ML20210R737

Working Draft Entitled, Teletherapy, as Part of NRC Program to Revise 10CFR35 & Associated Guidance Documents

ML20210R737
Person / Time
Issue date:	08/07/1997
From:	NRC
To:
Shared Package
ML20210K626	List: ML20210K620 ML20210R737 ML20210R742 ML20210R752 ML20210R759 ML20210R770 ML20210R775
References
FRN-62FR42219, RULE-PR-35 PROC-970807, NUDOCS 9709030243
Download: ML20210R737 (26)

Text

._ . _ _

0 0 August 7,1997 WORKING DRAFT TELETHERAPY

, NOTE Following Commission approval of the staffs program to revise 10 CFR Part 35 and associated guidance documents, the NRC staff initiated development of draft rule language, using a modality based approach. These draft modalities are being provided to the Part 35 Working Group at a very early stage in their development because thuy are key to the discussion of significant issues associated with the regulation of the medical use of byproduct material, which is an agenda item at the August 19-20 meeting of the group. It should be noted that at this point in their development that they have not undergone a thorough review, including a review to ensure that they reflect the Commission's direction. In fact, in some cases, the draft documents contain diffc. cent alternatives to regulation of a specific area. Hopefully,

~

these differences will stimulate input and additional alternatives from the Working Group.

l-i I

9709030243 970810 PDR-- PR

! 35 62FR42219 PDR

s s STAFF LEVEL DRAFT DOCUMENT August 7,1997 -l 1

SECTIONS APPLYING TO TELETHERAPY PART 35-MEDICAL USE OF BYPRODUCT MATERIAL P R E FA C E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 G E N E RA L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Section 35.600 TELE Use of a sealed source in a teletherapy unit . . . . . . . . . . . . . . . . 3 Section 35.2 TELE Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Section 35.6 Provisions for research involving human subjects . . . . . . . . . . . . . . . . . , . C

. Section 35.7 FDA, other Federal, and State requirements . . . . . . . . . . . . . . . . . . . . . . 5 Section 35.999 TELE Resnlution of conflicting requirements during transition period . . 5 LIC E N SI N G P ROVI S!ON S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Section 35.11 TELE License required . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Section 35.12 TELE Application for license, amendment, or renewal . . . . . . . . . . . . . . 5 Section 35.18 TELE License issuance . . . . . . . . . . . . . . . . . . . . . . . . . . . ......... 6

,Section 35.13 TELE License amendments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Section 35. TELE 1 Authorization for depleted uranium . . . . . . . . . . . . . . . . . . . . . . . . . 7 Section 35.57 TELE Authorization for calibration and reference sources . . . , . . . . . 7 Section 35.14 TELE Personnel and address change notifications . . . . . . . . . . . . . . . . 7 Section 35.19 Specific exemptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 EQUIPMENT TELETHERAPY UNIT PROGRAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Section 35.620 TELE Possession, calibration and check of survey instruments . . . . . . 8 Section 35.630 TELE Dosimetry equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Section 35. TELE 2 Therapy related computer systems

................................ ............................. 9 RADIATION SAFETY REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Section 35.21 TELE Radiation Snfety Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Section 35.22 TELE Radiation Safety Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Sectior; 35.23 TELE Statements of authority and responsibilities . . . . . . . . . . . . . . . . . 10 Section 35.25 Supervision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Section 35.31 TELE Radiation safety program changes . . . . . . . . . . . . . . . . , . . . . . . 11 Section 35.32 TELE - Quality management program . . . . . . . . . . . . . . . . . . . . . . . . 11 Section 35.33 TELE Notifications, reports, and rece rds of reportable medical events .12 Section 35.59 TELE Requirements for possession of sealed aources . . . . . . . . . . . . . _12 Section 35.605 TELE Five-year inspection, maintenance repair, and disposal restrictions

.............................................................13 Section 35.610 TELE Safety instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

l e e l l

I i

l August 7,1997

- STAFF LEVEL DRAFT DOCUMENT _

Section 35.615 TELE Teletherapy room access control and patient observation . . . . . 14 -

15

35. TELE 3 Teletherapy room radiation monitor . . . . . . . . . . . . , , . . . . . . . . . . . . . . . .

15 l Section 35. TELE 4 Beam Q uality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15  :

lSection 35.632 TELE Full calibration measurements . . . . . . . . . . . . . . . . . . . . . . . . .

Section 35.634 TELE ~ Periodic spot checks . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Section 35.636 TELE Safety checks for teletherapy facilities . . . . . . . . . . . . . . . . . . . 17 Section 35.641 Radiation surveys for teletherapy facilities . . . . . . . . . . . . . . . . . . . . . 17 Section 35.643 Modification of teletherapy unit or room before beginning a treatment 13 p rog ra m . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

RECORDS.............................................................18 18 Section 35.5 Maintenance of records 7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Section 35.645 Reports of tetherapy surveys, checks, tests, and measurements , . . 22

, TRAI N I N G . . . . . . . . . . . . . . . . . . . . . . . . . . , . . ................................ 22 Section 35.900 Radiation Safety Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Section 35.901 Training for experienced Radiation Safety Officer . . . . . . . . . . . . . . . 23 Section 35.960 Training for teletherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Section 35.961 Training for teletherapy physicist . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Section 35.970 Training for experienced authorized users . . . . . . . . . . . . . . . . . . . . . 24 Section 35.972 Recentness of training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 J

e o STAFF LEVEL DRAFT DOCUMEN f August 7,1907 PREFACE The medical use of teletherapy units that contain a sealed source of cobalt 60 or cesium 137 is  !

a declining modality. The safety procedures captured in the current published NRC regulations involving the radiation beam output and use of the teletherapy unit are professional standard prcctice.

GENERAL Secti:n 35.000 TELE Use of a sealed source in a teletherapy unit.

The regulations and provisions of this subpart govern the use of teletherapy units that cont:in a sealed source of cobalt 00, cesium 137, or other approved radionuclide for medical uses as approved in the scaled souco and device registry.

S:ction 35.2 TELE Definitions.

Address of use means the building or buildings that are identified on the license and wh:ra radioactive material may be received, used, or stored.

Agroomont Stato means any State with which the Commission or the Atomic Energy Commission has entered into an effective agreement under subsection 274b of the Atomic En:rgy Act of 1954, as amended.

Area of uso means a portion of an address of use that has bee et aside for the purpose of r:cciving, using, or storing byproduct meterial.

Authorized user means a physician who is:

(1) Board certified by at least one of the boards listed in Paragraph (s) of 35.960; or (2) Identified as an authorized user of teletherapy units containing a cobait 60, cesium-137 or any other approved radionuclide on a Commission or Agreement State license that authorizes the medical use of teletherapy units containing a coba.c60, vesium-137 or any other approved radionuclide.

Dedicated chock source means a radioactive source that is used to aasure the constant op;rction of a radiation detection or measurement device over several months or yewe.

Depleted Uranium means the source material uranium in which the isotope uranium-235 is less than 0.711 weight percent of the total uranium present which is used for shielding arid collimators in a teletherapy unit. Depleted uranium does not include special nuclear material.

Management means the chief executive officer or that person's delegate or delegates.

Medical entity means any organization of medical practice that is not defined es a medical institution.

Medicallnstitution means an organization in which several rnedical disciplines are practiced and provides in patient care.

Medical use means the intentional external administration of the radiation from a t:letherapy unit to patients or human research subjects under the supervision of an authorized user.

e O STAFF LEVEL DRAFT DOCUMENT August 7,1997 Minor change means a change that is made, after ascertaining the applicable requirements, by persons in authority in conformance with the requirements and without making a discretionary judgment about whether those requirements should apply in the case at hand.

Output means the exposure rate, dose rate, or a quantity related in a known manner to these rates from a teletherapy unit for a specified set of exposure conditions.

Physiclan means a medical doctor or doctor of osteopathy licensed by a State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico to prescribe drugs in the practice of medicine.

Presenbed dose means for teletherapy, the total dose and dose per fraction as documented in the written directive.

Radiation Sa/uty O//icer means the individual identified as the Radiation Safety Officer "on a Commission license.

Reporfable medical event means an oral and/ or written report to the NRC involving:

(a) the administration of a teletherapy rad!ation dosa-involving the wrong individual, wrong mode of treatment, or wrong treatment site or when the calculated total administered dose differs from the total prescribed dose by more than 20 percent of the total prescribed dose; (b) a sealed source that is leaking; (c) any structural, mechanical, electrical or electronic malfunction of the toletherapy unit or its cncillary equipment, power supplies, and computerized treatment planning systems that may cff:ct the dose to a patient; or (d) any report required by sections 30.50 or 21.21 S9aled source means any radioactive material that is encased, embedded, or affixed in such a way as to prevent leakage, movement, or escape of the radioactive material from the source apparatus and is registered in accordance with section 32.210.

Teletherapy physicist means the individual identified as the teletherapy physicist on a Commission license.

Wn'tten directive means a written set of directions concerning patient or human research subject treatment from a teletherapy unit which includes, but is not limited to the following inf:rmation: the total dose, dose per fraction, treatment site, and overall treatment period for the specific patient or human research subject, dated and signed by an authorized user prior to the administration of radiation.

Section 35.6 Provisions for research involving human subjects.

A licensee may conduct research involving human subjects using byproduct material provided that the research is conducted, funded, supported, or regulated by another Federal Agency which has implemented the Federal Policy for the Protection of Human Subjects.

Otherwise, a licensee shall apply for and receive approval of a specific amendment to its NRC license before conducting such research. Both types of licensees shall, at a minimum, obtain informed consent from the human subjects and obtain prior review and approval of the research activities by an " Institutional Review Board"in accordance with the meaning of these terms as defined and described in the Federal Policy for the Protection of Human Subjects.

a o

. STAFF LEVEL DRAFT DOCUMENT August 7,1997 Section 35.7 FDA, other Federal, and State requirements.

Nothing in this part relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing research involving human subjects, radioactive drugs, or devices.

Section 35.999 TELE Resolution of conflicting requirements during transition period.

(a) If the requirements of this part or subpart are more restrictive than the existing license condition then the licensee shall comply with this part or subpart unless exempted by paragraph (c) of this section -

(b) Any existing license condition that is more restrictive than a requirement in this part or subpart remains in force until there is a license amendment or renewal.

(c) If a license condition exempted a licensee from a requirement in this part or subpart in cffective prior to (January,2000 ??), it continues to exempt a licensee from the corresponding provisions of this part or subpart.

(d) If a license conditions cites a provision of this part or subpart in effect prior to January,2000 and there is no corresponding provision after (January,2000 ??), then the license condition r; mains in effect until there is a license amendment or renewal that modifies or removes that condition, f

LICENSING PROVISlQMS Section 35.11 TELE License required.

(a) A person shall not manufacture, produce, acquire, receive, possess, use, or transfer byproduct material for medical use or depleted uranium collimators and shielding for a t:letherapy unit except in accordance with a specific license issued by the Commission or an Agreement State, or as allowed in paragraph (b) of this section.

(b) An individual may receive, possess, use, or transfer byproduct material or depleted uranium collimators and shielding for a teletherapy unit in accordance with the regulations in thb chapter under the supervision of an authorized user as provided in Section 35.25 unless prohibited by license condition.

(c) A licensee may use for medica 1 use only teletherapy units containing sealed sources manufactured and distributed in accordance with a license issued pursuant to 10 CFR Part 30 or the equivalent requirements of an Agruvment State.

- Section 35.12 TELE Applic$thn for license., amendment, or renewal.

. o STAFF LEVEL DRAFT DOCUMENT August 7,1997 (a) An application for medical use sited in a medicalinstitution may only be submitted by the int'.itution's management. An application for medical use not sited in a medicalinstitution, may be submitted by any person representing the highest level of management responsible for the medical entity.

(b) An application for a license for medical use of byproduct material as a sealed source in a t:letherapy must be made by filing an original and one copy of NRC Form 313, " Application for Mat: rials License " For guidance in completing the form, refer to the instructions in the most curr:nt version of the appropriate Regulatory Guide. A request for a license amendment or r:nowal may be submitted as an original and one copy in letter format.

(c ) For copies of regulatory guides, application forms, or to submit an application or an cmendment request, refer to Section 30.6 of this chapter.

Section 35.18 TELE License issuance.

The Commission shallissue a license for the medical use of byproduct materialif:

(a) The applicant has filed NRC Form 313 using the instructions in the most current version of th] appropriate Regulatory Guide in accordance with Section 35.12; (b) The applicant has paid any applicable fee as provided in part 170 of this chapter; (c) The Commission finds the applicant equipped and committed to observe the safety st:ndards established by the Commission in this Chapter for the protection of the public health 4 and safety; (d) The applicant meets the requirements of part 30 of this chapter, and Section 35.13 TELE License amendments.

A licensee shall apply for and must receive a license amendment:

(c) Before it receives or uses byproduct material for a medical use permitted under this part but not permitted by the license issued pursuant to this part; (b) Before it permits anyone to work as an authorized user or teletherapy physicist under th3 license, except an individual who is an authorized user certified by the organizations specified in paragraph (a) of Section 35.960 or identified as an authorized user on a Commission or Agreement State license that authorizes the use of byproduct materialin t:letherapy units containing cobalt-60, cesium-137, or other approved radionuclide; (c) Before it changes Radiation Safety Of'icers; (d) Before it orders byproduct materialin excess of the amount, or radionuclide or form different than authorized on the license; and (0) Before it adds to or changes the areas of use or address or addresses of use identified in the application or on the license.

(f) Before making any change in the treatment room shielding; (g) Before relocating the teletherapy unit; or making any change in the location of the t:letherapy unit within the treatment room;

STAFF LEVEL DRAFT DOCUMENT August 7,1997 (h) Before using the teletherapy unit in a manner that could result in increased radiation levels in areas outside the teletherapy treatment room; or Section 35. TELE 1 Authorization for depleted uranium Any person authorized by Section 35.11 for the medical use of a teletherapy unit containing a se: led cource of cobalt-60, cesium 135 or other approved radionuclide may receive, possess, and use up to 999 kilograms of depleted uranium for shielding and colimators in o teletherapy unit.

Section 35.57 TELE Authorization for calibration and reference sources.

Any person authorized by Section 35.11 for medical use of byproduct material as a sealed source in a teletherapy unit may receive, possess, and use the following byproduct material for check, calibration, and reference use: sealed sources manufactured and distributed by a person licensed pursuant to Section 32.74 of this chapter or equivalent Agreement State regulations and that do not exceed 15 millicuries each.

S:ction 35.14 TELE Personnel and address change notifications.

(a) A licenseo shall provide to the Commission a copy of the board certification, the Commission or Agreement State license, for each Individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user or teletherapy physicist pursu:nt to Section 35.13 (b) .

(b) A licenseo shall notify the Commission by letter no later than 30 days after:

(1) An authorized user, a Radiation Safety Officer, or teletherapy physicist permanently disc:ntinues performance of duties under the license or has a name change; or (2) The licensee's mailing address changes.

(c) The licensee shall mail the documents required in this section to the appropriate address id:ntified in Section 30.6 of this chapter.

Section 35.19 Specific exemptions.

The Commission may, upon application of any interested person or upon its own initiative, gr:nt such exemptions from the regulations in this part as it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest. The Commission will review requests for exemptions from training and cxperience requirements with the assistance of its Advisory Committee on the Medical Uses of isotopes.

EQUIPMENT TELETHERAPY UNIT PROGRAM

. o STAFF LEVEL DRAFT DOCUMENT August 7,1997 Section 35.620 TELE Possession, calibration and check of survey instrements.

(a) A licensee authorized to use byproduct material as a sealed source in a teletherapy unit sh:ll have in its possession either a fully operable and calibrated portable radiation detection surv:y instrument capable of detecting dose rate over the range 0.1 millirem per hour to 100 millir:m per hour or a portable radiation measurement survey instrument capable of measuring d:se rates over the range 1 millirem per hour to 1,000 millirem per hour.

(b ) A licensee shall calibrate the survey instruments used to show compilance with this part bef:re first use, annually, and following repair. The licensee shall:

(1) Calibrate all scales with readings up to 1000 millirem per hour with a radiation source; (2) Calibrate two separated readings on each scale that must be calibrated; and "~

(3) Conspicuously note on the instrument the apparent exposure rate from a dedicated check source as determined at the time of calibration, and the date of calibration.

(c) When calibrating a survey instrument, the licensee shall consider a point as calibrated if the indicated exposure rato differs from the calculated exposure rate by not mor] than 20 percent, and shall conspicuously attach a correction chart or graph to the instrument.

(d) A licensee shall check each survey instrument for proper operation with the dedicated check source each day of use. A licensee is not required to keep records of these checks.

Section 35.630 TELE Dosimetry equipment.

(a) A licensee shall have a calibrated dosimetry system available for use. To satisfy this requirement, one of the following two conditions must be met.

(1) The system must have been calibrated by the NationalInstitute of Standards and Technology or by a calibration laboratory accredited by the American Association of Physicists in Medicine (AAPM). The calibration must have been performed within the previous two years and aft:r any servicing that may have affected system calibration; or (2) The system must have been calibrated within the previous four years; eighteen to thirty months after that calibration, the system must have been intercompared at an intercomparison meeting with another dosimetry system that was calibrated within the past twenty four months by the National Instituto of Standards and Technology or by a calibration laboratory accredited by the AAPM. The intercomparison meeting must be sanctioned by a calibration laboratory or radiologic physics center accredited by the AAPM. The results of the intercomparison meeting must have indicated that the calibration factor of the licensee's system had not changed by more than 2 percent. The licensee may not use the intercomparison result to change the calibration factor. When intercomparing dosimetry systems to be used for calibrating cobalt-60 teletherapy units, the licensee shall use a teletherapy unit with a cobalt-60 source, When intercomparing dosimetry systems to be used for calibrating cesium 137 teletherapy units, the licensee shall use a teletherapy unit with a cesium 137 source.

(b) The licensee shall have available for use a dosimetry system for spot-check me:surements. To satisfy this requirement, the system may be compared with a system that has been calibrated in accordance with paragraph (a) of this section. This comparison must have

s s STAFF LEVEL DRAFT DOCUMENT August 7,1997 been performed within the previous year and after each servicing that may have affected system ,

calibration. The spot check system may be the same system used to meet the requirement in p ragraph (a) of this section.

Section 35. TELE 2 Therapy related computer systems

, The licensee shall assure that the computer treatment planning systems and computerized operating systems associated with the therapy device are operating appropriately.

RADIATION SAFETY WUIREMENTS Secti h 35.21 TELE Radiation Safety Officer.

(a) A licensee shall appoint a Radiation Safety Officer responsible for implementing the radiction safety program. The licensee, through the Radiation Safety Officer, shall ensure that radi: tion safety activities are being performed in accordance with approved procedures and regul: tory requirements in the daily operation of the licensee's byproduct material program.

(b) The Radiation Safety Officer shall, at a minimum:

(1) Review personnel exposure reports and investigate overexposures, accidents, leaking se: led sources, losses, thefts, unauthorized receipts, uses, transfers, disposals, reportable medical events, and other deviations from approved radiation safety practice and implement corr:ctive actions as necessary; (2) Establish, wiitten policies and procedures for implementing the radiation safety program.

(3) Brief management as needed, but not less than once each year, on the radiation safety program; (4) For medical use not at a medicalinstitution, approve or disapprove minor changes in radiction safety procedures pursuant to 35.31 that are not potentially important to safety with the advices and consent of management; and (5) Assist the Radiation Safety Committee in the performance of its duties, if such committee is required pursuant to Section 35.22, Section 35.22 TELE Radiation Safety Committee.

A Radiation Safety Committee must be established to oversee the medical use of NRC regulated material, the radiation therefrom, or the radiation from an NRC regulated utilization facility, if the licensee is authorized for more than one modality described in this part..

(a) The Committee must meet the following administrative requirements:

(1) Membership must consist of at least three individuals and must include an authorized user of each type of use permitted by the license, the Radiation Safety Officer, e-representative of the nursing service; and a representative of management who is neither an authorized user nor o Radiation Safety Otficer. Other members may be included as the licensee deems cppropriate.

(2) To establish a quorum and to conduct business, at least one-half of the Committee's

l STAFF LEVEL DRAFT DOCUMENT August 7,1997 membership must be present, including the Radiation Safety Officer and the management's representative.

(3) The Committee must meet at least quarterly .

(4) The licensee shal! prepare and certify the accuracy of the minutes of each Radiation '

S:fety Committee meeting.

(b) To oversee the use of licensed material, the Committee must:

(1)(l) Review, on the basis of safety and with regard to the training and experience standards in Sections 35.900 through 35.972 and approve or disapprove any individual who is to be listed as an authorized user, the Radiation Safety Officer, or a teletherapy physicist before submitting a license application or request for amendment or renewal; or (ii) Review, pursuant to Section 35.13 (b), on the basis of the board certification, the license, -

cr the permit identifying an individual, and approve or disapprove any individual prior to allowing th:t individual to work as an authorized user or teletherapy physicist; (2) Review on the basis of safety, and approve with the advice and consent of the Radiation Safety Officer and the management representative, or disapprove minor changes in radiation s:fety procedures provided the changes do not affect the standard of safety established in cpplicable NRC regulations; (3) Review at least annually, with the assistance of the Radiation Safety Officer, a summary of the occupational radiation dose records of all personnel working with byproduct material; (4) Review quarterly, with the assistance of the Radiation Safety Officer, allincidents involving byproduct material with respect to cause and subsequent actions tal(en; and (5) Review annually, with the assistance of the Radiation Safety Officer, the radiation safety program.

S:ction 35.23 TELE Statements of authority and responsibilities.

(c) A licensee shall provide the Radiation Safety Officer, and the Radiation Safety Committee, if such a committee is required, sufficient authority, organizational freedom, and m:nagement prerogative, to:

(1) Identify radiation safety problems; (2) Initiate, recommend, or provide corrective actions; and (3) Verify implementation of corrective actions.

(b) A licensee shall establish and state in writing the authorities, duties, responsibilities, and rad'Etion safety activities of the Radiation Safety Officer, and if required, the Radiation Safety Committee.

Section 35.25 Supervision.

(a) A licensee that permits the receipt, possession, use, or transfer of byproduct material by En individual under the supervision of an authorized user as allowed by Section 35.11(b) of this

l 4

STAFF LEVEL DRAFT DOCUMENT August 7,1997 part shall:

(1) Instruct the supervised individualin the principles of radiation safety appropriate to that individual's use of byproduct material and in the licensee's written quality management administration program; (2) Require the supervised individual to follow the instructions of the supervising authorized user, follow the written radiation safety and quality management program established by the licensee, and comply with the regulations of this chapter and the license conditions with respect 13 the use of byproduct material; and (3) Periodically review the supervised individual's use of byproduct material.

(b) A licensee that supervises an individualis responsible for the acts and omissions of the supervised individual.

Section 35.31TEl.E Radiation safety program changes.

A licensee may rnake minor changes in radiation safety procedures that are not potentially important to safety, except for those changes in Section 35.13 of this part. A licensee is r:sponsible for assuring that any change made is in compliance with the requirements of the regul:tions and the license.

Section,35.32 TELE Ouality management program (a) Each applicant or licensee under this part, as applicable, shall establish and maintain a writt:n program to provide high confidence that radiation from a teletherapy unit will be cdministered as directed by the authorized user. The program must meet the following specific cbjectives:

(1) That, prior to administration, a written directive 1_/ is prepared for any teletherapy r:d:: tion dose; 1_/ If, because of the patient's condition, a delay in order to provide a written revision to an cx:: ting written directive would jeopardize the patient's health, an oral revision to an existing writt:n directive will be accepiable, provided that the oral revision is documented immediately in the p;tient's record and a revised written directive is 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 dtegnestiew therapeutic procedure provided that the revision is dated and signed by an authorized user prior t) the administration of the teletherapy dose, or the next teletherapy fractional dose, if, because of the emergent nature of the patient's condition, a delay in order to provide a written directive would jeopardize the patient's health, an oral directive will be acceptable, 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.

l STAFF LEVEL DRAFT DOCUMENT August 7,1997 (2) That, prior to each administration, the patient's or human research subject's identity is verified by more than one method as the individual named in the written directive, .

(3) That final plans of treatment, related calculations, and each administration for the use of l the 1:letherapy unit are in accordance with the respective written directivest l and l (4) That any unintended deviation from the written directive is identified and evaluated, and cppropriate action is taken, (b) The licensee shall perform an audit of a representative sample of written directives at int:rv:Is no greater than 12 months to verify the effectiveness of the program, 3

Section 35,33 TELE Notifications, reports, and records of reportable medical events.

(eFFor-e medh! event *

(4)-The lhrn; ehe l acti'y by bbphera tra NRO Oper;the Oener 2_/ no bMr then the next cebader d;y eter dbeveri of the medkel event, 2_/-Tra eemmereb; bbphera number of the NRO Oper;the Cent; b (304) 010-5100:

(2pThe lhn;;; ahelt submit ; w;;tten reps;t to tra appropibb NRO Regba;; O"ce l bed in-40 OFR 304 withh 15 d;ya eter dbeari of themedhl cv;nt;-The ws;;Ma report mu;t include tra luns;'s nena; ; bibf deni;pth of tra :=nt; why tra event c;;uried; the eMeet on tra e#e;Md bdlvMual hvchd b the medhl : vent wh;; ;mprev.imente ;;; naded to prewn; recurrence; ;;th; ML:n is prev:nt recurrence, Tra reps;t mu;t act ceabb the eNeeted bdivMue!'s nem; ci eny ether bbim;;bn th;t ceuM l: d to Zent;0;;th of tra eMeeted bdivMael,

(:) AeMe bm the act:0eeth re u;rement, nethbg in thb x;;h ;#ecte any r;;he or duth of than;; and phyebbe b i;bth to ;=h other, to eMe;3d bdivMu;b ci to th;; ;%;;Md individuet's rspen;;bk i; bib; or guardh;:

NOTE: Criteria, threshold limit and extent of patient notification are unresolved Section 35.59 TELE Requirements for possession of sealed sources.

(c) A licensee in possession of any sealed source shall follow the radiation safety and h:ndling instructions supplied by the manufacturer, and shall maintain the instructions for the duration of source use in a legible form convenient to users.

(b) A licensee in possession of a sealed source shall:

(1) Test the source for leakage before its first use unless the licensee has a certificate from the supplier indicating that the source was tested within six months before transfer to the licensee; and (2) Test the source for leakage at intervals not to exceed six months or at other intervals approved by the Commission or an Agreement State and described in the label or brochure that

, a STAFF LEVEL DRAFT DOCUMENT August 7,1997 accompanies the source.

(c) To satisfy the leak test requirements of this section, the licensee must:

(1) Take a wipe sample from the scaled source or from the surfaces of the device in which the sealed source is mounted or stored on which radioactive contaminGilon might be expected to cccumulate or wash the source in a small volume of detergent solution and treat the entire volume as the sample; (2) Take teletherapy and other device source test samples when the source is in the "off" position; and (3) Measure the sample so that the leakage test can detect the presence of 0.005 microcuries of radioactive material on the sample.

(d ) If the leakage test reveals the presence of 0.005 microcurie or more of removable cont:mination, the licensee shall: -

(1) Immediately withdraw the sealed source from use and store it in accordance with the requircments in parts 20 and 30 of this chapter; and (2) File a report within five days of the leakage test with the appropriate NRC Office listed in S:ction 30.0 of this chapter, with a copy to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Cornmission, Washington, DC 20555, describing the equipment involved, the test results, and the action taken.

(c) A licensee need not perform a leakage test on the following sources:

(1) Sources containing only byproduct material with a half life of less than 30 days; (2) Sources containing only byproduct material as a gas; (3) Sources containing 100 microcuries or less of beta or gamma emitting material or 10 microcuries or less of alpha emitting material; (4) Sources stored and not being used. The licensee shall, however, test each such source f;r le:kage before any use or transfer unless it has been leakage-tested within six months beforo the date of use or transfer; and (5) Seeds of Iridium 192 encased in nylon ribbon.

(f) A licensee in possession of a sealed source shall conduct a physicalinventory of all such sources in its possession at a six month frequency.

(g) A licensee in possession of a sealed source shall perform such surveys to assure the limits cf part 20 are met in all areas where such sources are stored. This does not apply to t:letherapy sources in teletherapy units.

Section 35.605 TELE Five-year inspection, maintenance repair, and disposal restrictions.

(a) A licensee shall have each teletherapy unit fully inspected and serviced during t;letherapy source replacement or at intervals not to exceed five years, whichever comes first, to assure proper functioning of the source exposure mechanism.

(b) Installation, relocation, removal a teletherapy sealed source, removal a teletherapy unit that contains a sealed source, or removal of depleted uranium collimators and shielding from the teletherapy unit and maintenance, adjustments, or repair of the source drawer, the shutter or other mechanisms of a teletherapy unit that could expose the source, reduce the shielding around the source, or result in increased radiation levels and the five year inspection in

c

• STAFF LEVEL DRAFT DOCUMENT August 7,1997 p:ragraph (a) shall be performed only by a person specifically licensed to do so by the l Commission or an Agreement State. j (c) A licensee shall dispose of the removed teletherapy source, depleted uranium collimators l and shielding from the teletherapy unit in accordance with part 20 or section 30,41 of these regulations.

Section 35.610 TELE Safety instruction.

(a) A licensee shall post instructions at the teletherapy unit console. To satisfy this requirement, these instructions must inform the operator of:

4 (1)The procedure to be followed to secure the teletherapy unit, the concole, the console k:ys cnd the treatment room when not in use cr unattended; (2) The procedure to be followed to ensure that only the patient or the human research subject is in the treatment room before turning the primary beam of raalation on to begin a tr::tment or after a door interlock interruption; (3) The procedure to be followed to prevent the dual operation of more than one radiation producing device in a treatment room; and (4) The procedure to be followed if the operator is unable to turn the primary beam of radiction off with controlc outside the treatment room or any other abnormal operation occurs; and (5)'The names and telephone numbers of the authorized users and Radiation Safety Officer to be immed5tely contacted if the teletherapy unit or console operates abnormally.

(b) A licensee shall provide instruction in the topics identified in paragraph (a) of this section to cll cffected individuals who operate a teletherapy unit.

Section 35.615 TELE Teletherapy room access control and patient observation.

(c) A licensee shall control access to the teletherapy room by a door at each entrance.

(b) A licensee shall equip each entrance to the teletherapy room with an electrical interlock system that will:

(1) Prevent the operator frem tuming the primary beam of radiation on unless each tr;;tment room entrance door is closed; (2) Turn the primary beam of radiation off immediately when an entrance door is opened; cnd (3) Prevent the primary beam of radiation from being turned on fallowing an interlock intem>ption until all treatment room entrance doors are closed and the beam on-off control is r: set at the console.-

(c) A licensee shall equip each entrance to the teletherapy room with a beam condition indicator light.

(d ) A licensee shall construct or equip each teletherapy room to permit continuous -

observation of the patient or the human research subject from the teletherapy unit console during irradiation.

e +

STAFF LEVEL DRAFT DOCUMENT August 7,1997

35. TELE 3 Teletherapy room radiation monitor (a) A licensee shall installin each teletherapy room a permanent radiation monitor capable of continuously monitoring bearn status.

(1) A radiation monitor must provide visible notice of a teletherapy unit malfunction that results in an exposed or partially exposed source, and must be observable by an individual cntering the teletherapy room.

(2) A radiation rnonitor must be equipped with a backup power supply separate from the power supply to the teletherapy unit.

(3) A radiation monitor must be checked with a dedicated check source for proper operation cach day before the teletherapy unit is used for treatment of patients or human research subjects.

(4 ) If a radiation monitor is inoperablo, the licensee shall require any individual entering the 1:letherapy room to use a survey instrument or audible alarm personal dosimeter to monitor for cny malfunction of the source exposure mechanism that may result in an exposed or partially cxposed source. The instrument or dosimeter must be checked with a dedicated check scurce f:r proper operation at the be@,ning of each day of use.

(5) A licensee shall promptly repair or replace the radiation monitor if it is inoperable.

Section'35. TELE 4 Beam Quality A licensee that uses wedges, tissue compensating filters, blocks or other devices to affect the beam of radiation delivered to the patient shall assure that the transmission factor of such d: vices are determined and considered in the treatment plan for the dose delivery to the patient.

The tr:nsmis:; ion factors for all devices should be determined before initial use. For wedges, t:: sue compensating filters, blocks and other devices that can be subsequently used for other p:tients the transmission factors shall be verified during the the full calibration required in Section 35.632.

Section 35.632 TELE Full calibration measurements.

(c) A licensee authorized to use a teletherapy unit for medical use shall perform full calibr; tion measurements on each teletherapy unit:

(1) Before the first medical use of the unit; and (2) Before medical use under the following conditions:

(1) Whenever spot check measurements indicate that the output differs by more than 5 percent from the output obtained at the last full cal;bration corrected mathematically for radioactive decay; (ii) Following replacement of the source or following reinstallation of the teletherapy unit in a new location; (iii) Following any repair of the teletherapy unit that includes removal of the source or major repair of the components associated with the source exposure assembly; and (3) At intervals not exceeding one year.

o e  ;

i I

STAFF LEVEL DRAFT DOCUMENT August 7,1997 I e

(b) To satisfy the requirement of paragraph (a) of this section, full calibration measurements

must include determination of

(1) The output within +/ 3 percent for the range of field sizes and for the distance or range of dttances used for medical use; (2) The coincidence of the radiation field and the field indicated by the light beam localizing d;vice; (3) The uniformity of the radiation field and its dependence on the orientation of the useful beam; ,

(4) Timer constancy and linearity over the range of use; (5) On off error; and (6) The accuracy of all distance measuring and localization devices in medical use. .

! (7) The transmission factors for wedges, tissue compensating filters, blocks and devices as-

d; scribed in 35.646. t (c) A licensee shall use the dosimetry system described in Section 35.630 622 (a) to me:sure the output for one set of exposure conditions. The remaining radiation measurements .

required in paragraph (b)(1) of this section may be made using a dosimetry system that indicates r:lativa dose rates.

(d) A licensoe shall make full calibration measurements required by paragraph (a) of this section in accordance with either the procedures recommended by the Scientific Committee on

( - R:di: tion Dosimetry of the American Association of Physicists in Medicine that are described in Physics'in Medicine and Biology Vol.16, No. 3,1971, pp. 379 396, or by Task Group 21 of the .

Radttion Therapy Committee of the American Association of Physicists in Medicine that are described in Medical Physics Vol.10, No. 6,1983, pp. 741-771, and Vol.11, No. 2,1984, p.

213. (Both of these references have been approved for incorporation by reference by the Direct:r of the Federal Register. Copies of the documents are available for inspection at the NRC Library,11545 Rockville Pike, Rockville, Maryland 20852 2738. Copies of the documents tre clso on file at the Office of the Federal Register,800 North Capitol Street NW., suite 700, Washington, DC. A notice of any change in the material will be published in the Federal Reghter.)

(c) A licensee shall correct mathematically the outputs determined in paragraph (b)(1) of this section for physical decay for intervals not exceeding one month for cobalt-60 or six months for cesium-137.

(f) Full calibration measurements required by paragraph (a) of this section and physical decay corrections required by paragraph (e) of this section must be performed by the licensee's teletherapy physicist.

r Section 35.634 TELE Periodic spot-checks.

(a) A licensee authorized to use teletherapy units for medical use shall perform output spot-checks on each teletherapy unit once in each calendar month that include determination of:

(1) Timer constancy, and timer linearity over the range of use; (2) On-off error; (3) The coincidence of the radiation field and the field indicated by the light beam localizing

. , .-. _ _ __ __ . .- __ ._._ _ _ _ _ _ , _a

o a STAFF LEVEL DRAFT DCCUMENT August 7,1997 device; (4) The accuracy of all distance measuring and localization devices used for medical use; (5) The output for one typical set of operating conditions measured with the dosimetry system described in Section 35.630(b) of this part; and (6) The difference between the measurement made in paragraph (b)(5) of this section and the cnticipated output, expressed as a percentage of the anticipated output (i.e., the value obtained at last full calibration corrected mathematically for physical decay).

(b) A licensee shall perform measurements required by paragraph (a) of this section in cccordance with procedures established by the teletherapy physicist. That affected individual need not actually perform the spot-check measurements.

(c) A licensee shall have the teletherapy physicist review the results of each spot-check -

within 15 days. The teletherapy physicist *all promptly notify the licensee in writing of the r:sults of each spot check. The licensee shall keep a copy of each written notification for three y:ars.

(d) A licensee authorized to use a teletherapy unit for medical use shall perform safety spot checks of each teletherapy facility once in each calendar month that assure proper operation of:

(1) Electrical interlocks at each teletherapy room entrance; (2) Electrical or mechanical stops installed for the purpose of limiting use of the primary be:m of radiation (restriction of source housing angulation or elevation, carriage or stand trave?

cnd operation of the beam on off mechanism);

(3) Beam condition indicator lights on the teletherapy unit, on the control console, and in the f;cilliy; (4) Viewing systems; (5) Treatment room doors from inside and outside the treatment room; and (6) Electrically assisted treatment room doors with the teletherapy unit electrical power turned off.

(0) A licensee shall arrange for prompt repair of any system identified in paragraph (d) of this s:ction that is not operating properly, and shall not use the teletherapy unit following door int:rlock malfunction until the interlock system has been repaired.

Section 35.636 TELE Safety checks for teletherapy facilities.

(a) A licensee shall promptly check all systems listed in Section 35.634(d) for proper function cft:r cach installation of a teletherapy source and after making any change for which an amendment is required by Section 35.13 (f) through (h).

(b) If the results of the checks required in paragraph (a) of this section indicate the malfunction of any system specified in Section 35.634(d), the licenseo shalllock the control console in the off position and not use the unit except as may be necessary to repair, replace, or check the malfunctioning system.

Section 35.641 Radiation surveys for teletherapy facilities.

o .

STAFF LEVEL DRAFT DOCUMENT August 7,1997 A licensee shall make such surveys as defined in part 20 to assure that:

(C) The maximum and averago dnse rates at one meter from the teletherapy source with the source in the off position and the collimators set for a normal treatment field do not exceed 10 millirem per hour and 2 millirem per hour, respectively; and that (b) (1) Radiation levels in restricted areas are not likely to cause personnel exposures in excess of the limits specified in Section 20.1201 of this chapter; and (2) radiation levels unrestricted areas do not exceed the limits specified in Section 20.1301 of this chapter when the telethorapy source is in the on position with the largest clinically cvail:ble treatment field and with a scattering phantom in the primary beam of radiation (c) A record of surveys performed before medical use at the time of initialinstallation of the t:lethorapy source and unit at the licensee's facility may be used as a generic survey provided -

the source activity at subsequent source relacements remain equal to or less than the initial source activity or the teletherapy unit and there are no other changes in the licensee *s t:l: therapy facility.

(d) If the licensee's surveys do not assure that the limits stated in paragraph (a) are met, the licensee shalllock the controlin the off ponition and not use the unit:

(1) Except as may be necessary to repair, replace, or test the teletherapy unit shielding or tha trcatment room shielding; or (2) Until the licensee has recolved a specific exemption pursuant to Section 20,1301 ot' this ch:pt^:r.

S:ction 35.643 Modification of teletherapy unit or room before beginning a treatment program.

(0) If the licensee's surveys as defined in part 20 do not assure that the limits stated in s:ction 35.641(b)(2) are met, the licensee shall:

(1) Either equip the unit with stops or add additional radiation shielding to ensure compliance with Section 1301(c) of this chapter; (2) Perform the survey required by Section 35.641 again; and (3) include in the report required by Section 35.645 the results of the initial survey, a description of the modification made to comply with paragraph (a)(1) of this section, and the r:sults of the second survey, (b) As an alternative to the requirements set out in paragraph (a) of this section, a licensee m;y request a license amendment under Section 20.1301(c) of this chapter that authorizes radiction levels in unrestricted areas greater than those permitted by Section 20.1301(a) of this ch:pt:r. A licensee may not begin the treatment program until the license amendment has been issued RECDHQS 35.5 Maintenance of records 35.645 Reports of teletherapy surveys, checks, tests, and measurements.

Section 35.5 Maintenance of records.

STAFF LEVEL DRAFT DOCUMENT August 7,1997 Each record required by this part must be legible throughout the retention period specified by cach Commission regulation. The record may be the original or a reproduced copy or a microform provided that the copy or microform is authenticated by authorized personnel and that the microform is capable of producing a clear copy throughout the required retention period. The r: cord may also be stored in electronic media with the capability for producing legible, accurate, and complete records during the required retention period. Records such as letters, drawings, specifications, must include all portinent information such as stamps, initials, and signatures.

The licensee shall maintain adequate safeguards against tampering with and loss of records.

Records shall be kept for, but not kmited to, the results obtained for the following regulations in this subpart:

Fiv>yearinspection por 35.605 A licensee shall keep a record of the inspection and servicing for th] duration of the license. The record must contain the inspector's name, the inspector's licenso number, the date of ineoection, the manufacturer's name and model number and serial number for both the teletherapy unit and source, a list of components inspected, a list of components serviced and the type of service, a list of components replaced, and the signature of th] inspector S:f:ty checks for tolotherapy facilitios por 35.636 A licensee shall retain for five years a record of tha facility checks made pursuant to Section 35.634(d) of teletherapy room access control and patient observation systems required by Section 35.615 following installation of a source. The record must include notations indicating the operability of each entrance door interlock, each CI:ctrical or mechanical stop, each beam condition indicator light, the viewing sys'em, and doors, and the signature of the Radiation Safety Officer.

Tclotherapy room radiation monitorpor 35. TELE 3 A licensee shall maintain a record of the room monitor check and use of a survey meter required by Sections 35. TELE 3(a)(3) and (a)(4) for fiva years. The record must include the date of the check, notation that the monitor indicates wh;n its detector is and is not exposed, and the initials of the individual who performed the check.

R: diction surveys for talothorapy facilities por 35.641 A licensee shall retain a record of the radi: tion measurements as described in Section 35.641 for the duration of the license. The r: cord must include the date of the measurements, the reason the survey is required, the m:nufacturer's name, model number and serial number of the teletherapy unit, the source, and the instrument used to measure radiation levels, each dose rate measured around the INherapy source while in the off position and the average of all measurements, a plan of the cr;:s surrounding the treatment room that were surveyed, the measured dose rate at several points in each area expressed in millirem per hour, the calculated maximum quantity of radiation over a period of one week for each restricted and unrestricted area, and the signature of the Radi: tion Safety Officer.

C:libration and chsck of survey instruments por 35.620 A licenseo shall retain a record of each

.= _- .

o o STAFF LEVEL DRAFT DOCUMENT August 7,1997 survey instrument calibration for five years. The record must include:

. (1) A description of the calibration procedure; and (2) The date of the calibration, a description of the source used and the certified exposure rates from the source, and the rates indicated by the instrument being calibrated, the correction f ctors deduced from the calibration data, and the signature of the individual who performed the calibration.

Dosimetry equipmentpor 35.630 The licensee shall retain a record of each calibration, int:rcomparison, and comparison for the duration of the license. For each calibration, intercomparison, or comparison, the record must include the date, the model numbers and serial numbers of the instruments that were calibrated, intercompared, or compared as required by

~

p:ragraphs (a) and (b) of this section, the correction factor that was determined from the calibration or comparison or the apparent correction factor that was determined from an int:rcomparison, the names of the individuals who performed the calibration, intercomparison, or comparison, and evidence that the intercomparison meeting was sanctioned by a calibration labor; tory or radiologic physics center accredited by AAPM.

R: diction Safety Officerpor 35.21 A licensee's Radiation Safety Officer shall keep a copy of all r: cords and reports required by the Commission regulations, a copy of these regulations, a copy of c:ch licensing request and license and amendments, and the written policy and procedures r: quired by the regulations.

R: diction Safety Committoo per 35.22 A licensee shall maintain recoreds of each Radiation S fety Committee meeting required by Section 35.22 and retain each record for the duration of the license. For each Radiation Safety Committee meeting, the records must include:

(I) The date of the meeting; (ii) Members present; (iii) Members absent; (iv) Summary of deliberations and discussions; and (v) Recommended actions and the numerical results of all ballots St:tements of authority and responsibilities per 35.23 A licensee shall retain the current edition cf statements as a record until the Commission terminates the license Supervision per35.25 A licensee shall keep records of the periodical review of supervised individual's use of byproduct material for five years.

Radiation safety program changes per 35.31 A licensee shall retain a record of each minor ch:nge made in accordance with Section 35.31 until the license has been renewed or terminated. The record must include the effective date of the change, a copy of the old and new radiation safety procedures, the reason for the change, a summary of radiation safety matters th:t were considered before making the change, the signature of the Radiation Safety Officer cnd management or, if required, the Radiation Safety Committee's chairman and the

O 4 STAFF LEVEL DRAFT DOCUMF.NT August 7,1997 management representative.

Quality Management program per 35.32, A licensee shall keep records of each audit performed to determine the effectiveness of the medical administration program per Section 35.642(b) for fiv3 years. The licensee shall retain (1) each written directive; and (2) a record of each cdministered radiation dose where a written directive is required in an auditable form, fer five ye:rs after the date of administration.

Notifications, reports, and records of medical events per 35.33 Each ;;cen;cc sha;l retain-e recordef-each-fspcriable medica l event invciving an administration of a radiatica dc;c ficm a te!stherapydsnit for 5 years-The reccid must contain the name of the a'fected individual invc!vca, the eff 3cted individuare accial accafity-number or otheNdentificatiomnumber ifene-has-been assignedra-brief dc:cription of the medical evcat, vehy it cccurred, the effect on the effected-individual, impicvaments accded to prevcat recurrence, and the actions taken to prevent-fecuffencedecords-of cther reportable medical events as defined in Sectica 35.0M shalbeentein-information-as-fequired by Sections-30-60(c)(E) or 21.21(c)(4) as applicable.

Requirements forpossession of sealed sources per 35.59 A licensee shall retain leakage test cords for five years. The records must contain the model number, and serial number if assigned, of c:ch. source tested, the identity of each source radionuclide and its estimated activity, the m::sured activity of each test sample expressed in microcuries, a description of the method used to measure each test sample, and date of the test. A licensee shall retain each inventory r: cord for five years. The inventory records must contain the model number of each source, and scri:1 number if one has been assigned, the identity of each source radionuclide and its nominal activity, and the location of each source. A licensee shall retain a record of each survey required in Section 35.59(g) of this section for five years. The record must include the date of the surv:y, a plan of each area that was surveyed, the measured dose rate at several points in each 800 cxpressed in millirem per hour, and the survey instrument used.

S:lety instn>ction per 35.610 A licensee shall retain for five years a record of the individuals r:ceiving instruction required by Section 35.010(b), a description of the instruction, the date of instruction, and the name of the individual who gave the instruction.

Full calibration measurements per 35.632. A licensee shall retain a record of each calibration for the duration of use of the teletherapy unit source, The record must include the date of the calibration, the manufacturer's name, model number, and serial number for both the teletherapy unit cnd the source, the model numbers and serial numbers of the instruments used to calibrate

, the teletherapy unit, tables that describe the output of the unit over the range of field sizes and for the range of distances used in radiation therapy, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, an assessment of timer

'line:rity and constancy, the calculated on-off error, the estimated accuracy of each distance me;suring er localization ot.vice, and the signature of the teletherapy physicist.

o

• STAFF LEVEL DRAFT DOCUMENT August 7,1997 Periodic spot-checks por 35.634 The licensee shall keep a copy of each written notification required by Section 35.634(c) fu five years. A licensee shall retain a record of each spot-check required by Section 35.634(a) and (d) for five years. The record must include the date of the spot-check, the manufacturer's name, model number, and serial number for both the teletherapy unit cnd source, the manufacturer's name, model number and serial number of the instrument used to measure the output of the teletherapy unit, an assessment of timer linearity and constancy, the calculated on off error, a determination of the coincidence of the radiation field and the field indicated by the light beam localizing device, the calculated on-off error, the d;t:rmined accuracy of each distance measuring or localization device, the difference between the cnticipated output and the measured output, notations indicating the operability of each cntrcnce door electrical interlock, each electrical or rnechanical stop, each beam (9ndition indicator light, the viewing system and doors;~and the signature of the individual who performed thJ periodic spot check Safety checks for teletherapy facilities S:ction 35.645 Reports of tetherapy surveys, checks, tests, and measurements A licensee shall mail a copy of the records required in Sections 35.636,35.641,35.643, and tho output from the teletherapy source expressed as roentgens or rads per hour at one meter from th.e source and determined during the full calibration required in Section 35.632, to the cppropriate Commission Regional Office listed in Section 30.6 of this chapter within thirty days following completion of the action that initiated the record requirement.

. TRAINING S:ction 35.900 Radiation Safety Officer, Except as provided in Section 35.901, the licensee shall require an individual fulfilling the rcsponsibilities of the Radiation Safety Officer as provided in Section 35.32 to be an individual who:

(c) is certified by:

(1) American Board of Health Physics in Comprenensive Health Physics; (2) American Board of Radiology; (3) American Board of Nuclear Medicine; (4) American Board of Science in Nuclear Medicine; (5) Board of Pharmaceutical Specialties in Nuclear Pharmacy; (6) American Board of Medical Physics in radiation oncology physics; (7) Royal College of Physicians and Surgeons of Canada in nuclear medicine; (8) American Osteopathic Board of Radiology; or (9) American Osteopathic Board of Nuclear Medicine; or (b) Has had classroom and laboratory training and experience as follows:

(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includes:

(I) Radiation physics and instrumentation;

O

• STAFF LEVEL DRAFT DOCUMENT August 7,1997 (ii) Radiation protection; (iii) Mathematics pertaining to the use and measumment of radioactivity; (iv) Radiation biology; and (v) Radiopharmaceutical chemistry; and (2) One yea. of full time experience as a radiation safety technologist at a medical institution under the supervision of the affected individualidentified as the Radiation Safety Officer on a Commission or Agreement State license that authorizes the medical use of byproduct material; Cr (c) Be an authorized user identified on the licensee's license.

Section 35.001 Training for experienced Radiation Safety Off;cer.

An Individualidentified as a Radiation Safety Officer on a Commission or Agreement State license before October 1,1986 need not comply with the training requirements of Section 35.000.

Section 35.960 Training for teletherapy.

Except as provided in Section 35.979, the licensee shall require the authorized user of a sried, source listed in Section 35.600 in a teletherapy unit to be a physician who:

(a) Is certified !n:

(1) Radiology, therapeutic radiology, or radiation oncology by the American Board of Radiology; (2) Radiation oncology by the American Osteopathic Board of Radiology; (3) Radiology, with specialization in radiotherapy, as a British " Fellow of the Faculty of R:diology" or " Fellow of the Royal College of Radiology"; or (4) Therapeutic radiology by the Canadian Royal College of Physicians and Surgeons; or (b) Is in the active practice of therapeutic radiology, and has had classroom and laboratory training in basic radioisotope techniques applir 'le to the use of a sealed source in a t~.letherapy unit, supervised work experience, anJ supervised clinical experience as follows:

(1) 200 hours0.00231 days <br />0.0556 hours <br />3.306878e-4 weeks <br />7.61e-5 months <br /> of classroom and laboratory training that includts:

(I) Radiation physics and instrumentation; (ii) Radiation protection; (iii) Mathematics pertaining to the use and measurement of radioactivity; and (iv) Radiation biology; (2) 500 hours0.00579 days <br />0.139 hours <br />8.267196e-4 weeks <br />1.9025e-4 months <br /> of supervised work experience under the supervision of an authorized user at a medical institution that includes:

(1) Review of the full calibration measurements and periodic spot checks; (ii) Preparing treatment plans and calculating treatment t mes;

. (iii) Using administrative controls to prevent misadministration; (iv) Implementing emergency procedures to I.:, followed in the event of the abnormal operation of a teletherapy unit or console; and (v) Checking and using survey meters; and

o .

STAFF LEVEL DRAFT DOCUMENT August 7,1997 (3) Three years of supervised clinical experience that includes one year in a formal training program approved by the Residency Review Committee for Radiology of the Accreditation Council for Graduate Medical Education or the Committee on Postdoctoral Training of the Americare Osteopathic Association and an additional two years of clinical experience in ther:peutic radiology under the supervision of an authorized user at a medicalinstitution that includes:

(1) Examining individuals and reviewing their case histories to detcrmine their suitability for 1:letherapy treatment, and any limitations or contraindications; (ii) Selecting the proper dose and how it is to be administered; (iii) Calculating the teletherapy dosen and collaborating with the authorized user in the r; view of patients' or human research subjects' progress and consideration of the need to modify originally prescribed doses as warranted by patients' or human research subjects' r :ction to radiation; and (iv) Post administration follow up and review of case histories.

Section 35.961 Training for toletherapy physicist.

The licensee shall require the teletherapy physicist to be an individual who:

(0) la certified by the American Board of Radiology in:

(1) Therapeutic radiological physics; (2)' Roentgen ray and gamma ray physics; (3) X ray and radium physics; or (4) Radiological physics; or (b) is certified by the American Board of Medical Physics in radiation oncology physics; or O Holds a master's or doctor's degree in physics, biophysics, radiolcgical physics, or health physics, and has completed one year of full time training in therapeutic radiological physics and cn additional year of full time work experience under the supervision of a teletherapy physicist at a medicalinstitution that includes the tasks listed in Sections 35.59 644, E632,35.034, sad B5444 35.647,35.648, and 35.625 of this part.

Section 35.970 Training for experienced authorized users.

Physicians identified as authorized users for the medical a teletherapy unit on a Commission cr Agreement State license issued before April 1,1987 who perform only those methods of use for which they were authorized on that date need not comply with the training requirements of 35.960.

Section 35.972 Recentness of training.

! The training and experience specified in this subpart must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

I

O 8 STAFF LEVEL DRAFT DOCUMENT August 7,1997

'" END OF DOCUMENT *"

4