United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-99-215 - MidMichigan Medical Center

November 26, 1999

EA 99-215

David Reece, Administrator/CEO
MidMichigan Medical Center
4005 Orchard DriveMidland, MI 48670

SUBJECT: NOTICE OF VIOLATION
(NRC Inspection Report 030-02013/99001(DNMS) and
Office of Investigation Report 3-1999-019)

Dear Mr. Reece:

This refers to the inspection conducted June 7 through 17, 1999, and the investigation completed by the Office of Investigations (OI) on August 23, 1999, at MidMichigan Medical Center (MMC or Licensee) in Midland, Michigan. The inspection was conducted to review the circumstances concerning a reported iodine-131 misadministration and a report documenting the inspection was issued by our letter dated July 2, 1999. The OI investigation was conducted to determine if apparent violations identified during the inspection were deliberate. Summaries of the OI findings and of the apparent violations identified were transmitted to you by letter dated September 7, 1999. A closed, transcribed predecisional enforcement conference was conducted on September 17, 1999, in the Region III office to discuss the apparent violations, their root causes, and your corrective actions taken or planned.

Based on the information developed during the inspection, the investigation, and the information that was provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involve failures to: (1) consult a written directive before administering a therapeutic quantity of iodine-131 to a patient, (2) report a misadministration in a timely manner, and (3) provide the NRC inspector with complete and accurate information.

A misadministration occurred when a patient received approximately 100 millicuries of iodine-131 on May 24, 1999, instead of 150 millicuries as prescribed. The root causes of the misadministration consist of: 1) one individual ordered the incorrect amount of iodine; and 2) a second individual failed to review the written directive as required by MMC's quality management program before administering the dosage. The administering individual identified the inconsistency shortly after dosing the patient, but did not alert the physician or management. Two days later, the prescribing physician not only discovered that a misadministration had occurred, but also determined that the written directive had been altered to reflect the actual dose administered. Your staff reported the misadministration to the NRC on June 1, 1999. Based on all available information, the NRC concluded that an MMC employee engaged in deliberate misconduct by willfully failing to consult the physician's written directive prior to administering a therapeutic dosage to a patient, altering the written directive and providing incomplete and inaccurate information to the NRC inspector, and that his actions, in part, caused MMC to file an untimely report. It is essential that the NRC be able to maintain the highest trust and confidence that licensees and their employees will act with integrity and abide by the requirements designed to ensure that doses prescribed are delivered. The use of therapeutic quantities of radioactive material requires rigor on the part of all involved in its administration. Under these circumstance, the patient could have received a substantial overdose of iodine-131, because the safeguards in place in your medical quality management program were not followed. Because these violations involve willfulness, they are classified in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

During the predecisional enforcement conference, you disagreed with the OI synopsis in that you do not feel that your technologist willfully administered the incorrect dosage. Within the context of the NRC enforcement policy, "willfulness" encompasses both deliberate violations and violations involving careless disregard. Careless disregard connotes conduct which demonstrates reckless disregard or reckless indifference as to whether a requirement will be violated. In this case, we agree that the individual did not deliberately administer the wrong dose. However, we found the individual to have displayed careless disregard when he failed to verify the dose to be administered against the written directive. His failure to verify was more than just the result of negligence or oversight. Therefore, the NRC concluded that his actions constituted careless disregard and as such were considered willful.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III problem. Because the violations described in the enclosed Notice are willful violations, 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. Since your staff identified the violations and exercised considerable effort to determine the root cause, credit for identification is warranted. The NRC has also determined that credit is warranted for corrective actions taken and/or planned. The actions include: (1) a memo sent to all nuclear medicine physicians and staff which covered the following topics: (A) a reminder to review the written directive prior to administration; (B) definition of a misadministration, and (C) an explanation of reporting procedures; (2) combining the written directive and ordering documentation into a single form for clarity; and (3) suspension of the individual involved and removing him from a supervisory position.

In addition to the corrective actions stated above, it is our understanding, based on an October 5, 1999 telephone conversation between Mr. Ohle, MMC Vice President and Mr. D. Wiedeman of the Region III staff, that for the next 24 months additional oversight of the individual will be performed. This oversight will include: (1) supervision by another technologist or the physician whenever he administers therapy dosages; (2) all daily NRC regulated activities conducted by this individual, such as dose calibrator constancy, wipe tests, surveys, etc., will be double checked by another technologist; and (3) the radiation safety officer or his assistant will conduct weekly reviews of the work performed by the individual in question and provide periodic reports of his performance to MMC administration. If our understanding is in error, please contact Mr. G. Wright immediately at (630) 829-9602.

To encourage prompt identification and comprehensive correction of violations, a civil penalty in this case is not being proposed. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action that may subject you to increased inspection effort.

The NRC is corresponding separately with the individual involved with this matter. You will receive a copy of that correspondence under separate cover.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

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

Sincerely,

R. W. Borchardt, Director
Office of Enforcement

Docket No. 030-02013
License No. 21-01549-02

Enclosure: Notice of Violation

cc w/encl: Larry Langrill, Ph.D., RSO



NOTICE OF VIOLATION

MidMichigan Medical Center
Midland, Michigan
      Docket No. 030-02013
License No. 21-01549-02
EA 99-215

During an NRC inspection and investigation completed on June 17, 1999, and August 23, 1999, respectively, 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 35.25(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 January 20, 1992, in Item 3 under RADIOPHARMACEUTICAL USES, requires that the radiopharmaceutical, the dosage, and the route of administration to be verified, with the script in hand, prior to dose administration.

Contrary to the above, on May 24, 1999, a nuclear medicine technologist, an individual under the supervision of the licensee's authorized user, did not follow the written quality management procedures established by the licensee in that he did not verify that the administered dosage was in accordance with the prescribed dosage. (01013)

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 a misadministration. 10 CFR 35.2 defines in part, "misadministration" to mean the administered dosage differs from the prescribed dosage by more than 20 percent of the prescribed dosage.

Contrary to the above, on May 26, 1999, the licensee discovered that a misadministration occurred and the licensee did not notify the NRC until June 1, 1999, which was later than the next calendar day. The misadministration involved administration of a dosage of iodine-131 that differed by approximately 33 percent from the prescribed dosage. (01023)

C.   10 CFR 30.9(a) requires, in part, that information provided to the Commission by a licensee be complete and accurate in all material respects.

Contrary to the above, on June 7 and 8, 1999, a licensee representative (nuclear medicine technologist) did not provide to the Commission information that was complete and accurate in all material respects. Specifically, the nuclear medicine technologist stated to the NRC inspector that he did not know who changed the physician's written directive or why it had been changed without the physician's approval. This technologist subsequently acknowledged that he modified the written directive without the physician's approval. This information was material because a misadministration is an event required to be reported to the NRC and a written directive is an NRC required record. (01033)

These violations represent a Severity Level III problem (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, MidMichigan Medical Center is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, DC 20555, with a copy to the Regional Administrator, Region III, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level; (2) the corrective steps that have been taken and the results achieved; (3) the corrective steps that will be taken to avoid further violations; and (4) the date when full compliance will be achieved. Your response may reference or include previous docketed correspondence, if the correspondence adequately addresses the required response. If an adequate reply is not received within the time specified in this Notice, an order or a Demand for Information may be issued as to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

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.

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. If personal privacy or proprietary information is necessary to provide an acceptable response, then please provide a bracketed copy of your response that identifies the information that should be protected and a redacted copy of your response that deletes such information. If you request withholding of such material, you must specifically identify the portions of your response that you seek to have withheld and provide in detail the bases for your claim of withholding (e.g., explain why the disclosure of information will create an unwarranted invasion of personal privacy or provide the information required by 10 CFR 2.790(b) to support a request for withholding confidential commercial or financial information). If safeguards information is necessary to provide an acceptable response, please provide the level of protection described in 10 CFR 73.21.

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

Dated this 26th day of November 1999

 

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