Preparing for a Vaccines for Children (VFC) site visit can feel overwhelming. Site visits are conducted to insure that vaccines are being ordered in appropriate quantities, stored and handled properly, and that only VFC eligible patients are receiving VFC vaccines, with the overarching goal of ensuring children who may not otherwise be vaccinated have the opportunity to receive viable vaccines.
Specific regulations may vary state to state, but the following information covers basic CDC guidelines in regards to proper storage and handling of VFC vaccine. Check with your state immunization program if you have any questions.
CDC recommends the following vaccine storage unit types (in order of preference): pharmaceutical grade stand-alone or combination units (preferred); household/commercial stand-alone units; household/commercial combination units using the refrigerator section only.
Pharmaceutical: Also called “purpose-built,” these units are designed by the manufacturer specifically to store vaccines or other biological materials. Check with the manufacturer to ensure the unit will provide superior temperature uniformity and recovery, as not all pharmaceutical units perform to the same standard.
Commercial: Although usually intended to store food and beverages, commercial units are often larger and more powerful than the household units found in most homes. Though these units are intended to meet the higher demands of larger facilities, these units are not specifically built for the storage of biological materials.
Household (non-commercial/domestic): These units are usually smaller than commercial units and are intended for use in small offices and in homes – typically for food storage. However, just like commercial units, they are not designed specifically for the storage of biological materials. Such units are usually available in common home supply stores.
The assessor will identify what type of unit is being used to store the vaccine. Even units storing strictly private stock will be accessed because those vaccines may be administered to VFC patients.
Dorm- and bar-style units are prohibited for vaccine storage. Vaccines stored in dorm-style units are considered non-viable and must be returned to the centralized distributor. CDC recommends the following vaccine storage unit types (in order of preference): pharmaceutical grade stand-alone or combination units (preferred); household/commercial stand-alone units; household/commercial combination units using the refrigerator section only.
Temperature Monitoring Evaluation
Each unit will be checked for a temperature monitoring device. Routine review and accessibility of temperature data is critical for determining whether vaccine has been properly stored and for assessing usability of vaccine that was involved in a temperature excursion. To meet VFC Program requirements the device must also be equipped with:
- A temperature probe
- An active temperature display that can be easily read from the outside of the unit
- The capacity for continuous monitoring and recording capabilities where the data can be routinely downloaded. The following are additional recommended features for these devices:
- Alarm for out-of-range temperatures
- Current, minimum, and maximum temperatures display
- Low battery indicator
- Accuracy of +/- 1°F (0.5°C)
- Memory storage of at least 4,000 readings
- User programmable logging interval (or reading rate) recommended at a maximum time interval of every 30 minutes
- Use of a probe that best reflects the temperature of the vaccine (such as a buffered probe)
The assessor may ask the following questions in regards to your temperature monitoring:
- Is the temperature monitoring device a continuous monitoring and recording device (e.g., data logger)?
- Does the temperature monitoring device have a probe in buffered material?
- Does the temperature monitoring device have a digital display that can be easily read from the outside?
- Is data downloaded and reviewed routinely?
Certificates of Calibration
All units storing VFC vaccines must have a calibrated temperature monitoring device with a current and valid certificate of calibration testing. All certificates must contain:
- Model/Device Name or Number
- Serial Number
- Date of Calibration Testing (Report or Issue Date)
- Instrument Passed testing (Instrument in Tolerance) (Recommended uncertainty = +/-0.5º C (+/-1º F)
VFC providers must have a readily available back-up thermometer with a current and valid certificate of calibration testing. To prevent the certificates of calibration testing of the primary and back-up thermometers from expiring at the same time, the date of calibration testing (or issue date) of the back-up thermometer should be different from the date of calibration testing (or issue date) of the primary thermometer.
The assessor may ask the following questions in regards to certificates of calibration
- Is there a certificate of calibration testing for the temperature monitoring device in this section of the storage unit.
- What is the date of calibration for the temperature monitoring device in this section of the storage unit?
- What is the certificate’s date of expiration based on Immunization Program policy? (See note to reviewer to determine expiration date.)
- Does the certificate contain all the necessary items listed in the Note to Reviewer?
- Who is responsible for supplying the current and valid certificate of calibration for this temperature monitoring device?
- Does the provider have a readily available back-up thermometer with a current and valid certificate of calibration testing?
Probe Placement
“Properly” means that the probe in a commercial or household unit is placed in a central area of the unit directly with the vaccines. Probes should not be placed in the doors, near or against the walls, close to vents, or on the floor of the unit. The only allowable exemption related to this requirement is for providers who have pharmaceutical storage units (built for vaccine storage) that have either: (1) a built-in temperature monitoring device, OR (2) a dedicated port for the probe that dictates the placement of the probe.
Temperature Documentation
Review the temperature documentation over the past three months for this section of the storage unit to determine whether the provider has a process in place for properly documenting temperatures twice a day.
The assessor may ask the following questions in regards to temperature documentation
- Are there two temperature readings recorded for this section of the storage unit per day
- Is there a time, date, and name (or initials) recorded for each reading?
- What is the current temperature and min/max temperatures (if available) in this section of the storage unit?
- Use the reviewer’s thermometer if the provider’s temperature monitoring device does not have a current, valid certificate of calibration testing, or the probe is not properly placed in this section of the storage unit.
- Based on your review of the provider’s recent temperature documentation, including the current temperature, is this section of the storage unit maintaining appropriate temperatures?
Proper Storage Temperatures
Vaccines must be stored under appropriate temperatures as described in the package inserts at all times. Acceptable temperature ranges vary by vaccine type and the range is 36° F and 46° F (2° C and 8° C) and for frozen vaccines the range is -58° F and +5° F (- 50° C and -15° C). Exposure to temperatures outside of those included in the package inserts could affect vaccine viability and, ultimately, could leave children unprotected against vaccine-preventable diseases.
In order to maintain awareness of storage unit temperatures and ensure that vaccines are being stored at appropriate temperatures at all times, VFC providers are required to monitor and document temperatures for all vaccine storage units at least twice a day. Temperature documentation must contain: (1) at least two temperature readings per day, (2) the time and date of each reading and (3) the name (or initials) of the person who assessed and recorded the readings. CDC also recommends that VFC providers record the minimum and maximum temperatures of each unit once each workday (preferably in the morning).
In the event that a temperature excursion(s) occurred in this unit within the last three months, request and review documentation of actions taken to determine whether the provider has a process for properly addressing excursions.
The assessor may ask the following questions in regards to temperature excursions:
- Were vaccines in this unit exposed to out-of-range temperatures in the last three months (including today)?
- Did the provider quarantine and label vaccines as “Do not use”?
- Did the provider place vaccine in a unit where it can be stored under proper conditions, if applicable?
- Did the provider contact the Immunization Program to report the excursion?
- Was the manufacturer contacted for documentation supporting the usability of the vaccine?
The provider must document all excursions and actions taken including the following: (1) Quarantine and label vaccines as “DO NOT USE”; (2) Place vaccines in a unit where they can be stored under proper conditions; (3) Contact the Immunization Program to report an excursion; and (4) Contact the vaccine manufacturer to obtain documentation supporting the usability of the vaccine.
Proper Organization & Storage
Vaccines should be stored in their original manufacturer (or CDC centralized distributor) packaging. They should be placed in the middle of the unit, with space between the vaccines and the side/back of the unit to allow cold air to circulate. 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. Water bottles (for refrigerators) or frozen water bottles (for freezers) should be placed throughout each storage unit in order to: (1) stabilize or extend temperatures during a power outage and (2) to serve as physical blocks preventing the placement of vaccines in areas of the unit that are at higher risk for temperature excursions (such as in doors, vegetable bins, floor, or near/under cooling vents).
The assessor may ask the following questions in regards to the inside of your storage units
- Are vaccines placed in the middle of the unit with space between vaccines and the side/back of the unit to allow cold air to circulate?
- Are vaccines stored in their original packages?
- Are there water bottles (for refrigerators) or frozen water bottles (for freezers) in the unit? If no, confirm it is not recommended by the manufacturer
- Are vaccines stored in the doors, vegetable bins, under or near cooling vents, or on the floor of the unit?
- Is food being stored in the unit?
Protection of Power Sources
VFC providers must take steps to protect the power source for all vaccine storage equipment by means of having clear warning labels on both the plug and the circuit breaker associated with all vaccine storage units. Large hospitals and healthcare systems can meet this requirement by demonstrating that they have comprehensive policies and standard operating procedures to prevent vaccine storage units from being physically disconnected from the power supply. Providers may be asked to demonstrate what measures they take to ensure that vaccine storage units are not accidentally unplugged.
Following CDC guidelines and preparing to answer the questions mentioned above will ensure you are ready for your VFC site visit. Using pharmaceutical-grade refrigerators and freezers can eliminate much of the stress involved in meeting VFC expectations. For specific questions, reach out to your state immunization program.
For a limited time only, Helmer is offering free Certificates of Calibration with new vaccine refrigerator purchases. Learn more by following the link below.
