LABORATORY SERVICES

Laboratory

It is a place of work for

testing patient’s sample
for results,
in favour of diagnosis and
treatment
Functional Components

Hematology
Chemical Pathology
Clinical Pathology
Histopathology
Microbiology
Clinical Research
Labs

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Hematology

Study of blood and blood

components for detection of
various abnormalities in
normal and ill health
Basic Tests include:
– CBC
– ESR
– Hb test
– WBC
– Prothrombin time
– Coombs test
4
 Chemical Pathology
( Biochemistry)
– Measurement of
chemical substances
in disease process
– Clinical substances
Hormones
Enzymes /Isoenzymes
Vitamins
Other metabolites

5
Clinical Pathology
Examining all body fluids
– Blood
– Urine
– Sputum
– Stool
– Pleural/peritoneal fluid

– Physical
– Chemical
– Bacteriological
– Microscopic
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 Histopathology

Study of Organ,
tissues & cell for

Surgical specimen, biopsy or autopsy

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Microbiology

Study of microbes
(bacteria/virus/parasites)
for
– Culture Studies
– Serology & sensitivity
of organisms responsible for
causing disease

8
 TYPES OF LABORATORY

OPD Laboratory (central)

Ward Laboratory (routine/bedside)
Emergency services Laboratory (round the
clock)
 Planning & Organization

To maximize the effectiveness and

efficiency of operations, lab must have:
– Adequate physical facilities
– Appropriate Equipments
– Adequate number of qualified staff
– Regular supply of standard reagents/chemicals
– Research & Training
 PHYSICAL FACILITIES

Clinical laboratory
Wash rooms
Store room
Reagent preparation room
Staff room
Library
Toilets
Conference room
 Functional considerations
65-90% Square Footage area
Scope of expansion
LIS
Lab Safety against fire, biological toxic waste etc.
Traffic flow planning (intra lab traffic separated
from outside traffic)
Schematic flow of specimen & data
Emergency sample processing
Accessible to ICU and Emergency
 Equipments
All vital equipments should be in duplicate
for providing uninterrupted services.

- Water bath - Incubator

- Centrifuge - Microscope
- Weighing Scale - Photo calorimeter
- Micropipette - Ph-meter
- Autoclave - Microtome
- Hot air oven - ELISA Reader & Washer
- Automated biochemistry Analyzer
- Automated hematology Analyzer
 STAFF REQUIREMENT
Average investigation/day/technical staff:
Standard time = Total Basic Time + Time allowance
a) Total basic time = Total average basic time of job element
Basic time = Average observed time x Rating
b) Time allowance = Contingency allowance + relaxation time
Contingency allowance = 5% of total basic time
Relaxed Time = 12% of basic time

Day functioning technical staff = 36 hrs per week

Observed work/day/technical staff = 60-70 tests/day

 LABORATORY HAZARDS

Handling of infectious material

Handling of broken glassware
Accidental spillover of corrosive reagents
Swallowing of corrosive material
Inhalation of poisonous fumes
Inflammable material / gas leakage
 Safety Precautions
Avoid Mouth pipetting
Avoid eating/ drinking/ smoking
Adequate training of laboratory staff on safety
procedures
Immunization of staff against diseases and
periodic medical check-ups
Adequate and constant water supply
Ample space and illumination
Proper labeling and storage of reagents
Decontaminate Working area
Protective clothing
Personal hygiene
Ensure proper biomedical waste handling
Regular medical check up personnel
Safe laboratory procedures
Wash hands with soap and water
Use of gloves
 LABORATORY WASTE

General Waste
Pathological Waste
Chemical Waste
Infectious Waste
Radio-active Waste
Sharps
 MANAGEMENT OF
LABORATORY WASTE

Collection and segregation at storage

site
Storage and disinfection
Transportation
Disposal
PROBLEMS OF MANAGEMENT
Shortage of trained staff
Lack of technical knowledge among working
personnel.
Low morale/ Lack of job satisfactions
Lack of quality control and standardization
Substandard / delayed receipt of reagents.
Non-functional equipment
Non-availability of modern technology
Lack of medical audit
Different kind of malpractices
Communication gap
 QUALITY ASSESSMENT

To ensure that purpose of performing a test is not

defeated due to unreliability of result

QUALITY ASSURANCE
QUALITY CONTROL
 Quality Control

A surveillance process in which action of

people and performance of equipment and
material are observed, to ensure consistent
performance.
Measures degree of precision in lab
procedures
Main focus on:
- Technical
- Procedural
- Process
Internal QC: performed by individual lab at
their own level.
• Forms basis of day to day work of quality control.
• Aims at improving performance of single lab during
day to day operation.

External QC: performed by many laboratories

at the same time and monitored by one.
• There is periodic monitoring for the performance of
laboratory.
• No direct influence on the output of lab on the day
of test
• Ensures acceptable basis for inter-lab compatibility
 Quality Assurance
Continuous process of assuring that all
laboratory services have been
accomplished in a manner appropriate to
maintain excellence in medical care.
Deals with outcome
3 steps:
- Pre-analytic
- Analytic
- Post-analytic
PRE - ANALYTIC ANALYTIC POST ANALYTIC

Patient preparation Sample Transcription of

preparation report

Specimen collection
Analytic Process Transmission of
report
Procurement Of
sample Examination and Interpretation of
diagnosis report
Sample Accession

Doctor / Patient
satisfaction
 Pre- analytic Errors
Consent form missing
Requisition is incomplete/ incorrect
Incorrect specimen container
No specimen is collected/received
Specimen tube is not labeled
Specimen tube is mislabeled
Clotted specimen
Insufficient quantity of specimen
Specimen contamination
Transport problem
Specimen is lost/delayed in lab
Failure of lab to add or change a test request
Data entry error when logging in a specimen
 Post Analytical Errors

Critical result not informed

Critical result, unable to contact care provider
Delay in reporting
Result reported to wrong provider
Incorrect result reported due to data entry error
LIS problem
Failure of care provider to retrieve lab result
Misinterpretation of lab result by care providers.
 Total Quality Management
Increases the efficiency and effectiveness of
health care services
A management approach based on
participation of all members, aiming at long
term success through customer satisfaction.
– Creation of framework for quality improvement
– Transformation of work culture
– Customer and process focus
– Employee education and training
– Bench marking
– Recognition and reward
 ACCREDITATION

Laboratory accreditation is a procedure by

which an authoritative body gives formal
recognition of technical competence of
testing and or calibration for a laboratory
to carry out specific tests. This is based on
third party assessment against set
standards.
Why Laboratory Accreditation ?
The concept of Laboratory Accreditation was
developed to provide a means for third-party
certification of the competence of laboratories to
perform specific type(s) of testing and calibration.

Laboratory Accreditation provides formal recognition

of competent laboratories, thus providing a ready
means for customers to find reliable testing and
calibration services in order to meet their demands.
Laboratory Accreditation enhances
customer confidence in accepting testing /
calibration reports issued by accredited
laboratories.

The globalization of Indian economy and

the liberalization policies initiated by the
Government in reducing trade barriers and
providing greater thrust to exports makes
it imperative for Accredited Laboratories to
be at international level of competence.
 NABL
NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBERATION LABORATORIES
National Accreditation Board for Testing
and Calibration Laboratories (NABL) is an
autonomous body under the aegis of
Department of Science & Technology,
Government of India, and is registered
under the Societies Act.

NABL website is updated continuously with

respect to status of accredited laboratories
and their scope of accreditation.
Benefits of Accreditation
Increase of confidence in Testing / Calibration
data and personnel performing work.

Customers can search and identify the

laboratories accredited by NABL for their
specific requirements from the Directory of
Accredited Laboratories.

Users of accredited laboratories will enjoy

greater access for their products, in both
domestic and international markets, when
tested by accredited laboratories.
Potential increase in business due to enhanced
customer confidence and satisfaction.

Savings in terms of time and money due to

reduction or elimination of the need for re-
testing of products.

Better control of laboratory operations and

feedback to laboratories as to whether they
have sound Quality Assurance System and are
technically competent.
 Type

Small Laboratory
Receiving up to 100 patients/ day.

Medium Laboratory
Receiving up to 101-400 patients/ day.

Large Laboratory
Receiving above 400 patients/ day.
 Process of Accreditation
Stage I

– Prepare laboratory's application for NABL accreditation,

giving all desired information and enlisting the test(s)
along with range and measurement certainty for which
the laboratory has the competence to perform.

– Laboratory can apply either for all or part of their

testing.

– In case, the laboratory finds any clause (in part or full)

not applicable to the laboratory, it shall furnish the
reasons.
– Laboratories are required to submit 3 sets of duly filled in
application forms along with two sets of Quality Manual
and Application Fees.

– NABL Secretariat on receipt of application will issue

acknowledgement to the laboratory.

– After scrutiny of application for it being complete in all

respects, a unique Customer Registration Number will be
allocated to laboratory for further processing of application.

– NABL Secretariat shall then nominate a Lead Assessor for

giving Adequacy Report on the Quality Manual / Application
submitted by the laboratory.

– A copy of Adequacy Report by Lead Assessor will be

provided to Laboratory for taking necessary corrective
action, if any. The laboratory shall submit Corrective Action
Report.
Stage II

– NABL Secretariat shall organize the Pre-Assessment audit,

which shall normally be carried by Lead Assessor at the
laboratory site.

– The pre-assessment helps the laboratory to be better prepared

for the Final Assessment. It also helps the Lead Assessor to
assess the preparedness of the laboratory to undergo Final
Assessment.

– A copy of Pre-Assessment Report will be provided to Laboratory

for taking necessary corrective actions on the concerns raised
during audit, if any.

– The laboratory shall submit Corrective Action Report to NABL

Secretariat.

– After laboratory confirms the completion of corrective actions,

Final Assessment of the laboratory shall be organized by NABL.
Stage III

– NABL Secretariat shall organize the Final Assessment at

the laboratory site(s) for its compliance to NABL Criteria
and for that purpose appoint an assessment team.

– The Assessment Team shall comprise of a Lead Assessor

and other Technical Assessor(s) in the relevant fields
depending upon the scope to be assessed.

– Assessors shall raise the Non-Conformance(s), if any,

and provide it to the laboratory in prescribed format so
that it gets the opportunity to close as many Non-
Conformance(s) as they can before closing meeting of
the Assessment.

– The Lead Assessor will provide a copy of consolidated

report of the assessment to the laboratory and send the
original copy to NABL Secretariat.
Stage IV

– After satisfactory corrective action by the laboratory, the

Accreditation Committee examines the findings of the
Assessment Team and recommend additional corrective
action, if any, by the laboratory.

– Accreditation Committee determines whether the

recommendations in the assessment report is consistent with
NABL requirements as well as commensurate with the claims
made by the laboratory in its application.

– Laboratory shall have to take corrective action on any

concerns raised by the Accreditation Committee.

– Accreditation Committee shall make the appropriate

recommendations regarding accreditation of a laboratory to
NABL Secretariat.
Stage V

– Accreditation to a laboratory shall be valid for

a period of 2 years and NABL shall conduct
periodical Surveillance of the laboratory at
intervals of one year.

– Laboratory shall apply for Renewal of

accreditation to it at least 6 months before the
expiry of the validity of accreditation.
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