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CES 211-2 - 2021 Advanced Medical Lab
CES 211-2 - 2021 Advanced Medical Lab
ETHIOPIAN STANDARD
Second Edition
03-04-2021
ICS: 11.020
Published by Ethiopian Standards Agency
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TABLE OF CONTENTS
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Foreword
This Ethiopian Standard has been prepared under the direction of the Technical Committee for Medical Science
& Health care practices (TC 90) and published by the Ethiopian Standards Agency (ESA).
This Ethiopian Standard cancels and replaces ES 3609:2012, Advanced Medical Laboratory Requirements.
Application of this standard is COMPULSORY with respect to clause 4 and 5. A Compulsory Ethiopian
standard shall have the same meaning, interpretation and application of a “Technical Regulation “as implied in
the WTO-TBT Agreement.
Implementation of this standard shall be effective as of 03-04-2021.
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ETHIOPIAN STANDARD CES 211-2
4. GENERAL REQUIREMENTS
4.1 The advanced m edical laboratory shall f ull fill the health i nstitutions general requirement specified i n CES
246.
4.2 The A dvanced medical l aboratory shall have a w ell or ganized, adequat ely supervised and staffed clinical
laboratory with the necessary space, facilities and equipment to perform those services commensurate with
the Advanced Medical Laboratory's needs for its patients.
4.3 The laboratory working environment shall be kept organized and clean, with safe procedures for handling of
specimens and waste material to ensure client and staff protection from unnecessary risks at all time.
4.4 The laboratory shall have space allocated so that its workload can be performed without compromising the
quality of work, quality control procedures, and safety of personnel or patient care services.
4.5 The laboratory shall have adequate space and a safe environment to perform testing.
4.6 The laboratory shall provide adequate lighting, ventilation, water, waste and refuse disposal.
4.7 The laboratory precautions shall be taken to prevent cross contamination.
4.8 The laboratory shall provide a suitable environment to prevent damage, deterioration, loss or unauthorized
access.
4.9 The laboratory shall be located and designed to
a) Provide suitable, direct access for patients
b) Allow reception of deliveries of chemicals
c) Allow safe disposal of laboratory materials and specimens.
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5. SPECIFIC REQUIREMENTS
5.1 Laboratory Service
5.1.1 Practices
5.1.1.1 The advanced medical laboratory shall have written quality policies for at least the followings:
a) Organization
b) Personnel
c) Equipment management
d) Purchasing and inventory
e) Documentation
f) Facility and safety
g) Occurrence management
h) Process control
i) Process improvement
j) Information management
k) Internal and external assessment
l) Customer handling
5.1.1.2 The advanced medical laboratory shall have written manuals for at least the followings:
a) Laboratory safety manual
b) Specimen management
c) Laboratory handbook
5.1.1.3 The ad vanced medical l aboratory should ha ve adopt ed/customized gui delines f or at least t he
followings; Safety guideline, TB and HIV
5.1.1.4 The advanced medical laboratory shall have written procedure for at least the followings
a) For all laboratory tests
b) Internal Quality control
c) Inspection, maintenance and operation of all equipment
d) Management of reagents, including availability, storage, and testing for accuracy
e) For co llecting, i dentifying, pr ocessing, t ransportation and di sposing of s pecimens ( Preferred
sample type ( venous, arterial, capillary, urine, spinal fluid, Type of anticoagulant, Sample volume
considered acce ptable, P atient i dentification, Requirements f or pat ient pr eparation and
,Requirements for storage of specimens.
f) Laboratory disinfection, sterilization and waste management
g) Document and record control
h) Method of validation and verification
i) External quality control
j) Selecting and evaluating referral laboratories and consultants
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5.1.1.5 The laboratory shall have periodic calibration report from authorized body as per quality manual.
5.1.1.6 The l aboratory shall ha ve s tandardized dat a co llection i nstruments and i ncluding at l east t he
followings:
a) Laboratory request forms
b) Laboratory report forms
c) Laboratory specimen and results registers
d) Quarterly/monthly reporting including
• Summary of tests conducted
• Summary of tests referred
• Summary of quality assurance report
e) Equipment and supplies inventory registers
f) Quality assurance record forms
5.1.1.7 Policies, manuals and procedures shall be documented, approved and communicated to concerned
personnel.
5.1.1.8 The laboratory shall develop monitoring and evaluation tools to assess activities including:
a) Adherence to SOPs
b) Adherence to safety guidelines
c) Quality assurance activities
d) Laboratory performance and workload
e) Laboratory services
5.1.1.9 The laboratory shall have a policy for making amendments and corrections to laboratory
procedures and all amended laboratory procedures shall be reviewed and approved for use.
5.1.1.10 Test pr ocedures t hat ar e new ly developed, modified and uni ntended us e de veloped by the
laboratory shall be validated and fully documented before being put into use.
5.1.1.11 All procedures shall be in a language commonly understood by laboratory staff.
5.1.1.12 Laboratory management shall review all procedures at regular intervals.
5.1.1.13 Procedures m ay be written by the l aboratory staff or m ay be adapt ed f rom pr eviously published
materials including, but not limited to, product inserts, procedure or instrument manuals, textbooks,
journals, or international guidelines.
5.1.1.14 Laboratory staff s hall t est qualit y control materials a s per m anufactures r ecommendation and
document in combinations suitable to detect analytical error.
5.1.1.15 Request paper for testing shall provide:
a) Name of patient
b) Medical recording number/unique identifier
c) Patient gender
d) Age
e) The name of the ordering physician or other person authorized to order testing
f) The clinician’s working address
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d) Quality assured t est r esults s hall be r eported on s tandard f orms t o t he phys ician w ith t he
following minimum information:
• Patient identification (patient name, age, gender,)
• Date and time of specimen collection
• The test performed and date of report.
• The reference or normal range specific to male and female.
• Method/equipment used
• The laboratory interpretation where appropriate,
• The nam e and initial o f t he per son w ho p erformed t he t est, and aut horized s ignature o f the
person reviewing the report and releasing the results.
• The advanced medical laboratory name and address
e) Laboratory results shall be legible, without transcription mistakes and reported only to persons
authorized to receive them.
f) The laboratory shall have policies and procedures in place to protect the privacy of patients and
integrity of patient records whether printed or electronic. Policies shall be established which
define who may access patient data and who is authorized to enter and change patient results,
correct billing or modify computer programs.
5.1.1.25 When reports altered, the record shall show the time, date and name of the person responsible for
the change.
5.1.1.26 Safe disposal of samples shall be in line with requirements prescribed under CES 246.
5.1.1.27 The laboratory shall post safety signage.
5.1.1.28 No food and drink to be stored in the laboratory
5.1.1.29 The l aboratory s hall ha ve co ntrolled t emperature o f r efrigerator for r eagents, bl ood s ample,
calibrator, control materials which affect the analytical results.
5.1.1.30 Wearing of pr otective clothing of an appr oved design ( splash proof), always f astened, within t he
laboratory work area and removed before leaving the laboratory work area
5.1.1.31 The l aboratory must keep a record o f t he co mplaint. The record s hall include the nat ure of t he
complaint, t he dat e o f occu rrence, individuals involved, any investigations under taken by the
laboratory and resolution.
5.1.1.32 The laboratory shall have controlled temperature of laboratory room and refrigerator for reagents,
blood sample, calibrator, control materials which affect the analytical results.
5.1.1.33 The ad vanced m edical laboratory may have a po licies a nd pr ocedures for pr oviding ad visory
service and clinical case consultancy.
5.1.1.34 The following laboratory tests shall be performed in an Advanced Medical Laboratory.
a) HEMATOLOGY and IMMUNO HEMATOLOGY
• Complete blood count with Differential count
• Peripheral morphology
• Reticulocyte count
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• H.Pylori Test
• RPR (syphilis)
• C-reactive Proteins
• ASO
• RF (Rheumatoid factor)
• Beta HCG
• ANA (Antinuclear Antibody)
• Fecal occult blood test
• Viral infectious tests
g) OTHER TESTS
• Viral load test (HIV, HBV, HCV, HPV,) (optional)
• COVID-19 ( RT-PCR)
• Serum electrophoresis
• OGGT
• Semen Analysis
• Drug test -----optional
5.1.2 Premises
5.1.2.1 Doors shall be l ocated in places where entry and exit is easy and does not interfere with the
laboratory benches or equipment.
5.1.2.2 Laboratory doors shall not be less t han 1 m w ide to allow eas y access of equipment. In some
areas, double doors, 1.2 m wide, shall be provided for passage of large equipment, such as deep-
freezes.
5.1.2.3 All doors shall be opened towards the corridor.
5.1.2.4 There shall be effective separation between adjacent laboratory sections if there are incompatible
activities.
5.1.2.5 The premise for advanced medical laboratory shall have a minimum of the following.
Table 1 – Premises for Advanced Medical Laboratory
S/N Premises Required Number Area
of Rooms Required
1 Reception & waiting area 1 16 sq.m
2 Specimen collection room 1 12 sq.m
3 Hematology 1 36 sq.m
4 Clinical chemistry
5 Serology
6 Flow cytometer
7 Emergency shower
8 Parasitology, urine & body fluid analysis 1 6 sq.m
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l) Emergency of safety services such as deluge showers and eye-wash stations, fire alarm systems
and emergency power supplies shall be included in the laboratory services design specifications
m) Telephone and/or radio communication.
5.1.3 Professionals
5.1.3.1 All laboratory services shall be directed by a licensed medical laboratory technologist with relevant
MSc.
5.1.3.2 Medical laboratory staff shall be present at the advanced medical laboratory to provide laboratory
service at all times.
5.1.3.3 Students and other s taff on at tachment shall w ork under t he di rect s upervision of a licensed
medical laboratory technologist.
5.1.3.4 Laboratory staff shall, at all times, perform their functions with adherence to the highest ethical and
professional standards of the laboratory profession.
5.1.3.5 The following shall be the minimum laboratory staffing requirements.
Table 2 – Professionals Require for Advanced Laboratory Service
Sr.No Professional required Number required
1. Laboratory technologist with Master degree in 1
medical laboratory or related field
2. Laboratory Technologist, 3
3. Laboratory technologist (quality control officer) 1
4. Laboratory technologist (safety officer) 1
5. Laboratory technicians 2
6. Medical advisor(GP/HO)(optional)
7. Supportive staff (clerk, cleaner)
5.1.4 Products
5.1.4.1 All equi pment shall be i n good w orking order, routinely quality controlled, and pr ecise i n terms of
calibration.
5.1.4.2 Laboratory shall establish a programme that regularly monitors and demonstrates proper
calibration and f unction o f i nstruments, r eagents and anal ytical s ystem. I t s hall al so ha ve a
document.
5.1.4.3 When equipment is removed from the direct control of the laboratory or is repaired or serviced, the
laboratory shall ensure t hat it is ch ecked and shown t o be f unctioning satisfactorily before being
returned to laboratory use.
5.1.4.4 Laboratory shall have a docu mented and r ecorded Programme of preventive maintenance whi ch
at a minimum follows the manufacturer’s recommendation.
5.1.4.5 The l aboratory Equipment s hall be maintained i n a safe w orking co ndition. This s hall i nclude
examination of electrical safety, emergency stop devices.
5.1.4.6 Whenever equipment is found to be defective, it shall be taken out of service and clearly labelled.
5.1.4.7 The following m inimum equi pments and co nsumables shall be a vailable i n ad vanced medical
laboratories
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5.2.1.4 A list o f pat hology examination and t issues whi ch r outinely r equire microscopic and or gr oss
examinations shall be developed in advanced medical laboratory by the pathologist.
5.2.1.5 All pathology result reports shall be signed by the pathologist.
5.2.1.6 Signed reports of tissue examinations shall be sent back to the requesting physician to be filed in
the patient's medical record and duplicate copies kept in the pathology service unit.
5.2.1.7 A tissue file paraffin blocks and slides shall be maintained in the laboratory.
5.2.1.8 There shall be quality assurance system for pathological investigations.
5.2.2 Premises
5.2.2.1 The laboratory shall have an organized separate pathology service area including
a) Waiting area
b) Specimen reception and Sectioning room
c) Preparation/tissue processing and staining room
d) Cytology examination room
e) Reading room, as required
f) Chemical Reagent Store(can be shared)
g) Pathologists office
h) Photography room
i) Laboratory staff room with lockers (can be shared)
j) Toilets for staff and patient (male and female) (can be shared)
5.2.3 Professionals
5.2.3.1 The pathology service shall be directed by a licensed pathologist.
5.2.3.2 The pathology service shall have the following staffing
a) Pathologist
b) Laboratory technologist or technician with training in tissue processing
c) Receptionist (can be shared)
5.2.3.3 The maximum number and t ype of technical staff shall be det ermined by the volume and t ype of
work carried out (Workload Analysis).
5.2.4 Products
5.2.4.1 The pathology service shall have the following products:
a) Waiting area:
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• microscope
• metal stools
e) Chemical Reagent Store:
• Fume extractor
• shelf
5.2.4.2 Cytology Examination room:
a) Coach table
b) Microscope
c) Office table
d) Reading table
e) Mobile examination light
f) Rotary chair
g) Locker
5.2.4.3 Office facilities and furniture
5.3 MOLECULAR DIAGNOSTIC SERVICES (OPTIONAL)
5.3.1 Practices
5.3.1.1 The molecular diagnostic unit of the advanced medical laboratory shall have:
a) Genetic tests for persons who have developed a disease
b) Genetic testing for carrier detection
c) Genetic Testing to Predict Disorders
d) Pre symptomatic Testing
e) Disease-Susceptibility Testing
f) Genetic Testing for Familial Tumours
g) Genetic Testing for Individual differential Drug Response
h) Prenatal Testing and Diagnosis
i) Mass-screening for Newborn Infants with Congenital Disorders
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5.3.1.2 The molecular diagnostic unit shall have written policies and procedures and include at least the
followings:
a) Molecular diagnostic unit shall have Procedure manuals, Standard Operating Procedure (SOP),
protocols or guidelines for appropriate testing.
b) Report times for results (Established turnaround time)
c) Procedures for collecting, identifying, processing, and disposing of specimens
d) All normal ranges for all tests shall be stated (if available).
e) Molecular diagnostic unit safety program, including infection control.
f) Availability of paper based or electronic information management.
5.3.1.3 The Molecular diagnostic unit shall have standardized data collection instruments and including at
least the followings:
a) Request forms
b) Report forms
c) specimen and results registers
d) supplies inventory registers
e) The M olecular di agnostic unit s hall ha ve pr ocedures or ( SOP) for pr oper specimen co llection
that address specific collection requirements such as:
f) Preferred sample type (venous, arterial, capillary, urine, spinal fluid)
g) Type of anticoagulant (appropriate type of specimen collection tube)
h) Sample volume considered acceptable
i) Patient identification
j) Requirements for patient preparation and storage of specimens.
5.3.1.4 The r ight pat ient w ith the r ight request f orm s hall be identified dur ing co llection and deliv ery of
result.
5.3.1.5 There shall be SOP or criteria developed for acceptance or rejection of clinical samples.
5.3.1.6 Molecular d iagnostic unit s hall monitor the t ransportation o f s amples t o t he l aboratory such t hat
they are transported, within time frame, within temperature interval specified in the primary sample
collection manual or SOP and in a manner that ensures safety for carrier.
5.3.1.7 The Molecular diagnostic unit shall maintain a record of all samples received.
5.3.1.8 Once a sample is used, it shall be maintained in the Molecular diagnostic unit for a specified
period of time (or as required by regulation) and at a temperature that ensures stability of the
sample in the event the sample is needed for retesting.
5.3.1.9 The report/result issued by the Molecular diagnostic unit shall have reference (normal) ranges
specific for age and gender.
5.3.1.10 Copies or f iles of r eported r esults shall be r etained by the M olecular di agnostic unit such t hat
prompt retrieval of the i nformation i s po ssible. The l ength of time that reported data are retained
shall be 10 years for legal reason minimal errors or loss of patient test results.
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5.3.1.11 Quality assured test results shall be reported on standard forms to the physician with the following
minimum information:
a) Patient identification (patient name, age, gender,)
b) Date and time of specimen collection
c) The test performed and date of report.
d) The reference or normal range (if available)
e) The Molecular diagnostic unit interpretation where appropriate,
f) The name and initial of the person who performed the test, and the authorized signature of the
person reviewing the report and releasing the results.
g) Address of the sample collection site and the testing laboratory.
5.3.1.12 Molecular diagnostic unit results shall be legible, without transcription mistakes and reported only
to persons authorized to receive them.
5.3.1.13 The Molecular diagnostic unit shall have policies and procedures in place to protect the privacy of
patients and integrity of patient records whether printed or electronic.
5.3.1.14 Policies shall be established which define who may access patient data and who is authorized to
enter and change patient results.
5.3.1.15 When reports altered, the record shall show the time, date and name of the person responsible for
the change.
5.3.1.16 Safe d isposal of s amples sh all be i n li ne w ith n ational infection pr evention gui deline and
healthcare waste management directives/guidelines of Ethiopia.
5.3.1.17 There shall not be eating, drinking, smoking or other application of cosmetics in the molecular
diagnostic unit or in any area where workplace materials are handled.
5.3.1.18 Food and drink shall not be stored in refrigerators.
5.3.1.19 Wearing of pr otective clothing of an appr oved design ( splash proof), always f astened, within t he
molecular diagnostic unit and removed before leaving the unit.
5.3.1.20 The molecular diagnostic unit shall have safety guideline. In addition, the Specimen collection site
shall pr otect the environment and publ ic by assuring t he di sposal of w aste i n a l egally and an
environmentally friendly manner.
5.3.2 Premises
5.3.2.1 The m olecular di agnostic unit s hall ha ve a w ell or ganized s pace, f acilities and equi pment t o
perform the required services.
5.3.2.2 The m olecular diagnostic unit working environment shall be ke pt or ganized and cl ean, with safe
procedures for handl ing o f s pecimens and waste m aterial t o ens ure pat ient and staff pr otection
from unnecessary risks at all time.
5.3.2.3 The molecular d iagnostic unit shall ha ve s pace all ocated s o t hat its w orkload ca n be per formed
without compromising the quality of work, and safety of personnel or patient.
5.3.2.4 The molecular diagnostic unit shall be located and designed to
a) Provide suitable, direct access for patients
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5.3.2.6 The Molecular diagnostic unit room shall be separated by wall from the other rooms.
5.3.2.7 The premise of Molecular diagnostic unit shall have a minimum of the following rooms.
Table 3 – Premises for molecular diagnostic services
Premises required No of Area required
room required
Patient waiting area 1 9sq.m
Main specimen collection room 1 6sq.m
Specimen processing Room 1 6sq.m
Amplification room 1 9sq.m
One room for Detection 1 9sq.m
Staff change room 1 6sq.m
Mini store 1 6sq.m
Reporting, recording and 1 6sq.m
result dispatch area
5.3.2.8 Except A mplification and Det ection r ooms t he ot her r ooms ca n be i n one r oom w ith ( full/half)
partition.
5.3.2.9 The Molecular diagnostic unit facilities shall meet at least the following:
a) A reliable supply of running water.
b) At least one s inks shall be pr ovided in each r oom a nd at l east 5000L r eserve tank in ca se of
water interruption.
c) Continuous power supply
d) Working surface covered with appropriate materials
e) Suitable stools for the benches. Bench tops shall be impervious to water and resistant to
moderate heat and the organic solvents, acids, alkalis, and chemicals used to decontaminate the
work surface and equipment.
f) Internal surfaces, i.e. of floors, walls, and ceilings shall be :
• Smooth, im pervious, free from cr acks, cavities, r ecesses, pr ojecting l edges and ot her f eatures
that could harbour dust or spillage
• Easy to clean and decontaminate effectively
g) Closed drainage from sinks (to a septic tank or deep pit)
h) Deep pit to discard contaminated material or access to a simple incinerator
i) Separate toilets/latrines for staff and patients
j) Emergency of safety services such as deluge showers and eye-wash stations, fire alarm systems
and emergency power supplies shall be included.
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k) Telephone communication.
5.3.3 Professionals
5.3.3.1 The molecular di agnostic services s hall be d irected by medical laboratory t echnologist or any
health professional specialized in Medical Genetics or Molecular Biology or Medical Biochemistry
with at least two years of experience.
5.3.3.2 In addition, the molecular diagnostic unit shall have.
a) Two medical Laboratory technologist and
b) Supportive staff (can be shared)
5.3.4 Products
5.3.4.1 The molecular d iagnostic unit s hall be furnished with al l it ems o f equi pment r equired for t he
provision of services.
5.3.4.2 The following minimum equipments and consumables shall be required
a) Equipment
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f) Policies shall be established which define who may access patient data and who is authorized to
enter and change patient results.
5.4.1.14 When reports altered, the record shall show the time, date and name of the person responsible for
the change.
5.4.1.15 Safe d isposal of s amples sh all be i n li ne w ith n ational infection pr evention gui deline and
healthcare waste management guidelines/directives of Ethiopia.
5.4.1.16 No eat ing, dr inking, smoking or ot her appli cation of cosmetics in S pecimen collection s ite work
areas or in any area where workplace materials are handled.
5.4.1.17 No food and drink shall be stored in` the Specimen collection.
5.4.1.18 The Specimen collection site shall have controlled temperature of refrigerator for reagents, bl ood
sample, which affect the analytical results.
5.4.1.19 Wearing of pr otective clothing of an appr oved design ( splash proof), always f astened, within t he
Specimen collection site work area and removed before leaving the Specimen collection site.
5.4.1.20 The Specimen collection site shall have safety guideline. In addition, the Specimen collection site
shall pr otect the environment and publ ic by assuring t he di sposal of w aste in a legally and an
environmentally friendly manner.
5.4.1.21 The S pecimen co llection s ite must ke ep a r ecord o f t he co mplaint. The r ecord s hall include t he
nature of the complaint, the date of occurrence, individuals involved, any investigations undertaken
by the Specimen collection site and resolution.
5.4.2 Premises
5.4.2.1 The Specimen collection site shall have a well organized space, facilities and equipment to provide
services as per the main laboratory needs and clients.
5.4.2.2 The S pecimen co llection s ite w orking en vironment s hall be ke pt or ganized and cl ean, w ith s afe
procedures for handl ing o f s pecimens and waste m aterial t o ens ure pat ient and staff pr otection
from unnecessary risks at all time.
5.4.2.3 The S pecimen co llection s ite s hall ha ve s pace al located s o t hat i ts workload ca n be per formed
without compromising the quality of work, and safety of personnel or patient.
5.4.2.4 The Specimen collection site shall be located and designed to
a) Provide suitable, direct access for patients
b) Allow safe disposal of Specimen collection site materials and specimens.
5.4.2.5 Doors s hall be located in places where entry and exit is easy and does not interfere with the
Specimen collection site benches or equipment.
5.4.2.6 Specimen collection site doors shall not be less than 1 m wide to allow easy access for patients.
5.4.2.7 The specimen collection room shall be separated by wall from the other rooms.
5.4.2.8 The premise for Specimen collection site shall have a minimum of the following rooms:
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Bibliography
Ethiopian Food, medicine and Healthcare Administration and Control Proclamation No. 661/2009
Ethiopian Food, Medicine and Healthcare Administration and Control Regulation No. 189/2010
Health Policy of Ethiopia
Drug Policy of Ethiopia
Commercial Code of Ethiopia
Criminal Code of Ethiopia
Medicines Waste Management and Disposal Directive No 2/2011
Ethiopian National Guideline for Health Waste Management, 2008
Ethiopian Building Proclamation, No.624/2009
National Fire Protection standard
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