When you use or implement any software system you hope it’s going to improve how you do things and impact the quality and integrity of your data. When adopting new software, many companies underestimate the business changes that it will introduce. This is especially true for systems that underpin your critical lab and sample management processes. Even if you already have systems in place, keeping them relevant as your needs change is essential. If you are prepared for change then these systems can deliver real business benefits and impact. This is especially true with Biobanking software that, amongst its proven benefits, can help promote “best-practice” in your lab and Biobank.
What’s meant by “best-practice” when it comes to Biobanking?
As a Biobank you will no doubt have to comply with the appropriate legislation. Compliance is not only a legal requirement but also instils best-practice. Many compliance requirements are there to make sure that what you are doing is of a high-quality and standard. Compliance gives labs and Biobanks that quality seal of approval. However, when implemented correctly compliance can also give you additional benefits including saving time and costs. So, don’t think of compliance as something to ‘get through’ but something that can help instil best-practice.
Your mandatory compliances may include prescribed processes that you should be following already. Your mandatory compliances may include the Human Tissue Act (HTA) or the Medicines & Healthcare product Regulatory Agency (MHRA). There are tangible benefits to following these in addition to simple compliance. These include helping improve the quality and viability of your samples and, ultimately, research.
In addition to compliance, there are also several standards out there that focus on best-practice. These include ISO standards such as ISO 17025, ISO 15189 and ISO 20387. Plus, industry best-practice guidelines, such as ISBER. They all aim to help you to operate efficient, logical and audited processes to record and evidence your professionalism. By following these you can gain operational efficiencies and improve quality, both of which have a positive impact on your reputation.
There are also seven Caldicott principles that clearly lay out best-practice for the management and protection of patient data.
So, there’s a lot of guidance out there on what is “best-practice”. In order to adopt these, you may have to change your standard operating procedures (SOPs). But the right software can also make a difference.
Here are 6 ways in which your Biobanking software or Laboratory Information Management System (LIMS) can help instil best-practice.
1. Traceability – knowing what tissue samples you have in your inventory
As a Biobank you rely on the tissue samples you have in your inventory. And you need to be able to find them quickly. You probably have samples coming and going all the time. At any one time you need to know exactly what tissue samples you have in store and where they are exactly. In addition, you also need to know where your samples have been – and what’s happened to them along the way. Biobanking software can show you this and every time you move your samples automatically create an audit record. All of this can be done without any extra effort by you.
But it’s not just your tissue samples you need to manage. You also work with and, therefore, need to manage reagents, equipment, staff and other resources. A LIMS or Biobank system can help you do this using features such as an equipment booking system, reagent stock management, staff training and re-qualification, and diary management.
2. Instilling quality with data validation and checks
Best practice isn’t just about knowing where everything is and what needs to be done next. It’s also about recording easily and accurately what you have already done. A good Biobank Information Management system (BIMS), such as Achiever Medical, will include many features to make sure that you can only enter valid data. In addition, they also make sure that the process of adding and managing your data is simple and avoids human error.
Biobanking software can make sure you enter valid data by allowing you to set up allowed ranges, mandatory fields, picklists, default values and intelligent warnings. Plus, you can also add field hints to inform your users what data they need to enter.
Some Biobanking systems also allow you to define rules between fields. This means that when you enter a value into one field, this controls what you can enter in the related field.
Importantly, in Biobanking systems you can tag fields as mandatory. This is for critical data that you absolutely must record. As a result of making fields mandatory, you ensure that data records are as complete as possible. Plus, if you can control the mandatory property using business rules then you are making sure that you are capturing the right data at the right step in the process.
Finally, your Biobanking software can also help with rules that dictate when records must be entered. And if not, then the system can highlight that a record is missing to the user or escalate it to a line manager.
All these features can work tirelessly to maintain your data quality. Good data promotes good processes – all of which leads to improving your quality.
3. Streamlining processes with pre-built workflows
In addition to validating data entered by users, your Biobanking software may have pre-built workflows covering your critical and regular processes. This means you can ‘hit the ground running’ with your system quickly. These processes are designed to hand-hold your users through complex processes. Plus, they automate some of your repetitive process. All this helps reduce human error as well as improve efficiency and consistency.
In addition, you can validate each step of the process before the next step is presented to the user. This will help ensure that your users complete the process fully without forgetting any steps. If a process is “a doddle” to follow, then you won’t get it wrong!
Good Biobank software or LIMS will also allow you to set up templates to automate common tasks. And you can update these are your requirements change. Did your best practice just get better? Then modify your template to match it without needing to get IT or your supplier involved. You are in the driving seat.
4. Getting approval and carrying out those extra checks
You will need to review and approve some of your critical processes. Biobanking software can support your review process by sending automatic emails to the approver. These can include a link you can click to go straight to the record they need to review and approve. The approval is automatically logged. In addition, the system sends an automatic notification once you have granted approval (or refused) so that your users can carry out the next steps. You shouldn’t have to remember everything yourself!
5. Checking your progress using oversight dashboards
Once our Biobank system is fully supporting your processes and they are ticking over nicely, you’ll need a way to view your whole operation. You want to be able to monitor processes, analyse costs and track performance. You want these broken down by staff, process type, lab and equipment. The information must be presented in an easy to understand format, that you can export. And you want to see bang-up-to-date data. This is where dashboards and reports come in.
Advanced Biobank software, like Achiever Medical, gives you dynamic, real-time dashboards. And it even comes with some ‘out-of-the-box’ to get you started. You can configure the dashboards to meet your requirements. Plus, as they are fully integrated, you control who can see them. They also honour any data filters and encryption rules.
6. Carrying out your own internal lab audits and quality checks
As well as your dashboards that allow effective oversight by management, Biobank systems give you evidence that your processes are as good as you say they are. You can give this information to external auditors.
Advanced Biobanking systems, like Achiever Medical, also have a built-in proactive auditing module. This module allows you to schedule and carry out your own internal audits to build evidence and to highlight non-compliances. It provides a feedback loop that drives your process improvement. In additional, it allows your staff to be well practiced in auditing as quality becomes part of your everyday and reduces some of the fear of external audits.
Remember – you’re already following best-practice and being fully supported by your Biobanking software – so the audits help you to show off that success to the wider world.
A final thought about how modern Biobanking software promotes best-practice
When defining best-practice for Biobanks there are a number of readily-available guidelines, industry-standards and compliances that can help you. But make sure you choose the ones that are relevant to how you work and define quality.
Modern Biobanking software or LIMS can help improve quality and efficiencies in your lab and across your Biobank. Some advanced systems already have many of the workflows, security, compliance, auditing and analysis functionality you need built-in. Many of these have been designed in conjunction with researchers and Biobanks – and are already tried and tested. All of this means you get a helping hand towards implementing best-practice. And you can configure the ones that are missing or not quite how you want them.
- The seven Caldicott Principles: https://www.igt.hscic.gov.uk/Caldicott2Principles.aspx
- ISBER Best Practices: https://www.isber.org/page/BPR
- ISO – https://www.iso.org/certification.html
- How Achiever Medical helps you meet the Caldicott Principles – https://www.interactivesoftware.co.uk/2019/06/12/how-achiever-medical-helps-you-meet-the-caldicott-principles/