The recommendations in this manual are based on assessments of the risks associated with different technical procedures performed in different types of tb laboratories. Handbook on tuberculosis laboratory diagnostic methods in. We wish to emphasize that the sixth edition of bmbl remains an advisory document recommending best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective. Handbook on tuberculosis laboratory diagnostic methods in the. The choice of clothing and equipment depends on the nature of the work. The hazards presented by radiation are of physical rather than biological origin and thus are not covered in the biosafety manual. Biohazard levels and biosafety protection for mycobacterium. Videos on the who youtube channel promote laboratory quality. Interim laboratory biosafety guidance for xdr mycobacterium. It is intended to inform rather than replace countrylevel requirements and standards for biosafety. Chinese, english, french, portuguese, russian, spanish recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries.
Medical laboratory science program biosafetysafety manual. The text has served as a functional biosafety manual for the university. This manual was developed from the expert group meeting. For this new edition, the manual has been extensively revised and expanded. This fourth edition of the manual builds on the risk assessment framework introduced in the third edition.
Mycobacteriology laboratory manual find tb resources tb. Department of health and human services, cdc, 2011 xdr tb is defined as mdr tb that is also resistant to one of three other tuberculocidal drugs. Biosafety level 1 bsl1 is the basic level of protection and is appropriate for agents that are not known to cause disease in normal, healthy humans. Personal protective equipment and clothing may act as barriers to minimize the risk of exposure to aerosols, splashes and accidental inoculation. Laboratory diagnostics and discrimination of subspecies and strains 27 6. 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. Feasibility of establishing a biosafety level 3 tuberculosis. Usda security policies and procedures for laboratories and. A thorough, evidencebased and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with. The manual now covers risk assessment and safe use of recombinant dna technology, and provides guidelines for the comissioning and.
Medical laboratory science program biosafetysafety. This biosafety manual has been developed by the environmental health and safety ehs department at michigan state university. These guidelines for biosafety laboratory competency outline the essential skills, knowledge, and abilities required for working with biologic agents at the three highest biosafety levels bsls levels 2, 3, and 4. Tb poses immense biosafety risk to laboratory workers. As described in the 5th edition of biosafety in microbiological and biomedical laboratories bmbl, m. Biosafety directive for mycobacterium tuberculosis complex. Is there a projectspecific biosafety manual or exposure control plan. It is available in english, french, russian and spanish. Jan 15, 2015 background despite the recent innovations in tuberculosis tb and multidrug resistant tb mdr tb diagnosis, culture remains vital for difficulttodiagnose patients, baseline and endpoint determination for novel vaccines and drug trials. A plan or manual specific to the project shall be developed as part of the bua registration process for each ibcregistered project. Biosafety in microbiological and biomedical laboratories bmbl has served as the cornerstone of biosafety practice in the united states since its initial release in 1984. References tuberculosis laboratory biosafety manual. Checklist for periodic evaluation of tb infection control.
Environmental health and safety office biological safety manual 04 2012 ix. The manual describes the basic requirements for facilities and practices, which can be. A comprehensive quality management system ensures that laboratories comply with recognized standards as well as biosafety and biosecurity regulations. Tuberculosis laboratory biosafety manual languages. World health organization, communivable diseases cluster.
The manual describes the basic requirements for facilities and practices, which can be adapted to follow local or national regulations. This report was revised and renamed handbook on tb laboratory diagnostic methods in the european union in 2016 and further revised and renamed handbook on tuberculosis laboratory diagnostic methods in the european union updated 2018 with changes to chapters 6. This document and other pertinent biosafety training information and training materials are now available on the office of environmental health and safety web site. Laboratory biosafety is the process of applying a combination of administrative controls. Tuberculosis laboratory biosafety manual national prevention. The degree of protection recommended is proportional to the risk associated with an agent. Tuberculosis laboratory biosafety manual world health organization. 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. Declarations of interest tuberculosis laboratory biosafety. Reliable and timely laboratory investigation results are fundamental to decisionmaking in almost all aspects of health services. Biosafety level 2 bsl2 is appropriate for handling moderaterisk agents that cause human disease of varying severity by ingestion or through percutaneous or mucous membrane exposure. Laboratory biosafety is the process of applying a combination of administrative controls, containment principles, practices and procedures, safety equipment.
Biosafety in microbiological and biomedical laboratories. Who has therefore also developed several tools and training courses in these areas, including. A combination of work practices and physical containment requirements designed to reduce the risk of laboratory infection when working with infectious material. Hbv, mycobacterium tuberculosis tb and may not kill all types of nonlipidcontaining viruses. Monitoring progress against global and national indicators on tb infection control included within the checklist are five key standards in red font for reporting against the two global and national tbhiv indicators for tbic as detailed in a guide to. Tuberculosis laboratory biosafety manual stylus publishing. Protect personnel from exposure to infectious agents prevent environmental contamination. Does the pi or laboratory supervisor have a procedure for having staff demonstrate proficiency before working at bsl2. Alcohols are volatile and flammable and must not be used near open flames. Personal protective equipment and clothing tuberculosis. Herein, we share our experience of establishing a bsl3 culture facility in uganda as well as 3years performance indicators and post tb vaccine trials.
The who tuberculosis laboratory biosafety manual 2012 incorporated a risk assessment approach that considered the procedures being performed. Recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. The manual is part of msus biosafety program, which was established to accomplish the following goals. The quality of laboratory services thus not only directly affects the quality of health care for individual patients it is also crucial to a nations. The laboratory quality manual template contains illustrative examples of the content of a quality manual and of standard operating procedures, and supports the lqms training toolkit and the lqsi tool. Mycobacteriology laboratory manual v list of abbreviations and acronyms afb acid fast bacilli ast antimycobacterial susceptibility testing. Mycobacteriology laboratory manual ii edita pimkina, infectious diseases and tuberculosis hospital af. Checklist for periodic evaluation of tb infection control in. Abstract this laboratory manual references best practices from the clinical and laboratory standards institute clsi, the foundation for innovative new diagnostics find mgit procedure manual, and laboratory procedures from the national institutes of health tb research unit, as well as biosafety recommendations from the world health organization who and the us centers for disease control.
Who global tuberculosis programme christopher gilpin, karin weyer who health systems and innovation ivana knezevic, tiequn zhou, hyena kang, francis gabriel moussy. Before leaving the laboratory, staff should remove their protective clothing, and wash their. Jul 09, 2012 the cdc has also released an interim laboratory biosafety guidance for extensively drugresistant xdr mycobacterium tuberculosis strains. Pdf tuberculosis laboratory biosafety manual lasinrang. Incidence of tuberculosis in laboratory workers working with m.
University of toledo biosafety and security manual page 2 conducting research at biosafety level bmbl, cdcnih guidelines. The members of this panel recom mended that biosafety guidelines be developed to address the unique operational needs of the diagnostic laboratory community and that they be science based and made available broadly. Biological safety manual 04 2012 ii table of contents. Tuberculosis laboratory biosafety manual ncbi bookshelf. More than 200 cases of laboratory acquired infections with m. In 2012, the chinese centers for disease control and prevention cdc reported that 10% of all the. The manual describes the basic requirements for facilities and practices, which can be adapted to follow local or national regulations or as the result of a risk assessment. Chinese, english, french, portuguese, russian, spanish. Do not use 70% ethanol to clean a class ii, type a recirculating biosafety cabinet. Protective clothing should be worn whenever staff work in the laboratory see box 6. Dec 19, 2017 the asu biosafety manual also requires that all laboratory animal facilities, operational practices, and quality of animal care meet applicable standards and regulations e. A service of the national library of medicine, national institutes of health.
The manual now covers risk assessment and safe use of recombinant dna technology, and provides guidelines for the comissioning and cetification of laboratories. Pdf laboratory biosafety manual fourth edition ahmed f. Laboratory specific biosafety manual checklist each laboratory is required to have a lab specific biosafety manual and cannot be borrowed or copied from another lab. Guidelines for safe work practices in human and animal. Mycobacteriology laboratory manual find tb resources. Following a technical consultation held between the world health organization who and the united states centers for disease control and prevention. Laboratory biosafety manual, fourth edition laboratory biosafety manual, fourth edition and associated monographs isbn 97892400111 electronic version.
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