CES 211-1 - 2021 Basic Lab

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CES 211-1 COMPULSORY

ETHIOPIAN STANDARD

Second Edition
03-04-2021

Basic Medical Laboratory-Requirements

ICS: 11.020
Published by Ethiopian Standards Agency
© ESA
CES 211-1

TABLE OF CONTENTS

FORWORD ................................................................................................................................................ ii
1. SCOPE ............................................................................................................................................ 1
2. NORMATIVE REFERENCE ............................................................................................................. 1
3. TERMINOLOGIES AND DEFINITIONS ............................................................................................ 1
4. GENERAL REQUIREMENTS ........................................................................................................... 1
5. SPECIFIC REQUIREMENTS ........................................................................................................... 2

ii
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CES 211-1

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 3610:2012 Basic 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 211-1

Basic Medical Laboratory-Requirements

1. SCOPE
This Ethiopian standard covers the minimum requirements for Basic Medical Laboratory with respect to practices,
premises, professionals and products or materials put into use.
This requirement shall be applicable for all new and existing, governmental and non-governmental Basic 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. TERMINOLOGIES AND DEFINITIONS
For the purposes of this standard the following definitions shall apply.
3.1
basic medical laboratory
shall mean a medical laboratory institution which provides routine and essential ranges of laboratory tests

4. GENERAL REQUIREMENS
4.1 The basic medical laboratory shall full fill the general requirement specified in CES 246.
4.2 The laboratory working environment shall be kept organized and clean, with safe procedures for handling of
specimens and waste material to ensure patient and staff protection from unnecessary risks at all time.
4.3 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.
4.4 The laboratory shall have adequate space and a safe environment to perform testing.
4.5 The basic medical laboratory shall provide adequate lighting, ventilation, water, waste and refuse disposal.
4.6 The laboratory precautions shall be taken to prevent cross contamination.
4.7 The laboratory shall provide a suitable environment to prevent damage, deterioration, loss or unauthorized
access.
4.8 The laboratory shall be located and designed to
a) Provide suitable, direct access for patients including disability
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 Practices
5.1.1 The basic medical laboratory shall have written quality policies for at least the followings:
a) Organization g) Occurrence management
b) Personnel h) Process control
c) Equipment management i) Process improvement
d) Purchasing and inventory j) Information management
e) Documentation k) Internal and external assessment
f) Facility and safety l) Customer handling
5.1.2 The basic medical laboratory shall have written manuals for at least the followings:
a) Laboratory safety manual
b) Specimen management
c) Laboratory handbook
5.1.3 The basic 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 collecting, identifying, processing, transportation and disposing of specimens(Preferred sample
type (venous, arterial, capillary, urine, spinal fluid, Type of anticoagulant, Sample volume considered
acceptable, Patient identification, Requirements for patient preparation and ,Requirements for
storage of specimens.
f) Laboratory disinfection, sterilization and waste management
g) Document and record control
h) Method verification
i) External quality control
5.1.4 The laboratory shall have standardized data collection instruments and including at least the followings:
a) Laboratory request forms
b) Laboratory report forms
c) Laboratory specimen and results registers
d) Quarterly/monthly reporting forms including
 Summary of tests conducted  Summary of quality assurance report
 Summary of tests referred
e) Equipment and supplies inventory registers
f) Quality assurance record forms

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5.1.5 Policies, manuals and procedures shall be documented, approved and communicated to concerned
personnel.
5.1.6 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
5.1.7 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.
5.1.8 The laboratory shall follow procedures and conduct routine quality assessments to ensure reliable and
cost-effective testing of patient specimens.
5.1.9 Laboratory management shall review all procedures at regular intervals. The frequency should be every
four month (at least annually).
5.1.10 The process of analysis shall be specified by validated written or electronic procedures maintained in
and by the laboratory.
5.1.11 Procedures may be written by the laboratory staff or may be adapted from previously published
materials including, but not limited to, product inserts, procedure or instrument manuals, textbooks,
journals, or international guidelines.
5.1.12 Laboratory staff shall test quality control materials as per manufactures recommendation and document
in combinations suitable to detect analytical error.
5.1.13 The right patient with the right request form shall be identified during collection and delivery of result.
5.1.14 Requests 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
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

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5.1.15 There shall be procedure or criteria developed for acceptance or rejection of clinical samples.
5.1.16 Laboratory shall monitor the transportation of samples to the laboratory such that they are transported,
within time frame, within temperature interval specified in the primary sample management manual or
procedure and in a manner that ensures safety for carrier.
5.1.17 The laboratory shall maintain a record of all samples received.
5.1.18 Laboratory shall have a procedure for storage of clinical samples if it is not immediately examined.
5.1.19 Patient samples shall be stored only for as long as necessary to conduct the designated tests (or other
permitted procedure) according to fixed storage times, and shall be destroyed safely and confidentially
after storage.
5.1.20 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 temperature that ensures stability of the sample in the event the sample
is needed for retesting.
5.1.21 The basic medical laboratory shall carry out clinical laboratory examinations including
a) Clinical chemistry,
b) Microbiology(optional)
c) Hematology ,
d) Serology ,
e) Parasitology ,
f) Urine and body fluid analysis,
g) There shall be documentation of assessment and quality control of the tests done under the basic
medical laboratory and perform all necessary improvement actions.
5.1.22 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.
d) 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 specific to male and female.
 Method/equipment used
 The laboratory interpretation where appropriate,

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 The name and initial of the person who performed the test, and authorized signature of the person
reviewing the report and releasing the results.
 The basic 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.
5.1.23 When reports altered, the record shall show the time, date and name of the person responsible for the
change.
5.1.24 Safe disposal of samples shall be in line with standards prescribed under CES 246.
5.1.25 The laboratory shall post safety signage.
5.1.26 No food and drink to be stored in the laboratory
5.1.27 The laboratory shall have controlled temperature of laboratory room and refrigerator for reagents,
blood sample, calibrator, control materials which affect the analytical results.
5.1.28 Wearing of protective clothing of an approved design(splash proof), always fastened, within the
laboratory work area and removed before leaving the laboratory work area
5.1.29 The laboratory must keep a record of the complaint. The record shall include the nature of the
complaint, the date of occurrence, individuals involved, any investigations undertaken by the laboratory
and resolution.
5.1.30 The laboratory shall have periodic calibration report from authorized body as per quality manual.
5.1.31 There shall be a written chemical hygiene plan that defines the safety procedures to be followed for all
hazardous chemicals used in the laboratory. The plan defines at least the following:
a) The storage requirements
b) Handling procedures
c) Requirements for personal protective equipment
d) Procedures following accidental contact or overexposure
e) The plan is reviewed annually, and updated if needed, and is part of new employee orientation and
the continuing education program.
5.1.32 The following shall be range of tests to be performed in Basic Medical Laboratory
a) HEMATOLOGY
 Complete blood count with differential
 Hemoparasite
 Blood group &RH
 Peripheral morphology (optional)
 PT/PTT/INR (optional)
 Erythrocytic Sedimentation Rate (ESR)

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b) CLINICAL CHEMISTRY at least the following


 Liver function test  Uric Acid
 Renal function test  Serum electrolyte
 Lipid profile
 Glucose

c) URINE analysis
 Urine chemical examination
 Microscopic examination
d) BODY FLUID ANALYSIS
 Cell count
 Protein and glucose
e) PARASITOLOGY
 Stool Examination
 Oncocerchiasis (optional)
 Leshimaniasis (optional)
f) BACTERIOLOGICAL EXAMINATION
 Gram Stain  Routine Bacteriologic Culture & DST*
 AFB Stain (optional)
 Indian ink  KOH
g) SEROLOGICAL TESTS at least the following
 Widal-weli fliex  C-reactive Proteins
 HBsAg  ASO
 H.Pylori  RF(Rheumatoidfactor)
 HCV  Toxoplazma
 RPR (syphilis)  HCG
5.2 Premises
5.2.1 Doors shall be located in places where entry and exit is easy and does not interfere with the laboratory
benches or equipment.
5.2.2 Laboratory doors shall not be less than 1 m wide to allow easy access of equipment. In some areas,
double doors, 1.2 m wide, shall be provided for passage of large equipment, such as deep-freezes.
5.2.3 There shall be effective separation between adjacent laboratory sections if there are incompatible
activities.
5.2.4 The following shall be minimum space for basic medical laboratory;

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Table 1 – Premises for Basic Laboratory Service


Premises required No of rooms Area required
required
Reception & waiting area 1 12sq. m
Specimen collection room 1 6 sq. m
Hematology room 1
Clinical chemistry room 1 24 sq.m
Serology room 1
Parasitology, urine & body fluid analysis room 1
Recording and reporting room 1
AFB, Gram stain and KOH 1 6
Shall be separate room
Medical Microbiology rooms (Bacteriologic As per advanced medical
Culture & DST*(optional) laboratory culture room requirement
Disinfection, Sterilization room 1 6 sq. m
Store room 1 6 sq. m
Staff room and office 1 9 sq. m
Laboratory head and quality officer room 1 6 sq. m
Toilets for patients (Separate, Male 2
and female)
Toilet with shower for staff (Separate for 2
Male and female)
Incinerator with ash pit

5.2.5 The laboratory facilities shall meet at least the following:


a) The laboratory shall have a reliable supply of running water. At least two sinks shall be provided in
each room, one for general laboratory use and the other reserved for hand washing and reserve
tank in case of interruption.
b) Continuous power supply and backup generator in case of power interruption
c) 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.
d) 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 harbor dust or spillage
 Easy to clean and decontaminate effectively

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 Constructed of materials that are non-combustible or have high fire-resistance and low flame-
spread characteristics
e) Laboratory furniture is capable of supporting anticipated loading and uses. Spaces between
benches, cabinets, and equipment are accessible for cleaning.
f) Lockable doors and cupboards
g) Closed drainage from laboratory sinks to a septic tank
h) Facilities for disposal of contaminated materials and solid waste
i) 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
j) Telephone communication.
5.3 Professionals
5.3.1 Basic medical laboratory shall be directed by a licensed medical laboratory technologist/MSc in
laboratory science.
5.3.2 Medical laboratory staff shall be present at the basic medical laboratory to provide laboratory service at
regular working hours.
5.3.3 Students and other staff on attachment shall work under the direct supervision of a licensed medical
laboratory technologist.
5.3.4 Laboratory staff shall, at all times, perform their functions with adherence to the highest ethical and
professional standards of the laboratory profession.
5.3.5 the laboratory shall have the following professionals
Table 2 – Professionals Required for Basic Laboratory Service
Sr.No Professional required Number required
1 Laboratory Technologist/Msc laboratory 2
2 Full time quality control officer 1
(Laboratory technologist)
3 Laboratory technicians 2
4 Health officer/Nurse for counselling (optional) 1
5 Supportive staff (clerk, cleaner)

5.4 Products
5.4.1 All equipment shall be in good working order, routinely quality controlled, and precise in terms of
calibration.
5.4.2 Laboratory shall establish a programme that regularly monitors and demonstrates proper calibration and
function of instruments, reagents and analytical system. It shall also have a document.
5.4.3 When equipment is removed from the direct control of the laboratory or is repaired or serviced, the
laboratory shall ensure that it is checked and shown to be functioning satisfactorily before being returned
to laboratory use.

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5.4.4 Laboratory shall have a documented and recorded Programme of preventive maintenance which at a
minimum follows the manufacturer’s recommendation.
5.4.5 Equipment shall be maintained in a safe working condition. This shall include examination of electrical
safety, emergency stop devices. Whenever equipment is found to be defective, it shall be taken out of
service and clearly labelled.
5.4.6 The following minimum equipments and consumables shall be available in basic medical laboratory.
a) Automated clinical chemistry analyzer h) Automatic Micropippet #5
b) Electrolyte analyzer i) Automated Hematology analyzer
c) Microscope #2 j) Centrifuge #2
d) Biological safety cabinet (optional ) k) Timer #3
e) Routine Culture and Drug sensitivity l) Refrigerator #2
accessories (Package) (optional) m) Thermometer #4
f) PH meter #2 (optional ) n) Bunsen burner
g) Digital balance o) Autoclave #1
p) Dry oven #1 r) Incubator (Optional)
q) Shaker

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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

10 © ESA
Organization and Objectives
The Ethiopian Standards Agency (ESA) is the national standards body of Ethiopia
established in 2010 based on regulation No. 193/2010.ESA is established due to the
restructuring o f Q uality a nd S tandards A uthority o f Ethiopia ( QSAE) w hich w as
established in 1970.

ESA’s objectives are:-

 Develop Ethiopian standards and establish a system that enable to


Ethiopian Standards Agency
የኢትዮጵያ የደረጃዎች ኤጀንሲ

check whether goods and services are in compliance with the


required standards,
 Facilitate the country’s technology transfer through the use of
standards,
 Develop national s tandards for local products and se rvices so as to
make them competitive in the international market.
Ethiopian Standards
The Ethiopian Standards are developed by national technical committees which are
composed of different stakeholders consisting of educational Institutions, research
institutes, government organizations, certification, inspection, and testing
organizations, regulatory bodies, consumer association etc. The requirements and/
or recommendations contained in Ethiopian Standards are consensus based that
reflects the interest of the TC representatives and also of comments received from
the public a nd other sources. Ethiopian Standards are approved by t he National
Standardization Council and are kept under continuous review after publication and
updated regularly to take account of latest scientific and technological changes.
Orders f or a ll Ethiopian Standards, I nternational Standards and ASTM standards,
including electronic versions, should be addressed to the Documentation and
Publication Team at the Head office and Branch (Liaisons) offices. A catalogue of
Ethiopian Standards is also available freely and can be accessed in from our
website.
ESA has the copyright of all its publications. No part of these publications may be
reproduced in any form without the prior permission in writing of ESA.
International Involvement
ESA, representing Ethiopia, is a member of the International Organization for
Standardization ( ISO), and Codex Alimentarius Commission ( CODEX). It also
maintains close working relations with the international Electro-technical
Commission (IEC) and American Society for Testing and Materials (ASTM).It is a
founding member of the African Regional Organization for Standardization
(ARSO).

More Information?
Contact us at the following address.
The Head Office of ESA is at Addis Ababa.

 011- 646 06 85, 011- 646 05 65


 011-646 08 80
 2310 Addis Ababa, Ethiopia
E-mail: info@ethiostandards.org,
Website: www.ethiostandards.org
Standard Mark

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