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​Literature Search Executive Summary with committee members
Prepared by: Diane Davis, Denise Geiger, Roberta Madej, Teresa Nadder, Paramjit Sandu, Robert Schmidt, Steve Zibrat

This report provides a narrative review of the current literature published from 2000 to 2015 on the value of laboratory medicine and presented to the CCCLW to contribute to their goal of identifying measures that would potentially tease apart the value of laboratory medicine from other health care services in achieving desired outcomes. The organization of the report is based on the perspectives of the following stakeholders of clinical laboratory services:

• Clinicians
• Patients and family members
• Parent organizations
• Healthcare systems
• health
• Pharmaceutical Industry
• Centers for Medicare & Medicaid Services

The working definition used in the development of this report for the value of laboratory medicine was patient health outcomes achieved per dollar spent. Laboratories affect value by making decisions that affect both outcomes and costs. Unfortunately, most studies on diagnostic tests focus on analytical or clinical performance. Very few studies produce data on patient outcomes except in very narrow situations such as the value of a particular test in a specific clinical situation. Though numerous publications addressed the need to identify strategies for defining the value of laboratory medicine, the literature is sparse with regards to the application of this definition. Common themes across the perspective of the stakeholders as determined by the literature are listed below.
 
Key Findings: Common Themes across Stakeholders’ Perspectives

• Value through providing test results. The 2015 Institute of Medicine’s report on Improving Diagnosis in Health Care notes that over the past 100 years, diagnostic testing has become a critical feature of standard medical practice. In addition to diagnostic information, the clinical laboratory test results indirectly affords value through providing management of and direction for therapy, prognoses, knowledge for research and development, and support for public health. Quality assurance and operational performance support the activity of providing test results.
  • Focusing on patient safety, healthcare professionals are showing increasing interest in the quality assurance of laboratory testing processes especially in the pre- and postanalytical phases of total testing phase (TTP) of laboratory testing. While the laboratory can and should contribute to minimizing these pre- and post-analytical delays, determination of laboratory value must be restricted to that which the laboratory can control.
  • Laboratory medicine must take the lead in developing the studies of not just analytical accuracy but clinical utility that will provide the evidence that a test ordered in specific clinical situations will impact and improve patient outcomes.
  • Faster turnaround time (TAT) is often seen as desirable and has been a common theme in the literature for the past 30 years and cited as the preference that has driven much of the proliferation of point-of-care testing (POCT). Despite this ongoing “need forspeed”, the evidence of improved outcomes that might result from a faster testing process has been contradictory.
• Value through consultation in test utilization strategies. Inclusion of laboratory services on diagnostic management teams (DMTs), tumor boards, and precision medicine consultations, improves patient outcomes and reduces the cost of health care. Studies designed to monitor requests for laboratory consultation and to use the information to identify opportunities for improvement are reported. Significant opportunities exist for laboratory professionals testing within molecular, genetic, and precision medicine to demonstrate value in assisting providers in diagnosing and treating patients with increasingly successful outcomes.
• Financial value. Laboratories operate as a profit center when the hospital receives payments under a fee-for-service arrangement and operate as a cost center under prospective payment systems. In either case, efficient use of resources provides value to the organization. The value of the laboratory has been viewed in terms of the efficiency of the response to test requests.
  • Several different frameworks are available to evaluate laboratory performance and develop metrics for laboratory performance including financial perspective, the functional strategic perspective, the balanced scorecard, and the enterprise performance framework.
  • Ancillary services provide an opportunity for laboratories to escape commoditization and provide value by providing services to improve the effectiveness of testing. Much as manufacturers can increase value by providing services to help customers use their products effectively, laboratories can provide services to improve the effectiveness of testing and to be entrepreneurial with excess laboratory capacity and outreach.
• Value through knowledge development.
  • The evolution of technology, molecular epidemiology, and bioinformatics, collectively, contributed to the rapid increase in value of laboratory services, especially in public health, since the 1960s. The impact on federal regulations from initiation of public health programs conveys value of laboratory medicine.
  • Advanced molecular testing has influenced health care associated infection rates, patient health outcomes, hospital length of stay, number of days in isolation, patient satisfaction, antibiotic stewardship, and health care economics, which can be used as variables to measure the value of laboratory medicine and ultimately influence policy development affecting larger population units.
  • The pharmaceutical industry is becoming increasingly dependent on laboratory tests (precision medicine) in the development of new drugs and the salvage or repurposing of therapeutics that had been abandoned prior to the pharmacogenomics developments. The FDA uses this data as a basis for regulatory determinations.
  • Information generated from population-based surveillance programs enables the Centers for Disease Control and Prevention to develop practice guidelines for the prevention of antibiotic-resistant infections in healthcare settings, in the community, and in food. Dissemination of these guidelines resulted in decreases in health care associated infections. Data collected by laboratory medicine services have provided the impetus for the development of safe vaccines, standardization of methodologies, and providing an environment with less exposure to lead and second-hand smoking.
• Strategic value. Decisions on technology adoption, test menu choices, outsourcing, adoption of point-of-care testing, and design of a laboratory network have significant longterm effects on the organizations capabilities. Cost-saving testing management includes add-on tests, reflex testing/testing algorithms, discontinuing obsolete tests and preventing ordering without consultation. Laboratory services influence adjustments in hospital payments made by Center for Medicare and Medicaid Services for performance in the following quality domains: clinical process of care, patient experience of care, outcome domain, and efficiency domain.
• Value through patient satisfaction. Laboratories are important partners in improving the patient experience. Patient satisfaction is improved when services are offered in off-site convenient places and times. Further, patients are more satisfied when they can access their own lab results from anywhere electronically, and outcomes are likely improved because they become partners in their own health and compliance has been shown to improve when patients can directly access lab results. Clinical laboratory data is used in the Hospital Inpatient Quality Response Program which is intended to provide consumers with quality of care information to be used when making decisions about healthcare options.