01 Introduction to Clinical Biochemistry II 03-07.pptx

Bio chemistry Introduction

1. Introduction to Clinical Biochemistry II

2. Topics Introduction to clinical biochemistry - Quality Assurance Serum Electrolytes Principles of human nutrition / energy and protein requirement Nutritional Assessment Mineral and deficiency Vitamin and deficiency Urine analysis

3. Assessment Physical Theory: 30% 20 MCQ 1 Hour 30% 4 SEQ 2 Hours Practical: 30% OSPE 10% Assignment (dissertation) Online PSA – 25% TA – 25% OBT – 50%

4. Recommended Reading Carl Burtis , Edward Ashwood , and David Bruns , Tietz , Textbook of Clinical Chemistry and Molecular Diagnostics – (Latest edition), Saunders William J. Marshall, Stephen K Bangert and MártaLapsley , Clinical Chemistry – (Latest edition), Mosby Alan Wu. Teitz clinical guide to laboratory tests - (Latest edition), Saunders Thomas M Devlin, Textbook of Biochemistry with clinical correlations – (Latest edition), John Wiley & sons

5. Chemical pathology, Provide biochemical information for the management of patients Accurate Relevant

6. Use of Biochemical investigation Screening – detection of subclinical disease Diagnosis – confirmation or rejection of clinical diagnosis Prognosis – information regarding the likely outcome of the disease Monitoring – progression or response to treatment

7. Right results, at the right time, on the right specimen, from the right patient, with result interpretation based on correct reference date and at the right place. Accuracy Precision What are the consequence of poor quality laboratory ?

8. 1. Pre-Analytical phase Investigation and ordering of test – request form Patient preparation Quantity Collection technique Labeling Collection container Storage and transportation

9. 2. Analytical phase Proficiency of personnel Reagent's stability, integrity and efficiency Equipment reliability Use of appropriate controls Specificity and sensitivity of selected test Procedural reliability using SOP Documentation

10. Analytical methods Manual methods Reagent kit method – Manual/ Automated/ Semi-automated Colorimetric method Kinetic method Chemical method Strip method

11. Ideal analytical method Accurate – give correct results Precise – same results if repeat Sensitive – measure low concentration of the analyte Specific – not subject to interference by other substance Cheap Simple Less time consuming

12. Accuracy The closeness of a measurement to its true value Precision Is the amount of variation in the measurement

13. Not precise Precise Not accurate Accurate

14. Bias The difference between a laboratory's average value for a test item and the average that would be achieved by the reference laboratory if it undertook the same measurements on the same test item. How to reduce bias?

15. Standard Operating Procedures (SOP) To provide laboratory staff with written instructions on how to perform tests consistently to an acceptable standard in their laboratory To prevent changes in the performance of tests which may occur when new members of staff are appointed. SOPs also help to avoid short-cuts being taken when performing tests. To provide written standardized techniques for use in the training of laboratory personnel and for potential publication in scientific journals. To facilitate the preparation of a list and inventory of essential reagents, chemicals and equipment To promote safe laboratory practice

16. Quality Control QC is statistical measurement process to verify the method whether it continuous to perform within the specifications consistent with acceptable systemic bias and imprecision

17. Characteristics of control materials Must be appropriate for the targeted diagnostic test The amount of the analyte present in the control should be close to the medical decision points (normal and pathological range) Controls should have the same matrix as patient samples Stable Available in aliquots/vials Responsive to being analyzed periodically over a long time Control materials may be Purchased Obtained from a central or reference laboratory Made in house by pooling sera from different patients

18. Internal Quality Control (IQC) Detect, reduce, correct the errors in internal laboratory analytical process prior to test result issue. Continuously and concurrently assessing lab work Beginning of each shift After instrument Service Reagents lots changed After Calibration Most of the time provide with kit or included in testing device In IQC we know the values (mean/SD) within the laboratory, can assess the results

19. External Quality Control (EQC) Provide by external source Used to validate the reliability of the test system Prepared by reference laboratory EQC providers BIORAD NEQAS EQC laboratory person don’t know the values.Results assess by EQC providers.

20. Quality Satisfaction of the needs and expectations of users Importance Quality Assurance Ensuring quality test results. Purpose is to give relevant, reliable, timely test results which is interpreted accurately. Involves activities in both inside and outside laboratory, good laboratory practices, proper management skills. Click to add text

21. 3. Post Analytical phase Right recording and reporting Right interpretation Right turnaround time Report to right user

22. The complexity of the laboratory system requires that many factors must be addressed to assure quality in the laboratory. The laboratory environment Quality control procedures Communications Record keeping Competent and knowledgeable staff Good-quality reagents and equipment.

23. Quality Assurance Minimizing laboratory error the quality management system model, which looks at the entire system, is very important for achieving good laboratory performance Quality = Internal + External Assurance Assurance Assurance

24. Internal quality Assessment Set of procedures undertaken by the staff to ensure quality of reports Total process beginning with sample collection up to final reporting Continuously and concurrently assessing lab work. Both outside and within laboratory factors are involved. Click to add text

25. Quality system “organizational structure, resources, processes and procedures needed to implement quality management”

26. International Laboratory Standards Need for international laboratory standards A part of quality management is assessment/ measuring performance against a standard or benchmark The concept of quality management requires that standards to be set Important to maintain the standard of the Lab. ISO (International Organization for Standardization) CLSI (Clinical and Laboratory Standards Institute)

27. ISO The ISO 9000 documents provide guidance for quality in manufacturing and service industries, and can be broadly applied to many other kinds of organizations. ISO 9001:2000 addresses general quality management system requirements that can apply to laboratories. There are two ISO standards that are specific to laboratories: ISO 15189:2007. Medical laboratories —requirements for quality and competence. ISO/IEC 17025:2005 . General requirements for the competence of testing and calibration laboratories

28. CLSI Formerly known as the National Committee for Clinical Laboratory Standards (NCCLS). CLSI has two documents that are very important in the clinical laboratory: A quality management system model for health care; approved guideline. Application of a quality management system model for laboratory services

29. Thank You!!