A presentation on Planning of Nuclear Medicine facility and regulatory requirements as a prerequisite.

1. Dr.Mustafeed Uddin,
Junior Resident,
Dept. of Hospital Administration,
NIMS

2.  Introduction to Nuclear medicine
 How is it different from radiology & imageology ?
 Applications of Nuclear medicine
 Categories of Nuclear medicine labs
 Planning of Nuclear Medicine Unit
 Radioactive waste disposal
 Personnel
 Radiation protection
 Radiation Safety

3.  Process where in an unstable nuclide
emits charged particles or EMR to attain a
stable state.
 This could last from picoseconds to longer
times resulting in more emissions (m)
 Units of radioactivity
Curie , Becquerel (SI)
measure the r.a decay as dps or cps

4. Nuclear medicine is concerned with diagnostic
and therapeutic uses of artificially produced
radioisotopes.
Nuclear medicine procedures are of two types:
1. In-vivo procedures in which radioisotopes are
administered to patients, and
2. In-vitro procedures where radioactivity is
added to the samples collected from the
patient.
Again, in-vivo tests are classified into:
(a) imaging procedures, and
(b) non-imaging procedures.

5. An imaging procedure,
which is more
popularly known as
scintigraphy, provides
an image of the
distribution of
administered
radioactivity in the
organ or tissue of
interest at any given
time.
Non-imaging
procedures are aimed
at measurements of
gross radioactivity in
the organ of interest at
any particular time.
Serial measurements
provide a time-
activity curve

6. -Transmission imaging
- Xrays /sound waves
- Anatomical imaging
- ExcellentResolution
FORM

-Emission imaging
- Radioactivity
- Functional imaging
- Less resolution
FUNCTION
Radiology vs NM

7. (i) imaging of various organs such as thyroid, liver,
brain, bone, kidneys etc.,
(ii) thyroid function studies, and therapy of thyroid
disorders,
(iii) investigations of central nervous system,
(iv) absorption studies in gastroenterology,
(v) nuclear hematology, e.g., blood volume studies,
iron kinetics, etc.,
(vi) renal function studies,
(vii) nuclear cardiology,
(viii) in-vitro studies like radioimmunoassay (RIA) of
various hormones

11. Molecular imaging using short lived
positron emitters tagged to organic
molecules to detect the patho
physiologic abnormalities at cellular
level.
18FDG --- 110min
13NH3(Ammonia) --- 10min
15O --- 2min
82Rb --- 72 sec

12. On the basis of the nature of work carried out and the
facilities required
Category 1: Laboratories performing in-vitro radio assays
with ready to use kits.
Category 2: Laboratories carrying out radio-labeling of
ligands with preparation of kits and using them for in-
vitro radioassays
Category 3: Laboratories performing in-vivo non-imaging
procedures and in-vitro assays
Category 4: As category 3, but also performing in-vivo
static/dynamic imaging procedures .
Radionuclide Therapy: Categories 3 and 4 nuclear
medicine laboratories can also undertake treatment of
thyrotoxicosis with l31I and polycythemia vera with
32P, with a few added facilities.

13. MODEL OF CARE
 The model of care will depend on level of
services provided as defined in the service plan
and the presence or otherwise of PET as a sub-
component of the Nuclear Medicine Unit.
 In large centers, it will be a discrete unit. If
there are only one or two gamma cameras, it
may be a discrete sub-unit of Medical Imaging.

14. LOCATION
 A ground floor site is preferred but if this
cannot be achieved, consideration should be
given to units above, below and adjoining the
proposed location with regard to radiation
shielding requirements, the weight of
equipment and associated shielding and access
for equipment and radioactive isotopes.
 The Unit should not act as a thoroughfare to
other units of the healthcare facility

15. Functional Areas
Reception / Administration
Waiting areas for outpatients and inpatients,
including toilets
patient holding, observation and recovery area
treatment areas including gamma camera
rooms, specialized scanning imaging rooms
(SPECT, PET, PET/CT, bone densitometry), stress
testing facilities
support areas including utilities, staff station
Hot Lab / Radioactive Waste Store
staff areas including offices and amenities

17. A TYPICAL LAYOUT OF A NUCLEAR MEDICINE LABORATORY FOR
DIAGNOSTIC STUDIES (IN‐VIVO) IMAGING) TOTAL AREA =150‐160 SQ. M.
Note: All the walls /partitions of the Nuclear Medicine laboratory should be made of
9” brick or 6” concrete. Fume Hood to be installed; if required
Decontamination Room is optional. The active toilet may be used for personnel
decontamination by providing a shower and wash basin.

18. Fig: A TYPICAL LAYOUT PLAN FOR A 2‐BEDDED ISOLATION WARD FOR
HOSPITALISATION OF PATIENTS TREATED
WITH LARGE DOSE OF I‐131.
Note: All the walls /partitions of the facility should be made of concrete only, the
thickness of which will depend on the area of the room, position of the bed and the
occupancies all around. The ducting line of the fume hood should be shown in the
plan ,Decontamination Room is optional. The active toilet may be used for personnel
decontamination by providing a shower

19. Fig: DUAL DELAY TANK SYSTEM FOR COLLECTION AND SAFE
DISPOSAL OF RADIOACTIVE WASTE FROM ISOLATION WARD
Note: The capacity of the delay tank for a single

20.  PATIENT WAITING
Waiting areas should allow separation of dosed and
un-dosed patients, particularly as some patients
may need to wait for 45 minutes after dosing for
uptake.
It is also preferable to separate dosed patients from
relatives and visitors to the unit which may
include young adults, pregnant women and
children.
Dosed patients should have access to drinking water
and toilet facilities without having to access
general waiting areas.
Outpatients should be separated from inpatients for
privacy reasons with separate entrances

21. GAMMA CAMERA
The gamma camera is a
device used in Nuclear
Medicine to image gamma
radiation emitting
radioisotopes to view and
analyze images of the
human body or the
distribution of medically
injected, inhaled, or
ingested radionuclide
emitting gamma rays,
producing a two
dimensional image.

22. VIEWING AND REPORTING AREA
A dedicated room with dimmable lighting will be
required for viewing and reporting on scans.
Each workstation should accommodate imaging
screens, computers for access to imaging and
patient information systems, writing and
shelving space for reference materials.
The number of reporting stations will depend on
service level, number of scanning rooms and
the staff establishment

23.  HOT LAB / DISPENSARY AND
RADIOACTIVE WASTE STORE
 Radioactive radiopharmaceuticals are stored
and prepared ready for administration to the
patient in the Hot Lab.
 A lead screen barrier is required for the
dispensary area.
 A radioactive waste storage area may also be
incorporated into or adjacent to this space.
 Provide radiation shielding as advised by
AERB Consultants.
 The Waste Store will require a sink and basin
with hands-free taps for hand washing and
equipment decontamination.

24.  Generator produced
99mTc, 68 Ga ,82Rb
 Cyclotron produced
18F,11C,13N,15O
 Reactor produced
131 I , 99Mo,123I,201Tl

25. - Pure Gamma emitter
- Easily available
- 6hrs half life-Low radiation burden
- Flexible chemistry
- No anaphylaxis
Almost 99% of diagnostic work in the NM
departments is with 99mTc labeled tracers

27. 18F
15O
13N
11C
123Iodine
67Ga
111In
PET Isotopes
Electron
capture

28. is a radioactive compound used in
NM , which does not have any
pharmacological effect, bcos in most cases they
are used in tracer amounts
and does not show any dose response relation
ship like conventional drugs

29.  Hot component
- Isotope
99m TECHNITIUM
131Iodine
201 Thallium
67 Gallium
111Indium
123 Iodine
 Cold component
Chemical substances
tagged with isotopes
to study the organ of
interest.
- DTPA-kidneys
- MDP -bones
- S-Colloid-liver
-MAA - lungs
-sestaMIBI-heart/tumor

31.  Delay and decay – short lived radio isotopes
 Dilute and disperse – small quantity
radioactivity
 Concentrate and contain – large quantity
radioactivity

32.  The radionuclides used in nuclear medicine are
mostly short lived, the half life being in the range
from a few hours to a few days.
 Normally, "Tc99 and 131 I are the two major
radionuclides that are used for nuclear medicine
procedures in large quantities.
 Other radionuclides used at relatively low levels of
activities are 5lCr, 57Co, S8Co, S9Fe, 32P and 125I
and a few others. Because of the short half lives,
the disposal of radioactive waste is done by the
simple method of decay and disposal.

33. • Licensed Physician and
Technologist
• Radiation Safety officer
RSO I,II,III
Mandatory

34. ALARA – As Low As Reasonably Achievable

35. Please inform the doctor if you are pregnant or breast feeding
यदि आप गर्भवती है या स्तनपान कर रहे हैं तो डॉक्टर को ूचितत करं
‫مہربانی‬ ‫براہ‬ ‫کریں‬ ‫مطلع‬ ‫کو‬ ‫ڈاکٹر‬ ‫تو‬ ‫ہو‬ ‫والی‬ ‫پالنے‬ ‫دودھ‬ ‫یا‬ ‫ہیں‬ ‫حاملہ‬ ‫آپ‬ ‫اگر‬
మీరు గరభవతి లేదా బిడ్డకు పాలు ఇస్త
ు నట్ల యితే డాకటర్ కు తెలియ చేయండి
CAUTION

36. Avoid Contamination
Wear gloves, use tissue paper
De -contaminate when necessary
Reduce exposure
Time, Distance, Shielding

37. sheilding

38. BIOGRAPH-16
SIEMENS BIOGRAPH-16
Functional & Anatomical
Imaging

39. 1.5 cm infiltrating ductal CA
Very dense breasts
Negative mammogram
PET/CT for initial staging
COMPREHENSIVE METASTATIC WORKUP
Primary
Liver lesions
Vertebral body

40.  Introduction
 Site & Layout Plan
approval
 Submission of
regulatory consent
form
 Pre-commissioning
Inspection
 Approval of
commissioning/Routin
e Operation
 Work practice
 Waste Disposal
 Radiation Protection
aspects
 Shielding calculations
 Personnel monitoring
devices
 Radiation safety issues
 Operating suggestion
 Personnel monitoring
services for staff
members
 Radiation monitoring
devices
 Staff requirement

41.  Presently, every well-established hospital
would like to procure Medical Cyclotron or
positron emission tomography-computed
tomography (PETCT) facility in their NM
department.
 The various stages of approval of PET-CT
facility by the Atomic Energy Regulatory Board
(AERB) and important steps that one has to
know/follow before planning for this new
facility are summarized in the following
sections

42.  The user has to submit to AERB two copies
each of the proposed layout plan, site plan, and
elevation drawing of the facility indicating the
floor, nature of occupancy around, above and
below, if any, has to be submitted in “B3” size
paper (353×500 mm2) along with the
application form AERB/RSD/NMF/SLA
(downloadable from www.aerb.gov.in). The
user has to clearly indicate the dimension of
each of the rooms associated with the facility in
the proposed layout plan of the NM
department.

44. The user has to submit the details of the completion
of the construction work as per the approved plan,
installation of equipments, procurement of
radiologic protection accessories, enrollment of
radiation workers in Personal Monitoring Services
and availability of qualified staff as per AERB
Safety Code AERB/SC/MED-IV (Rev-1 2001),
shall be intimated to Head, RSD, AERB, by
submitting the Regulatory Consent form no.
AERB/444-NM/RC-FORM (downloadable from
www.aerb.gov. in)

45.  In this stage, the precommissioning inspection
of the facility will be carried out by AERB
official(s) to ensure that the construction of NM
facility is as per the approved plan and also to
verify the information provided in stage “2”
mentioned above

46.  On ensuring the compliance of the requirement
as specified in AERB safety Code SC/MED-IV
(Rev.1. 2001) for the safe handling of
radioactive material in the approved NM
facility, the authorization for the procurement
of radioactive material indigenously or no
objection certificate (NOC) for procurement of
radioactive material from abroad will be issued
for the stipulated time period.

47.  In NM facility, the radiopharmaceutic
formulation should be prepared, handled,
administered to the patients, and disposed of in
a safe manner taking into account adequate
radiation protection measures
 Radioisotopes should be stored, used, and
transported safely and securely all the time.
Any unusual event that has resulted or has the
potential to result in overexposure to the
workers or public should be reported to the
AERB.

48.  In India, radioactive waste management is
governed by the Atomic Energy (Safe Disposal
of Radioactive Wastes) Rules, 1987, GSR-125
issued under the Atomic Energy Act, 1962.
 In NM, having PET-CT facility, mostly short-
lived radioisotopes C-11, N-13, O-15, F-18, and
others are used in unsealed form. The half-lives
of these radioisotopes range from few minutes
to few hours
 There are 2 main approaches to the disposal of
radioactive waste. One is characterized as
“dilute and disperse” and the other as “confine
and contain.”

49.  NM facility with PET-CT employs relatively
large activities of high-energy photon emitting
radioisotopes. This coupled with the current
dose limits for members of the public, can
result in a shielding requirement.
 Even modest reductions in the radiation levels
at 511 keV require significant amounts of
shielding.
 A thorough and site-specific evaluation has to
be made for each facility

50.  Determine the expected workload (number of
patients per week) of the facility, maximum
radioactivity to be administered per procedure,
and CT workload (total mAs and kVp) per patient.
 Determine the occupancies of areas within the
facility and in adjacent, uncontrolled areas. Include
consideration of occupancies at floors above and
below the facility.
 Determine the location of the place where all the
initial activities of radioisotopes are to be
dispensed. This also includes the injected patient
working area.
 Obtain the isodose curves of the transmission
sources in a PET-CT scanner

51.  Automated dose dispenser
 Dose calibrator with thick lead shielding to reduce
technologist exposure
 Tungsten syringe shields to reduce finger dose
 Extra thick L-block table-top shields (5 cm of lead
compared with 1.2 cm of lead in standard NM
applications)
 Syringe carriers for transporting the dose from one
room to another
 Remotely actuated syringes that keep the syringe
totally enclosed in a shield while the operator
delivers the dose by pushing on an extension rod

52.  Maximize separation from the patient after
injection and minimize the time spent with
them
 If the patient is ambulatory, allow as much
separation as feasible when they are escorted to
the scanner room
 In the hot laboratory, particular attention
should be paid to minimize the time required
to handle the dose during the assay and
verification steps

53.  Every staff member, involved in radioactive work, such as
radiopharmacy, radiochemistry, dispensing of radioactivity,
radiopharmaceutic dose administration, patient imaging,
and others, should be covered with personnel monitoring
services.
 For availing this facility, one may approach the Head, CD
and R Section, RP and AD, BARC, Anushakti Nagar,
Mumbai.
Presently, 3 such laboratories are accredited as given below.
1. M/s Avanttech Laboratories (P) Ltd.
# 76, 7th Street, Ground Floor, Porur Garden, Phase – I,
Chennai – 600 095.
2. M/s Renentech Laboratories Pvt. Ltd.
C-106, Synthofine Industrial Estate,Off Aarey Road, Goregaon
(E) Mumbai – 40 063.
3. M/s Ultratech Laboratories Pvt. Ltd. 12/15, Priyadarshini,
Parisar (W) Bhilai, C.G. - 490020.

54. In the NM department having the Medical
Cyclotron and PET facilities, following are the
monitoring equipments required:
 GM-based survey meter/ionization chamber–
based survey meter
 Contamination monitor
 Pocket dosimeters
 Isotope dose calibrator

55.  Since the quantity of radionuclide that is being
handled is significant and the energy of
associated radiation is high,
 It is absolutely necessary to have an automatic
smaller dosage dispensing unit, fume hood,
and L-Bench to handle smaller dose for quality
assurance tests, lead bricks, shielding devices
made of tungsten (syringe shield, source
container, transport container, and others),
remote handling devices (de-capper, cap sealer,
long vial holder, pair of tongs, and others.

56.  Nuclear medicine physician : MBBS plus
A post graduate degree/diploma in NM
recognized by the Medical Council of India or
National Board of Examination.
 Nuclear medicine technologist Qualifications :
A Bachelor’s degree in NM technology from a
university; or
A Bachelor’s degree in Science from a university;
and Bachelor degree/Post graduate
degree/diploma in NM technology from a
university

57.  Radiological safety officer :A candidate with the
following qualification is eligible to appear in the
RSO Certification Examination conducted by the
AERB.
Qualifications for RSO Level-II
A post graduate degree/diploma in Nuclear
Medicine recognized by the Medical Council of
India or National Board of Examination, Ministry
of Health and Family Welfare; Or
A degree/post graduate diploma/post graduate
degree in Nuclear Medicine Technology from an
institution or university

61. Lets use it for the benefit of mankind

62.  Guidelines For Starting A Nuclear Medicine
Laboratory : Excerpts from a booklet published by
Bhabha Atomic Research Centre, India.
 Tandon P. Regulatory requirements for designing
PET-CT facility in India. Indian Journal of Nuclear
Medicine : IJNM : The Official Journal of the Society of
Nuclear Medicine, India. 2010;25(2):39-43.
doi:10.4103/0972-3919.72684.
 Chapter 27, : Indian health Facility Guidelines,2014
 www.aerb.gov.in
 www.barc.gov.in