EA-98-555 - Washington Hospital Center

March 31, 1999

EA 98-555

Joyce E. Jonson, D.Sc.
Senior Vice President, Nursing and Patient Care
Washington Hospital Center
110 Irving Street, N.W.
Washington, DC 20010-2975

SUBJECT:   NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $5,500
                  (NRC Inspection Report Nos. 070-01500/98-001 and 030-01325/98-004)

Dear Dr. Johnson:

This refers to the NRC inspection conducted on December 2-3, 1998, at your facility in Washington, D.C., to review the circumstances associated with the loss of a nuclear pacemaker, which you reported to the NRC on November 30, 1998. The inspection was continued in the Region I office until December 22, 1998, to review additional information provided to the NRC, subsequent to the onsite inspection. As described in the NRC inspection report sent to you on January 6, 1999, several apparent violations of NRC requirements were identified during the inspection. On February 8, 1999, a predecisional enforcement conference was conducted with you and other members of the Washington Hospital Center (WHC) staff, including your recently appointed Acting Director of Radiation Safety, to discuss the apparent violations, their causes, and your corrective actions. A copy of the enforcement conference report was provided to you on February 25, 1999.

Based on the information developed during the inspection, and the information provided during the conference, two violations of NRC requirements are being cited. The violations 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. The more significant violation involved the loss of control of a nuclear pacemaker, which contained 2.8 curies (Ci) of plutonium-238 (Pu-238), when it was being prepared for shipment on September 15, 1998, to St. Jude Medical, a non-nuclear pacemaker company in Sylmar, California. The other violation involved the failure to make a timely report (i.e., within 30 days) by telephone after your staff identified that the pacemaker was lost or missing.

During the inspection, your staff informed the NRC inspector that the pacemaker was likely shipped through the normal postal service, without a return address on the package, and was intended to be sent to St. Jude Medical. However, that entity was not authorized, either by the NRC or an Agreement State, to receive it. At the predecisional enforcement conference, your staff presented a chronology of events similar to that presented to the inspector. Your staff also indicated that, due to the uncertainty as to whether the pacemaker was actually given to the U.S. Postal Service (USPS), your staff conducted an extensive search with radiation survey instruments at your facilities in an effort to find the pacemaker. However, these efforts did not locate the pacemaker.

The first violation is of particular concern to the NRC because: (1) the failure to control radioactive material resulted in the loss of the pacemaker; and (2) a breach of the nuclear pacemaker, within which the radioactive material is encapsulated, could result in a potentially significant intake of Pu-238. On March 26, 1999, you notified the NRC that the pacemaker had been located at the facilities of a NRC licensee in Minnesota. Although the pacemaker has apparently been found, the significance of the concern is not lessened because the potential still existed for a breach of the pacemaker and a significant intake of radioactive material. Therefore, Violation A has been classified as a Severity Level III violation in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, Revision 1.

In the past two years, three predecisional enforcement conferences were held with you for violations which occurred at your facility. The violations discussed at the prior two conferences resulted in the NRC issuance of $5,000 and $2,750 civil penalties on April 10, 1997, and April 28, 1998, respectively. In each of those cases, the failure to provide adequate training and instruction to staff was a contributing factor, as it was in a prior civil penalty issued to you on April 28, 1994, for other violations at your facility. In this case, the failure to train hazardous materials personnel in the applicable Department of Transportation (DOT) requirements may have been a root cause of the loss of control of the pacemaker.

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 been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for identification is warranted because the violation associated with the loss of control of the nuclear pacemaker was identified by your staff after they called St. Jude Medical to confirm whether the pacemaker had been received, and learned that it had not. Credit for corrective actions is warranted because your corrective actions, were considered prompt and comprehensive. These corrective actions include, but were not limited to: (1) placing a hold on all radioactive material shipments from your facility, except for the return of empty radiopharmaceutical containers to radiopharmacies, until a review of the shipping protocols could be completed; (2) contracting with a consultant from the National Institute of Health to review radioactive material shipping protocols; (3) providing the necessary hazardous material training to personnel, including the necessity to verify that the recipient has the appropriate license; (4) hiring of an Acting Director of Radiation Safety to oversee the restructuring of your Radiation Safety Department and the update of your Radiation Safety Manual; (5) posting two additional health physics positions to increase radiation safety staffing at the facility; and (6) conducting radiation surveys at your facility in an effort to find the pacemaker.

Given that credit is warranted for identification and corrective actions, the NRC would not normally propose a civil penalty in this case. However, I have decided, after consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Regulatory Effectiveness, to exercise enforcement discretion pursuant to Section VII.A.1 of the Enforcement Policy, and issue a Notice of Violation and Proposed Imposition of a Civil Penalty in the amount of $5,500 (twice the base amount for Violation A). Such discretion is warranted because: (1) this case involves the loss of radioactive material, which was intended to be shipped to an entity without verifying that the entity possessed an NRC license for receipt of such material; (2) your performance in this case was poor; and (3) your prior enforcement history has been particularly poor.

Based on the presumption that the pacemaker was shipped through the USPS, the NRC's January 6, 1999 inspection report identified eight additional apparent violations involving DOT requirements. While these apparent violations are not being cited in the Notice, they will be referred to the USPS for its review and action, as appropriate. Nevertheless, compliance with DOT requirements is intended to serve as safety barriers designed to prevent losses of radioactive material and to protect members of the public from inadvertent and potentially significant radiation exposures. DOT requirements include, but are not limited to, training, providing shipping papers, labeling of packages, and verifying (before shipping) that the transferee is authorized to receive radioactive material.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. As part of your response, you should address any actions taken, or planned to be taken, to ensure that future offsite shipments of radioactive material meet applicable DOT 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).

Docket Nos. 070-01500 and 030-01325
License Nos. SNM-1446 and 08-03604-03

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
District of Columbia

ENCLOSURE

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

During an NRC inspection conducted at WHC on December 2-3, 1998, and continued in the Region I office until December 22, 1998, 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:

Pursuant to the provisions of 10 CFR 2.201, Washington Hospital Center 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 31^st day of March 1999