EA-03-204 - U. S. Inspection Services

June 15, 2004

EA-03-204
NMED No. 030726

Mr. Jim Bailey, President
U.S. Inspection Services
705 Albany Street
Dayton, OH 45408

SUBJECT:

NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$19,200 (NRC REACTIVE INSPECTION REPORT NO. 03035059/2003(DNMS) AND NRC OFFICE OF INVESTIGATIONS REPORT NO. 3-2004-002)

Dear Mr. Bailey:

This refers to the reactive inspection conducted on September 12, 2003, at your Dunbar, West Virginia field station and a temporary job site in Charleston, West Virginia, and a subsequent follow up inspection at your Dayton, Ohio office on October 29 and 30, 2003. The purpose of the inspections was to obtain information surrounding the circumstances related to a reported overexposure event that occurred on September 9, 2003. The inspection report issued on November 26, 2003, documented seven apparent violations of NRC requirements involving an overexposure to a radiographer. The NRC Office of Investigations (OI) also conducted an investigation to determine whether personnel employed by U.S. Inspection Services willfully violated NRC requirements.

On January 6, 2004, a predecisional enforcement conference was conducted in Region III with you and members of your staff to discuss the significance and root cause(s) of the apparent violations, and corrective actions that you have taken or planned to take to prevent recurrence. During the conference you agreed with the violations presented by the NRC and provided a discussion of corrective actions that had been or would be implemented. Enclosure 2 is a copy of the slides that were presented by you and your staff at the conference.

Based on our evaluation of the information obtained during the inspections and from the letter you provided to the NRC on January 5, 2004, and information that you provided during the conference, the NRC has determined that seven violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) (Enclosure 1) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involved the failure to: (1) ensure that occupational personnel do not accrue a cumulative radiation dose in excess of the regulatory limits; (2) conduct a radiation survey; (3) calibrate a survey instrument after it was repaired; (4) test an alarming ratemeter for operability before use; (5) follow established procedures to ensure that a sealed source contained in a radiographic device was in the locked, shielded position prior to approaching the device; (6) conduct a daily inspection of a radiographic exposure device and associated safety equipment; and (7) ensure that equipment modifications did not compromise the design safety features of the cable and drive crank assembly. In addition, results of the OI investigation concluded that none of the violations were willful. The OI report synopsis is provided as Enclosure 3.

During radiographic operations conducted at a temporary jobsite on September 9, 2003, two radiographers employed by U.S. Inspection Services failed to comply with several NRC requirements, associated license conditions and licensee procedures. These failures were directly related to an occupational overexposure to one radiographer. The individual received a deep dose equivalent of approximately 20.5 rem (and a corresponding cumulative annual total effective dose equivalent (TEDE) exceeding 21.5 rem) whole body, a shallow dose equivalent (SDE) of 140 rem to the skin of the whole body, and 235 rem to the skin of an extremity, all of which were well above the allowable annual regulatory limits of 5 rem and 50 rem respectively. No immediate health effects have been observed as a result of the overexposures.

The NRC considers these violations to be a very significant safety concern because an individual received a TEDE and a SDE that were in excess of four times the annual regulatory limit. Furthermore, there was the potential for a more significant radiation exposure if the exposure to radiation had been longer and/or the radiographic device used during the event contained a sealed source with more activity. Additionally, and more important, this event would not have occurred had personnel employed by U.S. Inspection Services complied with the regulatory requirements and the licensee's procedures. Therefore, these violations are categorized collectively in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600, as a Severity Level II problem.

In accordance with the Enforcement Policy, a base civil penalty in the amount of $9600 is considered for a Severity Level II problem. Because your facility has been the subject of escalated enforcement actions within the last two years,⁽¹⁾ 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. Credit is not warranted for identification because identification of the violations occurred as a result of the overexposure and given the fact that the NRC identified virtually all the violations during the reactive inspection that was conducted subsequent to the event. Credit is warranted for corrective actions based on the licensee's response to correct the violations and to prevent a recurrence, specifically, U.S. Inspection Services: (1) conducted required maintenance on all radiographic exposure devices and associated equipment; (2) verified that all applicable staff possessed current copies of the licensee's operating and emergency manuals; (3) numbered all crank assemblies, guide tubes, and extensions for traceability purposes; (4) removed equipment with damaged or missing hardware from service until items were repaired; (5) instituted corporate radiation safety officer (CRSO) notification of potential equipment condition deficiencies before use; (6) implemented a program for CRSO review of radiation safety related field office documentation; (7) provided comprehensive, mandatory training for all radiographic personnel; (8) replaced the CRSO and added two assistant CRSOs to assist the CRSO in the administration of the radiation protection program; and (9) contracted with an outside contractor to conduct an independent audit of the radiation safety program.

Although the NRC recognizes that application of the civil penalty assessment process described in Section VII.C.2 of the Enforcement Policy would result in a base civil penalty in this case, the NRC is exercising discretion in accordance with Section VI.A.1(c) of the Enforcement Policy and is proposing a civil penalty at twice the base amount for your staff's particularly poor performance that preceded and was directly related to the overexposure event. Specifically, U.S. Inspection Services' management missed numerous opportunities to identify and correct the staff's inadequate understanding and implementation of routine licensed activities including the proper repair, testing, and day-of-use checks of radiographic safety equipment. In addition, management's poor oversight of radiographic equipment maintenance hindered your ability to detect inadequate and inappropriate modifications, repairs, and tests of radiographic safety equipment. The lack of management oversight of the radiation safety program significantly contributed to creating the conditions that led to the overexposure event.

Therefore, to emphasize the importance of complying with the regulatory requirements, ensuring that your personnel adhere to and follow procedures, providing appropriate management oversight of the radiation safety program, identifying violations, and implementing prompt and comprehensive corrective action for violations, and in recognition of your previous escalated enforcement action, I have been authorized, after consultation with the Director, Office of Enforcement, and the Deputy Executive Director for Materials, Research and State Programs, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $19,200, or twice the base amount, for the Severity Level II problem. In addition, issuance of this Notice constitutes escalated enforcement action, that may subject you to increased inspection effort.

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in Inspection Report No. 03035059/2003(DNMS), and U.S. Inspection Services' letter dated January 5, 2004. Therefore, you are not required to respond to the provisions of 10 CFR 2.201 unless the descriptions in our inspection report and your letter do not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

In accordance with 10 CFR 2.390 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response, if any, will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS), which is accessible from the NRC Web site at the Public NRC Library. The NRC also includes Issued Significant Enforcement Actions on its Web site.

		Sincerely,
		/RA/
		James L. Caldwell Regional Administrator

Docket No. 030-35059
License No. 34-06943-02

Enclosure:
1. Notice of Violation and Proposed Imposition of Civil Penalty
2. Enforcement Conference Slides
3. OI Report Synopsis
4. NUREG/BR-0254 Payment Methods (Licensee only)

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NOTICE OF VIOLATION
AND
PROPOSED IMPOSITION OF CIVIL PENALTY

U.S. Inspection Services Dayton, Ohio

Docket No. 030-35059 License No. 34-06943-02 EA-03-204 NMED No. 030726

During an NRC inspection conducted on September 12 and October 29-30, 2003, 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:

A.	10 CFR 20.1201 requires, in part, that the licensee control the occupational dose to individual adults to an annual limit of 5 rem total effective dose equivalent; 15 rem to the lens of the eye, and 50 rem to the skin of the whole body or skin of any extremity. Contrary to the above, on September 9, 2003, the licensee failed to control the annual occupational dose to an adult to 5 rem total effective dose equivalent, 50 rem to the skin of the whole body, and 50 rem to the skin of any extremity. Specifically, a radiographer received a 20.5 rem total effective dose equivalent (a cumulative total effective dose equivalent exceeding 21.5 rem), a 140 rem shallow dose equivalent to the skin of the whole body, and a 235 rem shallow dose equivalent to the skin of an extremity, all in excess of the annual occupational dose.
B.	10 CFR 34.49(b) requires, in part, that the licensee shall, using a survey instrument, conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube to determine that the sealed source has returned to its shielded position before exchanging films, repositioning the exposure head, or dismantling equipment. Contrary to the above, on September 9, 2003, the licensee failed to conduct a survey of the radiographic exposure device and the guide tube after each exposure when approaching the device or the guide tube. Specifically, a radiographer conducted an inadequate survey of the radiographic exposure device by failing to determine that the sealed source was not in its shielded position prior to exchanging film and repositioning the exposure head.
C.	10 CFR 34.25(b)(1) requires, in part, that each radiation survey instrument be calibrated at intervals not to exceed 6 months and after instrument servicing, except for battery changes. Contrary to the above, in May of 2003, the licensee serviced a survey instrument and did not have it calibrated. Specifically, the licensee repaired an NDS Model ND-2000 survey instrument, Serial No. 2755, in May 2003 and used this uncalibrated instrument to perform required radiation surveys on several occasions between May 2003 and September 9, 2003.
D.	10 CFR 34.20(b)(3) specifies that modification of radiographic exposure devices, source changers, and source assemblies and associated equipment is prohibited, unless the design of any replacement component, including source holder, source assembly, and controls or guide tubes, would not compromise the design safety features of the system. Condition 21 of License No. 34-06934-02 requires, in part, that the licensee conduct its radiation safety program in accordance with the statements, representations, and procedures contained in the letter dated June 5, 2001. Attachment No. 1, "Quarterly Inspection and Maintenance of Iridium/Cobalt/Cesium Exposure Devices," of Procedure RS-GP-9, Revision 2, "Inspection and Maintenance of Radiographic Exposure Devices, Transport/Storage Containers, Associated Equipment, and Survey Instruments," attached to the letter dated June 5, 2001, states that modification of any exposure device and associated equipment is prohibited, unless the design of any replacement component would not compromise the design safety feature of the system. Contrary to the above, an exposure device component, specifically, the source crank assembly, was modified by the licensee and this modification directly compromised the design safety feature of the system, in that, the licensee used parts from two damaged crank assemblies to assemble one working crank. The modified crank assembly did not contain the wear strip, the brake latch, or two of four required bolts used to hold the crank together, all of which were necessary components critical to safety. The modified crank assembly was subsequently used to conduct radiographic operations on August 12, August 18, and September 9, 2003.
E.	10 CFR 34.20 (c)(2) states, in part, that the radiographic exposure device must automatically secure the source assembly when it is cranked back into the fully shielded position within the device. This securing system may only be released by means of a deliberate operation on the exposure device. Condition 21 of License No. 34-06934-02 requires, in part, that the licensee conduct its radiation safety program in accordance with the statements, representations, and procedures contained in the facsimile dated October 23, 2002. Item 2.16.1 of Procedure RS-5-1, "Operating Instructions for Technical Operations Models 660, 680, & 741 Series Exposure Devices (Projectors)," attached to the facsimile dated October 23, 2002, states, in part, that after source retraction, apply a slight amount of forward pressure on the crank handle, as to expose the source, to ensure that the positive locking mechanism has actuated. Contrary to the above, on September 9, 2003, the licensee failed to ensure that the radiographic exposure device automatically secured the source assembly when it was cranked back into the shielded position after source retraction and failed to apply a slight amount of forward pressure on the crank handle as to expose the source, to ensure that the positive locking mechanism was actuated.
F.	10 CFR 34.31(a) requires, in part, that the licensee perform visual and operability checks on radiographic exposure devices, transport and storage containers, and associated equipment before use on each day the equipment is to be used to ensure that the equipment is in good working condition, the sources are adequately shielded, and that required labeling is present. Condition 21 of License No. 34-06934-02 requires, in part, that the licensee conduct its radiation safety program in accordance with the statements, representations, and procedures contained in the letter dated June 5, 2001. Item 3.0 of Procedure RS-GP-9, "Inspection and Maintenance of Radiographic Exposure Devices, Transport/Storage Containers, Associated Equipment, and Survey Instruments," attached to the letter dated June 5, 2001, states, in part, that the radiographer/assistant radiographer check before use on each day the equipment is to be used: (1) the camera for damage to fittings, lock, fasteners and labels; and (2) the crank for damage and loose hardware. Contrary to the above, on September 9, 2003, radiography personnel failed to check the radiographic exposure device and associated equipment as required. Specifically, radiography personnel did not check: (1) the camera for damage to fittings, lock, fasteners and labels; and (2) the crank for damage and loose hardware.
G.	10 CFR 34.47(g)(1) requires that each alarm ratemeter be checked to ensure that the alarm functions properly (sounds) before using the ratemeter at the start of each shift. Condition 21 of License No. 34-06934-02 requires, in part, that the licensee conduct its radiation safety program in accordance with the statements, representations, and procedures contained in the letter dated August 10, 2001. Item 3.3 of Procedure RS-GP-2, Revision 3, "Personnel Monitoring Equipment and Usage," attached to the letter dated August 10, 2001, requires, in part, that each radiographer/assistant radiographer wear an assigned rate alarm meter; check the battery and audio tone by pressing the push button at the arrow and verifying that the LED illuminates and the alarm sounds; and do not use the rate alarm meter if either test fails. Contrary to the above, on September 9, 2003, a radiographer's assistant failed to perform the required battery and audio tone tests on his assigned rate alarm meter (NDS Products Model RA-500, Serial No. 29895). Specifically, the radiographer's assistant failed to press the button at the arrow and verify that the LED illuminated and the alarm sounded.

This is a Severity Level II problem (Supplements IV and VI).
Civil Penalty – $19,200

The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence, and the date when full compliance was achieved, is already adequately addressed on the docket in Inspection Report No. 03035059/2003(DNMS), and U.S. Inspection Services' letter dated January 5, 2004. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the descriptions in our report and your letter do not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation; EA-03-204" and send it within 30 days of the date of the letter transmitting this Notice of Violation (Notice).

The licensee may pay the civil penalty proposed above in accordance with NUREG/BR-0254 and by submitting to the Director, Office of Enforcement, a statement indicating when and by what method payment was made, or may protest imposition of the civil penalty in whole or in part, by a written answer addressed to the Director, Office of Enforcement. 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.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 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 234(c) of the Act, 42 U.S.C. 2282c.

The response noted above (Reply to Notice of Violation, statement as to payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: 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 III, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4351.

If you choose to respond, your response will be made available electronically for public inspection in the NRC Public Document Room or from the NRC's document system (ADAMS). ADAMS is accessible from the NRC Web site at the Public NRC Library. Therefore, to the extent possible, the response should not include any personal privacy, proprietary, or safeguards information so that it can be made available to the Public without redaction.

In accordance with 10 CFR 19.11, you may be required to post this Notice within two working days.

Dated this 15^th day of June 2004.

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^1. A Severity Level III violation was issued on November 29, 2002, for failure to have two qualified individuals observe radiographic operations (EA-02-201).