Diagnostic Information

Vol. 21 • Issue 12 • Page 24

The last several years have brought a cascade of changes in the world of healthcare, and we are only beginning to scratch the surface of healthcare reform. A deluge of federal regulations dot the healthscape – the Accountable Care Act (ACA), the American Recovery and Reinvestment Act (ARRA), Health Information Technology for Economic and Clinical Health Act (HITECH) and meaningful use (MU). These enactments have led to the rampant restructuring of healthcare facilities into newly formed entities such as patient centered medical homes (PCMHs) and accountable care organizations (ACOs), kick starting a trend of physicians transitioning from owners to employees via the larger hospital entities who are buying or merging with specialty practices.

On top of these structural changes, the future of molecular and genetic testing, companion diagnostics and personalized medicine are impacting the lab. Within this cascade of changes, the future of the laboratory and the role of diagnostic informatics look to be very noteworthy. The perfect storm of government regulations, economic hard times, advances in diagnostic testing, and the pressing need for healthcare reform has converged to create opportunities for laboratories to serve as a key entity in the evolution of healthcare.

An Essential Component

Keith Kaplan, MD, CIO at Celligent Diagnostics and a pathologist at Carolinas Pathology Group, commented, “There is a commonly held principle called ‘The Rule of 70s’ that states 70% of patients are served within a healthcare system by the laboratory, 70% of critical clinical decisions are made based on laboratory test results and 70% of clinically relevant information within the medical record is laboratory data, all while the laboratory accounts for less than 10% of healthcare expenditures. This is a lot of bang for the buck when it comes to that ‘black box’ from which results come.”

Undeniably, the laboratory is an essential piece of the healthcare puzzle; in fact, it’s the piece that provides more objective clinical data than any other area of healthcare. Because the laboratory produces the majority of the clinical data used to diagnose and treat patients, the healthcare changes that revolve around how data gets to the right place at the right time and to the right person involves the laboratory. Therefore, the laboratory’s input and diagnostic information it generates is essential to the success of healthcare reform.

Along Comes Change

A fundamental change in medicine is taking place. As we move away from fee-for-service reimbursement where more service is more money to a world where providers are compensated based on reducing cost and improving the quality of care, what impact can laboratories have on these outcomes? How does the future of laboratory ðmedicine ðcontribute? What is the role of the LIS and all the diagnostic information produced? And how do we, as laboratorians, weather this and control our destinies?

With these changes, diagnostic information becomes even more important as we collectively strive to improve our healthcare system. Healthcare providers can’t reduce costs, improve patient outcomes or develop specific detailed treatment plans if the lab isn’t involved in helping create the framework for those tasks. Laboratories can provide support to ensure that diagnoses are made more efficiently and that providers are given the tools to succinctly pinpoint the best possible therapies. These processes are the goal for the patient to receive the best healthcare and simultaneously reduce healthcare costs. Accomplished, proficient laboratories will drive this necessary change.

Kaplan explained, “By interpreting tests in the context of other tests, genomics, population data, clinical state and time, the laboratory will be able to provide more valuable, more actionable clinical information than ever before. These interpretations will be done by the lab and will look and act like tests. The lab will become a decision support engine feeding the EHR.”

To move healthcare toward being both patient-centric and cost-conscious, providers will need support from the lab to keep up with the increasing barrage of newly added diagnostic testing. This will include guidelines that not only make lab test ordering more efficient and reduce unnecessary testing, but also provide best fit treatments based on diagnostic outcomes, supporting the future of personalized medicine.

Expanded Tools

As healthcare restructures and transforms, the tools provided by the LIS are crucial to the expanded role of the laboratory and diagnostics. The LIS has historically been a workflow manager and a lab data integration tool that sends information to other systems. It must evolve to be a more sophisticated decision-making and diagnostic analysis platform, or a Diagnostic Information System (DIS), that includes the ability to handle integrated diagnostics from multiple areas of the laboratory. All this must happen if the DIS is to facilitate the positive movement toward matching a specific disease state to the most appropriate and cost efficient patient treatment and therapy, i.e., personalized medicine. However, will all lab systems be able to evolve to meet these expanded diagnostic requirements?

Bruce Friedman, MD, active emeritus professor at the University of Michigan, said, “The fact that we are seeing the larger ‘enterprise-wide solutions’ having an increasing dominance in EHR software will have a major impact on the LIS vendors unless they push back.”

An effort to streamline the integration of disparate systems sometimes trumps the advanced functionality needed in the laboratory; some larger hospitals are choosing to adopt the laboratory module of the “all-inclusive” EHR solution.

Friedman continued, “There are some ramifications, as well, behind decisions for LIS software increasingly being moved to the C-suite.” With LIS decision purchases more frequently being made at the administrative level, particularly in larger facilities, the decision process can be removed from the actual needs of the laboratory to a purely financial decision unless laboratorians are involved.

Raymond Aller, MD, clinical professor and director of Informatics at the University of Southern California Pathology shares this concern: “Health system leadership that views the world in an oversimplified way assumes all LISs are of equal effectiveness and productivity, and that buying all health system information technology from a single mega-EHR provider will somehow provide better results than connecting an optimized LIS with an optimized EHR. There will be a growing market for focused, dedicated LIS vendors to replace failed EHR ‘LIS’ modules, as health systems finally recognize that not only does the lab produce 70% of objective data in the EHR, but the complexity of the systems necessary to effectively, efficiently and intelligently produce that diagnostic information far exceeds the relatively simple workflow inherent in a typical EHR implementation.”

Intellectual Capital

Simeon Schwartz, MD, president and CEO of WESTMED Medical Group in White Plains, N.Y., anticipates “a growing importance of imbedded analytics. The LIS vendors have access to extensive lab intellectual capital and this has not been the priority of the EHR vendors. This may be the most important differentiator in the next generation products.”

An enterprise-wide solution may not provide a fully robust anatomic pathology (AP) system. And as the case volume increases, so does the need for more sophisticated technologies and functionality.

EHR vendors have their hands full, particularly with the latest Stage 2 final rule release for meaningful use. Michael Glant, MD, medical director at Orchard Software stated, “Current EHR systems are largely immature and lack the analytics of LISs and various middleware systems. Because of this you may find EHRs depending on labs to explain or format results in a way that clinicians and patients can use and understand. EHR vendors haven’t had the time to focus on the lab module and develop the level of functionality that a strong best-of-breed LIS can offer.”

Generally in the EHR, providers are given a test list, accessible from the patient chart, to select lab order choices. These scenarios offer no educational aspect or best test utilization recommendations. Based on the patient diagnosis and tests selected, an advanced system (EHR or LIS) could provide an educational aspect at the time of order entry and in conjunction with result delivery.

Kaplan suggested an alternative: “During order entry, the appropriate order entry question or entry menu might ask the ordering provider, ‘Do you really want to order this or do you mean XYZ?’ The idea of semantic ordering, consideration of a problem list or list of symptoms, may generate an appropriate list of tests to order that are facilitated and reported through the lab system. Someone who presents with chest pain when ordered into the EHR may pull up a list of suggested lab tests. This is not to suggest that this will drive standardization, but rather develop best clinical practices, appropriate test utilization, and facilitate appropriate tests to ensure the right care on the right patient at the right time.”

“Automation, artificial intelligence and reasonability checks within all systems will be needed and that can only be done with the highest quality of data,” Glant said. “Successful LISs will need to incorporate improved analytical capabilities with decision support technology as well as automated education and training regarding test ordering.

“These systems will need to be able to build integrated reports for both physicians and patients with an educational aspect when desired,” Glant added. The names of laboratory tests can be confusing, overlapping and replete with repeating acronyms. The obvious benefit to this educational aspect would be to alleviate confusion, reduce ordering of inappropriate or unnecessary tests and facilitate appropriate timely follow-up and care management.

Kim Futrell is products marketing manager, Orchard Software.

Must-have Features of Today’s LIS

Regardless of where it’s implemented – in a community or regional hospital, university medical center, or a subspecialty or full-service reference lab – today’s robust LIS will include the following “must have” features:

• Batch Sign-Out

• Batch Image Capture

• Multi-modality Reporting

• In-house Specialty Lab Support

• ICD-10 Compliance

• Synoptic Reporting

• Electronic Cancer Checklist

• Data Mining

• Electronic Requisitions

• EMR Module Certification

• Meaningful Use Stage One Compliance

• Microsoft Gold ISV Competency

• HIPAA Compliance

• Best-of-Breed

• Seamless Integration to Enterprise-wide Vendors’ CP/AP Systems (interface)

• Extensive Outreach Modules

• Interface to Hardware such as Flow Cytometers, Printers, Immunostainers, etc.

• Molecular, Flow &Cytogenetics Reporting

Information provided by Rick Callahan, vice president of Sales & Marketing at NovoPath.