EA-99-246 - Holy Redeemer Hospital and Medical Center

November 3, 1999

EA 99-246

Ms. Cass Egan
Vice President
Holy Redeemer Hospital and Medical Center
1648 Huntingdon Pike
Meadowbrook, PA 19406

SUBJECT:  NOTICE OF VIOLATION (NRC Inspection Report No. 030-03044/99-01)

Dear Ms. Egan:

This refers to the NRC inspection conducted on September 17, 1999, at your facility in Meadowbrook, Pennsylvania. The inspection was conducted to review the circumstances associated with a misadministration of iodine-131 to a patient at your facility on September 14, 1999. The problem was reported to the NRC by your staff on September 16, 1999. During the inspection, one apparent violation of NRC requirements was identified. The apparent violation was described in our inspection report sent to you on October 6, 1999. We also received a letter from you, dated September 21, 1999, that described your immediate corrective actions taken to prevent recurrence. On October 28, 1999, a predecisional enforcement conference was held with you and other members of your staff to discuss the apparent violation, its causes, and your corrective actions, including long term actions planned after your letter was sent to us and you had completed a quality process review of your procedures. A copy of the enforcement conference report is attached.

Based on the information developed during the inspection, and the information provided in your September 21, 1999 response and during the predecisional enforcement conference, a violation of NRC requirements is being cited. The violation is described in the enclosed Notice of Violation (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation involved the failure to properly implement the Quality Management Program (QMP) for the facility in that a dose was administered to a patient without preparation of a written directive. This violation contributed to a misadministration at your facility when a patient, who was to be evaluated for hyperthyroidism via an uptake procedure using approximately 300 microcuries of iodine-123, was instead administered a 5.3 millicurie dose of iodine-131 for a head and neck study.

The wrong study was conducted due to: (1) an error by the scheduling department where a procedure was scheduled that was different than that prescribed by the referring physician because of ambiguity in the referral slip; (2) failure of the technologist, who received both the referral slip and the procedure schedule, to question the discrepancy; (3) failure of the technologist to obtain and review the patient's history which would have raised questions regarding the need for the procedure; and (4) failure of the technologist to obtain a written directive and follow the established QMP before the dose was administered to the patient. These findings represent programmatic weaknesses in the implementation of your QMP which resulted in a misadministration. Therefore, the violation is categorized as a Severity Level III problem in accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation or problem. Because your facility 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 actions is warranted because your corrective actions, at the time of the predecisional enforcement conference, were considered prompt and comprehensive. These actions include, but are not limited to: (1) adding more detail to the computer scheduling system to indicate the types of treatments available to schedule; (2) review by the nuclear medicine supervisor before an appointment date and time is scheduled for an iodine-131 procedure; (3) verification with the referring physician's office by the nuclear medicine supervisor before the dose is ordered for a scheduled iodine-131 study; (4) witnessing, for one year, by the nuclear medicine supervisor of all iodine-131 treatments performed by the technologist who contributed to the violation; (5) development of standard language for physician referrals and prescriptions; (6) review and signature by the authorized user on the completed written directive prior to the ordering of iodine-131; (7) commitment to resolve any ambiguity in the referring physician request to the satisfaction of the authorized user prior to dose administration; and (8) plans to have the authorized user see all patients for therapeutic iodine-131 treatment (10 millicuries and above) and be physically present during dose administration.

Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

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, were already described adequately during the enforcement conference, and are adequately addressed on the docket in your letter, dated September 21, 1999, or in this letter. Therefore, you are not required to respond to this letter unless the description therein 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.

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

		Sincerely,
		ORIGINAL SIGNED BY: James T. Wiggins for
		Hubert J. Miller Regional Administrator

Docket No. 030-03044
License No. 37-05089-01

Enclosure: Notice of Violationcc w/encls:
Lester H. Wurtele, M.D., Radiation Safety Officer
Commonwealth of Pennsylvania

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ENCLOSURE

NOTICE OF VIOLATION

Holy Redeemer Hospital and Medical Center Meadowbrook, PA

Docket No. 030-03044 License No. 37-05089-01 EA 99-246

During an NRC inspection conducted on September 17, 1999, a 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:

10 CFR 35.25(a)(2) requires, in part, that a licensee that permits the use of byproduct material by an individual under the supervision of an authorized user shall require the supervised individual to follow the written quality management procedures established by the licensee.

The licensee's quality management procedure, dated July 15, 1994, Item 1.0, requires that the authorized user or physician under the supervision of an authorized user must date and sign a written directive for a specific patient prior to administration of any therapeutic dosage of a radio pharmaceutical or any dosage of quantities greater than 30 microcuries of either iodine-125 or iodine-131.

Contrary to the above, on September 14, 1999, the licensee's technologist, an individual who was working under the supervision of the licensee's authorized user, did not follow the written quality management procedures established by the licensee in that no written directive was prepared prior to the administration of iodine-131. As a result, the technologist administered approximately 5 millicuries of iodine-131, instead of the intended dose of approximately 300 microcuries of iodine-123. This resulted in unplanned dose to the patient. (01013)

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

The NRC has concluded that information regarding the reason for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence were adequately described during the enforcement conference on October 28, 1999, and are already adequately addressed on the docket in the NRC letter. 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.