EA-96-008 - Corning Clinical Laboratories
Mr. David Zewe, General Manager
Corning Clinical Laboratories
900 Business Center Drive
Horsham, Pennsylvania 19044
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report Nos. 030-30859/96-001 and 030-19983/96-001)
Dear Mr. Zewe:
This refers to the inspection conducted on December 14 and 18, 1995, at your Horsham, Pennsylvania facility. The inspection was continued in the Region I office on January 10, 1996, to review additional information submitted on that date regarding the closeout of your facility in Trevose, Pennsylvania. The purpose of the inspection was to determine whether authorized licensed activities as they relate to radiation safety and to compliance were conducted safely and in accordance with NRC requirements. At the conclusion of the inspection, the findings were discussed with you, Dr. Katherine Erickson, and other members of your staff. The inspector identified eight apparent violations during the inspection which were described in the NRC inspection report transmitted with our letter dated January 29, 1996. On February 29, 1996, a predecisional enforcement conference was held with you, as well as members of your staff and the Corning Clinical Laboratories Corporate office to discuss the violations, their causes, and your corrective actions. The enforcement conference report will be sent to you by separate correspondence.
Based on the information developed during the inspection, and the information provided during the conference, the NRC has determined that 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 violations involve: (1) failure to maintain records of termination surveys of the Trevose facility; (2) failure to dispose of radioactive materials by required procedures prior to closing the Trevose facility and releasing it for unrestricted use; (3) failure to follow radioactive waste disposal procedures for solid radioactive waste; (4) failure to perform personnel surveys; (5) failure to perform radioactive waste surveys; (6) failure to train individuals; (7) failure to maintain disposal records; and (8) failure to maintain wipe test results in the units specified in 10 CFR 20.1005.
The violations collectively demonstrate that a significant breakdown in the control of licensed activities existed at your facilities. The NRC entrusts responsibility for radiation safety to management and the radiation safety officer (RSO). Therefore, the NRC expects effective oversight of its licensed programs. Incumbent upon each NRC licensee is the responsibility for management in general, and the RSO in particular, to protect the public health and safety by ensuring that all requirements of the NRC license are met and any potential violations of NRC requirements are identified and corrected expeditiously. Given the lack of management attention towards licensed responsibilities, these violations are 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 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. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions, which were discussed during the conference, include the following: (1) providing training to all staff in survey procedures, wipe test procedures, and waste disposal procedures; (2) implementing an auditing system for facilities to be closed; (3) implementing the use of a new form for recording surveys, wipe test results, and waste disposal; and (4) retaining records for facilities that are to be closed at the corporate office.
Therefore, to encourage 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.
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 should document the specific actions taken and any additional actions you plan to prevent recurrence. After reviewing your response to this Notice, including your proposed corrective actions and the results of future inspections, the NRC will determine whether further NRC enforcement action is necessary to ensure compliance with NRC regulatory requirements.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, its enclosures, and your response will be placed in the NRC Public Document Room (PDR). To the extent possible, your response should not include any personal privacy, proprietary, or safeguards information so that it can be placed in the PDR without redaction.
The responses directed by this letter and the enclosed Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, Pub. L. No. 96.511.
Sincerely, Thomas T. Martin Regional Administrator
Docket Nos. 030-30859; 030-19983
License Nos. 37-28294-01; 37-15290-02
Enclosure: Notice of Violation
Linda Dickson, Radiation Safety Officer
Katherine Erickson, Technical Director
Commonwealth of Pennsylvania
Corning Clinical Laboratories, Inc. Docket Nos. 030-30859; 030-19983 Horsham, Pennsylvania License Nos. 37-28294-01; 37-15290-02 EA 96-008
During an NRC inspection conducted on December 14 and 18, 1995, and January 10, 1996, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedures for NRC Enforcement Actions," NUREG 1600, the violations are listed below:
A. 10 CFR 20.2001(a) requires that the licensee dispose of licensed material only by certain specified procedures.
Contrary to the above, on January 21, 1995, the licensee disposed of iodine-125 (125I) contaminated waste by release to non-radioactive trash, a method not authorized by 10 CFR 20.2001. Specifically, at the Trevose facility, on January 21, 1995 the licensee (License No. 37-15290-02) released 125I contaminated waste with readings above background (5 to 7 microroentgen per hour) to a medical waste broker, who was not licensed to receive such materials. (01013)
B. Condition 14 of License No. 37-28294-01 states, in part, that the licensee shall conduct its program in accordance with the statements contained in a letter dated January 19, 1995. Item 10, paragraph C.2. of the letter dated January 19, 1995 states that dry radioactive materials, including test tubes, empty isotope bottles, and contaminated absorbent paper must be placed directly into the radioactive waste container.
Contrary to the above, on December 14, 1995, the licensee did not dispose of dry radioactive material, including test tubes, empty isotope bottles, and contaminated paper directly into the radioactive waste container. Specifically, at the Horsham facility, on December 14, 1995, a radioimmunoassay (RIA) technologist disposed of 125I radioactive material into a bio-hazardous waste bag, a method not authorized by license condition. (01023)
C. 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, between the period January 1, 1994 and December 18, 1995, the licensee did not make or cause to be made surveys that may be necessary for the licensee to comply with the regulations in Part 20. Specifically, the licensee did not make surveys, to assure compliance with 10 CFR 20.2001(a), which describes authorized means of disposing of licensed material. The licensee did not perform surveys, at the Horsham facility, before disposing of waste which could have potentially contained 125I, in the non-radioactive trash or bio-hazardous trash bags. (01033)
D. 10 CFR 20.1005 requires that activity be expressed in the special unit of curies (Ci) or in the SI unit of becquerels (Bq), or their multiples, or disintegrations per unit of time.
Contrary to the above, between the period January 1, 1994 to December 18, 1995, the licensee did not express activity in the units required by 10 CFR 20.1005. Specifically:1) weekly wipe test results for the Horsham facility were expressed in counts per minute (cpm), not disintegrations per unit time (dpm) as required, and
2) termination surveys performed for the Trevose facility (License No. 37-15290-02) were expressed in cpm, not dpm as required. (01043)
E. Condition 14 of License No. 37-28294-01 states in part, that the licensee shall conduct its program in accordance with the statements, representa-tions, and procedures contained in the license application dated June 2, 1994. Item 10, paragraph D.2.C., of the application dated June 2, 1994, states that lab coats are to be checked with a survey meter to detect contamination.
Contrary to the above, as of December 14, 1995, the licensee did not check lab coats with a survey meter to detect contamination. Specifically, at the Horsham facility, radioimmunoassay (RIA) technologists failed to perform personal monitoring to verify that their lab coats were not contaminated. (01053)
F. 10 CFR 19.12 requires, in part, that all individuals working in a restricted area be instructed in the precautions and procedures to minimize exposure to radioactive materials, in the purpose and functions of protective devices employed, and in the applicable provisions of the Commission's regulations and licenses.
Contrary to the above, as of December 14, 1995, individuals working in the RIA laboratory, a restricted area, had not been instructed in all of the applicable provisions of the regulations and the conditions of the license. Specifically, at the Horsham facility, personnel were not familiar with the license condition to survey lab coats, and regulatory requirements for performing surveys before disposing of waste in the normal trash and bio-hazardous trash bags located in areas of use. (01063)
G. 10 CFR 20.2103(a) requires, in part, that each licensee maintain records of the results of surveys required by 10 CFR 20.1501. The licensee shall retain these records for 3 years after the record is made.
Contrary to the above, as of January 10, 1996, the licensee did not maintain records of the results of surveys performed in July, 1994 and February, 1995, and these surveys were required by 10 CFR 30.36. Specifically, on January 10, 1996, the licensee faxed signed affidavits indicating that termination surveys were completed prior to vacating the Trevose facility (License No. 37-15290-02); however, records of these surveys were not maintained. (01073)
H. 10 CFR 20.2108 requires, in part, that each licensee maintain records of the disposal of licensed materials made under 10 CFR 20.2003.
Contrary to the above, during the period between January 1, 1994, and December 18, 1995, 125I waste at the Horsham facility was disposed by release into the sanitary sewerage, and the licensee did not adequately maintain records of these disposals. Specifically, the licensee collected liquid radioactive waste into a glass beaker, and disposed of the material into the sanitary sewerage without maintaining a record of the date, amount of material, the material, and the initials of the person making the disposal. (01083)
These violations represent a Severity Level III problem (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Corning Clinical Laboratories, Inc. 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 I, 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, (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.
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. However, if you find it necessary to include such information, you should clearly indicate the specific information that you desire not to be placed in the PDR, and provide the legal basis to support your request for withholding the information from the public.
Dated at King of Prussia, Pennsylvania
this 12th day of March, 1996