EA-00-040 - Virginia Commonwealth University, VA

April 24, 2000

EA-00-040

Virginia Commonwealth University
ATTN: Francis L. Macrina, Ph.D.
Acting Vice President
Office of Research
Sanger Hall, Room 1-018
P. O. Box 980568
Richmond, VA 23298-0568

SUBJECT:

NOTICE OF VIOLATION (NRC INSPECTION REPORT NO. 45-00048-17/00-01)

Dear Mr. Macrina:

This refers to the inspection conducted on February 7-9, 2000, at your Richmond, Virginia facility. The purpose of the inspection was to followup on the circumstances regarding an apparent misadministration associated with the loss of a brachytherapy strand containing seven seeds of iridium-192 (Ir-192). Virginia Commonwealth University (VCU) initially reported the event as an apparent misadministration to the Nuclear Regulatory Commission on January 16, 2000. VCU submitted a report of the event to the NRC on February 1, 2000, indicating that it was determined that a misadministration did not occur. The results of the NRC inspection were formally transmitted to you by letter dated March 1, 2000. That letter also provided you the opportunity to either respond to the apparent violations or request a predecisional enforcement conference. By letter dated March 13, 2000, you responded to the apparent violations and addressed the root causes and your corrective actions to prevent recurrence. We have reviewed your event report and the additional information you provided and have concluded that sufficient information is available to determine the appropriate enforcement action in this matter.

In your March 13 response, you provided clarification regarding information documented in our inspection report. We acknowledge that the elapsed time between the discovery that the strand of Ir-192 seeds was missing and when it was retrieved from the laundry facility was three hours and 40 minutes rather than the 18 hours indicated in our inspection report and have corrected our records. Although the source was retrieved in a timely manner, the loss was not reported until the following day, 18 hours from the time it was discovered missing. You attributed the delayed reporting time to your assumption that an apparent misadministration had occurred and that the source was not lost, stolen or missing. The NRC confirmed that a misadministration did not occur, but determined that the event did in fact involve the loss of licensed material. Accordingly, the failure to immediately report a loss of licensed material, under such circumstances, after its loss became known constitutes a violation of 10 CFR 20.2201(a) and is cited as Violation A.(2) of the enclosed Notice. In addition, you contested one aspect of the apparent violation regarding the failure to secure licensed material from unauthorized removal in Rooms 11-036, 11-020, and 3-034 of Sanger Hall (EEI 45-00048-17/00-01-02). The NRC accepts your explanation that, for Room 11-020, a member of the clerical staff confronted VCU radiation safety staff as they attempted to enter the laboratories, and as such, a violation associated with this room did not occur. Accordingly, this cited violation only addresses the failure to secure licensed material in Rooms 11-036 and 3-034 of Sanger Hall.

Based on the information developed during the inspection and the information that was provided in your response, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. Violations A.(1) and A.(2) of the enclosed Notice involve the failure to control and maintain constant surveillance of the 8.68 millicurie (mCi) strand of Ir-192 and the failure to immediately report by telephone to the NRC the loss of licensed materials. The failure to secure and maintain constant surveillance of licensed material constitutes a significant concern in that members of the general public could have been overexposed to radioactive materials. In this case, the Ir-192 source was not only inadequately secured, but the incident was not reported immediately, as required under 10 CFR Part 20. Based on the potential safety significance of the issue, as described in the "General Statement of Policy and Procedures for NRC Enforcement Action" (Enforcement Policy), the violations in Part A have been categorized as a Severity III problem.

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 described in Section VI.B.2 of the Enforcement Policy. Your corrective actions included (1) inservice refresher training provided to all nursing staff from the unit where the incident occurred; (2) posting nursing instructions on patients' doors and in their charts; (3) reminding laboratory personnel of correct waste disposal procedures; and (4) reviewing pertinent sections of Title 10 of the Code of Federal Regulations regarding regulatory reporting requirements for lost, stolen, or missing licensed material. Based on this, the NRC has determined that credit is warranted for the factor of Corrective Action.

To encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement, 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. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has determined that the apparent violation involving the failure to secure from unauthorized removal or limit access to licensed material that was located in two laboratories in Sanger Hall, and the apparent violation involving the failure to label a trash can that contained radioactive waste, should each be characterized at Severity Level IV. These two violations are included in the Notice as Violations B.(1) and B.(2), respectively.

The NRC has concluded that information regarding the reasons for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the dates when full compliance was achieved are addressed on the docket in Inspection Report No. 45-00048-17/00-01, in your February 1, 2000 event report, and in your March 13 response. Therefore, you are not required to respond to this letter unless the description therein does not adequately 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.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosure, and your response, if any, will be placed in the NRC Public Document Room.

		Sincerely,
		/RA/
		Luis A. Reyes Regional Administrator

Docket No. 030-03297
License No. 45-00048-17

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Virginia
Virginia Commonwealth University
Attn: Mr. Edward L. Flippen
Rector, Board of Visitors
Office of President
Box 842512
Richmond, Virginia 23284

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NOTICE OF VIOLATION
Virginia Commonwealth University Richmond, Virginia		Docket No. 030-03297 License No. 45-00048-17 EA-00-040

During an NRC special inspection conducted on February 7-9, 2000, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A.	(1)	10 CFR 20.1801 requires that licensees secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 further requires that licensees control and maintain constant surveillance of licensed material that is in controlled or unrestricted areas and that is not in storage. 10 CFR 20.1003, defines the term "controlled area" as used in this part as an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason. 10 CFR 20.1003, defines the term "restricted area" as used in this part as an area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. 10 CFR 20.1003, defines the term "unrestricted area" as used in this part as an area, access to which is neither limited nor controlled by the license. Contrary to the above, on January 14, 2000, the licensee lost control of licensed material. Specifically, a brachytherapy strand containing seven seeds of iridium-192 (Ir-192) with a total activity of 8.68 millicuries (mCi) was removed from a patient's room in bed linen, and transferred to an offsite laundry facility. (01031)
	(2)	10 CFR 20.2201(a) requires, in part, that each licensee immediately report by telephone immediately after its occurrence becomes known to the licensee, any lost, stolen, or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix C to Part 20 under such circumstances that it appears to the licensee that an exposure could result to persons in unrestricted areas. Contrary to the above, on January 14, 2000, the licensee failed to report by telephone to the NRC immediately after its occurrence became known that lost or missing licensed material in an aggregate quantity equal to or greater than 1,000 times the quantity specified in Appendix C to Part 20 under such circumstances that it appeared to the licensee that an exposure could result to persons in unrestricted areas. Specifically, the loss of an 8.68 mCi of Ir-192 source was reported 18 hours after its loss became known. (01032)
This is a Severity Level III problem (Supplement IV).
B.	(1)	10 CFR 20.1801 requires that licensees secure from unauthorized removal or access licensed materials that are stored in controlled or unrestricted areas. 10 CFR 20.1802 further requires that licensees control and maintain constant surveillance of licensed material that is in controlled or unrestricted areas and that is not in storage. 10 CFR 20.1003, defines the term "controlled area" as used in this part as an area, outside of a restricted area but inside the site boundary, access to which can be limited by the licensee for any reason. 10 CFR 20.1003, defines the term "restricted area" as used in this part as an area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to radiation and radioactive materials. 10 CFR 20.1003, defines the term "unrestricted area" as used in this part as an area, access to which is neither limited nor controlled by the license. Contrary to the above, on February 8, 2000, the licensee did not secure from unauthorized removal or limit access to 0.910 mCi of phosphorus-32 (P-32) and 0.095 mCi of sulfur-35 (S-35) in Room No. 11-036 of Sanger Hall, and 3.000 mCi of P-32, 1.750 mCi of S-35, and 10.400 mCi of hydrogen-3 in Room No. 3-034 of Sanger Hall, unrestricted areas, and the licensee did not control and maintain constant surveillance of this licensed material.
This is a Severity Level IV violation (Supplement VI).
	(2)	10 CFR 20.1904(a) requires the licensee to ensure that each container of licensed material bears a durable, clearly visible label bearing the words "CAUTION, RADIOACTIVE MATERIAL," or "DANGER, RADIOACTIVE MATERIAL." The label must also provide sufficient information (such as the radionuclide(s) present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, etc.) to permit individuals handling or using the containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures. Contrary to the above, on February 8, 2000, a non-radioactive trash container did not bear a label that identified the radionuclide or the quantity of radioactivity, nor did it otherwise bear sufficient information to permit individuals handling or using the container, or working in the vicinity of the container, to take precautions to avoid or minimize exposure. Specifically, the trash can located in Room No. 3-038 of Sanger Hall contained paper towels contaminated with P-32 with dose measurements of two millirem per hour at contact.
This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and date when full compliance was achieved is already adequately addressed on the docket in Inspection Report No. 45-00048-17/00-01, and your February 1, 2000, and March 13, 2000, letters. 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 chose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region II, 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 20555-0001.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, any response shall be submitted under oath or affirmation.

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, proprietary, or safeguards information so that it can be place in the PDR without redaction.

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

Dated this 24th day of April 2000
Atlanta, Georgia