s ] v ( } Z ] o v ~s& } u o ] v v s ] v ^ } P , v o ] v P ... · Title: Microsoft PowerPoint - Storage Handling_VFC 2020 webinar_pej reviewed_12.4.2019 Author: rbip Created Date:

Vaccines for Children (VFC) Compliance and Vaccine Storage & Handling

Training, Webinar 2020

Rattana Bip, Vaccines for Children Coordinator

Massachusetts Department of Public Health | Immunization DivisionVaccine Management UnitEmail: [email protected]: 617-983-6828 | F: 617-983-6924

Presenter Disclosure• I, Rattana Bip, have been asked to disclose any

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

2020 Enduring Webinar: Storage & Handling_VFC Compliance Training

Agenda• Overview of the Vaccines for Children Program• Vaccine Availability• Guidelines for Compliance

▫ Appropriate use of State-Supplied Vaccine▫ Vaccine Management▫ Billing and Charging for State-Supplied Vaccines▫ Vaccine Information Statements (VIS) and Consent


Vaccines for Children (VFC) ProgramThe Vaccines for Children (VFC) program was established by Congress in 1994 to increase access to vaccination for children who might not get vaccinated due to financial barriers.


VFC EligibilityThe VFC program serves children through 18 years of age who meet at least one of the following criteria

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


State-Supplied Vaccines AvailabilityMassachusetts universally supplies all routinely recommended pediatric vaccines to any child through 18 years of age regardless of insurance status. Those children not covered by the federal VFC Program are covered by a state trust fund. • Massachusetts also supplies no cost vaccines to

uninsured adults seen at public provider sites (CHCs, BOHs).

• All state-supplied vaccines can be used only according to the Childhood and Adult Vaccine Availability Tables.


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/resource/vaccine-management.


APPROPRIATE USE OF STATE-SUPPLIED VACCINE


Vaccine Availability TablesProviders must use state-supplied vaccines only for children and adults determined eligible as defined in the most recent versions of the ‘Childhood Vaccine Availability Table’ and the ‘Adult Vaccine Availability Table’. The vaccine availability table can be found here: https://www.mass.gov/resource/vaccine-management


VFC Screening• Providers must screen all children (birth through 18 years of

age) at every immunization visit.• Patient eligibility screening for VFC may be recorded

electronically if all information requested in the VFC Patient Eligibility Screening Form is both recorded and retrievable in the event of a VFC site visit.

• VFC screening information must be retained in the electronic medical record or on file in the office for a minimum of 3 years after service to the patient has been completed.


Borrowing VaccinesBorrowing vaccine is defined as the use of a dose of state-supplied vaccine for a child not eligible for state-supplied vaccine when privately purchased vaccine is not readily available or vice versa. • Borrowing vaccine should be extremely rare and only occur to

avoid a missed opportunity to provide a needed vaccine for a child who might otherwise not receive vaccine.

• 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 fax to the Vaccine Management Unit.▫ Borrowing reports must be kept on file and available for review during a

site visit.


Fraud and AbuseImproper 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.


Example of Fraud and AbuseFraud and abuse can include (but is not limited to):• Selling or misdirecting state-supplied vaccine.• Billing a patient or third party for state-supplied

vaccine.• Charging more than the administration fee for state-

supplied vaccine.• Failing to account for state-supplied vaccine.• Failing to receive, store, or use vaccine.


RestitutionMDPH will require providers to make restitution for 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


VACCINE MANAGEMENT


Standard Operating Procedures (SOP)Providers must have a written SOP in place for proper vaccine management.

• The SOP must be reviewed and updated annually or when there is a change in responsible staff.

• SOP should include procedures for▫ Proper storage and handling▫ Vaccine ordering, inventory control and receiving▫ Vaccine relocation in the event of power or equipment failure▫ Handling damaged or expired vaccines▫ Response and documentation to temperature excursions

All staff who are responsible for vaccines in any way must acknowledge reading their practice’s SOP by signing and dating the document.


Recommended Storage TemperaturesThe cold chain must not be broken, vaccines must remain at

proper temperatures between:Manufacturer Distributor Office/Clinic Patient

If temperature is colder than:2°C (35°F) for >15 Minutes

If temperature is warmer than:8°C (46°F) for > 30 Minutes

If temperature is warmer than:-15°C (+5°F) for >60 Minutes

FREEZERREFRIGERATOR

ImmediatelyUpload temp logs into MIIS and call the Vaccine Unit at 617-983-6828 if

temperatures are out of range.


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 Division recommends that MMR is stored in a freezer.

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


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.• Frequent opening may cause

temperature fluctuations.• Assure doors are always closed and

sealed.2020 Enduring Webinar: Storage & Handling_VFC Compliance Training

Digital Data Logger• All storage units that contain state-supplied pediatric vaccines are required to

have a digital data logger monitoring temperatures. • Digital Data Loggers must meet the most up to date standards set by the CDC.

The complete list of the standards are listed on the ‘Guideline for Compliance’. Below are a few examples: ▫ NIST certified calibration▫ Detachable probe with buffer solution▫ Alarm for out-of-range temperatures▫ Digital display that shows current, minimum, and maximum temperatures.▫ The ability for the provider to acknowledge min/max temperature daily.▫ Is able to generate a PDF report that can be uploaded into the MIIS

Report must be easily identify alarms, duration of alarms, and minimum and maximum temperatures.


Data Logger Report• Data logger reports must be uploaded directly into the

MIIS with every vaccine order or MONTHLY.• Urgent temperature issue must be uploaded directly into

the MIIS. • Faxing temperature logs for orders or an urgent issue

could cause a delay in response. • Additionally, uploading reports directly into the MIIS

satisfies the requirement to keep logs for three years.


Monitoring Temperatures• All providers must review the minimum, maximum and current

temperature daily. ▫ By doing this, it 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 outside of the

recommended ranges, then they must take action by following the SOP.• NEVER adjust a storage unit temperature controls with vaccine in the

unit.▫ Always contact the Vaccine Management Unit when moving vaccines.

• Contact the Vaccine Management Unit with any questions.



Expired/Damaged Vaccine• Report expired or damaged vaccine through the

‘Storage/Handling Issues’ 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.


Reporting Expired/Damaged Vaccine• Vaccine can be reported either in the beginning of a new order or as a

separate storage and handling issue.


Examples of Storage/Handling Issues


Transferring Vaccines• Providers should aim to have no

expired vaccine.• Vaccines that are expiring soon

will be highlighted orange and vaccines that are expired will be highlighted red in the MIIS.

• If a provider cannot use vaccine prior to expiration, the vaccine should be transferred to another enrolled provider.

• Transfers must be processed via the MIIS.


Transporting Vaccine1

• Contact back up storage location to make sure they can accommodate your vaccines.

2• Obtain hard sided or Styrofoam cooler and label outside of cooler “Must Store in Fridge” or “Must Store in Freezer”

3• 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

4• Retrieve your Data Logger and place the glycol vial into the cooler. Keep Data Logger display outside of cooler.

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

6• 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.*

7• Contact the MDPH Vaccine Unit at (617)983-6828 with transport information.


Vaccine Ordering • Select ‘Order’ in MIIS.• Create a new order.• Process any expired or damaged vaccines• Print Vaccine Inventory Worksheet.

• Reconcile Inventory.• Request vaccines and add notes to vaccine unit if necessary.• Upload temp logs for all storage units.• Confirm Shipping address and hours.• Submit.


Recommended RequestThe ‘recommended request’ is a recommendation of the number of doses that a site should order to maintain a 2 to 2.5 month inventory.


Vaccine Arrival

Alert office staff to expect

vaccine shipment

within 2 weeks after vaccine

order 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

order – if there is a problem,

call the Vaccine Unit

immediately.

Place vaccines in appropriate storage units.

Maintain packing lists for at least 3

years.


Responsibilities of Provider• Medical Director

▫ Responsible for ensuring that state-supplied vaccine is administered in compliance with federal requirements for administration of vaccine.

▫ Ensuring that annual enrollment is completed in order to receive vaccines. ▫ Understands and agrees that MDPH Immunization Division staff are required to make site

visits.▫ Responsible for designating a Primary and Back-up Vaccine coordinator.

• 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 Primary or Back-up Vaccine Coordinator must be reported within 10 days.


Annual Enrollment• Completed in the MIIS.• Complete the following fields:

▫ Practice Profile▫ Shipping address and hours of operation ▫ Update all providers on the Provider List Tab and select the Provider Type

for all providers listed (Adult, Pediatric, or Pediatric/Adult)• Confirm required fields are still accurate:

▫ Primary and Back-up Vaccine Coordinator and title (ex: MA, CMA, RN etc.)▫ Medical Director names and e-mail address

• Ensure that at least the Primary and Back-up Vaccine Coordinator at your practice has received a VFC Compliance and Storage and Handling training and received a certificate during the previous year.


Site Visit• MDPH Immunization Division conducts site visits for practices every 2 years.• Sites are assessed for compliance with VFC and other federal requirements in

accordance with MDPH guidelines.• If any problems are identified with VFC compliance, the site is entered into 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 of the organization).

• MDPH is required to complete a certain number of unannounced visits each year.


Documentation• Records related to the immunization division should be kept for at least

three years. ▫ Patient eligibility▫ Temperature logs (maintained in MIIS) and Vaccine packing slips▫ Borrowing Report▫ Temperature Troubleshooting Logs

• Providers must ensure that the permanent medical record of the recipient contains all the required documentation for immunizations.▫ Requirements for retention of written documentation vary and depend on

licensing requirements.


Billing and Charging for State-supplied Vaccines


Billing and Charging for State Supplied Vaccine

• The vaccine administration fee is up to $23.29 per 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.


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.


Vaccine Information Statements (VIS) and Consent


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.


Vaccine Information Statements (VIS)All providers must maintain copies of the most up to date VISs in their office.

www.cdc.gov/vaccines/hcp/vis/2020 Enduring Webinar: Storage & Handling_VFC Compliance Training

Vaccine SafetyAdverse events should be reported via the Vaccine Adverse Events Reporting System (VAERS).• Providers can report directly to VAERS by going to the VAERS

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


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.


Please Call With Any Questions• The Vaccine Management Unit can be reached at

617-983-6828 with any issue relating to vaccine availability, storage, or handling.

• The MIIS Help Desk can be reached at 617-983-4335 with any questions regarding the immunization registry.


To all of the Medical Directors, Primary and Back-up Vaccine Coordinators, RNs, MAs, other office staff involved with

immunizations at provider offices,Thank you for all you do to take care of vaccines and, in turn,

take care of your patients and protect them from vaccine preventable diseases!


Documents

s ] v ( } Z ] o v ~s& } u o ] v v s ] v ^ } P , v o ] v P ... · Title: Microsoft PowerPoint - Storage Handling_VFC 2020 webinar_pej reviewed_12.4.2019 Author: rbip Created Date: