Regulatory Frameworks & Compliance Flashcards

Which federal agency is primarily responsible for regulating radiation-producing X-ray equipment standards in the United States?

Answer: FDA Center for Devices and Radiological Health (CDRH)

The FDA's Center for Devices and Radiological Health (CDRH) regulates the performance standards for radiation-producing electronic products, including diagnostic X-ray equipment, under 21 CFR Part 1020.

The NCRP recommended annual effective dose limit for occupationally exposed workers is:

Answer: 50 mSv

The NCRP recommends an annual effective dose limit of 50 mSv (5 rem) for occupationally exposed workers, with a lifetime cumulative limit of 10 mSv × age (in years). This is consistent with NRC and EPA regulations.

Under the ALARA principle, a radiographer's personal dosimeter reading for the month is higher than average. The first step is to:

Answer: Investigate the cause of the elevated reading and implement corrective measures

An above-average dosimeter reading triggers an ALARA investigation — identifying the source of extra exposure (technique, positioning, shielding) and implementing corrective measures to reduce future exposure.

Radiographic records, including examination reports and images, must typically be retained for how long according to most state regulations?

Answer: 7 years (or until age of majority for minors)

Most state regulations require radiographic records to be retained for a minimum of 7 years (often longer for pediatric patients — until they reach the age of majority). Specific requirements vary by state.

A facility's radiation protection program must include a written policy for:

Answer: Monitoring occupational dose and reporting to the radiation safety officer

Regulatory requirements mandate that facilities with radiation-producing equipment have written policies for monitoring occupational doses, investigating elevated readings, maintaining records, and reporting to the radiation safety officer (RSO).

Which of the following actions is required when a pregnant radiographer declares her pregnancy to the employer?

Answer: A supplemental fetal dose monitor must be provided and dose management strategies discussed

Upon voluntary declaration of pregnancy, the facility must provide a fetal dosimeter (worn at the abdomen under the lead apron), discuss the 5 mSv dose limit for the gestational period, and review applicable work assignments to keep fetal dose ALARA.