IR 015000012/2019001
| ML19058A573 | |
| Person / Time | |
|---|---|
| Site: | 15000012, 015000012 |
| Issue date: | 02/14/2019 |
| From: | Folch L NRC/RGN-III |
| To: | Doran J Medical Outsourcing Solutions |
| References | |
| IR 2019001 | |
| Download: ML19058A573 (3) | |
Text
NRC FORM 591M PART 1 U.S. NUCLEAR R!OUI.ATORV COMMf8BtON (07,:11112)
tOCFflt.201 SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION t. LICENSl!l:JI.OCATIOH INSPECTED: 2. NRC/ReGIONAL OFFICE Medical Outsourcing Solutions Region rn 173S DeKalb Ave U.S. Nuclear Regulatory Commission Sycamore, IL 60178 2443 Warrenville Road, Suite 2 I0 Lisle, lL 60532-4352 REPORT NUMBER(S) 201900 I 3. DOCKET M8!R(S) 4, LICENSE Nt,8Efl(8) II. OATE(S) OF INSPl!CTION IS0-00012 IL-02186.tOI February I4, 20 I9 LICENSEE:
Tha lntJ]8dlon WIii 8fl l'lxamlnallon or lhe 1ctlvllies condutled undar your lcen1n as lhey rel&le to radlallon Hloly and lo complance with Ille Nudear Regulatory Comrnlnlon (NRC) rule1 and regulltllans and lhe condlllo1111 oly111II' license. The lnap11cllon conll!lted oheleclllllt examlnllllons of procadum and repreuntalfve records, lntervlllWI with persmmal, and o1>1ervallan11 by lbt lnspeclor. Ttte lnspecllon findings are II loffows:
Q 1. Based on the Inspection findings, no vlolBtlons ware ldenllfled.
n 2. Prevlous vtolatlon(s) Closed.
I_ I 3. The vtoletlons(1), 1peelblly described 10 you by !he lnspeclor as non-clled vtolaUona, are not being died beceuae !hey were salt-Identified, non..,.etlllva, and comtdlve actlon wa, or Is being lalten, and Iha remaining mt1erl1 In the NRC Enforcement Poftcy, lo exerc:1111 dlsctellon, were sat11fted.
Nol)oclled vlolallon(a) were discussed Involving the following ,equlrement(e):
During 1h11 lntpecllon, certain of your acllVlllea, as descrlbad beloW end/or atlached, Wlltl In vlolallon of r,a:cc requirements and are being cited In acconlanca Wilh NRC Enforcement Polley. Thll lolm Is I NOTICE OF VIOLATION, which may be BUbjeCI lo poalfn9 In accartfame v.tlh 10 CFR 18.11.
(VI01atlon1 and Comtctlve Acllon1)
Contrary to Title 10 ofthe Code of Federal Regulations (CFR) 20.1802, on February 14, 2019, the licensee failed to control and maintain constant surveillance of licensed material that was In a controlled or unrestricted area and that was not in storage. Specifically, the licensee's two technologists left the vehicle unattended and not under direct surveillance with prepared doses totaling approximately 113 mCi of technetlum-99m and a flood source containing approximately 6.54 mCi ofCo-57 while going back to the clinic to keep unloading the vehicle. The cause of the violation was a licensee oversight. The licensee technologists were in a hurry to unload the vehicle and forgot to lock the vehicle. The technologists normally use a cart to bring all the doses at once, so that the material Is never unatlended, but that day they did nol have the cart. As corrective actions, Radiation Safely Officer has talked to the technologists and retrained them, and the RSO will also provide a dedicated cart for that vehicle.
Statement of Correctlve Actions I hereby llale Iha!, within 30 days, the actions deacnbed by me to the lnapeclor wtll be laken lo cosmit Iha vlclatlons ldenlllled, This 11111e1111n1 or correcllve 1c:tlons la made In accordance v.tlh lhe requirements of 10 CFR 2.2D1 (corrective steps al,endy taken, cormctlvo atep1 "Which will be IDkell.
dale when Ml compffance wffl be achieved). I underatand Iha! no rurther written Jespllf!se lo NRC wlll be required, unless spadllCllll}' requnled.
NRC INSPECTOR Luis Nieves Folch
~ANCH CHIEF Aaron T. McCraw NRC l'ORM 591M PART 1 (07*20'2)
NRC FORM 591M PART 3 U.S. NUCLEAR REGULATORY COMMISSION (07-2012)
10 CFR 2.201 Docket File Information SAFETY INSPECTION REPORT AND COMPLIANCE INSPECTION 1. LICENSEE/LOCATION INSPECTED: 2. NRG/REGIONAL OFFICE Medical Outsourcing Solutions Region III 1735 DeKalb Ave U. S. Nuclear Regulatory Commission Sycamore, IL 60178 2443 Warrenville Road, Suite 210 Lisle, IL 60532-4352 REPORT NUMBER(S) 2019001 3. DOCKET NUMBER(S) 4. LICENSE NUMBER(S) 5. DATE(S) OF INSPECTION JJ 150-00012 IL-021861-01 February 14, 2019 6. INSPECTION PROCEDURES USED 7. INSPECTION FOCUS AREAS 87130 03.01-03.08 SUPPLEMENTAL INSPECTION INFORMATION 1. PROGRAM CODE(S) 2. PRIORITY 3. LICENSEE CONTACT 4. TELEPHONE NUMBER 02220 3 Jim Doran-RSO (815) 757-5056 D Main Office Inspection Next Inspection Date: TBD D Field Office Inspection
[l] Temporary Job Site Inspection 10176 W 400 North, Michigan City, IN PROGRAM SCOPE This was an unannounced reciprocity inspection of a medical service provider authorized to use and store radioactive material for diagnostic imaging at various facilities in Illinois and at temporary job sites in Illinois jurisdiction. The company conducted these activities at temporary job sites in NRC jurisdiction under a reciprocity request. During this inspection, two nuclear medicine technologists used unit doses ofTc-99m to perform cardiac stress tests on the premises ofLakeshore Cardiovascular Institute LLC in Michigan City, Indiana. The technologists transported these doses, along with other equipment, from one of the company's facilities in Illinois.
PERFORMANCE OBSERVATIONS: The inspector observed the conduct of two cardiac rest tests while at the job site in Michigan City, and noted the satisfactory use of ALARA practices and personnel dosimetry. The technologists adequately verified the identity of all patients and accounted for radioactive decay mathematically to ensure doses were within range at time of administration. The inspector conducted independent surveys of the client's facility following the morning tests, and found no evidence of residual contamination. The inspector interviewed the technologists to discuss area surveys, waste handling, spill response, and transportation of radioactive material. The inspector also reviewed a selection of available records, including client agreements, shipping papers, dosimetry reports, and documentation of package receipt, dose administration, and area surveys.
The inspector identified a Severity Level IV violation of 10 CFR 20.1802 for the failure to control and maintain constant surveillance of 8 unit doses of Tc-99m totaling approximately 113 mCi and a flood source containing approximately 6.54 mCi of Co-57. The inspector observed the technologists arrive and unload equipment. One went inside and the second one remained unloading the vehicle, when the second technologist went inside the clinic with half the licensed material. Both technologists were gone for several minutes, during which time the licensed material was left unattended inside the open vehicle outside the facility. The root cause appeared to be an oversight. As corrective action, the Radiation Safety Officer has talked to the technologists and retrained them, and the RSO will also provide a dedicated cart for that vehicle. On February 26, 2019 the inspector and the company's RSO discussed the requirement and best practices for ensuring security of licensed material.
No other violations were identified as a result of this inspection.
NRC FORM 591M PART 3 (07-2012)
From: Nieves Folch, Luis Sent: Wednesday, February 27, 2019 1:10 PM To: Warren, Geoff Subject: FW: RE: NRC 591 Report Severity Level IV Violation Attachments: nrc nov feb 2019_20190227125840.pdf From: Jim Doran [1]
Sent: Wednesday, February 27, 2019 12:56 PM To: Nieves Folch, Luis <Luis.NievesFolch@nrc.gov>
Subject: [External_Sender] RE: NRC 591 Report Severity Level IV Violation Luis, attached is the signed 591 report - the corrective actions have been implemented today.
Jim Doran From: Nieves Folch, Luis <Luis.NievesFolch@nrc.gov>
Sent: Wednesday, February 27, 2019 9:33 AM To: Jim Doran <jdoran@micmos.com>
Subject: NRC 591 Report Severity Level IV Violation This email contains an attachment. If you do not recognize the Sending email address of this email or if anything looks suspicious, DO NOT OPEN the attachment and forward the email to your support team for analysis.
Dear Mr. Daron,
Attach is the 591 report for the inspection conducted on February 14, 2019. The report includes a Severity Level IV violation. At this moment is required of you to sign the Report where it says Licensee's Representative and email it back to me. After that there is no further actions on your part.
In accordance with Title 10 of the Code of Federal Regulations 2.390 of the NRC's "Rules of Practice," a copy of this message will be available electronically for public inspection in the NRC's Public Document Room or from the NRC's Agencywide Documents Access and Management System (ADAMS), accessible from the NRC's website at http://www.nrc.gov/reading-rm/adams.html.
Please feel free to contact me if you have any questions regarding this correspondence.
Thank you, Luis Nieves Health Physicist U.S. Nuclear Regulatory Commission Division of Nuclear Materials Safety Office: (630) 829-9571 Fax: (630) 515-1259 1