EA-97-426 - Temple University
February 20, 1998
Leon Malmud, M.D.
Vice President, Health Sciences Center
3401 North Broad Street
Philadelphia, Pennsylvania 19140
|SUBJECT:||NOTICE OF VIOLATION
(NRC Inspection Report Nos. 030-02963/97-001 and 030-00458/97-01 & NRC
Office of Investigation Report Synopsis No. 1-97-001)
Dear Dr. Malmud:
This letter refers to the NRC inspection conducted on September 16-24, October 6, and November 16 and 21, 1997, at your facilities in Philadelphia, Pennsylvania to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. This also refers to the investigation conducted by the NRC Office of Investigation to determine whether a Nuclear Medicine Technologist (NMT) at your facility falsified a September 28, 1996 record of a weekly wipe survey of the nuclear medicine hot lab for removable contamination. During the inspection and investigation, seven apparent violations of NRC requirements were identified. The violations were discussed with several members of your staff at the conclusion of the inspection, and were described in the subject Inspection Report and OI synopsis sent to you with our letter, dated January 13, 1998. On January 22, 1998, a Predecisional Enforcement Conference was conducted with you and other members of your staff to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report was forwarded to you by separate correspondence on February 19, 1998.
Based on the information developed during the inspection and the information provided during the conference, six violations of NRC requirements are being cited and 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 two violations are described in Section I of the enclosed Notice, and involve (1) the failure to conduct a weekly wipe survey of the Nuclear Medicine Lab in September 1996, and (2) the deliberate creation of an inaccurate NRC-required record by entering survey data on the survey sheet even though the survey was not done. These two violations were identified during your internal investigation. Based on the investigation by the NRC Office of Investigations, the NRC staff concludes that a Nuclear Medicine Technologist deliberately falsified the record. At the enforcement conference, you indicated that your investigation of this issue did not conclude that the record was deliberately falsified. However, the NRC staff maintains that the individual, who refused to be interviewed by OI, and who provided conflicting testimony during your investigation, did not do the weekly survey, and clearly knew, when he created the record, that he did not do the survey. Therefore, given the deliberate creation of the inaccurate record, the violations are 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.
Three other violations are described in Section II of the enclosed Notice, and involve: (1) the release of patients treated with temporary implants of cesium-137 and iridium-192, as well as patients treated with the High Dose Rate Afterloader, without performing a radiation survey of the patients to confirm that all sources had been removed; (2) the failure to return cesium-137 brachytherapy sources to the storage area and count the number returned, after such sources were used; and (3) the failure to determine the accuracy of source positioning for the HDR source on a monthly basis in 1996. These three violations collectively represent a significant lack of attention toward licensed responsibilities and therefore are also classified in the aggregate as a Severity Level III problem in accordance with the Enforcement Policy.
As you know, the enforcement conference conducted with you on January 22, 1998 to discuss these violations was the fourth enforcement conference conducted with you since October 1995. The violations discussed in the prior conferences resulted in the NRC issuance of two prior civil penalties in the amount of $8,000 on December 15, 1995, and $10,000 on December 31, 1996, for violations involving discrimination against a former employee who raised safety concerns, a willful failure to perform spot checks of the HDR on a monthly basis, and violation of security requirements. The violations cited in the enclosed Notice would appear to indicate the continuation of a declining trend in the performance of Temple University with respect to its NRC license and Temple management's ability to ensure adherence to NRC requirements. However, the NRC recognizes that all of the violations in Sections I and II of the Notice occurred prior to 1997 and were identified by your staff. The NRC also recognizes that at the root of many of the violations was (1) the fact that there was not a full-time RSO at Temple for many years; (2) the radiation safety staff was untrained and ineffective; (3) the professional staff was poorly trained; and (4) there was a lack of attention to detail in recordkeeping by many Temple staff members. The NRC further recognizes that there has been improvement in the oversight of the radiation safety program since the assignment of a full-time RSO in April 1997. The NRC expects that these improvements will continue in order to ensure that licensed activities are conducted safely and in accordance with NRC requirements.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation or problem. With respect to both of the Severity Level III problems, because your facility has been the subject of escalated enforcement actions within the last two years, as already indicated herein, 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 warranted in each case because you did identify the violations. Credit for corrective actions is also warranted since the actions were considered prompt and comprehensive. These actions included (1) assigning a new environmental health and safety officer whose sole responsibility is to maintain oversight of the radiation safety program through the RSO and staff; (2) reorganization of the Radiation Safety Committee by June 2, 1997; (3) revision to procedures and forms for implementing the program; (4) increased training of personnel; (5) increased overall oversight of the program by management; and (6) your investigation and remedial actions regarding the inaccurate record.
Therefore, to emphasize the importance of prompt identification and correction of problems at the facility, I have been authorized, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. However, any similar violations in the future could result in more significant action.
The NRC is continuing to evaluate the NMT's deliberate misconduct and whether enforcement action should be taken against him. The NRC has corresponded with the NMT. You will receive a copy of this correspondence under separate cover.
You are required to respond to this Notice 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 any response will be placed in the NRC Public Document Room (PDR).
Hubert J. Miller
Docket Nos. 030-02963; 030-00458
License Nos. 37-00697-31; 37-00697-02
Enclosure: Notice of Violation
Commonwealth of Pennsylvania
NOTICE OF VIOLATION
|Docket Nos. 030-02963; 030-00458
License Nos. 37-00696-31; 37-00697-02
During an NRC inspection conducted on September 16-24, October 6, and November 16 and 21, 1997, as well as an investigation by the NRC Office of Investigations, 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 particular violations and associated civil penalties are set forth below:
I. VIOLATIONS ASSOCIATED WITH FAILURE TO PERFORM CONTAMINATION SURVEY AND CREATION OF INACCURATE RECORD
A. 10 CFR 35.70(e) requires that a licensee survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
Contrary to the above, during the week of September 22 through 28, 1996, the licensee did not do a weekly survey for removable contamination in the Nuclear Medicine Hot Lab, an area where radiopharmaceuticals were routinely prepared and stored. (01013)
B. 10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee, or information required by the Commission's regulations to be maintained by the licensee, shall be complete and accurate in all material respects.
Contrary to the above, information that the licensee was required to maintain in accordance with 10 CFR 35.70(h), was not accurate in all material respects. Specifically, on September 28, 1996, a record was created of a weekly wipe survey performed in the Nuclear Medicine Hot Lab, and the record was inaccurate in that it indicated that the weekly wipe survey was performed, when in fact the survey was not performed. This record was material because it had the capability to influence an NRC assessment as to whether the survey had been performed to comply with 10 CFR 35.70(e). (01023)
These violations represent a Severity Level III problem (Supplements VI and VII).
II. VIOLATIONS ASSOCIATED WITH BRACHYTHERAPY PROGRAM
A. 10 CFR 35.404(a) requires that, immediately after removing the last temporary implant source from a patient, the licensee make a radiation survey of the patient with a radiation detection survey instrument to confirm that all sources have been removed, and that the licensee not release from confinement for medical care a patient treated by temporary implant until all sources have been removed.
Contrary to the above, on February 22, 1996, and November 11 and 16, 1995, the licensee released patients treated with temporary implant sources (either brachytherapy sources containing cesium-137), or and on September 20, 1995, October 18, 1995, October 20, 1995, and April 11, 1996, the licensee released patients treated with HDR sources (containing iridium-192), and the licensee did not perform adequate radiation surveys of the patient to confirm that all sources had been removed. (02013)
B. 10 CFR 35.406(a) requires that promptly after removing them from a patient, a licensee return brachytherapy sources to the storage area and count the number returned to ensure that all sources taken from the storage area have been returned.
Contrary to the above, after removing cesium-137 brachytherapy sources from a patient on August 30, 1996, the licensee did not count the number returned to the storage area until September 3, 1996. (02013)
C. Condition No. 32 of License No. 37-00697-31 states, in part, that the licensee shall conduct its program in accordance with statements, representations and procedures contained in a letter dated March 8, 1994.
Item VIII.B.2(a-d) of the letter dated March 8, 1994, states that the accuracy of the source positioning for the HDR source will be determined monthly.
Contrary to the above, the licensee did not correctly determine the accuracy of source positioning for the HDR source during 1996. Specifically, the radiographs produced when this test was performed indicate that the HDR source was not indexed relative to the end of the catheter; therefore, the actual accuracy in positioning the source was not ascertained. (02023)
These violations represent a Severity Level III problem (Supplement VI).
III. OTHER VIOLATION OF NRC REQUIREMENTS
10 CFR 35.615(d)(2) requires that the licensee's permanent radiation monitor to the teletherapy unit have an operable backup power supply separate from the power supply to the teletherapy unit.
Contrary to the above, on September 16, 1997, the licensee's permanent radiation monitor did not have an operable backup power supply separate from the power supply to the teletherapy unit. Specifically, on that date, the backup power supply to the teletherapy room's permanent radiation monitor was found to be inoperable. (03014)
This is a Severity Level IV violation. (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Temple University (Licensee) 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.
If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, D.C. 20555-0001.
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. 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 20th day of February 1998