It’s time to redefine the LIS

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In 2018, it looks like the traditional definition of a laboratory information system (LIS) will become increasingly obsolete. Nearly everything about the laboratory landscape is in flux, including reimbursement models, diagnostic methods, and healthcare market consolidation—and the changing LIS will play a role in all of these.

However the current trends in the clinical lab industry develop, one thing is clear: laboratories can no longer afford to be the hidden workhorse in the hospital basement. Laboratories that succeed in this unpredictable environment will be those that engage fully as a vital, visible part of the healthcare delivery system.

To do so, they will need information solutions that go beyond basic order capture and results delivery to ensure flexibility across and beyond their network, promote scalability and efficiency, and enhance the lab’s value as a revenue center and care partner.

Ensuring flexibility in changing networks

Mergers and acquisitions continue to dominate healthcare trends, having grown steadily since 2009.1 This trend is reconfiguring the networks in which labs provide services and share information. As healthcare providers consolidate, organizations confront an assortment of poorly integrated IT systems. There may be a temptation to consolidate on a single platform by replacing independent laboratory software with an enterprise-wide system and a laboratory module.

For labs facing this decision, the choice is not really one of a stand-alone LIS vs. the LIS built as part of an EHR. In the current healthcare landscape, “stand alone” is a misnomer. Traditional laboratory information systems no longer cut it. The landscape shift is demanding that technologies change, to become laboratory information solutions. These systems have the ability to connect across the diagnostic process, with instrumentation and middleware as well as lab management analytics, physician EMRs, enterprise software, or population health tools. An LIS that is an afterthought in an enterprise EHR is unlikely to expand the lab’s ability to network in the healthcare community or enhance its diagnostic offerings as new options develop.

When laboratories choose information solutions, they should consider whether those solutions provide sufficient interoperability to interface with an ever-changing spectrum of healthcare entities and complementary technology. Replacing an LIS may be cost-prohibitive, leaving labs with inadequate connectivity cut off from growth opportunities.

Promoting scalability and efficiency

In this environment, laboratory informatics must expand beyond excellent management of inner analytic workflow to support and manage pre- and post-analytic workflow as well. For example, another decision consolidating healthcare organizations must make involves utilization of multiple hospital labs. Faced with more labs than volume, some may close underperforming sites and choose to outsource. A more profitable alternative is a multi-lab collaboration, with tests routed according to factors including instrumentation, payer rules, or test load capacity.

Supported by integrated customer relationship management, courier and specimen tracking, automated test sharing and routing, and consolidated results reporting, laboratories can work together to bring more testing in-house—from hospital inpatients and outpatients, outreach, and other sources. A LIS that can integrate at this level and carry it through at the instrumentation level promotes patient safety and lab efficiency.

That efficiency also extends to utilization issues such as test duplication, incomplete orders, or the absence of advanced beneficiary notice, which can more easily lead to larger problems, including treatment delays or write-offs for tests not reimbursed. The Institute of Medicine estimated the average cost of unnecessary lab work at $1.7 million per hospital annually.2 Laboratory information solutions that ensure connectivity between labs and physicians, and among labs, can provide order optimization and clean order capture to avoid common costly issues and delays in delivering the most efficacious patient care.

Growing the lab as a revenue center and care partner

Emphasis on consolidation and utilization puts pressure on laboratories to demonstrate their value among care providers. Other trends, however, suggest that laboratories have multiple opportunities to increase the services they provide. For example, as the population ages, the number of tests may rise exponentially. Currently, patients over age 65 require five times the number of lab tests as those under age 65,3 and the number of patients over 65 will continue to swell as Baby Boomers grow older. Similarly, the number of patients diagnosed with chronic diseases and conditions, such as diabetes or diseases of the heart or kidney, has continued to grow. Appropriately utilized testing will play a role in both early identification of these conditions and ongoing treatment to keep them under control, minimizing ED visits and promoting patient wellness among high-risk populations.

Pharmacogenomics, genetic testing and other forms of molecular medicine have taken major strides into the mainstream. Somatic testing has become increasingly common for cancer treatment, and the FDA has recently approved a gene therapy that can reverse a form of inherited blindness.4 The potential of personalized medicine to cut costs and enhance care by finding the most effective treatments suggests that it will continue to have a high growth rate.

Labs poised to take advantage of these trends will be those who can handle the higher volume. Innovative laboratory information solutions can support this with efficient workflows as well as decision-support capabilities for both test analysis and lab management throughout the enterprise. Labs equipped for esoteric or molecular workflows, analysis, and reporting will offer especially high value to their healthcare community.3 Bringing these tests in-house rather than outsourcing saves substantially on send-outs, as costs grow 12 percent to 50 percent each year.5

Putting the pieces together

Genomic medicine provides an excellent example for how the LIS of yesterday will need to grow to become a full-fledged LIS, from ensuring complete orders to delivering usable results with demonstrable value. The rapid growth of genetic testing makes expanding molecular capabilities an attractive option for labs; a robust information platform can make it viable.

When a physician orders a set of tests, those tests could be routed to multiple labs handling esoteric, anatomic, and molecular testing separately. Flexible multi-lab networking ensures that patient information is consistent and specimen tracking remains integrated, as well as provides a centralized administration of test catalogs for less IT hands-on management. Though one or more labs may not be onsite, a utilization optimization tool can provide an alert if a test lacks appropriate preauthorization to ensure payment, or, more importantly, if the right test is not being ordered on the patient at the right time. Through the network, the lab can also acquire an ABN or other statement of medical necessity before proceeding.

A LIS/LIMS (laboratory information management system) that accommodates molecular workflows and complex specimen tracking will allow a lab to scale genetic tests and other molecular processes efficiently, without disrupting current workflows. Genetic analysis tools that streamline interpretation and automate much of the report writing allow labs to deliver clinically actionable reports in a fraction of the time. Direct connections to other laboratories provide clinically validated variant information in real time, so physicians and patients have the benefit of the most current findings. Ease of integration makes it possible to scale molecular diagnostics without dramatically increasing personnel or lab space. For multi-lab orders, molecular and anatomic results can be combined into one coherent report, which can then be delivered directly into the EMR for the physician and patient.

As genetic knowledge evolves, the data maintained by the lab continues to be valuable for years to come. Should a variant of unknown significance be determined to be pathogenic, all specimens containing that variant can be tracked to their initial ordering physicians. An automated alert can reach the physician directly for further action, so patients can be assured of optimal care.

No technology will be a magic bullet for the challenges in healthcare today. But comprehensive laboratory information solutions and vendor support specifically geared to laboratory needs in this changing environment will dramatically increase a lab’s chances of success.

REFERENCES

  1. KaufmanHall. Hospital merger and acquisition activity continues to climb, according to KaufmanHall analysis.
  2. Smith M, Saunders R, Stuckhardt L, McGinnis JM, eds. (Institute of Medicine of the National Academies). Best Care at Lower Cost: The Path to Continuously Learning Health Care in America. Washington DC: National Academies Press, 2013.
  3. Cain Brothers. Strategies for healthcare leaders: medical labs and diagnostic testing: a growing value proposition.
  4. FDA news release. FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss. December 19, 2017.
  5. Burns J. Health insurers struggle to manage number, cost of genetic tests. Managed Care. April 19, 2016.
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