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.

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.

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.

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.

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.

Testing New Codes to Capture Post-Operative Care.

The Centers for Medicare & Medicaid Services (CMS) uses the resource-based relative value system to determine payment for physicians and nonphysician practitioners for their professional services. For many surgeries and other types of procedures, Medicare payment includes pre- and post-operative visits delivered during a global period of 10 or 90 days. Congress mandated that CMS collect data on the "number and level" of visits in the global period from a representative sample of physicians beginning January 1, 2017. At CMS's request, RAND developed a new set of nonpayment codes that could be used to capture the number and level of visits. In July 2016, CMS issued a proposed rule that included a slightly modified version of the codes developed by RAND and proposed to require their use by practitioners. Given that these codes had never been tested or used by practitioners, CMS asked RAND to pilot the proposed codes to determine whether practitioners understood and could accurately apply the codes. RAND's approach was to create a series of vignettes and to test the use of these vignettes using semi-structured interviews with a small set of physicians, followed by more-extensive testing through surveys with a larger group of physicians. This study provides recommendations on how to use vignettes to test new codes and uncover questions about such codes. Such input could be used to help refine instructions for using codes, as well as to potentially refine the codes themselves.

Health Sector Reform in the Kurdistan Region - Iraq: Financing Reform, Primary Care, and Patient Safety.

In 2010, the Kurdistan Regional Government asked the RAND Corporation to help guide reform of the health care system in the Kurdistan Region of Iraq. The overarching goal of reform was to help establish a health system that would provide high-quality services efficiently to everyone to prevent, treat, and manage physical and mental illnesses and injuries. This article summarizes the second phase of RAND's work, when researchers analyzed three distinct but intertwined health policy issue areas: development of financing policy, implementation of early primary care recommendations, and evaluation of quality and patient safety. For health financing, the researchers reviewed the relevant literature, explored the issue in discussions with key stakeholders, developed and assessed various policy options, and developed plans or approaches to overcome barriers and achieve stated policy objectives. In the area of primary care, they developed and helped to implement a new management information system. In the area of quality and patient safety, they reviewed relevant literature, discussed issues and options with health leaders, and recommended an approach toward incremental implementation.

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.

Strengthening laboratory systems in resource-limited settings.

Considerable resources have been invested in recent years to improve laboratory systems in resource-limited settings. We reviewed published reports, interviewed major donor organizations, and conducted case studies of laboratory systems in 3 countries to assess how countries and donors have worked together to improve laboratory services. While infrastructure and the provision of services have seen improvement, important opportunities remain for further advancement. Implementation of national laboratory plans is inconsistent, human resources are limited, and quality laboratory services rarely extend to lower tier laboratories (eg, health clinics, district hospitals). Coordination within, between, and among governments and donor organizations is also frequently problematic. Laboratory standardization and quality control are improving but remain challenging, making accreditation a difficult goal. Host country governments and their external funding partners should coordinate their efforts effectively around a host country's own national laboratory plan to advance sustainable capacity development throughout a country's laboratory system.

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.

The beginning of the second decade of the era of patient safety: implications and roles for the clinical laboratory and laboratory professionals.

Providing high quality, effective laboratory services is not new to the laboratory profession. The laboratory began examining its analytical quality in the 1920s when the American Society of Clinical Pathologists (ASCP) began a voluntary proficiency testing (PT) program with that was the predecessor of the College of American Pathologist's current PT program. The program focuses primarily on analytic quality, 1 of the 3 phases of what has become known as the "total testing process," a cyclical process conceptualized by the Centers for Disease Control (CDC) that provides a framework for assessing quality of laboratory services. Laboratory testing is particularly essential in the practice of medical genetics. The translation of human genomic research into clinical practice has resulted in a rapidly expanding portfolio of DNA-based tests for heritable conditions and markers of drug metabolism. This creates an opportunity for laboratory professionals with genetic training but also brings with it a threat to the quality of care that might result from inappropriate use of unfamiliar, costly and inappropriate testing. As for conventional laboratory tests, there is the need to identify and control all phases of the "total genetic testing process." An agenda for the second decade of the era of patient safety must be developed and here we offer a few key areas for practice improvement in laboratory medicine.

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.

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.