How to Be Accountable in the MnVFC Program

Assign a vaccine coordinator and backup vaccine coordinator

• Assign staff to the roles of vaccine coordinator and backup vaccine coordinator. Train them on the required activities listed below. Vaccine coordinator is responsible for all activities and can assign some activities to the backup vaccine coordinator (or other designee).
• Vaccine coordinator is the primary MnVFC/UUAV contact at each site. All sites are required to have a vaccine coordinator on-site. This person is ultimately responsible for the management of vaccine and ensuring their site complies with MnVFC program requirements. They receive MIIC vaccine order confirmation emails for MnVFC orders.
• Backup vaccine coordinator is the secondary MnVFC contact at each site. All sites are required to have a fully trained backup vaccine coordinator who is responsible when the primary vaccine coordinator is unavailable. They receive MIIC vaccine order confirmation emails for MnVFC orders.
• Notify us of all vaccine coordinator and backup vaccine coordinator changes by completing the MnVFC Contact Update Form.

Vaccine coordinator and backup vaccine coordinator responsibilities

The vaccine coordinator is responsible for overseeing all vaccine management within the facility, (or backup vaccine coordinator if the vaccine coordinator is unavailable) including:

• Develop and maintain the Vaccine Management Plan.
• Monitor storage and handling and vaccine administration practices in the facility.
• Oversee vaccine ordering and transfer vaccine that is nearing expiration to another MnVFCenrolled site to avoid wastage.
• Replacement method sites must run monthly vaccine reports and track data to inform MnVFC vaccine ordering.
• Ensure and document annual management training for designated staff, as well as train new staff upon hire.
• Participate in and document completion of annual training on VFC requirements.
• Store all required documentation for three years, or longer if required by state statutes or rules, even in the case of provider retirement or provider location closure.
• To effectively perform their duties, the vaccine coordinator and backup vaccine coordinator must be fully trained on routine and emergency standard operating procedures (SOPs) for vaccine ordering, storage, handling, transport, and inventory management. Communicate with the MnVFC program. These people will receive regular communications from the MnVFC program by mail, phone, and email. They will need to share some of it with other staff.
  • Complete the annual online training on MnVFC Required Annual Reports and Trainings.
  • Sign up to receive MnVFC Announcements via email.
  • Sign up for Got Your Shots? News and the Immunize.org IZ Express.
• Train other staff that have vaccine-related responsibilities (for example, the front desk staff who receives immunization shipments and providers giving immunizations) as well as new staff upon hire and keep a log to document attendance.
• Develop policies and procedures related to vaccine management. This manual can fulfill this requirement if your staff read the entire manual, sign the Signature Page, and complete the emergency plan and attach an anaphylaxis protocol to the manual (review Introduction to the MnVFC Policies and Procedures Manual for more information).
• Download and review temperature data weekly.
• Make sure all ACIP-recommended vaccines for your patient population are ordered, received, stored, and handled properly.
• Be aware of where vaccines are stored in all site clinics and be responsible for making sure they are meeting the requirements.
• Designate on-site staff to document the min/max temperature in each storage unit at the start of each day the site is open.
• Respond to temperature excursions (out-of-range temperatures).
• Conduct inventory of vaccines at least monthly and with each order.
• Check expiration dates and rotate stock weekly.
• 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.

MnVFC compliance site visits

• You will participate in a site visit by an MDH or local public health staff person, called a MnVFC site reviewer, every one to two years.
• You will need to have three months of temperature documentation data available at site visits for each vaccine storage unit for the site reviewer to review.
• Site visits take approximately two hours.
• They will offer you support and guidance and ensure you are meeting the federal and state MnVFC requirements.
• The MnVFC site reviewer will:
  • Contact you in advance of each visit.
  • Encourage you to invite other staff members who could contribute to the visit.
  • Share resource materials during the visit.
  • Provide you with a site visit summary.
• If your site is not meeting a specific program requirement, they will work with you to develop a corrective action plan that you will need to follow within a specified time frame, usually 30 days.
• You may also call on MnVFC site reviewers for in-service training, guidance in developing policies and procedures and troubleshooting vaccine-related concerns.

Unscheduled site visits

• The MnVFC program is required by CDC to perform unscheduled storage and handling visits to serve as “spot checks” for proper storage and handling practices.
• These visits ensure all MnVFC-eligible children are receiving properly managed, viable vaccines and provide education about requirements and best practices related to storage and handling.
• As part of your signed MnVFC Provider Agreement, your participation in unscheduled visits is required. We appreciate your cooperation when we arrive at your site unannounced.

Maintain your enrollment in MnVFC

Each site that stores and/or administers MnVFC vaccine must enroll in the MnVFC program and have their own personal identification number (PIN). Sites are responsible for maintaining their enrollment in the program by completing the requirements below.

Every 24 months requirement

Submit the MnVFC Program Provider Agreement

• All sites need to complete and have their medical director sign a MnVFC Program Provider Agreement every 24 months in odd years.
• A link to complete the MnVFC Program Provider Agreement will be emailed. More information is available on MnVFC Required Annual Reports and Trainings.

Every 12 months requirements

Submit the MnVFC Annual Report of Immunized Pediatric Patients

• Complete and submit the Minnesota Vaccines for Children (MnVFC) Program Annual Report of the Number of Immunized Pediatric Patients by Nov. 30. This report is an unduplicated count of all patients 0 through 18 years of age that received an immunization between Oct. 1 and Sept. 30.
• If you redistribute to satellite sites, submit one annual report that includes data from those sites.
• A link to complete the MnVFC Annual Report of Immunized Pediatric Patients will be emailed to your system-level contact (if you have one), or it will be emailed to your vaccine coordinator when it becomes available. More information is available on MnVFC Required Annual Reports and Trainings.
• Sites that track immunizations with dose-level eligibility (DLE) information in MIIC can use the Request MnVFC Reports in MIIC to produce data for this report. For more information, see the MnVFC Reports in MIIC user guidance on Vaccine Ordering and Management in MIIC.
• Ordering privileges may be suspended if the MnVFC Annual Report of Immunized Pediatric Patients is not submitted by Nov. 30.

Complete the MnVFC online training

• Your site’s vaccine coordinator and backup vaccine coordinator must complete the MnVFC online training each year by Nov. 30 to meet the federal VFC education requirement.
• The MnVFC online training is available on MnVFC Required Annual Reports and Trainings.
• After completing the training, print the completion certificate and keep it with your MnVFC documents for three years. You will be asked to show your certificate during your MnVFC site visit.

Potential fraud and abuse

• Fraud is an intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to himself or some other person.
• Abuse is provider practices that are inconsistent with sound fiscal, business, or medical practices. It results in an unnecessary cost to the Medicaid program or in reimbursement for services that are not medically necessary or that fail to meet professionally recognized standards for healthcare.
• Report fraud or abuse to the MnVFC program by calling 651-201-5522 or emailing health.mnvfc@state.mn.us.
• All instances of possible fraud or abuse will be investigated on a case-by-case basis.
• If you have not met MnVFC requirements or followed MnVFC procedures as outlined in this manual, but the MnVFC program finds no intentional deception, misrepresentation, or negligence on your part, you may be required to participate in training and/or to take other actions to rectify the situation.
• If the MnVFC program finds evidence of intentional deception, misrepresentation, or negligence on your part, the situation will be further investigated for potential enforcement of relevant laws including fraud and abuse, consumer protection, and professional licensure.
• Examples of potential fraud and/or abuse:
  • Providing MnVFC vaccine to non-eligible patients.
  • Selling or otherwise misdirecting MnVFC vaccine.
  • Billing a patient or third party for MnVFC vaccine.
  • Charging more than the maximum allowable fee for administration of a MnVFC vaccine.
  • Not providing MnVFC vaccine to an eligible patient because they are unable to pay the administration fee.
  • Failing to screen and document patients for MnVFC eligibility at every visit.
  • Failing to maintain MnVFC records for a minimum of three years.
  • Failing to fully account for MnVFC vaccine.
  • Failing to properly store and handle MnVFC vaccine, including not responding appropriately to temperature excursions.
  • Wasting MnVFC vaccine.
  • Over ordering MnVFC vaccine.
  • Failing to comply with any part of the provider agreement.
• Replacement method sites:
  • Not tracking private vaccine doses administered to MnVFC-eligible children.
  • Not ordering MnVFC vaccine doses to replace private doses administered.
  • Replacement method sites: Failing to comply with any part of the replacement agreement.

Replace wasted MnVFC vaccine

• The MnVFC program will review all instances of spoiled or expired MnVFC vaccine on a case-bycase basis. This review will help determine whether negligence was involved. Negligent waste of vaccine may be considered fraud or abuse of the MnVFC program.
• 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 on a dose-for-dose basis with privately purchased vaccine.
• You must replace vaccine upon receipt of the letter. The MnVFC program will stop supplying you with vaccine until all of the nonviable vaccine is replaced.
• Providers must submit receipt of purchase of vaccine to the MnVFC program within 90 days demonstrating that all doses were replaced appropriately.
• You may file an appeal with the MnVFC program by mail if you believe you can offer proof that the waste of vaccine was not due to negligence.
  • Use the Vaccine Restitution Appeal Form on Vaccine Management Forms, 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.
  • Drawing up vaccine before screening patients.
  • Not receiving or storing vaccine properly.
  • Leaving a refrigerator or freezer unplugged or an electrical breaker switched off.
  • Leaving a refrigerator or freezer door open or ajar.
  • Not repairing or replacing a broken refrigerator/freezer immediately.
• Examples of situations that do not require restitution because they are out of your control:
  • A shipment is not delivered to you on time or is damaged in transit.
  • You are unable to take action during a power outage.
  • A vial is accidentally dropped or broken.
  • Vaccine drawn after screening for contraindications and parental education but not administered due to parental refusal or a change in the physician orders.