EA-96-455 - Temple University
Leon Malmud, M.D.
Vice President, Health Sciences Center
3401 North Broad Street
Philadelphia, Pennsylvania 19140
SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES - $10,000 (NRC Inspection Report Nos. 030-02963/96-002 and 030-00458/96-002)
Dear Dr. Malmud:
This refers to the NRC inspection conducted on September 30 and October 1, 2, 24, and 25, 1996, at your facilities in Philadelphia, Pennsylvania to determine whether activities authorized by your licenses were conducted safely and in accordance with NRC requirements. During the inspection, six 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 sent to you with our letter, dated November 21, 1996. On December 6, 1996, 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 will be forwarded to you by separate correspondence.
Based on the information developed during the inspection and the information provided during the conference, the NRC has determined that six violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice), and the circumstances surrounding them are described in detail in the subject inspection report.
The first violation is described in Section I of the enclosed Notice and involves two examples of failure to secure licensed radioactive material at the facility. With respect to the first example, the Nuclear Medicine Hot Lab, an unrestricted area in which a 2 curie molybdenum-99/technetium-99m generator and other licensed radioactive materials were located, was not controlled nor under the constant surveillance of your staff. The inspectors found that one of the three doors providing access to the Nuclear Medicine Department Hot Lab, which opens into a corridor located within the Department, was unlocked. At the enforcement conference, you concluded that your housekeeping staff had a key to this door and was using the space for storage of cleaning supplies, even though you did not authorize housekeeping to have access to the Hot Lab. With respect to the second example of the failure to control access to material at the facility, millicurie quantities of hydrogen-3, sulfur-35, and iodine-125 were observed by the inspectors in unlocked refrigerators located in unlocked laboratories, without that material being controlled or under the constant surveillance of your staff. These two violations of the security requirements represent a significant safety and regulatory concern because the failure to adhere to these security requirements could result in the loss or theft or radioactive material, as well as the unnecessary radiation exposure to staff and the public. Therefore, this violation is classified at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
The second violation is described in Section II of the enclosed Notice and involves the willful failure by a contractor Medical Physicist to perform spot checks of the high dose-rate remote afterloader on a monthly basis as required. The contractor Medical Physicist, in response to questioning by the NRC staff during the December 6, 1996 enforcement conference, indicated that he knew that the HDR unit had not been calibrated during certain months because of scheduling problems, yet he continued to allow patients to be treated. This violation in Section II of the Notice also represents a significant regulatory concern because of its willful nature and also has been classified at Severity Level III in accordance with the Enforcement Policy.
The other four violations are described in Section III of the enclosed Notice and involve: (1) the failure to perform a full calibration of the teletherapy unit between June 1994 and August 1995, as required; (2) the failure to ensure that licensed materials were used only by, or under the supervision of, individuals who are designated by the Temple University Radiation Protection Committee (TURPC) (specifically, in two cases, researchers requested and received material based on approval by the Research Subcommittee prior to approval by the TURPC); (3) failure to document the level of removable contamination found on packages in the required units; and (4) failure to test each dose calibrator for linearity at least quarterly.
While these violations have been classified individually at Severity Level IV and are not the subject of escalated enforcement action, the NRC is concerned because of the repetitive nature of Violations III.A and B. These two violations were identified during prior inspections at the facility in 1994 and 1995.
These recent violations indicate a disturbing and declining trend in the performance of Temple University with respect to its NRC licenses. The licenses issued to Temple University place a significant responsibility on the management of the University to ensure that activities are conducted safely and in accordance with the terms of the licenses. Notwithstanding that high responsibility, Temple management has not ensured adherence to NRC requirements, as evidenced by the fact that the enforcement conference conducted with Temple on December 6, 1996 was the third enforcement conference conducted with you since October 1995. In addition, an $8,000 civil penalty was issued to Temple on December 15, 1995 for a violation involving the discrimination against a former employee who raised safety concerns.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. With respect to both Severity Level III violations, 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 not warranted in either case because you did not identify the violations. The NRC acknowledges the corrective actions you have taken or planned that consist of: (1) plans to hire a permanent Radiation Safety Officer (RSO) and requiring that the new RSO perform a full review of the licensed program during the first quarter of 1997; (2) reviewing existing management structures; (3) changing locks in the nuclear medicine Hot Lab; (4) development of matrices to ensure that staff are aware of calibration schedules for instruments and devices; and (5) increasing RSO oversight of the clinical areas. These corrective actions notwithstanding, the NRC has determined that credit is not warranted based on Corrective Action for either Violation I or II. Regarding Violation I, credit for corrective action is not warranted because, although you took immediate action to correct the specific security deficiencies identified by NRC, your actions to date have been narrowly focused, have not addressed the broader problem of detecting and deterring security violations, and for the most part, have not been implemented despite the problems being called to your staff's attention during the exit meeting on October 25, 1996. For example, at the time of the predecisional enforcement conference, many of the actions were still in the planning stages, such as plans to retrain all personnel on security requirements; review security for all laboratories; issue a directive to all staff requiring that licensed material be secured by locking; and increase the frequency of laboratory audits. Regarding Violation II, credit for corrective action is not warranted because the Medical Physicist admitted that he knew that the HDR unit had not been calibrated during certain months, yet he continued to allow patients to be treated. Credit for corrective action is not warranted if immediate corrective action is not taken to restore safety and compliance once a violation is known.
Therefore, to emphasize the unacceptability of willful violations and the importance of appropriate management attention to ensure adherence to NRC requirements, including requirements to maintain appropriate security and control of licensed material at the facility, I have been authorized, after consultation with the Director, Office of Enforcement, to propose a cumulative civil penalty in the amount of $10,000 for the violations listed in Sections I and II of the Notice.
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).
Sincerely, Hubert J. Miller Regional Administrator
Docket Nos. 030-02963, 030-00458
License Nos. 37-00697-31, 37-00697-02
Enclosure: Notice of Violation and Proposed
Imposition of Civil Penalties
Commonwealth of Pennsylvania
Temple University Docket Nos. 030-02963, 030-00458 Philadelphia, Pennsylvania License Nos. 37-00696-31, 37-00697-02 EA 96-455
During an NRC inspection conducted on September 30 and October 1, 2, 24, and 25, 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 NRC proposes to impose civil penalties 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 particular violations and associated civil penalties are set forth below:
I. Violation Involving Security of Licensed Material
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.
Contrary to the above, the licensee failed to secure from unauthorized removal or limit access to licensed material stored in controlled or unrestricted areas, as evidenced by the following two examples:A. on October 1, 1996, the licensee did not secure from unauthorized removal or limit access to a 2 curie molybdenum 99-technetium 99m generator located in the Nuclear Medicine Department Hot Lab (an unrestricted area at the time since it was neither locked nor attended), nor did the licensee control and maintain constant surveillance of this licensed material. This was evidenced by the fact that an NRC inspector found the Hot Lab door unlocked and accessed by housekeeping staff, persons not authorized to have access to the area.
B. on September 30 and October 24, 1996, the licensee did not secure from unauthorized removal or limit access to a total of six millicuries of hydrogen-3, 1 millicurie of iodine-125, and 1 millicurie of sulfur-35 located in unlocked refrigerators in unlocked laboratories (located in the Kresge, Old Medical School, and Medical Research buildings), nor did the licensee control and maintain constant surveillance of this licensed material.
This is a Severity Level III violation (Supplement IV).
Civil Penalty - $5,000
II. Violation Involving Failure to Perform HDR Spot Checks
10 CFR 35.21(a) requires that the licensee, through the Radiation Safety Officer, ensure that radiation safety activities are being performed in accordance with approved procedures.
The licensee's procedures for performing spot checks of the high dose rate remote afterloader calibration are described in the letter dated March 8, 1994, and were approved by License Condition No. 32.
The letter dated March 8, 1994, states in Item No. VIII.C.5, that the calibration of the high dose rate remote afterloader will be performed following installation of a new source, before treatment is resumed, and monthly thereafter.
Contrary to the above, as of October 25, 1996, the licensee, through its Radiation Safety Officer, did not ensure that radiation safety activities were being performed in accordance with the above procedures. Specifically, calibration of the high dose rate remote afterloader was not performed monthly since calibrations were not performed between April 25 and July 1, 1995; between September 9 and November 6, 1995; and between March 15 and May 10, 1996.
This is a Severity Level III violation (Supplement VI).
Civil Penalty - $5,000
III. Violations of Other NRC Requirements
A. 10 CFR 35.21(a) requires that the licensee, through the Radiation Safety Officer, ensure that radiation safety activities are being performed in accordance with approved procedures.
The licensee's procedures for approving users of licensed materials are described in the letter dated March 20, 1993, and were approved by License Condition No. 32.
The letter dated March 20, 1993, specifies in Policy 4.4, that a person shall not manufacture, produce, acquire, receive, possess, use, or transfer radioactive material under the license except in accordance with a specific authorization approved by the Temple University Radiation Protection Committee (TURPC).
Contrary to the above, as of October 25, 1996, the licensee, through its Radiation Safety Officer, did not ensure that radiation safety activities were performed in accordance with the above procedures. Specifically, researchers were permitted to possess and use radioactive material under the license prior to specific authorization by the TURPC if they have been approved by the TURPC's Research Subcommittee.
This is a repeat violation.
This is a Severity Level IV violation (Supplement VI).
B. 10 CFR 35.632(a)(3) requires that full calibration measurements on each teletherapy unit be conducted at intervals not to exceed one year.
Contrary to the above, the licensee did not perform a full calibration of its teletherapy unit from June 1994 to August 1995, a period in excess of one year.
This is a repeat violation.
This is a Severity Level IV violation (Supplement VI).
C. 10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity at least quarterly.
Contrary to the above, the licensee did not test its dose calibrator for linearity from
- March 29, 1995 until July 17, 1995, a period in excess of a calendar quarter; and
- March 11, 1996 until July 1, 1996, a period in excess of a calendar quarter.
This is a Severity Level IV violation (Supplement VI).
D. 10 CFR 20.1906(b)(1) requires that the licensee monitor the external surfaces of each labeled package for radioactive contamination by smearing the surface of the labeled package. 10 CFR 20.2103(a) requires that each licensee maintain the records showing the results of surveys required by 10 CFR 20.1906(b). 10 CFR 20.2101(a) requires that each licensee use the units: curie, rad, rem, including multiples and subdivisions, and clearly indicate the units of all quantities required by Part 20.
Contrary to the above, as of October 25, 1996, the licensee did not use the units: curie, rad, rem, including multiples and subdivisions, and clearly indicate the units of all quantities required by Part 20. Specifically, the licensee performed the surveys required by 10 CFR 20.1906(b)(1) but the records of these surveys, required by 10 CFR 20.2103(a), were not expressed as curies or, its subdivision, disintegrations per minute.
This is a Severity Level IV violation (Supplement IV).
Pursuant to the provisions of 10 CFR 2.201, Temple University (Licensee) is hereby 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 Penalties (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 penalties 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 penalties 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 penalties will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, 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(s) 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 penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.
In requesting mitigation of the proposed penalties, 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 penalties, 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 penalties, 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, or proprietary 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).
Dated at King of Prussia, Pennsylvania
this 31st day of December 1996