ML20057C693

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Discusses Insp of License 50-19913-01 on 930817-19 & 24 & Forwards Notice of Violation.Failure to Test Dose Calibrator for Linearity & Geometry Dependence Prior to Use Is Repeat of Violations
ML20057C693
Person / Time
Site: 03019521
Issue date: 09/14/1993
From: Yuhas G
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To: Mahn E
KETCHIKAN GENERAL HOSP., KETCHIKAN, AK
Shared Package
ML20057C694 List:
References
NUDOCS 9309290271
Download: ML20057C693 (3)


See also: IR 05000199/2013001

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UNITED STATES

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REGION V

NUCLEAR REGULATORY COMMISSION

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1450 MARIA LANE

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WALNUT CREEK, CAUFORNIA 94596-5368

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SEP 141933

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Docket No.

030-19521

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License No.

50-19913-01

Ketchikan General Hospital

3100 Tongass Ave

Ketchikan, Alaska 99901

Attention:

Ed Mahn

Hospital Administrator

SUBJECT:

NOTICE OF VIOLATION

This refers to the inspection conducted by Mr. David D. Skov of this office on

August 17-19 and 24, 1993. The inspection included a review of activities

authorized for your facility in Ketchikan, Alaska. The inspection findings

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were discussed with you and other members of your staff on August 19, 1993.

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Subsequent discussions relative to the inspection were held with Mr. David

Smith by telephone on August 24, 1993. On September 8, 1993, the inspection

findings were reviewed with Dr. Lesko by telephone.

The inspection was an examination of the activities conducted under your

license as they relate to radiation safety and to compliance with the

Commission rules and regulations and the conditions of the license. The

inspection consisted of selective examinations of procedures and

representative records, interviews with personnel, and observations of

activities in progress. The purpose of the inspection was to determine

whether activities authorized by the license were conducted safely and in

accordance with NRC requirements.

Based on the results of this inspection, certain of your activities appeared

to be in violation of NRC requirements, as specified in the enclosed Notice t.;

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Violation (Notice). The failure to test a dose calibrator for linearity and

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geometry dependence prior to its use is a repeat of violations based on an NRC

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inspection in 1991, and the failure to include the signature of the Radiation

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Safety Officer (RS0) on certain dose calibrator test records and on certain

records of sealed source leak tests and physical inventories, is a repeat of

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violations following NRC inspections in 1991 and 1992. Additional violations

also included: (1) the failure to properly authorize the use of licensed

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material by a visiting physician authorized user, as required by 10 CFR 35.27(a); (2) the failure to conduct weekly radiation level surveys in areas

where radiopharmaceuticals and radiopharmaceutical waste is stored, as

required by 10 CFR 35.70(b); and (3) the failure to survey for removable

contamination once each week in all areas where radiopharmaceuticals were

routinely used and stored, as required by 10 CFR 35.70(e).

9309290271 930914

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Violation B in the attached Notice, involving t_he failure of the RSO to sign

certain records, would normally be a Severity Level V violation, but has been

classified as a Level IV violation based on repetitiveness'. Normally we would

also hold an enforcement conference for a second repeat violation, but since

it appears that these records were reviewed by your RS0 and Radiation Safety

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Committee, we have elected not to hold an enforcement conference in this case.

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Although significant improvements have been made in your licensed program

since the last inspection, the repeat and other violations indicate a lack of

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attention to NRC and license requirements and inadequate management control

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and oversight of your radiation safety program.

In addition to the need for

corrective action regarding the specific violations in the Notice, we are very

concerned about the implementation of your management control system that

permitted the violations to occur. There is a need for strong participation

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by management to ensure full compliance with NRC requirements in all areas of

your licensed program.

Because of our concerns, we have scheduled an early

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reinspection of your licensed program. 'You should be aware that any future

repetition of violations similar to that involved in this enforcement action

will result in an escalated enforcement which could include imposition of a

civil penalty or action against your license.

You are required to respond to this letter and should follow the instructions

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specified in the enclosed Notice when preparing your response.

You~r response

should document the specific actions taken and any additional actions you plan

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to prevent recurrence of these violations. Also, specifically describe what

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administrative controls will be established to improve the management

oversight of your licensed program to prevent violations of NRC requirements.

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After reviewing your response to this Notice, including your proposed

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corrective actions and the results of future inspections, the NRC will

determine whether further NRC enforcement action is necessary to ensure

compliance with NRC regulatory requirements.

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In accordance with 10 CFR 2.790 of the NRC's " Rules of Practice." a. copy of

this letter and its enclosures will be placed in the NRC Public Document' Room.

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The responses directed by this letter and the enclosed Notice are not subject

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to the clearance procedures of the Office of Management and Budget as required

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by the Paperwork Reduction Act of 1980, Pub. L. No.96-511.

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Sincerely,

G.L2 A--

Gregory P. Yuhas, Chief

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Radioact' e Materials Safety Branch

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Enclosure:

Notice of Violation

cc w/ Notice

Sister Monica Hearne

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Health & Hospital Services

1715 ll4th Ave. S.E. # 110

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Bellevue, Washington 98004

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Docket File

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Inspection File

G. Cook

R. Huey

B. Faulkenberry

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State of Alaska

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M. Smith

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