How to Build a Biosafety Program in Clinical Microbiology Labs

A strong biosafety program can improve and streamline overall safety in clinical microbiology labs

Building and maintaining a solid biosafety program in clinical microbiology labs takes planning and long-term dedication from all levels of lab staff. Protecting laboratory workers, the public, and the environment from potentially dangerous biological agents is crucial. While you may believe your lab follows all the current protocols and guidelines, reviewing the key elements of a biosafety program can help you identify and fill in any gaps to reduce or remove risks in your clinical lab.

1. Appoint a trained safety coordinator 

A survey of 5,000 US clinical labs that analyze or refer specimens that may contain microbial agents or toxins showed that only 18.6 percent of labs had at least one full-time staff member dedicated to biosafety. Only 15.9 percent of the respondents considered the person responsible for biosafety an "experienced biosafety professional." According to the survey, just over half of labs allocate biosafety responsibilities to multiple staff across all institutional laboratories. These results are concerning, considering the first step toward successful lab safety is to appoint a safety coordinator or biosafety officer. 

To fill this role in your lab, start by creating a description of the tasks and responsibilities of the safety coordinator or biosafety officer. The safety coordinator or biosafety officer is responsible for planning and managing the laboratory safety policy and must be well-versed in safe practices. After developing the job profile for the position, select an appropriately trained person to fill the role and inform your staff members of who they are and their role in the laboratory. To create a successful biosafety program, give the safety coordinator your full support so that staff members will cooperate with their safety plan.

2. Conduct a biosafety risk assessment 

Exposure to pathogens is a potential source of illness for employees and a threat to public health. The biosafety risk assessment involves gathering and evaluating all available information on potential sources of damage (also called hazards) to determine, manage, and reduce risks associated with exposure in the laboratory environment.

In a microbiology laboratory, the primary factors to consider in a risk assessment fall into two broad categories: agent hazards and laboratory procedure hazards.

To evaluate the agent hazards, laboratory biosafety professionals should first identify the infectious organisms likely to be encountered in the laboratory, the hazardous characteristics of the agent, and their risk in the absence of mitigating factors. Two aspects are particularly important to define agent hazards:

  1. how an organism can be transmitted in the laboratory, including its virulence, route of spread, and stability in the environment, and
  2. the potential consequences of infection, including the ability to produce disease in a susceptible host, severity of disease, and the availability of preventive measures (e.g., vaccines) and effective treatments.

The procedures used with the microorganisms (e.g., centrifugation, use of needles or other sharp materials, and vortexing) and the quantities handled will also affect the degree of hazard.

Importantly, performing a biosafety risk assessment before a specimen's arrival in the lab allows lab staff to prepare for specific situations, including the application of biosafety levels, facility safeguards for the corresponding level of risk, and the use of safety equipment that can help prevent laboratory-associated infections.

The sixth edition of Biosafety in Microbiological and Biomedical Laboratories—the overarching guidance document for biosafety practice in the US—is an excellent resource for information and guidance on conducting a risk assessment and implementing a risk mitigation program.

Another option is to hire an organization to do risk assessments for your lab. If you choose to outsource this service, evaluate the organization’s level of expertise and how familiar it is with the standards and regulations your lab must adhere to.

3. Establish competencies for safely working with biological materials

An essential component to a successful biosafety program involves establishing what behaviors and knowledge all lab staff need to safely work with biological materials. Competencies may include understanding the hazards in the lab and the risks associated with specific activities, knowledge of the procedures for using specific control measures (e.g., biological safety cabinets and personal protective equipment) and their limitations, and the ability to evaluate the effectiveness of those procedures and control measures.

Competencies should be observable and measurable. For example, an entry-level laboratorian must be able to explain storage and handling requirements for biological materials. A mid-level (experienced) laboratorian must be able to implement storage and handling requirements for these materials, and a senior-level (supervisor or manager) lab member must be able to formulate storage and handling requirements for biological materials. 

The safety coordinator can review the competencies annually and modify them based on changes and any issues identified in the lab.

Written or multiple-choice tests and direct observations can both be used to evaluate competencies.

The Guidelines for Biosafety Laboratory Competency is a good source to select applicable competencies for your microbiology lab. It outlines the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels (levels 2, 3, and 4) according to a worker's experience: entry-level, mid-level, and senior-level.

4. Provide safety orientations and continuing education for employees

Together, a lab’s biosafety risk assessment, mitigation plans, and established competencies for workers can inform a facility's education and training needs. Education and training, in turn, can be used to document competency.

Safety education and training should be conducted in research or clinical laboratories, including labs in academic, private, or government institutions. It should start when an employee is hired and continue for the duration of their employment. This training can include online or in-class sessions and hands-on workshops designed to provide theoretical and practical knowledge about safety measures when working with pathogenic biological agents and lab equipment. Emergency management training should also be carried out regularly in a laboratory setting because employees often get confused about emergency procedures and sometimes forget basic biosafety requirements.

Laboratories can develop and administer their biosafety training programs in-house or bring in a third-party organization to train their staff. The following table lists some topics appropriate for training sessions in biosafety:

Topics Appropriate for Training Sessions in Biosafety

1. Aseptic technique and procedures9. Biohazardous waste handling, packaging, and disposal
2. Personal hygiene10. Effective use of a biological safety cabinet
3. Primary containment barriers for appropriate biosafety levels11. Safe use of an autoclave
4. Personal protective equipment selection and use12. Safe use of a centrifuge
5. Decontamination, disinfection, and sterilization13. Safe use of sharp instruments
6. Biohazard signs14. Emergency and spills response procedures
7. Precautions for handling human blood and body fluids15. Monitoring and auditing
8. Packaging, transporting, and shipping biohazardous samples16. Reporting incidents and accidents

5. Design and schedule regular safety audits 

Monitoring the safety performance of a lab is a critical element of a solid safety program. As part of an audit, a safety committee consisting of trained staff and leadership observes individual safety practices, the operability of safety equipment, and compliance with safety rules. The number and frequency of internal audits may be dictated by an accrediting body or determined by the organization—this usually depends on the type of process being reviewed and its associated risks.

External audits by accrediting organizations are another valuable tool. They are usually performed at defined intervals, such as every two years or every third year for ISO standards. Laboratories can also link biosafety to their quality management program to permanently monitor the biosafety process—quality management audits then include safety audits. Importantly, regularly monitoring and documenting the performance of your staff and equipment allows you to provide staff with immediate training to correct any potential problems.

6. Establish an occupational health program to address safety incidents

As part of your robust biosafety plan, partner with an occupational health clinician for incidents and exposures, as well as selecting vaccines. In addition, create a well-described procedure for how exposed employees can access occupational health services to limit the consequences of an incident. The occupational health clinician can oversee and keep track of lab staff who have incurred an injury in the lab or who have been exposed to hazard agents or processes to help them recognize any signs and symptoms of illness. The occupational health clinician can also help the lab safety coordinator review the incident to avoid future occupational exposures.

Creating a culture of safety takes continual effort

Lab safety does not only depend on the materials and equipment in the lab. It also depends on the behavior and work habits of individual laboratorians and their sense of teamwork to protect themselves and their coworkers, as well as the environment.

Creating a culture of safety depends on strong leadership committed to supporting the activities of the safety committee and emphasizing safety as one of the lab’s top priorities. Leadership can strengthen a positive and proactive culture of safety by regularly discussing safety topics during staff meetings, reviewing the biosafety program annually, and including biosafety expectations in job descriptions, reviews of employee performance, and evaluations for career advancement.

A successful safety program requires a daily commitment from everyone in the lab. When lab leaders prioritize biosafety with a team genuinely committed to improving the safety of the workplace, microbiology labs can be highly secure environments.