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Does Your Biosafety Program Stack Up? 10 Questions to Test Your Compliance Status
by Brenda E. Barry, Ph.D.

Work with tissues, cells, microorganisms, and animals are routine activities in many biomedical research and biotechnology laboratories.  Yet, exposures to potentially infectious materials during many of these activities can present underestimated health hazards for laboratory staff.  The most serious concerns arise when staff members contract infections from the materials that they handle.  Biotechnology companies understand the importance of complying with the Center for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) Biosafety in Microbiological and Biomedical Laboratories (BMBL) biosafety guidelines, and the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard to minimize the likelihood of such infections.  The biosafety guidelines summarized in the BMBL can be simply defined as a group of practices and procedures designed to provide safe environments for laboratory staff who work with potentially hazardous biological agents. Yet, remaining in compliance can be demanding as research and development activities expand into new areas.  As a proactive approach, biotechnology companies recognize the value of investing in a laboratory review to ensure compliance with existing guidelines and standards. 


One method to assure compliance with BMBL guidelines is to conduct a laboratory review.  This can be done either with the help of a biosafety consultant or by developing a compliance checklist that is customized to the specific activities taking place in your laboratory or company.


A fundamental element of the laboratory review process is recognition that working safely in laboratories requires integration between the implementation of safe practices by laboratory staff and the operation of the laboratory facility.  This combination of approaches, termed “containment” in the BMBL, includes primary containment provided by the use of good microbiological techniques and safety equipment, as well as secondary containment provided by the design and operational procedures of the laboratory facility. 


Answering the following series of questions prior to the laboratory review can be very helpful in identifying the level of detail required as part of the evaluation. The variety of elements to be addressed include the following:

  1. Who conducts the training for new and current employees? Does the principal investigator make sure that laboratory staff is properly trained for managing new agents and conducting new procedures?


  1. If you handle human materials, are you in compliance with the requirements of the OSHA Bloodborne Pathogens Standard?


  1. How do you manage and maintain training records for your employees? Do your training and personnel records meet the requirements of the OSHA Bloodborne Pathogens Standard?


  1. Do you have a biosafety manual and when was it last updated?


  1. Have you established an Institutional Biosafety Committee as required by NIH guidelines?


  1. Is personal protective equipment available, and are employees properly trained in its use?


  1. Are biosafety cabinets used properly and inspected annually?


  1. Do you have proper biosafety signage on doors and laboratory equipment?


  1. Do you conduct annual biosafety laboratory inspections?


  1. Are your employees trained on the current shipping and receiving regulations for biological materials?


The laboratory review provides an excellent gauge for a company to use in evaluating its biosafety compliance status. It also addresses the company’s ethical responsibilities to its employees to provide first-rate laboratory conditions, as well as reducing potential liability and possible health concerns regarding exposures to infectious agents. Conducting a laboratory review can support companies in meeting the CDC-NIH goal of providing safe environments for both laboratory personnel and the surrounding community.


Brenda E. Barry, Ph.D.
Brenda E. Barry, Ph.D.

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