United States Nuclear Regulatory Commission - Protecting People and the Environment

EA-98-363 - Nuclear Pharmacy of Idaho, Inc.

October 19, 1998

EA 98-363

Sebastian Ned Gregorio
President and Radiation Safety Officer
Nuclear Pharmacy of Idaho, Inc.
6225 Overland Road
Boise, Idaho 83709

SUBJECT: NOTICE OF VIOLATION
(NRC Inspection Report No. 030-32223/98-01)

Dear Mr. Gregorio:

This refers to the predecisional enforcement conference conducted on August 11, 1998, in NRC's Region IV office in Arlington, Texas. The conference was conducted to review several apparent violations which had been identified during an inspection at Nuclear Pharmacy of Idaho's (NPI's) facility in Boise, Idaho, and during subsequent in-office reviews. The findings of our inspection were discussed with you during a telephonic exit briefing on July 14, 1998.

Based on the information developed during the inspection and the information that you provided during the conference, the NRC has determined that violations of NRC requirements occurred. The 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 most significant violations were associated with an event at your facility on November 13, 1997, involving a spill of iodine-131 (I-131) which contaminated the laboratory and the skin of the authorized nuclear pharmacist. These violations include failures to: (1) perform an evaluation to determine the dose to the skin of the right forearm of the individual involved in the contamination event; (2) limit to 50 rems the annual shallow-dose equivalent to the skin of the individual involved in the contamination event (the individual received an estimated shallow dose equivalent of 115 rems to the skin); and (3) submit a written report within 30 days following the contamination event.

The fact that an individual received a dose to the skin of 115 rems is significant. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, violations associated with a dose to the skin in excess of 100 rems would normally be considered for enforcement at Severity Level II. However, in recognition of the conservatism contained in the calculated result of 115 rems, these violations are instead classified in the aggregate as a Severity Level III problem.

In accordance with the Enforcement Policy, a civil penalty in the base amount of $ 2,750 is considered for a Severity Level III problem. Because your facility has not been the subject of escalated enforcement actions within the last two inspections, 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. NPI's comprehensive corrective actions included closing the retail pharmacy during July 1998, thereby giving the RSO more time to manage and oversee the radiation safety program. In addition, the RSO committed to: (1) attend a 5-day radiation safety course to become more familiar with NRC regulations, (2) hire an independent auditor to observe and review NPI activities to ensure compliance with the license and regulations, and (3) request changes to NPI's license to include use of an additional fume hood and improve its air monitoring program. As a result, the NRC has determined that NPI is deserving of Corrective Action credit.

In addition, the NRC normally considers exercising discretion to escalate a civil penalty in cases involving overexposures. However, in this case, the NRC has decided not to exercise discretion based on the nature of the incident and the good corrective actions taken.

Therefore, to encourage prompt comprehensive correction of violations, and in recognition of the absence of previous escalated enforcement action, I have been authorized not to propose a civil penalty in this case. However, significant violations in the future could result in a civil penalty. In addition, issuance of this Severity Level III violation constitutes escalated enforcement action, that may subject you to increased inspection effort.

In addition to the above cited violations, other violations were identified. These include failures to: (1) use a fume hood authorized by the license for compounding radioiodine; (2) check a dose calibrator for constancy at the beginning of each day of use; (3) store vials of xenon-133 inside a fume hood as specified in procedures referenced in the license; and (4) wear shoulder length gloves while compounding millicurie quantities of iodine-131. These violations were each classified at Severity Level IV in accordance with the Enforcement Policy.

Regarding two other apparent violation described in our inspection report, the NRC has concluded that no violation of regulatory requirements occurred. Section 1 of the inspection report described Apparent Violation 030-32223/9801-01 involving unauthorized use of a nuclear pharmacist. During the conference, you presented information indicating that this individual worked under the supervision of an authorized nuclear pharmacist, not as an authorized nuclear pharmacist himself. Section 3 of the inspection report described Apparent Violation 030-32223/9801-03 involving the failure to perform bioassays at the required intervals. During and after the conference, you presented additional information documenting that the bioassays had been performed.

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 to Violation B, please include the steps you have taken to correct your radiation dose of record. 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,

Org signed by

Ellis W. Merschoff
Regional Administrator

Docket No. 030-32223
License No. 11-27398-01MD

Enclosure: Notice of Violation

cc (w/enclosure):
Idaho Radiation Control Program Director


NOTICE OF VIOLATION
Nuclear Pharmacy of Idaho
Boise, Idaho
Docket No. 030-32223
License No. 11-27398-01MD
EA 98-363

During an NRC inspection conducted on April 21 through July 14, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the violations are listed below:

A.   10 CFR 20.1501 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, as of April 21, 1998, the licensee had failed to perform an adequate survey to assure compliance with 10 CFR 20.1201, which limits radiation exposure to 50 rems shallow dose equivalent to the skin of the whole body. Specifically, the licensee failed to perform an evaluation to determine the quantity of iodine-131 contamination and the radiological hazards to the skin of the right forearm for an authorized nuclear pharmacist involved in an iodine-131 contamination event which occurred on November 13, 1997. (01013)

B.   10 CFR 20.1201(a)(2)(ii) requires that the licensee control the annual occupational dose to individual adults, except for planned special exposures under 10 CFR 20.1206, to a shallow-dose equivalent of 50 rems to the skin or to any extremity.

Contrary to the above, the licensee failed to limit the annual shallow-dose equivalent to the skin of an adult authorized nuclear pharmacist (ANP) to 50 rems during 1997. Specifically, the ANP received an estimated dose of approximately 115 rems shallow-dose equivalent to the skin of his right forearm following a contamination event which occurred on November 13, 1997. (01023)

C. 10 CFR 30.50(c)(2) requires, in part, each licensee who makes a report required by 10 CFR 30.50(b) to submit a written follow-up report within 30 days of the initial report.

Contrary to the above, the licensee failed to submit a written report within 30 days of an initial report made on November 17, 1997, of a contamination event which occurred on November 13, 1997, an event requiring notification by 10 CFR 30.50(b)(2). The written report was submitted on June 4, 1998. (01033)

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

D.   10 CFR 32.72 requires, in part, that a licensee possess and use instrumentation to measure the radioactivity of radioactive drugs and to check each instrument (dose calibrator) for constancy at the beginning of each day of use.

Contrary to the above, between July 1997 and April 21, 1998, the licensee failed to check its dose calibrator for constancy at the beginning of each day of use. Specifically, the licensee routinely performed dose calibrator constancy checks each day of use after the morning radiopharmaceuticals had been prepared and delivered to customer sites for patient administrations. (02014)

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

E.   License Condition 25 requires, in part, that except as specifically provided otherwise in the license, the licensee shall conduct its program in accordance with statements, representations, and procedures contained in the license application dated July 3, 1991.

1.   Section 10.10.3.1 of the application, entitled Special Equipment and Procedures Required For Handling Radioactive Iodine-131, requires the use of shoulder length gloves.

Contrary to the above, while compounding millicurie quantities of iodine-131 on November 13, 1997, the licensee's authorized nuclear pharmacist failed to wear shoulder length gloves.

2.   Section 9.3 of the application, entitled Adequacy of Facility for Handling Xenon-133, specifies, in part, that vials of xenon-133 will be stored in a fume hood which will operate on a continual basis with an air flow velocity not to be less than 100 feet per minute at its exhaust opening.

Contrary to the above, on numerous occasions between February 27, 1997 and April 21, 1998, vials of xenon-133 were stored in an area located outside the fume hood. (03014)

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

F. License Condition 25 requires, in part, that except as specifically provided otherwise in the license, the licensee shall conduct its program in accordance with statements, representations, and procedures contained in the licensee's letters dated August 15 and 25, 1994.

The licensee's letter dated August 15, 1994, informing NRC of the licensee's relocation to its new facility, specifies that radioiodine will be stored in the licensee's fume hood and that iodine will be transferred to the licensee's approved glove box for compounding and dispensing. The licensee's letter dated August 25, 1994, informing NRC that the licensee had completed its move and was now housed at 6225 Overland Road, specifies that the licensee's approved charcoal filtered fume hood and glove box were in place at the licensee's facility.

Contrary to the above, from about February 1998 until April 28, 1998, the licensee used a fume-free hood for compounding millicurie quantities of iodine 131 and this fume-free hood was not authorized by the license. (04014)

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

Pursuant to the provisions of 10 CFR 2.201, Nuclear Pharmacy of Idaho (Licensee) is hereby required to submit a written statement or explanation to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555, with a copy to the Regional Administrator, Region IV, 611 Ryan Plaza Drive, Suite 400, Arlington, Texas 76011, within 30 days of the date of the letter transmitting this Notice of Violation (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" and should include for each violation: (1) the reason for the violation, or, if contested, the basis for disputing the violation or severity level, (2) the corrective steps that have been taken and the results achieved, (3) the corrective steps that will be taken to avoid further violations, and (4) 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 to why the license should not be modified, suspended, or revoked, or why such other action as may be proper should not be taken. Where good cause is shown, consideration will be given to extending the response time.

If you contest this enforcement action, you should also provide a copy of your response to the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.

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).

Dated at Arlington, Texas
this 19th day of October 1998

 

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