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The clinical laboratory has an important and expanding role in ensuring that laboratory tests are appropriately utilized in clinical practice. Laboratories are discovering that they are well positioned to provide medical guidance and direction for clinicians who are trying to maneuver their way through the increasingly complex world of laboratory testing, including genetic-driven diagnostics and therapeutics. There are literally thousands of laboratory tests that clinicians might request as they evaluate a particular patient, but it is difficult, if not impossible, for any one individual to be proficient in all areas of medicine. Because of the number and the complexity of these tests, physicians are realizing that they have gaps in their knowledge and understanding of these assays. In addition to providing guidance to clinicians, test utilization efforts may also be driven by financial realities as laboratories try to rein in laboratory costs or in response to payer programs and policies that reduce payments to providers. Whatever the underlying reasons, the clinical laboratory needs to take the lead in developing a successful test utilization initiative.
So, why the sudden interest and enthusiasm for test utilization? Health care costs in the United States are thought to approach $2.5 trillion per year, and laboratory and pathology testing accounts for $60 billion or about 4% of total health care costs. However, that percentage is increasing rapidly, with some experts estimating that laboratory costs are skyrocketing at a 15% to 25% annual increase. Molecular and genetic assays are driving this escalation, as the explosion of genomic knowledge has led to novel genetic assays for almost any common, or even rare, disease process. This financial burden will clearly become a focus for payers and health care providers alike. It will be impossible to ignore the realities associated with laboratory costs and the need for defining appropriate test utilization.
Test utilization should be defined as a strategy for performing appropriate laboratory and pathology testing with the goal of providing high-quality, cost-effective patient care. A test utilization program must be focused on patient care, ultimately leading to a more efficient and cost-effective laboratory diagnostic approach to answer the clinical questions being asked. A test utilization initiative cannot be driven as a pure cost-control process. If the primary motive is financially instead of patient care driven, then any utilization program will either be short-lived or ineffective in its outcome. High-quality medical practice must be the driving force if a test utilization program is to be successful.
Mayo Clinic has defined the clinical value equation as: Value = Quality / Cost with quality defined as Outcomes + Service + Safety. Clinical value increases when quality (ie, outcomes, service, and safety) is improved and cost is decreased.
This is as relevant for the laboratory as it is for a clinical practice. No matter how we define test utilization, the clinical laboratory needs to understand the critical role it must play in our changing health care environment.
Laboratory professionals need to be fully engaged with the clinical practice in any test utilization process. It is not easy and requires interactions with clinical colleagues that may not always be comfortable. We need to be able to question test requests that come from our clinical colleagues, suggest appropriate tests to answer the clinical question being asked, and cancel test orders when they are inappropriate for the question at hand. Laboratorians must become comfortable and confident in these interactions. Our clinical colleagues have few incentives to order fewer tests, and they certainly are not being trained with that intent in mind. So it becomes the laboratory’s responsibility to identify utilization issues, implement a program that will achieve more effective laboratory testing, and establish processes from the beginning to the end of the testing cycle that lead to a successful laboratory test utilization program.
The biggest questions that laboratories usually encounter when trying to develop a test utilization program are simple: “How do we do it?” and “Where do we start?” That we have these very basic questions emphasizes that no simple answers exist. A successful solution requires a multipronged approach that must involve the clinician, the laboratory, and clinically engaged pathologists and laboratory directors. The key is to understand how the clinical laboratory test cycle works, the roadblocks that invariably exist, and how the laboratory can integrate into these processes and overcome the roadblocks.
A utilization control process actually starts when the clinician begins to consider what tests are needed to evaluate his or her patient—whether for diagnosis, follow-up, therapeutics, or exclusion of disease. Appropriate ordering depends on the clinician having the correct core knowledge to make that decision.
The laboratory enters the process early on as it provides that clinician with the tools to order the correct test. A test-ordering process often varies. The process for ordering clinical tests may be designed to make it easy for the physician to request any and all tests, or it may include prerequisites, requirements, or permissions that the clinician must fulfill prior to placing that order.
After the test order or specimen is received in the laboratory, the laboratory professional can play a more active role in the test decision process. Clinical laboratories are beginning to explore how to use algorithms, test guidelines, and test formularies to put appropriate medical and utilization reviews in place. Instead of taking the easier and passive role, “if the doctor orders it, we do it,” clinical laboratories are beginning to explore how to use algorithms, test guidelines, and test formularies to put appropriate medical and utilization reviews in place.
An overall test utilization control process might look something like this:
At several points along the test-ordering continuum laboratories can influence and change the ordering process.
Preanalytic: Clinician test ordering
Laboratory reports may not be easy to read or understand, leaving the clinician with more questions than answers. While there will be differences in format and presentation, all laboratory reports must contain certain elements as mandated by the Clinical Laboratory Improvement Amendments (CLIA). The report may also need to contain additional items not specifically required, but that can assist the clinician in the interpretation of laboratory test results.
Test utilization management is not a new concept to most laboratories, but few have taken the steps necessary to truly initiate a utilization control process. Every laboratory needs to design its own strategy for test utilization and find what best fits the structure and culture of its institution. Laboratory professionals can position themselves as utilization experts who can assist clinicians with test ordering and ultimately improve the quality and efficiency of patient care. The task is not easy. Conversations with clinical colleagues to gain information, cancel a test, or suggest ordering a different test can be uncomfortable, but these interactions are necessary to build a successful laboratory utilization program that leads to high-quality, cost-effective patient care.
Authored by: Dr. Curtis Hanson and Elizabeth Plumhoff