Using a good laboratory information system (LIS) can go a long way toward making your lab more efficient. Not only does an LIS reduce potential errors that may be made throughout the chain of custody of a sample, it can also help employees better manage their time—so they’re not wasting it duplicating work or even waiting too long for the system to save information.
While these benefits certainly make a robust LIS worth the cost, there is another important advantage that simply cannot be ignored: the ability of an LIS to help a lab remain in compliance with numerous regulations, which have been consistently increasing in recent years. During the NSH Managing a Laboratory: Why Your LIS Matters webinar, Karen Dulaney, HT (ASCP), QIHC, MLT (AMT), Laboratory Manager at Arizona Digestive Health Laboratory, explains how your LIS can impact compliance.
“Your laboratory information system really should help you with your compliance for different regulatory bodies—including CLIA, CAP, and FDA. All of them have different regulations that your LIS should satisfy or meet, and a lot of them have to do with documenting who, what, where, when, and why kinds of questions,” said Dulaney. “If you’re going to do automation, or if you’re going to update your LIS, you really should have a system that keeps track of those things and gives you a report you can show to regulatory bodies.”
For example, with HIPAA regulations, there are numerous ways a strong LIS can help a lab meet its meaningful use stage requirements. For Stage 1, which pertains to data capture and sharing of information, your LIS should be able to keep patient data safe and secure by controlling access, auditing, integrity, and transmission of records. Dulaney suggests the following when considering these requirements.
Access controls
With access controls, you want to make sure that your LIS only allows certain users to access certain information, so different sensitive parts of patient records are only available to those who need them.
Audit controls
When someone in the lab inputs information into an LIS, you want a system that will give you specific details about what was done.
“I’ve used systems in the past where they’ve logged, but simply have a date. They’ll have a specimen with just a patient or an employee name, so I don’t really know exactly what that employee did. I just have a date and I know who did something, but I’m not getting the full information,” said Dulaney. “You really want to make sure that you get all of the information you need to satisfy these requirements.”
Integrity controls
To further ensure how well patient data is handled, an LIS should store information at every stage of a sample working through your lab. In addition to what employees add to a record, the system should also document what has been deleted from it, along with an explanation of who removed the information and why.
Transmission security
It’s important to remember that where information goes after you enter it into an LIS is just as important as the information itself.
“You should be able to see that your report went to the appropriate physician. If you’re sending a fax, you should be able to log where it was sent so you know the information is appropriate for that physician,” Dulaney said. “Or if I have an office looking for a report, I can go in and actually look to see if that report was received by a physician. We really should be tracking those things, and the information should be in your LIS to help you track it for regulatory bodies.”
While compliance issues like these may not necessarily be top of mind when you’re hard at work in the lab, they need to be considered because choosing the right LIS may mean the difference between remaining compliant and suffering serious consequences—including the lab losing its license.
A robust laboratory information system (LIS) is not just a tool for enhancing efficiency and reducing errors—it is a critical component in ensuring your lab remains compliant with the ever-evolving regulatory landscape. By effectively managing access, auditing, data integrity, and transmission security, an LIS helps safeguard patient data and provides the necessary documentation to satisfy regulatory requirements. Investing in a high-quality LIS is an investment in your lab's future, protecting it from potential regulatory pitfalls while also streamlining operations. For more insights on how to choose the right LIS for your lab, explore the Managing a Laboratory: Why Your LIS Matters webinar.
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