United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-96-047 - Clara Maass Medical Center

April 19, 1996

EA 96-047

Dr. Kathleen Scoble, Ed.D, R.N.
Vice President of Patient Services
Clara Maass Medical Center
1 Franklin Avenue
Belleville, New Jersey 07109

SUBJECT:   NOTICE OF VIOLATION
(NRC Inspection Report No. 030-02467/96-001)

Dear Dr. Scoble:

This refers to the inspection conducted on January 29-30 and February 13, 1996, at your Belleville, New Jersey facility. The purpose of the inspection was to determine the circumstances surrounding a therapeutic misadministration that occurred on January 16 and 17, 1996. The misadministration was reported to the NRC on January 17, 1996. Four apparent violations of NRC requirements identified during the inspection were described in the NRC inspection report transmitted with our letter to you dated March 1, 1996. On March 11, 1996, a predecisional enforcement conference was held with you and several members of your staff, to discuss the apparent violations, their causes, and your corrective actions. The Enforcement Conference Report will be sent to you by separate correspondence.

Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that two violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations include: (1) failure to include in your Quality Management Program written policies and procedures that meet the specific objective that any unintended deviation from a written directive is identified and evaluated, and appropriate action is taken; and (2) failure to secure licensed radioactive material from unauthorized removal.

On January 16, 1996, at 6:00 p.m., a member of the nursing staff identified that a patient's catheter containing six iridium-192 seeds (a brachytherapy implant) had moved and reported its movement to the radiation oncologist. The oncologist stated that he would check the catheter placement the next morning. The oncologist ordered that a chest x-ray be performed to locate the position of the implant and the x-ray was performed during the morning of January 17, 1996. The x-ray confirmed that the implant had moved out of the bronchus. After unsuccessfully attempting to reposition the catheter, the oncologist removed the catheter at 2:00 p.m. on January 17, 1996. These actions contributed to the patient receiving 240 centigray to the bronchial lesion (the intended target under the written directive), and depending on the position of the catheter, between 300 centigray and 7,500 centigray to the trachea (an unintended target). Delivery of a radiation dose to the wrong treatment site is defined in 10 CFR 35.2 as a misadministration. In addition, an evaluation of the dose received by the patient based on the mispositioned catheter had not been performed until after the dose had been delivered. Once the catheter moved, the source was no longer providing the intended dose to the intended target area thereby causing an unintended deviation from the written directive.

Given that there were opportunities to preclude this misadministration, since approximately twenty hours elapsed from the time of discovery of the dislodged catheter to the time of removal, failure to take timely action represents a programmatic weakness in the implementation of your quality management program. In addition to the recent misadministration, there were two other incidents involving brachytherapy procedures, one occurring during August 1993 and the second during September 1995. The NRC concluded that no violations were identified with respect to these incidents. However, records of the September 1995 incident reveal some uncertainty associated with the event specifically, whether the extruded brachytherapy source was completely or partially dislodged. This indicates a need for clear and concise documentation as well as the need to conduct thorough reviews when investigating incidents.

Since the violation involves a programmatic weakness in the implementation of a quality management program that resulted in a misadministration, the violation is classified at Severity Level III 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 $2,500 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last 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. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions include but are not limited to the following: (1) revising your written procedures to require an authorized user to respond within two hours to notification of a dislodged source and physically examine the patient; (2) updating nursing procedures; (3) promptly providing training to recently assigned oncology nursing staff; (4) revising forms utilized in connection with your Quality Management Program; and (5) providing annual inservice training to the oncology staff.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

An additional violation was identified by the inspector during the inspection which involves the failure to secure from unauthorized removal or limit access to more than 150 millicuries of technetium-99m that was located in the nuclear medicine hot laboratory while the door to the laboratory was propped open. This violation has been categorized as a Severity Level IV violation. As indicated in Supplement VI of the Enforcement Policy, violations of this type are normally categorized as Severity Level III. However, after careful consideration of the factors involved in this specific instance, including the amount of material, the type of isotope, the short period of time the violation existed, and the fact that the violation appeared to be an isolated occurrence that was promptly corrected, we have exercised our judgement under NRC Enforcement Policy and have categorized this violation as a Severity Level IV. Similar violations of this type in the future may result in additional enforcement action.

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 document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and any response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96-511.

Sincerely,

Thomas T. Martin
Regional Administrator

Docket No. 030-02467
License No. 29-03163-03

Enclosure: Notice of Violation

cc:
State of New Jersey


NOTICE OF VIOLATION

Clara Maass Medical Center
Belleville, New Jersey
Docket No. 030-02467
License No.29-03163-03
EA 96-047

During an NRC inspection conducted on January 29-30 and February 13, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions", NUREG-1600, the violations are listed below:

A.   10 CFR 35.32(a) requires, in part, that each licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.

Pursuant to 10 CFR 35.32(a)(5), the quality management program must include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is identified and evaluated, and appropriate action is taken.

Item 16 of the policy section of the licensee's nursing procedure for the care of patients with radioactive implants using sealed sources states that the Radiation Safety Officer (RSO) or radiation oncologist be notified immediately of an accidental removal of a radioactive implant.

Item D.10, Procedure Section, of the same nursing care procedure states that for accidental removal of a radioactive implant notify the radiation oncologist and the Radiation Safety Officer immediately.

Contrary to the above, as of January 17, 1996, the quality management program (QMP) did not include written policies and procedures to meet the specific objective that any unintended deviation from the written directive is evaluated, and appropriate action is taken, as evidenced by the following examples:

1.   The nursing procedure for the care of patients with radioactive implants using sealed sources provided, in two separate sections, conflicting information. Specifically, Item 16 requires notification of the RSO or the oncologist and Item D.10 requires notification of the RSO and the oncologist. Therefore, the procedure does not clearly specify the appropriate action to be taken with respect to notification when an accidental removal of a radioactive implant is identified. On January 16, 1996 a nurse identified that the position of the catheter within a patient had changed (removed from the treatment site) and the nurse notified the oncologist but did not notify the Radiation Safety Officer; and,

2.   The QMP did not include any written procedures to assure that an evaluation of the dose consequences to a patient from a dislodged implant was performed in order to take appropriate and timely action. (01013)

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

B.   10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in unrestricted areas. 10 CFR 20.1802 requires that the licensee control and maintain constant surveillance of licensed material that is in an unrestricted area and that is not in storage. As defined in 10 CFR 20.1003, unrestricted area means an area, access to which is neither limited nor controlled by the licensee.

Contrary to the above, on January 30, 1996, the licensee did not secure from unauthorized removal or limit access to more than 150 millicuries of technetium-99m located in its Hot Laboratory, an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. (01014)

This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Clara Maass Medical Center 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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at King of Prussia, Pennsylvania
this 19th day of April 1996

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