Survey of Biorisk Management in Clinical Laboratories in Karachi, Pakistan

This study was designed to survey the existing Biosafety and Biosecurity levels of the clinical laboratories in order to assess the controls in place to keep the laboratory workers, and the surrounding community, safe from an outbreak of infectious diseases in Karachi, Pakistan. The survey also helped to evaluate the present level of Biorisk management practiced in these clinical laboratories. Karachi was selected as the site of this survey because it is the hub of commercial activities in the region and has a population of about 25 million. Place and Duration: This study encompassed a period of 8 months (January 2011 to August 2011) and covered laboratories in the 18 towns of Karachi, Pakistan. To begin the study, a survey questionnaire was developed with the help of Sandia National Laboratory (Albuquerque, New Mexico, USA). Results of the survey were disseminated to the relevant target audience and increased the level of information on these topics as well as ways to implement Biorisk management in accordance with CWA 15793-2008 (European Committee for Standardization, 2008). The results were also conveyed to the stakeholders (top management, laboratory management, laboratory managers, laboratory technologists, laboratory technicians, etc.). This study reflects the current level of Biosafety practices in clinical laboratories in Karachi, Pakistan, where major gaps were identified in all the critical areas of Biosafety and Biosecurity, including risk assessment, standard microbiological practices, primary barriers/personal protective equipment, and laboratory design/secondary barriers, and select agent protocols. The gaps included the following: • Biosecurity is not at all defined or understood. • There is no protocol/guidance for reporting laboratory acquired infections (LAIs). • There is no framework for registering these laboratories before commissioning. • Limited or no training for Biosafety/Biosecurity is available on a continual basis. • No regulatory body oversees Biorisk/Biosecurity activities or lab registration. This study revealed that the degree of negligence regarding these requirements for clinical laboratories is very serious and work on an emergency basis is required to introduce, implement, and furnish Biosafety and Biosecurity guidelines. Training and literature in both English and the local Urdu language need to be developed and distributed. However, other extraordinary measures are also required because the majority of laboratories working at BSL-2 have no biosafety cabinets (BSCs), resulting in microbiological work being done on the open bench. The main purposes of this study were (1) to develop a culture in which Biosafety and Biosecurity practices become routine in these laboratories; and (2) to commission a National Regulatory Body to define/dictate these guidelines and to ensure that new laboratories are registered before they are commissioned. In addition, this regulatory body will address the immediate registration of those laboratories already working.