ML20128E133
| ML20128E133 | |
| Person / Time | |
|---|---|
| Site: | 07001336 |
| Issue date: | 04/25/1985 |
| From: | Ruiz E PONCE DISTRICT HOSP., PONCE, PR |
| To: | |
| Shared Package | |
| ML20128E094 | List: |
| References | |
| 50578, NUDOCS 8507050264 | |
| Download: ML20128E133 (59) | |
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NRC FORM 313M U.S. NUCLE AR REGULATORY COMMISSION Approved by OMB APPLICATION FOR MATERIALS LICENSE - MEDICAL 10 CFR 35 lNSTR UCTIONS - Comparte Items 1 through 26 if this a an initialapplication or an appIkat on for renewalof a lieense. Use supplementalsheets where necessary, item 26 must be completed on allapplications and signed. Retain one copy. Submit originaland one copy of entire application ^o : Director, Office of Nuclear Materials Safety and Safeguards. U.S. Nuclear Regulatory Commission. Washington, D C.
205$5. Upon approvalof this application, the applicant willreceive a Materials License. An NRC Materials t icense is issued in accord-ance with the general requirements contained in Title 10. Code of federal Regulations. Part 30. and the Licerver is subject to Title 10 Code of federal Regulations Parts 19,20 and 35 and the Ccense feeprovision af Title 10. Code of federal Replations. Part 170. The ficanse f* 9 category should be statedin item 26 and the appropriate fee enclosed.
1.c. NAME AND MAILING ADDRESS OF APPLICANT (institution, 1.tt STREET ADDRESS (ES) AT WHICH R ADIOACTIVE MATERIAL firm, clinic, phys'cian,etc) INCLUDE ZIP CODE WILL SE USED (t/diflittent from 1.aL) INCLUDE ZIP CODE Ponce District Hospital Machue10 Road 14 Same Ponce, PR 00731 TE LEPHONE NO.: AREA CODE 18093 84 4 2080
- 2. PERSON TO CONTACT REGARDING THIS APPLICATION
- 3. THISIS AN APPLICATION FOR: (Chece appropriate item)
Evelyn CintrOn Ruiz, M.D.
[ @ [gy,","g7 TO LICENSE NO.
8' AREA CODE p09 ) 844-2080 ext'*-
c 0 RENEWAL OF LICENSE NO. N l}Q TE LEPHONE NO.:
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- 4. INDIVIDUAL USERS (Name individuals who willuse or directly '
'5. RADIATION SAFETY OFFICER (RSO) (Name ofperson designated supervise use of radioactive material. Complete Supplements A and B as radiation safety officer. If other than individualuser, complete resu-for each individual.)
me of training and experience as in Supplement A.)
Evelyn CintrOn Ruiz, M.D.
Evelyn CintrOn Ruiz, M.D.
6.a. RADIOACTIVE MATERIAL FOR. MEDICAL USE MAXIMUM MARK MAXIMUM ITEMS POSSESSION ITEMS POSSESSION ADDITIONAL ITEMS:
DESIRED LIMITS RADIOACTIVE MATERIAL DESIRED LIMITS LISTED IN:
"X" (In millicuries)
"X" (In millicuries)
IODINE-131 AS IODIDE FOR TREATMENT 10 CFR 31.11 FOR IN VITRO STUDIES
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OF HYPERTHYROIDtSM 10 CFR 35.100, SCHEDULE A. GROUP i AS NEEDED PHOSPHORUS-32 AS SOLUBLE PHOSPH ATE (OR TREATMENT OF POLYCYTHEMIA VYRA.LEUKEMI A AND BONE METASTASES 10 CFR 35.100, SCHEDULE A GROUP 11 AS NEEDED PHOSPHORUS-32 AS COLLOIDAL CHROMIC PHOSPHATE FOR INTRACAVITARY TREAT-10 CF R 35.100, SCHEDU LE A, GR OUP 111 MENT OF MALIGN ANT EFFUSIONS.
GOLD-198 AS COLLOID FOR INTRA-CAVITARY TREATMENT OF MALIGNANT 10 CFR 35.100, SCHEDULE A, GROUP IV AS NEEDE D E F FUSIONS.
IODINE 131 AS lODIDE FOR TREATMENT 10 CFR 35.100, SCHEDULE A, GROUP V AS NEEDED OF THYROID CARCINOMA XENON-133 AS GAS OR GAS IN SALINE FOR BLOOD FLOW STUDIES AND PULMONARY 10 CFR 35.100, SCHEDULE A, GROUP VI FUNCTION STUDIES.
6.b. RADIOACTIVE MATERIAL FOR USES NOT LISTED IN ITEM 6.a. (Sealedsourcesup tosmCiusedfor calibration and reference standards are authorized under Section 35.14(d),10 CFR Part 35, and NEED NO T BE LISTEDJ CHEMICAL MAXIMUM NUMBER ELEMENT AND MASS NUMBER PHY IC L ORM OF M
sealed 150 mgs Implantation in humans Plutonium 238 source in 1 source (Cardiac pacemaker)
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cardiac Of 150 mgs
-already implanted p
pacemaker Pu 238 in a patient-(2.5 ci in i
1972)
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INFORMATION REQUIRED FOR ITEMS 7 THROUGH 23 For items 7 through 23, check the appropriate box (es) and submit a detailed description of all the requested information. Begin each item on a separate sheet. Identify the item number and the date of the tpplication in the lower right corner of each page. If you indicate that an appendix to the medical licensing guide will be followed, do not submit the pages, but specify the revision number and date of the referenced guide: Regulatory Guide 10.8
,, R ev.
Date:
- 15. GENERAL RULES FOR THE SAFE USE OF
- 7. MEDICAL ISOTOPES COMMITTEE RADIOACTIVE MATERIAL (Check Onel Appendix G Rules Followed;or X.
Names and Specialties Attached;and X
y' Duties as in Appendix B;or y
Equivalent Rules Attached (Check One)
Equivalent Duties Attached
- 16. EMERGENCY PROCEDURES (Check One)
- 8. TRAINING AND EXPERIENCE Board of N.Med.
X Appendix H Procedures Followed;or Supplements A & B Attached for Each frdividual User; EquivalentProcedures Attached and Supplement A Attached for RSO.
- 17. AREA SURVEY PROCEDURES (Check One)
- 9. INSTRUMENTATION (Check One)
[ Appendix 1 Procedures Followed;or Appendix C Form Attached;or X
Equivalent Procedures Attached List by Name and Model Number
- 18. WASTE DISPOSAL (Check One) y
- 10. Call 8 RATION OF INSTRUMENTS Appendix J Form Attached;or Appendix D Procedures Followed for Survey X
Instruments; or X.
Equivalent Information Attached
^
^
Equivalent Procedures Attached;and 19' (Check One)
No Appendix D Procedures Followed for Dose X
Calibrator;or Appendix K Procedures Followed;or Equivalent Procedures Attached Equivalent Procedures Attached
- 11. FACILITIES AND EQUIPMENT
- 20. THERAPEUTIC USE OF SEALED SOURCES No y
Description and Diagram Attached Detailed information Attached;and
- 12. PERSONNEL TRAINING PROGRAM Appendix L Procedures Followed;or (Check One)
Description of Training Attached Equivalent Procedures Attached y
PROCEDURES FOR ORDERING AND RECEIVING PROCEDURES AND PRECAUTIONS FOR USE OF
- RADIOACTIVE MATERIAL
- 21. RADIOACTIVE GASES (e.g., Xenon - 133)
No y
Detailed Information Attached Appendix E PROCEDURES AND PRECAUTIONS FOR USE OF PROCEDURES FOR SAFELY OPENING PACKAGES
- 22. RADIO ACTIVE MATERIAL IN ANIMALS No 14.
CONTAINING RADIOACTIVE MATERIALS (Check One)
Detailed information Attsched Appendix F Procedures Followed;or X
23 RADIOACTIVE MATERIAL SPECIFIED IN ITEM 6.b emaW Equivalent Procedures Attached Detailed Information Attached.
fCC FORM 313M (241)
Page 2 t
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- 24. PERSONNELMONITORING DEVICES SUPPLIE R (Deck app riate box)
EXCHANGE FREQUENCY FILM
e*o"oy TLo X Siemens GammaSOniCS, Inc.
Monthly OTHE R (Specify)
FILM
- b. FINGER TL X
Same Monthly OTH E R (Speerfy)
FILM
- c. WRIST TLD OTHER (Specify]
- d. OTHER (Specify)
I
- 25. FOR PRIVATE PRACTICE APPLICANTS ONLY
- a. HOSPITAL AGREEING TO ACCEPT PATIENTS CONTAINING RADIOACTIVE MATERI AL
. N AME OF HOSPITAL 11 ATTACH A COPY OF THE AGREEMENT LETTER SIGNED BY THE HOSPITAL ADMINISTRATOR.
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- c. WHEN REQUESTING THERAPY PROCEDURES.
ATTACH A COPY OF RADIATION SAFETY PRECAU-CITY STATE ZIP CODE TlONS TO BE TAKEN AND LIST AVAILABLE RADIATION DETECTION INSTRUMENTS.
- 26. CERTIFICATE (This item must be completed by applicant)
The appiscant and any of ficial executing this certificate on behalf of the apphcant named in item la certify that this application is prepared in conformity with Title 10. Code of Federal Regulations. Parts 30 and 35,and that allinformation contained herein, including any supplements attached hereto,is true cid correct to the best of our knowledge and belief.
Please, send written request of fee, tO b.
PL ANT CE97 FYi " GF FICI Al lSignature)
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- a. LICENSE FEE REQUIRED
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(See Section 170.
10 CFR request payment frOm losp. A ministration (1) NhME (Type of Printi r
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nFrico.
Eu e lvH
/N YM'V 0.'z (1) LICENSE FEE CATEGORY:
(2) TIT {E Nuc4eoi2 Me.cluc/nel Dysician
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- c. DATE m uCENSE FEE ENCLOSED: $
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NRC FORM 313M (9411)
Page 3
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N1C FORM 313M SUPPLEMENT A U.S. NUCLEAR REGULATORY COMMISSION TRAINING AND EXPERIENCE AUTHORIZED USER OR RADIATION SAFETY OFFICER
- 1. NAME OF AUTHORIZED USER OR RADIATION SAFETY OFFICER
- 2. STATE OR TERRITORY IN WHICH LICENSED TO Evelyn Cintron Ruiz, M.D.
PRACriCE MEDICINE Puerto RicO
- 3. CERTIFICATION SPECIALTY BOARD CATEGORY MONTH AND YEAR CERTIFIED A
B C
Copy of Board certificate enclosed.
- 4. TRAINING RECElVED IN BASIC RADIOlSOTOPE HANDLING TECHNIQUES TYPE AND LENGTH OF TRAINING LECTURE /
SUPERVISED FIELD OF TRAINING LOCATION AND DATE(S) OF TRAINING LABORATORY LABORATORY A
B COURSES EXPERIENCE (Hours)
(Hours)
C D
- a. RADIATION PHYSICS AND INSTRUMENTATION b RADIATION PROTECTION
- c. MATHEMATICS PERTAINING TO THE USE AND MEASUREMENT OF RADIOACTIVITY
- d. RADIATION BIOLOGY
- e. RADIOPHARMACEUTICAL CH EMISTRY -
- 5. EXPER1ENCE WITH RADl ATION. (Actual use of Radioisotopes or Equivalent Experience)
ISOTOPE MAXIMUM AMOUNT WHERE EXPERIENCE WAS GAINED DUR ATION OF EXPERIENCE TYPE OF USE NRC FORM 313M Supplement A G8u Page 5
m a
. RECEPTOR STATEMENT (Continueur-c
- 2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICIAN (Continued)
NUMBER OF CASES INVOLVING COMMENTS ISGTOPE CONDITIONS DIAGNOSED OR TREATED PERSONAL (Aaditionat in formation or comments may be PARTICIPATSON submittedin civplicate on separate sheets)
A B
C D
P-32 TREATMENT OF POLYCYTHEMIA VERA, (Soluble)
LEUKEMIA, AND BONE METASTASES INTR ACAVITARY TRE ATMENT dall TRE ATMENT OF THYROID CARCINOMA 1131 TREATMENT OF HYPERTHYROIDISM Au-108 (NTRACAVITARY TRE ATMENT C&GO INTERSTITI AL TRE ATMENT or C&137 INTRACAVITARY TREATMENT l-125 INTERSTITI AL TRE ATMENT or t r-192 C&60 or TE LETHE RAPY TRE ATMENT Cs-137 Sr-90 TRE ATMENT OF EYE DISEASE R ADIOPHARMACEUTICAL PREPARATlON fc 99 GENE R ATOR lI GENERATOR yj Tc-99m REAGENT KITS Other
- 3. DATES AND TOTAL NUMBER OF HOURS RECEIVED IN CLINICAL RADIOlSOTOPE TRAINING
- 4. THE TRAINING AND EXPERIENCE INDICATED ABOVE
- 5. PRECEPTOR'S SIGN ATURE WAS OBTAINED UNDER THE SUPERVISION OF:
a NAME OF SUPE RVISOR tA NAME OF INSTITUTION
- 7. PRECEPTOR'S NAME (Please type orprint)
- c. MAlltNG ADDRESS 4 CITY
- 8. DATE
- 5. MATEHI ALS LICENSE NUMBER (S)
NRC FORM 313M SUPPLEMENT 8 (941)
GPO 890 99 3 Page 7
NRC FORM 313M SUPPLEMENT B U. S. NUCLE AR REGULATORY COMMISSION (X1)
PRECEPTOR STATEMENT Supplement B must be completed by the applicantphysician's preceptor. If more than one preceptor is necessary to document experience, obtain a separate statemen t frorn each
- 1. APPLICANT PHYSICI AN'S NAME AND ADDRESS KEY TO COLUMN C PE RSON AL PARTICIPATION SHOULD CONSIST OF:
FtiLL N AME 14upervised examination of patients to determine the suitability for radioisotope diagnosis and/or treatment and recommendation f or prescribed dosage.
STREET ADDRESS 240llaboration in dose calibration and actual administration of dose to the patient including calculation of the radiation dose, related measurements and plotting of data.
Cl TY l STATE l ZIP CODE 3-Adequate period of training to enable physician to manage radioactive patients and follow patients through diagnosis and/or course of t reat ment.
- 2. CLINICAL TRAINING AND EXPERIENCE OF ABOVE NAMED PHYSICI AN NUMBER OF CASES INVOLVING COMMENTS ISOTOPE CONDITIONS CI AGNOSED OR TREATED PE RSON AL (Additiona/ in formation or comments may PARTIClPATION be submittedin duplicate on separate sheets.)
A B
C D
DI AGNOSIS OF THYROID FUNCTION DETERMIN ATION OF BLOOD AND DLOOD PLASM A VOLUME I.131 LIVER FUNCilON STUDIES g,
1-125 FAT ABSORPllON STUOlES KIDNEY FUNCTION STUDIES IN VITRO STUDIES OTHER l-125 DETECTION OF THROMBOSIS l-131 THYROID IM AGING P-32 EYE TUMOR LOCALIZATION Se-75 PANCRE AS IMAGING Yb-169 CISTE RNOGR APHY BLOOD FLOW STUDIES AND A-133 PULMON ARY FUNCTION STUDIES OTHER BRAIN IM AGING CARDI AC lM AGING TH YROI D IM AGING SALIVARY GLAND IMAGING Tc-99m 8LOOD POOL IMAGING PLACENTA LOCAllZATION LIVER AND SPLEEN IMAGING LUNG IM AGING BONE IM AGING OTHER NRC FORM 313M SUPPLEMENT B Page 6 (9 81),
L 1
6 (b) Plutonium-238 source in a nuclear pacemaker'already
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implanted in nov. 4, 1975 to patient Gregorio Cruz l-Rodriguez case.no. 3-40-91 with a clinical diagnosis f
of Sick Sinus Syndrome with bradycardia.
The patient is followed at the cardiology outpatient clinic and at the Nuclear Medicine Section every 6 to 12 months.
He is evaluated as to presence of symptons suggestive of pacemaker malfunction.
A physical exam is performed to evaluate cardiovascular status and the site of inser-tion a long lead II or complete EKG is performed to assess pacemaker capture.
When pacemakcr malfunction is suspect'ed the patient is hospitalized for complete evaluation. (He was hospita-lized in Feb 1980 because of dizzy spells.
Pacamaker was functioning well).
If malfunction is established sur6ical exploration is t
performed to asess if failure of electrodes or failure of pacemaker generator. (These had been performed with 2 previously" implanted nuclear pacemakers in other 2 patients.
Patient.is also examined at the Nuclear Medicine Department for activity (mr/hr) present at the site of pacemaker and at opposite. site.
Records are kept of all examinations.
Patient carries his identification card with him at all times.
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RADIATION SAFETY COMMITTEE Membership Requirements accordin6 to Nuclear Regulatory Commission Enforcement Policy 47, FR 9987 (May 9, 1982);
47, FR 401, 150 (Sept 13, 1982), and NRC Title 10, 35.11 (b).
- 1. Representative of the institution management:
Hospital administrator (or medical director) name Nilda R. Cartacho, FACIIA specialty Unspitn1 Adminietv,tign Position Administrator Ponce Regional llospital
- 2. Representative of the nursin6 staff:
Hospital nurse supervisor Ju nita Marietti, R.N.
name specialty registered nurse Position Hospital nurse supervisor
- 3. Authorized user in licence (Nuclear medicine physician) name Evelyn Cintron, M.D.
Position Director-Nuclear Medicine
- 4. Radiation physicist name Mr. Daniel Torres specialty 11 diation Physics Position Consultant
e Radiation Safety Committee NCR Chapter I 35.11 specific licence for human use.
(b) appoint a radiation safety committee to 1-over see the use of licence material u
throu6 put the institution.
h 2-review institution radiation safety program.
Membership of the committee (at Icast to include) 1-authorized user for each type of use permitted by the licence.
2-a representative of the nursing staff 3-a representctive of the institutions management 4-a Radiation safety officer Committee:
- 1. Name and specialty of members
- 2. Frecuency of meetings (quarterly)
- 3. Responsibility and Dutiec (as described in appendix B,or,, submit a description)
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O ISOTOPE COMMITTEE FUNCTIONS AND RESPONSIBILITIES GOVERNING THE USE OF RADI0 PHARMACEUTICALS AT THE PONCE DISTRICT HOSPITAL Res ponsibil.itie s :
- 1. Approve or disapprove experimental or non-routine use of radioisotopes before licence is applied for such use, as well as proposals for dia6nostic and therapeutic use of radionuclides.
- 2. Prescribe conditions required for a proposed use of radio-pharmaceuticals such as physical examinations, training, experience of others, special equipment that is necessary.
- 3. Receive and review radiation safety records and reports.
Review occupational radiation exposure quarterly and ensure that radiation occupational exposure is as low as reasonably acceptable.
- 4. Make recommendations to correct radiation safety infractions; formulate training program for safe use of radioisotopes.
- 5. Maintain record of actions taken by the committee.
- 6. Inform of any changes in the committee membership.
- 7. The Services of the Consultant (radiation physicist) will be used for inservice education, and refresher training to all personnel (trained and ancillary) annually; and for yearly instrument calibration.
- 8. Review the entire radiation safety program annually to determine that all activities are conducted safety in accordance with NRC licence.
- 9. The Committee should meet quarterly.
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Administrative Procedures:
- 1. Make revision of radioisotope program as needed.
- 2. Review and keep up to date a nuclear medicine procedure manual of all diagnostic studies done.
- 3. Give instructions and laboratory rules to personnel using radioisotopes at the institution.
- 4. Give instructions regarding radiation safety to hospital personnel and patients durin6 radioisotope therapy.
- 5. Maintain written records of receipts, transfers, and dispo-sal of radioisotope; keep inventory of total quantity of material available at the institution; keep record of re6uldr radiation surveys, calibrat. ions and maintenance of equipment. Keep records of occupational radiation exposure.
- 6. Keep record of meetings, decisions, and recommendations.
- 7. Prepare a radiation safety program.
- 8. Dr. Evelyn Cintron will be responsible for day to day i
radiation safety program.
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APPENDIX B
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ME DICAL ISOTOPES COMMITTEE' Responsibihty keeping personnei) are properly instructed as required by @ 19.12 of 10 CFR Part 19.
The committee is responsible for ;
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Review and approve all requests for use of radioactive 1.
Ensuring that all indisiduals who work with or in the material within the institution.
vicinity of radioactive snaterial have sufficient training and experience to enable them to perform their duties 5.
Prescribe special conditions that wiU be required dur-safely and in accordance with NRC regulations and ing a proposed use of radioactive material such as the conditions of the license, requirements for bioassays, physical examinations of users, and s;.ecial monitoring procedures.
2.
Ensuring that all use of radioactive material is con-ducted in a safe mar,ner and in accordance with NRC 6.
Review the entire radiation safety propam at least regulations and the conditions of the li:ense.
annually to determine that aU activities art being corr ducted safely and in accordance with NRC regulations Duties and the conditions of the license. The review shall include an examination of au records, reports from the The committee shau-radiation safety officer, results of NRC inspection, written safety procedures, and the adequacy of thr 1.
Be famihar with all pertinent NRC regulations, the institution's tr.anagement control system.
terms of the license,and inforrr.ation submitted in sup-port of the request for the ticense and its amendments.
7.
Recorrurierd remedia! action to correct any deficiencies identified in the radiation safety program.
2.
Review the training and emperier.ce of aU indisiduals who use radiciactise material (including physicians, 6.
Maintain w itten records of all committee meetingi.
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technolor.ists, physicists, and pharmacists) and deter-actions, recommendations, and decisions.
N mine that their qualifications are sufficient to enable them to perform their duties safely and in accordance 9.
Ensure that the byproduct materiallicense is amended, with NRC regulations and the conditions of the license, when necessary, prior to any changes in facilities, equipment, policies, procedures, and personnel, as 3.
Establish a propam to ensure that aU individuals whose specified in the license.
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duties may require them to work in the vicinity of radioactive material (e g., nursing. security,and house-Meeting Frequency The medical isotopes committee shall meet as often as necea-A n,te is en rected in sees thai would chanse the name.compc*3-rion. and r nctions of shia committee.
ealendar quarter.
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'+t RADIATION DETECTION INSTRUMENTS NAME MODEL
- 1. Nuclear Chicago Model N. 6372 Median Dose Calibrator
- 2. Deluxe isotope Calibrator II Model 34056 Victoreen i uci to 2 curies
- 3. Victoreen Cutie pie Model 740 D Survey meter.
range 0-2,500 mr/hr.
- 4. Portable survey meter Technical Associates Contamination meter Model TBM-3 Range 0-15 mr/hr 0-50,000 CPM
- 5. Nuclear Chicago Model DS-202 v Scintillation 2" Scintillation Well detector with 8166 Decade counter scaler with dual timer
- 6. Nuclear Chicago Model 915 scintillation uptake unit detector and Decade scaler timer Model 49-25
- 7. Picker dynacamera 4/15/37 Whole Body System Dual Isotope with auto peak:
- 8. MDS Computer system 10,000 Basic A2 Mobile system
- 9. Automatic Processor-Kodak M6 aW k
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APPENDIX.C INSTRUMENTATION 1
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1.
Survey meters a.
Manufacturer's name: pon'rAnr.v HRmnn mRcimTrar. acSOCIATES Manufacturer's model number: d TBM-3 Number of instruments available:
1 Minimum range:
0 mr/hr to 0.17 mr/hr Maximum range:
0 mr/hr to 17.0 mr/hr b.
Manufacturer's name: VICTOREEN CUTIE PIE Manufacturer's model number:
MODEL 740-D Number of instruments available:
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ranges:
0-2,500 MR/HR Minimum range 0
mr/hr to 25 mr/hr Maximum range 0
mr/hr to 2,500 mr/hr
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Dose calibrator Manufacturer's name:
[I[/op.ee+
. Manufacturer's model number:
396C6 e/uxe So Yor o I^ / E Number of instruments av'ailable:
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- 3.
Diagnostic instruments Manufacturer's Type of Instrument Name Model No.
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- 4. -
Other (m'.
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CALIBRATION OF EQUIPMENT Method: According'to Regulatory Guide 10.8 Preparation of Medical Programs, Appendix D, Sections 1 and 2, calibration of instruments.
A. Uptake and measurement equipment:
Equipment will be checked daily with Cesium 137 standard sources containing 0.1 uci and 1.21 uci.
Counts per minute per microcurie of iodine tracer will be determined for thyroid uptake unit when used in uptake tests.
B. Frecuency of calibration of dose calibrator
- 1. Instrument constancy-daily.
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- 2. Instrument accuracy-at installation and annually.
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- 3. Instrument Linearrity, at installation and quarterly.
C. Standards used in calibration
- 1. constancy-Co 57 Standard of at least 1 mei Cs 137 200 uci source
- 2. accuracy-Os 137 200 uci standard Co 57 5 mei Standard NES-206 Vial E (by New England Nuclear)
- 3. Linearity-first elution of new Tc 6enerator 4
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CALIBRATION OF SURVEY METERS ACCORDING TO APPENDIX D, SECTION 1:
CALIBRATION OF INSTRUMENTS, REGULATORY GUIDE 10.8: GUIDE FOR PREPARATION OF MEDICAL PROGRAM
- 3. C. Survey instruments will be calioraten oy a consultant:
Mr. Daniel Torres, Radiation physicist and Safety Officer at the Medical Center in Mayaguez, Puerto Rico.
Lic no. 52-18306.
Also refer to Licence no.52-ll832-01 Ponce Oncolo6ic Hospital.
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- 4. Calibration sources:
Co-60 10 01 (Calibrated by N.B.S.)
Ra-226 10 mci (Calibrated by N.B.S.)
Cs-137 100 mci (Calibraten by N.B.S.)
Cs-137 200 uci supplied by New England Nuclear (calibrated by direct comparison with NBS standara) NES-206
- 5. The calibration procedures in appendix D Section 1 will be i
used.
Sources of Cs-137, Ra-226 anc C0-60 are appropriate for the performance of calibration.
The activity of the standard should be sufficient to calibrate the survey meters on all I
ranges, or at least up to 1R/ hour.
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C APPENDIX D Section 1 METHODS FG CALIBRATION OF SURVEY METERS, INCLUDING PROCEDURES, STANDARDS AND FREQUENCY A.
Calibration of survey meters shall be performed with radionuclide sources.
1.
The sources shall be approximate point sources.
2.
The source activities shall be traceable within 5% accuracy to the U.S. National Bureau of Standards (NBS) calibrations.
3.
The frequency shall be at least annually.
4.
Each scale of the instrument shall be calibrated at approximately 1/3'and 2/3 of full scale.
5.
The exposure rate measured by the instrument shall differ from the true exposure rate by less than 10% of full scale (read j
appropriate section of the instrument manual to determine how to make necessary adjustments to bring instrument into calibra-tion).
Readings within + 20% will be considered acceptable if a calibration chart or graph is prepared and attached to the
,nf instrument.
NOTE:
Sources of Cs-137, Ra-226, or Co-60 are appropriate for the performance of calibration.
The activity of the calibration standard should be sufficient to calibrate the survey meters on all ranges, or at least up to 1 R/ hour.
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B.
A reference check source of long half-life, e.g. Cs-137 or Ra D and E, shall also be read at the time of the above calibration.
The readings shall be taken with the check source placed in specific geometry relative to the detector. A reading of this reference 1
check source should be taken:
1.
Before each use.
2.
After each maintenance and/or battery change.
3.
At least quarterly.
If any reading with the same geometry is not within +20% of the reading measured immediately after calibration.
The instrument should be recalibrated (see Step A).
C.
The instrument must be calibrated at lower energies if its response is energy dependent and it is to be used to measure in the I-125, Xe-133, or Tc-99m energy ranges.
l This calibrgtion may be done either:
1.
As in A. above with calibrated standards of radionuclides at or near the desired energies, or 2.
As a relative intercomparison with an energy independent instrument and uncalibrated radionuclides.
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D.
Records of the above, A, B-2, B-3, and C must be maintained.
E.
Use of Inverse Square Law and P.adioactive Decay Law 1.
A calibrated source will have a calibration certificate giving its output at a given distance measured on a specified date by the manufacturer or NBS.
a.-
The Inverse Square Law may be used with any point source to calculate the exposure rate at other distance, b.
The Radioactive Decay Law may be used to calculate the output at other times after the specified date.
1 2.
INVERSE SQUARE LAW S
(R)
(R) j 2
- ..p
......p ExposurepateatP2 2, (Pj)
R XRj (p)2 where (a) S is the point source (b) R) and R2 are in the same units (mR/h or R/h)
(c) Pj and P2 are in the same units (cm, meter, feet etc.)
1 (q
t t
L
4
(^.
3.
RADIOACTIVE DECAY LAW:
Exposure rate t units of time after specified calibration date:
t = R, x e -[0 693 x t) where (a) R and Rt are in the R
o 1/2 units (mR/h or R/h):
(b) R, is exposure rate on specified calibration j
date m.
(c) R is exposure rate t t
unit of time later (d)T and t are in the l/2 same units (years, months, days,etc.)
(e)T is radionuclide l/2 half-life (d) t is number of units of time elapsed between calibration and present time 4.
Example: Source output is given by calibration certificate as 100 mR/h at i foot on 10 March 1975.
Radionuclide half-life is 5.27 years.
Question: Nhatistheoutputat3feeton10 March 1977 (2.0 years)?
b
0.(
a.
Output at 1 foot, 2.0 years after calibration date:
R = 100 mR/hr x e -(0.693
= 100 x 0.77 = 77 mR/hr 53 at 1 foot on 10 March 1977.
- -c ;;,...
b.
Output at 3 feet, 2.0 years after calibration date:
x77mR/hr=hx77=8.6mR/hrat f0 R feet =
3 f
3 feet, 2.0 years after calibration.
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CALIBRATION OF SURVEY INSTRUMENTS
' Check appropriate items 1.
Survey instruments will be calibrated at least annually and following repair.
2.
Calibration will be performed at two points on each scale.
The two points will be approximately 1/3 and 2/3 of full scale. A survey instrument may be considered properly calibrated when the instrument readings are within + 10%
of the calculated or known values for each point checked.
Readings within + 20% are considered acceptable if a calibration chart or graph is prepared and attached to the ina
. ment.
3.
Survey instruments will be calibrated a.
By the manufacturer b.
At the licensee's facility (i) Calibration source Manufacturer's name Model no.
Activity in millicuries Accuracy Traceability to primary standard (ii) The calibration procedures in Appendix D,Section I will be used.
or (iii) The step-by-step procedures, including radiation safety procedures are attached, c.
By a consultant or outside firm (i) Name lii) Location (iii) Procedures and sources have been approved by NRC and are on file in License No.
(.'
are attached so
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CALIERATION OF-DOSE CALIBRATOR
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I Sources Used for Linearity' Test:
'A
- +
s Check as appropriate M;[~
first ilution frm new Mo-99/Tc-99m generator 3 4 p.
, or
'y
,other* (spec,1fy}-
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B.
Scitrc,is;ijs,ei for Instrument'. Accuracy and Constancy Tests:
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Radiondclide Activity Accuracy N
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+
s
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133-Ba j
s-p 2
s.137.Cs v
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A w3other
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.s? 'The piocedures. 'desc?ibed in Appendix D Section 2 will be 2 s tw
?!!K
,C.
j s,
usedsfor calit, ratio,n, of the dose calibrator.
- 9.,
T J,
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- 7j Equivalent procedu.e are attached.
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- Must bd equivalent to the. highest activity used.
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APPENDIX D Section 2 METHODS FOR CALIBRATION OF DOSE CALIBRATOR
?
All radiopharmaceuticals must be assayed for activity to an accuracy of L
10%.
The most common instrument for accomplishing this is an ionization type dose calibrator. The instrument must be checked for accurate operation at the time of installation and periodically thereafter.
r A.
Test for the following:
1.
Instrument linearity (at installation and quarterly) 2.
Geometrical variation (at installation) q 3.
Instrument accuracy (at installation and annually).
B.
After repair or adjustment of the dose calibrator, repeat all of the appropriate tests listed above (dependent upon the nature of the repairs).
C.
Daily or before each use of the the instrument:
l.
Measure and record the activity of at least one reference source (e.g.,1-2 mci of Co-57). This check should be repeated during the day whenever sample readings are not within 10% of the anticipated assay.
Variation greater than 5% in this test will indicate the need for instrument repair, adjustment or
- {c..
recalibration.
=
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- 2.
Measure and record the apparent activity of a"long-lived standard radionuclide such as Cs-137 or Radium-226 at all of the commonly used radionclide settings (when the unit was first calibrated against NBS-traceable standards).
Choose a source
-with activity in the ~100 pci. range _.
A -.,
,.. 4.
. 3.;
,.4,
D.
Inspect the instrument on a quarterly basis to ascertain that the measurement chamber liner is in place and that instrument zero is properly set (see manufactuer's instructions).
E.
Test of Instrument Linearity The linearity of a dose calibrator should be ascertained over the entire range of activities employed. This test will utilize a vial of Tc-99m whose activity is equivalent to the maximum anticipated activity to be assayed (e.g., the first elution from a new generator).
1.
Assay the Tc-99m vial in the dose calibrator and subtract background level to obtain net activity in millicuries.
,e ;'J _qp:4 y sg23 fRepeatfstepfl{.at. time,.intervalssof. 6',y24);304(aridi48 Aoursl %
after the initial ~ assay.
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3.
Using the 30 hour3.472222e-4 days <br />0.00833 hours <br />4.960317e-5 weeks <br />1.1415e-5 months <br /> activity measurement as a starting point calculate the predicted activities at 0, 6, 24, and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />
.using the following table:
Assay Time (hrs.)
Correction Factor 0
32 6
16 24 2
30 1
48 0.125 Example:
if the net activity measured at 30 hrs. was 15.625 millicuries, then the predicted activity for 6 and 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> would be 15.625 mci x 16 = 250 mci and 15.625 mci x 0.125 - 1.95 mC1 respectively.
4.
Plot the measured net activity for each time interval versus the predicted activity on log-log graph paper.
e 5.
The activities plotted should be within + 5% of the predi.cted curve if the instrument is linear and functioning properly.
Errors greater than + 5% indicate the need for repair or adjustment of the instrument.
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6.
If instrument linearity cannot be corrected, it will be necessary in routine assays to either assay an aliquot of the eluate that can be accurately measured, or to use the graph constructed in step 4 to relate measured activities to true activities.
G.
Test for Geometrical Variation There may be significant geometrical variation in activity measured as a function of sample volume or corfiguration, depending on the volume and size of the ionization chamber used in the dose calibrator.
The extent of geometrical variation should be ascertained for
\\
commonly used radionuclides and appropriate correction factors computed if variations are significant, i.e., greater than + 2%
(even though correction factors may be provided by the manufacturer, the accuracy of these should be checked).
To measure variation with volume of liquid, a 30 cc vial containing 2 mci of Co-57 or other appropriate radionuclide in a volume of 1 m1 will be used.
1.
Assay vial at the appropriate instrument setting and subtract background level to obtain net activity.
k'
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aw
--r-,
-, +,-
n y
. 2.
Increase the volume of liquid in the vial in steps to 2, 4, 8, 10, 20 and 25 m1 by adding the appropriate amount of water or saline. After each addition, gently shake vial to mix contents and assay as in step 1.
3.
Select one volume as a standard (such as the volume of reference standard used in performing the test for instrument accuracy) and calculate the ratio of measured activities for each volume.
to the reference volume activity.
This represents the volume i
correction factor.
Example:
if activities of 2.04, 2.02, and 2.00 mC are measured for 4, 8, and 10 mi volumes and 10 ml is the reference volume selected, then 4 ml Volume CF = %
= 0.98 4.
Plot the correction factors against the volume on linear graph i
y; paper. Use this graph to select the proper volume correction factors for routine assay of that radionuclide.
L c1 e
,=
5.
The true activity of a sample is calculated as fo11cws:
True Activity = Measured Activity x CF Where the CF used is for the same volume and geometrical configuration as the sample measured.
- ex 6.
Similarly, the same activity of Co-57 in a syringe may be compared with that of 10 mi in a 30 cc vial and a correction factor calculated.
7.
It should be noted that differences of 200% in dose calibrator readings between glass and plastic syringes have been observed for lower energy radionuclides such as I-125.
Hence adequate correction factors must be established for this type of syringe.
An alternate to providing syringe calibration factors is to simply assay the stock vial before and after filling the syringe.
The activity in the syringe is then the difference in the two readings (with a volume correction if significant).
??m:
p; H.
. Test For Instrument Accuracy The accuracy of the dose calibrator should checked for several radionuclides such as Cs-137, Co-57, and Ba-133 using appropriate 1
- reference standards whose activity is traceable to NBS.
The y
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activity levels of the reference sources used should approximate those levels normally encountered, giving adequate attention to source configuration. The lower energy reference standards (Tc-99m, Xe-133. I-125) must be in vials with the same thickness of glass as the actual samples to be measured for best accuracy.
1.
Assay the reference. standard in the dose calibrator at the appropriate setting and subtract the background level to obtain the net activity.
2.
Repeat step 1 for a total of 3 determinations and average results.
3.
The average activity determined in step 2 should agree with the certified activity of the reference source within + 5%
after decay corrections.
4.
Repeat the above steps for other commonly used radionuclides for which adequate reference standards are available.
m 5.
Keep a log of these calibration checks.
6.
Calibration checks which do not agree within + 5% indicate that the instrument should be repaired or adjusted.
If this
(.!
4
- t
is not possible a calibration factor should be calculated for use during routine assays of radionuclides.
7.
At the same time the instrument is being initially calibrated with the NBS traceable standards, place a long-lived source in the calibrator, set the instrument, in turn, at the various ra'dionuclide settings used (Cs-137, I-131, Tc-99m, I-125, etc.) and record the readings. These values may later be used to check instrument calibration at each settings (after correcting for decay of the long lived source), without
- 1(
requiring more NBS traceable standards.
Keep a log of these initial and subsequent readings.
I.
Test for Instrument Constancy Two reference sources such as Cs-137 and Co-57 should be assayed using a reproducible geometry before each daily use of the instru-ment.
1.
Assay each reference source using.the appropriate instrument setting (i.e., Cs-137 setting for Cs-137).
2.
Measure background level at same instrument setting.
i
l
{1 9-Calculate net activity of each source subtracting out back-3.
ground level.-
For each source plot net activity versus the day of the year 4.
on semi-log graph paper.
5.
Log the background levels.
Indicate the predicted activity of each source based upon 6.
decay calculations and the + 5% limits on the graph as illustrated.
Repeat the procedure for the Cs-137 source for all of the 7.
commonly used radionuclide settings.
Variations greater than + 5% from the predicted activity 8.
indicate the need for instrument repair or adjustment.
Higher than normal background levels should be investigated to A 1"-
9.
determine their origin and eliminated if possible by decontamination, relocation, etc.
,k l
i
1
_,,e Facilities and equipment 5
Facilities located on fifth and upper most floor of the hospital consist of three air conditioned rooms divided as follows.
- a. A storage (" hot") room which has a lead wall on two sides, containing a table covered with formica where isotopes will be kept in original lead containers shielded by 2 X 4 X 8 inches bricks; a protective lead barrier with lead 61 ass; a table monitor, a por-table monitor with ran6e up to 2.5 R/hr, remote hand-ling equipment, a lead shield for generators, labeled waste liquid containers shielded by lead, a lead lined refrigerator, and a lead apron.
- b. A dia6nostic room containing Picker Dynacamera 4/15/37 Whole Body System with Mini Computer system, a portable survey meter with range up to 1 R/hr, a stainless steel l
waste container, physician desk, patient and isotope records.
- c. A processor room with stainless steel table, two sinks with round corners, a fume extractor, and an automatic Kodak processor, d'.. A counting room where doses will be calibrated, and uptakes measured, containing a dose calibrator, a well-counting scintillation detector and scaler, a thyroid uptake unit, patient recono: files,a portable survey 7pasd4 with range up to 100 mr/hr, a desk and a examinin6 table.
n
- e. A small hall communicates rooms b, c and d.
- f. across the hall and in front of room d, another room is available'with desks use as waiting room or for interview k,.
Hof patients.
A stretcher is available.
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(amera Nucl ar Medicine e
Laboartory (12 X 18)
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l Hall dock
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i Refri-airi: a1) 4 p p, 33,y t
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slution table m
Procassor Room
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Hall IV unit z'.
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Labellin l
brator table EndoccoW 3<3a \\
equnter Sink l
j m.___ _._ _ ___..
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IN SERVICE TRAINING FOR RADIATION WORKERS AND ANCILLARY HOSPITAL PERSONNEL ACCORDING TO 10 CFR 19:12 INSTRUCTIONS TO WORKERS IN A RESTRICTED AREA. IT WILL INCLUDE:
- a. Information of storage, transfer, or use of radioactive mate-rials or radiation in the restricted area.
- b. Instructions'in health protection problems, associated with exposure to radioactive materials and radiation,
- c. Precautions or procedures to minimize exposure.
- d. Function and purpose of protective devices.
'si
- e. Instructions in observation of provisions of Commission Regula-tions and licence.
- f. Instructions of their responsibility to report promtly to the licencee any condition which may violate commission regulations and licence or unnecessary exposure to radiation or to radio-active material.
- 6. Instructions on how to respond appropriately to warning made in case of unusual occurrence or malfunction that may involve exposure to radiation or radioactive material.
- h. Advise on radiation exposure records.
- 1. Training will also include on the job and in-service instruc-tions in:
- a. Calibration and use of instrumentation
- b. quality control procedures for labeled radiopharmaceuticals
- c. Radiation assay measurements and Molybdenum determination
- d. diagnostic studies as to instructions and preparation of patients, purpose of procedure, new techniques or re-evalua-tion of performance of those already established.
PROCEDURES FOR ORDERING AND RECEIVING RADIOACTIVE MATERIAL:
I Ordering The nurse trained in Nuclear Medicine or the technolo61st will place orders for radioactive materials and will ensure that the requested materials and quantities are authorized by the licence and that possession limits are not exceeded.
II A. Routinely used materials:
- 1. Have written record to identify isotope, compound, activity levels, supplier, catalo6 number, date when the radioactive material should be received in the Nuclear Medicine Facility.
- 2. Refer to these written records when opening and storing the radioactive shipment.
B. Materials for therapeutic use:
- 1. The nuclear medicine physician who will perform the procedure will 61ve written instructions as to isotope, compound, amount of activity level, and date when it will be administered.
- 2. The person ordering the material will make reference to this written report when placing the order.
- 3. The physician written request will be referenced when receivin6. openin6, and storing the material.
- 4. Assay dose prior to administration.
C. Maintain records for all orderin6 and receipt procedures.
III DELIVERY OF RADIOACTIVE PACKAGES DURING NORMAL WORKING HOURS:
- 1. Carriers will be instructed to deliver radioactive packages directly to Nuclear Medicine Laboratory.
- 2. Arrival of shipments shall be notified inmediately to laboratory personnel or physician in change.
Precautions should be taken to avoid unnecessary exposure to radiation.
Package should be checked for spills or contamination.
Records of surveys should be maintained.
- 3. Written instructions for opening packages with radioactive materials will be Civen.
IV Instructions to follow when receivin6 radioactive shipments during off duty hours:
Written instructions will be given.
The security personnel and chief nurse supervisor will be informed of these policies and instructions.
They will accept packages accordin6 to procedure outlined in memorandum sent to this personnel.
F7 MEMORANDUM f
From: Hospital Administrator From: Nuclear Medicine Director To: Security Personnel Chief Nurse Supervisor
Subject:
Receipt of packages containing radioactive material Any packages containing radioactive material arriving between 3:00 PM and 7:00 AM or on Holidays, on Saturday and Sundayc, shall be ci6ned for by the Security Guard or chief hospital nurse supervisor on duty, and taken immediately to the nuclear medicine department. Unlock the door, place the package in the hot room ar'n of the nuclear medicine laboratory, and relock the labcratory door.
Precaution: If the package ic wet or appears to be damaged, immediately contact the hospital hadiation Saf(ty Officer
( or Nuclear Medicine Physician).
Ask the carrier to remain at the hospital until it is determined that neither he nor the delivery whicle is contaminated.
Radiation Safety Officer Office Telephone Home Telephone Nuclear Medicine Physician
, Office Telephone Home telephone L
V PROCEDURES TO BE FOLLOWED WHEN OPENING PACKAGES WITH RADIOACTIVE MATERIALS
- 1. Inspect package visually for any si6n of damage (wetness, crushed, etc.) If damage is noted, stop procedure and notify Radiation' Safety Officer. Monitor External radiation levels within 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> after receipt during workin6 hours or within 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> of receipt after working hours.
- 2. Put on gloves to prevent hand contamination.
- 3. Measure exposure rate at 3 feet.from package surface and record.
If activity greater than 10 MR/hr. stop procedure.
Notify Radiation Safety Officer.
- 4. Measure surface exposure rate and record.
If activity greater than 200 mr/hr. stop procedure and notify Radiation Safety Officer.
- 5. Monitor for surface contamination with wipe test.
Notify Radiation Officer if contamination exceeds.01 uci/100
- 6. Open the outer package (follow manufacturers directions) Remove packing slip.
Open inner packa6e to verify contents (compare requisition, packing slips and label).
Check inte6rity of final source container (inspect for breakage of seals or vials, loss of liquid, discoloration of package meterial).
In case of therapy doses compare with physicians, written request.
- 7. Wipe external surface of final source container with moistened cotton-swab or wipe test smear, assay and record.
- 8. Monitor the packing material and packages for contamination before discarding.
- a. If contaminated, treat as radioactive waste.
- b. If not, obliterate radiation
- labels before discarding in regular trash.
- 9. Maintain records of results of choking each package.
- y.. m.~,. -._
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RADIOACTIVE. SHIPMENT RECEIPT REPORT o
1.
Survey date:
Time:
Surveyor:
- 2. Condition of package:
Ok wet Punctured other Crushed
- 3. Radiation units of label mr/hr
- 4. Measured radiation levels
- a. Package surface mr/hr
- b. 3 feet from surface mr/hr
- 5. Agreement of packing slip and vial contents:
no difference
- a. Radionuclide yes no difference
- b. Amount yes no difference
- c. Chem form yes
- 6. Wipe results: a. outer conhts
- b. Final Source Container
- 7. Survey results of packins material and cartons __mr/hr CPM
- 8. Disposition of package after inspection _
- 9. If NCR carrier notification required: Time Date Persons notified
t-PONCE DISTRICT HOSPITAL NUCLEAR K:DICINE LABORATORY SURVEY REPORT RADIOISOTOPE SHIPMENT AT ONE FOOT FROM SIDE..
.MR/h SIDE I (ON CONTACT)..
...MR/h SIDE 2 ("
).
.MRen SIDE 3 (
)
.MR/h SIDE 4 ("
).
MR/h 10P
("
).
.MR/h TOTAL ACTIVITY:
euries INSTRUMP.NT USED:
DATE,,,__ _ _,..
SURVEYED BY:
s-e RADIATION PROTECTION PROGRAM:
- 1. Isotopes will be used in a precalibrated form.
- 2. For short, half life isotopes obtained from 6enerator, a dose calibrator is available for assay.
Generators are kept for decay in a separate room kept locked and identified with radiation sign.
Radiation sign is posted in the laboratory.
- 3. When radioactive shipments are received, packages should be delivered to the Nuclear Medicine Laboratory Hot Room.
When processing package, use lead apron, gloves, and remote handling device.
It should be checked'for damage,breaka6e, or spilla.
Check outer containers for contamination, and keep records.
- 4. Radioisotope material will be kept in isotope lead nest, or in lead-lined refrigerator when indicated,' or in isotope lead brick nest.
Generator is kept behina lead chield.
Prepare and dispense labeled radiopharmaceuticala behind crystal lead shield.
Transport radioactive material in shielded container.
- 5. Solid radioactive waste should be kept in labeled waste con-tainer.
Keep radioactive solutions in shielded containero, and identify by labeled compound, radioisotope,date, activity.
- 6. The laboratory will be surveyed re6ularly for contamination.
Survey program will include the following:
a) Daily routine wipe test in arena used for generator elution and lootope preparation.
b) Laboratory survey of all areas for contamination with portable meter or wipe test weekly.
- 7. Personnel will be surveyed frecuently for contamination.
Personnel will une film bad es at all times, at chest or C
waint level.
- 8. Store pornonnel monitorin6 devices on low background area when not being worn to measure occupational exposure.
Wear TLD ring bad en during elution of generator, preparation, 6
assay, and injection of radiopharmaceuticala.
7_-________
/
o
- 9. counting equipment, enviroment, hands, and c1'othes should be checked for contamination.
Radiation background should be checked daily for each instrument and records.kept.
- 10. Eating and use of cosmetics will not be allowed in the laboratory.
- 11. Smoking is prohibited in radioisatope laboratory areas.
- 12. No mouth pipetting is permitted.
Automatic pipetter will be used.
- 13. Remote handling equipment shall be used.
- 14. Shielding containers will be used when handling radioactive material for calibration, or when carryin6 isotope from one place to another,
- 15. Syringe shields will be used durin6 injection of radioactive material.
- 16. Rubber gloves, gowns, film badges will be used during manipu-lation and use of isotopes. After handlin6 isotopes wash hands before and after removing gloven.
- 17. Gloves and decontamination colution should be used for wanhin6 materials.
- 18. In case of spills, turn off air circulation system, notify all persons in the room, and the radiation protection officer.
In case of liquids, drop absorbent paper over area, mark areas with red pencil to indicate contamination.
Also refer to Booklet Emergency Handling of Radiation Accidents, 1972-AEc.
-19. Patients abould be taken to the Radioisotope Laboratory for dose administration.
- 20. Each individual patient done shall be annayed in the done calibrator just prior to administration.
For therapeutic doses, check patient's name, radionuclide, chemical form, activity, and refer to written order of physician to administer dose.
- 21. The registered nurse trained radioisotope technician or the Nuclear Medicine technician may calculate and administer radioisotope doses under supervision of nuclear' medicine physician.
/
+
- 22. Female patients should be questioned for possibility of l
pregnancy.
If condition is present, contact the attendin6 l
physician.
Radioactive materials will not be administered to pregnant patients.
l'
- 23. Hospital personnel will receive instructions regarding protection against radiation when hospitalized patients receive radioisotopes.
l
- 24. Only authorized personnel will have access to hot room.
l The laboratory will be locked when no personnel is present.
l
- 25. Radiation precaution signs should be posted in areas of i
radiation.
i
- 26. License should be-posted on Bulletin Board.
W
- 27. Manual of Nuclear Medicine procedures should be available.
i I
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js RADIATION PROTECTION POLICY / PROCEDURE 1
Policy: To provide maximal protection a6ainst hazard to patients
]
and personnel when using radioisotopes, by reducin6 radia-tion exposure as low as reasonably achievable.
i Procedure:
)
i
- 1. Never expose a human bein6 to radioactive material for demos-tration purposes only.
j' i
- 2. Never remain in hot room for more than necessary durin6 work.
i i
j
- 3. Always wear a film badge in Nuclear Medicine Laboratory.
- 4. Personnel radiation monitoring j
- 1. Whole body Film bad e and TLD ring services will be supplied 6
regularly for persons workin6 in the laboratory.
Reports j
of radiation exposures will be evaluated by the Radiation Safety Committee.
Records should be kept for each person.
- 2. Your film badge radiation monitor is 22ur responsability.
a) film badge must be worn at all times on duty.
b) When going off duty, place film bad e in assi ned area, 6
6 c) rote badge reading, includin6 cumulative dosa6e monthly.
- 5. No personnul aren is permitted in radiation areas unless pro-perly badged and protected.
ia
- 6. Isolate therapy patients, if hospitalized.
Children are not permitted as visitors.
Pre 6nant visitors or workers are not permitted.
Other personnel and persons keep 3 feet distance from patient.
Instructions are 61ven to personnel and patients receiving therapy.
Special radiation precau-tions will be followed.
1
- 7. Be sure proper verbal comunication with patient in available and written instructions before therapy in 61ven regarding all these radiation precautions.
- 8. Know written policies or procedures for receipt for radio-active shipmenta, disposal, handlin6 of radioisotopea.
- 9. Recorda:
Keep records of all radioactive shipmento; radioactive dosen administered, disposal of radioactive wastes, calibration of equipment and date of repaira, raciation background recording and monitoring, quality control procedures, i
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RADIATION PROTECTION OF PERSONNEL DURING ELUTION OF GENERATORS AND HANDLING OF ELUATES:
Generator in placed behind lead brick wall.
Lead apron and gloves will be used durin6 elution.
Lead lined 30 cc vial shield will be used for elution.
Vials will be handlea with remote device when handling radioactive material for calibration.
Gamma vue ayringe shileda 5, 10, 20 cc are available.
Whole body monitorin6 is done with film badges; and TLD ring monitora to measure extremity exponure are also available (monthly reporta).
personnel will be surveyed for contamination after clution and after preparin6 Tc labeled compoundo.
During accidents or spilla check raciation levels with aurvey meter.
Shut off air circulation ayatem to prevent spread of contamination.
All persona in room will be notified, na well as the radiation protection officer.
Une 6own and gloven.
Drop abuorbent paper over liquid spillu.
Mark area with red pencil or close off the contaminated area.
For dry opilla, une wet absorbent paper over area with decontamination solution.
If there in contamination of personnel or an indivi-dual, follow recommendations on yellow booklet "Emer6ency Handlin6 of Radiation Accidento Gasen-1972" (USAEC), which is at hand.
The manufacturer's procedurou for clution and nanny will be followed.
Written procedures for detection of Mo 99 contamination will be followed.
USE OF MOLYBDENUM 99M/ TECHNETIUM 99M GENERATORS EINTIONS Every elution will be assayed for Tc 99m activity and Mo 99 contamination using the Deluxe Isotope Dose Calibrator II Model 340056 The eluates will not be used if there is more than one microcurie of Mo 99 per mil 11 curie of Tc 99m or more than 5 uo of Mo 99 per dose of To 99m administered.
ACCES0 RIES AND PACILITIES TO BE USED:
Mo 99 Generator in current une wil be located and eluted on a table in hot room.
It will be protected with lead shield. A lead lined 30 cc vial chield will be used when elutin6 Tc 99m.
Gamma vue TM ayringeo 5, 10, 20 cc are available to be used 6 oven will be used durin6 when handling doses. Lead apron and 1
milking 6enerators.
Remote handlin6 of vial for annay of Tc 99m and Mo 99 will be used.
A Camma vue vini shield (56-234) in also available.
Whole body film bad 6en and TLD rind monitors will be used by personnel.
After their une, generators will be allowed to decay for 40 days in a Deparate stora6e room.
Radiation signs will be placed at thin aren and on each cenerator.
Each one will be marked with daten it may be removed from decayin6 area.
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RADIATION MONITORING DOSIMETRY REPORTS Film bad es and TLD rin6s services by:
6 Siemens Gammasonics, Inc.
Health Physica Services Box 1367 Des Plaines, Illinoio 60018 Tel 800-323-6015
SMEAR TESTS
- 1. Entrance to Hot Room (Refri erator top) 6
- 2. Hot Room (Elution table)
- 3. Camera imaging (Collimator face)
- 4. Inner hall (waste top)
- 5. Processor Room (sink)
- 6. Examining Room (area) (table or desk)
- 7. Hall
- 8. Hall-Entrance counting room
- 9. Well counter desk
- 10. Calibrator /
- 11. Labelling table
- 12. Sink,
- 13. File
- 14. Uptake unit
- 15. Desk
- 16. Endoscopy Room
- 17. Stress Test Room J
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SEALED SOURCE LEAK TESTING OF RADI0 ACTIVE STANDARDS AT NUCLEAR MEDICINE LABORATORY 9
Procedure: Wipe (Smear) Test Wipe'all external surfaces of the source, including the source seal area, with.a piece of H2O moistened filter paper.or other suitable " swab".
Measure the total activity-on the paper or " swab" with an appropriately calibrated gamma' scintillation counter.
Care should be taken to assure proper counting time for reasonable statistical validity of values obtained.
Record test results in proper source log.for future reference.
In the total' activity smeared from the source is less
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than the previous smear test, and 1ess than 5 X 10-4 micro-curies, then the source shall be considered leak free.
If
- the total activity measured is significantly more than the previous test value, then the source should be removed from-service-until.the source leakage can be confirmed or other source of contamination found. (even though the detected quantity may be less than that specified on the user's license.for reportable source leakage).
A " hot" smear
'should be checked every few days to determine if the acti-
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If two smears at 7 day intervals reveal positive values, the
. source should be disposed of or returned to NEN for evalua-tion.
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RADIATION PROTECTION SURVEY
- 1. Radiation protection written rules and regulations are estatlished.
They should be posted in laboratory.
Check for.ompliance with NRC licence specifications,
- 2. Radiation protection surveys should be carried out every 6 months by the radiation safety Committee R.S.C.
- 3. Radiation protection pro 6 ram should be re-evaluated every three months by the radiation Safety Officer or the radiation physicist and determine if it is followed as indicated.
- 4. Records of receipt, stock amounts and disposal of radio-active material should be kept.
- 5. Records of patient identification, dose, procedure done, date, should be kept.
- 6. Bring to attention of personnel any non-compliance with laboratory regulations and of radiation protection program.
Instruct other hospital personnel as needed.
Give adequate training to laboratory personnel.
- 7. Determine needs of necessary radiation protection accessory equipment.
- 8. Check radiation monitors.(portable survey meters) and calibrate annually.
- 9. Check personnel radiation exposure records every three months.
- 10. Check radiation levels of daily and weeklly laboratory surveys.
Establish if adequate decontamination procedurc has been followed in cases contaminations or radiation spills.
- 11. The radiation safety committee shall work in cooperation with the hospital safety committee.
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W WASTE DISPOSAL A. In older to reduce volume of radioactive waste, segregate radioactive from non-radioactive waste materials.
Give instructions to laboratory personnel in this respect.
B. Solid material will be allowed to decay to back round level 6
in lead nest used for this purpose only or in lead waste container.
A storage room will be used for decay of larger volume of radioactive wastes and Mo99m/Tc99m generatore.
C. Generators Mo99/Tc99m will be kept for decay in the stora6e room and labeled with date they can be dispossed off according to half life of the isotope.
The generator columm will be segregated and should be monitored separately for radiation
-level.
If still radioactive,it will be kept for a lon6er time-in lead container.
When it is in back6round levels it is dispossed in ordinary trash.
D. Liquid material will be kept in original lead protected vial and allowed to decay to background levels in lead nest.
Liquids may be disposed also by release into monitory sewera6e in conformance with section 20: 303 part 20, Title 10 of code of Federal re6ulations.
E. All wastes will be surveyed prior to disposal (with all shieldin6 removed) Records will be maintained.
The Radiation Safety Committee will review and implement the adequate procedures.
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DECAY-IN-STORAGE ROOA
- 1) Refer to diagram of area to incicate type, location, chieldin6 available in area in order to reauce raaiation levels according to 10 CFR 20.105. (Permissible levels of radiation in unrestrictea areas).
2)
Security measures for decay-in-storage area are specified lauq
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an every time material is sent for storage or disposen off.
3)
Radiation levels in this area will be surveyed regularly and recorded in diagram sheet.
4)
Procedure for monitoring waste to assure that is has decayed to background levels prior to cisposal:
- a. The waste will be monitored in a low back round area.
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- b. Monitor it with the G.>I.
survey portable meter with range 0-100 mr/hr, and usin6 the most sensitive scale.
(Survey meter apptopriate for contamination levels).
- c. Remove all shieldin6 Prior to monitoring.
- d. Keep records of these surveys as required under 10 CFR 20.
- e. When waste is in background levels it can be disposed off in ordinary trash.
- f. Remove or erase all " radioactive" signs before disposal.
- g. All waste will be surveyec with all shielding removed prior to disposal.
- h. Radiation safety officer will review and implement adequate procedures.
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