Summary of Changes to the World Health Organization Laboratory Biosafety Manual 4th Edition

This Summary of Changes was prepared by the ABSA International Technical and Regulatory Review Committee (TRR) in collaboration with the International Relations Committee. April 2022

This Summary of Changes is not to be used as a substitute for the WHO Laboratory Biosafety Manual 4th Edition.

Table of Contents

Monographs
–Risk assessment
–Laboratory design and maintenance
–Biological safety cabinets and other primary containment devices
–Personal protective equipment
–Decontamination and waste management
–Biosafety Programme Management
–Outbreak preparedness and resilience

Monographs

This monograph is designed to accompany the WHO LSM 4th Edition. This monograph contains additional details, examples and scenarios for conducting risk assessments in support of the risk- and evidence- approach to biosafety and biosecurity intended by the WHO LSM 4th edition.

This monograph is divided in four sections:

  • Section 1 introduces the monograph, scope and how to use the monograph.
  • Section 2 provides information on considerations to form the risk assessment team and completing the assessment.
  • Section 3 provides the application of the 5-step process presented in the manual and in section 2 of the monograph using real-life examples of events occurring in biological laboratories and examples of ways to modify experiments to decrease risks.
  • Section 4 provides case-scenarios where risk assessments are conducted, it includes scenarios such as a lab-acquired infection, a near-miss and situation involving an laboratorian’s health status.

This monograph also includes several Annexes:

  • Annex 1 is an abbreviated template for risk assessment using the 5-step process.
  • Annex 2 is the long form for conducting a risk assessment using the 5-step process. This template includes considerations and questions to ask in bullet-point format for each step.
  • Annex 3 and Annex 4 provide two completed risk assessments using the short form provided in Annex 1; Annex 5 and Annex 6 provide two completed risk assessments using the long form provided in Annex 2.

Laboratory Design and Maintenance is one of the monographs for the fourth edition of the World Health Organization (WHO) Laboratory Biosafety manual (core document). This monograph contains 10 sections. The sections 1-4 cover design considerations for different levels of laboratories. Design features for core requirement laboratories must be incorporated in all laboratories. Additional risk control measures, design features or modifications are necessary for laboratories where a risk assessment has determined that heightened control measures or maximum containment measures are required to maintain a safe working environment. The sections 1-4 also emphasize the importance of the risk assessment and needs assessment in considerations of design features. 

The sections 5-10 cover the different phases of laboratory design and operation, including planning, design, construction, operation, and maintenance, as well as decommissioning of laboratory facilities.  These sections expand and illustrate the steps and stages in the framework at each main stage. Some important elements require careful attention, especially budgets, personnel, and schedules. Before the construction, repurposing or renovation process can begin, a detailed risk assessment must be carried out to determine the specific risk control measures that need to be implemented. In addition, a facility-specific needs assessment is required to define all other design features needed for the laboratory.

Each section between 6-9 contains a project flowchart according to the corresponding phase, from planning to operation and maintenance. The end of this monograph has two annexes with titles “Examples of a user requirement brief” and “Examples of a user requirement specification”.

The monograph adopts a risk- and evidence-based approach to biosafety ensure that laboratory facilities, safety equipment and work practices are not only proportionate to needs but also sustainable. The risk- and evidence-based approach aims to facilitate laboratory design and ways of operating that ensure greater sustainability while maintaining adequate and appropriate control of biosafety.

The people who are involved in any stage of the laboratory design and operation are the targeted readership for this monograph, including senior management, laboratory manager, biosafety officer, architects, designers, construction engineers and builders.

Biological safety cabinets and other primary containment devices are presented as a subject-specific monograph with WHO Laboratory Biosafety Manual (LBM) 4th edition. It was under part III laboratory equipment’s in section 10 and 11 (18 pages document) in WHO LBM 3rd edition.

This monograph explains the different types of BSC and other primary containment devices and the best practice for working with these devices. The technical features of primary containment devices, such as directional airflow, are explained and methods for their decontamination are discussed. The information in this monograph on biological safety cabinets and other primary containment devices is designed to accompany and support the fourth edition of the WHO Laboratory biosafety manual (core document) and other associated monographs. The manual and the monographs adopt a risk- and evidence-based approach to biosafety rather than a prescriptive approach to ensure that laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and sustainable. This is a new approach facilitate the importance of a sustainable safety culture with adequate and appropriate control of biosafety.

Section 1 provides a detailed description of Biosafety cabinets, isolators and Ooher local exhaust ventilation devices are provided in the introductory session.

Section 2 describes how to use the primary containment. The topics included are, best practice for working with open-fronted devices and additional considerations while working with enclosed devices.

A detailed description of decontamination of safety cabinets and isolators including liquid and vapor decontamination are also included in this section.

Section 3 describes the direction of airflow. The topics included are high efficiency particulate air filtration, direct recirculation, hard ducting, and anti-blowback valves.

Section 4 provides the selection process of a primary containment device. A summary table for reference of the selection process is provided in this section. A detailed working mechanism of BSCs with illustrations and summary table is also provided. This section also provides a working mechanism of containment isolators with other local exhaust ventilation types.

The PPE recommendations while using the BSC’s were provided in the other associated monograph titled “personal protective equipment”.

This monograph was not present in the WHO Laboratory Biosafety Manual 3rd edition. This covers in more detail information provided in section 11 of the 3rd edition. Personal Protective Equipment (PPE) is discussed in all sections of the current edition; however, the information is general and broad to that section.

In this monograph each type of PPE, (e.g. gloves, respirators, gowns, lab coat, eye protection, foot protection) is presented in detail.

The preface provides a glossary of terms

Section 1 provides a generic presentation of the document including the principles of selection and use of PPE. This section also includes national and international standards and regulations on PPE.

Section 2 provides information needed to appropriately select PPE based on the work conducted and risk assessment, agent used, availability of PPE, type of work, additional hazards present, combination of PPE, and user feedback.

Section 3 provides the definitions of the core requirement, the suggestion of PPE core requirements and the description of GMPP.

Section 4 This section explains how PPE are used for heightened control measures and additional PPE may be required alternatively as part of the risk control. PPE described here include lab coats, aprons, gown, coveralls, footwear, eyer protection, and respiratory protection

Section 5 This section gives a fundamental introduction to facilities that bring the highest level of protection and specification on PPE needed in different containments levels including cabinet line facilities and positive-pressure suits.

Section 6 This section starts with general information about protective garments Reference to ISO standards are made and table 6.1 provides guidance on the type of protective clothing and use. Details are provided for pre-checks, donning and doffing of protective clothing.

Section 7 provides a description of appropriate laboratory footwear. Considerations to take in account when selecting appropriate footwear based on the work conducted and environment. Footwear must offer protection to the user against potential exposures including chemicals and prevent slips and falls. They also must be comfortable and of the appropriate seize for example.

Section 8 provides a general description of “why” gloves are used, sizing and different material available. It continues in more detail about the different type of gloves available, covers the protection factors of gloves and reusable gloves that may be used for other laboratory hazards such as heat/cold protection, cut-resistant or puncture-resistance gloves. Consideration for limitation in dexterity and need for training is covered as well. Pre-check, donning and doffing techniques are presented.

Section 9 This section covers the use of eye protection against splashed and particles as well as UV light. In this section information about the specification eye protection must meet are provided. How to properly put on and use eye protection is describes as well as how to properly remove eye protection. A figure 9.1 illustrates donning and doffing.

Section 10 This section covers the different type of respiratory protection worn in laboratory settings.  A general overview of respiratory protection is provided including when these can be used based on risk assessment.

Section 11 In this section information is provided about the type of head cover that can be used in the laboratory, the importance of properly tying back hair to prevent hand to head contact and the possibility of combining head cover with respiratory protection. The determination and selection of the appropriate head cover should be based on a risk assessment.

Section 12 is specific to hand hygiene. This section covers the importance of proper hand hygiene and the best practices to follow. Figure 12.1. describes proper hand washing and drying.

Section 13 covers cleaning, maintenance and disposal of PPE based on the type used. This section covers information on cleaning and disinfecting of reusable PPE, the maintenance and storage of PPE to ensure proper functioning, covers the maintenance and storage of reusable and disposable laboratory coats, and other practices for PPE maintenance.

Section 14 covers standards and regulations around the use of PPE. This section describes a set of principles intended for PPE to ensure that a minimum level of protection is achieved, that PPE is selected and used correctly as well as providing examples of standards.

This monograph provides more specific information regarding decontamination and waste than is found in the LBM as it builds off of the generalities found within.  The monograph is broken into 4 sections, each containing a small number of subsections.

Section 1: Introduction

Section 2: Methods of decontamination with 6 subsections, each containing a specified method of decontamination.  The methods of decontamination described are broken down and categorized.  For example, Chemical methods of decontamination are further broken into gas/vapor or liquid categories.  From there each one, such as “peroxides” is explained in detail.

Section 3: Waste Management and decontamination of waste products with 3 subsections.

As with the previous chapter, each type of waste is broken down into a category, such as biological, sharp, or chemical.  From there the categories are further delineated.  Important for each local is to know and understand the regulatory complexities of your site.

Section 4: Methods of Inactivation with subsections. Inactivation is provided in terms of methods such as nucleic acid extraction, formalin treatment, thermal inactivation, and ionizing radiation.  

 The information provided can be used to assist lab personnel in developing site-specific procedures for biological wastes.

This Monograph is divided in five sections, namely Introduction, Management Cycle, Biosafety Culture, Roles and responsibilities and, Developing a Biosafety Programme.

Section 1: A biosafety programme is a collection of information and associated actions that include: an institutional policy to describe the scope, purpose, and objectives of the biosafety programme.

The information in this monograph on biosafety programme management is designed to accompany and support the fourth edition of the WHO Laboratory biosafety manual (core document) and other associated monographs.

The manual and the monographs adopt a risk- and evidence-based approach to biosafety rather than a prescriptive approach to ensure that laboratory facilities, safety equipment and work practices are locally relevant, proportionate to needs and sustainable.

Section 2: Management cycle

Effective management of a biosafety programme can be achieved by implementing the following project management cycle: planning – assessment – implementation – review and improvement (PDCA). The four stages of the cycle should be carried out in all types of facilities.

Section 3: Biosafety Culture

A biosafety culture is not easily achieved. It requires factors such as

  • time,
  • clearly defined roles and responsibilities within the organization;
  • a biosafety manual that outlines risk control measures for the risks associated with biological hazards; and comprehensive procedures to support the safety policy.
  • commitment and diligence from all personnel, supervisors and senior management, in an environment of respect and trust.
  • early consultation with and cooperation between those responsible for the development of a biosafety programme and those directly affected by or working within this programme will support a successful working relationship where the common goal of biosafety is achieved.

Section 4: Roles and Responsibilities

  • The subsections describe the key roles and responsibilities of institutional personnel in the development and maintenance of the organization’s biosafety programme.
  • Depending on the size and complexity of the organization, roles and responsibilities may overlap.
  • For example, in a smaller facility, the laboratory director may also be a member of the organization’s senior management team, and the responsibilities of the biosafety officer may be performed by laboratory personnel (quality manager) or amalgamated with other aspects of safety (such as chemical, ergonomic, electrical) in the role of an overarching safety officer.

Section 5: Developing a Biosafety Programme

  • Regardless of the size and complexity of the organization, the foundational elements of a biosafety programme remain the same.
  • All stages of the biosafety programme management cycle (planning, assessment, implementation, and review and improvement) should be carried out in all facility types, and the elements associated with each phase should be defined and represented.
  • What these elements look like and how they are implemented will vary between organizations, facilities and individual laboratories.

This monograph addresses preparedness for global outbreaks including new and unknown pathogens. It is intended to be used in the context of risk- and evidence-based decision making. It also draws recommendations and lessons learned from the early stages of recent outbreaks such as Ebola and SARS-CoV-2.

This monograph starts with a glossary section that sets the stage for the considerations provided in the following sections:

Section 1 describes in detail the stages of an outbreak.

Section 2 applies the 5-step process for risk assessment when planning for outbreaks.

Section 3 provides considerations for adapting facilities in preparation for an outbreak, including graphs with red, amber and green zones and traffic flows. It also describes the use of mobile laboratories, how to integrate laboratories during the planning process and the importance of involving key stakeholders. Lastly, it discusses the use of laboratory equipment during outbreaks.

Section 4 discusses personnel to be involved in the response to an outbreak. This section also provides considerations for recruiting, training, assessing competency, requirements for deployment if an outbreak were to occur.

Section 5 is about PPE considerations from the planning perspective, what PPE could be needed, standards to be maintained and disposal of used PPE, to name a few.

Section 6 describes workflows and spaces that need to be adapted during outbreaks. This section has illustrations to show different arrangements for diagnostic laboratories and has tables with suggestions for collection of patient data. Considerations are provided for sample inactivation and the engineering controls, PPE, and practices that should be assessed. This section also provides details on decontamination and waste management, including the use and maintenance of the autoclave, if available.

Section 7 describes specimen transfer and transport considering that samples during an outbreak may not be done as for known substances.

Section 8 describes accident and incident response when handling samples during an outbreak. Examples of incident responses are provided.

Section 9 provides stressor factors to consider when personnel are responding to an outbreak. Occupational health and medical response considerations for before, during, and follow-up after the response to the outbreak.are provided to ensure a comprehensive support to laboratory workers.

Section 10 provides considerations for ensuring laboratory biosecurity regarding specimen handling. Section 11 describes the practices and consideration when the outbreak or epidemic has been contained and cases are decreasing. These considerations include communications to stakeholders, lessons learned, strategies to continue providing services, and potential laboratory decommissioning and questions to ask regarding the specimens in hand.