Objectives

The objectives of this audit were to determine if the Department of Health (Department) is ensuring that the registration, licensing, and inspection of radioactive materials facilities and radiation equipment facilities are completed as required. The audit covered licensing and inspection records for the period of January 1, 2017 through February 28, 2020 and other information through March 5, 2021.

About the Program

When handled correctly, radioactive materials have many beneficial medical, industrial, and academic uses. Radioactive materials can be used for diagnostic and therapeutic purposes, to test new drugs and to study cellular functions, and in various industrial applications to protect food and blood supplies, increase the safety of roads and buildings, and locate new energy sources. However, high amounts of radiation exposure can cause serious bodily harm.

The Department is responsible for the supervision and regulation of radiation and radioactive materials in New York State, outside of New York City. To fulfill these responsibilities, the Department has established the Bureau of Environmental Radiation Protection, whose duties include licensing and inspecting approximately 1,100 radioactive materials facilities (RAM facilities), as well as registering and inspecting approximately 9,900 radiation equipment facilities that use diagnostic, mammography, and stereotactic equipment. Failure to promptly register, license, inspect, or follow up on facilities that use radioactive materials or radiation equipment increases the risk that radioactive materials or equipment may be improperly handled or stored, and may expose employees, patients, and others to increased levels of radiation.

Key Findings

• The Department completed 94% of RAM facility and radiation equipment facility inspections on time; however, it completed 44% of those inspections beyond the established 1- to 5-year inspection time frames by relying on a buffer. The buffer is intended to allow for more flexibility and logical extensions to the inspection intervals, such as for staff time and travel. Additionally:
  • Of the 259 RAM facility inspections that needed the buffer to be considered inspected on time, 86 (33%) showed facilities were, at the time of inspection, not in compliance with established standards. Further, for 33 of those 86 inspections (38%), our analysis showed that, during the prior inspection, the Department had also found the facility was not in compliance.
  • Of the 2,720 radiation equipment facility inspections that needed the buffer to be considered inspected on time, 249 (9%) showed facilities were, at the time of inspection, not in compliance with established standards. Further, for 55 of those 249 inspections (22%), our analysis showed that, during the prior inspection, the facility was found not in compliance at that time as well.

Recurring and timely inspections help to ensure sustained regulatory compliance and help address risky situations that could compromise health and safety standards. Instances of non-compliance and repeat non-compliance raise a greater concern about the Department’s reliance on the buffer.

• The Department did not complete all license actions within the Department’s 1-year benchmark. For example, as of July 20, 2020, the Department had not completed 55 licensing actions that were beyond the 1-year benchmark. This could potentially jeopardize the quality of the Department’s licensing program, which can have a direct bearing on public health and safety, as well as security.

Key Recommendations

• Ensure that all required inspections are completed on time.
• Continue to work toward reducing the backlog of pending licensing actions and ensure that future licensing actions are completed within their established benchmark.