LABORATORY

1. INTRODUCTION
Medical Laboratory Technology is extremely important for the student as it paves the way
to easily understand various medical/ biological professional courses such as
Hematology, Bacteriology, Urine analysis, Parasitology and others. Hence, great
emphasis should be given to this subject matter so as to train qualified, competent and task
oriented medical laboratory technologists.

The Medical Laboratory Technology is a basic subject that equips the student with the
most essential knowledge and skill pertaining to medical laboratories such as:

• Importance of laboratory services;

• Role of Medical Laboratory technologist;
• Use of laboratory wares, instruments and sterilization techniques;
• Prevention and control of laboratory accidents and;
• Institution of quality control system.

2. HISTORY OF MEDICAL LABORATORY SCIENCE

It is difficult to exactly say when and where medial laboratory science was started.
However, some early historical references have shown that there was
examination of body fluid around the era of Hippocrates. The most important event that
contributes for the development of the profession was the discovery of microscope by a
German scientist Antony Van Leoun Hook. Previously one cannot talk about the
field of medical laboratory science without also talking about the medical
specialty of pathology. Early laboratory practitioners were physicians, pathologists .
But sooner medical laboratory profession was developed into a separate discipline having g
its own educational requirements and standards. In Ethiopia, the Italians were the
first to establish health laboratory during The Second World War. Immediately after
independence, a British Scientists took over health laboratory activity in Addis Ababa. They
organized the laboratory under the name of Imperial Medical Research Institute.

3. ROLE OF MEDICAL LABORATORY TECHNOLOGIST

SCOPE
Good Clinical Laboratory Practices should be used by all laboratories where tests are done on
biological specimens for diagnosis, patient care, disease control and research such as:
• Microbiology & Serology
• Hematology & Blood Banking
• Molecular Biology and Molecular Pathology
• Clinical Pathology

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• Clinical Biochemistry
• Immunology (Immunohematology and Immunobiochemistry)
• Histopathology/Pathology and Cytology

In general, the laboratory services are integrated with the 3-tier public health system at
the primary, secondary and tertiary levels. Besides these, there are Reference Laboratories and
Specific Disease Reference Laboratories to provide services for complex and special tests. The
private sector provides laboratory support at all levels of health care both in rural and urban
areas. Each laboratory should identify the scope, functions and the capacity of the services
offered by it and appropriate infrastructure with requisite biosafety measures should be planned.
Qualified and trained staff should be employed with periodic up-gradation of their skills.

Primary Level Simple laboratory tests such as haemoglobin estimation and urine
examination for albumin and sugar are carried out at Primary Health Centers (PHCs) and Urban
Health Centers (UHCs) by laboratory technicians. Most PHCs and UHCs also have microscopy
facilities and trained technicians for examining blood smear for malarial parasite and sputum for
acid-fast bacilli (AFB) and a cold chain system. The Community Health Centers (CHCs) receive
referrals from PHCs and the laboratory technicians are trained and equipped to handle additional
laboratory investigations for the management of medical and surgical emergencies and making
etiological diagnosis of RTIs/STIs.

Facilities for screening of G6PD deficiency, sickle cell anaemia and thalassemia are also
available for vulnerable communities. Under IDSP, training will be provided for diagnosis of
typhoid using kits, detection of chlorination levels and fecal contamination in water samples.

Secondary level - The district hospitals have facilities and manpower for carrying out pathology,
clinical pathology, biochemistry, serology, and microbiological investigations. They also carry
out tests of water quality and receive referrals from primary level facilities. The laboratory staff
includes pathologists, microbiologists, cytotechnicians, laboratory technicians, blood bank
technicians and laboratory attendants.

Tertiary level - The medical college hospitals and non-teaching large hospitals are equipped with
sophisticated diagnostic and investigative facilities to provide tertiary level health care. These
hospitals receive referrals from the primary as well as the secondary levels.

The Reference Laboratories, Research Laboratories and Specific Disease Reference Laboratories
provide services in a specialized field or area of importance. These may be located in a medical
college, research institution or a private institution. They set and should maintain high standards
of quality in one or more particular area and therefore receive referrals specific to that field.

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They also offer consultancy, standardize diagnostic tests and carry out training pertaining to that
specific area.

4. USE OF LABORATORY WARES, INSTRUMENTS AND STERILIZATION

TECHNIQUES

INFRASTRUCTURE
Infrastructure of laboratories should be planned according to the services provided by the
laboratory. The basic infrastructure facilities include: Reception room/area where requisition
forms are received and reports disbursed, Specimen collection room/area, toilets, privacy for
special purposes eg. Semen, fecal and urine collection, facilities for disabled persons, toilet for
staff, Quality water supply for analytical purpose, Uninterrupted power supply, Analytical
work area, Specimen/Sample/slide storage facility including cold storage where applicable ,
Record room/area, Facility for cleaning of glassware, sterilization /disinfection, Waste disposal
facility including biomedical wastes, Fire-safety equipment , Ventilation, climate control and
lighting arrangements, Separate room/area for meetings/administrative work, Separate
facilities/area for staff for hand washing, eating and storing food, drinks etc., Communication
facility with referral centers, Transport of specimen/samples to referral centers, Additional
infrastructure facilities may be added for special tasks as and when needed.

PERSONNEL, TRAINING AND DEVELOPMENT

Each laboratory should designate a Head of the laboratory who should be overall in-charge of the
daily functioning of the laboratory including administration. A Quality Manager should be
designated for monitoring and maintaining of day-to-day quality management system.

The qualifications and experience of the staff outlined in NABL document 112 (2007) should be
followed unless specified by the health care providers. The strength of staff employed should be
appropriate to the level of facility and the workload. The roles and responsibilities of the staff
should be clearly outlined. The staff should also understand the nature of work assigned to them
and must be capable of performing the tasks independently beyond routine working hours if the
need arises. A programme for technical training and updating of skills on a regular basis should
be in place. The laboratory management should be committed for providing continuing
professional development and training opportunities to staff.

Action plan for improvement in the laboratory should be determined and revised according to the
feedback received from previous trainings and experiences. Laboratory should organize or
conduct periodic staff evaluation, preferably once a year; frequency and method of evaluation
should be decided by the laboratory.

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The laboratory should maintain a personal file of all the technical and nontechnical staff
employed. Personal file should contain all information on: Personal bio-data including
educational qualification and experience, Copy of degree/diploma and registration with state
authority if applicable, Copy of appointment letter, Duly verified health information (physical
fitness including color blindness, immunizations received etc.) prepared at the time of
employment and its regular updates, Performance appraisal, Training certificates,
awards/recognition received, Disciplinary action if any taken by the management, Reference
letter from previous employer if applicable

EQUIPMENT
Each laboratory should prepare an exhaustive list of equipment and consumables required and
available for general functioning of the laboratory and specialized equipment for special tests.
Laboratory equipment should be of adequate capacity to meet work load requirement.

Equipment should be suitably located in the laboratory so as to allow accessibility and sequential
utilization thus minimizing the need for frequent movement of specimens or reagents. All
equipment should be in good working condition at all times. Periodic inspection, cleaning,
maintenance of equipment should be done. An equipment log book should be maintained for all
major equipment. Laboratories should maintain necessary instructions for operation and
maintenance of equipment in the form of Standard Operating Procedures (SOPs). A copy of SOP
should be readily available. Maintenance contracts including warranty cards, telephone numbers
of staff to be contacted in case of equipment malfunction should be kept safely. User manual
should be available readily for reference. The staff should be aware of trouble shooting measures
to be adopted for preventing equipment malfunction. A format of the equipment log book can be
used. New equipment should be calibrated and validated before routine use. AMR (Analytical
Measurement range) should be verified, manufacturer can be consulted for verification and
selection of range. Periodic performance check/calibration check for all equipment should be
done using reference standard/reference material. The frequency of performance check should be
based on the day-to-day performance of the equipment. Equipment performance should be
verified from Internal Quality Control results and External Quality Assessment results.

Standard buffer solutions bought from reputed manufacturers with certifiable traceability can be
used as alternative. • Equipment measuring pressure, temperature, humidity etc. should be
checked by using suitable reference standards.

REAGENTS AND MATERIALS

Standard reagents of certified quality must be used for the purpose of analysis. The batch number
of reagents must be recorded. The quality of the reagent viz. Analar grade, HPLC grade, etc. to
be used for in-house procedures should be defined in SOP. The reagents, chemicals and
consumables should be stored under appropriate environmental conditions. Quality of newly

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purchased reagents should be validated against suitable control/reference material prior to use.
Validation data should be properly documented. In-house prepared reagents should also be
checked periodically for stability and a record of the same should be maintained.

Microbiology laboratories should check activity/potency of each lot of antibiotic sensitivity discs
before using and at least weekly thereafter with reference strains. Other microbiological
consumables such as strips etc. used for identification should be checked against reference
strains. Laboratories testing microbiology specimens should check the quality of media by using
appropriate reference strain and pH of the media. All batches of culture containers should be
checked for sterility before issuing to patients for collection of specimen. Water quality should
be checked for its grade and presence of interference elements.

SPECIMEN COLLECTION
Specimen collection is the first phase of interaction between the patient and the laboratory.
Appropriate counselling should be done before specimen collection and consent taken whenever
needed. Attention should be paid to patient's sensibilities during the entire process. Any error in
specimen collection can lead to erroneous results. It is therefore considered an important step of
good clinical laboratory practice and is referred to as "preanalytic control". Laboratory should
have a "primary specimen collection manual", containing information on patient preparation
before specimen collection (if any), exact methodology of specimen collection, labelling,
handling, transportation and storage of the specimens. In addition, the laboratory should provide
adequate and appropriate information/instructions to patients wherever necessary. All
preanalytical factors that may influence the test results should be identified. The manual should
include guidelines on specimen collection including preservation for histopathological
examination. These manuals should be available for reference and should be used for training of
staff engaged in specimen collection. Specimen should be secured properly so that there is no
leakage, spillage or contamination. A Biohazard symbol should be used on the containers during
transportation. Appropriate specimen transportation kit (such as use of dry ice, etc.) to be used
wherever required. Specimen should be sent to the laboratory along with the requisition form.

REQUISITION FORM
The requisition form should be completed by the doctor requesting the tests and sent along with
the specimen/patient to the laboratory. It should contain the patient's identity, age, location, date
of specimen collection and the investigations requested. The referring doctor should be
encouraged to mention the provisional or working diagnosis and relevant clinical and treatment
history in the space provided.

Accession list is a record of all the specimens received by the laboratory for analysis and is
prepared by the laboratory at the time of specimen receipt. It records the patient's identity

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including name, age, sex, location in the hospital/ medical facility, name of referring physician,
investigations requested, date and time of receipt of specimen and condition of the specimen at
receipt. The laboratory assigns a unique laboratory number to register each specimen received,
which can be used to trace the specimen in the laboratory. The test results and remarks if any are
also entered in the accession list.

WORKSHEET
Worksheet is essentially a form provided to the analyst along with the specimen. The following
details should be recorded on the worksheet: Date of analysis Condition of the specimen before
starting analysis (should be entered in the laboratory notes) Findings and result Name and
signature of the analyst (In case of electronically generated and maintained worksheets,
appropriate control, validation and access procedures should be built in the system). Laboratory
number assigned to the specimen should be mentioned in the worksheet before sending the
specimen to the analyst. The specimen should be analyzed according to the plan mentioned in
the SOP. Any deviations from the analysis plan should be mentioned giving reasons.

REPORTING TEST RESULTS

Test results approved and signed by the designated authority should be made available to
authorized person(s) only. Results should be reported clearly, without any errors, specifying
measurement procedure where appropriate and units of measurement as recommended by
professional societies such as International Council for Standardization in Haematology,
International Society of Haematology & International Federation of Clinical Chemistry and
Laboratory Medicine. A format for reporting results is given is need to be used.

DATA MANAGEMENT
Laboratory data management includes recording details of the patient, findings of analysis,
reporting of results and archiving the data for future reference. Recording data allows smooth
functioning of the internal quality control measures, internal audit and external quality
assessment. From the point of view of management, absence of record implies that the work was
never done. The format of recording and reporting results should be described in the Standard
Operating Procedures (SOPs). Data entry should begin as soon as registration number is
assigned to the specimen. Further entries should be made in the accession list and worksheet.
The final report should be recorded after approval/signature of the designated authority.

The laboratory should maintain raw test data preferably for one month in noneditable format or
signed printed copy. Procedure for adequate data protection and security including data editing
and deleting should be developed and maintained by the laboratory. Authorization for
amendment procedure should be specified in the SOP. The laboratory should also record reason
for editing or deleting data. Facilities sending reports electronically should include electronic
signature of the authorized signatory. Laboratories should be able to provide critical information

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required by a physician on telephone eg. frozen section biopsy report is required while operating
a patient with suspicion of cancer or growth of a particular organism in culture can aid in early
diagnosis and treatment.

STANDARD OPERATING PROCEDURE (SOP)

SOP is a document, which contains detailed, written instructions describing the stepwise process
and technique of performing a test or procedure in the laboratory. SOP helps to ensure
uniformity, consistency and control over the processes carried out. It ensures that the procedures
are done in exactly the same way each time irrespective of the operator. SOP should contain
information on who can perform the test, their qualification and training, how to carry out the
test including pre-analytical, analytical and post-analytical stages of test/procedure, laboratory
conditions required for the test/ procedure, routine care and maintenance of equipment,
precautions and safety instructions, trouble shooting measures, waste disposal and linkage with
reference laboratories.

SOP should be simple and written in an easy to understand language. The procedure described
in the SOP must be followed exactly by all staff members to ensure high quality results.

It should be titled along with version number, dated and signed by an authorized person and
updated regularly. It is important for the SOP document to be readily available in the working
area and is therefore also referred to as 'laboratory bench work manual'. SOPs are controlled
documents and can be changed only with approval of the laboratory quality manager and/or
Head of the laboratory

5. ARCHITECTURE OF LAB

It is imperative that laboratory planning must be designed exclusively and permanently for any
one pattern or type of research work. The focus of research is constantly changing. It should be
expected that the direction of the facility's research program may change between design and
activation.
The design of a laboratory is a response to four major challenges:
a) Flexibility: The nature of research can change in unpredictable ways. It is important to
assess the kind and extent of flexibility that can be rationally planned while considering
ADA guidelines.
b) Safety: High risk factors to researchers include possible contamination from specimens,
explosion, and exposure to chemicals
c) Quality of Environment: The presence of natural light, pleasing colors, and a quiet
environment within the laboratory enhance productivity.
d) Cost Efficiency: Assuring quality facilities while maintaining cost efficiency is a strong VA
goal.

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Laboratory Space Planning
There are two plan options: the open plan versus the closed plan. The open plan reduces
construction costs (requiring fewer walls), improves square footage efficiency, and is oriented
toward research teams. The closed plan allows tighter security and provides containment.

Modular Design
In order to achieve flexibility, the design must be planned in terms of a basic planning concept,
"the lab module". The module establishes a dimensioned method by which building systems,
partitions, and casework work well together within the new or existing building structural
framework.

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