With the current focus in the clinical laboratory industry—and health care as a whole—shifting from volume– to value-based reimbursement, clinical laboratories must promote appropriate and effective test ordering. Historically, laboratories have followed an unspoken rule that what is ordered must be performed, no questions asked. However, as an integral part of a patient-centered care team, the clinical laboratory is obligated to identify and eliminate incorrect, redundant, or unnecessary orders. To accomplish this, the lab should focus on eliminating the just run it mentality.
Reference laboratories face specific challenges in recognizing and justifying this change as they are once or even twice removed from the patient. Without direct access to providers and electronic medical records (EMRs), the reference laboratory must work collaboratively with the ordering laboratory to inquire about potential repeat or duplicate testing issues. Justifying the cancelation of ordered tests is complex in a reference testing setting, as volume drives revenue. However, as ordering laboratories make the transition to value-based testing, it is imperative that reference laboratories follow suit.
Sonic Reference Laboratory (SRL) is a CLIA-certified and CAP-accredited laboratory specializing in analytical chemistry, molecular, hematology, immunology, and clinical chemistry testing. Founded in 2014, SRL delivers high quality test results through a best practice quality management system framework, ISO 15189 conformance, and Lean Six Sigma practices.
The administrative team at SRL determined that an enhanced laboratory information system (LIS) could facilitate robust identification, tracking, and trending of repeat testing and duplicate orders. The laboratory director of SRL identified and deemed specific repeat test scenarios as wasteful and medically unnecessary. Logic rules were created in the LIS to recognize patients with historical results for the test ordered (see TABLE 1A).
Seven tests were identified as medically unnecessary to repeat in a patient’s lifetime. These seven tests are currently flagged by the LIS to eliminate repeat testing:
Once flagged by the system, an inquiry is made with the ordering lab and test cancellation is confirmed or justification is given if the provider requests to proceed with testing. During the 17-month period between December 2014 and May 2016, SRL evaluated its results utilizing LIS logic as part of a process improvement initiative.
SRL created automated test deletion rules to prevent unnecessary testing from being performed and reported in duplicate. For example, HIV viral load testing may be ordered to report as simply a quantitative value or a combination value and additional qualitative interpretation. In the event that these two tests are ordered together, the logic rules in place will delete the value-only test, leaving the parent test in place (see TABLE 1B).
Repeat test cancellations and duplicate order deletions are tracked through the LIS and a monthly report is generated and provided to the ordering laboratories. The data also are analyzed internally and evaluated for trends and potential opportunities for improvement. Lost reimbursement savings are estimated based on the set price of the test and the volume of test cancellations.
Of the seven tests identified as medically unnecessary to repeat in a patient’s lifetime, the highest number of cancellations occurred for Factor V Leiden at 116 tests. The highest number of repeat test deletions based on percent of tests ordered was Prothrombin G20210A with 1.39% cancelled over the 17-month time period (see TABLE 2). The most significant potential lost reimbursement savings for repeat test cancellations was attributed to HCV Genotype deletions, with $5,700 saved. Interestingly, the HCV Genotype rule was not in place for the entire 17-month timeframe evaluated. Due to client feedback, the initial rule in place to recognize repeat HCV Genotype tests was modified to evaluate only repeat testing within 90 days of the current order. The HCV Genotype rule was reinstated in March 2016; therefore, the lost reimbursement savings from repeat HCV Genotype testing represents only 2 and a half months of automated data—March, April, and half of May (see FIGURE 1). Repeat HCV Genotype testing recognized up to this point occurred manually; a difficult process compared to automated recognition, which captured many more repeats in those 2 and a half months than the entire remaining time of the study.
The category with the highest number of duplicate tests deleted was HCV testing, which included three distinct tests: HCV PCR QN; HCV PCR QN/QL; and HCV PCR QN flx Geno. A total of 554 duplicate HCV tests were deleted over the 17-month period evaluated. This category also represents the largest amount of lost reimbursement saved from duplicate order deletions at $42,104 (see TABLE 3). The category with the highest percent of test orders deleted was von Willebrand testing, with 3.22%. Of the 5,474 von Willebrand tests ordered over the period evaluated, 176 tests were deleted. This category includes four distinct tests: von Willebrand Panel, Factor VIII Activity, von Willebrand Factor Activity (Ristocetin), and von Willebrand Factor Antigen.
Over the 17-month period, SRL reduced test overutilization by 0.26% of the total testing volume, which equates to 1,419 tests—471 repeat test cancellations and 948 duplicate order deletions (see TABLE 4). This represented 0.77% of tests ordered with applicable repeat testing flags and 0.44% of tests for which duplicate ordering rules were defined. The average monthly savings realized for repeat test cancellations was $1,595 and $3,005 for duplicate test order deletions. This equated to a total of $78,193 in lost reimbursement savings over the 17-month period evaluated.
Although the reduction in overutilization represents a relatively small fraction of the total test volume over the 17-month period measured (0.26%), the resulting lost reimbursement savings through the elimination of medically unnecessary repeat and duplicate test orders was significant ($78,193). Spikes occurred when new tests were brought online or when new rules were implemented in the LIS. The overall trend is an increase in deletions and cancellations that correlates to an increase in total testing volume (see FIGURE 2).
As the number of months SRL was in operation increased, the number of recognized repeat tests likewise increased (see FIGURE 2). A potential cause could be patients switching health care providers over time without transferring historical test results. However, when the data are analyzed as a percent of total tests cancelled, as shown in FIGURE 3, there appears to be an overall downward trend post-June 2015. The trend appears to be even more significant beginning in January 2016, which marks SRL’s introduction of monthly test utilization reports to its ordering laboratories. Based on these data, it is clear that an effective feedback loop is critical for successful reduction in test overutilization.
It is worth noting that the LIS may not be catching all medically unnecessary repeats due to multiple instances of the same patient in the system. The basis for the logic rules is a unique medical record number (MRN); when more than one MRN is associated with a single patient, the LIS will not recognize the newly ordered test as a repeat. An enhanced system for recognizing and eliminating duplicate patient records in the LIS is the next step toward fully identifying all medically unnecessary repeat tests. The necessity for new repeat testing flags and duplicate order deletion rules must be carefully considered upon test menu expansion.
As the laboratory industry navigates changing reimbursement models and strives to become more patient-centric, effective tracking, communication, and correction of inappropriate utilization patterns will become critical to the laboratory’s success and sustainability. Affecting test utilization at the reference laboratory level can prove to be particularly challenging due to the lack of patient history, including justification for ordering as well as information about laboratory tests previously performed, and lack of access to and collaboration with ordering providers. The data presented in this paper clearly demonstrate that the use of LIS logic is an effective method to combat inappropriate test utilization and subsequent financial loss caused by medically unnecessary repeat and duplicate test orders.
Melissa Hiserote, MS, PMP, is the director of projects for Sonic Reference Laboratory (SRL) in Austin, Texas. Melissa was a member of the core team responsible for establishing the new laboratory, which opened its doors on December 1, 2014. She is responsible for managing the test development pipeline and ensuring effective communication of new test launches. Melissa serves on the board for the Austin Chapter of the Project Management Institute.
Jennifer Dawson, MHA, LSSBB, CPHQ, DLM(ASCP)SLS, QLC, QIHC, is the vice president of quality and regulatory affairs for Sonic Reference Laboratory (SRL). Jennifer built SRL’s quality program from the ground up embedding ISO 15189 conformance, and is responsible for oversight of a strategic approach to a robust, best practice quality management system and regulatory compliance for the lab. She serves on the CLMA Board of Directors, the ASCLS Patient Safety Committee, the CLSI Expert Panel on Quality Management and General Practices, and the National Malcolm Baldrige Quality Award Board of Examiners.
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