ML20073D409

NMSS Licensee Newsletter.Number 94-2

ML20073D409
Person / Time
Issue date:	06/30/1994
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N94-2, NUREG-BR-117, NUREG-BR-117-N94-2, NUDOCS 9409270193
Download: ML20073D409 (15)

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1. ? w U.S. Nuclear Office of Nuclear NUREGlBR-0117 I

I Regulatory Material Safety No.94-2 Commission and Safeguards Jun. '94/Aug. '94 o

OSP DIRECTOR BANGART PRESENTS AGREE-conducted in accordance with NRC's May 1992 Policy MENT STATES PROGRAM MODIFICA'llONS TO Statement. The Commission has requested that an evalu-CONFERENCE OF RADIATION CONTROL ation of the results of the pilot program be submitted to it PROGRAM DIRECTORS (CRCPD) in November of thisyear..

)

Dese are excerpts of remarks by Richard Bangart, L)irec-He second major initiative is the development of a new tor, Office of State Programs, NRC policy for the determination of Agreement State program adequacy and compatibility. Under the draft new policy

..As many of you know, the U.S. Nuclear Regulatory that is currently receiving Commission review...an Agree-Commission is modifying its Agreement States program, ment State program would be adequate ifit [were to] con-and those modifications will unavoidably affect the tain all those regulations and other program ele-Agreement States, as well..

ments...necessary to assure the health and safety of the

..I [am going to] discuss these program changes and im-public. Using this draft, the Agreement States would i

provements, their status, and most importantly, the goals have the flexibility to establish more stringent require-and objectives that we should be striving toward as we im-ments for those regulations and program elements that plement our respective programs.

are necessary for an adequate program. He draft new policy defines compatibility in terms of those regulations, As I see it, NRC has three major initiatives underway.

and program elements, that should be essentially identi-The first is to develop a common approach for the evalua.

cal, among NRC and all Agreement State programs, be-tion of the performance of NRC regional offices and cause of the need to have a viable national radiation pro-Agreement States that implement the Atomic Energy Act tection program. [The policy has now been issued for materials program. The second is the development of a comment (59 FR 37269, July 21,1994)]....As you are l

new policy for Agreement State program adequacy and aware, we plan to conduct a public meeting during the compatibility. The third initiative includes other ele.

comment period, incorporate the written comments and ments of NRC's Agreement States program that are can.

comments from the meeting into a final new policy, and didates for improvement.

publish the new policy later this year or next year..

..[First), the Commission has directed the staff to imple-The third initiative actually addresses a number of areas ment a pilot program, using common performance indica-that are candidates for NRC Agreement States program tors, where appropriate, and other noncommon perform-improvements. The Commission requested the NRC ance indicators, to evaluate the materials program staff to evaluate candidates forimprovement, and report implementation in both NRC regional offices and Agree-back to the Commission, with recommendations. Among ment States. The pilot program includes NRC Regions I others, these candidat es include Ihe need for additional or and II and the Agreement States of Utah, Illinois, and revised Agreement State program policy statements, the New llampshire, which volunteered to participate in the need to establish requirements for Agreement States to pilot [ program]....For Agreement States, the official pro-report certain information to NRC, an evaluation of the gram review findings will be based on the current program present practice of placing Agreement State-approved review procedures. In the pilot [ program]. those official devices on the NRC registry, an evaluation of the effec-findings will be compared, for program development pur-tiveness of current procedures for handling reciprocity, poses, with the findings that would result from the use of and the need for codification of the Agreement State pro-the common performance indicators....At this point, we gram in a new part of NRC regulations. The NRC staff have completed the reviews in NRC Regions I and II, and has completed the draft of a new umbrella policy state-they appear to have adequate programs under the new ment, for the Agreement States program, that will soon common performance indicator review criteria....On bal-be provided to you for comment, after the Commission j

ance, the new NRC regional review procedure has re-completes its review. The draft policy statement defines ceived a very favorable reaction from the two NRC re-the roles and responsibilities of NRC and the Agreement gions. It's not unfair to characterize the new NRC States and recommends new approaches that include a regional materials program evaluations as being similar to phased implementation period for new Agreement State l

the Agreement State program reviews that have been programs; recommends that program review findings be l

9409270193 940630 l

PDR NUREG BR -0117 R PDR

NMSS LICENSEE NEWSLETTER -

12. A Sampling of Significant Events JUNE - AUGUST 1994 Reported to NRC by NRC Nuclear Material Licensees (Contact:

1.

OSP Director Bangart Presents Agreement Bob Prato, 301-492-4498).................. 9 States Program Modifications to Conference categorized as adequate, marginally adequate, or inade-of Radiation Control Program Directors quate, thus abandoning the much-criticized use of with-(CRCPD)(Contact: Richard Bangart, holding of findings; and for Agreement State programs 301-504-3340)........................... I with serious deficiencies, recommends establishing a pro-bationary status category, with notification to the Gover-2.

Division of Waste Management nor of the State; and setting a time limit forimplementing Organization Addendum program improvements. And finally, the draft policy (Contact: Mike Weber, 301-415-7298)....... 2 statement calls for excellence, both in NRC and Agree-ment State materials programs....The goal expressed 3.

The Advisory Co.mmittee on Medical Uses through 'he excellence objective is to establish, among of Isotopes (Contact: 'Ibrre 'Paylor, NRC an J the Agreement States, a coherent, consistent, 301 -504-1062)............................ 2 and er dible national program for the regulation of Atom-ic Energy Act radioactive materials.

4.

Proposed Amendments to 10 CFR Parts 20 and 35 on Criteria for the Release of Ibtients There are a number of other important initiatives, that Admi tistered Radioactive Material NRC is addressing, that time does not allow me to de-(Contact: Patricia Holahan, 301-415-7847).... 3 scribe now...lrhese include establishing an E-Mail com-munications capability, with States, using INTERNET; 5.

Medical Ouality Management (QM) Notes which is now. functional, and can be used for electronic (Contact: Sally Merchant, 301--415-.7874)..... 3 communications between the States and NRC; establish-ing a national AEA events data base; and evaluating the 6.

NRC Responds to Frequently Asked possibilityof an Agreement StatesFederal AdvisoryCom-Questions about LLW Storage, mittee, to provide earlier substantive input from the Part HI (Contact: James Kennedy, States on NRC regulations, programs, and policies. As we 301-415-6668)..

..................... 4 continue to work to revise NRC's Agreement States pro-gram, I invit e your individual and collective support, com-7.

NRC Approves an Amendment to ments, or critici.uns, as appropriate...

Distribute TLD Readers and Dosimeter Calibrators, Containing Low-Activity DIVISION OF WASTE MANAGEMENT Sources, to Persons Exempt from Licensing ORGANIZATION ADDENDUM (Contact: Joseph Wang. 301-415-7909)........ 5 The March /May edition of the newsletter inadvertently 8.

Rules Published (March 30-June 15,1994) omLted mention of the Low-Level Waste and Regulatory (Contact: Paul Goldberg, Issues Section in the description of the new organization 301-415-7842)

.. 5 for the Division of Waste Management. As part of the Low-Level Waste and Decommissioning Projects Branch, 9.

F.egulatory Guides Issued (March 31,1994, the section is responsible for low-level waste manage-to June 23,1994)(Contact:

ment, decommissioning issues, and interface with the Ibul Goldberg. 301-415-7842).......

6 U.S. Environmental Protection Agency and U.S. Depart-IL

. The section is headed by Michael Weber

10. Information Notices, Bulletins, and k5 Administrative Letters Issued (March 18 -

August 2,1994)(Contact:

Tile ADVISORY COMMTITEE ON MEDICAL lbul Goldberg. 301-415-7842)............. 6 USES OF ISOTOPES

11. A Sampling of Significant Enforcement The U.S. Nuclear Regulatory Commission's Advisory Actions against Material Licensees (Contact:

Committee on Medical Uses of Isotopes (ACMUI) held Pat Santiago, 301-504-3055).............. 8 its regularly scheduled semi-annual meeting on May 19 and 20,1994, at the Holiday Inn, Bethesda, Maryland.

Comments and suggestions you may have for infor-Agenda items included: a status report and discussions on mation that is not currently being included, that the peer comments received on the draft NUREG en-might be helpful to licensees, should be sent to:

titled, " Management of Radioactive Material Safety Pro-grams at Medical Facilities"; a status report by the Nation-E. Kraus al Academy of Sciences on the ongoing external review of NMSS Licensce News /ctter Editor NRC's medical use regulatory ;vogram; discussion of Office of Nuclear Material Safety and Safeguards problems involving fractionateo. igh-dose. rate brachy-Two White Flint North, Mail Stop 8-A-23 therapy procedures, including implanted scaled sources U.S. Nuclear Regulatory Commission that become dislodged or move during treatment; discus-Washington, D.C. 20555-0001 sions on inadvertent administrations of byproduct'materi-al to the wrong patient and related patient notification 2

i

1 requirements; a request by the American Osteopathic excluding background or any occupational exposure, to an ibrd of Radiology for recognition in 10 CFR 35.930, individual exposed to the patient, of 5 millisieverts (mSv)

" Training for therapeutic use of radiopharmaceuticals";

(0.5 rem)in a year. In addition, licensees would be re-and a discussion of draft bylaws for the ACMUI. In addi-quired to maintain a record for 3 yea rs and provide written tion, NRC Jtaff provided status reports on the following instructions to the patient on how to maintain doses to rulemaking efforts: the published proposed rule entitled, others as low as is reasonably achievable, if the quan tity of

" Preparation, Transfer, and Use of Byproduct Material radioactive material is likely to result in an annual total for Medical Use";" Release of Ibtients Containing Radio-effective dose equivalent, to an individual exposed to the pharmaceuticals or Permanent Implants"; and "Adminis-patient, that exceeds 1 mSv (0.1 rem) from a single admin-tration of Byproduct Material or Radiation from Hypro-istration. The proposed rule will clarify that the limit on duct Material to Patents Who May Be Pregnant or dose in unrestricted areas under 10 CFR 20.1301(a) does Nursing." Additionally, the staff briefly discussed revision not include dose contributions from patients adminis-of NRC's " Abnormal Occurrence Criteria" for reporting tered radioactive material and released in accordance events to Congress.

with 10 CFR 35.75.

Two new members who represent the specialties of medi-A draft regulatory guide will be published for comment, cal physics and nuclear pharmacy begin their 2-year terms along with the proposed rule. The guide will provide guid-effective J uly l,1994, and several members of the commit-ance on determining the potential doses to an individual tec concluded their terms effective June 10,1994. The likely to receive the highest dose from exposure to the pa-l specialties of the individuals rotating off the committee tient, to establish appropriate activities and dose rates for are nuclear medicine physician, radiation therapy physi-release, to provide guidahce on instructions for patients cist, nuclear medicine technologist, and radiation oncolo-on how to maintain doses to other individuals as low as is i

gist (teletherapy).

reasonably achievable, and to describe recordkeeping re-quirements.

Copics of the transcripts for the meeting are available through the Public Document Room. Additionally, a MEDICAL QUALITY M AN AG EMENT(QM) NOTES closed session was held to discuss the adequacy of training and experience documentation submitted by a physictan As a result of he U.S. Nuclear Regulatory Commission's applicant. Transcripts of this portion of the meeting are participation in several medical quality management i

not releasable to the pubhe, under the privacy act.

(QM) seminars and workshops, NRC has received a num-ber of requests for clarification of the requirements of a The next meeting of the ACMUI will be held during Octo-brachytherapy written directive. The NRC staff has ad-i ber or November 1994, and noticed in the Federa/ Register, dressed the following questions from those meetings.

I Questions about this information or the ACMUI and its In accordance with the definitions in 10 CFR 35.2, a writ-i l

activitics may be directed to 'Ibrre 'Ihylor, NRC, at ten directive for brachytherapy, other than high-dose-rate 301-504-1062.

j remote afterloading brachytherapy, must ccmtain:

PROPOSED AMENDMENTS TO 10 CFR PARTS 20 Before implantation: radioisotope, number of AND 35 ON CRITERIA FOR THE RELEASE OF sources, and source strengths:

PATIENTS ADMINISTERED RADIOACTIVE 4

MATERIAL and j

After implantation, but before completion of The U.S. Nuclear Regulatory Commission is proposing to procedure: radioisotope, treatment site, and to-amend its regulations concerning the criteria for the re-tal source strength and exposure time (or total lease of patients administered radioactive material. A dose):

proposed rulemaking entitled " Criteria for the Release of 1.

What is NRC's definition for the term "implanta-Patients Admimstered Radioactive Material has becen tion?,,

l published in the FederalRegistcr (FR 30724, J une 15,1994) for public comment. 'lhe comment period will expire 75

'Ib NRC, the term " implantation" refers to the inser-days after publication in the Federal Register The pro-tion of the radioactive sources (not the applicators posed rule responds to two petitions for rulemaking, re-nor catheters).

garding the criteria for release of patients administered radioactive material. NRC has prepared a regulatory If, after implantation, but before the comp etion of 2.

l analysis for the proposed amendment. which is available the procedure, the number of sources and/or source l

forinspection at the NRC Public Document Room at 2120 strengths differ from those listed m the first part of I

L Street NW. (Lower Level), Washington, DC.

the written directive, is the licensee in violation?

No. The first part of the written directive describes The new criteria for patient release would be dose-based rather than activity-based and would be consistent with the optimal intended plan to achieve the " target" the recommendations of the International Commission dose. The sectmd part of the written directive de-I on Radiological Protection. Ihc proposed rule would scribes the final prescribed dose. Under certain cir-amend the criteria for release ofpatients admmistered ra-cumstances, they may not match.

dioactive material for medical use, under 10 CFR 35.75, to 3.

For permanent implants, must the licensee complete permit a maximum likely total effective dose equivalent, the first part of the brachytherapy written directive?

3

Before surgery, the authorized user may not know At the same time, States are making limited progress in how many seeds can be used.

developing new disposal facilities, with most new facilities scheduled to begin operating around the end of the de-Yes, both parts of the written directive must be com-cade. 'Ihus, many generators of LLW will have to store pleted. Before implantation, the authorized user onsite for an extended period of time.

writes the maximum number of sources and source strengths that may be used. After implantation, the NRC continues to encourage the development of new dis-total number and strengths (i.e., total source posal capacity by the States and the prompt disposal of strength), radioisotope, and treatment site are docu.

LLW wherever possible, consistent with the goals and ob-jectives of the LLRWPAA and the protection of the pubhc mented, signed, and dated.

health and safety and the environment. NRC expects 4.

Does the authorized user have to sign and date each LLW disposal sites to be sited and developed in a timely part of the two-part written directive?

manner and that stakeholders, including waste generators and Stat es, will continue to take all reasonable steps to en.

Authorized users should follow the same charting sure that LLW disposal capacity is available soon.

practice used m. ordering any treatment or procedure for signing and dating a note in the patient's chart (or N RC staff has previously issued the following guidance on any other appropriate place). For example, if both storage and management of LLW, when disposal is not parts of the written directive are included on the same available:

chart note or on the same sheet of paper, then only 1.

" Extended one signature is needed. If, however, the two parts of the written directive are completed as separate ac.

Interim Storage of Low-Level Radioactive Waste by tions or as stand-alone chart notes, ther. cach should Fuel Cycle and hiaterials Licensees" be signed and dated.

2.

" Alternative 5.

Can a treatment plan serve as the written directive?

Waste hianagement Procedures in Case of Denial Yes, provided it contains all of the requirements of of Access to Low-Level Waste Disposal Sites" the written directive, as listed above, and is signed and dated by an authorized user.

3.

Generic Letter 85-14:

" Commercial If there are specific questions about written directives for Storage at Power Reactors of Low-Level Radioac-brachytherapy, other than high dose rate, or any other as-tive Waste Not Generated by the Utility" pects of medical Qh! programs, please direct them to Sal-ly L hierchant, at 301-415-7874.

4.

Generic Letter 81-38:

" Storage of Low-Level Radioactive Waste at Power Reactors" NRC RESPONDS TO FREQUENTLY ASKED QUESTIONS ABOUT LLW STORAGE, PAIU III

'lhe following are some frequently asked questions about LLW storage, and our answers are provided to assist gen-In the last two editions of the NMSS Licensee News /ctter "E ""

• **"E9 '

the U. S. Nuclear Regulatory Commission has provideci I"

"" D answ crs to frequently asked questions regarding the stor-age of low-level radioactive waste (LLW). This is the third and final installment in this series.

Region 1:

Betsy Ullrich (215) 337-5NO Regi n II:

J hn Potter (404)331-5571 The Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) allow compacts with operating Region Ill:

Loren Hueter (708) 790-5632 LLW disposal sites to deny access to generators in States Region IV:

Jack Whitten (817) 860-8197 and compacts that have not developed disposal capacity of their own. In accordance with this authority, on January 1, NhiSS Office

Contact:

James Kennedy (301)-415-f/(>8 1993, the Rocky hiountain Coinpact closed the Beatty,

1. Can licensees who have been denied access to Nevada, site permanently, and the Northwest Compact restricted access to the Hanford, Washington, LLW dis-disposal sites dispose of LLW by transferring it to a posal facility to generators in the Northwest and Rocky waste broker who does have access to a disposal site?

hiountain Compacts. The Southeast Compact and South The LLRWPAA permits compacts and States with Carolina allowed the Barnwell, South Carolina, site to ac-cept LLW from most States past the January 1,1993, date perating disposal facilitics to deny access, for dispos-set forth in the LLRWPAA, but effective July 1,1994, re.

al, to LLW generators located in States outside the stricted access, to the site, to generators in the Southeast compact. 'Ransfer of the waste out of the State or Compact, only. The result is that generators in 31 States, compact may require authorization from the receiv-plus the District of Columbia and Puerto Rico, no longer ing State or compact. In addition, brokers may want have access to disposal. For these generators, onsite stor-assurance that the State in which a generator is lo-age is usually the only option for managing their LLW, cated will not impede the return of waste to the gen-other than terminating the use oflicensed radioactive ma-erator, if disposal is not available. Licensees should terials.

therefore consult with compact and State LLW 4

____________________________________________ m

personnel for answers to questions that penain to dis-safety features may be required at the start of a new posal of LLW outside of their region.

term, based on experiences with storing LLW and the safety and environmental reviews that accompany re-o

2. What conditions must be met for a waste broker or newal reviews. The revised guidance also recognizes processor to return processed LLW back to the that storing waste in a form suitable for disposal (the original generating licensee?

previous staff position) may not always be possible LLW brokers / processors should be able to return when, for example, the waste acceptance criteria for a waste back to the generator if the following condi-new disposal facility are not established.

tions are satisfied. First, the waste generator must be The four Euidance documents listed earlier in this ar-authorized, in its license, to receive back the waste.

ticle have been consolidated into a single document Conditions in most mat crials licenses will not prohibit that addresses storage and management of LLW return of waste shipped offsite, for treatment, since when disposal is not possible. A number of other LLW to be returned is originally generated by the li-changes have been made that address storage by nu-censee, and its possession is usually authorized by c! car power reactor licensees.

conditions in the generator's license.

NRC APPROVES AN AMENDMENTREQUEST Second, the State or compact in which the waste gen-TO DISTRillUTE TLD READERS AND l

eratoris located must not impede the return of LLW DOSIMETER CALil3RATORS, CONTAINING back to the generator. States and compacts have de-LOW-AC'IWITY SOURCES, TO PERSONS veloped an Interregional Access Agreement for EXEMI'T FROM LICENSING Waste Management, to establish a nationally uniform On June 2,1994, the U.S. Nuclear Regulatory Commis-approach regarding access to treatment / processing sion received a request, from an NRC licensee, to amend facilities. Under the agreement, compacts and unaf-its NRC license, to authorire it to distribute, to persons filiated States agree not to impede the return of LLW exempt from licensing, thermoluminescent dosimeter that originated in their region or State. Most States /

(TLD) readers and dosimeter calibrators containing low-I compacts have signed the Agreement. Licensees activity sources. In its application, the licensee stated that should contact their State or compact LLW officials the two devices (i.e., TLD reader and dosimeter calibra-for additional information and for details on the im-tor) should be considered as products that meet the re-1 plementation of the Agreement.

quirements of 10 CFR 30.15(a)(9), which authorizes mem-bers of the general public to receive ".. ionizing radiation-l Third, the broker's license should authorize the re-measuring instruments containing, for purposes of inter-turn of the waste. Most licenses governing waste pro-nal calibration or standardization, one or more sources of cessor and broker activities normally do not contain byproduct material." Currently, the licensee is distribut-restrictions on to whom the waste processor can send ing the TU) readers and dosimeter calibrators, to general processed waste. Ilowever, some broker / processor licensees, under an NRC license.

licenses may authorize ".. receipt, storage, and pos-

,Ihe TLD reader and the dosimeter calibrator each con-session... of packaged waste... mcident to transfer to licensed waste disposal facih, ties." (Emphasis added.)

tain one source whose activity is less than the exempt quantity set forth in 10 CFR 30.71, Schedule ll; the source In this example, the broker / processor may want t s used for purposes of internal calibration or standardiza-amend its license to ensure the license includes spe-tion. Further, both the RD reader and dosimeter cahbra-cial authorization to ship waste back to LLW genera-tor are used to directly support TLDs and pocket dosime-tors. In general, any materials licensee may transfer ters, respectively, which directly measure ionizing licensed material to another licensee under the provi-radiation. After reviewing the Statements of Consider-sions of 10 CFR 30.41,40.51, and 70.42.

ation for 10 CFR 30.15(a)(9), and based on th e staff's tech-nical evaluation of these products, the staff has deter-o

3. Are any changes ccmtemplated in NRC guidance mined that the TLD reader and dosimeter calibrator can l

on LLW storage?

be found to be " ionizing radiation-measuring instru-NRC is proposing a few changes, to the guidance, ments" covered by 10 CFR 30.15(a)(9). Approval of this based on experience in using it and in responding to amendment request is a deviation from a previous staff i

l questions from licensees as they prepared for LLW position. 'Ihe staff will consider other applications for au-thorizations to distribute similar 'IU) readers and/or do-storage after June 30,1994. The revised guidance will simeter calibrators.

be sent to the Agreement States, for review and com-ment, in August 1994, and later in the year will be RULES PUllLISHED published in the federalRegister, for public comment.

March 31-June 15,1994 The changes are principally designed to better ad-FINAL RULE dress the expected LLW storage needs of NRClicens-

" Uranium Mill Thilings Regulations; Conforming NRC ees in the United States. The 5-year " limit" for LLW Requirements to EPA Standards" storage is clarified by stating that additional 5-year 1.

Published: June 1,1994 terms for storage will be authorized in connection with license renewal, based on the need. Additional 2.

Contact:

Catherine Mattsen,301-415-6264 5

\\

PROPOSED RULES Note that these are only summaries of publications. If one of these publications appears relevant to your licensed op-Withdrawal: " Procedures and Criteria for On-Site Stor-eration and you have not received it, we recommend that age of Low-level Radioactive Waste" you obtain the notice from the NRC contact listed here E

1.

Published: April 22,1994 Inf rmation Notices 2.

Contact:

Robert Nelson,301-415-6697

" List of Approved Spent Fuel Storage Casks: Addition A. " Regulatory Requirements When No Operations (Standardized NUHOMS Horizontal Modular Storage Are Being Performed," IN 94-21, March 18,1994 System)"

'Ibchnical

Contact:

Kevin Ramsey, NMSS (301) 1.

Published June 2,1994 415-7887 2.

Contact:

Gordon Gunderson,301-415-6195

" Criteria for the Release of Patients Administered Radio-This notice reminds licensees that all regulatory require-active Material" ments must be satisfied even if no operations are being performed. A ser ice company licensed to handle and 1.

Published: June 15,1994 t a..wrt radioactive nterials for its customers was cited 2.

Contacts: Stewart Schneider, 301-415-6225; Mr seven.omuons, incleting failure to have an NRC-K.C. Leu,301-415-7864

pproved radiation safety officer and failure of the radi-adon safety commit tee to review activities, because it con-

" Clarification of Decommissioning Funding Require-sios red its license " inactive" and claimed that it was ments" workNg under the license ofits customer. Radiation safe-1.

Published: June 22,1994 ty progcams required by NRC regulations and license con-ditions raust be mamtamed in an active state while the h-2.

Contact:

Carl Feldman,301-415-6194 cense is in effect. A licensee may not suspend regtired REGULATORY GUIDES ISSUED radiation safety programs and then attempt to reestal,lish them later without a license amendment.

March 31,1994 - June 23,1994 B. " Guidance to Hazardous, Radioactive, and Mixed FINAL GUIDES Waste Generators on the Elements of a Waste Mini-mization Program " IN 94-23, March 25,1994

" Nuclear Criticality Safety Training " RG 368 Technical

Contact:

Dominick Orlando, NMSS 1.

Issued: April 1994 (301) 415-6749 2.

Contact:

Charles Nilsen,301-415-6209

.Ihis notice informs licensees subject to regulation under

" Standard Format and Content of a Licensee Physical the Resource Conservation and Recovery Act (RCRA)of Protection Plan for Strategic Special Nuclear Material at the Environmental Protection Agency's (EPA's) interim Fixed Sites (Other than Nuclear Power Plants)," RG 5.52, final guidance to assist hazardous waste generators and Rev. 3 others to comply with the waste minimization certification requirements of RCRA sections 3002(b) and 3005(h). The 1.

Issued: April 1994 guidance is attached to this notice. 'Ihese licensees are 2.

Contact:

Sandra Frattali,301-415-6261 strongly encouraged to contact the appropriate EPA or W

PROPOSED GUIDES vities are subject to the requirements of RCRA sections 3002(b) and 3005(h). Section 3002(b) requires generators

" Establishing Quality Assurance Programs for the Man-of hazardous waste to certify, on their hazardous waste ufacture and Distributior, of Scaled Sources and Devices manifests, that they have a waste minimization program in Containmg Byproduct Material" place to reduce the volume and quantity or toxicity of such 1.

Issued: May 1994 waste to the degree determined by the generator to be economically practicable. Section 3005(h) requires own-2.

Contact:

John Lubinski,301-415-7868 ers and operators of facilities that receive a permit for the

" Release of Patients Administered Radioactive Materi, treatment, storage, or disposal of hazardous waste, on the als" premises where such waste is generated, to make the same certification no less often than annually.

1.

Issued: June 1994 C. NIOSH Respirator User Notices," Inadvertent Sepa-2.

Contact:

Stewart Schneider,301-415-6225 ration of the Mask Mounted Regulator (MMR) from INFORMATION NOTICES, BULLETINS, AND the Facepiece on the Mine Safety Appliances (MSA) i ADMINLS'IRATIVE LETTERS ISSUED Company MMR Self-Contained Breathing Appara-tus (SCBA) and Status Update," IN 94-35, May 16, March 18,1994 - August 2,1994 1994 6

Technical Contacts:

F.

" Accuracy of Information Provided to NitC during D. R. Carter NRR, (301) 504-1848 the Licensing Process," IN 94-47, June 21,1994 J. Roth, NMSS (301) 415-7176 Technical

Contact:

'Ibrre Taylor, NMSS (301) 504-1062 This notice alerts licensees to two recent respirator user notices issued by the National Institute for Occupational

.lhis notice informs licensecs of the importance of submit-Safety and IIcalth (NIOSil). 'lhe two NIOSil notices, ting accurate information during the licensing process.

dated February 23,1994 and March 31,1994, are attached Applications have been submitted to NRC, without speci-to this notice. 'lhe February 23,1994, notice describes fac.

fying the status of construction of the facility, or misstat-tors that can contribute to the separation of mask-ing the status of construction. The nature and status of mounted regulators from SCll A facepieces and lists the the applicant's proposed facility are material matters m NIOSli certification and MSA part and model numbers of determining whether a license to use byproduct material the affected equipment. The March 31,1994, update no-should be issued to an applicant. 'Ihe operational facility tice describes the development of a Neckstrap/ Regulator-ust be s described in the license application. The appli-Retainer Kit by MSA, designed particularly for use at cant must submit a revision, to the application, for any temperatures below 32 degrees Fahrenheit, and its accep-changes made during the bcensmg process, to the facility tance by NIOSH.

location, or design, equipment, or procedures specified m the application.

D. "Results of a Special NRC Inspection at Dresden Nu-clear Power Station Unit 1 (Dresden 1), following a Ilulletin Rupture of Service Water inside Containment," IN 94-38

" Potential Fuel Pool Draindown Caused by inade-Technical Contacts:

quate Maintenance Practices at Dresden Unit 1,"

James McCormick-Ilarger, Rill (708) 829-9872 Ilulletin 94-01, April 14,1994 Richard Dudley, NRR (301) 504-1116 Larry lleil, NMSS (301) 415-7302 Technical Contacts:

Steve Jones, NRR (301) 504-2833 This notice informs holders of license or construction per-Lee Thonus, NRR (717) 948-1161 mits, for power reactors and fuel cycle and materials li-Larry licll, NMSS (301) 504-2171 censees authorized to possess spent fuel, of the results of a special NRC inspection at Dresden 1, after a rupture of This bulletin informs addressces of the results of a special the service water system occurred inside the wntainment.

NRC inspection at Dresden 1, requests that action ad-On January 25, 1994, the licensee discovered approxi-dressecs implement actions described, and requires that mately 200m3 of service water in the basement of the un-action addressecs provio'c written responses relating to heated Unit I containment. Unit I was permanently shut implementation of the requested action. 'this bulletin de-down October 31,1978. The water originated from a rup-tails a number of conditions, related to the spent fuel turc of the sen-ice water system piping inside the contain-pool, found by the inspection team at Dresden, and dis-ment, that had been caused by freeze damage to the sys-cusses the need for programs to properly maintain and op-tem. The licensee investigated further and found that crate spent fuel pools (SFPs) and to monitor leaks, water there was a potential for a portion of the system inside the inventory,waterquality,and radionuclides. It requestsli-containment to fail and result in a partial draindown of the censees to: verify that particular structures and systems i

spent fuel pool (SFP). An NRC special inspection team related to the SFP are operable and adequate; ensure that issued an inspection report that evaluated the circum-systems for essential arca heating and ventilation are ade-stances of the event and the licensee's investigation and quate and appropriately maintained, to preclude poten-found a number of conditions related to the SFP, which tial freezing failures that could cause loss of SFP water in-are detailed in the report. NRC issued llulletin 94-01 ventory; ensure that piping or hoses in or attached to the (summarized after Event F) to request addressecs to act SFP cannot serve as siphon or drainage paths; and ensure on the findings of the inspection team and the licensee in-that operating procedures address conditions and obscr-vestigation. 'Ihis noticeincludes someinformation on the vations that could indicate changes in SFP level and ad-circumstances at D,esden not included in llulletin 94-01, dress appropriate maintenance, calibration, and surveil-lance of available monitoring equipment, including any E. " Identified Problems in Gamma Stereotactic Radio-leak detection systems. 'lhe bulletin requires licensees to surgery," IN 94-39, May 31,1994 submit, within 30 days, a written response indicating whether the addressee will implement the requested ac-Technical

Contact:

James Smith, NMSS (301) 415-7904 tions, and a schedule forimplementation. If thelicensec chooses not to take the requested actions, there should be This notice describes three incidents and a published a description of any proposed alternative course of action, study that raise a number of concerns in gamma stereotac-the schedule, and the safety basis for determining the ac-tic radiosurgery and reminds licensees of the require-ceptability of the planncd alternative course. The bulletin ments, of 10 CFR 35.32, for a wntten Quality Manage-also requires licensecs to submit a report confirming com-ment Program to meet five specific objectives for gamma plction of the requrted actions, within 30 days of their stereotactic radiosurgery.

completion.

7

Administrative Letter An Order Prohibiting Involvement in Certain NRC-Licensed Activities was issued October 27,1993, to the

" Change of t he NRC Operations Center Commercial above individual. The order was based on the individual Telephone and Facsimile Numbers," No. 94-04, April deliberately failing to wear an alarm ratenieter, failing to 11,1994, post boundaries, and failing to perform radiation surveys of the expowre device and gt.ide tube durit.g the perform-Technical

Contact:

ance of radiographic operations of July 1,1992. De order Jean Trefethen, AEOD (301) 415-6420 prohibits the individual, for a period of 2 years, from per.

With the move of the NRC Operations Center to theTwo forming, supervising, or engag:ng, in any way, in licensed White Flint North (IWFN) building, the primary 24-hour activities under an NRC heense, or an Agreement State telephone number for the NRC Operations Center has

{icense, t hen activitics under that license are conducted in areas of NRCjun diction. For a period of 2 years after s

changed from (301) 951-0550 to (301) 816-5100. He backup numbers have changed from (301) 427-4056, the prohibition, the mdisidual shall be required to notify 427-4259,492-8893,951.-6000, and 951-1212, to a single NRC of his employment by any person engaged in lp number-(301)951-0550(which was the previous primary censed actisitics under an NRC or Agreement State h-telephone number). He facsimile number has changed cense, w that appropriate inspections can be performed.

from (301) 492-8187 to (301) 816-5151. This change oc.

Dun,ng that same penod, the mdisidual shall also be re-curred at the end of hiay. After this date, both numbers quired to provide a copy of the order to any person em-reach the new center, for no less than 90 days. After this pl ying hu, n and who holds an NRC bcense or an Agree-time, only the new phone number will reach the Opera-ment State license and performs licensed activitics in an tions Center.

NRC junsdiction.

IL Civil Penalties and Orders / Notices of Violations Notice 1.

Department of the Army, Rock Island, Illinois

" Final Revisions to 10 CFR Parts 170 and 171 on Li-Supplement VI, EA 93-272 cense Inspection, and Annual Fees for FY 1994,"

July 18,1994.

A Notice of Violation and Proposed imposition of Civil Penalty was issued Dec;mber 28,1993, to His notice advises applicants; reactor vendors; and hold-emphasize the nesd for effective management ers of licenses, Certificates of Compliance, registrations oversight of NRC licensed activities. He action of scaled sources and devices, and approvals of quality as-was based on a breakdown in control of licensed surance programs, of the issuance of new fee require-activities involving: the possession and use of tri-ments, which are detailed in a Federal Register notice, a tium in fire control devices and the possession copy of which is attached to the notice.

and use of americium-241 in chemical agent de-tectors.

A SAhiPLING OF SIGNIFICANT ENFORCEhiENT ACllONS AGAINST hiATERIAL LICENSEES 2.

Yale-New IIaven Hospital, New Haven, Connec-ticut, Supplements IV and VI, EAs92-241 and A. Individual Actions93-016 1.

William K. Headley I A 94-002 A Notice of Violation and Proposed imposition of Civil Penalties was issued April 26,1993,to An Order Requiring Notice to Certain Employ-emphasize the importance of: (1) strictly adher-ers and ProspectiveEmployers and Notification ing to regulatory requirements, so as to ensure to the U.S. Nuclear Regulatory Commission of that licensed activities are conducted safely, and Certain Employment in NRC Licensed Activi-radioactive material is not left unsecured in the ties was issued hiarch 14,1994, to the above indi-public domain; (2) ensuring that corrective ac-vidual. The order was based on the individual's tions taken or planned are long-lasting; and (3) deliberate actions in failing to make daily and ensuring that the Licensce's Quality hianage-weekly radiation surveys in the nuclear medicine ment Program (OhiP) includes written proce-department where he is employed and falsifying dures and policies, to provide high confidence NRC-required records, to make it appear that that administrations of raJiation or radioactive the surveys had, in fact, been performed. De materials to patients are in accordance with the violations continued over a period of approxi-written directive. The action was based on viola-matcly 2 years. The order requires that the indi-tions involving failure of the licensee to: conduct vidual notify NRC, for a period of 2 years if he is surveys, secure radioactive materials, and ensure currently employed or accepts empk>yment in-that radiation areas in unrestricted areas comply volving NRC-licensed activities with any employ-with regulatory limits. In addition, there were er other than the licensee where the violations violations resulting in two patient misadministra-occurred, and that he provide a copy of the order tions. A Confirmatory Order was also issued to to such employers and prospective employers.

require, in part, that the licensee retain an inde-pendent consultant, to assess the program, and 2.

George D. Shepherd IA 93-002 that the licensee implement an improvement 8

plan. He licensee responded June 10,1993, ad-

6. ~ Wayne County Department of Public Services, mitting three of the violations, denying two viola.

Detroit, Michigan, Supplement IV, EA 93-220 tions of the QMP requirements, and requesting mitigation of the civil penalty. After consider-A Notice of Violation and Proposed Imposition ation of the licensee s response, an Order Impos-of Civil Penalties was issued September 27,1994, to emphasize the need to properly control li-mg Civil Monetary Penalties was issued Decem-censed mat erial and to strictly adhere to NRC re-ber 27,1993.

porting and Department of Transportation re-quirements. The action was based on violations 3.

American Tbsting and Inspection, Inc., Country associated with an event on July 7,1993, in which Club Hills, Illinois, EA 92-102 a nucleargauge fell off the back of a truck, and an event on August 16, 1993, in which a nuclear A Modified Confirmatory Order was issued Jan-E""E# *"'

l uary 5,1994, withdrawing the civil penalty, as pro-posed in the Notice dated October 7,1992. Un-7.

Agricultural Research Service, Washington, DC, der the terms of the order, the licensee will:(1)

Supplement IV, EA 94-001 not apply to NRC for a new license until after i

i March 23,1996; (2) only be able to work as an as-A Notice of Violation was issued January 24, l

sistant radiographer; (3) provide notice to the re.

1994, based on a violation involving the proper I

gion before being employed within NRC jurisdic-security and control over licensed radioactive tion; and (4) praide a copy of the Confirmatory material. A moisture / density gauge that con-Order to any employer, holding either an NRC tained 40 millicuries of cesium-137 and eight mil-license or an Agreement State license, perform-licuries of americium-241 was left unattended in 1

ing licensed activities within NRC jurisdiction.

an unrestricted area. The unattended gauge was damaged by a construction vehicle backing into it.

A civil penalty was not proposed because the li-4.

Cooper Hospital / University Medical Center, censee identified the violation and took prompt Camden, New Jersey, Supplements IV and VI, and comprehensive corrective actions.

EA 93-310 A Notice of Violation and Proposed Imposition A SAMPLING OF SIGNIFICANT EVENTS of Civil Penalty was issued February 4,1994, to REPORTED'10 NRC BY NRC NUCLEAR emphasize the importance of aggressive manage-MATERIAL LICENSEES ment oversight of the licensee's radiation safety program, so as to ensure that licensed activities A. NRC LICENSEES are conducted safely and in accordance with re-Event 1:

Medical lirachytherapy Misadministration quirements, and violations, when they exist, are at Hospital Metropolitano in Rio Peidras, promptly identified and corrected. The action Puerto Rico was based on violations mvolving an overexpo-sure of 21.7 rem, to the hand of a nurse, at the Date Reported:

December 11,1993 l

facility, who handled waste materials after the l

administration of phosphorus-32 to patients.

Licensee:

Hospital Metropolitano; Rio Peidras, Puerto Rico j

5.

Nondestructive Inspection Service, Inc., Hurri-On December 9,1993, at 5:20 p.m., a patient began a gyne-cane, West Virgima, Supplement VI, EA 93-205 cological low-dose-rate brachytherapy treatment. The A Notice of Violation and Proposed Imposition patient was prescribed a treatment of 3000 centigray (cGy) of Civil Penalty was issued September 1,1993, to (3000 rad) by a 48-hour exposure to approximately 2.3 gi-emphasize the importance of performing ade-g becquerel (61.3 millicurie [ mci]) of cesium-137 quate surveys during radiographic operations and (Cs-137).

ensuring that ope ational activities are con-On December 11,1993, at approximately 7:30 a.m., (about ducted safely and m accordance with require-10 hours before the end of the prescribed treatment), the ments. He action was based on a vo, lation that patient intervened with the procedure by removing the mvolved the failure to conduct an adequate sur-implant containing three Cs-137 sources of approximately I

vey dunng radiographic operations at a tempo-730 megabecquerel (20.4 mci) each, and placing it next to rary job site. The licensee responded September her thigh. Shortly after removing the implant, the patient 22,1993, and requested that the severity of the showed the device to the floor nurse. The nurse recog-penalty be reconsidered in view of the hcensee's nized the implant and understood the need for concern.

corrective actions, its good prior performarice, She did not take the device from the patient, but reported and the depressed economy. After reviewmg the the situation to her supervisor. The patient apparently re-licensee's response, the NRC staff concluded turned the device next to her thigh beneath the bed linen.

that the civil penalty should be mitigated by 100 percent, based on the licensee's prior perform-At the time of being informed, the nursing supervisor was ance, and a letter to that effect was issued Febru-experiencing difficulty with another patient, and was in-ary 22,1993.

volved in shift turnover. Because of these distractions, 9

L

the supervisor failed to realize the urgent nature of the radiopharmaceutical or scaled source therapy. As a mini-situation and did not make the required notifications.

mum, the procedures will define what is a radiological emergency and will provide examples of situations that On several occasions that morning, other licensee person-must be considered radiological emergencies or that nel entered the patient's room without realizing that the could result in misadministrations, ne licensee also radioactive source was exposed, because it was covered by committed to developing and implementing a retraining bed linen; the patient did not notify any additional staff program, based on the revised emergency procedures for members that she had removed the implant. Approxi-all hospital employees who may be involved in handling mately 2-1/2 hours after the estimated time of the source patients receivmg radiation therapy.

removal, the attending physician attempted to perform a routine check of the implant and discovered that it had Event 2:

Teletherapy Misadministration at Wiangle been removed and placed next to the patient's thigh.

Radiation Oncology Associates in Pitts burgh, Pennsylvania After properly accounting for and storing the sources, the physician examined and inteniewed the patient. Based Date Reported:

December 20,1993 on discussions with the patient and review of the exposure Licensee:

Triangle Radiation Oncology received, the attending physician terminated the treat-Associates, Pittsburgh, ment. This decision was based on the physician's determi-Pennsylvania nation that the treatment received was clinically adequate and his concern that the patient was a threat to herself and On December 20,1993, Triangic Radiation Oncology As-others.

sociates in Beaver, Pennsylvania, notified NRC of two po-tential teletherapy misadministrations that occurred be-The actual dose delivered to the intended treatment site tween December 13 and 17,1993, at the licensee's was calculated to be 2270 cGy (2270 rad). The written di.

Pittsburgh, Pennsylvania, facility. The potential misadmi-rective was revised to reflect the lower dose delivered, nistrations were identified during a review of patient re-De licensee's evaluation of the incident indicated that as-cords, on December 17,1993, when the licensee observed suming the implant remained in the same location for 3 calculation errors involving the depth of the dose given to hours, the maximum dose to the skin of the patient's thigh each of the two patients.

(the wrong treatment site) was 572 cGy (572 rad). The li-censee reported that no adverse effects to the patient are Both cases involved breast cancer treatments, where the

expected, original treatment plan prescribed 28 treatments of 180 centigray (cGy) (180 rad) from a cobalt 60 teletherapy The patient was notified s erbally at the time the misadmi-source (using two parallel opposed fields) for a total ab-nistration was discovered and then notified in writing on sorbed dose of 5040 cGy (5040 rad). The primary breast January 13,1994.

cancer treatments were concluded on December 10,1993.

The physician wrote separate written directives for each The initial cause of the misadministration was the pa-patient to receive an additional 1000 cGy (1000 rad) to the tient's removal of the implant, compounded by the failure scar in five treatments of 200 cGy (200 rad) per day. One of the two nurses to follow emergency procedures. The of the written directives indicated that the absorbed dose nurses' failure to respond to the emergency resulted in was to be delivered at dmax, the maximum extension of approximately 2-1/2 hours of unnecessary exposure.

the' teletherapy unit, which, as stated by the physicist, is typically a depth of 0.5 centimeter (cm)(0.2 inch). The t

The licensee determined that the nursing supervisor *s other written directive did not indicate a depth; however.

l failure to make the required notifications was because of the physician stated that the intended depth was dmax.

the lack of familiarity with established radiation safety procedures in which she had been trained. De licensee's As described above, such a treatment plan would typically investigation of the event revealed that the lack of famil-have been calculated by the teletherapy technologist at iarity with radiation safety procedures was caused by the the Pittsburgh facility and communicated by telephone to irfrequent handling of patients undergoing therapy with the teletherapy physicist at the Beaver facility, to be licensed materials. He licensee held a Radiation Safety checked. However, this procedure changed when the Committee meeting in which the incident and corrective computer at the Pittsburgh facility was taken out of ser-actions to prevent recurrence were discussed.

vice on December 1,1993.

The licensee decided to dedicate one floor of the hospital On December 9,1993, the teletherapy technologist hand-for all therapies involving NRC-licensed materials. This wrote a paraphrased request of the written directive for will provide additional controls to allow the licensee to the two breast-cancer-treatment patients needing scar better ensure that nurses assigned to the floor are kept booster dose calculations. Rather than writing dmax, the current and familiar with operating and emergency proce-technologist stated the tumor dose at a depth of 5 cm (2 in) dures. De licensee is also evaluatins the need to increase and sent the request, via facsimile transmission, to the patient awareness regarding nonintervention in proce-teletherapy physicist at the Beaver facility. Hand calcula-dures.

tions were performed for 200 cGy (200 rad) treatments at i

i a 5-cm (2-in) depth, checked by a certified physicist, and The licensee is revising its procedures for responding to sent back to the technologist, via facsimile transmission, radiological emergencies involving patients undergoing on December 9,1993, 10

.= _

He patients were treated from December 13 to 17,1993, ne licensee conducted an extensive physical search for and received doses of 1300 and 1320 cGy (1300 and 1320 the sources and reviewed all radioactive material permits rad) respectively, rather than the 1000 cGy (1000 rad) issued to other organizations at Brooks AFB. When the intended. This resulted in misadministrations of 30 and 32 disposition of the Sr-90 sealed sources could not be deter-j percent greater than the intended dose. He licensee's mined, the licensee reported the loss of the four sealed i

physician stated that no adverse clinical effects are ex-sources to NRC, by telephone, on September 22,1993.

pected as a result of the overexposures.

The licensee informed NRC that the United States Air Force (USAF) Inspector General would review this inci-After the initial report, the licensee told NRC, in subsc-dent. He licensee suspected that the sources had been quent telephone conversations, that a recalculation of the inadvertently discarded and transported to a sanitary dose averaged over the entire tumor volume did not ex-landfill.

ceed 30 percent and, therefore, the licensee no longer thought the definition of a misadministration applied in ne licensee evaluated possible radiation exposure to this case.

members of the general public and concluded that unless the sources were removed from the container, the radi-NRC performed a sPecial inspection on December 28 and 29,1993, to review the potential misadministrations. In-ation levels from the sources would be near background level. Furthermore, unless a deliberate effort were made formation gathered during this mspection, mcluding the calculations of the admmistered doses, was given to an to open the source capsules, an individual handling the NRC scientific consultant to evaluate. He scientific con-sources would receive less exposure than allowed by regu-latory limits for the general public.

sultant, m his report to NRC, stated that "The dose pre-scription was to dmax (i.e.,0.5-cm [0.2-in] depth on the central axis) and a misadministration can only be j,udged During 1991, the timeframe during which the sources by considering the dose given to this point... clearly, m were apparently lost, a number of individuals were re-m, sponsible for the radiation safety program at Brooks AFD.

both cases, a misadm, istration has taken place. On March 25,1994, the bcensee was m, formed that the doses These individuals were temporary or part-time Radiation to both patients were deemed to be misadministrations.

S.afety Officers (RSOs), and had extensive, temporary du-ties at other sites, He licensee submitted its report of misadministrations in a letter dated April 7,1994.

He results of the USAF Inspector General's investiga-After receiving the scientific consultant's report, an NRC tion determined that " Programmatic issues started to P ague radiation safety at Brooks AFB after the disman-l medical consultant was retained to perform a clinical eval-uation of the patients.

tling of the base / clinic program and the inception of addi-l tional duty RSOs."The report explained that in 1986, the The referring physician was notified and determined that, radiation safety function and responsibility were trans-based on medicaljudgment, informing the patients of the ferred to the base clinic at Brooks AFB. Almost simulta-misadministrations would be harmful, neously, a Joint Military Medical Command (JMMC) was established and the base clinic became a part of the neh.censee implemented a requirement for a stamp to JMMC, The JMMC was a medical command established be placed on all written directives, that prompts a clear to ser ice all branches of the Armed Forces in the San documentation of key treatment parameters such as site, Antonio, Texas, area. With this action, the radiation safe-method, daily dose, fractions, total dose, depth of calcula-ty program was managed by an organization that was not tion, spmal blocks, other blocks, and date. Previously, key responsible to any management level at Brooks AFB.

parameters had been mformally handwritten directives Furthermore, the report stated that the JMMC dis-on patients' treatment charts. He licensee also formal-mantled the clinic's radiation safety program, and "..re-ized its requirement to include the written directive for all quested that all organizations previously under the clinic's dosimetry calculation requests from the Beaver facility, program establish and run their own radiation safety pro-and revised its " weekly chart check" procedure to increase gram." Exacerbating the problem was the appointment of chart reviews from once a week to twice a week, as was the the additional duty RSOs, who had ".. limited-to-general j

practice before December 1,1993.

knowledge of radiation safety," and no directives or other Event 3:

Lost Reference Sources at Brooks Air guidance to assist them. Additionally, "De additional Force Base in San Antonio, Texas duty RSOs received little management oversight after they had been appointed to the RSO position."

Date Reported:

September 22,1993 Licensee:

Armstrong Laboratory, Brooks The investigation concluded that from 1986 through 1991, Air Force Base (AFB), San there had been a lack of commitment to management Antonio, Texas oversight, and a serious disregard for radiation safety is-sues.

As prescribed by the licensees *s Compliance Accountabil-ity and Control Procedures, in 1993, the licensee per-In 1991, Armstrong Laboratory was placed under a new formed an audit of alllicensed sources at Armstrong Lab-Air Force Command. The Command committed to in-oratory. During this audit, the licensee identified four creased management oversight of the radiation safety missing strontium-90 (Sr-90) reference sources of ap-programs. Additionally, physical inventory procedures j

proximately 14.8 megabecquerel (400 microcuric) each.

were revised.

11

On February 11,1994, NRC issued a Notice of Violation The licensee performed thyroid monitoring of the pa-for violations invohing: (1) a failure to secure licensed tient's visitors and hospital employees involved in the care material; and (2) failure to include, in one USAF permit, a of the patient. One of the licensee's employees had re-requirement to conduct a periodic physical inventory of ceived a committed dose equivalent, to the thyroid, of 50 all licensed materials.

microsievert (Sv)(5 millirem [ mrem]). In addition, a visi-tor had received a committed dose equivalent, to the thy-No civil penalty was assessed because of the Air Force's roid, of 540 Sv (54 mrem), or a total effective dose equiva-discovery of this violation and the promptness and com.

lent of 160 Sv (1.6 mrem), which is less than the annual prehensiveness of the corrective actions.

limit, for members of the general public, of 1000 Sy (100 mrem).

Event 4:

hiedical Brachytherapy hiisadministration Through patient monitoring, the licensee estimated that at the University of Cincinnatiin approximately 5 percent of the free I-125 was taken up in Cincinnati, Ohio the patient's thyroid. (In a normally functioning, un-blocked thyroid, approximately 25 percent of the free io-Date Reported:

January 14,1994 dine would have been taken up in an individual's thyroid.)

Licensee:

University of Cincinnati The licensee estimated that the uptake would result in a r diation dose, to the thyroid, of approximately 300 centi-Cincinnati, Ohio gray (300 rad). The licensee did not expect the patient to On January 14,1994, NRC was notified, by telephone, of a suffer any adverse medical effects as a result of the misad-ministration. An NRC medical consultant concluded that misadministration invoMng a leaking iodine-125 (I-125) brachytherapy implant seed. On January 7,1954,16 I-125 the non-radioactive iodinated contrast agent used during seeds, each ranging from 370 to 1110 megabecqueret an imagmg procedure performed on the patient before (hiBq)(10 to 30 millicurie [ mci]) activity, were implanted the implant blocked the absorption of the I-125. He also in the brain of a 30-year-old male patient. After the ex, concluded that exposure to the radiation levels described plant procedure on January 14,1994, the licensee identi-resulted m an increased probability of the patient devel-fied radioactive contamination in the surgical room and opmg thyroid tumor (s)in the future.

bathroom used by the patient. Personnel from the licens-For future procedures, the licensee plans to ensure that ce's radiation safety office identified the contamination '

the implanted seeds are located farther down the cathe-be I-125 and confirmed that at least one seed was leaking.

ter, to reduce the likelihood of seed damage from surgical Further licensee analysts determined that one seed was staples. The licensee also plans to examine each I-125 damaged, during the implant procedure, by a surgical sta-seed for leakage, after each explant procedure.

ple. The seed origmally contamed 758 hiBq (20.5 mci) of I-125 and, based on an assay of the explanted source, the The patient has been contacted several times for follow-licensee estimated that the loss was approximately 74 up observations; however, the patient lives out of town hiBq (2.0 mci).

and has not been willing to cooperate.

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