2016 Vaccines for Children (VFC)

Annual Provider Training

Glora A. Crouch, BSRT R AFIX Coordinator/VFC Program Specialist

October 3-13, 2016 Wheeling, Clarksburg, Elkins, Beckley, Nitro, Parkersburg and

Martinsburg

Centers for Disease Control and Prevention (CDC) Requirement

• All key staff (i.e., Vaccine Coordinator and Back-up Coordinator) must undergo annual training on Vaccines for Children (VFC) Program requirements

• Training must be documented • Although it is required for key staff, CDC also recommends annual training for all staff involved in assessing VFC eligibility and handling and/or administering VFC vaccines

*The information provided in the following slides is from the CDC 2015 VFC Compliance Site Visit Reviewer Guide

PURPOSE

1

AGENDA

• Vaccine Administration Fee

• Required Documentation

• VFC Eligibility Screening

• Vaccine Storage & Handling

• Assessment Feedback Incentives eXchange (AFIX) Site Visit/West Virginia Statewide Immunization Information System (WVSIIS) Reporting

2

VACCINE ADMINISTRATION FEE The vaccine administration fee for non-Medicaid, VFC-eligible children must not exceed $19.85. VFC-eligible children must not be denied vaccine based on the patient’s inability to pay the vaccine administration fee.

3

REQUIRED DOCUMENTATION Providers must maintain immunization records in accordance with federal law. Records must contain ALL of the following elements:

1. Name of vaccine administered

2. Date vaccine was administered

3. Date Vaccine Information Statement (VIS) was given

4. Publication date of VIS

5. Name of vaccine manufacturer

6. Lot number

7. Name and title of person who administers the vaccine

8. Address of clinic where vaccine was administered 4

VFC Eligibility Categories

• 0 through 18 years of age • Medicaid-eligible: A child who is either Medicaid- eligible OR Medicaid-enrolled is eligible for VFC • Uninsured: A child who has no health insurance is eligible for VFC

VFC ELIGIBILITY SCREENING

5

VFC ELIGIBILITY SCREENING VFC Eligibility Categories

• Underinsured: A child whose health insurance does not cover vaccines or it only covers select vaccines is eligible NOTE: Underinsured children are eligible to receive vaccine only through a Federally Qualified Health Center (FQHC), Rural Health Center (RHC) or any West Virginia local health department (LHD)

• American Indian/Alaskan Native(AI/AN) is eligible for VFC 6

VFC ELIGIBILITY SCREENING

• Providers must properly document eligibility status (including eligibility category) at each immunization visit

• Providers must use screening results to ensure that only VFC-

eligible children receive VFC vaccine and proper billing practices associated with the VFC Program are followed

• Eligibility documentation must be maintained for a minimum of

three years from the date of the patient visit • Eligibility status must be readily available to staff administering

vaccine prior to selecting which vaccine stock to use

7

VACCINE STORAGE & HANDLING Proper Storage

Vaccines should be kept in their original packaging from the manufacturer and/or CDC centralized distributor and placed in the middle of the unit, with space both between the vaccines and the side/back of the unit.

X Vaccines should not be stored in the doors, vegetable bins, or floor of the unit or under or near cooling vents, and there should not be any food in the unit.

8

VACCINE STORAGE & HANDLING

CDC Recommends

Water bottles (for refrigerators) or frozen coolant packs (for freezers) should be placed throughout each storage unit in order to:

1. Stabilize or extend temperatures during a power outage 2. Serve as physical blocks preventing the placement of vaccines in areas of the unit that are at higher risk for temperature excursions

9

VACCINE STORAGE & HANDLING

Storage Units REQUIREMENT: X Dorm- and bar-style units are prohibited for vaccine storage RECOMMENDATIONS: • Pharmaceutical grade stand-alone or combination units

(preferred) • Household/commercial stand-alone units • Household/commercial combination units using the

refrigerator section only

10

VACCINE STORAGE & HANDLING

11

Dual-zone unit is acceptable for refrigerated vaccine storage only – do not use freezer compartment

Source: CDC VFC In-Action 2013 Storage and Handling Presentation

VACCINE STORAGE & HANDLING

12

• Vegetable bins are empty • Water bottles are placed in

the unit • Vaccines are kept in original

packaging, organized and not touching unit walls

Source: CDC VFC In-Action 2013 Storage and Handling Presentation

VACCINE STORAGE & HANDLING

13

• Storage unit is too full

• Vaccines are stored outside of original packaging

• Thermometer is against the wall

Source: CDC VFC In-Action 2013 Storage and Handling Presentation

VACCINE STORAGE & HANDLING Vaccine Management Plan

• VFC providers must develop, maintain and implement plans for

routine and emergency vaccine management • Plans must be reviewed and/or updated annually or more

frequently if changes occur • All information in the plan must be current • A “review date” and signature are required on all plans in order

to verify that they are current • Plan must be posted on/near the storage unit

14

VACCINE STORAGE & HANDLING Borrowing Reports

• VFC-enrolled providers are expected to maintain an adequate inventory of vaccine for VFC-eligible and non-VFC-eligible patients

• Borrowing of vaccine between private and public inventories must be a rare, unplanned occurrence

• VFC vaccine cannot be used as a replacement system for a provider’s privately purchased vaccine inventory

• All instances of borrowing must be properly documented, reported and replaced

15

VACCINE STORAGE & HANDLING

Additional Storage & Handling Requirements

• Separation of VFC and Private Vaccines: Clinics/practices that serve both VFC and non-VFC-eligible children must maintain separate vaccine inventories that allow them to clearly differentiate public stock from private stock.

• Separation of VFC and Children’s Health Insurance Program (CHIP) Vaccines: Clinics/practices that serve both VFC and non-VFC-eligible children must maintain separate vaccine inventories that allow them to differentiate VFC vaccines from CHIP vaccines. Use labels provided by the Division of Immunization Services.

• “Do Not Disconnect” Signs: Providers must take steps to protect the power source for all vaccine storage equipment by means of warning labels. This includes the circuit breaker box.

16

VACCINE STORAGE & HANDLING

Temperature Monitoring Equipment

Clinics/practices MUST have a working calibrated thermometer with a current and valid certificate of calibration testing issued either by an ILAC MRA-accredited laboratory or, if not ILAC MRA-accredited, the certificate must contain the measurement results and a statement indicating that it meets ISO 17025 standards.

17

VACCINE STORAGE & HANDLING Temperature Monitoring Equipment

All certificates of calibration testing must contain:

• Name of device (optional)

• Model number

• Serial number

• Date of calibration

• Measurement results indicate unit passed test and the documented uncertainty is within suitable limits (recommended uncertainty = +/-1º F (0.5º C)

18

VACCINE STORAGE & HANDLING

19 Source: CDC VFC In-Action 2013 Storage and Handling Presentation

VACCINE STORAGE & HANDLING

Digital Data Loggers • CDC recommends the use of a digital data logger thermometer

with a detachable probe in a buffered material with continuous monitoring and recording capabilities

• The temperature should be easily readable from the outside of

the unit

20

VACCINE STORAGE & HANDLING

Digital Data Loggers • Temperature probes should be buffered so that temperature

monitoring devices measure the temperature of vaccine vials – not the temperature of the air in a storage unit

• A buffered probe is a temperature probe immersed or inserted

in one of the following: A vial filled with liquid (e.g., glycol, ethanol, glycerin) A vial filled with loose media (e.g., sand, glass beads) A solid block of material (e.g., Teflon®, aluminum)

21

VACCINE STORAGE & HANDLING

Digital Data Loggers

• When selecting a data logger, CDC recommends the following features: Alarm for out-of-range temperatures Current, minimum and maximum temperatures Low battery indicator Accuracy of +/- 1º F (0.5º C) Memory stores at least 4,000 readings

22

VACCINE STORAGE & HANDLING

Proper Temperature/Excursions

• Vaccines must be stored under appropriate temperatures at all times

• Acceptable temperature ranges:

Refrigerated vaccines are 36º F and 46º F (2º C and 8º C)

Frozen vaccines between -58º F and +5º F (-50º C and -15º C)

23

VACCINE STORAGE AND HANDLING

Proper Temperature/Excursions

• In the event of a temperature excursion, provider must:

1. Quarantine and label vaccines as “Do Not Use”

2. Contact the state immunization program to report the excursion

3. Obtain documentation of manufacturer guidance that determined vaccine viability

24

VACCINE STORAGE & HANDLING

Temperature Logs

• Temperature documentation must contain: 1. At least two temperature readings per day 2. The time and date of each reading 3. The name (or initials) of the person who assessed and

recorded the readings • CDC also recommends that providers using a data logger to

record the minimum and maximum temperatures of each unit once each workday (preferably in the morning)

25

AFIX/WVSIIS REPORTING What is AFIX?

Assessment Feedback Incentives eXchange AFIX visits are conducted when a provider has 5> children in the current age cohort in order to assess coverage rates.

26

AFIX/WVSIIS REPORTING

Conducting AFIX Visits • Division of Immunization Services (DIS) staff pulls patients’

records directly from WVSIIS • A “patient listing” and “missing immunizations” report are then provided to the VFC contact for review • Provider staff (VFC contact) then must review/update any

patient records in WVSIIS and inactivate any patients who are no longer seen in the practice prior to the site visit

27

AFIX/WVSIIS REPORTING

Conducting AFIX Visits • Once updates have been completed, DIS staff will pull a final

patient listing from WVSIIS and run coverage rates to review with provider during the site visit

• Coverage rates are based solely on WVSIIS data and will not be entered at the time of the visit

28

AFIX/WVSIIS REPORTING

In order to achieve good coverage rates, a provider must strive to:

• Report all immunizations given (both private and VFC) to WVSIIS

• Mark any patients who are no longer seen by the practice as “inactive” in WVSIIS • Not take ownership of a patient unless the patient is yours

29

AFIX/WVSIIS REPORTING

In order to achieve good coverage rates, a provider must strive to:

• Report previously administered immunizations to WVSIIS

• Vaccinate children for the complete 4-3-1-3-3-1-4 series by the age of 24 months

• Reduce missed opportunities for vaccination – immunize at all sick and well visits

• Have a reminder/recall system in place

30

CONTACT Glora A. Crouch, BSRT R AFIX Coordinator/VFC Program Specialist 350 Capitol Street, Room 125 Charleston, WV 25301 Phone: (304) 356-4044 Fax: (304) 558-6335 Email: glora.a.crouch@wv.gov Website: www.dhhr.wv.org/oeps/immunization

31