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Only laboratory staff must have access to the laboratory facilities. Therefore a system must be installed that continuously inhibits access by unauthorized personnel. The reason for this is twofold: one wants to keep out persons that could steal or damage the laboratory equipment and information. The second reason is that unauthorized persons (not familiar with safety rules) need to be protected so that they cannot harm themselves in the laboratory. As is logical, the TB laboratory staff should be authorized to access laboratory facilities. Examples of possible systems: a code-lock (that is regularly changed), a fingerprint system, etc. Authorized personnel only signs indicate that the area has restricted access. The same applies to storage areas. This activities should be carried out by the biosafety officer in conjunction with the laboratory supervisor. |
Activities related to Phase 2 - Facilities and Safety
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Processing areas should be separated if conflicting activities are performed. Examples:
- Primary sample collection area should be separated from the laboratory. Ensure that this area allows proper sample collection with regard to risk for tuberculosis spread (no increased infection risk for staff). Also include patient comfort in designing this area (e.g. presence of chairs, protection from direct sunlight and rain, etc.). In phase 3 more attention is paid to design of primary sample collection areas.
- Culture is performed in a separate room. DST should be performed in a closed-off area to minimize the risk of infection.
- A unidirectional workflow is in place for molecular work to prevent cross contamination (e.g. in the PCR laboratory an entry door and an exit door shall be used and different areas for different steps in the process). For more information refer to a job aid developed by the course Strengthening Laboratory Management towards Accreditation (SLMTA) titled Guiding Principles for Workstation Set-up.
- A separate room for cleaning of laboratory glassware and tools.
It may be necessary to have a look at the efficiency of movements through the laboratory (does the floor plan of the laboratory allow an efficient workflow (unidirectional) through the laboratory or does the technician frequently has to cross the laboratory for different activities with the risk of bumping into a colleague causing a spill?). The SLMTA course contains a protocol for developing a most efficient floor plan to assist you in designing the most efficient floor plan. In addition, the World Health Organization (WHO) training toolkit “Laboratory Quality Management System” (LQMS) contains and information sheet on laboratory design that could also be of assistance.
SLMTA: Guiding Principles for Workstation Set-up -
Personnel working in the laboratory should be able to communicate messages to people outside the laboratory without leaving the laboratory. One could think of an intercom system or a telephone system (in case the communication system should link to other buildings; make sure the telephone numbers are available in the laboratory).
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In case of interruption of electricity supply, a backup generator should be in place.
An uninterruptible power supply (UPS) may be necessary to ensure continuous supply of electricity to essential pieces of equipment.
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A directional airflow in a laboratory without a negative pressure system is important to make sure that the air is not flowing in the direction of the workbench (whereby the bacteria are blown towards the technician).
Install a system that visualizes this airflow to ensure a safe directional flow. This can be as simple as attaching a slice of paper near the workbench that clearly shows which way the air is flowing.
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An hazardous materials register should be made to obtain insight in the amount and location of all hazardous materials within the facility. This also serves to determine (in a later phase) which safety measures should be in place for correct storage of these materials (e.g. flammable liquids shall be stored in a flammable-liquids cabinet, poisonous/acids/alkaline liquids shall be stored in a spill containment cabinet, etc.).
Collect Material Safety Data Sheets (MSDS) of each hazardous material present in the laboratory (two examples attached). These are often included in the packages received from the supplier. Store these in a file called Hazardous Material Inventory together with the hazardous materials register. The biosafety officer must keep this file up to date and include MSDS when new hazardous materials are purchased.
To ensure adequate and proper storage space for hazardous materials, the Strengthening Laboratory Management towards Accreditation (SLMTA course) job aid for identification of adequate and proper storage space could be used.
Generic Hazardous Material Register
SLMTA Job Aid for Identification of Adequate and Proper Storage Space -
Ensure proper disposal of biohazardous waste according to national laws/regulations. If these are not present, stick to the procedures defined in the biosafety manual developed in phase 1. The template biosafety manual chapter “Waste Segregation and Disposal” (already provided in phase 1) contains a waste segregation chart which can serve as an example. The chapter itself also contains more information on standardizing proper disposal of biohazardous waste. If autoclaves are present, you can adapt the Biological and Medical Waste Decision Tree developed by the University of Winsconsin to your situation.
Ensure that all staff members are adhering to the procedures regarding disposal of biohazardous waste in the biosafety manual by regular verification (check if potentially infectious waste is discarded in the container that will be autoclaved and/or burned). Check if there is no potentially infectious material within reach of public or animals (e.g. unburned litter around burning pits/incinerators).
Biosafety Manual Chapter “Waste Segregation and Disposal” -
Start monitoring the parameters that critically influence quality of examination results, such as:
- Temperature of incubators
- Temperature of refrigerators and freezers
- Environmental pressure differential between the laboratory and the external environment (in case a negative pressure system is present)
- Environmental temperature
- Other parameters if applicable and necessary (i.e. when deviation from standard norms negatively influences test results).
An example of a temperature log (for one month) is provided. The TB CAP laboratory toolbox template SOPs also provide some examples of temperature log sheets (for one trimester) in:
- Use and Maintenance of Freezers (in annex 1)
- Use and Maintenance of Refrigerators (in annex 1)
- Use and Maintenance of an Incubator (in annex 1)
Besides that the SLMTA training provides also an example of an environmental parameter monitoring chart in which multiple parameters can be monitored in one chart.
As you can see in the provided templates, critical intervals are included in the logsheets. Establish critical intervals for each parameter that is recorded in your laboratory and include these in the logsheets for recording that parameter. This way the person recording the parameter can directly see if the value falls outside the critical interval and subsequently act upon this. When this is the case the underlying problem must be identified and appropriate corrective actions must follow.
This activity is necessary to control all critical parameters that may influence the quality of the results negatively (by which the quality of results is thus indirectly controlled). Therefore, critical values need to be introduced for each parameter that is recorded so that, when the parameter exceeds the critical value, a corrective action procedure is initiated to correct the problem and prevent this from happening again in the future.
Template/Example Temperature Log Use and Maintenance of Freezers (in annex 1) Use and Maintenance of Refrigerators (in annex 1) Use and Maintenance of an Incubator (in annex 1)
