| Page Range | 46490-46493 | |
| FR Document | 2018-19902 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Notices] [Pages 46490-46493] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19902] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-0666] 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 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 May 11, 2018 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 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 (0920-0666, Expiration Date 1/ 31/2021)--Revision--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship. Specifically, resulting data estimates the magnitude of Healthcare Associated Infections (HAI), monitor HAI trends, and facilitate inter-facility and intra-facility comparisons with risk-adjusted data used for local quality improvement activities. 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 six components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility (LTCF), Outpatient Procedure Component, and Dialysis. Changes were made to 34 data collection facility surveys with this revision ICR. CDC revised three annual facility surveys for the Patient Safety component for Hospitals, Long-Term Acute Care Facilities, and Inpatient Rehabilitation Facilities. CDC's revisions clarify the reporting requirements for the data collected on fungal testing, facility locations, and laboratory testing locations. Additionally, corresponding response [[Page 46491]] options for these questions have been revised to include updated testing methods used by facilities to capture current HAI specific data specification requirements for NHSN. New required questions have been added to all Patient Safety component surveys. The new questions are designed to provide data on surveillance processes, policies, and standards that are used by reporting facilities to ensure that when an event is detected, the facility has the appropriate mechanism to conduct complete reporting. The Hospital Annual Survey added new required questions to provide data about neonatal antimicrobial stewardship practices because the focus of stewardship efforts in neonatology differ from the focus in adult and pediatric practice. Questions were removed and replaced on all three Patient Safety surveys to align better with the Core Elements of Hospital Antibiotic Stewardship Programs specified by CDC. The Core Elements defined by CDC are part of broad-based efforts by CDC and its healthcare and public health partners to combat the threat of antibiotic-resistant bacteria. The new Antibiotic Stewardship Program questions will provide additional data about operational features of the programs that hospitals have implemented, which in turn will enable CDC and its healthcare and public health partners to target their efforts to help invigorate and extend antibiotic stewardship. CDC is introducing a new optional survey form that is designed to be completed by state and local health departments that participate in HAI surveillance and prevention activities. This new form will provide data on legal and regulatory requirements that are pertinent to HAI reporting. CDC plans to include data the health department survey in its annual National and State Healthcare-Associated Infection Progress Report. The report helps identify the progress in HAI surveillance and prevention at the state and national levels. Data about the extent to which state health departments have validated HAI data that healthcare facilities in their jurisdiction report to NHSN and the extent of state and local health department HAI reporting requirements are important data for users of CDC's HAI Progress Report to consider when they are reviewing and interpreting data in the report. NHSN now includes a ventilator-associated event available for NICU locations, which requires additional denominator reporting, in which CDC has provided an option to accommodate facilities that are reporting requested data by updating the corresponding surveys. The Pediatric Ventilator-Associated Event (PedVAE) was removed from the survey because a single algorithm is used to detect PedVAE events. NHSN has made updates to the Antimicrobial Use and Resistance (AUR) data collection tools for the purposes of monitoring additional microorganisms and their antimicrobial susceptibility profiles. Use of these updates in AUR surveillance will provide important additional data for clinical and public health responses to mounting antibiotic resistance problems. The Long-term Care Facility Component (LTCF) will be updating three forms, two of which will include an update for facilities to document the ``CDI treatment start'' variable. Early CDI reporting data from nursing homes has shown exceptionally low event rates for many reporting facilities (e.g., zero events for six or more months). Since current CDI event detection is based on presence of a positive laboratory specimen, variability in the use of diagnostic testing as part of CDI management will have direct impact on the estimate of CDI burden in a facility (e.g., empiric treatment for CDI without confirmatory testing may result in the appearance of low disease burden). In order to determine whether low CDI event rates might be due to empiric CDI treatment practices, a new process measure will be incorporated into the monthly summary data on CDI for LTCFs. This measure, called ``CDI treatment starts,'' will allow providers to capture the number of residents started on antibiotic treatment for CDI that month based on clinical decisions (i.e., even those without a positive CDI test). This process measure should provide data on clinically-treated CDI in order to inform our understanding of CDI management practices and serve as a proxy for CDI burden in nursing homes. Overall, minor revisions have been made to a total of 34 forms within the package to clarify and/or update surveillance definitions, increase or decrease the number of reporting facilities, and add new forms. Finally, NHSN has achieved significant burden reduction with this ICR due to a decrease in the number of respondents for the Specialty Care Area (SCA) and Oncology (ONC) facilities reporting to NHSN. NHSN re-evaluated these reporting facilities and determined that approximately 2,000 SCA and ONC facilities are reporting to NHSN compared to the estimated 6,000 that was estimated last year. Additionally, NHSN streamlined many response options, which also attributed to a reduction in the overall burden. The previously approved NHSN package included 72 individual collection forms; the current revision request includes a total of 73 forms. The reporting burden will decrease by 109,745 hours, for a total of 5,393,725 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Healthcare facility................ 57.100 NHSN Registration 2,000 1 5/60 Form. 57.101 Facility Contact 2,000 1 10/60 Information. 57.103 Patient Safety 6,000 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 6,000 44 33/60 Infection (BSI). 57.111 Pneumonia (PNEU).... 1,800 72 30/60 57.112 Ventilator- 6,000 144 28/60 Associated Event. 57.113 Pediatric Ventilator- 100 120 30/60 Associated Event (PedVAE). 57.114 Urinary Tract 6,000 40 20/60 Infection (UTI). 57.115 Custom Event........ 600 91 35/60 57.116 Denominators for 6,000 12 4 Neonatal Intensive Care Unit (NICU). [[Page 46492]] 57.117 Denominators for 2,000 9 302/60 Specialty Care Area (SCA)/ Oncology (ONC). 57.118 Denominators for 6,000 60 302/60 Intensive Care Unit (ICU)/ Other locations (not NICU or SCA). 57.120 Surgical Site 6,000 36 35/60 Infection (SSI). 57.121 Denominator for 6,000 540 10/60 Procedure. 57.122 HAI Progress Report 55 1 45/60 State Health Department Survey. 57.123 Antimicrobial Use 1,000 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 100 100 25/60 Insertion Practices Adherence Monitoring. 57.126 MDRO or CDI 6,000 72 30/60 Infection Form. 57.127 MDRO and CDI 6,000 24 15/60 Prevention Process and Outcome Measures Monthly Monitoring. 57.128 Laboratory- 6,000 240 20/60 identified MDRO or CDI Event. 57.129 Adult Sepsis........ 50 250 25/60 57.137 Long-Term Care 2,600 1 2 Facility Component--Annual Facility Survey. 57.138 Laboratory- 2,600 12 20/60 identified MDRO or CDI Event for LTCF. 57.139 MDRO and CDI 2,600 12 20/60 Prevention Process Measures Monthly Monitoring for LTCF. 57.140 Urinary Tract 2,600 14 35/60 Infection (UTI) for LTCF. 57.141 Monthly Reporting 2,600 12 5/60 Plan for LTCF. 57.142 Denominators for 2,600 12 250/60 LTCF Locations. 57.143 Prevention Process 2,600 12 5/60 Measures Monthly Monitoring for LTCF. 57.150 LTAC Annual Survey.. 400 1 70/60 57.151 Rehab Annual Survey. 1,000 1 70/60 57.200 Healthcare Personnel 50 1 8 Safety Component Annual Facility Survey. 57.203 Healthcare Personnel 19,500 1 5/60 Safety Monthly Reporting Plan. 57.204 Healthcare Worker 50 200 20/60 Demographic Data. 57.205 Exposure to Blood/ 50 50 1 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 200 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. 57.309 Hemovigilance 500 1 20/60 Adverse 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. 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. [[Page 46493]] 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 5,000 1 10/60 Component--Annual Facility Survey. 57.401 Outpatient Procedure 5,000 12 20/60 Component--Monthly Reporting Plan. 57.402 Outpatient Procedure 1,200 25 40/60 Component Same Day Outcome Measures. 57.403 Outpatient Procedure 1,200 12 40/60 Component--Monthly Denominators for Same Day Outcome Measures. 57.404 Outpatient Procedure 5,000 540 10/60 Component--SSI Denominator. 57.405 Outpatient Procedure 5,000 36 35/60 Component--Surgical Site (SSI) Event. 57.500 Outpatient Dialysis 7,000 1 127/60 Center Practices Survey. 57.501 Dialysis Monthly 7,000 12 5/60 Reporting Plan. 57.502 Dialysis Event...... 7,000 60 25/60 57.503 Denominator for 7,000 12 10/60 Outpatient Dialysis. 57.504 Prevention Process 2,000 12 85/60 Measures Monthly Monitoring for Dialysis. 57.505 Dialysis Patient 325 75 10/60 Influenza Vaccination. 57.506 Dialysis Patient 325 5 10/60 Influenza Vaccination Denominator. 57.507 Home Dialysis Center 350 1 30/60 Practices Survey. ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting 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. [FR Doc. 2018-19902 Filed 9-12-18; 8:45 am] BILLING CODE 4163-18-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 46490 |