EA-02-172 - Pacific Radiopharmacy, Ltd.

March 27, 2003

EA-02-172
EA-02-246

Mr. Myron Tong, President
Pacific Radiopharmacy, Ltd.
347 North Kuakini Street
Honolulu, Hawaii 96817

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTIES - $9,000 (NRC INSPECTION REPORT 030-12031/02-01, AND OFFICE OF INVESTIGATIONS REPORT NO. 4-2002-013)

Dear Mr. Tong:

This refers to the predecisional enforcement conference conducted on October 10, 2002, in the Federal Building in Honolulu, Hawaii. The conference was conducted to discuss several apparent violations of NRC requirements identified during our inspection and investigation which were conducted at your facility in Honolulu, Hawaii. The findings included a significant overexposure to an extremity (i.e., a finger) and separate apparent violations that may have involved willfulness. These findings were discussed with you and members of your staff on September 6, 2002, and were documented in the subject NRC inspection report which was issued on September 12, 2002.

Based on the information developed during the inspection and investigation, and the information that you provided during the conference, the NRC has determined that several 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 first two violations include: (1) a failure to limit the occupational dose to an individual adult to the shallow-dose equivalent of 0.50 Sv (50 rem) to any extremity; and (2) the failure to make, or cause to be made, surveys that are necessary to comply with 10 CFR20.1201(a)(2)(ii). The third violation encompasses five failures to comply with the terms and conditions of the license and includes: (a) failures to wear personnel monitoring devices in areas where radioactive materials are used and stored; (b) failures to wear finger badges while eluting, preparing, assaying, or dispensing millicurie quantities of radioactive materials; (c) eating in areas where radioactive materials are used or stored; (d) failures to monitor hands and clothing for contamination when an individual leaves the restricted area; and (e) a failure by the radiation safety officer (RSO) to ensure compliance with the rules, regulations, and conditions of the NRC license.

The first two violations relate to the overexposure of a radiopharmacist's finger. Specifically, a radiopharmacist used a vial shield without the shielded top which made it necessary for him to use his index finger to hold the vial in place within the shield while withdrawing a dosage. The vials normally contained millicurie quantities of technetium-99m. An NRC inspector observed the radiopharmacist's technique and requested that Pacific Radiopharmacy evaluate the doses to the finger. Your consultant estimated the finger was exposed to 700 rem in calendar year 2001, and to 140 rem in calendar year 2002. You subsequently revised the estimate to 500 rem in calendar year 2001. While this revised calculation has not been reviewed by the NRC, it remains an exposure significantly in excess of the 50 rem limit. Based on the overexposure, which could have been prevented by merely using a shielded top for the vial shield, and the failure to evaluate the dose delivered to the radiopharmacist's finger, the first two violations are categorized collectively in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600 as a single Severity Level I problem.

As stated earlier, the third violation involves five examples of Pacific Radiopharmacy's failure to comply with the terms and conditions of its license. The NRC has concluded that willfulness was involved in three of the examples. The NRC has concluded that your employees displayed a careless disregard for the requirements to wear personal monitoring devices in areas where radioactive materials are used and stored, and to wear finger badges while eluting, preparing, assaying, or dispensing millicurie quantities of radioactive material. In addition, the NRC has concluded that both the Executive Director and the former RSO engaged in deliberate misconduct when they failed to monitor their hands and clothing for contamination when leaving the restricted area. The Executive Director told the OI investigator and the inspector that he monitored his hands and clothing occasionally when leaving the restricted area, but that it was something he did not do on a regular basis. During the conference, he denied that he deliberately failed to monitor himself, but said he might have forgotten on occasion. We did not find his statements at the conference to be credible, based in part, on his extensive training and experience, and on his statements to the investigator and the inspector. The former RSO admitted he knew the requirement, but stopped adhering to it because he observed that nobody else adhered to it.

Although two lower level Pacific Radiopharmacy staff members failed to monitor their hands and clothing when leaving the restricted area, the NRC did not conclude that these failures were willful. This is based on their statements that they did not understand they were required to monitor themselves each (and every) time they exited the restricted area. All five examples of this violation have the same underlying cause, namely that the RSO and Licensee management failed to train Pacific Radiopharmacy employees in NRC requirements effectively, and failed to provide effective oversight of its radiation safety program. Due to the willfulness and the potential safety consequences, these five examples of the third violation are categorized collectively in accordance with the Enforcement Policy as a single Severity Level III violation.

In accordance with the Enforcement Policy, a civil penalty in the base amount of $6,000 was considered for the Severity Level I problem and, in addition, a civil penalty in the base amount of $3,000 was considered for the Severity Level III violation. 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 for both the Severity Level I problem and the Severity Level III violation. In reviewing the circumstances surrounding these violations, the NRC has determined that, in each case, Pacific Radiopharmacy is not deserving of Identification credit since it was an NRC inspector who questioned the radiopharmacist's practice of holding the vial with his finger, requested that Pacific Radiopharmacy assess the doses to the finger, and identified all of the examples of the third violation. However, the NRC has concluded that credit is warranted, in each case, for your corrective actions which include: suspending the radiopharmacist from further work with radioactive material; discontinuing the practice of using vial shields without tops; providing additional equipment to ensure that individuals do not come in direct contact with unshielded radiopharmaceutical vials; contracting with an individual to be the new RSO; requiring the new RSO to observe and modify as necessary your staff's dose-drawing techniques to ensure ALARA concepts are appropriately implemented; providing additional training to your staff; requiring the new RSO to perform random unannounced visits to the facility periodically to ensure your staff is adhering to NRC and company rules; and purchasing and installing new frisker monitors.

Therefore, to emphasize the importance of prompt identification of violations, and to deter willful violations, I have been authorized, after consultation with the Director, Office of Enforcement, the Deputy Executive Director for Materials, Research, and State Programs, and the Commission, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalties (Notice) in the total amount of $9,000.

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, the enclosed Notice, and your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), from the NRC Web site at the Public NRC Library. The NRC also includes significant enforcement actions on its Web site.

		Sincerely,
		/RA/
		Ellis W. Merschoff Regional Administrator

Docket No. 030-12031
License No. 53-16991-01MD

Enclosure: Notice of Violation and Proposed Imposition of Civil Penalties

cc:
Hawaii Radiation Control Program Director

Mr. Darryl N. Ing
Senior Vice President & Chief Operating Officer
Kuakini Medical Center
347 North Kuakini Street
Honolulu, Hawaii 96817

Mr. Ronald Frick
Radiation Safety Officer
Pacific Radiopharmacy Ltd.
347 North Kuakini Street
Honolulu, Hawaii 96817

---

ENCLOSURE 1

NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTIES

Pacific Radiopharmacy, Ltd. Honolulu, Hawaii

Docket No. 030-12031 License No. 53-16991-01MD EA-02-172; EA-02-246

During an NRC inspection and investigation which were concluded on September 6, 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 civil penalties 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 penalties are set forth below:

A.	(1)	10 CFR 20.1201(a)(2)(ii) requires, in part, that the licensee control the annual occupational dose to individual adults to a shallow-dose equivalent of 50 rem to any extremity. Contrary to the above, for calendar years 2001 and 2002, the licensee failed to control the annual occupational dose to an individual adult to a shallow-dose equivalent of 50 rem to an extremity. Specifically, a radiopharmacist received an overexposure to his finger estimated by the licensee to be 500 rem for calendar year 2001, and 140 rem for the period between January 1, 2002, through March 13, 2002. The radiopharmacist used a vial shield without the shielded top which made it necessary for him to hold the vial in place using his index finger while drawing dosages.
	(2)	10 CFR 20.1501(a) requires, in part, that the 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 magnitude and extent of radiation levels 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, between January 1, 2001 and March 6, 2002, the licensee failed to make surveys to assure compliance with 10 CFR 20.1201(a)(2)(ii), which limits the shallow-dose equivalent to any extremity to 50 rem. Specifically, the licensee had not evaluated the dose delivered to an Authorized Nuclear Pharmacist's finger that resulted from routine contact with unshielded vials when drawing dosages. The subsequent dose to the individual's finger was in excess of 50 rem. This is a Severity Level I problem (Supplement IV). Civil Penalty - $6,000. (EA-02-172)
B.	10 CFR 30.34(c) requires, in part, that the licensee confine its possession and use of byproduct material to the location and purpose authorized in the license. License Condition 19-A requires, in part, that the licensee comply with the application dated March 29, 1994. Section 7.2 of the application specifically outlines the Radiation Safety Officer's (RSO) duties and responsibilities. Item 10 of the application outlines the licensee's Radiation Safety Program. Section 10.7 of the Radiation Safety Program is entitled, "General Rules for Safe Use of Radioactive Material" (General Rules), and details the licensee's own specific requirements for the safe use of radiopharmaceuticals. No. 3 of the licensee's General Rules requires, in part, that individuals shall monitor hands and clothing for contamination when an individual leaves the restricted area. No. 5 of the licensee's General Rules requires, in part, that individuals shall not eat, drink, smoke, or apply cosmetics in any area where radioactive materials are used or stored. . 10 of the licensee's General Rules requires, in part, that individuals shall always wear personnel monitoring devices in areas where radioactive materials are used or stored. No. 11 of the licensee's General Rules requires, in part, that individuals who elute, prepare, assay, or dispense millicurie quantities of radioactive material shall always wear finger badges. Item B of Section 7.2 requires, in part, that the RSO ensure compliance with the rules, regulations, and conditions of the NRC license. Contrary to the above, prior to March 6, 2002, the licensee failed to comply with the terms and conditions of the licensee. Specifically, multiple staff members failed to consistently wear personnel monitoring devices, including whole body and finger dosimetry when in the restricted area, and failed to monitor their hands and clothing for contamination when leaving the restricted area. Licensee staff members admitted to eating while in the restricted area. Lastly, the licensee's RSO failed to ensure compliance with NRC rules and regulations, in that, he was aware that employees were not in compliance with NRC and license requirements, but took inadequate action to require compliance. This is a Severity Level III violation (Supplement VI). Civil Penalty - $3,000. (EA-02-246)

Pursuant to the provisions of 10 CFR 2.201, Pacific Radiopharmacy, Ltd. (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 Penalties (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation; EA-02-172 and EA-02-246," 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 penalties 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 penalties 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 of Violation and Proposed Imposition of Civil Penalties, an order imposing the civil penalties will be issued. Should the Licensee elect to file an answer in accordance with 10 CFR 2.205 protesting the civil penalties, 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 penalties should not be imposed. In addition to protesting the civil penalties in whole or in part, such answer may request remission or mitigation of the penalties.

In requesting mitigation of the proposed penalties, 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 civil penalties.

Upon failure to pay any civil penalties due which subsequently have been determined in accordance with the applicable provisions of 10 CFR 2.205, this matter may be referred to the Attorney General, and the penalties, 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 penalties, and Answer to a Notice of Violation) should be addressed to: Mr. 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 IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011.

Because your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), to the extent possible, it should not include any personal privacy, proprietary, or safeguards 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 are required to post this Notice within two working days.

Dated this 27th day of March 2003