Pandemic Demand for SARS-CoV-2 Testing Led to Critical Supply and Workforce Shortages in U.S. Clinical and Public Health Laboratories.

COVID-19 has brought unprecedented challenges to clinical and public health laboratories. While U.S. laboratories have continued striving to provide quality test results during the pandemic, the uncertainty and lack of supplies became a significant hurdle, hindering day-to-day laboratory operations and the ability to increase testing capacity for both SARS-CoV-2 and non-COVID-19 testing. In addition, long-standing laboratory workforce shortages became apparent, hindering the ability of clinical and public health laboratories to rapidly increase testing. The American Society for Microbiology, the College of American Pathologists, the National Coalition of STD Directors, and the Emerging Infections Network independently conducted surveys in 2020 and early 2021 to assess the capacity of the nation's clinical laboratories to respond to the increase in demand for testing during the COVID-19 pandemic. The results of these surveys highlighted the shortages of crucial supplies for SARS-CoV-2 testing and supplies for other routine laboratory diagnostics, as well as a shortage of trained personnel to perform testing. The conclusions are based on communications, observations, and the survey results of the clinical laboratory, public health, and professional organizations represented here. While the results of each survey considered separately may not be representative of the entire community, when considered together they provide remarkably similar results, further validating the findings and highlighting the importance of laboratory supply chains and the personnel capable of performing these tests for any response to a large-scale public health emergency.

Assessing the social cost and benefits of a national requirement establishing antibiotic stewardship programs to prevent Clostridioides difficile infection in US hospitals.

Backgound: Economic evaluations of interventions to prevent healthcare-associated infections in the United States rarely take the societal perspective and thus ignore the potential benefits of morbidity and mortality risk reductions. Using new Department of Health and Human Services guidelines for regulatory impact analysis, we developed a cost-benefit analyses of a national multifaceted, in-hospital Clostridioides difficile infection prevention program (including staffing an antibiotic stewardship program) that incorporated value of statistical life estimates to obtain economic values associated with morbidity and mortality risk reductions. Methods: We used a net present value model to assess costs and benefits associated with antibiotic stewardship programs. Model inputs included treatment costs, intervention costs, healthcare-associated Clostridioides difficile infection cases, attributable deaths, and the value of statistical life which was used to estimate the economic value of morbidity and mortality risk reductions. Results: From 2015 to 2020, total net benefits of the intervention to the healthcare system range from $300 million to $7.6 billion when values for morbidity and mortality risk reductions are ignored. Including these values, the net social benefits of the intervention range from $21 billion to $624 billion with the annualized net benefit of $25.5 billion under our most likely outcome scenario. Conclusions: Incorporating the economic value of morbidity and mortality risk reductions in economic evaluations of healthcare-associated infections will significantly increase the benefits resulting from prevention.

Assessment of the Overall and Multidrug-Resistant Organism Bioburden on Environmental Surfaces in Healthcare Facilities.

OBJECTIVE To determine the typical microbial bioburden (overall bacterial and multidrug-resistant organisms [MDROs]) on high-touch healthcare environmental surfaces after routine or terminal cleaning. DESIGN Prospective 2.5-year microbiological survey of large surface areas (>1,000 cm2). SETTING MDRO contact-precaution rooms from 9 acute-care hospitals and 2 long-term care facilities in 4 states. PARTICIPANTS Samples from 166 rooms (113 routine cleaned and 53 terminal cleaned rooms). METHODS Using a standard sponge-wipe sampling protocol, 2 composite samples were collected from each room; a third sample was collected from each Clostridium difficile room. Composite 1 included the TV remote, telephone, call button, and bed rails. Composite 2 included the room door handle, IV pole, and overbed table. Composite 3 included toileting surfaces. Total bacteria and MDROs (ie, methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci [VRE], Acinetobacter baumannii, Klebsiella pneumoniae, and C. difficile) were quantified, confirmed, and tested for drug resistance. RESULTS The mean microbial bioburden and range from routine cleaned room composites were higher (2,700 colony-forming units [CFU]/100 cm2; ≤1-130,000 CFU/100 cm2) than from terminal cleaned room composites (353 CFU/100 cm2; ≤1-4,300 CFU/100 cm2). MDROs were recovered from 34% of routine cleaned room composites (range ≤1-13,000 CFU/100 cm2) and 17% of terminal cleaned room composites (≤1-524 CFU/100 cm2). MDROs were recovered from 40% of rooms; VRE was the most common (19%). CONCLUSIONS This multicenter bioburden summary provides a first step to determining microbial bioburden on healthcare surfaces, which may help provide a basis for developing standards to evaluate cleaning and disinfection as well as a framework for studies using an evidentiary hierarchy for environmental infection control. Infect Control Hosp Epidemiol 2016;1426-1432.

Predicting the risk for hospital-onset Clostridium difficile infection (HO-CDI) at the time of inpatient admission: HO-CDI risk score.

OBJECTIVE: To predict the likelihood of hospital-onset Clostridium difficile infection (HO-CDI) based on patient clinical presentations at admission DESIGN: Retrospective data analysis SETTING: Six US acute care hospitals PATIENTS: Adult inpatients METHODS: We used clinical data collected at the time of admission in electronic health record (EHR) systems to develop and validate a HO-CDI predictive model. The outcome measure was HO-CDI cases identified by a nonduplicate positive C. difficile toxin assay result with stool specimens collected >48 hours after inpatient admission. We fit a logistic regression model to predict the risk of HO-CDI. We validated the model using 1,000 bootstrap simulations. RESULTS: Among 78,080 adult admissions, 323 HO-CDI cases were identified (ie, a rate of 4.1 per 1,000 admissions). The logistic regression model yielded 14 independent predictors, including hospital community onset CDI pressure, patient age ≥65, previous healthcare exposures, CDI in previous admission, admission to the intensive care unit, albumin ≤3 g/dL, creatinine >2.0 mg/dL, bands >32%, platelets ≤150 or >420 109/L, and white blood cell count >11,000 mm3. The model had a c-statistic of 0.78 (95% confidence interval [CI], 0.76-0.81) with good calibration. Among 79% of patients with risk scores of 0-7, 19 HO-CDIs occurred per 10,000 admissions; for patients with risk scores >20, 623 HO-CDIs occurred per 10,000 admissions (P<.0001). CONCLUSION: Using clinical parameters available at the time of admission, this HO-CDI model demonstrated good predictive ability, and it may have utility as an early risk identification tool for HO-CDI preventive interventions and outcome comparisons.

The cost-benefit of federal investment in preventing Clostridium difficile infections through the use of a multifaceted infection control and antimicrobial stewardship program.

OBJECTIVE: To determine the potential epidemiologic and economic value of the implementation of a multifaceted Clostridium difficile infection (CDI) control program at US acute care hospitals DESIGN: Markov model with a 5-year time horizon PARTICIPANTS: Patients whose data were used in our simulations were limited to hospitalized Medicare beneficiaries ≥65 years old. BACKGROUND: CDI is an important public health problem with substantial associated morbidity, mortality, and cost. Multifaceted national prevention efforts in the United Kingdom, including antimicrobial stewardship, patient isolation, hand hygiene, environmental cleaning and disinfection, and audit, resulted in a 59% reduction in CDI cases reported from 2008 to 2012. METHODS: Our analysis was conducted from the federal perspective. The intervention we modeled included the following components: antimicrobial stewardship utilizing the Antimicrobial Use and Resistance module of the National Healthcare Safety Network (NHSN), use of contact precautions, and enhanced environmental cleaning. We parameterized our model using data from CDC surveillance systems, the AHRQ Healthcare Cost and Utilization Project, and literature reviews. To address uncertainty in our parameter estimates, we conducted sensitivity analyses for intervention effectiveness and cost, expenditures by other federal partners, and discount rate. Each simulation represented a cohort of 1,000 hospitalized patients over 1,000 trials. RESULTS In our base case scenario with 50% intervention effectiveness, we estimated that 509,000 CDI cases and 82,000 CDI-attributable deaths would be prevented over a 5-year time horizon. Nationally, the cost savings across all hospitalizations would be $2.5 billion (95% credible interval: $1.2 billion to $4.0 billion). CONCLUSIONS: The potential benefits of a multifaceted national CDI prevention program are sizeable from the federal perspective.

CDC central-line bloodstream infection prevention efforts produced net benefits of at least $640 Million during 1990-2008.

The prevention of central line-associated bloodstream infections in patients in hospital critical care units has been a target of efforts by the Centers for Disease Control and Prevention (CDC) since the 1960s. We developed a historical economic model to measure the net economic benefits of preventing these infections in Medicare and Medicaid patients in critical care units for the period 1990-2008-a time when reductions attributable to federal investment resulted primarily from CDC efforts-using the cost perspective of the federal government as a third-party payer. The estimated net economic benefits ranged from $640 million to $1.8 billion, with the corresponding net benefits per case averted ranging from $15,780 to $24,391. The per dollar rate of return on the CDC's investments ranged from $3.88 to $23.85. These findings suggest that investments in CDC programs targeting other health care-associated infections also have the potential to produce savings by lowering Medicare and Medicaid reimbursements.

Assessment of public health perspectives on responding to an emerging pathogen: carbapenem-resistant Enterobacteriaceae.

CONTEXT: Public health has an important and critical role in responding to emerging multidrug-resistant organisms, such as carbapenem-resistant Enterobacteriaceae. The Centers for Disease Control and Prevention developed a survey as a tool for state health departments to determine carbapenem-resistant Enterobacteriaceae prevalence within their region. OBJECTIVE: This report summarizes an assessment of the health department experience with the survey, their perceived roles and responsibilities in responding to an emerging health care-associated pathogen, and potential barriers to public health engagement of acute care facilities in response activities. DESIGN: Key informant interviews consisting of open-ended and 5-point Likert scale questions were conducted. PARTICIPANTS: Interviewees represented state health departments that administered the survey and select states that did not. RESULTS: Of 11 states interviewed, 7 (64%) had administered the survey to acute care facilities. Despite similar competing priorities and concerns about administering the survey, different perspectives emerged among the 11 states; those that administered the survey regarded it as a learning opportunity, whereas other states emphasized concerns about survey logistics and other public health demands. All 11 states perceived the prevention of an emerging pathogen to be a public health priority, but the degree of their action depended on availability of resources and existing relationships with infection preventionists. Health departments had less interaction with other hospital personnel (eg, facility leadership) and limited knowledge of the roles and associated responsibilities of other health care partners (eg, Quality Improvement Organizations). CONCLUSIONS: Although considered a public health priority, response efforts to emerging pathogens were reported to vary among state health departments. A better understanding is needed of the factors that motivate and facilitate state health departments to engage in a public health activity despite the challenges of competing priorities and limited resources. Efforts should also focus on improving the relationship between health departments and hospital leadership and other health care partners.

Assessment of Clostridium difficile-associated disease surveillance definitions, North Carolina, 2005.

OBJECTIVE: To determine the timing of community-onset Clostridium difficile-associated disease (CDAD) relative to the patient's last healthcare facility discharge, the association of postdischarge cases with healthcare facility-onset cases, and the influence of postdischarge cases on overall rates and interhospital comparison of rates of CDAD. DESIGN: Retrospective cohort study for the period January 1, 2005, through December 31, 2005. SETTING: Catchment areas of 6 acute care hospitals in North Carolina. METHODS: We reviewed medical and laboratory records to determine the date of symptom onset, the dates of hospitalization, and stool C. difficile toxin assay results for patients with CDAD who had diarrhea and positive toxin-assay results. Cases were classified as healthcare facility-onset if they were diagnosed more than 48 hours after admission. Cases were defined as community-onset if they were diagnosed in the community or within 48 hours after admission, and were also classified on the basis of the time since the last discharge: if within 4 weeks, community-onset, healthcare facility-associated (CO-HCFA); if 4-12 weeks, indeterminate exposure; and if more than 12 weeks, community-associated. Pearson's correlation coefficient was used to assess the association between monthly rates of healthcare facility-onset, healthcare facility-associated (HO-HCFA) cases and CO-HCFA cases. We performed interhospital rate comparisons using HO-HCFA cases only and using both HO-HCFA and CO-HCFA cases. RESULTS: Of 1046 CDAD cases, 442 (42%) were HO-HCFA cases and 604 (58%) were community-onset cases. Of the 604 community-onset cases, 94 (15%) were CO-HCFA, 40 (7%) were of indeterminate exposure, and 208 (34%) community-associated. A modest correlation was found between monthly rates of HO-HCFA cases and CO-HCFA cases across the 6 hospitals (r = 0.63, P < .001). Interhospital rankings changed for 6 of 11 months if CO-HCFA cases were included. CONCLUSIONS: A substantial proportion of community-onset cases of CDAD occur less than 4 weeks after discharge from a healthcare facility, and inclusion of CO-HCFA cases influences interhospital comparisons. Our findings support the use of a proposed definition of healthcare facility-associated CDAD that includes cases that occur within 4 weeks after discharge.

Short- and long-term attributable costs of Clostridium difficile-associated disease in nonsurgical inpatients.

BACKGROUND: The incidence of Clostridium difficile-associated disease (CDAD) is increasing. There are few data on the short-term and long-term attributable costs of CDAD. The objective of this study was to determine the acute and 180-day attributable inpatient costs of CDAD. METHODS: We performed a retrospective cohort study of all patients without operating room costs who were admitted for > or =48 h to Barnes-Jewish Hospital, a tertiary care hospital in St. Louis, Missouri, 1 January 2003-31 December 2003 (n = 24,691). Attributable costs of CDAD were determined by multivariable linear regression and propensity-score matched-pairs analyses (n = 684) for the hospitalization in which CDAD occurred and per patient over a 180-day period, including the initial hospitalization. RESULTS: CDAD was associated with $2454 (95% confidence interval, $2380-$2950; increase in cost, 41%) attributable costs per CDAD episode by linear regression and with $3240 attributable costs (P < .001; increase in cost, 33%) by propensity-score matched-pairs analysis. CDAD was associated with $5042 (95% confidence interval, $3797-$6481; increase in cost, 53%) attributable inpatient costs over 180 days by linear regression and with $7179 attributable costs for inpatient care (P < .001; 48% increase in costs) by propensity-score matched-pairs analysis. CONCLUSIONS: CDAD was associated with a significant increase in costs for inpatient care and increased costs at 180 days after the initial hospitalization when the CDAD episode occurred.

Improving antimicrobial use in the hospital setting by providing usage feedback to prescribing physicians.

OBJECTIVE: To determine whether feedback on antimicrobial use improves physician compliance with local hospital guidelines on antimicrobial prescribing. DESIGN: In this time series analysis, in which a historical control period was compared with an intervention period, all orders for antimicrobials (except those for surgical prophylaxis) placed from November 1, 2002, through April 30, 2004, were prospectively evaluated by an antimicrobial management team (AMT) for compliance with local hospital guidelines. During the control period, orders were evaluated to determine compliance with hospital guidelines before and after recommendations by the AMT were provided to physicians. Feedback was given for the second 9-month period in the form of a weekly report to prescribing physicians, a monthly hospital newsletter, and a quarterly report to various hospital committees. During the intervention period, orders were evaluated to determine compliance with hospital guidelines before and after recommendations by the AMT were provided to physicians. SETTING: The Veterans Affairs Medical Center, a 110-bed facility, in Louisville, Kentucky. PARTICIPANTS: Internal medicine physicians and general surgeons. RESULTS: A total of 2,807 antimicrobial courses were evaluated. Compliance with hospital guidelines before AMT recommendations was 70% during the control period and 74% during the intervention period (P=.02). Compliance after AMT recommendations was 90% during the control period and 93% during the intervention period (P< or =.01). CONCLUSION: The use of feedback had a significantly favorable impact on physician compliance with the hospital's guidelines on antimicrobial prescribing. Use of feedback should be added to the list of interventions that promote appropriate antimicrobial use in the hospital setting.

Vancomycin-resistant staphylococci and enterococci: epidemiology and control.

PURPOSE OF REVIEW: This review updates information on the development and spread of vancomycin resistance in staphylococci and enterococci. RECENT FINDINGS: New information on the genetic characterization of vancomycin-resistant Staphylococcus aureus isolates from the US indicates that each of the four was the result of an independent genetic event. New data suggest that vancomycin-intermediate S. aureus isolates, particularly those showing heteroresistance, are clinically significant. Finally, vancomycin-resistant enterococci continue to be reported from around the world. Novel infection control measures, however, may aid in reducing the spread of these organisms in healthcare settings. SUMMARY: The exchange of genetic information, particularly the vanA gene, between and among staphylococci and enterococci will continue to challenge physicians, microbiologists, and infection control practitioners in efforts to identify, treat, and prevent infections with these pathogens.

Improving antimicrobial use: longitudinal assessment of an antimicrobial team including a clinical pharmacist.

BACKGROUND: Inappropriate antimicrobial utilization in hospitalized patients has been associated with adverse effects, emergence of resistant bacteria, and increased health care cost. Participation of clinical pharmacists, working as an integral part of a hospital antimicrobial management team (AMT), has been shown to improve antimicrobial use; however, the long-term impact of such a team on antimicrobial use is unclear. OBJECTIVE: Our primary objective was to evaluate whether the number of recommendations to improve antimicrobial use made by a hospital AMT decreased over time. Our secondary objective was to identify and evaluate the acceptance of AMT recommendations with respect to the clinical service, site of infection, and category of suboptimal use. METHODS: We retrospectively reviewed antimicrobial utilization data collected by the team for the 3-year period from July 1996 to June 1999 at the Veterans Affairs Medical Center in Louisville, Kentucky. The total number of antimicrobial treatment episodes and the number of recommendations were grouped into periods of 6 months each during the 3 years. The type of recommendation, type of infection, and clinical service (medicine versus surgery) were reviewed for the entire 3-year period. RESULTS: The number of antimicrobial treatment episodes for each of the 6-month consecutive periods was 404, 526, 406, 549, 507, and 612. The proportion of episodes requiring team recommendations was constant over the 5 consecutive periods: 39%, 37%, 36%, 36%, 35%, and 37%. (P = 0.8). Acceptance rates of AMT recommendations by the internal medicine and general surgery services remained stable over the length of the study, 84% and 69%, respectively. The distribution of patients treated by the site of infection also remained stable over the study period. CONCLUSION: Our results demonstrate that despite the long-term presence of an AMT, the proportion of antimicrobial episodes requiring intervention and the percentage of accepted recommendations remained constant over a 3-year period. Having new resident physicians in teaching hospitals or staff turnover in managed care organizations may necessitate the continued presence of an active AMT.