Laboratory Quality Manual Overview
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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?

  • 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?

  • 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?

    <p>25</p> Signup and view all the answers

    What is stated at the end of the content regarding the document setup?

    <p>It provides chapters with references and resources</p> Signup and view all the answers

    What is the primary reason for organizing work benches by the type of analysis performed?

    <p>To minimize risks of cross-contamination</p> Signup and view all the answers

    Which area is typically cleaned by cleaning staff in the laboratory?

    <p>Floors</p> Signup and view all the answers

    How often should laboratory ceilings and walls be cleaned based on general recommendations?

    <p>Weekly</p> Signup and view all the answers

    What should be recorded after cleaning and disinfecting laboratory areas?

    <p>The date and name of the person performing the maintenance</p> Signup and view all the answers

    Who is often responsible for developing a laboratory safety programme?

    <p>Laboratory safety officer</p> Signup and view all the answers

    Which personnel might take responsibility for laboratory safety in smaller laboratories?

    <p>Laboratory manager</p> Signup and view all the answers

    What is a recommended frequency for cleaning refrigerators in the laboratory?

    <p>Once a month</p> Signup and view all the answers

    What type of documents should be available on work benches for reference during work?

    <p>Standard operating procedures and job aids</p> Signup and view all the answers

    What is the first phase in the laboratory process?

    <p>Pre-examination phase</p> Signup and view all the answers

    Which phase follows the sample collection in laboratory procedures?

    <p>Sample transport</p> Signup and view all the answers

    What is the ultimate goal of laboratory quality management?

    <p>To assure quality in the laboratory</p> Signup and view all the answers

    During which phase are lab results interpreted?

    <p>Result interpretation phase</p> Signup and view all the answers

    What does the complexity of the laboratory system demand?

    <p>Addressing of multiple factors for quality assurance</p> Signup and view all the answers

    What is a key component of the laboratory examination phase?

    <p>Laboratory analysis</p> Signup and view all the answers

    Which of the following is NOT part of the laboratory's workflow?

    <p>Sample sorting</p> Signup and view all the answers

    What happens after report creation in the laboratory process?

    <p>Report transport</p> Signup and view all the answers

    What is a primary consideration for the laboratory's power supply?

    <p>To have a stable source and backup power</p> Signup and view all the answers

    What should be considered when disposing of liquid wastes in laboratories?

    <p>Local and national disposal regulations</p> Signup and view all the answers

    What type of paint or coating is recommended for laboratory walls and ceilings?

    <p>Glossy washable paint or suitable coating</p> Signup and view all the answers

    Which material is considered the best for laboratory work benches when it comes to cleaning and resistance to deterioration?

    <p>Ceramic tiles for their durability and ease of cleaning</p> Signup and view all the answers

    What is a potential disadvantage of using steel for laboratory benchtops?

    <p>It can rust when exposed to chlorine</p> Signup and view all the answers

    What is a crucial feature for the ventilation system in a laboratory?

    <p>It must ensure circulation for people and equipment</p> Signup and view all the answers

    Which type of flooring is recommended in a laboratory?

    <p>Easy-to-clean and disinfect flooring</p> Signup and view all the answers

    Why should wood not be used for laboratory work benches?

    <p>It supports microbial growth when damaged</p> Signup and view all the answers

    What is the primary purpose of risk assessment in a laboratory setting?

    <p>To manage and reduce risks to laboratory employees</p> Signup and view all the answers

    Which of the following is NOT mentioned as a significant physical risk encountered by laboratory staff?

    <p>Electric shock</p> Signup and view all the answers

    What percentage of laboratory personnel experienced lacerations according to the study?

    <p>32%</p> Signup and view all the answers

    What is a critical aspect of safety procedures in laboratories?

    <p>Describing actions in case of accidents or injuries</p> Signup and view all the answers

    Which hazard relates to injuries caused by repeated motions in the laboratory?

    <p>Repetitive stress</p> Signup and view all the answers

    How does laboratory-acquired infection risk compare to physical hazards?

    <p>It is persistent and cannot be reduced to zero.</p> Signup and view all the answers

    Which action is necessary after an employee has been exposed to a hazard?

    <p>Keeping a record of the exposure and actions taken</p> Signup and view all the answers

    What is emphasized as a necessary training component for laboratory staff?

    <p>Training in specific safety procedures</p> Signup and view all the answers

    What is the major source of contamination in diagnostic laboratories?

    <p>Aerosols</p> Signup and view all the answers

    What must laboratories at containment level 2 ensure to minimize aerosol dissemination?

    <p>Continuous inward airflow and absolute filtration</p> Signup and view all the answers

    What is one of the primary routes by which laboratory staff acquire work-related infections?

    <p>Accidental ingestion</p> Signup and view all the answers

    How far can contamination occur from its source in a laboratory setting?

    <p>Up to 70 feet</p> Signup and view all the answers

    What essential resource must laboratory staff have to reduce the risk of work-related infections?

    <p>Access to PPE</p> Signup and view all the answers

    Which disease is linked to the source of 9 lyophilized ampoules dropped?

    <p>Venezuelan encephalitis</p> Signup and view all the answers

    What type of inoculation is associated with murine typhus infection?

    <p>Intranasal inoculation</p> Signup and view all the answers

    Which infection is transmitted through the accidental exposure to spilled mouse tissue?

    <p>Coxsackie virus infection</p> Signup and view all the answers

    What is the consequence of a sample being damaged during collection or transport?

    <p>It may produce unreliable results.</p> Signup and view all the answers

    In which phase of the laboratory process do most errors typically occur?

    <p>Pre-examination phase</p> Signup and view all the answers

    What is the primary purpose of understanding the path of workflow in a laboratory?

    <p>To facilitate the development of quality practices.</p> Signup and view all the answers

    Which term is NOT commonly used to refer to the phases of laboratory processes?

    <p>Diagnostic</p> Signup and view all the answers

    What is a key factor that impacts effective quality management in laboratory settings?

    <p>The reliability of test result reporting</p> Signup and view all the answers

    What major challenge do health laboratories face to ensure test results are trusted during international emergencies?

    <p>Sound management of quality in health laboratories</p> Signup and view all the answers

    Which document forms the basis for the quality management topics covered in the handbook?

    <p>ISO 15189</p> Signup and view all the answers

    What framework is utilized in organizing the chapters of the handbook?

    <p>12 Quality System Essentials by CLSI</p> Signup and view all the answers

    Who is responsible for providing comprehensive references on Laboratory Quality Management Systems?

    <p>WHO, CDC, and CLSI</p> Signup and view all the answers

    What is emphasized as a vital component for laboratories dedicated to international health regulations?

    <p>Building national capacities for health event response</p> Signup and view all the answers

    What is the main role of the contributors acknowledged in the document?

    <p>Develop and review the training package</p> Signup and view all the answers

    What overarching goal do the processes outlined in the handbook aim to achieve?

    <p>Achieve reliable and trusted laboratory test results</p> Signup and view all the answers

    Which of the following best describes the scope of the handbook's audience?

    <p>All stakeholders involved in health laboratory processes</p> Signup and view all the answers

    Which organization is responsible for coordinating International Health Regulations in Lyon?

    <p>WHO Lyon Office</p> Signup and view all the answers

    What is the main focus of the CDC's National Center for Preparedness?

    <p>Preparedness, Detection, and Control of Infectious Diseases</p> Signup and view all the answers

    Which of the following facilities is located at 940 West Valley Road, Suite 1400?

    <p>Clinical and Laboratory Standards Institute</p> Signup and view all the answers

    What is a key aspect mentioned regarding laboratory quality management systems?

    <p>Integration of international laboratory standards</p> Signup and view all the answers

    Which of the following sections is likely to discuss the importance of laboratory quality?

    <p>Introduction to quality</p> Signup and view all the answers

    What is a typical subject found within the table of contents regarding laboratory management?

    <p>Overview of quality management systems</p> Signup and view all the answers

    Which crucial element regarding laboratory management is hinted at in the provided content?

    <p>Implementing a laboratory quality management system</p> Signup and view all the answers

    What type of document is expected to be referenced as essential during laboratory processes?

    <p>Laboratory quality management guidelines</p> Signup and view all the answers

    What is a critical responsibility of a laboratory director during the design and planning of new laboratory facilities?

    <p>Assess all potential risks and provide a safe environment</p> Signup and view all the answers

    Which of the following is NOT a responsibility of a designated safety officer in a laboratory?

    <p>Conduct extensive research on laboratory equipment</p> Signup and view all the answers

    What is the primary purpose of recording staff exposures to hazards in a laboratory?

    <p>To prevent future occurrences</p> Signup and view all the answers

    When designing the circulation paths in a laboratory, what is an essential consideration?

    <p>Keeping patient samples away from public areas</p> Signup and view all the answers

    In the context of laboratory safety management, what is an important factor to assess when introducing new diagnostic techniques?

    <p>Potential risks associated with the techniques</p> Signup and view all the answers

    Which physical risk accounts for the highest percentage of injuries among laboratory staff?

    <p>Laceration</p> Signup and view all the answers

    Which fundamental aspect does EVERY laboratory personnel need to understand?

    <p>Basic safety rules and biosafety management issues</p> Signup and view all the answers

    When assessing risks, which factor is essential for developing effective preventive measures?

    <p>Variety of lab analyses performed</p> Signup and view all the answers

    What role does a safety officer play in a laboratory setting?

    <p>They help identify potential risks</p> Signup and view all the answers

    What is a primary responsibility of a laboratory quality manager?

    <p>Ensure training in safety rules and organizational policies</p> Signup and view all the answers

    Which type of accident has the lowest reported incidence among laboratory hazards?

    <p>Allergies</p> Signup and view all the answers

    What is a major consideration when developing new activities in the laboratory?

    <p>Performing an extensive risk assessment</p> Signup and view all the answers

    What must be emphasized to mitigate repetitive stress injuries in laboratory environments?

    <p>Ergonomic tools and practices</p> Signup and view all the answers

    Why is it important for the reception desk to be located close to the entry door in a laboratory?

    <p>To facilitate rapid patient registration</p> Signup and view all the answers

    Which factor contributes to the necessity of ongoing risk assessments in laboratories?

    <p>The dynamic nature of laboratory activities</p> Signup and view all the answers

    What is the recommended action for laboratory staff after an incident involving exposure to a hazard?

    <p>Inform supervisors and follow established procedures</p> Signup and view all the answers

    What is a necessary step when moving compressed gas cylinders in a laboratory?

    <p>The safety cap must be secured over the valve.</p> Signup and view all the answers

    What is the recommended method for recapping needles to ensure safety?

    <p>Hold one hand behind the needle and scoop the cap with the other hand.</p> Signup and view all the answers

    What type of container should sharps be disposed of in?

    <p>A puncture-resistant, leak-proof sharps container.</p> Signup and view all the answers

    Which of the following materials is NOT considered a sharp for disposal purposes?

    <p>Laboratory glassware</p> Signup and view all the answers

    What is the proper disposal method for contaminated laboratory glass?

    <p>Decontaminate it before disposal.</p> Signup and view all the answers

    What precaution should be taken when storing compressed gas cylinders?

    <p>They should be chained to the wall.</p> Signup and view all the answers

    What must be done to a sharps container that contains non-biohazardous sharps?

    <p>Deface any biohazard markings or symbols.</p> Signup and view all the answers

    Why is it important to label sharps containers clearly?

    <p>To inform custodial staff about the contents.</p> Signup and view all the answers

    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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    Laboratory Quality Management System Handbook (PDF)

    Description

    This quiz examines key aspects of a laboratory quality manual, including its purpose, organizational collaboration, and relevant international standards. Participants will also explore best practices for cleaning and safety responsibilities within laboratory settings. Test your knowledge on essential laboratory procedures and guidelines.

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