SEP 2 4,

Woodland Medical Group License No. 21-13255-01ATTN: Barry Samules, M.D.22341 West Eight Mile RoadDetroit, MI 48219

Gentlemen:

This refers to the routine inspection conducted by Ms. E. Matson ofthis office on September 11, 1980, of activities at Woodland Medicalgroup authorized by Byproduct Material License No. 21-13255-01 andto the discussion of our findings with Dr. Daitch on September 17, 1980.

The inspection was an examination of activities conducted under yourlicense as they relate to radiation safety and to compliance with theCommission's rules and regulations and with the conditions of yourlicense. The inspection consisted of a selective examination of pro-cedures and representative records, observations, independent measure-ments, and interviews with personnel.

During this inspection, certain of your activities appeared to be innoncompliance with NRC requirements, as described in the enclosedAppendix A.

This notice is sent to you pursuant to the provisions of Section 2.201of the NRC's "Rnles of Practice," Part 2, Title 10, Code of FederalRegulations. Section 2.201 requires you to submit to this office withintwenty days of your receipt of this notice a written statement or expla-nation in reply, including for each item of noncompliance: (1) correc-tive action taken and the results achieved; (2) corrective action to betaken to avoid further noncompliance; and (3) the date when full com-pliance vill be achieved. Be sure to address each-of these items inyour response.

a

Woodland Medical Group - 2 - SEP 2 4 1980

We will gladly discuss any questions you have concerning thisinspection.

Sincerely,

A. B. Davis, ChiefFuel Facility and

Materials Safety Branch

Enclosure: Appendix A,Notice of Violation

cc: Central FilesReproduction Unit NRC 20bPDRNSIC

OFFICERU .I _a l--Fal ---- ill ~ 9 ------------------------------

SURNAMEý 0 --- U15 ------------------ ---------- 1-----------DA E ................. --------------------------------------- --------------- ----------------

NRC Form 318B (R Uj) (1-78) NRCM 0240 *US. GOVERNMENT PRINTING OFFICE: -1979-289-237

Appendix A

NOTICE OF VIOLATION

Woodland Medical Group License No. 211-13255-01

Based on the inspection conducted on September 11, 1980, ii: appears thatcertain of your activities were in noncompliance with NRC requirements,.as noted below. Items 1 through 5 are infractions.

1. 10 CFR 20.201(b) requires you to make such surveys (evaluations) asmay, be necessary for you to comply with all sections of Part 20.

Contrary to this requirement, as of September 11, 1980, you failedto make such evaluations as were necessary to assure compliancewith 10 CFR 20.303, a regulation that limits the disposal of licensedmaterial by release to a sanitary sewerage system. Specifically,you failed to evaluate the releases of Iodine-125 to the seweragesystem.

2. 10 CFR 35.14(e) requires that sealed calibration or referencesources possessed pursuant to 10 CFR 35.14(d) be tested for leakageand/or contamination at intervals not to exceed six months.

Contrary to this requirement, as of the day of the inspection, youhave failed to leak test your 204 microcurie sealed Cesium-137reference source received on May 1979, from May 1979, to February1980. This is a period in excess of six months.

3. Condition No. 16 of your license requires that licensed material bepossessed and used in accordance with the statements, representa-tions, and procedures contained in certain referenced applicationsand letters.

The referenced application dated April 25, 1979, states in Item 10the procedures described in Regulatory Guide 10.8 dated January1979, Section 2 of Appendix D will be used for calibration of thedose calibrator. Section 2 of Appendix D requires in part, alinearity test be 'done quarterly.

Contrary to the above, a linearity test has not been performedsince April 8, 1980.

4. Condition No. 16 of your license requires that licensed material bepossessed and used in accordance with the statements, representa-tions, and procedures contained in certain referenced applicationsand letters.

Appendix A - 2

The referenced application dated April 25, 1979, states in Item 17,the procedures in Regulatory Guide 10.8 dated January 1979, Appen-dix I will be followed for area survey procedures. Appendix Irequires in part, survey with a G-M survey meter be done weekly inall laboratory areas and monthly in the RIA laboratory.

Contrary to the above, G-M surveys have not been made weekly of thenuclear medicine camera room and monthly in the RIA laboratory.

5. 10 CFR 20.201(b) requires that you make such surveys as may benecessary to comply with all sections of Part 20.

Contrary to this requirement, you failed to make such surveys aswere necessary to assure compliance with 10 CFR 20.301, a regula-tion that describes authorized means of disposing of license materialcontained in waste. Specifically, you failed to adequately surveyfor Iodine-125 in waste disposals from the RIA laboratory.

(.

M'DICCAL (Revised 8/78)

Ur

Lucausee yame Szd Adirega:

Licvise Contact: Y"~ cx,i -A le

License ui. 'at - 3 2-5S 0 1LaSt AMW~.t Ofid dAta:

Cat.gi'y __________________ e Priorv1: V AS

Inspec~ioA datm(s): C) a ,,;,6 y

page I of 12

12Anandix A

A2£ppendix C

t12 4peateiz ID

I we~ongeg-w -3 i3 5-53'- V ?C\C

of last &mandment.

Of Inspec~tion: UO4Otuel, YZiJ(A

JIiA Y W FINDICN= AND i'IO

t2 I k Wipl• ianrtCs, Clear 591 Issued

$4-M Neml Ol I mltr. Appendix At I Action on~ proylous nomcw.-11anc, Appendix I

t I Nonmmplilft"S, Ill Issued

K 2 Suplmimntal Infi, Wandix t

See basis tlo Appendix C or ittached um .

t'ni O cengs atelo•l r it .... . [to OChange Priority u: _________

t I Next Inspectlon data: 9 1

*~~ .... ... 4 ~

A N Lk CL, 1+ /W -i • D ',, e, ,=.==l ,= el I ýJ," .== e, NO=

A )el

-,t . ,,- --

-4 L-J • I~-J\,-

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LI () iII

mt*e aire"

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paqe 2 of 12

P872as - Mdr.MAKU INSPE NC FIND.=

qk.

f¶?~¶ LfinpuTI.., ID-nIw..

" zat-Acceptable (A) Noocog.a.ce, N,. .

1.40"' Dbresolwm veStucTue of oPAzit'UVoR as desctbM In Lie Cone d

L Licenset Inter"Al audits Lie Cond

Scope and froe4uency of audits as reQui4od?

cond•jc.• by ap;F prate persons? Recoursminutine? Reyiewe. by fr•al•ai•?t

Deficiencies ideni'tfied A c=rtcte4?

3. Tsnirnin and ouazlf aicktt! of tari Mel LIec ConE /

Training A esatnifing canducted as Mtuiped?Written A oral exuai conducted? Examinatimn

Mults reviewed by wflagwat? ,t

ZIstructions to wrbers per 13.12? 13.72

S

q

4. Rediatlop vretet~at~ orzeedures -Lie Cand

.4 ProCadwes available and lnlw.vem ? Identifyiw fldrOpnrit•ct, -al an. uo ! €v, .a S. C... . . .

* a.andl1inof patients receiving thertowtic, dos,? lover handling of cadavees?

-fe•i•ncy Oeocedures for "ils, aft?personnel Uncers.and proceowres?

j2A '-

C .C

Page 3 of 12

,7871A - Nveicai

- 6.NS M1 CaI LA !

SS. _Use f vrte'111s

Pro•url'•v t alnd use is ft"viged?Special ttsu (•,ly brtiakthw•• . leek Uss,OU) requ~ired?

Oose calibration checks Ptrfsw€?Posting I labolifnt a required?

Lic Co•d /(- '-~~ fu/cc

20.203

'79

6. Storlee of rate-ills

Raterial securned In both~ rustricted andutnrastrlct*9 artas? Adequately?

7. facilivies Lie Cwt K_

As 1esc1Wb In lic tang or applicatlio•?Miy canges made? AdequaCy?

mw= a WOA;

&L~A

in.

, r'ey attars I if t s adequ for

Zsti'v*eMt & mWea o0trRble? Wlfbr1"&d?Calibration adequate?

Lit Cm&d I-.

Mm a AMM8

>j&~4 ijv F~- s-~~6 ~ ~ / 6 ~. .. ~-1'~w- ~-'-C4

- - - .- a - w. -. .. ~ *. -

(

Pa p j. of U .Wsfto - gdsC.&2

!=3.riot sft transfer of riar.RLAWrlfItt. pntsdurts for pictk4p, receiving, 20.2$

opening packages?Survey of packages 'khen ratcetvl ? 20.205(c)(1)

Rteorts of survey of packages? 20.407(b)

Trainsfer of mater1als proper? Transfer 20.41, ..S91roc ? ts mintained?

'Aulftrized w~nr usedSinn bo7£ package libels prooer for packages on nn

, ,.DP.a, . . pacags W .•.ha.d? 71.5 . ... .. _. _. . ,M M. 2 3 a .jLPOL C .5

-~4 C i~tt't~a ,~'~- 3

Persconnel orwntoriin; ,ontro1s ade"qUae?

Exposure recorts (Nk:-4 or 5) mintltned?Available for wtloyet review?

S•urvtys c• *ndcte47 Adequate?

Aec.zriz of montorinuiuw'veys?

Levels In un tstr~ctal areas within limits?

A7cC~

20.101, 20.202

20.102(b). 20.401(a)

20.201

20.40120.1, 11l05

-e- -t'~ C-k

Airt-orn concentrtisons I% Msts•icad tries?

Exposures to miners?Posting of airborne radioactivity ars?

Survey , Man ltring adequate for airborne v.41,actvllty, surface Con aMinintlon? RacWrftsmIintan•td?

Bioassay=29 & ACCMa

20.10320.104

20.=(d)20.20120.401

0.

GX eý C--'t 'ftb

41tý U Cr A -- 1Z e5'1ý I ('Z a:t - 41

t'ý 4 ° 0 1 IA'clV*,CIX

Ie a

- a. - 0. * a * -. - ..

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Page 5 of 12

Win mad**~ica.l

- isnmmm rmv VUiTFR.L f-ZN

1.ffflue'nt controls. waste diiesma

Release of affluents controlled? 20.=0.2.0vast* disposals controlled? 20.301, 20.303, 20.304, 20.305

Procedures, rtord•- .Aintain"? 201401o Lic Cona

S trvw mde? 4deJut? 20.401

• I ii •.,•c. *..•,4. " • /$ ',y - CA/ • .

13. N•ficatitos Pi retorts

Ue Individuals. 1".13

OvexSuol-st, excesslyi levlus I COntr~IutIOnt, 20.403, 20.405Incidents.

pgsna"I elzo~sures and monltev1ng, termination 20.407: 20.408

Theft or lost of licunsed Uterial. M.-~-- Cz40• e

14. Ptstl•oa f notlies

Part 20, license I docuamen,. pv'ocindrw., 19.11(a)notict of violations posted?

NR-S posted? 18.11{€)

U Da a

Ml. _umer,"Ca.fits.e Ca",,le'':-Is

II1

.. 7i

6Z~1kCC•'•/if'•"• •-'k.

----------- mwmý

S -. - a. - .-. ~.. ~ -....

Page 6 of 12

MIC2A - 6"a

Ix

17. effort

.•.-i-w <•, _/ _A<_-..t., <z. a- -. -. A

-~t~ ~4 )J j..°

* 1 mceldets andU events

Any •nidet• of orfsaCiltrattmu,wt~axirmaton, lu. hot othewise

covaM4 by reports?

- -

. Page 7 of 12787103 - Hedical

INSPECTION ITES FINDING

3,9. Summary of Licensed Progra=

Kind of program; number of people; rate of use or quantitieson hand; places and frequency of use; type, quantity anduse as authorized; and in accord with procedure 78720B.

0o /46 r t-d - ::Fj /U !5

20. Source of Information for Items Inspected N

In accordance vith Items checked in Appendix 1).

C

page -Lo JZ

flPCIX A - MJeNUTAT OFW=PJM

MOTE: Bases for nonco•.1•ances to be -ucwnenreo here, not.' ~munder Notes & Remarks fOr eaech-individual item

p,~ ~ ~ ~~c t2II o €"Il- "

• .<• -- --•,. -ash t*• <A em 1.,c -i.• •;/ sTport It=

1 on -3 1 U

Ty" a/c

Repot It=' 4

10 a/c ,

- - ?.p,,rn/c•

~i aft-4J ~ ,'~ 7 '~ cyn.-&>~4 c,~

T•. n/c

VIA LJ'7iY 6'tt 2S //

iý .. .. , - .ý -ie 2i- '

10 o'1 ltX -. Lý) 1< 9VzAV E

Lie Cm& &-W~~t~c

"- • ,2-01 • " ... • ~. " -2• 3o •-.Z -

10 Cn

is 0 O 14 •.-L. 6 L / ~ - d,'-1-•_,.( c,: Z 6_,.LIc Ci I II

Type a/c ~ -* -~L' LZ&~~--

V

D

* fl. *

rpmx a(mmAnmz vm nprO ING & Page9 of 12

d .

.4dont1fication and 5sXflul of action taken~ StA tij

3g~t __________Type a/c: ______ Decribi:_______________

Report Wi: __ _ _ _ _ _ _ TOO a/c:,_____ Describe:_______________

Action taken: OE

Iapoo't mo: _ _ _ _ _ __ Tooe a/c: _ _ _ _ DesCribe:_ _ _ _ _ _ _ _ _ _ _ _ _ _

Action takem:

Report s: ____ ____ Type sic: ______ Describe: _______________

* cflon WWIe:

0

low% M: Type a/c:Action takn: WEN

* Q-

Page 10 of 12

APPENDIX D SOURCE OF INFOPMATION

.: ) 5ppropriate iteu

•'i .. Discussions with:

a. Hospital Administrator

b. Heads of Departments in which BPM is used.

-. Isotope Co=ittee Members

d. Radiation Safety Officer

a. Authorized Users

f. Physicians working under the supervision of authorized users.

S g. Chief Nuclear Medicine Technologist

h. Medical Technologist

- 1. Student trainees in Nuclear Medicine Technology

------- J. Others,; Specify ....

2. Records Review

a. Radiological Protection Procedures

b. Emergency Procedures

c. 3PM Receipt

d. 3PM Transfer

g. IPM Use

f. 3PM Inventory

g. Waste Disposasl

h. Instrumentation - Calibration,-Results, Schedules

I. Special Tests - Moly breakthrough, etc.

J. Leak Tests

k. Radiation Surveys

1. Personal monitoring

a. Effluent Evaluation

, -•a. Shipping Incidents

D. Notification and Report

p. Others; Specify _ _ _

e , Page 11 of 12

AMVICX C - &VPJhe(At~fY ~

ftD~sua occurrence. con~ditios,~ OtC

* Sails for change of' Categoy or Pruicrit

I3 nspector's gpff~ft

0

0

-

( (,

Page -12.. o 1 of

APPENDIX D - SOURCE OF INFOX.ATION(continued)

. Observations

a. Dose Preparation

b. Dose Calibrator Usage

C. Administration of Dose to Patient

d. Use of Instruments

a. Laboratory Facilities and Equipment

f. Others; Specify -- •A Ac

4. Independent Measurements

a. Direct Radiation

b. Smear Surveys

C. Dosizetric Readings, Where Appropriate

d. Others; Specify

010

Ap~penEdix 9 27%

License: Lice-DE No.

• ]10w-urP on Bulleti•s and Circulars

A. Lulletins sent for Action

2. i~u11EDi ~(s)._______________

2. Vritteiz response timely?

3. Vrittem response acceptzble?

4. Lulletii and response reviewed by appropriate licensee personnel?

5. information discussed in licensee's responuse was accurate?

6. Action taken by the licensee as required by bulletin and describedin licensee's response?

B. Circulars and Bulletins sent for Infornation

1. Circular and Bulletin )No(s). -ý1cj-cJ7t c~~

2. ]Received by licensee.management?

3. 1. review for applicability was performed?

4. For those applicable to the facility, appropriate correctiveactionsr have been taken or are scheduled to be taken?

(Use reverse side and additional pates for comments)

i

INSPECTION PLAN AN _____I___

PLANN1ING SHEET

License no:LI censeet:

Inspection lams Scheduled for Post-inspection Module no. 7" Tim InfotWspection status

Kanagement meeting - Entranceand Exit Interviews 373

InitialNinagement Meeting 30800B

Program requl rments.

Licensee Event Follovup 92700B

Followp o0Inspector-identified problem 92701B

Fo1lowup on Noncomplianceand Deviations 92702B

IE Bulletn/Inmediate ActionLetter Followup 92703B

Followup on - -. _. -

Headquarters Requests

Followup onRegional Requests 94?70S .

Independent InspectionEffort 92706B

Inspector Dispatched to Site - 93700B

Followup on Significant EventOccurring During Inspection 937018

a.

Cad3. If the licensee has no waste packages on hand to inspect, check

this line and send response form 2 if all findings are satisfactory

4. If the licensee has a package(s) available to inspect, performthe inspection and send response form 3 if packages are satisfactory

5. If deficiencies in the above are noted use form 4 in your responseto headquarters. Document below which licensee actions are neededto bring program up to requested level.