Agency Forms Undergoing Paperwork Reduction Act Review
Citation | 84 FR 53441 |
Record Number | 2019-21753 |
Published date | 07 October 2019 |
Section | Notices |
Court | Centers For Disease Control And Prevention,Health And Human Services Department |
Federal Register, Volume 84 Issue 194 (Monday, October 7, 2019)
[Federal Register Volume 84, Number 194 (Monday, October 7, 2019)] [Notices] [Pages 53441-53444] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-21753] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-19-0666] 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 June 5, 2019 to obtain comments from the public and affected agencies. CDC received two comments 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 or send an email to [email protected]. 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)--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. During the early stages of its development, NHSN began as a voluntary surveillance system in 2005 managed by DHQP. 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 six components: Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN's new Neonatal Component is expected to launch during the summer of 2020. This component will focus on premature neonates and the healthcare- associated events that occur as a result of their prematurity. This component will be released with one module, which includes Late Onset- Sepsis and Meningitis. Late-onset sepsis (LOS) and Meningitis are common complications of extreme prematurity. Studies have indicated that 36% of extremely low gestational age (22-28 weeks) infants develop LOS and that 21% of very low birth weight infants surviving beyond three days of life will develop LOS. Meningitis occurs in 23% of bacteremic infants, but 38% of infants with a pathogen isolated from the cerebrospinal fluid may not have an organism isolated from blood. These infections are usually serious, causing a prolongation of hospital stay, increased cost, and risk of morbidity and mortality. Some cases of LOS can be prevented through proper central line insertion and maintenance practices. These are addressed in the CDC's Healthcare Infection Control Practices Advisory Committee (CDC/HICPAC) Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. However, almost one-third of LOS events in a quality- improvement study were not related to central-lines. [[Page 53442]] Prevention strategies for the non-central line-related infection events have yet to be fully defined, but include adherence to hand-hygiene, parent and visitor education, and optimum nursery design features. Other areas that likely influence the development of LOS include early enteral nutritional support and skin care practices. The data for this module will be electronically submitted, and manual data entry will not be available. This will allow more hospital personnel to be available to care for patients and will reduce annual burden across healthcare facilities. Additionally, LOS data will be utilized for prevention initiatives. Data reported under the Patient Safety Component are used to determine the magnitude of the healthcare-associated adverse events and trends in the rates of the events, in the distribution of pathogens, and in the adherence to prevention practices. Data will help detect changes in the epidemiology of adverse events resulting from new medical therapies and changing patient risks. Additionally, reported data is being used to describe the epidemiology of antimicrobial use and resistance and to better understand the relationship of antimicrobial therapy to this rising problem. Under the Healthcare Personnel Safety Component, protocols and 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 reported and analyzed to provide national estimates of adverse reactions and incidents. Under the Long-Term Care Facility Component, data is captured from skilled nursing facilities. Reporting methods under the LTCF component have been created by using forms from the PS Component as a model with modifications to specifically address the specific characteristics of LTCF residents and the unique data needs of these facilities reporting into NHSN. The Dialysis Component offers a simplified user interface for dialysis users to streamline their data entry and analyses processes as well as provide options for expanding in the future to include dialysis surveillance in settings other than outpatient facilities. The Outpatient Procedure Component (OPC) gathers data on the impact of infections and outcomes related to operative procedures performed in Ambulatory Surgery Centers (ASCs). The OPC is used to monitor two event types: Same Day Outcome Measures and Surgical Site Infections (SSIs). NHSN has increasingly served as the operating system for HAI reporting compliance through legislation established by the states. As of March 2019, 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 emphasis on those states and municipalities acquiring varying consequences for failure to use NHSN. Additionally, healthcare facilities in five U.S. territories (Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and the Northern Mariana Islands) are voluntarily reporting to NHSN. Additional territories are projected to follow with similar use of NHSN for reporting purposes. NHSN's 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. This project has resulted in a significant increase in long-term care facilities reporting to NHSN. The collection of information is authorized by the Public Health Service Act (42 U.S.C. 242b, 242k, and 242m (d)). The proposed changes in this new ICR include revisions made to 40 NHSN data collection tools for a total of 76 data collection tools included in this ICR. The reporting burden decreased by 2,363,508 hours for a total estimated burden of 3,033,930 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Respondent type Form No. & name respondents responses per response respondent (hours) ---------------------------------------------------------------------------------------------------------------- Healthcare Practitioner............ 57.100 NHSN Registration 2,000 1 5/60 Form. 57.101 Facility Contact 2,000 1 10/60 Information. 57.103 Patient Safety 5,175 1 75/60 Component--Annual Hospital Survey. 57.105 Group Contact 1,000 1 5/60 Information. 57.106 Patient Safety 6,000 12 15/60 Monthly Reporting Plan. 57.108 Primary Bloodstream 5,775 5 38/60 Infection (BSI). [[Page 53443]] 57.111 Pneumonia (PNEU).... 1,800 30 30/60 57.112 Ventilator- 5,500 5 28/60 Associated Event. 57.113 Pediatric Ventilator- 334 120 30/60 Associated Event (PedVAE). 57.114 Urinary Tract 5,500 5 20/60 Infection (UTI). 57.115 Custom Event........ 600 91 35/60 57.116 Denominators for 220 12 249/60 Neonatal Intensive Care Unit (NICU). 57.117 Denominators for 165 12 302/60 Specialty Care Area (SCA)/ Oncology (ONC). 57.118 Denominators for 5,500 60 302/60 Intensive Care Unit (ICU)/ Other locations (not NICU or SCA). 57.120 Surgical Site 4,500 11 35/60 Infection (SSI). 57.121 Denominator for 4,500 680 10/60 Procedure. 57.122 HAI Progress Report 55 1 45/60 State Health Department Survey. 57.123 Antimicrobial Use 1,500 12 5/60 and Resistance (AUR)- Microbiology Data Electronic Upload Specification Tables. 57.124 Antimicrobial Use 2,000 12 5/60 and Resistance (AUR)- Pharmacy Data Electronic Upload Specification Tables. 57.125 Central Line 500 213 25/60 Insertion Practices Adherence Monitoring. 57.126 MDRO or CDI 720 12 30/60 Infection Form. 57.127 MDRO and CDI 5,500 29 15/60 Prevention Process and Outcome Measures Monthly Monitoring. 57.128 Laboratory- 4,800 87 20/60 identified MDRO or CDI Event. 57.129 Adult Sepsis........ 50 250 25/60 57.137 Long-Term Care 2,220 1 120/60 Facility Component--Annual Facility Survey. 57.138 Laboratory- 2,150 24 15/60 identified MDRO or CDI Event for LTCF. 57.139 MDRO and CDI 2,200 12 20/60 Prevention Process Measures Monthly Monitoring for LTCF. 57.140 Urinary Tract 400 12 30/60 Infection (UTI) for LTCF. 57.141 Monthly Reporting 2,220 12 5/60 Plan for LTCF. 57.142 Denominators for 2,220 12 250/60 LTCF Locations. 57.143 Prevention Process 375 12 5/60 Measures Monthly Monitoring for LTCF. 57.150 LTAC Annual Survey.. 500 1 70/60 57.151 Rehab Annual Survey. 1,200 1 70/60 57.200 Healthcare Personnel 50 1 480/60 Safety Component Annual Facility Survey. 57.203 Healthcare Personnel .............. 1 5/60 Safety Monthly Reporting Plan. 57.204 Healthcare Worker 50 200 20/60 Demographic Data. 57.205 Exposure to Blood/ 50 50 60/60 Body Fluids. 57.206 Healthcare Worker 50 30 15/60 Prophylaxis/Treatment. 57.207 Follow-Up Laboratory 50 50 15/60 Testing. 57.210 Healthcare Worker 50 50 10/60 Prophylaxis/Treatment- Influenza. 57.300 Hemovigilance Module 500 1 85/60 Annual Survey. 57.301 Hemovigilance Module 500 12 1/60 Monthly Reporting Plan. 57.303 Hemovigilance Module 500 12 70/60 Monthly Reporting Denominators. 57.305 Hemovigilance 500 10 10/60 Incident. 57.306 Hemovigilance Module 500 1 35/60 Annual Survey--Non-acute care facility. 57.307 Hemovigilance 500 4 20/60 Adverse Reaction--Acute Hemolytic Transfusion Reaction. 57.308 Hemovigilance 500 4 20/60 Adverse Reaction--Allergic Transfusion Reaction. 57.30 Hemovigilance Adverse 500 1 20/60 Reaction--Delayed Hemolytic Transfusion Reaction. 57.310 Hemovigilance 500 2 20/60 Adverse Reaction--Delayed Serologic Transfusion Reaction. 57.311 Hemovigilance 500 4 20/60 Adverse Reaction--Febrile Non-hemolytic Transfusion Reaction. 57.312 Hemovigilance 500 1 20/60 Adverse Reaction-- Hypotensive Transfusion Reaction. 57.313 Hemovigilance 500 1 20/60 Adverse Reaction-- Infection. [[Page 53444]] 57.314 Hemovigilance 500 1 20/60 Adverse Reaction--Post Transfusion Purpura. 57.315 Hemovigilance 500 1 20/60 Adverse Reaction-- Transfusion Associated Dyspnea. 57.316 Hemovigilance 500 1 20/60 Adverse Reaction-- Transfusion Associated Graft vs. Host Disease. 57.317 Hemovigilance 500 1 20/60 Adverse Reaction-- Transfusion Related Acute Lung Injury. 57.318 Hemovigilance 500 2 20/60 Adverse Reaction-- Transfusion Associated Circulatory Overload. 57.319 Hemovigilance 500 1 20/60 Adverse Reaction--Unknown Transfusion Reaction. 57.320 Hemovigilance 500 1 20/60 Adverse Reaction--Other Transfusion Reaction. 57.400 Outpatient Procedure 700 1 10/60 Component--Annual Facility Survey. 57.401 Outpatient Procedure 700 12 15/60 Component--Monthly Reporting Plan. 57.402 Outpatient Procedure 200 1 40/60 Component Same Day Outcome Measures. 57.403 Outpatient Procedure 200 400 40/60 Component--Monthly Denominators for Same Day Outcome Measures. 57.404 Outpatient Procedure 700 100 40/60 Component--SSI Denominator. 57.405 Outpatient Procedure 700 5 40/60 Component--Surgical Site (SSI) Event. 57.500 Outpatient Dialysis 7,100 1 127/60 Center Practices Survey. 57.501 Dialysis Monthly 7,100 12 5/60 Reporting Plan. 57.502 Dialysis Event...... 7,100 30 25/60 57.503 Denominator for 7,100 12 10/60 Outpatient Dialysis. 57.504 Prevention Process 1,760 12 75/60 Measures Monthly Monitoring for Dialysis. 57.505 Dialysis Patient 860 60 10/60 Influenza Vaccination. 57.506 Dialysis Patient 860 1 5/60 Influenza Vaccination Denominator. 57.507 Home Dialysis Center 430 1 30/60 Practices Survey. ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention. [FR Doc. 2019-21753 Filed 10-4-19; 8:45 am] BILLING CODE 4163-18-P