Department of Health and Human Services
 

OFFICE OF 

INSPECTOR GENERAL 

VACCINES FOR CHILDREN 

PROGRAM:
 

VULNERABILITIES IN 

VACCINE MANAGEMENT
 

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 Prevention’s (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 Prevention’s (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 program’s 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-vfcresolutions.htm on September 13, 2010.
 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 1 
 

 

 

 

 

 

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. 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 2 
 

 

 

 

 

 

 

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 CDC’s 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 provider’s 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 FDA’s 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-chaptrfiles.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 5°F reduces the vaccine’s 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 

refrigerators—such 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 35°F and 46°F, 

and vaccines requiring freezer storage must be stored at or below 5°F .

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 

33, 34 expired vaccines are not administered. 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 2°C and 8°C (which convert to 35.6°F and 46.4°F, respectively) and vaccines 

requiring freezer storage must be stored at or below -15°C (which converts to 5.0°F). 

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 CDC’s 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 

provider’s 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.
 

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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 provider’s 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-chaptrfiles.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 Questionnaire—updated periodically—that 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 CDC’s 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 CDC’s 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 grantee’s 

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 provider’s VFC coordinator(s) on the 

provider’s 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 device—TempTale®—that 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 CDC’s 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 TempTale®4 monitors (TempTale®) and analytic services from a qualified contractor. The 

TempTale® monitor temperature range is -22.0°F to 158.0°F and the accuracy range is ±2.0°F from -22.0°F to 

0°F, ±1.0°F from 0°F to 122.0°F, and ±2.0°F from 122.0°F to 158.0°F. 

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. 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 9 
 

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 provider’s 

thermometer, we placed the TempTale® next to the probe of the provider’s 

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 documentation—such as training materials, program guidance, 

and records of their provider site visits—to 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 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 10 
 

 

 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 11 

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 5.0°F was considered out of 

range for freezers, and any temperature lower than 35.6°F or higher than 

46.4°F 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 (5°F, 35°F, and 46°F) 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 

≤ 3°F on many providers’ temperature logs. In these instances, we assumed the recorded temperature was 3°F 

and calculated a difference only if the TempTale® temperature for the same time was greater than 3°F. 

Comparison was not possible for seven providers’ freezers. 
 

 

 

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. 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 12 
 

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 device’s accuracy range. The accuracy range for 

TempTale® devices is ±2°F from -22°F to 0°F and ±1°F from 0°F to 

122°F. 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. 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 13 
 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 14 

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 percent—34 of 45—of 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 (5°F) for at least 5 cumulative hours during the 2-week 

period.56, 57 Eleven of these providers’ freezers were above 5°F for more 

than 120 hours, representing at least 36 percent of the total 2-week period 

of our independent temperature measurement. One provider’s freezer was 

above 5°F 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 33°F during the 2-week period, and one 

of these reached 44°F. Exposure to temperatures above 5°F 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 ±2°F from -22°F to 0°F and ±1°F 

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

of the required range, and 93 percent of our independently measured freezer temperatures were within 2°F.
 
 

 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 15 

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 46°F, below 35°F, or both) for at least 5 cumulative hours during 

the 2-week period.58 Four providers’ refrigerated vaccines were exposed 

to temperatures above 46°F for at least 5 cumulative hours during the 

2-week period, and 19 providers’ refrigerated vaccines were exposed to 

temperatures below 35°F for at least 5 hours. One provider’s refrigerated 

VFC vaccines were exposed to temperatures both above 46°F and below 

35°F for at least 5 hours during the 2-week period. The highest and lowest 

independently measured refrigerator temperatures among the 

22 refrigerators were 60°F and 21°F, 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 

provider’s refrigerator that was above 46°F 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 32°F) during the 2-week period, and one refrigerator storing 

VFC vaccines had an average temperature below 32°F 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 ±1°F from 0°F to 122°F. 

Ninety-two percent of our independently measured refrigerator temperatures were within ±1°F of the required 

range. 
 

 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 16 

 

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 17°F. This provider recorded a temperature of 40°F on 

the temperature-monitoring log, while the TempTale® recorded a 

temperature of 23°F 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 

4°F and 2°F, 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 

≤ 3°F on many providers’ temperature logs. In these instances, we assumed the recorded temperature was 3°F 

and calculated a difference only if the TempTale® temperature for the same time was greater than 3°F. 

Comparison was not possible for seven providers’ freezers. 
 

 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 17 

 

 

 

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 

2‐week 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.
 
 

 

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 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 18 
 

 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 19 

 

 

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 

Category of Vaccine Management 

Requirements 

Number of Providers 

That Did Not Meet All 

Requirements in 

Category 

(n=45) 

Percentage of Providers 

That Did Not Meet All 

Requirements in 

Category 

(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 38°F with a standard deviation 

of 4°F. In contrast, combined units had an average temperature of 39°F with a standard deviation of 2°F and 

stand-alone units averaged 40°F with a standard deviation of 1°F. The overall standard deviation for all 

refrigerators we observed was 2°F. Sensitech analysis of TempTale® data, 2011. 
 

 

 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 20 

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. 
 

 

 

 

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 

Required Document 

Number of Selected 

VFC Providers 

Without Document 

(n=45) 

Percentage of 

Selected VFC 

Providers Without 

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, 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 21 
 

 

 

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 provider’s 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 

grantee’s fraud and abuse policy. 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 22 
 

 

Table 3: Number and Percentage of Selected Grantees Whose Fraud and Abuse 

Policies Did Not Include Each Required Activity 

Required Activity 

Number of Grantees’ 

Fraud and Abuse 

Policies Without 

Required Activity 

(n=5) 

Percentage of 

Grantees’ Fraud and 

Abuse Policies 

Without Required 

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 
 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 24 

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 visit—did 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. 
 

 

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 percent—34 of 45—of 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 

temperature‐monitoring 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 CDC’s efforts to address these issues and encourage it to 

continue making progress. For the full text of CDC’s comments, see 

Appendix I. 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 28 
 

 

APPENDIX A 

Vaccines for Children Program Vaccines and Required Storage Temperatures 

Vaccines That Must Be Stored Between 35°F and 46°F 

Vaccine Brand Manufacturer 

Diphtheria and Tetanus Toxoids and Acellular 

Pertussis Vaccine Adsorbed (DtaP) Daptacel 

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 

Conjugate) (Hib) ActHIB Sanofi Pasteur, Inc. 

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 

Fluvirin 

Novartis Vaccines and Diagnostics 

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 

Vaccine Menveo 

Novartis Vaccines and Diagnostics, 

Inc. 

continued on next page 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 29 
 

 

 

Appendix A, continued 

Vaccines for Children Program Vaccines and Required Storage Temperatures 

Vaccines That Must Be Stored Between 35°F and 46°F 

Vaccine Brand Manufacturer 

Pneumococcal 13-valent Conjugate Vaccine 

(Diphtheria CRM197 Protein) (PCV) Prevnar 13 Wyeth Pharmaceuticals Inc. 

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 

Acellular Pertussis Vaccine, Adsorbed (Tdap) Adacel Sanofi Pasteur, Inc. 

Boostrix GlaxoSmithKline Biologicals 

Vaccines That Must Be Stored at or Below 5°F 

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 Prevention’s (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 year’s 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 manufacturer’s 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 

Vaccine Storage 

Equipment 

.... At the grantee’s discretion, providers may use dormitory-style refrigerators to temporarily store a 

clinic’s single-day supply of refrigerated vaccines. The freezer portion of a dormitory-style refrigerator 

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. 

Vaccine Storage 

Practices 

The vaccine storage practices ... are the responsibility of the provider/clinic vaccine coordinator or the 

vaccine coordinator’s 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 

expiration dates; check for short-dated vaccine. 

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 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 31 
 

 

 

Appendix B, continued 

Vaccines for Children Program Vaccine Management Requirements for Providers 

Requirement 

Category Required Activities 

Vaccine Storage 

Practices (cont’d) 

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. 

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 

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 

temperatures are between 35°F and 46°F. The freezer temperature should be 5°F or lower. Twice-daily 

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. 

Vaccine Storage 

and Handling 

Plans 

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 

compromise appropriate vaccine storage conditions. Please refer to “Emergency Vaccine Retrieval and 

Storage Plan Worksheet” found in the Vaccine Storage and Handling Toolkit. 

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 

Vaccines for Children Program: Vulnerabilities in Vaccine Management (OEI-04-10-00430) 32 
 

 Appendix B, continued 

Vaccines for Children Program Vaccine Management Requirements for Providers 

Requirement 

Category Required Activities 

Vaccine 

Personnel 

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 

temperature logs for each storage unit twice a day. 

Train other staff who are responsible for administering vaccines or who may be required to transport 

vaccine in an emergency situation, following the office’s vaccine storage and handling plan. A simple log 

sheet with the staff member’s 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. 

Vaccine Waste 

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, 

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 

and Equipment 

Maintenance 

Post “DO NOT DISCONNECT” notices at both the electrical outlet and the circuit breaker to prevent power 

from being disconnected. 

Vaccine Ordering 

and Inventory 

Management 

Order vaccine in accordance with actual vaccine need. 

Develop and maintain complete, accurate, and separate stock records for both publicly and privately 

purchased vaccines. The requirement to keep separate records does not necessitate having separate 

storage units for public and private vaccines. Providers must be able to distinguish between their public 

and private vaccine stock. 

Receiving 

Vaccine 

Shipments 

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. 

Immediately upon delivery of vaccine, check the vaccine cold chain monitors, if included, and store vaccine 

according to manufacturers’ product specifications. 

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 

Receiving 

Vaccine 

Shipments 

(cont’d) 

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. 

If the provider believes that a vaccine shipment is compromised, temperature monitors are out of range, or 

a heat monitor is not activated (i.e., turned on), the provider should also contact McKesson Customer 

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. 

Vaccine 

Preparation 

The National Center for Immunization and Respiratory Diseases (NCIRD), Centers for Disease Control and 

Prevention, strongly recommends that providers draw vaccine only at the time of administration to ensure 

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 

Grantee 

Vaccine Doses 

Ordered 

Percentage of Total Vaccine 

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 

Characteristic

 Number of Vaccines for 

Children (VFC) 

Providers in Population 

for Selected Grantees 

Percentage of VFC 

Providers in 

Population for 

Selected Grantees 

Number of VFC 

Providers in 

Sample 

Percentage of 

VFC Providers 

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 DurinPeriod Table E-1: Twenty-eight Freezers Above 5°F for at Least 5 Cumulative Hours 

Provider 

Cumulative Hours 

Above Required 

Range 

Longest Consecutive 

Hours Above 

Required Range 

Mean Temperature 

During Entire 

2-Week Period (°F) 

Standard Deviation 

During Entire 

2-Week Period (°F)

 Temperature Range 

During Entire 2-Week 

Period (°F) Thermometer Ty

28 316.5 43.8 8.1 4.3 4.6 – 28.3 

Digital, Min

 Standard 

27 202.0 23.3 5.6 1.6 1.9 – 16.2 Standard 

10 195.3 3.0 5.7 2.7 -2.1 – 15.1 Standard 36 162.0 2.3 5.6 2.8 2.7 – 22.3 

Digital, Min

20 138.5 20.0 3.4 6.5 -11.4 – 44.3 

Digital, Min

13 133.3 1.3 3.5 3.8 -4.4 – 10.7 

31 131.3 0.5 2.7 5.2 -6.7 – 11.4

 

Standard Flu

25 130.3 0.5 4.5 1.5 2.2 – 9.5 

Standard 

8 125.3 3.8 2.9 6.0 -7.1 – 14.4 

3 123.0 12.3 3.0 5.3 -12.8 – 23.6 Standard 

41 120.3 2.3 -0.2 9.6 -20.7 – 19.8 Standard 30 79.8 1.5 2.5 4.5 -7.2 – 33.4 Standard 

43 65.0 44.0 3.3 2.6 -1.3 – 15.9 Standard Flu

24 43.8 2.5 3.7 2.6 -1.9 – 25.8 Digital, Min

17 43.3 5.0 2.4 3.7 -1.6 – 30.8 Standard 

5 37.5 3.8 -0.3 4.6 -10.9 – 26.3 Standard Flu

23 30.0 14.3 -3.7 9.5 -35.7 – 15.6 

Digital, Min

Min-Max, Me

Standard 

Continued on 

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 DurinPeriod Table E-1 (cont’d): Twenty-eight Freezers Above 5°F for at Least 5 Cumulative Hours Provider 

Cumulative Hours 

Above Required 

Range 

Longest 

Consecutive 

Hours Above 

Required Range 

Mean Temperature 

During Entire 

2-Week Period (°F) 

Standard Deviation 

During Entire 

2-Week Period (°F)

 Temperature Range 

During Entire 

2-Week Period (°F) Thermometer Ty

11 27.0 10.3 0.7 2.5 -2.9 – 11.4 40 24.3 1.3 -2.3 5.5 -14.0 – 25.4 

Digital, Min

Standard 

39 19.5 1.3 0.6 2.7 -2.9 – 16.9 

Standard Flu

44 16.0 1.3 0.6 4.3 -8.8 – 36.1 

Digital, Min

Standard 

37 15.3 1.0 1.5 2.2 -3.9 – 16.8 Digital, Min

6 12.5 1.3 -2.4 3.3 -8.0 – 14.1 

Digital, Min

Standard 

7 11.3 0.8 0.2 2.6 -2.6 – 21.7 

D

Digital, Min-M

Standard 

4 11.0 0 -2.7 2.7 -6.3 – 10.5 Standard Flu

12 10.3 1.0 -0.3 3.3 -9.2 – 11.6 Digital, Min21 9.0 8.8 -1.8 2.0 -4.2 – 11.6 Standard 

29 5.0 0.5 -10.1 3.5 -16.2 – 11.5 

Digital, Min

Digital, part 

Standard Fluid, Min-M

Continue

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 DurinPeriod Table E-2: Twenty-two Refrigerators Above 46.4°F, Below 35.6°F, or Both for at Least 5 Cumulative Hours Provider 

Cumulative 

Hours Above 

Required 

Range 

Longest 

Consecutive 

Hours Above 

Required 

Range 

Cumulative 

Hours Below 

Required 

Range 

Longest 

Consecutive 

Hours Below 

Required 

Range 

Mean 

Temperature 

During Entire 

2-Week Period 

(°F) 

Standard 

Deviation 

During Entire 

2-Week Period 

(°F)

 Temperature 

Range During 

Entire 2-Week 

Period (°F) 

Therm

14 264.8 34.0 0 0 47.0 0.9 41.9 – 50.4 

Digital, 

Standa

36 10.3 2.3 0 0 44.1 0.9 41.9 – 52.2 

Digital, 

12 5.3 1.5 0 0 43.6 1.6 40.3 – 60.3 Digital, 3 5.0 1.0 15.3 0.5 40.7 2.9 33.1 – 59.0 Standa

11 0 0 294.8 10.3 34.3 1.4 32.2 – 40.6 

18 1.5 1.0 284.3 12.3 30.7 5.1 25.0 – 58.1 

Continuou

20 0 0 171.0 20.0 35.1 2.8 25.1 – 41.2 

Digital, 

4 0 0 134.3 1.5 36.1 1.4 32.9 – 43.6 Digital, 

21 2.8 1.5 123.3 6.5 35.4 5.5 20.7 – 54.4 

Standa

19 0 0 108.3 1.3 36.7 2.1 31.5 – 44.1 Digital, Min

41 0 0 91.8 2.0 38.1 3.7 28.4 – 45.2 Standa

10 0 0 67.3 0.5 38.1 2.5 32.7 – 44.0 Standa

32 1.8 1.8 52.0 0.8 39.6 3.2 33.4 – 48.3 Digital, 

5 0 0 50.0 3.8 38.7 2.7 29.9 – 45.2 Standard 

17 0 0 49.3 0.3 36.4 0.8 34.5 – 40.8 Standa42 1.3 1.3 35.5 7.0 36.2 1.1 33.7 – 49.0 

Standa

30 0 0 34.3 1.8 38.9 2.4 31.0 – 44.3 Standa28 0 0 31.0 1.0 37.8 1.9 32.4 – 44.9 

Digital, 

Standa

Con

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 DurinPeriod Table E-2 (cont’d): Twenty-two Refrigerators Above 46.4°F, Below 35.6°F, or Both for at Least 5 Cumulative Hours Provider 

Cumulative 

Hours Above 

Required 

Range 

Longest 

Consecutive 

Hours Above 

Required 

Range 

Cumulative 

Hours Below 

Required 

Range 

Longest 

Consecutive 

Hours Below 

Required 

Range 

Mean 

Temperature 

During Entire 

2-Week Period 

(°F) 

Standard 

Deviation 

During Entire 

2-Week Period 

(°F)

 Temperature 

Range During 

Entire 2-Week 

Period (°F) 

Therm

6 0.3 0.3 25.8 1.3 39.6 2.5 32.1 – 46.7 

Digital, 

Standa

7 0.8 0.5 18.5 1.0 39.8 2.0 28.7 – 48.9 Digital, Min

2 3.8 3.0 13.3 0.3 38.7 2.2 34.1 – 59.5 Digital, 

27 0 0 12.5 0.3 38.0 1.4 34.2 – 43.7 Standa

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 Provider 

Total 

Categories 

With 

Requirements 

Not Met 

Category of Requirements 

Vaccine 

Storage 

Equipment 

Vaccine 

Storage 

Practices 

Temperature 

Monitoring 

Vaccine 

Storage and 

Handling 

Plans 

Vaccine 

Personnel 

Vaccine 

Waste 

Vaccine 

Security and 

Equipment 

Maintenance 

Vaccine 

Ordering and 

Inventory 

Managemen

1 9 X X X X X X X X 2 8 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 

5 8 X X X X X X X 

6 8 X X X X X X X 

7 8 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 

13 7 X X X X X X X 

14 7 X X X X X X 

15 7 X X X X X X X 

16 7 X X X X X X 

17 7 X X X X X X 

18 7 X X X X X X X 

19 7 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 

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 Provider 

Total 

Categories 

With 

Requirements 

Not Met 

Category of Requirements 

Vaccine 

Storage 

Equipment 

Vaccine 

Storage 

Practices 

Temperature 

Monitoring 

Vaccine 

Storage and 

Handling 

Plans 

Vaccine 

Personnel 

Vaccine 

Waste 

Vaccine 

Security and 

Equipment 

Maintenance 

Vaccin

Ordering an

Inventor

Managemen

24 6 X X X X X X 

25 6 X X X X X X 26 6 X X X X X 

27 6 X X X X X X 

28 6 X X X X X 

29 6 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 

 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 Provider 

Total Number of 

Required 

Documents Not 

Provided 

Training 

Records 

Documentation Demonstrating the 

Process To Ensure That Vaccines for 

Children (VFC) Vaccines Are 

Administered Only to the VFC-Eligible 

Population 

Routine 

Storage and 

Handling 

Plan 

Emergency 

Storage and 

Handling Plan 

Current 

Provider 

Enrollment 

Form 

P

18 6 X X X X X 

5 5 X X X 

X 

4 5 X X X X 20 4 X X X X 

13 4 X X 

X 

15 3 X X 

6 3 X X 

7 3 X X X 

11 3 X X X 16 3 X X X 19 3 X X X 32 3 X X 

14 3 X X 

39 3 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 

Continue

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 Provider 

Total Number of 

Required 

Documents Not 

Provided 

Training 

Records 

Documentation Demonstrating the 

Process To Ensure That VFC 

Vaccines Are Administered Only to 

the VFC-Eligible Population 

Routine 

Storage and 

Handling 

Plan 

Emergency 

Storage and 

Handling Plan 

Current 

Provider 

Enrollment 

Form 

P

40 2 X X 43 2 X X 10 2 X X 

27 2 X 

8 2 X X 9 2 X X 17 2 X X 

42 2 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 

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 Grantee 

Total 

Activities Not 

Included 

Compare Enrolled 

Providers to 

Exclusion 

Databases 

Develop a Procedure 

for Reporting 

Vaccines for Children 

(VFC) Provider 

Terminations 

Develop a 

Fraud and 

Abuse Referral 

Procedure 

Create an 

Allegation and 

Referral 

Database 

Identify 

Oversight 

Personnel 

Create a Protocol 

To Annually 

Review the Fraud 

and Abuse Policy 

1 6 X X X X X X 

2 8 X X X X X X 

3 6 X X X X X 

4 3 X X X 

5 5 X X X X 

Total 5 5 4 4 3 3 

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 Abu

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, wellcommunicated, 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 OIG’s 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.