Final Year Project

“Establish a model of fully functional Diagnostic Lab”

BS MLT Evening (2020-2024)

Department of AHP

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 Alpha Diagnostic Lab
Diagnosing today, for a healthier tomorrow

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Participants of Project αlpha:

• Ahtasham Ahmad (8410)

• Hafsa Gul (8420)
• Muhammad Adeel (8426)
• Ali Hassan (8428)
• H.M. Abu Bakar (8430)
• Aliza Aziz (8444)
• Hira (8460)

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Introduction:
The word Alpha, in the name Alpha diagnostic lab denotes the first in a series, the
brightest star, dominant in its field and even the term first class is coined as alpha.
Alpha diagnostic lab is the initial step towards a greater goal in the diagnostic field.

Our aim:
Our aim is to prioritize the health of our customers by creating an environment of trust,
quality and reliability.

Objective:
• Laboratory services influence the efficiency and effectiveness of both clinical and public
health functions, including diagnosis, treatment, health promotion, disease prevention –
WHO
• Laboratory services are essential to guide decision-making processes by clinicians, public
health specialists, and health policy makers – WHO
• Laboratory services, operating according to international principles of quality and safety,
are an essential part of strong health systems and are crucial to improving health care.
The analyses that laboratories provide offer a reliable foundation for evidence-based
control of disease – NIH

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 Location:
DHQ New Gate from Tehsil Rd, Okara, Punjab 56300, Pakistan
https://maps.app.goo.gl/28kd4ASjHLCvesk6A

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Why?
According to official data of DHQ Okara hospital, in 2022, the numbers of registered
outdoor patients in DHQ hospital Okara were 2500 per day. Which was expected to increase by
40% in the next two years (upto year 2024). New Lab setups were unable to emerge due to lack
of professional medical study centers in the region. The setups already established were offering
basic level of diagnostic lab profiles while especial tests were offered via affiliation with other
diagnostic labs in other major cities i.e. Lahore and Faisalabad

PHC registration:
The PHC Directorate of Clinical Governance and Organizational Standards is responsible
for developing standards for all types of Healthcare Establishments (HCEs). The level of
standards ranges from minimum to that of accreditation, keeping in view the local context and
the ground realities.

Lab Structure:
Depending upon the services provided and expected patient load, Safe lab structure is designed
in accordance with Lab technologist/technician,
health administrative, architect and Civil engineer.
Whole inventory is listed to the investors for finance
support.

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 • Reception and waiting Area
• Phlebotomy Section & other sample Collection
• Lab Sections
• Routine Biochemistry
• Special Biochemistry
• Hematology
• Routine Microbiology
• Pathologist Room
• Manager’s Room
• Staff Room
• Inventory and Store room
• Wash rooms
• Power Room

The procedures for establishing basic requirement for laboratory facilities are determined after
considering the following points.
1. The amount work to be performed
2. The type and number of technical units (e.g. Serology, hematology)
3. The number of personnel that will be working in each unit
4. The equipment and furniture required in each unit
5. The auxiliary areas needed: a. Administration, reception b. technical washing,
sterilization, reagent and media preparation, storage.
6. Utility Services and Distribution

The Laboratory Environment- Facilities:

All laboratories need at least a building, power supply, and water supply that suits their
activities. Most often, laboratories are hampered in their operation because of limited space
or inefficient use of the space available. This is because insufficient attention has been given

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 to the design and planning of the laboratory. The first and most essential part in planning a
health laboratory is for those involved, i.e. the laboratory personnel, health officials and
administrators, and the architect, to have a clear idea of laboratory requirements.
The laboratory technician plays a leading role in the planning and design of laboratory
facilities. Therefore, he/she must have full knowledge of the needs of a clinical laboratory,
particularly: - The geographical area where it will serve best - The space and equipment
required the lab technician should workout this in collaboration with the health administrator
and the architect, to prepare a functional program giving details on the size and the general
characteristics of the laboratory to be designed, taking budgetary considerations into account.
This functional program will consist of a detailed description (qualitative and quantitative) of
the activities of each unit and thus determine the space and equipment required. It should also
give full information about the operation of the laboratory so that the architect may design
the layout more efficiently.

• Walls
• Permanent Walls
• Partitions can be temporary
• Ceiling
• Easily disinfected
• Sealing
• Height 8.5-9.5 feet
• Doors
• Easily disinfect
• At least 3 feet wide (split in half)
• Floor
• resistant to acids, alkali and salts
• Windows
• 90 cm above floor
• Cupboards and Shelves
• Rooms
• - Main working room (minimum 12x15 feet): for specimen
• collection, processing and examination.
• - Washing room (minimum 6x6 feet): for cleaning all
• laboratory ware and disposal of excreta.
• - Store room (minimum 6x6 feet):
• for safe storage of stocks of reagents and consumables, and equipment that is
not in use.
• Sinks and Basins
• chemical resistant material, e.g. ceramic
pg. 8 • Furniture
• Bench: 0.9 meter high and 0.5 meter wide
Services Offered:
I. Complete Blood Count (CBC)
II. Hemoglobin Level (Hb, HBA1C) & Hematocrit (HCT)
III. Coagulation Tests (PT, APTT, D-dimer)

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 IV. Blood Typing (ABO, Rh)
V. Erythrocyte Sedimentation rate (ESR)
VI. Blood Parasite Examination (Malarial PF)
VII. ELISA
VIII. Screening (HBsAg, HCV, HIV, Malaria, Syphilis, MTB)
IX. Basic Metabolites Panel (Na+, K+, Cl, Bicarbonates, Ca2+)
X. Liver Function Tests (ALT, AST, ALP, Bilirubin)
XI. Kidney Function Tests (Creatinine, Urea, BUN) and Uric Acid
XII. Lipid Profile (Cholesterol, LDL, HDL, TG)
XIII. Serum Protein level
XIV. Urinalysis
XV. Fecal analysis
XVI. Collection Center for (Molecular Biology, Culture)

Major Equipment’s in respective analytic sections:

1. Hematology:

a. Sysmex XP 300
b. Swelab Alfa plus
c. HBA1C analyzer by EosCare
d. ABO typing Diagas
e. Glass Slides

2. Biochemistry:

a. CL-900i - by Mindray
b. Humastar 300 SR - Human Diagnostics
c. Microlab 300 by Elitech and Diasys Reaagents
d. Easylyte Electrlyte analyzer by Medica
e. PT/APTT Weiner Lab
f. Screening POCT/ICT kits
g. Incubator
h. DLab Centrifuge

3. Microbiology:

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 a. Microscope CX23 by Olympus
b. ZN and Giemsa Stain
c. Glass Slides and cover slips

Equipments and Inventory

Equipments Price Quantity Price of equipments
Sysmex XP 300 1000000 1 1000000
Swelab Alpha Plus 400000 1 400000
Olympus CX23 400000 1 400000
Eoscare HBA1C analyzer 300000 1 300000
Easylyte Electrolyte 300000 1 300000
Analyzer
Fridge/Refrigerator 100000 1 100000
CL-900i 210000 1 210000
Humastar 300SR 300000 1 300000
Vortex Mixer 10000 1 10000
Incubator 75000 1 75000
Erba PT/APTT analyzer 300000 1 300000
DLab Centrifuge D0506 45000 2 90000
Equipments Price Quantity Price of equipments
Micro Pipette 1000mL 2500 3 7500
Micro Pipette 100mL 2500 3 7500
Micro Pipette 10mL 1500 3 4500
Pipette Stand 3000 3 9000
ESR stand 3500 1 3500
Sample Racks 200 1 200
CBC Vials 10 300 3000
Clot Vials 8 300 2400
NaF Vials 12 300 3600
Blood Culture Bottles 250 10 2500
ESR Vials 20 50 1000
Room thermometer 1500 4 6000
Digital thermometers 450 5 2250
HCV ICT kits 45 300 13500
HBsAg ICT kits 55 300 16500
HIV ICT 47 300 14100
Syphilis ICT 50 100 5000
Dengue ICT 54 100 5400
Malaria ICT 59 150 8850

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 Gloves Box 450 4 1800
Face Mask Box 300 3 900
Refrigirator 80000 5 400000
Stool for H. Pylori devices 65 100 6500
UPT ICT 10 200 2000
Sample Save cups pack 300 5 1500
Trop I ICT 90 60 5400
CRP Kit 2000 1 2000
RA factor Kit 2200 1 2200
Blood Typing Kit 3500 3 10500
Chemistry Reagents 250000 1 250000
Hematology Reagents 100000 1 100000
Stains 1000 1 1000
Electrolyte Reagent 30000 1 30000
PT/APTT reagent 30000 1 30000
Yellow Tip pack 200 3 600
Blue Tip 200 5 1000
Syringes Box 700 20 14000
Tourniquets 150 2 300
Equipments Price Quantity Price of equipments
Slides 150 5 750
Slide Rack 900 3 2700
Cover Slips 160 5 800
Waterbath 20000 2 40000
Glassware and Plastic Ware 15000 1 15000
Cotton/banadges 600 10 6000
Neubauer Chamber 4500 3 13500
First Aid Kits 3500 6 21000
Spill Kits 15000 3 45000
Senitizers 6500 1 6500
Normal Saline/Deionized 110 10 1100
Water
Disinfectant 20500 4 82000
office Chairs 8000 3 24000
Chairs 4000 17 68000
Sofa 30000 3 90000
Stools 3000 8 24000
LED bulbs 30 200 6000
Ceiling Fans 8000 5 40000
Wall fans 4500 5 22500
AC 150000 7 1050000

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 Tables 5000 5 25000
Computers 10000 6 60000
Printers 45000 2 90000
LCDs 5000 5 25000
Wall LCD 55000 1 55000
Wall Clocks 1500 1 1500
Cabinets 25000 4 100000
Metal cabinets 40000 5 200000
Wash Bason 6000 7 42000
Shelves 150000 5 750000
Cabin Under Shelves 60000 5 300000
UPS 15 KVA 45000 1 45000
Batteries 30000 5 150000
Fire Extinguishers 4000 7 28000
Switch boards 1500 20 30000
Biohazard Symbols 1 0
Chlorine Treatment 1 0
PHC registration 110000 1 110000
Equipments Price Quantity Price of equipments
Cameras 70000 1 70000
Power consumption 200000 1 200000
Waste bin (Unit of 3) 15000 6 90000

Budget: 12.5M
Direct Cost: 9M
Indirect costs: 2M
Other Costs: 1.5M
Cash In Hand: 2.5M

Standard Operating Procedures (SOPs) in a medical laboratory are written instructions

that outline the step-by-step processes and protocols to be followed in various aspects of
laboratory operations, ensuring consistent and standardized practices for quality control and
patient safety.
SOPs cover areas such as specimen collection, laboratory safety, test request and reporting,
equipment management, staff training, and incident reporting. They promote accuracy,
regulatory compliance, and operational efficiency within the laboratory.

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 Medical Lab:
1) Specimen Collection and Handling:
a. Clearly define the procedures for collecting different types of specimens.
b. Provide guidelines on appropriate containers, transport media, and labeling
requirements.
c. Describe the necessary precautions for handling potentially infectious specimens.
d. Outline the process for ensuring proper specimen identification and tracking.

2) Laboratory Safety:
a. Specify safety guidelines for handling hazardous chemicals, biological materials, and
equipment.
b. Provide instructions for the proper use of personal protective equipment (PPE) such
as gloves, lab coats, and masks.
c. Define procedures for waste disposal, including biohazardous waste segregation and
disposal protocols.
d. Detail emergency response plans and evacuation procedures.

3) Quality Control and Assurance:

a. Outline procedures for instrument calibration, maintenance, and performance
verification.
b. Specify guidelines for internal quality control (IQC) and external quality assessment
(EQA) programs.
c. Describe the process for documenting and addressing non-conforming results or
equipment failures.
d. Provide guidelines for proficiency testing and staff competency assessment.

4) Test Request and Reporting:

a. Define the process for accepting test requests, including required patient information.
b. Specify the turnaround time expectations for different types of tests.
c. Outline the procedure for result verification, including the use of double-checking or
second-reader protocols.
d. Describe the reporting format and guidelines for result interpretation.

5) Laboratory Information Management:

a. Establish procedures for maintaining accurate and complete patient records.
b. Define guidelines for data entry, including proper coding and nomenclature usage.

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 c. Describe the process for result reporting and result retrieval.
d. Outline the security measures and data backup protocols to ensure confidentiality and
data integrity.

6) Equipment and Reagent Management:

a. Establish guidelines for the receipt, storage, and inventory management of laboratory
equipment. b. Define procedures for the storage, handling, and disposal of laboratory
reagents and consumables.
b. Specify the process for equipment qualification, including installation, operational,
and performance qualification.
c. Detail the protocol for tracking and documenting equipment maintenance and repairs.

7) Staff Training and Competency:

a. Define the process for initial and ongoing staff training, including safety, SOPs, and
test-specific protocols.
b. Outline the requirements for maintaining staff competency records.
c. Specify procedures for documenting staff training and updating training materials.
d. Detail the process for handling staff shortages or temporary replacements.

8) Change Control and Document Management:

a. Establish procedures for managing changes to SOPs, including review, approval, and
version control.
b. Define the process for communicating and implementing changes to laboratory staff.
c. Specify guidelines for archiving and retaining records of previous versions of SOPs
and related documents.
d. Detail the procedure for periodic review and revision of SOPs to ensure their
accuracy and relevance.

9) Incident Reporting and Investigation:

a. Define the process for reporting and documenting laboratory incidents, errors, and
near misses.
b. Specify guidelines for investigating incidents, including root cause analysis and
corrective actions. c. Establish procedures for communicating incident findings and
implementing preventive measures. d. Detail the process for tracking and trending
incidents to identify potential areas for improvement.

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 10) External Stakeholder Interaction:
a. Establish guidelines for communicating with healthcare providers, patients, and
external laboratories.
b. Define the process for addressing inquiries, complaints, and requests for additional
information.
c. Specify procedures for collaborating with external stakeholders on research projects
or quality improvement initiatives.
d. Detail the protocol for participating in external proficiency testing programs or
regulatory inspections

Lab Waste Management:

Chemical waste management is a critical aspect of laboratory operations. Proper
handling, storage, and disposal of chemical waste are essential to ensure the safety of
laboratory personnel, protect the environment, and maintain regulatory compliance.
The overriding principle governing the prudent handling of laboratory waste is that no
activity should begin unless a plan for the disposal of nonhazardous and hazardous
waste has been formulated. Application of this simple principle ensures that the
numerous state and federal regulatory requirements for waste handling are met and
avoids unexpected difficulties, such as the generation of a form of waste (e.g., chemical,
radioactive, biological) that the institution is not prepared to deal with.

There are four tiers to waste management to reduce its environmental impact:
 pollution prevention and source reduction;
 reuse or redistribution of unwanted, surplus materials
 treatment, reclamation, and recycling of materials within the waste
 disposal through incineration, treatment, or land burial

There are various private and public waste management authorities in district including

• Green Planet Management system

• ARAR Medical Waste Management

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 Flow of Work

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