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

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