MIS Draft Standard PDF

FOREWORD
Radiology covers the medical imaging of patient to provide information for the diagnosis,
prevention and treatment of disease. In recent decades medical imaging has experienced a
technological revolution. Clinical advantages of these services are enormous and affect
critical decision making at every stage of patient management. However they could represent
unnecessary cost to health care systems in the country if the quality provided is less than
optimal. Hence to assess the quality and safety of medical imaging services and to represent
a method for monitoring of quality standards, basic accreditation programme needs to be
implemented in the country for medical imaging services. These standards reflect the
expectations of good imaging radiology services from the view of point of providers as well as
that of primary (patient) and secondary client (referrer).
National accreditation committee for medical imaging services establishes and maintain
accreditation standards for diagnostic imaging services with main goal to improve diagnostic
accuracy and safety. These standards along with standards for calibration of testing
laboratories by NABL are applicable to all diagnostic centres.
These standards are product of rigorous one year development process during which they
have been through a number of iterations. The current standards reflect the professional
judgement of the expert panels of radiologist and medical imaging services providers who
have seen the creation and revision of this document. The standards have been externally
evaluated by the panel of Radiologists as well as been subjected to a full public consultation
exercise prior to their finalisation. The process of formulating these standards is evolutionary
and dynamic, and shall be kept updated as required.
NABH accreditation for medical imaging services is applicable to all organisations providing
clinical radiological imaging including both private and public sector organisation.
TABLE OF CONTENTS
Sl.
Particulars
1.
Introduction to Medical Imaging Services
2.
Standards
3.
Scope of Services
Section 1
6-33
4.
Control of Services (CS)
10-12
5.
Control of Processes and Procedures (CPP)
13-15
6.
Control of Facility and Environment (CFE)
16-18
7.
Control of Personnel (CP)
19-21
8.
Control of Equipment (CE)
22-24
9.
Control of Documents and Record (CDR)
25-28
10.
Risk control and Safety (RCS)
29-33
Section 2
34-82
11.
Control of Services (CS)
35-39
12.
Control of Processes and Procedures (CPP)
40-43
13.
Control of Facility and Environment (CFE)
44-48
14.
Control of Personnel (CP)
49-56
15.
Control of Equipment (CE)
57-64
16.
Control of Documents and Record (CDR)
65-72
17.
Risk control and Safety (RCS)
72-84
Section 3
Page No.
INTRODUCTION TO MEDICAL
IMAGING SERVICES
Medical Imaging Services cover investigations of patients that provide imaging information for
diagnosis, prevention, and treatment of disease; or assessment of health. It includes
conventional radiation based diagnostic radiology as well as a wide variety of specialised
techniques including ultrasound, Doppler, Bone densitometry, CT scan, MRI, PET-CT etc.
These services are essential for patient care and therefore must meet the needs of all patient
and the clinical personnel responsible for the care of those patients. These services include
arrangement for requisition, choice of correct (most informative and cost effective) imaging
techniques, patient information, patient consent, patient preparation, patient identification,
performance of imaging procedures, interpretation, reporting and advice regarding the result,
in addition to the consideration of safety and ethics in diagnostic imaging services.
A medical imaging centre must maintain certain standard of services (statutory or otherwise);
as well as, strive for continuous improvement in the quality of services they provide.
Close collaboration with clinical colleagues, verification of result and correct maintenance and
calibration of the equipment are also a part of quality management in the department of
medical imaging.
Standards for NABH Accreditation for medical imaging services are thus developed and
formulated, they are divided into 7 chapters containing 27 standards and 113 objective
elements. These standards provide general guidelines pertaining to all diagnostic imaging
services. Specific guidelines for X-ray, Fluoroscopy, USG, CT scan, MR and Nuclear Imaging
etc. are then provided separately in the same chapter for completeness of the document
# There are certain tests routinely performed in diagnostic centres e.g. ECG, EEG, EMG, Nerve
conduction etc., but as they are not imaging methods and are performed & reported by technical
medical specialist other than radiologists, they are not included in these standards
STANDARDS
For convenience, the standards are grouped into seven chapters as follows:
CHAPTER 1 Control of Services
CHAPTER 2 Control of Processes and Procedures
CHAPTER 3 Control of Facility and Environment
CHAPTER 4 Control of Personnel
CHAPTER 5 Control of Equipment
CHAPTER 6 Control of Documents and Record
CHAPTER 7 Risk control and safety
Section one comprises the standard statement and objective elements.
Each standard statement addresses one aspect necessary for the provision of the service.
A list of objective elements under each standard indicate the structures and processes
necessary to deliver the standard statement where term MIS refers to Medical Imaging
Services.
Section two comprises a brief details why that standard statement is considered to be
important and guidelines to explain the objective element is provided thereafter.
Medical Imaging Services (MIS) participating in accreditation will be expected to provide
three types of evidence.
Approved documents that identify relevant service policy, protocols and/or strategies and
set out how the service plans to deliver each standard statement and objective element
therein.
Evidence that demonstrate that the Medical Imaging service is implementing these
policies, protocols and/or strategies.
Evidence that demonstrates that the service is monitoring its performance regularly
(frequency of monitoring and any targets are set by the service) in the implementation of
its policies, protocols and strategies.
Section three comprises of Annexure

Annexure 1 Legal requirements
Annexure 2 REGULATION & CERTIFICATION FOR MEDICAL X-RAY (chapter-4)
Annexure 3 Glossary
SCOPE OF SERVICES
Radiology
General Radiology
Dental Radiology
Computerised Radiography
Digital Radiography
Fluoroscopy Guided investigative procedure/
Interventional Procedures
Angiography/ Cath Labs setups for vascular
imaging/ interventional procedures
Mammography
Diagnostic Mammography
Screening Mammography
Interventional Procedure
Ultrasound
General Ultrasound
Colour Doppler flow imaging
Interventional procedures
for diagnosis
for therapy
Bone mineral Densitometry
Dual Energy X Ray Absorptiometry (DEXA)

Quantitative Computed Tomography (QCT)
Quantitative Ultrasound(QUS)
Magnetic Resonance Imaging

(MRI)
Computed Tomography
(CT) scan
Nuclear Medicine
General Nuclear Medicine

Positron Emission Tomography(PET)/PET-CT
SPECT
Miscellaneous
Radio frequency ablation(RFA)

Picture
archiving
and
system(PACS)
Tele radiology
communication
Section-1
CHAPTERS
Chapter 1
(CS) Control of Services
a.
Medical Imaging Service ensures delivery of the service from point of referral to
discharge.
b.
Medical Imaging Service ensures that the delivery of services is patient focused.
Chapter 2
(CPP) Control of Processes and Procedures
a.
Medical Imaging Service ensures the acquisition of optimal diagnostic quality images
and performance of diagnostic procedures.
b.
Medical Imaging service ensures the quality (clinical and technical) of reports
c.
Medical Imaging service ensures quality of interventional procedures
d.
Medical Imaging service ensures proper management of drugs and contrast media.
Chapter 3
(CFE) Control of Facility and Environment
a.
Medical Imaging service ensures proper management of facility
b.
Medical Imaging service ensures proper management of environment of the facility.
Chapter 4
(CP) Control of Personnel
a.
Medical Imaging service ensures authorization, management and support to staff to

deliver the service.
b.
Medical Imaging Service ensures that the staff is competent to deliver the service
assigned to them.
c.
Medical Imaging Service ensures service and workforce review, planning and
development.
Chapter 5
(CE) Control of Equipment
a.
Medical Imaging Service ensures appropriate procurement and installation of the

equipments.
b.
Medical Imaging Service ensures appropriate operation and working of the

equipments.
c.
Medical Imaging Service ensures appropriate maintenance and repair of the

equipments.
d.
Medical Imaging Service ensures appropriate replacement of existing equipment &

planning for new equipment for continuation and expansion of service.
Chapter 6
(CDR) Control of Documents and Record
a.
Medical Imaging Service ensures generation, completion, revision, retention and

dissemination of information documents for staff, patients and others.
b.
Medical Imaging Service ensures procurement and maintenance of documents of

legislative and statutory requirements related to facility, equipment and risk
monitoring.
c.
Medical Imaging Services ensures maintenance and updating of personnel data

records of all staff.
d.
Medical Imaging Services ensures maintenance and updating of all equipment

related records pertaining to their purchase, operation, maintenance and disuse.
e.
Medical Imaging Services ensures maintenance of medical imaging reports and

records of all the patients.
f.
Medical Imaging Services ensures maintenance and updating of all records and
documents pertaining to audit, quality control & quality improvement of all processes
and services.
g.
Medical Imaging Services ensures maintenance, integration, safety, confidentiality

and retrievability of all the records.
Chapter 7
(RCS) Risk control and safety
a.
Medical Imaging Services ensure that the risk associated with imaging procedures
are identified, assessed, managed and minimised.
b.
Medical Imaging Service ensures that the risk of infection to staff, patient and others
is identified, assessed, managed and minimised.
c.
Medical Imaging Service ensures that the risk associated with hazardous
substances and materials to staff, patient and others are identified, assessed,
managed and minimised.
d.
Medical Imaging Service ensures that the risk of violence and aggression to staff,
patient and others are identified, assessed, managed and minimised.
e.
Medical Imaging Service ensures that the risk associated with fire, electrocution and
other disaster to staff, patient and others and to facility and environment are
identified, assessed, managed and minimised.
CHAPTER 1
a.
Medical Imaging Services shall address systems to ensure delivery of the

service from point of referral to discharge.
b.
Medical Imaging service shall ensure that the delivery of services is patient
focused.
10
CHAPTER 1
Standard
a.
Medical Imaging service shall address systems to ensure delivery of the

Objective elements
a.
Roles and responsibilities of each area of service delivery are defined.
b.
MIS ensures that protocols for imaging pathways and processes are specified,
implemented and monitored
c.
Time frame to manage imaging pathways from referral to discharge from the MIS is
defined, implemented and monitored.
d.
MIS ensure justification, scheduling and prioritisation of referrals according to patient

conditions and urgency of diagnosis.
e.
MIS ensure that alternative imaging pathways are offered if considered in

accordance with radiation risk or emerging newer clinical practices in collaboration
with the referrer.
Standard
CS 2
Medical Imaging service ensures that delivery of services is patientfocused.
Objective elements
a.
The roles and responsibilities for staff managing each area of service to the patient
(information, delivering of service and care, safety, privacy) are defined
b.
MIS ensure that the information about specific examination/procedure is available to

patients and attendant in relevant format and language.
c.
MIS ensure that informed consent is obtained from the patient/carer by designated
staff in relevant format and language.
11
d.
MIS ensure safety of patients, carer and their belongings while in the facility.
e.
MIS ensure safe transport of the patients within, to and from the facility whenever
required.
f.
MIS ensure privacy and dignity of the patient without any discrimination.
g.
MIS ensure continuity of care of patients in collaboration with the referrer.
(The imaging information shall be collated with relevant clinical laboratory and previous
imaging details to be provide complete and comprehensive information about the patient
condition)
h.
12
MIS ensure that patient feedback are obtained, collated, analysed and used as guide
to future improvement in service delivery system.
CHAPTER 2
a.
Medical Imaging service ensures the acquisition of optimal diagnostic

quality images and performance of diagnostic procedures.
b.
Medical Imaging service ensure the quality (clinical and technical) of

reports
c.
Medical Imaging service ensures quality of interventional procedures
d.
Medical Imaging service shall ensures proper management of drugs and

contrast media
13
CHAPTER 2
Standard
CPP 1 Medical Imaging service ensures the acquisition of optimal diagnostic
Objective elements
a.
Roles and responsibilities of staff for management of each area of image acquisition
and image quality are defined in accordance with their training & experience
b.
MIS ensure that protocols for image acquisition for all examination are developed,
communicated, implemented and monitored
c.
MIS assure quality of diagnostic images
Standard
CPP 2 Medical Imaging service ensure the quality of reports (clinical and
technical)
Objective elements
a.
Roles and responsibilities for staff who report images are defined in accordance with
their training & experience
b.
MIS ensure that the structure, content and format of reports are consistent as
developed and communicated to the relevant staff.
c.
MIS assure the quality, accuracy and verification of reports and amendments
within specified timescale
d.
MIS ensure communication of reports to primary and secondary clients within

specified timescale.
14
Standard
CPP 3 Medical Imaging service ensures quality of interventional procedures
Objective elements
a.
Roles and responsibilities for staff who conduct interventional procedures are defined
in accordance with their training & experience.
b.
MIS ensure that risk related to interventional procedures to staff, patient and others
are defined assessed and managed according to emerging clinical practices
c.
MIS ensure that protocols for all interventional procedures are developed,
maintained, communicated, implemented and monitored
d.
MIS ensure that appropriate clinical and emergency support is available before,
during and after the procedure.
e.
MIS ensures that the quality and outcomes of interventional procedures are as per
standard benchmarks and continuously strives to improve the same
Standard
CPP 4 Medical Imaging Medical Imaging service ensures proper management
of drugs and contrast media
Objective elements
a.
Roles and responsibility for the staff in the area of drug and contrast media are
defined in accordance with their training & experience
b.
MIS ensure that protocols for prescription, purchase, storage, supply, handling,
labeling & administration of drugs and contrast media are defined, communicated,
implemented and monitored.
c.
MIS ensure coordination between relevant teams/departments/organizations

regarding the administration of drugs and contrast media to the patients and
corrective action taken in case of adverse drug/contrast reaction.
d.
MIS ensure that patients at higher risk of adverse reactions to specific drugs and
contrast media are defined and accordingly managed.
15
CHAPTER 3
(CFE) Control of facility and environment
a.
Medical Imaging service ensures proper management of facility.
b.
Medical Imaging service ensures proper management of environment of

the facility.
16
Chapter 3
(CFE) Control of facility and environment
Standard
CFE 1 Medical Imaging service ensures proper management of facility.
Objective elements
a.
The roles and responsibilities of management of each area of facility are defined
b.
MIS ensures proper and adequate signage to guide the patient and attendant to and
within the facility.
c.
MIS ensure that design and construction of the facility shall be in accordance with
the legal requirements pertaining to the equipment and the services offered.
d.
MIS ensures that design and construction of the facility supports specific needs of the
patient population (including children and those with particular needs) and staff
e.
MIS ensures the management of space to facilitate efficient working, comfort, safety
and hygiene.
f.
MIS ensures that all the areas used by service are well-maintained in respect to
hygiene, cleanliness, ventilation, water & electricity supply, sewage & waste
disposal.
g.
MIS ensures that the access to particular areas is restricted according to specific
needs and risks with proper barrier and signages.
Standard
CFE 2 Medical Imaging service ensures proper management of environment of
the facility.
Objective elements
a.
MIS ensures that the protocols to assess and manage specific risks related to
internal and external incident are defined, communicated, implemented and
monitored.
b.
MIS ensures that the facility is designed to minimize the risk of injury and occupational
illness
17
c.
18
MIS ensures that the facility has process to monitor, control and record
environmental conditions as require by relevant specification or where they may
influence the procedure and quality of the results.
CHAPTER 4
a.
Medical Imaging service ensures authorization, management and

support to staff to deliver the service.
b.
Medical Imaging service ensures that the staff is competent to deliver

the service assigned to them.
c.
Medical Imaging service ensures service and workforce review,

planning and development.
19
Chapter 4
Standard
CP 1
Medical Imaging service ensures authorization, management and

Objective elements
a.
Roles and responsibility of staff to deliver the service are defined, communicated
and consistently applied
b.
MIS ensures that the appropriate skill mix and staff complement exist for specific
areas of task
c.
MIS ensures that agreed contracts of employment, job descriptions and/or job plans,
and that appraisals or personal development reviews are conducted for all staff
d.
MIS ensures that employment policies and procedures and any changes to the
service are communicated and consistently applied within defined time frame.
e.
MIS ensures management of the staff service provision and working hours
f.
MIS ensures to support staff in managing stress, conflicts and grievance in a fair &
judicious manner
g.
MIS ensures that staff are able to comment/feedback in confidence regarding

service and considered while planning future changes in improving quality of
services
Standard
CP 2
Medical Imaging service ensures that the staff are competent to deliver
the service assigned to them
Objective elements
a.
Roles and responsibilities for the management of staff competence are defined
b.
MIS ensures that policies and procedures for selection and recruitment of staff are
20
c.
MIS ensures that record and check of qualification, training, experiences and
registration status of staff is maintained.
d.
MIS ensures that all the staff are supported to maintain necessary skills knowledge
and levels of competence and are encouraged to develop new skills.
Standard
CP 3

Objective elements
a.
MIS ensures that roles and responsibilities for each area of review, planning and
improvement, and workforce planning and development are defined
b.
MIS ensures involvement of feedback & comments from patients, staff, users and
others are encouraged by the management while reviewing and planning service
and development.
c.
MIS ensures that workforce development initiatives are defined, communicated and
evaluated
d.
MIS ensures the timing frequency content and delivery of relevant education and
training to the staff.
e.
MIS ensures that policies pertaining to the service review to support and monitor
staff retention and succession planning are defined.
f.
MIS ensures effective and fair management of grievance and complaints from
patients by competent and authorised staff.
21
CHAPTER 5
a.
Medical Imaging service manages and monitors appropriate

procurement and installation of the equipments to deliver the service.
b.
Medical Imaging service manages and monitors appropriate operation

and working of the equipments to deliver the service.
c.

maintenance and repair of the equipment to deliver the service.
d.

replacement of existing equipment & planning for new equipment for
continuation and expansion of service.
22
Chapter 5
Standard
CE 1
Medical Imaging service ensures

installation of the equipments.
appropriate
procurement
and
Objective elements
a.
Roles and responsibilities for each area of the procurement and management of all
equipments are defined
b.
MIS ensures that the policies and protocols for the procurement of all equipment and
consumables are defined, implemented and monitored
c.
MIS ensures that the installation of equipments are defined, implemented and
monitored.
Standard
CE 2
Medical Imaging service ensures appropriate operation and working of

the equipments.
Objective elements
a.
Roles and responsibilities for each area of the operation and working of all
equipments are defined.
b.
MIS ensures that operation of equipments are defined, implemented and monitored.
c.
MIS ensures that calibration, operation and performance of equipment are defined,
d.
MIS ensures that proper record of calibration of the equipments are maintained.
23
Standard
CE 3
Medical Imaging service ensures appropriate maintenance and repair of

the equipment to deliver the service.
Objective elements
a.
MIS that the roles and responsibilities for maintenance and repair of the equipment
are defined.
b.
MIS ensures that maintenance and service contracts of all equipment are drawn and
kept updated.
c.
MIS ensures that equipment failures and faults are monitored and managed and that
safety warnings, alerts and recalls are circulated and acted upon within specified
timescales
d.
MIS ensures that records pertaining to maintenance and repair of equipment are
maintained according to preset guidelines/protocols.
Standard
CE 4
Medical Imaging service ensures appropriate replacement of existing

equipment & planning for new equipment for continuation and
expansion of service.
Objective elements
a.
MIS ensures that roles and responsibilities for replacement of existing equipment &
planning for new equipment for expansion of service are defined.
b.
MIS ensures that equipment replacement and/or up gradation is planned and

implemented in accordance with finance manager and workforce manager /
Appropriate authority.
24
Chapter 6
a.
Medical Imaging Services ensures generation, completion, revision,

retention and dissemination of information documents for staff, patients
and others.
b.
Medical Imaging Services ensures procurement and maintenance of

documents of legislative and statutory requirements related to facility,
equipment and risk monitoring.
c.
Medical Imaging Services ensures maintenance and updating of

personnel data records of all staff.
d.
Medical Imaging Services ensures maintenance and updating of all the

equipment related records pertaining to their purchase, operation,
maintenance and disuse.
e.
Medical Imaging Services ensures maintenance of personal, imaging

and reports records of all the patients.
f.
Medical Imaging Services ensures maintenance and updating of all the

records and documents pertaining to audit, quality control & quality
improvement of all processes and services.
g.
Medical Imaging Services ensures maintenance, integration, safety,

confidentiality and retrievability of all the records.
25
Chapter 6
Standard
CDR 1 Medical Imaging Services ensures generation, completion, revision,
and others.
Objective elements
a.
Roles and responsibilities for generation, completion, revision, retention and

dissemination of patient information data in designated format and language are
defined.
b.
Roles and responsibilities for generation, completion, revision, retention and

dissemination of staff information & instruction data in designated format and
language are defined.
c.
MIS ensures that the protocols and procedures for inclusion of feedback from staff,
patient and others for revision and up gradation of information data are maintained
and implemented
Standard
CDR 2 Medical Imaging Services ensures procurement and maintenance of
documents of legislative/Regulatory and statutory requirements related
to facility, equipment and risk monitoring.
Objective elements
a.
MIS ensures that document related to all the legislative and statutory requirements
related to facility, equipment and risk monitoring are maintained.
Standard
CDR 3 Medical Imaging Services ensures maintenance and updating of
personnel data records of all staff.
Objective elements
a.
26
MIS ensures that personnel data records of all staff are maintained and periodically
updated.
Standard
CDR 4 Medical Imaging Services ensures maintenance and updating of all
equipment related records pertaining to their purchase, operation,
maintenance and disuse.
Objective elements
a.
MIS ensures that all the records pertaining to purchase, operation, maintenance and
disuse of equipment are maintained.
Standard
CDR 5 Medical Imaging Services ensures maintenance of medical imaging and
reports records of all the patients.
Objective elements
a.
Roles and responsibilities for maintenance of medical imaging and reports records of
all the patients are defined.
b.
MIS ensures that the protocols and procedures to define duration, format, content
and confidentiality of patients records are maintained and implemented.
Standard
CDR 6 Medical Imaging Services ensures maintenance and updating of all
records and documents pertaining to audit, quality control & quality
improvement of all processes and services.
Objective elements
a.
Roles and responsibilities for maintenance and updating of all records and
documents pertaining to audit, quality control & quality improvement of all processes
and services are defined.
b.
MIS ensures that the protocols and procedures for audit, quality check, verification
and validation are maintained and implemented.
c.
MIS ensures that the protocols and procedures for quality indicators, quality
assurance and quality improvements are defined.
27
Standard
CDR 7 Medical Imaging Services ensures maintenance, integration, safety,
confidentiality and retrievability of all the records
Objective elements
a.
Roles and responsibilities for maintenance, integration, safety, confidentiality and

retrievability of all the records are defined.
b.
MIS ensures that the protocols and procedures to identify, verify and classify records
and documents are defined, preferably in computerised format.
c.
MIS ensures that the protocols and procedures to define confidentiality and
retrievability of records are implemented and monitored.
28
Chapter 7
a.
Medical Imaging service ensures that the risk associated with imaging
procedures are identified, assessed, managed and minimised.
b.
Medical Imaging service ensures that the risk of infection to staff,

patient and others is identified, assessed, managed and minimised.
c.
Medical Imaging service ensures that the risk associated with

hazardous substances and materials to staff, patient and others are
d.
Medical Imaging service ensures that the risk of violence and

aggression to staff, patient and others are identified, assessed,
e.
Medical Imaging service ensures that the risk associated with fire,
electrocution and other disaster to staff, patient and others and to
facility and environment are identified, assessed, managed and
minimised.
29
Chapter 7
Standard
RCS1 Medical Imaging service ensures that the risk associated with imaging
Objective elements
a.
Roles & responsibilities for all level of risk management in all areas of imaging are
defined.
b.
MIS ensures that the radiation doses are as low as reasonably achievable for all
patients (ALARA principle) especially for children, women of child bearing age,
pregnant women, children and patients undergoing repeated exposures.
c.
MIS ensures that system in place to define, assess and manage risks of
occupational exposure to ionising radiation and record for the same is maintained.
d.
MIS ensures that facility, environment and equipment design and performance will
be kept in accordance with reduction of radiation risk to the minimum.
e.
MIS ensures that risks of acoustic output and exposure times are defined, assessed
and managed.
f.
MIS ensures minimum exposure to different types of electromagnetic fields,

radiofrequencies and any noise
g.
MIS ensures pre-entry safety checks for all patients, staff and others to minimise risk
associated with MRI imaging.
h.
MIS ensures that all the ancillary equipments used in MR examination area are
approved for MR environment.
i.
MIS ensures that the risk associated with use of ablative and therapeutic devices
during interventional procedures are defined, assessed and managed.
j.
MIS ensures that the incidents & errors pertaining to risks associated with imaging
procedures are reported, investigated, recorded, analysed, acted upon and used to
guide and plan the future action.
30
Standard
RCS2 Medical Imaging service ensures that the risk of infection to staff,
patient and others is identified, assessed, managed and minimised.
Objective elements
a.
The roles, responsibilities and accountabilities regarding infection control are

defined.
b.
MIS ensures that protocols and procedures to identify, assess, manage and
minimise the risk of infection to staff, patient and others are defined, implemented
and monitored.
c.
minimise the risk of infection to the patient with contagious & communicable disease
are defined, implemented and monitored.
d.
MIS ensures that the protocols and procedures for decontamination of equipment
and environment are defined, implemented and monitored.
e.
MIS ensures that the incidents & errors pertaining to risks of infection are reported,
investigated, recorded, analysed, acted upon and used to guide and plan the future
action.
Standard
RCS3 Medical Imaging service ensures that the risk associated with
Objective elements
a.
Roles, responsibilities and accountabilities for the control of hazardous substances

and materials are defined.
b.
minimise the risk associated with hazardous substances and materials to staff,
patient and others are defined, implemented and monitored.
c.
MIS ensures that the protocols and procedures to manage and dispose of waste are
defined, implemented and monitored.
d.
MIS ensures that appropriate protective equipment and equipments required to
31
decontaminate and manage exposure to hazardous substances are available and

maintained.
e.
MIS ensures that the incidents & errors pertaining to risks associated with hazardous
substances and materials are reported, investigated, recorded, analysed, acted upon
and used to guide and plan the future action.
Standard
RCS4 Medical Imaging service ensures that the risk of violence and
aggression to staff, patient and others are identified, assessed,
Objective elements
a.
Roles and responsibilities regarding risk of violence and aggression are defined.
b.
minimise the risk of violence and aggression to staff, patient and others are defined,
c.
MIS ensures that the protocols and procedures for support & counselling of patients,
staff and others who have been involved in an incident of violence and aggression
are defined, implemented and monitored.
d.
MIS ensures that the incidents & errors pertaining to risks of violence and aggression
are reported, investigated, recorded, analysed, acted upon and used to guide and
plan the future action.
Standard
RCS5 Medical Imaging service ensures that the risk associated with fire,
electrocution and other disaster to staff, patient and others and to
facility and environment are identified, assessed, managed and
minimised.
Objective elements
a.
Roles and responsibilities regarding risk associated with fire, electrocution and other
disaster are defined.
b.
minimise
32
c.
The risk associated with fire, electrocution and other disaster to staff, patient and
others are defined, implemented and monitored.
d.
MIS ensures that the protocols and procedures to define, access and manage
general health and safety risks are defined, implemented and monitored.
e.
MIS ensures that there are adequate safety equipments available and staff are
aware and trained in handling emergency/disaster.
f.
MIS ensures that the incidents & errors pertaining to risk associated with fire,
electrocution and other disaster are reported, investigated, recorded, analysed,
acted upon and used to guide and plan the future action.
33
Section 2
34
Chapter 1
CS 1
Medical Imaging service address systems to ensure delivery of the

Medical imaging services shall ensure following services for delivering of service from point of referral
to discharge:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Receiving the requisition/referral

Scheduling the examination
Reception, Registration and transport of patient
Patient information and consent regarding procedure, payment, report.
Patient identification
Patient preparation
Patient sedation if required
Performance of examination (protocols for imaging pathways and processes)
Patient care during and after procedure
Interpretation and reporting
Dispatch of report and advise regarding the result
Discharge of patient
1. Receiving the requisition/referral

There shall be verbal or written request from the referring physician or other appropriately licensed
health care providers which should provide appropriate information to demonstrate the medical
necessity of the examination and allow for its proper performance and interpretation.
The documentation of referring physician shall include:
Complete request form for a specific procedure to be performed on a patient to aid
diagnosis
Signs and symptoms and/or
Relevant history (including provisional diagnosis)
Details of any previous imaging performed for the same illness.
If request is verbal then a record must be kept (e.g. handwritten instructions by the practice personnel
onto request forms for additional services). Request shall be made by medical practitioner & signed by
the in charge radiologist.
2. Scheduling the examination

Selection of Imaging Procedure
Imaging procedures used shall normally be those previously developed and accepted as standard
practice. Selection of the procedure to be performed shall be those requested by the referring
physician. If the referring physician do not specify the procedure, the in-charge radiologist shall select
(and sign) the appropriate procedure according to the clinical details and need of the patient and
inform the referrer, where necessary. A detailed record duly signed by the in-charge radiologist for
such cases shall be maintained.
Imaging timeframe
There shall be a documented timeframe for imaging processes from point of registration to discharge
and to be made available in a clinically appropriate, manner to staff, patient and others.
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There shall be documented procedure for urgent and significant unexpected emergency patients;
3. Reception, Registration and transport of patient

The service shall ensure that there are written policies and protocols for reception, registration and
transport of the patient within the facility and within documented timeframe.
4. Patient information and consent regarding procedure, payment, report.
The Medical Imaging service shall ensure that the practices allow referrers and patients the opportunity
to communicate with the staff, access the facility to clarify request and monitor the standard of service
provided, while keeping confidential information related to referrer and patients.
Service fee information
Fee information shall be documented, displayed and provided on request, prior to the examination.
Patient informed consent and information on medical imaging examinations
All the patients shall have access to appropriate information to make an informed decision.
In general, Medical Imaging Centre shall provide following information specific to imaging services
provided:
Provision of useful information to the patient in relation to the examination procedure;
Advising the patient of the risks associated with the examination procedure;
Obtaining of patients consent;
Obtaining information from the patient in relation to any medication or medical condition which
may complicate examination;
Questioning of patient in relation to claustrophobia and advising the patient of available options
to reduce complications;
Provision for post examination care of the patient, where necessary;
Seeking feedback from the patient in relation to the quality of services provided.
5. Patient identification
There shall be procedure to ensure that every report is correctly identified to the patient. If required,
patient identification and detail must be verified. Records relating to any given patient shall be uniquely
identified through all stages of procedure.
Such records include worksheets, report, films etc. Identification may be achieved by use of:
Unique imaging number or

Patients full name or
Date of birth or
Medical record number
Discrepancies on the request/referral forms shall be recorded.

6. Patient preparation
There shall be documented protocols and procedures for patients preparation before the examination
procedure.
7. Patient sedation if required
There shall be documented protocols and procedures for identification of patients not suitable for
intravenous sedation in the absence of anaesthetist.
8. Performance of examination (protocols for imaging pathways and processes)
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a. There shall be documented Protocols describing the performance of all the procedures
performed by the practice personnel in that particular medical imaging centre.
b. In general, these protocols shall include all necessary information including that for:
a. Patient management;
b. Imaging procedures appropriate to specific clinical indications;
c. Deviation from standard imaging protocols;
d. Operation of the equipment;
e. Quality control procedures;
f.
Necessary remedial action e.g. adverse event management;
g. Records to be kept;
h. Emergency evacuation of the facility;
i.
Safety issue;
j.
Issuing of results.
9. Patient care during and after procedure

MIS shall allow referrers and patients the opportunity to communicate with staff, access the
premises to clarify requests and monitor the standard of service provided, while keeping
confidential information relating to other referrers and patients.
There shall be provision for communication to and from the patient during the process of
performing an imaging procedure on a conscious patient. The verbal communication could be
direct or through a system of microphones, speakers, receiver systems or bell or light
methods. The patient must be explained the use of such equipments before the procedure,
and encouraged to use the same when required. An unconscious or sedated or anaesthetised
patient shall be continuously monitored as per protocols by skilled personnel during the
procedure for parameters such as pulse, respiration, oxygen saturation, level of consciousness
etc.
Post procedure monitoring of patients for effect of sedation/anaesthesia; and for development
or resolution of effects of contrast/medication reaction shall also be performed as per set
protocols in specified aftercare area by skilled, authorised personnel.
Availability of resuscitation and monitoring equipments and medication in a crash cart shall be
mandatory for all MIS in area where such procedures are routinely performed.
Quality Improvement programme must be established under supervision of Radiologist to
monitor relevant issues in patient care during and after procedure. This should include
recording of adverse events during patient examination and system malfunction.
10. Interpretation and reporting
See chapter 2
11. Dispatch of report and advise regarding the result
MIS shall ensure that the interpretation of images and reporting is done by authorised
personnel within the specified timeframe in a specified format and language. The report along
with image records shall be signed and dispatched to the referrer; or handed over to the
37
patient/authorised person within specified period.

Unexpected findings requiring urgent attention shall be addressed as per set protocols and
procedures of urgent reporting and record for the same shall be appropriately maintained.
Regular review shall be performed on the time between the performance of the procedure and
issuing of written report.
12. Discharge of patient
MIS shall have documented policies and procedure regarding discharge of the patient after the
procedure.
The patient shall be given complete information about the procedure, its outcome and
instruction regarding time & procedure for procurement of written report/imaging record at the
time of discharge.
MIS shall be responsible for the transport of a patient requiring continuous medical
attention/monitoring as per preset protocol and procedure.
CS 2
Medical Imaging service ensure that the delivery of services is patient

focused.
The Medical Imaging Services shall ensure that service delivery is patient focused and respectful of the
individual patient and their specific requirements. This is achieved through provision of appropriate
information and support for patients and carers with due regards to differences in culture, religion,
caste, age and other factors.
Roles and responsibilities of each person coming in contact with the patient shall be defined by the
management. All measures to actively promote patient privacy, dignity and security shall be in place.
The MIS shall ensure that patients are involved in decision about their examination and procedures
through the process of procurement of valid and informed consent.
The language and format of written and verbal communication with the patient and their carer shall be
such that they can understand.
Concern toward patient safety shall be uppermost during patient handling, transport, stay and
performance of procedures.
Practice developed Procedures

There may be instances where standard protocols/procedures will need to be amended to
accommodate the particular diagnostic needs of the patient according to presenting features and/or
clinical details e.g. Instead of abdominal, trans vaginal ultrasound in obstetric imaging, opposite hip
scanned for DEXA due to past surgery. In such cases, medical imaging centre shall have record and/or
request form of the reason(s) duly signed by in-charge radiologist.
Any changes offered/adopted shall have benefit to the patient over those currently in use.
Patients Complaints/grievance
Patient shall be given opportunity to express any grievance they may have towards the service/service
38
personnel. Their complaints shall be recorded by the authorised person. Immediate cognisance and
remedial action must be initiated, if such is warranted. The same shall also be recorded and reported.
Follow-up action taken to improve services so as to prevent recurrence of similar instances in future
shall also be recorded and reported to management, and the complainant.
Confidentiality and respect shall be evident in all instances of patient complaint/grievance handling by
the MIS personnel.
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Chapter 2
CPP1 Medical Imaging Service ensures the acquisition of optimal diagnostic
The medical imaging services shall ensure that all images are acquired in accordance with agreed
protocols, by competent staff, working within their defined scope of practice and provide essential
image characteristics.
The imaging protocols shall address general population as well as provide for specific modifications in
case of children or adult with special requirements.
The SOPs shall be developed in collaboration with the radiologist and technicians and communicated
to those performing the examinations. The radiologist in charge shall ensure uniform implementation of
the protocols and monitor any deviations. The SOPs shall be reviewed, modified and updated at
predefined regular intervals
The quality of images shall be verified by the technician as well as by the supervising radiologist in
terms of its technical nature and also for the diagnostic content relevant to the patient condition.
A noncompliance if any, occurs shall be documented and recorded. It includes variation from
documented management requirements (e.g. Use of uncontrolled Documents, unacceptable quality
control results, unacceptable equipment calibration,) and procedural management (wrong patient
identification on the image or issued report). The event can occur at any stage of medical imaging
service, from the time that the patient presents at the practice through to the issue of the final report.
These non compliances shall be identified by complaints from practice personnel or external referrer,
internal audits, management review etc. And there shall be an appropriate record of action taken to
rectify the problem.
There shall be a record of documented procedure so that the staffs are aware of the action to be taken.
These documents shall also need to define who is responsible for overseeing the remedial action
required and ensuring that it has been successful in resolving the problem.
A record of remedial action taken must be maintained, for example
Steps taken in response to unacceptable equipment calibration results;
Re-imaging of a patient due to unacceptable image quality;
Re-issuing of report due to incorrect patient details.
The corrective action taken must be monitored to ensure effectiveness and record for the same shall
be retained for future references and audit.
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CPP 2 Medical Imaging Service ensures the quality of reports (clinical and
technical)
Reporting timeline
There shall be a documented timeline for written report to be made available in a clinically appropriate,
manner.
There shall be documented procedure for reporting urgent and significant unexpected findings; The
radiologist shall use reasonable endeavours to communicate directly with the referrer or an appropriate
representative who will be providing the clinical follow-up for findings thast bear an immediate effect on
patient management.
Image Reports
All studies shall be interpreted and reported by a radiologist. The written and confirmed report duly
signed by the in-charge radiologist shall be sent to the referrer or other health care provider providing
the clinical follow-up.
These reports shall be handed over to the patient/person authorised by the patient/guardian in case of
minor.
A record shall be kept of the time and date of report, recipient of report and the reporting staff member.
There shall be documented protocol and procedure for the following:
Mechanism and authority for the release of urgent results
Provision of advice in relation to follow-up studies or additional examination
Release of result by telephone, fax or other electronic means
Release of result to the patient
Confidentiality of results and other patient records
Retention, storage and retrieval of records and reports.
Imaging reports shall in general include the following:
A title e.g. imaging report;
Name and address of the medical imaging centre, and location/site where the procedure(s)
was performed if different to the practice address on the report;
Referrer name;
Date of issue of report;
Unique identification of patient i.e. Full name and date of birth or medical record number;
Date of imaging procedure;
Identification of the modality used;
Imaging procedure(s) result, and where appropriate, the unit of measurement
Detail of radiopharmaceuticals administered, including type and dose of isotope, the time and
means of administration, and the identity of the person or persons responsible for the
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administration;
Where necessary, an explanation of any modifications to the procedure as identified in the

practices procedure manual;
Adverse reaction to the radiopharmaceuticals administered;
Incidental observations or findings not specifically related to the examination requested;
Notification of preliminary results by telephone to the referrer, prior to issue of the final
diagnostic report;
Seeking second opinions for difficult to interpret or ambiguous images or for images arising
from highly specialised examination procedures Seeking second opinions for difficult to
interpret or ambiguous images or for images arising from highly specialised examination
procedures
Opinion and interpretation where relevant;
Correlation with previous imaging details/other relevant clinical details if available
Advice in relation to follow up studies or additional examinations
Name and signature of reporting radiologist.
Amendment to report
When a report is found to be invalid after issuing, the original report shall be withdrawn and replaced
by a report which is clearly identified as a replacement report.
CPP3 Medical Imaging service ensures quality of interventional procedures

Interventional procedures performed in the department shall be in accordance with the previously
developed protocols, by competent staff working within their defined scope of practice.
The MIS shall encourage formation of team of competent members with complementary skills and
experiences for providing a specific interventional service.
The expected result from the procedure shall be reasonable as communicated to the patient with
detailed information about the risks involved. Informed consent, opportunity to seek second opinion
and selection of person performing the procedure shall be treated as rights of patient and he/she shall
be offered opportunity to express the same.
The results of the interventional procedure performed shall be recorded and effort shall be made to
achieve the result comparable with the benchmark result of best practices in field.
CPP 4 Medical Imaging service ensures proper management of drugs and

contrast media
The medical imaging services shall ensure that drugs including controlled drugs and contrast media
are prescribed, prepared and administered safely to reflect statutory requirements. System should
reflect differences between adults and children.
42
All drugs and contrast media shall be stored as per guidelines of the manufacturer for storage of that
particular drug/contrast media.
There shall be checklists to identify patient at higher risk to develop adverse reaction to administered
drug to contrast media shall be developed and used.
Patient receiving drug and contrast media shall receive continuous care and monitoring during and
after their administration.
All adverse reaction shall be dealt with, efficiently and effectively, as per set guidelines by trained
personnel/teams.
Information about adverse reaction shall be recorded and included in patients report
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Chapter 3
(CFE) Control of Facility and Environment
CFE 1 Medical Imaging service ensures proper management of facility
Roles and responsibility
The medical imaging centre shall have a process to provide radiological services which shall be
maintained free of hazards for patients and personnel and at the same time providing quality services
for effective diagnosis.
Location and surroundings:

The roles and responsibilities for each area of the facility and environment management shall be
defined according to area service or service managed.
Proper signage in language(s) and format in accordance with the served population shall ensure
guidance to and within the facility of the medical imaging services
The medical imaging service shall be located in such a way that it is easily accessible to patients,
service providers and ambulances. The ground floor is the most suitable to accommodate and it should
have adequate space for future expansion away from traffic, which is also away from open sewerage,
drain, public lavatory or similar unhygienic surroundings.
Building: The building of medical imaging centre shall be constructed in such a manner so as to
permit operation of various medical imaging services (as in scope of services) under strict hygienic
conditions; with comfort and efficiency of operation and ease of movements.
The MIS shall adhere to building laws of the region, and there shall be no deviation of the design of the
building from that authorised as per plan.
The MIS shall be designed for dimensions as per guidelines laid down by AERB
MIS shall be well lighted, ventilated and screened (mesh) whenever necessary.
The walls and floor of the rooms where imaging equipments are placed shall be smooth, washable and
capable of being kept clean. Drains shall be of adequate size and directly connected to sewer.
There shall be adequate method of management of biomedical waste and excreted radioactive
substances to prevent any hazards.
Temperature and humidity control for patient comfort as well as for the machine to perform within
specifications;
The MIS shall be designed to minimize the risk of injury and occupational illness
The MIS shall be designed to protect from biological, chemical, radiation or any other recognized
44
hazards.
Provision for the safe emergency exit from the site shall be maintained and signage to indicate them
shall be in place.
Accommodation of centre:
Medical imaging centres should be expected to adequately provide for at least the following items
relevant to accommodation:
Patient waiting area;
Patient interview and preparation area;
Patient change cubicles -These should be Pb lines with 3 mm commercially available Pb, if the
cubicles are within the x-ray examination room;
Facility for the secure storage of patients belongings;
Radiation Protection Signage in relation to restricted areas;
Equipment console and operating areas;
Separate area for stabilizers/transformers/UPS system for back-up;
Area for resuscitation equipments and medication in crash cart trolleys;
Film viewing and reporting areas;
Facilities for performance of administrative duties;
Sterilisation cum washing room;
Store cum record room;
Areas for storage of equipment accessories and consumables;
Provision for storage of equipment related to fire safety and other safety measures
In addition to the above general accommodation requirements, the concerned facility is expected to
provide for at least the following specialist items relevant to the accommodation of particular equipment
in that facility:
Radiology
Building plan as per the guidelines of AERB, department of radiation protection;(see Section
C)
Area of the room shall be adequate depending on the size/type of equipment installed (AERB);
Construction design as per guidelines of AERB.
Mandatory AERB certification for facility and installation.
Signage and red-light indicator identifying restricted area for radiation safety.
Facility for loading, uploading, developing and processing of X-ray film; The dark room must be
fitted with an exhaust fan.
Facility for Special X-ray, fluoroscopy with IITV;
45
Facility for barium preparation;
Attached bathroom and toilet facility for patients
Availability of crash-cart trolley; with emergency medicine tray and oxygen cylinder;
Ultrasound
Signage in accordance with PNDT act (see section 3)
Size of the facility shall be adequate with adequate ventilation, temperature and humidity
control;
Private examination rooms and provision of screens/shields/covers providing proper privacy for
patients undergoing sensitive examination;
Facility shall provide presence of at least one female staff during procedures on female patient;
Emergency recovery facility for interventional procedures like FNAC, drainage of abscess &
collection;
Facility for obtaining print outs and hard copies of the image;
Separate toilet facility;
Mammography
Facilities for changing for patients;
Facilities for examination and reporting areas;
Facility shall provide presence of at least one female staff during procedure;
Bone mineral densitometry
Equipment area for conducting examination;
Image processing and reporting area.
Nuclear medicine
46
Radioisotope preparation and storage facilities Hot Lab
Radiopharmaceutical administration area
Radioactive Scanning facilities with dimensions approved by AERB.
Delay Tanks and separate Ward if I-131 therapy for thyroid ablation dose are given
Safe waiting area for the attendants and visitors to the department with toilet/washroom.
Patient recovery area
Personal decontamination facilities
Controlled access to imaging room and appropriate signage
Facility for communication with the patient being examined
Sedation and general anaesthesia facilities
Patient toilet facilities specific to nuclear medicine with drain straight to the municipal drain
without mixing with the hospital drain;
Construction and design to minimise effects of magnetic and RF Fields on the surroundings;
The wooden doors to MRI scan should possibly be painted with fire retardant paint. (Check
paint for magnetic properties before use);
Definition of 5 gauss line;
Controlled access to the imaging room and appropriate signages informing patient and staff
about magnet sensitive objects/devices;
Temperature and humidity control for computing equipment with monitoring on daily basis;
Indications for detection of helium boil-off and/or oxygen depletion;
Apparatus with communication with the patient during examination eg. speaker- receivers, bell,
light system, cameras for patient observation;
Sedation, GA facility and MR compatible equipment for patient monitoring during sedation;
Pipelined gases and suction facilities;
MR compatible anaesthetic equipment for resuscitation and crash cart trolley;
The MRI room should have a fire Alarm system, checked weekly;
MRI
CT SCAN
Controlled access to the imaging room and appropriate signage and red light indicators for
restricting access;
The doors of CT scan must be Pb lined as per AERB guidelines for radiation safety;
The wooden doors to CT scan should possibly be painted with fire retardant paint and lead
lined;
Temperature and humidity control for computing equipment;
Facility for communication with the patient during examination eg. speaker- receivers, bell, light
system, cameras for patient observation;
Radiation protection facilities for the patient and radiology staff Radiation badge(Rule of 10 for
pregnancy)
The room must have sufficient no. of Pb aprons, 0.5 mm Pb eq., Thyroid protection shields,
Gonadal shields, eye and possibly breast shield as well.
Sedation and GA facility with facility for patient monitoring during sedation;
Availability of crash-cart trolley with emergency medicine tray and oxygen cylinder.
47
The CT room should have a fire Alarm system, checked weekly.
Interventional procedures
The angiography suit/image guiding suite of sufficient size.
Availability of sterile/autoclaved clothing, equipment and material
Facility for hand wash and change of clothing for staff and patient.
Emergency switches on the machine in the examination room.
Fluoroscopy timer switch
The room must have sufficient no. of Pb aprons, 0.5 mm Pb eq., Thyroid protection shields,
Gonadal shields, eye and possibly breast shield as well
Equipment and medical record storage space, consultation space, and rest room;
Equipment and facility for decontamination/sterilisation/storage/supply of equipment and

material.
Room with all fixed and movable hardware such as physiological monitors and any patient
support system;
Adequate space for operating team and support personnel;
Admitting privileges for critical or elective patients.
Anaesthesia equipment like Boyles apparatus, compatible with the imaging modality used.
Relevant statutory requirements (See Section 3 Annexure 1)

It shall be responsibility of each practice to ensure compliance with legislative requirements.
CFE 2 Medical Imaging service ensures proper management of environment

Medical Imaging Services shall ensure that the management is able to respond appropriately to any
major external or internal incidents that risks the safety of the staff, patient, relative, facility or the
equipment. The continuity of care and service to patient during the time of incident management shall
be ensured.
The occurrence of such incidents and the response shall be analysed and findings disseminated to
those concerned. The information thus gathered shall be used for implementation, improvements and
modification in procedures/plan to augment future safety.
Medical Imaging services shall have process to minimize and respond to environmentally related risk
to the health and safety of employees. This includes immunisation.
48
Chapter 4
CP 1
Medical Imaging services ensures authorization, management and

The service shall be responsible to ensure that the staff are competent, skilled and supported to
maintain improve and widen the scope or their competencies through suitable opportunities for training
and education provided to them.
Radiologist
General Radiology
The radiologist understands the basic technology of image acquisition, transmission, manipulation,
processing, archival, retrieval, and display including the strength weakness and limitations.
He shall be knowledgeable in how to optimally utilise the image viewing equipments
The interpreting radiologist must be familiar with the principles of radiation hazards & radiation
protection to both the patient and the radiological personnel
The interpreting radiologist shall be responsible for the quality of images being reviewed and
Understand the elements of quality control.
Ensuring appropriate quality assurance procedure are performed including quality control of
instruments, procedure, radiopharmaceuticals and blood and blood products;
Preparation and maintenance of the procedure manuals
Ultrasound
The radiologist in-charge of ultrasound imaging shall be responsible for patient care, performance of
procedure, equipment care, image and report generation for every scan/study performed.
All radiologists shall specify use of contrast agents and assure the quality of both images and
interpretations.
49
Nuclear medicine
Radiologist / medical specialist shall be responsible for the quality and safety of all procedure
performed by the personnel performing at the unit including
Ensuring staff are properly trained and competent;
He shall make a formal assessment of the patient prior to the administration of unsealed ources taking
into account patients overall medical history and treatment given;
Select the radionuclide and dose for each individual patient based on that formal assessment.
Technologists
In general, responsibility of the technologist shall include following
Patient preparation;
Patient positioning;
Operating the equipments;
They shall follow safety measures to prevent unnecessary exposure to radiation, to

themselves, their patient, and their co-workers;
Adjustment and maintenance of medical imaging equipment;
Monitoring of inventory levels, ordering for materials and supplies in accordance with
established policies and procedures;
Knowledge of the informal policies, procedures and practices necessary to conduct the
normal function of a specific section, unit, or work area;
Quality control procedures
Patient record keeping;
In addition to these general requirements, there are a number of other specific responsibilities to
imaging service provided. These activities include the following:
Radiology
50
Radiologic technologists shall take X-rays and administer non radioactive materials into
patients bloodstream for diagnostic purpose;
Produce X-ray films of part of the human body;
Develop X-ray films;
Measurement of thickness of the section to be radio graphed so as to produce radiographs of
the appropriate density, detail, and contrast;
They shall be experienced to perform complex imaging procedures e.g. Fluoroscopy

They shall wear badges, lead aprons, gloves, and other shielding devices to minimize radiation
hazards, and detailed records are kept on their cumulative lifetime dose.
Mammography
Mammography technologist along with general requirement shall use low dose X-ray to
produce images of the breast.
Ultrasound
To assist physician with biopsy procedures, guiding biopsy instrument using sonographic
techniques; performing invasive ultrasound procedures, Doppler vascular examinations, deep
abdominal studies and colour-flow ultrasound as required.
Determine, prepare and set up medical supplies, instruments and equipment
Assist medical and professional personnel during diagnostic procedures to include handling
instruments, operating and monitoring equipment and calling out equipment readings; alert
physician to patient's discomfort or changes in condition.
Evaluate technical quality of films to obtain representative images of pathogenic conditions;

process film in accordance with standard procedures or techniques
Maintain records of ultrasound films taken, archiving and de-archiving data as required;
calculate, Compile and record data from numerical readings on patient's charts and related
documents
Placement of regions of interest for assessment of BMD measurements
Monitoring the patient during the procedure and obtaining the measurements prescribed by the
supervising physician.
Scan analysis
Review of results
Review of quality control results.
Performing routine quality assurance procedures and precision testing.
Nuclear medicine
They shall have theoretical knowledge of gamma camera and PET/CT applications and
operation in medical diagnostics.
o
Radiopharmaceuticals preparations
Administration of radionuclide
51
Imaging, under supervision of specialist.
Complies with biohazards/radiation safety standards through proper handling of hazardous

chemical and biological agents and/or radiation sources in work place;
Following safety protocols when working with radiopharmaceuticals in order to limit the
patients and technologists exposure to unnecessary radiation;
Keeping accurate records of the type, amount and effect of radionuclides administered;
Positioning for MRI examinations, application of appropriate surface receiving coils and
obtaining MRI Data in a manner suitable for interpretation by the radiologist Ensuring that the
necessary quality assurance of the MRI system is undertaken MRI Technologist must act
under the supervision and direction of the radiologist responsible for each patients
examination.
MRI
CT scan
Monitoring the patient during examination;
Obtaining the data in a manner prescribed by supervising radiologist;
Technologists should be trained in administration of intravenous contrast material under

supervision of radiologist.
They shall perform regular quality control testing of CT system including basic calibrations as
instructed by the radiologist/maintenance engineers.
Interventional radiology
CP 2
Provide assistance to the Radiologist performing the procedures and ensuring completeness
of the consent form before the start of procedure.
Medical Imaging service ensures that the staff is competent to deliver

the service assigned to them.
The service shall ensure that the management of staff is effective, fair, consistent, supportive and in full
compliance with current best practice.
There shall be defined policies and procedures for employment and applied consistently.
Radiologist
Radiologist must hold:
52
Degree in Medicine (M.B.B.S) with post graduate Degree in Radiology / Nuclear Medicine (M.D)
with minimum 1 year Clinical experience in the respective field.
OR
Degree in Medicine (M.B.B.S) with Diploma in Radiology with minimum 3 years experience in the
respective field
(The Degree/Diploma being recognised from Medical Council of India /State Medical Council)
Technical Personnel
Radiology technician shall be full time competent staff possessing:
10+2 or equivalent examination passed with science subjects from a recognized board;
And
Radiographers/X-ray technologist course of minimum one year duration (including in-field training in
diagnostic radiology) passed from a recognized institution with six month experience in related field of
imaging services.
(The Degree/Diploma being from University/Institution recognised by the Central Government or State
Government)
Along with general qualification he shall also have following specific requirements:
The training shall include:
I.
Image acquisition technology
II.
Image processing protocols
III.
Proper selection of examination specific option
IV.
Image evaluation
V.
Radiation dose indicators
VI.
Patient safety procedures
*All technical personnel working in medical imaging centre shall be trained for BLS training with
refresher course every year.
Nurses
General
Each nurse shall possess
10+2 or equivalent examination passed with science subjects from a recognized board;
And
Nursing course of minimum three year duration passed from a recognized institution with six month
experience in related field of imaging services.
Nurses involved in medical imaging services shall have adequate training and experience in such
practices.
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Training/experience in resuscitation
The practise shall ensure that there is adequate training in CPR, appropriate management of contrast
reaction and the use of resuscitation experience.
There shall be designated staff member at each site to ensure resuscitation equipments and drugs, etc
are present in state of readiness
Anaesthetist
Staff administering general anaesthesia shall be trained anaesthetists with appropriate assistance.
Degree in Medicine (M.B.B.S) with post graduate Degree in Anaesthesiology (M.D) with minimum 1
year Clinical experience in the respective field.
OR
Degree in Medicine (M.B.B.S) with Diploma in Anaesthesiology with minimum 3 years experience in
the respective field
The Degree/Diploma being recognised from Medical Council of India /State Medical Council
Ancillary staff
ttt
There shall be appropriate staff at the reception, store, quality management, security, ambulance etc.
management, security, ambulance etc.
There shall be appropriate staff at the reception, store, quality management, security, ambulance
There shall be appropriate staff at the reception, store, quality
etc.
Along with general qualification radiologist shall also have following specific requirements:
General Radiology
Along with above qualification Radiologist shall have working knowledge of digital imaging services
including all from acquisition to display that affect the image quality and that have the potential for
producing artefacts.
Mammography
Each radiologist should have been trained to interpret mammograms on a regular basis during his/her
training.
Ultrasound
Each radiologist must have experience and knowledge in performing and interpreting diagnostic
ultrasound (500 ultrasound cases in that speciality area shall have been interpreted and reported
during his/her training).

The Radiologist shall have knowledge and understanding of:
54
Bone structure, metabolism, and osteoporosis
Process of QCT data and image acquisition
Reporting parameters and criteria for accurate and precise comparison of serial changes
Alternative bone density techniques, such as central and peripheral DXA, RA, QUS etc.
Reporting and making clinical recommendation about incidental findings on QCT images
such as mass lesions, adenopathy etc.
Nuclear medicine
Radiologist working in the field of nuclear medicine must hold a similar degree in Radiation Medicine
(MDRM/DRM) from a recognised institute
(The Degree/Diploma being recognised from Medical Council of India /State Medical Council)
Radiologist shall also comply with:
Nuclear medicine practises with use of radioactive substances.

Include professional, scientific, consultative or advisory organisational, administrative and
educational matters. These shall be relevant to the services offered by the centre.
Training for Radiation safety measures (level II).
The radiologist shall have experience in nuclear medicine therapy procedures and have adequate
training and practical experience. He/She must be located on site through-out the procedure and
responsible for all component of each nuclear medicine service including
Personal attendance
Determining the appropriateness of and monitoring the quality procedure
Assessing and influencing outcome of procedure
Providing a final consultation report
Magnetic resonant imaging (MRI)

The supervising radiologist must have evidence of competence in the techniques and application of
MRI of the brain, spine, musculoskeletal system and other relevant anatomic regions (500 MRI cases
in that speciality area shall have been interpreted and reported in past 36 months in a supervised
situation. For neurological MRI, at least 50 of the 500 cases shall have been MRA or the central
nervous system.)
Each MRI unit must have one or more supervising radiologists with overall responsibility for running the
unit.
Computed tomography (CT Scan)

The radiologist shall have a thorough understanding of CT technology and instrumentation as well as
radiation safety (500 CT Scan cases in that speciality area shall have been interpreted and reported in
past 36 months in a supervised situation)
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Each radiologist must meet the training requirements and should have evidenced experience of
performance of interventional procedures that he/she is performing at the MIS.
Training for Radiation safety measures (RSO level I)
Special training for resuscitation measures.
CP 3

The service shall periodically review clinical and nonclinical practice and workforce deployment.
Regular periodic review of performance and knowledge of the personnel shall be performed and the
record for the same shall be maintained.
There shall be defined protocols & policies for employment, re-employment, deployment, promotion or
transfer of a person in the MIS.
There shall be defined protocols & policies for the team of radiologist, technician, nurses, ancillary staff
working at each station/each area of imaging.
Quality indicators to monitor various service parameters shall be identified, recorded and reassessed
after implementation of improvement/corrective management.
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Chapter 5
CE 1
Medical Imaging services manages and monitors appropriate

procurement and installation of the equipments and consumables.
The medical imaging service shall be furnished with all the equipment that is required for the provision
of services ( including X ray, ultrasound, mammography equipment, bone densitometry equipment, C T
Scan, MRI, gamma camera and associated nuclear medicine equipment, etc.).
The medical imaging services shall ensure that procurement and installation of the equipments are as
per established policies and procedure to conform specified performance criteria and/or regulatory
requirement and are obtained only from approved supplier.
Supplier must be selected on the basis of their ability to meet specified requirement. There shall be a
policy based on specified requirements for selection of supplier. A list of all suppliers, contractors and
consultants must be maintained.
There shall be procedure for maintenance of record of purchase. Purchasing document shall describe
the product being ordered, specification requirements and relevant information to that order.
There shall be procedure and recording of verification and inspection of the purchased products and
services at appropriate intervals.
Purchased materials and products shall be stored in designated storage areas within the facility. There
shall be policy for storage methods to prevent damage and deterioration of product prior to use
Equipment specification
Radiology
There shall be Installation of Type Approved machines only for medical diagnostic purpose.
(Obtain from the vendor/seller of the X-ray machines a copy of the AERB Type Approval
certificate prior to purchasing the unit).
X ray machine shall be of 500 MA/300MA,dental X ray 6MA and OPG X ray 4.5 to 10 MA;
Acquisition of X-ray equipment shall be registered with the competent authority by the person
acquiring the equipment.
No X-ray equipment shall be commissioned unless it is registered with the competent

authority.
Decommissioning of X-ray equipment shall be registered with the competent authority
Automatic film processor;
There shall be appropriate resuscitation equipment available on site for contrast reactions.
Mammography
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There shall be dedicated mammographic equipment which has adequate device for
compression and a grid.
There shall be low radiation and biopsy attachment.
Ultrasound
Automatic film processor unit.
Registration under PNDT act and its status of implementation.
Permanently In-house USG equipment;
If portable USG then registration of the equipment with transport facility
Equipment for vascular studies shall be capable of colour Doppler imaging;
Equipment shall have convex, sector, linear probes of frequency ranging from 3.5 to 10 MHz
Transvaginal probe shall be available for pelvic and obstetric scans.
Shall have minimum of three probes (transvaginal, transrectal)
Software with normal young adult and age-matched and sex-matched control population
standards specific to the equipment;
A phantom or other calibration standard to evaluate the accuracy and precision of BMD
measurement
Nuclear medicine
For the supplied radiopharmaceuticals and blood products used in nuclear medicine from
external suppliers.
Radiopharmaceutical Preparations:
o supplier must be appropriately licensed;
o radiopharmaceutical identification must be verified by checking the label;
o the quantity of radioactivity to be administered to each patient must be verified by
measurement and recorded;
o If there is a significant discrepancy e.g.>10%, between measured radioactivity and label
data or prescribed dosage, administration of such substance shall be deferred until the
problem is resolved.
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Blood products:
o The product label must be verified for patient identification;
o The radioactivity must be verified and discrepancies of >10% from the stated activity
clarified with appropriate; personnel prior to administration.
Equipment for sedation and monitoring of sedated patient shall be available on site
If intravenous sedation is performed there shall be equipment for continuous pulse oximetry
Equipments and drugs for the management of potential complication shall be immediately
available
For paediatric patient, sedation monitoring equipment shall be capable of measuring saturating
end tidal CO2 and non invasive blood pressure
There shall be equipment for endotracheal intubation of children in case of complication

If clinical exercise stress testing is performed, there shall be equipment available for it
Where appropriate to the patient population and procedure performed, equipment for general
anaesthesia and monitoring of the patients shall be available on site
Where warranted there shall be appropriate resuscitation equipment available
Facilities shall be available for cardio pulmonary resuscitation and basic life support
appropriate to the level of cardiac stress testing performed
CT scan
Whole body CT scan with scan cycle of less than 1 second(sub second)
Installation of the equipment shall be approved by AERB
Facilities shall be available for resuscitation and basic life support of the patients like Boyles
Trolley, Suction machine, emergency drugs to combat any allergic reactions due to contrast
medium.
MRI equipment shall meet the requirements for safety-magnetic resonance equipment for
medical diagnosis.
MRI Equipment shall also meet essential health and safety requirements for a wide range of
products, including machinery, electronics, medical devices and telecommunications
equipment.
Automatic film processor unit.
MRI
There shall be fixed high resolution image intensification system with at least a 25cm field,
digital acquisition and subtraction for sites performing angiography.
Mobile intensifier are not recommended for diagnostic angiography on routine basis as they
have limitation in image quality & stored image data handling, increased contrast material
requirement, increase radiation dose to patient, and inferior image in thick body part.
The angiographic injector shall be capable of varying injection volumes and rates.
The angiographic injector shall have appropriate safety mechanism to prevent over-injection.
For Tier A procedure monitoring of ECG & Blood pressure must be available, and for
unconscious or sedated patient there shall be use of pulse oximeter.
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For Tier B procedures there shall be comprehensive physiological monitoring (ECG, BP, and
Pulse oximetry).
For pulmonary arteriography and peripheral and visceral diagnostic angiography there shall
also be direct pressure monitoring for determining intravascular pressure gradients..
There shall be sufficient supplies of devices for the range of interventional procedure
performed and for treatment of possible complications.
Fixed installation X Ray equipment, designed and specified for interventional procedure;
Transcutaneous ultrasound;
Intra-arterial ultrasound;
Tissue ablation devices, e.g. Radiofrequency, cryotherapy, lasers microwaves and associated
probes;
Arthectomy devices with associated catheter and heads;
Thrombectomy devices with catheter
Equipment inventory
The inventory shall include all imaging, monitoring and resuscitation equipments and shall include the
following information in addition to that prescribed in ISO/IEC 17025:
CE 2
Notice/certificate of registration or license where available

Quality control record
Safety testing record
The service manages and monitors appropriate operation and working

of the equipments to deliver the service.
The medical imaging service shall ensure that only authorised personnel shall operate the equipment.
There shall be up-to-date instruction on the use and maintenance of the equipment (including relevant
manuals and direction for use provided by the manufacturer of the equipments and documented
imaging protocols and procedure manuals describing performance of all procedures performed by the
practice) and readily available to personnel. Personnel operating equipment shall be responsible for
checking the performance and performing basic calibration of all the equipments. They shall also
maintain logs of performance and calibration as well as consumption of consumable material.
Records shall be maintained for each equipment and shall be available for inspection, at all reasonable
time, to the competent authority or its representative, to ensure compliance with the code. These
records shall include at least the following:
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Identification of equipment
Manufacturers name, type, identification and serial number or other unique identification
Manufacturers contact persons and telephone numbers
Date of receiving and date of putting into service
Current location, where appropriate
Condition when received (new, used or reconditioned)
Manufacturers instructions, if available, or reference of their retention
Equipment performance records that confirm the equipment suitability for use
Maintenance carried out and planned for the future
Damage to or malfunction, modification or repair of the equipment.
CE 3

maintenance and repair of the equipment to deliver the service.
The Medical Imaging Services shall ensure that maintenance of all Equipments and corresponding
records are performed as per preset guidelines and SOPs by authorised personnel.
The service shall also ensure that maintenance of contract with authorised as well as external authority
are kept updated. Regular preventive maintenance and calibration of all equipments shall be carried
out and recorded as per preset guidelines.
The services shall also ensure equipment failure and faults are monitored and managed and that
safety warnings, alerts and recalls are circulated and acted upon within specified time scale.
Equipment checks and Calibration

Check is a measurement of at least one point in a range of a measuring instrument or system or
material against a known value to confirm that it has not deviated significantly from its original
calibrated value. It is also an examination of a condition of an artefact to determine that it has not been
adversely affected by constant use.
Calibration is a set of operations which establish, under specified conditions, the relationship between
values indicated by a measuring instrument or measuring system, or values represented by a material
measure, and the corresponding known values of a measured.
There shall be record of compliance test of all equipments at the time of installation, prior to regular
patient imaging and at least yearly by a qualified service engineer (AERB).these records shall be
available for inspection, at all reasonable time, to the competent authority or its representative, to
ensure compliance with the code (AERB). All medical imaging equipment at each practice site shall be
maintained in accordance with the requirements detailed in manufacturers documents and shall
comply with (if any) applicable law of the state.
Under no circumstances shall the completion of necessary equipment servicing or calibration be
delayed or cancelled in order to accommodate further patient examinations.
In general, calibrations shall be carried out by external calibrating authority or trained in-house
personnel and an endorsed test report is obtained for this work.
All the equipments shall be checked and calibrated for at least the following:
Calibration of signal to noise ratio
Check of signal uniformity
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Check of geometric distortion
Check of positioning accuracy
Check of phantom image quality
Check of signal optimisation using SMPTE
Check of light output of film viewing objects
Check of ambient light level in the film viewing box

Check of functioning of film processing units.
In addition to above all the equipment shall be checked and calibrated specifically for following:
Radiology
All X ray machine available shall be calibrated as per AERB guidelines
Calibration of mA
Calibration of kV
Calibration of timer
Calibration of dose index
Calibration of SNR
Check of collimeter/diaphragm/lead curtains
Check of positioning accuracy
Check of table movement and tilt
Check phantom image quality
Check of film processing unit
Mammography
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Collimation alignment check
Focal spot size measurement
kVp accuracy and reproducibility measurement
Beam quality half layer value(HLV) assessment
Automatic exposure control(AEC) check
Screen speed uniformity check
Breast entrance exposure management
Average glandular dose measurement
Artefact evaluation
Darkroom cleanliness check
Processor quality control check
Screen cleanliness check
Darkroom fog check
Screen film contact test
Compression force measurement
Ultrasound
Calibration of power output
Calibration of callipers
Precision error of measurements of the phantom or standard that do not exceed the
specifications or recommendations of the manufacturer and are less than 1%
Maintenance of CT system used;
Maintenance of the QCT software, phantom and associated accessories;
Recalculation of LSC (least significant changes) in case of replacement of a CT scanner,

replacement of CT X Ray tube, recalibration of CT scanner or modification to the QCT
accessory components.
Nuclear medicine
Dose calibration and constancy check
Reproducibility and linearity checks of the dose calibrator
Geometric correction factor check
Calibration of energy window setting
Check of signal uniformity, linearity, sensitivity and resolution
Check of geometric distortion and spatial resolution
Check of collimator absolute and relative sensitivity
Centre of rotation check
Pixel calibration
SPECT phantom reconstruction check
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Crystal energy resolution check
Molybdenum breakthrough check
Ambient radiation dose management
Radiopharmaceuticals sterility checks
Film processor checks
CT SCAN
Check of signal uniformityCheck of geometric distortion
Check of slice thickness and positioning accuracy
Check of phantom image quality
Check of signal optimisation using SMPTE
Check of light output of film viewing objects
Check of ambient light level in the film viewing box
Check of functioning of film processing units.
Calibration of mA
Calibration of kV
Calibration of dose index
Calibration of field strength
Calibration of rate of change of field strength
Calibration of RF power deposition (specific absorption rate)
Check of auditory noise level
Check of magnetic field strength homogeneity
Check of RF shield integrity
Check of ghost intensity
MRI
CE 4
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replacement of Existing equipment & planning for new equipment for
expansion of service.
The Medical imaging Services shall ensure equipment condemnation, replacement and up-gradation
are performed as per preset guideline so as to ensure continuity of care.
MIS shall ensure that the replacement of equipment or facilities or transfer of services to a referral
centre is available during downtime of any equipment. Prior information shall be given and displayed of
such downtime is planned.
CHAPTER 6
CDR 1 Medical Imaging Services ensures generation, completion, revision,
and others.
Medical imaging services shall define document and maintain procedures to control all documents and
information that forms its quality documentation.
Document control is a mean to ensure that only the latest version of approved documents are being
used by practice staff. The practice should assign personnel responsible of overseeing the document
control system.
Procedures shall be adopted to ensure that all documents issued to medical imaging centre personnel
as part of the quality management system are reviewed and approved by authorized personnel prior to
issue.
Document control shall include :
Document identification ( numbering/coding )
Version identification
Change control
Maintenance of master list document distribution
Archiving
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Practice shall be developed as an identification system that includes all documents A formal means of
change control must be established to ensure:
That only authorised changes are made to approved documents;
That all the changes are reviewed and approved prior to the amended document being placed
in use;
That all copies of the document in use reflect the change.
Documents are periodically reviewed, revised when necessary, and approved by authorised personnel
There shall be a master list, listing all the documents currently in use. Whenever new version is
created or a document is changed and updated to a new version, the master list must also be updated.
The master list shall include:
Document name
Document number
Version designation
Document location(s)
Procedures shall be established to describe how changes to documents maintained in computerized

systems are to be made and controlled.
Whenever a document is changed or withdrawn, one copy must be held in an archive. The issue date
and the date of withdrawal must be noted with the document. Archive documents shall be stored in a
manner to prevent loss or damage and to facilitate easy retrieval practices shall set retention times for
archived documents.
CDR 2 Medical Imaging Services ensures procurement and maintenance of documents

of legislative and statutory requirements related to facility, equipment and risk
monitoring.
The Medical Imaging Services shall ensure that all documents related to legislative and statutory
requirements as per Annexure 2 are maintained and updated regularly by authorised personnel.
CDR 3 Medical Imaging Services ensures maintenance and updating of personnel data
records of all staff.
The medical imaging services shall maintain records of the personal information, relevant educational
and professional qualification, training and experience, and competence of all personnel.
This information shall be readily available for reference to relevant personnel and may include:
Qualification, competence and registration record
Employment contract and record
Training record
Health and medical record(check-up and benefits)
Annual performance review records
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Complaints and grievance record

Retention/ renewal of contract/promotion record
Certification or licence if required.
Reference from previous employment, if required.
Job description
Record of continuing education and achievement
Record of identification of signature and initials.
Record of training attended
Competency evaluation
CDR 4 Medical Imaging Services ensures maintenance and updating of all equipment
related records pertaining to their purchase, operation, maintenance and
disuse.
Refer to Chapter 5 Control of Equipment.
CDR 5 Medical Imaging Services ensures maintenance of personal, medical imaging

and reports records of all the patients.
The medical imaging centre shall have policies, processes and procedure to ensure that records are
identified, reviewed, retained and that personal, medical imaging and reports records are created,
stored, and archived in accordance with record retention policies.
A patient record shall be maintained for each patient receiving services provided by the medical
imagingcentreanditincludes
Name of nearest relative or other responsible attendant
Identification of primary source of medical care/ referring clinician
Dates and time of visit
Signed informed consent
Operative reports
Reports of all laboratory and diagnostic procedures along with tests performed and the results
authenticated by the appropriate personnel
Patient records shall be current and confidential. Medical records and copies thereof shall be made
available when requested by an authorised representative of the patient or that State Health Authority.
Radiology
Name of nearest relative or other responsible attendant
Identification of primary source of medical care/ referring clinician
Dates and time of examination
Signed informed consent
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Mammography
There shall be Breast imaging reporting format prepared and duly signed by radiologist in charge. In
addition to the results of each examination following information shall also be reported:
The name of the patient and an additional patient identifier

The date of examination
The name of examinations interpreting radiologist
An overall final assessment
Current mammograms and records must be kept by the facility:
For at least 5 years, or

At least 10 years if no additional mammogram of the patient are performed at the facility, or
Longer if mandated by state or local law, or
Until a written request is made by or on behalf of the patient, to permanently or temporarily
transfer her records to a medical institution, her physician or health care providers, or to the
patient herself.
Ultrasound
Record of patient identification and referring clinician
Record of patients details as per PC-PNDT Regulation on relevant forms wherever applicable
(State Health Authority/Regulatory body).
Record of date and time of scan
Record of name and signature of performing radiologist
Record of sedation/any other medication if given
Record of report, image and further advice and shall be retained for minimum of 2 years

A permanent record shall be maintained, including
Patient identification, facility identification, examination date, image orientation, and unit
manufacturer and model
Clinical notes or patient questionnaire containing any pertinent history
Positioning, anatomical information and/or technique settings needed for performing serial
measurements.
Printouts of the images and regions of interest, if provided by the unit and BMD values
obtained.
For premenopausal women, men younger than age 50, and children, the BMD and Z score should be
reported for each site examination.
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For postmenopausal women, men age 50 and older, report should include the BMD for area density, T
score, and WHO classification at the hip; and for trabecular volume density at the spine.
The report should include whether the artefacts or other technical issue may have influenced the
reported BMD measurements
Nuclear medicine
A daily record of the names of all patient upon whom studies are performed shall be retained for
minimum of 3 years or according to the appropriate statutory requirements whichever is longer.
There shall be record of receipt, usage, administration, and disposal of all radio nuclides in compliance
with the licence conditions and applicable medical records and radiation control regulations.
There shall be record of storage, preparation and disposal of radioactive/radiopharmaceuticals
materials as per requirements of appropriate regulatory agency.
Patient record shall include following details:
Patient name and identification number;
Requesting practitioners name;
Type of nuclear medicine procedure performed(and explanation if some modification to the

procedure);
Type, activity, route, and injection site of any radioactive or non radioactive substance
administered to the patient;
Name of nuclear medicine technologist performing the procedure;
Date procedure performed;
Description of findings;
Interpretative information;
Identification of responsible nuclear medicine specialist;
Description of any adverse effect or unusual features prior to, during, or following the study;
Supplementary information e.g. Evidence of previous surgery;
Comment
for anger type gamma cameras if used;

for SPECT, details of acquisition and processing;
for other instruments such as multi-crystal cameras, thyroid uptake probe, etc.;
Records of patient sedation

Drug used for sedation and further management shall be recorded in the patients record details, along
with time of administration and details of any adverse reaction.
MRI
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Record of sedation/contrast/medication if given
Record of adverse reaction and remedial action taken
CT scan
There shall be permanent record of the CT examination and its interpretation.
Images of all appropriate areas both normal and abnormal shall be recorded in suitable
archival format.
An official interpretation of the CT findings duly signed by concerned radiologist shall be

included in the patients medical record.
Retention of the CT examination shall be consistent both with clinical need and with relevant
legal and local health care facility requirements.
Procedure or Operative record
Record of sedation/contrast/medication if given
Record of adverse reaction/complications and remedial action taken
Compliance Records and Corrective Action Record

A noncompliance if any, occurs shall be documented and recorded. It includes variation from
documented management requirements (e.g. Use of uncontrolled Documents, unacceptable quality
control results, unacceptable equipment calibration,) and procedural management (wrong patient
identification on the image or issued report). The event can occur at any stage of medical imaging
service, from the time that the patient presents at the practice through to the issue of the final report.
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These non compliances shall be identified by complaints from practice personnel or external referrer,
internal audits, management review etc. And there shall be an appropriate record of action taken to
rectify the problem.
There shall be a record of documented procedure so that the staffs are aware of the action to be
taken. These documents shall also need to define who is responsible for overseeing the remedial
action required and ensuring that it has been successful in resolving the problem.
A record of remedial action taken must be maintained, for example
Steps taken in response to unacceptable equipment calibration results;

Re-imaging of a patient due to unacceptable image quality;
Reissuing of report due to incorrect patient details.
The corrective action taken must be monitored to ensure effectiveness and record for the same shall
be retained for future references and audit.
CDR 6 Services ensures maintenance and updating of all records and

documents pertaining to audit, quality control & quality improvement of
all processes and services.
The Medical imaging services shall be oriented towards Quality maintenance and improvements
toward all processes and services. There shall be framework of Quality Management System to
organise and support operation of Quality System of the centre.
There shall be a staff member (quality manager), who is knowledgeable in quality processes, be given
responsibility for coordinating the implementation of the Quality Management System.
The scope of responsibilities and authority of the quality manager must be clearly defined and shall
include following:
Maintenance of the quality manual and associated practice documentation;

Identification and assessment of Quality indicators periodically to document improvement in
identified processes and services;
Monitoring of practice for verification of policies and procedures;
Ensuring validation of new procedures;
Investigation of technical problems, remedial action taken and verification of their
implementation;
Evaluation of calibration and maintenance of equipments;
Evaluation of results;
Evaluation of complaints and adequacy of reports;
Training and evaluation of internal auditors;
Scheduling and coordination of quality system audits;
Maintenance of training records of practice personnel;
Review of referrer and patient feedback;
Proposal of correction and improvements to the quality system.
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CDR 7 Medical Imaging Services ensures maintenance, integration, safety,

confidentiality and retrievability of all the records.
The medical imaging services shall identify a person responsible for maintenance, integration,
classification, safety, confidentiality and retrievability of all the records preferably in computerised
format.
There shall be defined protocols and procedure for confidentiality and retrievability of records and
same shall be implemented and monitored.
CHAPTER 7
RCS1 Medical Imaging service ensures that the risk associated with imaging
Radiation Safety Manual
The Medical Imaging Service shall ensure that organisation has arrangements and general radiation
protective measures for staff, patient and others to restrict exposure to imaging procedures/ionising
radiation. There shall be documentation of Radiation safety manual containing radiation safety policies
and procedures which aim to minimise radiation exposure in accordance with the ALARA principal
(i.e. as low as reasonably achieved). Example:
Procedure for handling and maintenance of X Ray machines, Fluoroscopy equipments, C T
Scanners, and other imaging equipments using radiation for imaging
Procedure for handling and maintenance of radioactive, chemical and biological spills;
Procedure for dealing with needle stick injuries;
Policies on the use of protective clothing and personal devices;
Policy on eating, drinking etc.;
Waste disposal procedures;
Immunisation policies;
Radiation Safety Officer
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Each medical imaging centre shall appoint Radiation Safety Officer whose responsibilities is to:
Ensure that practice is adhering to the relevant legislation of the state
Monitor changes in the legislation
Coordinate record keeping related to radiation safety

Proper interpretation of quarterly reports of TLD badges and in case of alarming results taking
appropriate action
Must ensure proper calibration of all the radiation equipment and conduct test which is
checked for focal spot, beam alignment etc, including calibration of equipments.
Signage and restricted access areas

The Medical imaging service shall ensure that there are appropriate signages and hazardous warning
notices
There shall be proper display of radiation and safety signs and boards like:
signs of identification of safety equipments such as fire extinguishers, showers, eyewash

facilities
signs to identify hazards and hazardous activities
signs to delineate public areas from area of restricted access.
Evacuation routes used in case of emergency shall always be kept clear (should not be used
as general storage areas).
Spill kits shall be available for acids and solvents;

Detailed log of radiation exposure and leakage monitoring must be maintained for all radiation related
imaging equipment.
Patient safety
MIS shall ensure that risk associated with imaging procedures are defined, assessed and minimised to
the patient.
Radiology
The X-ray unit design shall be type approved by AERB;
The room layout design of the room for housing the x-ray unit shall be approved by AERB.
The rooms housing diagnostic x-ray units and related equipment should be located as far away
as feasible from areas of high occupancy and general traffic such as maternity and paediatric
wards and other departments of the hospital that are not directly related to radiation and its
use.
The layout of rooms in an x-ray department should aim at providing integrated facilities so that
handling of x-ray equipment and related operations can be conveniently performed with
adequate protection.
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Unnecessary doors and windows present in an existing room, where x-ray machine is installed
should be bricked off and if not possible should be provided with adequate lead lining (2.0 mm)
and kept permanently closed.
The doors and passages leading to the x-ray installation should permit safe and easy transport
of equipment and non-ambulatory patients.
The dark room should be so located that the primary x-ray beam cannot be directed on it.
The room housing the x-ray equipment must be spacious enough to permit installation and
servicing of the equipment and operation of the equipment with safety and convenience for the
servicing personnel and operators as well as the convenience for patients.
Appropriate structural shielding shall be provided for the walls, the ceiling and the floor of the
x-ray room so that the doses received by workers occupationally exposed to radiation and the
members of the public are kept to a minimum and shall not exceed the annual effective
equivalent dose limits of 20 mSv and 1.0 mSv respectively.
The doors of an x-ray room shall provide the same shielding as that of adjacent walls.
Appropriate shielding must be provided for dark room to ensure that underdeveloped x-ray
films stored in it will not be exposed to radiation.
Thickness equivalent to 2.0 mm lead ( 15 cm of concrete or 25 cm of brick walls (about 9)

with plaster will provide adequate protection outside the x-ray room against both primary and
secondary radiation in most of the diagnostic x-ray installation.
Unshielded openings, if provided in an x-ray room for ventilation/exhaust or natural light, must
be located at a height of not less than 2.0 m from the finished floor level /ground outside the xray room.
For diagnostic x-ray equipment operating below 125 kV, control panel should be located away
from the primary beam inside a stationery /mobile protective barrier. The protective barrier
should have sufficient lead equivalence (1.5 mm). For equipment operating at 125 kV or
above, the control panel must be installed in a separate control room located outside but
contiguous to the x-ray room and provided with appropriate shielding, direct viewing window
(1.5 mm lead equivalence) and oral communication facilities between the operator and the
patient.
In order to avoid the crowding of patients and relatives near the entrance door , a waiting area
must be provided outside and adjacent to the x-ray room.
A suitable warning signal such as a red light must be provided at a conspicuous place outside
the x-ray room and kept ON when the x-ray equipment is energized in order to prevent
inadvertent entry of persons not connected with the examination into the diagnostic room. An
appropriate warning poster also should be displayed outside the diagnostic room.
There shall be qualified and trained personnel in radiation safety deployed for the work.
Light Beam Diaphragm (LBD) must be functional.
Pregnant patients shall be well shielded and are subjected to radiation only if it is most
important.
Evacuation procedures, including a plan of the site showing the location of safety equipments
and fire extinguishers;
Anaesthetic coverage during procedure involving IV contrast media use;
Provision for radiation monitoring through DRP/BARC
Fluoroscopy
Fluoroscopy examinations should be done under image intensifier system. However, in case of
use of conventional fluoroscopy system (i.e without image intensifier), the room design should
be such that adequate darkness is achieved conveniently, when desired in the room.
A suitable red light should be provided in the room for the use of radiologist after dark
adaptation.
Alogofscreeningtimesforallfluoroscopicexaminationsmustbekept.
Ultrasound
Registration of clinic is mandatory along with details of machine and radiologists.
In case of portable machine there shall be registration of the vehicle.
Registration Certificate must be displayed in waiting area and examination room.
Signages in local & english language shall be displayed, indicating that fetal sex is not
disclosed in the clinic.
Form F must be filled in completely before the USG is done
Form G shall be filled in case of invasive procedures.
They shall be submitted to AA on monthly basis and copy of the same with signature of AA
shall be preserved.
All copies of form F and G shall be preserved for atleast 2 years along with the copy of referral
letter from referring Physician.
PC-PNDT
Minimum acoustic output and exposure time
Provision for anaesthetic coverage during interventional procedures.
act
booklet
must
be
available
in
the
waiting
room.
75
Proper patient privacy
Female technician to assist.
Clean hygienic disposable towel or tissue papers
Mammography
Average glandular dose as determined by the dosimeter must not exceed 2mGys (200mrads) per view,
using the RMI-156 phantom or another of equivalent constitution.
CT scan
CT units needs license as the potential for exposure is higher as compared to conventional
medical x-ray units.
Layout plan shall be approved by AERB
Installation shall be of type approved unit
There shall be Registration/license of unit with AERB
MIS shall ensure employment of only qualified staff
MIS shall provide personnel monitoring badges to radiation workers
They shall Carry out periodic quality assurance tests of CT machine
Radiation dosages shall be measured, managed, and then prescribed so that exposure from
radiation sources is as low as reasonably achieved (ALARA).
There shall be warning placard/ red light displayed outside the CT room.
Dose rate at the entrance door should be low.
Anaesthetic coverage during procedure involving IV contrast media use;
Provision for radiation monitoring through DRP/BARC
A CAT scan is not recommended for a pregnant woman.
Pre-entry safety check of all patients
MRI
76
Minimum exposure to different types of electromagnetic fields, radiofrequencies and any noise
An appropriately equipped emergency cart must be immediately available to treat serious

adverse reactions and for resuscitation in case of respiratory and cardiac arrest.
Patient shall wear loose, comfortable clothing, avoiding garments that have zippers, belts or
buttons made of metal. Objects such as keys or wallets that would be in the area being
scanned shall be removed.
Jewellery, eye glasses and any metal objects or clothing that might interfere with the x-ray
images shall be removed.
History of barium examination or injectable contrast material for a computed tomography (CT)
scan or radioisotope scan shall be obtained, and patient shall be advised to wait for 10 to 14
days before undergoing a DXA test.
History of pregnancy is taken and If an x-ray is necessary, precautions will be taken to

minimize radiation exposure to the baby
Facilities, in consultation with the Radiologist should have in place and should adhere to
policies and procedures, in accordance with ALARA, to vary examination protocols to take into
account patient body habitus, such as height and/or weight, body mass index, or lateral width.
The dose reduction devices that are available on imaging equipment should be active; if not,
manual techniques should be used to moderate the exposure while maintaining the necessary
diagnostic image quality.
Patient radiation doses should be periodically measured
Other safety measures as per AERB safety manual.
Nuclear medicine
Patient waiting areas shall be located and if necessary shielded, so that exposure from
radiation sources is as low as reasonably achieved (ALARA).
Person who may be exposed to radiation as a result of nuclear medicine procedure must be
advised of precaution they can take to minimise their radiation dose.
The quantity of radioactivity to be administered must be prescribed (either individually by

prescription or by protocol), assayed, and recorded.
The identity of the radiopharmaceutical and the patient, route of administration, and the
pregnancy and breast-feeding status of the patient shall be verified prior to administration.
Layout plan shall be approved by AERB
77
Installation shall be of type approved unit
There shall be Registration/license of unit with AERB
MIS shall ensure employment of only qualified staff
MIS shall provide personnel monitoring badges to radiation workers
Sufficient numbers of syringe shields and shielded containers must be available in good
condition and shall be used unless contraindicated for a specific patient.
Written instruction must be available, in particular for therapeutic procedures involving

potentially larger exposures.
Appropriate precautions regarding pregnant and breast feeding patient must be observed.
Including warning signs, verbal enquiry and the issue of special instructions to the patient
where required.
Written instructions must be available for patients undergoing nuclear medicine therapy.
There shall be appropriate procedures and resources for handling accidents involving
radioactive materials and for subsequent decontamination must be available.
Radiation monitoring equipment for the detection of contamination and radiation exposure level
must be available
Materials presenting a hazard of airborne transport shall be handled in fume hood.
There shall be provision of emergency eyewash clearly defined and appropriately labelled.
There shall be provision of appropriate labelling of all toxic, irritant, caustic and otherwise
hazardous substances.
There shall be appropriate clothing/equipments such as eye protection devices, impervious

aprons etc.
There shall be provision of flushing materials from the skin rapidly in the event of accidental
splashing.
There shall be developed guidelines for identification of patients not suitable for intravenous
sedation in absence of anaesthetist.
There shall be a documented procedure for management of likely mishaps (resuscitation).

Interventional Radiology
78
Cath Lab x-ray units needs license as the potential for exposure is higher as compared to
conventional medical x-ray units.
Surgical support shall be available, with its prerequisite ancillary services such as available in
an acute care hospital If this support is not available, there shall be provision of along with
formal detailed protocols for rapid transport to an appropriate acute care facility.
To be eligible to provide diagnostic imaging services under Medicare, sites with diagnostic
imaging equipment must register that equipment with Acts & Rules of Indian law Equipment to
be registered with Indian registration which is relevant to the accreditation standards includes
individual:
Ultrasound units and transducers;
Computed tomography units;
Angiography systems;
General X-ray equipment;
Fluoroscopy equipment;
Mammography equipment; and
To maintain registration, sites must annually confirm or update equipment information to the
relevant authority.
Staff/personnel safety
All the imaging centre personnel shall be informed of hazards including radiation hazards.
There shall be appropriate hand washing and hand drying facilities available:
Hand basins should not be fitted with domestic taps but with a suitable alternative (e.g. Elbow
or foot activated devices)
There shall be Single use towels or automatic hand drying facilities.
A suitable hand cleansing agent should be available.
Where warranted a safety shower should be available in close proximity to all staff and its operation
should be checked regularly.
Where warranted, eyewash solutions or eye wash stations should be available in close proximity to all
staff. If commercial eyewash preparations are used make sure that the solutions are within expiry date.
Other than General safety measures following specific safety measures shall be taken by personnel:
Radiology and Fluoroscopy
Registrants and licensees shall ensure that workers are provided with suitable and adequate
personal protective equipment.
Protective equipment includes lead aprons, thyroid protectors, protective eye-wear and gloves.
The need for these protective devices should be established by the RPO.
Use of suspended screen and other personal shielding tools available.
79
Collimate the X-ray beam to the area of interest
The room housing the x-ray equipment must be spacious enough to permit installation and
servicing of the equipment and operation of the equipment with safety and convenience for the
servicing personnel and operators.
Personnel monitoring badges shall be used.
Personnel monitoring badges shall be stored in a radiation free area.
Lead aprons shall be used by doctors/ technicians during fluoroscopic examinations
Additional filter provided in the X-ray tube shall be in place.
There shall be sufficient area for X-ray installation.
There shall be use protective equipment such as mobile protective barrier, lead rubber aprons,
gloves, thyroid shields etc.
Mammography
Female technician to carry out studies
Automatic processors
Ultrasound
Female technician to assist.
The dose reduction devices available on imaging equipment should be active
Patient radiation doses should be periodically measured in accordance with technical

standards
Nuclear medicine
80
The volume and radioactivity of the generator eluate must be measured and recorded. Care
must be taken to minimize exposure to personnel at all steps in setting up, eluting, and
assaying the elute;
Aseptic procedures must be followed whenever handling parenteral radiopharmaceutical

preparations or their components;
Labeling efficiency of kit-prepared technetium-99m radiopharmaceuticals should be evaluated

periodically, such as the first vial of a new lot. Specifically, testing for free pertechnetate and
hydrolyzed-reduced radiochemical impurities should be performed. Radiopharmaceuticals
should not be administered if the total level of radiochemical impurities exceeds 10%.
Under no circumstances may pipetting of any materials by mouth be permitted.
Personnel who routinely handle radionuclides must be monitored for radiation exposure.
Provide reading material to patients to reduce apprehensions.
MRI
CT scan
Radiation monitoring devices for all technical and staff through DRP/BARC
MIS shall ensure that for the Cath Lab x-ray installations procurement is of type approved xray unit and construction of the room as per the approved layout plan.
There shall be adequate staff, monitoring equipment including personnel monitoring facilities
and availability of personal protective equipment such as lead apron, lead protective barriers
etc.
RCS2
Medical Imaging service ensures that the risk of infection to staff, patient and
others is identified, assessed, managed and minimised.
The Medical Imaging service shall ensure that the risk of infection is minimised by providing
appropriate training and equipments and upholding rigorous standard of hygiene.
Policies and procedures for all infection control issue including sterilisation/disinfection must be
documented and comply with the state legislation.
The medical imaging centre shall follow Universal precautions for infection Control and Use of PPE
Personal Protective Equipment.
There shall be defined policies and protocols to manage the risk of infection with specific reference to
immune suppressed patients or patients with communicable diseases.
81
There shall be defined policies and protocols for decontamination of equipment and environment
following an incident.
Cleaninganddisinfectionincludinginfectioncontrolprocedures;
All the imaging centre personnel shall be informed of hazards to infection like needle stick injury, eye
contamination etc. and they shall immediately be reported, investigated, recorded and analysed with
finding disseminated, communicated to all relevant authority and acted upon. Post exposure
prophylaxis shall be used as per guidelines of regulatory authority.
Immunisation status of each staff should be requested and records kept. Immunization against
Hepatitis B infection should be implemented after appropriate tests.
Hand basins should not be fitted with domestic taps but with a suitable alternative (e.g.
Elbow or foot activated devices)
Radiologist, nurses and technicians shall have knowledge of infection process and application of
infection control principles.
Along with general requirements, centre shall also follow following methods:
Radiology
Multidose vials of contrast media
Washed, clean linen shall be provided;
Sterilised instruments, syringes and catheter shall be used for procedures like HSG,MCU,RGU etc.;
The use of multidose contrast media is acceptable if the following procedures are used :
Withdrawal of contrast under strict aseptic conditions;
Use of new needle and syringe for re-entering vials even for the same patients use;
Discarding of any contrast medium not used after 4 hours.
Ultrasound
Disinfection of endocavitatory ultrasound transducers
Use of double protective shield before insertion of endocavitatory probe
Practices shall comply with the equipment manuals and State guidelines for Disinfection of
82
transvaginal transducers
There shall be availability of clean linen, disposable consumables and sterilised instruments.
Mammography
There shall be provision of washed clean linens.
CT scan
There shall be provision for sterilised instrument, disposable syringes and needle and catheter;
There shall be provision of washed clean linens.
RCS3 Medical Imaging service ensures that the risk associated with
The medical imaging services shall ensure to minimise the potential of harm from hazardous
substances and materials by providing appropriate training and equipment.
There shall be procedure and policy for storage of hazardous chemicals and substances, where
warranted, a flammable liquids storage cabinet is recommended for all but small volume;
There shall be procedures and policies for management of spill of hazardous materials by trained
personnel.
There shall be documented policies and procedures for the safe disposal of contaminated/medical
waste which must be in accordance with relevant regulations. Waste disposal methods shall comply
with Atomic Energy (safe disposal of radioactive wastes) rules, 1987.
All the imaging centre personnel shall be informed of bio medical hazards and if incident occurs they
shall immediately be reported, investigated, recorded and analysed with finding disseminated,
communicated to all relevant authority and acted upon. Post exposure prophylaxis shall be used as per
guidelines of regulatory authority. There shall be preset policies and procedures for decontamination of
equipment and environment following an incident.
There shall be procedures for cleaning and disinfection of work areas depending on the
microorganisms and other agents encountered. Most commonly used reagents for such purpose
includes hypochlorite, alcohol and phenols.
All the imaging centre personnel shall be informed of hazards including radiation hazards.
83
Hand basins should not be fitted with domestic taps but with a suitable alternative (e.g. Elbow
or foot activated devices)
Where warranted, eyewash solutions or eye wash stations should be available in close proximity to all
staff. If commercial eyewash preparations are used make sure that the solutions are within expiry date.
Other than General safety measures following specific safety measures shall be taken by personnel:
Radiology and Fluoroscopy

Additional filter provided in the X-ray tube shall be in place.
There shall be sufficient area for X-ray installation.
There shall be use protective equipment such as mobile protective barrier, lead rubber aprons, gloves,
thyroid shields etc.
Mammography
Female technician to carry out studies
Automatic processors
Ultrasound

The dose reduction devices available on imaging equipment should be active
Patient radiation doses should be periodically measured in accordance with technical standards
84
MRI
Provide reading material to patients to reduce apprehensions.
CT scan
Radiation monitoring devices for all technical and staff through DRP/BARC
RCS4 Medical Imaging service ensures that the risk of violence and
aggression to staff,
patient and others are identified, assessed,
The medical imaging services shall ensure that enough security personnel shall be available for
assistance whenever act of violence or regression is encountered.
The MIS shall ensure that incidents of violence and regression are reported, investigated, recorded
and analysed with findings disseminated, communicated to all relevant parties and are acted upon.
RCS5 Medical Imaging service ensures that the risk associated with fire,
electrocution and other disaster to staff, patient and others and to facility
and environment are identified, assessed, managed and minimised.
The medical imaging services shall ensure to promote good health and safety culture, manage
adverse healthcare events and minimise risk and failure, including risk of fire.
Practices in medical imaging centre shall ensure fire safety issues along with other relevant statutory
requirements are in place:
There shall be appropriate fire extinguishing devices;
There shall be installation of fire alarm and smoke/fire detector;
There shall be proper display of radiation and safety signs and boards like (1)signs of
identification of safety equipments such as fire extinguishers, showers, eyewash facilities,
(2) signs to identify hazards and hazardous activities, (3) signs to delineate public areas
from area of restricted access.;
Evacuation procedures, including a plan of the site showing the location of safety
equipments and fire extinguishers;
Spill kits shall be available for acids and solvents;
There shall be biological safety cabinet for handling of fresh human specimen
85
Corridors should not be used as general storage areas and evacuation routes must always
be kept clear.
Section 3
86
(Annexure 1)
List of Licenses and Statutory Obligations
All of them might not be applicable to all the MIS:
1.
Building Permit (From the Municipality).
2.
No objection certificate from the Chief Fire officer.
3.
License under Bio- medical Management and handling Rules, 1998.
4.
No objection certificate under Pollution Control Act.
5.
Radiation Protection Certificate in respect of all X-ray and CT Scanners from BARC.
6.
Excise permit to store Spirit.
7.
Income tax PAN.
8.
Permit to operate lifts under the Lifts and escalators Act.
9.
Narcotics and Psychotropic substances Act and License.
10.
Sales Tax Registration certificate.
11.
Vehicle registration certificates for Ambulances.
12.
Retail drug license (Pharmacy).
87
13.
Wireless operation certificate from Indian post and telegraphs. (if applicable)
14.
Air (prevention and control of pollution) Act, 1981 and License
15.
Arms Act, 1950. (if guards have weapons)
16.
Atomic energy regulatory body approvals.
17.
Biomedical waste management handling rules 1998.
18.
Boilers Act1923.
19.
Cable television networks Act 1995.
20.
Central sales tax Act, 1956.
21.
Consumer protection Act, 1986.
22.
Contract Act, 1982.
23.
Copyright Act, 1982.
24.
Customs Act, 1962.
25.
Dentist regulations, 1976.
26.
Drugs & cosmetics Act, 1940.
27.
Electricity Act, 1998.
28.
Electricity rules, 1956.
29.
Employees provident fund Act, 1952.
30.
ESI Act, 1948.
31.
Employment exchange Act, 1969.
32.
33.
Environment protection Act, 1986.

Equal remuneration Act, 1976.
34.
Explosives Act1884.
35.
Fatal accidents Act1855.
36.
Gift tax Act, 1958.
37.
Hire Purchase Act, 1972.
38.
Income Tax Act, 1961.
39.
Indian Lunacy Act, 1912.
40.
Indian medical council Act and code of medical ethics, 1956.
41.
Indian Nursing council Act1947.
42.
Indian penal code, 1860.
43.
Indian trade unions Act, 1926.
44.
Industrial disputes Act, 1947.
45.
Insecticides Act, 1968.
46.
Lepers Act
47.
Maternity benefit Act, 1961.
48.
MTP Act, 1971.
49.
Minimum wages Act, 1948.
50.
National building code.
51.
National holidays under shops Act.
52.
Negotiable instruments Act, 1881.
53.
Payment of bonus Act, 1965.
88
54.
Payment of gratuity Act, 1972.
55.
Payment of wages Act, 1936.
56.
Persons with disability Act, 1995.
57.
Pharmacy Act, 1948.
58.
PNDT Act, 1996.
59.
Prevention of food adulteration Act, 1954.
60.
Protection of human rights Act, 1993.
61.
PPF Act, 1968.
62.
BARC, Act.
63.
Registration of births and deaths Act, 1969.
64.
Sale of goods Act, 1930.
65.
Tax deducted at source Act.
66.
Sales tax Act.
67.
68.
SC and ST Act, 1989

License for the blood bank
69.
Companies Act, 1956
70.
Constitution of India
71.
Insurance Act, 1938
72.
Transplantation of human organs Act 1994 and License (if applicable)
73.
Workers compensation Act, 1923
74.
Urban land Act, 1976
(Annexure 2)
Chapter 4 - REGULATION & CERTIFICATION FOR MEDICAL

X-RAY
LegislationinIndia:
AtomicEnergyAct,1962isthebasicNuclearLegislationwhichprovidesforframingofrulesfor
ensuringsafetyintheuseofionisingradiationinIndia.TheAtomicEnergy(RadiationProtection)Rules,
2004whichisarevisedversionoftheRadiationProtectionRules,1971,issuedundertheActspecify,inter
alia,therequirementsrelatingto
89
licensingorauthorisation,orregistration[powertorevokeormodifyorwithdrawthelicences]
dutiesofRadiologicalSafetyOfficers,theirqualifications
radiationsurveillanceprocedurestobeissuedbytheCompetentAuthority
powersofCompetentAuthorityregardinginspectionofradiationinstallations,sealingandseizure
ofdevicescontainingradioactivematerialandresponsibilitiesofthelicensee.
Chairman, Atomic Energy Regulatory Board (AERB) is the Competent Authority for the
purposeofimplementationoftherules.SurveillanceProceduresareissuedundertheRules,bythe
CompetentAuthorityforvariousradiationinstallations.
AtomicEnergyRegulatoryBoard
The Atomic Energy Regulatory Board has eminent individuals and senior government
functionariesasitsmembers.TheChairmanoftheBoardheadstheexecutivewingofAERBwhichhas
a large team of scientists and engineers with knowledge and experience in the field of radiation
safetyinnuclearandradiationfacilities.AERBisfinanciallyandadministrativelyindependentofthe
nuclear industry and does not participate in the promotion of the applications of radiation in any
field. The Board has constituted expert committees on various aspects of radiation safety for
continuousmonitoringofsafeoperationofnuclearfacilitiesandradiationfacilities.Expertsfromall
overthecountryfromgovernmentalandprivateinstitutionsareincludedinthesecommittees.The
recommendations of the committees are forwarded to the Chairman, AERB for consideration for
implementation.Mattersoffundamentalimportancearereferredtotheapexbody,viz.,theBoard.
Mission of AERB: The mission of AERB is to ensure that the use of ionizing radiation and nuclear
energyinIndiadoesnotcauseunduerisktohealthandenvironment.
Functions of AERB: The basic function of AERB is to enforce rules and regulations issued under the
AtomicEnergyAct,1962forradiationsafetyinthecountry.ItalsoenforcesrulesundertheFactories
Act, 1948 for industrial safety in the units under the control of the Department of Atomic Energy
(DAE).DetailedfunctionsofofAERBarelistedbelow:
90
Ensure compliance by DAE and nonDAE installations with the safety codes, guides and
standards.
Reviewoperationalexperienceinthelightoftheradiologicalandothersafetycriteria.
Review applications for authorization, commissioning and operation of DAE projects and
plants.
Prescribeacceptablelimitsof(a)radiationexposuretooccupationalworkersandmembersof
thepublicand(b)environmentalreleaseofradioactivesubstances.
Carry out safety research and promote safety research and development efforts at various
academicandresearchinstitutionsinIndia.
Prescribesyllabifortrainingofpersonnelinthesafetyaspectsatalllevels.
Maintain liaison with other regulatory bodies in India and other countries regarding safety
matters.
Keepthepublicinformedonmajorissuesofradiologicalsafetysignificance.
Reviewandinvestigatesafetyrelatedunusualoccurrencesinrespectofradiationgenerating
equipmentandradioactivematerialsinradiationandnuclearfacilities.
Inspectallnuclearandradiationinstallations.
Prescribestandardsforsafedisposalofradioactivewaste.
Maintaininventoryofallradioactivematerial.
Prescribesafetystandardsfortransportofradioactivematerial.
Safetypromotionalactivities.
IssuelicencetooperatingpersonnelinDAEfacilities.
Monitoremergencypreparednessinallnuclearandradiologicalfacilities.
91
Developsafetycodes,guidesandstandards.
Safety Codes and Guides are published by AERB relating to applications of radiation in
industry, medicine and research and transport of radioactive materials. The Codes and Guides
prescribe the regulatory requirements relating to radiation installations including layout, radiation
handlingequipment,areaandindividualmonitorsandqualificationofpersonnel.SafetyStandardsfor
sources and a variety of devices incorporating radioactive sources have been issued by AERB. The
provisionsoftheCodes,GuidesandStandardsareenforcedbyAERB.
Regulatory Licence
Every institution or person handling radioactive source has to obtain regulatory licence,
i.e. licence or authorization or registration from the Competent Authority. The pre-requisites for
authorization include
Typeapprovedequipment
Approvedfacilityandinstallation
Radiation(area/individual)monitoringdevices
Qualified,TrainedandCertifiedmanpower
Emergencyresponseplans
Duringtheuseofradiationsources,specificpriorapprovaloftheCompetentAuthorityisrequiredin
respectofeverysourcereplacement,sale,transfer,transport,exportanddisposal.
Regulatorycontrolinthreestages:
92
Prelicensing : The unit should be typeapproved, the layout of the installation should satisfy the
normsprescribedintheAERBCode,workersshouldbequalifiedasprescribedintheAERBCodeand
regularlymonitored.
During use: All licensees are required to use the xray installation as per the safety procedures in
accordance with the AERB safety code. Noncompliance is a violation. Defaulters can be penalised.
Regulatoryinspectionsareconductedasandwhennecessary..
Aftertheusefullifeofthesource:Uponcompletionoftheusefullifeoftheinstallation,thelicensee
decommissionstheinstallationandinformAERBaboutit.Theinstallationshouldbedecommissioned
inamannerthatitshouldbenotbepossibletoassemblethepartsagainandenergizethexrayunit.
Premarketingapproval:
All models of x-ray equipment used in medical applications, viz., X-ray tubes are
assessed for their compliance with the safety standards prescribed by AERB for design and
operation; imported equipment satisfying IEC standards are accepted. Measurement of
radiation levels and the design features of the device are examined by independent experts.
All requests for type approval are examined by the Safety Review Committee for
Applications of Radiation (SARCAR) which is constituted by the Chairman, AERB. The
members of SARCAR include experts on radiation safety drawn from the Department of
Atomic Energy, an experienced radiologist, a radiotherapist, a representative of the Indian
Bureau of Standards and senior officers from AERB. AERB is thus able to ensure that the
safety norms are in complete conformity with the international standards and take into account
the requirements of the actual users.
Registrationandlicensing:
Regulatoryconsentforworkingwithradiationisissuedintheformofregistration,orlicence.
Theformofconsentisdecidedonthebasisoftheradiologicalhazardassociatedwiththepractice.
Registration:Theregulatoryconsentissuedtousersofradiationsourcesofrelativelylowradiological
hazard is in the form of registration, e.g. diagnostic Xray installations. Registration of over 40 000
93
installations has been completed. As for future users, suppliers of type approved Xray units are
requiredtoensurethattheusersobtainthenecessaryregistrationpriortothesupplyofXrayunits.
Licensing: CT and Cath Lab xray units needs license as the potential for exposure is higher as
comparedtoconventionalmedicalxrayunits..
Issuance of regulatory consent is always preceded by a thorough assessment of the

protection facilities, expertise, equipment and monitoring devices available with the prospective
consentee.Approvalofthelayoutoftheradiationinstallationisabasicprerequisiteinmostcases.
Regulatory consent is issued subject to terms and conditions which require compliance by the
consentee with the regulatory requirements prescribed in the rules, notifications, standards, codes
andguides.Contraventionofthesetermsandconditionscouldentailrevocationorsuspensionofthe
consent.Theconsenteecanappealagainstanorderrevokingaconsent.
AERBSafetyCodeforMedicalDiagnosticXrayEquipmentandInstallations
(AERB/SC/MED2)
Thesafetycodedealswith:
1. SafetyspecificationsformedicaldiagnosticXrayequipmentandprotectivedevices
(Xraytubehousingleakageshouldnotexceed115mRinhourat1Mfromthetarget,Tube
filterationupto70kV:1.5mmAl,70100kV:2.0mmAlandabove100kV:2.5mmAl,Dental
cones5060kV:10cm,6075kV:20cm,above75kV:30cmetc.)
2. RoomLayoutforanXrayinstallation
(generalpurposeradiographyincludingfluoroscopy18sq.metersandCTandCathlabunits25
sq.meters,wallsshouldbeminimumof23cmofbrick,doorsareleadlined,preferablysingle
entry)
3. Radiationprotectionandworkpractice
(Crowdingofpatientsshouldbeavoided,assistancetopatientsduringxrayexposurebyrelatives
andnotbytheoperator,useofprotectivedevices)
4. Personnelrequirementsandresponsibilities
(Qualifiedradiographer,radiologist,serviceengineer)
ResponsibilitiesoftheowneroftheXrayunit:
94
a.
b.
c.
d.
e.
f.
g.
GetthelayoutplanapprovedbyAERB
Installingtypeapprovedunit
Registration/licenseofunitwithAERB
Employqualifiedstaff
Providepersonnelmonitoringbadgestoradiationworkers
CarryingoutperiodicqualityassurancetestsofXrayunits
Complywithalltherelevantrulesandregulations
ResponsibilityoftheManufacturer/suppliersofXrayunits:
a. InstallonlytypeapprovedunitsonlyaftertheplanisapprovedbyAERB
b. ConducttheperformancetestoftheXrayunitpriortohandingovertotheuser
c. Giveacopyoftheperformancetestreporttouserforrecords
Regulatoryinspections
Experience has shown that regulatory inspections contribute substantially to the effective
implementation of radiation protection requirements. Of particular significance are unannounced
inspections. Periodic inspections are conducted on the basis of the potential radiological hazard
associatedwithapractice.
QualityAssurance
The annual average individual occupational exposure in diagnostic radiology in India

is 0.45 mSv. It is observed that the most important component of radiological safety in
diagnostic X-ray installations is Quality Assurance of the X-ray units. The highest importance
is accorded to quality assurance of X-ray units. A series of training programmes for radiation
safety professional in the country is conducted and it is ensured that the necessary QA kits are
made available to them.
(ANNEXURE3)
GLOSSARYOFTERMS
Adult. An individual who has capacity and is at least 18 years of age.
95
96
Calibration is a set of operations which establish, under specified conditions, the relationship between values indicated
by a measuring instrument or measuring system, or values represented by a material measure, and the corresponding
known values of a measured.
Capacity. An individuals ability to understand the significant benefits, risks, and alternatives to proposed health care
and to make and communicate a health care decision. These regulations do not affect the right of a patient to make
health care decisions while having the capacity to do so. A patient shall be presumed to have capacity to make a
health care decision, to give or revoke an advance directive, and to designate or disqualify a surrogate. Any person
who challenges the capacity of a patient shall have the burden of proving lack of capacity.
Cardiopulmonary Resuscitation (CPR). The administering of any means or device to support cardiopulmonary
functions in a patient, whether by mechanical devices, chest compressions, mouthtomouth resuscitation, cardiac
massage, tracheal intubation, manual or mechanical ventilators or respirators, defibrillation, the administration of drugs
and/or chemical agents intended to restore cardiac and/or respiratory functions in a patient where cardiac or
respiratory arrest has occurred or is believed to be imminent.
Certified Registered Nurse. A registered nurse currently licensed by the Nursing council.
Check is a measurement of at least one point in a range of a measuring instrument or system or material against a
known value to confirm that it has not deviated significantly from its original calibrated value. It is also an examination
of a condition of an artefact to determine that it has not been adversely affected by constant use.
Competent. A patient who has capacity.
Computerized Tomography. A non-invasive radiological diagnostic procedure that may or may not include nuclear
medical dye.
Designated/referring Physician. A physician designated by an individual or the individuals agent, guardian, or
surrogate, to have primary responsibility for the individuals health care or, in the absence of a designation or if the
designated physician is not reasonably available, a physician who undertakes such responsibility.
Document. Document is any information or instruction including policy statement, text books, procedure,
specifications, calibration tables, posters, charts, notices, drawings, plans and document of external origins like
regulations, standards or examination procedures.
Guardian. A judicially appointed guardian or conservator having authority to make a health care decision for an
individual.
Hazardous Waste. Materials whose handling, use, storage and disposal are governed by local, state or federal
regulations.
Health Care. Any care, treatment, service or procedure to maintain, diagnose, treat, or otherwise affect an individuals
physical or mental condition, and includes medical care as defined in T.C.A. 32-11-103(5).
Health Care Decision. Consent, refusal of consent or withdrawal of consent to health care.
Health Care Decision-maker. In the case of a patient who lacks capacity, the patients health care decision-maker is
one of the following: the patients health care agent as specified in an advance directive, the patients court-appointed
guardian or conservator with health care decision-making authority, the patients surrogate as determined pursuant to
Rule 1200-8-35-.13 or T.C.A. 33-3-220, the designated physician pursuant to these Rules or in the case of a minor
child, the person having custody or legal guardianship.
Health Care Provider. A person who is licensed, certified or otherwise authorized or permitted by the laws of this state
to administer health care in the ordinary course of business or practice of a profession.
Incompetent. A patient who has been adjudicated incompetent by a court of competent jurisdiction and has not been
restored to legal capacity.
Infectious Waste. Solid or liquid wastes which contain pathogens with sufficient virulence and quantity such that
exposure to the waste by a susceptible host could result in an infectious disease.
Licensee. The person or entity to whom the license is issued. The licensee is held responsible for compliance with all
applicable rules.
Lithotripsy. A technique using extracorporeal shock waves to break up stones that form in the kidney, bladder, ureters,
or gallbladder while monitoring through x-ray or ultrasound.
Magnetic Resonance Imaging (MRI). A non-invasive diagnostic technique that produces computerized images of
internal body tissues and is based on nuclear magnetic resonance of atoms within the body induced by the application
of radio waves.
Mammography. A non-invasive radiological procedure used to take pictures of the breasts in order to diagnose tumors
or cysts.
Medical Emergency. A medical condition manifesting itself by acute symptoms of sufficient severity (including severe
pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the
patients health in serious jeopardy, serious impairment to bodily functions or serious dysfunction of any bodily organ
or part.
Medical Record. Medical histories, records, reports, summaries, diagnoses, prognoses, records of treatment and
medication ordered and given, entries, x-rays, radiology interpretations and other written electronics, or graphic data
prepared, kept, made or maintained in a facility that pertains to confinement or services rendered to patients admitted
or receiving care.
Medical Staff. An organized body composed of individuals appointed by the Outpatient Diagnostic Centre governing
board. All members of the medical staff shall be licensed to practice in Tennessee, with the exception of interns and
residents.
Patient. Includes but is not limited to any person who is suffering from an acute or chronic illness or injury or who is
crippled, convalescent or infirm, or who is in need of obstetrical, surgical, medical, nursing or supervisory care.
Patient Abuse. Patient neglect, intentional infliction of pain, injury, or mental anguish. Patient abuse includes the
deprivation of services by a caretaker which are necessary to maintain the health and welfare of a patient or resident;
however, the withholding of authorization for or provision of medical care to any terminally ill person who has executed
an irrevocable living will in accordance with the Tennessee Right to Natural Death Law, or other applicable state law, if
the provision of such medical care would conflict with the terms of such living will shall not be deemed patient abuse
for purposes of these rules.
PCPNDT Act: Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Rules, 1996, 2003.
Percutaneous Transluminal Coronary Angioplasty. An invasive diagnostic procedure in which a transluminal catheter
is guided through the femoral, subclavian, internal jugular or antecubital vein allowing the passage of a balloon-tipped
catheter distally into the coronary artery while viewing through radiological pictures. The balloon is aligned within the
stenosis and inflated to dilate the vessel with or without the use of anticoagulants to reduce the incidence of
thrombosis at the site of balloon dilation and calcium blockers or nitrates to reduce coronary spasm. Conscious
sedation and local anaesthesia at catheter insertion site are utilized during the procedure.
Positron Emission Tomography (PET scan). A non-invasive radiological procedure producing a sectional view of the
body constructed by positron-emission tomography.
Radiological Technologist. A person currently certified as such by the State registration Council as Radiological
Technologist. Registered Nurse (R.N.). A person currently licensed as such by the Nursing Council of India.
Shall or Must. Compliance is mandatory.
Surrogate. An individual, other than a patients agent or guardian, authorized to make a health care decision for the
patient.
Tier A procedures.
Tier B procedures.
Transfer. The movement of a patient at the direction of a physician or other qualified medical personnel when a
physician is not readily available but does not include such movement of a patient who leaves the facility against
medical advice.
Unusual Event Report. A report form designated by the department to be used for reporting an unusual event.
Ultrasound Form A:Form of Application For Registration or Renewal of Registration of A Genetic Counselling
Centre/Genetic Laboratory/Genetic Clinic/Ultrasound Clinic/Imaging Centre
Ultrasound Form B:Certificate of Registration
Ultrasound Form C:Form For Rejection of Application For Grant/Renewal of Registration
Ultrasound Form D:Form For Maintenance of Records By The Genetic Counselling Centre
Ultrasound Form E:Form For Maintenance of Records By Genetic Laboratory
Ultrasound Form F:Form For Maintenance of Record In Respect of Pregnant Woman By Genetic Clinic/Ultrasound
Clinic/Imaging Centre
Ultrasound Form G:Form of Consent
Ultrasound Form H:Form For Maintenance of Permanent Record of Applications For Grant/Rejection of Registration
Under The Pre-Natal Diagnostic Techniques (Regulation And Prevention Of Misuse) Act, 1994.
Vascular Embolization. Therapeutic introduction of various substances into the circulation to occlude vessels, either to
arrest or prevent haemorrhaging, to devitalize a structure, tumour or organ by occluding its blood supply or to reduce
blood flow to an arteriovenous malformation.
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FOREWORD

Introduction to Medical Imaging Services

Control of Services (CS)

Control of Processes and Procedures (CPP)

Control of Facility and Environment (CFE)

Control of Personnel (CP)

Control of Equipment (CE)

Control of Documents and Record (CDR)

Risk control and Safety (RCS)

Control of Services (CS)

Control of Processes and Procedures (CPP)

Control of Facility and Environment (CFE)

Control of Personnel (CP)

Control of Equipment (CE)

Control of Documents and Record (CDR)

Risk control and Safety (RCS)

Section three comprises of Annexure

Bone mineral Densitometry

Dual Energy X Ray Absorptiometry (DEXA)

Magnetic Resonance Imaging

General Nuclear Medicine

Radio frequency ablation(RFA)

Medical Imaging service ensures quality of interventional procedures

Medical Imaging service ensures proper management of facility

Medical Imaging service ensures proper management of environment of the facility.

Medical Imaging service ensures authorization, management and support to staff to

Medical Imaging Service ensures appropriate procurement and installation of the

Medical Imaging Service ensures appropriate operation and working of the

Medical Imaging Service ensures appropriate maintenance and repair of the

Medical Imaging Service ensures appropriate replacement of existing equipment &

Medical Imaging Service ensures generation, completion, revision, retention and

Medical Imaging Service ensures procurement and maintenance of documents of

Medical Imaging Services ensures maintenance and updating of personnel data

Medical Imaging Services ensures maintenance and updating of all equipment

Medical Imaging Services ensures maintenance of medical imaging reports and

Medical Imaging Services ensures maintenance, integration, safety, confidentiality

Medical Imaging Services shall address systems to ensure delivery of the

Medical Imaging service shall address systems to ensure delivery of the

Roles and responsibilities of each area of service delivery are defined.

MIS ensure justification, scheduling and prioritisation of referrals according to patient

MIS ensure that alternative imaging pathways are offered if considered in

Medical Imaging service ensures that delivery of services is patientfocused.

MIS ensure that the information about specific examination/procedure is available to

MIS ensure continuity of care of patients in collaboration with the referrer.

Medical Imaging service ensures the acquisition of optimal diagnostic

Medical Imaging service ensure the quality (clinical and technical) of

Medical Imaging service ensures quality of interventional procedures

Medical Imaging service shall ensures proper management of drugs and

MIS assure quality of diagnostic images

MIS ensure communication of reports to primary and secondary clients within

MIS ensure coordination between relevant teams/departments/organizations

Medical Imaging service ensures proper management of facility.

Medical Imaging service ensures proper management of environment of

Medical Imaging service ensures authorization, management and

Medical Imaging service ensures that the staff is competent to deliver

Medical Imaging service ensures service and workforce review,

Medical Imaging service ensures authorization, management and

MIS ensures that staff are able to comment/feedback in confidence regarding

Medical Imaging service ensures service and workforce review,

Medical Imaging service manages and monitors appropriate

Medical Imaging service manages and monitors appropriate operation

Medical Imaging service manages and monitors appropriate

Medical Imaging service manages and monitors appropriate