Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project: Surveillance for Bloodstream and Vascular Access Infections in Outpatient Hemodialysis Centers, (OMB No. 0920-0442)—Extension—National Center for Infectious Diseases (NCID), Centers for Disease Control and Prevention (CDC).

CDC is proposing an extension of a surveillance survey of bloodstream infections, vascular access infections, infections caused by hospitalization, and antimicrobial infections, all of which starts at U.S. outpatient hemodialysis centers. Although bloodstream and vascular access infections are common in hemodialysis patients, prior to this system there was no previous system to record and track these complications.

Participation in the proposed project is voluntary. Currently about 80-90 centers report data each month. We estimate that about 100 of the approximately 4,500 U.S. outpatient hemodialysis centers will participate in the coming years.

Participating centers may collect data continuously, or may discontinue participation at any time. CDC estimates that the average center will participate for nine months. Each month, participating centers will record the number of hemodialysis patients they treat and maintain a log of all hospitalizations and intravenous (IV) antimicrobial starts. For each hospitalization or IV antimicrobial start, further information (e.g., type of vascular access, clinical symptoms, presence of a vascular access infection, and blood culture results) will be collected. These data may be reported to CDC on paper forms or via a secure Internet site. CDC aggregates this data and generates reports which are sent to participating dialysis centers.

Centers that participate in the Internet-based reporting system may also analyze their own data and print out reports as desired. Rates of bloodstream infection, vascular access infection, and antimicrobial use per 1,000 patient-days will be calculated. Also, the percentage of antimicrobial starts for which a blood culture is performed will be calculated. Through use of these data, dialysis centers will be able to track rates of key infectious complications of hemodialysis. This will facilitate quality control improvements to reduce the incidence of infections, and clinical practice guidelines to improve use of antimicrobials. The estimated annualized burden is 6,300 hours.