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

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4. Medical Laboratory
Introduction, SHE, Quality,
and Ethics
Professional Clinical Laboratory Practitioner - PCLP

5. Agenda
• Introduction to Medical Laboratories
• Quality in Medical Laboratories.
• Safety, Health, and Environment.
• Ethics in Medical Laboratories.

6. Introduction to
Medical Laboratory

7. Points of Discussion
• Types of Laboratories
• Medical Laboratories
• Departments (Clinical – Administrative)
• Types of Staff
• Workflow Processes
• Types of Analysis
• Laboratory Information System (LIS)
• Accreditation

8. Types of Laboratories
• Hospital Laboratories
• Private (Community) Laboratories
• Reference Laboratories
• Research Laboratories
• Molecular Diagnostics or Cytogenetics and Molecular Biology
Laboratories.

9. 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.

10. Types of Departments
• Clinical (Technical) Departments
• Administrative Departments

11. 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

12. 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

13. Types of Administrative Departments
1)
2)
3)
4)
5)
6)
7)
Administration
Human Resources
Finance and Accounting
Customer Service
Public Relations
Marketing
Sales

14. 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)

15. Workflow Processes
• Requesting
• Sampling
• Sample Processing
• Analysis, Validation, and Interpretation.
• Resulting
• Recording and Logging
• Reporting

16. 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

17. Laboratory Information System (LIS)
• Archiving
• Low Effort – Less Time
• Traceability
• Validation and Control
• Reports and Statistics
• Financials
• Inventory Control
• Integration

18. 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)

19. Discussion

20. Quality in
Medical Laboratory

21. Points of Discussion
• What is Quality?
• What is Quality Control?
• Importance of Quality Control
• Terms and Definitions
• Types of Quality Control

22. 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.

23. 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.

24. Importance of Quality Control
• Meeting Standards (Internal or Laws)
• Maintaining Quality Standards
• Monitoring Errors and Mistakes
• Satisfying Customers
• Building Good Reputation
• Analysis and Improvement

25. Terms and Definitions
• Errors vs. Mistakes
• Precision vs. Accuracy
• Repeatability vs. Reproducibility
• Random Errors (RE)
• Systematic Errors (SE)
• Gross Errors (GE)

26. 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.

27. Classification of Errors ad Mistakes:
• Pre-Analytical Stage
• Analytical Stage
• Post-Analytical Stage

28. 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.

29. 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.

30. 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.

31. 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.

32. Precision vs. Accuracy

33. Precision vs. Accuracy

34. 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.

35. Random Errors (RE)
Errors in measurement that lead to measurable values
being inconsistent when repeated measures of
a constant attribute or quantity are taken.

36. 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.

37. Gross Errors (GE)
Errors that make the measurement very far off of the
known/accepted value; can be defined as mistakes.

38. Illustration of Types of Errors

39. Types of Quality Control
• Internal Quality Control
• External Quality Control

40. 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.

41. Terms in IQC
• Normal Distribution
• Mode
• Median
• Mean or Average

42. 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.

43. 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.

44. Quiz
1,2,2,3,5,6,2
What is the Mode?
What is the Median?
What is the Mean?

45. 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)

46. Discussion

47. SHE in
Medical Laboratory
From the OSHA Laboratory Safety Guidance

48. Points of Discussion
1) Types of Hazards in Medical Laboratories.
2) Safety Signs in Medical Laboratories

49. Types of Hazards in Medical Laboratories
• Chemical Hazards
• Physical Hazards
• Biological Hazards
• Safety Hazards

50. 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.

51. Recommendations
• Labelling and Identification
• Safe Inventory
• Safe Handling and Transportation
• Material Safety Data Sheets (MSDS)
• Information and Training
• Exposure Determination
• Medical Consultations and Examinations

52. 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.

53. Examples of Chemical Hazards

54. Safety Signs for Chemical Hazards

55. 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.

56. Biological Hazards
• Blood and Body Fluids
• Body Tissues and Cadavers
• Culture Specimens
• Laboratory Animals
Blood Born Pathogens (BBP)

57. 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.

58. Safety Hazards
• Autoclaves and Sterilizers
• Centrifuges
• Compressed Gases
• Cryogens and Dry Ice
• Electricity
• Fire and Hot Surfaces
• Lockout/Tagout
• Trips, Slips, and Falls.

59. Safety Signs

60. Safety Signs

61. Safety Signs

62. Safety Signs

63. Discussion

64. Ethics in
Medical Laboratory

65. Ethics in Medical Laboratories
• Ethics towards Profession
• Ethics towards Premises
• Ethics towards Patient
• Ethics towards Community

66. Discussion

67. Thank you 

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