Laboratory Quality Manual Overview

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Questions and Answers

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 (D)</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 (D)</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 (D)</p> Signup and view all the answers

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

<p>Floors (C)</p> Signup and view all the answers

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

<p>Weekly (C)</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 (D)</p> Signup and view all the answers

Who is often responsible for developing a laboratory safety programme?

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

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

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

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

<p>Once a month (B)</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 (D)</p> Signup and view all the answers

What is the first phase in the laboratory process?

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

Which phase follows the sample collection in laboratory procedures?

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

What is the ultimate goal of laboratory quality management?

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

During which phase are lab results interpreted?

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

What does the complexity of the laboratory system demand?

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

What is a key component of the laboratory examination phase?

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

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

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

What happens after report creation in the laboratory process?

<p>Report transport (B)</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 (C)</p> Signup and view all the answers

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

<p>Local and national disposal regulations (D)</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 (C)</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 (A)</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 (A)</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 (A)</p> Signup and view all the answers

Which type of flooring is recommended in a laboratory?

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

Why should wood not be used for laboratory work benches?

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

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

<p>32% (A)</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 (B)</p> Signup and view all the answers

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

<p>Repetitive stress (D)</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. (D)</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 (D)</p> Signup and view all the answers

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

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

What is the major source of contamination in diagnostic laboratories?

<p>Aerosols (C)</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 (C)</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 (A)</p> Signup and view all the answers

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

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

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

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

What type of inoculation is associated with murine typhus infection?

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

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

<p>Coxsackie virus infection (D)</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. (B)</p> Signup and view all the answers

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

<p>Pre-examination phase (D)</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. (D)</p> Signup and view all the answers

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

<p>Diagnostic (A)</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 (D)</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 (D)</p> Signup and view all the answers

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

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

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

<p>WHO, CDC, and CLSI (A)</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 (C)</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 (A)</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 (C)</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 (A)</p> Signup and view all the answers

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

<p>WHO Lyon Office (D)</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 (D)</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 (B)</p> Signup and view all the answers

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

<p>Integration of international laboratory standards (B)</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 (A)</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 (C)</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 (B)</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 (C)</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 (C)</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 (A)</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 (A)</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 (D)</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 (A)</p> Signup and view all the answers

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

<p>Laceration (D)</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 (D)</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 (B)</p> Signup and view all the answers

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

<p>They help identify potential risks (B)</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 (A)</p> Signup and view all the answers

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

<p>Allergies (B)</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 (D)</p> Signup and view all the answers

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

<p>Ergonomic tools and practices (B)</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 (C)</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 (D)</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 (C)</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. (B)</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. (D)</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. (C)</p> Signup and view all the answers

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

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

What is the proper disposal method for contaminated laboratory glass?

<p>Decontaminate it before disposal. (A)</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. (D)</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. (A)</p> Signup and view all the answers

Why is it important to label sharps containers clearly?

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

Flashcards

Sample Collection

The process where a blood or tissue sample is taken from a patient for analysis in a laboratory.

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

The phase where the sample is analyzed in the laboratory using various techniques and equipment.

Result Interpretation

The process of reviewing and interpreting the results of laboratory analysis to determine the significance and implications for the patient.

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Report Creation

The phase where the findings of the laboratory analysis are compiled into a comprehensive report that communicates the results and their meaning.

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Report Transport

The process of transmitting the completed laboratory report from the lab to the requesting healthcare provider or the patient.

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Pre-Examination

The phase where the patient is evaluated before laboratory testing to determine the appropriate tests and procedures.

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Quality Management

Ensuring accuracy, reliability, and validity of laboratory tests by implementing quality control measures and procedures.

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Liquid Waste Management

Designing and implementing a safe and effective system for managing liquid waste generated from lab equipment and procedures.

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Emergency Generator

A backup power source that provides electricity when the primary source fails.

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Stable Power Supply

The ability of a laboratory to maintain a stable and continuous supply of electricity.

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Disinfection

The process of removing or killing harmful microorganisms from surfaces and equipment.

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Durable Benchtop

A laboratory benchtop made of a material that is resistant to chemicals, easy to clean, and durable.

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Ceramic Tiles

A material commonly used for benchtops due to its durability, ease of cleaning, and resistance to chemicals.

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Wood

A material that should not be used for lab benchtops due to its tendency to harbor contaminants and deteriorate under harsh conditions.

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Steel

A material that is not recommended for lab benchtops due to its susceptibility to rust when exposed to chlorine-based disinfectants.

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Work bench organization

Organizing work areas based on the specific analysis type with enough space for equipment, SOPs, and job aids.

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Microbiology work bench separation

Separating work areas in microbiology labs according to the types of samples or pathogens to minimize cross-contamination.

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Laboratory cleaning schedule

Regular cleaning and disinfection of lab areas, including benchtops, floors, ceilings, walls, refrigerators, and storage areas, based on frequency requirements.

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Benchtop cleaning and disinfection

Daily cleaning and disinfection of benchtops after completing examinations and spills, typically done by laboratory technicians.

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Floor cleaning

Cleaning and disinfecting floors, often by cleaning staff, unless lab access restrictions require technicians to do it.

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Cleaning and disinfection record

A documented record of cleaning and disinfection activities, including the date and person performing the maintenance.

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Laboratory safety programme

A plan outlining safety procedures and measures for the laboratory, often developed by a dedicated safety officer.

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Laboratory safety officer

The individual responsible for developing and implementing the laboratory safety program, often a dedicated officer or the lab manager.

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Risk assessment in labs

The process of identifying and evaluating potential hazards in the lab environment to protect workers.

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Lab safety procedures

Safety procedures that outline what to do in case of accidents, injuries, or contamination.

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Recording lab safety incidents

Keeping records of staff exposures to hazards, actions taken, and measures to prevent future incidents.

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Physical risks in labs

Physical hazards that can cause injury to lab workers, including cuts, bruises, and strains.

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Lab-acquired infections

The risk of contracting an infection while working in a lab, especially with infectious materials.

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Safety training for lab equipment

Training in specific safety procedures for using lab equipment, preventing accidents, and protecting workers.

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Why lab safety matters

The importance of safety procedures to prevent accidents and ensure a safe lab environment.

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Lab director's safety role

The responsibility of the laboratory director to manage and reduce risks to lab workers.

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Aerosol Transmission

The spread of tiny particles in the air that can contain infectious agents, like bacteria or viruses.

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Physical Containment Level 2 Lab

A laboratory designed to handle potentially dangerous biological agents with strict safety measures.

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Containment System

A system that prevents the spread of aerosols within a laboratory.

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Inward Airflow

The flow of air into a laboratory to prevent the escape of potentially hazardous materials.

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Absolute Filtration

A specific type of filter that removes almost all particles, including those that can carry pathogens.

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Personal Protective Equipment (PPE)

The process of using protective equipment to prevent exposure to hazardous substances.

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Percutaneous Inoculation

The risk of infection through a puncture wound.

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Mucous Membrane Contact

The risk of infection through contact between mucous membranes and contaminated material.

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Laboratory Quality Management System

Developing and implementing a plan to ensure accuracy, reliability, and validity of laboratory testing. This involves establishing quality control measures and procedures.

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Laboratory Quality Manual

A comprehensive document outlining the laboratory's quality management system, including procedures, policies, and responsibilities.

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Implementation

The process of putting laboratory quality plans into action.

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Organizational functions

Implementing the quality management system's requirements, ensuring the lab operates effectively and efficiently.

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Handbook Development

A collaborative effort involving WHO, CDC, and CLSI to develop a comprehensive guide for laboratory quality management.

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Laboratory Quality Management

The process of ensuring the reliability and accuracy of laboratory tests through quality control measures and procedures.

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Importance of Laboratory Quality

The importance of laboratory quality in ensuring accurate and reliable test results, leading to better patient care and decision-making.

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History of Laboratory Quality Management

The history and evolution of quality management practices in laboratories, highlighting advancements and challenges.

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Quality Management System Model

A model illustrating the components of a quality management system, such as planning, implementation, monitoring, and improvement.

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Laboratory Quality Management System (LQMS)

A system that ensures the accuracy, reliability, and validity of laboratory testing through quality control and procedures.

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Laboratory Quality Management System Handbook

A document that provides a comprehensive reference on LQM for laboratory stakeholders.

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Achieving Quality in Laboratories

The process of establishing, maintaining, and improving the accuracy, timeliness, and reliability of laboratory testing.

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Trustworthy Lab Results

The ability of a laboratory to produce test results that are trusted by the international community, especially during emergencies.

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Path of Workflow

The entire process of testing, encompassing everything from sample collection to result interpretation and reporting.

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Examination

The actual laboratory analysis of the collected samples using various techniques and equipment.

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Laboratory Design: Patient and Sample Pathways

Designing and organizing workflows to minimize contact between patients and biological materials, ensuring patient samples have separate pathways from patients and the general public.

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Needles and sharps disposal

The process of handling and disposing of needles, broken glass, and other sharps to prevent infection of lab and cleaning staff.

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Sharps container

A container designed to safely hold sharps like needles and broken glass, preventing punctures and leaks.

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Safe needle recapping

A method for recapping needles where the person keeps one hand behind the needle and uses the other hand to scoop the cover onto the needle, minimizing the risk of accidental needle sticks.

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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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