2013-14752. 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 [e-mail].

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.

Estimated Annualized Burden 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.