2017-20009. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on May 30, 2017 to obtain comments from the public and affected agencies. CDC received one comment related to the first notice. The purpose of this notice is to allow an additional 30 days for public comments.

Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. The Office of Management and Budget is particularly interested in comments that:

(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone] or send an email to [e-mail]. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB No. 0920-0666), exp. 11/30/2019—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, CDC uses the data 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. CDC will use the data 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. CDC will release the NHSN “Outpatient Procedure Component” in 2018. CDC's request for additional user feedback and support from outside partners delayed development of this component.

After receiving user feedback and internal review feedback, CDC made changes to six facility surveys. For the annual facility surveys, CDC amended, removed, or added questions and response options to fit the survey's evolving uses. In addition, CDC and its partners use the surveys 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.

Further, two new forms were added to expand NHSN surveillance to enhance data collection by Ambulatory Surgical Centers to identify areas where prevention of SSIs may be improved. CDC modified an additional 14 forms within the Hemovigilance module to streamline data collection/entry for adverse reaction events.

Overall, CDC has made minor revisions to a total of 44 forms within the package to clarify and/or update surveillance definitions, increase or decrease the number of reporting facilities, and adding 2 new forms. The previously approved NHSN information collection package included 70 individual collection forms; the current revision request includes 72 forms. The reporting burden will increase by 811,985 hours, for a total of 5,922,953 hours.

Estimated Annualized Burden Hours

Type of respondent	Form No. & name	Number of respondents	Number of responses per respondent	Average burden per response (hours)
Registered Nurse (Infection Preventionist)	57.100 NHSN Registration Form	2,000	1	5/60
Registered Nurse (Infection Preventionist)	57.101 Facility Contact Information	2,000	1	10/60
Registered Nurse (Infection Preventionist)	57.103 Patient Safety Component—Annual Hospital Survey	5,000	1	55/60
Registered Nurse (Infection Preventionist)	57.105 Group Contact Information	1,000	1	5/60
Registered Nurse (Infection Preventionist)	57.106 Patient Safety Monthly Reporting Plan	6,000	12	15/60
Registered Nurse (Infection Preventionist)	57.108 Primary Bloodstream Infection (BSI)	6,000	44	30/60
Registered Nurse (Infection Preventionist)	57.111 Pneumonia (PNEU)	6,000	72	30/60
Registered Nurse (Infection Preventionist)	57.112 Ventilator-Associated Event	6,000	144	25/60
Registered Nurse (Infection Preventionist)	57.113 Pediatric Ventilator-Associated Event (PedVAE)	2,000	120	25/60
Registered Nurse (Infection Preventionist)	57.114 Urinary Tract Infection (UTI)	6,000	40	20/60
Registered Nurse (Infection Preventionist)	57.115 Custom Event	2,000	91	35/60
Staff RN	57.116 Denominators for Neonatal Intensive Care Unit (NICU)	6,000	12	4
Staff RN	57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)	6,000	9	5
Staff RN	57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)	6,000	60	5
Registered Nurse (Infection Preventionist)	57.120 Surgical Site Infection (SSI)	6,000	36	35/60
Staff RN	57.121 Denominator for Procedure	6,000	540	10/60
Laboratory Technician	57.123 Antimicrobial Use and Resistance (AUR)—Microbiology Data Electronic Upload Specification Tables	6,000	12	5/60
Pharmacist	57.124 Antimicrobial Use and Resistance (AUR)—Pharmacy Data Electronic Upload Specification Tables	6,000	12	5/60
Registered Nurse (Infection Preventionist)	57.125 Central Line Insertion Practices Adherence Monitoring	100	100	25/60
Registered Nurse (Infection Preventionist)	57.126 MDRO or CDI Infection Form	6,000	72	30/60
Registered Nurse (Infection Preventionist)	57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring	6,000	24	15/60
Registered Nurse (Infection Preventionist)	57.128 Laboratory-identified MDRO or CDI Event	6,000	240	20/60
Registered Nurse (Infection Preventionist)	57.129 Adult Sepsis	50	250	25/60
Registered Nurse (Infection Preventionist)	57.137 Long-Term Care Facility Component—Annual Facility Survey	2,600	1	2
Registered Nurse (Infection Preventionist)	57.138 Laboratory-identified MDRO or CDI Event for LTCF	2,600	12	15/60
Registered Nurse (Infection Preventionist)	57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF	2,600	12	10/60
Registered Nurse (Infection Preventionist)	57.140 Urinary Tract Infection (UTI) for LTCF	2,600	14	30/60
Registered Nurse (Infection Preventionist)	57.141 Monthly Reporting Plan for LTCF	2,600	12	5/60
Registered Nurse (Infection Preventionist)	57.142 Denominators for LTCF Locations	2,600	12	4
Registered Nurse (Infection Preventionist)	57.143 Prevention Process Measures Monthly Monitoring for LTCF	2,600	12	5/60
Registered Nurse (Infection Preventionist)	57.150 LTAC Annual Survey	400	1	55/60
Registered Nurse (Infection Preventionist)	57.151 Rehab Annual Survey	1,000	1	55/60
Occupational Health RN/Specialist	57.200 Healthcare Personnel Safety Component Annual Facility Survey	50	1	8
Occupational Health RN/Specialist	57.203 Healthcare Personnel Safety Monthly Reporting Plan	17,000	1	5/60
Occupational Health RN/Specialist	57.204 Healthcare Worker Demographic Data	50	200	20/60
Occupational Health RN/Specialist	57.205 Exposure to Blood/Body Fluids	50	50	1
Occupational Health RN/Specialist	57.206 Healthcare Worker Prophylaxis/Treatment	50	30	15/60
Laboratory Technician	57.207 Follow-Up Laboratory Testing	50	50	15/60
Occupational Health RN/Specialist	57.210 Healthcare Worker Prophylaxis/Treatment-Influenza	50	50	10/60
Medical/Clinical Laboratory Technologist	57.300 Hemovigilance Module Annual Survey	500	1	2
Medical/Clinical Laboratory Technologist	57.301 Hemovigilance Module Monthly Reporting Plan	500	12	1/60
Medical/Clinical Laboratory Technologist	57.303 Hemovigilance Module Monthly Reporting Denominators	500	12	1.17
Medical/Clinical Laboratory Technologist	57.305 Hemovigilance Incident	500	10	10/60
Medical/Clinical Laboratory Technologist	57.306 Hemovigilance Module Annual Survey—Non-acute care facility	200	1	35/60
Medical/Clinical Laboratory Technologist	57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction	500	4	20/60
Medical/Clinical Laboratory Technologist	57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction	500	4	20/60
Medical/Clinical Laboratory Technologist	57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction	500	1	20/60
Medical/Clinical Laboratory Technologist	57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction	500	2	20/60
Medical/Clinical Laboratory Technologist	57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction	500	4	20/60
Medical/Clinical Laboratory Technologist	57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction	500	1	20/60
Medical/Clinical Laboratory Technologist	57.313 Hemovigilance Adverse Reaction—Infection	500	1	20/60
Medical/Clinical Laboratory Technologist	57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura	500	1	20/60
Medical/Clinical Laboratory Technologist	57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea	500	1	20/60
Medical/Clinical Laboratory Technologist	57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease	500	1	20/60
Medical/Clinical Laboratory Technologist	57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury	500	1	20/60
Medical/Clinical Laboratory Technologist	57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload	500	2	20/60
Medical/Clinical Laboratory Technologist	57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction	500	1	20/60
Medical/Clinical Laboratory Technologist	57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction	500	1	20/60
Medical/Clinical Laboratory Technologist	57.400 Patient Safety Component—Annual Facility Survey	5,000	1	5/60
Staff RN	57.401 Outpatient Procedure Component—Monthly Reporting Plan	5,000	12	15/60
Staff RN	57.402 Outpatient Procedure Component—Same Day Outcome Measures & Prophylactic Intravenous (IV) Antibiotic Timing Event	5,000	25	40/60
Staff RN	57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures & Prophylactic Intravenous (IV) Antibiotic Timing Event	5,000	12	40/60
Staff RN	57.404 Outpatient Procedure Component—Annual Facility Survey	5,000	540	10/60
Registered Nurse (Infection Preventionist)	57.405 Outpatient Procedure Component—Surgical Site (SSI) Event	5,000	36	35/60
Staff RN	57.500 Outpatient Dialysis Center Practices Survey	7,000	1	2.0
Registered Nurse (Infection Preventionist)	57.501 Dialysis Monthly Reporting Plan	7,000	12	5/60
Staff RN	57.502 Dialysis Event	7,000	60	25/60
Staff RN	57.503 Denominator for Outpatient Dialysis	7,000	12	10/60
Staff RN	57.504 Prevention Process Measures Monthly Monitoring for Dialysis	2,000	12	1.25
Staff RN	57.505 Dialysis Patient Influenza Vaccination	325	75	10/60
Staff RN	57.506 Dialysis Patient Influenza Vaccination Denominator	325	5	10/60
Staff RN	57.507 Home Dialysis Center Practices Survey	350	1	30/60

Leroy A. Richardson,

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.