Program Development and Baseline Review
Whether your institute is in the design/construction phase, or planning on conducting work with infectious material or biological toxins, a biosafety and biosecurity program must be developed and implemented before work begins. Under the best conditions, these programs inform design and are developed from the start of the design process. More often than not the facility or lab already exists and we must develop a program and procedures that accounts for existing capabilities and planed renovations.
Below are some of basic areas of support we provide in program development:
- Technical advice on strategic planning and processes
- Risk assessment and biorisk management tools and capability
- Development of manuals, plans, SOPs and forms
- Documented training and trainee competency
- Day-to-day problem solving
Institutes that have been in operation for a few years, have expanded or changed missions, or have simply grown in size all benefit from a third party program review. A baseline review identifies the strengths and areas for improvement by benchmarking the program against successful programs supporting similar missions and evaluating the program in relation to best practices, within nationally accepted guidelines to include CDC/NIH BMBL 5th Edition and NIH RAC guidelines. Conducting a systematic, independent, and documented program and laboratory audit is one of the tools we use in the process.
Sample elements in baselining a program include review of:
- Operational aspects
- Practices and procedures (normal, irregular, emergency)
- Facilities, laboratories, equipment (maintenance, documented safety inspections, etc)
- Interviews with individualsManagement aspects
- Policies and procedures
- Records (training, accident, etc)