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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: [email protected]

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

http://www.doh.gov.ph/

mailto:[email protected]

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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

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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

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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

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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

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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

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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,

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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

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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

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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

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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

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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

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

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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

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

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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

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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)



Level 1 – Level 3 Diplomate of the Philippine




in good standing

Non- radiologist physicians

doing image guided

fluoroscopic procedures

(orthopedic surgeons,

internists, urologists,

nephrologists and obstetric-

gynecologists)



Specialized Interventional Radiology:

Fellow of the Philippine

Society of Vascular and

Interventional Radiology

(PSVIR)


Heart Association (FPHA)

with specialization in

interventional cardiology


Society of Cardiac

Catheterization

Interventionalists (PSCCI)

PHA and PSCCI: With

additional training in

Radiation Protection in

Interventional Radiology

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Mammography:

Diplomate of the Philippine




in good standing

Computed Tomography:

Diplomate of the Philippine




in good standing.

Fellow, CT-MRI Society of

the Philippines

Bone Densitometry:

Member, Osteoporosis

Society of the Philippines.

Member, Philippine Society

of Nuclear Medicine



Lithotripsy:

Member, Philippine

Urological Association



Tumor Localization and

Simulation:

DPBR/FPCR

DPBR-RO

FPROS

1

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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

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

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

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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

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

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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

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

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

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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

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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

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

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

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

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 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

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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.

of 17

-Check for the output

reproducibility

-AEC Performance Assessment

-Image Quality Evaluation

-Measurement of Average

Glandular Dose


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

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

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

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

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

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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

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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

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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

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

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

42

43

44

45

of 17

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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