2015-16028. Proposed Data Collection Submitted for Public Comment and Recommendations

AGENCY:

Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

ACTION:

Notice with comment period.

SUMMARY:

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Healthcare Safety Network (NHSN). 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.

DATES:

Written comments must be received on or before August 31, 2015.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2015-0048 by any of the following methods:

• Federal eRulemaking Portal: Regulation.gov. Follow the instructions for submitting comments.
• Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

Please note:

All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: [phone]; Email: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

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; (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; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

Proposed Project

National Healthcare Safety Network (NHSN)—Revision—National Center for Emerging and Zoonotic Infection 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 currently consists of five components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), and Dialysis. The Outpatient Procedure Component is on track to be released in NHSN in 2016/2017. The development of this component has been previously delayed to obtain additional user feedback and support from outside partners.

Changes were made to seven facility surveys. Based on user feedback and internal reviews of the annual facility surveys it was determined that questions and response options be amended, removed, or added to fit the evolving uses of the annual facility surveys. The surveys are being increasingly used to help intelligently interpret the other data elements reported into NHSN. Currently the surveys are used to appropriately risk adjust the numerator and denominator data entered into NHSN while also guiding decisions on future division priorities for prevention.

Additionally, minor revisions have been made to 27 forms within the package to clarify and/or update surveillance definitions. Two forms are being removed as those forms will no longer be added to the NHSN system. The previously approved NHSN package included 54 individual collection forms; the current revision request removes two forms for a total of 52 forms. The reporting burden will increase by 583,825 hours, for a total of 4,861,542 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Registered Nurse (Infection Preventionist)	NHSN Registration Form	2,000	1	5/60	167
Registered Nurse (Infection Preventionist)	Facility Contact Information	2,000	1	10/60	333
Registered Nurse (Infection Preventionist)	Patient Safety Component—Annual Hospital Survey	5,000	1	50/60	4,167
Registered Nurse (Infection Preventionist)	Group Contact Information	1,000	1	5/60	83
Registered Nurse (Infection Preventionist)	Patient Safety Monthly Reporting Plan	6,000	12	15/60	18,000
Registered Nurse (Infection Preventionist)	Primary Bloodstream Infection (BSI)	6,000	44	30/60	132,000
Registered Nurse (Infection Preventionist)	Pneumonia (PNEU)	6,000	72	30/60	216,000
Registered Nurse (Infection Preventionist)	Ventilator-Associated Event	6,000	144	25/60	360,000
Registered Nurse (Infection Preventionist)	Urinary Tract Infection (UTI)	6,000	40	20/60	80,000
Staff RN	Denominators for Neonatal Intensive Care Unit (NICU)	6,000	9	3	162,000
Staff RN	Denominators for Specialty Care Area (SCA)/Oncology (ONC)	6,000	9	5	270,000
Staff RN	Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)	6,000	60	5	1,800,000
Registered Nurse (Infection Preventionist)	Surgical Site Infection (SSI)	6,000	36	35/60	126,000
Staff RN	Denominator for Procedure	6,000	540	5/60	270,000
Laboratory Technician	Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables	6,000	12	5/60	6,000
Pharmacy Technician	Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables	6,000	12	5/60	6,000
Registered Nurse (Infection Preventionist)	Central Line Insertion Practices Adherence Monitoring	1,000	100	25/60	41,667
Registered Nurse (Infection Preventionist)	MDRO or CDI Infection Form	6,000	72	30/60	216,000
Registered Nurse (Infection Preventionist)	MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	6,000	24	15/60	36,000
Registered Nurse (Infection Preventionist)	Laboratory-identified MDRO or CDI Event	6,000	240	30/60	720,000
Registered Nurse (Infection Preventionist)	Long-Term Care Facility Component—Annual Facility Survey	250	1	1	250
Registered Nurse (Infection Preventionist)	Laboratory-identified MDRO or CDI Event for LTCF	250	8	15/60	500
Registered Nurse (Infection Preventionist)	MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	250	12	5/60	250
Registered Nurse (Infection Preventionist)	Urinary Tract Infection (UTI) for LTCF	250	9	30/60	1,125
Registered Nurse (Infection Preventionist)	Monthly Reporting Plan for LTCF	250	12	5/60	250
Registered Nurse (Infection Preventionist)	Denominators for LTCF Locations	250	12	3.25	9,750
Registered Nurse (Infection Preventionist)	Prevention Process Measures Monthly Monitoring for LTCF	250	12	5/60	250
Registered Nurse (Infection Preventionist)	LTAC Annual Survey	400	1	50/60	333
Registered Nurse (Infection Preventionist)	Rehab Annual Survey	1,000	1	50/60	833
Occupational Health RN/Specialist	Healthcare Personnel Safety Component Annual Facility Survey	50	1	8	400
Occupational Health RN/Specialist	Healthcare Personnel Safety Monthly Reporting Plan	17,000	1	5/60	1,417
Occupational Health RN/Specialist	Healthcare Worker Demographic Data	50	200	20/60	3,333
Occupational Health RN/Specialist	Exposure to Blood/Body Fluids	50	50	1	2,500
Occupational Health RN/Specialist	Healthcare Worker Prophylaxis/Treatment	50	30	15/60	375
Laboratory Technician	Follow-Up Laboratory Testing	50	50	15/60	625
Occupational Health RN/Specialist	Healthcare Worker Prophylaxis/Treatment-Influenza	50	50	10/60	417
Medical/Clinical Laboratory Technologist	Hemovigilance Module Annual Survey	500	1	2	1,000
Medical/Clinical Laboratory Technologist	Hemovigilance Module Monthly Reporting Plan	500	12	1/60	100
Medical/Clinical Laboratory Technologist	Hemovigilance Module Monthly Reporting Denominators	500	12	1	6,000
Medical/Clinical Laboratory Technologist	Hemovigilance Adverse Reaction	500	48	15/60	6,000
Medical/Clinical Laboratory Technologist	Hemovigilance Incident	500	10	10/60	833
Staff RN	Patient Safety Component—Annual Facility Survey for Ambulatory Surgery Center (ASC)	5,000	1	5/60	417
Staff RN	Outpatient Procedure Component—Monthly Reporting Plan	5,000	12	15/60	15,000
Staff RN	Outpatient Procedure Component Event	5,000	25	40/60	83,333
Staff RN	Outpatient Procedure Component—Monthly Denominators and Summary	5,000	12	40/60	40,000
Registered Nurse (Infection Preventionist)	Outpatient Dialysis Center Practices Survey	6,500	1	2.0	13,000
Staff RN	Dialysis Monthly Reporting Plan	6,500	12	5/60	6,500
Staff RN	Dialysis Event	6,500	60	25/60	162,500
Staff RN	Denominators for Dialysis Event Surveillance	6,500	12	10/60	13,000
Staff RN	Prevention Process Measures Monthly Monitoring for Dialysis	1,500	12	1.25	22,500
Staff RN	Dialysis Patient Influenza Vaccination	325	75	10/60	4,063
Staff RN	Dialysis Patient Influenza Vaccination Denominator	325	5	10/60	271
Total					4,861,542

Maryam I. Daneshvar,

Deputy Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.