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In the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world.
−Removed: The patients we serve annually comprise approximately one-third of the adult population of the United States, and over a three-year period, we serve approximately one-half of the adult population in the United States.
+Added: The patients we serve annually comprise approximately one-third of the adult population of the United States, and over a three-year period, we serve approximately one-half of the adult population of the United States.
We estimate that annually we serve approximately half of the physicians and half of the hospitals in the United States.
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We operate our business and achieve our goals according to a clear set of principles we call “The Quest Way,” which consists of the following:
−Removed: • Our Purpose is to work together to create a healthier world, one life at a time.
−Removed: • Our Strategy to grow is to provide solutions that serve the evolving needs of our customers, based on our high quality, innovative, convenient and affordable services.
+Added: • Our Purpose, or why we exist, is to work together to create a healthier world, one life at a time.
+Added: • Our Strategy, or how we grow, is to provide solutions that serve the evolving needs of our customers, based on our high quality, innovative, convenient and affordable services.
• Our Culture, or how we work, is powered by what we call the “5Cs”:
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We drive growth by:
−Removed: • collaborating with healthcare providers and partners to leverage our broad access;
• offering an industry-leading menu of testing and other services;
+Added: • collaborating with healthcare providers and partners to leverage our broad access;
• leveraging our data assets and services to improve population health and enable value-based care;
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Our growth strategy is focused on our primary customer channels – physicians, hospitals, patients and consumers – supported by Advanced Diagnostics™ (defined below), strategic acquisitions, and continuous quality improvement.
−Removed: We serve approximately half the physicians in the United States each year.
−Removed: We serve virtually all types of physicians from primary care physicians and internists to specialists, including rheumatologists, cardiologists, neurologists, and obstetricians/gynecologists.
+Added: We serve approximately half the physicia ns in the United States each year.
+Added: We serve virtually all types of physicians from primary care physicians and internists to s pecialists, including rheumatologists, cardiologists, neurologists, and obstetricians/gynecologists.
We also serve physicians associated with accountable care organizations (“ACOs”), and Federally Qualified Health Centers (“FQHCs”).
−Removed: Physicians determine which laboratory to recommend or use based on a variety of factors, but we believe that we provide the most attractive service offering in the industry, including the most comprehensive test menu, innovative test offerings, a positive customer experience, a staff including medical and scientific experts, high quality, leading access and distribution, and data-powered integrated information-technology solutions.
−Removed: We believe that the growing market challenges faced by hospitals, including continued consolidation, price transparency, cost and utilization pressure, evolving healthcare payment models, capital needs, changing technology and limited resources, provide us with an opportunity to partner with them more effectively as they consider their laboratory testing strategy and drive demand for our expertise and services.
+Added: Physicians determine which laboratory to recommend or use based on a variety of factors, but we believe that we provide the most attractive service offering in the industry, including the most comprehensive test menu, innovative test offerings, a positive customer experience, deep medical and scientific expertise, high quality, leading access and distribution, and data-powered integrated information-technology solutions.
+Added: We believe that the growing market challenges faced by hospitals, including continued consolidation, price transparency, cost and utilization pressure, evolving healthcare payment models, capital needs, changing technology and limited resources, provide us with an opportunity to partner with them as they consider more effective ways to implement their laboratory testing strategy and drive demand for our expertise and services.
We serve approximately half the hospitals in the United States each year in many ways, including:
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• Acquiring outreach lab operations from hospitals.
−Removed: Quest looks for opportunities to acquire assets of outreach lab operations from hospitals whose in-house labs have expanded from supporting in-patients to supporting out-patients and ambulatory patients who see physicians affiliated with the hospital.
+Added: Quest looks for opportunities to acquire assets of outreach lab operations from hospitals whose in-house labs have expanded from supporting in-patients to supporting out-patients and ambulatory patients who see physicians that may or may not be employed or otherwise affiliated with the hospitals.
We also have joint venture arrangements with leading hospitals and health systems.
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We have taken steps to be recognized as the consumer-friendly provider of choice of diagnostic information services.
−Removed: Patients increasingly expect their healthcare experiences to be consumer-centric, which includes being more transparent,
−Removed: accessible and convenient.
+Added: Patients increasingly expect their healthcare experiences to be consumer-centric, which includes being more transparent, accessible and convenient.
Most patients have a choice when selecting a diagnostic testing provider, and our goal is to provide leading services in conveniently located patient service centers that can provide a comprehensive suite of testing services.
−Removed: Many of our 2,000 patient service centers are located inside large retail stores or in convenient retail settings across the United States.
+Added: Many of our 2,400 patient service centers are located inside large retail stores or in convenient retail settings.
We continue to enhance our operations to improve the patient experience in these locations.
−Removed: For example, our "Schedule at Check In" capability encourages patients to make appointments, which allows us to better manage demand and productivity and has reduced average wait times in the patient service centers.
−Removed: We also now provide mobile phlebotomy services in many parts of the United States so patients who prefer an in-home blood draw may access services for a fee.
−Removed: We are also making investments to improve the consumer digital experience, from locating a patient service center to receiving results on our MyQuest ® patient healthcare portal.
−Removed: We are also building the patient payment process into the digital customer experience, which not only improves the patient experience, but also helps our patient concession rate and reduces demands on phlebotomists.
−Removed: In response to the growing consumer desire to be more directly involved in and have more control over their health outcomes, we provide our QuestHealth.com platform to allow health-minded consumers to purchase testing directly from us without first having to make a doctor’s appointment.
+Added: For example, our "Schedule at Check In" capability encourages patients to make appointments, and our self-serve kiosks provide wait-time estimates for walk-in and standby patients and offer many language options.
+Added: These improvements allow us to better manage demand and productivity and have reduced average wait times in the patient service centers.
+Added: We also provide mobile phlebotomy services in many parts of the United States so patients who prefer an in-home blood draw may access our services for a fee.
+Added: We work to improve our digital experience, from making it easier for patients and consumers to locate a patient service center and receive results on our MyQuest ® patient healthcare portal to enabling providers to access their patients’ test result reports.
+Added: We are also integrating the patient payment process into the digital customer experience, which improves the patient experience, provides greater pricing transparency, helps our patient concession rate and reduces demands on phlebotomists.
+Added: As people are increasingly seeking to be more directly involved in and have more control over their health outcomes, we are seeking to meet this need.
+Added: Our QuestHealth.com platform empowers health-minded consumers to purchase testing directly from us without first having to visit their doctor.
Consumers who want to evaluate their health or monitor certain chronic conditions, such as diabetes or hepatitis, as well as those seeking privacy can use these self-directed options to identify and more frequently monitor health issues than their health plan or other payer may be willing to reimburse.
−Removed: A third-party physician reviews test orders and is available to consult with the consumer via a teleconsult about their test results.
−Removed: Our QuestHealth TM offering reflects our belief that by building on the foundation of our strong consumer focus we can capture growing opportunities in consumer-initiated testing and demand for expanded access to basic healthcare services.
+Added: We are enabling a third-party physician to review and place test orders and be available to consult with the consumer via a teleconsult about their test results.
+Added: We also launched health coaching on our QuestHealth.com platform.
+Added: Our QuestHealth™ offering reflects our belief that by building on the foundation of our strong consumer focus we can capture the growing opportunities presented by the growth of consumer-initiated testing and demand for expanded access to basic healthcare services.
+Added: In 2024, we launched a new service that offers patients experiencing symptoms of several common genital tract infections the option to self-collect a swab specimen, aimed at increasing privacy, convenience and speed of testing.
We also provide opportunities for companies with telehealth and retail business models to rebrand our testing and utilize our patient service centers to provide access.
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Advanced Diagnostics™ includes certain procedures in the areas of molecular diagnostics (including next-generation sequencing), oncology, neurology, companion diagnostics and non-invasive pre-natal and other germline genetic testing.
−Removed: We are a leading provider of Advanced Diagnostics™.
−Removed: Our investments in our Advanced Diagnostics™ offerings enhance our innovation capabilities and strengthen our service offering, making our Advanced Diagnostics™ offerings more attractive and accessible to physicians and hospitals.
−Removed: We are also seeking to apply the capabilities gained by these efforts to support other areas where we can make a meaningful difference in healthcare, including offerings to pharmaceutical companies and consumers.
−Removed: We provide an array of Advanced Diagnostics™ offerings across the spectrum, including in high growth areas such as Molecular Genomics and Oncology.
+Added: We are a leading provider of Advanced Diagnostics™ and provide an array of offerings across the spectrum, including in high growth areas such as Molecular Genomics and Oncology.
We have a portfolio of oncology tests that includes traditional oncology screening and anatomic pathology, such as cervical cancer and skin cancer screening and diagnosis.
−Removed: We are also well positioned to take advantage of advances in next generation sequencing to grow our business in cancer and other disease state testing.
+Added: are also well positioned to take advantage of advances in next generation sequencing to grow our business in cancer and other disease state testing.
This includes inherited genetics, newborn screening, and rare disease diagnosis, and solid tumor sequencing, such as to aid treatment selection and monitoring.
+Added: Our investments in our Advanced Diagnostics™ offerings enhance our innovation capabilities and strengthen our service offering, making our Advanced Diagnostics™ offerings more attractive and accessible to physicians and hospitals.
+Added: We are also seeking to apply the capabilities gained by these efforts to support other areas where we can make a meaningful difference in healthcare, including offerings to pharmaceutical companies and consumers.
We are also particularly focused on the rapidly growing areas of monitoring recurrence and therapy effectiveness.
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("Haystack Oncology") a cancer testing company that has developed a highly sensitive testing technology for detecting minimal-residual disease (“MRD”) by circulating tumor DNA due to residual or recurring cancer.
−Removed: Circulating tumor DNA (ctDNA) refers to tiny molecules of cancer shed by a solid tumor, such as colorectal or breast cancer, into the blood stream.
−Removed: We believe this acquisition positions us well to compete in the higher-growth clinical area of ctDNA solid-tumor MRD testing.
+Added: Circulating tumor DNA ("ctDNA") refers to DNA fragments shed by a solid tumor, such as colorectal or breast cancer, into the blood stream.
+Added: We believe this acquisition strengthens our comprehensive oncology portfolio by positioning us well to compete in the higher-growth clinical area of ctDNA solid-tumor MRD testing.
+Added: Since the acquisition, several organizations have used the Haystack Oncology MRD test in research, including for clinical trials.
+Added: During 2024, we also developed the test as a clinical offering in anticipation of making it available to oncologists.
In 2023, we also launched our QUEST AD-DETECT® test portfolio for assessing Alzheimer's disease risk using blood specimens, as opposed to testing by more costly or invasive methods, such as testing of cerebral spinal fluid by lumbar puncture.
+Added: We continue to add new testing to this suite of services for assessing the risk of Alzheimer's Disease, including isoform and plasma testing for patients with cognitive impairment.
+Added: In addition, our Autoimmune ANAlyzeR™ service helps primary care physicians comprehensively screen for autoimmune disorders to accelerate diagnosis and care by specialists.
Acquisitions and Capital Deployment
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We will continue to invest in our business in a disciplined manner, including focusing on enhancing our solid foundation of strategic assets and capabilities.
−Removed: In 2023, we acquired Haystack Oncology, as well as certain assets of the laboratory services business of NewYork-Presbyterian, one of the nation's largest and most comprehensive academic medical centers.
−Removed: We also completed our acquisition of select assets of Northern Light Laboratory, the outreach laboratory services business of Northern Light Health, a large integrated healthcare system in Maine.
+Added: During 2024, we completed acquisitions for an aggregate purchase price of $2.2 billion.
+Added: We acquired select assets of the outreach laboratory services business of Allina Health, which serves providers and patients in Minnesota and Wisconsin, as well as select assets of the outreach laboratory services business of OhioHealth and the outreach laboratory services business of University Hospitals, which each serve providers and patients in Ohio.
+Added: In August 2024, we also acquired all of the issued and outstanding common shares of LifeLabs Inc.
+Added: and all of the partnership interests of BPC Lab Finance LP (collectively, "LifeLabs"), which provides laboratory diagnostic information and digital health connectivity systems in Canada.
+Added: During the full year of 2024, LifeLabs performed approximately 140 million laboratory tests to help diagnose, treat, monitor and prevent diseases for millions of Canadians.
+Added: LifeLabs operates approximately 15 laboratories, over 350 collection centers in British Columbia, Ontario and Saskatchewan, and an extensive network of couriers and mobile phlebotomists.
+Added: LifeLabs also partners with governments and companies to develop technologies and customized services.
Our significant acquisitions in each of the last three years are further discussed in Note 6 to the audited consolidated financial statements (Part II, Item 8 of this Report).
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We expect to return a majority of our free cash flow to stockholders through a combination of dividends and share repurchases.
−Removed: Consistent with that expectation, in February 2024, we announced that we increased our quarterly common stock cash dividend by approximately 5.6%, from $0.71 per common share to $0.75 per common share.
+Added: Consistent with that expectation, in January 2025, we announced that we increased our quarterly common stock cash dividend by approximately 6.7%, from $0.75 per common share to $0.80 per common share.
This represents our 14 th increase in the dividend since the beginning of 2012.
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The Quality Program is designed so that the quality of laboratory services is monitored objectively and evaluated systematically to deliver superior quality care, identify opportunities to improve patient care and resolve identified problems.
−Removed: To help achieve our goal of becoming recognized as the undisputed quality leader in the diagnostics information services industry, we have implemented our Quality System Framework, which serves as a reference guide for our employees and describes our Quality System Elements, which provide the structure for each laboratory to achieve and maintain quality processes.
+Added: To help achieve our goal of becoming recognized as the undisputed quality leader in the diagnostics information services industry, we have implemented our Quality System Framework, which serves as a reference guide for our employees and describes our Quality System Elements to provide the structure for each laboratory to achieve and maintain quality processes.
We also have a robust Supplier Quality Program designed to help us ensure we have a high-quality supplier network and to raise the bar of quality expectations across that network.
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We strive to enhance operational excellence and improve our efficiency across our value chain and operations, from the time that we first interact with a potential customer until the time we receive payment for our services.
−Removed: Improving our operations can yield many benefits, including improving our quality and competitiveness, strengthening our foundation for growth, and increasing employee engagement and shareholder value.
+Added: Improving our operations through standardization, optimization, digitization and automation can yield many benefits, including improving our quality and competitiveness, strengthening our foundation for growth, supporting our growth strategy, and increasing employee engagement, customer service and shareholder value.
We are guided by a service dashboard that focuses throughout our operations on quality for consumers, healthcare providers and employees, including medical quality, on-time delivery, competitive costs and employee safety.
Our cost excellence program, Invigorate, includes structured plans to drive savings and improve productivity across the value chain, including in such areas as patient services, logistics and laboratory operations, revenue services, information technology ("IT") and procurement.
−Removed: Our Invigorate program has consistently delivered 3% of annual cost savings and productivity improvements, year in and year out to partly offset pressures from the current inflationary environment, including labor and benefit cost increases, and reimbursement pressures.
−Removed: We are leveraging automation and AI to improve productivity, and also improve quality across our entire value chain, not just in the laboratory.
+Added: Our Invigorate program has consistently delivered 3% of annual cost savings and productivity improvements, which partly offset pressures from the current inflationary environment, including labor and benefit cost increases, and reimbursement pressures.
+Added: We are leveraging automation and AI to improve productivity and improve quality across our entire value chain, not just in the laboratory.
+Added: For example, in 2024, we advanced our use of automation in front-end specimen processing to include five of our labs, freeing more of our processors to focus on higher-order work.
Other areas of focus include reducing denials and patient concessions, enhancing the digital experience, and selecting and retaining talent.
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The value creation side of our business includes product and commercial marketing and is organized by clinical franchise and focuses on customer solutions for the marketplace, including new test development and diagnostic insights.
−Removed: Our clinical franchises – Cardiometabolic, Endocrine, and Wellness (CMEW), Drug Monitoring and Toxicology, Infectious Diseases and Immunology, Molecular Genomics and Oncology, Neurology, and Women’s and Reproductive Health – enable us to perform like a boutique laboratory while maintaining our scale advantages, and work with our research and development and commercial organizations to identify and deliver new and improved solutions.
+Added: Our clinical franchises – Cardiometabolic, Endocrine, and Wellness, Drug Monitoring and Toxicology, Infectious Diseases and Immunology, Molecular Genomics and Oncology, Neurology, and Women’s and Reproductive Health – enable us to operate like a boutique laboratory while maintaining our scale advantages, and work with our research and development and commercial organizations to identify and deliver new and improved solutions.
The value delivery side includes sales, laboratory operations, field operations, logistics and client services.
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Assets and Capabilities
−Removed: Connectivity ● Provide healthcare connectivity solutions to >518,000 clinician and hospital accounts and interface with >920 electronic health records systems
−Removed: Data ● One of the largest private databases of de-identifiable laboratory test results:
+Added: Connectivity ● Provide healthcare connectivity solutions to approximately 650,000 clinician and hospital accounts and interface with over 1,000 electronic health records systems
+Added: Data ● One of the world's largest databases of de-identifiable laboratory test results:
>80 billion patient data points
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Other Healthcare Professionals ● Approximately 25,000 phlebotomists, paramedics, nurses and other health and wellness professionals
−Removed: Consumer Access ● Approximately 7,400 patient access points, including phlebotomists in physician offices, the most extensive patient service center network in the United States with approximately 2,000 locations, and mobile phlebotomy services
−Removed: Health Plan Participation ● Access to approximately 90% of U.S.
+Added: Consumer Access ● Approximately 8,000 patient access points, including phlebotomists in physician offices, and an extensive patient service center network with approximately 2,400 locations, and mobile phlebotomy services
+Added: Health Plan Participation ● Access to over 90% of U.S.
insured lives
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Range of Testing ● Industry-leading test menu across clinical and pathology sub-specialty areas and diagnostic technologies
−Removed: Patents ● Own or control approximately 1,200 issued and over 400 pending patents worldwide in 2023
+Added: Patents ● Own or control approximately 1,200 issued and nearly 400 pending patents worldwide in 2024
Strong Relationships with Health Plans and Other Payers
−Removed: Most of the services we perform are paid for by commercial payers, including large national health plans, regional and local health plans and government payers, which includes Medicare and Medicaid.
−Removed: Through these payers, we estimate that we have access to approximately 90% of insured lives in the United States.
+Added: Most of the services we perform are paid for by third-party payers, including large national health plans, regional and local health plans and government payers, which includes Medicare and Medicaid.
+Added: Through these payers, we estimate that we have access to over 90% of insured lives in the United States.
We work with payers to reduce the cost of care, improve the customer experience and drive better outcomes for patients.
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We also offer extended care services to help close gaps in care designed to be attractive to payers.
−Removed: We are a leading provider of innovation in diagnostic information services that help healthcare market participants care for their patients through better testing for predisposition, screening, monitoring, diagnosis, prognosis and treatment choices, and that can deliver high clinical value to the medical community and reduce the overall cost of healthcare.
−Removed: We develop and introduce new tests through our research and development operations.
−Removed: Our capabilities include discovery, technology development and clinical validation of diagnostic tests.
−Removed: We also partner with other developers of new technologies, services and tests to transfer their innovations to the marketplace, using our in-house expertise ( e.g.
−Removed: , strength in new service development and commercialization of testing services).
−Removed: These developers include large commercial manufacturers, the academic community, pharmaceutical and biotechnology firms, emerging medical technology companies, other laboratory companies and others that develop and commercialize novel diagnostics, pharmaceutical and device technologies.
−Removed: Given our expertise and broad U.S.
−Removed: network, we believe we are the distribution channel of choice for developers of new diagnostic information solutions.
−Removed: Our innovation strategy focuses on new services and solutions for unmet clinical needs that will improve patient care and outcomes as well as economic value for patients, health plans and other payers.
−Removed: We believe our research and development team includes several leaders in a number of fields, including in genomics, genetics and bioinformatics, as well as in disease states, such as oncology, neurology, cardiometabolic disease and other disorders.
−Removed: We also maintain relationships with advisers and consultants who are leaders in key fields of science and medicine who advise us with our internal team of experts, complementing our expertise.
−Removed: We endeavor to improve test processes, including through increased automation.
−Removed: In addition, we aim to develop holistic solutions responsive to challenges that healthcare providers and patients face, by developing solutions of tests, information and services focused on specific clinical challenges.
−Removed: We look to offer solutions from our large dataset and data analytics capabilities to help providers and health plans identify opportunities to optimize appropriate laboratory utilization, align clinical practice to medical guidelines, and inform patient-care decisions.
−Removed: We also look for innovations and solutions that are more convenient, less invasive and more cost effective than currently available options.
−Removed: We seek innovation in the ways we bring solutions to customers, and in the customer experience, including enhanced services and end-to-end solutions for convenience and support.
Medical and Scientific Expertise
−Removed: We have strong medical and scientific expertise and aspire to be a trusted authority in diagnostic medicine, provide insights and tools to support public and personal health, lead and facilitate scientific discussion and inspire innovation.
+Added: We leverage our medical and scientific expertise and aspire to be a trusted authority in diagnostic medicine, provide insights and tools to support public and personal health, lead and facilitate scientific discussion and inspire innovation.
Our medical and scientific experts regularly provide presentations, symposia and webinars regarding diagnostic testing and participate on scientific committees determining guidelines for diagnostic usage.
They also publish research that demonstrates the clinical value and importance of diagnostic testing, including in connection with our research and development efforts, in peer-reviewed journals, textbooks and other publications.
−Removed: For over 30 years, the Company has published the Quest
−Removed: Diagnostics ® Drug Testing Index, TM a series of reports on national workplace drug positivity trends based on the Company's employer workplace drug testing data, that is widely cited by employers, the federal government and the media to help identify and quantify drug abuse among the nation's workforce.
+Added: For over 30 years, the Company has published the Quest Diagnostics ® Drug Testing Index, TM a series of reports on national workplace drug positivity trends based on the Company's employer workplace drug testing data, that is widely cited by employers, the federal government and the media to help identify and quantify drug abuse among the nation's workforce.
The Company also publishes Quest Diagnostics ® Health Trends, ® a series of scientific reports that provide insights into health topics, based on analysis of objective clinical laboratory data, to empower better patient care, population health management and public health policy.
−Removed: In 2023, we published Health Trends ® reports on lipid- associated risk of cardiovascular disease and, with the Centers for Disease Controls and Prevention (“CDC”), on hepatitis C infections in the United States.
−Removed: Our annual Health Trends report on clinical drug testing revealed potentially dangerous mixing of the opioid fentanyl and the horse tranquilizer xylazine in clinically drug tested patients.
+Added: In 2024, we published a Health Trends ® report with the University of Alabama that suggests adherence to guideline-based laboratory testing and treatment of pregnant women for two of the most prevalent sexually transmitted infections is suboptimal in the United States, with potentially dire effects on maternal and newborn health.
We are a founding member, with other leading diagnostic laboratories outside the United States, of the Global Diagnostics Network TM , a strategic working group of diagnostic laboratories committed to unleashing and sharing local innovation to increase global access to diagnostic science, information and services and generating enhanced diagnostic insights to improve the delivery of global healthcare.
−Removed: With researchers from Johns Hopkins University and the other laboratories participating in the Global Diagnostics Network, we produced the largest analysis of cholesterol lipid levels, based on nearly half a billion de-identified, aggregated test results, to illuminate trends in cardiovascular disease in the United States and sixteen other countries.
Health Information Technology Solutions and Information Assets
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Individuals can also use their smartphone or computer to order a consumer-initiated test from us at QuestHealth.com.
−Removed: Our connectivity platform enables providers to order tests and receive results from us easily from up to 920 electronic health records.
+Added: Our connectivity platform enables providers to easily order tests and receive results from us from more than 1,000 electronic health records systems.
We are expanding our use of digital and other technology tools to improve our customer experience for patients and providers.
−Removed: We also have significant information assets and offer a robust portfolio of powerful analytics that inspire action and deliver value to an array of customers.
+Added: We also have significant information assets and offer a robust portfolio of powerful analytics that inspire action and deliver value to our customers.
We offer an array of solutions based on data insights, including retrospective analytics solutions for physicians, hospitals, health plans, pharmaceutical companies and public health organizations.
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We believe that the breadth and depth of our data, combined with our powerful analytics capabilities, enables us to take advantage of important data-based opportunities in diagnostics, and provides us a competitive advantage.
+Added: We are a leading provider of innovation in diagnostic information services that help healthcare market participants care for their patients through better testing for predisposition, screening, monitoring, diagnosis, prognosis and treatment choices, and that can deliver high clinical value to the medical community and reduce the overall cost of healthcare.
+Added: We develop and introduce new tests through our research and development operations.
+Added: Our capabilities include discovery, technology development and clinical validation of diagnostic tests.
+Added: We also partner with other developers of new technologies, services and tests to transfer their innovations to the marketplace, using our in-house expertise (e.g., strength in new service development and commercialization of testing services).
+Added: These developers include large commercial manufacturers, the academic community, pharmaceutical and biotechnology firms, emerging medical technology companies, other laboratory companies and others that develop and commercialize novel diagnostics, pharmaceutical and device technologies.
+Added: Given our expertise and broad U.S.
+Added: network, we believe we are the distribution channel of choice for developers of new diagnostic information solutions.
+Added: Our innovation strategy focuses on new services and solutions for unmet clinical needs that will improve patient care and outcomes as well as economic value for patients, health plans and other payers.
+Added: Our research and development team includes leaders in a number of fields, including in genomics, genetics and bioinformatics, as well as in disease states, such as oncology, neurology, cardiometabolic disease and other disorders.
+Added: We also maintain relationships with advisers and consultants who are leaders in key fields of science and medicine who advise us with our internal team of experts, complementing our expertise.
+Added: We endeavor to improve test processes, including through increased automation.
+Added: In addition, we aim to develop holistic solutions responsive to challenges that healthcare providers and patients face, by developing solutions of tests, information and services focused on specific clinical challenges.
+Added: We look to offer solutions from our large dataset and data analytics capabilities to help providers and health plans identify opportunities to optimize appropriate laboratory utilization, align clinical practice to medical guidelines, and inform patient-care decisions.
+Added: We also look for innovations and solutions that are more convenient, less invasive and more cost effective than currently available options.
+Added: We seek innovation in the ways we bring solutions to customers, and in the customer experience, including enhanced services and end-to-end solutions for convenience and support.
Artificial Intelligence
−Removed: We have a long history of using advanced technologies to automate processes, improve customer service, generate insights from lab and other data, and stimulate innovation.
−Removed: We believe AI can help improve the quality of our screening and diagnostic capabilities.
−Removed: For instance, we now use AI to help identify patterns in patient specimens evaluated for infectious microbes and chromosomal anomalies that may signify disease and are evaluating its potential to aid in evaluating specimens for signs of cancer.
−Removed: We also believe that AI can help improve our operating efficiency.
−Removed: In 2023, we created an initiative to deploy generative AI to improve several areas of our business, including software engineering, customer service, claims analysis, scheduling optimization, specimen processing and marketing.
−Removed: We expect to further develop these projects in 2024.
+Added: We have a long history of using advanced technologies to automate processes, improve customer service, generate insights from lab and other data, improve the customer experience, and stimulate innovation.
+Added: We use AI to help drive innovation and operational efficiency at Quest Diagnostics.
+Added: AI helps improve the quality of our screening and diagnostic capabilities.
+Added: For instance, in 2024, we extended our AI capabilities in microbiology to include the ability to segregate out specimens with no evidence of microbial growth so our medical scientists can concentrate on reviewing those with the greatest likelihood of disease.
+Added: AI also helps improve our operating efficiency.
+Added: We continue to broaden our use of AI in customer service to help our representatives access answers more quickly, improving their effectiveness and service quality.
We are committed to using AI in an ethical, responsible and compliant way.
−Removed: We have implemented a formal AI Governance oversight committee and established multiple AI safeguards to minimize risks associated with AI, including, but not limited to, expanded security and privacy measures, increased user access controls, end user training and attestation, and standard operating procedures.
−Removed: We seek to align our practices with the NIST AI Risk Management Framework (AI RMF) and strategically partner with external AI experts as needed to ensure we remain informed about the latest technological advancements in the industry.
−Removed: Over time, we believe generative AI will help us innovate and grow in a responsible manner
−Removed: while also enhancing customer and employee experiences and bring cost efficiencies.
−Removed: We intend to continue to be at the forefront of the innovative, responsible and secure use of AI, including generative AI, in diagnostic information solutions.
+Added: We have implemented a formal AI governance oversight committee and established multiple AI safeguards to minimize risks associated with AI, including, but not limited to, expanded security and privacy measures, increased user access controls, employee and other end user training and certification, and standard operating procedures.
+Added: Our AI program has been designed to comply with applicable laws, regulations and AI frameworks, and we strategically partner with external AI experts as needed to ensure we remain informed about the latest technological advancements in the industry.
+Added: Over time, we believe generative AI will help us innovate and grow in a responsible manner while also enhancing customer and employee experiences and bring cost efficiencies.
+Added: We intend to be at the forefront of the innovative, responsible and secure use of AI, including generative AI, in diagnostic information solutions.
A Commitment to Helping the Underserved
−Removed: As part of our commitment to create a healthier world, we, along with our Quest Diagnostics Foundation, launched our Quest for Health Equity ® initiative, which aims to reduce health disparities in underserved communities in the United States through a combination of testing services, education programs, alliances and financial support.
−Removed: Since its inception, we have committed approximately $38 million to more than 70 programs launched across the United States and Puerto Rico, including supporting community workforce development, COVID-19 testing and vaccination events, wellness events, educating young students on healthy nutrition choices and expanding research and mentorship opportunities for Black and Hispanic scholars.
−Removed: Numerous Quest for Health Equity ® undertakings demonstrate our commitment to FQHCs and the people they serve, including by providing free lab testing services.
−Removed: We are also looking at ways we can assist in addressing social determinants of health that can create barriers to healthcare for marginalized communities and other inequities in the healthcare system.
+Added: As part of our commitment to create a healthier world, we, along with our Quest Diagnostics Foundation, launched an initiative to reduce health disparities in underserved communities in the United States through a combination of testing services, education programs, alliances and financial support.
+Added: Since its inception, we have committed approximately $46 million to more than 80 programs launched across the United States and Puerto Rico, including supporting community workforce development, COVID-19 testing and vaccination events, wellness events, educating young students on healthy nutrition choices and expanding research and mentorship opportunities.
+Added: Numerous undertakings demonstrate our commitment to FQHCs and the people they serve, including by providing free lab testing services.
+Added: We are also looking at ways we can assist in addressing social determinants of health that can create barriers to healthcare for marginalized communities in the healthcare system.
BUSINESS OPERATIONS
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We see opportunities to bring our experience and expertise in diagnostic information services to markets outside the United States, including leveraging existing facilities to serve new markets.
+Added: In August 2024, we acquired LifeLabs, which provides laboratory diagnostic information and digital health connectivity systems in Canada.
Diagnostic Information Services
7 unchanged sentences
Commonly ordered routine tests include blood chemistries, urinalysis, allergy tests and complete blood cell counts.
−Removed: Non-routine tests may require professional “hands-on” attention from highly-skilled technical personnel, generally require more sophisticated data
−Removed: analysis, technology, equipment or materials, may be performed less frequently than routine tests and may be reimbursed at higher levels than routine tests.
+Added: Non-routine tests may require professional “hands-on” attention from highly-skilled technical personnel, generally require more sophisticated data analysis, technology, equipment or materials, may be performed less frequently than routine tests and may be reimbursed at higher levels than routine tests.
It may not be practical, from a cost-effectiveness or infrastructure perspective, for many hospitals, ACOs, commercial laboratories or physician office laboratories to develop and perform a broad menu of non-routine tests or to perform low-volume non-routine testing in-house.
−Removed: Such tests generally are outsourced to a clinical testing laboratory which can perform these non-routine tests.
−Removed: Some non-routine tests are Advanced Diagnostics.
−Removed: Advanced Diagnostics™ includes certain procedures in the areas of molecular diagnostics (including next-generation sequencing), oncology, neurology, companion diagnostics and non-invasive pre-natal and other germline genetic testing.
+Added: Such tests generally are outsourced to a clinical testing laboratory that can perform these non-routine tests.
+Added: Some non-routine tests are Advanced Diagnostics™, which includes certain procedures in the areas of molecular diagnostics (including next-generation sequencing), oncology, neurology, companion diagnostics and non-invasive pre-natal and other germline genetic testing.
Anatomic pathology involves the diagnosis of cancer and other diseases and medical conditions through examination of tissue and cell samples taken from patients.
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We believe that offering services, solutions and insights based on a full range of tests, information assets and other capabilities strengthens our market offering, market position and reputation.
−Removed: We offer broad access to clinical testing through a nationwide network of laboratories, including advanced laboratories as well as rapid response laboratories (smaller facilities where we can quickly perform an abbreviated menu of routine tests for customers that require rapid turnaround times).
+Added: We offer broad access to clinical testing through a network of laboratories, including advanced laboratories as well as rapid response laboratories (smaller facilities where we can quickly perform an abbreviated menu of routine tests for customers that require rapid turnaround times).
We operate 24 hours a day, 365 days a year.
−Removed: Our nationwide network also includes patient service centers, phlebotomists in physician offices, and our connectivity resources, including call centers and mobile phlebotomists, nurses and other health and wellness professionals.
+Added: Our network also includes patient service centers, phlebotomists in physician offices, and our connectivity resources, including call centers and mobile phlebotomists, nurses and other health and wellness professionals.
Our large in-house staff of medical and scientific experts, including medical directors, scientific directors, genetic counselors and board-certified geneticists, provide medical and scientific consultation to healthcare providers and patients regarding our tests and test results, and help them best utilize our services to improve outcomes and enhance satisfaction.
We also provide testing (including anatomic pathology) services and medical director services at hospital laboratories.
−Removed: We are a leading provider of diagnostic information services for infectious disease, such as tuberculosis ( e.g.
−Removed: , our T.SPOT.
−Removed: TB and Quantiferon offerings) and tick-borne disease ( e.g.
−Removed: , our Accutix™ offering).
−Removed: We strive to be the first to provide diagnostic solutions for emerging infectious diseases ( e.g ., our offerings for mpox virus).
−Removed: We have comprehensive offerings in drug monitoring and toxicology, in neurology diagnostics, in advanced cardiovascular diagnostic information services ( e.g ., our CARDIO IQ ® and Cleveland HeartLab™ offerings through our Cardiometabolic Center of Excellence TM ), and in cancer diagnostics .
+Added: We are a leading provider of diagnostic information services, developing and delivering comprehensive offerings to help physicians manage patients across disease stages, from screening for early risk to treatment selection and monitoring to post-treatment evaluation.
+Added: We have comprehensive test offerings in cardiometabolic and endocrine;
+Added: clinical drug monitoring and toxicology;
+Added: infectious disease, including autoimmune;
+Added: neurology diagnostics, including Alzheimer’s disease;
+Added: and women’s health, including prenatal genetics.
+Added: We strive to provide diagnostic solutions for emerging infectious diseases, and were the first commercial laboratory to introduce a test for the H5 avian flu virus based on a preparedness contract from the Centers for Disease Controls and Prevention (“CDC”).
We also provide workplace drug testing services, testing urine, hair, and oral fluid specimens, and are certified by the U.S.
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These services are sold directly to employers, through resellers and health plan partners.
−Removed: We offer health IT solutions, including our products and national healthcare provider network, to help healthcare organizations and clinicians empower better health by leveraging the power of our significant information assets, including many years of test result data, and our technology prowess, including our history of providing leading IT for diagnostic information services.
+Added: We offer health IT solutions, including our products and national healthcare provider network, to help healthcare organizations and clinicians empower better health by leveraging the power of our significant information assets, including one of the world's largest databases of de-identifiable clinical lab results, and our technology prowess, including our history of providing leading IT for diagnostic information services.
Our portfolio of offerings is designed to address analytic, clinical and financial needs.
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Once gaps are identified, we engage patients in our retail sites, in home or by telephone, including through our call centers and our mobile capabilities, including highly trained healthcare professionals.
−Removed: In 2022, we enhanced our extended care offering by acquiring Pack Health, LLC ("Pack Health") which offers patient engagement services that help individuals adopt healthier behaviors to improve outcomes.
−Removed: We offer services to pharmaceutical companies, including clinical trials testing, and have expertise in developing laboratory tests for U.S.
−Removed: Food and Drug Administration (“FDA”) submission as companion diagnostics and laboratory developed tests (“LDTs”) for complementary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
−Removed: We also offer Quest Clinical Trials Connect™ to help accelerate clinical trials (and thus the speed of drugs to market) through better patient recruitment, involvement and management, and improved physician outreach.
−Removed: We also offer Pack Health's patient engagement services to our pharma clients.
+Added: We offer services to pharmaceutical companies, including clinical trials laboratory testing, population analytics and patient engagement services.
+Added: We also develop laboratory tests for U.S.
+Added: Food and Drug Administration (“FDA”) submissions as companion diagnostics and laboratory developed tests (“LDTs”) for complementary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
+Added: In addition, we offer Quest Clinical Trials Connect™ to help accelerate clinical trials (and thus the speed of drugs to market) through better patient recruitment, involvement and management, and improved physician outreach.
Diagnostic Solutions
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Unfortunately, as a result of a flawed implementation of PAMA, the data collected did not accurately represent the laboratory market as required under PAMA.
−Removed: Independent laboratories were overrepresented, and hospitals and physician office laboratories were underrepresented, making the first round of PAMA cuts too extreme and resulting in below market rates.
+Added: Independent laboratories were overrepresented, and hospitals and physician office laboratories were underrepresented, making the first round of PAMA cuts too extreme.
+Added: The three years of cuts exceeded the original 10-year savings projections.
PAMA calls for further revision of the Medicare Clinical Laboratory Fee Schedule (“CLFS”) for years after 2020, based on future surveys of market rates.
−Removed: PAMA's next data collection and reporting period have been delayed, most recently by federal legislation adopted in November 2023 (the Further Continuing Appropriations and Other Extensions Act of 2024), which further delayed the reimbursement rate reductions and reporting requirements until January 1, 2025;
+Added: Congress has delayed cuts five times (2021 - 2025) and delayed 2019 data reporting six times (2020 - 2025).
Reimbursement rate reduction from 2026-28 is capped by PAMA at 15% annually.
−Removed: Congress reintroduced federal legislation in 2023 (the Saving Access to Laboratory Services Act), which, if enacted, would reform PAMA and create a true market-based CLFS.
+Added: Congress reintroduced federal legislation in 2023 (the Saving Access to Laboratory Services Act), which would reform PAMA and create a true market-based CLFS.
Health plans driving value in lab spending Some hospitals provide outreach testing and may encourage clinicians to send their outreach testing volume to the hospital's laboratory.
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We are finding increased interest among health plans in driving better value in spending for laboratory testing.
−Removed: Health plans increasingly are taking steps to encourage the movement of testing volume to high value, lower cost providers like our Company, including by identifying preferred provider partners, plan design changes (e.g., zero-dollar out-of-pocket costs for members using preferred providers) and better aligning reimbursement rates for hospital-based providers and independent commercial laboratories.
+Added: Health plans increasingly are taking steps to encourage the movement of testing volume to high value, lower cost providers like our Company, including by identifying preferred provider partners, plan design changes ( e.g.
+Added: , zero-dollar out-of-pocket costs for members using preferred providers) and better aligning reimbursement rates for hospital-based providers and independent commercial laboratories.
The UnitedHealthcare Preferred Lab Network, which chose us to participate, is an example of a health plan taking these steps.
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As a result, they are becoming more sophisticated in their understanding of their healthcare needs and their expectations of healthcare providers.
−Removed: In addition, consumers often are bearing increased financial responsibility for their healthcare (e.g., high deductible health plans;
+Added: In addition, consumers often are bearing increased financial responsibility for their healthcare ( e.g.
+Added: , high deductible health plans;
rising deductibles).
−Removed: In our experience, consumers are more focused on transparency, ease of doing business and understanding diagnostics information services than they have been in the past.
+Added: In our experience, consumers are more focused on transparency, ease of doing business and better understanding diagnostics information services than they have been in the past.
Consumers increasingly are demanding convenience and a superior and personalized experience relevant to their needs.
−Removed: During the COVID-19 pandemic, we saw consumers increase their use of telemedicine capabilities, increase their responsibility for their own healthcare (e.g., increased consumer-initiated testing;
−Removed: increased specimen self-collection) and increase their openness to new delivery channels (e.g., retail;
+Added: During the COVID-19 pandemic, we saw consumers increase their use of telemedicine capabilities, increase their responsibility for their own healthcare ( e.g.
+Added: , increased consumer-initiated testing;
+Added: increased specimen self-collection) and increase their openness to new delivery channels ( e.g.
convenient "pop-up" test centers).
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Increasingly, consumers are motivated to find high quality service providers with strong digital experience delivery engines, accessible customer service and lower prices, like our Company.
−Removed: Our consumer-initiated testing offering is part of our response to this trend.
+Added: Our physician-ordered consumer-initiated testing offering is part of our response to this trend.
Prevention and wellness We believe that the value of detection, prevention, wellness and personalized care is well recognized.
Government agencies and other customers discussed herein increasingly focus on helping the healthy stay healthy, detecting symptoms among those at risk and providing preventative insight and care that helps avoid or reduce the negative impacts of a disease.
−Removed: Medical innovation Medical developments are creating new opportunities and new challenges and disrupting the healthcare environment.
−Removed: For example, digital pathology is an emerging technology that may change the practice of pathology.
−Removed: IT that includes self-learning or AI features is growing and impacting healthcare.
+Added: Medical innovation Medical developments are creating new opportunities and new challenges while disrupting the healthcare environment.
+Added: For example, digital pathology is a technology that we are currently deploying that may change the practice of pathology.
Continuing advances in genomics and proteomics are expected to give rise to new, more sophisticated and specialized diagnostic tests.
These advances also are spurring interest in and demand for precision medicine, which relies on diagnostic and prognostic testing and in which data information services and strategies are used to deliver the most effective healthcare to the right populations and individuals.
−Removed: For example, we expect to help expand patient access to diagnostic services advancing precision medicine for rheumatoid arthritis based on a novel test developed by Scipher Medicine, a precision immunology company.
We also look for innovations and solutions that are more convenient, less invasive and more cost effective than currently available options.
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In 2023, we acquired Haystack Oncology, a cancer testing company that has developed a highly sensitive testing technology for detecting MRD due to residual or recurring cancer.
−Removed: A collaboration with Rutgers University involving our Haystack MRD™ technology is expected to help evaluate therapeutic response and provide molecular insights for a clinical trial of certain patients treated for breast cancer.
−Removed: Through a collaboration with Sarepta Therapeutics, a leader in precision genetic medicine for rare diseases, we developed and were granted Breakthrough Device Designation from the FDA for a test to help identify patients eligible for treatment with a Sarepta-created gene therapy for certain individuals with Duchenne muscular dystrophy.
+Added: We believe this acquisition strengthens our comprehensive oncology portfolio by positioning us well to compete in the higher-growth clinical area of ctDNA solid-tumor MRD testing.
+Added: We are collaborating with Universal DX and Mainz Biomed Partners, two biotech companies focused on colorectal cancer.
+Added: The collaborations aim to combine innovative liquid biopsy screening technologies with our expertise and scale.
Demand also is growing toward comprehensive care management solutions that serve patients, payers and healthcare providers by improving clinical decision support and access to patient data, and by increasing patient participation in care management and population health management.
−Removed: Innovation also includes making healthcare services, including laboratory testing services, more convenient for populations and consumers to access, including at home (e.g., telehealth) or in retail settings.
+Added: Innovation also includes making healthcare services, including laboratory testing services, more convenient for populations and consumers to access, including at home ( e.g.
+Added: , telehealth) or in retail settings.
Healthcare industry evolution;
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Physicians frequently now are employed by hospitals, ACOs or large group practices integrated with hospitals, instead of organizing physician-owned practices, which is impacting the dynamics for whether clinical testing is performed in or outside of a hospital.
−Removed: Physicians and other clinicians also increasingly are being employed by health plans, large retailers, other non-traditional industry entrants (e.g., private equity firms) or their affiliates.
+Added: Physicians and other clinicians also increasingly are being employed by health plans, large retailers, other non-traditional industry entrants ( e.g.
+Added: , private equity firms) or their affiliates.
Value-based reimbursement and demand for convenience and greater availability are contributing to changes in the healthcare system.
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Centers for Medicare and Medicaid Services (“CMS”) has refreshed its strategy to address the national push toward value-based care for Medicare and Medicaid beneficiaries, and set goals for value-based reimbursement to be achieved.
−Removed: CMS has stated that the Medicare Sharing Savings Program for ACOs is a critical component of CMS' vision to advance health equity, drive high-quality, person-centered care and promote affordability and sustainability of the Medicare program.
+Added: CMS has stated that the Medicare Sharing Savings Program for ACOs is a critical component of CMS' vision to drive high-quality, person-centered care and promote affordability and sustainability of the Medicare program.
CMS has stated that its goal is for all people in traditional Medicare to be in an ACO by 2030, and is adopting policies to drive growth in ACO participation.
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Hospitals are under significant pressure, and hospitals and large retailers are evolving.
−Removed: Healthcare services increasingly are being provided by non-traditional providers (e.g., physician assistants), in non-traditional venues (e.g., retail medical clinics, urgent care centers) and using new technologies (e.g., telemedicine, digital pathology).
+Added: Healthcare services increasingly are being provided by non-traditional providers ( e.g.
+Added: , physician assistants), in non-traditional venues ( e.g.
+Added: , retail medical clinics, urgent care centers) and using new technologies ( e.g., telemedicine, digital pathology).
Pricing transparency There has been a trend toward greater pricing transparency in healthcare, including in the laboratory testing marketplace.
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Competition The diagnostic information services industry remains fragmented, highly competitive and subject to new competitors.
−Removed: Competition is emerging from new technologies (e.g., digital pathology) and growing from non-traditional competitors (e.g., a government agency or an employer establishing its own clinical laboratory for testing;
+Added: Competition is emerging from new technologies ( e.g.
+Added: , digital pathology) and growing from non-traditional competitors ( e.g.
+Added: , a government agency or an employer establishing its own clinical laboratory for testing;
providers of consumer-initiated testing).
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However, in light of other trends, including continued reimbursement pressure, hospitals may change their approach to providing clinical testing services.
−Removed: New industry entrants with extensive resources (e.g., private equity firms) may make acquisitions or expand into our traditional areas of operations.
+Added: New industry entrants with extensive resources ( e.g.
+Added: , private equity firms) may make acquisitions or expand into our traditional areas of operations.
Healthcare utilization
Healthcare utilization in the United States has fluctuated based on a number of factors.
−Removed: These factors include, without limitation, the economy, healthcare benefits design, patients delaying medical care, and increased consumer financial responsibility for, interest in and control of their healthcare.
+Added: These factors include, without limitation, the economy, healthcare benefits design, patients delaying medical care, increased consumer financial responsibility for, interest in and control of their healthcare, and efforts by non-governmental third-party payers, including health plans, to reduce utilization of and reimbursement for clinical testing services.
Reimbursement pressure;
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Healthcare market participants, including governments, are focused on controlling costs.
−Removed: Examples of cost control approaches include reducing reimbursement for healthcare services, changing reimbursement methodology for healthcare services (e.g., shift from fee for service to capitation), changing medical coverage policies (e.g., healthcare benefits design), denying coverage for services, requiring preauthorization of laboratory testing, requiring co-pays, introducing laboratory spend management utilities and payment and patient care innovations such as ACOs and patient-centered medical homes.
+Added: Examples of cost control approaches include reducing reimbursement for healthcare services, changing reimbursement methodology for healthcare services ( e.g.
+Added: , shift from fee for service to capitation), changing medical coverage policies ( e.g.
+Added: , healthcare benefits design), denying coverage for services, requiring preauthorization of laboratory testing, requiring co-pays, introducing laboratory spend management utilities and payment and patient care innovations such as ACOs and patient-centered medical homes.
There is increased market activity regarding alternative payment models, including bundled payment models.
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healthcare payment reform and cost transparency are significant issues.
−Removed: The FDA and HHS have expressed views regarding the regulation of LDTs.
−Removed: Legislation previously introduced in Congress in 2022 and again in 2023 that would authorize the FDA to regulate LDTs has not become law.
−Removed: In October 2023, the FDA announced a proposed rule that would broaden the definition of medical device to include diagnostic tests and laboratories that develop them.
−Removed: Publication of a final rule initiates a four-year period for a staged process of compliance and submissions.
−Removed: The proposed rule could also impact a revitalization and passage of legislation that authorizes the FDA to regulate LDTs by amending the Food, Drug and Cosmetic Act.
−Removed: If either the rule or legislation were to become law, it could have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating new avenues of opportunity and competition regarding clinical laboratory testing.
−Removed: New competitors may enter the industry, and competition may come in new forms.
−Removed: From time to time, the federal government has considered whether competitive bidding could be used to provide clinical testing services for Medicare beneficiaries while maintaining quality and access to care.
−Removed: Congress periodically considers cost-saving initiatives.
−Removed: These initiatives have included coinsurance for clinical testing services, co-payments for clinical testing and further laboratory physician fee schedule reductions.
+Added: The FDA has regulatory responsibility over, among other areas, instruments, software, test systems, collection kits, reagents and other devices used by clinical laboratories to perform diagnostic testing in the United States.
+Added: The FDA also regulates drugs-of-abuse testing for employers and insurers, testing for blood bank purposes and testing of donors of human cells for purposes such as in vitro fertilization.
+Added: We offer companion diagnostic testing services to pharmaceutical companies that are regulated by the FDA.
+Added: As of May 6, 2024, the FDA announced it was phasing out its general enforcement discretion approach so that LDTs manufactured by a laboratory will generally fall under the same enforcement approach as medical devices.
+Added: A number of advanced tests we develop internally are offered as LDTs.
+Added: Pursuant to the FDA’s decision to remove enforcement discretion with regard to most LDTs performed by high complexity CLIA-certified laboratories like ours, all new and significantly modified previously offered laboratory tests that do not benefit from continued enforcement discretion will have to comply with the Food, Drug and Cosmetic Act (the "FDCA") over a four-year, five-stage process.
+Added: Compliance with the FDCA includes, among other things, new quality system regulations and premarket authorization.
+Added: One major area of the continued FDA enforcement discretion will apply to many tests that were offered for clinical use prior to May 6, 2024 and that do not afterwards undergo certain material modifications.
+Added: The removal of enforcement discretion for LDTs could result in a revitalization and passage of legislation or other Congressional action.
+Added: The current FDA policy to remove enforcement discretion and/or new legislation is expected to have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating new avenues of opportunity and competition regarding clinical laboratory testing.
Use of healthcare data;
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Healthcare services delivery Healthcare delivery is moving out of hospitals, clinician offices and other traditional locations into new settings, such as outpatient, retail, consumer-focused, telemedicine and home settings.
−Removed: This dynamic offers new opportunities (e.g., mobile phlebotomy services) and challenges for healthcare providers.
−Removed: We are seeking opportunities to provide diagnostic information services to these new healthcare service providers.
+Added: This dynamic offers new opportunities ( e.g.
+Added: , mobile phlebotomy services) and challenges for healthcare providers.
+Added: We are seeking opportunities to provide diagnostic information services to healthcare providers and consumers.
We believe that these changing market fundamentals will benefit lower-cost, high-value providers like Quest, and that we are well positioned to grow from the changing market conditions and benefit from the long-term growth expected in the industry.
1 unchanged sentence
We provide diagnostic information services to a broad range of customers within our primary customer channels of physicians, hospitals, and patients and consumers.
−Removed: In many cases, the individual that orders our services is not responsible for paying for these services.
+Added: While in many cases, the individual that orders our services is not responsible for paying for these services, consumers are more frequently requesting and paying for tests themselves.
Increasingly, patients are bearing greater responsibility for some portion of the payment for the services we provide to them, even if a third party is primarily responsible for payment.
−Removed: In addition, consumers are more frequently requesting and paying for tests themselves.
In the table below, we provide a summary of our different customer channels.
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For more information see "Our Strategy --Physicians".
−Removed: In recent years, there has been a marked increase in the number of physician practices owned by hospitals.
+Added: There has been a marked increase in the number of physician practices owned by hospitals and other companies.
There also has been a notable increase in some branches of medicine of the establishment of very large "rolled-up" physician practice groups.
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For example, ACOs may be encouraged to consider exclusive arrangements with healthcare providers, or to limit service providers.
−Removed: The Medicare Sharing Savings Program for ACOs is a critical component of CMS' vision to advance health equity, drive high-quality, person-centered care and promote affordability and sustainability of the Medicare program.
+Added: The Medicare Sharing Savings Program for ACOs is a critical component of CMS' vision to drive high-quality, person-centered care and promote affordability and sustainability of the Medicare program.
CMS sponsors two additional programs for ACOs, has stated that its goal is for all people in traditional Medicare to be in an ACO by 2030, and is adopting policies to drive growth in ACO participation.
We believe that our experience with value-based arrangements with other payers positions us as a strong partner for ACOs.
−Removed: In addition, we believe that our extended care experience and population health capabilities are attractive to ACOs, and that our Quest for Health Equity ® initiative underscores our commitment to health equity important to ACOs.
+Added: In addition, we believe that our extended care experience and population health capabilities are attractive to ACOs.
FQHCs are non-profit, community-directed organizations that offer care to medically underserved patients;
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We also offer a tiered, flexible approach to gaps-in-care programs that helps complement FQHC efforts to emphasize preventive care.
−Removed: Our Quest for Health Equity ® initiative also demonstrates our commitment to FQHCs and the people they serve;
−Removed: many of these initiatives support FQHCs, including by providing donated testing services.
−Removed: For more information about our Quest for Health Equity ® initiative, see “ – Our Strengths”.
Hospitals We believe that we are an industry leader in servicing hospitals and serve approximately half the hospitals in the United States each year in many ways.
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Employers Employers use tests for drugs of abuse to determine an individual's employability and “fitness for duty.” Companies with high levels of employee hiring, safety conscious environments or regulatory testing requirements provide the highest volumes of testing.
−Removed: Factors such as the general economy, the job market and changes in the legal environment (e.g., marijuana legalization or decriminalization) can impact the utilization of drugs-of-abuse testing.
+Added: Factors such as the general economy, the job market and changes in the legal environment ( e.g.
+Added: , marijuana legalization or decriminalization) can impact the utilization of drugs-of-abuse testing.
Some employers retain third-party administrators to handle such testing and related services;
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These providers include "big-box" retailers, pharmacy chains, supermarkets, urgent care centers and Internet-based service providers.
−Removed: We are taking advantage of opportunities to work with these providers, not only to offer new access partners (e.g., Rite-Aid retail locations) and new access points for our services (e.g., our collaboration with Safeway), but also to grow our business by expanding our service offerings (e.g., our collaborations with CVS and Walmart).
+Added: We are taking advantage of opportunities to work with these providers, not only to offer new access partners and new access points for our services ( e.g.
+Added: , our collaboration with Safeway), but also to grow our business by expanding our service offerings ( e.g.
+Added: , our collaborations with CVS and Walmart).
Pharmaceutical companies We offer clinical trials testing and have expertise with LDTs for companion and complementary diagnostics, and offer an array of assets and services to support the development of companion diagnostics, including our robust data set and patient services network.
1 unchanged sentence
In addition, we offer Quest Clinical Trials Connect TM to help accelerate clinical trials (and thus the speed of drugs to market) through better patient recruitment, involvement and management, and improved physician outreach.
−Removed: We also offer Pack Health's patient engagement services.
Other Commercial Clinical Laboratories We also provide services on a fee-for-service basis to other commercial clinical laboratories.
Health Plans, Government Agencies and Other Payers
−Removed: Most of the services we perform are paid for by commercial payers, including large national health plans, managed care organizations and other health insurance providers, regional and local health plans and government payers, which includes Medicare and Medicaid.
+Added: Most of the services we perform are paid for by third-party payers, including large national health plans, managed care organizations and other health insurance providers, regional and local health plans and government payers, which includes Medicare and Medicaid.
These customers typically reimburse us as a contracted (or out-of-network) provider for services rendered to their members.
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Reimbursement from our five largest health plans totaled approximately 20%, and no one health plan accounted for 10%, of our consolidated net revenues in 2024.
−Removed: Health plans typically negotiate directly or indirectly with a number of diagnostic information services providers, and represent approximately one-half of our total clinical testing volume and > 40% of our net revenues from diagnostic information services.
+Added: Health plans typically negotiate directly or indirectly with a number of diagnostic information services providers, and represent approximately one-half of our total clinical testing volume and approximately 40% of our net revenues from diagnostic information services.
There has been a trend of consolidation among health plans.
Some health plans also have narrowed their provider networks.
−Removed: In addition, some health plans have established "preferred provider" networks within their broader networks (e.g., UnitedHealthcare's Preferred Lab Network), in effect distinguishing among contracted providers.
+Added: In addition, some health plans have established "preferred provider" networks within their broader networks ( e.g.
+Added: , UnitedHealthcare's Preferred Lab Network), in effect distinguishing among contracted providers.
We are also sometimes a member of a “complementary network.” A complementary network generally is a set of contractual arrangements that a third party maintains with various providers that provide discounted fees for the benefit of its customers.
−Removed: A member of a health plan
−Removed: may choose to access a non-contracted provider that is a member of a complementary network;
−Removed: if so, the provider will be reimbursed at a rate negotiated by the complementary network.
−Removed: We offer to health plans services and programs that leverage our Company's expertise and resources, including our superior patient access, extensive test menu, medical staff, data, IT solutions, and wellness and population health management capabilities.
+Added: A member of a health plan may choose to access a provider not contracted directly by their health plan but contracted with a complementary network.
+Added: In such instance, the provider will be reimbursed at a rate negotiated by the complementary network.
+Added: We offer to health plans services and programs that leverage our Company's expertise and resources, including our superior patient access, comprehensive test menu, medical staff, data, IT solutions, and wellness and population health management capabilities.
For the last few years, our Company has had access to a very high percentage of the insured lives in the United States, including very strong access in key high-population states.
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Over the last several years, the federal government has expanded its contracts with private health insurance plans for Medicare beneficiaries and has encouraged such beneficiaries to switch from the traditional programs to the private programs, called “Medicare Advantage” programs.
−Removed: There has been growth of health insurance providers offering Medicare Advantage programs and of beneficiary enrollment in these programs.
+Added: There has been growth of health insurance providers offering
+Added: Medicare Advantage programs and of beneficiary enrollment in these programs.
States also have mandated that Medicaid beneficiaries enroll in private managed care arrangements.
We also provide additional services to and in conjunction with government agencies across the United States.
−Removed: For example, in 2023, we formed a novel collaboration with the CDC to research the disease burden of hepatitis C virus in the United States based on our laboratory testing.
+Added: For example, in 2024, we were awarded several contracts by the CDC to support testing and sustained laboratory readiness for two emerging infectious diseases.
+Added: The arrangements will support the preparedness for certain viruses by ensuring a national commercial laboratory provider is able to quickly supplement public health laboratories in the event there is an infectious disease outbreak in people.
While there has been consolidation in the diagnostic information services industry in recent years, which we expect to continue, our industry remains fragmented and highly competitive.
We primarily compete with three types of clinical testing providers:
−Removed: other commercial clinical laboratories, including smaller regional and local commercial clinical laboratories and specialized advanced laboratories, hospital-affiliated laboratories and physician-office laboratories.
+Added: other commercial clinical laboratories, including smaller regional and local commercial clinical laboratories and specialized advanced laboratories;
+Added: hospital-affiliated laboratories;
+Added: and physician-office laboratories.
Our largest commercial clinical laboratory competitor is Laboratory Corporation of America Holdings, Inc.
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Hospitals that own physician practices may encourage or require the practices to refer testing to the hospital's laboratory.
−Removed: In recent years, there has been a trend of hospitals acquiring physician practices, increasing the percentage of physician practices owned by hospitals.
+Added: There has been a trend of hospitals acquiring physician practices, increasing the percentage of physician practices owned by hospitals.
Increased hospital ownership of physician practices may enhance clinician ties to hospital-affiliated laboratories and may strengthen their competitive position.
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government agencies) and market activity may continue to increase the competitive environment.
−Removed: We believe that providing the most attractive service offering in the industry, including the most comprehensive test menu, innovative test offerings, a positive customer experience, a staff including medical and scientific experts, high quality, leading access and distribution, and data-powered integrated IT solutions provide us with a competitive advantage.
+Added: We believe that providing the most attractive service offering in the industry, including the most comprehensive test menu, innovative test offerings, a positive customer experience, deep medical and scientific expertise, high quality, leading access and distribution, and data-powered integrated IT solutions provide us with a competitive advantage.
We believe that as a large diagnostic information services provider we can serve our customers more effectively due to our larger network and lower cost structure.
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Competitors also may compete on the basis of new service offerings.
−Removed: Competitors also may offer new testing services that can be performed outside of a commercial
−Removed: clinical laboratory, such as point-of-care testing that can be administered by physicians in their offices, complex testing that can be performed by hospitals in their own laboratories, and home testing that can be carried out without requiring the services of outside providers.
+Added: Competitors also may offer new testing services that can be performed outside of a commercial clinical laboratory, such as point-of-care testing that can be administered by physicians in their offices, complex testing that can be performed by hospitals in their own laboratories, and home testing that can be carried out without requiring the services of outside providers.
The risk assessment and healthcare IT industries are highly competitive.
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Our focus on delivering across The Quest Way drives our approach to human capital management.
−Removed: Effectively managing our human capital resources is a priority with key components that include culture, safety and well-being programs, inclusion, diversity, and employee engagement, and attracting, training, development and succession planning.
+Added: Effectively managing our human capital resources is a priority with key components that include culture, safety and well-being programs, and employee engagement, and attracting, training, development and succession planning.
Our Board of Directors oversees our human capital management, including by receiving management reports on key areas, strategies, and initiatives.
−Removed: In 2023, our Board of Directors renamed the Compensation Committee the Compensation and Leadership Development Committee and revised the committee’s charter to include leadership development for senior management other than the Chief Executive Officer, as a committee responsibility.
Additional information about our human capital management strategies and initiatives is available in our annual corporate responsibility report.
−Removed: As of December 31, 2023, we have approximately 48,000 employees, of whom approximately 40,000 are full-time and the remainder are part-time or on-call.
+Added: As of December 31, 2024, we have approximately 56,000 employees globally (including LifeLabs’ approximately 6,600), of whom approximately 45,000 are full-time and the remainder are part-time or on-call.
Our employee population is more diverse than the U.S.
workforce, taken as a whole.
−Removed: Approximately 72% of our employees globally identify as women;
−Removed: approximately 50% of our U.S.
−Removed: employees identify as people of color.
+Added: Approximately 70% of our employees globally are women (including approximately 75% at LifeLabs);
+Added: approximately 50% of our global team are diverse.
A majority of our employees work directly with our customers or in our laboratories.
−Removed: Fewer than 1% of our employees are represented by a union.
+Added: Fewer than 1% of our U.S.
+Added: employees are represented by a union.
We believe that our overall relations with our employees are good.
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In 2023, we introduced The Quest Way and the 5Cs of Culture —Customer First, Care, Curiosity, Collaboration and Continuous Improvement—to define the behaviors we value and aspire to, every day.
−Removed: The 5Cs are integrated into our daily management practices, including recognition and performance reviews, to encourage all employees to embody the 5Cs in their daily activities.
+Added: The 5Cs are integrated into our daily management practices, including recognition, training and performance reviews, to encourage all employees to embody the 5Cs in their daily activities.
+Added: We understand the need to create an environment where employees can bring their whole selves to work, and our philosophy embodies our commitment to promote inclusion and diversity by consistently inviting new perspectives and exploring new experiences.
+Added: We aim to harness the unique mix of capabilities, talents, cultures, beliefs and experience of our employees and create a workforce that feels comfortable sharing these perspectives.
+Added: We focus on Culture, Talent and Community across the entire talent lifecycle and prioritize supporting all employees throughout their careers at Quest.
+Added: We continue to prioritize our leadership training programs supporting early careerists, mid-career managers and senior executives.
+Added: Additionally, we launched a council comprised of leaders from our Employee Business Networks to offer regular feedback to organizational leaders on opportunities to further enhance our culture.
Our Quest Management System, supports our effort to maintain a focus on high performance.
−Removed: We also focus on building and maintaining a collaborative, diverse and inclusive culture in which all employees are empowered to raise and discuss difficult issues and are valued for their strengths, experience and unique perspectives (our focus on diversity and inclusion is discussed further below).
+Added: We also focus on building and maintaining a collaborative, diverse and inclusive culture in which all employees are empowered to raise and discuss difficult issues and are valued for their strengths, experience and unique perspectives.
We encourage our employees to actively participate in their communities, and support their participation, through our Employee Business Networks and Matching Gift Program.
−Removed: Our Everyday Excellence program includes guiding principles for our entire organization to support a superior customer experience and inspire employees to be their best every day, with every person and with every customer interaction;
−Removed: the program is integrated into performance assessments and frontline employee behavioral standards.
+Added: Our Everyday Excellence program elevates our focus on the 5C of Customer First through guiding principles for our entire organization to support a superior customer experience and inspire employees to be their best every day, with every person and with every customer interaction;
+Added: the program is integrated into frontline employee behavioral standards.
Our Recognition Quest Program reinforces our commitment to recognize above and beyond contributions and to demonstrating how much we value, care for and appreciate one another by regularly celebrating and rewarding one another as we work together.
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We also offer comprehensive medical and mental health plans.
−Removed: For example, our mental health support service, launched in 2022, continues to be widely used among our employees and their dependents.
−Removed: HealthyQuest™ focuses on prevention, progression
−Removed: and reversal, through which we offer a HealthyQuest™ Employee Business Network and intervention programs designed to engage employees in managing their health, including access to medical expertise and support programs tailored to their individual needs, helping them to adopt healthier behaviors and access better care at lower costs.
−Removed: These programs include customized programs for conditions such as type 2 diabetes management, chronic kidney disease, cardiovascular disease, specialty drugs, and zero-cost lab testing, and special support for orthopedic surgery and for cancer and other serious diagnoses.
−Removed: Inclusion and Diversity .
−Removed: We understand the need to create an environment where employees can bring their whole selves to work, and our Everyday Equity philosophy embodies our commitment to promote inclusion and embrace diversity by consistently inviting new perspectives and exploring new experiences.
−Removed: We aim to harness the unique mix of capabilities, talents, cultures, beliefs and experience of our employees and create a workforce that is demographically diverse at all levels of the organization.
−Removed: Through our focus on Culture, Talent and Community, we prioritize diversity across the entire talent lifecycle, with the goals of supporting employees throughout their careers at Quest, ensuring transparency and identifying opportunities for action.
−Removed: In 2023, we expanded our focus on inclusion and diversity through leadership training programs like McKinsey Connected Leaders Academy, Franklin Covey’s Leading at the Speed of Trust, and a Mentoring Circles program focused on developing inclusive leadership competencies in front line supervisors.
−Removed: Additionally, we launched an Everyday Equity Council comprised of diverse leaders from our Employee Business Networks to offer regular feedback to organizational leaders on opportunities to further enhance inclusivity of programs, policies, and services.
−Removed: Our employee engagement on Inclusion and Diversity was also evidenced by the approximately 60% growth in Employee Business Network membership in 2023.
−Removed: We also continued, with the Quest Diagnostics Foundation, Quest for Health Equity ® , our initiative to help reduce health disparities in underserved communities.
−Removed: For more information about our Quest for Health Equity ® initiative, see "-Our Strengths".
+Added: For example, our mental health support service, launched in 2022, is widely used among our employees and their dependents.
+Added: HealthyQuest™ focuses on prevention, progression and reversal, through which we offer a HealthyQuest™ Employee Business Network and intervention programs designed to engage employees in managing their health, including access to medical expertise and support programs tailored to their individual needs, helping them to adopt healthier behaviors and access better care at lower costs.
+Added: These programs include customized
+Added: programs for conditions such as type 2 diabetes management, chronic kidney disease, cardiovascular disease, specialty drugs, weight management, zero-cost lab testing, and special support for orthopedic surgery and for cancer and other serious diagnoses.
Actively listening to our employees is fundamental to Quest’s culture.
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This approach is designed to build an agile culture, based on continuous feedback that fuels ongoing conversations about priorities, performance, opportunities and growth, to result in a higher performing organization and committed employees.
−Removed: To gain deeper insights from our employees, we expanded our effort across the employee lifecycle, to gain the unique feedback of our new hires, newly acquired team members, and our departing colleagues.
−Removed: In addition, we hold regular meetings among hundreds of company leaders to foster increased communication across the company regarding topics of concern to employees.
+Added: To gain deeper insights, we expanded our 2024 program to include a culture insights survey, providing an enterprise-wide view of the employee experience in relation to our Purpose and the 5Cs.
+Added: This is complemented by team-level insights from our employee insights, and lifecycle surveys for new hire and departing staff.
+Added: In addition, we hold regular monthly meetings among hundreds of company leaders to foster increased communication across the company regarding topics of concern to employees.
Attracting, Training, Development and Succession Planning .
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For example, we are partnering with universities and specialized healthcare schools to help build our pipeline of expertise in medical technology, cytology and histology, and we have teamed up with a third-party phlebotomy training program to train and certify phlebotomist candidates who can join our ranks upon graduation.
−Removed: In addition, we post all our jobs on a number of sites that specifically attract diverse talent.
We provide training on a wide array of topics to our employees through live and online formats, including opportunities that can be accessed through their mobile devices.
We also offer a number of development opportunities for our employees through a robust library of offerings in our Learning Management System, EMPower.
−Removed: We also facilitate mentoring and education programs and a higher education tuition assistance program, My Quest for Education.
−Removed: In addition, we provide leadership training opportunities for employees at all levels, including a manager essentials curriculum, our Leading Quest Supervisor and Manager Core Program, our director-level Leading Quest for Business Impact program, coaching programs and trainings to strengthen critical leadership skills.
−Removed: We also deliver a number of programs tailored to specific functions to drive a high-performance culture and sharpen the capabilities needed to lead our organization ( e.g ., our Commercial, Finance, Pathology, R&D, and Product Management Leadership Programs).
+Added: We also offer mentoring and education programs, including a higher education tuition assistance program, My Quest for Education.
+Added: Among participants in the My Quest for Education program, 52% have received promotions and 34% have made lateral career moves.
+Added: In 2024, we introduced INSPIRE, a frontline development program focused on enhancing service excellence for our customer-facing employees.
+Added: In addition, we provide leadership training opportunities for employees at all levels, including a manager essentials curriculum, our Leading Quest Supervisor and Manager Core program, our director-level Leading Quest for Business Impact program, Financial Acumen for Business Leaders, leadership coaching programs and trainings to strengthen critical leadership skills.
+Added: We also deliver a number of programs tailored to specific functions to drive a high-performance culture and sharpen the capabilities needed to lead our organization ( e.g ., programs focused on Commercial, Finance, Pathology, R&D, and Product Development).
Quest’s robust talent review and succession planning process assesses current and future organizational needs in combination with the capabilities and aspirations of our employees to ensure we have the right talent, in the right roles, at the right time.
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CAP offers an accreditation program to which clinical laboratories may voluntarily subscribe.
−Removed: All of our major laboratories, including our laboratories outside the United States, and a number of our rapid response laboratories, are accredited by CAP.
+Added: All of our major laboratories, including our laboratories outside the United States, a number of our rapid response laboratories, and our biorepository facility are accredited by the CAP.
Accreditation includes on-site inspections and participation in the CAP (or equivalent) proficiency testing program.
In addition, some of our laboratories also have International Organization for Standardization (ISO) certification for their quality management systems.
−Removed: For example, in 2022, we achieved ISO 14001 certification for our esoteric laboratory facility at San Juan Capistrano, CA.
+Added: For example, in 2023, we achieved ISO 14001 certification for our Cleveland HeartLab and laboratory facility in Chantilly, VA.
ISO 14001 is an internationally recognized management system that leverages leadership involvement and employee engagement to help organizations ensure compliance with regulatory standards, improve their environmental performance, provide a competitive advantage and gain the trust of stakeholders, and achieve strategic goals by incorporating environmental issues into business management.
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We expect suppliers to provide the highest quality products and services and to embrace an ethic of transparent quality collaboration.
−Removed: In our program, we aim to ensure and improve the quality of purchased products and services.
+Added: In our Supplier Quality Program, we aim to ensure and improve the quality of purchased products and services.
Our suppliers are expected to operate under quality management principles that meet industry standards, strive for zero defect manufacturing, use statistical analysis to reduce variation and meet applicable regulatory standards.
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We use supplier quality engineers who are trained to audit on ISO standards and FDA regulations applicable to suppliers’ processes, and a procurement engineering team to assist with qualification and validation of new supplies and products.
−Removed: We actively manage supplier performance, utilizing a problem reporting and resolution process designed to drive to root cause and
−Removed: corrective actions.
+Added: We actively manage supplier performance, utilizing a problem reporting and resolution process designed to drive to root cause and corrective actions.
We maintain a continuous improvement dialogue with our suppliers, and with operationally critical suppliers deliver a supplier scorecard that supports continuous improvement.
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We maintain an enterprise risk management program, which is led by our executive leadership and overseen by our Board of Directors, that is designed to promote a culture of risk awareness throughout the Company's key business, operations and support functions.
−Removed: Our program, which is integrated with the Company’s governance, performance management and internal control frameworks, entails a formal continuous process that identifies, assesses, mitigates and manages the risks from both internal and external conditions that could significantly impact the Company and influence its business strategy and performance, including environmental, social and governance issues.
+Added: Our program, which is integrated with the Company’s governance, performance management and internal control frameworks, entails a formal continuous process that identifies, assesses, mitigates and manages the risks from both internal and external conditions that could significantly impact the Company and influence its business strategy and performance.
The program, which is managed by an enterprise risk management team, is designed based on the most recent framework issued by the Committee of Sponsoring Organizations of the Treadway Commission, and we benchmark it against best practices.
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Unfortunately, as a result of a flawed implementation of PAMA, the data collected did not accurately represent the laboratory market as required under PAMA.
−Removed: Independent laboratories were overrepresented, and hospitals and physician office laboratories were underrepresented, making the first round of PAMA cuts too extreme and resulting in below market rates.
+Added: Independent laboratories were overrepresented, and hospitals and physician office laboratories were underrepresented, making the first round of PAMA cuts too extreme.
+Added: The three years of cuts exceeded the original 10-year savings projections.
PAMA calls for further revision of the Medicare CLFS for years after 2020, based on future surveys of market rates.
−Removed: PAMA's next data collection and reporting period have been delayed, most recently by federal legislation adopted in November 2023 (the Further Continuing Appropriations and Other Extensions Act of 2024), which further delayed the reimbursement rate reductions and reporting requirements until January 1, 2025;
+Added: Congress has delayed cuts five times (2021 - 2025) and delayed 2019 reporting six times (2020 - 2025).
Reimbursement rate reduction from 2026-28 is capped by PAMA at 15% annually.
−Removed: Congress reintroduced federal legislation in 2023 (the Saving Access to Laboratory Services Act), which, if enacted, would reform PAMA and create a true market-based CLFS.
+Added: Congress reintroduced federal legislation in 2023 (the Saving Access to Laboratory Services Act), which would reform PAMA and create a true market-based CLFS.
We are subject to extensive and frequently changing laws and regulations in the United States (at both the federal and state levels) and other jurisdictions in which we conduct business, and to government inspections and audits.
Key Regulatory Schemes
−Removed: CLIA and State Clinical Laboratory Licensing CLIA regulates the operations of virtually all clinical laboratories, requiring that they be certified by the federal government and that they comply with various technical, operational, personnel and quality requirements intended to ensure that the services provided are accurate, reliable and timely.
+Added: CLIA and State Clinical Laboratory Licensing CLIA regulates the operations of virtually all clinical laboratories, including our laboratories in the United States, requiring that they be certified by the federal government and that they comply with various technical, operational, personnel and quality requirements intended to ensure that the services provided are accurate, reliable and timely.
State laws may require additional personnel qualifications or licenses, quality control, record maintenance, proficiency testing or detailed review of our scientific method validations and technical procedures for certain tests.
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Violations of these laws and regulations may result in monetary fines, criminal and civil penalties and/or suspension or exclusion from participation in Medicare, Medicaid and other federal or state healthcare programs.
−Removed: FDA The FDA has regulatory responsibility over, among other areas, instruments, software, test kits, reagents and other devices used by clinical laboratories to perform diagnostic testing in the United States.
+Added: FDA The FDA has regulatory responsibility over, among other areas, instruments, software, test systems, collection kits, reagents and other devices used by clinical laboratories to perform diagnostic testing in the United States.
The FDA also regulates drugs-of-abuse testing for employers and insurers, testing for blood bank purposes and testing of donors of human cells for purposes such as in vitro fertilization.
+Added: We offer companion diagnostic testing services to pharmaceutical companies that are regulated by the FDA.
+Added: As of May 6, 2024, the FDA announced it was phasing out its general enforcement discretion approach so that LDTs manufactured by a laboratory will generally fall under the same enforcement approach as medical devices.
A number of advanced tests we develop internally are offered as LDTs.
−Removed: The FDA has claimed regulatory authority over all LDTs, but has stated that it exercised enforcement discretion with regard to most LDTs performed by high complexity CLIA-certified laboratories.
−Removed: The FDA and HHS have expressed views regarding the regulation of LDTs including the FDA’s jurisdiction over them.
−Removed: Previously proposed legislation introduced in Congress that would have authorized the FDA to regulate LDTs has not become law.
−Removed: In October 2023, the FDA announced a proposed rule that would broaden the definition of medical device to include diagnostic tests and laboratories that develop them.
−Removed: Publication of a final rule initiates a four-year period for a staged process of compliance and submissions.
−Removed: The proposed rule could also impact a revitalization and passage of legislation that authorizes the FDA to regulate LDTs by amending the Food, Drug and Cosmetic Act.
−Removed: If either the rule or legislation were to become law, it could have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating new avenues of opportunity and competition regarding clinical laboratory testing.
−Removed: New competitors may enter the industry, and competition may come in new forms.
+Added: Pursuant to the FDA’s decision to remove enforcement discretion with regard to most LDTs performed by high complexity CLIA-certified laboratories like ours, all new and significantly modified previously offered laboratory tests that do not benefit from continued enforcement discretion will have to comply with the FDCA over a four-year, five-stage process.
+Added: Compliance with the FDCA includes, among other things, new quality system regulations and premarket authorization.
+Added: One major area of the continued FDA enforcement discretion will apply to many tests that were offered for clinical use prior to May 6, 2024 and that do not afterwards undergo certain material modifications.
+Added: The removal of enforcement discretion for LDTs could result in a revitalization and passage of legislation or other Congressional action.
+Added: The current FDA policy to remove enforcement discretion and/or new legislation is expected to have a significant impact on the clinical laboratory testing industry, including regulating LDTs in new ways, while creating new avenues of opportunity and competition regarding clinical laboratory testing.
Environmental, Health and Safety We are subject to laws and regulations related to the protection of the environment, the health and safety of employees and the handling, transportation and disposal of medical specimens, infectious and hazardous waste and radioactive materials.
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(b) state laws (e.g., California) and similar laws in other states;
−Removed: and (c) laws outside the U.S., including the European Union's General Data Protection Regulation and similar laws in other jurisdictions.
+Added: and (c) laws outside the U.S., including the European Union's General Data Protection Regulation, Canada’s Personal Information Protection and Electronic Documents Act and provincial health privacy laws, and similar laws in other jurisdictions.
We may be subject to penalties for non-compliance and may be required to notify individuals or state, federal or county governments if we discover certain breaches of personal information or protected health information.
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• Statements of beneficial ownership of our equity securities filed by our directors, officers and others under Section 16 of the Exchange Act
−Removed: We also maintain a Corporate Responsibility webpage that provides information about our corporate responsibility program, including our focus on environmental, social and governance issues and our annual Corporate Responsibility Report.
+Added: We also maintain a Corporate Responsibility webpage that provides information about our corporate responsibility program, including our efforts related to community giving, governance and sustainability and our annual Corporate Responsibility Report.
www.QuestDiagnostics.com/our-company/corporate-responsibility provides information about our corporate responsibility program.
1 unchanged sentence
• Corporate Responsibility Reports
−Removed: • Quest for Health Equity ®
−Removed: • Information about our corporate political contributions
• Quest Diagnostics Foundation
−Removed: • Environmental, social and governance resources
+Added: • Information about our corporate political contributions
• Sustainability
−Removed: • Governance, ethics and values
+Added: • Corporate responsibility resources
• Community giving
+Added: • Governance, ethics and values
INFORMATION ABOUT OUR EXECUTIVE OFFICERS
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Delaney served in a number of senior sales and marketing leadership roles at General Electric's healthcare business, most recently as Senior Vice President and Zone Manager, where he had regional responsibility for sales of imaging, patient monitoring, IT and services.
−Removed: Senior Vice President, Regional Businesses Since March 2022, Ms.
+Added: Executive Vice President, Regional Businesses Since March 2022, Ms.
Doherty has been responsible for the general management of the Company's regional Diagnostic Information Services business, the commercial organization and marketing.
She also is responsible for driving operational excellence, including the Company's quality and efficiency initiatives.
−Removed: Doherty is the Executive Sponsor of the Company's Women in Leadership Employee Business Network and was formerly co-chair of the Company's Inclusion and Diversity Council.
+Added: Doherty is the Executive Sponsor of the Company's Women in Leadership Employee Business Network.
From January 2020 to January 2023, she was responsible for consumer-initiated testing, which was launched under her leadership.
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and Chief Accounting Officer.
−Removed: Gardner (58), Senior Vice President, Molecular Genomics and Oncology Mr.
−Removed: Gardner joined the Company in October 2022 in his current role.
−Removed: He is responsible for oncology, pathology, specialty genetics, and research and development.
−Removed: Gardner joined Quest from Corza Medical, a provider of surgical technologies and tools, where he served since 2019 as Executive Partner, Senior Vice President and General manager of European Commercial Operations and Biosurgery Products.
−Removed: Prior to that, Mr.
−Removed: Gardner served as Chief Executive Officer of OmniSeq Corporation, a molecular diagnostics company, from 2016 to 2019 and in Vice President and General Manager positions at Thermo Fisher Scientific Inc.
−Removed: from 2003 to 2016, including roles with Life Technologies and Invitrogen.
−Removed: He began his career as a consultant with McKinsey and Company, Inc.
+Added: During 2024 she assumed responsibility for the anatomic pathology business branded AmeriPath and retained all other responsibilities except marketing.
Karthik Kuppusamy (55)
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Cardiovascular, Metabolic, Endocrinology and Wellness, Drug Monitoring and Toxicology, Infectious Disease and Immunology, Neurology, and Women’s and Reproductive Health.
−Removed: He is also responsible for the Company's pharmaceutical services, genomic customer services, medical affairs, medical quality and regulatory.
−Removed: Kuppusamy serves as co-chair of the Company's Inclusion and Diversity Council.
+Added: He is also responsible for the Company's genomic customer services, medical affairs, regulatory, LifeLabs and global markets.
Previously, Mr.
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Plewman assumed his current role in April 2022.
−Removed: He is responsible for a portfolio of data driven analytics and services offerings, including Employer Population Health, Healthcare Analytic Solutions, Pack Health, Risk Assessment (ExamOne) and Employer Solutions.
+Added: He is responsible for a portfolio of data driven analytics and services offerings, including Workforce Health Solutions, Healthcare Analytic Solutions, Pack Health, Risk Assessment (ExamOne), Consumer Initiated Testing and Pharma Services.
Since joining the Company in 2013, Mr.
Plewman was Vice President and General Manager of the Company's Diagnostic Information Services Business in its West Region since 2018 and previously served as General Manager of the Company's Cardiovascular, Metabolic and Endocrinology Franchise, General Manager of the Company's Infectious Disease and Immunology Franchise and General Manager of the General Health and Wellness Franchise.
+Added: Plewman serves as Executive Co-Sponsor of the HealthyQuest™ Employee Business Network.
Prior to joining the Company, Mr.
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In 2003, he assumed responsibility for governmental affairs.
−Removed: Prevoznik also is the Executive Co-Sponsor of the Company's Quest for Health Equity ® Initiative.
+Added: Prevoznik also is the Vice Chair of the Quest Foundation.
From 1999 until April 2009, Mr.
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.