Mandatory Regulatory Requirement

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Mandatory Regulatory Requirement Powered By Docstoc
					                                                                                            The Ethiopian Radiation Protection Authority (ERPA)
     Mandatory Regulatory Requirements to Practice Conventional Diagnostic Radiology and for
                                    Issuance of a License
I - Introduction
Background
The number of radiation sources in Ethiopia is mainly in medical applications. Medical exposure control has been therefore
one of the important activities of the ERPA almost for more than a decade. Some good progresses in the quality of
radiological services and safety of medical institutions in the country have been recorded. This can be justified by the
increased number of licensed medical applications, as licenses are issued when set regulatory requirements are fulfilled and
it can be considered as a good indicator of the level of radiation protection and overall standard of a radiological facility.
Besides, Situational Analysis conducted by the ERPA for the last 7 years (four in number between 2000 and 2007) can
serve as an indicator on the level of progress in radiological diagnostic services in the country. However, due to its very
nature quality of service and safety issues can go backwards unless an efficient and continuous compliance monitoring
system is implemented.
The ERPA has adapted and established regulatory control system from the beginning in which a continuous and an
effective linked system of Notification, Authorization, Inspection and Enforcement are used for effective control of sources in
the country.
Purpose
This procedure is intended to establish basic/mandatory requirements required for license in General Diagnostic Radiology
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 ERPA by proclamation No. 79/1993. This mandatory regulatory requirements 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, and comply accordingly in very transparent manner.
Scope
This procedure applies to all General Diagnostic Radiology facilities practicing diagnostic imaging application with x-ray
machine for the purposes of obtaining diagnostic information of patients as prescribed by appropriate medical personnel.
Effective date
The provisions of this procedure are effective on the date of 14 Dec 2007 by the approval of the Authority.
NB: It should be emphasized that provisions of all accessories for radiation safety and quality of diagnostic services should
be provided; however, this basic requirements can only serve to indicate mandatory requirements to start the practice and to
get authorization (license). Therefore, additional remarks of the inspection are expected, as deemed necessary.
 II - Safety Provisions, X-                                                                                                 radiography and not
 Ray Premise and Safety          Provision of lead aprons       C.   Lead glass goggle      E. Personal                     less than 28 m2 for
       Control System            with less than 0.50 mm of                                  Monitoring Service for          special   procedures
                                 lead equivalent will be        Lead glass goggles          radiation workers               such as fluoroscopy,
A.   Lead apron,                                                have to be provided for
                                 tolerated for one phase of                                                                 CT-scan, etc.
Lead aprons of 0.50 mm of        inspection and this will be    protection of the eye of    Personal         monitoring
lead (or lead equivalent) are    notified in writing to the     the patient, helpers or     service for all radiation       However,             for
indispensable      for    the    user as part of condition of   radiation workers for       workers       (such      as     radiological facilities
examiner        and       the    the license.                   fluoroscopic and other      radiologists,                   with area of the
radiographer and other staff                                    special procedures.         radiographers          and      exposure room not
involved    as     necessary     B.   Gonad shields                                         darkroom       technicians;     less than 20 m2 for
during           fluoroscopic                                   However, lead glass         besides to all medical          conducting     general
procedures.      Comforters,     Gonad shields of different     goggles will be provided    personnel involved in           radiography and not
children,    and     pregnant    sizes     and      shielding   and used for plain          the     operation       and     less than 24 m2 for
women should be strictly         capacity, at least for         diagnostic      radiology   delivery of radiation to        special procedures, a
provided with lead aprons        standing positions, shall be   practices at the next       patients depending on           transition period of
under      any      exposure     made available to be used      phase of inspection and     the              diagnostic     one inspection phase
circumstances.                   by patients and pregnant       this will be notified in    procedures for example          will be given to
                                 women.                         writing to the user as      interventional radiology)       upgrade the area to
However, it is possible for                                     part of condition of the    shall    be       provided.     the standard sizes;
machines with maximum            However, it is advisable       license.                    Adequate level of dose          and this will be
voltage of up to 100 kV peak     the provision of gonad                                     recording system shall          notified in writing to
to have lead aprons not less     shields for lying positions    D.   Lead gloves            be provided that can            the user as part of
than 0.25 mm lead and            (here, it is assumed that                                  serve as the radiological       condition    of     the
0.35mm lead for above 100        gonad shields available for    Lead gloves shall be
                                                                                            profile of an individual        license.
kV peak only for staff           standing positions will also   provided for operators
                                                                                            radiation worker.
protection          purposes.    be used for lying).            during        fluoroscopy                                   N.B. The exposure
Interventional radiology staff                                  procedures      and    by   F. Area     of           the    room      shall   have
should always use 0.5 mm         Gonad shields integrity        comforters in supporting    exposure room                   sufficient ventilation
lead equivalent wrap-around      (Physical conditions for       the patient.                                                (such as a ventilation
aprons.                          holes, cracks, etc) shall be   Glove integrity (Physical   Area of the exposure            window with a height
Lead     apron(s)   integrity    checked properly.              conditions for holes,       room shall not be less          above      2m     from
(Physical   conditions    for                                   cracks, etc) shall be       than    24    m2    for         outside ground level
holes, cracks, etc) shall be                                    checked properly.           conducting general              and position in such a
checked properly.

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                                                                                                   The Ethiopian Radiation Protection Authority (ERPA)
way that backscatter           exposure room shall be       1. Film hopper         (Light    necessary          documents       Officer (RSO) has to be
radiation will not fall on     provided.    If   special       tight)                        including the service and          officially assigned by the
windows of opposite            procedures like barium       (A film hopper with a            operating manuals, results         organization applying for
building, verandah, etc)       meal is practiced a          pull-back or shutter has         of acceptance tests, and           Authorization and the
                               barium    kitchen    with    to be provided and the           calibration certificate for the    following management
G. Area          of      the
                               required provisions (like,   film hopper shall be light       required              machine      responsibilities have to
Darkroom
                               cabinet, sink, etc) shall    tight.)                          parameters of the x-ray            be        respected       in
Area of the darkroom           be provided adjacent to                                       machine.                           recruiting        radiation
                               the exposure room.           2. Film dryer (that could                                           workers and assignment
shall not be less than                                                                       1. Deviation        of     kVp
                                                               provide uniform drying                                           of an RSO:
6m2.                           III - Safety of the X-                                           Accuracy ≤ ±10%
                                                               of radiographs)
                               ray           Premise        3. Film processor (with          2. Deviation of the X-ray          A. Fixed Radiography
However, there is no
                                                               all necessary items)             timer ≤ ±10%                       where there is no
mandatory of darkroom          (Radiological
                                                            4. Hatch box with an             3. Out put inconsistency ≤            special procedures
area requirements for          protection survey)              inter lock system                5%                                 like I.V.P., Barium
digital film processing
                     

                              The X-ray department                                          4. Collimator         accuracy        meal etc
system or similar IT                                        [A hatch box with an
                               must be safe from                                                (light & radiation field
technologies.                                               interlock system, and               congruency) ≤ ± 2%              At least one formally
                               radiological point of view
For darkroom area not                                       internal dimensions that         5. Beam              alignment      trained           Junior
                               at      every     location
less than 5 m2, a                                           could accommodate the               accuracy                         Radiographer has to be
                               (maximum of 1 µSv/hr at
transition period of one                                    largest      size      film         (perpendicularity         of     available. If there is a
                               all locations occupied by                                        radiation beam) ≤ 30
inspection phase will be                                    cassettes in sufficient                                              higher workload above
                               a member of public and
given to upgrade the                                        number,       must       be      6. Tube and collimator              150 Patients per week
                               6.5 µSv/hr in the control                                        Leakage ≤ 100mR
area to the standard                                        available. Besides, if one                                           (~ 50 mA-min/week)
                               cubicle       and      any
sizes; and this will be                                     side of the hatch box is         7. Evaluation       of    total     then    an     additional
                               occupationally accessed                                          filtration, i.e. HVL (Half
notified in writing to the                                  along the exposure room                                              radiographer has to be
                               location by radiation                                            Value       Layer)      test
user as part of condition                                   it shall be properly                                                 provided
                               workers).
of the license.                                             shielded (lead-lined) to            acceptable for a given          At least one Darkroom
                              Lead glass window shall      avoid radiation exposure            kVp                              technician has to be
H. Wall thickness                                                                            Malfunction of collimator
                               be provided to the           of the films placed in the                                           assigned
Wall thickness of at least     control cubicle, and it      box].                            light and other series
17 cm concrete or its                                                                        mechanical defects shall           B. Fixed Radiography
                               should have a nominal        Provision of hatch box
equivalent     (with    no                                                                   also      be    seriously             where     there   is
                               value of 2 mm lead or its    without interlock system,
radiation leakage to the                                                                     considered:                           special procedures
                               equivalent. The lead         can be tolerated for a
surroundings,          i.e.                                                                                                        like I.V.P., Barium
                               glass shall be fitted at     transition period of one         these includes; looking for
maximum of 1 µSv/hr at                                                                                                             meal, etc
                               proper     location    to    inspection phase         to      loose screw; indicators &
all locations occupied by      provide a clear view (to     upgrade to the required          meter     check;    stability,     At least one formally
a member of the public         the radiographer) of a                                        stiffness of tube hanger,           trained           Senior
                                                            standard         (interlock
and 6.5 µSv/hr to the          patient       undergoing                                      chest stand, etc; conditions        Radiographer has to be
                                                            system); and this will be
control cubicle and any        radiological examination.                                     of movements of locks of            available. If there is a
                                                            notified in writing to the
occupationally accessed                                                                      tubes; checks for control-          higher workload above
                               The wall of the X-ray        user as part of condition
location by radiation                                                                        panel      switches      and        120 patients per week
                               room (exposure room)         of the license.
workers).                                                                                    movement of collimators.            (~ 40 mA-min/week),
                               should be thick enough       5. Light      tight      film
I.   Warning light &                                                                                                             then additional Senior
                               to attenuate (contain)          cassettes            with
signs                          leakage of radiation. The                                     VI - Documentation                  Radiographer has to be
                                                               intensifying      screen                                          provided.
                               wall     thickness      is      adequate       to      the
                                                                                             Requirements
A warning red light                                                                                                             At least one Darkroom
coupled/synchronized           generally suggested to          diagnostic radiological       Full documentation shall be         technician has to be
with the machine power         be 17 cm of concrete            practice.
                                                                                             presented       with      the       assigned.
shall be provided at           (pure) or equivalent, as     6. Radiation level in the
                                                               darkroom shall be very
                                                                                             application for Authorization
appropriate location(s).       an alternative to the                                                                            C. For facilities with
                                                               small and usually in          to the Authority such as:
                               description on the lay                                                                              one or more of such
Placards        containing     out of the X-ray premise.       the       level          of    Machine        specifications       practices       with
international     radiation    A 3 layers of brick             background to ensure            (including manufacturer’s           Fluoroscopic
hazard     sign     (Trefoil   (standard brick density)        the quality of films.           information, maximum and            machines,
symbol) and notices in         is proposed as the                                              minimum parameters that             Mammography
English and Amharic                                         V - X-ray Machine
                               thickness of the wall in                                        could be set, date of               machines,
(or/and     other     local    the direction of the         Performance                        manufacture, etc) and               Angiography
languages) should be           primary beam. All other      Equipment of diagnostic            shipping certificate as             machines and CT
available and posted at        sides can have a             radiology shall conform to         necessary.                          scanners:
suitable locations. Local      thickness of 2 layers of     applicable national or            Floor layout of the facility,
rules should also be                                                                                                            At least one formally
                               brick. Doors adjacent to     international    standards        Copies of educational
presented       describing     the exposure room shall                                                                           trained Radiologist and
                                                            such as the International          qualifications of workers,
working procedures and                                                                                                           a Senior Radiographer
                               be               properly    Electrotechnical                  Properly      signed      and     has to be available. If
safety rules.                  shielded/lead-lined with     Commission (IEC) or                sealed            completed       there is a higher
J. Patient                     lead of 2 mm or its          International Standards            notification & application
                               equivalent       material.                                                                        workload 120 patients
Identification        System                                Organization (ISO).                protocols AP-NT-01 and
                               Lead overlap shall be                                                                            per week (~40 mA-
(Film Printer)                                                                                 AP-DR-01.
                               made to avoid radiation      Such equipment should                                                min/week) and more
Proper              patient                                                                   Operating and maintenance          than two of these
                               leakage      at    edges,    satisfy    the  technical
identification system, like                                                                   instruction shall also be          practices are performed
                               hinges and connections.      requirements           of
film printer shall be                                                                         submitted but it can be            then additional Senior
                                                            verification of machine
provided and routinely         IV - Dark          room                                        made later.                        Radiographer has to be
                                                            parameters, and Quality
used.                          Accessories                  Assurance tests at large.                                            provided.
                                                                                                   VII - Personnel
K.   Auxiliary rooms                                        Under all circumstances,
                               The following darkroom                                              Requirements                 At least one Darkroom
                                                            the equipment should be
Dressing cubicles and          accessories shall be                                                                             technician has to be
                                                            accompanied with the             A Radiation Safety
toilet adjacent to the         provided:                                                                                        assigned.
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