EA-97-066 - St. Joseph's Hospital and Medical Center

March 25, 1997

EA 97-066

Mr. Melvyn Patashnick
Vice President Clinical Services
St. Joseph's Hospital and Medical Center
703 Main Street
Paterson, New Jersey 07503

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY - $2,750 (NRC Inspection Report No. 030-02526/97-001)

Dear Mr. Patashnick:

This refers to the NRC inspection conducted on January 13 to 15, and January 30, 1997, at your Paterson, New Jersey facility to determine whether activities authorized by your NRC license were conducted safely and in accordance with requirements. At the conclusion of the inspection, the findings were discussed with you and the members of your staff identified in the Inspection Report. During the inspection, the inspector identified nine apparent violations of NRC requirements, as described in the NRC inspection report transmitted with our letter, dated February 24, 1997. On March 12, 1997, a predecisional enforcement conference was conducted with you and members of your staff to discuss the violations, their causes, and your corrective actions. A copy of the enforcement conference report will be forwarded to you by separate correspondence.

Based on the information developed during the inspection, information provided in your letter dated February 18, 1997, in response to a Confirmatory Action Letter issued by the NRC on February 14, 1997, as well as information provided during the enforcement conference, the NRC has determined that six violations of NRC requirements occurred. Three of the apparent violations, previously discussed in NRC inspection report No. 030-02526/97-001, have been determined not to be violations, based on information you provided the NRC during the conference, and will be described in the enforcement conference report.

The six violations that are being cited are described 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 violations involve: failure to provide, through the Radiation Safety Officer (RSO), the required oversight of the radiation safety program; failure to conduct required weekly surveys of the waste storage area; failure to perform the required iodine-131 air concentration surveys of the therapy suite; failure to monitor the iodine-131 air concentration in the waste storage area; failure of the RSO to sign records of the leakage tests; and failure of the RSO to sign records of the quarterly inventories of sealed sources.

These violations indicate a significant lack of attention by the RSO and the Radiation Safety Committee (RSC) to licensed activities. In fact, the majority of the violations that occurred were the direct responsibility of the RSO. Management attention to the radiation safety program is warranted to ensure that licensed activities are conducted safely and in accordance with requirements. While the violations in question did not have an impact on the health and safety of the public, patients, or your staff, such violations are potential precursors to more serious problems, and therefore, it is important that the RSO and the Radiation Safety Committee actively look for, identify, and correct such problems. This did not occur at your facility. Therefore, these violations have been classified in the aggregate as a Severity level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, at Severity Level III.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, 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. These actions, which were described either during the enforcement conference and/or in your February 18, 1997 response to an NRC Confirmatory Action Letter, included: (1) conduct of an internal audit of your monoclonal antibody program by Dr. F. Yuppa, Chairman of your Radiology Department, and his staff, and discussion of the audit findings with the RSC; (2) commitments at the enforcement conference to do additional audits of the monoclonal program; (3) retention of an outside contractor to perform an audit of your entire radiation safety program which was performed on February 28, 1997. However, credit for corrective actions is not warranted because your corrective actions, at the time of the enforcement conference, were not considered sufficiently prompt and comprehensive to warrant such credit. For example, although your outside consultant had completed an audit of the program on February 28, 1997, you indicated, at the time of the conference on March 12, 1997, that you were unaware of what the findings were.

Therefore, to encourage appropriate attention to your licensed program, as well as prompt and comprehensive correction of violations, I have been authorized to propose a civil penalty in the amount of $2,750 for the violations described in the enclosed Notice.

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, as appropriate, your response to the CAL. In addition, the inspection report raised a concern regarding the adequacy of thyroid bio-assays of personnel after administration of iodine-131. Specifically, such tests were performed in a manner that the tests would not adequately provide a quantitative assessment of iodine-131 intakes by personnel. Therefore, in your response, you should address changes in your bioassay procedures to ensure that a quantitative assessment of personnel thyroid uptakes and iodine-131 intake by personnel are adequately performed. 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,

ORIGINAL SIGNED BY WILLIAM L. AXELSON FOR Hubert J. Miller Regional Administrator

Docket No. 030-02526
License No. 29-10191-02

Enclosure:
Notice of Violation and Proposed Imposition of Civil Penalty

cc w/encl:
Sreenivasa Murthy, Radiation Safety Officer
State of New Jersey

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

St. Joseph's Hospital and Medical Center Paterson, New Jersey

Docket No. 030-02526 License No. 29-10191-02 EA 97-066

During an NRC inspection conducted on January 13 to 15, and January 30, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG 1600, the NRC proposes 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 violations and associated civil penalty are set forth below:

A. 10 CFR 35.21 (a) requires that the licensee shall appoint a Radiation Safety Officer responsible for implementing the radiation safety program. The licensee, through the Radiation Safety Officer, shall ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program.

Contrary to the above, as of January 30, 1997, the licensee, through the Radiation Safety Officer, did not ensure that radiation safety activities were performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's byproduct material program, as evidenced by violations B through F of this Notice. (01013)

B. 10 CFR 35.70 (b) requires that a licensee shall survey with a radiation detection survey instrument, at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste is stored.

Contrary to the above, as of January 30, 1997, the licensee did not survey with a radiation survey instrument, at least once each week all areas where radiopharmaceutical waste is stored. Specifically the radiopharmaceutical waste storage area in the sub-basement was surveyed only once in each calendar quarter. (01023)

C. Condition 27 to the License number 29-10191-02 dated May 23, 1995 requires, in part, that the licensee shall conduct its program in accordance with the statements, representations, and procedures contained in certain documents, including a letter dated May 22, 1995.

The letter dated May 22, 1995 states, in part, in item No. 3, that the licensee has an iodine-131 air-monitoring system to measure airborne I-131 contamination. The unit is mounted on a rolling cart and will be rolled to the infusion room for air monitoring. Air concentration measurements will start at the beginning of the infusion and will be continuously monitored during the infusion. The air concentration will further be measured and recorded at an interval not to exceed six hours for the duration of the patient's stay in the Radiopharmaceutical Therapy Suite.

Contrary to the above, the licensee did not conduct its program in accordance with statements, representations, and procedures contained in its May 22, 1995 letter. Specifically, the iodine-131 air concentration in the radiopharmaceutical therapy suite was not measured for any of the thirty one patients treated since May 23, 1995. (01033)

D. Condition 27 to the to the licensee's License Number 29-10191-02 dated September 26, 1994 requires, in part, that the licensee shall conduct its program in accordance with statements, representations, and procedures contained certain documents, including a letter dated March 21, 1994.

The letter dated March 21, 1994, states, in Item "Waste Storage (c)" that the waste storage area is monitored with an air survey monitor.

Contrary to the above, the licensee did not conduct its program in accordance with statements, representations, and procedures contained in its March 21, 1994 letter. Specifically, as of January 30, 1997 the waste storage area in the hospital's sub-basement was not monitored with an air survey monitor. (01043)

E. 10 CFR 35.59 (g) requires, in part, that a licensee retain for five years records of quarterly physical inventories of sealed sources and brachytherapy sources in its possession, and that the records contain the model number of each source, and serial number if one has been assigned, the identity of each source radionuclide and its nominal activity, the location of each source, and the signature of the Radiation Safety Officer.

Contrary to the above, as of January 30, 1997, the licensee's records of physical inventory of its sealed calibration sources, and its brachytherapy sources did not contain the signature of the Radiation Safety Officer. Specifically, the September 26, 1996, June 31, 1996, March 31, 1996, and December 19, 1995 records of sealed sources inventories did not contain the signature of the Radiation Safety Officer. (01053)

F. 10 CFR 35.59 (d) requires that a licensee retain records of leakage test results for five years; and that the records contain the model number, and serial number if assigned, of each source tested; the identity of each source radionuclide and its estimated activity; the measured activity of each test sample expressed in microcuries; a description of the method used to measure each test sample; the date of the test; and the signature of the Radiation Safety Officer.

Contrary to the above, as of January 30, 1997, the licensee's records of leakage test results did not contain the signature of the Radiation Safety Officer. Specifically, the June 29, 1996, and January 2, 1996 records of leakage tests of calibration sources did not contain the signature of the Radiation Safety Officer. (01063)

These violations have been categorized in the aggregate as a Severity Level III problem (Supplements VI).
Civil Penalty - $2,750

Pursuant to the provisions of 10 CFR 2.201, St. Joseph's Hospital and Medical Center is 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 violation 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 I.

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 King of Prussia, Pennsylvania
this 25th day of March 1997