EA-96-247 - EquiMed, Inc.

> Materials Licensees

November 7, 1996

EA 96-247

David J. Moylan, III, M.D.
Medical Director and Radiation
Safety Officer
EquiMed, Inc.
800 Mahoning Street, Suite E
Lehighton, Pennsylvania 18235

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-33333/96-001)

Dear Dr. Moylan:

This letter refers to the NRC inspection conducted on June 24 and 25, 1996, at your facility in Lehighton, Pennsylvania, and to an exit meeting conducted by telephone, with you on September 23, 1996. The inspection was conducted to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. During the inspection, apparent violations of NRC requirements were identified, and were described in the NRC inspection report transmitted with our letter dated September 27, 1996.

In the September 27, 1996 letter, the NRC provided you with an opportunity to either respond in writing to the apparent violations addressed in the inspection report or request a predecisional enforcement conference, within 21 days of the letter. You responded to the apparent violations in a letter to the NRC dated October 11, 1996.

Based on the information developed during the inspection and the information you provided in your October 11, 1996 response, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and circumstances surrounding them are described in detail in the subject inspection report. The first violation involves your failure to follow your Quality Management Program (QMP) which caused two patient misadministrations to occur. The misadministrations occurred on December 31, 1995 while two patients were being treated using the High Dose Rate Remote Afterloader (HDR). Prior to the treatments, the transfer of data from the treatment planning computer had not been adequately checked by the person entering the data into the control console and the authorized user did not verify the accuracy of the data. As a result, an error in the data entry for source positions had not been identified. You concluded that each patient received 312 rads, instead of the prescribed dose of 500 rads and a mean dose to an additional 5 centimeters length (that was not intended to be treated) was 312 rads.

Given that this violation of your QMP Program contributed to two therapeutic misadministrations, this violation has been categorized at Severity Level III in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III violation. Because EquiMed, Inc. has not been the subject of an escalated enforcement action 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 corrective action is warranted because your actions were both prompt and comprehensive. These actions, which were noted in your October 11, 1996 letter included, but were not limited to: (1) initiating a new requirement for all HDR treatments requiring the authorized user and authorized physicist to remove the pre-treatment print-out from the treatment console, review the parameters input to the computer, and initial the print-out before initiating the treatment; and (2) reviewing the QMP in detail to identify other potential weaknesses in the program. The QMP will be rewritten, after the review is completed, to conform to current standards and to incorporate the necessary changes identified in the review.

Therefore, to emphasize prompt identification and comprehensive correction of violations when they exist, 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.

The second violation involves your failure to notify the NRC no later than the next working day after the discovery of the misadministrations, and to submit a written report to the NRC and the patient within 15 days after discovery of the misadministrations. These misadministrations were both discovered on January 5, 1996. You did not notify the NRC until July 3, 1996, of either misadministration. In addition, the written report was not submitted until July 12, 1996. While this violation has been categorized in accordance with the Enforcement Policy at Severity Level IV, the NRC is concerned that it did not become aware of the misadministrations until the June inspection because of your failure to report the misadministration as required. Any similar violations of reporting requirements in the future could result in escalated enforcement action.

The NRC has concluded that the information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence, and the date of compliance are already addressed adequately on the docket in Inspection Report 030-33333/96-001, dated September 27, 1996, and your letters dated July 12, 1996, and October 11, 1996. 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, 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 I, within 30 days of the date of the letter transmitting this Notice.

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

Sincerely,

Hubert J. Miller Regional Administrator

Docket No. 030-33333
License No. 37-30086-01

Enclosure: Notice of Violation

cc w/encl:
Commonwealth of Pennsylvania

---

NOTICE OF VIOLATION

EquiMed, Incorporated Lehighton, Pennsylvania

Docket No. 030-33333 License No. 37-30086-01 EA 96-247

During an NRC inspection conducted on June 24 and 25, 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. 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.

The licensee's Quality Management Program (QMP) for the administration of high dose rate (HDR) brachytherapy was submitted to NRC by a letter dated September 15, 1994, and requires, in part, that prior to treating the patient with the HDR, the transfer of data from the treatment planning computer (e.g., channel number, source positions, and treatment times) be checked by the person entering the data in the control console, and verified by the authorized user.

Contrary to the above, on December 31, 1995, prior to the HDR treatment of two patients, the transfer of data from the treatment planning computer (i.e., channel number, source positions, and treatment times) was not adequately checked by the person entering the data in the control console and verified by the authorizer user. Specifically, the check did not identify an error in the data entry for source positions, in that, the stepping distance entered was 10 millimeters instead of the computer generated stepping distance of 5 millimeters. Consequently, two patients were administered 312 rads to 5 additional centimeters of tissue which was not prescribed to receive such a dose. (01013)

This is a Severity Level III violation (Supplement VI).

B. 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 35.33(a)(2) and (a)(4) require, in part, that a written report be submitted to the NRC and to the patient within 15 days after discovery of the misadministration.

Contrary the above, although the two misadministrations occurred on December 31, 1995, the licensee did not notify, by telephone, the NRC Operations Center by the next working day after the discovery of the misadministrations and did not submit a written report to the NRC and to the patient, within 15 days after discovery of the misadministrations. Specifically, the misadministrations were discovered on January 5, 1996, and the telephone notification to the NRC Operations Center was not made until July 3, 1996, and the required, written report was not submitted until July 12, 1996. (02014)

This is a Severity Level IV violation (Supplement VI).

The NRC has concluded that information regarding the reason for the violation, the corrective actions taken and planned to correct the violation and prevent recurrence was adequately addressed in your letters dated July 12, 1996, and October 11, 1996. 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, D.C. 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).

Dated at King of Prussia, Pennsylvania
this 7th day of November 1996