NUC RAD SHARE

QUALITY CONTROL (Q.C.)

 


N.R.C. REGULATIONS IN NUCLEAR MEDICINE 



 NRC Nuclear Medicine Quality Control Procedures Guidelines Simplified QC regulations and occupational dose limits ALARA program hot lab radiation safety manual NM  Nuclear Regulatory Commission NRC REGULATIONS IN NUCLEAR MEDICINE FOR QUALITY CONTROL AND ASSURANCE

NATURAL BACKGROUND RADIATION

0.3rem or 3mSv per year

~0.01mSv per day

Sources of radiation: Background 50%, medical 48% (CT>NM>IR> Xray/Fluoro), occupational <0.1%.

 

RADIATION DOSES FROM MEDICAL PROCEDURES

Airport security scan 0.001mSv

DEXA 0.01mSv (same as background radiation per day)

Airplane ride 0.005mSv/hr (0.02mSv for 4hr flight)

CXR (2views) 0.1mSv

Mammo (bilateral) 0.8mSv

CT chest (low dose) 2mSv

CT chest (standard) 5mSv

Myocardial Perfusion scan (1day mibi/mibi) 13mSv

Myocardial Perfusion scan (2day mibi/mibi) 20mSv

PET/CT scan 20-30mSv

 

Conversion:

1mSv = 0.1rem  or  1rem = 10mSv

1mSv = 100mrem  or  0.01mrem = 1mSv

1mSv = 100mR  or  1mR = 0.01mSv

1mSv = 10CXR = 100days (3months) of background radiation

 

Dose rate at 1meter for patient after NM procedure:

3mCi Tl-201 = 0.02mR/hr

5mCi Ga-67 = 0.3mR/hr

6mCi In-111 = 2mR/hr

30mCi Tc99m = 2mR/hr

10mCi F-18 FDG = 5mR/hr

30mCi I-131 therapy = 6mR/hr

100mCi I-131 therapy = 20mR/hr

200mCi I-131 therapy = 40mR/hr

 

ANNUAL OCCUPATIONAL DOSE LIMITS

Adult WB (TEDE)

(TEDE=total body exposure from sum of external/DDE and internal dose/CDE to individual organs other than lens of eye)

5rem (50mSv) annual

 

EDE = DDE (collar badge) x 0.3

 

EDE = DDE (waist badge under apron) x 0.15 + DDE (collar badge outside apron) x 0.04

Adult Lens Eye (LDE)

15rem (150mSv) annual

Adult organ (DDE+CDE)/ skin or extremities (SDE from ring badge)

50mSv (500mSv) annual

Embryo/fetus of declared pregnant worker

(written declaration required)

0.5rem (5mSv) over 9 months (≤0.05rem or 0.5mSv per month).

If by time of declaration, dose to fetus has exceeded 0.45rem, OK as long as additional dose to fetus is ≤0.05rem (0.5mSv) for remainder of pregnancy.

Minor worker (<18yo)

0.5rem (5mSv) annual

Negligible dose

0.001 rem (0.01mSv or 10uSv) annual

BEIR VII report (2005)

Less than 100mSv is considered low dose exposure.

>100mSv exposure, get 1 case of radiation induced cancer over background of 42 cases out of 100 people (1% increased risk).

NRCP recommendation

Cumulative lifetime dose for rad worker should not exceed 10mSv (1rem) x age in yrs.

 

1Sv for 100yo

Wt = Tissue weighting factor

(for effective dose and stochastic effects like CA)

High risk (0.12)=breast, BM, lung, intestine (except eso).

Mod high risk (0.08)=gonads.

Mod risk (0.05)=thyroid, bladder.

Low risk (0.01)= bone, skin, brain.

 

ANNUAL DOSE LIMIT TO MEMBER OF PUBLIC

0.1rem (1mSv) annual (this does not include background radiation, medical treatment, research, or exposure from released patient).

 

<0.02mSv (<2mR) integrated dose over 1hr.

 

UNRESTRICTED AREA

Dose from external source to not exceed <2mR integrated dose in 1hr (<0.02mSv in 1hr)

 

RESTRICTED AREA

Dose from external source may exceed >2mR in 1hr (>0.02mSv in 1hr).

Exposure to radiation dose >10% of occ dose limits (>0.5rem or 5mSv).

 

“RADIATION AREA” SIGN

Dose from external source may exceed >5mR or 0.05mSv (but <100mR)  in 1hr at 30cm or 0.3m (used for therapy room)

 

“CAUTION, RADIOACTIVE MATERIAL” SIGN

Area or room where 10 times the quantity of licensed material specified in Appendix C of 10 CFR Part 20 is used/stored (i.e. >10mCi Tc-99m,  >10uCi I-131, >10mCi F-18 etc).

Used thru-out NM department (hot lab, injection room, stress lab, imaging room)

 

DOSIMETRIC MONITORING

Provide dosimeters for exposure monitoring if likely to receive > 10% of annual occupation dose limit to whole body (i.e. >0.5rem or 5mSv).

Annual occ dose report if exposure >0.1rem (1mSv) TEDE or >0.1rem (1mSv) organ or upon worker’s request.  

 

Ring badge given if likely dose to hands >10% of annual occupation dose limit to extremity (i.e >5rem or 50mSv).

 

Notify NRC immediately if exposure exceeds by 5x annual limit.

Notify NRC within 24hrs if exposure exceeds by 1x annual limit.

 

ANNUAL ALARA SAFETY TRAINING

Provided to all who are likely to receive >0.1rem or 1mSv

 

ALARA LEVEL I TRIGGER

Usually >10% of annual occupational dose limit (i.e. 0.5rem or 500mrem WB; 1.5rem eye; 5rem skin)

 

ALARA LEVEL II TRIGGER

Usually >30% of annual occupational dose limit (i.e. 1.5rem WB; 4.5rem eye; 15rem skin)

 

RADIATION SAFETY COMMITTEE

Meetings held quarterly (not required for specific license of limited scope)

 

TYPE A PACKAGE EXPOSURE RATE (must open no later than 3hrs after receiving during normal hours or 3hrs beginning next working day if received after-hours; swipe all 6sides >3x sticker size for wipe test) 

GENERAL GUIDELINES

Can use GM or exposure meter.

Swipe external (all 6 sides) and internal area 3x size of radiation label and count in well counter.

Convert CPM to DPM by dividing CPM by efficiency for that radioisotope.

WHITE I (diagnostic doses)

≤0.5mR/hr at surface

Equal to background at 1m

YELLOW II (I131 doses)

≤50mR/hr at surface

T.I. ≤1mR/hr at 1m

YELLOW III (generator)

≤200mR/hr at surface

T.I. ≤10mR/hr at 1m

NOTIFY NRC IF

Surface reading >200mR/hr.

1m reading >10mR/hr.

Wipe test >6600dpm/300cm2 (0.001uCi).

 

D.O.T. PACKAGE SHIPPING

(require training q3yrs for NMT)

EXCEPTED LIMITED QUANTITIES (Type A UN2910 Class7)

<0.5mR/hr at surface (exposure).

<6600dpm/300cm2 (surface wipe).

 

Limited quantity must be less than derived value specified in 49CFR173.435 (use A2 value x 10-3 for solid like Co57 270mCi, and Cs137 16mCi or A2 value x 10-4 for liquid like Tc99m 11mCi, I-131 1.9mCi, F-18 1.6mCi, Mo99 1.6mCi)—if more than 2 isotope use the lower limit.

 

RADIOACTIVE I White (Type A UN2915 Class7)

≤0.5mR/hr (surface exposure).

<6600dpm/300cm2 (surface wipe).

But exceeds limited quantities limits.

 

RADIOACTIVE II Yellow (Type A UN2915 Class7)

>0.5mR/hr but ≤50mR/hr at surface.

T.I. ≤1mR/hr at 1m.

<6600dpm/300cm2 (surface wipe).

 

LOST OR STOLEN RAM

Sealed source inventory performed semiannually.

 

≥10 times quantity specified in Appendix C of 10CFR Part20 (eg Co-57 1mCi, Cs-137 0.1mCi, Tc-99m 10mCi, I-131 0.01mCi, F-18 10mCi)àhave 30d to search for source and if not found, notify NRC within 30d.

 

≥1000 times quantity specified in Appendix C of 10CFR Part20 (eg Tc-99m ≥1Ci or I-131 ≥1mCi) and if person in unrestricted area exposedànotify NRC immediately.

 

Keep receipt on file for any sealed source returned to vendor.

 

WIPE TEST (for removable contamination detection)

 

dpm = (cpm-background)/ efficiency

BASIC REMOVABLE CONTAMINATION GUIDELINE

Perform weekly (count using well counter).

 

Any wipe results >2-3x background is abnormal (no wipe test for Xe-133 gas).

PACKAGES

6600 dpm/300cm2 (3x sticker size)

(2200 dpm/100cm2)

REMOVABLE CONTAMINATION IN

UNRESTRICTED AREA

(i.e. therapy room before release to non-therapy patients)

20 dpm/100cm2 (Ra-226).

200 dpm/100cm2 (I-131, Sr-90).

1000 dpm/100cm2 (other beta).

REMOVABLE CONTAMINATION IN

RESTRICTED AREA

200 dpm/100cm2 (alpha).

2000 dpm/100cm2 (beta & others).

20,000 dpm/100cm2 (Tc-99, Tl-201, Ga-67, Co-57, Cr-51, Hg-197).

FIXED CONTAMINATION

≤2mR/hr at 5cm

LEAK TEST OF SEALED SOURCES 

<0.005uCi (<5nCi), done q6mos

 

AREA SURVEYS (AMBIENT)—

use survey meter (like GM) sensitive enough to detect 0.1mR/hr

UNRESTRICTED AREAS

0.1mR/hr trigger level (suggested)

RESTRICTED AREAS

5mR/hr trigger level (suggested)

BACKGROUND

<0.02mR/hr (<20uR/hr)

0.05mR/hr (50uR/hr) trigger level

 

SPILL PROCEDURE (spill kit)

MINOR SPILL

1.      Notify people in area

2.      Prevent spread

3.      Decontaminate personnel and cleanup

4.      Survey

5.      Give report to RSO

MAJOR SPILL

(Some use 20mR/hr at 1m as rough indicator of major spill)

1.      Clear the area

2.      Prevent spread

3.      Don’t attempt to clean up

4.      Shield the spill and secure the room to prevent entry

5.      Notify RSO for clean up

6.      Decontaminate personnel as necessary

 

MAJOR SPILL CLASSIFICATION

Tc-99m >100mCi

I-131     >1mCi

F-18      >50mCi

 

DURATION OF BREASTFEEDING CESSATION

Tc-99m   24hr

I-131       indefinitely

F-18        8hr (reduce dose to baby from physiologic breast activity)

I-123       2-3d

Ga-67     4wks

In-111    1wk

Tl-201    2wks

 

Cross placenta: I-131, Ga-67, Tl-201, Pertechnetate, Strontium, FDG

 

PATIENT RELEASE CRITERIA

Do patient specific calculation for >33mCi and <220mCi I-131 to ensure <0.5rem dose to adult family members and caregivers or <0.1rem dose to pregnant women, children, or member of public.

 

<7mR/hr for I-131 @1m.

 

For calculations, generally use occupancy factor (E1=first 8hrs and E2=8hrs to total decay) of 0.25 and use residual thyroid uptake fraction (F2) of 5% if uptake is not performed.

 

WRITTEN INSTRUCTIONS

FOR RADIATION SAFETY

(PATIENT RELEASE)

>0.1rem or 1mSv exposure to others

I-131      >7mCi

Sm-153 >140mCi

Not needed for: Y-90, Sr-89, P-32

 

FOR BREASTFEEDING CESSATION

If dose to infant likely exceed 0.1rem or 1mSv:

 

Tc-MIBI       ≥150mCi

Tc-MAA      ≥6.5mCi

Tc-pertech ≥15mCi*

Tc-RBC       ≥150mCi

Tc-MDP      ≥150mCi

Tc-HIDA     ≥150mCi

Tc-SC         ≥35mCi

Tc-MAG3   ≥150mCi

Tc-HMPAO WBC ≥15mCi

I-131           ≥0.002mCi*

I-123           ≥3mCi

Ga-67         ≥0.2mCi*

In-WBC       ≥1mCi

Tl-201         ≥5mCi*

 

*=cross placenta

WRITTEN DIRECTIVE

Written order by A.U. for any therapeutic dose (eg I-131 >30uCi)

 

AIR EMISSION TO ENVIRONMENT

TEDE to member public <0.01rem/yr or 0.1mSv/yr

 

SEWER DISPOSAL CONSTRAINT

TEDE to member of public not greater than 0.1rem or 1mSv

 

HOT SINK

Total annual quantity not to exceed 1Ci of all isotopes under one license

 

BIOASSAY

Assess organ CEDE (internal dose via ingestion or inhalation) for workers likely to receive >10% of ALI (annual limit on intake which would result in 5rem WB or 50rem organ exposure) annually.

 

Ingestion ALI for I-131 is ≤30uCi.

Inhalational ALI for I-131 (liquid) is ≤50uCi (>10% of which is >5uCi in 1yr). DAC (derived air conc) for I-131 is 2.08 x 10-8 uCi/ml.

 

Check laminar hood (exhaust) annually.

 

DAC (derived air conc) that results in intake of one ALI (derived limit of annual intake via ingestion/inhalation for any radiotracer) doing light work in a year (2000hrs)

OCCUPATIONAL INHALATION

1 x 10-4 uCi/ml for Xe-133

(check Xe trap monthly and neg pressure room q6mos)

AIR EFFLUENT

5 x 10-7 uCi/ml for Xe-133

 

DECAY IN STORAGE

(RADIOACTIVE WASTE)

T1/2phy <120d (decay to 10 half lives of longest-lived RAM; segregate by short and long-lived RAM; dispose when reading at surface at or below background; remove/deface any radiation labels)

 

GENERATOR Q.C.

Moly breakthru

(radionuclidic purity)

≤0.15uCi Mo/mCi Tc @ time of administration

Al3+ contamination

(chemical purity per USP)

≤10ug or ppm Al3+ per cc of eluate

H/R Tc or Free Tc

(radiochemical purity per USP)

Labeling efficiency ≥90% (H/R Tc not tested for insoluble RAM like Tc-MAA and Tc-SC) using TLC.

 

Labeling efficiency= 100% - %HR Tc - %Free TC

 

TLC with Acetone/MEK for Free Tc (migrate farther).

TLC with Saline for H/R Tc (does not migrate).

 

GAMMA CAMERA Q.C.

Energy peaking

Daily

Uniformity flood

(~4-100 million counts)

Daily extrinsic (collimator on)—Co sheet source.

Weekly intrinsic (collimator off)—Tc point source 4-5 crystal dia FOV away.

IU or DU ≥5% in general is abnormal (prefer <3% for SPECT).

Spatial resolution/linearity

Weekly (bar phantom)

COR (SPECT)

Monthly (<0.5 pixel for 360deg)

High count flood calibration

(100-200 million counts)

1-6mos

SPECT phantom “Jaszczak”

(system performance=uniformity, contrast, resolution)

Quarterly

Energy resolution, Energy linearity, Count rate response, Sensitivity, etc

Annually

PET Q.C.

Blank scan for uniformity with rod source (sinogram), PMT gain calibration, Detector performance (Energy/Timing/Emission)

Daily (for PET)

Tube warm-up,

Air calibration,

Constancy and accuracy of CT # (body phantom)

Daily (for CT)

Absolute SUV calibration (phantom),

Image registration,

Detector sensitivity calibration (normalization with high count flood)

Monthly/Quarterly

ACR phantom (system performance), Spatial resolution, Count rate response, Sensitivity, etc

 

Annually

DOSE CALIBRATOR Q.C.

Constancy (reliability and stability of day-to-day performance)—check sealed source activity on all setting

Daily (+/-5%)

Linearity (low to hi activity; Tc decaying source vs shield method with lead sleeve attenuation)

Quarterly (+/-10%)

Accuracy (validity over range of energies and isotopes)—2 sources with different energies (like Co-57 and Cs-137 100uCi)

Annually (+/-10%)

Geometry (different containers/volumes)

Installation and after repairs/relocation

 

THYROID PROBE/WELL COUNTER Q.C.

Calibration (high voltage), Background, Constancy/sensitivity (sealed source)

Daily

Chi-square (variation of measurement to assess for reproducibility)

Quarterly

Energy resolution (FWHM),

MDA (min detectable activity)

Annually

Efficiency (NIST traceable standard)

Installation/repair

SURVEY METER Q.C.

Battery check, Background,

Reference source check (constancy)

Daily

Calibration

Annually

 

INTRA-OP PROBE Q.C.

Battery check, Background,

Bias check, Constancy

Daily

DETECTION RANGE

GM COUNTER

up to 100mR/hr

ION CHAMBER

up to 100R/hr

WELL COUNTER

up to 1uCi

DOSE CALIBRATOR

0.01uCi to 100Ci Tc

 

10 CFR (NRC)

PART 19

Notices, instructions, and reports to workers

PART 20 (subparts A-G)

Standards for protection against radiation

 

Subpart A - General Provisions

Subpart B - Radiation Protection Programs

Subpart C - Occupational Dose Limits

Subpart D - Radiation Dose Limits for  Individual Members of the Public

Subpart E - [Reserved]

Subpart F - Surveys and Monitoring

Subpart G - Control of Exposure from Ext Sources in  Restricted Areas

PART 30

Rules for general applicability to domestic licensing of byproduct materials

PART 35 (subparts A-N)

Medical use of byproduct materials (including training/experience requirements)

 

35.100 – use unsealed byproducts for uptake/dilution/excretion studies

35.200 – use unsealed byproducts for imaging/localization studies for which written directive not required

35.300 – use unsealed byproducts for which written directive required

35.392 for ≤33mC I-131 oral

35.394 for >33mCi I-131 oral

35.396 for parenteral admin of unsealed byproducts requiring written directive

35.1000 – other medical use of byproduct material (e.g. SIR-sphere therapy etc) 

 

313A (AUD) – general NM w/o therapies (35.100 and 35.200)

313A (AUT) – all therapies including Ra-223 (35.300)

 

MEDICAL EVENT

Misadministration (wrong RP, wrong pt, wrong route, dose outside range) or leaking sealed source resulting in ≥5rem TEDE or ≥50rem organ exposure.

 

Also applies to misadministration resulting in fetal dose >5rem or to breast fed child >5rem TEDE or resulting in unintentional permanent functional damage to an organ needs to be reported to NRC.

 

Notify NRC by phone within 24hrs of discovery and in writing by 15d. Also need to notify referring physician and patient within 24hrs.

 

DOSING

DIAGNOSTIC DOSE

+/-20% NRC

THERAPEUTIC DOSE

+/10%

 

LETHAL DOSE

NO DETERMINISTIC EFFECT

<100 rad or cGy (<1 Gy or <1000mSv).

 

2Gy (2000mSv) for transient erythema (skin).

 

Acute Radiation Syndrome (ARS):

2-4Gy = mild

4-6Gy = Hematopoietic (BM)

6-10Gy = GI

>10Gy = Neuro

 

Time to onset of vomiting:

<1hour= >6Gy

1-4hours= 2-6Gy

>4hours= <2Gy

 

Serial absolute Lymphocyte counts at baseline and 48hrs

LD 50/30 (50% dead in 30d)

400 rad or cGy (4 Gy or 4000mSv)

LD 100/30 (100% dead in 30d)

600 rad or cGy (6 Gy or 6000mSv)

(up to 8 Gy with high-level medical intervention)

 

FETAL DOSE

Risk of Teratogenic effects

 

 

Non-stochastic effects (like microcephaly, growth retardation, MR etc) seen between 2 to 15week gestation (organogenesis) and unlikely below 5rad or 50mSv.

 

Termination of pregnancy advisable if fetal dose over 10 rad (100mGy or 100mSv).

 

Risk of carcinogenesis

 

Baseline risk of childhood CA = 19/10,000.

 

Excess risk of childhood CA per 1rad (10mSv) cof WB dose = 6/10,000.

 

Relative risk of childhood CA double with 5rad (50mSv) WB dose.

 

I-131 therapy

Fetus thyroid begin >8-10wks gestation so if pregnancy discovered within 12hrs of I-131 administeredàgive 130mg KI to mother to partially block fetal thyroid

 

CT imaging

Should obtain consent (especially for CT abdomen/pelvis).

 

IV contrast is relatively safe in pregnancy (no risk of neonatal hypothyroidism with non-ionic contrast).

 

Pump and dump x24hrs if IV contrast given during lactation.

 

MR imaging

Should obtain consent.

 

OK in first trimester (but some suggest delaying until second trimester if possible).

 

IV gadolinium is considered unsafe (FDA category C)—only to be used if absolutely necessary preferably beyond first trimester.

 

Pump and dump x24hrs if IV gadolinium given during lactation.

 

RECORD KEEPING

3yrs is a general rule of thumb.

5yrs for misadministration records, sealed source inventory/leak tests. Indefinite for records of individual dose monitoring, waste disposal records, and RSM meeting minutes (need to keep until termination of license).

 

REACTOR PRODUCED RAM

Mo-99, I-131, Xe-133 (B-)

Sm-153, Sr-89, P-32, Y-90, Lu-177 (B-)

Cs-137 (B-)

Ra-223 (A)

 

CYCLOTRON PRODUCED RAM

F-18, C-11, N-13, O-15 (B+)

Sr-82àRb-82, Ge-68àGa-68 (B+)

In-111, Ga-67, Tl-201 (all EC)

I-123 (EC)

Co-57 (EC)

 

 


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RADIOPHARMACEUTICAL CHART


General nuclear medicine SPECT imaging guidelines bone scan VQ HIDA gallium ga67 indium in-111 WBC octreoscan MIBG I-123 I-131            

  

Radiopharmaceutical imaging delay



RADIATION DOSE FROM COMMON NM STUDIES


ESTIMATED EFFECTIVE DOSE (EDE) OR RADIATION DOSE IN mSv FROM COMMON N

NUCLEAR MEDICINE

IMAGING STUDY

EFFECTIVE DOSE (mSv)

Bone scan (Tc-MDP/HDP)

4-6

Brain scan (Tc-HMPAO/ECD)

7-10

Cardiac scan (1day Tc-mibi rest/stress)

13

Cardiac scan (2day Tc-mibi stress/rest)

20

Cardiac scan (Tc-mibi stress only)

10

Cardiac scan (Thallium)

18-24

Cardiac scan (Thallium/mibi)

27

Cardiac scan (Rb-82 PET)

7

Cardiac scan (F-18 viability PET)

5

Liver scan (HIDA)

3-4

Lung scan (VQ)

11

Gastric emptying (solid)

0.1

GI bleed (Tc-RBC)

4-8

Thyroid scan (I-123)

2-3

Parathyroid scan (Tc-mibi)

7-8

MUGA

5-7

Renal scan

2-3



   
                    RADIATION DOSE EXAMPLES
                    Airport security scan 0.001mSv                    
                    Background 0.01mSv (daily) or 3mSv (yearly)
                    DEXA 0.01mSv
                    Airplane ride 0.005mSv/hr or 0.02mSv in 4hours
                    CXR (2views) 0.1mSv                   
                    Mammogram (bilateral) 0.8mSv
                    Low dose CT chest 2mSv
                    Standard CT chest 5mSv 
                    Stochastic effect risk increases >100mSv
                    Deterministic effect threshold 1000mSv or 1Gy

               
                    RADIATION DOSE CONVERSIONS
                   
1mSv = 10 CXR = 100 days or ~3 months of background radiation
                    1mSv = 0.1rem = 100mrem (or 1rem = 10mSv)
                    1Gy = 100rem = 1000mSv
                    1mR/hr = 0.01mSv/hr  (10uR/hr=0.01mR/hr)
                   
                   

Risk of CA from radiation exposure based on age
0.1Gy=100mSv
  G STUDIES SCANS


BREASTFEEDING CESSATION GUIDELINES (NUREG-1556)

 
BREASTFEEDING CESSATION STOPPAGE HOLDING GUIDELINES FOR NUCLEAR MEDICINE EXAM STUDIES


PATIENT RELEASE CRITERIA (NUREG-1556)

 

Patient release criteria for after I-131 therapy cancer hyperthyhroidism When is it ok to release patient to home after radioiodine therapy 


WRITTEN INSTRUCTIONS REQUIREMENT (NUREG-1556)

  
Written instructions for radiation safety after I-131 radiododine therapy for hyperthyroidism or thyroid cancer