ML20036A130

NMSS License Newsletter.No. 93-1

ML20036A130
Person / Time
Issue date:	03/31/1993
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N93-1, NUREG-BR-117, NUREG-BR-117-N93-1, NUDOCS 9305100084
Download: ML20036A130 (12)

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

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4 TRAINING PROGRAM FOR RUSSIAN tion Safety Regulation, ne visitors basically are inter-GOSATOMNADZOR (GAN) PERSONNEL ested to learn how,in a free enterprise society such as ours, a government agency regulates an important indus-The Office of Nuclear Material Safety and Safeguards try in the private sector.They are studying NRC's regula-(NMSS) has been providing training to a group of execu-tory structure and interactions between NRC and its li-tives fro:n the Russian government agency, Gosatom-censees. They are also interested in learning about the nadzor (GAN), which is the Russian counterpart of the interactions between the corporate owners of the indus-U.S. Nuclear Regulatory Commission, since late March try and their site operating organizations.

1993.nis is only one segment of a training program for GAN executives and specialists, under a Memorandum l2ter groups of Russians will be specialists who will re-of Meeting signed by James M. Taylor, Executive Direc-ceive training in various areas, from use of American So-tor for Operations, NRC, and Alexander Gutsalov, First ciety of Mechanical Engineers' Boiler and Pressure Ves-Deputy Chairman, GAN,in December 1992. The meet-sel Codes to creation and development of an MC&A ing was held to establish plans for implementation of an system. The program is likely to continue for several international agreement known as the Lisbon Initiative.

years.

Seven projects, called Priorities, to train GAN person-nel, have been agreed on and approved for funding REORGANIZATION OF THE OFFICE OF through an interagency agreement that NRC signed with NUCLEAR MATERIAL SAFEiFY AND the U.S. Agency for International Development.

SAFEGUARDS Effective February 7,1993, certain functions and organ-Several NRC offices and regions will participate in the zational elements in the Office of Nuclear Material program.ne Office of Nuclear Reactor Regulation has Safety and Safeguards (NMSS) were reorganized. The the lead for Priority 1. He current NMSS effort, a part organizational changes will provide significant benefits of Pnonty 1, mcludes the licensing processes of fuel cy-by enabling a more efficient and effective conduct of the cle, industrial, medical, and academic facilities and regu-NMSS mission, through consolidation of the fuel cycle latory mstruments and methods for ensuring operational safety. Several NMSS staff members are involved in the facilities activities (safety and safeguards) in a single disi-effort, which also includes a visit to Westinghouse Elec-sion. The changes will also allow more focused manage-ment attention within NMSS for time-sensitive matters tric Corporation's nuclear fuel fabrication facility at Co-lumbia, South Carolina.

and high-visibility tasks (e.g., fuel facility safety issues and the new enrichment activities resulting from the En-ergy Policy Act of 1992). He impact of the Act is far-NMSS will again be actively involved in Priority 6 of the reaching for NRC, in that it gives NRC responsibility for program, under which NRC will assist GAN in creating the certification of health, safety, and safeguards ele-and developing a nuclear Material Control and Account-ments of the gaseous diffusion plants presently operated ing (MC&A) system. His, in turn, is a part of the " Safe by the Department of Energy.

and Secure Dismantlement"(SSD) program to assist the components of the former Soviet Union in dismantling He new Division of Fuel Cycle Safety and Safeguards their nuclear weapons. NRC's interactions with G AN, in (FCSS)(formerly the Division of Safeguards and Trans-this part of the program, are expected to lead to the portation) has had a new branch created, the Enrich-eventual signing of a U.S.-Russia SSD agreement.

ment Branch. The Division Director is Robert F.

Burnett. The Transportation Branch transferred to the The first Russians visiting NRC, under this training pro-Division of Industrial and Medical Nuclear Safety, and gram, are managers of GAN departments responsible the Branch structure remains unchanged. An organiza-for nuclear safety; one of them, Mr. Alexander Dmitriev, tion chart that depicts the new NMSS organization i

heads the Department of Nuclear Fuel Cycle Installa-follows.

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9305100084 930331 PDR NUREG I

BR-0117 R PDR

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NEW NMSS ORGANIZATION 1

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Office of Nuclear Material Safety and Safeguards Director Robert F. Bemero Deputy Director Guy A. Arlotto I

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i Fuel Cycle Safety and Safeguardo Divlelon industrial Medical and Nuclear Safety Divleion Director Robert F. Burnett Director Richard E. Cunningham i

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I Deputy Director Deputy Director for Facilities for Operatione John T. Greevee Elizabeth G. Ten Eyck I

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I Uconoing Operatione Operatione Source Containment Branch Branch Branch and Devicoe Branch Vacant Chief C. Smith Chief F. Combe Chief C.Haughney Enrichment Regulatory & International Medical, Academic Transportation Branch Safeguards Branch and Commercial Use Branch Safety Branch CNef J. Hickey Chief T. Sherr Chief J. Glenn Chief C.MacDonald MARCH 1993 NMSS LICENSEE 7.

NRC Trending Program for Safeguards NEWSLE' ITER CONTENTS Events (Contact: Joan Higden, Page 301-504-2477)........................... 5 8.

Excess Plutonium.238/ Beryllium Neutron 1.

Training Program for Russian Gosatomnadzor (GAN) Personnel Sources (Contact: Richard Gramann, 301 -504-24 56)........................... 6 (Contact: Amar Datta, 301-504-2536)....... 1 9.

Proposed Uniform Manifest Rulemaking 2.

Reorganization of the Office of Nuclear Material (Contact: William Lahs, 301-504-2569)..... 6 Safety and Safeguards (Contact: John Greeves,301-504-3334)..... 1

10. Update on Radiopharmacy Rulemakm.g (Contact: Mark Rotman, 301-504-2769)..... 6 3.

So You're the New Radiation Safety Officer (Contact: Carl Paperiello,301-504-2659).... 3

11. Review of NRC's Medical Use Program (Contact: Dr. Patricia Holahan, 4.

Rules Published (December 8,1992-301-504-2694)........................... 7 March 16,1993)

12. High-Dose-Rate Afterloading Urachy-(Contact: Paul Goldberg. 301-504-2631)..... 3 therapy XMisadministration and less of Control of a High-Activity Iridium-192 5.

Regulatory Guide Published (November 13, Source at Indiana. Pennsylvania, on 1992-March 16,1993)(Contact:

November 16,1992 Paul Goldberg, 301-504-2631)..............

4 (Contact: Robert Ayres,301-504-3423)..... 8 6.

Information Notices Published (December 15,

13. A Sampling of Significant Events Reported to 1992-March 22,1993)(Contact:

NRC (Contact: Harriet Karagiannis, Paul Goldberg. 301-504-2631)............. 4 301 -4 92-4 25 8)........................... 9 2

14. A Sampling of Significant Enforcement Actions understand why a business that knows how to audit its against Material Licensees (Contact:

financial activities does not audit its safety activities.

Joe DelMedico,301-504-2739)........

10 Do you have the time and resources to be an RSO? This can be a problem, particularly if the RSO function is an Comments, and suggestions you may have for ancillary assignment. It can generally work well for a information that is not currently bemg m-small program in which the RSO is a user and has cluded, that might be helpful to licensees, day-to-day contact with the other users. One hospital with should be sent to:

a few physician users and technologists in one section of E. Kraus the facility is such an example. Others might include a small radiography company with one office and several NMSS Licensee Newsletter Editor ra gra ers, or a sman mscarch facMy. Mems usually a@nse when a small business grows, partic Office of Nuclear Material Safety and Safe-guards when it adds branch offices, and the part-time RSO can One White Flint North, Mail Stop 6-E-6 no longer keep track of activities at other k) cations.

U.S. Nuclear Regulatory Commission Washington, D.C. 20555 Doyou want to be an RSO? An RSO can be unpopular.

Sometimes you have to be a cop. Sometimes you have to say no. Don't let your name get on the license if you think SO YOU'RE THE NEW RADIATION SAFETY you g t a M to teach or do Sesead aM not to be a 8"

• th feehg. I ongmaHy wamed m teach, OFFICER too. I suppose, m. a way, that is what I am doing now, by writing this article. As an RSO, you are a regulator just What does it mean, if you agree to be named as the new like me. A regulator has to have the will to regulate.

radiation safety officer (RSO) on an NRC license? It means you have the knowledge and skill, the resources Do you have clout in your organization?

(i.e.,

and time, the will, and the clout in your organization to Clout-Chicagoese for power and influence). Or, are you ensure that activitics involving radiation and radioactive so low in your organization that no one listens to you?

materials are conducted safely, and all NRC require-Does your major user write your performance appraisal ments, both in the regulations and those specific to your or control your salary or bonus? If so, you may have a license, are being met. Although you can delegate tasks, problem. You must have the authority to stop an unsafe you have the responsibility, activity or an activity in violation of NRC requirements.

Or at least you must have ready access to someone who How much knowledge do you have to have? It depends.

can stop it. Organizations that prevent an RSO from You don't need an advanced degree in nuclear physics if domg his or her job are probably in violation of NRL your responsibility is limited to scaled sources contained regulations.

in devices or instruments like soil testing gauges, gas S you're the new RSO? Good luck! If you have a chromatographs, or level detectors. On the other hand, an RSO for a major broadscope university, medical problem or a concern, call NRC. The number is on your Form 3.

center, or manufacturer will probably need a fairly good scientific background, including substantial knowledge of radiation characteristics and methods of detection. The The writer, Dr Carl J. Paperillo, was formerly Deputy broadscope RSO needs to be sensitive to unique uses that Regional Administrator of Region Ill. He will assume can create unanticipated risks, as well as having an the position of Director, Division of Industrial and understanding of all the diverse uses at these institutions.

Medical Nuclear Safety, NMSS, on July 1,1993.

There is another skill much more frequently overlooked RULES PUBLISHED in the selection of an RSO. Can you manage? If there is a large program under your license (i.e., a lot of users, (December 8,1992-March 16,1993) diverse places of use, and/or branch offices) can you establish management systems to ensure that you know FINAL RULES everything that has to be done is being done? For Licenses and Radiation Safety Requirements for example, if your license involves a lot of gauges at diverse e

locations used by numerous employees, knowledge of Irradiators dose calculations or shielding or biological effects is not much help if you don't know if your users are. properly

1. Published: February 9,1993 trained, wearing the proper dosimetry, and transporting 2.

Contact:

Dr. Stephen A. McGuire,301-492-3757 and stonng gauges correctly. Most of the cml penalty enforcement actions with which I have been involved Disposal of Waste Oil by Incineration e

result from a failure of a licensee to manage the radiation safety program correctly. The major management failure L Published: February 24,1993 is failure to know whether activities are bem, g conducted in accordance with NRC requirements. I fail to 2.

Contact:

Cathy Mattsen,301-492-3638 -

3

PROPOSED RULES B. "Recent Revisions to 10 CFR Part 20 and Change of Implementation Date to January 1,1994," 1N 93-3, o Self-Guarantee as an Additional Financial January 5,1993 Assurance Mechanism Technical Contacts:

Joseph E. DeCicco,

1. Published: January 11,1993 Office of Nuclear Material Safety and 301 5 06h 2.

Contact:

Clark Prichard,301-492-3734 o Timeliness in Decommissioning of Materials Charleen T. Raddatz, Facilities Office of Nuclear Regulatory Research, 301-492-3645

1. Published: January 13,1993 This notice informs licensees of the 1-year delay of the 2.

Contact:

Paul J. Kovach,301-492-3729 deadline for implementation of the revised 10 CFR Part 20, of two recent changes to the revised Part 20, and of the Procedures and Criteria for Onsite Storage of publication of final and draft regulatory guides related to o

12)w-Level Radioactive Waste the revised Part 20.

1. PA'*d: February 2,1993 C. " Investigation and Reporting of Misadministrations 2.

Contact:

Robert Nelson,301-504-2004 by the Radiation Safety Officer " IN 93-4, January 7,1993 Technical

Contact:

REGULATORY GUIDE PUBLISHED Patncia K. Ilolahan,301-504-2694 (November 13,1992-March 16,1993)

This notice provides guidance to licensees on new DRAFT GUIDE requirements for misadministrations in the " Quality Management Program and Misadministration Rule,"

o Nuclear Criticality Safety Training, DG-3008 which became effective on January 27,1992. The new Issued: January 1993 requirements in 10 CFR 35.33(a)(2) and 35.21(b)(1)

Contact:

Charles W. Nilsen,301-492-3834 require the radiation safety officer (RSO) to: investigate overexposures and misadministrations; implement INFORMATION NOTICES PUBLISHED corrective actions, as necessary; retain records for 5 years; (December 15,1992-March 22,1993) and submit a report to NRC, including why the event occurred. The notice describes an instance of a Note that these are only summaries of information misadministration for which the licensee reported notices. If one of these publications appears relevant to inaccurate information to NRC, and the RSO failed to your licensed operation and you have not received it, we adequately investigate the incident.

recommend that you obtain the notice from the NRC contact listed here, or speak with the contact about its D. "12)cking of Radiography Exposure Devices," IN provisions.

93-5, January 14,1993 Technical Contacts:

A. " Release of Patients Treated with Temporary Gary Shear, Region (R)lli, implants," IN 92-84, 708-790-5620 December 17,1992 Charles Cain, RIV,817-860-8186 Technical

Contact:

Scott Moore, NMSS,301-504-2514 Robert L Ayres,301-504-3423 This notice (a) warns licensees that the locking This notice informs licensees of concerns about the mechanisms on certain industrial radiography exposure release of patients who have undergone either manual or devices can be locked with the sealed source in the remote afterloading brachytherapy procedures without exposed position; and (b) emphasizes the importance of positive assurance that all implant materials (sources) ensurmg that the source is secure in a shielded position have been removed. In one incident, a piece of cable before moving the device. The notice describes two cases f verexposure m which radiographers assumed that containing an iridium source from a high-dose, remote afterloader broke off and remained in a patient's body.

I eking of their exposure devices ensured that the sources The licensce's staff ignored an alarming wall-mounted were secured m a shielded position and did not properly area monitor and failed to perform the survey, using a use survey instruments or personal dosimetry. NRC hand-held instrument, required by 10 CFR 35.404 (a), to determmed that a majority of exposure devices can be determine if the source remained in the patient.

locked when the source is m a vanety of positions, rather Licensees are reminded of the need to perform the than only when the source pigtail is properly seated, with required surveys; to have emergency procedures, the source m the fully shielded position. The 10ckm, g including the availability of the necessary equipment and mechamsm is not an indicator that the source is fully staff; and to train personnel in both routine and

• offices will only be noted when mulii le contacts are from different emergency procedures.

offices. or contact is not from NMss 4

retracted and secured. Radiographers acknowledged to source material may wish to determine whether they NRC that they leave the drive cables and,in some cases, possess any material that is not covered by their specific the guide tube connected when moving the exposure license. If so, licensees may wish to review their radiation device.10 CFR Part 34 requires proper surveys and the safety procedures, to ensure appropriate compliance with use of an alarm rate-meter. It is also recommended that 10 CFR Parts 19, 20, 21, and 40.

radiographers disassemble the source guide tube, remove the drive controls, and install the safety plugs or covers H. " Portable Moisture-Density Gauge User before moving to another location.

Responsibilities during Field Operations,"

IN 93-18 E. " Classification of Transportation Emergencies,"IN March 10,1993 93-7, February 1,1993 Technical Contacts:

Technical

Contact:

nomas Young, RIII,708-790-5182 Kevin M. Ramsay,301-504-2534 Scott Moore, NMSS,301-504-2514 This notice informs licensees of a recent incident in which This notice reminds licensees of their responsibility to the classification of a transportation accident was maintam constant surveillance and security of portable confusing and misleading. A truck carrying fresh fuel was moisture-density gauges during field operations. Failure involved in an accident that resulted in a fire and to adequately secure gauges at construction sites has considerable property damage. The shipper declared a resulted in several incidents that have caused damage to

" Site Emergency" and responded in accordance with its gauges. Damage by heavy construction equipment is emergency plan. The " Site Emergency" designation frequently a cause of these accidents. NRC will take normally triggers actions by the licensee and offsite enforcement action, possibly leading to fines, m such response agencies near a fixed site. Licensees required to cases. Users must not leave the gauge unattended at any maintain an emergency plan may want to review their time at a temporary job site (10 CFR 20.207 (b)). After emergency classification procedures and consider the use of the device, they must properly secure it to prevent need to establish a separate classification for offsite damage, loss, or theft (10 CFR 20.207 (a)).

transportation accidents.

I.

" Slab Hopper Bulging," IN 93-19, F. " Dose Calibrator Quality Control," IN 93-10, March 17,1993 February 2,1993 Techmcal

Contact:

Marc Klasky,301-504-2504 Technical

Contact:

Patricia K. Holahan,301-504-2694 This notice warns fuel cycle licensees of possible bulging that may occur m slab hoppers. In October 1992, a This notice warns medical licensees about deficiencies licensee notified NRC that a visual inspection had en

@ng o a s pper, wM camch and irregularities that NRC inspectors identified in the performance and recording of dose calibrator quality slab thickness of the hopper to exceed the safe value control tests and emphasizes the importance of quality SPecified m the nuclear enticality safety analysis. The control procedures for equipment used to assay patient licensee found that all other slab hoppers had bulged and doses. He most frequent deficiencies have involved exceeded their design thicknesses and removed them constancy checks and linearity tests. nere have also been fr m service. In addition, the wall thickness of the hopper citations for failure to perform accuracy tests and originally f und to have bulged was thinner than specified, either because of its fabrication or because of determine geometric independence, among other problems. Medical personnel should be aware of the investigation has preh. extended use. He licensee's

'""*8

• minanly concluded that bulging applicable regulations (10 CFR 35.50) and any related license conditions, as well as Regulatory Guide 10.8, Rev.

ccurred because of metal fatigue, caused by extended 2, which provides model procedures. It is the ce and heat and powder expansion that occurs when se responsibility of the radiation safety officer and the U02 powder oxidizes while in the slab hoppers.

radiation safety committee to ensure that the necessary Licensees may wish to consider adding to the,r nuclear i

checks are carried out.

sa ety pmgrams tb following elements: specifications for design loadmgs, en,teria, and methods and acceptance G. " Clarification of 10 CFR 40.22, Small Quantities of criteria for slab hoppers; a quality assurance (QA)

Source Material,"IN 93-14' pr gram r slab hoppers; and a preventive maintenance February 18,1993 pmgram f r slab hoppers. In addition, when geometric Technical

Contact:

Marc Klasky,301-504-2504 e ntrolis used for criticality safety, the choice between geometric shapes should be based on the inherent abihty This notice warns source material licensees of possible f the equipment to retain its integrity, misapplication of the exemption in 10 CFR 40.22 (b). A NRC TRENDING PROGRAM FOR SAFE-recent inspection identified an instance in which a GUARDS EVENTS licensee possessed source material under both a general and a specific license and failed to provide required In October 1987, 10 CFR 73.71, " Reporting of coverage, in accordance with 10 CFR Parts 19,20, and 21, Safeguards Events," was revised for power reactor and for areas where the source material held under the Category I fuel cycle facilities.The revised rule included a general license was being used. Licensees that possess provision that requires that a copy of the safeguards event 5

log, previously kept onsite, be forwarded to NRC Institutions that have such sources should contact Nazir Headquartezs for analysis. This information allows NRC Khalil, at 803-725-5572. Information may also be faxed to identify and characterize generic and facility-specific to Mr. Khalil, at 803-725-8816.

precursors to certain safeguards events. These findings are provided to all reporting licensees and safeguards PROPOSED UNIFORM MANIFEST

)

RULEMAKING inspecto:s in the " Safeguards Event Analysis Report,"

published quarterly.

In a proposed rule that was published in the Fedeml Register on April 21,1992 (57 FR 14500), NRC sought to From these data, a number of reporting trends and improve the low-level waste (11W) manifest information indicators of precursors to equipment failure and human and reporting currently required in 10 CFR Parts 20 and error are emerging. The event logs and data analysis call

61. In attempting to accomplish this goal, the NRC staff attention to repetitive events, and licensees are finding and others recognized the multi-faceted needs that are that these events can be reduced through equipment or served by manifest information: specifically, the procedural changes. In many cases, these changes were transportation safety interests of the U.S. Department of developed and implemented, at nominal cost to the Transportation; the interests of NRC and Agreement facility. Solutions to common problems that some States in LLW disposal site performance assessment; the licensees have discovered are highlighted so other

" waste assignment" interests of the States or compacts licensees can prevent identical or similar events from charged with the responsibility of developing LLW occurnng.

disposal sites; and the interests of LLW disposal facility operators. Although many of the comments on the Information gleand from the logs and provided by NRC proposed rule addressed issues entirely within the inspectors and licenrees indicates that cost-effec'ive and purview of NRC, others were directed at features of the r

sound, long-term solutions to equipment failure and rule, manifest forms, or manifest instructions that human error are proving successfulin providing effective evolved as a result of the multi-faceted information security, while reducing these degradations. Moreover, needs.

hardware system event data are being used by some licensees to minimize operating costs by comparing costs The Imw. level Radioactive Waste Forum (an association e

of component repair, replacement, or system upgrade. In of representatives of States and compacts established to some cases, the data showed that for a particular facilitate implementation of the low-Level Radioactive hardware system, a system upgrade was more reliable and Waste Policy Amendments Act of 1985 and to promote less expensive to operate and maintain than the cost of the objectives of LLW regional compacts) has advocated continued repair and posting compensatory measures and supported the development of the " uniform that were required with the previous system.

manifest" rulemaking from its inception and had constituted a Manifest Tracking Working Group to The results of this attention have led to reduced system monitor development activities. Discussions between failures and human errors for door, perimeter detection members of the Working Group and some affected system, closed-circuit television camera, computer, parties in the private sector led to the suggestion that unsecured doors, and badge-related events. These types NRC sponsor an interactive meeting to clarify the of events had the highest number of occurrences purpose of the rule and further discuss concerns raised in recorded in the respective hardware system and human the comment letters.

error categories. Specific improvements that some g

licensees have chosen to make involve using a preventive discuss issues and comments on the proposed rule, the maintenance program to identify and correct component g

g g,

g weaknesses before equipment degradations occur; da 'N Mf d m k m@ m a increas%g security awareness through training, and forum to summarize significant issues raised by comment displaymg visual reminders of secunty responsibilities' letters, provide background discussion, and seek with the endorsement and support of the facility s comment from interested individuals. The meeting is management; and modifying or upgrading equipment tentatively scheduled to be held in the Washington, DC, with systems that are specifically designed to meet th area, on June 15,1993. A formal announcement with a needs of that facility (e.g., environment or population proposed agenda is expected to be made in the Federal considerations).

Register, soon. Those who submitted comments on the prop sed rule will be sent a copy of the Federal Register EXCESS PLUTONIUM-238/ BERYLLIUM mike For further mformat,on, contact William Lahs, at NEUTRON SOURCES 301-504-2569.

The Department of Energy (DOE)-Savannah River Field UPDATE ON RADIOPHARMACY Office is conducting a survey to learn the number of RULEMAKING plutonium-238/ beryllium neutron sources that licensees possess, but for which they have no programmatic use.

In June 1989, the American College of Nuclear This survey does not extend to plutonium-239/ beryllium Physicians (ACNP) and the Society of Nuclear Medicine neutron sources nor does it cover plutonium-238 alpha or (SNM) filed a petition for rulemaking to amend 10 CFR heat sources. This survey is for planning purposes and Part 35 to ".. correct regulatory incompatibility and may lead to DOE eventually accepting these sources.

permit the traditional practice of nuclear medicine and 6

HIGH-DOSE-RATE AFTERLOADING is unclear whether the manufacturer will be required to BRACHYTHERAPY MISADMINISTRATION AND recall the device, implement design modifications, and/or LOSS OF CONTROL OF A HIGH-ACTIVITY conduct field retrofits, to prevent recurrence of this IRIDIUM-192 SOURCE IN INDIANA, problem. Consequently, all patient treatments using this PENNSYLVANIA, ON NOVEMBER 16,1992

~

manufacturer's system must be viewed as having a high According to information received by NRC, an outpatient risk for similar failures. Although NRC has no recent being treated with an Omnitron Model 2000 Unit for reports of such failures of other HDR models, similar high-dose-rate (HDR) afterloading brachytherapy at the failures are possibic. For example, an mcident occurred m Indiana Regional Cancer Center (IRCC), Indiana, August 1988, where, because of an incomplete weld, the Pennsyhania, of Oncology Services Corporation, was end cap of a Nucletron MicroSelectron-HDR became returned to the nearby Scenery Hill Nursing Home, after detached from the source capsule and resulted in three treatment, with the source remaining in her body. The "t of seven Iridium-192 elements mside the capsule bem.g deposited in the head of the HDR and into the treatment took place on November 16, 1992, and the closed ended applicator. Because of the severe patient died on November 21,1992.The cause of death of this patient, as listed in the official autopsy report, is consequence associated with loss of control of one of

" Acute Radiational Exposure and Consequences these high-activity sources, users of all HDRs need to be Thereof" Until the source, approximately 4 curies of especially vigilant, m all their operations, to mtmmtze the iridium-192 (Ir-192), was removed from the nursing home effects of any machme or procedural errors that could lead to loss of control of the source.

after the patient's death, it subjected nursing home residents and staff, as well as visitors, to radiation NRC first became aware of the incident at Indiana, exposure. Radiation doses to the 94 members of the Pennsylvania, on December 1,1992, after the source was public associated with the event ranged between 40 mrem detected at the loading dock of a waste disposal facility in and 22 rem. NRC notified 77 of these individuals of their Warren, Ohio. Inspectors from Region I were f

estimated exposures and the possible health risks immediately dispatched to Indiana, Pennsylvania. After associated with this exposure.

an initial assessment of the incident, an NRC Incident Investigation Team (IIT) was formed and dispatched to During the therapy procedure, IRCC personnel the site on December 3,1992. Dr. Carl Paperiello, experienced difficulty with source placement in one of the Deputy Administrator of NRC's Region III office, led the patient's five treatment catheters. Subsequently, after team, which consisted of technical specialists from NRC the patient's death, investigators found that a short piece Headquarters and regional offices, an FDA inspector, of the cable containing the tridium source had broken off and an NRC physician consultant, Daniel F. Flynn, M.D.

and remained in one of the catheters inside the patient.

The IIT thoroughly reviewed the facts related to the The licensee did not believe that a wire breakage was a event, evaluated the exposures of all exposed individuals, i

credible event and placed complete reliance on the determined the probable causes, and made findings and source" safe" indication of the Omnitron 2000. Although recommendations for follow-on actions. In February a wall. mounted area monitor alarmed when the 1993, the IIT published a comprehensive report of its treatment was completed, the licensee's staff beheved investigation and findings, as NUREG-1480, entitled the device was emitting a false signal and chose to ignore

" Loss of an Iridium-192 Source and nerapy it, since the staff had a " safe" indication from the HDR Misadministration at Indiana Regional Cancer Center, afterloader. Also, nobody surveyed the patient, using a Indiana, Pennsylvania, on November 16,1992." nis hand-held survey instrument, to determine if all, or part, report is available from:

of the source remained in the patient.

The Superintendent of Documents A second HDR incident was reported on December 7, U.S. Government Printing Office 1992. A source again separated from the drive cable on an P.O. Box 37082 I

Omnitron Model 2000 Unit, during brachytherapy Washington, DC 20013-7082.

treatment of a patient, and lodged in the catheter, external to the patient. In this instance, the physicist The FDA conducted its own investigation of the event, detected the source separation during the treatment; he Performing audits of both the Edgerly, Louisiana, and Houston, Texas, Omnitron facilities. Both audits I

cut the catheter behind the source and immediately removed the patient from the treatment room. He indicated lack of proper procedures, component quality remaining portion of the catheter was then removed from assurance (OA) records, and tests. On the basis of these j

the patient, and both the catheter and patient were FDA audit findings at the Edgerly and Houston offices, j

scanned with a survey instrument, to confirm that no part the Texas Department of Health, assisted by the Houston of the source remained within either the catheter or pohce, embargoed the Omnitron 2000 HDR afterloader patient. In this incident, the staff reacted promptly and on January 12, 1993. To have the embargo lifted, appropriately; neither the patient nor the staff received Omnitron must complete the corrective actions needed any excessive unintended exposures.

to resolve the issues raised during the FDA audits.

To date, NRC has taken several actions related to this NRC and the U.S. Food and Drug Administration (FDA) event.

are conducting ongoing investigations of the cause of the failures associated with the Omnitron Model 2000 Unit.

1.

Bulletin 92-03, issued December 8th, informed Until complete failure analysis information is available, it licensees authorized to use the Omnitron 2000 HDR 8

1 J

nuclear pharmacy." The petitioners requested that the NRC's and Agreement States' knowledge of patient Commission amend its regulations to fully recognize the iacidents, and several major issues currently under NRC role of licensed nuclear pharmacists and physicians.

review, including: 1) effectiveness of NRC's oversight of Elements of the petition, involving strict adherence to the medical use of byproduct material: 2) followup of patients package insert, were addressed in the Interim Final R ule, subject to misadministrations; and 3) expansion of NRC's effective August 23,1990.This interim rule allowed, for a regulatory purview. The artic!cs allege that NRC was period of 3 years, specific departures from the package unaware of the extent of some misadministrations(and/or inserts, under the direction of a physician authorized failed to take appropriate actions in response) in which user, provided certain records were kept. Subsequently, deaths and serious injuries resulted. NRC and NRC and U.S. Food and Drug Administration (FDA)

Agreement State personnel analyzed the incidents staff reviewed records on departures and determined that identified in the Plain Dealer, to provide information on additional recordkeeping was unnecessary. NRC each incident that identified a patient, in addition to any published a rule, effective immediately, to eliminate followup action that NRC and the licensee took. This these recordkeeping requirements on October 2,1992.

analysis was provided to the Commission in NRC also plans to extend the termination date of the SECY-93-007, " Aspects of the National Medical Use Interim Final Rule to December 30,1994.

Program Related to Prevention of Misadministrations,"

and can be obtained from the Public Document Room.

The staff forwarded a proposed rule, SECY-93-050,

" Proposed Amendments on Preparation, Transfer, and Use of Byproduct Material for Medical Use," for After publication of these newspaper articles, the Commission consideration and approval on March 2, Commission was briefed, on four occasions, on various 1993, and briefed the Commission on the proposed aspects of the medical use program, as part of an overall amendments on March 9,1993.The majorfeatures of the review. On January 22,1993, the staff of the Office of proposed rule include: 1) allowing departures from Nuclear Material Safety and Safeguards and the Office of package inserts, as directed by physician authorized users; State Programs briefed the Commission on the " Aspects

2) creating the concept of an " authorized nuclear of the National Medical Use Program Related to pharmacist" and specifying training and experience Prevention of Misadministrations " On January 29,1993, requirements; 3) allowing physician authorized users and representatives of the Agreement States briefed the authorized nuclear pharmacists to use byproduct material Commission on their activities in the medical use area. An to compound radioactive drugs; 4) allowing the use of Incident Investigation Team (IIT) reviewed the byproduct material in research involving human subjects; circumstances surrounding the misadministration and and 5) allowing the use of radiolabeled biologics. In subsequent patient death involving a high-dose rate addition, the proposed rule contains other miscellaneous afterloader brachytherapy procedure in Indiana, PA. The l

amendments that include: 1) revising the definitions of IIT briefed the Commission on February 8,1993, on

" medical use" and " authorized user"; 2) requiring "Imss of Iridium-192 Source and Therapy

(

measurements of dosages of alpha-or beta-emitting Misadministration at Indiana Regional Cancer Center, radionuclides; 3) deleting nonradioactive reagent kits Indiana, Pa, November 16, 1992." Finally, on February l

from the regulations; 4) allowmg licensees to permit an 22,1993, the Advisory Committee on Medical Uses of authorized user or authorized nuclear pharmacist, who Isotopes (ACMUI) briefed the Commission on several meets certain requirements, to work without submitting a topics, including: the NRC response to the Plain Dealer license amendment, if NRC is notified: 5) deleting series; medical misadministrations; NRC regulatory provisions on visiting authorized users; 6) clarifying Purview; and brachytherapy regulation. In the future,the requirements that are applicable to a Type A specific Commission will be testifying before Congress on the licensee of broad scope; 7) recognizing additional medical use program.

professional society or board certifications; 8) changing the requirements for recentness of training; 9) requiring supervision by a physician authorized user, regarding The staff has also been developing a management plan preparation of byproduct material for medical use, and to for the reassessment of the medical use program. A provide comparable requirements regarding the

" Medical Issues" paper was prepared and discussed with supervisory responsibilities of authorized nuclear the ACMUI and representatives of the Agreement pharmacists;10)addingresponsibilities fortheRadiation States, in October 1992, and with NRC regional Safety Committee, regarding additional activities in the management, in November 1992. NRC currently has proposed Part 35 changes; and 11) adding a definition for several contracts, wnh national laboratories and private

" patient." If the Commission approves the proposed entities, to evaluate the risks associated with emerging rule, it will be published in the FederalRegister, for public medical technologies and the human error component of I

comment.

misadministrations. There will be two independent audits of NRC's medical use program, in addition to the staff medical management plan. '1 hey will include an internal REVIEW OF NRC'S MEDICAL USE PROGRAM review, to be conducted by an NRC senior managemant representative; and an external review of the program, to Recently, a series of newspaperarticles, dated December be conducted by an independent entity. Findings of the 13-20,1992, was published in the Cleveland Plain Dealer.

various studies and re,iews will be factored into the These articles raised both the question of the extent of management plan.

l 7

i

afterloader of the November 16,1992, incident and

~ Based on what is presently known about this incident, it is requested that they implement three actions: 1) clear that if proper radiation surveys of the patient had survey all patients, to be performed immediately been made, before releasing the patient from the facility, after ccmpleting each therapy treatment and before the consequences of this incident would have been largely removing the patient from the treatment room; 2) avoided. Although rare, the loss of control of one or more have procedures, staff, and equipment available for of these high-activity radiation sources has great potential prompt intervention, should the source not retract for causing injury or death to patients, workers, and into the shielded container at treatment end; and 3) members of the public. Hus, because the consequences have initial and semiannual training on procedures of such a loss of control are so severe, NRC and the FDA for both routine use of the afterloader and in case of have taken the previously described actions in a an emergency.

determined effort to minimize the possibility of a similar accident occurring again.

2.

Information Notice 92-84, issued December 17, 1992, informed all NRC medical licensees of this SAMPLING OF SIGNIFICANT EVENTS REPOR'ED TO NRC incident and reminded them of the requirements for positive assurance that all implanted sources are Event 1: Medical Therapy Misadministration Date removed before patients are released after treatment. It provided information similar to that in Notified: October 2,1992 Bulletin 92-03.

Licensee: St. Clares Riverside Medical Center, 3.

A new bulletin is be5g prepared that will be Denville, New Jersey addressed to all NRC licensees authorized to use On October 2,1992, the licensee notified NRC that a medium-and high-dose-rate afterloaders. This mis therapeutic misadm.. tration myolving the implant of bulletin will be similar to NRC Bulletin 92-03, but will include the additional requirement that the two indium-192 ribbons had occurred that day at its authorized user and the medical physicist or radiation facility. At 2:30 p.m. on October 1, a patient was safety officer be physically present during treatment.

tmplanted with 48.25 milhcunes of iridium-192 contained in two nylon nbbons inserted into catheters that extended 4.

Based on preliminary information from the IIT fr m the patient's abdomen into the common bile duct.

investigation, and separate inspections conducted by The procedure was scheduled to last 20 to 23 hours2.662037e-4 days <br />0.00639 hours <br />3.80291e-5 weeks <br />8.7515e-6 months <br />, Region I, NRC suspended Oncology Services durmg which a dose of 1500 to 2000 rads would be Corporation's (OSC's) license to operate six HDR dehvered to a colon tumor obstructing the common bile facilities in Pennsylvania, on January 20,1993. The duct. After implanting the indium-192 ribbons into the centers, all in Pennsylvania, are located in Exton, two catheters, the implant site was dressed and Harrisburg, Indiana, Pittsburgh, Stoneboro, and instructions were given to nursing personnel not to Lehighton.

change the dressing.These instructions were not detailed on the patient's chart. During the evening and early The license has been suspended because NRC's morning hours, the patient's dressings were changed investigation of OSC revealed a significant several times, because of drainage, and then reinforced breakdown in control of the licensed activities, with additional absorbent. At 4:15 a.m. on October 2, the where key personnel at several satellite facilities did nurse on duty noted that the dressing was displaced and not know the requirements of the NRC license, did replaced it. She also noticed that two ribbons were not have access to the pertinent license documents, displaced, but, not reah,zmg that the IR-192 seeds were m and had not been adequately trained in either the the ribbon, coiled them around her hand and taped them pertinent regulatory requirements or the to the patient s abdomen. A routme x-ray identified that procedures and instrumentation to be employed to the seeds were no longer implanted, and the coiled protect themselves and others from radiation ribbons were removed from the surface of the patient's n by a physician, at approximately 12:00 p.m. on exposure. These findings demonstrated a Oo r*

breakdown in the control of licensed activities at the corporate level, and is of the utmost regulatory ne licensee estimated that the patient received 1145 concern, because it contributed to a patient being rads to the targeted tumor site, between 172 and 1032 unknowingly exposed to a lethal amount of rads to the skin of the abdomen,19.9 rads to the liver and radiation, and other members of the general public small bowel,12.7 rads to the kidneys, 50.9 rads to the being exposed to unnecessary radiation.

colon, and 6.7 rads to the testes. The licensee estimated that the nurse who coiled the ribbons and taped them to 5.

OSC has appealed the suspension order to the the patient's abdomen received approximately 7.6 rads to Atomic Safety and Licensing Board (ASLB), and a her hands. The licensee expects no adverse effects as a hearing date is pending. However, the NRC staff has result of the misadministration, since this brachytherapy petitioned the ASLB for a 120-day delay in the treatment was a booster to the external beam dose that hearing, to allow the completion of three ongoing was yet to be administered.

criminal investigations against OSC.The corporation has opposed the request for a delay, and a decision on The misadministration was caused by: 1) failure of 1he this issue is pending before the ASLB.

radiation safety officer (RSO) to provide radiation safety 9

oversight during the brachytherapy procedure; and 2) that contributed to the misadministration. He licensee inadequate training of the nursing staff.

also intends to revise the treatment form, to make it more understandable.

The licensee's expanded training program familiarized personnel with the size and appearance of the radioactive A SAMPLING OF SIGNIFICANT ENFORCEMENT sources used in brachytherapy treatments at the ACTIONS AGAINSTMATERIAL LICENSEES licensee's facility. A manager will be responsible for ensuring that personnel on all shifts involved in the care One way to avoid regulatory problems is to be aware of and treatment of radiation therapy patients receive this enforcement problems others have faced.

training. The licensee named a new RSO because the current RSO was unable to devote sufficient time to the 1.

Consolidated Engineering Laboratories, radiation safety

program, because of other Pleasanton, California responsibilities. The licensee's actions also included: 1)

Supplement VI. EA 92-154 committing that a new RSO would be in place before another brachytherapy procedure is performed; 2)

A Notice of Violation and Proposed Imposition of Civil developing a nurses' procedure manual: 3) conducting Penalty was issued September 23,1992, to emphasize the formal in-service training in radiation safety with all importance of complying with NRC requirements, while nursing unit workers; and 4) requiring that a written working in areas under Federal jurisdiction. The action directive be initiated before ordering radioactive was based on the licensee's failures to: (1) use alarm material.

rate-meters; (2) maintain direct surveillance of radiographic operations; (3) survey a restricted area Event 2: MedicalHerapy Misadministration boundary; (4) post a high-radiation area; (5) provide adequate training; (6) have an NRC-approved quality Date Notified: December 2,1992 assurance program for shipping packages; and (7) register with NRC as a user of Type B shipping packages.

Licensee: Indiana University Medical Center, Indianapolis, Indiana 2.

District of Columbia General Hospital Washington, D.C.

A 31-month old patient being treated for a brain tumor Supplement VI, EA 92-027 was to receive two cobalt-60 teletherapy treatments of 150 rads each for a total dose of 300 rads, to reduce A Notice of Violation and Proposed Imposition of Civil swelling behind the patient's eye. The dosimetrist Penalty was issued March 4,1992, to emphasize the misinterpreted the written directive and thus made an importance of adequate management attention to, and incorrect dose calculation for 300 rads per treatment.The oversight of, the radiation safety program, so as to ensure i

patient was treated November 13 and 14,1992, with 300 that: (1) licensed activities are conducted safely and in rads per treatment for a total dose of 600 rads.

accordance with requirements; and (2) appropriate corrective measures are taken when problems exist at the Before the treatment, the authorized user physician facility. The action was based on violations involving the reviewed the treatment plan. After the treatments, a failures to: (1) provide required training to radiation medical physicist reviewed and approved the dose workers; (2) perform adequate review of personnel calculations. Both reviews overlooked the error. A radiation dose exposures in excess of administrative student technologist discovered the error during a limits; (3) hold all radioactive waste for 10 half-lives

]

monthly chart review, on December 2,1992.

before disposal as nonradioactive waste; (4) measure ambient dose rates quarterly, in brachytherapy source Both the patient's referring physician and guardian were storage areas; (5) conduct a quarterly physical inventory

)

informed of the misadministration. De treatment of all sealed sources; (6) test each dose calibrator for accomplished its intended purpose and the swelling was linearity over the range of its use; (7) test each dose reduced. He licensee reported that no adverse medical calibrator for geometry dependence for the vial effects were expected because of the additional radiation configuration; and (8) survey a radiopharmaceutical exposure.

patient's room for removable contamination, before The error was caused by the dosimetrist's error in the dose calculations, the physician's apparently inadequate 3.

Metals Evaluation and Testing, Inc.

review, and the physics staff's lack of verification of dose Oakland, California calculations, before the treatment began, ne doses Supplement VI, EA 92-105 normally used for this type of treatment are 300 rads per treatment, and this further contributed to the failure to A Notice of Violation and Proposed Imposition of Civil identify the error before the treatments occurred. There Penalty was issued August 21,1992, to emphasize the was also a problem with the legibility and format of the need for lasting and effective corrective action. The treatment plan.

action was based on a repeat violation invohing the failure to perform a thorough survey of a radiography The licensee has provided additional training to exposure device, to determine that the source had been treatment personnel, to eliminate the types of problems returned to its fully shielded position, after use.

10

i 4.

Midwest Inspection Services, Ltd.

imponance of ensuring that criticality control measures Oreen Bay, Wisconsin are maintained at the highest degree of effectiveness. nc Supplements IV and VI, EA 90-152 and EA 91-085 action was based on violations that collectively represent a breakdown in the licensee's nuclear criticality safety A Notice of Violation and Proposed Imposition of Civil program.

Penalty was issued October 11,1990, to emphasize the need for greater management control in all of the 7.

Westex Company licensee's activities. The action was based on violations Oxnard, California mvolving: (1) exposure of an mdividual m excess of 1.25 Supplement VI, EA 92-111 rems m a calendar quarter; (2) failure to report an exposure in excess of 10 CFR Part 20 limits; (3) failure to audit radiography personnel at the proper intervals; (4)

A Notice of Violation and Proposed Imposition of Civil failure to lock a sealed source assembly after completing a Penalty was issued July 30, 1992, to emphasize the radiographic operation; (5) failure to calibrate a survey importance of determining Federal requirements before instrument at the proper intervals; (6) failure to check Performing work in areas under Federal jurisdiction.The pocket dosimeters at the proper intervals; and (7) failure action was based on operatmg m Federal jurisdictions to properly mark or label a package or its outer packaging, without a license. The licensee admitted a violation for when transporting radioactive material. After numerous operating in offshore waters, without a valid NRC heense, interactions with NRC and others, on February 3,1992, but denied a violation for operating at Vandenberg Air the licensee indicated it intended to terminate its licensed Force Base, without a license. The licensee also activities and transfer all licensed material, which actions requested remittance of the proposed civil penalty. A were completed September 22,1992.

letter rescinding the civil penalty was issued November 2, 1992.

5.

Piping Specialists,Inc.

Kansas City, Missouri B. Severity Level III Violation, No Civil Penalty EA 91-136 and 92-054 1.

University of Connecticut Health Center An Order Suspending License (Effective Immediately) was issued October 17,1991.The action was based on the Farmington, Connecticut intentional falsification of NRC-required records, and Supplement IV, EA 92-189 false statements to NRC inspectors, as well as the use of unqualified individuals as radiographer's assistants. The A Notice of Violation was issued October 26,1992, based licensee requested a hearing on the Order on November on two violations that involved: (1) a radiation exposure, 20,1991. An Order Modifying Order Suspending License during the third calendar quarter of 1992, of 27.6 rem to (Effective Immediately) and Order Revoking License was the left forearm of a nuclear medicine technologist; and issued April 22,1992. The Order modified the previous (2) the technologist's failure to conduct an adequate order because NRC's Office of Investigations concluded radiological survey, to determine any contamination on that the Licensee's president was involved in the the wrists and forearms. A civil penalty was not issued violations, as well as other intentional acts, including because the licensee identified the violations, and failure to provide radiography workers with personnel because of the licensee's prompt and comprehensive monitoring devices. The decision became final December corrective actions, which included: (1) demonstration of 1,1992.

the proper " frisking" technique by the radiation safety officer; (2) establishment of a procedural requirement 6.

Siemens Power Corporation that the technical staff " frisk" at the end of each day and Richland, Washington keep a log of all results; (3) ordering a dedicated alarming Supplement VI, EA 92-163 ratemeter with a probe for frisking; and (4) restriction of l

the exposed technologist from further work in the hot A Notice of Violation and Proposed Imposition of Civil laboratory, for the remainder of the calendar quarter in l

Penalty was issued October 23,1992, to emphasize the which the overexposure took place.

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UNITED STATES FIRST CLASS Mall NUCLEAR REGULATORY COMMISSION POSTAGE AND FEES PAID WASHINGTON, D.C. 20555-0001 USNRC PERMIT NO. G-67 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE. $300 120555139531

_1_; 1 A 01C 01 C Y 19 A l US N90-0ADM DIV FOIA & PUBLICATIONS SVCS TPS-POR-NUREG P-211 WASHINGTON DC' 20555 l'

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