radiation safety for nuclear medicine – Flashcards

Unlock all answers in this set

Unlock answers
question
The use, purchase, transfer, and disposal of RAM is regulated by which agencies?
answer
NRC State government (Agreement State)
question
What responsibilities does an Agreement State have?
answer
Enforce regulations that are basically equivalent to the NRC (perform inspections, levies fines and citations)
question
Byproduct Material
answer
Any radioactive material yielded or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material
question
Special Nuclear Material
answer
Plutonium Uranium-233 Uranium enriches in 233 or 235
question
Name 2 things that the NRC does NOT regulate
answer
naturally occurring isotopes such as Ra & Rn machine produced radiation (xrays from diagnostic unit or linear accelerator)
question
As of October 2007, name 2 new things that the NRC now regulates
answer
some accelerator produced and cyclotron produced material (Co-57 and F-18)
question
What are the NRC's general duties?
answer
Write standards and rules License users Inspect licensed facilities Enforce regulations
question
Who regulates radioisotopes from accelerator produced sources and from radiation producing machines?
answer
The Dept of Environmental Protection under the Bureau of Radiation Protection
question
How is CFR organized?
answer
Divided into 50 titles Each title is divided into chapters which usually bears the name of the issuing agency Each chapter is divided into parts covering specific regulatory areas
question
The regulations which govern medical use of RAM (byproduct) material are often simply referred to as?
answer
10 CFR (Title 10- Energy, Chapter 1- NRC, Parts 0-199)
question
What is part 19 about?
answer
Notices, instructions, and reports to works: Inspection & Investigations
question
What is part 20 about?
answer
Standards for Protection against radiation
question
What is part 35 about?
answer
Medical use of Byproduct material
question
19.1
answer
Purpose
question
19.2-Scope
answer
Describes who the regulations apply to
question
19.3 Definitions
answer
Working definitions that should be taken literally and are often the difference between compliance and noncompliance
question
19.4 Interpretations
answer
Says that written documentation is required of any interpretation received from the NRC (anything an NRC Rep tells you on the phone isn't binding w/o written documentation)
question
19.5
answer
Communications
question
19.11 Postings of Notices to Workers
answer
The following documents must be posted conspicuously: Parts 19 & 20 CFR NRC License, conditions, and correspondence Specific operating procedures Notice of violation regarding working conditions NRC Form 3 "Notice to Workers" If it isn't realistic to post any of these documents, must have a document saying where all these things can be found
question
How soon should a notice of violation be posted?
answer
within 2 days of receipt, and must remain posted for at least 5 working days or until corrective action is made
question
19.12 instructions to workers
answer
Requirements for instructing workers about radiation safety (topics to be covered, who instruction s/b given, how often)
question
19.13 Notifications and reports to individuals
answer
Licensee must notify each workers of: Exposure data Total annual occupational dose Dosimetry summary for former works Dosimetry info for a worker who exceeds limits Dosimetry summary for worker who is leaving
question
19.14 Presence of Reps of Licensees and Workers During Inspection
answer
Rights of inspectors and licensee employees during inspection: Licensee must allow NRC to look at records, materials, activities Workers can have a rep and a licensee must notify the inspector who it is Worker's rep must be similarly-employed worker The reps can accompany the inspector Consultant of licensee can accompany inspector NRC can refuse accompaniment
question
19.15 Consultation with Workers During Inspection
answer
rights of a worker to privately talk with NRC inspector about regulation related problems
question
19.16. Request by workers for inspection
answer
Allows worker the right to request an NRC inspection
question
19.17 Inspections not warranted, informal review
answer
Just because a worker requests an inspection doesn't mean that it'll happen, describes how an agency will review the reqest
question
19.18 Sequestration of Witnesses and Exclusion of Counsel in Interviews Conducted Under Subpoena
answer
Describes procedures for witnesses to an investigation, how they are sequestered, and their right to have counsel
question
19.20 Employee Protection
answer
"Whistleblower law" Discrimination of an employee who requests an inspection or cooperates with inspection is prohibited
question
19.30 Violations
answer
Describes how NRC enforces regulations
question
19.31 Exemptions
answer
Licensees may request exemption from any rule in part 19
question
19.32 Discrimination
answer
Prohibits job discrimination by a licensee on the basis of gender
question
19.40 Criminal Penalties
answer
States that criminal sanctions can be levied for willful violation, conspiracy to violate, or attempt to violate any regulation
question
What is the Total Effective Dose Equivalent?
answer
TEDE Concerns the whole body limited to 5 rem/year (0.05 Sv)
question
What is Deep Dose Equivalent + Commited Dose Equivalent?
answer
DDE+CDE Concerns any organ or tissue except the eye 50 rem/year
question
What is Lens Dose Equivalent?
answer
LDE Concerns the lens of the eye 15 rem/year
question
What is Shallow Dose Equivalent?
answer
SDE Concerns the skin, extremities 50 rem/year
question
Total Effective Dose Equivalent
answer
Sum of the deep dose equivalent (for EXTERNAL exposures) and the committed effective dose equivalent (for INTERNAL exposures)
question
Deep Dose Equivalent
answer
Applies to whole body external exposure Dose equivalent at a tissue depth of 1 cm
question
What is the 5 rem/year limit based on?
answer
National Council on Radiation Protecction and Measurements (NCRP) Report 116 which basically says that for occupational exposure, the level of protection provided should make sure that stochastic effects are maintained ALARA, and that the risk to an individual of fatal cancer from radiation exposure shouldn't be greater than the # of fatal accidents in safe industries
question
Committed Effective Dose Equivalent
answer
Sum of the products of the weighting factors applicable to each of the body organs or tissues that are irradiated and the committed dose equivalent to these organs or tissues
question
Committed Dose Equivalent
answer
Dose equivalent to organs or tissues of reference (T) that will be received from an intake of radioactive material by an individual during the 50 year period following the intake
question
Lens Dose Equivalent
answer
Applies to external exposure of the lens of the eye and is taken as the dose equivalent at a tissue depth of 0.3 cm
question
Shallow Dose Equivalent
answer
Applies to external exposure of the skin of the whole body or extremity Dose equivalent at tissue depth of 0.007 cm
question
Dose limit to the general public
answer
<0.1 rem (1 mSv)/year
question
The dose limit to the general public dose not include what?
answer
Background radiation Radiation one has received for medical reasons Radiation from a patient containing RAM Radiation received from voluntary participation in medical research project Radiation from waste legally disposed of in the sewer
question
The maximum dose in any one hour in an unrestricted area cannot exceed?
answer
2 mrem (0.02 mSv)
question
Dose limit to occupational workers who are minors
answer
10% of the annual dose limits specified for adult workers, so 0.5 rem TEDE
question
Dose limit to fetus of radiation worker
answer
0.5 rem (5 mSv)
question
The dose equivalent to the fetus is the sum of?
answer
DDE (to woman) + DE to the fetus resulting from radionuclides in the fetus and radionuclides in the declaered pregnant woman
question
What happens if the dose equivalent to the fetus if found to have exceeded 0.5 rem or is within 0.05 rem (0.5 mSv)of this dose by the time the woman declares pregnancy?
answer
She is deemed to be in compliance as long as the additional dose equivalent to the fetus doesn't exceed 0.05 rem during the remainder of the pregnancy
question
Declared Pregnant Woman
answer
A women who has declared she is pregnant voluntarily to the licensee in writing and given the estimated date of conception Declaration is effective until the woman withdraws the declaration in writing or is not longer pregnant
question
What is a "Radiation Area"
answer
Accessible to individuals individual could receive dose equivalent in excess of 0.005 rem (0.05 mSv) in 1 hour at 30 cm from the source or from any surface that the radiation penetrates Requires controlled access
question
High radiation area
answer
Accessible to individuals could result in individual receiving dose equivalent greater than 0.1 rem (1mSv) in 1 hour at 30 cm from the source A licensee must execute controls to either reduce the dose rate, or set off an audible and visual alarm, keep the entrance locked except to authorized persons, provide surveillance
question
Very high radiation area
answer
Grave danger! Accessible to individuals could receive absorbed dose in excess of 500 rads (5 Gy) in 1 hr at 1 meter from the source Controls required
question
Airborne Radioactivity Area
answer
An enclosure which airborne RAM exists in concentrations in excess of the derived air concentrations (DAC) or to such a degree that someone present in the area w/o respiratory protective equipment could exceed (during the hours an individual is present in a week) an intake of 0.6% of the annual limit on intake (ALI) or 12 DAC hours
question
Annual Limit on Intake (ALI)
answer
Derived Limit for the amount of RAM taken into the body of an adult worker by inhalation or ingestion in a year
question
ALI is the smaller value of intake of a given radionuclide in a year by the reference man that would result in a committed effective dose equivalent of?
answer
5 rems (0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual organ or tissue
question
Derived Air Concentration (DAC)
answer
Concentration of a given radionuclide in air that if breathed by the reference man for a working year of 2,000 hours under conditions of light work results in an intake of one ALI
question
All containers that hold licensed material must be labeled how?
answer
"Clearly visible" "Durable" With the radiation symbol and the words "Caution: Radioactive Material"
question
What must the label also contain?
answer
Info about the radioisotope, activity, and date of calibration
question
What must a licensee do to a RAM container if they wish to dispose of it?
answer
Remove and deface the radiation warning label
question
Name the 3 NRC/Agreement State types of licenses for medical use of byproduct material
answer
General License Specific License Specific License of Broad Scope
question
General License
answer
Authorizes physicians/vets/clinical labs/hospitals to receive, acquire, possess, or use small quantities of byproduct material for in vitro for tests not for human administration (must have RSC)
question
Specific License
answer
Authorizes physicians/vets/clinical labs/hospitals to receive, acquire, possess, or use larger quantities of byproduct material for in vitro and in vivo use (administration to humans) (Must have RSC, QMP, etc.)
question
Specific License of Broad Scope
answer
Authorizes use as described in a specific license, plus use of experimental and research material for in vitro, animal, and medical procedures (teaching, university hospitals)
question
Besides the license name and address, what other things does a specific license contain?
answer
License # & expiration, amendment #, RAM approved for use w/ approved forms of that material, maximum amount a licensee may possess at any one time, authorized uses of RAM, license conditions
question
What do license conditions address?
answer
Policies, procedures, rules specific to the license which may address: sites where material can be used/stored name of RSO and authorized users, the purpose of the materials, medical physicist, possession limits, precautionary measures, transport rules, correspondance
question
How long is a license good for?
answer
5 years
question
Upon application or reapplication of the license, a licensee may also have to submit procedures or statements about which procedures?
answer
Calibrating survey meters and dose calibrator, external monitoring program, RSC, leak testing of sealed sources, safe use of RAM, clean-up of spills, reciving packages, opening RAM packages, multi dose vial use, moly concen, area surveys, waste disposal
question
What dose a new license/annual fee cost for: Hospital (specific medical) Hospital (broad scope med) Nuc Power Plant
answer
4900 29000 5 mil
question
When must a licensee apply for an amendment to the license?
answer
1) before it receives, prepares, or uses byproduct material for a kind of use that is permitted under part 35 but isn't authorized by the license's current conditions 2) Before it permits anyone to work as an authorized user under the license (unless the person meets qualification requirements given in the rules and has been approved by the RSC) 3) Before it changes RSO 4) Before it orders byproduct material in excess of the allowed amount 5) Before it changes the areas of use identified in the license 6) Before revising procedures regarding therapy safety
question
35.14 Notifications
answer
A 30 day notice must be given to the NRC if a licensee adds an authorized user, physicist, nuc pharmacist, or if one of the above d/c duties, address changes, name change, if licensee adds/changes areas of use specified in 35.100 or 35.200
question
According to 35.24, a licensee's management must approve in writing of what 3 things?
answer
1) license amendments and requests 2)new authorized users, med physicists 3) radiation protection program changes that don't require an amendment
question
According to 35.24, a licensee must appoint an RSO who agrees in writing to be responsible for implementing the radiation safety program and must meet the following qualifications:
answer
1) Meet qualifications given in 35.50 2)Can't also be an authorized user except for pd of no more than 60 days 3) Identify problems, provide corrective action, stop unsafe operations, verify corrective action implementations
question
According to 35.24, a licensee must establish a radiation safety committee if the the licensee is authorized for 2+ different types of byproduct material use and the committee must include:
answer
An authorized user of each type of use RSO Rep of nursing service Rep of management who isn't use or AU
question
35.27 Supervision
answer
Outlines controls in place for proper supervision of RAM Users
question
Define written directive
answer
An authorized user's written order for the administration of byproduct material or radiation from byproduct material to a specific pt or human research subject as specified in 35.40
question
According to 35.40, a written directive must be signed & dated by an AU before what?
answer
1)Administration of I-131 NaI greater than 1.11 MBq (30uCi) 2)any therapeutic dosage of unsealed byproduct material or any therapeutic dose of radiation from byproduct material
question
If a patient's condition requires immediate treatment, a verbal order is acceptable, providing that what?
answer
A written directive is prepared within 48 hours after tx
question
For I-131 therapies, the written directive must include what?
answer
Pt name, dose
question
For other RP therapies (samarium, strontium, zevalin) the written directive must include what?
answer
Pt name dose route of administration
question
According to 35.41, the licensee must develop procedures that provide high confidence that:
answer
The pt identity is verified before each administration Each administration follows the written directive Verifies agreement with computer generated tx plan
question
What do 35.50-59 cover?
answer
Training requirements
question
Subpart C (General technical requirements) of 35.60 talk about possession use and calibration of instruments used to measure activity of what?
answer
Unsealed byproduct material
question
When must a dose calibrator be calibrated?
answer
Before first medical use According to manufacturers instructions or nationally recognized standards
question
35.61 Calibration of survey instruments
answer
Survey meters must be calibrated before first use, annually, and after repair Cn/b used if the difference between indicated exposure rate and calculated exposure rate is greater than 20%
question
35.63 Determination of Dosages of Unsealed Byproduct Material for Medical Use
answer
1) Licensee must determine & record activity of doses prior to use 2) Dose determination can be a combination of direct measurement, volumetric measurements, and math calculations 3) Can't use dose that differs from the expected dose by >20%
question
35.65 Authorization for Calibration, Transmission, and Reference sources
answer
Allows licensees to possess sealed sources for daily calibration, instrument checks, and no source can be greater than 30 mCi except for tech which can be as much as you need
question
35.67 Requirements to Possession of Sealed Sources and Brachytherapy sources
answer
1)Licensees who possess sealed sources must follow safety instructions by manufacturer 2) test source for leakage every 6 mo 3) conduct semi-annual inventory
question
35.69 Labeling of Vials and syringes
answer
Syringes and vials must be labeled to identify the RAM and/or drug
question
35.70 Surveys of ambient radiation exposure rate
answer
at the end of each day of use, licensee must survey with a survey meter anywhere unsealed byproduct material was prepared for use or administered
question
35.75 Release of Individuals Containing Unsealed Byproduct Material or Implants Containing Byproduct Material
answer
1) Licensee may release an pt who has unsealed byproduct material/implants if the total effective dose equivalent to any other individual from exposure to this person won't exceed 5 mSv (500 mrem) 2) Licensee must provide the released individual with instructions to maintain ALARA if the total effective dose to another individual is likely to exceed 1 mSv (100 mrem) 3)Must keep record of the justification of release of patients
question
35.92 Decay in storage
answer
Byproduct material can be held with a half life of less than 120 days for decay in storage and may be disposed of when it measures background and when the radiation labels are 0bliterated
question
35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive isn't required
answer
Byproduct material can be used for uptake, dilution, and excretion studies if the material is provided by a licensed manufacturer, ANP, or NRC research facility
question
35.190 Training for Uptake, Dilution, and Excretion studies
answer
Training requirements for authorized users who wish to perform 35.100 studies
question
35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive isn't required
answer
Unsealed byproduct material for imaging and localization can be used if the material is from a licensed manufacturer, ANP or NRC facility
question
35.204 Permissible moly concentration
answer
Can't exceed 0.15 uCi Mo/1 mCi tech before administering to pt
question
35.290 Training for imaging and localization studies
answer
Education and training experience for a physician who wishes to be listed as an AU on the license to perform imaging and localization studies with RP's covered by section 35.200
question
35.300 Use of unsealed byproduct material for which a written directive is required
answer
Unsealed byproduct material c/b used for diagnostic or therapeutic studies if the material is from a licensed manufacturer, ANP, or NRC facility
question
35.310 Safety Instruction
answer
Radiation safety s/b provided initially and at least annually to all ppl caring for patients that have received quantities of byproduct material that requires a written directive
question
35.310-Describe the topics that the safety training must cover
answer
Patient control (restrictions) Visitor control (restrictions) Contamination control Waste control Notification of RSO if emergency or patient dies
question
35.315- Safety Precautions
answer
If a patient receiving byproduct material requiring a written directive can't be released: Patient must be quartered in private room Visibly post "Caution: RAM" sign Note the visitation restrictions on the door monitor material removed from pt room or handle the material as radioactive waste Notify RSO if pt dies or emergency
question
35.390 Training for use of unsealed byproduct material for which a written directive is required
answer
Education and training requirements for physician who wishes to be AU on license to order, use and administer RP's covered by 35.300 (training requirements are heightened for this user)
question
35.932 Training for Tx of Hyperthyroidism
answer
Direct supervision of at least 10 cases
question
35.934 Training for Tx of Thyroid Carcinoma
answer
Direct supervision of at least 3 cases
question
Medical Event
answer
An even that results in a dose that differs from the prescribed dose by more than 5 rem effective dose equivalent, 50 rem to an organ or tissue, or 50 rem shallow dose equivalent to the skin, AND: the delivered dose differs by 20%, or the fractionated dose delviered differs from the prescribed, for a single fraction, by >50%
question
Medical Event (contd)
answer
A dose that exceeds 5 rem effective dose equivalent, 50 rem to organ/tissue, 50 rem shallow dose equivalent to the skin for any reason: Wrong radioactive drug administered, wrong route of administration, administration of dose to wrong individual, administration delivered by wrong mode of tx, leaking sealed source
question
Medical Event (contd)
answer
Dose to skin or organ or tissue other than tx site that exceeds 50 rem to organ or tissue and >50% of the dose expected from the administration defined in the written directive
question
When must a licensee report a medical event to the NRC?
answer
No later than the next calendar day after discovery and by written report within 15 days of discovery Licensee must notify the individual and his/her referring physician within 24 hours after discovery
Get an explanation on any task
Get unstuck with the help of our AI assistant in seconds
New