~ DDEEPPAARRTTMMEENNTT OOFF HHEEAALLTTHH && HHUUMMAANN SSEERRVVIICCEESS OOffffiiccee ooff IInnssppeeccttoorr GGeenneerraall
f . E.
\..,'"~
~+'''4''''''C'''"'. WWaasshhinihggttoonn,, DD..CC.. 2200220011
I~H
162010
I~H 162010
TTOO:: TThhoommaass FFrriieeddeenn
DDiirreeccttoorr
CCeenntteerrss ffoorr DDiisseeaassee CCoonnttrrooll aanndd PPrreevveennttiioonn
FFRROOMM:: SSttuuaariit WWrriigghhtt 
DDeeppuuttyy IInnssppeeccttoorr GGeenneerraall
ffoorr EEvvaalluuaattiioonn aanndd IInnssppeeccttiioonnss
SSUUBBJJEECCTT:: MMeemmoorraanndduumm RReeppoorrtt:: 22000099 HH 11 NNl 1S Schcohoolo-Ll-oLcoacteadted VVaaccccininaatitoionn PPrrooggrraamm
IImmpplleemmenetnattaiotnio,n, OOEEII--0044--1IO0--0000002200
TThhiiss mmeemmoorraanndduumm rreeppoorrtt pprroovviiddeess iinnffoorrmmaattiioonn aabboouutt sseelleecctteedd 22000099 HHIINNII SScchhooool~l-LLooccaatteedd
Vaccination ((SSLLVV)) pprrooggrraammss.. TThhee CCeenntteerrss ffoorr DDiisseeaassee CCoonnttrrooll aanndd PPrreevveennttiioonn ((CCDDCC)) ccoonnssiiddeerrss
Vaccination 
SSLLYY ttoo bbee aa vviiaabbllee,, llaarrggee--ssccaallee vvaacccciinnaattiioonn mmeetthhoodd ffoorr cchhiillddrreenn.. HHoowweevveerr,, CCDDCC iihnddiiccaatteedd iinn
meetings with the Office of Inspector General (OIG) that onsite evaluations of tthhee aaddmmIinniissttrraattiioonn
meetings with the Office of Inspector General (OIG) that onsite evaluations of 
ooff RHll NN 11 vvaacccciinnee aatt SSLL VV ssiitteess wwoouulldd bbee uusseeffuull bbeeccaauussee ddaattaa aabboouutt llooccaall iimmpplleemmeennttaattiioonn ooff SSLL VV
pprrooggrraammss hhaavvee bbeeeenn lliimmiitteedd,, eessppeecciiaallllyy dduurriinngg iinnfflluueennzzaa ppaannddeemmiiccss..
IInn NNoovveemmbbeerr aanndd DDeecceemmbbeerr 22000099,, OOIIGG ccoonndduucctteedd oonnssiittee iinntteerrvviieewwss aanndd oobbsseerrvveedd tthhee
aaddmmiinniissttrraattioionn ooffRRIINN!l vvacacccininee ata t3388 sseelelecctteedd eelleemmeennttaarryy SSLLYY ssiitteess iinn 66 llooccaalliittiieess.. OOuurr
eevvaalluuaattiioonn ooff22000099 HHIINNIl vvacacccininaatitoionn pproroggrraammss aat tththeessee sseelelecctteedd SSLLYY ssiitteess iinncclluuddeedd tthhrreeee
objectives: (1) to determine the extent towhich SLY sites provided the first dose of tthhee HBIINNII
objectives: (1) to determine the extent to which SLY sites provided the first dose of 
vvaacccciinnee ttoo eennrroolllleedd ssttuuddeennttss,, ((22)) ttoo ddeetteerrmmiinnee tthhee eexxtteenntt ttoo wwhhiicchh aanndd hhooww SSLLYY ssiitteess
iimmpplleemmeenntteedd ssppeecciiffiicc vvaacccciinnee aaddmmiinniissttrraattiioonn eelleemmeennttss,, aanndd ((33)) ttoo iiddeennttiiffyy cchhaalllleennggeess aanndd lleessssoonnss
lleeaarrnneedd ffrroomm iimmpplleemmeennttiinngg tthheessee eelleemmeennttss aaccrroossss SSLLYY ssiitteess..
WWee ffoouunndd tthhaatt,, bbyy llooccaalliittyy,, sseelleecctteedd 88LL VV ssiitteess vvaacccciinnaatteedd aann aavveerraaggee ooff 2288 ppeerrcceenntt ooff eemnroolllleedd
ssttuuddeennttss dduurriinngg tthheeiirr Il--ddaayy pprrooggrraammss,, rraannggiinngg ffTroomm 1144 ppeerrcceenntt ttoo 4455 ppeerrcceenntt.. TThhiiss ccoommppaarreess
ffaavvoorraabbllyy ttoo rreelleevvaanntt SSttaattee aanndd nnaattiioonnaall vvaacccciinnaattiioonn rraatteess oobbttaaiinneedd oovveerr aa lloonnggeerr ppeerriioodd ooff'ttiimrnee
and through avariety ofmethods. For eexxaammppllee,, tthhee aavveerraaggee vvaacccciinnaattiioonn rraattee iinn tthhee ssiixx
and through a variety of methods. For 
ccoorrrreessppoonnddiinngg SSttaatteess wwaass 3377 ppeerrcceenntt.. HHoowweevveerr,, tthhiiss ssttaatteewwiiddee ppeerrcceennttaaggee rreefflleeccttss tthhee nnuummbbeerr ooff
cchhiillddrreenn vvaacccciinnaatteedd oovveerr aa ppeerriioodd ooff aapppprrooxxiimmaatteellyy 33 mmoonntthhss uussiinngg mmuullttiippllee mmeetthhooddss ((ee..gg..,,
pprriivvaattee pprroovviiddeerrss,, ccoommmmeerrcciiaall pphhaarrmacaiceiess, ,mmaassss vvaacccciinnaattiioonn ccllininicicss,, SSLLYV) )aanndd fofor raa wwidideerr aaggee
range. The majority of selected localities reported SLVto be auseful method to vaccinate a
range. The majority of selected !ocaHties reported SLY to he a useful method to vaccinate a
llaarrggee nnuummbbeerr ooff cchhiillddrreenn iinnaa sshhoorrtt ppeerriioodd ooff ttiimmee,, bbuutt tthheeyy aallssoo rreeppoorrtteedd tthhaatt tthheeyy wwoouulldd nneeeedd
aaddddiittiioonnaall rreessoouurrcceess ttoo iimm.pplleemmeennttffuuttuurree SSLL VV pprrooggrraammss..
OOEEII--0044--1100"0"000020020 22000099 BBIINNII SLSLYY PProroggrraamm IImmpplleemmeennttaattiioonn Page 2  Thomas Frieden  
 
 
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 
2009February 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 3  Thomas Frieden  
 
 
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.  
CDCs 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 4  Thomas Frieden  
 
 
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 manufacturers 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 5  Thomas Frieden  
 
 
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 46F (2 Celsius (C) to 8C) temperature 
range.19  Influenza vaccines may become less effective if they are not stored in the 
environmental conditions specified by the manufacturers 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/provider-
agreement-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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 6  Thomas Frieden  
 
 
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.  CDCs 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 staffs 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.  
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 7  Thomas Frieden  
 
 
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 SLVs 
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.   
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 8  Thomas Frieden  
 
 
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.   
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 9  Thomas Frieden  
 
 
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 calculatedacross all        
38 SLV sites and by localitythe 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.  Finallyby type of storage 
containerwe 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.   
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 10  Thomas Frieden  
 
 
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 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 11  Thomas Frieden  
 
 
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 
childs 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 1 2  Thomas Frieden  
 
 
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 periodnearly 37 percentis 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 
Average Percentage of  Range of Percentage of 
Students Vaccinated at  Students Vaccinated  at 
Locality  Selected SLV Sites  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 CoverageUnited States, October 2009January 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 13  Thomas Frieden  
 
 
Table 2:  Percentage of Vaccinated Students That Received 
Nasal Mist or Injection on Day of Site Visit, by Locality 
Percentage of  Percentage of 
Students Vaccinated  Students Vaccinated 
Locality  With Nasal Mist*  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 CDCs 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 14  Thomas Frieden  
 
 
The required temperature storage range for both types of the H1N1 vaccine is between  
35 and 46F (28C).42  CDCs 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 CDCs 
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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 15  Thomas Frieden  
 
 
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 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 16  Thomas Frieden  
 
 
(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 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 17  Thomas Frieden  
 
 
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 
Vaccinate patients 
Vaccinator  4  31%  18 
Facilitate patient flow 
Triage  3  23%  014 
Review consent forms and confirm patient 
Registration  2  15%  05 
identity 
Special  Provide services to patients with special needs, 
1  8%  010 
Needs  such as translation or learning disabilities 
Control the operation of the SLV site 
Manager  1  8%  05 
Provide clerical services at the SLV site, such as 
Clerical  0  0%  04 
data entry 
Monitor patients for potential adverse reactions 
Postvaccine  0  0%  02 
after vaccination 
Provide services that did not fall into any other 
Other  1  8%  018  category, such as security guards and quality 
assurance reviewers 
All Staff  13    433   
* 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. 
 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 18  Thomas Frieden  
 
 
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. 
 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 19  Thomas Frieden  
 
 
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 26 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 childs vaccination status if the parent did not share that 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 20  Thomas Frieden  
 
 
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 childs 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 childs 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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 21  Thomas Frieden  
 
 
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 payers 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 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 22  Thomas Frieden  
 
 
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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 23  Thomas Frieden  
 
 
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. 
 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 24  Thomas Frieden  
 
 
Appendix B 
 
Characteristics of Selected School-Located Vaccination Sites 
Number of  Groups Eligible  SLV Site 
School- Number of  
First H1N1  Type of  To Receive  Timing (i.e., 
Located  SLV  Students 
Locality  Vaccine Doses  Vaccine  Vaccine in  held during 
Vaccination  Date  Enrolled at 
Administered  Available  Addition to  or after 
(SLV) Site  SLV Site 
at SLV Site  Enrolled Students  school) 
School 1  11/4/09  688  369  Inj & Mist  Staff  After 
Nonenrolled 
School 2  11/4/09  534  187  Inj & Mist  After 
students; Staff 
School 3  11/5/09  490  269  Inj & Mist  Staff  During 
School 4  11/5/09  900  314  Inj & Mist  Staff  During 
A  School 5  11/5/09  950  266  Injection  Staff  During 
Nonenrolled 
School 6  11/5/09  694  374  Inj & Mist  During 
students; Staff 
School 7  11/5/09  572  222  Inj & Mist  Staff  After 
School 8  11/5/09  687  463  Inj & Mist  Staff  After 
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 
B  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 
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 
C  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 
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 
D  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 
Locality D          2,008  454       
Siblings; 
School 1  11/20/09  555   96  Inj & Mist  Nonenrolled  After 
students 
School 2  11/19/09  651   46  Inj & Mist  Siblings  After 
School 3  11/19/09  616   70  Inj & Mist  Siblings  After 
E  School 4  11/19/09  610   96  Inj & Mist  Siblings  After 
School 5  11/19/09  903  227  Inj & Mist  Siblings  After 
Siblings; 
School 6  11/20/09        1,245  267  Inj & Mist  Nonenrolled  After 
students 
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 
F  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 
Locality F    2,362  339       
Source:  Office of Inspector General analysis of H1N1 SLV data, 2010. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 25  Thomas Frieden  
 
 
Appendix C 
 
School-Located Vaccination Site Characteristics Based on Interview and Observation Data 
Consent Form Distribution 
    Vaccine Storage  Staffing  Communicating With Parents  Third-Party Billing 
& Verification of Eligibility 
Type of  Vaccine  Method of  Will Locality 
School- Number  Method of  Days Between 
Vaccine  Storage  Distributing  Method of  Offer Second  How Did Locality Cover 
Located  of Staff  Distributing  Consent Form 
Locality  Storage  Temperature  Vaccine  Informing About  Dose at  Vaccine Administration 
Vaccination  at SLV  Consent  Distribution & 
at SLV  Monitored &  Information  Second Dose  Same SLV  Costs? 
(SLV) Site  Site  Forms  Vaccination 
Site  Recorded  Statements  Sites? 
School 1  Cooler  No  12  Online;  Unknown by  Online; onsite;  Online;      
onsite  respondent  other  vaccination card 
School 2  Cooler  No    8  Online    9  Email; phone;  Undecided      
other 
School 3  Cooler  No    7  Online  Unknown by  Email; onsite;  Undecided     
respondent  other 
School 4  Cooler  No  13  Online  11  Other; answer  Online;     
questions  vaccination card 
School 5  Cooler  No  10  Online    8  Other  Undecided     
A 
School 6  Cooler  No    8  Online  Unknown by  Online; onsite  Onsite     
respondent 
School 7  Cooler  No    8  Online;  14  Email; answer  Undecided     
onsite  questions 
School 8  Cooler  No  16  Online;    7  Unknown  Unknown by     
onsite  respondent 
Locality A      10 (avg.)    10 days (avg.)      Yes  Bill third-party payers 
School 1  Fridge  Yes    9  Unknown by  35  Consent form  Vaccination card     
respondent 
School 2  Fridge  No  14  Mail  29  Consent form  Vaccination card     
School 3  Fridge  Yes    8  Unknown by  28  Consent form  Undecided     
respondent 
School 4  Fridge  Yes  11  Unknown by  31  Consent form  Undecided     
B 
respondent 
School 5  Fridge  No  15  Child  27  Email; answer  Email     
questions 
School 6  Fridge  No  15  Child  61  Consent form  Phone;      
vaccination card 
Locality B      12 (avg.)    35 days (avg.)      Yes  Undecided at the time of 
our visit 
Continued on next page
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 26  Thomas Frieden  
 
 
Appendix C 
 
School-Located Vaccination Site Characteristics Based on Interview and Observation Data (Continued) 
Consent Form Distribution 
    Vaccine Storage  Staffing  Communicating With Parents  Third-Party Billing 
& Verification of Eligibility 
Type of  Vaccine  Method of  Will Locality 
Number  Method of  Days Between 
Vaccine  Storage  Distributing  Method of  Offer Second  How Did Locality Cover 
of Staff  Distributing  Consent Form 
Locality  SLV Site  Storage  Temperature  Vaccine  Informing About  Dose at  Vaccine Administration 
at SLV  Consent  Distribution & 
at SLV  Monitored &  Information  Second Dose  Same SLV  Costs? 
Site  Forms  Vaccination 
Site  Recorded  Statements   Sites? 
School 1  Cooler  No 17  Mail  27  Consent form;  Vaccination card     
& fridge  other; answer 
questions 
School 2  Cooler  No 15  Online; mail  24  Consent form;  Vaccination card     
& fridge  onsite; other 
School 3  Cooler  No 16  Mail; online  23  Consent form;  Vaccination card     
& fridge  phone 
School 4  Cooler  Yes    9  Child  28  Consent form  N/A:  vaccinated     
C  only children >9 
years old 
School 5  Cooler  Yes 13  Child  18  Other; answer  Undecided     
questions 
School 6  Cooler  Yes 10  Child  29  Consent form;  Vaccination card     
other; answer 
questions 
Locality C      13 (avg.)    25 days (avg.)      Yes  Public Health Emergency 
Response (PHER) funding 
School 1  Cooler  No    5  Child  30  Consent form  Vaccination card;     
Undecided 
School 2  Cooler  No    5  Child  34  Consent form;  Undecided     
onsite 
School 3  Cooler  No    6  Child  28  Consent form;  Undecided     
onsite 
School 4  Cooler  No    7  Child  8  Consent form;  Undecided     
D 
onsite 
School 5  Cooler  No    4  Child  30  Consent form;  Undecided     
onsite 
School 6  Cooler  Yes    6  Child  30  Consent form  Undecided     
Locality D        6 (avg.)    27 days (avg.)      Yes  Lump sum to contractors; 
PHER funding 
 
Continued on next page
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 27  Thomas Frieden  
 
 
Appendix C 
 
School-Located Vaccination Site Characteristics Based on Interview and Observation Data (Continued) 
Consent Form Distribution 
    Vaccine Storage  Staffing  Communicating With Parents  Third-Party Billing 
& Verification of Eligibility 
Type of  Vaccine  Method of  Will Locality 
Number  Method of  Days Between 
Vaccine  Storage  Distributing  Method of  Offer Second  How Did Locality Cover 
of Staff  Distributing  Consent Form 
Locality  SLV Site  Storage  Temperature  Vaccine  Informing About  Dose at  Vaccine Administration 
at SLV  Consent  Distribution & 
at SLV  Monitored &  Information  Second Dose  Same SLV  Costs? 
Site  Forms  Vaccination 
Site  Recorded  Statements   Sites? 
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     
E 
School 5  Cooler  Yes  30  Onsite    0  Onsite  Undecided     
School 6  Cooler  Yes  30  Onsite    0  Onsite  Phone;     
vaccination card 
Locality E      31 (avg.)      0 days      Yes  Bill third-party payers 
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     
F  School 4  Cooler  No    7  Unknown by  50  Consent form  Vaccination card     
respondent 
School 5  Cooler  No    6  Child  50  Consent form  Vaccination card     
School 6  Cooler  No    5  Unknown by  29  Consent form  Vaccination card     
respondent 
Locality F        7 (avg.)    44 days (avg.)      No  PHER funding 
Source:  Office of Inspector General analysis of H1N1 SLV data, 2010. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 28  Thomas Frieden  
 
 
Appendix D 
 
Staff and Staffing Functions at Selected School-Located Vaccination Sites, Long Vaccination Times, and Delays, by Locality 
Average Percentage of Staff in Each School-Located Vaccination Staffing Function* 
Average  Number of 
Number of  Selected 
Staff at Each   SLV Site  SLV Sites 
Selected  Timing  That  Number of 
School- (i.e., held  Encountered  Selected SLV 
Located  during or  Long  Sites That 
Vaccination  Special  Post- after  Vaccination  Encountered 
Locality  (SLV) Site   Vaccinator  Triage  Registration  Needs  Manager  Clerical  vaccine  Other  school)  Times  Delays 
During & 
A  10  54%  9%  26%  6%  6%  0%  0%  0%  3  3** 
After 
B  12  39%  31%  19%  0%  7%  0%  3%  0%  During  1  0 
C  13  36%  30%  14%  0%  6%  5%  3%  6%  During  0  0 
D  6  36%  33%  15%  0%  12%  3%  0%  0%  During  0  2** 
E  31  15%  25%  11%  18%  8%  0%  2%  20%  After  2  3** 
   Total    
13  31%  23%  17%  8%  8%  3%  2%  9%   
   Average 
* 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 well as communication with parents, including 
providing translation services. 
Source:  Office of Inspector General analysis of H1N1 SLV data, 2010. 
 
 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 29  Thomas Frieden  
 
 
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. 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 30  Thomas Frieden  
 
 
 
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 schools 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 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 31  Thomas Frieden  
 
 
department or contractors 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 childrens 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 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation  Page 32  Thomas Frieden  
 
 
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). 
 
OEI-04-10-00020     2009 H1N1 SLV Program Implementation