Radiography Exam Regulatory Frameworks & Compliance 2 — Questions and Answers

Question 1: Which federal agency is primarily responsible for regulating radiation-producing X-ray equipment standards in the United States?

NRC
FDA Center for Devices and Radiological Health (CDRH) (Correct answer)
EPA
OSHA

Correct 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 FDA CDRH enforces the Radiation Control for Health and Safety Act (21 CFR Parts 1000–1050), which sets performance standards for X-ray equipment (collimation, filtration, beam-on indicators, etc.). State radiation control programs enforce these federal standards and add their own regulations for operator licensing, facility registration, and inspection. The NRC regulates radioactive materials (not X-ray machines). OSHA addresses occupational radiation safety, particularly in specific industries.

Question 2: The NCRP recommended annual effective dose limit for occupationally exposed workers is:

1 mSv
5 mSv
50 mSv (Correct answer)
100 mSv

Correct 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.

NCRP Report 116 (and NRC 10 CFR 20) sets the annual occupational effective dose limit at 50 mSv (5 rem). Equivalent dose limits are: lens of the eye 150 mSv, extremities 500 mSv, and skin 500 mSv per year. The cumulative lifetime limit is 10 mSv × age. For comparison, the annual effective dose limit for the general public is 1 mSv (0.1 rem). Embryo/fetus dose limit during occupational exposure is 5 mSv for the entire pregnancy term.

Question 3: Under the ALARA principle, a radiographer's personal dosimeter reading for the month is higher than average. The first step is to:

Replace the dosimeter and continue working as usual
Investigate the cause of the elevated reading and implement corrective measures (Correct answer)
Immediately resign from radiographic duties
Report the reading directly to the NRC

Correct 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.

ALARA (As Low As Reasonably Achievable) is not just a radiation protection principle but a mandated regulatory approach. Elevated personal dose readings trigger an investigation under most facility radiation protection programs. Steps include: reviewing the work tasks performed during the period, checking shielding use and technique factors, identifying any unusual procedures, and implementing corrective actions. If the reading approaches or exceeds the investigational level (often set at 30% of the annual limit), a formal report to the radiation safety officer is required.

Question 4: Radiographic records, including examination reports and images, must typically be retained for how long according to most state regulations?

1 year
3 years
7 years (or until age of majority for minors) (Correct answer)
Indefinitely

Correct 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.

Medical record retention requirements vary by state but commonly require 7 years for adult records and until the patient reaches age 18 plus 7 years (or similar formula) for pediatric records. Federal regulations (Medicare Conditions of Participation) require 5 years minimum. HIPAA does not set specific retention periods but requires secure storage and access controls throughout the retention period. Facilities typically adopt the most stringent applicable standard. Radiographers should follow institutional policy which incorporates state law.

Question 5: A facility's radiation protection program must include a written policy for:

Marketing of radiologic services
Monitoring occupational dose and reporting to the radiation safety officer (Correct answer)
Selecting vendors for X-ray equipment
Designing the hospital cafeteria layout

Correct 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).

NRC regulations (10 CFR 20) and state equivalent rules require facilities to: implement a radiation protection program commensurate with the scope of licensed activities; monitor occupational doses; investigate doses that exceed action levels; maintain dose records; and designate a radiation safety officer. The RSO is responsible for program implementation, staff training, equipment QC oversight, and regulatory compliance. Annual program audits are recommended. The written program must be available for inspection.

Question 6: Which of the following actions is required when a pregnant radiographer declares her pregnancy to the employer?

The radiographer must be immediately reassigned away from all radiation work
A supplemental fetal dose monitor must be provided and dose management strategies discussed (Correct answer)
The pregnancy must be reported to the NRC immediately
The radiographer's certification must be placed on hold

Correct 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.

NRC regulations (10 CFR 20.1208) set a 5 mSv limit for the embryo/fetus during the declared pregnancy period. Upon declaration (which is voluntary and revocable), the facility provides a second dosimeter to be worn at waist level under the lead apron. The RSO reviews the work assignment with the radiographer and discusses dose management options, which may include modified duties (avoiding fluoroscopy, high-dose procedures) or continuing current duties with enhanced monitoring. Automatic reassignment is not required unless dose limits cannot be maintained.

Radiography Exam Regulatory Frameworks & Compliance 2

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