CLINICS IN LABORATORY MEDICINE

Laboratory Informatics Approaches to Improving Care for Gender- Diverse Patients
Stoffel M, Luu HS and Krasowski MD
Improving care for gender-diverse (GD) patients necessitates developing informatics tools and approaches to support optimal laboratory testing. This requires increased functionality and standardization of laboratory information system/electronic health record and data collection processes. Data tailored to accommodate immediate clinical care and clinical decision support (CDS) also have an impact on interoperability and downstream data needs for patients. Informatics tools can shape the clinical care experience for GD patients by careful design of laboratory-patient interactions.
Racism in Drug Testing
Hubbard JA and Johnson-Davis KL
Racial disparities in drug testing for substance-use disorders underscore systemic inequalities. Studies reveal that minority groups, particularly Black and Hispanic Americans, are disproportionately targeted for drug testing despite similar rates of drug use across racial lines. Such bias impacts employment opportunities, legal outcomes, and access to treatment. The overrepresentation of minorities in drug testing reflects broader societal prejudices, leading to a cycle of discrimination and marginalization. Addressing these disparities requires a multifaceted approach, including policy reform, increased awareness of implicit biases, and equitable health care practices to ensure fair treatment of all individuals struggling with substance-use disorders.
Affirmative Healthcare for Transgender and Gender Nonconforming Patients: A Guide to Patient Assessment
Conlin SE, Pierre CC, Greene DN and Gill EL
This review article will discuss the impact of implicit and systematic bias on the health of transgender and gender nonconforming (TGNC) individuals and highlight barriers that TGNC people experience in accessing health care. The importance of affirmative care in improving the health of TGNC people will be described, followed by recommendations for gender inclusive practices that clinical laboratories can adopt to provide more inclusive care for TGNC people.
Literacy and Language Barriers to Overcome in Laboratory Medicine
Lazaro G, Dicent Taillepierre J and Richwine C
In the context of laboratory medicine, the authors describe 3 barriers to health communication: access, health communication, and language responsiveness. These barriers are interconnected and present in millions of people in need of equitable access to health communication. Equitable access entails health communication written in plain language and languages other than English to address language and literacy barriers and increase trust by avoiding language discordance and the spread of infodemics. This review includes several options to implement multidisciplinary efforts that lead to measurable improvements in health literacy.
Steps Forward to a Fair and Inclusive Blood Supply
Siu J, Katz L, Pagano MB and Hermelin D
Blood transfusions save lives. Scientific advancements in infectious disease testing, immunohematology, and blood processing, coupled with an altruistic blood donor model, blood transfusion has become a safe and effective therapeutic intervention. Blood establishments are an integral part of the health care continuum. However, challenges related to access to blood as well as diversity of blood donors can reflect the broader issues within our health care system. An awareness of the social injustices while using medical evidence-based data to support change will be essential for ensuring equitable access to life-saving treatments for all individuals and the communities we serve.
Promoting Health Equity Through Effective Laboratory Stewardship Strategies
Kroner GM, Katzman BM, Chambliss AB, Conta JH and Dickerson JA
There is a close relationship between the goals of laboratory stewardship and efforts to improve health equity for vulnerable populations. Laboratory stewardship programs should evaluate their policies and interventions to ensure that they improve access to testing, test selection, and result interpretation and delivery for all populations. Specific solutions to consider are (1) to evaluate the benefits of point-of-care testing when it can decrease barriers to specimen collection, (2) to use standardized naming conventions to help providers select the best test, and (3) to partner with insurance processing departments to help reduce financial barriers for expensive testing.
Access Barriers in Testing for Sexually Transmitted Infections across Gender and Sexual Identities
Khan A, Culbreath K, Goldstein Z and Greene DN
Sexually transmitted infections (STIs) are steadily increasing in incidence. Marginalized communities across social categories (race, ethnicity, gender, and sexuality) face the heaviest burden, including Black, indigenous, Latino, queer (gay, bisexual), transgender, and nonbinary populations. These disparities persist even when controlled for high-risk sexual behaviors. The laboratory maintains a responsibility to develop and offer appropriate testing for all communities. This review aims to integrate the clinical laboratory's role in building sexual health testing options across genders and sexual behaviors with a focus on molecular, swab-based testing.
History, Advances, and Challenges of Sickle Cell Disease Treatment
Walia R, Fertrin KY and Sabath DE
Sickle cell disease (SCD) is marked by red blood cells that deform into a sickle shape, causing severe health complications. Historic neglect and slow therapeutic progress have left many, especially African descendants, vulnerable. Recent treatment strides include novel drugs and gene therapy, promising improved management. Nonetheless, challenges persist with treatment adoption because of cost, adverse effects, and accessibility. Advancements hold hope for enhanced life quality and longevity for SCD patients.
A Winding Road to Health Care Equity in Sickle Cell Disease
Walia R, Fertrin KY and Sabath DE
Sickle cell disease (SCD) is a genetic disorder where red blood cells sickle, causing anemia and pain. Historically linked to marginalized groups, SCD saw little progress in treatment strategies for decades. Addressing these requires holistic strategies including dedicated centers, education, patient inclusion, and tackling implicit bias. Efforts must ensure treatments are accessible and stigma-free. Progress depends on collaboration and advocacy, aiming for an equitable, patient-focused health care system responsive to the unique needs of those with SCD. This review illustrates the actionable steps that the medical community can take to improve care for patients with SCD.
Influence of Race Modifiers in Estimated Glomerular Filtration Rate Calculations on Medication Dosing, Access, and Transplant Eligibility
Price EL and Cotten SW
The 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation for estimation of glomerular filtration rate (GFR) lower values for Black individuals relative to previous equations, which may change medication eligibility or trigger the need to reevaluate dosing decisions. Major drug classes such as antibiotics, antidiabetic medications, cardiovascular agents, medications for the treatment of psychiatric illness, and chemotherapy drugs all have estimated GFR thresholds for prescribing eligibility. However, the use of strict thresholds for medication eligibility should be heavily scrutinized, and individualized comprehensive approaches should be used for patients on the cusps of these thresholds.
Inclusive Laboratory Reference Intervals and Clinical Studies to Reduce Health Disparities
Rytz CL and Ahmed SB
Health inequities are common and in part a consequence of non-inclusive health research. The underrepresentation of specific populations in research, including women, children, youth and the elderly, racialized and ethnic groups, and sexual and gender minorities, results in limited ability to develop appropriate reference intervals, determine effective treatments, and establish health guidelines to optimize health outcomes for all. By working together toward greater inclusivity in all aspects of health research and care, health care providers and professional medical societies, including laboratory medicine practitioners, have the ability to achieve health equity.
Contextualizing Race and Ethnicity in the Practice of Laboratory Medicine
Pierre CC
Race and ethnicity are population descriptors that clinicians and researchers often use to classify humans. The utility of these groupings in research and clinical contexts warrants scrutiny, since these groupings fail to adequately capture genetic diversity and instead, are proxies for the complex interplay of genetic, social, and structural determinants of health. Here, the authors review the concepts of race, ethnicity, and genetics. They also describe laboratory medicine examples where race and ethnicity are used that warrant scrutiny and revision, and areas where greater emphasis on including racialized minorities is necessary to improve health disparities.
Addressing Health Disparities in Clinical Pathology and Laboratory Medicine
Greene DN
Flow Cytometric Assessment of Malignant Hematologic Disorders
Hartzell CM, Shaver AC and Mason EF
Multiparameter flow cytometry (MPF) is an essential component of the diagnostic workup of hematologic malignancies. Recently developed tools have expanded the utility of MPF in detecting T-cell clonality and myelomonocytic dysplasia. Minimal/measurable residual disease analysis has long been established as critical in the management of B-lymphoblastic leukemia and is emerging as a useful tool in myeloid malignancies. With the continued increased complexity of MPF assays, emerging tools for data collection and analysis will allow users to take full advantage of MPF in the diagnosis of hematologic disease.
Applications of Flow Cytometry in Diagnosis and Evaluation of Red Blood Cell Disorders
Dadelahi A, Jackson T, Agarwal AM, Lin L, Rets AV and Ng DP
Clinical flow cytometry plays a vital role in the diagnosis and monitoring of various red blood cell disorders. The high throughput, precision, and automation potential of this technique allows for cost-effective and timely analysis compared to older and more manual test methods. Flow cytometric analysis serves as the gold standard diagnostic method for multiple hematological disorders, especially in clinical scenarios where an assay needs to have high sensitivity, high specificity, and a short turnaround time. In this review, we discuss the role of flow cytometric analysis in paroxysmal nocturnal hemoglobinuria, fetal-maternal hemorrhage, and hereditary spherocytosis.
Flow Cytometry-based Immune Phenotyping of T and B Lymphocytes in the Evaluation of Immunodeficiency and Immune Dysregulation
Nguyen AA and Platt CD
There are approximately 500 congenital disorders that impair immune cell development and/or function. Patients with these disorders may present with a wide range of symptoms, including increased susceptibility to infection, autoimmunity, autoinflammation, lymphoproliferation, and/or atopy. Flow cytometry-based immune phenotyping of T and B lymphocytes plays an essential role in the evaluation of patients with these presentations. In this review, we describe the clinical utility of flow cytometry as part of a comprehensive evaluation of immune function and how this testing may be used as a diagnostic tool to identify underlying aberrant immune pathways, monitor disease activity, and assess infection risk.
Flow Cytometry and Platelets
Frelinger AL
Clinical assessment of platelet activation by flow cytometry is useful in the characterization and diagnosis of platelet-specific disorders and as a measure of risk for thrombosis or bleeding. Platelets circulate in a resting, "unactivated" state, but when activated they undergo alterations in surface glycoprotein function and/or expression level, exposure of granule membrane proteins, and exposure of procoagulant phospholipids. Flow cytometry provides the means to detect these changes and, unlike other platelet tests, is appropriate for measuring platelet function in samples from patients with low platelet counts. The present review will focus on flow cytometric tests for platelet activation markers.
Routine Coagulation
Favaloro EJ and Pasalic L
The term 'routine coagulation' typically applies to hemostasis tests routinely performed in hematology laboratories, often available 24/7, and potentially ordered urgently. These tests would comprise of the prothrombin time (PT), the PT converted to an international normalized ratio, the activated partial thromboplastin time (often called partial thromboplastin time in North American laboratories) and potentially the thrombin time, the D-dimer assay, and fibrinogen assays. Although other tests could feasibly be offered (testing feasible), there are good reasons for not including all of these other tests in all routine coagulation laboratories.
Heparin Induced Thrombocytopenia Testing
Dees DC
This article provides a comprehensive overview of Heparin-Induced Thrombocytopenia (HIT) with an emphasis on laboratory testing and advantages of automation. HIT is a critical condition arising from heparin exposure, leading to a contradictory combination of thrombocytopenia with an increased thrombosis risk. The article discusses HIT's history, clinical presentation, laboratory diagnosis, and management strategies. It highlights the importance of interdisciplinary collaboration for effective diagnosis and treatment, underscoring advancements in technology and targeted therapies that are shaping future approaches to HIT management.
Assessing Direct Oral Anticoagulants in the Clinical Laboratory
Gosselin RC and Cuker A
Direct oral anticoagulants (DOACs) have significant advantages over vitamin K antagonists including lack of need for routine laboratory monitoring. However, assessment of DOAC effect and concentration may be important to guide clinical management including need for DOAC reversal, particularly in acute or emergent situations. In this manuscript, the authors describe tests to screen for DOAC presence and tests that have demonstrated equivalence to gold standard testing for quantifying DOAC exposure. They also discuss the effect of DOACs on other coagulation assays and strategies for monitoring unfractionated heparin in patients with concomitant DOAC exposure.
Hematology Laboratory in the Digital and Automation Age
Pozdnyakova O and Brugnara C