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NRC FORM 313M U.Ss NUCLE AR REGULATORY COMMISSION Approved by OMB

APPLICATION FOR MATERIALS LICENSE - MEDICAL [*,$.'iO 83asu10 CFR 35

|NSTR UCTIONS - Como ete itens t erough x o1 this a an m,t,aiwoistat,an or an wouat.an for aene.ar af a 1,conse Use succienentar snartss

anae necessary 1 tem 26 must te compiered on air wohcat ans and signed Retson one coor Submst ongonas and oar coor of entorewohcaton to : Detector. Other of huclear Materrals S*!*ty and Safeguards. U S Nx tear Requistory Commossoon. Washongton. D C20555. Upon approval of this apohcatnon, the wohcant asll scesse a Matene s L ncense An NRC Matenas loseme os <ssued ongord-r

wce awth the generalrequorements contanned m Totte 10. Code of fedual Reguintoons. Port 30. and 'he L ocenser os subs ct to 49 10.e

Code of Fedwat Regular,ons. Parts 19. 20 and 35 and to hcense for provosson of Tott 10. Cove of Fsdual Requiations. Part 170 Thelicense fee cetepary shouM be stared m Item 26 and the appropnate for encrosed q

1.0. NAME AND MAILING ADDRESS OF APPLICANT (ensDrucon, 1.tx STREET ADDRESS (ES) AT WHICH R ADIOACftNE MATERIALI,rm. ciinic. physic,an, etc) INC LUDE ZIP CODE WILL BE USED (if d,fkrent from 7.a1 INCLUg2iP CODE

Veterans Administration Medical CenterNuclear Medicine Department 31000 Locust Street nReno, Nevada 89520 mTE LEPHONE NO.? ARE A CODE ( )

2. PERSON TO CONTACT REG ARDING TH4S APPLICATION 3. THIS IS AN APPLICATION FOR: (Checa appropnare stem)

= 0 NEW LICENSEJOHN W. HAMLIN, M.D' tA (3 AMENDME N T TO LICE NSE NO.c. $ RE N E W A L O F LIC E NSE N O. 27 l#5I92 OI702 786- 7200 Ex 317TE LEPHONE NC.: ARE A CODE ( 3

4. INDIVIDUAL USE RS (Name inderiduals who will use or directly 5. R ADI ATION SAFETY OF FICER (RSO) (Name of person desepiatedsupervose use of redooactive matenst. Complete Supplements A and 8 as ra<tration safety offace !! other than onder. dust user, evmplete resu-for each Indtvedual, j me of traonrng and unpenenre as m Supperment A /

See Item 8 on page 7 E. Carl Chamberlain(To designate a new RSO, follow the instructionsin Item 8.b. on page 5 of Regulator _y Guide 10.8.)

6. a. RADIOACTIVE MATERIAL FOR MEDICAL USEMAXIMUM MARK MAXIMUM

ITEMS POSSESSION ITEMS POSSESSIONADDITIONAL IT EMS: DE SIRE D LIMITSRADIOACTIVE MATE RI AL DESIRED LIMITS* LIS TED 1N: ..y.' (In maltrcunesi "x" (in mellocunes)

I INE.13I AS IODIDE FOR TRE ATMENT10 CFR 31.11 FOR IN VITRO STUDIES X 10 OF HYPERTHYROIDISM N/A

10 CFR 35.100. SCHEDULE A GROUP i X AS NEE DE D PHOSPHORUS-32 AS SOLUBLE PHOSPH ATEFOR TRE ATMENT OF POLYCYTHEMIA N/AVER A.LEUKEMI A AND BONE MET ASTASES

10 CFR 35.100. SCHEDULE A GROUP H X AS NEE DEDPHOSPHORUS 32 AS COLLOIDAL CHROMICPHOSPHATE FOR INTRACAVITARY TRE AT- N/A

10 CF R 35.100. SCHEDULE A, GROUP lil X 2000 MENT OF M ALIGN ANT E FFUSIONS.

GOLD.198 AS COLLOlD FOR INTRA.CAVITARY TRE ATMENT OF MALIGNANT N!A10 CFR 35.100. SCHEDULE A, GROUP lV X AS NEEDE D E F F USIONS.

IODINE 131 AS IODIDE FOR TRE ATMENT N/A10 CFR 35.100, SCHEDULE A, GROUP v X AS NEEDED OF THYROID CARCINOMA

XENON.133 AS GASOR GASIN SALINE FORN/A10 CFR 35.100. SCHEDULE A. GROUP VI X 400 BLOOD F LOW STUDIES AND PULMON ARY

FUNCTION STUDIES

6.b. RADIOACTIVE MATERI AL FOR USES NOT LISTED IN ITEM 6.a. Israirdsounes un to Jacusas forcahbratnon and reference standards are authorized under Section 35.14(d),10 CFR Part 35, and NEED NO T BE LIS TEOJ

CH E MICA L M AXIMUM NUMBE RE LEMENT AND MASS NUMBER AND/OR OF MILLICURIES EP

PHYSICAL FORM OF E ACH FORM_

Americ'La 241 Sealed Source 14 milli- To be used in SearleAmersham / curies Analytic Model SS-10244Searle Model Anatomical MarkerNo. AMC.24

8507170109 8505075 -01 PDR I O' 'O

DOFDB E_g OFF OFmnCEgpTi ri $$FWUI M M

~

NEC FORM 313M'

!cen--

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INFORMATION REQUIRED FOR ITEMS 7 THROUGH 23 fts*

For items 7 theough 23, check the appropriate box (es) and submit a detailed desaiption of all the requested information. Begineach item on a separate sheet. Identify the item number and the date of the application in the lower right corner of each page. Ifyou indicate that an appendix to the medical licensing guide will be followed, do not submit the pages, but specify the rev' ions

number and date of the referenced guide: Regulatory Guide 10.8 * R ev. Date:

* NOTE: All appendices referenced on this page are based on Regulatory Guide 10.8,R vision 1, and are attached to the application. Some appendices have been slightlymodified to reduce the reculatory burden.

15. GENERAL RULES FOR THE SAFE USE OF7. MEDICAL ISOTOPES COMMITTEE (Page 5) RADIOACTIVE MATERI AL (Check Onel (Page 18)

" ' ' *y w ,~4 % , % am u ma (See Page 5) X

y Duties as in Appendix 8; or Equivalent Rules Attached(Check One)

Equivalent Duties Attached 16. EMERGENCY PROCEDURES (Check Onel(Page 19)

8. TRAINING AND EXPERIENCE (Page 7) XAppendix H Procedures Followed; or

e ---1-- .A 0 N A a , ..A maim C,.A t ,U L L 4. . ,2 i tr y .~ Equivalent Procedures Attached

X 1' ~ ~ ~ '~ ~~ ~' ~

(See Page 7)

Supplement A Attached for RSO. 17. AREA SURVEY PROCEDURES (Check One/(Page 20)

9. INSTRUMENTATION (ChecA One) (Page 8) X Appendix ! Procedures Followed;or

X Appendix C Form Attached;or Equivalent Procedures Attached

List by Name and Model Number 18. WASTE DISPOSAL (Check Onel (Page 21)

10. CALIBRATION OF INSTRUMENTS (Page 9) X Appendix J Form Attached;or

.an e n penroso,oe r n o n _._ oa , m, or < -

X i,,,,, _ ,,...,,(See Page 9) Equivalent Information Attached

Equivalent Procedures Attached;and 19' ( he k Onel age 23)Appendix D Procedures Followed for Dose

X Appendix K Procedures Fallowed;orX Calibrator;or(Check One)

Equivalent Procedures Attached Equivalent Procedures Attached

11. FACILITIES AND EQUIPMENT (Page 14) 20. THERAPEUTIC USE OF SEALED SOURCES (Page 27)

X Description and Diagram Attached X Detailed Information Attached;and

12. PERSONNEL TRAINING PROGRAM (page 15) X Appendix L Procedures Followed;or

X Description of Training Attached Equivalent Procedures Attached

PROCEDURES FOR ORDERING AND RECEIVING PROCEDURES AND PRECAUTIONS FOR USE OFRADIOACTIVE MATERI AL (Page 16) 21. RADIOACTIVE GASES (e.g.. Xenon - 133)

X Detailed information Attached N/A Detailed Information Attached

"PROCEDURES FOR SAFELY OPENING PACKAGES 22* RADIOACTIVE MATERIAL IN ANIMALS

14. CONTAINING RADIOACTIVE MATERIALS(Check Onel (Page 17) N/A Detailed Information Attached

Appendix F Procedures Followed;or23 RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6.bX

Equivalent Procedures Attached N/A Detailed Information Attached

D CC F cW M 313M* Cc0 Page 2y

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24. PE RSONNEL MONITORING DEVICES

SUPP LIE R EXCHANGE FREQUENCYICheck soproprunte boaI

X R.S. Landauer, Jr. & Co. Monthly"'"

e,WHOLEI'DBODY

O T H E R (Speco fyl

F I L A4

''" E" R.S. Landauer, Jr. , & Co. MonthlyX ''

OTHE R (Specityl

F ILM

c. WRIST TLO

OTHE R (Specityl

d. OTHER ISpecityl ALARA PROGRAM

This institution is committed to the ALARA program set forth in Appendix 0, attached tothis application beginning on page 31.

25. FOR PRIVATE PRACTICE APPLICANTS ONLYHOSPIT AL AGREEING TO ACCEPT P ATIENTS CONT AINING H ADtOACTIVE M ATE Hl ALo

h ATT ACH A COPY OF THE AGREE MENT LE T TE RN AME OF HOSPf T ALSIGNE D BY THE HOSPITAL ADMINISTR ATOR

c. WHEN REQUESTING THER APY PROCEDURES.ATT ACH A COPY OF R ADI ATION SAFETY PRECAU.

C# r y STATE ESP CODE TIONS TO DE TAKEN AND LIST AVAll ABLE 4

RADI ATlON DETECTION INSTRUMENTS

26. CERTIFICATEiThis stem mest be completed by apphcan t)

|

The applicant and any of ficial executing this certificate on behalf of the applicant named en item la certif y that this appl Catson is pregurert inconformity with Title 10. Code of F ederal Regulations. Parts 30 and 35, and that all entormation contait ed hereen including any supplementsattachert hereto,is true and correct to the beast of our knowledge and beleef.

b APPLI N T OH CI YING OF F ICI AL (Sognaturel

/O2 d, /) ,,~a LICENSE FE E FtE QUlHED

(See Sectoon 110 31,10 CFR 9701.,

y"Qq g,,,,,g,y nm

HARRL . P0TTER''' "

11) LICENSE FEE CATEGOHY ExemptMEDICAL CENTER DIRECTOR

d [/th LICENSE FEE ENCLOSED. $ ----

N. C FORM 3f 3M (9 8f)' D9

I

|.

PRIVACY ACT STATEMENT

Pursuant to 5 U.S C. 552 ate)(3), enacted mto law by section 3 of the Privacy Act of 1974 (Public Law 93 579), the followmqstatement is furnisned to individuals who supply information to the Nuclear Regulatory Commission on NRC Form 313MThis information is maintained m a system of records designated as NRC-3 and described at 40 F ederal Register 45334(October 1,1975)

1. AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U S C 2111 and 2201(b)L

2. PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staf f pursuant to the criteria set forth in 10 CF RParts 30 36 to determine whether the application meets the requirements of the Atomic Energy Act of 1954,as amended,and the Commission's regulations, for the issuance of a radioactive material hcense or amendment thereof.

3 ROUTINE USES The information may be used. ta) to provide records to State health departments for their informationand use, and (h) to provide information to Federal, State, and local health of ficials and other swssons in the event of incade1t or cuposure, for their information, investigation, and protection of th++ pubhc health and safety The intne mationmay also be disclosed to appropriate Federal, State, and local agencies m the event that the information indicates aviolation or potential violation of law and in the course of an administrative or ludicial proceedsnq in addition, this information may be transferred to an appropriate Feocrat, State, or local agency to the extent relevant and riccessar y fora NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agencyi decision aboutyou A copy of the bcense issued will routinely be placed m the NRC's Pubhc Document Room,1717 H Street, N W ,Washington, D.C.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF NOT PROVIDINGINFORMATION Disclosure of the requested information is voluntary lf the requested information is not furnished,however, the apphcation for radioactive material license, or amendment thereof, will not be processed,

5. SYSTEM MANAGER (S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety, Of fice of Nuclear Mate-rial Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555

N!C FORM 313M19 81)

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RADIATION SAFETY / Medical Isotopes Committee

The membershin of this connittee will consist of at least three members and willinclude:

1. the radiation safety officer;

2. the hospital administrator, or other administrative official directlyresponsible to the hospital adninistrator in the hospital's internalchain of command;

3. a physician * specialist from each department where radioactive materialsare used; and

4. a representative of the hospital's nursing staff.

The names and qualifications of the committee members will be documented in thecommittee's records, will be updated as necessary, and will be available forinspection by the NRC.

*Some departments, such as the nuclear pharmacy, may not be under the supervisionof a physician. In these cases, the supervisory paramedical professional will bea member of the committee.

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APPENDIX B

b MED6 CAL ISOTOPES COMMITTEE *

Responsibility keeping personnel) are properly instructed as requiredby { l9.12 of 10 CFR Part 19.

The committee is responsible for :4. Review and approve all requests for use of radioactive

1. Ensuring that all individuals who work with or in the material within the institution.vicinity of radioactive material have sufficient trainingand experience to enable them to perform their duties 5. Prescribe special conditions that will be required dur-safely and in accordance with NRC regulations and ing a proposed use of radioactive material such asthe conditions of the license. requirements for bioassays, physical examinations of

users, and special monitoring procedures.2. Ensuring that all use of radioactive material is con-

ducted in a safe manner and in accordance with NRC 6. Review the entire radiation safety program at leastregulations and the conditions of the license. annually to determine that all activities are being con-

ducted safely and in accordance with NRC regulationsDuties and the conditions of the license. The review shall

include an examination of alt records, reports from theThe committee shall: radiation safety officer, results of NRC inspection,

written safety procedures, and the adequacy of the1. Be familiar with all pertinent NRC regulations, the institution's management control system.

terms of the license, and information submitted in sup-*port of the request for the license and its amendments. 7 Recommend remalial action to correct any deficiencies

identifi%Iin the radiation safety program.2. Review the training and experience of allindividuals

who use radioactive material (including physicians, 8. Maintain written records of all committee meetings,technologists, physicists, and pharmacists) and deter- actions, recommendations, and decisions,.b mine that their qualifications are sufficient to enablethem to perform their duties safely and in accordance 9 Ensure that the byproduct materiallicense is amended,with NRC regulations and the conditions of thelicense, when necessary. prior to any changes in facilities,

equipment, policies, procedures, and personnel, as3. Establish a program to ensure that allindividuals whose specified in the license.

duties may require them to work in the vicinity ofradioactive material (e.g., nursing, security, and house- Meeting Frequency

The medical isotopes comr.tittee shall meet as often as neces-*

A ruse is es pected in 9si ihes wound thense nho nome.com4 sary to conduct its business but not less than once in eachtion and functions or this commassee. calendar quarter.

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NAME OF AUTHORIZED USER * AtJTHORIZATION

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John W. Hamlin, M.D. Groups I, II, III, IV, V and VI

- In, vitro studies

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i*If you wish to add additional names to the list, follow the instructions in'

* Item 8 on page 4 of Regulatory riuf de 10,8.:

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- APPENDIX C

INSTRUAGENTATION

1. Survey meters

Elscinta. Manufacturer *s name:

Manufacturer's model number : GSM-1

Number ofinstruments available: I*

Minimum range: 0 mR/hr to __ 0. 5 m R/hr

Maximum range: 50 mR/hr to 200 mafhr

b. Manufacturer *s name : Elscint

Manufacturer's model number: GSM-2

Number of instruments available : I

Minimum range : 0 mn/hr to _ 5 mR/hr

Maximum range: 500 m R/hr to 3000 mR/hr.

2. Dose calibrator.

Manufacturer *s name : Capintec (Squibb)

Manufacturer's model number : CRC-17 & CRC-16

2Number of instruments available ;

3. Instruments used for diagnostic procedures

Manufacturer'sType of Instrument Name Model No.Camma Camera Ohio Nuclear Sigma 400Spectroscaler Picker 621929Portable Gamma Camera Siemens 6480Pcrtable Computer ADAC CAM IIComputer ADAC CDS

4 Other (e-3.. liquid scintillation counter, area monitor, velometer)Gamma Well Counter Packard 500CIbrinator Amersham 291001.

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Call 8RATKMI OF SURVEY INSTRUMENTS

Check appropriate items.

X l. Survey instruments will be calibrated at least annually and following repair.

Y 2. Calibration wat be performed at Iwo points on each scale used for radiation protection purposes, i.e.. at least up,

to | R/hr.

The two points wal be approximately 1/3 and 2/3 of full scale. A survey instrument may be considered properlycabbrated when the instrument readings are within 110 percent of the calculated or known values for each pointchecked. Readings within 120 percent are considered acceptable if a calibration chart, graph, or responw factoris prepared, attached to the instrument, and used to interpret readings to within + 10 percent. Also, when higherscales are not checked or calibrated, an appropriate precautionary note will he posted on the instrument.

3. Survey instruments will be calibrated

a. By the manufacturer

b. At the licensee's facility

(!) Calibration sourceRadionuclideManufacturer's nameModel no.Activity in millicunes

orExposure rate at a specified distanceAccuracy*

Traceability to primary standard.

(2) The calibration procedures in Section I of Appendix D will be usedor

(3) The step-by-step procedures, including radiation safety procedures, are attached.

X c. By a consultant or outside firm

(t) Name Health Physics

(2) Location Northbrook. Illinois

(3) Procedures and sources

X have been approved by NRC and are on file in License No._ 12-09160-01

have been approved by an Agreement State.a copy of the Agreement State hcense, theprocedures, and a description of the sources are attached, and the consultant's report willcontain the information on

the attached " Certificate of instrument Calibration."the consultant's reporting form as attached.

are described in the attechment, and the consultant's report will contain the information on

the attached " Certificate of instrument Calibration."-the consultant's reporting form as attached.

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CALIBRATION OF DOSE CALIBRATOR

A. Sources Used for Lincanty Test

(Check as appropriate)

X First elution from new Mo 99/Tc 99m generator

orIf generators are not in use, a source of Tc-99m with

X Other'(specify)_ activity equivalent to the maximum activity assayed toclinical situations will be used.

B. . Sources Used for Instrument Accuracy and Constancy Tests

SuggestedRadionuclide Activity (mCO Activity (mCs) Accuracy

One militcurie or more within i 5%co.57 35

100 microcuries or more within i 5%na-133 o.i.o.5

103 microcuries or more within i 5%cs.137 o.1 0.2

Ra-226 12 N/A N/A

N/A N/A N/A

C. X The proce'dures described in Section 2 of App, ndix D will be used for cahbration of the dose calibrator

or

. Equivalent procedures are attached. ,

<

ro,i6cea m . . ... .,inon .a ro, u ,,fT... ..,,,o,,,...,,,,, . 3, ,,,,,,,,,,i. ,,, ,,,,,,, ,,, ,,, ,,,,.

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APPENDIX D (Continued)

Section 2

METHODS FOR CALIBR ATION OF DOSE CALIBR ATOR*

All radiopharmaceuticals must he assayed for activity to 3. Calculate net activity of each source subtractingan accuracy of 10 percent. The most common instrument for out background level.accompliJting this is an ionization-type dose calibrator. Theinstrument must he checked for accurate operation at the timeof installation and periodically thereafter. 4. For each source, plot net activity versus the day

of the year on semiloc graph paper.

A. Test for the following:5. Los the background levels.

I. Instrument constancy (daily)

2. Instrument accuracy (at installation and annually 6. Indicate the predicted activity of each sourcethereafter) based on decay calculations and the 15 percent

limits on the graph.3. Instrument lineanty (at installation and cpsarterly

thereafter)7. Repeat the procedure used for the Cs-137 source

4. Geometncal variation (at installation) for all the commonly used radionuclide settings.

8. After repair or adjustment of the dose calibrator, repeat 8. Variations greater than 15 percent from the pre-all the appropriate tests listed above (dependent upon dicted activity indicate the need for instrumentthe nature of the repairs). repair or adjustment.

C. Test for Instrument Constancy 9. Investigate higher than normal background levelsto determine their origin and to eliminate them

Instrument constancy means that there is reproduci- if possible by decontamination, relocation, etc.bility, within a stated acceptable degree of precision,in measuring a constant activity over time. Assay atleast one relatively longlived reference source such as D. Inspect the instrument on a quarterly basis to ascertainCs-137, Co-57," or Ra 226". using a reproducible that the measurement chamber liner is in place andgeometry before each day's use of the instrument. that instrument zero is properly set (see manufacturer'sPreferably, at least two reference sources (for enample, instructions).3 5 mCl of Co 57 and 100 200 yCi of Ca 137 or I 2mg Ita 226 (with appropriate decay corrections) will -be alternated each day of use to test the instrument's E. Test of Instrument Linearityperformance over a range of photon energies andsource activities. The linearity of a dose calibrator should he ascertained

over the entire range of activities employed. This test1. Assay each reference source using the appropriate will use a vial of Tc-99m whose activity is equivalent to

instrument setting (i.e., Cs 137 setting for Cs-137). the manimum anticipated activily to be assayed (e.g.,the first elution from a new generator).

2. Measure background level at same instrument set-ting, or check that automatic background sub- 1. Assay the Tc 99m vialin the dose calibrator, andtraction is operating properly when blanks arc subtract background level to obtain net activit)inserted in the calibrator. in millicuries!

Sn ANSI Na2.13 lett."celebreHon and Usese of Dnee centesen, 2. Repeat step I at time intervals of 6,24. 30. and*

lan6aesion chemhwe ree etw Assey et nadieneendna (Asnecteen 48 hours after the initial assay.Nossenal 34enderde Inesitute. Inc., le30 preedwey, New Yoet. N.Y.lee t a).

3. Using the 30$hout activityincasurement as a seart-,,

ca st and na.2:a are nas suhises so Mac e.ceneinsi che enpective ing point, calculate the predicted activities at 0,see openeg coneuswa se demenone 6a regwereswnes fo' 6, 24. and 48 hours using the following table'

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'Asasy Time * fhr/ Correction Factor as in step 1. (Follow good radiation safety prac-tices to avoid contammation and to minimite

0 31.633 radiation exposure.l6 15.853

24 1.995 3. Select one volume as a standard (such as the30 I volume of reference standard used in performmg48 0.126 the test for instrument accuracy), and calculate

the ratio of measured activities for each volumeE;armpIc : If the net activity measured at 30 hours to the reference volume activity. This representswas 15.625 mci, the calculated activities for 6 and the volume correction factor (CF).48 hours would be 15.625 mci x 15.853 = 247.7mci and 15.625 mci z 0.126 = 1.97 mci,respec. Evample: If activities of 2.04, 2.02, and 2.00 mcitively. are measured for 4. 8. and 10 mi volumes and

' 0 "l i' ' h * " I'""'" '" "* ** ''''' d -4 On semi-log corrdinate paper, plot themeasured net activity and the 2.00calculated activity versus time. 4 ml Volume CF = - = 0.98

' 5. The activities plotted should be within 15 percentof the calculated activity if the instrument is 4. Plot the correction factors against the volume onlinear and functioning properly. Errors greater linear graph paper. Use this graph to select thethan 15 percent indicate the need for repair or proper volume correction factors for routineadjustment of the instrument. assay of that radionuclide.

6. Ifinstrument linearity cannot be corrected,it will 5. The true activily of a sample is calculated asbe necessary in routine assays to use either(s)an follows:aliquot of the cluate that can be accurately mea-sured or (b) the graph constructed in step 4 to True Activity = Measured Activity arelate measured activities to calculated activities. Correction Factor

F. Test for Geometrical Variation where the correction factor used is for the samevolume and geometrical configuration as the

! There may be significant geometrical variation in activi- sample measured.ty measured as a function of sample volume orconfigu-ration, depending on the volume and size of theloniza- 6. Similarly, the same activity of Co 57 in a syringe

| tion chamber used in the dose calibrator. The extent may be compared with that of 10 miin a 30-ccof geometrical variation should be ascertained for vial, and a correction factor may be calculated.commonly used radionuclides and appropriate correc-tion factors computedif variations are significant, i.e., 7. It should be noted that differences of 200 percentgreater than 12 percent. (Even though correction fac- in dose calibrator readings between glass andtr.rs may be provided by the manufacturer, the accu- plastic syringes have been observed for I wer-racy of these should be checked.)When available from energy radionuclides such as 1-125, whics. .nouldthe manufacturer, certified data on geometrical varia- be assayed in a dose calibrator only if the reha-tions may be used in lieu of these measurements. bility of such an assay can be established. Glass

tubes and syringes may also vary enough in thick-To measure variation with volume of liquid, a 30-cc ness to cause significant errors m assaying 1125.!

| vial containing 2 mci of Co 57 or ott er appropriate Hence, adequate correction factors must be| radionuclide in a volume of I ml will be used. established.t

i 1. Assay vial at the appropriate instrument setting. An alternative to providmg syrmge cahbration| and subtract background Icvel 'to obtain net factors is to simply assay the stock vial before

activity. and after filling the syringe. The activity in thesyringe is then the difference in the two readings

2. Increase the volume of liquid in the vial in steps (with a volume correction if significant).to 2,4,8,10,20, and 25 mi by adding Ihe appro-priate amount of water or saline. Af ter each addi- G. Test for Instrument Accuracytion, gently shake vial to mix contents and assay

; Check the accuracy of the dose calibrator for severalradionuclides, including CS-137, 0o-57, and Ba 133,

*Assey times should be measured in whole hours and entrection using appropriate reference stJndards whose activities

rectors shouto he used to the third decimal place as indstated, lhe have been Calibrated by comparisons with standardmore recent half-hfe or T /2 = 6.02 hours has been used en calculatsngi

these correction factors. sources that luve been assayut by NBS and doctanented.!

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The activity levels of the reference sources used should ' 4. Itepeat the above steps for other commonly usedapproximate those levels normally encountered in clin- radionuclides for which adequate reference stand-ical use (e.g., Co-57,3 5' millicuries) giving adequate ards are available.attention to source configuration. Identify in yourapplication the three sources that you will use. State 5. Keep a log of thew calibration checks.nuclide, activity, and calibration accuracy. The lower-energy reference standards (Tc-99m, Xe-133,1-125) 6. Calibration checks th.t do not agree withinmust be in vials with the same thickness of glass as the 15 percent indicate that the instrument shouldactual samples to be measured for best accuracy. be repaired or adjusted. If this is not possible, a

calibra' ion factor should be calculated for useduring routine assays of radionuclides.

1. Assay the reference standard in the dose calibra-tor at the apprornate setting, and subtract the 7. At the same time theinstrumentisbeinginitiallybackground level to obtain the net activity. calibrated at the licensee's facility with the refer-

ence standards, place a long lived source in thecalibrator, sei the instrument, in turn, at the vari-

2.- Itc,wat step i fora totalof 3 determinations,and ous radinnuclide settings used (Cs 137,1131average results. Tc49m,1-125, etc.), and record the readings.

Tf.ese values may later be used to check instru-m ent calibration at each setting (after correcting

3. The average activity determined in step 2 should for decay of the long-lived source) without re-agree with the certified activity of the reference quiing more reference stassdards. Keep a los ofsource withm15 percent af ter decay corrections. these initial and subsequent readings.

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|FACILITY DIAGRAM

(Prepare and Attach to Application)

Submit a detailed diagram of the facility, indicating the type, dimensions,position, and thickness of shielding that will be used for:

| a. Use and storage of Tc-99m generators,

b. Storage of radiopharmaceuticals (refrigerated and nonrefrigerated),

Storage of radioactive waste, including decay-in-storage prior to disposalc.as nonradioactive waste. (This area should be large enough to handle anaccumulation of used Tc-99m generators as well as other solid waste. If

this area is located outside your department, describe how the material|

will be secured. Confirm that this area will be surveyed at least weekly.)

d. Preparation and dispensing of Group 1II kit radiopharmaceuticals (e.g. ,lead glass L-block).

Identify adjacent areas across the walls from use and storage locations, andshow that adequate steps have been taken to ensure that radiation levels inunrestricted areas do not exceed the limits specified in paragraph 20.105(b)of 10 CFR Part 20.

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fJo. CD-s N" UH'3-

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E!NK and DECAY RECElV:NG and No. HF-3STORAGE MODULE NO cs.3 | HOLDING f.tODULE . REFRIGERATOR

CEfJERATOR and (AODULESTORAGE PAODULE

Nuclear Medicine' Modular Systems by:

Kewaunee Scientific Equipment Corporatical'

Special Producta DivisionAdrian, Michigan h9221

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WIPE TEST

DATE

1. D0ORWAY FLOORS

A. MAIN 000R

B. HOT LAB

2. INJECTION AREA

A. DRAWER

B. TABLE TOP

C. FLOOR

3. DOSE PREPARATION

A. LEAD SHIELDi

B. SYRINGE SHIELDi

C. SUPPLY DRAWERS

D. DOSE CALIBRATOR

E. HOT SINK

4. CAMERA

CONSOLE TABLE_

5. REFRIGERATOR

A. HANDLE

B. FLOOR

1 IN VITRO AREA

A. LAB BENCH

B. DRAWERS

7. PACKARD

8. RIA SINK

9. BACKGROUND

Li';"4 7051b DATA SHEET * * " - - " " " " " " ' * " " ' " ' * " "

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PERSONNEL TRAlh!NG PROGRAM

I. Individuals who work in or frequent restricted areas will be instructedin the items specified in 10 CFR 19.12 at the time of initial employmentand at least annually thereafter.

This instruction will include:

a. All terms of the license pertinent to radiation safety.

b. Areas where radioactive material is used or stored.

c. Potential hazards associated with radioactive material.

d. Radiological safety procedures appropriate to their respective duties,

e. Pertinent NRC regulations.

f. Rules and regulations of the license.

g. Obligation to report unsafe conditions to the radiation safety officer.

h. Appropriate response to emergencies or unsafe conditions.

i. Right to be informed of their radiation exposure and bioassay results.

j. Locations where the licensee has posted or made available notices, copiesof pertinent regulations, and copies of pertinent licenses and licenseconditions (including applications and applicable correspondence), asrequired by 10 CFR Part 19.

II. Individuals whose duties may require them to work in the vicinity oflicensed material will be informed about radiation hazards and appropriateprecautions at the time of initial employment and at least annually thereafter.,

| This information will be provided initially at hospital employee orientationsessions and annually thereafter at in-service meetings,

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Item 12Page 15

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APPENDIX Ei

PROCEDURES FOR ORDERING AND ACCEPTING DELIVERYOF RADIOACTIVE MATERIAL

,

l

I. The Supervisory Nuclear Medicine Technologist will (l) A written request * will be obtained from the

i place all orders for radioactive materials and will ensure physician who will perform the procedure,

fthat the requested materials and quantities are auth-orized by the license and that possenion limitsare not (2) Persons ordering the materials will refer-exceeded. ence the physician's written request when

placing the order. The physician's requestwill indicate isotope, compound, activity

2. A system for ordering and receiving radioactive mate- levet, etc.rials will be established and maintained. The systemwill consist minimally of the following. (3) The physician's written request will be ref-

ermeed when receiving, opening,or storingthe radioactive material.

a. Ordering of routinely used materialsc. It is essential that written records' be maintained

for all ordering and receipt procedures.(1) Written records that identify the isotope,

compound. activitv levels, and supplier, 3. During normal working hours, carriers will be instructedetc., will be used. In deliver radioactive packages directly to the Nuclear

Medicine Department.

(2) The written records will be referenecd when 4 During off-duty hours, security personnel or otheropening or storing radioactive shipment. designated individuals will accept delivery of radioac-

tive packages in accordance with the procedures out-hned in the sample memorandum below,

*

b. Ordering of specially used materials (e.g., thera- in the case of spect.i orders, the physician's written reev si end

peutic uses) g,,P[,8'[,,'yff, asp,eg,,c |,,co,rd wun t>e rererenced end ahe do.ep e

, , ,,

!t

SAMPLE" MEMOR ANDUMi

MEMORANDUM FOR: Security Personnel

FROM: Hospital Administrator

SUBJECT: RECEIPT OF PACKAGES CONTAINING RADI0 ACTIVE MATERIAL

Any packages containing radioactive material that arrive between 4:30 p.m. and 7 a.m.or on Sundays shall be signed for by the Security Guard on duty and taken imediatelyto the Nuclear Medicine Department. Unlock the door, place the package on top of thecounter immediately to the right of the door, and relock the door. .

|

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If the package is wet or appears to be damaged immediately contact the RadiationSafety Officer. Ask the carrier to remain until it can be dtermined that neither henor the delivery vehicle is contaminated.

ocRADIATION SAFETY OFFICER

c*0FFICE PHONE

c*HOME PHONE

**0n the actual memo that is used, this information will be filled in and updated asneces sa ry.

Item 13Page 16

'_ _ _ _ _ _ _ _ _ _ _ _ _ .

_ _ _ . _ _ _ _ _ _ _ _

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APPENDIX F

PROCEDURES FOR SAFELY OPENING PACKAGESCONTAINING RADIOACTIVE MATERIAL

1. Special requirements will be followed for packages con- (2) Open inner package and verify Ihat con-taining quantities of radioactive material in excess of tents agree with those on packing slip.the Type A quantity limits as specified in paragraphs Compare requisition,* packms shp, and2Q20$(aXI) and (c)(1) of 10CFR Part 20 (more than label on bottic.20 Ci for Mo.99 and Tc-99m). They will be monitored -

for surface contamination and ex ternal radiation levels (3) Check integrity of final source containerwithin 3 hours af ter receipt if received during working (i.e., inspect for breakage of seals or vials,hours or within 18 hours if received after working loss of liquid, and discoloration of pack-hours, in accordance with the requirements of para- aging material).graphs 2Q205(a) through (c). Au shipments of liquidsgreater than exempt quantities will be tested for leak- (4) Check also that shipment does not exceedage. The NRCRegional Office will be notified in accord- possession hmits.ance with the regulationsif removable contamination

2exceeds 0.01 yCi/100 cm or if external radiationlevels exceed 200mR/hr at the package surface or f. Wipe external Surface Of final10 mR/hr at 3 feet (or 1 m). Source container Shield and re-

move wipe to low background2. For all packages, the following additional procedures area. Check wipes with a thin-

for opening packages wiu be carried out; end-window G-M Survey meter,and take precaution against the

a. Put on gloves to prevent hand contamination. Spread Of contamination as" '*

b. Visually inspect package for any sign of damage(e.g., wetness, crushed). If damage is noted, stop g. Monitor the packing material and packages forprocedure and notify Radiation Safety Officer. contamination before discarding.

c. Measure enposure rate at 3 feet (or I m) from (1) If contaminated, treat as radioactive waste.package surface and record, if >10 mR/hr. stopprocedure and notify Radiation Safety Officer. (2) If not contaminated, obliterate radiation

labels before discardmg in regular trash.d. Measure surface exposure rate and record. If

>200 mR/hr, stop procedure and notify RadiationSafety Officer. 3. Maintain records of the results of checking each rockage,

,

jusing " Radioactive Shipment Receipt Record"(see next

e. Open the package with the following precau- page) or a form containing the same information.tionary steps;

(1) Open the outer package (following manu-facturer's directions, if supplied) and *

ta the case or species orders (e.g., therepy doses), eiso enmrereremove packing shp. with physkian's written request.

Item 14Page 17

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.

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APPENDIX G

GENERAL RULES FOR SAFE USE OF RADIOACTIVE MATERIAL

1. Wear laboratory coats or other protective clothing at ity vs. the order written by the physician who will

j all times in areas where radioactive materials are used. perform the procedure.

2. Wear disposable gloves at all times while handling 7 Wear personnel mor itoring devices (film hadge or TLD)at all times while in areas where radioactive materials* radioactive materials.are used or stored. These devices should be worn at

3. Monitor hands and clothing for contamination after chest or waist level. Personnel monitoring devices when

each procedure or before leaving the area. not being worn to monitor occupational esposuresshould be stored in a designated low hackground area.

4. Always use syringe shield; for routine preparation ofpatient doses and administration to patients.except in 8. Wear TLD finger badges during elution of generator and

circumstances such as pediatric cases when their use preparation, assay, and injection of radiopharmaceuti-i

would compromise the patient's well-being. In these cals.

exceptional cases, use other protective methods suchas remote delivery of the dose (e g.. through use of a 9. Dispose of radioactive waste only in specially designated

butterfly valve). and properly shielded receptacles.

5. a. Do not eat, drink, smoke, or apply cosmetics in any 10. Never pipette by mouth,

area where radioactive material is stored or used.II. Survey generator, kit preparation, and injection areas

b. Do not store food. drink, or personal effects with for contamination after each procedure or at the end

radioactive material. of the day. Decontaminate if necessary.

6. a. Assay each patient dose in the dose calibrator prior i 2. Confine radicactive solutions in covered containersto administration. Do not use any doses that differ plainly identified andlabeled with name of ccmpound,from the prescribed done by more than 10 percent. radionuclide. date, activity, and radiation level, if

applicable.

b. For therapeutic doses.also check the patient's name, 13. Always transport radioactive material in shielded!

the radionuclide, the chemical form, and the activ- containers.

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Item 15t

Page 18

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APPENDIX H

EMERGENCY PROCEDURES

3. SHIELD THE SOURCE: If possible, the spill should !

Minw Spills be shielded, but only if it can be done without further

..1. NOTIFY: Notify persons in the area that a spill has contamination or without significantly increasing

your radiation exposure.I occurred,

2. PREVENT TH E SPRE AD : Cover the spill with absorb- 4. CLOSE THE ROOM: Leave the eaom and lock thedoor (s) to prevent entry.

ent paper.

3. CLEAN UP: Use disposable gloves and remote handling 5. CALL FOR llELP: Notify the Radiation Safety Offi-

tongs. Carefully fold the absorbent paper and pad. In- cer immediately.

sert into a plastic bag and dispose ofin the radioactivePERSONNEL DECONTAMINATION: Contaminatedwaste container. Also insert into the plastic bag all other 6.

contaminated materials such as disposable gloves. clothing should be removed and storal for further evalu-ation by the Radiation Safety Officer. If the spillison *

4 SURVEY: With a low-range, thin-window G-M survey the skin, flush thoroughly and then wash'with mihl

meter, check the area around the spill, hands, and soap and lukewarm water.

clothing for contamination.*RADI ATION SAFETY OFFICER:

5. REPORT: Report incident to the Radiation Safety * OFFICE PHONE:*llOME PHONE:Officer.

* ALTERNATE NAMES ANDTELEPilONE NUMBERS1 Major Spills

DESIGNATED BY RADI ATION SAFETY OFFICER.'

1. CLEAR THE AREA: Notify all persons not involved .-

in the spill to vacate the room.

2. PREVENT THE SPREAD: Cover the spill with ebsorb-ent pads, but do not attempt to clean it up. Confinethe tr.ovement of all personnel potentially contami-nated to prevent the spread.

4

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*0n the actual copy that is posted in the nuclear medicine department, this informationwill be filled in and updated as necessary.

Item 16 :!

Page 19

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APPENDIX l

AREA SURVEY PROCEDURES

1. All elution, preparation, and irdection areas wul be 5. A permanent record will be kept of all survey results,surveyed daily with an appropriately low range survey including negative results. The record wdl include ;meter and decontaminated if necesasty.'

- Location, date, and identification of equipmenta.

2. bboratory areas where only small quantities of radio- used, including the serial number and pertinentact;ve material are used (less than 2tIl pCl) will be counting efficiencies.

surveved monthly,b. Name of person conducting the survey.

3. Waste storage areas and all other laboratory areas willbe suiteyed weekly. c. Drawing of area surveyed identifying relevant

features such as active storage areas, active waste

4. - The weekly and monthly surveys will consist of areas,etc.

d. Measured exposure rates, keyed tolocation on the

a. A measurement of radiation levels with a survey drawing (point out rates that require correctivemeter sufficiently sensitive to detect 0.1 mR/hr. action).

h. A series of wipe tests to measure contamination c. Detected contamination levels. keyed to loca-

levels. The method for performing wipe tests will tions on drawing.be sufficiently sensitive to detect 200 dpm per100 cm for the contaminant involved. Wipes of f. Corrective action taken in the case of contamina-2

elution and preparation areas or other "high tion or excessive exposure rates. reduced con-background" areas wul be removed to s low back- tamination levels or exposure rates after correc-ground area for measurement. tive action, and any appropriate comments.

de s.$he ateElon poeroTrinT j 6. Area will be cleaned if the contaminationlevelexceeds" ' '

a e t.s"rvey rows s wm he recorded. 200 dpm/100 cm .

4

Item 17Fage 20

Om Omt-. .

,

APPENDIX J

WASTE DISPOSAL

Note : In view of the recent problems with shallow-land burial sites used by commercial waste dnpoulfirms NRC is encouraging its licensecs to reduce the volume of wastes sent to these facihtics.Important steps in volume reduction are to segregate radioactive from nonradioactive waste, tohold short-lived radioactive waste for decay in storage, and to release certain materials in thesanitary sewer in accordance with 20.303 of 10 CFR Part 20.

l .' Liquid waste will be disposed of(check as appropriate) N/A Disposed of by commercial waste disposal serv-ice (see also item 4 below).

Y . In the sanitary sewer system in accordance withN/A other (specify):$ 20.303 of 10 CFR Part 20.

-Or~N/A sy commercial waste disposal service (see also

item 4 below).* 3. Other solid waste will be (check as appropriate)

X See #3other (specify):X Ileid for decay * until radiation levels, as mea-

sured in a low background area with a low-levelsurvey rneter and with all shieldmg removed. have

2. Mo 99/Tc-99m generators wi!I be(check as appropriate) reached background levels. All radiation labelswdl be removed or obliterated, and the waste

Returned to the manufacturer for disposal. will be disposed of in normal trash.-OT-

|X Held for decay * until radiation leve"Is, as mea- N/A Disposed of by commercial waste disposal serv-sured in a low background area with a low-level ice (see also item 4 below).survey meter and with all shielding removed, havereached background levels All radiation labels Other (specify).will be removed or obliterated, and the generatorswill be disposed of as normal trash.* *

4 The commercial waste disposal service used will be,

Be sure that waste storage areas were described in item II andthat they are surveyed periodically (Item 87). N/A

These generators may contain long4ived radioisotopse contami. (Name) (City, Statelnants. Therefore, the generator columns mit be segregated to thatthey may be monitored separately to ensure decay to bechsenundlevels prior to dispneal. NRC/ Agreement State license No ,N/A

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Item 18 '

Page 21

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.APPENDIX K*

R ADIATION SAFETY PROCEDURES FORTHERAPEUTIC USE OF R ADIOPHARMACEUTICALS*

b 1. All patients treated with I-131 or Au-198 will be placed 8. Nondisposable items used for these patients will be held

in a private room that has a toilet.The large surfacesin plastic bassin the patient's room and willbe checkedfor contsmination by the Radiation Safety Officer or

in the room and todet areas that are more likely to be his designee. Items may be returned for normal use,contaminated will be covered with absorbent pads or held for decay, or decontaminated, as appropriate.protective material as appropriate to the amounts ofccmtemination to be expected. Attention should be If urine and vomitus from 1131 therapy patients are9.given to objects hkely to be touched by the patient. collected, they will be stored for decay in the radioac-eg., telephones, doorknobs, and other items that would tive waste storage area. Such stored wastes will be re-be difficult to decontaminate. Plastic bags or wrappings

tained until they have reached background levels, asthat are waterproof and easily disposable should be measured with slow-levelsurvey meter They willthenused on the smaller items. be released to the sanitary sewer system.

2. The patient's room will be properly posted or attended Before a therapy patient's room is reassigned to anotherin accordance with {{20.203 or 20.204 of 10 CFR 10.

patient, the room will be surveyed for contammationPart 20. and decontaminated if necessary, and all radioactive

waste and waste containers will be removed,3 Surveys of the patient's room and surrounding areas

will be conducted as soon as practicable af ter adminittra: ion of the treatment dose. Exposure rates will be 11. Nursing instructions

measured at the patient's bedside and 3 feet (or i mi Nurses should spend only that amount of timefrom the patient after administration and at the entrance near the patient required for ordinary nursing

a.

to the room. The Radiation Safety Officer or his desig-nee will then determine how long a person may remain care. Special testrictions may be noted on the g re-

caution sheet on the patient's chart. Nurses shouldat these positions and will post these times on the read these restrictions before administering topatient's chart and on his door. The results of daily the patients. Call the Nuclear Medicine Depart-surveys will be used to recalculate permitted times, ment or the Radiation Safety Officer with anywhich will be posted on the patient's chart and on his

questions about the care of these patients.door. Nursing personnel who attend the patient willD

4 The form. Nursing Instructions for Patients Treated wear personnel monitoring devices as advised bythe Radiation Safety Office.with Phosphoruv32, Gold 198, or lodine 131 (or a

similar form containing all the requested information),will be completed immediately af ter administration of b. Visitors will be limited to those 18 years of age or

over unless other instructions are noted on thethe treatment dose. A copy will be posted on theprecaution sheet on the patient's chart.

patient's chart.

Patients must remain in bed while visitors are in5. Radiation levels in unrestricted areas will be maintained c.

less than the limits specified in paragraph 20.105(b) of the room and visitors should remain at least 3 feet(or i m) from the patient.

10 CFR Part 20.

6. Alllinens will be surveyed for cxmtamination before being d. Patients containing radioactive materials are to beconfined to their rooms except for special medi-

removed from the patient's room and,if necessary, willcal or nursing purposes approved by the Nuclear

'

be held for decay.Medicme Department.

7 Disposable plates, cups, eating utensils, tissue, surgical No nurse, visitor, or attendant who is pregnantdressings, and other similar waste items will be placed

should be permittedin the room of a patient whoe.

in a specially designated container. The material will Sc has received a therapeutic amount of radioactivitycollected daily by the Radiation Safety Officer or nis

until the patient no longer presents a radiationdesignee. checked for contamination, and disposed of

hazard. Female visitors should be asked whetheras normal or radioactive waste, as appropriate.they are pregnant.

f. Attending personnel should wear rubber or dis-,,,,,,,,,,,,;,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,3,,,,,, posable plastic gloves when handling urinals,

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referencins procedures in Appendia K.

Item 19Page 23

9 6hodpans, emesis basins, e r <;ther containers h;ving (3) Disposable platn, cups, end eating ut:nsitu *

any materialobtained from tlw body ofIhe patient. will be used by patients who are treatedWash gloves before removing and then wash with I 131.hands. The gloves should be left in the patient'sroom in the designated waste container These (4) Vomiting withm 24 hours af ter oral admin-gloves need not be sterile or surgical in type. istration, unnary intx>ntmence. or excessive

sweating within the first 48 hours may result vg. Disposable items should be used in the care of in contamination of linen and floor, in any

these patients, whenever possible. These items situation where the patient's room may beshould be placed in the designated waste contain- contaminated or if radioattive unne and/orer. Contact the Radiation Safety Officer or his fcces is spilled during collection, call thedesignee for proper disposal of the contents of Radiation Safety Officer or his designee,the designated waste container. Ext. M::anwhile, handle all con-

taminated matenal with disposable glovesh. All clothes and hed linens used by the patient and avoid spreading contamination.

should be placed in the laundry bag provided andshould be left in the patient's room to be checked (5) Keep all contaminated wastes and vomitusby the Radiation Safety Officer or his designee. in plastic bags in the patient's room for

disposal by the Radiation Safety Officer ori. All nondisposable items should be placed in a his designec. Feces need not he routinely

plastic bag and should be left in the patient's saved unless ordered on the chart. The same~

room to be checked by the Radiation Safety toilet should be used by the patient at allOfficer or his designee. times and it should be well flushed (3 times).

The Radiation Safety Officer will establishj. Surgical dressings should he changed only as procedures for disposal of wastes (see

directed by the physician. Au-198 leaking from a item 12 below).puncture wound may stain the dressings dark redor purple. Such dressings should not be discarded I. If a nurse, attendant, or anyone else knows orbut should be collected in plastic bags and turned suspects that his or her skin or clothing, includingover to the Radiation Safety Officer or his desig- shoes, is contaminated. notify the Radiationnee. Handle these dressings only with tongs or Safety Officer or his designee immediately. Thistweezers. Wear disposable gloves. person should remain in an area adjacent to the

patient's room and should not walk about thek. For I-131 patients: hospital. If the hands become contaminated, wash

them immediately with soap and water, v(1) lo the degree possible with cooperative

patients, urine wd1 be collected in special m. If a therapy patient should need emergency sur-containers provided by the Radiation Safety gery or should die, notify the Radiation SafetyOfficer or his designee. The patient should Officer or the Nuclear Medicine Departmentbe encouraged to collect his own urine in immediately.the container. If the patientis bedridden, aseparate urinal or bed pan should be pro- n. When the patient is discharged, call the Radiationvided. The urinal or bed pan should be Safety Officer or his designee or the Nuclear Medi-flushed several tin.cs with hot soapy water cine Department and request that the room he sur-after use. vcyed for contamination hefore remaking the rannt

(2) If the nurse helps to collect the excreta, 12. Waste Disposaldisposable gloves should be worn. After-ward, hands should be washed with the When contaminated wastes are transported to the Wastegloves on and again after the gloves are re- Storage / Disposal area, precautions will be taken tomoved. The gloves should be placed in the minimize external irradiation of personnel. Storeddesignated waste container for disposal by westes will be shielded to maintain exposure to per-the Radiation Safety Officer or his designee. sonnelin restricted and unrestricted areas ALAR A.

Item 19"Page 24

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NURSING INSTRUCTIONS FOR PATIENTS TREATED WITHPHOSPHORUS 32, GOLD-198, OR IODINE 131

s'

Patient's Name :s

Room No.: _ Physician's Name:

Radioisotope Administered:

Date and Time of Administration:

Method of Administration:Dose Received:

Exposure Rates in mR/hr

10 feet from bed3 feet from bedDate

(Comply with all checked items)

1. Visiting time permitted:

2. Visitors must remain from patient.

3. Patient may not leave room.

(, 4. Visitors under 18 are not permitted.

5. Pregnant visitors are not permitted.

6. Film or TLD badges must be worn.

Pocket chambers will be worn for supplementary personnel monitoring of individual tasks.7

8. Tag the followmg objects and fill out the tag:

door chart

bed . w nst

9 Disposable gloves must be worn while attending patient.

10. Patient must use disposable utensils.

Allitems must remain in room until approved for rernoval by the Radiation Safety Officer or his designee.I 1.

12. Smoking is not permitted.

Room is not to be released to Admitting Office until approved by the Radiation Safety Officer or his designee..13.

14 Other instructions.In case of an emergency contact:

RSO

On-duty /Off. duty Telephone NumbernName

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RADIATION SAFETY PROCEDURES FOR IODINE 131 TilERAPY

Volatile iodine is released from therapeutic liquid iodine 131 solu-tions. Opening and preparing these solutions for patient administrationcan cause an airborn radioactivity hazard. The following procedureswill be observed in order to prevent contamination and thyroid uptake inindividuals who prepare and administer therapeutic quantities of iodine131:

A. Therapeutic doses of iodine 131 will be received, possessed and usedonly in capsule form, o r,

B. If therapeutic doses of iodine 131 are ordered for use in liquidform, personnel will be instructed as follows:

(1) Conduct procedures that involve opening and preparingtherapeutic liquid iodine 131 solutions in a fume hood withadequate airflow.

(2) Wear waterproof disposable gloves when opening and preparingiodine 131 solutions.

(3) Have your thyroid checked for the presence of iodine 131approximately 24 hours after opening or preparing therapeuticliquid iodine 131 solutions. Use the thyroid uptake equip-ment for this check. Report any counts above backgroundlevel to the radiation safety officer immediately.

Item 19

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APPENDIX L* *

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RADI ATION SAFETY PROCEDURES FORTHERAPEUTIC USE OF SEALED SOURCES'

Y- 1. All patients treated with brachytherapy sources will be be contacted to answer any questions about theplaced in a private room that has a toilet. care of these patientsin regard to radiation safety

precautions.2. Thx patient's room will be properly posted or attended in

accordancewith {{ 20.203 or 20.204 of 10 CFR Part 20. b. Nurses should spend only the minimum timenecessary near a patient for routine nursing care.

3. Surveys of the patient's room and surrounding areas Obtain and wear a film or TLD badge or a pockeIwill be conducted as soon as practicable after sources chamber as instructed by the Radiation Safetyarc implanted. Exposure rate measurements will be Officer.taken at 3 feet (or I m) from the pat;cnt with sourcesimplanted, at the patient's bedside, at 3 feet (or i m) c. When a nurse is assigned to a therapy patient, afrom the bed, and at the entrance to the room. The film or TLD badge should be obtained immedi-Radiation Safety Officer or his designee will then deter- ately from the Radiation Safety Officer or hismine how long a person may remain at these positions designee. The badge shall be worn only by theand will post these times and the exposure rate at 3 feet nurse to whom it is issaed and shall not be ex.(or i m) from the patient on the patient's chart. changed among nurses.

4. Immediately after sources are implanted, the form d. Pregnant nurses should not be assigned to the** Nursing Instructions for Patients Treated with Brachy- personal care of these patients.therapy Sources" will be completed and attached tothe patient's chart. e. Never touch needles, capsules, or containers hold-

ing brachytherapy sources, if a source becomes5. Radiation levels in unrestricted aress will be maintained dislodged, use long forceps and put it in the

less than the limits specified in paragraphs 20.105(bXI) corner of the room or in the shielded containerand (bX2iof 10 CFR Part 20. provided; contact Radiation Therapy, the Radia-

tion Safety Officer, or the Nuclear Medicine6. Nurses caring for brachytherapy patients will be assigned Department at once.

fdm or TLD badges. TLD finger badges will also beb assigned to nurses who must provide ex tended personal f. Bed hath given by the nurse should be omitted

care to the patient. Pocket dosimeters may be assigned while the sources are in place.in addition to a film or TLD badge.

g. Perineal care is not given during gynecologic7. At the conclusion of treatment, a survey will be per- treatment; the perineal ped may be changed when

formed in accordance with paragraph 35.14(bX5 Xvii) necessary unless orders to the contrary have beenof 10 CFR Part 35 to ensure that all sources other than written.permanent implants have been removed from the patientand that no sources remain in the patient's toom or in h. Surgical dressings and bandages used to cover theany other area occupied by the patient. At the same area of needle insertion may be changed only bytime, all radiation signs will be removed and all film the attending physician or radiologist and MAYand TLD badges assigned to nurses will be collected. If NOT BE DISCARDED untildirected by the radi-the patient is to be discharged, the final survey will ologist. Dressings should be kept in a basin untilalso include a notation on the patient's chart that the checked by the Radiation Safety Officer or hisactivity terrisining in the patient meets conditions for designee.release from the hospital.

. Special orders will be written for oral hygiene for8. Instructions to Nurses patients with oral implants.

a. Special restrictions may be noted on the precau- i. No special precautions are needed for sputum,tion sheet on the patient's chart. Nurses shouhl urine, vomitus, stools, dishes, instruments, orread these instructions before administering to utensils unless specifically ordered, but these

-

the patient. The Radiation Safety Officer should items should be saved for a check with a radia-*

ae sure to suewie ecmpiece raponses to items 20e ehraush 20f in tion survey meter to ensure that no sources haveaddition to referench , nrocedures in Appendia L. been inadvertently displaced into them.

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Item 20Page 27

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! j All bed linens must be ch;cked with a radiation o. Emergency Procedures * '.

survey meter before being removed from thepatient's room to ensure that no dislodged sources (Il if an implanted source becomes h>ose orare inadvertently removed. wparated from the patient, or

.

12) if the patient dies, or*,

Vk. These patients must stay in bed unless orders tothe contrary are written. In any event, patients (3) If the patient requires emergtency surgery,wi!! remain in their assagned rooms during the immediately calltreatment period.

Telephone No. (days)- 1. - Visitors will be limited to those 18 years of age or

(n@ts)over unless other instructions are noted on the,

precaution sheet on the patient's chart.p. At the conclusion of treatment, call the Radiation

m. Visitors should sit at least 3 feet (or I m) from Safety Officer to(l) survey the patient and room,,

the patient and should remain nolonger than the (2) count the radiation sources to he sure that alltime specified on the form posted on the patient's ' temporary implants have been removed prior todoce and on his chart. discharging the patient. and (3) record a summary

of the final survey results on the patient's chart.j n. No nurse, visitor, or attendant who is pregnant if any permanent implants are to remain in the

should be permitted in the room of a patientwhile patient, the Radiation Safety Officer will briefbrachytherapy sources are implanted in the pa- the patient on precautions for minimizing radia-tient. Female visitors should be asked whether ' tion exposure to others after discharge from thethey are pregnant. hospital.

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1 Item 20Page 28

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ATTACHMENT FOR SEALED THERAPY SOURCES OF GROUP VI

INFORMATION REQUESTED

Only two radionuclides in sealed form are to be used at thisinstitution: Iridium 192 and Iodine 125. Iridium 192 will bepurchased as- needed from Alpha 0mega and Iodine 125 will bepurchased as needed from 3M corporation.

1. The'ar.eas where the sealed sources (Ir-192 and I-125)will be stored. (1) Placement and thickness of the shieldingmaterial, (2) the proximity of the storage area to unrestrictedareas and (3) appropriate calculations.

Ir192 and I-125 upon receipt will be stored the theNuclear Medicine hot lab. Until use they will be storedin the containers in which they were shipped. Inaddition they will be stored behind a row of leadedbricks 2 inches in thickness which together with theshipping container shielding will be more than adequateto protect public and personnel alike.

The Nuclear Medicine hot lab is not adjacent to anyunrestricted areas. It is completely controlled and onlypersons appropriately trained are allowed in the area.

The half-value-layer of lead for Iridium 192 is on theorder of one tenth of an inch. Two inches of lead (20HVL, at least) will be more than adequate for protection.The HVL of lead for Iodine-125 is even less hence properprotection will be maintained for this radionuclide aswell.

2. Special Handling Precautions

The Iridium 192 and the Iodine 125 seeds will be handledonly with appropriate forceps. Iridium will be prepackedin ribbons. Iodine 125 will be loaded in the applicatorcartridges with six inch forceps.

3 Extremity Doses for Personnel Handling Material

These doses will be determined using finger TLD badgessupplied by our film badge supplier...Landauer.

-4. Transporting sources from Storage Site to Place of Use.

Iridium 192 ribbons will be afterloaded in the patient'sroom. The sources will be transported to the room in thecontainer in which they were shipped to the institution.On the cart with the shipping container will be a leadedshield behind which persons assisting with the

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application can manipulate the sources prior to use.

Iodine 125 willLbe applied in surgery. The seeds will belocated in the Iodine 125 gun cartridge until' they areactually installed in the patient. They will be' transported to surgery in the cartridges. The cartridgestogether- with the. cartridge holder are designed toprovide adequate protection for the very soft Iodine 125 -

x-ray.

5. Source Accountability

For each shipment of Iridium 192 or Iodine 125 a controlform is prepared. This control form is designed to

_ _

contain ordering information, receipt information, useinformation and disposal information. A copy of the formin use is hereby attached. This form is filled in forboth radionuclides; one ' shipment, one form. Our ChiefNuclear Medicine Technician is designated custodian ofthe' sealed therapy sources. She/He will be responsiblefor filling in the control form and accounting for thesources.-

Our^use of these nuclides is rare. After the Iridium hasbeen used in the patient it will immediately be returnedto the supplier, Alpha 0mega. In the case of Iodine 125(a permanent seed implant) thout seeds not used will bereturned -to 3M. The' institution . ill not have anywpermanent. supply of sealed sources for therapeuticpurposes. The control form has provision for accountingfor.the seeds-of Iridium removed from the patient at theend of treatment.

In compliance with 10 CFR 35.14(b)(5)(vii) pat'ients willbe required to-be hospitalized while treated with Iridium192. They will not be released until .such a time thatsurveys reveal all sources to have been removed from thepatient.

Periodic inventories of therapeutic sealed sources arenot required since the sources will be totally accountedfor after each application and returned to the suppliers-for disposal.

6.. Surveys To Be Performedi

Surveys'will be performed before a patient. who has been j' instilled with radioactive materials will .tur allowed to |leave the hospital. All Iridium 192 sources by physical Icount will be accounted for. .The room and patient will i

be monitered with GM detectors to insure-that.a source |was-not missed.during the count. In the case of Iodine i.125, the patiet will of course. carry his sources with ;him. The -room will :tur properly surveyed not only prior |

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to his discharge but also frequently during the course ofhis stay to insure that sources which may becomedislodged from say a prostate application are found and

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properly disposed of. The room will be survey prior to '

patient discharge and prior to use.by another patient.

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ISOrIOPE A000LWfING IDR11 .

Reconi of Receipt, Use, Disposal

Isotope:,

ntte Onlered: Dated Needed: Date Received:

Purchase Order No.: Shipnent No.: Cost:.

Ibrson Tnking Order: . Shipnent I.D. :.

CoptainerNo.: hTo of Ribbons: No. of Seeds:

Assay / Seed (MRE): * No. of Mi111 curies:

Rttient Application:

natient: Patient:In Date: Time: In Date: Time:Out Ihte: Time: Out Date: Time:No. of Seeds Used: No. of Seeds Used:

Ritient: Patient:In Date: Time: In Date: Time:Out Ihte: Time: Out Date: Time:1. of Seeds Used: No. of Seeds Used: h

i

Control: Original No. of Seeds:01eck No. of Ribinns, Seeds: Date: By: t

No. of Ribbons (Seeds) Returned: By.. -

Date Returned:No. of Seeds Not Returned:thy Seeds Not Returned:

Cam ents:

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NURSING INSTRUCTIONS FOR PATIENTS TREATEDWITH BRACHYTHERAPY SOURCES

Patient's Name:-

Room Number: Physician's Name:

Isotope and Activityi

Date and Time of Administration :

Date and Time Sources Are To Be Removed : Isotope :

Exposure Rates in mR/hr

Bedeede 3 feet from bed . 10 feet from bed

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(Comply with all checked items.)

1. Wear film or TLD badge.

2. Wear pocket chambers for supplementary personnel monitoring of individual tasks.

3. Wear rubber gloves.

4 Tag the followir.g objects and fill out the tag:

door chart

bed wrist

5. Place laundry in linen bag and save.

6. Housekeeping may not enter the room.

o7 Visiting ti ne permitted:

8. Visitors must remain from patient.

_

9. Patient may not leave the room.

10. Patient may not have visitors.

11. Patient may not have pregnant visitors.

I 2. Patient may not have visitors under 18 years of age.

13. Patient must have a private room.

14. A dismissal survey must be performed before the patient is discharged.

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Item 20Page 29

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. ..15. All items erst remain b th3 room pItil approved for disposal by the Radiation Safity Officer or his -

designee. |

16. Contact the Radiation Safety Office when temporary sources (nonpermanent implants) are removed toi

perform a survey to he sure all sources are removed from the patient, to do a physical source' count, and to '

be sure no sources remain in the room. |

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17. Contact the Radiation Safety Office when the patient is discharged to survey the room prior to its assign-ment to another patient.

I 8. Other instructions.

RSO

Name On-duty /Off-duty Telephone Numbers

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APPENDIX O

MODEL PROGRAM FOR MAINTAINING OCCUPAYlONAL R ADIATION EXPOSURESAT MEDICAL INSTITUTIONS ALARA

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(Licensee's Name)<

(Date)

1. Management Commitment 2. Radiation Safety Committee (RSC)I

a. We, the management of this (medical facility, a. Review of propowd Users and Uwshospital, cie.), are committed to the programdescribed in this paper for keeping exposures (1) The RSC will thoroughly revie w the(individual and collective) as low as is reasonably clualifications of each applicant withachievable ( ALARA). In accord with this com- respect to the types and quantities utmitment, we hereby describe an admmistrative materials and uses for whkh h t' hasorganization for radiation safety and will develop applied to ensure that the applkant willthe necessary written policy, procedures, and be able to take appropriate measures toinstructions to foster the ALARA concept with- maintam exposure ALAR A.in our institution. The organization wdlincludea Radiation Safety Committee (RSC)' and a (2) When considering a new use of byproductRadiation Safety Officer (RSO). material, the RSC will review the efforts

of the applicant to maintam cuposureb. We will perform a formal annual revsew of the ALARA. The user should have systematued

radiation safety program, including ALAR A procedures to ensure ALAR A and shallconsiderations. This shall include reviews of have incorporated the use of specialoperating procedures and past exposure records, equipment such as syrmge .shiehlt rubterinspections, etc., and consultations with the gloves, etc., in his proposed use.radiation protection staff or outside consultants.

(3) The RSC will ensure that the userjustifiesc. Modification to operatmg and maintenance pro- his procedures and that dose will be ALARA

cedures and to equipment and facdities will be (mdividual and collectivetmade where they wdl reduce exposures unicuthe cost, in our judgment, is considered to be b. Delegation of Authorityunjustified. We will be able to demonstrate, ifnecessary, that improvements have been sought, ( The judicious delegation of RSC authority isthat modifications have been considered,andthat essential to the enforcement of an ALARAthey have been implemented where reasonable. program.)Where modifications have been recommendestbut not implemented, we will be prepared to (1) The RSC wdl delegate authonty to thedescribe the reasons for not implementing them. RSO for enforcement of the ALAR A

concept.d. ' In addition to maintaining doses to mdividuals

as far below the hmits as is reasonably achievable, (2) The RSC wdl support the RSO in those- the sum of the doses received by all exposed instances where it is necessary for the RSOindividuals will also be maintamed at tbc lowest to assert his/her authority. Where thepracticable level it would not be desirable, for RSO has been overruleit, the committeeexample, to hold the highest doses toindividuals will record the basis for its action m theto some fraction of the applicable limit af this minutes of the Committeci cluarterlyinvolved exposing additional people and signit- meeting,scantly increasing the sum of radi.ition dosesreceived by allinvo!ved individuals.

I The RSO on private pracine physkian li<enses will assume thePrivate practice physician licenses do not include an R50. responsibilitws or the RSC under $ccison 2

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Item 24Page 31

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c. Review of ALAR A Program (2) The RSO willexsure that althorizzd users, ',

workers, and anedlary personnel who may,

- (1) The RSC will encourage all users to review be exposed to radiation wdl be instructedcurrent procedures and develop new pro- in the ALARA philosophy and informed*

cedures as appropriate to impleinent the that managesnent, the RSC, and the RSO. ALARA concept. are committed to implementing the I

: AIARA concept. ' ' i(2) The RSC wal perform a quarterly review ,

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of occupational radiation exposure with c. Cooperative Efforts for Development of A LAR A |

particular attention to instances where Proceduresinvestigational Levels in Table 01 below f

are exceeded. The principal purpons of Radiation workers wdl be given opportunitiesthis review is to sesses trends in occupa- to participate in formulation of the procedures j

tional exposure as an index of the ALARA that they will be required to follow.. Program quality and to decide if action iswarranted when Investigational Levels are (1) The RSO will be in close contact with all i

- exceeded (see Section 6).3 users and workers in order to develop i

ALARA procedures for working with, .

radioactive materials.! (3) The RSC will evaluate our institution's; overall efforts for maintaining exposures

. |! ALARA on an annual basis. This review (2) ~ The RSO wdl establish procedures for !

'

willinclude theeffortsof the RSO, autho- receiving and evaluating the suggestions of'

| rized users, and workers as well as those individual workers for improving healthi. of management, physics practices and will encourage thei use of those procedures.

- 3. Radiation Safety Officer (RSO) -

d. Reviewing Instances of Deviation from Good i

a. Annual and Quarterly Review ALAR A Practices

) (1) Annual review of the radiation safety pro- The RSO will investigate all known instances j

i yam. The RSO wdl perform an annual re- of deviation from good ALARA practices and, *

# view of the radiation safety program for if possible, will determine the causes. When theadherence to ALARA concepts. Reviews cause is known, the RSO will require changes

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of specific proceaures may be conducted in the program to maintain exposures ALARA.,

on a more frequent basis. ' '

!' 4 Authorized Users {(2) Quarterly review of occupational expo- ,

sures. The RSO will review at least quar- a. New Procedures involving Potential Radiation !terly the external radiation exposures of Exposures ,

authorized users and workers to determine [that their exposures are ALARA in accord- (1) The authorized user wdl consult with,and ;

anee with the provisions of Section 6 of receive the approval of, the RSO and/orthis program. RSC during the planning stage before using

;

radioactive materials for a new procedure. ~

(3) Quarterly review of records of radiationlevel surveys. The RSO will review radia- (2) The authorized user will evaluate all proce- ;

tion levels in unrestricted and restricted dures before using radioactive materialsaress' to determine that they were at to ensure that exposures will be kept

~,

A L A R A levels during the previous quarter. ALARA. This may be enhanced through ,

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the application of trial runs.h. . Education Responsibilities for ALARA Program t

b. Responsibility of Authorized User to Persons i

(li The RSO will schedule briefings and educa- Under His/Her Supervisiontional . sessions to inform workers ofALARA program efforts. '( 1) The authorized user will explain the

ALARA concept and his/hercommitmentto maintain exposures AIARA to all per-

3 *

The NRC has emphasised that the Investigational f.evelsin thisprogram are not new dnee Hmits best, as noted 6n ICRP Meport 2a,"Recommendat6ans of the laternational Commission on Rad 6 alogical (2) The authorized user will ensure that per-Protection.** serve as check pnents above which the results are can-stemd surviciently impartant to justiry rurther investigat6ons. sons under his/her supervision who are

Item 24 Cont'd,

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9 radiatioi

# 0, subject to occupation- ex po- c. Quart:rly exposure of individurls to lew than

sure are trained and educated in good investigational Level I.health physics practices and in maintainingexposures ALARA. liscept when deemed appropriate by the RSO.

no further action will be taken in those caseswhere an individual's exposure is less than

n 5. IVrsons Who Receive Occupational Radiation Exposure Table 0-1 values for the Investigational Level 1.

a. The worker will be instructed in the ALARA b. Personnel exposures equal to or greater thanconcept and its relationship to working proce- Investigational Level I, but less than investiga-dures ar.d work conditions. tional Level 11.

b. The worker will know what recourses are avail- The RSO will review the exposure of each mdi-able if he/she feels that ALARA is not being vidual whose quarterly ex posu res equat or exceedpromoted on the job. Investigational Levell and will report the results

of the reviews at the first RSC meeting following6. Establishment of Investigational Levels In Order to the quarter when the exposure was recorded. If

Monitor Individual Occupational External Radiation the exposure does not equal or exceed Investiga-Exposures tional LevelII, no action related specifically to

the exposure is required unless deemed appro-This institu tion (or private practice) hereby establishes priate by the Committee The Committee will,investigational Levels for occupational external radia- however, consider each such exposure in com-tion exposure which, when exceeded, will initiate parison with those of others performing similarreview or investigation by the RSC and/or the RSO. tasks as an index of ALARA program qualityThe Investigational l evels that we have adopted are and will record the review in the Committeelisted in Table O-1 below. These levels apply to the minutes.exposure of individual workers.

c. Exposure equal to or greater than investiga-tional Level ll.

Table 01The RSO willinvestigate in a timely manner the

In restigational Levels cause(s) of all personnel ex posures equalmg or ex-/mrems per calendar quarter) ceeding Investigational Level 11 and,if warranted,

will take action. A report of the investigation ac-% 1.crel l Lereill tions taken,if any,and a copy of the individual's

Form NRC-5 or its equivalent will be presented1. Whole body; head and 125 375 to the RSC at the first RSC meetmg following

trunk ; active blood-forming completion of the investigation. The details oforgans; tens of eyes; or these reports will be recorded in the RSC minutes.gonads Committee minutes will be sent to the manage-

ment of this institution for review. The minutes,2. Ilands and forearms; feet 1875 5625 containing details of the investigation, will be

and ankles made available to NRC inspectors for review atthe time of the next inspection.

3. Skin of whole body * 750 2250d. Reestablishment of an individual occupational

worker's investigational Leveill to a level above' 'Not normally applicable to nuclear medicine operations encept

those using signirkant quantities or beta <mitting isotopes.In cases where a worker's or a group of workers'ex posures need to exceed Investigational Level !La new, higher Investigational levei ll may be

The Radiation Safety Officer will review and record established on the basis that it is conustent withon Form NRC-5, " Current Occupational External good ALARA practices for that individual or

Radiation Fxposures," or an equivaler;t form (e g., group. Justification for a new Investigationaldosimeter processor's report), results of personnel Level 11 will be documented.monitoring not less than once in any calendar quarteras required by @ 20.401 of 10 CFR Part 20. The follow- The RSC will review the justification for, and willing actions will be taken at the investigational Levels approve, all revisions of Investigational L cvel 11.as stated in Table 0-1 In such cases. when the exposure equals or exceeds

item 24 Cont'd

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'the newly (stiblished InvIstigattan;l Level 11 _

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those actions listed in paragraph 6.c above will Signaturebe followed.

7.- Signature of Certifying Official" Name (print or type)

I hereby certify that this institution (or private prac- %

tice) has implemented the ALARA Program set forth Title; above.

Institution (or Private Practice) Name and Address:

"The per'on who is authortaed to make commitments for thesdministrasson of the institution (e.g., hospital administrator) or.a the case of a private practice the licensed physic 6an.

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Item 24 Cont'd

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