{'fraction_non_alphanumeric': 0.019953146457710638, 'fraction_numerical': 0.0033928427175054527, 'mean_word_length': 5.478283621140764, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 1, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
In Support of Quality and Safe Patient Care: Defining the Value of Laboratory Medicine

The Coordinating Council on the Clinical Laboratory Workforce (CCCLW) initiated a task force charged with describing the value of clinical laboratory medicine toward the overarching needs of achieving quality patient care and improving patient outcomes. In part, a survey was conducted to discover what clinical laboratories do or should do to achieve these goals. A total of 469 respondents representing various sized and types of facilities, as well as various clinical positions participated. It confirmed that the topic was impacting about two-thirds of respondents who reported pressure from senior leadership to actively show the value of the laboratory. Interestingly, a slightly higher number (69%) indicated they felt constant pressure to cut costs. Open-ended questions were utilized to determine approaches to demonstrating value and responses fell in six categories. Questions also sought approaches to measuring value with responses largely falling within five categories primarily composed of structural and process measures.

Since the goal was to identify all relevant initiatives rather than develop generalizable knowledge, no attempt was made to eliminate multiple respondents from the same institution, nor attempt to use a statistically representative sample.
The survey itself addressed four topics along with the collection of demographic information. A copy of the complete survey is included in the Supplemental Information online (Appendix A).
Initially, questions about health system context were presented that assessed leadership pressure to address value and separately to address cost. Respondents were then asked to describe implemented initiatives that clearly demonstrated the value of laboratory medicine to patients and/or to the larger health system. The question explicitly stated that the initiative could have originated in the laboratory department or in any other department within the system. However, to be included, the value must have been acknowledged by non-laboratorians and the benefits had to be realized by patients or the health system and, if the latter, could not be limited to measures of internal laboratory quality or department-specific cost effectiveness. The third topic sought to uncover measures used to evaluate the impact of this initiative as a demonstration of laboratory value. Finally, respondents were asked to identify "wishes" that, if available, would clearly demonstrate the value of laboratory medicine for both patient and health system outcomes. The final three topics were presented as open-ended questions to be completed in free-text fields.
The open-ended questions were analyzed by an initial full review of all survey responses, which led to the development of categories, sub-categories, and a coding methodology that tied back to the developed taxonomy for each question. A code was only defined if at least two responses could be assigned to it. During a second reading, each response was assigned one of the available codes.

Response to Change
Little more than one-half of the respondents agreed or strongly agreed that a shift from a structured fee schedule to capitated or value-based reimbursement was impacting system strategy and that it will cause a significant change in laboratory operations as shown in Table-1. Over two-thirds of the respondents felt the need to prove the laboratory's value to senior leadership with a slightly higher number indicating the priority was cutting costs.

Completed Initiatives that Demonstrate the Value of Laboratory Medicine
Respondents were asked to provide existing and/or completed quality improvement initiatives which linked the value of laboratory medicine to patient care and well-being. Reported initiatives from 133 coded responses fell into six categories as noted in Table 2. Detailed responses within each category are available in the supplemental information online (Table S-1). The responses reflect current approaches laboratorians are taking to enhance the value of laboratory medicine. It is important to note that these results generally reflect quality improvement activities and demonstrate the transformation from a lab-centric to a collaborative patient-centric paradigm. And, in fact, if the traditional "Operational and Process Improvement" and "Quality Assurance Systems" sections are disregarded, seventy-four percent (74%) of the remaining initiatives point to a focus on collaborations on April 27 2019 http://hwmaint.clsjournal.ascls.org/ Downloaded from between laboratorians and other health care professionals to jointly develop multi-disciplinary improvement opportunities. The results of the collaborative efforts demonstrate value not only from laboratory technology, but also importantly from laboratory professionals ( Figure 1).

Laboratory Measures on Patient Outcomes Impact
Measuring the value of laboratory medicine has long been an elusive goal. When asked for the measures on which laboratorians rely, 184 codable responses fell within six categories as summarized in Table 3. Specific responses within each category can be found in supplemental information online (Table S-2). It was difficult to fully assess the nature of the measures solely from survey responses.
Still, using a Donabedian framework 7 , it appears that they are largely structural and process-oriented measures, sometimes limited to a narrow portion of the total testing process, e.g. within laboratory turnaround times. This high concentration of structural and process measures limits the ability to prove causality on improved patient and system outcomes. The most outcome-oriented measures were associated with antimicrobial stewardship and blood transfusion management which probably represents the low-hanging fruit of the value discussion.

Program Wishes to Demonstrate the Value of Laboratory Medicine
An established brainstorming technique (wishing) was used to elicit creative, potential approaches to novel programs/initiatives/interventions that could strongly demonstrate the value of laboratory medicine. The question was intended to help identify opportunities for improving outcomes and may suggest a path forward in achieving relevant value-based goals. The responses are divided into seven categories as detailed in Table 4. Specific ideas provided are listed in the supplemental information online (Table S-3).
The following is a brief summary of the aggregated 'wish list' responses: • Laboratory testing should be accurate and have proven clinical utility and effectiveness in patient management. Testing should also be accompanied with appropriate safety nets for prevention of errors in the pre-analytical, analytical, and post-analytical phases of testing.
• Laboratory reports should be communicated to the ordering provider and patients as deemed necessary for effective and timely application in the care of the patient.
• Laboratory results should be easy to access, to read, to interpret, and document recommended follow-up. Coordination of care should be the outcome with real time access to laboratory professional clinical consultative support.
• Other safety nets as applied to monitoring and support systems, whether manual or electronic, should be collaboratively developed and implemented. This will allow clinicians, laboratorians, healthcare staff, and patients to easily make informed decisions about effective patient management.
• All the needed actions and safety support should be appropriately funded with clear expectations for use and accountabilities. The balance measure of "cost effectiveness" should be applied to all initiatives.
• Patients should be supported to allow easy engagement with the development of their care plans, including setting expectations for quality of life and the "cause and effect" of their actions.

Discussion
Over 7 billion laboratory tests are performed annually in the United States. 4  Approximately four million newborns are screened by tests for congenital and metabolic disorders annually. 8 For the 5,000 infants with severe disorders, more specific testing, and for some, life-long monitoring by laboratory tests will follow. Adults are accustomed to periodic screening tests such as cholesterol, fasting blood glucose, fecal occult blood, urinalysis, Papanicolaou (Pap)/ HPV testing, and prostate specific antigen (PSA) tests. Not only are test results incorporated into specific clinical guidelines, but a majority of adults expect and desire these as part of their routine physical examinations. 9 Yet, despite these well-established uses for laboratory medicine, the clinical laboratory's role is still generally seen as a cost center where expenses should be minimized and the understanding of value is limited to the need for accurate, timely, and low-cost results without regard to demonstrating improved patient outcomes. 10 Furthermore, discussions of value are often limited to the diagnostic role of a specific analyte independent of the actual or potential contribution of the laboratory professional. The survey attempted to identify strategies for changing the discussion, yet the results spotlighted the limited efforts that were being made. In fact, the results point to just a few interventions where multiple responders identified the same focus areas.
Where results were identified, they were often linked to activities that were both multi-disciplinary and collaborative, spotlighting the importance of laboratorians joining the broader care delivery team. The importance of developing standardized processes involving protocols and best practices for diagnosis and treatment of disease states was also a common theme.
For example, initiatives related to infection prevention and therapy, in addition to providing overarching antibiotic stewardship, allow laboratory leaders to dynamically partner with other stakeholders to research and implement new technologies that can lead to faster and more accurate diagnosis and treatment. Accelerating identification of microbes and the application of local antimicrobial susceptibility testing to certain drugs (antibiograms) led to targeted and more effective antimicrobial therapies. 11 Genetic testing in diagnosis, prognosis, and treatment was raised as an evolving area that will require collaborative teams to understand and apply this new knowledge for better patient care and outcomes. Personalized medicine should also help to engage the patients through recommended lifestyle changes.

Conclusions
Though medical laboratory testing is ubiquitous in practice, the ability to precisely quantify laboratory medicine's actual contribution to patient outcomes, both short term and long term, remains challenging and relies mostly on anecdotal reports. Yet it is critically important that we engage in promoting the laboratory's relevance and communicate the value that certainly exists. Increased investment in the laboratory and its personnel from healthcare leaders is crucial to ensure up-to-date equipment, the availability of sufficient qualified medical laboratory professionals, the opportunities to develop and implement new laboratory tests, and the pursuit of quality strategies and practices that maximize contributions from this critical field.
The value and benefits of quality laboratory services are ultimately received by the patient, yet there are other stakeholders dependent on the laboratory to maximize patient benefits. As reported elsewhere, there are five domains that best capture these stakeholders and their needs: 1) the needs of the patient's care team in order to provide quality care to the patient; 2) the needs of Efforts to increase the public awareness of the value of laboratory medicine and its impact on all aspects of medicine are encouraging. The evolving complexity of laboratory medicine and its impact on health care is substantial. Failure to articulate effectively the value that is known, and the value yet to be described, poses risks for healthcare in that investment decisions will not be optimized for the opportunities that exist. It is important that clinical laboratory professionals adapt and build on work such as this so that the discussion of the contribution of laboratory services and information is understandable and utilized.