EA-97-069 - Massachusetts Medical Center
Edward Bresnick, Ph.D.
Vice Chancellor for Research
University of Massachusetts
55 Lake Avenue North
Worcester, Massachusetts 01655
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-01972/97-001)
Dear Dr. Bresnick:
This refers to the NRC inspection conducted on February 4-6, 1997 at your facilities in Worcester, Massachusetts. The purpose of the inspection was to determine whether activities authorized by the your NRC broad-scope license were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with you and the members of your staff identified in the inspection report. During the inspection, two apparent violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter, dated February 19, 1997. As a result of the inspection, a Confirmatory Action Letter was issued to you on February 12, 1997, which confirmed certain of your commitments to enhance the security at the facility. In addition, a predecisional enforcement conference was held with you and members of your staff on February 27, 1997, to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be sent by separate correspondence.
Based on the information developed during the inspection and the information you provided during the conference, the NRC has determined that two violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The first violation involves several examples of failure to secure licensed radioactive material or limit access to the material at your facilities. In one case, your Radiation Safety Officer (RSO) found, on the day prior to the inspection, that your staff did not secure from unauthorized removal, or limit access to, a strontium-90 generator (containing between 100-200 millicuries) located in Room 806 of your Medical Center, and did not limit access to Room 802 that had strontium-90 contamination in a sink, two byproduct waste barrels, and contaminated apparatus used with the strontium-90 generator eluent. This example, although identified by the RSO, is particularly significant given the nature and amount of the material involved, and also because the principal investigator (PI) for Room 802 also was the Radiation Safety Committee (RSC) chairman. In addition, during the inspection, the NRC inspector identified additional examples of laboratories containing microcurie quantities of phosphorus-32, and hydrogen-3 that was not controlled or maintained under constant surveillance. In one case, the finding was particularly egregious in that the inspector had informed a researcher that a laboratory was unsecured and unattended, yet, when the inspector returned approximately 20 minutes later, the inspector again found the researcher had again left the area unsecured and unattended.
This violation represents a significant regulatory concern because the failure to maintain appropriate security of material could result in the material being lost or stolen, and also has the potential to cause unnecessary exposures to members of your staff as well as members of the public. While the NRC commends your radiation safety office staff who identified several other indications of unsecured material over the past several months, the NRC is concerned that prior to the inspection, effective actions had not been taken to preclude recurrence of these findings. The number and nature of these findings represents a significant failure to control licensed material and therefore, the 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.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. 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 enforcement conference, were considered prompt and comprehensive. These actions, which were described at the enforcement conference, or in conversations with Dr. Shanbaky of my staff prior to the Confirmatory Action Letter, included, but were not limited to: (1) replacement of the RSC Chairman; (2) plans to have the RSO or designees tour, every two weeks, all areas where radioactive material is stored or used, including tours on weekends, holidays, and other than normal working hours; (3) issuance of a memorandum to all Permit Holders notifying them of the NRC findings, reminding them of the need to maintain adequate security, and requiring them to attend a meeting to discuss security; (4) requiring a permit holders to submit a security plan for their laboratories; and (5) plans to conduct an onsite evaluation of each permit holder's security plan.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized not to propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.
In addition to the security violation, one other violation was identified as described in the enclosed Notice. That additional violation is classified at Severity Level IV. Also, one of the apparent examples of the security violation described in the inspection report is being withdrawn , based on information you provided during the enforcement conference that the material in S6-746 was determined, after the inspection, to be exempt quantities.
You are required to respond to this letter 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 your response will be placed in the NRC Public Document Room (PDR).
Sincerely, ORIGINAL SIGNED BY CHARLES W. HEHL FOR Hubert J. Miller Regional Administrator
Docket No. 030-01972
License No. 20-13758-01
Enclosure: Notice of Violation
Commonwealth of Massachusetts
University of Massachusetts Docket No. 030-01972 Worcester, Massachusetts License No. 20-13758-01 EA 97-069
During an NRC inspection conducted on February 4-6, 1997, 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 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, an unrestricted area means an area, access to which is neither limited nor controlled by the licensee.
Contrary to the above,
- on February 3, 1997, the licensee did not secure from unauthorized removal or limit access to licensed material stored in Rooms 806 and 802 of the Medical Center, unrestricted areas, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically, on that date, the licensee's Radiation Safety Officer identified that the two labs were left open and unsecured, and at the time, Room 806 contained a 100-200 millicurie strontium-90 generator, and Room 802 had strontium-90 contamination in a sink, two byproduct waste barrels, and contaminated apparatus used with the strontium-90 generator eluent; and
- between February 4-6, 1997, the licensee did not secure from unauthorized removal or limit access to licensed material stored in certain laboratories, unrestricted areas, nor did the licensee control and maintain constant surveillance of this licensed material. Specifically,a. labeled vials containing approximately 356 microcuries of phosphorus-32 were found in a posted refrigerator within posted laboratory (Room S7-129); however, the refrigerator and the laboratory were unlocked and the laboratory was unattended;
b. a labeled vial containing approximately 250 microcuries of phosphorus-32 (as of January 18, 1997), was found in a posted refrigerator within a posted laboratory (Room S4-221); however, the refrigerator and laboratory were unlocked and the laboratory was unattended;
c. vials containing approximately 1130 microcuries of phosphorus-32 (as of February 2, 1997), 300 microcuries of phosphorus-32 (as of December 30, 1996), and 46 microcuries of hydrogen-3, were found in a posted refrigerator within a posted laboratory Suite 301 of the 373 Plantation Street facility; however, the refrigerator and laboratory were unlocked and the laboratory was unattended. The vials were contained inside a small locked plexiglass container measuring approximately 4"x8"x12"; however, this container was easily removable and not secured.
This is a Severity Level III violation (Supplements IV and VI).
B. 10 CFR 35.406(b) requires, in part, that a licensee make a record of brachytherapy source use, including the number and activity of sources removed from storage.
Contrary to the above, on February 5, 1997, the licensee's record of brachytherapy source usage for December 18-20, 1996, did not include the number and activity of sources removed from storage.
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, University of Massachusetts is 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 the Notice, an order or 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, 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 28th day of February 1997