Minnesota Vaccines for Children

Minnesota Vaccines for Children Policies and Procedures Manual October 2011 - September 2012 Minnesota Department of Health Immunization Program 625...
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Minnesota Vaccines for Children

Policies and Procedures Manual October 2011 - September 2012

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

MnVFC Manual, 2011

Table of Contents

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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.

Screen patients for MnVFC eligibility........................................................... 6 Charge only allowable fees......................................................................... 9 Give patients a VIS with each immunization............................................. 11 Report adverse reactions to VAERS.......................................................... 12 Document immunizations in medical charts.............................................. 13 Keep MnVFC records for three years........................................................ 14

How to Manage the MnVFC Program 7. 8. 9. 10. 11. 12.

Have the right refrigerator/freezer(s) and thermometer(s)......................... 16 Receive and store vaccine carefully.......................................................... 19 Keep privately purchased vaccine separate from MnVFC vaccine........... 23 Manage MnVFC vaccine inventory efficiently............................................ 24 Post an emergency plan for managing vaccine......................................... 27 Post an anaphylaxis protocol..................................................................... 28

How to be Accountable in the MnVFC Program 13. 14. 15. 16. 17. 18.

Assign an immunization manager and a vaccine coordinator................... 30 Follow up on feedback you receive from site visits................................... 31 Renew your enrollment in MnVFC each year............................................ 32 Submit annual and semi-annual reports.................................................... 33 Replace MnVFC vaccine wasted due to negligence................................. 34 Avoid fraud and abuse............................................................................... 36

Contacts and Resources.................................................................38 Appendices.......................................................................................39 A. Billing Office Tips on MnVFC, Minnesota Department of Health B. Worksheet for Developing an Emergency Plan for Managing Vaccine, Minnesota Department of Health C. Emergency Response Worksheet, Immunization Action Coalition D. Medical Management of Vaccine Reactions in Adult Patients, Immunization Action Coalition E. Medical Management of Vaccine Reactions in Children and Teens, Immunization Action Coalition F. MnVFC Restitution Appeal Form, Minnesota Department of Health G. VFC Vaccine Borrowing Report, Centers for Disease Control and Prevention H. MnVFC Vaccine Management, Minnesota Department of Health MnVFC Program: 651-201-5522

www.health.state.mn.us/vfc

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MnVFC Manual, 2011

Signature Page Requirement As a MnVFC provider, it is a federal requirement that you have certain written immunization policies (on immunization staff assignments, emergencies, ordering and receiving vaccine, monitoring vaccine inventory, storing and handling vaccine, and vaccine wastage). You can use this manual to fulfill most of this requirement if:

• You attach your own emergency and anaphylaxis protocols to the manual. (See appendix of this manual for examples and resources.)

• Your immunization manager and vaccine coordinator and their backups read and sign this page, certifying that they have read the manual.

In addition, consider having all staff whose work relates to immunizations sign and date this page, indicating that they have read this manual (for example, the desk clerk who receives immunization shipments and the billing person). By signing below I certify that I have read this MnVFC manual. Name Immunization Manager:

Date

Backup Manager: Vaccine Coordinator: Backup Coordinator:

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Name

MnVFC Program: 651-201-5522

Date

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MnVFC Manual, 2011

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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. The program distributes about $38 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 patients. 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 the MnVFC program at 651-201-5522 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. Once the forms are received by the MnVFC program they will be reviewed for completeness. If any information is missing, the forms will be returned highlighting the missing information. 4. When the completed forms are returned, 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 the site visit is completed, any corrections are completed 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.

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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. Please note the Annual Provider Agreement is a legally binding contract. When you sign the Annual Provider Agreement you are agreeing to comply with all the points listed on the form and with appropriate immunization schedules, dosage, and contraindications established by state and federal recommending groups such as the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American Academy of Family Physicians, and the Minnesota Immunization Practices Advisory Committee.

MnVFC Program: 651-201-5522

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How to Administrate the MnVFC Program

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How to Administrate the MnVFC Program

1. Screen patients for MnVFC eligibility. Requirements • Screen each patient before administering vaccines to determine if they are eligible for MnVFC vaccine. • Remove vaccine charges from a MnVFC-eligible patient’s bill if their insurance denies payment for vaccine and the patient calls to request that their bill be adjusted. Screening patients for eligibility

• 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?)

• Document the screening information in a paper or electronic file so you can retrieve

it for MnVFC reports. (The MnVFC program has Patient Eligibility Screening Record forms you can use.)

• If you are not yet participating in the statewide immunization registry, the Minnesota Immunization Information Connection (MIIC), consider joining it to track MnVFC eligibility electronically. See www.health.state.mn.us/divs/idepc/immunize/registry.

• If the patient wants to call their insurance company to check on their coverage, please provide access to a phone.

• Review the eligibility criteria with the patient/parent before giving the shot. • If the patient has insurance, submit claims to their insurance company. If the claim

is denied, assign MnVFC eligibility and do not charge the patient for the cost of the vaccine. Replace private vaccine with MnVFC stock if the patient is found to be eligible.

• You are not required to verify the patient’s response to the screening questions. For example, if patients say they have reached their cap you do not need to call their insurance company to confirm.

Keeping paper records of eligibility screening

• Keep an eligibility screening record in the patient’s medical record (chart) or in a

separate file, (The MnVFC program provides screening record forms for children and adults on the web. 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. Be sure to date and initial the form for each visit to indicate that eligibility screening was completed.

• Keep the eligibility screening record for three years from the date of the last visit.

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Keeping electronic records for eligibility screening

• Keep the eligibility screening information in the patient’s electronic medical record

or in a separate database. This information must include the date(s) the patient was screened.

• Keep the eligibility screening information in the database for three years from the date of the last visit.

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 Billing Office Tips on MnVFC in the appendix of this manual.

• If a patient is potentially underinsured, tell them you will submit a claim to their

insurance company, and give them a phone number to call if they are billed for vaccines.

• You need to track the number of underinsured patients and include it on annual and semi-annual MnVFC reports. To capture this number electronically, you can either use MIIC or designate a separate code in your billing system.

MnVFC eligibility criteria Here is a general overview of MnVFC eligibility criteria. For up-to-date details, see the MnVFC Patient Eligibility Screening Record forms on the web at www.health.state.mn.us/vfc. Children from birth through 18 years • Uninsured • Enrolled in a Minnesota Health Care Program: Medical Assistance (MA), MinnesotaCare, or a Prepaid Medical Assistance Program (PMAP) • American Indian or Alaskan Native • 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 • Has health insurance with any unmet deductible; once the deductible has been paid, the person is no longer MnVFC-eligible

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Adults age 19 years and older • Clinics may provide certain vaccines received from MDH to adults enrolled in a Minnesota Health Care Program (MHCP), including: Medical Assistance (MA), MinnesotaCare, or a Prepaid Medical Assistance Program (PMAP). • Vaccines received from MDH and administered to adults enrolled in a MHCP must be billed to the patient’s MHCP using the SL-modifier. • Refer to the website, www.health.state.mn.us/vfc for current adult vaccine eligibility criteria. • Refer to the Minnesota Department of Human Services website, www.dhs.state.mn.us/dhs16_136660#P204_5660 for more information on billing.

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How to Administrate the MnVFC Program

2. Charge only allowable fees. Requirements • Charge only the allowable fees, set by federal law, for administering MnVFC vaccine. • Waive any administration fee on MnVFC vaccine if a patient is unable to pay. • Do not charge a patient for the cost of vaccine if they received MnVFC vaccine. Charging allowable administration fees

• You may charge MnVFC-eligible patients a fee of up to $14.69 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 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.

• If a patient’s insurance fails to pay for immunizations – either because they don’t

cover immunizations, or they cap immunization coverage at a certain amount and that cap has already been reached, or there is a deductible that has yet to be met – replace private vaccine with MnVFC vaccine and remove the vaccine charge from the patient’s bill. Then bill the patient the usual and customary administration fee.

Permissible MnVFC vaccine administration fees Patient’s status Minnesota Health Care Program (MHCP) Uninsured American Indian/Alaska native Underinsured*

Privately Insured

MnVFC eligible? Yes Yes Yes Yes No

Permissible administration fee $14.69/dose $14.69/dose $14.69/dose $14.69 at a federally qualified health center (FQHC) or a rural health center (RHC); usual and customary elsewhere Usual and customary

*Underinsured includes those whose health insurance: - Doesn’t include vaccines (MnVFC will pay for non-covered vaccines) - Caps vaccine coverage at a certain amount (MnVFC will pay for vaccines after that cap is reached) - Has a deductible that has yet to be met (MnVFC will pay for vaccines until the deductible is met)

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Waiving the administration fee

• No MnVFC-eligible patient may be denied vaccine for failure to pay an administration fee.

• You may bill patients for the 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.

Consequences of not meeting this requirement

• Not charging administrative fees according to MnVFC policy could be considered fraud and abuse. (See section 18 of this manual.)

• 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 ($14.69)

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3. Give patients a VIS with each immunization. Requirement According to federal law, you must provide a current Vaccine Information Statement (VIS) every time a patient receives a vaccine and document the publication date of the VIS and the date the VIS was given in the patient’s medical record. VISs are CDC fact sheets that inform vaccine recipients, or their parents or legal representatives of the benefits and risks of a vaccine.

• Give a VIS (either paper or electronic) to the patient or their parent or legal representative before administering each dose of vaccine.

• 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 CDC’s patient download website (www.cdc.gov/vaccines/pubs/vis/vis-downloads.htm) 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 on the web at no charge at www.cdc.gov/vaccines/pubs/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.

• 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.

• 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 a copy from the internet). 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, as a reminder, and a copy to take home.

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4. Report adverse reactions to VAERS. Requirement 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 all health care providers to 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 for a copy of form and help completing it, call VAERS at 800-822-7967 or visit http://vaers.hhs.gov.

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How to Administrate the MnVFC Program

5. Document immunizations in medical charts. Requirement Under federal law, you must document certain required information in each patient’s medical record for each dose of vaccine given.

• Include this federally required information: ○○ Clinic/facility address ○○ 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)

• Include the following information as well: ○○ 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

• 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-HIB) and the name of the combination vaccine (for example, TriHibit).

• You can order patient immunization record forms from the MnVFC program. • Be sure to give patients/parents a record of each immunization. Fill out an

immunization record card (available from MnVFC) or, if your clinic is enrolled in the Minnesota Immunization Information Connection (MIIC) print out the MIIC immunization record.

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6. Keep MnVFC program records for three years. Requirement Keep all records related to the MnVFC program for at least three years.

• Keep these records for at least three years: ○○ Temperature logs ○○ MnVFC eligibility screening information (forms or recorded in the electronic medical record) ○○ Troubleshooting logs ○○ MDH Vaccine Transfer Record forms ○○ Returning Nonviable MDH Vaccine forms, if you have used them ○○ Packing lists of vaccine shipments or logs with lot numbers ○○ Monthly inventory log ○○ Vaccine borrowing documentation

• If requested, make these records available to the MnVFC program. • Check with your own clinic’s policies about keeping records beyond three years. • Note: MnVFC forms are available on the web at www.health.state.mn.us/vfc.

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How to Manage the MnVFC Program

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7. Have the right refrigerator/freezer(s) and thermometer(s). Requirements • Have appropriate working vaccine refrigerator/freezer(s) to store vaccine. • The MnVFC program does not allow the use of combination refrigerator/freezers with one exterior door of any type for storing MnVFC vaccines, including dormitory style units. • Use a thermometer that is calibrated and has a current certificate of traceability* in each refrigerator/freezer used to store vaccine. • Have written procedures for use of an electronic monitoring system to assure it is properly maintained and staff responsibilities are designated. Note: If you are using an electronic monitoring system or the unit has an internal thermometer with digital display, it must be calibrated and have a current certificate of traceablity.*

Refrigerator/freezers must:

• Be appropriate for storing vaccine. • Preferred storage units, in order of preference are; ○○ Commercial lab or pharmacy grade unit, including: refrigerator-only, freezer-only or a combination refrigerator/freezer unit with separate exterior doors and separate controls ○○ Household stand alone freezer-less refrigerator and/or stand alone freezer ○○ Household style combination refrigerator/freezer built within the last 10 years, with separate doors and separate temperature controls Note: “Medical grade” unit indicates that it can be plugged in near oxygen; 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.

• 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).

• Be able to maintain required vaccine storage temperatures year-round: ○○ Refrigerator between 35-46°F (2-8°C), aim for 40ºF (4ºC) ○○ Freezer between -58°F and +5°F (-50°C -15°C), aim for 0ºF (-18ºC) *A certificate of traceability confirms that measurement standards and instruments used during calibration of the product are traceable to an ISO/IEC 17025 accredited testing laboratory, to NIST or to another internationally recognized standard agency. MnVFC Program: 651-201-5522

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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 yy Household-style combination refrigerator-freezer with separate exterior doors and separate controls in each compartment

• Be used only for vaccines. However: ○○ 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.

• Be plugged directly into a power outlet. Extension cords are not acceptable. • 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 replaced refrigerator/ freezer indicating that the temperature in it has stabilized in the appropriate range before additional vaccines are sent to you.

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Thermometers must:

• Be calibrated and have a current certificate of traceability*. The accuracy of

thermometers without this certificate cannot be guaranteed and are not acceptable. You may either use the thermometer(s) provided at no cost by the MnVFC program (a maximum of four per clinic) or an alternate version. Call the MnVFC program for specifications.

• Have the temperature sensor probe placed in the center of the refrigerator/freezer with the vaccine.

• If you use a continuous electronic monitoring system (examples: Temp Trak and Isensix) or your unit has a built-in thermometer, it must be calibrated and have a current certificate of traceability*. You must be able to provide documentation of calibration and a current certificate of traceability* to MnVFC staff or their representatives.

• If you are using a remote electronic monitoring system (examples: TempTrak, Isensix, Sensaphone) you must have written procedures identifying: ○○ Who is responsible for maintaining the system ○○ When and how the system is recalibrated ○○ Who responds to out-of-range temperatures and a 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)

• If you are using a “prover box”, or have biomedical personnel to recalibrate

thermometers or electronic monitoring systems, you must be able to provide documentation that the equipment used is calibrated and has a current certificate of traceability* with the date due for next calibration. *A certificate of traceability confirms that measurement standards and instruments used during calibration of the product are traceable to an ISO/IEC 17025 accredited testing laboratory, to NIST or to another internationally recognized standard agency.

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8. Receive and store vaccine carefully. Requirements • Have written procedures for receiving and storing vaccine in order to prevent loss of this temperature sensitive resource. (This manual can fulfill this requirement, if staff read the entire manual and sign page 1. See MnVFC Vaccine Management in the appendix for what should be included in the procedures.) • At the clinic site, manually check and record temperatures twice a day in all refrigerators and freezers used to store MnVFC vaccine – even if you have an electronic monitoring system. • Call the MnVFC program within two hours of receiving MnVFC vaccine that is compromised. • Take immediate action on out-of-range temperatures. • Call the MnVFC program and the vaccine manufacturers for help in determining the viability of vaccines that have been exposed to out-of-range temperatures.

Receiving vaccine shipments

• Check the condition of all vaccines immediately when they arrive. ○○ The vaccine should not be damaged. ○○ Cold or warm mark indicators should not be activated. ○○ The vaccines shipped should match those listed on the packing list.

• Refrigerated vaccines ○○ Should be cold but not frozen. (Note: MMR will arrive refrigerated from McKesson and MnVFC recommends storing it in the freezer.) ○○ If you have any question about the condition of a refrigerated vaccine when it arrives or if temperature monitors are activated, mark the vaccine “Do Not Use”, store it in the appropriate storage unit, and call McKesson at 877- 822-7746 within two hours of signing the receipt. (Note: McKesson is liable for any vaccine compromised during delivery, but only if reported to McKesson within two hours of receipt).

• Frozen vaccines ○○ Merck has replaced the use of dry ice with frozen gel packs in the shipping packages for Varivax. A predetermined number of gel packs, based on Merck validation testing, are placed in the shipping container to maintain proper temperatures for three days from the shipping date on the packing list. ○○ If more than three days have passed since the vaccine was shipped or you have any concerns about the condition of the vaccine, call Merck immediately at 1-800-637-2579. MnVFC Program: 651-201-5522

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• If you receive vaccine with an expiration date of six months or less, call the MnVFC program for guidance.

• Store vaccines at the right temperatures immediately after receiving them. Put those with the earliest expiration date in front to be used first.

• Report to MnVFC any discrepancies between what’s in the shipment and what’s

listed on the packing slip, for example, in the lot numbers, expiration dates, vaccine types, and number of doses.

• 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 an inventory logs for at least three years. • Because frozen vaccine is highly temperature sensitive, redistribution of these

vaccines to other sites is not allowed. MMRV and/or varicella must be shipped directly to all sites, including satellite clinics, without going to a parent clinic first.

Storing vaccine

• Store vaccine correctly: ○○ Do not store vaccine in the door or drawers of the refrigerator or freezer. ○○ Store inactivated vaccines in the middle of the refrigerator, far enough away from the cold air vent to protect them from freezing. ○○ Store vaccine in the middle of the compartment, two to three inches away from the coils, walls, floor and cold air vent because the temperature near the floor and walls of the unit differs from that in the middle of the compartment. ○○ Store ice packs in the freezer and water bottles in the refrigerator to help maintain a stable temperature if there is a power failure or the door is opened frequently. ○○ Mark water bottles “Do Not Drink”. ○○ Do 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. ○○ Remove vegetable bins and crisper drawers from refrigerators or use them for storing other medical supplies or water bottles. ○○ Use open, ventilated trays and baskets or other uncovered containers to organize vaccines. ○○ Clearly label each container with the vaccine type. Avoid storing “look-alike”and “sound-alike” vaccines next to each other (e.g., Tdap and DTaP, HepA and HepB and Hib). ○○ Keep vaccines in their original packaging to protect them from light, this also. provides additional protection in case of an out-of-range temperature, power outage, door left open, etc.

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• Safeguard the power supply: ○○ 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. ○○ Don’t plug refrigerators/freezers into ground fault interrupters (GFCI), extension cords, or power strips. ○○ Label the refrigerator/freezer, power cord, and electrical outlets with “Do Not Unplug” stickers. ○○ Know where your fuse box and/or circuit breakers are located. Label them with “WARNING” stickers (available from the MnVFC program) to prevent any disruption of the power to vaccine storage units. Monitoring temperatures twice a day

• Manually check the temperature in each refrigerator/freezer twice a day at each clinic

site, every day the clinic is open. Check the temperature first thing in the morning and just before you leave, and write it on a temperature log specific to the unit – even if you’re using an electronic monitoring system. Note: This is a CDC requirement.

• 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 monitor 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 for up to a week and/or 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 Taking immediate action on out-of-range temperatures and mishaps

• If you find an out-of-range temperature: ○○ Determine the problem; it might be easily corrected (e.g., door not shut, power outage, unit malfunction, etc.). ○○ Adjust the thermostat slightly, if necessary. ○○ Check the temperature every 30 minutes until it stabilizes in the correct range. ○○ If the temperature doesn’t stabilize in the correct range within two hours, stop using the vaccine, mark it “Do Not Use”, move the vaccine to a functioning MnVFC Program: 651-201-5522

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refrigerator/freezer and have the unit repaired. Call the MnVFC program for guidance. Be ready to provide the current temperature and temperature log details. ○○ Use a Storage Unit Troubleshooting Log (available from MnVFC) to document outof-range temperatures and the actions you take in response. Keep these logs for three years. ○○ Note: When your freezer goes through a defrost cycle, the temperature may rise to 5º above the recommended temperature range lasting 20 – 60 minutes. There can be four (4) defrost cycles per day.

• If vaccine was exposed to out-of-range temperatures: ○○ Mark the vaccine “Do Not Use” and continue to store it at the proper temperatures until you can determine if it is viable. Do not throw it away!

• When an out-of-range temperature mishap occurs the MnVFC program will hold your vaccine orders until all issues are resolved.

• ALL vaccine received through MnVFC that becomes nonviable (i.e., spoiled or

expired) must be returned to McKesson Specialty Distribution. (See section 10 of this manual.)

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 reimburse the MnVFC program for it. (See section 17 of this manual.)

• 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 17 of this manual.)

• 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, you may be required to pay for the loss of vaccine (see section 17 of this manual), provide staff training, and/or to review and revise your related policies.

• 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 these:

○○ 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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9. Keep privately purchased vaccine separate from MnVFC vaccine. Requirement • Keep privately purchased vaccine separate from MnVFC vaccine in order to make sure MnVFC vaccine is only given to eligible patients. • 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 MnVFCeligible child.

• MnVFC vaccine can only be used for MnVFC eligible patients. • Clearly mark the MnVFC boxes or vials or keep them in a clearly marked open tray or basket.

• When you see a patient who is eligible for MnVFC vaccine, draw the dose from the MnVFC supply.

• Monitor your inventory to make sure the MnVFC vaccine can be used before it expires.

• 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 occurance. (See sample VFC Vaccine Borrowing Report in the appendix of this manual.)

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10. Manage MnVFC vaccine inventory efficiently. Requirements • Have written procedures, which are reviewed annually, for ordering vaccine, monitoring inventory, and avoiding vaccine wastage. (This manual can fulfill this requirement, if staff read the entire manual and sign page 1. See MnVFC Vaccine Management in the appendix for what should be included in the procedures.) • 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 if you have vaccine that will expire in three months and you will not be able to use it. • Return all spoiled and expired MnVFC vaccine to McKesson after getting authorization from MnVFC to do so.

Have written procedures for vaccine management

• Written vaccine management procedures should include: ○○ Designation of a primary vaccine coordinator and at least one back-up staff ○○ Proper vaccine storage and handling including appropriate vaccine storage equipment, appropriate thermometers, temperature monitoring, etc. ○○ 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, etc. (See Worksheet for Developing an Emergency Plan for Managing Vaccine in the appendix of this manual.) • Review these vaccine management procedures, including the emergency plan, annually or more often if there are changes in staff responsibilities for fulfilling the tasks.

Taking monthly inventory

• Take physical inventory of your MnVFC vaccine, recording the number of doses

and lot numbers, each month and before ordering vaccine. This will provide an opportunity to rotate your stock of vaccine with the shortest expiration date to the front to be used first and prevent wasted vaccine. • You will need to record the number of doses in your current inventory on your vaccine orders. • Note your vaccine usage patterns by checking packing slips against what you have in inventory. • You may be required to replace MnVFC vaccine that was unused due to over ordering. (See section 17 of this manual.) MnVFC Program: 651-201-5522

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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, MHCP adult or varicella. Do not order vaccine for MHCP adults using the pediatric form.

• There are two ways to order vaccine. ○○ Paper: use the most current vaccine order form from the MnVFC website; www.health.state.mn.us/vfc and follow the instructions on it. ○○ Online: go to https://idepc.health.state.mn.us/vfc_mn/ and sign in by entering your: -- Username (Your site’s MnVFC six-digit pin number (For example: E52001) -- Password: MNVFC10 -- Select the appropriate vaccine order form from the drop down menu

• You need to include current refrigerator/freezer temperatures with each order. Rotating stock

• 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 17 of this manual.)

Transferring vaccine that’s due to expire

• 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.

• You must call the MnVFC program if you have vaccine that will expire within three

months that you cannot use. Staff will help you find a clinic that can use the vaccine.

• 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.

• Fill out the MDH Vaccine Transfer Record form. 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, keep your copy of the MDH Vaccine Transfer Record form for three years.

• Only full, sealed vials or unopened prefilled syringes can be redistributed. • 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 from the MnVFC program.

• You may be required to replace MnVFC vaccine that spoils due to staff negligence or failure to correctly transport it. (See section 17 of this manual.)

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Returning nonviable vaccine

• Call MnVFC for guidance if you have any spoiled or expired vaccine. • Once you have MnVFC approval, return all spoiled and expired MnVFC vaccine to

McKesson following the instructions on the Returning Nonviable MDH Vaccine form; www.health.state.mn.us/divs/idepc/immunize/mnvfc/vfcret.pdf. Send one copy of the completed Returning 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 17 of this manual.)

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11. Post an emergency plan for managing vaccine. Requirement Post an emergency plan, which is reviewed annually, for transporting and storing vaccine in an emergency situation such as a power outage, natural disaster or unit failure.

• Refer to the Worksheet for Developing an Emergency Plan for Managing Vaccine

in the appendix of this manual 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 (see appendix) 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.

• Go over the plan with staff each year and update it as needed.

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12. Post an anaphylaxis protocol. Requirement Develop, post, and follow an anaphylaxis protocol, which is reviewed annually, so you are prepared to respond to an emergency related to vaccine administration.

• Post an anaphylaxis protocol where vaccines are administered. For an example of a protocol, see Medical Management of Vaccine Reactions in Children and Teens and Medical Management of Vaccine Reactions in Adult Patients, by the Immunization Action Coalition, in the appendix of this manual.

• Review the protocol annually and have it 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)

• Keep emergency supplies readily available where vaccines are administered and train staff how to use them.

• Assign a staff member to check weekly to make sure there are emergency supplies that have not expired 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 4 of this manual.)

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How to be Accountable in the MnVFC Program

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13. Assign an immunization manager and a vaccine coordinator. Requirements • Designate an immunization manager (also designated as the MnVFC “mailing contact”) to oversee clinic immunization activities. • Designate a vaccine coordinator (also designated as the MnVFC “shipping contact”) and back-up. • Have written immunization staff responsibilities. (This manual can fulfill this requirement, if staff read the entire manual and sign the signature page on page 1.) 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 responsibilities

• 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.)

• Train other staff who have vaccine-related responsibilities and keep a log to document attendance.

• Develop policies and procedures related to immunization, including an anaphylaxis

protocol. (See sample Medical Management of Vaccine Reactions in the appendix of this manual.)

• Review temperature logs weekly. • Develop and post an emergency plan for managing vaccine. (See Worksheet

for Developing an Emergency Plan for Managing Vaccine in the appendix of this manual.)

Vaccine coordinator (and backup) responsibilities

• Make sure vaccines are ordered, received, stored, and handled properly. • Document or designate other staff to document the temperature in each refrigerator/ freezer and adjust the temperature as needed.

• Conduct inventory of vaccines 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.

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14. Follow up on feedback you receive from site visits. Requirements • Receive a MnVFC site visit every one to two years to demonstrate that you are meeting MnVFC program requirements. • Follow up on improvement or corrective plans you receive in the MnVFC site visit. MnVFC site visits Every year or two you will receive a site visit by an MDH or local public health staff person called an Immunization Practice Improvement (IPI) advisor. These advisors have special expertise in vaccine management, vaccine storage and handling, and immunization best practices. Their intention is to offer you support and guidance and to assure that you are meeting the federal and state MnVFC requirements listed in this manual. Site visits usually take about two hours, depending on your needs. Your IPI advisor will contact you in advance of each visit and will encourage you to invite other staff members who could contribute to the visit. The IPI advisor will bring resource materials to the visit and will discuss your clinic’s immunization strengths and make recommendations to enhance your immunization practices and support MnVFC program requirements. Using the immunization registry, MIIC, the IPI advisor will assess your immunization rates. Knowing your rates gives you an opportunity to review your immunization practices and develop an action plan to improve them. After the site visit, you will receive a written report from the IPI advisor. If the advisor finds that 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. 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 vaccinerelated concerns. 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 9 and 17 in this manual.)

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15. Renew your enrollment in MnVFC each year. Requirement Each MnVFC clinic site must complete and sign an Annual Provider Agreement form and submit it to the MnVFC program no later than November 30 each year. Note: Each site that administers MnVFC vaccine must be enrolled in the MnVFC program and have its own PIN number. Each PIN number must have a signed Annual Provider Agreement. Annual re-enrollment

• Complete the Annual Provider Agreement form, including the list of additional

providers in your practice, and have your clinic manager and medical director sign it.

• If you fail to submit an Annual Provider Agreement by the due date, the MnVFC program will hold your vaccine orders until you submit it.

• Have immunization staff read and sign the current MnVFC Policy and Procedures Manual.

• Complete an annual report summarizing patients served by MnVFC over the previous year.

• 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.

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16. Submit annual and semi-annual reports. Requirement Submit annual and semi-annual reports to show that MnVFC vaccines are being used to provide vaccine to eligible patients.

Annual report of the number of patients given MnVFC vaccine

• Complete a Annual Report of the Number of MnVFC Patients Immunized and send it

to the MnVFC program by November 30 each year. This report should cover October 1 of the preceding year through September 30 of the year the report is due. This is an actual 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 as eligible for the correct category.

• 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.

• Be sure to complete a separate adult form for MHCP adults, if you serve them. Semi-annual report of doses administered to eligible adults

• If you administer MDH vaccine to eligible adult patients age 19 and older you must

complete the Semi-Annual Report of Doses Administered to MHCP Adults (19 years and older) every six months.

• The report covers the six-month period preceding the report due date. The report is due:

○○ May 31 (October 1 – March 31) ○○ November 30 (April 1 – September 30)

• Consider working with your regional MIIC staff or local public health agency for suggestions on how to collect data for semi-annual reports.

• If you fail to submit your semi-annual report by the deadline, the MnVFC program will hold your vaccine orders until you submit it.

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17. Replace MnVFC vaccine wasted due to negligence. Requirement MnVFC vaccine that has been wasted due to negligence must be replaced with privately purchased vaccine. Note: If nonviable vaccine was administered, you may also be required to replace vaccine needed to re-vaccinate patients, since MnVFC may not be able to provide the vaccine. 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.

• 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 MnVFC Restitution Appeal Form 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 ○○ Failing to act according to your posted disaster recovery plan in a power outage ○○ Discarding multi-dose vials that have not expired MnVFC Program: 651-201-5522

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○○ 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.

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18. Avoid fraud and abuse. Requirements • Take responsibility for being aware of and following MnVFC requirements and procedures. • Call the MnVFC program if you have questions about MnVFC requirements and procedures and if you unintentionally did not follow them. • 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

• 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 abuse: ○○ Providing MnVFC vaccine to non-eligible adults ○○ 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 adult 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

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Contacts and Resources

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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 • TTY: 651-201-5797 • 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 • 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 Storage and Handling Tool Kit. Online training videos and resource materials including checklists, logs, records, and posters. www2a.cdc.gov/vaccines/ed/shtoolkit/ • 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.

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Appendices

A. Billing Office Tips on MnVFC http://www.health.state.mn.us/divs/idepc/immunize/mnvfc/billingtips.pdf B. Worksheet for Developing an Emergency Plan for Managing Vaccine, Minnesota Department of Health http://www.health.state.mn.us/divs/idepc/immunize/hcp/worksheet.pdf C. Emergency Response Worksheet, Immunization Action Coalition http://www.immunize.org/catg.d/p3051.pdf D. Medical Management of Vaccine Reactions in Adult Patients, Immunization Action Coalition http://www.immunize.org/catg.d/p3082.pdf E. Medical Management of Vaccine Reactions in Children and Teens, Immunization Action Coalition http://www.immunize.org/catg.d/p3082a.pdf F. MnVFC Restitution Appeal Form, Minnesota Department of Health http://www.health.state.mn.us/divs/idepc/immunize/mnvfc/mnvfcrestfm.pdf G. VFC Vaccine Borrowing Report, Centers for Disease Control and Prevention http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/07-module-3.pdf H. MnVFC Vaccine Management, Minnesota Department of Health

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[Appendix A]

Billing Office Tips on MnVFC Minnesota Vaccines for Children Program

Your clinic is enrolled in the MnVFC program, through the Minnesota Department of Health. MnVFC pays for vaccine for un- and underinsured children. At the clinic billing office you 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. The MnVFC program has a self-screening form for children in several languages that parents can fill out, called Can my child get free or lowcost shots? You might find it a useful reference as well. Here is a general overview of MnVFC eligibility criteria. For up-to-date details, see the MnVFC Patient Eligibility Screening Record forms on the web at www.health.state.mn.us/vfc. Children from birth through18 years  Uninsured  Enrolled in a Minnesota Health Care Program: o Medical Assistance (MA), o MinnesotaCare, or a o Prepaid Medical Assistance Program (PMAP)  American Indian or Alaskan Native  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 MnVFC Program P.O. Box 64975 St. Paul, MN 55164-0975 651-201-5522 or 1-800-657-3970 Fax: 651-201-5501 www.health.state.mn.us/vfc

amount is reached, the person is MnVFC eligible  Has health insurance with any unmet deductible; once the deductible has been paid, the person is no longer MnVFC eligible Note: State law requires that Minnesota insurance companies cover immunizations without applying a deductible; this is called first-dollar coverage. Most Minnesotans who have health insurance will not have a deductible for immunizations and therefore will not be considered to be “underinsured” for MnVFC purposes. Tip #2: Charge only allowable fees for MnVFC. There are three costs associated with each immunization: the cost of the vaccine, the cost of administering the vaccine, and the cost of the office visit. MnVFC covers the cost of vaccines by providing free vaccine to clinics. In addition, the program caps the fee you may charge MnVFC-eligible patients at $14.69 per dose (not per vaccine 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 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). These programs will reimburse you for the contracted administration fee. (See table on page 2.) For billing questions, call the Minnesota Department of Human Services (DHS) at 651-431-2700.

(6/11) Page 1 of 2

[Appendix A] Billing Office Tips on MnVFC Tip #3: Be prepared to remove vaccine charges from a MnVFCeligible patient’s bill. If a patient is potentially underinsured the clinic should tell them it will submit a claim to their insurance company, and if the patient receives a bill for the cost of the vaccine they should contact the clinic billing department. If the patient’s insurance denies payment for vaccine, and the patient is eligible for MnVFC, you must remove vaccine charges from their bill. Again, due to our state’s first-dollar coverage law, this should be the exception and not the rule. 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. We will be happy to help:

Permissible MnVFC vaccine administration fees Permissible Patient’s MnVFC administration status eligible? fee Medicaid Yes $14.69/dose eligible Uninsured Yes $14.69/dose American Indian/Alaska Yes $14.69/dose native $14.69 at a federally qualified health center (FQHC) Underinsured* Yes or a rural health center (RHC); usual and customary elsewhere Privately Usual and No Insured customary * Underinsured: Patients with insurance that either does not cover vaccines, or that covers only selected vaccines (MnVFC eligible for non-covered vaccines only), or that caps vaccine coverage (eligible after cap is reached), or that has any unmet deductible (eligible before deductible has been met).

651-201-5522 or 1-800-657-3970

MnVFC Program P.O. Box 64975 St. Paul, MN 55164-0975 651-201-5522 or 1-800-657-3970 Fax: 651-201-5501 www.health.state.mn.us/vfc

(6/11) Page 2 of 2

[Appendix B]

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 MnVFC Program: 651-201-5522

Page 1 of 4

[Appendix B] Worksheet for Developing an Emergency Plan for Managing Vaccine

Page 2 of 4

Vaccine Coordinators Phone Numbers (home, cell)

Name

Email (work, home)

Primary Backup

Emergency Staff Contact List Name (list in order of priority)

Emergency Role (driver, vaccine packer, etc.)

Phone Numbers (home, cell)

1. 2. 3. 4. 5. 6.

Vaccine Storage Unit Specifications Type of Unit (refrigerator or freezer)

MnVFC Program: 651-201-5522

Brand

Model Number

Serial Number

www.health.state.mn.us/vfc

[Appendix B] Worksheet for Developing an Emergency Plan for Managing Vaccine

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)

MnVFC Program: 651-201-5522

www.health.state.mn.us/vfc

[Appendix B] Worksheet for Developing an Emergency Plan for Managing Vaccine

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

MnVFC Program: 651-201-5522

www.health.state.mn.us/vfc

[Appendix C]

Emergency Response Worksheet What to do in case of a power failure or another event that results in vaccine storage outside of the recommended temperature range Follow these procedures: 1. Close the door tightly and/or plug in the refrigerator/freezer. 2. Ensure the vaccine is kept at appropriate temperatures. Make sure the refrigerator/freezer is working properly or move the vaccines to a unit that is. Do not discard the affected vaccines. Mark the vaccines so that the potentially compromised vaccines can be easily identified. 3. Notify the local or state health department or call the manufacturer (see manufacturers’ phone numbers below). 4. Record action taken.

Record this information*:

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1. Temperature of refrigerator: current______ max.______ min.______ 2. Temperature of freezer: current______ max.______ min.______ 3. Air temperature of room where refrigerator is located:______ 4. Estimated amount of time the unit’s temperature was outside normal range: refrigerator _______ freezer ________ 5. Vaccines in the refrigerator/freezer during the event (use the table below)

* Using a recording thermometer is the most effective method of tracking the refrigerator and freezer temperatures over time. Visually checking thermometers twice a day is an effective method to identify inconsistent or fluctuating temperatures in a refrigerator and freezer.

Vaccines Stored in Refrigerator Vaccine, manufacturer, and lot #

Expiration date

m a

S

Vaccine, manufacturer, and lot #

Expiration date

# of doses

# of affected vials

Action taken

Vaccines Stored in Freezer

# of doses

# of affected vials

Action taken

Other Conditions 1. Prior to this event, was the vaccine exposed to temperatures outside the recommended range? Y N 2. Were water bottles in the refrigerator and ice packs in the freezer at the time of this event? Y N 3. Other: _____________________________________________________________________________ _____________________________________________________________________________ _____________________________________________________________________________

Manufacturers Crucell Vaccines Inc. CSL Biotherapies, Inc. GlaxoSmithKline MedImmune, Inc. Merck & Co., Inc. Novartis Vaccines Pfizer Inc. sanofi pasteur

(800) 533-5899 (888) 435-8633 (888) 825-5249 (877) 633-4411 (800) 672-6372 (800) 244-7668 (800) 438-1985 (800) 822-2463

Other Resources Local health department phone number ____________________________ State health department phone number _____________________________ Adapted by the Immunization Action Coalition, courtesy of the Michigan Department of Community Health Technical content reviewed by the Centers for Disease Control and Prevention, October 2010.

www.immunize.org/catg.d/p3051.pdf • Item #P3051 (10/10)

Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org

[Appendix D]

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.

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.

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.

Psychological fright and syncope (fainting)

m a

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.

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.

S

Anaphylaxis

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Fright before injection is given

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, April 2011.

www.immunize.org/catg.d/p3082.pdf • Item #P3082 (4/11)

Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org

[Appendix D] (page 2 of 2)

Medical Management of Vaccine Reactions in Adults (continued)

Supplies you may need at a community immunization clinic  First-line treatment: Aqueous epinephrine 1:1000 (i.e., 1 mg/mL) dilution, in ampules, vials of solution, or prefilled syringes, including epinephrine autoinjectors (e.g., EpiPen). If EpiPens are stocked, at least three 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 and 25g, 1”, 1½”, and 2” needles for epinephrine and diphenhydramine (Benadryl)

 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

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 Alcohol wipes  Tourniquet  Adult airways (small, medium, and large)  Adult size pocket mask with one-way valve  Oxygen (if available)  Stethoscope

Emergency medical protocol for management of anaphylactic reactions in adults

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 oncall 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 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 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. American Pharmacists Association, Grabenstein, JD, Pharmacy-Based Immunization Delivery, 2002.

These standing orders for the medical management of vaccine reactions in adult patients shall remain in effect for patients of the

Medical Director’s signature

name of clinic

until rescinded or until

date

.

Effective date www.immunize.org/catg.d/p3082.pdf • Item #P3082 (4/11)

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 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.

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 (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

S

Anaphylaxis

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 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)

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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.

 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)

 Secondary treatment option: Diphenhydramine (Benadryl) injectable (50 mg/mL solution) or oral (12.5 mg/5 mL liquid, 25 or 50 mg capsules/tablets)

 Pediatric & adult size pocket masks with one-way valve  Oxygen (if available)  Stethoscope

m a

 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

Emergency medical protocol for management of anaphylactic reactions in children and teens

S

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). 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)

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.

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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

m a

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

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

S

Secondary Treatment Option: Diphenyhydramine (the recommended dose for diphenhydramine [Benadryl] is 1–2 mg/kg body weight) Age Group

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

until rescinded or until name of clinic

Medical Director’s signature

date

.

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]

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: ____________________________________________________________________ We believe we should not be held responsible for the vaccine and request reconsideration 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)

VFC Vaccine Borrowing Report

Patient Name/Patient Identifier/ Insurance status (VFC or private) DOB

Date Borrowed 1. Private stock order delayed 3. VFC order delayed 5. other (specify) 1. Private stock order delayed 3. VFC order delayed 5. other (specify) 1. Private stock order delayed 3. VFC order delayed 5. other (specify) 1. Private stock order delayed 3. VFC order delayed 5. other (specify) 1. Private stock order delayed 3. VFC order delayed 5. other (specify)

2. Private stock non-viable on arrival 4. VFC order non-viable on arrival

2. Private stock non-viable on arrival 4. VFC order non-viable on arrival

2. Private stock non-viable on arrival 4.VFC order non-viable on arrival

2. Private stock non-viable on arrival 4. VFC order non-viable on arrival

2. Private stock non-viable on arrival 4. VFC order non-viable on arrival

Reason no appropriate stock vaccine was available (circle one)

Date vaccine returned to appropriate stock

Provider Signature:

Date: __________________

VFC Operations Guide

M-3 Provider Recruitment and Enrollment 18

This document can be found on the CDC website at: http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/07-module-3.pdf

Provider Name:

"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.”

Vaccine Borrowed

Directions for use of this form: When a provider has borrowed vaccine from one stock to administer to a child who is only eligible to receive vaccine from the other stock, this form must be COMPLETELY FILLED OUT for each borrowing occurrence. Each vaccine a child receives must be listed on a separate row. As soon as the borrowed doses of vaccine are replaced to the appropriate vaccine stock that date must be entered on this form. These borrowing reports must be kept as part of the VFC program records and be made available to the VFC staff during the VFC Site Visit.

Guidance: VFC-enrolled providers are expected to maintain an adequate inventory of vaccine for both their VFC and non-VFC-eligible patients. VFC vaccine cannot be used as a replacement system for a provider’s privately purchased vaccine inventory. The provider must assure that borrowing VFC vaccine will not prevent a VFCeligible child from receiving a needed vaccination because VFC vaccine was administered to a non-VFC eligible child. Borrowing would occur only when there is lack of appropriate stock vaccine due to unexpected circumstances such as a delayed vaccine shipment, vaccine spoiled in-transit to provider, or new staff that calculated ordering time incorrectly. The reason cannot be provider planned borrowing from either the private stock or the VFC stock.

Publication Date: August 2007 Revision Date: February 1, 2011

[Appendix G]

[Appendix H]

MnVFC Vaccine Management 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  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.

Immunization Program P.O. Box 64975 St. Paul, MN 55164-0975 651-201-5522, 1-800-657-3970 www.health.state.mn.us/vfc

(09/11)

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

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