ML21281A211

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GL Report from Us Dept. of Health & Human Services, National Institutes of Health, Regarding Transfer of Devices
ML21281A211
Person / Time
Site: Catawba  Duke Energy icon.png
Issue date: 09/23/2021
From: Ribaudo C
US Dept of Health & Human Services, National Institutes of Health (NIH), US Dept of Health & Human Services, Public Health Service
To:
Document Control Desk, Office of Nuclear Material Safety and Safeguards
References
Download: ML21281A211 (7)


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Director, Office of Nuclear Material Safety and Safeguards ATTN: Document Control Desk/GLTS U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Dear Sir or Madam,

Public Health Service National Institutes of Health September 23, 2021 This is to notify you as per requirements of 10 CFR 31.5c (8) (ii) that on September 16, 2021, I was informed that NIH transferred the generally licensed source(s) listed below to the following licensee:

Eckert & Ziegler Analytics 1380 Seaboard Industrial Blvd Atlanta, GA 30318 State of GA License# GA742-1 Please contact me at (301)594-1303 if you have any questions.

Catherine Ribaudo Radiation Safety Officer, NIH Device Detail:

Beckman LS6500 Liquid Scintillation Counter (S/N 7066011; ID Number: 01074704).

DRS Clearance Record for Counter Type of counter:

LSC Manufacturer Beckman Model LS6000IC Serial Number 7066011 NIH ID Number 01074704 Originating Bldg TB4 Room 3N-27 Contact Person Bill Huang (36578)

Cs-137 Activity 30 micro-Ci 09-25-2004 Source:

Isotope Date (approximate)

Source Removed YES XNQf

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OEM paperwork is attached Disposition of source _______________________ _

Comments DRS-507 RevISCd 02J28/201 l

, Dlgtoly ~nod by Jameo M _,

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2342 1820000010011-2002100667

-;'"~M--8 Dale 2021 08 01! 18 !i3 61 -0,l'()(J' Health Physicist Date

SAMPLE ANALYSIS REQUEST FORM Date Submitted: ~/6 /1.,1 I Time Submitted:

f 2()() ""j Analysts No.1 2(-- /60~

Cmtomer Name:

f1A.ll ffcvt,,(.. I llu ~o,i1 (v.. 51 t8 I Organization: ;U <N3 Sample/Survey Location (Bldg/Rm):

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Survey Area Type (Circle One):

. Rostrlcted Unrestricted "Both_

1-0_1/

Applicable Limits:

2200 dpm/100cni2 I 220 dpm/l Oocin"l 122 dpmil 00cm2 I i QOO'ctpm/j(\\0cm1'240 dpm/lOOcm2 I< 185 Bq

  • 2000 dnm/100cm2 I 200 d_pm/io0cm2* I 20 dpniilOOcnil Io:=.

N~~ of ~p,e..s: _.t>..

No. o!~I?n~~ I..

R~ ~.a.mp~~?. ~~ ~

~etaµt Smear Pi:t4~t? Yes

~ NIA. '

Smear Swab Liquid Carboy Tank Mixed X-check Sealed Source b

Sample Air Urine Standards BkRd Other: Please list in the

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Description:==

connne.nt box bolow.

(Cheok.All ThatAw}y)

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Activation Radlonnclides:

ctaj / ~ l4lllll-Other: C.sJ t'3 cf

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(CIRCLE All That Apply)

Comments:

EXPEDITED *coUNT REQUEST (rl~ Notify Lap f~aonnel lmmediatelY. Wl,1e.n ~es ting Expedited Processing)

J~tiflc!lti,O,D,:

Date/flme Needed (Be speclilc):

THIS SECTION FOR MC.AB USE O?il,Y l

Imtrument Comrtcr:

Hidex GSS Data:

Serial#:

A 117222 B2120212 C21202S~ D 2180115 E2180116 F 2190058 1-13164 2-8722 (Qi.eek All That Apply) v Analysts Started Completed Data:

Date: 'f(, / 1, *2-l I Time:

\\ ~<-0 Date:

Time:

Mode Date

'I1me

.Anlllyst lnitlalll Customer Verbal Notification:

E-mail Hard Copy

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VerlflC!,ti9p:

Signaton, In Ibis box oon!litutoa a verlfloation ofthia.bill and all sllppO{tlng and attaclled doc~Uld"4'F.c ~~

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~~1.08,0614:32:54 DlvWon ofbdlation Safoty/Matcdal Cantiul llll.d Analysis Branch Rovlsed 2/17/21

Analysis Report Form AN21-1605 Equipment Clearance S/N 7066011 LSC Count All <MDA/MDCR All <1 000dpm/1 00cm(sqd) ~ + gamma Analysis Complete 8/6/2021

NIH/DRS Analytical Lab Measurement file: AN21 -1605 Lab Clearance HC.dat Valid Assay Measurement date : 8/6/2021 Measurement time : 1 :20:25 PM Template file :

Measurement Template Files Reader Calculation Program System Printer Group Group 1 Group 1 Group 1 Assay Default Default Default Definition Formula DEFIN E Rb= 55 DEFINE ts= 5 DEFINE tb = 20 DEFINE E = 0.439 DEFINE E2 = 0.78 Smear 5 minute - Clearance.par

-- General Data ---

Type : End Point, Time : 8/6/2021 / 1 :20:25 PM, State: Va lid Measurement 14 labels included, label No.1 selected Template loaded during measurement time : s:lmcab\\... lsmears\\smear 5 minute - clearance.par; Modified template file Data file : AN21-1605 Lab Clearance HC.dat-8/6/2021 / 14:06:38-Operator wa s Unknown User - Created wth Version 5.58 Template file : Smear 5 minute - Clearance.par-10/24/2020 / 11 :11 :57 - Created by Unknown User-Created wth Version 5.58 Hid ex 300 SL, Driver Version: 5.12, Device Serial: 2120254, Firmware : 1.44 Installed features: LSC, Externa l Standard,

Activity Type: Standard Counting Time : 300 s, Maximum Counts: 3999999, Ionized Delay: 10 s, Coincidence Time : 35 ns,

Delay Before Measurement : No Tray Size: 12x8, We ll Repeats: 1, Range Repeats: 1 External Standard Used : No Screen CPM: None ROI Number: 1

- ROl1 Free Channel Limits 5 - 1020, Type Beta Calculation Status : Valid Assay, Calculatio n Time : 8/6/2021 / 14:06:38 MikroWin, Version 5.58; License No.: 017578 Assembly Code A : 001F 0200 0000 0000 0000 FFFF Assembly Code B : 0057 FF3F FEFF FFCF FFC0 FFFF Operating System Name : Windows 10, System User : drsannlab Printer Name : ORS086_21_ 143

-Threshold Statistics-----------------------~

Set 1

2 3

Threshold Limits

+oo > >MDCR >= 12.7416 > <MDCR > -oo

+oo > >MDA >= 29.0243 > <MDA > -oo

+oo > >MDA-lodine >= 16.3354 > <MDA-lodine > -oo

_____________ --- Definition Statistics -

Calculated Value 55.0000 5.0000 20.0000 0.4390 0.7800 C3Iitratioo Clate =.ll1e 12, 2020 13KG) l\\fean = 55 q:m MIXR= 12.742 MDA=29.024 11,0A(Reg Gide 8.23 Tal:fo 3) = 16.335 Table arranged data Sample ID Position ID CPM CCPM TDCR DPM Chemi MDCR MDA MDA-lodine

Background

A01 57 1

A03 47 0

0.448 0

3.00

<MDCR

<MDA

<MDA-lodine 2

A04 49 0

0.480 0

3.00

<MDCR

<MDA

<MDA-lodine 3

A05 59 4

0.535 7

3.00

<MDCR

<MDA

<MDA-lodine 4

A06 57 2

0.470 4

3.00

<MDCR

<MDA

<MDA-lodine 5

AO?

52 0

0.479 0

3.00

<MDCR

<MDA

<MDA-lodine 6

A08 50 0

0.500 0

2.00

<MDCR

<MDA

<MDA-lodine

I BECKMAN COULTER..

ACCOUNT MODEL SERIAL NUMBER USN I H LS6000IC 7060828 5625 FISHERS LN ROCKVILLE, MD 20852-1798 CUSTOMER CONTACT PURCHASE ORDER PROPERTY NUMBER Kirk Hines Credit Card 301-443-11 01 AGREEMENT TYPE AGREEMENT NUMBER EFFECTIVE DATES 7/6/2021 to 7/6/2021 CASE NUMBER CREATED DATE/TIME CA-03526890 6/29/2021 2:00 PM WORK ORDER NUMBER COMPLETION DATE PERFORMED BY W0-03361845 7/6/2021 10:30 AM KENT BRIER

SUMMARY

OF WORK PERFORMED Reported Problem soruce removal Symptom Summary LS Counter decommission / source removal Problem Summary Remove source and decommission instrument.

CUSTOMER SUPPORT CALL WWW.BECKMANCOULTER.COM ID NUMBER 222907 INSTRUMENT CONDITION Down Resolution Summary Removed CS 137 source and ship FedEx to E and Z for disposal LS Counter Serial Number:

7060828 System ID: 222907 FedEx: 965943462097 RA: UWE25JUN21A Verification of Activity Source removal complete. Signature Attached SYSTEM VALIDATION : For Medical Devices - Regulatory requirements call for a final validation of instrument repair and system readiness. The final validation of instrument repair and system readiness can only be obtained through a successful QC run using the laboratory's quality control system. This repair record and the laboratory's quality control records comprise the quality documents associated with this instrument repair. Copies of these records may be required by Beckman Coulter or regulatory authorities to complete technical investigations or quality audits. We appreciate your cooperation if requested to provide copies of your QC data related to this repair.

START DATE END DATE DESCRIPTION HOURS RATE TOTAL LINE PRICE CUSTOMER CHARGE 7/6/2021 9:00 AM 7/6/2021 9:30 AM SERVICE TRAVEL 0.5 475.00 USO 237.50 USO 0.00 USO 7/6/2021 9:30 AM 7/6/2021 10:30 AM SERVICE LABOR 1

475.00 USO 475.00 USO 0.00 USO LABOR/TRAVEL TOTAL 712.50 USO 0.00 USO PART NUMBER PART DESCRIPTION QTY PRICE TOTAL LINE PRICE CUSTOMER CHARGE DE INSTALLATION Deinstallation Service Charge 1

2,500.00 USO 2,500.00 USO 2,500.00 USO PARTS/EXPENSES TOTAL 2,500.00 USO 2,500.00 USO TOTAL CHARGE 3,21 2.50 USO 2,500.00 USO Customer Call Originator: Kirk Hines echnician Name: KENT BRIER Name of Person Signing Service Report:

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Customer Signature Technician Signature Total is an estimate only and does not include applicable sales tax and shipping charges.