Laboratory Test Names Matter: A Survey on What Works and What Doesn't Work for Orders and Results.

CONTEXT.­: Health care providers were surveyed to determine their ability to correctly decipher laboratory test names and their preferences for laboratory test names and result displays. OBJECTIVE.­: To confirm principles for laboratory test nomenclature and display and to compare and contrast the abilities and preferences of different provider groups for laboratory test names. DESIGN.­: Health care providers across different specialties and perspectives completed a survey of 38 questions, which included participant demographics, real-life examples of poorly named laboratory orders that they were asked to decipher, an assessment of vitamin D test name knowledge, their preferences for ideal names for tests, and their preferred display for test results. Participants were grouped and compared by profession, level of training, and the presence or absence of specialization in informatics and/or laboratory medicine. RESULTS.­: Participants struggled with poorly named tests, especially with less commonly ordered tests. Participants' knowledge of vitamin D analyte names was poor and consistent with prior published studies. The most commonly selected ideal names correlated positively with the percentage of the authors' previously developed naming rules (R = 0.54, P < .001). There was strong consensus across groups for the best result display. CONCLUSIONS.­: Poorly named laboratory tests are a significant source of provider confusion, and tests that are named according to the authors' naming rules as outlined in this article have the potential to improve test ordering and correct interpretation of results. Consensus among provider groups indicates that a single yet clear naming strategy for laboratory tests is achievable.

Interpersonal Connections Are Important for Virtual Kidney Transplant Educational Program Development.

Introduction: The Living Donor Navigator program is designed to mitigate disparities in living donor kidney transplantation, although geographic disparities in program participation were observed in the initial years of implementation. The purpose of this study was to understand participant perspectives regarding the use of a virtual option/alternative to expand program participation. Methods: Previous participants of the in-person navigator program were purposively sampled. Using the nominal group technique, a well-structured formative methodology to elicit participant perspectives, 2 meetings were conducted among transplant recipients and advocates (N = 13) to identify and prioritize responses to the question "What things would concern you about participating in a virtual and remote Living Donor Navigator program?" Findings: Mean participant age was 59.3 (9.3) years, and participants were 54% male and 62% white. Education levels varied from less than high school to master's degrees. Participants generated 70 unique responses, of which 36 (51.4%) received prioritization. The top 5 ranked responses of each nominal group technique meeting received approximately 50 percent (47.6% vs. 66.7%, respectively) of the total votes and described the potentially limited interpersonal connections, time conflicts, and differing content in a virtual navigator program compared to the in-person model. Discussion: These data suggest that previous participants were concerned with upholding the original design of the program, thus, virtual living donor kidney transplantation programs should aim to maintain interpersonal connections and consistency of content to ensure adequate programmatic engagement. Future research will focus on program fidelity independent of delivery modality.

Proceedings of the Association for Pathology Informatics Bootcamp 2022.

The Pathology Informatics Bootcamp, held annually at the Pathology Informatics Summit, provides pathology trainees with essential knowledge in the rapidly evolving field of Pathology Informatics. With a focus on data analytics, data science, and data management in 2022, the bootcamp addressed the growing importance of data analysis in pathology and laboratory medicine practice. The expansion of data-related subjects in Pathology Informatics Essentials for Residents (PIER) and the Clinical Informatics fellowship examinations highlights the increasing significance of these skills in pathology practice in particular and medicine in general. The curriculum included lectures on databases, programming, analytics, machine learning basics, and specialized topics like anatomic pathology data analysis and dashboarding.

Influence of user-centered clinical decision support on pediatric blood product ordering errors.

BACKGROUND: Children are at increased risk from transfusion-related medical errors. Clinical decision support (CDS) can enhance pediatric providers' decision-making regarding transfusion practices including indications, volume, rate, and special processing instructions. Our objective was to use CDS in a pediatric health system to reduce:blood product-related safety events from ordering errors;special processing ordering errors for patients with T-cell dysfunction, sickle cell disease (SCD), or thalassemia;transfusions administered faster than 5 mL/kg/h. MATERIALS AND METHODS: In this single-center before and after quality improvement study, we evaluated how user-centered design of pediatric blood product orders influenced pediatric transfusion practices and outcomes. Safety events were identified through active and passive surveillance. Other clinically relevant outcomes were identified through electronic health record queries. RESULTS: Blood product-related safety events from ordering errors did not change significantly from the baseline period (6 events, 0.4 per month, from 1/1/2018-3/27/2019) to the intervention period (1 event, 0.1 per month, from 3/28/2019-12/31/2019; rate ratio: 0.27 [0.01-2.25]). Packed red blood cell (PRBC) and platelet orders for patients with T-cell dysfunction that did not specify irradiation decreased significantly from 488/12,359 (3.9%) to 204/6,711 (3.0%, risk ratio: 0.77 [0.66-0.90]). PRBC orders for patients with SCD or thalassemia that did not specify phenotypically similar units fell from 386/2,876 (13.4%) to 57/1,755 (3.2%, risk ratio: 0.24 [0.18-0.32]). Transfusions administered faster than 5 mL/kg/h decreased from 4,112/14,641 (28.1%) to 2,125/9,263 (22.9%, risk ratio: 0.82 [0.78-0.85]). DISCUSSION: User-centered design of CDS for pediatric blood product orders significantly reduced special processing ordering errors and inappropriate transfusion rates. Larger studies are needed to evaluate the impact on safety events.

Greater community vulnerability is associated with poor living donor navigator program fidelity.

BACKGROUND: Community-level factors contribute to living donor kidney transplantation disparities but may also influence the interventions aimed to mitigate these disparities. The Living Donor Navigator Program was designed to separate the advocacy role from the patient in need of transplantation-friends/family are encouraged to participate as the patients' advocates to identify living donors, though some of the patients participate alone as self-advocates. Self-advocates have a lower living donor kidney transplantation likelihood compared to the patients with an advocate. We sought to evaluate the relationship between the patients' community-level vulnerability and living donor navigator self-advocacy as a surrogate for program fidelity. METHODS: This single-center, retrospective study included 110 Living Donor Navigator participants (April 2017-June 2019). Program fidelity was assessed using the participants' advocacy status. Measures of community vulnerability were obtained from the Centers for Disease Control and Prevention Social Vulnerability Index. Modified Poisson regression was used to evaluate the association between community-level vulnerability and living donor navigator self-advocacy. RESULTS: Of the 110 participants, 19% (n = 21) were self-advocates. For every 10% increase in community-level vulnerability, patients had 17% higher risk of self-advocacy (adjusted relative risk 1.17, 95% confidence interval: 1.03-1.32, P = .01). Living in areas with greater unemployment (adjusted relative risk: 1.18, 95% confidence interval: 1.04-1.33, P = .01), single-parent households (adjusted relative risk: 1.23, 95% confidence interval: 1.06-1.42, P = .006), minority population (adjusted relative risk: 1.30, 95% confidence interval: 1.04-1.55, P = .02), or no-vehicle households (adjusted relative risk: 1.17, 95% confidence interval: 1.02-1.35, P = .02) were associated with increased risk of self-advocacy. CONCLUSION: Having a greater community-level vulnerability was associated with poor Living Donor Navigator Program fidelity. The potential barriers identified using the Social Vulnerability Index may direct resource allocation and program refinement to optimize program fidelity and efficacy for all participants.

Comprehensive Genomic Profiling of High-Risk Pediatric Cancer Patients Has a Measurable Impact on Clinical Care.

PURPOSE: Profiling of pediatric cancers through deep sequencing of large gene panels and whole exomes is rapidly being adopted in many clinical settings. However, the most impactful approach to genomic profiling of pediatric cancers remains to be defined. METHODS: We conducted a prospective precision medicine trial, using whole-exome sequencing of tumor and germline tissue and whole-transcriptome sequencing (RNA Seq) of tumor tissue to characterize the mutational landscape of 127 tumors from 126 unique patients across the spectrum of pediatric brain tumors, hematologic malignancies, and extracranial solid tumors. RESULTS: We identified somatic tumor alterations in 121/127 (95.3%) tumor samples and identified cancer predisposition syndromes on the basis of known pathogenic or likely pathogenic germline mutations in cancer predisposition genes in 9/126 patients (7.1%). Additionally, we developed a novel scoring system for measuring the impact of tumor and germline sequencing, encompassing therapeutically relevant genomic alterations, cancer-related germline findings, recommendations for treatment, and refinement of risk stratification or prognosis. At least one impactful finding from the genomic results was identified in 108/127 (85%) samples sequenced. A recommendation to consider a targeted agent was provided for 82/126 (65.1%) patients. Twenty patients ultimately received therapy with a molecularly targeted agent, representing 24% of those who received a targeted agent recommendation and 16% of the total cohort. CONCLUSION: Paired tumor/normal whole-exome sequencing and tumor RNA Seq of de novo or relapsed/refractory tumors was feasible and clinically impactful in high-risk pediatric cancer patients.

Lessons Learned from OpenNotes Learning Mode and Subsequent Implementation across a Pediatric Health System.

BACKGROUND: The 21st Century Cures Act has accelerated adoption of OpenNotes, providing new opportunities for patient and family engagement in their care. However, these regulations present new challenges, particularly for pediatric health systems aiming to improve information sharing while minimizing risks associated with adolescent confidentiality and safety. OBJECTIVE: Describe lessons learned preparing for OpenNotes across a pediatric health system during a 4-month trial period (referred to as "Learning Mode") in which clinical notes were not shared by default but decision support was present describing the upcoming change and physicians could request feedback on complex cases from a multidisciplinary team. METHODS: During Learning Mode (December 3, 2020-March 9, 2021), implementation included (1) educational text at the top of commonly used note types indicating that notes would soon be shared and providing guidance, (2) a new confidential note type, and (3) a mechanism for physicians to elicit feedback from a multidisciplinary OpenNotes working group for complex cases with questions related to OpenNotes. The working group reviewed lessons learned from this period, as well as implementation of OpenNotes from March 10, 2021 to June 30, 2021. RESULTS: During Learning Mode, 779 confidential notes were written across the system. The working group provided feedback on 14 complex cases and also reviewed 7 randomly selected confidential notes. The proportion of physician notes shared with patients increased from 1.3% to 88.4% after default sharing of notes to the patient portal. Key lessons learned included (1) sensitive information was often present in autopopulated elements, differential diagnoses, and supervising physician note attestations; and (2) incorrect reasons were often selected by clinicians for withholding notes but this accuracy improved with new designs. CONCLUSION: While OpenNotes provides an unprecedented opportunity to engage pediatric patients and their families, targeted education and electronic health record designs are needed to mitigate potential harms of inappropriate disclosures.

Electronic Health Records and Genomics: Perspectives from the Association for Molecular Pathology Electronic Health Record (EHR) Interoperability for Clinical Genomics Data Working Group.

The use of genomics in medicine is expanding rapidly, but information systems are lagging in their ability to support genomic workflows both from the laboratory and patient-facing provider perspective. The complexity of genomic data, the lack of needed data standards, and lack of genomic fluency and functionality as well as several other factors have contributed to the gaps between genomic data generation, interoperability, and utilization. These gaps are posing significant challenges to laboratory and pathology professionals, clinicians, and patients in the ability to generate, communicate, consume, and use genomic test results. The Association for Molecular Pathology Electronic Health Record Working Group was convened to assess the challenges and opportunities and to recommend solutions on ways to resolve current problems associated with the display and use of genomic data in electronic health records.

Impact of Social Vulnerability on Access to Educational Programming Designed to Enhance Living Donation.

INTRODUCTION: Transplant candidate participation in the Living Donor Navigator Program is associated with an increased likelihood of achieving living donor kidney transplantation; yet not every transplant candidate participates in navigator programming. RESEARCH QUESTION: We sought to assess interest and ability to participate in the Living Donor Navigator Program by the degree of social vulnerability. DESIGN: Eighty-two adult kidney-only candidates initiating evaluation at our center provided Likert-scaled responses to survey questions on interest and ability to participate in the Living Donor Navigator Program. Surveys were linked at the participant-level to the Centers for Disease Control and Prevention Social Vulnerability Index and county health rankings and overall social vulnerability and subthemes, individual barriers, telehealth capabilities/ knowledge, interest, and ability to participate were assessed utilizing nonparametric Wilcoxon ranks sums tests, chi-square, and Fisher's exact tests. RESULTS: Participants indicating distance as a barrier to participation in navigator programming lived approximately 82 miles farther from our center. Disinterested participants lived in areas with the highest social vulnerability, higher physical inactivity rates, lower college education rates, and higher uninsurance (lack of insurance) and unemployment rates. Similarly, participants without a computer, who never heard of telehealth, and who were not encouraged to participate in telehealth resided in areas of highest social vulnerability. CONCLUSION: These data suggest geography combined with being from under-resourced areas with high social vulnerability was negatively associated with health care engagement. Geography and poverty may be surrogates for lower health literacy and fewer health care interactions.

Evaluation of Community-Level Vulnerability and Racial Disparities in Living Donor Kidney Transplant.

Importance: Living donor kidney transplant (LDKT) is the ideal treatment for end-stage kidney disease, but racial disparities in LDKT have increased over the last 2 decades. Recipient clinical and social factors do not account for LDKT racial inequities, although comprehensive measures of community-level vulnerability have not been assessed. Objective: To determine if racial disparities persist in LDKT independent of community-level vulnerability. Design, Setting, and Participants: This retrospective, multicenter, cross-sectional study included data from 19 287 adult kidney-only transplant recipients in the Scientific Registry of Transplant Recipients. The study included individuals who underwent transplant between January 1 and December 31, 2018. Exposures: Recipient race and the 2018 US Centers for Disease Control and Prevention Social Vulnerability Index (SVI). Census tract-level SVI data were linked to census tracts within each recipient zip code. The median SVI measure among the census tracts within a zip code was used to describe community-level vulnerability. Main Outcomes and Measures: Kidney transplant donor type (deceased vs living). Modified Poisson regression was used to evaluate the association between SVI and LDKT, and to estimate LDKT likelihood among races, independent of community-level vulnerability and recipient-level characteristics. Results: Among 19 287 kidney transplant recipients, 6080 (32%) received LDKT. A total of 11 582 (60%) were male, and the median (interquartile range) age was 54 (43-63) years. There were 760 Black LDKT recipients (13%), 4865 White LDKT recipients (80%), and 455 LDKT recipients of other races (7%; American Indian, Asian, multiracial, and Pacific Islander). Recipients who lived in communities with higher SVI (ie, more vulnerable) had lower likelihood of LDKT compared with recipients who lived in communities with lower SVI (ie, less vulnerable) (adjusted relative risk [aRR], 0.97; 95% CI, 0.96-0.98; P < .001). Independent of community-level vulnerability, compared with White recipients, Black recipients had 37% lower likelihood (aRR, 0.63; 95% CI, 0.59-0.67; P < .001) and recipients of other races had 24% lower likelihood (aRR, 0.76; 95% CI, 0.70-0.82; P < .001) of LDKT. The interaction between SVI and race was significant among Black recipients, such that the disparity in LDKT between Black and White recipients increased with greater community-level vulnerability (ratio of aRRs, 0.67; 95% CI, 0.51-0.87; P = .003). Conclusions and Relevance: Community-level vulnerability is associated with access to LDKT but only partially explains LDKT racial disparities. The adverse effects of living in more vulnerable communities were worse for Black recipients. The interaction of these constructs is worrisome and suggests evaluation of other health system factors that may contribute to LDKT racial disparities is needed.

Self-advocacy is associated with lower likelihood of living donor kidney transplantation.

BACKGROUND: The Living Donor Navigator (LDN) Program pairs kidney transplant candidates (TC) with a friend or family member for advocacy training to help identify donors and achieve living donor kidney transplantation (LDKT). However, some TCs participate alone as self-advocates. METHODS: In this retrospective cohort study of TCs in the LDN program (04/2017-06/2019), we evaluated the likelihood of LDKT using Cox proportional hazards regression and rate of donor screenings using ordered events conditional models by advocate type. RESULTS: Self-advocates (25/127) had lower likelihood of LDKT compared to patients with an advocate (adjusted hazard ratio (aHR): 0.22, 95% confidence interval (CI): 0.03-1.66, p = 0.14). After LDN enrollment, rate of donor screenings increased 2.5-fold for self-advocates (aHR: 2.48, 95%CI: 1.26-4.90, p = 0.009) and 3.4-fold for TCs with an advocate (aHR: 3.39, 95%CI: 2.20-5.24, p < 0.0001). CONCLUSIONS: Advocacy training was beneficial for self-advocates, but having an independent advocate may increase the likelihood of LDKT.

Enhanced Advocacy and Health Systems Training Through Patient Navigation Increases Access to Living-donor Kidney Transplantation.

BACKGROUND: To date, no living donation program has simultaneously addressed the needs of both transplant candidates and living donors by separating the advocacy role from the candidate and improving potential donor comfort with the evaluation process. We hypothesized that the development of a novel program designed to promote both advocacy and systems training among transplant candidates and their potential living kidney donors would result in sustained increases in living-donor kidney transplantation (LDKT). To this end, we developed and implemented a Living Donor Navigator (LDN) Program at the University of Alabama at Birmingham. METHODS: We included adult patients awaiting kidney-only transplant in a retrospective cohort analysis. Using time-varying Cox proportional hazards regression, we explored likelihood of living donor screening and approval by participation in the LDN program. RESULTS: There were 56 LDN participants and 1948 nonparticipants (standard of care). LDN was associated with a 9-fold increased likelihood of living donor screenings (adjusted hazard ratio, 9.27; 95% confidence interval, 5.97-14.41, P < 0.001) and a 7-fold increased likelihood of having an approved living donor (adjusted hazard ratio, 7.74; 95% confidence interval, 3.54-16.93; P < 0.001) compared with the standard of care. Analyses by participant race demonstrated higher likelihood of screened donors and a similar likelihood of having an approved donor among African Americans compared with Caucasians. CONCLUSIONS: These data suggest that both advocacy and systems training are needed to increase actual LDKT rates, and that LDN programs may mitigate existing racial disparities in access to LDKT.

A Survey of LOINC Code Selection Practices Among Participants of the College of American Pathologists Coagulation (CGL) and Cardiac Markers (CRT) Proficiency Testing Programs.

CONTEXT.­: Biomedical terminologies such as Logical Observation Identifiers, Names, and Codes (LOINC) were developed to enable interoperability of health care data between disparate health information systems to improve patient outcomes, public health, and research activities. OBJECTIVE.­: To ascertain the utilization rate and accuracy of LOINC terminology mapping to 10 commonly ordered tests by participants of the College of American Pathologists (CAP) Proficiency Testing program. DESIGN.­: Questionnaires were sent to 1916 US and Canadian laboratories participating in the 2018 CAP coagulation (CGL) and/or cardiac markers (CRT) surveys requesting information on practice setting, instrument(s) and test method(s), and LOINC code selection and usage in the laboratory and electronic health records. RESULTS.­: Ninety of 1916 CGL and/or CRT participants (4.7%) responded to the questionnaire. Of the 275 LOINC codes reported, 54 (19.6%) were incorrect: 2 codes (5934-2 and 12345-1) (0.7%) did not exist in the LOINC database and the highest error rates were observed in the property (27 of 275, 9.8%), system (27 of 275, 9.8%), and component (22 of 275, 8.0%) LOINC axes. Errors in LOINC code selection included selection of the incorrect component (eg, activated clotting time instead of activated partial thromboplastin time); selection of panels that can never be used to obtain an individual analyte (eg, prothrombin time panel instead of international normalized ratio); and selection of an incorrect specimen type. CONCLUSIONS.­: These findings of real-world LOINC code implementation across a spectrum of laboratory settings should raise concern about the reliability and utility of using LOINC for clinical research or to aggregate data.

Formative Usability Testing Reduces Severe Blood Product Ordering Errors.

BACKGROUND: Medical errors in blood product orders and administration are common, especially for pediatric patients. A failure modes and effects analysis in our health care system indicated high risk from the electronic blood ordering process. OBJECTIVES: There are two objectives of this study as follows:(1) To describe differences in the design of the original blood product orders and order sets in the system (original design), new orders and order sets designed by expert committee (DEC), and a third-version developed through user-centered design (UCD).(2) To compare the number and type of ordering errors, task completion rates, time on task, and user preferences between the original design and that developed via UCD. METHODS: A multidisciplinary expert committee proposed adjustments to existing blood product order sets resulting in the DEC order set. When that order set was tested with front-line users, persistent failure modes were detected, so orders and order sets were redesigned again via formative usability testing. Front-line users in their native clinical workspaces were observed ordering blood in realistic simulated scenarios using a think-aloud protocol. Iterative adjustments were made between participants. In summative testing, participants were randomized to use the original design or UCD for five simulated scenarios. We evaluated differences in ordering errors, time on task, and users' design preference with two-sample t-tests. RESULTS: Formative usability testing with 27 providers from seven specialties led to 18 changes made to the DEC to produce the UCD. In summative testing, error-free task completion for the original design was 36%, which increased to 66% in UCD (30%, 95% confidence interval [CI]: 3.9-57%; p = 0.03). Time on task did not vary significantly. CONCLUSION: UCD led to substantially different blood product orders and order sets than DEC. Users made fewer errors when ordering blood products for pediatric patients in simulated scenarios when using the UCD orders and order sets compared with the original design.

Donation approval among obese living kidney donor candidates: The impact of metabolic syndrome.

BACKGROUND: The scarcity of organs available for transplantation has increased attempts to augment transplantation by utilizing obese living kidney donors. The literature has suggested that these donors have increased risks postdonation. Not surprising, the threshold for living kidney donor approval among obese persons is typically higher and the process more costly. Therefore, a screening tool to predict the likelihood of approval among obese living kidney donor candidates was created. METHODS: A single-center retrospective study was performed among obese (body mass index ≥ 30 kg/m2) living kidney donor candidates evaluated in clinic (January 1, 2012, to December 31, 2017). Approved candidates were compared with those not approved using multivariable logistic regression, and a prediction tool was generated. RESULTS: Among 389 obese living kidney donor candidates, there were no significant differences in sex or race and ethnicity by approval status. However, nonapproved candidates had a higher prevalence of metabolic syndrome. In the prediction model, glucose impairment and hypertension were most predictive of nonapproval. CONCLUSION: Among obese living kidney donor candidates, several metabolic syndrome components were associated with decreased odds of approval. This tool may serve as a useful initial screening for obese living kidney donor candidates, permitting more cost-effective evaluation processes. The tool could also be used to promote expeditious interventions in the preclinical setting, including weight management programs, to improve the likelihood of donation and postdonation outcomes.

Patient Perspectives on Weight Management for Living Kidney Donation.

BACKGROUND: Living kidney donors (LKDs) with obesity have increased perioperative risks and risk of end-stage renal disease after donation. Consequently, obesity serves as a barrier to donation, as many transplant centers encourage or require weight loss before donation for obese LKD candidates. Therefore, this study sought to assess patients' perspectives on weight management strategies before donation among obese LKD candidates. We hypothesized that willingness to participate in a weight loss program may be associated with donor-recipient relationship. MATERIALS AND METHODS: Obese (BMI ≥30 kg/m2) LKD candidates evaluated at a single institution from September 2017 to August 2018 were recruited. A survey was administered to assess LKD candidates' baseline exercise and dietary habits and their interest in weight management strategies for the purpose of donation approval. Participants were grouped by relationship to the recipient (close relatives: first-degree relatives or spouses [n = 29], compared with all other relationships [n = 21]). Descriptive statistics were used to summarize the data. RESULTS: 50 of 51 obese LKD candidates who were approached completed the survey. 90% of participants expressed willingness to lose weight if necessary to become eligible for donor nephrectomy. Compared with all other LKD candidates, close relatives were more likely to be interested in combined diet and exercise programs at our institution (P = 0.01). CONCLUSIONS: Among obese LKD candidates, there was an interest in weight loss for the purposes of living kidney donation approval, particularly among close relatives of potential recipients. Future programs designed to promote weight management efforts for obese LKD candidates should be considered.

Expanding the Scope of The Journal of Molecular Diagnostics to the Informatics Subdivision of the Association for Molecular Pathology.

This editorial describes the expanded scope of The Journal of Molecular Diagnostics, to include informatics-based articles.