82_FR_24813
Page Range | 24711-24714 | |
FR Document | 2017-11020 |
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)] [Notices] [Pages 24711-24714] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-11020] [[Page 24711]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-0666; Docket No. CDC-2017-0047] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Healthcare Safety Network (NHSN). 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. DATES: Written comments must be received on or before July 31, 2017. ADDRESSES: You may submit comments, identified by Docket No. CDC-2017- 0047 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov. Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. 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; (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; and (e) estimates of capital or start- up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. Proposed Project National Healthcare Safety Network (NHSN) (OMB Control Number 0920- 0666, Expires--Revision--National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) Background and Brief Description The Centers for Disease Control and Prevention (CDC) is requesting a three-year approval of the National Healthcare Safety Network information collection project. 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 collected will be used to inform and 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. The Outpatient Procedure Component is on track to be released in NHSN in 2018. The development of this component has been previously delayed to obtain additional user feedback and support from outside partners. Changes were made to four facility surveys. Based on user feedback and internal reviews of the annual facility surveys it was determined that questions and response options be amended, removed, or added to fit the evolving uses of the annual facility surveys. Also, the surveys are being increasingly used 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. An additional 14 forms were modified within the Hemovigilance module to streamline data collection/entry for adverse reaction events. [[Page 24712]] Overall, minor revisions have been made to a total of 38 forms within the package to clarify and/or update surveillance definitions, increase or decrease the number of reporting facilities, and adding new forms. The previously approved NHSN package included 70 individual collection forms; the current revision request includes a total of 72 forms. The reporting burden will decrease by 811,985 hours, for a total of 5,922,953 hours. This collection of information is authorized by the Public Health Service Act (42 U.S.C. 242b, 242k, and 242m (d)). There is no cost to respondents other than the time to participate. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form No. & name Number of responses per per response Total burden respondents respondent (hours) (hours) ---------------------------------------------------------------------------------------------------------------- Registered Nurse (Infection 57.100 NHSN 2,000 1 5/60 167 Preventionist). Registration Form. Registered Nurse (Infection 57.101 Facility 2,000 1 10/60 333 Preventionist). Contact Information. Registered Nurse (Infection 57.103 Patient 5,000 1 55/60 4,583 Preventionist). Safety Component--Annu al Hospital Survey. Registered Nurse (Infection 57.105 Group 1,000 1 5/60 83 Preventionist). Contact Information. Registered Nurse (Infection 57.106 Patient 6,000 12 15/60 18,000 Preventionist). Safety Monthly Reporting Plan. Registered Nurse (Infection 57.108 Primary 6,000 44 30/60 132,000 Preventionist). Bloodstream Infection (BSI). Registered Nurse (Infection 57.111 Pneumonia 6,000 72 30/60 216,000 Preventionist). (PNEU). Registered Nurse (Infection 57.112 6,000 144 25/60 360,000 Preventionist). Ventilator--Ass ociated Event. Registered Nurse (Infection 57.113 Pediatric 2,000 120 25/60 100,000 Preventionist). Ventilator--Ass ociated Event (PedVAE). Registered Nurse (Infection 57.114 Urinary 6,000 40 20/60 80,000 Preventionist). Tract Infection (UTI). Registered Nurse (Infection 57.115 Custom 2,000 91 35/60 106,167 Preventionist). Event. Staff RN...................... 57.116 6,000 12 4 288,000 Denominators for Neonatal Intensive Care Unit (NICU). Staff RN...................... 57.117 6,000 9 5 270,000 Denominators for Specialty Care Area (SCA)/ Oncology (ONC). Staff RN...................... 57.118 6,000 60 5 1,800,000 Denominators for Intensive Care Unit (ICU)/ Other locations (not NICU or SCA). Registered Nurse (Infection 57.120 Surgical 6,000 36 35/60 126,000 Preventionist). Site Infection (SSI). Staff RN...................... 57.121 6,000 540 10/60 540,000 Denominator for Procedure. Laboratory Technician......... 57.123 6,000 12 5/60 6,000 Antimicrobial Use and Resistance (AUR)--Microbio logy Data Electronic Upload Specification Tables. Pharmacist.................... 57.124 6,000 12 5/60 6,000 Antimicrobial Use and Resistance (AUR)--Pharmacy Data Electronic Upload Specification Tables. Registered Nurse (Infection 57.125 Central 100 100 25/60 4,167 Preventionist). Line Insertion Practices Adherence Monitoring. Registered Nurse (Infection 57.126 MDRO or 6,000 72 30/60 216,000 Preventionist). CDI Infection Form. Registered Nurse (Infection 57.127 MDRO and 6,000 24 15/60 36,000 Preventionist). CDI Prevention Process and Outcome Measures Monthly Monitoring. Registered Nurse (Infection 57.128 6,000 240 20/60 480,000 Preventionist). Laboratory- identified MDRO or CDI Event. Registered Nurse (Infection 57.129 Adult 50 250 25/60 5,208 Preventionist). Sepsis. Registered Nurse (Infection 57.137 Long-Term 2,600 1 2 5,200 Preventionist). Care Facility Component--Annu al Facility Survey. Registered Nurse (Infection 57.138 2,600 12 15/60 7,800 Preventionist). Laboratory- identified MDRO or CDI Event for LTCF. Registered Nurse (Infection 57.139 MDRO and 2,600 12 10/60 5,200 Preventionist). CDI Prevention Process Measures Monthly Monitoring for LTCF. Registered Nurse (Infection 57.140 Urinary 2,600 14 30/60 18,200 Preventionist). Tract Infection (UTI) for LTCF. [[Page 24713]] Registered Nurse (Infection 57.141 Monthly 2,600 12 5/60 2,600 Preventionist). Reporting Plan for LTCF. Registered Nurse (Infection 57.142 2,600 12 4 124,800 Preventionist). Denominators for LTCF Locations. Registered Nurse (Infection 57.143 2,600 12 5/60 600 Preventionist). Prevention Process Measures Monthly Monitoring for LTCF. Registered Nurse (Infection 57.150 LTAC 400 1 55/60 367 Preventionist). Annual Survey. Registered Nurse (Infection 57.151 Rehab 1,000 1 55/60 917 Preventionist). Annual Survey. Occupational Health RN/ 57.200 50 1 8 400 Specialist. Healthcare Personnel Safety Component Annual Facility Survey. Occupational Health RN/ 57.203 17,000 1 5/60 1,417 Specialist. Healthcare Personnel Safety Monthly Reporting Plan. Occupational Health RN/ 57.204 50 200 20/60 3,333 Specialist. Healthcare Worker Demographic Data. Occupational Health RN/ 57.205 Exposure 50 50 1 2,500 Specialist. to Blood/Body Fluids. Occupational Health RN/ 57.206 50 30 15/60 375 Specialist. Healthcare Worker Prophylaxis/ Treatment. Laboratory Technician......... 57.207 Follow-Up 50 50 15/60 625 Laboratory Testing. Occupational Health RN/ 57.210 50 50 10/60 417 Specialist. Healthcare Worker Prophylaxis/ Treatment--Infl uenza. Medical/Clinical Laboratory 57.300 500 1 2 1,000 Technologist. Hemovigilance Module Annual Survey. Medical/Clinical Laboratory 57.301 500 12 1/60 100 Technologist. Hemovigilance Module Monthly Reporting Plan. Medical/Clinical Laboratory 57.303 500 12 1.17 7,020 Technologist. Hemovigilance Module Monthly Reporting Denominators. Medical/Clinical Laboratory 57.305 500 10 10/60 833 Technologist. Hemovigilance Incident. Medical/Clinical Laboratory 57.306 200 1 35/60 117 Technologist. Hemovigilance Module Annual Survey--Non- acute care facility. Medical/Clinical Laboratory 57.307 500 4 20/60 667 Technologist. Hemovigilance Adverse Reaction--Acute Hemolytic Transfusion Reaction. Medical/Clinical Laboratory 57.308 500 4 20/60 667 Technologist. Hemovigilance Adverse Reaction--Aller gic Transfusion Reaction. Medical/Clinical Laboratory 57.309 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Delay ed Hemolytic Transfusion Reaction. Medical/Clinical Laboratory 57.310 500 2 20/60 333 Technologist. Hemovigilance Adverse Reaction--Delay ed Serologic Transfusion Reaction. Medical/Clinical Laboratory 57.311 500 4 20/60 667 Technologist. Hemovigilance Adverse Reaction--Febri le Non- hemolytic Transfusion Reaction. Medical/Clinical Laboratory 57.312 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Hypot ensive Transfusion Reaction. Medical/Clinical Laboratory 57.313 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Infec tion. Medical/Clinical Laboratory 57.314 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Post Transfusion Purpura. Medical/Clinical Laboratory 57.315 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Trans fusion Associated Dyspnea. Medical/Clinical Laboratory 57.316 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Trans fusion Associated Graft vs. Host Disease. Medical/Clinical Laboratory 57.317 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Trans fusion Related Acute Lung Injury. [[Page 24714]] Medical/Clinical Laboratory 57.318 500 2 20/60 333 Technologist. Hemovigilance Adverse Reaction--Trans fusion Associated Circulatory Overload. Medical/Clinical Laboratory 57.319 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Unkno wn Transfusion Reaction. Medical/Clinical Laboratory 57.320 500 1 20/60 167 Technologist. Hemovigilance Adverse Reaction--Other Transfusion Reaction. Medical/Clinical Laboratory 57.400 5,000 1 5/60 417 Technologist. Outpatient Procedure Component--Annu al Facility Survey. Staff RN...................... 57.401 5,000 12 15/60 15,000 Outpatient Procedure Component--Mont hly Reporting Plan. Staff RN...................... 57.402--Outpatie 5,000 25 40/60 83,333 nt Procedure Component Same Day Outcome Measures & Prophylactic Intravenous(IV) Antibiotic Timing Event. Staff RN...................... 57.403--Outpatie 5,000 12 40/60 40,000 nt Procedure Component--Mont hly Denominators for Same Day Outcome Measures & Prophylactic Intravenous(IV) Antibiotic Timing Event. Staff RN...................... 57.404 5,000 540 10/60 450,00 Outpatient Procedure Component--Annu al Facility Survey. Registered Nurse (Infection 57.405 5,000 36 35/60 105,00 Preventionist). Outpatient Procedure Component--Surg ical Site (SSI) Event. Staff RN...................... 57.500 7,000 1 2.0 14,000 Outpatient Dialysis Center Practices Survey. Registered Nurse (Infection 57.501 Dialysis 7,000 12 5/60 7,000 Preventionist). Monthly Reporting Plan. Staff RN...................... 57.502 Dialysis 7,000 60 25/60 175,000 Event. Staff RN...................... 57.503 7,000 12 10/60 14,000 Denominator for Outpatient Dialysis. Staff RN...................... 57.504 2,000 12 1.25 30,000 Prevention Process Measures Monthly Monitoring for Dialysis. Staff RN...................... 57.505 Dialysis 325 75 10/60 4,063 Patient Influenza Vaccination. Staff RN...................... 57.506 Dialysis 325 5 10/60 271 Patient Influenza Vaccination Denominator. Staff RN...................... 57.507 Home 350 1 30/60 175 Dialysis Center Practices Survey. --------------------------------------------------------------- Total..................... ................ .............. .............. .............. 5922,953 ---------------------------------------------------------------------------------------------------------------- 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. [FR Doc. 2017-11020 Filed 5-26-17; 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 | |
Action | Notice with comment period. | |
Dates | Written comments must be received on or before July 31, 2017. | |
Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
FR Citation | 82 FR 24711 |