78 FR 119 pgs. 37224-37226 - Proposed Data Collections Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 78Number: 119Pages: 37224 - 37226
Docket number: [60-Day-13-0666]
FR document: [FR Doc. 2013-14752 Filed 6-19-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-13-0666]
Proposed Data Collections Submitted for Public Comment and Recommendations
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 404-639-7570 or send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to omb@cdc.gov.
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.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp. 12/31/2015-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 adverse events resulting from new and current medical therapies and changing risks. The NHSN consists of six components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), Dialysis, and Outpatient Procedure.
The new Dialysis Component was developed in order to separate reporting of dialysis events from the Patient Safety Component. The new component will tailor the NHSN user interface for dialysis users to simplify their data entry and analyses processes as well as provide options for expanding the Dialysis Component in the future to include dialysis surveillance in settings other than outpatient facilities.
The new Outpatient Procedure Component was developed to gather data on the impact of infections and other outcomes related to outpatient procedures that are performed in settings such as Ambulatory Surgery Centers (ASCs), Hospital Outpatient Departments (HOPDs), and physicians' offices. Three event types will be monitored in this new component: Same Day Outcome Measures, Prophylactic Intravenous (IV) Antibiotic Timing, and Surgical Site Infections (SSI).
This revision submission includes two new NHSN components and their corresponding forms. The Dialysis Component consists of changes to three previously approved forms and the addition of four new forms. These new forms include component specific monthly reporting plan, prevention process measures monthly monitoring, patient influenza vaccination, and patient influenza vaccination denominator forms. The Outpatient Procedure Component consists of four new forms: component specific annual survey, monthly reporting plan, event, and monthly denominators and summary forms.
Further, the breadth of organism susceptibility data required on all of the healthcare-associated infection (HAI) report forms (i.e., BSI, UTI, SSI, PNEU (VAP and VAE), DE, LTUTI, and MDRO Infection Surveillance) has been reduced for the purposes of streamlining, simplification, and removing undue burden where possible. Significant changes were made to the NHSN Biovigilance Component forms as a result of a subject matter expert and stakeholder working groups. This includes the removal of the monthly incident summary form. A brand new form was added (Form 57.600-State Health Department Validation Record) to collect aggregate validation results that will be gathered by state health departments when conducting facility-level validation of NHSN healthcare-associated infection (HAI) data within their jurisdictions using the CDC/NHSN Validation Guidance and Toolkits.
Additionally, minor revisions have been made to 17 other forms within the package to clarify and/or update surveillance definitions.
The previously approved NSHN package included 48 individual collection forms; the current revision request adds nine new forms and removes one form for a total of 56 forms. The reporting burden will increase by 542,123 hours, for a total of 4,104,776 hours.
| Type of respondents | Form number and name | Number of respondents | Number of responses per respondent | Average burden per response (in hrs.) | Total burden (in hrs.) |
|---|---|---|---|---|---|
| Registered Nurse (Infection Preventionist) | 57.100: NHSN Registration Form | 2,000 | 1 | 5/60 | 167 |
| Registered Nurse (Infection Preventionist) | 57.101: Facility Contact Information | 2,000 | 1 | 10/60 | 333 |
| Registered Nurse (Infection Preventionist) | 57.103: Patient Safety Component-Annual Hospital Survey | 6,000 | 1 | 30/60 | 3,000 |
| Registered Nurse (Infection Preventionist) | 57.105: Group Contact Information | 6,000 | 1 | 5/60 | 500 |
| Registered Nurse (Infection Preventionist) | 57.106: Patient Safety Monthly Reporting Plan | 6,000 | 12 | 35/60 | 42,000 |
| Registered Nurse (Infection Preventionist) | 57.108: Primary Bloodstream Infection (BSI) | 6,000 | 36 | 32/60 | 115,200 |
| Registered Nurse (Infection Preventionist) | 57.111: Pneumonia (PNEU) | 6,000 | 72 | 29/60 | 208,800 |
| Registered Nurse (Infection Preventionist) | 57.112: Ventilator-Associated Event | 6,000 | 144 | 22/60 | 316,800 |
| Infection Preventionist | 57.114: Urinary Tract Infection (UTI) | 6,000 | 27 | 29/60 | 78,300 |
| Staff RN | 57.116: Denominators for Neonatal Intensive Care Unit (NICU) | 6,000 | 9 | 3 | 162,000 |
| Staff RN | 57.117: Denominators for Specialty Care Area (SCA)/Oncology (ONC) | 6,000 | 9 | 5 | 270,000 |
| Staff RN | 57.118: Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) | 6,000 | 54 | 5 | 1,620,000 |
| Registered Nurse (Infection Preventionist) | 57.120: Surgical Site Infection (SSI) | 6,000 | 36 | 29/60 | 104,400 |
| Staff RN | 57.121: Denominator for Procedure | 6,000 | 540 | 5/60 | 270,000 |
| Laboratory Technician | 57.123: Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables | 6,000 | 12 | 5/60 | 6,000 |
| Pharmacy Technician | 57.124: Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables | 6,000 | 12 | 5/60 | 6,000 |
| Registered Nurse (Infection Preventionist) | 57.125: Central Line Insertion Practices Adherence Monitoring | 1,000 | 100 | 5/60 | 8,333 |
| Registered Nurse (Infection Preventionist) | 57.126: MDRO or CDI Infection Form | 6,000 | 72 | 29/60 | 208,800 |
| Registered Nurse (Infection Preventionist) | 57.127: MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring | 6,000 | 24 | 12/60 | 28,800 |
| Registered Nurse (Infection Preventionist) | 57.128: Laboratory-identified MDRO or CDI Event | 6,000 | 240 | 15/60 | 360,000 |
| Registered Nurse (Infection Preventionist) | 57.130: Vaccination Monthly Monitoring Form-Summary Method | 100 | 5 | 14 | 7,000 |
| Registered Nurse (Infection Preventionist) | 57.131: Vaccination Monthly Monitoring Form-Patient-Level Method | 100 | 5 | 2 | 1,000 |
| Registered Nurse (Infection Preventionist) | 57.133: Patient Vaccination | 100 | 250 | 10/60 | 4,167 |
| Registered Nurse (Infection Preventionist) | 57.137: Long-Term Care Facility Component-Annual Facility Survey | 250 | 1 | 45/60 | 188 |
| Registered Nurse (Infection Preventionist) | 57.138: Laboratory-identified MDRO or CDI Event for LTCF | 250 | 8 | 15/60 | 500 |
| Registered Nurse (Infection Preventionist) | 57.139: MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF | 250 | 12 | 5/60 | 250 |
| Registered Nurse (Infection Preventionist) | 57.140: Urinary Tract Infection (UTI) for LTCF | 250 | 9 | 27/60 | 1,013 |
| Registered Nurse (Infection Preventionist) | 57.141: Monthly Reporting Plan for LTCF | 250 | 12 | 5/60 | 250 |
| Registered Nurse (Infection Preventionist) | 57.142: Denominators for LTCF Locations | 250 | 12 | 3 | 9,000 |
| Registered Nurse (Infection Preventionist) | 57.143: Prevention Process Measures Monthly Monitoring for LTCF | 250 | 12 | 5/60 | 250 |
| Registered Nurse (Infection Preventionist) | 57.150: LTAC Annual Survey | 400 | 1 | 30/60 | 200 |
| Registered Nurse (Infection Preventionist) | 57.151: Rehab Annual Survey | 1,000 | 1 | 25/60 | 417 |
| Occupational Health RN/Specialist | 57.200: Healthcare Personnel Safety Component Annual Facility Survey | 50 | 1 | 8 | 400 |
| Occupational Health RN/Specialist | 57.203: Healthcare Personnel Safety Monthly Reporting Plan | 50 | 9 | 10/60 | 75 |
| Occupational Health RN/Specialist | 57.204: Healthcare Worker Demographic Data | 50 | 200 | 20/60 | 3,333 |
| Occupational Health RN/Specialist | 57.205: Exposure to Blood/Body Fluids | 50 | 50 | 1 | 2,500 |
| Occupational Health RN/Specialist | 57.206: Healthcare Worker Prophylaxis/Treatment | 50 | 30 | 15/60 | 375 |
| Laboratory Technician | 57.207: Follow-Up Laboratory Testing | 50 | 50 | 15/60 | 625 |
| Occupational Health RN/Specialist | 57.210: Healthcare Worker Prophylaxis/Treatment-Influenza | 50 | 50 | 10/60 | 417 |
| Medical/Clinical Laboratory Technologist | 57.300: Hemovigilance Module Annual Survey | 500 | 1 | 2 | 1,000 |
| Medical/Clinical Laboratory Technologist | 57.301: Hemovigilance Module Monthly Reporting Plan | 500 | 12 | 1/60 | 100 |
| Medical/Clinical Laboratory Technologist | 57.303: Hemovigilance Module Monthly Reporting Denominators | 500 | 12 | 1 | 6,000 |
| Medical/Clinical Laboratory Technologist | 57.304: Hemovigilance Adverse Reaction | 500 | 48 | 15/60 | 6,000 |
| Medical/Clinical Laboratory Technologist | 57.305: Hemovigilance Incident | 500 | 12 | 10/60 | 1,000 |
| Staff RN | 57.400: Outpatient Procedure Component-Annual Facility Survey | 5,000 | 1 | 5/60 | 417 |
| Staff RN | 57.401: Outpatient Procedure Component-Monthly Reporting Plan | 5,000 | 12 | 15/60 | 15,000 |
| Staff RN | 57.402: Outpatient Procedure Component Event | 5,000 | 25 | 40/60 | 83,333 |
| Staff RN | 57.403: Outpatient Procedure Component-Monthly Denominators and Summary | 5,000 | 12 | 40/60 | 40,000 |
| Registered Nurse (Infection Preventionist) | 57.500: Outpatient Dialysis Center Practices Survey | 6,000 | 1 | 1.75 | 10,500 |
| Staff RN | 57.501: Dialysis Monthly Reporting Plan | 6,000 | 12 | 5/60 | 6,000 |
| Staff RN | 57.502: Dialysis Event | 6,000 | 60 | 13/60 | 78,000 |
| Staff RN | 57.503: Denominator for Outpatient Dialysis | 6,000 | 12 | 6/60 | 7,200 |
| Staff RN | 57.504: Prevention Process Measures Monthly Monitoring for Dialysis | 600 | 12 | 30/60 | 3,600 |
| Staff RN | 57.505: Dialysis Patient Influenza Vaccination | 250 | 75 | 10/60 | 3,125 |
| Staff RN | 57.506: Dialysis Patient Influenza Vaccination Denominator | 250 | 5 | 10/60 | 208 |
| Epidemiologist | 57.600: State Health Department Validation Record | 152 | 50 | 15/60 | 1,900 |
| Total | 4,104,776 |
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director.
[FR Doc. 2013-14752 Filed 6-19-13; 8:45 am]
BILLING CODE 4163-18-P