Safety equipment may be used to eliminate or reduce certain risks in tb laboratories table 4. Tuberculosis laboratory biosafety manual ncbi bookshelf. Is there a projectspecific biosafety manual or exposure control plan. Every laboratory should have a written biosafety program that serves to train staff and is used for reference whenever there are questions.
The manual now covers risk assessment and safe use of recombinant dna technology. 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. This manual on biosafety for tb laboratories is adapted from the who s laboratory biosafety manual, 3rd edition. In the 2012 version of the who manual on biosafety in tb laboratories 8 more emphasis was. 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. Previous molecular epidemiology studies have shown that. Tuberculosis tb is a chronic infectious respiratory disease caused by mycobacterium tuberculosis mtb, which seriously endangers human health. 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.
World health organization 2012 tuberculosis laboratory biosafety manual. Recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. Pdf biosafety precautions in tuberculosis laboratory. 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.
Science safety security finding the balance together. Manual, the us biosafety in microbiological and biomedical laboratories, and the international consensus document cen workshop agreement cwa 15793. Pdf tuberculosis laboratory biosafety manual lasinrang. It will be expected to be functional at the end of 20.
Ventilated workstation manual for afb smear microscopy. Does the pi or laboratory supervisor have a procedure for having staff demonstrate proficiency before working at bsl2. 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. Failure to perform biosafety risk assessments and use appropriate mitigations failure of equipment, e. Chinese, english, french, portuguese, russian, spanish. Pdf feasibility of establishing a biosafety level 3. Gli biosafety projects biosafety guidance for tb lab procedures technical consultation in sept. The recommendations in this manual are based on assessments of the risks. Bio safety precautions in tuberculosis laboratory article pdf available in the indian journal of tuberculosis 603.
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. Guidance documents manuals ebsa european biosafety. Chinese, english, french, portuguese, russian, spanish recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. For this new edition, the manual has been extensively revised and expanded. Risk assessment and the classification of tb laboratories 2. Department of agriculture usda and centers for disease control and prevention cdc tuberculosis laboratory guidelines centers for disease control and prevention. Risk groups are classifications that describe the relative hazard posed by infectious agents or toxins in the laboratory. In this booklet you will find all the information that was already present in the earlier editions. This manual on biosafety for tb laboratories is adapted from the whos laboratory biosafety manual, 3rd edition. Guidelines for laboratory facility commissioning 8.
There is little information on how mycobacterium tuberculosis survives transfer between hosts via the ambient air, and for how long m. Laboratory safety nanomaterials, schools, hazard analysis. Introduction tuberculosis laboratory biosafety manual. Stop tb partnership global laboratory initiative gli. The tb lab biosafety plan should contain all of the components seen here on this slide. Risk assessment and the classification of tb laboratories. 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. Biohazard levels and biosafety protection for mycobacterium. Many species within the genus mycobacterium are prominent pathogens, above all members of the m. This chapter describes clinical, taxonomic, genetic. Awareness and training session for laboratory workers at ojha campus. 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. Laboratory safety the handbook global edition stop tb. Biosafety directive for mycobacterium tuberculosis complex mtbc.
Tuberculosis laboratory biosafety manual world health organization. The manual now covers risk assessment and safe use of recombinant dna technology, and provides guidelines for the comissioning and. Compliance with the criteria for laboratory practices. World organization for animal health oie guidelines for responsible conduct in veterinary research identifying, assessing, and managing dual use ivbw veterinary biosafety handbook.
Routine practices and additional precautions for preventing the transmission of infection in healthcare settings. 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. Mycobacteriology laboratory manual stop tb partnership. Guidelines for laboratoryfacility certification part ii. This manual was developed from the expert group meeting. It all starts in the acceptance of correct, adequate and quality specimens brought to the laboratory.
Despite the availability of this contained laboratory, safety of staff is a legitimate. Tuberculosis laboratory biosafety manual national prevention. Reasons why unexpected laboratory associated infections lais occur. Bio safety precautions in tuberculosis laboratory tuberculosis. Tuberculosis laboratory biosafety manual languages. 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. 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. Laboratory biosafety is the process of applying a combination of administrative controls. The who tuberculosis laboratory biosafety manual 2012 incorporated a risk assessment approach that considered the procedures being performed.
Guidelines for laboratory facility certification part ii. Canadian biosafety handbook, second edition canada. It is intended to inform rather than replace countrylevel requirements and standards for biosafety. World health organization genevea, switzerland, 2012. A risk assessmentbased approach to defining minimum. Only a few alterations have been made, especially in the text concerning decontamination and inactivation. Tuberculosis laboratory biosafety manual vii abbreviations ach air. 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. Served as initial standardized global biosafety guidance. Biosafety directive for mycobacterium tuberculosis complex.
The recommendations are based on assessments of the risks associated with different technical procedures performed in different types of tb laboratories. A service of the national library of medicine, national institutes of health. National plan for reliable tuberculosis laboratory services using a systems approach. 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. Laboratory guidelines research institute for tropical. Who guidance on regulations for the transport of infectious substances, 20 2014 whohsegcr 2012. Be familiar with the performance characteristics of. As described in the 5th edition of biosafety in microbiological and biomedical laboratories bmbl, m.
Comparison of ambient air survival of mycobacterium. The maximum containment laboratory biosafety level 4 6. Biosafety recommendations for the contained use of. Such equipment offers no assurance of protection unless the operator is competent and uses proper techniques. Tb is transmitted through the respiratory tract and poses great biosafety risks to laboratory technicians and staff, through direct or indirect contact with mtb. 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. Although very few data are available concerning the incidence of laboratory associated tuberculosis. 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.
Mycobacterium tuberculosis infectious dose 110 organisms no safe level of exposure airborne droplet nuclei can be spread through normal air currents for long. Per january 20 all planned internal and external quality controls have taken place according to plan and results are discussed. Safety equipment tuberculosis laboratory biosafety. Essential biosafety measures for tb laboratories 3. Interim laboratory biosafety guidance for xdr mycobacterium. Report of an expert consultation on the uses of nucleic acid amplification tests for the diagnosis of tuberculosis. Best practices in mycobacterial research laboratories. Laboratory guidelines research institute for tropical medicine. 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. Inaugurated in 2009, the cilm develop diagnostic tools for infectious diseases. 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. This is the third, revised edition of the booklet biosafety in the laboratory.
University of california, irvine environmental health and safety. Mycobacteriology laboratory manual v list of abbreviations and acronyms afb acid fast bacilli ast antimycobacterial susceptibility testing. Equipment should also be tested regularly to ensure that it continues to perform safely. 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. Updated guidelines for the use of nucleic acid amplification tests in the diagnosis of tuberculosis. 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. Laboratory biosafety and biosecurity risk assessment. Tuberculosis, hepatitis b and c to physicians, health care providers, and epidemiologists for the benefit of the patient and population of lao pdr. 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. In china, the regulations on the biosafety management of pathogenic microorganism laboratories have been issued, classifying the pathogenic microorganisms. 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. Although very few data are available concerning the incidence of laboratoryassociated tuberculosis. 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. 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.
Provided guidance on several facets of lab safety addressed several safety programs. Since 2012, the laboratory has adopted a quality management system for. Accommodation and environmental conditions the bsl 3 laboratory has now been built, but awaits full installment of all equipment. A plan or manual specific to the project shall be developed as part of the bua registration process for each ibcregistered project.