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Regulatory Requirements To Practice Ct - Scan

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Regulatory Requirements To Practice Ct - Scan

Contents
1. Purpose...........................................................................................................................3
2. Scope..............................................................................................................................3
3. Responsible person........................................................................................................3
4. Definitions and Abbreviations.......................................................................................3
4.1 Definitions.......................................................................................................3
4.2 Abbreviations.................................................................................................. 4
5. Work Instruction............................................................................................................4
6. Reference Document......................................................................................................7

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Regulatory Requirements To Practice Ct - Scan

1. Purpose
This procedure is intended to establish basic/mandatory requirements required for license
in Computer Tomography (CT) Scanning and to assist inspectors to decide uniformly
whether a radiological facility should be licensed, not begin or stop its services by the
power vested to the ETA by proclamation No. 571/2008. This regulatory requirement will
be available and distributed to users beforehand so as to guide and inform them about the
license process to get authorization to practice diagnostic radiological services.

2. Scope
This regulatory requirement applies to Computer Tomography (CT) scanning facilities
practicing diagnostic imaging application with x-ray machine for the purposes of
obtaining diagnostic information of patients as prescribed by appropriate medical
personnel.

3. Responsible person:
DG, DDG, R/N/T/NAC

4. Definitions and Abbreviations

4.1 Definitions
"Baseline value" means the reference value provided by the manufacturer or the value
measured at acceptance testing. In the absence of these values, the values derived at the
first compliance test.
"Computed tomography" means reconstructive tomography in which recording and
processing is effected by a computing system.
"Computed tomography number" (CT number) means the number used to represent
the mean X-ray attenuation associated with each elemental area of the computed
tomography image. The CT number is normally expressed in Hounsfield units.
"Loading" means the act of supplying electrical energy to the anode of an X-ray tube.
“Computed Tomography Kerma Index” means the Computed Tomography Kerma
Index, C100, for a single axial scan is the quotient of the integral of the air kerma along a
line parallel to the axis of rotation of a CT scanner over a length of 100 mm and the
product of the number of acquired tomographic sections N and the nominal section
thickness T. The integration range is positioned symmetrically about the volume scanned,
thus
1 +50
C 100= ∫ K ( z ) dz
NT −50
“air kerma length product” means the air kerma-length product, PKL, is the integral of
the air kerma over a line, L, parallel to the axis of rotation of a computed tomography
P KL=∫ K ( z ) dz
scanner, thus L
For the purpose of this document the definition given in ISO 9000:2015 is used

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Regulatory Requirements To Practice Ct - Scan

Directorate Directors means: Directors in ETA

4.2 Abbreviations
ETA: Ethiopian Technology Authority
DG: Director General
DDG: Deputy Director General
R/N/T/NAC: Radiation and Nuclear Technology Notification and Authorization
Chief Executive Officer

5. Work Instruction

I- Safety I. Auxiliary rooms General  License Certificate

Provisions, X- Ray Dressing and toilet rooms Requirements from appropriate
Premise and that keep the privacy and Examination can be health and trade
Safety Control safety of the patients interrupted by bureaus and
System adjacent to the exposure operator: The Certificate that
A. Lead apron, room shall be provided operator must be assures the
Lead aprons of 0.50 Safety of the X- ray able to interrupt the institution is the
mm of lead (or lead Premise (Radiological examination at any registrant of TIN
equivalent) are protection survey) time. number shall be
indispensable for the The X-ray department Couch positioning submitted to ETA.
examiner and the must be safe from accuracy: The couch Personnel
radiographer and radiological point of view positioning accuracy Requirements
other staff involved at every location must not deviate by A Radiation Safety
as necessary (maximum of 1 µSv/hr at more than ±2 Officer (RSO) has to
Lead apron(s) all locations occupied by a millimeters. be officially assigned
integrity (Physical member of public and 7.5 Loading indication: by the organization
conditions for holes, µSv/hr in the control Loading indication applying for
cracks, etc) shall be cubicle and any must be by amber Authorization.
checked properly. occupationally accessed light and an audible At least one formally
Lead glass goggle location by radiation Signal both at the trained Radiologist
Lead glass goggles workers). control console and and Senior
have to be provided Lead glass window shall in the CT room. Radiographer has to
for protection of the be provided to the control Image Quality be available. If there
eye of the cubicle, and its thickness The mean CT is a higher workload
patient(Protective should have a nominal Number in center 120 patients per week
glass should be value of 2mm lead or its ROI ≤± 4 (~ 40 mA-min/week)
0.8mm lead glass or equivalent. The lead glass Deviations from and more than two of
at least 90mm plate shall be fitted at proper linearity should be < these practices are
glass). location to provide a clear ± 5 HU performed then
B. Gonad shields view (to the radiographer) Maximum différence additional Senior
Gonad shields of of a patient undergoing outrer/ centre ROI Radiographer has to

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Regulatory Requirements To Practice Ct - Scan

different sizes and radiological examination. ≤± 2 be provided.

shielding capacity at The wall of the CT-Scan Slice thickness Justification
least for standing room (exposure room) ≤±0.3mm for all Since CT procedures
positions shall be should be thick enough to slices contribute up to 40%
made available to be attenuate leakage of Position movement of the collective dose
used by patients and radiation. The wall discrepancy ≤± from diagnostic
pregnant women. thickness is generally 0.5mm of selected. radiology, it should
However, it is suggested to be 17 cm of Reproducibility of be justifiable.
advisable the concrete (pure) or position≤±1mm CT scan is one of the
provision of gonad equivalent, as an Distance of practices/procedures
shields for lying alternative to the light/Slice centre with significant dose
positions (here, it is description on the layout ≤±min slice width) to patients. Therefore,
assumed that gonad of the X-ray premise. All (The difference in sufficient justification
shields available for doors adjacent to the the CT number shall be made to
standing positions exposure room shall be between a peripheral prescribe CT scan by
will also be used for properly shielded /lead- and a central region qualified physicians
lying). lined with lead of 2mm or of a homogeneous based on valid
Gonad shields its equivalent material. test object should be clinical indication.
integrity (Physical Lead overlap shall be < 8HU) Ultrasound and
conditions for holes, made to avoid radiation MRI offer
Image noise
cracks, etc) shall be leakage at edges, hinges alternatives to CT in
The SD of CT
checked properly. and connections. many areas of
numbers in the
C. Lead gloves X-ray Machine applications.
central 500 mm2
Glove integrity Performance ROI for a water or
(Physical conditions Equipment of diagnostic It is also highly
tissue equivalent
for holes, cracks, etc) radiology shall conform to recommended that
phantom should not
shall be checked applicable national or errors (such as
deviate more than
properly. international standards exposure to wrong
20% from the
D. Personal such as the International patient, wrong organ,
baseline.
Monitoring Service Electro technical etc) shall be
CT number values
for radiation Commission (IEC) or avoided/minimized
workers International Standards The deviation in the by defense-in-depth
Personal monitoring Organization (ISO). CT number values procedures to confirm
service for all Such equipment should for water or tissue the right patient and
radiation workers satisfy the technical equivalent material target organ; as a
(such as radiologists, requirements of and materials of result proper working
radiographers and verification of machine different densities procedures and local
Radiation parameters, and Quality should <± 20 HU or safety rules shall be
Technologist shall be Assurance tests at large. 5%. established and
provided. Under all circumstances, CT number implemented.
E. Film Viewing Box the equipment should be uniformity Computed

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Regulatory Requirements To Practice Ct - Scan

Film viewing screen accompanied with the The SD of the CT tomography dose
with uniform light necessary documents number over a 500 index (CTDI)
intensity and color including the service and mm2 region of The CTDI for a
should be available. operating manuals, results interest for water or single slice for each
F. Area of the of acceptance tests, and tissue equivalent available beam
exposure room calibration certificate for material at the center shaping filter and for
Area of the exposure the required machine and around the each available slice
room shall not be less parameters of the x-ray periphery of thickness should not
than 28 m2 for CT machine. phantoms < 1.5% of deviate more than ±
scan. 1. Deviation of kVp the baseline 20% from the
N.B. The exposure Accuracy ≤ ±10% baseline.
room shall have 2. Deviation of the X-ray Documentation
sufficient ventilation timer ≤ ±10% Requirements Irradiated slice
(such as a ventilation 3. Output inconsistency Full documentation thickness
window with a height ≤ 5% shall be presented The FWHM of the
above 2m from 4. The first half value with the application dose profile should
outside ground level layer in the X-ray for Authorization to not differ more than ±
and position in such a beam incident to the the Authority such 20% from baseline.
way that backscatter Patient must be as: High contrast
radiation will not fall greater than or equal Machine resolution (spatial
on windows of to: specifications (with resolution)
opposite building, a) 3.8 millimeters of manufacturer’s The FWHM of the
verandah, etc) aluminum at information, point spread function
G. Wall thickness maximum and of a pin, or the edge
120kVp; or
Wall thickness of at b) 4.2 millimeters of minimum response function of
least 17cm concrete aluminum at parameters that an edge should not
or its equivalent (with 130kVp. could be set, date of differ more than ±
no radiation leakage manufacture, etc) 20% from baseline.
to the surroundings, and shipping Low contrast
i.e. maximum of certificate as basic. resolution
1µSv/hr at all Floor layout of the Polystyrene pins of
locations occupied by facility, 0.35 cm diameter
a member of the Copies of inserted in a uniform
public and 7.5µSv/hr educational body water phantom
to the control cubicle qualifications of should be visible in
and any workers, the image.
occupationally
accessed location by Properly signed and
radiation workers) sealed completed
H. Warning light & notification &
signs application

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Regulatory Requirements To Practice Ct - Scan

Warning red light protocols AP-NT-

coupled/ 01 and AP-DR-01
synchronized with the
machine power shall
be provided at
appropriate
location(s).
Placards containing
international
radiation hazard sign
(Trefoil symbol) and
notices in English
and Amharic (or/and
other local languages)
should be available
and posted at suitable
locations. Local rules
should also be
presented describing
working procedures
and safety rules.

6. List of Forms
 Ionizing Radiation Notification APNT-01 form OF/ETA/099
 Application form to use diagnostic x- ray equipment and facility APDR-01
form OF/ETA/120

7. Reference Document
ETA Management Manual

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