U.S. Nuclear 

Regulatory 

Commission

Office of Nuclear 

Material Safety

and Safeguards

NUREG/BR-0117

No. 01-3

September-October 2001

The short-term approach is to be completed by the 

end of 2001. The elements of this approach are to:

a. Risk-prioritize the existing inspection 

procedure subsection, using available risk/

consequence information and an expert 

panel approach.

b. Apply inspection resources 

commensurate with risk and the 

performance history of the inspected entity. 

(New licensees or fabricators will initially 

get more in-depth inspections until a 

performance history is established.) 

The long-term approach is conceptualized to more 

closely align with the NRR risk- informed inspection 

approach described in the reactor oversight process. 

The elements of the long-term approach are to:

a. Complete a Probabilistic Risk 

Assessment (PRA) for ISFSIs. A PRA is 

currently being prepared by the Office of 

Nuclear Regulatory Research. An initial 

product from the PRA is predicted for fiscal 

year 2002. 

b. Using the PRA results, explore the 

possibility of adopting an oversight program 

that is based on risk and performance 

indicators, in a manner similar to the 

NRR program. Also, evaluate ISFSI 

inspection resources using the new process. 

Additionally, evaluate a significance 

determination process for assessing the 

significance of inspection findings. 

NMSS Licensee Newsletter

(September - October 2001)

Contents Page

1. Risk-Informing and Performance-Basing 

Inspection Procedures ............................... 1

2. Publication of NUREG-1717, “Systematic 

Radiological Assessment of Exemptions 

for Source and Byproduct Materials” ........ 2

3. Selected Federal Register Notices 

(June 1, 2001 - August 31, 2001) .............. 3

4. Generic Communications Issued 

(May 1, 2001 - August 31, 2001) ............... 4

5. Significant Enforcement Actions ............... 5

6. Significant Events ...................................... 8

RISK-INFORMING AND 

PERFORMANCE-BASING INSPECTION 

PROCEDURES

The Spent Fuel Project Office (SFPO) is working 

with the Office of Nuclear Reactor Regulation 

(NRR) and coordinating with the Risk Task Group of 

the Office of Nuclear Material Safety and Safeguards 

(NMSS) to risk-inform and performance-base the 

inspection procedures used for independent spent 

fuel storage installations (ISFSIs). The changes to 

procedures will be accomplished in a short-term 

phase and a long-term phase. 

NMSS Licensee Newsletter
c. Revise inspection procedures 

appropriately.

The short-term approach uses risk/consequence 

categories used as ranking factors applied to 

inspection procedure subsections. The categories 

were applied to the existing inspection procedure 

requirements, using an expert-panel approach 

similar to the approach used by NRR, when 

risk- informing elements of the reactor oversight 

process that did not have PRAs associated with the 

element (e.g., security and emergency preparedness 

inspections). This approach uses a risk-informed, 

not risk-based, approach.

Changes in Inspection Report Documentation 

Methods

U.S. Nuclear Regulatory Commission (NRC) 

Manual Chapter (MC) 0610, “Inspection Reports,” 

Appendix D, provides guidance on inspection 

documentation for NMSS inspections. MC 0610 

allows for three methods of inspection 

documentation: narrative, NRC Form 591, and 

inspector notes. SFPO has traditionally used 

the narrative format for documenting inspection 

findings and any related enforcement actions, 

whereas materials inspections typically use the 

latter two methods. 

SFPO plans to implement a pilot program that 

will use both the NRC Form 591 and inspector 

notes, as allowed by MC 0610. NRC Form 

591, used for documenting enforcement status, is 

typically provided to a licensee at the end of 

an inspection, whereas inspector notes, used to 

document inspection findings, are prepared in-office 

after the inspection. Since inspector notes can be 

handwritten or typed, and only require review, and 

approval at the section-chief level, SFPO anticipates 

resource savings through simplification of the report 

documentation, review, and approval process. This 

effort will also help NMSS material-inspection 

documentation to be performed in a more consistent 

manner. NRC and stakeholder resource savings 

are expected through use of NRC Form 591, since 

documentation of, and response to, non-escalated 

enforcement actions, will be greatly simplified.

2

Narrative reports will continue to be used in cases 

of escalated enforcement, reactive or special team 

inspections, and where serious programmatic issues 

are identified. The pilot program will start once the 

SFPO inspection MC has been revised to reflect the 

alternative documentation methods. 

Meeting NRC Strategic Plan Goals

SFPO believes that both efforts described above 

are consistent with and address several of the 

performance goals stated in the NRC fiscal year 

2000 Strategic Plan in the Nuclear Waste Safety 

arena. Specific goals addressed through these two 

efforts are: 1) make NRC activities and decisions 

more effective, efficient, and realistic; and 2) reduce 

unnecessary regulatory burden on stakeholders. 

These efforts will not adversely affect the overall 

strategic goal of maintaining the protection of the 

public health and safety and the environment, and 

the common defense and security.

(Contact: Robert Temps, 301-415-2552; e-mail: 

rrt@nrc.gov)

PUBLICATION OF NUREG- 1717, 

“SYSTEMATIC RADIOLOGICAL 

ASSESSMENT OF EXEMPTIONS FOR 

SOURCE AND BYPRODUCT MATERIALS”

NUREG–1717, “Systematic Radiological 

Assessment of Exemptions for Source and 

Byproduct Materials” has been published in final 

form. The document contains potential radiation 

doses associated with the current exemptions for 

byproduct and source material in Title 10, of 

the U.S.Code of Federal Regulations (10 CFR). 

The study was initiated to assess doses using 

methods consistent with the current requirements 

in 10 CFR Part 20 and current information on 

inventories and uses of the exempt materials. The 

information contained in this NUREG can be used 

to review and examine the radiological impact of 

current exemptions.

Potential radiation doses were estimated for the 

normal life cycle of a particular product or material, 
3

including distribution and transport, intended or 

expected routine use, and disposal, over a 1-year 

time period. Also presented is an assessment 

of potential radiological impacts, associated with 

selected products containing byproduct material, 

which currently may only be used under general 

licenses and may be candidates for exemptions from 

licensing requirements.

The NUREG has been sent to all the Agreement 

States, general licensees, and known facilities using 

or manufacturing products or materials containing 

exempt quantities of radioactive material. The 

NUREG will be available at http://www.nrc.gov/, 

under “Technical Reports in the NUREG Series” on 

the “Reference Library” page.

(Contact: Rosemary Hogan, RES, 301-415-7484; 

e-mail: rth@nrc.gov)

SELECTED FEDERAL REGISTER

NOTICES

(June 1, 2001 - August 31, 2001)

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

“Public Health and Environmental Radiation 

Protection Standards for Yucca Mountain, NV,” 66 

FR 32074, June 13, 2001 (Environmental Protection 

Agency).

Contact: Ray Clark, Office of Radiation and 

Indoor Air, U.S. Environmental Protection Agency, 

Washington, DC. 20460-0001; telephone 

202-564-9310.

“Revision of Fee Schedules; Fee Recovery for FY 

2001,” 66 FR 32452, June 14, 2001.

Contact: Glenda Jackson, OFCO, 301-415-6057; 

e-mail: gcj@nrc.gov.

“List of Approved Spent Fuel Storage Casks: 

Standardized NUHOMS -24P and -52B Revision” 

(Direct Final Rule), 66 FR 34523, June 29, 2001.

Contact: Gordon Gundersen, NMSS , 301-415-6195; 

e-mail: geg1@nrc.gov.

”Revision of Fee Schedules; Fee Recovery for FY 

2001; Correction,” 66 FR 35529, July 6, 2001.

Contact: Glenda Jackson, OCFO, 301-415-6057; 

e-mail : gcj@nrc.gov.

“List of Approved Spent Fuel Storage Casks: 

Westinghouse MC-10 Termination (Direct Final 

Rule),” 66 FR 43761, August 12, 2001.

Contact: Jayne McCausland, NMSS, 301-415-6219; 

e-mail: jmm2@nrc.gov.

“List of Approved Spent Fuel Storage Casks: NACMPC Revision,” 66 FR 45749, August 30, 2001.

Contact: Jayne McCausland, NMSS, 301-415-6219; 

e-mail: jmm2@nrc.gov.

PROPOSED RULES

“List of Approved Spent Fuel Storage Casks: 

Standardized NUHOMS -24P and -52B Revision 

(Companion Proposed Rule),” 66 FR 34588, June 

29, 2001.

Contact: Gordon Gundersen, NMSS, 301-415-6195; 

e-mail: geg1@nrc.gov.

“Revision of the Skin Dose Limit,” 66 FR 36502, 

July 12, 2001.

Contact: Alan K. Roecklein, RES, 301-415-3883; 

e-mail: akr@nrc.gov.

“List of Approved Spent Fuel Storage Casks: 

Westinghouse MC-10 Termination,” 66 FR 43810, 

August 12, 2001. 

Contact: Jayne McCausland, 301-415-6219; e-mail: 

jmm2@nrc.gov.
4

“List of Approved Spent Fuel Storage Casks: NACMPC Revision,” 66 FR 45788, August 30, 2001. 

Contact: Jayne McCausland, NMSS, 301-415-6219; 

e-mail: jmm2@nrc.gov.

OTHER NOTICES

“Governors’ Designees Receiving Advance 

Notification of Transportation of Nuclear Waste,” 66 

FR 34724, June 29, 2001.

Contact: Spiros Droggitis, OSTP, 301-415-2367; 

e-mail: scd@nrc.gov.

“Memorandum of Understanding between the U.S. 

Nuclear Regulatory Commission and the U.S. Army 

Corps of Engineers for Coordination of Cleanup 

and Decommissioning of the Formerly Utilized 

Sites Remedial Action Program (FUSRAP) Sites 

with NRC-Licensed Facilities,” 66 FR 36606, July 

12, 2001.

Contact: Amir Kouhestani, NMSS, 301-415-0023; 

fax (301) 415-5398; e-mail: aak@nrc.gov.

(General Contact: Paul Goldberg, NMSS, 

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

GENERIC COMMUNICATIONS ISSUED

(MAY 1, 2001 - AUGUST 31, 2001)

Note that these are only summaries of U.S. 

Nuclear Regulatory Commission (NRC) 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 NRC library of generic 

communications is -- www.nrc.gov/NRC/GENACT/

GC/index.html. Please note that this address is casesensitive and must be entered exactly as shown.

Information Notices (INs)

IN 2001-08, “Treatment Planning System Errors 

Result in Deaths of Overseas Radiation Therapy 

Patients,” was issued on June 1, 2001. This notice 

was issued to all medical licensees to inform them 

of an international event where several patients were 

overexposed from external beam therapy treatments, 

because of human errors. The notice provided 

preliminary information on the event and stated that 

an update would be provided once an international 

investigation team released its findings.

(Contacts: Robert Ayres, NMSS, 301-415-5746, 

e-mail: rxa1@nrc.gov;

Donna-Beth Howe, NMSS,

301-415-7848, e-mail: dbh@nrc.gov;

Roberto J. Torres, NMSS, 301-415-8112, 

e-mail: rjt@nrc.gov)

IN 2001-08, Supplement 1, “Update on the 

Investigation of Patient Deaths in Panama, 

Following Radiation Therapy Overexposures,” was 

issued on June 6, 2001. This notice was issued 

to all medical licensees to inform them of the 

preliminary findings from the International Atomic 

Energy Agency investigation of patient overdoses 

received during radiation therapy treatments at the 

National Oncology Institute in Panama. 

(Contacts: Robert Ayres, NMSS, 301-415-5746, 

e-mail: rxa1@nrc.gov;

Donna-Beth Howe, NMSS,

301-415-7848, e-mail: dbh@nrc.gov;

Roberto J. Torres, NMSS, 301-415-8112, 

e-mail: rjt@nrc.gov)

IN 2001-11, “Thefts of Portable Gauges,” was issued 

on July 13, 2001. This notice was issued to all 

portable gauge licensees to inform them of recent 

incidents of thefts of portable gauges, and to remind 

them of their responsibilities to prevent loss and 

damage to portable gauges.

(Contact: Samuel L. Pettijohn, NMSS, 301 

415-6822, e-mail: slp@nrc.gov)

Regulatory Issue Summaries (RIS’)

RIS 2001-13, “10 CFR Part 40 Exemptions for 

Uranium Contained in Aircraft Counterweights,” 

was issued on July 20, 2001. This summary 
5

was issued to all holders of licenses authorized 

to manufacture aircraft counterweights containing 

uranium, and organizations and end users that may 

possess such counterweights. The RIS highlights 

the restrictions, applicable to counterweights and 

other products containing uranium, that are exempt 

from licensing requirements. Furthermore, the 

options for transfer and disposal of such products 

were discussed.

(Contact: Joseph E. DeCicco, NMSS, 

301-415-7833, e-mail: jxd1@nrc.gov)

RIS 2001-18, “Requirements for Oath or 

Affirmation,” was issued on August 22, 2001. 

This summary was issued to holders of licenses 

issued under 10 CFR Part 72 and holders of 

certificates issued under 10 CFR Part 76. The RIS 

describes an alternate means of complying with 

the oath or affirmation requirement besides using a 

notary public. This RIS also clarifies the level of 

authority for signing documents that require an oath 

or affirmation. 

(Contacts: Dan Martin, NMSS, 301-415-2754, 

e-mail: dem1@nrc.gov;

Ramin R. Assa, NRR, 301-415-1391,

e-mail: rra@nrc.gov)

(General Contact: Mark A. Sitek, NMSS, 

301-415-5799, e-mail: mas3@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://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

Franklin Hospital Corporation, Franklin, 

Virginia, EA 01-200

On August 1, 2001, a Notice of Violation 

was issued for a Severity Level III violation 

involving the licensee’s failure to maintain control 

and constant surveillance of licensed byproduct 

material involving radiopharmaceuticals in an 

unrestricted area. The licensed material involved 

radiopharmaceuticals that were located in the nuclear 

medicine hot laboratory. The violation occurred 

during the inspection, when the NRC inspector 

observed that the door to the nuclear medicine hot 

laboratory was open and the area unattended and 

unsecured by the Nuclear Medicine Technologists.

South Pittsburgh Cancer Center, Pittsburgh, 

Pennsylvania, EA 01-132

On August 22, 2001, a Notice of Violation and 

Proposed Imposition of Civil Penalty in the amount 

of $8800 was issued for a Severity Level II violation 

involving the deliberate possession of depleted 

uranium (in the form of bricks used for shielding 

within two linear accelerators) without authorization 

in a specific license issued by NRC.

Gauges

Martin Marietta Aggregates, Raleigh, North 

Carolina, EA 01-163

On August 21, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the unauthorized transfer of a fixed gauging device 

containing 1850 mega-becquerels (50 millicuries) 

of cesium-137 to a metal recycling facility not 

authorized to receive and possess such licensed 

material. The transfer occurred before February 

16, 2001, the effective date of the change 

to the Enforcement Policy, which provided that 

notwithstanding the outcome of the normal civil 

penalty assessment process, NRC would normally 

issue a civil penalty in cases involving the loss, 

abandonment, or improper transfer or disposal of 

sources. Therefore, NRC did use discretion to issue 

a civil penalty in this case.

Testwell Laboratories, Inc., Ossining, New York, 

EA 01-149

On June 14, 2001, a Notice of Violation was issued 

for a Severity Level III violation, based on Testwell 

Laboratories, Inc., a licensee of the State of New 
6

York, using portable gauges in New Jersey, a nonAgreement State, without a specific license from 

NRC and without filing a Form 241, “Report 

of Proposed Activities in Non-Agreement State,” 

with NRC. 

Draper Aden Associates, Richmond, Virginia , 

EA 01-107

On June 4, 2001, a Notice of Violation was issued 

for a Severity Level III violation, involving the 

failure to properly block and brace a portable gauge 

before and during transport, that resulted in the 

loss of control of the gauge. The loss occurred 

before February 16, 2001, the effective date of the 

change to the Enforcement Policy, which provided 

that notwithstanding the outcome of the normal civil 

penalty assessment process, NRC would normally 

issue a civil penalty in cases involving the loss, 

abandonment, or improper transfer or disposal of 

sources. Therefore, NRC did use discretion to issue 

a civil penalty in this case.

Midwest Testing, Inc., Bridgeton, Missouri,

EA 01-119

On July 20, 2001, a Notice of Violation and 

Proposed Imposition of Civil Penalty was issued for 

a Severity Level III violation involving the failure 

to control and maintain constant surveillance of a 

portable density gauge, which resulted in the loss 

of the gauge. The loss occurred after February 16, 

2001. Therefore, although the normal civil penalty 

assessment process would have fully mitigated the 

civil penalty, a penalty was proposed in accordance 

with Section VII.A.1.g. of the Enforcement Policy, 

to emphasize the significance of the loss of licensed 

material, in this case. 

Macia Consulting Enterprises, Inc., 

Poughkeepsie, New York, EA 01-123

On May 31, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the failure to maintain required security of 

two portable nuclear density gauges containing 

296 megabecquerels (MBq) 8 millicuries (mCi) 

of cesium-137, and 1480 MBq (40 mCi) of 

americium-241 at a temporary job site (Newark 

International Airport). 

Turabo Corporation, Caguas, Puerto Rico, 

EA 01-126

A Notice of Violation and Proposed Imposition of 

Civil Penalty in the amount of $3000 was issued 

for a Severity Level III violation involving the 

failure to secure from unauthorized removal, or 

limit access to, two gauges containing approximately 

296 megabecquerels (MBq) [8 millicuries (mCi)] 

of cesium-137, and 1850 MBq (50 mCi) of 

americium-241, and failure to control and maintain 

constant surveillance of this licensed material. 

SWVA, Inc. d/b/a Steel of West Virginia, Inc., 

Huntington, West Virginia, EA 01-128

On June 27, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the failure to secure from unauthorized removal, 

or limit access to, three gauges containing 185 

gigabecquerels (500 millicuries) of cesium-137, and 

failure to control and maintain constant surveillance 

of this licensed material.

Radiography

Stork MSC, Louisville, Kentucky, EA 01-164

On August 3, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving the 

failure to control or maintain constant surveillance 

of a radiography exposure device containing 

approximately 1073 gigabecquerels (29 curies) of 

iridium-192 in an unrestricted area.

Allied Inspection Services, Inc., St. Clair, 

Michigan, EA 01-099

On June 4, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the willful failure to test exposure devices using 

depleted uranium (DU) shielding and an “S” tube 

configuration for DU contamination, within the 

required interval.
7

enforcement discretion in accordance with Section 

VII.B.6 of the Enforcement Policy and refrained 

from issuing a civil penalty because the licensee 

was issued a civil penalty for the event by the State 

of South Carolina, and the licensee is no longer 

a licensee.

United States Enrichment Corporation, Paducah, 

Kentucky, EA 99-256 and EA 00-047

On January 3, 2001, a Notice of Violation was 

issued for a Severity Level III problem involving: (1) 

creation of classified information on an unclassified 

computer system; and (2) deliberate failure to report 

the infraction to the NRC Regional Administrator 

per regulation; and a Severity Level III violation 

involving the deliberate failure to initiate a corrective 

action report for the security infraction.

Black Warrior Wireline Corporation, Gray, 

Louisiana, EA 01-095

On May 27, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the failure of Black Warrior Wireline Corporation, 

a licensee of the State of Louisiana, to file 

NRC Form 241, “Report of Proposed Activities in 

Non-Agreement State, Areas of Exclusive Federal 

Jurisdiction, or Offshore Waters,” before conducting 

well-logging operations using americium-241/

beryllium sealed sources in offshore waters off the 

Gulf of Mexico in areas of Federal jurisdiction.

Mallinckrodt, Inc., St. Louis, Missouri, 

EA 01-108

On July 3, 2001, a Notice of Violation was issued for 

a Severity Level III violation involving the failure to 

prepare a package containing licensed material that 

was transported outside the confines of the licensee’s 

plant, so that under conditions normally incident to 

transport, the radiation levels would not exceed 2 

millisievert (200 millirems) per hour at any point on 

the external surface of the package.

Vendors

JL Shepherd & Associates, San Fernando, 

California, EA 01-164

On July 3, 2001, an immediately effective Order 

Withdrawing Quality Assurance Approval was 

issued. The Order was based on the Agency’s lack 

of confidence that the company would implement 

the NRC-approved Quality Assurance Program, in 

accordance with NRC regulations, in a manner that 

would assure the required preparation and use of 

transportation packages, in full conformance with 

these NRC regulations.

SMI East Coast Medical Waste, Inc., Morrisville, 

Pennsylvania, EA 01-064

On August 16, 2001, a Notice of Violation was 

issued for a Severity Level III violation involving 

the company’s willful actions in receiving byproduct 

material that it was not authorized to possess, 

in accordance with a general or specific license, 

and in providing NRC with incomplete and 

inaccurate information.

Other

Framatome ANP Richland, Inc., Richland, 

Washington, EA 99-154

On June 5, 2001, a Notice of Violation was issued 

for a Severity Level III problem involving willfully: 

(1) shipping licensed material in unapproved 

packages; (2) exporting licensed material that did 

not meet required packaging requirements; (3) 

certifying, in shipping papers, that an export 

shipment complied with applicable shipping 

requirements; and (4) failing to maintain approved 

operating procedures. 

Arthur Brisbane Child Treatment Center, 

Farmindale, New Jersey EA 99-171

On August 16, 2001, a Notice of Violation was 

issued for a Severity Level III problem involving 

deliberate improper disposal of radioactive material 

generated from the cleanup of a broken exit sign 

and deliberate submittal of inaccurate information 

to NRC. Although a base civil penalty would 

normally be proposed for this case, NRC exercised 
8

(Contact: John Lubinski, OE 301 415-2740; 

e-mail:jul@nrc.gov)

SIGNIFICANT EVENTS

The U.S. Nuclear Regulatory Commission (NRC) 

is providing summaries of these events to inform 

licensees of conditions they may encounter and of 

actions that may be taken to deal with them.

Event 1: Misadministration involving the 

TheraSphere® (yttrium-90 glass microspheres) 

device at the University of Maryland, Baltimore, 

Maryland.

Date and Place: October 17, 2000; University of 

Maryland; Baltimore, Maryland.

Nature and Probable Consequences: The licensee 

reported a medical event involving a 31-year-old 

male patient who received 23.4 percent of the 

prescribed 150- Gray (15,000 - rad) dose while 

undergoing brachytherapy treatment for liver cancer. 

The dose was administered using the TheraSphere® 

device, a brachytherapy system manufactured by 

MDS Nordion. The TheraSphere® device is 

comprised of a unit dose of yttrium-90 glass 

microspheres and a prepackaged administration kit. 

The administration assembly is used to infuse the 

yttrium-90 microsphere dose into the hepatic artery 

to treat liver cancer. The licensee had performed this 

procedure successfully 10 times before this event. 

The licensee’s preliminary evaluation indicated a 

problem with the delivery system, resulting from an 

air leak in the rubber cap of the source vial at the site 

of the needle insertions. The licensee suspected that 

the inlet needle and the outlet needle may have been 

inserted too closely to each other, causing the rubber 

cap to lose its self-seal capability.

Subsequent to the licensee’s evaluation of this 

misadministration, MDS Nordion performed a 

follow-up investigation on the involved 

TheraSphere® source vial, and an analysis of the 

cause of the event. It provided its findings and 

corrective actions in a report issued to the State of 

Maryland on February 20, 2001. MDS Nordion 

reported that the misadministration at the University 

of Maryland on October 17, 2000, occurred because 

the dose vial septum integrity was compromised 

during the placement of the inlet and outlet needles 

closely adjacent to each other, causing leakage 

from the source vial. Additional investigative 

studies with unused source vials showed that 

leaking at the dose vial septum through the needle 

punctures occurred when vial pressures were above 

atmospheric pressure.

Actions Taken To Prevent Recurrence

Licensee: The licensee temporarily suspended 

treatments using TheraSphere® (yttrium-90 glass 

microspheres) and resumed with assistance from the 

manufacturer.

MDS Nordion, TheraSphere® manufacturer: MDS 

Nordion now supplies sterile lucite needle guides, 

with all administration sets, for users to insert into 

the source vials before the needles are inserted. The 

needle guides provide accurate needle alignments 

through the source vial septum and also prevent 

needle-induced stress on the vial septums. MDS 

Nordion reported that the needle guides were 

used in 15 administrations at the University of 

Maryland between October 17, 2000, and February, 

2001, without a repeat misadministration. No 

other TheraSphere® misadministrations have been 

reported to NRC since the event at the University of 

Maryland on October 17, 2000.

Event 2: Overexposure of an assistant radiographer 

working for Quality Inspection Services, in 

Jacksonville, Florida.

Date and Place: February 16, 2001; Jacksonville 

Electric Authority’s Northside Repowering Station; 

Jacksonville, Florida.

Nature and Probable Consequences: The licensee 

reported a possible overexposure, to an assistant 

radiographer, of 39.2 centisievert (cSv) (rem) 

while performing industrial radiography. The 

radiographers were using an AEA Technology 

camera (model 660-B) with an iridium-192 source 

containing an activity of 2.15 tetrabecquerels (58 

curies). After a radiography shot, the source 

was reeled into what was thought to be a 

locked, shielded, and fully retracted position. The 

radiographers failed to perform an adequate survey 

of the camera. The two radiographers involved 
9

proceeded in front of the camera to set up the 

next shot, taking less than 5 minutes. When they 

went to unlock the source, they realized that it was 

not locked and noticed the survey meter was offscale. They left the area and fully retracted the 

source. Both pocket dosimeters were off- scale. 

One radiographer’s alarming ratemeter was turned 

off and the other radiographer’s alarming ratemeter 

had a low battery and did not give an audible 

alarm. Film badges for the two radiographers 

showed exposures of 2.9 and 39.2 Centigray (rad). 

The assistant radiographer whose badge showed the 

highest exposure had blood drawn for analysis. In 

addition, the licensee conducted a re-enactment of 

the event. Landauer was asked to recheck the 

film badge results and the results were the same as 

initially reported. The licensee chose not to perform 

cytogenetic blood testing, but chose to perform a 

white blood cell count only. The Florida Bureau of 

Radiation Control would not expect to see a white 

blood cell deviation at that level of exposure. There 

have been no signs of erythema in the individual. 

During the Bureau’s investigation it was determined 

that the assistant radiographer was exposed to 39.2 

cSv (rem) (total effective dose equivalent), based on 

the measurement of the personnel monitoring badge 

worn by the individual.

Actions Taken To Prevent Recurrence

Licensee: Corrective actions taken include the 

designation of a new Radiation Safety Officer (RSO) 

who had completed the required RSO training, 

and development of quality assurance methods 

for instrument functionality, calibration due dates, 

battery replacement dates, and tracking of film 

badges. In addition, the licensee will develop a 

radiographer’s awareness synopsis of the company’s 

operating and emergency procedure manual.

State Agency: The Florida Bureau of Radiation 

Control cited the licensee for allowing the assistant 

radiographer to exceed the annual exposure limit, 

for not performing adequate surveys of the 

camera after each radiographic exposure, and for 

allowing the radiographers to perform work without 

operating ratemeters.

Event 3: High-Dose-Rate Remote Afterloader 

Medical Event at Saint Joseph’s Regional Health 

Center in Hot Springs, Arkansas.

Date and Place: March 6, 2001; Saint Joseph’s 

Regional Health Center; Hot Springs, Arkansas.

Nature and Probable Consequences: The licensee 

reported, on April 12, 2001, to the Arkansas 

Department of Health (ADH), a medical event 

involving the superficial treatment of skin cancer 

using iridium-192 (Ir-192) in a Varian VariSource 

High-Dose- Rate Remote Afterloader unit. ADH 

conducted an investigation of the event and 

determined that the radiation oncologist had 

prescribed a total dose of 6000 centigray (cGy) (rad) 

to the hand webbing between the index and middle 

fingers of the patient’s left hand, to be delivered 

during 30 fractions of 200 cGy (rad) each. The 

patient had received 24 of the 30 fractions, beginning 

March 6, 2001, through April 11, 2001, for a total 

of 4800 cGy (rad) before the misadministration 

was identified. The treatment was administered 

using a custom-made applicator with imbedded 

FlexiGuide needles. The treatments were provided 

without performing an autoradiograph to confirm the 

treatment positions. On April 11, 2001, the radiation 

oncologist requested that the physicist verify the 

treatment site. Positioning of the treatment delivery 

system was confirmed by autoradiograph, and the 

length of the FlexiGuide needles was confirmed to 

be 25-centimeters (cm) [10-inches (in.)] long. The 

physicist had assumed that the needles were 20-cm 

(8-in.) long , instead of the actual 25-cm (10-in.) 

long, and therefore the remote afterloader unit was 

programmed incorrectly. This resulted in the Ir-192 

source being incorrectly positioned approximately 

5 cm (2 in.) from the intended treatment site. 

Therefore, the back of the patient’s hand rather 

than the hand webbing was treated. The patient was 

notified of the medical event on April 11, 2001, 

and a revised treatment plan was developed. The 

licensee completed an evaluation of the possible 

health effects on the patient. The patient developed 

an area of erythema on the back of the left hand. No 

severe long-term effects are anticipated. However, it 

is likely the patient will have dry skin in that area. 

There is a very small risk (less than 5 percent) that 

the patient may develop scar tissue on the first and/or 

second dorsal interosseus muscles of the left hand or 

the extensor tendon and related connective tissues of 

the second digit of the left hand. 
10

Actions Taken to Prevent Recurrence

Licensee: Corrective actions taken included 

documenting that the catheter lengths were verified, 

and confirmation of the catheter lengths (source 

location) by an autoradiograph, if possible. Also 

the licensee made changes to the checklist, on the 

Quality Management Program, for verification of 

proper procedures.

State Agency: The ADH, conducted an investigation 

of this medical event on April 13, 2001. Based on 

the results of the investigation, a notice of violation 

letter was issued on April 17, 2001. A Management 

Conference with the medical center administration 

was held to identify and discuss possible root causes 

and corrective actions. ADH approved the licensee’s 

corrective actions, and the incident was closed on 

June 1, 2001.

Event 4: Sodium Iodide Radiopharmaceutical 

Medical Event at Parkview Memorial Hospital in 

Fort Wayne, Indiana.

Date and Place: March 26, 2001; Parkview 

Memorial Hospital; Fort Wayne, Indiana.

Nature and Probable Consequences: The licensee 

reported a medical event involving the 

administration of a thyroid ablation dose of 

iodine-131 (I-131) that was 28 percent higher than 

what was prescribed. A 65-year-old female patient 

was prescribed a dose of 4.63 gigabecquerels (GBq) 

125 millicuries (mCi) of I-131. The technician 

inadvertently administered 5.92 GBq (160 mCi) of 

I-131. The error is attributed to the past practice of 

physicians ordering 5.55-GBq (150- mCi) doses (+/- 

10 percent), which is what the technician ordered 

from the nuclear pharmacy without receipt of the 

written directive. The 5.55- GBq (150- mCi) 

dose was such a standard that when the therapy 

was scheduled, the computer automatically included 

“150-mCi” on the schedule. The licensee’s Quality 

Management Program (QMP) form also listed “I-131 

150- mCi scan” as a type of procedure to be 

conducted. The presribing doctor informed the 

patient and the referring physician informed of the 

event. The prescribing physician concluded that this 

event resulted in no change in the clinical outcome 

and that the increased dosage did not pose a high risk 

for the patient.

Actions Taken to Prevent Recurrence

Licensee: Corrective actions include requiring 

separate verification of the prescribed dosage, 

requiring written directives at the time doses are 

ordered, and deleting the reference to “150-mCi” 

on the QMP forms, procedure lists, and 

patient schedule.

NRC: An NRC medical consultant conducted an 

assessment and determined that the administered 

dose was not outside the standard of care.

Event 5: Sodium Iodide Radiopharmaceutical 

Medical Event at Kaiser Permanente, in 

Denver, Colorado.

Date and Place: June 29, 2001; Kaiser Permanente; 

Denver, Colorado.

Nature and Probable Consequences: The licensee 

reported a medical event involving two patients who 

received 59 and 60 percent more iodine-131 (I-131) 

than what was prescribed. A spokesman from 

the radiopharmaceutical company that delivered the 

I-131, Syncor International Corporation, stated that 

it had miscalculated the activity in three I-131 doses 

that were delivered to two clients. The doses were 

assayed using incorrect settings on Syncor’s dose 

calibrator. One client identified the error during its 

assay of the dose before administration to a patient. 

However, the other client, Kaiser Permanente’s (a 

licensee from the State of Colorado) administered 

the doses to two patients after measuring the activity 

on its dose calibrator. Kaiser Permanente’s staff 

mistakenly accepted Syncor’s assay instead of the 

activity measured by its dose calibrator. The 

licensee’s authorized user had prescribed a 0.19- 

gigabecquerel (GBq) (5-mCi) dose for a whole body 

scan and a 0.56-GBq (15-mCi) dose for the treatment 

of hyperthyroidism. The doses dispensed by Syncor 

contained 0.30 GBq (7.97 mCi) and 0.89 GBq (24 

mCi), respectively.

Actions Taken to Prevent Recurrence

Licensee: Syncor took the corrective actions of 

posting a sign stating “Check the dose calibrator 

to ensure the setting is at I-131”; refresher training 

on procedures for all pharmacists; modification of 

the procedures for the daily constancy test; and 
11

acquisition of a new dose calibrator to be used 

for I-131.

Kaiser Permanente took the corrective actions of 

documenting doses administered to the patients; 

retraining nuclear medicine staff on the use of the 

dose calibrator; and training on whom to contact in 

case of problems.

State Agency: The Colorado Department of Public 

Health and Environment issued a Notice of 

Violation to Kaiser Permanente for having an I-131 

misadministration and for lack of training.

(Contact: Roberto Torres, NMSS, 301-415-8112; 

e-mail: rjt@nrc.gov)

Comments, and suggestions you may have for 

information not currently 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