EA-98-276 - ViroMed Laboratories, Inc.

May 27, 1998

EA 98-276

Bonita Baskin, Ph.D.
President
ViroMed Laboratories, Inc.
6101 Blue Circle Drive
Minneapolis, MN 55343

SUBJECT:

NOTICE OF VIOLATION AND NRC INSPECTION REPORT 030-32617/98001(DNMS)

Dear Dr. Baskin:

This refers to the inspection conducted on April 30, 1998, with continuing NRC review through May 6, 1998, at ViroMed Laboratories, Inc. in Minneapolis, Minnesota. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. During the inspection several apparent violations of NRC requirements were identified and considered for escalated enforcement. The apparent violations and areas examined during the inspection are described in the enclosed report.

Based on the information developed during the inspection and the information provided in your letter dated May 12, 1998, 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. The violations include failures to: (1) perform required radiation surveys when handling iodine-125; (2) obtain the appropriate approvals prior to ordering licensed material; (3) make the appropriate notifications upon receipt of radioactive material; (4) follow package receipt and survey procedures; (5) monitor empty package material prior to discard; (6) perform monthly laboratory surveys; and (7) monitor the radioactive storage room on a monthly basis.

Collectively, the violations demonstrate a programmatic breakdown in the control over licensed activities. The root cause of this breakdown stems from the lack of program oversight by the Radiation Safety Officer and ViroMed management. Individually, the safety significance of the violations is low because of the small quantity of radioactive materials currently being used. However, collectively, the violations are of significant regulatory concern to the NRC because they cover the breath of your program. Incumbent upon each NRC licensee is the responsibility to ensure that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and corrected expeditiously. Therefore, these violations are classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level 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 in Section VI.B.2 of the Enforcement Policy. Based upon the corrective actions taken following the inspection and those actions identified in your letter dated May 12, 1998, credit for Corrective Action was warranted. In addition to addressing each of the individual violations, the corrective actions planned or taken to address the root causes include: (1) providing training on your license commitments and pertinent NRC regulations for all individuals who work with licensed material; (2) upgrading of the radioactive material procurement methods as well as the inventory process to provide for better oversight by the RSO; (3) reviewing all of the program commitments to ensure compliance with NRC requirements by the RSO and his designee; (4) scheduling the RSO to receive specialized radiation safety training in June 1998; and (5) developing an audit program to be implemented by the Quality Assurance Department.

Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action, I have been authorized after consultation with the Director, Office of Enforcement, 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 the Severity Level III problem constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC has concluded that the reasons for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence are already adequately addressed in your letter dated May 12, 1998. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

The NRC has concluded that we have sufficient information to make an informed enforcement decision without the need for a predecisional enforcement conference. However, in accordance with the NRC Enforcement Policy, NUREG 1600, Rev. 1, you may request an enforcement conference to discuss the violations and/or any disputes regarding them. If this is your choice, please contact Geoffrey Wright at (630) 829-9602 within seven days of the date of this letter.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, the enclosed Notice, and your response, if you choose to respond, will be placed in the NRC Public Document Room.

Sincerely, Original Signed By John Grobe for Carl J. Paperiello Acting Regional Administrator

Docket No. 030-32617
License No. 22-26376-01

Enclosures:

1. Notice of Violation 2. Inspection Report 030-32617/98001 (DNMS)

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NOTICE OF VIOLATION
ViroMed Laboratories, Inc. Minneapolis, Minnesota		EA 98-276 Docket No. 030-32617 License No. 22-26376-01

During an NRC inspection conducted on April 30, 1998, with continuing NRC review through May 6, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

Condition 16 of License No. 22-26376-01 requires, in part, that the licensee shall conduct its program in accordance with statements, representations and procedures contained in a letter dated March 13, 1995, and the attached Radiation Safety Manual (RSM).

A.	Section II.D of the referenced RSM titled, Work Area Radioactivity Level Surveys, requires, in part, that the laboratory in which iodine-125 work is performed will be surveyed before, during, and after use with the Ludlum survey meter equipped with LSD probe.
	Contrary to the above, between February 1998 and April 30, 1998, iodine-125 work was performed on several occasions and laboratory surveys were not performed during use as required.
B.	Section III.A of the referenced RSM titled, Procedures for Ordering Materials Containing Radioactivity, requires, in part, that the: (1) user must submit the Purchase Requisition form to the Radiation Safety Officer (RSO) or designee; (2) RSO or designee must review the order and determine if it complies with ViroMed's NRC license; and (3) RSO or designee will approve orders by signing the Purchase Requisition form.
	Contrary to the above, on numerous occasions between January 15, 1998 and April 30, 1998 radioactive material was ordered, but: (1) users did not submit Purchase Requisition forms to the RSO or designee; (2) the RSO or designee did not review the orders to ensure compliance with ViroMed's NRC license; and (3) the RSO or designee did not approve orders by signing the Purchase Requisition form.
C.	Section III.B.2 of the referenced RSM titled, Procedure for Receipt of Radioactive Material, requires, in part, receiving personnel to notify the RSO that a radioactive shipment has arrived.
	Contrary to the above, between January 15, 1998 and April 30, 1998, receiving personnel did not notify the RSO when radioactive shipments arrived.
D.	Section III.B.3 of the referenced RSM titled, Procedure for Receipt of Radioactive Material, requires, in part, the RSO or designee to conduct a swab test of the external surface of a package as well as an exposure rate at the package surface and at one meter from the package surface with a Geiger Mueller.
	Contrary to the above, on numerous occasions between January 15, 1998 and April 30, 1998, the RSO did not conduct surveys to determine exposure rates at the package surface and at one meter from the packages with a Geiger Mueller as required.
E.	Section III.C of the referenced RSM titled, Procedure For Safely Opening Packages Containing Radioactive Material, requires, in part, packing material and empty packages to be monitored for contamination with a radiation detection survey meter before discarding.
	Contrary to the above, since at least January 1993 until April 30, 1998, packaging materials and empty packages were not monitored for contamination before discarding.
F.	Section III.D.3. of the referenced RSM titled, Procedures Before, During and After Use of Radioactive Materials, requires, in part, monthly swab tests to be performed in designated areas where iodine-125 (isolation laboratory) and carbon-14 are used (AFB laboratory).
	Contrary to the above, as of April 30, 1998, monthly swab tests of the designated areas where microcurie quantities of iodine-125 were used had not been performed since at least February 1998, and monthly swab tests in designated areas where microcurie quantities of carbon-14 were used had not been performed since at least 1992.
G.	Section IV.B of the referenced RSM titled, Radioactive Waste Management — ViroMed Procedure, requires, in part, that monitoring of the radioactive storage room will be performed on a monthly basis by both a filter swab test and by GM.
	Contrary to the above, since December 17, 1997, the radioactive storage room had not been monitored by either method

These violations represent a Severity Level III problem (Supplement VI).

The NRC has concluded that information regarding the reasons for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed in a letter from ViroMed Laboratories, Inc. dated May 12, 1998. However, you are required to respond to the provisions of 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose 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 III, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.

If you contest this enforcement action, you should also provide a copy of your response, with the basis for denial, to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of 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, it should not include any personal, privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Dated at Lisle, Illinois