Proposed Data Collection Submitted for Public Comment and Recommendations
Federal RegisterMay 31, 2016
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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.
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
Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
omb@cdc.gov.
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
Type of respondents
Form name
Number of
respondents
Number of
responses per Respondent
Avg. burden per response (in hrs.)
Total burden (in hrs.)
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 Hospital Survey
5,000
1
55/60
4,583
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 Plan
6,000
12
15/60
18,000
Registered Nurse (Infection Preventionist)
57.108 Primary Bloodstream Infection (BSI)
6,000
44
30/60
132,000
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 Event (PedVAE)
2,000
120
25/60
100,000
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 Intensive Care Unit (NICU)
6,000
9
3
162,000
Staff RN
57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)
6,000
9
5
270,000
Staff RN
57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)
6,000
60
5
1,800,000
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 (AUR)-Microbiology Data Electronic Upload Specification Tables
6,000
12
5/60
6,000
Pharmacist
57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables
6,000
12
5/60
6,000
Registered Nurse (Infection Preventionist)
57.125 Central Line Insertion Practices Adherence Monitoring
1,000
100
25/60
41,667
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 and Outcome Measures Monthly Monitoring
6,000
24
15/60
36,000
Registered Nurse (Infection Preventionist)
57.128 Laboratory-identified MDRO or CDI Event
6,000
240
20/60
480,000
Registered Nurse (Infection Preventionist)
57.129 Adult Sepsis
50
250
25/60
5,208
Registered Nurse (Infection Preventionist)
57.137 Long-Term Care Facility Component—Annual Facility Survey
350
1
1.08
378
Registered Nurse (Infection Preventionist)
57.138 Laboratory-identified MDRO or CDI Event for LTCF
350
12
15/60
1,050
Registered Nurse (Infection Preventionist)
57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF
350
12
10/60
700
Registered Nurse (Infection Preventionist)
57.140 Urinary Tract Infection (UTI) for LTCF
350
14
30/60
2,450
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 Monthly Monitoring for LTCF
300
12
5/60
300
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 Component Annual Facility Survey
50
1
8
400
Occupational Health RN/Specialist
57.203 Healthcare Personnel Safety Monthly Reporting Plan
17,000
1
5/60
1,417
Occupational Health RN/Specialist
57.204 Healthcare Worker Demographic Data
50
200
20/60
3,333
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/Treatment
50
30
15/60
375
Laboratory Technician
57.207 Follow-Up Laboratory Testing
50
50
15/60
625
Occupational Health RN/Specialist
57.210 Healthcare Worker Prophylaxis/Treatment-Influenza
50
50
10/60
417
Medical/Clinical Laboratory Technologist
57.300 Hemovigilance Module Annual Survey
500
1
2
1,000
Medical/Clinical Laboratory Technologist
57.301 Hemovigilance Module Monthly Reporting Plan
500
12
1/60
100
Medical/Clinical Laboratory Technologist
57.303 Hemovigilance Module Monthly Reporting Denominators
500
12
1.17
7,020
Medical/Clinical Laboratory Technologist
57.305 Hemovigilance Incident
500
10
10/60
833
Medical/Clinical Laboratory Technologist
57.306 Hemovigilance Module Annual Survey—Non-acute care facility
200
1
35/60
117
Medical/Clinical Laboratory Technologist
57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction
500
4
25/60
833
Medical/Clinical Laboratory Technologist
57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction
500
4
25/60
833
Medical/Clinical Laboratory Technologist
57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction
500
2
25/60
417
Medical/Clinical Laboratory Technologist
57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction
500
4
25/60
833
Medical/Clinical Laboratory Technologist
57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.313 Hemovigilance Adverse Reaction—Infection
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload
500
2
25/60
417
Medical/Clinical Laboratory Technologist
57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction
500
1
25/60
208
Medical/Clinical Laboratory Technologist
57.400 Patient Safety Component—Annual Facility Survey for Ambulatory Surgery Center (ASC)
5,000
1
5/60
417
Staff RN
57.401 Outpatient Procedure Component—Monthly Reporting Plan
5,000
12
15/60
15,000
Staff RN
57.402 Outpatient Procedure Component Event
5,000
25
40/60
83,333
Staff RN
57.403 Outpatient Procedure Component—Monthly Denominators and Summary
5,000
12
40/60
40,000
Staff RN
57.500 Outpatient Dialysis Center Practices Survey
6,500
1
2.0
13,000
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 Dialysis
6,500
12
10/60
13,000
Staff RN
57.504 Prevention Process Measures Monthly Monitoring for Dialysis
1,500
12
1.25
22,500
Staff RN
57.505 Dialysis Patient Influenza Vaccination
325
75
10/60
4,063
Staff RN
57.506 Dialysis Patient Influenza Vaccination Denominator
325
5
10/60
271
Staff RN
57.507 Home Dialysis Center Practices Survey
600
1
25/60
250
Total
5,110,716
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
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