NMiSS Licensee Newsletter

0 U.S. Nuclear Office of Nuclear NUREG/BR-0117 

Regulatory Material Safety No. 00-2 

Commission and Safeguards June-July 2000

NRC REVIEW OF TOKAI-MURA NUCLEAR 

CRITICALITY ACCIDENT 

On September 30, 1999, a nuclear criticality 

accident occurred in a precipitation tank at the 

JCO Inc. facility located at Tokai-mura, Japan. 

The accident lasted about 20 hours and resulted in 

two worker fatalities and elevated radiation 

exposures to several hundred other workers and 

members of the public. [The exposure of members 

of the public is normally not expected for criti

cality accidents. However, the facility was located 

in a densely populated area, with the nearest 

residence only 100 meters (110 yards) from the 

area of the accident, and no actions were taken to 

evacuate people from the vicinity until about 

5 hours after the accident was initiated, because 

of emergency management problems and the lack 

of a facility emergency plan.] About 160 

local residents were evacuated from within 350 

meters (385 yards) of the site boundary, and 

about 310,000 people were sheltered within a 

10-kilometer (6.2 mile) radius of the site. Open 

news sources estimate the economic loss at over 

$93 million. The Japanese government revoked 

the business license of JCO Inc. and initiated a 

criminal investigation. Subsequent reports from 

the Japanese regulatory authorities indicated 

that the accident was an irradiation event

caused by direct radiation, and not a con

tamination event. There were no measurable 

environmental consequences. 

As a result of this accident, the President 

requested the U.S. Nuclear Regulatory 

Commission (NRC) to conduct a review of U.S. 

commercial facilities, to ensure that a similar 

accident would be unlikely to occur. NRC initiated 

steps to review the safety operations at U.S.

licensed and -certified fuel cycle facilities, 

determine the implications for NRC's oversight 

program, and issue a report addressing the lessons 

learned and implications. The proposed report

was made publicly available on April 24, 2000, as 

SECY-00-0085, "Review of the Tokai-mura 

Criticality Accident and Lessons Learned," and 

the staff briefed the Commission on the report 

during a public meeting on May 8, 2000. 

The direct cause of the criticality accident was the 

conduct of operations at the JCO facility. Briefly, 

the event involved the dissolution of over 16 

kilograms (36 lbs) of uranium oxide enriched to 

about 18.8% uranium-235 (U-235) in nitric acid, 

and their subsequent addition in 2.6-kilogram 

(5.7-1b) batches into an unfavorable geometry 

vessel (precipitation tank). This action resulted in 

a high concentration of U-235 that was 

sufficiently reflected and moderated for the 

geometry of the vessel to generate a supercritical 

power burst and sustain a quasi steady-state 

nuclear chain reaction for about 20 hours after the 

initial pulse. The actual processing operation 

violated the operating procedures that were 

required and approved by the regulatory authorities. 

Because there are indications that the company 

developed multiple sets of procedures to increase 

production efficiency without obtaining the approval 

of the regulatory authorities, the Government of 

Japan has initiated a criminal investigation. 

NRC review of the reports from the Japanese 

government indicates that there were three 

overarching root causes: (1) inadequate regulatory 

oversight; (2) lack of an appropriate safety 

culture; and (3) inadequate worker training. The 

licensing review incorrectly concluded that there 

was no possibility of a criticality accident. 

Consequently, no criticality accident alarm system 

was required nor installed and the facility was not 

included in the National Plan for the Prevention 

of Nuclear Disasters (e.g., the facility did not have 

an emergency plan). Furthermore, the regulatory 

authorities had not inspected the facility since 1992.

I

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NMSS Licensee Newsletter 

(June-July 2000) 

Contents

Page

1. NRC Review of Tokai-Mura Nuclear 

Criticality Accident ..................... 1 

2. Responsibilities of the Division of 

Industrial and Medical Nuclear Safety ..... 2

3. NRC Issues Final Rule Amending 

Well-Logging Regulations, 

10 CFR Part 39 ................... ..... 3

4. NRC to Hold Workshop on 

Decommissioning Issues ................. 4 

5. NRC Staff Forms Institutional Controls 

Working Group ........................ 5 

6. Cavalier Challenge ..................... 6 

7. Significant Enforcement Actions .......... 6 

8. Generic Communications Issued 

(March 1, 2000-June 30, 2000) ........... 7 

9. Selected Federal Register Notices 

(April 1, 2000-June 30, 2000) ............ 8 

10. Significant Events ..................... 10 

11. Correction ........................... 14 

The safety culture that developed at the facility 

was also inappropriate. Deviations from approved 

operating procedures began to occur several years 

before the company developed a second set of 

procedures to use to increase productivity. The 

Production and Quality Assurance departments, 

reviewed and approved the second set of 

procedures but the Safety Department did not. 

Within a year before the accident, about one-third 

of the facility staff was laid off. Of the three 

workers involved in the accident, two had never 

operated the 18.8 percent enriched uranium 

process, and the third worker had only several 

months of experience the last time it was run, 

about 3 years ago. There was no management 

action taken before the restart of the 18.8 percent 

enriched production run, to assure that the safety 

limits were properly disseminated to the workers 

through proper procedures, postings, and training. 

If the workers had been informed that certain 

actions could result in a criticality, this event, in

all likelihood, would not have occurred, because 

the workers would have understood the im

portance of adhering to the process safety limits. 

After the accident, NRC increased NRC resident 

inspector focus on the implementation of 

criticality safety programs at the high-enriched 

uranium facilities and gaseous diffusion plants. 

NRC also issued Information Notice 99-31, to 

alert licensees to the circumstances surrounding 

the accident, and evaluated the lessons learned as 

they became available from various sources. A 

review of the individual deficiencies identified as 

contributing to the accident or emergency 

response problems determined that each was 

adequately addressed by the current NRC 

oversight program. 

The staff concluded that the accident root causes 

were similar to causes of previous criticality 

accidents that have occurred in the world. The 

current safety program carried out at commercial 

U.S. fuel facilities makes a similar accident 

unlikely. Finally, emergency response plans 

provide defense-in-depth at U.S. facilities. 

(Contact: William S. Troskoski, 301-415-8076; 

e-mail: wmt@nrc.gov) 

RESPONSIBILITIES OF THE DIVISION OF 

INDUSTRIAL AND MEDICAL NUCLEAR 

SAFETY 

This is the first in a series of articles explaining 

the responsibilities of each of the Divisions within 

the Office of Nuclear Material Safety and 

Safeguards (NMSS). Other Divisions and groups 

within NMSS will be discussed in future NMSS 

Licensee Newsletters. 

NMSS is responsible for licensing, inspection, and 

environmental reviews for all activities regulated 

by the U.S. Nuclear Regulatory Commission 

(NRC), except operating power and all non-power

2

Comments, and suggestions you may have 

for information that is not currently being 

included, that might be helpful to licensees, 

should be sent to: 

E. Kraus 

NMSS Licensee Newsletter Editor 

Office of Nuclear Material Safety 

and Safeguards 

Two White Flint North, Mail Stop 8-A-23 

U.S. Nuclear Regulatory Commission 

Washington, D.C. 20555-0001
reactors. NMSS also performs safeguards 

technical review of non-reactor licensing activities, 

including export and import of special nuclear 

material. NMSS develops and implements NRC 

policy for the regulation of activities involving the 

use and handling of radioactive materials, such as: 

uranium recovery activities; fuel fabrication and 

development; medical, industrial, academic, and 

commercial uses of radioactive materials; 

safeguards activities; transportation of nuclear 

materials, including certification of transport 

containers; reactor spent fuel storage; safe 

management and disposal of low-level and 

high-level radioactive waste; and management of 

related decommissioning. 

The Division of Industrial and Medical Nuclear 

Safety (IMNS) is one of four divisions in NMSS. 

IMNS directs NRC's principal rulemaking and 

guidance development, licensing, inspection; event 

response, and regulatory activities for materials

as opposed to reactors-licensed under the 

Atomic Energy Act of 1954, as amended, to 

ensure safety and quality associated with the 

possession, processing, and handling of nuclear 

material. NRC's four Regional Offices are 

responsible for licensing and inspection of about 

5200 licenses in 18 States. Thirty-two other States, 

known as Agreement States, have assumed 

responsibility for nuclear materials and are 

responsible for about 16,000 licenses. IMNS 

provides central direction to NRC's regional 

programs and cooperates with the Agreement 

States on a national program for material safety. 

The direction of NRC's program includes 

oversight of health physics and radiation 

protection, nuclear safety review, and use of 

licensed materials in medicine, research, industry, 

and other purposes, with a focus on assuring 

safety and the effective and efficient delivery 

of regulatory services. IMNS is headed by 

Dr. Donald A. Cool, Director, and 

Dr. Josephine M. Piccone, Deputy Director. 

IMNS also plans, develops, monitors, and directs 

technical rulemakings and regulatory guides, for 

all NMSS activities, including those related to fuel 

cycle and materials, safeguards, transportation, 

decommissioning, the management of nuclear 

waste, and closure of uranium recovery facilities. 

The division manages the agency program for 

"exempt" use of radioactive material and for 

evaluation of sealed sources and devices. As part 

of the national program for materials safety, 

IMNS provides technical support for training of 

regional and Agreement State licensing and 

inspection staffs and provides technical support 

and guidance to the Regions on licensing, 

inspection, and enforcement activities and, on

request, to the Agreement States. The division 

identifies and takes action to control safety issues; 

responds to allegations; and directs NRC 

contingency and response operations dealing with 

accidents, events, and incidents under its 

responsibility. 

(Contact: Paul Goldberg, NMSS, 301-415-7842; 

e-mail: pfg@nrc.gov) 

NRC ISSUES FINAL RULE AMENDING 

WELL-LOGGING REGULATIONS, 10 CFR 

PART 39 

On April 17, 2000, the U.S. Nuclear Regulatory 

Commission (NRC) published a final rule, in the 

Federal Register (65 FR 20337), amending 10 CFR 

Part 39, "Licenses and Radiation Safety 

Requirements for Well Logging," its regulations 

governing licenses and radiation safety 

requirements for well logging. The final rule 

modifies NRC regulations dealing with: 

low-activity energy compensation sources (ECS'); 

tritium neutron generator target sources; specific 

abandonment procedures in case of an immediate 

threat; changes to requirements for inadvertent 

intrusion on an abandoned source; and the 

codification of an existing generic exemption. It 

also authorizes the removal of obsolete date, and 

the updating of regulations regarding consistency 

with the Commission's metrication policy. The 

Environmental Assessment conducted for this 

rulemaking demonstrated that there would be no 

significant impact on public health and safety nor 

the environment, resulting from this amendment. 

The final rule became effective on May 17, 2000. 

Several of the more significant changes are: 

1. The regulations were amended to recognize 

the use of a low-activity radioactive source, 

known as an ECS, contained within some 

well-logging tools used in well-logging, and to 

provide requirements governing its use. The 

ECS is used to calibrate the well-logging tool 

while the well is being drilled. This small 

radioactive source is used in addition to the 

larger radioactive source used to actually "log" 

a well. The ECS is typically less than 1.85 

MBq (50 microcuries), as compared with the 

normal 110 GBq-to 740-GBq (3-to 20-curie) 

sources used in well-logging. 10 CFR Part 39, 

originally promulgated in 1987, did not provide 

any specific provisions for these low-activity 

sources, and many of the requirements in 

Part 39, when applied to an ECS, are not 

appropriate nor necessary to protect public 

health and safety and the environment. 

Examples of requirements considered overly 

burdensome for licensees using ECS', include:

3
those addressing well abandonment (10 CFR 

39.15 and 39.77); leak-testing (10 CFR 39.35); 

design and performance criteria for sealed 

sources (10 CFR 39.41); and monitoring of 

sources lodged in a well (10 CFR 39.69). The 

rule change provided that only those sections 

dealing with leak-testing (a revised Section 

39.35 specifically addresses ECS); physical 

inventory (10 CFR 39.37); and records of 

material use (10 CFR 39.39), apply to the use 

of an ECS. 

The most significant change excludes an ECS 

from the costly procedures for well 

abandonment if only an ECS is lost within oil 

and gas wells, where a surface casing is used to 

protect fresh-water aquifers. However, if a 

surface casing is not used, the well

abandonment requirements would continue to 

apply. The rule establishes 3.7 MBq (100 

microcuries) as the limit for an ECS. The 

3.7-MBq (100-microcurie) limit should allow 

licensees flexibility in designing new sources of 

this kind while maintaining their radioactivity within an environmentally safe level. Although 

ECS sources will not be required to meet the 

requirements in 10 CFR 39.41, their sources 

will be required to be registered pursuant to 

10 CFR 32.210. Unless already otherwise 

exempted, ECS leak tests will need to be 

performed at a minimum of every 3 years. 

2. Tritium neutron generator target sources 

would be subject to the requirements of Part 

39, except for the sealed source design and 

performance criteria (10 CFR 39.41), and the 

well-abandonment procedures (10 CFR 39.15 

and 39.77), when a surface casing is used to 

protect fresh-water aquifers. The rule 

established 1110 GBq (30 curies) of tritium as 

the limit for a tritium neutron generator target 

source. The tritium neutron generator target 

sources will continue to be required to be 

registered pursuant to 10 CFR 32.210 and to 

meet applicable industry standards. 

3. Section 39.77 provides the requirements for 

notification and procedures for abandoning 

irretrievable well-logging sources. This section 

specifies that NRC must approve implemen

tation of abandonment procedures before 

abandonment. In some circumstances, such as 

high well pressures that could lead to fires or 

explosions, the delay required to notify NRC 

could cause an immediate threat to public 

health and safety. This section was revised to 

allow a licensee to use its judgment to 

abandon a well immediately, without prior 

NRC approval, if the licensee believed a delay

could cause such a non-radiological threat. In 

case of an immediate abandonment, the 

licensee is required to notify NRC and justify 

the need for an immediate abandonment after 

the fact. 

4. Section 39.15, which provides requirements 

for abandoning irretrievable sealed sources, 

has been revised to provide performance

based criteria for inadvertent intrusion on the 

source. This modification will allow licensees 

greater procedural latitude while continuing to 

ensure source integrity. For example, if a 

significant amount of drilling equipment must 

also be abandoned above the logging tool, the 

equipment itself may be deemed effective in 

preventing inadvertent intrusion on the source. 

5. Two revisions were made to 10 CFR 39.41, 

"Design and performance criteria for sealed 

sources." The first incorporated an existing 

generic exemption for sealed sources that 

were manufactured before 1989 and met older 

standards. The second added an optional 

acceptable standard by referencing oil-well 

logging requirements in the American 

National Standards Institute/Health Physics 

Society document N43.6-1997. 

(Contact: Bruce Carrico, NMSS, 301-415-7826, 

e-mail: jbc@nrc.gov) 

NRC TO HOLD WORKSHOP ON 

DECOMMISSIONING ISSUES 

On July 21, 1997, the U.S. Nuclear Regulatory 

Commission (NRC) published the final rule on 

"Radiological Criteria for License Termination" 

(the License Termination Rule or LTR) as 

Subpart E to 10 CFR Part 20. NRC regulations 

require that a materials licensee submit a 

Decommissioning Plan (DP) to support the 

decommissioning of its facility if it is required by 

license condition, or if the procedures and 

activities necessary to carry out the decom

missioning have not been approved by NRC and 

these procedures could increase the potential 

health and safety impacts on the workers or the 

public. NRC regulations also require that reactor 

licensees submit Post-shutdown Decommissioning 

Activities Reports and License Termination Plans 

(LTPs) to support the decommissioning of nuclear 

power facilities. 

As part of our continuing efforts to involve the 

regulated community, and other stakeholders, in 

our Decommissioning program, we will hold a 

workshop November 8-9, 2000, at the 

Commission's Headquarters in Rockville, 

Maryland. The workshop will be to provide a

4
forum for us to describe, and obtain feedback 

from, nuclear industry and non-industry 

stakeholders, on our process, and guidance for 

developing and evaluating DPs and LTPs. We will 

also describe, and receive feedback on, current 

issues associated with the decommissioning of 

nuclear facilities, and identify areas and strategies 

for improving the decommissioning process. 

Each day will feature presentations from NRC 

Headquarters and regional staffs and roundtable 

discussions on our process for reviewing DPs and 

LTPs, our expectations for the contents of DPs 

and LTPs, current policy and technical issues 

related to decommissioning, and key issues 

identified since promulgation of the LTR. When 

finalized, the agenda for the workshop will be 

posted on the NRC Website at: http://www. 

nrc.gov/NMSSIDWM/DECOMIdecomm.html 

The workshop will be open to the public and 

invited licensees, industry and non-industry 

stakeholders, and State regulators. Registration 

will be held from 7:45 to 8:30 a.m. on the first day 

of the workshop, November 8, 2000, at the 

entrance of the Two White Flint North 

Auditorium at 11545 Rockville Pike, Rockville, 

MD. There will not be any pre-registration, nor 

registration fee, and the workshop will run from 

8:30 a.m to 4:45 p.m. on both days. In addition, 

the workshop will be transcribed, and the 

transcripts, and any material presented at the 

workshop, will be posted on NRC's Website. 

(Contact: Nick Orlando, 301-415-6749, e-mail: 

dao@nrc.gov) 

NRC STAFF FORMS INSTITUTIONAL 

CONTROLS WORKING GROUP 

On July 21,1997, the U.S. Nuclear Regulatory 

Commission (NRC) published the final rule on 

"Radiological Criteria for License Termination" 

(the License Termination Rule) as Subpart E to 

10 CFR Part 20 (62 FR 39058). Subpart E 

establishes criteria at 10 CFR 20.1402 for the 

release of sites for unrestricted use, if the residual 

radioactivity that is distinguishable from 

background results in a total effective dose 

equivalent to an average member of a critical 

group that does not exceed 0.25 milliSievert per 

year (mSv/yr) (25 mrem/yr) and the residual 

radioactivity has been reduced to levels that are as 

low as is reasonably achievable (ALARA). 

Subpart E also establishes criteria at 10 CFR 

20.1403 for license termination with restrictions 

on future land use, as long as specific conditions 

are met, and criteria for license termination in

unusual situations where the site may exceed the 

0.25-mSv/yr (25-mrem/yr) limit, but would not be 

permitted to exceed 0.10 mSv/yr (10 mrem/yr) or 

0.50 mSv/yr (50 mrem/yr), under certain 

conditions. 10 CFR 20.1403(b) requires that 

licensees make provisions for legally enforceable 

institutional controls that provide reasonable 

assurance that the total effective dose equivalent 

from residual radioactivity distinguishable from 

background to the average member of the critical 

group will not exceed 0.25 mSv/yr (25 mrem/yr). 

Institutional controls include measures to control 

access to the site and minimize disturbances to 

engineered measures established by the licensee 

to control the residual radioactivity. They include 

administrative mechanisms (e.g., land use restric

tions) and may include, but not be limited to, 

physical controls (e.g., signs, markers, and fences). 

NRC staff has formed an Institutional Controls 

Working Group to explore the issues associated 

with these institutional controls and develop 

suggested policies and procedures for addressing 

the issues. The Working Group will continue the 

efforts undertaken by the NRC staff in developing 

the guidance in draft Regulatory Guide 

DG-4006, "Demonstrating Compliance with the 

Radiological Criteria for License Termination" 

(DG-4006). Note that the guidance summarized 

in DG-4006 will be incorporated in the "Standard 

Review Plan (SRP) for Decommissioning" the 

NRC staff is currently developing. 

The goals of the Working Group are to: 

1. Identify policy issues associated with 

institutional controls for which resolutions are 

required and develop possible resolutions; 

2. Develop model institutional control 

instruments, such as acceptable language for 

deed restrictions and financial assurance 

instruments; 

3. Develop various decommissioning scenarios 

and the institutional controls that would be 

applicable to each scenario; and, 

4. Develop/enhance current definitions in 10 

CFR 1400-1405 and develop guidance on 

institutional controls. 

The Working Group includes staff from the Office 

of Nuclear Material Safety and Safeguards and 

the Office of the General Counsel. Currently, the 

Working Group is reviewing the "Restricted 

Use/Alternate Criteria" section of the SRR 

(Contact: Dominick Orlando, 301-415-6749, 

e-mail: dao@nrc.gov)

5
CAVALIER CHALLENGE

The U.S. Nuclear Regulatory Commission (NRC) 

conducted a tabletop exercise, called Cavalier 

Challenge, in Lynchburg, Virginia, on May 24, 

2000. This was a joint Federal, State, and local 

exercise to examine and validate the concepts of 

operations for responding to an event involving external threats or weapons of mass destruction at 

a nuclear facility, which would raise both 

radiological safety and law enforcement issues. 

Cavalier Challenge was designed to provide a 

structured discussion forum, based on a scenario 

or set of conditions, for decision-makers or 

responders in a low-stress, no-fault environment. 

The exercise was intended to be both educational 

and developmental in that disconnects, 

perceptions, and procedures could be identified, 

examined, and corrected. 

The primary goals of Cavalier Challenge were to: 

(1) examine the relationships and understanding 

of participating organizations on how they would 

work together in response to an event with nuclear 

safety and law enforcement aspects; (2) foster a 

positive working relationship among responders to 

such an event; and (3) examine elements of the 

NRC/Federal Bureau of Investigation (FBI) 

concept of operations, incorporate lessons learned 

from this exercise, revise the concept, and 

distribute the concept for interim use to NRC, the 

FBI, and other responders. The exercise focused 

on three major activities: (1) examining the 

assessment and notification requirements and 

corresponding organizational interfaces of 

responders to an event with significant nuclear 

safety and law enforcement aspects; (2) examining 

the activation and deployment requirements of 

responders to the event; and (3) examining the 

response actions, command and control, and 

public interface requirements in response to 

the event. 

This exercise was noticed as a closed meeting. 

Approximately 100 people were invited to 

participate as players or observers. Participants 

included personnel from NRC, the FBI, U.S. 

Department of Energy, Federal Emergency 

Management Agency, licensees, and State and 

local decision-makers and responders. 

Representing NRC at the exercise were 

Commissioner Jeffrey Merrifield; Region II 

Administrator Luis A. Reyes; Incident Response 

Organization (IRO) Director Frank Congel; 

Nuclear Material Safety and Safeguards (NMSS) 

Division of Fuel Cycle Safety and Safeguards Director Michael Weber; and supporting technical 

staff from NMSS, IRO, and Region II. This 

exercise used a fictitious facility located in

Lynchburg, VA. BWX Technology agreed to play 

the licensee at the exercise, which made the 

exercise more realistic. Most attendees thought 

the exercise was a success. It provided attendees 

with the opportunity to meet each other face-to

face. Many thought that future exercises should 

focus more on State/local responses and Federal 

assistance to State/local authorities, with a reduced 

emphasis on higher-level coordination, such as 

lead Federal agency determination. It was also 

noted that the NRC/FBI interface in public affairs 

should be further developed in future exercises. 

(Contacts: Yen-Ju Chen, NMSS, 301-415-5615, 

e-mail: yjc@nrc.gov; Roberta Warren, NMSS, 

301-415-8044, e-mail: rsw@nrc.gov) 

SIGNIFICANT ENFORCEMENT ACTIONS 

Detailed information about these enforcement 

actions can be accessed via the U.S. Nuclear 

Regulatory Commission's (NRC's) homepage 

[http:I/www.nrc.gov/OE/]. Click on "Enforcement 

Actions." Cases are listed alphabetically. To access 

the complete enforcement action, click on the 

highlighted text after the name of the case. 

Medical 

Jersey City Medical Center, Jersey City, New 

Jersey EA 2000-014. A Notice of Violation for a 

Severity Level Ill violation was issued 

February 22, 2000. The action was based on the 

failure (on at least eight occasions) to secure the 

Nuclear Medicine Department hot laboratory 

where radioactive material was located. A civil 

penalty was not proposed because the licensee had 

not been the subject of an escalated enforcement 

action within the last 2 years, and credit was 

warranted for corrective actions that were 

considered prompt and comprehensive after NRC 

had identified the violations. 

Pocatello Regional Medical Center, Pocatello, 

Idaho EA 99-332. A Notice of Violation for a 

Severity Level Ill problem was issued on March 3, 

2000. The action was based on the failures: (1) to 

secure a generator from unauthorized removal as 

it was stored in an unrestricted area; (2) to limit 

the external dose from a generator temporarily 

stored in an unrestricted area to .02 Sv (2 

millirem) in any 1 hour; (3) to provide NRC with a 

written report within 30 days of an incident 

involving radiation levels in an unrestricted area 

that exceeded 10 times the limit contained in 

10 CFR 20.1301; and (4) to conduct adequate 

surveys to evaluate any associated radiological 

hazards caused by the incident. A civil penalty was 

not proposed because the facility had not been the 

subject of escalated enforcement action within the

6
last two inspections and credit was warranted for 

corrective action that was prompt and 

comprehensive. 

Radiography 

Maxim Technologies of New York, Inc., 

Mechanicsville, New York EA 2000-002. A 

Notice of Violation was issued January 10, 2000, 

for a Severity Level Ill violation. The action 

involved the performance of radiography in 

Vermont and Connecticut (States under NRC 

jurisdiction), from August through October 1999, 

by individuals who were not certified through a 

radiographer certification program by a certifying 

entity. A civil penalty was not proposed because 

the facility has not been the subject of an 

escalated enforcement action and credit was also 

given for corrective actions that were considered 

prompt and comprehensive. 

Well-Logging 

Allegheny Wireline Services, Weston, West 

Virginia EA 99-034 and 00-005. A Notice of 

Violation and Proposed Civil Penalty in the 

amount of $5500 was issued on February 8, 2000. 

The action was based on a Severity Level Ill 

problem comprised of two violations concerning 

deliberate falsification of well site radiation 

surveys, and a Severity Level Ill violation 

regarding the deliberate failure of the Radiation 

Safety Officer to provide adequate oversight 

concerning the completion of the well site surveys. 

No credit was warranted for the identification of 

the problem or the violation since NRC identified 

it. Credit was given for corrective actions that 

included additional training, revising procedures 

for conducting radiation surveys, increasing field 

audit frequencies, and disciplinary action against 

the individuals involved. 

Other 

Mallinckrodt, Inc., Maryland Heights, Missouri 

EA 99-322. A Notice of Violation was issued on 

January 11, 2000, for a Severity Level Ill violation. 

The violation involved the failure to notify NRC 

and the State agency after declaring an Alert. A 

civil penalty was not issued because the licensee 

had not been the subject of escalated enforcement 

action. Credit was also warranted for corrective 

action because the corrective actions were prompt 

and comprehensive. 

West Virginia University, Morgantown, West 

Virginia EA 99-300. A Notice of Violation and 

Proposed Imposition of Civil Penalty in the 

amount of $2750 was issued on February 4, 2000.

The action was based on a Severity Level Ill 

violation involving failures to secure from 

unauthorized removal, or limit access to, licensed 

material. The violations involve unsecured 

portable gauges and laboratories that were 

unlocked and unattended. The licensee had not 

been the subject of escalated action in the past 2 

years, but credit was not warranted for corrective 

actions, because the security violation had not 

been corrected after the licensee had identified it 

on three separate occasions before the November 

1999 inspection. 

Individual Actions 

Leonard Frye-IA 99-050. A Notice of Violation 

was issued on February 8, 2000, based on an 

investigation involving the deliberate failure of the 

Radiation Safety Officer at Allegheny Wireline 

Services to provide oversight sufficient to ensure 

the completion of radiation surveys and radiation 

survey records, as required. An Order was not 

issued because of the individual's forthrightness 

in the case, and the corrective actions taken by 

the licensee. 

(Contact: Sally Merchant, OE, 301-415-2747; 

e-mail: slm2@nrc.gov) 

GENERIC COMMUNICATIONS ISSUED 

(March 1, 2000-June 30, 2000) 

Note that these are only summaries of U.S. 

Nuclear Regulatory Commission generic 

communications. If one of these documents 

appears relevant to your needs and you have not 

received it, please call one of the technical 

contacts listed below. The Internet address for the 

U.S. Nuclear Regulatory Commission (NRC) 

library of generic communications is

www.nrc.gov/NRC/GENACT/GC/index.html. 

Please note that this address is case-sensitive and 

must be entered exactly as shown. 

Information Notices (INs) 

IN 2000-02, "Failure of Criticality Safety Control 

to Prevent Uranium Dioxide Powder Accumu

lation," was issued on February 22, 2000. This 

notice was issued to all fuel cycle conversion, 

enrichment, and fabrication facilities, to alert 

them to a problem recently noted with 

safety-significant level probes that are not 

self-checking. A level probe in a uranium dioxide 

powder hopper failed without indicating a failed 

condition. This allowed powder to accumulate 

and approach the criticality safety mass limit 

before discovery. 

Contact: Sheryl A. Burrows, NMSS, 

301-415-6667, e-mail: sab2@nrc.gov.

7
IN 2000-03, "High-Efficiency Particulate Air 

Filter Exceeds Mass Limit Before Reaching 

Expected Differential Pressure," was issued on 

February 22, 2000. This notice was issued to all 

fuel cycle conversion, enrichment, and fabrication 

facilities to alert them to a potentially significant 

nuclear criticality risk for high-efficiency 

particulate air filters that could accumulate special 

nuclear material beyond a safe mass. 

Contact: Dennis C. Morey, NMSS, 

301-415-6107, e-mail: dcm@nrc.gov. 

IN 2000-04, "1999 Enforcement Sanctions for 

Deliberate Violations of NRC Employee 

Protection Requirements," was issued on 

February 25, 2000. This notice was issued to all 

licensees to remind them of the sanctions that 

could result from deliberately violating NRC 

Employee Protection requirements. 

Contact: Michael Stein, OE, 301-415-1688, 

e-mail: mhs@nrc.gov. 

IN 2000-05, "Recent Medical Misadministrations 

Resulting from Inattention to Detail," was issued 

on March 6, 2000. This notice was issued to all 

medical licensees to remind addressees of the 

importance of following written directives and 

procedures, and the need to pay attention to 

detail, especially when verifying patient identity, 

programming treatment devices, and preparing 

treatment doses. 

Contacts: Susan L. Greene, NMSS, 

301-415-7843, e-mail: slg@nrc.gov. 

John D. Jones, RIII/DNMS, 630-829-9832, 

e-mail: jdj@nrc.gov. 

IN 2000-07, "National Institute for Occupational 

Safety and Health Respirator User Notice: 

Special Precautions for Using Certain 

Self-Contained Breathing Apparatus Air 

Cylinders" was issued on April 10, 2000. This 

notice was issued to all holders of operating 

licenses for nuclear power reactors, and 

non-power reactors, and all fuel cycle and 

material licensees required to have an 

NRC-approved emergency plan, to alert 

addressees to a recent Respirator User Notice, 

issued by the National Institute for Occupational 

Safety and Health, that recommends special 

attention and increased oversight and inspections 

for certain high-pressure aluminum seamless and 

aluminum composite hoop-wrapped cylinders 

made of aluminum alloy 6351 -T6. 

Contacts: William M. Troskoski, NMSS, 

301-415-8076, e-mail: wmt @ nrc.gov. 

James E. Wiggington, NRR, 301-415-1059, 

e-mail: jew2@nrc.gov.

Regulatory Issue Summaries (RIS) 

RIS 2000-09, "Standard Review Plan for 

Licensee Requests to Extend the Time Periods 

Established for Initiation of Decommissioning 

Activities," was issued on June 26, 2000. This 

summary was issued to all material licensees to 

inform them that NRC will now implement the 

standard review plan entitled, "Licensee Requests 

to Extend the Time Period Established for 

Initiation of Decommissioning Activities." 

Contact: John T Buckley, NMSS, 301-415-6607, 

e-mail: jtb@nrc.gov. 

RIS 2000-10, "Technical Information to Facilitate 

Public Access to the U.S. Nuclear Regulatory 

Commission's Agency-Wide Documents Access 

and Management System (ADAMS)," was issued 

on June 30, 2000. This summary was issued to all 

NRC licensees to provide individuals and 

organizations outside of NRC with information 

that will assist them in accessing, via the Internet, 

the publicly available portion of NRC's ADAMS. 

This RIS provides detailed technical (computing) 

information for use by network or system 

administrators in resolving certain types of 

problems; directions for locating updated 

materials on the Internet, as they become 

available; and directions for contacting NRC staff 

who will provide support on this endeavor. 

Contact: NRC Public Document Room, 

202-634-3273 or 800-397-4209, e-mail: 

pdr@nrc.gov. 

(General Contact: Mark A. Sitek, NMSS, 

301-415-5799, e-mail: mas3@nrc.gov) 

SELECTED FEDERAL REGISTER NOTICES 

(April 1 - June 30, 2000) 

NOTE: U.S. Nuclear Regulatory Commission 

(NRC) contacts may be reached by mail at the 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555-0001. 

FINAL RULES 

"Energy Compensation Sources for Well Logging 

and Other Regulatory Clarifications," 65 FR 

20337, April 17, 2000. 

Contact: Mark Haisfield, 301-415-6196, e-mail: 

mfh@nrc.gov. 

"List of Approved Spent Fuel Storage Casks: PSNA 

VSC-24 Revision," 65 FR 24623, April 27, 2000. 

Contact: Richard Milstein, (301) 415-8149, 

e-mail: rim@nrc.gov.

8
"List of Approved Spent Fuel Storage Casks: 

TN-68 Addition," 65 FR 24855, April 28, 2000. 

Contact: Gordon Gundersen, 301-415-6195, 

e-mail, gegl@nrc.gov. 

"List of Approved Spent Fuel Storage Casks: 

Holtec HI-STORM 100 Addition," 65 FR 25241, 

May 1, 2000. 

Contact: Merri Horn, 301-415-8126, e-mail 

mlhl@nrc.gov. 

"Revision of Fee Schedules; 100% Fee Recovery, 

FY 2000," 65 FR 36946, June 12, 2000. 

Contact: Glenda Jackson, 301-415-6057; e-mail: 

gcj@nrc.gov. 

List of Approved Spent Fuel Storage Casks: 

Standardized NUHOMS-24P and 

NUHOMS-52B Revision, 65 FR 38715, June 22, 

2000. 

Contact: Stephanie R Bush-Goddard, Ph.D., 

301-415-6257, e-mail: spb@nrc.gov. 

List of Approved Spent Fuel Storage Casks: 

VSC-24 Revision, 65 FR 38718, June 22, 2000. 

Contact: Gordon Gundersen, 301-415-6195, 

e-mail: gegl@nrc.gov. 

PROPOSED RULES 

"Interim Storage for Greater Than Class C 

Waste," 65 FR 37712, June 16, 2000. 

Contacts: Mark Haisfield, 301-415-6196, e-mail 

mfh@nrc.gov; Philip Brochman, 301-415-8592, 

e-mail: pgb@nrc.gov. 

List of Approved Spent Fuel Storage Casks: 

Standardized NUHOMS<Register> -24 and 

NUHOMS<Register> -52B Revision, June 22, 

2000. 

Contact: Stephanie R Bush-Goddard, Ph.D., 

301-415-6257, e-mail: spb@nrc.gov. 

List of Approved Spent Fuel Storage Casks: 

VSC-24 Revision, 65 FR 38795, June 22, 2000. 

Contact: Gordon Gundersen, 301-415-6195, 

e-mail: gegl@nrc.gov. 

OTHER NOTICES 

"Notice of Issuance and Availability of 

NUREG-1617, Standard Review Plan for 

Transportation Packages for Spent Nuclear Fuel," 

65 FR 20939, April 18, 2000. 

"Notice of Issuance and Availability of 

NUREG-1567, Standard Review Plan for Spent 

Fuel Dry Storage Facilities," 65 FR 20839, 

April 18, 2000.

"Metabolic Solutions: Denial of Petition for 

Rulemaking," 65 FR 21673, April 24, 2000. 

Contact: James Smith, 301-415-6459, e-mail: 

jas4@nrc.gov. 

"Notice of availability and request for comments: 

Consolidated Guidance about Materials Licenses: 

Program-Specific Guidance about Licenses for 

Special Nuclear Material of Less Than Critical 

Mass (NUREG-1556, Vol.17)," 65 FR 24514, 

April 26, 2000. 

Contact: Carrie Brown, 301-415-8092, e-mail: 

cxb@nrc.gov. 

"Standard Review Plan for the Review of a 

License Application for the Tank Waste 

Remediation System Privatization Project: Notice 

of Availability," 65 FR 25004, April 28, 2000. 

Contact: Michael Tokar, 301-415-7251, e-mail: 

mxt@nrc.gov. 

"Revision of the NRC Enforcement Policy," 65 

FR 25368, May 1, 2000. 

Contacts: Bill Borchardt, OE, 301-415-2741, 

e-mail: rwb@nrc.gov. 

Renee Pedersen, OE, 301-415-2741, e-mail: 

rmp@nrc.gov. 

"Notice of Termination of Section 274i Agreement 

with Louisiana," 65 FR 25508, May 2, 2000. 

Contact: Kevin Hsueh, 301-415-2598, e-mail: 

kph@nrc.gov. 

"United Plant Guard Workers of America; 

Receipt of Petition for Rulemaking 

(PRM-76-1)," 65FR 30018, May 10, 2000. 

Contact: David L. Meyer, ADM, 301-415-7162 

or toll-free: 1-800-368-5642: or e-mail: 

dlml@nrc.gov. 

"Memorandum of Understanding Between the 

Federal Bureau of Investigation and the Nuclear 

Regulatory Commission," 65 FR 31197, May 16, 

2000. 

Contact: John Davidson, 301-415-8130, e-mail: 

jjd@nrc.gov. 

"Notice of availability of NUREG/CR-6642, 

'Risk Analysis and Evaluation of Regulatory 

Options for Nuclear Byproduct Material 

Systems,' "65 FR 31620, May 18, 2000. 

Contact: Torre Taylor, 301-415-7900, e-mail: 

tmt@nrc.gov. 

"Notice of Availability of NUREG- 1700, 

'Standard Review Plan for Evaluating Nuclear 

Power Reactor License TerminatiOn Plans,' " 65 

FR 35675, June 5, 2000. 

"State of Oklahoma: NRC Staff Assessment of a 

Proposed Agreement Between the Nuclear

9
Regulatory Commission and the State of 

Oklahoma (1st printing)," 65 FR 36169, June 7, 

2000. 

Contact: Patricia M. Larkins, 301-415-2309, 

e-mail: pml@nrc.gov. 

"Notice of availability of NUREG-1712, 'Nuclear 

Byproduct Material Risk Review: Results of 

Survey of NRC and Agreement State Materials 

Licensing and Inspection Personnel,' "June 8, 

2000. 

Contact: Ms. Torre Taylor, 301-415-7900, 

e-mail: tmt@nrc.gov. 

"Nuclear Energy Institute; Receipt of Petition for 

Rulemaking (PRM-72-5)," 65 FR 36647, June 9, 

2000. 

Contact: David L. Meyer, 301-415-7162 or 

toll-free: 1-800-368-5642, e-mail: 

dlml@nrc.gov. 

"Notice of Availability and Request for Comments 

on draft NUREG-1556, Volume 18, 'Con

solidated Guidance about Materials Licenses: 

Program-Specific Guidance about Service 

Provider Licenses,' " 65 FR 36846, June 12, 2000. 

Contact: Carrie Brown, 301-415-8092, e-mail: 

cxb@nrc.gov. 

"Use of Screening Values to Demonstrate 

Compliance with the Final Rule on Radiological 

Criteria for License Termination," 65 FR 37186, 

June 13, 2000. 

Contact: Dr. Rateb (Boby) Abu-Eid, 

301-415-5811; fax: 301-415-5398; or e-mail: 

bae@nrc.gov. 

"Notice of Issuance and Availability of 

NUREG/CR-6672, 'Reexamination of Spent Fuel 

Shipment Risk Estimates,'" 65 FR 37186, June 

13, 2000. 

"NRC Staff Assessment of a Proposed Agreement 

Between the Nuclear Regulatory Commission and 

the State of Oklahoma (2nd printing)," 65 FR 

37437, June 14, 2000. 

Contact: Patricia M. Larkins, 301-415-2309, 

e-mail: pml@nrc.gov. 

"NRC Staff Assessment of a Proposed Agreement 

Between the Nuclear Regulatory Commission and 

the State of Oklahoma (3rd printing)," 65 FR 

38607, June 21, 2000. 

Contact: Patricia M. Larkins, 301-415-2309, 

e-mail: pml@nrc.gov. 

"NRC Staff Assessment of a Proposed Agreement 

Between the Nuclear Regulatory Commission and 

the State of Oklahoma (4th printing)," 65 FR

39966, June 28, 2000. 

Contact: Patricia M. Larkins, 301-415-2309, 

e-mail: pml@nrc.gov. 

Natural Resources Defense Council; Receipt of 

Petition for Rulemaking, 65 FR 40548, June 30, 

2000. 

Contact: David L. Meyer, 301-415-7162 or 

toll-free: 1-800-368-5642 or e-mail: 

dlml@nrc.gov. 

"Governors' Designees Receiving Advance 

Notification of Transportation of Nuclear Waste, 

65 FR 40704, June 30, 2000. 

Contact: Spiros Droggitis, 301-415-2367, 

e-mail: scd@nrc.gov. 

(General Contact: Paul Goldberg, 

301-415-7842, e-mail: pfg@nrc.gov) 

SIGNIFICANT EVENTS 

Event 1: Sodium Iodide Radiopharmaceutical 

Misadministration at Hermann Hospital in 

Houston, Texas 

Date and Place-August 4, 1999; Hermann 

Hospital; Houston, Texas. 

Nature and Probable Consequences-On August 5, 

1999, the licensee Radiation Safety Officer 

provided written notification to the Texas 

Department of Health, Bureau of Radiation 

Control (BRC) of a medical misadministration 

involving the administration of iodine-131 (1-131) 

to the wrong patient. The licensee reported that 

two female out-patients (who both spoke English 

as a second language) were involved in the error, 

which occurred on the morning of August 4, 1999. 

Patient A (for whom the therapeutic dose of 

I-131 was intended) was approximately 55 years 

old; Patient B (who inadvertently received the 

1- 131 dose) was approximately 64 years old. 

Patient B had completed a scheduled bone density 

scan and was still in the nuclear medicine 

department. At that time, the technologist 

misidentified her as the patient who was to receive 

a therapeutic dose of I-131. Patient B was then 

administered 1.01 gigabecquerels (27.3 milicuries) 

of 1-131 at approximately 10:40 a.m. (CDT) and 

was sent home. Patient A was later observed to 

still be in the waiting room needing to be 

administered the 1-131. At this time, the licensee 

realized that the misadministration had occurred. 

Patient A was then administered the prescribed 

dose of 1-131 and returned home. 

At approximately 4:00 p.m (CDT) on August 4, 

1999, the Radiation Safety Officer, the Chief of 

the Nuclear Medicine Department and the

10
Nuclear Pharmacy Manager were dispatched to 

Patient B's home to discuss the misadministration 

with her and her husband. With the patient's 

consent, the Nuclear Medicine Physician initiated 

the administration of supersaturated potassium 

iodide (1 milliliter three times per day) and 

furosemide (lasix) at an initial dose of 

40 milligrams per day, to reduce the patient's 

radiation exposure caused by the error. The 

administrations were completed at approxi

mately 5:20 p.m. (CDT). The misadministered 

patient received a radiation dose to the 

thyroid of approximately 22,000 centiGray (rad). 

This radiation dose left the patient with an 85 

percent chance of functional loss of her thyroid, 

and replacement thryroid hormone will be 

required indefinitely. 

Actions Take to Prevent Recurrence 

Licensee-The licensee changed its procedures 

for all outpatient therapeutic treatments that 

involve radioactive material. The patient 

information sheet form was changed to ask 

questions like: "What is your name?" "What 

is your date of birth?" ....instead of having 

questions requiring "yes" or "no" answers. The 

licensee will also ask outpatients to show a picture 

form of identification as a mean of properly 

identifying a person. For pediatric patients, the 

parent or guardian must confirm the identification 

of the patient. 

State Agency-BRC staff conducted an 

investigation and agreed with the licensee's 

findings and believes that the licensee's corrective 

actions are adequate to prevent recurrence. 

Event 2: High Dose-Rate Remote Afterloader 

Misadministration at Queen's Medical Center in 

Honolulu, Hawaii. 

Date and Place-October 27, 1999; Queen's 

Medical Center; Honolulu, Hawaii. 

Nature and Probable Consequences-On 

October 28, 1999, a medical physicist representing 

the licensee reported a medical 

misadministration, which occurred on the day 

before, involving a single fractional treatment. 

The treatment was performed using a Nucletron 

high-dose-rate (HDR) remote afterloading device 

loaded with an iridium-192 source of 

approximately 252 gigabecquerel (6.8 curies). The 

licensee categorized the treatment as a 

misadministration because the patient received an 

unintended dose of 380 centiGray (rad) to the 

right nasal cavity. This treatment was the first of 

four scheduled fractions intended to deliver a total

dose of 1520 centiGray (rad) to a specified 

location in the nasopharynx. 

Initial simulation radiographs taken to determine 

the appropriate dwell positions indicated a 

standard distal dwell position of 995 millimeters 

(mm) was appropriate. After patient setup and 

insertion of the treatment catheter, a position 

simulator tool was used to verify the distal dwell 

position of the catheter. The position simulator, as 

used by a staff dosimetrist, indicated a distal dwell 

position of 950 mm and a repeat measurement 

gave the same value. During both measurements, 

the dosimetrist felt resistance when moving the 

slide pointer on the tool. Although the measured 

distal dwell position was different from that 

expected, the measured 950-mm value was 

believed to be correct because the dosimetrist was 

able to reproduce the measurement. In addition, 

because catheters were sometimes customized at 

the facility, by cutting them to shorter lengths 

when needed, the staff did not initially question 

the measured distance. None of the dwell position 

measurements was independently checked by 

other members of the radiation oncology staff. 

Treatment was subsequently initiated. 

The following day, a different dosimetrist 

reviewed the case before delivering the second 

treatment fraction. Noting the recorded 950-mm 

distal dwell position as somewhat unusual, in that 

it was shorter than expected, he performed further 

checks. Using the position simulator toll, the 

dosimetrist noticed the measuring cable was 

difficult to move past the 950-mm position. 

However, the dosimetrist was able to extend the 

position simulator cable to the expected 955-mm 

position. As a further check, the dosimetrist set 

the position simulator to the 950-mm position and 

took new radiographic films of the patient's 

nasopharynx, which showed the distal dwell 

dummy source displaced 45 mm from the position 

intended. The dosimetrist performed a final 

verification of the actual distal dwell position 

using the Nucletron "Special Mode" and dummy 

source wire. (With this selection, a dummy source 

wire is run through the catheter, using the 

Nucletron unit, and the source travel is measured 

automatically.) When this mode of operation was 

used, the measured distal dwell position was again 

determined to be 995 mm. 

Actions Taken To Prevent Recurrence 

Licensee-To prevent similar problems the 

licensee initiated the following corrective actions: 

(1) the storage cabinet for HDR catheters was 

labeled to specify the distal dwell position 

associated with each transfer tube, to remind the 

operator to enter the correct value; (2) a new,

11
replacement position simulator, previously 

ordered by the licensee, was received and placed 

into operation; and (3) there was a requirement 

for a second member of the physics staff to 

double-check the measurement process and data 

involving any use of a position simulator. A 

worksheet used during the physics checks has 

been modified to document the presence of 

both individuals. 

NRC-U.S. Nuclear Regulatory Commission 

(NRC) staff from the Region IV office conducted 

an inspection to review the circumstances 

associated with the misadministration. This case is 

still under review by an NRC medical consultant. 

Event 3: Gamma Stereotactic Radiosurgery 

(Gamma Knife) Misadministration at Healthsouth 

Doctor's Hospital, Inc., Coral Gables, Florida. 

Nature and Probable Consequences-The Florida 

Bureau of Radiation control (BRC) reported to 

the U.S. Nuclear Regulatory Commission (NRC) 

Headquarters Operations Center that a medical 

misadministration had occurred at the licensee's 

facility on January 25, 2000. A patient diagnosed 

with metastatic lung disease with up to 80 brain 

lesions identified was being treated with a 

stereotactic radiosurgery procedure using the 

Leksell Gamma System, Model 23016 (gamma 

knife). The patient was receiving her fourth of five 

treatments when the misadministration occurred. 

Each treatment consisted of 16 lesions for 

irradiation. A treatment plan was developed to 

deliver to each lesion a minimum peripheral dose 

of 12 Gray (1200 rad). The misadministration 

occurred when the patient received a 12-Gray 

(1200-rad) peripheral dose to lesion site 16 (MRI 

z coordinates 70.7 mm) instead of lesion site 47 

(MRI z coordinates 85.0 mm). Site 16 was 

previously treated on December 28, 1999, with the 

same dose. Lesion site 16 was located 6-mm 

superior, from site 47 in the z plane. The MRI 

slices are 3-mm slices in the z direction. The MRI 

slice at z coordinate 67.9 did not resolve the lesion 

at site 47. The radiation safety officer (RSO) 

indicated that the incorrect MRI was displayed on 

the computer screen (z-70.7 mm instead of 65.0 

mm) and the treatment plan was calculated at this 

incorrect coordinate. The RSO discovered this 

error on January 28, 2000, during the licensee's 

routine quality assurance review of the treatment, 

and reported it to the BRC that same date. The 

BRC conducted an on-site investigation on 

February 2, 2000, which included a review of the 

treatment plans, the written directive, physician

approval procedures, and a reenactment of a 

treatment plan for the remaining untreated sites. 

The event was determined to be caused by human

error when the wrong treatment site was selected 

in the computer. There was no malfunction of the 

gamma knife or computer equipment. 

Actions Taken to Prevent Recurrence 

Licensee-The licensee did not identify any 

corrective actions nor changes in quality 

management procedures, that would have 

prevented this type of human error. The licensee 

will pay closer attention to detail. 

State Agency-State investigation found no 

violations of the license nor regulations. The 

licensee's quality assurance program found the 

error. The licensee had the wrong site set in the 

computer when the procedure was performed. 

The State did not identify any corrective actions or 

changes that would have prevented this event. 

NRC-The Office of Nuclear Material Safety and 

Safeguards is in the process of developing an 

Information Notice to address gamma knife 

misadministrations caused by human error. 

Event 4: Significant extremity overexposure of 

radiation workers at Mallinckrodt Medical, Inc., 

in Maryland Heights, Missouri. 

Date and Place-March 31, 2000; Mallinckrodt 

Medical, Inc.; Maryland Heights, Missouri. 

Nature and Probable Consequences-The 

licensee-a radiopharmaceutical manufacturing 

facility-notified the U.S. Nuclear Regulatory 

Commission (NRC) of an event involving an 

employee directly handling an unshielded 

molybdenum-99 (Mo-99) technetium-99 

generator column. The column contained 700 

gigabecquerels (19 curies) (Mo-99) and 300 

gigabecquerels (8 curies) of technetium-99m 

(Tc-99m). Event reenactments determined that 

the individual may have held the column using his 

thumb and index finger of his left hand for as long 

as 50 seconds while attempting to correct 

alignment problems with the inlet and outlet 

needles. The individual wore a ring badge on the 

right hand to measure extremity dose, and this 

monitor read 0.057 sieverts (5.7 rems). 

Calculations indicated that the dose to the 

individual's thumb and index finger of the left 

hand may be as much as 25-gray (2500-rad) 

shallow dose equivalent. 

The licensee's investigation into the event 

identified two additional exposure situations 

involving 13 other individuals in other areas of 

the facility. 

One situation involved the hand-labeling of 

product vials that contained approximately 740

12
megabecquerels (20 millicuries) or iridium-ll, an 

accelerator-produced radioactive material. Ten 

individuals, over the period between 1995 and 

1999, inclusive, held the product vials in their left 

hands, with the index fingers on the tops of the 

vials and their thumbs on the bottoms, in close 

proximity to the radioactive material, and applied 

the labels with their right hands. The individuals 

all wore their extremity monitors on their right 

hands. Licensee calculations determined that the 

individuals involved in this practice received 

between 0.5- and 6-sievert (50- and 600-rem) 

shallow dose equivalents during calendar years 

1995 through 1999. Several individuals received 

exposures in excess of 0.5 sievert (50 rems) in 

multiple years. 

The other situation involved three additional 

individuals who worked in one of the licensee's 

product testing-laboratory. While performing their 

duties in this laboratory, the individuals removed 

aliquots of radioactive material for testing from 

product vials, using unshielded syringes, and in 

some instances, while holding the unshielded vials 

in their hands. These individuals received between 

0.7- and 1.0-sievert (70- and 100-rem) shallow 

dose equivalents to their hands and fingers during 

calendar years 1997 and 1999. Again, some of the 

individuals received exposures in excess of 0.5 

sievert (50 rems) in more than 1 year. 

The licensee believed that the exposures recorded 

by the extremity monitors were the "doses of 

record," and did not recognize the significant 

difference between the recorded dose and the 

actual dose to the finger tips when handling 

unshielded vials and syringes of radioactive 

material. This contributed to the licensee not 

being fully aware of the extent of inadequate 

radiation-handling practices. The extremity 

monitor results for the individuals involved in 

these last two situations did not provide any 

indications that they were receiving doses in 

excess of NRC regulatory limits. 

Actions Taken to Prevent Recurrence 

Licensee-Corrective actions include procedure 

modification and conducting training sessions with 

employees to review all applicable procedures. 

The licensee hired a contractor to perform a 

Hazard/Barrier-Risk Assessment to ensure that 

the true root causes of this event are identified. 

NRC-On July 18, 2000, NRC issued information 

Notice 00-10, "Recent Events Resulting in 

Extremity Exposures Exceeding Regulatory 

Limits." (This Information Notice alerted 

licensees to recent events that resulted in

personnel receiving occupational extremity doses 

in excess of the 0.5-sievert (50-rem) shallow dose 

equivalent limits specified in 10 CFR 

20.1201(a)(2)(ii). 

Event 5: Gamma Stereotactic Radiosurgery 

(Gamma Knife) Misadministration at University 

of Maryland at Baltimore Hospital, 

Baltimore, Maryland. 

Date and Place-April 20, 2000; University of 

Maryland at Baltimore Hospital, 

Baltimore, Maryland. 

Nature and Probable Consequences-The licensee 

reported a medical misadministration involving a 

52-year-old female patient who was scheduled to 

receive gamma knife therapy to the 50 percent 

isodese line, for treatment of Pituitary Adenoma. 

The patient received 1260 centiGray (rad) to an 

unintended site, with a volume of approximately 

0.18 cubic centimeter (cm) at the base of the 

frontal lobe. The unintended site was 

approximately 4.2 centimeters (cm) from the 

intended site. The Leksell Gamma System gamma 

knife (model 23016) uses 201 sealed Co-60 

sources of 1.1 Tbq (30 Ci) each for the radiation 

treatment of human patients. The medical 

directive for this treatment was defined as 1800 

cGy (rad) administered over six administrations. 

The misadministration occurred during the first 

administration. The unintended site would have 

received approximately 160 cGy (rad) during the 

first fraction, had the first fraction been completed 

as prescribed. The treatment planning for the 

patient was uneventful and was prepared and 

reviewed by a hospital gamma knife team of a 

radiation oncologist, a neurosurgeon, and a 

medical physicist. It appears from preliminary 

interviews that when two of the team members 

were adjusting the coordinates on the device's 

stereotactic frame, the Y and Z coordinates were 

reversed. The frame adjustment is supposed to be 

checked for accuracy by a nurse and the medical 

physicist. Normally, the coordinates are read out 

in a specific order. The licensee indicated that the 

order might have been reversed because of a 

specific frame orientation problem that occurs 

approximately once in every 20 treatments. When 

the licenses started to set up for the second 

administration, the error was noted. The 

treatment plan was reevaluated to include some 

partial dose to the tumor from the first 

administration, and the treatment was completed 

in seven administrations instead of six. The 

patient and the referring physician were notified 

of this misadministration on the same day the 

event occurred. The licensee is reviewing previous 

medical files to ensure that the switching of 

coordinates has not occurred before without a

13
misadministration being identified. The root 

cause of this event appears to be human errors 

during the setting and verification of 

patient-positioning parameters. 

Actions Taken to Prevent Recurrence 

Licensee-The licensee has developed and 

implemented an additional procedure that 

requires more attention and better confirmation 

of coordinate placement on the frame. 

State Agency-The additional procedure 

developed by the licensee is under review by the 

Maryland Radiological Health Program (RHP). 

This event is still under investigation by RHP. 

NRC-The Office of Nuclear Material Safety and 

Safeguards is in the process of developing an 

Information Notice to address gamma knife 

misadministrations caused by human error. 

Event 6: Gamma Stereotactic Radiosurgery 

(Gamma Knife) Misadministration at Healthsouth 

Medical Center, Birmingham, Alabama 

Date and Place-April 12, 2000; Healthsouth 

Medical Center; Birmingham, Alabama. 

Nature and Probable Consequences-The licensee 

reported a misadministration where the gamma 

knife was set up incorrectly and delivered the dose 

to the wrong location of a patient's brain. A 

radiosurgery treatment was to be delivered to the 

Left Trigeminal Nerve of a 51-year-old woman, 

using the Leksell Gamma System (model 23016) 

gamma stereotactic radiosurgical unit (gamma 

knife) containing 243.9 Tbq (6592.8 Ci) (activity of 

8/1/95) of Co-60. On the same date, a 75-year-old 

man was admitted for the identical treatment. 

During the signature phase of plan approval, the 

dose-delivery sheet of the 75-year-old man's 

treatment protocol was inadvertently transposed 

with that of the 51-year-old woman's treatment 

protocol. As a result, the 51-year-old woman was 

treated with the radiosurgery parameters intended 

for the 75-year- old man. This resulted in an 

8000-cGy (rad) dose to the wrong treatment site 

of the patient's Left Trigeminal Nerve. The

intended prescription dose to the treatment site 

was 8000 cGy (rad) at the 50 percent isodese line. 

The actual dose delivered to the intended 

treatment site was 20 cGy (rad) (maximum) as 

calculated by the licensee. A dose of 8000 cGy 

(rad) was delivered to a volume 88.6-cubic 

millimeter volume inside the skull of the woman, 

but outside of the intended treatment site. The 

misadministration was noted immediately after 

the delivery of the dose. The patient was notified 

verbally, within 24 hours. On April 20, 2000, the 

patient returned to the medical center and 

received treatment to the intended treatment site. 

Actions Taken to Prevent Recurrence 

Licensee-As a result of the misadministration, 

the licensee took immediate action to prevent the 

mixing of patient treatment protocol 

documentation. Each page of the treatment 

protocol was modified to contain a unique name 

and time stamp, which will be reviewed by the 

Radiation Oncologist or Medical physicist as 

evidenced by initialing each page of the protocol 

near this stamp), before the delivery of the 

radiosurgery treatment. 

State Agency-the State staff conducted an 

investigation and agreed with the licensee's 

findings and believes that the licensee's proposal 

is adequate to prevent recurrence. 

NRC-NMSS is in the process of developing an 

information Notice to address gamma knife 

misadministrations caused by human error. 

(Contact: Roberto Torres, 301-415-8112; e-mail: 

rjt@nrc.gov. 

CORRECTION 

In the March-April issue of the NMSS Licensee 

Newsletter (No. 00-01), the article entitled 

"New Source Calibration and Dosimetry for 

Palladium-103 and Interstitial Sources," contained 

errors in the conversion of gray units (Gy) to rad 

units. The correct figures are: 115 Gy (11,5000 

rad); 124 Gy (12,4000 rad); and 135 Gy 

(13,500 rad).

14
UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

WASHINGTON, D.C. 20555-0001

years