Brachytherapy and Radiopharmaceutical Quality...

Barnes-Jewish Hospital/Siteman Cancer Center Washington University School of Medicine

Mallinckrodt Institute of Radiology Radiation Oncology Department

Medical Physics Division

Brachytherapy and Radiopharmaceutical Quality Assurance Manual

Revision: Aug 15 07 I. INTRODUCTION

II. ROLES AND RESPONSIBILITIES OF CLINICAL BRACHYTHERAPY PERSONNEL

A. Physician

B. Physicist

C. Radiation Safety Department

III. GENERAL QA AND SAFETY REQUIREMENTS

A. Brachytherapy-Radiopharmaceutical Therapy Quality Management Program (QMP)

1. General QMP Procedures

2. Procedures Specific QMP Guidelines-QMP DOCUMENT

B. Other General Policies QMP Policies

IV. HIGH DOSE-RATE BRACHYTHERAPY QUALITY ASSURANCE

A. General Aspects of HDR Brachytherapy Quality Assurance

1. Positional Accuracy

2. Accuracy of Source Strength:

3. Temporal Accuracy:

4. Radiation Safety:

B. Commissioning, Acceptance Testing and Annual Review

C. Quarterly QA Protocol

D. Daily QA

E. Computer Treatment planning Systems

F. Treatment Specific QA

1. Procedure Checklist

2. Prescription Form

3. Physics Review (HDR Treatment Review Checklist)

4. Additional Operational Guidelines

V. RADIOPHARMACEUTICAL THERAPY QUALITY ASSURANCE

A. Ordering of Radiopharmaceuticals

1. General Procedures

2. Additional Considerations

B. Radiopharmaceutical Receipt and Handling

1. General Radiation Safety Considerations

-2-

2. Contamination Control and Radiation Surveys

C. Determination of Activity of Radiopharmaceuticals

1. Linearity and constancy of dose calibrator

2. Accuracy of dose calibrator

3. Activities of Record for Gamma and Beta Emitters

4. Criteria for Administration of Activity of Record

D. Administration of Radiopharmaceuticals

1. Patient Release Criteria

2. Administration Procedures

E. Nursing QA in Caring for Radiopharmaceutical Patients

F. Radiopharmaceuticals Quality Assurance Check-Off List

VI. PERMANENT IMPLANT PROSTATE BRACHYTHERAPY QA

A. General Aspects of Permanent Prostate Brachytherapy Quality Assurance


2. Source Strength Accuracy

3. Temporal Accuracy

4. Radiation Safety

5. Dose Calculation Accuracy

B. Commissioning, Acceptance Testing

1. Sources

2. Computer-Assisted Treatment Planning Systems

C. Annual Review(s)

1. Calibration Instrumentation

2. Treatment Planning System

3. Ultrasound Machine

4. Fluoroscopic C-arm

D. Treatment-specific QA and Procedures

1. Pre-Treatment Preparation

2. Implant

3. Post-Implant Plan

VII. PERMANENT IMPLANT LUNG BRACHYTHERAPY QA

A. General Aspects of Permanent Prostate Brachytherapy Quality Assurance




4. Radiation Safety



-3-

1. Sources


C. Annual Review(s)





2. Implant

3. Post-Implant Plan

VIII. TEMPORARY EYE PLAQUE BRACHYTHERAPY QA

A. General Aspects of Permanent Eye Brachytherapy Quality Assurance




4. Radiation Safety



1. Sources


C. Annual Review(s)





2. Implant

IX. LOW DOSE RATE BRACHYTHERAPY QUALITY ASSURANCE

A. General Aspects of LDR Brachytherapy Quality Assurance


2. Accuracy of Source Strength


4. Radiation Safety



1. Intracavitary Sources

2. Applicators

3. Dummy Sources

4. Source Strength Calibration Device

-4-

5. LDR Treatment Rooms

6. Commissioning of Remote Afterloading Devices


C. Annual Review(s)

1. Manual Brachytherapy

2. Remote Afterloading Devices

D. Quarterly Checks

E. Treatment-Specific QA


2. Applicator Insertion Procedure

3. Radiographic Evaluation of Implant

4. Prescription

5. Manual Afterloading: Source Preparation, Source Loading and Room Posting

6. Remote Afterloading: Source Preparation, Programming and Room Posting

7. QA Responsibilities During Treatment

8. Isodose and Treatment Time Calculation

9. Source and Applicator Removal

F. Source Return and Disposal

X. CONTINUING EDUCATION

-5-

I. INTRODUCTION

This document defines the mandatory quality assurance program required by all brachytherapy services affiliated with the Department of Radiation Oncology at Barnes-Jewish Hospital/Washington University School of Medicine. Quality assurance endpoints, criteria, specific tests, documentation requirements and associated administrative procedures are defined in detail. Recommendations are expressed in terms of should and shall. Shall indicate that the recommendation is an essential ROC quality assurance guideline, which must be followed. Failure to carry out and document such a procedure may result in a 'physics QA violation' entry in the ROC quarterly QA report. Use of 'should' in a recommendation implies it is to be followed when practicable. In practice, it is expected that any significant deviation from "should" require a justification.

Each of these QA functions is described in detail in the following sections. Detailed protocols, or where deemed useful, self-documenting forms, have been generated. For patient-specific QA, these forms are intended to be part of the patient's permanent therapy record. In some cases, (e.g., QA check-off list), submission to the Radiation Oncology Center QA office is required. Many of the periodic QA forms are designed for submission to the QA office, although the originals are to be kept on file at each of the respective institutions. Each affiliated brachytherapy service shall utilize documentation devices having equivalent or greater information content than the forms appended to this document. In the interests of uniformity of physics practice, all services should use the recommended documents.

II. ROLES AND RESPONSIBILITIES OF CLINICAL BRACHYTHERAPY PERSONNEL

Successful delivery of accurate and safe brachytherapy treatments require cooperation among several different classes of professional and technical staff including referring physician, radiation oncologist, physicist, therapists, dosimetrists and nurses. Unlike external beam, applicator placement, simulation, treatment planning and treatment delivery all occur within a compressed time frame. In the extreme case of high dose-rate brachytherapy, the entire process is executed in a few hours and large fractions (500-1500 cGy) delivered in a few minutes. Each participant must clearly understand his/her role, its limits and the source of supervision in order to interact efficiently in delivering treatment.

The following guidelines should be followed within the context of performing brachytherapy procedures.

A. Physician: Overall responsibility for medical management of the patient including:

1. Consultation with physicist to define treatment goals in terms of physical endpoints, to facilitate

any desired preplanning, optimization, special device fabrication, as well as planning of treatment. 2. Insertion of applicators. 3. Review of implant imaging studies, definition of target volume, completion of written prescription

and selection of active source treatment positions and/or loadings. 4. Direct supervision of radioactive source insertion and removal; routine and emergency applicator

removal; and supervision of Radiation Oncology Center nursing staff during procedures. 5. Review of final treatment plans, treatment documentation, and treatment-time calculations. For

HDR treatments, all such calculations required to select dwell times and weights shall be reviewed before initiating treatment. LDR treatment plans and calculations which may influence the treatment prescription (e.g., interstitial implant isodose plots) should be reviewed as soon as possible after they are available. In accordance with applicable NRC regulations any modification of the treatment prescription shall be documented in writing and signed by an authorized user within 24 hours of the modification for routine modifications and 48 hours for emergency modifications.

-6-

6. An authorized user (physician) shall be physically present (within normal voice range) during the start of all HDR treatments. Subsequently a physician trained in the emergency removal of applicators shall be physically present during all HDR treatments.

B. Physicist: Overall responsibility for converting physician's clinical intent and prescription into an

actual treatment. 1. The physicist should supervise all technologists and dosimetrists involved in simulating,

planning, calculating and delivering treatment. This includes: a. Supervision of simulation including: patient positioning, adequacy of radiographic views,

labeling, and acquisition of non-radiographic measurements b. Preparation of simulation radiographs for treatment planning based on target volume and

prescription c. Prioritization of dosimetrists' brachytherapy workload to ensure that treatment plans needed to

finalize or modify the treatment prescription are completed as early as possible the afternoon of, or the morning following the procedure

d. Validation of graphic treatment plan including all input data, consistency with prescription

and documentation standards, and integrity of treatment calculations e. Applicator-source preparation and remote afterloader function during treatment Physicists can and should delegate these tasks but must use good judgment as to when

intervention and review are necessary. This will depend on the skill and knowledge of the support staff, familiarity with the procedure, and degree to which the procedure depends on dose calculation. Prescribed checks, for each implant type, are listed in this protocol.

2. The physicist has primary responsibility for correct utilization and operation of all sources,

applicators, treatment delivery equipment, dose calculation, source reconstruction and display algorithms.

In collaboration with the involved radiation oncologists, the physicist is responsible for

developing and maintaining a quality assurance program to ensure accurate operation of the above equipment.

3. In collaboration and cooperation with the radiation safety officer, the physicist is responsible for

radiation safety and license compliance. Physicists should never put themselves in the position of withholding treatment from a patient, against the physician's wishes, because of a perceived or actual violation of QA rules or regulatory constraints. Such a course of action is warranted only if the safety or welfare of the patient, staff or public is immediately and clearly threatened. In other circumstances, the physicist's role is limited to advising physicians on regulatory/QA policies, developing procedures to make compliance easy, and reporting physician or staff actions that jeopardize the institution's regulatory standing to the QA committee, Radiation Safety Officer, NRC and/or Division Head as appropriate.

4. An authorized HDR medical physicist shall be present for all HDR treatments.

C. Radiation Safety Department

1. Annual calibration of survey meters and detectors shall be the responsibility of Radiation Safety Department.

-7-

2. Annual accuracy test and quarterly linearity test of dose calibrator shall be the responsibility of Radiation Safety Department.

3. Weekly wipe tests and quarterly surveys of brachytherapy areas shall be performed by Radiation

Safety Department. 4. Radiation safety personnel shall perform QMP audits.

5. Radiation safety annual training shall be provided by Radiation Safety Department.

6. Radiation Safety Department shall be responsible for receipt and return of radioactive materials

and sources. III. GENERAL QA AND SAFETY REQUIREMENTS

A. Brachytherapy and Radiopharmaceutical Therapy Quality Management Program (QMP)

1. General QMP Procedures

All brachytherapy and radiopharmaceutical therapy procedures shall conform to the following requirements (these are presented in greater detail in our QMP document).

A. Prior to the administration of treatment, a written prescription (directive) should be prepared and

signed by a physician authorized by the Washington University Radiation Safety Committee to perform the brachytherapy or therapeutic radiopharmaceutical procedure prescribed.

B. In the event that a patient’s condition precludes the preparation of a written directive, an oral

directive may be obtained. Oral directives shall be signed and dated by the authorized user within 24 hours of their issuance. Oral revisions of a written directive are treated as oral directives, and require authorized user’s signature within 24 hours of their issuance.

C. Before any therapeutic radioisotope procedure is begun, the patient shall be identified by more

than one active method (e.g., by name and date of birth). D. Before the end of treatment, a physicist (or designee) shall confirm that the "plans of treatment"

(isodose treatment plans, calculations, source strength, etc. as specified by the WUMS QMP for each procedure type) are in accord with the written prescription.

E. Prior to delivering any radioisotope treatment, the individual (physician, physicist, and technologist) responsible for treatment administration shall review the written prescription and determine that the administration is consistent with that document.

F. All radioisotope treatments shall be appropriately documented in the patient's Radiation Oncology

Chart.

F. Representative samples of patient records shall be audited at least annually, to look for previously undetected recordable events and medical events.

2. Procedure Specific QMP Guidelines- QMP DOCUMENT

Section I outlines definitions, reporting, auditing and general requirements of the QMP program while Section II describes the QMP implementation for each therapeutic modality.

Recommendations are expressed in terms of should and shall. Use of “Shall” indicates that the recommendation is an essential ROC quality assurance guideline, which must be followed. Use of 'should' in a

-8-

recommendation implies it is to be followed when practicable. In practice, it is expected that any significant deviation from "should" require a justification.

I. Administrative Structure and Monitoring Requirements This document describes revised quality assurance guidelines and clinical procedures for sealed-source and Radiopharmaceutical therapy intended to supplement the procedures outlined in the Radiation Oncology Center Brachytherapy Quality Assurance and Clinical Procedures Manuals. Their purpose is to assure compliance with NRC regulations regarding quality management and reporting requirements (10 CFR parts 2 and 35) The Brachytherapy-Radiopharmaceutical and Gamma Knife QMP's stand as independent documents which can be revised independently of one another. The current document applies only to radioisotope procedures performed by Washington University radiation oncologists or supported by Washington University/ROC radiation oncology physicists. This includes all sealed source procedures and therapeutic radiopharmaceutical procedures for malignant disease. Unsealed isotope administrations for diagnosis or for treatment of benign disease are the responsibility of the Division of Nuclear Medicine and are not covered by this document. We reserve the right to delete, to add, or to modify any of our QA policies, associated forms and documentation without NRC approval and without notifying NRC or the radiation safety committee as long as we satisfy the requirements imposed by our QMP program description, 10 CFR 20 and 35 and our license. A. Definition of Medical Event Any event that results in;

1) Delivered Dose/Activity that differs from Prescribed dose/activity by > 20% and if it falls outside a Prescribed Dose/Activity Range.

2) Delivered fractional Dose/Activity that differs by more than 50% from fractionally prescribed dose/activity.

3) A Dose of > 5 rem whole body EDE or >50 rem tissue/organ that results from a. Administration of a wrong Radioactive drug b. Using wrong administration route c. Administration to Wrong individual d. Dose/activity delivered by wrong mode of treatment e. leaky source

4) Dose to skin/organ of > 50 rem and 50% different from what it should be expected form the administration.

5) Any unintended permanent functional damage to tissue or organ, as determined by physician, that results form the administration.

In the following, the term "prescription" is understood to have the same meaning as the term "written directive” used in 10 CFR Part 35. The term "authorized physician" is interchangeable with the term "authorized user". B. Quality Management Program The term 'licensee' refers to the corporate entity named in the NRC license governing medical use of by-product material within the institutions served by the Radiation Oncology Center Physics Section. For procedures performed in Barnes-Jewish Hospital, the licensee is Washington University and Barnes Jewish Medical Center. 1. For each treatment modality (radiopharmaceuticals, high dose-rate brachytherapy and all other sealed-

source brachytherapy, including 90Sr eye-plaque therapy), specific policies or procedures shall be documented by each licensee to ensure that the QMP objectives of 10 CFR 35 are met. Specifically each licensee shall have:

-9-

a. Policies requiring an authorized user date and sign (or initial a written prescription prior to the administration;

b. Procedures to identify the patient by more than one method; c. Procedures to confirm that the plans of treatment are in accordance with the written prescription; d. Procedures requiring that, prior to administration, the person responsible for delivering the

treatment reviews the specific details of the written prescription (e.g. in radiopharmaceutical therapy, verify the radiopharmaceutical, dosage, and route of administration) and to not initiate administration if discrepancies in the specific details exist;

e. Procedures to record the radiopharmaceutical dosage or radiation dose actually administered.

2. Each licensee or designated ROC staff in conjunction with the licensee radiation safety officer shall

evaluate and respond to each medical event, within 15 days after discovery of the medical event, by: a. Assembling the relevant facts including the cause; b. Identifying what, if any, corrective action is required to prevent recurrence; and c. Retaining a record, in an auditable form, for three years, of the relevant facts and what

corrective action, if any, was taken. 3. Each licensee or designated ROC staff shall retain: a. Each written prescription; and b. A record of each administered radiation dose or radiopharmaceutical dosage where a written

prescription is required, in an auditable form, for three years after the date of administration.

4. Designated ROC staff or Radiation Safety office will review at least annually each applicable program area in behalf of the licensee: (1) radiopharmaceuticals, (2) HDR brachytherapy, and (3) other sealed source brachytherapy.

a. The review will include:

• An audit of a representative sample of patient treatments delivered since the previous audit. As a minimum, the licensee shall review at least 20% of all relevant patient cases for each of the following modalities: therapeutic radiopharmaceutical administrations, high dose-rate brachytherapy courses of treatment and all other sealed-source brachytherapy procedures (including Sr-90 eye plaque courses of treatment) performed in the institution. For each patient case reviewed, a comparison will be made between what was administered versus what was prescribed in the written prescription. If the difference between what was administered and what was prescribed exceeds the criteria for a medical event, the steps outlined in paragraph B.2. or C.1 will be followed.

• A review of all medical events that were identified in the reporting period.

b. To avoid persons reviewing their own work, an Assistant RSO from Radiation Safety conducts

annual QMP audits. If this is not possible, two people should work together as a team to conduct the review of that work. The Radiation Oncology Center QA and Radiation Safety Committee will regularly review the findings of each licensee's periodic review to ensure that the QM program is effective.

-10-

c. For each patient case reviewed, each licensee will determine whether the administered radiopharmaceutical dosage or radiation dose was in accordance with the written prescription or plan of treatment, as applicable. For example, were the following correct:

• For radiopharmaceutical therapy: the radiopharmaceutical, activity, and route of

administration prescribed will be compared to those recorded as actually having been administered. In addition, the measured activity of the sample administered to the patient will be checked against the prescribed activity.

• For each course of HDR brachytherapy the following will be checked:

- For the entire course of therapy, the radioisotope, treatment site, and total dose (or other relevant treatment specification quantity) recorded in the daily treatment record will be compared to the treatment prescription.

- For each individual treatment, the prescribed fraction recorded in the daily treatment

record will be checked against the prescription and the dwell time calculation and/or graphic treatment plan.

- For each individual treatment, the source strength assumed by the dwell time

calculation/graphic treatment plan will be checked against the then-current quarterly source inventory.

- For each individual treatment, the total dwell time recorded on the daily treatment

record and the remote-afterloader print-out will be checked against the total dwell time given by the manual calculation/graphic plan

• For all other individual sealed-source brachytherapy treatments, the following will be

checked:

- The recorded number of sources used will be compared to the loading diagram. - The strength of the sources, documented as having been used for treatment, will be

checked against the appropriate quarterly source inventory and/or the activity verified by the medical physics staff.

- The recorded total source strength will be verified. For temporary implants, the product

of recorded treatment time and total source strength (or, where applicable, prescription dose rate) will be checked against the total quantity of radiation prescribed. For manually loaded temporary implants, the time interval between recorded source removal and recorded source insertion will be checked against the total prescribed time.

- In the special case of Sr-90 eye plaque therapy, the recorded treatment site, applicator

used and total dose administered during the course of therapy, as documented in the treatment record, will be checked against the prescription. The dose rate and fraction size assumed by the treatment-time calculation, will be checked against the appropriate quarterly inventory and prescription, respectively. In addition, for each fraction, the dose delivered will be checked against the prescription and the recorded treatment time checked against the treatment-time calculation.

d. In addition, the following will be checked:

- That the patient has been identified by two methods - That an authorized user has signed (or initialed), dated and completed the prescription

-11-

- That for HDR brachytherapy, a physicist has reviewed the treatment/dwell time

calculations and associated graphic treatment plan, if any. That for other sealed-source brachytherapy, a physicist has reviewed the yellow prescription form and associated treatment plan if any.

e. For each patient case reviewed, the licensee will seek to identify any deviations from the written

prescription or the above outlined policies, the cause of each deviation, and the actions that would have prevented the deviation.

Any deviations or questions regarding the detailed implementation of the audit will be brought

to the attention of the appropriate Physics Staff. Remedial actions to avoid such deviations in the future will be considered. Remedial actions may include, but are not limited to, new or revised policies, new or revised procedures, additional training, increased supervisory review of work or pointing out to personnel the nature of the error made, if any.

The results of the annual QMP audits will be presented to the institutional Radiation Safety

Committee for review and action. 5. Each licensee will re-evaluate their QMP policies and procedures annually to determine whether the

program is still effective or to identify actions required to make the program more effective. The licensee shall provide the NRC Region III Office any revisions to this QMP plan within 30 days of implementation of the revised plan.

6. Program review results will be documented and will be available for NRC inspectors for three years.

The program review reports will be distributed within each institution to appropriate management and departments. Corrective actions for deficient conditions will be implemented within a reasonable time after identification of the deficiency.

C. Medical Events Procedures 1. For a medical event: a. The licensee shall notify by telephone the NRC Operations Center no later than the next

calendar day after discovery of the event. b. The licensee shall submit a written report to the NRC Region III Office within 15 days after

discovery. The written report must include the licensee's name; the prescribing physician's name; a brief description of the event; why the event occurred; the effect on the patient; what improvements are needed to prevent recurrence; actions taken to prevent recurrence; whether the licensee notified the patient, or the patient's responsible relative or guardian, and if not, why not, and if the patient was notified, what information was provided to the patient. The report must not include the patient's name or other information that could lead to identification of the patient.

c. The licensee should notify the referring physician and also notify the patient of the medical

event no later than 24 hours after its discovery, unless the referring physician personally informs the licensee either that he will inform the patient or that, based on medical judgment, telling the patient would be harmful. The licensee is not required to notify the patient without first consulting the referring physician. If the referring physician or patient cannot be reached within 24 hours, the licensee shall notify the patient as soon as possible thereafter. The licensee may not delay any appropriate medical care for the patient, including any necessary remedial care as a result of the medical event, because of any delay in notification.

d. If the patient was notified, the licensee shall also furnish, within 15 days after discovery of the

medical event, a written report to the patient by sending either:

-12-

1) A copy of the report that was submitted to the NRC; or 2) A brief description of both the event and the consequences as they may affect the patient,

provided a statement is included that the report submitted to the NRC can be obtained from the licensee.

e. Each licensee shall retain a record of each medical event for five years. The record must

contain the names of all individuals involved (including the prescribing physician, allied health personnel, the patient, and the patient's referring physician), the patient's social security number or identification number if one has been assigned, a brief description of the medical event, why it occurred, the effect on the patient, what improvements are needed to prevent recurrence, and the actions taken to prevent recurrence.

II. Procedure - Specific Quality Assurance Policies This section describes revised quality assurance guidelines and clinical procedures for sealed-source and Radiopharmaceutical therapy intended to supplement the procedures outlined in the Barnes-Jewish Radiation Oncology Center Brachytherapy Quality Assurance and Clinical Procedures Manuals. Their purpose is to assure compliance with the new NRC regulations regarding quality management and reporting requirements (10 CFR parts 2 and 35). Within our program and written documentation, the terms "prescription" and "written directive" are used interchangeably. A. Radiopharmaceutical Treatments

1. Before administering any therapeutic dosage of a radiopharmaceutical, or any dosage of I-125 or I-131 in excess of 30 Ci, a physician authorized to perform radiopharmaceutical therapy shall sign (or initial) and date a written prescription, i.e., written directive. The isotope, radiopharmaceutical (chemical and physical form), route of administration, and prescribed activity shall be clearly described in the prescription.

If treatment must be delayed in order to obtain a written revision to an existing written directive

and such a delay would compromise the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and revised written directive is dated and signed by the authorized user within 48 hours of the oral revision.

Also, a written revision to an existing written directive may be made for any diagnostic or

therapeutic procedure provided that the revision is dated and signed (or initialed) by an authorized user prior to completion of the treatment.

2. Before administering a radiopharmaceutical treatment the patient's identity shall be verified by at

least two of the following methods: Asking the patient's name, birth date, address, social security number, signature, the name on the

patient's ID bracelet or hospital ID card, the name on the patient's medical insurance card, the photograph of the patient's face, or other appropriate method. Other appropriate method may include questioning the Operating Room personnel if the patient was identified prior to being placed under anesthesia in addition to looking at the Operating Room Boards and monitors to make sure that the patient under anesthesia is the correct patient.

Fulfillment of the requirement should be documented on the general radiopharmaceutical QA

check off list and any other location where it is required (i.e. “prescription form”)

-13-

3. Prior to administering the radiopharmaceutical, the brachytherapy technologist shall verify that the pre-treatment checks on the “general radiopharmaceutical administrations check off list” and the “specific radiopharmaceutical administration check off list” if available, are completed.

4. Prior to administering a radiopharmaceutical treatment to a patient, the technologist and/or

assisting physician shall review the written prescription to verify that the proposed treatment is in accord with the prescription and other treatment documentation. Specifically, the isotope, radiopharmaceutical (chemical and physical form), proposed route of administration and the recorded measured/verified activity shall be checked against the prescription. The recorded measured/verified activity shall be within 10% of the prescribed activity.

5. Activity of Record: The Manufacturers/ radiopharmacy supplier activity as documented on the

package label and as verified by way of dose calibrator measurements shall be compared to the prescription activity. The activity determined by the dose calibrator assay must agree within better than ±3-5% of the manufacturer/radiopharmacy stated activity; and the manufacturer/radiopharmacy stated activity must agree within ±10% of the prescribed activity. When this is met the Activity of Record is that provided by the manufacturers/radiopharmacy. This is applicable for both photon emitting and beta emitting isotopes.. If this is not met, an investigation on to the cause of discrepancy must be performed before administering the dose. If the explanations for the discrepancy can not be found in a timely manner, and if our dose calibrator daily quality assurance tests are satisfactory, the activity of record shall be that measured by our dose calibrator. The authorized physician must be contacted to inform of occurrence and to provide guidance on weather to proceeded with the administration or to postpone. If the authorized physician approves the administration of the amount of drug measured, a prescription modification must be made and documented immediately. An investigation and remedial actions must be undertaken to resolve further issues. Dose calibrators used for photon-emitting radiopharmaceuticals will meet the requirements outlined in 10 CFR 35.60.

For radiopharmaceuticals emitting only particles for which NIST traceable calibration

standards are not readily available, the unit dosages of the manufacturer may be considered Calibration checks against appropriate historical or vendor-established standards are strongly encouraged.

5. For complex radiopharmaceutical administrations (BEXXAR ,SIRTEX, TMI , MIBG) that requires

the involvement of multiple disciplines and departments within our hospital/ institution, specific procedures should be written in order to comply with the requisites of this section; NRC regulatory guidelines and to address specific drug ordering and dispensation procedures, determination of activities to administer, determination of activities post administration, source ordering and receipt, actual drug delivery technique and procedures and logistics.

6. The individual administering the therapy shall seek guidance from a physician authorized to perform

brachytherapy or a physicist (as appropriate) if the treatment prescription and/or treatment documentation is not understood before administering treatment.

B. High-Dose Rate Brachytherapy 1. Before administering an HDR treatment the brachytherapy technologist (or other operator) shall

verify the patient's identity at least by two of the following methods: Asking the patient's name, birth date, address, social security number, signature, the name on the

patient's ID bracelet or hospital ID card, the name on the patient's medical insurance card, the photograph of the patient's face or other appropriate method.

-14-

Fulfillment of the requirement should be documented on the HDR QA checkoff list and any other location that is required.

2. Before administering an HDR treatment, a physician authorized to perform brachytherapy

procedures shall sign (or initial) and date a prescription. The prescription shall include: the isotope used, site of treatment, number of treatments, prescribed dose (or other prescription quantity) per fraction and total dose (or other prescription quantity).

If treatment must be delayed in order to obtain a written revision to an existing written directive

and such a delay would compromise the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and the revised written directive is dated and signed by the authorized user within 48 hours of the oral revision.

Also, a written revision to an existing written directive may be made for any diagnostic or

therapeutic procedure provided that the revision is dated and signed (or initialed) by an authorized user prior to completion of the course of therapy.

3. Where appropriate, radiographic imaging shall be used to define the dwell positions that are to

be treated, anatomic location of the applicators, and/or relative positions of the applicators or dwell positions. Anatomical positioning of fixed-geometry or radio-opaque applicators (e.g., molds or shielded endocavitary applicators) will be confirmed using appropriate surgical, visual or imaging techniques. The accuracy of source positioning within such applicators shall be confirmed by appropriate techniques before initiating their use in patient therapy.

4. Prior to each treatment, a physicist shall review the prescription, simulation films or other

localization data, graphic treatment plan (if available before treatment) and/or dwell-time calculations and remote afterloader treatment program print out.

The physicist shall verify:

- data input to the treatment planning computer or manual calculation including prescribed dose, active source positions, and source strength.

- accuracy of dose calculations including dwell-time calculations. - accuracy of information transfer to HDR remote-afterloading device.

The physicist shall initial the treatment record, the computer treatment plan or manual

calculation and the HDR treatment program printout to document this review. Graphic treatment plans are not appropriate or not required for some treatments. If medically appropriate, treatments normally accompanied by graphic treatment plans may be administered on the basis of manual calculations and the plan prepared later.

5. Before administering an HDR treatment, the technologist shall verify that:

- Patients identity has been confirmed - the treatment program agrees with the written prescription, with regard to treatment site,

isotope, total dose, dose per fraction and treatment modality (i.e., HDR). - that the programmed sequence of source positions and dwell times agrees with the

previously-reviewed HDR graphic treatment plan or manual calculation. - that the HDR treatment channels are correctly connected to the corresponding applicators.

-15-

The technologist shall seek guidance from a physician authorized to perform brachytherapy or a physicist (as appropriate) if the treatment prescription and/or treatment documentation is not understood before administering treatment.

6. Following completion of each fraction, the technologist shall document the treatment on the

daily treatment record. Graphic treatment plans prepared after treatment administration should be promptly reviewed by a physicist.

7. Prior to implementing a previously-unused treatment planning program or any other equipment

to support clinical procedures, a brachytherapy physicist will test the software and hardware for safe use and accuracy.

C. Low Dose-Rate (LDR) Brachytherapy (Eye Plaques, Prostates Implants, Lung I-125, IR-192 Implants)

1. Before administering an LDR treatment, the brachytherapy technologist or other operator shall

verify the patient's identity by at least two of the following methods: Asking the patient's name, birth date, address, social security number, signature, the name on the

patient's ID bracelet or hospital ID card, the name on the patient's medical insurance card, the photograph of the patient's face or other appropriate method. Other appropriate method may include questioning the Operating Room personnel if the patient was identified prior to being placed under anesthesia in addition to looking at the Operating Room Boards and monitors to make sure that the patient under anesthesia is the correct patient.

Fulfillment of this requirement should be documented on the LDR QA check off list and in any

other documents where it is required. (i.e. prescription form) 2. Before administering an LDR brachytherapy treatment, an authorized physician shall sign (or initial)

and date a written prescription and if available, treatment plan. If the prescription, and if available, treatment plan, are not signed by the authorized physician at the time of implant, a verbal authorization shall be obtained and the authorized physician must sign the prescription and treatment plan by the next calendar day.

3. Prior to loading sources into the applicators, the prescription and/or treatment plan shall, at

minimum, specify the isotope, source strength, number of sources, applicator type (catheters/needles/plaques) and loading patterns.

4. The source strength shall be verified by way of measurement and compared against the prescribed

and if available, treatment planned source strength, prior to loading any applicators and/or implanting the sources. Verification of the source strength shall be by way of measurement using the dose calibrator for loose sources and/or calculations based on manufacturer specified activity for sterile sutured sources.

5. Source loading patterns within applicator shall be verified by visual inspection or any other

appropriate method before implanting the applicators into the patient. 6. Before completion of the treatment, the prescription shall be completed, including, in addition to the

above, the treatment time, total prescribed dose or other prescription quantity (e.g., mg-hrs, total absorbed dose to an isodose surface or reference point, or total treatment time) and the treatment site.

a. In the special case of eye plaque brachytherapy, the actual plaque extraction date and time

and the actual delivery time, in hours, shall be recorded on the prescription form. The technologist shall determine if the delivered amount of time is within 3% of the prescribed time. If this is not the case, the brachytherapy technologist shall inform physics and the authorized user of the events. The authorized user and physics shall either make the

-16-

appropriate modifications to the prescription or classify the event as a medical event. If the event is classified as a medical event, then we proceed as indicated above in the medical event section of this manual.

7. In the special case of 90Sr eye plaque therapy, the prescription shall include the treatment site, radioisotope, activity, and number of fractions, dose (or other quantity) per fraction, and total dose (or other quantity).

8. If treatment must be delayed in order to obtain a written revision to an existing written directive and

such a delay would compromise the patient's health, an oral revision to an existing written directive will be acceptable, provided that the oral revision is documented immediately in the patient's record and revised written directive is dated and signed by the authorized user within 48 hours of the oral revision. Also, a written revision to an existing written directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed (or initialed) by an authorized user prior to completion of the treatment.

9. Where appropriate, radiographic imaging shall be used to define the dwell positions that are to be

treated, anatomic location of the applicators, and/or relative positions of the applicators or dwell positions. Anatomical positioning of fixed-geometry or radio-opaque applicators (e.g., molds or shielded endocavitary applicators) will be confirmed using appropriate surgical visual or imaging techniques. The accuracy of source positioning within such applicators shall be confirmed by appropriate techniques before initiating their use in patient therapy.

10. Prior to completion of treatment, a physicist shall review the prescription, simulation films or other

localization data, graphic treatment plan (if available before treatment) and any relevant manual calculations. The physicist should verify:

- accuracy of data input to the treatment planning computer and/or manual calculations

including prescribed dose, prescription quantity, isotope, source type, source strength and source loadings and applicators types used.

- Any manual or computer-aided dose calculations impacting on the accuracy of dose

delivery. - Programming of remote afterloading device (if any). In the case of a permanent implant, treatment calculations, if available and required, shall be reviewed as promptly as possible after source insertion.

11. Prior to inserting sources into the patient, the technologist and/or assisting physician shall review the written prescription to verify that the proposed loading is in accord with the prescription and other treatment planning documentation. Specifically, the radioisotope, number of sources, source strength and loading patterns will be confirmed.

12. The technologist and/or assisting physician shall seek guidance from a physician authorized to perform brachytherapy or a physicist (as appropriate) if the treatment prescription, associated treatment documentation or procedure is not understood before administering treatment.

13. Any changes in loading, prescribed dose, or total treatment time deemed advantageous to the

medical management of the patient by the authorized physician shall be documented on the treatment record, signed (or initialed) and dated by an authorized physician. Such revisions to the written prescription must be made before completion of the treatment.

14. Prior to implementing a previously-unused treatment planning program or any other equipment to

support clinical procedures, a brachytherapy physicist will test the software and hardware for safe use and accuracy.

-17-

B. Other General QMP Policies

1. All radiopharmaceutical therapy and LDR brachytherapy patients failing to meet NRC criteria for

release (of radioactive patients) to the public shall be housed in private hospital rooms which will be treated as restricted areas during the treatment. All nursing personnel attending such patients shall have received appropriate radiation safety and QA in-services within the previous 12 months.

2. QA checklists documenting compliance with QMP and other important QA endpoints shall be

completed by the physicist or designee for each patient and permanently retained in the ROC QA office.

3. A Radiation Oncology physician should be present during the applicator insertion part of a

brachytherapy procedure.

4. A physicist or designee shall be on call to handle safety and technical problems whenever radioisotope patients are hospitalized.

5. A radiation oncology resident, backed up by an attending physician authorized to perform

brachytherapy procedures, shall be on call whenever radioisotope patients are hospitalized. On-call resident physicians responsible for source removal and associated safety duties shall have completed radioactive source handling training.

IV. HIGH DOSE-RATE BRACHYTHERAPY QUALITY ASSURANCE

A. General Aspects of HDR Brachytherapy Quality Assurance:

Physical QA endpoints encompassed by this protocol are:

1. Positional Accuracy: The fundamental test of HDR intrinsic positional accuracy shall be comparison of the actual HDR source position with that of the dummy source simulator or of radiographic markers used to select active dwell positions for the applicator system. Positional accuracy of all applicator systems and simulation markers as well as accuracy of the autoradiography procedure shall be verified. The NRC requires positional accuracy of 1 mm. However, the Nucletron microSelectron/HDR remote afterloader is capable of sustaining this level of accuracy only under extremely limited circumstances. Clinical source localization procedures should satisfy an accuracy criterion of 2 mm. Only if (a) non-remediable engineering deficiencies in treatment accessories are at fault and (b) the responsible radiation oncologist accepts a larger margin of error can clinical treatments failing to meet this criterion continue.

2. Accuracy of Source Strength: Source strength values for clinical treatments shall be based upon

values measured by each institution. No NIST standard for HDR Ir-192 currently exists. An interim standard, based on the secondary in-air calibration procedure recommended by Goetsch (Med. Phys 18; 462-467, 1991) has been available from the ADCL at University of Wisconsin for calibration of re-entrant well chambers for HDR source strength determination. Such a chamber is used at the ROC as secondary standard. This chamber must have an ADCL calibration no older than 2 years. Appropriate checks of constancy, geometry dependence, and ion recombination/linearity of this chamber shall be made. The quantity, air-kerma strength, with units of cGy.m2.h-1, shall be used for calibration, inventory and treatment planning purposes. An accuracy of 2% relative to NIST standards should be achievable. All discrepancies larger than 3% shall be investigated by a physicist.

Following initial calibration of the source with the secondary measurement standard, the measured SK shall be checked against the vendor's calibration certificate. In addition, a tertiary calibration apparatus, consisting of an electrometer and detector independent of the secondary measurement,

-18-

should be performed to confirm the secondary measurement. An Authorized HDR Physicist must review and sign off on quarterly calibrations.

3. Timer Accuracy: An independent time standard shall be used to verify absolute dwell time

accuracy. Farmer ion chamber measurements in a phantom at appropriate source-detector distances can be used to measure dwell time accuracy relative to timer setting as well as timer linearity, end effects of finite source transfer speed and source transfer average velocity. A temporal accuracy of 2% should be achievable.

4. Radiation Safety: Designated interlocks and emergency responses shall be tested. Exposure rates

to the general public and employees shall conform to the limits set fourth in 10 CFR part 20. It is the physicist's responsibility, in collaboration with the Radiation Safety Officer, to minimize both legal and regulatory liability of the institution by designing and enforcing appropriate technical treatment practices and documentation standards.


Before clinical implementation of an HDR device, the following measurements and checks, or their functional equivalents, shall be carried out. A commissioning report describing the test outcomes and any variations from the recommended test procedures shall be submitted to the Director of Physics for review. Reporting requirements for the required annual QA review are identical.

The emphasis in the one-time QA activity of commissioning is exhaustive and redundant assessment of machine function, including development of specialized quality assurance apparatus such as a multi-channel autoradiography cassette, source calibration jigs, and phantoms for temporal accuracy and daily output/timer checks. In addition, QA documentation, treatment procedures and treatment documentation shall be developed as needed. The annual review procedures emphasize upon verifying of constancy through time of important operational parameters. Written Annual and commissioning reports are required. In addition to the Quarterly Review procedures, an annual review includes:

1. Inter-comparison of the secondary calibration standard with the independent tertiary calibration

standard used for daily source strength verification measurements. 2. Comparison of all treatment tubes, applicators, simulation sources, and autoradiography cassettes

against primary positional accuracy criteria. Radiographic examination of all shielded applicators. 3. Correct operation of the HDR treatment planning system. Tests should include: dose calculation

algorithm verification, geometric accuracy of peripherals, accuracy and correctness of benchmark plans representing each major optimization and implant geometry reconstruction algorithm, and correctness of customization file information.

C. Quarterly QA Protocol

The quarterly QA protocol shall be used every time a new source is installed. The tests shall be performed by a physicist or designee. Results of the tests shall be reviewed by an Authorized HDR Medical Physicist before returning the system to clinical use. The tests include:

1. Source calibration using a current secondary standard. 2. Spot check of calibration using independent instrumentation (different chamber and electrometer)

as well as comparison of measured Sk against vendor value. 3. Verification of selected interlocks, emergency responses and facility safety features. The

exposure rate 1 m from the HDR head with the source retracted must be measured and shall not exceed 0.25 mR/h.

-19-

4. Positional Accuracy: a. Direct check of HDR source position against source simulator or radiographic marker b. 18 channel-staggered auto-radiographs 5. Timer accuracy and linearity. 6. Comparison of measured source strength against HDR computer, RTP and inventory. 7. Independent review of report by an authorized HDR physicist, in the case that such a physicist did

not perform the QA tests.

D. Daily QA Tests Daily QA can be performed by a technologist or dosimetrist and shall be performed within the

24-hour period preceding each clinical treatment. QA protocol consists of reviewing critical interlocks, emergency responses, treatment status indicators, and safety features. In addition, the Radiation Oncology Center protocol requires an independent spot check of timer accuracy. This can be performed by timing, with a stopwatch, the duration of "Beam On" light during a programmed source exposure or an ion-chamber source output test. The latter test is performed currently at the ROC as part of the daily HDR test. If patient-specific autoradiographic treatment program verification is not performed, an initial autoradiographic check of positional accuracy shall be completed.

E. Computer Treatment Planning Systems

Treatment planning software used for calculation of dwell times and/or dose distributions shall be

reviewed for accuracy, correct function and consistent clinical implementation upon initial acquisition, major software revisions or updates, and at annual intervals thereafter. The QA review should include the items listed in the following table. The annual treatment planning system QA review may be included as part of the HDR remote afterloader annual review.

HDR Brachytherapy RTP Quality Assurance

Function Benchmark Data Frequency Verify geometric accuracy of I/O peripherals: digitizer, CT or ultrasound interface, and plotter

Digitize/plot pattern of known geometry. For CT/US, image and reconstruct phantom implant.

Annually

Verify input parameters for all precalculated single-source arrays

Published recommendations, source vendor's mechanical drawings

Initially, annually

Verify point calculations for all source files

Published dose-rate tables, Manual calculations or output of independent RTP

Initially, annually, new software version or source identify

Accuracy of single-source isodoses

Point source output Initially New software version

Accuracy of multiple-source isodose contouring

Point source data for symmetric source arrays

Initially New software version

Accuracy of plan rotation matrix

Constancy of point doses, source positions, and isodoses under repeated orthogonal rotations for symmetric source arrays


Consistency of printed Assumed input parameters Every clinical use

-20-

plan documentation Accuracy of coordinate reconstruction

Radiograph phantom with known catheter geometry

Initially new software version implementation of new feature

Accuracy of electronic downloading of treatment parameters to HDR unit

Comparison of treatment unit and planning system printed output

Initially new software version Each treatment

Dose volume histogram Use isotropic point source of segment of ling source allowing analytic calculation of DVH


Optimization software Run series of test cases based upon idealized implant geometries of various sizes. Develop a sense of what optimization does to an implant compared to uniform loading before trying it on patients

Initially. Spot check when software changes by duplicating old cases

Overall system test Run series of standardized plans to globally test all clinically-used features

Initially New software version Annually

F. Treatment Specific QA

Daily QA requirements and personnel assignments are specified in detail by the appended documents. Each HDR facility must conform to the documentation requirements inherent in the following forms. The Procedure Checklist (or its functional equivalent) should be used.

1. Procedure Checklist This is the master list, which specifies the flow of the procedure as well as critical

information-gathering, mandated checks, documentation requirements and QA procedures. The following guidelines shall be observed.

a. Prescription (Satisfying NRC "written directive" requirements) to be completed and signed by

an attending physician authorized to perform HDR brachytherapy procedures by the Radiation Safety Committee or NRC Medical Use license.

b. Physicist review of treatment plan and/or dwell time calculation, prescription, simulation

information, autoradiograph and HDR TCS pretreatment record. The accuracy of all computer-assisted dose/dwell time calculations shall be independently assessed.

c. Autoradiographic verification of dwell positions, treatment lengths and step sizes is

recommended for complex multi-channel treatments. d. An authorized user and an authorized HDR medical physicist shall be present during the start

of all HDR treatments. An authorized HDR medical physicist and a physician trained in the emergency removal of applicators shall be physically present (within audible range of normal human speech) during the treatment. A technologist should be available to set up the patient and operate the unit.

e. The attending physician reviews and signs the graphic isodose plan or manual calculation

prior to initiating treatment. f. Prior to initiating treatment - the therapist shall redundantly confirm the patient's identity and check that the treatment

chart and prescription bears the same name

-21-

- the therapist shall confirm that the source strength, fraction size, and total dose on the prescription form agree with the treatment calculation.

- the therapist shall confirm that the prescription has been signed by an attending physician and that both physicist and physician have signed off on the treatment plan/calculations review

- the physicist and radiation oncology physician shall verify and initial that the dwell times and positions programmed into the remote afterloader agree with the treatment plan or calculation.

h. After completion of treatment - Complete source retraction shall be confirmed by the independent area radiation monitor

and by means of a hand-held survey meter. The brachytherapy technologist shall document the administered treatment in the HDR Brachytherapy Treatment Record and ensure that the QA check-off list and other documentation are complete. If the source is not fully retracted into the shielded safe, the emergency procedures must be implemented.

2. Prescription Form This form contains the prescription for the entire HDR course of treatment, a treatment diagram,

and a section to be completed and signed by personnel involved in each fraction. It allows tabulation of cumulative doses similar to the external beam daily treatment record.

3. Physics Review (HDR Treatment Review Checklist) The physics review is the centerpiece of individual treatment QA and is intended to be

comprehensive. It shall be performed by a physicist and include the following elements: a. Review of treatment documentation relative to prescription and physicist's understanding of

clinical intent. The intent is to encourage physicist consultation with the Radiation Oncologist prior to the OR procedure. Thus treatment planning documentation should be reviewed in the context of the global treatment strategy and should focus on adequacy of total minimum target dose, target coverage, dose homogeneity, and dose/volume tolerances of normal tissue.

b. Positional accuracy: Review of treatment plan, autoradiograph (if available) and HDR printout

against simulation films. An "HDR Localization Verification" form has been developed to facilitate this review. The purpose of this review is to ensure correct matching of catheters to channels and correct calculation of indexer lengths and active dwell positions. Data acquired for this purpose in the simulator room should be measured by two persons working together (allowing one to check the other) and recorded on the appropriate form.

c. Review of the usual input/output parameters of the treatment plan, including agreement of

dwell times on plan with the HDR printout. d. Independent check of computer dose calculations and dwell times. 4. Additional Operational Guidelines

a. A copy of these procedures must be placed at the HDR unit console b. The treatment unit remains chained to the wall and that the console key is secured when the

unit is not attended by appropriately trained individuals. Personnel trained in HDR unit operation are always present during a patient treatment.

c. Only the patient will be in the treatment room during exposure of a high dose rate source

-22-

d. Use of the device is limited to human radiotherapy, experimental irradiation of biological specimens of animal origin, physics quality assurance, or dosimetry measurements. Non-human experimental irradiation projects must be approved by the Radiation Safety Committee and must use a trained operator.

e. Both an extended range calibrated GM detector and a calibrated ion chamber survey meter

must be available during HDR unit use.

V. RADIOPHARMACEUTICAL THERAPY QUALITY ASSURANCE Recommendations are expressed in terms of should and shall. Use of “Shall” indicates that the recommendation is an essential ROC quality assurance guideline, which must be followed. Use of 'should' in a recommendation implies it is to be followed when practicable. In practice, it is expected that any significant deviation from "should" require a justification.

A. Ordering of Radiopharmaceuticals

1. General Procedures Because of the variety of radiopharmaceuticals administration and the complexity of such

administration the radiopharmaceuticals may be ordered by a) authorized users b) trained authorized medical physicist as required for a particular scheduled procedure c) trained brachytherapy technologist as required by a particular procedure and under the written or verbal consent of the authorized user c) trained nursing staff ,as required by a particular scheduled procedure and ONLY when receiving a written request from medical physics. Authorized users are approved and designated by the Radiation Safety Committee. The other personnel (Brachy RTT and Nursing) should be trained by the authorized medical physicist in the aspects of proper ordering the radiopharmaceuticals. For all administrations, an "Isotope Request Form" should be prepared. This form shall contain the names of the patient and the authorized user, the dates of the request and of administration, and the type and activity of radiopharmaceutical desired and the expected date of arrival. The brachytherapy technologist or physicist shall confirm orally with the physician the information on the Isotope Request Form. The Isotope Request Form shall be signed by the authorized user, if no verbal consent exist; before ordering the radiopharmaceutical. The form shall be faxed to the radiation safety office to alert them of incoming radioactive material. All radiophamacutical orders shall be placed such the receipt address will be that of the radiation safety office. No orders shall be placed in such a manner as to have the radiopharmacutical delivered directly to the Radiation Oncology Department. Packages shall be delivered by radiation safety office personnel to the source room at the siteman cancer center, radiation oncology department, where they will be opened and assayed.

2. Additional Considerations The radiopharmaceutical Metastron (Sr-89 Chloride) must be ordered at least one day prior to the

date of administration, since the vendor (Medi-Physics) is nonlocal. If possible, I-131 and P-32 radiopharmaceuticals should also be ordered at least a day before administration. However, since the vendor (Mallinckrodt) is local, it is usually possible to obtain these radiopharmaceuticals on the same day as they are ordered. Thus, in most instances, it will be possible to order and administer I-131 and P-32 on the same day. Samarium-153 (Quadramet) can be administered only between 11:00 A.M. on Wednesday and 11:00 A.M. on Friday. The Quadramet should be ordered by Friday preceding the week of the administration.

Legally, vendors of radiopharmaceuticals are considered pharmacies. Once radiopharmaceuticals

are dispensed and shipped, they cannot be reused by vendors, even if returned unopened. Therefore, if a radiopharmaceutical is ordered and not used, the entire cost will be borne by the

-23-

hospital. Accordingly, it is important that patient consent and eligibility for radiopharmaceutical therapy be confirmed before the radiopharmaceutical is ordered from the vendor.

B. Radiopharmaceutical Receipt and Handling

1. General Radiation Safety Considerations Exposures to the general public and to employees must conform to the limits set forth in 10 CFR

part 20. Other requirements pertaining to posting, training, documentation, radiopharmaceutical inventory, instrument calibration, etc. must conform to 10 CFR part 35 requirements and individual license commitments.

2. Contamination Control and Radiation Surveys

Before packages arriving from the Radiation Safety Office are opened, handlers shall use rubber

gloves to protect themselves and others from contamination by radioactive material on the surfaces of the shielded container (e.g., the "pig" for I-131) and of the vial itself. In all cases, the "work area” shall be covered with absorbent paper. In cases were vials are opened or syringes are prepared (Sr-89, P-32, Sirtex Y-90) in the source room, the surfaces of the L-Block, floors and counters shall also be covered with absorbent material. Areas that may become contaminated where radiopharmaceuticals are administered shall be covered with absorbent material prior to the administration. Additional precautions particular to a specific radiopharmaceutical dispensation or administration procedure may be performed, if necessary, in order to provide for a safer environment and reduce the probability of contamination.

If it is necessary to divide a unit I-131 NaI dose, this shall be performed in the Nuclear Medicine

Radiopharmacy where an appropriately certified fume hood is available. Specific dispensation procedures for any other radiopharmaceutical shall be written and followed before dispensing any radiopharmaceuticals. Dispensation of radiopharmaceutical that do not require the use of fume hoods (SIRTEX Y-90) may be performed in the source room.

Before opening any boxes or canisters that may contain radiopharmaceutcials they must be

inspected for structural integrity and for the documentation of inspection by radiation safety office (YELLOW source receipt inspection sheet attached to the box/canister) . This will assure that the box or canister containing the radiopharmaceutical is compliant with Nuclear Regulatory Commission and Department of Transportation specifications and is not contaminated.

Radiation surveys shall be taken in the work , source assay, area prior to opening the package

containing the radiopharmaceutical. A final survey shall be obtained after completion of the check-in/assay procedure to assure that surfaces where not contaminated. The outer surface of the lead pigs, as well as that of the inner vials or syringes, shall be wipe tested. Gloves should be worn during this procedure. Should the removable contamination from the lead pig exceed, 2000 dpm/ 100 cm2, the pig shall be marked as "contaminated," handled only with gloved hands subsequently, and stored in a sealed Zip-Lock bag after treatment.

Radiation survey of work areas and controlled administration areas (i.e. I-131 administration

room, brachytherapy center, SCC) shall be performed on a daily basis. Contamination surveys (i.e.Wipe testing) of controlled administration areas and work , assay, areas shall be performed on a weekly basis.

Surveys shall be conducted with a Geiger counter. In comparing work area surveys taken before

and after radiopharmaceutical assay or preparation, a "Floating Trigger Level" (a difference of measured exposure rates) of 2 mR/hr or 8000 c/m shall be employed as a criterion for defining contamination of the work area by the radiopharmaceutical. If the floating trigger level is exceeded, the absorbent paper shall be removed, disposed of as radioactive trash and a second (or third) survey repeated. If the floating trigger level is still exceeded, the area shall be cleaned until

-24-

the difference alluded to above has been satisfactorily reduced. If needed, assistance from the Radiation Safety Office will be requested.

Surface contamination surveys shall be performed by wipe testing the areas where possible

contamination exists. The wipe tests shall be “read/measured” on the CAPINTEC CAPRAC well counter in the Source Room. The constancy of the CAPRAC well counter shall be verified on a daily basis prior to use. The constancy of the CAPRAC shall be verified by using a Cs-137 or Ba-133 or any other available and acceptable constancy check source. If deviations of more than 5% from nominal values are found the CAPRAC shall not be used to determine contamination levels. In the absence of functionality of the CAPRAC, the radiation safety office well counter shall be used to measure and determine contamination levels from “wipes”.

Surface contamination surveys of controlled administration areas (i.e. I-131 administration room,

brachytherapy center, SCC) shall be performed on a weekly basis. Surface contamination surveys of uncontrolled areas shall be performed immediately after administration of the radiopharmaceuticals. For controlled areas a trigger level of 2000 cpm or dpm will indicate contamination. For uncontrolled areas a trigger level of 200 dpm or cpm will indicate contamination.

If the surface contamination trigger levels in uncontrolled areas are exceeded, the area will not be

released for general use until decontaminated. Decontaminiation shall be performed first by radiation oncology brachytherapy staff. A re measurement of the area will be performed to asses contamination levels after decontamination. If levels are still above trigger levels, the radiation safety office will be contacted for assistance.

The sensitivity of all survey meters employed shall be evaluated prior to their use in the surveys

through their response to a known check source under set geometric conditions. The results of this "constancy” check should be recorded in a logbook (containing the date, meter model and serial number, meter response, and initials of person conducting the check).

Surveys for contamination by I- 131 and other gamma emitters shall be carried out with the end cap of the cylindrical probe of the Geiger counter in place. Measurements shall be made above selected points on the work area surface. The axis of the probe shall be horizontal, parallel to and 5 cm above the work area surface. Surveys for contamination by Sr-89, P-32 and other beta emitters shall be carried out with the end cap of the cylindrical probe removed. The axis of the probe will be vertical, perpendicular to the work-area surface. The end of the probe will be 5 cm above the work-area surface, at the points indicated.

C. Determination of Activity of Radiopharmaceuticals

The activity of dosages shall be determined/verified with a dose calibrator, in accordance with the procedures indicated in 10 CFR 35 1. Linearity and constancy of dose calibrator The Radiation Safety Office shall evaluate the linearity of the dose calibrator system employed to

determine the activity of radiopharmaceutical samples once every quarter. The constancy of system response shall also be confirmed prior to each measurement of radiopharmaceutical activity. This "constancy" check shall be carried out by recording the response of the system to a Cs tube source with a NIST-traceable calibration and comparing the source strength determined from the measured response with the appropriately decayed strength of the calibrated source. Deviations from constant and linear system response of less than 5% will be considered acceptable.

-25-

2. Accuracy of dose calibrator The accuracy of the dose calibrator system for assay of photon-emitting radionuclides shall be

evaluated upon installation and at least annually thereafter by assaying, for each radionuclide photon energy of interest, two calibrated (NISTtraceable) sealed sources that bracket that energy. For I-131, the sources employed shall be NIST-traceable Ba-133 and Cs-137 sealed sources, obtained from the Radiation Safety Office. A system accuracy of better than 5% will be considered acceptable.

3. Activities of Record for Gamma and Beta Emitters The "activity of record" for dosages of any radiopharmaceuticals shall be that stated by the

manufacturer AND as VERIFIED within 5% by our Dose calibrator measurements. Differences of vendor and source room-dose calibrator determined activities of more than 5% shall be brought to the attention of the vendor. Differences between the MFRG/radiopharmacy and the prescribed activity of more than 10% shall NOT be administered unless indicated by the authorized user.

NIST-traceable beta activity standards are not readily available. Given the absence of

independent calibration of the Cs room dose calibrator for beta emitters (e.g., Sr89 and P-32), the activity of record shall-be that indicated by the vendor, decayed to the date of administration. A "relative calibration factor", determined from the response of the dose calibrator to a given, vendor-specified activity of e.g., Sr-89 and P-32 radiopharmaceuticals, should be used to check the consistency of the dosages obtained thereafter. Differences of vendor and Cs room-dose calibrator determined activities of more than 20% should be brought to the attention of the vendor.

4. Criteria for Administration of Activity of Record

As discussed in 10 CFR 35, administration of an activity of radiopharmaceutical that differs from the prescribed activity by more than 20% (smaller or larger) constitutes a "medical event" . Accordingly, the activity of record of shall be administered to the patient only if it differs from the activity prescribed by the authorized user by less than 10%. The activity of record can be reduced or increased as needed by reducing or increasing the volume of radiopharmaceutical administered (additional radiopharmaceutical can be ordered). If desired, compliance with NRC regulations can also be obtained by appropriate modification of the prescription by the authorized user. Such modification shall be put in writing and signed by the authorized user.

D. Administration of Radiopharmaceuticals

D.1 Patient Release Criteria

According to NRC regulations (10 CFR 35.75), radioactive patients maybe released from medical confinement, if the total effective dose equivalent (TEDE) to any other individual from the released patient is not likely to exceed 5 mSv (500 mRem). There are several patient release calculations forms that use the formalism of NUREG 1556(Regulatory Guide 8.39) to demonstrate compliance with these regulations. These forms may be updated on a need basis. The particular assumptions and equations for calculating the dose from released patients depends on the particular radiopharmaceutical form and particular metabolic pathways (clearance rates) for the drug. Any document that is used to determine that a patient meets release criteria shall be kept within the patient’s record and if necessary a copy will kept in the Brachytherapy Center , Siteman Cancer Center , Source Room. If the TEDE to the general public is estimated to be greater than 100 mrem, or if the patient is release on a measured exposure rate at 1 meter, instructions on how to maintain doses to the general public ALARA will be provided to the patient. A record of these instructions shall be kept within the patient’s record.

-26-

Patients that can not comply with release criteria will be admitted as inpatients on any room as approved by the Radiation Safety Committee. As of the writing of this manual, the room available is the 4476 East Pavillion Barnes Jewish Hospital. The rooms that are used to admit and house patients that contain any form of radiopharmacutical shall have the following characteristics: 1) Be a private room with private sanitary facility 2) Can not be carpeted; must be tile or linoleum floors 3) if necessary, shielded, in order to maintain dose rates in uncontrolled areas to less than 2 mr/hr and doses of less than 100 mrem/year. D.1.a Release of I-131 NaI (Sodium Iodine Oral) patients

For patients administered less than 250 mCi of I131 NaI, the dose (TEDE) to the general public is estimated based on the calculation formalism and assumptions made by Reg Guide 8.39(NUREG 1556). If patients are administered 250 mCi or more, patient released dose (TEDE) is estimated based on the calculation formalism and assumptions made in Reg Guide 8.39(NUREG 1556) and a measurement of exposure rate at 1 meter from the patient.

D.1.b Release of I-131 BEXXAR patients

For patients administered I-131 BEXXAR solution, patient release shall be based on calculations that utilize measured exposure rates at 1 meter from the pateint and the residency times as measured on a per patient basis. This formalism was developed by Siegel et al. The forms shall be filled out and placed in the patients chart.

D.1.c Release of I-131 TM601 patients

The administration of this radiopharmacetucal is on a fractionated basis. A maximum of 40 mCi of I131 and 6 fx is allowed. For each of the administration the limit of 7 mr/hr will be applied for release. Because the cumulative effect of the TEDE, calculations were performed to estimate the TEDE to the general public form 6 x 40 mCi administrations. The estimates indicate that releasing patients at a 7 mr/hr at 1 meter on each fraction, and doing this for all 6 fractions, will deliver a cumulative TEDE in the order of 500 mrem. The estimates were performed following the guidelines of NUREG 1556 ( Reg Guide 8.39) and using average residency/ drug clearance times as determined by measurements made for a set of patients under protocol and as verified by the first two patient fractions administered.

D.1.d Release of any other photon emitting radiopharmaceutical patient

New forms of radiopharmaceuticals are being introduced frequently. Each radiopharmacutical has a characteristic clearance rate. To comply with patient release criteria of 10CFR35.75, the NUREG 1556, appendix U (i.e. REg Guide 8.39) equations and methodology will be used as the basis to estimate TEDE. The equations may need to be slightly modified depending on available data related to the effective half life or radiopharmaceutical clearance rates (residency times). For each patient, the estimates of TEDE may be performed by a combination of assumptions, measurements and calculations. Residency times can either be assumed or measured for each patient. If residency times for a particular patient are assumed, the assumed values must be backed by measured average data of a population of patients. The assumed residency times and the measured dose rate at 1 meter from the patient shall be used in the equations provided by NUREG 1556 to determine the TEDE. If not data exist to make the necessary assumptions and calculations of TEDE using NUREG 1556, the release shall be based on measured exposure rates at 1 meter as indicated in Table U.1 and Table U.2. of NUREG 1556.

-27-

D.1.e Release of any Betta-emmiting patients P-32, Sr-89, Y-90

Based on NUREG 1556 tables U.1 and U.2 there are no limits regarding the release of these patients and or providing instructions to these patients. Hence, patients administered this radipharmaceuticals will be released immediately. Instructions to keep doses to the general public ALARA should be provided but are not required. No documentation of patient release and or instructions provided is necessary.

Sm-153

Because of the relatively large gamma photon component of the decay of this isotope, the limits of this mostly beta emitting isotope are stipulated at different levels from those stipulated above. Patients administered less than 700 mCi or the dose rate is less than 30 mr/hr patients will be immediately released. No documentation is necessary to demonstrate compliance. There is not need to provide written instructions, on how to maintain doses ALARA, to the patients.

D.2 Administration Procedures D.2.a Administration Areas

Unless otherwise stated by radiopharmaceutical specific administration procedures, administration of isotopes shall be performed on the Siteman Cancer Center, Radiation Oncology Department, Vault 1. If this area is not available, patient evaluation room 16 on the same floor level shall be used. Before administration is performed, the area must be properly prepared to minimize the spread of contamination in the event of a spill. The area shall not be released for general public/patient use until a radiation safety survey and contamination survey indicate background levels exist.

D.2.b Source Administration Personnel

Depending on the radiopharmaceutical isotope, form and administration route, the administration of the radiopharmaceutical shall be performed by either 1) an authorized user as stipulated by the radiation safety committee 2) by a physician that meets training requirements and is under direct supervision of an authorized user or 3) by a trained brachytherapy technologist. For complex administration procedures within the department and for administration procedures occurring outside the department, the Authorized User and a trained brachytherapy technologist (RTT) shall be present during the administration. The authorized medical physicist should be present during the administrations but is not required.

D.2.b General Radiopharmaceutical Handling and Injection/Administration Procedures

Unless otherwise stated by radiopharmaceutical specific administration procedures, administration of isotopes shall be performed following the guidelines stipulated on the “General Radiopharmaceutical Handling Injection and Administration Procedures”.

D.2.c I-131 NaI (Sodium Iodine Oral Solution) – Out Patient Administration Setting

-28-

Patients receiving I-131 doses exceeding 33 mCi maybe released immediately as outpatients provided that an I-131 patient a release worksheet is filled out demonstrating that for the proposed prescribed administration, the TEDE at 1 m is less than 500 mSv and that patients receive written instructions on how to maintain doses to others as low as reasonable achievable.

Outpatient I-131 NaI administrations should be only performed in the Needle Prep Room in Brachytherapy Suite, CAM building. The surrounding floor as well as patient's chair and treatment table covered with absorbent paper. After releasing the patient, the administration area shall be surveyed for radiation levels. On a weekly basis several areas 10x10 cm2 areas shall be wipe tested. If the survey indicates radiation levels above background or the wipes reveal more than 200 dpm/100 cm2, the absorbing paper should be disposed of as radioactive waste, the area decontaminated, and repeat wipe tests and surveys performed. The "wipes" may be read out in the Capintec CAPRAC scintillation-detector well chamber or sent to the Radiation Safety Office for evaluation. To minimize the possibility of contamination, the rubber gloves worn by persons in contact with I-131 containers, vials, etc., shall not be brought into contact with items outside the work area.

D.2.d I-131 NaI (Sodium Iodine Oral Solution)-In Patient Setting

I-131 NaI patients maybe treated as inpatients per our usual policy. In this setting, no member of the general public shall receive more than 1 mSv (100 mR). Both 10 CFR 35 and NUREG 1556 specify that a private room with private sanitary facilities must be supplied to all inpatients receiving I-131 in excess of 33 mCi or have exposure rates at 1 in exceeding 7 mR/h.

The I-131 shall be administered to the patient in his or her room. The brachytherapy technologist,

rather than the radiation oncology physician should administer I-131 radiopharmaceutical doses whenever possible. The intent of this policy is to minimize the number of individuals who must have I-131 thyroid scans as required by our NRC license. Whenever possible, only the brachytherapy technologist or physicist should handle the open vial of I-131. All other individuals in the room, including the supervising physician, should remain at a distance of at least 2 in from the vial from the time it is opened until completion of the administration. Anyone within 2 m of the open vial must have a follow-up thyroid scan within 72 hours. Should the thyroid scan of any tested individual indicate an uptake greater than 40 nCi, everyone present must be scanned.

The room shall be properly prepared prior to administration of the radiopharmaceutical. The

room shall be posted in accordance with requirements set down in 10 CFR 35. Except for emergencies, the patient shall remain in the room until discharged.

I-131 patients maybe released from medical confinement when the exposure rate at 1 m falls below 7 mR/h or the decayed administered activity falls below 33 mCi. In the former case, a record of the basis of release must be retained. Written ALARA instructions must be provided to release patients.

D.2.e Beta emitting isotopes

Patients receiving Sr-89 (typically 4 mCi) , Sm-153 (1 mCi/kg patient weight), P-32 (typically less than 15 mCi), Y-90 (Zevalin, less than 32 mCi or Sirtex, less than 3 GBq) need not be confined after treatment has been administered, need not be given written ALARA instructions, and do not require maintaining a written record documenting the basis of release. According to NRC regulations, those who do remain in the hospital need not be assigned private rooms. With the exception of Sirtex Y-90, all other radiopharmaceutical administrations shall be performed in a room designated by Radiation Oncology Brachytherapy Center and approved by

-29-

the Radiation Safety office. As of the writing of this manual, the main administration room is Vault 1 of the siteman cancer center, radiation oncology department. Sirtex Y-90 administrations shall be performed on the 3rth floor, Interventional Radiology Suite. Specific procedures have been written for this administration and shall be followed. In general, the room to be used shall be prepared to minimize the spread of contamination in the event of a spill by the IR suite personal prior to performing the administration. The source shall be prepared on the source room of the SCC/LL brachtherapy center and shall be carried by brachytherapy personnel to the IR suite. The setup of the administration apartus shall be performdd by the interventioal radiologist and verified by the brachytherapy center personell( RTT/Authorized user and physics staff). The authorized user and brachytherapy center technologist must be present during the administration. The physics staff personnel should be present during the administration. The room must be inspected for contamination prior to releasing it for general use. The procedures as stipulated on the “General Radiopharmaceutical Handling Injection and Administration Procedures” shall be followed. In addition, depending on the radiopharmaceutical being administered, administration specific procedures should be available, shall be followed and shall supersede those on the “General radiopharmaceutical handling and injection procedures”. After radiopharmaceuticals have been administered, emptys vials, syringes and any IV lines that may have come in contact with the radiopharmaceutical shall be deposited inside a zip lock bag and such bag deposited within in the dry waste canister in the Source room SCC LL. All syringes shall be shall be capped and returned to the metal case in which they were shipped to the hospital.

E. Nursing QA in Caring for Radiopharmaceutical Patients

Consistent with their patient-care responsibilities, nurses shall reduce their exposure to radiation emitted from the patient by reducing their time with the patient, increasing their average distance from the patient while in the room and standing behind the lead shields near the patient's bed whenever possible. In addition, nurses (and other personnel entering the room) shall wear shoe covers, gloves and other protective clothing that their involvement with the patient suggests are needed. Before exiting the room, nurses and other personnel shall place such clothing in plastic bags for biohazards (disposable waste and linen), located inside the room. Except in case of medical emergency, patients receiving radiopharmaceutical therapy shall not be permitted to leave the room until after the patient has been surveyed by a Radiation Oncology brachytherapy technologist, physicist, or Radiation Safety Office Personnel, and it has been determined that the exposure rate from the patient is acceptable for release of the patient based on NUREG 1556 guidelines to comply with 10CFR35.75. After the patient has been discharged, the door to the room shall be locked. Housekeeping shall not be admitted to the room until the room has been de-contaminated and released by the Radiation Safety Office. For each of the radiopharmaceutical administrations there shall be specific nursing procedures prepared as necessary. This procedures shall supersede any general procedures as indicated in this manual. Training of nurses on the safety aspects of handling radiopharmaceutical patients should be performed once a year.

F. Radiopharmaceutical Quality Assurance Check-Off List

-30-

Quality Assurance Check-Off List shall be filled out for each patient receiving radiopharmaceutical therapy, and placed in the patient's chart. The checklist shall contain pertinent information on pre-treatment status of the patient, treatment preparation and execution, patient discharge and post-treatment documentation and audit. In addition, depending on the radiopharmaceutical being administered, specific administration QA check off list should be available and shall be utilized.

VI. PERMANENT IMPLANT PROSTATE BRACHYTHERAPY QUALITY ASSURANCE

Like the HDR and LDR QA protocols, this protocol focuses on the following physical accuracy endpoints: 1. Positional Accuracy: A positional accuracy criterion of 2 mm should be utilized and is known to be

achievable in the following domains: alignment of implant template with ultrasound machine screen grid, spacing of the sources in needles. Accuracy of needle positioning relative to patient anatomy and to pre implant plan can not be easily quantified and varies with individual patients and needles from 1-10 mm. Ultrasound images, fluoroscopic images, reference markers, and physical measurements should be used for guidance in needle placement. At the beginning of each implant day, alignment of implant template with ultrasound machine screen grid shall be verified. For each implant, source arrangement in needles shall be verified against the treatment plan using a needle autoradiograph. Alignment of the ultrasound images grid with the computer treatment planning system template should be within 0.5 mm.

2. Source Strength Accuracy: Prior to clinical use, supplied vendor source strength values shall be

empirically verified against NIST-traceable sealed-source air-kerma strength calibration standards. At least 10% of sources shall be surveyed. Each institution shall acquire NIST or ADCL calibrations for each type of source or isotope clinically used. Calibration of a clinical source shall consist of intercomparing it with the corresponding source standard in an instrument (usually a re-entrant ion chamber) the response of which is proportional to air-kerma strength of the given source. Since I-125 interstitial sources are short lived, the constancy of the intercomparison instrument must be monitored using a long-lived source such as Cs-137. The physicist shall transfer the NIST calibration from the source standard to clinical sources of the same type with an accuracy of 2%. Tolerances for accepting the vendor calibration are 3% when averaged over a group of nominally identical sources and 5% for individual sources. It is the physicist's responsibility to resolve discrepancies of 5% or more between vendor and institutional calibrations.

3. Treatment Time Accuracy: Does not apply to permanent implants. 4. Radiation Safety: Exposures to the general public and employees must adhere to the limits set forth in

10 CFR part 20. Other requirements pertaining to posting, training, documentation, source inventory, instrument calibration, etc. must adhere to 10 CFR part 35 requirements and individual license commitments. Exposure level at 1 m from every patient shall be measured prior to patient release and recorded on the Patient Survey form (Prostate Implant Forms Appendix). Following the implant, a complete survey of operating room and supplies used for the procedure shall be performed. Permanent implant patients may be released from confinement with no restrictions if the total dose equivalent to any other individual is not likely to exceed 500 mR. This determination will be made by measuring the exposure rate at 1 m using a calibrated ion chamber survey meter. Per 10 CFR 35.75(c), the basis of release must be documented. If the dose equivalent to any individual is likely to exceed 100 mR, the patient must be provided with oral and written instructions.

5. Dose Calculation Accuracy: Dose computation programs used in computer-assisted treatment

planning should have an accuracy of 2%. This is interpreted to mean, that given known input values (AAPM TG43 type dosimetry data), doses calculated by the program should agree within 2% with independent values obtained by manual calculations, the published literature, or an independent computer program. For single sources, doses on the transverse axis at distances less than 5 mm may have errors of 3%. Deviations from these accuracy limits shall be discussed with the Chief of Brachytherapy Physics and the responsible radiation oncologist.

-31-

A. Commissioning and Acceptance Testing

1. Sources a. Before initiating clinical use of new sources model, the following shall be performed: i) Appropriate published dosimetry data for the source shall be reviewed and any

differences from previously used source model identified ii) All differences shall be reviewed with the implant physician and possible clinical

consequences shall be evaluated. iii) Vendor calibrations shall be verified according to the guidelines described above, which

implies that the NIST traceable calibration source should be obtained. b. Sources shall be logged into the permanent inventory records with signatures.

c. Appropriate data (AAPM TG43 type dosimetry data) consistent with recommendations of the current literature must be entered into the RTP system to facilitate computer-assisted dose calculation. The results must be verified using point-dose estimates (not isodose curve position) against independent calculations or published dosimetry data. Requirements of the algorithm, dimensions and composition of source components, expected clinical utilization and national protocol requirements (e.g. RTOG) must be taken into account in generating 3D single-source dose matrices and dose volume histograms.

d. Source Strength Calibration Device i. Source positioning jigs should be constructed to eliminate significant (> 1 %) variations in

instrument response due to positioning variations. ii. Precision of repeated readings shall be verified. Generally, the range of readings when

repeated with the same source should be no more than ±1 %. Drift of instrument response with time must be measured. If its response varies by more than 1% from session-to-session, each reading should be normalized to the expected response from a long-lived source of known strength.

iii. Linearity (or ion recombination corrections) shall be verified over the entire source-strength

range that the physicist expects to encounter in clinical practice. The leakage should be measured and if necessary, subtracted from each reading. For a fixed position in the calibrator and type of source, the response of the instrument should be linear within 2%.

iv. The instrument response/unit air-kerma strength for each source type used clinically must be

measured. These factors are obtained by placing sources, that have been calibrated in terms of air-kerma strength by an ADCL or NIST, in the calibration position and noting the reading. These measurements should be repeated several times over a 2-4 week period to assess precision of the calibration transfer. Ideally one scale (mCi) should be used for all isotopes with varying correction factors. A procedure for easily verifying instrument response using a long-lived source of known strength must be developed.

v. NIST-traceable calibration shall be obtained every 2 years. This interval can be lengthened to

four years if the calibration is verified relative to an instrument (RPC or another ROC affiliate) having a more current calibration.


-32-

Prior to clinical implementation, recently acquired or updated computer treatment planning systems shall be subjected to the appropriate subset of accuracy/function tests listed in the table:



Initially, annually



Initially, annually



Initially, annually New software version or source changes

Accuracy of single-source Isodoses





Consistency of printed plan documentation

Assumed input parameters Every clinical use

Accuracy of co-ordinate reconstruction

CT phantom with known catheter geometry


Dose volume histogram Use phantom of known dimensions


Optimization software Run series of test cases based upon idealized implant geometries of various sizes. Develop a sense of what optimization does to an implant compared to uniform loading before trying it on patients

Initially. Spot check when software changes by duplicating old cases



A report on implementation/commissioning of a new treatment planning system, software version, source model or type shall be submitted to Director of Physics. The report should include results and supporting data for all tests, procedures and forms, relevant references, and should identify any possible changes in clinical practice.

B. Annual Review(s)

The responsible brachytherapy physicist shall perform an annual QA review which shall include the tests outlined below. The form of the report shall consist of a brief summary describing the test outcomes, acquisition of any new reviewable equipment, any deviations from stated QA criteria and any corrective actions. Each test (accept calibrator QA) should be documented on the appropriate form which should be appended to the report and shall be submitted to the Physics Chief for review.

1. Calibration Instrumentation Review of calibration instrumentation, should be performed as a part of general

brachytherapy annual quality assurance. 2. Treatment Planning System

-33-

Computer point-dose calculations shall be compared to manual or independent computer calculations (stating technique or reference). Input data should be verified, followed by comparison of doses at several points. For example, points transverse to the source should be compared from 5 mm to 50 mm with no difference >3%. Standard benchmark implant plans should be run and checked for accuracy. Geometric accuracy of peripheral 1/0 devices should be checked.

3. Ultrasound Machine The functionality, accuracy, and image quality of the ultrasound machine shall be evaluated

on monthly basis (Prostate Implant Forms Appendix). Tests should be based on the alignment calibration phantom and Nuclear Associates ultrasound imaging quality assurance phantom.

4. Fluoroscopic C-arm The annual quality assurance for the C-arm is performed as a part of the general

brachytherapy quality assurance. The review evaluates positional accuracy of the device as well as imaging performance.

C. Treatment-Specific QA and Procedures


a. Volume study and the written directive At least ten days prior to implant, an ultrasound volume study of the prostate should be

performed. During the study, transverse images of the prostate, spaced 5 mm apart, shall be recorded on the VHS tape and/or CD and also printed using the ultrasound machine heat transfer printer. The scans should include patient name and ID number. The entire prostate should be contoured and the image containing information about the total prostate volume recorded.

An attending physician should evaluate the patient for possible pubic arch interference. The physician shall relay to dosimetry or physics the target volume dose, isotope, source

strength, and any other special problems and consideration. A written prescription should be prepared early in the treatment planning process.

b. Treatment plan Correct patient name and ID number shall be verified when importing volume study images

into the treatment-planning computer. Brachytherapy physicist prior to ordering implant sources shall review all treatment plans. The treatment plan review shall include verification of: patient name and ID number, prescription dose, source type, source model, source strength, template alignment, image plane spacing, target volume compared to ultrasound machine calculation, target coverage (by reviewing both the dose volume histogram and individual isodose lines throughout the target volume), simplicity and technical practicality of the plan, BASE plane position, and location of individual sources and needles. The physicist shall verify that the treatment plan is in agreement with the written directive. All deviations from the written directive, possible problems, and concerns shall be discussed with the radiation oncologist.

Prior to the implant procedure (preferably prior to ordering sources) the physician shall

review the plan for clinical adequacy, accuracy, and technical practicality.

-34-

c. Source ordering and calibration

To order interstitial sources, an Isotope Request Form (Appendix IV) shall be completed by the attending physician or physicist, the sources ordered by the physicist, and the form faxed to the Radiation Safety Office so they are prepared to receive the radioactive source shipment.

A physicist shall check in all isotope shipments. Vendor documentation must agree as to

isotope, form, and strength of the isotope with the order form. Source must have been leak tested with last 6 months. Package must have been surveyed by Radiation Safety and the outer container wipe tested.

Verification of vendor calibration against NIST standards of at least 10% of the shipment

shall be performed. The number of sources or ribbons must be counted. The Source Receipt Form, an integral part of the ROC inventory system, should be used.

Paperwork documenting vendor calibration, receipt, leak tests, and number of sources should be appended to Source Receipt Form. In the event of procedure cancellation, the manufacturer shall be contacted by a physicist, as soon as possible, and arrangements for order cancellation shall be made.

d. Needle preparation

The needle loading diagram shall be prepared by a physicist or a dosimetrist and relayed to a person responsible for loading the needles. A physicist shall verify the needle loading patterns from needle autoradiograph and placing of the needles into to needle box. At this time a count of remaining sources shall be performed. I don’t think we always have the physicist do this…

2. Implant

At the day of the implant or 24 hours within time of implant??, a physicist shall perform ultrasound machine quality assurance as outlined above. Prior to the procedure all patients shall be identified in accordance with the ROC QMP program. During the implant, there shall be a redundant method for verification of needle placements. All modifications to the written directive shall be documented prior to completion of the procedure and signed by the attending physician. Following the implant, the patient, operating room, and supplies (including trash) shall be surveyed as described above. The final source count shall be performed at this time. All sources (implanted in the patient, extra sources implanted, sources removed through cystoscopy, and sources loaned to other patients) shall be counted.

3. Post-Implant plan

All post-implant plans shall be reviewed by a physicist. The review shall include verification of: patient name and ID number, prescription dose, source type, source model, source strength, image plane spacing, target volume compared to pre-implant plan volume, target coverage (by reviewing both the dose volume histogram and individual isodose lines throughout the target volume), accuracy of source identification on CT images, and number of identified sources. The physicist shall verify that the treatment plan is in agreement with the written directive. All deviations from the written directive, possible problems, and concerns shall be discussed with the radiation oncologist. The radiation oncologist shall review the plan for clinical adequacy, accuracy.

-35-

VII. PERMANENT IMPLANT LUNG BRACHYTHERAPY QUALITY ASSURANCE

B. General Aspects of Permanent Lung Brachytherapy Quality Assurance

Permanent lung brachytherapy implant uses low energy interstitial sources sutured to the surgical margins of lung cancer patients. Typically the sources, embedded in absorbable suture, are sutured at preplanned distances from the surgical margin, as identified by the surgical clips/staples. This protocol focuses on the following physical accuracy endpoints:

1. Positional Accuracy: The sources should be sutured as specified in the treatment protocols. A sterile

ruler should be used to measure the distances to the surgical margins. The measured distances may be marked with a surgical pen. The sources should be sutured to within 2 mm of the marked distances.


empirically verified against NIST-traceable sealed-source air-kerma strength calibration standards. For sources in suture lines, an additional source from the same batch should be ordered for the source strength measurement. Each institution shall acquire NIST or ADCL calibrations for each type of source or isotope clinically used. Calibration of a clinical source shall consist of intercomparing it with the corresponding source standard in an instrument (usually a re-entrant ion chamber) the response of which is proportional to air-kerma strength of the given source. Since Pd-103 and 1-125 interstitial sources are short lived, the constancy of the intercomparison instrument must be monitored using a long-lived source such as Cs-137. The physicist shall transfer the NIST calibration from the source standard to clinical sources of the same type with an accuracy of 2%. Tolerances for accepting the vendor calibration are 3% when averaged over a group of nominally identical sources and 5% for individual sources. It is the physicist's responsibility to resolve discrepancies of 5% or more between vendor and institutional calibrations.

3. Temporal Accuracy: Does not apply to permanent implants. 4. Radiation Safety: Exposures to the general public and employees must adhere to the limits set fourth

in 10 CFR part 20. Other requirements pertaining to posting, training, documentation, source inventory, instrument calibration, etc. must adhere to 10 CFR part 35 requirements and individual license commitments. Exposure level at 1 m from every patient shall be measured prior to patient release and record on the Patient Survey form (Permanent Implant Forms Appendix). Following the implant, a complete survey of operating room and supplies used for the procedure shall be performed. Permanent implant patients may be released from confinement with no restrictions if the total dose equivalent to any other individual is not likely to exceed 500 mR. This determination will be made by measuring the exposure rate at 1 m using a calibrated ion chamber survey meter. Per 10 CFR 35.75(c), the basis of release must be documented. If the dose equivalent to any individual is likely to exceed 100 mR, the patient must be provided with oral and written instructions.

As the patient will be admitted in the hospital for a period of time, radiation safety training will be

provided to the floor nursing staff. The patient will be housed in a private room during his/her hospital stay. The doors to the patient room will be posted with Nursing Procedure, Instructions to Nurses, Radiation Warning Sign, as well as a Room Survey Form. Following the patient’s discharge from hospital, Radiation Oncology staff will perform a room survey before returning the patient’s room to routine clinical use.



-36-

B. Commissioning and Acceptance Testing











iv. The instrument response/unit air-kerma, strength for each source type used clinically must be






-37-

Function Benchmark Data Frequency

Verify geometric accuracy of I/O peripherals: digitizer, CT or ultrasound interface, and plotter


Initially, annually



Initially, annually



















C. Annual Review(s)

The responsible brachytherapy physicist shall perform an annual QA review which shall include the tests outlined below. The form of the report shall consist of a brief summary describing the test outcomes, acquisition of any new reviewable equipment, any deviations from stated QA criteria and any corrective actions. Each test (accept calibrator QA) should be documented on the appropriate form which should be appended to the report and shall be submitted to the Physics Chief for review.


brachytherapy annual quality assurance. 2. Treatment Planning System Computer point-dose calculations shall be compared to manual or independent computer

calculations (stating technique or reference). Input data should be verified, followed by comparison of doses at several points. For example, points transverse to the source should be compared from 5 mm to 50 mm with no difference >3%. Standard benchmark implant plans should be run and checked for accuracy. Geometric accuracy of peripheral 1/0 devices should be checked.

D. Treatment-Specific QA and Procedures


-38-

a. The written directive A written prescription is required for this treatment and should be prepared early in the

treatment planning process. An authorized user shall sign and date the written prescription before the treatment starts.

b. Treatment plan Brachytherapy physicist prior to ordering implant sources shall review all treatment plans.

The treatment plan review shall include verification of: patient name and ID number, prescription dose, source type, source model, source strength. The physicist shall verify that the treatment plan is in agreement with the written directive. All deviations from the written directive, possible problems, and concerns shall be discussed with the radiation oncologist.

Prior to the implant procedure (preferably prior to ordering sources) the physician shall

review the plan for clinical adequacy, accuracy, and technical practicality. c. Source ordering and calibration


A physicist shall check in all isotope shipments. Vendor documentation must agree as to

isotope, form, and strength of the isotope with the order form. Source must have been leak tested with last 6 months. Package must have been surveyed by Radiation Safety and the outer container wipe tested.




2. Implant

An authorized user shall be present in the operating room to supervise the placement of brachytherapy sources. Prior to the procedure all patients shall be identified in accordance with the ROC QMP program. All modifications to the written directive shall be documented prior to completion of the procedure and signed by the authorized user. Following the implant, the patient, operating room, and supplies (including trash) shall be surveyed. The final source count shall be performed at this time. All sources (implanted in the patient, extra sources implanted, and sources loaned to other patients) shall be counted.

3. Post-Implant plan

-39-

All post-implant plans shall be reviewed by a physicist. The review should include verification of: patient name and ID number, prescription dose, source type, source model, source strength, image plane spacing, target volume compared to pre-implant plan volume if applicable, target coverage (by reviewing both the dose volume histogram and individual isodose lines throughout the target volume), accuracy of source identification on CT images, and number of identified sources. The physicist shall verify that the treatment plan is in agreement with the written directive. All deviations from the written directive, possible problems, and concerns shall be discussed with the radiation oncologist. The radiation oncologist shall review the plan for clinical adequacy, accuracy.

VIII. TEMPORARY EYE PLAQUE BRACHYTHERAPY QUALITY ASSURANCE

A. General Aspects of Temporary Eye Plaque Brachytherapy Quality Assurance

Temporary eye plaque implant uses low energy interstitial sources placed in a gold seed carrier which is then sutured to the surface of the eye of patients with ocular melanoma. The seed carriers, or plaques, can vary in size from 12 mm to 22 mm depending on the size of the tumor and can also come in a notched form to allow for placement of the plaque against the optic nerve in the case where the tumor abuts the nerve. The prescription dose depends on the tumor dimensions as well as proximity of the tumor to normal structures, like the optic nerve and macula. This protocol focuses on the following physical accuracy endpoints:

1. Positional Accuracy: The sources should be positioned in the eye plaque as specified by the

Collaroborative Ocular Melanoma Study (COMS protocol). Placement of the eye plaque is verified in the operating room with ultrasound.


empirically verified against NIST-traceable sealed-source air-kerma strength calibration standards. Because typically anywhere from 13-21 sources are ordered per implant, a deviation in source strength in a single source can lead to a significant change in the dose distribution. Thus, it is important to verify the source strength of each and every source to be implanted in the patient. Each institution shall acquire NIST or ADCL calibrations for each type of source or isotope clinically used. Calibration of a clinical source shall consist of intercomparing it with the corresponding source standard in an instrument (usually a re-entrant ion chamber) the response of which is proportional to air-kerma strength of the given source. Since I-125 interstitial sources are short lived, the constancy of the intercomparison instrument must be monitored using a long-lived source such as Cs-137. The physicist shall transfer the NIST calibration from the source standard to clinical sources of the same type with an accuracy of 2%. Tolerances for accepting the vendor calibration are 3% when averaged over a group of nominally identical sources and 5% for individual sources. It is the physicist's responsibility to resolve discrepancies of 5% or more between vendor and institutional calibrations.

3. Temporal Accuracy: Typically, treatment times for temporary eye plaque implants are either 96 hours

or 120 hours. At the time of implant, the actual time of insertion and the expected time of removal of the eye plaque implant will be documented on the prescription form and Patient Radiation Survey form.

At the time of source removal the Radiation therapy technologist will be in charge of quantifying the

exact amount of time the sources where in place and compare this against the prescribed amount of time. If deviations of more than 3 hrs (~5%) occur, the RTT shall communiqué this to the physics staff to take proper measures.

4. Radiation Safety: Exposures to the general public and employees must adhere to the limits set forth in

10 CFR part 20. Other requirements pertaining to posting, training, documentation, source inventory, instrument calibration, etc. must adhere to 10 CFR part 35 requirements and individual license

-40-

commitments. Physics staff member will direct placement of lead shield over patient’s eye to minimize exposure around patient. Exposure level at surface of lead shield and at 1 meter away from every patient shall be measured prior to patient transport from the operating room. A survey of operating room shall be performed once patient has been transported from the room. These measurements shall be documented on the prescription and Patient Survey form. A wristband with identifying the patient as a radioactive patient will be attached to patient’s wrist before removal from operating room. In addition, a copy of the prescription form shall be attached to the patients medical chart.

While the radioactive eye plaque is in the patient, the patient will be hospitalized to maintain

possession of the seeds. Radiation safety training will be provided to the floor nursing staff. Patient to be kept in a private room, or can share a room with another eye plaque patient. The doors to the patient room will be posted with Nursing Procedure, Instructions to Nurses, Radiation Warning Sign, as well as a Room Survey Form.

Upon removal, a brachytherapy technologist, shall verify the number of seeds in the plaque, collect the

plaque, performs source removal survey, and return the eye plaque to the CAM Source room where the plaque insert will be entirely removed from plaque and kept in storage for decay and disposal at a later time. The RTT shall log on the source disposal log the time the sources where returned to the source room.

On a need to do basis, the physics staff shall perform and inventory and disposal/transfer of the

sources kept in storage in the Source Room to the radiation safety office. The radiation safety office will be in charge of final disposal of the sources.



A. Commissioning and Acceptance Testing






-41-






iv. The instrument response/unit air-kerma, strength for each source type used clinically must be




B. Computer-Assisted Treatment Planning Systems




Initially, annually



Initially, annually
















Overall system test Run series of standardized plans to globally test all


-42-

clinically-used features Annually


C. Annual Review(s)

The responsible brachytherapy physicist shall perform an annual QA review which shall include the tests outlined below. The form of the report shall consist of a brief summary describing the test outcomes, acquisition of any new reviewable equipment, any deviations from stated QA criteria and any corrective actions. Each test (except calibrator QA) should be documented on the appropriate form which should be appended to the report and shall be submitted to the Physics Chief for review.


brachytherapy annual quality assurance. 2. Treatment Planning System Computer point-dose calculations shall be compared to manual or independent computer

calculations (stating technique or reference). Input data should be verified, followed by comparison of doses at several points. For example, points transverse to the source should be compared from 5 mm to 50 mm with no difference >3%. Standard benchmark implant plans should be run and checked for accuracy. Geometric accuracy of peripheral I/0 devices should be checked.

D. Treatment-Specific QA and Procedures


a. The written directive A written prescription is required for this treatment and should be prepared early in the

treatment planning process. An authorized user shall sign and date the written prescription before the treatment starts.

b. Treatment plan Ophthalmologist will provide information necessary for treatment planning to physics staff,

e.g., tumor dimensions, apex height, plaque size, etc. Physics staff member shall, based on this information, determine source strength. Authorized user shall review the information provided by ophthalmologist.

Prior to implant procedure brachytherapy physicist shall review all treatment plans. The

treatment plan review shall include verification of: patient name and ID number, prescription dose, source type, source model, source strength. The physicist shall verify that the treatment plan is in agreement with the written directive. All deviations from the written directive, possible problems, and concerns shall be discussed with the radiation oncologist.

Prior to the implant the physician shall review the plan for clinical adequacy, accuracy, and

technical practicality.

-43-

c. Source ordering and calibration


A physics staff member shall check in all isotope shipments. Vendor documentation must

agree as to isotope, form, and strength of the isotope with the order form. Source must have been leak tested with last 6 months. Package must have been surveyed by Radiation Safety and the outer container wipe tested.




2. Implant

a. Operating Room A physics staff member and, if possible, authorized user shall be present in the operating room for plaque insertion. Prior to the procedure all patients shall be identified in accordance with the ROC QMP program. All modifications to the written directive shall be documented prior to completion of the procedure and signed by the authorized user. Prior to implant, the integrity of the eye plaque shall be verified. The number of seeds in the plaque shall be verified. Time of implant of eye plaque shall be recorded on prescription and survey and inventory forms. Following the implant, the patient, operating room, and supplies (including trash) shall be surveyed. Lead shield placed over patient’s eye. Results of survey will be documented on survey and inventory forms.

b. Hospital Stay Patient is to be kept hospitalized during entire implant time. Patient to be kept in a separate

room, or can share a room with another eye plaque patient. Patient to keep lead shield over eye at all times. The doors to the patient room will be posted with Nursing Procedure, Instructions to Nurses, Radiation Warning Sign, as well as a Room Survey Form. Visits by pregnant women or by those under age of 18 should be less than 30 minutes. What are our instructions?

c. Implant Removal Removal of eye plaque implant is done in the operating room by the ophthalmologist

Following removal, the integrity of the eye plaque shall be verified. The number of seeds in the plaque shall be verified. Time of removal of eye plaque shall be recorded on prescription and survey forms and inventory forms. The patient and area shall be surveyed.

-44-

The eye plaque will be returned to the CAM Source room where the plaque insert will be entirely removed from plaque and kept in storage for decay and disposal at a later time. Brachytherapy technologist completes all documentation for patient. What is that???? Results of survey will be documented on survey and inventory forms.—are there separate forms???

IX. LOW DOSE RATE BRACHYTHERAPY QUALITY ASSURANCE Although most of the LDR procedures involving the use of Cs -137 tubes and Low dose Rate Remote Afterloaders have been discontinued at our institution as of this date, the use of Ir-192 Low Dose Rate brachytherapy sources may still be a possibility. For this reason, and for educational purposes ,sections of this manual relating to the use of LDR Ir-192 are still applicable and will be followed. A. General Aspects of LDR QA

1. Positional Accuracy: A positional accuracy criterion of 1 mm should be utilized and is known to be achievable in the following domains: external and internal mechanical dimensions of all sources and applicators, seed spacing, and positioning of radioactive and dummy sources in applicators. As with HDR, accuracy of applicator positioning relative to patient anatomy cannot be easily quantified and varies with the type of procedure from 1-10 mm. Source coordinates and interest points should be digitized during treatment planning with an accuracy of better than 1.5 mm allowing implants to be spatially reconstructed with a relative geometric error of 2 mm. Tests include transmission- and autoradiography as well as direct measurement with calipers. Remote afterloading equipment should be capable of positioning sources within 1 mm of the programmed position and shall have an accuracy of 2 mm.

2. Accuracy of Source Strength: Prior to clinical use, each institution shall empirically verify the

vendor-supplied source strength values against NIST-traceable sealed-source air-kerma strength calibration standards. Each institution shall acquire NIST or ADCL calibrations for each type of source or isotope clinically used. Calibration of a clinical source shall consist of intercomparing it with the corresponding source standard in an instrument (usually a re-entrant ion chamber) the response of which is proportional to air-kerma strength of the given source. Since Ir-192 and 1-125 interstitial sources are short lived, the constancy of the intercomparison instrument must be monitored using a long-lived source such as Cs-137. The physicist shall transfer the NIST calibration from the source standard to clinical sources of the same type with an accuracy of 2%. Tolerances for accepting the vendor calibration are 3% when averaged over a group of nominally identical sources and 5% for individual sources. It is the physicist's responsibility to resolve discrepancies of 5% or more between vendor and institutional calibrations.

3. Treatment Time Accuracy: For remote afterloading devices, timer accuracy criterion of 2% should

govern all quality assurance activities. Manual and computerized treatment-time calculations should have an accuracy of 3%. Treatment delivery times for manually-afterloaded implants should be delivered with an accuracy of 5%.

4. Radiation Safety: Exposures to the general public and employees must adhere to the limits set fourth

in 10 CFR part 20 and WUSM Radiation Safety Manual. Other requirements pertaining to posting, training, documentation, source inventory, instrument calibration, etc. must adhere to 10 CFR part 35 requirements and individual license commitments.


planning as well as other dosimetry aids such as surface-dose tables should have an accuracy of 2%. This is interpreted to mean, that given known input values (buildup factors, active length, etc.), doses calculated by the program should agree within 2% with independent values obtained by manual calculations, the published literature, or an independent computer program. For single sources, doses on the transverse axis at distances less than 5 mm may have errors of 3% and filtered-source dose

-45-

calculation programs should be accurate within 10% near the longitudinal axis. Deviations from these accuracy limits shall be discussed with the Chief of Brachytherapy Physics and the responsible radiation oncologist.


1. Intracavitary Sources a. Before initiating clinical use of new sources, the following shall be verified: i) Individual serial numbers, adequacy of leak test documentation, and consistency of

color-coding if present ii) Internal and external dimensions, mechanical integrity, uniformity of radioactivity

distribution, and density (qualitatively) of internal components against mechanical drawings supplied by the vendor. Each source shall be autoradiographed using Kodak-TL or V film upon which a diagnostic-quality x-ray is superimposed without moving the source.

iii) Vendor calibrations shall be verified according to the guidelines described above. V) Mechanical and geometric compatibility of sources with applicators and simulation

dummies vi) Remotely afterloaded Cs-137 source calibrations must be checked annually against a

NIST-traceable standard per our NRC license. b. Sources shall be logged into the permanent inventory records with signatures. c. Appropriate data (dimensions, attenuation and buildup factors, effective attenuation

coefficients, anisotropy factors, etc.) consistent with recommendations of the current literature must be entered into the RTP system to facilitate computer-assisted dose calculation. The results must be verified using point-dose estimates (not isodose curve position) against independent calculations or published dosimetry data. Requirements of the algorithm, dimensions and composition of source components, expected clinical utilization and national protocol requirements (e.g. COMS) must be taken into account in generating 1-D and 2-D single-source dose matrices.

2. Applicators a. All external and internal dimensions, including shape, thickness and position of any shielding

shall be checked against the vendor's mechanical drawings. The accuracy of active source positioning must be verified within 1 mm. Orthogonal megavoltage or simulation radiography with dummy sources in place is the accepted test procedure. If symmetric positioning of the active source with the applicator boundaries visible on simulation radiographs is not possible, templates must be constructed to facilitate accuracy localization of sources for treatment planning.

b. Correct mechanical function to be checked before each use. c. For new combinations of shielded applicators and sources, some attempt to assess dosimetric

compatibility of the new source-applicator combination with that assumed by the clinicians' base of clinical experience should be made. For shielded applicators, this involves estimating the location, geometric shape and degree of dose reduction produced by internal shielding components. For surface applicators, surface-dose uniformity and depth dose are important. Available dosimetric tools include standard superposition calculations, geometric shielding analysis, film dosimetry, TLD dosimetry and Monte Carlo simulation.

d. Templates for interstitial therapy must be verified for spacing, operation and integrity.

-46-

e. Compatibility of institutional sterilization procedures with vendor recommendations must be checked.

3. Dummy Sources

a. Cesium dummy sources shall be checked for correct active and physical lengths. b. Iridium dummy sources shall be checked for length and spacing. c. Iodine dummy sources shall be checked radiographically for opaque markers.

4. Source Strength Calibration Device a. Source positioning jigs should be constructed to eliminate significant (> 1 %) variations in

instrument response due to positioning variations. b. Precision of repeated readings shall be verified. Generally, the range of readings when


c. Linearity (or ion recombination corrections) shall be verified over the entire source-strength

range the physicist expects to encounter in clinical practice. The level and stability and leakage of leakage should be measured and if necessary, subtracted from each reading. For a fixed position in the calibrator and type of source, the response of the instrument should be linear within 2%.

d. For Cs-137 intracavitary sources and Ir-192 seeds, the instrument response should be

measured as a function of source position on the axis. From this data, a table of source length correction factors, expressed in terms of active length or seed number, should be calculated.

e. The instrument response/unit air-kerma, strength for each source type used clinically must be

measured. These factors are obtained by placing sources, that have been calibrated in terms of air-kerma strength by an ADCL or NIST, in the calibration position and noting the reading. These measurements should be repeated several times over a 2-4 week period to assess precision of the calibration transfer. Ideally one scale (mgRaEq) should be used for all isotopes with varying correction factors (A procedure for easily verifying instrument response using a long-lived source of known strength must be developed).

For long-lived sources, a new NIST-traceable calibration shall be obtained every 5 years. For

short-lived sources (1-125 and Ir-192), calibrations shall be obtained every 2 years. This interval can be lengthened to four years if the calibration is verified relative to an instrument (RPC or another ROC affiliate) having a more current calibration (The isotope-dependent correction factors supplied with nuclear medicine dose calibrators have no relevance to brachytherapy calibration).

5. LDR Treatment Rooms All treatment rooms shall be reviewed for adequacy of structural shielding before putting them

into clinical service. This analysis should follow the methods outlined in NCRP Report 49 and account for maximum anticipated workload, radionuclide and occupancy and ensure that exposure limits outlined in 10 CFR part 20 are met. Confirmatory measurements should be made. Appropriate posting, access control, and emergency equipment shall be provided. For LDR remote afterloading devices, area monitors, door interlocks and remote viewing devices are generally required by the terms of our NRC license. Remote afterloading devices can not be

-47-

relocated without receiving NRC license amendment approval. A temporary implant patients must be medically confined. If the exposure rate 1 m from such patients exceeds 2 mR/h or is likely to expose members of the public to dose equivalents exceeding 100 mR over the course of the implant, the patient must be confined to a previously approved treatment room staffed by nursing personnel that have received annual training as specified by CFR parts 20 and 35.

6. Commissioning of Remote Afterloading Devices. LDR remote afterloading commissioning is similar in content and approach to HDR machine

commissioning a. Source calibration and commissioning as described above for manual sources. b. Positional accuracy: The main test will be to verify that actual radioactive source locations

agree within 1-2 mm with dummy sources used for radiographic examination of the implant or other information used by the radiation oncologist to prescribe active source locations. A jig for daily and quarterly verification of source position shall be developed and validated. The correctness of source selection shall be verified. Applicators will be commissioned as described above for manual brachytherapy.

c. Verification of timer end effect and source transfer velocity, d. Verification of all major safety interlocks and fault detection features to the extent allowed by

the machine design. Verification of all audible and visual treatment status indicators. Verification of correct operation of all ancillary safety and treatment accessories.

e. Radiation survey around the machine with sources in retracted position f. Integration of the device into clinical practice, including development of dosimetric modeling,

revision of prescription, QA and source inventory forms, development of written clinical procedures, and development of a periodic QA protocol.


Prior to clinical implementation, recently acquired or updated computer treatment planning systems shall be subjected to the appropriate subset of accuracy/function tests listed in the table included in section IV.D

B. Annual Review(s)

For each clinic the responsible brachytherapy physicist shall perform an annual QA review which shall include the following tests. The form of the report shall consist of a brief summary describing the test outcomes, acquisition of any new reviewable equipment, any deviations from stated QA criteria and any corrective actions. Each test (accept calibrator QA) should be documented on the appropriate form which should be appended to the report and shall be submitted to the Brachytherapy Physics Service Chief for review.

1. Manual Brachytherapy

a. Review of calibration instrumentation, including verification of linearity, stability of response

relative to a calibrated Cs- 137 standard, and the results of recalibration against any new short-lived source standards acquired during the year. The age of all short-lived calibration factors should be listed. If the device is used to calibrate radiopharmaceutical doses, e.g., 1-131, note that the NRC requires quarterly verification of linearity and absolute response against NIST-traceable radioactivity standards.

-48-

b. Verification, against NIST-traceable air-kerma strength standards, of the inventory value of each long-lived source to confirm that the group average deviation is maintained within 3% with no individual source deviation exceeding 5%. See form in Appendix

c. Visual and orthogonal radiographic evaluation of shielded brachytherapy applicators,

checking for source placement (1 mm) and shielding integrity and position. See form in Appendix

d. Computer point-dose calculations shall be compared to manual or independent computer

calculations (stating technique or reference). Input data should be verified, followed by comparison of doses at several points. For example, points transverse to the source should be compared from 5 mm to 50 mm with no difference >3%. Longitudinally within the same distance, no deviation >10% should exist (see form in Appendix). Standard benchmark linear source and point source plans should be run and checked for accuracy. Geometric accuracy of peripheral 1/0 devices should be checked.

2. Remote Afterloading Devices

a. Source strength verification for long lived radionuclides b. Verification of positional accuracy: actual source location vs. simulation marker. Verification

that the autoradiographic jig used for quarterly and daily positional accuracy checking is itself accurate.

c. Radiographic verification of shielded applicator integrity and positional accuracy d. Radiation survey around device with sources retracted. e. Verification of timer accuracy, timer linearity and source transit time. f. Verify correct operation of any important safety interlock or fault detection capability not

covered by the quarterly QA protocol.

C. Quarterly and Monthly Checks 1. A radiation survey must be conducted quarterly in all regions surrounding and within isotope

storage areas. They must be conducted with a calibrated survey meter. This report requires the signature of the RSO.

2. Complete inventory of stored sources with correctly stated activities. This report requires the

signature of the RSO. 3. Remote Afterloading Devices a. Correct function of treatment status indicators, alarms, and door interlocks. Correct responses

to loss of air pressure and power. b. Ancillary safety devices/regulatory requirements: Correct function of CCTV viewing system,

intercom and independent area monitor. Room correctly posted and NRC "notification to workers" posted. Daily QA records complete.

c. General machine condition including connectors, transfer tubes, air compressors and

simulation markers. Correct execution of at least one simulated treatment cycle. d. Spot check of timer accuracy,

-49-

e. Autoradiograph of remote afterloader inventory. This should be used to check relative positional accuracy, delivery of each sequence to correct applicator, and number of sources stored in remote afterloader safe.

f. For LDR remote afterloading devices, our NRC license requires monthly verification of timer

accuracy, timer linearity, positional accuracy (satisfied by daily autoradiograph) and correct response to power failure.

D. Treatment-Specific QA


a. General Guidelines - Prior to insertion, applicators (especially infrequently used or unfamiliar ones) should be

reviewed for correct function and completeness. - Unusual procedures, involving construction of a specialized device (e.g., mold or template),

target volume localization from imaging studies, infrequently used applicators, or pre-insertion implant design and optimization should be brought to the attention of physicist well in advance of the procedure.

- Upon scheduling an interstitial implant, the attending physician's requirements (implant

design and target volume dimensions (where appropriate), dose rate, special problems, etc.) should be communicated to the physicist. Preplanning of interstitial implants, either by manual calculation or isodose plot computation, to estimate the strength and number of sources needed, is recommended.

- To order interstitial sources, an Isotope Request Form (Appendix IV) shall be completed by

the attending physician or physicist, the sources ordered by the physicist, and the form faxed to the Radiation Safety Office so they are prepared to receive the radioactive source shipment.

- Daily QA can be performed by a technologist or dosimetrist and shall be performed within

the 24-hour period preceding each clinical treatment. The protocol consists of reviewing critical interlocks, emergency responses, treatment status indicators, and safety features. In addition, the Radiation Oncology Center protocol requires an independent spot check of timer accuracy. This can be performed by timing, with a stopwatch, the duration of "Beam On" light during a programmed source exposure or an ionchamber source output test. If patient-specific autoradiographic treatment program verification is not performed, an autoradiographic check of positional accuracy shall completed.

b. Short-lived Source receipt and quality assurance

- Sealed sources: Vendor documentation must agree as to isotope, form, and strength. Source

must have been leak tested with last 6 months. Package must have surveyed by Radiation Safety and the outer container wipe tested.

- Verification of vendor calibration against NIST standards of at least 3 ribbons or sources or

15% of the shipment (whichever is greater). The number of sources or ribbons must be counted. For the calibration sample, the seed spacing should be counted and the seed number/ribbon counted. The Source Receipt Form, an integral part of the ROC inventory system, should be used. All sealed source calibration measurements shall be reviewed by an Authorized Medical Physicist.

-50-

- Paperwork documenting vendor calibration, receipt, leak tests, and number of sources should be appended to Source Receipt Form.

c. Remote afterloading devices: Daily QA protocol

- The daily QA protocol shall be performed within the 24-hour period preceding each clinical

treatment utilizing a remote afterloading device. The tests can be performed by a technologist, dosimetrist, physician or physicist. The protocol consists of reviewing critical interlocks, emergency responses, treatment status indicators, and safety features as specified in the attached appendices. The patient-specific autoradiograph serves as a source position accuracy test.

2. Applicator Insertion Procedure

A brachytherapy technologist should attend the surgical procedure with the radiation oncologist

when feasible or necessary. Their duties are to assist the radiation oncologist, verify the identity and dimensions of inserted applicators, document the implant geometry, applicator dimensions and any information needed to localize the target volume.

3. Radiographic Evaluation of Implant With the exception of radio-opaque applicators (e.g., eye plaques) or surface dose applicators of

fixed and known source geometry, the geometry and location of all sealed source implants shall be documented radiographically. Other types of views (stereo shift, oblique) should be obtained as required to accurately identify source locations for treatment planning. In the case of interstitial implants or any unusual procedure, the physicist and dosimetrist should be consulted regarding dummy source positioning, implant documentation, other measurements required for localization and film quality and adequacy. If the patient must be sent to simulation with temporary or permanent implant sources in place, alert all possible exposed personnel and radiation safety.

4. Prescription A prescription, adhering to WUMS QMP requirements, must be completed and signed by a

physician, on the prescription form Appendix IV, authorized to perform brachytherapy before loading the implant. At this time, the physician should review the implant radiographs. A copy of the completed prescription and the radiographs indicating where the sources are to be loaded should be forwarded to the physicist or dosimetrist responsible for isodose calculation. The original prescription form should remain in Staff room 2 whenever radioactive sources are in the patient.

5. Manual Afterloading: Source Preparation, Source Loading and Room Posting

- The individual responsible for source preparation (usually a brachytherapy technologist) shall have a copy of the prescription available for use in guiding source selection and preparation.

- Source strength and identity will be verified by color coding/source location for intracavitary

sources. For short-lived interstitial sources, the batch number will be checked against the prescription and the strength of one or two sources checked in the re-entrant ion chamber.

- Sources shall be placed in a shielded transport container which is clearly labeled indicating the

patient name, radionuclide, number of sources/ribbons, nominal source strength (and batch no. for interstitial seeds) and date. All source transactions shall be documented both in a written record (conforming to 10 CFR Part 35 and Regulatory Guide 10.8) and visually on the source inventory board in the Cesium Room.

-51-

- Normally, source loading will be performed by a radiation oncology physician accompanied by a physics staff member who assists and shall confirm that the prescription has been accurately followed. Should a physician not be immediately available, a physicist and brachytherapy technologist may load the implant together and checked by a physician before the end of the day.

- Following loading, an calibrated ion chamber survey meter shall be used to measure ambient

exposure rates in all areas surrounding the treatment room. For routinely used rooms, pretabulated exposure-rate tables may be used to estimate exposure rates in rooms above and below the radioactive patient. Post room with: Radioactive Materials sign, Radiation Area sign, Nursing and visitor time limits, room survey results, nursing and visitor instructions and emergency procedures. Hospital chart should include prescription, implant information, and physician phone number. A copy of the patient's current prescription shall be attached to patient's hospital chart.

6. Remote Afterloading: Source Preparation, Programming, and Room Posting

- Before initiating a patient treatment, the remote afterloading daily QA protocol shall be

completed. - The individual responsible for remote afterloader programming (usually a brachytherapy

technologist) shall have a copy of the prescription. - The accuracy of source positioning, arrangement and number will be verified autoradiographing

the programmed source configuration. This film must be reviewed and approved by a physician or physicist prior to initiating treatment. It shall be reviewed by a physicist by the end of the day on which treatment commences.

- Before initiating treatment, the setup must be checked by a radiation oncology physician and

the treatment program reviewed against the treatment prescription. Should a physician not be immediately available, a physicist may review the patient's setup, the treatment program and autoradiograph and initiate treatment in behalf of the physician. However, the responsible physician must complete this review by the end of the day.

- Following treatment initiation, the room shall-be surveyed and posted as described above. - Source utilization must be documented in writing as required by Regulatory Guide 10.8.

7. QA Responsibilities During Treatment

- Inpatient nursing staff are expected to control access to treatment rooms by nonoccupationally

exposed healthcare personnel and the general public, to recognize clinical and technical emergency situations and call the appropriate personnel, and to be able to disconnect patients from remote afterloading devices in event of a medical emergency. Specifically, nurses are to assess patient condition and compliance about every two hours. Nurses are to visually examine the implant site and check for significant displacement of the applicator system at intervals not to exceed 8 hours. This check should be documented in writing.

- For LDR implants, temporal accuracy requires careful documentation of source loading and

removal times, and prompt removal of sources at the scheduled time. The physicist on call shall be responsible for verifying removal of temporary implant sources at the appropriate time. The on-call physicist will be responsible for maintaining a list of implant patients which includes the expected source removal time (with a margin for remotely-afterloaded patients). For manually loaded implants, the physician removing the sources will page the on-call physicist to confirm source removal. For remotely-afterloaded implants, the on-call physicist will contact each patient's nurse to confirm automatic retraction of the sources.

-52-

- A nurse trained in the care of radioactive patients and operation of remote afterloading devices

(if used) shall-be on the unit at all times. Only nurses with current training may care for radioactive patients.

- A physicist is to be on call and to respond to all technical and safety-related inquiries and problems. For remotely-afterloaded implants, an attending physician authorized to perform brachytherapy shall be on-call per NRC license requirements.

- A physician should check the patient and applicator positioning at least once per day and record

any findings in the hospital chart. For remotely afterloaded patients, a brachytherapy technologist shall check applicator positioning and the printed treatment record on a daily basis and document the check on the printed tape.

- The on-call physicist shall be notified in the event that treatment is terminated prematurely.

Premature interruption of a treatment by the patient, if promptly detected and not due to errors on the part of the caregivers, is not grounds for a misadministration. In such a situation, an authorized physician shall document the incident on the yellow Prescription Form, including the duration of treatment actually delivered and the cause was patient intervention. This note must be signed and dated within 48 hours of the incident. Also see the WUSM Radiation Safety Manual.

- For remotely afterloaded patients, NRC requires constant visual surveillance by remote CCTV

monitors. This is interpreted to mean that the CCTV monitor shall be located at main nursing desk and that this area shall be staffed at all times.

- For remotely-afterloaded implants, only the patient is allowed to occupy the room when the

sources are exposed. The treatment unit is to remain chained to the wall and the operator's key secured during treatment.

- In-service training must include procedures to alert backup personnel should the physician

responsible for implant removal not show up. The on-call physicist will be responsible for verifying manually-afterloading source removal and remotely-afterloading source retraction by means of telephone contact with nursing staff or responsible physician. (See detailed procedure.)

8. Isodose and Treatment Time Calculation

- Treatment time calculations shall be reviewed and signed by an authorized physician. All

treatment-time calculations shall be checked by a physicist by the end of the day on which treatment was initiated. If definitive treatment-time calculations require computer plans that are not available at the time of loading, treatment can be initiated based on estimated treatment times and prescription dose rates. The estimated treatment time shall be documented in the written prescription and maybe revised at any time prior to completion of the treatment.

- Graphic treatment plans (isodoses) shall be generated, and if treatment time calculation depends

significantly on the results, they shall be reviewed by a physicist during the first half of the treatment and shall be made available for review and signature by an authorized physician. When graphic treatment plans are used only to document the dose distribution delivered and are not needed to identify the final loading and treatment time, they should be reviewed by a physicist before treatment is complete and signed by an authorized physician as soon as possible.

- The physics Treatment Plan and Documentation Review, as outlined in appendix III, should be

followed. This includes review of prescription, plan input data, assessment of positional accuracy, verification of all dose calculations, and review of clinical adequacy.

-53-

9. Source and Applicator Removal

- Sources and applicators are to be removed by a radiation oncology physician. Should a physician not be available, intracavitary sources maybe removed by an authorized physician resident .

- Upon removing sources, the physician shall-count the number of intracavitary sources or

interstitial ribbons. After returning the sources to the Cesium room, the physician will perform a second inventory, including a seed-by-seed count of interstitial seeds, using the L-block for exposure protection.

- Following removal of the radioactive sources from the patient's room, a careful survey of the

patient and the treatment room shall be performed using a GM detector and documented on the Prescription and Survey Results form. Should remotely-afterloaded sources fail to retract at the end of treatment or in response to an interruption command, the Selectron LDR emergency will be promptly initiated.

- Manual afterloading sources shall be inventoried and returned to their permanent storage

locations by the brachytherapy technologist during first business day following completion of the patient's treatment.

- Per NRC license requirements, LDR remote afterloader treatment rooms are to be locked when

not in use.

10. Release of Permanent Implant Patients

- Permanent implant patients may be released from confinement with no restrictions if the total dose equivalent to any other individual is not likely to exceed 500 mR total. This determination will be made by measuring the exposure rate at 1 m using a calibrated ion chamber survey meter. Per 10 CFR 35.75(c), the basis of release must be documented. If the dose equivalent to any individual is likely to exceed 100 mR, the patient must be provided with oral and written instructions. A card documenting the radioisotope and total source strength, together with the implant date, should be given to patient prior to patient release.

E. Source Disposal

1. All sources being shipped must be accompanied by proper shipping forms. A contact and 1 m

exposure-rate measurement shall be and the container labeled in accord with D.O.T./NRC regulations. A leak test must be performed if the time limit (6 months in most cases) duration has been exceeded. At WUMS, the Radiation Safety Office should be called to inspect the package and authorize final shipment

2. Assurance must be made that the recipient is licensed to receive the particular isotope. 3. A complete inventory of shipped and remaining sources must be performed. The appended

source inventory system includes a form to facilitate return of short-lived sealed sources. X. CONTINUING EDUCATION

All operators (residents, dosimetrists, brachytherapy technologists, etc.), as well as all nursing personnel caring for implanted patients shall receive annual in-services covering basic radiation safety, source handling, emergency procedures, etc. as indicated in the following table. Authorized physicians are generally exempt from training requirements. However, an exception is the requirement that authorized user of HDR brachytherapy have an annual training session on normal and emergency operating procedures.

-54-

Target Audience Instructor Venue and Topics Required Frequency

All badged Radiation Oncology Personnel

Radiation Safety Officer

Annual Review of Review of Radiation Safety Procedures and Regulations

Every 12 months

Physician Residents Physics Residents Brachy. Techs Brachy. Researchers Brachy. Physicists

Brachy. Physicists

Three times per year - Basic clinical source handling procedures and regulations - HDR emergency procedures and Quality Management Program requirements* - Special Topic

100% attendance expected; at least one attendance per 12 months required

Brachy. Techs. Brachy. Researchers Brachy. Physicists (all HDR unit operators) Authorized users Nurses

Nucletron Engineers for new unit brachy. Physicists thereafter

HDR remote afterloader operating procedures and emergency procedures*

Every 12 months

Brachy. Techs. Brachy. Physicists Implant Residents (all operators)

Brachy. Physicists

LDR remote afterloader operating procedures and emergency procedures*

Every 12 months

4400, 4900 and 7100 unit clerks, nurses and PCT's

Brachy. Physicists

Ionizing radiation concepts, general precautions/ procedures, duties and responsibilities, treatment-type specific procedures

Every 12 months

Brachytherapy Dosimetry Laboratory Personnel

Chief, Brachy. Phys.

Laboratory source handling, safety and regulatory procedures

Every 12 months

Residents who take implant call and independently load/ unload patients

Brachy. Phys., Brachy. Techs., Outgoing GYN res., Brachy. Attending

See detailed BJH policy. Orientation, three ICT removals, and two I-131 administrations, all supervised by attending physician or resident who has completed safety training

-55-

Approved By: Date: Perry W. Grigsby, M.D. Professor and Chief of Brachytherapy Services Jeffrey M. Michalski, M.D. Associate Professor and Clinical Director Susan Richardson, Ph.D Chief of Brachytherapy Physics Service Simon N. Powell, M.D. Professor and Chairmen Department of Radiation Oncology

Date post:	02-Mar-2020
Category:	Documents
Upload:	others
View:	3 times
Download:	0 times

Brachytherapy and Radiopharmaceutical Quality...

Documents