Text

Revised Radiological Safety Procedures
	ML20196E580
Person / Time
Site:	07003078
Issue date:	06/10/1999
From:	Laura Smith; ATLANTIC RICHFIELD CO. (ARCO)
To:	;
Shared Package
ML20196E557	List: ML20196E550; ML20196E567; ML20196E574; ML20196E580;
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	1624, NUDOCS 9906280313
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1 RADIOLOGICAL SAFETY PROCEDURES Prepared for ARCO 444 South Flower Street Los Angeles, CA 90071

-('LhtL Laurence STnith CIH, CSP Project Manager Work Order No. 01624-061-002 l

Prepared by ROY F. WESTON,INC.

1400 Weston Way West Chester, PA 19380 10 June 1999 9906280313 990618 PDR ADOCK 07 8

i TABLE OF CONTENTS Receipt of Newly Explanted Arco Nuclear Radioisotope Procedure 1624-01 Powered Pacemakers Storage Room Monitoring and Surveying Procedure 1624-02 Inventorying and Recordkeeping Requirements for ARCO Procedure 1624-03 Nuclear Radioisotopes Powered Pacemakers Emergency Actions and Decontamination Procedure 1624-04 EMERGENCY CONTACT LIST 1

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l l

ARCO Procedure: 1624-01 Rev.2 Effective Date: 1 June 1999 TITLE:

RECEIPT OF NEWLY EXPLANTED ARCO NUCLEAR RADIO 1SOTOPE POWERED PACEMAKERS 1.0 PURPOSE This procedure describes the steps to be followed for receipt of ARCO nuclear radioisotope powered pacemakers.

2.0 APPLICABILITY This procedure is applicable to WESTON employees involved in pacemaker receipt.

3.0 REFERENCES

3.1 USNRC Regulatory Guide 7.3, " Procedures for Picking Up and Receiving Packages of Radioactive Material."

3.2 10 CFR 20, " Standards For Protection Against Radiation."

3.3 WESTON Procedure 1624-02, " Storage Room Monitoring and Surveying."

3.4 WESTON Procedure 1624-03, " Inventorying and Recordkeeping Requirements for ARCO Nuclear Radioisotope Powered Pacemakers."

4.0 PREREQUISITES Calibrated Dose Rate Meter Smears and Smear Record Folders Overpack Can Small Plastic Bags Record Book i

Key to storage room Anti-C Gloves 5.0 PRECAUTIONS Anti-C gloves are to be wom when handling pacemakers.

6.0 PROCEDURES 6.1 Pacemakers are delivered by US Postal Service or other carrier to WESTON. When the pacemakers are received in the mailroom at WESTON, they will be picked up and moved to the storage area within 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months .

If the Post Office or other carrier holds the pacemaker for pickup, then within 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months (% hours if a weekend or holiday) WESTON personnel will proceed to the Post Office or other carrier's ofYice for pacemaker pickup.

6.1.1 If the pacemaker package is undamaged, it is signed for and transported to the storage room at WESTON.

6.1.2 If the pacemaker package is damaged, it is placed in an overpack contsner, the appropriate paperwork filled out, delivery accepted, transported to the storage room at.WESTON, and WESTON's Project Manager / Radiation Safety Officer notified.

6.2 Upon arrival at the WESTON storage area, proceed as follows:

6.2.1 Go to the storage area and monitor the door with the dose rate meter. If the dose rate is less than 2,000 microroentgens per hour (or 2 milliroentgens per hour (2 mR/hr)), open the door and continue.

6.2.1.1 If the dose rate is greater than 2,000 microroentgens per hour (2 mR/hr), do not open the door to the storage area and call the WESTON Project Manager / Radiation Safety Officer.

6.2.2 The dose rate at the surface of the unopened package is then made, it should be less than 5,000 microroentgens per hour (5 mR/hr).

6.2.2.1 If the dose rate at the surface of the unopened package is greater than 5,000 microroentgens per hour (5 mR/hr),

contact the WESTON Project Manager / Radiation Safety Officer.

6.2.2.2 If the dose rate is less than 5,000 microroentgens per hour (5 mR/hr), wipe test the surface of the unopened package. The wipe test should cover an area of 100 square centimeters.

6.2.3 Put on Anti-C gloves.and carefully open the package, exposing the pacemaker and proceed as in 6.2.2.1 and 6.2.2.2 for the pacemaker.

6.2.4 Record the serial number of the pacemaker, log it into the inventory, and then place it into the lead lined storage container.

6.2.5 - Check the inventory against the pacemakers in storage; if there is a discrepancy, contact the WESTON Project Manager / Radiation Safety Officer.

6.2.6 Prepare and ship the wipes for alpha and beta analyses.

7.0 RECORDKEEPING REQUIREMENTS 7.1 The following information will be recorded as appropriate.

7.1.1 All information requested on the Pickup and Delivery of ARCO Nuclear Radioisotope Powered Pacemaker Form shall be completed for each pacemaker received.

7.1.2 The pacemaker serial number shall be entered onto the written inventory (Refer to Procedure 1624-03).

7.1.3 DOE /NRC Form 741 shall be completed as required (Refer to Procedure

~

1624-03).

7.1.4 Provide written confirmation to ARCO of the removal date, reason for removal, patients name, and pacemaker serial number.

7.1.5 When results of the wipe tests are received, enter them on the Pickup and Delivery of ARCO Nuclear Radioisotope Powered Pacemaker Form.

ARCO Procedure: 1624-01 Rev 3 W O. =01624-061-001-0002 Effecuve Date: 30 May 1998 1

PICK-UP AND DELIVERY OF ARCO NUCLEAR RADIOISOTOPE i

j POWERED PACEMAKER

{

!O Pacemakerts) delivered to WESTON Employee accepting delivery Date and time ofdeliverv

{

l i

Carrier

{

10 WESTON Pick-Up ofPacemakens)

Employee makmg pick-up Date and time of pick-up 3.0 Condition ofPackage 4

Intact

)

}

Dair.egM 3.1 Ifdamaged, desenbe 3.2 Ifdamaged, was a report filed? Yes No I

i 3.2.1 Ifno damage report was filed, explam 4.0 Dose Rate Measurements and %rpe Test Results i

4.1 Dose rate back,vond mR/hr 4.2 Dose rate at storage area door mR/hr 4.3 Dose rate at surface ofunopened package mR/hr 4.4 Dose rate at surface ofpacemaker mR/hr Paae i of 2

)

(

l

)

45 Wipe test results Unopened package alpha dpm/100cm (<22) 2 2

beta dpm/100cm (<220)

Pacemaker alpha dpm/100cm (<22) beta dpm/100cm (<220) 5.0 Pacemaker Serial Number 6.0 Inventory Check 6.1 Number ofpacemakersinirventory 6.2 Number ofpacemakers in storage 7.0 Survey Instrument 7.1 Type 7.2 Model 7.3 Serial #

7.4 Calibranon Date 8.0 Commeas_

Prepared By Date 1

Approved By Date NOTE:If the dose rate or wipe test measurements exceed the parer 6 ud values the WESTON Project Manager /Radianon Safety Officer shall be contacted w=

Pane 2 of 2 4

ARCO Procedure: 1624-02 Rev.2 Effective Date: 13 September 1995 TITLE:

STORAGE ROOM MONITORING AND SURVEYING 1.0 PURPOSE This procedure describes the steps to be followed in the quarterly monitoring of the WESTON storage area for ARCO nuclear radioisotope powered pacemakers. The storage area is located behind Building 2 at One Weston Way, West Chester, PA 19380.

2.0 APPLICABILITY This procedure is applicable to the pacemaker storage area at Roy F. Weston, Inc. only.

3.0 REFERENCES

3.1 USNRC Regulatory Guide 8.23, " Radiation Safety Serveys at Medical Institutions."

3.2 10 CFR 20, " Standards For Protection Against Radiation."

3.3 WESTON Procedure 1624-03, " Inventorying and Recordkeeping Requirements for ARCO Nuclear Radioisotope Powered Pacemakers."

4.0 PREREQUISITES Calibrated Dose Rate Meter Wipe Test Samplers Overpack Can Record Book Key to storage room Anti-C Gloves 5.0 PRECAUTIONS Anti-C gloves are to be wom when taking wipe tests.

6.0 PROCEDURES 6.1 On a quarterly calendar basis, the storage area is monitored and surveyed as follows:

6.1.1 Go to the storage area and monitor at the door with a dose rate meter, it the dose rate is less than 2,000 microroentgens per hour (or 2 mR/hr), open the door and continue.

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- 6.1.1.1 If the dose rate is greater than 2,000 microroentgens per hour (2 mR/hr), do not open the door. Contact the WESTON Project Manager / Radiation Safety Officer for additional guidance. The technician may continue when the source of the elevated radiation level has been identified and evaluated.

6.1.2 Remove the Troxler Guages from the storage area if present. Monitor each of the four lead storage boxes approximately 1 inch above the top of the box with the dose rate meter and record the readings on the survey form.

6.1.3 Take a wipe test sample from the interior of each lead lined storage box.

6.1.4 Check the inventory of pacemakers against the pacemakers in storage. If

.there is a discrepancy in the inventory, contact the WESTON Project Manager / Radiation Safety Officer.

6.1.6 Prepare and ship the smears to the laboratory for alpha and beta analyses.

7.0 RECORDKEEPING REQUIREMENTS 7.1 The following information will be recorded on the Quanerly Storage Room Monitoring and Surveying Results Form.

7.1.1 Date, time, and name of person conducting the monitoring and wrveying.

7.1.2 Results of all dose rate measurements and wipe test results.

7.1.3 Results of the inventory check.

7.1.4 Description of the survey instrument including serial number and last calibration date.

7.1.5 Sign and date the Form.

7.1.6 The Project Director or Project Manager shall review and approve the Form

. by signing the Form.

ARCO Procedure: 1624-03 Rev.2 Effective Date: 1 June 1999 TITLE:

INVENTORYING AND RECORDKEEPING REQUIREMENTS FOR ARCO NUCLEAR RADIOISOTOPE POWERED PACEMAKERS 1.0 PURPOSE This procedure describes the inventorying and recordkeeping requirements for the receipt and storage of ARCO Nuclear Radioisotope Powered Pacemakers.

2.0 APPLICABILITY This procedure is applicable to the inventorying and recordkeeping requirements for Arco pacemakers.

3.0 REFERENCES

3.1 10 CFR 20, " Standards For Protection Against Radiation."

3.2 WESTON Procedure 1624-01, " Pickup and Delivery of ARCO Nuclear Radioisotope Powered Pacemakers."

3.3 WESTON Procedure 1624-02, " Storage Room Monitoring and Surveying."

4.0 PREREQUISITES Forms found in the Appendix of this procedure.

5.0 PRECAUTIONS Not applicable.

6.0 PROCEDURES 6.1 WESTON shall maintain files for all procedural items identified in Procedures 1624-01 and 1624-02.

6.2 The file shall be subdivided into five seperate files.

6.2.1 Receipt ofPacemakers.

6.2.1 Storage Room Monitoring and Surveying Results.

6.2.3 PacemakerInventory 6.2.4 Smear sample chain-of-custody (or coverletter to the laboratory) and results.

6.2.5 DOE /NRC Form 741s.

6.3 '

The forms shown as attachments to this procedure shall be used (there is no form for 6.2.4).

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ARCO Procedure: 1624-04 Rev.3 Effective Date: 1 December 1993 Revised: 1 June 1999 TITLE:

EMERGENCY ACTIONS AND DECONTAMINATION 1.0 PURPOSE This procedure defines emergencies and the actions taken to ameliorate an emergency situation.

2.0 APPLICABILITY This procedure is applicable to the pacemaker storage area at Roy F. Weston, Inc. only.

3.0 REFERENCES

3.1 USNRC Regulatory Guide 8.21, " Health Physics Surveys for By-Product Material at NRC Licensed Processing and Manufacturing Plants."

3.2 USNRC Regulatory Guide 8.23, " Radiation Safety Surveys at Medical Institutions."

3.3 10 CFR 20, " Standards For Protection Against Radiation."

3.4 WESTON Procedure 1624-01, " Pickup and Delivery of ARCO Nuclear Radioisotope Powered Pacemakers."

3.5 WESTON Procedure 1624-02, " Storage Room Monitoring and Surveying."

4.0 PREREQUISITES Prerequisites are dependent upon the situation.

5.0 PRECAUTIONS Prerequisites are dependent upon ti.e situation.

6.0 DEFINITIONS 6.1 Authority - The authority to declare an emergency vests with the WESTON Project Manager / Radiation Safety Officer.

6.2 Emergency - An emergency is defined as the real or potential release of radioactive

materials from the pacemakers, or the loss of a pacemaker.

6.3 Emergency Levels - There are four emergency levels as shown below:

)

6.3.1 Level 1 Local Emergency - Contamination is confmed within the lead lined storage containers.

6.3.2 - Level 2 Area Emergency - Contamination is confmed within the storage area.

6.3.3 Level 3 Environmental Emergency - Contamination is outside the storage

. area.

6.3.4 Level 4 Administrative Emergency - A pacemaker is missing from the inventory and presumed to be lost or stolen.

6.4 Contamination - Contamintion is defined as :

6.4.1 Removable alpha contamination greater than 22 dpm/100 cm.

2 6.4.2 Removable beta contamination greater than 220 dpm/100 cm,

2 6.4.3 Fixed alpha contamination greater than 110 dpm/100 cm.

2 6.4.4 Fixed beta contamination greater than 1100 dpm/100 cm,

2 7.0

' PROCEDURE The following procedures are followed for the four emergency levels.

7.1 Level 1 Local Emergency A local emergency can result from receipt of a damaged pacemaker; finding contamination levels in excess of the allowable limits during pacemaker pickup and delivery or during the storage room monitoring or surveying; or minor fires, floods, explosions, or other unusual events. The procedural steps are:

7.1.1 WESTON's Project Manager / Radiation Safety Officer is notified i

immediately of receipt of a damaged pacemaker, or excess dose rates or contamination levels.

7.1.2 WESTON's Project Manager / Radiation Safety Officer evaluates the situation and if an emergency exists, takes immediate actions to control the situation then informs ARCO.

7.1.3 A plan is then prepared and implemented to ascenain and evaluate:

i J

The extent ofcontamination.

The levels ofcontamination.

The reasons for the contamination.

l 7.1.4 Based upon the results of 7.1.3, the following are developed and implemented as required:

Restrict access to areas of contamination.

Decontamination of contaminated areas or personnel.

Verification ofdecontamination.

- Lifting of access restrictions.

Procedural changes to avoid future emergenc'es.

i 7.1.5 Reports, as required, are pcepared for submission to the U.S. Nuclear Regulatory Commission (USNRC) as per 10 CFR 20. The WESTON Corporate Radiation Safety Officer shall be informed 'of any emergencies.

7.2 Level 2 Area Emergency An area emergency can result from the same conditions as stated in 7.1 with the contamination spreading from the lead lined storage boxes to the storage area. The procedural steps described in 7.1 should be followed for a Level 2 Area Emergency.

7.3 Level 3 Environmental Emergency An environmental emergency can occur under the same conditions as described in a Level 1 Local Emergency, but usually is the result of a major fire, explosion, flood, earthquake or other unusual event. An environmental emergency is declared whenever contamination spreads beyond the storage area. The procedural steps are:

7.3.1 An environmental emergency is assumed in the event of a major disaster.

7.3.2 Any fireman, police, rescue workers, etc. shall be informed of the potential radiation hazard.

7.3.3 The USNRC shall be telephoned immediately at (610) 337-5000 and advised of the situation.

7.3.4 The WESTON Project Manager / Radiation Safety Officer shall be contacted i

immediately. The WESTON staff member will take appropriate actions to control or contain the emergency, then notify ARCO.

7.3.5 Reports, as required, are prepared for submission to the U.S. Nuclear i

- Regulatory Commission (USNRC) as per 10 CFR 20. The WESTON Corporate Radiation Safety Officer shall be informed of any emergencies.

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7.4 Level 4 Administrative Emergency An administrative emergency is declared when a pacemaker is unaccounted for, lost or stolen. The procedural steps are:

7.4.1 WESTON's Project Manager / Radiation Safety Officer is notified of an

unaccounted for, lost or stolen pacemaker.

7.4.2 WESTON's Project Manager / Radiation Safety Officer evaluates the situation and if an emergency exists, takes appropriate actions to locate the pacemaker. ARCO shall be contacted as soon as por.sible.

7.4.3 A search for the pacemaker and questioning of personnel shall be conducted, and if after a reasonable period of time the pacemaker is not found, then the USNRC is telephone at (610) 337-5000.

7.4.4 Reports, as required, are prepared for submission to the U.S. Nuclear Regulatory Commission (USNRC) as per 10 CFR 20. The WESTON Corporate Radiation Safety Officer shall be informed of any emergencies.

8.0 RECORDKEEPING REQUIREMENTS

- A bound, paginated Emergency Log Book shall be maintained for recording all communications and actions taken during and emergency. The minimal information, as appropriate, to be recorded

'i shall be:

8.1 Level of emergency declared, the person declaring the emergency, the date and time of this declaration.

8.2 A record of all telephone calls made and received, to include:

Person making telephone call.

Person receiving telephone call.

Date and tirpe ofcall.

8.3

. A record of all personnel, police, firemen, etc. receiving notification of the radiation hazard, to include:

Person making notification.

=

' Persi)n rectiving notification.

=

. Date and time ofnotification.

8.4 All radiation survey results, to include:

' Date and time ofmeasurement.

Location ofmeasurement.

Results ofmeasurement.

8.5

' Restricted area identification, to include:

Date and time ofrestriction.

Method whereby area was restricted.

Date and time restriction was lifted.

1 8.6 Any other appropriate information, such as:

)

. Decontamination plan.

Monitoring program plan.

J

]

ARCO RADIOISOTOPE POWERED PACEMAKER PROGRAM EMERGENCY CONTACT LIST WESTON

Contact:

Laurence C. Smith, CIH, CSP Project Manager Roy F. Weston, Inc.

1400 Weston Way P.O. Box 2653 West Chester, PA 19380 Work: (610) 701-3028 Hone:(610) 687-0107 Robert Massengill, RRPT Radiation Safety Officer Roy F. Weston, Inc.

1400 Weston Way P.O. Box 2653 West Chester, PA 19380 Work:(610) 701-5243 Home:(610) 689-8949 ARCO Contact / Arco Safety

Contact:

Mike McAnulty ARCO l

444 South Flower Street Los Angeles, CA 90071 Work:(213) 486-3641

)

USNRC

Contact:

U.S. Nuclear Regulatory Commission King of Prussia, PA (610)337-5000 Police

Contact:

911 Fire Department

Contact:

911

PACEMAKER RETRIEVAL FORM Name of person receiving telephone call:

Date and time of telephone call:

Name of person and company placing telephone call:

Address:

Telephone Number:

)

1 Name of pacemaker owner:

Pacemaker Serial Number:

Date pacemaker explanted:

Reason for removal:

s Ship container to:

Name:

Same as person placing call Address:

Telephone Number:

Date container will be shipped:

Date of expected delivery:

Courier:

Tracking Number:

Fed Ex US Mail [.,] UPS

' Other Shipping ackage including dangerous good stickers forwarded with container?

Yes No Date pacemaker will be shipped:

Date of expected delivery at WESTON:

Courier:

Tracking Number:

Fed Ex 0 US Mail O UPS Other Contact Arco:

Date and time of call:

Spoke with:

Yes No O Left message Notes:

i l

Project Manager Signature Date:

j

QUARTERLY STORAGE ROOM MONITORING AND SURVEYING RESULTS J

Person (s) performing smvey Date and time of Survey Dose Rate Measurements and Wine Test Results I

Dose rate background mR/hr Dose rate at storage area door mR/hr Average dose rate measurements above storage boxes mR/hr i

Were any measurements above the storage boxes greater than 5 mR/hr?

Yes No If yes, stop work and contact the project manager and project RSO. List the results Location Result Box 1, top mR/hr Box 2, top mR/hr Box 3, top mR/hr Box 4, top ~

mR/hr Wine Test Results WW 'ALPHAC%1/',

RP-

-BETAM t e

Location Dpm/100 cm' pCi Dpm/100 cm' pCi Box 1 Inside Box 2 Inside Box 3 Inside Box 4 Inside Random Pacemaker 6

5 Action Limit

<22

<9.9x10

<220

<9.9x10 Inventory Check -

Number of pacemakers in inventory Number of pacemakers in storage

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Survev Instrument Type Model Serial #

Calibration Date Comments Prepared by Date Approved by Date NOTE: If the dose rate or wipe test measurements exceed the listed action limits, the WESTON Project Manager / Radiation Safety Officer shall be contacted.

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ML20196E580

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