Ad% University Medical Center at Princeton

University Medical Center

Ad%

at Princeton

Princeton lilethCare System

Redefining Care.

U.S. Nuclear Regulatory Commission

ATTN: Document Control Desk

Washington, DC 20555

Reply to Notice of Violation:

License No. 29-06750-01

Docket No. 03002489

This is to inform you that we are contesting our Certificate of Violation. We contest on the grounds

that the University Medical Center at Princeton has a well established electronic signature system in

place with excellent safeguards in place that have functioned here for computerized Physician order

entry and we believe it is a safe and effective method for the written directive.

Princeton

fleathCare

Syrem:

Access;to the'electronica'record'is very'restricted. One needs the following'to gain access to the

6lectr-6ic`,e'cbrd'^nd lathorlzetW'administration of a radionuclide requiring the use of a written

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University

Medical

Center at

Princeton.

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Princeton

}Ouse

Behavioral

Health

Merwick

Rehlab

Hospital &

Nursing

Care

Princeton

jlomeCare

Serices-

Princeton

Surgical

Center

Princeton

Fitness

& Weliness

Center

Username

Unique Access Code

Unique Password that is changed every 180 days

Once.a! the cmmputerl screen for the written directive, the physician enters information including

(adionuclide( anc:osage. The authorized user must accept the entry by way of a keystroke. Upon

completion of the correct keystroke, the authorized user's name appears on the screen of the written

directive. This serves as the electronic signature.

The.se;witten directives can be audited for up to three years after they are entered and the authorized

user can make revisions to the written directive

There are no guidelines from the NRC for electronic signature. But we believe that we have a safe

and effective method, using established CPOE procedures for written directives for 1131 treatments.

Sincerely,,-;

-Z;Nr:

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ion fib 1-I

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diaertiBerge,.

Se itSety

o2Officer

Princeton

HealthCare

System

Foundation

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as) th--1eJi@riel

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1OCFR35.5 does allow for records to be stored electronically as long as'there are adequate

safeguards to prevent tampering. We believe that we meet this condition.

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on tret I Priceton, NJ 08540 1 Tel: 609.497.4000 1 Fax: 609.497.4991

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.US.Nuclear Regulatory Commission

ATTN: Document Control Desk

Washington, DC 20555

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