EA-03-147 - Lankenau Hospital

August 21, 2003

EA 03-147

Gail Egan
President
Lankenau Hospital
100 Lancaster Avenue
Wynnewood, PA 19096

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-03098/2003-001)

Dear Ms. Egan:

This refers to the NRC inspection conducted on July 22, 2003, at your facility located in Wynnewood, Pennsylvania, to review the activities authorized by your NRC license. As described in the NRC inspection report enclosed with this letter, one apparent violation of NRC requirements was identified during the NRC inspection. The violation involved the failure to control licensed material at your facility for a period of 60 to 90 minutes after the material was delivered to your facility in December 2001. Although not required by NRC regulations, your staff subsequently sent a report to the NRC, dated July 23, 2003, that described the incident and your corrective actions.

On August 5, 2003, Ms. Pamela Henderson of the NRC Region I staff, held a telephone conversation with Ms. Barbara Giacomelli of your staff, indicating that the NRC did not need any additional information to make an enforcement decision regarding the violation. However, Ms. Henderson provided your staff an opportunity to attend a predecisional enforcement conference or to provide a written response prior to the NRC determining appropriate enforcement action in this case. During that conversation, Ms. Giacomelli declined the opportunity to attend a conference or to provide a written response.

Based on the information developed during the inspection and a review of your July 23, 2003 report, the NRC has determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. This violation involved the failure to maintain control of two drums with source trains containing 24 seeds of iridium-192 with a total activity of approximately 760 millicuries. The violation occurred when the drums containing the material were delivered to the wrong area of your facility by a courier. A researcher accepted and signed for the material and directed the courier to place the drums in an adjacent laboratory that was occasionally used to store other licensed material. The researcher locked the door (properly labeled with a "Radioactive Materials" sign) and left the material in the laboratory. A second researcher returned to the laboratory and discovered that the material was intended for another department within your facility. The second researcher contacted a medical physicist (the intended recipient) in the Department of Radiation Oncology and told him that the package was in the laboratory. However, the second researcher had to leave the area, so she left the laboratory unlocked so the medical physicist could retrieve the material about one hour later. As a result, the violation occurred.

Although the material remained in the laboratory the entire time it was unsecured, and it was unlikely that unauthorized persons came into direct contact with the material, this violation is of concern to the NRC because (1) the failure to control radioactive material could result in the loss or unauthorized transfer of the material; and (2) such sources can result in substantial unintended radiation dose to an individual if the source packages were opened or were placed in direct contact with an individual for an extended period of time. Therefore, this violation is categorized 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 $3,000 is considered for a Severity Level III violation involving the loss of control of radioactive material with this level of radioactivity. Because your facility has not been the subject of 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.C.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) educating personnel in the facility regarding acceptance of packages not intended for their work area; (2) working with the vendors for the Department of Radiation Oncology to design better shipping labels that clearly indicate the intended recipient; and (3) instructing the second researcher involved with the incident regarding the appropriate control of radioactive material.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation with no civil penalty for this Severity Level III violation. However, you should be aware that significant violations in the future could result in a civil penalty. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

Based on the results of this inspection, the NRC has also determined that one additional Severity Level IV violation of NRC requirements occurred. The violation involved the failure to perform adequate surveys to identify an iodine-125 seed on the operating room floor following an implant procedure. Since you identified and corrected this violation, it is being treated as a Non-Cited Violation (NCV), consistent with Section VI.A of the Enforcement Policy. This NCV is fully described in the subject inspection report.

The NRC has concluded that information regarding your corrective actions taken and planned to correct the violations and prevent recurrence have been described as documented in this letter and your letter dated July 23, 2003. 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. We appreciate your cooperation with us in this matter.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response (if you choose to provide one) will be made available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library.

		Sincerely,
		/RA/ George C. Pangburn Acting For
		Hubert J. Miller Regional Administrator

Docket No. 03003098
License No. 37-07905-04

Enclosures:
1.Notice of Violation
2. NRC Region I Inspection Report 030-03098/2003-001

cc w/encl:Commonwealth of Pennsylvania

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ENCLOSURE

NOTICE OF VIOLATION

Lankenau Hospital Wynnewood, Pennsylvania

Docket No. 030-03098 License No. 37-07905-04 EA 03-147

During an NRC inspection conducted on July 22, 2003, one violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violation is set forth below:

10 CFR 20.1801 requires that the licensee secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 requires that the 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, on December 17, 2001, the licensee did not limit access to two drums containing 24 seeds containing 763 millicuries of iridium-192 located in a laboratory at the facility located in Wynnewood, Pennsylvania, which is an unrestricted area, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, the licensee's staff left the material unattended in an unlocked laboratory for a period of approximately 60 to 90 minutes.

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

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 are already adequately addressed on the docket in the NRC letter transmitting this Notice. Therefore, no response to this Notice is required. 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, EA 03-147" 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.

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. ADAMS is accessible from the NRC Web site at the Public NRC Library.

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

Dated this 21st day of August 2003