EA-02-148 - Temple University
July 25, 2002
Leon S. Malmud, M.D.
Senior Vice President
Department of Environmental Health
and Radiation Safety
3307 North Broad Street, Room B-49
Philadelphia, PA 19140
|SUBJECT:||NOTICE OF VIOLATION (NRC Office of Investigations Report 1-2001-018)|
Dear Dr. Malmud:
This letter refers to an investigation conducted by the NRC's Office of Investigations (OI) at Temple University Hospital (TUH), to determine if a senior nuclear medicine technologist (SNMT) deliberately mixed two different radiopharmaceuticals together for a patient dose on March 13, 2001, and subsequently falsified the assayed and delivered dose record. This OI investigation was initiated after TUH informed the NRC in April 2001 that it had identified that the SNMT had mixed doses of two different pharmaceuticals, and was then involved in recording the dose as having come from only the one pharmaceutical that was intended to be used. The OI investigation was completed on June 6, 2002.
On July 11, 2002, Ms. Pamela Henderson, of the NRC Region I staff, held a telephone conversation with Dr. Howard Grant, and other members of your staff, indicating that the NRC was considering escalated enforcement action for apparent violations involving failure by the SNMT to follow the instructions of the authorized user and failure to maintain accurate records. Ms. Henderson also informed your staff that we had sufficient information regarding the apparent violations and your corrective actions to make an enforcement decision without the need for a predecisional enforcement conference or a written response from you regarding this matter. However, Ms. Henderson provided you an opportunity to attend a predecisional enforcement conference or provide a written response prior to the NRC determining appropriate enforcement action in this case. During that conversation, your staff declined a conference or opportunity for a written response.
Based on its investigation, a synopsis of which is attached, OI concluded that the SNMT knowingly disregarded TUH procedures and caused a violation regarding the maintenance of complete and accurate information. Based on the OI findings, the NRC has determined that two violations of NRC requirements occurred. The violations are being cited in the enclosed Notice of Violation (Notice). The first violation involved the deliberate failure by the SNMT to follow the instructions of the authorized user, contrary to the requirements set forth in 10 CFR 35.25. The second violation involves the falsification of records required to be maintained pursuant to 10 CFR 35.53, and also required to be accurate pursuant to 10 CFR 30.9.
The safety consequences of these violations were low because the dose administered to the patient was still within the clinical dose range, and there were no adverse effects on the patient. However, the violations were considered "more than minor" within the context of the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, because mixing radiopharmaceuticals and not accurately recording dose information could result in a radiation dose to unintended organs or areas of the body, as well as potential errors in the diagnosis of patients. Therefore, in accordance with the Enforcement Policy, these violations would normally be classified at Severity Level IV. However, given the willful nature of the violations, they are classified together as a Severity Level III problem.
If the violations had been classified at a Severity Level IV due to a lesser safety significance, they would have been treated as Non-Cited Violations (NCVs) in consideration of your efforts in identifying and correcting the violations. Nonetheless, since the violations are classified at Severity Level III, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation or problem in accordance with the Enforcement Policy. Because your facility has been the subject of an escalated enforcement action within the last two years (an $8,800 civil penalty was issued on October 19, 2000, for other violations of NRC requirements), and because the violations in the enclosed Notice were willful, the NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for Identification is warranted since the violations were identified by your staff and reported to the NRC. Credit for Corrective Action is also warranted because your corrective actions were considered prompt and comprehensive. These actions included, but are not limited to: (1) conducting a prompt investigation of this matter; (2) terminating the employment of the responsible SNMT; and, (3) training all technical staff in the Nuclear Medicine Department regarding radiation safety topics that included proper recording of doses, integrity of records, completeness and accuracy of information, and instructions for administration of doses to patients.
Therefore, to encourage prompt identification and comprehensive correction of violations, 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 this Severity Level III problem constitutes escalated enforcement action, that may subject you to increased inspection effort.
The NRC has concluded that information regarding your corrective actions taken and planned to correct and prevent recurrence of the violations set forth in the enclosed Notice, has been described as documented in this letter. Therefore, you are not required to respond to this letter unless the description herein does not accurately 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. We appreciate your cooperation with us in this matter.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter and its enclosure will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records (PARS) component of NRC's document system (ADAMS). ADAMS is accessible from the NRC Web Site at http://www.nrc.gov/reading-rm.html (the Public NRC Library).
|/RA/ James T. Wiggins Acting For
|Hubert J. Miller
Docket No.: 03002963
License No.: 37-00697-31
1. Synposis from NRC Investigation 1-2001-0182
2. Notice of Violation
NOTICE OF VIOLATION
|Docket No. 03002963
License No. 37-00697-31
During an NRC investigation completed by the NRC Office of Investigation on June 6, 2002, two 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 35.25(b)(2), states that a licensee that permits
the preparation of byproduct material for medical use by an individual
under the supervision of an authorized nuclear pharmacist or physician
who is an authorized user as allowed by 10 CFR 35.11(c) of this part,
shall require the supervised individual to follow the instructions
given for the preparation of the byproduct material for medical use,
the principles of and procedures for radiation safety, and the licensee's
written quality management program.
Contrary to the above, on March 13, 2001, a supervised individual prepared unsealed byproduct material for medical use on a patient, and the supervised individual did not follow the instructions given for the preparation of byproduct material. Specifically, the authorized user's approved procedures specified use of a dose of technetium-99m (in the form of sulfur colloid) between 5 and 8 millicuries for the requested medical procedure. However, since the activity of the technetium-99m in the sulfur colloid had decayed below 5 millicuries at the time the dose was to be delivered to a patient, the supervised individual added 2 millicuries of technetium pertechnetate to the sulfur colloid to increase the activity to 7 millicuries, without obtaining approval to do so from the authorized user.
|B.||10 CFR 30.9(a) requires, in part, that information provided to the
Commission by a licensee, or information required by the Commission's
regulations to be maintained by the licensee, shall be complete and
accurate in all material respects.
10 CFR 35.53(c), requires in part, that each licensee measure the activity of each dosage of a photon-emitting radionuclide prior to medical use and retain a record of the measurements required by this section for three years. The record must include in part, generic name, trade name, or abbreviation of the radiopharmaceutical, its lot number, and expiration dates and the radionuclide.
Contrary to the above, on March 13, 2001, information required by the Commission's regulations to be maintained by the licensee was not complete and accurate. Specifically, the dose measurement records required by 10 CFR 35.53 for a technetium dose provided to a patient, contained an entry for March 13, 2001, identifying the name and lot number of sulfur colloid as a delivered dose when, in fact, sulfur colloid and technetium pertechnetate were mixed (resulting in the delivery of two radiopharmaceuticals with different lot numbers), and the name and lot number of technetium pertechnetate was not recorded as required.
This is a Severity Level III problem (Supplements VI & VII).
The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violations and prevent recurrence are already adequately addressed on the docket in the NRC letter transmitting this Notice. 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 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, DC 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).
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.
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 or proprietary information so that it can be placed 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 25th day of July 2002