What You Should Know as an RSO
This information provides guidance to new Radiation Safety Officers (RSO) in facilities with a radioactive materials license and a nuclear medicine department. Please note that requirements for a Radiation Safety Officer vary by state, and the information in this site, while it may apply to other states, was developed according to regulations in the state of Florida.
10 THINGS AN RSO SHOULD KNOW:
- Radioactive Materials License
- Authorized Users
- Personnel Dosimetry
- Nuclear Medicine Records
- Radiation Safety Committee Meetings
- Pregnant/Nursing Patients
- Pregnant Workers
- Medical Physics Support
1. Radioactive Materials License
The Radioactive Materials License (RML) is issued by the Florida Department of Health’s Bureau of Radiation Control (BRC) and allows Authorized Users (physicians listed on the RML) to supervise the use of radioactive materials. It is issued for 5 years and can be renewed or amended as needed. The original license application is fairly lengthy and the license can sometimes take several months to obtain.
An amendment to the license must be requested if:
- There is a change in RSO.
- There is an Authorized User to be added or deleted.
- There are any changes to rooms in the facility where radioactivity is used or stored.
- There is a significant increase in radioisotope use (beyond what is currently authorized).
- A radiopharmaceutical or use that is not currently on the license is needed (e.g., therapeutic I-131).
The amendment must be received prior to implementing the new use.
2. Authorized Users
The physicians named as Authorized Users on the radioactive materials license have the following responsibilities with regard to the diagnostic and therapeutic use of radioactive materials in humans:
- Making a determination that a nuclear medicine procedure is appropriate.
- Prescribing the radiopharmaceuticals dosage and the route of administration.
- Actual use or direction of licensed nuclear medicine technologists in the use of radioactive material.
- Interpretation of results of diagnostic procedures, and evaluation of their quality.
- Regular review of the progress of patients receiving therapy.
- Provision of follow-up medical care if necessary.
The AU normally satisfies these requirements for diagnostic procedures via a signed Diagnostic Clinical Procedures manual.
3. Personnel Dosimetry
The use of dosimeters (e.g., film badges, OSLD, TLDs, ring badges) on personnel assists the RSO in the evaluation of occupational dose as well as assessing adherence to ALARA principles. It is your duty as the RSO to implement the following standards for your staff’s personal radiation protection.
- Monitoring criteria:
- Occupational dose is limited to 5,000 mrem/year.
- Monitoring is required for workers likely to reach 10% of this limit (500 mrem/year).
- All nuclear medicine technologists must be monitored for both whole body and extremity doses.
- Exposure reports must be reviewed, signed and dated at least quarterly by the RSO, but monthly provides better oversight of doses. These reports should be made available for staff review each month and it is required that a report be provided to each worker annually.
- ALARA principles:
- Keep workers informed and up to date of how to keep their dose “As Low As Reasonably Achievable”.
- Dose can be reduced by using Time, Distance, and Shielding precautions.
- When dosimeter results exceed investigational levels, the RSO needs to take the actions as outlined in the ALARA investigational levels table.
|ALARA Investigational Levels|
ALARA Level I(10% annual limit)
ALARA Level II(30% annual limit)
|Whole Body (DDE)||125 mrem/calendar qtr||375 mrem/calendar qtr|
|Lens of the Eye (LDS)||350 mrem/calendar qtr||1250 mrem/calendar qtr|
|Extremities||1250 mrem/calendar qtr||3750 mrem/calendar qtr|
|Action||RSO should report these cases at the next RSC meeting, and look for trends||RSO must report these cases at the RSC meeting. RSO needs to investigate reason for exceedence, and take action as needed. The minutes of the next RSC meeting must include a review of the findings.|
4. Nuclear Medicine Records
Documentation of any required approvals, incidents, and standard procedures will be useful in keeping the safety program efficient and ready for state inspection. It is important to follow state regulations in regards to medical events and radioactive spill reports.
- Daily patient schedules must be approved by the RSO or AU in order to authorize the administration of radioactive materials to patients (Ref: Diag. Clinical Proc. Manual).
- If license allows for uses of I-131 (as NaI > 30 μCi) or any therapeutic pharmaceuticals (these require written directives), you are required to maintain a Quality Management Program (QMP) and review it at least annually.
- “Medical Event” is a significant error in the administration of a radiopharmaceutical for which a written directive is required. If you believe such a problem has occurred with I-131 or a radiopharmaceutical procedure contact your Medical Physicist for assistance.
- “Recordable Event” is an error of lesser degree also involving the administration of a radiopharmaceutical for which a written directive is required. If you believe such a problem has occurred with I-131 or a radiopharmaceutical procedure contact your Medical Physicist for assistance.
- “Reportable Event” is an error involving the administration of a radiopharmaceutical, for which a written directive is required, resulting in injury to or death of the patient or large unintended doses to the patient. In some cases, these events must be reported within 24 hours.
- Contact Radiation Services, Inc. for assistance when calculating a medical event dose, or differentiating between reportable or recordable events.
- Although not required, it is good practice to sign off on quality control results to show administrative oversight of the program.
5. Radiation Safety Committee Meetings
The Radiation Safety Committee (RSC) oversees the radiation safety program within a hospital and works alongside the RSO to achieve a safe and well-informed environment for both employee and patient.
- Meets at intervals not to exceed six months – quarterly is better.
- Typically includes the RSO, radiology manager, representatives from administration, nuclear medicine, and nursing, the physicist, and others as needed.
- Ensures satisfactory training of all workers using or exposed to radioactive material and reviews personnel dosimetry reports since the previous meeting.
- Ensures safe use of radioactive material. e. Reviews (at least annually):
- Radiation safety program.
- Diagnostic and therapeutic radioactive materials Quality Assurance program.
*Note: Stand-alone clinics are not required to establish an RSC;
Hospitals are required to have an RSC.
6. Pregnant/Nursing Patients
When life-threatening situations occur, and a study involving radiation is deemed necessary for the pregnant mother, then there should be no delay in proceeding with the test. The fetal dose can be determined afterward. With some notable exceptions (radioiodines, others), most diagnostic studies do not expose the fetus to unacceptable high doses. In keeping with the ALARA principle, diagnostic procedures that do not expose the fetus to radiation are preferred (ultrasound, MR, etc.) for pregnant patients.
- All women of childbearing age (based on your institution’s policy) are to be asked if they could possibly be pregnant or are nursing. Patients who cannot confirm that they are not pregnant, should be administered a pregnancy test.
- Patients who are nursing should be advised to stop breastfeeding temporarily (while radioactivity is still present):
- Nursing women are encouraged to pump breast milk prior to the exam, to store (i.e. freeze) for post-exam nursing.
- After diagnostic imaging, breastfeeding should cease for 4 to 24 hours, depending on the radiopharmaceutical.
- Breast milk can be pumped after the exam and stored until adequately decayed.
- Complete cessation is advised for nursing mothers given I-131, I-123, or Ga-67.
- Contact your medical physicists for more detail about how long nursing patients should cease breastfeeding for specific radiopharmaceuticals.
- Non-emergency studies should be cancelled or postponed until pregnancy/nursing has ended.
- Alternative radionuclides with lower probability of crossing the placenta can be suggested for emergency studies.
- If a patient discovers that she was pregnant during a procedure or becomes pregnant soon thereafter, contact Global Physics Solutions, Inc. to have a medical physicist perform a fetal dose calculation.
7. Pregnant Workers
In the event that a female technologist declares that she is pregnant, the RSO must follow necessary precautions to ensure the continuous safety of both her and the developing fetus. The following guidelines must be referred to in such a situation:
- The dose to the waist of an occupationally exposed declared pregnant woman must not exceed 500 mrem over the nine months of gestation (.5 rem/gestational period).
- When the declared pregnant woman wears a leaded apron, she must be provided with a fetal dose badge to be worn at the waist UNDER the apron.
- The allowable occupational dose (normally measured at the collar outside the apron) of declared pregnant woman remains 5 rem per year.
- The declaration of pregnancy must be voluntary and in writing.
- If staffing permits, responsibilities and tasks of pregnant technologists may be modified (ex: no hot lab QC or prep) to reduce exposure.
When a clinical site is getting inspected, it is the RSO’s duty to comply with the inspector’s needs, answer any questions they may have, and to provide any documents or records to him or her as they request. Before, during, and after the inspection it is important to note these facts:
- Inspections occur periodically – normally every 2 to 3 years.
- Inspections are generally unannounced.
- All documents should be well organized, accurate, signed and up-to-date.
- A follow-up letter will be sent from the agency, and you are responsible for replying within 30 days to say how any stated violations have been corrected.
It is important for the RSO to know what the state allows in terms of the use of x-ray within the nuclear medicine department. As new imaging equipment is produced and other imaging modalities begin to enter the nuclear medicine realm, the RSO must note that:
- The radioactive materials license does not cover x-ray machines – they are registered with the BRC.
- If the department possesses a PET/CT or SPECT/CT scanner, the operation of the CT in conjunction with the PET or SPECT is limited to licensed NMT’s who can document manufacturer-specific training on the particular manufacturer and model to be operated.
*Note: If the nuclear medicine technologist is a licensed radiologic technician as well, they are permitted to operate PET/CT and/or SPECT/CT independently.
10. Medical Physics Support
Your medical physicists can support the RSO in several of their obligations including but not limited to:
- Equipment testing.
- Assuring compliance with federal and state regulations.
- Applying for RAM license amendments.
- Attending RSC meetings.
- Radiation safety training of staff and ancillary personnel.
- Answering dosimetry questions.