Successfully scaling a next-generation sequencing (NGS) lab takes careful preparation. Myriad complexities are involved, any of which could cause delays and extra expense. For some labs, scaling up means hiring more staff and ordering more consumables, or even acquiring additional physical space to house lab equipment and supplies. If this extra space isn’t available onsite, labs might need to rent in another location, even if this means having to courier samples across town.
Whether your lab has been intending to scale up for some time or you’re responding to a high-pressure situation, like a pandemic, you need to have a plan in place. To help you get started, we’ve put together a list of things to consider.
1. Infrastructure readiness
Do you have the physical space to scale up? Growing the business might mean you need more staff and somewhere for them to perform the work. It will also likely involve more equipment and more consumables. A few things you will want to consider are where these will be located so that they’re easily accessible, and the complex processes of inventory management and logistics.
You’ll also want to ensure your IT infrastructure can accommodate increased volumes and technology updates. Start by assessing your data storage, servers, and management systems to ensure they can handle larger datasets securely and efficiently.
In terms of software, your laboratory information management system (LIMS) or laboratory information system (LIS) needs to be scalable to meet increasing throughput without compromising data integrity. You might have to add customizations to your existing system for further efficiency or to support inventory management, or you could consider using a cloud solution like Labbit for more agility and flexibility.
2. Skilled workforce
Scaling up will mean reassessing your workforce, too. Do you have enough people with the right skills to manage expanded operations and perform the work? If not, you might choose to reskill some of your existing staff or hire new talent. An alternative option is to bring in consultants to augment your team — this can help you ramp up more quickly and add vital expertise at an important juncture.
Remember that new staff must have unique login IDs for your lab software, and permissions and security set to appropriate levels based on the access they require. Potentially, they’ll also need training on your systems and any customizations you’ve implemented.
3. Robust workflows and quality control measures
If you’re looking to increase throughput, you should review and optimize your lab workflows to handle the higher load efficiently. When you do this exercise, be sure you represent workflows accurately so that you don’t skip a step or add unnecessary complexity.
At the same time, you’ll want to ensure you are maintaining quality and accuracy by implementing stringent quality control protocols. You might choose to:
- Migrate from spreadsheets to a LIMS to reduce manual processing
- Set up the software environment for maximum productivity
- Implement barcode scanning to increase efficiency and reduce errors
- Add automation to boost speed and efficiency
- Build integrations to improve performance
- Move beyond the happy path in your LIMS implementation to address potential errors and exceptions for smoother operations
When you make adjustments to your workflows, be sure to update your standard operating procedures (SOPs) so that they remain in sync.
4. Compliance and regulations
Regulatory compliance is important for labs of all sizes. But it’s even more critical for larger-scale operations. Before you scale your lab, ensure you understand the regulations pertinent to your business, geographic location, and market. For example, the FDA recently proposed a new rule for laboratory developed tests (LDTs). The consultants you work with should be familiar with working in a heavily regulated sector and be able to help you implement your lab software so that you can navigate regulatory compliance.
5. Risk mitigation strategies
Challenges are bound to arise during the scaling process. We highly recommend labs develop contingency plans to manage the unexpected. Beyond that, it’s also important to maintain data backups — full and incremental — so that data can be restored quickly if necessary.
A full disaster recovery plan is another component to consider and is especially important as your business grows. The higher your throughput, the bigger the impact if a server fails or you are subject to a breach or attack. Safeguarding your valuable data is critical. We also recommend regularly assessing processes, technology, and outcomes to identify areas for improvement and optimization.
6. Budget and funding
The scaling-up process will itself require a budget for equipment, consumables, staffing, and software upgrades — and increased shipping fees if you find yourself with an additional location offsite. However, labs often forget that software requires maintenance to support their evolving business. You should also plan for increased costs associated with ongoing operations and maintenance.
7. Timeline, milestones, and change management
As with any large transformation, a clear timeline with achievable milestones to track progress is a must. Furthermore, you’ll need effective change management. Communication around changes should be transparent and reassuring, describing why the changes are occurring and the benefits to staff and the business. We also recommend using formal change control processes.
Scaling up your lab is a complex undertaking, but a partner can help you streamline the process. At Semaphore, we’ve assisted labs of all sizes — from small labs that still use spreadsheets for tracking samples to large labs with extensive nationwide operations. If your lab wants to scale, get in touch with us today.