Introduction tuberculosis laboratory biosafety manual. Biosafety guidance for tb lab procedures technical consultation in sept. The third edition of the who laboratory biosafety manual is a helpful reference and guide to nations that accept the challenge to develop and establish national codes of practice for securing microbiological assets, yet ensuring their availability for clinical, research and epidemiological purposes. All individuals working in bscs should be observed to ensure they follow correct working practices before they routinely perform testing in the bsc. Good microbiological technique and appropriate use of biosafety equipment by well trained staff remain the fundamental elements of laboratory biosafety. Ucimc school of medicine clinical locations are not covered by this manual. Stop tb partnership global laboratory initiative gli. National tb lab services report biosafety background aphl and cdc completed the national tb laboratory services survey in 2011. For this new edition, the manual has been extensively revised and expanded. The challenge for managers of tb programmes and staff at laboratories, particularly in resourcelimited. Pdf tuberculosis laboratory biosafety manual lasinrang. The maximum containment laboratory biosafety level 4 6. Provided by the centers for disease control and prevention cdc.
Basic, containment and maximum containment bsl yet to be defined technology. Laboratory biosafety guidance for xdr mycobacterium tb strains, including. Biosafety in the mycobacteriology laboratory dr christopher gilpin tb laboratory strengthening and diagnostics unit who geneva. Laboratory biosafety guidance for xdr mycobacterium tb strains, including occupational infections. It will also be of interest to public health professionals in the field of global tb control. Tb for tb specific floor design see the appendix 12 of priorities for tb bacteriologiy services in lowresource countries and the section 2. The purpose of the survey was to assess the overall ability of commercial, clinical and public health laboratories. I expect my employer to define all biosafety risks related to my job and to take responsibility for preventing lab acquired. The fourtier classification system of biosafety levels 14 described in whos laboratory biosafety manual2 provides broad guidance on basic concepts of biosafety for the development of national and international codes of practice. 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.
Equipment should also be tested regularly to ensure that it continues to perform safely. The laboratory biosafety manual describes a fourtier classification system of biosafety. Standard precautions are based on the principle that all blood, body fluids, secretions, nonintact skin, mucous membranes, and excretions except sweat may contain transmissible infectious agents. 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. The laboratory manual references best practices from the clinical and laboratory standards. Who laboratory biosafety manual lbm lbm has served the global biosafety community for more than 30 years with practical guidance on biosafety who manual 1st edition, 1983 risk group. 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. The gli secretariat is hosted by the world health organization who global tb programme. A questionnaire was developed to obtain information from researchers across nigeria from july 2014 to july 2015. Biosafety and risk assessment biosafety is the application of a combination of admin.
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. Tuberculosis laboratory biosafety manual ncbi bookshelf. Laboratory biosafety guidance related to the novel coronavirus 2019ncov. Appropriate biosafety conditions for performing routine tb culture and antimicrobial susceptibility testing have been lacking. Tb a chapter on biosafety specific to tb laboratories sampled from the gli microbiology manual is provided. World health organization, communivable diseases cluster. Laboratory guidelines research institute for tropical medicine. Association of public health laboratories 1 issues in brief. Tuberculosis laboratory biosafety manual languages. Bmbl is by its nature a continuously revised manual, and each revision refines and extends the contributions to previous editions. 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. Highquality laboratory diagnosis of tb is the basis. This training module will discuss safe work practices for performing laboratory tests for the isolation and identification of mycobacterium tuberculosis.
Tuberculosis laboratory biosafety manual vii abbreviations ach air. Create an office area separate from laboratory rooms with adequate office furniture. It all starts in the acceptance of correct, adequate and quality specimens brought to the laboratory. The recommendations are based on assessments of the risks associated with different technical procedures performed in different types of tb laboratories. Gli stepwise approach towards tb laboratory accreditation. 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 indiv. Tb microscopy network accreditation an assessment tool. National tb lab services reportbiosafety background aphl and cdc completed the national tb laboratory services survey in 2011. Tuberculosis laboratory biosafety manual world health organization.
Spill clean up procedures minimal aerosols produced. Laboratory safety the handbook global edition stop tb. Handbook on tuberculosis laboratory diagnostic methods in. 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. Welcome to the website of the global laboratory initiative gli the global laboratory initiative gli is a network of international partners dedicated to accelerating and expanding access to quality assured laboratory services in response to the diagnostic challenges of tb, notably hivassociated and drugresistant tb.
This series of free, interactive modules, developed by aphl in collaboration with the centers for disease control and prevention, promotes competency, quality and safety in common mycobacteriology testing practices. Safety equipment tuberculosis laboratory biosafety. Who guidance on regulations for the transport of infectious substances, 20 2014 whohsegcr 2012. As described in the 5th edition of biosafety in microbiological and biomedical laboratories bmbl, m. The third edition of the who laboratory biosafety manual is a helpful reference and guide to nations that accept the challenge to develop and establish national codes of practice for securing microbiological assets, yet ensuring their availability for clinical. All tb laboratories, regardless of the procedures being undertaken, should enact a set of essential biosafety measures to minimize risks. Manual on collection, storage, and transport of specimens for tb testing producing reliable test results does not rely solely on the right performance of the stepbystep procedures of the test itself. Essential biosafety measures for tb laboratories 3. In the 2012 version of the who manual on biosafety in tb laboratories 8 more emphasis was. Status of laboratory biosafety and biosecurity in veterinary. The premise was that an approach to biosafety was needed that emphasized risk assessments of individual procedures and processes.
For any other combination of pathogen and procedures, a process similar to the one used here could be used to defi ne biosafety precautions. 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 union efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrugresistant tuberculosis. Chinese, english, french, portuguese, russian, spanish. Controlled access, anterooms, sealed windows, directional airflow, preventing recirculation of laboratory exhaust air, filtration of exhaust air before discharge to the outside, and thimble exhaust. Handbook on tb laboratory diagnostic methods in the. Exposure response plan for the laboratory handling of. Biosafety level 4 bsl4 is the highest level of biosafety precautions, and is appropriate for work with agents that could easily be aerosoltransmitted within the laboratory and cause severe to fatal disease in humans for which there are no available vaccines or treatments. This laboratory is now managed by malian laboratory staff and is processing samples at the national level. The who tuberculosis laboratory biosafety manual 2012 incorporated a risk assessment approach that considered the procedures being performed. Compliance with the criteria for laboratory practices, safety equipment. Laboratory biosafety is the process of applying a combination of administrative controls, containment principles. Infection with drug resistant tb poses an even greater risk of permanent disability or death.
Laboratory biosafety is the process of applying a combination of administrative controls. Handbook on tb laboratory diagnostic methods for the eu technical document 2 intended use and users the report, which provides both basic and referencelevel methods for the diagnosis of tb, is intended for use by laboratory experts. Tuberculosis laboratory biosafety manual chinese who. It will be expected to be functional at the end of 20. A risk assessmentbased approach to defining minimum. Laboratories need leaders who can effectively utilize the laboratories resources, maximize the laboratoriescapacity to detect disease, and advocate for laboratories in. Such equipment offers no assurance of protection unless the operator is competent and uses proper techniques. Written protocols, as well as a biosafety manual, should be issued to laboratory staff and they should sign a form to confirm that they have read and understood the required protocols. The fourtier classification system of biosafety levels 14 described in whos laboratory biosafety manual 2 provides broad guidance on basic concepts of biosafety for the development of national and international codes of practice. Tb is a serious illness, but most immunocompetent people 9095% control the infection and do not develop the disease. Accommodation and environmental conditions the bsl 3 laboratory has now been built, but awaits full installment of all equipment. Safety equipment may be used to eliminate or reduce certain risks in tb laboratories table 4. This manual was developed from the expert group meeting. Though the 4th edition is in draft form the time to.
World health organization 2012 tuberculosis laboratory biosafety manual. Wcln resources wisconsin state laboratory of hygiene. Installing biosafety level 3 containment laboratories in. The purpose of the institutional biosafety manual is to assist both personnel and. 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. Guide for providing technical support to tb laboratories in low and middleincome countries 1 preface the global laboratory initiative gli, established in 2007, is a working group of the stop tb partnership. The biosafety officer should develop an action plan so that the laboratory comes into compliance with these requirements. Infectious aerosol a particulate suspension of infectious agents that has the potential to be inhaled and cause infection. Bio safety precautions in tuberculosis laboratory article pdf available in the indian journal of tuberculosis 603. After attending this session, participants will be able to differentiate the 3rd and 4th edition of the who laboratory biosafety manual.
Historically, the information in this publication has been advisory is nature even though legislation and regulation, in some circumstances, have overtaken it and made compliance with the guidance. Performing a risk assessment laboratory biosafety manual, 3rd edition, 2004 link to world health organization website guidelines for safe work practices in human and animal medical diagnostic laboratories link to cdc website. Technical document handbook on tb laboratory diagnostic methods for the eu 1 background and introduction francis drobniewski tuberculosis tb is a major cause of morbidity and mortality in europe. Despite the availability of this contained laboratory, safety of staff is. Review instances of hiv, hbv, hcv or other bloodborne pathogens and tb and other serious infectious diseases in students, researchers, and health care workers, to. Risk assessment and the classification of tb laboratories. 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. Per january 20 all planned internal and external quality controls have taken place according to plan and results are discussed. Guide for providing technical support to tb laboratories. Installing biosafety level 3 containment laboratories in low.
Skip directly to site content skip directly to page options skip directly to az link. Tuberculosis laboratory biosafety manual corporate authors. In 2015, a biosafety level 3 bsl3 laboratory set up in a shipping container was donated to the malian ministry of health and public hygiene to provide capacity for tb testing. Pdf online tuberculosis laboratory biosafety manual. Guidelines for laboratory facility commissioning 8.
Who laboratory biosafety manual lbm revision update. Cdcaphl laboratory biosafety competencies for the bsl2, bsl3, and bsl4 laboratories. A second strategy, aimed at putting into place the basic safety measures applicable to all types of laboratories, is. The challenge for managers of tb programmes and staff at laboratories, particularly in resourcelimited settings. There is too much work to be done to think about risk categories and biosafety risk assessments unless its spelled out in our sops. The uci biosafety manual applies to all uci faculty, staff, hosted visitors, students, participating guests and volunteers, contract laborers, supplemental personnel and employees of firms working at locations where uci has management control of specific biohazards. It is intended to inform rather than replace countrylevel requirements and standards for biosafety. Tuberculosis laboratory biosafety manual world health organization on. Information regarding demographics, knowledge of laboratory biosafety, availability and proper use of personal protective equipment ppe, any priority pathogens researched, attitude on and use of standard laboratory practices, and biosafety awareness was obtained using a. The tb lab biosafety plan should contain all of the components seen here on this slide. Chinese, english, french, portuguese, russian, spanish recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. 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 tb laboratory diagnostic methods in the european. Biosafety directive for mycobacterium tuberculosis complex mtbc. Biosafety recommendations for the contained use of. Guidelines for laboratory facility certification part ii. Interim laboratory biosafety guidance for xdr mycobacterium. Biosafety levels are based on the composite of the design features, construction, containment facilities, equipment, practices, and operational procedures required for working with agents from various risk groups. World health organization genevea, switzerland, 2012. Recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincome countries. Risk assessment and the classification of tb laboratories 2. Pdf biosafety precautions in tuberculosis laboratory. Tb lab biosafety manual eng world health organization. The who laboratory biosafety manual 4th edition youtube. Recommendations for investigating contacts of persons with infectious tuberculosis in low and middleincom. In us microbiology labs today, the practice of treating tb specimens with special precautions is well established.
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