ML20195C767

Matls Licensing Package for Amend 6 to License SNM-1996 for Tenet Healthsystem MCP,L.L.C.Control:126699.Portions of Encl Withheld

ML20195C767
Person / Time
Site:	07003077
Issue date:	04/28/1999
From:	Tara Weidner NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20137S710	List: ML20195C767
References
126699, NUDOCS 9906080297
Download: ML20195C767 (20)

Text

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NRC PDRM 378 C]u.s. NUCLEAR RE!ulAToRYPAGE CoMMtsSloN 1 OF 1 hPAGES.

Am:ndm:nt No. 06

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MATERIALS LICENSE l

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1.' Tenet HealthSystem MCP, L.L.C. ._ 3. Ucense number SNM-1996 FQ-d.b.a. Medical College of Pennsylvania Ho'sditaF1 F

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2. 3300 Henry Avenue p 4. Expiration date Not Applicable Philadelphia, Pennsylvania 19i29 5. Docket No. 070-03077 l Q Refwen r

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In accordance with the lettbidated Marc'h 25,'1999/this~ license is hdreby termiriated. <

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For the U.S. Nuclear Regulatory Commission Originalsigned by Tara L. Weidner Date Anril 28.1999 By Tara L. Weidner Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety Region i King of Prussia, Pennsylvania 19406 9906090297 990428 PDR ADOCK 07003077 C PDR __

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O O April 28,1999

. Docket No. 070-03077 License No. SNM-1996 Control No. 126699 Yvonne Zavada Chief Operating Officer Tenet Health System, LLC dba Medical College of Pennsylvania 3300 Henry Avenue Philadelphia, PA 19129

Dear Ms. Zavada:

Please find enclosed Amendment No. 6 terminating License No. SNM-1996 as requested by your application dated March 25,1999.

Your cooperation with us is appreciated.

Sincerely, Originalsigned by Tara L. Weidner Tara L. Weidner Health Physicist Nuclear Materials Safety Branch 1 Division of Nuclear Materials Safety

Enclosure:

Amendment No. 6 cc:

Theodore Villafana, Ph.D., Radiation Safety Officer ML10

E o o Y.Zavada 2

- Tenet Health System, LLC s

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l DOCUMENT NAMEi B:\DNMS Documents \Lic Cover Letter \LSNM-1996.a.wpd 87160185 ;

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OFFICE DNMS/RI / glN DNMS/RI l l l NAME TWeidnet4WV l DATE 04/28/99 04/ /99 04/ /99 04/ /99 l OFFICIAL RECORD COPY L

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. Materials License Terrninntion/ Retirement Form l

O' 6AJM -/ % O DOCKET #(s): 070-03077 l LICENSE ADDRESS: #(s)/14M EXPIRATION DATE: 4/30/O 2-l AAm HenrLlftrC . DATEOFCONTACT3-/hdr/9 7 l +htJB . PH1 IRI 2 M CONTACJED BY: \/vonne 'Zavqdow TITLE: L' O O TFJ RPHONE:216- 241- 6OMo LICENSETERMINATED:

LICENSETRANSFERRED:

LICENSE TRANSFERRED TO: Name:

Address:

Telephone:

BASIS FORTERMINATION AND/ORRETIREMENT:

TERMINATION DOCUMENTATION

1. License tennination meets Type I criteria: Y2di_

_ Licensee used sealed sources only and the most recent leak test demonstrates that they did not leak while in the licensee's possession

. _ Licensee used radiosctive ir. :.;.el with Tm 560 days and it has decayed to less than the activity in 10 CFRPart 20 At =adiv C

2. License tennination meets Type II criteria: <Y_N_

_ Licensee pa==a===A and used only sealed sources but cannot demonstrate that the sources did not leek while in the licensee's possession

_ Licensee possessed unsealed radiosctive material with T ni s 60 days but the maximum activity authorized under the license has not decayed to less than the quantity specified in 10 CFRPart 20, Ap=adiv C

_ Licensee p-:+Eex-i unsealed radioactive material with T ni > 60 days but 5120 days.

_ Licensee pone *=aed "C or 'H but the total activity (s) and 'use authorized under the license f warrants decommissioning under Type II (describe rationale above) l Rev.O, December 1996 F-1 NUREG/BR-0241 26699 0FFICIALRECORDCDPY

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3. License termination meets Type III criteria: Y N ._ ,

_ Deammi==ioning qualifies for a categorical exclusion under 10 CFR 51.22 (c) and

_ Licensee will decommission its facility in acccadance with the NRC's criteria for unrestricted use.

4. License termination meets Type IV criteria: Y_N

__ Deammissioning does not qualify for a categorical exclusion under 10 CFR 51.22 (c) i

__. Licensee will decommission its facility such that residual radioactive material may remain in excess of NRC's criteria for unrestricted use.

5. Terminationsurveyrequimi: Y _ N _'

_ Termination survey submitted by licensee

_ Termination survey satisfies NRC survey requirements

6. Form 314 or equivalent mihmitted: YdN__

dtaff verified disposition of sealed sources:

or amer:nled radioactive metain!

by:

rietter from Form 314 recipient

_ call to Fonn 314 recipient

7. Licensee transfer records dien=*A in 10 CFR Parts 30.35,30.36, f 30.51; 40.36,40.42,40.61; or 70.25,70.38,70.51 Y Z N ._.

_TpUSNRC

_Vro individual assuming responsibility for the license, with a copy of the cover letter to NRC

8. NRC closeout 6:r+ Mon rqsd: Y __ N _V

_ Closeout *=r+ Mon performed:

on:

!=r+:ter:

9. Closeout survey performed: Y __ N _

on:

by:

Licensing assistant completing form: ,

Date:

or License reviewer N -lY~N completing fo - Date:

Branch Chief: Date:

NUREG/BR-0241 F-2 Rev. O, December 1996 e

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,e l-MCP Hahnemann Oersity 0 Opeisted by 4

I Radiation Physics & Safety Department MCP Division univansive 3300 Henry Avenue . Philadelphia, PA 1912S1191 TEL 215 842 6588. fax 215 843 5734 www.mcphu.edu April 21,1999 U.S. Nuclear Regulatory Commission 475 Allendale Road King ofPrussia, PA 19406 '

Attn: Tara Weidner  ;

Re: NRC License SNM-19%

Docket # 07003077

Dear Ms. Weidner:

As per your request, enclosed is our letter and attachments of November 11,1997 concerning the status of the above-referenced nuclear pacemaker license which we are terminating.

' urs 19 y, N,

Theodore Villafana, Ph.

Radiation Safety Officer TV:lkf i

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)abb99 APR 2 31999 0FFICIALRECORDCOPY ML 10

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l 3300 Henry Avenue Phdadelphia, PA 19129 l 215-842-6000 ALLEGHENY UNIVERSITY IiOSPITALS MCP November 11,1997 l

Michelle Beardsley '

Nuclear Regulatory Commission 475 Allendale Road King of Prussia, PA 19406

Dear Ms. Beardsley:

The foll implanted in[,owing is submitted 7 who passed as aaway follow-up

{ to ourjtelephone report on the stat Summa

• l assed away and was cremated. Pacemaker, however, was explanted '

efore cremation. The physician designated to monitor pacemaker status was not involved in care of patient in his last days. Physician that was involved correctly advised funeral director not to cremate pacemaker but was not aware of the proper disposal pathway and further advised funeral director to bury it.

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Funeral director, in order to dispose of pacemaker in a manner he felt to be the quickest and safest, placed said pacemaker in casket of another individual about to be buried ratMr than wait the 3-4 days before it would take the ashes of. to be r.uied from the cremation service.

Status of pacemaker was being monitored every 6 months with patient's designated  !

physician. Last date was June 3,1997 (supplement A), when no change in patient's I status was reported.

Report

. Pacemaker ID:  ;

Coratomic Model C-101 Serial #.

Implanted:

Patient was admitted to St. Mary's llospital for care relative to multiple sclerosis complications and subsequently expired at hospital.

• Patient:

Expired on: C i l

Expired at: St. Mary's llospital l Langhome, PA  !

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llad pacemaker explanted by Mr. Jack Bonner, Supervisor of funeral parlor on:

Was cremated on: C Ashes were buried at: Beverly National Cemetery i)'

Beverly, New Jersey Alleghongealth 2fducation and Research Foundation Allegheny General Hospital Allegheny integrated Health Group Allegheny Uruversity of the Health sciences Allegheny UnsverSity Hospitals e Allegheny University Medcal centers e st Chnstopher's Hospiial for Children

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- Page 2 Michelle Beardsley e

Funeral parlor handling remains was as follows:

Dougherty Funeral Parlor 2200 Trenton Road Levittown, PA 19056 Funeral parlor staff had been told that burial would be best for the pacemaker by Dr. Anil Deshponde, cardiothoracic surgeon, who had been called in as a consultant at St. Mary's Hospital.

. To expedite disposal ofpacemaker, the funeral director (Mr. JefrStroup)

- decided to place it in the casket of another individual about to be buried since according to him, it would take 3-4 days for ashes ofdeceased to be retumed. -

Funeral director felt this was the fastest and safest way to dispose of pacemaker. (Attestation attached as supplement B).

Pacemaker Date of burial: finally { buried 7 in casket as follows:

Place of burial: Our Lady of Grace Cemetery e

PlotID#:

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Patient's physician following pacemaker status was:

Rajnikant Shah, M.D.

Medical Arts Building, Suite 1 1 1723 Woodbum Road

' Levittown, PA 19057 This physician was being contacted every 6 months. Last date of contact was June 3,1997 when no change ofstatus was reported (see enclosure A). He was not involved in care ofpatient during this hospitalization (which was for multiple sclerosis complications) and first found out about patient expiration from Dr. Paul Weiser, the Radiation Safety g Officer, from St. Mary's.

i All other pacemaker patients are contacted directly. It was, however, felt at the time ofimplant for this particular patient the attending physician -

was a more reliable contact.

The original vendor ofpacemaker was:

Biocontrol Technology Corp.

Indiana, PA They recei a call fro Mary's Hospital on demise of (No identification on(person calling i Vendor called hospital to etermine the name of radiation safety officer for

. purposes of sending a shipping container for the pacemaker. The vendor was told that Dr. Paul Weiser was the RSO.

e Dr. Weiser, radiologist and Radiation Safety OfYicer at St. Mary's received the shipping box from the Biocontrol Technology Corporation. However, it had no designation as to what it was for. Dr. Weiser called the Biocontrol Technology Corp. on October 8th and was informed that the box was for the retum of the pacemaker for a patient that had expired. Dr. Weiser, after some

' investigation, identified patient and reported to the Biocontrol Technology I

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t Page 3 Michelle Beardsley j i

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Corporation on October 13,1997, further details and the fact that the pacemaker would not be shipped back since it was buried. {

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The Radiation Safety Office AUHS/MCP Division was notified of patient's death on October 13,1997 by the Biocontrol Technology Corporation and was given the contact person name of Dr. Paul Weiser. Staff person receiving telephone call attempted to contact Dr. Weiser to obtain further information

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but was told the doctor was on vacation and to call after October 27,1997. i Call was made November 3,1997 and the Allegheny RSO was informed for the first time on that date of pacemaker patient expiring.

NRC Region I was called at 4:30 pm on November 3,1997 but it was after hours. Central Washington, D.C. number was also called but busy signal obtained. On the morning ofNovember 4,1997, contact was made with Ms.

Michelle Beardsley at the NRC Region I office and verbal report submitted.

Further calls were made in the afternoon of November 4th,6th and 7,1997 to provide furtherinformation.

Preca.utionary Steps to be Taken The pacemaker patient in this report was the last patient being monitored under special nuclear materials license SNM #1996 at AUHS/MCP Division. There are 4 patients, howe under our center city site license SNM #1369 currently being monitored. Based on expenen during this incident, the following will be instituted for remaining pacemaker patients:  !

1. Review of all policies and procedures specific for nuclear powered pacemakers (new policy enclosed as supplement C).

Implementation by: November 6,1997. ,

)

To be reviewed and approved by the AUHS Radiation Safety Committee at their next meeting in December 1997.

2. Radiation Safety Office staff was inserviced to reconfirm procedures related to pacemaker patients.  !

Implementation by: November 6,1997, at staffmeeting.

3. All currently monitored patients are to be contacted by the Radiation Safety Office to:

Assure that patients still have their special ID bracelets or some other form of pacemaker ID and that they are readable and that they are being worn or, otherwise, continuously on their person. {

e Verify name ofcurrent physician attending them.

Remind them of proper disposal pathway for pacemakers upon patient's expiration. Specifically, that the AUHS Radiation Safety Office must be called. (See Supplement D)

Implementation by December 15,1997.

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o o Page 4 Michelle Beardsley

4. Any ID badges reported damaged, lost or unreadable will be referred to the pacemaker company for replacements.

Implementation by: December 31,1997

5. Identified physicians caring for cunent pacemaker patients will be contacted and reinforced as to pacemaker procedures. (See Supplement E)

Implementation by: December 15,1997.

6. Will recommend to NRC that further written guidance concerning pacemakers be formulated and promulgated to special nuclear materials license holders. In addition, we believe that the cardiology and funeral home communities are, in general, in need of updating regarding disposal of these older pacemakers.

Implementation by: Upon receipt of this letter by the NRC.

Yours truly,

&s ,

Theodore Villafana, Ph.D.

Radiation Safety Officer

.. TV:lkf cc: William VanDecker, M.D.

Chris Nezu, Ph.D.

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Supplement A O O RADIAY10M PMSICS E SAF M DEPARTMENT I W ENTORY M STATUS E9BN E LICENSE NUMBER SNN-1996 (Ig[ \[g I Hast: l 7 n 3 cc- i: '

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b; Address:

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Model and serial 1:

Imolant Data:

c-101

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M DATA Address:

Telephone: .

current status: Circle one es circled, describe below)

Change YEs no Signature:. i

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Date: 4 N/ (,,~\

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' Supplemant A continued i

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Radiat tor Pr:ysics and Safety Office 33W . a. .,

now. ,,4 ru s.t.

215 842-6000 phone 215-842-6586 fax 215 643 5734 ALLEGHENY 1 U NI V E R SIT Y {

HOSPITALS gkk N

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EAST FALLS l f

May 28, 1997

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b I Rajnikant Shah, M.D.

Medical Arts Building - Suite 1 1723 Woodburn Road Levittown, PA 19057 i

Re: Special Nuclear Materials License Number SNM-1996

Dear Dr. Shah:

This is a semi-annual inquiry into the status of the Coratomic and Status F'orm. pacemaker patient listed on the attached Inventory The Nuclear Regulatory Commission under conditions of License Number SNM-1996 requires that(NRC),

the status of all implanted nuclear powered pacemakers be checked twice yearly and kept on file.

indicated. Please provide the necessary information where The inquiry has been structured so that a minimal amount of your time will be involved.

Thank you for your attention to this matter. i Sincerely, JJameswACairnes Administrative Coordinator Allegheny Health. Educateon and Research Foundation Ail. yine n, G .ne,4# Hosnani e Ahitiimy inttwm,4t H w"' f>".

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• A*vu>ny Vn'ver.itv ed the He4im Somors . AIRgy e

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r Supplement B j

W ALLEGHENY UNIVERSITY H O S PIT A L S EAST FALLS 3300 Henry Avense Phalacetohia PA 19129 215 842-6000 i

To: Jack Bonner, Suyuvisor l t

Dougherty Funeral Parlor 2200 Trenton Road Levittown, PA 19056

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From: Theodore Villafana, Ph.D M '

Radiation Safety Officer'~ ~ V Allegheny University of the Health Sciences 3300 Henry Avenue Philadelphia PA 19129 7  :

i Re: Pacemaker Status of 1 Date: November 7,1997

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As per our telephone conversation, we would like to verify that the following information concerning the pacemaker removed from is true.

Please verify it for accuracy, sign and return to me by return mail. Any corrections necessary can be written right in and initialed by you. Thank you.

= . .

Date of Expiration:

(

Date of Cremation: C Place of Cremation: American Cremation Corporation 1859 Stout Drive Warwick PA 18974

=

Date pacemaker was explanted: )

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Pacemaker was removed from body before cremation by:

Name: Jack Bonner j

Title:

Supervisor, Dougherty Funeral Parlor e

Pacemaker was buried as follows:

Place ofburial: Our Lady of Grace Cemetery Aghorne, PA Date of burial: f Plot or otherID#:

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The above is true and accu ate to the b st of my kno r edge.

Signed: e6' y - #Bf

Title:

/ M v # 2 X N 't - /

Datc:  !! ////26/92 /

/ f -"egyny eteartn, taucatnon anc tiessarcn rounaation Ahegneny General Hospitai e Allegneny integrated Health G50up

• Allegheny Urwvers.tv of the Heatth Sciences

• Allegheny U nstopher's HoSDetal for Chsidten '

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O o PATIENTS CONTAINING PACEMAKF.RS I

POLICY AND PROCEDURES  !

General  !

Up until around 1990, nuclear powered cardiac pacemakers were being implanted in patients. These pacemakers contained approximately 4.3 Curies of plutonium 238 (halflife = 87.75 years). Special NRC licensing had to be obtained for this material.

. Licensee was to be responsible for follow-up on status of the pacemaker to assure that it was recovered after patient expired and disposed ofproperly. Procedures are in place to monitor status of pacemaker and to assure proper recovery ofpacemaker.

Procedures

1. File to be kept including the following information:

Pacemaker manufacturer, model #, serial #, isotope and activity.

. . Dateofimplant.

Name and correct address ofpatient, isotope and activity.

Name and current address ofpatients' attending physician responsible for monitoring status ofpacemaker.

Final disposition ofpacemaker.

2. Every 6 months, the patient, the patient's family, and the patient's physician is to be contacted to determine status ofpatient and pacemaker.

3. Upon contact with individual, the following will be emphasized:

Importance of proper recovery of pacemaker in case patient expires.

• Imponance of wearing ID bracelets.

Inform Radiation Safety Office if bracelet needs replacement.

To submit name, address and telephone number of any new attending physician to be responsible for following up on status ofpacemaker.

4. - Contact will take the form of a standard form (see attached) with required information j

to be filled out by patient or attending physician.

i

5. Ifinitial attempt to contact patient is unsuccessful, all efforts will be made to assure a i

contact including contacting patient's last known physician, i

6. Upon failure to determine status ofpacemaker, the NRC regional office will be contacted and full details reponed to them.

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7. NRC to be informed when pacemaker is recovered and disposed ofproperly.

nu.n

s w a ... . u mu..uaueu PATIENTS CONTAINING PACEMAKERS POLICY AND PROCEDURES (cont.)

8. Proper disposal ofpacemaker consists of contacting vendor ofpacemaker and arranging for a shipping box and container and shipping pacemaker back to vendor.

9. Ifit is leamed that patient has expired and their remains are either buried or cremated without proper recovery ofpacemaker, the NRC is to be contacted immediately.

(Reporting time, ifloss or theft of material is known, is 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.) The following information is to be gathered and subsequently reported:

Patients' name and

- Date expired

- Date whether buried or cremated

- Place of burial or ashes ofdeceased Name and address offuneral parlor and funeral director.

Name ofindividuals who recovered pacemaker if any.

Present whereabouts ofpacemaker, if known.

r - dupp.Lement D

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INSTRUCTIONS TO ATTENDING PHYSICIANS Proper Disposal of Nuclear Powered Pacemakers Your patient has an implanted nuclear powered pacemaker which contains significant amounts of Plutonium - 238 (Pu238). This materialis controlled by the Nuclear Regulatory Commission (NRC). The use of this device comes under a specij NRC license issued by the NRC to the Allegheny University Hospitals. The status of the l pacemaker must be monitored by us to assure proper recovery and disposal of the pacemhker upon the death of the pacemaker recipient or explant of the device.

j The following procedures are to be followed.

Procedures 1 When your patient expires or when the pacemaker is explanted:

l Pacemaker, after explantation, is to be recovered for proper disposal.

(You should document date and person performing explant).

e Notify the Radiation Safety Office at Allegheny University of the Health l Sciences (AUHS/RSO): j 215-842-6588 or 215-762-4050 e

Special box will be provided to ship the pacemaker back to the original vendor. The AUHS/RSO will make arrangements for such return.

Pacemaker is not to be buried and under no circumstances to be cremate deceased.

i bupplemant t.

ALLEGHENY UNIVERSITY HOSPITALS RADIATION SAFETY OFFICE Verification of Pacemaker Location Ms. Jane Doe Current Address / Telephone No.

Address: 100 Main Street City: New Hope State: PA Zip Code: 19000 Phone No.: 555-555-5555 If the above address is incorrect, please make any changes in the space provided.

O The current address and phone number is correct.

I am carrying information concerning my pacemaker such as a card in my wallet or a bracelet or necklace.

O Yes O No If no, contact oar ofTice for a replacement (215-762-4050).

I The physician I am currently seeing in regard to my pacemaker is:  !

I Oct Name: John Hyde, MD Address: 200 Main Street City: New Hope State: PA Zip Code: 19000 '

Phone: 555-555-5050 If the above physician information is incorrect, please make any changes in the space provided.

O The current physician information is correct. '

Signature:

l Date-I Note: It is important foi us that if and when your pacemaker is removed that it be recovered and retumed for proper disposal.

If you require any additional information please call (215) 762-4050.

o O Radiation Physics and Safety Office g

3300 Henry A,en, Phdaderphia FA 19123 215-842-6000 phone 215-842-6588 fax 215 843 5734 A L L E G II E N Y

\ y UNIVERSITY ' kc 6 0 'J i II O S P I T A L S I [

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January 7, 1997 Rajnikant Shah, M.D.

Medical Arts Building - Suite 1 1723 Woodburn Road Levittown, PA 19057 Re: Special Nuclear Materials License Number SNM-1996

Dear Dr. Shah:

This is a semi-annual inquiry into the status of the Coratomic pacemaker patient listed on the attached Inventory and Status Form. The Nuclear Regulatory Commission (NRC),

under conditions of License Number SNM-1996 requires that the status of all implanted nuclear powered pacemakers be checked twice yearly and kept on file.

Please provide the necessary information where indicated. The inquiry has been structured so that a minimal amount of your time will be involved.

Thank you for your attention to this matter.

Sincerely, d

dames Cairnes

'h W Administrative Coordinator AHegheny Health, Education and Research Foundation Anegnen, Ge v', m:sr 'a e A eg"* , r :efrd't d Hee't" O's W

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l E8DIATION PHYSICS 8NJ SAPETY DEPARTMENT INVENTORY AND STATUS EORE NRC I,ICENSE NUMBER SNM-1996 Name: q

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Model 10.4 Serial J.: C-101 Implant D. git:

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Address:

Islephone:

Current Status: Circle One s circled, describe below)

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Change YES NO i

Signature: d Date: If((/9 7

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i 0FSClALRECORD00Pir ML 10 12 % ,

g. ; - s o o l-N4Ch This is to acknowledge the receipt of your letter / application dated M f , and to inform you that the initial processing which

j includes an administrative review has been performed.

i 4 .

7pM, s4h- /tri dThere were no administrative omissions. Your application was assigned to a

'j technical reviewer. Please note that the technical review may identify additional '

omissions or require additionalinformation.

C Please provide to this office within 30 days of your receipt of this card I

I

-} A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

Your action has been assigned Mail Control Number 1 9 R R Q .g When calling to inquire about this action, please refer to this controf riumber.

You may call us on (610) 337 5398, or 337-5260.

" '" 82m Sincerely, i Licensing Assistance Team Leader l

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