and VFC Compliance MDPH Immunization Division Vaccine Management - - PDF document

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Vaccine Storage & Handling and VFC Compliance

MDPH Immunization Division Vaccine Management Unit

Shumethia Seal, MPH Vaccine Manager

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Presenter Disclosure

• I, Shumethia Seal, have been asked to disclose any

significant relationships with commercial entities that are either providing financial support for this program

• r whose products or services are mentioned during

my presentations.

• I have no relationships to disclose.
• I may discuss the use of vaccines in a manner not

approved by the U.S. Food and Drug Administration but in accordance with ACIP recommendations.

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2019 Year in Review

January Annual Enrollment July Change Allocation for Flu February Flu Pre-book August Flu Vaccine is available March September April Adult Conference October MIAP May Immunization Updates November June December

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Annual Enrollment

• Completed in the MIIS.
• Confirm all information is accurate.
• Ensure that at least the Primary and Backup

Vaccine Coordinator at your practice has received a VFC Compliance and Storage and Handling training and received a certificate during the previous year.

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Site Visit

• Occurs every two years.
• Assessed for compliance with VFC and other federal

requirements in accordance with MDPH guidelines.

• Issues result in sites entering an educational follow-

up process in accordance with CDC guidelines.

• At the end of the visit, providers will receive a

Provider Follow-up Plan and it must be signed by the Medical Director (or staff authorized to sign on behalf

• f the organization).

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Unannounced Site Visit

• Focused on Storage and

Handling

• MDPH is required to do a

specific amount of visits

In-Person Training

• Focused on giving an overview of

the program

• Prompted by a new Vaccine

Coordinator at the site

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Quiz

Providers must be assessed for compliance with VFC and other federal requirements in accordance with MDPH guidelines every other year. What is one of the most frequent findings at provide site visits?

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Resources

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Guidelines for Compliance

Vaccine management and VFC requirements and recommendations are detailed in the ‘Guidelines for Compliance with Federal and State Vaccine Administration Requirements’. https://www.mass.gov/service- details/vaccine-management

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Standard Operating Procedures (SOP)

Providers must have a written SOP in place for proper vaccine management.

• SOP should cover both routine and emergency procedures.
• All staff who are responsible for vaccines in any way must

acknowledge reading their practice’s SOP by signing and dating the document.

– annually – as part of employee orientation – change in responsible staff (Vaccine Coordinators)

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Vaccine Information Statements (VIS)

• All providers are required to provide a copy of the relevant, current

edition of the VIS produced by the CDC before administering a doses of vaccine (NCVIA: 42 U.S.C. Section 300aa-26).

• Copies of the most recent VIS can be

found at www.immunize.org/vis or on the CDC website at www.cdc.gov/vaccines/hcp/vis/.

• Sign up to receive emails when VISs are

updated at www.cdc.gov/vaccines/hcp/vis.

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Vaccine Safety

Adverse events should be reported directly to the Vaccine Adverse Events Reporting System (VAERS) through the website or calling.

https://vaers.hhs.gov/ or 800-822-7967

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Using State-Supplied Vaccine

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Vaccine Availability

Massachusetts supplies vaccines to any child under 19 through state funding for privately insured children and through the federally funded Vaccines for Children (VFC) program to publicly insured children or other children who meet VFC eligibility. All of these vaccines are considered state supplied and can be used according to the Childhood and Adult Vaccine Availability Tables.

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VFC Eligibility

Birth through 18 years of age:

• Enrolled in Medicaid
• Uninsured
• Under-insured and seen at an FQHC
• American Indian (Native American) or Alaska Native

Providers must screen and document VFC eligibility for all children at every immunization visit.

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Billing and Charging for State Supplied Vaccine

• The vaccine administration fee is up to

$23.29/dose for non-Medicaid VFC-eligible patients.

• Providers may not bill for the cost of any state-

supplied vaccines.

• Providers may not deny state-supplied vaccine to

an established patient due to the inability to pay the administration fee.

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Clarification of billing practices in the VFC Program

Starting January 1, 2020, providers who bill vaccine administration fees to non-Medicaid VFC-eligible children after the date of service may issue only a single bill to the patient within 90 days of vaccine administration. Patients cannot be turned away or reported to collections for the inability to pay the vaccine administration fee.

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Borrowing Vaccines

Borrowing is the use of state-supplied vaccine for a child not eligible for state-supplied vaccine when privately purchased vaccine is not readily available or vice versa.

• State-supplied vaccine may never be borrowed for

use in someone 19 years of age or older.

• If a provider borrows state-supplied vaccine, a

Vaccine Borrowing Report Form must be completed and sent to the Vaccine Unit.

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Documentation

• Records related to the immunization program

should be kept for at least three years.

• Ex. Patient eligibility, vaccine packing slips,

borrowing reports, etc.

• Providers must ensure that the permanent

medical record of the recipient contains all the required documentation for immunizations.

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Quiz

MA is universal for all routinely recommended pediatric vaccines except?

a) Tdap b) Men B c) HPV4 d) Menactra

A doctor is requiring a 21 year old to be revaccinated due to a specific medical reason, is this patient eligible for State-Supplied Vaccines? Yes or No

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Responsibilities of Provider

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Medical Director

• Responsible for ensuring that state-supplied vaccine

is administered in compliance with federal requirements.

• Ensuring that annual enrollment is completed to

receive vaccines.

• Understands and agrees that MDPH Immunization

Division staff are required to make site visits.

• Responsible for designating Primary and Backup

Vaccine Coordinators.

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Primary and Back-Up Vaccine Coordinator

• Responsible for all oversight of all vaccine storage

and handling including vaccine ordering and acting as the vaccine shipping contact.

• Responsible for communicating vaccine policy,

vaccine availability, updates and alerts to staff. Any changes in the Vaccine Coordinators must be reported within 10 days.

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Fraud and Abuse

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Improper use of state-supplied vaccine may constitute fraud and abuse.

• Fraud – intentional deception made by a person with

the knowledge that it could result in some unauthorized benefit to themselves or some other person.

• Abuse – provider practices that are inconsistent with

sound fiscal, business, or medical practices, and result in unnecessary cost to the Medicaid program, Immunization Division, Health Insurance Company, or patient.

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Restitution

MDPH requires providers to replace any doses of state- supplied vaccines that have been lost due to the provider’s failure to properly receive, store, or use vaccines if:

– 1st incident and the total loss is over $10,000 – 2nd incident (or greater) regardless of total value – Due to a failure to immediately open a vaccine shipment from McKesson or Merck resulting in damaged vaccine regardless of total value – Due to a failure to store refrigerated vaccine in a refrigerator or failure to store frozen vaccine in a freezer

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Quiz

Sites are encourage to transfer vaccine to prevent wastage, this is also considered borrowing. My state-supplied flu vaccine hasn’t arrived, but I have a flu clinic scheduled next week. I should just use my private vaccine so there aren’t any missed

• pportunities?

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Vaccine Management

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Storage Units

• All refrigerator storage units are required to be pharmaceutical grade

– Purpose-built units can also be used to store state supplied vaccine. They are designed specifically for the storage of vaccines.

• Frozen vaccine must be stored in stand-alone freezers

– Stand-alone freezers can be very small, the size of a microwave in some cases. – MDPH Immunization program recommends that MMR is stored in a freezer.

If the immunization program identifies that your storage unit does not meet these requirements, your ability to order will be limited.

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Recommended Vaccine Storage Temperatures

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REFRIGERATOR FREEZER Celsius Range 2°C to 8°C

• 50°C to -15°C

Fahrenheit Range 35°F to 46°F

• 58°F to 5°F

DDL Alarm Limits Unit is > 8°C for 30 consecutive minutes. Unit is > -15°C for 60 consecutive minutes. Unit is < 2°C for 15 consecutive minutes.

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Vaccine Storage Tips

• Keep vaccines in original manufacturer

packaging.

• Organize vaccines by type and expiration

date.

• Storage units must be plugged directly

into a wall outlet.

• Avoid over-filling refrigerator and

hindering air circulation.

• Assure doors are always closed and

sealed.

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Digital Data Logger

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Recommended Features of a DDL

– Detachable buffered probe – Alarm – Low battery indicator – Min/max display – Adjustable reading rate – Report can be uploaded as a .pdf and should easily identify daily minimum and maximum temperatures and duration of alarm.

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Recertification of DDLs not supplied by State

In 2020, the Vaccine Management Unit will begin re-evaluating non-state-supplied data loggers to ensure they meet the most-up-to date standards set by the CDC.

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Uploading Data Logger Report

• The data logger will show

up as FT-2 L.

• There are two files stored
• n the data logger:
• .txt file
• .pdf file (the file that is

uploaded into MIIS)

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Data logger reports should be uploaded directly into the MIIS.

• Faxing temperature logs could cause a delay in response.
• Uploading reports directly into the MIIS satisfies the requirement to keep

logs for three years.

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Monitoring Temperatures

• Providers should read the minimum and maximum

temperatures twice a day.

– This will help identify temperature trends and problems with a storage unit before vaccine loss occurs.

• If anyone at the site notices that the refrigerator is running
• utside of the recommended ranges, then they should take

action.

NEVER adjust a storage unit temperature controls with vaccine in the unit.

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Temperature Excursion

Notify

• Contact Vaccine

Unit

• Let staff know

that vaccines cannot be administered until stability is confirmed

Document

• Keep track in

Troubleshooting Log

Contact

• Vaccine Unit will

contact manufacturers to confirm stability

• VU will contact

site with stability information.

Correct

• Determine how

to prevent repeat events

• Is the door

closing properly?

• Is unit
• verstocked?

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Expired/Damaged Vaccine

• Report expired or damaged vaccine through the

“Storage/Handling Problem” function in the MIIS.

–Immediately remove from the refrigerator/freezer. –Label “Do Not Use.” –Package for return to McKesson.

• Open/contaminated vaccine does not need to be

returned, but still needs to be reported in the MIIS.

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Reporting Expired/Damaged Vaccine

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Vaccine can be reported either in the beginning of a new order

• r as a separate storage and handling issue.

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Reporting Storage/Handling Problem

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Quiz

• True or False, you must upload your temperatures logs

monthly, even if you do not order monthly, so as not to lose data.

• True or False, uploading temperature logs into the MIIS meets

the VFC requirement for maintaining temperature logs for at least 3 years.

• Why should you “READ” the data logger?

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Quiz

• True or False, you must upload your temperatures logs monthly, even if

you do not order monthly, so as not to lose data.

• True or False, uploading temperature logs into the MIIS meets the VFC

requirement for maintaining temperature logs for at least 3 years.

• Why should you “READ” the data logger?

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Sites are required to acknowledge min/max temperatures twice

• daily. Min/max temperatures can be used to identify trends and

ensures that alarms will be identified.

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Transferring Expiring Vaccines

• Providers should aim to have no expired vaccine.
• Vaccines that are expiring soon or expired will be

highlighted in the MIIS.

• If a provider cannot use vaccine prior to

expiration, the vaccine should be transferred to another enrolled provider to avoid wastage.

• Transfers must be processed via the MIIS.

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Transporting Vaccine

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Contact backup storage location to make sure they can accommodate your vaccines.

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Obtain hard sided or Styrofoam cooler and label

• utside of cooler “Must Store in Fridge” or

“Must Store in Freezer”

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Place COLD packs in the bottom of cooler. Place bubble wrap or cardboard on top of the cold

• packs. DO NOT USE ICE PACKS for Refrigerated

Vaccine

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Retrieve your Data Logger and place the glycol vial into the cooler. Keep Data Logger display

• utside of cooler.

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Place vaccine boxes on top of bubble wrap/cardboard. Cover vaccines with another layer of bubble wrap/cardboard.

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Document the time and temperature of vaccine when placed in transporting container. Also document the time and temperature of vaccine when placed in back up unit.*

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Contact the MDPH Vaccine Unit at 617- 983-6828 with transport information.

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Vaccine Order Process

1. Select ‘Orders’ in MIIS. 2. Create a new order. 3. Process any expired or damaged vaccines. 4. Print Vaccine Inventory Worksheet. 5. Reconcile Inventory. 6. Request vaccines and add notes to vaccine unit if necessary. 7. Upload temp logs for all storage units. 8. Confirm Shipping address and hours. 9. Submit.

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Vaccine Arrival

Alert office staff to expect vaccine shipment within 2 weeks after vaccine

• rder is

approved.

When shipment arrives, open the box immediately.

Check the temperature monitors – if there is a problem, call Vaccine Unit immediately.

Verify packing list matches your vaccine

• rder – if there

is a problem, call the Vaccine Unit immediately.

Place vaccines in appropriate storage units. Maintain packing lists for at least 3 years.

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Vaccine Management Monthly Updates

• The Vaccine Management Unit sends out monthly

updates that include information about vaccine supply, upcoming dates, and other important information.

• Please ensure that you are reading these updates.

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Please Call With Any Questions

• The Vaccine Management Unit can be

reached at 617-983-6828 with any issue relating to vaccine availability, storage,

• r handling.
• The MIIS Help Desk can be reached at

617-983-4335 with any questions regarding the immunization registry.

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