EA-00-014 - Jersey City Medical Center

February 22, 2000

EA 00-014

Ms. Karen O'Keefe
Senior Vice President
Jersey City Medical Center
50 Baldwin Avenue
Jersey City, NJ 07304

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-02439/2000-001)

Dear Ms. O'Keefe:

This refers to the NRC inspection conducted on January 5, 2000, at your facility in Jersey City, New Jersey. The inspection was conducted to review licensed activities as they relate to radiation safety. During the inspection, seven apparent violations of NRC requirements were identified. The apparent violations were described in our inspection report sent to you on January 27, 2000. Four of the violations were cited in the Notice of Violation which accompanied the report. On February 15, 2000, a predecisional enforcement conference was held with you and other members of your staff to discuss the three remaining apparent violations, their causes, and your corrective actions. A copy of the enforcement conference report is attached.

Based on the information developed during the inspection and the information provided during the predecisional enforcement conference, three violations of NRC requirements are being cited. The violations are described in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first violation involved the failure to properly secure, on January 5, 2000, and on at least eight other occasions since July 1999, the Nuclear Medicine Department (NMD) hot laboratory where radioactive material was located. The failure to secure the NMD hot laboratory is important because licensed material (which included, at various times, quantities of iodine-131 greater than one millicurie, 87 millicuries of technetium-99m, dose calibrator reference sources, a gamma camera flood source, and radioactive waste) was stored in the laboratory, which is near an elevator routinely used by visiting members of the public and other workers at your facility. During these times, the door to the NMD hot laboratory was unlocked and the material was unattended.

The other two violations, also described in the attached Notice, are of concern because they contributed to the failure to maintain security of the radioactive material. The violations involved: (1) security personnel failing to follow facility procedures in that they allowed delivery couriers to place the packages of radioactive material in the laboratory without an escort; and (2) facility management failing to provide required training to facility personnel regarding the proper procedures for security of materials.

The NRC is also concerned that the failure to maintain security of radioactive material at the facility had been identified by your staff on a number of occasions. Nuclear Medicine Technologists had observed such occurrences and had informed the Manager of Radiology. Although the Manager of Radiology informed the Operations Manager of Security regarding the need for security staff to maintain appropriate security of material, these actions were not effective in preventing recurrence. Furthermore, the Radiation Safety Officer (RSO) or the Radiation Safety Committee (RSC) were not informed of the problem.

These findings represent weaknesses in the implementation of your program to secure radioactive material that could have resulted in an unplanned exposure to public or workers at your facility, particularly since the iodine-131 is a volatile substance with a high radiological risk. Therefore, the violations are categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures 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 for this type of licensee. Because your facility has not been the subject of an escalated enforcement action within the last two years, 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, at the time of the predecisional enforcement conference, were considered prompt and comprehensive after the violations were identified by the NRC. These actions include, but are not limited to: (1) immediately fixing the NMD hot laboratory door closure and locking mechanism; (2) training facility personnel regarding the proper procedure for security of radioactive material; (3) initiating an audit of the radiation safety program by an independent, outside auditor; (4) posting notices regarding the correct procedure for receipt of radioactive material; (5) adding a security representative (Assistant Director of Security) to the Radiation Safety Committee; and (6) mandating that the door to the NMD hot laboratory be closed at all times, even when a technologist is present.

Because the NRC encourages prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, which may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence, were already described during the enforcement conference, and are adequately addressed on the docket in this letter. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

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

		Sincerely,
		/RA/
		Hubert J. Miller Regional Administrator

Docket No. 030-02439
License No. 29-01663-01

Enclosure: Notice of Violation

cc w/encls:
John V. Cholankeril, M.D., Radiation Safety Officer
State of New Jersey

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ENCLOSURE

NOTICE OF VIOLATION
Jersey City Medical Center Jersey City, New Jersey		Docket No. 030-02439 License No. 29-01663-01 EA 2000-14

During an NRC inspection conducted on January 5, 2000, 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 violations are listed below:

A.	10 CFR 20.1801 requires that each licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. Contrary to the above, on January 5, 2000, and on eight other occasions between July 1, 1999, and December 31, 1999, the licensee did not secure from unauthorized removal or access licensed materials that were stored in controlled or unrestricted areas. Specifically;
	1.	On January 5, 2000, the inspector observed that the door to the Nuclear Medicine Department (NMD) hot laboratory, a controlled area, was left unsecured and licensed material (specifically, at various times, quantities of iodine-131 greater than one millicurie, 87 millicuries of technetium-99m, dose calibrator reference sources, a gamma camera flood source, and radioactive waste) was stored within the hot laboratory; and,
	2.	the inspector determined, through discussions with the licensee staff, that on at least eight occasions from July 1, 1999, through December 31, 1999, the door to the NMD Hot Laboratory was not secured and licensed material (including greater than one millicurie of iodine-131) was stored in the hot laboratory.
B.	10 CFR 35.21 (a) requires that the licensee, through the Radiation Safety Officer (RSO), ensure that the radiation safety activities are performed in accordance with approved procedures. The licensee's procedures for receiving and opening packages of licensed material and for training personnel who work in or frequent areas where byproduct material is used or stored are described in the application dated July 20, 1990, and letter dated January 25, 1993, and were approved by License Condition No. 14.
	1.	Item 10.6 of the application requires that the licensee establish and implement the model guidance for ordering and receiving radioactive materials that was published in Appendix K of Regulatory Guide 10.8, Revision 2. Appendix K of Regulatory Guide 10.8, Rev. 2 requires, in part, that the security guard on duty accept delivery of packages containing radioactive material that arrives during other than normal working hours. The Regulatory Guide also requires that the door to the NMD Hot Laboratory be unlocked, the packages placed within the hot laboratory, and the door relocked. Contrary to the above, as of January 5, 2000, the security guard on duty was not accepting delivery of packages containing radioactive material that arrived during other than normal working hours, and the hot laboratory door was not relocked after packages containing radioactive material were placed within the hot laboratory. Specifically, on January 5, 2000, and on eight other occasions identified by the licensee, the hot laboratory door was left open after the delivery of packages containing radioactive material between the hours of 5 am and 8 am and authorized licensee personnel were not maintaining constant surveillance of the hot laboratory. Also, shipments of packages containing radioactive material were delivered by couriers from a radiopharmacy to the hot laboratory, rather than to the security guard responsible for accepting the packages.
	2.	Item 8 of the application requires that the licensee implement and establish the model training program that was published in Appendix A to Regulatory Guide 10.8, Rev. 2. Table ATT 8.1 of the letter requires that security personnel be trained in the location of radioactive material storage and receipt procedures annually. Appendix A of Regulatory Guide 10.8, Rev. 2 requires, in part, that personnel be instructed before assuming duties with, or in the vicinity of, radioactive materials, during annual refresher training and whenever there is a significant change in duties, regulations, or the terms of the license. The instructions included, in part, the applicable regulations and license conditions, the licensee's in-house work rules, and each individual's obligation to report unsafe conditions to the RSO. Contrary to the above, as of January 5, 2000, personnel were not adequately instructed during annual refresher training on the applicable regulations and license conditions, the licensee's in-house work rules, and each individual's obligation to report unsafe conditions to the RSO. Specifically, security personnel were not provided with annual refresher training. As a result, they did not accept delivery of radioactive packages as required and the NMD Hot Laboratory door was left open after radiopharmacy couriers delivered packages to the NMD. Further, NMD personnel did not report unsafe conditions to the RSO regarding their identification that the NMD Hot Laboratory door was open upon their arrival at 8:00 am on eight separate occasions.

These violations constitute a Severity Level III problem (Supplement VI).

The NRC has concluded that information regarding the reasons for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence were adequately described during the enforcement conference on February 15, 2000, and are already adequately addressed on the docket in the NRC letter transmitting this Notice. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 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).

If you contest this enforcement action, you should also provide a copy of your response, with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

If you choose to respond, your response will be placed in the NRC Public Document Room (PDR). Therefore, to the extent possible, the response should not include any personal privacy or proprietary information so that it can be placed in the PDR without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 22nd day of February 2000