Search

Introduction An important cause of laboratory test misordering and overutilization is clinician confusion between tests with similar sounding names or similar indications. We identified an area of test ordering confusion with iron studies that involves total iron binding capacity (TIBC), transferrin, and transferrin saturation. We observed concurrent ordering of direct transferrin along with TIBC at many hospitals within our health system and suspected this was unnecessary. Methods We extracted patient test results for transferrin, TIBC and other biomarkers. Using these data, we evaluated both patterns of test utilization and test result concordance. We implemented a clinical decision support (CDS) alert to discourage unnecessary orders for direct transferrin. Results Using linear regression, we were able to predict transferrin from either TIBC alone or TIBC with other analytes with a high degree of accuracy, demonstrating that in most cases, direct transferrin in combination with TIBC provides little if any additional diagnostic information beyond TIBC alone. The CDS alert proved highly effective in reducing transferrin test utilization at four different hospitals. Conclusions Concurrent ordering of direct transferrin and TIBC should usually be avoided. Removal of transferrin or TIBC from the test menu or implementation of CDS may improve utilization of these tests.

Objectives To evaluate the use of a provider ordering alert to improve laboratory efficiency and reduce costs. Methods We conducted a retrospective study to assess the use of an institutional reflex panel for monoclonal gammopathy evaluation. We then created a clinical decision support (CDS) alert to educate and encourage providers to change their less-efficient orders to the reflex panel. Results Our retrospective analysis demonstrated that an institutional reflex panel could be safely substituted for a less-efficient and higher-cost panel. The implemented CDS alert resulted in 79% of providers changing their high-cost order panel to an order panel based on the reflex algorithm. Conclusions The validated decision support alert demonstrated high levels of provider acceptance and directly led to operational and cost savings within the laboratory. Furthermore, these studies highlight the value of laboratory involvement with CDS efforts to provide agile and targeted provider ordering assistance.

Objectives Peripheral blood flow cytometry (PBFC) is useful for evaluating circulating hematologic malignancies (HM) but has limited diagnostic value for screening. We used machine learning to evaluate whether clinical history and CBC/differential parameters could improve PBFC utilization. Methods PBFC cases with concurrent/recent CBC/differential were split into training (n = 626) and test (n = 159) cohorts. We classified PBFC results with abnormal blast/lymphoid populations as positive and used two models to predict results. Results Positive PBFC results were seen in 58% and 21% of training cases with and without prior HM (P < .001). % neutrophils, absolute lymphocyte count, and % blasts/other cells differed significantly between positive and negative PBFC groups (areas under the curve [AUC] > 0.7). Among test cases, a decision tree model achieved 98% sensitivity and 65% specificity (AUC = 0.906). A logistic regression model achieved 100% sensitivity and 54% specificity (AUC = 0.919). Conclusions We outline machine learning-based triaging strategies to decrease unnecessary utilization of PBFC by 35% to 40%.

Introduction Laboratory test interferences can cause spurious test results and patient harm. Knowing the frequency of various interfering substances in patient populations likely to be tested with a particular laboratory assay may inform test development, test utilization and strategies to mitigate interference risk. Methods We developed REACTIR (Real Evidence to Assess Clinical Testing Interference Risk), an approach using real world data to assess the prevalence of various interfering substances in patients tested with a particular type of assay. REACTIR uses administrative real world data to identify and subgroup patient cohorts tested with a particular laboratory test and evaluate interference risk. Results We demonstrate the application REACTIR to point of care (POC) blood glucose testing. We found that exposure to several substances with the potential to interfere in POC blood glucose tests, including N-acetyl cysteine (NAC) and high dose vitamin C was uncommon in most patients undergoing POC glucose tests with several key exceptions, such as burn patients receiving high dose IV-vitamin C or acetaminophen overdose patients receiving NAC. Conclusions Findings from REACTIR may support risk mitigation strategies including targeted clinician education and clinical decision support. Likewise, adaptations of REACTIR to premarket assay development may inform optimal assay design and assessment.

ObjectivesAn unfortunate reality of laboratory medicine is that blood specimens collected from one patient occasionally get mislabeled with identifiers from a different patient, resulting in so-called “wrong blood in tube” (WBIT) errors and potential patient harm. Here, we sought to develop a machine learning-based, multianalyte delta check algorithm to detect WBIT errors and mitigate patient harm.MethodsWe simulated WBIT errors within sets of routine inpatient chemistry test results to develop, train, and evaluate five machine learning-based WBIT detection algorithms.ResultsThe best-performing WBIT detection algorithm we developed was based on a support vector machine and incorporated changes in test results between consecutive collections across 11 analytes. This algorithm achieved an area under the curve of 0.97 and considerably outperformed traditional single-analyte delta checks.ConclusionsMachine learning-based multianalyte delta checks may offer a practical strategy to identify WBIT errors prior to test reporting and improve patient safety.

Objectives We evaluated changes in the testing menu, volume, and positivity rates for tick-borne illnesses in a New England medical center over an 11-year time frame. Methods Testing data were obtained by a retrospective review utilizing searchable data from a laboratory information system archive. Results Testing for tick-borne infections (TBI) increased 5.3-fold over an 11-year time period and the number of positive test results increased threefold. Annual rates for Lyme serology positivity varied from 14% to 29% and for western blot confirmation from 26% to 48%. Test volumes and the number of positive results increased for all TBI endemic to our region. Conclusions Our results confirm national trends suggesting increasing rates of TBI and substantially increased testing. This may reflect a greater incidence of TBI in our region and/or increased awareness of these infections.

A Man with Leg Weakness, Recurrent Falls, and Anemia A 64-year-old man was admitted to the hospital because of recurrent falls. He had proximal muscle weakness, orthostatic hypotension, and anemia....

In a previous study we reported on the impact of point-of-care testing (POCT) on practice efficiency in an academic primary care practice that was established to develop new models of care delivery. Here we report a follow-on confirmation study in a more typical primary care practice in the community.In this observational study with a retrospective comparison analysis we measured metrics of practice efficiency on two patient cohorts: those that did not receive POCT and those that did.In the patient cohort that received POCT there was a 99% reduction in letters to patients (p0.001), a 75% decrease in calls to patients (not significant due to small numbers), a 50% reduction in follow-up tests per visit (p=0.044) and a 38% reduction in follow-up visits due to abnormal test results (p=0.178). Financial analysis including testing costs, revenues and efficiency gains to the practice demonstrated a net financial benefit of $11.90-14.74 per patient visit.Our data confirm the earlier published findings that POCT can improve metrics of practice efficiency in a primary care practice.

Objectives We sought to address concerns regarding recurring inpatient laboratory test order practices (daily laboratory tests) through a multifaceted approach to changing ordering patterns. Methods We engaged in an interdepartmental collaboration to foster mindful test ordering through clinical policy creation, electronic clinical decision support, and continuous auditing and feedback. Results Annualized daily order volumes decreased from approximately 25,000 to 10,000 during a 33-month postintervention review. This represented a significant change from preintervention order volumes (95% confidence interval, 0.61-0.64; P < 10-16). Total inpatient test volumes were not affected. Conclusions Durable changes to inpatient order practices can be achieved through a collaborative approach to utilization management that includes shared responsibility for establishing clinical guidelines and electronic decision support. Our experience suggests auditing and continued feedback are additional crucial components to changing ordering behavior. Curtailing daily orders alone may not be a sufficient strategy to reduce in-laboratory costs.

ObjectivesWe evaluated trends in non-Lyme disease tick-borne disease (NLTBI) testing at a national reference laboratory.MethodsTesting data performed at Quest Diagnostics during 2010 to 2016 were analyzed nationally and at the state level.ResultsTesting and positivity for most NLTBIs increased dramatically from 2010 through 2016 based on testing from a large reference laboratory. The number of positive cases, though not as stringent as criteria for public health reporting, generally exceeds that reported by the Centers for Disease Control and Prevention. The frequency of NLTBI in the US is seasonal but testing activity and positive test results are observed throughout all months of the year. Positive results for NLTBI testing mostly originated from a limited number of states, indicating the geographic concentration and distribution of NLTBIs reported in this study.ConclusionsThis report provides an important complementary source of data to best understand trends in and spread of NLTBI.

Objectives We evaluated trends in Lyme disease (LD) testing at a national reference laboratory. Methods LD screening enzyme immunoassay and Western blot testing data performed at Quest Diagnostics during 2010 to 2016 were analyzed nationally and at the state level. Results Overall, 593,800 (11.3%) results were positive of 5,255,636 tests. There was an increase in the rate of positivity over the last 2 years of the study and an increase in the number of positive tests in 2016. Positive tests were observed in all 50 states and the District of Columbia. New York had the most positive tests, whereas Connecticut had the highest positivity rate when normalized to state populations. Some states with historically low rates of LD (eg, Texas, Florida, and California) showed significant increases in testing and positivity rates over time. Conclusions LD testing and positivity have increased in recent years, including in states not historically associated with the disease.

A 66-year-old man presented with malaise, weakness, hypercalcemia, and acute kidney injury. CT of the abdomen and pelvis revealed no evidence of cancer; CT of the chest revealed a sclerotic lesion of the eighth rib. Additional tests were performed, and a diagnosis was made.

Objectives While clinical laboratories report most test results as individual numbers, findings, or observations, clinical diagnosis usually relies on the results of multiple tests. Clinical decision support that integrates multiple elements of laboratory data could be highly useful in enhancing laboratory diagnosis. Methods Using the analyte ferritin in a proof of concept, we extracted clinical laboratory data from patient testing and applied a variety of machine-learning algorithms to predict ferritin test results using the results from other tests. We compared predicted with measured results and reviewed selected cases to assess the clinical value of predicted ferritin. Results We show that patient demographics and results of other laboratory tests can discriminate normal from abnormal ferritin results with a high degree of accuracy (area under the curve as high as 0.97, held-out test data). Case review indicated that predicted ferritin results may sometimes better reflect underlying iron status than measured ferritin. Conclusions These findings highlight the substantial informational redundancy present in patient test results and offer a potential foundation for a novel type of clinical decision support aimed at integrating, interpreting, and enhancing the diagnostic value of multianalyte sets of clinical laboratory test results.

Background Increasing the value of health care delivery is a national priority, and providers face growing pressure to reduce cost while improving quality. Ample opportunity exists to increase efficiency and quality simultaneously through the application of systems engineering science. Objective We examined the hypothesis that Lean-based reorganization of laboratory process flow would improve laboratory turnaround times (TAT) and reduce waste in the system. Methods This study was a prospective, before-after analysis of laboratory process improvement in a teaching hospital emergency department (ED). The intervention included a reorganization of laboratory sample flow based in systems engineering science and Lean methodologies, with no additional resources. The primary outcome was the median TAT from sample collection to result for 6 tests previously performed in an ED kiosk. Results After the intervention, median laboratory TAT decreased across most tests. The greatest decreases were found in "reflex tests" performed after an initial screening test: troponin T TAT was reduced by 33 minutes (86 to 53 minutes; 99% confidence interval, 30-35 minutes) and urine sedimentation TAT by 88 minutes (117 to 29 minutes; 99% confidence interval, 87-90 minutes). In addition, troponin I TAT was reduced by 12 minutes, urinalysis by 9 minutes, and urine human chorionic gonadotropin by 10 minutes. Microbiology rapid testing TAT, a "control," did not change. Conclusions In this study, Lean-based reorganization of laboratory process flow significantly increased process efficiency. Broader application of systems engineering science might further improve health care quality and capacity while reducing waste and cost.

A 49-year-old man was admitted to this hospital after being found unresponsive outdoors; he was next to a half-filled bottle of cloudy liquid with pill fragments. An electrocardiogram showed a QTc interval of 501 msec. A diagnostic test was performed.

We evaluated the effectiveness of an expanded point-of-care (POCT) site inspection checklist over an extended 8-y period.A retrospective review of site inspection deficiency reports in a large academic medical center from 2010 to 2017 (year to date).There was a significant decrease in the number of cited deficiencies per site/inspection from 2010 (3.17) to 2017 (0.27) (p0.001). The percentage of sites without deficiencies steadily increased from 2010 (8.7%) to 2017 (80.7%) (p0.001). The most common citation was documentation of competency assessment followed by results documentation and annual procedure review.Regular inspections of sites performing POCT are necessary to maintain regulatory compliance. Over time significant improvements in compliance are achievable.

Objectives: Point-of-care laboratory testing (POCT) offers reduced turnaround time and may promote improved operational efficiency. Few studies have been reported that document improvements from implementing POCT in primary care. Methods: We measured metrics of practice efficiency in a primary care practice before and after implementation of POCT, including the total number of tests ordered, letters and phone calls to patients, and revisits due to abnormal test results. We performed a cost and revenue analysis. Results: Following implementation of POCT, there was a 21% decrease in tests ordered per patient ( P < .0001); a decrease in follow-up phone calls and letters by 89% and 85%, respectively ( P < .0001 and P < .0001); and a 61% decrease in patient revisits ( P = .0002). Estimated testing revenues exceeded expenses by $6.62 per patient, and potential cost savings from improved efficiency were $24.64 per patient. Conclusions: POCT can significantly improve clinical operations with cost reductions through improved practice efficiency.

Objectives: To assess the frequency, magnitude, and prognostic significance of elevations in cardiac troponin T in noncardiac critically ill patients, including elevations at levels below the limit of detection of traditional assays. Methods: Using a high-sensitivity assay, we measured troponin T (high-sensitivity troponin T [hsTnT]) in 451 unique patients within 12 hours of their admission to a noncardiac medical intensive care unit. Outcomes of patients, grouped by hsTnT level, were compared. Results: Overall, 98% of the study patients had detectable levels of hsTnT (>3 ng/L), and 33% had levels above the diagnostic cutoff of a traditional fourth-generation cardiac troponin T assay. Patient groups with higher hsTnT levels had markedly higher rates of in-hospital mortality ( P < .001) and longer stays in the hospital and intensive care unit ( P < .01). Conclusions: In noncardiac critically ill patients, cardiac troponin T elevations are common but often at levels undetectable by traditional assays. hsTnT elevations predict a more complex clinical course and an increased risk of death.

Information systems provide a critical link between clinical laboratories and the clinicians and patients they serve. Strategic deployment of informatics resources can enable a wide array of utilization initiatives and can substantially improve the appropriateness of test selection and results interpretation. In this article, we review information systems including computerized provider order entry (CPOE) systems, laboratory information systems (LISs), electronic health records (EHRs), laboratory middleware, knowledge management systems and systems for data extraction and analysis, and describe the role that each can play in utilization management. We also discuss specific utilization strategies that laboratories can employ within these systems, citing examples both from our own institution and from the literature. Finally, we review how emerging applications of decision support technologies may help to further refine test utilization, "personalize" laboratory diagnosis, and enhance the diagnostic value of laboratory testing.

Objectives: The biomarker suppression of tumorigenicity 2 (ST2) is a well-established clinical biomarker of cardiac strain and is frequently elevated in a variety of cardiac conditions. Here, we sought to evaluate the prognostic value of ST2 in critically ill medical intensive care unit (MICU) patients without primary cardiac illness. Methods: We measured ST2 and high-sensitivity troponin T (hsTnT) on plasma specimens collected on 441 patients following admission to a noncardiac MICU and evaluated the prognostic power of ST2 both alone and in multivariate models. Results: Of these critically ill patients, 96% exhibited ST2 concentrations above the reference interval. ST2 concentrations were highly predictive of intensive care unit and hospital length of stay, as well as in-hospital mortality, with high concentrations predicting a poor prognosis. Rates of in-hospital mortality were more than four times higher in patients with ST2 concentrations in the highest compared with the lowest quartile. In multivariate analysis, ST2 remained an important predictor of death after adjustment for age, hsTnT, and common diagnoses. Conclusions: ST2 is increased and predictive of prognosis in critically ill patients without primary cardiac disease, suggesting that critically ill patients may often have unrecognized cardiac injury. Clinical decision support algorithms incorporating ST2 and hsTnT results may be useful in patient risk stratification.

Preanalytic laboratory testing errors are often difficult to identify. We demonstrate how laboratories can integrate statistical models with clinical judgment to develop protocols for preanalytic error detection. Specifically, we developed a protocol to identify spuriously elevated glucose values resulting from improper "line draws" or related phlebotomy errors. Using a decision tree-generating algorithm and an annotated set of training data, we generated decision trees to classify critically elevated glucose results as "real" or "spurious" based on available laboratory parameters. Decision trees revealed that a 30-day patient-specific average glucose concentration lower than 186.3 mg/dL (10.3 mmol/L), a current glucose concentration higher than 663 mg/dL (37 mmol/L), and an anion gap lower than 16.5 mEq/L (16.5 mmol/L) suggested a spurious result. We then used the results from the decision tree analysis to inform the implementation of a clinical protocol that significantly improved the laboratory's identification of spurious results. Similar approaches may be useful in developing protocols to identify other errors or to assist in clinical interpretation of results.

Objectives: While acute kidney injury (AKI) can be diagnosed based on specified increases in a patient’s plasma creatinine level, standard creatinine reporting methods typically only flag creatinine results as abnormal when outside the reference range and often fail to identify rising creatinine values indicative of AKI. Here, we evaluate the impact of this limitation in standard creatinine reporting and develop and implement an enhanced creatinine reporting algorithm. Methods: We evaluated 59,712 plasma creatinine results collected over approximately 3 months, using computational simulations and statistical analyses. Results: Our analyses demonstrated that 29% of creatinine results substantially increased over the patient’s baseline and concerning for AKI remained within the normal reference range. These concerning results would not be flagged as abnormal using standard reporting. Likewise, we found that simple delta checks are also insensitive at AKI detection. To improve creatinine reporting, we developed and implemented an algorithm within our laboratory information system to alert clinicians to rising creatinine results, which we describe in this report. Conclusion: While both creatinine reference limits and simple delta checks are insensitive for AKI identification, a simple algorithm can be implemented within a common laboratory information system to enhance AKI identification.

Background Conductivity based point-of-care hematocrit with calculated hemoglobin devices serves an important role in clinical scenarios where time sensitive transfusion decisions are necessary. However, questions about the appropriateness of conductivity based assays in certain patient populations (patients on cardiopulmonary bypass and those receiving high volumes of intravenous fluids or autologous blood transfusions) have been raised. The clinical suitability of POC devices for these applications necessitates that they be accurate and that the results are interchangeable with central laboratory methods. Methods We performed hematocrit and hemoglobin analysis on 225 clinical samples using the i-STAT instrument, a standard reference method for hematocrit (manual spun) and other common methods on both cardiopulmonary bypass and non-cardiopulmonary bypass patients. Results The i-STAT hematocrit and hemoglobin showed close agreement to comparison methods with minimal bias. Median test results were not clinically or statistically different between those measured on the i-STAT and those measured using the manual spun hematocrit reference method (p = 0.4085, Wilcoxon signed rank test) or the Sysmex photometric hemoglobin method (p = 0.2728, Wilcoxon signed rank test). The results on the i-STAT were statistically different from those obtained on the Sysmex for hematocrit (p Conclusion The i-STAT hematocrit and hemoglobin performs well when compared to the hematocrit reference method and other common methods for both hematocrit and hemoglobin. Some differences between non-reference methods may be observed, but these were not considered clinically significant.

To determine the performance and frequency of protein C reagents currently used by clinical laboratories, we analyzed North American Specialized Coagulation Laboratory Association (NASCOLA) protein C proficiency testing data from 6 surveys conducted in 2009 and 2010 (2009-1 to 2009-3 and 2010-1 to 2010-3). Interlaboratory coefficients of variation (CV) for commonly used reagents on a survey with normal protein C ranged from 8% to 12% for antigenic assays, from 4% to 7% for chromogenic activity assays, and from 7% to 22% for clot-based activity assays. CVs for commonly used reagents on specimens with abnormal protein C ranged from 15% to 24% for antigenic, 4% to 11% for chromogenic, and 10% to 17% for clot-based assays (averaged across 3 surveys). Some reagents were used by relatively few laboratories and therefore additional study may be needed for those reagents. For all commonly used reagents, biases were usually small and often not statistically significant. All assessed reagents were clinically accurate, and were considered acceptable options for a specialized coagulation laboratory.

Background Point-of-care devices for performing a prothrombin time/international normalized ratio (PT/INR) using capillary blood samples are being increasingly used to monitor patients receiving anticoagulation therapy. However, the performance of some devices has been shown to be suboptimal and there are only limited published data comparing specific devices to various central laboratory coagulation analyzers. We report an evaluation of the iSTAT PT/INR with a comparison to the Tcoag MDA II analyzer. Methods We obtained simultaneous capillary/venous samples on 20 healthy volunteers for a normal range study and on 50 anticoagulated patients for a clinical evaluation. Testing was performed by phlebotomists. We also obtained 68 near simultaneous capillary/venous test results for assessment of performance by non-laboratory personnel. The criteria for determining clinical equivalence of the iSTAT to the MDA II were (1) same clinical category (subtherapeutic INR 3) or (2) paired values within ≤ 0.4 INR. Results Forty nine of 50 patient sample pairs collected by phlebotomists showed acceptable clinical agreement. Sixty one (61) of 68 patient sample pairs collected by nurses showed acceptable agreement. In all discordant cases the differences were minor and would have resulted in either no or minimal change in therapy. Conclusions The iSTAT PT/INR compares well to the MDA II when performed by phlebotomists or nurses.