ML20214H697
| ML20214H697 | |
| Person / Time | |
|---|---|
| Site: | 07002199 |
| Issue date: | 05/14/1987 |
| From: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | James Smith VETERANS ADMIN. MEDICAL CENTER, WASHINGTON, DC |
| Shared Package | |
| ML20214H692 | List: |
| References | |
| 107167, NUDOCS 8705270470 | |
| Download: ML20214H697 (2) | |
Text
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14 M!\\Y 1987 License No. SNM-1605 Docket No. 070-02199 Control No. 107167 V. A. Medical Center ATTN: James J. Smith, M.D.
50 Irving Street, N.W.
Washington, D.C.
20422 Gentlemen:
Please find enclosed an amendment to your NRC Material License.
Please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or questions, please notify the Region I Material Licensing Section, (215) 337-5239, so that we can provide appropriate corrections and answers.
Please be advised that you must conduct your program involving licensed radioactive materials in accordance with the conditions of your NRC' license, representations made in your license application, and NRC regulations.
In particular, please note the items in the enclosed, " Requirements for Materials Licensees."
Since serious consequences to employees and the public can result from failure to comply with NRC requirements, the NRC expects licensees to pay meticulous attention to detail and to achieve the high standard of compliance which the NRC expects of its licensees.
You will be periodically inspected by tSC. A fee may be charged for inspections in accordarce with 10 CFR Part 170.
Failure to conduct your program safely and in accordance with NRC regulations, license conditions, and representations made in your license application and supplemental correspondence with NRC will result in prompt and vigorous enforcement action against you.
This could include issuance of a notice.of violation, or in case of serious violations, an imposition of a civil penalty or an order suspending, modifying or revoking your license as specified in the General Policy and Procedures for NRC Enforcement Actions, 10 CFR Part 2, Appendix C.
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V. A. Medical Center f00[
We wish you success in operating a safe and effective !icensed program.
Sincerely, Or3 cir.?1315aed Eyf JchnI. 01cnn John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section B l
Division of Radiation Safety and Safeguards l
Enclosures:
1.
Amendment No. 10 I
2.
Requirements for Materials Licensees l
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DRSS:RI DRSS:RI Foster /kl lenn 5/ll/87 5/ ll /87 0FFICIAL RECORD COPY ML SNM-1605/LTR - 0002.0.0 05/09/87
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Medirl C;nt:r O 50 trying Street, NW.
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Washington D.C. 20422 K Veterans Administration in Reply RefeM.8/115 Ma,rch 25, 1987 Mr. Thomas T.
Martin, Director Division of Radiation Safety and Safeguards US Nuclear Regulatory Commission Region I 631 Park Avenue King of Prussia, PA 19406
Reference:
License Nos.
08-00942-05 08-00942-04 iSNM :1605M SUBJ:
Response to Notice of Violations 1.
In response to your letter dated February 19, 1987, the enclosed report addresses the particulars in the Notice of Violations, and it provides a summary of our actions to correct the violations and of our efforts to assure that the violations do not recur.
2.
We appreciate the importance of the mission and goals of the Nuclear Regulatory Commission, and we are making every
~
effort to assure that our radiation safety program is consonant with your directives.
3.
The Chairman of our Radioisotope and Radioactive Drug Research Committee (RI&RDRC) has recommended that an audit of our radiation safety program be conducted by private sector health physics specialists.
Accordingly, we are contracting to retain Health Physics Services, Inc. (HPSI) for this purpose (Attachment A).
We believe ourselves to be in full compliance now, with your requirements, and we expect that the audit by HPSI will verify this.
4.
To enhance our program, Mr.
Ronnie R.
Davis, Health Physicist, working with the Radiation Safety Officer, is registered to attend a two week course on Medical X-ray Survey Techniques under the auspices of the U,.pg Army at San Antonio, Texas, beginning March 3k,,-LE87;Pi[ Attachment B)
)' Unidi a 27 APR 1987 a mdi ubla] COP-Y" 107167
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On March 17, 1987, our Radiation Safety Officer, Mr.
John Bowman announced that he will leave our Medical Center for a new position to begin April 13, 1987.
Although we immediately began a search for a qualified Health Physicist to replace him, we may not succeed in filling the position by April 13.
(6 C CWelsubmi th a ~(re'quis E[h~tleihmkd((f_or iin '~ amen'dain~E[tM
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our licensure "t'o'" permit" James 1J. J Smith, u M.D.r - Chairman of ~ ~
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the RI&RDRC and Chief of the Nuclear Medicine Service, to serve as Acting Radiation Safety Officer on an interim basis.
We will assure that he has time to act in this capacity.
Dr. Smith was formerly consultant to the New York City Board of Radiation Control, and he is currently a Clinical Professor of Radiology (Nuclear Medicine) at the George Washington University School of Medicine and Health Sciences.
He will be assisted in this work by Mr. Ronnie R.
Davis and Mr.
George L.
- Colouris, Supervisor of Nuclear Medicine Technologists.
Sincerely, M
J AVERS 2edical Center Director Enclosure (s)
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v VETERANS ADMINISTRATION MEDICAL' CENTER Washington, D.C.
Response to Notice of Violations
Reference:
Inspection No. 86-01 NRC Letter Dated February 19, 1987 Licenses:
08-00942-04, 08-00942-05, SNM-1605 A.
Security Violations (Failure to secure licensed material against unauthorized removal).
We have notified all users that they must meet the requirements of 10 CFR 20.207 and that failure to secure radioisotopes may result in restrictions to or loss of, their permits.
Routine checks are made to assure compliance. (Attachment D, #5)
The key to the 60- cobalt console in Radiation Therapy Service is now secured when the console is unattended.
B.
Failure to evaluate concentration of effluents released to sanitary sewer and atmosphere.
1.
Sanitary Sewer Release.
Instructions on all sink disposal logs require users to release no more than 100 microCi'per day.
If all users released 100 microCi per day, every day (20 days per month) then the following maximum quantity would be released. per year 13x100x20x12=312,000, microci or about one-third - of the maximum allowable annual release under 10 CFR 20.303(d) for all licensed and other radioactive material excluding tritium and 14-Carbon.
We believe this ' demonstrates-compliance with 10 CFR 20.303(d).
This calculation-had been performed previously, but we had no record of the calculation to show the inspector.
We have analyzed the effluent quantities released to the sanitary sewer.
Our Medical Center uses on the order of 1,000,000 cu ft of water per month (according to Engineering Service estimates).
This quantity of water usage shifts the question of compliance from the maximum concentrations allowable under Table I, Column 2.
Appendix B of 10 CFR Part 20 (as references in 10 CFR 20.303(b)(1) to compliance with the gross total release of licensed and other radioactive material as allowed by 10 CFR 20.303(d).
We are collecting and tallying the sink disposal records to demonstrate compliance.
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Atmospheric Release.
The Hepatitis Research autoclave was tested on December 16, 1986.
Air was sampled for twelve hours at 4 liters per min.
The sample was counted in a well: counter with 46% efficiency
'for 125-I..
The.results are summarized-below:
The airbone concentration ~of 125-I was less than 6.4x10-12' microci per ml A = Concentration Hours:
7.7x10-11.microCi-hrs /ml B = MPC Hours for 1251: 7.0x10-7 microCi-hr/ml Fraction of Annual-MPC u' sed -in one process (A/B):
C
=
1.1x10-4 This process is performed no more than twice_perLmonth.
If it were performed ten times per month, then wei would - use 10x121.1x10-4 1.32x10-2_MPC.
This is less than 2 percent
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of the annual effluent limit.
Since all 125-I involved in this process is bound, _the above:
results are consistent with our expectations.
C.
Failure to follow requirements for procedure approvals.
1.
Nuclear Medicine Service has worked with the RI & RDRC r
through the RSO to develop a
comprehensive list of procedures.
However, the reflux renal patency study was identified during the inspection as not_having been included on the list.
Although the Committee considers-incorporation of new FDA approved uses of radioindicators in its quarterly.
meetings, it is-also assiduous in reviewing'such procedures on an ad hoc
- basis, in the interim _ between quarterly meetings, for current use of procedures _needed for immediate patient care.
Thus, all Nuclear Medicine Service - studies are approved, 'in advance, by the RI&RDRC. (Radioisotope and Radioactive Drug Research Committee).
2.
Failure to document a spill.
To assure that compliance is documented in the future, the RSO is providing an incident report form, to be filed in the Radiation Safety Office.
There have been no radioactive spills subsequent to the November, 1986, NRC inspection.
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- 3. Food in Research Laboratories. (Eating and drinking. in radiation areas).
It has been reiterated to users that
- food, beverages, smoking and the application of cosmetics in the Research' Laboratories will not be tolerated (Attachment D,
- 1 & 2),
(Attachment E).
Routine inspections combined with user audits, determine compliance with these regulations.
4.
Quality Assurance Tests For Dose Calibrator a.
Linearity tests were performed on 11/19/86 and 2/4/87.
Tney will continue to be performed, as required, on 4/28/87, 7/28/87 and 10/27/87.
Verification of linearity across the entire range of activity is charted and entered in our Service log book.
b.
The daily constancy test,has been modified to comply with the procedure identified in our license application (Appendix D
of Regulatory Guide 10.8, Rev.1). Constancy verification is charted and entered in our Service log book.
c.
Radiation Service Organization Inc.
conducted an accuracy check of our dose calibrator on 11/17/86 that-showed the instrument to be performing properly and to be within the +5% limits of error specified in NRC Regulatory Guide 10.8,~(Attachment F).
D.
Inadecuate action on Thyroid Uotake of Research Worker (Failure to maintain records of bioassay evaluation)
We have modified our standard operating procedures to define explicitly the actions to be taken when an elevated uptake is discovered in an employee (for follow-up of individuals with elevated thyroid uptakes).
The -revised protocol includes an incident report. (Attachments G & H)
E.
Failure to maintain records of leak test results.
Loss of these records was caused by a computer malfunction.
Printed copies of these records are now maintained, pending assurance that the computerized system is reliable.
We have submitted a request for an upgrade to the computer system that will add another layer of protection against loss of data.
Health gtysics Service 3,Incq jo$
4 Research Place, Suite 140 RockvWe, Maryland 20850
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Phone: (301) 6701818 Toll free: 800-6384488 l
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January 27, 1987 Dr. James J. Smith Attachment #A Chief, Nuclear Medicine Service VA Medical Center 50 Irving Street, N.W.
(115)
Washington, D.C.
20422
Dear Dr. Smith:
Health Physics Services,.dnc. (HPSI) is pleased to submit a proposal pursuant to your request for the performance of a management / performance audit of your Radiation Safety Program.
HPSI is uniquely qualified to perform such an audit having successfully supported a number of major medical facilities with similiar comprehensive audits.
These audits have frequently followed Nuclear Regulatory Commission (NRC) inspections and were accomplished at the NRC's suggestion.
The NRC recognizes and accepts the quality and professionalism of our services.
Two recent audits of major medical facilities have been in the metropolitan D.C. area, i.e. The Washington Hospital Center and the George Washington University Medical Center.
We will, if requested, provide references for both of these organizations.
HPSI presently provides comprehensive radiation safety services for over 150 hospitals.
Our experience, developed over 16 years of consulting, can be applied to the prompt and successful resolution of your radiation safety problem.
In addition, our staff includes several ex-NRC professionals including the previous Chief of the NRC's Medical and Academic Licensing Section.
Further, the entire staff is well acquainted with NRC's rules, regulations, policies and personnel.
HPSI proposes to perform a management and performance audit of the Washington, D.C. VA Medical Center (VAMC) Radiation Safety Program from the standpoints of NRC regulations and licensing, local requirements, and acceptable safety practices.
To accomplish this objective, HPSI will undertake the following tasks:
a.
Review and evaluate the VAMC's NRC license (s),
application (s) and inspection history, b.
Review and evaluate VAMC's radiation safety manuals and instructions for adequacy and correctness.
c.
Review and evaluate staff qualifications and resources, particularly those assigned to the Radiation Safety Office, for adequacy to meet the requirements.
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O VA M dical Center
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' Washington, D.C.
d.
P.eview and evaluate radiation safety training and education
- programs, Beview and evaluate the responsibilities of radiation users e.
to carry out the Safety Program on a day-to-day basis including' radiation therapy, nuclear medicine and clinical laboratory.
f.
At completion of the project, provide an oral debriefing and a written report of findings and recommendations to the Radiation Safety Committee.
A detailed outline of our audit procedure is attached.
The total time to complete thd project will be 1 to 2 months and will require 40 to 60 hours6.944444e-4 days <br />0.0167 hours <br />9.920635e-5 weeks <br />2.283e-5 months <br /> of professional time.
PPSI will undertake these tasks for a firm contract-fee of $2,500.00 I hope you find this proposal satisfactory.
If you have any questions, please contact me at (301)670-1818 Sincerely, HE,TH P YSI S
VICES, INC.
i, William J Walker, Ph.D.,CHP Senior VIce President
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POSTGRADUATE ATO INSERVICE TRAINING CO*MITTEE e s Attachment #B John O.
Bov.r.an s :-
Radiation Safety Office (115)
TRAINING REQUEST 1.
It is requested that the Committee consider this request for training for:
NAME: Ronnie R.
Davis 0FFICE PHONE Ext.7383 or 7595 ADDRESS: 50 Irving St. N.W. Washington, D.C.
20422 POSITION TITLE Health PhysicisMAILING SYM50L 115 DATE CAME TO VA 9/18/E3 2.
Tnis is a request to attend tne following meeting:
NAME OF MEETING:
Medical X-rav Survev Technicues TO BE HELD IN (City / State) San Antonio, Tex DATE March 29thr April 10,19 3.
It is estimated tna costs will be as follows:
TRANSPORTATION ( Air / Bus / Train /POC) $ 266.00 Ground S 30.00 t
PER DIEM 13 days at 5 75.Obday for a total of
$975.00
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REGISTRATION 5 Free GPF Funds in tne amount of may be used from GPF d to supplement this request.
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JUSTIFICATION AND SIGNATURE OF SUPERVISOR / SERVICE CHIEF This is the only training course that adecuately prepares cne for x-ray and fluoroscope inspections.
.v.r. Davis needs this course as a part of his develorment and training as a health physicist.
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$500.00 367/80161.007 CP 185 TRANSPORTATION PER DIEM NTE $ 400.00 3670160.007 CP 918 REGISTRATION NTE 5 -
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WM?tEW OF VANC RADIATION SAFETY PROGRAM OUTLINEOFGENERALAPPgCH Complete review of licensos, applications, procedures, safety 1
manuals and inspection correspondence.
- Identify key commitments made to NRC
- Pinpoint areas that may have contributed to previous NRC violations
- Identify those areas where the level of performance is not well defined
- Recommend changes as necessary Review, with the RSO, radiation safety staffing and responsibilities.
- Are resources adequate for compliance?
- Are responsibilities adequately defined?
- Do all staff members understand the responsibilities?
Review user 's responsibilities with radiation safety staf f and
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selected users.
- Visit facilities
- Do users understand responsibilities?
- Are users capable of meeting requirements?
- User's attitude toward responsibilities
- Relationship with radiation safety staff Review educational programs.
- Adequacy
- Frequency
- User response
- Recommend changes as necessary Make preliminary determination of in-house deficiencies.
- Meeting key commitments to NRC
- Staffing
- Equipment / facilities
- Written guidance
- Other deficiencies
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- Identify cause(s) if possible
- Solution (s) if possible Preliminary review with the Radiation Safety Committee.
- Committee / Management perception of the Radiation Safety Program
- Discuss changes in the preliminary approach outline i
Develop final report
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- Meeting NRC/ safety goals?
- Identify areas where the ratio of additional effort to increased performance is maximized
- Suggest approaches for improvement in program administration / management
- Suggest changes in-written guidance
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50 trying Street, NW.
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Washington D.C. 20422 M Veterans
%W Administration in Reply Refer To:
688/115 March 25, 1987 Attachment #C Dr. John E.
Glenn, Section Chief Licensing Section US Nuclear Regulatory Commission Region I 631 Park Avenue King of Prussia, PA 19406
Reference:
License Nos.
08-00942-05 " 3 6-blT 08-00942-04 3C
[t3 SNM-1605 SUBJ:
License Amendment i
1.
On March 17, 1987, our Radiation Safety Officer, Mr. John Bowman announced that he will leave our Medical Center for a new position to begin April 13, 1987.
Although we immediately began a search for a qualified Health Physicist to replace him, we may not succeed in filling the position by April 13.
2.
We submit a request for an amendment to our licensure to permit James J.
- Smith, M.D.,
Chairman of the RI&RDRC and Chief of the Nuclear Medicine Service, to serve as Acting Radiation Safety Officer on an interim basis.
We will assure that he has time to act in this capacity.
Dr. Smitn was formerly consultant to the i
New York City Board of Radiation Control, and he is currently a i
Clinical Professor of Radiology (Nuclear Medicine) at the George Washington University School of Medicine and Health Sciences.
He will be assisted in this work by Mr. Ronnie R.
Davis and Mr.
{
1 George L. Colouris, Supervisor of Nuclear Medicine Technologists.
Sincerely,
/A k
- 1<-
/J. P. TRAVERS Medical Center Director Enclosure (s) n p g u s c,nc u n - n.,u,o - vc,c,
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i Attachment #D (J
RULES AND REGULATIONS FOR RADIATION SAFETY IN RESEARC _ LABORATORIES I
( APPLICABLE TO ANY ROOM (S) WHERE ISOTOPES ARE STORED OR USED) i 1.
No eating, drinking or smoking is pennitted in the laboratories.
2.
Laboratories must not be used for any type of activity associated with food - pre parat ion such as heating cof fee on the stove / hot plate, storing edibles in a refrigerator, etc.
3.
Mouth pipetting of radioactive materials is not pe rmitt ed.
4.
No unauthorized person is permitted in laboratories while isotopes are in use.
5.
Refrigerators and freezers containing radioactive materials should be secured by locks, if not, the laboratories containing the radioactive materials must be kept locked at all times unless an authorized user is physically present.
6.
All users of radioactive materials should keep an accurate log of their tracer usage and disposal.
7.
Tracer laboratories should be kept clean and free of radioactive contamination.
In case of accidental spillage, the tracer should be contained and decontaminated promptly.
In case of bodily contamination, the user is urged to call for assistance by contacting the Radiation Safety Of fice (Ext. 7383) or Dr. Lakshman (Ext. 8330).
8.
Because the Nuclear Regulatory Commission has made unannounced visits for inspection, strict local surveillance will be kept in order to ensure that all of the above safety requirements are complied with.
PRINCIPAL INVESTIGATOR DATE
. Attachment #E p.
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RULES AND REGULATI%S FOR RADIATION SAFETY IN RESEAR't LABORATORIES
( ATPLICABLE TO AiY ROOM (S) WHERE ISOTOPES ARE STORED OR USED) e.
1.
No eating, drinking or smoking is permitted in the laboratories.
I 2.
Laboratories must not be used for any type of activity associated with f >od pre pa rat ion such as heating cof fee on the stove / hot plate, storing edibles in a refrigerator, etc.
3.
Mohth pipetting of radioactive materials is not permitted.
.4.
No unauthorized person is permitted in laboratories while isotopes are in use.
5.
Refrigerators and freezers containing radioactive materials should be secured by locks, if not, the laboratories containing the radioactive materials must be kept locked at all times unless an authorized user is physically present.
6.
All users of radioactive materials should keep an accurate log of their tracer usage and disposal.
7.
Tracer laboratories should be kept clean and f ree of radioac tive contamination.
In case of accidental spillage, the tracer should be contained and d ec on t am in a t ed pr om ptl y.
In case of bodily contam inat ion, the user is urged to call for assistance by contacting the Radiation Safety Of fice (Ext. 7383) or Dr. Lakshman (Ext. 8330).
8.
Because the Nuclear Regulatory Commission has made unannounced visits for inspection, strict local surveillance will be kept in' order to ensure that all of the above safety requirements are complied with.
Note:
In, addition to'the principal investigation, this form is signed, as having been read, by all workers in the laboratory.
4 PRINCIPAL INVESTIGATOR DATE 4
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WASHINGTON BALTIMORE 1301) 953-2482 792-7444 l
November 18, 1986 Mr. George Colouris Nuclear Medicine Service i
VA Medical Center Attachment #F 50 Irving Street, N.W.
Washington, DC 20422
Dear Mr. Colouris:
Enclosed is a copy of the results of the dose calibrator energy accuracy test that we performed on November 17, 1986.
That test demonstrated that the dose calibrator was operating properly and that the errors were within the limits specified by NRC Regulatory Guide 10.8.
Please let me know if we can be of any further assistance.
Sincerely, k
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k F. Patterson Medical Service Division j
RSO, INC. trading as Radiation Service Organization R ADI ATION SERVICE ORGANIZATION P O BOX 1526 LAUREL. MARYLAND 20707-0953
3 Nuclear Medicine Service-VA MedicalCenter Washington, DC 20422 Dose Calibrator Accuracy Test November 17,1986 A test for instrument accuracy was performed using the procedures outlined in US NRC Regulatory Guide 10.8. The data and results are outlined below:
Dose Calibrator: Capintec Model CRC-30, SN 30073 Sources Used:
Test Results:
Activity (mci)
Current inst.
Measured Error Assay Date Activity Setting Activity
(%)
Co-57 5.7 SN 2060186A-41 2.632 Co 57 2.650
-0.67 1/20/86 i
Ba-133 0.279 SN 3580581 A-20 0.195 Ba 133 0.201
-2.93 5/15/81 Cs 137 0.211 SN 3560781 A-18 0.187 Cs-137 0.188-
-0.72 7/17/81 Co-60 0.053 SN 3540581 A-18 0.027 Co-60 0.026 3.94 5/8/81 RESULTS AND RECOMMENDATIONS
- 1. The dose calibrator readings for all channels were within the limits (iS%)
specified in NRC Reg Guide 10.8 when measured on ranges appropriate to the activity.
- 2. This test should be repeated at the frequency specified in your radioactive materials license in order to maintain compliance with the license conditions.
George Stefun Radiological Physicist RSO, INC. trading as Radiation Service Organization
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Rndicticn 03fCty Offid/'
Thyroid Uptake Form 1.
Identification a.
Name b.
Department c.
Date 2.
Reason For Monitoring a.
Routine check b.
Required after-Iodination c.
Other 3.
Instruments Used:
a.
Nuclear Data ND62 b.
Thyroid Uptake Probe with 2 inch NaI(Tl) Crystal.
4.
Analyzer Settings:
a.
High Voltage:
580 b.
Gain:
1.9 i
c.
Emin 20 Kev
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d.
Emax 70 Kev e.
Counting Time 5 Minutes 5.
Geometry:
Distance From Neck to Collimator:
2 inches 6.
Calibration a.
Standard Counts b.
Background Counts:
c.
Net Counts d.
Standard Activity nanoCurie (mock 125I) e.
Counter Efficiency (Counts per nanoCurie) 7.
Measurements a.
Neck Counts b.
Background
c.
Net Counts 8.
Calculated Thyroid Burden:
(8.c.)
(7.e.)
nanoCurie 9.
Thyroid Burden Evaluation *:
The action level for 125 I burden is-25 nanoCurie.
If an individual's thyroid burden exceeds the action level, you should question the employee to determine the cause of the increased thyroid burden.
Thyroid burdens of 52 nanoCurie (measured within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> ) of an iodination indicate an exposure exceeding the MPC.
Follow up measurements must be made on anyone who has a thyroid burden exceeding 25 nanoCurie.
Measurements should be taken and recorded each week until the burden is back to normal (10 nanoCurie or less).
Initiate an incident report if the burden exceeds 25 nanocurie.
' ' ' 7 VA'M3 dical' cantor h 1
Radictica Ecfotyf0fficudb Incident Form l
Attachment #H 1.
Date:
2.
Time:
3.-
Location:
4.
Nature of Incident:
1 5.
Employee _ Statement:
I L
1 6.
Results of Radiation Safety Office Investigation:
7 l
7.
Disposition by Radiation Safety Committee:
.... - -