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ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023 G.C
Title Issue No Page No.
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Regulatory Requirements For Nuclear Medicine
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Title Issue No Page No.
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Regulatory Requirements For Nuclear Medicine
Contents
1. Purpose......................................................................................................................................3
2. Scope.........................................................................................................................................3
3. Responsible person...................................................................................................................3
4. Definitions and Abbreviations..................................................................................................3
4.1 Definitions........................................................................................................................3
4.2 Abbreviations....................................................................................................................3
5. Practices....................................................................................................................................4
6. Premises....................................................................................................................................8
7. Professionals.............................................................................................................................8
8. Products..................................................................................................................................10
9. List of Forms...........................................................................................................................11
10. Reference Document...........................................................................................................11
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ETHIOPIAN TECHNOLOGY AUTHORITY 11/10/2023 G.C
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Regulatory Requirements For Nuclear Medicine
1. Purpose
These requirements intended to establish basic/mandatory requirements required for license in
Nuclear Medicine
2. Scope
This procedure applies to Nuclear Medicine facilities practicing for the purposes of obtaining
information of patients as prescribed by appropriate medical personnel.
3. Responsible person
Director /DG/ I/R/NAD
4. Definitions and Abbreviations
4.1 Definitions
For the purpose of this document the definition given in ISO 9000:2015 is used
Directorate Directors: Directors in ETA
Team Leader: Notification team leader and Authorization team leader
4.2 Abbreviations
ETA: Ethiopian T Authority
DG: Director General
I/R.NAD: Ionizing Radiation Notification and Authorization Directorate
5. Practices
1. Nuclear medicine center service shall have written policies and procedures that are reviewed
at least once every three year and implemented. These policies and procedures shall include
at least:
a) Safety practices;
b) Emergencies;
c) Adverse reactions;
d) Management of the critically ill patient;
e) Infection control, including patients in isolation;
f) Timelines of the availability of diagnostic imaging procedures and the results ff
g) Quality control program covering the inspection, maintenance, and calibration of all
equipment
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Regulatory Requirements For Nuclear Medicine
2. The nuclear medicine center at this level of practice shall have written procedures of various
tissue, organs and organ-systems.
3. The center shall have also written procedure for in vitro techniques such as radio-
immunoassay (RIA) and immune-radiometric assay (IRMA) if the in vitro nuclear medicine
activities at this level of practice are established as integral part of in vivo nuclear medicine
services in this center.
4. This center shall perform limited type of nuclear medicine therapeutic activities like
radioiodine treatment of thyrotoxicosis and P-32 treatment of polycythemia rubra vera
following the relevant standard written procedures. However, more advanced levels of
nuclear medicine therapeutic procedures like radioiodine treatment of thyroid cancers shall
not be carried out here.
5. The center shall have radio-pharmacy section that involves in formulation of various kits
manufactured by other centers /companies with radionuclide to produce radio-
pharmaceuticals. It shall not produce its own radiopharmaceutical kits.
6. The radio-pharmacy section of this center shall carry out some radiopharmaceutical quality
control activities like determination radiochemical and radionuclide purity,Mo-99
breakthrough tests etc.
7. This center shall procurer its own radionuclide generators like Mo-99/Tc-99m and carryout
the elution process of the generators.
8. Different types of static and dynamic nuclear medicine imaging procedures employing
various radiopharmaceuticals shall be carried out in this center.
9. All nuclear medicine services at this level-one center shall also be given at this level of
practice
10. The in vivo nuclear medicine services at this level of practice shall be established excluding
its in vitro activities and this shall also be applicable to its in vitro activities depending on the
desired intention of emphasis required to be given by the center. According it shall be
possible to establish the in vitro nuclear medicine services or the in vivo service
independently or integrated services (both in vitro and in vivo services) together.
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Regulatory Requirements For Nuclear Medicine
11. If the center established at this level of practice gives emphasis to its in vivo nuclear medicine
service then the in vitro service shall be optional and the vice versa shall also be true in case
of in vitro services.
12. Relevant timely acceptance tests shall be performed daily, weekly, monthly and annually as
the case demands on nuclear medicine imaging and related non-imaging instruments based on
the prevailing written policies/guidelines and procedures.
13. A qualified practicing nuclear medicine physicist, nuclear medicine technologist or medical
physicist shall perform these tests using internationally accepted protocols/procedures.
14. 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/nuclear medical
physicist.
15. Policies and procedures for nuclear medicine services at this level of practice shall be
available to all relevant professional staff working in the center.
16. There shall be a written protocol for managing medical emergencies in the nuclear medicine
suite. All nuclear medicine staff shall be instructed in this protocol and know their roles in the
case of such an emergency.
17. Nuclear medicine physician or Medical doctor trained properly in nuclear medicine shall
supervise and interpret all nuclear medicine procedures conducted at this level of practice
18. All nuclear medicine examinations shall be interpreted on a preliminary basis within eight
hours at all times. Emergency examination shall be given as early as possible.
19. The nuclear medicine activities of this center shall provide the following services at all times
20. a) Organ/tissue uptake (function) studies making use of radiopharmaceuticals
21. /radionuclide/.
22. b) Organ/systems imaging services making use of radiopharmaceuticals/radionuclide/
23. c) Serum determination of various hormones if the vitro activity is established as part of this
center
24. The nuclear medicine staff shall make every effort to ensure that patients waiting for nu
clear medicine service or transport from nuclear medicine are comfortable while waiting and
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Regulatory Requirements For Nuclear Medicine
that the service responsible for transporting the patient back to the unit is notified when the
patient is ready to be returned.
25. The nuclear medicine service unit shall be free of hazards to patients and personnel.
26. Proper safety precautions shall be maintained against fire and explosion hazards, electrical
hazards and radiation hazard s.
27. This center shall get approval from the appropriate National Radiation Regulatory Authority
(Ethiopian Radiation Protection Authority) through periodic inspection and hazard shall be
promptly corrected if identified.
28. Radiation workers shall be checked periodically from amount of radiation exposure by the
use of exposure meters or badge tests and this shall be documented.
29. Signed reports shall be filed with the patient’s medical report and duplicate copies kept in the
service unit.
30. Requests by the attending physician for nuclear medicine procedure (examination) shall
contain a concise statement of reason for the examination.
31. Reports of interpretation shall be written or dictated and signed by nuclear medicine
physicians or properly trained medical doctors in nuclear medicine.
32. Reporting form shall have minimum such as date, patient name age gender, findings and
name and signature of the nuclear medicine physician/medical doctor trained properly in
nuclear medicine.
33. All nuclear medicine examination result documents shall be preserved or microfilmed
according to the country’s law.
34. Nuclear medicine films shall be labeled with minimum information such as date, name, age
gender, right/left mark, views and names of radiographer.
35. Nuclear medicine services shall operate according to applicable country’s laws and IAEA
guiding principles.
36. A radiation safety program including timely reporting of radiation safety finding s shall be in
place, followed, and documented.
37. The professional/ practitioner who delivered the nuclear medicine service shall be responsible
for claims arising from wrong findings.
38. Nuclear medicine service shall be accessible to all requiring medical service units
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Regulatory Requirements For Nuclear Medicine
39. 4.4The nuclear medicine service has radiation hazards; hence the staff shall be supplemented
by monthly allowance (incentives shall be considered).
40. 4.5The nuclear medicine service staff shall be supplemented with dietary protection as
required by national radiation regulatory authority (Ethiopian radiation protection authority).
41. 4.6Radiopharmaceuticals of the desired quality (properly prepared and quality assured
radiopharmaceutical shall be administered to the patient by an appropriate nuclear medicine
professional.
42. 4.7No radiopharmaceutical formulation shall be carried out in this center and only readymade
radiopharmaceutical acquired from central radio pharmacy (ies) shall be used
43. 4.8If the vitro nuclear medicine (in vitro radio assays) service is part of this center, the
activity shall be conducted with ready to use RIA/IRMA kits and also radio iodination shall
be allowed to be carried out .besides radio labeling of various ligands with preparation of
kits and using them for in vitro radio assays shall be practiced in this center
6. Premises
1. Minimum number and size of rooms for this level of nuclear medicine practice are
given below:
a. 2 rooms for gamma camera or SPECT or SPECT/CT
b. 1 room for administrative activities
c. 1 room for patient records, and digital data storage
d. 1 room for collimated double scintillation probe(optional)
e. 1 room for administrative activities records and support areas
f. 1 computer room
g. 4 rooms for RIA/IRMA activities/procedures (optional)
h. 1 waiting room/area
i. 1 reception room / area
j. 1 radioactive materials used and storage room
k. 2 rooms for radiopharmaceutical activities
l. 2 examination rooms
m. 2 toilet rooms for patients and staff
n. 1 bath room
7. Professionals
1. The following minimum number of professionals shall be available at this level of practice:
1. 2 full time nuclear medicine physicians
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Regulatory Requirements For Nuclear Medicine
2. 1 radio pharmacist
3. 2 radio pharmacy technicians
4. 2 nuclear medicine technologist
5. 3 nuclear medicine technicians
6. 2 RIA/IRMA technologist and 3 technicians (optional
7. 1 medical physicist and 1 biomedical engineer on call when required
8. 1 registered nurse
9. 1trained dark room technician
10. 1 receptionist,
11. 1 cleaner
12. All nuclear medicine professionals (nuclear medicine physicians, nuclear
medicine technologist, RIA technologist, nuclear medicine technician etc)
performing nuclear medicine services in this level of practice shall be
registered by the authority.
13. A registered nuclear medicine physician shall be available in this center
during the nuclear medicine procedures being performed routinely apart
from the emergency case. A registered nuclear medicine technologist or
experienced technician shall be presented in this center at all times.
14. The nuclear medicine technologist/experienced nuclear medicine technician
shall be responsible for verifying day to day operation of instrument and
performing a few additional tests on quarterly basis.
15. The nuclear medicine technologist/experienced nuclear medicine technician
shall perform the following quality control test:
a. Intrinsic or system uniformity (each day of use).
b. Intrinsic or system special resolution (weekly).
c. Center- of –Rotation or multiple detector registration calibration /Test for SPECT
System (monthly).
d. High-count flood for uniformity correction to SPECT System (frequency are
recommended by a qualified medical physicist).
e. Overall system performance for SPECT System (quarterly).
f. Dose calibrators(daily, quarterly, and semiannual)
16. The nuclear medicine physicist shall conduct comprehensive periodic quality
assurance and control test on nuclear medicine instruments and at any time when
it is required on a part time or on call basis in this center.
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Regulatory Requirements For Nuclear Medicine
17. The nuclear medicine physicist shall perform rigorous acceptance tests on
nuclear medicine instrument based on written policies and procedures.
18. A registered professional nurse shall be available in the nuclear medicine service
to administer medication and perform other nursing duties.
19. Equipment maintenance engineer shall be available to ensure the proper
functioning of all nuclear medicine equipment. (as part time or can work at
specified time when the machine need service)
20. Trained dark room technician, a receptionist and cleaner shall be available in
nuclear medicine service as full time.
8. Products
1. Minimum medical equipment which shall be available for nuclear medicine
service at level of practice is indicated below:
a) Two gamma cameras or SPECT or SPECT/CT
b) One collimated double scintillation probe(optional)
c) Three dose calibrators
d) One rectilinear scanner (optional)
e) 2 well type scintillation counters(gamma spectrometry)
f) 2 viewing boxes
g) Standard sources:Co-57 and Cs-137
h) Resuscitation equipments
i) Emergency drugs/supplies
j) Telephone service
k) Procedure test
l) Computers
m) RIA/IRMA item (optional) as indicated below:
n) Refrigerator
o) Deep freezer
p) Centrifuge to hold 60-100 tubes
q) Thermostatically controlled water bath
r) Ice bath
s) RIA Counter
t) Distilling or de-ionizing water
u) Voltage stabilizer,
v) Precision balance
w) Semi-analytical balance
x) Magnetic stirrer with telephone coating stirring bars,
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Regulatory Requirements For Nuclear Medicine
y) Vortex mixer,
z) Automatic pipette washer,
aa) Scientific calculator
bb) Ultrasonic cleaner
cc) Foot-operated dustbin
dd) Air conditioner
ee) centrifuge
1. All diagnostic nuclear medicine equipment shall be regularly inspected,
maintained, and calibrated, and appropriate recurred are maintained.
2. All radiation generation equipment shall be installed with a building wall
thickness that fulfills the minimum criteria set by Ethiopian Radiation Protection
Authority/IAEA.
3. At least the following radiation protection equipment shall be available in nuclear
medicine service:
a) Lead gloves
b) Lead aprons
c) Gonad shields
d) Other shield e.g. for pregnant women if highly indicated
e) Radiation monitoring device including
Potable survey meter(required)
Removable contamination counting equipment(as applicable)
Fixed area survey meter for dose preparation /storage areas(as applicable)
4. The following equipment shall be needed for QC of Scintillation Gamma
Camera:
a) Sufficient supply of Mo-99/Tc-99 generators
b) Co-57 Flood source
c) Four Quadrant Bar Phantom
d) SPECT Phantom
e) Disposable; Petri dish, capillary tubes
The following equipment are also recommended in order to follow good
work places:
Refillable flood source
Copper plates for evaluation of count rate response
Computer generated test image
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Regulatory Requirements For Nuclear Medicine
5. Each nuclear radio pharmacy practice site of this center shall contain at least the
following list of products (equipment/item):
a) Radiopharmaceuticals and non-radioactive supplies as per the national drug list
b) Tc-99/Mo-99 generator
c) Various radiopharmaceutical kits
d) I-131Solution or Capsules
e) Fume hood
f) Analytical balances and PH Meters
g) Lead pot lead syringe carrier and lead bencher with glasses
h) Refrigerator
i) Radiation exposure monitor;
j) Portable survey meter;
k) Single or multiple channel scintillation counter;
l) Radio chemical exhaust hood and filter system
m) Portable survey meter ;
n) Mo-99 breakthrough test kits
o) Aluminum test kits
p) ITLC test kits
q) Eye goggles
r) Deep freeze
6. Safety procedures during practices and disposal of unit for use equipment shall
be installed as per the requirement set by the Ethiopian Radiation Protection Authority during
all procedures.
9. List of Forms
Ionizing Radiation Notification APNT-01 Form…………………. OF/ETA/099
Application Form for Authorization To Nuclear Medicine Equipment And Facility
Form………………………………………………………………….. OF/ETA/123
10. Reference Document
ETA Management Manual…………………………………………….MM/ETA/001
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