Laboratory introduction,different departments and their functions

1. CLINICAL RESEARCH
LABORATORY
Prepared by: Shahid Nawaz
Researcher
King Saud University

2. OUR MISSION
To provide high quality clinical laboratory services for
the researchers and scientists of KSU Hospital and
beyond; and to undertake research that is clinically
focused, ethically appropriate and fiscally responsible.

3. Table of Content
1. Introduction
2. Purpose
3. o expertise
4. Objective
5. Implementation
6. Consultant and Technical Staff
7. Section and Function of Laboratory
8. FINANCIAL ASPECTS
9. Future Training Programmed
10. Clinical Research Laboratory Flow chart
11. Request Form
Introduction

4. Clinical Research laboratory testing is an essential part of quality
health care. It provides Researcher with objective data needed
to achieve their goal. Our fully equipped clinical laboratory
allows researcher to prepare, evaluate and store samples from
various studies. The Clinical Research laboratory Users are
mainly medical doctors, research fellows, research associates,
scientific officers, research assistants, post graduate students
(Ph.D. and M.Phil.) and post doctoral research workers. This
multi-disciplinary research unit is such a set up to encourage
exchange of ideas and experiences from different clinical
experts. Moreover, this arrangement enables sharing of
expensive equipment; research facilities and supportive
service.
Our laboratory is under the management of a Ph.D. Qualified
researchers. This clinical laboratory provides specialized
assays for research purposes that generally are not available
from routine clinical laboratories.
PURPOSE
Current research testing provided by the “clinical labs” is
problematic:
i. Research testing can interfere with clinical
operations.
ii. Clinical labs do not offer customized services or
most "esoteric" research tests.

5. iii. No capability to perform special handling/storage or
customized reporting.
iv. Clinical lab charges are too high for many research
studies.
v. Consultation with laboratory faculty not routinely
available for research.
vi. Some physicians have mistakenly sent research testing to
the clinical labs without clearly designating that they
are research specimens, which can create considerable
compliance problems with respect to billing of research
services to clinical sources.
vii. Services/tests provided only for research purposes
(i.e. for the purpose of qualifying a study subject or
research only end point) will not be billed to any Patient.
Viii. Services/tests paid for by the study sponsor cannot be
billed to any insurer or to the participant.
ix. Research Laboratory is billed only for clinical trial
Costs permitted under the University Management.
OUR EXPERTISE O:
The scientists and technologists of the Clinical Laboratory for
Research have many years experience in the area of blood
collection, specimen caring, instruments handling data
processing, record keeping.
OBJECTIVES

6. The OBJECTIVES of the Research Laboratory is to serve
the Researcher/scientists from inside, or outside of the
Organization to the best standards attainable (i.e. Quality
Service) through:
• Provision of Consultation and Support to the
Researcher in order to achieve their goal.
• Provision of Genetic and General Health counseling and
awareness programs.
IMPLIMENTATION
Contact with different institute Researchers inside and outside the
University.
CONSULTANTS / SPECIALISTS /
TECHNICAL AND SUPPORT STAFF
The Laboratory Department consists of consultant
or senior specialist.
1. Dr.Assim alfadda
Telephone Number:
2. DR. Waheed
Telephone No:
Mobile No:

7. 3. Dr. Amr Mustafa
Telephone No:
Mobile No :
4. Shahid Nawaz
Researcher,KSU
Telephone No:
Mobile No :
TECHNICAL STAFF
Medical Laboratory Specialist and Medical Technologist with
B.Sc and M.Sc in general or specialized laboratory discipline.
SUPPORT STAFF
Equipment & Reagent's Officer
Telephone No:
Secretary
Telephone No:
Central Receptionist
Telephone No:
Receptionist
Telephone No:

8. FUNCTIONS OF THE LABORATORY
DEPARTMENT
The Laboratory Department provides state-of-the-art laboratory
testing in support of Researchers/Scientists in side and out side
the Research center.
Laboratory Sections
1-Clinical Chemistry
2- Nephlometry
3- Haematology
1- Clinical Chemistry SECTION
LIST OF Tests:
- Acid Phosphatase - Lipase
- Albumin - Lithium
- Alkaline Phosphatase - Magnesium
- Amylase - Phosphorus
- ALT / SGPT - Potassium
- AST / SGOT - Sodium
- Bicarbonate - TIBC
- Calcium - Total Bilirubin
- Cholesterol - Total Protein
- Cholinesterase - Triglyceride

9. - CK / CPK - Urea
- CK-MB - Uric Acid
- Creatinine - Direct Bilirubin
- Glucose - HDL-C
- Iron
- Lactate / Lactic Acid
- LDH (Lactate Dehydrogenase)
- LDL-C (Low Density Lipoprotein-Cholesterol)
- GGT (Gamma-Glutamyl / Transterase)
Interpretation of Blood Tests:
A few test interpretations is below
Cholesterol
Increased in late pregnancy, the neophrotic syndrome, hypothyroidism,
and most hyperlipoproteinaemias especially in familiar
hypercholesteolaemia , diabetes mellitus, primary biliary cirrhosis and
obstructive jaundice.
Decreased in hyperthyroidism, severe infection, severe anemia, protein-
calorie malnutrition, long-standing steatorrhea, subacute hepatic necrosis,
terminal portal cirrhosis, hypo-β-lipoproteinaemia and abeta-lipoproteinaemia.
Glucose (Blood)
• Hyperglycemia occurs in strenuous exercise, emotion, shock, infections,
presence of circulating insulin antibodies, phaechromocytoma,
postgastrectomy dumping syndrome, liver disease, and acute pancreatitis,
some cases of pancreatic cancer, diabetes mellitus, acromegaly,
Cushing's syndrome, thyrotoxicosis and severe burns.

10. • Blood glucose below 2.2 mmol/L may occur in underweight infants,
premature infants of diabetic mothers, healthy infants, prolonged
exercise, normal pregnancy, protein-calorie malnutrition, leucine
sensitivity, galactosaemia, hereditary fructose intolerance, glycogen
storage diseases, insulin over dosage, β-islet cell tumor, dumping
syndrome, liver disease, hypopituitarism, adrenocortical insufficiency,
ackee nut poisoning, amantia phalloides poisoning, acute alcoholism
and poisoning with Salicylate, Paracetamol, antihistamines, etc..
Triglycerides
Increased in normal pregnancy, obesity, von Gierke's disease,
diabetes mellitus, alcoholism, the nephrotic syndrome, uremia,
maintenance dialysis, hypothroidism, cholestasis, biliary cirrhosis,
paraproteinaemias, most hyperlipoproteinnaemias (especially
hyperchylomicronaemia). Transient increase in serum triglycerides
occurs in alcoholic fatty liver, cirrhosis, acute pancreatitis and
myocardial infarction.
Creatinine Kinase (CK / CPK)
• Increased in hypoxia, hypothermia, after severe exercise, multiple
injections, cardiac massage, in malignant hyperpyrexia, myxoedema,
cerebrovascular accidents, cerebral ischaemia, motor neuron disease,
and schizophrenia.
• Decreased in thyrotoxicosis.
Acid Phosphatase
• Increase prostatic acid phosphatase occurs in prostatic cancer,
prostatic infarction, and occasionally in benign prostatic hypertrophy.
Rectal examination increased the level of prostatic cancer and benign
prostatic hypertrophy.

11. • Increased non-prostatic acid phosphatase occurs in primary
hyperparathyroidism, myeloma, Paget's disease of bone, primary bone
tumors, metastases in bone and Gaucher's disease.
Alanine Aminotransferase (ALT, SGPT)
• Increased in liver disease, myocardial infarction (moderate increases)
and skeletal muscle disease.
Albumin
• Increased in haemoconcentration.
• Decreased in haemodilution, analbuminaemia, inadequate intake or
protein, malabsorption, severe liver disease, the nephrotic syndrome,
protein-losing enteropathies, severe haemorrhage, severe burns, after
severe injury, chronic infections and in malignancy.
Aldolase
• Increased in diseases of cardiac muscle, skeletal muscle and liver.
Alkaline Phosphatase
• Increased in cholestasis, rickets, osteromalacia, hyperparathyroidism,
Paget's disease of the bone, osteagenic sarcoma and bone
metastases. A transient, very marked increase (up to about 30 times
the upper limit of normal for adults) sometimes occurs in less than 3
years-old infants who have no biochemical or radiological evidence of
bone or liver disease.
• Decreased in severe anaemia, kwashiorkor, scurvy, cretinism,
achondroplasia and hypophosphatasaemia.
Protein
• Increased in haemoconcentration and the hyper gammaglobulinaemias.
• Decreased in haemodilution, low protein intake, severe liver
disease, the nephrotic syndrome and protein-losing enteropathies.

12. 2-NEPHLOMETRY SECTION
Specific Proteins & Serologies
Albumin
Alpha1-Acid Glycoprotein
Alpha1-Antitrypsin
Alpha1-Microglobulin
Alpha2-Macroglobulin
Beta-2-Microglobulin
Ceruloplasmin
Complement C3
Complement C4
Immunoglobulin A
Immunoglobulin E
Immunoglobulin G
Immunoglobulin M
Microalbumin
Prealbumin
Note: So many other research related test can be performed by this
instrument.
.
3-HAEMATOLOGY SECTION
26 Available Parameters
WBC RBC Plt
NE# Hgb MPV
NE% Hct Pct*
LY# MCV PDW*
LY% MCH
MO# MCHC
MO% RDW

13. EO# IMM%
EO% EO%
BA#
BA%
ATL#*
ATL%*
FINANCIAL ASPECTS:
1-INSTRUMENTS AND EQUIPMENT REQUIRMENT
A list of all items, we required to start new clinical Research
laboratory is as follow.
S.NO Equipment Manufacturer Distributor Quantity
1 Clinical Chemistry Analyzer 1
2 Nephlometer 1
3 Hematology Analyzer 1
4 Dis/Deionizer Water Sys. 1
5 Autoclave 1
6 Oven 1
7 - 33-80 C Freezer 4
8 34 -20 C Freezer 4
9 35.4 C Refrigerator 8
36.4 C Refrigerator with
built-in plug
2
10 Balance 0.1 mg 1
11 Flammable liquid cabinet 2
12 Balance 1
13 Balance 1
14 pH meters 4
15 Refrigerated centrifuge 3
16 Clinical Centrifuge 2
17 High Speed Centrifuge 1

14. 18 Micro Centrifuge 4
19 Hot plate and stirrer 4
20 Thermomixer 2
21 Heating Block 4
22 Water Bath 2
23 Shaking water Bath 2
24 Orbital shaker 2
25 Vortex mixer 6
26 Automatic pipette(set of 4) 8
27 Multichannel pipette 4
28 Body Fat analyzer 1
29 Shaking incubator for
culture
1
30 Glass ware washing system
31 Pipette filler 06
2- BUILDING:
S.NO Description Charges/Per
Month
Total
1 Building Rent
2 Electric
3 Telephone
4 Internet
5 Building
Maintenance
6 Water
7 Furniture
3- WORKING CAPITAL:
S.NO Description Quantity Salary/Mo Total

15. Expenses
1 Senior Teaching
Staff
2 Junior Technical
Staff
3 Supporting Staff

16. LIST OF CONSUMBLES
1- Clinical Chemistry SECTION
Calibrators: Formula = 200 SR x 6month =33.3/M
= 3.33SR/day, if we run 10 sample/day
= 0.33/Test
S.NO ITEM COMPANY PACKING
SIZE
COST
Approximate
COST/ Test
01 Calibrator (1x6)2mL 200(33.3X6) 0.33
02 Control 1x2 150(25x6) 0.083
03 Cuvettes 1x6
04 Sample Cup 1000 /pk 200 0.20
05 Blue Tips 500/pk 30 SR 0.06
06 Yellow Tips 500/pk 30 SR 0.06
07 Plastic Pipettes 1000/pk 50 SR 0.05
08 Syringe 1x100 35 0.35
09 Alcohol Swab 1x100 15 0.15
Bandage 1x100 15 0.15
11 Blood sample tube 1x100 50 2.0
12 Plastic tube(For serum
or Plasma )
1x1000 200 0.20

17. COST OF TESTS
VITROS 350 CLINICAL CHEMISTRY ANALYZER

18. KIT PRICE PACKING
SIZE
Calibration
One time
/week
Control
Daily
Total
Calibration
+
Control
Other
Consumab
les
Cost/Test
(S.R)
ALT 250 300T 8X4=32 30X2=
60
300-
92=208
3.50 0.83+3.50
=4.33
Amylase 90.0 60 8X1=8 2X4=8 90-
16=74
3.50 0.82+3.50
=4.32
Magnesium 90.0 60 8X1=8 2X4=8 90-
16=74
3.50 0.82+3.50
=4.32
Bilirubin 300 300T 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
Calcium 300 300T 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
Phosphorus 300 300T 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
ACP 90 60T 8X1=8 2X4=8 90-
16=74
3.50 0.82+3.50
=4.32
Potassium 250 300 8X4=32 30X2=
60
300-
92=208
3.50 0.83+3.50
=4.33
Chloride 250 300 8X4=32 30X2=
60
300-
92=208
3.50 0.83+3.50
=4.33
Chol 300 300 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
Sodium 250 300 8X4=32 30X2=
60
300-
92=208
3.50 0.83+3.50
=4.33
Creatinine 300 300 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
CK 90 60 8X1=8 2X4=8 90-
16=74
3.50 0.82+3.50
=4.32
T.Protein 250 300 8X4=32 30X2=
60
300-
92=208
3.50 0.83+3.50
=4.33
Triglyceride 300 300 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
= 2.90
GGT 250 300 8X4=32 30X2=
60
300-
92=208
3.50 0.83+3.50
=4.33
Urea/BUN 300 300 8X4=32 30X2=
60
300-
92=208
3.50 0.69+3.50
Albumin 90.0 60 8X1=8 2X4=8
90-
16=74
90-
16=74
3.50 0.82+3.50
=4.32

19. HAEMATOLOGY SECTION
COST OF TEST
CELL DYNE EMERALD

20. HAEMATOLOGY ANALYSER
FUTURE TRAINING PROGRAMME
DESCRITPTION UNIT ENOUGH FOR PRICE Test Run on
Instrument for
06 Mon
COST /TEST
LYSE 960 mL 2050 TESTS 3000
DILUENT 10 L 650 TESTS 800
CLEANER 960 mL 300 TESTS 600
CALIBRATOR 2X2.5 mL 6 Month 800
CONTROL 6X2.5 mL 6 Month 800
------ -------- -------- 600 Tests
(including
Calibrator+
control)
----- ------- -------- ------- 10 SR/Test
TOTAL CAST 6000 SR

21. We have planned in future to start laboratory training for our Medical
students and Medical Technicians in our Laboratory
• To start a carrier with a passion for both medicine and research.
• Opportunity for an integrative career as a clinician and a scientist
-Direct patient care
-Clinical research
-Basic research with an understanding of human disease.
CLINICAL RESEARCH LABORATORY
MODEL
Specimens to lab:
Custom Clinical Requisition
MRN or Unique Study –ID From Lab.
(study IDs Coded by CRL)
Custom
Clinical lab
Meet with laboratory to initiate
study: Support for method
selection
-Selection of safety relevant
tests and EMR transmission
•Customized requisitions
•customized reports

22. User Case
Requisitions Form: Custom
Lab Use
Only
King Saud University
Obesity Research Center
Requisition Form
Date :
Location:
Ordering the samples
by
Lab Support services
Custom reporting
-Indivisual forms
-Monthly summary
-Electronic files

23. Fund Number: Telephone No:
Principle
Investigator:
Provider: Patient Identification area: MRN,
Full Name; Gender, DOB
MRN:
Name:
Date of Birth:
Sex :
Study ID:
Date collected: Time Collected:
Contact Telephone
No#
Diagnosis Code:
Specimen Type: Blood Serum Plasma Urine Culture Medium
Buffy Coat Fluid Other _______________
Number of Specimens in bag _____________ sampling sheet
attached
Study Questions
IRB# Consented:
Visit : Subject ID: