15 of 28) created a roster or list of students to identify those with parental consent. These SLV 

sites generally provided the roster to teachers or volunteers, who used it to determine which 

children to bring to the vaccination area. Other methods included relying on school staff to 

manually match children to their signed consent forms (8 of 28) and using both a roster and 

nametags (5 of 28) to identify those children with parental consent. 

All 38 SLV sites had procedures to identify children who had medical conditions that increased 

the risk of adverse reactions associated with H1N1 vaccination or a particular type of vaccine. 

For example, all of the consent forms included questions related to egg allergies and asthma. 

Across SLV sites, the vaccinators verified whether students had risk factors related to the 

vaccine and in some cases asked children additional questions (e.g., “Do you eat eggs for 

breakfast?” and “Do you use an inhaler?”) to ensure that they received the appropriate type of 

vaccine. 

SLV sites in all but one locality would change some aspects of their consent form development, 

distribution, and review processes for future SLV programs. SLV planners reported multiple 

consent form distribution methods and a high degree of collaboration between the Department of 

Health and the Department of Education to develop, print, and distribute program materials as 

overall program strengths. They also relied on schools’ past experiences communicating with 

parents. However, SLV planners specified a number of overall program challenges, including: 

 

 involving multiple agencies and/or individuals in the distribution, collection, and review 

of the consent forms; 

 formatting the consent forms to accommodate parents’ varying reading levels; 

 translating the consent forms; and 

 not adhering to the consent form return deadline. 

For future SLV programs, planners reported that they would simplify consent form packets by 

making the forms shorter and at a lower reading level and include only those materials that are 

medically and legally necessary. Planners would also make the consent form more versatile by 

including a field to record the second vaccine dose or creating an annual vaccination form that 

included influenza. Finally, planners would provide SLV staff with standardized training for 

collecting and reviewing consent forms. 

All Selected Localities Used Similar Staffing Functions and Sources; However, Each 

Encountered Challenges Securing Sufficient SLV Staff and Distributing Them Effectively 

Across Functions 

SLV planners in all six localities indicated that having sufficient staff was integral to the success 

of their H1N1 SLV programs. All selected SLV sites hired contractors to supplement staff from 

other sources. The three most commonly staffed functions at SLV sites were vaccinators, triage, 

and registration. Those sites that reported not having enough staff most often needed more 

registration staff, translators, and vaccinators. Table 3 presents the average number, average 

percentage, range, and a description of staffing functions at selected SLV sites. SLV planners 
Page 17 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

reported that they would make staffing changes for future SLV programs, including changing the 

distribution of staff across functions, improving staff communication, and providing additional 

training for SLV staff. 

Table 3: Staffing Functions at the 38 Selected SLV Sites

Average Staff 

Function Number* Percentage* Range Description of Staff Duties 

Vaccinator 4 31% 1–8 Vaccinate patients 

Triage 3 23% 0–14 Facilitate patient flow 

Registration 2 15% 0–5 Review consent forms and confirm patient 

identity 

Special 

Needs 1 8% 0–10 Provide services to patients with special needs, 

such as translation or learning disabilities 

Manager 1 8% 0–5 Control the operation of the SLV site 

Clerical 0 0% 0–4 Provide clerical services at the SLV site, such as 

data entry 

Postvaccine 0 0% 0–2 Monitor patients for potential adverse reactions 

after vaccination 

Other 1 8% 0–18 

Provide services that did not fall into any other 

category, such as security guards and quality 

assurance reviewers 

All Staff 13 4–33 

* Sums of columns do not equal totals because of rounding. 

Source: OIG analysis of H1N1 SLV data, 2010. 

All localities used contractors at SLV sites to supplement staff from other sources and reported 

challenges obtaining sufficient staff. SLV sites used an average of 13 staff, ranging from 4 to 33. 

All SLV sites used contractors in addition to staff from other sources, such as the local 

Department of Health, Department of Education, other city agencies, and/or volunteers. 

Contractors made up the largest source of staff at most SLV sites (27 of 38), averaging 

50 percent of staff across selected sites. The local Department of Health contributed the second 

largest average number of staff at SLV sites. 

SLV planners reported challenges obtaining a sufficient number of SLV staff. As a result, some 

SLV sites (7 of 38) encountered long vaccination times. Additionally, several localities reported 

problems with staff turnover or staff not showing up at the SLV sites; this resulted in a loss of 

experienced and trained staff, delays, and challenges with managing and redistributing staff. 

Additionally, two localities reported that the success of their SLV programs was dependent on 

school staff. However, schools in these two localities were not able to provide a sufficient 

number of staff because of budget constraints and lack of communication between SLV planners 

and school administrators. 
Page 18 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Localities experienced challenges distributing SLV staff across necessary staffing functions. 

SLV staff performed a variety of functions, and localities differed in how they distributed staff 

among these functions. Across all SLV sites, there was an average of four vaccinators, ranging 

from one to eight. The next most frequently staffed function was triage. SLV sites had an 

average of 3 staff performing triage functions, ranging from 0 to 14. The third most frequently 

staffed function at SLV sites was registration. SLV sites had an average of two registrars, 

ranging from zero to five. Two localities reported that it was helpful to use nurses at registration 

to prescreen children and review consent forms for completeness and accuracy because of their 

specialized training and knowledge of medical terminology and potential adverse reactions. 

SLV planners cited challenges related to staff composition, such as not having an effective 

distribution of staff members across functions. Some of the SLV sites (8 of 38) appeared to have 

sufficient staff but distributed them in such a way that delays occurred, usually at registration. 

We observed that all of the observed delays were because of a lack of registrars to review 

consent forms, translators to facilitate communication, or triage staff to help ensure clinic flow. 

Additionally, two localities reported that having an insufficient number of trained staff to review 

consent forms slowed the vaccination process. Delays at registration were especially apparent at 

after-school SLV clinics, where parents and siblings posed additional challenges with 

communication and crowd control. Appendix D includes the average percentage of staff in each 

SLV function, and the number of SLV sites that encountered long vaccination times and delays, 

by locality. 

The majority of localities reported that they would make changes to their staffing procedures in 

future SLV programs. For SLV programs in future influenza seasons, SLV planners reported 

that they would streamline communication among planners, school staff, and onsite staff. SLV 

planners in several localities reported challenges communicating, which resulted in 

misinformation and duplication of efforts. To remedy this, SLV planners said that they would 

clarify the roles of health department staff, school staff, and SLV site staff early in the process to 

ensure that all staff members knew with whom to communicate. 

SLV planners also recognized the need to provide more extensive guidance and training for SLV 

staff. SLV planners reported that they would provide additional guidance to school staff to help 

them better prepare for and operate the vaccination clinic. Additionally, they would provide 

more advanced training to nurses and clerical staff about the SLV process, vaccine storage and 

handling protocols, and how to more effectively review consent forms. 

Finally, SLV planners in one selected locality reported that allocating staff to the SLV program 

resulted in the interruption of regular school health services. In future programs, they plan to 

implement “continuity of operations plans to cover day-to-day school health operations” to more 

effectively allocate available staff for both activities. 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Selected SLV Sites Experienced Challenges Communicating a Clear and Consistent 

Message to Parents, Regardless of the Communication Method Used 

SLV sites informed parents about potential vaccine adverse reactions and the need for a second 

H1N1 vaccine dose in a number of ways. The majority sent information packets to parents by 

mail or home with students. However, most SLV planners reported that distributing this 

information was challenging, primarily because of a lack of clear guidance and procedures for 

communicating with parents. For future SLV programs, planners reported that they would make 

a number of changes, including providing additional training for those responsible for 

communication. 

SLV sites used similar methods for communicating with parents about potential adverse 

reactions and the need for a second vaccine dose. The most common method (23 of 38) of 

educating parents about potential vaccination adverse reactions was by sending information by 

mail or home with students. SLV sites also educated parents onsite (15 of 38) and through 

informational forums, television advertisements, and Web sites (11 of 38). Similarly, the most 

common method (16 of 38) used to educate parents about the need for children 9 years of age 

and younger to receive a second dose was by sending information to parents (e.g., on a 

vaccination card or information sheet), either by mail or home with students. Another method 

SLV sites reported using was making automated calls to parents (5 of 38). 

More than one-third of SLV sites (15 of 38) had not decided if and when they would offer the 

second dose. At these sites, no communication with parents about the provision of a second dose 

clinic occurred at the time of our site visit, and the only communication about the need for a 

second dose was a reference within the Vaccine Information Statements. However, by the time 

of our followup survey 2–6 weeks later, all six localities planned to conduct followup clinics to 

provide the second dose of the H1N1 vaccine to children 9 years of age and younger. Five 

localities planned to conduct followup clinics at the same school where they administered the 

first dose. The remaining locality planned to administer the second dose at mass vaccination 

clinics open to the entire community. 

SLV planners reported challenges conveying a clear and consistent message about vaccine safety 

and effectiveness and the need for a second vaccine dose. SLV planners reported that two 

significant communication challenges were not having (1) a procedure in place to share clear and 

consistent messages and (2) sufficient training for SLV staff. Our observations supported these 

reported challenges. For example, we observed an SLV staff member telling a school staff 

member that the nasal mist was a weaker type of the vaccine and she would need to receive 

multiple doses for it to be effective. 

One challenge specific to communicating with parents about the need for a second dose was a 

lack of quality control processes to ensure that children received the appropriate number of 

vaccine doses at the recommended time interval. For example, SLV planners in three localities 

reported that there was no centralized information-sharing system for private and public 

providers to be informed of a child’s vaccination status if the parent did not share that 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

 

information.45 A second related challenge reported by SLV planners was misinformation in the 

media, which made communicating a clear message to parents more difficult. For instance, SLV 

planners reported seeing or hearing inaccurate time intervals between the first and second doses, 

as well as the overall need for children 9 years of age and younger to receive a second dose.

To improve overall communication and encourage more parents to vaccinate their children, SLV 

planners suggested: 

 developing a centralized information-sharing system or utilizing existing systems; 

 establishing timelines for communication (e.g., when to distribute consent forms to 

parents, when to send reminders); 

 distributing information earlier (e.g., beginning of school year, up to 1 month prior to the 

vaccination clinic date); 

 providing more training to individuals responsible for communication; and 

 notifying participating schools when vaccinators will be onsite, what resources will be 

requested, and what responsibilities school staff members will have (e.g., contacting 

parents, collecting consent forms, setting up vaccination areas).

The Majority of Selected Localities Did Not Bill Third-Party Payers for H1N1 Vaccine 

Administration 

Four of six localities had not established a billing system to bill for H1N1 vaccine administration 

and instead used Public Health Emergency Response grant funding to cover vaccine 

administration costs. One of these four localities gathered health insurance information but had 

not decided whether it would bill third-party payers at the time of our visit. Another of these 

localities paid its contractor a lump sum for vaccine administration costs instead of an amount 

based on the actual cost of vaccinating the number of students that received the vaccine. 

SLV planners in this locality calculated this sum by assuming that 50 percent of the student body 

would be vaccinated and multiplying that number by a negotiated reduced fee.46

The remaining two localities billed third-party payers for H1N1 vaccine administration. 

However, while Medicare and Medicaid reimbursed vaccination administration costs, some 

private insurance companies did not. One locality collected the vaccination fee from 

parents (i.e., $15 in the locality) when a child’s insurance did not cover the vaccine 

administration cost.47 The other locality reimbursed its contractor for the vaccine administration 

costs incurred by uninsured children and those children whose insurance did not cover the 

administration cost. 

45 Immunization registries can be used to share information regarding a child’s immunization status. However, we 

did not assess whether data from the selected SLV sites were entered into immunization registries. 

46 SLV planners reported that the negotiated per person fee ($10) is approximately half of the Medicare vaccine 

administration fee in that region. 

47 CDC guidance states that public health clinics and mass vaccination sites conducted on behalf of a public health 

entity should not charge out-of-pocket expenses to patients. CDC, H1N1 Vaccine Administration Billing Q & As, 

Response to Question 2,” op. cit. 
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OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Both localities that billed for vaccine administration used contracted companies that specialized 

in providing vaccination services to the community (i.e., commercial community vaccinators) 

with established billing systems. However, these commercial community vaccinators reported 

that it was challenging to get insurance companies to reimburse for vaccine administration costs. 

For example, commercial community vaccinators found it time consuming to identify insurance 

companies who would reimburse for vaccine administration fees and to adapt their billing system 

to accommodate each third-party payer’s billing codes and reimbursement rates. Additionally, 

SLV planners commented that it was difficult for SLV staff to fill out all of the necessary billing 

paperwork onsite. 

CONCLUSION 

We found that, by locality, selected SLV sites vaccinated an average of 28 percent of enrolled 

students during their 1-day programs, ranging from 14 percent to 45 percent. This compares 

favorably to relevant State and national vaccination rates obtained over a longer period of time 

and through a variety of methods. For example, the average vaccination rate in the six 

corresponding States was 37 percent. However, this statewide percentage reflects the number of 

children vaccinated over a period of approximately 3 months using multiple methods 

(e.g., private providers, commercial pharmacies, mass vaccination clinics, SLV) and for a wider 

age range. The majority of selected localities reported SLV to be a useful method to vaccinate a 

large number of children in a short period of time, but they also reported that they would need 

additional resources to implement future SLV programs. 

We also found a number of challenges associated with implementing SLV programs. For 

example, we observed that the majority of selected SLV sites used recommended vaccine storage 

containers but did not monitor and record vaccine storage temperature. All selected localities 

reported challenges securing sufficient SLV staff and distributing them effectively across 

staffing functions. Additionally, selected SLV sites reported experiencing challenges 

communicating a clear and consistent message to parents about potential vaccination adverse 

reactions and the need for a second vaccine dose. Finally, the majority of selected localities had 

not established a billing system to bill third-party payers for the cost of H1N1 vaccine 

administration. 

The selected localities reported a number of things they would do differently in future SLV 

programs. These include simplifying the consent form and educational materials; standardizing 

the consent form review process; devoting more staff to registration, triage, and translation; 

streamlining staff communication and training; developing a centralized information-sharing 

system; and distributing information to parents and participating schools earlier. 

Our data indicate that SLV can be a viable strategy for vaccinating a large number of students in 

a short period of time. However, SLV programs require a significant amount of planning and 

resources. To help mitigate challenges in future SLV programs, SLV planners will need 

specific, timely guidance for each of the SLV elements we reviewed and sufficient lead time to 
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address them. See Appendix E for a list of SLV planning considerations that CDC may take into 

account when determining useful SLV practices and assisting States and localities that are 

interested in conducting SLV programs. 

This report is being issued directly in final form because it contains no recommendations. If you 

have comments or questions about this report, please provide them within 60 days. Please refer 

to report number OEI-04-10-00020 in all correspondence. 
Page 23 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Appendix A 

Selected Localities* 

Locality (State) 

Alexandria (VA) and Arlington (VA) 

Baltimore (MD) 

Minneapolis (MN) 

New York City (NY) 

Phoenix (AZ) 

St. Louis (MO) 

* Selected localities are listed in alphabetical order and do not appear in this 

order throughout the rest of the report. 

Source: Office of Inspector General analysis of H1N1 School-Located 

Vaccination data, 2010. 
Page 24 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Appendix B 

Characteristics of Selected School-Located Vaccination Sites 

Locality

SchoolLocated 

Vaccination 

(SLV) Site 

SLV 

Date 

Number of 

Students 

Enrolled at 

SLV Site 

Number of 

First H1N1 

Vaccine Doses 

Administered 

at SLV Site 

Type of 

Vaccine 

Available 

Groups Eligible 

To Receive 

Vaccine in 

Addition to 

Enrolled Students 

SLV Site 

Timing (i.e., 

held during 

or after 

school) 

School 1 11/4/09 688 369 Inj & Mist Staff After 

School 2 11/4/09 534 187 Inj & Mist Nonenrolled 

students; Staff After 

School 3 11/5/09 490 269 Inj & Mist Staff During 

School 4 11/5/09 900 314 Inj & Mist Staff During 

School 5 11/5/09 950 266 Injection Staff During 

School 6 11/5/09 694 374 Inj & Mist Nonenrolled 

students; Staff During 

School 7 11/5/09 572 222 Inj & Mist Staff After 

School 8 11/5/09 687 463 Inj & Mist Staff After 

A 

Locality A 5,515 2,464 

School 1 11/23/09 494 167 Inj & Mist N/A During 

School 2 11/23/09 607 228 Inj & Mist N/A During 

School 3 11/24/09 794 166 Inj & Mist N/A During 

School 4 11/24/09 624 194 Inj & Mist N/A During 

School 5 11/24/09 351 111 Inj & Mist N/A During 

School 6 11/24/09 560 150 Inj & Mist N/A During 

B 

Locality B 3,430 1,016 

School 1 11/12/09 410 111 Inj & Mist N/A During 

School 2 11/12/09 580 98 Inj & Mist N/A During 

School 3 11/13/09 485 89 Inj & Mist N/A During 

School 4 11/12/09 421 128 Injection N/A During 

School 5 11/12/09 681 279 Injection Staff (pregnant) During 

School 6 11/13/09 390 130 Injection N/A During 

C 

Locality C 2,967 835 

School 1 12/14/09 192 20 Inj & Mist N/A During 

School 2 12/14/09 284 49 Inj & Mist N/A During 

School 3 12/14/09 360 123 Inj & Mist N/A During 

School 4 12/15/09 483 21 Inj & Mist Staff During 

School 5 12/15/09 285 88 Inj & Mist N/A During 

School 6 12/15/09 404 153 Injection N/A During 

D 

Locality D 2,008 454 

School 1 11/20/09 555 96 Inj & Mist 

Siblings; 

Nonenrolled 

students 

After 

School 2 11/19/09 651 46 Inj & Mist Siblings After 

School 3 11/19/09 616 70 Inj & Mist Siblings After 

School 4 11/19/09 610 96 Inj & Mist Siblings After 

School 5 11/19/09 903 227 Inj & Mist Siblings After 

School 6 11/20/09 1,245 267 Inj & Mist 

Siblings; 

Nonenrolled 

students 

After 

E 

Locality E 4,580 802 

School 1 12/03/09 268 24 Inj & Mist N/A During 

School 2 12/03/09 821 81 Inj & Mist N/A During 

School 3 12/03/09 372 52 Inj & Mist N/A During 

School 4 12/04/09 357 49 Inj & Mist N/A During 

School 5 12/04/09 294 50 Inj & Mist N/A During 

School 6 12/04/09 250 83 Inj & Mist N/A During 

F 

Locality F 2,362 339 

Source: Office of Inspector General analysis of H1N1 SLV data, 2010.
Page 25 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation Appendix C School-Located Vaccination Site Characteristics Based on Interview and Observation Data 

Vaccine Storage Staffing Consent Form Distribution & Verification of Eligibility Communicating With Parents 

Locality 

SchoolLocated 

Vaccination 

(SLV) Site 

Type of 

Vaccine 

Storage 

at SLV 

Site 

Vaccine 

Storage 

Temperature 

Monitored & 

Recorded 

Number 

of Staff 

at SLV 

Site 

Method of 

Distributing 

Consent 

Forms 

Days Between 

Consent Form 

Distribution & 

Vaccination 

Method of 

Distributing 

Vaccine 

Information 

Statements 

Method of 

Informing About 

Second Dose 

Wil

Offe

S

School 1 Cooler No 12 Online; 

onsite 

Unknown by 

respondent 

Online; onsite; 

other 

Online; 

vaccination card 

School 2 Cooler No 8 Online 9 Email; phone; 

other 

Undecided 

School 3 Cooler No 7 Online Unknown by 

respondent 

Email; onsite; 

other 

Undecided 

School 4 Cooler No 13 Online 11 Other; answer 

questions 

Online; 

vaccination card 

School 5 Cooler No 10 Online 8 Other Undecided School 6 Cooler No 8 Online Unknown by 

respondent 

Online; onsite Onsite 

School 7 Cooler No 8 Online; 

onsite 

14 Email; answer 

questions 

Undecided 

School 8 Cooler No 16 Online; 

onsite 

 7 Unknown Unknown by 

respondent 

A 

Locality A 10 (avg.) 10 days (avg.) Yes 

School 1 Fridge Yes 9 Unknown by 

respondent 

35 Consent form Vaccination card 

School 2 Fridge No 14 Mail 29 Consent form Vaccination card School 3 Fridge Yes 8 Unknown by 

respondent 

28 Consent form Undecided 

School 4 Fridge Yes 11 Unknown by 

respondent 

31 Consent form Undecided 

School 5 Fridge No 15 Child 27 Email; answer 

questions 

Email 

School 6 Fridge No 15 Child 61 Consent form Phone; 

vaccination card 

B 

Locality B 12 (avg.) 35 days (avg.) 
Page 26 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation Appendix C School-Located Vaccination Site Characteristics Based on Interview and Observation Data (Continued) 

Vaccine Storage Staffing Consent Form Distribution & Verification of Eligibility Communicating With Parents 

Locality SLV Site 

Type of 

Vaccine 

Storage 

at SLV 

Site 

Vaccine 

Storage 

Temperature 

Monitored & 

Recorded 

Number 

of Staff 

at SLV 

Site 

Method of 

Distributing 

Consent 

Forms 

Days Between 

Consent Form 

Distribution & 

Vaccination 

Method of 

Distributing 

Vaccine 

Information 

Statements 

Method of 

Informing About 

Second Dose 

Wil

Offe

S

School 1 Cooler 

& fridge 

No 17 Mail 27 Consent form; 

other; answer 

questions 

Vaccination card 

School 2 Cooler 

& fridge 

No 15 Online; mail 24 Consent form; 

onsite; other 

Vaccination card 

School 3 Cooler 

& fridge 

No 16 Mail; online 23 Consent form; 

phone 

Vaccination card 

School 4 Cooler Yes 9 Child 28 Consent form N/A: vaccinated 

only children >9 

years old 

School 5 Cooler Yes 13 Child 18 Other; answer 

questions 

Undecided 

School 6 Cooler Yes 10 Child 29 Consent form; 

other; answer 

questions 

Vaccination card 

C 

Locality C 13 (avg.) 25 days (avg.) 

School 1 Cooler No 5 Child 30 Consent form Vaccination card; 

Undecided 

School 2 Cooler No 5 Child 34 Consent form; 

onsite 

Undecided 

School 3 Cooler No 6 Child 28 Consent form; 

onsite 

Undecided 

School 4 Cooler No 7 Child 8 Consent form; 

onsite 

Undecided 

School 5 Cooler No 4 Child 30 Consent form; 

onsite 

Undecided 

School 6 Cooler Yes 6 Child 30 Consent form Undecided 

D 

Locality D 6 (avg.) 27 days (avg.) 
Page 27 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation Appendix C School-Located Vaccination Site Characteristics Based on Interview and Observation Data (Continued) 

Vaccine Storage Staffing Consent Form Distribution & Verification of Eligibility Communicating With Parents 

Locality SLV Site 

Type of 

Vaccine 

Storage 

at SLV 

Site 

Vaccine 

Storage 

Temperature 

Monitored & 

Recorded 

Number 

of Staff 

at SLV 

Site 

Method of 

Distributing 

Consent 

Forms 

Days Between 

Consent Form 

Distribution & 

Vaccination 

Method of 

Distributing 

Vaccine 

Information 

Statements 

Method of 

Informing About 

Second Dose 

Wil

Offe

S

School 1 Cooler Yes 33 Onsite 0 Onsite Undecided School 2 Cooler Yes 31 Onsite 0 Onsite Phone; 

vaccination card 

School 3 Cooler Yes 33 Onsite 0 Onsite Phone; 

vaccination card 

School 4 Cooler No 30 Onsite 0 Onsite Phone School 5 Cooler Yes 30 Onsite 0 Onsite Undecided School 6 Cooler Yes 30 Onsite 0 Onsite Phone; 

vaccination card 

E 

Locality E 31 (avg.) 0 days 

School 1 Cooler No 7 Child 39 Consent form Vaccination card School 2 Cooler No 8 Child 49 Consent form Vaccination card School 3 Cooler No 6 Other 49 Consent form Vaccination card School 4 Cooler No 7 Unknown by 

respondent 

50 Consent form Vaccination card 

School 5 Cooler No 6 Child 50 Consent form Vaccination card School 6 Cooler No 5 Unknown by 

respondent 

29 Consent form Vaccination card 

F 

Locality F 7 (avg.) 44 days (avg.) 

Source: Office of Inspector General analysis of H1N1 SLV data, 2010. 
Page 28 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation Appendix D Staff and Staffing Functions at Selected School-Located Vaccination Sites, Long Vaccination Times, and Delays, b

Average Percentage of Staff in Each School-Located Vaccination Staffing Function* 

Locality 

Average 

Number of 

Staff at Each 

Selected 

SchoolLocated 

Vaccination 

(SLV) Site Vaccinator Triage Registration 

Special 

Needs Manager Clerical 

Postvaccine Other 

 SLV 

Ti

(i.e.

duri

sc

A 10 54% 9% 26% 6% 6% 0% 0% 0% DuB 12 39% 31% 19% 0% 7% 0% 3% 0% DC 13 36% 30% 14% 0% 6% 5% 3% 6% DD 6 36% 33% 15% 0% 12% 3% 0% 0% DE 31 15% 25% 11% 18% 8% 0% 2% 20%  Total  Average 13 31% 23% 17% 8% 8% 3% 2% 9% * Sums of percentages do not equal 100 percent because of rounding. ** Delays occurred at registration and were because of insufficient staffing in various roles related to processing consent forms and registration, as weproviding translation services. Source: Office of Inspector General analysis of H1N1 SLV data, 2010. 
Page 29 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

Appendix E 

School-Located Vaccination Planning Considerations 

The following planning considerations are based on observations, interviews, and surveys 

conducted at 38 selected School-Located Vaccination (SLV) sites in 6 localities during the 2009 

H1N1 influenza pandemic. The Centers for Disease Control and Prevention may consider this 

document when determining useful SLV practices and assisting States and localities that are 

interested in conducting SLV programs. Items are listed in semichronological order and cover 

topics that are important to consider when planning and implementing SLV programs. 

1. Identify school districts/individual schools that are interested in participating in the 

SLV program and involve parents and school staff early in the planning process. 

Once schools are identified, hold meetings with principals, teachers, school nurses, 

Parent Teacher Association members, providers, and other relevant stakeholders. For 

example, health department staff can give an overview of the SLV method and identify 

the respective responsibilities of the health department and schools during the program. 

These responsibilities may include: 

a. Health Department

i. Provide a diagram of the clinic, including setup and patient flow 

ii. Provide vaccine and related supplies 

iii. Identify and provide staff (e.g., managers, vaccinators) 

iv. Develop the consent form and educational materials 

b. Schools

i. Provide dedicated space for the SLV clinic and set up the space according 

to diagram provided by health department. 

ii. Identify and provide staff and/or parent volunteers (e.g., triage, 

translators). 

iii. Develop a plan for communicating with parents (e.g., informing them of 

the SLV program, distributing consent forms and educational materials 

provided by the health department). 

2. Consider that staffing needs are affected by SLV timing. We observed that SLV sites 

held during school hours tended to have lower attendance, possibly because of the fact 

that parents could not accompany students. However, we also observed that these sites 

were generally more organized because SLV staff could control the number of people in 

the vaccination area at any one time (e.g., by bringing one class in at a time). 

Alternatively, SLV sites held after school tended to have higher attendance because 

parents and siblings could accompany the enrolled student and, at some SLV sites, 

receive the H1N1 vaccine. However, we also observed that these sites were often 

overcrowded and poorly organized, which resulted in longer wait times. 
Page 30 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

3. Provide online and paper versions of the consent form. Online systems for 

completing consent forms can be convenient and efficient (e.g., because the system 

checks the consent form for completeness and eligibility before allowing parents to 

submit it). However, not all parents have access to a computer to complete the consent 

form online. Therefore, it may be beneficial to give parents the option to complete the 

online consent form at home and/or during a scheduled time in the school’s computer lab. 

Paper consent forms can also be provided to parents who would prefer this format over 

the online method. These paper forms should be reviewed in advance for completeness, 

preferably by one person within the health department or the school nurse to ensure 

consistency. 

To determine which method parents will use to complete the consent forms (e.g., online 

or hard copy), schools can communicate with parents to: 

(1) notify parents of the scheduled SLV clinic; 

(2) ask parents if they would like to complete the form online at home, online at the 

school, or use the paper format; and 

(3) provide parents the option to decline vaccination and explain why. Understanding 

why parents do not want their children vaccinated may allow SLV staff to dispel 

misinformation and improve future programs. 

4. Conduct a walk through of the SLV site prior to the event. This will give health 

department and school staff a chance to review the logistics for the event and address any 

concerns prior to the vaccination day. Health department and school officials may also 

want to schedule this time for parents to come in and complete the consent forms online. 

By scheduling these events at the same time, health department staff can answer 

questions or concerns that parents may have and eliminate the need for SLV planners 

and/or staff to make several trips to the school. 

5. Use automated phone calls and/or emails to remind parents to complete and return 

consent forms. This task may be delegated to the health department or the schools, 

depending on resources. Automated calls can be used to remind a large number of 

parents and may include information regarding the date parents can come to the school to 

complete forms, as well as the actual vaccination date. Automated email reminders 

(generated by the online registration system) may also be sent to parents who completed 

forms online. 

6. Pack vaccine coolers and supply kits the day before and have couriers deliver these 

items the day of the SLV clinic. Packing these items the day before and having couriers 

or other non-SLV staff deliver the items to the schools the day of the program saves time 

by eliminating the need for SLV staff to go to the health department before and after the 

event. Couriers can deliver the vaccine daily from the initial storage site (i.e., health 
Page 31 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

department or contractor’s office) to the SLV site. SLV planners in two of the three 

localities that used couriers reported that this method worked well for transporting the 

vaccine and supplies to the correct site without relying on SLV site staff. Other SLV 

sites used onsite staff to transport the vaccine or had the vaccine delivered directly from 

the manufacturer. SLV planners in three localities also noted that having health 

department employees prepackage the vaccines and supplies was helpful in saving time 

and ensuring that all needed supplies reached the SLV site. 

7. Monitor and record vaccine storage temperature according to the guidelines 

appropriate for the storage container (i.e., cooler or refrigerator). Once coolers have 

been transported to the SLV sites, the temperature inside the coolers should be monitored 

and recorded every hour; if vaccines are placed in refrigerators, the temperature should be 

monitored and recorded twice each day. SLV planners considering using refrigerators to 

store the vaccine should be aware of the additional cost, as well as accompanying 

mobility and storage issues (e.g., thermometer calibration). 

8. Ask school staff to set up the vaccination room, including privacy and waiting areas, 

before the health department or contracted vaccinators arrive. It may be more 

comfortable for students if privacy is provided for those being vaccinated. This may be 

done using screens or folding mats to create temporary walls between vaccination 

stations. Vaccination rooms can also have a waiting area for students to sit in before and 

after vaccination. Waiting areas may include toys, books, or videos to keep children 

occupied. Ensuring privacy and providing distractions in the waiting area can help calm 

students who may be nervous or upset. The day before, the health department may want 

to call schools to discuss any last-minute questions or concerns. 

9. Include principals, teachers, and/or school nurses when organizing SLV staff, and 

provide an adequate number of registrars, triage, health educators, and translators, 

based on community needs. Including the school staff can be helpful as they typically 

know the children’s parents and medical history. Additionally, school staff can often 

help as translators if non-English-speaking students or parents will be participating. By 

providing additional registrars, triage, and health educators, planners can avoid potential 

delays in patient flow. 

10. Ask registrars to use a roster that includes all of the students who returned a signed 

consent form. At the registration desk, students can be matched to the roster and asked 

to verify their identity. Once the student has been correctly identified, the registrar can 

give each student a copy of his or her consent form before he or she is escorted to the 

vaccination station. Planners may decide to use a color-coded system to identify which 

form of the vaccine, if any, a student should receive. For example, SLV sites in one 

locality used a color-coded sticker system to ensure that students received the proper type 

of vaccine; administrative staff placed a green, yellow, or red sticker on the consent form 

to indicate whether the student should receive the injection, mist, or no vaccine. For 
Page 32 – Thomas Frieden 

OEI-04-10-00020 2009 H1N1 SLV Program Implementation 

example, a form might receive a red sticker for “no vaccine” because the parent changed 

his or her mind, the child was vaccinated by his or her private provider in the interim, or 

the child was exhibiting influenza-like symptoms (e.g., fever). 

11. Make communication materials developed by Federal, State, and/or local agencies 

available to parents when they complete the consent forms as well as on the day of 

vaccination. It may be helpful if these materials are available in every language spoken 

by families at the school. Health departments can develop a sheet of frequently asked 

questions that dispels any rumors or misconceptions about the vaccine. Planners may 

want to review the reasons, if any, parents gave on consent forms for not vaccinating 

their children when developing this document. Once vaccinated, students should receive 

a Vaccine Information Statement that includes information about possible adverse 

reactions and a phone number to call if there are any questions. This sheet can also be 

sent home to parents of children who will need a second dose of the vaccine and include 

information regarding when and where the second dose will be administered. Once the 

child receives his or her second dose, he or she could take home a vaccination card 

including the administration date of both doses. Children who do not need a second dose 

can be sent home with the vaccination card or record the day that they are vaccinated. 

12. Determine whether it is beneficial to bill third-party payers for vaccine 

administration costs. Vaccine administration costs are typically paid through grant 

funding, State funds, or by billing third-party payers. While billing insurance companies 

enables health departments or contracted vaccinators to recoup some of their 

expenditures, it can be time consuming and requires a billing system to be in place, as 

well as a method for collecting insurance information (e.g., requesting that parents 

provide insurance information on the consent form).