ML20082B731

NMSS Licensee Newsletter.Number 95-1

ML20082B731
Person / Time
Issue date:	04/30/1995
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N95-1, NUREG-BR-117, NUREG-BR-117-N95-1, NUDOCS 9504050305
Download: ML20082B731 (12)

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s U.S. Nuclear Office of Nuclear NUREGlBR-0117 I

J Regulatory Material Safety No.95-1

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Commission and Safeguards Mar. '95/Apr. '95 o

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a DR. SELIN TO LEAVE NRC business with my son. We're going to explore the possibility of building non-nuclear power plants in Dr. Ivan Selin, Chairman of the U.S. Nuclear Asia where the demand for energy is enormous, Regulatory Commission, issued the following as a number of countries strive to improve the statement on March 14, 1995:

quality of life for their citizens. Note that I said non-nuclear, such as gas-fired or coal-fired I have informed the White House of my intention generating plants. Given what I have been doing to leave the Nuclear Regulatory Commission as of for the last 4 years, I don't think it would be July 1,4 years after I took office as Chairman. I appropriate to be involved in nuclear power, even do this with mixed feelings because I have enjoyed though nuclear power will be part of the national l

immensely the challenges of this job. But even if energy mix in any number of places.

I the Commission is left temporarily without a J

quorum, thanks to steps we took last summer to Please indulge me for a moment while I underline, put m place a contm, gency plan, the remaimng briefly, some of the major accomplishments over Commissioners will be able to operate with the the past 4 years here:

full authority of the Commission until a quorum is restored.

continued improvement in the safety of e

I have spent the last 6 years of my life in my Perating reactors; second tour in government-as Under Secretary increased openness in the way that the of State and as Chairman of this agency. These e

have been exciting years, years in which I have Commission conducts its business; been proud to serve and proud to be associated with many solid accomplishments. The last 4 a one-step process for approving new reactor e

years have been particularly eventful, significant designs and licensing new reactors; ones in the life of NRC. We have accomplished 4

much in adapting our rules, regulations, and renewal of existing reactor licenses; and I

e procedures to the changes in the world of energy, I

while never wavering from our primary mission of protectmg the health and safety of the Amen,can simplification and reduction of a variety of l

e people.

regulations.

In these 4 years we have also witnessed a revolu.

All but the last of these were objectives I raised as tion in the world of international nuclear power.

my priorities in my confirmation hearings 4 years Previously isolated nuclear power programs-in ago, and all have been accomplished while we the former Soviet Union, Eastern Europe, East reduced the NRC budget by 3 percent a year in and South Asia, and South Africa-have joined real terms.

the world nuclear community, while newer pro-grams in East Asia have taken off. I am proud My successors will have plenty more to do. They of the role that NRC has played in meeting the will have to carry through on these programs, challenges of this unexpected international further streamline the regulatory process, and development, and increasing the safety of these continue to reduce the costs of the agency.They programs.

will also have to see through the licensing of facilities for spent fuel and should get NRC out of Now it's time to move on. My intention is to the business of regulating the medical use of return to the private sector, to start a new radioactive materials.

9504050305 940430 PDR NUREG BR-0117 R PDR

NMSS LICENSEE NEWSLETTER -

13. A Sampling of Significant Events

^

MARCH - APRIL 1995 Reported to NRC by NRC Nuclear Material Licensees (Contact: Robert Prato, AEOD, 301-415-6343)........... 10 Page NRC is a small but distinguished agency, with 1.

Dr. Selin to Leave NRC................. 1 about 3000 highly skilled, dedicated people and a budget of slightly more than $500 million. The Agency's principal task is to regulate 108 nuclear

2. ManaEement Chan8es in NMSS (Contact:

power plants that supply more than 20 percent of George Deegan, NMSS, 301-415-7834).... 2 the country's electricity. Although new plants are not being built today, existing facilities will still be

3. Proposed Rule on Medical Administrations producing electricity at the current high levels for to the Wrong Individual (Contact: Sally at least 20 more years, making an important contribution to the wealth of the nation. Nuclear Merchant, NMSS, 301-415-7874)......... 3 power in the United States is among the safed in the world; a vigilant, independent regulator is 1

4. Proposed Rule on Decommissioning required to ensure it stays that way.

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Financial Assurance (Contacts:

Dr. Carl Feldman, RES,301-415-6194; I feel good about the contributions the Agency Mary Thomas, RES, 301-415-6230)...... 4 has made, with your help; I am confident it will continue to be an agency of which you can be very Proud.

5. Isotopic Analysis Important to Site MANAGEMENT CHANGES IN NMSS Orland iS 1

5 4).........4 A January 20,1995, announcement to all U.S.

6. Assay of Pure Beta Emitters (Contact:

Nuclear Regulatory Commission employees

'Ibrre Taylor, NMSS, 301-504-2434)...... 5 reported the following management changes:

Mr. Guy A. Arlotto, Deputy Director, Office e

7.

Semi Annual Meet.ing of the of Nuclear Material Safety and Safeguards Advisory Committee on Medical Uses (NMSS), indicated his intention to retire on of Isotopes (Contact: Tbrre 'Paylor, February 3,1995, after 33 years of service with NMSS, 301-504-2434).................

5 NRC and its predecessor, the Atomic Energy Commission.

8. Availability of Report on Safety Dr. Carl J. Paperiello, Director, Division of e

Programs at Medical Facilities (Contact:

Industrial and Medical Nuclear Safety Janet Schlueter, NMSS,301-415-7894)...

5 (IMNS), NMSS, was selected to succeed Mr. Arlotto. (See second announcement for

9. Quality Management (OM) Notes new phone number.)

(Contact: Sally Merchant, NMSS, 301-415-7874)...................... 5 Comments, and suggestions you may have for

10. Generic Communications Issued informatio-that is not currently being (Overall

Contact:

Kevin Ramsey, included, that might be helpful to licensees, NMSS, 301-415-7887)....

.. 6 should be sent to:

E. Kraus NMSS Licensee Newsletter Editor

11. Federal Register Notices (Overall

Contact:

Kevin Ramsey, NMSS,301-415-7887).... 7 Office of Nuclear Material Safety and Safeguards ho White Flint North, Mail Stop 8-A-23

12. A Sampling of Significant Enforcement U.S. Nuclear Regulatory Commission Actions against Material Licensees (Con-Washington, D.C. 20555-0001 tact: Pat Santiago. OE,301-415-3055)...

8 i

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o Dr. Donald A. Cool, Chief, Radiation Protec-missioning Projects Branch. Mr. Weber's new tion and Health Effects Branch, Office of phone number is 301-415-7297.

Nuclear Regulatory Research (RES), was selected to replace Dr. Paperiello as IMNS Larry W. Camper, formerly a section leader in e

Division Director. Dr. Cool's new phone the Medical, Academic, and Commercial Uses number is 301-415-7197.

Branch in NMSS, was appointed Chief of the Medical, Academic, and Commercial Uses Dr. John E. Glenn, Chief, Medical, Academic, Branch. Mr. Camper's new phone number is e

and Commercial Use Safety Branch, in IMNS, 301-415-7231.

was selected to replace Dr. Cool in his former position in RES. Dr. Glenn's new phone PROPOSED RULE ON MEDICAL number is 301-415-6157.

ADMINISTRATIONS TO THE WRONG INDIVIDUAL On March 1,1995, a second announcement reported the following additional management On January 25,1995, a proposed rule was pub-changes:

lished in the Fedeml Register (60 FR 4872) to clarify that the medical administration of radia-o Robert M. Bernero, Director, NMSS, tion or radioactive materials to any individual, indicated his desire to retire on April 28,1995, including an individual who is not supposed to after a long and distinguished career in NRC receive a medical administration, is regulated by and its predecessor, the Atomic Energy the U.S. Nuclear Regulatory Commission's pro-Commission.

visions governing the medical use of byproduct material (10 CFR Part 35) rather than the dose o Dr. Carl J. Paperiello, formerly Deputy limits in NRC's regulations concerning standards Director of NMSS, was appointed Director-for protection against radiation (10 CFR Part 20).

designate. Dr. Paperiello's new phone number is 301-415-7800.

This proposed rulemaking resulted from a specific j

case where there was an error in the administra-o Dr. Malcolm R. Knapp, formerly Director of tion of a diagnostic radiopharmaceutical to a the Division of Waste Management in NMSS, patient who was not supposed to receive any 4

was appointed Deputy Director of NMSS.

radioactive material. The Commission directed Dr. Knapp's new phone number is the staff to proceed with rulemaking to clarify 301-415-7358.

that the medical administration of radioactive material to a patient (which includes a " wrong o John T. Greeves, formerly Deputy Director of patient")is the exclusive province of the regula-the Division of Waste Management in NMSS, tions in Part 35. This is not a change in policy, but was appointed Director, Division of Waste rather, clarifies that the more specific require.

Management. Mr. Greeves' new phone num-ments in Part 35 prevail over the more general ber is 301-415-7437.

requirements of Part 20.

o Margaret V. Federline, formerly Chief of the Until such time as the rulemaking is completed, Performance Assessment and Hydrology NRC will exercise enforcement discretion and not Branch in NMSS, was appointed Deputy cite licensees for violations of 10 CFR 20.1301 in Director of the Division of Waste Manage-cases involving the medical administration of ment. Mrs. Federline's new phone number is byproduct material or radiation from byproduct 301-415-6708.

materialif the total effective dose equivalent to the patient exceeds the limits for a member of the o Dr. John II. Austin, formerly Chief of the general public (1 millisievert (100 mrem)). but Low-Level Waste and Decommissioning does not exceed the threshold for reporting as a Projects Branch in NMSS, was appointed misadministration in Part 35. However, licensees Chief of the Performance Assessment and are reminded that an administration of byproduct flydrology Branch. Dr. Austin's new phone material, or radiation from byproduct material, to number is 301-415-7252.

the wrong patient, that exceeds the thresholds specified in 10 CFR 35.2, will continue to be o Michael E Weber, formerly a section leader in classified as a misadministration.

the Low-Level Waste and Decommissioning Projects Branch in NMSS, was appointed The comment period for this proposed rule-Chief of the Low-Level Waste and Decom-making expires on April 10.1995.

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PROPOSED RULE ON DECOMMISSIONING wish to cease nuclear operations and close their l

l FINANCIAL ASSURANCE facilitics. De complcte and accurate character-ization of the radiological status of a facility is On June 22,1994, a proposed rule on Decommis-critical to the timely and cost-effective completion sioning Financial Assurance was published in the of the decommissioning. Recent experience char-Fedemi Register for comment (59 FR 32138). The acterizing offsite contamination near a site in comment period ended September 20,1994. Six Cambridge, Ohio, highlights the potential impor-letters were received. The proposed rule tance of conducting a complete isotopic analysis addressed concerns that a number of licensees of environmental samples for radiological con-have not put aside adequate funding for decom-taminants, using both gamma and alpha spec-missioning. These cases involved licensees who trometric techniques, to ensure that delays in the were in timely renewal when the rule became decommissioning process are avoided.

effective and have not yet provided adequate funding, or have decided to cease operations and NRC Region llI and Headquarters staff recently begin decommissioning without adequate funding discovered offsite contamination near an NRC in place. The proposed rule was intended to bcensed facility m Cambridge, Ohio, that con-clarify that financial assurance must be in place tained elevated concentrations of Th-230, Pa-231, during operations and updated when a licensee and Ac-227.The activitics of these radionuclides

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decides to cease operations and begin decommis-were in gross disequilibr,um with parent radio-i sioning. In particular, the proposed amendments nuclides m the 'U-238 and U 235 decay chams.

would explicitly describe additional financial assurance certification requircicents for licensees Although field exposure rate surveys mdicated during operation, as well as implementation and nly slightly elevated radiation levels, laboratory timing requirements for licensees whose licenses ana!ysis of the soil sample yielded high concen-s trations of Th-230 (one sample exhibited Th-230 have been in timely renewal since the promulga, concentrations m excess of 4000 pCi/g). Such high tion of the 1988 decommissioning funding rules or concentrations were not expected because con-who cease operations without adequate funding tammation was only expected to m, elude relatively arrangements in place. Presently, the final rule is I w concentrations of natural thonum and natural before the Commission, awaiting approval for uranium, based on licensed activities at the facil-publication.

ity and available characterization data. Subse-quent re-evaluation of gamma spectra by an NRC In summary, the final rule would amend the regu-contractor indicated elevated levels of Th-230 also lations that licensees must meet to ensure that occurnng m slag that was stored onsite. These they have adequate decommissioning funding in tievated levels were not determmed in the origmal place. The major changes in this final rule are:

analyses because elevated Th-230 had not been (1) each decommissioning funding plan must suspected (other than m, eqmlibnum with U-238/

contain a licensee certification that funding is in 234). Had NRC not conducted a gamma spec,

place and a signed original of the financialinstru-trommetnc analysis, it is likely that much of this ment that is in place; (2) a decommissioning contammation might have been overlooked. 'Ihe funding plan must be submitted by licensees that cause of the elevated levels, especially Pa-231 and are required to submit one, but have not done so Ac-227, is under mvestigation.

because they are presently in the timely renewal process;(3) financial assurance must be sub-mitted 1 y licensees who have submitted a decom-Facility managers should be alert for instances 7

missiomng plan and have not already provided where radioactive materials may be present at adequate financial assurance; (4) heensees must elevated levels, yet are overlooked because:

increase or decrease the amount of financial (1) they are not known to have been used or pro-assurance, to cover the detailed cost estimate duced at a site;(2) they are not readily detected in submitted with the decommissionmg plan; and the field, using exposure rate measurement; and/

(5) licensees may decrease the amount of financial or (3) their gamma photo peaks (or photo peaks assurance, as decomnussm, nmg proceeds.

of short-lived decay products) are not readily apparent because of the presence of other ISOTOPIC ANALYSIS IMPORTANT TO SITE gamma-emitting radionuclides. NRC staff is CilARACTERIZATION aware of the potential for additional unantici-pated radioactive material contamination to be The U.S. Nuclear Regulatory Commission recently present at decommissioning sites and will review promulgated new regulations _that establish time-site characterization information with this in tables and scheduling limitations on licensees that mind.

I 4

' ASSAY OF PURE BETA EMITTERS up of patients and use of NRC consultants. NRC

- staff provided a status report on the rulemaking

. On September 29,1994, the U.S. Nuclear Regu.

" Release of Patients Containing Radiopharma-

latory Commission issued Information Notice ceuticals or Permanent Implants" and provided' (IN) 94-70, " Issues Associated with Use of.

an overview of a planned Advance Notice of Strontium-89 and Other Beta Emitting Radio.

Proposed Rulemaking for 10 CFR Part 35. The C

pharmaceuticals." His notice discusses assay of ACMUI reviewed and adopted final bylaws for radiopharmaceuticals containing pure beta.

the committee.

emitters. De IN states that until appropriate measuring instruments and standards are devel-Copies of the transcripts and summary minutes the manufac-h & Mg m M& h@ & P61ic oped and available, reliance on,t dosage may be turer,s stated activity of the um Document Room (202-634-3273)-

the most accurate means, and an acceptable method, of determmmg the activity of the, patient ne next meeting of the ACMUI will be held dosage. This statement implies that there is no May 11-12,1995, and will be noticed in the instrumentation available that can be used to FedemlRegister, accurately assay beta-emitters. Since the IN was AVAILABILITY OF REPORT ON SAFETY 1

written, NRC has become aware of certain manu-PROGRAMS AT MEDICAL FACILITIES

- facturers that have developed instrumentation which is capable of accurately assaying beta-De U.S. Nuclear Regulatory Commission has emitters. Part 35 does not require hcensees to issued a draft report entitled, " Management of measure patient dosages of radiopharmaceuticals Radioactive Material Safety Programs at Medical containing pure beta-emitters provided they are Facilities"(NUREG-1516). This draft report, unit dosages obtained from a manufacturer or prepared by NRC staff with input from Agree-preparer licensed pursuant to 10 CFR 32.72 or ment States and professional medical organi-equivalent Agreement State requirements. Other-zations, is available for review and comment. The wise, the licensee is required to measure by direct comment period expires December 31,1995.

measurement, or by combination of measure-Copies of the report may be obtained by written ments and calculations, the activity of each request or telefax (301-415-2260), at no charge, dosage of an alpha or beta-emitting radionuclide, from Distribution Services, Printing and Mail before medical use. Ucensees may also use any Services Branch, Office of Administration, U.S.

available instrumentation to assay patient dosages Nuclear Regulatory Commission, Washington, DC containing pure beta-emitters, to satisfy this 20555-0001. For further information, contact Janet requirement.

Schlueter, NUREG Project Manager, Office of -

Nuclear Material Safety and Safeguards, Mail i

SEMI-ANNUAL MEETING OF THE Stop T-8F5, USNRC, Washington, DC l

ADVISORY COMMITTEE ON MEDICA.L 20555-0001.

)

USES OF ISOTOPES QUALITY MANAGEMENT (QM) NOTES The U.S. Nuclear Regulatory Commission's Advisory Committee on Medical Uses of Isotopes Quality Management Program Reviews:

(ACMUI) held its regularly scheduled semi-All of the quality management programs (QMPs) annual meetmg on November 17-18,1994, at the initially submitted by U.S. Nuclear Regulatory NRC Headquarters office in Rockville, Maryland.

Commission licensees have now been reviewed.

Agenda items included: discussion of the final As a result of the review letters, many licensees rule and guidance on the rule " Preparation, Trans-have provided modified QMPs to the NRC fer, and Use of, Byproduct Material for Medical regional offices. These revised QMPs will be Use"; status of implementation of the Quality reviewed as preparation for inspections, when Management Rule; discussion of a reexammation licenses are renewed, or when the license is of NRC enforcement policy; a status report of the amended to add a modality. The results of those National Academy of Sciences review of NRC's reviews will be communicated to the licensee at medical use regulatory program; discussion of those times.

1 fractionated therapy procedures; discussion of the

" Abnormal Occurrence Criteria Revisions"; dis-Dose Ranges:

cussion on inadvertent administrations of by-product material to the wrong patient and related An article in the September 1994 issue of the patient notification requirements; and a discus-NMSS Licensee Newsletter, NUREG/BR-0117, sion of misadministration issues regarding follow-regarding the requirement to specify a specific 5

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dose or dosage, rather than a range, when Note that these are only summaries of U.S. Nu-

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preparing written directives, has generated clear Regulatory Commission generic communica-considerable reaction from the medical tions. If one of these documents appears relevant community, resulting in numerous telephone to your needs and you have not received it, please inquiries to NRC. Most of the callers represented call one of the technical contacts listed below.

users of radioactive drugs for therapy, most often sodium iodide (I-131). Typically, the callers Administrative 12tters (ALs) explained that the authorized user specified the dosage in a range because the amount of I-131 A. AL 95-01, " Change in Commercial Telephone received varied from that which was ordered. It is and Facsimile Numbers at Nuclear Regulatory understood, from an operating perspective, that li.

Commission Headquarters," January 23,1995.

censees may not know in advance precisely the Contacts:

quantity of sodium iodide that a radiopharmacy Rashida Alam,IRM,301-415-7500 will have available for distribution at any given T. Greene, NRR,301-504-1175 time, and, therefore, requesting the dose in a range may be appropriate. This issue can be This letter informs addressees that the commer-addressed by assaying the s, odium iodide dose cial telephone and facsimile numbers for one of received before admmistration, modifymg thg the two office buildin8s at NRC Head uarters are 9

written directive, and then having the authonzed being changed.

user, or a physician under the supervision of the authorized user, sign and date the modified B. AL 95-01, Supplement 1, " Change in Com-written direct 1ve. All these steps must occur mercial Telephone and Facsimile Numbers at before adm,,stration to the patient. For Nuclear Regulatory Commission Head-mi therapeutic applications of I-131, this approach quarters," February 2,1995.

Imposes mmimal burden on licensees because authorized users are typically directly involved in Contacts:

administration of the radioactive drug to the Hemy Bailey, AEOD,301-415-7483; patient. In the case of diagnostic applications of C. Vernon Hodge, NRR,301-504-1861 greater than 1.1 megabecquerel (30 microcunes) of I-131, licensees may review their clinical This supplement to AL 95-01 informs addressees procedures to determine what administration that the telephone numbers for the NRC Opera-steps can be incorporated to achieve this tions Center will not change even though other objective.

telephone numbers at NRC Headquarters are being changed.

The requirement to specify a specific dose or Information Notices (ins) dosage, when preparmg a written directive, is not a new requirement. The cited article in the Sep-A. IN 89-25, Revision 1, " Unauthorized 'Ilansfer tember issue was mtended to clarify the existing of Ownership or Control of Licensed requirement. NRC believes that the prescribeg Activities," December 7,1994.

dose or dosage listed on the written directive is the responsibility of the authorized user and

Contact:

should be clearly stated. This is necessary to Susan Greene, NMSS,301-415-7843 ensure that the decision regarding the actual amount of radiation to be administered to the This revision to IN 89-25 clarifies previous guid-patient is made by a licensed medical practi-ance concerning information to be submitted to tioner. At many licensees' facilities, an individual NRC before a change of ownership or control.

under the supervision of an authorized user ad-The notice incorporates recent information con-ministers doses (dosages) as prescribed on a cerning the transferee's liability for open inspec-written directive, with no authorized user present tion issues and potential enforcement actions during the procedure. 'Iherefore, the individual from past violations, and responsibility for decon-administering byproduct material, or radiation tamination activities and decommissioning of the therefrom, needs clear instructions as to the intent site.

of the authorized user.

B. IN 94-89, " Equipment Failures at Irradiator Facilities," December 28,1994.

GENERIC COMMUNICATIONS ISSUED

Contact:

December 1,1994 - February 1,1995 Douglas Broaddus, NMSS,301-415-5847 6

His notice alerts all irr:diator licensees to several This letter notifies all current licensees end :ppli-equipment f-ilures-some of which have generic cants for uranium conversion and fuel fabrication implications-that involve wet source storage facilities about the need to implement a Fire irradiators.

Hazard Analysis and a Pre-Fire Plan, and requires that all addressees submit a written C. IN 95-01," DOT Safety Advisory: High-response to the letter.

Pressure Aluminum Seamless and Aluminum Composite Hoop-Wrapped Cylinders,"

FEDERAL REGISTER NOTICES January 4,1995.

November 1,1994 - February 1,1995 Contacts-Jim Wigi;inton, NRR,301-504-1059 DRAFP REGULATORY GUIDES (NOTICE Jerry Roth, NMSS,301-415-7257 OF AVAILABILITY)

His notice alerts all NRC licensees to a safety Proposed revision 2 to Regulatory Guide 10.5,

,'A plications for Licenses of Broad Scope,,

P concern for workers identified in the safety 59 FR 55141, November 3,1994.

I advisory recently issued by the Research and Special Programs Administration of the U.S.

Proposed revision 1 to Regulatory Guide 8.29, Department of Dansportation (DOT).

.. Instruction Concerning Risks from Occupa-fan"u ry 13, D. IN 95-07, "Radiopharmaceutical Vial Break-5.

age dun,ng Preparation," January 27,1995.

j FINAL REGULATORY GUIDES (NOTICE OF i

AVAILABILITY)

I

Contact:

Sally Merchant, NMSS,301-415-7874 Revision 3 to Regulatory Guide 5.52, " Stand-This notice alerts all medical licensees authorized ard Format and Content of a Licensee Physi-to use byproduct material for diagnostic proce-cal Protection Plan for Strategic Special dures to a potential problem that can occur when Nuclear Material at Fixed Sites (Other than heating radiopharmaceuticals.

Nuclear Power Plants)," 60 FR 2799, Bulletins (Bis)

REQUEST FOR COMMENTS A. BL 95-01," Quality Assurance Program for i

T ansportation of Radioactive Material,"

10 CFR Part 35, " Request for Comments

{

January 13,1995.

Regarding Potential Modification of NRC's

.l Therapy Regulations," 59 FR 55068, Novem-Contacts; ber 3,1994.

Thomas Matula, NMSS,301-415-7873; John Jankovich, NMSS,301-415-7274

Contact:

Patricia K. Holahan, NMSS (301) 415-7847.

l This bulletin: (1) notifies all radiography licensees PROPOSED RULES about the failure of some licensees to have an NRC-approved quality assurance program for (Note that all Parts under " PROPOSED transportation of radioact,ve materials; (2) re-i RULES" are from 10 CFR.)

quests that all radiography heensees implement the actions described in the bulletin; and (3)

Part 2, "NRC Size Standards"(used to qualify requires that all radiography licensees complete an NRC licensee as a "small entity" under the and return the form provided in the bulletm.

Regulatory Flexibility Act),59 FR 61293, Generic Letiers (GLs)

Contact:

A. GL 95-01, "NRC Staff Technical Position on Sarah N. Wigginton, ADM (301) 415-7158.

Fire Protection for Fuel Cycle Facilities,"

January 26,1995.

Parts 11 and 25, "NRC Licensee Renewal /

Reinvestigation Program"(for licensee "U"

Contact:

and "R" special nuclear material access A. Datta, NMSS,301-415-8109 authorizations and "Q" and "L" access 7

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cuthorizations),59 FR 66812, December 28,-

1. Michael J. Berna, IA 94-4132 -

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'1994; An Order Prohibiting Involvement in NRC-'

Contact:

Liceused Activities (Effective Immediately)

James J. Dunleavy, ADM (301) 415-7404.

was issued November 15,1994, to the above '

individual, ne Order was based on inspec-Parts 20,30,40,61,70, and 72, " Termination tion and investigation results that concluded or Dansfer of Licensed Activities: Recordi

' that the individual deliberately violated 10 Keeping Requirements," 59 FR 66814, CFR 30.10 by failing to perform field audits of December 28,1994.

radiographers, created false audit records, -

and requested others to create false records.

Contact:

He Order removes the individual from U.S.

Mary 1. Thomas, RES (301) 415-6230.

Nuclear Regulatory Commission-licensed activities for 3 years. In addition, the indi- -

Parts 20 and 35, " Medical Administration of vidual is to notify NRC the first time that he.

' Radiation and Radioactive Materials," 60 FR engages in licensed activities after the end of 4872, January 25,1995, the prohibition period.

Contact:

2. Richard E. Odegard, IA 94-018 Stephen A. McGuire, RES (301) 415-6204.

An Order Prohibiting Involvement in NRC-FINAL RULES Licensed Activities (Effective immediately) was issued August 26,1994, to the above indi-(Note that all Parts under " FINAL RULES" vidual. The action was based on the individual are from 10 CFR.)

providing false testimony to NRC, and delib-erately failing to train and certify employees in Parts 30,32, and 35, " Preparation, Ransfer for radiation safety, as required by the license Commercial Distribution, and Use of -

conditions. The Order prohibits the individual Byproduct Material for Medical Use," 59 FR from engaging in NRC-licensed activities for 5 i

61767, December 2,1994.

years, and after the prohibition has expired, a

requires him to provide notice to NRC of I

Contact:

acceptance of any employment in NRC-Anthony N. 'Ihe, RES (301) 415-6233.

licensed activity, for an additional 5-year Part 72, " Notification of Events," 59 FR 64283, December 14,1994.

3. William W. Backus Hospital, Norwich, Connecticut, Supplement VI, EA 94-150 Naiem S. Tanious, RES (301) 415-6103.

A Notice of Violation and Proposed Imposi-tion of Civil Penalty was issued November 7, Part 72, " List of Approved Spent Fuel Storage 1994, to emphasize: (1) the significance of vio-Casks: Addition," 59 FR 65898, December 22, lations associated with a misadministration at

1994, that facility; and (2) the importance of vigilant management attention to ensure that similar

Contact:

violations do not recur. The misadministration Gordon E. Gundersen, RES (301) 415-6195.

involved iodine-125 seeds as permanent im-plants. As a result of the misadministration, Part 32, " Requirement to Report Ransfers of the patient's prostate gland, which contained Devices to Generally Licensed Persons," 60 the majority of the seeds, was subsequently FR 3735, January 19,1995.

removed.

Contact:

4. Indiana Regional Cancer Center, Indiana, l

John W. Lubinski, NMSS (301) 415-7868.

Pennsylvania, EA 93-284 A SAMPLING OF SIGNIFICANT An Order Modifying License and Suspending ENFORCEMENT ACTIONS AGAINST License (Effective Immediately) and Demand MATERIAL LICENSEES for Information were issued November 16, 1993, to modify the license, to remove the Ra-One way to avoid regulatory problems is to be diation Safety Officer (RSO), and sole author-aware of enforcement problems others have faced.

ized user from engaging in activities under the 8

license. NRC had serious concerns about com-agement oversight of NRC licensed activities.

pliance with NRC regulatory requirements, ne action was based on the failure to have which involved: (1) performance of activities written directives signed by an authorized user with a strontium-90 source that was not au-before administering iodine-131 as sodium thorized by the license; (2) failure to provide iodide in quantities greater than 1.1 megabec-complete and accurate information to NRC querel(30 microcuries), which led to a mis-inspectors; and (3) failure to have an adequate administration. Other violations involved suivey made, which resulted in a Novem-training, lack of a procedure manual protocol, ber 22,1992, event at the facility. Subse-and incomplete evaluation of previous prob-quently, the licensee requested termination of lems involving written directives.

the license.

8. Memorial Hospital, Towanda, Pennsylvania,

5. Amoco Oil Company, Whiting, Indiana, Supplements IV, V, VI, EA 94-191 Supplements VI and VII, EA 93-128 A Notice of Violation and Proposed Imposi-tion of Civil Penalty was issued October 17, A Notice of Violation and Proposed Imposi-1994, to emphasize: (1) the importance of,

tion of Civil Penalties and Demand for Infor-aggressive management oversight of the radia-mation were issued November 15,1994,to emphasize the licensee's responsibility to t, son safety program, so as to ensure that licensed activities are conducted safely and m, properly manage and support licensed activi-accordance with requirements, and violations, ties and NRC's significant concern about when they exist, are promptly identified and licensee supervisors' involvement in willful corrected; and (2) the need for ensuring that violations. He action was based on violations corrective actions are long-last, g. Re acuon m

involving:(1) failure of the RSO to perform was based on violations that represented a audits; creation of false audit records by the breakdown in the radiation safety program.

RSO and two assistant RSOs; and the RSO They included, among others, the failures to:

deliberately providing false information to Prohibit the storage of food and drink in areas NRC concerning pre-announcement of quar-where radioactive materials are used; wear a terly audits; and (2) a breakdown in the finger exposure monitor during the assay of management of NRC-licensed activities.

radiopharmaceuticals; dispose of radioactive waste in designated, and properly shielded,

6. Milwaukee County Medical Complex (John L receptacles; provide radiation safety traimng Doyne Hospital), Milwaukee, Wisconsin, to personn,el; conduct,a complete formal, Supplement IV, EA 94-074 annual review of the heensee's as low as is reas nably achievable (ALARA) program, A Notice of Violation and Proposed Imposi-remw ra au n smveys quartedy; note de tion of Civil Penalty was issued June 23,1994, apparent exposure rate from a dedicated to emphasize the need to ensure that licensed check source, determined at the time of cali-activities are conducted safely and employees bration on each survey instrument, and check are protected from, unnecessary radiation the dose calibrator for constancy each day of exposures. He action was based on an over-use' exposure event, to the licensee's physicist (an authorized user), that had a substantial poten-

9. South Bend Medical Foundation, South Bend, tial for a far more serious exposure. During Indiana, Supplements IV, V, VI, EA 94-238 calibration of a new teletherapy unit, the physicist and the RSO bypassed interlocks to A Notice of Violation was issued November the teletherapy room and entered the room 29,1994, based on violations involving a with the source in the exposed position. He breakdown in the use of chromium-51. He physicist had no survey instruments, and the violations included using licensed material in RSO had a survey instrument with the audible places not authorized by the license, failing to alarm turned off.

conduct proper surveys or perform dose cali-brator linearity checks, and failing to comply

7. St. Joseph Mercy llospital, Pontiac, Michigan, with the requirements of the Department of Supplement VI, EA 94-156

'Iransportation. A civil penalty was not issued because of prompt and extensive corrective A Notice of Violation and Proposed Imposi-actions, and because the area of concern-the tion of Civil Penalty was issued October 19, use of chromium-51-had not been previously 1994, to emphasize the need for effective man-inspected and represented only a small seg-9 l

maaf the licensee's program, which had a to verify all radioisotope dosages; implementing a b

pd p Normance record.

unit dose system; obtaining the services of an assistant radiation safety officer; and conducting A SAMPLING OF SIGNIFICANT EVENTS monthly and quarterly audits of the Nuclear REPORTED TO HRC BY NRC NUCLEAR Medicine Section, for at least 1 year.

MATERIAL LICENGES On October 20,1993, NRC issued a Confirmatory Event 1:

Deliberate Overdos.mg f. Patients Order Modifying License requiring specific pro-durmg Diagnostic Studies, and cedures and verifications to prevent any further Falsification of Records unauthorized increases in patient doses. On Date Reported: July 19,1993 May 23,1994, NRC issued an Order against a former nuclear medicine technologist of the L.icensee:

Ball Memorial Hosp.tal, licensee. He Order required the technologist to i

ufuncie, Indiana comply with the following: (1) prohibited the On July 19,1993, the U.S. Nuclear Regulatory technologist's involvement in NRC-licensed activi-Commission was notified that nuclear medicine ties for 1 year; (2) required the technologist t,o technologists employed by the licensee had Provide a copy of the Order to any prospective increased the dosages of radiopharmaceuticals employer who engages m NRC-heensed activities, used in diagnostic studies, to reduce imaging f r a 3-year penod; and (3) required the tech-time. NRC was also informed that the technol-n I gist to notify NRC, within 20 days of accept-l 28 emP oyment mvolvmg NRC-h,eensed activities.

ogists had falsified the required records of the dosages administered.

Event 2:

Medical Herapy Misadministration An NRC inspection revealed that since 1988, Involving Strontium-89 nuclear medicine technologists employed by the Date Reported: August 9,1994 licensee had been admmistermg radiopharma-ceutical doses above the approved dose range; for Licensee:

Veterans Affairs Medical Center, diagnostic image studies, by as much as 40 per-Long Beach, California cent. The inspection also verified tha} after administering high dous vehnologists entered On August 9,1994, the licensee's radiation safety false information in b 7 w9 red records. The officer (RSO) notified NRC of a misadministra-i dosages were increaseu ior imaging studies of the tion involving a therapeutic dose of strontium-89 lung, liver, bone, and gastrointestinal tract, using (Sr-89). The RSO reported that a patient sched-technetium-99m and eenon-133. NRC inspectors uled to receive 185 megabecquerel(MBq)(5 milli-did not identify medical misadministrations, as curie [c Ci]) of thallium-201 (a radiopharmaceut-defined in 10 CFR 35.2, as a result of this practice ical not regulated by NRC) for a myocardial d administering high doses for diagnostic Perfusion study was mistakenly administered 148 imaging.

MBq (4 mci) of Sr-89. Based on the misadmin-istration of the Sr 89, the licensee estimated that According to the licensee, one technologist told the patient received 250 centigray (250 rads) to the licensee officials that dosages were increased to surface of the bone. The RSO reported that no minimize patient discomfort, to reduce imaging action was taken to mitigate the consequences of time for critically ill patients, and to enhance the the dose (i.e., administration of calcium as a clarity of images for studies performed on obese blocking agent) because the patient had a pre-patients.

existing heart condition that could have been exacerbated by administering calcium. The ne licensee conducted an internal investigation.

licensee a!so stated that medical experts were Based on the findings of this investigation, the contacted to assist in an assessment of potential licensee initially suspended two nuclear medicine health effects to the patient. In addition, the technologists from all NRC-licensed activities.

licensee reported that with the exception of emer-Nbsequently, the licensee terminated the employ.

gency procedures, it had voluntarily suspended all ment # one of the two individuals; the other nuclear medicine procedures involving the intra-indivional was allowed to continue to perform venou; administration of radiopharmaceuticals duties that do not involve NRC-licensed activities.

and had initiated an internal investigation of the misadministration.

he licensee also cc.mmitted to a number of corrective actions. Ome of the corrective actions he cause of the misadministration was attributed included: assigning a pharmacist or a radiologist to the administering technologist's failure to verify to

the dosage (by reading the labcl on the syringe) 1994, and indicated that the iridium implant was before injection.

not secn.

Corrective actions proposed by the licensee in-Because of catheter displacement, the tumor dose cluded the following: (1) physically separating was significantly reduced and estimated to bc 620 diagnostic unit dosages from therapeutic radio-cGy (620 rads) or 31 percent of the intended dose.

pharmaceutical dosages in the licensee's hot lab; The remaining dose of 1380 cGy (1380 rads) was (2) packaging unit dosages received from a local delivered to an unintended site.

radiopharmacy in different containers, according to isotopes; and (3) retraining technologists in De Patient and the referring physician were noti-requirements for identifying radiopharmaceuticals fied of the event by the treating physician on before injection.

August 4,1994. An NRC medical consultant was retained to perform a clinical assessment of this Event 3:

Medical Brachytherapy misadministration. The medical consultant con-Misadministration cluded that it is improbable that the patient will experience any long-term Date Reported: August 15,1994 of the exposure to the unm, consequences as a result tended treatment site.

Licensee:

North Memorial Medical Center, Robbinsdale, Minnesota The licensee has determined that the catheter movement caused a misadministration of the in-On August 15,1994, the licensee informed NRC tended dose. Two possible explanations for the that a patient received 1380 centigray (cGy)(1380 catheter movement could be the following: (1) fail-rads) to the wrong treatment site during a brachy-ure to properly secure the catheter in place with therapy treatment for metastatic lung cancer. On tape; or (2) nasal discharge decreasing the adhes-August 3,1994, a catheter was inserted into the ive capability of the tape.

patient's bronchus and a ribbon containing 20 seeds of iridium-192 having a total activity of The licensee's corrective actions included: amend-673.4 megabecquerels (18.2 millicuries) was in-ing the nursing staff procedure so that the attend-serted into the catheter and moved to the pro; er ing physician will be contacted if there are further i

treatment k> cation. The treatment plan was in-questions; nurses will be directed to the standing tended to deliver a prescribed dose of 2000 cGy protocol for obtaining an administrative consulta-(2000 rads) to the intended target. The treatment tion; additional training during in-service; docu-i began at 11:15 a.m. on August 3,1994, and con-menting the final length of the catheter in the tinued until its scheduled completion,10:15 a.m.

patient chart; and documenting the position on on August 4,1994.

each visit to the patient's room.

At about 7:00 p.m. on August 3,1994, a nurse in-

,------------------------ 3 formed the physician that the visible portion of l

l l

the catheter appeared to be protruding approxi-l CORRECTION NOTICE FOR " SAMP mately 10 to 12 inches from the patient's nose.

I OF SIGNIFICANT EVENTS" ITEM This was a significantly greater protrusion than l

l l typographical errors in the second paragraph previously observed, indicating that the catheter In the last issue (Dec. 94/Jan. 95), there were I had moved from its initial placement. The nurse l

of the description of the misadministration at l secured the catheter in place with additional tape.

I An x-ray was made, but the physician reported it I

the University of Cincinnati (see page 11). All l to be fogged. De physician stated that, based on l of the metric numbers in the paragraph were I

the information available to him at that time, he i in units of microsieverts, but the abbreviations I determined that the catheter and ribbon had I were printed as "Sv" instead of "uSv." In addi l I

moved, but that the tumor was receiving some l tion, the number "1.6 mrem" should be "16 i

radiation dose, and he continued the treatment.

mrem." We apologize for any inconvenience l

The iridium-192 seeds were removed on August 4 l this may have caused.

I l

as planned. On August 4,1994, a staff radiologist l

read the portable x-ray film taken on August 3, I

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