TABLE OF CONTENTS
Texas Department of State Health Services Stock No. 11-13602
Immunization Section Page 1 of 152 Rev. 09/2023
INTRODUCTION TO THE 2024 PROVIDER MANUAL FOR THE TEXAS
VACCINES FOR CHILDREN (TVFC) AND ADULT SAFETY NET (ASN)
PROGRAMS _________________________________________________ 9
I. Provider Manual Information ________________________________ 9
II. Public Health Law Establishing the Vaccines for Children (VFC)
Program ________________________________________________ 9
III. Vision and Mission of the DSHS Immunization Program __________ 10
IV. Goals of the DSHS Immunization Program ____________________ 10
V. Goals of the TVFC Program ________________________________ 11
CHAPTER 1: TVFC SITE ELIGIBILITY AND ENROLLMENT _ 13
I. Signing Clinician Eligibility Requirements ______________________ 13
II. Enrollment Requirements _________________________________ 15
A. Specific Terms of Agreement __________________________ 15
B. Site Coordinator Responsibilities _______________________ 17
C. Initial Enrollment ___________________________________ 19
D. TVFC/ASN Enrollment Visit ____________________________ 21
E. TVFC/ASN Site Set-up _______________________________ 24
F. Vaccine Accountability _______________________________ 25
G. Provider Identification Number ________________________ 26
H. Provider Change of Information ________________________ 26
I. Annual Re-Enrollment ________________________________ 27
J. Deputization of Clinics _______________________________ 28
III. Withdrawal from TVFC/ASN ________________________________ 28
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IV. Suspension from TVFC/ASN Programs ________________________ 29
V. Termination from TVFC/ASN _______________________________ 29
VI. Re-enrollment after Termination ____________________________ 30
CHAPTER 2: TVFC PATIENT ELIGIBILITY AND
SCREENING ___________________________________ 31
I. Patient Eligibility Requirements _____________________________ 31
A. TVFC Patient Eligibility Criteria _________________________ 31
B. Children’s Health Insurance Program (CHIP) ______________ 32
C. Medicaid as Secondary Insurance _______________________ 33
D. Nineteen-Year-Olds _________________________________ 33
II. Patient Eligibility Screening Record __________________________ 33
CHAPTER 3: VACCINE MANAGEMENT ________________ 35
I. Approved Vaccines 35
II. Vaccine Ordering 36
A. Vaccine Choice _____________________________________ 36
B. Patient Population Profile Estimates _____________________ 37
C. Vaccine Inventory Plan and Maximum Stock Levels _________ 39
D. Increasing and Decreasing Maximum Stock Levels _________ 40
E. Short-Dated Vaccine _________________________________ 40
F. Storage Capacity for Vaccine Orders ____________________ 41
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G. Vaccine Ordering in the Vaccine Allocation and Ordering
System (VAOS)_____________________________________ 41
H. Vaccine Ordering for Sites without Internet Access _________ 43
I. Vaccine Ordering for Newly Enrolled TVFC/ASN Sites ________ 44
J. Ordering Influenza Vaccine ____________________________ 44
III. Vaccine Distribution ______________________________________ 45
A. Vaccine Distributors _________________________________ 45
B. Receiving Vaccine Orders _____________________________ 45
C. Manufacturer and Distributor Maintenance of the Cold Chain _ 48
D. Vaccines Received Warm or Questionable ________________ 48
E. Vaccines Received in Error ____________________________ 49
IV. Vaccine Loss ___________________________________________ 50
A. Expired, Spoiled and Ruined/Wasted Vaccine ______________ 50
B. Procedures for Vaccine Loss ___________________________ 51
C. Negligent Vaccine Loss _______________________________ 54
D. Non-Negligent Vaccine Loss ___________________________ 55
E. Vaccine Disposal ____________________________________ 56
V. Vaccine Storage and Handling ______________________________ 56
A. Refrigerator and Freezer Requirements __________________ 57
B. Data Logger Requirements ____________________________ 67
C. Vaccine Storage Requirements _________________________ 72
D. Protective Equipment ________________________________ 72
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E. Personnel _________________________________________ 73
F. Routine and Emergency Storage and Handling Plan_________ 74
G. Vaccine Protection in the Event of an Emergency ___________ 76
H. Cold Chain Management and Vaccine Transport ____________ 77
VI. Vaccine Transfers ________________________________________ 86
VII. Vaccine Borrowing _______________________________________ 88
VIII. Reporting Requirements __________________________________ 89
A. Vaccine Ordering for Providers without Internet Access ______ 91
CHAPTER 4: BILLING AND ADMINISTRATION _________ 93
I. Billing for Vaccine 93
II. Administration Fee 93
CHAPTER 5: PROGRAM EVALUATION ________________ 95
I. Standards for Childhood Immunizations ______________________ 95
II. Common Site Visit Structures: Compliance, IQIP, Storage and
Handling _______________________________________________ 96
A. TVFC Compliance Site Visits ___________________________ 97
B. Immunization Quality Improvement for Providers (IQIP) Site
Visits _____________________________________________ 99
C. Unannounced Storage and Handling Visits _______________ 100
III. TVFC Program Electronic Medical Records (EMRs) ______________ 101
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IV. TVFC/ASN Provider Satisfaction Surveys _____________________ 101
A. Annual TVFC/ASN Provider Satisfaction Survey ___________ 101
B. Site Visit Assessment Survey _________________________ 102
CHAPTER 6: FRAUD AND ABUSE __________________ 103
I. Fraud and Abuse _______________________________________ 103
II. Definitions ____________________________________________ 103
III. Examples _____________________________________________ 104
IV. Failure to Comply with TVFC Program Requirements ____________ 105
V. Fraud and Abuse Prevention ______________________________ 105
VI. Reporting Fraud and Abuse _______________________________ 105
CHAPTER 7: DOCUMENTATION REQUIREMENTS ______ 107
I. Vaccine Record Keeping Requirements ______________________ 107
II. The Texas Immunization Registry (ImmTrac2) ________________ 108
A. Reporting Vaccine Eligibility in ImmTrac2________________ 110
B. Reporting Requirements During Disaster Declaration _______ 110
III. Addressing Vaccine Hesitancy _____________________________ 111
IV. Vaccine Adverse Events __________________________________ 111
CHAPTER 8: OFF-SITE AND MASS VACCINATION
CLINICS
____________________________________ 113
A. Vaccine Ordering for Off-Site and Mass Vaccination Clinics __ 113
B. Off-Site and Mass Vaccination Clinic Requirements ________ 114
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CHAPTER 9: ADULT SAFETY NET PROGRAM __________ 117
I. Adult Safety Net (ASN) Overview __________________________ 117
II. ASN Eligible Facility Types ________________________________ 117
III. ASN Enrollment ________________________________________ 118
IV. ASN Patient Eligibility ____________________________________ 118
A. Eligibility Criteria __________________________________ 118
B. Nineteen-Year-Olds ________________________________ 119
C. Patient Eligibility Screening Record ____________________ 119
D. Vaccine Services to Female Veterans ___________________ 121
V. ASN Vaccine Formulary __________________________________ 121
VI. Provider Enrollment Requirements __________________________ 122
A. Specific Terms of Agreement _________________________ 122
B. Initial Enrollment __________________________________ 124
C. ASN Enrollment Visit________________________________ 124
D. ASN Site Set-up ___________________________________ 124
E. Vaccine Accountability ______________________________ 124
F. Provider Identification Number _______________________ 125
G. Provider Change of Information _______________________ 125
H. Annual Re-Enrollment _______________________________ 125
VII. Vaccine Ordering _______________________________________ 126
A. Vaccine Choice ____________________________________ 126
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B. Vaccine Inventory Plan and Maximum Stock Levels ________ 127
C. Increasing and Decreasing Maximum Stock Levels ________ 127
D. Short-Dated Vaccine ________________________________ 127
E. Storage Capacity for Vaccine Orders ___________________ 127
F. Vaccine Ordering in the Vaccine Allocation and Ordering
System (VAOS)____________________________________ 127
G. Vaccine Ordering for ASN Sites without Internet Access ____ 128
H. Vaccine Ordering for Newly Enrolled ASN Sites ___________ 128
VIII. Vaccine Storage ________________________________________ 128
IX. Vaccine Management ____________________________________ 129
X. Vaccine Transfers _______________________________________ 129
XI. ASN Billing and Administration ____________________________ 130
A. Billing for ASN Vaccine ______________________________ 130
B. ASN Administration Fee _____________________________ 130
XII: ASN Site Visits ____________________________________________ 130
A. Adult Immunization Standards ________________________ 130
B. Adult Site Visits ___________________________________ 132
C. Site Visit Scheduling and Clinic Access __________________ 132
D. Components of the ASN Site Visit ______________________ 133
E. Electronic Medical Record (EMR) Review ________________ 133
XIII. Mobile Vaccination Clinics ________________________________ 134
XIV. Reporting Doses Administered ____________________________ 135
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XV. Fraud and Abuse _______________________________________ 135
A. Definitions _______________________________________ 135
B. Example _________________________________________ 135
C. Failure to Comply with ASN Requirements ______________ 136
D. Fraud and Abuse Prevention __________________________ 137
E. Reporting Fraud and Abuse __________________________ 137
CHAPTER 10: VACCINE INFORMATION STATEMENT
(VIS) _______________________________________ 1
39
CHA
PTER 11: ORDERING FORMS AND LITERATURE ___
141
CH
APTER 12: IMMUNIZATION RESOURCES __________
143
Vac
cine Manufacturers Contact List _______________ 145
TVFC/ASN Program Contact Information ___________ 14
7
2024 Manual
Revision History ____________________ 149
INTRODUCTION TO THE 2024 PROVIDER MANUAL
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INTRODUCTION TO THE 2024 PROVIDER
MANUAL FOR THE TEXAS VACCINES FOR
CHILDREN (TVFC) AND ADULT SAFETY NET
(ASN) PROGRAMS
I. Provider Manual Information
The Texas Department of State Health Services (DSHS) Immunization
program prepares the Texas Vaccines for Children (TVFC) and Adult Safety
Net (ASN) Provider Manual. Consultation on the policies in this manual are
conducted routinely with the Centers for Disease Control and Prevention
(CDC), the Center for Medicare and Medicaid Services (CMS), DSHS and
other organizations.
The purpose of the TVFC/ASN Provider Manual is to consolidate ASN
program policies and information into one source. You may consult the
manual as needed, for the handling and management of TVFC/ASN program
vaccines. Throughout the year, the DSHS Immunization program will
announce new policies via official policy letters, memorandums and the
monthly newsletter, “TVFC/ASN Program News”. This manual will undergo a
comprehensive review annually. Both the manual and the latest updates in
the “TVFC/ASN Program News” newsletter can be found on the DSHS
Immunization program website. ASN specific policies are found in Chapter 9.
II. Public Health Law Establishing the Vaccines for
Children (VFC) Program
The federal VFC program is authorized by the Omnibus Budget Reconciliation
Act (OBRA), Section 1928 of the Social Security Act.
Funding from the federal VFC program is supplemented with federal 317
funds that allow the federal purchase of vaccines and State General Revenue
funds to support TVFC and all immunization activities across Texas.
Section 317 of the Public Health Service Act authorizes the federal purchase
of vaccines to vaccinate children, adolescents and adults.
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Section 317 discretionary funding also supports immunization program
operations at the local, state and national levels.
TVFC enables more than 4.3 million Texas children to have access to
immunizations. This is accomplished through a network of support provided
by DSHS and with assistance from DSHS Public Health Regions (PHRs) and
contracted Local Health Departments (LHDs). These organizations function
as Responsible Entities (RE) to ensure compliance with state and federal
standards and the effectiveness of vaccine distribution. As a TVFC- or
ASN-enrolled site, you will contact your RE for more information and details
about required vaccine reporting.
III. Vision and Mission of the DSHS Immunization
Program
Vision
To create a Texas free of vaccine-preventable diseases.
Mission
To remove barriers to complete and timely vaccination, increase vaccine
coverage levels and reduce the burden of vaccine-preventable diseases for
all Texas infants, children, adolescents and adults.
IV. Goals of the DSHS Immunization Program
• Raise and sustain vaccine coverage levels for infants and children
• Improve adolescent vaccine coverage levels
• Improve adult vaccine coverage levels
• Prevent and reduce cases of vaccine-preventable diseases
• Maintain and improve public health preparedness
• Promote and practice the safe handling of vaccines and ensure the
accountability of all program components
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V. Goals of the TVFC Program
• Eliminate vaccine cost as a barrier to immunizations.
• Reduce the need for referrals by private clinics to public clinics by keeping
children in their “medical home” for comprehensive health care.
• Provide a vaccine delivery system that is both efficient and effective for
public and private enrolled sites.
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CHAPTER 1: TVFC SITE ELIGIBILITY AND ENROLLMENT
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CHAPTER 1: TVFC SITE ELIGIBILITY
AND ENROLLMENT
I. Signing Clinician Eligibility Requirements
To be eligible to enroll in the TVFC program, signing clinicians must be one
of the following:
• Medical Doctor (MD)
• Doctor of Osteopathy (DO)
• Nurse Practitioner (NP)
• Certified Nurse Midwife (CNM)
• Physician Assistant (PA)
• Registered Pharmacist (RPh)
The following types of organizations are eligible to participate in the
TVFC program:
• Behavioral Health Clinic
• Birthing Hospital or Birthing Center
• Community Vaccinator (non-health department)
• Correctional Facility
• DSHS Public Health Department Clinic
• DSHS Public Health Department clinic as agent for FQHC/RHC-deputized
• Emergency Medical Services (EMS) Facility
• Family Planning Clinic (non-health department)
NOTE:
Eligible signing clinicians
• MD
• DO
• NP
• CNM
• PA
• RPh
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• Federally Qualified Health Center (FQHC)
• Harris Health System
• HHSC Family Planning Clinic
• Hospital
• Indian Health Service, Tribal, or Urban Clinic
• Juvenile Detention Center
• Local Health Department (LHD)
• Local Health Department (LHD) as agent for FQHC/RHC-deputized
• Migrant Health Center
• Mobile Provider
• Pharmacy
• Private Practice
• Refugee Health Clinic
• Residential/Congregate Care Facility
• Retail Health Clinic
• Rural Health Clinic (RHC)
• School-Based Clinic (permanent clinic location)
• State Hospital
• STD/HIV Clinic (non-health department)
• Student Health Services
• Teen Health Center (non-health department)
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• University Health System
• Urgent/Immediate Care Center
• Women, Infant and Children (WIC) Clinic
• Other
II. Enrollment Requirements
A. Specific Terms of Agreement
To participate in the TVFC program, each signing clinician must agree to
follow all program requirements. By signing the TVFC program agreement,
the office and all practitioners associated with the medical site agree to:
• Submit a profile representing populations served by the facility annually.
• Screen for and document TVFC-eligibility of all children at each
immunization encounter.
• Administer TVFC program vaccines to all children 18 years of age or
younger who meet the established eligibility criteria.
• Comply with appropriate vaccination schedules, dosages and
contraindications that are established by the Advisory Committee on
Immunization Practices (ACIP).
• Maintain all records related to the TVFC program for at least five years
and, upon request, make these records available for review.
• Immunize eligible children with publicly supplied vaccines at no charge to
the patient for the vaccine.
• Not charge an administration fee above $13.75 per vaccine dose.
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• Not charge an administration fee to Medicaid or Children’s Health
Insurance Program (CHIP) patients.
• Not deny administration of a TVFC program vaccine to an eligible child
because of the inability of the child’s parent or guardian to pay the
administration fee.
• Not send a patient to collections or charge additional fees for
non-payment of a TVFC program administration fee.
• Provide a copy of the most current Vaccine Information Statements (VIS)
for each vaccine at the time of administration.
• Comply with the TVFC program requirements for vaccine management,
including ordering and proper storage and handling practices.
• Not be cited or terminated from Medicaid or CHIP.
• Operate within the TVFC program in a manner intended to avoid fraud
and abuse.
• Participate in TVFC program compliance site visits, including unannounced
visits and other educational opportunities, as required.
• Acknowledge that the DSHS Immunization program may terminate the
agreement at any time for failure to comply with established
requirements. If the agreement is terminated, the office and/or facility
agrees to return all TVFC program vaccines.
In jurisdictions where there are mass vaccinators enrolled or circumstances
where the enrolled provider is not providing direct services and other parties
are involved with administering the vaccines, all parties involved with
implementing the clinics, including the signing clinician and other groups
who are directly administering the vaccine, must sign an agreement. There
must be a written agreement attached to the TVFC program agreement
detailing the responsibilities of each party involved.
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B. Site Coordinator Responsibilities
The TVFC/ASN programs require the signing clinician to designate a primary
vaccine coordinator at the site who will ensure all vaccines are stored and
handled correctly. It is also required that a second staff member (backup
vaccine coordinator) at the facility be named to serve as the alternate in the
absence of the primary coordinator. Both coordinators must be physically
located at the clinic site and fully trained in routine and emergency policies
and procedures.
Each site must have a unique primary vaccine coordinator and backup
vaccine coordinator. It is required that both vaccine coordinators provide a
unique email address for user security and contact purposes. TVFC/ASN sites
with operating hours or operating days that do not overlap may share
coordinators.
The primary and backup vaccine coordinators must do the following to
implement, oversee and monitor the TVFC and/or ASN program
requirements.
• Ensure only eligible patients receive TVFC/ASN program vaccines.
• Set up data loggers in storage units.
• Ensure staff are familiar with the operations of the data loggers, including
how to download the data (recommended weekly, on Mondays).
• Monitor and record the temperatures of units (refrigerator and freezer)
two times each workday.
• Read and record the minimum and the maximum temperatures at the
beginning of each workday.
• Reset the minimum and maximum temperatures at the end of
each workday.
• Monitor the operation of storage equipment and systems.
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• Maintain all documentation, such as vaccine inventory and
temperature logs.
• Document TVFC/ASN program vaccine inventory information.
• Place orders for additional TVFC/ASN program vaccines in the Vaccine
Allocation and Ordering System (VAOS).
• Report vaccine activities monthly in VAOS.
• Track and document doses administered.
• Oversee proper receipt and storage of vaccines deliveries.
• Organize vaccines to monitor expiration dates.
• Remove expired vaccine from storage units and document the loss.
• Ensure vaccine is stored and handled appropriately to safeguard
vaccine viability.
• Review and analyze temperature data at least weekly to identify shifts in
temperature trends.
• Respond to out-of-range temperature excursions or respond in the event
of an emergency (unit failure, power outage, disaster, etc.).
• Oversee proper vaccine transport when necessary (i.e., during
an emergency).
• Ensure other staff are trained in properly storing and handling vaccines.
• Notify RE of staff changes (primary, backup vaccine coordinators, or
signing clinician).
In the event a primary or backup vaccine coordinator is removed from a
site, providers must notify their RE of the staffing update immediately.
Once the notification is received, the site will have 10 business days to
designate and onboard a replacement coordinator. If a new coordinator is
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not onboarded (including the completion of all required trainings) at the
end of the 10th business day, the site will be suspended until a new
coordinator is designated.
C. Initial Enrollment
The first step in joining the TVFC or ASN program is to complete the
TVFC/ASN programs agreement. If you need assistance, you should contact
your RE or the DSHS Immunization program at the phone number listed on
the agreement form. The TVFC/ASN programs agreement is available on the
DSHS Immunization program website at
www.dshs.texas.gov/immunize/tvfc/info-for-providers.aspx.
The TVFC/ASN programs agreement must be updated and completed each
year. The agreement includes basic information about the facility and
outlines the signing clinician’s responsibilities. The signed agreement must
be received and processed by the TVFC
program before the clinic receives state and
federally funded vaccines.
All licensed health care staff (MD, DO, NP, CNM,
PA, or RPh) at the facility who have prescribing
authority must be listed on the TVFC/ASN
program agreement form. The listing must also
include the signing clinician’s information.
Information required for all licensed health care staff include the following:
• Name
• Title
• Texas Medical/Nursing/Pharmacy License Number and
• National Provider Identification (NPI)
If the signing clinician leaves the practice, the program “Provider
Agreement” must be updated and signed by a new signing clinician.
NOTE:
If the signing clinician
leaves the practice,
the Program Provider
Agreement must be
updated and signed by
a new signing clinician.
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The profile section of the TVFC/ASN programs agreement requests
information about the site’s patient population, which includes the projection
and identification of clients the clinic will serve in the upcoming year.
New sites must provide accurate data from the previous 12 months and
must also include the number of insured patients served by the site.
These numbers must be specific to the clinic site and not combined with
other clinics’ patient numbers. Data sources may come from the following:
• Immunization registry
• Benchmarking
• Number of Medicaid Claims or other billing data, or
• Client encounter data
The RE will assist the staff through the enrollment process. Two staff
members at each site must be designated as primary and backup vaccine
coordinators. The two staff members will be educated by the RE on how to
complete the two required CDC “You Call the Shots” training modules, the
most current TVFC/ASN “Provider Policy Training” module and “Vaccine
Allocation and Ordering System (VAOS) Training” upon initial enrollment.
After completing the modules, the “Certificates of Completion” must be
electronically uploaded to the TVFC program enrollment system, Syntropi.
The RE will provide education by conducting an initial enrollment visit with
the primary and backup vaccine coordinators.
To participate in the TVFC program, sites must enroll in and report to the
Texas Immunization Registry (ImmTrac2). Texas Health and Safety Code
161.007-161.009 requires all medical providers to report all immunizations
administered to clients who are 17 years of age and younger to ImmTrac2
within 30 days of administration. The RE will provide necessary education on
ImmTrac2.
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The RE will submit required paperwork to the DSHS Immunization program.
The DSHS Immunization program checks the Office of the Inspector
General’s (OIG) “List of Excluded Individuals or Entities” to ensure that all
licensed health care professionals listed on an enrollment form are eligible to
participate in the TVFC/ASN programs.
Once the forms are approved by the DSHS Immunization program, a
Provider Identification Number (PIN) is issued. The PIN will be the clinic’s
vaccine account number for the duration of the clinic’s enrollment in the
TVFC/ASN programs.
The PIN is required to be included on all TVFC/ASN program forms and
communications. Sites must enter their TVFC/ASN PIN into their ImmTrac2
organization account.
Information regarding ImmTrac2 may be found in Chapter 7: Documentation
Requirements and on the ImmTrac2 webpage. The enrolled site will be
contacted by the RE to schedule additional visits/contacts.
D. TVFC/ASN Enrollment Visit
All new sites to the TVFC/ASN programs must receive an enrollment visit
prior to receiving vaccines. When the RE visits the new site, a review of all
storage units is performed to ensure adequate and approved storage units
are being used. A certified and calibrated data logger must be in all units
that store TVFC/ASN program vaccine and temperatures must be
documented twice daily for seven operational days before any TVFC/ASN
program vaccine is received. A training for new clinics is conducted on
TVFC/ASN programs policies to ensure they are understood and followed.
The initial enrollment visit typically takes a minimum of three hours. The
primary and backup vaccine coordinator must both be available to meet with
the RE for the duration of the initial enrollment visit.
Information for new sites is available at
https://www.dshs.texas.gov/immunize/tvfc/info-for-providers.aspx.
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Training for new sites will include the following:
• Review and confirmation that the staff understand and will implement all
TVFC/ASN program requirements.
• Confirmation of the following:
• Proper equipment is available to store TVFC/ASN program vaccine
• Staff understands how to properly store, handle and monitor TVFC/ASN
program vaccine and
• Staff knows who to contact if problems arise
• Verification of the following:
• Facility information provided on the initial enrollment form to include:
• Shipping address
• Phone numbers
• Email address of signing clinician (must not exceed 40 characters)
• Medical license numbers and NPI of all listed licensed health care
professionals
• A primary and backup vaccine coordinator have been identified.
• A plan for routine and emergency vaccine management is in place.
• There are adequate water bottles in the refrigerator and frozen water
bottles in the freezer.
• Vaccine storage units have enough storage space to accommodate the
maximum capacity of vaccine, especially during back-to-school or flu
season.
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• Review the following forms:
• Vaccine choice and
• Vaccine management plan
• Training also includes a review of the following:
• “TVFC/ASN program Provider Manual,” stock no. 11-13602
• Vaccine ordering and accounting in VAOS
• Proper vaccine storage and handling
• “Vaccine Quarantine Bag”
• Immunization guidelines and schedules
• Texas school and daycare requirements
• Texas’ Immunization Registry, ImmTrac2
• Forms and literature
• Vaccine Information Statements (VIS)
• Vaccine Adverse Events Reporting System (VAERS)
• Vaccine safety and other resources
• “Standards for Pediatric Immunization Practices,” stock no. 6-251
• “Standards for Adult Immunization Practice,” stock no. 6-252 (for
providers who also participate in ASN)
• Vaccine types
• Administering vaccines
• Schedule and intervals of vaccines
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• Anatomic site
• Needle sizes and
• “Contraindications and Precautions to Vaccines for Children and Adults”
poster, stock no. 6-61
E. TVFC/ASN Site Set-up
Once temperature charts are logged twice daily for seven operational days
and temperatures are within the required range, the RE begins the
TVFC/ASN program site set-up process and performs the following activities
to ensure that vaccines are stored and handled appropriately:
• Checks the equipment to include the following:
• Placement of data loggers, probes and calibration certificates
• Verifies placement of or installs plug guards
• Trains the staff on these essential processes:
• Vaccine choice options
• Establishing maximum stock levels (MSL)
• Online vaccine management in VAOS
• Setting up an initial order
• Completion of a vaccine management plan
• Completion of a temperature recording form
• Checks to ensure the following signage is displayed prominently within
the clinic.
• “VACCINE MANAGEMENT - Recommendations for Storage and Handling
of Selected Biologicals” poster, stock no. 6-26P (if available)
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• “How to Administer Vaccinations” (Anatomic Sites for Immunizations)
poster, stock no. 6-27P
• “Contraindications and Precautions to Vaccines for Children and Adults”
poster, stock no. 6-61
• “Giving All the Doses” Chart, stock no. 11-12155
• “Refrigerator Warning Signs,” stock no. 6-180
• “Do Not Unplug” stickers on wall outlet and at the circuit breaker,
included in the “Refrigerator Warning Signs,” stock no. 6-180
• Provides immunization schedules, catch-up schedules, resource lists and
other materials.
If any of the items above were not provided to you as a new TVFC/ASN-
enrolled site, contact your RE.
F. Vaccine Accountability
Vaccine accountability is a cornerstone of the TVFC/ASN programs and
one of the highest priorities for the DSHS Immunization program.
When a site enrolls in the programs, the staff agree to the accountability
requirements as a condition of participation. All TVFC/ASN-enrolled sites
must ensure the following:
• TVFC/ASN program vaccines are administered only to eligible clients.
• Vaccine loss and waste are minimized and documented.
• Fraud and abuse (as defined in Chapter 6: Fraud and Abuse) does
not occur.
• TVFC/ASN program vaccine inventory is accurately reported monthly.
• Patients are screened at all immunization encounters for TVFC/ASN
program eligibility.
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G. Provider Identification Number
A PIN is assigned to new sites upon initial enrollment into the TVFC/ASN
programs. The PIN is the clinic’s vaccine account number for the duration of
the clinic’s enrollment in the TVFC/ASN programs.
The PIN is required to be included on all TVFC/ASN program forms and
communications. PINs are associated with site visits, vaccine ordering,
vaccine shipments and for overall program operations. As a result, separate
PINs will be created for sites in different physical locations, even if they are
supported by the same clinic staff.
The TVFC/ASN program PIN must be entered in the site’s ImmTrac2 user
account. Information regarding ImmTrac2 may be found in Chapter 7:
Documentation Requirements and on the ImmTrac2 website.
H. Provider Change of Information
Staff at enrolled sites are responsible for notifying their RE when there are
changes to site information. To notify an RE, staff should fill out a “Changes
to Enrollment Form,” stock no. 11-15224, when the following changes occur:
• Facility name (Complete sections A and B)
• Facility shipping address (Complete sections A and C)
• Facility shipping hours (Complete sections A and D)
• Signing clinician (Complete sections A and E)
• Prescribing authorities (Complete sections A and F)
• Patient population data change (Complete sections A and G)
• Primary and/or backup vaccine coordinator (Complete sections A and H
and submit required training documents)
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The completed form must be sent to the RE via email. If there is a change in
primary and/or backup vaccine coordinator(s), also attach the following
training certificates for the coordinators being updated:
• The CDC's "You Call the Shots" Modules 10 and 16
• The most current TVFC/ASN “Provider Policy Training”
• The “Vaccine Allocation and Ordering System (VAOS) Training”
Depending on the changes indicated on the form, the DSHS Immunization
program may have site staff complete additional steps.
Failure to properly update current clinic information may result in vaccine
delays and possible negligent vaccine loss.
I. Annual Re-Enrollment
TVFC/ASN program re-enrollment takes place in October, to prepare for the
following year. The TVFC/ASN programs require that the TVFC/ASN
programs agreement and profile be updated annually as these forms are
required for continued enrollment in the TVFC/ASN programs. TVFC/ASN-
enrolled sites that are a Federally Qualified Health Center (FQHC) or a Rural
Health Clinic (RHC) must also submit a copy of the Centers for Medicare and
Medicaid Services (CMS) letter designating the sites as such.
The assigned primary and backup vaccine coordinators are required to
complete the most current TVFC/ASN “Provider Policy Training” module and
an online re-enrollment form each year. The two CDC “You Call the Shots”
training modules and VAOS training are also required during re-enrollment.
Certificates of Completion for the most current TVFC/ASN “Provider Policy
Training” module for the primary and backup vaccine coordinator must be
uploaded electronically as part of the re-enrollment process.
Clinics are required to be enrolled in ImmTrac2 to re-enroll into the
TVFC/ASN programs. Staff that do not know their ImmTrac2 organization
code should contact their RE for assistance. Information regarding ImmTrac2
may be found in Chapter 7: Documentation Requirements, II. The Texas
Immunization Registry (ImmTrac2) and on the ImmTrac2 webpage.
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Sites that fail to complete re-enrollment cannot continue participation in the
program for the upcoming year. All sites that do not have a completed re-
enrollment on file by the deadline will be subject to withdrawal and must
complete a new enrollment to participate in the program for the upcoming
year following all approving processes. Vaccine shipments may be
interrupted for sites without current enrollment information on file.
NOTE: For sites that are also enrolled in ASN, the TVFC and ASN re-
enrollment forms have been combined into a single re-enrollment form.
J. Deputization of Clinics
Deputization is used to support areas where an FQHC/RHC is unable to serve
an Underinsured population. If an FQHC/RHC is unable to serve a specified
population, then DSHS PHRs and LHDs are the second line to serve as a
"safety net" for the Underinsured. Texas has implemented deputization of
public health department clinics and LHDs. Delegation of Authority (DOA) or
deputization, allows Texas FQHCs and RHCs to delegate authority to DSHS
PHRs and LHDs to vaccinate Underinsured children. With few exceptions, all
PHR and LHD clinics must be enrolled in TVFC and ASN programs.
Underinsured children served in FQHC, RHC, or deputized sites are eligible
for the federal VFC vaccine according to federal guidance.
III. Withdrawal from TVFC/ASN
The RE must be contacted if a TVFC/ASN-enrolled site wants to withdraw
from the TVFC/ASN programs. Prior to withdrawal, clinic staff completes a
Withdrawal Form, stock no. F11-11443 and submit it to the RE.
The RE will arrange to pick up TVFC/ASN program vaccine and will assist
with final paperwork. When withdrawing providers from the TVFC/ASN
programs, Responsible Entities (RE) will collect state-issued data loggers and
state vaccines from withdrawing providers.
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IV. Suspension from TVFC/ASN Programs
If it is determined that the TVFC/ASN programs’ agreement or accountability
requirements have been violated, the enrolled site may temporarily lose
program privileges. Suspension is dependent upon the severity of the non-
compliance issues and/or failure to complete the TVFC/ASN program
required corrective action plans.
TVFC/ASN program corrective action plans are set in place to correct failures
in vaccine management and non-compliance issues, including, but not
limited to:
• Failure to complete re-enrollment in a timely manner
• Failure in vaccine management
• Failure of required patient eligibility screening
• Improper storage and handling practices
• Failure to complete monthly reporting requirements.
Staff at suspended sites may be required to complete additional training as
part of a corrective action plan.
V. Termination from TVFC/ASN
A site may be terminated from the TVFC/ASN programs for continued non-
compliance with TVFC/ASN program requirements, such as failure to
complete required corrective actions associated with non-compliance. An
enrolled TVFC/ASN programs provider that has not ordered vaccines in the
past 12 months may be terminated. A site may also be terminated for
instances of fraud and abuse, as described in Chapter 6: Fraud and Abuse,
of this manual.
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All sites will be notified of termination from the program via a signed letter
from the Immunization program Director. Terminated sites will be removed
from the TVFC/ASN programs for a period of at least one year. After the
minimum termination period, sites seeking re-enrollment must seek
approval to re-enroll from the DSHS Immunization program.
VI. Re-enrollment after Termination
In the event a terminated site is approved for re-enrollment in the
TVFC/ASN programs, completion of the most current TVFC/ASN “Provider
Policy Training” is required. Staff must participate in on-site education and
confirm that any outstanding issues have been resolved through a focused
site review and assessment.
Sites terminated for instances of fraud and abuse may be considered for
re-enrollment after year and only if the signing clinician is actively enrolled
in Medicaid at that time and is not listed on OIG’s “List of Excluded
Individuals and Entities (LEIE)”.
The DSHS Immunization program has the authority to determine whether a
site is eligible to re-enroll in the TVFC/ASN programs.
CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING
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CHAPTER 2: TVFC PATIENT ELIGIBILITY
AND SCREENING
I. Patient Eligibility Requirements
A. TVFC Patient Eligibility Criteria
Any child who is 18 years of age or younger and meets at least one of the
eligibility criteria listed below is eligible to receive TVFC program vaccine:
• Enrolled in Medicaid or is Medicaid-eligible
• Is Uninsured
• Is an American Indian or Alaskan Native (in accordance with 25 USC 1603).
• Is Underinsured:
• A child who has commercial (private) health insurance, but coverage
does not include vaccines
• A child whose insurance covers only selected vaccines (TVFC-eligible
for non-covered vaccines only), or
• A child who has health insurance covering all vaccines, but the plan
has a fixed dollar limit or cap on the amount that it will cover for
vaccines (TVFC-eligible once fixed dollar amount or cap is reached)
• Enrolled in CHIP.
Insured children who have Medicaid as their secondary insurance
(Medicaid-eligible) are eligible for TVFC program vaccine and must not be
refused vaccine administration due to their insurance status.
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The Texas Department of Insurance (TDI) defines health insurance as a
contract that requires a health insurance company to pay some, or all the
health care costs in exchange for a premium. A patient may be considered
uninsured or (for the purpose of the TVFC eligibility) if they have one of the
following types of “other” health insurance:
• Short-term major medical
• Limited benefit health insurance
• Supplemental health insurance
• Health care sharing ministries (HCSM)
• Direct primary care
To determine if an insurance plan is covered by the State of Texas, visit the
TDI webpage at https://www.tdi.texas.gov/index.html.
If a child is TVFC-eligible in more than one eligibility category, select and
document the eligibility category that will require the least out-of-pocket
expense for the parent or guardian.
Immigration and/or residency status does not affect a child’s eligibility for
the TVFC program.
B. Children’s Health Insurance Program (CHIP)
Texas has an insurance program called the Children’s Health Insurance
Program (CHIP). An agreement between the DSHS Immunization program
and CHIP stipulates vaccines for eligible CHIP enrollees are purchased
through the federal contract.
Since children with CHIP are not eligible for the federal VFC program, the
DSHS Immunization program is reimbursed for doses administered to CHIP
children based on CHIP enrollment data. TVFC program sites that administer
vaccines to CHIP children must actively participate in CHIP. If CHIP is not
billed for administration fees by the staff at the site, CHIP children must not
be vaccinated.
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C. Medicaid as Secondary Insurance
Children with private health insurance and Medicaid as a secondary
insurance are eligible for the TVFC program. Medicaid can be billed for the
administration fee. The parent or guardian of a child with Medicaid as
secondary insurance should never be billed a vaccine administration fee.
D. Nineteen-Year-Olds
Patients who are 19 years of age and who previously initiated a vaccination
series under the TVFC program, but have not completed the series, may
complete the series using ASN program vaccines regardless of their current
health insurance status. The vaccine must be administered at a DSHS PHR
or LHD clinic. This provision only applies to patients that have not yet
reached their 20th birthday.
NOTE: A “series” in this case is specific to two doses of Hepatitis A (HepA);
three doses of Hepatitis B (HepB); two doses of Meningococcal Conjugate
(ACWY); two doses of Measles, Mumps and Rubella (MMR); and three doses
of Tetanus, Diphtheria/Tetanus, Diphtheria, Pertussis (Td/Tdap).
This policy does not apply to Meningococcal B (MenB), Polio, Haemophilus
influenzae type b (Hib), or Influenza (Flu) vaccines. This policy also does not
apply to booster doses.
II. Patient Eligibility Screening Record
Screening for patient eligibility is the foundation of the TVFC program
accountability. Screening all children at every immunization encounter and
documenting eligibility screening at every visit is the only way to ensure that
TVFC program vaccine is used only for TVFC-eligible children. As such, full
compliance on screening for eligibility is required. In the event improper
screening results in the administration of TVFC program vaccine to a
non-TVFC-eligible child, staff are responsible for documenting the error on a
“Vaccine Borrowing Form,” stock no. EF11-14171 and immediately replacing
the improperly used TVFC program vaccine with private stock.
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Eligibility documentation of each child receiving TVFC program vaccine at
every visit is required. During a child’s initial visit, eligibility must be
documented per the TVFC program guidelines. Every subsequent visit must
contain the child’s eligibility information.
The “Patient Eligibility Screening Record,” stock no. C-10, may be used, or
staff may electronically store patient demographic information in the site’s
Electronic Medical Record (EMR). Eligibility screening must be
completed/ updated for all children at every visit, even including children
with a previous record on file. A child’s eligibility must be documented at
every visit prior to vaccine administration. The screening form must be
completed by the parent, guardian, individual of record, or by a health care
provider and is a self-declaration. Verification of the parent’s/guardian’s
response is not required.
Eligibility screening must include all the following elements:
• Date of screening
• Child’s name
• Child’s date of birth
• Parent/guardian’s name
• Clinic name and
• Eligibility status for each visit
Eligibility screening records must be
kept on file with the patient’s record,
for a minimum of five years after the
last date of service to the patient and
must be easily retrievable.
It is also acceptable for sites to utilize an EMR system to capture and save
the information from the patient eligibility screening record if the EMR
captures all the required eligibility elements.
NOTE:
Screening patient eligibility is
the foundation of TVFC
program accountability.
Screening must be completed
for all children at every visit.
Verification of the parent or
guardian response is not
required.
CHAPTER 3: VACCINE MANAGEMENT
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CHAPTER 3: VACCINE MANAGEMENT
I. Approved Vaccines
All vaccines and toxoids recommended by Advisory Committee on
Immunization Practices (ACIP) are available from the TVFC program to
enrolled clinic sites.
• Coronavirus (COVID-19)
• Diphtheria-Tetanus toxoids and acellular Pertussis (DTaP)
• Diphtheria-Tetanus toxoids and acellular Pertussis, Hepatitis B and
inactivated polio (DTaP-Hep B-IPV)
• Diphtheria-Tetanus toxoids and acellular Pertussis, inactivated polio and
Haemophilus influenzae type b (DTaP-IPV/Hib)
• Diphtheria, tetanus
• Pertussis, Polio, Haemophilus influenzae type b and Hepatitis B
(DTaP-IPV-Hib-Hep B)
• Diphtheria-Tetanus toxoids and acellular Pertussis and inactivated polio
(DTaP-IPV)
• Hepatitis A (Hep A)
• Hepatitis B (Hep B)
• Hepatitis A and Hepatitis B (Hep A-Hep B) combination
• Haemophilus influenzae type b (Hib)
• Human Papillomavirus (HPV)
• Influenza (Flu)
• Inactivated polio (IPV)
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• Measles, Mumps and Rubella (MMR)
• Measles, Mumps, Rubella and Varicella (MMRV)
• Meningococcal groups C and Y and Haemophilus influenzae type b
(tetanus toxoid) (HIBMENCY)
• Meningococcal conjugate (MCV4)
• Meningococcal Serogroup B (MenB)
• Pneumococcal Polysaccharide 23-valent vaccine (PPSV23)
• Rotavirus (RV)
• Respiratory Syncytial Virus (RSV)
• Tetanus and Diphtheria toxoids, adsorbed (Td)
• Tetanus and Diphtheria toxoids and acellular Pertussis (Tdap)
• Varicella
II. Vaccine Ordering
A. Vaccine Choice
All vaccines and toxoids recommended by the ACIP are available from the
TVFC program to enrolled clinic sites. Clinics participating in the TVFC
program are required to offer all ACIP-recommended vaccines to the eligible
populations they serve, including flu vaccine. House Bill 448 from
the 81st Texas Legislature gives staff at TVFC/ASN-enrolled sites the
opportunity to choose preferred brands and presentations of vaccines from
available formularies.
The signing clinician at TVFC/ASN-enrolled sites may choose vaccine brands
and presentations. For new clinics enrolling in the TVFC/ASN programs, the
RE and the staff will have the opportunity to choose their desired vaccine
brands and presentations in VAOS.
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Changes or adjustments to specific vaccine brands and presentations within
each vaccine “family” (i.e., DTaP) can be made, or sites can decide to take no
action which will maintain the current selections. Staff at TVFC/ASN-enrolled
sites are encouraged to review all choice selections as needed.
A site’s primary or backup vaccine coordinator may complete the process,
however, the signing authority must be consulted and must agree to the
vaccine choices.
Only vaccines supplied by the CDC to the TVFC/ASN programs will be
available for vaccine choice.
If a chosen vaccine is not available, the TVFC/ASN programs have the
authority to replace the unavailable vaccine with a comparable substitution
until the chosen vaccine becomes available.
NOTE: Vaccine choice does not apply in the event of a disaster or public
health emergency, terrorist attack, hostile military or paramilitary actions, or
any other extraordinary law enforcement emergency.
B. Patient Population Profile Estimates
The patient profile captures the number of Federal VFC- and TVFC-eligible
children served in each facility. Information reported on the patient profile
must represent the populations served during the most recent 12 months.
During initial enrollment and annual re-enrollment, DSHS requires all
enrolled sites complete the patient profile.
This data is used to ensure that vaccine orders are in the appropriate
amounts and that each site properly maintains their vaccine inventories.
The patient population data is utilized during the first year of a site's TVFC
program participation to calculate Maximum Stock Levels (MSLs) to establish
suggested order quantities. This data should be collected by using one or a
combination of any of the following sources:
• Benchmarking – Process whereby providers maintain logs in which
they record all vaccines administered by type and number of doses and
by patient VFC program eligibility category over a predetermined period,
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e.g., one to three months. This data is used to establish projections of
vaccine needs over a 12-month period and assess the appropriateness of
vaccine orders placed.
• Medicaid Claims – Medicaid billing data reflecting the services provided to
Medicaid-enrolled patients. Data collected using this method should be
deduplicated.
• Immunization Information System/Registry Data – Data submitted to
ImmTrac2, a secure and confidential database that safely consolidates and
stores immunization records from multiple sources in one centralized system.
• Doses Administered – Data collected each time vaccine doses are
administered for patients. Data collected using this method should be
deduplicated.
• Encounter data – Data that counts each individual patient encounter
once. This data is deduplicated from the total number of patient visits for
each individual patient.
• Billing System – The site’s method of billing patients for services.
Data collected using this method should be deduplicated.
• Other Methods (including forecasting) – Any method not listed above,
including future predictions based on current patient populations.
When there is a change in the population, the “Changes to Enrollment Form,”
stock no. 11-15224, must be submitted to the RE. REs will ensure the form is
routed to the DSHS Immunization program.
To assist providers with the management of their vaccine inventories,
MSL are calculated. MSL is a calculated peak dose inventory (per vaccine
type) and provides a suggested quantity of the maximum number of doses a
site needs to maintain a 75-day inventory.
Changes to the patient profile data will impact MSLs.
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C. Vaccine Inventory Plan and Maximum Stock Levels
The vaccine inventory plan requires all enrolled sites to maintain a 75-day
supply of vaccine inventory. Staff at TVFC/ASN-enrolled sites should place
vaccine orders monthly. DSHS recommends placing a vaccine order when
there is a four-week supply of vaccine available at the site, to ensure there
is enough vaccine in stock to allow for any potential delays.
DSHS also recommends smaller, more frequent orders rather than larger
orders to minimize the amount of vaccine loss if an incident occurs during
shipment or in the vaccine storage unit. Additional orders may be placed
during the month.
Although vaccine orders are not required each month, it is best practice for
providers to place an order frequently enough to maintain a 75-day supply
of vaccine.
Current inventory and unit storage capacity must be considered when
vaccine orders are placed to ensure adequate storage for all vaccines
is available.
Special circumstances may allow for monthly MSL adjustments on
rare occasions. Staff at TVFC/ASN-enrolled sites must request a review
and obtain permission from their RE prior to ordering more than their
suggested MSL quantity.
Upon initial enrollment, MSLs are calculated based on the patient population
reported during enrollment. All MSLs are monitored and can be revised by
adjusting the patient profile in Syntropi. Newly enrolled sites may have MSLs
reassessed by the RE after six months with the TVFC/ASN programs.
MSLs are recalculated monthly based on the previous six months of doses
administered data.
The monthly average MSL is determined from this data.
Staff at TVFC/ASN- enrolled sites may not order vaccine more than their
suggested quantity without permission from the RE.
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See Section VIII. Reporting Requirements, for more details of the monthly
reporting requirements.
D. Increasing and Decreasing Maximum Stock Levels
MSLs may be increased or decreased at any time if the number of
TVFC/ASN-eligible patients changes, or if there are any applicable changes
to the status of the facility that might impact vaccine usage.
Staff at TVFC/ASN-enrolled sites must notify the RE if a change is needed.
Changes may also be made by the DSHS Immunization program based upon
the data gathered during the calendar year.
To determine appropriate MSLs for the back-to-school season, calculations
are done automatically in VAOS using doses administered data from the
previous June, July, August and September.
MSLs may be lowered at sites that consistently order below the suggested
quantity. MSLs may be increased at sites that place multiple orders during a
given month. Final determination is made depending on the frequency and
duration of the ordering patterns.
E. Short-Dated Vaccine
Short-dated vaccines are those that are within 60 to 90 days of expiration.
Placing vaccine orders according to the established MSLs and rotating
vaccines so that short-dated vaccines are used first will help to prevent
losses due to expiration. Clinic staff must note vaccine expiration dates when
physically counting inventory at the
end of the month. Short-dated
vaccine must be used first. Vaccine
surplus kept in inventory increases
the risk of vaccine expiration and
increases the amount of loss in the
event of unit failure. When vaccines
are ordered, staff must have no more
than the designated MSL in stock,
including the order.
NOTE:
Monthly reporting in VAOS is
required for all TVFC/ASN
program enrolled sites between
the first and seventh of each
month, whether a vaccine order
is placed or not.
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Each site is required to notify the RE 60 to 90 days prior to the expiration
of vaccine. If the vaccine is not able to be administered prior to expiration,
the RE may assist with moving the vaccine to another site, provided another
site is willing to accept the vaccine.
Vaccine diluents, the liquid mixed with a freeze-dried vaccine to reconstitute,
must be managed in the same manner as vaccines. The expiration date of
diluents must be checked prior to every reconstitution. The diluent must be
rotated to use the shortest expiration date first.
If vaccines expire, they are considered non-viable. Expired vaccines must be
placed in a “Vaccine Quarantine Bag,” clearly labeled “Do Not Use” and
removed from storage units.
F. Storage Capacity for Vaccine Orders
Sites must have adequate refrigeration and/or freezer space to
accommodate a maximum order based on MSLs, including flu and
back-to-school. Space needed for private stock vaccine must be taken into
consideration when calculating storage capacity.
G. Vaccine Ordering in the Vaccine Allocation and Ordering
System (VAOS)
The TVFC/ASN programs use VAOS for vaccine ordering. VAOS allows
TVFC/ASN-enrolled sites to manage vaccine inventory online. All vaccine
orders will be placed in VAOS unless internet access is unavailable.
Sites may be held responsible for vaccine loss that is a result of erroneous
information entered into VAOS.
Prior to placing a vaccine order, the following information must be entered in
VAOS:
• Verification of days and hours of operation that the staff at the
TVFC/ASN-enrolled sites are available to receive vaccine
• Clinic’s delivery address
• Primary and backup vaccine coordinators contact information
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• “Temperature Logs”
• “Doses Administered”
• Physical inventory
• Receipt of vaccine shipments (if applicable)
• Vaccine transfers (if applicable)
• Vaccine loss (if applicable)
• If applicable, all doses that will expire within the next 60 to 90 days and
• All scheduled clinic closures (including holidays) must be noted in the
comments section of the order.
Monthly reporting in VAOS is required for all TVFC/ASN programs-enrolled
sites between the first and seventh of each month, whether a vaccine order
is placed or not. Additionally, monthly reporting is required each time an
order is placed.
All orders placed in VAOS will be reviewed and approved by the RE after the
completion and submission of the required monthly reporting and resolution
of outstanding issues. Incomplete or inaccurate online orders will be placed
on Hold pending corrections which may cause vaccine orders to be delayed.
Each site must abide by established MSLs when ordering vaccine. VAOS uses
the TVFC/ASN-enrolled site’s MSLs and current on-hand inventory to
determine a suggested quantity of vaccine on the “Place Order” tab.
Any order placed over the established MSL during a vaccine allocation, will
be reduced to the suggested quantity.
Vaccine loss is captured electronically in VAOS. When a loss of expired,
spoiled, or ruined/wasted vaccine is documented in VAOS, the system will
automatically place subsequent orders on Hold until the nature of the loss
has been determined.
All sites can view vaccine order status on the “Vaccine Requests” page of
VAOS. Status definitions are defined on the next page.
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If a discrepancy is found between the orders placed, the packing list, the fax
confirmation, or the doses received, staff at TVFC/ASN-enrolled sites must
immediately contact the RE for resolution. All vaccines must be appropriately
stored immediately upon receipt regardless of errors in the order.
H. Vaccine Ordering for Sites Without Internet Access
TVFC/ASN-enrolled sites without access to the internet must contact the RE.
The RE will enter the TVFC/ASN program vaccine order in VAOS.
The TVFC/ASN-enrolled site must submit the following paper forms to the RE
to place a vaccine order.
• “Monthly Biological Report,” stock no. C-33
• “Temperature Recording Forms,” stock no. EC-105
The monthly biological report is reviewed by the RE to ensure that the
beginning inventory matches the last month’s ending inventory.
APPROVED
Indicates the order is ready to be sent to the
distributor for shipment after the order is placed
and approved by the RE.
PENDING
Indicates the order has not been approved,
pending the review of a Vaccine Loss Report
(VLR), the need for additional documentation, or
other identified issues.
ON HOLD
Indicates the order has been placed on hold by
the RE, pending additional documentation or
other identified issues that must be addressed
before the order is approved.
SENT TO VTRCKS Indicates the order is with the distributor.
SHIPPED
Indicates the order is in transit or a transfer has
been conducted in VAOS.
RECEIVED Indicates the vaccine order has been received.
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Calculations must be correct and all corrections will be reported to the
staff at the TVFC/ASN-enrolled site, so the records can be corrected prior
to ordering.
I. Vaccine Ordering for Newly Enrolled TVFC/ASN Sites
Newly enrolled TVFC/ASN-enrolled sites are set up for vaccine ordering in
VAOS following completion of new provider training with the RE. The vaccine
order is placed by the site staff after receipt of VAOS login information and
assignment of a PIN as part of the second visit/contact. The RE will collect
and review “Temperature Recording Logs,” stock no. EC-105, prior to
assisting the staff with placing the initial vaccine order. Only the primary and
backup vaccine coordinators will have access to VAOS.
J. Ordering Influenza Vaccine
The ACIP recommends routine annual flu vaccination of all persons aged six
months and older. Additionally, as a member of the TVFC program, signing
clinicians have agreed to administer all ACIP-recommended vaccines to the
eligible population that are served.
The pre-book for flu vaccine is a
commitment by the TVFC-enrolled sites
to order doses for the upcoming flu
season. Annual flu vaccine orders are
typically pre-booked in the first quarter of
each calendar year.
If a site’s flu vaccine order exceeds the
reported number of eligible children
documented in the patient profile section
of the enrollment form, staff may be
contacted for an explanation. If a site sees TVFC-eligible children and does
not order flu vaccine for the upcoming season, they must complete a
separate section of the survey explaining why they are not ordering the
vaccine and should expect to receive a follow-up contact from the RE.
TVFC-enrolled sites are required to follow all ACIP recommendations,
including the administration of flu vaccine.
NOTE:
DSHS recognizes that TVFC
and privately purchased flu
vaccine may arrive at sites
at different times during the
flu season. Even if this
occurs, TVFC program
vaccine must not be used
on ineligible children.
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The TVFC program orders a limited quantity of additional doses to account
for new sites that enroll after the closing of the pre-book survey.
Other unforeseen situations that may occur between the pre-book and the
actual release of the vaccines to the TVFC program may also be considered
for first-round allocations. Flu vaccine will be allocated to TVFC-enrolled sites
when it is made available to Texas.
Sites wanting to add or reduce the original flu order must contact their RE.
When the pre-booked orders are filled entirely, all remaining flu vaccine will
be added to the VAOS system for open ordering by all sites. If there is an
additional need for flu vaccine in a site or area of the state, the TVFC
program will contact other sites in Texas for a possible vaccine transfer or
may place an additional order with the CDC.
DSHS recognizes that both TVFC/ASN-supplied and privately purchased flu
vaccines may arrive at sites at different times during the flu season. Even if
this occurs, the TVFC program does not allow TVFC program vaccine to be
borrowed to administer to non-TVFC-eligible clients.
III. Vaccine Distribution
A. Vaccine Distributors
The TVFC/ASN programs use two vaccine distribution centers.
• McKesson Specialty, a third-party distributor which ships most TVFC/ASN
program vaccines which are refrigerated.
• Merck, the manufacturer of frozen vaccines, which ships directly to
TVFC/ASN-enrolled sites.
B. Receiving Vaccine Orders
The TVFC/ASN programs require that vaccine shipments always be accepted
and never refused or returned without specific instructions from the RE or
the DSHS Immunization program.
The staff at TVFC/ASN-enrolled sites must ensure that the accurate clinic
address and delivery hours are entered in Syntropi.
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For sites to receive vaccine shipments, appropriate staff must be on-site and
available at least one day a week other than Monday and for at least four
consecutive hours from 8:00 a.m. to 5:00 p.m.
Each site establishes the hours available to accept vaccine shipments when
the initial vaccine order is submitted in VAOS.
The vaccine will be shipped so it will arrive when staff are available to accept
the vaccine. The TVFC/ASN-enrolled site staff may not change available
hours in Syntropi once an order is placed. The signing clinician is responsible
for incomplete or erroneous information entered in Syntropi which can result
in vaccine loss.
Sites can expect their approved orders
approximately two to three weeks after placing
the online order in VAOS. It is important to
recognize and store vaccine shipments
immediately upon receipt to ensure vaccine
viability. All staff at TVFC/ASN-enrolled sites are
required to train other clinic staff on what a
vaccine shipment looks like and must maintain a
completed vaccine management plan in place to
ensure the vaccine is stored quickly and
correctly upon arrival.
The following steps are required when a vaccine shipment arrives.
• Check vaccines against the packing list to verify all vaccines have
been received.
• Inspect the vaccines and check the temperature strip or other
temperature reading device.
• Ensure adequate amount of diluent is included for those vaccines which
require reconstitution (e.g., MMR, Varicella).
NOTE:
Vaccine is packed by
the manufacturer and
distributor using
qualified pack-outs
and containers that
have been tested to
maintain appropriate
temperatures.
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• Determine the length of time the vaccine was in transit by looking at
the ship date and time on the packing list or the transport tracking link
in VAOS.
• Immediately contact the RE when:
• The appropriate quantity and type of vaccine or diluent is not received
• Vaccines have been received in error, or
• Vaccines appear to be compromised
• Appropriately store all vaccines immediately upon receipt regardless of
any quantity, shipping, or transport errors.
• Check expiration dates and rotate stock to ensure short-dated vaccines
are used first.
• Immediately accept receipt of the vaccines in VAOS.
Each package shipped from McKesson has a temperature monitoring strip.
If the monitor strip indicates, or if staff suspects that the cold chain has
been compromised, staff must immediately follow the instructions in
subsection D: Vaccines Received Warm or Questionable.
Staff at TVFC/ASN-enrolled sites must accept the vaccine at the time of receipt
in VAOS to maintain correct online vaccine inventory. While accepting an order
in VAOS, providers are required to report "Doses Passing Inspection" and
"Doses Failed Inspection". Any vaccine received in error, damaged, or with
questionable viability should be listed under “Doses Failed Inspection”.
DSHS reviews this information reported by sites daily for dissemination to the
distributer, manufacturer, or RE for more action.
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C. Manufacturer and Distributor Maintenance of the Cold Chain
The manufacturer and distributor pack the vaccine using qualified pack-outs
and containers that have been tested to maintain appropriate temperatures.
Refrigerated vaccine is packed to maintain the cold chain for 72 hours.
The vaccine will be shipped using high-quality cardboard boxes with
Styrofoam inserts.
Packages from McKesson are imprinted with “Temperature Sensitive Product”
and include stickers reading “Refrigerate upon Arrival” to alert clinic staff to
refrigerate contents immediately.
Varicella and MMRV are shipped directly from Merck. Merck products are
shipped frozen with a four-day pack-out. If the vaccine arrives within four
days of the pack date on the packing slip, then the vaccine is viable.
Staff must immediately place all vaccines in proper storage. If the vaccine
arrives outside of the four-day pack-out, the staff must immediately place
the vaccine in a “Vaccine Quarantine Bag” provided by the TVFC program,
store the vaccine properly, notify the RE and contact the manufacturer.
D. Vaccines Received Warm or Questionable
Vaccines must always be stored properly, even if viability is questionable.
Vaccines that are received warm, damaged, or in an otherwise questionable
state require immediate RE Contact. Questionable vaccines cannot be
identified visually and must be placed in a “Vaccine Quarantine Bag”
provided by the TVFC/ASN programs and separated in proper storage until
viability can be determined.
Examples are below of questionable (potentially non-viable) vaccines:
• Vaccine shipment received with temperature indicator strip showing out
of range
• Vaccine is warm to the touch
• Ice/gel packs are melted
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• Ice/gel packs are missing
• Vaccine is received damaged
If vaccine viability is questionable upon receipt:
• Place the probe of the backup data logger in the questionable shipment,
near the vaccine and replace the lid to gain the current temperature.
Temperatures must be checked frequently to see when the temperature
stabilizes.
• Separate the questionable vaccine in a “Vaccine Quarantine Bag” and place
the questionable vaccines in the refrigerator or freezer, as applicable, until
viability can be determined. Do not write on the vaccine itself.
• Contact the RE on the same day the vaccine arrived. If the RE is
unavailable, contact the distributor(s) to determine if a shipping issue has
occurred. Direct contact with the distributor(s) should only occur when
there is a questionable temperature during shipment.
• Inform the RE of the determination of the viability of the vaccine.
• Vaccine must be kept quarantined until instructions for replacement,
reporting loss, etc., are received.
NOTE: Vaccine returns due to shipping issues are required to be returned to
McKesson within 48 hours. Merck requires that frozen vaccine be returned
within 15 days of the original shipment.
E. Vaccines Received in Error
The RE must be contacted immediately upon receipt of vaccines that are
received in error. Staff at the TVFC/ASN-enrolled site may choose to keep
the vaccine if storage capacity is sufficient and the vaccine doses will be
administered. If vaccine was ordered by the site incorrectly, it is the site’s
responsibility to keep the vaccine. If the site cannot absorb the vaccine due
to storage capacity, the RE may assist in redistributing the vaccine to other
sites to prevent vaccine wastage.
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IV. Vaccine Loss
A. Expired, Spoiled and Ruined/Wasted Vaccine
The Immunization program requires all
unopened or unused vials and syringes of
expired TVFC/ASN program vaccines be returned
to the third-party distributor (McKesson).
Staff must not discard TVFC/ASN vaccine unless
specifically directed by the RE or the DSHS
Immunization program. Exception to this rule
will be communicated by the DSHS
Immunization program on a case-by-case basis.
Staff at TVFC/ASN-enrolled sites are to immediately notify the RE of vaccine
cold chain failure events or vaccine wastage incidents involving TVFC/ASN
program vaccines upon discovery of the incident.
Expired or spoiled vaccine is any non-viable vaccine in its original container
such as a vial or syringe. This includes expired vaccine or vaccine that has
been spoiled because of the following:
• Natural disaster/power outage
• Refrigerator temperature too warm (greater than 46°F or 8°C) or too cold
(less than 36°F or 2°C)
• Freezer too warm (greater than +5°F or -15°C)
• Vaccine was not stored properly upon receipt
• Vaccine was spoiled in transit due to provider error
• Vaccine was spoiled in transit due to shipper error; no replacement will be
sent
• Mechanical failure of a refrigerator or freezer unit
Purpose:
Expired or spoiled
vaccine must be
returned to the
distributor within six
months of the loss.
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Ruined/wasted vaccine is non-viable vaccine that cannot be returned.
Examples of ruined/wasted vaccines are below.
• Vaccine drawn into the syringe but was not administered.
• Vaccine in an opened multi-dose vial where all doses have not been
administered.
• If a multi-dose vial has been opened or accessed (e.g., needle-punctured)
the vial should be dated and discarded within 28 days unless the
manufacturer specifies a different (shorter or longer) date for that
opened vial.
• Compromised vial due to a drop causing damage to vial integrity or sterility.
• Expired open multi-dose vial, unable to return.
• Vaccine drawn into the syringe but refused by the patient.
• Incorrect vaccine that has been prepared for patient.
• Incorrect diluent was drawn or used for vaccine reconstitution.
Expired or spoiled vaccines must be removed from the storage unit, labeled
“Do Not Use” and stored pending return to the distributor. Expired diluents
do not need to be returned. Lost vials must be adjusted in VAOS.
Vaccine loss must be documented on a VLR in VAOS no later than four days
past the date of the incident(s). All vaccine returns to McKesson must occur
within six months of the loss.
B. Procedures for Vaccine Loss
Every dose of vaccine that is lost due to expiration or spoilage must be
reported to the TVFC/ASN programs on a VLR electronically in VAOS.
VLRs are generated electronically by completing the “Enter Vaccine Loss”
page in VAOS. Expired or spoiled vaccine must be returned to the distributor
within six months of the loss.
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Staff must follow the procedures listed below when a vaccine loss occurs:
• Complete the vaccine loss in VAOS to generate a VLR. VLRs must be
generated within four days after the date of the incidence or loss.
• Remove expired or spoiled vaccine from the vaccine storage unit and
place in a “Vaccine Quarantine Bag”.
• Contact the RE immediately with the following information:
• Antigen
• Lot number
• Expiration date
• Reason for the loss
• If the storage unit was compromised, provide the RE with amount of time
the product was out-of-range and the highest and lowest temperatures
recorded (this information may be gathered by performing a download of
the data logger).
• Document the vaccine loss in VAOS to generate a VLR electronically
within four days after the date of the incident or loss. Explain the
cause(s) of the loss and outline the steps taken to ensure vaccines will be
protected in the future.
• The VLR must be printed and signed by medical personnel with the
prescribing authority listed on the site’s enrollment form. The report must
be uploaded in the “Files” section of VAOS for review by the RE. Sites are
not allowed to use signature stamps on the VLRs as the signing authority
is expected to be fully aware of the loss in the clinic.
• The following sections are required to be filled out on a VLR:
• Clinic demographics
• Date loss was discovered
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• Type of loss
• Reason for the loss
• Corrective action taken to avoid re-occurrence and
• List of vaccines by antigen, manufacturer, lot number, expiration date
and number of doses lost
The primary vaccine coordinator will receive a shipping label via email for
returning expired or spoiled vaccine. Depending on the number of doses lost,
multiple shipping labels may be received. Staff must wait until UPS returns
to the TVFC/ASN-enrolled site to pick up the expired or spoiled vaccine to
avoid paying a fee. Shipping labels expire after 30 days. If a provider
received a shipping label and UPS has not picked up the package within
30 days, staff must contact the RE for a new shipping label.
• Staff must ensure all vaccines listed on the VLR are included in the box
for return. Do not return broken vials or syringes with needles attached.
• If more than one box is used to return non-viable vaccine, staff must
indicate on the VLR the number of the box in which the vaccine is being
shipped (e.g., “Box 1 of 2,” “Box 2 of 2,” etc.). Each box used to return
vaccine must not weigh more than 70 pounds.
• Ruined or wasted vaccine (vaccine or diluent drawn into a syringe but
administered or refused by the patient, opened multi-dose vials, broken
vials, or lost vials) listed on the VLR that was download from VAOS must
be marked through with a single line as they must not be included in the
box for return.
NOTE: Only unbroken, sealed vaccine vials or syringes may be included for
return. Broken vials, opened multi-dose vials, or syringes with a needle
attached must never be included in the box.
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Staff must wait until UPS returns to the site with the next delivery to
return the box. Calls to UPS to schedule a pick-up will be subject to a fee
set by UPS. McKesson will not schedule pick-ups on behalf of
TVFC/ASN-enrolled sites unless special arrangements are made by the DSHS
Immunization program.
Enrolled sites that have lost vaccine because of improper temperature
storage must assess how long the vaccines were stored improperly and how
many children may have received the affected vaccines. The signing clinician
determines whether children will need to be recalled and revaccinated.
The TVFC/ASN programs will not provide the vaccine for recalled clients in
these circumstances. The clinic will assume all financial responsibility for the
cost of vaccines for recalls. Clinic staff must contact the RE with the
determination from the signing clinician.
C. Negligent Vaccine Loss
Signing clinicians at TVFC/ASN-enrolled sites are responsible for negligent
vaccine losses. Following are examples of vaccine negligence:
• Drew up vaccine dose and the parent or patient refused.
• Drew up the wrong vaccine including:
• The vaccine was mixed with the wrong diluent
• Only diluent was administered
• Dropped vaccine dose resulting in:
• Damage to the vial integrity or sterility
• Compromised vial
• Expired vaccine and the site did not notify RE 60 to 90 days before
expiration.
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• Failure to store vaccine properly, including:
• Vaccines that were left out of appropriate storage
• Improper monitoring of unit temperatures
• Refrigerator temperature too cold.
• Storage temperature too warm, including:
• Unit was unplugged either accidently or intentionally and a plug guard
was not used
• Unit door left open
• Temperatures were not documented or were monitored improperly
• Vaccine was spoiled in transit due to clinic staff error including:
• Vaccine transfers
• Refused vaccine shipment
• Vaccine was delivered when the clinic was closed, and the closure was
not documented in VAOS.
• Vaccine was stored improperly including:
• Vaccine was left out of appropriate storage unit
• Not stored properly upon receipt
TVFC or ASN-enrolled sites may be required to reimburse the DSHS
Immunization program for vaccine losses that occur due to negligence.
D. Non-negligent Vaccine Loss
Non-negligent vaccine losses include the following:
• Damaged needle or seal, particulate in the vial, or discolored product
• Expired flu, DT, pediatric Td, pediatric PPSV
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• Expired and the clinic staff notified RE 60 to 90 days before expiration
and the RE was unable to transfer
• Mechanical failure of refrigerator or freezer
• Natural disaster or power outage
• Unable to transfer opened multi-dose vial and
• Vaccine spoiled in shipment due to shipper error.
E. Vaccine Disposal
The CDC advises providers dispose of vaccines in accordance with local
regulations. The Texas DSHS follows the Texas Commission on Environmental
Quality’s (TCEQ) guidance on proper medical waste disposal of wasted
vaccine. The TCEQ and DSHS define medical waste as special waste from
health care-related facilities (25 TAC 1.132[46] and 30 TAC 326.3[23]), which
includes treated and untreated animal waste, bulk human blood and body
fluids, microbiological waste, pathological waste and sharps.
Following TCEQ’s guidance on medical waste disposal, dispose of needles
and associated vials in a clearly labeled sharps container, treating it as a
contaminated biohazard container. Wipe down and sanitize work areas.
After disposing of vaccine, take off and dispose of gloves and thoroughly
wash hands with soap and water for at least 20 seconds or use an alcohol-
based hand sanitizer that contains at least 60% alcohol.
Additional information on local regulations for how to treat and dispose of
medical waste in Texas, can be found on TCEQ’s website or by emailing
info@tceq.texas.gov.
V. Vaccine Storage and Handling
Proper receipt and storage of a vaccine delivery is important to maintain the
vaccine cold chain. The cold chain, or temperature monitoring, begins with
the cold storage unit at the manufacturing plant, extends through transport
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of vaccines to the distributor and continues through the delivery to and
storage at the enrolled facility and ends with the administration of vaccine to
the patient. Exposure to heat, cold, or light at any step in the cold chain can
damage vaccines, resulting in loss of potency.
Failure in the cold chain can be costly. If there is a failure in the cold chain,
the result can mean extra doses for patients, increased costs for sites and
damage to public confidence in vaccines. A loss of public confidence in
vaccines can lead patients to refuse revaccination and remain unprotected
from serious vaccine-preventable diseases. Maintaining the vaccine cold
chain will avoid incurring additional costs associated with losing and
replacing vaccines, as well as the need to recall patients for revaccination.
A. Refrigerator and Freezer Requirements
TVFC/ASN-enrolled sites are required to have appropriate equipment that
can store vaccine and maintain proper conditions. The following are strong
recommendations.
• Refrigerator and freezer units must be
large enough to hold the year’s largest
inventory without crowding (such as flu
season or back-to-school).
• The DSHS Immunization program
recommends the following types of units,
listed in preferential order:
• Pharmaceutical/purpose-built units
• Stand-alone, single-purpose refrigerator and stand-alone
single-purpose freezer
• Combination household unit
NOTE:
Refrigerator and freezer
units must be large
enough to hold the
year’s largest inventory
without crowding.
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• In the event a combination household unit is used, the site is strongly
encouraged to obtain a stand-alone freezer. Refrigerated vaccine should
be stored in the household unit and frozen vaccine should be stored in the
stand-alone freezer. Use of the freezer compartment of a household
combination unit is discouraged.
• Any currently enrolled provider using both compartments of a household
combination unit that consistently maintains the required temperature
ranges, may continue to do so. The provider must discontinue use if
temperature excursions occur that can't be attributed to another cause
(e.g., power outage).
• Providers enrolled after July 1, 2024, will not be allowed to use the
freezer compartment of a household combination unit.
• Dorm-style and small combination refrigerator and freezer units with a
single external door are never allowed for the storage of
TVFC/ASN vaccine.
• Refrigerators with solid glass shelves are
approved for use.
• The refrigerator compartment must
maintain temperatures between 36°F and
46°F (2°C and 8°C) for vaccine viability.
The refrigerator temperature should be set
at 40°F (4°C).
• The freezer compartment must maintain
temperatures between -58°F and +5°F
(-50°C and -15°C) for vaccine viability.
• An alarm system and backup generator are recommended to help reduce
vaccine loss when unexpected temperature fluctuations occur.
• Refrigerators and freezers storing vaccines must be plugged directly into
a wall outlet with a plug guard installed to prevent accidental or
intentional unplugging.
NOTE:
DSHS prohibits the use
of the following in units
containing TVFC/ASN
vaccine:
• Gel packs
• Ice packs
• Vaccine shipment
coolant packs
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• Units containing TVFC/ASN vaccine must not be plugged into a multi-strip
power outlet, surge protector, or an extension cord. In addition, units
must not be plugged into an outlet controlled by a wall switch or GFI
outlets.
NOTE: You may see vendors use terms such as "VFC-Compliant,"
"CDC-Compliant," or "satisfies VFC Requirements" in their marketing
materials or on their websites. Should you encounter this type of language in
vendor marketing materials, remember that the TVFC/ASN programs have
not validated any product or service for compliance with TVFC/ASN
programs requirements or standards.
Each refrigerator and freezer must contain a sufficient number of water
bottles to help maintain proper storage temperature during peak usage of
the unit or during a power outage. Peak usage is when there is frequent
opening and closing of the unit.
Water bottles serve as a physical barrier to prevent placing vaccines in areas
where there is greater risk for temperature excursions.
The following cooling materials must not be used in units containing
TVFC/ ASN program vaccine.
• Gel packs (thawed or frozen)
• Ice packs
• Coolant packs from vaccine shipments
• Any other coolant material that is not allowed by CDC or
TVFC/ASN programs
NOTE: Water bottles should not be used in pharmaceutical/purpose-built
units if the manufacturer indicates that water bottles negatively impact the
functionality of the unit.
Depending on the size of the unit, the amount of vaccine stored and the time
of year, “sufficient” may differ from one clinic to the other.
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However, there must be adequate water bottles in each refrigerator and
adequate frozen water bottles in each freezer to help maintain proper
storage temperature during peak usage of the unit or until vaccines can be
moved to another refrigerator or freezer. All empty space in the unit should
be filled with water bottles.
• For the refrigerator:
• Ensure the door closes completely.
• Replace crisper bins with water bottles to help maintain a consistent
temperature (unless used for other medical equipment or supplies).
• Label water bottles “Do Not Drink”.
• Post “Do Not Unplug” signs on the refrigerator, at the electrical outlet
and at the circuit breaker.
• Place water bottles in unit doors carefully so they do not dislodge and
prevent the doors from closing or weigh down the door so much that it
does not seal tightly.
• Place water bottles on the top shelf of the refrigerator under the fan
(if present).
• Do not use the top shelf for vaccine storage.
• Do not store food or beverages in the refrigerator with vaccines.
• Do not put vaccines in the doors or on the floor of the refrigerator.
• Do not drink from or remove the water bottles.
• Leave two to three inches between all vaccines (if possible) and the
refrigerator walls.
• Vaccine with diluent must be kept together in the same box. The
Merck diluent for MMR, MMRV and VAR vaccines may be stored in the
door of the refrigerator, but this diluent does not require refrigeration
and must not be frozen.
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• Place vaccines with the earliest expiration dates in front of those with
later expiration dates.
• Whenever possible, store diluent with the corresponding refrigerated
vaccine. Diluents must not be frozen.
• Attach labels to shelves and containers to identify where each type of
vaccine and diluent is stored. If diluent is stored separately from the
corresponding vaccine, label the container where it is stored. Store
vaccines and diluents with similar packaging or names (e.g., DTaP and
Tdap or Hib and Hep B) or with both pediatric and adult formulations
on different shelves to minimize the risk of administration errors.
• Label the formulation “pediatric” or “adult,” if applicable.
• Always store vaccines in their original packing with lids closed until
ready for use unless vaccines are stored in an auto-dispensing unit that
requires vaccines to be removed from the original packing.
• Never store loose vials or manufacturer-filled syringes outside of
their packaging.
• Do not pack a storage unit too tightly. This may result in restricted air
circulation and impact the unit’s temperature.
• Vaccines must be centrally stored within the unit.
• Store privately purchased vaccine on different shelves from
TVFC/ASN program vaccine to minimize the risk of administering
TVFC/ASN program vaccine to non-eligible patients. TVFC/ASN
program vaccines must be clearly marked to differentiate them from
privately purchased vaccines.
• For the freezer:
• Ensure the door closes completely.
• Use frozen water bottles to help maintain a consistent temperature.
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• Place water bottles against the walls, in the back, on the floor and in
the door racks.
• Place water bottles in unit doors carefully so they cannot dislodge and
prevent the doors from closing or weigh down the door so much that it
does not seal tightly.
• Post “Do Not Unplug” signs on the freezer and by the electrical outlet.
• Do not store food in the freezer.
• Leave two to three inches between all vaccines and the freezer walls.
• Do not store vaccines in the freezer doors.
• Avoid storing vaccines in any part of the unit that may not provide
stable temperatures or sufficient air flow, such as directly under
cooling vents or shelves on the door.
• Store each type of vaccine in a separate container.
• Vaccines must be centrally stored within the unit.
• Place vaccines with the earliest expiration dates in front of those with
later expiration dates.
• Attach labels to shelves and containers to clearly identify each type of
vaccine.
• Store vaccines with similar packaging or with pediatric and adult
formulations on different shelves to minimize the risk of administration
errors.
• Store privately purchased vaccine in a clearly marked container
separate from TVFC/ASN program vaccine to ensure TVFC/ASN
program vaccine is not inadvertently administered to a
non-eligible patient.
• Clearly label the formulation “pediatric” or “adult,” if applicable.
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• Always store vaccines in their original packaging with lids closed until
ready for administration.
• Never store loose vials or manufacturer-filled syringes outside of their
packaging.
• Diluents must not be frozen.
• Do not pack a storage unit too tightly. This can restrict air circulation
and impact vaccine temperature.
• For Auto-Dispensing Units:
DSHS has approved the use of auto-dispensing or doorless units to store
TVFC/ASN program vaccines. This type of unit is purposely built to store
vaccines. Loading vaccines in this type of unit is the only time vaccines
should be kept outside of their original packaging however, providers
must keep all the original vaccine packaging in the event the vaccine has
to be transported outside of the unit.
A service record is required for auto-dispensing units in lieu of a
certificate of calibration. Servicing must be completed on auto-dispensing
units as specified by the manufacturer. Monthly temperature logs must be
recorded and submitted on the seventh of each month. As with other cold
storage units, ensure that temperature logs are posted on the unit.
NOTE: TVFC/ASN program vaccine that is stored in an auto-dispensing
or door-less purpose-built unit may require vaccine to be removed from
the original packaging. The original packaging must be kept and readily
accessible in the event the vaccine must be transported outside of
the unit.
New or Repaired Units:
Prior to using a new or newly repaired unit to store vaccines, the TVFC/ASN
programs require seven operational days of refrigerator or freezer
temperature recordings (twice daily) on a “Temperature Recording Form,”
stock no. EC-105, using a certified calibrated data logger.
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Minimum and maximum temperatures are required to be recorded once
daily, at the beginning of each business day, to ensure temperatures are
within appropriate ranges.
Submit the recordings to the RE for review and approval, before placing
vaccine in the storage unit. Minimum and maximum temperature readings
must be reset from the day before at the end each business day
(if the device requires this function).
If adjustments to a unit’s temperature control is necessary, read the
instructions carefully and verify that the temperatures did not change
overnight. Some manufacturers recommend resetting the controls in the
summer and winter. If so, post instructions on the unit door.
Refrigerators and freezers that store TVFC/ASN program vaccines are to be
dedicated to storing vaccine only. Food or drinks are not allowed in the
refrigerator or freezer with vaccines. If other biologics must be stored in the
same unit, store them below the vaccines to avoid contamination.
Maintaining TVFC/ASN program temperature logging requirements is
mandatory for all TVFC/ASN-enrolled sites. The required steps are listed.
• A “Temperature Recording Form,” stock no. EC-105, is required to be
located on or near all vaccine storage units that store TVFC/ASN program
vaccines, including auto-dispensing units.
• Freezer and/or refrigerator temperatures are required to be checked from
a certified calibrated data logger, recorded and initialed twice daily.
• Minimum and maximum temperatures must be recorded on the
temperature recording form once at the beginning of each business day.
• Minimum and maximum temperature readings must be reset from the
day before at the end of each business day.
• Temperatures must be recorded manually on temperature recording
forms, using a data logger.
• Data loggers must be able to be reset on site.
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• Temperature recording forms must still be completed and submitted to
your RE if an auto-dispensing unit is being utilized; and
• Temperature recording forms must be maintained for five years and
made easily available.
If an out-of-range temperature excursion is
observed, the clinic staff must document all
excursions and take the following actions
immediately.
• Place vaccines in a
“Vaccine Quarantine Bag”.
• Store vaccines in a unit where they can
be kept under appropriate conditions.
• Generate a report from the data logger for discussion with help from the
vaccine manufacturer.
• Contact the vaccine manufacturer that is listed on the box to obtain
documentation for the viability of the vaccine.
Contact the RE to report the manufacturer’s vaccine viability determination,
submit the manufacturer’s determination letter(s) or online validity results
and complete the “Vaccine Storage Troubleshooting Record” on page 3 of
the “Temperature Recording Form,” stock no. EC-105.
Figure 3-1 illustrates the steps for handling a temperature excursion in your
vaccine storage unit.
NOTE:
TVFC/ASN-enrolled sites
using data loggers must
comply with twice daily
temperature recordings
and once daily
minimum/maximum
recording requirements.
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Figure 3-1.
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B. Data Logger Requirements
DSHS requires at least one data logger and at least one back-up data logger
for all units that contain TVFC or ASN program vaccines.
Units that store TVFC/ASN program vaccines must contain a centrally
located data logger probe with a current and valid Certificate of Calibration
Testing, also known as a “Report of Calibration” (see page 71, Figure 3-2),
set at a minimum recording interval of at least every 30 minutes.
A data logger provides more accurate and comprehensive monitoring of
temperature excursions to which vaccines may be exposed. Using a data
logger may reduce vaccine loss by providing necessary data when the
vaccine would otherwise be lost.
Staff at TVFC/ASN-enrolled sites that use data loggers must still comply with
twice-daily temperature recordings and once daily minimum and maximum
recording requirements. When reading the data logger, do not round the
numbers up or down; record the numbers on both sides of the decimal point
and do not round (Ex: For 46.1°F or 8.1°C, note that the numbers to the
right of the decimal meet the criteria for a temperature excursion).
If a temperature excursion occurs based on the updated guidance,
TVFC/ASN program providers must reach out to the vaccine manufacturer to
obtain guidance on vaccine viability. Temperatures must not be converted
from Fahrenheit to Celsius or Celsius to Fahrenheit. It is recommended that
staff download the data from their data loggers at least once per week, on
Mondays, to ensure that any excursions are identified and addressed in a
timely manner.
The following are requirements for data loggers:
• An active temperature display that can be easily read by all staff from the
outside of the unit, without having to open the door.
• The data logger must have functionality that does not require a computer
password to access the temperature display.
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• The display must remain active for temperature readings (i.e., must not
have sleep mode turned on).
• An alarm for out-of-range temperatures.
• A display that shows the current temperature and minimum and
maximum temperatures.
• A low battery indicator.
• Accuracy of +/-1°F (+/-0.5°C).
• Detachable probe in buffered material.
• Memory storage of at least 4,000 readings (device must not rewrite over
old data and must stop recording when the memory is full).
• User-programmable logging interval (or reading rate) at a maximum time
interval of every 30 minutes.
Probes must be in buffered material so that they measure temperatures that
are more representative of the temperature of the vaccine in the vial rather
than the air temperature of the storage unit.
Examples of buffers include the following:
• A vial filled with liquid (glycol, ethanol, glycerin).
• A vial filled with loose media (sand, glass beads).
• A solid block of material (Teflon
®
, aluminum).
The TVFC/ASN programs do not allow the following temperature monitoring
devices:
• Alcohol or mercury thermometers, even if placed in a fluid-filled bio-safe
liquid vial.
• Bi-metal stem temperature monitoring devices.
• Food temperature monitoring devices.
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• Household mercury temperature monitoring devices
• Chart recorders
• Infrared temperature monitoring devices
• Thermometers
These devices can have significant limitations, can be difficult to read and
generally only provide information on the temperature at the precise time
they are read. Therefore, temperature fluctuations outside the
recommended range may not be detected.
The following are requirements for placing data logger probes:
• In the center of the unit
• As close to the vaccine as possible
• Away from walls, ceilings, cooling vents, doors, floor and back of the unit
NOTE: In pharmaceutical or purpose-built units, the data logger probe is
recommended to be placed in a central location; however, other placements
may be suitable because these units maintain more consistent temperatures
throughout the unit.
The data logger probe must not be
suspended from wire shelves or suspended
by tape or other means attached to the
inside ceiling of the unit.
TVFC/ASN-enrolled clinic sites are required to
have a calibrated data logger in each unit
that stores TVFC/ASN program vaccine that
is either International Laboratory
Accreditation Cooperation (ILAC) laboratory
accredited or has a valid and up-to-date
certificate issued by an ILAC laboratory.
NOTE:
The backup data logger
is recommended to have
a different calibration
retesting date. By
having different
calibration dates, there
will always be one data
logger available for use.
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A valid “Certificate of Calibration” matching the serial number of the data
logger in use must be readily available for review and is recommended to be
posted on or near the refrigerator and/or freezer. Calibration testing is
required every two to three years or according to the manufacturer’s
suggested timeline. All “Certificates of Calibration” must be sent to your RE
who will submit them to DSHS Central Office for processing. Providers with
expired data logger “Certificates of Calibration” will be suspended until
current certificates are received. A continuous-read temperature-recording
device does not replace the requirement for a certified data logger. Photos of
the data logger do not meet the “Certificate of Calibration” requirements and
will not be accepted.
Data logger “Certificates of Calibration” must contain the following:
• Model number
• Serial number
• Date of calibration
• Measurement results that indicate the unit passed the test and the
documented uncertainty is within suitable limits (+/-1°F [+/-0.5°C])
• A statement indicating that it meets International Organization for
Standardization/International Electronic Commission (ISO/IEC) 17025
standards
All clinic sites must have at least one backup data logger with a valid and
current “Certificate of Calibration”. Backup data loggers must be readily
available in the event the primary data logger that is in use is no longer
working appropriately, in the event of an emergency transport of vaccine, or
if calibration testing of the current equipment is required.
The backup data logger must be stored outside of the storage unit until
needed to avoid vaccine space issues and differing temperature readings
leading to potential confusion.
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The backup data logger is recommended to have a different calibration
retesting date. If both data loggers have the same calibration date, they will
need to be sent out for recalibration at the same time. This will also
negatively impact the results of the TVFC program compliance site visit.
Having different calibration dates for data loggers ensures there will always
be one data logger available for use.
Refrigerators and freezers that are manufactured with built-in temperature
monitoring capabilities are required to be accompanied by a “Certificate of
Calibration” (see Figure 3-2) and the thermostat must be capable of being
adjusted as needed to maintain proper temperature. These units must meet
all TVFC/ASN program data logger requirements.
In addition, a room thermometer is required to record the room temperature
when a temperature excursion occurs in a vaccine storage unit. This is
important for making vaccine viability determinations, if necessary.
Figure 3-2. Example of a data logger Certificate of Calibration.
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C. Vaccine Storage Requirements
Some vaccines are sensitive to light and their efficacy could be compromised
if exposed to light. The following vaccines must be protected from light
MenB, Hib, HPV, MCV4, MMR, MMRV, Rotavirus and Varicella.
All these vaccines, except Varicella and MMRV, are to be stored in the
refrigerator and must never be frozen. Varicella and MMRV must be stored in
the freezer in a continuously frozen state between -58°F and +5°F (-50°C and
-15°C). MMR vaccine may be stored in either a refrigerator or freezer.
All vaccines must be stored in the central area of the refrigerator and/or
freezer, not in the vegetable bins, meat drawers, in the door, or on the floor.
Storing vaccines in the central body of the refrigerator and/or freezer helps
maintain proper temperatures for the vaccines.
Vaccines must be stored and/or stacked to allow cold air to circulate freely.
All TVFC/ASN program vaccines must be stored separately from privately
purchased vaccines and must be labeled accordingly.
Clinics that are also enrolled in the ASN program must separate
TVFC-provided pediatric doses from ASN-supplied adult doses. Sufficient
alternate space to store vaccines and maintain the cold chain during any
period when the refrigerator/freezer is out of service must be identified.
D. Protective Equipment
The power supply for vaccine storage units must be protected by ensuring
these practices are followed.
• Plug unit(s) directly into a wall outlet
• Plug only one unit into an outlet
• Plug guards are required to be used on all units that store TVFC/ASN
program vaccines. Plug guards are effective tools in preventing the
accidental or intentional unplugging of equipment.
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• A “Do Not Unplug” sign is required to be posted on or near all outlets
where units are plugged in.
• A “Do Not Disconnect” sign must be posted on or near each circuit
breaker.
Do not use the following for units that contain TVFC/ASN program vaccine:
• Extension cords
• Multi-outlet power strips
• Power outlets that can be activated by a wall switch
• Outlets with built-in circuit switches (GFI receptacle)
• Surge protectors
E. Personnel
Vaccine viability depends on the knowledge and habits of the clinic staff.
All staff who handle TVFC/ASN program vaccine must be trained on proper
storage, handling and administration of
vaccine as well as awareness of and familiar
with the written procedures for emergency
situations to assure continued viability of the
vaccines. The site is required to designate a
primary and one backup vaccine coordinator
to ensure that TVFC/ASN program vaccines
are handled and stored properly.
The following are training requirements for vaccine coordinators:
• Primary and backup vaccine coordinators at all new TVFC/ASN-enrolled
sites must complete the mandatory the most current TVFC/ASN “Provider
Policy Training” module, VAOS Training and the CDC “You Call the Shots”
training modules 10 and 16 and provide the certificates of completion to
the RE.
NOTE:
The primary and backup
vaccine coordinators
must complete the
current TVFC/ASN
Provider Policy Training
module.
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• Replacement primary and/or backup vaccine coordinators must complete
the mandatory the most current TVFC/ASN “Provider Policy Training”
module, VAOS Training and the CDC “You Call the Shots” training
modules 10 and 16 and provide the certificates of completion to the RE.
• During re-enrollment, the primary and backup vaccine coordinators must
complete the mandatory the most current TVFC/ASN “Provider Policy
Training” module and upload the certificates of completion to the
electronic re-enrollment form.
The Immunization program has developed “Texas Vaccine Education Online”
(VEO) modules to provide short online training courses on topics related to
vaccines. Individuals may log in and take any course free of charge.
Additional information and a course listing are available at
https://learningportal.hhs.texas.gov/course/index.php?categoryid=45.
F. Routine and Emergency Storage and Handling Plan
All TVFC/ASN-enrolled sites must have plans for routine and emergency
vaccine management. The TVFC/ASN programs provide templates for the
“Vaccine Management Plan” and the “Emergency Vaccine Storage and
Handling Plan Checklist,” stock no. E11-14498.
The plan and checklist templates contain comprehensive information on best
practices and the most current information about the storage and handling
of vaccines.
Clinics are not required to use these templates, but they are valuable tools
should assistance be needed when developing an emergency plan. If the
templates are not used, staff at the site must develop routine and
emergency vaccine management plans that include all the information on
the templates provided by the TVFC/ASN programs.
The “Vaccine Management Plan” and the “Emergency Vaccine Storage and
Handling Plan Checklist,” stock no. E11-14498 must be reviewed and
updated annually. The signature, name and title of the preparer as well as
the date the documents were reviewed, must be documented.
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The following items must be addressed in the “Emergency Vaccine Storage
and Handling Plan”.
• Identify a responsible primary and backup person for the contingency
plan. Contact information such as email addresses and home, office and
cell phone numbers must be included for both. Contact information must
be updated annually or when changes occur.
• Identify an alternative location to take the TVFC/ASN program vaccine for
storage in the event of an emergency. A location with a power generator
or other alternate source of power, such as a hospital or pharmacy is
preferable. Ideally, this facility must be located within a reasonable
distance from the clinic site and can maintain the cold chain during any
period when the TVFC/ASN program clinic’s refrigerator and/or freezer is
out of service, as well as adequate space to accommodate the largest
vaccine inventory.
Temperatures for these temporary storage units are required to be
monitored and recorded.
• An adequate quantity of supplies sufficient for packing and transporting
the entire TVFC/ASN program vaccine inventory must be available at the
enrolled site, in case of an emergency.
• Contact with staff at the emergency storage location is important to gain
their approval before including them as part of the plan. List their contact
person(s) and phone number(s) on the plan. An alternative backup
location must be considered if the primary alternative location is
unavailable or unable to store the vaccine inventory for any reason.
• Due to strict temperature, storage and monitoring requirements of
vaccines, the Texas DSHS does not permit TVFC/ASN program vaccines
to be stored at a private residence.
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• Private residences include, but are not limited to, the part of a structure
used as a dwelling, including, without limitation: a private home,
townhouse, condominium, apartment, mobile home, vacation home,
cabin, or cottage. DSHS reserves the right to decline to send vaccine to
providers as it deems appropriate.
The most current “Emergency Vaccine Storage and Handling Plan” will be
reviewed during TVFC program Compliance Site Visits and Unannounced
Storage and Handling Visits. The documents must be posted on or near the
refrigerator or freezer that contains TVFC/ASN program vaccine. The clinic
staff involved with vaccine management must be aware of this plan.
G. Vaccine Protection in the Event of an Emergency
As noted above, every facility maintaining an inventory of TVFC/ASN
program vaccine is required to develop and display an “Emergency Vaccine
Storage and Handling Plan,” in the event of emergencies that could result in
the loss of vaccine. Once completed, this template can serve as the required
“Emergency Vaccine Storage and Handling Plan,” stock no. 11-14498.
This plan must be reviewed and updated annually or more frequently if there
are any changes to the plan or changes in staff responsible for vaccine
management, storage and handling.
In the event of an emergency, the RE must be contacted immediately to
inform of the situation.
Staff at enrolled sites must be prepared to provide the following information:
• The temperature of the vaccine
• The amount of vaccine
• Expiration dates of the vaccine
• The amount of time the vaccine was exposed to inappropriate temperatures
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The following information must be collected when transporting vaccine to the
alternate location:
• Document the time of the emergency/power outage.
• Document the temperature of the refrigerator and freezer before
removing any vaccine for transportation.
• Indicate which containers are being used and how the refrigerated
vaccine will be packed for transportation (e.g., conditioned water bottles
separated from the vaccine by layered packing materials to prevent
freezing and damage).
• If frozen vaccine is being transported, indicate whether a portable freezer
or cooler will be used and what packing materials will be used.
• Take inventory of the vaccine as it is moved into the transport container,
documenting the number of doses of each vaccine and the expiration
dates. Use a “Vaccine Transfer Authorization Form” which must be
completed and uploaded to VAOS.
• Ensure the “Emergency Vaccine Storage and Handling Plan Checklist” is
available for documenting this process.
H. Cold Chain Management and Vaccine Transport
The TVFC/ASN programs require vaccines to be stored properly from when
they are manufactured until when they are administered. The system used
to maintain and distribute vaccines in optimal condition is called the cold
chain.
Sufficient alternative space to store TVFC/ASN program vaccines and
maintain the cold chain during any period when the refrigerator or freezer is
out of service must be identified. Adequate supplies for packing and
transporting the entire TVFC/ASN program vaccine supply/inventory must be
available in case of an emergency.
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These packing supplies must be available to show during the TVFC program
Compliance Site Visit. Facilities that do not have these materials on hand
during the site visit will be contacted by their RE.
Avoid prolonged temperature extremes
inside vehicles by taking the quickest
route possible. Do not leave vaccines
unattended in vehicles. Do not place
vaccines in the trunk of a vehicle.
Pack refrigerated vaccines first. If
followed, the directions below will
help maintain the cold chain for up
to eight hours during transport of
refrigerated vaccines.
Refrigerated Vaccine Transport
Assemble Packing Supplies
DSHS recommends transporting refrigerated vaccines with a portable
refrigerator unit. If this type of unit is not available, a hard-sided insulated
cooler with at least two-inch walls, Styrofoam vaccine shipping container, or
other qualified container may be used if it maintains the recommended
temperature range (36°F to 46°F [2°C to 8°C]).
• Using a hard-sided cooler, Styrofoam vaccine shipping container, or other
qualified container requires the following:
• Coolers should be large enough to hold the TVFC/ASN supply of
refrigerated vaccines.
• Label the container with the facility name and “Fragile Vaccines – Do Not
Freeze” and the date and time the vaccine was removed from the
permanent storage unit.
NOTE: Do not use soft-sided collapsible coolers for transporting vaccines.
NOTE:
Adequate supplies for packing
and transporting the entire
TVFC/ASN vaccine supply
must be available in case of
an emergency. These supplies
must be available to show
during the TVFC/ASN
Compliance Site Visit.
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• Conditioned frozen water bottles are required.
• Use 16.9 oz. bottles for medium/large coolers and 8 oz. bottles for
small coolers.
• Before use, condition the frozen water bottles. This is done by placing
them in a sink filled with several inches of cool or lukewarm water until
there is a layer of water forming near the inner surface of the bottle.
• The bottle is properly conditioned when the ice block spins freely
within the bottle when rotated.
NOTE: Do not reuse coolant packs from original vaccine shipping containers.
• Insulating material – two each of the following layers is needed.
• Corrugated cardboard – two pieces cut to fit the internal dimensions of
the cooler(s) and placed between the insulating cushioning material
and the conditioned water bottles.
• Insulating cushioning material such as bubble wrap, packing foam, or
Styrofoam for a layer at least two inches thick above and below the
vaccines. Ensure this layer covers the cardboard completely.
NOTE: Do not use packing peanuts or other lose material that may shift
during transport. If a portable vaccine refrigerator unit is used to transport
vaccines, follow the manufactures requirements regarding the use of use
packing material, i.e., bubble wrap or cardboard.
• A data logger with a buffered probe must be used as a temperature
monitoring device.
• Prepare the probe by pre-chilling it in the refrigerator for at least five
hours prior to transport.
• Ensure the data logger has a current and valid “Certificate of
Calibration” testing.
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• Ensure the data logger certificate is documented to be accurate within
+/- 1°F (+/- 0.5°C).
• The data logger currently stored in the refrigerator can be used for
transport if there is a device in place to measure the temperature for
remaining vaccines.
Packing for Transport
• Line the bottom of the cooler with a single layer of conditioned
water bottles.
• Place a sheet of corrugated cardboard over the water bottles.
• Place at least a two-inch insulating layer (i.e., bubble wrap, packing
foam, or Styrofoam) over the cardboard.
• Stack boxes of vaccines on top of insulating material.
• When cooler is halfway full, place the data logger buffered probe in the
center of the vaccines, but keep the display outside the cooler.
• Cover vaccines with another two-inch layer of insulating material.
• Add the second layer of corrugated cardboard.
• Fill the remaining space in the cooler with conditioned water bottles.
• Close the lid of the cooler securely and attach the data logger display and
a temperature log to the top of the lid to record and monitor the
temperature during transport.
• Use the vaccine transport log to record the time and temperature inside
of the storage unit at the time the vaccines are removed.
• If vaccines are kept in a transport container for longer than an hour,
record the temperatures hourly.
• As soon as the destination site is reached, check and record the vaccine
temperature.
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If the vaccine temperature is 36°F to 46°F (2°C to 8°C), place the vaccine in
the refrigerator.
If the vaccine is below 36°F (below 2°C) or above 46°F (above 8°C), place
the vaccine in a quarantine bag in the refrigerator and immediately contact
the vaccine manufacturer to determine viability. Next, contact the RE with
the manufacturer’s viability determination.
NOTE: Always keep vaccine properly stored until otherwise instructed by the
vaccine manufacturer or the TVFC/ASN programs.
Frozen Vaccine Transport
Varicella and MMRV vaccines are fragile and must be kept frozen.
DSHS and the vaccine manufacturer do not recommend transporting
varicella or MMRV. If these vaccines must be relocated in an emergency, the
following steps must be taken:
Assemble Packing Supplies
• Portable Freezer – DSHS recommends transport with a portable freezer
unit that maintains the temperature between -58°F and +5°F (-50°C and
-15°C). Portable freezers may be available for rent. Label the portable
freezer with the facility name and “Fragile Vaccines – Keep Frozen” and
the date and time the vaccine was removed from the permanent storage
unit.
NOTE: If a portable vaccine freezer unit is used to transport vaccines,
follow the manufactures requirements regarding the use of use packing
material, i.e., bubble wrap or cardboard.
• Temperature Monitoring Device – Use a certified and calibrated data
logger with a current and valid “Certificate of Calibration” testing.
Prepare the data logger by placing it in a freezer unit at least two
hours before packing the vaccine.
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• Cooler – If a portable freezer is unavailable, a hard-sided insulated cooler
with at least two-inch walls, a Styrofoam vaccine shipping container, or
another qualified container may be used if temperatures between -58°F
and +5°F (-50°C and -15°C) can be maintained. Label the container with
the facility name and “Fragile Vaccines – Keep Frozen” and the date and
time the vaccine was removed from the permanent storage unit.
• Use frozen water bottles in the cooler. Dry ice cannot be used for
transporting vaccines, even for temporary storage or emergency
transport. Dry ice exposes the vaccine to temperatures colder than -58°F
(-50°C).
• Line the bottom of the cooler with a single layer of frozen water bottles.
• Place at least a two-inch layer inch of insulating material (i.e., bubble-
wrap, packing foam, or Styrofoam) over the frozen water bottles.
• Stack boxes of vaccines and diluents on top of insulating material.
• When the cooler is halfway full, place the data logger probe in the center
of the vaccines, keeping the display out of the cooler.
• Cover the vaccines with another two-inch layer of insulating material.
• Fill the remaining space in the cooler with frozen water bottles.
• Close the lid of the cooler securely and attach the data logger display and
a temperature log to the top of the lid to record and monitor the
temperature during transport.
• Use the vaccine transport log to record the time and temperature inside
of the storage unit at the time the vaccines are removed.
• If vaccines are kept in a transport container for longer than an hour,
record the temperatures hourly.
• As soon as the destination site is reached check and record the vaccine
temperature.
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• Place the vaccines in a freezer that maintains a temperature range
between -58°F and +5°F (-50°C and -15°C).
• Document the time and temperature the vaccine was removed from the
transport container and placed in the alternate storage unit.
• Immediately contact the vaccine manufacturer for viability data and
guidance when frozen vaccine has been exposed to a temperature above
+5°F (-15°C). Do not discard the vaccine without contacting the
manufacturer. Viability determination will be made on a case-by-case basis.
• Contact the RE with the viability determination from the manufacturer.
Figure 3-3 illustrates proper vaccine packing for transport during
emergencies when portable refrigerators and/or freezers are not available.
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Figure 3-3. Proper vaccine packing for transport during emergencies.
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Figure 3-3 (cont.). Packing refrigerated vaccines for transport during an
emergency.
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VI. Vaccine Transfers
The routine re-distribution of TVFC/ASN program vaccine, including the flu
vaccine and short-dated flu is not allowed. However, vaccine transfer is allowed
when necessary to avoid vaccine loss (i.e., if a provider’s storage unit is
overstocked, if the provider withdraws, is suspended, or terminated from the
TVFC/ASN programs). If a transfer must
occur, a “TVFC/ASN Vaccine Transfer
Authorization Form,” stock no. EC-67,
must be completed to receive approval
prior to conducting vaccine transfers.
Note that electronic “TVFC/ASN Vaccine
Transfer Authorization Form” must be
signed by the primary coordinator, backup
coordinator, or signing clinician.
The vaccine transfer can then be approved if the TVFC/ASN programs PIN of
where the vaccine is being transferred to is available. The transfer information
must be documented and tracked in VAOS. Once transfer requests are
submitted in VAOS, the RE receives the transfer request and the “TVFC/ASN
Vaccine Transfer Authorization Form” is available pre-populated with all
pertinent information for the transfer.
To conduct a vaccine transfer, the clinic transferring the vaccine must
complete the following:
• Ensure that the vaccine transfer is occurring for one of the
following reasons:
• Short-dated vaccine
• Withdrawal, suspension, or termination of a clinic from the TVFC/ASN
programs, or
• Other (emergency situations)
NOTE:
If a vaccine transfer must
occur, a “TVFC/ASN Vaccine
Transfer Authorization
Form”, stock no. EC-67,
must be uploaded to VAOS to
receive DSHS PHR approval.
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• The primary coordinator, backup coordinator, or signing clinician must
complete and sign the “TVFC/ASN Vaccine Transfer Authorization Form,”
stock no. EC-67 and agree that the vaccine will be transferred in
accordance with TVFC “Vaccine Storage and Handling Guidelines” to
ensure the proper cold chain will be maintained throughout the transfer
process. Each vaccine to be transferred must be listed on a separate row
on the TVFC/ASN “Vaccine Transfer Authorization Form,” stock no. EC-67
and must include the following:
• Vaccine type
• National Drug Code (NDC)
• Lot number
• Expiration date
• Number of doses being transferred.
• Upload the completed “TVFC/ASN Vaccine Transfer Authorization Form,”
stock no. EC-67, to VAOS. For emergency situations, call the RE prior to
uploading the form. The RE may also request the form be emailed or
faxed to them.
• The DSHS PHR will approve or deny the transfer within two business
days. VAOS will auto deny transfers after two weeks.
• The RE must ensure that the vaccine is packaged using proper cold chain
management as detailed in Section V – Vaccine Storage and Handling,
subsection H – Cold Chain Management and Vaccine Transport and a
certified, calibrated data logger is enclosed with the vaccine.
• Include a copy of the VAOS Transfer Form in the transfer package.
The VAOS Transfer Form can be printed after the transfer is conducted
in VAOS.
• After the vaccine transfer has been approved, the provider requesting the
transfer must download the “TVFC/ASN Vaccine Transfer Form” from
VAOS, fill out the form and upload the form into VAOS.
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The TVFC/ASN program clinic taking possession of the vaccine must keep
the “TVFC/ASN Vaccine Transfer Authorization Form,” stock no. EC-67, on
file for a minimum of five years must be easily available.
VII. Vaccine Borrowing
Vaccine borrowing is the utilization of ASN program vaccines TVFC/ASN
program vaccines as a replacement system for filling the vaccine needs of
non-TVFC/ASN-eligible patients.
The CDC requires that state Immunization programs enhance oversight of all
vaccine borrowing within TVFC/ASN program sites. As such, the TVFC/ASN
programs enforce a policy of not allowing vaccine borrowing between
TVFC/ASN and ineligible TVFC/ASN program patients.
All TVFC/ASN-enrolled sites are expected to
maintain an adequate inventory of vaccine for both
TVFC/ASN-eligible and privately insured patients.
Vaccines supplied by the TVFC/ASN programs
must not be provided to an ineligible patient.
Undocumented borrowing and administering of
TVFC/ASN program vaccines to an ineligible
patient is considered fraud. TVFC/ASN program
vaccines must not be used as a replacement
system for filling the vaccine needs of a privately
insured patient. For example, TVFC flu vaccine must not be administered to
privately insured patients even if TVFC flu vaccine arrived in the office prior
to the arrival of the privately purchased flu vaccine.
If a TVFC dose is accidentally administered to a privately insured patient or
an ASN patient, the following steps must be completed.
• Document the incident by completing the “TVFC/ASN Vaccine Borrowing
Form,” stock no. EF11-14171. Each TVFC/ASN vaccine administered to an
ineligible patient must be listed on a separate row on the form.
NOTE:
All TVFC/ASN-
enrolled sites must
maintain an
adequate inventory
of vaccine for both
TVFC/ASN-eligible
and privately
insured patients.
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• Report the incident by faxing or emailing a copy of the “TVFC/ASN
Vaccine Borrowing Form,” stock no. EF11-14171, to the RE within 24
hours. Adherence to HIPAA guidelines is mandatory when faxing this
form. The “TVFC/ASN Vaccine Borrowing Form,” stock no. EF11-14171,
must be kept as part of the TVFC/ASN programs record for a minimum of
five years and be made easily available.
• Replace the vaccine immediately with privately purchased vaccine and
account for the replacement in VAOS.
It is the responsibility of the staff at a TVFC/ASN-enrolled site to ensure that
all staff members are familiar with TVFC/ASN program requirements.
Adequate vaccine supply must be maintained in accordance with the clinic’s
patient population (TVFC, ASN and privately insured patients).
The TVFC/ASN program vaccine and private vaccine must be kept separate
and clearly labeled as such. All vaccine usage must be tracked and all doses
of TVFC/ASN program vaccine must be accounted for in VAOS.
Continued non-compliance with TVFC/ASN program policies and procedures
may be considered fraud and abuse. Referral may be made to the CMS
Medicaid Integrity Group (MIG) Field Office.
VIII. Reporting Requirements
The TVFC program requires the monitoring of refrigerators and freezers
containing TVFC program vaccines, vaccine inventory and vaccine usage.
All reports should be submitted in VAOS. If internet access is not available,
contact your RE and coordinate report submission.
All records related to the TVFC program are required to be maintained for
five years and made easily accessible.
The following documents must be completed in VAOS between the first and
seventh of each month, as well as each time an order is placed. The following
documents must be completed in VAOS or submitted to the RE.
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These records include the following:
• Temperature Logs
• Doses Administered
• Physical Inventory
• Receipt of Vaccine Shipments (if applicable)
• Vaccine Transfers (if applicable)
• Receipt of Vaccine Shipments (if applicable)
• Vaccine Transfers (if applicable): Equivalent to the “TVFC/ASN Vaccine
Transfer Authorization Form,” stock no. EC-67
• Doses administered: Equivalent to the “Monthly Biological Report Form,”
stock no. C-33
• Physical inventory: Equivalent to the “Monthly Biological Report Form,”
stock no. C-33 and
• Any other reports or required documents.
NOTE: Temperature recording forms are required to be submitted to your
RE or in VAOS between the first and seventh of each month, as well as each
time an order is placed.
Failure to submit required documents will automatically prevent ordering
until the documents are uploaded in VAOS. Clinic staff must ensure that all
reports are completed and submitted in VAOS by the required due dates.
All forms are included in the TVFC/ASN program “Provider Manual” in the
Forms section, as well as under TVFC Forms and Publications on the DSHS
website at www.dshs.texas.gov/immunize/tvfc/publications.aspx.
If internet access is unavailable, required reporting must be submitted to the
RE using TVFC/ASN program forms. Providers should contact their RE and
coordinate the submission of required reports.
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A. Vaccine Ordering for Providers without Internet Access
Monthly Biological Report, stock no. C-33
Doses administered should be documented in VAOS. This includes vaccine
received, doses administered, vaccine transferred, vaccine loss and on-hand
physical count. The “Tally and Physical Count” report in VAOS may be used
to help document vaccine management.
Qualified clinics that participate in the ASN program are required to
distinguish between their adult and pediatric vaccines and order and report
adult vaccines separately from TVFC pediatric vaccines.
Biological Order Form, stock no. EC-68-1
The “Biological Order Form” is used to order vaccines. All vaccines must be
ordered to bring the clinic up to their pre-determined MSL. For orders above
the suggested quantity, an explanation is required in the comment section.
Temperature Recording Form, stock no. EC-105
A “Temperature Recording Form” is to be maintained on all refrigerators and
freezers that store TVFC/ASN vaccine (including temporary day storage
units). A Fahrenheit, stock no. EC-105RF and EC-105FF, or Celsius, stock no.
EC-105RC and EC-105FC, form is required to be used to monitor
temperatures.
All TVFC/ASN program vaccines are required to always be maintained at
proper storage temperatures. To ensure proper temperatures are
maintained, the TVFC/ASN program requires the recording of refrigerator
and/or freezer temperatures twice daily for all units that store TVFC/ASN
vaccine. The minimum and maximum temperatures are to be recorded in the
morning.
Results of each check must be documented on the temperature recording
form and the form must be initialed by the staff member conducting the
check. Instructions for completing the “Temperature Recording Form” are
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listed on the top of the form. In the event of a temperature excursion,
immediate notification to the RE is necessary and must include the following
information on page 3 of the “Temperature Recording Form”:
• Date and time of event
• Storage unit temperature
• Room temperature
• Name of person completing the report
• Description of the event
• Action taken, including the instructions and procedures given by the RE
and the individual spoken to and
• The results.
All documentation regarding temperature deviations must be retained for
review during TVFC Compliance Visits and Unannounced Storage and
Handling Visits. An example of the “Vaccine Storage Troubleshooting Record”
can be found in the Forms section of this manual.
The following reports must be completed in VAOS:
• Temperature Logs
• Receipt of vaccine shipments (if applicable)
• Vaccine Transfers (if applicable)
• Doses Administered
• Physical Inventory and
• Vaccine loss (if applicable).
CHAPTER 4: BILLING AND ADMINISTRATION
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CHAPTER 4: BILLING AND ADMINISTRATION
I. Billing for Vaccine
Clinics enrolled in the TVFC program are prohibited from charging any
TVFC-eligible child for the cost of vaccines. TVFC program vaccines are
provided at no cost to clinics to vaccinate eligible children. Charging for the
cost of vaccines supplied by the TVFC program constitutes fraudulent
behavior. Fraud in the TVFC program will be handled in the same manner as
Medicaid fraud.
Private clinics may not refer a TVFC-eligible child to another health care facility
for TVFC program vaccines if the clinic has already accepted that child into
the practice as their patient, unless directed by DSHS.
II. Administration Fee
Sites are required to enroll in the TVFC program
to obtain vaccines at no cost to vaccinate
TVFC-eligible children, including Medicaid and
CHIP children. A fee for administering TVFC
vaccine to TVFC-eligible children may be charged.
The maximum administration fee for TVFC vaccine
is $13.75 per dose.
Medicaid and CHIP children must not be charged the administration fee for
receiving vaccines. For Medicaid children, the clinic site must accept the
reimbursement for immunization administration fee set by the state Medicaid
agency or the contracted Medicaid health plans.
Sites are reimbursed the lesser of the billed amount or the maximum
allowable fee. The state Medicaid agency may have the discretion to pay an
administration fee up to the regional maximum amount.
NOTE:
The maximum
administration fee
for TVFC vaccine is
$13.75 per dose.
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TVFC sites that choose to bill a vaccine administration fee to non-Medicaid
patients after the date of service must issue only a single bill to the patient
within 90 days of the administration of the vaccine. Sites can continue to bill
for other charges such as office visits or labs. As usual, unpaid
administration fees may not be sent to collections and the sites must not
refuse to vaccinate an eligible child whose parents have unpaid vaccine
administration fees.
Children 0-18 years of age who are enrolled in Medicaid as their secondary
insurance are eligible to receive TVFC program vaccines.
As stated in the “Texas Medicaid Provider Procedures Manual,” clinics should
bill their usual and customary fee except for vaccines obtained from the
TVFC program.
For more information on Medicaid reimbursement, please refer to the “Texas
Medicaid Provider Procedures Manual” located at
https://www.tmhp.com/resources/provider-manuals.
Children 0-18 years of age who are enrolled in CHIP are eligible to receive
TVFC program vaccines from active CHIP participating sites; however,
TVFC clinic sites must bill CHIP for the administration of a vaccine to a
CHIP-enrolled child. For more information on CHIP reimbursement, please
refer to the CHIP Provider Manual located at
www.texaschildrenshealthplan.org/for-providers/provider-resources.
Vaccines are required to be available to all TVFC-eligible children. Services
cannot be denied due to the parent’s or guardian’s inability to pay the
administration fee and the parent or guardian must not be sent to
collections. Penalties for the inability to pay administration fees must not
be charged.
Visit www.cdc.gov/vaccines/programs/vfc/providers/index.html for additional
information on the CDC VFC statutory requirements for the VFC program
vaccine administration fee.
CHAPTER 5: PROGRAM EVALUATION
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CHAPTER 5: PROGRAM EVALUATION
I. Standards for Childhood Immunizations
The National Vaccine Advisory Committee (NVAC), in collaboration with the
Ad Hoc Working Group for the Development of Standards for Pediatric
Immunization Practices developed a set of standards as to what constitutes
the most essential and desirable immunization policies and practices. The
DSHS website has the full article listed for reference. The standards are
listed below.
• Immunization services are readily available.
• No barriers or unnecessary prerequisites to the receipt of vaccines exist.
• Immunization services are available free or for a minimal fee.
• Providers utilize all clinical encounters to screen and, when indicated,
immunize children.
• Providers educate parents and guardians about immunization in general
terms.
• Providers question parents or guardians about contraindications and,
before immunizing a child, inform them in specific terms about the risks
and benefits of the immunizations their child is to receive.
• Providers follow only true contraindications.
• Providers administer simultaneously all vaccine doses for which a child is
eligible at the time of each visit.
• Providers use accurate and complete recording procedures.
• Providers co-schedule immunization appointments in conjunction with
appointments for other child health services.
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• Providers report adverse events following immunization promptly,
accurately and completely.
• Providers operate a tracking system.
• Providers adhere to appropriate procedures for vaccine management.
• Providers conduct semi-annual audits to assess immunization coverage
levels and to review immunization records in the patient populations
they serve.
• Providers maintain up-to-date, easily retrievable medical protocols at all
locations where vaccines are administered.
• Providers operate with patient-oriented and community-based approaches.
• Vaccines are administered by properly trained individuals.
• Providers receive ongoing education and training on current immunization
recommendations.
II. Common Site Visit Structures: Compliance, IQIP,
Storage and Handling
By signing the TVFC program agreement, the signing clinician agrees to
allow DSHS or DSHS quality assurance and improvement (QAI) contractors
to conduct site visits at least every other year at their site. DSHS PHR and
LHD clinics participating in the TVFC program will receive a scheduled site
visit annually from a DSHS PHR reviewer. In some instances, site visits may
be conducted by staff from an LHD. Newly enrolled sites will receive a site
visit between six to 12 months after initial enrollment.
During a TVFC program site visit, the reviewer will need access to the
following:
• Space to work
• Power source
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• Internet connectivity (if available)
• Access to patient records
• “Temperature Logs” or data for the last three months, or longer if
deficiencies are found
• “TVFC/ASN Vaccine Borrowing Form,” stock no. EF11-14171, for the
previous 12 months
• Circuit breaker
• Admitting and billing personnel to clarify eligibility screening and billing
process
• All vaccine storage units where TVFC program vaccine is stored
Site visits are conducted using different structures to ensure that each site is
being evaluated based on the eligible populations served. These structures
are described on the next pages.
A. TVFC Compliance Site Visits
The purpose of the compliance visit is to assess, support and educate the
staff regarding TVFC program policies and procedures, not to critique.
This visit consists of a questionnaire. If areas of concern are identified, the
RE will provide a follow-up call or visit to assist the clinic with any changes
or questions.
Clinic staff will be contacted prior to a
scheduled compliance site visit and will
receive a confirmation letter via email or fax
that includes the date, time, materials
needed and summary of the site visit
process. It is required that the signing
clinician, primary vaccine coordinator, or
backup vaccine coordinator be present at all
site visit related activity.
NOTE:
The purpose of
compliance visits is to
assess, support and
educate the site
regarding TVFC program
policies and procedures.
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TVFC Compliance Follow-up to the Site Visit
Upon completion of the site visit, the reviewer will discuss the outcomes of
the visit with the vaccine coordinator. The discussion will include a review of
the site visit findings and a formal follow-up plan with a timeline that
addresses non-compliance issues or improvement opportunities.
The signing clinician, primary vaccine coordinator, or backup vaccine
coordinator are required to attend the site visit. At the end of the site visit,
the staff that were present at the site visit must print and sign their name as
it is listed in the Provider Education and Assessment Reporting (PEAR)
“System on an Acknowledgement of Receipt” (AR) form following the visit.
The AR is the document that attests to the fact that a site visit was
completed, the results of the visit were received and that both the reviewer
and the vaccine coordinator understand all non-compliance issues identified
and the actions necessary to address them. The RE will conduct all required
follow-up activities. The purpose of follow-up activities is to ensure that
areas for improvement identified by the RE or DSHS contractor are
understood by the site’s staff and corrective actions have been identified and
implemented. Follow-up activities are conducted as necessary to address all
issues and depend on the severity of the non-compliance issues and the
follow-up action plan.
Follow-up activities can include but are not limited to the following:
• Visiting the clinic to observe corrective actions
• Calling the vaccine coordinator at the clinic
• Sending a letter to address the deficient items identified during the site
visit
• Determining the staff’s compliance with the corrective action plans,
if applicable.
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The RE works with clinic staff on non-compliance issues by providing
education and guidance regarding corrective actions, including monitoring.
If a site exhibits habitual non-compliance and does not follow corrective
actions in response to education, the vaccine ordering privileges may be
suspended. If non-compliance continues, termination from the TVFC
program may be implemented.
TVFC Compliance Site Visit Only
This visit will be conducted for those sites that have not been selected to
participate in the IQIP portion of the visit. Only the TVFC compliance visit is
conducted. The purpose of this visit is to assess, support and educate the
site regarding TVFC policies and procedures.
B. Immunization Quality Improvement for Providers (IQIP)
Site Visits
IQIP site visit purpose is to review procedures and clinic practices so that the
TVFC program can assist in creating strategy improvement plans. This visit
includes an IQIP visit and a TVFC questionnaire. A core component of this
visit is to focus on assessing provider-level vaccination coverage rates using
the data reported to ImmTrac2. It is required that the signing clinician,
primary vaccine coordinator, or backup vaccine coordinator be present
during the IQIP visit.
Currently TVFC program providers who qualify for an IQIP visit will get a
visit termed as a "Combination Site Visit" which will include their annual
compliance visit simultaneously.
During the IQIP site visit, staff at the facility will receive an IQIP Plan that
will include quality improvement strategies, ImmTrac2 resources and
instructions on action items to be implemented at the facility. Once this
portion of the site visit is completed, the site reviewer will transition into the
TVFC Compliance portion. Visit Immunization Quality Improvement for
Providers Program | Texas DSHS for more information on IQIP.
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IQIP Site Visit Follow-up Activities
The Texas DSHS Quality Assurance and Improvement (QAI) team will
conduct all IQIP follow-up activities. Technical assistance and support are
given virtually at two, six and 12-month intervals to assist providers in
staying on course with their strategy implementation plans. At the end of 12
months, a final discussion of the strategy plan progress and coverage rates
are measured again to evaluate effectiveness.
C. Unannounced Storage and Handling Visits
Unannounced storage and handling visits may be conducted to serve as
“spot checks” for proper vaccine storage and handling. Unannounced visits
focus exclusively on vaccine storage and handling.
The RE will prioritize sites for unannounced visits based on the
following criteria:
• Vaccine loss
• Improper storage of vaccine
• Improper documentation on “Temperature Logs”
• Vaccine orders are inconsistent with population profile data
• Newly enrolled sites
• Determination of the clinic’s compliance with corrective actions.
Vaccine storage and handling issues are identified and addressed
immediately during site or unannounced visits. The staff are expected to
make onsite corrections to safeguard the vaccine.
• The signing clinician, primary vaccine coordinator, or backup vaccine
coordinator are required to attend the unannounced storage and handling
site visit. At the end of the USH site visit, the staff that were present
must print and sign their name as it is listed in the PEAR AR form
following the visit.
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III. TVFC Program Electronic Medical Records (EMRs)
Sites with EMRs have the following immunization record review options, one
of which must be available at the time of the visit:
• A dedicated staff member who can login to the EMR and sit with the field
reviewer throughout the record review process to access EMR
immunization and eligibility records.
• Print outs from the EMR of the immunization records and documentation
of the child’s eligibility. The immunization records must include all
immunization histories, including records from other clinic sites.
NOTE: It is not acceptable to have a site staff member login and then turn
the EMR screens over to the reviewer; the staff member is required to be
present. The TVFC program or the DSHS QAI contractor will not pay for, nor
reimburse clinics for the copies when the staff chooses to print out
immunization records from their EMR system.
IV. TVFC/ASN Provider Satisfaction Surveys
TVFC/ASN-enrolled providers are the best sources of information for
evaluating which aspects of the programs are working or not working as
planned. In addition to evaluating operational components, surveys are used
to gather information on educational needs of enrolled sites or their
responses to education provided. Findings may determine which quality
improvement projects may be undertaken. Enrolled sites can expect at least
two surveys yearly.
A. Annual TVFC/ASN Satisfaction Survey
The TVFC/ASN programs conduct an annual TVFC/ASN Provider Satisfaction
Survey to help identify areas of the TVFC/ASN programs that are working
well and those that may need improvement. The survey will be conducted
during re-enrollment and the results will be collected and submitted to
program staff for review. Questions in the survey will address clinic staff
satisfaction with the current vaccine ordering and shipping practices,
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TVFC/ASN program policies and procedures, reporting requirements,
customer service provided by TVFC/ASN program staff at the state, regional
and local levels, as well as the communication methods of the TVFC/ASN
programs. The survey will also ask TVFC/ASN-enrolled sites about their use
of the Texas Immunization Registry (ImmTrac2) in daily practice.
B. Site Visit Assessment Survey
The site visit assessment survey is conducted following TVFC compliance
visit or TVFC IQIP and compliance combination visit. An email containing a
link to an online survey is sent to the primary vaccine coordinator after a site
visit is conducted. It allows the clinic staff to provide feedback about their
experiences during the visit.
CHAPTER 6: FRAUD AND ABUSE
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CHAPTER 6: FRAUD AND ABUSE
I. Fraud and Abuse
As the complexity of immunizations and immunization-related programs
grow, sites enrolled in TVFC/ASN program may become more vulnerable to
unintentionally committing acts that could be construed as fraud and/or
abuse. Fraud and abuse, whether intentional or not, are subject to all federal
fraud and abuse laws.
II. Definitions
A working understanding of what constitutes fraud and abuse is critical for
all persons working in the TVFC/ASN programs. The following are definitions
of terms related to fraud and abuse.
Fraud - An intentional deception or misrepresentation made by a person
with the knowledge that the deception could result in an unauthorized
benefit to himself or another person. It includes any act that constitutes
fraud under applicable federal or state laws.
Abuse - Practices that are inconsistent with sound fiscal, business, or
medical practices and result in an unnecessary cost to the Medicaid Program
(and/or including actions that result in an unnecessary cost to the TVFC
program, a health insurance company, or a patient) or in reimbursement for
services that are not medically necessary, or that fail to meet professionally
recognized standards for health care. It also includes recipient practices that
result in unnecessary costs to the Medicaid Program.
Oversight - The act of training, monitoring and providing assistance to clinic
staff on TVFC/ASN program policies and procedures.
Enforcement - Identifying rules and policy violations and ensuring
corrective action is taken.
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Termination - Action taken when a site or signing authority is no longer
eligible for the TVFC program due to fraud, abuse, or non-compliance.
Waste - The careless, inefficient, or unnecessary use of TVFC
program resources.
III. Examples
Fraud or abuse can occur in many ways. Some types of fraud and abuse are
easier to prevent or detect than others. All staff at TVFC-enrolled sites
should familiarize themselves with the examples below, as they illustrate
common practice errors that could result in fraud or abuse allegations.
This list provides examples only and should not be considered an
exhaustive list of situations that would constitute fraud or abuse.
• Provide TVFC vaccine to ineligible children
• Sell or otherwise misdirect TVFC vaccine
• Bill a patient or third party for TVFC vaccine (other than
administration fees)
• Charge more than $13.75 for administration of a TVFC vaccine to an
eligible child
• Failure to meet licensure requirements for enrolled clinicians
• Deny TVFC-eligible children TVFC vaccine because of the inability to pay
the administration fee
• Send a parent or guardian to collections or charge additional fees for
non-payment of the administration fee
• Failure to implement TVFC program enrollment requirements
• Failure to screen for and document TVFC eligibility at every visit
• Failure to maintain TVFC records for five years
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• Failure to fully account for TVFC vaccine
• Failure to properly store and handle TVFC vaccine
• Order TVFC vaccine in quantities or patterns that do not match population
profile or otherwise involve over-ordering of TVFC doses
• Loss of TVFC vaccine due to negligence
IV. Failure to Comply with TVFC Program Requirements
Enrolling in the TVFC program is an agreement to comply with all the
requirements of the program. Lack of adherence to the TVFC program
requirements by an enrolled site could lead to fraud and abuse of the TVFC
program by that site. Non-compliance with the TVFC program requirements
may occur due to an unintentional lack of understanding of the
requirements. Behavior may also be intentional. If the non-compliance
appears intentional and the clinic staff or signing authority has received
financial benefits from the behavior, the situation will result in immediate
referral for investigation of suspected TVFC fraud and abuse.
V. Fraud and Abuse Prevention
The TVFC program actively works with enrolled clinics to help prevent fraud
and abuse in the TVFC program. The best methods to prevent fraud and
abuse are strong educational components discussed during the initial
enrollment process and during the TVFC compliance visits. Both occasions
provide the opportunity to identify and prevent situations that may develop
into fraud and abuse.
VI. Reporting Fraud and Abuse
Suspected fraud or abuse can be reported to the TVFC program or the
RE via email, telephone, fax, or letter. Furthermore, newspaper articles
and internet pages that promote potential fraudulent situations are
also investigated.
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The RE and DSHS QA contractors must report all cases of alleged or
suspected fraud or abuse. Reports received by the DSHS Immunization
program in any form that merit further investigation may be referred to the
CMS, Medicaid Integrity Group (MIG) Field Office. The state Medicaid agency
will conduct preliminary investigations and, as warranted, refer appropriate
cases to the state’s Medicaid Fraud Control Unit following the Federal
Regulatory scheme at 42 CFR section 455.15 and 42 CFR section 455.23.
CHAPTER 7: DOCUMENTATION REQUIREMENTS
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CHAPTER 7: DOCUMENTATION
REQUIREMENTS
I. Vaccine Record Keeping Requirements
The 1986 National Childhood Vaccine Injury Act (NCVIA) requires all
vaccinators nationwide to record the following specific information in the
medical record each time a vaccine is administered:
• Name of vaccine administered
• Date vaccine was administered (month, day, year)
• Date VIS was given
• Publication date on VIS
• Name of vaccine manufacturer
• Vaccine lot number
• Name and title of the health care professional administering the
vaccine and
• Address of the clinic where the vaccine was administered
If needed, the DSHS Immunization program provides immunization records
that are designed to capture all information that is required when a vaccine
is administered. Immunization records for clinics, the “Vaccine Information
Documentation Form,” stock no. C-100 and clients, “Personal Immunization
Record Card,” stock no. C-102, can be ordered free-of-charge from DSHS
(See Chapter 11: Ordering Forms and Literature). The TVFC program
suggests the following recommendations regarding record keeping:
• Designate an immunization staff member to answer immunization
questions for staff and parents.
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• File patient records, keeping the immunization record and “TVFC Patient
Eligibility Forms,” stock no. C-10, together.
• Place immunization records at the front of each patient’s chart and make
immunizations a priority.
• Encourage parents to bring their children’s immunization records with
them to facilitate complete documentation in the child’s record of
previous immunization history.
• If a child presents with no immunization record, obtain the history
through the Texas Immunization Registry (ImmTrac2), or call previous
medical facility to obtain the history.
• Empower all staff to become “Immunization Advocates” and have them
assess each child’s immunization status at every encounter.
• Give a personal immunization record to each vaccine recipient showing
the date (month, day and year) of when each vaccine was administered.
Copies of all TVFC/ASN program documents must be maintained for five
years and made available on request by the TVFC/ASN programs, the RE, or
the DSHS QA contractor.
II. The Texas Immunization Registry (ImmTrac2)
ImmTrac2 is operated by the DSHS Immunization program and is an
important component of Texas’ strategy to improve immunization
coverage rates.
Texas Health and Safety Code Sec. 161.007-161.009 requires all medical
providers and payors to report all immunizations administered to clients who
are 17 years of age and younger to ImmTrac2 within 30 days of
administration of the vaccine.
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ImmTrac2 is designed to consolidate immunization records from multiple
sources throughout the state including:
• Electronic data exchange with ImmTrac2 from Electronic Health Record
(EHR) systems
• Registered organizations have easy access to immunization records for
participating clients
• Forecasts immunizations coming due or past due
• Various reports available for ImmTrac2 users including “Reminder” and
“Recall” capabilities
Adults may also consent to ImmTrac2, which stores their immunization
information for a lifetime. Individuals who turn 18 years old and were
participating in ImmTrac2 as a minor, must sign an adult consent form by
their 26th birthday to keep their immunization information in ImmTrac2.
At the patient’s 18th birthday, the immunization record stored in ImmTrac2
will be “hidden” from view until an adult consent is signed. If a patient does
not sign an adult consent, the record will be deleted from ImmTrac2 on the
patient’s 26th birthday.
As a registered user of ImmTrac2, medical professionals can confirm
whether a patient is in ImmTrac2 and can consent individuals in ImmTrac2
who desire to participate.
TVFC-enrolled sites must register as an authorized organization with
ImmTrac2 by completing an online form. Call ImmTrac2 Customer Support
line at 800-348-9158 or visit www.dshs.texas.gov/immunization-
unit/immtrac2-texas-immunization-registry to register or for more
information about ImmTrac2.
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A. Reporting Vaccine Eligibility in ImmTrac2
Eligibility for the TVFC and ASN programs must be reported in Immtrac2
using specific vaccine eligibility codes. The following codes must be used
when reporting in ImmTrac2 online or by data exchange (HL7):
• V01 for Private Pay/Insurance: Patient is <19-years-old
• V02 for Medicaid: Patient is <19-years-old
• V03 for No Insurance: Patient is <19-years-old
• V04 for American Indian/Alaskan Native: Patient is <19-years-old
• V05 for Underinsured, FQHC/RHC/Deputized: Patient is <19-years-old
• TXA01 for CHIP: Patient is <19-years-old
• TXA02 for Underinsured, Not FQHC/RHC/Deputized: Patient is
<19-years-old
• TXA03 for 19-Year-Old Completing Series: Patient = 19-years-old
• TXA04 for Adult, No Insurance: Patient is >= 19-years-old
• TXA05 for Adult, Underinsured: Patient is >= 19-years-old
• TXA06 for Adult, Private Pay/Insurance: Patient is >= 19-years-old
Underinsured
B. Reporting Requirements During Disaster Declaration
In the event of a disaster declaration, providers are required to report
Antivirals, Immunizations and other Medications (AIM) for disasters and
emergencies to ImmTrac2. Disaster-related AIMs are required to be kept in the
registry for five years following the end of the disaster declaration. Visit the
Texas Administrative Code Title 25 Part 1 Chapter 100 for more information
regarding the reporting of AIMS and other immunizations to ImmTrac2.
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III. Addressing Vaccine Hesitancy
Maintaining public confidence in immunizations is critical for preventing a
decline in vaccination rates that can result in disease outbreaks. While most
parents believe in the benefits of immunizations and have their children
vaccinated, some have concerns about the safety of vaccines. The concerns
about vaccine safety are preventing some parents from having their children
immunized.
Overcoming barriers requires both knowledge and interpersonal skills on the
part of the medical staff. Medical staff that administer vaccines should
understand vaccines, up-to-date recommendations and reliable resources to
direct parents and patients to find accurate information. Also, vaccinators
must have the skills necessary to deal with fears and misconceptions about
vaccines and the ability to provide a supportive and encouraging
environment for patients.
When a parent or patient initiates the discussion regarding a vaccine
concern, discuss the specific concern and provide factual information.
The VIS provides an outline for discussing vaccine benefits and risks.
Reinforce key points regarding each vaccine, including safety and emphasize
risks encountered by unimmunized children. Parents should be informed
about state laws pertaining to school or childcare entry, which might require
unimmunized children to stay home from school during outbreaks.
Documentation of these discussions in the patient’s record might reduce
any potential liability if a vaccine-preventable disease occurs in the
unimmunized patient.
IV. Vaccine Adverse Events
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine
safety surveillance program co-sponsored by the Food and Drug
Administration (FDA) and the CDC. VAERS aims to detect possible signals of
adverse events associated with vaccines. VAERS collects and analyzes
information from reports of adverse events that occur after the
administration of U.S.-licensed vaccines.
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Reports of adverse events are welcome from all concerned individuals,
including:
• Patients
• Parents
• Health care professionals
• Pharmacists and
• Vaccine manufacturers
Health care providers are encouraged to report all clinically significant
adverse events after vaccination to VAERS, even if it is unclear whether the
vaccine caused the event. Federal law also requires providers to report
certain adverse events found in the VAERS “Table of Reportable Events”.
Some reporting requirements are vaccine-specific. Generally, reporting is
also required for events described in a manufacturer’s package insert as
contraindications to additional doses of vaccine and for acute complications
or sequelae including death.
Clinic staff should use the VAERS Reporting Website to report all adverse
events after vaccination directly to VAERS. Be prepared with all information
needed for the VAERS reporting form, including patient and provider detail,s
adverse event description and outcome and vaccine details such as
manufacturer, lot number and injection site.
For a serious adverse event (one that causes life-threatening illness,
hospitalization, prolongation of an existing hospitalization, permanent
disability, or death), a copy of the VAERS report must be submitted to your
RE. This can be done most easily using the “pdf upload” option on the
VAERS website at vaers.hhs.gov/.
CHAPTER 8: OFF-SITE AND MASS VACCINATION CLINICS
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CHAPTER 8: OFF-SITE AND MASS
VACCINATION CLINICS
A. Vaccine Ordering for Off-Site and Mass Vaccination Clinics
Off-site and mass vaccination clinics may be set up for seasonal vaccines,
such as influenza, to protect a large group of patients.
Routine transport of vaccine is not recommended due to the risk of
compromising the cold chain and vaccine viability. However, because most
temporary mass clinics typically require vaccine transport on the day of the
clinic, these temporary clinics require enhanced storage and handling
practices. Providers that conduct off-site and mass clinics are not allowed to
operate outside of their jurisdiction. If you are unsure about your
jurisdictional boundaries, please contact your RE.
Clinic staff must develop mass vaccination protocols to ensure outreach
efforts meet all TVFC/ASN program requirements, including the following:
• Showing the established vaccine needs (e.g., provider profile)
• A schedule to include the date, location and estimated number of
vaccines expected to be administered for each off-site clinic
• A plan for overseeing vaccine ordering for each clinic site to ensure that
proper amounts of TVFC/ASN stock are transported on each clinic day
• The type of portable storage unit being used
• How the cold chain will be maintained from the beginning to the end of
the mass vaccination clinic
• Each site location must document temperatures on the “Temperature
Recording Form,” stock no. EC-105
The RE must review and approve a mass vaccination plan before initiation of
the mass vaccination clinics.
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Mass vaccinators where the enrolled site is not providing direct services and
other parties are involved with administering the vaccines, all parties
involved with implementing the clinics, including the signing clinician and
other groups directly administering the vaccine, must sign an agreement. A
written agreement must be attached to the TVFC/ASN programs agreement
detailing the responsibilities of each party involved.
B. Off-Site and Mass Vaccination Clinic Requirements
To ensure vaccine storage and handling for off-site and mass vaccination clinics
is managed properly, the following storage and handling practices are required.
• All TVFC/ASN vaccine must be ordered and shipped directly to a location
within the ordering clinic’s DSHS PHR.
• The vaccine must be properly transported, not shipped, to local schools or
other community sites where the mass vaccination clinics will be held.
• The total time for vaccine transport alone or vaccine transport plus clinic
workday must not exceed a maximum of eight hours (e.g., if transport
to an off-site clinic is one hour each way, the clinic may run for up to
six hours).
• Only amounts of vaccines that are appropriate, based on TVFC/ASN need,
should be transported to each scheduled clinic.
• Vaccine must be transported to and from the scheduled mass vaccination
clinic at appropriate temperatures and must be monitored by a data
logger that meets TVFC/ASN requirements as listed in Chapter 3:
VACCINE MANAGEMENT > V. Vaccine Storage and Handling > B. Data
Logger Requirements. The data logger’s display must be placed outside
the storage unit for continuous monitoring.
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• The vaccine being transported must be tracked to maintain accountability
for monthly reporting in VAOS. This includes the following:
• Vaccine type(s) and brand names
• Quantity of each type
• NDC numbers
• Lot numbers and
• Expiration dates
• Upon arrival at the clinic site, ensure the vaccine is stored to maintain the
appropriate temperature throughout the clinic day.
• Since the vaccine is at a temporary location, temperature data must be
reviewed and documented every hour during the clinic using a data
logger. The “Temperature Recording Form,” stock no. EC-105, may be
used to document hourly temperatures.
• After each clinic day, a physical count of the remaining vaccine must be
conducted and an assessment of temperatures must be performed before
placing vaccine back into storage units to prevent inadvertent
administration of vaccine that may have been compromised.
Vaccines exposed to temperature excursions must be separated in a
“Vaccine Quarantine Bag” and labeled “Do Not Use” until further information
can be gathered from the manufacturer(s). The vaccine should be kept at
appropriate temperatures until the viability determination is made.
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CHAPTER 9: ADULT SAFETY NET PROGRAM
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CHAPTER 9: ADULT SAFETY NET PROGRAM
I. Adult Safety Net (ASN) Overview
The Adult Safety Net (ASN) program began in 2003 as a Hepatitis B
initiative. In its 20 years of service, the ASN program has expanded its
vaccination services for uninsured adults aged 19 and older in Texas and has
evolved into one of the major factors in improving adult vaccination rates in
the state today. The program supplies adult vaccines to a network of more
than 600 providers with the support of the DSHS PHR and contracted LHD.
These organizations function as RE to ensure compliance with State and
Federal standards and effective vaccine distribution. Enrolled sites will
contact their REs for information and details about required ASN procedures.
II. ASN Eligible Facility Types
Clinic sites that are eligible to enroll in the ASN program include, but may
not be limited to, clinics that are formally recognized as one of the following:
• DSHS Public Health Regions (PHR)
• Local Health Departments (LHD)
• Federally Qualified Health Centers (FQHC)
• Rural Health Clinics (RHC)
• Federally Recognized Indian Tribes
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III. ASN Enrollment
The first step in becoming an ASN-enrolled site is completing the TVFC/ASN
program Agreement form. If assistance is needed, contact the DSHS
Immunization program or the RE. ASN-enrolled sites that are an FQHC or an
RHC must submit a copy of the CMS letter that designates the site as such.
All ASN-enrolled sites must agree to the policies and requirements included
in the TVFC/ASN program agreement. The TVFC/ASN program agreement
form includes basic information about the facility and signing clinician. The
agreement also outlines the responsibilities of clinic staff. Sites interested in
participating in ASN must enroll in ImmTrac2. Upon completion of
enrollment with ImmTrac2, the site will receive an ImmTrac2 organization
code. The signed “Provider Agreement” form and ImmTrac2 organization
code must be received and processed by the ASN program prior to the clinic
receiving state-funded vaccines.
IV. ASN Patient Eligibility
A. Eligibility Criteria
Only adults aged 19 years and older who are uninsured are eligible to
receive ASN program vaccines. Those with medical insurance, including
Medicare or Medicaid are not eligible to receive ASN program vaccines.
Those who are underinsured (have insurance that does not cover
immunizations) are only eligible to receive the COVID-19 vaccines.
Adults with private insurance that covers
vaccines are not eligible to receive ASN
program vaccines from ASN-enrolled sites,
but instead must be referred to their
medical home or other site that provides
immunizations, such as a pharmacy. Adults
who are enrolled with Medical Access
Program (MAP) are eligible to receive vaccines from ASN-enrolled sites.
Some ASN facilities may see patients who participate in Healthy Texas
Women (HTW) Program. HTW is considered insurance with limited services
NOTE:
Adults enrolled in MAP are
eligible to receive vaccines
from ASN-enrolled sites.
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and patients are not eligible to receive vaccines under the ASN program.
Visit www.healthytexaswomen.org for more information on the
HTW program.
An LHD, FQHC or RHC that provides comprehensive health care services to
adults with private insurance may continue to serve as the medical home for
their privately insured patients. However, private stock vaccine must be
purchased to vaccinate privately insured adults.
B. Nineteen-Year-Olds
Patients who are 19 years of age and who previously initiated a vaccination
series under the TVFC program but have not completed the series, may
complete the series using ASN program vaccines regardless of their current
health insurance status. If the dose is to complete the series, the patient is
eligible to receive the vaccines under the ASN program however, booster
doses are not eligible. The vaccine must be administered at a DSHS PHR or
LHD clinic. This provision only applies to patients that have not yet reached
their 20th birthday.
NOTE: A “series” in this case is specific to two doses of Hepatitis A (HepA);
three doses of Hepatitis B (HepB); two doses of Meningococcal Conjugate
(MCV4); two doses of Measles, Mumps and Rubella (MMR); and three
Tetanus, Diphtheria/Tetanus, Diphtheria, Pertussis (Td/Tdap). This policy
does not apply to Meningococcal B (MenB), Polio, Haemophilus influenzae
type b (Hib), or Influenza vaccines. This policy also does not apply to
booster doses.
C. Patient Eligibility Screening Record
Screening for patient eligibility is the foundation of clinic-level accountability.
Screening all adults at every immunization encounter and documenting
eligibility screening at every visit is the only way to ensure that ASN vaccine
is used only for ASN eligible adults. As such, full compliance on screening for
eligibility is required. In the event improper screening results in the
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administration of ASN vaccine to an ineligible adult, sites are responsible for
replacing the improperly used ASN vaccine with private stock. In this
instance, a “Vaccine Borrowing Form,” stock no. EF11-14171, is required to
be completed and submitted to RE.
Clinic sites are required to document the
eligibility of each adult receiving ASN
vaccine at every visit. During a patient’s
initial visit, the eligibility category must
be documented according to the ASN
program guidelines and updated during
each future visit.
Clinic sites may use the “Adult Eligibility
Screening Record,” stock no. F11-12842,
or electronically store patient
demographic information (must include
all information as contained on the “Adult
Eligibility Screening Record,” stock no.
F11-12842). Eligibility screening must be completed/updated for all adults at
every visit, including adults with a previous record on file.
Eligibility must be documented at every visit prior to vaccine administration.
Documentation of eligibility screening must include the following elements:
• Date of screening
• Patient’s name
• Patient’s date of birth
• Clinic name and
• Eligibility status for each visit
The “Adult Eligibility Screening Record” forms, stock no. F-11-12842, must
be kept on file with the patient’s record, for a minimum of five years after
the last date of service to the patient and must be easily retrievable.
NOTE:
Adult vaccines administered
to female veterans are
required to be reported
monthly to DSHS.
If no female veterans
received ASN vaccine the
previous month, the site
staff must report zero in
the survey.
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It is also acceptable for clinics to utilize an EMR system to capture and save
the information from the “Adult Eligibility Screening Record,” stock no.
F11-12842, if the EMR captures all the required eligibility elements.
D. Vaccine Services to Female Veterans
In accordance with Senate Bill 805 from the 87th Texas Legislature, Regular
Session, DSHS must collect and report the number of uninsured female
veterans who receive ASN program vaccines.
By the seventh of each month, all ASN-enrolled sites must document the
number of female veterans who received ASN program vaccines for the
previous month using the “Uninsured Female Veterans Reporting Form”
located online at www.dshs.texas.gov/immunize/ASN/publications.aspx. This
online survey is password protected. Clinic staff must contact the RE to
obtain the password for the online survey.
If no female veterans received ASN vaccine the previous month, clinic staff
must report zero in the survey.
V. ASN Vaccine Formulary
The ASN program supplies the following ACIP-recommended vaccines and
toxoids to enrolled sites.
• Coronavirus (COVID-19)
• Hepatitis A (Hep A)
• Hepatitis B (Hep B)
• Hepatitis A and Hepatitis B (Hep A-Hep B) combination
• Measles, Mumps and Rubella (MMR)
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• Meningococcal conjugate (MCV4)
• Tetanus and Diphtheria toxoids (Td)
• Tetanus and Diphtheria toxoids and acellular Pertussis (Tdap)
It may be necessary for the DSHS Immunization program to make changes
to the ASN vaccine listed based on available funding. Official information will
be distributed to all ASN-enrolled sites if changes to the vaccine formulary
are necessary. The COVID-19 vaccine will remain available to enrolled ASN
providers on a temporary basis and updates will be provided as they are
made available.
VI. Provider Enrollment Requirements
A. Specific Terms of Agreement
To participate in the ASN program, clinic staff must agree to follow all
program requirements. By signing the TVFC/ASN program agreement, the
office and all practitioners associated with the medical office agree to the
following:
• Submit a provider profile representing populations served by the
facility annually.
• Screen for and document ASN eligibility of all adults at each
immunization encounter.
• Administer ASN vaccine to uninsured adults 19 years of age or older.
• Comply with appropriate vaccination schedules, dosages and
contraindications that are established by the ACIP.
• Maintain all records related to the ASN program for at least five years and
upon request, make these records available for review.
• Immunize eligible adults with publicly supplied vaccine at no charge to
the patient for the vaccine.
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• Not charge an administration fee in excess of $25.00 per vaccine dose.
• Not charge an administration fee for the COVID-19 vaccine.
• Not deny administration of ASN vaccine to an eligible adult because of the
inability of the patient to pay the administration fee.
• Not send a patient to collections or charge additional fees for
non-payment of an ASN administration fee.
• Provide a copy of the most current VIS for each vaccine at the time
of administration.
• Comply with the ASN program requirements for vaccine management,
including ordering and proper storage and handling practices.
• Operate the ASN program in a manner intended to avoid fraud
and abuse.
• Participate in ASN site visits, including unannounced visits and other
educational opportunities, as required.
• Acknowledge that the DSHS Immunization program may terminate the
agreement at any time for failure to comply with established
requirements. If the agreement is terminated, the office and/or facility
agrees to return all ASN program vaccines.
• If a site voluntarily withdraws from the ASN program, the office/facility
agrees to return any unused vaccine, state-issued data loggers and
accompanying certificates of calibration within five days of withdrawal.
Prior to withdrawal, the clinic staff must complete a provider withdrawal
form and submit the form to the RE.
In jurisdictions where there are mass vaccinators enrolled, or circumstances
where the enrolled site is not providing direct services and other parties
are involved with administering the vaccines, all parties involved with
implementing the clinics, including the medical director and other
groups who are directly administering the vaccine, must sign the
“Provider Agreement”.
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There must be a written agreement attached to the TVFC/ASN program
“Provider Agreement” detailing the responsibilities of each party involved.
B. Initial Enrollment
The steps for initial enrollment into ASN are the same as the steps for initial
enrollment into TVFC. Those instructions can be found in the CHAPTER 1:
TVFC PROVIDER ELIGIBILITY AND ENROLLMENT > II: Provider Enrollment
Requirements > C. Initial Enrollment section of this manual.
C. ASN Enrollment Visit
The components of the ASN enrollment visit are the same as the
components of the TVFC enrollment visit. A description of the enrollment
visit can be found in the CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND
ENROLLMENT > II: Provider Enrollment Requirements > D. TVFC Enrollment
Visit section of this manual.
D. ASN Site Set-up
The components of the ASN site set-up are the same as the components
of the TVFC enrollment visit. A description of the enrollment visit can be
found in CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT > II:
Provider Enrollment Requirements > E. TVFC Site Set-up section of
this manual.
E. Vaccine Accountability
Vaccine accountability is a cornerstone of the ASN program and one of the
highest priorities for the DSHS Immunization program. When a clinic site
enrolls in the ASN program, they agree to the accountability requirements as
a condition of participation.
All ASN-enrolled sites must ensure the following:
• ASN program vaccines are administered only to eligible adults
• Vaccine loss and waste are minimized and documented
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• Fraud and abuse do not occur
• ASN vaccine inventory is accurately reported monthly
• Patients are screened at all immunization encounters for ASN eligibility
F. Provider Identification Number
A PIN will be assigned to the clinic upon initial enrollment into the
ASN program. Eligible sites currently enrolled in TVFC will use the same
TVFC PIN for participation in ASN.
See the CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT > II:
Provider Enrollment Requirements > G. Provider Identification Number
section of this manual for more information on PIN assignments.
G. Provider Change of Information
The requirements for clinic sites change of information notifications in ASN
are the same as those for TVFC. Those instructions can be found in the
CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT > II: Provider
Enrollment Requirements > G. Provider Change of Information section of
this manual.
Failure to properly update current clinic information may result in vaccine
delays and possible vaccine loss.
H. Annual Re-Enrollment
ASN re-enrollment is completed electronically using the same re-enrollment
form as TVFC.
See the CHAPTER 1: TVFC PROVIDER ELIGIBILITY AND ENROLLMENT > II:
Provider Enrollment Requirements > I. Annual Re-enrollment section of this
manual for more information on annual re-enrollment.
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VII. Vaccine Ordering
A. Vaccine Choice
The ASN program supplies ACIP-recommended vaccines and toxoids.
Sites participating in the ASN program are required to offer all available
ACIP-recommended vaccines to their eligible populations. House Bill 448
from the 81st Texas Legislature gives ASN-enrolled sites the opportunity to
choose their preferred brands and presentations of vaccines from the
available formularies.
The signing clinician can choose vaccine brands and presentations. For new
ASN-enrolled sites, the RE will work with the site to choose vaccine brands
and presentations in VAOS.
ASN sites will be able to choose the brand and
presentation for each ASN program vaccine.
Changes or adjustments for specific vaccine
brands, presentations and percentages within
each vaccine “family” (i.e., Tdap), can be made,
or staff may take no action to maintain the
current selections. Clinic staff are encouraged
to review all choice selections as needed.
Vaccine coordinators may complete the
process; however, the signing clinician must be
consulted and agree to the vaccine choices. Only vaccines supplied by DSHS
to the ASN program will be available for vaccine choice.
If a chosen vaccine is not available, the ASN program has the authority to
replace the unavailable vaccine with a comparable substitution until the
chosen vaccine becomes available.
NOTE: Vaccine choice does not apply in the event of a disaster or public
health emergency, terrorist attack, hostile military or paramilitary actions, or
any other extraordinary law enforcement emergency.
NOTE:
The vaccine
inventory plan
requires all enrolled
sites to maintain a
75-day supply of
vaccine inventory.
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B. Vaccine Inventory Plan and Maximum Stock Levels
The vaccine inventory plan requires all enrolled sites to maintain a 75-day
supply of vaccine inventory. All sites should place vaccine orders monthly. All
components of vaccine inventory management and MSLs are the same for
TVFC and ASN. For more information, please see the CHAPTER 3: VACCINE
MANAGEMENT > II: Vaccine Ordering > B. Vaccine Inventory Plan and
Maximum Stock Levels section of this manual.
C. Increasing and Decreasing Maximum Stock Levels
The policies governing increasing and decreasing maximum stock levels are
the same for TVFC and ASN. For more information, please see the CHAPTER
3: VACCINE MANAGEMENT > II: Vaccine Ordering > C. Increasing and
Decreasing Maximum Stock Levels section of this manual.
D. Short-Dated Vaccine
The policies governing short-dated vaccines are the same for TVFC and
ASN. For more information, please see the CHAPTER 3: VACCINE
MANAGEMENT > II: Vaccine Ordering > D. Short-Dated Vaccine section of
this manual.
E. Storage Capacity for Vaccine Orders
An ASN-enrolled site must have adequate refrigeration and/or freezer space
to accommodate a maximum order based on MSLs. Sites must also take into
consideration the space needed for private stock vaccine when calculating
storage capacity.
F. Vaccine Ordering in the Vaccine Allocation and Ordering
System (VAOS)
The ASN program uses VAOS for vaccine ordering, which allows for
management of vaccine inventory online. All vaccine orders must be placed
in VAOS unless internet access is unavailable. Clinic staff may be held
responsible for vaccine loss that is a result of erroneous information entered
into VAOS.
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The policies governing vaccine ordering in VAOS are the same for TVFC and
ASN programs. For more information, please see the CHAPTER 3: VACCINE
MANAGEMENT > II: Vaccine Ordering > F. Vaccine Ordering in the Vaccine
Allocation and Ordering System (VAOS) section of this manual.
G. Vaccine Ordering for ASN Sites without Internet Access
An ASN-enrolled site without access to the internet must contact the RE for
assistance with vaccine ordering. Clinic staff must submit the following paper
forms to the RE to place a vaccine order:
• Monthly Biological Report, stock no. C-33
• Adult Biological Order Form, stock no. EC-68-2 and
• Temperature Recording Form, stock no. EC-105.
The monthly biological report is reviewed by the RE to ensure that the
beginning inventory matches the last month’s ending inventory. Calculations
must be correct. Any corrections needed are reported to clinic staff, so
records are corrected prior to ordering.
H. Vaccine Ordering for Newly Enrolled ASN Sites
Newly enrolled ASN sites are set up for vaccine ordering in VAOS after New
Provider Training with the RE. A vaccine order is placed as part of the
training. The RE collects and reviews the “Temperature Recording Form,”
stock no. EC-105, prior to placing the new vaccine order.
VIII. Vaccine Storage
All ASN sites are required to always follow the TVFC program storage and
handling guidelines. ASN-enrolled sites also enrolled in the TVFC program
must separate TVFC-provided pediatric doses from ASN-supplied adult
doses. The policies governing vaccine management are the same in TVFC
and ASN programs. Ensure CHAPTER 3: VACCINE MANAGEMENT section of
this manual is read and adhered to in its entirety.
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IX. Vaccine Management
It is critical that ASN-enrolled clinic staff familiarize themselves with
expectations for vaccine management.
The policies governing vaccine management are the same in TVFC and ASN
programs. Ensure CHAPTER 3: VACCINE MANAGEMENT section of this
manual is read and adhered to in its entirety.
X. Vaccine Transfers
The routine re-distribution of ASN vaccine is not allowed. However, vaccine
is allowed between ASN-enrolled sites when necessary to avoid vaccine loss
(i.e., if a provider’s storage unit is overstocked or if the provider withdraws,
is suspended, or terminated from the ASN program). If a transfer must
occur, clinic site staff are required to submit a “TVFC/ASN Vaccine Transfer
Authorization Form,” stock no. EC-67, in VAOS
and receive approval prior to conducting a
vaccine transfer. Note that electronic
“TVFC/ASN Vaccine Transfer Authorization
Forms,” stock no. EC-67, must be signed by
the primary coordinator, backup coordinator,
or signing clinician. The RE or clinic staff can
then initialize a vaccine transfer in VAOS if the
ASN program PIN of where the vaccines are
being transferred to is available.
Transfer information must be documented and tracked in VAOS. The policies
governing vaccine transfers are the same in TVFC and ASN.
Ensure CHAPTER 3: VACCINE MANAGEMENT > VI: Vaccine Transfers section
of this manual is read and adhered to in its entirety.
NOTE:
ASN sites must submit
a “Vaccine Transfer
Authorization Form”
and receive approval
prior to conducting
vaccine transfers.
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XI. ASN Billing and Administration
A. Billing for ASN Vaccine
Sites enrolled in the ASN program are prohibited from charging any
ASN-eligible adult for the cost of vaccines. ASN program vaccines are
provided at no cost to the enrolled sites to vaccinate eligible adults.
Charging for the cost of vaccines supplied by the ASN program constitutes
fraudulent behavior.
B. ASN Administration Fee
ASN sites may charge an administration fee for administering ASN vaccine to
ASN-eligible adults. The maximum administration fee that may be charged is
$25.00 per dose. ASN sites may not charge an
administration fee for the COVID-19 vaccine.
Services must not be denied due to the patient’s
inability to pay the administration fees. ASN sites
that choose to bill a vaccine administration fee
after the date of service must issue only a single
bill to the patient within 90 days of the
administration of the vaccine. ASN patients must
not be sent to collections or charge penalties for
the inability to pay administration fees.
XII. ASN Site Visits
A. Adult Immunization Standards
In 2013, the National Vaccine Advisory Committee (NVAC) revised the
“Standards for Adult Immunization Practice”. The new standards are aimed
at increasing adult immunization rates in the United States. The DSHS
Immunization program highly encourages all ASN-enrolled sites to adopt the
adult standards.
NOTE:
The maximum
administration fee
that an ASN-enrolled
site may charge is
$25.00 per dose.
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The “Standards for Adult Immunization Practice” are outlined below.
Assess
Assess immunization status for all patients at every clinical encounter.
To accomplish this, policies should be implemented to ensure that patients are
regularly screened for immunizations and reminded about vaccines needed.
Recommend
Strongly recommend all vaccines that patients need. Clinic site staff should
stay up to date on information pertaining to adult vaccines to best inform
patients.
Explain the reasons why a patient should receive the vaccine, as well as
address questions and concerns the patient may have. A strong
recommendation for a vaccine from a trusted health care professional can
make the difference for whether a patient chooses to receive the vaccine.
Administer or refer
Administer vaccines the patient chooses to receive. Vaccines that are
currently in stock should be offered. If there are vaccines that the patient
needs that are not in stock or available through the ASN program, patients
should be referred to sites in the area that offers the needed vaccine.
Document
All vaccines administered to adults must be documented and included in the
patient’s medical records. ASN-enrolled clinic sites must participate in
ImmTrac2, the Texas Immunization Registry.
The ASN program captures the aggregate number of doses administered
through monthly reports in VAOS. For more information regarding
documentation requirements, see Chapter 7: Documentation Requirements.
Visit http://www.cdc.gov/vaccines/hcp/adults/for-practice/
standards/index.html for more information regarding the “Standards for
Adult Immunization Practice”.
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In January 2017, DSHS incorporated the “Standards for Adult Immunization
Practices,” stock no. 6-252, into ASN site visits. DSHS Immunization
program has a contract with a QA contractor to conduct ASN site visits.
DSHS PHR staff may also conduct ASN site visits.
ASN site visits are driven by data to ensure sites with the most needs are
seen first. The purpose of the compliance visit is to assess, support and
educate the staff regarding ASN policies and procedures, not to critique. If
areas of concern are identified, the RE will provide a follow-up call or visit to
assist the clinic with changes or questions.
B. Adult Site Visits
ASN Compliance Visit Only
This visit focuses primarily on an ASN program policy review and a storage
and handling review. The storage and handling reviews are used to check for
proper vaccine storage and handling. Any issues identified will be addressed
immediately and staff are expected to make onsite corrections to safeguard
the vaccine.
C. Site Visit Scheduling and Clinic Access
Clinic sites will be contacted prior to a scheduled ASN site visit and will
receive a confirmation letter via email or fax that includes the date, time,
materials needed and summary of the site visit process.
During an ASN site visit, the reviewer will need access to the following:
• Space to work
• Power source (internet connectivity, if available)
• Access to patient records
• All temperature logs or data for the last three months or longer if
deficiencies are found
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• All “Vaccine Borrowing Forms,” stock no. EF11-14171, for the previous
12 months
• The circuit breaker
• Admitting and billing personnel to clarify eligibility screening and billing
processes
• Vaccine storage units where ASN vaccine is stored
D. Components of the ASN Site Visit
During the ASN site visit, the DSHS PHR reviewer and a clinic staff member
who is knowledgeable about the ASN program will work together to do
the following:
• Review the “Standards for Adult Immunization Practices”
Review required elements of patient immunization records (lot number,
manufacturer, title and signature of the person who administered the
vaccine, date of the VIS, date VIS was given to the patient for review,
date vaccine was given, clinic name and address)
• Review ASN program requirements (administration fee, temperature
recording, eligibility collection, etc.)
• Review vaccine management requirements for the ASN program
(temperature recording forms, water bottles, proper vaccine placement,
valid calibrated data logger, etc.)
The reviewer will provide a summary of areas of strength and areas for
improvement. Resources/recommendations for improving practices
will be provided.
E. Electronic Medical Record (EMR) Review
In recent years, the use of EMRs has become routine and has changed how
record reviews are conducted. If an EMR is in use at a site, clinic staff must
do one of the following:
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• Provide a dedicated staff member to log in to the EMR and sit with the
reviewer throughout the record review process to pull up EMR
immunization and eligibility records
• Provide printouts from the EMR of the immunization records and
documentation of the adult’s eligibility.
Site staff cannot login and turn access of the EMR over to the reviewer.
Clinic staff must be present if records have not been printed.
As a reminder, signing the “ASN Program Agreement” form is an
agreement to participate in ASN site visits, “Unannounced Storage and
Handling Visits,” and other educational opportunities associated with ASN
program requirements.
XIII. Mobile Vaccination Clinics
An ASN-enrolled clinic may conduct off-site, mobile vaccination clinics using
ASN program vaccines. However, ASN eligibility still must be collected by
using the “Adult Eligibility Screening Record,” stock no. F11-12842, or in an
EMR for all patients that receive ASN program vaccines at each visit.
Additionally, required vaccine storage and handling guidelines must always
be followed and the vaccine must be returned to the original approved
vaccine storage unit at the end of each day. Vaccines are extremely
sensitive to temperature excursions. Any exposure to out-of-range
temperatures could make the vaccine non-viable. For this reason, it is
important to regularly monitor the temperature of the vaccines and take
quick action when temperature excursions occur. Refer to Chapter 8: MASS
VACCINATORS, for specific information regarding the transporting of
vaccines for mass vaccination clinics and handling temperature excursions.
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XIV. Reporting Doses Administered
Qualified ASN-enrolled sites who also participate in the TVFC program are
required to distinguish between adult and pediatric vaccines and order and
report adult vaccines separately from TVFC pediatric vaccines. The “Tally and
Inventory with Physical Count Sheet” in VAOS is an optional form that may
assist in tracking adult and pediatric doses administered.
ASN-enrolled sites are required to enroll in ImmTrac2, Texas’ Immunization
Registry prior to receiving ASN vaccine. Adult vaccines are highly
encouraged to be reported into ImmTrac2. See CHAPTER 7:
DOCUMENTATION REQUIREMENTS > II. The Texas Immunization Registry
(ImmTrac2) for more information about ImmTrac2.
XV. Fraud and Abuse
As the complexity of immunizations and immunization-related programs
grows, ASN-enrolled clinic staff may become more vulnerable to
unintentionally committing acts that could be construed as fraud and/or
abuse. Fraud and abuse, whether intentional or not, is subject to all federal
fraud and abuse laws.
A. Definitions
A working understanding of what constitutes fraud and abuse is critical for
all persons working in the ASN program. Specific definitions of what
constitutes fraud and abuse can be found in the CHAPTER 6: FRAUD AND
ABUSE > II. Definitions section of this manual.
B. Examples
Fraud or abuse can occur in many ways. Some types of fraud and abuse are
easier to prevent or detect than others. All clinic staff should familiarize
themselves with the examples below, as they illustrate common practice
errors that could result in fraud or abuse allegations. This list provides
examples only and should not be considered an exhaustive list of
situations that would constitute fraud or abuse.
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• Provide ASN program vaccine to ineligible ASN patients
• Sell or otherwise misdirect ASN program vaccine
• Bill a patient or third party for ASN program vaccine (other than
administration fees)
• Charge more than $25.00 per dose for administration of an ASN
program vaccine
• Failure to meet licensure requirements for enrolled sites
• Deny ASN-eligible adults ASN program vaccine because of the inability to
pay an administration fee
• Send a patient to collections or charge additional fees for non-payment of
the administration fee
• Failure to implement program enrollment requirements of the
ASN program
• Failure to screen for and document ASN eligibility at every visit
• Failure to maintain ASN program records for five years
• Failure to fully account for ASN program vaccine
• Failure to properly store and handle ASN program vaccine
• Order ASN program vaccine in quantities or patterns that do not match
provider profile or otherwise involve over-ordering of ASN program doses
• Loss of ASN program vaccine due to negligent waste
C. Failure to Comply with ASN Program Requirements
A signature of a signing clinician on the TVFC/ASN program Agreement is an
agreement to comply with all ASN program requirements. Lack of adherence
to the ASN program requirements by an enrolled site could lead to fraud and
abuse of the ASN program. Non-compliance with ASN program requirements
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may occur due to an unintentional lack of understanding of the
requirements. Behavior may also be intentional. If non-compliance appears
intentional and a clinic has received financial benefits from the behavior, the
situation may result in immediate referral for investigation of suspected ASN
program fraud and abuse.
D. Fraud and Abuse Prevention
The ASN program actively works with enrolled clinic staff to help prevent
fraud and abuse in the ASN program. The best methods to prevent fraud and
abuse are strong educational components discussed during the initial site
enrollment process and during the ASN Compliance Visit. Both occasions
provide an opportunity to identify and prevent situations that may develop
into fraud and abuse.
E. Reporting Fraud and Abuse
Suspected fraud or abuse can be reported to the ASN program or the RE via
email, telephone, fax, or letter. Furthermore, newspaper articles and
internet pages that promote potential fraudulent situations are also
investigated. The RE and DSHS QAI contractors must report all alleged or
suspected fraud or abuse cases.
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CHAPTER 10: VACCINE INFORMATION STATEMENT (VIS)
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CHAPTER 10: VACCINE INFORMATION
STATEMENT (VIS)
All immunization clinic sites are required by the National Vaccine Childhood
Injury Act (NCVIA-42 U.S.C. 300ss-26) to provide a patient, parent,
guardian, or other responsible adult a current VIS. The appropriate VIS must
be given prior to vaccination and must be given prior to each dose of a
multi-dose series.
The VIS informs the client and their parent, guardian, or other responsible
adult about the benefits and risks of the vaccine the child/patient is
receiving. The most current version of each VIS must be provided. A list of
current VIS dates for each vaccine can be found on the Immunization Action
Coalition (IAC) website at www.immunize.org/vis.
A VIS may be provided as a paper copy or in the following ways:
• A permanent, laminated, office copy of each VIS, which must be read
prior to vaccination.
• A computer monitor or video display where the VIS can be reviewed.
• As a downloadable document that can be accessed via a smartphone or
other electronic device by the client, parent, guardian, or other
responsible adult to a smartphone or other electronic device.
The parent/patient must still be offered a copy in one of the formats
mentioned above to be read during the immunization visit, as a reminder.
A copy (which can be an electronic copy) of each appropriate VIS must be
offered to take away following the vaccination.
Reasonable steps must be taken to provide information in the appropriate
languages to ensure patients with limited English proficiency are effectively
informed. All VISs are available in more than 20 languages and can be
downloaded from the IAC website at www.immunize.org/vis.
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CHAPTER 11: ORDERING FORMS AND LITERATURE
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CHAPTER 11: ORDERING FORMS AND
LITERATURE
The DSHS Immunization program offers various forms, literature, brochures,
posters and VISs free of charge. Forms are available to view, download, or
ship directly to clinic sites. Allow 10 business days for delivery. Visit
www.immunizetexasorderform.com for a complete list of forms and
materials available for ordering.
If internet access is unavailable, clinic sites may send a request for literature
directly to the DSHS Immunization program via fax or mail.
When placing orders in writing, include the following elements:
• Stock number and/or title and requested quantity
• Physical address for delive
• Telephone number (including area code)
The request may be sent in one of the following ways:
Mail to: Immunization Section
Department of State Health Services
Mail Code-1946
P.O. Box 149347
Austin, Texas 78714-9347
Fax to: 512-776-7288, Attn: Public Information, Education and Training
(PIET) Department.
Call PiET at 800-252-9252 if you have questions regarding forms or the
ordering process.
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CHAPTER 12: IMMUNIZATION RESOURCES
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CHAPTER 12: IMMUNIZATION RESOURCES
• Adult Safety Net (ASN) Website
www.dshs.texas.gov/immunize/ASN/
• CDC Immunization Website
www.cdc.gov/vaccines/
• CDC Immunization Schedules
www.cdc.gov/vaccines/schedules/index.html
• CDC Vaccines for Children (VFC) Website
www.cdc.gov/vaccines/programs/vfc/index.html
• CDC Vaccine Storage and Handling Toolkit
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/
• CDC “You Call the Shots” Training
www.cdc.gov/vaccines/ed/youcalltheshots.html
• ImmTrac2, the Texas Immunization Registry
www.dshs.texas.gov/immunize/immtrac/default.shtm
• Immunization Action Coalition
www.immunize.org/
• Standards for Adult Immunization Practice
www.cdc.gov/vaccines/hcp/adults/for-practice/standards/
• Immunization Quality Improvement for Providers Program
dshs.texas.gov/immunize/Immunization-Quality-Improvement-for-
Providers-Program/
• Texas DSHS Immunization Website
www.immunizetexas.com/
CHAPTER 12: IMMUNIZATION RESOURCES
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• Texas Vaccine Education Online
https://learningportal.hhs.texas.gov/course/index.php
• Texas Vaccines for Children (TVFC) Website
www.dshs.texas.gov/immunize/tvfc/
VACCINE MANUFACTURERS CONTACT LIST
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Vaccine Manufacturers Contact List
Vaccine manufactures should be contacted in the event of a temperature
excursion to your vaccine storage unit. Refer to the vaccine manufacturer
information as listed on the box.
Vaccine Manufacturers Phone Numbers
GlaxoSmithKline 888-825-5249
Astra Zeneca 800-236-9933
Merck 800-672-6372
Sanofi Pasteur 800-822-2463
Seqirus USA, Inc 855-358-8966
Pfizer 800-438-1985
Grifols 888-474-3657
VACCINE MANUFACTURERS CONTACT LIST
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TVFC/ASN PROGRAM CONTACT INFORMATION
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TVFC/ASN Program Contact Information
DSHS Immunization Section: 800-252-9152
Responsible Entity Contact:
PINS Beginning with Responsible Entity Phone Number
00 City of San Antonio 210-207-3965
01 PHR 1 806-391-1323
02 PHR 2 325-795-5660
03 PHR 3 817-264-4790
04 or 05 not in Hardin,
Jefferson or Orange Counties
PHR 4/5N 903-533-5310
05 in Hardin, Jefferson or
Orange Counties, 06
PHR 6/5S 713-767-3410
07 PHR 7 254-778-6744
08 PHR 8 210-949-2067
09 PHR 9 432-571-4137
10 PHR 10 915-834-7924
11 PHR 11 956-421-5552
25 City of Houston 832-393-5188
TVFC/ASN PROGRAM CONTACT INFORMATION
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2024 MANUAL REVISION HISTORY
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2024 Manual Revision History
GENERAL MANUAL REVISIONS
• Updated Texas Vaccines for Children (TVFC) and Adult Safety Net (ASN)
verbiage to specify which policies applied to each program throughout
manual sections.
• Replaced DSHS Immunization Section with DSHS Immunization program.
• Updated TVFC Facility Types.
• Updated grammatical errors.
CHAPTER 1: TVFC SITE ELIGIBLITY AND ENROLLMENT
• TVFC site eligibility list has been updated.
• Added a requirement for primary vaccine coordinator/backup vaccine
coordinator to have unique email addresses.
• Clarified language for the required trainings the primary vaccine
coordinator/backup vaccine must complete.
CHAPTER 2: TVFC PATIENT ELIGIBILITY AND SCREENING
• Removed HPV and Varicella from ASN catch-up vaccines for patients who
are 19 years of age and who previously initiated a vaccination series
under the TVFC program.
CHAPTER 3: VACCINE MANAGEMENT
• Added Respiratory Syncytial Virus (RSV) to the TVFC approved vaccines.
• Clarified that only primary vaccine coordinator/backup vaccine will have
access to VAOS.
• Included language about providers using both compartments of a
household combination unit.
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o If the unit is consistently maintaining the required temperature
ranges, may continue to do so. If temperature excursions occur that
can't be attributed to another cause (e.g., power outage), the provider
must discontinue use of one of the compartments.
• Included language about providers enrolled after July 1, 2024.
o These providers will not be allowed to use the freezer compartment of
a household combination unit.
• Included language for auto-dispensing units.
o A service record is required for auto-dispensing units in lieu of a
certificate of calibration. Servicing must be completed on auto-
dispensing units as specified by the manufacturer. Monthly
temperature logs must be recorded and submitted each month on the
seventh. Ensure that temperature logs are posted on the unit, as with
other cold storage units.
• Updated how to read a data logger and what classifies as a temperature
excursion.
o Record the numbers on both slides of the decimal point and do not
round (Ex: For 46.1°F or 8.1°C, note that the numbers to the right of
the decimal meet the criteria for a temperature excursion). If a
temperature excursion occurs based on the updated guidance,
TVFC/ASN program providers must reach out to the vaccine
manufacturer to obtain guidance on vaccine viability.
• Added language for portable vaccine refrigerator/freezer units.
o If a portable vaccine refrigerator/freezer unit is used to transport
vaccines, follow the manufactures requirements regarding the use of
use packing material, i.e., bubble wrap or cardboard.
• Updated VAOS reporting date from between the first and fifth to between
the first and seventh.
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CHAPTER 5: PROGRAM EVALUATION
• Updated “Standards for Childhood Immunizations” to include all 18
standards
• Updated common site visit structures section to flow more cohesively
• Included language for site visits
o The signing clinician, primary vaccine coordinator, or backup vaccine
coordinator be present at all site visit related activity.
CHAPTER 7: DOCUMENTATION REQUIREMENTS
• Updated ImmTrac2 vaccine eligibility reporting codes.
CHAPTER 9: ADULT SAFETY NET PROGRAM
• Removed Human Papillomavirus (HPV), Pneumococcal Conjugate
(PCV20), Pneumococcal Polysaccharide (PPSV23) and Varicella from the
ASN formulary.
• Added Monovalent Coronavirus (COVID-19) to the ASN formulary.
• Added information on the COVID-19 vaccine.
o The COVID-19 vaccine will remain available to enrolled ASN providers
on a temporary basis and updates will be provided as they are
made available.
• Added language about COVID-19 vaccine administration fees.
o ASN sites may not charge an administration fee for the
COVID-19 vaccine.
ASN PROGRAM
2024 MANUAL REVISION HISTORY
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Texas Department of State Health Services Stock No. 11-13602
Immunization Section Rev. 09/2023
Texas Department of State Health Services
Immunization Section
MC-1946
P.O. Box 149347
Austin, TX 78714-9347
800-252-9152
ImmunizeTexas.com
