Regulatory Guide 8.33

(Task DG-8001), Quality Management Program

ML003739489
Person / Time
Issue date:	10/31/1991
From:	Office of Nuclear Regulatory Research
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U.S. NUCLEAR REGULATORY COMMISSION October 1991 REGULATORY GUIDE

OFFICE OF NUCLEAR REGULATORY RESEARCH

REGULATORY GUIDE 8.33 (Task DG-8001)

QUALITY MANAGEMENT PROGRAM

USNRC REGULATORY GUIDES The guides are issued in the following ten broad divisions:

Regulatory Guides are Issued to describe and make available to the pub lic methods acceptable to the NRC staff of Implementing specific parts of the Commission's regulations, to delineate techniques used by the 1. Power Reactors 6. Products staff In evaluating specific problems o. postulated accidents, or to pro 2. Research and Test Reactors 7. Transportation vide guidance to applicants. Regulatory Guides are not substitutes for 3. Fuels and Materials Facilities 8. Occupational Health regulations, and compliance with them is not required. Methods and 4. Environmental and Siting 9. Antitrust and Financial Review solutions different from those set out In the guides will be acceptable If 5. Materials and Plant Protection 10. General they provide a basis for the findings requisite to the issuance or continu ance of a permit or license by the Commission.

Copies of issued guides may be purchased from the Government Printing This guide was Issued after consideration of comments received from Office at the current GPO price, Information on current GPO prices may the public, Comments and suggestions for Improvements In these be obtained by contacting the Superintendent of Documents, U.S. Gov guides are encouraged at all times, and guides will be revised, as ap ernment Printing Office, Post Office Box'37082, Washington, DC

propriate, to accommodate comments and to reflect new Information or 20013-7082, telephone (202)275-2060 or (202)275-2171.

experience.

Written comments may be submitted to the Regulatory Publications Issued guides may also be purchased from the National Technical Infor Branch, DFIPS, ARM, U.S. Nuclear Regulatory Commission, Washing mation Service on a standing order basis. Details on this service may be ton, DC 20555. obtained by writing NTIS, 5285 Port Royal Road, Springfield, VA 22161.

TABLE OF CONTENTS

Page

A. INTRODUCTION

............................................................... 8.33-1

B. DISCUSSION

........................................................ .......... .8.33-1

C. REGULATORY POSITION

....................................................... 8.33-1

1. Suggested Policies and Procedures for Certain Radiopharmaceutical Uses ............... 8.33-1

2. Suggested Policies and Procedures for Teletherapy ................................. 8.33-2

3. Suggested Policies and Procedures for Brachytherapy ............................... 8.33-4

3.1 High-Dose-Rate Remote Afterloading Devices ................................. 8.33-4

3.2 All Other Brachiytherapy Applications ........................................ 8.33-5

4. Suggested Policies and Procedures for Gamma Stereotactic Radiosurgery ............... 8.33-6

5. Oral Directives and Revisions to Written Directives ................................. 8.33-7

6. Periodic Reviews ............................................................. 8.33-7 D. IM PLEM ENTATION ............................................................ 8.33-8 BIBLIOGRA PH Y ................................................................... 8.33-9 REGULATORY ANALYSIS .......................................................... 8.33-10

iii

A. INTRODUCTION

" Procedures to confirm that, prior to administra tion, the person responsible for the treatment According to § 35.32, "Quality Management Pro modality will check the specific details of the gram," of 10 CFR Part 35, "Medical Use of written directive (e.g., in radiopharmaceutical Byproduct Material," applicants or licensees, as appli therapy, verify the radiopharmaceutical, dosage, cable, are required to establish a quality management and route of administration; or in oncology, ver (QM) program. This regulatory guide provides guid ify the treatment site, total dose, dose per frac ance to licensees and applicants for developing poli tion, and overall treatment period),

cies and procedures for the QM program. This guide " Procedures to record the radiopharmaceutical does not restrict or limit the licensee from using other dosage or radiation dose actually administered.

guidance that may be equally useful in developing a QM program, e.g., information available from the

C. REGULATORY POSITION

Joint Commission on Accreditation of Healthcare Organizations or the American College of Radiology. This regulatory guide provides guidance to licen sees and applicants for developing a quality manage Any information collection activities mentioned ment program acceptable to the NRC staff for comply in this regulatory guide are contained as requirements ing with 10 CFR 35.32. However, a licensee or in 10 CFR Part 35, which provides the regulatory basis applicant may use other sources of guidance and for this guide. The information collection require experience in addition to or in lieu of this regulatory ments in 10 CFR Part 35 have been cleared under guide. The NRC staff would review such a program on OMB Clearance No. 3150-0010. a case-by-case basis.

B. DISCUSSION

The licensee's QM program should contain the.

essential elements of the policies and procedures listed The administration of byproduct material can be a in the following sections.

complex process for many types of diagnostic and

1. SUGGESTED POLICIES AND

therapeutic procedures in nuclear medicine or oncol PROCEDURES FOR CERTAIN

ogy departments. A number of individuals may be RADIOPHARMACEUTICAL USES

involved in the delivery process. For example, in an oncology department when th6 authorized user pre 1.1. The licensee should establish a policy to scribes a teletherapy treatment, the delivery process have an authorized user date and sign a written may involve a team of medical professionals such as a directive prior to the administration of any therapeutic radiation therapy physicist, dosimetrist, and radiation dosage of a radiopharmaceutical or any dosage of therapy technologist. Conducting the plan of treat quantities greater than 30 microcuries of either sodium ment may involve a number of measurements, calcula iodide 1-125 or 1-131. A written directive is required tions, computer-generated treatment plans, patient by 10 CFR 35.32(a) (1). Procedures for oral directives simulations, portal film verifications, and beam and revisions to written directives are contained in modifying devices to deliver the prescribed dose. Regulatory Position 5.

Therefore, instructions must be clearly communicated to the professional team members with constant atten 1.2. Before administering a radiopharmaceutical tion devoted to detail during the treatment process. dosage, the licensee should establish a procedure to Complicated processes of this nature require good verify by more than one method the identity of the planning and clear, understandable procedures. patient as the individual named in the written direc tive. Identifying the patient by more than one method The administration of byproduct material or radia is required by 10 CFR 35.32(a) (2). The procedure tion from byproduct material can involve a number of used to identify the patient should be to ask the treatment modlities, e.g., radiopharmaceutical ther patient's name and confirm the name and at least one apy, teletherapy, brachytherapy, or gamma stereotac of the following by comparison with corresponding tic radiosurgery. For each modality, this regulatory information in the patient's record: birth date, ad guide recommends specific policies or procedures to dress, social security number, signature, the name on ensure that the objectives of 10 CFR 35.32 are met. the patient's ID bracelet or hospital ID card, or the In general, this guide recommends that licensees have: name on the patient's medical insurance card.

Policies to have an authorized user date and sign 1.3. The licensee should establish a procedure a written directive prior to the administration, to verify, before administering the byproduct mate rial, that the specific details of the administration are Procedures to identify the patient by more than in accordance with the written directive. The radio one method, pharmaceutical, dosage, and route of administration Procedures to be sure the plans of treatment are should be confirmed by the person administering the in accordance with the written directive, radiopharmaceutical to verify agreement with the writ-

8.33-1

ten directive, that is, the dosage should be measured of treatment may be obtained from the American in the dose calibrator and the results compared with College of Radiology.

the prescribed dosage in the written directive.

2.4. The licensee should establish a procedure

1.4. The licensee should establish a policy for all to verify, before administering each teletherapy dose, workers to seek guidance if they do not understand that the specific details of the administration are in how to carry out the written directive. That is, workers accordance with the written directive and plan of should ask if they have any questions about what to do treatment. In .particular, the treatment site and the or how it should be done rather than continuing a dose per fraction should be confirmed by the person procedure when there is any doubt. administering the teletherapy treatment to verify agreement with the written directive and plan of

1.5. The licensee should establish a procedure treatment.

to have an authorized user or a qualified person under the supervision of an authorized user (e.g., a 2.5. The licensee should establish a policy for all nuclear medicine physician, physicist, or technolo workers to seek guidance if they do not understand gist), after administering a radiopharmaceutical, how to carry out the written directive. That is, workers make, date, and sign or initial a written record that should ask if they have any questions about what to do documents the administered dosage in the patient's or how it should be done rather than continuing a chart or other appropriate record. The responsibilities procedure when there is any doubt.

and conditions of supervision are contained in 10 CFR 35.25. A record of the administered dosage is re 2.6. The licensee should establish a procedure quired by 10 CFR 35.32(d)(2). to have a qualified person under the supervision of an authorized user (e.g., an oncology physician, radiation

1.6. The licensee should establish procedures to therapy physicist, dosimetrist, or radiation therapy perform periodic reviews of the radiopharmaceutical technologist), after administering a teletherapy dose QM program. Guidance. on periodic reviews is pro fraction, make, date, and sign or initial a written vided in Regulatory Position 6. A QM program review record in the patient's chart or in another appropriate is required by 10 CFR 35.32(b). record that contains, for each treatment field, the treatment time, dose administered, and the cumula

2. SUGGESTED POLICIES AND tive dose administered. The responsibilities and condi PROCEDURES FOR TELETHERAPY tions of supervision are contained in 10 CFR 35.25. A

record of the administered dose is required by 10 CFR

2.1. The licensee should establish a policy to 35.32(d) (2).

have an authorized user date and sign a written directive prior to the administration of any teletherapy 2.7. The licensee should establish a procedure to have a weekly chart check performed by a qualified dose. A written directive is required by 10 CFR 35.32(a) (1). Procedures for oral directives and revi person under the supervision of an authorized user sions to written directives are contained in Regulatory (e.g., a radiation therapy physicist, dosimetrist, oncol Position 5. ogy physician, or radiation therapy technologist) to detect mistakes (e.g., arithmetic errors, miscalcula tions, or incorrect transfer of data) that may have

2.2. Before administering a teletherapy dose, occurred in the daily and cumulative teletherapy dose the licensee should establish a procedure to verify by administrations from all treatment fields or in connec more than one method the identity of the patient as tion with any changes in the written directive or plan the individual named in the written directive. Identify of treatment. The responsibilities and conditions of ing the'patient by more than one method is required supervision are contained in 10 CFR 35.25.

by 10 CFR 35.32(a)(2). The procedure used to identify the patient should be to ask the patient's 2.8. If the prescribed dose is to be administered name and confirm the name and at least one of the in more than three fractions, the licensee should following by comparison with the corresponding infor establish a procedure to check the dose calculations nation in the patient's record: birth date, address, within three working days after administering the first social security number, signature, the name on the teletherapy fractional dose. An authorized user or a patient's ID bracelet or hospital ID card, the name on qualified person under the supervision of an author the patient's medical insurance card, or the photo ized user (e.g., a radiation therapy physicist, oncology graph of the patient's face. physician, dosimetrist, or radiation therapy technolo gist), who whenever possible did not make the original

2.3. The licensee should establish a policy to calculations, should check the dose calculations. If the have an authorized user approve a plan of treatment prescribed dose is to be administered in three frac that provides sufficient information and direction to tions or less, a procedure for checking dose calcula meet the objectives of the written directive. Suggested tions as described in this paragraph should be per guidelines for information to be included in the plan formed before administering the first teletherapy

8.33-2

fractional dose. The responsibilities and conditions of (2) A teletherapy physicist (or an oncology supervision are contained in 10 CFR 35.32. physician, dosimetrist, or radiation therapy technolo gist who has been properly instructed) using a ther Manual dose calculations should be checked for: moluminescence dosimetry service available by mail that is designed for confirming teletherapy doses and

(1) Arithmetic errors, that is accurate within 5 percent.

(2) Appropriate transfer of data from the writ 2.10. The licensee should establish a procedure ten directive, plan of treatment, tables, and graphs, to have full calibration measurements (required by 10

CFR 35.632) include the determination of transmis

(3) Appropriate use of nomograms (when ap sion factors for trays and wedges. Transmission factors plicable), and for other beam-modifying devices (e.g., nonrecastable blocks, recastable block material, bolus and compen

(4) Appropriate use of all pertinent data in the sator materials, and split-beam blocking devices)

calculations. should be determined before the first medical use of the beam-modifying device and after replacement of Computer-generated dose calculations should be the source.

checked by examining the computer printout to verify that the correct data for the patient were used in the 2.11. The licensee should establish a procedure calculations (e.g., patient contour, patient thickness at to have a physical measurement of the teletherapy the central ray, depth of target, depth dose factors, output made under applicable conditions prior to treatment distance, portal arrangement, field sizes, or administration of the first teletherapy fractional dose if beam-modifying factors). Alternatively, the dose the patient's plan of treatment includes (1) field sizes should be manually calculated to a single key point or treatment distances that fall outside the range of and the results compared to the computer-generated those measured in the most recent full calibration or dose calculations. (2) transmission factors for beam-modifying devices (except nonrecastable and recastable blocks, bolus If the manual dose calculations are performed and compensator materials, and split-beam blocking using computer-generated outputs or vice versa, par devices) not measured in the most recent full calibra ticular emphasis should be placed on verifying the tion measurement.

correct output from one type of dose calculation (e.g.,

computer) to be used as an input in another type of 2.12. If the authorized user determines that de dose calculation (e.g., manual). Parameters such as laying treatment to perform the checks of (1) dose the transmission factors for wedges and the source calculations for a prescribed dose that is administered strength of the sealed source used in the dose calcula in three fractions or less (see Regulatory Position 2.8)

tions should be checked. or (2) teletherapy output (see Regulatory Position

2.11) would jeopardize the patient's health because of

2.9. The licensee should establish a procedure the emergent nature of the patient's medical condi for independently checking certain full calibration tion, the prescribed treatment may be provided with measurements as follows: out first performing the checks of dose calculations or physical measurements. The authorized user should After full calibration measurements that resulted make a notation of this determination in the records from replacement of the source, or whenever spot of the calculated administered dose. The checks of check measurements indicate that the output differs the calculations should be performed within two work by more than 5 percent from the output obtained at ing days of completion of the treatment.

the last full calibration corrected mathematically for radioactive decay, an independent check of the out 2.13. The licensee should establish a procedure put for a single specified set of exposure conditions for performing acceptance testing by a qualified should be performed. The independent check should person (e.g., a teletherapy physicist) on each treat be performed within 30 days following such full cali ment planning or dose. calculating computer program bration measurements. that could be used for teletherapy dose calculations.

Acceptance testing should be performed before the The independent check should be performed by first use of a treatment planning or dose calculating either: computer program for teletherapy dose calculations.

Acceptance testing should also be performed after full

(1) An individual who did not perform the full calibration measurements when the calibration was calibration (the individual should meet the require performed (1) before the first medical use of the ments specified in 10 CFR 35.961) using a dosimetry teletherapy unit, (2) after replacement of the source, system other than the one that was used during the full or (3) when spot-check measurements indicated that calibration (the dosimetry system should meet the the output differed by more than 5 percent from the requirements specified in 10 CFR 35.630(a)), or output obtained at the last full calibration corrected

8.33-3

mathematically for radioactive decay. Computer or how it should be done rather than continuing a generated beam data should be compared to meas procedure when there is any doubt.

ured beam data from the teletherapy unit. The licen see should assess each treatment planning or dose 3.1.5. The licensee should establish a proce calculating computer program based on the licensee's dure for using radiographs or other comparable images specific needs and applications. (e.g., computerized tomography) as the basis for verifying the position of the nonradioactive "dummy"

2.14 The licensee should establish procedures to sources and calculating the administered perform periodic reviews of the teletherapy QM brachytherapy dose before inserting the sealed program. Guidance on periodic reviews is provided in sources.

Regulatory Position 6. A QM program review is re quired by 10 CFR 35.32(b). 3.1.6. The licensee should establish a proce dure to check the dose calculations before administer

3. SUGGESTED POLICIES AND ing the prescribed brachytherapy dose. An authorized PROCEDURES FOR BRACHYTHERAPY user or a qualified person under the supervision of an authorized user (e.g., a radiation therapy physicist,

3.1 High-Dose-Rate Remote Afterloading Devices oncology physician, dosimetrist, or radiation therapy technologist), who whenever possible did not make Similar licensee policies and procedures for low the original calculations, should check the dose calcu and medium-dose-rate remote afterloading devices lations. The responsibilities and conditions of "super would be equally helpful. vision" are contained in 10 CFR 35.25. Suggested methods for checking the calculations include the

3.1.1. The licensee should establish a policy to following:

have an authorized user date and sign a written directive prior to the administration of any

" Computer-generated dose calculations should be brachytherapy dose from a high-dose-rate remote checked by examining the computer printout to verify that correct input data for the patient were afterloading device. A written directive is required by

10 CFR 35.32(a)(1). Procedures for oral directives used in the calculations (e.g., source strength and positions).

and revisions to written directives are contained in Regulatory Position 5. "* The computer-generated dose calculations for in put into the brachytherapy afterloading device

3.1.2. Before administering a brachytherapy should be checked to verify correct transfer of treatment, the licensee should establish a procedure to data from the computer (e.g., channel numbers, verify by more than one method the identity of the source positions, and treatment times).

patient as the individual named in the written direc 3.1.7. The licensee should establish a proce tive. Identifying the patient by more than one method dure to have an authorized user, after administering is required by 10.CFR 35.32(a)(2). The procedure the brachytherapy treatment, date and sign or initial a used to identify the patient should be to ask the written record of the calculated administered dose in patient's name and confirm the name and at least one the patient's chart or in another appropriate record. A

of the following by comparison with the corresponding record of the administered dose is required by 10 CFR

information in the patient's record: birth date, ad 35.32(d) (2).

dress, social security number, signature, the name on the patient's ID bracelet or hospital ID card, the name 3.1.8. If the authorized user determines that on the patient's medical insurance card, or the photo delaying treatment in order to perform the checks of graph of the patient's face. dose calculations (see Regulatory Position 3.1.6)

would jeopardize the patient's health because of the

3.1.3. The licensee should establish a proce emergent nature of the patient's medical condition, dure to verify, before administering the brachytherapy the checks of the calculations should be performed dose, that the specific details of the brachytherapy within two working days of the treatment.

administration are in accordance with the written directive and plan of treAtment. The prescribed radio 3.1.9. The licensee should establish a proce isotope, treatment site, and total dose should be dure for performing acceptance testing by a qualified confirmed by the person administering the person (e.`g., a teletherapy physicist) on each treat brachytherapy treatment to verify agreement with the ment planning or dose calculating computer program written directive and plan of treatment. that could be used for brachytherapy dose calculations when using high-dose-rate remote afterloading de

3.1.4. The licensee should establish a policy for vices. Acceptance testing should be performed before all workers to seek guidance if they do not understand the first use of a treatment planning or dose cFlculat how to carry out the written directive. That is, workers *The term sealed sources includes wires and encapsulated should ask if they have any questions about what to do sources.

8.33-4

ing computer program for brachytherapy dose calcula sources to be used are in agreement with the written tions when using high-dose-rate remote afterloading directive and plan of treatment before implanting the devices. The licensee should assess each treatment radioactive sealed sources.* The licensee may use any planning or dose calculating computer program based appropriate verification method, such as checking the on the licensee's specific needs and applications. serial number of the sealed sources behind an appro priate shield, using a radiation detector, using a dose

3.1.10. The licensee should establish proce calibrator, using color-coded sealed sources, or using dures to perform periodic reviews of the brachytherapy clearly marked storage locations, i.e., one location for QM program for using the high-dose-rate remote after each source strength. The responsibilities and condi loading device. Guidance on periodic reviews is provided tions of supervision are contained in 10 CFR 35.25.

in Regulatory Position 6. A QM program review is re

3.2.6. For temporary brachytherapy implants, quired by 10 CFR 35.32(b).

the licensee should establish a procedure for using

3.2. All Other Brachytherapy Applications radiographs or other comparable images (e.g., com puterized tomography) of brachytherapy radioactive

3.2.1. The licensee should establish a policy to sources or nonradioactive "dummy" sources in place have an authorized user date and sign a written as the basis for verifying the position of the sources directive prior to the administration of any and calculating the exposure time (or, equivalently, brachytherapy dose. A written directive is required by the total dose). Whenever possible, nonradioactive

10 CFR 35.32(a)(1). Procedures for oral directives "dummy" sources should be used before inserting the and revisions to written directives are contained in radioactive sources (e.g., cesium-137 sealed sources Regulatory Position 5. used for intracavitary applications). However, some brachytherapy procedures may require the use of

3.2.2. Before administering a brachytherapy various fixed geometry applicators (e.g., appliances or dose, the licensee should establish a procedure to templates) to establish the location of the temporary verify by more than one method the identity of the sources and calculate the exposure time (or, equiv patient as the individual named in the written direc alently, the total dose) required to administer the tive. Identifying the patient by more than one method prescribed brachytherapy treatment. In these cases, is required by 10 CFR 35.32(a)(2). The procedure radiographs or other comparable images may not be used to identify the patient should be to ask the necessary provided the position of the sources is patient's name and confirm the name and at least one known prior to inserting the radioactive sources and of the following by comparison with the corresponding calculating the exposure time (or, equivalently, the information in the patient's record: birth date, ad total dose).

dress, social security number, signature, the name on 3.2.7. For permanent brachytherapy implants, the patient's ID bracelet or hospital ID card, the name the licensee should establish a procedure for using on the patient's medical insurance card, or the photo radiographs or other comparable images (e.g.,

graph of the patient's face. computerized tomography) of brachytherapy radioac tive sources in place as the basis for verifying the'

3.2.3. The licensee should establish a proce position of the sources and calculating the total dose, dure to verify, before administering the brachytherapy if applicable, after inserting the sources (e.g.,

dose, that the specific details of the brachytherapy iodine-125 sealed sources used for interstitial applica administration are in accordance with the written tions). However, some brachytherapy procedures may directive and plan of treatment. In particular, the require the use of various fixed geometry applicators radioisotope, number of sources, and source strengths (e.g., templates) to establish the location of the should be confirmed to verify agreement with the sources and calculate the total dose, if applicable. In written directive and plan of treatment. these cases, radiographs or other comparable'images may not be necessary.

3.2.4. The licensee should establish a policy for all workers to seek guidance if they do not understand 3.2.8. After insertion of the temporary implant how to carry out the written directive. That is, workers brachytherapy sources (see Regulatory Position should ask if they have any questions about what to do 3.2.6), the licensee should establish a procedure to or how it should be done rather than continuing a have an authorized user promptly record the actual procedure when there is any doubt. loading sequence of the radioactive sources implanted (e.g., location of each sealed source in a tube,

3.2.5. The licensee should establish a proce tandem, or cylinder) and sign or initial the patient's dure to have an authorized user or a qualified person chart or other appropriate record.

under the supervision of an authorized user (e.g., a 3.2.9. After insertion of the permanent implant radiation therapy physicist, oncology physician, brachytherapy sources (see Regulatory Position dosimetrist, or radiation therapy technologist) verify that the radioisotope, number of sources, source *The term sealed sources includes wires and encapsulated strengths, and, if applicable, loading sequence of the sources.

8.33-5

3.2.7), the licensee should establish a procedure to within two working days of completion of the have an authorized user promptly record the actual brachytherapy treatment.

number of radioactive sources implanted and sign or initial the patient's chart or other appropriate record. 3.2.13. The licensee should establish a proce dure for performing acceptance testing by a qualified

3.2.10. The licensee should establish a proce person (e.g., a teletherapy physicist) on each treat dure to check the dose calculations before the total ment planning or dose calculating computer program prescribed brachytherapy dose has been administered. that could be used for brachytherapy dose calcula An authorized user or a qualified person under the tions. Acceptance testing should be performed before supervision of an authorized user (e.g., a radiation the first use of a treatment planning or dose calculat therapy physicist, oncology physician, dosimetrist, or ing computer program for brachytherapy dose calcula radiation therapy technologist), who whenever. possi tions. The licensee should assess each treatment plan ble did not make the original calculations, should ning or dose calculating computer program based on check the dose calculations. The responsibilities and the licensee's specific needs and applications.

conditions of supervision are contained in 10 CFR 35.25. Manual dose calculations should be checked 3.2.14. The licensee should establish procedures for: to perform periodic reviews of the brachytherapy QM

program. Guidance on periodic reviews is provided in

"* Arithmetic errors, Regulatory Position 6. A QM program review is re quired by 10 CFR 35.32(b).

"* Appropriate transfer of data from the written di rective, plan of treatment, tables, and graphs, 4. SUGGESTED POLICIES AND

"* Appropriate use of nomograms (when applica PROCEDURES FOR GAMMA

ble), and STEREOTACTIC RADIOSURGERY

"* Appropriate use of all pertinent data in the calcu 4.1. The licensee should establish a policy to lations. have an authorized user date and sign a written directive before administering treatment. A written Computer-generated dose calculations should be directive is required by 10 CFR 35.32(a)(1). Proce checked by examining the computer printout to verify dures for oral directives and revisions to written that the correct data for the patient were used i' the directives are contained in Regulatory Position 5.

calculations (e.g., position of the applicator or sealed sources, number of sources, total source strength, or 4.2. Before administering treatment, the licen source loading sequence). Alternatively, the see should establish a procedure .to verify by more brachytherapy dose should be manually calculated to than one method the identity of the patient as the a single key point and the results compared to the individual named in the written directive. Identifying computer-generated dose calculations. If the manual the patient by more than one method is required by dose calculations are performed using computer 10 CFR 35.32(a)(2). The procedure used to identify generated outputs (or vice versa), particular emphasis the patient should be to ask the patient's name and should be placed on verifying the correct output from confirm the name and at least one of the following by one type of calculation (e.g., computer) to be used as comparison with the corresponding information in the an input in another type of calculation (e.g., manual). patient's record: birth date, address, social security number, signature, the name on the patient's ID

3.2.11. The licensee should establish a proce bracelet or hospital ID card, the name on the patient's dure to have an authorized user date and sign or initial medical insurance card, or the photograph of the a written record in the patient's chart or in another patient's face.

.appropriate record after insertion of the brachytherapy sources but prior to completion of the 4.3. The licensee should establish a procedure procedure. The written record should include the to have the neurosurgeon, the oncology physician, radioisotope, treatment site, and total source strength and the radiation therapy, physicist date and sign a and exposure time (or, equivalently, the total dose). plan of treatment that includes, for each targit point, A record of the administered dose (or, equivalently, the coordinates, the plug pattern, the collimator size, the total source strength and exposure time) is re the exposure time, the target dose, and the total dose quired by 10 CFR 35.32(d)(2). before administering treatment.

3.2.12. If the authorized user determines that 4.4. The licensee should establish a policy for all delaying treatment in order to perform the checks of workers to seek guidance if they do not understand dose calculations (see Regulatory Position 3.2.10) how to carry out the written directive. That is, workers would jeopardize the patient's health because of the should ask if they have any questions about what to do emergent nature of the patient's medical condition, or how it should be done rather than continuing a the checks of the calculations should be performed procedure when there is any doubt.

8.33-6

4.5. The licensee should establish a procedure 5. ORAL DIRECTIVES AND REVISIONS TO

to verify, before administering each treatment, that WRITTEN DIRECTIVES

he specific details of the administration are in accor dance with the written directive and plan of treatment. A footnote to 10 CFR 35.32(a)(1) reads as fol The verification should be performed by at least one lows:

qualified person (e.g., an oncology physician, radia "If, because of the patient's medical condi tion therapy physicist, or radiation therapy technolo tion, a delay in order to provide a written revision gist) other than the individuals who dated and signed to an existing written directive would jeopardize the written directive and plan of treatment. Particular the patient's health, an oral revision to an existing emphasis should be directed toward verifying that the written directive will be acceptable, provided that stereotactic frame coordinates on the patient's skull match those of the plan of treatment. the oral revision is documented immediately in the patient's record and a revised written directive is dated and signed by the authorized user within 48

4.6. The licensee should establish a procedure hours of the oral revision.

to check computer-generated dose calculations by examining the computer printout to verify that correct "Also, a written revision to an existing written data for the patient were used in the calculations. directive may be made for any diagnostic or therapeutic procedure provided that the revision is dated and signed by an authorized user prior to

4.7. The licensee should establish a procedure the administration of the radiopharmaceutical to check that the computer-generated dose calcula dosage, the brachytherapy dose, the gamma tions were correctly input to the gamma stereotactic stereotactic radiosurgery dose, the teletherapy radiosurgery unit. dose, or the next teletherapy fractional dose.

4.8. The licensee should establish a procedure "If, because of the emergent nature of the to have the neurosurgeon or the oncology physician, patient's medical condition, a delay in order to after administering the treatment, date and sign or provide a written directive would jeopardize the initial a written record of the calculated administered patient's health, an oral directive will be accept dose in the patient's chart or in another appropriate able, provided that the information contained in record. A record of the administered dose is required the oral directive is documented immediately in by 10 CFR 35.32(d)(2). the patient's record and a written directive is prepared within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the oral directive."

4.9. If the authorized user determines that de

6. PERIODIC REVIEWS

laying treatment in order to perform the checks of the dose calculations (see Regulatory Positions 4.6 and The licensee should establish written procedures

4.7) would jeopardize the patient's health because of to conduct periodic reviews of each applicable pro the emergent nature of the patient's medical condi gram area, e.g., radiopharmaceuticals, teletherapy, tion, the checks of the calculations should be per brachytherapy, and gamma stereotactic radiosurgery.

formed within two working days of the treatment. The review should include, from the previous 12 months (or since the last review), a representative sample of patient administrations, all recordable

4.10. The licensee should establish a procedure events, and all misadministrations. The number of for performing acceptance testing by a qualified patient cases to be sampled should be based on the person (e.g., a teletherapy physicist) on each treat principles of statistical acceptance sampling and ment planning or dose calculating computer program should represent each treatment modality performed that could be used for gamma stereotactic radiosur in the institution, e.g., radiopharmaceutical, gery dose calculations. Acceptance testing should be teletherapy, brachytherapy, and gamma stereotactic performed before the first use of a treatment planning radiosurgery. For example, using the acceptance sam or dose calculating computer program for gamma pling tables of 10 CFR 32.110 and assuming an error stereotactic radiosurgery dose calculations. The licen rate (or lot tolerance percent defective) of 2 percent, see should assess each treatment planning or dose the number of patient cases to be reviewed (e.g., 115)

calculating computer program based on the licensee's based on 1000 patients treated would be larger than specific needs and applications. the number of patient cases to be reviewed (e.g., 85)

based on 200 patients treated. In order to eliminate

4.11. The licensee should establish procedures any bias in the sample, the patient cases to be to perform periodic reviews of the gamma stereotactic reviewed should be selected randomly. For each pa radiosurgery QM program. Guidance on periodic re tient's case, a comparison should be made between views is provided in Regulatory Position 6. A QM what was administered versus what was prescribed in program review is required by 10 CFR 35.32(b). the written directive. If the difference between what

8.33-7

was administered and what was prescribed exceeds the For gamma stereotactic radiosurgery: target co criteria for either a recordable event or a misadmin ordinates, collimator size, plug pattern, and total istration, that comparison is unacceptable. The num dose.

ber of "unacceptable comparisons" that is allowed for For each patient case reviewed, the licensee each sample size and lot tolerance percent defective is should identify deviations from the written directive, provided in the acceptance sampling tables of 10 CFR the cause of each deviation, and the action required

32.110. to prevent recurrence. The actions may include new or revised policies, new or revised procedures, addi These periodic reviews could be conducted tional training, or increased supervisory review of weekly, monthly, or quarterly if one of these periods is work.

more compatible with the licensee's operations.

The licensee should reevaluate the QM program's If feasible, the persons conducting the review policies and procedures after each annual review to should not review their own work. If this is not determine whether the program is still effective or to possible, two people should work together as a team to identify actions required to make the program more conduct the review of that work. The licensee or effective.

designee should regularly review the findings of the periodic reviews to ensure that the QM program is Program review results should be documented and effective. should be available for NRC inspectors. To obtain the maximum results from the lessons learned from each For each patient case reviewed, the licensee review, the program review reports should be distrib should determine whether the administered radio uted within the institution to appropriate management pharmaceutical dosage or radiation dose was in accor and departments. Corrective actions for deficient con dance with the written directive or plan of treatment, ditions should be implemented within a reasonable as applicable. For example, were the following cor time after identification of the deficiency.

rect:

D. IMPLEMENTATION

For radiopharmaceutical therapy: the radio pharmaceutical, dosage, and route of administra The purpose of this section is to provide informa tion; tion to licensees and applicants regarding the use of For teletherapy: the total dose, dose per frac this regulatory guide by the NRC staff.

tion, treatment site, and overall treatment period;

This guide was published for public comment to For high-dose-rate remote afterloading brachy encourage public participation in its development. The therapy: the radioisotope, treatment site, and to public comments were used in the development of this tal dose; final regulatory guide. Except in those cases in which a

• For all other brachytherapy prior to implantation: licensee or an applicant proposes an acceptable alter the radioisotope, number of sources, and source native method for complying with specified portions of strengths; after implantation but prior to comple the NRC's regulations, this regulatory guide will be tion of the procedure: the radioisotope, treat used by the NRC staff in evaluating quality manage ment site, and total source strength and exposure ment programs for the administration of byproduct time (or, equivalently, total dose); material or radiation from byproduct material.

8.33-8

BIBLIOGRAPHY

American Association of Physicists in Medicine, "In Protection," Report No. 40, ICRU, Bethesda, Mary formation that Should Be Included in Every Patient's land, 1986.

Radiotherapy Treatment Record (External Beam),"

Radiological Physics Center, M. D. Anderson Hospital International Commission on Radiation Units and and Tumor Institute, Houston, Texas, 1985. Measurements, "Radiation Dosimetry: X-Rays and Gamma Rays with Maximum Photon Energies American Association of Physicists in Medicine, Between 0.6 and 50 MeV," Report No. 14, ICRU,

"Physical Aspects of Quality Assurance in Radiation Washington, DC, 1969.

Therapy," AAPM Report No. 13, American Institute Interstitial Collaborative Working Group (L.L. Ander of Physics, New York, 1984. son et al.), Interstitial Brachytherapy: Physical, Bio American Association of Physicists in Medicine, logical, and Clinical Considerations, Raven Press,

"Specification of Brachytherapy Source Strength," New York, 1990.

AAPM Report No. 21, American Institute of Physics, Johns, H.E., J.R. Cunningham, The Physics of Radi New York, 1987. ology, Charles C Thomas Publisher, Springfield, Illi American College of Medical Physics, "Radiation nois, 1983.

Control and Quality Assurance in Radiation Oncology; Joint Commission on Accreditation of Healthcare A Suggested Protocol," Report No. 2, ACMP, Louis Organizations, "Accreditation Manual for Hospitals,"

ville, Kentucky, 1986. JCAHO, Oakbrook Terrace, Illinois, 1990.

American College of Medical Physics, "Radiation Joint Commission on Accreditation of Healthcare Control and Quality Assurance Surveys-Nuclear Organizations, "The Joint Commission Guide to Qual Medicine; A Suggested Protocol," Report No. 3, ity Assurance," JCAHO, Chicago, 1988.

ACMP, Louisville, Kentucky, 1§86. Kramer, S., D. Herring, "The Patterns of Care Study:

American College of Nuclear Physicians, "Guidelines A Nationwide Evaluation of the Practice of Radiation for Quality Assurance in Nuclear Medicine Practice," Therapy in Cancer Management," InternationalJour Section III of ACNP Inspector's Manual, Publication nal of Radiation: Oncology-Biology-Physics, Vol.

No. 88-6, ACNP, Washington, DC, 1988. 1(11/12), pp. 1231-1236, 1976.

Moores, B.M., et al., Practical Guide *to Quality American College of Radiology, "ACR Standards for Assurance in Medical Imaging, John Wiley and Sons, Radiation Oncology," ACR, Reston, Virginia, 1990. Inc., New York, 1987.

American College of Radiology, "Physical Aspects of National Council on Radiation Protection and Meas Quality Assurance," ACR, Reston, Virginia, 1990. urements, "Protection Against Radiation from Brachytherapy Sources," Report No. 40, NCRP,

American College of Radiology, "Quality Assurance in Washington, DC, 1972.

Radiation Therapy, A Manual for Technologists,"

ACR, Chicago, 1982. "A Protocol for the Determination of Absorbed Dose from High-Energy Photon and Electron Beams,"

Diamond, J.J., G.E. Hanks, S. Kramer, "The Struc Medical Physics, Vol. 10(6), pp. 741-771, 1983.

ture of Radiation Oncology Practices in the Continen tal United States," InternationalJournalof Radiation: Rhodes, B.A., ed., Quality Control in Nuclear Medi Oncology-Biology-Physics, Vol. 14, pp. 547-548, cine, C.V. Mosby, St. Louis, 1977.

1988. Shalek, R.J., "Radiological Physics in a Cancer Center and Other Comments," in Frontiers of Radiation Eckelrnan, W.C., S.M. Levenson, "Chromatographic Therapy and Oncology, University Park Press, Balti Purity of Tc-99m Compounds," in B.A. Rhodes, ed., more, 1973.

Quality Control in Nuclear Medicine, pp. 197-209, C.V. Mosby, St. Louis, 1977. Society of Nuclear Medicine, Quality Assurance Re source Manual for Nuclear Medicine, SNM, New Gagnon, W.F., et al., "An Analysis of Discrepancies York, 1990.

Encountered by the AAPM Radiological Physics Cen ter," Medical Physics, Vol. 5(6), pp. 556-560, 1978. Starkschall, G., "Proceedings of a Symposium on Quality Assurance of Radiotherapy Equipment,"

Gilbert, S., et al., "Quality Assurance Resource Man American Association of Physicists in Medicine, Kan ual for Nuclear Medicine," Society of Nuclear Medi sas City, Missouri, 1982.

cine, New York, 1990. United States Nuclear Regulatory Commission, Golden, R., et al., "A Review of the Activities of the "Guide for the Preparation of Applications for Medi AAPM Radiological Physics Center in Interinstitu cal Use Programs," Regulatory Guide 10.8, Revision tional Trials Involving Radiation Therapy," Cancer, 2, Washington, DC, August 1987.

Vol. 29(6), pp. 1468-1472, 1972. World Health Organization, "Quality Assurance in Radiation Therapy: Proceedings of a Workshop Gray, J.E., Quality Control in Diagnostic Imaging, Aspen Publishers, Inc., Rockville,- Maryland, 1983. December 2-7, .1984 at Schloss Reisenburg," WHO,

Geneva, 1988.

International Commission on Radiation Units and World Health Organization, "Quality Assurance in Measurements, "The Quality Factor in Radiation Nuclear Medicine," WHO, Geneva, 1982.

8.33-9

REGULATORY ANALYSIS

A separate regulatory analysis was not prepared ines the cost and benefits of the rule as implemented for this regulatory guide. The regulatory analysis pre using the guide. A copy of the regulatory analysis is pared for the amendment, "Quality Management Pro available for inspection and copying for a fee at the gram and Misadministrations," to 10 CFR Part 35 NRC Public Document Room, 2120 L Street, NW.,

provides the regulatory basis for this guide and exam- Washington, DC.

8.33-10

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