There’s no shortage of red tape associated with establishing or renovating a recombinant DNA lab, and the paperwork and exercises associated with obtaining an rDNA Permit or other permissions can be daunting to complete. One of the most important steps in this involved process is the inevitable OBA (Office of Biotechnology Activities) visit, which often entails a very detailed vetting of your lab, with strict criteria for compliance. In order to make sure your lab not only passes this important test, but excels in it, here are four ways to prepare for this visit in order to get off on the right foot with the OBA.
IBC Paperwork
With great power comes great responsibility, and with great responsibility comes great paperwork. The IBC is expected to have an extensive list of forms and papers specific to their committee ready in advance of the lab’s OBA visit including:
- A roster containing names, contact information, and biographical sketches of all members of the IBC, the BSO, and the resident experts on human, plant, and animal gene transfer
- A copy of all IBC meeting minutes from the past two years
- Copies of paperwork associated with the initial registration of the lab with the NIH
- IBC lab inspection reports and checklists
- IBC standard operating procedures, charter, etc.
Labeling and Cleanliness
One piece of paperwork that carries an exceptional amount of weight in this process is the Institutional Biosafety Committee’s (IBC) lab inspection report and checklist. As part of their visit, the OBA will examine not only the record of how often the lab was inspected and the result, but also how thoroughly the IBC examined the lab space. If this assessment is deemed inadequate, the OBA may need to conduct a separate inspection, which is likely to be very rigorous. This walk-through will also examine labeling in the lab, especially signage related to the Biosafety Level (BSL) of each lab space as well as proper demarcation of lab hazards like radioactive materials or sharps.
Ensuring Working Equipment
In advance of the NIH OBA visiting your lab, it should be double checked by the IBC that all equipment, especially equipment related to sanitation, is in full working order. This is particularly important in BSL-2 and BSL-3 labs, which require the use of an autoclave in disinfecting equipment. Perhaps the most important pieces of equipment to check for labs rated BSL-2 or higher are the biosafety cabinets, especially those that require external ventilation.
The NIH OBA doesn’t just check equipment designed for research though, as sinks and eyewash stations should also be present on the IBC’s lab inspection report, and are expected to be fully operational. OBA members will also have an eye on the report for presence of access restrictions for BSL-2 and higher labs.
Ensuring Workers’ Well-being
The main goal of all of the above criteria is to ensure the safety of not only the environment, but also that of your workers. It is for this reason that the OBA will stringently and painstakingly assess the measures taken to ensure worker safety in your lab, as well as appropriate worker training materials. It is therefore the responsibility of the lab, particularly the PI (Principle Investigator) to work in conjunction with the IBC and the OBA to ensure that there are injury and spill protocols in place in the event of a workplace incident, and biosafety levels for each lab space should be clearly demarcated.
Pro Tip: One of the most overlooked aspects of worker’s wellbeing is allergy treatment and prevention when dealing with lab animals. Use our upcoming webinar to make sure you’re up to speed in this category.
It should also be observed that all members of the lab team are using the proper level of personal protective equipment for the BSL of the lab in which they are working. Finally, in terms of paperwork, there should be a clear and concise employee medical surveillance program determined by the IBC in place that is well known by the lab staff.
For more information on topics like this, contact us for a free biosafety assessment.
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