Clinical laboratory stewardship encompasses both patient safety—with its emphasis on choosing the right test and interpreting it correctly—and financial responsibility. CLN managing editor Bill Malone interviewed Jane Dickerson, PhD, director of reference laboratory services and associate director of clinical chemistry at Seattle Children’s Hospital, and Brian Jackson, MD, MS, vice president and chief medical informatics officer at ARUP Laboratories about this emerging concept. Both are members of Patient-centered Laboratory Utilization Guidance Services (PLUGS), a multi-center collaboration aimed at improving laboratory test ordering, retrieval, interpretation, and reimbursement. PLUGS commissioned the National Committee for Laboratory Stewardship. There are 10 members on the committee from seven academic institutions representing reference laboratories, health systems, and pediatrics. Dickerson and Jackson are two of the co-authors of a recent article about this topic in The Journal of Applied Laboratory Medicine (doi: 10.1373/jalm.2017.023606).

Transforming “utilization review” into “stewardship” sounds provocative. What is the motivation behind this rebranding, or are these terms actually separate things?

Dickerson: Utilization management, and the related term utilization review, have been the traditional words used to describe a health system’s efforts to ensure the right patient is receiving the right test at the right time—and at the right cost. The same term is used by third-party payers.

The problem is that care providers often react negatively to the term utilization management. It brings up thoughts of rejection of their care plan, mind-numbing insurance company bureaucracy with endless phone calls and paperwork, and uncomfortable conversations with angry patients who have to pay out of pocket for an uncovered test. Providers see utilization management as being too heavily weighted toward reducing costs. Their perceptions are partially based in truth as there are many examples—most recently with blanket non-coverage decisions for medical exome testing—in which cost-cutting efforts have been enacted thoughtlessly.

At the same time, the focus on costs has a positive side: Utilization management is responsible for blocking the worst abuses in the laboratory industry, such as current fraudulent schemes to push unnecessary urine toxicology testing. Either way, perception matters and sometimes limits the effectiveness of utilization efforts.

Stewardship is a better term that keeps the idea of careful management, but also brings to the surface the fact that patients—and financial resources—are entrusted to our care. The term also has growing credibility in medicine, such as with the antimicrobial stewardship movement.

With stewardship, the value of laboratory testing is viewed from the perspective of both the individual patient and the population. For example, take the case of an expensive sendout test with limited clinical utility that is not covered by insurance. If this test is performed on a patient who cannot afford it, the test will often dock the laboratory’s budget. Without proper stewardship, these unnecessary tests are a blow to the lab’s ability to deliver necessary services for all patients.

What do lab and hospital leadership need to know about starting or improving their own lab stewardship programs?

Dickerson: Similar to the core elements in antimicrobial stewardship programs, there are four basic elements to consider: 1) governance, 2) interventions, 3) data extraction and monitoring, and 4) strategies for improvement.

Governance includes leadership commitment, committees and subcommittees, and laboratory expertise coupled with clinical support and networking. The obvious place to begin is to put together a multidisciplinary laboratory stewardship committee. This committee should be linked to leadership by including the chief medical officer and chief financial officer (CFO) or their designees as key members.

The CFO is particularly important as the committee may decide that a test that is not covered by insurance still is important to the practice. This generally requires budgetary approval if the practice is going to absorb the cost. The Clinical and Laboratory Standards Institute just published a new report, GP49: Developing and Managing a Medical Laboratory Utilization Management Program, which includes helpful details on putting together successful stewardship committees.

The meat of laboratory stewardship is the interventions it brings to improve utilization. Committees are meaningless if they don’t actually do anything. Critically, interventions must be measured. I like to grade interventions by their effectiveness: weak, medium, or strong. Take creatine kinase-MB (CK-MB) testing as an example. A weak intervention would be using a pop-up or a printed guideline on the requisition to educate providers that CK-MB is no longer recommended in the work-up of a myocardial infarction. A medium intervention would be hiding the test within the CPOE or removing it from the printed requisition. Creating a hard stop in the CPOE that never allows CK-MB to be ordered would be the strongest intervention.

Data extraction and monitoring refers to accurate mining and analysis of data to measure several interrelated factors: the appropriateness of laboratory orders, the retrieval of test results, the appropriateness of test interpretation, and the impact of interventions on all of these. Data on test retrieval and test interpretation are more challenging to collect and may require some level of manual review. It is important for labs to consider their data needs upfront and make a plan before implementing interventions—that way they will have clear criteria for success.

The last element—strategies for improvement—refers to creating a robust process to review and improve your stewardship program. This includes setting criteria to prioritize and select candidates for interventions and ensuring that they reflect institutional priorities. The committee also needs a process for dealing with barriers that impede the projects’ success. Being nimble and able to make real-time adjustments to the program helps maintain momentum.

Imagine a gradient within each of these four areas—success takes time. But it is important to build the program with these four pillars from the beginning, recognizing that there will always be room to grow. I encourage laboratorians to start small. For example, take an obsolete test off the menu or review for medical appropriateness test orders that cost more than $5,000. Then use early wins to garner the institutional support required for more challenging interventions. Just about anyone with advanced training in laboratory medicine can do it.

Balancing the interests of patients, labs, insurers, and providers can be challenging. What role might a lab stewardship committee play especially in the era of value-based payment models?

Jackson: If value-based healthcare payment is to succeed, we will need to learn how to manage healthcare from the bottom-up rather than just top-down. Clinician-led stewardship committees are the best positioned for effective leadership on this because they understand clinical nuance. For them to be successful, though, they need to have buy-in from patients, healthcare delivery organizations, and payers. This requires lab stewardship committees to be science-based, patient-centered, and completely transparent in all they do.

Most modern attempts to manage healthcare from the top down have ended up in a mess of conflicts among all the different stakeholder groups. Some approaches, such as pharmaceutical benefit management companies, result in truly crazy arrangements in which doctors and patients have to jump through all kinds of hoops and still can’t predict what’s likely to be approved or what it might cost. This destroys trust and prevents productive collaboration among payers, providers, and patients.

A realistic, short-term goal—given that the current payment system for ambulatory tests has a strong fee-for-service component—is a bottom-up alignment between payers and labs. This alignment means that clinical lab stewardship efforts, based within a healthcare system where the patient is seen, provide the evidence for the medical necessity of lab testing. In turn, the healthcare system and insurance companies would use the same medical necessity policies and there would only be one process to approve a test.

That approval process would be near the patient, inside the healthcare delivery system, and accepted by the insurance companies, which would have a right to audit the system for conformance to policy. The patient would know during the office visit what test is being ordered, why it is being ordered, when the result will be available, whether the test is a covered benefit, and what the out of pocket expense will be.

In the medium and long term, the current fee-for-service system will decay significantly or go away. My hope and belief is that the U.S. healthcare ecosystem can find fundamentally better ways of paying for lab tests. The obvious example is full capitation, under which laboratory stewardship committees would be even more important. For example, they would have to be much more active in policing both overutilization and underutilization of lab tests. Additionally, in this scenario, laboratory stewardship efforts could support team-based diagnostics where laboratory professionals form formal diagnostic teams with care providers.

But even if fee-for-service survives in some form, I hold out hope that with some creativity, there might be ways to make “medical necessity” less bureaucratic and more personalized to specific patient needs. As it stands, the current approach to medical and administrative policymaking leaves out too many patients who would benefit from appropriately chosen but advanced approaches to testing while also failing to reward valuable team-based approaches to diagnostics.

Jane A. Dickerson, PhD, DABCC, is co-director of chemistry and director of reference lab services at Seattle Children’s Hospital. +Email: [email protected]

Brian Jackson, MD, MS, is vice president and chief medical informatics officer for ARUP Laboratories, and associate professor of pathology (clinical) at the University of Utah in Salt Lake City. +Email: [email protected]

CLN's Patient Safety Focus is supported by ARUP Laboratories

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