Radiologydepartment_INTRODUCTION AND PLANING

1. Dr Trupti Sonthalia
MHA-TISS- 10-12
PLANNINGAM
O
D
E
R
NIMAGING
DEP
AR
TMENT
ETHICSANDL
E
G
A
LISSUESin
Radiology

2. • Radiology department is one of the focal point of any hospital or a
medical centre and setting up such a facility requires a very
careful planning and a vision for the future.
• Scope of a modern radiology setup is not only limited to imaging
studies but also has a therapeutic role in the form of minimal
invasive interventional radiology setup.

3. STRATEGIC
PLANNING
• Feasibility of setting up an imaging centre in a given area – 1st step
Need for such services in the given area
Presence of other centres
Status and acceptability of referring physicians
Presence of larger hospitals in area
• Further planning can be undertaken once it is clear that there is a need for the same

4. • 2 types of radiology centres -
Radiology departments in a hospital setting
Dedicated radiology centres, that works on referrals
• Difference – patient referral

5. LOCATIO
N
• Preferably on the ground floor
• Sophisticated machines like CT and MRI are best placed on the ground floor
• In addition to walk in patients, the department also caters to emergency patients
who may not be able to walk or need urgent scanning for establishing the
diagnosis
• Should be easily accessible to
• OPD patients,
• inpatients
• emergency department.

6. GROUND FLOOR
EMERGENCY OPD
TSH

7. EQUIPMENT
S
• Digital X-rays
• Fluoroscopy units
• Mammography unit
• Dual energy X-ray absorptiometry (DEXA) unit
• Ultrasonography units
• Multislice CT
• 1.5 T/3 T MRI
• Digital subtraction angiography unit
• Positron emission tomography – computed tomography (PET-CT)

8. MRI
PET / CT
MAMOGRAPHY
XRAY/FLURO DEXA
USG USG
USG
RECEPTION
DSA
REPORTING ROOM
CHANGING / TOILET
HANGING / TOILET

9. LAYOU
T
• Reception area
• Preprocedural and changing rooms
• Investigation rooms
• Reporting room

10. CHANGING / TOILET
HANGING / TOILET
MRI
PET / CT
MAMOGRAPHY
XRAY/FLURO DEXA
USG USG
USG
RECEPTION
DSA
REPORTING ROOM

12. RECEPTION AREA
• Patient entering should immediately know where
to go /approach
• Well lit,
• adequate space for
• sitting
• trolleys and wheel chairs
• Person-in-charge 
• qualified and well versed with various types of
radiological studies;
• prime responsibility of scheduling the studies for the
patients
RECEPTION

13. PREPROCEDURE AND CHANGING
ROOMS
• Nearly every radiological investigation needs some type of
preparation
• To remove any metallic clips or rings for X-rays
• Changing into hospital gown
• Screening for any metallic item on the patient before MRI

14. INVESTIGATION
ROOMS
• A modern radiological setup should have minimum of
1. one digital X-ray unit,
2. one fluoroscopic unit and
3. one mammographic unit,
4. one sonographic unit,
5. one CT scan,
6. one MRI unit
• X-ray, fluoroscopic and CT scan emit ionising radiation  special
care required for construction of rooms

15. AMENDMENT TO AERB SAFETY CODE FOR MEDICAL
DIAGNOSTIC X- RAY EQUIPMENT AND INSTALLATIONS,
[CODE NO. AERB/SC/MED-2, (REV.01), 2001]
Sr. No. Section Requirement
1 1.1, 1.2, 6.10 Reference of AE(RP) R-2004
2 3.1 Location of X-Ray Installation
3 3.3, 3.4 Room size and shielding
4 3.7 Control Panel
5 3.10 Dark Room
6 4.5 Mobile Equipment
7 5.1.1 Safety Personnel
8 5.1.2 Radiologist
9 5.1.3 X-ray Technologist
10 5.1.4 Service Engineer
11 5.2.1 Responsibilities of Manufacturer
12 6.2 Type Approval/No Objection Certificate
13 6.3, 6.5 Approval of Layout, Operation of X-ray equipment
14 Appendix II The X-Radiation Warning Sign
15 6.11 and 6.12 Regulatory Controls: New Sections to be added for Licence and
Authorization
16 Appendix IV
, V
,VI and VII Application Form Formats

16.  Location of X-Ray Installation
Rooms, housing diagnostic X-ray units and related equipment, shall 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.
If the installation is located in a residential complex, it shall be ensured that –
Wall(s) of the X-ray rooms on which
1. primary X-ray beam falls is (are) not </= 35 cm thick brick
2. scattered X-ray fall is (are) not </= 23 cm thick brick
door(s) and windows of the X-ray room
1. Shielding equivalent to at least 23 cm thick brick or 1.7 mm lead in front

17. Room size and shielding
appropriate area to facilitate easy movement of staff and patient positioning.

Appropriate structural shielding shall be provided for walls, doors, ceiling and floor of
the room
doses received by workers/public are should not exceed the respective annual effective
doses
dark room to ensure that the undeveloped X-ray films are not exposed to more than
10 μGy per week.
The room shall not be less than 18 m2 for general purpose radiography and conventional
fluoroscopy equipment.
Also, not more than one unit of any type shall be installed in the same room, and no
single dimension of these x-ray rooms shall be less than 4 m.

18. >4m
>18m2
Single unit
XRAY/FLURO
>4m

19. Control Panel
In case of room housing general purpose radiography and fluoroscopy equipment, chest
stand shall be located in x-ray room such that no significant stray radiation reaches at
control console/entrance door.
The control panel of diagnostic x-ray equipment operating at 125 kVp or above shall be
installed in a separate room located outside but contiguous to the x-ray room and
provided with appropriate shielding, direct viewing and oral communication facilities
between the operator and the patient.
In case of x-ray equipment operating up to 125 kVp, the control panel can be located in
the x-ray room. The distance between the control panel and the x-ray unit/chest stand
shall not be less than 3 m.

20. XRAY/FLURO <125KVp XRAY- = 125KVp
>3m

21. DARK
ROOM
• Made completely dark and normal light is
excluded to allow the processing of X-ray films
• Door systems –
• single/double door,
• maze type,
• revolving type
• Equipments used –
• Processing tanks,
• cassettes,
• safelight,
• hangers and
• automatic processors
The dark room shall be located such that
no significant primary or secondary x-
rays reach inside the dark room.
2m
2.6m
15cm thick
WET DRY
SINK
1.2m

22. • Floor area not less than 2.6x2m
• Room made completely lightproof
• Should not be damp or subjected to
extreme of temperature
• Water and electrical outlets provided
• Sufficient space to accommodate a
dry bench (3x2), a wet bench and a
sink.
• Should be near the x-ray examination
area
• Walls of solid concrete (15cm thick)
• Lead box inside to store boxes of
unexposed films

23. Processing Tanks
 Developer,
 rinsing,
 fixer and
 washing
Made of stainless
steel to avoid erosion
1 to 10 gallon
Cassettes
Used to hold the X-
ray film and
intensifying
screens
Excludes all light
from entering the
cassette
Safelight
Lamp used which
doesn’t affect the X-
ray film processing
Gives sufficient light to
facilitate work
Must be atleast 1.2m
above the work area

24. HANGE
RS
Instrument or device for holding radiographic
film during processing procedure
Made of stainless steel
Clip, channel and spring types
Automatic processor
Fast efficient method for processing film
Developer
,
fixer,
washing,
dryer
Contains rollers instead of rinsing

25. PASS BOX
•Cassette Transfer Cabinet – allows
cassettes to be transferred to and from the darkroom
without the worry of light or radiation entering.
Extra heavy duty constructions
with
1. double light and radiation traps,
2. welded doors (2)
WET DRY
SINK

26. Mobile Equipment
Movement of mobile x-ray equipment shall be restricted within the
institution for which it is registered.
The distance between operator and x-ray equipment shall not be less
than 2 m during exposure.
Operator shall always use radiation protection devices such as
protective apron while operating the x-ray equipment.
Fluoroscopy shall not be carried out with mobile equipment.
>2M
AJH
RC
X
R
A
YP
O
R
TA
B
L
E
NO FLUROSCOPY

27. Safety Personnel
Every X-ray department shall have a Radiological Safety Officer (RSO) having
qualifications as prescribed and approved by the competent authority from time to
time.
The RSO has responsibility of ensuring compliance with appropriate radiation
safety/regulatory requirements applicable to his/her X-ray installation

28. Radiologist
All installations having x-ray unit with fluoroscopy facility, and all establishments
performing special procedures, shall have the services of a qualified radiologist or
related medical practitioner, with adequate knowledge of radiation protection
for interpretation and reporting.
X-ray Technologist
All x-ray installations shall have a radiologist/related medical practitioner or a qualified x-
ray technologist, with adequate knowledge of radiation protection, to operate the x-ray
unit.
Service Engineer
All manufacturers, suppliers and service agencies of diagnostic x-ray equipment shall
have qualified service engineers for
 installation,
 servicing and
 maintenance of the equipment.

29. Responsibilities
of
Manufacturer

30. PRIOR
LICENCE
FOR COMMERSIAL PRODUCTION
IMPORT PERMISSION
FOR XRAY TUBES AND INSERTS
TYPE APPROVALCERTIFICATE
Prototype of every model of equipment
DATA
of testing of x-ray tubes andequipment
INSPECTION
shall make premises available
Responsible for ensuring compliance with terms and conditions of Licence and Type Approval.

31. Responsibilities of
Supplier of
x-ray equipment

32. N
FROM THE
COMPETENT
AUTHORITY
NOC FOR IMPORT
TYPE APPROVALCERTIFICATE
demostrate
Responsible for ensuring compliance with terms and conditions of Authorisation and type approval
market equipment of foreign make
type approved diagnostic x-ray equipment ,
1. installation ,
2. commissioning ,
3. acceptance testing/quality
4. servicing and maintenance (life-time)
supply of radiation protection devices
1. protective barrier,
2. protective apron,
3. lead rubber flaps etc.
Responsible for

34. Type Approval/ No Objection Certificate
Prior to marketing the x-ray equipment, the manufacturer/local supplier of
imported equipment shall obtain a Type Approval Certificate from the
competent authority, on demonstration of performance of the prototype of
x-ray equipment.
Import of prototype of x-ray equipment, meant for Type Approval, shallbe
carried out by the local supplier only after obtaining NOC for import for
Type Approval, from the competent authority.
Type Approval/NOC will be issued only if the equipment satisfies the safety
specifications of this Code and the standards in force.
Import of every Type Approved x-ray machine by supplier or any other
importing agency, shall be carried out only after obtaining NOC for import
of x-ray equipment, from the competent authority.
Only type-approved and NOC-validated equipment shall be marketed and
used in the country.
For import of x-ray tube(s), the importing agency shall obtain NOC for
import of x-ray tubes from the competent authority.

35. TYPE APPROVAL CERTIFICATE
Prototype of every model of equipment
MANUFACTURER /
LOCAL SUPPLIER
NOC FOR
IMPORT
IMPORTING AGENCY
Type Approval/NOC will be issued only if the equipment satisfies the safety specifications of this Code and the
standards in force.
marketing the x-ray equipment

36. Approval of Layout
No x-ray unit shall be commissioned unless the layout of the
proposed x-ray installation is approved by the competent authority.
Operation of X-ray equipment: No diagnostic x-ray equipment shall
be operated unless licensee obtains license and/or registration from
the competent authority.
A modern radiological setup should have minimum of
 one digital X-ray unit,
 one sonographic unit,
 one mammographic unit,
 one CT scan,
 one fluoroscopic unit and
 one MRI unit
X-ray, fluoroscopic and CT scan emit ionising radiation  special care
required for construction of rooms

37. Radiation Sign

38. STANDARD LAYOUT OF X-RAY
INSTALLATION

39. 450 cm
400
cm
23CM THICK
BRICK
Column Center
Spot film device
Unit Electronics
MPB with lead glass viewing window of
1.7 mm lead equivalence
Examination table
X-ray
Tube
Column Stand
Chest Stand
Control Unit

40. RADIATION STANDARDS
Type of
Equipment
Applied
voltage (kV)
Applied
Current (mA)
Exposure time
(sec)
Workload(mA-
min/week)
Radiography and
Fluoroscopy
80-100 50-100 1-2 500
Mammography 30-35 100-200 1-2 300
Computed
Tomography
110-140 50-100 1-2 25000
Interventional
Radiology
80-100 50-100 1-2 5000

41. STANDARD LAYOUT OF CT
INSTALLATION

42. COMPUTED TOMOGRAPHY ROOM
• The size of the room housing the gantry of the CT unit shall not be
less than 25m2.
• The control panel of CT shall be installed in a separate room
located outside but adjoining to CT room and provided with
• appropriate shielding,
• direct viewing and
• oral communication
facilities between the operator and the patient.

43. 625C
M
400
cm 23cm thick brick 200cm
Unit
Electronics
EXAMINATION TABLE
Viewing Glass
100 cm X 80 cm of
2.0 mm lead equivalenc
> 25m2
Hemachandra SIR

44. STANDARD LAYOUT OF INTERVENTIONAL
RADIOLOGY INSTALLATION

45. 500C
M
500
cm 23cm thick brick 200cm
Unit
Electronics
CArm
Fixed
radiation
shield
EXAMINATION TABLE
Viewing Glass
120 cm X 100 cm of
2.0 mm lead equivalenc

46. STANDARD LAYOUT OF MAMMOGRAPHY
INSTALLATION

47. 350 cm
300
cm
23CM THICK
BRICK
Unit Electronics
Control Unit
1.5
mm
lead
equivalence
Mammography equipment
Changing
room

48. ULTRASONOGRAPHY ROOM
• Since ultrasound machines do not emit any ionising radiation, it is possible to house
them in a general room without any special construction guidelines.
• A well designed sonography room should have
• ambient light control,
• an examination trolley/bed,
• a changing room and
• a washroom

49. MRI ROOM
• MR machine contains a large magnet, which emits strong magnetic field in all
directions, so its installation and housing is different from any other radiological
equipment.
• An MR unit has to be shielded in such a way that its magnetic field does not exist
outside the room 
• active shielding,
• passive cladding and room shielding are done.
• For patient safety, the access to the MR room should be controlled and clear printed
instructions should be displayed at the point beyond which only patients with
adequate screening can go.

50. MRI ROOM
• In any MR installation, it is necessary to see the effect of emitted magnetic field in
all directions.
• Any device or equipment, which is sensitive to magnetic fields, should be away from
the MR unit or adequately shielded (e.g. Power transformers, CT scanners,
ultrasound equipment, etc.)
• Special planning is done to see that the MR unit is away or well shielded from
• steel pipes and structural steel.
• Since device that RF waves, e.g. cell phones, radio transmitters, etc., can cause
interference in image reconstruction, the MR unit also needs to be shielded from RF
pulses.

51. Unit
Electronics
EXAMINATION TABLE Hemachandra SIR
Structural Steel

52. REPORTING ROOM
• In a modern department, nearly all reporting is done on dedicated workstations.
• Different from conventional setups where first X-ray, CT or MRI images are
printed on films and then send for reporting.
• A filmless setup is
• cheaper,
• environment friendly,
• easier to maintain and useful.
• Big enough to house separate reporting consoles for all radiologists who are
working.
• Their consoles should be independent and at the same time should be
designed in a way that interpersonal communication is not hindered

53. ADVANCES IN RADIOLOGY SETUP
• MOVING TO FILMLESS RADIOLOGY
• Instead of printing films, the images are viewed on monitor for reporting
and then given to patients either in CDS or paper prints or sent to referring
doctors electronically via net to their computers.
• Achieved in two ways –
• Images can be acquired digitally with the use of modern equipment or
• images can be digitalised by scanning the films.
Conventional X-ray images Digital X-ray images
If factors like tube voltage and current are not
optimal, the image on the films may not be useful
 X-ray needs to be repeated, giving patients
additional dose of radiation
The image can be manipulated, even if acquisition
is not optimal  repeat X-ray can be avoided
Storage of films takes a lot of space and can get
degraded with time
Images can be stored very easily for years
together and can be sent electronically to higher
centres for second opinion

54. PACS AND HIS
• For achieving rapid reporting, transfer and storage of images, a system
called PACS is installed.
• PACS – Patient Archiving and Communication System
• The radiology machines are lined to a central server where all the images
are sent. From there, the images are sent for long term storage and also
for reporting to individual workstations of the radiologists.
• PACS is linked to HIS (Hospital Information System) in larger hospital
setups.
• The acquired images can be made available to the referring physicians
very soon after they are acquired. Also, the radiologists have access to the
clinical and laboratory details of the patients, which go a long way in
reaching to a correct diagnosis

55. ETHICSA
N
DL
E
G
A
LISSUES

56. • Radiology is a specialized branch of medicine using medical imaging
technologies to diagnose and treat patients.
• Like other specialties, radiologists are also liable to claims of malpractice
due to diagnostic errors.
• Errors in radiology differ from errors in other clinical specialities as in
that, the radiological image is a permanent objective record that can be
reviewed to check for missed lesions.
• Such errors, when causes significant damages to the patients, in the form
of injury or death, attract malpractice claims.

57. • Apart from the medical malpractice, another important area of
legal importance for Indian radiologists is Pre-conception and Pre-
natal Diagnostic Techniques Act (PCPNDT- Act) which has stringent
rules and regulations to curb female feticide.
• It is important to follow and strictly adhere to the guidelines laid
down under the act to avoid legal actions.

58. MEDICAL MALPRACTICE AND RADIOLOGY
• The term “medical malpractice” refers to the professional negligence of doctors,
surgeons, nurses and other healthcare professionals. This is the most common
complaint registered against a doctor.
• Medical malpractice is said to have occurred when the healthcare professional
discharged a substandard level of care and, as a result of which the patient
suffered damages.
• The three essential components to prove medical malpractice lawsuits are
• breach of duty,
• causation and
• resulting damage.

59. • Radiologic errors in diagnosis can be of two types,
1. cognitive and
2. perceptual errors.
• Cognitive errors are those in which an abnormality is seen but its nature is misinterpreted.
• Perceptual errors or the radiologic ‘miss’, are the one in which a radiologic abnormality is not
seen by the radiologist on initial interpretation.
• Of the two types, perceptual errors resulting in false-negative errors are the most frequent
accounting for 80% and the majority of which includes failure to diagnose
• breast cancer on mammography,
• lung nodules on chest x-ray and
• fractures on skeletal radiographs.

60. • Not all missed findings represent the breach in standard of care.
• When the radiologist reviews an imaging study obtained with
• proper technique and exposure and fails to perceive an abnormality, which, in retrospect, is
apparent, such ‘error in perception’ cannot be labelled negligence.

61. • Other infrequent causes –
Failure to alert or communicate with the referring clinicians of important but
unsuspected findings
Failure on the part of the radiologist to suggest appropriate next procedure when
diagnostic specificity is required
Incorrect examinations obtained on patients
• Once a person claims a malpractice who is referred to as ‘plaintiff’, should establish the
existence of all the three elements of malpractice i.e.
• breach of duty,
• causation and
• damages.
• If any one element is missing, then the malpractice claim is not valid.

62. Radiologist as a defendant in malpractice claim:
• Do not panic or lose confidence when a malpractice is claimed. One
should act calmly.
• On receiving such court notice, the document should be read carefully
to determine the nature of claim.
• Later, assemble all the related documents i.e. physician referral
form, consent form, acquired images, reports etc.
• Do not alter any medical records.
• Immediately contact the medical defense lawyer and insurer.
• An investigation committee will be formed which includes renowned
and senior doctors who are experts in the particular discipline.
• Depending on the committee opinion, if the radiologist is proved
negligent, necessary action will be taken up according to the nature
of act.

63. In Indian Law, doctors can be held responsible under:
• Civil suit consumer court: Consumer protection act (CPA) considers
patient seeking medical care as ‘consumer’ and doctors attending to
it as ‘service provider’. Doctor-patient relationship/contract is
bound to CPA.
• Case in medical council: A case against a doctor can also be filed in
medical council of the concerned system of medicine. Medical
Councils do not have powers to award compensation or to imprison.
It can only warn the doctor, suspend or revoke the license.
• Case of criminal negligence: The main section under which a criminal
case is filed against doctors is Section 304A of the Indian Penal Code
which deals with causing death due to rash and negligent act. The
punishment is two years imprisonment or fine or both.
• Law of Torts

64. • “The standard to be applied for judging, whether the person charged has been
negligent or not, would be that of an ordinary competent person exercising
ordinary skill in that profession.
• It is not possible for every professional to possess the highest level of expertise or
skills in that branch which he practices.
• A highly skilled professional may be possessed of better qualities, but that cannot
be made the basis or the yardstick for judging the performance of the
professional proceeded against on indictment of negligence.”

65. • In order to protect oneself from malpractice litigation, following points
should be remembered:
Always consider the clinical history viz, history of presenting illness,
past history and occupational and drug history. If more information is
needed, contact the referring physician directly.
Develop good rapport with the patient.
To obtain written informed consent after explaining the risks and
benefits of the imaging procedure. Explain the limitations associated
and available alternatives, if any.
To confirm that the patient is subjected to the test requested and
follow ALARA principle to limit the radiation exposure.
Date and time of the examination should be documented. Regular
check on the computer clocks to be done to avoid out of
synchronization with the actual date and time.
Follow the recommended standard protocols to image the anatomic
structure.

66. To obtain satisfactory image if the initial image quality is not
adequate for interpretation.
Consider additional views if necessary.
Systematically evaluate the images so that the lesions do not go
unnoticed.
Always consider and compare previous imaging study if available.
Do not jump into conclusion or get biased with the previous report.
Document the noted abnormality in the report and reach a
conclusion.
Proofread the report. Correct the typographical errors. This written
report determines whether the radiologic standard of care is
conformed to or breached, once a malpractice lawsuit is filed.
Suggest further appropriate next step to increase diagnostic
specificity, if required.

67. Communicate with the referring physician when important unsuspected finding is
noted that which require immediate management.
While examining female patients, male radiologists should ensure that the
examination is carried out in the presence of female attendant.
When the radiologist feel that he is not expertise in the diagnostic or interventional
procedure requested, consider seeking the help or referral to another colleague.
Radiologists should regularly get updated with the new technologies and current
practice guidelines.

68. CONSENT IN RADIOLOGY PRACTICE
1. Two main indications or instances where consent is necessary in the
daily radiology practice are before
1. administering an intravenous contrast and
2. before performing any interventional procedures.
• Common meaning of consent is permission whereas the law perceives it
as a contract i.e. an agreement enforceable by law.
• In consent, there are four separate but correlated elements that are:
Voluntariness
Capacity
Knowledge and
Decision-making

69. CONSENT IN RADIOLOGY PRACTICE
• It can be either implied or expressed (oral or written).
• Expressed consent includes informed consent, which is the ideal
form of consent because it includes all aspects of meaningful
decision-making.
• Informed consent provides the comprehensive information to
patients on the imaging procedure to be performed which includes
both advantages and potential risks and complications.
• Standard hospital consent forms will not be considered as consent
for diagnostic procedure or therapeutic treatment.

70. TO OBTAIN A LEGALLY VALID CONSENT
Comprehensive consent form should enable balanced judgment by the patient and his/her
relative by explaining the procedure, its risks and benefits, as well as any alternatives if
available.
The signature or thumb impression of the patient must be taken.
In case of legally incompetent patient, the family of the patient becomes the decision
maker. Spouses’ decision is considered the most important, followed by immediate relatives
such as parents, children, and siblings.
No changes can be made in the form thereafter. Such an attempt raises the possibility of
suspicion.
Preserve the document in the departmental records.

71. PRE-CONCEPTION AND PRE-NATAL
DIAGNOSTIC TECHNIQUES ACT (PCPNDTACT)
• A national law, Pre-natal Diagnostic Techniques (Regulation and Prevention of
Misuse) Act (PNDT Act), 1994 was enacted to prevent sex determination and
came into force on January 1st, 1996.
• In the meantime, new techniques had been developed that used pre-conception
or during conception sex selection. To bring these new technologies under the
purview of the Act, the law was amended in 2003 and is renamed the Pre-
conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Act
(PCPNDT Act), (effective from February 14, 2003).
• Despite the enactment of the Act in 1996 with subsequent amendment in 2003,
the decline in Child Sex Ratio (CSR) from 927 girls per 1000 boys in 2001 to 914 in
2011 was evident, reflecting the continued practice of sex selection.
• Hence, the Act was again amended in 2012 with steps towards stronger, rigorous
and effective implementation of the Act.

72. PRE-CONCEPTION AND PRE-NATAL
DIAGNOSTIC TECHNIQUES ACT (PCPNDTACT)
• Why this act?
An Act to provide for the regulation of the use of pre-natal diagnostic
techniques for the purpose of detecting genetic or metabolic
disorders or chromosomal abnormalities or certain congenital
malformations or sex linked disorders and for the prevention of the
misuse of such techniques for the purpose of pre-natal sex
determination leading to female feticide; and, for matters
connected there with or incidental thereto.
This act regulates genetic counseling centers, genetic laboratories
and genetic clinics (used for conducting pre-natal diagnostic
procedures). Use of ultrasound comes under Genetic Clinic.

73. WHO CAN SET UP A GENETICCLINIC?
• Any person having adequate space and being or employing a Gynecologist having
experience of performing at least 20 procedures in chorionic villi aspirations per
vagina or per abdomen, chorionic villi biopsy, amniocentesis, cordocentesis,
fetoscopy, fetal skin or organ biopsy or fetal blood sampling etc. under supervision
of an experienced
• gynecologist in these fields, or
• a Sonologist, Imaging Specialist, Radiologist or
• Registered Medical Practitioner having post graduate degree or diploma or
• six months training or one year experience in sonography or image scanning, or
• a medical geneticist.

74. GUIDELINES FOR THE USE OF ULTRASOUND IN
GENETIC CLINIC
• Centers where ultrasound is intended to be carried out should get registered, at least 30 days in
advance.
• All ultrasound machines available at that center along with the qualified doctors performing USG
should be registered on the certificate.
• No doctor other than the one registered in the particular centre is allowed to use themachine.
• In the case of a locum doctor, the doctor’s name and personal details, state council registration
number, and his/her degree certificate need to be sent to the appropriate authority (AA)/ward
office, requesting permission for the use of the machine by the locum on the specifieddates.
• The USG machine should not be shifted from one Centre to another.

75. • Any changes in the center (e.g., change in machine or place of use) should be
intimated 30 days in advance of the expected date of such change.
• Portable ultrasound machines should be used as a part of the registered mobile
medical unit, offering other health and medical services. It cannot be used in a
vehicle not registered under the Act.
• Registration and practice of sonography by a radiologist/ sonologist is restricted to
two clinics/facilities within a district. The consulting hours by such medical
practitioner should be specified by each clinic/centre.
• Renew the certificate of registration every five years, with application of renewal
being applied 30 days before the date of expiry to the AA.
• A copy of PC-PNDT registration certificate should be displayed in reception area and
the USG room.

76. • A copy of PC-PNDT Act booklet should be made available in both the waiting room and USG
ROOM.
• Sign in English and in the local language must be displayed, indicating that FETAL SEX IS
NOT DISCLOSED IN THE CLINIC.
• Form F must be filled completely. The signed consent of the patient as well as the
radiologist signature who performed the procedure should be obtained. A hard copy with
patient signature has to be preserved at the clinic when form ‘F’ is submitted online.

77. • A monthly report should be submitted to the AA regularly, before the 5th of every
month.
• All the records need to be maintained for a minimum of 2 years. If there is any
legal proceeding pending in court of law, then these records should not be destroyed
till the proceedings have been disposed off.
• Advertisement and communication of sex selection is strictly prohibited under the
act.