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

Section 2 Risk assessment (pages 5 -26)

The title to this section was simplified to Risk Assessment in the WHO LSM 4th edition, by removing the word “biological”. This section has been enhanced to include considerations and examples for the different stages of the assessment. Each subsection reflects the steps included in the risk assessment framework.

2.1 Gather Information
This section addresses the step for gathering information by providing examples of key questions to ask in general, and when facing new or unknown biological agents.

2.2 Evaluate the risk
This section provides factors associated with the likelihood of an incident occurring, and factors that affect the consequences of an incident if it were to occur. This subsection presents the risk assessment matrix (Table 2.5) followed by establishing if the risks are acceptable.

2.3 Develop a risk control strategy
This section discusses developing a risk control strategy, it provides examples of risk control strategies, and strategies for risk reduction.

2.4 Select and implement risk control measures
This section provides considerations required for the selection and implementation of control measures. A tool for evaluating these factors and elements is provided in Table 2.7 which lists the procedure, the initial risk, the risk control measure, and the residual risk.

2.5 Review risks and risk control measures
The last subsection addresses continuous review of risks and risk control measures. Importantly, it provides a list of examples when the risk assessment should be updated as part of the continuous improvement.

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Section 3 Core requirements (pages 27-48)

In the 4^th edition, the authors took elements from each section in the 3^rd edition that pertained to best and minimal practices for working in clinical and diagnostic laboratories and combined them in this new Section 3- Core requirements.

This section included operation and physical elements that when combined ensures safe handling of the agents, and a safe working environment in clinical and diagnostic laboratories and must be part of the overall biosafety program management (described in Section 7) . Additional requirements necessary for agents requiring maximum containment are described in Sections 4 and 5.

3.1 Good Microbiological Practice and Procedure (GMPP)
GMPP is a term given for standard operating practices and procedures or a code of practice when working with biological agents. GMPP are essential in the control of laboratory acquired infections. This section goes on to describe the different elements of GMPP. This section includes best practices (behaviors to be followed to ensure a safe work environment), technical procedures (elements to consider for controlling the risk of exposure and cross contaminations)

3.2 Personal Competence and Training
This section enforces the importance of proper staff training including a table outlining the training that should be implemented for laboratory workers. The importance of staff understanding the guidelines and documentation. This section also mentioned the need for financial and administration support from laboratory management to enable the process.

3.3 Facility Design
This section list requirements a facility should meet for safe work and handling of biological agents. These include the type of finishing the laboratory should have (floor, walls, cabinetry, work surface), storage needed for supplies and samples, lighting and ventilation requirements, reliable electricity sources, emergency equipment (first aid), external threats from weather, geographical, fire, floods.

3.4 Specimen Receipt and Storage
This section covers the core requirements to minimize risk when receiving, storing, and inactivating specimens. Preparation of samples for transport and transfer is covered in Section 6. This section includes receiving specimens (core requirements that should be considered when receiving specimens such as ensure documentation is sufficient for the laboratory worker to be able to identify the specimens know what the potential hazard and test are needed), storage of specimens (specifications that  storage containers should meet), inactivation (enforces the importance of having validated inactivation procedures before transferring samples to other area for manipulation).

3.5 Decontamination and waste management.
It is a core requirement of biosafety management programs to have processes in place for identification, segregation of contaminated material prior to decontamination/disposal.

When material cannot be decontaminated on site it must be properly packaged for transportation further information on transportation can be found in section 6.

Table 3.2 provides guidance on segregation and treatment of contaminated material.

This section also covers the criticality of having validated procedures of decontamination methods and consideration needs to be taken for non-biological material that may be contaminated such as work surfaces, sharps. This section goes on to describe the more common methods of decontamination used by laboratories. The Chemical Disinfection section includes information on when chemical disinfection can be applicable are given, including information on pre-cleaning for heavily soiled material as elements that will influence the chemical disinfection procedures. The section on Autoclaving covers the general principles of autoclaving. It describes the autoclaving process and elements to consider when preparing material for autoclaving. The section on Incineration describes how this is an alternative method of decontamination and serves as a disposal method. Additional information can be found in the monograph: decontamination and waste management (22).

3.6 Personal Protective Equipment
This section covers the different types of Personal Protective Equipment (PPE) commonly used in the laboratory.  It covers the importance of seize and brand used to ensure best protection to the user. PPE described in this section includes laboratory coat, footwear, gloves, eye protection, and respiratory protection. Additional information about PPE can be found in the monograph: Personal Protective Equipment (20).

3.7 Laboratory equipment
In this section the importance of proper use of laboratory equipment and GMPP is covered to ensure a safe work environment.  Core elements are presented when considering the selection operation and maintenance of laboratory equipment. These include but are not limited to a budget for maintenance and service, equipment inventories, proper training of staff, appropriate facilities for the equipment. Consideration regarding routine and emergency decontamination and proper use of the equipment to include SOP, authorized users are also included in this section. Best practices are included for using specialized equipment such as centrifuges and pipettes.

3.8 Emergency/incident response
In this section information developing incidence response plans for all type of possible incidences that could occur in the laboratory as well as key elements that should be included such as individuals to contact, location of emergency response kits, procedures to follow and training of personnel. The subsection on biological spills provides a general procedure to follow in the case of a biological spill and elements to consider in the response. Additional information can be found in the monograph: decontamination and waste management (22).

3.9 Occupational Health
This section provides and overview of the role of an occupational health program in ensuring the health of laboratory worker, through prevention and when needed monitoring of employee health. Additional information can be found Monograph: biosafety program management (17).