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VFC Topics for Providers
NYC Vaccines for Children (VFC) Program
The Vaccines for Children (VFC) Program is a federally funded program that supplies providers in private and public health care facilities with free vaccines for eligible children. Besides VFC, additional types of funding may be allocated to cover additional populations.
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VFC Eligibility Requirements
In NYC, children 18 years of age and under, that fall under any of the following categories are eligible for publicly-funded vaccine:
- Medicaid eligible
- Underinsured: A child who has commercial (private) health insurance but the coverage does not include vaccines, a child whose insurance covers only selected vaccines (VFC-eligible for non-covered vaccines only), or a child whose insurance caps vaccine coverage at a certain amount. Once that coverage amount is reached, the child is categorized as underinsured (Underinsured children are eligible to receive VFC vaccine only through a Federally Qualified Health Center (FQHC) or Rural Health Clinic (RHC)
- Native-American or Alaskan Native
- Enrolled in Child Health Plus B (CHPlus B)
Please note that the following children are NOT considered underinsured:
- Children whose insurance covers a portion of the cost of the vaccine but not the full amount. In this case providers should consider renegotiating the contract with the insurance company
- Children whose insurance covers vaccines but have a high deductible and whose deductibles have not been met
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Provider Quality Assurance Unit
In New York City, the Provider Quality Assurance (PQA) Unit oversees the review and evaluation of VFC provider practices and is implemented through VFC and AFIX (Assessment, Feedback, Incentives, and eXchange) site visits. These visits involve storage and handling evaluations, chart reviews, and analysis of electronic immunization records, vaccine ordering, and vaccine utilization through NYC's Citywide Immunization Registry (CIR).
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Vaccine Management Unit (VMU)
The Vaccine Management Unit (VMU) is responsible for processing over 3.3 million doses of publicly funded vaccine for nearly 1,600 immunization providers each year. This unit ensures that providers receive vaccines in accordance with their vaccine reporting to the CIR and alerts the PQA Unit of any issues that may require follow-up.
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City Immunization Registry (CIR)
The Citywide Immunization Registry (CIR) is a central record-keeping system used to track the immunization status of individual children and monitor immunization levels in the population. The CIR is accessible to licensed health care providers, parents, and agencies authorized by DOHMH to retrieve immunization records in order to ensure that children receive all required immunizations. The CIR provides two methods for exchanging immunization data with providers: 1) through the online registry, a web-based application or 2) through interfaces with provider electronic health records (EHRs), a requirement for providers participating in the meaningful use incentive program. For more information on the CIR click here.
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What are the benefits of participating in the VFC Program?
- It will enhance your ability to provide government purchased vaccine to your eligible patients and reduce your out-of-pocket costs.
- It will allow you to fully vaccinate all children with ACIP recommended vaccines
- You will no longer have to refer patients for immunizations.
- It will help increase community immunization coverage levels.
- The VFC Program offers a variety of manufacturers and vaccine.
- Medicaid provides a vaccine administration fee of $25.10 per VFC vaccination.
- Provider enrollment is easy and vaccines are delivered directly to your private office or health care facility within two weeks of placing your order.
- You will have access to excellent customer service to address your questions.
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How to enroll in the VFC Program
- Download and complete the Provider Enrollment Form & Information Update Form or contact the NYC DOHMH Bureau of Immunization Provider Quality Assurance (PQA) Unit by calling (347) 396-2404.
- Complete the forms, scan them, and e-mail them to firstname.lastname@example.org. If you cannot e-mail the form, please fax it to (347) 396-2559, attention PQA Unit.
- Once your paper work is processed, you will be contacted by a PQA staff member to schedule a New Enrollment site visit. You will not be able to order vaccine until we conduct a site visit and ensure that your practice meets all storage and handling guidelines.
- You will need to prepare your office and staff for a New Enrollment site visit to review both the administrative requirements of the program and the proper storage and handling guidelines for the vaccines.
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The NYC DOHMH VFC program requires providers to re-enroll annually through the CIR Online Registry. Providers will receive notices once the online re-enrollment form is deployed in the CIR Online Registry. Subsequent reminders will be sent to remind providers who have not re-enrolled. It is important that the contact information we have on file for site is up-to-date at all times.
- VFC re-enrollment must be completed online through the NYC Online Registry each year. By completing the re-enrollment process, providers agree to the VFC program requirements listed in the Vaccine Recipient Agreement. After completing the re-enrollment form, providers will receive a confirmation that the NYC VFC program received the completed form
- Beginning 2014, the physician-in-charge, vaccine coordinator, and back-up vaccine coordinator at each VFC facility will be required to complete the You Call The Shots: Vaccine Storage and Handling and Vaccines For Children (VFC) web-based training courses and submit certificates of completion as a part of re-enrollment. For further guidance on how to complete training's click here.
Most of the materials provided in the enrollment package may be downloaded directly from the VFC website. (See the ���forms, job aids, and charts" section).
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What to expect during your site visit
Providers new to VFC should expect to set aside two hours for the site visit in order to meet with a representative from the VFC Program to review the following topics:
- VFC eligibility screening procedures;
- Verification of information in the Provider Profile;
- The VFC Site Visit Questionnaire;
- VFC vaccine administration, storage and handling;
- VFC program policies and implementation;
- Feedback and correction of any identified problems.
Previously enrolled providers should expect to set aside two hours for the site visit in order to meet with a representative from the VFC Program to review the topics outlined above and present a number of patient charts for review. Based on the volume of patients seen at your practice, the number of charts reviewed may vary and should be randomly selected by the VFC Program or by your staff.
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Types of Provider Site Visits
Site visits are conducted to ensure that VFC and other publicly funded vaccines are stored, handled, distributed, and administered in accordance with the laws, policies, and recommendations of: the VFC Program, the Advisory Committee on Immunization Practices (ACIP), and the Childhood and Adolescent Immunization Schedules, as published by the Centers for Disease Control and Prevention (CDC).
In NYC, the PQA Unit field staff are responsible for conducting provider site visits. The PQA unit chief may accompany field staff on visits to ensure optimal services.
All providers are visited at minimum, once every two years. Additional visits may be scheduled if needed (e.g., practice moving to another location, large order histories or unusual ordering patterns, prior reports of vaccine fraud or abuse or suspected misuse of VFC vaccines, large amount of vaccine loss due to improper storage and handling, and previous unacceptable storage and handling practices).
Your practice���s main physician and vaccine coordinator must be available during site visits. All other staff members involved in the storage, handling, accountability, and administration of publicly funded vaccine should also be present for feedback, if possible.
There are five types of provider site visits conducted by the NYC VFC program:
- VFC New Enrollment site visit:
The New Enrollment site visit is conducted as soon as the provider enrolls in the VFC program. This visit must be conducted within 2 weeks of enrollment and it must be conducted prior to processing the first VFC vaccine order. This visit is to ensure that providers enrolled in the VFC program are meeting the requirements of vaccine storage and handling and to educate providers on VFC requirements so that vaccines are stored, distributed, handled, accounted, and administered only to VFC-eligible children in accordance with the laws, polices, and recommendations of: the VFC Program, the Advisory Committee on Immunization Practices (ACIP), and the Childhood and Adolescent Immunization Schedules, as published by the Centers for Disease Control and Prevention (CDC). During this visit, PQA field staff complete the New Enrollment Site Visit Questionnaire and Checklist.
- VFC Compliance site visit:
The VFC Compliance site visit is conducted at minimum, once every two years. This visit is to ensure that VFC and other publicly funded vaccines are stored, handled, distributed, and administered in accordance with the laws, policies, and recommendations of: the VFC Program, the Advisory Committee on Immunization Practices (ACIP), and the Childhood and Adolescent Immunization Schedules, as published by the Centers for Disease Control and Prevention (CDC). During this visit, PQA field staff complete the VFC Site Visit Questionnaire and provide you with feedback.
- Combined VFC Compliance AFIX (Assessment, Feedback, Inventive, and Exchange) site visit:
The combined VFC Compliance and AFIX site visit may be conducted every two years. This visit is to ensure that VFC and other publicly funded vaccines are stored, handled, distributed, and administered in accordance with the laws, policies, and recommendations of: the VFC Program, the Advisory Committee on Immunization Practices (ACIP), and the Childhood and Adolescent Immunization Schedules, as published by the Centers for Disease Control and Prevention (CDC). The AFIX portion of this visit assesses immunization coverage through the CIR among the 19-35 month-old patient population and among the 13-17 year old patient population prior to the visit. The results, including coverage rates and patient lists of children missing vaccines, are reviewed during this site visit. PQA field staff also complete the VFC Site Visit Questionnaire and provide you with feedback.
- Unannounced Storage and Handling Site Visit:
The Unannounced Storage and Handling site visit is conducted as needed. This visit is to follow-up on whether providers are meeting requirements that may have been recommended during a previous site visit in terms of storage, handling, and accountability. Providers are not alerted about this visit before it is conducted. Unannounced site visits are also considered when a provider fails to adhere to recommended vaccine storage and handling practices (e.g. storing food and drinks in the refrigerator, not rotating vaccine stock, or finding expired vaccine in the refrigerator), or when a provider fails to maintain a proper amount of privately purchased vaccine in their refrigerator.
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Provider Vaccine Management Requirements
All providers must be able to meet the following requirements in order to participate in New York City's VFC program:
- Designate a physician-incharge, a primary vaccine coordinator and at least one back-up vaccine coordinator who is able to perform the same responsibilities as the primary vaccine coordinator in the event that the primary person is unavailable. These positions will be responsible for all vaccine management within the office. (See the Vaccine Management Job Aid)
- The designated vaccine coordinator and backup will be responsible for the following vaccine management activities:
- Adjusting the temperature of a vaccine storage unit, and -
- Documenting the temperature on the temperature logs for each storage unit.
- Reviewing temperature logs weekly if daily monitoring is being conducted by the backup person monitors temperatures daily, the primary vaccine coordinator should review weekly. If the vaccine coordinator monitors temperatures daily, the backup person should review logs weekly.
- Training other staff who are responsible for administering vaccines or who may be required to transport vaccine in an emergency situation. A simple log sheet with the staff member's name and date of training should be kept as documentation.
- Unless otherwise noted, the vaccine coordinator and/or backup should be the VFC contacts for the office.
Vaccine Management Plan
The NYC VFC Program requires that all VFC providers have a Vaccine Management Plan and review it with their staff at least once a year. Providers may develop their own management plan or use the NYC VFC Vaccine Management Plan (PDF) template. The Vaccine Management Plan should be simple, and the processes outlined within it should be presented in a clear and concise manner. Both routine and emergency vaccine management components should be included in the plan. The emergency component should contain guidance on what to do in the event of refrigerator or freezer malfunctions, power failures, natural disasters, or other emergencies that might compromise appropriate vaccine storage conditions. Providers are required to develop policy, complete with protocols and procedures, for maintaining the vaccine cold chain during transport to off-site emergency storage locations.
- The routine vaccine management component should include guidance on the following:
- Ordering vaccines
- Controlling inventory
- Storing vaccines and monitoring storage conditions
- Minimizing vaccine wastage
- Vaccine shipping, including receiving, packing and transporting
- The emergency vaccine management component should include guidance on the following:
- Person(s) responsible for preparing and transporting vaccine, including contact information
- How this person will be notified that vaccine needs to be moved
- Location that will receive vaccine
- How receiving location will be notified of transport
- How to pack vaccine for transport
- Worksheet to document vaccine involved in power or equipment failure
For further guidance on what to include in your plan providers should look at the CDC���s Checklist for Safe Vaccine Handling and Storage (PDF).
Proper vaccine inventory management is essential for all VFC-enrolled providers. Providers should refer to the NYC VFC How to Do a Physical Inventory Job Aid, when conducting vaccine inventory. Because providers are also required to submit current inventory of their publicly-funded vaccines every time they place a vaccine order, it is important that providers develop and maintain complete, accurate and separate stock records for both public and private vaccines. The requirement to keep separate records does not necessitate having separate storage units for public and private vaccines. Providers must be able to distinguish between their public and private vaccine stock. Proper documentation of all administered VFC vaccine doses will help to ensure this. (See Reporting Administered Vaccine Doses below)
For more guidance on best practices on vaccine inventory management, please refer to the CDC Storage and Handling Toolkit, pages 78-87.
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Vaccine borrowing should only occur in rare occasions when there is lack of appropriate stock vaccine due to unexpected circumstances such as the vaccine is about to expire or shipment delays due to vaccine unavailability or vaccine shortages. Providers are required to document all instances using the VFC Vaccine Borrowing Report and have documentation available to VFC Program staff during site visits.
Vaccine borrowing should NOT be a routine practice. VFC-enrolled providers are expected to maintain an adequate inventory of vaccine for both their VFC and non-VFC-eligible patients at all times. Vaccine borrowing should NOT change this expectation.
VFC vaccine cannot be used as a replacement system for a provider���s privately purchased vaccine inventory unless the vaccine is about to expire and a provider wants to avoid vaccine wastage. The provider must assure that borrowing VFC vaccine will not prevent a VFC-eligible child from receiving a needed vaccination because VFC vaccine was administered to a non-VFC eligible child.
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VFC-enrolled providers needing to transfer vaccines must contact and receive approval from the NYC VFC program before attempting to transfer any VFC vaccines. Vaccine transfer requests are approved on a case by case basis and generally in the event of an emergency.
- Such emergencies consist of:
- refrigerator/freezer malfunctions
- power failures, natural disasters or other emergencies that might compromise appropriate vaccine storage conditions
If requests are approved, the physician-in-charge, vaccine coordinator, or the back-up vaccine coordinator at each site must designated a point person responsible for packing, relocating, receiving, and unpacking vaccine transfers. Each site���s designated point person must be available during the entire vaccine transfer.
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VFC Vaccine Orders
VFC vaccine is ordered online using the City Immunization Registry (CIR). Orders are completed using the CIR���s Online VFC Ordering and Management Tool and tracked using the CIR���s Online Vaccine Order Tracking Tool.
The Online VFC Ordering and Management Tool ensures that providers receive an ample supply of vaccine to immunize their patients while minimizing the total number of orders placed by the provider throughout the year; and makes vaccine order recommendations based on the provider���s Doses Administered Report (DAR).
- DAR is the total number of doses reported to the CIR as administered to children eligible for publicly funded vaccines in a 1-year period (numerator) divided by the total number of publicly-funded vaccines distributed to the facility in the same year (denominator)
The process for ordering VFC vaccine online consists of six simple steps outlined below.
Once the CIR���s Online VFC Ordering and Management Tool is accessed, providers must:
- Review vaccine order history
- Confirm, enter or update the following information
- Shipping and storage details
- Refrigerator and freezer temperatures
- Storage used for VFC vaccines
- Enter current VFC vaccine inventory
- Enter replenished vaccine inventory
- Enter VFC order quantities
- Confirm order
- Receive confirmation number
For a step-by-step guide on how to order vaccine through the CIR click here.
Once a VFC vaccine order is submitted, the NYC VFC program reviews and approves all orders based on a number of criteria:
- Is the provider ordering within their ordering tier (correct part of the month and frequency)?
- Providers are assigned bimonthly, monthly, and quarterly ordering tiers base on an array of factors (e.g., size of practice, number of vaccines administered, VFC population, etc.)
- Is the provider appropriately accounting for VFC vaccine within the CIR? (see Reporting Administered Vaccine Doses below)
- Provider inventory on hand (see Vaccine Management Inventory above)
- Are providers ordering more vaccine than recommended?
- Vaccine recommendations are primarily based on a provider���s DAR and availability of a vaccine safety stock. Secondary factors taken into account are prior ordering history, seasonality, relevant results from site visits, and whether there is adequate vaccine at McKesson for distribution.
Depending on the findings of the review, orders are approved, adjusted, or rejected. If an order is adjusted or rejected, providers are notified of this change by the Vaccine Management Unit (VMU) via phone or email. An explanation of why an order was adjusted or rejected is given at this time as well.
Receiving Vaccine Shipments
The primary vaccine coordinator and the back-up vaccine coordinator are responsible for all vaccine shipments. All VFC vaccine shipments received from the distributor contain heat indicators. These indicators help to establish whether cold chain was compromised during transit to provider sites. The monitors are single-use devices that come in three basic types:
- Those that indicate whether packages have reached temperatures that are too warm (located in outer of box),
- Those that indicate whether packages have reached temperatures that are too cold (located in inner box)
These types of monitors are designed to be irreversible indicators of inappropriate temperatures. The vaccine coordinator and back-up vaccine coordinator are responsible for receiving all vaccine shipments and verifying that vaccine cold chain was maintained during transit to their site. It is important that vaccine cold chain monitors be checked and the temperature inside the transport unit be documented as soon as shipments arrive at your site. The Receiving Vaccine Shipments Checklist must be completed as well. If vaccines were shipped and received appropriately, immediately store them in proper storage units at recommended temperatures.
Please note the frozen vaccines are shipped direct from the manufacturer in specialized boxes that do not contain heat indicators. Immediately upon arrival the vaccine coordinator and back-up vaccine coordinator should go through the Vaccine Shipment to determine the vaccine���s viability. There will be paper work included in the shipment box to address the length of time the vaccines will remain viable during shipping. If that time has been exceeded, upon shipment arrival, you should contact the VFC program. For more guidance on receiving vaccine shipments refer to the CDC Storage and Handling Toolkit, pages 88-90.
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It is not acceptable clinical practice to pre-draw vaccines into syringes. Providers should draw vaccine only at the time of administration to ensure that the cold chain is maintained and the vaccine is not inappropriately exposed to light. Guidelines for vaccine preparation should be outlined in the provider���s Vaccine Management Plan. For more information on vaccine preparation click here.
Vaccine Information Statements (VIS):
Providers are required to give patients the most current VIS before the administration of each dose of vaccine. The latest VIS can be found on the Immunization Action Coalition website and CDC website. Providers are also required to document this action in the patient���s permanent medical record.
- The following should be documented and available for review during VFC compliance site visits:
- which specific VIS was given (e.g., MMR)
- the date of publication of the VIS
- the date the VIS was provided
Additionally, providers must maintain records in accordance with the National Childhood Vaccine Injury Act, including reporting clinically significant adverse events to the Vaccine Adverse Event Reporting System (VAERS). Please note that adverse events can be reported online through the City Immunization Registry (CIR) and transmitted to the CDC on your behalf.
Vaccine Administration Fee:
Providers are not allowed to charge NYC VFC eligible children for vaccines; however they can charge a vaccine administration fee no greater than the current State Medicaid program reimbursement amount of $25.10. Please note that an eligible child cannot be denied vaccine due to the inability of the child���s parent or guardian to pay the vaccine administration fee.
Documenting VFC Eligibility:
VFC-enrolled providers are required to document VFC/publicly funded vaccine eligibility for all children immunized at their practices. Eligibility can be documented in paper form using the Vaccine Administration Record form or electronically in the provider���s electronic medical record.
Reporting Administered Vaccines Doses
VFC-enrolled providers are also required to report administered vaccine doses for all VFC eligible patients to the VFC Program through the City Immunization Registry (CIR). Reporting to the CIR can be done electronically or online. When reporting administered vaccines doses to the CIR the VFC eligibility must be indicated. The following should be indicated as well:
- Vaccine lot number
- Vaccine manufacturer
- Expiration date
Reported doses are used to calculate a provider���s Doses Administered Report (DAR) and findings are used to ensure that:
- VFC vaccines are administered only to eligible children
- Mandatory CIR requirements are met
- Providers order vaccines in accordance with the number of children seen on a yearly basis
The NYC VFC Program sends providers their DAR report quarterly and based on report findings the following actions are taken:
- The Vaccine Management Unit (VMU) adjusts vaccine orders for providers with DARs < 80%
- The Provider Quality Assurance (PQA) Unit conducts VFC Compliance Site Visits to determine why DAR is low
- The CIR staff conduct outreach to providers with low DARs < 60% to resolve issues with reporting of vaccines administered and to train providers to use the CIR���s Online Registry VFC vaccine ordering tool to order an appropriate amount of vaccine for their VFC-eligible population
For more information on how to report administered to the CIR click here.���
Vaccine Storage and Handling Practices
All providers are required to maintain proper vaccine storage and handling practices. These practices can be the responsibility of the vaccine coordinator or can be delegated to another staff member. If the practices are delegated, the vaccine coordinator is responsible for monitoring these activities periodically.
Providers are required to follow these storage & handling practices:
- Store vaccines that require refrigeration in the middle of the refrigerator compartment away from the coils, walls, floor, and cold air vent
- Store vaccines that require freezer storage in the middle of the freezer compartment, away from the walls, coils, and peripheral areas
- Store vaccine with enough space to allow for cold air circulation around the vaccine
- Ensure that private and public vaccine stock are separated and labeled
- Do not store vaccines on the door or in the crisper compartments
- Do not store food or beverages (other than water) in vaccine storage unit(s)
- Remove vegetable bins from the refrigerator; replace with cold water bottles
- Store all opened and unopened vials of vaccine in their boxes inside the appropriate storage unit so that their contents and expiration dates are easily visible
- Store bottles of water (labeled ���do not drink���) in the refrigerator and ice packs in the freezer to help maintain the internal temperature(s) of the unit(s)
- Keep vaccines organized and properly labeled
- Open only one vial, or box, of a particular vaccine at a time to control vaccine use and allow easier inventory control. On each opened vaccine vial indicate on the label the date and time it was reconstituted or first opened
- Store vaccine products that have similar packaging in different locations in the storage unit to avoid confusion and medication errors
- Rotate vaccine stock by placing vaccines with shorter expiration dates in front of those with longer expiration dates; check for short-dated vaccine
- Notify the PQA Unit of any vaccine doses that will expire before they can be administered. Only with the approval and direct guidance of the PQA Unit and only if the cold chain can be ensured, redistribute short-dated vaccines to high-volume providers who are able to administer it before it expires
- Take immediate action to correct improper vaccine storage conditions and document actions taken
Vaccine Storage Units
Providers must have appropriate vaccine storage units that can store vaccine and maintain proper conditions. If a provider does not have the appropriate storage units, the Provider Quality Assurance (PQA) Unit will work with providers to obtain storage units that are acceptable.
The use of stand-alone refrigerator and stand-alone freezer units, meaning a self-contained unit that only refrigerates or freezes and is suitable for vaccine storage is strongly recommended and considered best practice. If you are using or desire to use a combination refrigerator/freezer unit, the CDC recommends using it for refrigerated vaccine only and using a separate standalone freezer to store frozen vaccines. Dormitory style refrigerator/freezer units and single door refrigerator/freezer units are NOT acceptable for the permanent storage of vaccines. Any frozen vaccines (e.g. varicella-containing vaccines) should NEVER be stored in these types of storage units. For guidance on how to appropriately setup your vaccine storage unit refer to the Vaccine Refrigerator & Freezer Setup guides.
Vaccine Storage Unit Maintenance
Routine maintenance of vaccine storage units ensures proper operation and equipment longevity. Providers should have daily, monthly, and periodic maintenance tasks in place for all of their units. Refrigerator and freezer units should be cleaned regularly and unit doors seals checked. Additionally, providers with frost-free freezers should check drain pans for mold and clean if present. (See the Vaccine Management Job Aid) For more guidance on best practices for vaccine storage unit maintenance, please refer to the CDC Storage and Handling Toolkit, pages 35-38.
Purchasing New Vaccine Storage Units
Purchasing a new vaccine storage unit may require planning and existing equipment may need to be used for a certain amount of time until new equipment can be purchased. The use of dorm-style or bar-style refrigerators or freezers is not allowed for ANY vaccine storage, even for temporary storage. VFC providers are required to have a Vaccine Management Plan in place to deal with such emergencies. For guidance on how to select appropriate vaccine storage units refer to the NYC VFC Vaccine Storage Unit Checklist (PDF).
It is important that vaccine storage units have power at all times and that measures be taken to secure the power supply. The NYC VFC Program requires that providers post warning notices such as, ���Do Not Unplug��� on refrigerator/freezer outlets and circuit breakers to prevent power from being disconnected (see Safeguard Your Power Supply Job Aid). In addition to that, refrigerators and freezers units cannot be connected to an outlet with a ground-flow interrupter (GFI) or one activated by a wall-switch.
Some additional recommendations for vaccine security are:
- Limiting access to the vaccine supply to authorized personnel only
- If possible, installing locks on refrigerators and the electrical plug
- Safeguarding public vaccines by providing facility security, such as temperature alarms and restricted access to vaccine storage and handling areas
- Placing plug guards to prevent accidental dislodging of the wall plug
- In larger clinics, providing a source of backup power (generator) and a security system
Temperature monitoring should be the primary responsibility of the vaccine coordinator and backup. If other staff must monitor temperatures, those persons must be trained on how to respond to and document actions taken when temperatures are outside the appropriate range.
- Assign the primary responsibility from maintaining temperature logs to one person, along with one backup person.
- All staff members working with vaccines must be familiar with proper temperature monitoring. The physician or practice owner retains ultimate responsibility for the practices of their staff and should consider assuming oversight of temperature monitoring
- Post a temperature log on the vaccine storage unit door or nearby in a readily accessible and visible location.
- Record refrigerator and freezer temperatures twice each day (in the morning and afternoon). Twice-daily temperature monitoring and recording is required even if a continuous graphing/recording thermometer or a digital data logger is used.
- Maintain an ongoing file of temperature logs, and store completed logs for 3 years.
- Keep refrigerator temperatures within recommended range (below 46oF/8oC and above 35oF/2oC)..
- Keep freezer temperatures within recommended range (below 5oF/-15oC and above -58oF/-50oC).
- Take immediate action to correct improper vaccine storage conditions, including inappropriate exposure to light and inappropriate exposure to storage temperatures outside the recommended ranges. Document actions taken on the temperature log.
For more guidance on best temperature monitoring practices, please refer to the CDC Storage and Handling Toolkit, pages 62-65. For refrigerator and freezer temperature log templates go here (Fahrenheit & Celsius).
At a minimum, providers must have a working thermometer calibrated with certification in accordance with the National Institute of Standards and Technology (NIST) or the American Society for Testing and Materials (ASTM) Standards. Thermometers must be placed in a central area inside each refrigerator and freezer compartment. Providers are required to follow manufacturer's recommended schedule for recalibration.
In addition, CDC recommends the use of a digital thermometer with a bio-safe glycol-encased probe that will measure liquid temperature. The thermometer should also be able to provide continuous data monitoring information in an active display and be placed on the outside of the unit door to allow for reading temperatures without opening the unit door. The data stored in the thermometer should be easily downloadable for review. This means that the digital thermometer should have a detachable probe (that is kept in the glycol-filled bottle). (See CDC Thermometer Checklist PDF)
For more guidance on best practices on thermometers and continuous monitoring, please refer to the CDC Storage and Handling Toolkit, pages 38-46.
Responding to Storage and Handling Alerts
Providers are required to take immediate action when improper vaccine storage and handling conditions occur. The primary vaccine coordinator and back-up vaccine coordinator should be notified immediately and actions should be taken to resolve the issue. All actions must be documented and available to NYC field staff during site visits. The following items should be documented:
- Date and time of occurrence
- Temperature of affected storage units at the time of incident
- Ambient room temperature
- Description of the problem
- Action(s) taken
- Name and signature of the person documenting the incident
In the event of a temperature excursion, providers must quarantine the affected vaccine within the storage unit and label the vaccine as ���DO NOT USE���. Vaccine manufacturers should then be contacted to establish whether the quarantined vaccine is still viable.
- If the manufacturer determines that the quality of the affected VFC vaccines has not been compromised and may continue to be used, remove the vaccine from quarantine
- If the manufacturer determines that the affected VFC vaccines are NOT approved for further use, label them as ���spoiled��� and follow the NYC VFC Program procedures for returning spoiled vaccine. (See Returning Spoiled or Expired VFC Vaccines below)
Providers must document all excursion incidents using the NYC VFC Temperature Excursion Incident Report. Reports should then be filed with relevant temperature logs. Any documents from the manufacturer(s) should be filled as well. All documentation must be readily available if requested by the NYC VFC Program.
In the event of storage unit malfunctions, power failures, or natural disasters, providers should follow guidelines outlined in the emergency vaccine management component of their Vaccine Management Plan. For more guidance on handling inappropriate vaccine storage conditions refer to the CDC Storage and Handling Toolkit, pages 66-77.
Providers are required to immediately notify the PQA Unit of any vaccine cold chain failure incidents involving publicly funded vaccines after discovery of the incident. This can be done via phone, fax, or email. The PQA Unit will then provide guidance on how to document and report the incident. It is important that providers implement written procedures for reporting and responding to losses resulting from vaccine expiration, wastage, and compromised cold chain. All wasted/expired vaccine should be removed from storage containers with viable vaccine to prevent inadvertent administration. It should be returned, as directed by PQA, for excise tax credit (see Returning Spoiled or Expired VFC Vaccines below).
Returning Spoiled or expired VFC Vaccines
All spoiled and expired vaccines must be reported to the NYC VFC Program. Spoiled and expired vaccines can be reported using the City Immunization Registry (CIR). Providers should log into the online registry, click on the VFC Icon and select the VFC Vaccine Returns tab. Under this tab you will find instructions on how to report spoiled and expired vaccines. Once notified of your submission, the NYC VFC Program will mail out a postage-paid mailing labeling for returning the vaccines. DO NOT call McKesson Specialty, UPS, or Federal Express to arrange a pickup. If you do call McKesson Specialty, you will be charged for the pickup.
Please note that the following should NEVER bet returned, but must be properly disposed as medical waste and with the exception of privately purchased vaccines, reported to the NYC VFC program as wastage.
- Privately purchased vaccines (non-VFC)
- Vaccines with expiration dates that are more than 6 months old
- Vaccine drawn-up into the syringes but not administered
- Multi-dose vials from which some vaccine has already been withdrawn
- Broken vials
- Used syringes with or without needles
- Non-VFC vaccines
Vaccine Reimbursement Policy
NYC VFC Program implemented a Vaccine Reimbursement Policy for vaccine loss or wastage due to negligence or mismanagement of the vaccine in September 2011. The following thresholds are considered when assessing vaccine reimbursement and further follow-up and education:
- If a site has a total cumulative vaccine wastage due to negligence or mismanagement exceeding 5% of the provider���s total vaccine distribution in one year
- If the site is a high vaccine volume provider and vaccine wastage due to negligence or mismanagement is <5%, providers will still be requested to reimburse if vaccine spoilage >500 doses in one year.
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VFC Vaccine Fraud and Abuse and Non-Compliance Procedures
To prevent, identify and investigate any suspected cases of fraud and abuse of VFC vaccine, the NYC Bureau of Immunization follows “The NYC VFC Vaccine Fraud and Abuse Policy” provided below. If the BOI identifies that publicly funded vaccine were misdirected to non-VFC eligible children, they have the right to request that the vaccine is reimbursed to the VFC program.
To report suspected cases of fraud or abuse of the VFC Program, call the Bureau of Immunization, Provider Quality Assurance Unit at 347-396-2404 or the New York State Office of the Medicaid Inspector General Fraud Hotline at 877-873-7283. Complaints may also be filed on-line.
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Letters to Providers/NYCDOHMH Bureau of Immunization Publications
To search for current and past letters, click on the link below for the NYC DOHMH Archive of Letters to Providers. These letters may be used by you and your staff for reference on how best to administer the vaccines, read about program changes, and about vaccine shortages and delays.
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Additional Links and Resource Materials
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For more information about the Vaccines for Children program or to enroll in the program, call (347) 396-2404 or email email@example.com.
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