Feasibility of establishing a BSL3 tuberculosis culture lab in a resource-limited setting

Background: Despite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility.
Methods: Between September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode.
Results: The laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012.
Conclusions: From our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.
Ssengooba, W., et al. Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda. Health Research Policy and Systems 2015, 13:4

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License to Serve - U.S. Trainees and the #Ebola Epidemic

Before medical school, Sara L., now a fourth-year resident, worked for 6 years as a microbiologist at the Centers for Disease Control and Prevention. While there, she focused on hemorrhagic fevers, and she went to West Africa several times to assist in outbreaks. Indeed, until recently, Sara was one of only a few hundred people in the United States who was trained to work in a biosafety level 4 “spacesuit” laboratory, which requires the same personal protective equipment (PPE) needed for working with Ebola. As the current Ebola epidemic exploded, and after careful deliberation, Sara sought and secured a position with an international aid organization, got approval from her residency program's leadership, found coverage for her time away, and 6 weeks later, was set to deploy. Then she got a call from her institution's risk-management department with disappointing news: the institution would not support her deployment.

Rosenbaum L. License to Serve — U.S. Trainees and the Ebola Epidemic. N Engl J Med. 2014 Dec 17. 
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The hidden face of academic researches on classified highly pathogenic microorganisms

Highly pathogenic microorganisms and toxins are manipulated in academic laboratories for fundamental research purposes, diagnostics, drugs and vaccines development. Obviously, these infectious pathogens represent a potential risk for human and/or animal health and their accidental or intentional release (biosafety and biosecurity, respectively) is a major concern of governments. In the past decade, several incidents have occurred in laboratories and reported by media causing fear and raising a sense of suspicion against biologists. Some scientists have been ordered by US government to leave their laboratory for long periods of time following the occurrence of an incident involving infectious pathogens; in other cases laboratories have been shut down and universities have been forced to pay fines and incur a long-term ban on funding after gross negligence of biosafety/biosecurity procedures. Measures of criminal sanctions have also been taken to minimize the risk that such incidents can reoccur.
Devaux CA. The hidden face of academic researches on classified highly pathogenic microorganisms. Infect Genet Evol. 2015 Jan;29:26-34. doi: 10.1016/j.meegid.2014.10.028. Epub 2014 Nov 7.
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Preventing Worker Fatigue Among #Ebola Healthcare Workers #CDC

The National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA) recognize that healthcare workers and responders involved with cases related to Ebola in the United States may be required to work longer or unusual shifts. This can involve extended shifts (more than 8 hours long), rotating or irregular shifts, or consecutive shifts resulting in more than the typical 40-hour work week. Long work hours may increase the risk of injuries and accidents and can contribute to poor health and worker fatigue.
Additionally, the personal protective equipment (PPE) required for working with Ebola patients can increase workers’ core body temperature, contributing significantly to fatigue. Although these guidelines are geared toward workers responding in the United States, the same concepts apply to those working in other countries.

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A los patrocinadores de #AMexBio

Las personas interesadas en promover sus productos en el próximo VII Simposio de Bioseguridad y Biocustodia de la Asociación Mexicana de Bioseguridad A.C. Existen amplias oportunidades para posicionar sus marcas ante este público especializado.​
Mayor información con:

Cristina Wilhelm 

Guillermo Wilhelm Ferriz
Nextel Id: 52*167789*3
Tel Fijo: (473) 732-4681
Tel Celular: (55) 4410-6383
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