The challenge of COVID-19 for a Clinical Microbiology Department.

OBJECTIVES: To quantify the workload and cost overload that the COVID-19 pandemic has meant for a Clinical Microbiology laboratory in a real-life scenario. METHODS: We compared the number of samples received, their distribution, the human resources, and the budget of a Microbiology laboratory in the COVID pandemic (March-December 2020) with the same months of the previous year. RESULTS: the total number of samples processed in the Clinical Microbiology laboratory in March to December 2020 increased 96.70% with respect to 2019 (from 246,060 to 483,993 samples), reflecting an increment of 127.50% when expressed as samples/1000 admissions (from 6057 to 13,780). The increase in workload was mainly at the expense of the virology (+2058%) and serology (+86%) areas. Despite additional personnel hiring, the samples processed per technician increased 12.5%. The extra cost attributed to Microbiology amounts to 6,616,511 euros (114.8%). CONCLUSIONS: This is the first study to provide quantitative figures about workload and cost increase caused by the COVID-19 in a Microbiology laboratory.

Frequency and Costs of Out-of-Network Bills for Outpatient Laboratory Services Among Privately Insured Patients.

Importance: Patients may be unaware of which laboratory is processing their clinical tests, limiting their ability to choose an in-network laboratory. Out-of-network laboratory services could increase patients' out-of-pocket costs and their reluctance to obtain necessary tests. Objective: To evaluate the frequency and cost of out-of-network bills for outpatient laboratory services compared with other services. Design, Setting, and Participants: This retrospective cohort study of claims data from the Truven MarketScan Commercial Claims database evaluated claims from 3 946 210 individuals (30.5% of the total) in the MarketScan database who were continually enrolled in health maintenance organization plans, preferred provider organization plans, exclusive provider organization plans, or consumer-driven health plans/high-deductible health plans with at least 1 outpatient clinical laboratory service in 2018. Outpatient laboratory services occurred in independent laboratories, physician offices, and outpatient centers. Laboratory bills from January 1, 2010, to December 31, 2018, were studied. Exposures: Receipt and cost of outpatient laboratory service. Main Outcomes and Measures: The primary outcome was the proportion of outpatient laboratory services billed as out of network. The secondary outcome was the total potential out-of-pocket cost associated with the out-of-network bill, the sum of observed cost sharing, and the potential balance bill. Results: Of the 12 958 130 in the total sample, 30.5% (3 946 210) had a laboratory test, of whom 5.9% received an out-of-network laboratory test. In comparison, 7.1% of the total sample had an emergency department visit, of whom 4.9% had a service billed as out of network, and 1.6% had an inpatient anesthesiology service, of whom 3.4% had an out-of-network service. Observed out-of-pocket spending was $24.59 higher for an out-of-network laboratory service than an in-network laboratory service. In addition, patients with an out-of-network laboratory service may receive an additional balance bill from the laboratory service; the estimated mean balance bill was $80.63. For the most common laboratory services, the total potential out-of-pocket cost associated with an out-of-network bill ranged from $15.68 for venipuncture to $88.09 for lipid panel but was as high as $303.18 for a drug screening test. Conclusions and Relevance: In this cohort study, out-of-network laboratory services were 5 times more common than out-of-network emergency department visits and 34 times more common than out-of-network anesthesiology services. It is important for patients that consumer protections against out-of-network bills apply to laboratory services.

[Health policy experiences of publicly financed laboratory services in Hungary with health insurance data analysis]. / A közfinanszírozott laboratóriumi szolgáltatások egészségpolitikai tapasztalatai Magyarországon egészségbiztosítási adatok elemzésével.

Introduction: In order to provide appropriate prevention, diagnosztics, decision on therapy and monitoring the results of medical treatment, there is an increasing need for laboratory examinations. Aim: The aim of our study is the health-ecnomics analysis of laboratory budget of the Hungarian Health Insurance Fund. Data and method: Data were derived from the financial database of the National Health Insurance Fund Administration. The analysis covered the period of 2002-2018. We analysed the annual budget for laboratory examinations, the number of patients and examinations, the market share of laboratory services providers according to their owner structure from the health insurance curative-preventive budget. Results: The budget available for financing the laboratory examinations (21-22 billion Hungarian forint (Ft)/év) did not change significantly between 2005 and 2015. There was a significant decrease in the number of both patients and examinations between 2006 and 2008. In the latest years, there were 14-15 million cases per year and 180 million examinations per year. The market share of for-profit companies decreased from 29.0% in 2010 to 10.6% in 2018, while the market share of governmental institutions increased from 27.1% in 2010 to 78.7% in 2018. Conclusion: The activity of laboratories was stabilized in the latest years. After the necessary correction of professional regulations and code maintenance, the laboratory budget can be increased towards the mainly public laboratory services providers. Orv Hetil. 2020; 161(12): 468-473.

Addition of Efficiency Measures to Current Accuracy Measures in the Vascular Laboratory Can Be Used for Future Accreditation and Payment Models.

BACKGROUND: The Medicare Access and CHIP Reauthorization Act (MACRA) brings with it increased regulatory requirements not traditionally addressed by standard vascular laboratory accreditation, which is based on accuracy. The new quality improvement project of the Intersocietal Accreditation Commission (IAC) may satisfy an improvement activity (IA) of the MACRA. We hypothesize that other IAs in the MACRA such as timeliness of test results or patient care quality performance requirements can be met by analyzing data already being collected by the vascular laboratory. After a process improvement strategy, we chose to review progress in our vascular laboratory related to time to interpretation (TI), patient check-in to study completion (study time), wait time for first available outpatient venous duplex scan (wait time), technologist productivity, and critical results reporting. METHODS: Data from our hospital-based vascular laboratory were collected from 2010 to 2016. TI was collected through our reporting software VascuPro (Consensus Medical), and study time and wait time were obtained from electronic medical records (EMR) (Epic). Technologist productivity was calculated by commercially available productivity tools, and compliance with critical results reporting was calculated quarterly as per our quality assurance program. Appropriateness of carotid duplex scan testing was performed by expert review of International Classification of Disease codes used to request the test. RESULTS: TI analysis comprised 91,352 studies with a mean of 3.3 hr between test completion and final interpretation. The TI improved from 5.0 to 2.1 hr on weekdays and was longer on weekends (4.9 hr; P < 0.001). The study time improved from 29.8 to 27.2 min and was 14.9 min shorter on the weekends (P < 0.001). The wait time ranged from a mean of 1-2.08 days. Technologist productivity improved from 90.7% to 93.6%. Critical results reporting quarterly audits showed a 100% compliance rate. On expert review, the International Classification of Disease code on carotid duplex scan requests in the EMR was deemed inaccurate in 17.4% of cases. CONCLUSIONS: TI and study time improved; wait time and critical results reporting remained steady. Most of the data are readily available in a vascular laboratory standard EMR. The plan-do-study-act (PDSA or Shewhart Cycle) principle is critical to process improvement and needed as we transition from traditional accreditation mostly based on test accuracy to one demanding efficiency, timeliness, patient satisfaction, productivity, accountability, and appropriateness of testing. Process improvement studies will improve patient care and satisfaction, increase efficiency and throughput, while satisfying changing IAC standards and preparing for upcoming regulatory requirements of the MACRA.

The economic efficiency of clinical laboratories in public hospitals: A case study in Iran.

INTRODUCTION: Clinical laboratories are identified as one of the most important and expensive units of the health system. Therefore, it is essential to pay attention to these units' cost efficiency. This study purpose was to evaluate the economic efficiency of hospitals' laboratory units affiliated to Urmia University of Medical Sciences (UMSU), in order to assess their performance. METHODS: This research was a descriptive-analytic study that was accomplished in 2017. The statistical population of the study included all of the hospitals' clinical laboratories affiliated to UMSU. Moreover, DEA method and Deap2.1 software were used to analyze data. In this study, technical and allocative efficiencies of the studied laboratory units were also calculated in addition to the determination of the economic efficiency of the laboratories. RESULTS: The average economic efficiency of clinical laboratories calculated by DEA in 2017 was 0.676. This value was lower than the allocative and technical efficiency scores, which indicates that these units could attain full efficiency by reducing their costs without having any effect on output values. Moreover, about 14 percent of the clinical laboratory units were economically efficient. In addition, it is noteworthy to state that, from total of university hospital laboratories, only three hospitals had no economic excess or deficiency values of inputs. CONCLUSION: Considering that 76% of laboratory units have not been economically efficient, it is necessary for the laboratory managers to consider optimum allocating of resources, with respect to the cost of laboratory equipment and inputs in order to increase their units' economic efficiency.

Impact of implementation of an enhanced recovery program in gynecologic surgery on healthcare costs.

BACKGROUND: Enhanced recovery programs have been associated with improved outcomes after gynecologic surgery. There are limited data on the effect of enhanced recovery programs on healthcare costs or healthcare service use. OBJECTIVE: The purpose of this study was to evaluate differences in hospital charges for women who undergo surgery for a suspected gynecologic cancer that is managed in an enhanced recovery program as compared with conventional perioperative care. STUDY DESIGN: We performed a retrospective cohort study of women who underwent open abdominal surgery for a suspected gynecologic cancer before and after the implementation of an enhanced recovery after surgery program. Consecutive patients from May to October 2014 and from November 2014 to November 2015 comprised the conventional perioperative care (before enhanced recovery after surgery) and enhanced recovery after surgery cohorts, respectively. Patients were excluded if they underwent surgery with a multidisciplinary surgical team or minimally invasive surgery. All technical and professional charges were ascertained for all healthcare services from the day of surgery until postoperative day 30. Charges for adjuvant treatment were excluded. Charges were classified according to the type of clinical service provided. The primary outcome was the difference in total hospital charges between the pre-enhanced recovery after surgery and the enhanced recovery after surgery groups. Secondary outcomes were between group differences in hospital charges within clinical service categories. RESULTS: A total of 271 patients were included in the analysis (58 patients in the pre-enhanced recovery after surgery and 213 patients in the enhanced recovery after surgery cohort). A total of 70,177 technical charges and 6775 professional charges were identified and classified. The median hospital charge for a patient decreased 15.6% in the enhanced recovery after surgery group compared with the pre-enhanced recovery after surgery group (95% confidence interval, 5-24.5%; P=.008). Patients in the enhanced recovery after surgery group also had lower charges for laboratory services (20% lower; 95% confidence interval, 0--39%; P=.04), pharmacy services (30% lower; 95% confidence interval, 14--41%; P<.001), room and board (25% lower; 95% confidence interval, 20--47%; P=.005), and material goods (64% lower; 95% confidence interval, 44--81%; P<.001). No differences in charges were observed for perioperative services, diagnostic procedures, emergency department care, transfusion-related services, interventional radiology procedures, physical/occupational therapy, outpatient care, or other services. CONCLUSION: Hospital charges and healthcare service use were lower for enhanced recovery patients compared with patients who received conventional perioperative care after open surgery for a suspected gynecologic cancer. Enhanced recovery programs may be considered to be high value in healthcare because they provide improved outcomes while lowering resource use.

Utilization of Laboratory Testing Algorithms for Celiac Disease in a Pediatric Hospital.

BACKGROUND: At Texas Children's Hospital in Houston, numerous celiac tests are ordered from a wide range of nonspecialty healthcare providers. OBJECTIVE: To retrospectively examine the ordering of celiac tests before and after a test ordering initiative at our institution, to determine whether the initiative impacted appropriate usage of those tests and affected costs. METHODS: We carefully scrutinized all orders for comprehensive celiac testing from July 2016 through September 2017, implemented an in-house celiac-disease screening cascade, and reflexed it to the comprehensive celiac testing panel if an abnormal screening result was obtained. RESULTS: A total of 60 celiac test orders were issued during the 14-month study period. The ordering physician was a gastroenterologist in 6 cases and a nongastroenterologist in 54 cases. Of the 60 orders, only 4 were approved for sending out for comprehensive celiac testing; in 52 of the 60 cases, the order was altered to celiac screening. In the remaining 4 cases, the tests were canceled as a result of incorrect orders. Only 1 of the 52 celiac screenings yielded a positive result and thus was reflexed to the comprehensive panel. CONCLUSIONS: We were able to induce appropriate celiac test usage by implementing a celiac-reflexive cascade. Also, our strategy proved to be extremely cost effective.

Teaching Laboratory Stewardship in the Medical Student Core Clerkships Pathology-Teaches.

CONTEXT.­: Current health care spending is unsustainable, and there is a need to teach high-value care principles to future physicians. Pathology-Teaches is an educational intervention designed to teach laboratory stewardship early in clinical training, at the level of the medical student in their core clinical clerkships. OBJECTIVE.­: To assess the pilot implementation of case-based educational modules in 5 required core clerkships at our institution. DESIGN.­: The online cases were developed by using a multidisciplinary approach. In the Pathology-Teaches educational module, students make decisions regarding the ordering or interpretation of laboratory testing within the context of a clinical scenario and receive immediate feedback during the case. The intervention was assessed by using pretest and posttest. Student feedback was also collected from end-of-rotation evaluations. RESULTS.­: A total of 203 students completed the Pathology-Teaches pilot, including 72 in Family Medicine, 72 in Emergency Medicine, 24 in Internal Medicine, 24 in Neurology, and 11 in Obstetrics-Gynecology (OB-GYN). Pathology-Teaches utility was demonstrated by significantly increased improvement between pretest and posttest scores (mean, 63.1% versus 83.5%; P < .001; Hedge g effect size = 0.93). Of the 494 students who completed the Pathology-Teaches questions on the end-of-rotation evaluation, 251 provided specific feedback, with 38.6% (97 of 251) rating the activity as "extremely valuable" or "very valuable," and 41.4% (104 of 251) as "some/moderate value." Qualitative feedback included 17 positive comments with 6 requests to scale up or include more cases, 16 constructive comments for improvement mainly regarding the technical aspects, and 5 negative comments. CONCLUSIONS.­: Pathology-Teaches effectively teaches stewardship concepts, and most students perceived value in this educational intervention.

Advances in Rapid Molecular Blood Culture Diagnostics: Healthcare Impact, Laboratory Implications, and Multiplex Technologies.

BACKGROUND: For far too long, the diagnosis of bloodstream infections has relied on time-consuming blood cultures coupled with traditional organism identification and susceptibility testing. Technologies to define the culprit in bloodstream infections have gained sophistication in recent years, notably by application of molecular methods. CONTENT: In this review, we summarize the tests available to clinical laboratories for molecular rapid identification and resistance marker detection in blood culture bottles that have flagged positive. We explore the cost-benefit ratio of such assays, covering aspects that include performance characteristics, effect on patient care, and relevance to antibiotic stewardship initiatives. SUMMARY: Rapid blood culture diagnostics represent an advance in the care of patients with bloodstream infections, particularly those infected with resistant organisms. These diagnostics are relatively easy to implement and appear to have a positive cost-benefit balance, particularly when fully incorporated into a hospital's antimicrobial stewardship program.

Rapid Diagnostics for Blood Cultures: Supporting Decisions for Antimicrobial Therapy and Value-Based Care.

Bacteremia and sepsis are critically important syndromes with high mortality, morbidity, and associated costs. Bloodstream infections and sepsis are among the top causes of mortality in the US, with >600 deaths each day. Most septic patients can be found in emergency medicine departments or critical care units, settings in which rapid administration of targeted antibiotic therapy can reduce mortality. Unfortunately, routine blood cultures are not rapid enough to aid in the decision of therapeutic intervention at the onset of bacteremia. As a result, empiric, broad-spectrum treatment is common-a costly approach that may fail to target the correct microbe effectively, may inadvertently harm patients via antimicrobial toxicity, and may contribute to the evolution of drug-resistant microbes. To overcome these challenges, laboratorians must understand the complexity of diagnosing and treating septic patients, focus on creating algorithms that rapidly support decisions for targeted antibiotic therapy, and synergize with existing emergency department and critical care clinical practices put forth in the Surviving Sepsis Guidelines.

The cost of repetitive laboratory testing for chronic disease.

Interval laboratory investigations are necessary for monitoring chronic diseases. However, testing too frequently may not be beneficial clinically and can be considered low-value care. We examined the frequency of glycosylated haemoglobin, lipids, iron panels (serum iron, ferritin, transferrin, iron binding) thyroid function (free T4 and thyroid stimulating hormone) and 25-OH vitamin D tests in a 1290-bed tertiary hospital in Singapore. All tests done over a 20-month period (January 2016 to August 2017) were retrieved from the laboratory database. Of the 275 565 tests done for 115 971 patients, 5.2% were repeat tests done at intervals shorter than the minimum retesting interval, as defined by the Royal College of Pathologist and Irish Guidelines on the Use of the Laboratory. Using the Centers for Medicare and Medicaid Services Clinical Laboratory Fee Schedule, we estimated a cost burden of US$222 096 per year. Strategies to reduce unnecessary repetitive testing can result in significant cost savings.

[Assessment for antihypertensive drug intake: How, where and when?] / Pourquoi, comment et où dose-t-on les antihypertenseurs en 2019 ?

AIM: Hypertension is a public health problem managed according to therapeutic strategies published in France by the Hauteautoritéde santé (HAS - French Health Authorities). For patients with resistant hypertension, related or not to a non-adherence, prescribers need to be sure the exposure is high enough to achieve the tensional target. Quantitative analysis of antihypertensive drugs in different biological matrices (blood/urine) is one possible solution. However, this involves determining the concentrations observed at standard doses and knowing how to interpret the measured concentrations. It is also necessary to identify medical laboratories that can assay antihypertensive drugs. This was the aim of our work. METHODS: The main antihypertensive drugs recommended by the HAS have been listed. For each of them, we looked for published steady-state plasma/serum concentrations and quantities excreted in the urine at usual dosages. In addition, the elimination half-life and linear pharmacokinetic profile were specified for each antihypertensive agent measured in plasma/serum. Pharmacology-Toxicology laboratories in France likely to carry out assays were identified. The time taken to report the result and the cost of the analysis were also specified. RESULTS: All of the afore-mentioned information has been collected and presented in a table. This can then be used to compare the plasma/serum concentration or the quantity measured in a patient's urine with the values reported in the literature. In cases where the blood sampling times differ between those of the patient and the published data, the patient's measured value is compared to the estimated value based on the published concentrations and pharmacokinetics. CONCLUSION: Interpretation of the plasma/serum/urinary value measured or estimated for an antihypertensive drug is a particularly interesting approach to determine if drug exposure is enough and a possible non-adherence. However, this activity is mostly carried out in hospital centres.

Prevalence and associated factors of inappropriate repeat test.

BACKGROUND: The rate of laboratory test utilisation has been increasing unsustainably. Evaluating inappropriately repeated laboratory tests is promising because objective criteria are available to measure the rates while causes can be manipulated easily. In this study, we aimed to evaluate the prevalence, associated factors and financial burden of inappropriate repeat tests. METHODS: A cross-sectional study was conducted on the results of 26 types of laboratory tests recorded in a laboratory database of a tertiary hospital between 1 July 2014 and 30 June 2017. Minimum retest intervals were determined from the literature for each type of tests. If the time interval between the two tests was shorter than the minimum retest interval, then the later test was accepted an inappropriate repeat test. Binary logistic regression was performed after univariate analyses. RESULTS: Of a total of 673 794 tests, 109 370 (16.2%) were inappropriate repeat tests. Male gender, being ≥65 years old, being an inpatient, high-volume test and surgical clinic as the test-requesting clinic were associated with inappropriate repeat tests. Also, it was determined that US$66 761.3 had been wasted on inappropriate repeat tests for 3 years. DISCUSSION: There are several factors that increase the rate of inappropriate repeat tests. They should be considered during health policy making or planning interventions to reduce inappropriate repeat tests.

[Patient-initiated diagnostics - a challenge for laboratory medicine]. / Egenordinerad provtagning kan ge laboratoriemedicinen ny roll.

Citizens can now order their own laboratory investigations. Self-testing is in line with increasing patient empowerment and in conflict with existing routines in medicine where all tests are ordered by the physician. Several challenges have to be faced by laboratory medicine to secure the quality and increase the medical benefits of patient-initiated diagnostics.

Estimating the cost of quality of errors in the analytical phase.

BACKGROUND: Cost of quality (COQ) can be defined as the difference between the current cost of providing laboratory services and the cost that would be incurred if there were no errors in the measurement process. Errors due to analytical imprecision and bias are not traditionally included in COQ. The objective of this study was to develop methods to estimate the COQ due to errors in the analytical phase. METHODS: We consider 2 types of error events: errors in patient results and run failures due to violation of a quality control (QC) rule. We provide a general and a simplified model for estimating the cost of analytical errors in patient results and a separate model for estimating costs due to QC failures. RESULTS: An example calculation is provided. The COQ for 12 mass spectrometry assays using the simplified cost model for estimating analytical errors and the cost model for run failures is presented. CONCLUSIONS: The models provide a way to estimate COQ associated with analytical error, which have not been previously incorporated into clinical laboratory standards or published literature. Estimating COQ and using those data to prioritize improvement efforts can be challenging for laboratories but are important for value-driven patient care.