77 FR 144 pgs. 43828-43831 - Proposed Data Collections Submitted for Public Comment and Recommendations
Type: NOTICEVolume: 77Number: 144Pages: 43828 - 43831
Docket number: [60Day-12-0666]
FR document: [FR Doc. 2012-17987 Filed 7-25-12; 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
[60Day-12-0666]
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 and send comments to Kimberly S. Lane, CDC Reports Clearance Officer, 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. 01/31/2015-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 four components: Patient Safety, Healthcare Personnel Safety, Biovigilance, and Long-Term Care Facility (LTCF). 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 is used to more specifically and appropriately capture data from the residents of skilled nursing facilities. Surveillance methods and definitions for this component specifically address the nuances of LTCF residents.
This revision submission includes major revisions to the Patient Safety Component-Outpatient Dialysis Center Practices Survey (Form 57.104) in an effort to provide further clarification to those collecting the information. Additionally, some of the changes have been made to improve surveillance data available for the outpatient dialysis population. Due to the CMS End Stage Renal Disease (ESRD) Quality Improvement Program (QIP) reporting requirements, over 5,700 dialysis facilities have already enrolled or will enroll into NHSN to report data in 2012. Form 57.104 is completed by each facility upon enrollment into NHSN and then every January thereafter.
Furthermore, minor revisions have been made to 28 other forms within the package to clarify and/or update surveillance definitions. Six forms have been removed for the purposes of simplification from the Healthcare Personnel Safety Component of the package due to changes within NHSN reporting of healthcare personnel influenza vaccination. Old functionality of individual level vaccination reporting will be removed from NHSN. CMS Inpatient Quality Reporting (IQR) requirements designate that all acute care facilities will report healthcare personnel vaccination counts at the summary level for the 2012-2013 flu season.
The previously approved NSHN package included 54 individual collection forms; the current revision request removes six forms for a total of 48 forms. The reporting burden will decrease by 415,523 hours, for a total of 3,562,653 hours.
Healthcare institutions that participate in NHSN 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) | 2,000 | 1 | 5/60 | 167 |
| 57.101: Facility Contact Information | Registered Nurse (Infection Preventionist) | 2,000 | 1 | 10/60 | 333 |
| 57.103: Patient Safety Component-Annual Hospital 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) | 5,700 | 1 | 1.5 | 8,550 |
| 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) | 10,000 | 12 | 35/60 | 70,000 |
| 57.108: Primary Bloodstream Infection (BSI) | Registered Nurse (Infection Preventionist) | 6,000 | 36 | 35/60 | 126,000 |
| 57.109: Dialysis Event | Staff RN | 5,700 | 60 | 16/60 | 91,200 |
| 57.111: Pneumonia (PNEU) | Registered Nurse (Infection Preventionist) | 6,000 | 72 | 32/60 | 230,400 |
| 57.112: Ventilator-Associated Event | Registered Nurse (Infection Preventionist) | 6,000 | 144 | 25/60 | 360,000 |
| 57.114: Urinary Tract Infection (UTI) | 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)/Oncology (ONC) | 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 |
| 57.119: Denominator for Outpatient Dialysis | Staff RN | 5,700 | 12 | 6/60 | 6,840 |
| 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 | 5/60 | 270,000 |
| 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: Long-Term Care Facility Component-Annual Facility Survey | Registered Nurse (Infection Preventionist) | 250 | 1 | 45/60 | 188 |
| 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 | 12 | 5/60 | 250 |
| 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 | 100 | 1 | 8 | 800 |
| 57.203: Healthcare Personnel Safety Monthly Reporting Plan | Occupational Health RN/Specialist | 100 | 9 | 10/60 | 150 |
| 57.204: Healthcare Worker Demographic Data | Occupational Health RN/Specialist | 100 | 200 | 20/60 | 6,667 |
| 57.205: Exposure to Blood/Body Fluids | Occupational Health RN/Specialist | 100 | 50 | 1 | 5,000 |
| 57.206: Healthcare Worker Prophylaxis/Treatment | Occupational Health RN/Specialist | 100 | 30 | 15/60 | 750 |
| 57.207: Follow-Up Laboratory Testing | Laboratory Technician | 100 | 50 | 15/60 | 1,250 |
| 57.210: Healthcare Worker Prophylaxis/Treatment-Influenza | Occupational Health RN/Specialist | 600 | 50 | 10/60 | 5,000 |
| 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 | 3,562,653 |
Dated: July 3, 2012.
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2012-17987 Filed 7-25-12; 8:45 am]
BILLING CODE 4163-18-P