HCV screening, linkage to care, and treatment patterns at different sites across one academic medical center.

BACKGROUND: It is unclear whether sites that screen large numbers of patients for Hepatitis C Virus but achieve limited follow-up are more or less effective at having patients succeed through linkage and treatment than lower volume sites that have higher linkage percentages. The objective was to compare the rates of HCV identification, linkage to care, and treatment success between different study sites including the Emergency Department, 3 outpatient clinics with unique patients, and the inpatient setting at one medical center. METHODS: This is a descriptive analysis of 2 years of data from a protocol that integrated HCV screening and treatment into clinical services throughout multiple departments in one medical center. The program used a best practice advisory to prompt testing at all sites, with different triggers for it to fire at each site, and one central navigation program that attempted to link all patients diagnosed with hepatitis C virus to outpatient care. Outcomes included volume of tests performed in each site, Antibody and RNA rates at each site, demographic data, navigation and linkage outcomes, and post-linkage treatment completion. RESULTS: 28,435 patients were screened across 5 clinical locations. RNA+ rates and absolute numbers linked to MD (linkage rates among all RNA+) were: ED 7.2% RNA+, 224 (22.6%) linked; Inpatient 14.8% RNA+, 27 (17.6%) linked, General Internal Medicine 3.9% RNA+, 269 (65.8%) linked, Infectious Diseases 4.0% RNA+, 34(70.8%) linked, Family Medicine 2.0% RNA+, 28 (75.7%) linked. Demographics, linkage barriers, and treatment initiation rates were different at all sites. CONCLUSION: Among sites there were differences in the sociodemographic characteristics of patients diagnosed with HCV, as well as differences in the success linking patients to outpatient care. At this medical center, the ED screened the most patients, the inpatient area had the highest RNA positivity rate, the FM clinic had the highest linkage rate, GIM linked the most patients by absolute number, and GIM also had the highest number of patients start treatment.

Implementation and Preliminary Results of an Emergency Department Nontargeted, Opt-out Hepatitis C Virus Screening Program.

BACKGROUND: Emergency department (ED) visits provide an opportunity for hepatitis C virus (HCV) screening for patients who otherwise might not be tested. We report on a novel nontargeted, opt-out HCV screening and linkage-to-care (LTC) program implemented in an urban ED. METHODS: This is a descriptive analysis from 3 months (November 2016-January 2017) of a nontargeted, opt-out ED HCV screening and LTC program among patients at least 13 years old undergoing phlebotomy for clinical purposes. A multipurpose best practice advisory (BPA) alerted providers to the program and generated order labels. For patients who authorized testing, specimens were drawn in the ED for HCV antibody (Ab) and reflex confirmatory RNA tests. Public health navigators attempted to contact RNA-positive patients and arrange outpatient visits. RESULTS: HCV Ab tests were performed on 3,808 patients, a 6,950% increase from preprogram. The proportion of HCV Ab test positivity was 13.2% (504/3,808, 95% confidence interval [CI] = 12.2%-14.3%) and of those 97.8% (493/504) had a follow-up RNA test performed. A total of 292 were confirmed positive for active infection, for an overall RNA positivity rate of 7.7% (95% CI = 6.8%-8.5%). Of those with active infection, 155 (53%) were outside the Centers for Disease Control and Prevention birth cohort for increased risk for HCV including 46 (15.8%, 95% CI = 11.8%-20.4%) who also did not report injection drug use. Linkage attempts were documented on 223 (76.4%) patients and appointments were scheduled for 102 (38% of attempted). Sixty-six patients attended their LTC visit (22.5% of all RNA-positive patients, 30% of linkage-eligible patients). CONCLUSIONS: Nontargeted opt-out HCV testing can be successfully implemented in an ED setting. A number of patients diagnosed were outside traditional risk groups. Once diagnosed, an ED population may be difficult to engage in care, but a structured interdisciplinary program can successfully link patients to HCV care.

A Next-Generation Sequencing Primer-How Does It Work and What Can It Do?

Next-generation sequencing refers to a high-throughput technology that determines the nucleic acid sequences and identifies variants in a sample. The technology has been introduced into clinical laboratory testing and produces test results for precision medicine. Since next-generation sequencing is relatively new, graduate students, medical students, pathology residents, and other physicians may benefit from a primer to provide a foundation about basic next-generation sequencing methods and applications, as well as specific examples where it has had diagnostic and prognostic utility. Next-generation sequencing technology grew out of advances in multiple fields to produce a sophisticated laboratory test with tremendous potential. Next-generation sequencing may be used in the clinical setting to look for specific genetic alterations in patients with cancer, diagnose inherited conditions such as cystic fibrosis, and detect and profile microbial organisms. This primer will review DNA sequencing technology, the commercialization of next-generation sequencing, and clinical uses of next-generation sequencing. Specific applications where next-generation sequencing has demonstrated utility in oncology are provided.

Laboratory Testing of Donors and Stool Samples for Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection.

Fecal microbiota transplantation is an efficacious and inexpensive therapy for recurrent Clostridium difficile infection, yet its safety is thought to depend on appropriate fecal donor screening. FDA guidance for regulation of this procedure is in flux, but screening and manufacture of fecal material from asymptomatic donors present many challenges to clinical laboratories. This minireview summarizes FDA regulatory changes, principles of donor selection, and recommended laboratory screening practices for fecal microbiota transplantation.