Laboratory biosafety and biosecurity risk assessment. There is little information on how mycobacterium tuberculosis survives transfer between hosts via the ambient air, and for how long m. Previous molecular epidemiology studies have shown that. Failure to perform biosafety risk assessments and use appropriate mitigations failure of equipment, e. Routine practices and additional precautions for preventing the transmission of infection in healthcare settings. The fourtier classification system of biosafety levels 14 described in whos laboratory biosafety manual2provides broad guidance on basic concepts of biosafety for the development of national and international codes of practice. Per january 20 all planned internal and external quality controls have taken place according to plan and results are discussed. In developing minimum biosafety precautions for laboratories that conduct diagnostic testing for tuberculosis tb, a risk assessmentbased approach was used to define minimum precautions for individual procedures and processes. For this new edition, the manual has been extensively revised and expanded. Every laboratory should have a written biosafety program that serves to train staff and is used for reference whenever there are questions. Tuberculosis laboratory biosafety manual languages.
Awareness and training session for laboratory workers at ojha campus. Hence, the national tuberculosis reference laboratory ntrl has developed this manual to provide a guide on the proper collection, storage and transport of both pulmonary and extrapulmonary specimens for tuberculosis tb testing. Biosafety directive for mycobacterium tuberculosis complex mtbc. The laboratory biosafety manual published by the who describes in detail a fourlevel biosafety classification system levels 14 and provides guidance for the development of relevant national and international operating guidelines. Since 2012, the laboratory has adopted a quality management system for. Pdf biosafety precautions in tuberculosis laboratory. Over the past years, a broad spectrum of pathogenic agents, such as bacteria, fungi, viruses, parasites, or genetically modified organisms, have been described and gained a substantial concern due to. Stop tb partnership global laboratory initiative gli. Be familiar with the performance characteristics of. A risk assessmentbased approach to defining minimum. A plan or manual specific to the project shall be developed as part of the bua registration process for each ibcregistered project.
Canadian biosafety handbook, second edition canada. Mycobacteriology laboratory manual stop tb partnership. Best practices in mycobacterial research laboratories. Who mycobacteriology biosafety manual 2012 handbook on tb laboratory diagnostic methods for european union2018 efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrugresistant tuberculosis. This manual was developed from the expert group meeting. Compliance with the criteria for laboratory practices, safety equipment, and facility design and construction recommended by the cdc in bio safety in microbiological and biomedical laboratories for laboratories in which work is done with indigenous or exotic agents. Pdf tuberculosis laboratory biosafety manual lasinrang.
Tuberculosis laboratory biosafety manual vii abbreviations ach air. Gli biosafety projects biosafety guidance for tb lab procedures technical consultation in sept. Many species within the genus mycobacterium are prominent pathogens, above all members of the m. The manual now covers risk assessment and safe use of recombinant dna technology, and provides guidelines for the comissioning and. This manual describes the minimum biosafety measures that should be implemented at the different levels of tuberculosis tb testing laboratories to reduce the risk of a laboratory acquired infection. Bio safety precautions in tuberculosis laboratory tuberculosis. Is there a projectspecific biosafety manual or exposure control plan. It will be expected to be functional at the end of 20. Biosafety recommendations for the contained use of. The challenge for managers of tb programmes and staff at laboratories, particularly in resourcelimited settings, has been to interpret the generic riskgroup assignments and biosafety levels into specific precautions relevant to a countrys activities.
Tuberculosis laboratory biosafety manual national prevention. Compliance with the criteria for laboratory practices. In this booklet you will find all the information that was already present in the earlier editions. Laboratory safety nanomaterials, schools, hazard analysis. Laboratory guidelines research institute for tropical.
Laboratory safety the handbook global edition stop tb. Guidance documents manuals ebsa european biosafety. Who laboratory biosafety manual having served for global biosafety community hereinafter, who manual for more than 20 30 years, since it was first published in 1983, the laboratory biosafety manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. Department of agriculture usda and centers for disease control and prevention cdc tuberculosis laboratory guidelines centers for disease control and prevention. The tb lab biosafety plan should contain all of the components seen here on this slide. Risk groups are classifications that describe the relative hazard posed by infectious agents or toxins in the laboratory. Biohazard levels and biosafety protection for mycobacterium. World organization for animal health oie guidelines for responsible conduct in veterinary research identifying, assessing, and managing dual use ivbw veterinary biosafety handbook. Guidelines for laboratory facility commissioning 8.
It is intended to inform rather than replace countrylevel requirements and standards for biosafety. In the 2012 version of the who manual on biosafety in tb laboratories 8 more emphasis was. Equipment should also be tested regularly to ensure that it continues to perform safely. Manual, the us biosafety in microbiological and biomedical laboratories, and the international consensus document cen workshop agreement cwa 15793. Tb is transmitted through the respiratory tract and poses great biosafety risks to laboratory technicians and staff, through direct or indirect contact with mtb. For more than 20 years, since it was first published in 1983, the laboratory biosafety manual has provided practical guidance on biosafety techniques for use in laboratories at all levels. Risk assessment and the classification of tb laboratories 2. Pdf feasibility of establishing a biosafety level 3. The laboratory safety group within the environmental health and safety office ehs has developed the biological safety manual to provide guidance on the safe handling of biological materials, safety practices to minimize the risk of exposure to potentially infectious materials, and procedures for. Tuberculosis laboratory biosafety manual v executive summary following a technical consultation held between the world health organization who and the united states centers for disease control and prevention cdc in atlanta, ga, in september 2008 on strategies, approaches and partnerships that could be implemented to improve laboratory biosafety. Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. Essential biosafety measures for tb laboratories 3. Does the pi or laboratory supervisor have a procedure for having staff demonstrate proficiency before working at bsl2. A manual of written standard operating procedures sops for the laboratory, in combination with this manual and the cdcnih publications biosafety in microbiological and biomedical laboratories, 5th edition and guidelines for research involving recombinant or synthetic nucleic acid molecules, provide general requirements for working with biological agents.
Cdcaphl laboratory biosafety competencies for the bsl2, bsl3, and bsl4 laboratories. Such equipment offers no assurance of protection unless the operator is competent and uses proper techniques. Safety equipment tuberculosis laboratory biosafety. Tuberculosis laboratory biosafety manual ncbi bookshelf. Chinese, english, french, portuguese, russian, spanish.
Recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. Risk assessment and the classification of tb laboratories. Although very few data are available concerning the incidence of laboratory associated tuberculosis. World health organization, following a technical consultation held between the world health organization who and the united states centers for disease control and prevention cdc in atlanta, ga, in september 2008 on. In addition, there are, at present, more than 150 species of environmental mycobacteria nontuberculous mycobacteria ntm which exert various degrees of pathogenicity and virulence in humans. The canadian biosafety handbook cbh, 2 nd edition, 2016 is intended as a companion document to the canadian biosafety standard cbs, 2 nd edition, 2015. World health organization 2012 tuberculosis laboratory biosafety manual. The manual now covers risk assessment and safe use of recombinant dna technology. Reasons why unexpected laboratory associated infections lais occur. The risk group to which an infectious agent or toxin is assigned is the primary, but not only, consideration used in a biological risk assessment to determine the appropriate biosafety level in which a worker can handle the infectious agent or toxin. Interim laboratory biosafety guidance for xdr mycobacterium. World health organization genevea, switzerland, 2012. Introduction tuberculosis laboratory biosafety manual.
This manual on biosafety for tb laboratories is adapted from the who s laboratory biosafety manual, 3rd edition. Safety equipment may be used to eliminate or reduce certain risks in tb laboratories table 4. A service of the national library of medicine, national institutes of health. As described in the 5th edition of biosafety in microbiological and biomedical laboratories bmbl, m. Served as initial standardized global biosafety guidance. Despite the availability of this contained laboratory, safety of staff is a legitimate. Tuberculosis laboratory biosafety manual world health organization.
As part of the continuing effort to assess and monitor the quality and effectiveness of laboratory testing systems that support public health objectives of tuberculosis tb treatment programs, the cdc model performance evaluation program mpep was established to analyze the performance and practices of all known clinical and public health laboratories in the united states that. Science safety security finding the balance together. The maximum containment laboratory biosafety level 4 6. Laboratory biosafety is the process of applying a combination of administrative controls. Accommodation and environmental conditions the bsl 3 laboratory has now been built, but awaits full installment of all equipment. Report of an expert consultation on the uses of nucleic acid amplification tests for the diagnosis of tuberculosis. Laboratory biosafety is the process of applying a combination of administrative controls, containment principles, practices and procedures, safety equipment, emergency preparedness, and facilities to enable laboratory staff to work safely with potentially infectious microorganisms. Biosafety recommendations for manipulations of mycobacterial cultures all procedures for tuberculosis tb culture propagation and subsequent manipulation of the cultures are performed in bsl3 facilities the use of containment equipment e. Tuberculosis tb is a chronic infectious respiratory disease caused by mycobacterium tuberculosis mtb, which seriously endangers human health. The who tuberculosis laboratory biosafety manual 2012 incorporated a risk assessment approach that considered the procedures being performed. Handbook on tuberculosis laboratory diagnostic methods in the. The recommendations in this manual are based on assessments of the risks.
Ventilated workstation manual for afb smear microscopy. Guidelines for laboratory facility certification part ii. Guidelines for laboratoryfacility certification part ii. Footnote 5 it is a guidance document for canadian facilities where human and terrestrial animal pathogens are handled, that updates the guidelines originally published as part ii of the. Mycobacteriology laboratory manual v list of abbreviations and acronyms afb acid fast bacilli ast antimycobacterial susceptibility testing. This is the third, revised edition of the booklet biosafety in the laboratory. Tuberculosis, hepatitis b and c to physicians, health care providers, and epidemiologists for the benefit of the patient and population of lao pdr.
Only a few alterations have been made, especially in the text concerning decontamination and inactivation. Laboratory guidelines research institute for tropical medicine. Chinese, english, french, portuguese, russian, spanish recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. The recommendations are based on assessments of the risks associated with different technical procedures performed in different types of tb laboratories. Bio safety precautions in tuberculosis laboratory article pdf available in the indian journal of tuberculosis 603. Provided guidance on several facets of lab safety addressed several safety programs. Although very few data are available concerning the incidence of laboratoryassociated tuberculosis. University of california, irvine environmental health and safety. Who guidance on regulations for the transport of infectious substances, 20 2014 whohsegcr 2012.
Comparison of ambient air survival of mycobacterium. Laboratory biosafety manual third edition, 2004 pdf, 1. National plan for reliable tuberculosis laboratory services using a systems approach. Mycobacterium tuberculosis infectious dose 110 organisms no safe level of exposure airborne droplet nuclei can be spread through normal air currents for long. This manual describes the minimum biosafety measures that should be implemented at the different levels of tuberculosis tb testing laboratories to reduce the risk of a laboratoryacquired infection. Biosafety directive for mycobacterium tuberculosis complex. This chapter describes clinical, taxonomic, genetic. This manual on biosafety for tb laboratories is adapted from the whos laboratory biosafety manual, 3rd edition. It all starts in the acceptance of correct, adequate and quality specimens brought to the laboratory. Inaugurated in 2009, the cilm develop diagnostic tools for infectious diseases. In china, the regulations on the biosafety management of pathogenic microorganism laboratories have been issued, classifying the pathogenic microorganisms.
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