CES 211-2 COMPULSORY

ETHIOPIAN STANDARD

Second Edition
03-04-2021

Advanced Medical Laboratory-Requirements

ICS: 11.020
Published by Ethiopian Standards Agency
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TABLE OF CONTENTS

Foreword ......................................................................................................................... iii

1. Scope ....................................................................................................................... 1
2. Normative reference ................................................................................................. 1
3. Terms and definitions ............................................................................................... 1
4. GENERAL REQUIREMENTS ................................................................................... 1
5. SPECIFIC REQUIREMENTS ................................................................................... 2
5.1 Laboratory Service ................................................................................................ 2
5.2 PATHOLOGY SERVICES (OPTIONAL).............................................................. 11
5.3 MOLECULAR DIAGNOSTIC SERVICES (OPTIONAL) ...................................... 15
5.4 SPECIMEN COLLECTION SERVICE (OPTIONAL) ............................................ 18

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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

Advanced Medical Laboratory-Requirements

1. Scope
This E thiopian s tandard covers t he m inimum r equirements for Advanced M edical Labor atory with r espect t o
practices, premises, professionals and products or materials put into use.
These requirements shall be appli cable for all new and exi sting, governmental and non -governmental Advanced
Medical Laboratory.
2. Normative reference
The following documents, in whole or in part, are normatively referenced in this document and are indispensable
for its application. For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments) applies.
CES 246 - Health institutions–General requirement
3. Terms and definitions
For the purposes of this standard the following definitions shall apply.
3.1
advanced medical laboratory
shall mean a medical laboratory facility which provides all range of comprehensive, specialized, and high caliber
medical Laboratory diagnostic services.

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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g) Type of primary sample collected

h) The anatomic site where appropriate
i) The test requested
j) Pertinent clinical information as appropriate for purposes of test interpretation (Clinical Diagnosis)
k) Date and time of sample collection and receipt in the laboratory
l) Name of the laboratory
5.1.1.16 There shall be procedure or criteria developed for acceptance or rejection of clinical samples.
5.1.1.17 Laboratory shall monitor the transportation of samples to the laboratory such that they are
transported, within t ime frame, w ithin t emperature interval s pecified in t he pr imary sample
collection manual or SOP and in a manner that ensures safety for carrier.
5.1.1.18 The laboratory shall maintain a record of all samples received.
5.1.1.19 Laboratory shall have a procedure for storage of clinical samples if it is not immediately examined.
5.1.1.20 Patient samples shall be stored only for as long as necessary to conduct the designated tests (or
other per mitted pr ocedure) acco rding to fixed s torage t imes, and s hall be des troyed safely and
confidentially after storage.
5.1.1.21 Once a sample is used, it shall be maintained in the laboratory for a specified period of time (or as
required by regulation) and at a t emperature that ensures stability of the sample i n the event the
sample is needed for retesting.
5.1.1.22 The advanced medical laboratory shall carry out clinical laboratory examinations including
a) Clinical chemistry
b) Microbiology
c) Hematology
d) Serology
e) Molecular (optional)
f) Pathology (optional)
g) Immuno assay
h) Parasitology
i) Urine and body fluid analysis
5.1.1.23 There s hall be docu mentation o f as sessment and qual ity control o f t he t ests done und er t he
advanced medical laboratory and perform all necessary improvement actions.
5.1.1.24 All Laboratory report
a) Shall have reference (normal) ranges specific for age and gender.
b) Shall be retained by the laboratory such that prompt retrieval of the information is possible. The
length of time that reported data are retained shall be 10 years for legal reason minimal errors
or loss of patient test results.
c) In the case of laboratory tests performed by an outside laboratory, the original report from such
laboratory shall be put together with the ordering laboratory report form.

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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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• Blood group and RH

• CD4 count (optional)
• Coomb’s test (direct and indirect)
• Coagulation profile (PT, aPTT, INR, D-Dimer, Fibrinogen, bleeding time, Cloting time etc.)
• Erythrocytic Sedimentation Rate
b) CLINICAL CHEMISTRY and IMMUNOASSAY TESTS
• Renal function test
• Lipid profile
• Liver function test
• Uric Acid
• Serum electrolyte
• Cardiac tests
• Oncology Tests /Tumor markers
• Fertility tests
• Thyroid Function tests
• Diabetic tests
• Quantitative protein tests ( ASO, RF, ANA, CRP)
• CSF and 24 hr urine protein
c) URINE AND BODY FLUID ANALYSIS
• Urine microscopy
• Urine chemical test
• Body fluid analysis ( cell count , glucose, protein, LDH, AFS, Gram stain)
d) PARASITOLOGY
• Stool Examination(direct and concentration)
• Hemoparasite
• Identification of filarial parasites
• Modified acid fast stain(AFS)
e) MICROBIOLOGY
• Bacterial Culture & DST
• Fungal culture (optional)
• Tuberculosis Culture & DST ( optional )
• Gram Stain
• AFB Stain
• Indian Ink
f) SEROLOGICAL TESTS
• Widal-weli fliex

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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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9 Microbiology : Bacterial culture 1 16 sq.m

10 Microbiology : Fungal culture (optional) 1 6 sq.m
11 Microbiology : sterilization & media 1 9 sq.m
preparation
12 Microbiology : TB culture (optional) 1 30 sq.m
13 Viral load rooms (Amplification, detection) 2 6 sq. m.each
14 Store room 1 12 sq.m
15 Staff changing room with locker 1 6 sq.m
16 Laboratory management 1 9 sq.m
17 Safety & Quality officer office 1 6 sq m
18 Duty room(optional) 1 8 sq m
19 Toilets for patients (Separate, 1 for Male 2 2 sq.m each
and 1 for female)
20 Toilet with shower for staff (Separate for 2 2 sq.m each
Male and female)

5.1.2.6 The laboratory facilities shall meet at least the following:

a) The l aboratory shall have a r eliable supply of r unning water and at l east 5000 L r eserve t ank in
case of interruption.
b) At l east two sinks shall be pr ovided i n each room, one f or general l aboratory use and t he other
reserved for hand washing.
c) Continuous power supply and backup generator in case of power interruption
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, impervious, free from cracks, cavities, recesses, projecting ledges and other features
that could harbour dust or spillage
• Easy to clean and decontaminate effectively
• Constructed of materials that are non-combustible or have high fire-resistance and low flame-
spread characteristics
g) Laboratory furniture is ca pable o f s upporting ant icipated l oading and us es. S paces bet ween
benches, cabinets, and equipment are accessible for cleaning.
h) Lockable doors and cupboards
i) Closed drainage from laboratory sinks to a septic tank
j) Facilities for disposal of contaminated materials and solid waste
k) Separate toilets/latrines for staff and patients

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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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a) Fully automated clinical chemistry analyzer

b) Fully automated hematology analyzer
c) Hormonal assay analyzer
d) Electrophoresis machine (Optional)
e) Viral load machine (optional)
f) CD4 machine(optional)
g) Electrolyte analyzer ( if not included in fully automated chemistry analyzer)
h) Microscope #5
i) Biological safety cabinet
j) Routine Culture and Drug sensitivity accessories (Package)
k) PH meter
l) Digital balance
m) Vortex mixer
n) Micropippet #10
o) Microhematocrit centrifuge(optional)
p) Microhematocrit reader(optional)
q) Differential counter #2
r) Tally counter # 3
s) Deep freezer
t) Centrifuge #3
u) Timer #6
v) Refrigerator #3
w) Distillation unit
x) Bunsen burner #2
y) Autoclave
z) Dry oven
aa) Blood roller/mixer #2
bb) Water bath
cc) Coagulation machine
dd) Shaker
ee) Incubator #2
5.2 PATHOLOGY SERVICES (OPTIONAL)
5.2.1 Practices
5.2.1.1 The pathology unit of the advanced medical laboratory shall have written procedures and protocols
for pathology service.
5.2.1.2 The pathology service shall be available for at least during working hours.
5.2.1.3 All t issues sent f or pat hology examination s hall be s ubjected t o ex amination macroscopically
and/or microscopically by the pathologist.

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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:

• Chairs for customers

b) Gross Room:

• Dissection table with cold and warm water

• Wheeled chair
• Tissue shelf store
• Lidded garbage container
c) Tissue Processing Room:

• Embedding system laboratory tables

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• Tissue processor –vacuum processor and Rotary processor

• Dry air oven
• Refrigerator
• Microtones
• Water bath
• HE staining table
• Fume extractor
• Knife sharpener
d) Microscopy Reading Room:

• 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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b) Allow safe disposal of materials and specimens.

c) Doors shall be l ocated i n pl aces where entry and ex it i s ea sy and d oes not i nterfere with the
benches or equipment.
5.3.2.5 Molecular diagnostic unit doors shall not be less than 1 m wide to allow easy access for patients.

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

• Gel documentation unit • Microwave oven

• Gel Electrophoresis unit • Spinner or mini Centrifuge
• Centrifuge • Water bath
• Ultra Freezer • Thermostat or Heat module
• Fridge with -20 freezer • Shaker
• Pipettes • Vortex
• Electric generator • pH meter/pH strips
• Water purification unit • Analytical balance
• Bunsen burner • PCR work station/laminar flow
• Electric or gas stove • Microbiological incubators
• Autoclave
b) Plastics and glassware

• PCR tubes strips • Storage Boxes

• PCR plates • Tube racks
• Pipette Tips • Petri dishes
• Glass ware
c) Reagents

• DNA/RNA isolation kits • Fragment analysis markers

• DNA/RNA purification kits • Markers and Loading dye
• cDNA synthesis kit • Buffers and Media
• Enzymes/PCR reagents

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d) Computers and softwares

• Laptop computer • DNA protocol

• Desk top computer • RNA protocol
• Printer/fax/copier • Protein Protocol
• Software’s for s equence and f ragment • Genomic sequencing
analysis • Microscope
• Cell culture • IF kit
• Western blot • Microbiology protocol

5.4 SPECIMEN COLLECTION SERVICE (OPTIONAL)

5.4.1 Practices
5.4.1.1 The S pecimen co llection site of t he advanced m edical l aboratory shall have written poli cies an d
procedures and include at least the followings:
a) Procedure manuals, Standard Operating Procedure (SOP) or guidelines for appropriate specimen
collection and transport. (The main laboratory specimen collection and transportation SOP can be
used )
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
e) Specimen collection site safety program, including infection control
5.4.1.2 The Specimen collection site shall have policies and procedures for the availability of paper based
or electronic information management.
5.4.1.3 The Specimen collection site shall have standardized data collection instruments and including at
least the followings:
a) Request forms (regarding its content please refer the advanced medical laboratory service
standards section of this document
b) Report forms ( regarding it s co ntent pl ease r efer t he ad vanced medical laboratory service
standards section of this document
c) specimen and results registers
d) supplies inventory registers
5.4.1.4 The S pecimen co llection s ite s hall get co nsultation f rom t he main Labor atory on selection,
quantification, procurement and storage of supplies.
5.4.1.5 The Specimen collection site shall have procedures or (SOP) for proper specimen collection that
address specific collection requirements such as:
a) Preferred sample type (venous, arterial, capillary, urine, spinal fluid)
b) Type of anticoagulant (appropriate type of specimen collection tube)

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c) Sample volume considered acceptable

d) Patient identification
e) Requirements for patient preparation and storage of specimens.
5.4.1.6 The r ight pat ient w ith the r ight request f orm shall be i dentified dur ing co llection and deliv ery of
result.
5.4.1.7 There shall be SOP or criteria developed for acceptance or rejection of clinical samples.
5.4.1.8 Specimen collection site shall monitor the transportation of samples to the Specimen collection site
such t hat t hey are t ransported, within t ime frame, w ithin t emperature i nterval s pecified i n t he
primary sample collection manual or SOP and in a manner that ensures safety for carrier.
5.4.1.9 There shall be a dedicated transportation system which is free from hazards during transportation.
5.4.1.10 The Specimen collection site shall maintain a record of all samples received.
5.4.1.11 Specimen co llection s ite s hall ha ve a pr ocedure for s torage of cl inical s amples if it is not
immediately transported to the testing facility (main Laboratory).
5.4.1.12 Once a sample is used, it shall be maintained in the testing laboratory 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.
5.4.1.13 Specimen collection site report shall follow:
a) All S pecimen co llection site t est r esult/reports shall have r eference ( normal) r anges specific for
age and gender.
b) Copies or files of r eported r esults shall be r etained by t he S pecimen collection site such t hat
prompt retrieval of the information is possible. The length of time that reported data are retained
shall be 10 years for legal reason minimal errors or loss of patient test results.
c) Quality assured test results shall be reported on standard forms to the physician with the
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
• The Specimen collection site interpretation where appropriate,
• 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.
• Address of the sample collection site and the testing laboratory.
d) Specimen collection site results shall be legible, without transcription mistakes and reported only
to persons authorized to receive them.
e) The Specimen collection site shall have policies and procedures in place to protect the privacy of
patients and integrity of patient records whether printed or electronic.

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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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Table 4:- Premises Required for Specimen Collection Site

Premises required No of room required Area required

Patient waiting area, Reporting, recording and r esult disp 1 12 sq.m
area
Main specimen collection room 1 6sq.m
Specimen processing room 1 9sq.m
Staff change room 1 6sq.m
Mini store 1 6sq.m
Patient toilets( separate Female and Male) 2 2 sq.m each
Staff toilet 1 2 sq.m
5.4.2.9 The Specimen collection site facilities shall meet at least the following:
a) The Specimen collection site shall have a reliable supply of running water.
b) At least two sinks shall be provided in the specimen collection room, and one for Specimen
collection site use and t he ot her r eserved for hand was hing and at l east 1000L r eserve t ank in
case of 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, impervious, free from cracks, cavities, recesses, projecting ledges and other features
that could harbour dust or spillage
• Easy to clean and decontaminate effectively
g) Closed drainage from Specimen collection site 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 in the Specimen collection site services design
specifications
k) Telephone communication.
5.4.3 Professionals
5.4.3.1 All Specimen collection site services shall be directed by a licensed medical Laboratory technician.
5.4.3.2 The following shall be the minimum specimen collection site staffing requirements.
a) Two medical Laboratory technician
b) Supportive staff (clerk, cleaner...)
5.4.4 Products
5.4.4.1 Specimen collection site shall be furnished with all items of equipment required for the provision of
services.

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5.4.4.2 The following minimum equipments shall be required

a) Micropipettes of d ifferent volumes and h) PC and a printer ( if the data
pipette tips management s ystem i s
b) Timer with alarm electronic )
c) Centrifuge i) UPS
d) Refrigerator with timer j) Couch
e) Roller or mixer k) Ice box
f) Specimen co llection tubes of dif ferent l) dedicated vehicle for sample transport (
type it can be outsourced)
g) Specimen co llection cu ps f or ur ine and m) Generator(It can be shared )
stool n) Thermometer

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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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