Activities related to Phase 1 - Facilities and Safety

  • Appoint a biosafety officer.

    Medical laboratories are potentially dangerous places to work due to chemical, electrical, mechanical, physical, but above all biological hazards. So it is important to always strive to minimize every risk in the laboratory. A method to achieve this is to develop procedures for safe behaviour. Examples are procedures for safe handling of samples, safety rules for personnel and visitors in the facility, safe handling of equipment, etc. The facility should also permit safe handling of microorganisms. But first the points for improvement in the laboratory need to be identified.

    The safety of the laboratory is not an item that part of a quality management system. ISO 15189 contains only one requirement on safety, merely stating that the laboratory must be safe and should comply with good practice and applicable requirements. However, in resource limited settings a lot of work has to be done to come in compliance with safety requirements. Therefore, this tool gives much attention in the first phase to the establishment of a safety improvement plan, based on a needs assessment.

    The first step in the safety improvement process is to appoint a Biosafety Officer. This person is responsible for all the topics related to safety and he/she will be the one planning and managing the safety improvement process. It is, off course, important that the Biosafety Officer receives the full commitment from the laboratory management in performing his/her work so that the Biosafety Officer is fully recognized by all the staff members and can perform his/her work with full cooperation from everybody.

    The biosafety officer has an advisory function to the management. Examples of tasks of the biosafety officer are (note that these are examples, more tasks may be added when needed):

    • Developing the safety policy and procedures (in consultation with the laboratory manager)
    • Ensuring staff compliance to safety policy and procedures by performing regular safety inspections, and documenting and submitting reports of such inspections to the laboratory manager
    • Orientating and training of all laboratory staff in biosafety
    • Providing safety advice
    • Investigating laboratory accidents and documenting accident/occurrence reports

    Specific task for the laboratory management: After appointing the biosafety officer explain to all staff members who the biosafety officer is and what his/her tasks are. It may also be good to make a “profile” of the position of the biosafety officer: a list of tasks and responsibilities that are specific for the biosafety officer so that he/she knows exactly what he/she should do.

    		  
  • Provide the biosafety officer with a biosafety training so that he/she is capable to fully perform his/her job tasks.

    To achieve a safe working environment, all staff members have to be trained in biosafety and safe behavior in a tuberculosis laboratory. The biosafety officer should naturally be an expert in biosafety. Therefore, begin with providing the newly appointed biosafety officer with this expertise by letting him/her participate in a biosafety training, in principle provided by a biosafety specialist. After this, the biosafety officer can provide the rest of the staff with biosafety education.

    In the course list several international courses in (tuberculosis) laboratory biosafety are included. The WHO/CDC/CLSI Laboratory Quality Management System Training Toolkit (LQMS) contains a module titled “Safety Management Program”. This provides more information on developing a laboratory safety program.

    		 * List of Courses
    *WHO/CDC/CLSI LQMS: Safety Management Program
  • Perform a facility and safety assessment.

    The facility and safety assessment could be seen as an audit of the basic facility and safety measures in place in the whole laboratory. To carry out this activity a checklist is provided. This checklist is adapted from the WHO laboratory biosafety manual (3rd edition). The complete manual is also provided for background information. The WHO LQMS also provides information of the safety management program.

    To identify the general risk level of your laboratory a matrix is provided at the beginning of this checklist. Based on the activities done at your lab you can identify whether your laboratory is a low risk, moderate risk or high risk facility. For each question of the checklist the risk level to which that question is applying is indicated. This means that a laboratory with a moderate risk level does not need to comply with checklist question of a high risk level.

    Complete this checklist. When a question is found that the laboratory is not complying with SMART action points should be formulated leading to the appropriate measures the make the laboratory complying with that specific question. For explanation on SMART action points see the next activity.

    Mind that it is not necessary to comply with the complete checklist at the end of this phase. Upgrading safety, and especially the facility can be a complicated process in low and middle income countries due to resource constraints. Since this situation is different for every country, maybe even for every laboratory, it is not possible to indicate in this implementation guide which safety measures should be in place in each implementation phase. It is however important that the laboratory perceives safety as a high priority element of quality. It is the responsibility of the laboratory supervisor to make sure the attention to upgrading safety is evenly spread over the four phases of the implementation guide, according to his/her own estimation regarding what is achievable. For example: if a mechanical ventilation system is required because high risk activities are performed at the laboratory, efforts may already have to start in phase 1 to raise funds, purchase and install such a system since this process may take much time. If the laboratory is only starting in phase 4 with this process it may be a disappointment if the final external audit for accreditation has to wait because only the mechanical ventilation system has not yet been installed.

    It is important that the laboratory complies with the appropriate safety and facility requirements when it is applying for accreditation in level 4.

    Performing the assessment is the responsibility of the biosafety officer. The laboratory supervisor is responsible for formulating the action points based on the outcome of the assessment and coordinate the execution of all action points. Especially the latter is important since only the laboratory supervisor has the authority to make sure that everybody completes the action points assigned to him/her. He/she should formulate action points to ensure compliance to the complete Facilities and Safety checklist.

    * Facility and Safety Assessment Checklist

    * WHO Laboratory Biosafety Manual

    *WHO/CDC/CLSI LQMS: Information on Safety Management
  • Formulate SMART action points for all activities that need to be taken in the laboratory.

    Implementing and maintaining a quality management system requires a lot of effort and activities from all personnel members (ranging from cleaning staff to top management). To prevent the accumulation of measures that are persistently not carried out the SMART model was developed. SMART stands for Specific, Measurable, Agreed, Realistic, Time-bound.

    This means that an activity that needs to be taken is formulated including:

    • A deadline on which the activity needs to be completed.
    • The person that needs to complete the activity.
    • A specific description of what needs to be done.
    • The date on which the action point was formulated

    When a specific activity leads to formulation of a set of action points, combine these action points in an action plan. For example: the safety checklist may lead to a high number of action points. Draft an action plan of the safety assessment combining all these action points in one matrix. See the generic action plan matrix to know what an action plan looks like. Provide the action points to all applicable staff members to guarantee that everybody is familiar with the open action points and especially to the ones assigned to him/her. When this is done for the first time explain to all staff members the principle of the SMART action points as explained here.

    Later, when work meetings will be organized on a regular basis (activity in phase 2) the action points will also be included in the minutes and discussed during each meeting.

    The laboratory manager if responsible for drafting action points and plans and coordinates their execution.

    *SMART Principles

    *Generic Action Plan
  • Write a biosafety manual and make sure it is read and signed by all staff.

    The term biosafety manual may cause some confusion since the WHO has also published a document called biosafety manual. However, in the WHO biosafety manual all the information on biosafety in a laboratory is given. The biosafety manual that should be written in this activity is another document. This manual is specific for the laboratory where it is written for. It describes the interpretation and how the biosafety requirements are implemented in the laboratory. All the biosafety procedures undertaken in the laboratory are described in this manual.

    This implementation guide provides a template biosafety manual. It is meant to show what a biosafety manual could look like. In this template the different chapters of the biosafety manual are standard operating procedures (SOPs), for each procedure one SOP was written.

    It is important that you (the biosafety officer) make your own biosafety manual since procedures are highly specific for each laboratory and are different for every laboratory. Therefore, the template biosafety manual cannot just be printed and used. You may use parts of it, use the structure to build your own, but be sure to adapt the procedures to as they really are carried out in your laboratory.

    For background information, refer to the WHO Laboratory Biosafety Manual.

    Add a Readingand understanding list to the biosafety manual. This is the instrument for proving reading and understanding by all staff members and indicates which staff members still have to read the document.

    All staff members have to read the complete biosafety manual and mark points for correction and/or improvement. When such suggestions are made, ask the staff to include their signature with the suggestion for correction/improvement, so that the author of the safety manual is able to track the maker of a correction/improvement in case he/she has questions.

    Template chapters of a laboratory biosafety manual are included in this implementation guide to give an idea of what a biosafety manual could look like. These chapters describe preventive and corrective safety procedures that can be adapted to the local situation (sources: the TB-CAP laboratory toolkit and NTRL Uganda biosafety manual). Since the chapters originate from two different sources, some chapters may be redundant. It is the responsibility of the biosafety officer and laboratory supervisor to identify safety procedures that are needed in the local situation. Mind that copy-pasting the template chapters of the template is useless because then the procedures are not refined to the local situation. Every laboratory is different, so are the procedures undertaken. It is thus highly important to go through all the template procedures to refine and adapt them to the local situation in your own laboratory.

    The template chapters provided are constructed as individual standard operating procedures (SOPs) with each chapter having its own version number. The advantage of this system is that, when one chapter needs to be revised, only the new version of this chapter needs to be printed and not the whole manual as would be the case if the manual in itself receives a version number and not the individual chapters. This saves money, paper (environment) and efforts.

    The table of contents of a laboratory biosafety manual could be as follows:

    • Title page
    • Introduction
    • Index
    • Procedure in case of spill of specimens in an AFB microscopy laboratory
    • Procedure in case of spill of infectious material within the biological safety cabinet
    • Emergency procedure in case of major biohazard incident outside the biological safety cabinet
    • Fumigation of the biological safety cabinet
    • Emergency procedure in case of fire
    • Use of personal protective equipment in an AFB microscopy laboratory
    • Use of personal protective equipment for culture and drug susceptibility testing
    • Use of disinfectants
    • Responsibilities of the biosafety officer and biosafety committee
    • General Safety Instructions
    • Universal Safety Precautions
    • Entry Rules to the Containment Laboratory
    • Introduction Checklist (for new employees)
    • Risk of Infection in case of Accident
    • Sputum Collection and Packaging
    • Specimen Handling and Safety
    • Avoiding the Dispersal of Infectious materials
    • Biological Safety Cabinets
    • Centrifuge Safety
    • Annual Communication of Safety Instructions
    • Waste Segregation and Disposal
    • Handling of Infectious Spills
    • Medical Examination and Health Control
    • Incident Report
    • Use of Pipette and Pipette Aids
    • Personal Protective Equipment
    • Risk Assessment and Scope
    • Ultraviolet Light Safety
    • Electricity Safety
    • Compressed Liquefied Gases Safety

    * WHO laboratory biosafety manual

    * Generic reading and understanding list

    *Procedure in case of spill of specimens in an AFB microscopy laboratory

    *Procedure in case of spill of infectious material within the biological safety cabinet

    *Emergency procedure in case of major biohazard incident outside the biological safety cabinet

    *Fumigation of the biological safety cabinet

    *Emergency procedure in case of fire

    *Use of personal protective equipment in an AFB microscopy laboratory

    *Use of personal protective equipment for culture and drug susceptibility testing

    *Use of disinfectants

    *Responsibilities of the biosafety officer and biosafety committee

    *General Safety Instructions

    *Universal Safety Precautions

    *Entry Rules to the Containment Laboratory

    *Introduction Checklist (for new employees)

    *Risk of Infection in case of Accident

    *Sputum Collection and Packaging

    *Specimen Handling and Safety

    *Avoiding the Dispersal of Infectious materials

    *Biological Safety Cabinets

    *Centrifuge Safety

    *Annual Communication of Safety Instructions

    *Waste Segregation and Disposal

    *Handling of Infectious Spills

    *Medical Examination and Health Control

    *Incident Report

    *Use of Pipette and Pipette Aids

    *Personal Protective Equipment

    *Risk Assessment and Scope

    *Ultraviolet Light Safety

    *Electricity Safety

    * Hazardous Chemical Precautions

    *Compressed Liquefied Gases Safety

    * Fire Safety
  • Inform the laboratory staff so they become aware of symptoms of TB and facilitate access to diagnostic and medical services for TB, if needed.

    Discuss the symptoms of TB, and how-to-recognize TB, during a work meeting. This information should also be included in the biosafety manual.

    Ensure that a mechanism is in place to ensure that laboratory staff has access to diagnostic and medical services (including financial assistance if necessary) in case staff members show symptoms of TB.

    This activity should be carried out by the laboratory supervisor in combination with the biosafety officer.

    * CDC: General Information on TB