WHY
The core principle of quality management is: "Document your actions and follow your documentation." This implies the necessity to record all routine activities conducted in the laboratory. Consequently, each test and process should be detailed in Standard Operating Procedures (SOPs). SOPs ensure consistent and optimal execution of tasks, reducing the likelihood of errors, incidents, and inaccurate outcomes. In terms of safety protocols, they mitigate risks of accidents, infections, and pathogen transmission. All safety measures within the laboratory must be meticulously documented.
WHAT
A comprehensive Biosafety Manual needs to be formulated, encompassing all safety protocols within the laboratory. Safety procedures are categorized as preventive, concurrent, and corrective:
Preventive: Precautions and protocols designed to avert accidents, lab-acquired infections, and pathogen dissemination.
Concurrent: These procedures outline the best approach to address incidents like spills or fires, minimizing the risk of exacerbating the situation.
Corrective: Following an incident, these protocols identify the root cause and implement preventive measures to prevent recurrence.
It is imperative for all individuals to familiarize themselves with the Biosafety Manual to ensure proper execution of procedures. The manual's chapters will mirror the structure of Procedure SOPs. Below is a sample list of potential topics for inclusion in the biosafety manual. Note that this list serves as a starting point; feel free to suggest additional relevant topics and exclude those not applicable to your laboratory's context.
Title Page
Table of Contents
Introduction
Responsibilities of the Biosafety Officer
General Safety Instructions & Precautions
Risk Assessment and Scope
Introduction Checklist (for new employees)
Annual Communication of Safety Instructions
Medical Examination and Health Control
Entry Rules to the Containment Laboratory
Personal Protective Equipment
Use of Disinfectants
Specimen Handling and Safety
Avoiding the Dispersal of Infectious Materials
Use of Pipette and Pipette Aids
Biological Safety Cabinets
Centrifuge Safety
Electricity Safety
Waste Segregation and Disposal
Emergency Procedure in Case of Fire
Procedure in Case of Spill of Infectious Material in the Laboratory
Procedure in Case of Spill of Infectious Material
Emergency Procedure in Case of Major Biohazard Incident
Risk of Infection in Case of Accidents
Incident Report
HOW & WHO
Biosafety Officer:
Create a list of necessary safety procedures for your lab.
Discuss it with the Lab Manager and staff to ensure completeness.
Develop chapters based on this list, with each chapter representing a safety procedure (Procedure SOP).
Have the Lab Manager and another senior staff member review your work.
Revise procedures based on their feedback.
Sign off on procedures upon completion, with both reviewers also signing.
These procedures collectively form the Biosafety Manual, which should be presented to all staff members along with an explanation of its use.
Lab Manager:
Review the topics outlined in the biosafety manual (created by the Biosafety Officer) with the Officer and staff to confirm completeness.
Respond promptly to requests from the Biosafety Officer for reviewing biosafety procedures.
Ensure another senior staff member reviews the procedures as well.
Include all procedures in the Read and Understand List once authorized.
Present each procedure at weekly staff meetings for all staff to review and sign the Read and Understand List.
Prior to new hires, ensure they read the Biosafety Manual before commencing work in the lab.
For more information, please visit the link:
https://extranet.who.int/lqsi/