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EA-03-088 - Howard University Hospital

June 27, 2003

EA 03-088

Celia J. Maxwell, M.D.
Assistant Vice-Provoste for Health Affairs
Howard University Hospital
2041 Georgia Avenue, N.W.
Washington, DC 20060

SUBJECT: NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY – $3,000
(NRC Inspection Report No. 030-01321/2003-001)

Dear Dr. Maxwell:

This refers to the NRC inspection conducted on March 18 -19 and April 10, 2003, at your facility in Washington, D.C., to review activities authorized under the NRC license. As described in the NRC inspection report sent to you on May 16, 2003, one apparent violation of NRC requirements was identified during the inspection. The apparent violation involved inadequate radiological surveys of your facility and personnel. This apparent violation was associated with a personnel contamination which created a substantial potential for exposure in excess of the regulatory limits to the hands of one of your Nuclear Medicine Technologists (NMTs).

In your written report sent to the NRC on April 23, 2003, you stated that Howard University staff had performed calculations of the shallow dose exposure to the hands of the NMT who was contaminated during activities which occurred between March 18 and March 19, 2003. Since you were unable to ascertain exactly when the contamination events that contributed to the exposure occurred, nor the length of time it took to identify and decontaminate the NMT, you calculated dose calculations for three different scenarios. These scenarios consisted of: (1) a personnel contamination event identified on March 19 wherein the NMT was subsequently decontaminated at an indeterminate time later on that day; (2) two separate contamination events occurred on March 18 and March 19, that were discovered at the end of the work shift on each day, at which time the NMT was decontaminated; and (3) two separate contamination events occurred on March 18 and March 19, that were discovered after the work shift had ended on each day, at which time the NMT was decontaminated. The results of the calculations based on the three scenarios indicated a shallow (skin) dose exposure to the NMT's hands ranging from 9 to 19.5 Rem; the regulatory limit for this type of exposure is 50 rem.

In the letter transmitting the inspection report, we provided you the opportunity to address the apparent violation identified in the report by attending a predecisional enforcement conference before we made our final enforcement decision. On June 4, 2003, the apparent violation was discussed with you during a predecisional enforcement conference. The discussion included the violation, its causes, and your corrective actions. At the conference, you acknowledged that the violation had occurred and stated that the violation was caused by NMTs who had not followed your procedures. You also sent a letter to the NRC, dated June 6, 2003, that described your root cause analysis and further corrective actions that you have taken, or plan to take, to prevent recurrence of the violation.

Based on the information developed during the inspection, and the information provided in your response, the NRC has determined that one violation of NRC requirements occurred. The violation is cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding it are described in detail in the subject inspection report. The violation included the failure of NMTs to perform adequate area surveys within your facility that resulted in a substantial potential for exposures in excess of the regulatory limits. In addition, at least one NMT also failed to perform an adequate personnel survey and did not immediately identify contamination on his hand.

This violation is of concern to the NRC because the failure to conduct appropriate surveys of radioactive material resulted in a missed opportunity to identify contamination in your facilities and of one of your employees. If undetected, this contamination could have resulted in substantial unintended radiation dose to an individual. Therefore, this violation is categorized at a 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 current version of the Enforcement Policy, a base civil penalty in the amount of $3,000 is considered for a Severity Level III violation or problem. In making the actual determination for the appropriate amount of the civil penalty, the NRC also considered: (1) whether your facility has been the subject of an escalated enforcement action within the last two years or two inspections; (2) who identified the violation; and (3) the promptness and effectiveness of your corrective actions. This evaluation was in accordance with the civil penalty assessment process in Section VI.C.2 of the Enforcement Policy. In this case, your facility has been the subject of an escalated enforcement action within the last two years or two inspections(1). Therefore, the NRC evaluated whether credit was warranted for Identification and Corrective Action. Credit for identification is not warranted because the contamination was identified by the NRC during the inspection. Credit for corrective actions is warranted because your corrective actions as described in your letter dated April 23, 2003, and as discussed at the predecisional enforcement conference, were considered prompt and comprehensive. These corrective actions included, but were not limited to: (1) obtaining appropriate equipment and supplies for technologists, including new survey equipment and large size gloves for individuals with larger hands to prevent ripping and tearing of the gloves; (2) informing nurses about proper disposal of potentially contaminated items; (3) training NMTs on the correct methods for radiological area and personnel surveys; (4) performing confirmatory surveys by the Radiation Safety staff in the Nuclear Medicine area; (5) preparing a policy regarding disciplinary action for employees who do not follow procedures; and (6) increasing management and supervisory oversight of NMTs during the performance of licensed activities.

Accordingly, application of the normal civil penalty assessment process would result in a civil penalty in the base amount. Therefore, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $3,000 for the Severity Level III violation. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In your response, you may reference any previous correspondence that is applicable to this case to avoid repetitive submissions. The NRC will use your response, in part, to determine whether further enforcement action is necessary to ensure compliance with regulatory requirements.

Questions concerning this Notice may be addressed to Pamela Henderson of my staff. Ms. Henderson can be reached at telephone number (610) 337-6952.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and 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. The NRC also includes Issued Significant Enforcement Actions on its Web site.

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

Docket No. 030-01321
License No. 08-03075-07

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

cc w/encl:
District of Columbia
Dr. Marlene McKetty, Howard University
Dr. Thomas Gaiter, Howard University
Dr. Miles McCord, Howard University
Benjamin Wilson, Beveridge & Diamond, P.C.

ENCLOSURE

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

Howard University Hospital
Washington, DC		 License No. 08-03075-07
Docket No. 030-01321
EA 03-088

During an NRC inspection conducted on March 18 -19 and April 10, 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 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 violation and associated civil penalty are set forth below:

10 CFR 20.1501(a)(1) requires that each licensee make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20 and that are reasonable under the circumstances to evaluate the extent of radiation levels, concentrations or quantities of radioactive materials, and the potential radiological hazards that could be present.

Pursuant to 10 CFR 20.1003, survey means an evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, or presence of radioactive material or other sources of radiation.

Contrary to the above, prior to March 19, 2003, the licensee did not make adequate surveys to assure compliance with 10 CFR 20.1201(a)(2)(ii), which limits radiation exposure to the skin or extremities. Specifically,

  a. surveys performed by a Nuclear Medicine Technologist in the Nuclear Medicine Department on March 18, 2003, did not identify four areas contaminated with byproduct material (technicum-99m) exhibiting radiation dose rate levels of between 3 and 20 millirem per hour; and
b. during work performed by a Nuclear Medicine Technologist with licensed material on March 18, 2003, the Nuclear Medicine Technologist did not survey his extremities (hands) after handling byproduct material (technicum-99m) with damaged gloves (protective clothing).

This is a Severity Level III violation (Supplement IV).
Civil Penalty – $3,000

Pursuant to the provisions of 10 CFR 2.201, Howard University Hospital is hereby required to submit a written statement or explanation to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, within 30 days of the date of this Notice of Violation and Proposed Imposition of Civil Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation, EA 03-088" and should include for each alleged violation: (1) admission or denial of the alleged violation; (2) the reasons for the violation if admitted, and if denied, the reasons why; (3) the corrective steps that have been taken and the results achieved; (4) the corrective steps that will be taken to avoid further violations; and (5) 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 why the license should not be modified, suspended, or revoked or why such other action as may be proper should not be taken. Consideration may be given to extending the response time for good cause shown.

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, 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 30 days of the date of this Notice, 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, EA 03-088" 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 234c 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: F. 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 I.

Because 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), to the extent possible, it should not include any personal privacy or proprietary information so that it can be made available to the public without redaction. ADAMS is accessible from the NRC Web site at the Public NRC Library. 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).

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

Dated this 27th day of June 2003

1 Severity Level III Notice of Violation and Proposed Imposition of Civil Penalty ($3,000) issued to Howard University on June 21, 2002, for the failure to control radioactive material that resulted in the loss of a licensed quantity of source material (EA 02-102)

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Page Last Reviewed/Updated Tuesday, March 09, 2021