NRC Regulations, Radiation Areas, and Safety Procedures in Nuclear Medicine

Agreement States

Regulated by the State (keeping within federal guidelines of the NRC)

Non-agreement States

Regulated by the NRC directly

NRC form 3

Must be posted in an area accessible by all employees ( 'NOTICE TO EMPLOYEES')

10 CFR 32

Specific domestic licenses to manufactures or transfer certain containing byproduct material

10 CFR 30

Rules applicable to licensing of byproduct materials

10 CFR 35 D-H

Part of the 'medical use of radiation' statute dealing with authorized users

10 CFR 19

Notices, instructions, report to workers, inspection, and investigation

10 CFR 110

Export and Import of nuclear equipment and material

10 CFR 35

Medical uses of radiation

10 CFR 20

Standards for radiation protection

49 CFR Part 100 - 500

Regulations pertaining to commercial transport of radioactive materials

Misadministration - Diagnostic - I-131 or I-125

>30uCi, Dose Difference ±>20%, Wrong Patient, or Wrong Radiopharm

Misadministration - Diagnostic - Other RPx's

Wrong Patient, Wrong Radiopharm, Wrong Route, Wrong Dose ±>20%, & deep dose >5 rem or total organ dose >50 rem

Misadministration - Therapeutic

Wrong Patient, Wrong Radiopharm, Wrong Route, Wrong Dose >20%

Recordable Event - Diagnostic

I-131 or I-125 : >30uCi, No Written Directive, No Record, & Dose Differs by 10%

Recordable Event - Therapeutic

No Written Directive, No Record, & Dose Differs by 10%

Reportable Event

All misadministrations are reportable events

Reportable event - Notifications Within 24 hours

Call radiation safety officer, referring physician, and NRC

Reportable event - Notification within 15 days

Within 15 days: Written report to NRC, referring physician, and patient

Reportable event - Record kept

5 years

Reportable event Quality Management Program

describes actions taken to prevent recurrence and its procedures for prescribing, calculating, dispensing, verifying, and administering radiopharmaceuticals (revised every 12 months)

Unrestricted Areas

No posting needed; Likely dose cannot exceed normal public dose < 2 mRem/hr, < 100 mRem per 7 consecutive days

Restricted Areas

> 2 mRem/hr; Radioactive materials received, prepared, used, & stored

Caution Radioactive Materials

Radioactive materials stored

Caution Radiation Area Keep Out

> 5 mRem/hr at 30 cm; Must secure all radioactive material and provide sign

Caution High Radiation Area

> 100 mRem/hr

Dose Limits - General Public

0.1 rem / year (2% of occupational dose);

0.02 rem / hour

Dose Limits - Occupational

Whole Body: < 5 rem;

Eyes: < 15 rem;

Extremity: < 50 rem;

Organ: < 50 rem

Dose Limits - Pregnant Worker

0.5 rem / entire pregnancy (0.05 rem / month)

Expected natural background

0.3 rem / year

Personal monitoring

> 10% annual limit; Declared pregnancy to receive > 0.1 rem

Major Spills - Tc99m

100 mCi

Major Spills - Tl-201

100 mCi

Major Spills - Ga 67

10 mCi

Major Spills - In-111

10 mCi

Major Spills - I-131

1 mCi

Minor spills procedure

Notify personnel, cover with absorbent paper, use protection, clean up, all contaminants in labeled bag, place in waste container for 10 half lifes

Clean spills until <200 dpm/100cm^2

ALARA Investigational Levels (NM under level 1)

Total Effective Dose Equivalent (TEDE) 100;

Lens Dose Equivalent (LDE) 300;

Shallow Dose Equivalent (SDE) 400;

Committed Effective Dose Equivalent (CEDE) 400

Packages - White I

Surface: 0.5 mR/hr; 1 Meter: 0

Packages - Yellow II

Surface: 50 mR/hr; 1 Meter: < 1 mR/hr

Packages - Yellow III

Surface: 200 mR/hr; 1 Meter: < 10 mR/hr

Package label requirements

The radionuclide, activity in Bq, and TI in mR/hr

Transport Index

Number on the radioactive label that gives max dose rate @ 1 meter in mR/hr

Receiving a Package - Survey

- Survey within 3 hours

- Don't leave unattended and keep secure

- Inspect package visually

-Monitor surface with GM

-Wipe all sides of package 100cm^2

-If >2200 dpm then rewipe, increase count time, recount bkg

-Inspect and wipe pigs

record package receipt

- Deface labels before trashing

- If package is damage, don't let driver leave and contact RSO

-Receiving measurements should be less than the TI

ALARA

As Low As Reasonable Achievable

Radiation Safety - Time

Reduce time near sources

Radiation Safety - Distance

Increase distance from sources

Radiation Safety - Shielding

Use appropriate shielding when handling radiopharms

Radiation Safety - Radioactivity

Amount of ionizing radiation released and is measured in Ci or Bq

Radiation Safety - Exposure

Amount of photon radiation traveling through the air and is measured in R

Radiation Safety - Absorbed dose

Amount of radiation absorbed by an object/person and measured in r (rad) or Gy

Radiation Safety - Dose Equivalent

Combination of absorbed dose and the biologic effects, measured in rem and Sv

TEDE

Total effective dose equivalent; means the sum of the DDE for external exposures and the CEDE for internal exposures; (DDE + CEDE = TEDE)

DDE

Deep dose equivalent (Hd); applies to external whole body exposure; means the dose equivalent at a tissue depth of 1 centimeter (1,000 mg/cm2)

CEDE

Committed effective dose equivalent (HE,50); is the 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 each of these organs or tissues (HE,50 = S WTHT,50)

Anual Limit on Intake (ALI)

Annual limit on intake; means the derived limit for the amount of radioactive material taken into the body of an adult worker by inhalation or ingestion in a year.

Derived air concentrations (DAC)

Means the concentration of a given radionuclide in air which, if breathed by Reference Man for a working year of 2,000 hours under conditions of light work, results in an intake of one ALI.

Light work conditions

An inhalation rate of 1.2 cubic meters of air per hour for 2,000 hours in a year.

Member of the public

Means any individual except when that individual is receiving an occupational dose.

Licensee's employees as MOPs

Licensee's employees are MOPs when they are not receiving an occupational dose.

Kinetic Energy Released in Matter (KERMA)

Sum of kinetic energies of all the charged particles

Cumulative Lifetime Limit

1 rem x age in years; designed for long term control

Prospective Limit

5 rem / year; designed to restrict dose at early ages and allow flexibility at older ages

Retrospective Limit

3 rem / quarter; designed for Nuclear power plant workers

Stochastic Effects

''chance events"; probability of the effect increasing with dose, but the severity of the effect is independent of the dose received (follows no threshold) ex: cancer

Deterministic Effects

Related directly to the absorbed radiation dose and the severity of the effect increases as the dose increases (typically has a threshold) ex: skin red or hair loss

Direct Effect

Break DNA strands by direct hit (exogenous damage)

Indirect Effect

Chemical bond breakage of DNA strands (endogenous damage)

Hormesis

Hypothesis that low doses of ionizing radiation are beneficial, stimulating the activation of repair mechanisms that protect against disease

Linear Effects

Indicates a proportional relationship to radiation dose

Non-linear Effects

The rate of response changes at different levels of exposure

Threshold

Requires a certain minimum exposure to be manifested (below this is considered safe)

Non-threshold Effects

No required minimum, all exposure is unsafe

Fractionation

Breaking the total delivered dose into several separated portions allowing recovery periods between exposures

RAM

Radioactive material

Dosimetry

Required for those who might reach 10% of an annual limit for whole body or extremity

Ring Dosimeter

On hand facing the palm

Body Dosimeter

Worn between the waist and neck

Fetal Dosimeter

Worn at waist level

Security

Keep hot lab door locked and do not leave any RAM unattended

Ambient survey

Done daily in areas where radioactive materials were used and stored

Wipe tests

Done weekly in areas where radioactive materials were used and stored

Spill Kits

Required in every laboratory

Removable Contamination

Easily removable; continue to clean area until wipe test is below trigger limit (<200dpm/100cm^2)

Fixed Contamination

Cannot remove easily, use survey meter and then cover with lead

Written Directive

Used for: >30mCi of I-131, Y-90 administration, & Ra-223 Xofigo therapy

GM Speed

1 detector width per second

Wipe Test

Make a S shape 100cm^2

R

Rads or Roentgens

Airborne Radioactive Sign

Could exceed in a week = 0.6 % of the annual limit on intake (ALI) or 12 DAC hours

Minimum Detectable Activity

MDA is the smallest amount of activity a system can detect above background (sensitivity)

Endogenous damage

Happens internally from reactions within the cell

Exogenous damage

Caused by an external agent (radiation)

Cell Sensitivity

More prolific = more sensitive; more primitive = more sensitive

Relative Biological Effectiveness (RBE)

Effectiveness of a certain type of radiation in causing a specified effect or disease

Oxygen Enhancement Ratio (OER)

Increased presence of oxygen enhances the production of free radicals and toxins from radiation exposure

Somatic effects

Occur in the exposed person

Genetic effects

Appear in later generations

Early effects from radiation

Occur within hours, days, or a couple weeks

Late effects from radiation

Occur within a couple months or years