EA-99-289 - St. John Hospital and Medical Center
December 20, 1999
Ms. Diane M. Radloff
Vice President Patient Care Services
St. John Hospital and Medical Center
22101 Moross Road
Detroit, MI 48236-2172
||NOTICE OF VIOLATION
(NRC Inspection Report 030-02028/99001(DNMS))
Dear Ms. Radloff:
This refers to the inspection conducted on October 19 through 23, 1999, at St. John Hospital and Medical Center (St. John) in Detroit, Michigan. The purpose of the inspection was to review the circumstances surrounding a reported radiopharmaceutical misadministration. During the inspection, apparent violations of NRC requirements were identified and were documented in the NRC inspection report sent to you by our letter dated December 1, 1999. In that letter we indicated that NRC had sufficient information to proceed with the enforcement action, however, you were given an opportunity to discuss the apparent violations at a predecisional enforcement conference or address the apparent violations in writing. During a telephone conversation between Dr. W. Nikesch of your staff and Mr. G. Wright of my staff on December 7, 1999, St. John declined a conference and declined to provide additional written correspondence.
Based on the information developed during the inspection and the information provided in your report of misadministration dated October 29, 1999, the NRC has determined that violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice).
Violation A of the Notice is indicative of a weakness in the implementation of the St. John quality management program (QMP). At the request of the authorized user, orders were placed for iodine-131 therapy doses of 250 and 300 millicuries to be administered to two patients. On September 7, 1999, before the completion of the written directives, the acting pharmacy technologist unpacked the two iodine I-131 vials, measured each dose in the dose calibrator (264 and 296.7 millicuries), and printed out the labels with the information regarding the doses and the patients names. Later, the authorized user prescribed a treatment dose of 200 millicuries for patient A and 300 millicuries for patient B. The administering technologist took the written directives for both patients and proceeded to the nuclear pharmacy with patient A. Both doses were re-assayed and the amounts posted on the written directive forms. At that point, the administering technologist failed to compare the ordered dose with the written directive to assure that patient A would receive the proper dose of 200 millicuries. In addition, the second party verification was not performed. As a result of these failures, patient A received a 32 percent overdose. NRC regulations and licensee policies are in place to ensure physician's prescriptions are administered as written. Failure to adhere to these regulations and policies can result in serious consequences to patients. It is imperative that the utmost care and attention to detail are used when dealing with radioactive material. Therefore, violation A of the Notice is classified in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III violation.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, 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 based on the following corrective actions planned or taken: (1) the two technologists involved were prohibited from administering therapy doses until the licensee was satisfied that they had a complete understanding of and could correctly implement the QMP; (2) all individuals involved with the therapy program have received retraining on the QMP including the form revisions; and (3) the written directive form has been modified to clarify the methods of dose verification to be used.
Therefore, to encourage prompt and comprehensive correction of violations and in recognition of the absence of previous escalated enforcement action, I have been authorized 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 the Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.
Violation B of the Notice addresses the release of two patients who had received a therapeutic quantity of a radiopharmaceutical without determining whether the exposure to any other individual would likely exceed 5 millisieverts (0.5 rem). This violation is classified as a Severity Level IV.
The NRC has concluded that information regarding the reasons for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed in our inspection report and in your letter dated October 29, 1999. 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, the enclosed Notice, and your response if you choose to respond, will be placed in the NRC Public Document Room.
||Original Signed By
||J. E. Dyer
Docket No. 030-02028
License No. 21-03210-01
Enclosure: Notice of Violation
NOTICE OF VIOLATION
|St. John Hospital and Medical Center
||Docket No. 030-02028
License No. 21-03210-01
During an NRC inspection conducted on October 19 through 23, 1999, 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:
||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 May 28, 1998, section (3.) "Verification of Radio-pharmaceutical Identity and Activity," requires that prior to issuance by the radiopharmacy, the identity and activity of each dose containing iodine-131 will be independently confirmed by two qualified individuals, one of whom is the person who will administer the dose. The procedure requires that all therapeutic doses will be independently evaluated by two qualified individuals to verify that the activity of the dose does not differ from the prescribed activity by more than ten percent.
Contrary to the above, two qualified individuals under the supervision of the licensee's authorized user did not verify that the activity of the dose administered did not differ from the prescribed activity. Specifically, on September 7, 1999, the activity of one dose containing 264 millicuries I-131 sodium iodide and another dose containing 296 millicuries were not independently evaluated by two qualified individuals to verify the activity of the doses were within ten percent of the written directive, resulting in a misadministration in one of the two cases. (01013)
|This is a Severity Level III violation (Supplement VI).
||10 CFR 35.75 (a) requires, in part, that the licensee may authorize the release from its control any individual who has been administered radiopharmaceuticals if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem).
Contrary to the above, on September 7, 1999, the licensee released from its control two individuals who had been administered radiopharmaceuticals and did not determine if the total effective dose equivalent to any other individual from exposure to the released individual was not likely to exceed 5 millisieverts (0.5 rem). Specifically, the licensee released from its control two patients who had been administered 265 millicuries, and 297 millicuries iodine-131 respectively, without determining if the exposure to any other individuals was not likely to exceed 5 millisieverts (0.5 rem). (02014)
|This is a Severity Level IV violation (Supplement VI).
The NRC has concluded that information regarding the reasons for the violations, and the corrective actions taken and planned to correct the violation and prevent recurrence is already adequately addressed in our inspection report and in a letter from St. John Hospital and Medical Center dated October 29, 1999. However, you are required to respond to the provisions of 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 III, 801 Warrenville Road, Lisle, Illinois 60532-4351, within 30 days of the date of the letter transmitting this Notice of Violation.
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, D.C. 20555-0001.
If you choose to respond your response will be placed in the NRC Public Document Room (PDR). Therefore, 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. Under the authority of Section 182 of Act 42 U.S.C. 2232, any response shall be submitted under oath or affirmation.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.
Dated this 20th day of December 1999.
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