Download Minnesota Vaccines for Children Separate Stock Clinics: Policies and Procedures Manual 2015

Minnesota Vaccines for Children
Separate Stock Clinics:
Policies and Procedures Manual
2015
Minnesota Department of Health
Immunization Program
625 N Robert Street
St. Paul, MN 55164-0975
www.health.state.mn.us/vfc
651-201-5522 or 1-800-657-3970
Fax: 651-201-5501
Table of Contents
Page
Signature Page ..................................................................................1
MnVFC Basics....................................................................................3
MnVFC Requirements vs. Best Practices........................................4
How to Administrate the MnVFC Program
1.
2.
3.
4.
5.
6.
7.
Screen patients for MnVFC eligibility........................................................... 6
Charge only allowable fees......................................................................... 8
Give patients a VIS with each immunization............................................. 10
Comply with recommended immunization schedules................................ 11
Report adverse reactions to VAERS.......................................................... 12
Document immunizations in medical charts.............................................. 13
Keep MnVFC program records for three years......................................... 14
How to Manage the MnVFC Program
8.
9.
10.
11.
12.
13.
Have the right refrigerator/freezer(s) and thermometer(s)......................... 16
Receive and store vaccine carefully.......................................................... 21
Keep privately purchased vaccine separate from MnVFC vaccine........... 25
Manage MnVFC vaccine inventory efficiently............................................ 26
Post an emergency plan for managing vaccine......................................... 29
Post an anaphylaxis protocol..................................................................... 30
How to be Accountable in the MnVFC Program
14.
15.
16.
17.
18.
19.
Assign an immunization manager and a vaccine coordinator................... 32
Follow up on feedback you receive from site visits................................... 34
Renew your enrollment in MnVFC each year............................................ 36
Submit an annual report............................................................................ 37
Avoid fraud and abuse............................................................................... 38
Replace MnVFC vaccine wasted due to negligence................................. 39
Contacts and Resources................................................................. 42
Appendices....................................................................................... 43
A. Clinic Billing Office Tips for MnVFC, Minnesota Department of Health
B. MnVFC Vaccine Management Checklist, Minnesota Department of Health C. Worksheet for Developing an Emergency Plan for Managing Vaccine,
Minnesota Department of Health
D. Emergency Response Worksheet, Immunization Action Coalition
E. Medical Management of Vaccine Reactions in Children and Teens, Immunization Action Coalition
F. Medical Management of Vaccine Reactions in Adult Patients, Immunization Action Coalition
G. MDH Vaccine Restitution Appeal Form, Minnesota Department of Health
H. VFC Vaccine Borrowing Report, Centers for Disease Control and Prevention
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
Page 1
Signature Page
As a MnVFC provider, it is a federal requirement that you have written immunization
policies (on immunization staff assignments, emergencies, ordering and receiving
vaccine, monitoring vaccine inventory, storing and handling vaccine, vaccine wastage,
and staff training on vaccine management including storage and handling).
You can use this manual to fulfill most of this requirement if:
• You attach your own emergency plan and anaphylaxis protocols to the manual. (See
appendices C, E, and F of this manual for examples and resources.)
• Your immunization manager and vaccine coordinator and their backups read this manual
and sign this page, certifying that they have read the manual. You need to notify the
MnVFC Program if the person fulfilling these roles changes. See page 32 for more
information about this requirement.
In addition, consider having all staff whose work relates to immunizations read this manual and
sign and date this page (for example, the desk clerk who receives immunization shipments and
billing personnel).
By signing below I certify that I have read the 2015 MnVFC manual.
Name
Immunization Manager*:
Date
Backup Manager:
Vaccine Coordinator*:
Backup Coordinator:
*Duties of the immunization manager, vaccine coordinator, and backups can be found on pages 32-33.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
Page 2 MnVFC Separate Stock Manual, 2015
Name
MnVFC Program: 651-201-5522
Date
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
Page 3
MnVFC Basics
What is MnVFC?
The Minnesota Vaccines for Children (MnVFC) program is Minnesota’s version of the federal
Vaccines for Children (VFC) program which works to make vaccine accessible and affordable
for all children from birth through 18 years of age. The program distributes about $39
million worth of vaccines to public and private clinics in Minnesota each year. It is run by the
Immunization Program at the Minnesota Department of Health (MDH).
Why enroll in MnVFC?
First and foremost, MnVFC saves your clinic money by providing vaccine at no cost for eligible
children. MnVFC also increases patient satisfaction by providing your patients access to
vaccine without having to leave their medical home. And MnVFC participation helps increase
your immunization rates, because you are able to provide vaccine to eligible patients who
otherwise could not afford them.
In addition, by Minnesota law, your clinic must enroll in MnVFC if you administer vaccines to
children who are in a Minnesota Health Care Program (MHCP), including:
• Medical Assistance (MA)
• MinnesotaCare
• Prepaid Medical Assistance Programs (PMAP)
How do you enroll in MnVFC?
1. Call or email the MnVFC program (651-201-5522, [email protected]) to start the
enrollment process.
2. A packet of information and forms will be sent to you. Carefully review and complete all
documents and return to the address provided.
3. The MnVFC program will review the forms for completeness. MnVFC staff will contact you
to get any missing information.
4. Your site will be placed on a waiting list for an enrollment visit by MnVFC staff. You must
have a visit before you are allowed to order.
5. Once you have met the requirements of the MnVFC program and you have been assigned
a PIN number, you will be eligible to order MnVFC vaccine.
6. Place your first order for MnVFC vaccine within 90 days from your initial site visit. If you
wait longer you will have to have another enrollment site visit.
Helpful definitions
In this manual, all sites that administer vaccine to MnVFC-eligible children will be referred to as
clinics.
Separate stock involves keeping privately-purchased vaccine separate from publicly
purchased vaccine. Patients must receive vaccine from the correct vaccine “stock” based on
their eligibility.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
Page 4 MnVFC Separate Stock Manual, 2015
Replacement method allows a site to use privately-purchased vaccine to vaccinate MnVFCeligible children and the MnVFC program replaces the private vaccine that was administered.
Only sites with grandfathered status are allowed to use the replacement method.
If you received this version of the 2015 manual, you have been identified by MDH as a
separate stock clinic. If you believe this is an error, please contact the MnVFC program at 651201-5522 or 1-800-657-3970.
This version of the manual can also be found online at www.health.state.mn.us/vfc.
MnVFC Requirements vs. Best Practices
Federal law established the VFC program and set the policies that govern it, as described in
this manual. The manual simplifies MnVFC requirements in a way we hope will be clear and
workable for you. For that reason, it does not try to cover the full range of immunization best
practices and recommendations, though we refer you to many other resources that do.
It is the intent of the MnVFC program to promote excellence in immunization practice across
the state while ensuring that program requirements are met. While the program requires
specific vaccine management, the same principles can be applied to your broader vaccine
supply. Loss or waste of vaccines is costly - no matter who has purchased them.
The Annual Provider Agreement is a legal contract. When you sign the Annual Provider
Agreement you are agreeing to comply with all the requirements listed on the form.
Refer to the following references for immunization best practices and the Centers for Disease
Control and Prevention (CDC) recommendations for storage and handling of vaccines:
• Got Your Shots? A Provider’s Guide to Immunizations in Minnesota at www.health.state.
mn.us/divs/idepc/immunize/hcp/provguide/index.html
• Vaccine Recommendations of the Advisory Committee for Immunization Practices (ACIP)
at www.cdc.gov/vaccines/hcp/acip-recs/index.html
• Vaccine Storage and Handling Recommendations and Guidelines at www.cdc.gov/
vaccines/recs/storage/default.htm
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
How to Administrate the
MnVFC Program
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
Page 6
How to Administrate the MnVFC Program
1. Screen patients for MnVFC eligibility.
• Screen each patient who is 18 years and younger before administering vaccines to
determine if they are eligible for MnVFC vaccine.
• Document the screening information in a paper or electronic file at each immunization
visit.
• Keep the eligibility screening record for three years from the date of the last visit.
Screening patients for eligibility
• Prior to immunizing each patient who is 18 years and younger, you must inform the
patient, parent, or legal representative of the MnVFC eligibility criteria and/or give
them a form to complete. (The MnVFC program has a self-screening form for children
that you can have the parent fill out, called Can my child get free or low-cost shots?.)
• If the patient has insurance, advise the patient/parent there are places to receive no
or low cost vaccinations if they are not sure if vaccinations are covered.
• If the patient wants to call their insurance company to check on their coverage,
please provide access to a phone.
• You are not required to verify the patient’s response to the screening questions. For
example, if patients say they have lost their insurance you do not need to call their
insurance company to confirm.
Documenting eligibility screening
• Document eligibility screening in the patient’s medical record (chart) or in a separate
file. Documentation means a notation must be made on a record even if the patient
is not eligible for MnVFC. (The MnVFC program provides screening record forms for
children and adults on its website. You don’t have to use the MnVFC forms, but you
do have to collect all the information that is on them.)
• You can keep the same form and have the patient, parent, or guardian review it each
time the patient receives a vaccination.
• Document that eligibility screening was completed at each visit.
• If a patient is eligible for more than one category, the provider must select the
category that will require the least amount of out-of-pocket expense to the patient.
• Your clinic can submit MnVFC eligibility status to the Minnesota Immunization
Information Connection (MIIC). The MnVFC program also refers to this information
as dose-level eligibility. Dose-level eligibility is an early step toward increasing
accountability for our vaccine programs and meeting federal requirements. While
reporting eligibility to MIIC is currently optional, clinics are encouraged to begin
submitting this information. For more technical information see Reporting Dose-Level
Eligibility to MIIC at www.health.state.mn.us/divs/idepc/immunize/registry/hp/data.
html.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Administrate the MnVFC Program
MnVFC eligibility criteria
Here is an overview of MnVFC eligibility criteria. For up-to-date details, see the
MnVFC Patient Eligibility Screening Record forms on the website at
www.health.state.mn.us/vfc.
Children 18 years and younger
The following three categories can receive MnVFC vaccine at any MnVFC enrolled
clinic:
• Uninsured,
• Enrolled in a Minnesota Health Care Program: Medical Assistance (MA),
MinnesotaCare, or a Prepaid Medical Assistance Program (PMAP), or
• American Indian or Alaskan Native.
The following two categories are considered underinsured and are only MnVFC eligible
at local public health (LPH), Federally Qualified Health Centers (FQHC), Rural Health
Centers (RHC), Indian Health Services (IHS), and tribal health clinics:
• Has health insurance that does not cover one or more vaccines, as can be the case
with newly licensed vaccines that aren’t yet covered (MnVFC-eligible for
non-covered vaccines only).
• Has health insurance that caps vaccine coverage at a certain amount; once that
amount is reached, the person is MnVFC-eligible.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Administrate the MnVFC Program
2. Charge only allowable fees.
• Charge only the allowable fees, set by federal law, for administering MnVFC vaccine.
• Waive the administration fee for MnVFC vaccine if a patient is unable to pay.
• Do not charge a patient for the cost of vaccine if they are eligible for MnVFC vaccine.
Charging allowable administration fees
• You may charge MnVFC-eligible patients an administration fee of up to $21.22 per
dose (not per antigen) for administering MnVFC vaccine. This fee limit is set by
federal law.
• You may also charge for the office visit, but not for the MnVFC vaccine.
• To be reimbursed for the administration fee for pediatric patients enrolled
in a Minnesota Health Care Program (MHCP), you must follow the billing
procedures of each program. MHCP programs include Medical Assistance
(MA), MinnesotaCare, or a Prepaid Medical Assistance Program (PMAP). These
programs will reimburse you the contract rate, refer to the Minnesota Department
of Human Services MHCP Managed Care Organization Contacts website,
www.dhs.state.mn.us/dhs16_147769 for more information.
Permissible MnVFC vaccine administration fees
Patient’s status
MnVFC eligible?
Medicaid eligible1
Yes
Uninsured2
Yes
American Indian/Alaska native
Yes
Underinsured3
Privately insured
Permissible
administration fee
$21.22/dose
Only at LPH, FQHC, RHC, IHS,
and tribal health clinics
No
Usual and customary
1
Minnesota Health Care Program (MHCP) enrollee: MN Medical Assistance (MA), MinnesotaCare, or a
Prepaid Medical Assistance Program (PMAP)
2
Does not have any insurance
3
Patients with private insurance that does not cover the vaccine itself. These children are only MnVFC
eligible at local public health (LPH), Federally Qualified Health Centers (FQHC), Rural Health Centers
(RHC), Indian Health Services (IHS), and tribal health clinics.
Preventive services like immunizations are often covered even if a deductible remains. If the vaccine is
covered the child will not be considered to be “underinsured” for MnVFC purposes.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Administrate the MnVFC Program
Removing vaccine charges from a MnVFC-eligible patient’s bill
• Make sure your billing department is prepared to respond to questions related to
MnVFC eligibility and to adjust bills as needed; see Appendix A: Clinic Billing Office
Tips for MnVFC.
Waiving the administration fee
• You may bill patients an administration fee, but if they are unable to pay this fee it
must be removed from their bill. Having these bills go to collections is not acceptable.
• No MnVFC-eligible patient may be denied vaccine for failure to pay an administration
fee.
Consequences of not meeting this requirement
• Not charging administrative fees according to MnVFC policy could be considered
fraud and abuse. (See section 18.)
• Examples of fraud and abuse include:
○○ Billing a patient or third party for MnVFC vaccine.
○○ Charging more than the maximum allowable charge for administration of a
MnVFC vaccine ($21.22).
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Administrate the MnVFC Program
3. Give patients a VIS with each immunization.
• Provide a current Vaccine Information Statement (VIS) every time a patient receives
a vaccine.
• Document the publication date of the VIS and the date the VIS was given in the
patient’s medical record.
• You must give a VIS (either paper or electronic) to the patient or their parent or legal
representative before administering each dose of vaccine.
• You must document the publication date of the VIS, located on the bottom corner of
each VIS, in the patient’s medical record and the date the patient was given the VIS
to review.
• Let the patient, parent, or legal representative keep a paper copy of the VIS,
or if they prefer to download the VIS onto a mobile device, direct them to the
Center for Disease Control and Prevention’s (CDC) patient download website
(www.cdc.gov/vaccines/hcp/vis/mobile.html) during the visit and make sure they have
a chance to have their questions answered. Give them a phone number to call in
case of any questions or unexpected symptoms after receiving a vaccine.
• When possible, provide the VIS in the person’s native or preferred language.
Translated VISs are available from the Immunization Action Coalition at
www.immunize.org/vis/.
• You do not need to have the patient, parent, or legal representative sign anything to
show they have received the VIS, unless your practice requires this.
• It is acceptable to make a VIS available to be read before the immunization visit (e.g.,
by giving the patient or parent a copy to take home during a prior visit, or telling them
how to download or view it on the Web). We encourage this when possible. These
patients must still be offered a copy (it may be a laminated copy) to read during the
immunization visit and a paper copy to take home.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Administrate the MnVFC Program
4. Comply with recommended immunization schedules.
Comply with immunization schedules, dosage, and contraindications that are
established by the Advisory Committee on Immunization Practices (ACIP) and included
in the MnVFC program unless:
a) In the provider’s medical judgment, and in accordance with accepted medical
practice, the provider deems such compliance to be medically inappropriate, or
b) The particular requirements contradict state law, including laws pertaining to
religious and other exemptions.
• The current ACIP recommended schedules can be located at:
www.health.state.mn.us/divs/idepc/immunize/hcp/schedules.html
• Use the Guide to Contraindications and Precautions located at:
www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/screen.html#screen
• The state laws related to vaccination requirements and acceptable vaccine
exemptions can be located at:
www.health.state.mn.us/divs/idepc/immunize/laws/index.html
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Administrate the MnVFC Program
5. Report adverse reactions to VAERS.
Submit a report to the Vaccine Adverse Events Reporting System (VAERS) if a patient
has an adverse reaction after receiving a vaccine.
• Federal law requires that all health care providers must report adverse events that
occur following vaccination to VAERS. (Consumers may also submit a VAERS
report.)
• Adverse events are defined as health effects that occur after immunization that may
or may not be related to the vaccine.
• Submit the form as soon as possible after an adverse event following vaccination.
The back of the form has a pre-printed address and prepaid postage for mailing. You
may also submit information by phone, by fax, or through the VAERS website.
• For more information or a copy of the form and help completing it, call VAERS at
800-822-7967 or visit http://vaers.hhs.gov.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Administrate the MnVFC Program
6. Document immunizations in medical charts.
Maintain immunization records in accordance with the National Childhood Vaccine
Injury Act, which states that you must document certain required information in each
patient’s medical record for each dose of vaccine given.
• Must include this federally required information:
○○ Clinic/facility address where the vaccine was administered.
○○ Date vaccine was administered.
○○ Vaccine type.
○○ Vaccine manufacturer.
○○ Vaccine lot number.
○○ Signature and title of person(s) administering vaccine.
○○ Publication date of VIS (located at the bottom of VIS).
○○ Date VIS was given to the patient, parent, or legal representative (usually the
same as the vaccine administration date, but still needs to be documented).
• Best practice recommendations include documenting the following information:
○○ Dose.
○○ Site and route of injection.
○○ History of vaccine reaction, if the patient has experienced a clinically significant or
unexpected event after an immunization (even if there is uncertainty that the
vaccine caused the event).
○○ Contraindications and precautions that may apply to this patient.
○○ Serologic test results related to vaccine-preventable diseases.
• For combination vaccines, record the vaccine information in the spaces that
correspond to each individual antigen in the combination product, indicating the
combination type (for example, DTaP-IPV-Hep B) and the name of the combination
vaccine (for example, Pediarix).
• You can order patient immunization record forms from the MnVFC program.
• You should give patients/parents a record of each immunization. Fill out an
immunization record card (available from MDH) or, if your clinic is enrolled in
the Minnesota Immunization Information Connection (MIIC), print out the MIIC
immunization record.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Administrate the MnVFC Program
7. Keep MnVFC program records for three years.
Keep all records related to the MnVFC program for at least three years.
• You must keep the following MnVFC records for at least three years:
○○ MnVFC eligibility screening information (forms or documentation in the electronic
medical record).
○○ Temperature logs.
○○ Certificate of calibration for each thermometer used.
○○ Vaccine Storage Unit Troubleshooting Log or other documentation about storage
and handling incidents.
○○ MDH Vaccine Transfer Record forms.
○○ Nonviable MDH Vaccine forms, if you have used them.
○○ Packing lists of vaccine shipments or logs with lot numbers.
○○ Monthly inventory log.
○○ VFC Vaccine Borrowing Report or other borrowing documentation.
○○ Annual Report of the Number of Patients Immunized with Vaccine from MDH.
○○ Minnesota Vaccines for Children (MnVFC) Program Annual Provider Agreement.
○○ Certificate of completion of the annual MnVFC online training.
• Check with your own clinic’s policies about keeping records beyond three years.
• Note: MnVFC forms are available on the website at www.health.state.mn.us/vfc.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
How to Manage the
MnVFC Program
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Manage the MnVFC Program
8. Have the right refrigerator/freezer(s) and thermometer(s).
• Have and maintain appropriate vaccine refrigerator/freezer(s) to store vaccine.
• Use a thermometer that has a current Certificate of Calibration to monitor
temperatures in each refrigerator/freezer used to store MnVFC vaccine.
• Place the temperature sensor probe in the center of the refrigerator/freezer with the
vaccine.
• Have one back-up thermometer with a current and valid Certificate of Calibration at
each MnVFC site.
Refrigerator/freezers:
• Must be appropriate for storing vaccine.
• The use of combination refrigerator/freezers with one exterior door is not allowed for
storing MnVFC vaccines.
• Storage units, in order of preference are;
1. Commercial lab or pharmacy grade unit, including: refrigerator-only, freezer-only
or a combination refrigerator/freezer unit with separate exterior doors and
separate controls. Solid doors are preferred to glass doors because they maintain
appropriate temperatures longer if a unit loses power.
2. Household stand-alone refrigerator and/or stand-alone freezer.
3. Household combination refrigerator/freezer built within the last 10 years, with
separate doors and separate temperature controls. It is recommended that only
the refrigerator portion of the unit be used for vaccine storage and a separate
stand-alone freezer be used to store frozen vaccine. Frost-free or automatic
defrost cycle units are preferred.
Note: “Medical grade” unit may only indicate that it can be plugged in near oxygen
and has a lock on the door; not that it is necessarily appropriate for vaccine storage.
Other criteria should be used to decide if the unit is appropriate for vaccine storage.
Call the MnVFC program for guidance.
If you will be purchasing a new storage unit, it is highly recommended that you
purchase pharmaceutical grade units or stand-alone household units.
• Must be able to maintain required vaccine storage temperatures:
○○ Refrigerator 35°F through 46°F (2°C through 8°C), aim for 40°F (5°C).
○○ Freezer -58°F through +5°F (-50°C through -15°C), aim for 0°F (-18°C).
• Be large enough to hold the year’s largest inventory, for example, the back-to-school
rush or the flu season, based on how many doses of vaccines you order annually
(see Volume Based Refrigerator and Freezer Recommendations on page 17).
• Must be used only for vaccines or other medical supplies.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Manage the MnVFC Program
Volume Based Refrigerator and Freezer Recommendations
Volume
High
Approximate
Recommended refrigerators/freezers
doses/year
10,000 or
more
Medium
2,000-10,000
Low
2,000 or less
• Large capacity purpose-built (lab or pharmacy grade)
refrigerator-only or freezer-only unit designed for
optimum cooling capacity and stable temperature
control.
In order of preference, with the first being the best:
yy Purpose-built (lab or pharmacy grade) refrigerator-only
or freezer-only unit designed for optimum cooling capacity
and stable temperature control.
yy Household refrigerator-only or freezer-only unit (can be
an under-counter model).
In order of preference, with the first being the best:
yy Smaller, under-counter version of a purpose-built
(lab or pharmacy grade) refrigerator-only or
freezer-only unit.
yy Household refrigerator-only or freezer-only unit.
○○ Storage of staff food and beverage is not allowed in vaccine storage units.
○○ Sharing a lab refrigerator is not recommended because of possible contamination
of the vaccine and an increase in temperature fluctuations due to increased
frequency of the door opening and closing. If you must store vaccines in a
refrigerator that contains lab specimens, store the specimens on a separate shelf
below the vaccines.
○○ Vaccines may be stored in a shared pharmacy refrigerator/freezer, if there is room
for air to circulate and if the proper temperature range can be maintained.
• Must be plugged directly into an electrical outlet. Do not plug into a ground fault
interrupter (GFI) outlet, use extension cords or power strips.
• Must be repaired or replaced immediately if there are mechanical problems.
• You may need to submit at least one week of temperature logs on a repaired or
new vaccine storage unit, indicating that the temperature in it has stabilized in the
appropriate range, before additional vaccines are sent to you.
Thermometers:
• You may use thermometer(s) provided at no cost by the MnVFC program or an
alternate version. The MnVFC program will provide up to four thermometers per
site. You can request thermometers by emailing your site name, address, contact
person, and MnVFC PIN number to [email protected]. It can take up to five
business days for you to receive the thermometers.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Manage the MnVFC Program
• The National Institute of Standards and Technology (NIST) defines a thermometer as
a unit consisting of a probe and a readout device used together. When recalibrating
a thermometer, or any temperature monitoring system, the probe and the readout
device must be calibrated together to be considered valid.
• Thermometer recommendations
○○ Continuous monitoring device or digital data logger with the following
specifications:
-- Digital display on outside of storage unit.
-- Detachable probe in a bottle filled with a thermal buffer, placed in the center of
the storage unit.
-- Alarm to alert out-of-range temperatures.
-- Accuracy within +/- 1°F (0.5°C).
-- Low battery indicator.
-- Continuous monitoring capabilities to track and record temperatures over time.
-- Display of current, as well as minimum and maximum temperatures.
○○ Thermometers that are NOT recommended include:
-- Fluid-filled biosafe liquid temperature monitoring devices.
-- Bi-metal stem temperature monitoring devices.
-- Food temperature monitoring devices.
-- Household mercury temperature monitoring devices.
-- Chart recorders.
-- Infrared temperature monitoring devices.
-- Temperature monitoring devices that are not calibrated.
• You must have a valid and current Certificate of Calibration (also known as Report of
Calibration) for each thermometer.
• Calibration of thermometers must be performed at a minimum of every two years
from the last calibration testing date (date certificate issued). All thermometers
will "drift" over time and normal use can impact their accuracy, as a result all
thermometers require recalibration.
• The Certificate of Calibration must be kept with your other MnVFC documents for
three years. You will need to show this certificate at your MnVFC site visit.
• There are three options for obtaining a Certificate of Calibration:
○○ Option 1 (preferred method)
Purchase a thermometer or data logger that already has a Certificate of
Calibration from an ILAC MRA accredited laboratory or manufacturer. Laboratory
accreditation should be clearly identifiable on the Certificate of Calibration (also
know as Report of Calibration) with the Accrediting Body Symbol:
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Manage the MnVFC Program
The Certificate of Calibration must include the following elements:
-- Model and serial number that matches the device reviewed.
-- Date of calibration or a calibration report date.
-- Whether the instrument passed or failed the testing.
-- Documented uncertainty of +/- 1°F (0.5°C).
○○ Option 2
Purchase a thermometer or data logger that has a Certificate of Calibration from a
non-ILAC MRA accredited laboratory that includes the following elements:
-- Model and serial number that matches device reviewed.
-- Date of calibration testing or a calibration report date.
-- Whether instrument passed or failed testing.
-- Documented uncertainty of +/- 1°F (0.5°C).
-- Information that demonstrates that the laboratory performing the testing
maintains a measurement assurance program and meets current ISO/IEC
17025 standards for calibration testing and traceability.
○○ Option 3
Calibration may be conducted by trained clinic staff or a bio-medical company if
the tool being used for calibration has a Certificate of Calibration from an ILAC
MRA signatory body or a laboratory or manufacturer that is not accredited by ILAC
MRC with a certificate that includes the following required elements:
-- Model and serial number that matches device reviewed.
-- Date of calibration testing or calibration report date.
-- Whether instrument passed or failed testing.
-- Documented uncertainty of +/- 1°F (0.5°C).
-- Information that demonstrates that the laboratory performing the testing
maintains a measurement assurance program and meets current ISO/IEC
17025 standards for calibration testing and traceability.
Documentation with the above information is required for each thermometer that
is recalibrated in addition to the calibration certificates for the testing tool.
• Must have the temperature sensor probe placed in the center of the refrigerator/
freezer with the vaccine.
○○ If your unit has a built in thermometer, the temperature sensor probe must be
placed in the center of the storage unit. If you are not able to place the sensor
probe in the center of the unit, you will need to use a different thermometer with
the probe placed in the center of the storage unit.
○○ Should have a biosafe glycol-encased temperature sensor probe that will
measure liquid temperature.
○○ CDC recommends the use of continuous digital data loggers with detachable
probes encased in biosafe glycol for temperature monitoring.
• If you are using a continuous electronic monitoring system (examples: TempTrak,
Isensix, Sensaphone) you should have written procedures identifying:
○○ Who is responsible for maintaining the system.
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○○ When and how the system is recalibrated.
○○ Who responds to out-of-range temperatures and at least one backup.
○○ Who is responsible for documenting the response and the location of the
documentation.
○○ A schedule for regularly reviewing temperature logs (e.g., daily, weekly, monthly).
• Must have one backup thermometer that is not in use, with a valid Certificate of
Calibration at each MnVFC site.
○○ It must be available in case a thermometer in use is not working properly or
current equipment requires calibration testing.
○○ The Certificate of Calibration must have a different calibration date than the other
thermometers at the site.
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9. Receive and store vaccine carefully.
• Have a written vaccine management plan with routine and emergency vaccine
storage and handling procedures for storing and receiving vaccines. See Appendix
B: MnVFC Vaccine Management Checklist for what must be included in a vaccine
management plan.
• The vaccine management plan must include the annual date of review and the
reviewer's name, title, and signature.
• Properly handle vaccine shipments. If the vaccine shipment is compromised in any
way, the provider should contact McKesson Specialty Customer Care (MSCC) at
1-877-TEMP123 (1-877-836-7123) immediately.
• Varicella and MMRV must be shipped directly from Merck to the clinic site.
Redistribution is not allowed.
• Each day the clinic is open, manually check and record temperatures twice a day in
all refrigerators and freezers used to store MnVFC vaccine at that clinic site.
• The person checking the temperatures must document the date, time, and their
initials at each temperature check.
• Take immediate action on out-of-range temperatures.
• Post “Warning” stickers on the circuit breakers and "Do Not Unplug" stickers on the
vaccine storage unit electrical outlets.
Receiving vaccine shipments
• Must check the condition of all vaccines immediately when they arrive.
○○
○○
○○
○○
Open vaccine packages immediately.
Cold or warm mark indicators must not be activated.
Inspect the vaccine and packaging for damage.
Determine the length of time the vaccine was in transit by looking at the packing
list.
• Refrigerated vaccines
○○ Should be cold but not frozen. (Note: MMR will arrive refrigerated from McKesson
and the MnVFC program recommends storing it in the freezer.)
○○ If the vaccine shipment is compromised in any way, the provider must contact
MSCC immediately at 1-877-TEMP123 (1-877-836-7123). This number is also
printed on the temperature indicators.
○○ It is critical that MSCC be contacted within the same day the vaccine arrived at
the provider's office.
• Frozen vaccines
○○ Merck has replaced the use of dry ice with frozen gel packs in the shipping
packages for Varivax (VAR) and ProQuad (MMRV). A predetermined number of
gel packs, based on Merck validation testing, are placed in the shipping container
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to maintain proper temperatures for four days from the shipping date on the
packing list.
○○ If more than four days have passed since the vaccine was shipped or you have
any concerns about the condition of the vaccine, call Merck immediately at
1-800-673-6372.
• Compare the vaccine products received with the products that appear on the packing
list. Report any discrepancies to the MnVFC program at 651-201-5522.
• Immediately store at the appropriate temperature.
• Make a note on the packing slip or a log of the date and time received, packing
material condition, and temperature indicator status.
• Keep packing slips and/or inventory logs for at least three years.
• Put vaccines with the earliest expiration date in front to be used first to prevent
vaccines from expiring.
• If you receive vaccine with an expiration date of six months or less, call the MnVFC
program for guidance.
• Redistribution of frozen vaccine is not allowed because it is highly temperature
sensitive. MMRV and/or varicella must be shipped directly to all sites, including
satellite clinics, without going to a parent clinic first.
Storing vaccine
• Must store with enough space for cold air circulation around it.
• Must store in the middle of the compartment, two to three inches away from the coils,
walls, floor and cold air vent. The temperature near the floor and walls of the unit
differs from that in the middle of the compartment and the cold air vent can freeze
refrigerated vaccines.
• Must not be stored in the door or drawers of the refrigerator or freezer.
• Store ice packs in the freezer and water bottles in the doors, on the floor and near
the cold air vent in the refrigerator to help maintain a stable temperature if there is a
power failure and when the door is opened frequently. Too many water bottles in the
door can prevent the door from closing tightly.
• Mark water bottles “Do Not Drink.”
• If vaccine is stored in a household combination refrigerator/freezer, the top shelf
should not be used for storing vaccine because the cold air vent blowing from the
freezer will freeze vaccine located there. If you must use the top shelf of this type
of unit to store vaccine, place water bottles underneath the cold air vent to prevent
vaccine from being stored there.
• Must not store food or beverages in the refrigerator or freezer because frequent
opening of doors can lead to temperature variations that may affect vaccine viability.
There is also a risk of contaminating vaccines.
• Vegetable bins and crisper drawers should be removed from refrigerators or use
them for storing other medical supplies or water bottles.
• Open trays and baskets should be used to organize vaccines.
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• Each container should be clearly labeled with the vaccine type.
• Do not store “look-alike”and “sound-alike” vaccines next to each other (e.g., Tdap and
DTaP, HepA and HepB and Hib).
• Vaccines should be kept in their original packaging to protect them from light. This will
also help prevent medication errors and provide additional protection in case of an
out-of-range temperature, power outage, door left open, or mechanical failure.
• Safeguard the power supply:
○○ You must label the refrigerator/freezer and electrical outlets with “Do Not Unplug”
stickers (available from the MnVFC program).
○○ Fuse box and/or circuit breakers for vaccine storage units must be labeled
with “WARNING” stickers (available from the MnVFC program) to prevent any
disruption of the power to vaccine storage units.
○○ Make sure the refrigerator/freezer is plugged into an outlet where it can’t be
accidentally unplugged. An outlet that has a safety lock plug is ideal. If your
building has auxiliary power, use the outlet supplied by that system.
○○ Refrigerators/freezers must be plugged directly into an electrical outlet. Do not
use ground fault interrupter (GFI) outlets, extension cords, or power strips.
Monitoring temperatures twice a day
• The temperature in each refrigerator/freezer must be checked and recorded twice a
day at each clinic site, every day the clinic is open.
• The date, time, and name or initials of the individual checking the temperatures must
be recorded with each temperature reading. Check the temperature first thing in the
morning and just before you leave and record it on a temperature log specific to the unit.
• If you are recording the twice a day temperature checks in an electronic continuous
monitoring system, you must be able to produce a report of the twice a day
temperature checks and provide a copy to the MnVFC program if requested.
• Minimum and maximum temperatures should be assessed and documented for
each storage unit at the beginning of each clinic day. The minimum and maximum
temperatures should be reset, if needed, after recording them.
• Must keep temperature logs for three years.
• At any time, the MnVFC program may ask you to fax a copy of temperature logs to spot
check temperature control, or to assist in troubleshooting and diagnosing problems.
• If you fail to check and record temperatures twice a day, the MnVFC program will
hold your vaccine orders until you can verify that the vaccine storage unit has stable
temperatures and you are consistently recording temperatures twice a day.
• In addition to monitoring temperatures, a physical inspection of the storage unit
should be performed twice daily. An inspection should include the following:
○○
○○
○○
○○
○○
Thermometer probe is located in the center of the unit with the vaccine.
Vaccines are in their original boxes.
Vaccines are stored away from the walls, coils, or vents.
No vaccine is stored in the door or in the drawers.
The door of the unit is tightly closed.
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Taking immediate action on out-of-range temperatures and mishaps
• If you find an out-of-range temperature, you must take immediate action:
○○ Determine the problem; it might be easily corrected (e.g., door not shut, power
outage, unit malfunction, etc.).
○○ Stop using the vaccine and mark it “Do Not Use”, so it is not inadvertently
administered.
○○ Move the vaccine to a functioning vaccine storage unit.
○○ Gather information for the vaccine manufacturer: lot numbers, expiration dates,
temperature logs, and the amount of time the unit could have been out-of-range.
○○ Call the vaccine manufacturers. Ask to speak to a medical consultant or quality
assurance staff.
○○ Call the MnVFC program at 651-201-5522 to report out-of-range temperature incidents.
○○ Use a Vaccine Storage Unit Troubleshooting Log (available at www.health.state.
mn.us/divs/idepc/immunize/hcp/provguide/mangvax.html) or a form that your facility
has developed to document out-of-range temperatures and the actions you take in
response. Keep these logs for three years.
• When an out-of-range temperature mishap occurs the MnVFC program may hold
your vaccine orders until all issues are resolved.
• All vaccine received through MnVFC that becomes nonviable or lost must be reported
to MDH. Spoiled or expired vaccine in its original vial or pre-filled syringe must be
returned to McKesson Distribution within six months of expiration. (See section 11.)
Consequences of mishandling vaccine
• If vaccine has been exposed to out-of-range temperatures due to staff negligence or
failure to correctly store and handle it, you may be required to replace any wasted
doses that are from the MnVFC program. (See section 19.)
• If you must revaccinate patients because nonviable vaccine has been administered,
you may be responsible for covering the cost of vaccine needed to revaccinate. The
MnVFC program may not be able to supply the additional doses. (See section 19.)
• You may be required to replace lost vaccine doses (see section 19), provide staff
training, and/or review and revise your related policies if you:
○○ fail to ensure that vaccines are promptly stored when received,
○○ leave vaccine doses out overnight,
○○ leave the refrigerator/freezer door open overnight, or
○○ fail to follow appropriate procedures for transporting vaccine.
• If storage and handling incidents occur due to negligence, your participation in the
MnVFC program may be suspended.
• To re-establish your participation after being suspended, the MnVFC program may
require any or all of the following:
○○
○○
○○
○○
Providing additional staff training.
Documenting your policies and procedures to prevent future problems.
Faxing temperature logs to the MnVFC program.
Other options as appropriate.
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10. Keep privately purchased vaccine separate from MnVFC vaccine.
Keep privately purchased vaccine separate from MnVFC vaccine in order to make sure
MnVFC vaccine is only given to eligible patients.
• Draw the dose from the MnVFC supply when you see a patient who is eligible for
MnVFC vaccine.
• Must clearly mark the MnVFC boxes or vials or keep them in a clearly marked open
tray or basket.
• Monitor your inventory to make sure the MnVFC vaccine can be used before it
expires.
• MnVFC vaccine can only be used for MnVFC eligible patients.
Note: if your site uses the replacement method of vaccine management rather than separate
stock, you must follow the requirements in the MnVFC Replacement Clinics: Policies and
Procedures Manual.
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11. Manage MnVFC vaccine inventory efficiently.
• Have a written vaccine management plan. See appendix B: MnVFC Vaccine
Management Checklist for what must be included in this plan.
• The vaccine management plan must include the annual date of review and the
reviewer's name, title, and signature.
• Take monthly vaccine inventory, order only the amount of vaccine you need, rotate
stock, and transfer vaccine that’s due to expire to prevent wasting vaccine.
• Call the MnVFC program at 651-201-5522 if you have vaccine that will expire in three
months and you will not be able to use it.
• Report all MnVFC vaccine that becomes nonviable or lost to MDH.
• Return all spoiled or expired vaccine in its original vial or pre-filled syringe to
McKesson Distribution within six months of expiration.
• Report all MnVFC vaccine that is transferred to another site to the MnVFC program.
• Use Appendix H: VFC Vaccine Borrowing Report to document when vaccine is
borrowed from MnVFC stock to administer to a non MnVFC-eligible child or when
private stock is borrowed to administer to a MnVFC-eligible child and when the
vaccine is replaced to the appropriate stock.
Have a written plan for vaccine management*
• The vaccine management plan must include:
○○ Designation of an immunization manager, a vaccine coordinator, and back-ups.
○○ Proper vaccine storage and handling including appropriate vaccine storage
equipment, appropriate thermometers, and temperature monitoring.
○○ Vaccine shipping information, including receipt of vaccine orders and transporting
vaccines.
○○ Vaccine ordering procedures.
○○ Vaccine inventory control procedures to follow to avoid vaccine expiring or spoiling
resulting in loss of viable vaccine.
○○ Emergency plan for relocation of vaccine in the event of a power outage, natural
disaster, office moving locations, or a storage unit failure. (See Appendix C:
Worksheet for Developing an Emergency Plan for Managing Vaccine.)
○○ Staff training on vaccine management, including storage and handling.
○○ An annual review date and the reviewer's name, title, and signature.
• The vaccine management plan, including the emergency plan, must be reviewed
annually or more often if there are changes in staff responsibilities for fulfilling the tasks.
* This manual can fulfill this requirement, if staff read the entire manual and sign page 1.
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Taking monthly inventory
• Physical inventory of your MnVFC vaccine must be done at least monthly and before
placing a vaccine order. Record the number of doses and lot numbers and rotate
vaccine with the shortest expiration date to the front to be used first to prevent wasted
vaccine.
• You will need to record the number of doses in your current inventory on your vaccine
orders.
• You may be required to replace MnVFC vaccine that was unused due to over
ordering. (See section 19.)
Ordering only the amount of vaccine you actually need
• Avoid stockpiling or build-up of excess vaccine.
• Make sure you are using the correct vaccine order form; pediatric or varicella.
• There are two ways to order MnVFC vaccine that can be found at:
www.health.state.mn.us/divs/idepc/immunize/vaxorder.html
○○ MIIC: order vaccine online through the Minnesota Immunization Information
Connection (MIIC). If your clinic is not set up for ordering in MIIC, contact the MIIC
Regional Coordinator (www.health.state.mn.us/divs/idepc/immunize/registry/map.
html) that serves your region to get started.
○○ Paper: use the most current vaccine order form from the MnVFC website and
follow the instructions on it.
• You must include current refrigerator/freezer temperatures with each order.
Rotating stock
• Vaccine must be rotated with the monthly inventory.
• Make sure that vaccine due to expire first is in front so it will be used first. Expired
vaccine is money wasted!
• You may be required to replace MnVFC vaccine that expired because you failed to
rotate it. (See section 19.)
Transferring vaccine
• You must call the MnVFC program if you have vaccine that will expire within three
months that you cannot use.
• To prevent wasting MnVFC vaccine, you are responsible for transferring any
vaccine you will be unable to use to another MnVFC provider before it expires. One
exception:
○○ Redistribution of frozen vaccines (MMRV and varicella) is not permitted by either
the manufacturer or MnVFC. Call the MnVFC program for guidance.
• Only full, sealed vials or unopened prefilled syringes can be redistributed.
• Once a clinic has been identified, call them to make sure they can use the vaccine,
they have space to store it, and someone will be there to receive it.
• Report all MnVFC vaccine that is transferred to another site to the MnVFC program.
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• Fill out the MDH Vaccine Transfer Record form found at www.health.state.mn.us/
divs/idepc/immunize/mnvfc/transfer.pdf. Keep one copy, enclose one copy with the
vaccine, and send one copy to the MnVFC program.
• Whether you are sending or receiving a vaccine transfer, you must keep your copy of
the MDH Vaccine Transfer Record form for three years.
• Follow CDC and manufacturer specifications for maintaining the recommended
temperature range (35°-46°F or 2°-8°C) during transport of vaccine. Information on
packing for transport is available in the CDC’s Vaccine Storage and Handling Toolkit
found at www.cdc.gov/vaccines/recs/storage/toolkit/default.htm.
• You may be required to replace MnVFC vaccine that spoils due to staff negligence or
failure to correctly transport it. (See section 19.)
Borrowing vaccine
• The Appendix G: VFC Vaccine Borrowing Report must be used to document every
time MnVFC vaccine is borrowed to administer to a non-eligible patient or when
private stock is used for a MnVFC-eligible child. Document why the vaccine is
borrowed and the date the vaccine is replaced. This should be a rare, unplanned
occurrence.
Returning nonviable vaccine
• Call MnVFC at 651-201-5522 for guidance if you have any spoiled or expired MDH
vaccine.
• Nonviable vaccine needs to be returned no later than six months after the expiration
date. For example, a MnVFC vaccine that expires on 1/1/13 would need to be
returned before 7/1/13.
• Once you have MnVFC approval, return all spoiled and expired MnVFC vaccine
to McKesson following the instructions on the Nonviable MDH Vaccine form;
www.health.state.mn.us/divs/idepc/immunize/mnvfc/vfcret.pdf. Send one copy of the
completed Nonviable MDH Vaccine form to McKesson with the vaccine, send one
copy to the MnVFC program, and keep one copy for your records.
• You may be required to replace MnVFC vaccine that spoiled or expired due to
negligence. (See section 19.)
• The following should be reported to MDH but not returned to McKesson Specialty
Distribution. Follow your internal procedure for disposing of these nonviable vaccines.
○○
○○
○○
○○
○○
syringes filled but not used,
any used syringes with or without needles attached,
broken vials,
any multidose vial from which some doses have already been withdrawn, or
any doses that are more than six months past the expiration date.
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12. Post an emergency plan for managing vaccine.
• Have an emergency plan, which is reviewed annually, for transporting and storing
vaccine in an emergency situation such as power outage, natural disaster, or unit
failure.
• The emergency plan must include the annual date of review, the reviewer's name,
title, and signature.
• Refer to Appendix C: Worksheet for Developing an Emergency Plan for Managing
Vaccine to develop your own site-specific plan for storing and transporting vaccines in
a power outage or other emergency.
• When you need to manage vaccine during or after an incident, you can use
Immunization Action Coalition’s (IAC’s) Emergency Response Worksheet (Appendix
D) to record the vaccine, lot numbers, and expiration dates for vaccines that were
affected by a move or a power outage.
• Be sure your plan includes procedures for situations when you will have some lead
time (for example, when you know your office is moving) as well as those when you
have no lead time (for example, a sudden power outage, a natural disaster, or a
vaccine storage unit failure/malfunction).
• Be sure your plan identifies an alternate site (for example, a hospital or long-term
care facility) that has a backup generator to store your vaccine in case of a lengthy
power outage.
• If there is no hospital or long-term care facility with a backup generator in your area,
contact a pharmacy or grocery store to pre-arrange vaccine storage in the event of a
disaster or mishap.
• The plan must be reviewed with staff each year, or when staff change, and updated
as needed.
• The emergency plan should be practiced on a routine basis to ensure everything is in
place and the appropriate staff know what to do with the vaccine.
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13. Post an anaphylaxis protocol.
•Develop, post, and follow an anaphylaxis protocol, which is reviewed annually, so you
are prepared to respond to an emergency related to vaccine administration.
• The anaphylaxis protocol must include the annual date of review, the reviewer's
name, title, and signature.
• An anaphylaxis protocol must be posted in the area where vaccines are administered.
For an example of a protocol, see Appendix E: Medical Management of Vaccine
Reactions in Children and Teens and Appendix F: Medical Management of Vaccine
Reactions in Adult Patients, by the Immunization Action Coalition.
• The protocol must be reviewed annually and re-signed by your medical director.
• Review the protocol with all staff that administer vaccine and care for patients who
receive vaccine – both when you hire them and each year after that.
• All staff who administer vaccines should be currently certified in cardiopulmonary
resuscitation (CPR). (General Recommendations on Immunizations; January 28,
2011, Vol. 6/No. 2, page 12)
• Emergency supplies, and staff trained on how to use them, must be readily available
where vaccines are administered.
• Assign a staff member to check that emergency supplies have not expired on a
monthly basis and to replenish supplies after an anaphylaxis event has occurred.
• Assign a staff member to submit a report to VAERS, http://vaers.hhs.gov, in the event
of an adverse reaction following vaccine administration. (See section 5.)
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14. Assign an immunization manager and a vaccine coordinator.
• Designate an immunization manager (also designated as the MnVFC “mailing
contact”) and backup to oversee site administrative immunization activities.
• Designate a vaccine coordinator (also designated as the MnVFC “shipping contact”)
and backup to oversee ordering and vaccine management activities.
• Have written immunization staff responsibilities. (This manual can fulfill this
requirement, if staff read the entire manual and sign page 1.)
• Notify the MnVFC Program at [email protected] if the immunization manager
or vaccine coordinator changes.
• The immunization manager, vaccine coordinator, and backups must complete the
required annual MnVFC online training.
Note: The immunization manager and vaccine coordinator may be the same person in
a small practice as long as there is a backup for them.
Immunization manager (and backup) must:
• Be the point person for immunization-related activities in each facility that administers
vaccine to patients.
• Communicate with the MnVFC program. (This person will receive regular
communications from the MnVFC program by mail, phone, email, and fax. They will
need to share some of it with other staff.) Sign up to receive MnVFC announcements
directly to your email at www.health.state.mn.us/divs/idepc/immunize/mnvfc/bfax.html
and click the envelope near the top of the page.
• Train other staff who have vaccine-related responsibilities and keep a log to
document attendance.
• Develop policies and procedures related to immunizations, including an anaphylaxis
protocol. (See Appendices D and E for samples.)
• Review temperature logs weekly.
• Develop and post an emergency plan for managing vaccine in the event of a power
outage, storage unit failure, natural disaster, etc. (See Appendix C: Worksheet for
Developing an Emergency Plan for Managing Vaccine.)
• Complete the annual MnVFC online training. See page 36 for more information.
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Vaccine coordinator (and backup) must:
• Make sure vaccines are ordered, received, stored, and handled properly.
• Document or designate other staff to document the temperature in each refrigerator/
freezer twice daily.
• Conduct inventory of vaccines at least monthly and with each order.
• Keep a file of vaccine inventory logs and packing slips.
• Keep a list of names and phone numbers of key contacts like the generator repair
company and packing materials suppliers.
• Assist in developing and updating policies and procedures related to vaccine
management.
• Complete the annual MnVFC online training. See page 36 for more information.
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15. Follow up on feedback you receive from site visits.
• Receive a MnVFC site visit every one to two years to ensure that you are meeting
MnVFC program requirements.
• Follow up on improvement or corrective plans you receive as a result of the MnVFC
site visit.
• Cooperate with MnVFC staff performing an unscheduled storage and handling site
visit if your clinic is selected to be visited.
MnVFC site visits
• You will receive a site visit by an MDH or local public health staff person, called an
Immunization Practice Improvement (IPI) advisor, at least once every two years.
• They offer you support and guidance and ensure you are meeting the federal and
state MnVFC requirements listed in this manual.
• Site visits take about two hours, depending on your needs.
• The IPI advisor will:
○○ Contact you in advance of each visit.
○○ Encourage you to invite other staff members who could contribute to the visit.
○○ Bring resource materials to the visit.
○○ Discuss your clinic’s immunization strengths.
○○ Make recommendations to enhance your immunization practices and support MnVFC program requirements.
○○ Assess your immunization rates using MIIC. (Knowing your rates gives you an
opportunity to review your immunization practices and develop an action plan to
improve them.)
○○ Provide you with a site visit summary.
• If your clinic is not meeting a specific program requirement, they will work with you
to develop a corrective action plan that you will need to follow within a specified time
frame, usually 30 days.
• You may also receive a follow-up phone call, email, letter, or an additional site visit,
depending on your needs.
• You may also call on IPI advisors and MnVFC staff for in-service training, guidance in
developing policies and procedures, and troubleshooting vaccine-related concerns.
Storage and handling site visits
• The MnVFC program is required by CDC to perform unscheduled storage and
handling visits to serve as “spot checks” for proper storage and handling practices.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Be Accountable in the MnVFC Program
• These visits ensure all VFC-eligible children are receiving properly managed vaccines
and provide education about requirements and best practices related to storage and
handling.
• MnVFC-enrolled clinics will be prioritized and selected to receive an unscheduled site
visit based on the provider’s previous history of storage and handling issues and time
since the last MnVFC site visit.
Consequences of not meeting MnVFC requirements
• If you fail to take action to meet corrective-plan objectives, the MnVFC program may
suspend your participation in the program. However, to avoid that, the MnVFC staff
will work with you to develop a plan to remedy the situation.
• Repeated incidences of not meeting MnVFC program requirements could be
considered as fraud and/or abuse and handled accordingly. (See sections 18 and 19.)
MnVFC Program: 651-201-5522
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MnVFC Separate Stock Manual, 2015
Page 36
How to Be Accountable in the MnVFC Program
16. Renew your enrollment in MnVFC each year.
• Each MnVFC clinic site must complete and sign a MnVFC Program Provider
Agreement form and submit it to the MnVFC program by November 30.
Note: Each site that stores and administers MnVFC vaccine must be enrolled in the
MnVFC program and have its own personal identification number (PIN) number. Each
PIN number must have a signed MnVFC Program Provider Agreement.
• The clinic’s immunization manager, vaccine coordinator, and backups must complete
MnVFC online training annually by November 30.
Annual re-enrollment
• Complete and sign the MnVFC Program Provider Agreement, including the list
of additional providers in your practice, and have your site manager and medical
director sign it.
• If you fail to submit the MnVFC Program Provider Agreement by November 30, the
MnVFC program will hold your vaccine orders until you submit it.
• Each year the site must indicate the immunization manager, vaccine coordinator, and
backups have completed the MnVFC online training by checking the appropriate box
on the MnVFC Program Provider Agreement.
• New MnVFC enrollees: If you do not place your first vaccine order within 90 days of
enrolling, you will have to re-enroll, receive another enrollment site visit, and re-submit
your order.
Annual MnVFC online training
• Your site’s immunization manager, vaccine coordinator, and backups must complete
MnVFC online training each year by November 30. This training highlights the MnVFC
program requirements and storage and handling best practices.
• After completing the training, print the completion certificate and keep it with your
other MnVFC documents for three years.
• The online training is available on the MnVFC Program website at www.health.state.
mn.us/vfc.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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How to Be Accountable in the MnVFC Program
17. Submit an annual report.
Submit an annual report.
Annual report of the number of patients given MnVFC vaccine
• Complete an Annual Report of the Number of Patients Immunized with Vaccine from
MDH and send it to the MnVFC program by November 30. This report should cover
October 1 of the preceding year through September 30 of the year the report is due.
This report is a count of the number of eligible patients who received MnVFC vaccine
during the previous 12-month period.
• Count each patient only once for the entire year, regardless of the number of visits.
• If a patient was eligible at any time during the previous 12 months, count them only
once in the category they fall into first, in descending order as listed on the report.
• Consider working with your regional MIIC staff or local public health agency for
suggestions on how to collect data for your annual report.
• If you fail to submit your annual report by the deadline, the MnVFC program will hold
your vaccine orders until you submit it.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
Page 38
How to Be Accountable in the MnVFC Program
18. Avoid fraud and abuse.
• Take responsibility for being aware of and following MnVFC requirements.
• Call the MnVFC program if you have questions about MnVFC requirements and procedures.
• Cooperate with any investigation/inquiry related to potential fraud and abuse of the
MnVFC program and any related follow-up requirements, such as additional staff training.
Potential fraud and abuse
• Fraud is an intentional deception or misrepresentation made by a person with the
•
•
•
•
•
knowledge that the deception could result in some unauthorized benefit to himself or
some other person.
Abuse is provider practices that are inconsistent with sound fiscal, business, or
medical practices, and result in an unnecessary cost to the Medicaid program, or
in reimbursement for services that are not medically necessary or that fail to meet
professionally recognized standards for health care.
The MnVFC program will formally investigate all instances of possible fraud and
abuse on a case-by-case basis to differentiate between intentional fraud and abuse
and unintentional abuse or error due to excusable lack of knowledge.
If you have not met MnVFC requirements or followed MnVFC procedures as
outlined in this manual, but the MnVFC program finds no intentional deception,
misrepresentation, or negligence on your part, you may be required to participate in
training and/or to take other actions to rectify the situation.
If the MnVFC program finds evidence of intentional deception, misrepresentation,
or negligence on your part the situation will be further investigated for potential
enforcement of relevant laws including fraud and abuse, consumer protection, and
professional licensure.
Examples of potential fraud and/or abuse:
○○ Providing MnVFC vaccine to non-eligible patients.
○○ Selling or otherwise misdirecting MnVFC vaccine.
○○ Billing a patient or third party for MnVFC vaccine.
○○ Charging more than the maximum allowable charge for administration of a MnVFC vaccine.
○○ Not providing MnVFC vaccine to an eligible patient because they are unable to
pay the administration fee.
○○ Not meeting MnVFC enrollment requirements.
○○ Failing to screen patients for MnVFC eligibility.
○○ Failing to maintain MnVFC records.
○○ Failing to fully account for MnVFC vaccine.
○○ Failing to properly store and handle MnVFC vaccine.
○○ Ordering MnVFC vaccine in quantities or patterns that do not match your provider
profile or over-ordering MnVFC doses.
○○ Wasting MnVFC vaccine.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
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MnVFC Separate Stock Manual, 2015
How to Be Accountable in the MnVFC Program
19. Replace MnVFC vaccine wasted due to negligence.
MnVFC vaccine that has been wasted due to negligence must be replaced on a
dose for dose basis with privately purchased vaccine. Note: If nonviable vaccine was
administered, you may also be required to purchase vaccine needed to re-vaccinate
patients.
Replacing wasted MnVFC vaccine
• The MnVFC program will review all instances of spoiled or expired MnVFC vaccine
on a case-by-case basis. This review will help determine whether negligence was
involved.
• Negligent wasting of vaccine is considered to be fraud and abuse of the MnVFC
program. (See section 18.)
• If negligence is found and restitution is necessary, the MnVFC program will send you
a letter informing you of the number of doses of each vaccine that must be replaced.
• You must replace vaccine upon receipt of the notification letter. The MnVFC program
will stop supplying you with MnVFC vaccine until all of the nonviable vaccine is
replaced.
• Providers must submit receipt of purchase to the MnVFC program within 90 days
demonstrating that all doses were replaced appropriately.
• You may file an appeal with the MnVFC program by mail or fax if you believe you can
offer proof that the waste of vaccine was not due to negligence.
○○ Either use the MDH Vaccine Restitution Appeal Form (Appendix G) or include the
same information contained on the form.
○○ The appeal must be signed by your medical director or by your local health
director if you are a public health department.
• Examples of situations that may require restitution:
○○ Failure to rotate or transfer vaccine that results in expired vaccine, and the
MnVFC program was not notified at least three months before the vaccine’s
expiration date.
○○ Drawing up vaccine before screening patients.
○○ Leaving vaccine out of the refrigerator/freezer so it becomes nonviable.
○○ Freezing vaccine meant to be refrigerated.
○○ Refrigerating vaccine meant to be frozen.
○○ Leaving a refrigerator or freezer unplugged or an electrical breaker switched off.
○○ Leaving a refrigerator or freezer door open or ajar, whether by staff, contractors,
or guests.
○○ Not repairing or replacing a broken refrigerator/freezer immediately.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
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How to Be Accountable in the MnVFC Program
○○ Failing to act according to your posted disaster recovery plan in a power outage.
○○ Discarding vaccines, including multi-dose vials, that have not expired.
○○ Failure to report compromised vaccine shipments to McKesson within two hours
of receipt.
• Examples of situations that do not require restitution, because they are out of your
control:
○○ A vaccine shipment is not delivered to you in a timely manner or is otherwise
damaged during transit.
○○ An alarm/alert company does not notify you of an alarm.
○○ You move vaccine to a location with a secure power source in anticipation of
inclement weather, but power is lost at that location.
○○ You are unable to take action during a power outage (for example, during a
blizzard).
○○ A vial is accidentally dropped or broken.
○○ Vaccine is drawn after screening for contraindications and parental education, but
not administered due to parental refusal or a change in the physician orders.
○○ Other situations occur which the MnVFC program finds to be beyond your control.
Note: Always consult with the MnVFC program before deciding that vaccine is nonviable.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
Contacts
and
Resources
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
MnVFC Separate Stock Manual, 2015
Page 42
Contacts and Resources
Phone/Fax
CDC Immunization Information Contact Center, for general immunization and vaccine
questions:
• 800-232-4636 (English and Spanish)
• 800-232-6348 (TTY)
MnVFC Program
• Phone: 651-201-5522
• Fax: 651-201-5501
MDH Immunization Program, for Minnesota-specific questions, including MnVFC,
Minnesota Immunization Information Connection (MIIC), Minnesota School Law, and to order
immunization materials:
• Toll free phone: 800-657-3970
• Metro: 651-201-5503
• Fax: 651-201-5501
Web
• MDH MnVFC home page. Includes MnVFC overview, forms used by MnVFC providers, and
an archive of update notices sent to MnVFC providers.
www.health.state.mn.us/vfc
• MDH Immunization home page. Contains links to other pages listed below.
www.health.state.mn.us/immunize
• MDH Got Your Shots? A Providers Guide to Immunization in Minnesota has all the
information needed to make sure patients are properly immunized and vaccine is stored
correctly. www.health.state.mn.us/divs/idepc/immunize/hcp/provguide/index.html
• Manufacturer phone numbers from the Immunization Action Coalition’s Vaccine Policy and
Licensure web pages at www.immunize.org/fda
• MDH immunization information for health care providers.
www.health.state.mn.us/divs/idepc/immunize/hcp/index.html
• MDH Minnesota Immunization Information Connection (MIIC) Registry.
www.health.state.mn.us/divs/idepc/immunize/registry/index.html
• Immunization Action Coalition. Non-profit agency that provides CDC-approved resource
materials, including: vaccine immunization statements (VIS’s) in 32 languages; screening
questionnaires, newsletter for health professionals, anaphylaxis standing orders. 651-647-9009.
www.immunize.org
• CDC National Center for Immunization and Respiratory Diseases. Includes links to VFC
program, vaccine safety information, resource materials for parents and health professionals,
and information on the National Childhood Vaccine Injury Act. www.cdc.gov/vaccines
• CDC Vaccine Storage and Handling. Online training videos and resource materials including
checklists, logs, records, and posters. www.cdc.gov/vaccines/recs/storage
• VAERS reporting information. Report online or download the report form.
http://vaers.hhs.gov; phone 800-822-7967; toll-free fax 1-877-721-0366.
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
Appendices
A. Clinic Billing Office Tips for MnVFC
www.health.state.mn.us/divs/idepc/immunize/mnvfc/billingtips.pdf
B. MnVFC Vaccine Management Checklist, Minnesota Department of Health
C. Worksheet for Developing an Emergency Plan for Managing Vaccine,
Minnesota Department of Health
www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf
D. Emergency Response Worksheet, Immunization Action Coalition
www.immunize.org/catg.d/p3051.pdf
E. Medical Management of Vaccine Reactions in Children and Teens, Immunization Action Coalition
www.immunize.org/catg.d/p3082a.pdf
F. Medical Management of Vaccine Reactions in Adult Patients, Immunization Action Coalition
www.immunize.org/catg.d/p3082.pdf
G. MDH Vaccine Restitution Appeal Form, Minnesota Department of Health
www.health.state.mn.us/divs/idepc/immunize/mnvfc/mnvfcrestfm.pdf
H. VFC Vaccine Borrowing Report, Centers for Disease Control and Prevention
www.health.state.mn.us/divs/idepc/immunize/mnvfc/vfcborrowrpt.pdf
MnVFC Program: 651-201-5522
www.health.state.mn.us/vfc
[Appendix A]
Clinic Billing Office Tips for MnVFC
Minnesota Vaccines for Children Program
The Minnesota Vaccines for Children (MnVFC) program provides vaccine for MnVFC-eligible children at clinics
enrolled in the program. Your clinic billing office may get calls from patients who have questions about MnVFC
or who request that you adjust their bill for vaccination(s) because they are eligible for MnVFC. Here are some
tips for handling those situations.
Tip #1: Please be prepared to respond to
questions about MnVFC eligibility.
Your clinic screens patients to find out if they are
eligible for MnVFC before giving them
immunizations and keeps that screening
information on file. For up-to-date details on
eligibility, see the MnVFC Patient Eligibility
Screening Record forms at
www.health.state.mn.us/vfc. Click on MnVFC
Forms and select the form for your clinic type.
The MnVFC program has a self-screening form for
children that parents can fill out called Can my child
get free or low-cost shots? You might find it a
useful reference as well.
Permissible MnVFC vaccine
administration fees
Patient’s
status
MnVFC
eligible?
Permissible
administration
fee
Medicaid
eligible1
Yes
$21.22/dose
Uninsured2
Yes
$21.22/dose
American
Indian/Alaska
native
Yes
$21.22/dose
Underinsured3
Only at LPH,
FQHC,
RHC, IHS,
and tribal
health clinics
$21.22/dose
Privately
insured
No
Usual and
customary
Tip #2: Charge only allowable fees for
MnVFC.
There are three costs associated with each
immunization, the cost of:
• the vaccine,
• administering the vaccine, and
• the office visit.
MnVFC covers the cost of vaccines by providing
vaccine to clinics. Since this vaccine is provided to
your clinic at no charge, you cannot charge the
patient for the cost of this vaccine. In addition, the
program caps the administration fee you may
charge MnVFC-eligible patients at $21.22 per dose
(not per vaccine antigen) for MnVFC vaccine. This
fee limit is set by federal law. You may also charge
for the office visit.
To be reimbursed for the administration fee for
patients enrolled in a Minnesota Heath Care
Program (MHCP), you must follow the billing
procedures of each program. MHCP programs
include Medical Assistance (MA), MinnesotaCare,
or a Prepaid Medical Assistance Program (PMAP).
Forbillingquestions,calltheMinnesota
Department of Human Services (DHS) at 651-4312700.
MnVFC Program
P.O. Box 64975
St. Paul, MN 55164-0975
651-201-5522 or 1-800-657-3970
www.health.state.mn.us/vfc
1
Minnesota Health Care Program (MHCP) enrollee:
MN Medical Assistance (MA), MinnesotaCare, or a
Prepaid Medical Assistance Program (PMAP)
2
Does not have any insurance
3
Patients with private insurance that does not cover
the vaccine itself or has a cap. These children are
only MnVFC eligible at local public health (LPH),
Federally Qualified Health Centers (FQHC), Rural
Health Centers (RHC), Indian Health Services (IHS),
and tribal health clinics.
Preventive services like immunizations are often
covered even if a deductible remains. If the vaccine
is covered or would be denied because they need to
pay a deductible, the child will not be considered to
be “underinsured” for MnVFC purposes.
(8/14) Page 1 of 2
[Appendix A]
Billing Office Tips on MnVFC
Tip #3: Be prepared to remove vaccine
charges from a MnVFC-eligible patient’s
bill.
Patients that are uninsured, on a MHCP, or are
American Indian/Alaska native should have the
vaccine charges removed from the bill at all sites
that participate in MnVFC.
Underinsured children should have vaccine
charges removed if seen at public clinics (LPH,
FQHC, RHC, IHS, and tribal health clinics).
Tip #4: Waive the administration fee if a
patient is unable to pay it.
MnVFC-eligible patients may not be denied vaccine
for failure to pay an administration fee. You may bill
a patient for the administration fee, but if they are
unable to pay this fee it should be removed from
their bill. Having these bills go to collections is not
acceptable.
Tip #5: Make sure you enter the correct
CPT code for each vaccine.
This not only affects the patient’s bill but also their
shot record in the statewide immunization registry,
which is often derived directly from billing data.
Tip #6: Call the MnVFC program if you
have complex billing issues.
Wewillbehappytohelp:
651-201-5522 or 1-800-657-3970.
ForbillingquestionsaboutMHCPprograms,call
DHS at 651-431-2700.
Minnesota Department of Health – MnVFC Program
(8/14) Page 2 of 2
[Appendix B]
MnVFC Vaccine Management Checklist
MnVFC providers should have written procedures for managing MnVFC vaccine, including ordering vaccine,
monitoring inventory, and avoiding vaccine wastage. At a minimum, written procedures for vaccine
management should include:
1. Establishing a primary vaccine coordinator and at least one back-up staff
 Assigning and training the vaccine coordinator and back-up staff
 Listing of position responsibilities
2. Proper vaccine storage and handling
 Monitoring and recording storage unit temperatures twice daily
 Placing of the thermometer probe in the center of the storage unit
 Proper placement of vaccines in the storage unit
 Keeping vaccines in their original packaging
3. Vaccine shipping
 Receiving vaccine
 Transporting vaccine
4. Vaccine ordering
 Conducting a minimum of monthly inventory to prevent vaccine wastage and over-ordering of
vaccine
 Rotating vaccine stock so vaccine with the earliest expiration date is used first
5. Preventing vaccine wastage
 Calling the MnVFC program if MnVFC vaccine will expire within 3 months and will not be used
 Returning all non-viable MnVFC vaccine to McKesson (by calling the MnVFC program)
6. Planning for vaccine storage emergencies
 Planning for vaccine relocation in the event of a power outage, storage unit failure or natural
disaster such as a tornado, flooding, etc.
7. Reviewing and updating the vaccine management procedures and emergency plan annually and
as needed.
Date reviewed
Reviewed by name
Title
Signature
Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
651-201-5522, 1-800-657-3970
www.health.state.mn.us/vfc
(8/14)
[Appendix C]
Worksheet for Developing an Emergency Plan
for Managing Vaccine
In advance of an emergency, complete this worksheet and store it in an easily
accessible area near vaccine storage unit(s).
Emergency Plan for Managing Vaccine
Checklist of essential items:
‰ Designated primary and backup vaccine coordinators with emergency contact
information
‰ Emergency staff contact list in order of priority
‰ Vaccine storage unit specifications (type, brand, model number, serial number)
‰ Alternate vaccine storage facility(s)
‰ Written protocols and identified vehicles and drivers for transporting vaccine to
and from the alternate vaccine storage facility(s)
‰ Written instructions for how to enter your facility and access vaccine storage
units if the building is closed or it’s after hours. Include the building security afterhours access procedure, a floor diagram, and the locations of:
• Doors
• Flashlights
• Spare batteries
• Light switches
• Keys
• Locks
• Alarms (including instructions for use)
• Circuit breakers
• Packing materials
‰ Written protocol for vaccine packing
‰ Appropriate packing materials to safely transport and/or temporarily store vaccine
‰ Written protocol for appropriately storing vaccine at the alternate storage
facility(s)
‰ Up-to-date list of manufacturer quality control office phone numbers
MDH Immunization Program: 651-201-5522
(8/14) Page 1 of 4
[Appendix C
Worksheet for Developing an Emergency Plan for Managing Vaccine
(8/14) Page 2 of 4
Vaccine Coordinators
Phone Numbers
(home, cell)
Name
Email
(work, home)
Primary
Backup
Emergency Staff Contact List
Emergency Role
(driver, vaccine packer, etc.)
Name (list in order of priority)
Phone Numbers
(home, cell)
1.
2.
3.
4.
5.
6.
Vaccine Storage Unit Specifications
Type of Unit
(refrigerator or freezer)
MDH Immunization Program: 651-201-5522
Brand
Model Number
Serial Number
www.health.state.mn.us/immunize
[Appendix C]
Worksheet for Developing an Emergency Plan for Managing Vaccine
(8/14) Page 3 of 4
Emergency Resources Contact List
Emergency Resources
Company Name
Contact Person
Phone Numbers
Electric power company
Generator repair company
Generator fuel source
Refrigeration repair company
Local Health Department
State Health Department
Immunization Program
800-657-3970
651-201-5501
State Health Department
MnVFC Program
651-201-5522
Alternate Vaccine Storage Facility(s)
Facility Name
Contact Person
Phone Numbers
Storage Capacity
Transportation to Alternate Vaccine Storage Facility(s)
Company Name
Contact Person
Phone Numbers
Refrigerated vehicle company
Refrigerated vehicle company
(alternate)
Private vehicle
Private vehicle (alternate)
MDH Immunization Program: 651-201-5522
www.health.state.mn.us/immunize
[Appendix C]
Worksheet for Developing an Emergency Plan for Managing Vaccine
(8/14) Page 4 of 4
Packing Materials
Company Name
Contact Person
Phone Numbers
Insulated containers or
coolers
Insulated containers or
coolers (alternate)
Fillers (e.g., bubble wrap, brown
packing paper, newspaper)
Fillers (alternate)
Cold / frozen packs
Cold / frozen packs (alternate)
Dry ice vendor
(if inventory includes MMRV,
varicella, or zoster vaccine)
Dry ice vendor (alternate)
Certified, calibrated
thermometers
Certified, calibrated
thermometers (alternate)
Based on CDC’s Emergency Vaccine Retrieval and Storage Plan Worksheet from the Storage and Handling Toolkit.
www2a.cdc.gov/vaccines/ed/shtoolkit/resources/Emerg_Vac_Rtrvl_Strg_Plan_Worksheet.htm
Date reviewed
Reviewed by name
Title
Signature
MDH ImmunizationProgram: 651-201-5522
www.health.state.mn.us/immunize
[Appendix D]
Emergency Response Worksheet
What to do in case of a power failure or other event that results in vaccine storage outside of the
recommended temperature range
Follow these procedures:
1. Close the door tightly.
2. Ensure the vaccine is kept at appropriate temperatures. Make sure the refrigerator or freezer is plugged in and working properly, or move the vaccines
into proper storage conditions as quickly as possible.
3. Do NOT discard the affected vaccines unless directed to by your state/
local health department and/or the manufacturer(s). Label the vaccines
“Do Not Use” so that the potentially compromised vaccines can be easily
identified.
4. Notify the state/local health department or call the manufacturer (see
manufacturers’ phone numbers below).
5. Document the inventory of affected vaccines below and document the
circumstances of the event and the actions taken on the Vaccine Storage
Troubleshooting Record (see www.immunize.org/catg.d/p3041.pdf).
e
l
p
Vaccines Stored in Refrigerator
Vaccine
Manufacturer
Lot #
Expiration Date
m
a
# of Doses (i.e., not # of vials)
Vaccines Stored in Freezer
S
Vaccine
Manufacturer
Lot #
Expiration Date
# of Doses (i.e., not # of vials)
Important Contact Information:
Vaccine Manufacturers
Crucell Vaccine Inc.1
(800) 533-5899
CSL Biotherapies, Inc. (refer to Merck)
Emergent BioSolutions2 (877) 246-8472
GlaxoSmithKline
Intercell Biomedical3
MedImmune, Inc.
Merck & Co., Inc.!
Manufacturer for less commonly used vaccine:
1. typhoid
2. anthrax
3. Japanese encephalitis
$Questions on Afluria (CSL Biotherapies, Inc.) should be directed to Merck & Co., Inc.
(888) 825-5249
(301) 556-4500
(877) 633-4411
(800) 672-6372
Novartis Vaccines
Pfizer Inc.
Protein Sciences Corp.
sanofi pasteur
(800) 244-7668
(800) 438-1985
(800) 488-7099
(800) 822-2463
Health Departments
Local Health Department phone
Adapted by the Immunization Action Coalition, courtesy of the Michigan Department of Community Health
State Health Department phone
Technical content reviewed by the Centers for Disease Control and Prevention
Immunization Action Coalition Saint Paul, Minnesota • 651- 647- 9009 • www.vaccineinformation.org • www.immunize.org
www.immunize.org/catg.d/p3051.pdf • Item #P3051 (2/14)
[Appendix E]
Medical Management of Vaccine Reactions in Children and Teens
All vaccines have the potential to cause an adverse reaction. To minimize adverse reactions, patients should be carefully
screened for precautions and contraindications before vaccine is administered. Even with careful screening, reactions can
occur. These reactions can vary from trivial and inconvenient (e.g., soreness, itching) to severe and life threatening (e.g.,
anaphylaxis). If reactions occur, staff should be prepared with procedures for their management. The table below describes procedures to follow if various reactions occur.
Reaction
Symptoms
Management
Localized
Soreness, redness, itching, or swelling at the
injection site
Apply a cold compress to the injection site. Consider
giving an analgesic (pain reliever) or antipruritic (antiitch) medication.
Slight bleeding
Apply an adhesive compress over the injection site.
Continuous bleeding
Place thick layer of gauze pads over site and maintain
direct and firm pressure; raise the bleeding injection
site (e.g., arm) above the level of the patient’s heart.
Fright before injection is given
Have patient sit or lie down for the vaccination.
Extreme paleness, sweating, coldness of the
hands and feet, nausea, light-headedness, dizziness, weakness, or visual disturbances
Have patient lie flat or sit with head between knees
for several minutes. Loosen any tight clothing and
maintain an open airway. Apply cool, damp cloths to
patient’s face and neck.
Psychological
fright and
syncope
(fainting)
m
a
Fall, without loss of consciousness
Examine the patient to determine if injury is present
before attempting to move the patient. Place patient
flat on back with feet elevated.
Loss of consciousness
Check the patient to determine if injury is present before attempting to move the patient. Place patient flat
on back with feet elevated. Call 911 if patient does not
recover immediately.
S
Anaphylaxis
e
l
p
Sudden or gradual onset of generalized itching,
erythema (redness), or urticaria (hives);
angioedema (swelling of the lips, face, or
throat); severe bronchospasm (wheezing);
shortness of breath; shock; abdominal
cramping; or cardiovascular collapse
See “Emergency Medical Protocol for Management
of Anaphylactic Reactions in Children and Teens” on
the next page for detailed steps to follow in treating
anaphylaxis.
(page 1 of 3)
Technical content reviewed by the Centers for Disease Control and Prevention, July 2011.
www.immunize.org/catg.d/p3082a.pdf • Item #P3082a (7/11)
Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org
[Appendix E]
Medical Management of Vaccine Reactions in Children and Teens (continued)
(page 2 of 3)
Supplies you may need at a community immunization clinic

First-line treatment: Aqueous
epinephrine 1:1000 dilution, in
ampules, vials of solution, or prefilled
syringes, including epinephrine autoinjectors (e.g., EpiPen). If EpiPens
are to be stocked, both EpiPen Jr.
(0.15 mg) and adult EpiPens (0.30 mg)
should be available.

Secondary treatment option:
Diphenhydramine (Benadryl)
injectable (50 mg/mL solution) or
oral (12.5 mg/5 mL liquid, 25 or 50 mg
capsules/tablets)

Syringes: 1 and 3 cc, 22–25g, 1",
1½", and 2" needles for epinephrine
and diphenhydramine (Benadryl)

Alcohol wipes

Tourniquet

Pediatric & adult airways (small,
medium, and large)

Sphygmomanometer (blood pressure
measuring device) child, adult
and extra-large cuffs)

Tongue depressors

Flashlight with extra batteries (for
examination of mouth and throat)

Wrist watch with ability to count
seconds

Cell phone or access to an onsite
phone
e
l
p

Pediatric & adult size pocket masks
with one-way valve

Oxygen (if available)

Stethoscope
Emergency medical protocol for management of anaphylactic reactions in children and teens
m
a
1. If itching and swelling are confined to the injection site where the vaccination was given, observe patient closely for the
development of generalized symptoms.
2. If symptoms are generalized, activate the emergency medical system (EMS; e.g., call 911) and notify the on-call physician.
This should be done by a second person, while the primary nurse assesses the airway, breathing, circulation, and level of
consciousness of the patient.
3. Drug Dosing Information:
a. First-line treatment: Administer aqueous epinephrine 1:1000 dilution (i.e., 1 mg/mL) intramuscularly; the standard dose
is 0.01 mg/kg body weight, up to 0.3 mg maximum single dose in children and 0.5 mg maximum in adolescents (see chart
on next page).
S
b. Secondary treatment option: For hives or itching, you may also administer diphenhydramine either orally or
by intramuscular injection; the standard dose is 1–2 mg/kg body weight, up to 30 mg maximum dose in children
and 50 mg maximum dose in adolescents (see chart on next page).
4. Monitor the patient closely until EMS arrives. Perform cardiopulmonary resuscitation (CPR), if necessary, and maintain
airway. Keep patient in supine position (flat on back) unless he or she is having breathing difficulty. If breathing is
difficult, patient’s head may be elevated, provided blood pressure is adequate to prevent loss of consciousness. If blood
pressure is low, elevate legs. Monitor blood pressure and pulse every 5 minutes.
5. If EMS has not arrived and symptoms are still present, repeat dose of epinephrine every 5–15 minutes for up to 3 doses,
depending on patient’s response.
6 Record all vital signs, medications administered to the patient, including the time, dosage, response, and the name of the
medical personnel who administered the medication, and other relevant clinical information.
7. Notify the patient’s primary care physician.
(page 2 of 3)
www.immunize.org/catg.d/p3082a.pdf • Item #P3082a (7/11)
Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org
2a (7/11)
[Appendix E]
Medical Management of Vaccine Reactions in Children and Teens (continued)
(page 3 of 3)
For your convenience, approximate dosages based on weight and age are provided in the charts below. Please
confirm that you are administering the correct dose for your patient.
First-Line Treatment: Epinephrine (the recommended dose for epinephrine is 0.01 mg/kg body weight)
Age Group
Infants
and
Children
Teens
Range of weight
(lb)
Range of weight
(kg)*
1–6 months
9–19 lb
4–8.5 kg
7–36 months
20–32 lb
9–14.5 kg
37–59 months
33–39 lb
15–17.5 kg
5–7 years
40–56 lb
18–25.5 kg
8–10 years
57–76 lb
26–34.5 kg
11–12 years
77–99 lb
35–45 kg
13 years & older
100+ lb
46+ kg
Epinephrine Dose
1 mg/mL injectable
(1:1000 dilution)
intramuscular
Minimum dose: 0.05 mL
EpiPen (Dey, L.P.)
Epinephrine
auto-injector 0.15 mg
or 0.3 mg
0.05 mL (or mg)
off label
0.1 mL (or mg)
off label
0.15 mL (or mg)
0.15 mg
e
l
p
0.2–0.25 mL (or mg)
0.15 mg
0.25–0.3 mL† (or mg)
0.15 mg or 0.3 mg
0.35–0.4 mL (or mg)
0.3 mg
0.5 mL (or mg)‡
0.3 mg
Note: If body weight is known, then dosing by weight is preferred. If weight is not known or not readily available, dosing by age is appropriate.
*Rounded weight at the 50th percentile for each age range
†
Maximum dose for children
‡
Maximum dose for teens
m
a
Secondary Treatment Option: Diphenyhydramine (the recommended dose
for diphenhydramine [Benadryl] is 1–2 mg/kg body weight)
Age Group
S
Infants
and
Children
Teens
Range of weight
(lb)
Range of weight
(kg)*
Diphenhydramine Dose
12.5 mg/5 mL liquid
25 mg or 50 mg tablets
50 mg/mL injectable (IV or IM)
7–36 months
20–32 lb
9–14.5 kg
10 mg–20 mg
37–59 months
33–39 lb
15–17.5 kg
15 mg–30 mg†
5–7 years
40–56 lb
18–25.5 kg
20 mg–30 mg†
8–12 years
57–99 lb
26–45 kg
30 mg†
13 years & older
100+ lb
46+ kg
50 mg‡
Note: If body weight is known, then dosing by weight is preferred. If weight is not known or not readily available, dosing by age is appropriate.
*Rounded weight at the 50th percentile for each age range
†
Maximum dose for children
‡
Maximum dose for teens
Sources
Boyce JA, Assa’ad A, Burks AW, et al. Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the NIAID-Sponsored Expert
Panel. Allergy Clin Immunol 2010; 126(6):S1–S57.
Simons FE, Camargo CA. Anaphylaxis: Rapid recognition and treatment. In: UpToDate, Bochnew BS (Ed). UpToDate: Waltham, MA, 2010.
These standing orders for the medical management of vaccine reactions in child and teenage patients shall remain in effect for
patients of the
Medical Director’s signature
.
until rescinded or until
date
name of clinic
Effective date
www.immunize.org/catg.d/p3082a.pdf • Item #P3082a (7/11)
Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org
[Appendix F]
Medical Management of Vaccine Reactions in Adult Patients
All vaccines have the potential to cause an adverse reaction. In order to minimize adverse reactions, patients should be carefully screened for precautions and contraindications before vaccine is administered. Even with careful screening, reactions
may occur. These reactions can vary from trivial and inconvenient (e.g., soreness, itching) to severe and life threatening
(e.g., anaphylaxis). If reactions occur, staff should be prepared with procedures for their management. The table below
describes procedures to follow if various reactions occur.
e
l
p
Reaction
Symptoms
Management
Localized
Soreness, redness, itching, or swelling at
the injection site
Apply a cold compress to the injection site.
Consider giving an analgesic (pain reliever) or
antipruritic (anti-itch) medication.
Psychological
fright and
syncope
(fainting)
m
a
Slight bleeding
Apply an adhesive compress over the injection site.
Continuous bleeding
Place thick layer of gauze pads over site and
maintain direct and firm pressure; raise the
bleeding injection site (e.g., arm) above the level
of the patient’s heart.
Fright before injection is given
Have patient sit or lie down for the vaccination.
S
Anaphylaxis
Extreme paleness, sweating, coldness of
the hands and feet, nausea, light-headedness, dizziness, weakness, or visual
disturbances
Have patient lie flat or sit with head between
knees for several minutes. Loosen any tight
clothing and maintain an open airway. Apply
cool, damp cloths to patient’s face and neck.
Fall, without loss of consciousness
Examine the patient to determine if injury is
present before attempting to move the patient.
Place patient flat on back with feet elevated.
Loss of consciousness
Check the patient to determine if injury is
present before attempting to move the patient.
Place patient flat on back with feet elevated.
Call 911 if patient does not recover immediately.
Sudden or gradual onset of generalized
itching, erythema (redness), or urticaria
(hives); angioedema (swelling of the lips,
face, or throat); severe bronchospasm
(wheezing); shortness of breath; shock;
abdominal cramping; or cardiovascular
collapse.
See “Emergency Medical Protocol for
Management of Anaphylactic Reactions in
Adults” on the next page for detailed steps to
follow in treating anaphylaxis.
(continued on page 2)
Technical content reviewed by the Centers for Disease Control and Prevention
www.immunize.org/catg.d/p3082.pdf • Item #P3082 (11/13)
Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org
[Appendix F]
(page 2 of 2)
Medical Management of Vaccine Reactions in Adults (continued)
Supplies you may need at a community immunization clinic

Syringes (1 and 3 cc) and needles

First-line treatment: Aqueous
(22 and 25g, 1”, 1½”, and 2”) for
epinephrine 1:1000 (i.e., 1 mg/mL)
epinephrine and diphenhydramine
dilution, in ampules, vials of solution, or
(Benadryl). For ampules, use filtered
prefilled syringes, including epinephrine
needles.
autoinjectors (e.g., EpiPen and Auvi-Q).
If autoinjectors are stocked, at least

Alcohol wipes
three should be available.

Tourniquet
Secondary treatment option:


Adult airways (small, medium, and
Diphenhydramine (Benadryl)
large)
injectable (50 mg/mL solution) or

Adult size pocket mask with one-way
oral (12.5 mg/5 mL liquid, 25 or 50 mg
valve
capsules/tablets)

Oxygen (if available)

Stethoscope

Sphygmomanometer (blood pressure
measuring device) with adult-size and
extra-large cuffs

Tongue depressors

Flashlight with extra batteries (for
examination of the mouth and throat)

Wristwatch with ability to count
seconds

Cell phone or access to onsite phone
e
l
p
m
a
Emergency medical protocol for management of anaphylactic reactions in adults
1. If itching and swelling are confined to the injection site where the vaccination was given, observe patient
closely for the development of generalized symptoms.
2. If symptoms are generalized, activate the emergency medical system (EMS; e.g., call 911) and notify the patient’s
physician. This should be done by a second person, while the primary healthcare professional assesses the airway,
breathing, circulation, and level of consciousness of the patient.
3. Drug Dosing Information:
a. First-line treatment: Administer aqueous epinephrine 1:1000 dilution intramuscularly, 0.01 mL/kg/dose
(adult dose ranges from 0.3 mL to 0.5 mL, with maximum single dose of 0.5 mL).
b. Secondary treatment option: For hives or itching, you may also administer diphenhydramine either orally
or by intramuscular injection; the standard dose is 1–2 mg/kg, up to 50 mg maximum single dose.
4. Monitor the patient closely until EMS arrives. Perform cardiopulmonary resuscitation (CPR), if necessary, and
maintain airway. Keep patient in supine position (flat on back) unless he or she is having breathing difficulty.
If breathing is difficult, patient’s head may be elevated, provided blood pressure is adequate to prevent loss of
consciousness. If blood pressure is low, elevate legs. Monitor blood pressure and pulse every 5 minutes.
5. If EMS has not arrived and symptoms are still present, repeat dose of epinephrine every 5–15 minutes for up to
3 doses, depending on patient’s response.
6. Record all vital signs, medications administered to the patient, including the time, dosage, response, and the name
of the medical personnel who administered the medication, and other relevant clinical information.
7. Notify the patient’s primary care physician.
S
Sources
Simons FE, Camargo CA. Anaphylaxis: Rapid recognition and treatment. In: UpToDate, Bochner BS (Ed). UpToDate: Waltham, MA, 2013.
Boyce JA, Assa’ad A, Burks AW, et al. Guidelines for the Diagnosis and Management of Food Allergy in the United States: Report of the
NIAID- Sponsored Expert Panel. Allergy Clin Immunol 2010; 126(6):S1–S57.
These standing orders for the medical management of vaccine reactions in adult patients shall remain in effect for patients of the
until rescinded or until
.
name of clinic
Medical Director’s signature
date
Effective date
www.immunize.org/catg.d/p3082.pdf • Item #P3082 (11/13)
Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org
[Appendix G]
MDH Vaccine Restitution Appeal Form
To file a vaccine restitution appeal; complete this form or prepare a document that includes the
following information.
1. A detailed explanation of the circumstances surrounding the vaccine wastage, with
attachments as needed.
2. Proof that a situation resulting in the waste of vaccine was not due to negligence.
3. Signature of your lead physician if you are a private practice facility or of your local health
director if you are a public health department.
4. A copy of the letter from the MnVFC program informing you that restitution was needed.
Return the form/document by mail or fax to:
MDH Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
FAX: 651-201-5501
Facility Name: ______________________________________________________________
Address: __________________________________________________________________
MnVFC PIN Number:
________________________________________________________
Contact: ___________________________________________________________________
Phone: ____________________________________________________________________
Webelieveweshouldnotbeheldresponsibleforthevaccineandrequestreconsideration
for the following reason(s):
_____________________________________________________
Signature of physician or local health director
_________________
Date
For program use only
Decision rendered on:
Responsible:
By:
Not responsible:
Date notified:
Immunization Program
P.O. Box 64975
St. Paul, MN 55164-0975
651-201-5522, 1-800-657-3970
www.health.state.mn.us/vfc
(Revised 03/11)
VACCINE BORROWING REPORT
A dose of VFC vaccine is administered to a non VFC-eligible child
A dose of privately-purchased vaccine is administered to a VFC-eligible child
Reason for Borrowing VFC Dose
•
Reason for Borrowing Private Dose
VFC vaccine shipment delay (order placed on time/delay in shipping)
VFC vaccine not useable on arrival (vials broken, temperature monitor out of range)
Ran out of VFC vaccine between orders (not due to shipping delays)
Short-dated VFC dose was exchanged with private dose
Accidental use of a VFC dose for a child not eligible for the VFC program
Other – Describe:
Completed forms must be retained as a VFC program record and made available to the State/Local or Territorial Immunization Program upon request.
WHAT TO DO WITH THIS FORM:
1
2
3
4
5
6
7Other
Code
Reason for Vaccine Borrowing and Replacement Coding Legend
Enter information on each dose of vaccine borrowed in a separate row in the Vaccine Borrowing Report Table.
All columns must be completed for each dose borrowed
The provider must sign and date at the bottom of this report
Enter the corresponding reason code in column F of the Borrowing Report Table on page 2.
Enter details of reason in Column F if an Other code (7Other or 13Other) is entered in the Vaccine Borrowing Report Table.
Private vaccine shipment delay (vaccine order placed on time/delay in shipping)
Private vaccine not useable on arrival (vials broken, temperature monitor out of range)
Ran out of private vaccine between orders (not due to shipping delays)
Short-dated private dose was exchanged with VFC dose
Accidental use of Private dose for VFC eligible child
Replacement of Private dose with VFC when insurance plan did not cover vaccine
Other – Describe:
•
•
•
•
•
HOW TO COMPLETE THIS FORM:
•
•
COMPLETE THIS FORM WHEN:
(9/14) 1
8
9
10
11
12
13Other
Code
VFC-enrolled providers must ensure borrowing VFC vaccine will not prevent a VFC-eligible child from receiving a needed vaccination. Infrequent exchanging between
VFC and private stock of a short-dated vaccine dose may be performed if the provider serves a small number of private pay patients, the dose is one month from
expiration, or the dose of vaccine cannot be used for the population it is intended for prior to the expiration date.
VFC-enrolled providers are expected to manage and maintain an adequate inventory of vaccine for both their VFC and non-VFC-eligible patients. Planned borrowing
of VFC vaccine including the use of VFC vaccine as a replacement system for a provider’s privately purchased vaccine inventory is not permissible.
Facility Name:
Pin #:
[Appendix H]
B
Stock Used
(VFC or Private)
C
Patient Name
D
Patient DOB
(XX/XX/XXXX)
E
Date Dose
Administered
(XX/XX/XXXX)
F
Reason Appropriate Vaccine
Stock was not Used
(Use legend code on page 1 to mark
one reason for each dose borrowed)
G
Date Dose
Returned to
Appropriate Stock
(XX/XX/XXXX)
Provider Name:
Provider Signature:
Date:
(9/14) 2
I hereby certify, subject to penalty under the False Claims Act (31 U.S.C. § 3730) and other applicable Federal and state law, that VFC vaccine dose borrowing and
replacement reported on this form has been accurately reported and conducted in conformance with VFC provisions for such borrowing and further certify that all VFC
doses borrowed during the noted time period have been fully reported on this form.
A
Vaccine Type Borrowed
VACCINE BORROWING REPORT TABLE
Date Range of Vaccine Reporting (date of first dose borrowed to date of last dose borrowed): ____/____/______ to ____/____/______
[Appendix H]
Minnesota Department of Health
Immunization Program
625 N Robert Street
St. Paul, MN 55164-0975
www.health.state.mn.us/vfc
651-201-5522 or 1-800-657-3970
Fax: 651-201-5501