EA-97-284 - Centre Community Hospital

July 8, 1997

EA 97-284

Mr. Lance Rose, President
Centre Community Hospital
1800 East Park Avenue
State College, Pennsylvania 16803-6797

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-03198/97-001)

Dear Mr. Rose:

This refers to the NRC inspection conducted on January 22-23, 1997, at your facility in State College, Pennsylvania, to determine whether activities authorized by your NRC licenses were conducted safely and in accordance with NRC requirements. The inspection was continued in the NRC Region I and Headquarters offices until May 8, 1997, to review the results of an NRC consultant report submitted in March 1997 to determine whether a misadministration occurred at your facility. As described in the NRC inspection report which was sent to you on June 17, 1997, one apparent violation of NRC requirements was identified during the inspection. The NRC also concluded that a misadministration occurred at your facility. On June 26, 1997, a closed, transcribed Predecisional Enforcement Conference was conducted with you and members of your staff to discuss the violation, its cause, and your corrective actions.

Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involves the use of iridium-192 in a High Dose Rate (HDR) afterloader for surface treatment of skin cancer without your NRC license authorizing such use. Your license states that the HDR unit may be used for the treatment of humans only for interstitial, intracavitary, or bronchial therapy. The license does not authorize the use of the HDR for topical skin treatments.

The NRC is concerned that you continued to use the HDR unit for topical skin treatments even after you became aware that such treatments might not be permitted under your license. Your Radiation Safety Committee (RSC) meeting minutes, dated January 17, 1997, indicate that RSC personnel questioned whether the use of the HDR for skin treatment was authorized by the license. Your Radiation Safety Officer (RSO) stated that on November 2, 1996, he spoke with an NRC inspector and requested clarification regarding whether skin treatment was permitted under your license. This request for clarification was documented in a letter from you to the NRC, dated November 4, 1996. Although you did not receive a response to your November 4, 1996 letter, you continued such treatments without first receiving clarification from the NRC.

Since this treatment was not authorized by your license, this violation has been categorized in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III. The violation is of additional concern since it also contributed to a misadministration at your facility. Specifically, during a topical HDR treatment for skin cancer, on December 20, 1996, an apparent shift of the source position occurred. Although the right nasolabial fold of a patient was the intended treatment site during this seventh, of eleven planned fractional treatments, the shift in the source caused an unintended dose to the right side of the patient's cheek, resulting in a misadministration at the facility.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Your facility has not been the subject of escalated enforcement actions within the last two years; therefore, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective action is warranted because they were both prompt and comprehensive. These actions, which were noted in the inspection report and/or at the conference, included, (1) stopping all treatments of skin with the HDR; and (2) submitting an amendment request to the NRC seeking approval for such use.

Therefore, to emphasize the importance of prompt correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in a civil penalty.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should also confirm the commitments you made at the conference, to immediately contact the NRC and receive appropriate NRC clarification whenever you have any questions concerning your licensed activities and compliance with NRC requirements. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure, will be placed in the NRC Public Document Room (PDR).

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 030-03198
License No. 37-13681-01

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION

Centre Community Hospital State College, Pennsylvania

Docket No. 030-03198 License No. 37-13681-01 EA 97-284

During an NRC inspection conducted on January 22-23, 1997, of the licensee's facility in State College, Pennsylvania, and continued in the NRC Region I and Headquarters offices until May 8, 1997, to review the results of a consultant report as to whether a misadministration occurred at the facility, a violation of NRC requirements occurred. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the particular violation and is set forth below:

10 CFR 30.3 requires, in part, that except for persons exempted, no person shall possess or use byproduct material except as authorized by a specific or general license issued pursuant to Title 10, Chapter 1, Code of Federal Regulations.

License Condition 9.7 of License No. 37-13681-01, dated April 28, 1994, authorizes use of the High Dose Rate afterloader device for interstitial, intracavitary, or bronchial therapy.

Contrary to the above, from December 2, 1996 to January 6, 1997, Centre Community Hospital used iridium-192 in a High Dose Rate afterloader for surface treatment of skin cancer without its NRC license authorizing such use. (01013)

This is a Severity Level III violation (Supplement V).

Pursuant to the provisions of 10 CFR 2.201, Centre Community Hospital is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an Order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Because your response will be placed in the NRC Public Document Room (PDR), to the extent possible, it should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

Dated at King of Prussia, Pennsylvania
this 8th day of July 1997