Appropriate Use Of Laboratory Tests Research Articles

Long-term alliance for pathology equipment and technology acquisition: a paradigm shift for improved quality and efficiency.

Personnel costs are the largest single budget item in the clinical laboratory, other major expenses being equipment, analyzers, blood and blood components, and cost of day-to-day consumables. This report describes our experience with developing a long-term relationship with a single major vendor as a paradigm shift from the traditional multiple vendors, multiple contracts, and recurrent extended negotiations. Our objective was to develop a long-term approach for replacement of effete equipment and upgrades to operations in a pathology and laboratory medicine department in collaboration with vendors providing equipment and services. Major vendors were invited to visit the department to analyze the workload and workflow and suggest integrated solutions to meet the goals of the department. Multiple iterations of the proposals were evaluated, and a recommendation made to the medical center leadership. The vendor, the medical center, and the department jointly developed a 15-year partnership plan to improve the operations of pathology services. The agreement encompasses a range of management and performance criteria for both sides. The salient items discussed were laboratory staffing, turnaround time, workload change, test insourcing, reference laboratory costs, and scholarly productivity and teaching. The agreement reduced laboratory staffing by 21%, eliminated stat tests by reducing the turnaround time for routine tests to less than 45 minutes for 90% of tests, with an increase of 9.1% in the number of tests, Cost avoidance in salary and reference laboratory costs was $3,424,136/year against an expected target of $2 million in total savings, despite not including cost avoidance from promoting appropriate use of laboratory testing for inpatients and increase in revenue from increase in ambulatory testing. Vizient score in laboratory utilization improved from the 94th to 76th percentile. Scholarly output increased by more than 100%. This model of a long-term alliance with a chosen vendor led to improvements in quality and efficiency.

FDA Regulation of Laboratory Clinical Decision Support Software: Is It a Medical Device?

On September 28, 2022, the Food & Drug Administration (FDA) released its guidance for clinical decision support (CDS) software (1), in which it outlines the criteria by which the FDA will determine whether a commercial CDS software will be regulated as a medical device (similar to a laboratory testing device) or be declared a “non-device” with lower regulatory burden. This distinction will impact the growing discipline of computerized CDS applied to laboratory testing, and it is critical for laboratory medicine professionals to be aware of and adapt to this rapidly changing field. CDS can be defined as “the use of information and communication technologies to bring relevant knowledge to bear on the healthcare and well-being of a patient” (2). CDS filters and organizes patient-specific data and presents it to caregivers to guide decisions regarding a patient’s health (3). CDS interventions have found increasing use in laboratory medicine, both to foster appropriate use of laboratory testing as well as to improve healthcare decisions based on test results (4, 5). Examples include avoiding order errors (6), preventing duplicate testing (7), and predicting outcomes or disease states using available test results (8–10).

Positive Rate of Tests for Group a Streptococcus and Viral Features in Children with Acute Pharyngitis.

Group A streptococcus (GAS) is an important cause of acute pharyngitis. We investigated the positive rate of GAS tests and clinical viral features in children with acute pharyngitis. A retrospective review was conducted for patients <15 years old with both rapid antigen detection test (RADT) and throat culture results. Patients were excluded if they were diagnosed with influenza or had received antibiotics within two weeks before these tests. A total of 377 patients were eligible. The median age of patients was 3.5 years, and 45.4% of total patients were <3 years old. Among all patients, 68.7% had at least one viral feature, and 39% had more than two. The overall positiv rate for GAS was 11.4%. The GAS positive rate was significantly lower in patients <3 years old than in older patients (1.8% vs. 19.4%, p < 0.0001). The overall sensitivity and specificity of RADT were 75.0% (95% CI: 57.8–87.9) and 97.9% (95% CI: 95.8–99.2), respectively. The GAS positive rate was not significantly different between patients with and without viral features (12.4% vs. 9.3%, p = 0.4854). In patients aged 3–14 years, the GAS positive rate was not associated with the modified Centor score or the frequency of clinical viral features. Despite a low prevalence of GAS pharyngitis, testing for GAS was frequently performed in children <3 years old in this study. Appropriate use of laboratory testing for GAS pharyngitis and judicious prescription of antibiotics were imperative.

The clinical laboratory: a decision maker hub.

We aimed to share a new laboratory model based on laboratory knowledge, meaningful use of information technology, and partnership with clinicians, to lead the appropriate use of laboratory testing and clinical decision making in the diagnosis of as-yet-undiagnosed disease. More specifically, we evaluate the role of eight different opportunistic interventions to diagnose certain asymptomatic disorders, by means of the automatic registration of appropriate laboratory testing according to different scenarios. This is a retrospective longitudinal study to evaluate the impact of laboratory interventions on the diagnosis of different diseases and on patient care, including data from January 2012 to September 2020. Overall, the above strategies have so far identified 2063 patients with clinically relevant as-yet-undiagnosed disorders who would have otherwise remained occult, suchas for instance, primary hyperparathyroidism, diabetes, and hypomagnesemia. We are facing a new laboratory model, a leading laboratory rather than a passive traditional laboratory, not just to intervene in clinical decision-making, but to make the clinical decision, through the identification of patients with occult disease.

Development and implementation of a clinician report to reduce unnecessary urine drug screen testing in the ED: a quality improvement initiative

BackgroundUnnecessary testing is a problem-facing healthcare systems around the world striving to achieve sustainable care. Despite knowing this problem exists, clinicians continue to order tests that do not contribute to...

Appropriate Clinical Use of Lactate Measurements.

Elevated lactate can result from many pathophysiologic processes. Understanding the mechanism of lactate production, metabolism, and the basics of lactic acidosis will enable the appropriate use of laboratory tests and interpretation.

Modelling drugs interaction in treatment-experienced patients on antiretroviral therapy

Understanding pharmacology and drug resistance patterns plus appropriate use of laboratory testing is vital for managing treatment-experienced patients with new agents. While we acknowledge that patients with extensive drug resistance now have multiple options for suppressive therapy, and expert care is essential to avoid the rapid emergence of resistance to these new agents, clinicians are unaware of the inherent (hidden) patterns created by combined drug regimens that could trigger adverse drug reactions. This paper proposes a novel hybrid system framework that combines soft computing techniques, for drugs interaction modelling and precise patient response optimisation. A Fuzzy Logic system was developed to address the uncertainty in treatment change episodes (TCEs). A weighted least-squares cost function was then employed to auto-tune hyperparameters for training the neural network. After acceptable tuning, the final hyperparameters served the neural network—to efficiently learn the ensuing patterns for precice drug interaction classification. The proposed framework was experimented with clinical data of TCEs from two disparate sources: a publicly available HIV database (the Stanford HIV database: https://hivdb.stanford.edu ), and clinical data collected from 13 health centers managing HIV cases in Akwa Ibom State of Nigeria (the Akwa-Ibom HIV database). In both databases, a correlation of prognostic markers suggests strong association between first line CD4 and follow-up CD4 counts; while a moderately weak association was observed for first line and follow-up viral loads. Correlation of physiological feature gave very strong association between first line and follow-up body mass index in Akwa-Ibom database. Analysis of the patients progress explains the decreased potency of CD4 count and body mass index as HIV predictors. The root mean square error (RMSE) and classification accuracy were used as performance metrics for measuring the precision of our hybrid framework. Results obtained showed improved RMSE and classification accuracy for both databases, when compared with existing works.

Knowledge of Laboratory Medicine in Medical Students: Is It Sufficient?

Background & Objective:Appropriate use of laboratory testing is essential for achieving safe and effective care to patient. Insufficient knowledge could lead to poor case management and increase the health care costs. It is believed that education on laboratory testing for undergraduate medical student is inadequate. This study was designed to evaluate the level of knowledge of 5 and 6 year undergraduate medical students in field of laboratory medicine.Methods:Totally, 59 questions including 8 basic questions concerning individual assessment of their knowledge and 51 objective questions focusing on various stages of test ordering and interpretation were asked.Results:Thirty seven undergraduate medical students at the level of internship participated. On average, 47.9% of students evaluated themselves as “weak" in 8 self-assessment questions. There was no significant difference between responders assessment on their own knowledge in various aspects of laboratory testing (P=0.184). In the objective questions regarding various stages of test ordering including pre-analytic, analytic and post analytic phases,45.6%,51.9% and 50% correct answers were reported ,respectively. Comparison of the level of the knowledge of the students regarding various stages of pathology testing did not show significant difference (P=0.638).Conclusion:Prioritizing an effective teaching method of laboratory medicine to medical students on appropriate time should be considered in medical school curriculum for better clinical decision making and optimal modern medical care.

Mumps: an Update on Outbreaks, Vaccine Efficacy, and Genomic Diversity.

Mumps is an acute viral infection characterized by inflammation of the parotid and other salivary glands. Persons with mumps are infectious from 2 days before through 5 days after parotitis onset, and transmission is through respiratory droplets. Despite the success of mumps vaccination programs in the United States and parts of Europe, a recent increase in outbreaks of mumps virus infections among fully vaccinated populations has been reported. Although the effectiveness of the mumps virus component of the measles-mumps-rubella (MMR) vaccine is suboptimal, a range of contributing factors has led to these outbreaks occurring in high-vaccination-coverage settings, including the intensity of exposure, the possibility of vaccine strain mismatch, delayed implementation of control measures due to the timeliness of reporting, a lack of use of appropriate laboratory tests (such as reverse transcription-PCR), and time since last vaccination. The resurgence of mumps virus infections among previously vaccinated individuals over the past decade has prompted discussions about new strategies to mitigate the risk of future outbreaks. The decision to implement a third dose of the MMR vaccine in response to an outbreak should be considered in discussions with local public health agencies. Traditional public health measures, including the isolation of infectious persons, timely contact tracing, and effective communication and awareness education for the public and medical community, should remain key interventions for outbreak control. Maintaining high mumps vaccination coverage remains key to U.S. and global efforts to reduce disease incidence and rates of complications.

Clinicians' and laboratory medicine specialists' views on laboratory demand management: a survey in nine European countries.

Laboratory tests are an essential aspect of current medical practice and their use has grown exponentially. Several studies however have demonstrated inappropriate use of laboratory testing. This inappropriateness can lead to delayed or wrong diagnosis, negatively impacting patient safety and an increase in health care expenditure. The aim of the present small-scale survey was to obtain information on the current status of demand management in European laboratories, as well as the opinions of laboratory and clinical professionals in this regard. Two surveys were developed, one for laboratory specialists and one for clinicians, covering information on current use, knowledge and opinions on the possible impact of different demand management strategies on patient outcome and health care costs. Additionally, we asked for the current state and willingness on collaboration of laboratory specialists and clinicians. One hundred and fifty responses, 72 laboratory specialists and 78 clinicians, from nine countries were received. Developing local ordering protocols/profiles in collaboration with clinicians was the most used strategy (80.3% of laboratories). Of clinicians, 85.6% considered measures to ensure appropriate use of tests necessary and 100% were interested in advice/information about their indication. Of the laboratory specialists 97.2% were either already participating or willing to participate in multidisciplinary groups on the appropriateness of test demand as were 60.3% of clinicians, and 85.9% of clinicians were interested in attending activities about laboratory test demand management. The results of our survey show that tools to improve the appropriate use of laboratory tests are already regularly used today. Laboratory medicine specialists as well as clinicians are willing to undertake additional shared activities aimed at improving patient-centered laboratory diagnostic workup.

Microbiological Laboratory Testing in the Diagnosis of Fungal Infections in Pulmonary and Critical Care Practice. An Official American Thoracic Society Clinical Practice Guideline.

Background: Fungal infections are of increasing incidence and importance in immunocompromised and immunocompetent patients. Timely diagnosis relies on appropriate use of laboratory testing in susceptible patients.Methods: The relevant literature related to diagnosis of invasive pulmonary aspergillosis, invasive candidiasis, and the common endemic mycoses was systematically reviewed. Meta-analysis was performed when appropriate. Recommendations were developed using the Grading of Recommendations Assessment, Development, and Evaluation approach.Results: This guideline includes specific recommendations on the use of galactomannan testing in serum and BAL and for the diagnosis of invasive pulmonary aspergillosis, the role of PCR in the diagnosis of invasive pulmonary aspergillosis, the role of β-d-glucan assays in the diagnosis of invasive candidiasis, and the application of serology and antigen testing in the diagnosis of the endemic mycoses.Conclusions: Rapid, accurate diagnosis of fungal infections relies on appropriate application of laboratory testing, including antigen testing, serological testing, and PCR-based assays.

The sustainable impact of an educational approach to improve the appropriateness of laboratory test orders in the ICU.

IntroductionFew studies described strategies to improve the use of diagnostic tests in intensive care units (ICU). No study assessed whether their impact was sustained or not. In this study, we assessed whether a multi-faceted intervention for more appropriate use of laboratory testing can decrease the number of tests, is sustainable, is not associated with additional morbidity and represents a potential cost saving.Material and methodsAn open-label prospective cohort study in two separated units of the same medical intensive care unit (ICU) including respectively 3315 and 2392 consecutive patients. After the observation period (2010), a reduction in ICU A of unnecessary diagnostics tests as part of a program including senior supervisory of juniors’ orders, encouragements for orders containment at each everyday round discussions (period 2; 2011). Period 3 (2012) consisted in the prolongation of the protocol as a routine care without supervision; Period 4 (2013) was a new period of observation without intervention. No modification was implemented in ICU B in periods 2–4.ResultsAfter the intervention, a decrease in the overall number of tests per ICU-patient-days (37.3±5.5 (baseline) to 15.2±3.2 (- 59%); p<0.0001) was observed. The total cost of the tests decreased from 239±41 to 104±28 euros per ICU-patient days; p<0.0001. The effect on laboratory test orders was sustainable in period 3 (-49%) and 4 (-30%). No significant secondary effect of the intervention was observed in period 2. In ICU B, there was no significant change in the overall laboratory test orders in between the periods.ConclusionsLaboratory test containment is effective, likely safe and sustainable provided that an educational program is repeatedly promoted, that it makes sense for the whole team, that senior and junior physicians are both committed in the program, and that encouragements for laboratory orders containment at each everyday round discussions.

Diagnostic Stewardship: Opportunity for a Laboratory-Infectious Diseases Partnership.

Recent advances in microbial diagnostics are providing clinicians with information about microbes causing infections and their resistance to antimicrobial agents more rapidly than ever before. Diagnostic stewardship refers to the appropriate use of laboratory testing to guide patient management, including treatment, in order to optimize clinical outcomes and limit the spread of antimicrobial resistance. Fulfilling the promise of diagnostic stewardship requires a seamless partnership between clinical laboratories, pharmacists, and infectious diseases clinicians, so that appropriate tests are ordered and diagnostic information is translated into appropriate management in real time.

The Coags Uncomplicated App: Fulfilling Educational Gaps Around Diagnosis and Laboratory Testing of Coagulation Disorders.

BackgroundPatients with coagulation disorders may present to a variety of physician specialties; however, accurate and efficient diagnosis can be challenging for physicians not specialized in hematology, due to identified gaps in knowledge around appropriate laboratory assays and interpretation of test results. Coags Uncomplicated was developed to fill this unmet educational need by increasing practical knowledge of coagulation disorders among nonexpert physicians and other health care professionals (HCPs) in a point-of-care (POC) setting.ObjectiveThe aim of this study was to assess patterns of use of the mobile app Coags Uncomplicated, a tool designed to support education regarding accurate and efficient diagnosis of bleeding disorders.MethodsApp metrics were obtained by tracking registered user data. Additionally, a survey was distributed to registered users, to assess circumstances and frequency of use.ResultsThe most common specialties of 7596 registered US users were hematology-oncology (n=1534, 20.19%), hematology (n=1014, 13.35%), and emergency medicine (n=1222, 16.09%); most identified as physicians (n=4082, 53.74%). Specialties accounting for the greatest numbers of screen views were hematology-oncology (99,390 views), hematology (47,808 views), emergency medicine (23,121 views), and internal medicine (22,586 views). The most common diagnostic endpoints reached were disseminated intravascular coagulation (DIC; 2713 times), liver disease effect (2108 times), and vitamin K deficiency (1584 times). Of 3424 users asked to take the survey, 262 responded (7.65%); most were physicians in direct clinical care (71%) and specialized in hematology-oncology (39%) or emergency medicine (21%). Most frequent use was reported by hematologists (69%, ≥6 times) and hematologists-oncologists (38%, ≥6 times). Most physicians (89.2%) reported using the app for patient-case-related education around appropriate use of laboratory tests in diagnostic evaluation. Physicians rated Lab Value Analyzer (mean 4.43) and Lab Test Algorithm (mean 4.46) tools highly on a 5-point “how helpful” scale and were likely to recommend the app to colleagues.ConclusionsApp use among physicians and other HCPs is consistent with value as a POC educational tool, which may facilitate differential diagnoses and appropriate early consultation with hematologists.

Essential and Nonessential Blood Testing in the Clinical Teaching Unit.

The aim of the study was to evaluate the essential and nonessential blood tests ordered on the internal medicine clinical teaching units (CTUs) at Kingston General Hospital. Our aim was to establish a baseline performance measure identifying appropriate use of laboratory tests that could be used to inform improvement over time. For an 8-week period, 14 CTU attending physicians at Kingston General Hospital were surveyed. They were asked for each of their patients, "What blood tests do you consider to be essential for tomorrow morning to maintain appropriate care for this patient?" The following day, blood tests that were ordered were compared with the "essential" list previously given by the attending physicians. Of 291 processed blood tests, 148 (51%) had not been considered essential by attending physicians; of the 203 tests considered essential, 60 (30%) were not ordered. Total agreement between "essential" and processed tests was poor (κ = 0.51; confidence interval, 0.45-0.56). Inadequate use of blood tests for CTU patients is common. Quality improvement initiatives should aim to address the lack of observed consensus between attending physicians' views and the ordered tests and to streamline decision-making and the ordering/communication processes. Clinical standards and guidelines regarding ordering of laboratory tests should be clearly defined.

Impact of Laboratory Test Use Strategies in a Turkish Hospital

ObjectivesEliminating unnecessary laboratory tests is a good way to reduce costs while maintain patient safety. The aim of this study was to define and process strategies to rationalize laboratory use in Ankara Numune Training and Research Hospital (ANH) and calculate potential savings in costs.MethodsA collaborative plan was defined by hospital managers; joint meetings with ANHTA and laboratory professors were set; the joint committee invited relevant staff for input, and a laboratory efficiency committee was created. Literature was reviewed systematically to identify strategies used to improve laboratory efficiency. Strategies that would be applicable in local settings were identified for implementation, processed, and the impact on clinical use and costs assessed for 12 months.ResultsLaboratory use in ANH differed enormously among clinics. Major use was identified in internal medicine. The mean number of tests per patient was 15.8. Unnecessary testing for chloride, folic acid, free prostate specific antigen, hepatitis and HIV testing were observed. Test panel use was pinpointed as the main cause of overuse of the laboratory and the Hospital Information System test ordering page was reorganized. A significant decrease (between 12.6–85.0%) was observed for the tests that were taken to an alternative page on the computer screen. The one year study saving was equivalent to 371,183 US dollars.ConclusionHospital-based committees including laboratory professionals and clinicians can define hospital based problems and led to a standardized approach to test use that can help clinicians reduce laboratory costs through appropriate use of laboratory tests.

Primary Care Use of Laboratory Tests in Spain: Measurement Through Appropriateness Indicators

To compare the inter-practice and inter-regional variability in laboratory test requests by general practitioners in Spain, through the measure of appropriateness indicators. 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. 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). 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.

"Reducing unnecessary testing in a CPOE system through implementation of a targeted CDS intervention".

BackgroundWe describe and evaluate the development and use of a Clinical Decision Support (CDS) intervention; an alert, in response to an identified medical error of overuse of a diagnostic laboratory test in a Computerized Physician Order Entry (CPOE) system. CPOE with embedded CDS has been shown to improve quality of care and reduce medical errors. CPOE can also improve resource utilization through more appropriate use of laboratory tests and diagnostic studies. Observational studies are necessary in order to understand how these technologies can be successfully employed by healthcare providers.MethodsThe error was identified by the Test Utilization Committee (TUC) in September, 2008 when they noticed critical care patients were being tested daily, and sometimes twice daily, for B-Type Natriuretic Peptide (BNP). Repeat and/or serial BNP testing is inappropriate for guiding the management of heart failure and may be clinically misleading. The CDS intervention consists of an expert rule that searches the system for a BNP lab value on the patient. If there is a value and the value is within the current hospital stay, an advisory is displayed to the ordering clinician. In order to isolate the impact of this intervention on unnecessary BNP testing we applied multiple regression analysis to the sample of 41,306 patient admissions with at least one BNP test at LVHN between January, 2008 and September, 2011.ResultsOur regression results suggest the CDS intervention reduced BNP orders by 21% relative to the mean. The financial impact of the rule was also significant. Multiplying by the direct supply cost of $28.04 per test, the intervention saved approximately $92,000 per year.ConclusionsThe use of alerts has great positive potential to improve care, but should be used judiciously and in the appropriate environment. While these savings may not be generalizable to other interventions, the experience at LVHN suggests that appropriately designed and carefully implemented CDS interventions can have a substantial impact on the efficiency of care provision.

Amebic infection in humans

Clinical human infections with the protozoa Entamoeba histolytica is still estimated to occur in 50 million people worldwide, of which approximately 100,000 die annually. Although most clinical symptoms are due to involvement of the large intestine, 1 % present with involvement of the liver in the form of a liver abscess, a potentially fatal condition. Distinguishing an invasive form (E. histolytica) from a morphologically identical non-invasive one (E. dispar) requires molecular or enzymatic characterization. Further, the pattern of infection, interpretation of presence of antibodies in the host, manifestations of disease, approach to investigations and strategies for management remain complex. This article also provides a comprehensive review of the parasite and host factors that govern the complex relationship of the prozoa and humans, and tries to explain why some develop a particular form of the disease in endemic zones. Application of modern imaging and image guided therapy seems to be playing a major role in diagnosis and management of the potentially most serious form of the disease, amebic liver abscess. Despite lack of controlled studies there is a tendency to lower the threshold of their use in clinical practice, and indeed in-hospital mortality rate seems to be falling for amebic liver abscess. In a world getting increasingly swamped by non-infectious metabolic diseases, awareness of amebic infections, its bed-side diagnosis, the use of appropriate laboratory tests, and decision making in management are shrinking. This review tries to update the scientific developments in amebiasis.

The Management of Treatment‐Experienced HIV‐Infected Patients: New Drugs and Drug Combinations

The recent availability of new antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection has increased treatment options and has improved the durability, tolerability, and long-term efficacy of antiretroviral therapy, even among patients with extensive treatment experience and high levels of drug resistance. This expansion of therapeutic options has led to a revision of current treatment guidelines, which now state that the goal of antiretroviral therapy in all patients is suppression of the plasma HIV RNA level to <50 copies/mL. Successful management of infection for treatment-experienced patients with the new agents requires an understanding of their pharmacology and resistance patterns and the appropriate use of laboratory testing to optimize regimen selection. This review discusses the use of recently approved antiretroviral agents in the management of HIV infection in treatment-experienced patients.