SHE, Quality, and Ethics in Medical Laboratories - PCLP


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Safety, Health, Environment, Quality, and Ethics in Medical Laboratories.

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SHE, Quality, and Ethics in Medical Laboratories - PCLP

  1. 1. Agreement We are Environmental Friendly: 1) We don’t smoke in Al-Academia. 2) We Save Electricity 3) We Save Water 4) We don’t Print unnecessary Papers Go Green .. And be one of us 
  2. 2. Please !! • Don’t Be Late. • Set your mobile on Vibration. • Give me space to share my knowledge. • Keep discussions with instructor only. • And again Go Green 
  3. 3. Medical Laboratory Introduction, SHE, Quality, and Ethics Professional Clinical Laboratory Practitioner - PCLP
  4. 4. Agenda • Introduction to Medical Laboratories • Quality in Medical Laboratories. • Safety, Health, and Environment. • Ethics in Medical Laboratories.
  5. 5. Introduction to Medical Laboratory
  6. 6. Points of Discussion • Types of Laboratories • Medical Laboratories • Departments (Clinical – Administrative) • Types of Staff • Workflow Processes • Types of Analysis • Laboratory Information System (LIS) • Accreditation
  7. 7. Types of Laboratories • Hospital Laboratories • Private (Community) Laboratories • Reference Laboratories • Research Laboratories • Molecular Diagnostics or Cytogenetics and Molecular Biology Laboratories.
  8. 8. Medical Laboratories • Or so called Clinical Laboratories. • Definition; is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient that are related to the diagnosis, treatment, and prevention of diseases.
  9. 9. Types of Departments • Clinical (Technical) Departments • Administrative Departments
  10. 10. Types of Clinical Departments • Anatomic Pathology; histopathology, cytopathology. • Clinical Pathology: 1) Clinical Chemistry 2) Clinical Microbiology; Bacteriology, Mycology, Virology. 3) Haematology 4) Immunology 5) Molecular Biology 6) Parasitology
  11. 11. Types of Clinical Departments (Cont.) 7) Hormones 8) Tumor markers 9) Reproductive Biology; semen analysis, Sperm Banks, Cord banks. 10) Cytogenetics 11) Drugs and Doping
  12. 12. Types of Administrative Departments 1) 2) 3) 4) 5) 6) 7) Administration Human Resources Finance and Accounting Customer Service Public Relations Marketing Sales
  13. 13. Types of Staff • Pathologist, • Clinical Biochemist • Pathologist assistant (PA) • Biomedical Scientist (BMS) in the UK • Medical Laboratory Scientist (MT, MLS or CLS) in the US • Medical Laboratory Technologist (MLT) in Canada, • Medical Laboratory Technician (MLT in US) • Medical Laboratory Assistant (MLA) • Phlebotomist (PBT)
  14. 14. Workflow Processes • Requesting • Sampling • Sample Processing • Analysis, Validation, and Interpretation. • Resulting • Recording and Logging • Reporting
  15. 15. Types of Analysis • Manual Analysis: 1) Low rate Samples 2) Small Private Laboratories 3) Confirmatory Testing • Automated Analysis: 1) High Rate Samples 2) High Accuracy Results (Low Human Intervention) 3) Other Activities During Analysis
  16. 16. Laboratory Information System (LIS) • Archiving • Low Effort – Less Time • Traceability • Validation and Control • Reports and Statistics • Financials • Inventory Control • Integration
  17. 17. Accreditation • ISO 189 – International Standards Organization (ISO); USA. Particular Requirements for Quality and Competence. • Joint Commission (JCAHO); USA. • College of American Pathologists (CAP); USA. • American Association of Bioanalysts (AAB); USA. • Clinical Laboratory Improvement Amendments (CLIA); USA. • NATA (Austraia) • COFRAC (France)
  18. 18. Discussion
  19. 19. Quality in Medical Laboratory
  20. 20. Points of Discussion • What is Quality? • What is Quality Control? • Importance of Quality Control • Terms and Definitions • Types of Quality Control
  21. 21. What is Quality? • Definition (1): The standard of something as measured against other things of a similar kind. • Definition (2): The degree of excellence of something. • Definition (3): A distinctive attribute or characteristic possessed by someone or something.
  22. 22. What is Quality Control? • It is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects: 1) Main Elements: Controls, Job Management, Processes, ..etc. 2) Competences: Knowledge, Skills, Experience, ...etc. 3) Soft Elements: Personnel, Organizational Structure, Structure, ..etc. • Quality Control in Medical Laboratories; is a statistical process used to monitor and evaluate the analytical process that produces patient results.
  23. 23. Importance of Quality Control • Meeting Standards (Internal or Laws) • Maintaining Quality Standards • Monitoring Errors and Mistakes • Satisfying Customers • Building Good Reputation • Analysis and Improvement
  24. 24. Terms and Definitions • Errors vs. Mistakes • Precision vs. Accuracy • Repeatability vs. Reproducibility • Random Errors (RE) • Systematic Errors (SE) • Gross Errors (GE)
  25. 25. Errors vs. Mistakes Errors Mistakes Non-conforming results with “statistical meaning”. Non-conforming results with “no statistical meaning”. This category includes all the “wrong” laboratory measures due to non-human action. This category contains all the human errors e.g. mixing up samples.
  26. 26. Classification of Errors ad Mistakes: • Pre-Analytical Stage • Analytical Stage • Post-Analytical Stage
  27. 27. Pre-Analytical Stage Errors and Mistakes Ex.: 1) 2) 3) 4) 5) Inappropriate specimen (e.g. wrong specimen-anticoagulant ratio). Wrong anticoagulant (e.g. sodium citrate in place of EDTA). Improper conservation method. Inappropriate patient’s preparation (e.g. wrong diet). Mistakes in patients’ identification.
  28. 28. Analytical Stage Errors and Mistakes Ex.: 1) 2) 3) 4) 5) 6) 7) Expired reagents which may lead to erroneous results. Expired controls or calibrators. Calibration curve time-out elapsed. Failure in sampling system. Failure in aspiration system of reagents. Changes in analyzer’s photometric unit / flow cell / measuring unit. Any other analyzer’s failure.
  29. 29. Post-Analytical Stage Errors and Mistakes Ex.: 1) Wrong matching between sample and laboratory’s files. 2) Wrong copy of results from the analyzer’s report to the laboratory report (in cases of manual transfer). 3) Delay in delivering the results to the physicians, clinics or patients. 4) Loss of the results.
  30. 30. Precision vs. Accuracy Precision Accuracy The closeness of agreement between independent test results obtained under stipulated conditions. The closeness of the agreement between the result of a measurement and a true value of the measurand.
  31. 31. Precision vs. Accuracy
  32. 32. Precision vs. Accuracy
  33. 33. Repeatability vs. Reproducibility Repeatability The degree of consensus between successive measurements which have been done on the same sample with very similar conditions (same analyzer, same user, same laboratory, same methods, same lot of reagents) in a very short time (e.g. same day). It is approached by within run or within day experiments. Reproducibility The degree of consensus between successive measurements achieved on the same sample with different conditions (e.g. different analyzer, different user, different lot of reagents) in a long time. It is approached by between day experiments, can be either intralaboratory or inter-laboratory.
  34. 34. Random Errors (RE) Errors in measurement that lead to measurable values being inconsistent when repeated measures of a constant attribute or quantity are taken.
  35. 35. Systematic Errors (SE) A component of error which, in the course of a number of analyses of the same measurand, remains constant or varies in a predictable way.
  36. 36. Gross Errors (GE) Errors that make the measurement very far off of the known/accepted value; can be defined as mistakes.
  37. 37. Illustration of Types of Errors
  38. 38. Types of Quality Control • Internal Quality Control • External Quality Control
  39. 39. Internal Quality Control It concludes all SQC methods which are performed every day by the laboratory personnel with the laboratory’s materials and equipment. It checks primarily the precision (repeatability or reproducibility) of the method.
  40. 40. Terms in IQC • Normal Distribution • Mode • Median • Mean or Average
  41. 41. Normal Distribution • X-axis represents the values of a variable’s observations • Y-axis the frequency of each value (the number of each value’s appearance). • It has a bell-shaped form with its two edges approaching the x-axis.
  42. 42. Mode, Median, and Mean(Average) 1) Mode (Mo); the value with the highest frequency. 2) Median (M); the value which divides the variable’s observations in two equal parts. 3) Mean (Average); the value which all the observations should have if they were equal.
  43. 43. Quiz 1,2,2,3,5,6,2 What is the Mode? What is the Median? What is the Mean?
  44. 44. External Quality Control It concludes all SQC methods which are performed periodically (i.e. every month, every two months, twice a year) by the laboratory personnel with the contribution of an external center (referral laboratory, scientific associations, diagnostic industry etc.). It checks primarily the accuracy of the laboratory’s analytical methods. Proficiency Test (PT) External Quality Assessments Schemes (EQAS)
  45. 45. Discussion
  46. 46. SHE in Medical Laboratory From the OSHA Laboratory Safety Guidance
  47. 47. Points of Discussion 1) Types of Hazards in Medical Laboratories. 2) Safety Signs in Medical Laboratories
  48. 48. Types of Hazards in Medical Laboratories • Chemical Hazards • Physical Hazards • Biological Hazards • Safety Hazards
  49. 49. Chemical Hazards • Carcinogens; cancer-causing agents. • Toxins; those affecting the liver, kidney, and nervous system. • Corrosives; a substance that causes a destruction of a substance in contact. • Sensitizers & Irritants; a substance that causes exposed people to develop an allergic reaction in normal tissue after repeated exposure to the substance.
  50. 50. Recommendations • Labelling and Identification • Safe Inventory • Safe Handling and Transportation • Material Safety Data Sheets (MSDS) • Information and Training • Exposure Determination • Medical Consultations and Examinations
  51. 51. Material Safety Data Sheets (MSDS) 1. Name of the chemical; 2. Manufacturer’s information; 3. Hazardous ingredients/identity information; 4. Physical/chemical characteristics; 5. Fire and explosion hazard data; 6. Reactivity data; 7. Health hazard data; 8. Precautions for safe handling and use; and 9. Control measures.
  52. 52. Examples of Chemical Hazards
  53. 53. Safety Signs for Chemical Hazards
  54. 54. Physical Hazards • Ergonomic Hazards; using hoods, microscopes, pipetting, cell counters, seats, computer work. • Ionizing Radiation; Radioactive Isotopes. • Non-Ionizing Radiation; UV, IR, Microwave (MW), Visible Light, Radio Frequency (RF). • Noise; freezers, refrigerators, centrifuges, autoclaves.
  55. 55. Biological Hazards • Blood and Body Fluids • Body Tissues and Cadavers • Culture Specimens • Laboratory Animals Blood Born Pathogens (BBP)
  56. 56. Dealing with BBP • Mouth Pipetting • Eating, Drinking, Smoking, Applying Cosmetics or Lip palm, Contact Lenses. • Storage of Food and Drinks in Laboratory Refrigerators. • Providing appropriate PPE. • Using Engineering Controls; Safety and Biological Hoods.
  57. 57. Safety Hazards • Autoclaves and Sterilizers • Centrifuges • Compressed Gases • Cryogens and Dry Ice • Electricity • Fire and Hot Surfaces • Lockout/Tagout • Trips, Slips, and Falls.
  58. 58. Safety Signs
  59. 59. Safety Signs
  60. 60. Safety Signs
  61. 61. Safety Signs
  62. 62. Discussion
  63. 63. Ethics in Medical Laboratory
  64. 64. Ethics in Medical Laboratories • Ethics towards Profession • Ethics towards Premises • Ethics towards Patient • Ethics towards Community
  65. 65. Discussion
  66. 66. Thank you 
  67. 67. Contact us Telephone: +(202) 22744556 Fax: +(202) 22744679 Mobile: +(2010) 12371716 Email: URL: Facebook: