ML18194A934
| ML18194A934 | |
| Person / Time | |
|---|---|
| Site: | 03001597 |
| Issue date: | 06/25/2018 |
| From: | O'Dowd D P NRC/RGN-III/DNMS/MIB |
| To: | Parrott M J Columbus Regional Hosp, Columbus, IN |
| References | |
| IR 2018001 | |
| Download: ML18194A934 (3) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-2012) 10CFR2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Columbus Regional Hospital 2400 E 17th St. Columbus, IN 47201 REPORT NUMBER(S) 2018001 2. NRG/REGIONAL OFFICE Region III U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352
- 3. DOCKET NUMBER(S) 030-01597
- 4. LICENSE NUMBER(S) 13-01631-05
- 5. DATE(S) OF INSPECTION 4/04/18, with cont'd in-office review through 6/25/18 LICENSEE:
The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nuclear Regulatory Commission (NRC) rules and regulations and the conditions of your license. The inspection consisted of selective examinations of procedures and representative records, interviews with personnel, and observations by the inspector.
The inspection findings are as follows: [{] 1. D 2. D 3. D 4. Based on the inspection findings, no violations were identified.
Previous violation(s) closed. The violations(s), specifically described to you by the inspector as non-cited violations, are not being cited because they were self-identified, non-repetitive, and corrective action was or is being taken, and the remaining criteria in the NRC Enforcement Policy, to exercise discretion, were satisfied.
Non-cited violation(s) were discussed involving the following requirement(s):
During this inspection, certain of your activities, as described below and/or attached, were in violation of NRC requirements and are being cited in accordance with NRC Enforcement Policy. This form is a NOTICE OF VIOLATION, which may be subject to posting in accordance with 10 CFR 19.11. (Violations and Corrective Actions) Statement of Corrective Actions I hereby state that, within 30 days, the actions described by me to the Inspector will be taken to correct the violations identified.
This statement of corrective actions is made in accordance with the requirements of 1 O CFR 2.201 (corrective steps already taken, corrective steps which will be taken, date when full compliance will be achieved).
I understand that no further written response to NRC will be required, unless specifically requested.
TITLE PRINTED NAME SIGNATURE DA TE LICENSEE'S REPRESENTATIVE NRC INSPECTOR Dennis P. O'Dowd BRANCH CHIEF Aaron T. McCraw NRC FORM 591M PART 1 (07-2012)
-=1-/ 1 ?J/1 B I NRC FORM 591 M PART 3 (07-2012) 10 CFR2.201 U.S. NUCLEAR REGULATORY COMMISSION Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Columbus Regional Hospital 2400 E 17th St. Columbus, IN 47201 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER($)
030-01597
- 6. INSPECTION PROCEDURES USED 87131, 87132 2. NRG/REGIONAL OFFICE 4. LICENSE NUMBER(S) 13-01631-05 Region Ill U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352
- 5. DATE(S) OF INSPECTION 4/04/18, with cont'd in-office review through 6/25/18 7. INSPECTION FOCUS AREAS All SUPPLEMENTAL INSPECTION INFORMATION
- 1. PROGRAM CODE(S) 02240 2. PRIORITY 2 [lJ Main Office Inspection D Field Office Inspection D Temporary Job Site Inspection
- 3. LICENSEE CONTACT 4. TELEPHONE NUMBER Michael J. Parrott, Ph.D., RSO (260) 982-6021 Next Inspection Date: April 2020 PROGRAM SCOPE This was an unannounced, routine inspection of a medical institution authorized to use licensed material permitted by 10 CFR 35.100, 35.200, 35.300, 35.400, and 35.600 (lr-192 in HDR). The licensee's nuclear medicine department routinely conducted a daily average of 8-9 patient studies with a staff of 3 nuclear medicine technologists (NMTs ). The majority of diagnostic studies were cardiac, bones, gastric, and gall bladder tests. I-123 was used for uptake studies. No administrations ofl-131 requiring a written directive have been given since June 2016. Ra-223 Xofigo was administered to one patient (5 treatments) in late 2017-early 2018. The licensee received licensed material as unit doses and bulk pertechnetate from an Indianapolis nuclear pharmacy as needed. The licensee also had a separate PET facility and averaged 4-5 patient studies each weekday with two NMTs. The licensee also utilized a Sr 82/Rb-82 generator used for myocardial perfusion PET imaging. The licensee had not performed sealed source implant procedures in several years; these sources were removed and disposed ofin 2016. The licensee was newly authorized for 35.600 HDR Ir 192 in June 2016. This program was reviewed during a special inspection in October 2017. Since that time, 65 HDR treatments have been administered.
PERFORMANCE OBSERVATIONS The inspector toured the nuclear medicine, PET imaging, and HDR treatment areas to evaluate the licensee's measures for materials security, hazard communication, and exposure control. The inspector observed several diagnostic studies, including PET scans and use of the Sr-82/Rb-82 generator in a myocardial perfusion study. No therapeutic procedures involving sealed or unsealed sources were conducted by the licensee at the time of the inspection.
The inspector observed, and the licensee's staff demonstrated and discussed, various procedures, including package receipt, instrument quality control, daily/weekly area surveys, waste handling, and spill response in nuclear medicine; planning and administration for therapeutic procedures, and HDR spot checks and full calibrations, treatment planning, and emergency response in radiation oncology. (Continued on Part 2) NRC FORM 591M PART 3 (07-2012)
NRC FORM 591M PART 2 U.S. NUCLEAR REGULATORY COMMISSION
- ';;ti~2 d.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
Columbus Regional Hospital 2400 E 17th St. Columbus, IN 47201 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER(S) 030-01597 (Continued)
- 2. NRC/REGIONAL OFFICE Region III U.S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352
- 4. LICENSE NUMBER(S)
- 5. DATE(S) OF INSPECTION 4/04/18, with cont'd in-office review through 6/25/18 13-01631-05 The inspector performed independent and confirmatory radiation measurements which indicated results consistent with licensee survey records and postings.
The inspector also reviewed a selection of relevant records, including routine nuclear medicine records, quarterly department audits, RSC meeting minutes, consultant's reports, training records (hazmat, HDR emergency response, and annual training), HDR spot checks and full calibrations, written directives and treatment verifications for 1-131, Xofigo, and HDR treatments, and dosimetry records, with no issues were identified.
The review of dosimetry records indicated no exposures of regulatory concern. Use of Strontium-82 (Sr-82)/Rubidium-82 (Rb-82) Generators Both the onsite inspection and the in-office review included a review and discussion of the licensee's procedures for the use of Sr-82/Rb-82 generators.
Based on the results of the inspection, the NRC noted that two Severity Level IV violations ofNRC requirements regarding the use of Sr-82/Rb-82 generators that had been identified and discussed previously during an inspection conducted on April 26, 2016, (with continued in-office review through May 24, 2016, ref. EA-16-121, Inspection Report No. 03001597/2016(DNMS)), remain violations of IO CFR 35.60 and 35.63. During the inspection, the inspector noted that, since the last inspection, the licensee continued to implement its Sr-82/Rb-82 generator program in a manner that satisfied all of the criteria in NRC Enforcement Guidance Memorandum (EGM) 13-003, "Interim Guidance for Dispositioning Violations Involving IO CFR 35.60 and IO CFR 35.63 for the Calibration oflnstrumentation to Measure the Activity ofRubidium-82 and the Determination ofRubidium-82 Patient Dosages." As such, the NRC is continuing to exercise enforcement discretion to not issue any enforcement action for these violations.
No additional violations ofNRC requirements on which the NRC is taking enforcement action were identified during this inspection.
NRC FORM 591M PART 2 (07-2012)