27192 Federal Register / Vol. 74, No. 108 / Monday, June 8, 2009 / Notices 

Policy will be available at http:// 

www.nrc.gov/about-nrc/regulatory/ 

enforcement/public-involvement.html. If 

you do not have Internet access or if 

there are problems in accessing the 

documents located in ADAMS, contact 

the PDR Reference staff at 1–800–397– 

4209, 301–415–4737 or by e-mail to 

pdr.resource@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Doug Starkey, Office of Enforcement, 

U.S. Nuclear Regulatory Commission, 

Washington, DC 20555; 

Doug.Starkey@nrc.gov, 301–415–3456. 

SUPPLEMENTARY INFORMATION: 

Background 

As discussed in the SUPPLEMENTARY

INFORMATION of the September 15, 2008 

document (73 FR 53286), the NRC, in 

developing the proposed revised 

Enforcement Policy, in many instances 

reworded, deleted, or moved (i.e., 

moved to the NRC Enforcement Manual, 

an NRC staff guidance document) some 

of the information in the current 

Enforcement Policy. (See the table at 

ML083050133 for a listing of subject 

matter in the current Enforcement 

Policy which was not carried over into 

the proposed revised Enforcement 

Policy.) For example, Section 6.0, 

Supplements–Violation Examples, of 

the proposed revised Enforcement 

Policy was significantly reorganized, 

reworded, and contained much less 

detail than the supplements in the 

current Enforcement Policy. In addition, 

the NRC had also planned to add 

detailed violation examples to the 

Enforcement Manual to serve as further 

guidance to NRC inspectors. However, 

based on public comments received in 

response to the September and October 

2008 publications of the proposed 

revised Enforcement Policy, the NRC 

has reconsidered its original plan to 

have abbreviated violation examples in 

the revised Enforcement Policy and 

detailed violation examples in the 

Enforcement Manual. The NRC now 

proposes to continue its past practice of 

providing violation example 

supplements in the Enforcement Policy. 

These revised supplements are intended 

to cover, in more detail than originally 

planned, a broad range of circumstances 

in each of the four severity levels in 

each of 14 activity areas. It should be 

noted that the supplements in Section 

6.0 of the proposed revised Enforcement 

Policy are not intended to address every 

possible circumstance and are therefore 

neither exhaustive nor controlling. 

Because the revised violation 

supplements that are being proposed for 

the revised Enforcement Policy have, in 

some instances, been changed 

significantly from those previously 

published, the NRC is providing an 

opportunity for public comments on the 

proposed revised supplements. 

The NRC maintains the Enforcement 

Policy on its Web site at http:// 

www.nrc.gov; select Public Meetings 

and Involvement, Enforcement, and 

then Enforcement Policy. 

Procedural Requirements: 

Paperwork Reduction Act 

This policy statement does not 

contain new or amended information 

collection requirements subject to the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). Existing 

requirements were approved by the 

Office of Management and Budget 

(OMB), approval number 3150–0136. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

Congressional Review Act 

In accordance with the Congressional 

Review Act of 1996, the NRC has 

determined that this action is not a 

major rule and has verified this 

determination with the Office of 

Information and Regulatory Affairs. 

For the Nuclear Regulatory Commission. 

Dated at Rockville, MD, this 1st day of June 

2009. 

Cynthia A. Carpenter, 

Director, Office of Enforcement. 

[FR Doc. E9–13298 Filed 6–5–09; 8:45 am] 

BILLING CODE 7590–01–P 

NUCLEAR REGULATORY 

COMMISSION 

[NRC–2009–0208] 

Report to Congress on Abnormal 

Occurrences; Fiscal Year 2008; 

Dissemination of Information 

Section 208 of the Energy 

Reorganization Act of 1974 (Pub. L. 93– 

438) defines an abnormal occurrence 

(AO) as an unscheduled incident or 

event which the U.S. Nuclear 

Regulatory Commission (NRC) 

determines to be significant from the 

standpoint of public health or safety. 

The Federal Reports Elimination and 

Sunset Act of 1995 (Pub. L. 104–68) 

requires that AOs be reported to 

Congress annually. During Fiscal Year 

2008, ten events that occurred at 

facilities licensed or otherwise regulated 

by the NRC and/or Agreement States 

were determined to be AOs. The report 

describes five events at NRC-licensed 

facilities. The first NRC-licensee event 

involved radiation exposure to an 

embryo/fetus. The other four NRClicensee events were medical events, as 

defined in Title 10, Part 35, of the Code 

of Federal Regulations (10 CFR Part 35). 

All five NRC-licensee events occurred at 

medical institutions. The report also 

describes five events at Agreement 

State-licensed facilities. [Agreement 

States are those States that have entered 

into formal agreements with the NRC 

pursuant to Section 274 of the Atomic 

Energy Act (AEA) to regulate certain 

quantities of AEA licensed material at 

facilities located within their borders.] 

Currently, there are 35 Agreement 

States. The first Agreement Statelicensee event involved radiation 

exposure to an embryo/fetus. The other 

four Agreement State-licensee events 

were medical events, as defined in 10 

CFR Part 35, and occurred at medical 

institutions. As required by Section 208, 

the discussion for each event includes 

the date and place, nature and probable 

consequences, the cause or causes, and 

the actions taken to prevent recurrence. 

Each event is also being described in 

NUREG–0090, Vol. 31, ‘‘Report to 

Congress on Abnormal Occurrences: 

Fiscal Year 2008.’’ This report is 

available electronically at the NRC Web 

site http://www.nrc.gov/reading-rm/doccollections/nuregs/staff/. 

There are three major categories of 

events reported in this document: I. For 

All Licensees, II. For Commercial 

Nuclear Power Plant Licensees, and III. 

Events at Facilities Other Than Nuclear 

Power Plants and all Transportation 

Events. The full report, available on the 

NRC Web site, provides the specific 

criteria for determining when an event 

is an abnormal occurrence (AO) and 

discusses ‘‘Other Events of Interest’’ that 

do not meet the AO criteria but which 

the Commission has determined should 

be included in the report. The event 

identification number begins with ‘‘AS’’ 

for Agreement State AO events and 

‘‘NRC’’ for NRC AO events. 

I. For All Licensees 

Human Exposure to Radiation From 

Licensed Material 

During this reporting period, one 

event at an NRC-licensed facility and 

one event at an Agreement Statelicensed facility were significant enough 

to be reported as abnormal occurrences 

(AOs). 


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AS08–01 Human Exposure to 

Radiation at St. Luke’s Hospital in 

Bethlehem, Pennsylvania 

Date and Place—April 11, 2008, 

Bethlehem, Pennsylvania. 

Nature and Probable Consequences— 

St. Luke’s Hospital (the licensee) 

reported that a therapeutic dose of 4,958 

MBq (134 mCi) of iodine-131, for 

thyroid cancer treatment, resulted in a 

dose to an embryo/fetus of 350 mSv (35 

rem). Prior to administration of iodine131, the patient was given a pregnancy 

test and it yielded a negative result. 

Following the treatment, the patient 

suspected she was pregnant and 

returned to the hospital on April 28, 

2008. Subsequent testing indicated that 

the patient became pregnant 

approximately 4–6 days following her 

treatment. The patient and the referring 

physician were informed of this event. 

The hospital calculated a total dose to 

the embryo/fetus of 350 mSv (35 rem). 

The hospital concluded that based on 

the total dose to the embryo/fetus of 350 

mSv (35 rem), no immediate health 

effects would be experienced. On May 

2, 2008, the patient met with a 

perinatologist and a recommendation 

was made to consult with a genetic 

counselor regarding the fetal exposure. 

Cause(s)—The causes of this event 

were the negative pregnancy test and 

the patient not using a method of 

contraception, as advised, following the 

treatment. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee is providing 

additional instructions to its staff to 

strongly emphasize to patients the risks 

associated with becoming pregnant 

following the administration of 

radioiodine treatments. 

State—The State conducted a followup inspection on June 10, 2008, and did 

not take any enforcement action 

regarding this event. 

* * * * * 

NRC08–01 Human Exposure to 

Radiation at Wilford Hall Medical 

Center on Lackland Air Force Base in 

San Antonio, Texas 

Date and Place—June 4, 2008, San 

Antonio, Texas. 

Nature and Probable Consequences— 

Wilford Hall Medical Center, a permit 

holder under the United States Air 

Force (USAF) Master Material license, 

reported that a therapeutic dose of 5.55 

GB (150 mCi), for post-thyroidectomy 

therapy to a patient, administered on 

June 4, 2008, resulted in a dose to an 

embryo/fetus of 315 mSv (31.5 rem). 

Two days prior to administration of the 

radioiodine-131, a pregnancy test was 

given to the patient and it yielded a 

negative result. Later, on June 26, 2008, 

the patient became aware that she was 

pregnant. The hospital’s radiation safety 

staff did not become aware of the 

pregnancy until August 13, 2008, when 

the patient contacted the radiation 

safety staff asking about the 

consequences of the radioiodine 

ablation therapy on her embryo/fetus. 

The hospital’s radiation safety staff 

immediately conducted an 

investigation, in consultation with 

experts at the Department of Energy, 

and concluded that based on the total 

dose calculated of 315 mSv (31.5 rem) 

to the embryo/fetus, no immediate 

health effects would be experienced. 

The hospital estimated that the 

pregnancy was approximately seven 

days post-conception at the time of the 

administration and that the zygote 

(fertilized ovum) was in a preimplantation state. This estimated 

condition is supported by the negative 

pregnancy test results prior to the 

administration. In addition, the hospital 

also estimated that the likelihood of 

childhood cancer had been increased by 

an estimated 1.9 percent. According to 

the licensee’s report dated September 

22, 2008, the pregnancy was progressing 

satisfactorily. 

Cause(s)—Wilford Hall Medical 

Center believes that it followed its 

policies and standards of care. A 

pregnancy test does not typically have 

the capability to detect a pregnancy at 

such an early stage. The NRC special 

inspection is complete and the results 

are being evaluated for significance and 

potential regulatory action. The final 

report will be issued at the completion 

of the evaluation. 

Actions Taken To Prevent Recurrence 

Wilford Hall Medical Center—Patients 

will be advised that serum pregnancy 

tests are not capable of detecting early 

stage pregnancy and therefore patients 

will be advised to abstain from 

intercourse for a period of 14 days prior 

to treatment or utilize an effective 

method of contraception for a period of 

30 days prior to treatment. In addition, 

only quantitative serum tests will be 

used for detecting pregnancy for 

patients with the physiological capacity 

for becoming pregnant. 

Department of the Air Force—The 

United States Air Force (USAF) 

Radioisotope Committee (RIC) is 

performing a root-cause analysis of this 

event. As part of its reviews, the USAF 

RIC is identifying other hospitals, under 

its Master Materials license, and asking 

them to review radioiodine procedures 

for the past two years to determine if 

patients had become pregnant either 

before or after receiving a radioiodine 

procedure. The USAF RIC will also 

review the policies and procedures of 

these hospitals. In addition, the USAF 

RIC is arranging to send an inspector 

from the Air Force Inspection Agency to 

further assess procedures. The USAF 

Surgeon General issued a Notice to 

Airmen (NOTAM) on September 22, 

2008, that outlined compliance 

objectives to reduce the likelihood of 

future occurrences. The USAF RIC is 

sending information to educate 

clinicians and support staff on the 

intent and implementation of the 

NOTAM. 

NRC—NRC first learned of this 

incident on September 5, 2008, while 

conducting a routine unannounced 

inspection at Wilford Hall Medical 

Center. On September 9, 2008, NRC 

initiated a special inspection team to 

review this event and obtained the 

services of a medical consultant. NRC’s 

medical consultant corroborated the 

hospital’s total dose estimate to the 

fetus, with an estimated total dose of 

325 mSv (32.5 rem). NRC’s medical 

consultant also concurred with the 

hospital’s assessment of the probable 

health effects to the fetus. 

* * * * * 

II. Commercial Nuclear Power Plant 

Licensees 

During this reporting period, no 

events at commercial nuclear power 

plants in the United States were 

significant enough to be reported as 

AOs. 

* * * * * 

III. Events at Facilities Other Than 

Nuclear Power Plants and All 

Transportation Events 

Medical Licensees 

During this reporting period, four 

events at NRC-licensed or regulated 

facilities and four events at Agreement 

State-licensed facilities were significant 

enough to be reported as AOs. 

NRC08–02 Medical Events at the 

Department of Veterans Affairs in 

Philadelphia, Pennsylvania 

Date and Place—February 2002 to 

May 2008, Philadelphia, Pennsylvania. 

Nature and Probable Consequences— 

The VA Medical Center—Philadelphia 

reported that 92 medical events 

involving prostate brachytherapy 

occurred between February 2002 and 

May 2008. Each patient was prescribed 

160 Gy (16,000 rad) using permanent 

iodine-125 seeds. The licensee 

determined that 57 of the 92 patients 

received less than 80 percent of the 

prescribed dose to the prostate. ThirtyVerDate Nov<24>2008 15:15 Jun 05, 2009 Jkt 217001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 E:\FR\FM\08JNN1.SGM 08JNN1

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five patients received excessive doses to 

other organs. Of these 35 patients, 25 

patients received a dose in excess of 100 

Gy (10,000 rad) to the rectum due to 

misplaced iodine-125 seeds. Each 

patient and the referring physicians 

were notified of these events. The VA 

Medical Center—Philadelphia is 

reviewing possible health effects on the 

patients. The circumstances for each 

patient are being evaluated to determine 

if follow-up medical care is needed. 

The NRC-contracted medical 

consultant reviewed a selected number 

of the cases and agreed with the 

licensee’s dose analysis. However, in 

one overdose case, the patient 

experienced rectal bleeding of the colon 

and laboratory results indicated 

ulcerative colitis. The NRC-contracted 

medical consultant and the licensee 

agreed that the increased dose to the 

colon could be a contributing factor to 

the rectal bleeding. 

Cause(s)—The VA Medical Center— 

Philadelphia identified three root causes 

as a result of these events in its Report 

of Administrative Board of Investigation 

dated September 5, 2008: (1) No 

corrective action was taken when postimplant dosimetry was performed and 

low doses were observed, (2) inadequate 

supervision by the physician/authorized 

users and (3) post-treatment plans were 

not performed on patients due to 

computer interface problems. In 

addition, two factors contributed to 

these events: (1) Internal procedures 

were not followed and (2) the 

succession of minor technical errors that 

stemmed from a misperception that 

other team members performed safety 

checks. 

Actions Taken To Prevent Recurrence 

Licensee—Corrective actions taken by 

the VA Medical Center—Philadelphia 

included: (1) The prostate 

brachytherapy program has been 

suspended until a standardized 

brachytherapy program is established 

and implemented; (2) a physician and 

medical physics consultant, who are 

experts in performing prostate implants, 

were hired to evaluate the prostate 

implant program; and (3) several key 

staff directly involved in the prostate 

brachytherapy procedures are no longer 

employed by the VA Medical Center— 

Philadelphia. 

NRC—The NRC Region III Office 

conducted a reactive inspection on July 

23–25, 2008. Based on the results of this 

inspection and the high number of 

medical events identified, NRC 

conducted a special inspection on 

September 9–12, 2008. On October 14, 

2008, NRC issued a confirmatory action 

letter (CAL) to the Department of 

Veterans Affairs (DVA) National Health 

Physics Program due to the multiple 

medical events involving permanent 

prostate brachytherapy treatments. The 

CAL documents the commitments made 

by the DVA to identify and address the 

problems that have led to medical errors 

and to prevent their recurrence. NRC 

will verify, through inspections, that the 

items in the CAL have been successfully 

completed. Enforcement action is 

pending. 

* * * * * 

NRC08–03 Medical Event at Karmanos 

Cancer Center in Detroit, Michigan 

Date and Place—October 24, 2007, 

Detroit, Michigan. 

Nature and Probable Consequences— 

Karmanos Cancer Center reported that a 

medical event occurred associated with 

its gamma stereotactic radiosurgery unit 

(gamma knife). A patient being treated 

for a metastatic brain tumor was 

scheduled to receive 18 Gy (1,800 rad) 

to the lesion in the right cerebella area 

of the brain but received 18 Gy (1,800 

rad) to an unintended area adjacent to 

the tumor. An error in the setup of the 

magnetic resonance imaging (MRI) unit 

caused the MRI scan to be reversed (i.e., 

the image of the right side of the head 

was on the left side and vice versa). The 

patient and the referring physician were 

informed of this event. 

Prior to the treatment, the medical 

physicist, authorized user physician, 

and neurosurgeon reviewed the MRI 

scan and treatment plan but failed to 

recognize the reversed MRI images. The 

reversed MRI images were scanned into 

the gamma knife treatment planning 

computer, and a treatment plan was 

generated based on the reversed MRI 

images. The authorized user physician 

and neurosurgeon reviewed and 

approved the treatment plan generated 

from the reversed MRI images, and 

again the reversed MRI images were not 

recognized. 

The NRC staff conducted a reactive 

onsite inspection on October 29, 2007. 

The NRC-contracted medical consultant 

reviewed the case and agreed with the 

licensee’s analysis, stating that no 

significant adverse health effect to the 

patient is expected. 

Cause(s)—The medical event was 

caused by the MRI technologist who 

inadvertently performed the MRI scans 

in the ‘‘caudal’’ mode (from the jaw to 

the top of the head) rather than the 

‘‘cranial’’ mode (from the top of the 

head to the jaw). This change in device 

mode caused the MRI images to be 

reversed. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee initiated 

several corrective actions to reduce the 

likelihood of recurrence of a similar 

event. Specifically, those corrective 

actions included (1) weekly meetings 

with the physics staff to discuss 

technical issues, focusing on the 

importance of good communication and 

(2) new written procedures and policies 

for the MRI staff and gamma knife 

facility staff that require dual 

verification of the various steps in the 

process to ensure that the correct 

treatment plan is generated from the 

MRI images. 

NRC—On January 10, 2008, NRC 

issued a Notice of Violation related to 

this event. 

* * * * * 

AS08–02 Medical Event at University 

of Mississippi Medical Center in 

Jackson, Mississippi 

Date and Place—December 12¥17, 

2007, Jackson, Mississippi. 

Nature and Probable Consequences— 

University of Mississippi Medical 

Center (the licensee) reported that a 

medical event occurred during a high 

dose-rate (HDR) treatment for cervical 

cancer using an iridium-192 source with 

an activity of 185 GBq (5.0 Ci). The 

authorized user physician prescribed 

five fractionated doses of 600 cGy (600 

rad) each to be administered using 

tandem and ovoid applicators. The 

licensee calculated that during the first, 

second, and third fractionated 

treatments, the patient received a total 

dose of 470 cGy (470 rad) to the 

treatment area and 1,300 cGy (1,300 rad) 

to the vaginal region inferior to the 

treatment area. The patient and the 

referring physician were informed of 

this event. The licensee concluded that 

no significant adverse health effect to 

the patient is expected. 

Cause(s)—The medical event was 

caused by human error due to the 

incorrect catheter length entered into 

the treatment planning system. The 

incorrect value of 128 cm was entered 

as the length instead of 120 cm, 

resulting in the 86 mm displacement. 

An HDR service technician identified 

the error in the treatment planning 

system on March 25, 2008. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee committed to 

taking several corrective actions as a 

result of the medical event, including 

(1) Verification of the length of all 

disposal catheters and checking the 

integrity of the catheters prior to 

treatment, (2) placing an order for and 

use of a single set of reusable catheters 


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for HDR cervical cancer treatments, (3) 

the treatment plan and catheter 

measurement will be independently 

checked prior to treatment, and (4) 

review and modification, if necessary, of 

the quality assurance plan to ensure 

accuracy. 

State—The State cited the licensee 

with two violations for failing to verify 

the treatment plan. 

* * * * * 

AS08–03 Medical Event at Southwest 

Volusia Healthcare Corporation in 

Orange City, Florida 

Date and Place—December 28, 2007, 

Orange City, Florida. 

Nature and Probable Consequences— 

Southwest Volusia Healthcare 

Corporation (the licensee, doing 

business as Florida Hospital Fish 

Memorial) reported that a patient 

received 81.4 MBq (2.2 mCi) of iodine131 for a whole body scan, instead of 

the intended iodine-123 for a thyroid 

uptake scan. The administration of 81.4 

MBq (2.2 mCi) of iodine-131 resulted in 

the patient receiving a dose of 17.6 Gy 

(1,760 rad) to the thyroid and a whole 

body effective dose equivalent of 1.034 

cGy (1.034 rad). The authorized user 

physician ordered an iodine thyroid 

uptake scan procedure, but did not 

specify the isotope in the written 

directive. The licensee uses iodine-123 

for thyroid uptake scan procedures and 

iodine-131 for whole body scan 

procedures. On December 17, 2007, the 

patient received an iodine-131 whole 

body scan. The patient and the referring 

physician were informed of this event. 

The licensee concluded that no 

significant adverse health effect to the 

patient is expected. 

Cause(s)—The licensee identified four 

causes of the medical event: (1) The 

incorrect examination was scheduled in 

their Radiology Information System, (2) 

the patient had a prescription from the 

ordering physician, but did not make it 

available for verification, (3) the isotope 

for the incorrect exam was ordered 

without verifying the prescription, and 

(4) the technologist involved in the 

administration did not recognize the 

error when the written directive was 

presented. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee implemented 

corrective actions by providing 

counseling and re-training to the 

hospital personnel involved in the 

medical event and notified hospital 

personnel that iodine-131 and iodine123 studies must be verified prior to 

scheduling patients for these types of 

procedures. In addition, the 

technologists have been instructed to 

visually verify the authorized user 

physician’s order on the written 

directive before ordering the 

radioisotope and the technologist and 

radiologist will review the written 

directive prior to patient administration. 

State—The State conducted an 

investigation and reviewed the 

licensee’s corrective actions and found 

the corrective actions to be adequate. 

* * * * * 

AS08–04 Medical Event at Southern 

Baptist Hospital of Florida in 

Jacksonville, Florida 

Date and Place—January 24, 2008, 

Jacksonville, Florida. 

Nature and Probable Consequences— 

Southern Baptist Hospital of Florida 

(the licensee, doing business as Baptist 

Medical Center) reported that a patient 

received 173.9 MBq (4.7 mCi) of iodine131 for an uptake scan, instead of the 

intended iodine-123 for the same 

procedure. The administration of 173.9 

MBq (4.7 mCi) of iodine-131 resulted in 

the patient receiving a dose of 61 Gy 

(6,100 rad) to the thyroid and a whole 

body effective dose equivalent of 180 

cGy (180 rad). An authorized user 

physician gave a verbal order to a nurse, 

who wrote the order for an iodine-123 

uptake scan. The nurse incorrectly 

scheduled an iodine-131 uptake scan 

and the authorized user physician did 

not review the order. On January 16, 

2008, the authorized user physician 

reviewed the results of the iodine-131 

uptake scan and identified that the 

wrong isotope had been used in the 

procedure. The patient and the referring 

physician were informed of this event. 

The licensee concluded that no 

significant adverse health effect to the 

patient is expected. 

Cause(s)—The cause of the medical 

event was the authorized user 

physician’s failure to write a written 

directive and failure to review the order 

for the procedure. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee implemented 

corrective actions by rewriting its 

procedures such that all written 

directives will be completed and 

reviewed by the authorized user 

physician prior to the administration to 

patients. 

State—The State conducted an 

investigation and reviewed the 

licensee’s corrective actions and found 

the corrective actions to be adequate. 

* * * * * 

NRC08–04 Medical Event at Reid 

Hospital and Health Care Services in 

Richmond, Indiana 

Date and Place—February 27, 2008, 

Richmond, Indiana. 

Nature and Probable Consequences— 

Reid Hospital and Health Care Services 

reported that a medical event occurred 

during a brachytherapy seed implant 

procedure to treat prostate cancer. The 

written directive prescribed a total dose 

of 110 Gy (11,000 rad) to the patient’s 

prostate using 62 iodine-125 seeds as 

permanent implants. The licensee 

calculated that the patient received less 

than 15 Gy (1,500 rad) to the prostate 

and the region of the patient’s 

perineum, where the seeds were placed, 

received a dose of 55 Gy (5,500 rad). 

The patient and the referring physician 

were informed of this event. 

According to the licensee, the base of 

the prostate was misidentified through 

ultrasound, causing 37 of the prescribed 

62 seeds to be placed approximately 1 

cm to 2 cm below the prostate in the 

perineum. When it was recognized that 

the seeds were not in the prostate, the 

procedure was halted. The licensee 

physicians stated that the patient may 

develop possible complications, 

including fibrosis and necrosis of the 

tissue in the perineum, where the seeds 

were implanted. 

The NRC-contracted medical 

consultant agreed with the licensee’s 

dose estimate and stated it was unlikely 

that the patient would experience 

radiation-induced rectal wall necrosis or 

soft-tissue necrosis below the prostate in 

the perineum area, but that it was 

possible to have delayed fibrosis of 

some areas of the genital tract. The NRCcontracted medical consultant further 

stated that because no tissue necrosis 

had occurred one month after the 

medical event, tissue necrosis was very 

unlikely to occur. 

Cause(s)—The licensee determined 

the root cause of the medical event was 

the misidentification of the base of the 

prostate. Specifically, the prostate/ 

bladder interface was not identified 

properly using the ultrasound due to 

poor image quality. As a result, the 

needle used to implant the seeds was 

not located in the prostate during the 

implantation. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee’s corrective 

actions to prevent recurrence included 

revising its procedure for prostate seed 

implants to require that the needle 

location in the prostate be verified by xray imaging at the beginning of the 

procedure, prior to any seeds being 

implanted, and halting the procedure if 


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the location of the needle in the prostate 

cannot be verified with certainty. 

NRC—On July 11, 2008, NRC issued 

a Notice of Violation related to this 

event. 

* * * * * 

NRC08–05 Medical Event at Bon 

Secours Virginia Health Source in 

Midlothian, Virginia 

Date and Place—May 1, 2008, 

Midlothian, Virginia. 

Nature and Probable Consequences— 

Bon Secours Virginia Health Source 

reported that a medical event occurred 

during a high dose-rate (HDR) treatment 

for breast cancer using an iridium-192 

source with an activity of 165.4 GBq 

(4.47 Ci). The authorized user physician 

prescribed 10 fractions of 340 cGy (340 

rad) each to be administered using a 

balloon catheter technique. The licensee 

calculated that a portion of the target 

volume received a dose in the range of 

86 cGy (86 rad). In addition, a small 

volume of skin, at the catheter entrance 

into the patient, received a dose in the 

range of 1,142 cGy (1,142 rad). The 

patient and the referring physician were 

informed of this event. 

During the check source run for the 

first fraction, an HDR alarm interrupted 

the run. Rather than investigate the 

cause of the alarm, the physicist 

concluded that a 2 mm error had been 

made in the measurement of the 

catheter length and the alarm occurred 

because the check source hit the end of 

the catheter. The physicist adjusted the 

catheter length value at the treatment 

console from 1300 mm to 1280 mm, 

believing this to be a change of 2 mm, 

and the treatment was administered. 

Immediately following the first 

treatment, it was determined that the 

original catheter length measurement of 

1300 mm was correct and the length 

change made at the treatment console 

was 20 mm rather than 2 mm. As a 

result, the source dwell positions were 

20 mm from the intended locations and 

were closer than intended to the skin 

entry point of the HDR catheter. 

Subsequent HDR treatment fractions 

were administered as intended, with 

adjustments to the final two treatment 

fractions to assure that all areas of the 

target volume received an adequate dose 

over the course of the treatment. An 

NRC medical consultant concluded that 

no significant adverse health effect to 

the patient is expected. 

Cause(s)—The cause of the medical 

event was human error in (1) failing to 

investigate the cause of the HDR alarm 

and (2) adjusting the catheter length 

value at the console by 20 mm instead 

of the intended 2 mm. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee’s corrective 

actions taken to prevent recurrence 

included updating procedures to define 

steps that will be taken to resolve HDR 

device alarms. 

NRC—NRC performed a reactive 

inspection at the facility and issued a 

Notice of Violation for three violations 

of regulatory requirements on October 

10, 2008. 

* * * * * 

AS08–05 Medical Event at Lehigh 

Valley Hospital in Allentown, 

Pennsylvania 

Date and Place—July 17, 2008, 

Allentown, Pennsylvania. 

Nature and Probable Consequences— 

Lehigh Valley Hospital (the licensee) 

reported that a patient was prescribed a 

dose of 740 MBq (20 mCi) of iodine-131, 

for treatment of a thyroid condition, but 

instead was administered 2,775 MBq (75 

mCi). The licensee discovered the event 

within an hour of the administration 

and gave the patient 130 mg of 

potassium iodide, a blocking agent, to 

prevent the uptake of iodine-131 in the 

thyroid. As a result of the 

administration, next day measurements 

indicated that the patient had a 74 MBq 

(2 mCi) uptake to the thyroid and 370 

MBq (10 mCi) whole body retention, 

resulting in an approximate thyroid 

dose of 26 Gy (2,600 rad) and whole 

body effective dose equivalent of 8.7 

cGy (8.7 rad). The patient and the 

referring physician were informed of 

this event. The licensee determined that 

as a result of giving the patient 130 mg 

of potassium iodide, no significant 

adverse health effect to the patient is 

expected. 

Cause(s)—The cause of the medical 

event was human error because the 

technologist accidentally switched the 

doses between two patients. 

Actions Taken To Prevent Recurrence 

Licensee—The licensee implemented 

corrective measures by modifying 

current procedures involving the 

administration of radiopharmaceuticals. 

State—The State conducted a followup inspection on August 21, 2008, to 

ensure that the licensee’s actions taken 

to prevent recurrence had been 

implemented and issued a Notice of 

Violation. 

Dated at Rockville, Maryland, this 29th day 

of May 2009. 

For the U.S. Nuclear Regulatory 

Commission. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. E9–13300 Filed 6–5–09; 8:45 am] 

BILLING CODE 7590–01–P 

SMALL BUSINESS ADMINISTRATION 

Business Loan Program Temporary 

Eliminations/Reductions in Fees 

AGENCY: U.S. Small Business 

Administration (SBA). 

ACTION: Notice and request for 

comments. 

SUMMARY: This Notice formalizes the 

implementation of Section 501 of the 

American Recovery and Reinvestment 

Act of 2009. Section 501 authorizes SBA 

to temporarily reduce or eliminate 

certain SBA business loan program fees 

in the 7(a) Loan Program and the 504 

Certified Development Company 

Program. These fee changes are 

intended to promote economic recovery 

by providing economic relief to 

America’s small businesses and 

encouraging lenders to make small 

business loans. While these changes 

have been implemented and are underway, this Notice contains the key 

provisions of SBA’s implementation of 

Section 501 in formal guidance and 

requests public comment. 

DATES: Effective Date: This Notice is 

effective June 8, 2009. 

Applicability Dates: This Notice 

applies to 7(a) loans approved by SBA 

or issued loan numbers for delegated 

lender loans by SBA, on or after 

February 17, 2009 and to 504 loans 

approved by SBA, pending approval at 

SBA, or issued loan numbers for 

delegated CDC loans by SBA, on or after 

February 17, 2009, until funds 

appropriated for Section 501 are 

exhausted. 

Comment Date: Comments must be 

received on or before July 8, 2009. 

ADDRESSES: You may submit comments, 

identified by SBA docket number SBA– 

2009–0001 by any of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Recovery Act Comments— 

Office of Financial Assistance, U.S. 

Small Business Administration, Suite 

8300, 409 Third Street, SW., 

Washington, DC 20416. 

• Hand Delivery/Courier: Grady 

Hedgespeth, Director, Office of 

Financial Assistance, U.S. Small 

Business Administration, 409 Third 

Street, SW., Washington, DC 20416. 

SBA will post all comments on 

www.regulations.gov. If you wish to 

submit confidential business 

information (CBI) as defined in the User 

Notice at www.regulations.gov, please 

submit the information to Grady 

Hedgespeth, Director, Office of 

Financial Assistance, U.S. Small 


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