The American Society for Microbiology collaboration with the CDC Laboratory Medicine Best Practices initiative for evidence-based laboratory medicine.

SUMMARYClinical medicine has embraced the use of evidence for patient treatment decisions; however, the evaluation strategy for evidence in laboratory medicine practices has lagged. It was not until the end of the 20th century that the Institute of Medicine (IOM), now the National Academy of Medicine, and the Centers for Disease Control and Prevention, Division of Laboratory Systems (CDC DLS), focused on laboratory tests and how testing processes can be designed to benefit patient care. In collaboration with CDC DLS, the American Society for Microbiology (ASM) used an evidence review method developed by the CDC DLS to develop a program for creating laboratory testing guidelines and practices.

Prevalence of ciprofloxacin resistance and associated genetic determinants differed among Campylobacter isolated from human and poultry meat sources in Pennsylvania.

Poultry is the primary source of Campylobacter infections and severe campylobacteriosis cases are treated with macrolides and fluoroquinolones. However, these drugs are less effective against antimicrobial-resistant strains. Here, we investigated the prevalence of phenotypic antimicrobial resistance and associated resistance genetic determinants in Campylobacter isolates collected from human clinical (N = 123) and meat (N = 80) sources in Pennsylvania in 2017 and 2018.

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis.

In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis.

Risk factors for antimicrobial resistance among Staphylococcus isolated from pets living with a patient diagnosed with methicillin-resistant Staphylococcus aureus infection.

It has been suggested that pets play a critical role in the maintenance of methicillin-resistant (MR) and multidrug-resistant (MDR) Staphylococcus spp. in the household. We examined risk factors for carriage of antimicrobial-resistant coagulase-positive staphylococci, with particular attention to Staphylococcus aureus and Staphylococcus pseudintermedius isolated from pets living in households of people diagnosed with methicillin-resistant S.

Phylogenetic Analysis Reveals Source Attribution Patterns for spp. in Tennessee and Pennsylvania.

Campylobacteriosis is the most common bacterial foodborne illness in the United States and is frequently associated with foods of animal origin. The goals of this study were to compare clinical and non-clinical populations from Tennessee (TN) and Pennsylvania (PA), use phylogenetic relatedness to assess source attribution patterns, and identify potential outbreak clusters. isolates studied ( = 3080) included TN clinical isolates collected and sequenced for routine surveillance, PA clinical isolates collected from patients at the University of Pennsylvania Health System facilities, and non-clinical isolates from both states for which sequencing reads were available on NCBI.

Reduction in Sporadic Norovirus Infections Following the Start of the COVID-19 Pandemic, 2019-2020, Philadelphia.

Introduction: Norovirus infections are common in the USA and worldwide. Detection of norovirus in fecal samples is now common in routine tests for enteric pathogens using molecular methods. We observed a change in positivity rates for norovirus after the beginning of the coronavirus disease 2019 (COVID-19) pandemic in our laboratory and performed a more detailed analysis of testing results.

Resistance patterns of refractory infection in a referral center in the Delaware Valley.

Introduction: (HP) resistance is increasing in the US. Guidelines suggest treatment based on local resistance patterns, yet are poorly studied. We describe resistance patterns of the Delaware Valley.

Reducing Blood Culture Contamination Rates: Experiences of Four Hospital Systems.

Introduction: Blood cultures (BCs) frequently become contaminated during the pre-analytic phase of collection leading to downstream ramifications. We present a summary of performance improvement (PI) interventions provided by four hospital systems and common factors that contributed to decreased blood culture contamination (BCC) rates.

Methods: Each hospital independently formed a multidisciplinary team and action plan for implementation of their intervention, focusing on the use of educational and training tools.

Prospective Genotyping to Guide Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Pragmatic Randomized Clinical Trial.

Background: loss-of-function alleles impair clopidogrel effectiveness after percutaneous coronary intervention, but the clinical impact of implementing genotyping in a real-world setting is unknown. The purpose of the study was to determine whether returning genotype results along with genotype-guided pharmacotherapy recommendations using a rapid turnaround test would change antiplatelet prescribing following percutaneous coronary intervention.The primary outcome was the rate of prasugrel or ticagrelor prescribing in each arm.

Whole-Genome Sequencing To Identify Drivers of Carbapenem-Resistant Klebsiella pneumoniae Transmission within and between Regional Long-Term Acute-Care Hospitals.

Carbapenem-resistant (CRKP) is an antibiotic resistance threat of the highest priority. Given the limited treatment options for this multidrug-resistant organism (MDRO), there is an urgent need for targeted strategies to prevent transmission. Here, we applied whole-genome sequencing to a comprehensive collection of clinical isolates to reconstruct regional transmission pathways and analyzed this transmission network in the context of statewide patient transfer data and patient-level clinical data to identify drivers of regional transmission.

A Laboratory Medicine Best Practices Systematic Review and Meta-analysis of Nucleic Acid Amplification Tests (NAATs) and Algorithms Including NAATs for the Diagnosis of () in Adults.

The evidence base for the optimal laboratory diagnosis of () in adults is currently unresolved due to the uncertain performance characteristics and various combinations of tests. This systematic review evaluates the diagnostic accuracy of laboratory testing algorithms that include nucleic acid amplification tests (NAATs) to detect the presence of The systematic review and meta-analysis included eligible studies (those that had PICO [population, intervention, comparison, outcome] elements) that assessed the diagnostic accuracy of NAAT alone or following glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs) or GDH EIAs plus toxin EIAs (toxin). The diagnostic yield of NAAT for repeat testing after an initial negative result was also assessed.

A Clinical Prediction Tool for Extended-Spectrum Cephalosporin Resistance in Community-Onset Enterobacterales Urinary Tract Infection.

Background: Bacterial resistance to first line antibiotics used to treat community-onset urinary tract infections (UTIs) continues to increase. We sought to create a clinical prediction tool for community-onset UTIs due to extended-spectrum cephalosporin-resistant (ESC-R) Enterobacterales (formerly Enterobacteriaceae, EB).

Methods: A case-control study was performed.

The role of extended-spectrum cephalosporin-resistance in recurrent community-onset Enterobacteriaceae urinary tract infections: a retrospective cohort study.

Background: Bacterial resistance to first line antibiotics used to treat community-onset urinary tract infections (UTIs) continues to emerge. We sought to determine the association between extended-spectrum cephalosporin resistance (ESC-R) and recurrence among Enterobacteriaceae (EB) UTIs.

Methods: A retrospective cohort study was performed.

Poor clinical outcomes associated with community-onset urinary tract infections due to extended-spectrum cephalosporin-resistant Enterobacteriaceae.

Objective: Resistance to extended-spectrum cephalosporins (ESC) among Enterobacteriaceae (EB) is increasingly prevalent. We sought to determine the clinical outcomes associated with community-onset ESC-resistant (ESC-R) EB urinary tract infections (UTIs) in a US health system.

Design: Retrospective cohort study.

Blood culture utilization at an academic hospital: Addressing a gap in benchmarking.

Objective: To describe the pattern of blood culture utilization in an academic university hospital setting.

Design: Retrospective cohort study.

Setting: A 789-bed tertiary-care university hospital that processes 40,000+blood cultures annually.

Combined Biomarkers Predict Acute Mortality Among Critically Ill Patients With Suspected Sepsis.

Objectives: Sepsis is associated with high early and total in-hospital mortality. Despite recent revisions in the diagnostic criteria for sepsis that sought to improve predictive validity for mortality, it remains difficult to identify patients at greatest risk of death. We compared the utility of nine biomarkers to predict mortality in subjects with clinically suspected bacterial sepsis.

Isolation of Campylobacter Species from Stool Samples by Use of a Filtration Method: Assessment from a United States-Based Population.

Fecal samples submitted to our clinical microbiology laboratory from patients in the Philadelphia region were prospectively analyzed for species other than and using a filtration method and microaerobic conditions with increased H concentrations. Of 225 samples tested, 13 (5.8%) yielded species, with frequent isolation of The majority of species were not clinically significant.

Effect of a Price Transparency Intervention in the Electronic Health Record on Clinician Ordering of Inpatient Laboratory Tests: The PRICE Randomized Clinical Trial.

Importance: Many health systems are considering increasing price transparency at the time of order entry. However, evidence of its impact on clinician ordering behavior is inconsistent and limited to single-site evaluations of shorter duration.

Objective: To test the effect of displaying Medicare allowable fees for inpatient laboratory tests on clinician ordering behavior over 1 year.

A Novel Needle-Free Blood Draw Device for Sample Collection From Short Peripheral Catheters.

A new US Food and Drug Administration-cleared needleless blood collection device (PIVO; Velano Vascular, San Francisco, CA) for short peripheral catheters was compared with conventional venipuncture for collecting blood samples for routine laboratory analysis from adult healthy volunteers. The PIVO device was comparable with venipuncture in terms of providing high-integrity samples (no hemolysis or clotting), equivalent laboratory values, and better patient experience as assessed by pain scores. Further studies to assess the overall utility of the PIVO device are warranted.

High fluoroquinolone MIC is associated with fluoroquinolone treatment failure in urinary tract infections caused by fluoroquinolone susceptible Escherichia coli.

Background: Suboptimal clinical response to fluoroquinolone (FQ) therapy has been clearly documented in patients with Salmonella typhi infection with reduced FQ susceptibility. However, the clinical impact of reduced FQ susceptibility on other infections including E. coli urinary tract infections (UTIs) has never been evaluated.

Epidemiology and characteristics of Escherichia coli sequence type 131 (ST131) from long-term care facility residents colonized intestinally with fluoroquinolone-resistant Escherichia coli.

The objective of this study was to evaluate molecular and epidemiologic factors associated with Escherichia coli sequence type 131 (ST131) among long-term care facility (LTCF) residents who acquired gastrointestinal tract colonization with fluoroquinolone-resistant E. coli (FQREC). Colonizing isolates from 37 residents who newly developed FQREC colonization at three LTCFs from 2006 to 2008 were evaluated.

Evaluation of a research use only luminex based assay for measurement of procalcitonin in serum samples.

Research use only (RUO) assays do not undergo a validation process similar to test kits used for clinical purposes. Several studies have suggested that RUO assays need to be validated prior to use in any research studies. We evaluated a research use only Luminex platform based assay for measuring serum procalcitonin levels (Bio-Plex Pro Human Acute Phase Multiplex Assay, Bio-Rad Laboratories, Hercules, CA) for comparability with an FDA cleared assay for procalcitonin (VIDAS B.