United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-96-491 - St. Francis Hospital

May 14, 1997

EA 96-491

Mr. Roger Burgess
Chief Executive Officer
St. Francis Hospital
3401 Ludington Street
Escanaba, Michigan 49829


SUBJECT:  NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL
          PENALTY -   $2,500 
          (NRC INSPECTION REPORT NO. 030-11102/96001(DNMS) AND  INVESTIGATION
          REPORT NO. 3-96-039)

Dear Mr. Burgess:

This refers to the inspection conducted on July 15, 1996, with continuing NRC review through November 8, 1996, and the investigation conducted by the NRC Office of Investigations (OI) from July 29 through November 8, 1996, at St. Francis Hospital in Escanaba, Michigan. The inspection report and the synopsis of the OI findings were sent to you by letter dated January 3, 1997.

Based on the information developed during the inspection, investigation, and the information provided in your response to the inspection report received on February 24, 1997, 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 violation cited in Section I of the Notice, failure to maintain complete and accurate information required by the Commission, was deliberate. Specifically, an individual deliberately generated records that implied that the daily area radiation survey, the dose calibrator constancy check, and the molybdenum/technetium concentration measurement had been performed. According to statements made by the individual, he often found it expedient to fill out required daily records during slow times and then perform the actual tests or surveys later. Although this individual admitted knowledge of the proper sequence of the tests, he failed to fully understand the significance of the sequence in which the tests are required to be performed.

The violation in Section I of the Notice did not appear to adversely impact the health of patients. However, deliberate violations are of significant concern because the NRC's regulatory programs are based on licensees and their employees acting with integrity. St. Francis Hospital, 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. Because of the willful nature of the violation in Section I of the Notice, it has been categorized in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 at Severity Level III.

The violations cited in Section II of the Notice consist of: (1) failure to monitor for radioactive contamination of the external surface of a Yellow II package; (2) failure to perform a dose calibrator constancy check at the beginning of each day of use; (3) failure to determine the molybdenum/ technetium concentration prior to administering doses to patients; (4) failure to measure the radiation levels of a Yellow II package; and (5) failure to provide annual refresher training. One contributing factor to these violations, as well as the violation identified in Section I of the Notice, is the failure to provide the individual with sufficient instruction and oversight to ensure that the worker understood why certain tests should be performed prior to administering doses to patients.

Collectively, the violations in Section II of the Notice are of significant regulatory concern because they demonstrate training deficiencies and a lack of oversight of the licensed program by the radiation safety officer and management. Incumbent upon each NRC licensee is the responsibility to protect public health and safety by assuring that all NRC requirements are met. Therefore, these violations 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 violation or problem. Because the violation in Section I was 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 violation was discovered by the NRC during an inspection. In your

February 24, 1997 response to our letter dated January 3, 1997, you indicate that the corrective actions taken and/or planned to address this violation include: (1) hiring a certified nuclear medicine technologist; (2) increasing management supervision of licensed activities; (3) reviewing and improving the training program; and (4) using a third party consultation group to review procedures and policies and to provide annual refresher training for nuclear medicine staff. Based upon the above actions, credit for Corrective Action was warranted.

Therefore, to emphasize that willful violations of NRC requirements will not be tolerated and to ensure prompt identification of violations, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice at the base amount of $2,500 for the Severity Level III violation in Section I of the Notice.

As to the violations in Section II of the Notice, your facility has not been the subject of escalated enforcement actions within the last two inspections. Therefore, 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 was warranted based on your written response received by the NRC Region III office on February 24, 1997, addressing the subject inspection report. The actions taken include: (1) hiring an additional certified nuclear medicine technologist; (2) initiating a more comprehensive and interactive training program for new and temporary workers; (3) updating refresher training to include observations by the radiation safety officer and performance-based training methods; (4) acquiring assistance from an independent consultant to review the entire program; and (5) increasing management supervision. Consequently, no civil penalty is being proposed for these violations.

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. Issuance of the Notice constitutes escalated enforcement action that may subject you to increased inspection effort.

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, 

                             /s/ James L. Caldwell (for)

                             A. Bill Beach 
                             Regional Administrator 

Docket No. 030-20901
License No. 21-16481-01

Enclosure:
Notice of Violation and Proposed Imposition of Civil Penalty


NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY
St. Francis Hospital                                                  Docket No. 030-11102
Escanaba, Michigan                                                    License No. 21-16481-01
                                                                      EA 96-491 

During an NRC inspection on July 15, 1996, with continuing NRC review through November 8, 1996, and the investigation conducted by the NRC Office of Investigations from July 29, through November 8, 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. Violation Assessed a Civil Penalty

10 CFR 30.9(a) requires, in part, that information required by the Commission's regulations to be maintained by the licensee shall be complete and accurate in all material respects.

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 and that the check be done on a frequently used setting. 10 CFR 35.50(e) requires, in part, that a licensee retain a record of each check for three years unless otherwise directed.

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. 10 CFR 35.70(h) requires, in part, that a licensee retain each survey for three years.

10 CFR 35.204(b) states that a licensee that uses molybdenum-99/ technetium-99m generators for preparing a technetium-99m radiopharmaceutical shall measure the molybdenum-99 concentration in each eluate or extract. 10 CFR 35.204(c) requires, in part, that a licensee that must measure molybdenum concentration retain a record of each measurement for three years.

Contrary to the above, on July 15, 1996, information required by the Commission's regulations to be maintained by the licensee were not accurate in all material respects. Specifically, records of the dose calibrator check, the daily area survey, and molybdenum concentration were not accurate in that the results were recorded prior to the tests being performed. This is material to the NRC because, during an NRC inspection, the records could have influenced the NRC as to whether the checks have been performed. (01013)

This is a Severity Level III violation (Supplement VII).
Civil Penalty - $2,500

II. Violations Not Assessed a Civil Penalty

A. 10 CFR 20.1906(b) 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 unless the package contains only radioactive material in the form of a gas or in special form.

Contrary to the above, on July 15, 1996, the licensee received a package labeled with a Radioactive Yellow II label, the package was not exempt from the monitoring requirement for radioactive contamination, and the licensee did not perform the required monitoring. Specifically, the package received by the licensee contained a 1.5-curie molybdenum-99/technetium-99m generator. (02013)

B. 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 15, 1996, the licensee did not check the dose calibrator for constancy with a dedicated check source and the dose calibrator was used to measure patient doses of radiopharmaceuticals on that day. (02023)

C. 10 CFR 35.204(b) requires that a licensee that uses molybdenum-99/technetium-99m generators for preparing a technetium-99m radiopharmaceutical measure the molybdenum-99 concentration in each eluate or extract.

Contrary to the above, on July 15, 1996, the licensee used a molybdenum-99/technetium-99m generator to prepare technetium-99m radiopharmaceuticals and the licensee did not measure the molybdenum-99 concentration in the generator eluate. (02033)

D. Condition 13.A. of License No. 21-16481-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated March 30, 1995.

Item 10.7 of the referenced application requires that Appendix L, Regulatory Guide 10.8, Rev. 2 entitled "Model Procedures for Safely Opening Packages Containing Radioactive Material" will be followed. Item 2.c of Appendix L requires that the licensee measure the exposure rate at one meter and at the surface of the package.

Contrary to the above, on July 15, 1996, the licensee did not measure the exposure rate at the surface of a Yellow II package containing a 1.5-curie molybdenum-99/technetium-99m generator. (02043)

E. Condition 15.A. of License No. 21-16481-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated January 5, 1990.

Condition 13.A. of License No. 21-16481-01 requires that licensed material be possessed and used in accordance with statements, representations and procedures contained in an application dated March 30, 1995.

Item 8 of the referenced applications require that Appendix A, Regulatory Guide 10.8, Rev. 2 entitled "Personnel Training Program" will be followed. Appendix A states, in part, that occupational personnel will receive annual refresher training. This training is to include applicable regulations and license conditions.

Contrary to the above, between December 1994 and July 1996, a licensee employee who performed activities using licensed materials did not receive annual refresher training. (02053)

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

Pursuant to the provisions of 10 CFR 2.201, St. Francis Hospital (Licensee) 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 14th day of May 1997

 

 

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