88 FR 78 pgs. 24802-24805 - Agency Forms Undergoing Paperwork Reduction Act Review
Type: NOTICEVolume: 88Number: 78Pages: 24802 - 24805
Pages: 24802, 24803, 24804, 24805Docket number: [30Day-23-0666]
FR document: [FR Doc. 2023-08571 Filed 4-21-23; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Centers for Disease Control and Prevention
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-23-0666]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled "National Healthcare Safety Network (NHSN)" to the Office of Management and Budget (OMB) for review and approval. CDC previously published a "Proposed Data Collection Submitted for Public Comment and Recommendations" notice on August 26, 2022 to obtain comments from the public and affected agencies. CDC received one comment related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. 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 (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting "Currently under 30-day Review-Open for Public Comments" or by using the search function. 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 (202) 395-5806. Provide written comments within 30 days of notice publication.
Proposed Project
National Healthcare Safety Network (NHSN) (OMB Control No. 0920-0666, Exp. 7/31/2023)-Revision-National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control Number 0920-0666. NHSN provides facilities, states, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare-associated infections (HAIs) nationwide. NHSN allows healthcare facilities to track blood safety errors and various healthcare-associated infection prevention practice methods such as healthcare personnel influenza vaccine status and corresponding infection control adherence rates. NHSN currently has seven components:
[top] Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), Dialysis Component, and the Neonatal Component. NHSN has increasingly served as the operating system for HAI reporting compliance through legislation established by the states. As of April 2020, 36 states, the District of Columbia and the City of Philadelphia, Pennsylvania have opted to use NHSN as their primary system for mandated reporting. Reporting compliance is completed by healthcare facilities in their respective jurisdictions, with
NHSN data is used to aid in the tracking of HAIs and guide infection prevention activities/practices that protect patients. The Centers for Medicare and Medicaid Services (CMS) and other payers use these data to determine incentives for performance at healthcare facilities across the US and surrounding territories, and members of the public may use some protected data to inform their selection among available providers. Each of these parties is dependent on the completeness and accuracy of the data. CDC and CMS work closely and are fully committed to ensuring complete and accurate reporting, which are critical for protecting patients and guiding national, state, and local prevention priorities. CMS collects some HAI data and healthcare personnel influenza vaccination summary data, which is done on a voluntary basis as part of its Fee-for-Service Medicare quality reporting programs, while others may report data required by a federal mandate. Facilities that fail to report quality measure data are subject to partial payment reduction in the applicable Medicare Fee-for-Service payment system. CMS links their quality reporting to payment for Medicare-eligible acute care hospitals, inpatient rehabilitation facilities, long-term acute care facilities, oncology hospitals, inpatient psychiatric facilities, dialysis facilities, and ambulatory surgery centers. Facilities report HAI data and healthcare personnel influenza vaccination summary data to CMS via NHSN as part of CMS's quality reporting programs to receive full payment. Still, many healthcare facilities, even in states without HAI reporting legislation, submit limited HAI data to NHSN voluntarily.
NHSN's data collection updates continue to support the incentive programs managed by CMS. For example, survey questions support requirements for CMS' quality reporting programs. Additionally, CDC has collaborated with CMS on a voluntary National Nursing Home Quality Collaborative, which focuses on recruiting nursing homes to report HAI data to NHSN and to retain their continued participation.
In January 2023, CDC obtained emergency OMB approval for a number of changes, effective immediately (Exp. 7/31/2023). These changes included the addition of a new Monthly Survey on Patient Days & Nurse Staffing, as well as minor changes to 14 information collection forms. The changes primarily supported clarifications to use of CIDTs, HAI forms with susceptibility reporting requirements, vendor information, testing options for UTI events, and all y-types of hepatitis B vaccines administered to patients and staff members at outpatient dialysis centers. The changes increased total annualized burden for NHSB from 1,584,651 hours to 1,616,151 hours.
In this Revision, CDC requests OMB approval to continue those changes for three years. In addition, CDC requests OMB approval to begin phased implementation of two new questions on Sex at Birth and Gender Identity, which will replace the current Gender question. The new questions will be voluntary for the remainder of 2023 and required in 2024. The proposed change will be used to help assess the true impact of sex at birth and gender identify on HAIs, individually and in combination with other risk factors, and to inform public health programs. The new questions will add one minute of burden to 31 forms that are currently in use, a total of 77,064 annualized burden hours. The total estimated annualized burden hours for NHSN will increase to 1,693,215 hours.
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| Form number/name | Number of respondents | Number of responses per respondent | Average burden per response (min/hour) |
|---|---|---|---|
| 57.100 NHSN Registration Form | 2,000 | 1 | 5/60 |
| 57.101 Facility Contact Information | 2,000 | 1 | 10/60 |
| 57.103 Patient Safety Component-Annual Hospital Survey | 6,765 | 1 | 90/60 |
| 57.104 Facility Administrator Change Request Form | 800 | 1 | 5/60 |
| 57.105 Group Contact Information | 1,000 | 1 | 5/60 |
| 57.106 Patient Safety Monthly Reporting Plan | 7,821 | 12 | 15/60 |
| 57.108 Primary Bloodstream Infection (BSI) | 5,775 | 5 | 39/60 |
| 57.111 Pneumonia (PNEU) | 1,800 | 2 | 31/60 |
| 57.112 Ventilator-Associated Event | 5,463 | 8 | 29/60 |
| 57.113 Pediatric Ventilator-Associated Event (PedVAE) | 334 | 1 | 31/60 |
| 57.114 Urinary Tract Infection (UTI) | 6,000 | 5 | 21/60 |
| 57.115 Custom Event | 600 | 91 | 36/60 |
| 57.116 Denominators for Neonatal Intensive Care Unit (NICU) | 1,100 | 12 | 4/60 |
| 57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC) | 500 | 12 | 5/60 |
| 57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA) | 5,500 | 60 | 5/60 |
| 57.120 Surgical Site Infection (SSI) | 6,000 | 9 | 36/60 |
| 57.121 Denominator for Procedure | 6,000 | 602 | 11/60 |
| 57.122 HAI Progress Report State Health Department Survey | 55 | 1 | 28/60 |
| 57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables | 2,500 | 12 | 5/60 |
| 57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables | 4,000 | 12 | 5/60 |
| 57.125 Central Line Insertion Practices Adherence Monitoring | 500 | 213 | 26/60 |
| 57.126 MDRO or CDI Infection Form | 720 | 11 | 31/60 |
| 57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring | 5,500 | 29 | 15/60 |
| 57.128 Laboratory-identified MDRO or CDI Event | 4,800 | 79 | 21/60 |
| 57.129 Adult Sepsis | 50 | 250 | 25/60 |
| 57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table for monthly electronic upload | 300 | 6 | 5/60 |
| 57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly Electronic Upload | 300 | 6 | 5/60 |
| 57.137 Long-Term Care Facility Component-Annual Facility Survey | 17,700 | 1 | 120/60 |
| 57.138 Laboratory-identified MDRO or CDI Event for LTCF | 1,998 | 24 | 20/60 |
| 57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF | 1,998 | 12 | 20/60 |
| 57.140 Urinary Tract Infection (UTI) for LTCF | 339 | 36 | 35/60 |
| 57.141 Monthly Reporting Plan for LTCF | 2,011 | 12 | 5/60 |
| 57.142 Denominators for LTCF Locations | 339 | 12 | 35/60 |
| 57.143 Prevention Process Measures Monthly Monitoring for LTCF | 130 | 12 | 5/60 |
| 57.150 LTAC Annual Survey | 620 | 1 | 82/60 |
| 57.151 Rehab Annual Survey | 1,340 | 1 | 82/60 |
| 57.200 Healthcare Personnel Safety Component Annual Facility Survey | 50 | 1 | 480/60 |
| 57.204 Healthcare Worker Demographic Data | 50 | 200 | 20/60 |
| 57.205 Exposure to Blood/Body Fluids | 50 | 50 | 60/60 |
| 57.206 Healthcare Worker Prophylaxis/Treatment | 50 | 30 | 15/60 |
| 57.207 Follow-Up Laboratory Testing | 50 | 50 | 15/60 |
| 57.210 Healthcare Worker Prophylaxis/Treatment-Influenza | 50 | 50 | 10/60 |
| 57.300 Hemovigilance Module Annual Survey | 500 | 1 | 86/60 |
| 57.301 Hemovigilance Module Monthly Reporting Plan | 500 | 12 | 60/60 |
| 57.303 Hemovigilance Module Monthly Reporting Denominators | 500 | 12 | 70/60 |
| 57.305 Hemovigilance Incident | 500 | 10 | 10/60 |
| 57.306 Hemovigilance Module Annual Survey-Non-acute care facility | 500 | 1 | 36/60 |
| 57.307 Hemovigilance Adverse Reaction-Acute Hemolytic Transfusion Reaction | 500 | 4 | 21/60 |
| 57.308 Hemovigilance Adverse Reaction-Allergic Transfusion Reaction | 500 | 4 | 21/60 |
| 57.309 Hemovigilance Adverse Reaction-Delayed Hemolytic Transfusion Reaction | 500 | 1 | 21/60 |
| 57.310 Hemovigilance Adverse Reaction-Delayed Serologic Transfusion Reaction | 500 | 2 | 21/60 |
| 57.311 Hemovigilance Adverse Reaction-Febrile Non-hemolytic Transfusion Reaction | 500 | 4 | 21/60 |
| 57.312 Hemovigilance Adverse Reaction-Hypotensive Transfusion Reaction | 500 | 1 | 21/60 |
| 57.313 Hemovigilance Adverse Reaction-Infection | 500 | 1 | 21/60 |
| 57.314 Hemovigilance Adverse Reaction-Post Transfusion Purpura | 500 | 1 | 21/60 |
| 57.315 Hemovigilance Adverse Reaction-Transfusion Associated Dyspnea | 500 | 1 | 20/60 |
| 57.316 Hemovigilance Adverse Reaction-Transfusion Associated Graft vs. Host Disease | 500 | 1 | 21/60 |
| 57.317 Hemovigilance Adverse Reaction-Transfusion Related Acute Lung Injury | 500 | 1 | 21/60 |
| 57.318 Hemovigilance Adverse Reaction-Transfusion Associated Circulatory Overload | 500 | 2 | 21/60 |
| 57.319 Hemovigilance Adverse Reaction-Unknown Transfusion Reaction | 500 | 1 | 21/60 |
| 57.320 Hemovigilance Adverse Reaction-Other Transfusion Reaction | 500 | 1 | 21/60 |
| 57.400 Outpatient Procedure Component-Annual Facility Survey | 700 | 1 | 10/60 |
| 57.401 Outpatient Procedure Component-Monthly Reporting Plan | 700 | 12 | 15/60 |
| 57.402 Outpatient Procedure Component Same Day Outcome Measures | 200 | 1 | 41/60 |
| 57.403 Outpatient Procedure Component-Monthly Denominators for Same Day Outcome Measures | 200 | 400 | 40/60 |
| 57.404 Outpatient Procedure Component-SSI Denominator | 700 | 100 | 41/60 |
| 57.405 Outpatient Procedure Component-Surgical Site (SSI) Event | 700 | 5 | 41/60 |
| 57.500 Outpatient Dialysis Center Practices Survey | 7,200 | 1 | 12/60 |
| 57.501 Dialysis Monthly Reporting Plan | 7,200 | 12 | 5/60 |
| 57.502 Dialysis Event | 7,200 | 30 | 26/60 |
| 57.503 Denominator for Outpatient Dialysis | 7,200 | 30 | 10/60 |
| 57.504 Prevention Process Measures Monthly Monitoring for Dialysis | 1,730 | 12 | 75/60 |
| 57.505 Dialysis Patient Influenza Vaccination | 615 | 50 | 10/60 |
| 57.506 Dialysis Patient Influenza Vaccination Denominator | 615 | 5 | 10/60 |
| 57.507 Home Dialysis Center Practices Survey | 430 | 1 | 30/60 |
| Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Non-Long-Term Care Facilities | 125 | 52 | 60/60 |
| Weekly Healthcare Personnel Influenza Vaccination Cumulative Summary for Long-Term Care Facilities | 1,200 | 52 | 60/60 |
| Weekly Resident Influenza Vaccination Cumulative Summary for Long-Term Care Facilities | 2,500 | 52 | 60/60 |
| Annual Healthcare Personnel Influenza Vaccination Summary | 5,000 | 1 | 120/60 |
| Monthly Survey Patient Days & Nurse Staffing | 2,500 | 12 | 60/60 |
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Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.
[FR Doc. 2023-08571 Filed 4-21-23; 8:45 am]
BILLING CODE 4163-18-P