In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to firstname.lastname@example.org.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.
National Healthcare Safety Network (NHSN) (OMB No. 0920-0666) exp. 05/31/2014—Revision—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of Start Printed Page 56459adverse events resulting from new and current medical therapies and changing risks. The NHSN previously consisted of four components: Patient Safety, Healthcare Personnel Safety, Biovigilance, and eSurveillance. In addition, a fifth component, Long Term Care Facilities (LTCF) is included in this revision. In general, the data reported under the Patient Safety Component protocols are used to (1) determine the magnitude of the healthcare-associated adverse events under study, trends in the rates of events, in the distribution of pathogens, and in the adherence to prevention practices, and (2) to detect changes in the epidemiology of adverse events resulting from new medical therapies and changing patient risks. Additionally, reported data will be used to describe the epidemiology of antimicrobial use and resistance and to understand the relationship of antimicrobial therapy to this growing problem. Under the Healthcare Personnel Safety Component protocols, data on events—both positive and adverse—are used to determine (1) the magnitude of adverse events in healthcare personnel and (2) compliance with immunization and sharps injuries safety guidelines. Under the Biovigilance Component, data on adverse reactions and incidents associated with blood transfusions are used to provide national estimates of adverse reactions and incidents. The Long-Term Care Facility (LTCF) Component will be used to more specifically and appropriately capture data from the residents of skilled nursing facilities. In order to facilitate this reporting, seven LTCF forms were created by using forms from the Patient Safety Component as a base, with modifications to specifically address the nuances of LTC residents.
This revision submission includes the remaining three LTCF Component forms needed to facilitate healthcare-associated infection (HAI) surveillance in this setting, for which no standardized reporting methodology or mechanism currently exists. The three submitted LTCF forms along with the four previously approved LTCF forms will complete the LTCF Component. The scope of NHSN dialysis surveillance is being expanded to include all outpatient dialysis centers, so that the existing Dialysis Annual Survey can be used to facilitate prevention objectives set forth in the HHS HAI tier 2 Action Plan and to assess national practices in all Medicare-certified dialysis centers if CMS re-establishes this survey method (as expected). In addition, two new annual facility surveys will be added for Long-term Acute Care Hospitals (LTAC) and Rehabilitation Hospitals (REHAB). A CMS ruling states that these specific hospital types must begin reporting HAI surveillance. Therefore, in order to accurately capture data relevant to those specific facility types, separate annual facility surveys were created. Also within the Patient Safety Component, a new form will be added, Streamlined Ventilator-Associated Pneumonia, to provide a streamlined, objective definition via which NHSN users may detect and report cases of ventilator-associated pneumonia in adult patients only. Finally there are many updates, clarifications, and data collection revisions proposed in this submission.
The previously approved NSHN package included 48 individual collection forms; the current revision request includes six new forms for a total of 54 forms. The reporting burden will increase by 64,050 hours, for a total of 3,978,175 hours.
Healthcare institutions that participate in NHSN voluntarily report their data to CDC using a Web browser based technology for data entry and data management. Data are collected by trained surveillance personnel using written standardized protocols. Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. There is no cost to respondents other than their time.
|Form number and name||Type of respondents||Number of respondents||Number of responses per respondent||Avg. burden per response (in hours)||Total burden (in hours)|
|57.100: NHSN Registration Form||Registered Nurse (Infection Preventionist)||6,000||1||5/60||500|
|57.101: Facility Contact Information||Registered Nurse (Infection Preventionist)||6,000||1||10/60||1,000|
|57.103: Patient Safety Component—Annual Facility Survey||Registered Nurse (Infection Preventionist)||6,000||1||30/60||3,000|
|57.104: Patient Safety Component—Outpatient Dialysis Center Practices Survey||Registered Nurse (Infection Preventionist)||5,500||1||1||5,500|
|57.105: Group Contact Information||Registered Nurse (Infection Preventionist)||6,000||1||5/60||500|
|57.106: Patient Safety Monthly Reporting Plan||Registered Nurse (Infection Preventionist)||6,000||9||35/60||31,500|
|57.108: Primary Bloodstream Infection (BSI)||Registered Nurse (Infection Preventionist)||6,000||36||33/60||118,800|
|57.109: Dialysis Event||Staff RN||5,500||75||16/60||110,000|
|57.111: Pneumonia (PNEU)||Registered Nurse (Infection Preventionist)||6,000||72||32/60||230,400|
|57.112: Streamlined Ventilator-Associated Pneumonia||Registered Nurse (Infection Preventionist)||6,000||144||25/60||360,000|
|57.114: Urinary Tract Infection (UTI)||Registered Nurse (Infection Preventionist)||6,000||27||32/60||86,400|
|57.116: Denominators for Neonatal Intensive Care Unit (NICU)||Staff RN||6,000||9||3||162,000|
|57.117: Denominators for Specialty Care Area (SCA)||Staff RN||6,000||9||5||270,000|
|57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)||Staff RN||6,000||18||5||540,000|
|Start Printed Page 56460|
|57.119: Denominator for Outpatient Dialysis||Staff RN||5,500||12||6/60||6,600|
|57.120: Surgical Site Infection (SSI)||Registered Nurse (Infection Preventionist)||6,000||36||32/60||115,200|
|57.121: Denominator for Procedure||Staff RN||6,000||540||8/60||432,000|
|57.123: Antimicrobial Use and Resistance (AUR)—Microbiology Data Electronic Upload Specification Tables||Laboratory Technician||6,000||12||5/60||6,000|
|57.124: Antimicrobial Use and Resistance (AUR)—Pharmacy Data Electronic Upload Specification Tables||Pharmacy Technician||6,000||12||5/60||6,000|
|57.125: Central Line Insertion Practices Adherence Monitoring||Registered Nurse (Infection Preventionist)||1,000||100||5/60||8,333|
|57.126: MDRO or CDI Infection Form||Registered Nurse (Infection Preventionist)||6,000||72||32/60||230,400|
|57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring||Registered Nurse (Infection Preventionist)||6,000||24||10/60||24,000|
|57.128: Laboratory-identified MDRO or CDI Event||Registered Nurse (Infection Preventionist)||6,000||240||15/60||360,000|
|57.130: Vaccination Monthly Monitoring Form—Summary Method||Registered Nurse (Infection Preventionist)||6,000||5||14||420,000|
|57.131: Vaccination Monthly Monitoring Form—Patient-Level Method||Registered Nurse (Infection Preventionist)||2,000||5||2||20,000|
|57.133: Patient Vaccination||Registered Nurse (Infection Preventionist)||2,000||250||10/60||83,333|
|57.137: Patient Safety Component—Annual Facility Survey for LTCF||Registered Nurse (Infection Preventionist)||250||1||25/60||104|
|57.138: Laboratory-identified MDRO or CDI Event for LTCF||Registered Nurse (Infection Preventionist)||250||8||15/60||500|
|57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF||Registered Nurse (Infection Preventionist)||250||3||5/60||63|
|57.140: Urinary Tract Infection (UTI) for LTCF||Registered Nurse (Infection Preventionist)||250||9||30/60||1,125|
|57.141: Monthly Reporting Plan for LTCF||Registered Nurse (Infection Preventionist)||250||12||5/60||250|
|57.142: Denominators for LTCF Locations||Registered Nurse (Infection Preventionist)||250||12||3||9,000|
|57.143: Prevention Process Measures Monthly Monitoring for LTCF||Registered Nurse (Infection Preventionist)||250||12||5/60||250|
|57.150: LTAC Annual Survey||Registered Nurse (Infection Preventionist)||400||1||30/60||200|
|57.151: Rehab Annual Survey||Registered Nurse (Infection Preventionist)||1,000||1||25/60||417|
|57.200: Healthcare Personnel Safety Component Annual Facility Survey||Occupational Health RN/Specialist||6,000||1||8||48,000|
|57.202: Healthcare Worker Survey||Occupational Health RN/Specialist||600||100||10/60||10,000|
|57.203: Healthcare Personnel Safety Monthly Reporting Plan||Occupational Health RN/Specialist||600||9||10/60||900|
|57.204: Healthcare Worker Demographic Data||Occupational Health RN/Specialist||600||200||20/60||40,000|
|57.205: Exposure to Blood/Body Fluids||Occupational Health RN/Specialist||600||50||1||30,000|
|57.206: Healthcare Worker Prophylaxis/Treatment||Occupational Health RN/Specialist||600||10||15/60||1,500|
|57.207: Follow-Up Laboratory Testing||Laboratory Technician||600||100||15/60||15,000|
|57.208: Healthcare Worker Vaccination History||Occupational Health RN/Specialist||600||300||10/60||30,000|
|57.209: Healthcare Worker Influenza Vaccination||Occupational Health RN/Specialist||600||500||10/60||50,000|
|57.210: Healthcare Worker Prophylaxis/Treatment—Influenza||Occupational Health RN/Specialist||600||50||10/60||5,000|
|57.211: Pre-season Survey on Influenza Vaccination Programs for Healthcare Personnel||Occupational Health RN/Specialist||600||1||10/60||100|
|Start Printed Page 56461|
|57.212: Post-season Survey on Influenza Vaccination Programs for Healthcare Personnel||Occupational Health RN/Specialist||600||1||10/60||100|
|57.213: Healthcare Personnel Influenza Vaccination Monthly Summary||Occupational Health RN/Specialist||6,000||6||2||72,000|
|57.300: Hemovigilance Module Annual Survey||Medical/Clinical Laboratory Technologist||500||1||2||1,000|
|57.301: Hemovigilance Module Monthly Reporting Plan||Medical/Clinical Laboratory Technologist||500||12||2/60||200|
|57.302: Hemovigilance Module Monthly Incident Summary||Medical/Clinical Laboratory Technologist||500||12||2||12,000|
|57.303: Hemovigilance Module Monthly Reporting Denominators||Medical/Clinical Laboratory Technologist||500||12||30/60||3,000|
|57.304: Hemovigilance Adverse Reaction||Medical/Clinical Laboratory Technologist||500||120||10/60||10,000|
|57.305: Hemovigilance Incident||Medical/Clinical Laboratory Technologist||500||72||10/60||6,000|
Total Est Annual Burden Hours: 3,978,175Start Signature
Dated: September 6, 2011.
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-23302 Filed 9-12-11; 8:45 am]
BILLING CODE 4163-18-P