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The ability to diagnose and screen for infection is an important component of the US COVID-19 response and is facilitated by public health laboratories (PHLs). Anecdotal media reports and limited case studies have described some of the challenges faced by PHLs during the pandemic, particularly initial challenges related to developing and deploying tests to PHLs, but there has not been a systematic evaluation of the experience of PHLs during the pandemic.To document challenges and lessons learned experienced by local and state PHLs during the COVID-19 pandemic to support generation of best practices for current and future similar emergencies.From February to June 2021, researchers conducted 24 interviews with 68 leaders and staff representing 28 local and state PHLs across 27 states. Thematic analysis of interview content documented operational challenges and any identified solutions or preventive measures used or proposed.Analysis identified the following themes regarding challenges faced among PHLs: strategic decision making and determining the mandate of the PHL; political interference by jurisdictional leadership; federal mismanagement of the emergency; regulatory challenges; managing partnerships with other laboratories; acquisition of appropriate supplies; insufficient information systems; acquiring and retaining workforce; and difficulty accessing sufficient funding.Within the identified themes, key informants provided further elaboration regarding how PHLs experienced, evaded, or solved these challenges. In addition, PHLs described how challenges evolved throughout the course of the COVID-19 pandemic and made proposals regarding how challenges could be prevented or further addressed in the future by laboratories or other decision makers and stakeholders.While fellow laboratories and political leadership may gain inspiration from creative solutions employed by PHLs, recognition of long-standing gaps related to funding, laboratory workforce, and consideration of laboratory needs in preparedness policies must be addressed for future large-scale outbreaks.

Increases in mental health conditions have been documented among the general population and health care workers since the start of the COVID-19 pandemic (1-3). Public health workers might be at similar risk for negative mental health consequences because of the prolonged demand for responding to the pandemic and for implementing an unprecedented vaccination campaign. The extent of mental health conditions among public health workers during the COVID-19 pandemic, however, is uncertain. A 2014 survey estimated that there were nearly 250,000 state and local public health workers in the United States (4). To evaluate mental health conditions among these workers, a nonprobability-based online survey was conducted during March 29-April 16, 2021, to assess symptoms of depression, anxiety, post-traumatic stress disorder (PTSD), and suicidal ideation among public health workers in state, tribal, local, and territorial public health departments. Among 26,174 respondents, 53.0% reported symptoms of at least one mental health condition in the preceding 2 weeks, including depression (32.0%), anxiety (30.3%), PTSD (36.8%), or suicidal ideation (8.4%). The highest prevalence of symptoms of a mental health condition was among respondents aged ≤29 years (range = 13.6%-47.4%) and transgender or nonbinary persons (i.e., those who identified as neither male nor female) of all ages (range = 30.4%-65.5%). Public health workers who reported being unable to take time off from work were more likely to report adverse mental health symptoms. Severity of symptoms increased with increasing weekly work hours and percentage of work time dedicated to COVID-19 response activities. Implementing prevention and control practices that eliminate, reduce, and manage factors that cause or contribute to public health workers' poor mental health might improve mental health outcomes during emergencies.

DNA sequencing of complex microbial communities allows for the classification and quantification of thousands of distinct organisms in diverse environmental niches. We present a three domain “Universal Amplicon” (UA) method to simultaneously amplify DNA from the ribosomal small subunit locus from bacteria, archaea, and eukaryotes (and their organelles) using a single pair of amplification primers. We demonstrate the amenability of the UA to multiplexed Illumina library preparation and MiSeq-based sequencing. We validate the UA by sequencing a commercially available microbial community of known quantitative composition and through direct comparison to a shotgun metagenomics dataset. Following validation, we apply the UA to a time-course study of the wetlands of the Northern Imperial Valley in California and show substantial and variable microbial life in the Salton Sea and nearby waters. We demonstrate that the microbial ecology of the Salton Sea varies on at least a monthly basis and is distinct from the surrounding area. Finally, we contribute an open-source Shiny app for real-time analysis of complex metagenomic communities, with application to this study and far beyond.

We built three successive versions of a thermal decomposition cavity ring-down spectrometer and tested their response to explosives. These explosive compound analyzers successfully detected nitroglycerine, 2,4,6-trinitrotoluene (TNT), pentaerythryl tetranitrate, hexahydro-1,3,5-trinitro-s-triazine and triacetone triperoxide (TATP). We determined the pathlength and limits of detection for each, with the best limit of detection being 13 parts per trillion (ppt) of TNT. For most of the explosive tests, the peak height was higher than the expected value, meaning that peroxy radical chain propagation was occurring with each of the explosives and not just the peroxide TATP.

Background context Exercise therapy for low back pain has long been prescribed as one of the initial remedies for back pain. Traditional therapy is completed under a therapist's supervision and consists of lumbar stabilization, aerobic exercise and stretching exercises. Recent studies have explored treating back pain with aerobic exercise such as walking which can be done anywhere and without supervision which is lower cost and easily administered. Purpose To assess a therapeutic dosage of aerobic exercise that is associated with pain reduction in persons experiencing low back pain. Study design Case series. Participant description Sixteen patients entered the study and twelve patients completed the study (mean ± SD: age 51 ± 11 years; weight 89.2 ± 16 kg). Subjects were included if they were ages 18-65, had chronic back pain lasting for more than 3 months and a score of greater than 30% on the Oswestry Low Back Disability Questionnaire. Methods Subjects underwent a six-week exercise program using the elliptical trainer three times each week. Exercise duration was steadily increased each week for the length of the study. The total cumulative amount of work that coincided with significant reductions in chronic low back pain was then identified. Results At 4 weeks, pain scores were significantly reduced from baseline (3.2 vs 4.7, p

Background context: Exercise therapy for low back pain has long been prescribed as one of the initial remedies for back pain. Traditional therapy is completed under a therapist’s supervision and consists of lumbar stabilization, aerobic exercise and stretching exercises. Recent studies have explored treating back pain with aerobic exercise such as walking which can be done anywhere and without supervision which is lower cost and easily administered. Purpose: To assess a therapeutic dosage of aerobic exercise that is associated with pain reduction in persons experiencing low back pain. Study design: Case series. Participant description: Sixteen patients entered the study and twelve patients completed the study (mean ± SD: age 51 ± 11 years; weight 89.2 ± 16 kg). Subjects were included if they were ages 18–65, had chronic back pain lasting for more than 3 months and a score of greater than 30% on the Oswestry Low Back Disability Questionnaire. Methods: Subjects underwent a six-week exercise program using the elliptical trainer three times each week. Exercise duration was steadily increased each week for the length of the study. The total cumulative amount of work that coincided with significant reductions in chronic low back pain was then identified. Results: At 4 weeks, pain scores were significantly reduced from baseline (3.2 vs 4.7, p

Summary Insulin homeostasis in pancreatic β cells is now recognized as a critical element in the progression of obesity and type II diabetes (T2D). Proteins that interact with insulin to direct its sequential synthesis, folding, trafficking, and packaging into reserve granules in order to manage release in response to elevated glucose remain largely unknown. Using a conformation-based approach combined with mass spectrometry, we have generated the insulin biosynthetic interaction network (insulin BIN), a proteomic roadmap in the β cell that describes the sequential interacting partners of insulin along the secretory axis. The insulin BIN revealed an abundant C2 domain-containing transmembrane protein 24 (TMEM24) that manages glucose-stimulated insulin secretion from a reserve pool of granules, a critical event impaired in patients with T2D. The identification of TMEM24 in the context of a comprehensive set of sequential insulin-binding partners provides a molecular description of the insulin secretory pathway in β cells.

Managing ecosystems to maintain biodiversity may be one approach to ensuring their dynamic stability, productivity, and delivery of vital services. The applicability of this approach to industrial ecosystems that harness the metabolic activities of microbes has been proposed but has never been tested at relevant scales. We used a tag-sequencing approach with bacterial small subunit rRNA (16S) genes and eukaryotic internal transcribed spacer 2 (ITS2) to measuring the taxonomic composition and diversity of bacteria and eukaryotes in an open pond managed for bioenergy production by microalgae over a year. Periods of high eukaryotic diversity were associated with high and more-stable biomass productivity. In addition, bacterial diversity and eukaryotic diversity were inversely correlated over time, possibly due to their opposite responses to temperature. The results indicate that maintaining diverse communities may be essential to engineering stable and productive bioenergy ecosystems using microorganisms.

Ambulatory surgery centers remain strong sites for physician services in the outpatient setting. The relationship between endoscopists and surgery centers can be complex from a financial and legal standpoint. The interpretation of Stark and Anti-Kickback laws is a dynamic target, constantly being sifted by legal minds, and is the topic of review in this chapter. Other important issues are reviewed within the context of current interpretation and analysis.

This prospective, multicenter, community-based and academic-based, open-label, investigator-initiated, U.S. study evaluated efficacy and safety of pegylated interferon (PEG-IFN) alfa-2b plus a flat or weight-based dose of ribavirin (RBV) in adults with chronic hepatitis C. Patients (n = 5027) were randomly assigned to receive PEG-IFN alfa-2b 1.5 μg/kg/week plus flat-dose (800 mg/day) or weight-based (800-1400 mg/day) RBV for 48 weeks (patients with genotype 1, 4, 5, or 6) and for 24 or 48 weeks (genotype 2/3 patients). Primary end point was sustained virologic response (undetectable [

Sugarcane is a major crop used for food and bioenergy production. Modern cultivars are hybrids derived from crosses between Saccharum officinarum and Saccharum spontaneum. Hybrid cultivars combine favorable characteristics from ancestral species and contain a genome that is highly polyploid and aneuploid, containing 100-130 chromosomes. These complex genomes represent a huge challenge for molecular studies and for the development of biotechnological tools that can facilitate sugarcane improvement. Here, we describe full-length enriched cDNA libraries for Saccharum officinarum, Saccharum spontaneum, and one hybrid genotype (SP803280) and analyze the set of open reading frames (ORFs) in their genomes (i.e., their ORFeomes). We found 38,195 (19%) sugarcane-specific transcripts that did not match transcripts from other databases. Less than 1.6% of all transcripts were ancestor-specific (i.e., not expressed in SP803280). We also found 78,008 putative new sugarcane transcripts that were absent in the largest sugarcane expressed sequence tag database (SUCEST). Functional annotation showed a high frequency of protein kinases and stress-related proteins. We also detected natural antisense transcript expression, which mapped to 94% of all plant KEGG pathways; however, each genotype showed different pathways enriched in antisense transcripts. Our data appeared to cover 53.2% (17,563 genes) and 46.8% (937 transcription factors) of all sugarcane full-length genes and transcription factors, respectively. This work represents a significant advancement in defining the sugarcane ORFeome and will be useful for protein characterization, single nucleotide polymorphism and splicing variant identification, evolutionary and comparative studies, and sugarcane genome assembly and annotation.

The effects of sediment storage time were determined for three sediment toxicity tests: the amphipod test using Rhepoxynius abronius, the polychaete test using Neanthes sp., and the Microtox{reg_sign} test using Photobacterium phosphoreum. Sediments were collected from a reference area and a contaminated area in Puget Sound to determine the effects of storage time on each type of sediment. Toxicity comparisons were also made between the two kinds of sediment to simulate the manner in which the data might be analyzed in a regulatory or decision-making context. Sediments were stored at 4 C for as long as 16 weeks. Results of all three toxicity tests varied significantly with storage time for each type of sediment. Amphipod survival generally decreased with storage time, whereas luminescence in the Microtox test and polychaete biomass varied unpredictably. The significance of differences between results for the two sediments varied unpredictably with storage time for the amphipod and Microtox tests. By contrast, differences were consistently significant for all storage times for the polychaete test, primarily because of the large differences in the test response between sediments. These results suggest that effects of storage time are greater for results indicative of low to intermediate levels of toxicity thanmore » for results indicative of high levels of toxicity. It is recommended that sediments be tested as soon as possible after field collection to minimize the potential for alterations of toxicity during storage.« less

Hospitals and health systems, whether general acute care hospitals or specialty-driven hospitals, are attempting to prosper in a unique time. This year, hospitals throughout the country will see increased reimbursement for hospital inpatient services, rather than decreased reimbursement. Many hospitals are examining a multitude of options for debt financing and a number of the nation's hospitals are in the process of renovating, expanding, or replacing their current hospitals. Further, more private equity and venture capital funds are pursuing hospital investments than seen in several years. Despite the positive signals stemming from many of the country's hospitals, this remains a time of tremendous uncertainty and risk in the hospital industry. This article discusses five strategic and development issues facing many hospitals and addresses how hospitals can prepare for the future should the current climate, supportive of growth, development, investment, and debt financing, change.

Investment in health care companies can be a good bet over the long term for a number of reasons, particularly in certain sectors within health care. Investment in other health care sectors is much riskier. This article briefly overviews investment considerations for several different sectors within health care.

Laboratory sediment bioassays and alterations of benthic macroinvertebrate assemblages were evaluated at 43 stations in Commencement Bay, Washington, and at 4 stations in Carr Inlet, Washington (a reference embayment). Three bioassays were evaluated: the amphipod mortality test using Rhepoxynius abronius, the oyster larvae abnormality test using Crassostrea gigas and the Microtox® test using Photobacterium phosphoreum. Alterations of benthic assemblages were determined using numerical classification analysis. Bioassay responses and alterations of benthic assemblages were closely related to chemical contamination, suggesting that most biological effects resulted from chemical toxicity. Although all three bioassays were reasonably successful in predicting the presence or absence of moderately to severely altered benthic assemblages, considerable differences were found in the ability of the tests to identify only the altered assemblages. The Microtox bioassay successfully identified the highest percentage of altered benthic assemblages. By contrast, the oyster larvae abnormality bioassay falsely predicted the lowest percentage of altered assemblages. Tiered application of results of both the Microtox and oyster larvae tests improved the accuracy with which altered assemblages were identified.

The use of fairness opinions has become increasingly common with respect to the sale or merger of any company or division in a private equity funded or sponsored deal. The fairness opinion is often used to demonstrate that the value at which the transaction took place was a fair value to the selling company and thus did not improperly or unfairly leave the common holders with little consideration. This article covers rules and guidelines that should be adhered to in the issuance and review of fairness opinions.

Background: Natalizumab, a humanized monoclonal IgG4 antibody to α4 integrin, was investigated as a treatment of active Crohn's disease (CD). The safety of natalizumab given in combination with infliximab has not previously been studied. Methods: Seventy-nine adult patients with active CD (Crohn's Disease Activity Index [CDAI] score ≥ 150) despite ongoing infliximab treatment were randomized 2:1 to receive 3 intravenous infusions of natalizumab (300 mg; n = 52) or placebo (n = 27) every 4 weeks. Patients received infliximab (5 mg/kg) every 8 weeks for at least 10 weeks before randomization and throughout the study. The primary objective was to assess the short-term safety and tolerability of natalizumab in patients concurrently receiving infliximab. Secondary and tertiary objectives included measures of efficacy, health-related quality of life (HRQoL), and effects on inflammatory markers. A subset of patients also participated in a pharmacokinetic/pharmacodynamic (PK/PD) analysis of the effects of concurrent treatment. Results: Incidence of adverse events (AEs) was similar in the treatment groups. AEs frequently reported in both groups were headache, CD exacerbation, nausea, and nasopharyngitis. No patient had a hypersensitivity-like reaction to natalizumab, whereas 4 patients (5%) experienced reactions to infliximab. Two patients (4%) developed anti-natalizumab antibodies; 10 patients (14%) developed anti-infliximab antibodies. The mean CDAI score decreased with natalizumab plus infliximab but was unchanged with infliximab alone (−37.7 versus +3.5; P = 0.084). Patients in both groups showed small increases in HRQoL (P = 0.811). No drug–drug interactions were noted. Conclusions: The combination of natalizumab plus infliximab was well tolerated. Several positive trends suggested that treating patients not in remission with infliximab plus natalizumab had greater efficacy than treatment with infliximab alone. (Inflamm Bowel Dis 2007;13:2–11)

This article provides an overview of several issues facing the orthopedic-driven ambulatory surgery center and specialty hospital development industry. The article specifically then reviews certain key business drivers to industry growth, examines key risks related to ASC and specialty hospital projects, and provides a brief review of certain legal issues related to the same.

This article has addressed certain of the key federal regulatory schemes governing ASCs with which owners and operators of ASCs should be familiar. In addition to the regulatory schemes addressed herein, we encourage owners and operators of ASCs to familiarize themselves with other critical requirements such as those relating to antitrust issues, taxation issues and state requirements regarding licensure, certification, ownership arrangements, and reimbursement.

The growth in the number of ambulatory surgery centers, coupled with the unique guidance provided by the OIG in this area, provide a fascinating legal and regulatory environment for ambulatory surgery centers.