ML18213A137
| ML18213A137 | |
| Person / Time | |
|---|---|
| Site: | 03002048 |
| Issue date: | 07/10/2018 |
| From: | Harvey E F NRC/RGN-III |
| To: | Conlin C J McLaren - Flint |
| References | |
| IR 2018001 | |
| Download: ML18213A137 (2) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULATORY COMMISSION (07-20121 10CFR 2.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED
- 2. NRCIREGIONAL OFFICE McLaren -Flint Region Ill 40 I S. Ballenger Hwy. Flint, Ml 48532 U. S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 201800 I 3. DOCKET NUMBER(S) 030-02048
- 4. LICENSE NUMBER(S) 21-04171-04
- 5. DATE(SI OF INSPECTION July I 0. 2018 LICENSEE:
The inspection was an examination of the activities conducted under your license as they relate to radiation safety and to compliance with the Nudear Regulatory Commission (NRG) 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 1. I 2. I l 3. 1./ 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 NRG 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 NRG 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) Contrary to Title 10 of the Code of Federal Regulations (IO (TR) Section 35.643(d)(6).
on multiple occa:-ions.
including July 9, 2018. the licensee failed to assure proper timer accuracy of the licensee's high dose-rate remote afterloadcr (HOR) unit prior to patient treatment.
which is required to be performed before the first use of the HDR on a given day in accordance with 10 (TR 35.643(a)( I). This is a Severity Level IV violation.
As l'orn.:ctive action. on July I 0. 2018. the licensee updated its I !DR start-up checklist to include a timer accuracy check. All pct1inent staff will be made aware of the change to the start-up procedure prior to thl'ir nl'xt use of the II DR device. 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 10 CFR 2.201 (corrective steps already taken. corrective steps which will be taken. date when full compliance w,11 be achieved).
t understand that no further written response to NRC will be required, unless specifically requested.
TITLE PRINTED NAME SIGNATURE DATE NRC INSPECTOR hh\ard F. llarwy .. _,,. 7n0201R ,*** I BRANCH CHIEF Aaron T. l\kCraw /, ,, --------------------------------.:4 6 '~*~ / :,1 /, .* 07/30/2018 NRC FORM 591M PART 1 !07*2012!
NRC FORM 591M PART 3 (07-2012) 10CFR2.201 U.S. NUCLEAR REGULATORY COMMISSION Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION
- 1. LICENSEE/LOCATION INSPECTED:
McLaren -Flint 40 I S. Ballenger Hwy. Flint, MI 48532 REPORT NUMBER(S) 2018001 3. DOCKET NUMBER(S) 030-02048
- 6. INSPECTION PROCEDURES USED 87131, 87132 2. NRG/REGIONAL OFFICE 4. LICENSE NUMBER(S) 21-04171-04 Region III U. S. Nuclear Regulatory Commission 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352
- 5. DATE(S) OF INSPECTION July 10, 2018 7. INSPECTION FOCUS AREAS All SUPPLEMENTAL INSPECTION INFORMATION
- 2. PRIORITY 3. LICENSEE CONTACT 4. TELEPHONE NUMBER 1. PROGRAM CODE(S) 02230 2 Christopher Conlin, MD -RSO (810) 342-3930 [{] Main Office Inspection Next Inspection Date: July I 0, 2020 [{] Field Office Inspection 4100 Beecher Road, Flint, MI D Temporary Job Site Inspection PROGRAM SCOPE This was an unannounced routine inspection of a hospital authorized to use byproduct material for diagnostic and therapeutic medical procedures permitted by IO CFR 35.100, 200, 300, 400, 600, and I 000. The licensee operated three adjacent facilities in Flint, Michigan.
At the time of the inspection, the nuclear medicine department within the main hospital performed approximately seven diagnostic studies per day (mostly cardiac) with one full-time technologist.
This department also performed occasional administrations of I-131 for hyperthyroidism therapy and whole body scans. The cancer center, located at 4100 Beecher Road, performed approximately two HOR treatments per day. The majority of these procedures were skin treatments with occasional gynecological administrations.
In addition, the cancer center also performed three to four therapeutic administrations of unsealed radiopharmaceuticals per month, including I-131 and Ra-223. Although authorized, the licensee has not performed any manual brachytherapy implants or GliaSite therapies since the last inspection.
The inspector toured the main hospital and cancer center in Flint to evaluate the licensee's measures for materials security, hazard communication, and exposure control. The inspector conducted independent and confirmatory surveys of these facilities and found no residual contamination or exposures to members of the public in excess of regulatory limits. The inspector observed the administration of two HOR skin treatments, a cardiac stress test, and a multi-gated acquisition (MUGA) scan with no issues noted. Licensee staff also demonstrated and discussed procedures for package receipt, area surveys, spill response, waste handling, and release of patients following I-131 administrations.
Through these observations and discussions, the inspector found the licensee's staff to be knowledgeable ofradiation protection principles.
The inspector reviewed a selection of relevant records, including written directives, treatment plans, equipment calibrations, consultant audits, source inventories, and dosimetry reports. One violation ofNRC requirements, described in Part I of this record, was identified during this inspection.
NRC FORM 591 M PART 3 (07-2012)