ML20057A259
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UNITED STATES
_f NUCLEAR REGULATORY COMMISSION 4
j REGION I L
e 475 ALLENDALE ROAD KlWC of PRUBS4A, PENNCYLVANIA 19408 FEB. 2 71989 MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Industrial & Medical Nuclear Safety, NMSS FROM:
Stewart D. Ebneter, Director Division of Radiation Safety and Safeguards, RI
SUBJECT:
REGION I INITIATIVES TO ADDRESS PROBLEMS AT MEDICAL FACILITIES During my brief tenure in this position, I have been surprised at the lack of importance medical licensees appear to attach to understandino and following NRC rules and regulations.
In particular, the failure of physicians to accept their responsibilities and perform their duties as Radiation Safety Officer (R50) appears to be the rule rather than the exception.
The problems have most sharply been brought to my attention by several recent inspections of new nuclear medicine or nuclear cardiology private practices.
Our findings at five such facilities are surrrnarized in the attached table.
Every privi.te practice facility that we have recently inspected soon (within three weeks) after initiation of operations is on thisflist. We are forced to conclude that the majority of physicians starting up aliparently highly r
lucrative imaging practices are willing to tolerate lack of equipment, lack of quality assurance testing, lack of an RSO's review of readiness and-lack of training in order to start patient services as rapidly as possible.
The RSO in each case was either a phytician-user or a nuclear medicine physician who agreed to let his name be submitted so that a cardiologist-owner could qualify for a license.
In no case, did the RSO attempt to establish the readiness of the facility to initiate operations nor did the RSO object to startup without required equipment or instrumentation calibration.
In an effort to better ensure that private medical practice licensees are ready to begin licensed activities, Region I has initiated a trial program to verify that all necessary radiation safety requirements have been satisfied prior to allowing these licensees to treat patients. The basic process will involve implernentation of the following licensing procedures:
1.
Upon completion of the routine license application and review process, the licensee will be issued a license specifically authorizing only the possession of calibration and reference sources as described in 10 CFR 35.57. This will allow a licensee to obtain and use the reference sources necessary to ensure that dose calibrators and radiation survey equipment are performing adequately. A condition in the license will specifically prohibit the administration of licensed radioactive materials to patients.
(Samplelicenseenclosed) 9309130289 930830 l t [,f3 PDR STPRC ESGGEN PDR
2 2.
The licensee's radiation safety of ficer will be required to telephone Region I and to certify that all radiation safety program requirements have been met and that the program is ready to possess and administer radioactive material to patients (see enclosure to be sent with the license). A Questionnaire (enclosed) has been prepared for use in questioning the RSO regarding the program status.
3.
Upon receipt of the RSO's telephone certification that the program is ready to receive and use radioactive material, a materials health physicist will be dispatched to verify the program's readiness (and to validate the information contained in the questionnaire). A license amendment will be signed and issued at the end of the inspection authorizing the licensee's requested activities, if the program is found to be ready.
It is hopec that as confidence in the Questionnaire (as a means of validating reaciness) is established that the on-site visits can be reduced, or eliminated.
In an effort to ensure that R50's are aware of their responsibilities, Region I has also initiated a policy of sending every medical license to the RSO and including a copy of the enclosed " Notice to Radiation Safety Officers" with this copy.
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tewart D. Ebneter, Director Division of Radiation Safety and Safeguards, RI
Enclosures:
2.
Sample License 1.
Table of Findings 3.
Enclosure for Sample License (CAUTION) 4.
Checklist 5.
Notice to RSO's i
CC:
D. Collins, RII C. Norelius, RIII R. Bangart, RIV R. Scarano, RV J. Austin, NMSS
OHMON 1 U tt* 114HTIi1TD Nilt1IM iHtii AI. IH::I Ft:TIi'NS fIF l'ItiVATi< PMt:Tl(*Fil LICENSEE FIIIDINGS HAME Surver Meter
_ _ _ _ Failure to
- Failure nf IGO: Fnatura to lFallura to
- Failure to lFailura
'.o l check source perfo = Das*
lto Septement l possess immintain lank lmetntain Dosa
- train LICENSE HO.
- not possessed l Calibrator
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'revsired
- tast records
- Calibrator
,amployees l check not
- tests prior Safety Program Survey Itest records :
performed
- to patient use l Instruments
- 10CFR35 ?1
- InCFR35 59
- James S.
Chen.HD 1
X X
X X
l 23-28273-01 e
- Dale Edlin. HD X
X X
X 4
X 129-28041-01 l_
lFertig.Lomnita lBlueberg.Lauer.HDs X
X X
l29-28186-01 *
!Jeffrey Weisman.HD :
l X
X X
I X
X 137-28291-01 I
1
- Chrtetien Chinwuba.!
6 HD X
X X,
X X
X l08-28277-01 I
e Licensee wee identitled and agreed to stop activities before patiente dosed e
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1 1
i License No. 29-28330-01 Docket No.
030-30943 Control No. 110056 i
North Jersey Nuclear Diagnostic, Inc.
ATTN: David E. Cohen, M.D.
Radiation Safety Officer 1031 McBride Avenue West Paterson, New Jersey 07424 Gentlemen-please find enclosed 3 sur NRC material license.
please review the enclosed document carefully and be sure that you understand all conditions.
If there are any errors or cuestions, please notify the Re; ion 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 raci oact i vt materials in accordance with the conditions of your NRC license, re:resentations made in your license application, and NRC regu'lations.
In particular, please note the items in the enclosed, " Requirements for Materials Licensees."
This license is being issued in two stages. Please note that this license autneri:es possession of reference standards identified in 10 CFR 35.57 o n 'i y.
You are not yet authorized for byproduct material to practice nuclear me:icine.
Refer to the colored enclosure for further details and instructions.
Sirce serious consequences to employees and the public can result from failure to comply with NRC recuirements, the NRC expect; iice.T.eas to pay meticulous attention to detail and to achieve the high standard of cumpliance which the hRC ex;;;ts of its licensees.
Yea will be periodically inspected by NRC. A fee may be charged for inspections in accordance 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 c',vil penalty or an order suspending, modifying revoking your license,as specified in the General policy and Procedures for or NEC Enforcement Actions,10 CFF. Part 2, Appendix C.
Norin Jersey Nuclear Diagnostic, Inc.
2 We wish you success in operating a safe and effective licensed program.
Sincerely, John E. Glenn, Ph.D., Chief Nuclear Materials Safety Section A Division'of Radiation Safety and Safeguards Enc '.o s ure s :
1.
License No. 29-28330-01 2.
Recuirements for Katerials Licensees 3.
N:tice for Medical Radiation Safety Officers 4.
hE: Forms 3 and 313 5.
10 CFR Parts 2, 19, 20, 35, and 170 6.
Regulatory Guides 10.8 7.
NRC Fore 473 - Diagnostic Misadministration Report 8.
Caution - Limitations of Use
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- CES MATERIALS LICENSE i
, Pursuant to the Atomic Energy Act of 1954. as amended. the Energy Reorgamration Act of 197 Coot of Federal Regulatiora. Chapter 1. Parts 30,31. 32. 33. 34. 35,40 and 70. and in rehance heretofore made by the hcensee, a Lcense is hereby issued authontmg the hcenset to rece orbver or transfer such matena! to persons autnonted to receive u
l bcense sta!! be deemed to contam the condnions specified m Section 183 of the Atomic Energ
. This l subject to a3 apehcable rules, regulations and orders of the Nuclear Regulatory Commissio conditions spec 2fied below j
1 DCenser l
- 3. North Jersey Nuclear Diagnostic Inc.
3 beense number 29-28330-01 4
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1031 McBride Avenue West Paterson, New Jersey 07424
- 4. Expiration date March 31,1994 l
l 5 D 'h' 030-30943 Reference N.o e By proca:. source and 'or sp
- 7. Chemical and/or physical
- 8. Maximum amount that hcensee special nucleaf matenal form rnay possess at any one time j
soder th2s hcense i
A. Any byprc<uct inaterial A. Any byproduct material A. Total possession limits authorized under paragraphs (including sealed sources) not to exceed individual j
35.57(a), (b), (c) and (d) identified in para h;.
of 10 CFR Part 35.
35.57(a), (b), (c) graphs amounts as specified_in or (d) in paragraphs 35.57(a),
jg of 10 CFR Part 35, that (b), (c) and (d) of has been manufacturea, 10 CFR Part 35.
i labelled, packaged and Y
distributed in accordance M
with the requirerr.ents of 10 CFR 35.49(a).
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Autt ori:ed use
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Non-human use.
For calibrations and checking of instruments.
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10.
Location of use:
1031 McBride Avenue, West Paterson, New Jersey 07424 t
11.
Radiation Safety Officer:
David E. Cohen, M.P.
fe 12.
Authorized User (s):
Material and Use(s):
Davio E. Cohen, M.D.
Lastrence Weinstein, M.D.
Reference sources including sealed sources Michael Green M.D.
Eeference sources including sealed sources y
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Authur Siegel, M.D.
Reference scurces including sealed sources
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Glenn Ross, M.D.
Reference sources including sealed sources Surekha D. thedekar Reference sources including sealed sources
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Reference sources including sealed sources
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MATERIALS LICENSE 29-28330-01 i
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'f SUPPLEMENTARY SHEET 030-30943 g
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CONDITIONS k
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Licensed material shall not be used in or on human beings.
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14 This license is based on the licensee's statements and representations listed F
I' below:
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Application dated December 21, 1988 I
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Letter dated January 27, 1969 a
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1 CAUITCN THIS LICDGE OTLY PEFMITS DE ihuaSIOf MO USE OF C71IEATIOT MO REF SCL~RCES AS SPECIFIED D1 10 CFR 35.57.
)O i<-90i CR USE OF DIN 20STIC CR THEPAPILCIC FADICACITVE FAURIAL FCR PATIDC STUDIES CR 1REAINDE IS A IZED !!
D; ORDER 1D EE AL'IWJRIZED TO WW MO USE DDGOSTIC CR THERAPHCIC RADIO-ACI2VE FAM. YQJ PUST FULTILL DE FDIICh'DC REUIRDOCS:
1.
TAKE DELIVERY OF MO TEST ALL Muw SAFETY KUIMDC, DiCIUDDD DOSE CALIBRAIUR(S) AND RADIATIOi/CINIAMINA22CN SURVEY KUIEDTI.
2.
CD'PEIE MO DETIIUIE ALL REQUIRED RADIATIQi SAFEIY FROCEDURES.
3.
CN TPAINDC OF TECHNICAL AND M3*TTIARY SIATF AS sm.:uu.D Di SEC-TION 19.12 OF 10 CFR PART 19 MO Di I2EM 8 OF YOUR APPLICATIOf.
4.
HAVE YCUR PADIATICN SAFEIY OFFICER tucuY 70 DCT OFFICE DRT 'IH CUDDEFIS HAVE IEEN MET AND URT YOUR NOCEAR htfG DNE PROGRA TO RECEIVE MC USE RADIQACITVE MAIERIAL IN ACCORDANCE WrIH MOTIS OF DE NRC'S RIGJIATIOG AND YOCR LICDEE.
LTON PCTITFICATICN URT YCUR PROGRAM IS READ? FOR NOCIDR MEDICDE OPERAT AND AFTER APFF0FRIATI REVIB1 AND VERIFICATICN, DE NRC WILL ISSUE Mi MENQ4E2C
'IO YCUR LICDEE AUDORIZDC DE USE OF DE RADIOPHARMACDRICAI.S YC FOR PATIDIT SIUDIES OR TREAIMDC.
TME UGUDORIZID USE OF RADIOACTIVE MATERIAL CR DE FAIIIRE TO FOS RADICACITVE PA7ERIAL IN ACCDRDANCE WITH NPC PlIK"ATIOC, 'DE CCiCITIOG OF YCUR LICDISE OR THE le.rmufIATIOE IN YOUR APFLICATICN PRY RESULT IN PCGITICN OF SANCI2OG, INCIUDDC KtEIARY CIVIL PDRLTH5 AND DE 7SSUANCE OF ORDERS SUSPDODO OR RDOKDC YCUR PRIVTTn7 'ID FQ55uss MO USE RADIC VATERIAL.
1 I
l MEDICAL LICENSEE READINESS VERIFICATION CNECKLIST Licensee:
Docket Number:
License Number:
Describe licensee training of techs:
duration:
Describe licensee training of other staff:
duration:
Has the radiation safety officer reviewed the program and procedures and concurrred that it is completely ready for the commencement of licensed activities?
Describe RSD's role in program:
Date dosimet y received:
Supplier:
VP.cle Bocy?
Extremity?
Exchange frequency?
Check source for measurement instrument?
Measured at calibration?
Check source for detection instrument?
Measured at calibration?
Cescribe equipment for wipe sample analysis:
Describe available radiation safety equipment (gloves, lab coa'ts, tongs, ~etc.)
I Check sources for dose calibrator j
lsotope Activity Manufacturer Model l
Date dose calibrator delivered:
Date of dose calibrator accuracy test:
Results:
Date of dose calibrator linearity test:
Results:
' of dose calibrator geometry test:
Resul_ts:
Date of dose calibrator constancy test:
Results:
Reviewer Date i
- ~
4 NOTICE TO MEDICAL RADIATION SAFETY OFFICERS The duties of the Radiation Safety Officer are detailed in Section 35.21 of Paet 35 of Title 10, Code of Federal Regulations.
These duties include responsibility for the establishment, collection and implementation of written policies and procedures, presenting yearly management briefings, reviewing records and personally signing specified records.
You should immediately assure that you are aware of the requirements in both the NRC regulations and in the procedures you have established and submitted to the NRC for review as part of the license application.
The NRC expects that you will be the primary person responsible for safe use of radioactive materials at your facility and will assure compliance with our regulations.
Te aid you in the perform 4nce of your duties, we have highlighted some of the changes which occurred in part 35 when it was totally revised on April 1,1987.
1.
The rules in Part 35 m:y conflict with a licensee's currently approved radiation safety program.
If the license was approved by the Commission before April 1,198'/ and has not been renewed since April 1,1987, the license requirements may take precedence, as provided in 10 CFR 35.999.
i 2.
Ministerial changes, that is, minor changes in radiation safety procedures that are not important to safety, are limited to the changes detailed in 10 CFR 35.31 and to the adoption, by your organization, of NRC Regulations or NRC Regulatory Guide model radiation safety procedures.
Changes other than these will require license amendment.
[35.31]
3.
All licensees, irrespective of license issue date, are authorized to make minor changes in their radiation safety procedures, provided the admin-istrative review and record keeping requirements of 10 CFR 35.31(b) are All ministerial changes must comply with this section.
[35.31(b)]
met.
4.
The diagnostic misadministration form has been issued as NRC Form 473.
In the abstract section of this form, please include your calculated organ and/or whole body dose estimations.
[35.33(c)]
5.
In the event a diagnostic misadministration involves radiation to the wrong patient, the controlling factor for NRC notification is "... an organ dose greater than 2 rem or a whole body dose greater than 500 millirem."
[35.33(c)]
6.
Regardless of whether a misadministration requires NRC notification, records must be prepared for all misadministrations and retained by the licensee for NRC review.
[35.33(d)]
7.
All medical uses involving imaging and localization, radiopharmaceuticals for therapy, and brachytherapy require possession of a detection survey instrument capable of detecting dose rates from 0.1 millirem per hour to 100 millirem per hour and a portable radiation measurement survey instrument capable of measuring dose rates from 1 millirem per hour to
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1000 millirem per hour.
One instrument may satisfy both requirements if the instrument has scales from 0.1 to 1000 millirem per hour and the instrument can be shown to be energy independent over the entire range of energies encountered or if correction factors are available to compensate for the energy dependence.
[35.220,35.320,35.420]
8.
A dedicated check source must accompany survey instruments at the time of calibration and must be used to check the survey instrument for proper operation each day of use.
[35.51]
9.
The permissible molybdenum-99 concentration is 0.15 microcurie of molybdenum-99 per millicurie of technetium-99m.
[35.204]
The Part 35 revisions have consolidated all the essential radiation safety requirements that were previously contained in regulations, license e
conditions, regulatory guides and staf f positions. All new and renewal licenses issued af ter April 1,1987, require that licensed material activities be conducted in accordance with the revised Part 35 regulations.
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