EA-97-006 - Kennedy Memorial Hospital
Joseph W. Devine, Vice President, Hospital Services
Kennedy Memorial Hospitals - University
18 East Laurel Road
Stratford, New Jersey 08084
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-02543/96-001)
Dear Mr. Devine:
This letter refers to the NRC inspection conducted on October 31, November 6, and December 12, 1996, at your facilities in Stratford, New Jersey, of activities authorized by NRC License No. 29-12167-01. During the inspection, apparent violations of NRC requirements were identified. A copy of the NRC inspection report was sent to you on January 17, 1997. On January 29, 1997, a predecisional enforcement conference was conducted with Mr. Brophy and other members of your staff to discuss the apparent violations, their causes, and your corrective actions. A copy of the Enforcement Conference Report is enclosed.
Based on the information developed during the inspection, and information provided during the conference, six violations of NRC requirements are being cited, as described in the enclosed Notice of Violation. The violations involve: (1) failure to maintain dose rates in contiguous unrestricted patient rooms below 2 millirem in any one hour; (2) failure to perform dose estimates for patients in unrestricted patient rooms where the dose rates exceeded 2 millirem in any one hour; (3) reassignment of a therapy patient's room with removable contamination greater than 200 disintegrations per minute per 100 square centimeters; (4) failure to adequately train personnel on the applicable regulations, license conditions, and radiation safety procedures; (5) failure to establish a quorum at the Radiation Safety Committee (RSC) meetings; and (6) failure to decay in storage byproduct material for ten half-lives prior to disposal in ordinary trash.
The NRC recognizes that four of the violations occurred while a former consultant group was contracted to review your program, and that you have taken action to hire a new consultant group. The NRC also recognizes that these four violations were identified during an audit performed by the new consultant group. Nonetheless, the NRC is concerned with management's failure to maintain adequate oversight of the licensed program and to identify these violations earlier.
The NRC license issued to Kennedy Memorial Hospitals - University Medical Center entrusts responsibility for radiation safety to the management of the hospital; therefore, the NRC expects effective oversight of its licensed programs. Incumbent upon each NRC licensee is the responsibility of management in general, and the RSC and Radiation Safety Officer (RSO) in particular, to protect the public health and safety by ensuring that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and expeditiously corrected. Given this lack of management attention towards licensed responsibilities, in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy) 10 CFR Part 2, Appendix C, the violations are classified in the aggregate as a Severity Level III problem, and are set forth in the enclosed Notice.
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) contracting a new consultant group to assist you in providing effective oversight of your licensed program; 2) conducting training on the deficiencies identified during the audit performed by the new consultant group; 3) amending your license to assign a new RSO who has responsibilities in nuclear medicine and can devote more time to performing the RSO duties; 4) circulating the RSC meeting minutes to licensee management; 5) performing a review to determine and understand the applicable regulations and license conditions; 6) providing quarterly training which includes the applicable regulations, license conditions, and radiation safety procedures; and 7) revising the procedure for labeling byproduct material in storage to clearly indicate the earliest acceptable disposal date based on the half-life of the material.
Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, 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.
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 enclosures, and your 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, ORIGINAL SIGNED BY Hubert J. Miller Regional Administrator
Docket No. 030-02543
License No. 29-12167-01
1. Notice of Violation 2. Enforcement Conference Report
State of New Jersey
Kennedy Memorial Hospitals - University Docket No. 030-02543 Medical Center License No. 29-12167-01 Stratford, New Jersey EA 97-006
During an NRC inspection conducted on October 31, November 6, and December 12, 1996, 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 20.1301(a)(2) requires that the licensee conduct operations so that the dose in any unrestricted area from external sources does not exceed 2 millirem in any one hour.
Contrary to the above, on February 20, July 17, and October 30, 1995, and January 29, March 14, and April 15, 1996, the licensee did not conduct its operations so that the dose in any unrestricted area from external sources did not exceed 2 millirem (mrem) in any one hour. Specifically, the dose rates in patient rooms, unrestricted areas contiguous to rooms where iodine-131 therapy patients were hospitalized in accordance with 10 CFR 35.75, exceeded 2 mrem in any one hour. The dose rates measured on these dates were 5 mrem/hr, 6 mrem/hr, 3.5 mrem/hr, 7 mrem/hr, 7 mrem/hr, and 4.5 mrem/hr respectively. (01013)
B. 10 CFR 20.1302(b)(1) requires, in part, that a licensee show compliance with the annual dose limit in 10 CFR 20.1301 by demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation does not exceed the annual dose limit.
Contrary to the above, as of December 10, 1996, the licensee did not show compliance with the annual dose limit in 10 CFR 20.1301 by demonstrating by measurement or calculation that the total effective dose equivalent to the individual likely to receive the highest dose from the licensed operation did not exceed the annual dose limit. Specifically, prior to December 10, 1996, the licensee did not perform dose assessments to verify that patients, in the rooms adjacent to the therapy patients on February 20, July 17, and October 30, 1995, and January 29, March 14, and April 15, 1996, did not receive 100 mrem over the entire therapy. (01023)
C. 10 CFR 35.315(a)(7) requires, in part, that for each patient receiving radio-pharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75, the room must not be reassigned until removable contamination is less than 200 disintegrations per minute per 100 square centimeters.
Contrary to the above, on March 24, 1996, the licensee reassigned the room of a patient who had received radiopharmaceutical therapy and had been hospitalized for compliance with 10 CFR 35.75, with removable contamination in excess of 200 disintegrations per minute per 100 square centimeters (dpm/100 cm2). Specifically, on March 24, 1996, room 481 was released with removable contamination on the floor of approximately 2000 dpm/100 cm2 and 5000 dpm/100 cm2 on a table. (01033)
D. Condition 16 of License Number 29-12167-01 requires, in part, that the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in a license application dated February 25, 1991.
Item 8 of the license application, dated February 25, 1991, requires that the licensee establish and implement the model training program that was published in Appendix A to Regulatory Guide 10.8, Revision 2. Appendix A requires, in part, that instruction for individuals in attendance will include the applicable regulations and license conditions, and the appropriate radiation safety procedures.
Contrary to the above, as of June 1996, the licensee did not provide adequate training on the applicable regulations, license conditions, and radiation safety procedures. Specifically, prior to June 1996, nuclear medicine personnel were not instructed: (1) in the maximum allowable exposure rates in unrestricted patient rooms in accordance with 10 CFR 20.1301(a)(2); (2) to perform dose assessments to verify that patients in these unrestricted patient rooms did not exceed the total effective dose equivalent in accordance with 10 CFR 20.1302(b)(1); and (3) the release criteria for removable contamination in accordance with 10 CFR 35.315(a)(7). (01043)
E. 10 CFR 35.22(a)(3) requires, in part, that to establish a quorum and conduct business, at least one half of the Radiation Safety Committee's membership must be present, including the Radiation Safety Officer.
Contrary to the above, on December 21, 1994, June 28, 1995, and September 26, 1995, the licensee's Radiation Safety Committee met and conducted business and the Radiation Safety Officer was not present to establish a quorum. (01053)
F. 10 CFR 35.92(a) permits a licensee to dispose of byproduct material with a physical half-life of less than 65 days in ordinary trash, provided, in part, that the licensee first holds such byproduct material for decay a minimum of ten half-lives.
Contrary to the above, on September 14, 1995, the licensee disposed of byproduct material with a physical half-life of less than 65 days, in the ordinary trash without first holding the material for decay for a minimum of ten half-lives. Specifically, on September 14, 1995 the licensee disposed of a small quantity of waste (i.e., paper and plastic material) that was previously contaminated with iodine-131 (half-life of 8.04 days) in ordinary trash without first holding this material for decay a minimum of ten half-lives. The byproduct material was placed in storage on July 20, 1995, and therefore, had not decayed 10 half-lives as of September 14, 1995. (01063)
These violations represent a Severity Level III problem (Supplements IV and VI).
Pursuant to the provisions of 10 CFR 2.201, Kennedy Memorial Hospitals - University 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 31st day of January 1997