Journal of Applied Laboratory Medicine最新文献

Background: The clinical laboratory provides critical information by which medical decisions are made. However, few understand the effort and support required to deliver high-quality results. This has led to unfavorable federal legislation that threatens the ability of laboratorians to be innovative and advance the field.

Methods: A social media campaign was launched in late 2023 in an attempt to educate the general public as to the value of the clinical lab in hopes of reversing this trend. Featured topics include clinical chemistry, microbiology, toxicology, molecular diagnostics, and clinical microbiology.

Results: To date, 26 posts have been made via a popular social media site. Each of these videos is between 2 and 3 minutes long and features an individual who endures a medical condition or medicolegal situation where clinical laboratory results are central to the outcome of the case. Using social media vernacular, the popularity of these videos is reflected by the number of "views," "likes," and "followers." To date, these values are 5 million, 86 000, and 44 000, respectively. It is difficult if not impossible to objectively document the long-term impact of this social media campaign on the profession.

Conclusions: An alternative means of promoting the field of laboratory medicine is required if the field is to be adequately funded and staffed to meet current and future testing goals.

Background: The US healthcare system is complex and includes a number of entities and systems that provide services to patients and to pay for them. While improving health and well-being are accepted goals of healthcare, the 3 stakeholder groups relevant to healthcare-patients, providers, and payers-often have different perspectives on how care should be utilized, performed, and paid for. These differing perspectives are discussed as they relate to clinical laboratory testing.

Content: Patients expect that the laboratory tests performed on them are necessary and covered by their insurance. Providers expect that they will be able to carry out what they believe to be the standard of care for their patients, and they furthermore expect that the systems in place from laboratories and payers will support their efforts without exposing their patients or their practice to financial toxicity. Payers, finally, desire to meet the needs of their customers, who are both patients as well as employers, by providing access to necessary healthcare services at a fair cost. Aligning these desires and perspectives is challenging in a fragmented healthcare system, and in the face of substantial opportunities for secondary gain from disreputable practices such as fraud, waste, and abuse.

Summary: Within the constraints of a US healthcare system based on competition and susceptible to misalignment, opportunities nonetheless exist for all relevant stakeholders in the laboratory testing space (patients, providers, and payers) to align and agree on practices that provide reasonably priced, fairly distributed, and medically necessary healthcare.

Background: Metagenomic next-generation sequencing (mNGS) for pathogen detection offers the potential for broad pathogen detection directly from clinical specimens. However, the yield and impact of testing is variable, financial cost is high, and questions surrounding its optimal use remain. Our pediatric institution used a clinical committee-based approach to discuss and approve or deny mNGS test requests. In this study, we evaluate the patient characteristics for which mNGS testing was considered, test yield, and clinical impact of mNGS results when employing this model of diagnostic stewardship.

Methods: Patients for which plasma cell-free DNA mNGS testing was requested and assessed by the clinical committee between August 1, 2018, and April 30, 2021, were included. The committee discussion emails were used to evaluate reasons for making the test request and treatment plans. Patient characteristics and additional clinical information were gathered by chart review. For approved cases, the clinical impact of the mNGS results were retrospectively adjudicated by infectious disease and clinical microbiology experts.

Results: Twelve requests for plasma cell-free DNA mNGS were evaluated and 9 were approved. mNGS results led to a positive clinical management change in 55% of approved requests. Negative clinical impact of mNGS testing did not occur during the study. The patients for which testing requests were denied had resolution of symptoms without further intervention.

Conclusions: This committee-based test request approval diagnostic stewardship model has the potential to support high-yield mNGS testing while using healthcare resources responsibly.

Background: Drug overdose-related deaths continue to increase globally. Testing demands have likewise increased, prompting healthcare facilities to adopt a range of methods, from simple point-of-care immunoassays to comprehensive chromatographic and mass spectrometry-based techniques. Each of these testing methods has trade-offs related to cost, performance, speed, and convenience, requiring healthcare facilities to carefully determine the best options to meet their clinical needs. Unfortunately, current testing practices may result in unnecessary costs and certain methods, such as immunoassays, have significant limitations that affect their clinical utility. As such, the goal of this review is to frame the current state of drug testing and related cost-effectiveness and patient centered approaches to address this evolving public health challenge.

Content: This review discusses the current state of substance use mortality/morbidity, the economic impact of substance use disorders, provides an overview of testing methods and their relative cost-benefit, solutions to improve test utilization and cost-effectiveness, and finally, future threats and new opportunities that can improve the clinical utility of these tests.

Summary: The cost-effectiveness of drugs of abuse testing revolves around proper test utilization, including understanding what test is being ordered, its limitations, understanding results, and ordering testing when it can provide actionable information. Fundamental principles of test utilization such as education, clinical informatics, and optimizing test panels remain essential. Future threats in this space include new compounds and regulatory changes. However, novel solutions such as new noninvasive sample types, automation, and artificial intelligence can play a significant role in improving overall test utilization practices.

Background: As clinical laboratories struggle to maintain their financial footing and as patients face mounting out-of-pocket expenses for diagnostic testing, being able to perform financial analysis of laboratory stewardship efforts has become an increasingly important skill.

Content: Understanding the revenue cycle as it relates to diagnostic testing is fundamental to selecting, designing, implementing, and evaluating laboratory stewardship interventions for maximum financial return. Leveraging the data and processes driving the revenue cycle can inform informatics-based interventions (such as clinical decision support) and allow deliberate financial analyses of stewardship-focused projects. For labs striving not only to ensure their own financial health but also to help their patients avoid financial toxicity, the most effective strategies often depend on developing productive partnerships with key players along the revenue cycle.

Summary: Financial laboratory analytics is an emerging skill set that can power laboratory stewardship efforts and whose benefits accrue to patients, clinicians, laboratories, and health systems.

Background: As healthcare identifies new opportunities to provide patient services and moves from volume to value payment models, the clinical laboratory is in an ideal position to serve as a catalyst for these changes. In 2017, the Project Santa Fe Foundation (PSFF) was founded to support the clinical laboratory's role to promote the objectives of population health and value-based healthcare. The initiative, known as Clinical Lab 2.0, uses longitudinal laboratory data to create actionable insights that can lead to improved patient and population outcomes, optimize the total cost of care, and reduce financial risk for stakeholders.

Content: The Clinical Lab 2.0 model was developed by a coalition of laboratory leaders to support clinical laboratories in the implementation of this new paradigm that moves beyond the provision of high-specificity and high-accuracy transactional test results and promotes "well care" and population health.To provide leadership for Clinical Lab 2.0 across healthcare, promote dissemination of these concepts to clinical laboratories, and create evidence of laboratory's value; the Foundation has several ongoing initiatives. The first initiative is the conduct of both single-site and multisite demonstration projects at PSFF member sites. The second ongoing initiative for the Foundation is the provision of guidance documents to support clinical laboratories in the implementation of Clinical Lab 2.0 and promote policy development. PSFF has developed 2 types of guidance document tools: Position Statements and Laboratory-Driven Care Models.

Summary: This review summarizes the history, background, and initiatives for Clinical Lab 2.0 supported by the Project Santa Fe Foundation.

Background: The use of laboratory resources has seen a substantial increase in recent years, driven by automation and emerging technologies. However, inappropriate use of laboratory testing, encompassing both overuse and underuse, poses significant challenges.

Content: This review explores the complex interplay between patient safety, economic, and environmental factors-known as the "triple bottom line" or "3Ps" for people, profit, and planet-associated with inappropriate use of laboratory resources. The first part of the review outlines the impact of inappropriate laboratory testing on patient safety and economic outcomes. Then the review examines the available literature on the environmental impact of laboratory activities. Several practical solutions for mitigating the environmental impact of laboratories are discussed. Finally, this review emphasizes how decreasing unnecessary laboratory testing results in cost savings and environmental benefits, as evidenced by interventional studies, without compromising patient safety.

Summary: The implementation of sustainable practices in laboratories can create a virtuous circle in which reduced testing enhances cost-efficiency, reduces the environmental footprint, and ensures patient safety, thereby benefiting the 3Ps. This review highlights the critical need for appropriate laboratory resource utilization in achieving sustainability in healthcare.

Background: In prolactinoma diagnosis, current guidelines recommend prolactin (PRL) assessment, considering values exceeding 200 ng/mL highly suggestive of prolactinoma. However, subtler hyperprolactinemia is more common, and to rule out potential prolactinomas, pituitary resonance magnetic imaging (MRI) studies are necessary. These present limitations in terms of availability, costs, and delays in diagnosis. We aimed to evaluate the screening utility of the metoclopramide (MCP) test in identifying patients with moderate hyperprolactinemia for whom MRI studies might be unnecessary.

Methods: We retrospectively selected patients with moderate hyperprolactinemia, with an MCP test and a pituitary MRI within the same assistance, and with no interfering pharmacological treatment. Increases in PRL (ΔPRLMax) and thyrotropin (ΔTSHMax) after MCP infusion were compared according to MRI findings: patients with microadenoma (<10 mm; n = 23), with macroadenoma (≥10 mm; n = 5), or without adenoma (n = 39).

Results: ΔPRLMax exceeds baseline PRL capability to identify patients with an adenoma (area under the curve = 0.872 vs 0.776). ΔPRLMax below 220% identifies 100% of these patients with 71% of specificity. This screening would have avoided 42% of MRI, resulting in a cost savings of 34%. Analysis of ΔTSHMax only slightly increased specificity when considered as a secondary criterion. Test duration can be shortened to 30 min without compromising its screening capability.

Conclusions: A short MCP test is a useful and cost-effective screening tool to avoid unnecessary MRI. Its simplicity allows its performance in almost any clinical facility to easily rule out prolactinoma in an important percentage of patients, something of upmost importance especially in regions where MRI facilities or their access are limited.

Background: Referral (send-out) laboratories support clinical needs but may cause issues for hospitals or health systems related to regulations and governance, specimen logistics, test result availability, and cost and reimbursement. The use of a "miscellaneous" referral test order can increase risks of specimen collection or processing errors, result delays, and repeat testing.

Methods: We established an approved referral laboratory test list and a digital form for providers to request new referral tests. We collated laboratory stewardship committee decisions over a 20-month period. Separately, we retrospectively reviewed referral tests ordered as miscellaneous across our health system over 1 year. Subject matter experts identified appropriate tests to build as discretely orderable in the electronic health record. Following targeted provider notification of the new tests, we assessed their uptake and impact on result turnaround times for the first 5 built tests over 6 months.

Results: Our laboratory stewardship committee approved 16 of 27 provider requests to build new referral tests over the first 20 months following implementation of the new request process. In addition, 37 of the 100 most frequently ordered miscellaneous tests were recommended to be built as discrete orders. Uptake of the first 5 built tests (relative to providers continuing to use miscellaneous orders) averaged 64% over the first 6 months. Result turnaround times improved by an average of 1.1 days when the discrete orders were used.

Conclusions: We successfully established oversight of referral laboratory testing across our health system, pivoted orders away from miscellaneous, and observed improvements in turnaround times.

Background: Diagnostic stewardship is a set of clinically based changes to the ordering, processing, and reporting of diagnostic tests designed to improve patient outcomes (through decreased inappropriate testing, and reduced patient harm from wrong, delayed, or missed diagnosis). It shares a common philosophy with laboratory stewardship but has some key differences.

Content: Laboratory stewardship focuses primarily on pre- and post-analytical components of the testing process. Laboratory stewardship encourages laboratorians to engage clinical partners in discussion around the impact of pre- and post-analytical components of testing. Diagnostic stewardship extends laboratory stewardship into clinical medicine as it considers the clinician's interaction and experience with the ordering system and attempts to modify clinical thinking, even before a test is ordered. Diagnostic stewardship then goes beyond the post-analytic laboratory interpretation of results to contextualize those results in evidence-based best practice recommendations. Compared to laboratory stewardship, diagnostic stewardship is clinician led vs laboratorian led, utilizes clinician-focused terminology rather than laboratory-specific language, and incorporates clinician decision support and behavioral economics to drive behavior change.

Summary: There are many complementary principles and activities between laboratory and diagnostic stewardship, and collaboration allows both programs to grow and improve patient overall quality of care.