"Radiopharm Quality Mgt Program."

' %* y . b h N /fb"$f " " N a f

? < Radiopharmaceutical Quality Management Program St. Elizabeth Medical Center, Dayton Ohio -

If a procedure involves greater than 30 microcuries of Iodine-131,

. Iodine-125, Phosphorus-32 or Strontium-89,.the technologist must obtain a. written directive from an authorised user, (physician). The written directive shall include the following information:

~'a) Patlent's Name b) Isotope Name c) Quantity, specified in millicuries or microcuries d) Date e) Signature

In addition to the above, the technologist'must verify by more than one method, the identity of _ the patient as the individual named on the written directive. Therefore, the following protocol shall be followed:

a) The technologist shall ask the patient their name, and confirm that

; the name is _on the written directive.

b) The technologist shall obtain additional verification _of the patient's identity by obtaining at least one of the following:

1. Name on a Document 2. Birth date 3. Address 4. Social Security Number 5. Signature

The information obtained will.then be compared to one of the following:

1. Drivers License 2. Social Security Card 3. ID Bracelet 4. Medical Insurance Card For patients seen in the Radiation Therapy Department 7 a polarold picture of the patient is routinely taken on the first visit. For these individuals, who will return at a later date for their therapy, visual identification of the patient via the polarold picture will suffice as a form of identification.

Prior to administration of the isotope, the radiopharmaceutical dose and route of administration must be confirmed by the technologist. The dose will be checked in the dose calibrator and that reading will be compared to the number in the written directive. Should the dif ference between the numbers exceed +/- 5 percent for written directives issued for greater than 10 aCl or +/- 10 percent for written directives that are 10

QH Program-1 May 1994

9506160497 940003 PDR ADOCK 03002700 C PDR _ , , . . .- ._ . .. - - = - - -. . - - . .. __. , ; :- g , > w w

mCl or less, the technologist shall notify the physician who wrote the original. written directive and explain the situation. It is the "~ . physician's option to either amend or issue a new written directive or cancel the study altogether.

Whether the patient is an inpatient or outpatient, after administration of the isotope, the authorised user or technologist shall document the following on the quality management form: '

a. Administered dose i b. Date | c. Signature ; All the information stated above shall be documented-and become a permanent record of the patient's Nuclear Medicine / Radiation Therapy chart, and be kept for review by NRC inspectors. |

If there is any doubt in the technologist 's mind as how to carry out a -

Written directive, then they should contact the medical physicist (ext. i 6687) or the Nuclear Medicine Department Manager, for clarification and ' or instructions. Under no circumstances should the technolocist continue with the procedure unless it is clear in their mind as to the proper | procedure to follow.

The radiopharmaceutical quality management program will be reviewed during the radiation safety committee quarterly meetings. The review

will include all Iodine-131, Iodine-125, Phosphorous-32 and Strontium-89 , cases that were performed during the previous quarter. An annual summary | of the QH program shall also be documented.

~ .

QM Program-2 May 1994 |

,- __ _ -_ _ . - . _ _ . ._ . , ,, '

, p L a' g - -

Brachytherapy Quality Management Program St. Elizabeth Hedical Center, Dayton Ohio

Introduction: Individuals involved in brachytherapy procedures consist of the radiation oncologist, physicist and radioth'erapy technologists. The oncologist initiates a brachytherapy procedure by issuing a written directive. The written directive is then carried out, in part, by the physicist. The physicist will instruct the technologists on their role regarding the written directive. If the technologist has any questions as what or what not to do, then they shall seek counsel with the physician or physicist before carrying out any part of their duties.

Before the Implant:

1) Initially, the treatment planning computer's algorithm, used for calculating the patient 's dose, shall be tested for accuracy and acceptance tested by the medical physicist prior to patient use.

2) All brachytherapy procedures require a written directive from the radiation oncologist. The written directive shall include the following informations

(a) Patient's Name (b) Treatment Site (c) Isotope Name (d) Nominal Tumor Volume Dose (e) Date (f) Signature

3) Prior to administration of the implant, the isotope, source strength, loading sequence, and number of sources shall be checked for agreement with that of the written directive. If the sources to be used are Cesium-137, source strength shall be checked by color code. 4) Prior to implantation, Radiation Therapy personnel must verify by more than one method, the identity of the patient as the individual named on the written directive. Therefore, the following protocol shall be followed:

(a) The radiation oncologist, having met with the patient before, shall visually confirm the identity of the patient.

(b) Radiotherapy personnel shall obtain additional verification of the patient's identity by obtaining at least one of the following:

QH Program-3 May 1994

| . - - . - - -..- - -- -.

:* ' ' . . ;( _

w w ; ' i

(1) Birth date -(11) Address. (iii) Social security number ; 4 (iv) Signature.. (v) Name on the patient's ID bracelet

The-information obtained will then be compared to information from I ' the patient's Radiation' Therapy- chart.

5) Verification films'shall be taken, unless source holders are of a fixed geometry. During the filming process " dummy" sources shall be used whenever.possible. '

.. . ! Durina the Implant: '

- ! 1) After implantation, but before the conclusion of the treatment, the radiation oncologist shall document the' following in the patient's ' chart, or other applicable forms

(a) Radioisotope (b) Treatment site { (c) For temporary implants: The loading sequence of the sources inserted

For permanent implants: The total number of seeds implanted . (d) Total source strength (e) Date and Time (f) Signature

2) Prior to the completion of the therapy, the radiation-oncologist shall ' also documents

(a) Exposure time or total dose I (b) Signature (c) Date

3) The physicist will recheck and document that the dose calculations are correct before the total prescribed brachytherapy dose has been administered. Computer generated dose calculations shall'be checked by examining the printout to verify that the correct data for the patient were used in the calculations, ie., isotope, number of sources, total source strength, and loading sequence.

After the Implants

i 1) If the implant is temporary, the patient and room shall be surveyed ! before the patient is allowed to leave the room and before the room may ' be occupied by another patient. Patients who receive permanent implants shall be surveyed at one meter with their exposure rates documented.

QM Program-4 : May 1994 |

, _ - _ . , _ _. _ . _ _ _ * ,-- , e V -

2) A summary of patient dosimetry will be performed and signed by the radiation oncologist and physicist. 3) All the above information (except information regarding acceptance testing of the treatment planning computer algorithm) shall be documented and become a permanent record of the patient's Radiation Therapy chart, and kept for review by NRC inspectors. -

OH Program Review:

The brachytherapy quality management program will be reviewed during the radiation safety committee quarterly meetings. The review will include all brachytherapy cases that were performed during the previous quarter. An annual summary of the QH program will also be documented.

QH Program-S May 1994

_ -. _ __- - __-_-__ _ - b . -

. 34-cal]&-oI Radiopharmaceutical Quality Management Program St. Elizabeth Medical Center, Dayton Ohio

If a procedure involves greater than 30 microcuries of Iodine-131, Iodine-125, Phosphorus-32 or Strontium-89, the technologist must obtain a written directive from an authorized user, (physician). The written directive shall include the following informations

a) Patient's Name b) Isotope Name c) Quantity, specified in millicuries or microcuries d) Date e) Signature

In addition to the above, the technologist must verify by more than one method, the identity of the patient as the individual named on the written directive. Therefore, the following protocol shall be followed:

a) The technologist shall ask the patient their name, and confirm that the name is on the written directive.

b) The technologist shall obtain additional verification of the patient's identity by obtaining at least one of the following:

1. Name on a Document 2. Birth date 3. Address 4. Social Security Number 5. Signature

The information obtained will then be compared to one of the following:

1. Drivers License 2. Social Security Card 3. ID Bracelet 4. Medical Insurance Card

For patients seen in the Radiation Therapy Department, a polarold picture of the patient is routinely taken on the first visit. For these individuals, who will return at a later date for their therapy, visual identification of the patient via the polarold picture will suffice as a form of identification.

Prior to administration of the isotope, the radiopharmaceutical dose and route of administration must be confirmed by the technologist. The dose will be checked in the dose calibrator and that reading will be compared to the number in the written directive. Should the difference between the numbers exceed +/- 5 percent for written directives issued for greater than 10 mC1 or +/- 10 percent for written directives that are 10

QH Program-1 May 1994 m a39702J

09%% %p _ m 3

. b b i w w l i .. 1 aCl or less, the technologist shall notify the physician who wrote the , original written directive and explain the situation. It is the ' physician's option to either amend or issue a new written directive or L cancel the study altogether.

Whether the patient is an inpatient or outpatient, after administration of the isotope, the authorized user or technologist shall document the following on the quality management forms

a. Administered dose b. Date c. Signature

All the information stated above shall be documented and become a permanent record of the patient's Nuclear Medicine / Radiation Therapy chart, and be kept for review by NRC inspectors.

If there is any doubt in the technologist's mind as how to carry out a written directive, then they should contact the medical physicist (ext. 6687) or the Nuclear Medicine Department Manager, for clarification and or instructions. Under no circumstances should the technologist continue with the procedure unless it is clear in their mind as to the proper- ; procedure to follow.

The radiopharmaceutical quality management program will be reviewed during the radiation safety committee quarterly meetings. The review will include all Iodine-131, Iodine-125, Phosphorous-32 and Strontium-89 cases that were performed during the previous quarter. An annual summary of the QM program shall also be documented.

! QM Program-2

May 1994 i

! - - .- - - . . -- _- ...... -.. - b b w w , ,

Brachytherapy Quality Management Program | St. Elizabeth Medical Center, Dayton Ohio ;

| Introduction | Individuals involved in brachytherapy procedures consist of the ! radiation oncologist, physicist and radiotherapy technologists.'The oncologist initiates a brachytherapy procedure by issuing a written

directive. The written directive is then carried out, in part, by the *

physicist. The physicist will instruct the technologists on their role [ regarding the written directive. If the technologist has any questions i as what or what not to do, then they shall seek counsel with the . | physician or physicist before carrying out any part of their duties. ;

! Before the Implants f

1) Initially, the treatment planning computer's algorithm, used for ! calculating the patient's dose, shall be tested for accuracy and acceptance tested by the medical physicist prior to patient use. )

' 2) All brachytherapy procedures require a written directive from the radiation oncologist. The written directive shall include the following informations

(a) Patient's Name ; (b) Treatment Site (c) Isotope Name - (d) Nominal Tumor Volume Dose (e) Date ? (f) Signature

3) Prior to administration of the implant, the isotope, source strength, loading sequence, and number of sources shall be checked for agreement i with that of the written directive. If the sources to be used are .j Cesium-137, source strength shall be checked by color code.

. 4) Prior to implantation, Radiation Therapy personnel must verify by more than one method, the identity of the patient as the individual named on the written directive. Therefore, the following protocol shall be .followed:

(a) The radiation oncologist, having met with the patient before, shall

visually confirm the identity of the patient. J

(b) Radiotherapy personnel shall obtain additional verification of the patient's identity by obtaining at least one of the following | ) i

. |

QM Program-3 May 1994

,- . - - ._- . -- . . . - . - ______--_ _ ___. 6 . 1

* b w w

, .c

(1) Birth date (11)~ Address (111):Soctal security _ number (iv) . Signature -(v) Name on the patient's ID bracelet The information obtained will then be compared to information from the patient's Radiation Therapy chart.

5)' Verification films shall be taken, unless source holders are of a fixed geometry. During _ the filming process "dunny" sources shall be.used whenever possible.

- Durina the-Implant: , 1) Af ter implantation,|but before the conclusion of the treatment, the radiation oncologist shall document the -following in the patient 's chart, or other applicable forms

(a) Radioisotope (b) Treatment site (c) For temporary implants: The loading sequence of the sources inserted For permanent implants: The total number of seeds implanted (d) Total source strength (e) Date and Time (f) Signature

2) Prior to the completion of the therapy, the radiation oncologist shall also document s

(a) Exposure time or total dose (b) Signature (c) Date

3) The physicist will recheck and document that the dose calculations are correct before the total prescribed brachytherapy dose has been - administered. Computer generated dose calculations shall be checked by examining the printout to verify that the correct data for the patient were used in the calculations, le., isotope, number of sources, total -source strength, and loading sequence.

After the Implant:

1) If the implant is temporary, the patient and room shall be surveyed before the patient is allowed to leave the room and before the room may be occupied by another patient. Patients who receive permanent implants shall be surveyed at one meter with their exposure rates documented.

QM Program-4 May 1994

a -

* b w w

2) A summary of patient dosimetry will be performed and signed by the radiation oncologist and physicist.

3) All the above information (except information regarding acceptance testing of the treatment planning computer algorithm) shall be documented and become a permanent record of the patient's Radiation Therapy chart, and kept for review by NRC inspectors.

OM Program Review:

QH Program-5 May 1994

{x,omstr pn -, - .. . z,sygg,

; , ,- ' O C -

Radiopharmaceutical Quality Management Program St. Elizabeth Hedical Center, Dayton Ohio

a) Patient's Name

b) Isotope Name , c) Quantity, specified in millicuries or microcuries I d) Date e) Signature

In addition to the above, the technologist must verify by more than one | method, the identity of the patient as the individual named on the ' written directive. Therefore, the following protocol shall be followed:

a) The technologist shall ask the patient their name, and confirm that the name is on the written directive.

b) The technologist shall obtain additional verification of the patient's identity by obtaining at least one of the following:

1. Name on a Document 2. Birth date 3. Address 4. Social Security Number 5. Signature

The information obtained will then be compared to one of the following:

1. Drivers License 2. Social Security Card 3. ID Bracelet 4. Medical Insurance Card

For patients seen in the Radiation Therapy Department, a polarold | picture of t..e patient is routinely taken on the first visit. For these individuals, who will return at a later date for their therapy, l visual identification of the patient via the polaroid picture will i suffice as a form of identification. '

Prior to administration of the isotope, the radiopharmaceutical dose and ; route of administration must be confirmed by the technologist. The dose will be checked in the dose calibrator and that reading will be compared to the number in the written directive. Should the difference between

the numbers exceed +/- 5 percent for written directives issued for | greater than 10 aCl or +/- 10 percent for written directives that are 10

QH Program-1 May 1994

_fl1 }{5Ttp?fC[Cf7* ,. - .. .. .- . - - - ......

* ., g g - s - i i s. ! | . mC1 or less, the technologist shall notify the physician who wrote the | l original. Written directive and explain the situation. It is the u

. physician's option to either amend or issue a new written directive or | cancel the study altogether. I

Whether the patient.is an inpatient or outpatient, after administration , of- the isotope, the authorized user or technologist shall document the , following on the quality management form: ;

i a. Administered dose ! b. Date c. Signature All the information stated above shall be documented and become a permanent record of the patient's Nuclear Medicine / Radiation Therapy chart , and. be kept for review by NRC inspectors.

If there is any doubt in the technologist's mind as how to carry out a written directive, then they should contact the medical physicist (ext. .) 6687) or the Nuclear Medicine Department Manager, for clarification and ) or instructions. Under no circumstances should the technolocist continue with the procedure unless it is clear in their mind as to the proper , procedure to follow.

The radiopharmaceutical quality management program will be reviewed ! during the radiation safety committee quarterly meetings. The review will include all Iodine-131, Iodine-125, Phosphorous-32 and Strontium-89 cases that were performed during the previous quarter. An annual summary of the QM program shall also be documented. <

J QM Program-2 j Hay 1994 i grari 397021 .

- -.-. -. ... _ _ - - .. .. - . . . . - ...... _ _ _ _ _ . __ - _ __-__- .__ - _ __ - __ - ______- . f ~ a $ O w -

. Brachytherapy Quality Management Program St. Elizabeth Hedical Center, Dayton Ohio

Introduction:

Individuals involved in brachytherapy procedures consist of the radiation oncologist, physicist and radiotherapy technologists. The | oncologist initiates a brachytherapy procedure by issuing a written [ directive. The written directive is then carried out, in part, by the i physicist. The physicist will instruct the technologists on their role regarding the written directive. If the technologist has any questions as what or what not to do, then they shall seek counsel with the physician or physicist before carrying out any part of their duties.

Before the Implant:

1) Initially, the treatment planning computer's algorithm, used for calculating the patient's dose, shall be tested for accuracy and acceptance tested by the medical physicist prior to patient use.

2) All brachytherapy procedures require a written directive from the radiation oncologlet. The written directive shall include the following j informations i

i (a) Patient's Name (b) Treatment Site (c) Isotope Name (d) Nominal Tumor Volume Dose (e) Date (f) Signature

4) Prior to implantation, Radiation Tnerapy personnel must verify by more than one method, the identity of the patient as the individual named on the written directive. Therefore, the following protocol shall be followed

(a) The radiction oncologist, having met with the patient before, shall visually confirm the identity of the patient.

(b) Radiotherapy personnel shall obtain additional verification of the patient's identity by obtaining at least one of the following:

F f ; QM Program-3 L Hay 1994

- ______--. . - _ - _ - _ - - - . , . . . a e - -

(1) Birth date (11) Address i (iii) Social security number { (iv) Signature j [ (v) Name on the patient's ID bracelet j

'l The information obtained will then be compared to information from the patient's Radiation Therapy chart.

5) Verification films shall be taken, unless source holders are of a fixed I geometry. During the filming process " dummy" sources shall be used l whenever possible.

During the Implant:

1) After implantation, but before the conclusion of the treatment, the ' radiation oncologist shall document the following in the patient 's chart, or other applicable forms

2) Prior to the completion of the therapy, the radiation oncologist shall also documents

(a) Exposure time or total dose (b) Signature (c) Date i 3) The physicist will recheck and document that the dose calculations are { correct before the total prescribed brachytherapy dose has been administered. Computer generated dose calculations shall be checked by

examining the printout to verify that the correct data for the patient ; were used in the calculations, ie., isotope, number of sources, total ' source strength, and loading sequence.

i After the Implant:

| 1) If the implant is temporary, the patient and room shall be surveyed { before the patient is allowed to leave the room and before the room may be occupied by another patient. Patients who receive permanent implants shall be surveyed at one meter with their exposure rates documented.

QH Program-4 May 1994 i ' gmcr 39702% l

- - _ - - - _ ------J ._

< ! . * .= .g & i w -

' . !

2) A summary of patient dosimetry will be performed and signed by the , radiation oncologist and physicist. -

3) All the above information (except information regarding acceptance testing of the treatment planning computer algorithm) shall be documented and become a permanent record of the patient 's Radiation Therapy chart, and kept for review by NRC inspectors. |

OH Procram Review:

, The brachytherapy quality hanagement program will be reviewed during the radiation safety committee quarterly meetings. The review will include all brachytherapy cases that wcre performed during the previous quarter. An annual summary.of the QM program will also be documented.

;

| | QH Program-5 May 1994

O f..!}9.. I.II. %.. . o .Oc~f

w. - -