Elevating Lab Testing At Policymaking Table

CDC engages Battelle Corporation to identify and publish laboratory medicine best practices

CEO SUMMARY: With the help of contributing clinical laboratories, the CDC has launched an ambitious effort to gather data, apply evidence review methods used in clinical studies, then identify and publish best practices in laboratory medicine. The goal is to advance the value of laboratory medicine. Some lab experts believe this effort may produce the type of credible information that helps lab testing move away from commodity-based pricing in favor of value-based reimbursement.

JUST AT THE MOMENT when Congress and the new administration is prepared to implement radical reforms to the nation’s healthcare system, a credible effort to identify and publish evidence- based best clinical practices utilizing laboratory testing has launched.

If the goal of the lab industry is to educate healthcare policymakers about the incredible value of laboratory testing and move the discussion away from treating a lab test as a commodity, as if it was salt or lumber, then laboratory leaders across the country should take time to learn more about this new effort.

CDC Teams With Battelle

It is the Laboratory Medicine Best Practice Project. At the Centers for Disease Control and Prevention (CDC), the Division of Laboratory Services contracted with Battelle Memorial Institute to identify and publish evidence-based best practices in laboratory medicine. In particular, the project will focus on the pre-analytical and post-analytical stages, which starts when clinicians order laboratory tests and ends when they use the lab test results in patient care.

Battelle is recruiting laboratories to participate in this effort. In one public document, Battelle explains the project:

Systematic evidence review methods are standard practice in clinical medicine and public health, but are rarely applied to laboratory practices in the pre-and post-analytical phases of the total testing process.

In previous work, we adapted these methods to evaluate laboratory medicine practices. Because published evidence for laboratory practice effectiveness is limited, Battelle is developing a laboratory network to reach beyond the published literature. The network will identify and evaluate unpublished studies by laboratory partners that address specific quality improvement, cost, or patient safety issues, using the same rigorous criteria applied to published studies.

“A specific objective of this project is to identify, evaluate, and publish laboratory best practices that meet the standards of evidence-based medicine (EBM),” explained Paul Epner, who is Network Administrator for the Laboratory Medicine Best Practice Project. “This project came about because, at this time, little published literature exists that supports laboratory medicine best practices throughout the total testing process, but especially in the pre-and post-analytical stages.”

Pre- And Post-Analytical

Epner points out that a major objective of this effort is to shift attention away from the analytical step in laboratory testing— which tends to get lots of attention and resources by laboratory professionals. Instead, the project will concentrate upstream, from the point when a clinician decides to order tests and the lab collects the specimens; and downstream, as the laboratory reports the test results and the clinician determines which course of action is indicated for the patient. Published literature indicates that most errors affecting patient safety and outcomes occur in the pre-and post-analytical phases.

“Surveys show that most laboratory managers focus on factory-like measures of performance, such as cost per test, billables per FTE, in-lab cycle time (accessioning to result release), or employee safety and satisfaction,” observed Epner. “Meanwhile, healthcare policy debates focus on clinical and economic outcomes and the factors that drive them.

Improve Outcomes

“A central theme of these debates is the performance of our healthcare system and the incentives necessary to improve outcomes and lower utilization of resources,” he continued. “This debate has led to innovations such as pay-for-performance and evidence-based medicine (EBM). As a source of reform, EBM is intended to reduce variations in care left unexplained by clinical findings and to limit the adoption of new, more expensive and unproven technologies.”

That is why the Laboratory Medicine Best Practice (LMBP) Project has the potential to be a strategic game changer for pathology and laboratory medicine. Many healthcare policymakers view laboratory medicine as a commodity. This perception is a result of the vacuum of evidence-based medicine studies that demonstrate how effective use of the right laboratory test—at the right time with results coming from a valid and reliable process—can significantly improve patient outcomes at minimal cost. Lacking such credible sources of information, many policy makers think of the laboratory as though it were a factory turning out numbers—instead of an essential member of the patient care team.

Sustainable Process

“Laboratory medicine and pathology need a sustainable process for generating evidence-based best practice recommendations in laboratory medicine to improve healthcare quality—and which also have credibility with healthcare policymakers,” observed Epner. “As part of the LMBP project, the methodology for collecting and evaluating evidence was established and a pilot test of the process is underway. One early finding confirmed the lack of sufficient, high quality peer-reviewed literature to determine laboratory best practices.

“The CDC, through Battelle, is ready to help the laboratory profession expand the available evidence,” added Epner. “This will be accomplished by using unpublished data from laboratories that is generated during their normal operations and from their quality improvement projects. Systematic review methods will be used to evaluate the findings and assemble evidence summaries as if they had come from published sources.”

Laboratory managers and pathologists interested in advancing these aspects of laboratory medicine are invited to participate in the project. According to Epner, a lab’s participation will require no extra effort, for an interesting reason.

“Participating labs need only submit data that they already collect!” said Epner. “This makes it easy for labs to participate. Sources can be existing data from retrospective observational studies, case studies, quality improvement projects, and FMEA studies, for example.

“Data will be de-identified with respect to patients and facilities, with only system demographic information being retained for evidence review,” he continued. “Data submission will be accomplished through an online portal at the project’s website (www.futurelabmedicine.org) or through completion of a data form based in Excel. Other than the time required to prepare and submit the data, no other meaningful costs or resources are required for a laboratory to participate.

“The Laboratory Medicine Best Practice Project is expected to advance knowledge in two direct ways,” commented Epner. “One, based on study data and evidence review methods, effective best practices in laboratory medicine will be identified that have demonstrated desirable impacts on clinical outcomes. The nation’s labs can then use these EBM findings to improve and advance the quality of the lab testing services provided by their laboratory.

“Two, the availability of these evidence-based laboratory best practices is expected to open more doors for pathologists and laboratory professionals to participate in high quality clinical research and contribute to the improvement of healthcare delivery in the United States,” he said.

Quality of Lab Testing

As a consequence of the publication of evidence-based laboratory medicine best practices, Epner and his colleagues also see strategic benefit. “The accumulation of these peer-reviewed, credible findings about the value of laboratory medicine is expected to open more doors for laboratory professionals,” he predicted. “It may even reserve a welcome place at the healthcare policymaking table for laboratory medicine.”

THE DARK REPORT observes that this is a unique opportunity for the laboratory medicine profession. Not only is the CDC putting its imprimatur behind this laboratory best practices project, but it is also providing the resources (Battelle Corporation) and the funding! Laboratory administrators and pathologists interested in shifting laboratory medicine away from its “commodity” status and over to an “added value” clinical asset should con- sider participating in this project.

How Labs Can Participate To Identify Best Practices

TO ENCOURAGE WIDE PARTICIPATION by clinical laboratories across the country, the Laboratory Medicine Best Practice Project made it simple to volunteer and simple to submit data.

“Labs can register to become part of the Laboratory Best Practice Network by visiting www.futurelabmedicine.org and completing the registration information,” stated Paul Epner, who is Network Administrator for the Laboratory Medicine Best Practice Project.

“Participating labs are asked to submit data and information that they already collect from normal operations and from their quality improvement projects,” continued Epner. “For this reason, participation requires no additional measurement or data collection by the participating laboratory.

“Data submitted should be patient-dei-dentified. Labs have the option to be individually identified or remain anonymous in published findings of lab best practices,” he added.

The first phase of this project will evaluate and identify best practices in three areas:

    • Reducing patient specimen identification errors
    • Timely, accurate communication of critical laboratory test results
    • Preventing blood culture contamination

For more information: http://www.futurelabmedicine.org

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