Easing health and safety compliance in the lab

Health, safety, and security in laboratories are of growing concern to the public, government agencies, research institutions, and now also to scientists. Here is our guide to easing the compliance hassle for scientists Management of compliance with regulations and risk management requirements has become complicated and expensive – and it’s going to get worse. The key to building a sustainable compliance management program is first to acknowledge the realities of compliance management and then to focus on reducing the hassle to scientists.

It’s all too easy for things to awry in the scientific laboratory. In recent years, a US microbiology lab was linked to a nationwide salmonella outbreak, a University of Wisconsin employee was infected in a laboratory conducting unauthorised experiments with a controlled pathogen, a scientist died as a result of a fire in a University of California at Los Angeles (UCLA) research lab, and – most recently – a Yale University student died in a chemistry lab accident.

Government agencies have developed a myriad of rules and regulations about the use, documentation of approvals and activities, and disposal of chemicals, equipment, research animals, biological agents, x-ray and nuclear materials, and other high-risk and hazardous elements and activities. These regulations are not always enforced, which can lead to lax practices at many laboratories. However, in the US, regulatory agencies are starting to bear down on offenders: UCLA has been fined more than $123,000 within the past year, and the University of Texas was fined $1 million for lax safety practices.

Compliance information management is expensive and complicated: tracking, managing, and reporting on the compliance status of multiple scientists, students, affiliated workers, as well as each piece of equipment and hazard class is an arduous task. Today’s research institutions and companies typically manage this information via paper, pencil, filing cabinets, and spreadsheets. Those that also use databases are often no better off than those using manual methods alone because each area tracked requires its own database – one to track laboratory equipment certification, one for scientists who work with animals, one for those who work with x-ray or nuclear materials, another for chemicals, and so on. Even with additional support staff to manage the disparate systems it is virtually impossible to gain the insight needed across databases to assess compliance as a whole — which equipment has been certified and licensed, what equipment is due for testing/calibration and when, which people are certified on each piece of equipment, who needs training and when, etc. – and this example only takes into consideration compliance management for equipment. Each database takes people and time to gather the information by lab audits/visits and directly from the scientists, enter the data, update it, and periodically cross-check against other databases. Factor in the typical laboratory personnel turnover of 20% annually and the problem quickly goes from expensive and out-of-hand to expensive and out-of-compliance. This leaves institutions with a level of liability that they are unable to measure or mitigate, not to mention the high overhead costs.

Completing compliance tasks is confusing for scientists. Nearly all compliance management is dependent upon scientists completing tasks, including registration and licensing documents, training courses, inventories, and health screenings. A few tasks must be completed only once but most must be completed on a periodic or ongoing basis, each on a schedule dictated by regulatory agency and institutional risk management requirements. When combined with the various support staff requesting information and reminding them of a delinquent task, the result is a fragmented and confusing process for the scientists.

Few scientists are focused on improving health and safety compliance in the lab. Instead, they are focused on their experiments, obtaining and analysing results, and publishing. Compliance tasks are at best auxiliary to a scientist’s mission and therefore will never be top priority. Most scientists already have the mindset that lab safety and compliance is at least in part unnecessary.

Compliance requirements have increased, but management methods have not scaled well. Compliance and risk management requirements, as well as the focus on enforcing them, have increased substantially in the past decade. However, the organisational approach, methods, and tools provided to scientists by their institutions for understanding requirements, completing tasks, tracking, and viewing compliance information have for the most part not changed. Simply put, the approaches that worked when the requirements were fairly simple have not effectively scaled with the increase in complexity and volume of regulations. In result, it is difficult for scientists to figure out what is it they have to do. They are plagued by last minute “urgent” reminders, having to log into multiple databases with multiple usernames and passwords, completing multiple word processing documents, and so on. It is also important to remember that support staff spend a lot of time managing multiple databases, paper files, and desktop folders, manually cross checking this information, and staying on top of scientists for information.

Reducing the costs and hassle by reducing the requirements is no longer an option. Some institutions have responded by reducing the requirements down to highly truncated compliance tasks (e.g. oversimplified registration documents) and applying rubber-stamp approvals. Regulatory agencies are looking into more inventive ways to make institutions as well as scientists more accountable, including freezing grants for those who do not comply.

Shifting all the responsibility to compliance staff isn’t effective. As scientists are required to complete compliance tasks, institutions and companies cannot completely offload the responsibility onto additional support staff. Furthermore, proper lab safety and compliance requires people who know the regulations, are familiar with the scientific techniques and reagents, and understand risk management. Experienced compliance personnel are now expensive and it is quickly becoming cost prohibitive to support large compliance staff.

Saving money by leaving it to the scientists is too risky. Putting all or most of the responsibility onto the scientists has saved money for a number of institutions and companies. However, this is not an acceptable solution provided the current risks of negative publicity, fines, lawsuits, higher insurance, injury, and death.

If the goal is to operate productive and cost-effective labs, then the executives of institutions and companies, with the support of principals of the labs, must recognise that the costs and hassles of compliance are only getting more burdensome. They must be willing to devote resources toward solving the problem in a manner that is scientist-friendly and can be managed by a core team of experienced compliance staff members.

Putting in place more effective information technology is by itself not the sole solution to easing compliance management in labs; however, it is the key enabler through its ability to reduce the bother surrounding the completion of tasks and data management.

The following are guidelines for choosing the right IT solutions to manage compliance:

• Most importantly, look for an integrated system of applications that manage and provide reports for many aspects of laboratory safety and compliance to avoid data silos and to streamline oversight.
• Choose a modular system that enables the institution to make incremental investments based on both scope of work and priority of requirements.
• Resist the urge to customise existing features in a commercial system or to build a solution in-house – the costs are very high and few projects deliver the intended results.
• Choose a system that is easy to use and easy to access. Ideally, choose one that integrates with existing IT systems to eliminate the need for additional usernames and passwords.
• Look for a secure web-based system that enables scientists to complete tasks remotely (e.g. web-based forms, online training) and compliance staff to enter data while in the labs on laptops or tablets.
• Choose a system that enables the lab principals and scientists to view their requirements, records, and compliance status – this helps greatly with individual “ownership” and accountability.
• Find a solution that that provides automated alerts to the scientists and compliance staff about pending requirements and deadlines.

Adopting this approach will enable laboratories to become safer and to spend less time managing the processes surrounding compliance. Most importantly, it will enable the scientists and researchers within the laboratories to focus on their research and will keep costs predictable and risk at a manageable level.

Author: Nathan Watson is president of BioRAFT, a US-based provider of laboratory safety and compliance management solutions.

Contact: e: Nathan.Watson@BioRAFT.com.