Ethiopian Standards

Nuclear Medicine Services Requirements

May, 2022

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Table of Contents
List of Abbreviations..................................................................................................................................1
1. Description.........................................................................................................................................2
2. Practice...............................................................................................................................................3
3. Radiopharmacy/Nuclear Pharmacy...............................................................................................13
4. Premises(Facilities )........................................................................................................................15
5. Professional......................................................................................................................................23
6. Products(Equipment ).....................................................................................................................24
7. Quality control..................................................................................................................................26
8. Records (Documentation)...............................................................................................................28
9. RIA/IRMA.........................................................................................................................................30
10. Radioactive iodine therapy for thyroid diseases........................................................................31
11. Workflow in Nuclear Medicine facility.......................................................................................32
12. References....................................................................................................................................32

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List of Abbreviations

CT Computed Tomography

EFDA Ethiopian Food and Drug Administration

ERPA Ethiopian Radiation Protection Authority

IAEA International Atomic Energy Agency

IRMA Immuno-Radiometric Assay

MRI Magnetic Resonance Imaging

NEMA National Electrical Manufacturers Association

NIST National Institute of Standards and Technology

NM Nuclear Medicine

PEC Primary Engineering Control

PET Positron Emission Tomography

PPE Personal Protective Equipment

QC Quality Control

RIA Radioimmunoassay

SOPs Standard Operating Procedures

SPECT Single Photon Emission Computed Tomography

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1. Description

1.1. Nuclear medicine, including PET, is the specialty of medicine which employs
unsealed sources of radionuclide (radiopharmaceuticals or tracer) for diagnosis
and therapy.
1.2. Nuclear medicine studies primarily show the physiological function of the system
or organ being investigated using radiopharmaceuticals as opposed to the anatomy
as is the case with radiology.
1.3. Increasingly, nuclear medicine images are being superimposed on appropriately
registered images from modalities such as CT or MRI. This is known as image co-
registration or hybrid imaging and is performed to further highlight the part of the
body the radiopharmaceutical is concentrated.
1.4. Nuclear medicine imaging works by administrating radiopharmaceuticals to the
patient. In a normal organ, the radiopharmaceutical will have characteristic uptake,
clearance or distribution. Organs not functioning normally will have variations on
these characteristics and therefore indicate potential disease. The gamma camera
detects the rays and using computer processing, images and functional assessments
of organs and tissues are produced.
1.5. Nuclear medicine services may or may not include a Radiopharmacy laboratory (if
radiopharmaceuticals dose is supplied from a Centralized Radiopharmacies) and a
PET suite. The size of a Unit in terms of numbers and type of gamma cameras will
be determined by clinical needs.
1.6. Therapeutic procedures may include treatment for an overactive thyroid
(hyperthyroidism) or thyroid tumors using radioactive Iodine -131. Some nuclear
medicine therapies require inpatient admission.
1.7. Other radionuclide therapies can be administered to patients as a day procedure.
This distinction relates to the characteristics of the therapy radionuclide utilized,
and the radiation hazard they pose to the public when discharged. In therapeutic
nuclear medicine, the radionuclides used often differ from those in diagnostic
nuclear medicine in that they are usually beta or alpha emitters with longer
physical and biological half-lives.

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 1.8. The Radiopharmacy is an integral part of a nuclear medicine and its prime
responsibility is the preparation of high quality radiopharmaceuticals, which is the
basis for a high quality nuclear medicine procedure (diagnostic or therapeutic).
1.9. For logistics and organizational purpose, nuclear medicine facilities can be:
1.9.1. General nuclear medicine facility
1.9.2. Advanced nuclear medicine facility including PET/CT and PET/MRI
NB: One facility can contain both general and advanced nuclear medicine facility or the
facilities can be separated

2. Practice

2.1. The Nuclear Medicine facility shall have written procedure for the diagnosis of
different health problems using radiopharmaceuticals or radionuclides for both in
vivo imaging and non-imaging diagnostic techniques.
2.2. Healthcare Institutions providing Nuclear Medicine Services are recommended to
draw up policies and procedures (e.g. SOPs and Work Instructions) that contain the
following:
2.2.1. Policies and procedures related to quality, patient education, infection
control, and safety shall be developed and implemented;
2.2.2. Mission statement, objectives and scope of the NM Services;
2.2.3. Staff development and education programme;
2.2.4. Staff training and validation for use of equipment;
2.2.5. Radiation safety (for all staff, including non-medical staff who have access to
areas within the Healthcare Institution that are used for NM Services - e.g.
cleaners, porters) and radiopharmaceutical transport and waste management;
2.2.6. Facilities and equipment maintenance and operation;
2.2.7. Internal audit;
2.2.8. Quality control (“QC”) for equipment, radiopharmaceuticals and
environment/ facility
2.2.9. Preparation and management of radiopharmaceuticals;

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 2.2.10. Emergency and contingency plans (including the activation timelines of such
plans);
2.2.11. Serious reportable events and radiation accidents reporting; and
2.2.12. Patient instructions, including radiation safety precautions, to be taken after
administration of radiopharmaceuticals.
2.3. Any loaner unit that is in use for more than one month will be required to submit
evidence of testing by a qualified medical physicist within 90 days of installation. If
the loaner is in place for longer than six months, the facility must submit the unit
for accreditation evaluation, including clinical and phantom image assessment and
the corresponding fee.
2.4. Acceptance testing and commissioning shall be performed based on written
policies and procedures. The procedures shall address the followings;
2.4.1. Major nuclear medicine instruments like Rectilinear Scanner, Whole Body
Scanner, Planar Gamma Camera, SPECT, PET, SPECT/CT, PET/CT etc. shall be
tested during installation.
2.4.2. A qualified practicing medical physicist, nuclear medicine technologist or
medical physicist shall perform these tests using internationally accepted
protocols.
2.4.3. The test results shall be reviewed by the qualified medical physicist and
documented in the annual survey report. Based on this report the supervising
physician is responsible for assuring compliance with the recommendations of
the medical physicist.
2.4.4. External auditing shall be done at least annually. The performance tests
listed below shall be performed on all units as per the ENRPA or NEMA and/or
the IAEA QC protocols:
 Intrinsic Uniformity
 System Uniformity
 Intrinsic or System Spatial Resolution
 Image Resolution Test
 Linearity Test

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 Sensitivity
 Center of Rotation Test and Calibration
 Energy Resolution
 Count Rate Parameters
 Formatter/Video Display
 Overall System Performance for SPECT Systems
 System Interlocks
 Dose Calibrators (Radionuclide Calibrator) - Performed as per
the protocol of NEMA or/and the IAEA to verify that readings
from this instrument are accurate (accuracy test). All basic
measurements of performance must be done at the time of
installation and repeated after major repair. This test must be
done according to protocols accepted by the appropriate
National Regulatory Authority (Ethiopian Radiation Protection
Authority (ERPA)).
o “Test” measurement of battery voltage (if applicable)
o Zero adjustment (if applicable)
o Background adjustment
o Accuracy and precision tests with NIST traceable
standard
o Linearity
o Geometry
o Constancy test
o Operational Checks (Check of Reproducibility and
Background Response)
 Thyroid Uptake Probe and Other Counting Systems for gamma
radiation measurements for in vitro (e.g. Gamma
spectrometers/well-type scintillation counters) - performed to
verify, integral background count rate, function of scalar
timer/rate meter, energy calibration, energy linearity, energy

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 resolution, sensitivity, and reliability (Chi-squared test) for the
measurement of organ function, the assay of patient samples
and for counting of other related radioactivity sources using
short and long lived radionuclides like:
o I-123 or I-131 capsule
o Tc-99m and
o long-lived standard calibration sources(e.g. Cs-137, Co-
57)
2.4.5. The nuclear medicine technologist shall be responsible for verifying day to
day operation of instruments and performing a few additional tests on a
quarterly basis.
2.4.6. The following quality control tests shall be made by the nuclear medicine
technologist:
2.4.6.1. Intrinsic or System Uniformity (each day of use)
2.4.6.2. Intrinsic or System Spatial Resolution (weekly)
2.4.6.3. Center-of-Rotation or Multiple Detector Registration Calibration/Test
for SPECT Systems (monthly).
2.4.6.4. High-Count Floods for Uniformity Correction for SPECT Systems
(frequency as recommended by a qualified medical physicist).
2.4.6.5. Overall System Performance for SPECT Systems (quarterly).
2.4.6.6. Thyroid Uptake and Counting Systems (each day of use) - Standards
are measured to verify energy calibration and sensitivity for the
measurement of organ function and the assay of patient samples.
2.4.7. Documentation of compliance with all quality control tests and corrective
action shall be required as part of the application process.
2.4.8. Policies and procedures related to quality, patient education, infection
control, and safety shall be developed and implemented in accordance with the
IAEA Policy on Quality Control and Improvement, Safety, Infection Control and
Patient Education Concerns.

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2.5. The site shall have a quality assurance program that incorporates the following two
elements:
2.5.1. Physician Peer Review: Examinations should be systematically reviewed and
evaluated as part of the overall quality improvement program at the facility
using written procedures.
2.5.2. Appropriateness/ outcomes analysis: The results of an appropriateness/
outcomes analysis and the actions taken to correct any deficiencies should be
maintained as quality assurance records at the facility. Policy and procedures
should be in place to look at the diagnostic accuracy and outcome of nuclear
medicine examinations. Documentation may be requested as part of an on-site
survey.
2.6. Data shall be collected and processed according to the instructions provided in the
testing package. The procedures may differ from those normally used by the
applicant but were designed to minimize the variability in the images submitted by
different facilities.
2.7. All films (or hard copies) or/and burned CDs are an important part of the medical
record. The following shall be permanently recorded on each image of the study:
patient name, patient age (or date of birth), patient identification number, date of
exam, and institution name. The technologist’s name, initials, or other means of
identifying the technologist who performed the study shall also be indicated.
2.8. A corresponding, dated physician report that clearly states the type of examination
performed and the clinical history shall accompany all examinations. The
parameters that will be scored on the clinical images include: radiopharmaceutical
bio-distribution, image acquisition, processing, and display, as well as film and
report identification. Patient films or/and the corresponding hard copy or burned
CDs shall be returned as required with the final report.
2.9. The Nuclear Medicine shall notify the regulatory body if they have permanently
withdrawn (i.e., removed) a unit from service, if they have replaced that unit with a
new one or have added another unit.
2.10. Minimum Quality Control (“QC”) tests and Parameters that must be
performed according to Instrument/Equipment Type in Nuclear Medicine & PET

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2.10.1. Healthcare Institutions providing NM Services shall perform and comply
with the minimum QC tests and parameters set out in Table 1 below and in
accordance with the methods and acceptance criteria specified in the
equipment manufacturers’ operation manuals and IAEA standards. Healthcare
Institutions providing NM Services shall also ensure that their QC policies and
procedures include these minimum QC tests and parameters. They shall
properly document their compliance with these minimum QC tests and
parameters, and retain those records for an appropriate period of time for
audit purposes, in accordance with its policies.
2.10.2. The following equipment shall be needed for the QC of Scintillation
2.10.2.1. Gamma Camera:
2.10.2.1.1. Sufficient Supply of Tc-99m Generators
2.10.2.1.2. Co-57 Flood Source
2.10.2.1.3. Four Quadrant Bar Phantom
2.10.2.1.4. SPECT Phantom
2.10.2.1.5. Disposable; Petri dish, Capillary tubes
2.10.2.2. The following Equipments are also recommended in order to follow
good work practices:
2.10.2.2.1. Refillable flood source
2.10.2.2.2. Copper plates for evaluation of count rate response
2.10.2.2.3. Computer generated test image

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Table 1: Minimum QC tests and parameters

S/N Type of Frequency of QC Parameters to Standard or Reference Acceptance Criteria

Instrument Check be checked Materials/ Equipment &
Or Methods
Equipment
1 Gamma Daily Photopeak & Energy Cobalt flood source or
57
Photopeak centered for
Camera Window Setting Technetium unsealed check
99m
radionuclide with a 20%
source or other suitable sources energy window.
Daily Uniformity 57
Cobalt flood source or Central & useful Field of View
(Extrinsic or 99m
Technetium point source or (“FOV”) integral & differential
Intrinsic) other suitable sources uniformity are < 10%.
Daily (For CT Tube Warm Up & N.A. Pass according to
SPECT/CT) Air Calibration manufacturer’s
recommendation.
Quarterly or CT Number CT Phantom CT Number <5 Hounsfield
during units or according to
preventive manufacturer’s
maintenance recommendation (whichever
(For is more stringent).
SPECT/CT)
Bi-Weekly Centre of Rotation 99m
Technetium check source COR error <0.5pixels or < 2mm
(COR) Only for or according to manufacturer’s
SPECT Gamma recommendation (whichever
Cameras is more stringent).
Half-yearly 1 To determine Full Wave Half Spatial Resolution values meet
Maximum (“FWHM”) = 1.75 x equipment specification.
smallest resolvable spacing using
the 4-quardrant bar phantom or
by any other suitable method.
Quarterly or CT Uniformity, CT CT phantom Pass CT Uniformity and
during Contrast & CT Contrast and no artifact/s
preventive Artefact seen.

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 maintenance
(For
SPECT/CT)
Quarterly or Energy & Uniformity Cobalt flood source or
57
Performed.
during correction Technetium point source
99m

preventive tables/files/ maps

maintenance
At acceptance Sensitivity 99m
Technetium source Sensitivity meets equipment
testing specification.
At acceptance Count Rate Varying 99mTechnetium activities. Count Rate Characteristics
testing Characteristics Measure & plot observed count meet equipment specification.
rate versus activity.
2 Dose Daily Constancy with Calibrated & traceable sealed Percentage difference between
calibrator Long Half-Life reference sources of 137Cesium measured & theoretical
Radionuclides &57Cobalt activities <5% for 137Cesium
&57Cobalt.
Semi annually Linearity ResponseMethod 1: Measure the decaying Measured radionuclide half-
to 99mTechnetium or
99m
Technetium or 18Fluorine for a life is < +/-10% of theoretical
18
Fluorine minimum of two half-lives. Plot value.
activity time graph to determine
half-life of radionuclide.
OR
Method 2: Varying attenuation
sleeves for a fixed activity of
99m
Technetium or 18Fluorine.
3 PET/CT Daily CT Tube Warm Up & N.A. Pass according to
Air Calibration manufacturer’s
recommendation.
Quarterly or CT Number CT Phantom CT Number <+/-5Hounsfield
during units or according to
preventive manufacturer’s
maintenance recommendation (whichever

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 is more stringent).
Quarterly or Radioactivity SUV phantom or water filled Pass according to
during - counts phantom with 18Fluorine or manufacturer’s
preventive calibration 68
Galium. recommendation.
maintenance
Daily PET detector Germanium or 22Sodium
68
Pass according to
stability / constancy manufacturer’s
recommendation.
Daily (for TOF PET Daily Germanium or 22Sodium
68
Pass according to
PET) Coincidence Timing manufacturer’s
Resolution recommendation.
Quarterly or CT Uniformity, CT CT phantom Pass CT Uniformity and
during Contrast & CT Contrast and no artifact/s
preventive Artefact seen.
maintenance
(For
SPECT/CT)
At acceptance Accuracy of PET/CT 18
Fluorine filled image quality Within ±1 pixel when using a
testing Image Registration phantom and heavy weights to 512 x 512 matrix or according
simulate a patient to manufacturer’s
recommendation (whichever
is more stringent).
At acceptance Sensitivity Test 18
Fluorine Line source and Pass according to
testing aluminium sleeves manufacturer’s
recommendation.
At acceptance Spatial Resolution Fluorine Point sources
18
Pass according to
testing Test manufacturer’s
recommendation.

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3. Radiopharmacy/Nuclear Pharmacy

3.1. The Radiopharmacy shall have written procedure for the preparation of all
radiopharmaceuticals used for diagnosis and therapy
3.2. The Radiopharmacy shall have written procedure for the quality control of
radiopharmaceuticals and Radiopharmacy equipment
3.3. The compounding and dispensing area for radioactive medicines shall be separate
from that of non-radioactive medicines, and shall be secured from unauthorized
personnel.
3.4. A specification should be available for each starting material/radiolabelling kit
used as well as for radiopharmaceutical products.
3.5. Preparation of radiopharmaceuticals shall be as per the requirements set by
Ethiopian Food and Drug Administration(EFDA)
3.6. Radiation Safety procedures during practices and disposal of radioactive wastage
shall be as per the requirements set by the Ethiopian Radiation Protection
Authority and this standard
3.7. The following quality control tests shall be made by the Radiopharmacist:

o Dose Calibrators (daily, quarterly, and semiannual)

 Daily - Tests are performed to verify that the calibrator

isaccurate and reliable for the assay of doses administered
topatients.

 Quarterly - A linearity test must be performed to document

thataccurate readings are provided through the entire range
ofactivities used clinically. Other qualified personnel may do
thesetests.

 Semiannual - All non-exempt radionuclide sources must

betested to verify that radioactivity is not leaking from the
sources.

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  Other qualified personnel may also do these tests.

3.8. The following radioactive sources shall be needed for the QC and calibration of
Dose calibrator

o Cs-137 dose calibrator source

o Co-57 dose calibrator source
o Sufficient Supply of Mo-99/Tc-99m Generators

3.9. In addition to any labeling requirements for non-radioactive medicines, the

immediate outer container of a radioactive medicine to be transported, stored
and/or dispensed shall also be labeled with:

a) The standard radiation symbol;

b) The words "Caution - Radioactive Material";
c) The radionuclide;
d) The chemical form;
e) The amount of radioactive material contained, in millicuries or
microcuries;
f) If a liquid, the volume;
g) The calibration time for the amount of radioactivity contained;
h) The expiration time; and
i) The name, address, and telephone number of the nuclear pharmacy
practice site.
j) Labeling efficiency

3.10. The immediate container shall be labeled with:

a) The standard radiation symbol;

b) The words "caution - radioactive material";
c) The name of the medicine; and
d) The medical or prescription order number.

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 3.11. The amount of radioactivity shall be determined by radiometric methods for
each product immediately prior to dispensing.
3.12. A nuclear pharmacy practice site shall conduct and keep proper records of
appropriate internal test assessments on all radiopharmaceuticals, with
interpretation of the resulting data to determine suitability for use in humans.
3.13. A nuclear pharmacy practice site shall conduct authentication of product
history by identifying and keeping proper records of the purchasing source, the
ultimate fate, and any intermediate handling of any component of a
radiopharmaceuticals.
3.14. Products shall be protected from unintended discharges arising during its
preparation and the environment shall be protected from unintended discharge of
radioactive materials from the radiopharmacy
3.15. The Radiopharmacy shall have written procedure for the management and
disposal of radiopharmaceutical and other nuclear medicine wastes.
4. Premises (Facilities)

4.1. Healthcare Institutions providing NM Services are recommended to have patient

and staff areas that:
4.1.1. Have appropriate markings and access controls for areas designated as
“restricted” and/or “controlled” in accordance with the requirements under the
ERPA and its regulations;
4.1.2. Provide adequate secure physical storage areas for patient records;
4.1.3. Provide adequate facilities for patient safety and privacy (e.g. changing
rooms);
4.1.4. Provide adequate waiting areas to segregate patients before and after the
administration of radiopharmaceuticals;
4.1.5. Provide appropriate lead-lining or other shielding of doors, walls, ceilings,
and floors of imaging rooms in accordance with the requirements stipulated
under the ERPA and its regulations;
4.1.6. Provide adequate Hot Toilets for the exclusive use of patients after the
administration of radiopharmaceuticals;

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 4.1.7. Provide adequate areas for the procurement, receipt, use, preparation,
administration, storage and disposal of radiopharmaceuticals. The areas that
are used for the storage and disposal of radiopharmaceuticals, including any
radioactive waste, must be controlled and secured, and
4.1.8. Provide adequate decontamination facilities
4.2. In addition to the requirements in paragraphs 4.1..1, 4.1.3 and 4.1.4, Healthcare
Institutions providing NM Services involving inpatient therapy are recommended
to have patient and staff areas that:
4.2.1. Provide appropriate designated ward(s) with appropriate markings, surface,
shielding, sanitation and ventilation in accordance with the requirements
under the ERPA and its regulations;
4.2.2. Provide adequate radiation protection measures for family/caregivers, staff
and the public; and
4.2.3. Provide adequate sewerage management system for the storage for decay
and the controlled discharge of radioactive patient waste.
4.3. Minimum Facility and Personal Protective Equipment (“Ppe”) Requirements
for Radiopharmacies
4.3.1. Radiopharmacies are recommended to meet the minimum requirements set
out below. The requirements contained divided into three sections:
4.3.1.1. A series of general requirements in relation to the design, structure
and layout of the radiopharmacy which shall be complied with by all
Healthcare Institutions which provide NM Services;
4.3.1.2. A series of general aseptic practice requirements which shall also be
complied with by all Healthcare Institutions which provide NM Services;
and
4.3.1.3. A series of specific requirements that shall apply depending on the
categorization of the Radiopharmacy as determined in accordance with
Table 2 below.
4.3.2. Healthcare Institutions intending to provide NM Services are recommended
to determine the relevant category of their Radiopharmacy in accordance with

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 Table 2. These classifications are based on the guidelines issued by the IAEA for
good radiopharmaceutical practices

4.4. General Requirements

4.4.1. All Healthcare Institutions providing NM Services are recommended to
ensure that their Hot Labs comply with the following general requirements:
4.4.1.1. The Radiopharmacy room must be in a separate, dedicated and
secured area that is close to the imaging and patient injection areas;
4.4.1.2. The Radiopharmacy Laboratory must be specifically designed and
maintained to handle unsealed radionuclides in compliance with the
requirements stipulated under the ERPA and the IAEA Basic Safety
Standards (“BSS”);
4.4.1.3. All work surfaces in the Radiopharmacy shall be smooth and
impermeable to permit easy cleaning and decontamination;
4.4.1.4. All plumbing pipe work and cables located in the Radiopharmacy shall
be encased and adequately laid to facilitate cleaning and decontamination;
4.4.1.5. There shall be adequate space in the Radiopharmacy to accommodate
all essential equipment and accessories (e.g. shielded Biosafety cabinet,
laminar flow hood(s), lead shields for handling radiopharmaceuticals, and
pharmaceutical isolator or other environmental cabinet(s));
4.4.1.6. There shall be adequate space for at least two staff members to
operate simultaneously;
4.4.1.7. The work areas in the Radiopharmacy shall have adequate lighting,
temperature and humidity so as to ensure operator comfort, optimum
equipment performance and expected radiopharmaceutical stability;
4.4.1.8. There shall be adequate waste storage containers in the
Radiopharmacy for sharps and general waste;
4.4.1.9. Radioactive waste of different half-lives shall be appropriately
segregated to ensure safe disposal, to comply with ERPA;
4.4.1.10. All radioactive waste shall be adequately shielded.
4.5. General Aseptic Practices

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 4.5.1. All Healthcare Institutions providing NM Services are recommended to
ensure that they implement the following general aseptic practices in their
Radiopharmacies:
4.5.1.1. Food and drinks must not be brought into or stored in the
Radiopharmacy room;
4.5.1.2. Access to the Radiopharmacy Room should be restricted to qualified
personnel with specific responsibilities or assigned tasks;
4.5.1.3. There should be adequate disinfection of work surfaces with 70%
sterile alcohol before and after work. Regular disinfection of work surface
and gloved hands during preparation should also be done;
4.5.1.4. Personnel should avoid touching critical surfaces (e.g. rubber closures
of containers, sterile needle tips, or any surface that comes in contact with
the radiopharmaceuticals);
4.5.1.5. A direct open path should be maintained between the cabinet filter
and the area where aseptic manipulations are performed;
4.5.1.6. The air supply in PEC (e.g. Biosafety Cabinet, Laminar Flow Cupboard,
and Fume Cupboard) should be on at all times and airflow is to be kept
unobstructed. Upon turning on the PEC, it should be left running for a
minimum of 15 minutes and disinfected before use;
4.5.1.7. Only objects required for the preparation should be placed in the PEC.
Avoid excessive movement in the PEC other than the lead shielding
containers and blocks so as to minimize turbulence and introduction of
contaminated air.
4.6. Specific Requirements
4.6.1. The relevant requirements vary according to the Licensee’s intended use of
radiopharmaceuticals (e.g. diagnostic versus therapeutic) and the type of
radiopharmacy tasks being performed in the Radiopharmacy (e.g. dispensing
versus compounding of radiopharmaceuticals). Additional regulatory
requirements apply to Healthcare Institutions that provide NM services
involving inpatient therapy (see section 4.2.).

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4.6.2. Healthcare Institutions intending to provide NM Services are recommended
to determine the relevant category of their Radiopharmacy, and the respective
minimum facility and PPE requirements they are to abide by in accordance
with Table 2 below:

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Table 2 – Specific facility and personal protection equipment (PPE) requirements for Radiopharmacies andNuclear Medicine service according
to the category of Radiopharmacy tasks

Category Description of Radiopharmacy Minimum facility requirements Minimum PPE

1a Radiopharmacy involved in the dispensing of
radiopharmaceuticals purchased or supplied in
their final form from recognized and/or
authorized manufacturers or centralized
radiopharmacies, including:
1) unit (department/ center) doses or
multiple doses of prepared
radiopharmaceuticals for which no
compounding is required; and
2) ready to use injections of strontium,
Rhenium, Yttrium, Samarium or others
for pain palliation or other uses.
1b Radiopharmacy involved inCategory 1a
activities and the dispensing of radioiodine
and other ready to use radiopharmaceuticals
that can produce radioactive vapors.
requirements
1. A radionuclide dose calibrator with 1. Personal radiation
appropriate lead shielding; and dosimeter;
2. A shielded dispensing station. 2. Disposable gloves; and
3. Overalls or jacket.
1. The minimum facility requirements
for a Category 1a facility;
2. A shielded fume cupboard with
suitable filters that can handle
radioactive vapors (e.g. from liquid
I solutions); and
131

3. A radiation exhaust monitor.

2a Radiopharmacy involved in Category 1b

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 activities and in the preparation of 1. The minimum facility
radiopharmaceuticals from prepared and requirements for a Category
approved reagent kits, generators and 1bfacility; and

radionuclides (closed procedure). 2. A shielded Class II vertical laminar

air flow (LAF) or a shielded
Biosafety cabinet/isolator.
3. Radiochromatography(TLC)
Scanner for quality control

2b Radiopharmacy involved in Category 2a

activities and in the manipulation and 1. The minimum facility
radiolabelling of autologous blood cells and requirements for a Category 2a
components for re-injection into the patient. facility; and
This includes radiolabelling of red blood cells, 2. A centrifuge for spinning down of
platelets and white cells commonly used for blood products.

infection or inflammation imaging.

3a Radiopharmacy involved in Category 2b 1. The minimum facility requirements
activities and in the compounding of for a Category 2b facility.
radiopharmaceuticals from ingredients and 2. Freeze dryer
radionuclides for diagnostic applications,
including: -
1) open procedures15;
2) modification to existing commercial kits;
3) in-house production of reagent kits from

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 ingredients, including freeze dried
operation; and
4) related research and development (e.g. Ga
68 PET radiopharmaceutical
compounding)
3b Radiopharmacy involved in Category 3b
activities and in the compounding of
radiopharmaceuticals from ingredients and
radionuclides for therapeutic and diagnostic
applications, including: -
1) open procedures; and
2) Related research and development (e.g.
radio-iodination of meta-iodobenzyl
guanidine (MIBG-iobenguane) and
rhenium labelled lipiodol).
3c Radiopharmacy involved in the synthesis of PET
radiopharmaceuticals. This includes the
fludeoxyglucose (18F-FDG) used in PET-CT.
1. The minimum facility requirements
for a Category 3a facility; and
2. A separate fume hood externally
ducted for radio-iodination with
appropriate safety systems sited in a
separate environment with
appropriate shielding (for gamma as
well as beta radiation).
1. Must comply with the relevant
legislative and regulatory
requirements, and GMP standard
from Ethiopian Food and Drug
Administration(EFDA) and
Ethiopian Radiation Protection
Authority(ERPA)
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 4.7. Adequate facilities shall be provided for the overall service delivery:

Table 3: Room requirements in the nuclear medicine facility

Rooms Requirements (m2 )

Administration room (Staffs room) 12
Waiting room for patient’s family 12
Waiting room (preparation room) 12
Isolation room 12
Radiopharmaceuticals preparation room (Hot 24
Lab)
Radiopharmaceuticals Quality Control Room 12
Cell labeling room 24
Radiopharmaceuticals Treatment room 20
Decontamination room 6
Radiopharmaceutical injection room 4
Post injection room 12
Stress test room 12
Gamma probe room (uptake thyroid) 9
Gamma camera room According to the needs
RIA room 24
Consultation room 12
Expertise room 12
Medical record room 12
Staff room 12
Warehouse 6
Warehouse of radioactive waste 6
SPECT room 30
Main corridor According to the needs
Toilet for patient isolation room 6
Toilet for patient post injection 6
Toilet for staffs 6
Emergency shower and toilet 6

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5. Professional

5.1. The clinical nuclear medicine service shall be directed by a licensed specialized
medical doctor who has been trained in nuclear medicine.
5.2. The Radiopharmacy service shall be directed by a licensed pharmacist who has
been trained in nuclear pharmacy.
5.3. The nuclear medicine service shall have at least the following licensed
professionals
5.3.1. Nuclear Medicine Specialists: Degree in Medicine and a specialty certificate in
nuclear medicine or equivalence of specialty certificate in nuclear medicine.
5.3.2. Nuclear Medicine technologist: A radiographer with B.Sc. degree in
Radiography and who has been trained in nuclear medicine technology
5.3.3. Nuclear medicine technician: A radiographer with Diploma in Radiography
and who has been trained in nuclear medicine technology
5.3.4. Radiographer: Bachelor of Science (BSc) in Radiography Technology and
licensed
5.3.5. Medical physicist: Postgraduate to MSc in medical physics with a major in
nuclear medicine
5.3.6. Radiopharmacist(Nuclear Pharmacist): Postgraduate to MSc in
Radiopharmacy (Nuclear Pharmacy) and licensed or Pharmacist after
completion of a basic training programme in radiopharmacy
5.3.7. Radiopharmaceuticals Scientist and Radiopharmacist for large Nuclear
Medicine facilities including positron emission tomography (PET) centers:
Qualified and registered pharmacist, ideally with postgraduate qualification
and experience with radiopharmaceuticals, or radiopharmaceuticals scientist
with MSc recognized as authorized or qualified person
5.3.8. Nurse: Qualified and Licensed Nurse with Training in Nuclear Medicine
5.3.9. Nuclear medicine engineer/Biomedical engineer (may not be necessary as
full time job).
5.3.10. Radiation protection committee presided by Radiation Protection Officer or
Radiation Safety Officer.

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6. Products(Equipment )

6.1. Healthcare Institutions providing NM Services are recommended to:

6.1.1. Provide adequate emergency and resuscitation equipment;
6.1.2. Provide adequate radiation monitoring devices, including dose calibrator/s
and radiation survey meter/s;
6.1.3. Provide adequate radionuclide dose calibrators with appropriate lead
shielding and calibration of long half-life radionuclide Quality Control (“QC”)
sources;
6.1.4. Provide adequate primary and secondary containers for transportation
(within and outside the premises) of radioactive materials; and
6.1.5. Provide adequate decontamination kit and personal protective equipment
(“PPE”) to manage radioactive spills.
6.1.6. The following shall be the list of Equipment and Instrumentation used in
theImaging and clinical nuclear medicine section:
6.1.6.1. SPECT, SPECT-CT, PET or PET-CT Cameras
6.1.6.2. Dose calibrator or decay correction calculation system
6.1.6.3. Imaging/counting equipment
6.1.6.4. Radiation monitoring devices including
6.1.6.4.1. portable survey meter (required)
6.1.6.4.2. removable contamination counting equipment (as applicable)
6.1.6.4.3. fixed area survey meter for dose preparation/storage areas
(asapplicable)
6.1.6.5. Resuscitation equipment and supplies (appropriate to the types
ofprocedures being performed)
6.1.6.5.1. Oxygen
6.1.6.5.2. defibrillator/AED (checks scored in B3.3.1)
6.1.6.5.3. emergency medicines (including a master list; all unexpired)
6.1.6.6. Exercise equipment (as applicable)
6.1.6.7. ECG equipment (as applicable)
6.1.6.8. Ancillary monitoring equipment (as applicable)

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 6.1.6.9. Infusion pumps/automated injectors (as applicable)
6.1.6.10. Glucometers (as applicable)
6.1.6.11. Hood for volatile radionuclides or cell handling (as applicable)
6.1.6.12. Xenon (or other gas) trap (as applicable)
6.1.6.13. Lead apron, decontamination solution, goggle and thyroid shield
6.1.7. Each nuclear pharmacy practice site shall contain at least the following list of
products (equipment):
6.1.7.1. Radionuclide Generator, Radiopharmaceuticals, Radionuclide and
non-radioactive supplies as per the national Medicines list
6.1.7.2. Organic Solvents
6.1.7.3. Vertical laminar flow hood with Area Monitor
6.1.7.4. Dose Calibrator with Molly Assay Canisten
6.1.7.5. Gamma spectrometer
6.1.7.6. Analytical balances and PH Meters
6.1.7.7. Lead pot, lead syringe carrier and lead bencher with glasses
6.1.7.8. Lead Brick, Castle Set
6.1.7.9. Radioactive storage Cabinet and radioactive waste storage Cabinet
6.1.7.10. Waste bin
6.1.7.11. Refrigerator, dry and wet autoclaves
6.1.7.12. Radiation exposure monitor; Hand and Foot Monitor
6.1.7.13. Portable survey meter;
6.1.7.14. Single or multiple channel scintillation counter;
6.1.7.15. Microscope, test tubes, different supplies;
6.1.7.16. Radio chemical exhaust hood and filter system (Fume Hood - 6 mm Pb
Shield)
6.1.7.17. Lead apron, decontamination solution, goggle , thyroid shield and
Lead Gloves
6.1.7.18. TLC scanner(Radiochromatogram Scanner)
6.1.7.19. Area Monitor
6.1.7.20. Forceps, Succors
6.1.7.21. electronic dosimeter

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 6.1.7.22. TLD including Finger TLD
6.1.7.23. Radioaerosol Ventilation System
6.1.7.24. Hotpot (Radiopharmaceuticals preparation boiling system) and water
bath
6.1.7.25. Aluminum break through test kit
6.1.7.26. Chromatography paper
6.1.7.27. Mobile Lead Shielded Barrier
6.1.7.28. Centrifuge
6.1.7.29. Water distiller
6.1.7.30. Room particle monitor
7. Quality control
7.1. Quality Control for Equipment
7.1.1. Healthcare Institutions providing NM Services are recommended to ensure
that acceptance testing for equipment used for NM Services is performed at the
time of installation (as part of the commissioning procedure) and after major
maintenance or software upgrades.
7.1.2. Healthcare Institutions providing NM Services are recommended to properly
document their quality control (“QC”) policies and procedures for equipment in
their SOPs and shall prepare their equipment in accordance with the
equipment manufacturer’s recommendations and/or international guidelines6.
QC policies and procedures must include the acceptance criteria that are used
for QC tests and the actions to be taken in the event of an unacceptable result
arising from such QC tests. QC policies and procedures must include the
minimum QC tests and parameters set out in Table 1.
7.1.3. Healthcare Institutions providing NM Services are recommended to perform
QC tests regularly and in accordance with their QC policies and procedures.
7.2. Quality Control for Radiopharmaceuticals
7.2.1. Healthcare Institutions providing NM Services are recommended to ensure
that the procurement, receipt, use, preparation, administration, storage and
disposal of radiopharmaceuticals comply with existing requirements and
relevant guidelines issued by the relevant regulatory agencies.

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 7.2.2. Healthcare Institutions providing NM Services are recommended to develop
acceptance/rejection criteria for all radiopharmaceuticals (whether they were
procured commercially from appropriately authorized or licensed suppliers or
prepared in-house) and are recommended ensuring that these criteria are
adhered to.
7.2.3. Healthcare Institutions providing NM Services are recommended to keep
securely all QC documents for all commercially procured radiopharmaceuticals,
in accordance with the retention period in its policies.
7.2.4. Healthcare Institutions providing NM Services are recommended to perform
QC tests, record and keep all records of such QC tests for all
radiopharmaceuticals that are prepared in-house, in accordance with the
retention period in its policies.
7.2.5. Healthcare Institutions providing NM Services are recommended to properly
document all guidelines and formulas used for the in-house preparation of
radiopharmaceuticals in their SOPs, and are recommended to keep all raw data,
in accordance with the retention period in its policies.
7.3. Quality Control for Environment/Facility
7.3.1. Healthcare Institutions providing NM Services are recommended to check, at
the outset of their provision of NM Services, that the Primary Engineering
Control (“PEC”) (e.g. the Biosafety Cabinet, Laminar Flow Cupboard, Fume
Cupboard) at areas of the facility where radiopharmaceuticals are handled
satisfy the qualifications7, in order to establish a baseline level of
environmental quality. Thereafter, they are recommended to periodically check
that the qualifications of the PEC [i.e. Performance Qualification (“PQ”)]) are
satisfied on an ongoing basis, in accordance with its manufacturer’s
recommendations.
7.3.2. Healthcare Institutions providing NM Services are recommended to establish
a monitoring system for radiation levels in the areas of the facility where
radiopharmaceuticals are handled.

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 7.3.3. Healthcare Institutions providing NM Services are recommended to obtain
re-certification by the relevant authority if there are changes to the
radiopharmaceutical storage area.
7.3.4. Healthcare Institutions providing NM Services are recommended to take
prompt decontamination corrective actions in response to any radioactive
spills.
7.3.5. Healthcare Institutions providing NM Services are recommended to
undertake radiation monitoring following any decontamination to confirm that
the radiation levels in the facility are within safe levels.
8. Records (Documentation)
8.1. Healthcare Institutions providing NM Services are recommended to properly
document and retain the following records listed in paragraphs 8.1. 1 to 8.1.11
below for an appropriate period of time for audit purposes and in accordance with
its policies:

Staff

8.1.1. Job descriptions and qualification(s) of Staff involved in the provision of NM

Services;
8.1.2. Competency assessments and training records
8.1.3. Personal radiation dose records of staff;
8.1.4. Radioactive waste disposal records;

QC Records

8.1.5. Equipment –
8.1.5.1. Preventive maintenance of equipment;
8.1.5.2. Records on testing of the radionuclide dose calibrator for constancy,
accuracy, linearity, and geometric variation;
8.1.5.3. Records of all QC parameters;
8.1.6. Radiopharmaceuticals –
8.1.6.1. Records on the procurement, receipt, use, preparation,
administration, storage and disposal of all radiopharmaceuticals;

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 8.1.6.2. Records on the identity of the radiopharmaceutical, the amount of
radioactivity administered, the identity of the patient and of the individual
performing the administration; the route of administration; and the date
and time of administration;
8.1.6.3. Records on the verification of the identity of the radiopharmaceutical
and patient, and the route of administration prior to administration;
8.1.7. Environment/Facility –
8.1.7.1. Preventive maintenance of PEC;
8.1.7.2. Radiation monitoring records which shall include radiation room
surveys; and
8.1.7.3. Records on investigation and follow-up actions of radioactive spillage
and management;

Patient and Personnel Safety

8.1.8. Records on investigation of adverse reactions associated with the

administration of radiopharmaceuticals; and
8.1.9. Records on investigation and follow-up actions of incidents;

Medical Records

8.1.10. All medical records are recommended to be retained in accordance with the
current National Guidelines.
8.1.11. Healthcare Institutions providing NM Services are recommended to also
implement adequate safeguards (including administrative, technical and
physical measures) to ensure that all records containing patients’ information
remain confidential.

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9. RIA/IRMA
9.1. Nuclear medicine services may or may not provide RIA/IMRA services
9.2. In-vitro section of the nuclear medicine shall have a minimum of 24 meter square
space to conduct all RIA/IMRA procedures.
9.3. The hospital shall have written procedure for in vitro techniques such as radio-
immunoassay (RIA) and immuno-radiometric assay (IRMA).
9.4. Professional: RIA/IRMA Technologist: A biologist/ chemist /laboratory
technologist/ pharmacist who has been trained in RIA/IRMA techniques.
9.5. Products
9.5.1. The following shall be minimum equipment requirements for
RIA/IMRAwork:
9.5.1.1. Refrigerator
9.5.1.2. Deep freezer
9.5.1.3. Centrifuge to hold 60-100 tubes
9.5.1.4. Thermostatically controlled water bath
9.5.1.5. Ice bath
9.5.1.6. RIA Counter
9.5.1.7. Distilling or de-ionizing water
9.5.1.8. Voltage stabilizer,
9.5.1.9. Precision balance
9.5.1.10. Semi-analytical balance
9.5.1.11. Magnetic stirrer with Teflon coated stirring bars,
9.5.1.12. Vortex mixer,
9.5.1.13. Automatic pipette washer,
9.5.1.14. Scientific calculator
9.5.1.15. Ultrasonic cleaner
9.5.1.16. Foot-operated dustbin
9.5.1.17. Air conditioner
9.5.1.18. Centrifuge
9.5.1.19. Survey meter data ‘monitor’

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10.Radioactive iodine therapy for thyroid diseases

10.1. Radioactive iodine (sodium I-131) is a form of radiation treatment that has
been used for many years to treat thyroid conditions. These thyroid conditions are
thyrotoxicosis and well-differentiated thyroid cancer.
10.2. Any nuclear medicine facility providing radioactive iodine should have a
written guideline or SOP.
10.3. Multidisciplinary team including surgeon, pathologist, radiology, oncologist,
endocrinologists and nuclear medicine physician must be involved in the
management of these patients. The facility may not contain all the professionals but
should have a consultation and collaboration system with others and must stat the
name of and the level of agreement with other health facility should be mandatory
10.4. Major clinical criteria for radiation dose adjustment for each patient include
the stage of the thyroid cancer and the patient condition.
10.5. Implementation of a radiation protection and safety plan clearly indicating
radiation areas, the transport pathway for radioactive sources, workflow of I-131
treatment, storage of radioactive sources, local rules for workers in every level on
working with radioactive sources, control of worker dose (5mSv yr−1), outline
measurement of radiation at check points and working surface areas, radioactive
waste management, criteria for releasing a patient, criteria of waste clearing levels,
and records and reports of the radiation safety control system.
 Everyone involved with patient must wear film badge
 Gloves must be used by patient to handle telephone, bed controls, radio/TV control or
these devices must be covered with tape
 Housekeeping not allowed in room until room is released by RSO No visitors for at least
24 hr. (some practitioners permit 30 min visit)
 No bed baths
 Patient must stay in bed unless instructed otherwise
 Absorbent pads taped to floor from toilet to bed
 Room must be surveyed by RSO prior to release for next use
 Every participant in therapy should have thyroid counted 24 hr. post dose

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 10.6. Premises: The facility needs a therapy room, isolation room, a nursing
station and waste management system. The isolation room should have an
individual toilet and bathroom, air conditioner, TV, nurse call, and CCTV for nurse
observation and nursing management. Each room’s walls are covered with lead
sheet; lead thickness varying from 5 to 10mm depending on radiation safety
criteria for each wall.
10.7. Professionals: the following professionals are required for radioactive
therapy; Nuclear Medicine Physician, Radiopharmacist and Medical Physicist.

11.Workflow in Nuclear Medicine facility

12.References
12.1. International Atomic Energy Agency, Vienna, 2008, Operational Guidance on
Hospital Radiopharmacy: A Safe and Effective Approach.
12.2. Ethiopian standards Agency, Addis Ababa, 2012, for comprehensive
Specialized Hospital Requirements
12.3. Ministry of Health Singapore, May 2019, Standards For The Provision of
Nuclear Medicine, Imaging, Therapy and Assay Services,
12.4. International Atomic Energy Agency (IAEA) , Vienna, 2008, Quality
management audits in nuclear medicine practices, Comprehensive Audit

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12.5. Mayani AN, Basari. Evaluation on requirements of nuclear medicine facility
building. InAIP Conference Proceedings 2019 Dec 10 (Vol. 2180, No. 1, p. 020049).
AIP Publishing LLC.
12.6. European Commission, EC Guide to Good Manufacturing Practice, Annex I, EU
Pharmaceutical Clean Room Standards (Grade A, B, C and D), EC, Brussels (2003).
12.7. International Atomic Energy Agency (IAEA) Basic Safety Standards (BSS).
12.8. International Atomic Energy Agency Human Health Series No. 6, Vienna,
2009, Quality Assurance for SPECT Systems.
12.9. Vilasdechanon, N; Ua-apisitwong, S; Chatnampet, K; Ekmahachai, M;
Vilasdechanon, J (2014). Design of patient rooms and automatic radioiodine-131
waste water management system for a thyroid cancer treatment ward: ‘Suandok
model’. Journal of Radiological Protection, 34(3), 699–708. doi:10.1088/0952-
4746/34/3/699.

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