The following is a compilation of responses to a survey that asked individuals responsible for planning, design, operations, and maintenance of high-containment facilities to rank their priorities for 2014 and make open-ended comments regarding those priorities. The issues identified in this survey will be the focus of Tradeline’s upcoming conference—The 2014 International Conference on Biocontainment Facilities—on April 10‐11 in Scottsdale, Arizona.
The respondents ranked their overall priorities as follows:
- Operations and maintenance processes and cost reduction
- Commissioning, recommissioning, or validation
- Accreditation, certification, and regulatory requirements
- Renovation or new construction
Below is a summary of their comments:
Operations and maintenance processes and cost reduction
Maintenance/operations requirements and processes together constitute by far the most pressing priority for biocontainment facility programs. Budget constraints are putting severe pressure on biocontainment facility managers to do more with less, and this is having a detrimental effect on ongoing operations. Understaffing and lack of preventative maintenance are adding risks to the operational safety of biocontainment facilities. New MEP solutions that are easy to repair and maintain, ensure the safety of maintenance and research teams, and reduce operating costs are in high demand. Service access to mechanical equipment to minimize disruption of operations is highly sought, not only for new facility designs, but also for upgrades and expansions. Mechanical equipment is aging, and facilities are in desperate need of upgrades. Staffing issues relating to recruiting, training, and retaining operating and maintenance personnel continue to be a challenge when the increasing operations and maintenance skills needed to match the complexity of new facilities and controls are not always available.
Representative statements regarding operations and maintenance processes and cost reduction:
- Budget constraints—It would be good to have some current benchmarks and operational cost data for BSL‐2, BSL‐2+, and BSL‐3, and biomanufacturing facilities (pilot/large scale).
- Our challenge is shutdowns for maintenance of facilities when BSL facilities are operated by one department, and research in the facility is controlled by multiple faculty research groups.
- We need new designs that allow maintenance to be carried out without impacting operations.
- Designing facilities that operate efficiently and save energy, and designing systems that need minimal maintenance and are easily maintained are our priorities.
- Hiring staff that has the necessary expertise. Very difficult to find.
- We need to improve our preventative maintenance program.
- Reliability of equipment for continuous operation is our challenge.
- Keeping it all working as equipment ages, and maintenance staff changes.
- Maintain facility with reduced staff and reduced budget.
- Operating an old facility that needs upgrades.
- Personnel training for O&M is our greatest challenge.
- Reducing operations and maintenance costs.
- The continual challenge of doing more with less.
- There is increasing focus on achieving efficient O&M on the part of universities without interference with operations of the lab.
- Training and knowledge of system integration along with operation.
- Training and staffing—increasing O&M operations skills to match complexity of new facilities and controls.
- Training staff on O&M.
Commissioning, recommissioning, or validation
Commissioning, recommissioning, and validation are increasingly becoming a top focus for operations and maintenance planners as more BSL facilities and related equipment become outdated and need upgrades. Best practices and procedures for shutdowns and restarts top the list of needs. New equipment and systems for operational process, maintenance, and energy efficiency can be installed during shutdowns, so best‐in‐class solutions, equipment upgrades, and designs are needed. There is a shortage of commissioning agents who have knowledge of Individually Ventilated Cage (IVC) operations for ABSL‐3 facilities and possess a deeper understanding of other non‐traditional lab equipment; these qualities are critical to the startup of new and renovated facilities. Keeping up with regulation and policy changes is daunting. There continues to be a significant need for clarification of regulatory requirements and processes associated with commissioning, recommissioning, and validation, and the industry would benefit from process standardization on frequency and requirements of recommissioning and validation.
Representative statements regarding commissioning, recommissioning, and revalidation:
- We are designing and implementing a continuous validation process for BSL‐3 labs. Hopefully, the CDC and USDA will approve.
- Our challenge is ensuring the project is ready for commissioning.
- Can’t find commissioners who understand IVC rack operation.
- Keeping up with regulations, rules, policy changes is very difficult.
- Meeting operational standards with an aging facility.
- Not all commissioning agents are created equal. We need a listing of those who can assist with annual BSL validation.
- The cost associated with maintaining these activities remains challenging.
- This is always a challenge. We plan and then plan again to make sure we don’t have any problems.
- This is always a challenging issue to address, which requires a well‐managed process.
- We’re preparing to have newly renovated space commissioned. I am sure we will have lessons learned.
- What constitutes the need for recommissioning?
- How frequently are other facilities going through complete recommissioning?
Accreditation, certification, and regulatory requirements
Almost all biocontainment facilities are understaffed and facing severe budget constraints, and the stream of routine inspections by APHIS, CDC, USDA, and FDA is getting more difficult and costly to manage. AAALAC certification is increasing in prevalence, as it is required by most grant funding authorities, which adds cost and time. There is high demand for software, processes, and systems that harmonize multiple regulatory and certification requirements and track data and reports. Changes to regulations, such as new tier‐one agents and the BMBL 5th Edition’s “no reversal of airflow” issue, are presenting new challenges to facility managers, as facility modifications and upgrades are required in order to remain compliant. Looming on the horizon is the ANSI Z9.14 standard for testing and performance verification of ventilation systems for BSL‐3 and ABSL‐3 facilities, which will likely be included in some federal and regional regulations once it is fully implemented. In addition, ABSA’s High Containment Laboratory Accreditation Program is now being initiated.
Representative statements regarding accreditation, certification, and regulatory requirements:
- AAALAC accreditation is a given for our program. Its costs need to be built into our budgets.
- All the paperwork and documentation are time consuming.
- Changes in regulations and keeping up are very difficult.
- Close to impossible to meet EHS/IBC demands!
- Getting approvals through the federal agencies is proving to be a challenge.
- Is it best to (have a manager of regulatory and certification programs) in‐house or third‐party?
- Keeping up with regulations, rules, policy changes is a high priority and difficult.
- Matching the correct regulatory compliance with the project objectives has been a challenge. The Guide and BMBL are great tools, but when do NIH regulations need to be implemented?
- Monitoring new governmental regulations.
- Regulations and certification are the most important aspect of the operation of the BSL lab.
- Must recertify to APHIS select agent program; new tier‐one agents.
- We are inspected by APHIS, CDC, USDA, and FDA. All of these events take significant time and money in the form of man-hours, the expenses for which we are unable to adequately recover.
- Quite complicated, as so many regulatory issues have to be met. We are doing international research.
Renovation or new construction
Renovations, upgrades, and new construction with the goal of updating facilities to be compliant with new regulatory and certification requirements, and making operational improvements, continue to top program agendas. Program managers are looking for construction best practices, metrics, and benchmarking—especially new technologies and systems to reduce energy, operations, and maintenance costs. They also are seeking new surface materials and enhancements for decontamination and waste treatment. New methods and strategies to consolidate and centralize facilities to reduce redundant systems, operators, and maintenance staff are in high demand.
Representative statements regarding renovation or new construction:
- Additional space and funding are needed to accommodate needs for expansion.
- Beginning construction of a new decontamination facility, approximately 40,000‐50,000 gallons per day.
- We want to create more centralized facilities resulting in more efficient ongoing operations.
- Development of a business case for a new facility is our biggest challenge.
- Economical isolation from other building utilities; space‐efficient equipment and systems.
- Expansion of current space. Fuller utilization of existing space. These are our challenges.
- Getting two new facilities up and running and managing occupancy relocations is our priority.
- New construction—we need to meet regulatory requirements and make spaces flexible for unknowns in the future of biocontainment.
- We are renovating a 1980 BSL‐3 lab into a “modern” BSL‐3 lab for efficiency and to comply with regulatory requirements.
- Our priority is the renovation of older ABSL‐3 suites to meet newer requirements by NIH and CDC.
- Schedules driving the project rather than the quality. Big issue in BSL‐3.
- We are trying to impress on the contractors the need for precision in the construction of a BSL‐3.
- We have minimized new construction with regards to high containment, and continue to struggle with getting customers… and developing a user base that will allow for sustainability.
- How do we plan for growth in uncertain times for research?