Point-of-care faecal calprotectin testing in patients with paediatric inflammatory bowel disease during the COVID-19 pandemic.

OBJECTIVES: Following the disruption of normal paediatric inflammatory bowel disease (IBD) services during the peak of the COVID-19 pandemic, we prospectively audited the first-time use of home faecal calprotectin testing. We aimed to provide an alternative to laboratory tests and to assess the value of home testing as part of our regular services going forward. METHODS: Home test kits as well as accompanying user instructions were made available to our patients with paediatric IBD that required faecal calprotectin test between 17 April and 12 August 2020. Once the user completed the test, results were automatically uploaded to the result portal and clinical staff were alerted. A user feedback questionnaire was sent to users that had completed the home test. RESULTS: Of the 54 patients, 41 (76%) aged between 4.7 and 18.1 years used the home test. A total of 45 home tests were done, one of which produced an invalid result. The decision to modify management was made in 12 (29%) of the patients, while 14 (34%) had no changes made and 15 (37%) required further assessment. Twenty (48.8%) responded to the questionnaire and 85% stated that they preferred the home test to the laboratory testing method. CONCLUSIONS: Home calprotectin tests were useful in guiding clinical management during a time when laboratory testing was less available. They may offer benefits as part of routine paediatric IBD monitoring to help target appointments and reduce unnecessary hospital attendances in the future.

Clinical biochemistry test eliminator providing cost-effectiveness with five algorithms.

Objectives: The purpose of this study is to investigate the elimination ratios of requested unnecessary tests and the cost-effectiveness to be achieved by means of 5 different algorithms with clinical validity defined in an artificial intelligence program.Methods: The clinician orders received from the hospital information management system were adapted to eliminate AST, direct bilirubin, chlorine, fPSA and fT3 tests using five different algorithms defined in the ALIN IQ software.Results: In this study, 18387 AST, 9500 direct bilirubin, 61 free PSA, 1127 FT3 and 11172 chlorine tests that were ordered within 45 days were eliminated using 5 different algorithms defined in the ALIN IQ software in the Laboratory of Harran University Faculty of Medicine. USD 5592.76 was saved in 45 days. The annual saving is expected to be 363710 tests and USD 45363.49.Conclusion: Five different tests were successfully eliminated with this study. Open-code smart softwares, which can create indefinite algorithms may be utilized as test eliminators in diagnostic clinical laboratories. Millions of dollars may be saved by means of such artificial intelligence softwares that can be adapted to any analyzer across the world.

Patient-Based Real-Time Quality Control: Review and Recommendations.

For many years the concept of patient-based quality control (QC) has been discussed and implemented in hematology laboratories; however, the techniques have not been widely implemented in clinical chemistry. This is mainly because of the complexity of this form of QC, as it needs to be optimized for each population and often for each analyte. However, the clear advantages of this form of QC, together with the ongoing realization of the shortcomings of "conventional" QC, have driven a need to provide guidance to laboratories to assist in deploying patient-based QC. This overview describes the components of a patient-based QC system (calculation algorithm, block size, truncation limits, control limits) and the relationship of these to the analyte being controlled. We also discuss the need for patient-based QC system optimization using patient data from the individual testing laboratory to reliably detect systematic errors while ensuring that there are few false alarms. The term patient-based real-time quality control covers many activities that use data from patient samples to detect analytical errors. These activities include the monitoring of patient population parameters such as the mean or median analyte value or using single within-patient changes such as the delta check. In this report, we will restrict the discussion to population-based parameters. This overview is intended to serve as a guide for the implementation of a patient-based QC system. The report does not cover the clinical evaluation of the population.

Should pancreas cyst fluids be divided into two for cytological diagnosis and biochemical tests?

BACKGROUND/AIMS: The aim of the present study was to investigate whether pancreas cyst fluids should be divided into two for cytological diagnosis and biochemical tests. MATERIALS AND METHODS: The present study was conducted with fluids aspirated from 12 pancreas cysts. The fluids were divided into two and sent to the cytopathology (fluid 1) and biochemistry (fluid 2) laboratories. Fluid 1 was centrifuged at the cytopathology laboratory. Cytology slides were prepared from the deposit, and the supernatant was sent to the biochemistry laboratory. Fluid 2 was centrifuged at the biochemistry laboratory, and amylase, carcinoembryonic antigen, and cancer antigen 19.9 levels were determined in the supernatant. These procedures were repeated for fluid 1 from the cytopathology laboratory. The remaining fluid 2 was sent to the cytopathology laboratory. Fluid 1-like slides were prepared from fluid 2 in the cytopathology laboratory. Cytological diagnoses of fluid 1 and fluid 2 were compared, and the Pearson correlation coefficient for biochemical test results was identified. RESULTS: 92% of fluid 1 and 50% of fluid 2 were diagnostic. Biochemical test results of fluid 1 and fluid 2 were similar, and the Pearson correlation coefficient was high. CONCLUSION: Our results showed that pancreatic cyst fluids did not need to be divided into two for cytological diagnosis and biochemical tests. Following centrifugation of the whole fluid at the cytopathology laboratory, the deposit and the supernatant can be used for cytological diagnosis and for biochemical tests, respectively. With this protocol, the sensitivity of cytological diagnoses and biochemical tests of pancreatic cyst fluids may increase.

Variations in biochemical values for common laboratory tests: a comparison among multi-ethnic Israeli women cohort.

BACKGROUND: Biochemical laboratory values are an essential tool in medical diagnosis, treatment, and follow-up; however, they are known to vary between populations. Establishment of ethnicity-adjusted reference values is recommended by health organizations. AIM: To investigate the ethnicity element in biochemical lab values studying women of different ethnic groups. METHODS: Biochemical lab values (n = 27) of 503 adult Israeli women of three ethnicities (Jewish Ashkenazi, Jewish Sephardic, and Bedouin Arab) attending a single medical center were analyzed. Biochemical data were extracted from medical center records. Ethnic differences of laboratory biochemicals were studied using ANCOVA to analyze the center of the distribution as well as quartile regression analysis to analyze the upper and lower limits, both done with an adjustment for age. RESULTS: Significant ethnic differences were found in almost half (n = 12) of the biochemical laboratory tests. Ashkenazi Jews exhibited significantly higher mean values compared to Bedouins in most of the biochemical tests, including albumin, alkaline phosphatase, calcium, cholesterol, cholesterol LDL and HDL, cholesterol LDL calc., folic acid, globulin, and iron saturation, while the Bedouins exhibited the highest mean values in the creatinine and triglycerides. For most of these tests, Sephardic Jews exhibited biochemical mean levels in between the two other groups. Compared to Ashkenazi Jews, Sephardic Jews had a significant shift to lower values in cholesterol LDL. CONCLUSIONS: Ethnic subpopulations have distinct distributions in biochemical laboratory test values, which should be taken into consideration in medical practice enabling precision medicine.

Using Machine Learning to Aid the Interpretation of Urine Steroid Profiles.

BACKGROUND: Urine steroid profiles are used in clinical practice for the diagnosis and monitoring of disorders of steroidogenesis and adrenal pathologies. Machine learning (ML) algorithms are powerful computational tools used extensively for the recognition of patterns in large data sets. Here, we investigated the utility of various ML algorithms for the automated biochemical interpretation of urine steroid profiles to support current clinical practices. METHODS: Data from 4619 urine steroid profiles processed between June 2012 and October 2016 were retrospectively collected. Of these, 1314 profiles were used to train and test various ML classifiers' abilities to differentiate between "No significant abnormality" and "?Abnormal" profiles. Further classifiers were trained and tested for their ability to predict the specific biochemical interpretation of the profiles. RESULTS: The best performing binary classifier could predict the interpretation of No significant abnormality and ?Abnormal profiles with a mean area under the ROC curve of 0.955 (95% CI, 0.949-0.961). In addition, the best performing multiclass classifier could predict the individual abnormal profile interpretation with a mean balanced accuracy of 0.873 (0.865-0.880). CONCLUSIONS: Here we have described the application of ML algorithms to the automated interpretation of urine steroid profiles. This provides a proof-of-concept application of ML algorithms to complex clinical laboratory data that has the potential to improve laboratory efficiency in a setting of limited staff resources.

National survey on turnaround time of clinical biochemistry tests in 738 laboratories in China.

BACKGROUND: This survey was initiated to estimate the current status of turnaround time (TAT) monitoring of clinical biochemistry in China, provide baseline data for establishment of quality specifications and analyze the impact factors of TAT. METHODS: 738 laboratories were included. Questionnaires involved general information and data of related indicators of TAT during 1 week were provided to participating laboratories. Nine quality indicators were covered, which were medians, 90th and outlier rates of pre-examination, examination, and post-examination TAT. The 25th percentile, median, and 75th percentile of TATs were calculated as optimum, desirable, and minimum quality specifications. Percentages and sigma values were used to describe the outlier rates. Mann-Whitney and Kruskal-Wallis tests were used to identify the potential impacts of TAT. RESULTS: Response rate of this survey was 46.44%. More than 50% of the laboratories indicated they had set up target TATs in three time intervals and monitored TATs generally. The post-examination TAT of most laboratories was 0min, while the pre-examination and examination TAT varied. Sigma values of outlier rates for 45%~60% of laboratories were above 4, while 15%~20% of labs whose sigma values were below 3. Group comparisons suggested nurse or mechanical pipeline transportation, link laboratory information system with hospital information system, and using computer reporting instead of printing report were related to shorter TATs. CONCLUSIONS: Despite of the remarkable progresses of TATs in China, there was also room to improve. Laboratories should strengthen the construction of information systems, identify reasons for TAT delay to improve the service quality continuously.

Effect of Procalcitonin Testing on Health-care Utilization and Costs in Critically Ill Patients in the United States.

BACKGROUND: There is a growing use of procalcitonin (PCT) to facilitate the diagnosis and management of severe sepsis. We investigated the impact of one to two PCT determinations on ICU day 1 on health-care utilization and cost in a large research database. METHODS: A retrospective, propensity score-matched multivariable analysis was performed on the Premier Healthcare Database for patients admitted to the ICU with one to two PCT evaluations on day 1 of ICU admission vs patients who did not have PCT testing. RESULTS: A total of 33,569 PCT-managed patients were compared with 98,543 propensity score-matched non-PCT patients. In multivariable regression analysis, PCT utilization was associated with significantly decreased total length of stay (11.6 days [95% CI, 11.4 to 11.7] vs 12.7 days [95% CI, 12.6 to 12.8]; 95% CI for difference, 1 to 1.3; P < .001) and ICU length of stay (5.1 days [95% CI, 5.1 to 5.2] vs 5.3 days [95% CI, 5.3 to 5.4]; 95% CI for difference, 0.1 to 0.3; P < .03), and lower hospital costs ($30,454 [95% CI, 29,968 to 31,033] vs $33,213 [95% CI, 32,964 to 33,556); 95% CI for difference, 2,159 to 3,321; P < .001). There was significantly less total antibiotic exposure (16.2 days [95% CI, 16.1 to 16.5] vs 16.9 days [95% CI, 16.8 to 17.1]; 95% CI for difference, -0.9 to 0.4; P = .006) in PCT-managed patients. Patients in the PCT group were more likely to be discharged to home (44.1% [95% CI, 43.7 to 44.6] vs 41.3% [95% CI, 41 to 41.6]; 95% CI for difference, 2.3 to 3.3; P = .006). Mortality was not different in an analysis including the 96% of patients who had an independent measure of mortality risk available (19.1% [95% CI, 18.7 to 19.4] vs 19.1% [95% CI, 18.9 to 19.3]; 95% CI for difference, -0.5 to 0.4; P = .93). CONCLUSIONS: Use of PCT testing on the first day of ICU admission was associated with significantly lower hospital and ICU lengths of stay, as well as decreased total, ICU, and pharmacy cost of care. Further elucidation of clinical outcomes requires additional data.

Failure to review STAT clinical laboratory requests and its economical impact.

BACKGROUND: Failure to follow-up laboratory test results has been described as one of the major processes contributing to unsafe patient care. Currently, most of the laboratories do not know with certainty not only their rate of missed (or unreviewed) requests but the economical cost and impact that this issue implies. The aim of our study was to measure that rate and calculate the resulting costs. MATERIAL AND METHODS: In January 2015, we checked in our Laboratory Information Management System (LIMS) for every emergency request from 1(st) July 2011 to 30(th) June 2014, if they had been reviewed by any allowed user or not. 319,064 requests were ordered during that period of time. Results were expressed as "ordered requests", "missed requests" and its percentage. Additionally, total cost of missed requests was calculated in euros (€). "Non-productive days" were theorised (as the days producing requests that were not reviewed) based on these results. RESULTS: 7924 requests (2.5%) were never reviewed by clinicians. This represented a total cost of 203,039 € and 27 "non-productive" days in three years. Significant differences between inpatients, outpatients and emergency department as well as different emergencies units were found after application of statistical analysis. CONCLUSIONS: In terms of resources, never reviewed or missed requests appear to be a not negligible problem for the clinical laboratory management. Electronic result delivery, with electronic endorsement to indicate follow-up of requests along with better systems of electronic requesting should be investigated as a way of improving patient outcomes and save unnecessary expenses.

Trends in cardiac biomarker testing in China for patients with acute myocardial infarction, 2001 to 2011: China PEACE-retrospective AMI study.

OBJECTIVES: To describe trends in the availability of biomarker testing in Chinese hospitals and how practice complies with established standards for the diagnosis of acute myocardial infarction (AMI). BACKGROUND: Cardiac biomarker testing is standard in high-income countries, but little is known about the availability and use of cardiac biomarker testing in low- and middle-income countries (LMICs) such as China. METHODS: Based on a nationally representative sample of Chinese hospitals in 2001, 2006 and 2011, we describe the temporal trends and regional differences in the hospital capability and rates of use of cardiac biomarker testing, as well as the variation in use across hospitals with testing capability, for patients labeled with the diagnosis of AMI. RESULTS: We sampled 175 hospitals (162 participated in the study) and 18,631 AMI admissions. 14,370 patients were included in analysis of biomarker use. The proportion of hospitals with biomarker testing capability was 57.4% in 2001 (25.0% troponin and 32.4% creatine kinase MB fraction (CK-MB) only) and 96.3% (81.4% troponin and 14.9% CK-MB only) in 2011. The proportion of hospitals with troponin testing capability in 2011 was significantly higher in urban compared with rural hospitals (96.8% vs. 71.4%, p< 0.001). In 2011, only 55.9% of hospitals with troponin testing capability (71 out of 127 hospitals) used the assay for more than 80% of their patients with AMI. Among hospitals with either biomarker testing capability, there was marked variation in use in both rural (from 7.1% to 100.0% of patients) and urban hospitals (from 57.9% to 100.0% of patients). In 2011, 36.1% of the patients with AMI did not have troponin tested and 4.9% did not have either biomarker measured. CONCLUSIONS: The recommended biomarker tests for AMI diagnosis are not universally available and the testing is not consistently applied when it is available in China. TRIAL REGISTRATION: ClinicalTrials.gov NCT01624883.

Demand management: an audit of chemical pathology test rejections by an electronic gate-keeping system at an academic hospital in Cape Town.

BACKGROUND: Demand management is an area of laboratory activity, which is becoming increasingly important. Within the health-care system, demand management can be defined as the use of health resources to maximise its utility. Tygerberg Hospital has introduced an electronic gate-keeping system. Chemistry tests which generate the highest cost are subjected to this system and may be automatically rejected according to a set of rules. This study aimed: (1) to identify the number of chemistry tests rejected by the eGK; (2) to identify which of these rejected tests were subsequently restored and (3) to assess the impact of rejections on clinical outcome and cost-saving. METHODS: A retrospective audit was conducted to determine the number of chemistry tests rejected and subsequently restored over a 6-month period. The case-notes of patients for whom requested tests previously rejected had been restored were randomly selected and investigated to assess clinical impact. Any cost-saving was calculated. RESULTS: A total of 68,480 tests were subjected to gate-keeping, and 4605 tests (6.7%) were rejected while 679 (14.7%) of these were restored by the requestor phoning the laboratory after obtaining authorisation. After examining a subset of clinical notes it was found that in most cases (80%), patient care was unaffected. The total cost saved was £ 25,387. CONCLUSIONS: The majority of the rejected tests were unnecessary and following rejection, real savings were made. Electronic gate-keeping is a simple, effective and sustainable method of demand management.

The laboratory test utilization management toolbox.

Efficiently managing laboratory test utilization requires both ensuring adequate utilization of needed tests in some patients and discouraging superfluous tests in other patients. After the difficult clinical decision is made to define the patients that do and do not need a test, a wealth of interventions are available to the clinician and laboratorian to help guide appropriate utilization. These interventions are collectively referred to here as the utilization management toolbox. Experience has shown that some tools in the toolbox are weak and other are strong, and that tools are most effective when many are used simultaneously. While the outcomes of utilization management studies are not always as concrete as may be desired, what data is available in the literature indicate that strong utilization management interventions are safe and effective measures to improve patient health and reduce waste in an era of increasing financial pressure.

Pre-analytical errors management in the clinical laboratory: a five-year study.

INTRODUCTION: This study describes quality indicators for the pre-analytical process, grouping errors according to patient risk as critical or major, and assesses their evaluation over a five-year period. MATERIALS AND METHODS: A descriptive study was made of the temporal evolution of quality indicators, with a study population of 751,441 analytical requests made during the period 2007-2011. The Runs Test for randomness was calculated to assess changes in the trend of the series, and the degree of control over the process was estimated by the Six Sigma scale. RESULTS: The overall rate of critical pre-analytical errors was 0.047%, with a Six Sigma value of 4.9. The total rate of sampling errors in the study period was 13.54% (P = 0.003). The highest rates were found for the indicators "haemolysed sample" (8.76%), "urine sample not submitted" (1.66%) and "clotted sample" (1.41%), with Six Sigma values of 3.7, 3.7 and 2.9, respectively. CONCLUSION: The magnitude of pre-analytical errors was accurately valued. While processes that triggered critical errors are well controlled, the results obtained for those regarding specimen collection are borderline unacceptable; this is particularly so for the indicator "haemolysed sample".

The impact of repeat-testing of common chemistry analytes at critical concentrations.

BACKGROUND: Early notification of critical values by the clinical laboratory to the treating physician is a requirement for accreditation and is essential for effective patient management. Many laboratories automatically repeat a critical value before reporting it to prevent possible misdiagnosis. Given today's advanced instrumentation and quality assurance practices, we questioned the validity of this approach. We performed an audit of repeat-testing in our laboratory to assess for significant differences between initial and repeated test results, estimate the delay caused by repeat-testing and to quantify the cost of repeating these assays. METHODS: A retrospective audit of repeat-tests for sodium, potassium, calcium and magnesium in the first quarter of 2013 at Tygerberg Academic Laboratory was conducted. Data on the initial and repeat-test values and the time that they were performed was extracted from our laboratory information system. The Clinical Laboratory Improvement Amendment criteria for allowable error were employed to assess for significant difference between results. RESULTS: A total of 2308 repeated tests were studied. There was no significant difference in 2291 (99.3%) of the samples. The average delay ranged from 35 min for magnesium to 42 min for sodium and calcium. At least 2.9% of laboratory running costs for the analytes was spent on repeating them. CONCLUSIONS: The practice of repeating a critical test result appears unnecessary as it yields similar results, delays notification to the treating clinician and increases laboratory running costs.

Primary care use of laboratory tests in Spain: measurement through appropriateness indicators.

BACKGROUND: To compare the inter-practice and inter-regional variability in laboratory test requests by general practitioners in Spain, through the measure of appropriateness indicators. METHODS: A call for data was posted on the Redconlab website. We obtained production statistics for 2010 from laboratories in 37 different hospitals from diverse Spanish regions. The following appropriateness indicators were calculated: test requests per 1000 inhabitants, ratios of related tests requests and index of variability. The results obtained in the laboratories in the region of authors were compared to the rest of the participating laboratories in order to establish whether there were regional differences in the test requesting patterns. RESULTS: The rate of request of the tests ranged from 31.5 per 1000 inhabitants for vitamin B12 to 372.6 per 1000 inhabitants for glucose. The index of variability ranged from 1.53 for glucose and triglycerides to 7.4 for alkaline phosphatase. Regarding the ratios of related test requests, the variability index ranged from 1.24 for folic acid/vitamin B12 to 26.38 for lactate dehydrogenase/alanine transaminase. The most frequently ordered tests were the ones with less variability, except for uric acid and urinalysis. No significant differences were identified between the results of the laboratories in the region of authors and the rest, except for urinalysis (p < 0.001), folic acid/vitamin B12 (p = 0.030), and transferrin/ferritin (p = 0.018). CONCLUSIONS: A considerable variability exists in laboratory test ordering patterns by general practitioners across Spanish regions. Local habits must have been decisive as shown by the regional differences in the results of indicators of some tests. The study results bring out the need to accomplish interventions to improve appropriate use of laboratory tests.

Electronic health record: design and implementation of a lab test request module.

BACKGROUND: The electronic health record (EHR) has become a fundamental tool in health care. The ordering and inclusion of lab tests and results is one of the most frequently requested services by EHR users. We have designed, developed and implemented in Andalusia, an autonomous community in the south of Spain (8.3 million inhabitants), a unified lab test request module for the Andalusian public health system EHR. PURPOSE: After implementing the module in 27 laboratories, our objective is to assess its impact on healthcare activities and to ascertain whether its functional design addresses the needs and expectations of users. METHODS: We surveyed laboratory and healthcare professionals to assess their opinion of the module's operation in daily practices and the effect it has had on pre- and post-analytical quality indicators (before and after lab test module implementation). RESULTS: All the laboratories surveyed noted that the implementation of the laboratory module in the EHR improved the analytical process, highlighting better safety in patient identification, less programming or container errors and shorter response times. Clinical professionals gave the module a rating of 7.8 out of 10, positively highlighting the speed at which results are delivered and their integration in the EHR. In terms of the model's drawbacks, laboratories have highlighted its rigidity in solving errors and clinical professionals have noted the requirement of adapting to a new nomenclature. It is also necessary to expand coding to all the tests available in clinical laboratories. CONCLUSIONS: The results of our survey indicate that the functional design of our analytical testing module is suitable for user needs, allowing to integrate information from multiple laboratories in a single region. Based on our experience, the key aspects for the success of this project have been: a design conceived for both laboratories and clinical professionals, the involvement of laboratories as a key element of the project, as well as sufficient time of local piloting before widespread implementation which is basic for the success of a computer application that affects so many potential users of the health care system.

Alternative calibration strategies for the clinical laboratory: application to nortriptyline therapeutic drug monitoring.

BACKGROUND: The addition of a calibration curve with every run is both time-consuming and expensive for clinical mass spectrometry assays. We present alternative calibration strategies that eliminate the need for a calibration curve except as required by laboratory regulations. METHODS: We measured serum nortriptyline concentrations prospectively in 68 patients on 16 days over a 2-month period using a method employing calibration schemes that relied on the measurement of the response ratio (RR) corrected by the response factor (RF), i.e., a measurement of the RR for an equimolar mixture of the analyte and internal standard. Measurements were taken with contemporaneous RF (cRF) measurements as well as sporadic RF (sRF) measurements. The measurements with these alternative calibration schemes were compared against the clinical results obtained by interpolation on a calibration curve, and those differences were evaluated for analytical and clinical significance. RESULTS: The differences between the values measured by cRF and sRF calibration and interpolation on a calibration curve were not significant (P = 0.088 and P = 0.091, respectively). Both the cRF- and sRF-based calibration results demonstrated a low mean bias against the calibration curve interpolations of 3.69% (95% CI, -15.8% to 23.2%) and 3.11% (95% CI, -16.4% to 22.6%), respectively. When these results were classified as subtherapeutic, therapeutic, or supratherapeutic, there was categorical agreement in 95.6% of the cRF calibration results and 94.1% of the sRF results. CONCLUSIONS: cRF and sRF calibration in a clinically validated liquid chromatography-tandem mass spectrometry assay yields results that are analytically and clinically commensurate to those produced by interpolation with a calibration curve.