EA-97-246 - Overlook Hospital

August 21, 1997

EA No. 97-246

Mr. David H. Freed
Vice President and General Manager
Overlook Hospital
99 Beauvior Avenue
Post Office Box 220
Summit, New Jersey 07902-0220

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $2,750 (NRC Inspection Report No. 030-02471/97-001)

Dear Mr. Freed:

This letter refers to the NRC inspection conducted on May 7, 1997, at Overlook Hospital, Summit, New Jersey, of activities authorized by NRC License No. 29-03308-01. The inspection report was sent to you on June 27, 1997. The inspection was conducted to review the circumstances associated with the misadministration of iodine-131 to a patient at your facility. The misadministration occurred at your facility on May 5, 1997, and was reported to the NRC on May 6, 1997. During the inspection, two apparent violations of NRC requirements, which led to the misadministration, were identified. On July 16, 1997, an enforcement conference was conducted with you and other members of your staff to discuss the apparent violations, the causes, and your corrective actions. A copy of the Enforcement Conference Report was sent to you on July 30, 1997.

Based on the information developed during the inspection, as well as information provided during the enforcement conference, two 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. The violations involve (1) failure to prepare a written directive prior to administration of sodium iodide I-131 in quantities greater than 30 microcuries; and (2) failure to provide adequate supervision of licensed activities, in that the nuclear medicine technologist involved with the administration of the dose to the patient was not adequately instructed on the requirements of your Quality Management Program (QMP) regarding identification of patients, and completion of written directives, prior to administration.

The misadministration, which was reported to the NRC on May 6, 1997, involved a patient, who was scheduled to receive a 2 millicurie dose of I-131 for a whole body scan, but was mistakenly given a 7 millicurie dose intended for another patient. Both doses (one of which was ordered by your Nuclear Medicine Department, and the other of which was ordered by your Radiation Oncology Department) had been delivered to your facility from the radiopharmaceutical company on May 5, 1997, and had been stored in your Hot Lab. When the patient scheduled to receive the whole body scan arrived in the Nuclear Medicine Department, the nuclear medicine department technologist mistakenly picked up the 7 millicurie dose rather than the prescribed 2 millicurie dose. Although the technologist measured the dose in the dose calibrator, and handed the dose (with an incomplete dose administration form), to the authorized user, and reportedly told the authorized user that it was the 7 millicurie dose, the authorized user, nonetheless handed the dose to the patient who swallowed the dose. The authorized user indicated that he recognized the error after the dose was administered, but claims he did not hear the technologist tell him it was a 7 millicurie dose.

Along with the concern that there was a misadministration, the NRC is concerned that the required written directive was not completed, as required, prior to the administration of I-131. This failure to complete the directive was a contributing factor to the misadministration. The directive is to include the intended date of the administration, the patient's name, the dosage, the signature of the authorized user, and the date the written directive is signed. None of this was done. Even the patient's name was not entered on the written directive. During the inspection, it was also clear that the technologist was not sufficiently familiar with your QMP in that he did not know the correct definition of a misadministration. Clearly, the level of supervision provided by the authorized users over licensed activities, including the supervision of the technologist, was inadequate.

While this occurrence, is, in itself, significant, the misadministration takes on added significance because your facility has experienced two prior misadministrations of iodine-131 for whole body scans in 1990 and 1991. The NRC issued you a Notice of Violation and Proposed Imposition of Civil Penalty on December 12, 1991, for the second of the two misadministrations. Since the current violations also contributed to a misadministration, 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 been the subject of an escalated enforcement action within the last two inspections ¹, 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 not warranted because although the misadministration was identified by your staff, the violations that led to the misadministration were identified by the NRC. Credit for corrective actions was also considered. These corrective actions, which were described during the enforcement conference, included: (1) retraining of all authorized users and nuclear medicine technologists (NMTs) regarding QMP requirements; (2) development of a competency examination for all authorized users and NMTs, with a stipulation that no individuals use NRC material until the examination is passed; (3) a comprehensive review of the misadministration event and presentation of the results of this review to the hospital's Performance Review Committee and Medical Staff Executive Committee; (4) plans to conduct an independent annual audit of the radiation safety program by the hospital's Quality Assurance Program Committee; and (5) the development of specific sanctions for failure to comply with the QMP. Accordingly, credit for your corrective actions is deemed appropriate.

Therefore, to encourage appropriate attention to your licensed program, in particular, conformance to the QMP to preclude misadministrations at the facility, I have been authorized, after consultation with the Director of Enforcement, 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. 030-02471
License No. 29-03308-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
State of New Jersey

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Overlook Hospital Summit, New Jersey

Docket No. 030-02471 License No. 29-03308-01 EA 97-246

During an NRC inspection conducted on May 7, 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 35.32 (a) (1) (iv) requires that, prior to administration, a written directive is prepared for any administration of quantities greater than 30 microcuries of either sodium iodide I-125 or I-131.

Contrary to the above, on May 5, 1997, the licensee did not prepare a written directive prior to administration of quantities greater than 30 microcuries of sodium iodide I-131. Specifically, the licensee administered 7.27 millicuries of iodine-131 to a patient for whom a 2 millicurie dosage was prescribed, and did not prepare a written directive prior to the administration. (01013)

B. 10 CFR 35.25 (a) requires, in part, that the licensee instruct the supervised individual in the licensee's written quality management program, and requires the supervised individual to follow the written quality management program.

Contrary to the above, the licensee did not instruct a supervised individual in the licensee's written quality management program (QMP), and the licensee did not require the supervised individual to follow the written quality management program. Specifically, a nuclear medicine technologist involved in the administration of iodine-131 to a patient on May 5, 1997, was not adequately instructed on the QMP requirements regarding appropriate identification of a patient prior to administration, as well as the requirements for completion of a written directive prior to dose administration. (01023)

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

Pursuant to the provisions of 10 CFR 2.201, Overlook 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 21st day of August 1997

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^1.The Notice of Violation and Proposed Imposition of Civil Penalty issued to Overlook Hospital on December 12, 1991, was within the last two inspections (Reference: EA 91-163).