EA-97-005 - Lower Bucks Hospital

May 27, 1997

EA 97-005

Mr. Nathan Bosk
Chief Executive Officer
Lower Bucks Hospital
Bath Road at Orchard Avenue
Bristol, Pennsylvania 19007

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $2,750 (NRC Inspection Report No. 070-02792/97-001)

Dear Mr. Bosk:

This letter refers to the NRC inspection conducted on December 12, 1996, at Nazareth Hospital in Philadelphia, Pennsylvania; on December 30, 1996, at waste facilities located in Morgantown and Allentown, Pennsylvania; and on January 9, 1997, at Lower Bucks Hospital in Bristol, Pennsylvania. The inspection was conducted to review the circumstances associated with the loss of control of a nuclear pacemaker (containing approximately 4.8 curies of plutonium-238) that had been implanted in a patient at your facility in 1978. The inspection was continued in the NRC Region I office through April 9, 1997, to review the results of analyses performed on samples taken from the Morgantown and Allentown, Pennsylvania waste facilities on December 30, 1996. These analyses were performed to determine whether the pacemaker had been damaged resulting in contamination at these locations. The sample results did not provide any evidence of contamination.

During the inspection, three apparent violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated May 2, 1997. On May 13, 1997, a predecisional enforcement conference was conducted with you and members of your staff to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be forwarded to you by separate correspondence.

Based on the information developed during the inspection, as well as information provided during the enforcement conference, the three violations are being cited and are described in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice), and the circumstances surrounding them are described in detail in the subject inspection report.

In 1978, a patient was implanted with a nuclear pacemaker by staff at Lower Bucks Hospital (LBH) as authorized by LBH's NRC license. The pacemaker was explanted at Nazareth Hospital on October 31, 1996, after the patient had expired. Although you were notified on November 2 or 3, 1996, that the patient had expired and that the pacemaker had been explanted, you did not contact the NRC within 24 hours, which constitutes one of the three violations. Also, on December 10, 1996, you were notified by a representative of Nazareth Hospital that the pacemaker could not be located and was assumed lost. Although you had contacted the supplier of the pacemaker to retrieve the pacemaker and properly dispose of it, you did not communicate effectively with Nazareth Hospital, to ensure appropriate control and disposal of the pacemaker. These failures resulted in two additional violations of NRC requirements.

Furthermore, during the inspection, the NRC learned of two additional instances (January 5, 1981 and September 18, 1983), in which pacemakers were buried with patients, and one additional instance in which the pacemaker was not returned to the supplier (August 1987). All three of these occurrences are similar to an occurrence at your facility in 1987 in which two pacemakers were buried with patients after the patients had expired. As the hospital that had initially implanted the pacemakers, as authorized by your NRC License No. SNM-1800, you were responsible for taking appropriate and timely action to ensure proper retrieval and disposal of pacemakers. This did not occur. Given the significance of improper disposal of this material, the violations have been classified in the aggregate as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility has not been the subject of an escalated enforcement action within the last two years or two inspections, 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. These actions, which were described during the enforcement conference, included: (1) hiring a consultant physicist after the December 1996 notifications in an attempt to locate the pacemaker, although such attempts were unsuccessful; (2) planned revision of procedures to include physical retrieval of sources, including during off hours, for explants performed in locations nearby; (3) plans to have a member of the Radiation Safety Committee provide quarterly training on procedures to all personnel who may be contacted regarding a pacemaker explant; and (4) plans to have the performance of this training reported during the RSC meetings. However, credit for corrective actions is not warranted because your corrective actions, at the time of the enforcement conference, were not considered sufficiently prompt and comprehensive to warrant such credit. For example, although notified on December 10, 1996, that the pacemaker was missing, your contractor's attempts to locate and retrieve the pacemaker were not taken until December 20, 1996. Also, procedure modifications, including a checklist for the person following the progress of the return of explanted pacemakers to the supplier, were still in draft form at the time of the enforcement conference, and did not address your stated intention to physically retrieve pacemakers explanted in the future at locations nearby.

Therefore, to encourage appropriate attention to your licensed program, as well as prompt and comprehensive correction of violations, I have been authorized to propose a civil penalty in the amount of $2,750 for the violations described in the enclosed Notice.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. 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, its enclosure, and your response will be placed in the NRC Public Document Room (PDR).

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 070-02792
License No. SNM-1800

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
Commonwealth of Pennsylvania

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Lower Bucks Hospital Bristol, Pennsylvania

Docket No. 070-02792 License No. SNM-1800 EA 97-005

During an NRC inspection conducted between December 12, 1996 and April 9, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG 1600, the NRC proposes a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282 and 10 CFR 2.205. The violations and associated civil penalty are set forth below:

A. 10 CFR 20.1801 requires that a licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that a licensee control and maintain constant surveillance of licensed material that is in a controlled or unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, controlled area means an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason; and unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, the licensee neither controlled nor maintained constant surveillance of licensed material which was in an unrestricted area. Specifically, a Coratomic Model C-101 nuclear pacemaker (containing a sealed source of approximately 4.8 Curies of plutonium-238) was explanted on October 31, 1996 at Nazareth Hospital in Philadelphia, Pennsylvania, and the licensee was informed of the explantation on November 2 or 3, 1996. However, the licensee did not control nor maintain constant surveillance of licensed material in that it did not attempt to directly recover the source until it was reported missing to them on December 10, 1996.

B. 10 CFR 20.2001 requires that the licensee dispose of licensed material only by certain specified procedures. License Condition 15 of NRC License No. SNM-1800 requires that the licensee continue patient follow-up and replacement procedures for nuclear pacemakers during the life of a patient, and follow procedures for recovery and authorized disposal of the nuclear pacemaker by return to the manufacturer upon the death of a patient.

Contrary to the above,

1. at some time between November 1, 1996 and November 19, 1996, licensed material, for which the licensee was responsible, was disposed by unauthorized means. Specifically, on October 31, 1996, a nuclear pacemaker (containing approximately 4.8 curies of plutonium-238) which was implanted at the licensee's facilities in 1978, was explanted from a patient at Nazareth Hospital in Philadelphia, Pennsylvania, and although the licensee was notified of the explantation on November 2 or 3, 1996, the pacemaker was not properly disposed of as required by the procedures specified in NRC License No. SNM-1800.

2.*1 a review of the records from the supplier of the pacemakers indicates that two additional deceased patients were buried with their pacemakers and one pacemaker was never returned to the supplier from a funeral home. Specifically,

a. a Coratomic Model C-101, SN 1055 was buried with a patient on January 5, 1981,

b. a Coratomic Model C-101, SN 1017 was buried with a patient on September 18, 1983, and

c. a Coratomic Model C-101, SN 1015 was explanted from a patient on August 24, 1987, and never returned to the supplier.

C. Condition 13 of NRC License No. SNM-1800 requires, in part, that the licensee notify NRC Region I within 24 hours of the occurrence of the death of any nuclear pacemaker patient.

Contrary to the above, the licensee did not notify the NRC Region I within 24 hours of the death of nuclear pacemaker patients. Specifically,

1. a nuclear pacemaker patient died on October 31, 1996 at Nazareth Hospital, Philadelphia, Pennsylvania, and although the licensee was informed of the death of the patient on November 2 or 3, 1996, the licensee did not notify NRC Region I until December 11, 1996.

2.* a review of the records of the supplier of the pacemakers indicated, at least, two additional examples of the failure to notify NRC Region I of the death of pacemaker patients as the patients were buried with their pacemakers.

These violations have been categorized in the aggregate as a Severity Level III problem (Supplements VI).
Civil Penalty - $2,750

Pursuant to the provisions of 10 CFR 2.201, Lower Bucks Hospital is required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each alleged violation: (1) admission or denial of the alleged violation, (2) the reasons for the violation if admitted, and if denied, the reasons why, (3) the corrective steps that have been taken and the results achieved, (4) the corrective steps that will be taken to avoid further violations, and (5) the date when full compliance will be achieved. 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 why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the Licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violation listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.B.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the Licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234c of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region I.

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 27th day of May 1997

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¹ These examples (marked with an asterisk) occurred beyond the five year statute of limitations period for assessing penalties (28 USC 2462) and are not considered for purposes of determining the civil penalty.