IR 07100104/2012030
| ML20198R332 | |
| Person / Time | |
|---|---|
| Site: | 07100104, 03032210 |
| Issue date: | 01/21/1998 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20198R321 | List: |
| References | |
| 30-32210-97-01, 30-32210-97-1, NUDOCS 9801230283 | |
| Download: ML20198R332 (21) | |
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ENCLOSURE 1 U.S. NUCLEAR REGULATORY COMMISSION
REGION IV
Docket No.:
030-32210 License No.:
11 27355 01 Report No.:
030-32210/97-01 Licensee:
Wood River Medical Center Facility:
Wood River Medical Center Sun Valley Location Location:
Sun Valley, Idaho Dates:
November 4 through December 30,1907 Inspector:
Richard A. Leonardi, Jr.
Radiation Specialist Approved By:
D. Blair Spitzberg, Ph.D., Chief Nuclear Materials Inspection and Fuel Cycle / Decommissioning Branch Division of Nuclear Materials Safety Attachments:
Supplemental Inspection Information 1-e
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EXECUTIVE SUMMARY Wood River Medical Center Sun Valley Location, Sun Valley, Idaho NRC Inspection Report No. 030-32210/97-01 This inspection was conducted to review the radiation safety activities associated with a small nuclear medicine program.
Proaram Overview This is a small nuclear medicine program licensed for use of byproduct material for
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uptake, dilution, and excretion studies, and for imaging and localization studies as specified in 10 CFR 35.100 and 35.200. The program supports an orthopedic surgery program.
Manaaement Oraanization and Trainina An apparent violation of 10_ CFR 35.25(a) Involving the failure of the radiation safety
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officer (RSO) to properly supervise an individual working under his supervision was-identified (Section 2).
Numerous apparent violations indicating a significant programmatic breakdown in the
licensee's oversight and control of the radiation safety program were identified.
Several of these apparent violations had beon identified by the licensee through a consulting physicist's audit conducted the week prior to NRC's inspection. The licensee's failura to ensure, through the RSO, that activities were being performed as required was identified as an apparent violation of 10 CFR 35.21 (a) (Section 2).
An apparent violation of 10 CFR 35.22(a)(2) involving the failure to conduct radiation
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safety committee (RSC) meetings at quarterly intervals v.as identified (Section 2).
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An apparent violation of 10 CFR 35.22(b)(4) involving the RSC's failure to mview
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quarterly, with the assistance of the RSO, a summary of the occupational radiation dose records of all personnel working with licensed material was identified (Section 2).
An apparent violation of 10 CFR 35.22(b)(6) involving the failure of the RSC to review
annually, with the assistance of the RSO, the radiation safety program was identified
' (Section 2). A violation of this requirement was identified during the previous NRC inspection conducted on November 2,1933.'
An apparent violation of License Condition 15 involving the failure to provide annual-
radiation safety refresher training for users of licensed material was identified (Section 2).
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-3-Doss Calibrator Usp_
An apparent violation of 10 CFR 35.50(b)(3) involving the failure to test the dose
calibrator for linearity at east quarterly for 8 quarters between 19%1997 was identified (Section 3). A violation of this requirement was identified during the previous NRC inspectior of November 2,1993.
An apparent violation af 10 CFR 35.50(b)(2) and 35.50(e)(2) involving the failure to
use at least two se:aled sources containing different radionuclides for the accuracy test performed on the dose calibmtor on March 16,1994, and the failure to include the identit/ of the individual performing the accuracy test on September 15,1995, in records maintained by the licensee was identified (Section 3).
An apparent violailon of 10 CFR 35.50(e)(4) involving the failure to identify the
configuration of the source used to test geometry dependence of the dose calibiator on August 10,1995, was identitled (Section 3).
Radiation Monitorina Proaram An apparent violation of 10 CFR 35.70(a) involving the failure to perform ambient
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radiation area surveys at the end of each day of use in all areas where radiopharmaceuticals were routinely prepared or used was identified. Based on the results of the inspection, it appeared that required surveys were not performed on at least 67 days between January 1 and October 28,1997 (Section 4).
An apparent violation of 35.70(b) !nvolving the failure to perform weekly ambient
radiation area surveys in all areas where radiopharmaceuticals or radiopharmaceutical waste were stored was identified (Section 4).
Leak Test and Inventory Control An apparent violation of 35.59(b)(2) involving the failure to perform leak tests on two
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sealed sources at 6-month intervals from 1994-1996, and during the first 6 months of 1997 was identified (Section 5). A violation of this requirement was identified during the previous NRC inspection conducted on November 2,1993.
An apparent violation of 10 CFR 35.59(d) invciving the failure to include the signature
of the radiation safety officer on a leak test fecord was identified (Section 5).
An apparent violation of 10 CFR 35.59(g) involving the failure to conduct physical
inventories of all sealed sources at quarterly intervals for calendar years 1993-1997, and the failure to include the signature of the radiation safety officer on three inventory records was identified (Sectior 5).
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4-Materials Receipt and Preparation An apparent violation of 10 CFR 20.1906(b)(1) involving the failure to perform seven
radioactive package receipt surveys between November 9,1996, and October 28, 1997, *.vas identified (Section 6).
An apparent violation of 10 CFR 35.53(c)(5) involving the failure to maintain a record
of the individual who measured and recorded each patient dose between January 6 and October 28,1997, was identified (Section 6).
Waste Manaoement An apparent violation of 10 CFR 35.92(b) involving the failure to include various
required information on radioactive waste disposal records between March 17,1995, and October 28,1997, was identified (Section 7).
Licensee Notifications An apparent violation of 10 CFR 19.13(b) involving the failure to advise each worker
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annually of the worker's dose as shown in records maintained by the licensee pursuant to 10 CFR 20.2106 was identified (Section 6).
An apparent violation of 10 CFR 35.14(b)(1) involving the failure to notify the NRC by
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letter within thirty days when an authorized user permanently discontinued performance of duties under the license was identified (Section 8).
An apparent violation of 10 CFR 35.13(e) involving the failure to have applied for and
received a license amendment before relocating an area of use of licensed material was identified (Section 8).
An apparent violation of 10 CFR 30.34(b) involving the failure to have received the
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NRC's consent prior to the transfer of control of the license was identified (Section 8).
Completeness and Accuracy of Information An apparer t violation of 10 CFR 30.9 involving the failure to have maintained
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information that was complete and accurate in all material respects was identified (Section 9).
Causes & Contributino Factors and Licensee Corrective Actions The inspection determined that the licensee had implemented corrective actions in
response to apparent violations identified by the licensee's consultant during the consultant's radiation safety program review performed on October 28 and 30,1997.
This review appeared to be effective in identifying numerous program weaknesses and their root causes, and recommendations for corrective measures were provided to the licensee (Section 10).
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5, Report Details
Program Overview (87100)
Wood River Medical Center (WRMC) is authorized under a limited medical program license for use of byproduct material for uptake, dilution, and excretion studies, and for imaging and localization stud:es as specified in 10 CFR 35.100 and 35.200. The nuclear medicine facilities consisted of a single imaging room and a separate radioactive material storage room. The nuclear medicine program was smallin size and scope in that a single nuclear medicine technologist performed approximately 170 nuclear procedures in an 8-month period. The licensee performed no radiopharmaceutical therapy or brachytherapy and thus was not required to maintain a quality management program. WRMC primarily used technetium-99m labeled radiopharmaceuticals to detect pulmonary embolism and bone fractures in support of an orthopedic surgery program, as well as an occasional thyroid uptake and scan.
The licensee received a 2.0 or 1.5 curie molybdenum-99 generator every 2 weeks as a source of sodium pertechnetate (Tc-99m) for making up radiopharmaceuticals.
WRMC possessed a single dose calibrator, sealed sources used to perform required calibrations on the dose calibrator, and two survey instruments for radiation monitoring.
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Management Organization and Training (87100)
2.1 Inspection Scope This portion of the inspection included interviews with licensee personnel, a review of licensee records, and observation of licensee activities to determine the effectiveness of the licensee's management and control of licensed activities.
2.2 Observations and Findinas WRMC was a small nuclear medicine program with only a single nuclear medicine technologist and two active radiologists performing an average of 3-5 nuclear medicine procedures a week. Based on a review of a radiation safety program audit performed by the licensee's consulting physicist on October 28 and 30,1997, the inspector's interviews, and a review of licensee records, the inspector concluded that neither WRMC management nor the GSO had exercised adequate oversight and control of the radiation safety program as evidenced by the number of apparent violations identified during the inspection.
During discussions with licensee management, the inspector determined that prior to October 1997, licensee management appeared unaware that significant program weaknesses existed. The licensee's management was first alerted to these weaknesses following a precipitating incident involving a technician's admission of having falsified survey records (see Section 9.2) and the subsequent radiation
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-6-program audit which was performed by an outside consultant. The licensee disclosed that although the consulting physicist had provided limited consulting services in the past, this was the first program audit performed at the licensee's request. The consultant's radiation safety program audit identified numerous apparent violations of NRC requirements, license conditions, and licensee radiation safety procedures, included in the apparent violations identified by the consulting physicist were three repeat apparent violations from the previous NRC inspection conducted November 2, 1993.
The consultant's program audit (hereafter called consultant's report) also identified inadequate oversight by licensee management and the radiation safety officer as root causes for the radiation safety program taakdown. Several of the apparent violations identified in this report were initially identified by the licensee's consultant and are so noted.
10 CFR 35.25(a) requires, in part, that an authorized user must: (1) instruct a supervised individual in radiction f.afety principles appropriate to the individual's use of licensed materials, (2) require a supervised individual to follow the instructions of the supervising authorized user, (3) require a supervised individual to follow the wiitten radiation safety procedures established by the license and NRC regulations, and (4) periodically review a supervised individual's use of licensed material and the records kept to reflect this use. During an interview with WRMC's RSO after the onsite portion of the inspection was completed, the inspector determined that the RSO had relied upon the technologist currently working in nuclear medicine and the chief radiology technologist to keep him apprised as to any radiation safety program concems. Further, the RSO acknowledged that he had not directly or indirectly supervised or taken an active role in the daily duties associated with WRMC's licensed activities. The RSO and primary authorized user disclosed that he had provided some initial guidance to the technologist regarding the clinical aspects of the technologist's job duties by demonstrating to the technologist the image quality he expected from the nuclear medicine procedures performed. However, the RSO indicated that he had not routinely reviewed the technologist's activities since he believed that the technologist had been trained in the technical aspects of nuclear medicine and did not require his periodic review. The failure of the RSO to properly supervise an individual working under his supervision during the performance of nuclear medicine activities was identified as an apparent violation 10 CFR 35.25(a)
(030-32210/97-01).
The inspector determined that since the previous NRC inspection of November 1993, WRMC had experienced tumover in personnel assigned nuclear medicine duties.
The inspector determined that four WRMC radiologic technologists had assumed nuclear medicine duties and responsibilities since the NRC inspection of November 1993. The inspection disclosed that none of the four radiologic technotcgists had received formal training in nuclear medicine technology prior to assuming nuclear medicine duties. The inspector noted that each of the four radiologic technologists who assumed nuclear medicine duties during the time frame November 1993 through
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October 1997 had been trained by on-the-job training provided by the previous radiologic technologist.
10 CFR 35.21(a) requires that the licensee through the RSO ensure that radiation safety activities are being performed in accordance with Commission regulations, license conditions, and the licensee's radiation safety procedures, it is esser;tial that strong licenseo management controls and oversight exist to ensure that licensed activities are conducted properly. NRC holds the licensee-appointed RSO responsible for implementing the radiation safety program. The licensee, through the RSO, must ensure that radiation safety activities are being performed in accordance with approved procedures and regulatory requirements in the daily operation of the licensee's licensed activities. Based on a review of the consultant's report, and independent verification by the inspector, numerous apparent violations of NRC requirements were identified, including three issues which were cited as violations during the previous inspection of November 2,1993. The failure of the licensee through the RSO to ensure that radiation safety activities were being performed in accordance with Commistion regulations, license conditions, and licenseo's radiation safety procedures was identified as an apparent violation of 10 CFR 35.21(a)
(030 32210/97-02). This apparent violation was also identified by the licensee's consultant.
10 CFR 35.22(a)(2) requires that the licensee's RSC meet at least quarterly. Based on a review of the consultant's report and independent verification by the inspector, the inspector determined that the licensee's RSC had failed to meet during eight calendar quarters in calendar years 1994 through 1997. During discussions with licensee personnel, they indicated that not all RSC members were available for all needed RSC meetings, and sometimes radiology workloads would not permit scheduled RSC meetings. The failure of the licensee's RSC to meet quarterly was identified as an apparent violation of 10 CFR 35.22(a)(2) (030-32210/97-03). This apparent violation was also identified by the licensee's consultant.
10 CFR 35.22(b)(4) requires that the licensee's RSC, with the assistance of the RSO, review quarterly a summary of the occupational radiation dose records of all personnel working with licensed material. The review of the licensee's RSC minutes indicated that the RSC had not reviewed quarterly a summary of the occupational radiation dose records (ALARA Review) of all personnel working with licensed material for calendar years 1994-1996. The radiology manager confirmed during a interview with the inspector that the RSC failed to review quarterly a summary of radiation dose records of all personnel working with licensed material. The failure of the licensee to conduct quarterly ALARA reviews was identified as an apparent violation of 10 CFR 35.22(b)(4) (030-32210/97-04).
10 CFR 20.1101(c) requires that the licensee review annually the radiation safety program. The inspector determined during the review of the licensee's RSC minutes that the licensee had failed to review the licensee's radiation safety program for calendar years 1994-1996. The failure of the licensee to perform annual reviews of the radiation safety program was identified as an apparent vio!ation of
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-8-10 CFR 20.1101(c) (030-32210/97-05). This apparent violation was identified by the licensee's consultant. A violation of this requirement was identified during the previous inspection conducted November 2,1993.
License Condition 15 requires, in part, that the licensee conduct its program in accordance with statements, representations, and procedures contained in license application dated September 25,1992. The licensee's commitment to provide training for radiation workers k, specified in item 8, Training For Individuals Working in or Frequenting Restricted Area, of that application. In item 8, the licensee committed to implement the model training program contained in Appendix A to Regulatory Gulds 10.8, Revision 2, which requires, in part, that the licensee provide annual refresher training. A review of the licensee's training records indicated that the licensee failed to provide radiation safety refresher training for nuclear medicine personnel for calendar years 1994 1996. The failure of the licensee to provide refresher training for nuclear medicine personnel was identified as an apparent violation of License Condition 15 (030-3221/97-06). This apparent violation was identified by the licensee's consultant.
2.3 Conckisip.ng Six apparent violations of NRC requirements were identified, including failures of:
(1) the RSO to supervise individuals working with licensed materials under his supervision (2) the RSO to ensura that radiation safety activities were being performed as required, (3) the RSC to conduct radiation safety committee meetings at least quarterly, (4) the RSC to conduct quarterly ALARA reviews, (5) the RSC to conduct annual radiation safety program reviews, cnd (6) the licensee to provide annual radiation safety refresher training. The inspector concluded that neither WRMC management nor the RSO had exercised adequate oversight and control of the radiation safety program as evidenced by the apparent violations discussed above. Notwithstanding the apparent breakdown in management oversight and control as discussed above, a review of the licensee's use of licensed material in the performance of diagnostic nuclear medicine appeared not to have compromised patient care.
Dose Calibrator Use (87100,)
3.1 Inspection Scope This portion of the inspection included interviews with licensee personnel and a review of licensee records pertaining to the use of the dose calibrator to assay patient doses.
3.2 Qbservations and Findinas The licensee used a single Capintec Model CRC-7 dose calibrator and possessed two sealed sounms for calibrator accuracy testing. During the review of licensee records, the inspectu jetermined that the dose calibrator had been tested for accuracy, linearity, and geometry by several different individuals over the past 4 years. A review
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of the dose calibrator constancy checks indicated that the checks had been performed as required using a cesium 137 sealed source.
10 CFR 35.50(b)(3) requires that the licensee perform quarterly dose calibrator linearity tests. A review of the licensee's quarterly linearity tests indicated that several different individuals had performed the tests over the past 4 years. Based on a review of the consultant's report and independent verification by the inspector, the inspector determined that the licensee failed to perform eight quarterly linearity tests during calendar years 1994-1997. Licensee personnel indicated that they believed that some of the linearity tests had been performed; however, no rmords could be found. The failure of the licensee to perform quarterly dose calibrator linearity tests for eight quarters was identified as an apparent violation of 10 CFR 35.50(b)(3)
(030-32210/97-07). This apparent violation was identified by the licensee's consultant. This was a repeat apparent violation from the previous inspection of November 2,1993.
10 CFR 35.50(b)(2) and 35.50(o)(2) require that two different sealed sources be used to perform dose calibrator accuracy tests and that the individual's name performing the accuracy tests be recorded. The licensee possessed two sealed sources for use in pmforming the dose calibrator accuracy tests. Cesium-137 (Serial No. S356012-040) and barium-133 (Serial No. S356306-061) sealed sources were available to perform accuracy tests. A review of the dose calibrator accuracy tests revealed that the licensee had used only one sealed source to perform an accuracy test performed on March 16,1994, in addition, the licensee failed to include the name of the individual performing an accuracy test in records documenting a test performed on September 15,1995. The failure of the licensee to use two different sealed sources and include the individual's name performing the accuracy tests in associated records on dates indicated was identified as an apparent violation of 10 CFR 35.50(b)(2) and 35.50(e)(2) respectively (030-32210/97-08).
10 CFR 35.50(e)(4) requires that records of geometry dependence tests include the source configuration. A review of the licensee's geometry test records for the dose calibrator revealed that the licensee failed to indicate the configuration of the source used to test the dose calibrator for geometry dependence on August 10,1995. The licensee's radiology director indicated that she was not aware of this requirement.
The failure of the licensee to identify the cource configuration used to test the dose calibrator teometry dependence was idenufied as an apparent violation of 10 CFR 35 50(e)(4) (030 32210/97-09).
During diset.ssions with licensee management and radiology personnel, the inspector determined 11at the licensee's failure to perform the required tests and record the necessary int )rmation could be attributed to the licensee's lack of familiarity with the requirements n 10 CFR 35.50 and the misinformation provided by an outside practicing nucliar medicine technologis ___
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Conclusions F
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i Three apparent violations of NRC requirements were identified, including
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failures to: _ (1)' perform dose calibrator linearity tests as required, (2) use two
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sealed sources to perform dose calibrator accuracy tests as required, and (3)
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identify the source cor,7 uration used to test the dose calibrator geometry i
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dependence as required.
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Radiation Monitoring Program (87100)
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- 4.1 IDsoection Scooe
l This portion of the inspection included interviews with licensee personnel and a review of licensee records pertaining to the radiation monitoring program.
4.2 Observations and Findinos '
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10 CFR 35.70(a) and 35.70(b) require that the licensee perform area surveys for ambient radiation levels on each day of use in areas where licensed materials are
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prepared or used, and wsekly in areas where licensed materials are stored. The
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inspector determined that the licensee possessed and used two survey instruments to o
perform area radiation surveys. One of the survey instruments (end-window.
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Geiger-Mueller survey instrument) was used to count area wipes for removabMs
contamination. Based on a review of the consultant's report and independent verification by the inspector, which included acknowledgement by licensee personnel that some area surveys were not performed, it was determined that the licensee failed to perform area radiation surveys for 67 days in areas where licensed matarial had been prepared or used between January 1 and October 28,1997. The failure of the licensee to have performed area radiation surveys on days of use in areas where
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licensed material had been prepared or used was identified as an apparent violation.
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of 10 CFR 35.70(a) (030-32210/97-10), This apparent violation was identified by the'
licensee's consultant.
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Based on a review of the consultant's report and independent verification by the
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inspector, area ambient radiation survey records for the basement room used to store P
radioactive waste and spent molybdenum-99 generators indicated that the licensee had failed to perform surveys on a weekly basis as required. During discussions with
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the licensee's radiology director, she indicated that she assumed that.the required-
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surveys had been performed. The failure of the licensee to perform weekly ambient-radiation area surveys in all areas where radiopharmaceuticals or radiopharmaceutical waste had been stored was identified as an apparent violation of 10 CSR 35.70(b)
.(030-32210/97-11). This apparent _ violation wss identified by the licensee's -
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11-i 4.3 Conclusions Two apparent violations of NRC requirements were identified involving: (1) the failure to perform daily ambient radiation surveys in areas where licensed material was prepared or used, and (2) failure to perform tne same surveys on a weekly basis in areas where licensed material was stored. The inspection identified the failure of a technologist to routinely perform the required surveys and the lack of familiarity with re0ulatory requirements by radiology department
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personnel as contributing factors to the survey deficiencies described above.
Leak Test and Inventory Control (87100)
5.1 Inspection Scope This portion of the inspection included interviews with licensee personnel and a review of licensee records involving the sealed source leak test and inventory program.
5.2 Observations and Findinas j
10 CFR 35.59(a)(2), 35.59(d), and 35.59(g) require that: (1) sealed source leak tests be performed quarterly, (2) the RSO's signature appear on the leak test record, and
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(3) sealed source inventorirs be performed en a quarterly interval. Based on a review of the consultant's report and independent verification by the inspector, it was determined that the licensee failed to perform leak tests at the required intervals for two sealed sources (barium-133, Serial No. S358006-061 and cesium-137. Serial l
No. S356012-040). The barium-133 source had not been leak tested during ca'endar years 1994-1996, and the fir:t 6 months of 1997. The cesium-137 source had not been leak tested for calendar years 1994 1995, and the first 6 months of 1997. It was further determined that the licensee was using misleading written guidance that had been provided by an outside individual that indicated that leak tests of sealed sources were to be performed on an annual frequency. The failure of the licensee to perform leak tests on two sealed sources on 6-month intervals was identified as an apparent violation of 10 CFR 35.59(a)(2) (030-32210/97-12). This apparent violation was identified by the licensee's consultant. This was an apparent repeal violation from the previous inspection conducted November 2,1993.
During the review of leak test records, the inspector identified the licensee's failure to include the RSO's signature on the leak test record dated November 22,1996, for the cesium-137 source discusJed above. The failure of the licensee to include the sigr4ature of the RSO on leak test records was identified as an apparent violation of 10 CFR 35.59(d) (030-32210/97-13).
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Based on a review of the consultant's repoit, independent verification by the inspector, and a review of records associated with the licensee's quarterly sealed source inventories, the inspector verified that the licensee failed to conduct physical inventories at quarterly intervals for calendar years 1993-1997 ana to include the signature of the RSO on two inventory records dated October 1996 and September
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1995. The licensee's consultant determined that the licensee was using misleading
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written guidance that had been provided by an outside individual which indicated that physical sealed source inventories were to be conducted on an annual frequency.
The failure of the licensee to conduct physicalinventories of sealed scurces at quarterly intervals was identified as an apparent violation of 10 CFR 35.59(g) (030-32210/97 14). This apparent violation was identified by the licensee's consultant.
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i 5.3 Conclusions Three apparent violations of NRC requirements were identified, including the failures to: (1) perform leak test on sealed sources on a 6 month interval, (2) include the signature of the RSO on a leak test records, and (3) conduct physical inventories of all sealed sources on a quarterly Interval. The inspection concluded that the licensee's use of misleading information provided by an outside individual and the lack of familiarity of NRC requirements appeared to contribute to the apparent violations discussed above,
Materials Receipt and Preparation (87100)
8.1 Inspection Scope
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This portion of the inspection included interviews with licensee personnel and a review of licensee records pertaining to the receipt, preparation, and administration of licensed materials.
6.2 Observations and Findinas 10 CFR 20.1906(a)(1) requires that package receipt surveys be performed. Based on a review of the consultant's report and independent verification by the inspector, it we determined that the licenseo had failed to perform seven package receipt surveys
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for licensed material received between November 9,1996, and October 28,1997.
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During discussions with licensee personnel, the inspector determined that licensee management and radiology department personnel were not aware that the package receipt surveys described above had not been performed. The failure of the licensee to perform package receipt surveys for licensed material was identified as an apparent violation of 10 CFR 20.1906(a)(1) (030 32210/9715). This apparent violation wey identified by the licensee's consultant.
10 CFR 35.53(c)(5) requires that the idontity of the person documenting the measurement of cach patient dose be recorded. The inspector reviewed the licensee's procedures for the administration and documentation of radiopharmaceuticals administered to patients. During the records review, the
inspector determined that the name of the individual vtho documented the
- measurement of patient dosages had not been identified in rccords for all patient doses administered bet veen March 17,1995, and October 28,1997. During discussions with licensee management and radiology department personnel, the inspector determined that neither management nor radiology department personnel a-,y
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were aware of this omission from the records. The failure of the licensee to document the identity of the individual who made a record of each dose measurement was identified as an apparent violation of 10 CFR 35.53(c)(5) (030 32210/9716).
6.3 C20plusions Two apparent violations of NRC requirements were identified including the failure of the licensee to perform package receipt surveys and the failure to document the identity of the person making records of patient doso measurements. The inspection concluded that both management and radiology department personnel were unaware of the deficiencies described above. Additionally, the RSO had not reviewed the technologist's record keeping and documentation activities, which might have identified these deficiencies.
Waste Management (87100)
7.1 10.12tglion Scope This portion of the inspection included interviews with licensee personnel and a review of licensee records pertaining to the licensee's radioactive waste management program.
7.2 Observations and Findin21
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10 CFR 35.92 requires specific information to be included in radioactive waste disposal records. The inspector noted that the licensee used the nuclear medicine hot lab for the short-term storage of radioactive waste. The inspector further determined that the licensee used a basement storage room for long term storage of waste that had been transferred from the hot lab for final disposition. During the review of the licensee's radioactive waste processing records contained in the radioactive waste logbook, the inspector determined that the disposal records did not include: (1) the unique identification of the survey instrument used to perform the final disposal survey, (2) the background radiation exposure reading at the time each wasto container was surveyed, and (3) the actual radiation expot.ure reading measured on the surface of each waste container prior to its disposal in normal trash for the period between March 17,1995 and October 28,1997. During discussions with radiology department personnel, the inspector determined that the current and previous technologists had not been familiar with NRC requirements relating to disposal of radioactive waste, since none of the currerd and past technologists had received formel training in nuclear medicine and associated regulatory requirements. The failure of the licensee to include required information on the radioactive waste
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disposal records was identified as an apparent violation of 10 CFR 35.92.(b)
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14-7.3 Conclusion One apparent violation of NRC requirements was identified for the licensee's failure to include required information on radioactive waste disposal records. The apparent lack of formal nuclear medicine training and familiaffy with NRC requirements contributed to the apparent violation.
Licensee Notifications and Reports (87100)
8.1 Insoection Scong This portion of the inspection included intervie.vs with licensee personnel, observations of licensee activities, and review of licensee records to determine if the licensee provided required notifications and reports.
8.2 Observations and Findinog 10 CFR 19.13(b) requires that the licensee advise each radiation worker annually of the workers dose. The licensee used an approved personnel monitoring service to provide personnul involved in nuclear medicine activities with whole body and extremity monitoring badges. The inspectors review of licensee personnel monitoring records revealed that technologists who had worked in nuclear medicine historically received less than 350 millirems total per calendar year from his/her dual duties in dingnostic x ray and the nuclear medicine department. The maximum extremity dose rwalved by a nuclear medicine technologist for a year was 110 millirem. During the review of the licensee's exposure records, the inspector determined that the licensee had failed to annually advice each person who had performed the duties of a nuclear medicine technologist of the workers dose as shown in records maintained by the licensee pursuant to 20.2106 of Part 20. The failure of the licensee to advise each worker annually of the workers dose was identified as an apparent violation of 10 CFR 19.13(b) (030 32210/97-18).
10 CFR 35.14(b)(1) requires the licensee to notify the NRC by letter when an authnrlzed user permanently discontinues his/her performance of duties under the license. During discussions with the licerisee's RSO after the onsite portion of the inspection, the inspector was informed that an authorized user listed on WRMC's license had discontinued the performance of his duties as an authorized user with WRMC in 1995. During discussions with WRMC personnel and the licensee's RSO, the inspector determined that the licensee had not notified the NRC by letter within thirty days after an authorized user had permanently discontinued his duties with WRMC, During discussions with the radiology department director, the inspector determined that she was not aware of this notification requirement. The failure of the licensee to notify the NRC by letter when an authorized user permanently discontinued his performance of duties under the license was identified as an apparent violation of 10 CFR 35.14(b)(1) (030 32210/9719).
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-15 The inspector noted that Attachment 9.1 of the licensee's license application dated September 25,1992, described the nuclear medicine hot lab and imaging room as being located in the basement of the WRMC. However, at the time of the inspection, the licensee was using facilities on the main floor of the hospital for a hot lab and imaging room. During discussions with licensee management, the inspector determined that the licensee had relocated its nuclear medicine activities to the main floor of the hospital on March 28,1994.10 CFR 35.13(e) requires a licensee to apply for and receive a license amendment before relocating an area of use of licensed materials. The licensee's radiology director indicated that she was not aware of this requirement. Although the licensee moved its daily nuclear medicine activities.) the new main floor location, the basement room location was still being used as a remote radioactive waste storage area. The failure of the licensee to have applied for and received a license amendment prior to relocating an area of use of licensed material was identified as an apparent violation of 10 CFR 35.13(e) (030 32210/97 20).
10 CFR 30.34 states, in part, that a license issued or granted pursuant to the regulations in this part and Parts 31 through 36, and 39, nor any right under a license shall be transferred, assigned or in any manner disposed of either voluntarily or involuntari!y, 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. Based on interviews with licensee management and review of information submitted by the licensee during the inspection, it appeared that the licensee underwent a change in control as a result of the creation of a new entity, Healthcare Partnership, in 1992. The inspection also revealed that the licensee underwent another change in control recently and was now under the control of Healthcare Authority, a joint city-county heahhcare authority created by Blaine County and the City of Sun Valley, Idaho. During discussions with licensee management, the inspector determined that WRMC management was not aware that a change in control of licensed material had occurred in 1992, or that the recent change had impacted control of licensed activities. The failure of the licensee to have obtained the NRC's written consent prior to implementing a change in control of licensed activities was identified as an apparent violation 10 CFR 30.34 (030-32210/97 21).
8.3 Conclusions Four apparent violations of NRC requirements were identified, including failures to:
(1) advise each worker annually of the worker's dose as f hown in records maintained by the licensee, (2) notify the NRC by letter when an authorized user permanently discontinued his performance of duties under the license, (3) apply for and receive a license amendment before relocating an area of use of licensed material, and (4) obtain the NRC's written consent prior to implementing a change in control of licensed activities. Once again, tne licensee's lack of familiarity with NRC requirements, coupled with inadequate program oversight and control by management and the RSO, contributed to the apparent violation.
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Completeness and Accuracy of information (87100)
l 9.1 Inspection Scope
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This portion of the inspection included interviews with licensee personnel and a review of licensee records to determine if the licensee had maintained complete and accurate information relating to the use of licensed materials.
9.2 Observations and Findinas In a letter to the NRC dated October 15,1997, the licensee's Chief Operating Officer (COO) disclosed that the radiology department director was informed by a technologist that he had not always performed daily contamination surveys, even though entries in the daily log indicated the surveys had been performed. Further, the COO indicated that the technologist understood the requirement to properly perform i
contamination surveys, and in fact, the surveys were done correctly at times.
However, on occasions when the technologist did not perform the surveys, he
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admitted to making entries in the log that closely proximated the survey data obtained from actual surveys performed previously. A consulting physicist, hired by the
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licensee to perform a radiation safety program review, identified in a report dated October 28,1997, that apparently some entries were made in the survey logs, when in fact, some of the indicated surveys had not physically been performed.
10 CFR 30.9 requires, in part, that information maintained by an applicant for a license or by a licensee or information required by statute or by the Commission's regulations, orders, or license conditions to be maintalr'ed by the applicant or the licensee shall be complete and accurate in all material respects. Based on the technologist's admission, as noted above, the failure of the licensee to maintain complete and accurate information was identified as an apparent violation of 10 CFR 30.9 (030 32210/97-22).
The consulting physicist's program review and an independent review by the NRC inspector established that as many as 67 daily surveys had not been perfonned and/or recorded; however, neither the consulting physicist nor the NRC inspector were able to identify which entries in the survey logs had been falsified.
9.3 Conclusion An apparent violation of NRC requirements was identified involving the licensee's failure to have maintained complete and accurate information regarding the use of licensed materials. Specifically, based on information developed by the licensee and during the inspection, it appeared that an unknown number of survey records maintained by the licensee were not complete and accurate.
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10 Causes & Contributing Factors and Licensee Corrective Actions (87100)
10.1 Inspection Scong This portion of the inspection included interviews with licensee personnel, observations of licensee activities, and the review of licensee records to determine the probable causes and contributing factors associated with a breakdown in the licensee's radiation safety program. This portion of the inspection also included review of corrective actions the licensee had implemented or planned to implement.
10.2 Qhservations and Findinos Based on the inspector's review of the consultant's audit report and an independent review of the licensee's radiation safety program, the inspection identified the lack of management and RSO oversight and control of licensed activities to be the root cause for the programmatic breakdown of the licensee's radiation safety program. During discussions with licensee management and the RSO, the inspector noted that neither management nor the RSO had taken an active part in providing program oversight.
Both the RSO and licensee management acknowledged that they had largely depended on nuclear medicine personnel to follow NRC requirements with little oversight. A contributing cause of the program breakdown included the practice of assigning radiology personnel, who had either limited or no formal nuclear medicine training, to nuclear medicine duties and responsibilities, in addition, these personnel had been trained by their predecessors who also had received little or no formal nuclear medicine training.
The inspector determined that on October 14,1997, the licensee had permanently removed from nuclear medicine duties the technologist who admitted to falsifying survey records. This was four days after the admission. On October 13,1997, the licensee's radiology director contacted a consulting nuclear medicine technologist and arranged for him to review the licensee's contamination survey procedure. Based on the consulting technologist's recommendation, a consulting physicist was hired to perform a radiation safety program review. The program review was performed on October 28 and 30,1997, in a letter dated October 15,1997, the licensee committed to requiring the RSO to review contamination survey records once each week and sign-off on the records for a period of 12 weeks to ensure continued compliance. The inspector verified that the RSO had reviewed the survey records and had signed-off as indicated.
The licensee's consulting physicist performed the radiation safety program review on October 28 and 30,1997, with a summary report dated October 28,1997 provided to i
the licensee. The inspector determined that the licensee had requested that the consulting physicist initiate corrective measures during his visit. The inspector further noted that the licensee's corrective actions included a contract with the consulting physicist to perform quarterly radiation safety program reviews including the performance of instrument calibrations, radiation surveys, and refresher training.
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-18-i 10.3 Conclusions The inspection determined that the licensee had appropriately identified root and contributing causes to the radiation safety program breakdown. The licensee's actions included an independent radiation safety program review performed by a consulting physicist that appeared effecthe in identifying numerous program weaknesses and root causes, as well as implementing numerous corrective measures during the onsite visit on October 28 and 30,1997,
Exit 13eeting Summary The inspector presented the preliminary inspection findings to licensee management on November 5,1997. A telephonic exit briefing was conducted with you on December 30,1997. The licensee confirmed during the exit briefing that no proprietary information was reviewed by the inspecto.
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ATTACHMENT PARTIAL LIST OF PERSONS CONTACTED LIG9.Qtti R. Davis, M.D., RSO G. Goglia, COO J. Meadows, Director of Patient Care Services J. Truxal, Radiology Manager M. Askew, Human Resource Director A. Raybom, Nuclear Medicine Technologist Othem J. Fletcher. Consulting Physicist J. Risner, Nuclear Medicine Technologist J. Johnson, Nuclear Medicine Technologist E. Alberdi, X Ray Technologist J. Gramkow, X-Ray Technologist INSPECTION PROCEDURES USED 87100 Licensed Materials Program 83822 Radiation Protection LIST OF ACRONYMS USED l
ALARA As Low As Reasonably Achievable COO Chief Operating Officer NRC Nuclear Regulatory Commission RCS Radiation Safety Committee RSO radiation safety officer-WRMC -
Wood River Medical Center ITEMS OPENED. CLOSED. AND DISCUSSED Opened 030-32210/g701-01 APV Apparent violation of 10 CFR 35.25(a) involving the RSO's failure to properly supervise an individual under his supervision during the performance of nuclear medicine activities.
030 32210/g701-02. APV Apparent violation of 10 CFR 35.21(a) involving the failure of the licensee through the RSO to ensure that radiation safety activities were being performed in accordance with Commission regulations, license conditions, and licensee's radiation safety procedures.
-.030-32210/g701-03 APV Apparent violation of 10 CFR 35.22(a)(2) involving the failure of the licensee's radiation safety committee to meet quarterly.-
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2-l 030 32210/9701 04 APV Ispparent violation of 10 CFR 35.22(b)(4) involving the licensee's
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failure to conduct quarterly At. ARA reviews.
030 32210/9701-05 APV Apparent violation of 10 CFR 20.1101(c) involving the failure of the licensee's RSC, with the assistance of the RSO, to review annually the licensee's f adiation safet; wogram.
t 030 32210/970106 APV Apparent violation of License Condition 15 involving the failure of the licensee to provide radiation safety refresher training for nuclear medicine personnel.
030 32210/970107 APV Apparent violation of 10 CFR 35.50(b)(3; involving the failure of
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the licensee to perform quarterly dose calibrator linearity test for
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eight quarters.
030 32210/9701-08 APV Apparent violation of 10 CFR 35.50(b)(2) and 35.50(e)(2)
involving the licensee's failure to use different sealed sources and include the individual's name performing the accuracy test on date indicated.
030-32210/9701-09 APV Apparent violation of 10 CFR 35.50(e)(4) involving the licensee's failure to identify the source configuration used to test the dose calibrator geometry dependence.
030 32210/970110 APV Apparent violation of 10 CFR 35.70(a) involving the licensee's failure to have performed daily ambient radiation area surveys in areas where licensed material had been prepared or used.
030 32210/9701-11 APV Apparent violation of 10 CFR 35.70(b) involving the licensee's failure to perform weekly ambient radiation area surveys in all areas where radiopharmaceuticals or radiopharmaceutical waste had been stored.
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030 32210/970112 APV Apparent violation of 10 CFR 35.59(a)(2) involving the failure of the licensee to perform leak tests on two sealed sources on six month intervals.
030-32210/9701-13 : APV Apparent violation of 10 CFR 35.59(d) involving the licensee's failure to include the signature of the RSO on leak test records.
030 32210/9701-14 APV Apparent violation of 10 CFR 35.59(g) involving the licensee's failure to conduct physicalinventories of sealed sources on a quarterly interval.
030-32210/9701 15 APV Apparent violation of 10 CFR 20.1906(a)(1) involving the licensee's failure to perform package receipt surveys for licensed material.
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3-030 32210/970116 APV Apparent violation of 10 CFR 35.53(c)(5) involving the licensee's failure to record the identity of the individual administering patient doses on the patient dose administration record.
030 32210/970117 APV Apparent violation of 10 CFR 35.92(b) involving the licensee's failure to include required information on the radioactive waste disposal records.
030 32210/970118 APV Apparent violation of 10 CFR 19.13(b) involving the licensee's failure to have advised each worker annually of the worker's dose as shown in records maintained by the licensee.
030 32210/970119 APV Apparent violation of 10 CFR 35.14(b)(1) involving the licensee's failure to notify the NRC by letter when an authortzed user permanently discontinued his performance of duties under the license.
030 32210/970120 APV Apparent violation of 10 CFR 35.13(e) involving the licensee's failure to have applied for and received a license amendment before relocating its area of use.
030-32210/9701 21 APV Apparent violation of 10 CFR 30.34 involving the licensee's failure to have obtained the NRC's prior written consent involving a change in control of licensed activities.
030 32210/970122 APV Apparent violation of 10 CFR 30.9 involving the licensee's failure to maintain complete and accurate information.
Closed None Qiasussed None