ML20054A483

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IE Insp Rept of License 04-00181-04 on 780426.Insp Findings: No Noncompliance Noted
ML20054A483
Person / Time
Issue date: 06/06/1978
From: Book H, Zurakowski P
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION V)
To:
Shared Package
ML20049A151 List: ... further results
References
FOIA-82-11 NUDOCS 8204150490
Download: ML20054A483 (14)
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W ALNUT CREFK. C ALIFORNI A 94596 INSPECTION REPORT NO. ~ Attached []AppendixA Vef< o n s /t d.n e n, sbf: o.s /h,,. h / W. l< ri. re >~a C,~+e//e aN/, [ ] Appendix B [ Q Appendix C L,. s th,y le s - C. A 700/3 Telephone No: [] Memo License No.o 4 -gosS/- 6 V Last amendment & date:7F 57. Ad //74 Category: 6l & Priority: 3 as of last amendment. p d.( /17s Type of inspection: s " + = es.' c e d Inspection date(s): M> p

SUMMARY

OF FINDINGS AND ACTION [tdononcompliance, clear 591 [ ] Noncompliance, 591 issued [] Noncompliance,AppendixA [ ] Regional action [ ] HQ action [ ] Action on previous n/c, App B []Supplementalinfo,AppC RECOMMENDATIONS See basis in Appendix C or attached memo. ~ [ ] Change Category to: [ ] Change Priority to: []Nextinspectiondate: A % 19TD PERSONS CONTACTED Mh l hp.c. s T l-. LU. (wihw, v,, f%,_ W r1 0 l > le d, C hie-( y ar. In y t4p d.e.;,, a 5p' - v c..e ?c n3 g

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%0 i%cim /, n< m : s f-m Je-f4 S6e rlt r Sic., / 6'e.' <,s e e T;c.4,>.<.a s 3 Inspector: J. AAI4 wn d' 30 N If 7f h o Approved: 8204150490 820216 PDR FOIA IE:V Form 605 NELSON 82-11 PDR 1

Page 1 of _7 IPCPEITICri PLNJ No RJORT FAM Plan approved: Date: Licensee: V N-Mr%' feI. b N - License no: 67 - do II/ ' Oy a j Inspection Ite'ms 5h ul for Post-inspection Module rn. 766 Time Info Managenent meeting - Entrance and Exit Interviews 307038 f IEWDDI V -gi.i Initial Management Meeting Progra:n requirements, ' MC 28_ % 7 (Ot3 Licensee Event followupt.. '927008... Fo11cwp on.. Inspector-identified proble :s 927015 ~ -- Fo11cep on tioncompliance and Ceviations -- 927028 IE Bulletin /Ir=ediate Action-' Letter Followup 927038-~ .z. Followp on Headquarters Requests 92704B Followp on Regicnal Requests - 92705B Independer t Inspection E Hort V g{gi5 j (EWns/ Inspector Dispatched to Site 937008 Follo w p on Significant Event Occurring During Inspection 937018 IE:V Forn 617

( cI IfGPECTICri TJJOiT fMTER page 3 of 18710s - redica: NIEAS IriSPECTED A*O FIfCIfMG Licensee: 1 /.,4. //r><,n isI C (7 Liceise no: d/-tts f /~ cW' A enc ent no: b7 9 INSPECTION ITEMS CRITERIA FINDIh5

1. Orcanization y

Structure of organization as described in v 3 Lic Cond requirer.ents? I S E " #*s.D# $ c y c q cd v ] M M**~*'- Notts s RruRxss g,3 t,-<J u av A4 ,i.~,y-scu,~ /. - & G-ik.3& % ~-c i w.z-r<-~ l~' -+v lay i4 M o. c. <%%K- - g ca. i,..,, T*< iw.- .bc w. A

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2. Licensee internal audits Lic Cond 0 -1<'

Scope and frecuency of audits as required? 7 #5 Conducted by appecpriate persons? Records ef 6 maintained? Reviewed by management? qc> Deficiencies identified & corrected? cf e) NorE: s Rrnaxs: %w 514 th ll S'C h4 b '*" 9% "Yl~l~ s M^ hc A *4.v~*"^ . - > > ~. < * <^M QL, & ,i,.L-enf-Q ft G ry y > 1" A 2"V y ,,,,,~.c A q ,.c ~, st~-4 n s-

3. Trainino and cualificatien of cersennel Lic Cond Training & retraining cenducted as required? g o Written & oral exams conducted? Examination 9 pp results reviewed by management?

~ ' ~ ' ' ' Instructions to workers per 19.12? sf r j 19.12 0 f D'= . d i.i - r3 -tR n " ' * * " " ' T2 tF;.> f.i A-r a 4 6:, jn. sW % ~ U.-< L-~ He-am., L. & k ihs-D % l' T< A "'ry.-*< ys s rts. R ---< r-A-.wyc. m /2. s c s -. > + ~ ~ w^~) e- .f WLh 6%g w . t~a A.-o en--1-< o-a w. w.e ,w A ru w m a I c m.L 4. -( j 9,~s- ..:1 sb w' rt Hi-rg.sE 'h e-a

4. Radiation oratection procedures

.Lic Cond (I Procedures available and ieclerented? Identify y S radiophart:iaceutical and cose(s)? Cover handling of patients receiving trera::eutic 'I #3 doses? Cover handling of cadavers? -1 *' S Emergency precedures for soills, ete? q45 Fersor.nel uncerstand procacares? NC'7ES s REXARxst N. (L L C ,n t/ f/s "I I[v --< b b 'C#**** .#%.:y i c.- ~d in< w ,i-1. ,a ws 10 <'d g +- S-{'~i' .> + G.s' f (,a,_ n" IE:V Form 624A

f ( , If;SFECTICri REFCRT f.U*BER Pass 4 of 18710s - redic21 AREAS IriSPEC1ED RO FIfCit'GS Licensee: U II. /h -r6IoI, I-N License no: N-t' e/ 8 l'dAmendment no: N INSPECTION ITE'i CRITCRIA F!!o!?i3

5. Use of caterials Lic Cond Procurement and use as required? 'TES 4.g Specialtests(molybreakthrcugh,leaktests.,,,pj etc) required?

I O Dose calibration checks perfomeo? 1 Posting & labeling as required? y c'j 20.203 LA~. -4: > d*A A -* ~~ J A * * ~'Y r] ~ sorts s ar uxs (gtz. tt +-c i-ven c{ 'uda r-e..-ef Q k (4 5 C CA-. -{~~ C ,;tc of, e.H e{ l1+J- <r V

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6. Storace of raterials r-h(~

20'.207 Material secured in both restricted and ',/ 6 unrestricted areas? Adequately? g s' s-es m O -** *** W *"b' .-)m. g ,w c, $-. sorts a atxults e p, a g,,,). a p /u

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7. Facilities Lic Cond

'N ..*c:<. As described in Itc cond or application? 'f 'S I Any changes made? /e's-Adequacy? 'l A S s scrzs s sinutzst $- M*wd' lt.m ,.s m w E EI cA.. -HA u Qxf:k Am fu.- J-s -f %&~~,"'W 'Qlbn 1 3 <=^ *- J,w p+J G'~~#'^~l k.,cr g ,u e, ~& c ".a.f3".,~.'.a" =- ({_~~ x p w -> w w f 4./ his 90'. Wa-$44 '4 3 IMU

8. Instruments Lic Cond
  1. '~77 Survey meters & instruments adequate for program?

Instruments & meters operable? Calibrated? g / S __'o Calibration adequate?

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s-s Page 5 of ifGFECT10f4 REKAT f.UT,ER 1 m os .<*edien AREAS !fGPECTED A'O FlfalfGS d dN NU'IP-l.-- /7 + License no: cY -10 /5/- ("/ reendment no: Licensee: INSPECTION ITEMS CRITERIA FifiO!!.G s N

9. Receipt and transfer of material Written procedures for pickup, receiving, q 20.205 I

p.: open[ngpackages? Survey of packages when received? q < './ 20.205(c)(1) Records of survey of packages? 61 ** > 20.401(b) Transfer of materials proper? Transfer q < 5 30.41, 30.51 records maintained?

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Authorized centainers used? Shiccing papers 71.5 & package latels preper for pactases on nano?ic'$ I+r-* y$h, Ra_,.,i;. u. $ A. n ~.- - F. tf-* % ~ - w f*

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10. Persen_n h tection - external Personnel monitoring centrols adequate?

q <$ 20.101. 20.202 Exposures minimized?

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Esposurerecords(NRC-4or5) maintained?sfr) 20.102(b), 20.401(a) Available for eeployee review? tl < > Surveys conducted? Acequate? 96 , 20.201 Records of monitoring 7 surveys? 'JO 20.401 Levels in unrestricted areas within.1imits? *(g 20.1, 20:105 '~s sorts s st w xss p p.'p w o p ',,y n,,_ cu gzA k-y.e. .C y - - ej' "m+ h.i. - G 1% 4'< 4s:~ f%.:t:;., %. nca., el m p< J<<. ik. w~ r t 4 % -ryu -s - k--l < - - ~ ~ oa w "~ 4, \\ QL ig@ J-c.pm s -f ^jfD '~m N* ;' - N

11. Personnel orotection - internal Airborne concentrations in restricted areas? '"It" 20.103 Exposures to minors?

'M 20.104 Posting of airborne radioactivity areas? W6 20.203(d) Survey. monitoring adequate for airborne radio-20.201 20.401 activity, surface contamination? Recordsy.J -*ms.' maintained? y e. ,,;,3yt,t. .t m ts s si m xss ~fk (w_j p_,_ ' '"J

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IfiSPECTICtl FIPCRT r. UTER ' Page 6 of 7e710a - nadie.n1 AREAS !?tSFECTG AfD FltO!t(GS Licensee: V. Il /47.T2'kri - L. Id - License no: 6#/- CiS' b # Iteend. ment no: N IfiSPECTIO1 ITEM CRITERIA F1(D!hG

12. Effluent centrols, waste diseosal fi<

Release of effluents controlled? qq 20.105, 20.303 g Waste disposals controlled? cj <") 20.301, 20.303, 20.304, 20.305 Procedures, records rnaintaired? Lj (f 20.401, Lic Cond Surveys made? Adequate? $l c"3 20.401 i LM *"5 QL {..,,*M,w'-< ~'* s% /s W s' ~} sorts s six;Jtxst p,. p.a. m..f-u--~ M ..,.n, s ,u.-..,'~~~a) )~s.,1 r- '1"p s.-,, f.u, ( j&M C' %Jv=-*)c ) W @'"o ' l'~ s*?L f~2 7~ *A gupyJx y g t-o f5.,< ll sw &~ u-~~T t "~* pt ry - h< r. ,\\

13. tiotifications and rererts
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1 To individuals. er N 19.13 Overexposures, excessive levels & concentrations, 20.403, 20.405 incidents. Personnel exposures and monitoring, temination 20.407* 20.408

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' reports. Thef t or loss of licensed caterial.,,A 20.402 p gz q c a j: f,l $ L T~ a' m A<-n A

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14. Postino of notices d.k Part 20, license & documents, procedures,t p 19.11(a)-

notice of violattens posted? ~" ~ NRC-3 pasted? g<J 19.11(c) gt.lt. f.rf- ! 'l g nt<~~< N y*d'W ly N*

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15. Other license conditions Lic h

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e r-( a IriSPECTICt1 FiPCRT IG3ER Page 7 of f 7871CB - Meil:a1 /REAS IfiSPECTE # C FIf0!fSS Licensee: License r.o: A.t.endt.ent no: It45PECTI0'4 ITEMS CRITERIA FIf; DIM i

16. Confir story reasurerents

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17. Indeoe ident inseeetion effort c-R' G

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18. Incider.ts and events c>W Any incidents of misac. ministrations, contamination, etc. not otherwise l

covered by reports? f $ (,; Q fu'.. % g $4 m -C* rr,$t k Yu' dt u b N W } (Rv-r.som$% e' 'a fu- '-< m pg pg 1% )<. J^ pq:. t'~s-% IE:V Fonn 624E l

Fage 3 of 3 ' If6PECTION FEFCRT fu2ER APPDClX C - SUPPtS'BITARY !!.70 0Y dC / 7l-C Y Licensen: if A /-l.- W v b d -' b b License no: j [ ] Uncorrected / repeated nonccmpliance ( ) Unresolved items [ ] Unusual occurrence, conditions, etc [ nspector's c:crants [ ] Dasis for change of Category or Priority e t^. 1 ~ s*f l'* "'f"O " M ). u. w.-l- .p ~Gd i em La e

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Radinicotope M1111 curies 3 177.477 H - as-labeled compounds I4 21.179 C - as labeled cempounds 22 0.410 Na - as labeled compounds I. 32 13.000 P - as labeled compounds 36 0.200 C1 - as labeled compounds t as - Ca - as labeled compounds 4.000 I Slcr - as labeled compounds 5.875 54Mn - as labeled compounds 0.300 i 57Co - ac labeled compounds 0.006- { t pr 63 11.0 Ni - as labeled compounds 99mTc - as labeled compounds 150.000 125I - as labeled compounds 10.205 131 1 - as labeled compounds 17.000 111In-as labeled compounds 1/000 "^ " II3 25.000 In - as labeled compounds 35S - as labeled compounds 0.2 6% ~ I IE:V Torm 620 t-e. e,,e -w--em- -+-n,,,,m ---,,,,-,-ene.,w,- p,- p--,w,,,r.--. -m.g,w.e_.ma.,,,,,,-u.n,m. .,,,,,n._,-,,_ye,,,mgy,.., y,,--,,1 ,,m-, s. ~&y,

o ( i f'eb.OaSo$bfg ( o c: s s' Q_, 67 a - as labeled compounds 4.000 C 201T1 - as labeled compounds 1.600 75Se - as labeled compounds 2.000 133 10.000 Xe - as gas 125 1 - 1;orland scaled cource 200.000 63111 - IIcwlett Packard G.C. sources 2-X 15.000 90Sr - Radiochem. Center ?!-SLC-7 Source - 10.000 90Sr - Opthalmic Eye Therapy cource 24.000 311 - Varian G.C. source 150.000 eM *'88P > se ni =

( ' aSe _( of _} c t l?BPECT:Cil P2PCAT TMER APPEfS!X C - SUPPLD' cit /RY l'.'FD Licensec: License no: [ ] Ur. corrected / repeated nonce.Tpliance ( ) Unresolved ite:ns [ ] Unusual occurrence, conditions, etc [.f fnspecto'r's corcents [ ] B: sis for char.ge of Category or. Priority -[/g ~.,L. A.M d.< % w d O M [ a A pNmb f 'l I'l)) GM M 3.1 No. of 3.2 No. of Tests Radiopharmaceutical Patients or Images l 131-Iodine Iodide 368 1394 IllSA 10 10 Rose Bengal 5 15 Ilippurate 640 1280 123-Iodine 342 1026 1 99m-Technetium Pertechnetate 12 29 Sulphur Colloid 1082 9608 l MAA

734, 2936 i

DTPA 4231 16,035 i Pyrophosphate 933 10,393 DMSA 32 48 IIIDA 36 174 51-Chromium Sodium Chromate 16 16 Albumin 5 5 ."f iS ~ 111-Indium Bleomycin 13 48 DTPA 342 684 I 57-Cobalt Vitamin B12 67 134 133-Xenon 191 1528 i 75-Selenomethionine 3 6 67-Gallium 803 2766 --r-- 201-Thallium 160 1244 i a 3.3 Number of in vitro tests done for each radiopharmaceutical used: Radiopha rmaceut i cal No. of tests 125-Iodine 18,235 57-Cobalt 1,172

t-II. TIIERAPY 131-Iodine Iodide: 13 patients treated for hyperthyroidism '4 patients-treated for thyroid CA SCOPE OF SERVICES 1. Number of hours per week of Nuclear Medicine Ser'vice: 40 hours 2. After hours, veekend, and emergency services: No regular standby or on-call service. Weekend and holiday services not provided. 3. Sites: 35 different locations Personnel: 160 persons using radionuclides 4. Radiation Safety Officer is L. W. Wetterau, Jr. lie reports to the Chief, Nuclear Medicine Service 5. No. of ambulatory (OPD) patients who have had nuclear medicine ~ services: 4207 ambulatory patients 6. Of the patient load, 38 % is outpatient. 7. Radiopharmaceutical uses covered by an FDA IND application are: a. IND 12,989, as of Nov. 26, 1976, issued to Medi-Physics, Inc., for MPI !!cpato-Biliary Reagent b. IND 12,784, as of Sept. 17, 1976, issued to Manuel Tubis, Ph.D.. Nuclear Medicine Service, for I 131-Labeled 1-Bromometronidazole. i A copy of this IND, the subsequent correspondence regarding additional ( data requested, copies of the " Protocols for the Use of 1 131 Labeled Bromometronidazole for Visualiaing Amebic liepatic Abscesses," and for the " Preparation etc.," are herewith furnished - see enclosure. I j Indium 111-DTPA, Medi-Physics, Inc., Phase 3, for intratbecal use c. l in cisternography. [ l 1 '^ ~ Livercolloid ReagentTM (Stannous chloride), Medi-Physics, Inc., d. l for lymphoscintigraphy. e. Kidney Scintigraphin, (DMSA), Medi-Physics, Inc., "for evaluation of - ~ ~ ^ kidney parenchymal morphology." f. Thallium chloride T1 201, New England Nuclear, for myocar'ial d perfusion imaging. l l L

S. NUCLEAR REGULATORY COMMISF "f1 ( 'FFICE OF INSPECT 10N AND ENFORCL HT s REGION V Report No. 81-01 License No. 04-00181-04 Priority 3 Category G1 Licensee: Veterans Administration Center Wilshire and Sawtelle Blvds. Los Angeles, California Facility Name: Inspection at: Wadsworth Hospital Inspection Conducted: May 7, 1981 ,,i Inspectors: 4 Ewc4. G~. S. S enc'er, Ch' f, Division of Technical Inspection Date Signed C b iSYEJ n H. E. Book, Chief, Radiological Safety Branch Date Signed fYrst WSff/ R. D. Thomas, Chief,11aterials Radiation Protection Dcite Signed /, h/$;ggy' h.Sffy' % L. Camper, Materials Licensing Branch, NRC Headquarters 'Dat6 Signed na su re B. A. Riedlingerg Radiation Specialist ~ Date Signed Approved by: ,4_Mht/4 $'/IS/'f/ R. D. Thomas, Chief, M terials Radiation Protection ' Dhte Signed [ / Approved by: M c. H. E. Book, ' Chief, Radiological Safety Branch Date Signed Summary: Enforcement Conference on May 7, 1981 (Report No. 81-01) ltems discussed at enforcement conference: (1) Enforcement options available to the NRC, (2) Recent changes in NRC Enforcement Policy, (3) Items of noncompliance associated with last flRC inspection at Wadsworth Hospital, (4) Compliance history, (5) NRC actions to be taken in the present situation, and (6) Possible future actions by the NRC. The need for increase management control of the radiation safety program was stressed, as was the need for license amendments to reflect the current program. The enforcement conference involved a total of five hours onsite by five NRC representatives.

( ( DETAILS 1. Persons Contacted Mr. Lu M. Mackman, Assistant Hospital Director (Acting Director) Dr. H. Earl Gordon, Chief of Staff Mr. Leonard Wetterau, Nuclear Medicine Service Radiation Safety Officer Dr. Ralph Mackintosh, Radiation Therapy, Radiation Physicist Dr. Zbigniew Petrovich, Chief, Radiation Therapy Service Dr. Mm. H. Blahd, Chief, Nuclear Medicine Ultrasound Service Mr. Jim Smathers, U.C.L. A.

===2. Background=== This enforcement conference was held between NRC and licensee management representatives to discuss the findings of a special safety inspection conducted on December 8,1980 through December 11, 1980. The inspection had been conducted in conjunction with allegations by a former employee about the use of sealed sources at the Veterans Administration Wadsworth Hospi tal. During the inspection, four items of noncompliance and two deviations were identified. These items of noncompliance were described in Report 80-02 which documented the inspections conducted during December 8-11, and 17-18,1980, and in a Notice of Violation dated February 25, 1981. The licensee responded to the Notice of Violation in a letter dated March 26, 1981. The licensee's response was discussed during the enforcement conference. 3. Items Discussed During Enforcement Conference The enforcement options available to the NRC were discussed, and the recent changes in the NRC Enforcement Policy as stated in the Federal Register on October 7, 1980 were reviewed. The hospital's compliance history was discussed; and the items of noncompliance noted during the special safety inspection of December 8-11, 1980 were reviewed. Several specific areas of concern were addressed: (1) The fact that a possible overexposure was not reported to the NRC, (2) the apparent lack of administrative control over the radiation safety program, and (3) the fact that the Radiation Physicist was required to function as the Radiation Safety Officer for radiation therapy implants. Following the discussion of these areas of concern, Mr. Camper outlined changes that are necessary so that the license reflects the actual radiation safety program: (1) The responsibilities of the Radiation Physicist need to be clearly stated in a license amendment application if he is to function as an Assistant Radiation Safety Officer. (2) One person must assume overall responsibility for the radiation safety program. (3) Changes in radiation safety procedures need to be submitted to licensing for incorporation in the license. ( The licensee was informed that their reply to the Notice of Violation will be acknowledged with the understanding that a license amendment will be submitted to document the current radiation safety program. Licensee representatives stated that the required amendment will be prepared and submitted to NRC's Licensing Branch for review. At the end of the meeting possible future enforcement actions were discussed. The licensee was reminded that the failure to assure that the license describes the actual radiation safety program could result in more serious repetitive items of noncompliance. Repetition of items of noncompliance may result in the issuance of a civil penalty. ..}}

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