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:
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.
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 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).
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:
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.
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:
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.
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:
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.
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 (email@example.com) 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.
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 (firstname.lastname@example.org). 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.
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.
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: