[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34337-34341]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12701]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-0666; Docket No. CDC-2016-0046]
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.
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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 August 1, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0046 by any of the following methods:
Federal eRulemaking Portal: Regulation.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 the Information
[[Page 34338]]
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)--Revision--National
Center for Emerging and Zoonotic Infection 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, 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 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 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 2017/2018. The development of this component has
been previously delayed to obtain additional user feedback and support
from outside partners.
Changes were made to six facility surveys and two new facility
surveys were added. 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. 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, three new forms were added to expand NHSN surveillance to
pediatric ventilator-associated events, adult sepsis, and custom HAI
event surveillance. An additional 14 forms were added to the
Hemovigilance Component to streamline data collection/entry for adverse
reaction events.
Additionally, minor revisions have been made to 22 forms within the
package to clarify and/or update surveillance definitions. The
previously approved NHSN package included 52 individual collection
forms; the current revision request adds nineteen forms and removes one
form for a total of 70 forms. The reporting burden will increase by
489,174 hours, for a total of 5,110,716 hours.
Estimated Annualized Burden Hours
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Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents Respondent (in hrs.) (in hrs.)
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Registered Nurse (Infection Preventionist)..... 57.100 NHSN Registration Form.......... 2,000 1 5/60 167
Registered Nurse (Infection Preventionist)..... 57.101 Facility Contact Information.... 2,000 1 10/60 333
Registered Nurse (Infection Preventionist)..... 57.103 Patient Safety Component--Annual 5,000 1 55/60 4,583
Hospital Survey.
Registered Nurse (Infection Preventionist)..... 57.105 Group Contact Information....... 1,000 1 5/60 83
Registered Nurse (Infection Preventionist)..... 57.106 Patient Safety Monthly Reporting 6,000 12 15/60 18,000
Plan.
Registered Nurse (Infection Preventionist)..... 57.108 Primary Bloodstream Infection 6,000 44 30/60 132,000
(BSI).
Registered Nurse (Infection Preventionist)..... 57.111 Pneumonia (PNEU)................ 6,000 72 30/60 216,000
Registered Nurse (Infection Preventionist)..... 57.112 Ventilator-Associated Event..... 6,000 144 25/60 360,000
Registered Nurse (Infection Preventionist)..... 57.113 Pediatric Ventilator-Associated 2,000 120 25/60 100,000
Event (PedVAE).
[[Page 34339]]
Registered Nurse (Infection Preventionist)..... 57.114 Urinary Tract Infection (UTI)... 6,000 40 20/60 80,000
Registered Nurse (Infection Preventionist)..... 57.115 Custom Event.................... 2,000 91 35/60 106,167
Staff RN....................................... 57.116 Denominators for Neonatal 6,000 9 3 162,000
Intensive Care Unit (NICU).
Staff RN....................................... 57.117 Denominators for Specialty Care 6,000 9 5 270,000
Area (SCA)/Oncology (ONC).
Staff RN....................................... 57.118 Denominators for Intensive Care 6,000 60 5 1,800,000
Unit (ICU)/Other locations (not NICU
or SCA).
Registered Nurse (Infection Preventionist)..... 57.120 Surgical Site Infection (SSI)... 6,000 36 35/60 126,000
Staff RN....................................... 57.121 Denominator for Procedure....... 6,000 540 10/60 540,000
Laboratory Technician.......................... 57.123 Antimicrobial Use and Resistance 6,000 12 5/60 6,000
(AUR)-Microbiology Data Electronic
Upload Specification Tables.
Pharmacist..................................... 57.124 Antimicrobial Use and Resistance 6,000 12 5/60 6,000
(AUR)-Pharmacy Data Electronic Upload
Specification Tables.
Registered Nurse (Infection Preventionist)..... 57.125 Central Line Insertion Practices 1,000 100 25/60 41,667
Adherence Monitoring.
Registered Nurse (Infection Preventionist)..... 57.126 MDRO or CDI Infection Form...... 6,000 72 30/60 216,000
Registered Nurse (Infection Preventionist)..... 57.127 MDRO and CDI Prevention Process 6,000 24 15/60 36,000
and Outcome Measures Monthly
Monitoring.
Registered Nurse (Infection Preventionist)..... 57.128 Laboratory-identified MDRO or 6,000 240 20/60 480,000
CDI Event.
Registered Nurse (Infection Preventionist)..... 57.129 Adult Sepsis.................... 50 250 25/60 5,208
Registered Nurse (Infection Preventionist)..... 57.137 Long-Term Care Facility 350 1 1.08 378
Component--Annual Facility Survey.
Registered Nurse (Infection Preventionist)..... 57.138 Laboratory-identified MDRO or 350 12 15/60 1,050
CDI Event for LTCF.
Registered Nurse (Infection Preventionist)..... 57.139 MDRO and CDI Prevention Process 350 12 10/60 700
Measures Monthly Monitoring for LTCF.
Registered Nurse (Infection Preventionist)..... 57.140 Urinary Tract Infection (UTI) 350 14 30/60 2,450
for LTCF.
Registered Nurse (Infection Preventionist)..... 57.141 Monthly Reporting Plan for LTCF. 350 12 5/60 350
Registered Nurse (Infection Preventionist)..... 57.142 Denominators for LTCF Locations. 350 12 3.35 14,070
Registered Nurse (Infection Preventionist)..... 57.143 Prevention Process Measures 300 12 5/60 300
Monthly Monitoring for LTCF.
Registered Nurse (Infection Preventionist)..... 57.150 LTAC Annual Survey.............. 400 1 55/60 367
Registered Nurse (Infection Preventionist)..... 57.151 Rehab Annual Survey............. 1,000 1 55/60 917
Occupational Health RN/Specialist.............. 57.200 Healthcare Personnel Safety 50 1 8 400
Component Annual Facility Survey.
Occupational Health RN/Specialist.............. 57.203 Healthcare Personnel Safety 17,000 1 5/60 1,417
Monthly Reporting Plan.
Occupational Health RN/Specialist.............. 57.204 Healthcare Worker Demographic 50 200 20/60 3,333
Data.
Occupational Health RN/Specialist.............. 57.205 Exposure to Blood/Body Fluids... 50 50 1 2,500
Occupational Health RN/Specialist.............. 57.206 Healthcare Worker Prophylaxis/ 50 30 15/60 375
Treatment.
Laboratory Technician.......................... 57.207 Follow-Up Laboratory Testing.... 50 50 15/60 625
Occupational Health RN/Specialist.............. 57.210 Healthcare Worker Prophylaxis/ 50 50 10/60 417
Treatment-Influenza.
[[Page 34340]]
Medical/Clinical Laboratory Technologist....... 57.300 Hemovigilance Module Annual 500 1 2 1,000
Survey.
Medical/Clinical Laboratory Technologist....... 57.301 Hemovigilance Module Monthly 500 12 1/60 100
Reporting Plan.
Medical/Clinical Laboratory Technologist....... 57.303 Hemovigilance Module Monthly 500 12 1.17 7,020
Reporting Denominators.
Medical/Clinical Laboratory Technologist....... 57.305 Hemovigilance Incident.......... 500 10 10/60 833
Medical/Clinical Laboratory Technologist....... 57.306 Hemovigilance Module Annual 200 1 35/60 117
Survey--Non-acute care facility.
Medical/Clinical Laboratory Technologist....... 57.307 Hemovigilance Adverse Reaction-- 500 4 25/60 833
Acute Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.308 Hemovigilance Adverse Reaction-- 500 4 25/60 833
Allergic Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.309 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Delayed Hemolytic Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.310 Hemovigilance Adverse Reaction-- 500 2 25/60 417
Delayed Serologic Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.311 Hemovigilance Adverse Reaction-- 500 4 25/60 833
Febrile Non-hemolytic Transfusion
Reaction.
Medical/Clinical Laboratory Technologist....... 57.312 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Hypotensive Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.313 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Infection.
Medical/Clinical Laboratory Technologist....... 57.314 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Post Transfusion Purpura.
Medical/Clinical Laboratory Technologist....... 57.315 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Transfusion Associated Dyspnea.
Medical/Clinical Laboratory Technologist....... 57.316 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Transfusion Associated Graft vs. Host
Disease.
Medical/Clinical Laboratory Technologist....... 57.317 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Transfusion Related Acute Lung Injury.
Medical/Clinical Laboratory Technologist....... 57.318 Hemovigilance Adverse Reaction-- 500 2 25/60 417
Transfusion Associated Circulatory
Overload.
Medical/Clinical Laboratory Technologist....... 57.319 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Unknown Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.320 Hemovigilance Adverse Reaction-- 500 1 25/60 208
Other Transfusion Reaction.
Medical/Clinical Laboratory Technologist....... 57.400 Patient Safety Component--Annual 5,000 1 5/60 417
Facility Survey for Ambulatory Surgery
Center (ASC).
Staff RN....................................... 57.401 Outpatient Procedure Component-- 5,000 12 15/60 15,000
Monthly Reporting Plan.
Staff RN....................................... 57.402 Outpatient Procedure Component 5,000 25 40/60 83,333
Event.
Staff RN....................................... 57.403 Outpatient Procedure Component-- 5,000 12 40/60 40,000
Monthly Denominators and Summary.
Staff RN....................................... 57.500 Outpatient Dialysis Center 6,500 1 2.0 13,000
Practices Survey.
Registered Nurse (Infection Preventionist)..... 57.501 Dialysis Monthly Reporting Plan. 6,500 12 5/60 6,500
Staff RN....................................... 57.502 Dialysis Event.................. 6,500 60 25/60 162,500
Staff RN....................................... 57.503 Denominator for Outpatient 6,500 12 10/60 13,000
Dialysis.
[[Page 34341]]
Staff RN....................................... 57.504 Prevention Process Measures 1,500 12 1.25 22,500
Monthly Monitoring for Dialysis.
Staff RN....................................... 57.505 Dialysis Patient Influenza 325 75 10/60 4,063
Vaccination.
Staff RN....................................... 57.506 Dialysis Patient Influenza 325 5 10/60 271
Vaccination Denominator.
Staff RN....................................... 57.507 Home Dialysis Center Practices 600 1 25/60 250
Survey.
Total.......................................... ....................................... 5,110,716
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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. 2016-12701 Filed 5-27-16; 8:45 am]
BILLING CODE 4163-18-P