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By Disease or Condition

Immunizations

Alcohol and Drug Use

Smoking and Tobacco Use

Sexual and Reproductive Health

Infectious Diseases

Health Care-Associated Infections

Children and Adolescents

Immigrant Health


NYC VFC Provider Requirements: Vaccine Storage & Handling

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 and will be required for all VFC vaccine storage starting January 1, 2018.

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. Starting January 1, 2018, the use of combination refrigerator/freezer units for VFC vaccine storage will not be allowed.

Please note that dormitory style units are PROHIBITED and therefore not acceptable for storage of any vaccines. Dormitory style units are single door units that have a freezer section within the refrigerator compartment.

For guidance on how to appropriately setup your vaccine storage unit refer to the Vaccine Refrigerator (PDF), Stand Alone Refrigerator (PDF) & Freezer (PDF) 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 (PDF), page 28.

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 Thermometer Guide (PDF).

Vaccine Security

It is important that vaccine storage units have power at all times and that measures be taken to secure the power supply. The 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 (PDF)). 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

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 once per day. Once 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 46°F/8°C and above 36°F/2°C).

Keep freezer temperatures within recommended range (below 5°F/-15°C and above -58°F/-50°C).

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 (PDF) pages 13-32. For refrigerator and freezer temperature log templates see:

Celsius Refrigerator and Freezer Temperature Logs

Freezer Temperature Log (PDF)

Refrigerator Temperature Log (PDF)

Fahrenheit Refrigerator and Freezer Temperature Logs

Freezer Temperature Log (PDF)

Refrigerator Temperature Log (PDF)

Thermometers

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 have a buffered probe and the probe must be placed in a central area inside each refrigerator and freezer compartment. Providers are required to follow manufacturer's recommended schedule for recalibration. (See NYC Certificate of Calibration Checklist for Thermometer (PDF))

In addition, CDC recommends the use of a continuous monitoring and recording digital data logger (DDL) thermometer with a buffer encased probe set to record at a maximum interval of every 30 minutes. Starting January 1, 2018, use of continuous DDL thermometers with a buffered encased probe will be required for all VFC storage units. The thermometer should have 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 DDL thermometer should have a detachable buffered probe.

For more guidance on best practices on thermometers and continuous monitoring, please refer to the CDC Storage and Handling Toolkit (PDF), pages 13-32.

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

Minimum and maximum temperature reached during incident

Cumulative time out of range

Ambient room temperature

Description of the problem

Action(s) taken

Outcomes

Name and signature of the person documenting the incident

In the event of a temperature excursion, providers must quarantine the affected vaccine within a stable 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 program procedures for returning spoiled vaccine. (See Returning Spoiled or Expired VFC Vaccines below)

Providers must document all excursion incidents using the Temperature Excursion Incident Report. Reports should then be sent to the NYC VFC program, along with supporting documentation from the vaccine manufacturer(s), via email (nycimmunize@health.nyc.gov) or fax (347-395-2559). If faxed, please fax to the attention of the Provider Quality Assurance (PQA) Unit. Reports should also 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 (PDF), pages 13-32.

Spoiled and Expired Vaccine

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 (347-396-2404), fax (347-396-2559), or email (nycimmunize@health.nyc.gov). 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.

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 (PDF) on how to report spoiled and expired vaccines. Once notified of your submission, the McKesson Specialty 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 Replacement Policy

NYC VFC Program implemented a Vaccine Replacement Policy for vaccine loss or wastage due to negligence or mismanagement of the vaccine in September 2011. Starting December 1, 2018, 100% of vaccines spoiled and expired due to negligence or mismanagement must be replaced on a dose per dose basis. (See Vaccine Replacement Policy (PDF)) 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

Exceptions: 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

Other Resources

Enrollment & Re-Certification

Provider Site Visits

Vaccine Management

Administering Vaccines

Vaccine Fraud and Abuse