EA-96-157 - Universal Imaging, Inc.

August 2, 1996

EA 96-157

Mr. Phil Young
Chief Executive Officer
Universal Imaging, Inc.
12450 Universal Drive
Taylor, MI 48180

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-33326/96001(DNMS))

Dear Mr. Young:

This refers to the inspection conducted from April 29 to June 10, 1996, to review a misadministration of NRC-licensed material (iodine-131) that occurred on March 18, 1996, at Northwest X-Ray Services, Southfield, Michigan. Northwest X-Ray Services is one of three locations authorized by the NRC Materials License issued to Universal Imaging, Inc., for the use of licensed materials. On April 26, 1996, the NRC was notified of the misadministration. The inspection report was mailed to Universal Imaging, Inc., on June 18, 1996, and a predecisional enforcement conference was held on July 3, 1996.

Based on the information developed during the inspection and the information provided during the conference, the NRC has determined that significant 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 misadministration occurred when the wrong radiopharmaceutical, iodine-131, was administered to a patient, instead of iodine-123. The inspection identified several violations of NRC requirements including the failures to: (1) establish and implement a system for ordering and receiving radioactive material; (2) verify that the material received was the material ordered; (3) provide required training; and (4) provide a timely and complete report of the event.

The NRC entrusts responsibility for radiation safety to the management of Universal Imaging, Inc. Therefore, the NRC expects effective management and oversight of its licensed program. Incumbent upon each NRC licensee is the responsibility to protect the public health and safety by assuring that all requirements of the NRC license are met and any potential violation of NRC requirements is identified and expeditiously corrected. In this case, a nuclear medicine technologist recognized on March 18, 1996, that iodine-131 had been received for the patient; however, iodine-123 was routinely used for the procedure. Notwithstanding the difference noted between the material received and the material normally used, the technologist administered the wrong radiopharmaceutical. Furthermore, on March 25, 1996, an authorized user identified that a misadministration occurred, but did not inform the Radiation Safety Officer (RSO). The misadministration was rediscovered on April 26, 1996, by a consultant during review of radiopharmaceutical use logs.

The various errors causing and following the event demonstrate that ineffective and insufficient management oversight of the implementation of the radiation safety program exists at Universal Imaging, Inc. The violations represent a breakdown in the control of licensed activities involving a number of violations that are related that collectively represent a potentially significant lack of attention toward licensed responsibilities. 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 $2,500 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions 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 the Corrective Action factor was warranted because of the timely and thorough actions taken, including, but not limited to: notified the nuclear pharmacy that iodine-125 and iodine-131 should not be delivered; implemented a procedure that future orders of radiopharmaceuticals will be made by facsimile rather than by telephone; instructed technologists not to start a procedure if the technologist had questions; and appointed a new RSO who will provide job specific training to the authorized users and the technologist. In addition during a conversation on July 31, 1996, you agreed to amend the license to remove the authorization to use iodine-125 and iodine-131.

Therefore, to encourage prompt comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action, I have decided not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty.

One other potential violation of NRC requirements was identified during the inspection. This issue concerned the failure to notify the patient, or the patient's representative, of the misadministration in accordance with 10 CFR 35.33(a)(2). The intent of the notification requirement was discussed during the predecisional enforcement conference and the patient was subsequently notified. Therefore, the NRC is not citing a violation of 10 CFR 33(a)(2).

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC 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). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 030-33326
License No. 21-26532-01

Enclosure: Notice of Violation

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NOTICE OF VIOLATION

Universal Imaging, Inc. Taylor, Michigan

Docket No. 030-33326 License No. 21-26532-01 EA 96-157

During an NRC inspection conducted from April 29 to June 10, 1996, 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:

A. License Condition 16.A to NRC License No. 21-26532-01, Amendment No. 2, requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated September 15, 1993.

1. Item No. 10.6.2.a. of the application dated September 15, 1993, requires the Radiation Safety Officer establish and maintain a system for ordering and receiving radioactive material that includes: (1) written records that identify the authorized user or department, isotope, chemical form, activity, and supplier; and (2) the records will be checked to confirm that the material received was ordered through proper channels.

Contrary to the above, the licensee failed to maintain a system for ordering and receiving radioactive material that includes: (1) written records that identify the authorized user or department, isotope, chemical form, activity, and supplier; and (2) the records will be checked to confirm that the material received was ordered through proper channels. Specifically, 300 microcuries of sodium iodide-131 was received by the licensee on March 18, 1996 at the Northwest X-Ray facilities and written records did not identify: the authorized user, department or chemical form and the records were not checked to confirm that material received was ordered through proper channels. (01013)

2. Item 10.7.6 of the application dated September 15, 1993, requires, in part, that the licensee will verify that the material received is the material ordered.

Contrary to the above, the licensee received licensed material on March 18, 1996 and did not verify that the material received was the material ordered. (01023)

3. Item 8.1 of the application dated September 15, 1993, requires, in part, that before assuming duties, all radiation workers and ancillary personnel whose duties will require them to work in the vicinity of radioactive materials will receive instruction in the following instruction topics: (1) applicable regulations and license conditions, (2) areas where radioactive material is used or stored, (3) potential hazards associated with radioactive material in each area where the employees will work, (4) appropriate radiation safety procedures, and (5) the licensee's in-house work rules.

Contrary to the above, prior to April 26, 1996, the licensee failed to provide the above required training to a radiation worker, a nuclear medicine technologist, before allowing the individual to assume duties in December 1995. (01033)

B. License Condition 16.B to NRC License No. 21-26532-01, Amendment No. 2, requires that the licensee conduct its program in accordance with the statements, representations, and procedures contained in letters dated January 11, 1994 and February 16, 1995.

1. The letter dated January 11, 1994, requires, in part, that the licensee will not administer quantities greater than 30 microcuries of sodium iodide-131 or iodide-125.

Contrary to the above, on March 18, 1996, the licensee administered 200 microcuries of sodium iodide-131 for a diagnostic test. (02013)

2. Item 3. of the letter dated February 16, 1995, requires, in part, that Lawrence G. Wayburn, M.D., will spend at least four hours per week at the Northwest X-Ray Clinic location to fulfil his responsibility as Radiation Safety Officer.

Contrary to the above, prior to March 18, 1996, Lawrence G. Wayburn, M.D., was not present at the Northwest X-Ray Clinic location at least four hours per week to fulfil his responsibility as the Radiation Safety Officer. (02023)

C. 10 CFR 35.33(a) requires, in part, that, for a misadministration, the licensee notify by telephone the NRC Operations Center not later than the next calendar day after discovery of the misadministration. 10 CFR 35.2 defines, in part, "misadministration," to mean a radiopharmaceutical dosage greater than 30 microcuries of either sodium iodide I-125 or I-131 involving the wrong radiopharmaceutical.

Contrary to the above, on March 25, 1996, the licensee became aware that a misadministration occurred and the licensee did not notify the NRC Operations Center until April 26, 1996, which was later than the next calendar day. Specifically, on March 18, 1996, 200 microcuries of iodine-131 were administered to a patient instead of iodine-123. (03013)

D. 10 CFR 35.33(a)(2) requires, in part, that for a misadministration the licensee must submit a written report to the appropriate NRC Region Office (NRC Region III) within 15 days of discovery of the misadministration.

Contrary to the above, the licensee failed to provide to the NRC Region III Office a written report concerning a misadministration of iodine-131 within 15 days of the discovery of the incident. Specifically, on March 25, 1996, the licensee discovered that a misadministration of iodine-131 had occurred on March 18, 1996, and the licensee did not file the written report of the event until May 16, 1996, which is a period in excess of 15 days. (04013)

This is a Severity Level III problem (Supplement III).

Pursuant to the provisions of 10 CFR 2.201, Universal Imaging, Inc. 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 III, 801 Warrenville Road, Lisle, Illinois 60532-4351 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.

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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.

Dated at Lisle, Illinois
this 2nd day of August 1996