Department of Health and Human Services
 
OFFICE OF 

 
INSPECTOR GENERAL 

 
 
 
 
 
 
V C
ACCINES FOR  HILDREN 

 
 
P :
 
ROGRAM   
 
 
V
ULNERABILITIES IN 

 
V  M  
ACCINE  ANAGEMENT
 
 
Daniel R. Levinson 
  
Inspector General
  
 
June 2012 

OEI-04-10-00430 
  
   
 
EXECUTIVE SUMMARY:  VACCINES FOR CHILDREN PROGRAM:  
VULNERABILITIES IN VACCINE MANAGEMENT  
OEI-04-10-00430 
 
 
WHY WE DID THIS STUDY 
 
The Centers for Disease Control and Preventions (CDC) Vaccines for Children (VFC) 
program provides free vaccines to eligible children through a network of 61 grantees and 
44,000 enrolled providers.  In 2010, approximately 82 million VFC vaccine doses were 
administered to an estimated 40 million children at a cost of $3.6 billion.  VFC providers 
must meet certain requirements for vaccine management, such as storing vaccines within 
required temperature ranges and monitoring expiration dates, to ensure that these 
vaccines provide children with maximum protection against preventable diseases.  These 
requirements are also intended to decrease VFC program fraud, waste, and abuse.        
 
HOW WE DID THIS STUDY  
 
Using CDC data, we selected a sample of 45 VFC providers from the 5 grantees with the 
highest volume of vaccines ordered in 2010.  We conducted site visits at these providers 
medical practice locations, interviewed their vaccine coordinators, and observed their 
vaccine management practices.  We also independently measured these providers 
vaccine storage unit temperatures for a 2-week period.  Finally, we interviewed the five  
grantees VFC program staff regarding their program oversight. 
 
WHAT WE FOUND 
 
Although the majority of storage temperatures we independently measured during a 
2-week period were within the required ranges, VFC vaccines stored by 76 percent of the 
45 selected providers were exposed to inappropriate temperatures for at least 
5 cumulative hours during that period.  Exposure to inappropriate temperatures can 
reduce vaccine potency and efficacy, increasing the risk that children are not provided 
with maximum protection against preventable diseases.  Thirteen providers stored 
expired vaccines together with nonexpired vaccines, increasing the risk of mistakenly 
administering the expired vaccine.  Finally, the selected providers generally did not meet 
vaccine management requirements or maintain required documentation.  Similarly, none 
of the five selected grantees met all VFC program oversight requirements, and grantee 
site visits were not effective in ensuring that providers met vaccine management 
requirements over time.    
 
WHAT WE RECOMMEND 
 
We recommend that CDC continue to work with grantees and providers to ensure that 
(1) VFC vaccines are stored according to requirements, (2) expired vaccines are 
identified and separated from nonexpired vaccines, (3) grantees better manage providers 
vaccine inventories, and (4) grantees meet oversight requirements.  CDC concurred with 
all four of our recommendations and noted that vaccination is one of the most successful 
public health tools in preventing and controlling disease.  
 
   
   
 
TABLE OF CONTENTS 
Objectives ................................................................................................................1 

Background..............................................................................................................1 

Methodology............................................................................................................8 

Findings..................................................................................................................14 

VFC vaccines stored by 76 percent of 45 providers we reviewed were  

exposed to inappropriate temperatures ............................................................14 

Sixteen of forty-five providers we reviewed had expired VFC vaccines ........17 

None of the 45 providers we reviewed met the vaccine management 

requirements in all 10 categories .....................................................................18 

None of the five VFC grantees we reviewed met all oversight requirements, 

and grantee site visits were not effective in ensuring that providers met     

VFC requirements over time ............................................................................21 

Conclusion and Recommendations ........................................................................25 

Agency Comments and Office of Inspector General Response .......................28 

Appendixes ............................................................................................................29 

A: 	Vaccines for Children Program  Vaccines and Required Storage        

Temperatures ..............................................................................................29 

B: 	Vaccines for Children Program  Vaccine Management Requirements        

for Providers...............................................................................................31 

C: 	 Five Vaccines for Children Program  Grantees  With Highest Vaccine    

Order Volumes  ...........................................................................................35 

D: 	Vaccines for Children Program Providers in the Five Selected Grantee 

Jurisdictions by Sample Selection Characteristics .....................................36 

E: 	 Selected Vaccines for Children Program Providers With Storage Units 

Outside the Required Temperature Range During a 2-Week Period .........37 

F: 	Vaccines for Children Program  Vaccine Management Requirements      

That Providers Did Not Meet.....................................................................41 

G: 	 Required Vaccines for Children Program Documents Not  

Provided by Providers................................................................................43 

H: 	Activities Missing From Selected Grantees  Vaccines for Children 

Program Fraud and Abuse Policies ............................................................45 

I:  Agency Comments......................................................................................46 

Acknowledgments..................................................................................................48
 
 
   
   
 
OBJECTIVE 
To determine the extent to which selected Vaccines for Children (VFC) 
program providers and grantees adhered to the Centers for Disease Control 
and Preventions (CDC) requirements for vaccine management.  
BACKGROUND 
The VFC program is a Medicaid benefit that provides free vaccines to 
eligible children.1,  2   The Centers for Medicare & Medicaid Services 
(CMS) delegates the programs implementation to CDC, which purchases 
VFC vaccines and distributes them to  VFC providers.3  CMS reimburses 
CDC for the cost of the vaccines and for program management.  In 2010, 
the program cost $3.6 billion and approximately 44,000 providers 
participated.4, 5   These providers ordered approximately 82 million VFC 
vaccine doses to administer to an estimated 40 million children.6, 7      
Children eligible to participate in the VFC program may not otherwise be 
vaccinated because of inability to pay.   They include Medicaid-eligible, 
uninsured, American Indian/Alaska Native, and/or underinsured children 
who receive care through a Federally Qualified Health Center (FQHC) or 
Rural Health Clinic (RHC).8, 9   In 2011, approximately 70 percent of 
VFC-eligible children were enrolled in Medicaid.10  
Vaccines administered through the VFC program are licensed by the Food 
and Drug Administration (FDA) and approved for program inclusion by 
CDC.11  Licensed vaccines are labeled with required storage temperature 
 
1   
Omnibus Budget Reconciliation Act of 1993, P.L. 103-66  13631.
 
2 
Social Security  Act (SSA),  1928(a); 42 U.S.C.  1396s(a).
  
3
 CMS, Delegation Memorandum, June 30, 1994. 
 
4
 Department of Health and Human Services,  CDC Justification of Estimates for Appropriation Committees, 

Fiscal Year 2011. 
   
5
 CDC, VFC:  Summary Reports,  2010.  Accessed at 

http://www2a.cdc.gov/nip/irar/grantee/granteeinfo.asp#grptg on September 27, 2011. 
 
6
 CDC, VFC vaccine dose data, provided by CDC on January 14, 2011. 

7
 CDC, national population estimate for  2011, provided by CDC on October 4, 2011. 
 
8  
CDC, VFC Operations Guide, Module 1: Overview, p. 1, 2011.  Accessed at 

http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on 
 
 
February 2, 2011.
 
9
 SSA,  1928(b)(2); 42 U.S.C.  1396s(b)(2).
 
10
 CDC, national population estimate for 2011, provided by CDC on October 4, 2011. 
   
11
 VFC vaccines must be approved by the Advisory Committee on Immunization Practices.  CDC, VFC: The
  
ACIP-VFC Vaccine Resolutions, 2010.  Accessed at http://www.cdc.gov/vaccines/programs/vfc/acip-vfc
resolutions.htm on September 13, 2010. 
 
 
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ranges and expiration dates.12   Vaccines must be stored within the required 
ranges to ensure that the vaccines maintain the highest possible level of 
strength (i.e., potency) and effectiveness (i.e., efficacy).  Additionally, 
vaccines must not be administered after their expiration dates because they 
may lose potency and efficacy, reducing their ability to provide maximum 
protection against preventable diseases.13  VFC vaccines protect children 
against 16 preventable diseases: 
   diphtheria     mumps 
   haemophilus influenzae type b    pertussis  
   hepatitis A     pneumococcal disease 
   hepatitis B     polio 
   human papillomavirus    rotavirus 
   influenza     rubella (German measles) 
   measles    tetanus  
   meningococcal disease    varicella (chickenpox) 
 
See Appendix A for a list of all VFC program-covered vaccines and the 
required storage temperature ranges.   
VFC providers may receive funding for the same program-covered 
vaccines through other public and private funding sources.  Additional 
public funding sources include the Section 317 grant program and State 
budgets.14   Alternatively, providers may purchase these vaccines with their 
own funds to administer to children who are not VFC-eligible (e.g., 
individuals with health insurance that covers the cost of the vaccines).  
Most providers store publicly and privately purchased vaccines in the 
same freezers and refrigerators.  Providers must distinguish publicly 
purchased vaccines from privately purchased vaccines to ensure that 
vaccines are administered to the corresponding populations.15  For 
 
12
 21 CFR  610.50, 610.53, and 610.60-62. FDA,  Vaccine Product Approval Process, 2009. Accessed at  
http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLA 
Process/ucm133096.htm on November 29, 2010.     
13
 Vaccine expiration dates may be extended with FDA approval if the manufacturer verifies the sterility and 
potency of the vaccine.  FDA, Vaccine Safety Questions and Answers. Accessed at 
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm133806.htm on          
January 24, 2012.    
14  
The Section 317 grant program consists of Federal discretionary funds that may be used to purchase vaccines 
for non-VFC-eligible populations (children and adults).  States may also contribute funds to purchase vaccines 
for these populations. CDC,  VFC Operations Guide, Module 8: Vaccine Accountability, p. 1, 2011.  Accessed 
at http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on 
February 2, 2011.  
15
 CDC, VFC Operations Guide, Module 6: Vaccine Management, p. 11, 2011.  Accessed at  
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.  
 
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example, providers must ensure and be able to document that only 
VFC-eligible children receive VFC-purchased vaccines.16    
VFC Program Management and Oversight 
CDC manages the VFC program through 61 grantees that implement the 
program at the State and local levels.  Grantees include all 50 State health 
departments as well as public health agencies in 6 metropolitan areas and 
5 U.S. territories and protectorates.17  Each grantee recruits and enrolls 
providers in its jurisdiction.  A variety of provider types participate, 
including private providers (e.g., individuals or groups), public health 
departments, FQHCs/RHCs, other public health clinics (e.g., maternal and 
child health programs), and private hospitals.18   Approximately 70 percent 
of VFC providers are private providers.19    
Provider Vaccine Management Requirements. VFC providers must 
perform required activities in 10 categories established in the Vaccine 
Management Module of CDCs VFC Operations Guide:20    
1.   Vaccine Storage Equipment 
2.   Vaccine Storage Practices 
3.   Temperature Monitoring    
4.   Vaccine Storage and Handling Plans      
5.   Vaccine Personnel  
6.   Vaccine Waste 
7.   Vaccine Security and Equipment Maintenance   
8.   Vaccine Ordering and Inventory Management   
9.   Receiving Vaccine Shipments 
10.  Vaccine Preparation   
 
16
 CDC, VFC Operations Guide, Module 3: Provider Recruitment and Enrollment, pp. 4-5, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011. 
17
 The six metropolitan public health agencies are those of Chicago, the District of Columbia, Houston, 
New York City, Philadelphia, and San Antonio.  The five territory  and protectorate public health agencies are  
those of American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands.  
CDC, VFC:  State/Territory VFC Coordinators. Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/contacts-state.htm on October 24, 2011.  
18
 CDC, VFC provider data, provided by CDC on August 22, 2010.  
19
 CDC, VFC/AFIX Activities Query Results, 2010. Accessed at 
http://www2a.cdc.gov/nip/irar/grantee/granteeinfo.asp#grptg  on October 4, 2011.   
20
 CDC, VFC Operations Guide, Module 6: Vaccine Management, pp. 6-11, 2011.  Accessed at  
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.  
 
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Appendix B lists all required vaccine management activities within each 
category.  For example, the Vaccine Storage Equipment category does not 
allow the use of dormitory (dorm)-style storage units for permanent VFC 
vaccine storage because such units are not able to reliably maintain 
temperatures within required ranges.21      
In addition, the VFC Operations Guide establishes documentation 
requirements for VFC providers.  Each provider must maintain the 
following documents related to vaccine management:22    
1. 	  training records, 
2. 	  documentation demonstrating the providers process to ensure that 
VFC vaccines are administered only to the VFC-eligible 
population, 
3.	   a routine storage and handling plan, 
4.	   an emergency storage and handling plan, 
5.	   a current provider enrollment form, 
6.	   a current provider profile form, and 
7.   temperature-monitoring logs.  
Meeting these requirements enables providers to (1) ensure that vaccines 
provide children with maximum protection against preventable diseases 
and (2) reduce the risk of fraud, waste, and abuse in the VFC program. 
The VFC Operations Guide also reflects FDAs vaccine storage 
requirements.23, 24  Specifically, vaccines must be stored within the 
required temperature ranges from the time they are shipped from the 
manufacturer until they are administered by the provider.25  For example, 
the varicella vaccine, which protects against the virus that causes 
 
21
 A dorm-style unit is a small combination refrigerator-freezer unit outfitted with a single external door.  Two 
types of storage units are acceptable for storing VFC vaccines:  (1) a refrigerator that has a separate freezer 
compartment with separate exterior door (combined unit) or (2) a stand-alone, single-purpose freezer or  
refrigerator  (stand-alone).  CDC,  VFC Operations Guide, Module 6:  Vaccine Management,  p. 7, 2011.   
Accessed at http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr
files.pdf on February 2, 2011.  
22
 CDC, VFC Operations Guide, Module 6:  Vaccine Management,  pp. 6-11, and Module 3:  Provider  
Recruitment and Enrollment, pp. 2-3, 2011.  Accessed at  
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.   Certain documents, such as temperature-monitoring logs,  must be maintained for at least 
3 years. 
23
 CDC, Vaccine Storage and Handling Guide, September 30, 2011.  Accessed at 
http://www.cdc.gov/vaccines/recs/storage/guide/vaccine-storage-handling.pdf on February 7, 2012.  
24
 CDC, VFC Operations Guide, Module 6: Vaccine Management, p. 3, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011. 
25
 Ibid., pp. 2-3. 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   4  
   
   
 
chickenpox, must be stored at or below 5 degrees Fahrenheit (F).26   
Exposure to a temperature above 5F reduces the vaccines ability to 
provide children with maximum  protection against chickenpox.   
Depending on the type of vaccine, providers must store vaccines in a 
central area of either a freezer or refrigerator.27  Cold air circulation is 
maximized when vaccines are stored in the center of a storage unit, where 
temperatures are also most stable.28  In other areas of freezers and 
refrigeratorssuch as spaces near walls, coils, floor, vents, and doors 
temperatures are not as stable as those in the center of the units.29   
Vaccines requiring refrigeration must be stored between 35F and 46F,  
and vaccines requiring freezer storage must be stored at or below 5F  .30    
Providers must monitor all vaccine storage temperatures using a certified,  
calibrated thermometer to ensure that vaccines are not exposed to 
temperatures outside the required ranges.31   Additionally, to obtain a 
temperature reading that is representative of the storage unit, a 
thermometer must be placed in a central area inside each freezer and 
refrigerator used to store VFC vaccines.32    
Providers must also monitor vaccine expiration dates and ensure that 
expired vaccines are not administered.33, 34  Providers must notify their 
respective grantees if vaccines expire and follow grantee guidance on how 
 
26
 FDA,  Varicella Vaccine Virus Package Insert (Varivax, Frozen), February 7, 2012.  Accessed at 
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142813.pdf on 
February 13, 2012.  
27
 CDC, VFC Operations Guide, Module 6: Vaccine Management, p. 9, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.    
28
 CDC, Vaccine Storage and Handling Toolkit, Appropriate Vaccine and Diluent Storage Conditions, pp. 2-3. 
  
Accessed at http://www2a.cdc.gov/vaccines/ed/shtoolkit/ on December 7, 2009. 
 
29

 Ibid.   
30
 CDC, VFC Operations Guide, Module 6: Vaccine Management, p. 3, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.   Storage temperature requirements are also listed in degrees Celsius (C).  Refrigerated 
vaccines must be stored between 2C and 8C (which convert to 35.6F and 46.4F, respectively) and vaccines  
requiring freezer storage must be stored at or below -15C (which converts to 5.0F). 
31 
Ibid., p. 4.  A variety of thermometer types may be used, including digital, minimum-maximum, standard  
fluid-filled, continuous recording, and dial thermometers.  CDC, Vaccine Storage and Handling Toolkit, 
Vaccine Storage Equipment, pp. 12-16.  Accessed at http://www2a.cdc.gov/vaccines/ed/shtoolkit/ on 
December 7, 2009.    
32 
CDC, Vaccine Storage and Handling Toolkit, Vaccine Storage Equipment, p. 16.  Accessed at  
 
http://www2a.cdc.gov/vaccines/ed/shtoolkit/ on December 7, 2009.   
33 
CDC, VFC Operations Guide, Module 6: Vaccine Management, pp. 9 and 11, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011. 
34
 CDC, Vaccine Storage and Handling Toolkit, Vaccine Personnel, p. 1.   Accessed at 
http://www2a.cdc.gov/vaccines/ed/shtoolkit/ on December 7, 2009.  
 
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to either return expired vaccines for excise tax credit or dispose of them.35   
Further, providers must remove the expired vaccines from freezers and 
refrigerators with nonexpired vaccines to prevent them from being 
mistakenly administered.36  Finally, providers must notify their respective 
grantees upon identifying vaccines that will expire before the providers 
can administer them.37  Grantees will determine the appropriate action to 
take to minimize vaccine waste.     
Grantee Oversight Requirements.  Grantees must meet the oversight 
requirements in CDCs VFC Operations Guide. For example, each 
grantee is responsible for developing and maintaining a vaccine 
accountability system that ensures that:38  
1.	   VFC vaccines are ordered on the basis of the size of each 

providers VFC-eligible population;  

2.	   VFC vaccines are administered only to VFC-eligible children; 
3. 	  VFC vaccine loss and waste are minimized and measured; and 
4.   the VFC program is protected against fraud and abuse. 
Grantees must develop a fraud and abuse policy that addresses 
(1) prevention and detection of fraud and abuse and (2) investigation and 
resolution of fraud and abuse allegations.  The policy must include the 
following eight activities and describe how they are integrated into the 
grantees daily VFC program administrative activities:39        
1.	   identifying oversight personnel, 
2.	   developing a fraud and abuse referral procedure,  
3.	   creating an allegation and referral database,  
4.	   developing a procedure for monitoring the program,  
5.	   developing training materials for personnel,  
 
35
 CDC, VFC Operations Guide, Module 6: Vaccine Management, pp. 6 and 11, 2011.  Accessed at 

http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on 
 
February 2, 2011. 
 
36
 Ibid., p. 11. 
 
37
 Ibid., p. 9. 
 
38
 CDC, VFC Operations Guide, Module 8: Vaccine Accountability, p. 1, 2011.  Accessed at 

http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on 
 
February 2, 2011. 

39
 CDC, VFC Operations Guide, Module 10: Fraud and Abuse, pp. 4-6, 2011.  Accessed at
  
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on 
 
February 2, 2011. 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   6  
   
   
 
6.   comparing enrolled providers to exclusion databases,40   
7.   developing a procedure for reporting provider terminations, and  
8.   creating a protocol to annually review fraud and abuse policies. 
When a provider enrolls in the program, its grantee conducts a one-time 
initial site visit to educate the providers staff about VFC program  
requirements and to ensure that the provider has appropriate equipment to 
implement the requirements.41  For example, the grantee should ensure 
that the provider has vaccine storage freezers and refrigerators that meet 
CDC requirements.42     
Grantees are also required to conduct periodic site visits of VFC providers.  
Since January 2011, grantees have been required to visit 50 percent of 
their providers each year.43  During these site visits, grantees interview 
providers and observe the storage of vaccines to complete the VFC Site 
Visit Questionnaire to evaluate whether providers meet program  
requirements for vaccine storage, management, and recordkeeping.44,  45   
Grantees must develop corrective action plans for providers whose 
answers to priority questions on the VFC Site Visit Questionnaire indicate 
that they are not complying with program requirements.  During 2010 site 
visits, grantees identified vaccine management deficiencies and developed 
corrective action plans for 57 percent of private providers and 46 percent 
of public providers.46  Providers may be suspended or terminated from the 
 
40
 CDC, VFC Operations Guide, Module 9: Quality Assurance, p. 3, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.   The Department of Health and Human Services (HHS)  Office of Inspector General (OIG) 
maintains a database of providers excluded from participating in federally  funded health care programs on the 
List of Excluded Individuals/Entities. Providers employing persons on this list may not participate in the VFC  
program. 
41
 CDC, VFC Operations Guide, Module 3:  Provider Recruitment and Enrollment, pp. 2 and 15, 2011.   
Accessed at http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr
files.pdf on February 2, 2011.  
42
 Ibid., p. 15.  Grantees should ensure that providers understand the vaccine management requirements in the  
VFC Operations Guide, including requirements regarding vaccine storage equipment.  
43
 CDC, VFC Operations Guide, Module 9: Quality Assurance, p. 2, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.   At least half of the VFC providers  should be visited in 1 year and the remaining half the 
following year.  Prior to January 2011, grantees were  required to conduct site visits of 25 percent of VFC 
providers per year, and there was no requirement specifying which providers were to be visited each year.  
44
 CDC created a VFC Provider Site Visit Questionnaireupdated periodicallythat grantees must use during 
their site visits.  Priority questions that providers do not meet automatically require corrective action. 
45
 CDC, VFC Operations Guide, Module 9: Quality Assurance, p. 2, 2011.  Accessed at 
http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf on  
February 2, 2011.   
46
 CDC, VFC/AFIX Activities Query Results, 2010. Accessed at 
http://www2a.cdc.gov/nip/irar/grantee/granteeinfo.asp#grptg on October 4, 2011.  Percentages are based on the 
total number of private and public providers with a site visit during 2010.  
 
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program if they do not meet requirements after implementing corrective 
action plans. 
VFC grantees must meet the vaccine management requirements in the 
VFC Operations Guide. For example, grantees must train VFC providers 
on appropriate vaccine ordering, handling, storage, and waste reporting.  
In addition, grantees must give providers an overall vaccine management  
plan template to ensure that providers meet CDCs vaccine management 
requirements.  Grantees are also required to ensure that vaccines remain 
effective by developing standard operating procedures for providers that 
address vaccine ordering, receiving, storage, handling, inventory 
management, and disposal.  Grantees  must also develop their own vaccine  
management policies and procedures based on CDCs VFC program  
requirements.  For example, grantees must establish their own policies 
regarding the types of thermometers that providers may use to monitor 
VFC freezer and refrigerator temperatures.     
METHODOLOGY 
Sample Selection 
The VFC program is implemented through 61 VFC grantees in 
collaboration with approximately 44,000 providers.  The scope of this 
evaluation did not allow for the review of vaccine management practices 
of all grantees and providers. Therefore, we selected a purposive sample 
of 45 providers within 5 grantee jurisdictions to conduct site visits and 
collect documentation.  We selected the five program grantees with the 
highest VFC vaccine order volumes during fiscal year (FY) 2010:  
California, Florida, Georgia, New York City, and Texas.47   These grantees 
ordered 36 percent of all VFC vaccines during FY 2010.  Appendix C lists 
the VFC vaccine order volume for each of the five selected grantees and 
the total VFC vaccine order volume for 2010.   
We visited nine VFC providers within each grantee jurisdiction.  To ensure 
diversity of providers, we selected providers according to three 
characteristics: provider type (i.e., private provider, public health 
department, FQHC/RHC, other type of public health clinic, or private 
hospital), vaccine  order volume (i.e., high or low), and location type  
 
47
 CDC, VFC vaccine dose data, provided by CDC on December 20, 2010.    
 
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(i.e., rural or urban).48, 49  Because we also met with grantee staff, we 
limited our sample of providers to those within 100 miles of each grantees 
office location.  Appendix D lists (1) the number of providers within the 
five selected grantee jurisdictions, (2) their three characteristics, and 
(3) the number of providers in our sample for each characteristic.   
Data Collection 
VFC provider site visits and interviews. We conducted site visits of the 
45 selected VFC providers to determine whether they met the 10 vaccine  
management requirements.  We notified providers of our site visits 
2 weeks in advance and conducted our site visits in April and May 2011.     
We conducted structured interviews using standardized data collection 
instruments.   We interviewed each providers VFC coordinator(s) on the 
providers procedures for vaccine management.  We also used a 
standardized data collection instrument to observe  VFC vaccine storage 
practices and review storage and temperature-monitoring equipment to 
determine whether providers met CDC requirements.  Finally, we checked 
vaccine expiration dates to determine whether VFC vaccines were expired 
on the days of our site visits. 
Independent temperature measurement. We independently measured 
temperatures of the vaccine storage equipment (i.e., freezers and 
refrigerators) for the 2-week period following our site visits (2-week 
period). We used a commercially available calibrated 
temperature-recording deviceTempTalethat met National Institute of  
Standards and Technology standards.50, 51   At each selected provider site, 
we placed one TempTale in a VFC vaccine freezer and one in a VFC 
vaccine refrigerator.  Each TempTale recorded temperatures every 
15 minutes for 2 weeks.52  For providers with more than one freezer and 
 
48
 Using CDCs Economic Order Quantity, we defined high-volume providers as those who receive at least  
800 vaccine doses per year and low-volume providers as those who receive 799 or fewer vaccine doses per 
year. 
49
 Urban areas were located within a core-based statistical  area (CBSA) and rural areas were not.  CBSAs  
include both metropolitan statistical areas (i.e., core urban areas with populations of 50,000 or  more) and 
micropolitan statistical areas (i.e., core urban areas with populations between 10,000 and 50,000).  U.S. Census 
Bureau, Metropolitan and Micropolitan Statistical Areas, accessed at  
http://www.census.gov/population/www/metroareas/metroarea.html on September 9, 2010.    
50  We purchased TempTale4 monitors (TempTale) and analytic services from a qualified contractor. The 
TempTale monitor temperature range is -22.0F to 158.0F and the accuracy  range is 2.0F from -22.0F to 
 
0F, 1.0F from 0F to 122.0F, and 2.0F from 122.0F to 158.0F. 
51
 The National Institutes of Standards and Technology is an agency of the U.S. Department of Commerce that  
develops measurement and accuracy standards and reference materials.  It also provides certification and 
calibration services to establish conformity and quality across devices. 
52
 Four selected providers did not have VFC vaccines in their freezers on the days of our site visits, so we did 
not place TempTales in their freezers.  We placed TempTales in a total of 86 freezers and refrigerators during 
our site visits.  
 
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one refrigerator storing VFC vaccines, we selected the freezer and 
refrigerator with the most VFC vaccines at the time of our visit.  To ensure 
that the TempTale was measuring the same temperature as the providers 
thermometer, we placed the TempTale next to the probe of the providers 
thermometer.  For providers with more than one thermometer per unit, we 
placed the TempTale next to the  thermometer closest to the center of the 
unit to ensure that the temperature we recorded was representative of the 
temperature in the unit.   
Provider documentation. One week prior to our site visits, we gave the 
selected providers a list of requested documents.  During site visits, we 
collected these documents, which included the providers policies and 
procedures for VFC vaccine storage and management, their overall 
vaccine management plans, and their routine and emergency storage and 
handling plans. We also collected training records, documentation used to 
ensure that VFC vaccines are administered only to VFC-eligible children 
(for example, sample eligibility screening forms or vaccine-use logs), 
provider enrollment and profile forms, and temperature-monitoring logs 
for 2010. We followed up with providers at least once to request 
documents that were not available during our site visits.  Providers also 
mailed us their temperature-monitoring logs for the 2-week period when 
we were independently measuring freezer and refrigerator temperatures.   
VFC grantee interviews and documentation. We interviewed the staff of  
each of the five VFC grantees to determine the extent to which the 
grantees met the VFC oversight requirements, including establishing 
accountability systems and developing comprehensive fraud and abuse 
policies. We conducted a structured interview with each grantee and 
collected documentationsuch as training materials, program guidance, 
and records of their provider site visitsto assess the grantees provider 
oversight activities.  We collected site visit records only for those 
providers with a grantee site visit in the 12 months preceding our site visit 
(i.e., between April 15, 2010, and April 15, 2011).  Additionally, because  
providers may submit their annual enrollment and profile forms to 
grantees electronically, we also requested these documents from the 
grantees.  
Data Analysis  
Vaccine storage temperatures. We analyzed freezer and refrigerator  
temperatures during the 2-week period to determine the extent to which 
VFC vaccines were exposed to temperatures outside the required ranges.  
Specifically, we used the TempTale data to determine how many freezers 
 
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and refrigerators were outside the required temperature ranges for at least 
5 cumulative hours during the 2-week period.  Temperatures recorded by 
TempTale devices were analyzed to the nearest tenth of a degree 
Fahrenheit. Any temperature higher than 5.0F was considered out of 
range for freezers, and any temperature lower than 35.6F or higher than 
46.4F was considered out of range for refrigerators. These ranges are 
based on exact Celsius-to-Fahrenheit conversions; however, in this report 
we have used the rounded temperatures (5F, 35F, and 46F) listed in 
both CDC and FDA guidance documents.   
We determined the longest span of consecutive hours each freezer and 
refrigerator was outside the required temperature range and the number 
and cost of vaccines in these units.  Cumulative and consecutive hours 
outside the required temperature ranges were based on number of minutes 
the TempTale recorded out-of-range temperatures.  We also determined 
the mean temperature of each freezer and refrigerator that was out of range 
for at least 5 hours during the 2-week period, as well as the standard 
deviation, temperature range, storage unit type, and thermometer type(s). 
We compared temperature data from each TempTale to the VFC 
providers temperature-monitoring logs for the 2-week period.  To do this, 
we used the temperature recorded by the TempTale at the time closest to 
each temperature recorded by the providers for the 2-week period.  For 
example, if a provider recorded a temperature at 9 a.m., we compared it to 
the TempTale measurement at the 15-minute interval closest to 9 a.m.   
Temperatures recorded by providers on monitoring logs were generally 
rounded to the nearest degree.  To maintain accuracy, we did not round our 
independently measured temperatures for our analysis; however, in this 
report we have rounded temperatures to the nearest degree.  We calculated 
the absolute value of the difference between the two temperatures and then 
calculated minimum, maximum, and mean differences for each provider 
and across all providers.53    
We also reviewed providers temperature-monitoring logs for 2010 to 
determine how often providers indicated that VFC vaccines were exposed 
to temperatures outside the required ranges for that year.  Each provider 
had approximately 960 opportunities to record out-of-range temperatures 
during 2010, based on the following assumptions:  (1) one freezer and one 
 
53
 Comparison does not apply for four providers without freezers storing VFC vaccines.  In addition, we were 
unable to compare all recorded freezer temperatures for 21 providers to independently  measured temperatures 
because of the temperature log formats.  For example, the minimum possible recorded freezer temperature was 
 3F on many providers temperature logs.  In these instances, we assumed the recorded temperature was 3F 
and calculated a difference only if the TempTale temperature for the same time was greater  than 3F.  
Comparison was not possible for seven providers freezers. 
 
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refrigerator per provider, (2) twice-daily temperature recordings for both 
the freezer and refrigerator, and (3) 20  days of temperature recordings per 
month for 12 months. 
Vaccine expiration. We determined the number of selected providers that 
had expired vaccines on the day of each site visit.  We calculated the total 
number and cost of expired vaccines.   We also determined how many days 
the expired vaccines were past expiration and whether they were separated 
from nonexpired vaccines.  Finally, we determined whether providers 
notify grantees upon identifying VFC vaccines that will expire before the 
providers can administer them.  
Vaccine management practices. We reviewed data from provider 
interviews and observations, as well as provider-supplied documentation, 
to determine which of the required activities in the 10 categories the 
providers had performed.  Providers had to perform all required activities 
within each category for us to conclude that they met the requirements for 
that category.  Additionally, if our observations during the site visits were  
not consistent either with providers documentation or with interview 
answers, we used our observations to determine whether the providers met 
the requirements.  For example, the Vaccine Storage Practices category 
includes a requirement for providers to rotate VFC vaccine stock by 
expiration date; for each vaccine type, providers must place vaccines with  
closer expiration dates in front of those with more distant expiration dates.  
If providers told us that they rotate vaccines as required but we observed 
vaccines that were not placed in order by expiration date, we determined 
that the providers did not meet the requirements in the Vaccine Storage 
Practices category.  
We also determined whether each selected provider had the seven vaccine  
management documents required by the VFC Operations Guide. These 
seven required documents are listed on page 4 of this report. 
Grantee oversight. We reviewed grantee interview responses and 
supporting documentation to determine the extent to which the five 
grantees met grantee vaccine accountability requirements established in 
the VFC Operations Guide.   These four oversight requirements are listed 
on page 6. 
We also determined the extent to which the selected grantees fraud and 
abuse policies addressed eight categories of activities required by the VFC 
Operations Guide. The list of these eight activities begins on page 6.       
 
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Grantees had to meet all of the fraud and abuse policy requirements within 
each category for us to conclude that they met the overall requirement for 
that category.   
In addition, we determined whether each of the five selected grantees 
provided required vaccine management materials to the nine VFC 
providers in their jurisdictions, including overall vaccine management 
plan templates and standard operating procedures.  We also compared our 
site visit results with the grantee site visit results for the 25 providers that 
had grantee site visits during the 12 months prior to our site visits 
(between April 15, 2010, and April 15, 2011).  We conducted this 
comparison to determine whether providers corrected grantee-identified 
deficiencies and continued to meet vaccine management requirements 
over time.  This analysis was based on our findings and grantees findings 
on 22 priority questions related to vaccine management.  These questions 
were included both on the grantee VFC Site Visit Questionnaire and in our 
data collection instruments.  
Limitations 
Our results apply only to our sample of 5 grantees and 45 providers and 
are not projectable to the population of 61 VFC grantees or approximately 
44,000 providers. 
TempTale measurements and differences between TempTale  
measurements and providers recorded temperatures were not adjusted to  
account for each devices accuracy range.  The accuracy range for 
TempTale devices is 2F from -22F to 0F and 1F from 0F to 
122F.  No standard accuracy range was established for the providers  
temperature-monitoring devices because of the wide variety of devices 
used by providers. 
Standards 
This study was conducted in accordance with the Quality Standards for 
Inspection and Evaluation issued by the Council of the Inspectors General 
on Integrity and Efficiency. 
 
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FINDINGS 
VFC vaccines stored by 76 percent of 45 providers we 
reviewed were exposed to inappropriate temperatures  
Although the majority of storage temperatures we independently measured 
during a 2-week period were within the required ranges, VFC vaccines 
stored by 76 percent34 of 45of the selected providers were exposed 
to inappropriate temperatures for at least 5 cumulative hours during that 
period.54  We also found that all 45 providers had recorded temperatures 
that differed from our independently measured temperatures during the 
2-week period. 
Sixteen of the thirty-four providers had both freezers and refrigerators that 
exposed VFC vaccines to temperatures outside the required ranges for 5 or 
more hours during the 2-week period.  If the 34 providers freezer and 
refrigerator temperatures followed this same pattern for a year, these 
storage units could expose vaccines to inappropriate temperatures for at 
least 130 hours over 1 year.55  On the days of our site visits, the 
34 providers had 9,173 VFC vaccine doses, worth approximately 
$368,820. See Appendix E for cumulative and consecutive hours during 
which these 34 providers freezers and refrigerators were outside the 
required ranges, as well as additional storage temperature information for 
the 2-week period. 
Freezer storage. VFC vaccines stored in 28 of 41 selected providers 
freezers were exposed to temperatures above the maximum permitted 
temperature (5F) for at least 5 cumulative hours during the 2-week 
period.56, 57  Eleven of these providers freezers were above 5F for more 
than 120 hours, representing at least 36 percent of the total 2-week period 
of our independent temperature measurement.  One providers freezer was 
above 5F for 94 percent of the total 2-week period, including a span of 
44 consecutive hours. Additionally, three providers freezers had a 
maximum temperature of at least 33F during the 2-week period, and one 
of these reached 44F. Exposure to temperatures above 5F may cause 
 
54
 Eighty-three percent and eighty-seven percent of  independently measured freezer and refrigerator 

temperatures, respectively,  were within the required temperature ranges during the 2-week period. 
 
55
 Assuming each freezer or refrigerator was outside the required range for at least 5 hours during all 26 2-week 

periods for 1 calendar year. 

56
 Four selected providers did not have VFC vaccines stored in freezers on the days of our site visits. 

57
 The accuracy range for TempTale devices placed in providers freezers is 2F from  -22F to 0F and 1F 

from 0F to 122F.   Eighty-nine percent of our independently  measured freezer temperatures were within 1F 

of the required range, and 93 percent of our independently measured freezer temperatures were within 2F.
  
 
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vaccines to lose their ability to provide maximum protection against 
preventable disease. The 28 providers stored 992 VFC vaccine doses in 
their freezers on the days of our site visits, worth approximately $67,660.    
Refrigerator storage. VFC vaccines stored in 22 of 45 selected providers 
refrigerators were exposed to temperatures outside the required range 
(above 46F, below 35F, or both) for at least 5 cumulative hours during 
the 2-week period.58  Four providers refrigerated vaccines were exposed 
to temperatures above 46F for at least 5 cumulative hours during the 
2-week period, and 19 providers refrigerated vaccines were exposed to 
temperatures below 35F for at least 5 hours.  One providers refrigerated 
VFC vaccines were exposed to temperatures both above 46F and below 
35F for at least 5 hours during the 2-week period.  The highest and lowest 
independently measured refrigerator temperatures among the 
22 refrigerators were 60F and 21F, respectively. Exposing vaccines to 
high or low temperatures can reduce their potency and efficacy, increasing 
the risk that the vaccine may not provide children with maximum  
protection against preventable diseases.  The 22 providers stored 
8,181 VFC vaccine doses in their refrigerators on the days of our site 
visits, worth approximately $301,160.   
Six providers refrigerated VFC vaccines were exposed to temperatures 
outside the required range for more than 120 hours, including one 
providers refrigerator that was above 46F for 265 hours (79 percent) of 
the total 2-week period.  Vaccines of eight providers whose refrigerated 
vaccines were exposed to temperatures outside the required range for at 
least 5 hours were exposed to freezing temperatures (i.e., temperatures at 
or below 32F) during the 2-week period, and one refrigerator storing 
VFC vaccines had an average temperature below 32F for the 2-week 
period. See Photo 1 for an example of a refrigerated vaccine exposed to 
freezing temperatures, as demonstrated by the ice on the exterior of the 
box (circled). 
 
58
 The accuracy range for TempTale devices placed in providers refrigerators is 1F from 0F to 122F.   
Ninety-two percent of our independently  measured refrigerator temperatures were within 1F of the required 
range.  
 
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Photo 1: Box of Refrigerated Influenza Vaccine Exposed to Freezing 
Temperatures (Note Ice in Circle) 
 
All 45 providers recorded temperatures that differed from our 
independently measured temperatures 
All 45 selected providers recorded temperatures that differed from our 
independently measured temperatures at least once during the 2-week 
period. These differences indicate that providers thermometers were not 
representing accurate temperatures or providers were not accurately 
recording the temperature readings.     
Twenty-five providers recorded at least 1 freezer temperature and 
24 providers recorded at least 1 refrigerator temperature that differed from  
our independent measurement by at least 5oF.  For example, one provider 
recorded a refrigerator temperature that differed from our independent 
measurement by 17F.  This provider recorded a temperature of 40F on 
the temperature-monitoring log, while the TempTale recorded a 
temperature of 23F for the same time period, well below the temperature 
necessary to inappropriately freeze the vaccines and reduce their potency  
and efficacy. On average, providers recorded freezer and refrigerator 
temperatures varied from our independently measured temperatures by 
4F and 2F, respectively.59      
 
59
 Comparison does not apply for four providers without freezers storing VFC vaccines.  In addition, we were 
unable to compare all recorded freezer temperatures for 21 providers to independently  measured temperatures 
because of the temperature log formats.  For example, the minimum possible recorded freezer temperature was 
 3F on many providers temperature logs.  In these instances, we assumed the recorded temperature was 3F 
and calculated a difference only if the TempTale temperature for the same time was greater  than 3F.  
Comparison was not possible for seven providers freezers.    
 
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In addition, only 12 of the 45 selected providers temperature-monitoring 
logs for 2010 included a temperature outside the required storage ranges.  
Further, less than 1 percent of these providers total temperature 
recordings were outside the required ranges.60  Three of the twelve 
providers did not document any actions taken as a result of temperatures 
being outside the required ranges.  The remaining nine providers 
documented actions such as notifying the appropriate vaccine 
manufacturer, notifying the grantee, adjusting the storage unit 
temperature, and moving the vaccines to another unit until the problem  
was resolved. If the same pattern of differences we found during the 
2week period between the TempTale-recorded temperatures and the 
provider-recorded temperatures existed throughout 2010, VFC vaccines 
were likely exposed to temperatures outside required ranges more 
frequently than providers documented.   
 
Sixteen of forty-five providers we reviewed had 
expired VFC vaccines 
According to FDA requirements, providers should not administer expired 
vaccines because they may not provide maximum protection against 
preventable diseases.61  Additionally, providers must remove expired 
vaccines from freezers and refrigerators containing nonexpired vaccines to 
prevent mistakenly administering expired vaccine.  Thirty-six percent 
(16 of 45) of selected providers had expired vaccines on the days of our 
site visits. Expired vaccines were an average of 186 days past their 
expiration dates on the days of our site visits, ranging from 6 to 673 days 
past expiration.  Thirteen providers stored expired vaccines with 
nonexpired vaccines, increasing the risk of mistakenly administering the 
expired vaccine. 
We identified 579 expired vaccine doses, worth $14,645, which represents 
3 percent of VFC vaccines we observed.62  If 3 percent of all VFC 
vaccines ordered during 2010 were allowed to expire, approximately     
2.4 million VFC vaccine doses would be subject to waste during the year.  
See Photo 2 for an example of an expired vaccine identified during one of 
our site visits. 
 
60
 The 12 providers recorded 74 instances of temperatures  outside required ranges out of a possible    
      
11,520 instances for 2010. 
  
61
 21 CFR  610.50, 610.53. 
   
62
 Seventy-three percent of identified expired vaccines were seasonal influenza vaccines.  Seasonal influenza 

vaccines expire at the end of each flu season.  Utilization of seasonal influenza vaccines varies from  year to 

year, depending on the severity of the flu season. 
   
 
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Photo 2: Varicella Vaccine, With an Expiration Date of 04 Dec 2010, 
Identified During Site Visit on 21 April 2011  
 
Providers must also monitor vaccine  expiration dates to identify vaccines 
that they do not expect to administer before expiration.  Providers should 
notify grantees of vaccines that will expire before the providers can 
administer them.  The grantees should then determine the appropriate 
action to take to prevent vaccine waste.  However, 7 of the 45 providers 
indicated that they do not notify grantees upon identifying vaccines that 
will expire before they can administer them.     
 
None of the 45 providers we reviewed met the vaccine 
management requirements in all 10 categories 
None of the forty-five selected VFC providers performed all required 
activities within each of the 10 vaccine management categories established 
in the VFC Operations Guide.   As a result, the 20,252 VFC vaccine doses 
that we observed during site visits may not provide children with 
maximum protection against preventable disease and may be vulnerable to 
fraud, waste, and abuse. These doses were worth approximately 
$800,000. In addition, 38 of 45 selected providers did not have all 
required VFC documentation.     
Forty of the forty-five selected providers did not meet all 
requirements in at least half of the vaccine management 
categories 
Forty selected providers did not meet all requirements in at least 5 of the 
10 requirement categories. The highest number of categories in which any 
provider met all requirements was 8 (1 provider), and 7 of the 45 selected 
 
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providers met all requirements in 2 or fewer categories.  Table 1 shows the 
number and percentage of providers that did not meet the requirements in  
each category.   See Appendix F to see in which of the 10 categories each 
provider did not meet all requirements. 
Table 1: Number and Percentage of Selected Providers That Did Not Meet All 
Requirements in Vaccine Management Categories  
Number of Providers  Percentage of Providers 
That Did Not Meet All  That Did Not Meet All 
Requirements in   Requirements in  
Category of Vaccine Management   Category   Category  
Requirements   (n=45)   (n=45)  
Vaccine Storage Equipment  43  96%  
Vaccine Storage Practices   42  93%  
Temperature Monitoring   40  89%  
Vaccine Storage and Handling Plans   38  84%  
Vaccine Personnel  37  82%  
Vaccine Waste   24  53%  
Vaccine Security and Equipment Maintenance  18  40%  
Vaccine Ordering and Inventory Management   17  38%  
Receiving Vaccine Shipments  14  31%  
Vaccine Preparation  1  2%  
 
    Source:  OIG analysis of  selected VFC provider documentation and site  visit observations, 2011. 
Of the 43 providers that did not meet all requirements in the Vaccine 
Storage Equipment category, 3 were permanently storing VFC vaccines in 
dorm-style storage units on the days of our site visits.63  VFC program  
requirements do not allow the use of dorm-style units for permanent VFC 
vaccine storage because such units are unable to reliably maintain 
temperatures within required ranges.  The average standard deviation of 
the temperatures recorded in dorm-style refrigerator units was 
approximately two times the average standard deviation for all refrigerator  
types.64  See Photo 3 for an example of the interior of a dorm-style storage 
unit that a VFC provider used for permanent VFC vaccine storage.  Note 
frost buildup on the bottom of the freezer compartment (circled).   
 
 
63
 The three providers were using a total of four dorm-style units to permanently store VFC vaccines.    
64
 The average temperature for dorm-style units during the 2-week period was 38F with a standard deviation 
of 4F.  In contrast, combined units had an average temperature of 39F with a standard deviation of 2F and 
stand-alone units averaged 40F with a standard deviation of 1F.  The overall standard deviation for all 
refrigerators we observed was 2F.  Sensitech analysis of TempTale data, 2011.  
 
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Photo 3: Dorm-Style Unit Used for Permanent VFC Vaccine Storage  
(Note Frost Buildup in Circle) 
 
 
Selected providers also did not meet thermometer requirements included 
in the Vaccine Storage Equipment category.  Specifically, thermometers 
were not always calibrated or centrally placed within the VFC vaccine 
storage units. For example, 38 providers had at least 1 thermometer that 
was not calibrated as required in their freezers and/or refrigerators.65  Our 
independently measured temperatures showed that VFC vaccines stored 
by 28 of these 38 providers were exposed to temperatures outside required 
ranges for at least 5 cumulative hours during the 2-week period.  In 
addition, 14 providers did not have at least 1 centrally placed thermometer 
in their respective freezers, and 23 providers did not have a centrally 
placed thermometer in their respective refrigerators.  Of these 14 and 
23 providers, our independently measured temperatures showed that 8 and 
11, respectively, stored vaccines outside the required temperature ranges 
for at least 5 hours.  Without calibrated, centrally placed thermometers, 
providers cannot ensure that their VFC freezers and refrigerators are 
maintaining temperatures within the required ranges.   
   
 
65
 We either did not observe a current (nonexpired) calibration sticker on the providers thermometers or the 
providers did not provide documentation demonstrating the thermometers were calibrated as required. 
 
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Thirty-eight of forty-five selected providers did not have all 

required documents 

Thirty-eight of forty-five selected VFC providers did not have at least one 
of seven required VFC program documents.  For example, providers must 
maintain records to demonstrate that relevant staff were trained on how to 
transport vaccines in an emergency.   Without this training, providers may 
not ensure that vaccines are maintained within the required temperature 
ranges during an emergency, such as a power outage.  Table 2 shows the 
number and percentage of providers that did not have each of the seven 
required documents.  See Appendix G for the required documents not 
provided by each of the 45 providers.  
    Table 2: Number and Percentage of Selected Providers Without Required 
Documents  
Number of Selected  Percentage  of  
VFC Providers  Selected VFC 
Without Document  Providers Without 
Required Document  
(n=45)   Document (n=45)  
VFC vaccine management training records   32  71%  
Documentation demonstrating the process to 
ensure that VFC vaccines are administered only to  
the VFC-eligible population  15  33%  
Routine storage and handling plan  
14  31%  
Emergency storage and handling plan 
12  27%  
Current provider enrollment form*  
8  18%  
Current provider profile form*  
8  18%  
Calendar year 2010 temperature-monitoring logs 
3  7%  
  * We also reviewed grantee documentation  to  determine whether providers had current enrollment and profile forms.  
If a grantee had the  document, we considered the provider to have the document for these analyses.  
 
    Source:  OIG analysis of  selected VFC provider documentation, 2011. 
None of the five VFC grantees we reviewed met all 
oversight requirements, and grantee site visits were 
not effective in ensuring that providers met VFC 
requirements over time 
None of the five selected VFC grantees met all of the oversight 

requirements we reviewed, including accountability requirements, 

establishing comprehensive fraud and abuse policies, and providing 

required vaccine management materials to VFC providers.  In addition, 

 
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grantee site visits did not ensure that providers met vaccine management 
requirements over time. 
Two of the five selected VFC grantees did not meet two 
accountability requirements 
Two selected VFC grantees each did not meet two of the four vaccine 
accountability requirements established in the VFC Operations Guide. 
The three remaining grantees met all four vaccine accountability 
requirements.  One of the two grantees that did not meet all four 
accountability requirements did not ensure that vaccines purchased with 
VFC funds were administered only to VFC-eligible children or that 
vaccines were ordered on the basis of  the size of a providers VFC-eligible 
population. The other grantee did not ensure that vaccine loss and waste 
were minimized and measured or that the VFC program was protected 
against fraud and abuse.  Grantees that do not implement these four 
requirements may have an increased risk of fraud, waste, and abuse in 
their VFC programs.   
None of the selected grantees fraud and abuse policies 
addressed all required activities 
None of the selected grantees fraud and abuse policies addressed all eight 
activities needed to establish a comprehensive fraud and abuse mitigation 
plan. According to the VFC Operations Guide, all grantees should have 
well-defined processes for (1) the prevention and identification of fraud 
and abuse and (2) the investigation and resolution of suspected cases of 
fraud and abuse within their VFC programs.  None of the selected grantees  
fraud and abuse policies addressed the following two activities:   
(1) comparing enrolled providers to exclusion databases and 
(2) developing a procedure for reporting provider terminations.  In 
addition, four of the five selected grantees fraud and abuse policies did 
not include a fraud and abuse referral procedure.  Also, four of five 
grantees did not establish an allegation and referral database in their 
policies. Table 3 shows the number and percentage of selected grantees 
whose fraud and abuse policies did not include each of the eight required 
activities.  See Appendix H for the activities not included in each selected 
grantees fraud and abuse policy.  
 
   
 
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Table 3: Number and Percentage of Selected Grantees Whose Fraud and Abuse 
Policies Did Not Include Each Required Activity  
Number of Grantees  Percentage  of  
Fraud and Abuse  Grantees Fraud  and 
Policies Without  Abuse Policies   
Required Activity   Without Required 
Required Activity   (n=5)   Activity (n=5) 
Comparing enrolled providers to exclusion databases 
5  100%  
Developing a procedure for reporting VFC provider terminations 
5  100%  
Developing a fraud and abuse referral procedure  
4  80%  
Creating an allegation and referral database  
4  80%  
Identifying oversight personnel  
3  60%  
Creating a protocol to annually review fraud and abuse policies 
3  60%  
Developing a procedure for monitoring the VFC Program  
2  40%  
Developing training materials for VFC personnel 
2  40%  
Source:  OIG analysis of  selected grantees fraud and abuse policies, 2011. 
None of the selected grantees provided required vaccine 
management materials to all providers 
None of the five selected grantees provided required vaccine management  
materials to all nine selected VFC providers in their respective 
jurisdictions.  These materials are intended to assist VFC providers in 
meeting the vaccine management requirements in the VFC Operations 
Guide. Grantees must give providers a standardized vaccine management  
plan template, which providers may use to meet the routine and 
emergency storage and handling plan requirements.  Fourteen selected 
providers did not have overall vaccine management plans.   
In addition, grantees did not provide standard operating procedures to all 
providers, as required. At least seven of the nine selected providers in 
each grantee jurisdiction did not provide at least one of the eight written 
procedures that we requested during our site visits.   
Finally, one grantee provided inaccurate guidance to VFC providers in its 
jurisdiction. This grantee provided a temperature-monitoring log template 
that instructed providers to maintain the logs for 1 year; however, the VFC 
Operations Guide requires these logs to be maintained for a minimum of 
3 years. 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   23  
   
   
 
Site visits by the selected grantees did not ensure that 
providers met vaccine management requirements over time 
Twenty-five of the forty-five selected VFC providers had a grantee site 
visit during the 12 months prior to our site visits.  However, the results of 
our site visits for these 25 providers differed from those of the grantees.  
We determined during our site visits that, on average, these 25 providers 
did not meet 6 vaccine management requirements, whereas grantees 
determined that providers did not meet an average of 2 requirements.  
Overall, we found that 21 of the 25 providers met fewer vaccine 
management requirements during our site visits than during grantee site 
visits conducted within the previous 12 months.  For example, 2 of these 
25 providers were using dorm-style units to store their VFC vaccines 
when we conducted our site visits.  However, the grantees site visits 
including one grantee site visit conducted less than 2 months before our 
site visitdid not identify these dorm-style units.  In addition, five 
providers did not have routine or emergency handling plans on the days of 
our site visits. However, the grantee site visit reports noted that these 
providers did have such plans.66  We could not determine whether the 
grantee site visit results were not accurate or whether providers had been 
in compliance with vaccine storage requirements at the time of the grantee 
site visits and later stopped following program requirements.  In either 
case, site visits were not effective in ensuring that providers met vaccine 
management requirements over time.       
 
   
 
66
 The time interval between grantees site visits for these five providers and  our site visits ranged from 5 days  
to 344 days.  
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   24  
   
   
 
CONCLUSION AND RECOMMENDATIONS 
Although the majority of storage temperatures we independently measured 
during a 2-week period were within the required ranges, VFC vaccines 
stored by 76 percent34 of 45of the selected providers were exposed 
to inappropriate temperatures for at least 5 cumulative hours during that 
period. If these 34 providers freezer and refrigerator temperatures 
followed this same pattern for a year, these storage units could expose 
vaccines to inappropriate temperatures for at least 130 hours over 1 year.  
The 34 providers had 9,173 VFC vaccine doses on the days of our site 
visits, worth approximately $368,820.   
Additionally, 16 of 45 selected providers had expired VFC vaccines. 
Thirteen of these providers did not remove their expired vaccines from  
freezers or refrigerators containing nonexpired vaccines, increasing the 
risk that the expired vaccines could be mistakenly administered.  Expired 
vaccines accounted for 3 percent of all VFC vaccines observed on the days  
of our site visits.  If 3 percent of all VFC vaccines ordered during 2010 
were allowed to expire, approximately 2.4 million VFC vaccine doses 
would be subject to waste during the year.     
None of the 45 selected providers that we reviewed managed VFC 
vaccines according to all vaccine management requirements, and 
38 providers did not have all required documents.  In addition, none of the 
five VFC grantees that we reviewed met all oversight requirements or 
provided required vaccine management materials to all selected VFC 
providers in their jurisdictions. Finally, grantees site visits to 25 selected 
providers did not ensure that these providers met vaccine management 
requirements over time. 
To address our findings, we recommend that CDC continue to work with 
grantees and providers to: 
Ensure That VFC Vaccines Are Stored According to 
Requirements 
The VFC Operations Guide requires grantees to ensure that VFC 
providers have appropriate equipment to meet the vaccine management 
requirements during enrollment site visits.  CDC should continue to work 
with grantees, providers, and professional organizations to ensure that 
VFC vaccines are stored and temperatures are monitored according to 
program and FDA requirements.  Specifically, grantees should ensure that 
providers have freezers and refrigerators that can maintain vaccines within  
   
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   25  
   
   
 
the required temperature ranges, as well as accurate 
temperaturemonitoring devices that are regularly calibrated and centrally 
placed within freezers and refrigerators.  Providers without appropriate 
equipment, such as those with dorm-style storage units or noncalibrated 
thermometers, should not receive VFC vaccines.   
Ensure That Expired VFC Vaccines Are Identified and 
Separated From Nonexpired Vaccines 
CDC and grantees should continue to work with providers and 
professional organizations to ensure that VFC providers monitor vaccine  
expiration dates to identify expired vaccines.  In addition, providers should 
immediately remove expired vaccines from freezers and refrigerators used 
to store nonexpired vaccines to prevent inadvertent administration of 
expired vaccines. If expired vaccines are mistakenly administered, they 
may not provide children with maximum protection against preventable 
disease. To reduce the likelihood of administering expired vaccines, 
grantees should ensure that providers immediately report expired vaccines 
and ensure that providers follow the grantees guidance on the disposal of 
expired vaccines.  Where possible, grantees should ensure that providers 
return expired VFC vaccines for excise tax credit.   
Ensure That Grantees Better Manage Providers Vaccine 
Inventories 
CDC and grantees should improve vaccine inventory management systems 
and procedures to ensure that providers vaccine orders reflect their needs 
and reduce vaccine waste.  Before approving vaccine orders, grantees 
should review providers profile forms; their inventories of current 
vaccine, including expiration dates; and their doses-administered reports.  
Further, grantees should ensure that providers notify them upon 
identifying vaccines that will expire before the providers can use them.  
To prevent program waste, grantees should consider alternate approaches, 
such as increasing the use of these vaccines through vaccination drives.  
Improved inventory systems and procedures for vaccine management can 
prevent provider stockpiling and excessive inventories of all VFC 
vaccines, including seasonal flu vaccines.  
Ensure That Grantees Meet Oversight Requirements 
CDC should review grantees activities and materials to ensure that they 
meet oversight requirements.  Before distributing vaccines to providers,  
CDC should review grantees policies for ensuring accountability and 
preventing fraud and abuse, as well as the training materials, the written 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   26  
   
   
 
procedures, and document templates they have developed for providers.  
CDC should ensure that grantees templates and training materials focus 
on: (1) the vaccine management requirements that selected providers met 
least frequently and that have the greatest impact on vaccine potency and 
efficacy and (2) VFC program accountability requirements.  Finally, CDC 
should review the reports from grantees annual site visits to identify 
grantees specific needs for provider training.  CDC should periodically 
train grantees site visit staffs to ensure that grantee site visits to providers 
result in improved vaccine management and program accountability. 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   27  
   
   
 
AGENCY COMMENTS AND OFFICE OF INSPECTOR GENERAL  
RESPONSE 
CDC concurred with all four of our recommendations and noted that 
vaccination is one of the most successful public health tools in preventing  
and controlling disease. According to CDC, the United States has 
achieved 90-percent or greater reduction in most vaccine-preventable 
diseases through public and private vaccination efforts.  Further, CDC 
noted that VFC providers generally manage their public and private stock 
vaccines in a similar manner and 90 percent of U.S. children are 
vaccinated by a provider that participates in the VFC program.  Therefore, 
CDC believes that its efforts to strengthen VFC program storage and 
handling practices will help improve vaccination services nationally and 
benefit children vaccinated with both publicly and privately purchased 
vaccines.  
With regard to our first recommendation, CDC stated that it will work 
with its partners, including State health officials, immunization program  
managers, and professional organizations, to improve compliance with 
vaccine storage equipment and temperature-monitoring requirements to 
ensure proper vaccine storage.  
With regard to the second and third recommendations, CDC said that it is 
implementing significant changes to the VFC vaccine ordering and 
provider inventory reporting systems.  Improvements to these systems and 
associated processes will result in better vaccine management, reducing 
the risk of expired vaccines.  CDC will also review its guidance and 
training materials to ensure that program requirements related to managing 
expired vaccines are communicated to and understood by VFC providers 
and grantees. 
With regard to our fourth recommendation, CDC stated that it will work 
with VFC grantees and provider organizations to ensure that program  
requirements are necessary for effective program oversight.  In addition, 
CDC will task working groups with reviewing VFC provider site visit 
procedures and documentation to ensure that site visits are effective in 
enforcing program requirements. 
We support CDCs efforts to address these issues and encourage it to 
continue making progress.  For the full text of CDCs comments, see 
Appendix I. 
 
 
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APPENDIX A 

Vaccines for Children Program Vaccines and Required Storage Temperatures  
Vaccines That Must Be Stored Between 35F and 46F  
Vaccine  Brand  Manufacturer 
Diphtheria and Tetanus Toxoids and Acellular  Daptacel 
Pertussis Vaccine Adsorbed (DtaP)  Tripedia   Sanofi Pasteur, Inc. 
Infanrix  GlaxoSmithKline Biologicals  
Diphtheria and Tetanus Toxoids and Acellular 
Pertussis Vaccine Adsorbed, Hepatitis B 
(recombinant) and Inactivated Poliovirus Vaccine 
Combined (DtaP-Hep B- IPV)  Pediarix   GlaxoSmithKline Biologicals  
Diphtheria and Tetanus Toxoids and Acellular 
Pertussis Adsorbed and Inactivated Poliovirus  
Vaccine (DtaP-IPV)  KINRIX  GlaxoSmithKline Biologicals  
Diphtheria and Tetanus Toxoids and Acellular 
Pertussis Adsorbed, Inactivated Poliovirus and 
Haemophilus  b Conjugate (Tetanus Toxoid  
Conjugate) Vaccine (DtaP-IP-HI)  Pentacel   Sanofi Pasteur, Inc. 
Haemophilus  b Conjugate (Meningococcal Protein 
Conjugate) (Recombinant) (Hepatitis B-Hib)   Comvax  Merck & Co., Inc. 
Haemophilus  b Conjugate (Meningococcal Protein 
Conjugate) (Hib)   PedvaxHIB  Merck & Co., Inc. 
Haemophilus  b Conjugate Vaccine (Tetanus  Toxoid  
ActHIB  Sanofi Pasteur, Inc. 
Conjugate) (Hib) 
Hiberix  GlaxoSmithKline Biologicals  
Hepatitis A Vaccine, Inactivated 
VAQTA   Merck & Co., Inc. 
Havrix  GlaxoSmithKline Biologicals  
Hepatitis A Inactivated and Hepatitis B 
(Recombinant) Vaccine (Hepatitis A - Hepatitis B)  Twinrix  GlaxoSmithKline Biologicals  
Hepatitis B Vaccine (Recombinant) 
Engerix-B  GlaxoSmithKline Biologicals  
Recombivax HB  Merck & Co., Inc. 
Human Papillomavirus Bivalent (Types 16, 18) 
Vaccine, Recombinant (HPV)   Cervarix   GlaxoSmithKline Biologicals  
Human Papillomavirus Quadrivalent (Types 6, 11, 
16, 18) Vaccine, Recombinant (HPV)  Gardasil  Merck & Co., Inc. 
Influenza Vaccine, Live, Intranasal   FluMist  MedImmune, LLC. 
Influenza Virus Vaccine, Trivalent, Types A and B   Novartis Vaccines and Diagnostics 
Fluvirin  Ltd. 
Fluzone   Sanofi Pasteur, Inc. 
Measles, Mumps, and Rubella Virus Vaccine, Live 
(MMR)  M-M-R II  Merck & Co., Inc. 
Meningococcal Polysaccharide (Serogroups A, C, Y, 
and W-135) Diphtheria Toxoid Conjugate Vaccine   Menactra   Sanofi Pasteur, Inc. 
Meningococcal (Groups A, C, Y, and W-135) 
Oligosaccharide Diphtheria CRM197 Conjugate  Novartis Vaccines and Diagnostics, 
Vaccine  Menveo  Inc. 
continued on next page  
 
 
 
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Appendix A, continued 
 
 
Vaccines for Children Program Vaccines and Required Storage Temperatures  
Vaccines That Must Be Stored Between 35F and 46F  
Vaccine  Brand  Manufacturer 
Pneumococcal 13-valent Conjugate Vaccine  
(Diphtheria CRM  Protein) (PCV)  Prevnar 13   Wyeth Pharmaceuticals Inc. 
197
Pneumococcal Vaccine, Polyvalent 
Pneumovax 23   Merck & Co, Inc 
Poliovirus Vaccine Inactivated (Monkey Kidney Cell) 
(e-IPV)  IPOL  Sanofi Pasteur, SA 
Rotavirus Vaccine, Live, Oral 
ROTARIX  GlaxoSmithKline Biologicals  
Rotavirus Vaccine, Live, Oral, Pentavalent 
RotaTeq  Merck & Co., Inc. 
Tetanus and Diphtheria Toxoids 
Decavac   Sanofi Pasteur, SA 
MassBiologics  MassBiologics  
Tetanus Toxoid, Reduced Diphtheria Toxoid and 
Adacel   Sanofi Pasteur, Inc. 
Acellular Pertussis Vaccine, Adsorbed (Tdap) 
Boostrix  GlaxoSmithKline Biologicals  
Vaccines That Must Be Stored at or Below  5F  
Measles, Mumps, Rubella, and Varicella Virus 
Vaccine Live (MMR-V)*  ProQuad  Merck & Co., Inc. 
Varicella Virus Vaccine Live* 
Varivax  Merck & Co., Inc. 
* These vaccines are also available in refrigerator-stable versions that can be  stored in either a freezer or a refrigerator.  Refrigerator-stable 
MMR-V and Varicella vaccines that  are first stored in a freezer and subsequently stored in a refrigerator  should not be refrozen and must be  
used within 72 hours. 
Sources: FDA, Vaccines licensed for immunization and distribution in the US with supporting  documents.  Accessed  at 
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093830.htm  on November 29, 2010.  
CDC,  CDC vaccine price list.   Accessed at http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm on November 29, 2010.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   30  
   
   
 
APPENDIX B 

 
Vaccines for Children Program Vaccine Management Requirements for Providers  
Requirement 
Category    Required Activities 
Providers must have appropriate equipment that can store vaccine and maintain proper conditions.  
For detailed information on refrigerators and freezers, grantees and providers should refer to [the 
Centers for Disease Control and Preventions (CDC)] Vaccine Storage and Handling Toolkit. Two 
types of storage units are acceptable:  1) a refrigerator that has a separate freezer compartment with 
separate exterior door, or 2) stand-alone, single-purpose refrigerators and freezers.  
Refrigerators or freezers used for vaccine storage must be able to maintain required vaccine storage 
temperatures year-round.  
Refrigerators or freezers used for vaccine storage must be large enough to hold the years largest 
inventory.  
Refrigerators or freezers used for vaccine storage must have a working thermometer calibrated with 
certificate in accordance with National Institute of Standards and Technology (NIST) or the American  
Society for Testing and Materials (ASTM) standards placed in a central area inside each storage 
compartment; follow manufacturers recommended schedule for recalibration.  
Refrigerators or freezers used for vaccine storage must be dedicated to the storage of vaccines.  
(Food and beverages must not be stored in a vaccine  storage unit because this practice results in 
frequent opening of the door and destabilization of the temperature.) 
A dormitory-style refrigerator (a small combination refrigerator-freezer unit outfitted with a single 
external door) is never acceptable for permanent storage of Vaccines for Children (VFC) vaccines 
.... At the grantees discretion, providers may use dormitory-style refrigerators to temporarily  store a 
Vaccine Storage 
clinics single-day supply  of refrigerated vaccines.  The freezer portion of a dormitory-style refrigerator 
Equipment  
must never be used to store any vaccine ....   
Grantees have the discretion to ban the use of dormitory-style refrigerators among providers 
altogether, even for temporary storage.  However, for grantees choosing to allow the use of  
dormitory-style refrigerators under limited conditions for short-term (temporary) storage of VFC 
vaccines, the following conditions must apply: 
1. The purpose of using these units is for temporary storage when it is not reasonable for the staff 
administering the vaccine to go to the main storage unit to obtain vaccine for each and every patient. 
2. The unit is  never used for storing varicella-containing  vaccines.  
3. Only small amounts of inactivated vaccines  are maintained in these units.  The amount of 
inactivated vaccines stored in the unit must never exceed the amount used in the clinic in one day.  
4. The vaccine is returned to the main storage unit at the end of each clinic business day, and vaccine 
is never stored in these units overnight or during periods of time when the practice is not open for 
business.  
5. Each unit has a dedicated calibrated thermometer in place. 
6. Temperatures are visually monitored and documented twice a day on a temperature log  
specifically for that unit.  Appropriate action is immediately taken when the temperatures are outside  
the appropriate range.   
7. These units must be included and examined during the VFC compliance site visit and corrective 
actions taken and documented by the grantee if any  of the above conditions are not met. 
The vaccine storage practices ... are the responsibility  of the provider/clinic vaccine coordinator or the 
vaccine coordinators backup.  If delegated to the backup, the designated vaccine coordinator must 
monitor these activities regularly.  
Rotate vaccine stock by placing vaccines with shorter expiration dates in front of those with longer 
Vaccine Storage  expiration dates; check for short-dated vaccine.  
Practices   Notify the immunization program of any vaccine doses that will expire before they can be  
administered.  
Only  with the approval and direct guidance of the immunization program and only if the cold chain can 
be ensured, redistribute short-dated vaccines to high-volume providers who are able to administer it 
before it expires. 
Continued on next page  
 
 
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Appendix B, continued 
                               
 
Vaccines for Children Program Vaccine Management Requirements for Providers  
Requirement 
Category  Required Activities 
Store vaccines that require refrigeration in the middle of the refrigerator compartment away from the coils, 
walls, floor, and cold air vent. 
Store vaccines that require freezer storage in the middle of the freezer compartment, away from the walls, 
coils, and peripheral areas.  
Vaccine Storage 
Practices (contd)  
Space stored vaccine to allow for cold air circulation around the vaccine. 
Never store vaccines in the door of the storage unit. 
Never store food or drink in the storage unit. 
Temperature monitoring should be the primary responsibility of the provider/clinic vaccine coordinator and 
back-up. If other staff must monitor temperatures, those persons must be trained on how  to respond to 
and document actions taken when temperatures are outside the appropriate range.  
Post a temperature log on the vaccine storage unit door or nearby in a readily  accessible and visible 
location.  
Record refrigerator and freezer temperatures twice each day (beginning and end) ensuring that refrigerator 
Temperature  temperatures are between 35F and 46F. The freezer temperature should be 5F or lower.   Twice-daily 
Monitoring   temperature monitoring and recording is required even if a continuous graphing/recording thermometer or 
a digital data logger is used.  
Take immediate action to correct improper vaccine storage conditions, including inappropriate exposure to 
light and inappropriate exposure to storage temperatures outside the recommended ranges.  Document 
actions taken on the temperature log. 
Maintain an ongoing file of temperature logs, and store completed logs for at least 3 years. 
Providers must have written routine and emergency storage and handling plans.  They may develop their 
own or customize the grantee-supplied storage and handling templates to reflect their office practice .... 
Both plans should be reviewed and updated as necessary.  
The routine vaccine storage and handling plan should include guidance on routine vaccine management 
process/practices.  Please refer to Routine Vaccine Storage and Handling Plan Worksheet in the Vaccine 
Storage and Handling Toolkit. 
The emergency vaccine storage and handling plan must include guidance on what to do in the event of 
refrigerator or freezer malfunctions, power failures, natural disasters, or other emergencies that might 
Vaccine Storage 
compromise appropriate vaccine storage conditions.  Please refer to Emergency Vaccine Retrieval and  
and Handling 
Storage Plan Worksheet found in the Vaccine Storage and Handling Toolkit. 
Plans 
In any type of power outage:  
- Freezers and refrigerators should not be opened until power is restored, except to transport 
vaccine to an alternative storage location. 
- Temperatures and duration of power outage must be monitored; vaccine should not be discarded  
or administered until the situation has been  discussed with public health authorities. 
At a minimum, the emergency plan must be reviewed  and updated annually (or as necessary) or when  
there is a change in staff that have responsibilities specified in the emergency plan.  
Continued on next page  
   
 
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Appendix B, continued 
                               
 
Vaccines for Children Program Vaccine Management Requirements for Providers  
Requirement 
Category  Required Activities 
Designate one staff member to be the primary vaccine coordinator and at least one backup vaccine  
coordinator who is able to perform the same responsibilities as the primary vaccine coordinator in the 
event that the primary person is unavailable.  These positions will be responsible for key requirements and 
will provide oversight for all vaccine management within the office. 
The designated vaccine coordinator and backup must be responsible for reviewing vaccine storage unit 
temperatures to ensure they  are within the recommended ranges and documenting the temperature on the 
Vaccine  
temperature logs for each storage unit twice a day.  
Personnel 
Train other staff who are responsible for administering vaccines or who may  be required to transport 
vaccine in an emergency situation, following the offices vaccine storage and handling plan.  A simple log 
sheet with the staff members name and date of training must be kept and displayed as documentation.  
Unless otherwise noted, the vaccine coordinator and/or backup should be the VFC contacts for the office. 
Notify immediately the immunization program of vaccine cold chain failure/wastage incidents involving 
publicly funded vaccines after discovery  of the incident.  Follow the guidance of the grantee on how to  
document and report the incident .... 
Implement written protocols for reporting and responding to losses resulting from vaccine expiration, 
Vaccine Waste  wastage, and compromised cold chain.  
Remove  wasted/expired vaccine from storage containers with viable vaccine to prevent inadvertent 
administration. 
Return, as directed by the grantee, all spoiled or expired publicly purchased vaccines for excise tax credit. 
Vaccine Security  
Post DO NOT  DISCONNECT notices at both the electrical outlet and the circuit breaker to prevent power 
and Equipment 
from being disconnected.  
Maintenance 
Order vaccine in accordance with actual vaccine need. 
Vaccine Ordering  
Develop and maintain complete, accurate, and separate stock records for both publicly and privately 
and Inventory  
purchased vaccines.  The requirement to keep separate records does not necessitate having separate 
Management 
storage units for public and private vaccines.  Providers must be able to distinguish between their public  
and private vaccine stock.  
VFC vaccine shipments received from the distributor contain heat and freeze exposure indicators.  VFC 
direct shipments of frozen vaccine from manufacturers are shipped in specialized boxes and do not contain 
heat indicators.  
Receiving 
Immediately  upon delivery of vaccine, check the vaccine cold chain monitors, if included, and store vaccine 
Vaccine  
according to manufacturers product specifications.    
Shipments 
Take proper action if either the freeze or heat cold chain monitor was activated.  Instructions for reading  
the monitors are printed on the monitor cards. 
Continued on next page  
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   33  
   
   
 
 
 
 
 
Appendix B, continued 
 
Vaccines for Children Program Vaccine Management Requirements for Providers  
Requirement 
Category     Required Activities 
Document heat or freeze monitor readings if indicative of out-of-range temperature exposure, and contact 
the State immunization program for further guidance.  Document actions taken based on State 
immunization program instructions.  
Receiving 
Vaccine   If the provider believes that a vaccine shipment is compromised, temperature monitors are out of range, or 
Shipments  a heat monitor is not activated (i.e., turned on), the provider should also contact McKesson Customer 
(contd)   Service within 2 hours of vaccine shipment delivery time.  
Develop policies and protocols for maintaining the vaccine cold chain during transport to offsite clinics or 
emergency storage locations.  
The National Center for Immunization and Respiratory  Diseases (NCIRD), Centers for Disease Control and 
Vaccine   Prevention, strongly recommends that providers draw vaccine only at the time of administration to ensure 
Preparation   that the cold chain is maintained and that vaccine is not inappropriately  exposed to light.  Do not pre-draw  
doses before they are needed. 
 Source:  CDC,  VFC Operations  Guide, Module 6:  Vaccine Management, pp. 1-12, January 2011. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   34  
   
   
 
APPENDIX C 

 
 
 
 
Five Vaccines for Children Program Grantees With Highest Vaccine Order Volumes  
 
Vaccine Doses  Percentage  of Total Vaccine 
Grantee  Ordered  Doses Ordered  
California   9,466,260  12%  
Texas   8,749,080  11%  
Florida  4,301,029  5%  
New York City  3,412,996  4%  
Georgia   3,244,547  4%  
Total Vaccine Doses Ordered for Top   
Five Grantees   29,173,912  36% 
Total Vaccine Doses Ordered for All 
Grantees   81,632,576  100%  
Source:  Data provided by Centers for  Disease Control and Prevention officials, December 20, 2010, and January 14, 2011.  Data  
reflect volume of vaccine orders for fiscal year 2010. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   35  
   
   
 
APPENDIX D 

 
 
Vaccines for Children Program Providers in the Five Selected Grantee Jurisdictions by  Sample Selection 
Characteristics  
   
 Number of Vaccines for  Percentage of VFC 
Children (VFC)  Providers in  Number of VFC  Percentage of 
Providers in Population  Population for   Providers in  VFC Providers 
Characteristic  for Selected Grantees   Selected Grantees   Sample  in Sample 
Provider Type 
Private Practice   8,235   74%   33   73%  
Public Health Department   928   8%   4  9%  
Federally Qualified Health 
Center or Rural Health Clinic   823   7%   3  7%  
Other Public Health Provider  785   7%   3  7%  
Private Hospital   313   3%   2  4%  
Grantees' Total Providers 
by Selected Provider 
Types1   11,084   99%2   45   100%  
 
Vaccine Order Volume  
Low Volume   5,128   42%                   19  42%  
High Volume    7,171   58%   26   58%  
Grantees' Total Providers  
by Volumes  12,299   100%                   45  100%  
 
Location Type 
Rural  336   9%   5  11%  
Urban  3,266   91%   40   89%  
Grantees' Total Providers  
by Location Types3   3,602   100%   45   100%  
Source:  Data provided by Centers for  Disease Control and Prevention officials, December 20-29, 2010. 
1 Total providers by type differs from total providers by volume because we limited our sample  to these five provider types.  The remaining 1,215 providers were 
types not included in our sample. 
2 Figures do not  sum to 100 because of rounding. 
3 Only providers within 100 miles of  the grantees VFC  program office locations were included in  our sample. 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   36  
   
   
 
APPENDIX E 
 
Selected Vaccines for Children Program Providers With Storage Units Outside the Required Temperature Range During a 2-Week 
Period 
Table E-1:  Twenty-eight Freezers Above 5F for at Least 5 Cumulative Hours  
Cumulative Hours  Longest Consecutive  Mean Temperature  Standard Deviation   Temperature Range 
Above Required    Hours Above   During Entire  During Entire  During Entire 2-Week 
Provider   Range   Required Range   2-Week Period (F)   2-Week Period (F)  Period (F)   Thermometer Type(s)   Unit Type  
Digital, Min-Max
28  316.5   43.8  8.1  4.3  4.6  28.3    Standard Fluid  Combined  
27  202.0   23.3  5.6  1.6  1.9  16.2   Standard Fluid  Combined  
10  195.3   3.0  5.7  2.7  -2.1  15.1   Standard Fluid  Combined  
Digital 
36  162.0   2.3  5.6  2.8  2.7  22.3   Digital, Min-Max  Combined  
Dial 
20  138.5   20.0  3.4  6.5  -11.4  44.3   Digital, Min-Max  Combined  
13  133.3   1.3  3.5  3.8  -4.4  10.7   Dial  Combined  
 Digital 
31  131.3   0.5  2.7  5.2  -6.7  11.4  Standard Fluid (2)  Stand-alone  
Digital 
25  130.3   0.5  4.5  1.5  2.2  9.5   Standard Fluid  Stand-alone  
8  125.3   3.8  2.9  6.0  -7.1  14.4   n/a  Stand-alone  
3  123.0   12.3  3.0  5.3  -12.8  23.6   Standard Fluid  Combined  
41  120.3   2.3  -0.2   9.6  -20.7  19.8   Standard Fluid  Combined  
30  79.8  1.5  2.5  4.5  -7.2  33.4   Standard Fluid  Combined  
43  65.0  44.0  3.3  2.6  -1.3  15.9   Standard Fluid (2)  Combined  
24  43.8  2.5  3.7  2.6  -1.9  25.8   Digital, Min-Max  Combined  
17  43.3  5.0  2.4  3.7  -1.6  30.8   Standard Fluid  Combined  
5  37.5  3.8  -0.3   4.6  -10.9  26.3   Standard Fluid (2)  Combined  
Digital, Min-Max 
Min-Max, Mercury 
23  30.0  14.3  -3.7   9.5  -35.7  15.6   Standard Fluid  Combined  
Continued on next page  
 
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   37  
   
   
 
Appendix E, continued 
 
Selected Vaccines for Children Program Providers With Storage Units Outside the Required Temperature Range During a 2-Week 
Period 
Table E-1 (contd):  Twenty-eight Freezers  Above 5F for at Least 5 Cumulative Hours 
Longest  
Cumulative Hours  Consecutive  Mean Temperature  Standard Deviation   Temperature Range 
Above Required    Hours Above   During Entire  During Entire  During Entire 
Provider   Range   Required Range   2-Week Period (F)   2-Week Period (F)  2-Week Period (F)   Thermometer Type(s)   Unit Type  
11  27.0  10.3  0.7  2.5  -2.9  11.4   Dial  Combined  
Digital, Min-Max 
40  24.3  1.3  -2.3   5.5  -14.0  25.4   Standard Fluid  Combined  
Dial 
39  19.5  1.3  0.6  2.7  -2.9  16.9   Standard Fluid (2)  Combined  
Digital, Min-Max 
44  16.0  1.3  0.6  4.3  -8.8  36.1   Standard Fluid  Combined  
37  15.3  1.0  1.5  2.2  -3.9  16.8   Digital, Min-Max  Combined  
Digital, Min-Max 
6  12.5  1.3  -2.4   3.3  -8.0  14.1   Standard Fluid  Combined  
Dial (2)  
Digital, Min-Max (2) 
7  11.3  0.8  0.2  2.6  -2.6  21.7   Standard Fluid  Combined  
4  11.0  0  -2.7   2.7  -6.3  10.5   Standard Fluid (2)  Combined  
12  10.3  1.0  -0.3   3.3  -9.2  11.6   Digital, Min-Max  Combined  
21  9.0  8.8  -1.8   2.0  -4.2  11.6   Standard Fluid  Stand-alone  
Digital, Min-Max 
Digital, part of unit 
29  5.0  0.5  -10.1   3.5  -16.2  11.5   Standard Fluid, Min-Max (2)   Combined  
Continued on next page  
 
 
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   38  
   
   
 
Appendix E, continued 
 
Selected Vaccines for Children Program Providers With Storage Units Outside the Required Temperature Range During a 2-Week 
Period 
Table E-2:  Twenty-two  Refrigerators Above 46.4F, Below  35.6F, or Both for at Least 5 Cumulative Hours  
Longest   Longest   Mean  Standard 
Cumulative   Consecutive  Cumulative   Consecutive  Temperature  Deviation   Temperature 
Hours Above   Hours Above   Hours Below   Hours Below   During Entire  During Entire  Range  During 
Required   Required  Required  Required  2-Week Period   2-Week Period   Entire 2-Week  Thermometer 
Provider   Range   Range   Range   Range   (F)   (F)  Period (F)   Type(s)  Unit  Type  
Digital, Min-Max 
14  264.8   34.0  0  0  47.0  0.9  41.9  50.4   Standard Fluid  Combined  
Digital 
36  10.3  2.3  0  0  44.1  0.9  41.9  52.2   Digital, Min-Max  Combined  
12  5.3  1.5  0  0  43.6  1.6  40.3  60.3   Digital, Min-Max  Combined  
3  5.0  1.0  15.3  0.5  40.7  2.9  33.1  59.0   Standard Fluid  Combined  
11  0  0  294.8   10.3  34.3  1.4  32.2  40.6   Dial  Combined  
Continuous Digital, 
18  1.5  1.0  284.3   12.3  30.7  5.1  25.0  58.1   Min-Max  Pharmacy  
Dial 
20  0  0  171.0   20.0  35.1  2.8  25.1  41.2   Digital, Min-Max  Combined  
4  0  0  134.3   1.5  36.1  1.4  32.9  43.6   Digital, Min-Max  Combined  
Dial 
Digital 
21  2.8  1.5  123.3  6.5  35.4  5.5  20.7  54.4   Standard Fluid  Dorm-style  
19  0  0  108.3   1.3  36.7  2.1  31.5  44.1   Digital, Min-Max (3)   Combined  
41  0  0  91.8  2.0  38.1  3.7  28.4  45.2   Standard Fluid  Combined  
10  0  0  67.3  0.5  38.1  2.5  32.7  44.0   Standard Fluid  Combined  
32  1.8  1.8  52.0  0.8  39.6  3.2  33.4  48.3   Digital, Min-Max  Combined  
5  0  0  50.0  3.8  38.7  2.7  29.9  45.2   Standard Fluid (2)  Combined  
17  0  0  49.3  0.3  36.4  0.8  34.5  40.8   Standard Fluid  Combined  
Digital 
42  1.3  1.3  35.5  7.0  36.2  1.1  33.7  49.0   Standard Fluid  Combined  
30  0  0  34.3  1.8  38.9  2.4  31.0  44.3   Standard Fluid  Combined  
Dial 
Digital, Min-Max 
28  0  0  31.0  1.0  37.8  1.9  32.4  44.9   Standard Fluid  Combined  
Continued on next page  
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   39  
   
   
 
Appendix E, continued 
 
 
Selected Vaccines for Children Program Providers With Storage Units Outside the Required Temperature Range During a 2-Week 
Period 
Table E-2 (contd):  Twenty-two  Refrigerators Above 46.4F, Below  35.6F, or Both for at Least 5 Cumulative  Hours  
Longest   Longest   Mean  Standard 
Cumulative   Consecutive  Cumulative   Consecutive  Temperature  Deviation   Temperature 
Hours Above   Hours Above   Hours Below   Hours Below   During Entire  During Entire  Range  During 
Required   Required  Required  Required  2-Week Period   2-Week Period   Entire 2-Week  Thermometer 
Provider   Range   Range   Range   Range   (F)   (F)  Period (F)   Type(s)  Unit  Type  
Digital, Min-Max 
6  0.3  0.3  25.8  1.3  39.6  2.5  32.1  46.7   Standard Fluid  Combined  
7  0.8  0.5  18.5  1.0  39.8  2.0  28.7  48.9   Digital, Min-Max (2)   Combined  
2  3.8  3.0  13.3  0.3  38.7  2.2  34.1  59.5   Digital, Min-Max  Combined  
27  0  0  12.5  0.3  38.0  1.4  34.2  43.7   Standard Fluid  Combined  
Sources:  Sensitech analysis of TempTale data and OIG observations, 2011. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   40  
   
   
 
APPENDIX F 

 
 
Vaccines for Children Program Vaccine Management Requirements That Providers Did Not Meet 
Total   Category of Requirements 
Categories  Vaccine  Vaccine  Vaccine 
With   Vaccine  Vaccine  Storage and   Security and  Ordering and  Receiving 
Requirements  Storage  Storage  Temperature  Handling  Vaccine  Vaccine  Equipment  Inventory  Vaccine  Vaccine 
Provider   Not Met   Equipment   Practices   Monitoring   Plans   Personnel   Waste   Maintenance   Management   Shipments   Preparation  
1  9  X  X  X  X  X  X  X  X  X    
2  8  X  X  X  X  X  X  X        X 
3  8  X  X  X  X  X  X  X  X       
4  8  X  X  X  X  X  X  X     X    
5  8  X  X  X  X  X  X  X     X    
6  8  X  X  X  X  X  X     X  X    
7  8  X  X  X  X  X  X     X  X    
8  7  X  X  X  X  X  X     X       
9  7  X  X  X  X  X  X  X          
10  7  X  X  X  X  X  X  X          
11  7  X  X  X  X  X  X  X          
12  7  X  X  X  X  X  X        X    
13  7  X  X  X  X  X  X     X       
14  7  X  X  X  X  X  X        X    
15  7  X  X  X  X  X  X     X       
16  7  X  X  X  X  X  X        X    
17  7  X  X  X  X     X  X     X    
18  7  X     X  X  X  X  X  X       
19  7  X     X  X  X  X     X  X    
20  6  X  X  X  X  X  X             
21  6  X  X  X  X  X  X             
22  6  X  X  X  X  X     X          
23  6  X  X  X  X  X           X    
Continued on next page  
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   41  
   
   
 
Appendix F, continued 
Vaccines for Children  Program Vaccine Management Requirements That Providers Did Not Meet 
Total    Category of Requirements 
Categories  Vaccine  Vaccine  Vaccine 
With   Vaccine  Vaccine  Storage and   Security and  Ordering and  Receiving  
Requirements  Storage  Storage  Temperature  Handling  Vaccine  Vaccine  Equipment  Inventory  Vaccine  Vaccine 
Provider   Not Met   Equipment   Practices   Monitoring   Plans   Personnel   Waste   Maintenance   Management   Shipments   Preparation  
24  6  X  X  X  X  X        X       
25  6  X  X  X  X        X  X       
26  6  X  X  X  X           X  X    
27  6  X  X  X     X  X     X       
28  6  X  X  X     X     X     X    
29  6  X  X  X     X        X  X    
30  6  X  X     X  X     X  X       
31  5  X  X  X  X  X                
32  5  X  X  X  X  X                
33  5  X  X  X  X  X                
34  5  X  X  X  X  X                
35  5  X  X  X  X        X          
36  5  X  X  X     X        X       
37  5  X  X  X     X  X             
38  5  X  X  X     X     X          
39  5  X     X  X  X     X          
40  5     X  X  X  X  X             
41  4  X  X     X        X          
42  4  X  X     X           X       
43  4     X  X  X  X                
44  3  X  X     X                   
45  2  X  X                         
  Total   N/A   43  42  40  38  37  24  18  17  14  1 
  Source:  OIG observations and analysis of  selected VFC provider interview responses and  documentation, 2011. 
 
 
 
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   42  
   
   
 
APPENDIX G 

 
 
Required Vaccines for Children Program Documents Not Provided by Providers  
Documentation Demonstrating the 
Total Number of   Process To Ensure That Vaccines for  Routine  Current  2010 
Required  Children (VFC) Vaccines Are   Storage and   Emergency   Provider  Current  Temperature- 
Documents Not  Training   Administered Only to the VFC-Eligible  Handling  Storage and   Enrollment  Provider  Monitoring   
Provider    Provided  Records  Population   Plan  Handling Plan   Form   Profile Form   Logs  
18  6  X  X  X  X  X  X    
5  5  X  X  X  X   
4  5  X     X  X  X  X    
20  4  X  X  X  X          
13  4  X     X  X   
15  3  X  X              X 
6  3  X           X  X    
7  3  X     X  XX           
11  3  X     X  X          
16  3  X     X  X          
19  3  X     X  XX           
32  3  X        X        X 
14  3  X           X  X    
39  3  X           X  X    
1  3     X  X  X          
12  2  X  X                
21  2  X  X                
22  2  X  X                
23  2  X  X                
25  2  X  X                
31  2  X  X                
36  2  X  X                
 
Continued on next page  
 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   43  
   
   
 
Appendix G, continued 
 
 
Required Vaccines for Children Program Documents Not Provided by Providers  
Total Number of   Documentation Demonstrating the  Routine  Current  2010 
Required  Process To Ensure That VFC  Storage and   Emergency   Provider  Current  Temperature- 
Documents Not  Training   Vaccines Are Administered  Only  to   Handling  Storage and   Enrollment  Provider  Monitoring   
Provider    Provided  Records  the VFC-Eligible Population   Plan  Handling Plan   Form   Profile Form   Logs  
40  2  X  X                
43  2  X  X                
10  2  X     X             
27  2  X                 X 
8  2        X  X          
9  2        X  X          
17  2        X  X          
42  2              X  X    
2  1  X                   
24  1  X                   
28  1  X                   
29  1  X                   
33  1  X                   
37  1  X                   
38  1  X                   
41  1     X                
3  0                      
26  0                      
30  0                      
34  0                      
35  0                      
44  0                      
45  0                      
Total     32  15  14  12  8  8  3 
Source:  OIG analysis of  selected VFC provider documentation, 2011. 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   44  
   
   
 
APPENDIX H 

 
Activities Missing From Selected Grantees Vaccines for Children Program Fraud and Abuse Policies  
Develop a Procedure 
Compare Enrolled  for Reporting  Develop a  Create an   Create a Protocol  Develop a  Develop 
Total   Providers to  Vaccines for Children  Fraud and  Allegation and  Identify   To Annually   Procedure for  Training  
Activities Not   Exclusion  (VFC) Provider  Abuse Referral  Referral  Oversight  Review the Fraud  Monitoring the   Materials for 
Grantee   Included   Databases   Terminations   Procedure   Database   Personnel   and Abuse Policy   VFC Program   VFC Personnel  
1  6  X  X  X  X  X  X       
2  8  X  X  X  X  X  X  X  X 
3  6  X  X     X  X  X     X 
4  3  X  X  X                
5  5  X  X  X  X        X    
Total    5  5  4  4  3  3  2  2 
Source:  Office of  Inspector General analysis of  selected grantees fraud and abuse policies, 2011.  Requirements established in the  VFC Operations Guide, Module 10:  Fraud and Abuse. 
 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   45  
   
   
 
APPENDIX I 

Agency Comments 

 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   46  
  Appendix I, continued 
CDC Response: CDC concurs with this recommendation and is committed to protecting public 
investments in life saving vaccines and ensuring propel' vaccine storage and handling. We 
recognize that proper vaccine management is a collaborative effort between the agency, 
immunization grantees, and the nearly 45,000 participating VFC provider sites. 
CDC is comllutted to the continuous quality improvement of guidance documents, program 
requirements, and support materials for vaccine management, as well as storage and handling at 
the provider and grantee level. In addition, CDC will work with its partners, including state 
health officials, immunization program managers, and professional organizations to research and 
identify strategies 10 improve compliance with equipment requirementS and temperature 
monitoring for proper vaccine storage. 
OlG Recommendation: Ensure expired vaccines are identified and separated from viable 
vaccines. 
CDC Response: CDC concurs with this recommendation. CDC is in the process of 
implementing significant changes in how VFC vacdnes are ordered and provider inventories are 
reported. Through changes in the vaccine ordering systems and processes, CDC is expecting,to 
improve vaccine accounting in the provider office and forecasting of their vaccine supply needs. 
The end result will be better vaccine management and reduced risk of ~xpired and soon-Io-be 
expired vaccine. With less expired vaccine in the provider office, a lower risk of expired vaccine 
being comillgled with viable stock will exist. CDC will also review its guidance and training 
materials to ensure pl'Ogram requirements related to expired vaccine management are clear, well
communicated, and understood by grantees and providers. 
OIG Recommendation: Ensure grantees establish provider inventory systems and procedures to 
better manage soon-to-expire vaccines. 
CDC Re.~ponse: CDC concurs with this recommendation. As stated above, CDC is in the 
process of implementing sigl'Jficant changes in how VFC vaccines are ordered and provider 
inventories are reported. Through changes in the vaccine ordering systems and processes, CDC 
is expecting vaccine supply forecasting by providers to improve. The end result will be better 
vaccine management and reduced risk of expired and soon-to-be expired vaccines. As CDC 
continues to U'ansform the vaccine ordering and information systems, it will incorporate OIG's 
recommendations. 
OlG Recommendation: Ensure grantees meet oversight requirements. 
CDC Response: CDC concurs with this recommendation and is committed to maintaining the 
integrity of the VFC program through effective management and oversight. CDC also 
understands the need to minimize the burden of administrative and record keeping requirements 
on VFC providers. CDC will work with its grantees and provider organizations to ensure 
program requirements are necessary for effective oversight of the program. In addition, working 
groups will review VFC provider site visit procedLU'es and documentation to ensure they can be 
effective in enforcing program requirements. 
'rhomos R. Frieden, M.D., M.P.H. 
2 
Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-1 0-00430)  47   
   
 
ACKNOWLEDGMENTS 
This report was prepared under the direction of Dwayne Grant, Regional 
Inspector General for Evaluation and Inspections in the Atlanta regional 
office, and Jaime Durley, Deputy Regional Inspector General.   
Holly Williams served as the lead analyst for this study.  Other principal 
Office of Evaluation and Inspections staff from the Atlanta regional office 
who contributed to the report include Sarah McLaulin and Latrice Rollins; 
central office staff who contributed include Kevin Farber, and 
Talisha Searcy.  
We would also like to acknowledge the contributions of other Office of 
Evaluation and Inspections regional office staff, including Sarah Ambrose, 
Teresa Dailey, Conswelia McCourt, and Brian Pattison. 
 
 
Vaccines for Children Program:  Vulnerabilities in Vaccine Management (OEI-04-10-00430)   48  
   
   
 
Office of Inspector General 

http://oig.hhs.gov  
 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, is  
to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as the 
health and welfare of beneficiaries served by those programs.  This statutory mission is carried out through 
a nationwide network of audits, investigations, and inspections conducted by the following operating 
components: 
Office of Audit Services 
The Office of Audit Services (OAS) provides auditing services for HHS, either by conducting audits with 
its own audit resources or by overseeing audit work done by others.  Audits examine the performance of  
HHS programs and/or its grantees and contractors in  carrying out their respective responsibilities and are  
intended to provide independent assessments of HHS programs and operations.  These assessments help 
reduce waste, abuse, and mismanagement and promote economy and efficiency throughout HHS. 
Office of Evaluation and Inspections  
The Office of Evaluation and Inspections (OEI) conducts national evaluations to provide HHS, Congress, 
and the public with timely, useful, and reliable information on significant issues.  These evaluations focus 
on preventing fraud, waste, or abuse and promoting economy, efficiency, and effectiveness of  
departmental programs.  To promote impact, OEI reports also present practical recommendations for 
improving program operations.  
Office of Investigations 
The Office of Investigations (OI) conducts criminal, civil, and administrative investigations of fraud and 
misconduct related to HHS programs, operations, and beneficiaries.  With investigators working in all 
50 States and the District of Columbia, OI utilizes its resources by actively coordinating with the  
Department of Justice and other Federal, State, and local law enforcement authorities.  The investigative 
efforts of OI often lead to criminal convictions, administrative sanctions, and/or civil monetary penalties. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering 
advice and opinions on HHS programs and operations and providing all legal support for OIGs internal  
operations.  OCIG represents OIG in all civil and administrative fraud and abuse cases involving HHS 
programs, including False Claims Act, program exclusion, and civil monetary penalty cases.  In  
connection with these cases, OCIG also negotiates and monitors corporate integrity agreements.  OCIG 
renders advisory opinions, issues compliance program guidance, publishes fraud alerts, and provides other 
guidance to the health care industry concerning the anti-kickback statute and other OIG enforcement 
authorities.