Biohazard levels, more commonly known as “biological safety levels” or “biosafety levels” are classifications of safety precautions necessary to be applied in the clinical microbiology laboratory depending on specific pathogens handled when performing laboratory procedures. Developed by the Centers for Disease Control and Prevention (CDC), this principle provides a way for medical laboratory scientists and other lab personnel to identify and limit any biological hazards and further reducing the risk in the laboratory. Biohazard levels, on the other hand, also support the principle of biosecurity, which is aimed at preventing the use of microorganisms as harmful biological agents.
Four classifications of biosafety levels (BSLs) exist. Each level contains specific recommendations for a clinical microbiology laboratory with a focus on laboratory practices, safety equipment, and facility construction. As each level progresses, additional biosafety considerations are included in the previous level. For example, BSL-2 has kept the components of BSL-1 with further requirements, and the same applies to BSL-3 (BSL-2 with additional requirements) and BSL-4 (BSL-3 with additional requirements). The complexity of each level is aligned with infectivity, disease severity, the microorganisms’ ability for transmission (including exposure routes), and the nature of the laboratory work to be performed.
Implementation of biosafety and biosecurity in the laboratory can initially present as an additional burden to laboratory staff and managers. However, the relevance of applying biosafety principles at the workplace should not be ignored.
Laboratory associated infections continue to become sources of diseases to the laboratory workforce. This is because of the failure in implementing fundamental control measures in the laboratory which stems from the most effective control which is elimination, followed by substitution, engineering controls, administrative, and personal protective equipment (e.g., respirator use) as the least effective.
Biosafety level 1 (BSL-1) controls microorganisms unusually known to cause disease with “minimal hazards” to the laboratory and the community. A recent study involves the selection of a BSL-1 bacteriophage surrogate to assess the efficacy of a chlorine-based surface disinfectant for Ebola outbreaks. This study recommends the collaboration of BSL-4 and non-BSL-4 facilities to assist in the selection and study of better surrogates which can be more effective in BSL-4 conditions.
Biosafety level 2 (BSL-2) controls microorganisms generating “moderate hazards” to the laboratory and the community. In other parts of the world, there are still no available guidelines for the validation and certification of biosafety laboratories. In 2017, issues regarding biosafety implementation in BSL-2 and BSL-3 were identified and analyzed. There is a need to make clear distinctions between certification and validation of clinical and microbiological laboratories. The need for its careful implementation must be first recognized.
Biosafety level 3 (BSL-3) includes the control of infectious agents which can cause both “serious hazards” and can cause a potentially lethal condition to laboratory and community via respiratory transmission of the organism. A typical example of an organism under this classification is the Mycobacterium tuberculosis, the bacterial agent responsible for tuberculosis. There has been a challenge for program and tuberculosis (TB) laboratory managers in implementing the specific considerations for this level particularly in resource-limited and TB, high-burden settings because there is insufficient biosafety expertise available to conduct individualized risk assessments for TB laboratories. The application of the biosafety level classification in BSL-3 requirements may not practically and adequately match the specific precautions relevant to the laboratories performing TB-related tests and procedures. To solve this problem, TB laboratories, instead of the BSL-3 which is a risk-group approach, adopted a risk-assessment approach. Any TB laboratory (a clinical, medical, or public health laboratory carrying our TB diagnostic tests) can be classified as low risk, moderate risk or a high TB risk based on the amount of aerosols generated during the conduct of a particular laboratory procedure. Countries, where TB is still a major public health concern, have already adopted these guidelines.
Biosafety level 4 (BSL-4) is the highest and “most complex” biohazard level, involving a relatively few clinical microbiology laboratories. There is a high transmission via aerosol making the pathogens more dangerous for laboratory workforce and the surrounding community. Marburg and Ebola viruses are included in this risk group. Stakeholders and international experts attended conferences in the past in Europe to revisit the issues emerged for BSL-4 implementation. They seek opportunities for the use of BSL-4 in public health, diagnostics and research in terms of its sustainability, improvement of existing training designs and curricula and strong collaboration to address biosafety and biosecurity. An integrated partnership of human, veterinary and military laboratories with BSL-4 facilities is necessary to unify its approach to the development of laboratory biosafety standards. The participation of BSL-4 in outbreaks can be substantial to attain a more effective outbreak management.
Risk-group classification of required biosafety precautions is ideally a logical approach to minimize laboratory-acquired infections. However, while each laboratory can easily identify and meet the special considerations required, the practicality to the actual day-to-day situation of the laboratory workflow is still more important. Strict adherence to these biohazard levels can be useful and beneficial for some facilities with capability to comply. In a similar case previously described for TB laboratories, a risk-based approach is more applicable so that safety precautions can "tailor-fit" to the activities of each clinical laboratory. Further studies are still essential to make this a reality at a global scale.
Biohazard Level and Significance
Knowledge on biohazard levels must not be limited to the laboratory professionals. All healthcare workers (clinicians, nurses, pharmacists, etc.) need to be aware of the categories of biohazard levels because they have the potential to impact every patient. For instance, signs and symbols should always be posted on medical and nursing floors when dealing with a high-level biohazard.
|||Coelho AC,García Díez J, Biological Risks and Laboratory-Acquired Infections: A Reality That Cannot be Ignored in Health Biotechnology. Frontiers in bioengineering and biotechnology. 2015 [PubMed PMID: 25973418]|
|||Mourya DT,Yadav PD,Majumdar TD,Chauhan DS,Katoch VM, Establishment of Biosafety Level-3 (BSL-3) laboratory: important criteria to consider while designing, constructing, commissioning [PubMed PMID: 25297350]|
|||Callaway E, Biosafety concerns for labs in the developing world. Nature. 2012 May 22 [PubMed PMID: 22622543]|
|||Gallandat K,Lantagne D, Selection of a Biosafety Level 1 (BSL-1) surrogate to evaluate surface disinfection efficacy in Ebola outbreaks: Comparison of four bacteriophages. PloS one. 2017 [PubMed PMID: 28531182]|
|||Mourya DT,Yadav PD,Khare A,Khan AH, Certification [PubMed PMID: 29434059]|
|||null. 2012 [PubMed PMID: 24404640]|
|||Parsons LM,Somoskövi A,Gutierrez C,Lee E,Paramasivan CN,Abimiku A,Spector S,Roscigno G,Nkengasong J, Laboratory diagnosis of tuberculosis in resource-poor countries: challenges and opportunities. Clinical microbiology reviews. 2011 Apr [PubMed PMID: 21482728]|
|||van Soolingen D,Wisselink HJ,Lumb R,Anthony R,van der Zanden A,Gilpin C, Practical biosafety in the tuberculosis laboratory: containment at the source is what truly counts. The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease. 2014 Aug [PubMed PMID: 25199000]|
|||Nisii C,Castilletti C,Raoul H,Hewson R,Brown D,Gopal R,Eickmann M,Gunther S,Mirazimi A,Koivula T,Feldmann H,Di Caro A,Capobianchi MR,Ippolito G, Biosafety Level-4 laboratories in Europe: opportunities for public health, diagnostics, and research. PLoS pathogens. 2013 Jan [PubMed PMID: 23349630]|
|||Kojima K,Booth CM,Summermatter K,Bennett A,Heisz M,Blacksell SD,McKinney M, Risk-based reboot for global lab biosafety. Science (New York, N.Y.). 2018 Apr 20 [PubMed PMID: 29674576]|