ML18215A099
| ML18215A099 | |
| Person / Time | |
|---|---|
| Site: | 03037750 |
| Issue date: | 07/24/2018 |
| From: | Gattone R G NRC/RGN-III |
| To: | Steven Rose James E. Cary Cancer Ctr |
| References | |
| IR 2018001 | |
| Download: ML18215A099 (2) | |
See also: IR 05000201/1980001
Text
NRC FORM 591M PART 1 U.S. NUCLEAR REGULA TORY COMMISSION
(07-2012)
10CFR 2.201 SAFETY INSPECTION
REPORT AND COMPLIANCE
INSPECTION
1. LICENSEE/LOCATION
INSPECTED:
2. NRG/REGIONAL
OFFICE :5" tk "'e i f. C << rt_ C r;..J.Jce
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"' lie {( ,J"J S' v, f l IO L.isl~1.X.lli"oi5, o51'l. Select a location (Use keyboard arrows to select) ... REPORT NUMBER(S}
- 2 D I g (} 0 I 3. DOCKET NUMBER(S)
4. LICENSE NUMBER(S)
5. DATE(S) OF INSPECTION
a 3 O ._ J 7 7 ~() 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. Based on the inspection
findings, no violations
were identified.
D 2. Previous violation(s)
closed. D 3. D 4. 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 10 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
DATE LICENSEE'S
REPRESENTATIVE
NRCINSPECTOR
BRANCH CHIEF NRC FORM 591M PART 1 (07-2012) )h,V _ fbr A-TM V
NRC FORM 591 M PART 3 (07-2012)
10 CFR2.201 U.S. NUCLEAR REGULA TORY COMMISSION
Docket File Information
SAFETY INSPECTION
REPORT AND COMPLIANCE
INSPECTION
1. LICENSEE/LOCATION
INSPECTED:
James E. Cary Cancer Center 5985 Hospital Drive Hannibal, Missouri REPORT NUMBER(S)
201800 I 3. DOCKET NUMBER(S)
030-37750
6. INSPECTION
PROCEDURES
USED 87132 2. NRG/REGIONAL
OFFICE 4. LICENSE NUMBER(S)
24-32681-01
Region III U.S. Nuclear Regulatory
Commission
2443 Warrenville
Road, Suite 210 Lisle, IL 60532-4352
5. DATE(S) OF INSPECTION
7/24/18 7. INSPECTION
FOCUS AREAS 02.01 through 02.07 SUPPLEMENTAL
INSPECTION
INFORMATION
1. PROGRAM CODE(S) 02230 2. PRIORITY 2 [{] Main Office Inspection
D Field Office Inspection
D Temporary
Job Site Inspection
3. LICENSEE CONTACT Stephen Rose, RSO Next Inspection
Date: 4. TELEPHONE
NUMBER (573) 406-5801 07/24/2020
PROGRAM SCOPE This was an unannounced, routine inspection.
The licensee conducted
High Dose Rate (HDR) remote afterloader
using an authorized
HDR remote afterloading
device. The treatments
included breast treatments
involving
Mammosite
or Contura applicators, In addition, the licensee conducted
vaginal treatments.
As of the inspection, the licensee conducted
5 HDR treatments
since January 1, 2018. An authorized
user was as required.
The licensee's
radiation
safety officer (RSO)
was the licensee's
authorized
medical physicist.
The RSO reported to the Director of Radiation
Oncology (DRD), and the DRD reported to the Vice President
of Operations.
There were 3 radiation
therapists, one of which was the DRD. There were no HDR treatments
during the inspection.
Performance
Observations
The inspector: (I) observed that the HDR device was properly secured during storage; (2) discussed
Elekta's Notice Reference
806-01-BTP-OOI
regarding
potential
Oncentra software issues, and the inspector
verified that the licensee's
Oncentra software was Version 4.5.3 which does not have the software issues; (3) observed the licensee's
HDR emergency
procedure
posted at the HDR treatment
area; ( 4) observed the RSO demonstrate
how he conducted
HDR spot checks and there was no concern; (5) noted that the RSO stated that none of the HDR treatments
deviated from the written directive
or treatment
plan; (6) observed that the licensee's
survey instrument
was calibrated
as required;
(7) used an NRC-owned
survey meter to conduct a side-by-side
ambient exposure survey at the surface of the HDR unit containing
an iridium-192
source containing
7. 7 curies, and the inspector's
survey result was O .2 milliRoentgen
per hour and the RSO measured the same result with the licensee's
survey instrument;
(8) observed that the HDR facility was as authorized;
(9) noted that the facility was posted as required;
(10) noted that the licensee placed emergency
response equipment (i.e., wire cutters, large pig, and a remote handling tool) near the patient during treatment
in the event that a problem occurs that results in high radiation
dose rates; ( 11) reviewed selected HDR treatment
records for vaginal and breast treatments, including
overlays of anatomy and dose information, written directives, treatment
plans, and pre-and post-treatment
HDR computer printouts
that were used to verify that the HDR unit was set to conduct the proper HDR treatment
prior to treatment
and ensuring that the HDR unit conducted
the proper HDR treatment
post treatment;
and (12) reviewed dosimeter
badge results for 2016 through 6/30/18, and the highest annual extremity
and whole body doses were 38 millirem (mrem) and 4 mrem, respectively.
No violations
ofNRC regulatory
requirements
were identified
as a result of this inspection.
6\J flit. A-t;J'J ff/i../, t NRC FORM 591M PART 3 (07-2012)