EA-97-392 - Windham Community Memorial Hospital, Inc.
February 6, 1998
Mr. Duane A. Carlberg, Chief Operating Officer
Windham Community Memorial Hospital, Inc.
and Hatch Hospital Corporation
112 Mansfield Avenue
Willimantic, Connecticut 06226
|SUBJECT:||NOTICE OF VIOLATION
(NRC Inspection Report No. 030-08728/97-001)
Dear Mr. Carlberg:
This refers to the NRC inspection conducted on July 21-22, 1997 at your facility in Willimantic, Connecticut, and continued in the Region I office on August 6, 1997 to review information telephonically provided to Mr. Louis Manning, NRC Region I, by Dr. Robert Daly, your Radiation Safety Officer (RSO) on that date. During the inspection, the circumstances associated with the falsification of dose calibrator constancy records were reviewed. This falsification was identified by your staff and reported to the NRC. Also, other apparent violations of NRC requirements were identified by the NRC, and were described in the related inspection report sent to you on September 8, 1997. On September 25, 1997, a Predecisional Enforcement Conference (conference) was conducted with you and members of your staff to discuss the violations, their causes, and corrective actions. A copy of the enforcement conference report was sent to you by separate correspondence on November 12, 1997.
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. 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 and the transcript of the conference. The most significant violations, which were identified by your staff and reported to the NRC, involved the creation of false records, namely: (1) the creation of approximately two months of inaccurate records of the daily dose calibrator constancy test by a former Nuclear Medicine Technologist (NMT); and (2) the creation of inaccurate records associated with the disposal of aerosol kits by the NMT Supervisor. These records are required pursuant to 10 CFR 35.50, "Possession, use, calibration, and check of dose calibrators", and 10 CFR 35.92, "Decay-in-storage." These records are required to be complete and accurate pursuant to 10 CFR 30.9, "Completeness and accuracy of information."
Specifically, between March 10, 1997 and May 12, 1997, while the former NMT acted for the NMT Supervisor who was on extended leave, the NMT did not perform the required daily constancy tests of the cobalt-57 source with the dose calibrator, yet entered data into the record to indicate that the tests had been performed. Later, the NMT changed the data after the NMT Supervisor returned and noticed that it was not within the acceptable range. The new entries were fabrications as well. Additionally, as you related at the conference, your investigation determined that the NMT supervisor, upon his return from extended leave in May 1997, fabricated records of dates to document the disposal of radioactive aerosol kits that were held for decay-in-storage during the period when he was on medical leave. The NMT Supervisor could not have had first-hand knowledge of these dates because he had been on medical leave.
The NRC recognizes that you identified these findings and also took a number of corrective actions, including the termination of the NMT, and demotion of the NMT Supervisor to an NMT. Nonetheless, the falsification of NRC required records is a serious regulatory concern since the entire regulatory process is based on the integrity of the staff carrying out licensed activities. The NRC is also concerned that the RSO, as he admitted during the inspection, did not normally review the "day-to-day" operations of your program, and did not normally perform reviews to verify activities were conducted in accordance with requirements. Such oversight may have prevented this problem, or detected it sooner. Given the seriousness of these violations, the involvement of the NMT Supervisor, and the RSO's failure to detect record keeping problems, the 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.
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 Windham Hospital has not previously been the subject of an escalated enforcement action, 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 once you identified the violation, your corrective actions were prompt and comprehensive. These actions, which were described at the conference, included the disciplinary actions against staff personnel; replacement of the RSO; and establishment of a new policy regarding the appropriate methods for creating and revising records.
Therefore, consistent with the enforcement policy, to emphasize the importance of appropriate corrective actions, I have decided, after consultation with the Director, Office of Enforcement, not to propose a civil penalty in this case. But for your corrective actions, the NRC would have considered a civil penalty in this case.
The other three violations (Violations B, C, and D in the Notice) are also described in the Notice and are classified at Severity Level IV.
You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. In addition to addressing the specific violations, your response also should address the issue of increasing management oversight of your licensed program. 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 and its enclosure, will be placed in the NRC Public Document Room (PDR). Your cooperation with us is appreciated.
Hubert J. Miller
Docket No. 030-08728
License No. 06-15203-01
Enclosure: Notice of Violation
State of Connecticut
NOTICE OF VIOLATION
|Windham Memorial Hospital
|Docket No. 030-08728
License No. 06-15203-01
During an NRC inspection conducted on July 21-22, 1997 at the licensee's facility in Willimantic, Connecticut, and continued in the Region I office on August 6, 1997, violations of NRC requirements was identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy, NUREG 1600, the violations are set forth below:
A. 10 CFR 30.9(a) states, in part, that information required by the Commission's regulations to be maintained by the licensee shall be complete and accurate in all material respects.
1. 10 CFR 35.50 requires, in part, that each licensee shall test each dose calibrator for constancy with a dedicated test source at the beginning of each day of use and that the licensee retain a record of each test required by 10 CFR 35.50 for three years unless directed otherwise.
Contrary to the above, between March 10 and May 12, 1997, information required by the Commission's regulations to be maintained by the licensee was not complete and accurate in all material respects, in that constancy tests of the dose calibrator with the cobalt-57 source were not conducted; however, entries were made in the dose calibrator constancy record to indicate that the tests were performed. Specifically,
a. a test value of 325 microcuries was recorded by a Nuclear Medicine Technologist (NMT) for all dates between March 10, 1997, and May 12, 1997, even though the tests were not performed; and,
b. sometime in May 1997, after the NMT Supervisor returned from extended leave and recognized that the cobalt-57 dose calibrator constancy test results were outside the acceptable range, the NMT revised his previous entries (using white out or writing over) by creating new test results that were within the acceptable range. (01013)
2. 10 CFR 35.92(b) requires a record of each disposal permitted under 10 CFR 35.92, "Decay-in-storage." The record must include, in part, the date of the disposal and the date on which the byproduct material was placed in storage.
Contrary to the above, sometime in May 1997, after the NMT Supervisor returned from extended leave, the NMT Supervisor created inaccurate records of dates to document the disposal of radioactive aerosol kits that had been held for decay-in-storage during the period when he was on leave. The NMT supervisor did not have first-hand knowledge of the actual dates because the dates occurred during the period when he was on extended leave. (02013)
These violations represent a Severity Level III problem (Supplement VII).
B. 10 CFR 35.22(a)(3) requires that to establish a quorum and conduct business, at least one half of the Radiation Safety Committee's membership must be present, including the Radiation Safety Officer and management's representative.
Contrary to the above, on September 24, 1996, the licensee's Radiation Safety Committee met and conducted business, and a quorum was not established in that less than one half of the committee's membership were present. (02014)
This is a Severity Level IV violation (Supplement VI).
C. 10 CFR 35.75(a) requires, in part, that a licensee not authorize release from confinement for medical care any patient administered a radiopharmaceutical until the measured dose rate from the patient is less than 5 millirems per hour (mr/hr) at a distance of one meter (1997 revision not applicable).
Contrary to the above, on May 11, June 12, and September 8, 1995, the licensee released patients from confinement without first measuring the dose rate at a distance of one meter from these patients to ensure that the measured dose rates were below 5 millirems per hour. Specifically, the licensee released patients who had received 30 millicuries of sodium iodide iodine-131 on May 11, June 12, and September 8, 1995, and, at the time of release, the licensee did not measure the dose rate at one meter from the patients. (03014)
This is a Severity Level IV violation (Supplement VI).
D. Condition 15 of License No. 06-15203-01 requires the licensee to conduct its program in accordance with the statements, representations, and procedures contained in License Application dated July 26, 1995.
Item 10.4 of the License Application states, that the licensee will comply with the model procedures of Appendix I of Regulatory Guide 10.8, Revision 2.
Item 5 of Appendix I requires, that personnel are not to eat, drink, smoke, or apply cosmetics in any area where radioactive material is stored or used.
Contrary to the above, the licensee did not conduct its program in accordance with the statements, representations, and procedures contained in License Application dated July 26, 1995. Specifically, on July 21, 1997, the inspector observed evidence of drinking in the cardiac stress lab in that there were several cups containing water and ice, and a trash can containing two tea bags, and licensee staff acknowledged that these items belonged to them. (04014)
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Windham Hospital 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.
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, D.C. 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). 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 6th day of February 1998