ML20035A242

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Submits Info Re Actions Taken by Agreement State co-regulators & co-regulator Licensees as Result of Indiana, PA Radiation Accident & Source Wire Failure in Omnitron 2000 High Dose Rate Afterloader
ML20035A242
Person / Time
Issue date: 02/12/1993
From: Taylor J
NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
To: Rogers, Selin I, The Chairman
NRC COMMISSION (OCM)
References
NUDOCS 9303250039
Download: ML20035A242 (8)


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February 12, 1993 MEMORANDUM FOR:

The Chairman

. Commissioner Rogers Commissioner Curtiss Commissioner Remick Commissioner de Planque FROM:

James M. Taylor Executive Director for Operations

SUBJECT:

AGREEMENT STATE ACTIVITIES REGARDING ONCOLOGY SERVICES AFFILIATES AND OMNITRON USERS STATES This is to provide information to the Commission about the actions taken by the Agreement States' co-regulators and their i

licensees as a result of the Indiana, Pennsylvania radiation accident and the source wire failure in the Omnitron 2000 high dose rate afterloader.

The names of the Omnitron users and i

Oncology Services Corporation (OSC) affiliates were collected from information provided to the Commission by Omnitron and OSC.

.i Several additional users were identified by the Agreement State l

l radiation control programs who named Omnitron licensees not previously identified or which were in the license application process at the time of the event.

1 The information is current as of February 10, 1993.

A listing of licensees by Agreement State follows:

ALABAMA VALLEY REGIONAL CANCER CENTER

  • SHEFFIELD, AL f

Omnitron user.

l Voluntarily stopped using unit upon notification.

Presently, they are using the unit on a limited basis under i

the guidance of NRC's Bulletin and an amended license i

condition (survey of each. patient treated is required and records retention for 5 years).

Affiliated with licensees in MS,-TN and IL..

l ARIZONA f

2 GOOD SAMARITAN MEDICAL CENTER

  • PHOENIX, AZ f

Omnitron user.

i Presently using unit under NRC's Bulletin.

AZ conditioned l

license to reflect required changes.

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P The Commissioners 2

February 12, 1993 CALIFORNIA USC-KENNETH NORRIS, JR. CANCER HOSPITAL

  • LOS ANGELES, CA

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Omnitron user.

Licensee was contacted and sent in their procedures for review.

Licensee is using unit under the guidance provided in the NRC Bulletin.

An inspection is planned for the facility.

CA is planning a newsletter for all brachytherapy licensees.

FLORIDA TREASURE COAST RADIATION ONCOLOGY CENTER

The State visited the licensee in mid-December.

At that time the licensee appeared to be following all procedures and license conditions.

The licensee has volunteered to stop using the unit pending resolution of the safety issues.

The relationship of OSC to the licensee appears to be that of a " senior" partner.

All physicians, technicians meet FL's training and experience and licensing criteria to work i

at the facility.

MOUNT SINAI

  • MIAMI BEACH, FL Omnitron user.

t The State visited the licensee in mid-December.

Licensee has never used the device and volunteered not to use it until the safety issues are resolved.

GOOD SAMARITAN HOSPITAL CANCER CARE CENTER

  • WEST PALM BEACH, FL Omnitron user.

f The State visited the licensee in mid-December.

This is the only FL licensee using the Omnitron device at this time.

The licensee has adopted NRC's guidelines published in the Bulletin.

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The Commissioners 3

February 12, 1993 J. F. K. MEDICAL CENTER

  • ATLANTIS, FL i

Possible new omnitron user.

The State visited the licensee in mid-December to explain the situation.

Florida issued the license in January 1993.

The license will be hand delivered by FL in the next week or I

so.

At this time the licensee appears to be evaluating their purchase of the Omnitron unit.

GEORGIA EMORY UNIVERSITY HOSPITAL

  • ATLANTA, GA Omnitron user.

Tom Hill reported this unit to OSP in December.

It was apparently used once and is not currently in use.

The unit is scheduled to go to Grady Hospital in Atlanta.

A memorandum was sent by the State of GA to Pat McGinley (Emory University) recommending that the unit not be put in service pending the outcome of the safety issues.

LOUISIANA EAST JEFFERSON RADIATION TREATMENT CENTER

  • METAIRIE, LA ST FRANCIS CANCER TREATMENT CENTER
  • MONROE, LA Omnitron users.

Both licensees are working under the guidance provided in i

NRC's Bulletin and have submitted additional emergency procedures to LA.

ILLINOIS KANKAKEE RADIATION THERAPY

  • KANKAKEE, IL Omnitron user and OSC affiliate.

i Steve collins reported last week that the facility received license for an Omnitron ERD unit about one year ago.

They received the unit, however, when Omnitron applied to Illinois to install the source it was discovered that the LA license did not authorize tenporary job sites and the l

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The commissioners 4

February 12, 1993 l

installation was not allowed.

Omnitron went to LA to get-

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license amendment and has not yet come back to-Illinois at this time. IL contacted LA about the problem.

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ST JAMES HOSPITAL

  • CHICAGO HEIGHTS, IL Omnitron user.

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This licensee was identified by IL.

Has license for Omnitron unit.

No equipment installed.

NOTE:

IL does not know if this licensee is affiliated with Oncology Services.

j BETHESDA REGIONAL CANCER TREATMENT CENTER

  • CARBONDALE, IL BETHESDA CANCER CENTER
  • CARTERVILLE, IL These licensees are' reported to have affiliation with I

licensees in AL, MS and TN.

They are now accelerator facilities since their radioactive materials licenses were terminated some time ago.

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MARYLAND t

CHESAPEAKE REGIONAL CANCER CENTER

  • MECHANICSVILLE, MD OSC affiliate.

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l State has never received an application from this facility.

MGH CANCER TREATMENT CENTER

  • OLNEY, MD 4

7 MARYLAND GENERAL CANCER CENTER

  • BALTIMORE, MD l

ONCOLOGY CENTER AT RIVERSIDE'* BELCAMP, MD J,

OSC affiliates.

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Applications received, however, they have been put in " hold mode" pending resolution of the Omnitron' safety issues.

BCGH RADIATION ONCOLOGY CENTER

  • RANDALLSTOWN, MD i

Omnitron user and OSC affiliate.

Licensed to use Omnitron 2000.

Licensee volunteered to stop f

using unit upon notification by the State then changed their mind.

Presently, the licensee is under an order from MD i

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I

The Commissioners 5

February 12, 1993 radiation control program not to use the unit pending resolution of safety issues.

MISSISSIPPI BETHESDA CANCER CENTER-GREENVILLE

  • GREENVILLE, MS Omnitron user.

Licensee required to amend procedures to conform to NRC's guidance provided in our Bulletin.

Submitted procedures will be amended to their license in near future.

Technologist was sent to Omnitron for training in emergency procedures following the event.

Affiliated with AL, IL and TN licensees.

State has had concerns about the physician, Dr. Minetree, being "on site" during treatments.

To date the licensee performed well with the exception of failure to do leak tests and one occasion of the physician not being present during a treatment.

i USAF KEESLER AFB, BILOXI, MS Omnitron user.

State made a courtesy call to the RSO at the hospital to inform him of the Omnitron event.

NORTH CAROLINA ALBERMARLE REGIONAL ONCOLOGY CENTER

  • ELIZABETH CITY, NC OSC affiliate.

NC reported that this facility is a " registrant" for an x-ray treatment simulator and was unaware that the registrant may be operating an accelerator.

Robin Haden visited the facility February 8-9, 1993.

The findings are that the registrant was found to be operating an accelerator without a license.

Aside from the technical issue of not having a license, the program's health and safety requirements were found to be adequate.

The State is working with the licensee to get a license.

Additionally, it was discovered that this licensee had plans for a second accelerator facility in Laurinburg, NC that would have also been unlicensed.

The State is working with Siemens Corporation,-

the accelerator manufacturer, to prevent future incidents of this type.

Enforcement action is being considered.

The Commissioners 6

February 12, 1993 NEW YORK WESTCHESTER ONCOLOGY

  • YONKERS, NY Omnitron user and OSC affiliate.

The licensee volunteered to stop using the unit pending the outcome of the safety investigation.

The State has received a letter from the licensee confirming their action.

TENNESSEE BETHESDA CANCER CENTER-COOKEVILLE

  • COOKEVILLE, TN BETHESDA CANCER CENTER-TULLAHOMA,
  • TULLAHOMA, TN Omnitron users.

Affiliated with AL, MS and IL licensees.

At present, the licensees have voluntarily shut down.

This has been confirmed by letter to the State.

TEXAS BAYLOR COLLEGE OF MEDICINE-METHODIST HOSPITAL

  • HOUSTON, TX Omnitron user.

Licensee had voluntarily stopped using the unit after notification of the incident.

After developing new procedures they have requested permission to use the unit and the State has amended their license to reflect the changes a couple of days ago.

The licensee will notify NRC of their change in status.

Although the licensee used NRC's Bulletin for guidance, TX believes that the licensee provided an " aggressive" plan and assurances that go beyond that which Federal and State regulators would have required.

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February 12, 1993 NEW YORK WESTCHESTER ONCOLOGY

  • YONKERS, NY Omnitron user and OSC affiliate.

l The licensee volunteered to stop using the unit pending the outcome of the safety investigation.

The State has received a letter from the licensee confirming their action.

TENNESSEE BETHESDA CANCER CENTER-COOKEVILLE

  • COOKEVILLE, TN BETHESDA CANCER CENTER-TULLAHOMA,
  • TULLAHOMA, TN Omnitron users.

Affiliated with AL, MS and IL licensees.

At present, the licensees have voluntarily shut down.

This has been confirmed by letter to the State.

TEXAS BAYLOR COLLEGE OF MEDICINE-METHODIST HOSPITAL

  • HOUSTON, TX Omnitron user.

Licensee had voluntarily stopped using the unit after notification of the incident.

After developing new procedures they have requested permission to use the unit and the State has amended their license to reflect the changes a couple of days ago.

The licensee will notify NRC of their change in status.

Although the licensee used NRC's Bulletin for guidance, TX believes that the licensee provided an " aggressive" plan and assurances that go beyond that which Federal and State regulators would have required.

Originaltigind by James li.Tay!ct James M. Taylor, Executive Director for Operations cc:

SECY OCA Distribution: See next page.

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