Ok Medcal Center - Nuclear Regulatory Commission

ok Medcal Center

byMEMBER OFTHEM!RIDIAN HEALTHFAMILY

December 21, 2005

U. S. Nuclear Regulatory Commission Attention: Document Control Desk Washington, D.C. 20555

Subject: Reply to a Notice of Violation

Ocean Medical Center Brick, NJ

Docket No. 03020725 License No. 29-20690-01

During an NRC inspection conducted on November 8 and 9, 2005, two violations of NRC requirements were identified. In accordance with the NRC Enforcement Policy, the violations are listed below:

A. 10 CFR 35.40(a) requires, in part, that a written directive must be dated and signed by an authorized user before the administration of 1-131 sodium iodide greater than 30 microcuries.

Contrary to the above a written directive was not dated and signed by an authorized user before the administration of I- 131 sodium iodide greater than 30 microcuries. Specifically, on February 28, 2005, the licensee administered 105.9 millcuries of 1-131 sodium iodide without a written directive dated and signed by an authorized user.

Corrective Action:

Written directive will be dated and signed by an authorized user prior to administration.

Correct Steps to Avoid Further Violations:

Education and constant audit prior to administration

Compliance Date:

December 1, 2005

B. 10 CFR 35.633(a) requires, in part, that a licensee authorized to use a remote afterloader unit for medical use perform full calibration measurements on each unit following replacement of the source.

T. 732.840.2200

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Meridian Health Line 1.800.560.9990 *

425 Jack Martin Blvd. * Brick, NJ 08724

MERIDIAN HEALTH: jERSEY SHORE UNIVERSITY MEDICAL CENTER * OCEAN MEDICAL CENTER X RIVERVIEW MEDICAL CENTER * PARTNER COMPANIES

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10 CFR 35.633(b) requires, in part, that full calibration measurements include determination of the length of the source transfer tubes, timer accuracy and linearity over the typical range of use, and length of the applicators.

Contrary to the above, as of November 8, 2005, the licensee's full calibration measurements of the remote afterloader unit following replacement of the source did not include determination of the length of the source transfer tubes, timer accuracy and linearity over the typical range of use, and length of the applicators. Specifically, the licensee's full calibration following replacement of the source of September 1, 2005 did not include determination of these measurements.

Corrective Action:

1. A form has been developed for time accuracy and linearity over the typical range.

2. A form has been developed to verify length of the source transfer tubes and applicators. This form will also be used for checking the functions of the source transfer tubes, applicators and transfer tub-applicator interfaces. (See attachments)

Corrected Steps to Avoid Further Violations:

1. New policy and procedure to ensure compliance

2. Education and audits

Compliance Date:

December 1, 2005

If you have any further questions, please do not hesitate to contact me at (732) 840-3344.

Si cervi /t

ichar /'pstein, R.Ph., MBA Vicefesident, Operations

cc: P. Henderson - Region I Administrator

Robert Monaco, MD Radiation Safety Officer

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OCEAN MEDICAL CENTER VARIAN HDR SAEETY SURVEY AND CALIBRATION

25 / 6 Name:

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Signature: __

Source Receipt Survey and Inventory

b~c~eenqA (within 3 hours ofrecei t, ifduring business hours, or 3 hours from beginning ofnext day)

Meter.

|/A cMalibration date:

_____

M:

__

Battery (K __

Check source OK

nR/hr @1 meter: /hy jt0'7 v @ surfice: /C?. . // r

Source information entered in inventory formn

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Signature: r

Date:// 12 3 i 5

Varian Source Manufacturer Calibration Data (Attach original calibration certificate)

Model#:VS-2000 Serial#:

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Activity:

Ci

1 21 / >ffi2:00 PM CST

Safety Survey After Installation

Meter: 14 Dc n t/' A Calibration date: {3iTI Battery OK ___

Check source OK

(Background: o v 3

mRlhr)

Exposure rate near treatment unit with source retracted

Right Left

Front

Rear

Above Below Tolerance

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Source Cahlbration

VarianHDRMode1#:VariSoue200 Serial#: VS-32ISourceModel#:VS-2000 Serial#: Standard bmaging HDR-1000 Plus chamber S/N A023052 (4.691 x 10-4 Gym2 hranA1 ;calibrated: 9/30104) Standard imaging electrometer Model CDX-2000B S/N J023 104 (1.000 nA/Readig, calibrated: 9124/04) Activity conversion factor 248.1 Ci Gy' m2 h Run plastic tipped 100 cm catheter into bottom of chamber well Setting: Applicator length 100 an, Position 95 cm, dwell time 110 sec

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Position nA Reading

95 cm '73,. 05

95 cm

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95 cm

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Average

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Tenmp: 7-0 -qC Pressure: _'__6 nm Hg C,7=

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Date: I/V//oS Time of day. Average nA Reading * C, * Decay Factor * Cff x 104 * 1.000 * 248.1 = Activity (Ci)

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