Podcast
Questions and Answers
What is the main purpose of a laboratory quality manual?
What is the main purpose of a laboratory quality manual?
- To outline the quality management system for diagnostic laboratories (correct)
- To manage laboratory financial accounts
- To provide procedures for laboratory staff training
- To document patient information
Which organization is NOT mentioned as a collaborator in the development of the handbook?
Which organization is NOT mentioned as a collaborator in the development of the handbook?
- European Centre for Disease Prevention and Control (correct)
- Clinical and Laboratory Standards Institute
- CDC Division of Laboratory Systems
- WHO Lyon Office
What international standard is associated with the implementation in diagnostic laboratories?
What international standard is associated with the implementation in diagnostic laboratories?
- ISO 9001
- ISO 15189 (correct)
- ISO 17025
- ISO 14001
How many countries have been involved in the training sessions and modules provided by the CDC and WHO?
How many countries have been involved in the training sessions and modules provided by the CDC and WHO?
What is stated at the end of the content regarding the document setup?
What is stated at the end of the content regarding the document setup?
What is the primary reason for organizing work benches by the type of analysis performed?
What is the primary reason for organizing work benches by the type of analysis performed?
Which area is typically cleaned by cleaning staff in the laboratory?
Which area is typically cleaned by cleaning staff in the laboratory?
How often should laboratory ceilings and walls be cleaned based on general recommendations?
How often should laboratory ceilings and walls be cleaned based on general recommendations?
What should be recorded after cleaning and disinfecting laboratory areas?
What should be recorded after cleaning and disinfecting laboratory areas?
Who is often responsible for developing a laboratory safety programme?
Who is often responsible for developing a laboratory safety programme?
Which personnel might take responsibility for laboratory safety in smaller laboratories?
Which personnel might take responsibility for laboratory safety in smaller laboratories?
What is a recommended frequency for cleaning refrigerators in the laboratory?
What is a recommended frequency for cleaning refrigerators in the laboratory?
What type of documents should be available on work benches for reference during work?
What type of documents should be available on work benches for reference during work?
What is the first phase in the laboratory process?
What is the first phase in the laboratory process?
Which phase follows the sample collection in laboratory procedures?
Which phase follows the sample collection in laboratory procedures?
What is the ultimate goal of laboratory quality management?
What is the ultimate goal of laboratory quality management?
During which phase are lab results interpreted?
During which phase are lab results interpreted?
What does the complexity of the laboratory system demand?
What does the complexity of the laboratory system demand?
What is a key component of the laboratory examination phase?
What is a key component of the laboratory examination phase?
Which of the following is NOT part of the laboratory's workflow?
Which of the following is NOT part of the laboratory's workflow?
What happens after report creation in the laboratory process?
What happens after report creation in the laboratory process?
What is a primary consideration for the laboratory's power supply?
What is a primary consideration for the laboratory's power supply?
What should be considered when disposing of liquid wastes in laboratories?
What should be considered when disposing of liquid wastes in laboratories?
What type of paint or coating is recommended for laboratory walls and ceilings?
What type of paint or coating is recommended for laboratory walls and ceilings?
Which material is considered the best for laboratory work benches when it comes to cleaning and resistance to deterioration?
Which material is considered the best for laboratory work benches when it comes to cleaning and resistance to deterioration?
What is a potential disadvantage of using steel for laboratory benchtops?
What is a potential disadvantage of using steel for laboratory benchtops?
What is a crucial feature for the ventilation system in a laboratory?
What is a crucial feature for the ventilation system in a laboratory?
Which type of flooring is recommended in a laboratory?
Which type of flooring is recommended in a laboratory?
Why should wood not be used for laboratory work benches?
Why should wood not be used for laboratory work benches?
What is the primary purpose of risk assessment in a laboratory setting?
What is the primary purpose of risk assessment in a laboratory setting?
Which of the following is NOT mentioned as a significant physical risk encountered by laboratory staff?
Which of the following is NOT mentioned as a significant physical risk encountered by laboratory staff?
What percentage of laboratory personnel experienced lacerations according to the study?
What percentage of laboratory personnel experienced lacerations according to the study?
What is a critical aspect of safety procedures in laboratories?
What is a critical aspect of safety procedures in laboratories?
Which hazard relates to injuries caused by repeated motions in the laboratory?
Which hazard relates to injuries caused by repeated motions in the laboratory?
How does laboratory-acquired infection risk compare to physical hazards?
How does laboratory-acquired infection risk compare to physical hazards?
Which action is necessary after an employee has been exposed to a hazard?
Which action is necessary after an employee has been exposed to a hazard?
What is emphasized as a necessary training component for laboratory staff?
What is emphasized as a necessary training component for laboratory staff?
What is the major source of contamination in diagnostic laboratories?
What is the major source of contamination in diagnostic laboratories?
What must laboratories at containment level 2 ensure to minimize aerosol dissemination?
What must laboratories at containment level 2 ensure to minimize aerosol dissemination?
What is one of the primary routes by which laboratory staff acquire work-related infections?
What is one of the primary routes by which laboratory staff acquire work-related infections?
How far can contamination occur from its source in a laboratory setting?
How far can contamination occur from its source in a laboratory setting?
What essential resource must laboratory staff have to reduce the risk of work-related infections?
What essential resource must laboratory staff have to reduce the risk of work-related infections?
Which disease is linked to the source of 9 lyophilized ampoules dropped?
Which disease is linked to the source of 9 lyophilized ampoules dropped?
What type of inoculation is associated with murine typhus infection?
What type of inoculation is associated with murine typhus infection?
Which infection is transmitted through the accidental exposure to spilled mouse tissue?
Which infection is transmitted through the accidental exposure to spilled mouse tissue?
What is the consequence of a sample being damaged during collection or transport?
What is the consequence of a sample being damaged during collection or transport?
In which phase of the laboratory process do most errors typically occur?
In which phase of the laboratory process do most errors typically occur?
What is the primary purpose of understanding the path of workflow in a laboratory?
What is the primary purpose of understanding the path of workflow in a laboratory?
Which term is NOT commonly used to refer to the phases of laboratory processes?
Which term is NOT commonly used to refer to the phases of laboratory processes?
What is a key factor that impacts effective quality management in laboratory settings?
What is a key factor that impacts effective quality management in laboratory settings?
What major challenge do health laboratories face to ensure test results are trusted during international emergencies?
What major challenge do health laboratories face to ensure test results are trusted during international emergencies?
Which document forms the basis for the quality management topics covered in the handbook?
Which document forms the basis for the quality management topics covered in the handbook?
What framework is utilized in organizing the chapters of the handbook?
What framework is utilized in organizing the chapters of the handbook?
Who is responsible for providing comprehensive references on Laboratory Quality Management Systems?
Who is responsible for providing comprehensive references on Laboratory Quality Management Systems?
What is emphasized as a vital component for laboratories dedicated to international health regulations?
What is emphasized as a vital component for laboratories dedicated to international health regulations?
What is the main role of the contributors acknowledged in the document?
What is the main role of the contributors acknowledged in the document?
What overarching goal do the processes outlined in the handbook aim to achieve?
What overarching goal do the processes outlined in the handbook aim to achieve?
Which of the following best describes the scope of the handbook's audience?
Which of the following best describes the scope of the handbook's audience?
Which organization is responsible for coordinating International Health Regulations in Lyon?
Which organization is responsible for coordinating International Health Regulations in Lyon?
What is the main focus of the CDC's National Center for Preparedness?
What is the main focus of the CDC's National Center for Preparedness?
Which of the following facilities is located at 940 West Valley Road, Suite 1400?
Which of the following facilities is located at 940 West Valley Road, Suite 1400?
What is a key aspect mentioned regarding laboratory quality management systems?
What is a key aspect mentioned regarding laboratory quality management systems?
Which of the following sections is likely to discuss the importance of laboratory quality?
Which of the following sections is likely to discuss the importance of laboratory quality?
What is a typical subject found within the table of contents regarding laboratory management?
What is a typical subject found within the table of contents regarding laboratory management?
Which crucial element regarding laboratory management is hinted at in the provided content?
Which crucial element regarding laboratory management is hinted at in the provided content?
What type of document is expected to be referenced as essential during laboratory processes?
What type of document is expected to be referenced as essential during laboratory processes?
What is a critical responsibility of a laboratory director during the design and planning of new laboratory facilities?
What is a critical responsibility of a laboratory director during the design and planning of new laboratory facilities?
Which of the following is NOT a responsibility of a designated safety officer in a laboratory?
Which of the following is NOT a responsibility of a designated safety officer in a laboratory?
What is the primary purpose of recording staff exposures to hazards in a laboratory?
What is the primary purpose of recording staff exposures to hazards in a laboratory?
When designing the circulation paths in a laboratory, what is an essential consideration?
When designing the circulation paths in a laboratory, what is an essential consideration?
In the context of laboratory safety management, what is an important factor to assess when introducing new diagnostic techniques?
In the context of laboratory safety management, what is an important factor to assess when introducing new diagnostic techniques?
Which physical risk accounts for the highest percentage of injuries among laboratory staff?
Which physical risk accounts for the highest percentage of injuries among laboratory staff?
Which fundamental aspect does EVERY laboratory personnel need to understand?
Which fundamental aspect does EVERY laboratory personnel need to understand?
When assessing risks, which factor is essential for developing effective preventive measures?
When assessing risks, which factor is essential for developing effective preventive measures?
What role does a safety officer play in a laboratory setting?
What role does a safety officer play in a laboratory setting?
What is a primary responsibility of a laboratory quality manager?
What is a primary responsibility of a laboratory quality manager?
Which type of accident has the lowest reported incidence among laboratory hazards?
Which type of accident has the lowest reported incidence among laboratory hazards?
What is a major consideration when developing new activities in the laboratory?
What is a major consideration when developing new activities in the laboratory?
What must be emphasized to mitigate repetitive stress injuries in laboratory environments?
What must be emphasized to mitigate repetitive stress injuries in laboratory environments?
Why is it important for the reception desk to be located close to the entry door in a laboratory?
Why is it important for the reception desk to be located close to the entry door in a laboratory?
Which factor contributes to the necessity of ongoing risk assessments in laboratories?
Which factor contributes to the necessity of ongoing risk assessments in laboratories?
What is the recommended action for laboratory staff after an incident involving exposure to a hazard?
What is the recommended action for laboratory staff after an incident involving exposure to a hazard?
What is a necessary step when moving compressed gas cylinders in a laboratory?
What is a necessary step when moving compressed gas cylinders in a laboratory?
What is the recommended method for recapping needles to ensure safety?
What is the recommended method for recapping needles to ensure safety?
What type of container should sharps be disposed of in?
What type of container should sharps be disposed of in?
Which of the following materials is NOT considered a sharp for disposal purposes?
Which of the following materials is NOT considered a sharp for disposal purposes?
What is the proper disposal method for contaminated laboratory glass?
What is the proper disposal method for contaminated laboratory glass?
What precaution should be taken when storing compressed gas cylinders?
What precaution should be taken when storing compressed gas cylinders?
What must be done to a sharps container that contains non-biohazardous sharps?
What must be done to a sharps container that contains non-biohazardous sharps?
Why is it important to label sharps containers clearly?
Why is it important to label sharps containers clearly?
Flashcards
Sample Collection
Sample Collection
The process where a blood or tissue sample is taken from a patient for analysis in a laboratory.
Sample Transport
Sample Transport
The phase of a laboratory testing process where the collected sample is transported from the collection site to the laboratory for analysis.
Laboratory Analysis
Laboratory Analysis
The phase where the sample is analyzed in the laboratory using various techniques and equipment.
Result Interpretation
Result Interpretation
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Report Creation
Report Creation
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Report Transport
Report Transport
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Pre-Examination
Pre-Examination
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Quality Management
Quality Management
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Liquid Waste Management
Liquid Waste Management
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Emergency Generator
Emergency Generator
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Stable Power Supply
Stable Power Supply
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Disinfection
Disinfection
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Durable Benchtop
Durable Benchtop
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Ceramic Tiles
Ceramic Tiles
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Wood
Wood
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Steel
Steel
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Work bench organization
Work bench organization
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Microbiology work bench separation
Microbiology work bench separation
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Laboratory cleaning schedule
Laboratory cleaning schedule
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Benchtop cleaning and disinfection
Benchtop cleaning and disinfection
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Floor cleaning
Floor cleaning
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Cleaning and disinfection record
Cleaning and disinfection record
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Laboratory safety programme
Laboratory safety programme
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Laboratory safety officer
Laboratory safety officer
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Risk assessment in labs
Risk assessment in labs
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Lab safety procedures
Lab safety procedures
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Recording lab safety incidents
Recording lab safety incidents
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Physical risks in labs
Physical risks in labs
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Lab-acquired infections
Lab-acquired infections
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Safety training for lab equipment
Safety training for lab equipment
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Why lab safety matters
Why lab safety matters
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Lab director's safety role
Lab director's safety role
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Aerosol Transmission
Aerosol Transmission
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Physical Containment Level 2 Lab
Physical Containment Level 2 Lab
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Containment System
Containment System
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Inward Airflow
Inward Airflow
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Absolute Filtration
Absolute Filtration
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Personal Protective Equipment (PPE)
Personal Protective Equipment (PPE)
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Percutaneous Inoculation
Percutaneous Inoculation
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Mucous Membrane Contact
Mucous Membrane Contact
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Laboratory Quality Management System
Laboratory Quality Management System
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Laboratory Quality Manual
Laboratory Quality Manual
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Implementation
Implementation
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Organizational functions
Organizational functions
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Handbook Development
Handbook Development
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Laboratory Quality Management
Laboratory Quality Management
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Importance of Laboratory Quality
Importance of Laboratory Quality
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History of Laboratory Quality Management
History of Laboratory Quality Management
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Quality Management System Model
Quality Management System Model
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Laboratory Quality Management System (LQMS)
Laboratory Quality Management System (LQMS)
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Laboratory Quality Management System Handbook
Laboratory Quality Management System Handbook
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Achieving Quality in Laboratories
Achieving Quality in Laboratories
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Trustworthy Lab Results
Trustworthy Lab Results
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Path of Workflow
Path of Workflow
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Examination
Examination
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Laboratory Design: Patient and Sample Pathways
Laboratory Design: Patient and Sample Pathways
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Needles and sharps disposal
Needles and sharps disposal
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Sharps container
Sharps container
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Safe needle recapping
Safe needle recapping
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Study Notes
Laboratory Quality Management System Handbook
- This handbook is a guide for laboratory quality management systems, developed by the World Health Organization, the Centers for Disease Control and Prevention (CDC), and the Clinical and Laboratory Standards Institute (CLSI).
- It provides detailed information on various aspects, including facilities and safety, equipment, purchasing and inventory, process control (covering sample management, quantitative and qualitative tests), assessment and accreditation, and personnel.
- The document emphasizes the importance of a quality management system in laboratories to ensure accuracy, reliability, timeliness of test results, and good patient care.
- This comprehensive guide focuses on the 12 Quality System Essentials, from organization to personnel to facilities, to ensure quality.
- It adheres to international standards (such as ISO 15189 and CLSI GP26-A3).
- The handbook was developed based on training sessions and modules for more than 25 countries.
- It includes guidelines for implementing ISO 15189 in diagnostic laboratories.
Contacts
- WHO Lyon Office - International Health Regulations Coordination
- CDC - National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID)
- Clinical and Laboratory Standards Institute (CLSI)
- WHO Collaborating Center for Clinical and Laboratory Standards
- The Centers for Medicare and Medicaid Services (CMS) (in the context of US requirements)
Acknowledgements
- This handbook was developed through collaboration between the WHO, CDC, and CLSI.
- Many individuals (Adilya Albetkova, Robin Barteluk, Anouk Berger, Sébastien Cognat, Carlyn Collins, Philippe Dubois, Christelle Estran, Glen Fine, Sharon Granade, Stacy Howard, Devery Howerton, Kazunobu Kojima, Xin Liu, Jennifer McGeary, Robert Martin, Sylvio Menna, Michael Noble, Antoine Pierson, Anne Pollock, Mark Rayfield, John Ridderhof, Eunice Rosner, Joanna Zwetyenga) and organizations are acknowledged, contributing to its development and review.
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