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--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, -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: