ML20217C944

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Requests Addl Info in Order to Continue Review of License Application
ML20217C944
Person / Time
Issue date: 03/17/1998
From: Henson J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II)
To: Sarah Turner
AFFILIATION NOT ASSIGNED
References
257772, NUDOCS 9803270243
Download: ML20217C944 (2)
v • d • e


Text

March 17e 1998 Commonwealth Cancer Institute ATTN: Steve Turner Office Manager 1109 West Marshall Street Richmond, Virginia 23220

SUBJECT:

REQUEST FOR ADDITIONAL INFORMATION CONCERNING LICENSE APPLICATION DATED DECEMBER 18, 1997 (REFERENCE CONTROL NO. 257772)

Dear Mr. Turner:

This letter is in reference to your radioactive material application dated December 18, 1997. After careful review of your application it was determined that information submitted was incomplete and additional information is needed in order to process your application for a new license.

Enclosed you will find NRC's Policy and Guidance Directive FC 86-4:

Revision 1. "Information Required for Licensing Remote Afterloading Devices",

and the Addendum to this revision. Please review the licensing guide and accordingly resubmit your license application based on the requirements outlined in the guide. Please include in your revised application specific information regarding the HDR/ Simulator Room (i.e. the type and density of materials used in barriers and shields and drawings to scale) so that we may verify shielding calculations submitted.

Our review of your license application request will continue upon receipt of the above referenced information, Please forward two copies of your reply and refer to Control Number 257772. If you wish, replies may be transmitted via electronic facsimile to (404) 562-4955. You should then mail'the original I copy of any electronically transmitted documents.

If we don't receive a response within 30 days. we will assume you do not want I to pursue a license and will void your request.

If you have any question, please call Andrea R. Jones at (404) 562-4726.

Sincerely, original signed by C. Hosey for Jay L. Henson. License Reviewer i Division of Nuclear Materials Safety

Enclosure:

1. NRC Policy and Guidance Directive l FC 86-4, Revision 1 '
2. Addendum to Revision 1 - NRC Policy and Guidance Directive FC 86-4. Revision 1 cc: w/ encl: ,

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POLICY AND GUIDANCE DIRECTIVE FC 86-4; Revision 1 INFORMATION REQUIRED FOR LICENSING REMOTE AFTERLOADING DEVICES FC 66-4, Rev. I. Enclosure 1

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INFORMATION REQUIRED FOR LICENSING LOW, MEDIUM, AND HIGH DOSE RATE REMOTE AFTERLOADING BRACHYTHERAPY DEVICES This document contains references to sections of the revised 10 CFR Part 20, which becomes mandatory for all NRC licensees on January 1,1994. If the licensee has not chosen to adopt the revised Part 20, the reviewer should first remind the licensee that the they will have to comply after January 1, 1994, and, if the licensee elects to procede under the "old" Part 20, reference the appropriate corresponding rections from the "old" Part 20.

NOTE: the licensee has a NRC medical use license and wishes to amend the j existing license to permit use of a remote afterloading brachytherapy device, I it is not necessary for the licensee to submit detailed information for calibration of survey instruments, radiation safety committee membership or responsibilities, personnel monitoring program, leak testing or ALARA programs, unless any of these aspects of the licensee's program change because of this amendment request. Changes in aforementioned programs which are more than ministerial may be addressed in the amendment request. Other changes which may require notification to NRC include changes in the licensee's Quality Management (QM) program if the existing QM program does not address brachytherapy procedures to be performed using a remote afterloading device.

Such a change should be submitted by the licensee as a modification to their existing QM program. Both new applications and amendments to include brachytherapy to an existing program require a commitment by the licensee to provide the training in their QM program required by 10 CFR 35.25.

The attachments to this document include (1) a checklist to be used when reviewing amendment requests for remote afterloading brachytherapy devices, (2) a listing of standard license conditions which are specific to these devices, and (3) an index for quickly identifying the items that pertain to a specific type (e.g. high , medium , low , or pulsed-dose rate) of remote afterloader.

For licensing purposes, this guidance defines the following terms as:

a "high dose rate" (HDR) to mean a dose rate of 20 or more centigray

(" ads) per minute; e dium dose rate" (MDR) to mean a dose rate between 200 centigray s ads) per hour and 20 centigray (rads) per minute; and

=

" low dose rate" (LDR) to mean a dose rate of 4-200 centigray (rads) per hour.

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" pulsed dose rate afterloader" (PDR) refers to a special type of remote afterloading device that uses a single source capable of delivering dose rates in the "high dose rate" range, but is used to simulate the radiobiology of a low dose rate treatment by inserting the source for a given fraction of each hour. Based solely on their instantaneous exposure rate, these devices are treated the same as high dose rate devices in this document.

FC 86-4, Rev.1 1

_____________________________________-____i

I. Description of the Source (s) and Device (s)

A. Source description If the licensee wishes to possess and use more than one radionuclide in the device, the information specified in items 1-4 below should be provided for each radionuclide.

1. Radionuclide
2. Manufacturer's name and model number Information on whether the device and/or source (s) proposed for use within the device have had a radiation safety evaluation by either the NRC or an Agreement State can be obtained from the NRC's " Registry of Sealed Sources and Devices". If such a review has not been conducted for the specific source / device model(s), the licensee must request a copy of " Guide for the Preparation of Apolications for Radiatinn Safety Evaluation and Registr4 tion of Devices Containing Byproduct Material" or " Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material", as appropriate, from the regional NRC office and submit the information requested therein to NRC for review.

NOTE: Licenses should not be conditioned to permit uses of remote afterloaders that are contrary to conditions of use and/or limitations as set forth in the registration certificate (s) for the device and/or source (s).

3. Maximum activity, in curies, per device, which may not exceed the activity specified by the manufacturer for the specific device and source combination in the aforementioned

" Registry of Radioactive Sealed Sources and Devices".

4. Maximum number of sources to be possessed at the facility.

A licensee may wish to request two sources (or sets of sources), one (set) to be used in the device and one (set) to be stored in its shipping container, to accommodate the total quantity of material in the licensee's possession during replacement of the source (set) in the remote afterloading device. If more than one source model is referenced in Item 2 above, the licensee must indicate the maximum number of sources requested of each model number.

The product of the maximum activity per source times the number of sources permitted for each specific source model will be entered as the total possession limit for each source model.

[5. The licensee must request authorization for possession of FC 8f,-4, Rev.1 2.

depleted uranium in quantities sufficient to include shielding material in both the device (s) and source containers used for source exchange. Review the manufacturer's specifications for each device specified in the licensee's amendment request to determine (1) whether depleted uranium is used for shielding the source (s) within the device and (2) the total quantity of depleted uranium present in the device (in kilograms). Consult the manufacturer's specifications or the source supplier to determine whether depleted uranium is contained within shielding source containers used during source exchange and determine the total quantity of depleted uranium in such containers (in kilograms). This will be included in license condition numbers 6 through 9.

NOTE: Licensees may maintain one or more source containers at their facility as a backup shielded container for use in the event that a source cannot be retracted into the afterloading device and has to be recovered manually.

B. Device description ,

1. Manufacturer's name, address, and telephone number (also refer to Item I.A.2 above regarding registration information) for each device requested.
2. Model name and/or number and serial number for each device requested.

KII. Intended Use The licensee must specify the uses, or types of treatment, planned for the device. A typical response is "to be used for interstitial and/or intracavitary treatment of cancer in humans." Any other intended uses, such as intraluminal, intraoperative or non-human e.g., physics calibrations or medical research etc., use should be described in sufficient descriptive detail, that the intended uses are apparent to the license reviewer. ,

III. Proposed Users A. Physician authorized users of limited scope

1. If the license is of limited scope, the licensee must submit information verifying that the proposed authorized physician user meets the requirements set forth in 10 CFR 35.940(a) or (b).
2. In lieu of the above, the licensee may submit the name and license number of the NRC or Agreement State license on which the physician is authorized to use sources for FC 86-4, Rev.1 3

A brachytherapy (10 CFR 35.400).

3. If the licensee already has physician-users approved for use of 10 CFR 35.400 material, the licensee may simply state that use of the device will be limited to use by those individuals.
4. If the license is of broad scope, the licensee should state that the Radiation Safety Committee will approve users for the device (s) who are physicians, in accordance with 10 CFR 35.2, and who meet requirements specified in 10 CFR 35.940.

B. Authorized physicist (s)

If the license is of limited scope, the licensee must submit

[1. information verifying that the proposed authorized physicist user meets the requirements set forth in 10 CFR 35.961.

2. In lieu of the above, the licensee may submit the name and license number of the NRC or Agreement State license on which the physicist is authorized as either a teletherapy or brachytherapy physicist.
3. If licensee is of broad scope, the licensee should state that the Radiation Safety Committee will approve users for the device (s) who are physicists, in accordance with 10 CFR 35.2, and who meet requirements specified in 10 CFR 35.961.
4. Refer the qualifications of a proposed authorized physicist, who does not meet the qualifications set forth in 10 CFR 35.961, to NMSS for consideration as a technical assistance request unless the reviewer can make a determination that the individual is Egl qualified.

IV. Training for Individuals A. An outline of initial training that the licensee gives to authorized physician users and device operators, including a description of the, didactic portion of the training and the minimum (should be no less that 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />) hours of " hands on" device operation training that will be provided, must be submitted. Training should be specific to the device model, and include the following:

1. Radiation protection and instrumentation, including the proper use of personnel dosimeters, survey instruments, and radiation monitors.
2. The licensee's operating and emergency procedures.

FC 86-4, Rev.1 4

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3. Design, use and function of the davice, including safety systems.
4. On-the-job training in actual operation of the device under I the direct supervision of an experienced device user. This aspect of the training should include " dry runs" (using {

dummy sources) of routine patient set-up and treatment, as  !

well as implementation of the licensee's emergency {

procedures.

[ 5. Method of determining each trainee's competency to use the device for each type of proposed use.

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B. The name, affiliation, and qualifications of the instructor (s) J conducting the training discussed above must be submitted. A

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description of the trainer's experience in use of the specific '

device (s) for which training will be provided to licensee l personnel must be included.

C. An outline of the topics to be covered during periodic retrainina of device operators must be submitted and the licensee must confirm that retraining will be conducted at intervals not to exceed 12 months. The licensee must also confirm that retraining will include practice in implementing (using dummy sources) the licensee's emergency procedures (dry run).

D. The licensee must submit a description of the orientation trainino that will be provided to ancillary staff (including nurses, technologists, security staff, custodians, etc.) who provide patient care during treatment or frequent areas where remote '

afterloading devices are stored or used. This training must meet the requirements of 10 CFR 19.12 and 10 CFR 35.410. The licensee must confirm that the aforementioned staff will be provided refresher training, as appropriate, at intervals not to exceed 12 months. An outline of the training to be provided for ancillary personnel must be submitted for review.

Training provided for ancillary nursing personnel caring for patients undergoing treatment with a low dose rate remote afterloaditg device in a patient room should be consistent with l 10 CFR 35.410(a)(1), (2), (3) and (5). In addition, the licensee should confirm that nursing personnel will be provided training in the proper use of a survey instrument if patient care requires that nursing personnel work in close proximity to the patient.  !

Alternatively, the licensee must confirm that an individual trained in the use of a survey instrument and the procedures specified in 10 CFR 35.410 will be present during periods when patient care is performed.

Note: Training provided to nursing personnel caring for patients undergoing treatment with a low dose rate remote afterloading FC 86-4, Rev.1 5

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I device should be consistent with, and should include, the applicable procedures submitted under Section VIII.

E. The licensee must confirm that records of initial and refresher training provided for both device operators and ancillary K personnel will be maintained for a period of three years. Such records must include the names of the instructors, the names of attenders, and an outline of the topics discussed. l V. Facilities A. The licensee must submit annotated drawings (not blueprints) of each dedicated treatment room indicating:

k. Scale, plan and elevation.

i

12. Identification of the room (s), inciuding room number (s).

Type, density and thickness of all shielding materials, d3. including walls, floor and ceiling. i

4. Location of doors, windows, conduits, etc.

4 Distance to and the nature of use for adjacent areas with indication of whether the areas are restricted or unrestricted, as defined in 10 CFR 20.1003.

NOTE: Treatments using pulsed, medium, and high dose rate afterloading devices must be performed in rooms specially constructed or modified for radiation therapy. The use of pulsed, medium, and high dose rate afterloading devices must be restricted to the specific room described in the licensee's application.

Relocation of a pulsed, medium or high dose rate afterloading device to another area of use requires prior NRC approval through a license amendment.

B. If the licensee requests authorization to use a low dose rate afterloading device in multiple rooms rather than in a dedicated room, the following information must be submitted:

1. The licensee must confirm that when portable shields are required to obtain compliance with 10 CFR 20.1301, a positive method (such as permanent position markings or electrical / mechanical shield interlocks) of ensuring that the shield (s) are correctly positioned for each treatment will be employed.
2. The licensee must confirm that promptly after initiating treatment, surveys of restricted and unrestricted areas contiguous with the treatment room will be conducted to demonstrate compliance with 10 CFR Part 20.

FC 86-4, Rev.I 6

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3. The licensee must confirm that records of the surveys described above will. be maintained for a period of three years and that such records will include an annotated drawing of the room used for treatment (showing the configuration of the portable shields relative to the patient,1f applicable), the measured dose rate at several points in contiguous restricted and unrestricted areas, the instrument used to make the survey, and the initials of the individual who made the survey.
4. The licensee must confirm that after relocating a device to a new location (room), and prior to treatment, that all safety features and interlocks are operating properly.

NOTE: Low dose rate devices may be licensed for use in multiple rooms within a single building provided that portable shields are used to obtain compliance with the dose limi.ts of 10 CFR 20.1301 for unrestricted areas adjacent to the treatment room (patient room) if applicable.

C. The licensee must equip each dedicated treatment room for high and medium dose rate devices with continuous viewing and intercom systems to allow for patient observation during treatment. A description of the systems must be provided with the application and must include:

1. The primary intercom and viewing system.
2. Backup systems to be used if the primary systems fail or, alternatively, the licensee should commit to suspend further ,

treatments until the primary system is repaired.

For patient rooms where treatment using a low dose rate afterloading device is planned, the licensee must describe how the patient and device will be monitored during treatment to ensure 3 that.the sources and catheter guide tube are not disturbed during  !

treatment and to provide for prompt detection of any operational l problems with the afterloading device during treatment.

D. The licensee must provide a description of the security to be provided for each room where a remote afterloading device is to be used or stored. Areas or rooms'used to store remote afterloading 4 devices or source containers housing a source (sources) must be secured in accordance with 10 CFR 20.1801.

1. For medium and high dose rate devices which will be used in a dedicated treatment room, a description of the following is required:

(a) The physical / administrative control of access.

FC 86-4, Rev.1 7

(b) The electrical interlock system installed at each entry, including the result of interrupting the interlock when the source is exposed (i.e., whether the source is automatically retracted).

(c) The actions required following interruption of the interlock prior to resuming treatment, including confirmation that the interlock must be reset before the afterloading device can be activated. )

g(d) The actions required in the event of malfunction of the interlock system. The licensee must confirm that if the system malfunctions, the afterloading device will be locked in the "off" position and not used, except as may be necessary for repair or replacement of the interlock system, until the interlock system is shown to be functioning properly.

(e) Restricted area controls (e.g., signs, locks, j visible / audible alarms, etc.), including descriptions  !

of signs with their location, sizes and wording (also {

see V.H.). (

l (f) The licensee must confirm that no other radiation-producing devices are located in the treatment room, or provide a description of the mechanisms installed to ensure that only one device can be placed in operation at a time.

(g) Method to ensure that whenever the afterloader device is not in use or is unattended, the console keys will be inaccessible to unauthorized persons.

2. For low dose rate afterloader devices which will be used in multiple rooms within a single building, a description of the following is required:

(a) Methods for providing security and surveillance of the patient room.

(b) Restricted area controls (e.g., signs.and entrance '

controls) for both the treatment and storage rooms, including the sign location, sizes and wording (also see V.H.).

(c) The proposed storage area for the device when not in use. 1 (d) Method to ensure that whenever the afterloader device FC 86-4, Rev.1 8

is not in use or is unattended, the console keys will be inaccessible to unauthorized persons.

E. The licensee must confirm that a permanent radiation monitor capable of continuously monitoring the source status will be installed in each dedicated treatment room for high, pulsed and medium dose rate devices. The licensee must confirm that the proposed monitoring system includes the features described below and commit to performing the specific checks discussed below.

1. The radiation monitor will provide visible notice of an afterloader device malfunction that results in an exposed or partially exposed source, and must be observable by an individual entering the room.
2. The radiation monitor will be equipped with a backup power supply separate from the power supply to the afterloader device (may be a battery system).
3. The radiation monitor will be checked with a dedicated check source for proper operation each day before the afterloader device is used. A record of the radiation' monitor check described above will be sqaintained for a period of three years. The operability check will be performed and >

l documented in accordance with Section VIII, Item B.3(a).

p. If a radiation monitor is found inoperable, the licensee will require any individual entering the treatment room to j

use a survey instrument to monitor for any malfunction of

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the source exposure mechanism that may re:, ult in an exposed or partially exposed source. The survey instrument will be checked with a dedicated check source for proper operation at the beginning of each day of use.

5. The licensre will promptly repair or replace a radiation monitor that is found to be either inoperable or evidences (

intermittent problems. l F. The licensee must submit detailed calculations of maximum radiation levels (and dose rates) that will exist in each area, ,

restricted and unrestricted, adjacent to the room (s) where l treatment is performed using an afterloading device to demonstrate compliance with 10 CFR 20.1301. (This includes areas above and '

below the treatment room.) For programs authorizing the use of a low dose rate afterloading device in multiple rooms, the licensee must perform the calculations using one or more room l configurations which are representative of those in which patient j therapies will be performed. The calculations must include the j following: ,

I FC 86-4, Rev.1 l

9 l

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Expected radiation levels for each area adjacent to the room pl. housing the afterloader device considering the most adverse source orientations and maximum source activity to be used in the device. For low dose rate afterloading devices which may be used in multiple rooms and with varied treatment times and source combinations, the calculation (s) should consider the most adverse conditions to be encountered (i.e., maximum source strength or combination of sources used for treatment, source orientation, and room size and layout). The licensee may need to perform several calculations for low dose rate afterloading devices if the device will be used in rooms which are not similar in layout or if the licensee anticipates using varied combinations of sources and/or source strengths.

These calculations must be sufficient to demonstrate that the expected dose rates in restricted and unrestricted areas adjacent to the treatment room (s), meet the requirement of 10 CFR Parts 20.1201 and 20.1301.

2. All parameters used to perform the calculations described above must be specified. These parameters should include g such factors as distance to each area of concern, the type and thickness of material (s) used in barriers and shields, and the transmission factor of the barriers or shields, and the maximum source strength. For low dose remote afterloading devices, the licensee should specify the 1

- configuration of portable shields, if applicable, used for each set of calculations and the source or source combination.

3. The maximum anticipated workload data, such as maximum "on time" per hour and per week for remote a#terloading units which will be used in a dedicated room and occupancy factors used for all adjacent areas. For low dose rate units which may be used in multiple rooms, under varied treatment programs, a profile of the licensee's anticipated workload should be provided with representative examples of treatment times, source combinations and occupancy factors for adjacent areas.
4. Calculations to determine the dose received by individuals present in unrestricted areas should consider continuous occupancy (i.e., occupancy factor of one) unless the i licensee can make a compelling argument for using a lower l value. Calculations to determine the dose received by ,

ancillary staff providing patient care during treatment with low dose rate afterloading devices must include full details of the occupancy factors used.

FC 86-4, Rev.1 l

10

5. Results of the calculations are to be expressed in units of rem (or millisieverts) in any one hour or year, as appropriate.
6. The licensee must demonstrate that the' limits specified in 10 CFR 20.1301(a) will not be exceeded. If the licensee's calculations demonstrate that these limits cannot be met, the licensee must be requested to outline further steps which will be taken to limit exposure to individual members of the public. Options which may be considered by the licensee include:

(a) Adding shielding to the barrier in question, with corresponding modification of the facility description if necessary.

(b) Request an exemption and demonstrate that the requirements of 10 CFR 20.1301(c) will be met. The licensee must demonstrate the need for and the expected duration of operations which will result in an individual dose in excess of the limits specified in 10 CFR 20.1301(a). A program to assess and control dose within the 0.5 rem (5 mSv) annual limit and procedures to be followed to maintain the dose as low as is reasonably achievable must be developed and submitted for review.

[G. The licensee must confirm that it will implement a survey program to demonstrate compliance with 10 CFR 20.1301 and submit a l

descrintion of the oroorams The program should include requirements for conducting surveys following source replacement in medium and high dose rate afterloading devices used in a i dedicated treatment room and when the device location changes from  !

conditions existing during previous surveys. For low dose rate afterloading devices, the program should include requirements for conducting surveys following source replacement or loading of any additional sources. Survey programs for low dose rate afterloading devices may include surveys described in Section V.B.

At a minimum. the survey program must be sufficient to confirm the

__ following:

1. Maximum radiation levels at 10 centimeters from the nearest accessible surface surrounding the main source safe of the afterloader shall not exceed 1 mil 11 roentgen per hour with the source in the shielded position.
2. Radiation levels in restricted areas accessible to radiation workers are not likely to cause personnel exposure in excess of the limits specified in 10 CFR 20.1201.
3. Radiation levels in unrestricted areas will not result in a  ;

FC 86-4, Rev.1 11

i dose to any member of the public in excess of the limits specified in 10 CFR 20.1301.

,A- 4. Records of survey results will be maintained for inspection by the Commission for the duration of the license.

H. The licensee must confirm that conspicuous, durable labels stating

" CAUTION RADIDACTIVE MATERIAL," or the equivalent, will be affixed to at least one outer surface of the device as specified in 10 CFR 20.1904.

VI. Personnel Monitoring The licensee must confirm that pursuant to 10 CFR 20.1502, personnel involved with treating patients using a remote afterloading device will be monitored as appropriate, including whole body badges to be worn by persons entering the restricted area.

VII. Survey Instruments The licensee must confirm the possession and availability of a portable radiation detection survey instrument and a portable radiation measurement survey instrument in accordance with 10 CFR 35.420. The instruments must be available to device operators and ancillary personnel at all times when an afterloading device is in use. To satisfy the requirement to maintain operable survey instruments, the licensee must confirm that the requirements specified in 10 CFR 35.51 will be met. The requirements of 10 CFR 35.51 are as follows:

A. A licensee shall calibrate the survey instruments used to show compliance with this part before first use, annually, and following repair. The licensee shall. i i

Calibrate all scales with readings up to 1000 millirem per I 1.

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.

B. When calibrating a survey instrument, the licensee shall consider

- a point as calibrated if the indicated exposure rate differs from the calculated exposure rate by not more than 20 percent, and shall conspicuously attach a correction chart or graph to the instrument.

C. A licensee shall check each survey instrument for proper operation FC 86-4, Rev.1 12

with the dedicated check source each day of use. 'A licensee is not required to keep records of these checks.

D. A licensee shall retain a record of each survey instrument calibration for three 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 factors deduced from the calibration data, and the signature of the individual who performed the calibration.

VIII. Operating and Calibration Procedures The licensee must provide a copy of operating procedures which, at gA. a minimum, include tne following commitments.

1. Copies of operating procedures will be provided to appropriate staff and one copy will be maintained at the afterloading device console. Operating procedures may be updated and revised without NRC approval provided that such revisions do not relax restrictiveness or degrade safety.
2. Operating procedures will include steps to ensure that the following requirements are met:

(a) A remote afterloading device, console, and treatment or storage room will be secured when unattended.

(b) Only the patient will be in the treatment room during activation of pulsed, medium, and high dose rate afterloading devices. He patient is allo 4 VisitorsWth e ween treatment fractions with a pulsed dose rate afterloader or during low dose rate t7eatments, written procedures shall be established to insure the source is retracted into the shielded safe rior to permitting the entry of any visitor (s) into e treatment room. The maximum number and lenath of

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vis M W will be charted. J (c) Nursing personnel must follow the authorized user's and radiation safety officer's specific instructions regarding care to be provided to a patient during treatments performed using low or pulsed dose rate afterloading devices. If the treatment is to be conducted over a period of several hours and direct patient care will be required, such instructions will be provided to the nursing staff in writing. Nursing FC 86-4, Rev.1 13

personnel will also be provided documented instruction on how to maintain radiation exposures ALARA when providing patient care and, if personnel trained in the operation of the remote afterloader, are not continuously present during the treatment, then the nursing personnel must also be trained in the recognition of, and response to, abnormal device operation or conditions. 1 (d) Treatment planning computer systems utilizing removable media to store each patient's treatment

' ' [ parameters for direct transfer to the treatment system will have each card labelled with the corresponding patient's name and identification number. Such media may be reused (and must be relabelled) in accordance with the manufacturer's instructions.

(e) Immediately after each use of the afterloading device, a survey of the device and oatient will be performed '

to ensure that the source (s) has (have) been returned to the fully shielded position. The survey should include connectors and applicator apparatus, the full length of the catheter guide tube, and the external surface of the device to ensure that the source is fully retracted. The patient shall be surveyed over the body surface near the treatment site prior to removing the patient from the treatment room. For surveys associated with treatments using a medium, high, or pulsed dose rate afterleading device, the survey instrument must be capable of measuring dose rates of 1 - 1000 millirem per hour. For treatments performed using low dose rate afterloading devices in a patient room, the survey must be performed prior to relocating the patient or portable shielding used during treatment, at the end of treatment or each fraction of treatment and after any interruption of treatment.

(f) A record of the survey described in Item 2(e) above will be maintained for a period of three years. The record must contain the date of survey, identification

,/ of the afterloading device (model and serial number),

A identification of the patient, identification of the instrument used to conduct the survey (make, model, and serial number), a representative background dose rate, the survey results, and the initials of the individual performing the survey. l (g) A commitment from the licensee that if the survey specified above in Item 2(e) indicates that the source is not fully retracted to a shielded position in the FC 86-4, Rev.1 14 I

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device, personnel will immediately implement the licenste's applicable emergency procedures.

'y (h) A commitment from the licensee that it shall not conduct any treatment procedure for which a decoupled or jammed source cannot be removed expeditiously from the patient and placed in a shielded container, as determined by the authorized user with consultation by the radiation safety officer or medical physicist.

During all patient treatments using a medium or high

,$- (i) dose rate afterloading device, both the authorized user and either the medical physicist or radiation safety officer must be physically present. Physical presence, for this purpose, is defined as within audible range of normal human speech. To satisfy the requirement for ensuring adequate control of the source during patient treatments using a pulsed dose rate remote afterloading device, the licensee must comply with the requirement described above or submit alternative procedures for NRC review.

(j) During patient treatments using a low dose rate afterloading device over a period of several hours, a device operator trained in the licensee's emergency procedures must be physically present at the licensee's facility or available by telephone in an "on-call" status when not physically present at the facility. The medical physicist or radiation safety officer and the authorized user must be available for prompt assistance in the event that a source appears to have decoupled or becomes jammed in the catheter guide tube. The authorized user and medical physicist or radiation safety officer must be immediately notified of any problems encountered during a treatment. Device operators will follow the instructions of the authorized user and medical physicist / radiation safety officer and implement the licensee's emergency procedures as necessary.

The licensee must confirm, that as a minimum, the following safety kB. checks will be performed and that written, as well as verbal, instruction will be provided to individuals assigned to complete the checks. A description of the method use to perform the following checks must be submitted for review. Procedures should be submitted where indicated:

1. At the beginning of each day of use, the following checks will be performed in accordance with the manufacturer's instructions:

FC 86-4, Rev.1 15

(a) For dedicated treatment rooms, the permanent radiation monitor will be checked with a dedicated check source for proper operation.

-(b) If a dedicated treatment room relies upon a TV monitor to maintain constant observation, the TV monitor will l be checked to verify proper _ operation. Intercom systems installed in dedicated treatment rooms will be checked to verify proper operation.

(c) Treatment console operational function check, test of all indicator lamps other status and operational displays, and, if appropriate, printer test.

(d) Source status indicators (" safe" or " unsafe'),

including those which are integral to the afterloading-device as well as any additional indicators installed at the treatment console or room entrance, will be checked using a dedicated check source (the afterloading device may be used) to verify proper operation.

(e) Electrical interlocks installed at each entrance to a dedicated treatment room for high and medium dose rate device will be tested for proper operation (See V.D.1.(d)).- Records of each test will be maintained for a period of three years and will include the date of the test, the results of the test, and the initials of the individual who performed the test.

(f) The mechanical integrity of all applicators, source guide tubes, and connectors to be used shall be determined by visual inspection and/or radiographs.

The presence and correct placement of any internal shields and other essential internal components shall be determined.

(g) A record of these checks will be maintained for a period of three years and will include the date of the check, the results of the check, and the initials of the individual who performed the check.

2. Prior to use, the following checks will be performed in accordance with the mancfacturer's instructions, within the

. proceeding 30 days: .

(a) The afterloading device will be tested to determine the acc.uracy of source positioning. Source positioning within the catheter guide tube should be accurate to within +/- 1 millimeter of the programed position. A record of the test will be maintained and j FC 86-4, Rev.1 16 {

9 will include the date of the test, the programmed position, the actual position of the source following activation of tr.e device, and the initials of the individual who performed the test. (This record may include the radiograph used to determine source position.) If the source position tolerance noted above (+/- 1 mm) is exceeded, the authorized user and radiation safety officer must be notified prior to performing patient treatments. The licensee should submit the procedure describing the. test and specify the number of dwell positions used to conduct the test.

(b) Timer accuracy and linearity.

(c) For devices that use a cable and/or wire to transport the source (s), measurement of source guide tubes to confirm the length to 1 mm accuracy.

(d) The backup battery for the remote afterloading device will be tested, in accordance with the manufacturer's instructions, to verify emergency source retraction capability upon power failure. At a minimum, this shall consist of function test with the AC power disconnected.

(e) A record of these checks will be maintained for a period of three years and will include the date of.the check, the results of the check, and the initials of the individual who performed the check.

C. The licensee must develop and implement procedures governing calibration of the afterloading device. The procedures should be approved by the licensee's authorized physicist (s) and must be submitted for review. At a minimum, the calibration procedures must address the following:

1. Calibration measurements of the remote afterloading device source (s) must be performed by the licensee's authorized physicist (s). The licensee should provide information about the individual's experience in the use of dosimetry systems necessary to perform the calibration measurements. The licensee must confirm that the individual (s) performing calibration measurements will complete all measurements and calculations in accordance with the procedures established by the licensee's authorized physicist.
2. The method used to determine the exposure rate under specific criteria (i.e., distances used for the measurement, whether the measurement is an "in-air" measurement or done using a phantom, configuration of the chamber with respect FC 86-4, Rev.1 17

to the source guide tube and device, scatter factors used to compute the exposure rate, etc.).

3. Record maintenance requirements, including a commitment to maintain a record of calibration measurements and associated calculations for a period of three years. The records must include the manufacturer's name, model number, and serial number for both the afterloading device and source; the manufacturer's name, model number and serial number of the instrument used to measure the output of the afterloading device, the date that the calibration measurement was performed, and the name of the individual who performed the measurement. The record must also include the output of the device expressed in centigray (rads) per hour or, if appropriate, sieverts (ress) per hour and a comparison of manufacturer's .:" expected") output value (corrected for decay).

The " expected" and measured output values should be within

+/- 5 percent. If the measured value differs by more than 5 percent of the expected value, the licensee must commit to having the results reviewed by their radiation safety officer or medical physicist prior to performing further patient treatments.

4. A description of the dosimetry system which will be used to perform calibration measurements must be submitted with the procedures. The licensee must also confirm that the dosimetry system (e.g., Farmer chamber, electrometer, etc.)

will be calibrated by a laboratory accredited by NIST or AAPM within the previous two years and after any servicing that may have affected system calibration. The licensee should confirm that records of such calibrations will be maintained for inspection.

5. The frequency for calibration measurements must be specified. It is required that calibrations be performed following installation of a new source (s) before patient treatment is resumed, and recommended monthly thereafter.
6. The procedures must include a description of the method to be used to confirm source homogeneity for each source contained in the afterloading device. This may be done by autoradiography, following source replacement but prior to using the source (s) for patient treatment.

D. The licensee must describe the method (s) it plans to use for conducting inventories of the source (s) contained in afterloading device (s). To obtain compliance with 10 CFR 35.59, the licensee must confirm that physical inventories will be conducted quarterly and that records of the inventories will be maintained in FC 86-4, Rev.1 18

accordance with 10 CFR 35.59(g). To meet this requirement, it is recomended that an autoradiograph be obtained of the source, or set of sources, contained in the afterloading device.

IX. Emergency Procedures A. The licensee must submit for review the emergency procedures approved by the authorized user (s) and radiation safety officer or medical physicist. The licensee must confirm that copies of the procedures will be provided to device operators, authorized user (s), and other personnel as necessary. In addition, a copy of the procedure must be posted at the afterloading device console or .

in a conspicuous location at the treatment area.

B. At a minimum, the procedures should address the following:

1. Specify when the procedures are to be implemented, such as, any circumstance under which the source cannot be retracted to a fully shielded position in the afterloading device.
2. The actions specified for emergency source removal should give primary consideration to minimizing exposure to the patient and healthcare personnel while maximizing safety of the patient. I
3. Specify step-by-step actions for single or multiple equipment failures that specify the individual (s) responsible for implementing the actions. The procedures should clearly specify which steps are to be taken under different scenarios (i.e., source decoupling versus a jammed source) The procedure should specify situations when surgical intervention may be necessary and the steps which must be taken in the event that surgical intervention is required.
4. For low dose rate procedures only, a requirement that the authorized user and the medical physicist or radiation safety officer be notified immediately of any problem requiring implementation of emergency procedures to include a commitment to post the names and on-duty and off-duty telephone numbers of these individuals at the operating console of the device. (These individuals are required to be present for pulsed , high- and medium-dose rate procedures.)
5. Requirements to restrict and post the treatment area wit,h appropriate signs to minimize the risk of inadvertent exposure of personnel not directly involved in emergency source recovery.
6. Identify the location of emergency source recovery equipment FC 86-4, Rev.)

19

/

9 and specify what equipment may be necessary for the various equipment failures described in the procedure. At a minimum, emergency equipment should include shielded storage containers, remote handling tools, and, if appropriate, supplies necessary to surgically remove applicators or

' sources from the patient, including scissors and cable cutters.

X. Maintenance A. The licensee must confirm that only personnel who are licensed by the Commission or an Agreement State to perform such services will perform maintenance and repair on the afterloading device.

Maintenance and repair includes installation, replacement, relocation or removal of the sealed source or an afterloading device that contains a sealed source. Maintenance and repair also means any adjustment involving any mechanism on the afterloading device, treatment console, or interlocks that could expose the source, reduce the shielding around the source, or affect the source drive controls. (A licensee authorized for a low dose rate afterloading device designed as a " mobile" unit may relocate the device for patient treatment if authorized to use the device in multiple rooms.)

The licensee must confirm that a record of any maintenance and repair performed on the afterloading device will be maintained for the duration that the device is in use and must include the date of repair, a description of the nature of the maintenance or the repair, the name of the individual who performed the repair, Agreement State or NRC license number authorizing the individual to perform such repairs, and the signature of the individual who performed the repairs.

B. The licensee must confirm that the following requirements are met for inspection and service of remote afterloading devices.

1. Each afterloading device will be fully inspected and serviced at intervals not to exceed one year, to ensure proper functioning of the source exposure mechanism. In addition, the licensee must confirm that scheduled service recommended by the manufacturer will be performed in l I

accordance with the manufacturer's instructions.

2. Inspection and service will only be performed by the manufacturer or other persons specifically licensed to do so by the Commission or an Agreement State.
3. Records of inspection and service will be maintained for the duration of the license and will include the date of the inspection / service, the name of the individual who performed the inspection / service, the Agreement State or NRC license FC 86-4, Rev.1 l l

20 l

s number authorizing the individual to perforin inspection / service, a description of the nature of the inspection / service including a list of the components inspected and a list of components serviced or replaced, and the signature of the inspector.

C. The licensee may request that an employee trained by the .

manufacturer be authorized to perform maintenance and repair

functions. Such authorization should list the employee by name and specify only those maintenance and repair functions described in a certificate or letter from the manufacturer of the device which documents the training and an outline of the training. A copy of the training certification and an outline of the training provided is to be submitted with the request.

XI. Waste Disposal The licensee must confirm that the source (s) will be disposed of only by return to an authorized recipient, such as the source / device manufacturer.

FC 86-4, Rev.1 21

ATTACHMENT 1 MEDICAL USE APPLICATION CHECKLIST REMOTE AFTERLOADING BRACHYTHERAPY DEVICES NOTE: The attached checklist does not reference detailed information contained in Regulatory Guide 10.8, Revision 2, for calibration of survey instruments, radiation safety committee membership or responsibilities, personnel monitoring program, leak testing program, and ALARA program. The license reviewer should consider any of the aforementioned programs as part of the review to meet the needs of a brachytherapy program involving remote afterloading devices. The licensee should be requested to respond to any deficiency in these areas as well as any deficiency identified using this checklist.

t 4

FC 86-4, Rev. 1

ATTACHMENT I 4

MEDICAL USE APPLICATION CHECKLIST REMOTE AFTERLOADING BRACHYTHERAPY DEVICES (Checklist Should 8e Placed In License File)

1. NAME & ADDRESS OF APPLICANT:

License No.:

Docket No.:

Control No.:

O YES O NO QUALITY MANAGEMENT PROGRAM ON FILE i QM Program addresses remote after- O YES O No loading brachytherapy Notification of QM Program change O YES O NO O NA Training in QM Program provided as O YES O NO  !

required in 10 CFR 35.25 l 1

Negative responses require submission by the licensee of I NOTE:

required QM Program changes or committments prior to issuance of the licensee or amendment.

2. LOCATION OF USE:(No P.O. Box Address)

Street address City State NOTE: If mobile or multiple sites are requested, refer application to IMNS

3. INDIVIDUAL TO CONTACT CONCERNING THE APPLICATION i Name:

Title:

Telephone No.:

4. BYPRODUCT MATERIAL Source Description Radionuclide(s) Activity (Ci)

Manufacturer & Model Number (s) l Listed in " Registry of Sealed Sources and Devices" U YES U NO If the source is listed in the registry, list the reference number here:

FC 86-4, Rev. I 1 I

l

f, -

~ Medical UseL Checklist.

Remote Afterloading Devices Number of Sources Maximum Activity (Ci).

Radionuclide/Model Number Number of sources per Source Model 1,

2.

3.

Depleted Uranium O YES O NO Source Safe Source Container (s)

Kilograms Device Description Manufacturer & Model Name & Humber(s):

Listed in " Registry of Sealed Sources and Devices" C YES O NO Device Type: LDR O MDR O HDR O

  • Pulsed O
  • Mobile Service *
  • Refer to Headquarters
5. INTENDED USE

-0 Interstitial / Intracavitary O Intraluminal O Human only 0 Other ,_

6. AUTHORIZED USERS A. PHYSICIANS Name .

Training & Experience Meets

, or Broad Scope

1. 10 CFR 35.940 O YES (a) or (b)O NO
2. O YES O N0
3. O YES O NO B. PHYSICIST (S)

Name Training & Experience Meets 10 CFR 35.961, or Broad Scope

1. O YES O NO (Refer to HQ) 2., __ O YES O N0 (Refer to HQ)
3. O YES O NO (Refer to HQ)

FC 86-4, Rev. 1 2

Medical.Use Check 11st Remote Afterloading Devices

7. . TRAINING PROGRAM O- Authorized Users and Device Operators O Subjects.to be included in initial training O " Hands on" operation training O Trained operators present during use O Annual retraining O Subjects to be include in retraining O " Hands on" emergency procedure implementation O Instructors - Initial Training O Name, affiliation, qualifications O Experience with afterloading device (s) .

O Ancillary Personnel O Subjects to be included in training for low or pulsed dose rate  :

program O use of survey instruments for nursing staff O Consistent with 10 CFR 35.410 O Annual refresher training O Records maintained

8. FACILITIES ,

O Dedicated Room (High, Pulsed, and Medium Dose Rate) 1 O Annotated Drawing )

O Scale O Room numbers (Room Identification) i O Shielding material O Adjacent areas; restricted / unrestricted; includ.e areas above and below the treatment room O Viewing System and Intercom ,

O Primary 4 {

O Backup j O Provision if primary system fails without backup I

C Access control O Electric 41 Interlock D . System operation  !

O Response to interruption O Commitraent to suspend treatment if interlock m41 functions O Arou controls (signs, locks, visible / audible alarms)

L 0 0ther radiation-producing devices

.FC 86-4, Rev. 1 3 L

D

l l

Medical Use Checklist I Remote Afterloading Devices 1

-O Method to prevent dual operation O Security of console keys O Permanent radiation monitor l 0 Visible notice on entry l 0 Back-up power supply i O Operability check O Emergency entry provisions O Commitment to promptly repair / replace O Multiple Rooms (Low dose rate devices only)

O Portable shields O Verification of shield position during treatment O Survey of adjacent areas and record retention l C Provisions for patient and device observation .

/ O Access control ,

i O Area controls (signs, locks, ahrms) d C Provisions for storage of Jevice when not in use O Security of console keys

9. COMPLIANCE WITH RESTRICTED / UNRESTRICTED AREA RADIATION LEVEL LIMITS 1

O Calculations of maximum radiation levels for I

, restricted / unrestricted areas to demonstrate compliance with 10 l CFR 20.1201 and 20.2301 l O Parameters used to calculate radiation levels (Source strength, shielding materials, room configuration, etc.) ,

O Anticipated workload data, occupancy factors l

[] Dose calculations for individuals in restricted and  ;

unrestricted areas O Dose levels comply with 10 CFR 20.1201 and 20.1301 1 O Exemption from 10 CFR 20.1301 requested O Need for exemption specified O Duration of exemption specified O Program to assess and control dose O Survey program to demonstrate compliance with 10 CFR 20.15C1 O Survey of. device following source replacement or location  !

of device changes.

O Device labeled in accordance with 10 CFR 20.1904 FC 86-4, Rev.-.1 4 i

Medical Use Checklist . .

Remote Afterloading Devices

10. PERSONNEL MONITORING O Personnel dosimetry provided to apprcpriate personnel in compliance with 10 CFR 20.1502
11. SURVEY INSTRUMENTS O Survey instruments satisfy 10 CFR 35.420 O' Daily operability checks O Calibration performed annually in accordance with 10 CFR 35.51 O Records of calibrations maintained in accordance'with 10 CFR 35.51
12. OPERATING PROCE0dRES O Commitment to provide copies to device operators and post copies at device console O Commitment to provide verbal, as well as written instruction to -

individuals providing safety checks O Procedures submitted include following comitments:

O Device, console, and treatment room secured whe. n not in use or unattended O Only patient allowed in treatment room for medium /high dose rate afterloading device O When visitors are allowed for low and pulsed dose rate treatments, procedures shall be established to insure the source is retracted into the shielded safe prior to entry of the visitor (s) into the room and the maximum number and length of visits allowed shall be charted O Nursing personnel provided specific (written) instructions for patient care O Computer media used to load patient treatment parameters prop 2rly labeled, reused in accordance with manufacturer's instructions O Survey of device and patient performed imediatelv following source r& traction or removal (See VIII. A. 2.(e))

3 O Record of device and patient surveys maintained O Comitment to implement emergency procedures if source not fully retracted -

O Commitment not to conduct treatments for which a decouple or Jamed source could not be removed expeditiously O Authorized user and medical physicist or radiation safety officer present during all treatmnts using a medium, pulsed, or high dose rate afterloading device FC 86-4, Rev. 1 5

Medical Use Checklist Remote Afterloading Devices 0 Authorized user and medical physicist or radiation safety officer present during all treatments using a pulsed dose rate afterloading device or alternative commitment to provide equivalent safety controls O Device operator present or available by. telephone during treatments with low dose afterloading device, authorized user and medical physicist:or radiation safety officer available for assistance O Daily Checks - descriptions submitted O Permanent radiation monitor tested with dedicated check source i O Viewing and intercom systems checked for operability prior to use O Source position indicators checked for operability 0 Treatment console operational function check and test of all indicators (lamps) and. displays O Visual and/or autoradiographic inspection of applicators and connectors 0 Test of electrical i'nterlocks for operability, records of test maintained O- Commitment to suspend treatments if interlock system l malfunctions O . Record of daily checks maintained O Monthly Safety Checks - descriptions submitted 1

O Backup battery check for afterloading device O Source positioning accuracy checked i O Source positioning accuracy to within +/- I mm I O Procedure submitted O Timer accuracy and linearity O Measurement of source guide tubes and connectors O Records maintained.

O Calibration of afterloading device

'O Names and qualifications of individuals performing calibrations 0 Experience with dosimetry system O Description of the method used to determine exposure rate O Record of calibration maintained and content D. Notification of radiation safety office or medical physicist if measured output differs by greater than 5% of expected value

.O Dosimetry system O- Calibrated by NIST/AAPM-approved lab at 2 year intervals O Calibration record maintained

'FC 86-4, Rev.:1- 6

Medical Use Checklist Remote Afterloading Devices O Calibration frequency - following source replacement and monthly thereafter O Determination of source homogeneity O Method for conducting source inventories in accordance with 10 CFR 35.59 (autoradiography, source replacement, etc.)

13. EMERGENCY PROCEDURES O Established by authorized user and RSO or medical physicist, posted at treatment console / area O Specify when to implement procedures O Confirmation copies of procedures provided to device operators O Actions specified for emergency source removal O Step-by-step actions for progressive equipment failures, specific instructions on which steps may be applicable for given circumstances and who will perform these actions O Requirement to notify authorized user and medical physicist or RSO immediately of any problem requiring implementation O Appropriate telephone numbers posted O Instructions for restricting and posting area O Emergency source recovery equipment
14. MAINTFNANCE O Performed only by manufacturer's representatives or individuals specifically authorized by NRC or Agreement State j O Records maintained for all maintenance and repair <

0 Afterloading device inspected and serviced at least annually 0 Inspections performed only by individuals authorized by NRC or Agreement states O Records of inspections maintained O Licensee employee authorized to perform device maintenance and repair O Has letter or certifics.te from manufacturer documenting '

training O Letter or certificate specifies those functions which the named ,

individual is qualified to perform

15. WASTE DISPOSAL O Transferred only to authorized recipient (manufacturer)

FC 86-4, Rev. 1 7

1 1

l ATTACHMENT 2 l STANDARD LICENSE CONDITIONS FOR REh0TE AFTERLOADING BRACHYTHERAPY DEVICES The following license conditions always apply to use of remote afterloading brachytherapy devices. Some of the conditions listed below apply only to the use of medium and high dose rate afterloading devices as indicated below.

General Conditions for All Remote Afterloadina Brachytheraov Devices l

  • In lieu of 10 CFR 35.404(a), immediately after retracting the source (s) from the patient into its shielded position in the remote afterloading device, a radiation survey shall be made of the patient and the remote afterloading device with a portable radiation detection survey instrument to confirm that the source (s) has been removed from the patient. Records of the survey shall be maintained in lieu of the record required in 10 CFR 35.404(b).
  • In lieu of the source inventory required in 10 CFR 35.406, the licensee shall:

A. Promptly determine that all sources have returned to the safe, l shielded position at the conclusion of each remote afterloading  !

brachytherapy procedure.

B. Promptly make a survey of the area of use to confirm that no sources have been misplaced.

C. Make a record of the survey including the survey instrument used, dose rate expressed in mrem /hr (pSieverts/hr), time, date and name of the individual making the survey. j D. Retain the record of the survey in lieu of the record required in 10 CFR 35.406(d).

  • The following shall be performed only by manufacturer's representatives j or persons specifically authorized by the Commission or an Agreement (

State to perform such services: ,

A. Installation and replacement of the sealed sources contained in remote afterloading brachytherapy device (s).  !

B. Any maintenance or repair operations on remote afterloading brachytherapy device (s) listed in Item 9, Subitem (s), involving l l

work on the source safe, the source drive unit, or other mechanism that could expose the source, reduce the shielding around the source, or compromise the safety of the unit and result in i increased radiation levels.

1 FC 86-4, Rev. I 1 1

l l

l

Standard License Conditions a Prior to initiation of a treatment program and subsequent to each source exchange, using remote afterloading brachytherapy devices, radiation surveys and tests shall be performed in accordance with the following:

A. A radiation survey shall be made of:

(1) The afterloader source housing, with the source in the shielded position. The maximum radiation levels at 10 centimeters from the nearest accessible surface of the main source safe shall not exceed 1 mil 11 roentgen per hour.

(2) All areas adjacent to the treatment room with the-source in the " irradiation" position. The survey shall clearly establish:

(a) That radiation levels in restricted areas are not likely to cause personnel exposure in excess of the limits -

specified in-10 CFR 20.101 (10 CFR 20.1201).

(b) That radiation levels in unrestricted areas do not exceed the limits specified in 10 CFR 20.105(b) (10 CFR 20.1301).

Pulsed . Medium . and Hich-Dose Rate Remote Afterloadina Devices

. Access to the room housing the afterloading brachytherapy device shall f be controlled by a door at each entrance.

A. The entrance to the irradiation room shall be equipped with an electrical interlock system that will cause the source to return to the shielded position immediately upon opening of the entrance

. door. The interlock system shall be connected in such a manner that the source cannot be placed in the irradiation position until the entrance door is closed and the source "on-off" control is reset at the control panel.

B. Electrical interlocks on the entrance door to the irradiator room shall be tested for proper operation at least once each' day of use. Records of test results shall be maintained for inspection by the Commission for a period of three years.

C. In the event of malfunction of the door interlock, the remote afterloading brachytherapy device shall be locked in the "off" position and not used, except as may be necessary for repair or replacement of the interlock system, until the interlock system is shown to be functioning properly.

FC 86-4, Rev. 1 2

I i

ATTACHMENT 3 INDEX OF APPLICABILITY FOR P&GD 86-4 (Rev. 1)

This index lists the body of P&GD 86-4 in outline form and indicates for each section of the directive whether it applies to all remote afterloaders (All), only low dose-rate devices (LDR), or high dose-rate devices (HDR). HDR indicates that the section applies not only to HDR's but, also, to Pulsed- and Medium-dose rate devices.

I. Description of the Source (s) and Device (s)

A. All

1. All
2. All  ;
3. All
4. All S. All B. All
1. All
2. All II. Intended Use III. Proposed Users A. All
1. All
2. All '
3. All
4. All B. All
1. All
2. All
3. All IV. Training for Individuals A. All
1. All
2. All
3. All B. All C. All D. All FC B6-4, Rev. 1 1

'E. All F. All V. Facilities A. HDR

1. HDR-
2. HDR-
3. HDR
4. HDR
5. HDR B. LOR
1. LDR
2. LDR
3. LDR C. HDR
1. HDR
2. HDR

. D. All

1. HDR 1 (a) HDR (b) HDR (c) HDR (d) HDR (e) HDR (f) HDR

! (g) HDR 1

2. LDR (a) LDR (5) LDR I (c) LDR (d) LDR E. HDR
1. HDR
2. HDR
3. HDR
4. HDR
5. HDR

.F. All

.l. All

2. All
3. All
4. All
5. All
6. All (a) ~

FC 86-4, Rev. I 2

(b)

G. All

1. All
2. All
3. All
4. -All H. All VI. Personnel Monitoring - All VII. Survey Instruments A. All
1. All
2. All
3. All B. All C. All D. All
1. All
2. All VIII. Operating and Calibration Procedures A. All
1. All
2. All (a) All (b) All (c) All (d) All (e) All (f) All (g) All (h) HDR (i) HDR (j) LDR B. All
1. All

-(a)' All (b) All (c) All (d) All (e) All (f) All (g) All FC 86-4, Rev. I 3 s-

2. All (a) All (b) All (c) All (d) All (e) All C. All
1. All
2. All
3. All
4. All
5. All
6. All D. All <

IX. Emergency Procedures A. All B. HDR

1. All
2. All
3. All
4. LDR
5. All
6. HDR X. Maintenance A. All l

, B. All

1. All
2. All
3. All C. All XI. Waste Disposal FC 86-4, Rev. 1 4

4 ma ase og e i UNITED STATES j

f j NUCLEAR REGULATORY COMMISSION WASHINGTON D.C. 20ess.4001 k.....,/ March 13, 1995 MEMORANDUM T0: Those on Attached List FROM: Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety, NMSS

SUBJECT:

ADDENDUM TO DFVISION 1 TO POLICY AND GUIDANCE DIRECTIVE_

IC 86-4. INFORMATION REQUIRED FOR LICENSING REMOTE AFTERLOADING DEVICES - INCREASED SOURCE POSSESSION LIMITS Nucletron recently issued a letter, dated January 20, 1995 (attached), to all users of the Microselectron-high dose rate remote afterloade" (Microselectron-HOR). Nucletron has received a Special Form Certification to allow shipment of microSelectron-HDR sources, manufacturered by Mallinckrodt Diagnostica in Holland, with greater than 10 Curie (C1) activity on the date of shipment.

However, there has been no modification of the sealed source and device registration sheet, which currently limits the source activity in the device to 10 Cf. The letter advises NRC licensees to request a license amendment to authorize a possession limit of 12 Ci per source with the stipulation that no source with activity greater than 10 Ci will be installed by a Nucletron engineer in a remote afterloader. It is anticipated that other vendors may also obtain a Special Form Certification to allow similar shipments.

_The reaiaae may arant tha ==andmant ranua<t nrnvidart that the licensee comm us not to'inct211 the source into the device at'an activity greater than 10 C1. i The installation must be performed by an authorized incividual, as spec 1ried  !

in Section X (Maintenance) of this Policy and Guidance Directive. Licensees are currently required, in part, to perform calibrations following installation of a new source before patient treatment is resumed, and maintain a record of each calibration. This record could be used by NRC inspectors to i verify compliance with the commitment. Furthermore, the licensee must demonstrate that sufficient administrative procedures are in place to ensure I compliance with 10 CFR 20.1801, " Security of stored material." This would l

include, at a minimum, a description of the storage area and individuals with access to the material. The licensee should also provide a copy of the Special Form Certification.

Contact:

Patricia K. Holahan', NMSS (301) 415-7847 l

1 Enclosure 2 UAO@ W______ _ _ _ _ _ _ _ _ _ _ _ _ - _ _ _ _ _ _- _ - - _ - --- - - - -

. . .,3-P

' Those on Attached List 2 l

The following license condition should be used when granting the amendment: l "The licensee may possess 24 Ci iridium-192 (not to exceed 12 Ci per ,

source) for use in the , provided the individual i source activity does not exceed 10 Ci at the time of installation, and  !

the source is installed by an authorized individual."  ;

1 i

Attachment:

Ltr fm STeague dtd 1/20/95 i

[-- . . . . . . . . . ,~,

-~ - --~ '-* **"*

, i MUCIEtron* =c=" """ l

/cBo Columela Gateway Der Columbia, Maryland 21c46 2 Telephoner 41o-312 4100 FAX: 41o.312 4199 ,

)

January 20,1995

. \

l i

Attn: All Redistion Safety Officers RE: UCENSE AMENDMENT - MICROSELECTRON HOR SOURCE POSSESS 10N 1.lMITS Dest Radiation Safety Officer:

Nucletron has recently received Special Form certification for the microSelectron-HDR source i manufactured by Malitnckrodt Diagnosttes in Holland. As a result of this certification, it is l possible to ship microSelectron HOR sources to customers with greater than 10C1 activity on the date of shipment.

Most licensees are limited to possesekm limits of 10Cl per source for the two sources listeg on j the licenst. Te enhance the ability of each licenses to have a 1OCl source Installed in their '

remote afterloader on schedute Nucletron wishes to ship the sources at soproximately 11.5CI l to oech cuetemer prier to the source exchange.

Each licenses must amend their Radioactive Materiais Ucense to authorize a possession limit I of 12Ci per source with the stipulation that no tource greater than IOC) will be installed by a Nucletron engineer in o remote afterfonder. The documents accompanying the source will indleate the Special Form Certification.

After the amendment has been received by the licensee, plasse fax a copy to Nucletron Corporation at 410 312 4197. l Should you have any questiona concerning this letter, plessa contact the undee'signtd directly.

Slacerely, NUCLETRON CORPORATION Stephen T e Teichnical Manager / Radiation Safety Officer Attachment

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