EA-97-613 - Wood River Medical Center
April 27, 1998
Healthcare Authority dba
Wood River Medical Center
ATTN: Jon Moses, CEO
P.O. Box 86
Sun Valley Location
Sun Valley, Idaho 83353
|SUBJECT:||NOTICE OF VIOLATION AND PROPOSED IMPOSITION OF CIVIL PENALTY -$2,750 (NRC Inspection Report No. 030-32210/97-01 and Investigation Report 4-97-060)|
Dear Mr. Moses:
This refers to the predecisional enforcement conference conducted in NRC's Region IV Office in Arlington, Texas on February 6, 1998, and to the supplemental information provided in your letter dated February 27, 1998. The conference was held to discuss the results of the inspection conducted on November 4 through December 30, 1997. Also, during this time, the NRC's Office of Investigation (OI) Region IV Field Office conducted an investigation, which concluded on February 23, 1998. The inspection and investigation were conducted following notification that a technologist admitted to deliberately falsifying certain required surveys. The results of our inspection were discussed with you on December 30, 1997, and are documented in the subject inspection report dated January 21, 1998.
Based on the information developed during the inspection and the information that you provided during the conference, the NRC has determined that a total of 22 violations of NRC requirements occurred. These violations are cited in the enclosed Notice of Violation and Proposed Imposition of Civil Penalty and the circumstances surrounding them are described in detail in the subject inspection report. These violations were discovered after a former Wood River Medical Center (WRMC) technologist, without prompting, informed hospital management that he prepared inaccurate NRC-required records for surveys that were never performed. As a result, WRMC contracted with a consultant to review its program, and then informed NRC of the falsification issue. While the consultant did not identify every violation, he did identify the more significant violations and determined that the cause of the violations was inadequate oversight by the radiation safety officer (RSO) and the hospital administration, including the radiation safety committee (RSC), to adequately supervise and review the radiation safety program.
In addition, the NRC has concluded that the preparation of the inaccurate NRC-required records of radiation surveys and dose calibrator checks involved deliberate misconduct, as the technologist realized what he was doing was wrong at the time he prepared the records. However, the lack of oversight by the RSO and hospital administration contributed to this violation. Specifically, the individual involved did not have formal training as a nuclear medicine technologist and, according to the individual, he was working up to 200 hours during a two week pay period. Moreover, on multiple occasions, he had indicated to hospital managers that he was just recording numbers, did not fully understand many of the tasks, and needed training in nuclear medicine technology. Increased oversight clearly should have been provided under those circumstances.
The more significant programmatic violations include failures to: (1) ensure that an individual under the supervision of an authorized user was adequately instructed, and to periodically review the supervised individual's use of licensed material and the records kept to reflect this use, (2) maintain management oversight and control of the radiation safety program, (3) ensure that the RSC met quarterly, (4) conduct quarterly reviews of occupational radiation doses of certain personnel, (5) perform annual reviews of the radiation safety program, (6) provide radiation safety refresher training, (7) notify the NRC of the discontinuation of an authorized user's duties, (8) seek amendment to the license prior to relocating an area of use, and (9) the failure to maintain records that were complete and accurate. We note that three of the cited violations are repetitive from the previous NRC inspection conducted on November 2, 1993.
These violations clearly indicate a deterioration of your radiation safety program. During the NRC's previous inspection (reference NRC Inspection Report 030-32210/93-01 dated November 17, 1993), the lack of familiarity with NRC requirements was discussed with the Radiation Safety Officer (RSO) who stated that additional training had been scheduled for the nuclear medicine staff and that an outside consultant would be retained to perform periodic reviews of the radiation safety program. Some training and reviews occurred but, as a result of a lack of oversight, these actions proved inadequate. Further, in October 1996, the Radiation Safety Committee (RSC) recognized that program deficiencies existed, including violations of NRC requirements previously identified and not corrected. Again, training and reviews by an outside consultant were scheduled and again, as a result of inadequate program oversight, the training and reviews were ineffective. During the conference, WRMC personnel confirmed that its problems resulted from a lack of familiarity with, and a lack of appreciation for the responsibilities of the RSO and the RSC under NRC regulations, and a failure of hospital administration to institute sufficient tracking systems or controls to ensure NRC regulations were met.
In arriving at this enforcement decision, we took into consideration that, individually, none of the violations resulted in a safety consequence to workers or members of the public. In addition, we recognized that WRMC identified the more serious issues, and began taking corrective actions prior to NRC involvement. However, given the lack of oversight by the RSO and the RSC over a period of several years, and the pervasiveness of the breakdown in your radiation safety program, 21 of 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 civil penalty with a base value 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. Based on the information provided during the conference, the NRC has determined that your corrective actions were sufficiently prompt and comprehensive to warrant Corrective Action credit. These actions included notifying the NRC of the falsification issue, contracting with a radiation safety specialist (a different consultant than previously used) to thoroughly review your program, ensuring sufficient training was provided to your nuclear medicine staff, hiring a certified nuclear medicine technologist, instituting measures to ensure the RSC conducts oversight activities as required, providing the RSO with additional training and support, providing additional oversight of the RSO, implementing additional tracking systems and controls to ensure required activities are performed at required frequencies, and continuing the contract with the radiation safety specialist to conduct audits and provide training.
While the NRC's civil penalty assessment process normally could have resulted in no civil penalty being proposed because of your good corrective actions, the NRC has determined that discretion to assess a penalty at a base value should be applied as provided for in Section VII.A.1 of the Enforcement Policy. The basis for the NRC's decision is the particularly poor licensee performance which contributed to the violations.
Therefore, to emphasize the importance of effective management oversight of licensed activities, I have been authorized, after consultation with the Director, Office of Enforcement, to issue the enclosed Notice of Violation and Proposed Imposition of Civil Penalty (Notice) in the base amount of $2,750 for the Severity Level III problem.
During the conference, members of your staff voiced disagreement with one of the apparent violations identified, and this disagreement was documented in your letter dated February 27, 1998. This apparent violation of 10 CFR 35.50(b)(4) involved records of dose calibrator geometry dependence which we contended did not indicate the range of volumes and volume configurations used. During the conference, your staff provided copies of the test records that indicated "syringe" and "vial." We agree that your record indicates the range of volumes and the volume configuration used. However, our review of this new information indicates that although a geometry dependence test was performed on August 10, 1995, the test was not performed using volumes and volume configurations that are commonly used, as the regulation requires. Specifically, the test record indicates the test was performed using a volume of up to 6 cubic centimeters (cc) for a syringe, which means the volume configuration used was (at least) a 10 cc syringe. This 10 cc syringe volume configuration is not the same volume configuration as a 3 cc syringe, which is used exclusively by WRMC. Additionally, our review found that the dose calibrator geometry dependency record did not include the model and serial number of the dose calibrator, as required. Therefore, violation 9 has been modified to reflect these conclusions.
The final violation identified in the attached Notice involves a failure to secure the NRC's consent in writing prior to changes in the control of the license in 1992 and 1997. This violation is cited separately at Severity Level IV.
NRC is corresponding separately with the individual involved in the preparation of inaccurate NRC-required records. You will receive a copy of that correspondence under separate cover.
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, and you may reference previously submitted correspondence. In addition to the specific responses required, we request that you supplement the information you provided at the conference regarding the continued use of your consultant. Specifically, please provide information regarding your plans for using the consultant (including the consultant's role in overseeing the radiation safety program and the consultant's role in participating in the program); the conditions, if any, under which you would reduce or terminate his services; anticipated time frames for using the consultant; and a commitment to inform the NRC about changes in the consultant's role, or the reasons why such a commitment is not warranted.
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).
Ellis W. Merschoff
Docket No. 030-32210
License No. 11-27355-01
Enclosure: Notice of Violation and Proposed Imposition of Civil Penalty
State of Idaho
Chairman, Board of Trustees
Health Care Authority
P. O. Box 86
Sun Valley, Idaho 83353
NOTICE OF VIOLATION
PROPOSED IMPOSITION OF CIVIL PENALTY
|Healthcare Authority dba
Wood River Medical Center
Sun Valley, Idaho
|Docket No. 030-32210
License No. 11-27355-01
During an NRC inspection completed on December 30, 1997, and an NRC investigation which concluded on February 23, 1998, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," NUREG-1600, the Nuclear Regulatory Commission 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. VIOLATIONS ASSESSED A CIVIL PENALTY
1. 10 CFR 35.25(a) requires, in part, that a licensee that permits the use of byproduct material under the supervision of an authorized user shall: (1) instruct a supervised individual in radiation safety principles appropriate to the individual's use of licensed materials, and (2) periodically review a supervised individual's use of licensed material and the records kept to reflect this use.
Contrary to the above, as of December 5, 1997, the licensee did not instruct a supervised individual in radiation safety principles appropriate to the individual's use of licensed materials, and the licensee did not periodically review a supervised individual's use of licensed material and the records kept to reflect this use. (01013)
2. 10 CFR 35.21(a) requires that the licensee, through the radiation safety officer (RSO), ensure that radiation safety activities are being performed in accordance with Commission regulations, license conditions, and the licensee's radiation safety procedures.
Contrary to the above, as of November 5, 1997, the licensee through the RSO, failed to ensure that radiation safety activities were being performed in accordance with Commission regulations, license conditions, and the licensee's radiation safety procedures. Specifically, the inspection identified numerous violations indicating a breakdown in the licensee's oversight and control of its radiation safety program, and the RSO admitted to providing little oversight of the program. (01023)
3. 10 CFR 35.22(a)(2) requires that the Radiation Safety Committee (RSC) meet at least quarterly.
Contrary to the above, the licensee's RSC failed to meet at least quarterly from January 1994 through December 1997. Specifically, the RSC met only twice in 1994, once in 1995, once in 1996, and twice in 1997. (01033)
4. 10 CFR 35.22(b)(4) requires that to oversee the use of licensed material, the RSC must review quarterly, with the assistance of the RSO, a summary of the occupational radiation dose records of all personnel working with byproduct material.
Contrary to the above, for years 1994-1996, the licensee's Radiation Safety Committee failed to review a summary of the occupational radiation dose records of all personnel working with licensed material. No reviews were performed during these years. (01043)
5. 10 CFR 20.1101 requires that the licensee review annually the radiation safety program.
Contrary to the above, the licensee failed to review the radiation safety program for the years 1994-1996. (01053)
This is a repeat violation.
6. License Condition 15 requires, in part, that licensed material be used in accordance with statements, representations, and procedures contained in the application dated September 25, 1992. The licensee's commitment to provide training for radiation workers is specified in item 8, Training For Individuals Working In Or Frequenting Restricted Area, of that application. In item 8, the licensee committed to implementing the model training program contained in Appendix A to Regulatory Guide 10.8, Revision 2, which requires, in part, that the licensee provide annual refresher training for occupationally exposed workers and ancillary personnel.
Contrary to the above, the licensee failed to provide refresher training for occupationally exposed workers in nuclear medicine for the years 1994 -1996. (01063)
7. 10 CFR 35.50(b)(3) requires, in part, that a licensee test each dose calibrator for linearity at least quarterly.
Contrary to the above, for years 1994-1996, the licensee failed to perform quarterly dose calibrator linearity tests. Specifically, during this time period, 7 quarterly linearity tests were performed and 5 were not performed. (01073)
This is a repeat violation.
8. 10 CFR 35.50(b)(2) requires, in part, that the licensee test each dose calibrator for accuracy by assaying at least two sealed sources whose activity the manufacturer has determined within 5 percent of its stated activity. 10 CFR 35.50(e) requires, in part, a record for each required test be retained, and that for the test required by paragraph (b)(2) above, the record contain the model and serial number of the dose calibrator, the model and serial number of each source used, the identity of the radionuclide contained in the source and its activity, the date of the test, the results of the test, and the identity of the individual performing the test.
Contrary to the above, as of November 5, 1997, the licensee had failed to use at least two sealed sources whose activity the manufacturer had determined within 5 percent of the stated activity to test the dose calibrator for accuracy, and failed to include the identity of the individual performing the accuracy tests on the accuracy test record. Specifically, the licensee had used only one sealed source to perform an accuracy test on March 16, 1994, and the licensee failed to include the name of the individual who performed an accuracy test on September 15, 1995, to comply with records maintenance requirements of 10 CFR 35.50(e). (01083)
9. 10 CFR 35.50(b)(4) requires, in part, that a licensee test each dose calibrator for geometry dependence upon installation over the range of volumes and volume configurations for which it will be used. 10 CFR 35.50(e)(4) requires, in part, that the records required in paragraph (b)(4) of this section must include the model and serial number of the dose calibrator, and the configuration of the source measured.
Contrary to the above, as of November 5, 1997, the licensee had failed to test a dose calibrator for geometry dependence over the range of volumes and volume configurations for which it was used. Specifically, the geometry dependence test record indicated the test was performed using a volume and configuration other than that which was routinely used for radiopharmaceuticals. Additionally, the dose calibrator geometry dependency record did not include the model and serial number of the dose calibrator. (01093)
10. 10 CFR 35.70(a) requires that a licensee survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals are routinely prepared for use or administered.
Contrary to the above, on 67 days between January 1 and October 28, 1997, the licensee failed to survey with a radiation detection survey instrument at the end of each day of use all areas where radiopharmaceuticals were routinely prepared for use or administered. (01103)
11. 10 CFR 35.70(b) requires that a licensee survey with a radiation detection survey instrument at least once each week all areas where radiopharmaceuticals or radiopharmaceutical waste is stored.
Contrary to the above, for the period December 1991 through October 1997, the licensee failed to survey with a radiation survey instrument at least once each week the basement room used to store radioactive waste and spent generators. Specifically, no surveys were performed during this timeframe. (10113)
12. 10 CFR 35.59(b)(2) requires, in part, that a licensee in possession of a sealed source test the source for leakage at intervals not to exceed 6 months or at other intervals approved by the Commission or Agreement State.
Contrary to the above, between calendar years 1994 -1996, and the first 6 months of 1997, the licensee had not leak tested a barium-133 source, and between calendar years 1994-1995, and the first 6 months of 1997, the licensee had not leak tested a cesium-137 source. (01123)
13. 10 CFR 35.59(d) requires, in part, that a licensee must retain leak tests records for 5 years, and these leak tests records must contain the signature of the RSO.
Contrary to the above, the licensee failed to include the signature of the RSO on the leak test record dated November 22, 1996. (01133)
14. 10 CFR 35.59(g) requires, in part, that a licensee in possession of a sealed source must conduct a quarterly physical inventory of all sources in its possession.
Contrary to the above, the licensee failed to conduct quarterly physical inventories of sealed sources from January 1992 to October 1997. Specifically, the licensee had conducted physical inventories at 12-month intervals, a period in excess of 3 months. (01143)
15. 10 CFR 20.1906(b) requires, in part, that a licensee monitor the external surfaces of a package labeled with Radioactive White 1, Yellow II, or Yellow III label for: (1) radioactive contamination, unless the package contains only radioactive material in the form of a gas or in special form as defined in 10 CFR 71.4; and (2) radiation levels, unless the package contains quantities of radioactive material that are less than or equal to the Type A quantity, as defined in 10 CFR 71.4 and Appendix A to Part 71.
Contrary to the above, the licensee failed to monitor for contamination seven packages received between November 9, 1996, and October 28, 1997, which contained radioactive material and were labeled Radioactive White I, Yellow II, or Yellow III. (01153)
16. 10 CFR 35.53(c)(5) requires that a licensee retain records of the measurement of radiopharmaceutical dosages for 3 years and that the record contain the initials of the individual who made the record.
Contrary to the above, the licensee's radiopharmaceutical dose administration records for all patient dosages administered between March 17, 1995, and October 28, 1997, failed to contain the initials of the individuals who made the records. (01163)
17. 10 CFR 35.92(b) requires that a licensee retain for three years a record of each disposal of byproduct material permitted under 10 CFR 35.92(a), and that the record include the date of the disposal, the date on which the byproduct material was placed in storage, the radionuclide disposed, the survey instrument used, the background dose rate, the dose rate measured at the surface of each waste container, and the name of the individual who performed the disposal.
Contrary to the above, for the period between March 17, 1995, and October 28, 1997, the licensee failed to include in byproduct material disposal records: (1) the survey instrument used to perform the final disposal survey, (2) the background dose rate, and (3) the actual radiation exposure reading measured at the surface of each waste container prior to its disposal in normal trash. (01173)
18. 10 CFR 19.13(b) requires that a licensee advise each worker annually of the worker's dose as shown in records maintained by the licensee pursuant to the provisions of 10 CFR 20.2106.
Contrary to the above, the licensee failed to advise each worker of the worker's dose for calendar years 1994 -1996. (01183)
19. 10 CFR 35.14(b)(1) requires, in part, that a licensee notify the NRC by letter within 30 days when an authorized user permanently discontinues performance of duties under the license.
Contrary to the above, in 1995, the licensee failed to notify the NRC by letter within 30 days when an authorized user permanently discontinued performance of duties under the license. (01193)
20. 10 CFR 35.13(e) requires that a licensee apply for and must receive a license amendment before it adds to or changes the areas of use or address or addresses of use identified in the application or on the license.
Contrary to the above, in March 1994, the licensee failed to apply for and receive a license amendment prior to changing the area where radioactive material was used for diagnostic nuclear medicine from the basement of the hospital to the main floor. (01203)
21. 10 CFR 30.9(a) requires, 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.
Contrary to the above, from about February 1993 through October 1997, information required by the Commission's regulations was not maintained complete and accurate in all material respects. Specifically, records of routine weekly wipe test surveys, daily area surveys, and daily dose calibrator checks were periodically prepared for occasions when the surveys/checks had not actually been performed. This information is material because these records are NRC-required records. (01213)
These violations represent a Severity Level III problem (Supplement VI).
Civil Penalty $2,750
B. VIOLATION NOT ASSESSED A CIVIL PENALTY
10 CFR 30.34(b) specifies that no license issued or granted pursuant to the regulations in this part and Parts 31 through 39, nor any right under a license shall be transferred, assigned or in any manner disposed of either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Commission shall, after securing full information, find that the transfer is in accordance with the provisions of the Atomic Energy Act of 1954 as amended, and shall give its consent in writing.
Contrary to the above, the licensee failed to secure the NRC's consent in writing prior to two changes in control of licensed activities. Specifically, in 1992, there was a change in control of the license as a result of the creation of a new entity, Healthcare Partnership, and in 1997 there was another change in control of the license as a result of the formation of the Healthcare Authority, a joint city-county Healthcare Authority created by Blaine County and the City of Sun Valley, Idaho, without first providing NRC an opportunity to determine whether the transfers were in accordance with the provisions of the Act and to consent in writing to the transfers. (02014)
This is a Severity Level IV violation (Supplement VI).
Pursuant to the provisions of 10 CFR 2.201, Wood River Medical Center 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 Penalty (Notice). This reply should be clearly marked as a "Reply to a Notice of Violation" 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. 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. Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response shall be submitted under oath or affirmation.
Within the same time as provided for the response required above under 10 CFR 2.201, the licensee may pay the civil penalty by letter addressed to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, with a check, draft, money order, or electronic transfer payable to the Treasurer of the United States in the amount of the civil penalty proposed above, or the cumulative amount of the civil penalties if more than one civil penalty is proposed, or may protest imposition of the civil penalty 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 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.B.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 234c of the Act, 42 U.S.C. 2282c.
The response noted above (Reply to Notice of Violation, letter with payment of civil penalty, and Answer to a Notice of Violation) should be addressed to: James Lieberman, 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 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 27th day of April 1998