EA-97-234 - St. Mary's Hospital of Blue Springs

July 23, 1997

EA 97-234

Ms. Michele M. Schaefer
Chief Operating Officer
St. Mary's Hospital of Blue Springs
201 West R. D. Mize Road
Blue Springs, MO 64015

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $2,500 (NRC Inspection Report No. 030-18183/96001(DNMS))

Dear Ms. Schaefer:

This refers to the inspection conducted on September 25, 1996, with continuing NRC review through November 13, 1996, at St. Mary's Hospital of Blue Springs (SMH), Blue Springs, Missouri. The purpose of the inspection was to determine whether activities authorized by the license were conducted safely and in accordance with NRC requirements. The inspection report was sent to you by letter dated December 6, 1996. A transcribed predecisional enforcement conference was held in the NRC Region III office on May 22, 1997, with you and other members of the SMH staff to discuss the violations, their causes, and proposed corrective actions.

Based on the information developed during the inspection and the information provided during the conference, the NRC has determined that violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) and the circumstances surrounding them are described in detail in the subject inspection report.

The NRC has concluded that the violations cited in Section I of the Notice, including the failure to perform constancy tests, the failure to perform area surveys, the failure to perform direct radiation surveys of packages, and the failure to monitor packages for external contamination, occurred as the result of careless disregard for NRC requirements. Specifically, the nuclear medicine technologist failed to perform tests and procedures required by SMH's license through complacency, rather than through mistake or error. In this case, the technologist was knowledgeable of the requirements and knew how to perform the tests, but failed as a result of complacency to fulfill the requirements, particularly when working on the weekends.

The violations in Section I of the Notice did not appear to adversely impact the health of patients. However, by failing to perform required tests and calibrations, you were deprived of important information such as knowing whether the dose calibrator was functioning properly and whether packages or work areas were contaminated with radioactive material. Violations involving careless disregard are considered willful and are of significant concern because the NRC's regulatory programs are based on licensees and their employees acting with integrity. SMH, as an entity licensed to possess and use radioactive material, is responsible for the acts of its employees. It is essential that the NRC be able to maintain the highest trust in individuals working with licensed material and that licensees appropriately manage their programs to ensure that personnel fully understand the importance of complying with regulatory requirements. Therefore, because of the willful nature of the violations in Section I of the Notice, they have been classified in the aggregate in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level III problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,500 is considered for a Severity Level III problem. Because the violations in Section I were willful, 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. No credit was warranted for Identification because the violations were discovered by the NRC during an inspection. In a letter dated October 2, 1996, and at the predecisional enforcement conference held on May 22, 1997, your staff outlined corrective actions planned and/or taken which included: (a) monthly review of the technologists work by the radiation safety officer; (b) discussion of the inspection findings and licensed procedures to be followed on the weekends with the appropriate personnel; (c) institution of a policy of disciplinary action and (d) a doubling of the hours spent by the radiation safety officer attending to program activities. Based on the above actions, credit for Corrective Action was warranted.

Therefore, to emphasize that licensees must maintain control over licensed activities, especially on weekends when there may be less management presence, and the importance of avoiding complacency, and to ensure prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice in the base amount of $2,500 for the Severity Level III problem in Section I of the Notice. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

A letter also is being sent directly to the technologist concerning the violations in Section I of the Notice. You will receive a copy of this correspondence under separate cover.

The violations in Section II of the Notice involving the failure to perform accuracy and geometry dependence tests on the dose calibrator following installation, the failure to process personnel monitoring devices in a timely manner, the failure to maintain records of radiation safety committee meetings, the failure of the radiation safety officer to attend a radiation safety committee meeting, and the failure to conduct two radiation safety committee meetings in 1995, have been categorized as Severity Level IV violations in accordance with the Enforcement Policy. While these violations did not impact safety of the public, the patients, or your staff, they are indicative of a need for strengthening the oversight and control of the radiation safety program. Please include with your response to the Notice SMH's plan to improve the oversight and control of the licensed program and to ensure that program issues are identified, evaluated and resolved.

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 (PDR).

Sincerely,

A. Bill Beach Regional Administrator

Docket No. 030-18183
License No. 24-20274-01

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

St. Mary's Hospital of Blue Springs Blue Springs, MO

Docket No. 030-18183 License No. 24-20274-01 EA 97-234

During an NRC inspection conducted on September 25, 1996, with continuing NRC review through November 13, 1996, 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:

I. Violations Assessed a Civil Penalty

A. 10 CFR 35.50(b)(1) requires, in part, that a licensee check each dose calibrator for constancy with a dedicated check source at the beginning of each day of use.

Contrary to the above, on July 6, 1996, August 3, 1996, and September 15, 1996, the licensee did not check the dose calibrator for constancy with a dedicated check source at the beginning of each day of use.

B. 10 CFR 35.70(a) requires that a licensee survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.

Contrary to the above, on numerous weekends between July 6, 1996 and September 26, 1996, the licensee did not survey with a radiation detection instrument at the end of the day areas where radiopharmaceuticals were routinely prepared for use or administered.

C. 10 CFR 20.1906(b)(1) requires, in part, that each licensee monitor the external surfaces of a package labeled with a Radioactive White I, Yellow II, or Yellow III label for radioactive contamination.

Contrary to the above, on July 6, 1996, August 3, 1996, and September 15, 1996, the licensee received Radioactive White I labeled packages and did not monitor the external surfaces for radioactive contamination.

D. Condition 16 of License No. 24-20274-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated May 13, 1993.

Item 10.7, paragraphs 2.c and 2.d, of the referenced application, entitled, "Procedures For Safely Opening Packages Containing Radioactive Material", requires all packages to be measured (for radiation) at three feet and at the surface.

Contrary to the above, on July 6, 1996, August 3, 1996, and September 15, 1996, the licensee did not measure (for radiation) each package at three feet and at the surface.

These violations represent a Severity Level III problem (Supplements VI & IV)
Civil Penalty - $2,500.

II. Violations Not Assessed A Civil Penalty

Condition 16 of License No. 24-20274-01 requires, in part, that the licensee conduct its program in accordance with the statements, representations, and procedures contained in the application dated May 13, 1993.

A. Item 9.4, paragraphs 2 and 3 of the referenced application entitled, Personnel External Exposure Monitoring Program, states, in part, film or thermoluminescent dosimeter (TLD) whole body monitor and film or TLD finger monitors issued to individuals will be processed by a contract service on a monthly basis.

Contrary to the above, two personnel monitors used for the periods of November 1995 and February 1996 were not processed until May 1996 and two personnel monitors used for the months of April 1995 and May 1995 were not processed until September 1995, periods which exceed one month.

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

B. Item 10.1A, paragraph 8 of the referenced application, entitled, Medical Isotopes Committee, requires that the Radiation Safety Committee (RSC) maintain written records of all committee meetings, actions, recommendations, and decisions.

Contrary to the above, there were no written records of the RSC meeting held on June 6, 1996.

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

C. 10 CFR 35.50(b)(2) and (4) require in part that, upon installation, a licensee test each dose calibrator for accuracy, and for geometry dependence over the range of volumes and volume configurations for which it will be used.

Contrary to the above, the licensee did not test the dose calibrator for geometry dependence or accuracy at the time of installation which occurred on December 13, 1995.

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

D. 10 CFR 35.22(a)(2) requires that the Radiation Safety Committee meet at least quarterly.

Contrary to the above, the licensee's Radiation Safety Committee did not meet between February 1995 and November 1995, a period in excess of a calendar quarter.

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

E. 10 CFR 35.22(a)(3) requires that to establish a quorum and conduct business, at least one half of the Radiation Safety Committee's membership must be present, including the Radiation Safety Officer and the management's representative.

Contrary to the above, on March 26, 1996, the licensee's Radiation Safety Committee met and conducted business and the Radiation Safety Officer was not present.

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

Pursuant to the provisions of 10 CFR 2.201, St. Mary's Hospital of Blue Springs 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" 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. 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. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

Within the same time as provided for the response required above under 10 CFR 2.201, the Licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, 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.B.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, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, 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.

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.

Dated at Lisle, Illinois
this 23rd day of July 1997