RPPM 6.0 Radiation-Generating Machine Poss. + Use

6.1 Acquisition and Installation of radiation-generating machines

Possession and use of machines capable of creating a radiation exposure risk are regulated and overseen by the WA DOH Office of Radiation Protection
The University is required to pay an annual fee to the State Department of Business licensing for each machine that is in active use at a University facility or that is being used within the State under the authority of the University;
All acquisitions, installations and uses of machines at a University location must be pre-authorized and overseen by the Radiation Safety Committee (RSC) and RSO;
All machines capable of producing ionizing radiation must be supervised by an Authorized User who has been approved by the RSC (see RPPM 3.4.6 and D).
There are no radiation machines operated under the authority of the University that are approved for the exposure of any part of a person to the primary beam (x-ray or particle).

A University department, Authorized User or permanent staff member who is planning to acquire a radiation-generating machine should contact the RSO well in advance of the machine acquisition to obtain specific guidance.
The RSO will provide guidance related to:
Machine acquisition(s);
Authorization application;
Machine facility shielding assessment and machine installations.
A radiation-generating machine must not be purchased or accepted as a gift, donation or transfer without the pre-approval of the URSO and without an RSC-approved Authorization in place.
Plans and specifications for the construction of new facilities or for a modification of an existing facility to house a radiation machine must be reviewed by the RSO, RSC and/or by the WA DOH.
The information that must be provided to the RSO to initiate plan review includes:
The technical specifications of the equipment that is to be acquired and installed;
The facility layout and as-built construction plans plus all installed or planned shielding (location and composition);
Desired/planned machine and beam orientation(s);
Occupancy of adjacent areas, including specific use(s) and number and type of individuals having access to and frequenting adjacent areas during planned machine operation hours;
Summary of proposed operations including operating voltages, beam on times, and expected radiation levels within and immediately outside the controlled area(s).
The RSC may visit a planned machine use location prior to granting a machine Authorization to assess the level of hazard or risk associated with the equipment, installation and/or proposed use.

6.2 Machine Types used for University education (training), research, and service

General machine classifications
Open beam x-ray systems
An open-beam machine has an incomplete or no machine enclosure so that there is access to the primary beam path.
The following design requirements are typical of this type of system:
- Each port of the tube housing is to have a beam shutter interlock which engages the collimator (beam limiting device). The unit only operates with the collimator in place and operating properly;
- A shutter must be in place and secured at an unused port during machine operation;
- All operative shutters have a “shutter open” indicator fail-safe mechanism, whether the high voltage and beam are on or off, and that can be operated remotely;
- A guard device is in place to prevent casual entry of any part of the body into the primary beam.
Closed beam x-ray systems
Represents a machine design in which there is a full enclosure and no access to all possible primary beam paths.
The following design requirements are typical of this type of system:
The inherent shielding of the enclosure walls is sufficient to limit the dose to 0.25 mrem/hr at 5 cm;
The enclosure is interlocked with the X-ray source high voltage supply or a shutter, that prevents the beam from entering the sample chamber while it is open.
Particle Accelerators
Is a device design that uses an electromagnetic field to propel charged particles to high speeds and to produce a well-defined ionizing primary beam.
The machine may be capable of operating in a steady state (continuous beam produced) or may produce a pulsed beam (intermittent radiation produced).
The following design requirements are typical of this type of system:
- Shielding is in place around the device to reduce the radiation hazard in the immediate work area to levels which do not exceed allowable occupational exposure limits;
- Attenuation of the primary beam is accomplished by a reasonable combination of physical shielding and other barriers at a distance from the primary beam;
- Where visual contact with the entire exclusion area can be maintained by the operator, a visual check and audible warning is required before commencing operation;
- Exclusion areas and their entrances are equipped with easily observable flashing or rotating warning lights which operate during any radiation production.
- The primary controls influencing the production of radiation are attended by a trained and authorized radiation worker (operator) whenever an accelerator is operational;
- The controls are secured when unattended in order to prevent unauthorized use;

6.3 Radiation machine facility classifications, security and control

Facility radiation protection classification
Areas where personnel or the general public could be exposed to radiation are classified according to the dose rate(s) generated when the machine is operated at the stated maximum energy (i.e. – kvp, Mev, etc.) and intensity (i.e. – current, amp, flux density, etc.)
The measured exposure rate and ALARA considerations determine the type of area access control that is required and any other required machine use conditions (see Table below);
The RSC or URSO designate the classification of machine facilities and all adjacent areas at the time of Authorization approval, amendment or renewal using: data collected:
During RSO machine and facility radiation exposure surveys;
Over the machine’s life-time of operation (use logs and environmental dosimeter readings).
The RSO monitors ambient dose rates in and adjacent to all new or remodeled facilities where open-beam radiation machine are installed and used.
Only the RSO may make changes to radiation use area facility designations and postings.

Classification of radiation areas; allowed access; and maximum exposure limits.

Area	Area access	Allowable Exposure/hr Limits	** Annual* Limits**
Not controlled	Uncontrolled, not restricted	less than 2.0 mrem in 1 hour	less than 100 mrem/ yr*
Controlled	Restricted* to authorized radiation users + escorted guests	more than 2.0 mrem in 1 hour	100 mrem/yr*
Radiation area	Controlled area posted as a RADIATION AREA ; Only radiation workers listed on the Authorization and required to be present during the operation	more than 5.0 mrem in 1 hour @ 30 cm
High Radiation Area	Controlled posted as HIGH RADIATION AREA; AU or designee with pre-approval of URSO for limited and specific purpose	more than 100 mrem in 1 hour @ 30 cm
Exclusion	No access during equipment operation	Personnel are not permitted the area during equip operation due to high dose rates

*Annual exposure limit implies a potential for exposure over 52 consecutive work weeks.

** Temporary access to controlled areas will be allowed to qualified personnel, with specific conditions and limits in place, when pre-approved by the URSO.

Facility posting and survey requirements
A “Caution Radiation Area” sign and/or warning device is posted at the entrance to all radiation machine facilities (i.e. – rooms or restricted access areas).
The RSO assures that the following posting(s) are conspicuously posted in an area where a machine is operated (i.e. – at the operator’s control console):
A current copy of the Washington State “Notice to Employees”
A copy of the Authorization Machine Cover Sheet.

Security and Access Restriction To Radiation Machines and Facilities
All facilities housing or used for storage of a radiation machine must be secured against unauthorized access;
Access to the restricted area(s) is to be limited by means of physical barriers and shielding devices, and indicated by the posting of the appropriate radiation warning signs.
Security is to be accomplished by locking the power switch, the high voltage supply, or the door to the facility whenever the area is unattneded by an approved and trained operator;
If a unit is left operating when unattended by the approved operator, area security must be accomplished by a means that prevents access to the room, controlled area(s) and machine controls.

6.4 Safety and Operational Guidelines and Requirements for Radiation Machines

6.4.1 General Safety and Operational Protocols

The RSC-approved Authorized User (AU) is responsible for:
Ensuring the machine is operated in compliance with all applicable regulations and the conditions of the Authorization.
The preparation of written operating procedures explaining the use of each radiation machine under his or her control.
Written procedures are to be posted near the operating controls of each machine and are to include:
Safety hazards
Pre-operational safety and machine pre-operation quality assurance protocols
Required operator personal protective equipment (PPE, including dosimetry)
Proper use of built-in safety devices
Proper operation protocol
Required records and their management

Approved Machine Operators
Only a radiation worker listed on the Authorization may be an approved operator or directly supervise the use of a radiation-generating machine;
Approval to be an operator must be contingent on the operator receiving appropriate and specific training on the machine, and demonstrating to the AU, or a trained designee, an adequate knowledge and ability for safe use of the machine;
The Authorization is required to maintain a detailed training log, which includes a written training syllabus prepared by the machine manufacturer and/or by the AU;
The training log is to be maintained and available for inspection at the machine operating console and must list the approved operators, the date and the training specific each operator has completed.

Machine Malfunctions and Emergency Procedures
The AU must prepare and post at the machine control (operator) console:
Written procedure(s) the at the operator is to follow if an emergency situation develops;
An Emergency Response Call list that includes current contact information for University emergency response personnel, the AU and/or the facility supervisor.
- Any unplanned or unexpected exposures (miss-fire) that occur during the routine operation of a radiation machine are to be noted in the use log:
Any subsequent miss-exposure will require immediate cessation use of the machine and the posting of the machine as out-of-service until it can be serviced by a qualified technician;
All machine malfunctions (failure of a machine to perform within the limits of manufacturer specifications) are to be logged in the Machine Performance and Service log;
Servicing and documentation related to performance assessments completed on the machine are required prior to returning the machine to its authorized use;
The RSO considers any equipment that remains out-of-service for more than 12 months to be permanently inactivated and will:
Remove the machine from the Authorization’s list approved use devices;
Remove the machine from the list of machines registered with the WA DOH;
Permanently disabled the machine by the application of a power supply lock-out device, or other mechanical means to assure the machine cannot be operated.
- Operations or occurrences that pose an increased risk of exposure to the operator or any other person(s) during machine operation (i.e. – malfunctioning controls, indicator lights, interlocks, an above-normal radiation exposure) must be identified and logged by the operator and followed by the immediate actions listed:
Safely shut down a machine;
Make an entry into the service log with a note the specific machine operational parameters that resulted in the suspected malfunction;
Post the machine as out-of-service;
Notify the AU or designated supervisor.

Records Management Requirements for Radiation Machines and Facilities
- The AU is to maintain and have available for inspection, the following records:
A copy of the current Authorization;
All approved radiation machine registration forms;
Specific machine operator training logs for all approved machine operators;
A machine use log that includes the date & time, operator name, and applicable machine operating parameters (i.e.- voltage, current, etc.);
Records of routine pre-operational assessments of safety warning lights and interlocks;
A log of all machine malfunctions; repairs; and record of post-repair, pre-operation equipment and facility radiation safety audits and surveys.
- The RSO performs an annual audit and survey of all machine Authorizations; active machines and facilities; and compliance required records;
- The RSO performs a pre-operation inspection on machine(s) and/or facilities if there has been a repair or remodeling performed;
- Machine authorizations are be amended if there is significant change in machine operational protocol(s); workload; or type of use;
- Machine authorizations must be formally renewed by the submission of an up-dated Machine Authorization application form (RPPM 10D and 10E) to the RSC for full review and re-approval at an every 5 year interval.

6.4.2 Specific Machine Type Safety and Operational Protocols

Analytical x-ray machines and devices
General requirements
Regulations do not allow the use of these types of machines without a protective tube housing or shield in place;
The x-ray tube housing contains one or more ports which provide a narrow beam of useful x-rays;
A shutter must be in place for each beam port and must remain closed unless a collimator, camera, or other equipment is attached to the beam port to intercept the primary beam.
Fail safe devices must be in place to assure no exposure the users eyes or skin to the primary x-ray beam due to the risk of severe radiation burns in a matter of seconds.
Additional protective devices should be used on analytical machines whenever possible, and may include:
A combination of filters, cameras, beam enclosures and shielding used to reduce the radiation fields around the equipment;
Filters placed in front of the sample or detectors and which can reduce the intensity of the beam by a factor of from 2 to 6.
Cabinet x-ray machines are systems that have the x-ray tube and the material being irradiated fully enclosed in a cabinet that provides shielding.
These units are equipped with fail safe interlocks to prevent access to the beam during operation.
Other safety methods and devices may be required including:
A key-activated control on the user console that stops disables the machine if the key is removed or not available;
Safety interlocks on each door of a cabinet x-ray system;
Requirement for a control system, other than the safety interlock, that must be engaged to resume x-ray generation following x-ray interruption by a safety interlock;
Two independent means to indicate when the x-ray tube is operating;
One may be a milliamp meter labeled to indicate x-ray tube current;
Another indicator must be an easily seen warning light labeled “X-RAY ON”;
A clearly legible and visible label bearing the statement: “CAUTION: XRAYS PRODUCED WHEN ENERGIZED” that is to present near the controls that energize the x-ray tube.
Portable (hand-held) analytical x-ray devices
All hand-held analytical equipment shall have an interlock system that prevents the operation of the unit unless the x-ray exit port is in contact with or in close proximity to the item being irradiated;
As with all x-ray equipment, the equipment must be:
Operated by a radiation worker listed on the Authorization and trained specifically on the equipment being operated;
Operated in accordance with the manufacturer’s specifications;
If the equipment is used outside of a posted radiation area, the area must be restricted and access to the area controlled limited to individuals who:
Have received appropriate hazard awareness training;
Have a legitimate reason to be in the area;
Are approved to be in the area by the machine operator.

Machines used in veterinary clinical training, research and service machines

General requirements for any use of radiographic (x-ray) diagnostic imaging equipment:
During radiographic procedures, protocols and auxiliary equipment must be used to minimize personnel exposure to assure that the risk of exposure is commensurate with the needed diagnostic information (ALARA);
The Authorized User is responsible at all times, through the supervision and training of their approved machine operators for the control, security and use of the machine and must assure the following requirements are met during any use of this equipment:
Only approved operators, listed on the authorization and who have documented specific training in the operation of the machine for the designed and RSC-approved uses are to supervise the machine’s operation;
The uses are to be limited to clinical or research radiographic imaging procedures performed on an animal(s) that have been “prescribed” and approved and will be supervised by a degreed veterinarian working under the authority of the University;

NOTE: There is NO approved or allowed use of sources of ionizing radiation on a human under the University’s state-issued machine registrations. No part of a human is to be in the primary beam of a radiation machine for any reason !

Only essential radiation workers assigned and wearing dosimetry are to be allowed close to the location of a radiographic imaging procedure (i.e. – within the room or within a controlled restricted zone) as is required to prevent any exposure to a member of the general public.
In all uses of diagnostic x-ray machines the following conditions are to be met:
Leaded aprons and gloves must be used by occupational workers who must be near the primary beam;
Mechanical machine and cassette holding devices must be used to ensure adequate protection of the radiation worker, as described and intended by the device manufacturer;
Sedation and mechanical restraint will be used for veterinary patient during the imaging procedure as may be required to assure safety and ALARA.
A fluoroscopic imaging systems are only to be operated by trained technicians or professionals (graduate DVM, residents, radiologists, cardiologists, etc.) who are:
Radiation workers listed under the Authorization supervising the equipment;
Have received specialized, advanced training in the use of the equipment; in hazard awareness; and in the radiation protection requirements for the specific equipment operation they are approved to perform under the Authorization.
Mobile and portable clinical x-ray devices
A mobile machine is typically set-up by the manufacturer on casters or a similar conveyance method to allow it to be moved between contiguous rooms (i.e. mobile dental machine; “bedside portable”; mobile C-arm fluoroscopy machine);
A portable machine is designed by the manufacturer so that the machine and image receptor components can be disassembled for transport to a use location where the machine is assembled per manufacturer instructions on to a stable stand prior to its use (i.e. – veterinary portable “mini” x-rays machine).
In all uses the following conditions are to be met:
Collimation is to be used in all exposures to assure the entire cross section of the useful beam produces a useful image and is intercepted by a primary protective barrier (usually an image receptor assembly);
The exposure is automatically, or can be manually, terminated if the barrier is removed or becomes ineffective in shielding the operator from the primary beam.
Protective aprons of at least 0.25 mm lead equivalent are provided and worn by all persons in the room who are participating (near) the primary beam or scatterer;
Only persons required for the completion of the procedure are allowed in the room (restricted area) during the exposure.
Mobile Fluoroscopic equipment is to be operated:
In restricted and controlled access areas such that only appropriate radiation workers can enter the area during the radiation exposure(s);
The equipment is rendered inoperable unless the useful beam is intercepted by the image intensifier;
In the absence of a tabletop, a cone or measuring device is used to ensure an appropriate source-to-skin distance of greater than 12 inches for all exposures.
Densitometry machines
An analytical bone densitometer, also known as a dual energy X-ray absorptiometry (DEXA) scan or QDR, can be used to measure bone mineral density (BMD) in dogs and other small animals for clinical and research purposes;
Conventional building materials in walls, partitions, floors and ceiling provides adequate radiation shielding for these specific types of low output machines;
If there is excessive workload or other circumstance, the RSO or RSC may require the additional use/installation of lead shielding.
Radiotherapeutic equipment
A clinical linear accelerator that produces megavolt electron beam and/or x-ray beams is available for the treatment of veterinary patients under the Authorization of a graduate, board certified DVM;
This equipment may also be used for research purposes ( i.e. – research animal and cell culture irradiations);
No individual is to be in a teletherapy suite while the linear accelerator in producing a radiation beam (e.g. – x-ray or electron).
All manufacturer-installed and/or regulatory-required fail safe devices must be functioning normally, as determined by daily pre-operational quality assurance assessments.

Research particle accelerator
All safety and warning devices, including interlocks, are to be checked for proper operation prior to initiating operation and after any modification to the system;
Documentation is to be prepared by the Authorized User and maintained for all quality assurance and radiation safety assessments procedures (ambient radiation field readings) appropriate to the specific device.
Records of operation and use are to include the date of use; equipment operator name, type of use and any changes or modification made to the equipment or safety equipment or protocols during the machine operation;
All major modifications to the equipment and facility are to be pre-approved by the RSC through the submission, review and approval of an Authorization Amendment application.
Any machine malfunction that results in a non-ALARA exposure or a breach of safety is to be followed by:
An immediate cessation of machine operation;
Timely written notification to the RSO of:
The individuals involved;
Circumstances of operation that resulted in the breach of ALARA or machine malfunction;
Corrective actions to be taken by the AU and machine operator(s) to resolve and prevent similar occurrences.

6.5 Radiation Machine and Machine Authorization Management

Machine Inactivation
An AU may request the RSO place a machine and/or the associated radiation use facility or their Authorization into an inactive status by emailing the specific details of their request to the RSO Radiation Machine program coordinator (RSO e-mail).
The AU must have no future plan, or foresee no need for operation of the machine, for a period of > 12 consecutive months.
The AU must maintain control of the machine and radiation facility, with all restrictions to access in place, until notified in writing by the RSO that the inactivation process has been completed.
Upon receipt of a request to inactivate a machine, the RSO will complete the following steps:
Audit the facility and Authorization to assure all required records are complete and in place at the use location;
Apply a lock-out device to the machine to temporarily eliminate its operational capability (i.e. – typically by a method that results in a temporary power supply disconnect);
Assure the appropriate retention and availability of required records through the regulatory retention period;
Suspend of the machine state registration.

Machine Authorization Inactivation
An AU may request the RSO place their Authorization, and therefore all machines listed on their Authorization, into Inactive status by emailing the specific details of their request to the RSO Radiation Machine program coordinator (RSO e-mail).
The AU must have no future plan, or foresee no need for operation of any machine listed on the Authorization, for a period of > 12 consecutive months.
The AU must maintain control of all machine and radiation facilities, with all restrictions to access in place, until notified in writing by the RSO that the Authorization Inactivation process has been completed.
Upon receipt of a request to inactivate a machine Authorization, the RSO will contact the AU to outline the required steps involved in an Inactivation and a Re-activation of their Authorization.
When in Inactive status there can be no use of the machines listed under the Authorization.
The RSO will continue to audit the radiation use facility on an on-going basis but will suspend requirements for machine inspection(s) until the re-activation process is underway.

Machine Authorization Deactivation (Termination)
An AU should notify the RSO weeks in advance if they plan to deactivate a machine Authorization.
- The AU must provide the RSO of notification of Authorization deactivation (termination) in writing. This notice can be made through an email to the RSO (RSO e-mail) send from the AU’s University e-mail account;
- The RSO Machine program coordinator will contact the AU to facilitate the Authorization deactivation process;
- The AU must maintain control of all machines and radiation facilities listed on their Authorization, with all restrictions to access in place, until notified in writing by the RSO that the de-activation process has been completed.
If the Authorization deactivation is to be concurrent with a departmental re-assignment of supervisory oversight and responsibility for departmental radiation machine(s), a “new” Authorization application will be required.
The department or AU must pre-notify the RSO of any planned or pending transfer of responsibility for a radiation generating machine;
The RSO/RSC will facilitate the transfer process if:
- The proposed new supervisory AU is qualified by training and experience and submits an Authorization application, to be reviewed and approved by the RSC (see RPPM 3.4.6, 4, and 10.D).
- The applicant is qualified by training and experience and agrees to assume the responsibility for oversight of the radiation facilities, machine operations and training and supervision of all radiation workers..
- The Authorization is properly updated and amended prior to any change in supervisory authority; machine(s); facility; or use of the equipment.
If there are no pending transfers of machine oversight for the machine(s) listed on an Authorization that is being de-activated, the RSO will:
Complete the steps listed above for machine inactivation for each machine held under the Authorization;
Suspend dosimetry for all radiation workers listed under the Authorization.
The AU and/or supporting department must make arrangements for the removal and disposition of the equipment, via the methods listed below.

Radiation Machine Removal from an Authorization and University Inventory
An AU may request a machine be removed from their Authorization if the machine is no longer needed, but they wish to maintain their Authorization for other approved machine use(s).
The AU must formally notify the to the RSO Radiation Machine program coordinator of their request and all associated details in writing (RSO e-mail).

The RSO will:
Lock-out the machine on the schedule specified by the AU;
Suspend the machine’s State registration.
The machine will remain disabled until the AU can make arrangements for the permanent removal and disposition of the equipment (see below).
Transfer of a Machine Authorization to a “new” AU
- Relocation of radiation-generating equipment within the University will be facilitated by the RSO/RSC if:
An Authorization amendment application specifying the desired change(s) is submitted;
The planned usage (workload) and anticipated operating parameters of the machine at the new location are included in the Authorization amendment application;
The planned new location is suitable for the use and meets WA DOH shielding and safety requirements;
A shielding assessment of the new facility, if required, is performed by a qualified expert service provider and accepted by the WA DOH;
A qualified expert is contracted to de-install and re-install the machine at the new location and appropriate acceptance testing verifies the equipment meets manufacturer specifications; and a copy of the acceptance testing record is provided to the RSO;
The machine and facility pass an RSO pre-operational machine and facility inspection.

Transfer to a radiation generating machine to a non-University recipient (Disposition)
When a transfer or disposal of a radiation machine is planned, whether a return to the manufacturer; sale or donation to another qualified user; or sale as scrap metal, the supervising AU or department maintaining control of the machine must notify the RSO in writing and must receive written permission for the transfer or disposal.
State regulation requires the University (RSO) track the change of ownership and possession of a radiation-generating machine that could represent a hazard to the public;
A University department, at any campus or research station, must receive prior approval from the RSO in order to remove, deactivate, and/or surplus any item labeled as a source of ionizing radiation (see BPPM 20.76.4)
The RSO must verify and document prior to a transfer that the recipient of equipment that retains the capability to generate ionizing radiation is qualified to safely and compliantly assume possession and ownership of that equipment;
If the planned recipient is not properly qualified or does not intend to install or operate the equipment as a State or NRC-registered radiation device the RSO will disable the machine (i.e. – remove or destroy the x-ray tube) to assure that injury to the general public cannot occur following the transfer.