2011-23302. 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 404-639-5960 and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [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. 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 adverse 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.

Estimate of Annualized Burden Hours

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
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
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: 3,978,175

Dated: September 6, 2011.

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.