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New Pathology Lab setup-

Part 1
Presented By : Dr. Sagar N. Hingrajia.
Under guidance of : Dr. Neeru Dave.
Dr. Alpesh Chavda.
Introduction.
Setup of a new Pathology Lab is
complex process which requires
proper planning, study of market,
location, capital investments,
infrastructure, equipments and
qualified trained staff.

Role of Pathologist is central and


most crucial in setup of new
Pathology lab.
Planning,
Capital
investments.

Identification
Direction and
of target
future
population
progress
and demand

Pathologist

Marketing Infrastructure
and Public and
relations. Equipments

Staff
management
 First and most important step in establishment of Lab is
planning.
 Planning must include following points
 Knowing the target population and demands.
 Scope and type of lab
 Capital investment
 Location
 Lab can be independent or franchisee of well established lab.
 There can be single owner or partnership with other Pathologist.
Estimated Capital Investment required
 Depends on type of lab and scope of lab.
 It is wise to gradually increase the investments.
 Can start with minimum 15 – 20 lacs (all basic
hematology, clinical pathology and clinical
biochemistry tests).
 Establishment can be done in rented place or
owned place.
 Investment should be done keeping in mind
the worthiness of profit.
 Self money, bank loan, investors, IPO
Types of Pathology Labs
 According to NABL
 Small : up to 100 patients per day
 Medium : up to 101 – 400 patients per day
 Large : above 400 patients per day.

 According to ownership
 Government
 Private
 Quasi Government (Trust run labs)
Types of Pathology Labs
 According to lab services
 Clinical pathology
 Hematology
 Histopathology
 Cytopathology
 Clinical biochemistry
 Microbiology and Serology
 Genetics

 According to location
 Hospital Attached
 Stand alone
Steps involved in starting a diagnostics
center in India are as follows:-

Business Registration – You have to register your


business to get a legal entity in the form of
private limited company, proprietorship or as a
partnership company.
Get required license
Hire qualified technicians
Setup lab infrastructure
Setup lab equipments
License required to start a diagnostic center

Get registered with Shops and Establishments


Act 2019
Get registered with Clinical Establishment
Act(not implemented in Gujarat yet)
Get registered with biomedical waste disposal
body
Get NOC from fire department
Get NOC from municipality
Accreditations for Medical Laboratory

 Not mandatory in India but highly recommended.


 Test results from clinical laboratories must ensure
accuracy, as these are crucial in several areas of health
care. It is necessary that the laboratory implements
quality assurance to achieve this goal. The
implementation of quality should be audited by
independent bodies, referred to as accreditation
bodies.
 Accreditation from National Accreditation Board for
Testing and Calibration Laboratories (NABL) based on
ISO:15189, 2012 standards.
Staff Management
Staff Management
 The staff selected to work in the lab should meet the set
standard qualifications for respective designations.
 Qualification norms for technical staff according to NABL
 The technical person performing the tests should have one of
the following qualifications:
 Graduate in Medical Laboratory Technology
 Diploma in Medical Laboratory Technology with the course of at
least two years duration
 Diploma/ certificate in Medical Laboratory Technology with the
course of at least one year duration and two years of
experience in a medical laboratory
 The lab technicians should have a thorough control and
knowledge over the machines used in the lab.

 They should be provided with training and induction


during the initial stages of their appointment.

 This is basically to reduce the errors they make and to


make them adapt to the methods of the lab.

 They must work in lab for fixed number of hours per


week.

 Immunization with Hep B vaccine is mandatory.


Requirement of Staff
 Signing Authority – MD/DNB/DCP Pathologist (With MCI
registration)
 Receptionist
 Phlebotomist
 Laboratory Technician
 Laboratory Technical Assistant
 Cleaner/Sweeper
 Number of Staff depends upon the working hours and
work load of individual lab
Basic infrastructure for New Pathology
Lab setup
 Sufficient Area
 Electricity supply with Stabilizers and Power Backup
 Water supply
 Working desks and furniture
 Air conditioners and exhaust fans
 Refrigerators
 Computers with Printer and Internet
Space of Lab
 Minimum space requirement should be to fit work of
hundred patients per day. 22×25 feet
 Maximum attention should be given for space so that
the related factor infrastructure also turns out to be an
efficient one.
 Space planning is necessary to place things right at its
place.
 Clubbing of two three departments performing various
activities should not happen since they may result in
undesirable condition.
Compartments in Lab
 Reception area
 Waiting/sitting area
 Blood collection chair
 Laboratory area/ Processing rooms
 Reporting room
 Toilet
 Wash Areas
 Waste discard areas
 Store room
All areas should preferably have sign boards
Equipments and consumables
 Selection of equipments and consumables is very
important.
 It depends upon the decided scope of lab.
 All equipments in lab require maintenance and
calibration time to time depending upon work load of
lab.
 Quality control whether internal or external must be
done timely.
 Preparation of SOP and WDI for each test is
recommended for quality assurance.
Points to be considered before
purchase of lab equipment are
 Number of manufacturers available in market
 Comparison of their instruments
 Work load of lab
 Technical specifications, features of instrument and requirement
of lab.
 Reviews by other senior Pathologist using that machines
 Price of the instrument
 Per test cost
 After sale service provided by manufacturer(AMC/CMC)
Points to be considered before purchase of
consumables/ reagents are

Number of manufacturers available in market.


Comparison of other reagents.
Cost per test.
Validity and Expiry date of reagents.
Storage conditions.
Reviews from senior Pathologist using that reagent.
Quality controls, Standard and calibrator provided by
Manufacturer.
Test and EQAS results.
Purchase of equipments and
consumables
 Local vendor.
 Representatives of manufacturers.
 New : online market
 labbazaar.com
 medicomart.com
 medikabazaar.com
 biomall.in

 Advantage : easy, comparison, buy and sell used


equipments.
 Disadvantages : reliability and after sale services.
Store management
 Storage of consumables must be done in proper separate
compartments.
 Storage should be done according to manufacturer’s advice
 Place must be dry, cool and away from direct sunlight.
 Inflammables must be stored separately in isolated cool place.
 Proper labelling on the reagents and chemicals should be there
 Content
 Mfg date
 Date of opening
 Expiry date
 Storage temperature and conditions.

 Stock records must be maintained.


 Order must be placed well in advance to avoid interruption in test.
Work environment safety
 Knowledge of hazards in pathology lab is must.
 Responsibility of manager.
 Hazards from chemicals, blood samples,
micro organisms, fire, explosion, electric shock etc.
 Control :
 Personal protective equipments
 First aid
 Eye wash station
 Fire extinguisher
 Spillage kit
 Emergency exit plans
 Training of staff
 Post exposure prophylaxis
Biomedical waste management
 Registration with biomedical waste management agency.
 Training of staff.
 Separate place for waste disposal.
Requisition form
 Should contain
 Patients details
 Name of referring doctor
 Brief clinical history
 Provisional diagnosis
 Type of specimen
 Date and time of collection of specimen
 Investigation requested
 Details of other related investigations done
 Requisition forms should be provided to all referring
consultants well in advance
Quality Assurance in Pathology lab

 Pre-examination processes
 The laboratory shall have documented procedures for the proper
collection and handling of primary samples. Developed and
documented criteria for acceptance or rejection of samples are
applied.
 Examination processes
 Selection, verification, and validation of the examination procedures.
Devise a system that can constantly monitor the traceability of the
sample.
 Post-examination processes
 Storage, retention, and disposal of clinical samples.
Quality Assurance in Pathology lab
 Release of results.
 When examination results fall within established alert or critical intervals, immediately notify
the physicians.
 The report should always contain
 Correct patients details
 Name of Primary or referring consultant
 Brief clinical history
 Name of test
 Result of test
 Reference range
 Interpretation of test
 Advice other investigations if necessary
 Name of method used for test
 Name of equipment used for test
 Sign of Pathologist with date and time.

 You can always communicate about clinical history of patient with the primary physician
whenever need arises.
Quality control in Pathology lab

Quality
control

Internal External
Quality Quality
Control Assurance
IQC EQA

Results Known Unknown

Results available Immediately Later when report is


received

Frequency Daily Periodically

Comparison Your lab only Your lab with other labs


using same methods.
Laboratory information system (LIS)

 A laboratory information system (LIS) is a software system


that records, manages, and stores data for clinical
laboratories.
 A LIS helps in sending laboratory test orders to lab
instruments, tracking those orders, and then recording
the results, typically to a searchable database.
Laboratory information system (LIS)
Laboratory information system (LIS)

 Advantages
Reduces human errors
Live tracking of sample and tests
Patients Data management and storage
Enables data exchange
Paper less records
Reduces turn around time
Billing records
Telepathology
 Telepathology in India is still in the evolving stages.
 Requires virtual slide scanner machine.
 Uses
 Telelearning or distance learning
 In remote diagnosis EQAS.
 Teleconsultation in India is done with glass slide and static
telepathology images.
 Websites such as telepathology.org.in have been very
successful in popularizing telepathology through quizzes
of interesting and rare cases.
Telepathology
Income/Expense records and Taxation

 Register PAN for business.


 Yearly income tax.
 Maintain daily income and expense sheet either in Excel or Register
or business management software.
 GST is not applicable to health care.
References :

 www.pubmed.gov
 NABL112
 www.mjpath.org.my
The most important point is to recognize the
needs of the client and be aware that
pathological diagnoses are always "the
final diagnoses".

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