CHICAGO (360Dx) – Many molecular laboratories have laboratory information systems that fall short of even the most basic requirements, according to a recent article published in the Journal of Molecular Diagnostics.
In it, the researchers described shortcomings that they found in bar coding, the ability to interface with lab instruments and electronic health records, storage of preanalytical data, outcomes reporting, and compliance with HIPAA security rules that have been in place for nearly a decade and a half.
"Without adoption of common standards for health data transmission that include a full [Health Level Seven International] messaging interface, interoperability with other laboratory information systems and electronic health records may fail as well," the authors wrote, adding "Laboratories in this situation are then still reliant on paper, flash drives, and other means of data transfer to get results into a report."
Corresponding author Alexis Carter, physician informaticist for the pathology lab at Children's Healthcare of Atlanta, said that her lab takes multiple steps to get data into the LIS and assure that the information is accurate.
"Typically, multiple people are checking," resulting in a far more labor-intensive process than if systems were more tightly integrated, she said.
These "functionality gaps," the researchers added in the paper, have only increased in the age of next-generation sequencing.
"The concern for me as a molecular pathologist is that molecular testing is skyrocketing in volume," Carter said, citing statistics from the paper that suggest general labs are seeing their volume increase by 2 to 4 percent annually, while molecular labs are dealing with volume increases of 15 to 20 percent per year.
"At some point we are going to reach this point where we simply just can't … take on more volume because we don't have the infrastructure to support it," Carter said. "The biggest concern, obviously, is accuracy."
Genomics presents some of its own challenges. For example, in a pathology report, most people will be able to reason that "adenofarcenoma" transcribed in the report is supposed to mean "adenocarcinoma" and let the pathologist know.
"But if you are reporting [the gene mutation] L858R as an L858L, that's a completely different connotation, and it might raise eyebrows, but it might not necessarily be recognized as an error," Carter explained. "Those types of mistakes are significant but even harder to recognize."
In a survey of 34 questions returned by 80 professionals in US molecular labs for the study, Carter and her colleagues found that breakdowns in LIS workflows occur for a variety of reasons, including a lack of instrument capabilities. Just 12.5 percent of respondents reported that their instrumentation could electronically transmit raw data to their LIS. "This means that current workflows largely require the use of one or more paper media, transcription, and/or copy-paste to transform raw result data into a report for sign out," the authors wrote.
Even many modern molecular LISs lack tools for "effective report generation," the article said. Only about half of respondents said that they could populate reports with discrete data from their lab systems. "In fact, when asked what people loved or hated about their LIS, the most common answer in either direction dealt with reporting," according to the paper.
Another major area of concern is the ability of LISs to comply with HIPAA even though the final privacy rule took effect in 2004 and the security rule about a year later. The standards did undergo some modifications in 2013 with the HIPAA Omnibus Rule, which, among other things, included genetic data as "protected health information" that is subject to HIPAA protections.
Less than 20 percent of respondents in the study survey said that all instruments in their labs have unique user names and passwords, which HIPAA requires. According to the researchers, the reasons for this differ, but they found that several instrument manufacturers have made it "impossible " to create a user name or password, while other instruments aren't able to handle more than one or two generic logins and passwords in the instrument software.
Some device makers require all users of a specific instrument to share a preset login and password, a setup that makes it impossible to have the type of audit trail that HIPAA mandates.
And end users rarely demand such features in their LIS technology. Whenever Carter asks for more security, vendors "frequently tell me that I am the first person who has ever asked them about this," she said, noting that instrument software vendors often are small and do not have compliance departments on the scale of, say, EHR vendors.
"Most of the reports of this fundamental lack of functionality really is more on the instrument software side," Carter said. She declined to identify who they are but said some are "pretty big-name vendors in the field."
Laboratories, even those within health systems, often are left on their own to ask such questions when purchasing technology. "If they didn't have somebody who knew to ask those questions, then they ended up purchasing things based on their functionality, and not necessarily based on some of these other components," Carter said.
While the findings may be concerning, Carter is optimistic that the paper will serve as a wake-up call to the industry.
"I'm really hopeful that the paper will be useful not just for laboratorians, but also for vendors, to educate them and to try to help bridge that gap of communication as to what laboratorians actually need, not just from a functionality perspective, but also from a compliance perspective, and then to give vendors an idea of where they might focus some of their development," Carter said.