Regulatory Guide 8.33

(Task DG-8001), Quality Management Program

ML003739489
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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

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 staff In evaluating specific problems o. postulated accidents, or to pro vide guidance to applicants. Regulatory Guides are not substitutes for regulations, and compliance with them is not required. Methods and solutions different from those set out In the guides will be acceptable If they provide a basis for the findings requisite to the issuance or continu ance of a permit or license by the Commission.

This guide was Issued after consideration of comments received from the public, Comments and suggestions for Improvements In these guides are encouraged at all times, and guides will be revised, as ap propriate, to accommodate comments and to reflect new Information or experience.

Written comments may be submitted to the Regulatory Publications Branch, DFIPS, ARM, U.S. Nuclear Regulatory Commission, Washing ton, DC 20555.

The guides are issued in the following ten broad divisions:

6. Products

2. Research and Test Reactors

7. Transportation

3. Fuels and Materials Facilities

8. Occupational Health

4. Environmental and Siting

9. Antitrust and Financial Review

5. Materials and Plant Protection

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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

According to § 35.32, "Quality Management Pro gram,"

of

10 CFR Part 35,

"Medical Use of Byproduct Material," applicants or licensees, as appli cable, are required to establish a quality management (QM) program. This regulatory guide provides guid ance to licensees and applicants for developing poli cies and procedures for the QM program. This guide does not restrict or limit the licensee from using other guidance that may be equally useful in developing a QM program, e.g., information available from the Joint Commission on Accreditation of Healthcare Organizations or the American College of Radiology.

Any information collection activities mentioned in this regulatory guide are contained as requirements in 10 CFR Part 35, which provides the regulatory basis for this guide. The information collection require ments in 10 CFR Part 35 have been cleared under OMB Clearance No. 3150-0010.

B. DISCUSSION

The administration of byproduct material can be a complex process for many types of diagnostic and therapeutic procedures in nuclear medicine or oncol ogy departments. A number of individuals may be involved in the delivery process. For example, in an oncology department when th6 authorized user pre scribes a teletherapy treatment, the delivery process may involve a team of medical professionals such as a radiation therapy physicist, dosimetrist, and radiation therapy technologist. Conducting the plan of treat ment may involve a number of measurements, calcula tions, computer-generated treatment plans, patient simulations, portal film verifications, and beam modifying devices to deliver the prescribed dose.

Therefore, instructions must be clearly communicated to the professional team members with constant atten tion devoted to detail during the treatment process.

Complicated processes of this nature require good planning and clear, understandable procedures.

The administration of byproduct material or radia tion from byproduct material can involve a number of treatment modlities, e.g., radiopharmaceutical ther apy, teletherapy, brachytherapy, or gamma stereotac tic radiosurgery. For each modality, this regulatory guide recommends specific policies or procedures to ensure that the objectives of 10 CFR 35.32 are met.

In general, this guide recommends that licensees have:

Policies to have an authorized user date and sign a written directive prior to the administration, Procedures to identify the patient by more than one method, Procedures to be sure the plans of treatment are in accordance with the written directive,

"

Procedures to confirm that, prior to administra tion, the person responsible for the treatment modality will check the specific details of the written directive (e.g., in radiopharmaceutical therapy, verify the radiopharmaceutical, dosage, and route of administration; or in oncology, ver ify the treatment site, total dose, dose per frac tion, and overall treatment period),

"

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

C. REGULATORY POSITION

This regulatory guide provides guidance to licen sees and applicants for developing a quality manage ment program acceptable to the NRC staff for comply ing with 10 CFR 35.32. However, a licensee or applicant may use other sources of guidance and experience in addition to or in lieu of this regulatory guide. The NRC staff would review such a program on a case-by-case basis.

The licensee's QM program should contain the.

essential elements of the policies and procedures listed in the following sections.

1.

SUGGESTED POLICIES AND

PROCEDURES FOR CERTAIN

RADIOPHARMACEUTICAL USES

1.1. The licensee should establish a policy to have an authorized user date and sign a written directive prior to the administration of any therapeutic dosage of a radiopharmaceutical or any dosage of quantities greater than 30 microcuries of either sodium iodide 1-125 or 1-131. A written directive is required by 10 CFR 35.32(a) (1). Procedures for oral directives and revisions to written directives are contained in Regulatory Position 5.

1.2. Before administering a radiopharmaceutical dosage, the licensee should establish a procedure to verify by more than one method the identity of the patient as the individual named in the written direc tive. Identifying the patient by more than one method is required by 10 CFR 35.32(a) (2). The procedure used to identify the patient should be to ask the patient's name and confirm the name and at least one of the following by comparison with corresponding information in the patient's record: birth date, ad dress, social security number, signature, the name on the patient's ID bracelet or hospital ID card, or the name on the patient's medical insurance card.

1.3. The licensee should establish a procedure to verify, before administering the byproduct mate rial, that the specific details of the administration are in accordance with the written directive. The radio pharmaceutical, dosage, and route of administration should be confirmed by the person administering the radiopharmaceutical to verify agreement with the writ-

8.33-1

ten directive, that is, the dosage should be measured in the dose calibrator and the results compared with the prescribed dosage in the written directive.

1.4. The licensee should establish a policy for all workers to seek guidance if they do not understand how to carry out the written directive. That is, workers should ask if they have any questions about what to do or how it should be done rather than continuing a procedure when there is any doubt.

1.5. The licensee should establish a procedure to have an authorized user or a qualified person under the supervision of an authorized user (e.g., a nuclear medicine physician, physicist, or technolo gist),

after administering a

radiopharmaceutical, make, date, and sign or initial a written record that documents the administered dosage in the patient's chart or other appropriate record. The responsibilities and conditions of supervision are contained in 10 CFR

35.25. A record of the administered dosage is re quired by 10 CFR 35.32(d)(2).

1.6. The licensee should establish procedures to perform periodic reviews of the radiopharmaceutical QM program. Guidance. on periodic reviews is pro vided in Regulatory Position 6. A QM program review is required by 10 CFR 35.32(b).

2.

SUGGESTED POLICIES AND

PROCEDURES FOR TELETHERAPY

2.1. The licensee should establish a policy to have an authorized user date and sign a written directive prior to the administration of any teletherapy dose. A written directive is required by 10 CFR

35.32(a) (1). Procedures for oral directives and revi sions to written directives are contained in Regulatory Position 5.

2.2. Before administering a teletherapy dose, the licensee should establish a procedure to verify by more than one method the identity of the patient as the individual named in the written directive. Identify ing the'patient by more than one method is required by 10 CFR 35.32(a)(2). The procedure used to identify the patient should be to ask the patient's name and confirm the name and at least one of the following by comparison with the corresponding infor nation in the patient's record: 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, or the photo graph of the patient's face.

2.3. The licensee should establish a policy to have an authorized user approve a plan of treatment that provides sufficient information and direction to meet the objectives of the written directive. Suggested guidelines for information to be included in the plan of treatment may be obtained from the American College of Radiology.

2.4. The licensee should establish a procedure to verify, before administering each teletherapy dose, that the specific details of the administration are in accordance with the written directive and plan of treatment. In .particular, the treatment site and the dose per fraction should be confirmed by the person administering the teletherapy treatment to verify agreement with the written directive and plan of treatment.

2.5. The licensee should establish a policy for all workers to seek guidance if they do not understand how to carry out the written directive. That is, workers should ask if they have any questions about what to do or how it should be done rather than continuing a procedure when there is any doubt.

2.6. The licensee should establish a procedure to have a qualified person under the supervision of an authorized user (e.g., an oncology physician, radiation therapy physicist, dosimetrist, or radiation therapy technologist), after administering a teletherapy dose fraction, make, date, and sign or initial a written record in the patient's chart or in another appropriate record that contains, for each treatment field, the treatment time, dose administered, and the cumula tive dose administered. The responsibilities and condi tions of supervision are contained in 10 CFR 35.25. A

record of the administered dose is required by 10 CFR

35.32(d) (2).

2.7. The licensee should establish a procedure to have a weekly chart check performed by a qualified person under the supervision of an authorized user (e.g., a radiation therapy physicist, dosimetrist, oncol ogy physician, or radiation therapy technologist) to detect mistakes (e.g., arithmetic errors, miscalcula tions, or incorrect transfer of data) that may have occurred in the daily and cumulative teletherapy dose administrations from all treatment fields or in connec tion with any changes in the written directive or plan of treatment. The responsibilities and conditions of supervision are contained in 10 CFR 35.25.

2.8. If the prescribed dose is to be administered in more than three fractions, the licensee should establish a procedure to check the dose calculations within three working days after administering the first teletherapy fractional dose. An authorized user or a qualified person under the supervision of an author ized user (e.g., a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technolo gist), who whenever possible did not make the original calculations, should check the dose calculations. If the prescribed dose is to be administered in three frac tions or less, a procedure for checking dose calcula tions as described in this paragraph should be per formed before administering the first teletherapy

8.33-2

fractional dose. The responsibilities and conditions of supervision are contained in 10 CFR 35.32.

Manual dose calculations should be checked for:

(1)

Arithmetic errors,

(2)

Appropriate transfer of data from the writ ten directive, plan of treatment, tables, and graphs,

(3)

Appropriate use of nomograms (when ap plicable), and

(4)

Appropriate use of all pertinent data in the calculations.

Computer-generated dose calculations should be checked by examining the computer printout to verify that the correct data for the patient were used in the calculations (e.g., patient contour, patient thickness at the central ray, depth of target, depth dose factors, treatment distance, portal arrangement, field sizes, or beam-modifying factors).

Alternatively, the dose should be manually calculated to a single key point and the results compared to the computer-generated dose calculations.

If the manual dose calculations are performed using computer-generated outputs or vice versa, par ticular emphasis should be placed on verifying the correct output from one type of dose calculation (e.g.,

computer) to be used as an input in another type of dose calculation (e.g., manual). Parameters such as the transmission factors for wedges and the source strength of the sealed source used in the dose calcula tions should be checked.

2.9. The licensee should establish a procedure for independently checking certain full calibration measurements as follows:

After full calibration measurements that resulted from replacement of the source, or whenever spot check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full calibration corrected mathematically for radioactive decay, an independent check of the out put for a single specified set of exposure conditions should be performed. The independent check should be performed within 30 days following such full cali bration measurements.

The independent check should be performed by either:

(1)

An individual who did not perform the full calibration (the individual should meet the require ments specified in 10 CFR 35.961) using a dosimetry system other than the one that was used during the full calibration (the dosimetry system should meet the requirements specified in 10 CFR 35.630(a)), or

(2)

A teletherapy physicist (or an oncology physician, dosimetrist, or radiation therapy technolo gist who has been properly instructed) using a ther moluminescence dosimetry service available by mail that is designed for confirming teletherapy doses and that is accurate within 5 percent.

2.10. The licensee should establish a procedure to have full calibration measurements (required by 10

CFR 35.632) include the determination of transmis sion factors for trays and wedges. Transmission factors for other beam-modifying devices (e.g., nonrecastable blocks, recastable block material, bolus and compen sator materials, and split-beam blocking devices)

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

2.11. The licensee should establish a procedure to have a physical measurement of the teletherapy output made under applicable conditions prior to administration of the first teletherapy fractional dose if the patient's plan of treatment includes (1) field sizes or treatment distances that fall outside the range of those measured in the most recent full calibration or

(2) transmission factors for beam-modifying devices (except nonrecastable and recastable blocks, bolus and compensator materials, and split-beam blocking devices) not measured in the most recent full calibra tion measurement.

2.12. If the authorized user determines that de laying treatment to perform the checks of (1) dose calculations for a prescribed dose that is administered in three fractions or less (see Regulatory Position 2.8)

or (2) teletherapy output (see Regulatory Position

2.11) would jeopardize the patient's health because of the emergent nature of the patient's medical condi tion, the prescribed treatment may be provided with out first performing the checks of dose calculations or physical measurements. The authorized user should make a notation of this determination in the records of the calculated administered dose. The checks of the calculations should be performed within two work ing days of completion of the treatment.

2.13. The licensee should establish a procedure for performing acceptance testing by a qualified person (e.g., a teletherapy physicist) on each treat ment planning or dose. calculating computer program that could be used for teletherapy dose calculations.

Acceptance testing should be performed before the first use of a treatment planning or dose calculating computer program for teletherapy dose calculations.

Acceptance testing should also be performed after full calibration measurements when the calibration was performed (1) before the first medical use of the teletherapy unit, (2) after replacement of the source, or (3) when spot-check measurements indicated that the output differed by more than 5 percent from the output obtained at the last full calibration corrected

8.33-3

mathematically for radioactive decay. Computer generated beam data should be compared to meas ured beam data from the teletherapy unit. The licen see should assess each treatment planning or dose calculating computer program based on the licensee's specific needs and applications.

2.14 The licensee should establish procedures to perform periodic reviews of the teletherapy QM

program. Guidance on periodic reviews is provided in Regulatory Position 6. A QM program review is re quired by 10 CFR 35.32(b).

3.

SUGGESTED POLICIES AND

PROCEDURES FOR BRACHYTHERAPY

3.1 High-Dose-Rate Remote Afterloading Devices Similar licensee policies and procedures for low and medium-dose-rate remote afterloading devices would be equally helpful.

3.1.1.

The licensee should establish a policy to have an authorized user date and sign a written directive prior to the administration of any brachytherapy dose from a high-dose-rate remote afterloading device. A written directive is required by

10 CFR 35.32(a)(1). Procedures for oral directives and revisions to written directives are contained in Regulatory Position 5.

3.1.2. Before administering a brachytherapy treatment, the licensee should establish a procedure to verify by more than one method the identity of the patient as the individual named in the written direc tive. Identifying the patient by more than one method is required by 10.CFR 35.32(a)(2). The procedure used to identify the patient should be to ask the patient's name and confirm the name and at least one of the following by comparison with the corresponding information in the patient's record: birth date, ad dress, 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, or the photo graph of the patient's face.

3.1.3.

The licensee should establish a proce dure to verify, before administering the brachytherapy dose, that the specific details of the brachytherapy administration are in accordance with the written directive and plan of treAtment. The prescribed radio isotope, treatment site, and total dose should be confirmed by the person administering the brachytherapy treatment to verify agreement with the written directive and plan of treatment.

3.1.4. The licensee should establish a policy for all workers to seek guidance if they do not understand how to carry out the written directive. That is, workers should ask if they have any questions about what to do or how it should be done rather than continuing a procedure when there is any doubt.

3.1.5. The licensee should establish a proce dure for using radiographs or other comparable images (e.g., computerized tomography) as the basis for verifying the position of the nonradioactive "dummy"

sources and calculating the administered brachytherapy dose before inserting the sealed sources.

3.1.6. The licensee should establish a proce dure to check the dose calculations before administer ing the prescribed brachytherapy dose. An authorized user or a qualified person under the supervision of an authorized user (e.g., a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technologist), who whenever possible did not make the original calculations, should check the dose calcu lations. The responsibilities and conditions of "super vision" are contained in 10 CFR 35.25. Suggested methods for checking the calculations include the following:

"

Computer-generated dose calculations should be checked by examining the computer printout to verify that correct input data for the patient were used in the calculations (e.g., source strength and positions).

"*

The computer-generated dose calculations for in put into the brachytherapy afterloading device should be checked to verify correct transfer of data from the computer (e.g., channel numbers, source positions, and treatment times).

3.1.7. The licensee should establish a proce dure to have an authorized user, after administering the brachytherapy treatment, date and sign or initial a written record of the calculated administered dose in the patient's chart or in another appropriate record. A

record of the administered dose is required by 10 CFR

35.32(d) (2).

3.1.8.

If the authorized user determines that delaying treatment in order to perform the checks of dose calculations (see Regulatory Position 3.1.6)

would jeopardize the patient's health because of the emergent nature of the patient's medical condition, the checks of the calculations should be performed within two working days of the treatment.

3.1.9. The licensee should establish a proce dure for performing acceptance testing by a qualified person (e.`g., a teletherapy physicist) on each treat ment planning or dose calculating computer program that could be used for brachytherapy dose calculations when using high-dose-rate remote afterloading de vices. Acceptance testing should be performed before the first use of a treatment planning or dose cFlculat

• The term sealed sources includes wires and encapsulated sources.

8.33-4

ing computer program for brachytherapy dose calcula tions when using high-dose-rate remote afterloading devices. The licensee should assess each treatment planning or dose calculating computer program based on the licensee's specific needs and applications.

3.1.10. The licensee should establish proce dures to perform periodic reviews of the brachytherapy QM program for using the high-dose-rate remote after loading device. Guidance on periodic reviews is provided in Regulatory Position 6. A QM program review is re quired by 10 CFR 35.32(b).

3.2. All Other Brachytherapy Applications

3.2.1. The licensee should establish a policy to have an authorized user date and sign a written directive prior to the administration of any brachytherapy dose. A written directive is required by

10 CFR 35.32(a)(1). Procedures for oral directives and revisions to written directives are contained in Regulatory Position 5.

3.2.2. Before administering a brachytherapy dose, the licensee should establish a procedure to verify by more than one method the identity of the patient as the individual named in the written direc tive. Identifying the patient by more than one method is required by 10 CFR 35.32(a)(2). The procedure used to identify the patient should be to ask the patient's name and confirm the name and at least one of the following by comparison with the corresponding information in the patient's record: birth date, ad dress, 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, or the photo graph of the patient's face.

3.2.3. The licensee should establish a proce dure to verify, before administering the brachytherapy dose, that the specific details of the brachytherapy administration are in accordance with the written directive and plan of treatment. In particular, the radioisotope, number of sources, and source strengths should be confirmed to verify agreement with the written directive and plan of treatment.

3.2.4. The licensee should establish a policy for all workers to seek guidance if they do not understand how to carry out the written directive. That is, workers should ask if they have any questions about what to do or how it should be done rather than continuing a procedure when there is any doubt.

3.2.5. The licensee should establish a proce dure to have an authorized user or a qualified person under the supervision of an authorized user (e.g., a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technologist) verify that the radioisotope, number of sources, source strengths, and, if applicable, loading sequence of the sources to be used are in agreement with the written directive and plan of treatment before implanting the radioactive sealed sources.* The licensee may use any appropriate verification method, such as checking the serial number of the sealed sources behind an appro priate shield, using a radiation detector, using a dose calibrator, using color-coded sealed sources, or using clearly marked storage locations, i.e., one location for each source strength. The responsibilities and condi tions of supervision are contained in 10 CFR 35.25.

3.2.6. For temporary brachytherapy implants, the licensee should establish a procedure for using radiographs or other comparable images (e.g., com puterized tomography) of brachytherapy radioactive sources or nonradioactive "dummy" sources in place as the basis for verifying the position of the sources and calculating the exposure time (or, equivalently, the total dose). Whenever possible, nonradioactive

"dummy" sources should be used before inserting the radioactive sources (e.g., cesium-137 sealed sources used for intracavitary applications). However, some brachytherapy procedures may require the use of various fixed geometry applicators (e.g., appliances or templates) to establish the location of the temporary sources and calculate the exposure time (or, equiv alently, the total dose) required to administer the prescribed brachytherapy treatment. In these cases, radiographs or other comparable images may not be necessary provided the position of the sources is known prior to inserting the radioactive sources and calculating the exposure time (or, equivalently, the total dose).

3.2.7. For permanent brachytherapy implants, the licensee should establish a procedure for using radiographs or other comparable images (e.g.,

computerized tomography) of brachytherapy radioac tive sources in place as the basis for verifying the'

position of the sources and calculating the total dose, if applicable, after inserting the sources (e.g.,

iodine-125 sealed sources used for interstitial applica tions). However, some brachytherapy procedures may require the use of various fixed geometry applicators (e.g., templates) to establish the location of the sources and calculate the total dose, if applicable. In these cases, radiographs or other comparable'images may not be necessary.

3.2.8. After insertion of the temporary implant brachytherapy sources (see Regulatory Position

3.2.6), the licensee should establish a procedure to have an authorized user promptly record the actual loading sequence of the radioactive sources implanted (e.g., location of each sealed source in a tube, tandem, or cylinder) and sign or initial the patient's chart or other appropriate record.

3.2.9. After insertion of the permanent implant brachytherapy sources (see Regulatory Position

• The term sealed sources includes wires and encapsulated sources.

8.33-5

3.2.7), the licensee should establish a procedure to have an authorized user promptly record the actual number of radioactive sources implanted and sign or initial the patient's chart or other appropriate record.

3.2.10. The licensee should establish a proce dure to check the dose calculations before the total prescribed brachytherapy dose has been administered.

An authorized user or a qualified person under the supervision of an authorized user (e.g., a radiation therapy physicist, oncology physician, dosimetrist, or radiation therapy technologist), who whenever. possi ble did not make the original calculations, should check the dose calculations. The responsibilities and conditions of supervision are contained in 10 CFR

35.25. Manual dose calculations should be checked for:

"*

Arithmetic errors,

"*

Appropriate transfer of data from the written di rective, plan of treatment, tables, and graphs,

"*

Appropriate use of nomograms (when applica ble), and

"*

Appropriate use of all pertinent data in the calcu lations.

Computer-generated dose calculations should be checked by examining the computer printout to verify that the correct data for the patient were used i' the calculations (e.g., position of the applicator or sealed sources, number of sources, total source strength, or source loading sequence).

Alternatively, the brachytherapy dose should be manually calculated to a single key point and the results compared to the computer-generated dose calculations. If the manual dose calculations are performed using computer generated outputs (or vice versa), particular emphasis should be placed on verifying the correct output from one type of calculation (e.g., computer) to be used as an input in another type of calculation (e.g., manual).

3.2.11. The licensee should establish a proce dure to have an authorized user date and sign or initial a written record in the patient's chart or in another

.appropriate record after insertion of the brachytherapy sources but prior to completion of the procedure. The written record should include the radioisotope, treatment site, and total source strength and exposure time (or, equivalently, the total dose).

A record of the administered dose (or, equivalently, the total source strength and exposure time) is re quired by 10 CFR 35.32(d)(2).

3.2.12. If the authorized user determines that delaying treatment in order to perform the checks of dose calculations (see Regulatory Position 3.2.10)

would jeopardize the patient's health because of the emergent nature of the patient's medical condition, the checks of the calculations should be performed within two working days of completion of the brachytherapy treatment.

3.2.13. The licensee should establish a proce dure for performing acceptance testing by a qualified person (e.g., a teletherapy physicist) on each treat ment planning or dose calculating computer program that could be used for brachytherapy dose calcula tions. Acceptance testing should be performed before the first use of a treatment planning or dose calculat ing computer program for brachytherapy dose calcula tions. The licensee should assess each treatment plan ning or dose calculating computer program based on the licensee's specific needs and applications.

3.2.14. The licensee should establish procedures to perform periodic reviews of the brachytherapy QM

program. Guidance on periodic reviews is provided in Regulatory Position 6. A QM program review is re quired by 10 CFR 35.32(b).

4.

SUGGESTED POLICIES AND

PROCEDURES FOR GAMMA

STEREOTACTIC RADIOSURGERY

4.1. The licensee should establish a policy to have an authorized user date and sign a written directive before administering treatment. A written directive is required by 10 CFR 35.32(a)(1). Proce dures for oral directives and revisions to written directives are contained in Regulatory Position 5.

4.2. Before administering treatment, the licen see should establish a procedure .to verify by more than one method the identity of the patient as the individual named in the written directive. Identifying the patient by more than one method is required by

10 CFR 35.32(a)(2). The procedure used to identify the patient should be to ask the patient's name and confirm the name and at least one of the following by comparison with the corresponding information in the patient's record: 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, or the photograph of the patient's face.

4.3. The licensee should establish a procedure to have the neurosurgeon, the oncology physician, and the radiation therapy, physicist date and sign a plan of treatment that includes, for each targit point, the coordinates, the plug pattern, the collimator size, the exposure time, the target dose, and the total dose before administering treatment.

4.4. The licensee should establish a policy for all workers to seek guidance if they do not understand how to carry out the written directive. That is, workers should ask if they have any questions about what to do or how it should be done rather than continuing a procedure when there is any doubt.

8.33-6

4.5. The licensee should establish a procedure to verify, before administering each treatment, that he specific details of the administration are in accor dance with the written directive and plan of treatment.

The verification should be performed by at least one qualified person (e.g., an oncology physician, radia tion therapy physicist, or radiation therapy technolo gist) other than the individuals who dated and signed the written directive and plan of treatment. Particular emphasis should be directed toward verifying that the stereotactic frame coordinates on the patient's skull match those of the plan of treatment.

4.6. The licensee should establish a procedure to check computer-generated dose calculations by examining the computer printout to verify that correct data for the patient were used in the calculations.

4.7. The licensee should establish a procedure to check that the computer-generated dose calcula tions were correctly input to the gamma stereotactic radiosurgery unit.

4.8. The licensee should establish a procedure to have the neurosurgeon or the oncology physician, after administering the treatment, date and sign or initial a written record of the calculated administered dose in the patient's chart or in another appropriate record. A record of the administered dose is required by 10 CFR 35.32(d)(2).

4.9. If the authorized user determines that de laying treatment in order to perform the checks of the dose calculations (see Regulatory Positions 4.6 and

4.7) would jeopardize the patient's health because of the emergent nature of the patient's medical condi tion, the checks of the calculations should be per formed within two working days of the treatment.

4.10. The licensee should establish a procedure for performing acceptance testing by a qualified person (e.g., a teletherapy physicist) on each treat ment planning or dose calculating computer program that could be used for gamma stereotactic radiosur gery dose calculations. Acceptance testing should be performed before the first use of a treatment planning or dose calculating computer program for gamma stereotactic radiosurgery dose calculations. The licen see should assess each treatment planning or dose calculating computer program based on the licensee's specific needs and applications.

4.11. The licensee should establish procedures to perform periodic reviews of the gamma stereotactic radiosurgery QM program. Guidance on periodic re views is provided in Regulatory Position

6. A QM

program review is required by 10 CFR 35.32(b).

5.

ORAL DIRECTIVES AND REVISIONS TO

WRITTEN DIRECTIVES

A footnote to 10 CFR 35.32(a)(1) reads as fol lows:

"If, because of the patient's medical condi tion, a delay in order to provide a written revision to an existing written directive would jeopardize 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 a revised written directive is dated and signed by the authorized user within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> 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 by an authorized user prior to the administration of the radiopharmaceutical dosage, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the teletherapy dose, or the next teletherapy fractional dose.

"If, because of the emergent nature of the patient's medical condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be accept able, provided that the information contained in the oral directive is documented immediately in 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."

6.

PERIODIC REVIEWS

The licensee should establish written procedures to conduct periodic reviews of each applicable pro gram area, e.g., radiopharmaceuticals, teletherapy, brachytherapy, and gamma stereotactic radiosurgery.

The review should include, from the previous 12 months (or since the last review), a representative sample of patient administrations, all recordable events, and all misadministrations. The number of patient cases to be sampled should be based on the principles of statistical acceptance sampling and should represent each treatment modality performed in the institution, e.g.,

radiopharmaceutical, teletherapy, brachytherapy, and gamma stereotactic radiosurgery. For example, using the acceptance sam pling tables of 10 CFR 32.110 and assuming an error rate (or lot tolerance percent defective) of 2 percent, the number of patient cases to be reviewed (e.g., 115)

based on 1000 patients treated would be larger than the number of patient cases to be reviewed (e.g., 85)

based on 200 patients treated. In order to eliminate any bias in the sample, the patient cases to be reviewed should be selected randomly. For each pa tient's case, a comparison should be made between what was administered versus what was prescribed in the written directive. If the difference between what

8.33-7

was administered and what was prescribed exceeds the criteria for either a recordable event or a misadmin istration, that comparison is unacceptable. The num ber of "unacceptable comparisons" that is allowed for each sample size and lot tolerance percent defective is provided in the acceptance sampling tables of 10 CFR

32.110.

These periodic reviews could be conducted weekly, monthly, or quarterly if one of these periods is more compatible with the licensee's operations.

If feasible, the persons conducting the review should not review their own work. If this is not possible, two people should work together as a team to conduct the review of that work. The licensee or designee should regularly review the findings of the periodic reviews to ensure that the QM program is effective.

For each patient case reviewed, the licensee should determine whether the administered radio pharmaceutical dosage or radiation dose was in accor dance with the written directive or plan of treatment, as applicable. For example, were the following cor rect:

For radiopharmaceutical therapy:

the radio pharmaceutical, dosage, and route of administra tion;

For teletherapy: the total dose, dose per frac tion, treatment site, and overall treatment period;

For high-dose-rate remote afterloading brachy therapy: the radioisotope, treatment site, and to tal dose;

For all other brachytherapy prior to implantation:

the radioisotope, number of sources, and source strengths; after implantation but prior to comple tion of the procedure:

the radioisotope, treat ment site, and total source strength and exposure time (or, equivalently, total dose);

For gamma stereotactic radiosurgery: target co ordinates, collimator size, plug pattern, and total dose.

For each patient case reviewed, the licensee should identify deviations from the written directive, the cause of each deviation, and the action required to prevent recurrence. The actions may include new or revised policies, new or revised procedures, addi tional training, or increased supervisory review of work.

The licensee should reevaluate the QM program's policies and procedures after each annual review to determine whether the program is still effective or to identify actions required to make the program more effective.

Program review results should be documented and should be available for NRC inspectors. To obtain the maximum results from the lessons learned from each review, the program review reports should be distrib uted within the institution to appropriate management and departments. Corrective actions for deficient con ditions should be implemented within a reasonable time after identification of the deficiency.

D. IMPLEMENTATION

The purpose of this section is to provide informa tion to licensees and applicants regarding the use of this regulatory guide by the NRC staff.

This guide was published for public comment to encourage public participation in its development. The public comments were used in the development of this final regulatory guide. Except in those cases in which a licensee or an applicant proposes an acceptable alter native method for complying with specified portions of the NRC's regulations, this regulatory guide will be used by the NRC staff in evaluating quality manage ment programs for the administration of byproduct material or radiation from byproduct material.

8.33-8

BIBLIOGRAPHY

American Association of Physicists in Medicine, "In formation that Should Be Included in Every Patient's Radiotherapy Treatment Record (External Beam),"

Radiological Physics Center, M. D. Anderson Hospital and Tumor Institute, Houston, Texas, 1985.

American Association of Physicists in Medicine,

"Physical Aspects of Quality Assurance in Radiation Therapy," AAPM Report No. 13, American Institute of Physics, New York, 1984.

American Association of Physicists in Medicine,

"Specification of Brachytherapy Source Strength,"

AAPM Report No. 21, American Institute of Physics, New York, 1987.

American College of Medical Physics, "Radiation Control and Quality Assurance in Radiation Oncology;

A Suggested Protocol," Report No. 2, ACMP, Louis ville, Kentucky, 1986.

American College of Medical Physics, "Radiation Control and Quality Assurance Surveys-Nuclear Medicine; A Suggested Protocol," Report No. 3, ACMP, Louisville, Kentucky, 1§86.

American College of Nuclear Physicians, "Guidelines for Quality Assurance in Nuclear Medicine Practice,"

Section III of ACNP Inspector's Manual, Publication No. 88-6, ACNP, Washington, DC, 1988.

American College of Radiology, "ACR Standards for Radiation Oncology," ACR, Reston, Virginia, 1990.

American College of Radiology, "Physical Aspects of Quality Assurance," ACR, Reston, Virginia, 1990.

American College of Radiology, "Quality Assurance in Radiation Therapy, A Manual for Technologists,"

ACR, Chicago, 1982.

Diamond, J.J., G.E. Hanks, S. Kramer, "The Struc ture of Radiation Oncology Practices in the Continen tal United States," International Journal of Radiation:

Oncology-Biology-Physics, Vol.

14, pp. 547-548,

1988.

Eckelrnan, W.C., S.M. Levenson, "Chromatographic Purity of Tc-99m Compounds," in B.A. Rhodes, ed.,

Quality Control in Nuclear Medicine, pp. 197-209, C.V. Mosby, St. Louis, 1977.

Gagnon, W.F., et al., "An Analysis of Discrepancies Encountered by the AAPM Radiological Physics Cen ter," Medical Physics, Vol. 5(6), pp. 556-560, 1978.

Gilbert, S., et al., "Quality Assurance Resource Man ual for Nuclear Medicine," Society of Nuclear Medi cine, New York, 1990.

Golden, R., et al., "A Review of the Activities of the AAPM Radiological Physics Center in Interinstitu tional Trials Involving Radiation Therapy," Cancer, Vol. 29(6), pp. 1468-1472, 1972.

Gray, J.E., Quality Control in Diagnostic Imaging, Aspen Publishers, Inc., Rockville,- Maryland, 1983.

International Commission on Radiation Units and Measurements, "The Quality Factor in Radiation Protection," Report No. 40, ICRU, Bethesda, Mary land, 1986.

International Commission on Radiation Units and Measurements, "Radiation Dosimetry: X-Rays and Gamma Rays with Maximum Photon Energies Between 0.6 and 50 MeV," Report No. 14, ICRU,

Washington, DC, 1969.

Interstitial Collaborative Working Group (L.L. Ander son et al.), Interstitial Brachytherapy: Physical, Bio logical, and Clinical Considerations, Raven Press, New York, 1990.

Johns, H.E., J.R. Cunningham, The Physics of Radi ology, Charles C Thomas Publisher, Springfield, Illi nois, 1983.

Joint Commission on Accreditation of Healthcare Organizations, "Accreditation Manual for Hospitals,"

JCAHO, Oakbrook Terrace, Illinois, 1990.

Joint Commission on Accreditation of Healthcare Organizations, "The Joint Commission Guide to Qual ity Assurance," JCAHO, Chicago, 1988.

Kramer, S., D. Herring, "The Patterns of Care Study:

A Nationwide Evaluation of the Practice of Radiation Therapy in Cancer Management," International Jour nal of Radiation: Oncology-Biology-Physics, Vol.

1(11/12), pp. 1231-1236, 1976.

Moores, B.M., et al., Practical Guide *to Quality Assurance in Medical Imaging, John Wiley and Sons, Inc., New York, 1987.

National Council on Radiation Protection and Meas urements,

"Protection Against Radiation from Brachytherapy Sources,"

Report No. 40, NCRP,

Washington, DC, 1972.

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

Medical Physics, Vol. 10(6), pp. 741-771, 1983.

Rhodes, B.A., ed., Quality Control in Nuclear Medi cine, C.V. Mosby, St. Louis,

1977.

Shalek, R.J., "Radiological Physics in a Cancer Center and Other Comments," in Frontiers of Radiation Therapy and Oncology, University Park Press, Balti more, 1973.

Society of Nuclear Medicine, Quality Assurance Re source Manual for Nuclear Medicine, SNM, New York, 1990.

Starkschall, G., "Proceedings of a Symposium on Quality Assurance of Radiotherapy Equipment,"

American Association of Physicists in Medicine, Kan sas City, Missouri, 1982.

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"Guide for the Preparation of Applications for Medi cal Use Programs," Regulatory Guide 10.8, Revision

2, Washington, DC, August 1987.

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Proceedings of a Workshop December 2-7, .1984 at Schloss Reisenburg," WHO,

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8.33-9

REGULATORY ANALYSIS

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

Washington, DC.

8.33-10

.

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