EA-02-248 - St. Joseph Mercy Hospital

May 7, 2003

EA-02-248
NMED No. 020923

Julie MacDonald
Senior Vice President & Chief Operating Officer
St. Joseph Mercy Health System
St. Joseph Mercy Hospital
5301 East Huron River Drive
Ann Arbor, MI 48106-0995

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$6,000 (NRC SPECIAL INSPECTION REPORT NO. 030-01997/2002001(DNMS))

Dear Ms. MacDonald:

This refers to the special inspection conducted from October 4 through 16, 2002, at St. Joseph Mercy Hospital, Ann Arbor, Michigan, with continued in-office review through November 15, 2002. The purpose of the inspection was to review the circumstances, root and contributing causes, and proposed corrective actions regarding exposures to several members of the public in excess of the NRC's annual limit of 100 millirem. In addition, the inspection included a review of whether activities authorized by the license were conducted safely and in accordance with NRC requirements. The inspection report was issued on December 10, 2002, and documented several apparent violations of NRC requirements involving an overexposure to a member of the public.

On January 16, 2003, a predecisional enforcement conference was conducted in the Region III office with members of your staff to discuss the apparent violations, their significance, their root causes, and your corrective actions.

Based on the information developed during the inspection, information in your August 15, September 11, and October 1, 2002, reports on the incident, and the information that you 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 in Section I of the Notice involve: (1) the failure to conduct operations so that the total effective dose equivalent to individual members of the public from licensed operations does not exceed 0.1 rem in a year; and (2) the failure of the radiation safety officer to investigate overexposures and other deviations from approved radiation safety practice and implement corrective actions as necessary.

Specifically, for the period from July 1 through July 7, 2002, a member of the public received a total effective dose equivalent between 3 and 15 rem. The individual received the exposure while visiting a relative who had been administered a radiopharmaceutical therapy dosage of 285 millicuries of sodium iodide iodine-131. The individual received the exposure as a result of not following prescribed radiation safety instructions, including staying behind the shielding. Hospital staff frequently noted the individual sitting at the patient's bedside where a shield was not located. When this was observed, the hospital staff reminded the individual to position herself on the other side of the bed behind shielding. While the member of the public disregarded radiation safety instructions provided by hospital staff, the radiation safety officer failed to implement corrective actions as necessary to minimize the individual's exposure, once the extent of the potential exposure was identified.

During the predecisional enforcement conference, you stated that you did not take more proactive steps to limit the dose to visitors or to contact the patient's relatives to more accurately determine their dose because of your concern for the patient's rights and for compassion toward the patient and family members. The NRC staff understands that the case involved unusual circumstances and that you did not want to appear uncompassionate toward the patient or her family. However, you could easily have implemented a number of actions in response to the daughter not following instructions, such as: (1) explaining to the daughter that staying an arm's length from the patient would significantly reduce the exposure (radiation levels at one meter were approximately one-tenth those at the bedside); (2) using additional shielding, including shielding the catheter bag; (3) minimizing the daughter's time at the bedside; and (4) providing a digital dosimeter for the daughter to self-monitor her exposure, which you had available. Therefore, the NRC has determined that your staff's performance was deficient such that enforcement action is warranted.

Although the NRC's medical consultant indicated that the radiation exposure received by this individual is not significant from a health and safety standpoint, the NRC considers any exposure in excess of regulatory limits a significant matter. The NRC expects licensees to conduct their operations in a manner that precludes such exposures from exceeding the limits established in 10 CFR Part 20. In this case, the exposure to the individual was well in excess of the regulatory limit. Therefore, these violations are categorized collectively in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a Severity Level I problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $6,000 is considered for a Severity Level I problem. The NRC considered whether credit was warranted for Identification and Corrective Action in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. Credit for identification is not warranted. While your staff identified that an overexposure to a member of the public occurred, there were missed opportunities during the patient's treatment to identify the potential for the overexposure and take prompt actions to prevent the overexposure or significantly reduce the dose to the individual. These opportunities occurred when your radiation safety officer realized that the exposed individual was not following hospital instructions and did not take immediate actions to appropriately manage the situation. Credit for your corrective action is warranted. Your corrective actions included: (1) suspending administration of sodium iodide iodine-131 therapy dosages to patients; (2) revising visitation rules and requirements; (3) instituting organizational and reporting changes; (4) enhancing the education program for therapy patient visitors regarding the safety and risks associated with therapy treatments; (5) revising documentation of visitor stay times; (6) enhancing the monitoring of visitors' adherence to safety instructions and proximity to the therapy patient; and (7) revising staff training to include identification and reporting of incidents and steps to be taken when visitors do not follow safety instructions.

Therefore, to emphasize the need to limit the dose to members of the public visiting your facility and the prompt identification and initiation of corrective actions, I have been authorized, after consultation with the Director, Office of Enforcement, and the Commission, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $6,000 for the Severity Level I problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased NRC inspection effort.

The violations in Section II of the Notice involve the failure to: (1) promptly measure the dose rate in contiguous areas surrounding the room of a patient who was administered a radiopharmaceutical therapy dosage; (2) conduct operations such that the dose rate in unrestricted areas does not exceed 0.002 rem in any one hour; and (3) submit an estimate of the exposed individual's dose with the required 30-day written report. These violations are each separately categorized in accordance with the Enforcement Policy at Severity Level IV. Civil penalties are not assessed for Severity Level IV violations.

Concerning the apparent violation described in our inspection report involving the failure to use procedures and engineering controls to achieve doses to members of the public as low as is reasonably achievable, the NRC has evaluated the information discussed in your January 15, 2003, letter and presented at the conference, and has concluded that a violation of NRC requirements did not occur.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in Inspection Report No. 030-01997/2002001(DNMS) and your January 15, 2003 letter. Therefore, you are not required to respond, as provided by 10 CFR 2.201, 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, its enclosures, and your response, if any, will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. The NRC also includes Issued Significant Enforcement Actions on its Web site.

		Sincerely,
		/RA/ James L. Caldwell for
		J. E. Dyer Regional Administrator

Docket No. 030-01997
License No. 21-00943-03

Enclosures:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. NUREG/BR-0254 Payment Methods (Licensee only)

cc: State of Michigan

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

St. Joseph Mercy Hospital Ann Arbor, Michigan

Docket No. 030-01997 License No. 21-00943-03 EA-02-248

During an NRC inspection conducted from October 4 through November 15, 2002, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the NRC proposes to impose a civil penalty pursuant to Section 234 of the Atomic Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205. The particular violations and associated civil penalty are set forth below:

1.	Violations Assessed a Civil Penalty
	A.	10 CFR 20.1301(a) requires that each licensee conduct operations so that the total effective dose equivalent to individual members of the public from licensed operations does not exceed 100 millirem in a year. Contrary to the above, from July 1 through July 7, 2002, the licensee conducted operations such that the total effective dose equivalent to individual members of the public exceeded 100 millirem in a year. Specifically, a member of the public received a total effective dose equivalent of between 3 and 15 rem from exposure to a patient who had received radioactive material from licensed operations and was hospitalized for compliance with 10 CFR 35.75.
	B.	10 CFR 35.21(b)(1) requires, in part, that the Radiation Safety Officer investigate overexposures and other deviations from approved radiation safety practice and implement corrective actions as necessary. Contrary to the above, between July 1 and 7, 2002, the Radiation Safety Officer did not investigate overexposures and other deviations from approved radiation safety practice or implement corrective actions as necessary. Specifically, during a patient treatment that included the administration of 285 millicuries of sodium iodide iodine-131, the licensee's Radiation Safety Officer failed to investigate and implement corrective actions when it became known that a relative of the patient was not following the licensee's approved radiation safety practices and may have received an overexposure.
This is a Severity Level I problem (Supplement IV and VI). Civil Penalty - $6000
II.	Violations Not Assessed a Civil Penalty
	A.	10 CFR 35.315(a)(4) requires, in part, that for each patient receiving radiopharmaceutical therapy and hospitalized for compliance with 10 CFR 35.75, a licensee promptly after administration of the dosage, measure the dose rates in contiguous restricted and unrestricted areas with a radiation measurement survey instrument to demonstrate compliance with the requirements of 10 CFR Part 20. Contrary to the above, on July 1, 2002, the licensee administered to a patient 285 millicuries of sodium iodide iodine-131 for radiopharmaceutical therapy, a dosage for this patient which required hospitalization for compliance with 10 CFR 35.75, and the licensee did not measure the dose rates in contiguous restricted and unrestricted areas.
		This is a Severity Level IV violation (Supplement VI)
	B.	10 CFR 20.1301(a)(2) requires that each licensee conduct operations so that the dose in any unrestricted area from external sources, with exceptions not applicable here, does not exceed 2 millirem in any one hour. Contrary to the above, the licensee conducted operations so that the dose in unrestricted areas exceeded 2 millirem in any one hour. Specifically, licensee operations on July 1, 2002, resulted in a dose of 10 millirem in one hour in an emergency exit stairway, and a dose of 17millirem in one hour outside the ground floor window of a patient's room. Licensee operations continued through July 7, 2002, when the resultant doses were 4 millirem in one hour and 8 millirem in one hour, respectively. This is a Severity Level IV violation (Supplement IV)
	C.	10 CFR 20.2203 requires that each licensee submit a written report within 30 days after learning of a dose in excess of the limits for an individual member of the public. The report must include estimates of each individual's dose. Contrary to the above, the licensee's August 15, 2002 report of a dose in excess of the limits in 10 CFR 20.1301 for an individual member of the public did not include an estimate of the individual's dose. This is a Severity Level IV violation (Supplement IV)

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance will be achieved, is already adequately addressed on the docket in Inspection Report No. 030-01997/2002001(DNMS) and your January 15, 2003 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, EA-02-248" 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 III, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

Within the same time as provided for the response required above under 10 CFR 2.201, the licensee may pay the civil penalty proposed above or the cumulative amount of the civil penalties if more than one civil penalty is proposed, in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission. Should the licensee fail to answer within the time specified, an order imposing the civil penalty will be issued. Should the licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalty, in whole or in part, such answer should be clearly marked as an "Answer to a Notice of Violation" and may: (1) deny the violations listed in this Notice, in whole or in part, (2) demonstrate extenuating circumstances, (3) show error in this Notice, or (4) show other reasons why the penalty should not be imposed. In addition to protesting the civil penalty, in whole or in part, such answer may request remission or mitigation of the penalty.

In requesting mitigation of the proposed penalty, the factors addressed in Section VI.C.2 of the Enforcement Policy should be addressed. Any written answer in accordance with 10 CFR 2.205 should be set forth separately from the statement or explanation in reply pursuant to 10 CFR 2.201, but may incorporate parts of the 10 CFR 2.201 reply by specific reference (e.g., citing page and paragraph numbers) to avoid repetition. The attention of the licensee is directed to the other provisions of 10 CFR 2.205, regarding the procedure for imposing a civil penalty.

Upon failure to pay any civil penalty due which subsequently has been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalty, unless compromised, remitted, or mitigated, may be collected by civil action pursuant to Section 234(c) of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: Frank Congel, Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, One White Flint North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy to the Regional Administrator, U.S. Nuclear Regulatory Commission, Region III, Suite 255, 801 Warrenville Road, Lisle, IL 60532-4351.

Your response will be made available electronically for public inspection in the NRC Public Document Room or from the 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 7^th day of May 2003.