1 

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.

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TABLE OF CONTENTS

Sl. Particulars Page No.

1. Introduction to Medical Imaging Services 3

2. Standards 4

3. Scope of Services 5

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

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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

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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

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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 communication system(PACS) Tele radiology

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Section-1

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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.

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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.

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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.

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CHAPTER 1 (CS) Control of Services

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.

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CHAPTER 1 (CS) Control of Services Standard

a. Medical Imaging service shall address systems to ensure delivery of the service from point of referral to discharge.

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 patient-focused.

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.

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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. MIS ensure that patient feedback are obtained, collated, analysed and used as guide

to future improvement in service delivery system.

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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 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

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CHAPTER 2 (CPP) Control of Processes and Procedures Standard

CPP 1 Medical Imaging service ensures the acquisition of optimal diagnostic quality images and performance of diagnostic procedures.

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.

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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.

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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.

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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 signage’s.

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

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c. 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.

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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.

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Chapter 4 (CP) Control of Personnel Standard

CP 1 Medical Imaging service ensures authorization, management and support to staff to deliver the service.

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

implemented and monitored.

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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 Medical Imaging service ensures service and workforce review,

planning and development.

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.

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CHAPTER 5 (CE) Control of Equipment 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. Medical Imaging service manages and monitors appropriate

maintenance and repair of the equipment to deliver the service. d. Medical Imaging service manages and monitors appropriate

replacement of existing equipment & planning for new equipment for continuation and expansion of service.

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Chapter 5 (CE) Control of Equipment Standard CE 1 Medical Imaging service ensures appropriate procurement and

installation of the equipments. 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,

implemented and monitored. d. MIS ensures that proper record of calibration of the equipments are maintained.

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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.

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Chapter 6

(CDR) Control of Documents and Record 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.

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Chapter 6 (CDR) Control of Documents and Record

Standard

CDR 1 Medical Imaging Services ensures generation, completion, revision, retention and dissemination of information documents for staff, patients 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. MIS ensures that personnel data records of all staff are maintained and periodically

updated.

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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 patient’s 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.

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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.

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Chapter 7 (RCS) Risk control and safety 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 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.

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Chapter 7 (RCS) Risk control and safety

Standard RCS1 Medical Imaging service ensures that the risk associated with imaging

procedures are identified, assessed, managed and minimised. 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.

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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. MIS ensures that protocols and procedures to identify, assess, manage and

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

hazardous substances and materials to staff, patient and others are identified, assessed, managed and minimised.

Objective elements a. Roles, responsibilities and accountabilities for the control of hazardous substances

and materials are defined. b. MIS ensures that protocols and procedures to identify, assess, manage and

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

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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, managed and minimised.

Objective elements a. Roles and responsibilities regarding risk of violence and aggression are defined. b. MIS ensures that protocols and procedures to identify, assess, manage and

minimise the risk of violence and aggression to staff, patient and others are defined, implemented and monitored.

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. MIS ensures that protocols and procedures to identify, assess, manage and

minimise

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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.

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Section 2

            35 

Chapter 1 (CS) Control of Services

CS 1 Medical Imaging service address systems to ensure delivery of the service from point of referral to discharge.

Medical imaging services shall ensure following services for delivering of service from point of referral to discharge:

1. Receiving the requisition/referral 2. Scheduling the examination 3. Reception, Registration and transport of patient 4. Patient information and consent regarding procedure, payment, report. 5. Patient identification 6. Patient preparation 7. Patient sedation if required 8. Performance of examination (protocols for imaging pathways and processes) 9. Patient care during and after procedure 10. Interpretation and reporting 11. Dispatch of report and advise regarding the result 12. 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 patient’s 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 • Patient’s 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 patient’s 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

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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

            39 

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 (CPP) Control of Processes and Procedures

CPP1 Medical Imaging Service ensures the acquisition of optimal diagnostic quality images and performance of diagnostic procedures.

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 practice’s 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.

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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

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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;

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• 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

• 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

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• 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;

MRI

• 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;

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;

• Pipelined gases and suction facilities;

• Availability of crash-cart trolley with emergency medicine tray and oxygen cylinder.

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• 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 Boyle’s apparatus, compatible with the imaging modality used.

• Pipelined gases and suction facilities;

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.

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Chapter 4 (CP) Control of Personnel

CP 1 Medical Imaging services ensures authorization, management and support to staff to deliver the service.

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. 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

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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; 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 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

• Radiologic technologists shall take X-rays and administer non radioactive materials into patient’s 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;

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• 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

Bone mineral densitometry

• 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

o Administration of radionuclide

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o 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 technologist’s exposure to unnecessary radiation;

• Keeping accurate records of the type, amount and effect of radionuclide’s administered;

MRI

• 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 patient’s examination.

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

• Provide assistance to the Radiologist performing the procedures and ensuring completeness of the consent form before the start of procedure.

CP 2 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:

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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. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance etc. There shall be appropriate staff at the reception, store, quality management, security, ambulance

etc. T There shall be appropriate staff at the reception, store, quality management, security, ambulance 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).

Bone mineral densitometry

The Radiologist shall have knowledge and understanding of:

• Bone structure, metabolism, and osteoporosis

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• 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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Interventional radiology

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 Medical Imaging service ensures service and workforce review, planning and development.

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) Control of Equipment

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)

Bone mineral densitometry

• 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.

• 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

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• 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 Boyle’s Trolley, Suction machine, emergency drugs to combat any allergic reactions due to contrast medium.

MRI

• 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.

Interventional radiology

• 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:

• Notice/certificate of registration or license where available • Quality control record • Safety testing record

CE 2 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:

• Identification of equipment

• Manufacturer’s name, type, identification and serial number or other unique identification

• Manufacturer’s contact persons and telephone numbers

• Date of receiving and date of putting into service

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• Current location, where appropriate

• Condition when received (new, used or reconditioned)

• Manufacturer’s 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 Medical Imaging service manages and monitors appropriate 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 manufacturer’s 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 • 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

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• 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

• Calibration of signal to noise ratio

Bone mineral densitometry • 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 • Calibration of signal to noise ratio

• 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

MRI • 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

CE 4 Medical Imaging service manages and monitors appropriate replacement of Existing equipment & planning for new equipment for expansion of service.

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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) Control of Documents and Record

CDR 1 Medical Imaging Services ensures generation, completion, revision, retention and dissemination of information documents for staff, patients 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 

imaging centre and it includes

• Patient identification

• 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 • Patient identification

• 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 examination’s 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 patient’s 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

Bone mineral densitometry 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

• Record of patient identification and referring clinician

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• Record of date and time of scan

• Record of name and signature of performing radiologist

• Record of sedation/contrast/medication if given

• Record of adverse reaction and remedial action taken

• Record of report, image and further advice and shall be retained for minimum of 2 years

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 patient’s medical record.

• Retention of the CT examination shall be consistent both with clinical need and with relevant legal and local health care facility requirements.

Interventional radiology

• Record of patient identification and referring clinician

• Record of date and time of scan

• Record of name and signature of performing radiologist

• Procedure or Operative record

• Record of sedation/contrast/medication if given

• Record of adverse reaction/complications and remedial action taken

• Record of report, image and further advice and shall be retained for minimum of 2 years 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 (RCS) Risk control and safety

RCS1 Medical Imaging service ensures that the risk associated with imaging procedures are identified, assessed, managed and minimised.

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 x-ray 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.

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• 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.

• A log of screening times for all fluoroscopic examinations must be kept.

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 act booklet must be available in the waiting room.

• Minimum acoustic output and exposure time

• Provision for anaesthetic coverage during interventional procedures.

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 • 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;

• Evacuation procedures, including a plan of the site showing the location of safety equipments and fire extinguishers;

• Provision for radiation monitoring through DRP/BARC

• A CAT scan is not recommended for a pregnant woman.

MRI

• Pre-entry safety check of all patients

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• 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.

Bone mineral densitometry

• 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

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• 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). • Evacuation procedures, including a plan of the site showing the location of safety equipments

and fire extinguishers;

•

Interventional Radiology

• 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.

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• 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.

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• 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

• Proper patient privacy

• Female technician to carry out studies

• Automatic processors

Ultrasound

• Female technician to assist.

• Clean hygienic disposable towel or tissue papers

Bone mineral densitometry

• 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

• 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;

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• 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.

MRI

• Provide reading material to patients to reduce apprehensions.

CT scan

• Radiation monitoring devices for all technical and staff through DRP/BARC

• 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

Interventional radiology MIS shall ensure that for the Cath Lab x-ray installations procurement is of type approved x-ray 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.

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There shall be defined policies and protocols for decontamination of equipment and environment following an incident. Cleaning and disinfection including infection control procedures;

Staff/personnel safety

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. 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. 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 patient’s 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

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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 hazardous substances and materials to staff, patient and others are identified, assessed, managed and minimised.

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.

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:

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• 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 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

Proper patient privacy Female technician to carry out studies Automatic processors

Ultrasound Proper patient privacy Clean hygienic disposable towel or tissue papers

Bone mineral densitometry The dose reduction devices available on imaging equipment should be active Patient radiation doses should be periodically measured in accordance with technical standards

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MRI Provide reading material to patients to reduce apprehensions.

CT scan Radiation monitoring devices for all technical and staff through DRP/BARC 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

RCS4 Medical Imaging service ensures that the risk of violence and aggression to staff, patient and others are identified, assessed, managed and minimised.

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

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• Corridors should not be used as general storage areas and evacuation routes must always be kept clear.

Section 3

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(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).

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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. Environment protection Act, 1986. 33. 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.

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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. SC and ST Act, 1989 68. 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

Legislation in India: 

 

Atomic Energy Act, 1962  is the basic Nuclear Legislation which provides  for  framing of rules  for ensuring safety  in the use of  ionising radiation  in  India. The Atomic Energy (Radiation Protection) Rules, 2004 which is a revised version of the Radiation Protection Rules, 1971, issued under the Act specify, inter alia, the requirements relating to – 

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• licensing or authorisation, or registration [power to revoke or modify or withdraw the licences]  

• duties of Radiological Safety Officers, their qualifications  

• radiation surveillance procedures to be issued by the Competent Authority  

• powers of Competent Authority regarding inspection of radiation installations, sealing and seizure of devices containing radioactive material and responsibilities of the licensee.    

Chairman,  Atomic  Energy  Regulatory  Board  (AERB)  is  the  Competent  Authority  for  the purpose of implementation of the rules. Surveillance Procedures are  issued under the Rules, by  the Competent Authority  for various radiation installations.  

 

 

Atomic Energy Regulatory Board 

 

  The  Atomic  Energy  Regulatory  Board  has  eminent  individuals  and  senior  government functionaries as its members. The Chairman of the Board heads the executive wing of AERB which has a  large  team  of  scientists  and  engineers with  knowledge  and  experience  in  the  field  of  radiation safety  in nuclear and radiation facilities. AERB  is  financially and administratively  independent of the 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 continuous monitoring of safe operation of nuclear facilities and radiation facilities. Experts from all over the country from governmental and private  institutions are  included  in these committees. The recommendations  of  the  committees  are  forwarded  to  the  Chairman,  AERB  for  consideration  for implementation. Matters of fundamental importance are referred to the apex body, viz., the Board. 

   

Mission  of AERB:  The mission  of AERB  is  to  ensure  that  the  use  of  ionizing  radiation  and nuclear energy in India does not cause undue risk to health and environment. 

 

Functions of AERB: The basic  function of AERB  is  to enforce  rules and  regulations  issued under  the Atomic Energy Act, 1962 for radiation safety in the country. It also enforces rules under the Factories Act, 1948  for  industrial  safety  in  the units under  the  control of  the Department of Atomic Energy (DAE). Detailed functions of of AERB are listed below: 

 

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• Ensure  compliance  by  DAE    and  non‐DAE  installations with  the  safety  codes,  guides  and standards. 

 

• Review operational experience in the light of the radiological and other safety criteria.  

• Review  applications  for  authorization,  commissioning  and  operation  of  DAE  projects  and plants. 

 

• Prescribe acceptable limits of (a) radiation exposure to occupational workers and members of the public and (b) environmental release of radioactive substances. 

 

• Carry out  safety  research and promote  safety  research and development efforts at various academic and research institutions in India. 

 

• Prescribe syllabi for training of personnel in the safety aspects at all levels.  

• Maintain  liaison with other  regulatory bodies  in  India and other  countries  regarding  safety matters. 

 

• Keep the public informed on major issues of radiological safety significance.  

• Review and investigate safety‐related unusual occurrences in respect of radiation generating equipment and radioactive materials in radiation  and nuclear facilities. 

 

• Inspect all nuclear and radiation installations.  

• Prescribe standards for safe disposal of radioactive waste.  

• Maintain inventory of all radioactive material.  

• Prescribe  safety standards for transport of radioactive material.  

• Safety promotional activities.  

• Issue licence to operating personnel  in DAE facilities.  

• Monitor emergency preparedness in all nuclear and radiological facilities. 

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• Develop safety codes, guides and standards.  

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 handling equipment, area and individual monitors and qualification of personnel. Safety Standards for sources  and  a  variety of devices  incorporating  radioactive  sources have been  issued by AERB. The provisions of the Codes, Guides and Standards are enforced by AERB.  

 

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 -

• Type approved equipment  

• Approved facility and installation  

• Radiation (area / individual) monitoring devices  

• Qualified, Trained and Certified manpower  

• Emergency response plans  

 

During the use of radiation sources, specific prior approval of the Competent Authority is required  in respect of  every source replacement, sale, transfer, transport, export and disposal. 

 

 

Regulatory control in three stages: 

 

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Pre‐licensing  :  The  unit  should  be  type‐approved,  the  layout  of  the  installation  should  satisfy  the norms prescribed in the AERB Code, workers should be qualified as prescribed in the AERB Code and regularly monitored.  

 

During use: All  licensees  are  required  to use  the  x‐ray  installation  as per  the  safety procedures  in accordance with  the AERB safety code. Non‐compliance  is a violation. Defaulters can be penalised. Regulatory inspections are conducted  as and when necessary..  

 

After the useful  life of the source: Upon completion of the useful  life of the  installation, the  licensee decommissions the installation and inform AERB about it. The installation should be decommissioned in a manner that it should be not be possible to assemble the parts again and energize the x‐ray unit. 

 

 

Pre‐marketing approval: 

 

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.  

 

Registration and licensing: 

 

  Regulatory consent for working with radiation is issued in the form of registration, or licence. The form of consent is decided on the basis of the radiological hazard associated with the practice.  

 

Registration: The regulatory consent issued to users of radiation sources of relatively low radiological  hazard  is  in  the  form of  registration, e.g. diagnostic X‐ray  installations. Registration of over 40 000 

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installations has been completed. As  for  future users,   suppliers   of  type approved   X‐ray units are  required  to ensure that the users obtain the necessary registration prior to the supply of X‐ray units. 

 

Licensing:  CT  and  Cath  Lab  x‐ray  units  needs  license  as  the  potential  for  exposure  is  higher  as compared to conventional medical x‐ray units..  

 

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. Approval of the  layout of the radiation  installation  is a basic pre‐requisite  in most cases. 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 and guides.  Contravention of these terms and conditions could entail revocation or suspension of the consent. The consentee can appeal against an order revoking a consent.  

 

AERB Safety Code for Medical Diagnostic X‐ray Equipment and Installations  

(AERB/SC/MED – 2)  

 

The safety code deals with: 

1. Safety specifications for medical diagnostic X‐ray equipment and protective devices (X‐ray tube housing leakage – should not exceed 115mR in hour at 1M from the target, Tube filteration‐ up to 70kV : 1.5mmAl, 70 ‐100 kV :2.0mmAl and above 100kV: 2.5 mm Al , Dental cones – 50‐60 kV: 10cm, 60‐75 kV :20cm, above 75 kV :30cm etc.) 

2. Room Layout for an X‐ray installation (general purpose radiography including fluoroscopy – 18 sq. meters and CT and Cath lab units 25 sq. meters, walls should be minimum of 23cm of brick, doors are lead lined , preferably single entry) 

3. Radiation protection and work practice (Crowding of patients should be avoided, assistance to patients during x‐ray exposure by relatives and not by the operator, use of protective devices)  

4. Personnel requirements and responsibilities (Qualified radiographer, radiologist, service engineer) 

 

Responsibilities of the owner of the X‐ray unit: 

 

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a. Get the layout plan approved by AERB b. Installing type approved unit c. Registration/license  of unit with AERB d. Employ qualified staff e. Provide personnel monitoring badges to radiation workers f. Carrying out periodic quality assurance tests of X‐ray units g. Comply with all the relevant rules and regulations 

 

Responsibility of the Manufacturer / suppliers of X‐ray units: 

a. Install only type approved units only after the plan is approved by AERB b. Conduct the performance test of the X‐ray unit  prior to handing over to the user c. Give a copy of the performance test report to user for records 

 

Regulatory inspections 

 

  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 associated with a practice. 

 

Quality Assurance 

 

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.  

(ANNEXURE‐3)  

GLOSSARY OF TERMS 

• Adult. An individual who has capacity and is at least 18 years of age.

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• 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 individual’s 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, mouth–to–mouth 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 individual’s agent, guardian, or

surrogate, to have primary responsibility for the individual’s 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 individual’s 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 patient’s health care decision-maker is

one of the following: the patient’s health care agent as specified in an advance directive, the patient’s court-appointed guardian or conservator with health care decision-making authority, the patient’s 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 patient’s 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.

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• 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 patient’s 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.