Proposed Data Collection Submitted for Public Comment and Recommendations

Federal Register, Volume 81 Issue 104 (Tuesday, May 31, 2016)

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: 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

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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).

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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.

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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.

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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