ML20149L518

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Discusses Insp Rept 30-03368/95-01 & Investigation Rept 4-95-027 on 950606-1221.Insp & Investigation Conducted in Response to Madigan Army Medical Ctr Identification of Medical Misadministrations Involving Brachytherapy Sources
ML20149L518
Person / Time
Site: 03003368
Issue date: 02/22/1996
From: Callan L
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To: Yu H
AFFILIATION NOT ASSIGNED
References
IA-95-037, IA-95-37, NUDOCS 9602270031
Download: ML20149L518 (5)


See also: IR 05000606/2012021

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UNITED STATES

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NUCLEAR REGULATORY COMMIS3lON

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611 RYAN PLAZA DRIVE, SUITE 400

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AR LINGTON, TEXAS 76011-8064

February 22, 1996

IA 95-037

Hung Yu, Ph.D.

[Home Address Deleted

10 CFR 2.790]

SUBJECT:

NRC INSPECTION REPORT 030-03368/95-01 AND NRC INVESTIGATION

REPORT 4-95-027

Dear Dr. Yu:

This refers to the NRC inspection and investigation which took place from

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June 6 through December 21, 1995, and to the transcribed predecisional

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enforcement conference conducted between the NRC and yourself on

January 17, 1996.

The inspection and investigation were conducted in response

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to the Madigan Army Medical Center (MAMC), your former employer, identification

of medical misadministrations involving the use of NRC-licensed brachytherapy

sources, which MAMC first reported to the NRC on June 2, 1995.

Based on preliminary findings of the inspection and investigation, the NRC

concluded that you had engaged in deliberate misconduct by:

(1) knowingly

providing to MAMC on June 2,1995, inaccurate information relating to a matter

material to the NRC, specifically the cause of the error that resulted in a

misadministration, in violation of 10 CFR 30.10(a)(2); and (2) deliberately

failing to conduct surveys of packages containing brachytherapy sources and

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deliberately making entries to MAMC records to show that you had conducted such

surveys, in violation of 10 CFR 30.10(a)(1). As a result, the NRC issued to

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you on September 18, 1995, an Order Prohibiting Involvement in NRC-Licensed

Activities (Effective Immediately) which prohibited you from participating in

NRC-licensed activities, pending further investigation and order by the NRC.

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During the January 17, 1996 conference, you admitted that you provided

inaccurate information to MAMC officials.

However, you denied that you were

trying to cover up the cause of the misadministrations.

In addition, you

stated that you were trying to "get rid of them [the radiation safety officer

and authorized user] out of the office" because:

(1) you wanted to continue

practicing the multidata training you had received on June 1, 1995; (2) you

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were in a very bad mood; and (3) you thought that the medical consequences of

the most recent misadministration was not important.

You also admitted that

you deliberately failed to conduct surveys of labelled packages containing

brachytherapy sources.

Furthermore, you admitted that you inappropriately made the judgment that the

clinical consequences of the most recent misadministration were not

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significant, rather than immediately informing the authorized user and RSO

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about the cause of the misadministration so that appropriate actions could be

taken.

You also stated that, as a result of your actions, you had learned a

very important lesson and would not engage in similar misconduct in the future.

Moreover, you stated that should you engage in NRC-licensed activities in the

future, you would study all computer manufacturer's manuals to ensure that

similar errors and misadministrations do not recur.

Based on the statements you provided the NRC during the transcribed conference,

we have concluded that you now:

(1) understand the unacceptability of your

actions; (2) realize the importance of providing the NRC complete and accurate

information; (3) recognize your attitude was inappropriate; and (4) appreciate

the need to comply with NRC requirements.

In addition, the NRC has concluded,

after conducting a predecisional enforcement conference with your former

employer on January 18, 1996, that your former employer bears some of the

responsibility for your actions because of its failure to provide you adequate

quality management program training.

Therefore, in view of your statements, the circumstances surrounding this case,

the five-month NRC prohibition, and the substantial disciplinary action,

i.e.,

suspension from work activities, taken against you by your former employer, the

NRC has determined that we should relax the September 18, 1995 order provided

that you certify, as noted on Page 4 of this letter, to the Commission that you

will become knowledgeable of and comply with all NRC requirements, should you

engage in NRC-licensed activities * in the future.

The NRC will relax the

order, and allow you to engage in NRC-licensed activities, upon receipt of this

letter with your signature and certification, under oath or affirmation.

You

should return the letter to Mr. James Lieberman, Director, Office of

Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North,

11555 Rockville Pike, Rockville, MD 20852-2738.

You will be notified by mail

when the order is relaxed.

You should note that you may be subject to significant civil or criminal action

if you exhibit similar conduct in any future NRC-licensed activity.

In accordance with Section 2.790 of the NRC's " Rules of Practice," Part 2,

Title 10, Code of Federal Regulations, records or documents compiled for

enforcement purposes are placed in the NRC Public Document Room (PDR). A copy

of this letter will be placed in the PDR with your home address removed.

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NRC-licensed activities include licensed activities of:

1) an NRC

licensee, 2) an Agreement State licensee conducting licensed activities in NRC

jurisdiction pursuant to 10 CFR 150.20, and 3) an Agreement State licensee

involved in distribution of products that are subject to NRC jurisdiction.

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If you have any questions, please contact Mr. Gary Sanborn at (817) 860-8222.

Sincerely,

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b Regional Administrator

cc:

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State of Washington

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I, Hung Yu, Ph.D., hereby certify that I have read the above letter and fully

understand its contents, and that, if 1 engage in the future in any NRC-

licensed activities, I will become knowledgeable of and comply with all

applicable NRC requirements, including the requirement to provide complete and

accurate information to both the licensee and NRC.

I also understand that

failure to meet NRC requirements may subject me to civil or criminal- sanctions.

Hung Yu, Ph.D.

Subscribed and sworn to (or affirmed) before me this _ day of

, 1996

Notary Public

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HQ DISTRIBUTION:

PUBLIC

SECY

CA

JTaylor, ED0

HThompson, DEDS

CPaperiello, NMSS

DCool, NMSS

LCamper, NMSS

JLieberman, OE

LChandler, OGC

JGoldberg, OGC

Enforcement Officers

RI, RII, RIII

JGilliland, OPA

PLohaus, OSP

LNorton, OIG

EJordan, AE0D

GCaputo, 01

NMamish, OE

NUDOCS

RIV DISTRIBUTION:

LJCallan

SCollins

GSanborn > EAFile

BHenderson; MHammond

CHackney; DKunihiro

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WBrown

RScarano; DChamber1ain

LHowell

CCain

FWenslawski

LWilliamson

MIS Coordinator

DNMS Files

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