EA-03-125 - Doylestown Hospital

June 26, 2003

EA 03-125

Mr. Richard Reif
Chief Executive Officer
Doylestown Hospital
595 West State Street
Doylestown, PA 18901

SUBJECT:

NOTICE OF VIOLATION (NRC Inspection Report No. 030-03186/2003-001)

Dear Mr. Reif:

This refers to the NRC inspection conducted on April 3, 2003, at your facility in Doylestown, Pennsylvania to review an incident that occurred on March 25, 2003. The incident was reported to the NRC by your staff on March 26, 2003, as a possible medical event. The NRC inspection was continued in the NRC Region I Office until May 29, 2003, to examine additional information provided by Doylestown Hospital and to review a report regarding the potential medical event written by an NRC medical consultant.

During the NRC inspection, an apparent violation of NRC requirements was identified. The apparent violation, which was described to you during an exit interview on April 3, 2003, and by telephone on June 19, 2003, involved the use of an intravascular brachytherapy (IVB) system containing phosphorus-32 by a radiation oncologist and a cardiologist who had not completed the manufacturer's training prior to using the new IVB system for patient treatments. As a result, an incident occurred involving the delivery of a dose to a patient that was greater than originally prescribed. The incident occurred when your staff encountered difficulty using the new IVB system for patient treatments.

On June 19, 2003, Ms. Pamela Henderson of the NRC Region I staff, held a telephone conversation with Mr. James Brownlow, Chief Operating Officer, and others of your staff, indicating that the NRC did not need any additional information to make an enforcement decision regarding this violation. However, Ms. Henderson provided Doylestown Hospital an opportunity to attend a predecisional enforcement conference or to provide a written response prior to the NRC determining appropriate enforcement action in this case. During that conversation, Mr. Brownlow declined the opportunity to attend a conference or to provide a written response.

Based on the information developed during the inspection, the NRC has determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation (Notice) and is described in detail in the subject inspection report. The violation occurred on March 25, 2003, when your staff used, for the first time, a new Guidant Corporation Galileo III IVB system, containing 198 millicuries of phosphorus-32, to treat a lesion on a patient's vessel wall. Although the vendor representative was available to provide training on the new system, and was also in attendance during the treatment to provide guidance, your staff started a patient treatment without first completing the required training. During the first and second attempts to treat the patient, your staff recognized that the system was not correctly positioned and stopped the procedure after the second treatment. As a result, these IVB treatments delivered only 830 cGy maximum to some portion of the target area, rather than the prescribed dose of 2000 cGy. Since the entire target area did not receive the prescribed dose, your staff decided to proceed with a third treatment in the targeted area, during which the system was correctly positioned and the prescribed dose of 2000 cGy was delivered. However, delivering the third treatment of 2000 cGy to the target area resulted in some areas of the lesion receiving a dose of as much as 2833 cGy, 41% greater than the originally prescribed dose. The written directive was subsequently revised within 24 hours to increase the dose prescribed to the patient to the amount that was delivered. Because there was no medical consequence to the patient, this incident is not classified as a medical event.

Your staff did not identify any harm to the patient. In addition, the medical consultant, who reviewed a description of the facts associated with this case, did not expect any adverse health effects. Nonetheless, the failure to complete manufacturer's training prior to use of the IVB system represented a substantial failure to follow procedures because there was an increased potential for a medical event to occur. Therefore, the violation described in the attached Notice is 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 $3,000 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement action within the last two years or two inspections, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions, once the violations were identified during the inspection, were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) immediately providing the manufacturer's training to the oncologist and cardiologist prior to their further use of the IVB system; (2) informing all other potential users that manufacturer's training is required prior to using a new procedure or device; and (3) implementing monitoring of the staff by management personnel to ensure compliance.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation for the Severity Level III violation with no civil penalty. However, you should be aware that significant violations in the future could result in a civil penalty. In addition, issuance of this Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

Since your actions taken and planned to correct the violations and prevent recurrence have been described as documented in this letter and in the subject inspection report, you are not required to respond to this letter unless the description of those actions is not accurate. 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, its enclosures, and your response (if you choose to provide one) will be made 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 the Public NRC Library.

		Sincerely,
		/RA/ James T. Wiggins Acting For
		Hubert J. Miller Regional Administrator

Docket No. 03003186
License No. 37-13232-01

Enclosures:
1. Notice of Violation
2. NRC Region I Inspection Report 03003186/2003-001

cc w/encl:
Commonwealth of Pennsylvania

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ENCLOSURE

NOTICE OF VIOLATION

Doylestown Hospital Doylestown, Pennsylvania

Docket No. 03003186 License No. 37-13232-01 EA 03-125

During an NRC inspection conducted on April 3, 2003, and continued in the NRC Region I Office until May 29, 2003, one violation of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violation is listed below:

Condition No. 18 of License No. 37-13232-01 requires, in part, that the licensee shall conduct its program in accordance with statements, representations, and procedures contained in the letter dated April 10, 2001.

The letter dated April 10, 2001, states, in part, that the licensee will complete the manufacturer's training prior to use of the intravascular brachytherapy system.

Contrary to the above, on March 25, 2003, the licensee received an upgraded Guidant Corporation GALILEO III intravascular brachytherapy (IVB) system containing 198.2 millicuries of phosphorus-32, and used that IVB system to treat a patient, and the oncologist and cardiologist who used the system did not complete the manufacturer's training prior to use. The failure to train staff prior to use of the upgraded system resulted in the patient receiving 40% more dose than originally prescribed to a portion of the lesion of the vessel being treated.

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

The NRC has concluded that information regarding the reason for the violation, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed on the docket in the NRC letter transmitting this Notice. Therefore, no response to this Notice is required. 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, EA 03-125" 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 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.

If you choose to respond, your response will be made 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 the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 26th day of June 2003