EA-95-243 - Temple University

March 5, 1996

EA 95-243

Mr. James White
Executive Vice President
Temple University
3307 North Broad Street
Philadelphia, Pennsylvania 19140

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report Nos. 030-00458/95-003 and 030-02963/95-003)

Dear Mr. White:

This refers to the special inspection conducted on October 5,18, and 19, 1995, at your Philadelphia, Pennsylvania facility. The purpose of the inspection was to determine whether activities authorized by your NRC licenses were conducted safely and in accordance with NRC requirements and to review the circumstances surrounding a reported therapeutic misadministration involving a cobalt-60 teletherapy irradiation, which you identified on September 28, 1995, the fourth day of the treatment. One apparent violation of NRC requirements was identified during the inspection. At the conclusion of the inspection, the findings were discussed with Donald Redmond, Acting Director, Environmental Health and Safety, and other members of your staff. On February 7, 1996, a Predecisional Enforcement Conference was conducted with Leon Malmud, M.D., Sr. Vice President, and other members of your staff as well as Robert Scanlon, Vice President, Salick Health Care, Inc. to discuss the violation, its cause, and your corrective actions.

Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that a violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involves the failure of certain staff members to follow your Quality Management Program Procedures.

Your Quality Management Program (QMP) requires that the Treatment Plan General Order Forms serve as the written directive for teletherapy applications and that all calculations relating to target dose, beam-on-time, and doses to various sites of interest, whether performed by hand or by computer, will be checked by a hand calculation by a person, preferably a member of the physics staff, who did not perform the original calculation. These calculations are required to be checked prior to initial patient treatment. Your QMP also requires that if a written directive is vague or unclear or inconsistent with the treatment plan, the technologist should immediately notify (a) the chief technologist, (b) physics or dosimetry staff, and (c) the staff radiation oncologist.

On September 22, 1995, a written directive prescribing 2000 centigrays (cGy) to a patient in five treatment fractions was prepared by an authorized user in order to treat a patient's left shoulder and scapula. The authorized user entered two treatment fields, on a space on the form designated for one field, by using A/B under field ID on the Treatment Plan General Orders Form. In addition, the physics staff performed a review of the target dose and beam-on-time. The review did not identify that the treatment time had been calculated to deliver 400 cGy for each of the two treatment fields, instead of the intended dose of 200 cGy for each of the two fields. Furthermore, the review did not identify that the daily target dose was written as 500 cGy instead of the intended dose of 400 cGy. On September 26, 1995 the technologist noted 500 cGy on the treatment sheet, changed it to 400 cGy, and treated the patient but failed to immediately notify the chief technologist, and the staff radiation oncologist. These failures to adequately implement your quality management program contributed to the patient receiving 2,724 centigrays in four treatment fractions, instead of the intended dose of 2,000 centigrays in five treatment fractions, which is defined in 10 CFR 35.2 as a misadministration.

Given that three opportunities existed to preclude this misadministration, failure to do so represents a programmatic weakness in the implementation of your quality management program. A programmatic weakness in the implementation of a quality management program that results in a misadministration as specified in the Enforcement Policy is classified at a Severity Level III violation. Therefore, this violation has been categorized in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600; at Severity Level III.

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 your facility has been the subject of escalated enforcement actions within the last two years, 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 and corrective actions is warranted because you identified the misadministration and the issues associated with the subsequent violation. Your corrective actions were both prompt and comprehensive. These actions, which were noted in the inspection report included, but were not limited to the following: (1) using only the new prescription forms which list the prescribed doses for each separate field; (2) requiring the attending physician or resident to review the timer setting or monitor unit calculations when programming the chart, to confirm that they are in agreement with the prescription; (3) providing additional training, including but not limited to the requirements of the Temple University Quality Management Program, to all departmental staff involved with the administration of radiation to patients; and (4) requiring that the individual performing chart checks indicates that the calculations and treatment plan have been reviewed for potential double dosing errors.

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, similar violations in the future could result in a civil penalty.

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 and the date of compliance already was addressed adequately on the docket in Combined Inspection Report Nos. 030-00458/95-003 and 030-02963/95-003, issued November 16, 1995, and your letter dated December 15, 1995. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not reflect your corrective actions or your position accurately. It should be noted that your letter, dated December 15, 1995, indicates that you contest the violation. We believe based on the discussions during the predecisional enforcement conference that your position has changed, that you no longer contest the violation, and therefore, will need to respond as to whether you admit or deny the violation as stated in this Notice of Violation (Notice). 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). 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.

The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96-511.

Sincerely, Thomas T. Martin Regional Administrator

Docket Nos. 030-00458; 030-02963
License No. 37-00697-02; 37-00697-31

Enclosure: Notice of Violation

cc w/Enclosure:
Kurt Bodison, Acting Radiation Safety Officer
Linda Knight, Chairperson, Radiation Safety Committee Commonwealth of Pennsylvania

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NOTICE OF VIOLATION

Temple University Philadelphia, Pennsylvania

Docket Nos. 030-00458; 030-02963 License Nos. 37-00697-02; 37-00697-31 EA 95-243

During an NRC inspection conducted on October 5, 18 and 19, 1995, a violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG-1600, the violation is listed below:

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.

Pursuant to 10 CFR 35.32(a)(4), the quality management program must include written policies and procedures to meet the specific objective that each administration is in accordance with a written directive.

The licensee's Quality Management Program (QMP) for the administration of teletherapy dated January 24, 1992, and a revised QMP, dated October 25, 1994, states, in part, that: (1) all calculations relating to target dose, beam-on-time, and doses to various sites of interest, whether performed by hand or by computer, will be checked by a hand calculation, by a person, preferably a member of the physics staff, who did not perform the original calculation, and that calculations will be checked prior to being used for patient treatment to verify that calculations/doses are adhering to the physician's prescription; and (2) if a written directive is vague or unclear or inconsistent with the treatment plan, the technologist should immediately notify (a) the chief technologist, (b) physics or dosimetry staff, and (c) the staff radiation oncologist.

Contrary to the above, on September 22 and 26, 1995, procedures established as part of the licensee's Quality Management Program were not followed, as evidenced by the following examples. Specifically,

1. on September 22, 1995, a member of the physics staff, who did not perform the original calculations of the target dose, beam-on-time, and doses to various sites of interest, in a cobalt-60 treatment to a patient on that date, did not adequately check, by a hand calculation, all calculations related to those parameters. The check was not adequate in that:

a. it did not identify that the daily treatment time was calculated to deliver 400 centigray to each of the two treatment fields, instead of the intended dose of 200 centigray to each of the two fields; and

b. it did not identify that the daily target dose was written as 500 centigray instead of the intended dose of 400 centigray.

2. on September 26, 1995, the technologist noted 500 cGy on the treatment sheet for the patient, and changed it to 400 cGy and treated the patient without immediately notifying the chief technologist, and the staff radiation oncologist. (01013)

This is a Severity Level III 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 and the date of compliance already was addressed adequately on the docket in Combined Inspection Report Nos. 030-00458/95-003 and 030-02963/95-003, issued November 16, 1995. 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. It should be noted that your letter dated December 15, 1995, indicates that you contest the violation. We believe based on the discussions during the predecisional enforcement conference that your position has changed and that you no longer contest the violation and therefore will need to respond in order to admit the violation as stated in this Notice of Violation (Notice). 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.

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 King of Prussia, Pennsylvania
this 5th day of March 1996