Text

Voided Matls Licensing Action for Internal Medicine Specialties.Control:109264
	ML20033F679
Person / Time
Issue date:	11/30/1988
From:	; NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:	; NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM)
References
	109264, NUDOCS 9003260146
	Download: ML20033F679 (54)
	v • d • e

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'1 -j6 \\, UNITED STATES NUCLEAR REGULATORY COMMISSIEN p ,j-REGION I e I 475 ALLENoALE ROAD -1 /- ' KING OF PRUS$1A, PENNSYLVANIA 19408 s t80 Nov 1988 License No, </ /// / ' Control No.,/09 M f

Dear Applicant:

Your application assigned to'the above Control Number has been voided because of your failure to respond in a timely manner to our letter dated (MA-(Jg7 ~ requesting additional information. This action is taken without prejudice to the resubmission of this application with the requested information. prompt resubmission will most _likely not require l an additional fee. To aid our License Fee Management Branch, any resubmission should' refer to this letter and the above Control Number. .l 0' / / /c - - e. [ Nuclear Materials Safety Section o

Enclosure:

Letter dated CM/er /_ //ll' / i J l-1 l OFFICIAL RECORD COPY NL 10 1

m w A i 106 uu 1988

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Docket' No. ~030-30718-l ] L Control No~. 109264 I Internal Medicine Specialities, P-.C. 3 ATTN: Marvin L. Rosner, D.0. l Suite 202 201 North 8th Street Phliadelphia, Pennsylvania 19106

Dear Dr. Rosner:

This is in reference to your application dated July 19, 1988 for a byproduct Material License. In order to continue our review, we need the 1 following additional information: i 1. Please have Dr. Philip Shtasel confirm that the 500 hours of clinical-training included requirements specified in 10 CFR 35.920(b)(2). 1 (Enclosed). ' Since this license will authorize.use of Tc-99m, you will j need to document clinical experience with procedures using this isotope. i 2. A licensee authorized to use byproduct material for imaging and localiza-tion ~is required by 10 CFR 35.220 (enclosed) to have a portable radiation detection survey instrument capable of detecting dose rates over the range of 0.1 millirem per hour to 100 millirem per hour, and a portable i radiation measurement survey instrument capable of measuring dose rates over the range 1 millirem per hour to 1000 millirem per hour. Please I provide the manufacturers and model numbers of the instruments you will use to meet these requirements for a measurement survey instrument and a j detection survey instrument. 4 3. 10 CFR 35.51 requires, that at the time of survey meter calibration, the apparent exposure rate from a built-in or owner-supplied check source be -determined and recorded and that each survey instrument be checked with j the dedicated check source each day of use. Please confirm that your procedures will include these requirements. .I 4. 10 CFR 35.50(b)(3) (enclosed)' requires that the dose calibrator linearity l test be performed over the. range of its use between the highest dosage that will be administered to a patient and 10 microcuries. Please confirm that you will _ comply 'with 10 CFR 35.50(b)(3). j i i i 0FFICIAL RECORD COPY ML 502 TRIPP - 0001.0.0 g g 10/05/88 i 3

7- / Internal Medicine Specialities, P.C. 2 5. 10 CFR 35.70(d) requires licensee's to establish dose rate trigger-levels. Please specify your dose rate trigger levels in mR/hr for your-restricted' areas and for your unrestricted areas. We find 0.5 mR/hr for unrestricted areas and 5.0 mR/hr for restricted areas to be acceptable dose rate trigger levels. We will continue our review upon receipt of this information. Please reply in duplicate to my attention at the Region-I office and refer to Mail Control No. 309264. If we do not receive a reply from you within 30 calendar days from the date of this letter, we shall assume that you do not wish to pursue your application. Sincerely, Driginal Signed RTt ' John E. 'G1enu John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section A Division of Radiation Safety and Safeguards

Enclosures:

10 CFR Part 35 RI:DRSS RI:0RSS Tripp/pmb/ tim Glenn 10/(p /88 10/b/88 OFFICIAL RECORD COPY ML 502 TRIPP - 0002.0.0 10/05/88 ML 10 L

g; NRC FORM 313. U.S. NUCLE A3 LEQULATORY COMMtsSION (1487) -. s .f[ ] - saw 130 APPZVEJ OY OMS to CPI 30,32,33,34 31660

S =* 40

. APPLICATION FOR MATERIAL LICENSE =

S a>a 630 MOM 1988T!.UCTIONS: SEE THE APPROPRI ATE LICENSE APPLICATION GUIDE FOR DET AILEO INSTRUCTIONS FOR COMPLETING APPLICATION, SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIED BELOW.

APPUCATIONS FOR DISTRIBUTION OF EXEMPT PROOUCTS FILE APPUCATIONS WITH: IF YOU ARE LOCATED IN: US NUCLtAR REGULATORY COMMISSION It UNOIS, INDI ANA, IOW A, MICHIG AN, MINN ESOT A, MISSOURI, OHlO, OR , DIV'SION OF FUEL CYCLE AND MATERIAL SAFETY, NMSS Wl8CONSlN,SENO APPtlCATIONS TO: uY 9

Wl,$HINGTON, DC 20EES (G

U.S NUCLE AR REGULATORY COMMISSION, RtGION lli ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS,IF YOU ARE MATE' IALS LlCENSING SECTION LOCATED IN: 799 ROOSEVELT ROAD. COfessECTICUT, DELAWARE, OlSTRICT OF COLUMBIA. MAINE MARYLAND, anaam*CHUSETTS. NEW HAMPSHIRE, NEW JERSEY, NEW YORK, PENNSYLVANIA, ARK ANSAS. COLOR ADO, lDAHO. K ANSAS, LOU 183 AN A, MONT ANA, NESRASK A. RHODE ISLAND. OR VERMONT, SEND APPUCATIONS TO: NEW MEXICO, NORTH DAKOTA, OKLAHOMA, SOUTH DAKOT A,TEKAS, UT AM, , U.S. NUCLEAR REGULATORY COMMIS$10N, REGION 1 NUCLEAR MATERIALS SAFETY SECTION 9 U S. NUCLE AR REGULATORY COMMISSION, REGION IV 476 ALLENDAlt ROAD MATERIAL RADtAYlON PROTECTION SECTION i KING OF PRUSSIA, PA 19408 611 RYAN PLAZA DRivt,SulTE 1000 ALASAMA, FLORIDA. OEORotA, KENTUCKY, MISSIS $6PPl, NORTH CAROLINA, PUE;.TO ReCO. SOUTH CAROLINA, TENNESSit, VIR0lNIA, VIRGIN ISLANDS, OR AL ASKA, AR120NA, CAUFORNI A, HAWAll, NEV ADA, OR EGON, WASHipeOTON, j WEST VIROINIA, SEND APPLICATIONS TO: AND U.S. TERRITORIES AND POSSESSIONS IN THE PACIFIC, SEND APPtlCATIONS U.S NUCLEAR REGULATORY COMMIS$10N, REGION 11 NUCLAR MATERIALS SAFETY SECTION U.S. NUCLEAR REGULATORY COMMISSION, REGION V 101 MARIETTA STREET, SulTE 21100 NUCLEAR MATERIALS SAFETY $ECTION ATLANT A, GA 3mI23 - 1460 MARIA LANE, SUITE 210 WALNUT CREEK, CA 94608 PER80808 LOCATED IN AGREEMENT STATES SENO APPLICATIONS TO THE U.S. NUCLEAR R10ULATORY COMMISSION ONLY 17 THEY WlSH TO POSSESS AND USE LICENSED MATERIAL IN ST Af t4 SUSJECT TO U.S. NUCLEAR REQULATORY COMMIS&lON JURIEDICTION. - 1.TH18 68 AN APPLICATION FOR (Chece aper.pnew ten)

2. NAME AND MAIUNG ADDRESS OF APPUCANT (facAwe 4 Coe) 1

^ N5W uCENS5 Marvin L. Rosner, DO, FAC01 Internal Medicine-Specialties, PC S. AMENoMENT TO uCENSE NUMO*a . C, RENEWAt OF uCEN$r NUM.5a Suite 202 201 North Ath 9treet

3. ADOFIE85(ESj WHERE LICENSED MATERIAL WILL SE USED OR POSSESSED.

Phi 1ade1phia, PA 19106

as in 2.

above------------ l

4. NAME OF PERSON TO BE CONT ACTED ABOUT THIS APPLICATION TELEPHONE NUMSER 215-238-2311

$USMIT ffEMS S THROUGH 11 ON 84 a 11" PAPER. THE TYPE AND SCOPE OF INFORMAtlON TO 85 PROvlOEO IS PESCRietD IN THE UCENSE APPLICATION GUIDE. S. EtADIOACTIVE MATERIAL ~ W a Ei.meo.ad me.ss.nu.mm.er, th, c%emicas sad /or pnyme form and e. masimum smount - S. PURPO$ tis 1 FOR WHICH TIu cTe a r bWILL8E,US'i.*ar 1o ogy on1y s nt e o d ENS MATE RI A Human-Use. attaehed i ev.o. e. 1 ' 7. VI UALS E $OL FOR R ADIATION A ETY PR GRA AND THilR S TR b M FO I Otv DUA WORK NQ IN OR FREOUENTING RESTRICTED ARE AS.

9. Pt.CILITIES AND EOUIPMENT,

10. RADtATION SAFETY PROGRAM-attached

12. LICENSEE F EES iSee fd C## l/OsadSection f/0.Jtt

. l'E"O$ED s - 580.00

n. WASTE MANAGEMENT.

attached FEtCAftGOav-R

13. CERTIFICATION. (Mwt ce compteeser aperent) THE APPUCANT UNDERST ANDS THAT ALL ST ATEMENTS AND REPRESENT ATIONS MADE IN THe8 APPLICATION ARE SINDING UPON THE APPUCANT.

THE APPLICANT AND ANY OFFICIAL ExkCUTING THis CERTIFICATION ON 8tHALF OF THE APPLICANT. NAMED IN ITEM 2. CERTIFY THAT THIS APPUCATION IS PREPARED IN CONFORMITY WITH TITLE 10, CODE OF FEDERAL REGULATIONS, PARTS 30,32,33,34,3S, AND 40 AND THAT ALL INFORMATION CONTAINED HEREIN, 18 TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BEUEF. WARNING: 18 U S C. SECTION 1001 ACT OF JUNE 25,1948. 82 STAT. 749 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JURISOICTION. SIGN *.TURE-CERTIF YING OF FICE R TYPED / PRINTED AMT TITLE DATE/dMff '/ p-t Marvin Le Rosner, DO Physicina/ Applicant l i FOR NRC USE ONLY W g + 6g b l COMMENTS Y i TYesOFFEE m LOG nE CATEGORY Cpw A L A a-J m Ar,R9vfD w4 w~y -%fd f , % q. gent REo,YED 'hW .TE CHECK NUM..R 0 gf dD w zw [ "0FHCIAL RECORD COPY"gg r-zo

APPUCATION POR MATERIAL UCENSE

~ DOCUMENTATION OF ATTACHMENTS TO THIS APPLICATION Attachment Description Of The Attachment Enclosed-Section A. Description Of The Scope Of The Operation B. Radioactive Materials Requested In This Application C. Training And Experience Of Authorized User And Rad-iation Safety Officer D. Personnel Qualifications And Training E. Facilities And Related Equipment F. Radiation Detection Instrumentation G. Calibration Of The Survey Instrument H. Calibration Of The Dose Calibrator I. Quality Control Of The Gamma Camera J. Personnel External Monitoring Program Radiation Safety Committee ALARA Program K. Leak Testing Of Sealed Sources L. Rules For.The Safe Use Of Radiopharmaceuticals + M. Procedure For Spills N. Procedure For Ordering Radioactive Materials 0. Procedure For Opening Packages P. Radiopharmaceutical Records Q. Procedure For Area Surveys R. Radioisotope Waste Disposal Procedure The above documents will be found in this order in the following pages. l l l L L

APPUCATION FOR MATERIAL UCENSE Attachment A.. ' DESCRIPTION.0F THE SCOPE OF THE OPERATION This;1icense application is for nuclear cardiology procedures only.. The procedures will be implemented in a private practice facility. The mat-erials used will be obtained from a radiopharmacy. The applicant will-not obtain a 99mTc/99Mo generator. There is no intent to purchase any materials in." bulk"' form, and all sources will be-obtained in unidose i ~ from form the radiopharmacy. A111 radioactive wastes that came f rom the radiopharmacy, ie spoiled uni-doses or used syringes that contain residual activity, will' be returned to the radiopharmacy for disposal and records of this transfer will be ~l maintained.by the applicant. Other wastes, ie wipes and contaminated materials will be stored by the applicant for decay in storage (DIS). 'If the scope of.the operation needs to be changed to meet the medical needs of-the applicant-physician the application will be amended prior

to those changes, j

i I

p p APPUCATION FOR MATERLAL UCENSE Attachment B. RADI0 ACTIVE MATERIALS REQUESTED IN THIS APPLICATION Radiopharmaceuticals The applicant wiches to receive a license for only nuclear cardiology procedures. These procedures, to be performed!in an out-patient fac-ility,.will be limited to: . Item 6. Radioisotope Form Amount, mC1 Purpose Of Use Of Each Form 99m Tc* Pertechnetate 80.00 Human Use HSA 40.00-Human Use PYP 40.00 Human Use 201 Tl Chloride 60.00 Human Use -99m Tc* Pertechnetate 5.00 Quality Control & Calibration 3 201 Tl Chloride 1.00 Quality Control'& Calibration-Sealed Sources for Quality Control and Calibrationtas described on the next page. '* Note: The sources of 99m Tc and 201 T1 will be obtained from the radiopharmaceutical supplier in unidose or multidose form. The--applicant will not obtain a generator for 99m Tc or make " kits" using the radiopharmaceuticals-listed in'this applicat-ion. (The " supplier" includes the radiopharmacy) All unused sources and contaminated syringes etc that are obtained from the radiopharmacy will be returned to the rad-iopharmacy for disposal. Only those materials originating in'the facility, ie wipes etc will be kept in the facility for decay in storage (DIS).

APPUCATION FOR MATERIAL LICENSE Sealed Sources The sealed sources will be obtained from Atomic Produ~ cts Corporation, P.O. Box R Shirley, New York 11967 The Sources used for the dose calibrator are: Element and Mass Number Form Max., mci Catalogue Number-Ba-133 sealed 0.250 063-562 Cs 137 sealed 0.200 101-356 Co 57 sealed 5.000 063-261 The Sources used for the gamma camera are: Element and Mass Number Form Max., mci Catalogue Number I Co 57 sealed 5.000 062-295 A description of the sources, as provided by the supplier, are given in the information below. L -Isotope Calibrator . Reference Sources Cobalt 57 Flood Sources l 4

For checking calibrator securacy, intended litet.

. performance and consistency.

Dally intrinsic uniformity checkt Good' practice dictates, and regula-
Extrinsic collimator checks e

tory agencies _ recommend, that isotope ~ calibrators used for measuring diagno-

l.inearity and resolution cliecks stic and therapeutic doses of radio-with bar phantom pharmaceuticals be checked regularly
' AS trentmlSSlon Sources over the calibrator's range of measurements. Calibratc.r
Quality control for accredidation pstformance is easily monitored by using the fo! lowing calibrated standards to verify the accuracy of its and regulatory requirements assays:

- (c) A long lived source, such as "'Cs (T% = 30 yrs.), to The Sources contain Cobalt 57, uniformly dispersed . avoid the tedium of constant decay corrections, in a plastic disc, which is completely encased in an at-(b) A "Co source (T% - = 270 days) that simulates tractive aluminum cover. Each source is supplied in a 99m Tc, the most common radioisotope in nuclear lead shielded wooded carrying case. The shielding'. medicine.- reduces the exposure rate at the front surface to ap-proximately 1.4mR/hr. By keeping a daily log of the values obtained on Emission non uniformity (distribution) less than 1%, silected ranges with both standards, the user develops Available in three sizes. a performance record that detects calibrator error or failure before a mistake is made in a patient's dose. Both sources are supplied in 20ml epoxy in a 27ml Flood Source: plastic vial,85 mm H x 30 mm D. Calibrated to

5%.

063 562 a ib ted Barium 133 Source' 062 295 M' diameter,5 mci l 101 356 Calibrated "'Cs Source 1 200uCl 063 261 Calibrated Simulated 9m Tc Source (Cobalt 57),5 mci

i L APPUCATION FOR MATERIAL UCENSE Attachment C. 1 d LTRAINING AND EXPERIENCE OF AUTHORIZED USER AND RADIATION SAFETY OFFICER Th'e attached documents document the training and experience of the phy-sician applicant. The documents'show the Basics of Radioisotope Handl-ing training as 200+ hours and Preceptored Clinical Experience. There is additional Clinical Experience but additional documentation should not be-required of the applicant. A description of the training program provided by the Institute For Nuc-lear Medical Education is on file with your agency. This training program has been-reviewed by all NRC Regions'and by most Agreement States and has'also been reviewed by.the State of Colorado, Radiological Health Sect. ion, Charles Mattson. The program has been submitted by several agencies including the State of Colorado, for inclusion in the NRC list of Service j ~and Training Programs. If additional information of this program is re-quired, please contact: Charles H. Rose, MA,MSPH,D(ABSNM) ) Program Director -) Institute For Nuclear Medical Education y 3011 Broadway Boulder, Colorado 80302 303-444-1943 i 1 I I h s I

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E METROPOLITAN HOSPITAL Central Division 201 North Eighth Street Philadelphia, Pennsylvania 19106 i (215) 238 2000 l June. 23,1988 This is to. certify that Marvin L. Rosner, D.O. has gained clinical experience at Metropolitan Hospital, Central Division in the area of nuclear cardiology. This period of supervised clinical Gxperience was an aggregate of over 500 hours. During this period, he was active in the clinical participation of the following studies: Thallium Stress Studies 20lT1 - The experience was limited to the above, and if additional experience is obtained, it will-be included on a future statement. 3 Philip Shtasel,1 D.O. k$f / g um j I gen ALDINE C. GULLET T Notary Put: tic. Pmta., Ph.:a. Co ' My Commission Empires April 24, IE s A Non profit Osteopathic Mulu hospital System

1 APPUCATION FOR MATERIAL UCENSE Attachment D. 1 PERSONNEL QUALIFICATIONS AND TRAINING TechnologistLQualifications All technologists, nuclear nedical technologists, will be registered or certifice in nuclear medicine by the ARRT. SNMT or ASCP, or they will, if allowed by local or state laws, have the equivalent training in nuclear medicine. If local or state laws require registration / certification and a state license then those laws will be complied with by the applicant. In addition to the above, the physician applicant will interview the tech-nologist and_obtain a resume of his/her experience and will evaluate the technologist through close observation of the nuclear medical techniquies of the technologist in the actual operation. j Personnel Training Program Who will be instructed: All personnel, professional / technical and ancillary will be instructed. The professional / technical personnel will include but not be limited to: technologists, authorized users, physicists and physicians who are not authorized users but may be present when byproduct material is being used. The ancillary personnel include the nursing, clerical, housekeeping. and other personnel who may frequent the area where material is being used. Instruction Frequency: Personnel will be_ instructed before assuming duties with or in the vacin-ity' of. radioactive materials, during an annual refresher training pro-gram and whenever there is a significant change in the duties, regulat-ions or terms of the license. There will also be instruction as deemed necessary by the RS0 for all personnel af ter spills, misadministrations, and other incidents including high personnel exposure as determined by i personnel monitoring. Topics of Instruction: Insturction will include but not be linited to the following subjects: a) Applicable regualtions and license conditions b) Areas where radioactive materials are used or stored c) Potential hazards associated with radioactive materials and proced- - ures for each area where employees work including bio-hazards d) Appropriate radiation safety procedures e) Licensee's in-hours work rules ( f) Easch individual's obligation to report unsafe conditions to the RSO g) Appropriate response to emergencies or unsafe conditions h) Personnel who work with the materials will also receive copies of- -the procedures for-monitoring the performance of imaging equipment, l ordering and receiving radioactive material, opening packages, rec-ords of byproduct material use, radiation area surveys, safe use of radiopharmaceuticals, waste disposal and emergency procedures L Method of Instruction: l Instruction will be both formal and didatic and individual as needed. It L will include but not be limited to personnel monitoring programs, ALARA, rules for safe use of radiopharmaceuticals, emergency procedures, a floor plan showing areas of use and storage and a tour of the facility. Method of Evaluation: Evaluation will be by the RSO or his/her agent and will be informal by actual observation of the individuals work activities.

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APPUCATION FOR MATERIAL UCENSE .FACIL'ITIES-SHIELDING OF THE RADI0 ISOTOPE STORAGE AREA' Lead Brick Storage Shield U. ~.

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Configuration i /..,. A 2 r,$th.O '. *. Front View of .. ;.. ' ' l..* ' ', Configuration $.: '. '; b,'. 2 .: < b, ' *-.:la,

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, a. Bricks Used: 4-- 2x4x8 .: t... '.... "b..,* .b.'*

4. gx4xs

= n a-a. ' Location of Table Top Shield and Lead Brick Storage Shield:on Table WALL-REAR OF TABLE TOP l

y. storage g{-l f,. -

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position of table. :'. L top ahield 'ib*.'. Y~ '.D.i"'..* *. * ' ';- 7-....._. b h. TABLE TOP (SURFACE) W.*.*uS:%C1ntlc. 2 J L Note: Very low level waste of short lived radiopharmaceuticals will be stored below the table, under the shield. Current waste, ie un-used 99mTc and 201'T1, will be stored in the lead storage con-tainer on the table, behind the shield.

w APPUCATION FOR MATERIAL UCENSE - FACILITIES-TABLE TOP BARRIER SHIELD Table Top Lead Barrier Shield E - Protect head and bodyfrom radiation when working with radioactive material. MINI TABLE TOP SHIELD for small jobs in limited working areas. ' STANDARD TABLE TOP SHIELD for all soutine work requiring protection against exposure to radiation. ~~ Select the shield most sulted to your workload. Both units . provide exceptional protection to the clinician when setting up: technetium ' generators, filing syringes, performing radiumloading procedunes,etc. %" thick lead wall protects the torso while the base provides 'N Emple working surface and balance against tippin0. Face M shleiding is optically clear %" thick lead glass (1 or 2 pieces - may be specified when ordering), cantilevered for unim-paired viewing or work area. The lead equivalent of each thickness of glass is 2.00mm. Both units can, be moved with little effort to any conven-knt location, allowing total flexibility in choice of work area. b so' w I I N N l l " n'd STANDARD MINI TABLE TOP TABLE TOP SHIELD U.' SHIELD so-ic 1 k / k,,. / m A m 4

~ APPUCATION FOR MATERIAL LICENSE D EQUIPMENT-QUALITY CONTROL PHANTOMS Also, see the source listed in this application under " Sealed Sources" EMISSION PHANTOM Extra Large Flood Phantom Source

15" diameter pool will totally include a patient's 1-lungs, allowing accurate patient position when using a diverging collimator.

L

16%'.' x 16%" 1" thick with 15" diameter x %"

t cavity for suitable radionuclide.

Easy to fill... drain ports provided.

TRANSMISSION PHANTOM l / 3 / \\' I i h . Standard High Resolution Bar Phantom m

3ar Widths: %" 8he". Stu"and %"

-) (6.35 mm,4.77 mm,3.97 mm,3.18 mm)

15" field across bar configurations (36.1 cm) l l

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APPUCATION FOR MATERIAL LICENSE FACILITIE3-RADIATION SAFETY EQUIPMENT Lead Lined Storage Container either %" or %" thickness, was For Contaminated Syringes This lead shield, available in designed to permit safe, conve-e Safely holds used hot syriW nient handling of vials containing liquid radioisotopes. It is par.

Rapid, safe disposal -

ticularly important when milking . ^,~ " cows". The vial provided with the generator may be placed in' the shield, and the generator sluted in accordance with the - g manufacturer's instructions, The shield has a high density e Itad glass panel, with shielding t l thickness equivalent to that of %" Thick - the lead wall, so that the entire process may be viewed, The shield has a screw type cover with an opening through which a syringe needle may be inserted for withdrawal of the radioisotope from the vial, 'N Pro Tec* Syringe Shield f

5. A g

.4

'i Pro-Tec Syringe Shields are the first functional, safe, unobtru-sive, easy to use, unbreakable, and lightweight synnge shields available. The thmhne design is comfortable for both patient SPEClRCATIONS: and chnician. The patented spnng loaded. twist lock or the stainless steel and braw screw lock keep disposable synnges %, W M ng snug inskje the shield. Pro-Tec Synnge Shiekis are hatt the weight of other synnge shields, yet the Pro-Tec will nominany hisesures: 6V high reduce exposure from som Tc by a factor of 20. The standard 5' diameter models are used by loading the synnge outside the shield. The Weight: 7lbs Pro-Tec Vu-Thru has a viewing port, so that drawing and injecting can be accomphshed with the synnge in the shield A special optical glass winaow with a density of 2.3 gm/cc covers the port. Lead Shielded i ~ The VU-THRU I Syringe Holder For syringes that radioisotopes. Ac-F ti D disposable synnges (twistiock) vs. pet es.szo.sai Commodates syringes up to SCC, or a syringe in a PRO TEC shield. En-tire unit is sheathed in steel. Large l diameter base prevents toppling, ideal for safe storage and transport of syringes. VU THRU(Glass) k=. 007 303 Pro-Tec Synnge Sn eid 3cc SPECIFICATIONS: 007 505 Pro-Tec Synnge Sn.eid 5cc Height: 6.5" Weight: 6 lbs l

' APPUCATION FOR MATERIAL UCENSE Attachment F. RADIATION DETECTION INSTRUMENTATION Instrument Supplier /Model Use Gamma Camera-NCSystems-GE/Siemens* Nuclear-Cardiology Image and Function Nuclear Medical-Computer. NCSystems-ADAC/GE/Siemens* Data Analysis and Presentation Dose Calibrator Capintec CRC-7 or AccuCal Calibration-and 2002 Quality Control Survey Meter PUG-1.or Ludlum Model 14C Surveys and Spill control as well as personnel contamin-ation monitoring Film Badges-Body Landauer** Whole Body Personnel monitoring of all individuals who work with or arround sour-ces or patients.who contain radiopharm-aceuticals Finger TLD Dosimeters Landauer** Personnel monitoring of all personnel. who handle sources or. patients contain-L ing radiopharmaceut- [-- icals. l

The specific system has not been determined but the use of the system L

.will not change this application or. the operational contitions of the L resulting license granted. 'l -Note: See the following.pages for descriptions of the equipment de-l scribed.above. l }

- These are described in the " Personnel Monitoring Program and ALARA

-l section of this application and they will be changed on a monthly basis, at the' start of each month. 1 l \\ l l i i-l l l { ,e <w- +

~ l > APPLICATION FOR MATERIAL LICENSE .e l' . RADIATION' DETECTION INSTRUMENTATION-SVRVEY METERS ~ Universal Portable Monitor and Survey Meter + FOR ALPHA-BETA GAMMA LEVELS 4, e 3 ranges i

Selection of Geiger and scintillation probes g
Aurel and meter radiation inoicators e Battery operated ("D" cells only)

'

One-hand operation The PUG-1 is a portable universal Geiger / Scintillation ts -

Survey meter for alpha, beta, gamma and neutron PUG 1 survey and monitoring. A selection of probes offers - Monitor virtually unlimited versatility in measuring radiation levels. A convenient probe mount on the side of the unit permits attachment of the probe to the instrument A panel switch permits rapid change of ranges (0-500, body for single-hand operation. 0 5000, 0 50,000 cpm plus battery check). Cahbra-The bold-numbered 4" meter offers excellent read-tion is a simple screwdriver adjustment, specifications ability. Readout is in cpm, however transparent mR/hr cards are supplied to clip over the meter face so that Rensee: Fixed meter f ace 0-500. 0-5000. 0-50.000 cpm Caherated

- ""P"'d """#" E' D' radiation levels may be read simultaneously with any conwe n-o f probe. The aural indicator is controlled manually by n o,t, range selector, banery eneca.canbrate. speaker an off on switch and responds to radiation intensity-speaker: volume controned Pulse input is zener diode protected so that the probes Prote conneesono: DNC fow noise teflon insulated may be Interchanged without shutting off the instru-g,m 7 n,,,.g.,,,,,

ment. All probes are interchangeable. Each has its 082100 PUG 1 Portable Monitor own meter face card. GElGER PROBES 062 170 ALPHA / BETA / GAMMA "EndWindow" Ge10er Probe.. Most popufar probe for general use. This probe. which incorporates a 1.4 mg'em8 end window GM tube, is ideal for detecting alpha and sof t beta radiation not detectable with side-window probe. Includes extra meter face P 6 \\ Range:O to.3 mR/hr On low range

APPUCATION FOR MATERIAL UCENSE if RADIATION DETECTION INSTRUMENTATION-SURVEY METERS Ludlum Model 14C .nCmiC* Tion: gW Audio: Built in unim;rph speaker with ONIOFF switch. Response: Toggle switch f or FAST (3 seconds) or "' # I " *** " *I ' ' ' " ****'"8'

Alpha /BetalGamma Geiger Counter
One Internal Range: 0 2,000 mR/hr Roset: Push button to zero meter after over range exposure.

Meter: 0 2 mR/hr linear,0 2 mRlhr non imear for 2,000 mR/hr

Four External Ranges: 0 200 mR/hr scale, and BAT OK.
Includes External & Intemal Probe

'fo',,",*nDieibr*.t * ' '

n Batteries: 2 each, "O" cell with 200 hours typical hf e.

Detector: .l Internal For high range Gamma detection only; 200 nR/rh External Model 44 7; 1.7 s 0.3 mg/cm' mica end window, 6.4 cm' active window area. t ' Alpha Etticiency 30% Seta Etticiency 10% for C 14,45% for Sr.90 ( Gamma Ettsciency 1700 CPM /mRfhr for Cs 137 j J Construction: Cast and drawn aluminum with beige ~ polyurethane paint fmish. Size: 3 4" W x 6" H x 7" L. (8.6 cm x 15.5 cm x 17.8 cm) The Model 054 014 Geiger Counter is a portable, self-Weight: 3.6 les. (1.6 kg.) contained instrument with five counting scales. The first four counting scales are connected to an external detector and the fif th scale (X 1,000) is connected to an internal detector, Two "D" cell flashlight batteries wiil operate the unit, including the speaker, for 2,000 hours. The meter is housed in a rugged, cast aluminum bezel, sealed with "O" rings. Any GM probe offered will operate as well as any scintillator probes offered. Ad- ~ justable high voltage is provided. Gamma Check Source This disc type is preferable with standard flat faced crystals.(No Uconee Necessary) 101 103 Uncallbrated "'Cs Disc Source, 10uCl.1" D x %" thick.

i APPUCATBON POR MATERIAL UCENSE RADI ATION DETECTION INSTRUMENTATION-DOSE CALIBRATOR ' l CRC 7 Dose Calibrator l e Pushinsttonlootope selector e Fully shielded charnber I

Four d19tt LED roedout
21% sepeataldlity

= Eaerto operate = Totally asseMable i INCLUDES:' asSteo vielcepper 088 841 Wellbeert 086433 blely Shiehl r Vl 'l 'i 'l'l '] gy -a. weei,iCAfios. Goatsotten teammar Design-Inteersted deep een, ifWn won,

80n eMisewe. ereen gas tweed caemeer et se leews estag useush tente the caNsetor to mainteisief l.

AeNehy hasqpx.01eCl to 79I8 MCI. unser senseant temperates, lineelsey, ens sedelten esadessen Wee nk"=* 10" M a 2.5" O teengrouns eensnene ens e W ee se M i (N em a e can. Peoer ^ 12 VAC 9 OSA D182 l Olghel Roadmet Few east, essen segment LED esosey utth or See VM e SO 08HOOI ) lleetmg seesnel poet. Romeout sccwecy e 0.1% of readen0, Psequener W er 80 Ms. i e 02% of full esess. a 1 en test seest. Innsgneasse 17" M tueth ehemees) a 12%" W 18" 0 Octester Linearler a 1% for 2 Ci of Tc4ern. $ss em a N em a et eng h Linesser a 1% Wolget e8 lee. 314 nok - h Asemeer a 2%, esempt a 3% en the tuca to soo sca renee. Reseisane flem Tyoteesy teos then to essende to N% of Mte knee W tmien tete "Aseregang Pened" ennen to an tete " tong" esenen,9% of the finea feasing as femened in toes then 2 escenet Oseres Accesser coereil ensureey of tese cedereter as deter-enened oy tne acewesy of the spectfac eeures, eengrateen ec-i }- eurecy, eclector eneerity, electromoeor escaveey and feedeut o acewecy. RepeatellWir Within tite seesthed ses IIIenth sellersteen Irq> i tervel, all meesweniente WH4 feH enthm the tesorenees heled eeove ettesurGntente Will repeat to u4ne a t% for e ported I ac l

1 J APPUCATioN POR MATEMAL UCEftSE ) 4 RADIATION DETECTION INSTRUMENTATION-DOSE CALIBRATOR l AoonDal f9028080100808ns i fMunenesens seegnt Ceneese 1.6 les(5.8 egi attMtees tietow 200.Cl een Cnemeser ang sneese. 0 a estes. r.pneese 10.3 * (25 8 cmlienteth. 69 a les(27 Rei I 8 2' 00 7 cm> weem. son Censunter-esermeteceer seesee. I a l'(10.9 cminseprit tocation memott up to 9-(3 mi pressortsee argen gas. 4en Chemiser. ita tal 2 cminsegnt. een Cnember Seas 30cvInstteryIrvltlADY t 8'E219 cmasuteese se95 or 8elDA *?!!t Accurety-tassonne nernisesse at eWnist#' cme weit 2 l ' 46 6 power: tile AC s 10v AC: Co" One Co"nerates to artenm i 1% seHe l sioniste'c. fl0VACs PovAC: toortes coactusme i 10 a* (24 ml1 rett esoth. 60'40 set. 2Sw imaa a gepeces:He seestet well uncerteenty tiestee Dy seest loner 6ncluee0 Rossense veme: Lees then i escones for activitees esove 300.Cs tWeenty Lees than a 1% nom Sneesetn0 OnHMet t %' 40.8 cme 09 6 estet. eineatity sue to recemoe-steet outer sneelworn %* Leesinevi 5 escones for nation envets up to 2000 to 6 cmiesse swune seas. acteyttees between met (14 Desi9 erit am. tegnes erternet esse 200.c40 a estet one test then a 2% beteveen eneesing willnot aneet Doo.Cl(29 6 asset. 2000 mcs 04 Ote> ano ca80tpretton. toes tnen 10 escones for 5000 enCI(185 Otes. l hod t* l w = tes.,or. k' l GCDI j to ti M esen l f .~ f I

Jllll,%

i i s ] $l

D g

L l M C ') v v ten Csesseer-Cnerge Convero6en Seesesy: tuntom a sapet. 9 se0-j testeuene of een Cnessthers: mentl#Gue0 crystal. l Isome. rms s 0 2.tt(0.01 essai Accurary: e 0.5% peus 18 get, fun CentrolUnst: 240 metreprocessor for1c m ernen s l menea"over ic u eter. range acomery 2aaans,52 arate eyvisaeces 20xpeos. ._ cius. unurity Ow.eun scene. Int reesteen stetsstecal Date Sumeft: 85 252 Seral Dort. Onep-fluctuateenst sessee rms s iInstt, tuliscese. nootst ans remote mes= momenen StooNety Leal then i 9% W SteDelery. tenort termi e 01% Wrm Wettueeng r30ea. ,e,n,out.2000. Clos estes ggg,e,,e,rs,,,, e,se,u,t,i,ete,,r,,,,, teen 3g,, g hu"tuer tiene terma 3 0.$% full ^^i-1 i-Dreek-e back-l D'**'a casasat i% eor eteMt. meese foo0.Cipanenei l assolution. 01.Clon 200.ClO a estas IMus 5 espots on the eyeeseist toov oc enestusepy canne 200.ti(1 a scheirense L N5 252 tortes sort e SYSTEM SELFTEST e USER PROGRAMMABLE RADIONUCLIDE SELECTION ISYS e REMOTE WELLTYPE 10N CHAMSER e AUTORAN0lNO e LED PUNCTION IDENTIFICATION

MEASUREMENT ON CURIE OR j..
DISPLAY RANCE: 0,1pCl. 4999mCl BECOUEREL SCALE l

l

r APPUCATON POR MATERIAL UCENat Attaehment G. PROCEDURE FOR CALIBRATION OF THE SURVEY INSTRUMENT The applicant will not calibrate the survey instrument but will have a contractor do the calibration on an annual basis or after any repair other than the replacement of the batteries. The procedure for obtain-ing this calibration will be:

1) The contractor selected will have a NRC or Agreement State license

[ to perform calibrations and this license will be documentated by the applicant prior to contracting this service. It is anticipated that l the calibration will be done by the manufacturer of the instrument or by Eberline Instrument Corporation of both 312 Miami Street in West Columbia. SC (1800-234-4212) and 504 Ariport Road in Santa Fe, New Mexico ( 800-274-4212) or KNS Associates. Inc. or 1854 Airlane Drive in Hashv111e TN 37210 (615-883-9760) License # R-1975-C1.

2) If a contractor remote from the location of the facility is used, either a repa1 cement survey meter will be obtained during the cali-bration or the facility will not operate during the time the system is not present.

3) Upon receipt of the instrument from calibration, the applicant will check its apparent rate of exposure with a built-in or independent check source license exempt, and note that level of exposure on the survey meter.

Prior to each operation, the instrument will be check ed to determine that the reading is still the same indicating the instrument is still in calibration.

4) The report of survey meter calibration, obtained f rom the contractor after calibration, will include but not be limited to, the follow-ing information:Identification Of Who Did The Calibration Their License Number The Name of The Owner Of The Instrument Description Of The Instrument Manufacturer Model Number Serial Number Type Of Detector A Description Of The Calibration Source &

r Its Exposure Rate On A Specific Date E The Calibration Procedure l For Each Calibration Point The l Calculated Exposure Rate Indicated Exposure Rate L Duduced Correction Factor l Scale Selected The Reading Indicated By The Battery-Check The Angle Between The Flux Field & Detector The Position Of The Detector & Its Shield The Apparent Exposure Rate From The Check Source The Name Of The Person Performing The Calibration

APPUCATION POR MATERIAL UCENSE i S) The following information will be attached to the instrument as a calibration sticker or tag: The Source That Was Used Proper Deflection In The Battery-Check Mode For Each Scale or Decade. One Of The Following The Average Correction Factor A Gra,ph Or Graphs From Which The Calibration Factor For Each Scale or Decade May Be Duced or An Indication That The Scale Was Checked For Fucction But Not Calibrated Or That The Scale Was Inoperative The Angle Between The Radiation Flux And The Detector The Apparent Exposure Rate From The Check Source

6) The form, below, will be used to document the meters calibration and service.

l SURVEY INSTRUMENT CAUBRADON AND SERVICE RECORD Winetw 5: Mlp.: , M00e4: Protes: mg/cma St. 9dumtier; Check Source: leolope: Cohtwatson: Actw W Esposure Role: mfVhr 1 instrumentCettwahore Does: ty: Date Twsie Source, mR/hr Asuon h Dy ) 4

Cahtwelion Inuet tie rio less then annual and eher each DeMoeng that involves more then repiscement of the tieneries.

@ Cesyviges test NCDyesnis Wm.,30119masser hausser. CD sour hennel oness $4e44am oct M or 3094410a3

=- l APPUCATION POR MATERIAL UCENSE Attachment H. PROCEDURE FOR CALIBRATION AND QUALITY CONTROL OF THE DOSE CALIBRATOR The applicant will implement the following procedures on the dose cali-brator. 6

1) Geometry Dependence-Geometry dependence will be determined at the time of installation and will be no greater than +/- 5% with the types of containers used by:.the applicant.

The procedure for meas-urement of geometry dependence is: a) A syringe o,f the type used for routine procedures will be filled with 5cc of 99mTc containing 1-10 mci of 99mTc. b) The syringe will be " counted" in the dose calibrator in the same way that patient dose's are measured. c) An additional.5cc of water will be drawn into the syringe and it will again be " counted" as in b) above, d) The procedure will be repeated untill there is no less than 2.0cc in the syringe + e) Selecting the volume closest to that normally used for pat-1ents as the " standard", divide the mil 11 curies indicated by each of the other volumes into the standard to determine the volume correction factors. f) If any of the correction factors are greater than 1.05 or less l than 0.95, it will be necessary to make a correction table for the calibrator showing indicated activity at that volume vs true activity at that volume. L Geometry Dependence l Date: Calibrator:Model: Serial # Activity used: mci Measurement By: L Volume', cc Activity Indicated, mci Correction Factor

2) Accuracy-Accuracy will be determined at the time of installation I

and not less than annually thereafter and the accuracy must be with-l in +/- 5%. The procedure to measure the accuracy is: l a) The calibrated reference sources of 57Co, 133Ba and 137.Cs as authorized under this license will be used for this pro-l cedure (see " sealed sources"). These sources are to be ob-l tained with calibration certificates that are traced to the NBS by the source supplier. b) Each source will be " counted" at its correct setting on the calibrator, background on that setting subtracted, and the activity recorded. This procedure will be repeated for three measurements of each of,the trhee sources. c) The average of the three readings, of each source, will be made and divided into certified activity of the source after corrected for decay. -,. +, - ~

n APPUCATMN POR MATERIAL UCENM d) The results of the caluclations, section c) must fall within the range of 1.05 and 0.95 (to fit within +/-5%. It it does no.t f all within this range, repair or recalibration should be considered however. if it exceeds 1.10 and.90 (a +/-10% range) repair, recalibration or repa1 cement must be made. i e) Because these same sources will be used for the daily const-ancy tests, the 57C0 source will also be used to measure the reading on both the'5700 setting and the 20171 setting dur-ing the accuracy measurement. f) A Sticker.will be placed on the Dose Calibrator indicating when the next accuracy test is due. Accuracy Date: Calibrator:Model: Serial # Source Accuracy Deviation Notes mri of mC1 SN#: mci I Calibration date: mci Av: mci mci of mci s SNt: mci / Calibration date: mC1 Av: mci mci of mci 5Nt: mci / Calibration date: mci Av: mci

3) Linearity-Linearity will be determined at the time of installation and not less than quarterly thereafter and the linearity must be within +/- 5%.

The procedure to measure linearity is: a) A syringe containing not less than 50 mci of 99mTc will be obtained f rom the radiopharmacy. b) The syringe will be " counted" in the dose calibrator at the earliest time in the morning, i.e. 8:00 am and the mci indi-cated, minus background, will be recorded. c) The syringe will be counted again at not less than three times during the day during a 9 hour period of time. The readings will be recorded, minus background. d) The values obtained will be indicated on semi-log graph paper and the best-fit line drawn through the values. A second-line will be drawn through the expected points as calculated using decay factors of the expired time, e) The maximum deviation of the observed line from the calculat-ed line will be determined. If the deviation is more than +/- 5% (0.05) the instrument will be adjucted or repaired. If it can not be adjusted or repaired, a correction table or graph that will allow conversion from activity indicated to true activity will be made and placed on the calibrator.

APPUCATION POR MATERIAL UCENSE I Li nea ri ty Date: Calibrator:Model: Serial # Source: mci of 99mTc in ec 9 am Time Assay Bkg Activity Activity Hour Elapsed Observed Expected mci mci mci mci mci mci mC1 mci mci mci 100 . -.- -. n~ s ~. - - - ... ~-- m-. ,mr-... a u rs a. - e.. ..w:. nxaw.. h 1- !g ;' s igp!:: E==. E :sf f E e-E 2. e n gh.i. 5:44:.-

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== W ,= a _ m __ = __ _ = ' c .= 50 .;anm.. - - , p g.. ,a 40 = ~ ~w.w=ms.wnwn~uun w a wm a,=v:+=~. 2:%#E E E $ ? Ei ?E EE E h 45k? % Ek5f EEEEE E E55 E REnnE EMEEEEE E EE EW555EEEER FEEEEE$ENR i $$E5$$$55!$5$!.55NEbh!N$ E$b$$b!$bb5N !b!b$bE$Nbbbbb55b5EEhh5bhE!IbbbSb L 20 EEMEEEEEEEEEEEEE55EEEEEEEEEE5EEEMEEEEEEEEEEEEEURISEEEEEEEEEEEERIEH

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APPUCATmN POR MATERIAL UCENSE

4) Constancy-The constancy of the readings from the dose calibrator will be measured at least once each day of radionuclide operation.

If no radioisotopes are received or used during the day, no operat-ions take place, then constancy will not be checked on that da l_ The constancy must be within +/- 5% of the anticipated value. y.The procedure to measure constancy will be: a) The 5700 sealed dose calibrator source will be measured on both the 201T1 and 5700 settings, t.. b) The background at the same settings wil'1 be recorded, e c) The acitivity indicated, at both settings, will be determined by subtracting the background, b) from the readings determined in a) and this value will be recorded. d) Action levels will be determined for the reading at each setting reflecting the range of +/- 5% of the anticipated reading. If the value is greater than +/- 5% the RSO will be notified and if it is 10% or greater from the expected value, the instrument will be repaired or replaced, e) Records will made of the above constancy measurement using the form shown below. DOSE CALBRATOR QUAUTY CONTROL AND PERPORMANCE RBCORD i Does h m " SeatedOCSources teosope Cal Appvey Geometry ha.:..2: Date

+/-

% (+ /- 2% hmetr mci Armuel Accuracyleet: Does

+/-

% (+ /- 6% hmitr ~ MCI Quarterty Linearnr -Does .=/- % (= /- 6% hmetr mci Queety Comrol .m C-a e,Cnect Dess T6me Actrvity 57 Co tri cs 133as Dy l 9 ecas,=iseseeie ame ,.n coamme on mmes.rtto,am ion

4 APPUCATMN POR MATERLAL UCENSE

5) After repair, adjustment or relocation of the dose calibrator, the tests established in 1)-4) will be repeated as may be appropriate.

6) On a qubrterly basis, the applicant will determine that the measure-ment chamber is in place and that the instrument is zeroed accord-ing to the manufacturer's instructions.

7) The RSO will review and sign the records of all geometry, linearity and accuracy tests.

8) Records of all-activities performed on the dose calibrator will be make and maintained by the applicant.

9) The records, in addition to the records indicated in this applicat-ion, will be recorded on the " Dose Calibrator Quality Control And Performance Record Form".

This form has room for the optional con-stancy check with sources other than 570o which may also be done in the constancy check by the applicant but because only 99mTc and 201 T1 are to be used, the basic check will be done with 57Co. t

Attachment I. APPUCATION POR MATERIAL UCENSE PROCEDURE FOR QUALITY CONTROL OF THE GAMMA CAMERA The following procedure will be followed for quality control of the gamma camer.a system. The individual procedures may be modified as the clinical procedures evolve and experience with the system is acheived. Any such changes will be made only to establish evidence of the qual-ity of the clinical results and to enhance the reproduction of accurate images and functional information.

1) Prior to the use of the system for clinical studies the system will be deemed to meet'the specifications of the manufacturer including the uniformity, resolution, linearity(spacial) and its switches and interlocks are all operational as well as acceptable maximum count rate capacity and sufficient count rate linearity at 20% count rate loss.

2) Daily, the PHA will be adjusted, the spatial resolution determined and image quality evaluated.

3) Weekly, the maximum count rate capacity and flood field uniformity will be determined on the system.

4) Quarterly, a background flood, count rate linearity at 20% count rate loss and all interlocks and switches will be examined.

5) The operator of the system will be instructed to be aware, with each use of the system, of any changes in the electrical, mechanical or radiation detection performance of the system..

If any events are noted that are not expected, the operator will remove the patient from the machine and notify the RSO prior to continuing operation.

6) The " Gamma Camera Quality Control and Performance Record" and the

" Gamma Camera Incident and Service Record" will be used to document activities on the system. These documents are found on the next two (2) pages of this application. l

APPUCATION POR MATERIAL UCEZSE Procedure For Quality Control Of The Gamma Camera-Continued i I ill I l l I i I. il l, ( l .I i l I 1i-I j I i J i 1

APPUCATION POR MATERLAL UCENSE Procedure For Quality Control Of The Gamma Camera-Continued i E i 1 1 l 1 i I; ,i O. a,,! E ill a l I.i Im!, g ,8 l% tyl l r l l-i r 8 v 5 p ji I Jei i J l

APPUCATION FOR MATERIAL UCENSE Attachment J. PERSONNEL EXTERNAL EXPOSURE MONITORING PROGRAM Our Personnel Exposure Monitoring Program will include but not be limited to the following activities:

1) The RSO will promptly review all exposure reports and look for any workers or groups of workers whose exposure is unexpectedly _high or low.

2) All individuals who are occupa'tionally exposed to ionizing photon radiation on a regu.alr basis will be issued a whole body film badge and it will be processed by a contract service on a monthly basis.

3) All individuals who, on a regular basis, handle radioactive material that emits ionizing photons will be issued a TLD finger monitor that will be processed by a contract service on a monthly basis.

4) Other individuals who are exposed to radiation on an occasional basis such as security personnel who deliver packages, secretarial personnel and nurses who may care for patients containing diagnostic quantities of radiopharmaceuticals will not normally be issued dosimeters.

If they are issued a dosimeter for measurement of their expsoure, if it is deemed necessary by the RSO, the whole body dosimeter will be is-ssued for 3 months.

5) All monthly personnel dosimeter reports will be posted for all of the workers to read and to note on the report that they read the report.

RADIATION SAFETY COMMITTEE The applicant will not establish a Radiation Safety Committee because this is a private office and not a hospital and thus no such committee is possible. The RSO will, however, carryout the activities as are es-tablished in 35.21, 35.22, and 36.23 of the CFR and the Model Radiation Safety Committee Charter and Radiation Safety Officer Delegation of Au-thority under the Appendix F of the Regulatory Gyide 10.8, Rev.2, NRC. ALARA PROGRAM The applicant will establish an ALARA program as established in Appen-dix G to the Regularory Guide 10.8 Rev.2, NRC with the exception that there will be no Radiation Safety Committee and the entire application of the ALARA concept will be done in a more informal basis by the RSO. The key elements of this program will be:

1) Commitment to keeping individual and collective doses as low as is reasonably achievable and

2) A ongoing review of the radiation safey program with a more formal review on not less than an annual basis and

3) Modifications of the radiation safety program, incuding equipment and procedures if they will reduce personnel exposure and

4) Establishment of " Investigational Levels" below the applicable limit as stated in page 2. of this section and

5) Provision of routine reviews by the RSO of the safety program (annual),

occupational exposures (quarterly & monthly) and radiation surveys (monthly) and

6) Cooperation with workers in reduction of exposures and

7) An educational program for all workers on radiation saf tey(see the

" Training Program")

a m. -4s. Aa2 A. d 4 hL ~,. ha + + s ws.am ei^* A-ss---a -<amA-w,-s-s4am A. e 'I L RADIATION SAFETY AND QUALITY CONTROL SCHEDULE TABLE L tj 1 lil.ul.muu!!IIIIIlal 1 11 1111111 i i i ! u it l ll! ~ _g ll1 o n[ _il is !l ll r li; ll.,____ pj 11* s, fIf n1 lgl ! $8 f i i

~ APPUCATioN PoM MATERIAL UCENSE ALARA PROGRAM-POSTING OF NOTICE AND EVALUATION OF DOSIMETERS The following notices will be posted. larger than indicated below, L at.the location of the film badge, whole body, reports. i 1 l ALARA Aslow As Reasonably Achievable Can You Lower Your Exposure? l This faclRty is dedicated to maintaining all occupational exposures at the lowest level that can be achieved. Please tell the Radiation Safety Officer (RSO) of any ideas that you may have for lowering exposures and be aware of your work activities that can reduce your exposure. Let's get everyone into LevelI, t> caprism 1ess Nesvuams. inc.,scm emesmer howeso,co sosce e.menei onces m e r' eat M = 3ow44-1043 NOTICE TO ALL RADIATION WORKERS This notice e to be posted with the personnel answneuy se,aa*t Piosee revow the personnel doelmstryinformation on the dosimeter report. Note any exposure levels that are lower or higher than would be expected. As a lecihty commmed to maintaining occupational radiaten exposure As low As Acasonably Achievable (ALARA), we have establehod levels of exposure lower than those establehod by current regulations. Picase compere your current levels to those given in the following table. Aseeptable Lavoie of Radiation B rea=u e (mRome) Levell Loveill Lovef ilf* month 13 weets month 13 weets month 13 weeks Whole Body, head and trunk, 42 125 125 375 417 1,250 blood formme orpens. lens of eyes or gonads Hands endlorearms. loot $25 1,875 1,875 5.825 4.250 18,750 and er.kles Skin of whole body due to 250 750 750 2.250 2.500 7,750 belaesposure Vrom The 10, Part 20.101(a) Ahor revowing the current report, please contact the Radiaten Saloty Offcer if you have any suggestens on how your exposure may be reduced, Also contact the Redetion Salety Offcer if your exposure status has changed or may change. Th6s includes changes in your activeses, types of procedures or ter.hniques. Please immodeseh contact the Radetoon Safety Offcorif you are pregnant Ahor revowing the report, piosse initial the report next to your name to indicate your review. NOTE: This report has been revowed by the Redeten Safety Offcer and if areas of concem have been noted, you will be contacted for a safety revow. c copromiseswesrewms.inc., son mese y.nouww.coaosor ses ne' onces saaner4cowat m,sous4. ions See the next page for the posting of other notices related to ALARA and'the. Radiation Safety of the facility.

APPUCATION FOR MATERLAL UCENSE l ALARA PROGRAM / EMERGENCY NOTIFICATION-POSTING OF NOTICES The following notices will be posted larger than indicated below and complete with the required information which can not be obtained until a license is issued and the facility is implemented, at the entrance to the room where radioactive materials are used and in the radioiso-tope storage and manipulation area of that room and the " Notice to Workers" will be also posted on the employee notice board for all work-ers to see. NOTICE TO WORKERS This facility operates under a medical radioactive materials Econse. The license, its application, documents incorporated into the Ecense by reference, license conditions and any amendments, operational proce-dures and al related materials and communication can be examined by contacting the individual Ested below. License Number: Issued:

Contact:

Telephone: e c,, -,c. e co.,,_, o..e. _. ,,0. _, NOTICE Radioactive materials may be located within this room and, if present, their location is clearly identified by the radiation symbol and the words " Caution Radioactive Materials." in case of any emergency involving this room or the materials herein, contact the Radiation Safety Officer, RSO, as listed below.

Contact:

Telephone: c caprnre test NC$yuman Dr. 011 bromeney, toutew, CO 90,02 Namns onces te e ri.rt to a N1643

i APPUCATION POR MATERIAL UCENSE Attachment K. l LEAK TESTING OF SEALED SOURCES The procedure.for the leak testing of the sealed sources requested in this application is given below. It will be done every 6 months. 1) A list of all sources to be leak tested will be made. It will in-clude the following information: a) radioisotope b) activity.at a specific date c) the physical form i 2) Each source will be wiped, " swiped" with a cotton swab using caution to not touch the source except with the swab and keeping the source i shielded as much'of the time as possible. Each swab will be identi- ) fied to know which source was tested and caution will bc used to as-sure that the operator will not become contaminated with the swab or source and that the swabs will not be cross contaminated. 3) Count the " swipe swabs" with the GM survey meter to determine if any counts, activity indication is present after counting a gamma j reference source of 133Ba or 1370s under the same conditions to de-termine the operation of the system and sensitivity of its detection. 4) If no swipe-swab counts are present, above background, record all information as cpm and note that the leak testing was completed on the container of each source. If swipe-swab counts are present, calculate the mci present using the cpm / mci determined from the re-ference source. (These are the same calculations as are performed in the Removable Contamination Survey). j 5) If the swipe-swab activity is 0.005mC1 or more the RSO will be noti-fied, the source withdrawn from use and repaired, replaced or it must be discarded according to the Waste Disposal Procedures. ) Sample Record Form For Wipe Testing Of Sealed Sources Date Time By Assey: Date Time By SAMPLE ANALYSIS Sk0 Not UCI Radioactive Material Swipe Gross cpm " cpm * ~15F " "Ci Action Taken ~ isotope l Activity l Form cpm 137 Cs 133 Ba 57 W l. II. STANDARD ANALYSIS A. AssayuCi x Decay Factor = uCI - B. Gross cpm - Ske cpm = Not gm _ h C. Calibration Factor A/C = Instrument: Standard: Radionuclide Assay: Activity Date

~ l APPUCATION FOR MATERIAL UCENSE NOTES ON ABSOLUTE COUNTING FOR CONTAMINATION, SPILLS AND SEALED SOURCES Reference Sources The. reference sources used for absolute counting analysis to convert epm to dpm or cpm to uCi and to assure the sensitivity of the detector, are lecense exempt thus.are not part of this application. These source! will be of 133Ba or 137Cs and will be obtained from NEN/DuPont of North Billerica, MA. 01862. These sources are registered with the USNRC or i BRH/FDA, according t'o NEN, and are NBS traceable with the error analy-sys calcualted following the format of the recommendations of the Inter national Commission on Radiation Units and Measurements. Report 12. Each source has a certificate of radioactivity calibration from NEM. Each-source will be of 0.luCi calibrated to +/- 3-5% accuracy. These sources can be expected to produce, with the GM survey detector system, more than 2,220 cpm per 0.luci or 111 cpm /0.005uC1. even if the effic-iency of the system is only 1%. This efficency would produce 0.01 dpm per epm for counting contamination swipes from routine surveys and from radioactive spills. Documentation of Wipe Testing Each sealed source wipe tested will be identified with a label or tag indicating the following information: Wipe Testing Completed Date Operator This source was wipe tested on the above date and analysis of the sample indicated uCi of rem-ovable contamination which meets the requirements as establsihed under this license. If the sealed source does not meet the requirements as established un-der the license, more that 0.005 uCi of activity can be removed, the source will be removed from service and labeled with the following in-formation: Leaking Source-Do Not Use Date Operator This source was wipe tested on the above date and analysis of the sample indicated uCi of re-movable contamination which does not meet the require-ments as established under this license. This source MUST NOT BE USED UNDER ANY CONDITIONS UNTIL CERTIFIED AS REPAIRED OR RENDERED SAFE BY THE RADIATION SAFETY OFFICER. If you have questions call

f APPUCATION FOR MATERIAL UCENSE At%achment L, RULES FOR THE SAFE USE OF RADI0 PHARMACEUTICALS The " Notice".shown below will be the procudure for the safe use of radiopharmaceuticals in this facility. This procedure will be posted, in a larger form, in the room where radiopharmaceuticals are used. I NOTICE RULES FOR THE SAFE USE OF RADIOPHARMACEUTICALS

1. Road and understand the license,its applicaten and all documents related to the 16 cones and its operating condatens.

2, Only authorized personnel are allowed to use radopharmaceuticals and only in thoes ways that are authortred by the license.

3. Personnel dos 6 meters, body film badges, must be wom in the area where redopharmaceuticals are being f

i stored, prepared or used and when the radiaton worker attends patients containing radopharmaceutcals.

4. Finger dosimeters, TLo's, must be worn during the preparation, assay and administration of redopharma-coutcals and when holding patients during nuclear procedures.

6. laboratory coats or other protective clothing must be wom at all times when in areas where redeactie materials are stored or used.

6, Deposable gloves must be wom at all times while handling radcactive materials including administration to the patients.

7. Use sheided containers or tongs when handling sources and never touch the sources with your hands.

8. Never pipette any materials, radcoctive or non-radcactive, by mouth.

9. Do not store food, drink or pornonal eftsets in areas where radioactive material is stored or used.

10, Do not eat, drink, smoke or apply cosmetics in any area where the radioactive material is stored or used.

11. All radcoctive materials must be kept in shielded containers, including sealed sources, syringes and active waste. All containers will be clearty labeled with the name of the redonuchde, form, date and actMty.

12. Use synnge shields for preparation and administration of patient doses.

13. Assay each patient dosage in the dose calibrator before administration to assure it is within 10% of the prescribed activity. If not withm 10% do not administer the radiopharmaceutcal.

14. Piece radioactive waste only in tne designated, labeled and property shielded receptacles. Do not drspose of radioactive materials in any other manner.

15. Use a cart, wheelchair or tray to move all redcactive materials and never leave them unattended.

16. Pr6er to administration of the patient dosage, complete all radiopharmaceutical Quality control procedures and records. Check the patient's name and identifcation, the requested procedure and redopharmaceutcal.

Check lor any technical or medcel contraconsadoratens. j

17. Use great care to avoid contamination during the preparation, administration or disposal of the radioactive material. Use equal care to avoid any contact with the patent's blood or body fluids.

16. After each procedure or before leaving the radioactive materials area, monitor your hands and clothing for contammaten.

19, Monitor, at the end of each working day, with the low range of the GM survey motor, the preparation and administration areas for contamination. If contamination is found, notify the Radetion Safety Offcer and decontaminate or escure the area for decay.

20. Survey, at the end of each week in which redcoctive materials were received, manipulated or used, by wipe test (wipe, smear or swipe), all radcactive material storage, preparation and administration arest for contamination, if contamination is found, notify the Radiation Salsty Oificer and decontaminate or secure the area for decay.

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m ucanon a m m uc== RADI0 PHARMACEUTICAL CONTROL NOTICES R: J:l ' ;4"' " " * " "' " ""' " " " ""' "' ""' ~ '"" * * ' j RADIOPHARMACEUTICAL RECEIPT AREA Place All Packages Here RECEIPT OF PACKAGES RADIOPHARMACEUTICALS TO BE RETURNED TO THE RADIOPHARMACY j DISPOSAL BY TRANSFER DO NOT EMPTY RADIOACTIVE WASTE MATERIALS DISPOSAL BY DIS

APPUCATION POR MATERIAL UCENSE Attachment M. PROCEDURE FOR SPILLS The following procedures for major

and minor
spills will be followed in our facility.

This procedure will be posted, in larger form, and it will be useil in the employee training program as indicated in that sect-ion. NOTICE SPLL PROCEDURE W40R SPLLS

1. Notify all persons in the area that a spill has occurred.

2. Provent the apread of the contaminehon by covenng the spill area with absortent paper and accure the tres.

3. Survey all personnel in the area to assure they are not contaminated. If contamination is present, decontaminale.

4. With the RSO or another person not involved in the spill doing the monhoring with the GM survey meter, determ6ne the marpms of the contaminated area for decontamination.

5. Clean up the spill using disposabio gloves, foot coverings if indicated, and absorbent paper. Remove the paper covering the area, r.leen side out, avoidmg contamtnation, and place in a plastic bag for transfer to the redcactive waste container. Clean the area, decontaminate, and place all wipes, papers and gloves in the bag for transfer to the waste container.

6. Ahor decontamination, aurvey the area with the GM aurvey meter. Include in the survey the area around the spill area. Oneck your hands, clothing and shoes for contamination.

7. Complete the " Radioactive Spill Report" and " Radioactive Spill Contamination Survey."

j

8. With the RSO, evaluate measures to be taken to prevent such spins.

MAJOR SPLI S

1. Clear the area by notifying all persons in the room that a spill has occurred but use caution that no individual who is contaminated will leave the area.

l

2. Provent the spread of the contamination by covering the spill area with absorbent paper and secure the area.

3. Confine the movement of potentially contaminated personnel to an area,in the same room, where they can be monitored and decontaminated.' Be sure that they don't spread the contamination. Survey these people '

and if not contaminated, have them leave the area.

4. If practical, without spreading the contamination, shield the spill but don't show the spread of contamination orincrease your exposure.

6. Close the room and lock or otherwee secure the area to prevent entry and poet a notice on the door indicating that entry is prohibited.

6. Notify the Radiation Safety Offloor (1480).

7. Ponow the direction of the RSo for decontamination of the area, completion of required documentation and evaluationof theincident.

(

Personnel Decontamination Suggestions (First Steps):

a) Remove contaminated clothing and store it for evaluation and decay. b) Flush the sidn with toped water, wash wtth mild soap and dry with absorbent paper. Repeat this step as required as long as at least 15% of the counts are removed with each washing. Avoid contamination from the wash water and use as little water as practical. l c) Radcactive materialin the eyes should be flushed with water or eye wash and an eye cup. ec.wom an% =. son a r a ,.coene aeon woemes.= w.,an-im __The difference between a major and minor spill for the radionuclides i for which application is being made is considered by the applicant to l be major if it is more than 50 mci of 99mTc, 25 mci of 201T1 and the j sealed sources, being solid material, can not spill. If the sealed t l souces could spill, more than the amount being requested would have l to be spilled. to be _a major spill.

APPUCATION FOR MATEMAL UCENSE i l RADI0 ACTIVE SPILL DOCUMENTATION l The following document, " Radioactive Spill Report", will be completed for all radioactive spills, both major and minor. This report will be used as an ' operational document for evaluation and documentation of all such incidents. In addition, each incident will also have a " Radio-active Spill Contamination Survey" report completed for each such in-cident. RADIOACTIVE SPILL REPORT (Compiew For An Reaceetive sene)

1. INCfDENT Spilt: Date Time Location Redenuchos: lootope Porm Est. Actwtry Personin Corarolofincesent:

11. SPILL AREA Note: Show the spill eres and entent of the spill on the crewing.

Ill. EVENT A. PersonnelPresent* Personnel Contaminsten Results" ineiuoe pet ents and other "non$ersonne!"

- Use the tack of the ehest to inchcese decontaminsten, morwooring. beonavey or other actions talen B. Desenpteon ofincklent C. Evaluate the magneues of heaerea aamad with the event D. Descrbe all reporting and reisted actione telen E. Deecribe follow up actens seien to prevent recurrence Report compiowd by Date e Coprve set NC&yusms. k.3Dn presemy. emmm. CO 90302 keene@ces 140H260eed on 20 m 30>44444

P APPUCATMN FOR MATERIAL UCENSE Radioactive Spill Documentation-Continued The following' report, " Radioactive Spill Contamination Survey", will be used to det' ermine the location, extent and decontamination of radioact-ive spills. This document will be used in addition to the " Radioactive i Spill Report" of the prior page in this application. RADIOACTIVE SPILL CONTAMINATION SURVEY (See the Re60ectrve Spill Report" of the incklont)

1. INCIDENT Spill: Date Teme Locaten i

Radeonuctede; lectope Form Est. Actrvtty Personin Controlofincident. ll. SPILL AREA i Note: Show the opW atos and extent of the spill on thee e awing. Ill. SUPhmY A. Ext osure instument Probe l K Sdpe ine'rument PHAAE Kev to Kev tacehon inne! Decontammefen mR/hr mRihr opm/100 cms Commons IV. ADDITIONAL CONRMINArlON N0rES (Personrel, Cloths, Equqpment. Etc.) Desortpoon Coniaminata Depoonen ecw ice..cw e mm e% e.,=,.conoxe on -*ose.-t rn. -no Note: The survey will be done with the GM survey detector system i.

APPUCATM)N FOR MATERIAL UCENSE Attaehment N. PROCEDURE FOR ORDERING RADI0 ACTIVE MATERI ALS We will follow the following procedure in ordering radioactive materials

1) The RSO or a designee must authorize each order for radioactive mat-erials to. ensure that each material ordered is authorized under the license and the amount does not exceed the possession limits under j

that license.

2) A record of all orders will be maintained which shows the isotope, activity, form and supplier of the radioactive material (see the i

" Radioactive Material Package Order and Receipt Record")

3) Radioactive materials will only be received during normal working hours and the materials will be delivered directly to the nuclear medical area and placed on the table, as indicated in the floor plan, by the nuclear medical technologist or RSO.

If the technologist or RSO are not present when the material is de-livered, the reception staff will follow the procedure which is listed below and it, the procedure, will also be posted in both the reception office and in the nuclear medical room.

4) The technologist or RSO will check the package to determine that the material is the material which was ordered.

5) The technologist or RSO will then follow the Procedure For Safely Opening Packages Containing Radioactive Material.

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APPUCATION POR MATERIAL UCENSE. PROCEDURE FOR SAFELY OPENING PACKAGES CONTAINING RADI0 ACTIVE MATERIAL The procedure. for safely opening packages we will follow is:

1) Put on gloves to prevent hand contiamination.

2) Visually inspect the package for any sign of damage such as wetness, physical damage, stains, etc and if any is noted, stop and notify the RSO.

3) Measure the exposure' rate from the package at the surface and at I meter distance from the surface.

If it is higher than expected, stop and notify the RSO. Note: The surface exposure rate of packages with the Yellow II and Yellow III labels should not exceed 200mR/hr and the surface rate of exposure for the White I labels should not exceed 0.5 mR/hr. None of the rates should exceed the posted rate on the box or the expected rate for a shippent of this type and quantity.

4) Open the package with the following steps:

a) Remove the packing slip. b) Open the outer package following the supp'11er's instructions, if such instructions are provided. c) Open the inner package and verify that the contents agree with the packing slip. d) Check the integrity of the final source container. Look for any broken seals, loss of volume, moisture or stains on the packing material. If anything is found to be other than expected, stop and notify the RSO. e) Remove the source container and place it on an absorbent pad. f) Revove the now empty shipping box to an area with low background exposure and survey with a sensitive GM survey meter. If con-taminated: (1) Treat as radioactive waste and remove for DIS and (2) Wipe the external surface of the final source container and assay the wipe, in a low background area, for any re-movable radioactivity. Use the procedure for assay of wipes as established in the " Contamination Survey Record" section III to determine the sample counts to dpm and (3) Notify the RSO. If not contaminated, remove and obliterate the radiation labels prior to discarding in the in-house trash.

5) Recheck the contents of the package to be sure it is the material that was ordered.

6) Check the activity of the sourca in the Dose Calibrator.

7) Log the paterial "in" on the correct Radioisotope Distribution Rec-ord

8) Finish the Radioactive Material. Package Order and Receipt Record as frovided on the next page of this section J

APPUCATION FOR MATERIAL UCENSE PROCEDURE FOR SAFELY OPENING PACKAGES CONTAINING RADI0 ACTIVE MATERIAL-RADI0 ACTIVE MATERIAL PACKAGE ORDER AND RECEIPT FORM These records will be maintained on the following record form shown smaller that the actual record. 5 I l l n ~ 8 11 j i i I I i I I i L 1 I i a .t 8 E l r I l x l j i a I i i

1 APPUCATION FOR MATERIAL UCENSE Attachment P, RADI0 PHARMACEUTICAL RECORDS knis ra! n do e a i$ra $ a!say and per on ekg in n re-a comp e ed n form o bel , or on o m s pp e b he adi pharmacy containing all of the same information. 1 1I e n a a s n l I I I 11 l l 1 li I;!; lli 11 110 llI ll lll lll ll lll g l1 } 1 1 i i I$ f f f I l lr ' i l l 1' I' i' l' 1" g3 g 1 i i i 1 Il j ! )i i i i I j l 1 1 1 I I I 2 l3111 } 1 i a i } l Ill l;il Ill 11;! lil 3 1]

i APPUCATOON POR MATERIAL UCENSE Attachment Q. l PROCEDURE FOR AREA SURVEYS Ambient Exposure Surveys

1) All areas where radiopharmaceuticals are used including their active storage, preparation and administration, will be subject to a sur-vey with the GM survey. detector at the end of each day in which the materials are used.

~

2) Areas that are used for only' radiopharmaceutical waste storage and in which there are no daily activities, will be subject to a survey with the GM survey detector at the end of each week.

3) The survey information will be recorded on the " Ambient Exposure Sur-

. vey" report form, see the next page, and the RSO will be notified if there are any unexpectedly high or low levels found, any level found where radionuclides should not be present or levels exceed those as established for unrestricted or restricted areas.

4) Surveys will be completed as part of the " spill" procedure.

Removable Contamination Surveys

1) All areas where radiopharmaceuticals are used including their active storage, preparation and administration, will be subject to a sur-vey with the GM survey detector at the end of each week in which the materials are used.

2) Areas that are used for only radiopharmaceutical waste storage and in which there are no daily activities, will be subject to a survey with the GM survey detector at the end of each week in which the mat-erials are used.

3) The survey information will be recorded on the " Contamination Survey Record" report form, see the 3rd page, and ghe RSO will be notified if removable contamination of 1000 dpm/100cm of 57Co, 99mTc, or of 2

201 T1 is found or if 100dpm/100cm of any other radioisotope is found or if any removable contamination is found in a unrestricted The assay will bg sufficiently sensitive to detect the pres 2 area. ence of 2000 dpm/100 cm' of 57Co. 99mTc or 201T1 and 200 cpm /100cm of any other radioisotope and this assay will use the technique of absolute counting as outlined in the " Contamination Survey Record". The survey will use " Swipes" as indicated on the 3rd page of this section.

4) Surveys will be completed as part of the " spill" procedure.

-.. ~. APPUCATMN POR MATERIAL UCENSE ] AMBIENT EXPOSURE SURVEY RECORD FORM The form used for this survey is found, reduced in size, below. The 1 floor plan of the f acility will be reproduced on the form and the locat-l ions of the measurements indicateds by numbers, on the floor plan. AMBIENT EXPOSURE SURVEY ' (Survey For Source Exposure and Cornemmaton) instrument: Probe Does of Colleproten: Recorence Check mR/hr

1. SUfWEY AREA a

1 e

11. SURVEY Identifcetion of Location and Exposure in mR/hr Operator Acton*

Date . 2 3 4 5 6 7 8 9 10 11 12 1 ( l-l l l l .g.g,Q w.m-111. EXPOSURE ACTION LEVELS (mR/hrof ambientexposure)

1. AR eroes Any unexpectedly high orlow levels

2. Aneroes Any exposure where redenuctedes should not be present 1 Unrestrictederoes 2D mR/hr or higher

4. Reetnceed eroes SD mR/hr or higher c Copynpu 100s NCeynems. Inc., son Drumousy. Soulos. CO atoot semens' Onnes 14co4244eed est rt? or acoma issa

APPUCATION FOR MATERIAL UCENM CONTAMINATION SUP,VEY RECORD FORM ik y 11 b re rd ced n he f rm ndkhe ocat-or plan the a 1 The t eo s e't w 1b u ed i fo d n th botto o he page i I I k i 1 l lji i E laa I! j I!!! f ll f i 4-{!! 4 l l } u 4 i i I. ja p lI ' I! 8 .I I I 11 "llil 1"i pi a n 3 ip}i 4 }!n p i,l I ,ll ls 1 1 j i })l! _II I R. ! ! h ! I } L jlli!! i l [ g ljjI!! l 1 ali I 38 i II {. I iII li l4@::83..g ! "n1I 81 Lc

I APPUCATION FOR MATERIAL UCENSE Attachment R. ) RADI0IS0 TOPE WASTE DISPOSAL PROCEDURE Disposal By~ Transfer

1) Spent syringes and unused sources obtained from the radiopharmacy will be returned to the radiopharmacy.

Only materials from the radiopharmacy will be returned to this supplier. Records will be made and kept of all materials returned to the radiopharmacy on the "Unidose Record-Radiopharmacy Radiopharmaceutical Unidose Record" form located in the Radiopharmaceutical Rs?brd fGttion of this ap-plication. Disposal By Decay-In-Storage (DIS) I) Short-lived material, that with a physical half-life of less than 65 days, will be disposed of by DIS.

2) Radioisotopes that are currently active, activities not used and not returned to the radiopharmacy, will be kept in the lead storage con-tainer for not less than two half-lives.

These will then be trans-fered to the DIS storage container, as described below, after the radiation label has been violated and shielding removed.

3) Syringes and capped needles will be placed in a seperate container for eventual disposal, af ter DIS, in compliance with state and local publih health regualtions.

4) Injection paraphernalia such as swabs and gause as well as tubes, and other contaminated materials will be placed directly in the DIS containers,

5) All materials placed in the DIS container will have the radiation labels violated and the shielding removed.

These materials will be placed in plastic bags, 2 ply, inside the container.. When the bag is full or every few weeks, the bag will be sealed with string or tape, identified with the date sealed, the longest lived radioisotope in the container and the initials of the person sealing the container The bag will then be contained for additional DIS, if required. No material-will be-disposed in less than 10 half-lives of the longest half-life in the container.

6) Prior to disposal, as in-house waste, the bag will be monitored with the following technique:

a) The GM survey detector will be checked for proper operation b) The bag will be removed to a low-level background area, less than 0.05 mR/hr c) All surfaces of the bag will be monitored, at the surface d) If there is no exposure above background, the bag may be dis-carded, if there is exposure, it will be returned to DIS. e) Complete records of DIS will be maintained on the " Disposal By Decay-In-Storage Record" form located on the next page. Note: Sealed sources, 57Co, 133Ba, 1370s that must be disposed by the applicant will be disposed by transfer to a supplier who has a license to receive such material and will be completely documented by the applicant prior to disposal. L

3 p APPUCATION POR MATEMAL UCENSE l l l !I 8 l' Ij, I i "1 1.i t ]!!i If Ill t fli! lil !I! lI 1 a al I ll! l {!) t ! 1 1 {11i 11 llI lIlh l: l. 1W264 g "WRCIAL RECORD COPY" glg}}

ML20033F679

Contents

Text

Subject:

Dear Applicant:

Enclosure:

Dear Dr. Rosner:

Enclosures:

= = = = = = = = = = = = = = = = =. =.

======m==== man=== an==ammamamamammanasmaan

=ame=== ame===ama==-asm an=== manes

=

c

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ML20033F679

Text

Subject:

Dear Applicant:

Enclosure:

Dear Dr. Rosner:

Enclosures:

= = = = = = = = = = = = = = = = =. =.

======m==== man=== an==ammamamamammanasmaan

=ame=== ame===ama==-asm an=== manes

=

c

Contact:

Contact:

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