Implementation of patient-based real-time quality control.

The quest to use patient results as quality control for routine clinical chemistry testing has long been driven by issues of the unavailability and cost of suitable quality control material and the matrix effects of synthetic material. Hematology laboratories were early adopters of average of normals techniques, primarily because of the difficulty in acquiring appropriate, stable quality control material, while in the chemistry laboratories, the perceived advantages and availability of synthetic material outweighed the disadvantages. However, the increasing volume of testing in clinical chemistry plus the capability of computer systems to deal with large and complex calculations has now made the use of patient-based quality control algorithms feasible. The desire to use patient-based quality control is also driven by increasing awareness that common quality control rules and frequency of analysis may fail to detect clinically significant assay biases. The non-commutability of quality control material has also become a problem as laboratories seek to harmonize results across regions and indeed globally. This review describes the history of patient-based quality control in clinical chemistry, summarizes the various approaches that can be implemented by laboratory professionals, and discusses how patient-based quality control can be integrated with traditional quality control techniques.

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.

Laboratory intervention to improve the request of urinary albumin in primary care patients with arterial hypertension and financial implications.

INTRODUCTION: The request of Urinary albumin in primary care in Spain is insufficient to monitor patients with diabetes and hypertension (HTN). Our aim was to evaluate a strategy designed in consensus with general practitioners (GPs) to improve the request of urinary albumin in primary care patients with HTN according to guidelines, and to study its financial implications. MATERIALS AND METHODS: In a meeting with GPs, we decided that the Laboratory Information System (LIS) would automatically register the albumin-to-creatinine ratio (ACR) test in patients with HTN when the former had not been requested in the previous year. We counted the number of ACRs requested by the GPs, those that were automatically added through the intervention, and if they were measured through the strip assay or additionally through quantification. We calculated the economic cost of the additional registered ACR based on reagent cost. RESULTS: In the 6 months study period, the laboratory received 48,075 requests for primary care patients. For 3816 (7.9%), HTN was the indication that prompted the request. 386 ACR were automatically registered through the intervention. Use of strip analysis cost of 275.8 € but resulted in savings of 1450.3€ in albumin reagent. CONCLUSIONS: By making use of the laboratory technology, the strategy achieved a better adherence to the guidelines at no additional cost.

A Reflex Protocol for Creatinine Testing Reduces Costs and Maintains Patient Safety.

BACKGROUND: The Jaffe and enzymatic methods are the 2 most common methods for creatinine measurement. The Jaffe method is less expensive but subject to interferences. Some laboratory scientists have called for the Jaffe method to be retired. OBJECTIVE: To determine the most cost-effective and safe protocol for creatinine measurement. METHOD: We performed a retrospective database review of all outpatient creatinine measurements for 1 year, testing the risk-based reflex testing protocol we had implemented for creatinine measurement. Samples were first measured using the Jaffe method and were reflexed to the enzymatic method if the estimated glomerular filtration rate (eGFR) was between 55 and 65 mL per min per 1.73 m2. RESULTS: There were 104,530 creatinine measurements, of which 11,420 (10.9%) were reflexed to the enzymatic method. The Jaffe method had a positive bias of 0.08 mg per dL (-6.14 mL/min/1.73 m2 eGFR). A total of 3.4% of the paired reflexed specimens were discordant. Also, 133 (1.2%) of the Jaffe results were classified as false negatives and 3411 (29.9%) were classified as false positives. None of the false-negative results and 5 of the false-positive results were considered clinically significant. Using the reflex protocol saved approximately $40,000 per year. CONCLUSIONS: The reflex protocol for creatinine measurement can reduce costs with acceptable risk.

The Choosing Wisely initiative and laboratory test stewardship.

The United States Choosing Wisely initiative was started in 2012 by the American Board of Internal Medicine Foundation and focused on reducing medical resource overutilization. Since its inception in the US, similar efforts have arisen in at least a dozen countries. Strongly patient-focused, and in fact started in collaboration with the consumer magazine Consumer Reports, the effort has resulted in a collection of greater than 500 recommendations from over 80 US professional societies intended to inform both patients and doctors about medical practices whose necessity should be questioned or discussed. Targets of recommendations include practices that lack a basis in scientific evidence, practices that may be duplicative of other care already received, practices that may be harmful and practices that are simply unnecessary. While critiques have been levied against the Choosing Wisely initiative over its intent, methods and efficacy, it is clear that many of its recommendations have been adopted by large medical practices, and several positive outcomes, i.e. reductions in perceived waste, have been reported in relation to many of the recommendations, including those specifically targeting laboratory tests. The future success of Choosing Wisely will likely hinge on whether or not significantly positive and durable outcomes can be demonstrated, especially at a time where there is increasing pressure to drive down costs in medical care while concomitantly increasing quality.

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.

Toward High-Value Care: A Quality Improvement Initiative to Reduce Unnecessary Repeat Complete Blood Counts and Basic Metabolic Panels on a Pediatric Hospitalist Service.

OBJECTIVE: Achieving high-value health care is a goal of health care providers who strive to increase quality and decrease cost. Decreasing laboratory tests is a potential method to increase value. We used quality improvement methodology to decrease the percentage of unnecessary complete blood counts (CBCs) and basic metabolic panels (BMPs) obtained on a pediatric hospital medicine service from 13.5% to <5%. METHODS: A pre- and postintervention design was conducted including all patients admitted to 2 hospital medicine teams between May 2013 and December 2014. Multiple interventions linked to key drivers were tested through rapid plan-do-study-act cycles. Primary and secondary outcome measures, percent reduction of unnecessary CBCs and BMPs, and consecutive day tests were analyzed using statistical process control. Total billed charges, laboratory charges, 7-day readmission rates, and length of stay were compared pre- and postintervention. RESULTS: Primary outcome of unnecessary CBCs and BMPs was reduced from a baseline of 13.5% to 4.5%. Secondary outcome measure of consecutive day testing was reduced from 20.9% to 8.5%. Median laboratory charges decreased significantly ($842 [$256-$1863] vs $800 [$222-$1616], P = .002), with no significant differences in total billed charges, 7-day readmission rates, or length of stay. CONCLUSIONS: Rapid cycle plan-do-study-act methodology, initially focusing on the inclusion of a daily laboratory plan in progress notes, was an effective means to improve laboratory utilization and decrease laboratory charges without adversely affecting other quality measures. Spreading these efforts to different patient populations and laboratory tests could have a demonstrable effect on the value of health care.

Total arsenic screening prior to fractionation enhances clinical utility and test utilization in the assessment of arsenic toxicity.

OBJECTIVES: The objective was to evaluate the utility of a screen with reflex-to-fractionation testing compared with direct-to-fractionation testing for suspected toxic exposure. METHODS: This study was based on a retrospective data analysis of urine arsenic results from previously tested samples (n=12,960). Total urine arsenic by inductively coupled plasma mass spectrometry was used as a screening method to identify elevated arsenic concentrations. Arsenic fractionation was the speciation assay to differentiate toxic and benign arsenic species. RESULTS: Screening samples based on total arsenic concentration resulted in less than 10% of samples requiring arsenic fractionation, with a final positivity rate of less than 1% for toxic arsenic. Samples with fractionation ordered directly had a positivity rate for toxic arsenic of 3.3%. The overall positivity rate for exposure to toxic arsenic was less than 1%. CONCLUSIONS: A total arsenic screen before fractionation reduces the number of samples requiring fractionation by more than 91%, supporting the use of a screen with a reflex-to-fractionation approach for urine arsenic.

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.

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.

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.

Managing demand for laboratory tests: a laboratory toolkit.

Healthcare budgets worldwide are facing increasing pressure to reduce costs and improve efficiency, while maintaining quality. Laboratory testing has not escaped this pressure, particularly since pathology investigations cost the National Health Service £2.5 billion per year. Indeed, the Carter Review, a UK Department of Health-commissioned review of pathology services in England, estimated that 20% of this could be saved by improving pathology services, despite an average annual increase of 8%-10% in workload. One area of increasing importance is managing the demands for pathology tests and reducing inappropriate requesting. The Carter Review estimated that 25% of pathology tests were unnecessary, representing a huge potential waste. Certainly, the large variability in levels of requesting between general practitioners suggests that inappropriate requesting is widespread. Unlocking the key to this variation and implementing measures to reduce inappropriate requesting would have major implications for patients and healthcare resources alike. This article reviews the approaches to demand management. Specifically, it aims to (a) define demand management and inappropriate requesting, (b) assess the drivers for demand management, (c) examine the various approaches used, illustrating the potential of electronic requesting and (d) provide a wider context. It will cover issues, such as educational approaches, information technology opportunities and challenges, vetting, duplicate request identification and management, the role of key performance indicators, profile composition and assessment of downstream impact of inappropriate requesting. Currently, many laboratories are exploring demand management using a plethora of disparate approaches. Hence, this review seeks to provide a 'toolkit' with the view to allowing laboratories to develop a standardised demand management strategy.

Preoperative blood tests in elective general surgery: cost and clinical implications.

A retrospective observational study was performed in our trust in October 2010 that examined compliance, and the financial and clinical implications of performing inappropriate preoperative blood tests on adult patients prior to elective surgery, against the 2003 NICE guidelines. An unacceptable proportion of inappropriate tests (31.3%) were being performed. None were associated with adverse outcome or changes in management. Based on our results, we estimate that an extrapolated cost of pound 11.2 million is being spent on inappropriate blood tests in NHS England and Wales.

Utilization of metabolomics to identify serum biomarkers for hepatocellular carcinoma in patients with liver cirrhosis.

Characterizing the metabolic changes pertaining to hepatocellular carcinoma (HCC) in patients with liver cirrhosis is believed to contribute towards early detection, treatment, and understanding of the molecular mechanisms of HCC. In this study, we compare metabolite levels in sera of 78 HCC cases with 184 cirrhotic controls by using ultra performance liquid chromatography coupled with a hybrid quadrupole time-of-flight mass spectrometry (UPLC-QTOF MS). Following data preprocessing, the most relevant ions in distinguishing HCC cases from patients with cirrhosis are selected by parametric and non-parametric statistical methods. Putative metabolite identifications for these ions are obtained through mass-based database search. Verification of the identities of selected metabolites is conducted by comparing their MS/MS fragmentation patterns and retention time with those from authentic compounds. Quantitation of these metabolites is performed in a subset of the serum samples (10 HCC and 10 cirrhosis) using isotope dilution by selected reaction monitoring (SRM) on triple quadrupole linear ion trap (QqQLIT) and triple quadrupole (QqQ) mass spectrometers. The results of this analysis confirm that metabolites involved in sphingolipid metabolism and phospholipid catabolism such as sphingosine-1-phosphate (S-1-P) and lysophosphatidylcholine (lysoPC 17:0) are up-regulated in sera of HCC vs. those with liver cirrhosis. Down-regulated metabolites include those involved in bile acid biosynthesis (specifically cholesterol metabolism) such as glycochenodeoxycholic acid 3-sulfate (3-sulfo-GCDCA), glycocholic acid (GCA), glycodeoxycholic acid (GDCA), taurocholic acid (TCA), and taurochenodeoxycholate (TCDCA). These results provide useful insights into HCC biomarker discovery utilizing metabolomics as an efficient and cost-effective platform. Our work shows that metabolomic profiling is a promising tool to identify candidate metabolic biomarkers for early detection of HCC cases in high risk population of cirrhotic patients.

Troponin testing in the emergency department: a longitudinal study to assess the impact and sustainability of decision support strategies.

AIM: To evaluate the impact of decision support on the proportion of troponin I (cTnI) tests and associated costs over the period 2000-7 for patients presenting with chest pain in an emergency department (ED) setting. METHODS: A longitudinal study using linked data for patients presenting with chest pain from the ED and laboratory information systems of a metropolitan teaching hospital in Melbourne, Australia. The study period was divided into a pre-intervention period (2000-2), which contained no decision support; an initial post period (2003-4) after the introduction of a quality improvement initiative (utilising a paper-based guideline, education, audit and feedback) about cTnI test ordering and the incorporation of the guideline as a decision support feature of the computerised provider order entry system; followed by a post-modification period (2005-7) after the electronic decision support feature was modified to allow clinicians to bypass viewing the complete guideline. RESULTS: There was a significant fall in the proportion of cTnI tests ordered per patient presentation across the three periods-pre (2000-2), post (2003-4) and post-modification (2005-7)-from 7.3% to 4.1% and 2.8%, respectively. Analysis of costs showed significant reductions in the mean costs for cTnI tests per patient presentation from $A9.28 to $A8.54 and $A8.18, respectively, which amounted to a modest saving of $A13,251 since the initiation of decision support in 2003. CONCLUSIONS: Decision support systems are often part of multifaceted implementations undertaken over time. They require continuous monitoring and modifications to ensure optimal performance.

Determination of calcium in synovial fluid samples as an aid to diagnosing osteoarthritis.

BACKGROUND: Microscopic inorganic crystals are commonly observed in the synovial fluid of patients suffering from arthritic diseases. Basic calcium phosphate (BCP) crystals are known to occur quite commonly in the joint fluid of osteoarthritis (OA) patients and are insoluble at physiological pH. Current analysis of patient synovial fluid depends on light microscopy and staining with Alizarin Red-S. Both methods cannot identify crystals < 1µm in size and are highly subjective. This article investigates the use of o-cresolphthalein complexone (OCP), a colorimetric reagent, to quantify calcium from crystals isolated from synovial fluid samples as a means of identifying the presence of BCP and, hence, improving the diagnosis of OA. RESULTS: Inorganic crystals were isolated following degradation of the biological sample matrix with hyaluronidase. 1-M HNO(3) was used for crystal dissociation into ions and the colorimetric response of OCP to calcium was measured in a basic environment of 2-amino-2-methyl-1-propanol. The average calcium content in OA patient samples was up to 40% higher than in rheumatoid arthritis (RA) patient samples. RA samples were used as a comparison, because they are generally accepted to be crystal free. Within the OA group, higher levels of calcium were detected in three out of 12 synovial fluid samples, which correlated with a significantly greater number of BCP crystals detected during microscopic examination. CONCLUSIONS: A simple method based on colorimetry for measurement of calcium content and semiquantification of BCP crystals in synovial fluid samples has been described. Sample pretreatment following addition of hyaluronidase proved to be effective in reducing viscosity and aiding the dissociation of BCP crystals in synovial fluid samples.

Appropriate utilization of clinical laboratory tests.

BACKGROUND: The use of laboratory tests has been increasing in recent years due to various factors affecting laboratories, physicians, legal aspects, or patients themselves. METHODS: The efficacy of laboratory tests must be evaluated on the basis of the clinical benefits that they provide in terms of prevention, diagnosis, follow-up, or treatment; with the aim of optimizing health results in general. RESULTS: There are techniques that can be used to determine the clinical validity of the efficacy, effectiveness, and safety of treatment or preventive measures performed on individuals with abnormal tests, as well as providing an economic evaluation of the process. Once the test is incorporated into clinical service, it must be evaluated by retrospective audits in test utilization. To improve the use of laboratory tests, many strategies have been devised that incorporate clinical practice guidelines (CPGs), the conduct of professionals and the patients, and organization of the process. We discuss the importance of the involvement of health professionals. CONCLUSIONS: Strategies in relation to CPGs, conduct of professionals, conduct of patients, or organization of health care processes improve the use of tests in relation to clinical processes. Laboratory professionals have the appropriate knowledge and can improve the quality and efficacy of health care.