Introduction to Medical Laboratory Technology

1. Introduction to Medical Laboratory Technology Dr Bipin Patel

2. What is Laboratory?

3. Case Scenario 1 • A 77-year old man presents to the emergency department with fevers and chills. • He has had multiple urinary tract infections in the past and feels that this is “another one”. • He has a history of diabetes mellitus, type 2 with diabetic nephropathy and chronic kidney disease.

4. Case Scenario 1 • Physical exam is notable for an ill-appearing man with right flank tenderness. • How will the medical laboratory impact this patient’s care?

5. Case Scenario 1 • Confirm clinical diagnosis • Urinalysis • Guide appropriate dosing of antibiotics • Dose adjustment for reduced GFR based on variables including serum creatinine • Guide selection of appropriate antibiotic therapy • With multiple course of treatment in the past there may be issues with antibiotic resistance

6. What is lab activities? • Today’s clinical laboratory is a complex arena offering an expansive menu of tests which continues to grow. • Hundreds of millions of laboratory tests are performed every year in India.

7. Role of Lab in Healthcare system? • Total Health Expenditure (THE) for india is estimated at Rs. 4,83,259 crores (3.89% of GDP and Rs. 3,826 per capita) for the year 2014-15 of which Laboratory and imaging services expenditure is Rs. 21,058 crores (4.7% of THE or 0.16% of GDP).

8. Role of Lab in Healthcare system? • It is noted in the literature that >70% of the objective data in a patient’s medical record comes from the clinical laboratory.

9. WHAT is “Laboratory Medicine”? • Laboratory medicine (clinical pathology) is the medical discipline that specializes in the performance, reporting and interpretation of clinical laboratory testsin the provision of high quality patient care.

10. WHO is “Laboratory Medicine” • Comprised of • Laboratory physicians which includes pathologists, biochemist, microbiologist, histo-pathologist, cyto-pathologist, hemato-pathologist, immuno-hematologist, molecular biologist, nuclear medicine expert in in-vitro diagnostics etc… • Laboratory scientists, technologists, and technicians, • Laboratory quality officers including quality manager, • Laboratory assistants, Laboratory attendants, • Laboratory equipment engineers etc…

11. WHO is “Laboratory Medicine” • The laboratory medicine workforce has a vital role in the health care system managing and applying evidence-based, scientific testing techniques to support patient care.

12. WHO is “Laboratory Medicine” • Each lab may have • one or more laboratory director(s) / Lab in-charge(s) / Head of Pathology(ies) / Head of Department(s) and • one or more technical manager(s) /specialist (s) responsible for testing services and • One quality manager of the lab • Some labs require a combined leadership group of 2-3 directors and multiple technical specialists

13. Types of Technical Areas/ Sections in Lab

14. Listed below is a partial list of types of technical areas/ labs • Hematology and Coagulation • Immuno-hematology/ Blood Bank Laboratory • Urinalysis, Fluid Analysis and Medical Microscopy • Chemistry/Immunoassay, & Endocrinology • Immunoserology • Microbiology (including Bacteriology, Virology, Parasitology, etc.)

15. Listed below is a partial list of types of individual clinical laboratories • Histopathology/ Anatomical Pathology & IHC • Cytopathology • Molecular Pathology • Cytogenetics • Tissue Typing/HLA • Toxicology

16. Types of laboratories

17. Types of Laboratory Business Models • Based on Ownership • Government Laboratories • For General Public • Established as reference labs like national institute of virology etc… • Established as part of legal frame work • NGO’s Laboratories • Charitable Trust owned labs • Registered Society owned Laboratories • Under Section 25 A registered company owned lab • Private Laboratories • Individual (Proprietorship) owned laboratories • Partnership firm owned labs • Owned by Company registered under company act.

18. Types of Laboratory Business Models • Based on location/ organizational structure • Stand alone lab • Hospital Based Lab • Part of Chain Lab • Part of CRO

19. Types of Laboratory Business Models • Based on expertise • Basic Composite Lab (Routine tests) • Routine Biochemistry tests like • Blood Sugar, Renal Function Tests, Liver Function Tests, Amylase, Lipase, Lipid profile, Cerebro -Spinal Fluid (CSF) and other biological fluids (glucose and protein), Oral Glucose Tolerance Test, Electrolytes, Calcium or Phosphate, HbA1c, any bio chemistry based rapid test. • Routine Hematology tests like • Haemogram, Bleeding Time, Clotting Time, Prothrombin Time, Activated Partial Thromboplastin Time, Blood grouping and matching. • Routine Microbiology tests like • Basic tests like Rapid Test (Point of Care tests) for infection, urine routine examination and microscopy, Hanging drop for Vibriocholerae, Stool for ova , cyst.

20. Types of Laboratory Business Models • Based on expertise • Medium Level labs (Specialized tests as defined in clinical establishment act) • Biochemistry tests like Hormone Bioassay, Tumor markers, plasma protein electrophoresis • Hematology tests like Coagulation Assay • Cytopathologytests like PAP smear, Fine Needle Aspiration Cytology(FNAC), sputum and CSF cytology • Microbiology tests like (a)Serological tests for viruses, bacteria, fungi, parasites (b)Cultural Sensitivity tests: Bacterial or fungal (c)Other special stains besides Gram's stain.

21. Types of Laboratory Business Models • Based on expertise • Advanced Lab • Biochemistry tests like • Coagulation profile, Drug monitoring and toxicology assay, • Molecular genetics, tests for detection of inborn errors of metabolism • All other Haematology tests also. • Histopathology Examination, Immunohisto-chemistry, • Molecular genetics • Cytopathology tests like ImmunoCytochemistry. Other biological fluid cytology; Ultrasound or CT guided FNAC. • Microbiology tests like • Culture sensitivity tests for viruses. • Real Time Polymerase Chain Reaction (RTPCR) tests. • Tissue diagnosis test for infectious diseases.

22. Who governs Laboratory? • State laws govern laboratory services in India. • National laws are providing guidance to create state laws. • In Gujarat, Clinical Establishment Act passed by Gujarat Assembly regulates laboratory services.

23. Who governs Laboratory? • Other laws like Indian Medical Act, and • National Health Mission, • Ministry of Health & Family welfare and health education also contributes in regulating laboratory practices in Gujarat & India

24. Additional Terms

25. “Reference lab” • In our medical center the lab tests performed at reference labs are often called “send out labs” • Clinical reference laboratories provide testing services for patients and healthcare providers • The labs performed are generally specialized tests that are infrequently ordered or that require specialized equipment

26. “Point of Care Testing” Point of Care Testing (POCT) is laboratory testing performed on simpler devices at the point of care (e.g., the bedside) and often by non-laboratory personnel

27. What is the Point of “POCT”? • The key objective of POCT is to produce a result more quickly • Therefore the utility of POCT is in the immediacy of responseand effect on medical decision making • Due to advances in technology, clinical needs and a number of other factors, POCT may be the most rapidly growing segment of laboratory testing worldwide

28. What POCT is available for the following patients? • 24-year old woman with amenorrhea x 2 months? • Urine HCG • 42-year old man with diabetes mellitus? • Glucose, HgbA1c, urine microalbumin • 63-year old woman with atrial fibrillation on warfarin • INR • 78-year old man presenting to the ED with 10/10 crushing chest pain • Troponin

29. Case Scenario 2 • A 5-year old boy is at his physician’s office with fever, sore throat and severe pain with swallowingx 2 days. • On physical exam his temperature is 390C. There is tonsillarerythema and swelling with white exudates. • What point of care test do you think was performed? • A rapid Streptococcal antigen test • The test is positive. How does this impact the care of the patient? • Appropriate antibiotics are prescribed • What if the test were negative? • The physician understands the sensitivity and predictive value of the rapid antigen test. If the clinical suspicion for Streptococcal pharyngitis is high a throat culture would be submitted

30. Case Scenario 3 • A 5-year old boy is at his physician’s office with low grade fevers, sore throat, runny nose, watery eyes for the past week. • On physical exam he is afebrile. There is minimal tonsillar swelling and erythemawithout exudates. The boy’s parents insist that he be treated with antibiotics. • The physician has a low clinical suspicion for Streptococcal pharyngitis but does perform a POCT Strep antigen screen. The result is negative. How does this impact patient care? • Support to not provide unnecessary antibiotic therapy for what is likely a viral upper respiratory tract infection

31. History of laboratory tests