Are You in Compliance with the New VFC Requirements?
As we move into the new year, physicians who are approved with the Vaccine for Children Program to administer federally funded vaccines to eligible children must make sure they are in full compliance with the VFC regulations. Many offices that utilize the New Jersey Immunization Information System (NJIIS) are aware the system has undergone a revamp and that the NJIIS 2.0 launched at the end of January. Along with the upgrades to the NJIIS, effective January 1, 2018, all approved providers must use digital data loggers (DDL) with detachable probes in a buffer material to monitor the temperature of units where VFC vaccines are stored. The DDL should be set to record the temperature at minimum every 30 minutes.
Most importantly, while minimum and maximum temperature readings were previously recommended, effective January 1, 2018, minimum and maximum readings are required and must be entered into the NJIIS. It is very important to make sure that the staff that is responsible for those readings is properly trained. This includes training on the use of the thermometer and understanding that any reading outside the recommended range requires action. Over the last few years, since the recommendation to monitor minimum and maximum temperatures became effective, staff often recorded the out-of-range temperatures, but failed to take the next steps. If staff fails to notify the physician and/or the supervisor, the out-of-range minimum and maximum temperatures may go undetected for prolonged periods of time. These types of misunderstandings can result in an investigation by VFC, a required notification to patients, and restitution by the physician for the cost of vaccines and potential re-vaccination of patients.
The CDC recommended temperature range for refrigerators is 2°C to 8°C (36°F to 46°F), and -50°C to -15°C (-58°F to +5°F) for freezers.
Remember any temperature excursion, regardless of whether it is the current reading or the daily minimum/maximum reading, requires immediate attention and must be reported to the VFC.
If you have any questions concerning this post, please contact Sandra Jarva Weiss, Chair of our Health Care & Life Sciences Practice Group, at sjarvaweiss@norris-law.com.