Standards For MIS - 2nd Edition - Edited

©National Accreditation Board for Hospitals and Healthcare Providers

QUALITY : SAFETY : WELLNESS

PREFACE TO THE RE-PRINT
National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent
board of Quality Council of India, established in 2005, is in its 15th year of creating an
ecosystem of quality in healthcare in India. NABH standards focus on patient safety and
quality of the delivery of services by the hospitals in the changing healthcare environment.
Without being prescriptive, the objective elements remain informative and guide the
organisation in conducting its operations with a focus on patient safety.

All NABH standards have been developed in consultation with various stakeholders in the
healthcare industry and if implemented help the healthcare organizations in stepwise
progression to mature quality systems covering the entire spectrum of patient safety and
healthcare delivery.
The NABH organization & the hospital accreditation standards are internationally recognized
and benchmarked. NABH is an Institutional as well as a Board member of the International
Society for Quality in Health Care (lSQua( and Asian Society for Quality in Health Care
(ASQua) and a member of the Accreditation Council of International Society for Quality in
Health Care (ISQua)
Over the years, successive NABH standards have brought about not only paradigm shifts in
the hospitals’ approach towards delivering the healthcare services to the patients but have
equally sensitised the healthcare workers and patients towards their rights and
responsibilities.
In celebration of our 74th Independence Day, on 15th of August, 2020, we are pleased
to announce, that starting today, in an enhanced effort to connect with people, all
NABH standards, across programmes, will be available free of charge as
downloadable documents in PDF format on the NABH website www.nabh.co. (The
Printed copies of Standards and Guidebooks will continue to remain available for
purchase at a nominal price).
NABH also announces the enriched continuation of its "NABH Quality Connect-Learning
with NABH" initiative, connecting free monthly training classes, webinars and seminars. The
various topics that will be taken up will cover all aspects of patient safety, including: Key
Performance Indicators, Hospital Infection Control, Management of Medication, Document
Control etc.
Recently introduced communication initiatives like Dynamic Website Resource Center and
NABH Newsletter Quality Connect (focusing on sharing the best quality practices, news
and views) will also be bettered.
It is sincerely hoped that all stakeholders will certainly benefit from the collective efforts of
the Board and practical suggestions of thousands of Quality Champions form India and
abroad
NABH remains committed to ensuring healthy lives and promote wellbeing for all at
all ages (SDG-3-Target 2030), creating a culture of quality in healthcare and taking
Quality, Safety and Wellness to the Last Man in the Line.
Jai Hind
(Dr. Atul Mohan Kochhar)

CEO-NABH 15th August 2020
National Accreditation Board
for Hospitals and Healthcare
Providers (NABH)
Accreditation Standards for Medical Imaging Services

(2nd Edition)
December 2019

© All Rights Reserved
No part of this book may be reproduced or transmitted in any form without permission in
writing from the author.
2nd Edition December 2019

FOREWORD
MIS Standards, are meant for the standalone Medical Imaging centres / Medical Imaging
organizations, which have a desire to implement quality system to improve quality and
patient safety. These standards can be used by the organization to enter the realm of
systematic quality management across a healthcare organization.
The standards cover the vitals of quality and safety management, and would facilitate in
delivering high quality care.
I wish every success to the organization adopting these for implementation and
congratulate them on their spirit of quality and patient safety.
CEO – NABH

Table of Contents
S. No. Particulars Page No.
01. Access, Assessment and Patient Care (AAPC) 1-8
02. Imaging, Procedures and Interpretations (IPI) 9 - 16
03. Facility Management and Safety (FMS) 17 - 20
04. Equipment, Material and Medications ( EMM) 21 - 26
05. Human Resource Management (HRM) 27 - 30
06. Management Of Quality And Safety (MQS) 31 - 35
07. Information Management System (IMS) 36 - 39
08. Comparative Study: 1st Edition to 2nd Edition 40 - 54
09. Glossary 55 - 62
10. List of Licenses and Statutory Obligations 63 - 64

Chapter 1
Access, Assessment and

Patient Care (AAPC)
Intent of the chapter:
Patients are well informed of the imaging services that an organization provides. Only
those imaging procedure request which can be performed by the available resources and
expertise are accepted by the organization. There is a well-defined registration process
to ensure continuity of care. Information required for performance of appropriate imaging,
prioritization of scheduling and interpretation is readily available. The organization defines
the patient and family‘s rights and responsibilities. The staff is aware of these rights and
is trained to protect them. Patients are informed of their rights and educated about their
responsibilities. The organization promotes the privacy, dignity and security; and the
service delivery is patient focused. A documented process for obtaining patient consent
exists for informed decision making about their care. Patients and families have a right to
seek and get information and education about the procedures in a language and manner
that is understood by them. The organization is prepared to handle imaging emergencies.
The patient transportation is safe and secure. Faculties for handling life threatening
events are available. Safe anaesthesia and sedation practices are followed.
Access, Assessment and Patient Care (AAPC) 1

Summary of Standards
AAPC.1. The organization defines and displays the medical imaging

services that it provides.
AAPC.2. The organization has a well-defined registration and admission

process.
AAPC.3. The organization protects patient and family rights and informs
them about their responsibilities during care.
AAPC.4. The organization has a documented procedure for obtaining

informed consent from the patients to enable informed decision
making about their care.
AAPC.5. Emergency imaging services are guided by documented policies,

procedures and the applicable laws and regulations.
AAPC.6. Patient transportation and ambulance services are guided by

documented policies, procedures, applicable laws and regulations.
AAPC.7. Documented policies and procedures guide the care of patients

requiring emergency intervention in case of any life threatening
event or cardio-pulmonary resuscitation.

undergoing anaesthesia and moderate sedation.
*This implies that this objective element requires documentation.

Standards and Objective Elements
Standard
AAPC.1. The organization defines and displays the medical imaging services
that it provides.
Objective Elements
a. The Scope of Medical Imaging Services being provided are clearly defined
and prominently displayed.*
b. Patients are accepted only if the organization can provide the required
Medical Imaging Service.
c. The staff are oriented to these services.*
Standard
AAPC.2. The organization has a well-defined registration and admission

process.
Objective Elements
a. Documented policies and procedures are in place for registering the patient
and a unique identification number is generated for each patient at the end
of registration.*
b. All attempts are made to ensure that the unique identification number is
maintained for each patient on all subsequent visits.*
c. There is a system in place to capture all the required information about the
procedure requested, the relevant clinical and lab details and information
about prior imaging and this information is readily available to all the staff
involved in patient care for verification prior to performing the procedure.

d. The organization has a process in place to ensure that the imaging is
appropriate for the patient and the clinical indication.*
e. There is a system in place for appropriate scheduling and prioritization

according to patient’s condition and urgency of diagnosis.*
f. The staff are oriented to these.
Standard
AAPC.3. The organization protects patient and family rights and informs them
about their responsibilities during care.
Objective Elements
a. Patients and families are informed of their rights and responsibilities in a

format and language that they can understand.*
b. The information about specific procedure is available to patients and

accompanying persons in relevant format and languages including the local
language.
c. The expected cost is informed prior to imaging.
d. Imaging services provided are uniform for a given health problem in all
settings.
e. The privacy and dignity of the patient is preserved without any

discrimination.
f. Confidentiality of patient information will be maintained.*
g. Patient and family have a right to seek an additional opinion.
h. The staff are aware and oriented to these.

Standard
AAPC.4. The organization has a documented procedure for obtaining informed

consent from the patients to enable informed decision making about
their care.
Objective Elements
a. Documented policy incorporates the list of situations where informed

consent is required and the process for taking informed consent.*
b. Informed consent includes information regarding the procedure, it’s risks,

benefits, alternatives in a language that they can understand.
c. The procedure describes who can give consent when patient is incapable
of independent decision making.*
d. Informed consent is taken by the person performing the procedure or by a

staff member of his team.
e. The staff are aware and oriented to these.
Standard
AAPC.5. Emergency imaging services are guided by documented policies,

procedures and the applicable laws and regulations.
Objective Elements
a. The organization shall have a process of identification of emergencies.*
b. Documented policies and procedures guide the triaging of patients for

prioritization of imaging.*
c. Documented protocols guide the handling of emergency patients in the

premises and during imaging.

d. Documented protocols guide the handling and management of medico-
legal cases.*
e. There is an identified area in the organization to receive and manage

emergency patients.
f. Staff are appropriately trained to manage these.
Standard
AAPC.6. Patient transportation and ambulance services are guided by

documented policies, procedures, applicable laws and regulations.
Objective Elements
a. Documented policies and procedures exist to ensure safe and timely

transportation of patient within, to and from the imaging services.*
b. There is adequate access and space for the ambulance(s) and/or patient
transport vehicle(s).
c. The ambulance and/or patient transport vehicle(s) adheres to statutory

requirements and are manned by trained personnel as per the existing laws
and regulations.
d. The ambulance(s) and/or patient transport vehicle(s) is appropriately

equipped.

Standard

requiring emergency intervention in case of any life threatening event
or cardio-pulmonary resuscitation.
Objective Elements
a. Documented policies and procedures guide the uniform use of resuscitation

throughout the organisation.*
b. Staff providing direct patient care are trained and periodically updated in
emergency life support and cardio-pulmonary resuscitation.
c. An appropriately equipped crash cart or a resuscitation tray is maintained.
d. The events during any emergency life support and cardiopulmonary

resuscitation are analysed.
e. There is a system in place for the transfer of patients to an appropriate acute

care facility when required.
Standard

undergoing anaesthesia and moderate sedation.
Objective Elements
a. Informed consent for administration of anaesthesia, mild and moderate

sedation is obtained.*
b. Competent and trained persons administer anaesthesia and sedation.*
c. The patient is appropriately monitored on predefined parameters before,

during and after the procedure till the discharge.

d. The equipment required for this is available.
e. The type of anaesthesia and anaesthetic medications used are documented

in the patient record.
f. Adverse Sedation/anaesthesia events are recorded and monitored.

Chapter 2
Imaging, Procedures and

Interpretations (IPI)
All images are acquired in accordance with agreed protocols by competent staff working
within their defined scope of practice. Images are of optimal diagnostic quality according
to current best practices. The Imaging studies are interpreted onsite as well as
Teleradiology using agreed format and language developed by competent staff working
within their defined scope of practice to deliver accurate and effective radiological and
clinical interpretation of the images. The quality, accuracy, verification and amendments
of reports are within defined timeframe and in accordance with the defined protocols.
Interventional procedures are conducted in accordance with agreed protocols by
competent staff working within their defined scope of practice. Drugs, isotopes, contrast
media and radiopharmaceuticals are prescribed, prepared and administered safely to
reflect statutory requirements. Their storage should be appropriate and adverse reactions
should be dealt with efficiently and effectively. Risks and safety of the procedures are
managed. Radiation safety and ALARA principles are followed.
Imaging, Procedures and Interpretations (IPI) 9

IPI.1. The organization defines the process for acquisition of optimal

diagnostic quality images.
IPI.2. Documented policies and procedures guide the care of patients

undergoing Diagnostic and Therapeutic Interventional procedures.
IPI.3. Organization defines the content of the imaging reports and

discharge documents.
IPI.4. The organization defines the process of communication of the

imaging results and discharge documents.
IPI.5. The Teleradiology services address all issues pertaining to reporting

and communication.
IPI.6. Documented procedures and policies guide all Research activities

and Clinical Trials.
IPI.7. There is an established risk control and safety program in the

imaging services.

Standard
IPI.1. The organization defines the process for acquisition of optimal

diagnostic quality images.
Objective Elements
a. Appropriately qualified and trained personnel perform and interpret the imaging
studies.*
b. The protocols for image acquisition for all examination are developed based on
current best practices, documented and are available at the place of work.
c. The protocols are appropriate for the specific age, gender; clinical indications,
anatomical part and modality.
d. The protocol implementation is monitored, and protocol deviations are

documented.
e. The protocols include appropriate post processing, and quantification as

appropriate for the clinical indication.
f. The protocols for image acquisition for all examination are reviewed at a defined
periodicity for improvement and adaptation of the current best practices and
guidelines.
g. Documented procedures exist to prevent events like a wrong site, wrong side and
wrong procedure.*
h. Patients are appropriately assessed and monitored before, during and after the
procedure.
i. The quality of diagnostic images and completeness of the procedures is

monitored through a documented process.
j. Staff are appropriately oriented and trained for these.

Standard
IPI.2. Documented policies and procedures guide the care of patients

undergoing Diagnostic and Therapeutic Interventional procedures.
Objective Elements
a. Adequately qualified and trained staff members perform and assist the
procedures.*
b. The protocols for all diagnostic and therapeutic interventional procedures are
developed and documented.
c. Interventional procedure patients have a pre procedural assessment and a

provisional diagnosis documented prior to procedure.
d. An informed consent is obtained by a member of the team performing the

procedure prior to the procedure and same is documented.
e. Documented policies and procedures exist to prevent adverse events like wrong
site, wrong patient and wrong procedure or wrong indications.*
f. Radiation safety procedures are followed.
g. Infection control practices are followed.
h. Appropriate facilities, and equipment, appliances and instrumentations are

available in the procedure area.
i. Appropriate sedation/anaesthesia, clinical and emergency support is available

before, during and after the procedure.
j. A procedure note is documented prior to transfer out of patient from the facility.
k. The outcomes of diagnostic and therapeutic interventional procedures are

monitored.
l. Staff are appropriately oriented and trained for these.

Standard
IPI.3. Organization defines the content of the imaging reports and discharge
documents.
Objective Elements
a. Appropriately qualified and trained personnel interpret the imaging studies on

display systems appropriate for the studies and modalities.*
b. Imaging report and a discharge document is provided to the patients for each
procedure.
c. Results are reported in a standardized manner and the current best practices and
guidelines.
d. The document contains the patient’s name, gender, Date of Birth or Age, unique
identification number, and date of the procedure.
e. The document contains diagnosis or differential diagnosis, the procedure

performed, medication and sedation administered, details of any adverse event
and any other treatment given.
f. The report ensures that the current clinical indication for the imaging study is
addressed and all attempts to be made to collate with the previous imaging findings
as well as clinical correlation.
g. The document contains advice for any other further investigation, follow-up
imaging advice, medication and other instructions as appropriate in an
understandable manner.
h. There is a defined Standard Operating Procedure to address recall / amendment

of reports when required.*
i. Staff are appropriately oriented and trained for these.

Standard
IPI.4. The organization defines the process of communication of the

imaging results and discharge documents.
Objective Elements
a. A list of conditions requiring critical and urgent communication is defined.*
b. There is a documented policy on routine, urgent and critical imaging findings with
a defined turn around time for each of them.*
c. The reports are communicated to the patient and/or referrer within the
appropriately defined timeframe based on the clinical indication and urgency.
d. Imaging tests and/or reporting outsourced to other organization(s) follow the same
turn around time requirements.
e. There is a system in place to ensure that right report is communicated to the right
patient and right physician at the right time.
Standard
IPI.5. The Teleradiology services address all issues pertaining to reporting

and communication.
Objective Elements
a. The tele radiology services are provided under a documented agreement between
the provider and consumer of the services.*
b. All clinical, lab and prior imaging information is available to the tele radiology
services provider.
c. Appropriately qualified and trained personnel interpret the imaging studies.
d. Appropriate equipment is used for acquisition, communication, display and storage

of images.
e. Results are reported in a standardized manner consistent with the organizational

standards.

f. There is a defined Standard Operating Procedure to address recall/amendment of
reports when required.
g. Staff are appropriately oriented and trained for these.
Standard
IPI.6. Documented procedures and policies guide all Research activities

and Clinical Trials.
Objective Elements
a. Documented policies and procedures guide all research activities in compliance

with regulatory, national and international guidelines.*
b. The organization has access to an appropriate ethics committee or Internal Review

Board to oversee all research activities.*
c. The committee has the powers to discontinue a research trial when risks outweigh
the potential benefits.
d. Patient’s informed consent is obtained before entering them in research protocols

in accordance with the prevalent laws and regulations.
e. Patients are informed of their right to withdraw from the research at any stage and
also of the consequences (if any) of such withdrawal.
f. Staff are appropriately oriented and trained for these.
Standard
IPI.7. There is an established risk control and safety program in the Imaging
services.
Objective Elements
a. The radiation-safety program is documented and developed by the Radiation

Safety Committee of the organization and implements the principals of ALARA.*

b. This program is implemented and overseen by an appropriately designated
Radiation Safety Officer and is aligned with the organization's safety program.*
c. Radiation signages are prominently displayed in all appropriate locations.
d. Patients are appropriately screened for safety/risk prior to undergoing an imaging

on a particular modality.
e. Staff personnel and patients are provided with appropriate radiation protection
devices.
f. Personal radiation monitoring devices are provided to all the radiation workers.
g. The safety program also addresses the risk associated with MRI.
h. The safety program also addresses Ultrasound Services.
i. The safety program also addresses the risk associated with use of ablative and
therapeutic devices during diagnostic & interventional procedures, Laser and RF
devices.
j. Occupational health hazards are adequately addressed.*
k. Biomedical and hazardous waste is collected and disposed in a safe manner.*
l. Appropriate protective equipment and materials required to decontaminate and

manage exposure to biomedical waste and hazardous substances are available
and maintained.
m. Staff are appropriately oriented and trained for these.

Chapter 3
Facility Management and

Safety (FMS)

The organization works towards provision of a safe and secure environment for patients, their
families, staff and visitors. This includes risk mitigations as well as environmental safety.
Appropriate signage guides the visitors. Regular facility inspection rounds are conducted, and
appropriate actions are taken to ensure safety. The organization provides safe water, electricity,
medical gases and vacuum systems as required by the scope of services. The organization
plans for managing emergencies within the facilities. The organization plans for safe
management of hazardous materials in the facility and environment.
Facility Management and Safety (FMS) 17

FMS.1. The organization has a system in place to provide a safe and secure
environment.
FMS.2. The organization's environment and facilities operate in a planned

manner to ensure safety of patients, their families, staff and visitors
and promotes environment friendly measures.
FMS.3. The organization has plans for fire and non-fire emergencies within
the facilities.

Standard
FMS.1. The organization has a system in place to provide a safe and secure
environment.
Objective Elements
a. MIS coordinates development, implementation and monitoring of the safety plan and
policies.
b. Patient-safety devices & infrastructure are installed across the organization and inspected
periodically.
c. There is a documented procedure for equipment/material replacement and disposal.
d. Facility inspection rounds to ensure safety are conducted.
e. Inspection reports are documented and corrective and preventive measures are
undertaken.
Standard
FMS.2. The organization's environment and facilities operate in a planned

manner to ensure safety of patients, their families, staff and visitors
and promotes environment friendly measures.
Objective Elements
a. Facilities are appropriate to the scope of services of the organization.
b. Up-to-date drawings are maintained which detail the site layout, floor plans and fire-
escape routes.
c. There is appropriate internal and external sign postings in the organization in a language
understood by patient, families and community.
d. The provision of space shall be in accordance with the current good practices (Indian or
International Standards) and directives from government agencies.

e. Potable water and electricity are available round the clock.
f. Alternative sources for electricity and water are provided as backup for any failure /
shortage especially for the equipment and the organization regularly tests these
alternative sources.
g. There is a maintenance plan for electrical systems.
h. There are designated individuals (with appropriate equipment) responsible for the
maintenance of all the facilities.
i. Maintenance staff is appropriately qualified, trained and contactable round the clock for
emergency repairs.
j. There is a maintenance plan for facility and furniture.
k. Response times are monitored from reporting to inspection and implementation of

corrective actions.
l. The organization takes initiatives towards an energy efficient and environmental friendly
facility.
Standards
FMS.3. The organization has plans for fire and non-fire emergencies within
the facilities.
Objective Elements
a. The organisation has plans and provisions for early detection, abatement and
containment of fire and non-fire emergencies.*
b. The organization has a documented safe-exit plan in case of fire and non-fire
emergencies.*
c. Staff is trained for their role in case of such emergencies.
d. Mock drills are held at least twice in a year.
e. There is a maintenance plan for fire-related equipment & infrastructure.

Chapter 4
Equipment, Material and

Medications (EMM)

The organization ensures appropriate procurement, installation, operation, maintenance, quality
assurance and replacement of all equipment including ancillary equipment such as resuscitation
equipment, protective clothing and consumables. These are preformed in accordance with the
prevailing laws and National Guidelines. The organization has a safe and organized policies and
procedures that guide the availability, safe storage, prescription, dispensing and administration
of Contrast media, Radioisotopes and medications. It ensures proper storage of the medications
and follows all the required safety measures. The emergency medications are standardized
throughout the organization, readily available and replenished in a timely manner; a mentoring
mechanism ensures this. Safe use of high-risk medication like narcotics, chemotherapeutic
agents and radioactive isotopes are guided by policies and procedures. The organization
ensures monitoring of patients after administration of medications including contrast media and
Isotopes. There are procedures for reporting and analysing medication errors. Documented
policies and procedures guide the use of devices for Interventional Radiology as well as
therapeutic use of Radioactive Isotopes.
Equipment, Material and Medications (EMM) 21

EMM.1. Documented policies and procedures guide the management of all
Equipment.
EMM.2. Documented policies and procedures guide the procurement,

storage and usage of medication.
EMM.3. Documented policies and procedures guide the safe and rational use
of contrast media and medications.
EMM.4. The organization has documented policies and procedures that

govern diagnostic usage of radiopharmaceuticals.
EMM.5. Documented policies and procedures guide the use of medical

supplies and consumables, stents, coils and other implantable and
ablative medical devices.

govern therapeutic usage of radiopharmaceuticals.
*This implies that this objective element requires documentation

Standard
EMM.1. Documented policies and procedures guide the management of all

Equipment.
Objective Elements
a. The organization plans for equipment in accordance with its services and strategic plan.
b. Equipment are inventoried and proper equipment history and logs are maintained.
c. The installation of the equipment is safe and commensurate with the applicable laws.
d. The operation of the equipment is safe and compliant with the applicable laws.
e. Appropriate Calibration and Quality Assurance of the equipment is performed at a defined

periodicity.
f. There is a documented operational and maintenance (preventive and breakdown) plan

for all equipment.*
g. Equipment cleaning and disinfection adheres to the transmission based precautions at all
times.
h. The organization identifies and plans for obsolescence, condemning and

decommissioning of the equipment.
i. Qualified and trained personnel inspect, test and maintain equipment and utility systems.
Standard
EMM.2. Documented policies and procedures guide the procurement, storage

and usage of medication.
Objective Elements
a. There is a documented policy and procedure for procurement and stocking of Contrast
media, Radiopharmaceuticals and other medications commensurate with the scope of
services.*

b. Documented policies and procedures exist for storage of medication in a clean, safe and
secure environment.
c. Sound inventory control practices guide storage of the medications.
d. There is a documented policy for usage of multidose packaging and their discard.
e. The staff is oriented to these.
Standard
EMM.3. Documented policies and procedures guide the safe and rational use
of contrast media and medications.
Objective Elements
a. There is a documented contrast media policy which is commensurate with current best
practices and the staff is aware of this.*
b. Contrast media and other medications are handled and administered by those who are
permitted and trained to do so.
c. There is a documented procedure for managing drug reactions, and other adverse drug
events.
d. There is a system in place to identify patients at a high risk for adverse events following
contrast injections.
e. Documented procedures guide monitoring of patients during and after administration of

contrast media and other medication.
Standard

govern diagnostic usage of radiopharmaceuticals.
Objective Elements
a. The policies and procedures include the safe storage, preparation, handling, distribution,
administration and disposal of radiopharmaceuticals.
b. These policies and procedures are in consonance with laws and regulations.*

c. This includes management of spills and personnel contamination.
d. The patients at higher risk of adverse reactions to specific drugs, isotopes and
radiopharmaceuticals are identified, assessed and managed.
e. Staff, patients and visitors are educated on safety precautions and management of
adverse events.
Standard
EMM.5. Documented policies and procedures guide the use of medical

supplies and consumables, stents, coils and other implantable and
ablative medical devices.
Objective Elements
a. The usage is rational, safe and commensurate with the current best practices.
b. Documented policies and procedures govern procurement, storage and usage.*
c. It includes the policy and procedures for reuse and re-sterilization of single use devices.
d. Discharge Summary is provided in case of any implant procedure including the details of
the implant.
e. Patient and family are educated about the implanted prosthesis and medical device
including their maintenance and precautions.
f. Sound inventory control practices guide storage and usage of medical supplies and
consumables.
Standard
govern therapeutic usage of radiopharmaceuticals.
Objective Elements
a. The policies and procedures include the safe storage, preparation, handling, distribution,
administration and disposal of radiopharmaceutical.
b. These policies and procedures are in consonance with laws and regulations.*

c. Radiopharmaceuticals will be handled and administered by appropriately qualified and
authorized & trained individuals.
d. Protocols for dosage, administration and monitoring of patients undergoing therapy are
developed, documented and implemented.
e. Patient and patient care providers are appropriately informed & trained.
f. This includes management of radioactive spills as well as body fluids and biological waste
and personnel contamination.
g. The patients at higher risk of adverse reactions to specific drugs, isotopes and
radiopharmaceuticals are identified, assessed and managed.
h. The facility is in compliance with the national regulations regarding the facility layout and
construction.
i. The protocols followed in the isolation units are defined.
j. All patients are provided a comprehensive discharge document.
k. Staff are appropriately oriented and trained for these.

Chapter 5
Human Resource
Management (HRM)
Human resources are an asset for effective and efficient functioning of a Healthcare
Organization. The goal of human resource management is to acquire, provide, retain and
maintain competent people in right numbers to meet the needs of the patients and community
served by the organization. The management of staff is effective, fair, consistent and supportive.
Management of staff should comply with current legislation and current best practice. To ensure
high quality care to patients, the organization works to ensure that the staff is acquired in right
numbers and skill mix to meet the needs of the patients and community served by the
organization. All the staff is supported to maintain, improve and widen the scope of their
competencies. It is duty of the organization to ensure fair and consistent handling of all
complaints and grievances from staff within a defined timeframe. The organization ensures that
there is a well-documented performance appraisal system in the organization, and it is used as
a tool for further development. The staff is aware of the Human Resource policies as are
applicable to them.
Human Resource Management (HRM) 27

HRM.1. The organization has a documented system of human resource

planning.
HRM.2. The organization has a documented training program for the staff.
HRM.3. The organization has a documented human resource management

process.
HRM.4. There is documented personal information for each staff member.

Standard
HRM.1. The organization has a documented system of human resource

planning.
Objective Elements
a. The organization maintains an adequate number and mix of staff to meet the needs of the
organization.*
b. There is a documented procedure for recruitment, selection of staff.*
c. Job specification and job description are defined and documented or each category of
staff.
d. The credentials, skills and training of the staff is verified.
e. The organization verifies the antecedents of the potential employee with regards to
criminal/negligent background.
f. There is a defined process of authorization and privileging for all healthcare providers for
the services assigned to them.
g. There are clearly defined roles and supervisory requirements for the students, trainees
and volunteers.
Standard
HRM.2. The organization has a documented training program for the staff.
Objective Elements
a. Every staff member is made aware through induction training of organization’s wide
policies and procedures.
b. A documented training and development policy exists for the staff.*
c. Retraining occurs at a defined periodicity; and also when job responsibility changes
and/or new equipment is introduced.

d. Staff are trained on the risks as applicable to the organization's environment at a defined
periodicity.
e. Staff are also trained on occupational safety aspects.
Standard
HRM.3. The organization has a documented human resource management

process.
Objective Elements
a. A documented performance appraisal and competency evaluation system exists in the

organization at a defined periodicity.*
b. The Organization encourages and promotes competency development.
c. The organization has documented disciplinary and grievance handling policies and
procedures based on the principles of natural justice and the staff is aware of these.
d. There is a provision for appeals & redress procedure to addresses the grievance.
e. Medical Imaging Services ensure that there is a provision for health checkups; health and
other benefits to the staff.
Standard
HRM.4. There is documented personal information for each staff member.
Objective Elements
a. A personal file is maintained for each staff member.
b. The personal files contain information regarding the staff’s qualification, background and
health status.
c. All records of in-service training and education are contained in the personal files.
d. This includes information on the credentialing and privileging of staff members for
performing all imaging related procedures.
e. Personal files contain results of all evaluations.

Chapter 6
Management of Quality
and Safety (MQS)

The responsibilities of the management are defined. The organization complies with all
applicable regulations. The responsibilities of the leaders at all levels are defined. Leaders
ensure that patient-safety and risk-management issues are an integral part of patient care and
hospital management. The Management monitors the quality of Imaging, Interventional
procedures and image interpretation and promotes continuous improvement at all levels. The
management monitors the managerial indicators and turnaround times and promotes continuous
improvement at all levels.
Management of Quality and Safety (MQS) 31

MQS.1. Roles of management are defined.
MQS.2. The organization has a structured quality improvement program.
MQS.3. Organization identifies and monitors quality of imaging studies and

reports.
MQS.4. Organization identifies and monitors managerial services.
MQS.5. The management ensures patient & staff safety in the organization.

Standard
MQS.1. Roles of management are defined.
Objective Elements
a. Management defines the organisation’s Vision, Mission and Values.*
b. Management chooses leaders and establishes hierarchy in the organization.
c. Management is aware of current applicable laws and ensures that the organization
adheres to them.
d. Management ensures acquisition of all relevant licenses and their updation.*
e. Management ensures ethical management of all patient services that the organization
provides.
f. The Management ensures that all policies and protocols are developed and documented
to guide the functioning of the organization.
Standard
MQS.2. The organization has a structured quality improvement program.
Objective Elements
a. A continual quality improvement program is developed, documented and implemented

throughout the organization.*
b. The program is periodically reviewed and updated at least once in a year.
c. The organization conducts regular audits for efficiency of services.
d. The organization identifies and monitors priority clinical, managerial, infrastructural

parameters in the organization.

Standard
MQS.3. Organization identifies and monitors quality of imaging studies and

reports.
Objective Elements
a. The organization monitors appropriateness of imaging.
b. The organization conducts regular audits for image quality, acquisition protocol
adherence and deviations and completeness of imagining for the clinical indications.
c. The organization monitors redo’s of imaging procedures and recalls of reports.
d. The organization conducts regular audits for completeness and accuracy of reports.
e. The program addresses periodic internal/ external peer review.
f. The program addresses surveillance of imaging results with clinical correlation and follow
up wherever possible.
g. The program includes a system to obtain feedback from referring colleagues.
h. There is a system of periodic review to ensure that feedback is utilized to improve

services.
Standard
MQS.4. Organization identifies and monitors managerial services
Objective Elements
a. The organization monitors utilization of space equipment, service and manpower.
b. The organization monitors TAT of reports generation.
c. The organization monitors patient waiting times.
d. The program includes a system to obtain feedback from patients and visitors on all
aspects of services.
e. There is a system of periodic review to ensure that feedback is utilized to improve

services.

Standard
MQS.5. The management ensures patient & staff safety in the organization.
Objective Elements
a. A comprehensive safety program is developed, documented and implemented throughout

the organization.*
b. The safety program includes pro-active risk assessment.
c. The program is periodically reviewed and updated at least once a year.
d. The organization conducts regular audits for patient safety program.
e. The program addresses radiation safety of patients and attendants.
f. The program addresses risk of contrast, sedation and anaesthesia.
g. The program addresses physical safety and security of premises.
h. The program addresses the availability of patient safety devices across the organization.
i. The program addresses safety from violence, aggression and abuse.
j. The program includes reporting, analysis of adverse events ranging from ‘no harm’ to
‘sentinel’ events.
k. The program addresses Prevention of Sexual Harassment.

Chapter 7
Information Management
System (IMS)
Information is an important resource for effective and efficient delivery of healthcare. Provision
of healthcare and its continued improvement is dependent to a large extent on the information
generated, stored and utilized appropriately by the organization. The data and information meet
the organization’s needs and support the delivery of quality care and service. Documented
policies and procedures are in place for storage of Imaging and other records; and for
maintaining confidentiality, integrity and security of records, data and information.
Information Management System (IMS) 36

The organization has a robust information management system to

IMS.1.
meet information needs of the care providers, management as well
as other agencies.
IMS.2. The organization has an imaging record for every patient and it aids
continuity of care.
IMS.3. Documented policies and procedures are in place for maintaining

confidentiality, integrity and security of records, data and
information.

Standard
IMS.1. The organization has a robust information management system to

meet information needs of the care providers, management as well as
other agencies.
Objective Elements
a. The Information and Information-Technology needs of the organization are identified.
b. Documented policies and procedures guide the use of remote access to patient data and
images and Teleradiology facility as required in a safe and secure manner.*
c. The organization contributes to external databases in accordance with the law and
regulations. (AERB, PC-PNDT, NABH and others).
d. The organization has an effective process for document control.
e. Documented procedures exist for storing and retrieving data.
Standards
IMS.2. The organization has a imaging record for every patient and it aids
continuity of care
Objective Elements
a. Every imaging record includes a unique identifier for each patient which is maintained for
each patient on all subsequent visits.
b. Organization policy identifies those authorized to make entries in imaging record.*
c. The mandatory contents of imaging record are identified and documented.
d. Information on the invasive procedures performed are incorporated and the medical
record contains a copy of the discharge summary duly verified by appropriate and
qualified personnel.

Standards
IMS.3. Documented policies and procedures are in place for maintaining

confidentiality, integrity and security of records, data and information.
Objective Elements
a. Documented policies and procedures exist for maintaining confidentiality, security and
integrity of records, data and information.*
b. The policies and procedure (s) incorporate safeguarding of data/ record against loss,
destruction and tampering.
c. A documented procedure exists on how to respond to the requests of patients/physicians

and other public agencies for access to information in the medical record in accordance
with the local and national law.
d. The staff is aware of these.

8
Comparative Study:
1st Edition to 2nd Edition
MIS - 1st Edition - Standards / Objective elements Matching clause in

MIS - 2nd Edition
CHAPTER 1
Control of Services (CS)
CS.1. Medical Imaging Services shall address

systems to ensure delivery of the service from
point of referral to discharge.
a Roles and responsibilities of each area of service This is reworded

delivery are defined.
b Medical Imaging Services ensure justification of AAC.2.d

referrals according to patient’s condition, urgency of
diagnosis and radiation risk.
c Medical Imaging Services ensure that protocols for IPI.1.b

imaging pathways and processes are defined,
documented, implemented and monitored.
d Medical Imaging Services ensure appropriate AAPC.2.e

scheduling and prioritisation of referrals according
to patient’s condition and urgency of diagnosis.
e Timeframe to manage imaging pathways from Included

receiving of referral to discharge from the Medical
Imaging Services is defined, documented,
implemented and monitored.
©National Accreditation Board for Hospitals and Healthcare Providers 40

CS.2. Medical Imaging Services ensure that the
delivery of service is patient focused.
a Roles and responsibilities for staff managing each AAPC.1.c

area of service to the patient (information, AAPC.3.h
delivering of service and care, safety, privacy) are AAPC.5.d
defined. IPI.1.h
b. Medical Imaging Services ensure that the AAPC.3.b

information about specific procedure is available to
patients and attendant in relevant format and
language.
c Medical Imaging Services ensure that informed AAPC.4

consent is obtained from the patient or a AAPC.4.a
responsible attendants by designated staff in
AAPC.4.b
relevant format and language.
AAPC.4.c
AAPC.4.d
d Medical Imaging Services ensure that patient and AAPC.3.c

attendants are informed about expected cost prior
to imaging.
e Medical Imaging Services ensure safety of patients, FMS.2

attendants and their belongings while in the facility.
f Medical Imaging Services ensure safe transport of AAPC.6

the patients within, to and from the facility whenever AAPC.6.f
required.
g Medical Imaging Services ensure privacy and AAPC.3.e

dignity of the patient without any discrimination.
h Medical Imaging Services ensure that patient MQS.4.d

feedbacks are utilised to improve the service MQS.4.e
delivery system.
i Medical Imaging Services ensure that staff is aware AAPC.3.h

about patient’s rights and responsibilities.

CS.3. Medical Imaging Services ensure appropriate
management of facility and environment.
a Roles and responsibilities of management of each reworded

area of facility are defined.
b Medical Imaging Services ensure signage in FMS.2.c

appropriate language and format to guide the
patient and attendant to and within the facility.
c Medical Imaging Services ensure that design and EMM.6.h

construction of the facility is in accordance with the
legal requirements pertaining to the equipment and
the services offered.
d Medical Imaging Services ensure that design and FMS.2.b

construction of the facility supports specific needs
of the patient population (including children and
those with particular needs) and staff.
e Medical Imaging Services ensure that access to IPI.7.c

particular areas is restricted according to specific
needs and risks with proper barrier and signage.
f Medical Imaging Services ensure that water, FMS.2.f

electricity, ventilation and medical gases & vacuum
installation in all area of service is maintained with
provision of alternate sources.
CHAPTER 2
Control of Imaging Processes and Procedures
(CPP)
CPP.1. Medical Imaging Services ensure acquisition of IPI.1

optimal diagnostic quality images and the
performance of diagnostic procedures.
a Roles and responsibilities of staff for management reworded

of each area of image acquisition and image quality
are defined.

b Medical Imaging Services ensure that protocols for IPI.1.a
image acquisition for all examination are
developed, defined, documented, communicated, IPI.1.b
implemented and monitored. IPI.1.c
c Medical Imaging Services ensure quality of MQS.3.a

diagnostic images and procedures.
d Medical Imaging Services ensure analysis of MQS.3.d

feedback on images and procedures through MQS.3.f
documented process of internal verification &
external validation.
CPP.2. Medical Imaging Services ensure the quality of

reports (clinical and technical)
a Roles and responsibilities for staff reporting images reworded

are defined.
b Medical Imaging Services ensure that the structure, IPI.3

content and format of report is standardized. IPI.3.c
IPI.3.d
IPI.3.e
IPI.3.f
c Medical Imaging Services ensure the generation, MQS.4.b

verification and amendments of reports are within
appropriately defined timeframe.
d Medical Imaging Services ensure that all attempts IMS.2

are made so that the imaging interpretation is
collated with relevant clinical laboratory and
previous imaging details.
e Medical Imaging Services ensure communication of IPI.4.a

reports to patient and/or referrer within IPI.4.c
appropriately defined timeframe.

f Medical Imaging Services ensure appropriate IPI.5.d
quality of images and reports for teleradiology IPI.5.e
services. MQS.3.b
g Medical Imaging Services ensure analysis of MQS.3 f

feedback from Referrer / Professional colleagues
on the content and quality of reports through
defined & documented process.
CPP.3. CPP3. Medical Imaging Services ensure quality IPI.2

of diagnostic & therapeutic interventional
procedures.
a Roles and responsibilities for staff conducting IPI.2.a

diagnostic and therapeutic interventional
procedures are defined.
b Medical Imaging Services ensure that risk, AAPC.4.b

expected outcome and alternative treatment IPI.2.c
protocols are explained to the patient attendant and
referrer and same is documented.
c Medical Imaging Services ensure that protocols for IPI.2.b

all diagnostic and therapeutic interventional
procedures are defined, documented ,
d Medical Imaging Services ensure that appropriate IPI.2.i

sedation/ anaesthesia, clinical and emergency
support is available before, during and after the
procedure.
e Medical Imaging Services ensure that the IPI.2.k

outcomes of diagnostic and therapeutic
interventional procedures are monitored
CPP.4. Medical Imaging Services ensure proper

management of drugs, isotopes, contrast
media and radiopharmaceuticals.

a Roles and responsibilities for staff in the area of EMM.3.a
drugs, isotopes, contrast media and
radiopharmaceuticals are defined.
b Medical Imaging Services ensure that protocols for EMM.2.a

prescription, purchase, storage, supply, handling EMM.2.b
and labelling of drugs, isotopes, contrast media and
EMM.2.c
radiopharmaceuticals are defined, documented,
EMM.2.d
EMM.3.b
EMM.4.a
EMM.6.a
c Medical Imaging Services ensure that protocols for EMM.3.c

administration of drugs, isotopes, contrast media EMM.3.e
and radio pharmaceuticals to the patients including
EMM.4.a
corrective action taken in case of adverse drug /
contrast reaction are defined, documented,
d Medical Imaging Services ensure that patients at EMM.3.d

higher risk of adverse reactions to specific drugs, EMM.4.d
isotopes, contrast media and radiophar- EMM.6.g
maceuticals are assessed and managed.
CHAPTER 3
Control of Personnel (CP)
CP.1. Medical Imaging Services ensure that the staff

is appropriately qualified, competent and
trained, to deliver the services assigned to
them.
a Roles and responsibilities for maintenance of HRM.1.d

record and verification of credentials of the staff are
defined.
b Medical Imaging Services ensure that policies and HRM.1.b

procedures for selection, recruitment, retention and
succession planning of staff are defined,
documented and implemented.

c Medical Imaging Services ensure that there is a HRM.4
documented personal record for each staff HRM.4.a
member. HRM.4.b
HRM.4.e
CP.2. Medical Imaging Services ensure appropriate

Human resource planning of staff to deliver the
service.
a Roles and responsibilities of management to carry HRM.1

out the processes of authorization, management
and support to staff to deliver the service are
defined.
b Medical Imaging Services ensure that appropriate HRM.1.a

skill mix and staff complement exist in accordance
with the scope of services for specific areas of task.
c Medical Imaging Services ensure that job HRM.1.c

description and specification for each category of
staff is defined, documented and communicated.
d Medical Imaging Services ensure that students, HRM1.g

trainees & volunteers working in patient care areas
have clearly defined roles and supervision as
specified.
e Medical Imaging Services ensure induction training HRM.2.a

and regular ongoing program for training and HRM.2.b
development of the staff.
CP.3. Medical Imaging Services ensure fair and

rational Human Resource Management.
a Roles and responsibilities of the management of HRM.3.a

human resource pertaining to staff benefits, HRM.3.b
appraisals, disciplinary action and grievance
handling are clearly defined.

b Medical Imaging Services ensure that there is included
provision for health checkups; health and other
benefits to the staff.
c Medical Imaging Services ensure that a system of HRM.3.a

regular service appraisals and personal
development reviews exist for all employees.
d Medical Imaging Services ensure that policies and HRM.3.b

procedures regarding disciplinary action against
any staff is defined, documented and
communicated.
e Medical Imaging Services ensure that staff HRM.3.b

grievance handling procedures are clearly defined, HRM.3.c
documented and communicated.
CHAPTER 4
Control of Equipment (CE)
CE.1. Medical Imaging Services ensure appropriate EMM.1.a

procurement and installation of the equipment.
a Medical Imaging Services ensure that the policies EMM.2.a

and procedures for the procurement of all EMM.5.b
equipment and consumables are defined,
implemented and monitored in a collaborative
manner between user and management.
b Medical Imaging Services ensure that the policies EMM.1.d

and procedures for the installation of equipments
are defined, documented, implemented and
monitored and record of same is maintained.
CE.2. Medical Imaging Services ensure appropriate

operation and working of the equipment.
a Roles and responsibilities for each area of the reworded

operation and working of all equipments are
defined, documented, implemented and monitored.

b Medical Imaging Services ensure that the policies EMM.1.f
and procedures for operation and calibration of
equipment are defined, documented, implemented,
monitored and record of the same is maintained.

maintenance and repair of the equipment.
a Roles and responsibilities for maintenance, service EMM.1.b

and repair of the equipment are defined.
b Medical Imaging Services ensure that equipment Included

downtimes are monitored and managed within
defined timeframe.
c Medical Imaging Services ensure that policies and EMM.1.c

procedure for maintenance and repair of equipment EMM.1.g
monitored and record of the same is maintained.

replacement of existing equipment & planning
for new equipment for continuation and
expansion of service.
a Roles & responsibilities for replacement of existing EMM.1.i

equipment & planning for new equipment for
expansion of service are defined.
b Medical Imaging Services ensure that equipment EMM.1.i

replacement and/or up- gradation is planned and
implemented in accordance with scope of services
and expansion plan.
CHAPTER 5
Control of Documents and Record (CDR)
CDR.1. Medical Imaging Services ensure appropriate

management of all the documents, images and
records pertaining to patient.

a Roles and responsibilities for generation, IMS.3.a
maintenance, integration, safety, confidentiality and IMS.1.e
retrievability of all the documents, images and
records are defined.
b Medical Imaging Services ensure that policies and IMS.2.a

procedures to identify, and classify documents, IMS.2
images and records pertaining to the patient are
IMS.1.e
defined, preferably in computerised format.
c Medical Imaging Services ensure that policies and AAPC.3.f

procedures regarding retention, confidentiality and IMS.1.e
retrievability of all the documents, images and
IMS.1.f
records are implemented and monitored.
CDR.2. Medical Imaging Services ensure generation,

completion, revision, retention and
dissemination of information documents for
staff, patients and others.
a Roles and responsibilities for generation, IMS.1.e

completion, revision, retention and dissemination of
staff and patient information data (in designated
format and language) are defined.
b Medical Imaging Services ensure that policies and IMS.1.e

procedures for generation, completion, revision,
retention and dissemination of staff and patient
information & instruction data in designated format
and language are defined documented and
implemented.
c Medical Imaging Services ensure that feedback MQS.3.g

from staff, patient and others are utilized for
continuous improvement of service.
CDR.3. Medical Imaging Services ensure maintenance

of documents of legislative/regulatory and
statutory requirements related to facility,
equipment, personnel and risk monitoring.

a Roles and responsibilities for maintenance of MQS.1.d
documents of legal and statutory requirements
related to facility, equipment, personnel and risk
monitoring are maintained.
b Medical Imaging Services ensure that documents MQS.1.c

of legal and statutory requirements related to facility
are maintained.
c Medical Imaging Services ensure that document of EMM.1.e

legal and statutory requirements related to
equipments are maintained.
d Medical Imaging Services ensure that document of HRM.2.d

legal and statutory requirements related to all staff
including risk monitoring are maintained.
CDR.4. Medical Imaging Services ensure maintenance MQS.1.f

and updating of all records and documents
pertaining to audit, quality control & quality
improvement of all processes and services.
a Roles and responsibilities for maintenance and MQS.1.g

updating of all records and documents pertaining to
audit, quality control & quality improvement of all
processes and services are defined.
b Medical Imaging Services ensure that policies and MQS.2.c

procedures for audit, quality check, verification and MQS.2.d
validation are maintained.
c Medical Imaging Services ensure that all MQS.2.a

documents related to quality improvements are
maintained.
Chapter 6 MQS.5
(RCS) Risk Control and Safety
RCS.1. Medical Imaging Services ensure that the risk IPI.7.d

associated with imaging, interventional &
therapeutic procedures are identified,
assessed, managed and minimised.

a Roles & responsibilities for all level of risk IPI.7.b
management in all areas of imaging are defined.
b Medical Imaging Services ensure that the radiation IPI.7.a

doses are as low as reasonably possible for all
patients (ALARP principle) especially for children,
women of child bearing age, pregnant women and
patients undergoing repeated exposures.
c Medical Imaging Services ensure that there is a IPI.7.e

system in place to define, assess and manage risks IPI.7.f
of occupational exposure to ionising radiation and
record for the same is maintained.
d Medical Imaging Services ensure that risks of included

acoustic output and exposure times are defined,
assessed, managed and minimized.
e Medical Imaging Services ensured that risks IPI.7.g

associated with MRI imaging are defined,
assessed, managed and minimized.
f Medical Imaging Services ensure that risk included

associated with use of ablative, therapeutic devices
during diagnostic & interventional procedures are
defined, assessed and managed.
g Medical Imaging Services ensure that the incidents included in

& errors pertaining to risks associated with all the Management - safety
procedures are reported, investigated, recorded,
acted upon, analysed, and used to guide and plan
the future action.
RCS.2. Medical Imaging Services ensure that the risk

of infection to staff, patient and others is
identified, assessed, managed and minimised.
a Roles and responsibilities regarding infection IPI.2.g

control are defined.

b Medical Imaging Services ensure that policies and IPI 2.g
procedures to identify, assess, manage and
minimise the risk of infection to staff, patient and
others are defined, documented, implemented and
monitored.
c Medical Imaging Services ensure that policies and EMM.1.h

procedures for decontamination of equipment and
environmentare defined, documented,
d Medical Imaging Services ensure that protocols IPI.7.k

and procedures for needle stick injuries and
subsequent post exposure prophylaxis are

associated with hazardous/radioactive and bio-
medical (BMW) substances and materials to
staff, patient and others are identified,
assessed, managed and minimised.
a Roles and responsibilities for control of IPI 7.l, IPI 7.m

hazardous/radioactive and Bio- Medical Waste
(BMW) substances and materials are defined.
b Medical Imaging Services ensure that policies and EMM.6.f

minimise the risk associated with hazardous /
radioactive and Bio-medical waste (BMW)
substances and material to staff, patient and others
monitored.
c Medical Imaging Services ensure that appropriate Included

protective equipment required to decontaminate
and manage exposure to hazardous/ radioactive
substances are available and maintained.

d Medical Imaging Services ensure that the incidents Included
& errors pertaining to risks associated with
hazardous/ radioactive substances and materials
are reported, investigated, recorded, analysed,
acted upon and used to guide and plan the future
action.
RCS.4. Medical Imaging Services ensure that the risk of

violence and aggression to staff , patient and
others are identified, assessed, managed and
minimised.
a Roles and responsibilities regarding risk of violence MQS.5.i

and aggression are defined.
b Medical Imaging Services ensure that policies and MQS.5.i

minimise the risk of violence and aggression to
staff, patient and others are defined, documented,
c Medical Imaging Services ensure that incidents & MQS.5.i

errors pertaining to risks of violence and aggression
are reported, investigated, recorded, analysed,
acted upon and used to guide and plan the future
action.

associated with fire and non- fire emergencies
to staff, patient and others and to facility and
environment are identified, assessed, managed
and minimised.
a Roles and responsibilities regarding risk associated FMS.3

with fire, and non-fire emergencies are defined. FMS.3.c

b Medical Imaging Services ensure that policies and FMS.3.a
minimise the risk associated with fire, electrocution
and other disaster to staff, patient and others are
c Medical Imaging Services ensure that there are FMS.3.b

adequate safety equipment available, and that all FMS.3.d
the staff is aware and trained in handling them in an
FMS.3.e
emergency or disaster.

9
Glossary
The commonly-used terminologies in the NABH standards are briefly described and explained
herein to remove any ambiguity regarding their comprehension. The definitions narrated have
been taken from various authentic sources as stated, wherever possible. Notwithstanding the
accuracy of the explanations given, in the event of any discrepancy with a legal requirement
enshrined in the law of the land, the provisions of the latter shall apply.
A process of external review of the quality of the health care being

Accreditation
provided by a healthcare organization. This is generally carried out
by a non-governmental organization. It also represents the
outcome of the review and the decision that an eligible
organization meets an applicable set of standards.
Adult An individual who has capacity and is at least 18 years of age.
Adverse drug Adverse event: Any untoward medical occurrence that may
event present during treatment with a pharmaceutical product but which
does not necessarily have a causal relationship with this
treatment.
Adverse drug reaction: A response to a drug which is noxious and
unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of disease or for the
modification of physiologic function.
Adverse drug event: The FDA recognizes the term adverse drug
event to be a synonym for adverse event.
In the patient safety literature, the terms adverse drug event and
adverse event usually denote a causal association between the
drug and the event, but there is a wide spectrum of definitions for
these terms, including harm caused by a
• drug
• harm caused by drug use, and
• a medication error with or without harm

Institute of Medicine: “an injury resulting from medical intervention
related to a drug”, which has been simplified to “an injury resulting
from the use of a drug”
Adverse drug events extend beyond adverse drug reactions to
include harm from overdoses and under-doses usually related to
medication errors.
A minority of adverse drug events are medication errors, and
medication errors rarely result in adverse drug events.
A patient carrying vehicle having facilities to provide unless
Ambulance
otherwise indicated at least basic life support during the process
of transportation of patient. There are various types of
ambulances that provide special services viz. coronary care
ambulance, trauma ambulance, air ambulance, etc.
Emergency procedures performed to sustain life that include

Basic life support
cardiopulmonary resuscitation, control of bleeding, treatment of
(BLS)
shock, stabilization of injuries and wounds and first, aid.
Basic life support consists of a number of life-saving techniques
which are focused on the "ABC"s of emergency care:
• Airway: the protection and maintenance of patient airway
including the use of airway adjuncts such as an oral or nasal
airway
• Breathing: the actual flow of air through respiration, natural or
artificial respiration, often assisted by emergency oxygen
• Circulation: the movement of blood through the beating of the
heart or the emergency measure of CPR
BLS may also include considerations of patient transport.
Calibration is a set of operations which establishes, under
Calibration
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.

The administering of any means or device to support
Cardiopulmon-ary
cardiopulmonary functions in a patient, whether by mechanical
Resuscitation
devices, chest compressions, mouth–to–mouth resuscitation,
(CPR)
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.
Check is a measurement of at least one point in a range of a

Check
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.
Competence Demonstrated ability to apply knowledge and skills.
Computerized A non-invasive radiological diagnostic procedure that may or may

Tomography not include nuclear medical dye.
Restricted access to information to individuals who have a need,

Confidentiality
a reason and permission for such access. It also includes an
individual’s right to personal privacy as well as privacy of
information related to his/her healthcare records.
Consent Willingness of a party to undergo examination/procedure/

treatment by a healthcare provider. It may be implied (e.g. patient
registering in OPD), expressed which may be written or verbal.
Informed consent is a type of consent in which the healthcare
provider has a duty to inform his/her patient about the procedure,
its potential risk and benefits, alternative procedure with their risk
and benefits so as to enable the patient to take an informed
decision of his/her healthcare.
In law, it means active acquiescence or silent compliance by a
person legally capable of consenting. In India, legal age of consent
is 18 years.
It may be evidenced by words or acts or by silence when silence
implies concurrence. Actual or implied consent is necessarily an
element in every contract and every agreement.
The process of obtaining, verifying and assessing the qualification
Credentialing
of a healthcare provider.

Document is any information or instruction including policy
Document
statement, text books, procedure, specifications, calibration
tables, posters, charts, notices, drawings, plans and document
of external origins like regulations, standards or examination
procedures.
A judicially appointed guardian or conservator having authority to
Guardian
make a healthcare decision for an individual.
Sequence of activities carried out to address the grievances of
Grievance
handling patients, visitors, relatives and staff.
procedures
Hazardous Substances dangerous to human and other living organisms.

materials They include radioactive or chemical materials.
Hazardous waste Waste materials dangerous to living organisms. Such materials

require special precautions for disposal. They include biologic
waste that can transmit disease (for example, blood, tissues)
radioactive materials, and toxic chemicals. Other examples are
infectious waste such as used needles, used bandages and fluid
soaked items.
A statistical measure of the performance of functions, systems or
Indicator
processes overtime. For example, infection rate, adverse event
rate etc.
Solid or liquid wastes which contain pathogens with sufficient
Infectious Waste
virulence and quantity such that exposure to the waste by a
susceptible host could result in an infectious disease
The method of supervising the intake, use and disposal of various
Inventory control
goods in hands. It relates to supervision of the supply, storage and
accessibility of items in order to ensure adequate supply without
stock outs/excessive storage. It is also the process of balancing
ordering costs against carrying costs of the inventory so as to
minimise total costs
Job description 1. It entails an explanation pertaining to duties, responsibilities and

conditions required to perform a job.
2. A summary of the most important features of a job, including the
general nature of the work performed (duties and responsibilities)
and level (i.e., skill, effort, responsibility and working conditions)
of the work performed. It typically includes job specifications that
include employee characteristics required for competent
performance of the job. A job description should describe and

focus on the job itself and not on any specific individual who might
fill the job.
Magnetic A non-invasive diagnostic technique that produces computerized

Resonance images of internal body tissues and is based on nuclear magnetic
resonance of atoms within the body induced by the application
Imaging (MRI).
of radio waves
Mammography A non-invasive radiological procedure used to take pictures of the

breasts in order to diagnose tumours or cysts.
Medical Any fixed or portable non-drug item or apparatus used for

equipment diagnosis, treatment, monitoring and direct care of patient.
Medical histories, records, reports, summaries, diagnoses,

Medical Record
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.
The performance and analysis of routine measurements aimed at
Monitoring
identifying and detecting changes in the health status or the
environment, e.g. monitoring of growth and nutritional status, air
quality in operation theatre. It requires careful planning and use of
standardised procedures and methods of data collection.
A document, which contains the chronological sequence of events

Patient record/
that a patient undergoes during his stay in the healthcare
Medical record/ organization. It includes demographic data of the patient,
clinical record assessment findings, diagnosis, consultations, procedures
undergone, progress notes and discharge summary. (Death
certificate wherever required)
The hazards to which an individual is exposed during the course

Occupational
health hazard of performance of his job. These include physical, chemical,
biological, mechanical and psychosocial hazards.
Images which provide necessary and sufficient diagnostic

Optimal
information to provide an accurate diagnosis
diagnostic Quality
image

PCPNDT Act Pre-conception and Pre-natal Diagnostic Techniques
(Prohibition of Sex Selection) Rules, 1996, 2003
It is the process of evaluating the performance of employees
Performance
during a defined period of time with the aim of ascertaining their
appraisal
suitability for the job, potential for growth as well as determining
training needs.
Policies They are the guidelines for decision making, e.g. admission,
discharge policies, antibiotic policy, etc.
It is the process for authorising all medical professionals to admit
Privileging
and treat patients and provide other clinical services
commensurate with their qualifications and skills.
Procedure 1. A specified way to carry out an activity or a process.

(Para 3.4.5 of ISO 9000:2000)
2. A series of activities for carrying out work which when observed
by all help to ensure the maximum use of resources and efforts to
achieve the desired output.
A set of interrelated or interacting activities which transforms
Process
inputs into outputs (Para 3.4.1 of ISO 9000:2000).
Positron Emission A non-invasive radiological procedure producing a sectional view

of the body constructed by positron-emission tomography.
Tomography (PET
scan)
A plan or a set of steps to be followed in a study, an investigation
Protocol
or an intervention.
Quality 1.Degree to which a set of inherent characteristics fulfil

requirements (Para 3.1.1 of ISO 9000:2000) Characteristics imply
a distinguishing feature (Para 3.5.1 of ISO 9000:2000)
Requirements are a need or expectation that is stated, generally
implied or obligatory (Para 3.1.2 of ISO 9000:2000)
2. Degree of adherence to pre-established criteria or standards.
Quality assurance Part of quality management focussed on
providing confidence that quality requirements will be fulfilled.
(Para 3.2.11 of ISO 9000:2000) Quality improvement ongoing
response to quality assessment data about a service in ways that
improve the process by which services are provided to
consumers/patients.

A person currently certified as such by the State registration
Radiological
Council as Radiological Technologist.
Technologist
A person currently licensed as such by the Nursing Council of
Registered Nurse
India.
Clinical and administrative activities to identify evaluate and
Risk management
reduce the risk of injury.
Safety The degree to which the risk of an intervention/procedure, in the

care environment are reduced for a patient, visitors and
healthcare providers
Range of clinical and supportive activities that are provided by a
Scope of services
healthcare organization.
Protection from loss, destruction, tampering, and unauthorized
Security
access or use.
A relatively infrequent, unexpected incident, related to system or
Sentinel events
process deficiencies, which leads to death or major and enduring
loss of function for a recipient of healthcare services. Major and
enduring loss of function refers to sensory, motor, physiological,
or psychological impairment not present at the time services were
sought or begun. The impairment lasts for a minimum period of two
weeks and is not related to an underlying condition.
All personnel working in the organization either as full paid
Staff
employees or as consultants on honorarium basis
A statement of expectation that defines the structures and
Standards
process that must be substantially in place in an organization to
enhance the quality of care.
It is the process of killing or removing microorganisms including
Sterilization
their spores by thermal, chemical or irradiation means.
The continuous scrutiny of factors that determines the occurrence
Surveillance
and distribution of diseases and other conditions of ill health. It
implies watching over with great attention, authority and often
with suspicion. It require professional analysis and sophisticated
interpretation of data leading to recommendations for control
activities.
The movement of a patient at the direction of a physician or
Transfer
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.

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
Form For Maintenance of Records By Genetic Laboratory
Ultrasound Form E
Form For Maintenance of Record In Respect of Pregnant
Ultrasound Form F
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.
Validation 1. Confirmation through the provision of objective evidence that

the requirements for a specific intended use or application have
been fulfilled (Para 3.8.5 of ISO 9000: 2000)
Objective Evidence – Data supporting the existence or variety of
something (Para 3.8.1 of ISO 9000: 2000)
2. The checking of data for correction or for compliance with
applicable standards, rules or conventions. These are the tests to
determine whether an implemented system fulfils its
requirements. It also refers to what extent does a test accurately
measure what it purports to measure.
Those patients who are prone to injury and disease by virtue of
Vulnerable patient
their age, sex, physical, mental and immunological status, e.g.
infants, elderly, physically and mentally challenged those on
immunosuppressive and/or chemotherapeutic agents.

List of Licenses and
Statutory Obligations
All of them might not be applicable to all the MIS:
1. AERB Act and Rules of Safety Code.
2. Building Permit (From the Municipal Corporation or appropriate body).
3. No objection certificate from the Chief Fire office.
4. License under Bio- medical Management and handling Rules, 1998.
5. No objection certificate under Pollution Control Act.
6. Radiation Protection Certificate in respect of all X-ray and CT Scanners from AERB.
7. Excise permit to store Spirit.
8. Income tax PAN.
9. Permit to operate lifts under the Lifts and escalators Act (If applicable).
10. Narcotics and Psychotropic substances Act and License.

11. Sales Tax Registration certificate.
12. Vehicle registration certificates for Ambulances (If applicable).
13. Consumer protection Act, 1986.
14. Contract Act, 1982.
15. Copyright Act, 1982.
16. Customs Act, 1962.
17. Drugs & cosmetics Act, 1940.
18. Electricity Act, 1998.
19. Employees provident fund Act.
20. ESI Act, 1948.
21. Equal remuneration Act, 1976.
22. Hire Purchase Act, 1972.

23. Indian medical council Act and code of medical ethics, 1956.
24. Maternity benefit Act, 1961.
25. MTP Act, 1971.
26. Minimum wages Act, 1948.
27. National building code.
28. Negotiable instruments Act, 1881.
29. Payment of bonus Act, 1965.
30. Payment of gratuity Act, 1972.
31. Payment of wages Act, 1936.
32. Persons with disability Act, 1995.
33. PNDT Act, 1996 and registration (If applicable).
34. Protection of human rights Act, 1993.
35. PPF Act, 1968.
36. Sale of goods Act, 1930.
37. Tax deducted at source Act.
38. Sales tax Act.
39. SC and ST Act, 1989.
40. Companies Act, 1956.
41. Urban land Act, 1976.

© National Accreditation Board for Hospitals and Healthcare Providers 65

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©National Accreditation Board for Hospitals and Healthcare Providers

QUALITY : SAFETY : WELLNESS

(Dr. Atul Mohan Kochhar)

Accreditation Standards for Medical Imaging Services

©National Accreditation Board for Hospitals and Healthcare Providers

2nd Edition December 2019

©National Accreditation Board for Hospitals and Healthcare Providers

©National Accreditation Board for Hospitals and Healthcare Providers

S. No. Particulars Page No.

01. Access, Assessment and Patient Care (AAPC) 1-8

02. Imaging, Procedures and Interpretations (IPI) 9 - 16

03. Facility Management and Safety (FMS) 17 - 20

04. Equipment, Material and Medications ( EMM) 21 - 26

05. Human Resource Management (HRM) 27 - 30

06. Management Of Quality And Safety (MQS) 31 - 35

07. Information Management System (IMS) 36 - 39

08. Comparative Study: 1st Edition to 2nd Edition 40 - 54

10. List of Licenses and Statutory Obligations 63 - 64

©National Accreditation Board for Hospitals and Healthcare Providers

Access, Assessment and

Access, Assessment and Patient Care (AAPC) 1

AAPC.1. The organization defines and displays the medical imaging

AAPC.2. The organization has a well-defined registration and admission

AAPC.4. The organization has a documented procedure for obtaining

AAPC.5. Emergency imaging services are guided by documented policies,

AAPC.6. Patient transportation and ambulance services are guided by

AAPC.7. Documented policies and procedures guide the care of patients

AAPC.8. Documented policies and procedures guide the care of patients

*This implies that this objective element requires documentation.

Access, Assessment and Patient Care (AAPC) 2

c. The staff are oriented to these services.*

AAPC.2. The organization has a well-defined registration and admission

Access, Assessment and Patient Care (AAPC) 3

e. There is a system in place for appropriate scheduling and prioritization

f. The staff are oriented to these.

a. Patients and families are informed of their rights and responsibilities in a

b. The information about specific procedure is available to patients and

c. The expected cost is informed prior to imaging.

e. The privacy and dignity of the patient is preserved without any

f. Confidentiality of patient information will be maintained.*

g. Patient and family have a right to seek an additional opinion.

h. The staff are aware and oriented to these.

Access, Assessment and Patient Care (AAPC) 4

AAPC.4. The organization has a documented procedure for obtaining informed

a. Documented policy incorporates the list of situations where informed

b. Informed consent includes information regarding the procedure, it’s risks,

d. Informed consent is taken by the person performing the procedure or by a

e. The staff are aware and oriented to these.

AAPC.5. Emergency imaging services are guided by documented policies,

a. The organization shall have a process of identification of emergencies.*

b. Documented policies and procedures guide the triaging of patients for

c. Documented protocols guide the handling of emergency patients in the

Access, Assessment and Patient Care (AAPC) 5

e. There is an identified area in the organization to receive and manage

f. Staff are appropriately trained to manage these.

AAPC.6. Patient transportation and ambulance services are guided by

a. Documented policies and procedures exist to ensure safe and timely

c. The ambulance and/or patient transport vehicle(s) adheres to statutory

d. The ambulance(s) and/or patient transport vehicle(s) is appropriately