Optimizing Identification of Allergic Sensitization to Seasonal Inhalant Allergens in the USA: Implications for Constructing Optimal Panels to Evaluate Patients with Allergy.

INTRODUCTION: While a specific number and type of antigens are recognized to detect perennial inhalant allergies, the optimal number and combination of allergens to reliably identify seasonal allergic sensitization is unclear due to limited national data. This study analyzed aeroallergen testing data from a large US clinical reference laboratory to provide guidance for optimizing seasonal allergen test selection. METHODS: The 2019 serum IgE tests for seasonal inhalant allergens were identified from the Quest Diagnostics database. Patients with results for at least 1 of 31 seasonal allergens across 4 allergen classes (11 trees, 7 weeds, 5 grasses, and 8 molds) were analyzed. A step-by-step conditional approach was employed to determine the minimum number and species of allergens needed to identify at least 98% of sensitized patients for each class. RESULTS: Of 88,042 patients tested for ≥1 seasonal allergen, 1.5%, 1.8%, 1.3%, and 1.6% were tested for all trees, weeds, grasses, and molds, respectively. Of those tested for all allergens within a class, 40.4%, 38.6%, 29.5%, and 21.2% were sensitized to at least one tree, weed, grass, or mold allergen, respectively. Identification of ≥98% of sensitized patients within a class required 8 allergens for trees (mountain cedar, maple box elder, walnut, white ash, elm, birch, cottonwood, and hickory/pecan), 5 for weeds (common ragweed short, rough pigweed, English plantain, lamb's quarters/goosefoot, and Russian thistle), 3 for grasses (June/Kentucky blue grass, Johnson grass, and Bermuda grass), and 7 for molds (Alternaria alternata, Aspergillus fumigatus, Mucor racemosus, Epicoccum purpurascens, Penicillium notatum, Helminthosporium halodes, and Fusarium moniliforme). CONCLUSION: A minimum of 23 antigens is required to optimally detect sensitization to four classes of seasonal allergens (i.e., ≥98% identification). The addition of these allergens to unique perennial allergens (cat, dog, mouse, cockroach, and 2 dust mite species) results in a comprehensive elucidation of inhalant allergen sensitization. This knowledge provides a pivotal guide for clinical laboratories as they construct allergen panels to optimize diagnostic yield.

National Kidney Foundation Laboratory Engagement Working Group Recommendations for Implementing the CKD-EPI 2021 Race-Free Equations for Estimated Glomerular Filtration Rate: Practical Guidance for Clinical Laboratories.

Recognizing that race is a social and not a biological construct, healthcare professionals and the public have called for removal of race in clinical algorithms. In response, the National Kidney Foundation and the American Society of Nephrology created the Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases to examine the issue and provide recommendations. The final report from the Task Force recommends calculating estimated glomerular filtration rate (eGFR) without a race coefficient using the recently published CKD-EPI 2021 creatinine (cr) and creatinine-cystatin C (cr-cys) equations. The Task Force recommends immediately replacing older eGFRcr equations (MDRD Study and CKD-EPI 2009) with the new CKD-EPI 2021 equation. In a 2019 survey by the College of American Pathologists, 23% of 6200 laboratories reporting eGFRcr used an incorrect equation that is not suitable for use with standardized creatinine measurements, 34% used the CKD-EPI 2009 equation and 43% used the MDRD Study 2006 equation re-expressed for standardized creatinine measurement. Rapid transition to using the CKD-EPI 2021 equation is an opportunity for laboratories to standardize to a single equation to eliminate differences in eGFRcr due to different equations used by different laboratories, and to report eGFR without use of race. We provide guidance to laboratories for implementing the CKD-EPI 2021 equations for both eGFRcr and eGFRcr-cys.

Electronic health record interventions at the point of care improve documentation of care processes and decrease orders for genetic tests commonly ordered by nongeneticists.

OBJECTIVE: To determine whether electronic health record (EHR) tools improve documentation of pre- and postanalytic care processes for genetic tests ordered by nongeneticists. METHODS: We conducted a nonrandomized, controlled, pre-/postintervention study of EHR point-of-care tools (informational messages and template report) for three genetic tests. Chart review assessed documentation of genetic testing processes of care, with points assigned for each documented item. Multiple linear and logistic regressions assessed factors associated with documentation. RESULTS: Preimplementation, there were no significant site differences (P > 0.05). Postimplementation, mean documentation scores increased (5.9 (2.1) vs. 5.0 (2.2); P = 0.0001) and records with clinically meaningful documentation increased (score >5: 59 vs. 47%; P = 0.02) at the intervention versus the control site. Pre- and postimplementation, a score >5 was positively associated with abnormal test results (OR = 4.0; 95% CI: 1.8-9.2) and trainee provider (OR = 2.3; 95% CI: 1.2-4.6). Postimplementation, a score >5 was also positively associated with intervention site (OR = 2.3; 95% CI: 1.1-5.1) and specialty clinic (OR = 2.0; 95% CI: 1.1-3.6). There were also significantly fewer tests ordered after implementation (264/100,000 vs. 204/100,000; P = 0.03), with no significant change at the control site (280/100,000 vs. 257/100,000; P = 0.50). CONCLUSIONS: EHR point-of-care tools improved documentation of genetic testing processes and decreased utilization of genetic tests commonly ordered by nongeneticists.Genet Med 19 1, 112-120.

Using a Medical Intranet of Things System to Prevent Bed Falls in an Acute Care Hospital: A Pilot Study.

BACKGROUND: Hospitalized patients in the United States experience falls at a rate of 2.6 to 17.1 per 1000 patient-days, with the majority occurring when a patient is moving to, from, and around the bed. Each fall with injury costs an average of US $14,000. OBJECTIVE: The aim was to conduct a technology evaluation, including feasibility, usability, and user experience, of a medical sensor-based Intranet of things (IoT) system in facilitating nursing response to bed exits in an acute care hospital. METHODS: Patients 18 years and older with a Morse fall score of 45 or greater were recruited from a 35-bed medical-surgical ward in a 317-bed Massachusetts teaching hospital. Eligible patients were recruited between August 4, 2015 and July 31, 2016. Participants received a sensor pad placed between the top of their mattress and bed sheet. The sensor pad was positioned to monitor movement from patients' shoulders to their thighs. The SensableCare System was evaluated for monitoring patient movement and delivering timely alerts to nursing staff via mobile devices when there appeared to be a bed-exit attempt. Sensor pad data were collected automatically from the system. The primary outcomes included number of falls, time to turn off bed-exit alerts, and the number of attempted bed-exit events. Data on patient falls were collected by clinical research assistants and confirmed with the unit nurse manager. Explanatory variables included room locations (zones 1-3), day of the week, nursing shift, and Morse Fall Scale (ie, positive fall history, positive secondary diagnosis, positive ambulatory aid, weak impaired gait/transfer, positive IV/saline lock, mentally forgets limitations). We also assessed user experience via nurse focus groups. Qualitative data regarding staff interactions with the system were collected during two focus groups with 25 total nurses, each lasting approximately 1.5 hours. RESULTS: A total of 91 patients used the system for 234.0 patient-days and experienced no bed falls during the study period. On average, patients were assisted/returned to bed 46 seconds after the alert system was triggered. Response times were longer during the overnight nursing shift versus day shift (P=.005), but were independent of the patient's location on the unit. Focus groups revealed that nurses found the system integrated well into the clinical nursing workflow and the alerts were helpful in patient monitoring. CONCLUSIONS: A medical IoT system can be integrated into the existing nursing workflow and may reduce patient bed fall risk in acute care hospitals, a high priority but an elusive patient safety challenge. By using an alerting system that sends notifications directly to nurses' mobile devices, nurses can equally respond to unassisted bed-exit attempts wherever patients are located on the ward. Further study, including a fully powered randomized controlled trial, is needed to assess effectiveness across hospital settings.

Effective communication of molecular genetic test results to primary care providers.

PURPOSE: We evaluated a template for molecular genetic test reports that was developed as a strategy to reduce communication errors between the laboratory and ordering clinician. METHODS: We surveyed 1,600 primary care physicians to assess satisfaction, ease of use, and effectiveness of genetic test reports developed using our template and reports developed by clinical laboratories. Mean score differences of responses between the reports were compared using t-tests. Two-way analysis of variance evaluated the effect of template versus standard reports and the influence of physician characteristics. RESULTS: There were 396 (24%) respondents. Template reports had higher scores than the standard reports for each survey item. The gender and specialty of the physician did not influence scores; however, younger physicians gave higher scores regardless of report type. There was significant interaction between report type and whether physicians ordered or reviewed any genetic tests (none versus at least one) in the past year, P = 0.005. CONCLUSION: For each survey item assessing satisfaction, ease of use, and effectiveness, physicians gave higher ratings to genetic test reports developed with the template than standard reports used by clinical laboratories. Physicians least familiar with genetic test reports, and possibly having the greatest need for better communication, were best served by the template reports.

Contributions of Glucose and Hemoglobin A1c Measurements in Diabetes Screening.

OBJECTIVES: Given the long-term consequences of untreated diabetes, patients benefit from timely diagnoses. Payer policies often recognize glucose but not hemoglobin A1c (HbA1c) for diabetes screening. This study evaluates the different information that glucose and HbA1c provide for diabetes screening. METHODS: We conducted a retrospective review of national clinical laboratory testing during 2020 when glucose and HbA1c were ordered for routine diabetes screening, excluding patients with known diabetes, out-of-range glucose, or metabolic syndrome. RESULTS: Of 15.47 million glucose and HbA1c tests ordered simultaneously, 672,467 (4.35%) met screening inclusion criteria; 116,585 (17.3%) were excluded because of diabetes-related conditions or the specimen was nonfasting, leaving 555,882 result pairs. More than 1 in 4 patients 60 years of age or older with glucose within range had an elevated HbA1c level. HbA1c claims were denied more often for Medicare beneficiaries (38,918/65,273 [59.6%]) than for other health plans combined (23,234/291,764 [8.0%]). CONCLUSIONS: Although many health plans do not cover HbA1c testing for diabetes screening, more than 1 in 4 glucose screening patients 60 years of age or older with an in-range glucose result had a concurrent elevated HbA1c result. Guideline developers and health plans should explicitly recognize that glucose and HbA1c provide complementary information and together offer improved clinical utility for diabetes screening.

Strategies for laboratory professionals to drive laboratory stewardship.

Appropriate laboratory testing is critical in today's healthcare environment that aims to improve patient care while reducing cost. In recent years, laboratory stewardship has emerged as a strategy for assuring quality in laboratory medicine with the goal of providing the right test, for the right patient, at the right time. Implementing a laboratory stewardship program now presents a valuable opportunity for laboratory professionals to exercise leadership within health systems and to drive change toward realizing aims in healthcare. The proposed framework for program implementation includes 5 key elements: 1) a clear vision and organizational alignment; 2) appropriate skills for program execution and management; 3) resources to support the program; 4) incentives to motivate participation; and, 5) a plan of action that articulates program objectives and metrics. This framework builds upon principles of change management, with emphasis on engagement with clinical and administrative stakeholders and the use of clinical data as the basis for change. These strategies enable laboratory professionals to cultivate organizational support for improving laboratory use and take a leading role in providing high-quality patient care.

Changes in Test Volumes During Coronavirus Disease 2019 (COVID-19): A Laboratory Stewardship Opportunity.

CONTEXT.­: Coronavirus disease 2019 (COVID-19) changed the dynamics of health care delivery, shifting patient priorities and deferring care perceived as less urgent. Delayed or eliminated care may place patients at risk for adverse outcomes. OBJECTIVE.­: To identify opportunities for laboratory test stewardship to close potential gaps in care created by the COVID-19 pandemic. DESIGN.­: The study was a retrospective time series design examining laboratory services received before and during the COVID-19 pandemic at a large metropolitan health system serving women and children. RESULTS.­: Laboratory test volumes displayed 3 distinct patterns: (1) a decrease during state lockdown, followed by near-complete or complete recovery; (2) no change; and (3) a persistent decrease. Tests that diagnose or monitor chronic illness recovered only partially. For example, hemoglobin A1c initially declined 80% (from 2232 for April 2019 to 452 for April 2020), and there was a sustained 16% drop (28-day daily average 117 at August 30, 2019, to 98 at August 30, 2020) 4 months later. Blood lead dropped 39% (from 2158 for April 2019 to 1314 for April 2020) and remained 23% lower after 4 months. CONCLUSIONS.­: The pandemic has taken a toll on patients, practitioners, and health systems. Laboratory professionals have access to data that can provide insight into clinical practice and identify pandemic-related gaps in care. During the pandemic, the biggest patient threat is underuse, particularly among tests to manage chronic diseases and for traditionally underserved communities and people of color. A laboratory stewardship program, focused on peri-pandemic care, positions pathologists and other laboratory professionals as health care leaders with a commitment to appropriate, equitable, and efficient care.

Linking Statistics With Testing Policy to Manage COVID-19 in the Community.

OBJECTIVES: To determine the public health surveillance severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing volume needed, both for acute infection and seroprevalence. METHODS: Required testing volumes were developed using standard statistical methods based on test analytical performance, disease prevalence, desired precision, and population size. RESULTS: Widespread testing for individual health management cannot address surveillance needs. The number of people who must be sampled for public health surveillance and decision making, although not trivial, is potentially in the thousands for any given population or subpopulation, not millions. CONCLUSIONS: While the contributions of diagnostic testing for SARS-CoV-2 have received considerable attention, concerns abound regarding the availability of sufficient testing capacity to meet demand. Different testing goals require different numbers of tests and different testing strategies; testing strategies for national or local disease surveillance, including monitoring of prevalence, receive less attention. Our clinical laboratory and diagnostic infrastructure are capable of incorporating required volumes for many local, regional, and national public health surveillance studies into their current and projected testing capacity. However, testing for surveillance requires careful design and randomization to provide meaningful insights.

Components of care vary in importance for overall patient-reported experience by type of hospitalization.

BACKGROUND: Patients are hospitalized for disparate conditions and procedures. Patient experiences with care may depend on hospitalization type (HT). OBJECTIVES: Determine whether the contributions of patient experience composite measures to overall hospital ratings on the Hospital Consumer Assessment of Healthcare Providers and Systems Survey vary by HT. RESEARCH DESIGN: In cross-sectional observational data, we defined 24 HTs using major diagnostic category and service line (medical, surgical, or obstetrical). To assess the importance of each composite for each HT, we calculated the simultaneous partial correlations of 7 composite scores with an overall hospital rating, controlling for patient demographics. SUBJECTS: Nineteen thousand seven hundred twenty English- or Spanish-speaking adults with nonpsychiatric primary diagnoses discharged home 12/02-1/03 after an overnight inpatient stay in any of 132 general acute care hospitals in 3 states. MEASURES: Patient-reported doctor communication, nurse communication, staff responsiveness, physical environment, new medicines explained, pain control, and postdischarge information; overall 0 to 10 rating of care. RESULTS: Nurse communication was most important overall, with a 0.34 average partial correlation (range: 0.17-0.49; P < 0.05 and among the 3 most important composites for all HTs). Discharge information was least important (0.05 average partial correlation; P < 0.05 for 10 of 24 HTs). Interactions demonstrated significant (P < 0.05) variation in partial correlations by HT for 5 of 7 composites (all but responsiveness and environment), with nurse communication, doctor communication, and pain control showing the most variation (F > 2, P < 0.05). CONCLUSIONS: The importance of patient experience dimensions differs substantially and varies by HT. Quality improvement efforts should target those aspects of patient experience that matter most for each HT.

Adherence to quality indicators and survival in patients with breast cancer.

BACKGROUND: International initiatives increasingly advocate physician adherence to clinical protocols that have been shown to improve outcomes, yet the process-outcome relationship for adhering to breast cancer care protocol is unknown. OBJECTIVE: This study explores whether 100% adherence to a set of quality indicators applied to individuals with breast cancer is associated with better survival. RESEARCH DESIGN AND SUBJECTS: Ten quality indicators (4 diagnosis-related and 6 treatment-related indicators) were used to measure the quality of care in 1378 breast cancer patients treated from 1995 to 2001. Adherence to each indicator was based on the number of procedures performed divided by the number of patients eligible for that procedure. The main analysis of adherence was dichotomous (ie, 100% adherence vs. <100% adherence). MEASURES: The outcome measures studied were 5-year overall survival and progression-free survival, calculated using the Kaplan-Meier method. The Cox's proportional hazard regression model was used for univariate and multivariate analyses. RESULTS: Most patients received care that demonstrated good adherence to the quality indicators. Multivariate analysis revealed that 100% adherence to entire set of quality indicators was significantly associated with better overall survival [hazard ratio (HR): 0.46; 95% confidence interval (CI): 0.33-0.63] and progression-free survival (HR 0.51; 95% CI, 0.39-0.67). One hundred percent adherence to treatment indicators alone was also associated with statistically significant improvements in overall and progression-free survivals. CONCLUSIONS: Our study strongly supports that 100% adherence to evidence supported quality-of-care indicators is associated with better survival rates for breast cancer patients and should be a priority for practitioners.

Comparing process- and outcome-oriented approaches to voluntary incident reporting in two hospitals.

BACKGROUND: The debate over whether patient safety efforts should focus on adverse events or errors logically extends to voluntary incident reporting in hospitals. Reports emphasizing adverse events take an outcome-oriented approach to improving quality, whereas those emphasizing errors take a process-oriented approach. These approaches were compared in an analysis of 2,228 paper incident reports for 16,575 randomly selected inpatients at an academic hospital and a community hospital in the United States in 2001. METHODS: Measures were developed for process orientation (care varying from the norm) and outcome orientation (physical or nonphysical patient harms, regardless of cause); preventability; and any patient, system, and provider factors contributing to the incidents. RESULTS: Fifty percent of the reports were only process-oriented, 35% only outcome-oriented, and 10% both. Exclusively process-oriented reports were better than exclusively outcome-oriented reports for ascertaining preventability (as determined from 96% versus 25% of reports, respectively), system factors (described in 49% versus 5%), and provider factors (37% versus 4%) but were worse for identifying patient factors (5% versus 63%), all atp < .01. DISCUSSION: Many incident reports contain process information or outcome information but not both. Outcome-oriented reports lack the information needed to assess risk and formulate safety improvements; therefore, follow-up investigations are required. Because process-oriented reports include the necessary information more often, they are more directly useful for improving patient safety. Hospitals should focus voluntary incident reporting systems on capturing process-oriented reports and should train staff to describe contributing factors. This focus should not only improve the quality of the information in the reports but is consistent with efforts to promote a blame-free reporting culture.

Programmable infusion pumps in ICUs: an analysis of corresponding adverse drug events.

BACKGROUND: Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. OBJECTIVES: To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software ("smart pump") and to suggest potential improvements in smart-pump design. DESIGN: Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 hospitals replaced conventional pumps with smart pumps. The smart pumps alerted users when programmed to deliver duplicate infusions or continuous-infusion doses outside hospital-defined ranges. PARTICIPANTS: 4,604 critically ill adults at 1 academic and 1 nonacademic hospital. MEASUREMENTS: Preventable IV-ADEs matching smart-pump features and errors involved in preventable IV-ADEs. RESULTS: Of 100 preventable IV-ADEs identified, 4 involved errors matching smart-pump features. Two occurred before and 2 after smart-pump implementation. Overall, 29% of preventable IV-ADEs involved overdoses; 37%, failures to monitor for potential problems; and 45%, failures to intervene when problems appeared. Error descriptions suggested that expanding smart pumps' capabilities might enable them to prevent more IV-ADEs. CONCLUSION: The smart pumps we evaluated are unlikely to reduce preventable IV-ADEs in ICUs because they address only 4% of them. Expanding smart-pump capabilities might prevent more IV-ADEs.

Systematic Review of Non-ASCP Choosing Wisely Recommendations Relevant to Pathology and Laboratory Medicine.

OBJECTIVES: To determine non-American Society for Clinical Pathology pathology- and laboratory-related Choosing Wisely recommendations that drive effective test utilization in the laboratory. METHODS: Data were collected via a two-part web-based survey distributed to a broad sample of pathologists and laboratory professionals from a variety of institutions. RESULTS: Pathologists' most relevant recommendation: "Do not transfuse more units of blood than absolutely necessary"; highest priority: "Do not transfuse more than the minimum number of RBC units necessary to relieve symptoms of anemia or to return a patient to a safe hemoglobin range (7-8 g/dL in stable, noncardiac inpatients)." Laboratory professionals' most relevant recommendation: "Avoid testing for a Clostridium difficile infection in the absence of diarrhea"; highest priority: "Do not routinely transfuse stable, asymptomatic hospitalized patients with a hemoglobin level greater than 7 to 8 g/dL." CONCLUSIONS: Most of the highest priority, most relevant recommendations among those surveyed concerned utilization of blood products and transfusion management.

Health Sector Reform in the Kurdistan Region-Iraq: Primary Care Management Information System, Physician Dual Practice Finance Reform, and Quality of Care Training.

Since 2010, the RAND Corporation has worked with the Ministry of Health and Ministry of Planning of the Kurdistan Regional Government to develop and implement initiatives for improving the region's health care system through analysis, planning, and development of analytical tools. This third phase of the project (reflecting work completed in 2013-2015) focused on development and use of a primary care management information system; health financing reform, focusing on policy reform options to solve the problem of physician dual practice, in which physicians practice in both public and private settings; and hospital patient safety training within the context of health quality improvement. Most main primary health care centers serve too many people, and most sub-centers serve too few people. Staffing by physicians, nurses, dentists, and pharmacists is uneven across the region. The data also identified centers where laboratory, X-ray, and/or other equipment should be repaired or replaced and where users should be trained. Though the required workweek is 35 hours, and all physicians are paid for these 35 hours, most physicians spent only three or four hours per day working in the public sector. The remainder of the time was often spent working in the private sector, where pay is much higher. The vast majority of physicians (over 80 percent) indicated that if pay were higher and public-sector resources were increased, they would prefer to work only in the public sector. To resolve the problems associated with dual practice, the authors recommend full separation between public- and private-sector practice.

The many faces of error disclosure: a common set of elements and a definition.

BACKGROUND: Patients want to know when errors happen in their care. Professional associations, ethicists, and patient safety experts endorse disclosure of medical error to patients. Surveys of physicians show that they believe harmful errors should be disclosed to patients, yet errors are often not disclosed. OBJECTIVE: To understand the discrepancy between patients' expectations and physicians' behavior concerning error disclosure. DESIGN, SETTING, AND PARTICIPANTS: We conducted focus groups to determine what constitutes disclosure of medical error. Twenty focus groups, 4 at each of 5 academic centers, included 204 hospital administrators, physicians, residents, and nurses. APPROACH: Qualitative analysis of the focus group transcripts with attention to examples of error disclosure by clinicians and hospital administrators. RESULTS: Clinicians and administrators considered various forms of communication about errors to be error disclosure. Six elements of disclosure identified from focus group transcripts characterized disclosures ranging from Full disclosure (including admission of a mistake, discussion of the error, and a link from the error to harm) to Partial disclosures, which included deferral, misleading statements, and inadequate information to "connect the dots." Descriptions involving nondisclosure of harmful errors were uncommon. CONCLUSIONS: Error disclosure may mean different things to clinicians than it does to patients. The various forms of communication deemed error disclosure by clinicians may explain the discrepancy between error disclosure beliefs and behaviors. We suggest a definition of error disclosure to inform practical policies and interventions.