Quality Assurance in

Diagnostic Radiology
&
AERB
SUMALI SINGH
1618556
QUALITY ASSURANCE IN
DIAGNOSTIC
RADIOLOGY
 OUTLINE

 Definition
 Aim of Quality Assurance
 Why QA in diagnostic Radiology ?
 Radiology department QA program
 What is QA Program ?
 Objective of QA Program
 Quality Assurance Committee
 Conclusion
 DEFINITION
Quality Assurance means the planned and
systematic actions that provide adequate
confidence that a diagnostic x-ray facility will
produce consistently high quality images with
minimum exposure of the patients.
AIM of Quality Assurance
Optimum image quality of radiological
procedures with minimum possible dose to
the patient
 Why QA in diagnostic Radiology ?
 To get calibrate all the exposure parameters, to
check functional performance of X-ray equipment
& radiation safety around the X-ray installation, QA
checks are necessary for every diagnostic X-ray
equipment
 In other words, to obtain the optimum quality
diagnostic information at the lowest radiation risk
to the patient, QA of diagnosis X-ray equipment is
necessary
 Radiology department QA program

 A documented QA program should be developed,

under the guidance of the QAC, specifically to
address the needs of the radiology department.

 The QA program should clearly define the goals

and objectives of the department.

 It should cover both QC testing techniques and

administrative procedures.
What is Quality Assurance program ?

An organized effort by the staff operating a facility to

ensure that the diagnostic images produced are of a
sufficiently high quality so that they consistently
provide adequate diagnostic information at the lowest
possible cost and with the least possible exposure of the
radiation to patient.
 OBJECTIVE OF QA PROGRAM
 The primary goal of QA program is to ensure the
accurate diagnosis of patients

 To maintain the quality of diagnostic images

 To minimize the radiation exposure to patient and

staff

 To be cost effective
 The QA program includes
 Periodic quality control tests
 Administrative methods
 Preventive maintenance procedures
 Training
1. Quality control test
 It is an integral part of Quality assurance.

 It involves specific actions designed to keep

measurable aspects of the process involved in
manufacturing a product (image) or providing a
service within specified limits.
QC is summarized in 4 principal steps:

1. Acceptance testing to detect in equipment that is

newly installed or has undergone major repair.
2. Establishment of baseline performance of the
equipment.
3. Detection and diagnosis of changes in equipment
performance before they become apparent in images.
4. Verification that the causes of deterioration in
equipment performance have been control.
 Frequency
 Frequency of QC tests is different for different
systems

 The frequency of tests may need to be increased

depending on many factors including the age and
stability of the x-ray equipment and film processing
equipment, as well as the number of problems being
encountered
2. Administrative Methods
 These procedures are design to verify that QC testing
is effective, i.e., the tests are performed regularly and
correctly, the results evaluated promptly and
accurately, and the necessary action taken.

 They include recommendations regarding the

responsibility for quality assurance action, staff
training, equipment standards, and the selection of the
appropriate equipment for each examination.
3. Preventive Maintenance
Procedure
These are performed on a regularly scheduled basis
with the goal of preventing breakdowns due to
equipment failing without signs detectable by
monitoring.
These procedures include:

 Visual inspection of mechanical and electrical

characteristics of x-ray system
 Assuring cleanliness with respect to spilling of
contaminants on examination room
 Following the manufacturer's recommended
procedures for cleaning and maintenance of the
equipment.
 Regular inspection and replacement of switches and
parts that routinely wear out or fail.
 4. Training
 The QA program include the means to provide
appropriate training for all personnel with QA
responsibilities to ensure each meet a minimum level
of competency to perform test correctly and
consistently
 Adequate training of personnel will ensure that the
tests are performed correctly and consistently.
 The facility must ensure that there are sufficient
trained personnel so that there is always someone
available (i.e. to cover vacation and sick time) to
perform the necessary testing.
QUALITY ASSURANCE COMMITTEE

 Quality Assurance Committees (QACs) are

committees established for the purpose of improving
the safety and quality of health services.

 They have an overall documented strategy with

clearly defined work plans to achieve the goals and
objectives of the radiology department
QA committee members include:
 Medical Physicist
 Radiologist
 Biomedical engineer
 Medical Imaging Technologist and
Radiographer
 Information Technology technician
 CONCLUSION
 QA promote the effective use of radiation for a diagnostic
outcome through achieving and maintaining image quality
and reduction of patient dose.

 An established QA program monitor the imaging process

from start to finish and reveal potential problems that may
otherwise go unrecognized, through a sequence of QC tests.

 QA in medical imaging is a rapidly evolving concept and

each facility is encouraged to continually pursue ways to
improve and expand its program.
 AERB
(Atomic Energy
Regulatory Board)
 OUTLINE

What is AERB ?
History
Aim of AERB
Function
Regional Regulation Centre
AERB Regulatory Board Process
Rules & Protocols of AERB
Regulatory requirements for diagnostic radiology facilities
e-LORA
Aim of e-LORA
What is AERB ?
AERB is stands for Atomic Energy Regulatory Board.

It carries out certain regulatory and safety functions

under the Atomic Energy Act,1962 and Environment
Protection Act,1986.

The Headquarter is in MUMBAI.

Chairman – Abhilash Bhardwaj

HISTORY
The Atomic Energy Regulatory Board (AERB) was
constituted on 15 November 1983 by the President
of India by exercising the powers conferred by
Section 27 of the Atomic Energy Act,1962.
 AIM OF AERB
The aim of the AERB is to ensure the use of
ionizing radiation and nuclear energy in India
does not cause undue risk to the health of people
and the environment.
 FUNCTIONS OF AERB
 Develop safety policies in nuclear radiation and
industrial safety areas.

 Promote research and development efforts in the areas of

safety.

 Prescribe the acceptance limits of radiation exposure to

occupational workers and members of the public and
acceptable limits of environmental release of radioactive
substance.
 Develop safety codes, guides and standards for siting,
design, construction, commissioning, operation and
decommissioning of different types of nuclear and
radiation facilities.

 Grant consent for siting, design, construction,

commissioning, operation and decommissioning after an
appropriate safety review and assessment foe
establishment of nuclear and radiation facilities.

 Maintain liaison with statutory bodies in the country as

well as aboard regarding safety matters.
 Review the nuclear and industrial safety aspects in
nuclear facilities.

 Review the training program, qualifications and

licensing policies for personnel of nuclear and radiation
facilities and prescribe the syllabi for training of
personnel in safety aspect at all levels.

 Review the emergency preparedness plans for nuclear

and radiation facilities.
 REGIONAL REGULATORY CENTRE

Regional regulatory centre are :

 Eastern region: regulatory centre in Kolkata

 Northern region: regulatory centre in New Delhi

 Southern region: regulatory centre in Chennai

Responsibilities of these centers are

Regulatory inspection of nuclear and radiation facilities

in the respective special and surprise inspection.

Reviews related to consenting process of radiation

facilities and the excessive exposure areas cases in the
radiation facilities in respective regions.
AERB REGULATORY BOARD PROCESS

Regulated by five main divisions:

1. Document development
2. Safety review and assessment
3. Licensing/Consenting
4. Regulatory inspection
5. Regulatory enforcement
1. Document development
 AERB develops and lays down safety requirements and
guidance for utilities and users in form of Regulatory
Safety Documents.
 Regulatory Safety Documents are developed with a
view to cover entire spectrum of regulated nuclear and
radiation facilities and activities
 Regulatory Safety Documents are categorized as:
1. Safety codes and standards
2. Safety guidelines
3. Safety manuals and guides
2. Safety review and assessment
The safety review
 Ensure adherence to provinces of rules, safety
requirements, license conditions and other
requirements of AERB
 Review by staff of AERB

The safety review & assessment include

 Grant of license
 Enforcement action like revocation or
suspension of license.
3. License/Consenting
The regulatory consent is the global word for license,
authorization, certification, registration, approval.

Consent mainly issued for nuclear and radiation facilities

for e.g.,
 X ray units
 CT units
 Nuclear medicine
 Industrial radiography
4. Regulatory inspection
 It ensures that the nuclear/radiation facility is in
compliance with legal and regulatory requirements
and licensing conditions.
 AERB conducts routine inspections periodically to cover
all the activities of the license.
 Also conduct special inspections and unannounced
inspections to obtain firsthand and realistic
information.
5. Regulatory enforcement

 AERB has powers to take enforcement actions to

administer the provisions of rules made under Atomic
energy act 1962 for ensuring radiological safety as
well as industrial safety.
 Provision rule-31 include power to investigate, seal
and radiation installation
 Provision rule-35 include offences and penalties.
Rules & Protocols of AERB for Radiation
Protection
• License: No installation for siting, design, construction,
layout without any license.

• Issuance of license: Issued after 120 days of the

submission of the form on e-LORA website.

• Fees of license: with respect to the radiation practice

and department usage.
• Health surveillance of workers and employers

• Safety standard, codes and guidelines

• Assigning RSO

• Prohibition of employment of person below certain

age.

• Radiation monitoring
 Regulatory requirements for diagnostic radiology facilities

 Procurement of X-ray equipment

 Operation of X-ray equipment
 Pre-requisites for obtaining license for operation of X-
ray equipment
 Vehicle mounted X-ray equipment
 Staffing Requirements
 Radiological safety officer
 Radiation protection devices
 Personnel monitoring device
 Quality assurance requirements
 Servicing
 Periodic safety reports
 Renewal of license
 Decommissioning of X-ray requirement
 e-LORA
 e-LORA stands for e-licensing of radiation
application

 e-LORA is an e governance initiative by AERB, is a

web base application for automation of regulatory
processes for various radiation facilities in India.
AIM of e-LORA
To enhance the efficiency and transparency in
regulatory process of AERB.

It aims to achieving paperless licensing of radiation

facility.
THANK
YOU