Post on 18-Mar-2020
Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila ● Trunk Line 651-7800 Direct Line: 711-9501
Fax: 743-1829; 743-1786 ● URL: http://www.doh.gov.ph; e-mail: osec@doh.gov.ph
Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
1
2
ADMINISTRATIVE ORDER 3
No. 2017 - ______ 4
5
SUBJECT: “Radiation Safety Standards and Requirements on the 6 Operation of Diagnostic and Interventional X-ray 7 Facilities” 8
9
I RATIONALE/BACKGROUND 10
11
Medical uses of ionizing radiation are amongst the longest established 12
applications of ionizing radiation. Current estimates put the worldwide annual number 13
of diagnostic and interventional radiological procedures at over 3000 million. In the 14
Philippines, there are about 3,000 x-ray facilities doing diagnostic and interventional 15
procedures. These medical uses bring considerable public health benefits. However, 16
ionizing radiation using x-rays can cause harm and a systematic approach should be 17
applied to ensure that there is a balance between being able to utilize the benefits from 18
medical uses of x-rays and minimizing the risk of radiation effects to patients, 19
workers and members of the public. 20
In 1996, the International Atomic Energy Agency (IAEA), published the Basic 21
Safety Standards entitled “Basic Safety Standards for Protection against Ionizing 22
Radiation and for the Safety of Radiation Sources”. This standard contains 23
recommendations on the safe use of radiation sources to serve as a guide in the 24
harmonization of standards for radiation regulation bodies of its member states. To 25
address the need for harmonization of standards with the IAEA, in 2004, the 26
Department of Health adopted the international standard with the issuance of the 27
Administrative Order (AO) No. 149 entitled “Basic Standards on Radiation Protection 28
and Safety Governing the Authorization for the Introduction and Conduct of Practices 29
Involving X-ray Sources in the Philippines. The Department of Health (DOH) 30
Circular No. 323 s. 2004 (Manual on Basic Radiation Protection and Safety of X-ray 31
Sources) was also issued as an integral part of AO.149. These AO and Department 32
Circular contained general guidelines for the promulgation of radiation protection and 33
safety requirements in the establishment and operation of x-ray devices and facilities. 34
General Safety Requirements (GSR) Part 3 was published by the IAEA in 35 2014 that supersedes IBSS No. 115 issued in 1996. Due to the replacement of the 36 IBSS No. 115 by the GSR Part 3, AOs 149, 164, DOH Circular 323 and all other 37
existing national standards and regulatory requirements has been revised and 38 superseded by AO __ entitled “Radiation Protection and Safety of X-ray Sources in 39 Planned Exposure Situations : Adoption of International Basic Safety Standards, 40
General Safety Requirements (GSR) Part 3”. 41 42 This AO provides guidance on fulfilling the requirements of GSR Part 3 with 43
respect to medical uses of ionizing radiation. It is aimed primarily at end-users in 44
FIRST DRAFT
For Consultative Meeting as of 17 May 2018
Page 2 of 17
medical radiation facilities where radiological procedures are performed, including 1
management, radiological medical practitioners, medical radiation technologists, 2 medical physicists, radiation protection officers and other health professionals. It also 3 provides recommendations and guidance to health professionals who refer patients for 4 radiological procedures; to manufacturers and suppliers of medical radiological 5
equipment. This AO will supersede AO. No. 35 s. 1994 entitled “ Requirements for 6 the Control of Radiation Hazards from Clinical Diagnostic X-ray Facilities. 7
8 This AO does not include guidance on human imaging using ionizing 9
radiation for purposes other than medical diagnosis, medical treatment or biomedical 10
research. Such human imaging using ionizing radiation for other purposes includes 11 exposing people to radiation for employment related, legal or health insurance 12 purposes without reference to clinical indications, and human imaging using ionizing 13
radiation for the detection of concealed objects for anti-smuggling purposes or for the 14 detection of concealed objects that could be used for criminal acts that pose a national 15 security threat. 16
17
Pursuant to Republic Act No. 9711 and its Implementing Rules and 18
Regulation consistent with the harmonization and adoption of the applicable IAEA 19
standards, and in order to strengthen the standard of safety, the DOH through the 20
FDA, promulgates the rules and regulations for the specific practice on the use of x-21
ray devices for diagnostic radiology and interventional procedures. 22
23
II OBJECTIVE 24
25
These Rules and Regulations are promulgated in order to strengthen the 26
regulatory policy that will protect the patient, the workers as well as the members of 27
the public in the hazards on the use of x-ray devices in diagnostic radiology and 28
interventional procedures; ensure compliance among responsible parties, 29
stakeholders and individuals involved in those practices; to consider advances in 30
technology with regards to diagnostic and interventional procedures using x-rays, and 31
to provide guidance in meeting the regulatory requirements. 32
33
Specifically, this Order aims to: 34
1. Provide the administrative, human resource, x-ray machines, physical 35
plant, and radiation protection requirements; 36
2. Provide the classification of medical diagnostic x-ray facilities; and, 37
3. Provide the guidelines in fulfilling a Quality Assurance Program. 38
39
III SCOPE 40
1. These rules and regulations shall apply to any person, firm, 41
corporation, establishment or entity, whether government or private, 42
operating and maintaining a diagnostic and interventional x-ray 43
facilities and to the individuals involved in those practices. 44
45
2. Exclusions: These requirements shall not apply to the following: 46
2.1. Therapeutic x-ray facilities utilizing medical linear accelerators, 47
educational, industrial, anti-crime, research, veterinary, and dental x-48
Page 3 of 17
ray facilities which are covered by other regulations issued by the 1
FDA. 2
2.2. X-ray facilities used exclusively for forensic examinations; and 3
2.3. Diagnostic imaging devices using radioactive sources and 4
2.4 Human imaging using x-rays for purposes other than medical 5
diagnosis, medical treatment or biomedical research 6
7
IV DEFINITION OF TERMS 8
9
Acceptance Testing – the initial inspection performed on a piece of medical 10
equipment prior to it being put in place. When the device first arrives in the 11
healthcare facility, it is checked to ensure it matches the purchase order, it is 12
functioning as specified, the training for users has been arranged and it is 13
installed correctly (WHO definition, 2011). 14
Authorization – is a permission embodied in a document, granted by the 15
DOH through the Food and Drug Administration to an authorized person or 16
company who has satisfactorily complied the requirements in the submission 17
of an application to operate, maintain or establish a facility using diagnostic x-18
ray devices. The authorization can be in the form of a license to operate (LTO) 19
or a Certificate of Compliance (COC). 20
21
Authorized Officer - is an owner or legal person who is either natural (e.g., 22
single proprietorship) or juridical (e.g., partnership or a corporation) person. 23
24
Chest for Heart and Lungs – is an x-ray service category capable of 25
performing radiographic examination which produces images of the heart, 26
lungs, airways, blood vessels and the bones of the spine and chest. 27 28
29
Clinically Qualified Medical Physicist – is a health professional, with 30
specialist education and training in the concepts and techniques of applying 31
physics in medicine and competent to practice independently in one or more of 32
the subfields (specialties) of medical physics. 33
34
Commissioning – procedures carried out by the facility representative usually 35
a medical physicist specializing in radiology physics, to ensure that the 36
equipment is ready for clinical use and to establish baseline values against 37
which the results of subsequent routine performance be compared. 38
39
Controlled Area – a defined area in which specific protection measures and 40
safety provisions are or could be required for controlling exposures or 41
preventing x-ray exposures in normal working conditions. An area where a 42
person is likely to receive an effective dose greater than 6 mSv (or an 43
equivalent dose of greater than three-tenths of any dose limit). 44 45
Corrective Maintenance – a process used to restore the physical integrity, 46
safety and/or performance of an x-ray machine after a failure. 47
Page 4 of 17
Diagnostic Radiology – is a branch of medical practice concerned with the 1
use of imaging techniques in the study, diagnosis and x-ray guided treatment 2
of disease. This includes the use of x-rays in general radiography and 3
fluoroscopy, interventional radiology, lithotripsy, computed tomography, 4
mammography, bone densitometry, and tumor localization and simulation. 5
6
Diagnostic and Interventional Radiology Medical Physicist (DIRMP)- is a 7
Clinically Qualified Medical Physicist, who, by virtue of certification by 8
appropriate boards or societies, professional licenses or academic qualification 9
and experience duly recognized as having expertise in diagnostic and 10
interventional radiology medical physics and is charged with specific duties and 11
responsibilities indicated herein and in Appendix B of this AO. 12
13
Digital Imaging and Communications in Medicine (DICOM) – is a 14
standard for medical device intercommunication and for the storage and 15
transmission of medical images. 16
17
Dose Limit – the value of the effective dose or the equivalent dose to 18
individuals in planned exposure situations that is not to be exceeded. 19
20
Facilities and Activities – the term facilities and activities is a general term 21
encompassing any human activity that may cause people to be exposed to 22
radiation risk arising from naturally occurring or artificial sources. In this AO 23
the term facilities refers to the x-ray facility conducting diagnostic and 24
interventional procedures while activities refers to the use of x-ray devices. 25
26
Fluoroscopy – is a technique for obtaining continuously or periodically a 27
sequence of x-ray patterns and presenting them simultaneously and 28
continuously as visible images. 29
30
International Electrotechnical Commission (IEC) – an independent 31
organization that prepares and publishes International Standards for all 32
electrical, electronic and related technologies, collectively known as 33
“electrotechnology”. 34
International Organization for Standardization (ISO) – an independent, 35
non-governmental international organization of national standards bodies from 36
different countries. The members develop voluntary, consensus-based, market 37
relevant International Standards that support innovation and provide solutions 38
to global challenges. 39
Interventional Radiology – comprises image-guided diagnostic and 40
therapeutic procedures where access is percutaneous and is usually performed 41
under local anaesthesia and/or sedation. 42
Licensee – is the holder of a current authorization granted to establishments 43
by the FDA for a practice of diagnostic radiology and who has recognized 44
rights and duties, particularly in relation to protection and safety. 45
Page 5 of 17
Lithotripsy – is an x-ray image guided medical procedure that uses shock 1
waves to break up the stones in the kidney, ureter, or bladder. 2
3
Medical Radiation Practitioner – is a physician with qualifications as 4
specified in Appendix A of this AO who is responsible for the overall conduct 5
of the procedures involving the exposure of the patient to ionizing radiation 6
from x-rays. 7
Mobile X-ray Machine – is an x-ray machine that is intended to be moved 8
from one location to another between periods of use while supported by its 9
own wheels or equivalent means. 10
11
Picture Archiving and Communication System (PACS) – is a medical 12
imaging technology which provides economical storage and access to images. 13
14
Radiology Information System (RIS) – computerized database used by 15
radiology departments to store, manipulate and distribute radiological images. 16
17
Performance Testing – testing of radiologic equipment for compliance with 18
the national radiation protection regulations and with other standards that have 19
been adopted by the FDA. Performance Testing can either be constancy 20
(routine) or quality control testing. 21 22
Philippine National Standards (PNS) – are documents established by 23
consensus through a technical committee and approved by the Bureau of 24
Product Standards, which provides, for common and repeated use, rules, 25
guidelines or characteristics for activities or their results, aimed at the 26
achievement of the optimum degree of order in a given context 27
28
Pre-Licensing Inspection also termed as Radiation Protection Survey and 29
Evaluation (RPSE) – is a comprehensive on-site inspection and evaluation of 30
the x-ray facility including, but not limited to, the assessment of machine 31
performance, x-ray tube leakage radiation, adequacy of shielding barriers, and 32
accessories, etc. 33
34
Post-Licensing Inspection also termed as Facility Compliance Monitoring 35
(FCM) – is an activity or procedure conducted by the regulatory body to 36
determine whether x-ray sources are being used in accordance with the 37
requirements of the relevant regulations and any conditions of the autho rization. 38
39
Preventive Maintenance – is a planned procedure to ensure that the x-ray 40
equipment is kept in good condition, in order to provide a long operating life. 41
42
Quality Assurance Program – a management tool which, through the 43
development of policies and the establishment of review procedures, aim to 44
ensure that every examination or treatment is necessary, appropriate and 45
performed according to previously accepted clinical protocols by adequately 46
trained personnel using properly selected and functioning equipment to the 47
satisfaction of the patient and referring physicians safely and at minimum cost. 48
Page 6 of 17
1
Quality Control Program – a component of a quality assurance program that 2
deals with the monitoring of the technical parameters that greatly affects both 3
the image quality and performance of the x-ray equipment. 4 5
Quality Control Technologist – a radiologic technologist designated by the 6
licensee who is charged to perform or supervise all individual tasks within the 7
quality assurance program not assigned to the medical radiation practitioner or 8
to the medical physicist. 9
10
Radiation Protection Officer – a person technically competent in radiation 11
protection matters relevant for diagnostic radiology and is designated by the 12
licensee to oversee the application of relevant radiation protection and safety 13
requirements established by the FDA or by international standards. 14 15
Radiation Protection Program – is a systematic arrangement which is aimed 16
at providing adequate consideration of radiation protection and safety 17
measures in an x-ray facility. 18
19
Safety Assessment Plan – is the assessment of all aspects of a practice that are 20
relevant to protection and safety. For an authorized facility, this includes 21
siting, design and operation of the facility. Safety assessment plan is the 22
systematic process that is carried out throughout the lifetime of the facility or 23
activity to ensure that all the relevant safety requirements are met by the 24
proposed (or actual) design. Safety assessment plan includes, but is not limited 25
to, the formal safety analysis. 26
27
Supervised Area – is any area not already designated as a controlled area but 28
where occupational exposure conditions need to be kept under review even 29
though specific protection measures are not normally needed. 30
31
Supplier – is any authorized officer to whom a licensee delegates duties 32
totally or partially in relation to the design, manufacture, or construction of an 33
x-ray source (an importer of an x-ray device is considered as a supplier of the 34
x-ray source) 35
36
Teleradiology – is a branch of telemedicine referring to the use of computers 37
and telecommunication networks to transmit diagnostic images acquired at 38
one location to another for primary review and interpretation as well as 39
specialist consultation. 40
41
Type Tests – are certain tests performed on a type or brand of equipment and 42
do not need to be repeated for all pieces of equipment. 43
44
X-ray Device – means an electrical or electronic apparatus emitting ionizing 45
electromagnetic radiation at the diagnostic range of energies. In this AO, the 46
term x-ray machine, x-ray device, and x-ray equipment are used 47
interchangeably. 48 49
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X-ray Facility – pertains to the structures or installations within the 1
establishment that houses the x-ray machine used in diagnostic radiology. 2
3
V IMPLEMENTING MECHANISMS 4
5
A. GENERAL GUIDELINES 6
7
1. All x-ray facilities shall secure an authorization from the FDA. No x-ray 8
facility shall be allowed to operate without a valid authorization issued by the 9
FDA. 10
2. Any authorized officer or organization applying for authorization: 11
2.1. Shall submit to the FDA the relevant information necessary to 12
support the application for an authorization. 13
2.2. Shall refrain from carrying out any actions/activities pertaining to 14
the use of the x-ray equipment until the authorization is issued. 15
2.3. Shall assess the nature, likelihood, and magnitude of the expected 16
exposures due to the x-ray machines and shall take all necessary 17
measures for protection and safety. 18
2.4. Shall have a safety assessment plan made and submitted to the 19
FDA as part of the application. 20
3. All x-ray facilities shall comply with the existing regulations issued by the 21
FDA. The x-ray facility shall follow the procedural guidelines set by the 22
FDA in securing the relevant authorization. 23
4. All radiologic procedures shall be done with the most appropriate device that 24
will result in the optimum diagnostic image. 25
5. The licensee shall hire an adequate number of appropriately trained and 26
qualified personnel for the operation of its x-ray facility. 27
6. Every x-ray facility shall have an x-ray device that is tested to perform safely. 28
A preventive maintenance program shall be provided to ensure that the x-ray 29
equipment is functioning properly. 30
7. All x-ray facilities shall be properly shielded, well ventilated, well lit, clean, 31
safe, and shall have sufficient space to accommodate its activities. 32
8. All x-ray facilities shall have adequate radiation protection accessories to be 33
used in the protection of the patient, the public, and workers from possible 34
unnecessary radiation exposure. 35
9. The licensee shall ensure that an individual radiation monitoring device is 36
provided to each worker. 37
10. The licensee shall ensure that radiation doses to workers and members of the 38
public do not exceed the dose limits specified by the FDA. 39
11. Each x-ray facility shall establish and implement a quality assurance and 40
radiation protection program. 41
12. The Licensee shall permit access of the FDA to carry out inspections of their 42
facilities and activities and of their protection and safety records, and shall 43
cooperate in the conduct of inspection. 44
45
46
Page 8 of 17
B. SPECIFIC GUIDELINES 1
2
1. Administrative Requirements 3 4
1.1.1 The owner/licensee shall submit an authorization application and 5
safety assessment plan of his/her facility and activity, in a 6
prescribed form which shall be reviewed and assessed by the 7
FDA prior to the granting of the authorization. 8
1.1.2 The owner/licensee shall ensure the establishment, 9
implementation, and maintenance of a radiation protection 10
program as shown in Appendix C. 11
1.1.3 The owner/licensee shall ensure that the implementation of a 12
quality assurance program commensurate to the radiological 13
services the facility offers as shown in Appendix D. 14
1.1.4 A Quality Assurance committee shall be established to provide 15
periodic review and evaluation of the facility’s QA program. The 16
results of the review should be recorded, documented and assessed 17
by the QA committee. Results that do not meet tolerance levels 18
should lead to appropriate and timely remedial actions and all 19
such actions should be recorded/documented. 20
1.1.5 The owner/licensee shall ensure that a continuing professional 21
development program with the aim of improving such skills, 22
maintaining familiarity with current practices and fostering a 23
safety culture throughout the facility shall be provided. 24
1.1.6 The owner/licensee shall provide radiation dose monitors to all 25
radiation workers in the facility. He/she shall ensure that records 26
of the radiation doses of workers are kept and reviewed by the 27
RPO. 28
1.1.7 The owner/licensee shall ensure that the requirements for the safety 29
of x-ray machines used in medical exposure shall be so designed 30
as specified in Appendix E. 31
32
2. Classification of medical diagnostic x-ray facility : 33
Medical diagnostic x-ray facilities shall be classified according to the 34
x-ray service categories; appropriate x-ray machine requirements 35
and specific radiographic examinations performed: 36
37
X-ray Service Category X-ray Machine Requirements Radiographic
Examinations performed
Chest for Heart and
Lungs
General Radiography Machine with
tube currents of at least 100 mA except
for high frequency inverter type x-ray
machines and emerging technologies
conforming with internationally
accepted standards
Chest, heart and lungs
examinations procedures
only
Level One General Radiography Machine with Chest for heart and lungs,
Page 9 of 17
tube currents of at least 100 mA except
for high frequency inverter type x-ray
machines and emerging technologies
conforming with internationally
accepted standards
skeletal radiography and
abdomen
Level Two General Radiography Machine with
tube currents of at least 200 mA and/or
Radiography/Fluoroscopy System
and/or Cardiac Catheterization
Helical Computed Tomography
Machine
All of Level one plus
radiographic examinations
with contrast procedures
except interventional
radiology
Level Three General Radiography/Fluoroscopy
System and/or
at least 16 slice Computed Tomography
Machine
All of Level two plus
interventional radiology
except cardiac
catheterization procedures
Specialized
Computed Tomography
Mammography
Cardiac Catheterization
Lithotripsy
Bone Densitometry
Tumour Localization and Simulation
1
2
3. Human Resources: 3
4
3.1 Staffing: 5
6
3.1.1 The licensee shall appoint professionals with qualifications/and or 7
accreditation for the task assigned to them sufficient to ensure that all 8
activities relevant to radiation protection and safety are carried out in 9
accordance with these regulations. 10
11
3.1.2 The number of personnel should be reviewed as to adequacy as the 12
workload increases or as new techniques and/or new or additional equipment 13
are acquired by the facility 14
15
3.1.3 Patient demographic and annual workload data trends should be 16
monitored and documented for facility planning and staffing levels 17
requirement. 18
19
20
21
22
23
Page 10 of 17
1
3.2 Education and Training 2
3
3.2.1. The licensee shall ensure that only personnel who are qualified in terms 4
of education, training and experience shall work in the medical 5
diagnostic/interventional x-ray facility. 6
. 7
3.2.2 All medical practitioners and radiation workers whose work involves 8
his/her presence in the delivery of radiological services shall 9
have attended a training on radiation protection and safety in diagnostic and/or 10
interventional radiology given by the radiation protection officer of the 11
facility, by a CQMP-DIRMP, or any other training provider 12
recognized/organized by the FDA. 13
14
3.2.3 The licensee shall ensure that all personnel are aware of 15
the conditions and limitations of the license: 16
17
a. institutional radiation protection policies and procedures (including 18
practice drills for emergency responses) 19
b. review and analysis of lessons learned from incidents and accidents 20
that have occurred in the facility or elsewhere 21
c. the local quality assurance program and quality control procedures 22
d. use and operation of the equipment and other support devices 23
e. instruction procedures to patients, caregivers and comforters 24
25
3.2.4 The personnel shall be given instructions whenever significant changes 26
occur in the duties and responsibilities, regulations, training including the 27
conditions and limitations of the license or radiation safety procedures. 28
29
3.2.5 The licensee should establish a policy that encourages and provides 30
continuing education and professional development of personnel. The 31
owner/licensee shall ensure that a continuing professional development 32
program with the aim of improving such skills, maintaining familiarity with 33
current practices and fostering a safety culture throughout the facility shall be 34
provided. 35
36
3.2.6 The licensee shall ensure that all non-diagnostic and interventional 37
radiology staff who need to enter the controlled areas of the medical 38
diagnostic/interventional radiology department, be provided with specific 39
instructions on radiation protection. 40
41
3.3 Manpower Requirements: 42
43
All facilities shall employ the following personnel: 44
45
46
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3.3.1 Medical Radiation Practitioner 1
2
3.3.1.1 The licensee shall designate a medical radiation practitioner 3
with qualifications as stated in Appendix A. 4
3.3.1.2 Where applicable, the medical radiation practitioner shall have 5
undergone appropriate training in radiation protection as stated in 6
Appendix A conducted by an organization recognized/organized by 7
the FDA. 8
3.3.1.3 A chief medical radiation practitioner shall be 9
appointed as head of the facility. 10
3.3.1.4 The number of medical radiation practitioner should be 11
reviewed as to adequacy and shall be hired as the workload 12
increases. 13
14
3.3.2 Radiation Protection Officer (RPO) 15
16
3.3.2.1 The licensee shall designate a qualified RPO who is responsible 17
for the practice of radiation protection and safety of the facility and 18
compliance with relevant regulatory requirements. 19
3.3.2.2 The RPO shall ensure that radiation safety activities are 20
performed according to approved safety policies and procedures. 21
He/she shall have the authority to stop any activity that may endanger 22
health and safety. 23
3.3.2.3 The RPO shall either be a diagnostic radiology medical 24
physicist or a radiologic technologist. 25
3.3.2.4 For radiologic technologist to be RPO, he/she shall have 26
completed an appropriate training in radiation protection conducted by 27
an organization recognized by the FDA. 28
3.3.2.5. The RPO shall perform his/her duties and responsibilities as 29
specified in Appendix I. and Section 2 of Appendix B of this AO. 30
31
3.3.3 Clinically Qualified Medical Physicist (CQMP) in Diagnostic and 32
Interventional Radiology 33
3.3.3.1 For Level three, and level three x-ray facilities with equipment 34
categorized in specialized x-ray facilities, the services of a CQMP shall 35
be made available. 36
3.3.3.2 For other x-ray facilities classified in Section V.B.2, the 37
services of a CQMP should be made available. 38
3.3.3.3 The CQMP shall perform his/her duties and responsibilities as 39
specified in Appendix B. 40
41
3.3.4 Radiologic/X-ray Technologist 42
3.3.4.1 At least one (1) full time radiologic/x-ray technologist per 8-43
hour shift shall be hired per machine. 44
3.3.4.2 A chief radiologic technologist shall be appointed in a facility. 45
Page 12 of 17
3.3.4.3 Only qualified female radiologic/x-ray technologist trained to 1
perform mammography procedures shall be allowed. 2
3.3.4.4 For specialized x-ray facilities, the radiologic technologist 3
should have undergone training in the operation of the appropriate x-4
ray machine. 5
6
3.3.5 Quality Control (QC) Technologist 7
8
3.3.5.1 For Level three x-ray facilities, the licensee shall 9
designate a quality control technologist as specified in 10
Appendix J of this AO. 11
3.3.5.2 The QC technologist shall be a radiologic technologist 12
who is specially trained in the conduct of quality control of x- 13
ray equipment commensurate to his/her facility 14
or has attended a quality assurance/quality control 15
course conducted by the FDA or an organization 16
recognized/organized by FDA. 17
18
4. X-ray Machine Requirements 19
20
4.1 The owner/licensee in specific cooperation with suppliers, shall ensure 21
that, with regard to the x-ray machine: 22
23
4.2.1 Whether imported into or manufactured in the Philippines 24
where it is used, the equipment conforms to applicable 25
standards of the IEC and ISO or to equivalent national 26
standards. Evidence of such compliance shall be provided 27
such as type tests, and acceptance tests in the absence of 28
type tests. 29
4.2.2 Performance specifications and operating and maintenance 30
instructions, including protection and safety instructions, be 31
provided in a major world language understandable to the 32
users and in compliance with the relevant IEC or ISO 33
standards with regard to “accompanying documents”. 34
4.2.3 Where practicable, the operating terminology (or its 35
abbreviations) and operating values be displayed on 36
operating consoles in a major language acceptable to the 37
user. 38
4.2.4 Adequate maintenance (preventive and corrective) shall be 39
performed as necessary to ensure that the equipment retain 40
their designed specification for image quality, radiation 41
protection and safety for their useful lives. 42
43
4.2 Each type of x-ray machine shall conform to the minimum 44
performance criteria of an x-ray machine as specified in Table 1 45
of Appendix F and shall comply with the specific x-ray machine 46
Page 13 of 17
requirements and accessories shown in Appendix E. 1
2
4.3 All newly installed, transferred, and modified x-ray machines shall 3
undergo acceptance and commissioning tests conducted by a supplier 4
and a CQMP –Diagnostic and Interventional Radiology or by an 5
establishment providing QA testing services recognized by the 6
Philippine Accreditation Bureau of the Department of Trade and 7
Industry and the FDA. After acceptance testing and commissioning, 8
performance tests shall be done within a specified number of years as 9
indicated in Table 2 of Appendix F. 10
11
4.4 For the supplier, evidence of competence for the acceptance testing, 12
maintenance and servicing of medical equipment shall consist of the 13
following: 14
4.4.1. Certification, ideally from the manufacturer of having 15
completed a training program on the type of x-ray machine. 16
4.4.2. A course on radiation protection on which the contents, the 17
methodology and the teaching institution or training 18
provider is recognized/organized by the FDA. 19
20
5. Physical Plant Requirements 21
22
5.1 X-ray Examination Room 23
5.1.1 The x-ray room size shall satisfy the following 24
specifications: 25
5.1.2.1. X-ray room for x-ray machines not equipped with 26
radiographic table shall have a minimum width 27
of 2.5 meters and minimum length of 3.0 meters 28
5.1.2.2 X-ray room for x-ray machine equipped with 29
radiographic table shall have a minimum width 30
of 3.5 meters and minimum length of 4.0 meters. 31
5.1.2.3. X-ray room for x-ray machine equipped with 32
radiographic/ fluoroscopic machine shall have a 33
minimum width of 4.5 meters and minimum 34
length of 5.0 meters. 35
5.1.2 For a transportable x-ray facility, the x-ray examination 36
room shall be at least 1.0 m x 2.0 m. Due to the limited x-37
ray room size, only upright chest x-ray examinations shall 38
be allowed. 39
40
5.2 X-ray Room Design 41
5.2.1. All walls in the x-ray examination room shall be made of 42
any of the following materials to a height of at least 2 43
meters from the floor level/ground outside the x-ray room: 44
5.2.1.1. at least 15 cm poured concrete; 45
Page 14 of 17
5.2.1.2.at least 20 cm thickness of properly filled concrete 1
hollow blocks and cement plaster. 2
5.2.1.3. at least 1.5 mm thick lead sheet. Care should be 3
taken to avoid punctures in the lead sheet which 4
may occur during installation. The lead sheet 5
should be glued onto and sandwiched between 6
wooden panels. 7
5.2.1.4. Other shielding material may be used but 8
shall have a thickness equivalent to at least 1.5 9
mm of lead. 10
5.2.2. Radiation level measurements at the other side of the walls 11
and door/s shall not exceed 25 μSv/hr (2.5 mR/hr). 12
5.2.3. The base of the x-ray room window/s shall be located at a 13
height of at least 2 meters from the floor of the adjacent area 14
or room. 15
5.2.4. Means for viewing and two way communication between 16
the patient and the x-ray/radiologic technologist during x-ray 17
examination shall be provided. 18
5.2.5. A protective barrier shall be placed at the control console to 19
shield staff, who should not wear protective clothing while 20
at the console. The protective barrier shall be constructed or 21
provided inside the x-ray examination room. The barrier 22
with a dimension of 1m in width and 2m in height should be 23
made of any of the materials enumerated in Section 5.2.1. 24
5.2.6. A red warning light bulb shall be installed outside the x ray 25
examination room above the x-ray room door. It shall be 26
illuminated when the x-ray machine is switched on. 27
5.2.7. A patient’s dressing area shall be provided inside the x-ray 28
examination room. 29
5.2.8. A toilet shall be provided inside the x-ray examination room 30
where procedures with contrast media are performed. 31
32
5.3 Darkroom 33
5.3.1. Where applicable, there shall be a separate darkroom 34
constructed adjacent to the x-ray examination room. 35
5.3.2. The size of the darkroom shall be at least 1m by 1.5m 36
5.3.3. The darkroom shall be light tight, clean and large enough to 37
accommodate the darkroom equipment and accessories. 38
5.3.4. The darkroom shall be well ventilated. It shall be provided 39
with an air inlet and an air outlet with an exhaust fan. 40
However, these openings shall be designed such that no 41
light can enter the room while darkroom work is done. 42
5.3.5. For manual film processing, the processing tank shall 43
consist of a master tank and two (2) insert tanks inside a 44
master tank. The insert tanks shall be made of stainless 45
Page 15 of 17
steel or fiber glass. Separate paddles for mixing the 1
developer and fixer solutions shall be provided. 2
5.3.6. There shall be an adequate supply of water in the master 3
tank. 4
5.3.7. For manual processing, the time-temperature method of 5
processing shall be observed. A countdown timer and an 6
alcohol/digital thermometer shall be provided. 7
8
5.4 Image Interpretation 9
10
5.4.1 A separate film interpretation room/area shall be provided. 11
A negatoscope with luminance of at least 1500 nit for 12
general radiography and 3000 nit for mammography shall 13
be provided. The room illuminance shall be 50 lux or less 14
for mammography. 15
5.4.2 In mammography, the negatoscope shall be provided with a 16
mask to limit the light/luminance to the area of the film. 17
18
5.4.3 Digital display devices used for interpretation of digital 19
images shall have a resolution of at least 2 megapixels 20
except for mammography which shall have at least 5 21
megapixel of resolution. 22
23
5.5 Use of Teleradiology 24
25
5.5.1 Diagnostic x-ray facilities utilizing the practice of 26
teleradiology, the communication protocols, file formats, 27
and image data compression shall conform to Digital 28
Imaging and Communication in Medicine (DICOM) 29
standards. 30
5.5.2 There shall be no reduction of clinically diagnostic image 31
quality whenever the image is compressed and transmitted 32
for image interpretation. Means to ensure that the image is 33
properly identified and delivered in a timely manner to the 34
patient shall be provided. 35
5.5.3 Integration of PACS in the departmental workflow should 36
be provided. If PACS is available, the use of an electronic 37
source of identity, ordering and scheduling information, and 38
the integration of disparate sources of information shall be 39
provided. 40
5.5.4 The official interpretation of clinical images, emergency 41
examinations in on call situations and additional opinions 42
by external consultation shall be done by a physician with 43
qualifications stated in Appendix A. 44
Page 16 of 17
5.5.5 The x-ray facility shall notify the FDA all qualified 1
physicians or organization interpreting radiology images 2
through teleradiology. 3
4
6. Radiation Protection Requirements: 5
6
6.1. The radiation protection requirements on justification of the practice, dose 7
limitation, and optimization of protection and dose constraints as stated in 8
Section IV of A.O. 149 s. 2004 or as revised shall apply. 9
10
6.1.1 The owner/licensee shall ensure compliance to the dose limits for 11
planned exposure situation as provided in Appendix G of this 12
A.O. 13
14
6.1.2 The owner/licensee shall ensure compliance to the operational 15
requirements for medical, occupational and public exposure 16
situations as provided in Appendix H of this A.O. 17
18
6.2. Classification of Areas 19
20
Relevant areas of a practice can be classified as controlled or supervised. In 21
applying the requirements outlined in the International Basic Safety Standards 22
(IBSS), the following can be designated as a: 23
24
25
6.2.1 Controlled Area 26
6.2.1.1. All x-ray rooms shall be classified as controlled areas. 27
6.2.1.2. Arrangements for classifying areas where mobile 28
equipment is used during the time in which radiological work is 29
being carried out. 30
31
6.2.2.Supervised Area 32
6.2.2.1. Areas for staff circulation other than the x-ray room such 33
as the darkroom/image processing, reading/interpretation 34
and storage rooms, control booth, and internal corridors. 35
6.2.2.2. All areas surrounding the x-ray rooms. 36
6.2.2.3. Areas for circulation of patients such as reception, waiting 37
rooms, corridors from which the x-ray rooms can be 38
accessed through the dressing cabinets. 39
40
7. Quality Assurance Program (QAP) 41
42
7.1. As required in A.O. 149, s. 2004 or as revised, a comprehensive QAP 43
shall be established and maintained to ensure adequate assurance that the 44
specified requirements, quality control mechanisms and procedures relating to 45
the diagnostic uses and image quality from the use of x-ray imaging 46
Page 17 of 17
equipment is achieved. Guidelines for the establishment of a QAP is provided 1
in Appendix D of this AO or as revised. 2
3
7.2 A quality manual has to be prepared which shall be realistic and regularly 4
reviewed for relevance to existing practices. This shall be made available 5
during the conduct of RPSE and FCM. 6
7
VI TRANSITORY PROVISIONS 8
9
1. All existing x-ray facilities and facilities that are planning to put up an x-10
ray facility shall be given three (3) years from the effectivity date of this 11
AO to comply with the quality assurance program requirements as 12
specified in section V.B.7 13
2. All existing x-ray facilities shall be given three (3) years from the 14
effectivity date if this AO to comply with the x-ray machine requirements 15
as specified in Section V.B.4.2 and 4.3 16
3. All x-ray facilities classified as Level 3 needing the services of a CQMP 17
shall be given five (5) years to comply. 18
19
20
21
VII. AMENDMENT CLAUSE 22
23
Any amendment with respect to this Administrative Order shall be put in 24
writing. 25
26
27
VII SEPARABILITY CLAUSE 28
29
If any of the provisions of these regulations is found by a court of competent 30
jurisdiction to be void and unenforceable, in whole or in part, such provision shall be 31
deemed deleted from these regulations but the remaining provisions thereof shall 32
remain in full force and effect. 33
34
35
36
VIII REPEALING CLAUSE 37
38
All provisions of existing DOH administrative orders, circular, regulations and 39
other issuances inconsistent herewith are hereby repealed, amended, or modified 40
accordingly, provided that nothing in these regulations shall be deemed to modify the 41
existing regulations issued to special laws implemented by the FDA. 42
43
IX. PENALTY CLAUSE 44
45
Page 18 of 17
Any person or establishment found to violate any of the rules and regulations 1
set herein shall be imposed with the penalty prescribed in the Republic Act 9711 and 2
its Implementing Rules and Regulation. 3
4
X. EFFECTIVITY 5
6
This Order shall take effect fifteen (15) days upon publication in a newspaper 7
of general circulation and filed at the UP – Law Center, Office of the National 8
Administrative Register (ONAR). 9
10
*20170705162400* 11 20170705162400 12
13
FRANCISCO T. DUQUE III, MD 14
Secretary of Health 15
16
Page 19 of 17
Appendix A 1
QUALIFICATIONS OF MEDICAL RADIATION PRACTITIONERS 2
3
Classification of X-ray
Facility
Medical Radiation
Practitioner Additional Qualification
Chest for Heart and Lungs Diplomate of the Philippine
Board of Radiology (PBR) or
a fellow of the Philippine
College of Radiology (PCR)
in good standing
Fellow, Philippine College of
Chest Physicians
With additional training in
radiation protection
Non- radiologist physicians
doing image guided
fluoroscopic procedures
(orthopedic surgeons,
internists, urologists,
nephrologists and obstetric-
gynecologists)
With additional training in
radiation protection
Level 1 – Level 3 Diplomate of the Philippine
Board of Radiology (PBR) or
a fellow of the Philippine
College of Radiology (PCR)
in good standing
Non- radiologist physicians
doing image guided
fluoroscopic procedures
(orthopedic surgeons,
internists, urologists,
nephrologists and obstetric-
gynecologists)
With additional training in
radiation protection
Specialized Interventional Radiology:
Fellow of the Philippine
Society of Vascular and
Interventional Radiology
(PSVIR)
Fellow of the Philippine
Heart Association (FPHA)
with specialization in
interventional cardiology
Fellow of the Philippine
Society of Cardiac
Catheterization
Interventionalists (PSCCI)
PHA and PSCCI: With
additional training in
Radiation Protection in
Interventional Radiology
Page 20 of 17
Mammography:
Diplomate of the Philippine
Board of Radiology (PBR) or
a fellow of the Philippine
College of Radiology (PCR)
in good standing
Computed Tomography:
Diplomate of the Philippine
Board of Radiology (PBR) or
a fellow of the Philippine
College of Radiology (PCR)
in good standing.
Fellow, CT-MRI Society of
the Philippines
Bone Densitometry:
Member, Osteoporosis
Society of the Philippines.
Member, Philippine Society
of Nuclear Medicine
With additional training in
radiation protection
Lithotripsy:
Member, Philippine
Urological Association
With additional training in
radiation protection
Tumor Localization and
Simulation:
DPBR/FPCR
DPBR-RO
FPROS
1
Page 21 of 17
Appendix B 1
ROLES AND RESPONSIBILITIES OF A CLINICALLY QUALIFIED MEDICAL 2
PHYSICST IN DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY 3
(References: IAEA HUMAN HEALTH SERIES No. 25) 4
(a) Installation design, technical specification, acceptance and commissioning of 5
equipment, including the establishment of criteria for acceptable performance: Within 6
the technical specification, acceptance, commissioning and supervision of the proper 7
operation of equipment, and the establishment of criteria for its acceptable performance, the 8
following roles and duties must be considered: 9
(i) CQMPs are an essential part of the design team for new installations. They are 10
responsible for shielding and installation design of new or modified radiology rooms, 11
ensuring that all safety requirements are complied with. They calculate and provide 12
the thickness, material composition and placement of shielding needed to protect 13
patients, staff and the general public, and supervise the construction, thus 14
guaranteeing that all requirements of safety and functionality are met. They also 15
verify the adequacy of the shielding after installation. 16
(ii) CQMPs have a leading role in preparing equipment specifications and they 17
participate in the tender evaluation and purchase recommendation of equipment. They 18
perform analysis of the functional requirements for clinical use, and specify 19
conditions for integration, compatibility and connectivity of the equipment to be 20
purchased. 21
iii) Following the installation of new equipment, or after any significant change or 22
service, CQMPs are responsible for specifying the basic standards to be applied for its 23
acceptance and subsequent commissioning. They ensure that all units and systems 24
function according to their technical specifications and provide advice on any 25
deviation of equipment performance from acceptable criteria, including guidance on 26
decommissioning when appropriate. CQMPs also have, often in collaboration with 27
computer engineers, responsibility for the verification of the computer systems; they 28
assist medical practitioners in evaluating imaging or diagnostic algorithms for their 29
safe and effective clinical use. 30
(b) Radiation safety and protection of patients, staff and the general public: CQMPs 31
have responsibilities in the development and implementation of a clinical radiation safety 32
programme for the radiation protection of patients in areas where DIR equipment is used. In 33
the majority of cases, however, the CQMP also has responsibilities with respect to the 34
radiation safety of the staff and the public, as it pertains to the radiology service and 35
infrastructure. CQMPs are responsible for developing procedures for testing the integrity of 36
the equipment and accessories, for the proper operation of dosimetry equipment and other 37
safety features. They also participate in the investigation of incidents involving radiation and 38
they provide the appropriate report and documentation. 39
c) Patient dosimetry: CQMPs are responsible for establishing procedures for the calculation 40
and verification of the radiation dose received by the patient. Their duties include dosimetry 41
measurements as well as the development of methods to analyse the results of the 42
Page 22 of 17
measurements and verify the accuracy of doses delivered to patients. In special cases, duties 1
also involve individual patient dose calculations. Tasks related to patient dosimetry include: 2
i) Measurements and calculation of absorbed doses: CQMPs use data acquired during 3
commissioning and information from dosimetry measurements to estimate the 4
absorbed dose by patients during different clinical procedures. This requires the use of 5
analytical calculations, computerized models or in-phantom measurements. 6
Judgement with respect to the applicability of the models used and the ability to 7
synthesize new models is necessary, as well as knowledge to estimate dosimetry 8
uncertainties. 9
(ii) Specific patient dose calculations: CQMPs are responsible for the measurement 10
and/or calculation of individual patient doses and foetal doses in cases where a patient 11
is found to be pregnant. This may include detailed measurements. They establish 12
tolerances and make judgements on the appropriateness of the measured data, 13
including advice to the medical practitioner and the patient on any associated risks, 14
especially those related to the induction of cancer. 15
(iii) Patient dose estimations to establish diagnostic reference levels (DRLs), or to 16
verify conformity with recommended DRLs by national or international regulations: 17
CQMPs have responsibilities in reviewing procedures and equipment when DRLs are 18
consistently exceeded in standard procedures (d) Optimization of physical aspects of 19
diagnostic and interventional procedures: CQMPs have responsibilities in the 20
optimization of the physical and technical aspects of the different processes used to 21
produce medical images and the necessary imaging equipment (analogue and digital x 22
ray units, CT, angiography units, etc.). They also assist medical practitioners in the 23
evaluation of examination efficacy and participate in image quality and perception 24
studies. 25
(e) Quality management of the physical and technical aspects: CQMPs participate as team 26
members in establishing a quality management programme and have responsibility for the 27
physical and technical aspects. They are primarily responsible for developing and 28
implementing procedures for the initial and continuing evaluation of the DIR equipment as 29
well as for the calibration of dosimetry equipment. Related tasks comprise: 30
(i) Developing institutional policies and procedures for the continuous optimization of 31
radiation use, which includes responsibility for writing new policies and procedures, 32
or updating existing ones, related to: — Policies and procedures related to objectives, 33
such as improvement of quality of service, productivity of personnel, handling of new 34
equipment and information systems, and training of personnel; — Procedures related 35
to patient investigations, e.g. for patients with special needs, and review of patient 36
dosimetry information, immediately reporting any anomalous finding to the 37
responsible medical practitioner; — Procedures related to safety, e.g. procedures 38
related to radiation protection, personnel monitoring, reporting of incidents and 39
accidents, QA, and patient and personnel radiation dose and associated risks; — 40
Procedures related to equipment, for the immediate notification of equipment failure 41
to technical staff. 42
Page 23 of 17
(ii) Establishing a QA programme for verifying, setting and accepting the initial 1
reference values of parameters for optimal image quality and the initial reference state 2
of the imaging equipment: This includes developing and implementing QC, ensuring 3
that periodic QC measurements are carried out for the x ray units and associated 4
equipment for image visualization, processing, storage and printing. CQMPs are also 5
responsible for ensuring compliance of the imaging equipment with government and 6
accreditation agency regulations and recommendations. 7
(iii) Performing risk assessments and identifying possible radiation emergencies, such 8
as incidents resulting from equipment malfunction or human error: CQMPs develop 9
action procedures to be followed in the event of such occurrences and carry out drills 10
to verify that procedures can be carried out correctly. 11
(iv) Investigating unintended or accidental medical exposures, such as sentinel events 12
in interventional radiology: CQMPs provide consultation on the doses received by 13
patients or personnel and on the associated risks, and recommend measures to 14
minimize the chances for accidents to happen again. 15
(f) Collaboration with other clinical professionals: CQMPs are key members of the team 16
of clinical professionals, including radiological medical practitioners and other clinical 17
specialists, technologists and nursing staff, that work together for the diagnosis and treatment 18
of patients. The contribution of medical physicists in this respect includes: 19
(i) Consultations to medical practitioners on special patient cases that may be 20
encountered during diagnostic or interventional procedures that require additional 21
actions to those routinely established: The collaboration between the medical 22
practitioners and the CQMPs helps in establishing the optimal approach for each case. 23
(ii) Supervision of the technologists in the implementation of new clinical procedures, 24
being key members of the team responsible for the introduction of new clinical 25
procedures in the institution: CQMPs are also responsible for developing methods for 26
QA of the new procedures. 27
28
29
30
31
32
33
34
35
36
37
38
Page 24 of 17
Appendix C 1
RADIATION PROTECTION PROGRAMME IN DIAGNOSTIC RADIOLOGY 2
(Adapted from IAEA Safety Report Series No. 39) 3
4
The radiation protection programme of the diagnostic x-ray facility shall include the 5
following information: 6
I. General Information of the Facility 7
a. Description of the whole facility including the services it offers. 8
b. Description of the radiology department, equipment, radiology services, and patient 9
workload. 10
c. Organizational structure including the management commitment on compliance to 11
regulatory requirements and the practice of radiation protection. 12
d. Number of staff involved in the operation of the x-ray facility. Provisions to ensure 13
that only qualified personnel assume the responsibility for using radiation. 14
e. Appointment of the radiation protection officer and its qualification. 15
f. Roles and responsibilities of the RPO, diagnostic radiology medical physicist, and 16
radiologic technologists. Provisions that these roles and responsibilities are 17
understood by personnel concerned. 18
19
II. Radiation Protection Program 20
A. Security of X-ray Sources 21
1. Describe the procedure for inventory of all x-ray equipment and policy to prevent 22
unauthorized access and use of x-ray machines. 23
2. Describe the rules and procedures for purchasing, use, and repairs of the x-ray 24
equipment. 25
26
B. Protection for Occupational Exposure 27
1. Provisions to inform the workers about their obligations and responsibilities for 28
their own protection and the protection of others against radiation exposure and 29
for the safety of sources. 30
2. Description of the policy on pregnant workers. 31
3. Classification/Identification of controlled and supervised areas including the 32
policies on the access of these areas. Arrangements for classifying areas where 33
mobile equipment is used during the time in which radiological work is being 34
carried out. 35
4. Local Rules and Supervision - Procedures for ensuring adequate levels of 36
protection and safety of workers; Provisions to make sure that these procedures, 37
the protective measures, and safety provisions are known to those workers to 38
whom they apply and to other persons who may be affected by them; Supervision 39
to ensure observance of the procedures; and Investigation levels in place. 40
5. Describe the procedure for inventory of personal protective equipment including 41
the policy on their proper use. 42
6. Individual monitoring and exposure assessment – Discuss the arrangements to 43
provide individual personnel radiation dose monitoring from an accredited service 44
provider. This includes the identification of staff members requiring individual 45
Page 25 of 17
monitoring; Establishment of the monitoring period, frequency for reading and 1
recording the accumulated doses, and rules for returning and changing dosimeters. 2
Provisions to ensure that details of doses are made available to the staff and 3
procedures for estimating the worker’s dose if a personal dosimeter is lost or 4
damaged. 5
7. Health Surveillance – Describe the program for health surveillance of workers 6
based on general principles of occupational health designed to assess the initial 7
and continuing fitness of workers for their intended tasks. 8
9
C. Protection for Medical Exposure 10
1. Responsibilities — Assignment of the overall responsibility for patient protection 11
and safety to a medical practitioner; Assignment of the responsibility for 12
conducting or supervising calibration of equipment, clinical dosimetry and QA to 13
a qualified expert on diagnostic radiology physics; Provision and documentation 14
of continuous education and training of all staff; Training shall include lessons 15
from accidents and their prevention included in the training. 16
2. Justification of medical exposure — Describe the policies and procedure in place 17
for the prescription and administration of medical exposure to ensure that these 18
are justified; If applicable, indicate the department’s policy to justify research 19
involving application of radiation on humans. 20
3. Optimization – Policy for optimization to ensure that the exposure of patients is 21
the minimum required to achieve the intended diagnostic objective, taking into 22
account relevant information from previous examinations in order to avoid 23
unnecessary additional examinations, and taking into account the relevant 24
guidance levels for medical exposure. 25
4. Clinical Dosimetry – procedures in the determination of representative values for 26
average sized adult patients of entrance doses, dose area products, dose rates, or 27
organ doses. 28
5. Investigation of accidental medical exposure - Policies in place to investigate and 29
report: (a) Any diagnostic exposure substantially greater than intended or resulting 30
in doses repeatedly and substantially exceeding the established guidance levels; 31
and (b) any equipment failure, accident, error, mishap or other unusual occurrence 32
with the potential to cause a patient exposure which is significantly different from 33
that intended; Provisions to estimate the doses received, and indicate and 34
implement corrective measures and to follow-up of patients who received high 35
exposure procedures with the potential for deterministic effects, such as prolonged 36
interventional procedure. 37
38
D. Protection for Public Exposure - Shielding design with due consideration of public 39
exposure; Control of access of public and visitors in place; Design of pathways 40
designed to minimize interference from the public with console control space and 41
radiology rooms to avoid potential exposure. 42
43
44
45
Page 26 of 17
Appendix D 1
QUALITY ASSURANCE PROGRAM 2
The responsibility for long-range planning of quality assurance goals and activities shall be 3
assigned to the QA/QC committee especially for large facilities. 4
5
1. Requirements of a Quality Assurance Program (QAP): 6
7
Implementation, monitoring and overall quality assurance program of the 8
institution/facility is one of the primary responsibilities given to the licensee. The licensee 9
shall ensure the following: 10
11
1.1 Creation of a QA/QC Committee. 12
13
Creation of this committee ensures the commitment for the establishment and 14
maintenance of a quality assurance program. This committee shall be responsible for all 15
the QA activities in the radiology department. The QA/QC committee shall be composed 16
of the following personnel/staff in a radiology department: 17
18
a. Head of the X-ray Facility 19
b. Medical Physicist, if available 20
c. Chief Radiologic Technologist 21
d. Radiologic Technologists 22
e. Resident physician/s 23
f. other radiology staff (e.g. nurses, administrative staff, etc.) 24
25
Each member shall have clearly identified roles and responsibilities and should be 26
documented. Meetings regarding QA/QC must be conducted periodically. Records of 27
the minutes of the meetings must be kept. 28
29
1.2 Establishment of Standards or Criteria in the Evaluation of 30
Radiographs/Images per x-ray examination or procedures performed in the x-ray 31
facility. 32
33
Each x-ray examination performed in the facility shall have basis for classifying 34
radiographs as either good, poor or reject. It is the responsibility of all the 35
radiologists to come up with standards/criteria in the classification of 36
radiographs/images. 37
38
1.3 Conduct of an Image/Film Analysis Program. 39
40
This shall be done prior to and after the establishment of a QAP. Film/image 41
analysis is conducted to ensure the reduction of repeated radiographs. Monthly 42
reports of film analysis shall be kept and reviewed by the QA/QC Committee to verify 43
frequent causes of poor and reject images, which shall consequently initiate corrective 44
actions and improvement of the image quality. 45
Page 27 of 17
1
1.4 Formulation of a Standard Radiographic Technique Chart per X-ray equipment. 2
3
A standard radiographic technique chart shall be formulated for each x-ray 4
equipment. The chart shall be posted in a conspicuous place in the control console 5
booth. A copy of the technique parameters for the x-ray procedures shall be kept for 6
anatomically programmed x-ray equipment. 7
8
1.5 Formulation/Development of a Quality Assurance Manual. 9
10
The quality assurance manual should be written in a format permitting convenient 11
revision as needed. It should be made readily available to all personnel. The content 12
of the manual should be determined by the facility staff. The quality assurance manual 13
should also be reviewed, at least annually, to determine effectiveness and 14
improvement of the QAP. The manual shall contain the following: 15
1.5.1 List of the individuals responsible for the monitoring and maintenance of 16
QAP; 17
1.5.2 Description of the radiographic examinations performed and standard 18
operating procedures, including a description of the standards, criteria of 19
quality, or limits of acceptability for images/radiographs; 20
1.5.3 Description of the quality control procedures and criteria of acceptability for 21
each x-ray equipment; 22
1.5.4 Description of procedures to be followed when errors are detected; 23
1.5.5 Description of appropriate training to be attended by all personnel involved 24
with quality assurance responsibilities; 25
1.5.6 Description of the standards for image quality to ensure that they are 26
consistent with the needs and resources of the facility; 27
1.5.7 Description of the preventive maintenance program for each x-ray equipment; 28
and, 29
1.5.8 Description of service arrangement with other organizations and qualified 30
experts. 31
1.6 Maintenance of room logs containing the records of quality control (QC) test results 32
per x-ray equipment, darkroom accessories and other ancillary equipment e.g. laser 33
printers, CR readers, etc. 34
1.7 Records of maintenance and repair work for each x-ray equipment. 35
1.8 Provisions of appropriate training for all personnel with responsibilities to 36
quality assurance program. 37
38
2. Scope of a Quality Assurance Program: 39
40
The QAP shall include: 41
42
2.1. Image quality assessments: Image quality assessments are assessed by 43
quantitative measurements and clinical images based on anatomical criteria. 44
2.2. Image reject analysis/Reject Analysis Program: This has to be performed 45
prior to the establishment of QAP and thereafter. Image quality criteria shall be 46
Page 28 of 17
discussed among the radiologists and radiologic technologists so as to come up with a 1
standard image quality and radiographic techniques. 2
2.3. Provision for Comfort and Privacy of Patients. Analysis of patient waiting 3
time, clean and well-ventilated room as well as provision of clean and comfortable 4
patient gown, linen, pillows and couch is of importance in this aspect 5
2.4. Patient dose evaluations. Establishment of reference doses based on the output 6
measurements conducted on the x-ray equipment and the technique parameters used 7
for each x-ray procedure. 8
2.5. Periodic Quality Control Program for all X-ray Units: Quality Control 9
includes the visual/mechanical inspection and performance testing of all available x-10
ray units and accessories in the hospital/institution. 11
2.6. Monitoring and maintenance: Routine quality control monitoring and 12
maintenance procedures for x-ray equipment and accessories shall be established and 13
conducted on a regular schedule. The purpose of monitoring is to permit evaluation of 14
the performance of the facility’s x-ray system/s in terms of the standards for image 15
quality established by the facility and compliance with the relevant regulatory 16
requirement/s. The maintenance program should include preventive maintenance, 17
which could prevent unexpected breakdowns of equipment and disruption of 18
departmental routine. This should also include corrective maintenance to eliminate 19
equipment problems before they have a serious deleterious impact on patient care. 20
2.7. Verification and review of the appropriate physical and clinical factors used 21
in patient’s diagnosis of diseases. 22
2.8. Written records of relevant procedures and results. 23
24
3. Quality Control (QC) Program: 25
26
Identification of the various parameters to be monitored in a radiography, 27
fluoroscopy, CT, mammography, and interventional radiography equipment that greatly 28
affects both the image quality and its performance shall be carried out prior to the 29
establishment of QCP. 30
31
Routine Performance testing and QC comprises those tests that are undertaken either 32
regularly or after maintenance or repairs, to detect whether any change in the performance of 33
the equipment has occurred that would require corrective action. 34
35
Routine performance tests are really a subset of the commissioning tests and will 36
generally involve staff with different levels of expertise, some of whom may be external to 37
the radiology facility. The more frequent tests that are to perform are usually undertaken 38
locally with advice from a medical physicist, while the more complex and time consuming 39
tests may require special expertise and instrumentation. A collaborative, multidisciplinary 40
approach to routine performance testing is essential. 41
42
Outline of QC Tests: 43
44
Page 29 of 17
These tests are intended to verify the stability in the operation of the equipment or 1
elements used to acquire the image. The tests can be described in three ways with some of 2
their key characteristics described below: 3
4
3.1 Frequency-The recommended frequency of a routine performance test varies from 5
daily to yearly. It is often given as a range (e.g. three to six monthly) because the 6
frequency selected should depend on the equipment characteristics (e.g. age 7
reliability) and the clinical workload to which the equipment is subjected. A 8
lower frequency of tests may be appropriate for simple imaging equipment that is 9
used less frequently or for equipment where experience shows that parameters are 10
unlikely to change. The frequency of tests may also be designated as essential and 11
desirable, for example, a test may be essential every year but desirable every six 12
months. 13
14
3.2 Priority: The priorities for indicating whether a routine performance test is 15
recommended may be denoted as: 16
17
3.2.1 Essential: Represents the minimum recommended standard; 18
conformance to this standard of testing would be regarded good 19
practice. 20
3.2.2 Desirable: The inclusion of this level of testing would be regarded as 21
best practice. However, it is recognized that the implementation of 22
these tests may be constrained by test equipment costs, personnel 23
availability, equipment characteristics, clinical workload or other 24
factors. 25
26
3.3 Performance standards: QC tests help maintain equipment performance through 27
the use of tolerance criteria that are applied to QC test results. These performance 28
standards can be characterized as acceptable and achievable; 29
30
3.3.1 Acceptable: Indicates that performance must be within these 31
tolerances and if it is not, the equipment should not be used. 32
33
3.3.2 Achievable: Indicates the level of performance that should be attained 34
under favorable circumstances; if feasible, this is the level at which a 35
facility should work. 36
37
38
39
40
41
42
43
44
Page 30 of 17
1
2
3
4
Appendix E 5
SPECIFIC X-RAY MACHINE REQUIREMENTS AND ACCESSORIES 6
7
8
A. SPECIFIC X-RAY MACHINE REQUIREMENTS: 9
10
1. Radiographic/Fluoroscopic X-ray Machines 11
12
1.1. For digital radiography systems, a program/software that automatically stores 13
rejected images into an image reject folder shall be provided. Such folder shall 14
only be accessible to the medical physicist or quality control technologist. 15
1.2. Fluoroscopy machines shall be provided with: 16
1.2.1 user selectable mode of operations such as low dose, normal, or high dose 17
fluoroscopy, and pulsed fluoroscopy. 18
1.2.2 Where practicable, protective materials shall be affixed to the x-ray 19
equipment or otherwise installed in such a way as to be interposed between 20
sources of scattered radiation and x-ray personnel. These materials shall have 21
a lead equivalence of not less than 0.5 mm. Protective materials shall be 22
effective in any position of the image intensifier assembly. They shall not 23
obstruct palpation or other necessary manipulation of the patient. 24
1.2.3 For remote controlled fluoroscopy systems, a protective barrier shall be 25
provided for the operator. 26
1.2.4 Image intensification device shall be provided on all fluoroscopic equipment. 27
The use of direct viewing fluoroscopes shall not be allowed. 28
1.2.5 Fluoroscopic devices shall be equipped with a last image hold system which 29
keeps on display the last fluoroscopic image obtained. 30
31
2. Mammography X-ray Machine 32
33
a. A permanent radiation protection barrier for the technologist shall be provided. The 34
lead viewing glass of the barrier shall have a lead equivalence of at least 0.3 mm 35
b. A mechanical compression and decompression device shall be provided. The paddle 36
shall be flat with minimal chest wall radius and shall remain parallel to the breast 37
support at an acceptable compression force. It shall automatically release the 38
compression force after radiation exposure. 39
c. An indicator of breast thickness and compression force shall be made available. 40
d. A face shield used to restrict the head of the patient from the useful radiation beam 41
shall be provided. 42
43
3. Computed Tomographic Machine 44
3.1. A slice positioning light localizer shall be provided. 45
Page 31 of 17
3.2. An emergency stop switch shall be provided on or near the patient support and/or 1
gantry to immediately terminate the motion of the equipment and the emission of X-2
rays. 3
3.3. Information of the accumulated radiation dose per CT procedures should be 4
displayed in the image acquisition monitor. 5
3.4. Controls to adjust the position of the couch shall be provided in the gantry. 6
7
4. For interventional radiology, bone densitometry, and lithotripsy, requirements for 8
radiographic and/or fluoroscopic machines shall apply. 9
10
5. For tumor localization and simulation utilizing conventional x-ray machines, requirements 11
for radiography and/or fluoroscopy machines shall apply. 12
13
6. Digital imaging systems shall be equipped with the following: 14
15
6.1. Image acquisition system which shall be of direct image detector, indirect image 16
capture using computed radiography, or medical grade radiographic film scanner 17
with a minimum of 2.5 lp/mm for general radiography and 5.0 lp/mm for 18
mammography. Image acquisition systems shall be compliant to Digital Imaging 19
and Communications in Medicine (DICOM) standards. 20
6.2. Workstation monitors to display and process newly acquired x-ray images. The 21
workstation shall be capable to display patient demographics, contrast adjustment, 22
magnification and pan functions, rotation or flipping of images, measurements, and 23
calculation and display of appropriate pixel value or exposure indicators. 24
6.3. Medical grade image displays to be used for the interpretation of x-ray images. The 25
monitors shall have a resolution of at least 2 megapixels except for mammography 26
which shall have at least 5 megapixel of resolution. 27
6.4. Image archiving, retention, and retrieval system appropriate and compliant with the 28
requirements for teleradiology. 29
6.5. Ambient operating temperatures between 18° and 30° Celsius and between 20% and 30
80% condensing humidity shall be maintained since digital devices are based on 31
electronics and are computer controlled. 32
33
B. REQUIRED ACCESSORIES FOR SPECIFIC X-RAY MACHINES: 34
35
Where applicable, each x-ray machine shall be provided with the following 36
radiological accessories: 37
38
1. For general radiography and fluoroscopy. 39
1.1. A caliper to measure the thickness of the patient. 40
1.2. A set of contact gonad shields for male, female and infant with a 41
minimum lead equivalence of 0.25 mm. 42
1.3. A pair of lead rubber gloves with minimum lead equivalence of 43
0.25 mm. 44
1.4. A lead rubber apron with minimum lead equivalence of 0.25 mm. 45
46
Page 32 of 17
For fluoroscopy, each personnel present during fluoroscopic examination 1
shall be provided with the following: 2
1.5. A wrap around lead rubber apron with minimum lead equivalence 3
of 0.25 mm. 4
1.6. Thyroid shields with minimum lead equivalence of 0.25 mm. 5
1.7. Lead goggles with a minimum lead equivalence of 0.2 mm. 6
7
2. For computed tomography 8
2.1. A quality assurance phantom and other ancillary equipment 9
necessary for the conduct of routine quality assurance program 10
shall be provided. This is to assure that the performance of the 11
computed tomography system is reproducible within a range 12
specified by the particular manufacturer. 13
2.2. Automatic contrast injector shall be provided. 14
2.3. A lead rubber apron with minimum lead equivalence of 0.25 mm. 15
2.4. Thyroid shields with minimum lead equivalence of 0.25 mm. 16
17
3. For Mammography 18
3.1. A quality assurance phantom and other ancillary equipment 19
necessary for the conduct of routine quality assurance program 20
shall be provided. This is to assure that the performance of the 21
mammography system is reproducible within a range specified by 22
the particular manufacturer. 23
3.2. Densitometer and sensitometer shall be provided. For digital 24
mammography units, sensitometer is not required. 25
26
Page 33 of 17
Appendix F 1
2
Table 1. Minimum Performance Criteria for X-ray Equipment 3
4
Type of
Equipment Test Parameters Performance Criteria
General
Radiography
Radiographic/
Fluoroscopy,
Lithotripsy, bone
densitometry and
interventional
radiology
Visual/Mechanical Checks
Collimation Accuracy:
-Check for X-ray and light field
misalignment
-Check for x-ray field and
image receptor misalignment
Generator Tests:
-Check for kVp Accuracy and
Reproducibility
-Check for Output
Reproducibility
-mA or mAs Linearity Check
For the radiography mode: same as
the tests for general radiography.
For Fluoroscopy:
-Collimation Accuracy
All moving parts shall be properly
working and free from obstruction.
Surfaces in contact with the patient
shall be smooth. Cables shall be
properly kept.
The total misalignment shall be within
±2% of SID. Each side shall be within
±1% of SID.
The misalignment between
x-ray field and image receptor
shall be within ±1 % of the SID
For 100 kVp and below: The actual
kVp shall be within ±6% of the set
kVp.
For 101 kVp and above: The actual
kVp shall be within ± 6 kVp of the set
kVp.
-The coefficient of variation (COV)
for the output measurements shall be
within 0.05.
-The overall coefficient of linearity
shall be ≤ 0.1
-Same as the criteria for the general
radiography.
-The edges of the collimation for
fluoroscopy shall be visible. If not
visible, the measurement of the
Page 34 of 17
Computed
Tomography
-Auto Collimation Function
Test (This test is done if the
SID is variable only)
Generator Tests:
-Check for “Fluoroscopy” kVp
Accuracy and Reproducibility
-Check for output reproducibility
-Maximum Fluoroscopic Exposure
Rate
-Check for Maximum
Fluoroscopic Time
-Visual and Mechanical Checks
Scan Localization Light Accuracy
-Patient Table Position
collimation shall be less than the field
sizes of the image intensification.
-The size of the collimation shall be
the same regardless of SID setting.
For 100 kVp and below: The actual
kVp shall be within ±6% of the set
kVp.
For 101 kVp and above: The actual
kVp shall be within ± 6 kVp of the set
kVp.
The coefficient of variation (COV) for
the set kVp measurements shall be
within 0.05.
The coefficient of variation (COV) for
the output measurements shall be
within 0.05.
The intensity of x-ray beam at tabletop
shall not exceed 10 R/min for units
equipped with ABS and 5 R/min for
units without ABS.
An audible signal shall be activated
whenever the 5 minute fluoroscopy time
is reached. Means shall be provided to
reset the fluoroscopy time.
All switches and buttons shall be
functioning properly. Patient couch shall
move smoothly and free from
obstructions.
The misalignment between the scan plane
and the scan localization light position
shall be within ±2 mm.
The maximum “in” and “out” movement
Page 35 of 17
Mammography
Reproducibility
-CT Number Accuracy
-CT Number Uniformity
-Visual/Mechanical Checks
-Check for the compression device
-Check for the Collimation
Accuracy
Generator Tests:
-Check for the kVp Accuracy
and Reproducibility
shall be reproducible within ± 1 mm.
The CT Number of air shall be within
1000±100 HU; while the CT Number
for water is 0±4 HU
The CT numbers of the outer ROIs in
the peripheries shall not deviate from
the central ROI by ±2 HU.
All moving parts, switches, knobs and
buttons shall be properly working and
free from obstruction. Accessories and
surfaces in contact with the patient
shall be smooth. Cables shall be
properly kept.
The initial compression force shall be
25 lbs. and the maximum compression
force shall not exceed 45 lbs.
The decompression device shall
automatically release the breast
compression after the radiation
exposure or when necessary.
The total misalignment shall be within
±2% of SID. Each side shall be within
±1% of SID.
The edge of the compression paddle
shall not be seen on the image receptor
and shall be projected beyond the
chest wall edge of the image receptor
by more than ±1%SID.
The actual kVp shall be within ±5% of
the set kVp. The COV of all the
measurements for the set kVp shall be
≤0.05.
Page 36 of 17
-Check for the output
reproducibility
-AEC Performance Assessment
-Image Quality Evaluation
-Measurement of Average
Glandular Dose
The coefficient of variation (COV) for
the output measurements shall be
within 0.05.
The AEC shall be capable of
maintaining the optical density within
± 0.15 or MPV by ±15 % when the
thickness of the phantom is varied
from 2-6 cm and the kVp is varied
over the range of those used clinically
for those thicknesses.
The criteria set by the phantom
manufacturer for image quality
evaluation shall be followed.
The average glandular dose shall not
exceed 3 mGy per view for image
receptor with grid and 1 mGy for
image receptor without grid.
1
Table 2. Frequency of testing 2
X-ray Machine Frequency of Performance Testing
General Radiography and/or Fluoroscopy Once every Four years
Bone Densitometry Once every Four years
Lithotripsy Once every Four years
Mammography Once every Two years
Interventional Radiology Machine Once every Two years
Computed Tomography Once every Two years
Tumor Localization and Simulation Once every Two years
3 4
Page 37 of 17
1
APPENDIX G 2 3
DOSE LIMITS FOR PLANNED EXPOSURE SITUATIONS 4 (Reference: IAEA GSR Part 3 Schedule III) 5
6
OCCUPATIONAL EXPOSURE 7 8
1. For occupational exposure of workers over the age of 18 years, the dose limits are: 9 10
a. An effective dose of 20 mSv per year averaged over five consecutive years1 (100 11 mSv in 5 years) and of 50 mSv in any single year; 12
b. An equivalent dose to the lens of the eye of 20 mSv per year averaged over five 13
consecutive years (100 mSv in 5 years) and of 50 mSv in any single year; 14 c. An equivalent dose to the extremities (hands and feet) or to the skin2 of 500 mSv 15
in a year. 16 17 Additional restrictions apply to occupational exposure for a female worker who has notified 18
pregnancy or is breast-feeding (Section --- AO on GSR Part 3). 19 20
PUBLIC EXPOSURE 21 22
2. For public exposure, the dose limits are: 23 24
a. An effective dose of 1 mSv in a year; 25
b. In special circumstances, a higher value of effective dose in a single year 26
could apply, provided that the average effective dose over five consecutive 27 years does not exceed 1 mSv per year; 28
c. An equivalent dose to the lens of the eye of 15 mSv in a year; 29 d. An equivalent dose to the skin of 50 mSv in a year. 30
31
__________________________ 32 1 The start of the averaging period shall be coincident with the first day of the relevant annual period after the 33 date of entry into force of these Standards, with no retrospective averaging. 34 2 The equivalent dose limits for the skin apply to the average dose over 1 cm2 of the most highly irradiated area 35 of the skin. The dose to the skin also contributes to the effective dose, this contribution being the average dose to 36 the entire skin multiplied by the tissue weighting factor for the skin. 37
38
Page 38 of 17
Appendix H 1
2 GUIDELINES ON OPERATIONAL REQUIREMENT FOR THE SPECIFIC 3
RADIATION EXPOSURE CATEGORIES 4 5
1. Medical Exposures: 6
7
1.1.All x-ray examination shall be performed only when necessary for obtaining 8
diagnostic information. 9
1.2. If two or more medical x-ray examinations that provide the appropriate 10
diagnostic information are readily available, then the procedure that yields the 11
least overall risk to the patient shall be chosen. 12
1.3. Any radiological examination for occupational, legal, or health insurance 13
purposes that are undertaken without reference to clinical indications, shall 14
deemed to be not justified, unless it is expected to provide useful information 15
on the health of the individual examined, or unless the specific type of 16
examination is justified by those requesting it in consultation with relevant 17
professional bodies. 18
1.4. Mass screening of population groups involving medical exposure is deemed to 19
be not justified unless the expected advantages for the individual examined or 20
for the population as a whole are sufficient to compensate for the economic 21
and social costs, including radiation detriment. 22
1.5. A medical x-ray examination shall only be performed if there is a request from 23
a referring physician. However, when a physician refers a patient for an 24
imaging procedure, it should be understood that the patient is being referred 25
for an opinion. If there is a significant risk to the patient or it is believed that 26
such a request is inappropriate, it is both the right and duty of the qualified 27
medical radiation practitioner as described in Section V. B. item 3.3.1 to 28
refuse to undertake any particular procedure. A legitimate and logical reason 29
for such refusal shall be provided to the referring physician. 30
1.6. All x-ray examinations shall be performed only by or under the immediate 31
supervision of qualified personnel described in Section V.B. item 3.3.4. 32
1.7. Requests for x-ray examination shall be signed by the referring physician and 33
shall include the following information in legible form: 34
1.7.1 Patient’s name, age, sex, status and address 35
1.7.2 Date of request, brief clinical history and examination requested. 36
1.7.3 Tentative diagnosis 37
1.7.4 Name and signature of referring physician 38
1.8. Protocols on patient referral shall be documented. Where practicable, x-ray 39
examinations shall be performed inside a room that is properly shielded in 40
accordance with Section V.B item 5.2 41
1.9. A radiographic technique established by the radiologic technologist and 42
approved by the medical radiation practitioner shall be provided for each x-43
ray machine. 44
Page 39 of 17
1.10. The technique chart signed by the radiologic/xray technologist and the 1
medical radiation practitioner should be posted in a conspicuous place near 2
the control console. 3
1.11. Doors leading to the x-ray examination room shall be closed during the 4
conduct of x-ray examinations. 5
1.12. All x-ray examination shall be performed with a properly functioning x-ray 6
machine. 7
1.13. In order to minimize the frequency of unintentional irradiation of the embryo 8
or fetus, the following advisory notice shall be posted at several places 9
within diagnostic x-ray department and other areas where diagnostic x-ray 10
equipment is used: IF IT IS POSSIBLE THAT YOU MIGHT BE 11
PREGNANT,NOTIFY THE PHYSICIAN OR RADIOLOGIC/X-RAY 12
TECHNOLOGIST BEFORE YOUR X-RAY EXAMINATION. 13
1.14. When a pregnant woman is required to undergo an x-ray examination in 14
which the x-ray beam irradiates the fetus directly, special care has to be 15
given and that it should not be delayed until after the pregnancy. Sometimes 16
the radiation risk to the fetus is less than that of not making the necessary 17
diagnosis, so that the x-ray examination should still be done when medical 18
indications are appropriate. In such cases, greater than usual care should be 19
taken to minimize the absorbed dose in the fetus for each irradiation. 20
However, alterations of technique should not reduce unduly the diagnostic 21
value of the x-ray examination. 22
1.15. Sensitive body organ (e.g. lens of the eye, gonads) shall be shielded 23
whenever they are likely to be exposed to the useful beam provided that such 24
shielding does not eliminate useful diagnostic information. 25
1.16. When patients must be held during examinations, all efforts shall be 26
undertaken to avoid having assistance provided by persons who work within 27
the x-ray department. 28
1.17. No pregnant woman or persons under the age of 18 years shall be permitted 29
to hold patients. 30
1.18. Persons holding the patients shall wear protective aprons and gloves. Even if 31
protective clothing is worn, those holding the patients shall make sure as far 32
as practicable, that no part of their body, even if covered by protective 33
clothing is in the path of the useful beam. 34
1.19. Only persons whose presence is necessary shall be in the x-ray room during 35
exposures. All such persons shall wear appropriate protective devices. All 36
medical x-ray examinations shall have written results signed by the qualified 37
medical radiation practitioner as given in Section V. B. item 3.3.1 38
1.20. The written result shall reflect the name and signature of the radiologic/x-ray 39
technologist who performed the radiographic examination. 40
1.21. Fluoroscopy shall not be used as a substitute for radiography. 41
1.22. During the use of the computed tomography machine, the slice thickness 42
shall be as big as possible and the number of slices shall be as small as 43
practicable. 44
Page 40 of 17
1.23. During mammographic procedures, the proper compression of the breast 1
shall be observed. 2
1.24. For mobile radiography, the radiologic/x-ray technologist shall ensure that 3
no person other than the patient will be exposed to the useful beam. 4
5
2. Occupational Exposures: 6
7
2.1. The radiologic/x-ray technologist shall wear a personal monitoring device. 8
2.2. The radiologic/x-ray technologist shall stay behind the protective barrier and 9
shall observe the patient during x-ray examination. 10
2.3. Protective aprons and thyroid shields shall be worn in the fluoroscopy room 11
by each person, except the patient. People who must move around the room 12
during the procedure shall wear a wrap-around protective apron. 13
2.4. Mobile x-ray machine shall be used only when it is not possible to transfer 14
patients to fixed installations. If this were the case, the technologists and the 15
other persons within the area shall stay at least 2 meters from the patient, the 16
x-ray tube and the useful beam. 17
2.5. During the use of a mobile x-ray machine the radiologic/x-ay technologist 18
shall wear a protective apron with 0.25 mm lead equivalence. 19
2.6. For occupational exposure of workers over the age of 18 years, the dose 20
limits are: 21
22
2.6.1 An effective dose of 20 mSv per year averaged over five 23
consecutive years (100 mSv in 5 years) and of 50 mSv in any single 24
year; 25
2.6.2 An effective dose to the lens of the eye of 20 mSv per year averaged 26
over five consecutive years (100 mSv in 5 years) and of 50 mSv in 27
any single year; 28
2.6.3 An equivalent dose to the extremities (hands and feet) or to the skin 29
of 500 mSv in a single year. 30
2.7 For occupational exposure of apprentices of 16 to 18 years of age who are 31
being trained for employment workers over the age of 18 years, the dose 32
limits are: 33
34
2.7.1 An effective dose of 6 mSv in a year; 35
2.7.2 An effective dose to the lens of the eye of 20 mSv in a year; 36
2.7.3 An equivalent dose to the extremities (hands and feet) or to the skin 37
of 150 mSv in year. 38
39
40
41
42
43
44
45
46
Page 41 of 17
3. Public Exposures 1
2
3.1. All areas accessible to the members of the public shall be situated away from 3
the x-ray examination rooms. 4
3.2. The walls of the x-ray examination room near the waiting area shall be 5
properly shielded from scattered radiation. 6
3.3. For public exposure, the dose limits are: 7
3.3.1 An effective dose of 1 mSv in a year. 8
3.3.2 In special circumstances, a higher value of effective dose in a single 9
year could apply, provided that the average effective dose over five 10
consecutive years The dose to the members of the public shall not 11
exceed 1 mSv/year. 12
3.3.3 An equivalent dose to the lens of the eye of 15 mSv in ayear; 13
3.3.4 An equivalent dose to the skin of 50 mSv in a year. 14
15
Page 42 of 17
Appendix I 1
2
DUTIES AND RESPONSIBILITIES OF A RADIATION PROTECTION OFFICER 3
4
Establish, implement, maintain and administer a radiation protection program of the 5
facility. 6
Prepare and or revise a radiation protection manual. 7
Ensures that all relevant regulations and license conditions are followed. 8
Arranges and administers appropriate individual and workplace monitoring and 9
ALARA programs for practices and interventions of the facility. 10
Assess, review and keep records of the individual and workplace monitoring reports. 11
Institutes education and training of personnel in radiation protection. 12
Determines the shielding required for new or renovated equipment rooms for ionizing 13
radiation. 14
Design of special shielding devices. 15
Facilitates compliance with all regulating and certifying agencies, Commission, Joint 16
Commission on the Accreditation of Healthcare Organizations, Occupational Safety 17
and Health Administration, and appropriate state and local agencies) 18
Review of policies and procedures related to radiation safety and action levels. 19
20
21
22
23
Page 43 of 17
Appendix J 1
DUTIES AND RESPONSIBILITIES OF A QUALITY CONTROL TECHNOLOGIST 2
All staff in the radiology department should be involved in quality control. However, specific 3
tests are usually performed more effectively by specially trained technologists. The amount 4
of time spent on QC should be adequate to perform the functions required for an effective 5
quality control program. QC technologists should be allowed to devote at least 50 per cent of 6
their time to a QC program in small institutions (200 beds or less) and full time in larger 7
institutions. Institutions with more than 500 beds may require additional help. Among the 8
activities of the QC technologist(s) should be to: 9
1. Carry out the day-to-day QC tests on the department's photographic, radiographic and 10
fluoroscopic imaging equipment as prescribed by the QC test schedule; 11
2. Record and/or chart the QC test measurement data; 12
3. Evaluate the test results; 13
4. Report any deterioration or trends in equipment performance to the radiology 14
manager and staff using the equipment; 15
5. Initiate prompt corrective action and/or preventive measures when necessary; 16
6. Oversee the repair of defective equipment performed by the hospital biomedical or 17
electronic maintenance staff or by private service companies; 18
7. Perform the required tests to confirm that defective equipment was repaired and 19
restored to the original level of performance; 20
8. Maintain equipment performance records; 21
9. Provide monthly reports on QC activities to the radiology manager; and 22
10. Develop new QC monitoring and maintenance procedures as required. 23
24
Page 44 of 17
Appendix K 1
2
SAFETY ASSESSMENT PLAN FOR MEDICAL X-RAY FACILITIES AND 3
PRACTICES 4
(References: IAEA GSR PART IV-Rev. 1 2016) 5
6
7
Safety has to be assessed for all facilities and activities, consistent with a graded approach. 8
Safety assessment plan involves the systematic analysis of normal operation and its effects, of 9
the ways in which failures might occur as a consequence of such failures. Safety assessment 10
plan plans cover the safety measures necessary to control the hazard, and the design and 11
engineered safety features are assessed to demonstrate that they fulfill the safety functions 12
required of them. Where control measures on operator actions are called on to maintain 13
safety, an initial safety assessment plan has to be carried out to demonstrate that the 14
arrangements made are robust and that they can be relied on. 15
16
The safety assessment plan shall include, as appropriate, a systematic critical review of: 17
18
1. The operational limits and conditions for the operation of the facility. 19
2. The ways in which structures, systems and components, including software, and 20
procedures relating to protection and safety might fail, singly or in combination, or 21
might otherwise give rise to exposures and the consequences of such events; 22
3. The ways in which external factors could affect protection and safety. 23
4. The ways in which operating procedures relating to protection and safety might be 24
erroneous, and the consequences of such events. 25
26
A. SAFETY ASSESSMENT PLAN FOR INITIAL FACILITIES 27
28
I. Name and location of the facility: (Provide a detailed location of the facility) 29
30
II. Layout of the facility: 31
32
Describe factors such as the layout of the facility and its immediate 33
surroundings, building materials, shielding. 34
Provide sketch or drawing of the above conditions reflecting the actual 35
room size, x-ray machine placement, control console, darkroom, waiting 36
area, interpretation room, and other adjacent areas to the x-ray room. 37
Delineate controlled and supervised areas. 38
39
III. Type of x-ray equipment: (General Radiography, Radiographic/Fluoroscopic, 40
Computed Tomography, Mammography, etc.) 41
42
Provide detailed condition and specification of the x-ray equipment (brand 43
new, reconditioned, refurbished, modified, etc.) 44
Provide acceptance testing and commissioning report for the x-ray 45
machine/s. 46
Page 45 of 17
IV. Safety assessment plan of the facility 1
2
Installation of grounding for the x-ray equipment, electrical and 3
mechanical safety checks. 4
Measurements for the x-ray room shielding, protective barrier, and 5
adjacent areas. 6
Warning signs and notices. 7
8
V. Inventory of Personal Protective Equipment (PPE): 9
Presence of lead apron, lead gloves, contact gonad shields, upright gonad 10
shields, etc. and other applicable PPEs 11
Safety assessment plan procedure for the above PPE 12
Subscription of Personal Monitoring Devices 13
14
VI. Notarized Certificate that the above requirements are complete and totally 15
verified by the owner/licensee 16
17
VII. Proposed date of operation: ________________________________________ 18
19
VIII. Name, signature and contact details of the authorized representative of the 20
authorized officer (Medical Radiation Practitioner Or Radiation Protection 21
Officer) 22
23
B. SAFETY ASSESSMENT PLAN FOR RENEWAL FACILITIES 24
25
I. Name and location of the facility: (Provide an updated detailed location of the 26
facility) 27
28
II. Layout of the facility: 29
30
Describe factors such as the layout of the facility and its immediate 31
surroundings, building materials, shielding. 32
Provide sketch or drawing of the above conditions reflecting the actual 33
room size, x-ray machine placement, control console, darkroom, waiting 34
area, interpretation room, and other adjacent areas to the x-ray room. 35
Delineate controlled and supervised areas. 36
37
III. Type of x-ray equipment: (General Radiography, Radiographic/Fluoroscopic, 38
Computed Tomography, Mammography, etc.) 39
40
Provide preventive maintenance reports and records pertaining to the 41
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IV. Safety assessment plan of the facility 1
2
Provide workplace monitoring reports including the measurement points, 3
frequency of monitoring 4
5
V. Inventory of Personal Protective Equipment (PPE): 6
Presence of lead apron, lead gloves, contact gonad shields, upright gonad 7
shields, etc. 8
Preventive maintenance reports of the above PPEs 9
Keep updated dose evaluation reports and describe policy for reviewing the 10
occupation doses and the actions to be taken when dose limits are exceeded 11
12
VI. Notarized Certificate that the above requirements are complete and totally 13
verified by the owner/licensee 14
15
VII. Name, signature and contact details of the authorized representative of the 16
authorized officer (Medical Radiation Practitioner Or Radiation Protection 17
Officer) 18
19
Note: Complete information is expected from the facility as to the actual operation. The 20
FDA may require additional information to fully consider this application prior to issuance 21
of authorization. 22
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APPENDIX L 1
List of Acronyms and Abbreviations 2
3
AEC – Automatic Exposure Control 4 AO-Administrative Order 5 COC- Certificate of Compliance 6 COL – Coefficient of Linearity 7 COV – Coefficient of Variation 8
CQMP-Clinically Qualified Medical Physicist 9 CT – Computed Tomography 10 DICOM – Digital Imaging and Communication in Medicine 11
DIRMP-Diagnostic and Interventional Radiology Medical Physicist 12 DPBR –Diplomate, Philippine Board of Radiology 13 FCM – Facility compliance Monitoring 14 FDA-Food and Drug Administration 15 FPCR – Fellow, Philippine College of Radiology 16
FPHA –Fellow, Philippine Heart Association 17 FPROS – Fellow, Philippine Radiation Oncology Society 18 IBSS – International Basic Safety Standards 19
IEC- International Electrotechnical Commission 20 ISO – International Organization for Standardization 21 LTO-License to Operate 22
MPV – Mean Pixel Value 23
PAB – Philippine Accreditation Bureau 24 PACS – Picture Archiving and Communication System 25 PBR – Philippine Board of Radiology 26
PCR – Philippine college of Radiology 27 PNS – Philippine National Standards 28
PSCCI – Philippine Society of Cardiac Catheterization Interventionalists 29 PSVIR – Philippine Society of Vascular and Interventional Radiology 30 QA/QC – Quality Assurance/Quality Control 31 QAP – Quality Assurance Program 32
RIS – Radiology Information System 33 RPO – Radiation Protection Officer 34 RPP – Radiation Protection Program 35
RPSE – Radiation Protection Survey and Evaluation 36
SID – Source to Image Distance 37 38
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