EA-97-111 - Midwest Imaging Diagnostic, Inc. Ltd.
Harold T. Pretorius, M.D., Ph.D.
Midwest Imaging Diagnostic, Inc. Ltd.
111 Wellington Place
Cincinnati, OH 45219
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-34230/97001(DNMS))
Dear Dr. Pretorius:
This refers to the inspection conducted on February 12, 1997, with continuing
NRC review through February 24, 1997, at the Midwest Imaging Diagnostic,
Inc. Ltd. (MIDI) facility in Cincinnati, Ohio. The purpose of the inspection
was to determine whether activities authorized by your NRC license were
being conducted safely and in accordance with NRC requirements. Our findings
were documented in an inspection report sent to you by letter dated March
19, 1997. On April 10, 1997, a predecisional enforcement conference was
held in the NRC Region III office with you and Dr. K. Patel to discuss
the violations, their causes, and proposed corrective actions.
Based on the information developed during the inspection and the information
that you provided during the conference, 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.
Six violations were identified during the NRC inspection and, collectively,
they are indicative of a serious lack of attention to program responsibilities.
While all are of significant regulatory concern, two of the violations,
unauthorized use of iodine-131 and failure to establish and maintain a
written quality management program (QMP), are particularly egregious.
Normally the failure to implement a written QMP would by itself be considered
a severity level III violation. However, in this case we will not do so
because we understand that you personally assayed the iodine-131 doses,
administered the iodine-131 to the patients, prepared written directives,
and used two methods of patient identification.
The root cause of these violations is that licensee representatives, including the radiation safety officer (RSO), did not have a thorough knowledge and understanding of the license requirements. This is particularly disturbing to the NRC since as a new licensee we expected all MIDI staff, the RSO in particular, to be quite knowledgeable of the license requirements and concerned about compliance with those requirements. Incumbent upon each NRC licensee is the responsibility to protect public health and safety by ensuring that all NRC requirements are met and any potential violations of NRC requirements are identified and expeditiously corrected. 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 $2750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last 2 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 Action was warranted based upon your presentations at the April 10, 1997, predecisional enforcement conference. MIDI has taken and/or plans to take the following actions: (1) use of all iodine-131 has been discontinued; (2) an amendment request has been submitted to NRC to add the use of iodine-131 for therapeutic purposes; (3) a written QMP has been submitted to NRC for review; (4) extremity monitoring devices have been obtained and are currently in use; (5) an outside consultant has been employed to assist in periodic program reviews; and (6) MIDI staff have reviewed all license documents and regulatory requirements pertaining to its NRC license.
Therefore, to encourage prompt and comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, 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 problem constitutes escalated enforcement action that may subject you to increased inspection effort.
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, A. Bill Beach Regional Administrator
Docket No. 030-34230
License No. 34-26753-01
Midwest Imaging Diagnostic, Inc., Ltd. Docket No. 030-34230 Cincinnati, Ohio License No. 34-26753-01 EA 97-111
During an NRC inspection conducted on February 12, 1997, with in-office review through February 24, 1997, 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:
1. 10 CFR 35.13(a) requires that a licensee apply for and must receive a license amendment before it receives or uses byproduct material for a clinical procedure permitted under 10 CFR Part 35 but not permitted by the license issued pursuant to 10 CFR Part 35.
Contrary to the above, as of February 12, 1997, the licensee received and used byproduct material on four occasions for hyperthyroidism treatments, a clinical procedure permitted under 10 CFR Part 35 but not permitted by the licensee's license issued pursuant to 10 CFR Part 35; and, as of that date, the licensee had not applied for a license amendment authorizing the performance of this procedure. (01013)
2. 10 CFR 35.32(a) requires, in part, that the licensee establish and maintain a written quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by the authorized user.
Contrary to the above, on November 8, 1996, January 2, 1997, February 5, 1997, and February 6, 1997, the licensee used iodine-131 in quantities greater than 30 microcuries for treatment of hyperthyroidism, and the licensee had not established a written quality management program. (01023)
3. 10 CFR 35.50(b)(4) requires, in part, that a licensee test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used.
Contrary to the above, the licensee did not test its dose calibrator (Atomlab Model 100, Serial Number 1380002) for geometry dependence at the time of installation, which occurred on or about October 29, 1996. (01033)
4. 10 CFR 35.70(e) requires that a licensee survey for removable contamination once each week all areas where radiopharmaceuticals are routinely prepared for use, administered, or stored.
Contrary to the above, between November 6, 1996 and December 9, 1996, for example, the licensee did not survey for removable contamination in the hot lab, production lab and scan room, areas where radiopharmaceuticals were routinely prepared, administered and stored. (01043)
5. Condition 16. of License No. 34-26753-01 requires that licensed material be possessed and used in accordance with statements, representations, and procedures contained in a letter received October 10, 1996.
Item 9.4 of this letter requires that exposures to the extremities of "radiation workers" (radiochemists and medical technologists) be evaluated by the use of finger ring badges.
Contrary to the above, as of February 12, 1997, finger ring badges had not been assigned to evaluate the dose to the extremities of a technologist preparing and administering radiopharmaceuticals. (01053)
6. 10 CFR 35.70(a) requires that a licensee survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administration. Further, 10 CFR 35.70(h) requires the licensee to retain a record of each survey for three years.
Contrary to the above, as of February 12, 1997, the licensee has not maintained records of area surveys performed at the end of each day of radiopharmaceutical use. (01063)
These violations represent a Severity Level III problem. (Supplement VI)
Pursuant to the provisions of 10 CFR 2.201, Midwest Imaging Diagnostic, Inc., Ltd. 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, 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. 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). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.
Dated at Lisle, Illinois
this 1st day of May 1997