Boston University/ Boston Medical Center
Analytical X-Ray Safety Manual
BOSTON UNIVERSITY ANALYTICAL X-RAY EQUIPMENT SAFETY PROGRAM
Table of Contents / Page1.0 / Purpose / 5
2.0 / Scope and Applications / 5
3.0 / Organization of X-ray Safety Program
3.1 Permitting and Registration
3.2 Training and Instruction
3.3 Enforcement Actions
3.4 Deficiency Correction / 5
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4.0 / Analytical X-ray Equipment:
4.1 X-ray Permit Holder’s Responsibilities
4.2 X-ray Supervisor’s Responsibilities
4.3 Operators' Responsibilities
4.4 Minors / 9
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10
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5.0 / General Equipment and Safety Requirements
5.1 Safety Devices
5.2 Warning Devices
5.3 Ports
5.4 Labeling
5.5 Shutters
5.6 Warning Lights
5.7 Radiation Source Housing
5.8 Generator Cabinet
5.9 Separate Room
5.10 Permanent Shields
5.11 Set Up Procedures
5.12 Test Safety Devices
5.13 Viewing Devices and Alignment
5.14 X-ray Use Log / 11
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6.0 / Radiation Survey / 14
7.0 / Personal Monitoring and Control of X-ray Exposure
7.1 Proper Use of Dosimetry Devices / 15
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Table of Contents / Page
Appendix A: Definitions / 17
Appendix B: Application for a Permit to Possess and Use Equipment that Emits Ionizing Radiation (XR-1) / 21
Appendix C: X-ray User Certification Form (XR-2) / 26
Appendix D: Template SOP (XR-3) / 28
Appendix E: X-ray Laboratory Inspection Checklist (XR-4) / 38
Appendix F: X-ray Equipment Inventory (XR-5) / 41
1.0 Purpose
Analytical X-ray equipment is used for X-ray diffraction analysis, fluorescence analysis, or direct X-ray transmission analysis of materials. These analytical X-ray systems are comprised of components that utilize X-rays to determine elemental composition, or to examine the microstructure of materials. These analytical X-ray devices are used for non-medical purposes.
The primary objective of this program is to keep occupational exposures to radiation As Low As Reasonably Achievable (ALARA) while utilizing these types of equipment. This safety program establishes Boston University and Boston Medical Center procedures for the safe operation of analytical X-ray equipment and the associated potential radiation hazards.
2.0 Scope and Application
Analytical X-ray equipment has become a major tool in research and quality control programs. Despite the advances in operating techniques and equipment design, the most common hazards are due to operators' errors and equipment malfunctions. The potential exposures to the primary beam are of a major concern when evaluating potential radiation exposures. Exposures to the primary beam in a typical analytical X-ray unit may be as great as 100,000 R/min.
This program applies to all departments, supervisors, employees, students, visiting scientists, and any personnel from other organizations who work with or near analytical X-ray equipment at Boston University. Operational procedures will be established for each X-ray unit to maintain radiation exposures As Low As Reasonably Achievable (ALARA) with due considerations as to the feasibility and nature of the research being conducted.
3.0 Organization of X-ray Safety Program
Radiation Safety Committee:
The Boston University (BU) and Boston Medical Center (BMC) Radiation Safety Committee is responsible for the establishment and continuing review of the Radiation Safety Program at Boston University and Boston Medical Center (BU/BMC). The Committee is also responsible for the BU and BMC compliance with the radiation safety regulations promulgated by the State, Federal, and local agencies for ionizing radiation-producing equipment. Such equipment must be registered with the BU/BMC Division of Medical Physics and Radiation Safety (DMPRS). Boston University has a separate Laser Safety Committee and Program which deals with the use of laser equipment.
Chief Medical Physicist:
The Chief Medical Physicist oversees the implementation of the analytical X-ray equipment program including surveys, procedures and incident review.
Radiation Safety Officer:
The Radiation Safety Officer oversees the radiological safety of the analytical X-ray equipment.
Boston University Division of Medical Physics and Radiation Safety
The Boston University Division of Medical Physics and Radiation Safety (DMPRS) provides services to assist departments, supervisors, students and technicians in maintaining a comprehensive analytical X-ray equipment safety program including:
1. Training and instruction in the safety procedures and practices required for all persons who work with or near analytical X-ray equipment.
2. Managing the RIMS website that allows X-ray Permit Holders to review information specific to their labs such as Authorized User status, training status, and lab profile information at http://www.bu.edu/rims
3. Maintaining a current listing of analytical X-ray equipment and its authorized users.
4. Evaluating each installation as to the control of radiation exposures including recommendations for placement of radiation warning signs and/or warning devices.
5. Performing routine annual radiation safety inspections of analytical X-ray equipment.
6. Review and approval of modifications to X-ray apparatus that affects radiation protection including X-ray tube housing, cameras, shielding, and safety interlocks.
7. Providing personal monitoring badges and area monitors.
8. Investigating any unusual radiation exposures to personnel and taking remedial action, if necessary.
9. Assisting in achieving compliance with all applicable federal, state, and local rules and regulations.
10. Registering X-ray units with the Massachusetts Department of Public Health as per section 105 CMR 120.000.
3.1 Permitting and Registration of users of Analytical X-ray equipment with the Division of Medical Physics and Radiation Safety
All analytical X-ray equipment must be registered with DMPRS using X-ray Equipment Inventory Form XR-5.
The supervisor of the analytical X-ray equipment must apply for a Permit to Possess and Use Equipment that Emits Ionizing Radiation using Form XR-1.
Permits are issued by Radiation Safety Committee upon recommendation by Radiation Generating Devices Subcommittee.
Permits are revived annually by DMPRS.
No person shall begin using analytical X-ray equipment without first completing the required DMPRS training and SOP specific training which is to be documented on the
X-ray User Certification Form, XR-2.
3.2 Training and Instruction
Individuals requiring X-ray Safety training may register for training on-line via RIMS at http://www.bu.edu/rims/
a. Permit Holders, Lab Staff, and Students
All permit holders, laboratory staff, and students working with or frequenting a lab using analytical X-ray equipment must complete the Basic Analytical X-ray Training on RIMS. The permit holder must provide to staff and students any additional training specific to the instrument and its standard operating procedures.
b. Auxiliary Workers
All custodians, trades and non-technical workers who will work in or frequent an X-ray restricted area must attend the Radiation Safety Awareness program presented by DMPRS.
c. Visitors
A visitor is defined as someone who enters the lab on an infrequent basis solely for the purposes of observation. A visitor may not operate the Analytical X-ray Equipment
d. Exceptions
The Radiation Safety Officer (RSO) or Chief Medical Physicist may exercise discretion in modifying the training requirements for each training category as appropriate.
3.3 Enforcement Actions
The Radiation Safety Committee can suspend or revoke an Analytical X-ray Permit which is not in compliance with BU/BMC policies and regulations. When an Analytical X-ray Permit is suspended or revoked, authorized users of that equipment may not utilize the unit and the equipment may be locked out at the discretion of the RSO.
A suspended authorization will not be reinstated until the Committee is assured that reasonable measures have been instituted to prevent recurrence of the deficiencies.
A revoked permit will require new permit application
3.4 Deficiency Correction
Laboratories using analytical X-ray equipment are inspected by DMPRS annually. Additional inspections may be conducted at the discretion of the Radiation Safety Officer or Chief Medical Physicist, for example, as a component of an X-ray incident investigation.
The results of the inspection will be documented with copies sent to the Permit Holder. Inspection findings will be reported to the Radiation Generating Device subcommittee for further recommendation
4.0 Analytical X-ray Equipment
The inventory of the analytical X-ray equipment is available in DMPRS
4.1 Permit Holder's Responsibilities
Each analytical X-ray equipment Permit Holder is responsible for:
1. Providing the Boston University DMPRS with a complete XR-1 form (Application for Permit to Possess and Use Equipment that Emits Ionizing Radiation at BU). See Appendix B. DMPRS will review each proposed installation and corresponding operating procedures. A permit must be obtained from the Radiation Safety Committee before the X-ray equipment is operated.
2. All operations carried out with the equipment.
3. Ensuring that all the personnel under their supervision are registered with and receive initial training from the DMPRS in analytical X-ray equipment safety.
4. Compliance with the specific recommendations made by the DMPRS, and also the general equipment and safety requirements listed in Section 7.0.
5. Ensuring that only authorized users will enter the areas that are restricted due to the use of the analytical X-ray units.
6. Providing specific hands-on training to the authorized user(s) for each analytical X-ray unit, in accordance with the approved Standard Operating Procedures (SOP). A template SOP may be found in Appendix D, Form XR-3. Completed SOPs for each piece of X-ray equipment will be maintained in the X-ray Manual and updated annually. An up-to-date list of Authorized Users shall be posted on the lab’s permit.
7. Ensuring that the project has a properly operating survey instrument that has been calibrated within the last twelve months.
8. Informing DMPRS of acquisitions, transfers, servicing or decommissioning of X-ray equipment. The X-ray inventory shall be amended as needed to reflect such changes. (Appendix F, Form XR-5).
9. Notifying the Radiation Safety Officer (RSO) and Chief Medical Physicist of the Boston University Division of Medical Physics and Radiation Safety when:
a) it is necessary to alter safety devices, such as bypassing interlocks. The exception would be generic bypassing for test purposes that has been authorized by DMPRS.
b) it is known or suspected that a radiation exposure of personnel may have occurred.
c) an existing unit is moved or beam path is altered.
d) there are changes in operating parameters such as kV and mA beyond that which were approved by DMPRS.
e) there are changes in the approved shielding.
f) there is any major service performed on the X-ray unit by lab personnel.
g) an outside service technician is contracted. Such technician must be registered with the MDPH and approved by the RSO or Chief Medical Physicist.
h) planning to procure new analytical X-ray equipment or to dispose, sell or gift unwanted equipment. Procurement or removal of such equipment requires the advance authorization of the BU RSO.
10. Emergency Procedures
Written emergency procedures shall be established for each X-ray analytical unit by the Permit Holder and shall be posted in a conspicuous location near each X-ray unit. These should include the telephone number(s) of the Permit Holder, the BU Division of Medical Physics and Radiation Safety, the BU Campus Police Department, and instructions to follow in the event of a known or suspected accident involving radiation exposure
4.2 X-ray Supervisor’s Responsibility
1. Assuming the responsibilities of the X-ray Permit Holder in the absence of that individual.
4.3 Operators’ Responsibility
Each authorized user of the analytical X-ray equipment is responsible for:
1. Completing the analytical X-ray safety training provided by the BU DMPRS prior to operating the analytical X-ray equipment.
2. Receiving specific hands-on training with each analytical X-ray instrument provided by the X-ray supervisor in accordance with the written SOP.
3. Wearing the assigned personal monitoring dosimeter (s) (see Section 7.0)
4. Documentation of items 1, 2 and 3 on the X-ray User Authorization Form, XR-2 (see Appendix C) that is maintained in the X-ray Safety Manual in the laboratory.
4.4 Minors
Minors are not allowed to operate analytical X-ray equipment. The Permit Holder shall be responsible for ensuring that the presence of any minor in the laboratory is in full compliance with the Boston University Personnel Policy Manual (see http://www.bu.edu/hr/files/documents/employee-handbook.pdf, page 8).
5.0 General Equipment and Safety Requirements
As defined in 105 CMR 120.603.
5.1 SAFETY DEVICE
A device which prevents the entry of any portion of an individual's body into the primary X-ray beam path or which causes the beam to be shut off upon entry into its path shall be provided on all open beam configurations. Exception to this requirement may be granted through the Department of Public Health with the prior approval of the BU RSO and Chief Medical Physicist.
5.2 WARNING DEVICES
Open beam configurations shall be provided with a readily discernible indication of:
a.) X-ray tube "on-off" status located near the radiation source housing if the primary beam is controlled in this manner; and/or
b.) Shutter "open-closed" status located near each port on the radiation source housing if the primary beam is controlled in this manner.
Warning devices shall be labeled so that their purpose is easily identifiable. On equipment installed after February 9, 1996, warning devices shall have fail-safe characteristics.
5.3 PORTS
Unused ports on radiation source housings shall be secured in the closed position in a manner that will prevent casual opening.
5.4 LABELING
All analytical X-ray equipment shall be labeled with readily discernible sign(s) bearing the radiation symbol and the words:
a.) "CAUTION-HIGH INTENSITY X-RAY BEAM" on X-ray source housing; and
b.) CAUTION RADIATION-THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED" near any switch that energizes an X-ray tube if the radiation source is an X-ray tube; or
c.) CAUTION-RADIOACTIVE MATERIAL" on the source housing if the radiation source is a radionuclide.
5.5 SHUTTERS
On open beam configurations installed after February 9, 1996, each port on the radiation source housing shall be equipped with a shutter that cannot be opened unless a collimator or a coupling has been connected to the port.
5.6 WARNING LIGHTS
An easily visible warning light labeled with the words "X-RAY ON" shall be located:
a.) near any switch that energizes an X-ray tube and shall be illuminated only when the tube is energized; or
b.) In the case of a radioactive source, near any switch that opens a housing shutter and shall be illuminated only when the shutter is open.
On equipment installed after February 9, 1996, warning lights shall have fail-safe characteristics.