Joseph F. Perz

Viral Hepatitis Transmission in Ambulatory Health Care Settings

In the United States, transmission of viral hepatitis from health care-related exposures is uncommon and primarily recognized in the context of outbreaks. Transmission is typically associated with unsafe injection practices, as exemplified by several recent outbreaks that occurred in ambulatory health care settings. To prevent transmission of bloodborne pathogens, health care workers must adhere to standard precautions and follow fundamental infection-control principles, including safe injection practices and appropriate aseptic techniques. These principles and practices need to be made explicit in institutional policies and reinforced through in-service education for all personnel involved in direct patient care, including those in ambulatory care settings. The effectiveness of these measures should be monitored as part of the oversight process. In addition, prompt reporting of suspected health care-related cases coupled with appropriate investigation and improved monitoring of surveillance data are needed to accurately characterize and prevent health care-related transmission of viral hepatitis.

An Outbreak of Hepatitis C Virus Infections among Outpatients at a Hematology/Oncology Clinic

Context Hepatitis C virus (HCV) may be transmitted through health careassociated exposure involving poor aseptic technique. Contribution In an outpatient hematology/oncology clinic, 99 patients who did not have previously known HCV infection acquired the virus, apparently because a health care worker reused contaminated syringes and saline bags. Cautions Researchers may have missed some cases because the investigation occurred more than a year after the outbreak. Implications We need active, effective infection-control programs for outpatient care settings. The Editors Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease in the United States (1). It is transmitted primarily through percutaneous exposure to contaminated blood (2). Health careassociated HCV transmission has been attributed to breaches in aseptic technique (3-5). In September 2002, a gastroenterologist notified the Office of Epidemiology at the Nebraska Health and Human Services System in Lincoln, Nebraska, of a cluster of 4 HCV genotype 3a infections in patients who received care at a single outpatient clinic in eastern Nebraska. Because these patients reported no typical risk factors for HCV infection and genotype 3a accounts for less than 8% of HCV infections in the United States, we suspected health careassociated transmission (1). The implicated facility was an independently owned and operated hematology/oncology clinic located inside a hospital complex. The clinic opened in January 1998, and approximately 500 patient visits occurred per month. The staff comprised an oncologist, a registered nurse, a certified nurse assistant, and a secretary. In October 2002, 1 month after the gastroenterologists report, the clinic voluntarily closed. We compared clinic patient lists with Nebraskas HCV, HIV, and hepatitis B virus (HBV) registries and identified a patient with preexisting chronic HCV genotype 3a infection who enrolled at the clinic in March 2000. We found no evidence of HIV or HBV transmission. Preliminary interviews with clinic staff revealed that the nurse who had worked at the clinic since its opening was dismissed in July 2001 because of breaches in infection- control practices. We initiated an investigation to confirm the hypothesis of health careassociated transmission and to determine the extent of the outbreak and its mechanism of transmission. Methods Case Finding and Laboratory Testing Using clinic records, we identified all patients who visited the clinic from March 2000 through December 2001. We contacted all living patients and offered them free HCV testing. Structured in-person interviews were conducted in a private setting with participating patients to assess their medical history, including previous hepatitis diagnosis and risk factors for HCV infection. All specimens were tested for HCV antibodies by using enzyme immunoassay (EIA) (Abbott HCV EIA 2.0, Abbott Laboratories, Abbott Park, Illinois). Positive results on EIA were confirmed by using recombinant immunoblot assay (RIBA) (Chiron RIBA HCV 3.0 SIA, Chiron Corp., Emeryville, California) or HCV qualitative polymerase chain reaction (PCR) (Cobas Amplicor HCV Test v2.0, Roche Molecular Diagnostic Systems, Branchburg, New Jersey) (6). Because of concerns that immunosuppressed patients could have impaired antibody response, we also tested specimens from patients seen before July 2001 by using a transcription-mediated amplification (TMA) assay (Gen-Probe Inc., San Diego, California). A positive HCV test result was defined as a positive finding on TMA or a confirmed positive finding on EIA. Samples that were positive on PCR or TMA were genotyped by using gene sequencing of the 5 untranslated region (PE Applied Biosystems, Foster City, California). Epidemiologic Investigation We reviewed and abstracted the medical records and medication sheets of the tested patients using structured forms to identify clinic-associated risk factors for HCV transmission, such as number of clinic visits, presence of a central venous catheter, and percutaneous exposures. A case was defined as a positive HCV test result in a clinic patient treated from March 2000 through December 2001 who did not have evidence of preexisting HCV infection (that is, abnormal alanine aminotransferase [ALT] levels or positive HCV test results) before enrollment at the clinic. We considered the date of HCV infection onset to be the date when an ALT level greater than 3 times the upper limit of normal was first recorded (7). We conducted a cohort analysis to evaluate the association between exposures at the clinic and HCV infection. To further evaluate the variables associated with HCV infection in the cohort analysis and to investigate potential confounding among these variables, we performed an analysis that focused on risk factor exposure during the period of probable transmission (Appendix). Review of Infection-Control Practices The physician and nurse who worked at the clinic during the outbreak period were unavailable or unwilling to submit to interviews and HCV testing. We interviewed other health care workers and patients to corroborate staff adherence to infection-control standards. Statistical Analysis We made comparisons by using the t-test, the Fisher exact test, or the chi-square test, as appropriate (Epi Info, version 3.01, 2003, Centers for Disease Control and Prevention, Atlanta, Georgia). P values less than 0.05 were considered statistically significant. Results Case Finding and Laboratory Testing A total of 842 patients attended the clinic from March 2000 through December 2001. We contacted the 613 (73%) living patients; 494 of these (81%) agreed to testing. Twenty-one tested patients whose medical charts could not be located were excluded from analysis. No cases were seen among the 103 tested patients who began treatment after the nurses dismissal in July 2001. Therefore, we defined our study period as March 2000 to July 2001 and considered only exposures that occurred during this period. Among the 370 eligible patients, 101 tested positive for HCV: 80 were EIA positive and PCR positive; 18 were EIA negative but TMA positive; and 3 were EIA positive, PCR negative, and RIBA positive. One patient with inconclusive HCV test results (positive EIA, negative PCR and TMA, and indeterminate RIBA results) was excluded from analysis. We also excluded 2 persons with evidence of preexisting HCV infection. One visited the clinic only once, in March 2001, and had elevated ALT levels before that visit. The other person was the presumed outbreak source-patient identified during our preliminary investigation. This patient enrolled at the clinic in March 2000 with preexisting chronic HCV genotype 3a infection (viral load > 200000 copies/mL); a central venous catheter was implanted at that time. The resulting cohort of 367 patients seen at the clinic from March 2000 to July 2001 consisted of 99 HCV-positive patients who lacked evidence of preexisting HCV infection and met the case definition and 268 HCV-negative patients. The overall attack rate was 27% (99 of 367 patients). Genotype 3a was identified in 95 (96%) cases; in 4 cases, low levels or absence of HCV RNA precluded genotype determination. Epidemiologic Investigation Descriptive Epidemiology Most infected patients were female (60%), and the median age was 66 years (range, 21 to 95 years). Ninety-five of the 99 patients (96%) had cancer as an underlying disease, and the median number of clinic visits was 21 (range, 3 to 78 visits). Signs and symptoms of acute HCV infection were uncommon: Four (4%) patients had clinical jaundice, and 16 (16%) reported nausea. We estimated an onset date of infection for 56 (57%) case-patients (Figure). Only 2 (2%) case-patients exhibited spontaneous viral clearance (that is, undetectable HCV RNA) at the time of the investigation. Figure. Number of cases of hepatitis C virus infection, by estimated onset date ( n = 56) (Nebraska, March 2000July 2001). Eighty-three (84%) infected patients had a central venous catheter in place while receiving care at the clinic. Twenty-six (26%) infected patients did not receive any intravenous drug at the clinic during the outbreak period, but did have catheters flushed with saline solution. All 99 patients who developed HCV infection visited the clinic the same day as a previously HCV-infected patient and had saline flushes on those days. Analytic Epidemiology Among the 367 patients in the cohort analysis, 140 (38%) received 1 or more saline flushes during the study period (Table 1). Of those, 99 (71%) became infected, compared with no infection among the 227 patients who did not receive a saline flush during that time (relative risk, undefined; P< 0.001). Bivariate analysis also indicated an association between HCV infection and 5 other variables: sex, underlying diagnosis, presence of central venous catheter, exposure to subcutaneous injections, and number of clinic visits. Table 1. Attack Rates of Hepatitis C Virus Infection, by Demographic and Selected Clinical Characteristics, among 367 Tested Patients at the Hematology/Oncology Clinic, March 2000July 2001 In the multivariable analysis using the case-patients with estimated date of onset, only the number of saline flushes remained significantly associated with HCV infection in our model (adjusted odds ratio, 2.1 [95% CI, 1.3 to 3.2]) (Table 2; methods described in Appendix). Of note, the 10 case-patients with the earliest onset dates all received a saline flush on a day when the source-patient visited the clinic (Appendix Figure). Appendix Figure. Timeline of clinic visits for the 10 case-patients with the earliest dates of onset and for the source-patient (Nebraska, March 2000July 2001). Table 2. Unconditional Multivariable Analysis of Risk Factors for Hepatitis C Virus Infection Using the 56 Case-Patients with Estimated Dates of Onset and 56 Controls, March 2000July 2001 Review of Infection-Control Practices Our i

Hepatitis C Virus Infections from Unsafe Injection Practices at an Endoscopy Clinic in Las Vegas, Nevada, 2007–2008

BACKGROUND In January 2008, 3 persons with acute hepatitis C who all underwent endoscopy at a single facility in Nevada were identified. METHOD We reviewed clinical and laboratory data from initially detected cases of acute hepatitis C and reviewed infection control practices at the clinic where case patients underwent endoscopy. Persons who underwent procedures on days when the case patients underwent endoscopy were tested for hepatitis C virus (HCV) infection and other bloodborne pathogens. Quasispecies analysis determined the relatedness of HCV in persons infected. RESULTS In addition to the 3 initial cases, 5 additional cases of clinic-acquired HCV infection were identified from 2 procedure dates included in this initial field investigation. Quasispecies analysis revealed 2 distinct clusters of clinic-acquired HCV infections and a source patient related to each cluster, suggesting separate transmission events. Of 49 HCV-susceptible persons whose procedures followed that of the source patient on 25 July 2007, 1 (2%) was HCV infected. Among 38 HCV-susceptible persons whose procedures followed that of another source patient on 21 September 2007, 7 (18%) were HCV infected. Reuse of syringes on single patients in conjunction with use of single-use propofol vials for multiple patients was observed during normal clinic operations. CONCLUSIONS Patient-to-patient transmission of HCV likely resulted from contamination of single-use medication vials that were used for multiple patients during anesthesia administration. The resulting public health notification of approximately 50,000 persons was the largest of its kind in United States health care. This investigation highlighted breaches in aseptic technique, deficiencies in oversight of outpatient settings, and difficulties in detecting and investigating such outbreaks.

Infection Control Assessment of Ambulatory Surgical Centers

CONTEXT More than 5000 ambulatory surgical centers (ASCs) in the United States participate in the Medicare program. Little is known about infection control practices in ASCs. The Centers for Medicare & Medicaid Services (CMS) piloted an infection control audit tool in a sample of ASC inspections to assess facility adherence to recommended practices. OBJECTIVE To describe infection control practices in a sample of ASCs. DESIGN, SETTING, AND PARTICIPANTS All State Survey Agencies were invited to participate. Seven states volunteered; 3 were selected based on geographic dispersion, number of ASCs each state committed to inspect, and relative cost per inspection. A stratified random sample of ASCs was selected from each state. Sample size was based on the number of inspections each state estimated it could complete between June and October 2008. Sixty-eight ASCs were assessed; 32 in Maryland, 16 in North Carolina, and 20 in Oklahoma. Surveyors from CMS, trained in use of the audit tool, assessed compliance with specific infection control practices. Assessments focused on 5 areas of infection control: hand hygiene, injection safety and medication handling, equipment reprocessing, environmental cleaning, and handling of blood glucose monitoring equipment. MAIN OUTCOME MEASURES Proportion of facilities with lapses in each infection control category. RESULTS Overall, 46 of 68 ASCs (67.6%; 95% confidence interval [CI], 55.9%-77.9%) had at least 1 lapse in infection control; 12 of 68 ASCs (17.6%; 95% CI, 9.9%-28.1%) had lapses identified in 3 or more of the 5 infection control categories. Common lapses included using single-dose medication vials for more than 1 patient (18/64; 28.1%; 95% CI, 18.2%-40.0%), failing to adhere to recommended practices regarding reprocessing of equipment (19/67; 28.4%; 95% CI, 18.6%-40.0%), and lapses in handling of blood glucose monitoring equipment (25/54; 46.3%; 95% CI, 33.4%-59.6%). CONCLUSION Among a sample of US ASCs in 3 states, lapses in infection control were common.

A large nosocomial outbreak of hepatitis C and hepatitis B among patients receiving pain remediation treatments.

BACKGROUND AND OBJECTIVE In August 2002, the Oklahoma State Department of Health received a report of six patients with unexplained hepatitis C virus (HCV) infection treated in the same pain remediation clinic. We investigated the outbreaks extent and etiology. DESIGN, SETTING, AND PARTICIPANTS We conducted a retrospective cohort study of clinic patients, including a serologic survey, interviews of infected patients, and reviews of medical records and staff infection control practices. Patients received outpatient pain remediation treatments one afternoon a week in a clinic within a hospital. Cases were defined as HCV or hepatitis B virus (HBV) infections among patients who reported no prior diagnosis or risk factors for disease or reported previous risk factors but had evidence of acute infection. RESULTS Of 908 patients, 795 (87.6%) were tested, and 71 HCV-infected patients (8.9%) and 31 HBV-infected patients (3.9%) met the case definition. Multiple HCV genotypes were identified. Significantly higher HCV infection rates were found among individuals treated after an HCV-infected patient during the same visit (adjusted odds ratio [AOR], 6.2; 95% confidence interval [CI95], 2.4-15.8); a similar association was observed for HBV (AOR, 2.9; CI95, 1.3-6.5). Review of staff practices revealed the nurse anesthetist had been using the same syringe-needle to sequentially administer sedation medications to every treated patient each clinic day. CONCLUSIONS Reuse of needles-syringes was the mechanism for patient-to-patient transmission of HCV and HBV in this large nosocomial outbreak. Further education and stricter oversight of infection control practices may prevent future outbreaks.

Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies

Background: As part of routine diabetes care, capillary blood is typically sampled using a finger-stick device and then tested using a handheld blood glucose meter. In settings where multiple persons require assistance with blood glucose monitoring, opportunities for bloodborne pathogen transmission may exist. Methods: Reports of hepatitis B virus (HBV) infection outbreaks in the United States that have been attributed to blood glucose monitoring practices were reviewed and summarized. Results: Since 1990, state and local health departments investigated 18 HBV infection outbreaks, 15 (83%) in the past 10 years, that were associated with the improper use of blood glucose monitoring equipment. At least 147 persons acquired HBV infection during these outbreaks, 6 (4.1%) of whom died from complications of acute HBV infection. Outbreaks appear to have become more frequent in the past decade, primarily affecting long-term care residents with diabetes. Each outbreak was attributed to glucose monitoring practices that exposed HBV-susceptible persons to blood-contaminated equipment that was previously used on HBV-infected persons. The predominant unsafe practices were the use of spring-loaded finger-stick devices on multiple persons and the sharing of blood glucose testing meters without cleaning and disinfection between uses. Conclusion: Hepatitis B virus infection outbreaks associated with blood glucose monitoring have occurred with increasing regularity in the Unites States and may represent a growing but under-recognized problem. Advances in technology, such as the development of blood glucose testing meters that can withstand frequent disinfection and noninvasive glucose monitoring methods, will likely prove useful in improving patient safety.

US Outbreak Investigations Highlight the Need for Safe Injection Practices and Basic Infection Control

Current understanding of viral hepatitis transmission in United States health care settings indicates progress over the past several decades with respect to the risks from transfusions or blood products. Likewise, risks to health care providers from sharps injuries and other blood and body fluid exposures have been reduced as a consequence of widespread hepatitis B vaccination and the adoption of safer work practices. Increasing recognition of outbreaks involving patient-to-patient spread of hepatitis B and hepatitis C virus infections, however, has uncovered a disturbing trend. This article highlights the importance of basic infection control and the need for increased awareness of safe injection practices.

Multiple Clusters of Hepatitis Virus Infections Associated With Anesthesia for Outpatient Endoscopy Procedures

BACKGROUND & AIMS Hepatitis B virus (HBV) and hepatitis C virus (HCV) can be transmitted during administration of intravenous anesthesia when medication vials are used for multiple patients using incorrect technique. We investigated an outbreak of acute HBV and HCV infections among patients who received anesthesia during endoscopy procedures from the same anesthesiologist (anesthesiologist 1), in 2 different gastroenterology clinics. METHODS Chart reviews, patient interviews, clinic site visits and infection control assessments, and molecular sequencing of patient isolates were performed. Patients treated by anesthesiologist 1 on specific procedure days were offered testing for blood-borne pathogens. Endoscopy and anesthesia procedures were reviewed; HCV quasispecies analysis was performed. RESULTS Six cases of outbreak-associated HCV infection and 6 cases of outbreak-associated HBV infection were identified in clinic 1. One outbreak-associated HCV infection was identified in clinic 2. HCV quasispecies sequences from the patients were nearly identical (96.9%-100%) to those from source patients with chronic viral hepatitis. All affected patients in both clinics received propofol from anesthesiologist 1, who inappropriately used a single-patient-use vial of propofol for multiple patients. Reuse of syringes to redose patients, with resulting contamination of medication vials used for subsequent patients, likely resulted in viral transmission. CONCLUSIONS Twelve persons acquired HBV and HCV infections (6 hepatitis C, 5 hepatitis B, and 1 coinfection) in 2 separate offices as a result of receiving anesthesia from anesthesiologist 1. Gastroenterologists are urged to review carefully the injection, medication handling, and other infection control practices of all staff under their supervision, including providers of anesthesia services.

A large outbreak of hepatitis B virus infections associated with frequent injections at a physician's office.

OBJECTIVES To determine whether hepatitis B virus (HBV) transmission occurred among patients visiting a physicians office and to evaluate potential transmission mechanisms. DESIGN Serologic survey, retrospective cohort study, and observation of infection control practices. SETTING Private medical office. PATIENTS Those visiting the office between March 1 and December 26, 2001. RESULTS We identified 38 patients with acute HBV infection occurring between February 2000 and February 2002. The cohort study, limited to the 10 months before outbreak detection, included 91 patients with serologic test results and available charts representing 18 case-patients and 73 susceptible patients. Overall, 67 patients (74%) received at least one injection during the observation period. Case-patients received a median of 14 injections (range, 2-25) versus 2 injections (range, 0-17) for susceptible patients (P < .001). Acute infections occurred among 18 (27%) of 67 who received at least one injection versus none of 24 who received no injections (RR, 13.6; CI95, 2.4-undefined). Risk of infection increased 5.2-fold (CI95, 0.6-47.3) for those with 3 to 6 injections and 20.0-fold (CI95, 2.8-143.5) for those with more than 6 injections. Typically, injections consisted of doses of atropine, dexamethasone, vitamin B12, or a combination of these mixed in one syringe. HBV DNA genetic sequences of 24 patients with acute infection and 4 patients with chronic infection were identical in the 1,500-bp region examined. Medical staff were seronegative for HBV infection markers. The same surface was used for storing multidose vials, preparing injections, and dismantling used injection equipment. CONCLUSION Administration of unnecessary injections combined with failure to separate clean from contaminated areas and follow safe injection practices likely resulted in patient-to-patient HBV transmission in a private physicians office.

Near Elimination of Hepatitis B Virus Infections Among Hawaii Elementary School Children After Universal Infant Hepatitis B Vaccination

OBJECTIVES. Hawaii implemented routine infant hepatitis B vaccination in 1992 and required it for school entry in 1997. Previously, in 1989, a serologic survey among Hawaii school children in grades 1 to 3 indicated that 1.6% had chronic hepatitis B virus infection, and 2.1% had resolved infection. We conducted a follow-up survey to examine changes in hepatitis B virus infection rates. PATIENTS AND METHODS. This study was performed in Oahu, Hawaii, during the 2001–2002 school year among children in grades 2 and 3. Consenting parents/guardians provided demographic information including place of birth. Participants were tested for serologic evidence of hepatitis B virus infection and their vaccination status was determined by reviewing school records. Rates of symptomatic acute hepatitis B among persons aged ≤19 years were calculated from cases reported from Hawaii to the Centers for Disease Control and Prevention between 1990 and 2004. RESULTS. Completed hepatitis B vaccination series were documented for 83% of the 2469 participants by age 18 months and for 97% by age 5 years. Past or present hepatitis B virus infection was detected among 6 participants (0.24%), including 1 (0.04%) with chronic infection and 5 (0.20%) with resolved infections. Compared with the 1989 survey, these prevalences represent declines of 97% and 90% in chronic and resolved hepatitis B virus infections, respectively. The incidence of symptomatic acute hepatitis B in Hawaii children and adolescents aged ≤19 years decreased from 4.5 cases per 100000 in 1990 to 0.0 during 2002–2004. To date, the last reported case in a child aged <15 years in Hawaii occurred in 1996. CONCLUSIONS.. Hepatitis B virus infection has nearly been eliminated in Hawaii children born after universal infant hepatitis B vaccination was implemented. These findings suggest that hepatitis B prevention goals are being met through routine immunization and related prevention programs among US children.