1314 Park Avenue Plainfield, NJ 07060 (908) 756- 1703

YOUNUS A. RAKLA, M.D., F.A.C.C. SALEEM HUSAIN, M. D.

INVASIVE, NON-INVASIVE AND INTERVENTIOHAL CARDIOLOGY

45 South Avenue W. Cranford, NJ 07016

(908) 276-1912

February 11, 1997

John D. Kinneman, Chief Nuclear Materials Safety Branch 2 Division of Nuclear Materials Safety Region 1 475 Allendale Road King of Prussia, Pennsylvania 19406-1415

RE: Docket No. 030-34337 Control No. 124129

Dear Mr. Kinneman,

This is in reference to your letter dated February 5, 1997. The additional information you requested is attached. We confirm and commit to Part 20 of 10 CFR.

9; Saleem Husain, M.D.

SH/ld

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This is in reference to the your letter dated February 5, 1997. Following is the additional information requested :

We confirm that our facility will adhere to new Part 20 regulation requirements and will update the procedure and policies as the regulation changes.

Thallium-201 and Cobalt-57 was on the list since same list was submitted to State of New Jersey license application. Please ignore the cyclotron produced items on the list.

The sealed source(s) requested in the application is for Dose Calibrator Quality Control as required under Appendix C, Reg. Guide 10.8, Rev. 2 and 35.50, The source requested ( 35.57( c ) ) is a 200 microcurie sealed Cs-137 source. No other sealed sources are requested at this time. We confirm that this source will be a part of our sealed source inventory and leak test will be performed as required under 1 OCFR 3 5.5 9.

Attached please find the license to practice medicine in the State of New Jersey.

Dr. Elmo R. Acio is an authorized user of byproduct material under NRC material license no. 37-00467-36

(a). The radiopharmaceuticals will be received as a unit doses and will be stored behind the lead bricks in the cave ( see the diagram “Hot Lab” ).

(b). Radioactive waste will be stored in the lead lined waste container placed underneath the counter top in the hot lab. Since the radionuclide used at our facility is short half life ( Tc-99m, 6 hours ) waste generated will be stored in the hot lab. The trash will be disposed off as required by 10CFR Part 20.2001(a)(2) and 35.92. The waste will be stored for minimum of 10 half life. The waste will be monitored and will be disposed off if the survey reading is equal to background reading. We Confirm that our radioactive waste storage and decay procedure will meet all the requirements indicated in Appendix R of Reg. Guide 10.8., Rev.2. The Hot Lab and scan room will be locked when unattended and during off hours and will be kept closed during working hours. Since the nuclear medicine area is at the end of the corridor no one can enter this area unless the secretary at front reception area permits or allow the individual to enter the facility, thus we feel that both radioactive material and waste is very well secured.

( c ). Please review the Hot Lab setup diagram. In one corner a cave is created with Lead bricks to store reference sources and daily doses. The radiopharmaceutical doses will be kept in lead container before the use in

its ammo container or behind the lead bricks. There is a lead glass L-Block for dose preparation and dispensing. The dose Calibrator is placed near the L-Block ( review the diagram ).

The radiation level in the unrestricted area is not a major problem at our facility since both Hot lab and scan room is located at the end of the building. This room shares its two walls with outside drive way and third wall with stairs thus no individuals will be exposed any where near the doses specified in 10 CFR 20.1301. Hot Lab share the wall with a bathroom and since the doses are shielded and stored in lead lined containers the exposure levels will be well within limits and doses to individual members of the public will never exceed the limits specified in 10 CFR 20.130 1.

[7]. As we indicated we will send our meter for annual calibration either at RMC or JRT Calibration Services (NRC License # 37-30298-01 ).

Since these labs are approved by NRC and there calibration procedures have been reviewed by NRC we will accept the calibration procedures of these calibration services in compliance and in concurrence with NRC regulation.

[SI. See Attached

[9]. RSO will follow the guide lines and criteria established in 10 CFR 20.1502 for monitoring individuals for exposure to radiation.

[lo]. Leak Test for the sealed radioactive sources will be performed by utilizing the delux wipe test counter. The trigger level for wipe test to be contamination free will be set so activity below 5.OE-4 uCi can be detected. ( see procedure attached )

[l 11. The weekly wipe tests are performed on Delux wipe test counter. Criteria for Pass and Fail are established in accordance with Table N-1 . Delux wipe test counter is set such that unit will Fail for all the samples that measures above 2000 dpm.

[12]. Our facility will not receive any shipment during off-duty hours. Since no shipment will be received during off-duty hours no special instruction is required. No unauthorized individual is allowed to enter the Nuclear Medicine Area during Off-duty hours.

[ 131. See explanation in item 12.

[14]. See attached updated Waste disposal procedure. Since waste generated will be short half life it will be stored in the lined container over weekend for decay and will be disposed off on Monday after the waste has decayed 10 half life.

See the cc r letter for explanati n.

We confirm that we will maintain all the records of worker training which will include the date, duration, topics covered, names of the attendees, name of the individual providing training etc.

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HOT LAB A: Dose Calibrator B: Sink C: Pb. lined double Sharps Box D:Pb. Bricks cave for sources

storage E: Pb. Lined waste container

underneath the countertop F: Pb. lined case for Co-57 disk

storage G: Lead h e d L-Block work area

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QUALITY CONTROL FOR DOSE CALIBRATOR

PURPOSE

The accuracy of the dose of the Radiopharmaceutical given to the patients depends on the performance of the Dose Calibrator. Therefore it is very important to have an acceptable QA program for the radionuclide dose calibrator. The QA program for the dose calibrator consists of tests to check the following:

1. Accuracy 2. Consistency/Precision 3. Linearity 4. Geometry dependence

PROCEDURE

1. ACCURACY

This test is normally performed by measuring the reference standards whose activity is traceable fo NBS (National Bureau of Standards). Since the radionuclides used in Nuclear Medicine have short half lives, it is not possible to get a standard for such a radionuclide. Therefore a radionuclide standard with a long half life and similar photon energy to the nuclide used in Nuclear Medicine should be used with appropriate correction factors.

Different radionuclide standards such as Co-57, and Cs-137 are normally used in Nuclear Medicine.

a. Take several measurements of the standards at appropriate instrument settings.

b. Compare the average of these measurements with the decay corrected standard

decay corrected standard activity. I activity, The measured activity of the standard should be within + or - 5% of the

This test is normally performed at the Installation of tlik dose calibrator and quarterly thereafier (See form No A, Dose Calibrator Accuracy Test ).

2. PRECISION/CONSTANCY CHECKS:

This test will be performed daily on the dose calibrator. The instrument should be accurate and reproducible within an acceptable degree of precision in measuring the constant activity over time.

,

3.

The standards are chosen such that their photon energies are close to the radionuclides routinely assayed. Thus Cs- 137 (1 00-200-uCi) and Co-57 (3-5 mCi) will simulate Mo-99 and Tc-99m respectively.

a. Measure the background level at the appropriate instrument setting for the radionuclide standard that is being measured. (Co-57 setting for CO-57). If the instrument is equipped with the automatic background subtraction, make sure it is functioning properly. (see operating manual).

b. Measure the activity of each standard and log the net readings on the appropriate forms. (Form B )

c. For Co-57 standard, make sure that the measured activity falls within + or - 5% of the decay corrected, expected activity. (Column: Cal Act, Form B ).

d. Repeat the procedure for the Cs- 137 standard and log the measurements on Form B.

e. Repeat the measurements using Cs- 137 standard at the instrument settings for the various radionuclides used in the department and log the readings on Form B.

f. This test for consistency MUST be performed daily prior to the use of the dose calibrator for patient doses and the measured activity of the standard should fall within + or -5% of the calculated activity. If the measurements DO NOT fall within the set limits then:

1.

ii. Notify: DO NOT USE THE DOSE CALIBRATOR.

(1) RSO

* LINEARITY.

The Dose Calibrator should be linear over a wide ranger of activities. This means that he Dose Calibrator should be accurate in measuring a few microcuries to Curies. There are several methods that may be used to determine the linearity of the dose calibrator. ( see attached example C & D)

a. A Unit Dose of the maximum activity normak used should be used for the Radiopharmacy to perform this test.

b. A Tc-99m vial with the maximum activity is measured at various time intervals until it decays down to 30 uCi, or one can measure the activity using the commercially available kit with various attenuators. (CAL CHECK) Refer to the manual provided with the kit.

c. Plot the measured activity versus time n the semilog graph paper and draw a best fit straight line through the points.

d. The activities plotted should be within + or - 5%, of the calculated activity, if the instrument is linear and functioning properly.

e. If the errors found are greater that + or - 5%:

1.

11. Notify: DO NOT USE THE DOSE CALIBRATOR

(1) RSO (2) Medical Physicist

..

4. GEOMETRICAL DEENDANCE

Check for Geometrical Dependence is normally done when the instrument is first installed, after major repair, and whenever a change is made in the type of vial or the syringe used in the Radiopharmaceutical dose preparations. New generation dose calibrators are normally geometrically independent. However, it should be checked initially and the manufacturer's data should also be checked.

a. Take a 20 to 30 ml vial with 1-2 mCi in 1 to 2 ml.

b. Assay the vial.

c. Increase the volume in the vial with water in steps of 2,4,8,10,15,20,25,ml. Assay the vial after each addition of water. Net activity is obtained by subtracting the background.

d. Select one of the volume as the Standara and calculate the Correction Factor (CF) for each of the volumes.

Standard volume activity CF = Volume Activity

e. Plot the CF versus Volume on the linear graph paper. Use this graph to select the proper Volume Correction for routine assay of that radionuclide.

f. The true activity of the sample is given by:

True Activity = Measured Activity X CF

g. Similarly the CF for the syringes can be obtained. Note: CF for plastic syringes cannot be used for glass syringes. Geometrical Variation should be no more than + or - 2%

See the Example E attached.

..

Dose Calibrator Accuracy I I

I I Date April 7,1994 Activity (mCi): 191.60

Dose Calibrator: A a a ~ Cal S o ~ r c ~ T y p ~ : CS-137 SN: SS6004-39 Modd No.: 2002

Test Perfonned by: RFP Calibration: 221 uCi, Feb 1,1988

MEASUREMENTS

190.1 189.9 18 189.9

190.0 190.0 190.0 190.0 190.1

l8W 190.0 190.1 3;

190.1 190.0 190.1 189.9 190.2 189.5 190.2 190.1 190.1

AVERAGE ACTIVITY OF CS im.012

[ - S./.Activity]: 182.02 [ + 5 Yo Activity]: 201.18

If the Average A T c r t + 1 - S Yo rmge:

DO NOT: DOSE CALIBRATOR

NOTIFY: 14. C~T- PI. Medical Physicist / RSO ..

Medical Physicist / S O - ,

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Cedarbrook Cardiology

3.79 . 4.19 -+- __ - - -I--- '

I _ 3.78 * 4-!8 , __ -

I 3.77 4.17 _. __-r--p- --y;:::li , 3.74 4.13 j j

I I ! 3.73 , 4.12 ' I 7 I , 3.72 . 4.11 I I I 3.71 j 4.10

1 3.70 , 4.09 I

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3.69 1 4.08 j 3.68 . 4.07

3.67 4.06 ' -

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1 3.66 4.04 -

~ 3.65 4.03

Order a New Source:

170.78 188.76

170.77 188.75

170.76 188.74

170.75 188.73

170.74 188.71

170.73 188.70

1170.72 188.69

~ 170.70 ~ 188.67

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DostCalibratorLindty [

Date: June 6,1994

Dac Cdibrrtor: Aearcal ModclNa: 2002

TutPcrformedby: RFP

20 cc vial

Hopn MudActMty Cd ActMty

462.65 511.35 29.863 1.46 28.37 31.36

1.81 2.00 1.905 4.24 2.84 0.11 0.12 0.116 5.70 0.01 0.01

0.00 487 mCi 24.17 30.3 mCi 48.00 1.9 mCi 72.25 0.119 mCi 96.42 0.0073. mCi

A

& ~ K E ~ O C 5.70

Do Not Use the Dose Calibrator w i t h +/- 5% range NOTIFY: MedicalP

& MINIMUM % Error is NOT

/RSO arid Chief Techaologist

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Activity vs T h e 1 I

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Cedarbrook Cardiology tJQ,+yL- EXAMPLE

1 Dose Calibrator Linearity I Date: Method: Cal Check

Dose Calibrator: Source Type: Vial Model No.: Source (mCi): 1027.5

i Test Performed by: RFP -- --__I -- /i

Displayed Calibration Product I

Black 1027.50 * 1 .oo 1027.50 I I Black & Red 327.00 * 3.14 I Black & Orange 83.75 * 12.27

' Black & Yellow 41.80 * 24.58 1 Black & Green 9.68000 * 106.15

Black & Blue 4.98500 * 206.12 Black & Purple 1.56300 * 657.39

I Purple & Red 0.46550 * 2207.30

027.50 i

027.50 ,' 027.50 027.50 027.50 027.50 027.50

I Purple & Orange 0.12975 * 79 19.08 1027.50 Purple & Yellow 0.07045 * 14584.8 1 1027.50 I

Purple & Green 0.01860 * 55241.94 1027.50 985 13.90 1027.50

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I Purple & Blue 0.0 1043 *

, Mean: 1027.50 Upper Limit: 1078.88 Maximum: 1027.50 Lower Limit: 976.13 Minimum: 1027.50

Minimum and Maximum Must be within Lower and Upper Limits.

, **** IF THE DATA ARE NOTI WITHIN LIMITS **** ***** DO NOT USE THE DOSE CALIBRATOR *****

***** NOTIFY YOUR SUPERVISOR ***** ***** NOTIFY YOUR MEDICAL PHYSICIST / RSO *****

Performed By: , .

Cedarbrook Cardiology

EXAMPLE

1 Geometrical Dependence & Variation

Date: November 9, 1995

Dose Calibrator: Capintec Source Type: 3.35 mCi vial

Loaner Unit Model No.: CRC 5

Test Performed by: RFP

Volume Activity YO Error Correction ml mCi Factor

2 3.350 0.00 3 3.360 0.30 5 3.360 0.30 7 3.380 0.90 10 3.370 0.60 13 3.340 -0.30

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0.99

0.97

I Correction Factor vs Volume]

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ml ( c c )

Cedarbrook Cardiology

Sealed Source Leak Test

Method: Smear test will be performed by taking a moist swab. All external surfaces of the source will be wiped with the moist swab. The swab will then be placed in the sample holder of the Delux wipe test counter. The counting interval of 5 minutes will be selected. The Pass threshold will be set at 200 dpm. The appropriate QC will be performed with (3-137 source provided by the manufacturer. The swab will than be counted for 5 minutes. Results will be displayed as PASS or FAIL. The sensitivity of the instrument at 200 dmp is lower than threshold level ( 5.OE-4 uCi ) required for leak test of the seald radioactive source.

Result: Thus PASS will be considered that the removable contamination is less than 5.OE-4 uCi. Thus the source will be considered leak free. The instrument sensitivity setting of 200 dpm is equal to 9.OE-5 uCi. Thus the sensitivity is well below the threshold requirement set for sample to be considered contaminated or leaking.

Test Performed By: Radiation Safety Officer

. t

RADIOACTIVE WASTE MANAGEMENT

PURPOSE

The Nuclear Medicine Department uses radionuclides for both Diagnostic and Therapeutic procedures. These radionuclides have different half lives (T U2). The dose preparations and injections produce waste which is contaminated by the radionuclides and therefore is classified as Radioactive Waste. It is the responsibility of the Nuclear Medicine Department Staff to handle and dispose of this radioactive waste APPROPRIATELY.

Radioactive Waste if not handled properly becomes a RADIATION HAZARD and can cause unnecessary exposure to the members of the general public and can contaminate the Environment. Therefore proper waste management is a very important function of the Nuclear Medicine Department.

Under no circumstances should Radioactive Waste be disposed of through the regular waste WITHOUT PROPER MONITORING.

PROCEDURE

In the Nuclear Medicine Department approximately 75% of the time short half life Radionuclides (99m Tc). Therefore it is very easy to separate the waste by it's half life and store it for decay before disposal.

Short Half Life: Any radionuclide with Half Life of seven (7) hours or less.

Long Half Life: Any radionuclide with Half Life of seven (7) hours or more.

Collection of Short Half Life and Long Half Life Radioactive Waste:

Sine the Nuclear Medicine Department operates from Monday to Friday, it is easy to collect the waste from Monday to Friday. Leave the trash in the lead lined waste container for decay during week end in the Hot Lab.

Collect ALL Short and Long half life waste and label and separate them appropriately as follows:

(a.) All 99m Tc waste (b.) All 201 TI waste

and (e.) All other waste SEPARATELY in the containers provided for these wastes.

DO NOT MIX SHORT AND LONG HALF LIFE MATERIALS.

1. Syringesrneedles:

Place all the syringes and needles in the lead container that was received from the local pharmacy. Place all the lead syringe container in the boxes provided by the local pharmacy. Ship this boxes to the pharmacy after wipe tested and when the boxes are found to be contamination free. I

Log the wipe test results in the appropriate forms.

All other contaminated trash must be placed in the appropriate lead lined container for storage.

Store this container in the hot lab for decay (10 half lives) before disposal. (follow disposal procedure)

Follow the same procedure for Thallium 201 and other long half life materials. These wastes must be collected separately in the containers provided. NO MIXING OF THESE WASTES IS ACCEPTABLE.

Store this trash for decay (10 half lives) before disposal. Follow the disposal procedure.

When the trash is placed in the Hot Lab for Storage and for decay, record the following information on the form provided:

1 . Storage Date: the day the trash is placed in the Hot Lab in the lead lined trash container.

2. Half Life: e.g. 6 hrs for 99m Tc waste.

3. Isotope.

4. Proposed Disposal Date: e.g. for 99m Tc waste disposal is after 60 hrs (10 half lives ). So if the waste was stored on the first of the month, then the proposed disposal date would be the third of the month.

5 . Date Waste was Disposed: Actual date when the waste is removed fiom the Hot storage area for disposal after 10 half lives.

6. Survey. a. BKG: background reading taken outside of the hot lab room in the

hallway.

b. Waste: reading of the trash bag surveyed.

7. Remarks: Any unusual findings such as high readings after 10 half lives or if the trash was placed for further decay.

DISPOSAL PROCEDURE:

Short Half Life waste stored for decay will be disposed as follows:

1. Whenever handling radioactive trash always use gloves , lab coat, film badge, and ring badge.

2. Every Monday remove the 99m Tc waste from the previous week from the Lead lined waste container.

3. Check the battery on the survey instrument. Take a background radiation reading outside the Hot Lab area in the hallway.

4. Make sure that the survey instrument is operating at the lowest scale (0.05-0.1 W).

5 . Record the background radiation level on the disposal form. (see attached)

6 . Place the trash on absorbent pads and place in the front room or hallway and survey the trash thoroughly from all sides,

7. If the survey readings are NOT ABOVE THE BACKGROUND RADIATION LEVEL READINGS THEN DISPOSE OF THE TRASH IN THE REGULAR TRASH. Follow the facility guidelines for the regular trash.

8. IF THE SURVEY READINGS ARE ABOVE THE BACKGROUND RADIATION LEVEL: DO NOT DISPOSE THE TRASH. STORE THE TRASH FOR ANOTHER 24 HOURS.

9. Survey the trash after 24 hours. If the reading is NOT ABOVE THE BACKGROUND RADIATION LEVEL THEN DISPOSE OF THE TRASH AS REGULAR TRASH. Follow the facility guidelines for the trash. If the survey readings are still above BACKGROUND RADIATION LEVEL: DO NOT DISPOSE OF THE TRASH. NOTIFY THE RADIATION SAFETY OFFICER.

10. After the completion of the disposal procedure the Technologist must monitor hisher : a. Hands b. Clothes C. Bottoms of the shoes. d. Record the readings in the appropriate forms.

Long Half Life waste stored for decay will be disposed of as follows:

1. Whenever handling radioactive trash always use gloves, lab coats film badge and ring badge.

2. Long half life material will be removed after it has been stored for 10 HALF LIVES. Follow the disposal procedure.

3. Take the background radiation reading outside the Hot Lab in the hallway.

4. Make sure that he survey instrument is operating at the lowest scale (0.05- 0.1 mR/hr)

5 . Record the background radiation level on the disposal form. (see attached)

6 . Place the trash on the absorbent pads and place in the front room or hallway and survey the trash thoroughly from all sides.

7. If the readings of the survey are NOT ABOVE THE BACKGROUND RADIATION LEVEL READINGS THEN DISPOSE OF THE TRASH IN THE REGULAR TRASH. Follow the facility guidelines for the regular trash.

8. IF THE SURVEY READINGS ARE ABOVE THE BACKGROUND RADIATION LEVEL: DO NOT DISPOSE OF THE TRASH. STORE THE TRASH FOR ANOTHER WEEK.

9. Survey the trash again after one more week. If the reading is NOT ABOVE THE BACKGROUND RADIATION LEVEL THEN THE DISPOSE OF THE TRASH AS REGULAR TRASH. Follow the facility guidelines for the trash. If the survey readings are still above BACKGROUND RADIATION LEVELS: DO NOT DISPOSE OF THE TRASH. NOTIFY THE RADIATION SAFETY OFFICER.

10. After completion of the disposal procedure the Technologist must monitor hisher:

a. Hands b. Clothes C. Bottoms of shoes d.

1

Record the readings on the appropriate forms.

’

This is in reference to the your letter dated February 5 , 1997. Following is the additional information requested :

[l]. We confirm that our facility will adhere to new Part 20 regulation requirements and will update the procedure and policies as the regulation changes.

[2]. Thallium-201 and Cobalt-57 was on the list since same list was submitted to State of New Jersey license application. Please ignore the cyclotron produced items on the list.

[3]. The sealed source(s) requested in the application is for Dose Calibrator Quality Control as required under Appendix C, Reg. Guide 10.8, Rev. 2 and 35.50, The source requested ( 35.57( c ) ) is a 200 microcurie sealed Cs-137 source. No other sealed sources are requested at this time. We confirm that this source will be a part of our sealed source inventory and leak test will be performed as required under lOCFR 35.59.

[4]. Attached please find the license to practice medicine in the State of New Jersey.

[5]. Dr. Elmo R. Acio is an authorized user of byproduct material under NRC material license no. 37-00467-36

[6]. (a). The radiopharmaceuticals will be received as a unit doses and will be stored behind the lead bricks in the cave ( see the diagram “Hot Lab” ).

(b). Radioactive waste will be stored in the lead lined waste container placed underneath the counter top in the hot lab. Since the radionuclide used at our facility is short half life ( Tc-99m, 6 hours ) waste generated will be stored in the hot lab. The trash will be disposed off as required by lOCFR Part 20.2001(a)(2) and 35.92. The waste will be stored for minimum of 10 half life. The waste will be monitored and will be disposed off if the survey reading is equal to background reading. We Confirm that our radioactive waste storage and decay procedure will meet all the requirements indicated in Appendix R of Reg. Guide 10.8., Rev.2. The Hot Lab and scan room will be locked when unattended and during off hours and will be kept closed during working hours. Since the nuclear medicine area is at the end of the corridor no one can enter this area unless the secretary at front reception area permits or allow the individual to enter the facility, thus we feel that both radioactive material and waste is very well secured.

( c ). Please review the Hot Lab setup diagram. In one corner a cave is created with Lead bricks to store reference sources and daily doses. The radiopharmaceutical doses will be kept in lead container before the use in

1 CEDARBROOK CARDIOLOGY I I WASTE DISPOSALLOG c

Isotope:

Si nature -1

Do Not Dispose Any Waste If Waste Survey Reading Exceeds Back Ground Reading