Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-0666; Docket No. CDC-2020-0065]

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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the CDC's National Healthcare Safety Network (NHSN). 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.

DATES:

CDC must receive written comments on or before August 14, 2020.

ADDRESSES:

You may submit comments, identified by Docket No. CDC-2020-0065 by any of the following methods:

•

Federal eRulemaking Portal: Regulations.gov.

Follow the instructions for submitting comments.

•

Mail:

Jeffrey M. Zirger, 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. CDC will post, without change, all relevant comments to

Regulations.gov.

Please note: Submit all comments 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 Jeffrey M. Zirger, 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 the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. 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;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected; and

4. 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 submissions of responses.

5. Assess information collection costs.

Proposed Project

National Healthcare Safety Network (NHSN) (OMB Control No. 0920-0666)—Revision—National Center for Emerging and Zoonotic Infection Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Division of Healthcare Quality Promotion (DHQP), National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC) collects data from healthcare facilities in the National Healthcare Safety Network (NHSN) under OMB Control Number 0920-0666. NHSN provides facilities, states, regions, and the nation with data necessary to identify problem areas, measure the progress of prevention efforts, and ultimately eliminate healthcare-associated infections (HAIs) nationwide. NHSN allows healthcare facilities to track blood safety errors and various healthcare-associated infection prevention practice methods such as healthcare personnel influenza vaccine status and corresponding infection control adherence rates.

NHSN currently has six components: Patient Safety (PS), Healthcare Personnel Safety (HPS), Biovigilance (BV), Long-Term Care Facility (LTCF), Outpatient Procedure (OPC), and the Dialysis Component. NHSN's planned Neonatal Component is expected to launch during the winter of 2020/2021. This component will focus on premature neonates and the healthcare-associated events that occur as a result of their prematurity. This component will be released with one module, which includes Late Onset-Sepsis and Meningitis. Late-onset sepsis (LOS) and Meningitis are common complications of extreme prematurity. These infections are usually serious, causing a prolongation of hospital stay, increased cost, and risk of morbidity and mortality. The data for this module will be electronically submitted, and manual data entry will not be available. This will allow more hospital personnel to be available to care for patients and will reduce annual burden across healthcare facilities. Additionally, LOS data will be utilized for prevention initiatives.

Data reported under the Patient Safety Component are used to determine the magnitude of the healthcare-associated adverse events and trends in the rates of the events, in the distribution of pathogens, and in the adherence to prevention practices. Data will help detect changes in the epidemiology of adverse events resulting from new medical therapies and changing patient risks. Additionally, reported data is being used to describe the epidemiology of antimicrobial use and resistance and to better understand the relationship of antimicrobial therapy to this rising problem.

Approved as a New Emergency ICR (National Healthcare Safety Network (NHSN) Patient Impact Module for Coronavirus (COVID-19) Surveillance in Healthcare Facilities, OMB Control No. 0920-1290), NHSN launched a COVID-19 Module in the Patient Safety Component on March 27th, 2020. This Module is designed to collect facility-level COVID-19 data on cases, deaths, capacity, healthcare worker staffing shortages, and personal protective equipment and supplies from hospitals on a daily basis. Facility-level data collected through NSHN as part of the COVID-19 Module are being made available to a broader set of Federal, state, and local agency data users than data typically collected by NHSN. Specifically, COVID-19 data at the state, county, territory, and facility level submitted to NHSN will continue to be used for public health emergency response activities by CDC's emergency COVID-19 response, by the U.S. Department of Health and Human Services' (HHS') COVID-19 tracking system maintained in the Office of the Assistant Secretary of Preparedness and Response as part of the National Response Coordination Center at the Federal Emergency Management Agency (FEMA), and by the White House Coronavirus Task Force.

Under the Healthcare Personnel Safety Component, protocols and data on events—both positive and adverse—are used to determine (1) the magnitude of adverse events in healthcare personnel, and (2) compliance with immunization and sharps injuries safety guidelines. Under the Biovigilance Component, data on adverse reactions and incidents associated with blood transfusions are reported and analyzed to provide national estimates of adverse reactions and incidents. Under the Long-Term Care Facility Component, data is captured from skilled nursing facilities. Reporting methods under the LTCF component have been created by using forms from the PS Component as a model with modifications to specifically address the specific characteristics of LTCF residents and the unique data needs of these facilities reporting into NHSN. A new form has been introduced for field testing- Respiratory Tract Infection (RTI)—not to be used by NHSN users, but as part of an EIP project with 4 EIP sites. Form title will be

Denominators for Healthcare Associated Infections (HAIs): Respiratory Tract Infections.

The purpose of this form is to allow testing prior to introducing a new module and forms to NHSN users. The CDC's Epidemiology Research & Innovations Branch (ERIB) team will use the form to perform field testing of variables to explore the utilization, applicability, and data collection burden associated with these variables. This process will inform areas of improvement prior to incorporating the new module, including protocol, forms, and instructions into NHSN. The estimated burden for this form is 20 minutes, which is based on a similar denominator form. Also approved under New Emergency ICR 0920-1290, NHSN

launched a COVID-19 Module in the Long-Term Care Component April 27th, 2020. As with the COVID-19 Module in the PS Component, the LTC COVID-19 Module is designed to collect facility-level COVID-19 data on cases, deaths, capacity, healthcare worker staffing shortages, and personal protective equipment and supplies from long-term care facilities on at least a weekly basis. Facility-level data collected through NSHN as part of the COVID-19 Module are being made available to a broader set of Federal, state, and local agency data users than data typically collected by NHSN. Specifically, COVID-19 data at the state, county, territory, and facility level submitted to NHSN will continue to be used for public health emergency response activities by CDC's emergency COVID-19 response, by the U.S. Department of Health and Human Services' (HHS') COVID-19 tracking system maintained in the Office of the Assistant Secretary of Preparedness and Response as part of the National Response Coordination Center at the Federal Emergency Management Agency (FEMA), and by the White House Coronavirus Task Force.

The Dialysis Component offers a simplified user interface for dialysis users to streamline their data entry and analyses processes as well as provide options for expanding in the future to include dialysis surveillance in settings other than outpatient facilities. The Outpatient Procedure Component (OPC) gathers data on the impact of infections and outcomes related to operative procedures performed in Ambulatory Surgery Centers (ASCs). The OPC is used to monitor two event types: Same Day Outcome Measures and Surgical Site Infections (SSIs). NHSN has increasingly served as the operating system for HAI reporting compliance through legislation established by the states. As of April 2020, 36 states, the District of Columbia and the City of Philadelphia, Pennsylvania have opted to use NHSN as their primary system for mandated reporting. Reporting compliance is completed by healthcare facilities in their respective jurisdictions, with emphasis on those states and municipalities acquiring varying consequences for failure to use NHSN. Additionally, healthcare facilities in five U.S. territories (Puerto Rico, American Samoa, the U.S. Virgin Islands, Guam, and the Northern Mariana Islands) are voluntarily reporting to NHSN. Additional territories are projected to follow with similar use of NHSN for reporting purposes.

NHSN's data is used to aid in the tracking of HAIs and guide infection prevention activities/practices that protect patients. The Centers for Medicare and Medicaid Services (CMS) and other payers use these data to determine incentives for performance at healthcare facilities across the US and surrounding territories, and members of the public may use some protected data to inform their selection among available providers. Each of these parties is dependent on the completeness and accuracy of the data. CDC and CMS work closely and are fully committed to ensuring complete and accurate reporting, which are critical for protecting patients and guiding national, state, and local prevention priorities.

CMS collects some HAI data and healthcare personnel influenza vaccination summary data, which is done on a voluntary basis as part of its Fee-for-Service Medicare quality reporting programs, while others may report data required by a federal mandate. Facilities that fail to report quality measure data are subject to partial payment reduction in the applicable Medicare Fee-for-Service payment system. CMS links their quality reporting to payment for Medicare-eligible acute care hospitals, inpatient rehabilitation facilities, long-term acute care facilities, oncology hospitals, inpatient psychiatric facilities, dialysis facilities, and ambulatory surgery centers. Facilities report HAI data and healthcare personnel influenza vaccination summary data to CMS via NHSN as part of CMS's quality reporting programs to receive full payment. Still, many healthcare facilities, even in states without HAI reporting legislation, submit limited HAI data to NHSN voluntarily. NHSN's data collection updates continue to support the incentive programs managed by CMS. For example, survey questions support requirements for CMS' quality reporting programs. Additionally, CDC has collaborated with CMS on a voluntary National Nursing Home Quality Collaborative, which focuses on recruiting nursing homes to report HAI data to NHSN and to retain their continued participation. This project has resulted in a significant increase in long-term care facilities reporting to NHSN.

The ICR previously approved in December of 2019 for 5,352,360 responses; 3,113,631 burden hours. The proposed changes in this new ICR include revisions to eight data collection forms and the addition of ten new forms for a total of 86 proposed data collection forms. In this Revision, CDC requests OMB approval for an estimated 2,365,743 annual burden hours.

Estimated Annualized Burden Hours

Form No. & name

Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(min./hour)

Total burden

(hours)

57.100 NHSN Registration Form

2,000

1

5/60

167

57.101 Facility Contact Information

2,000

1

10/60

333

57.103 Patient Safety Component—Annual Hospital Survey

6,765

1

55/60

6,201

57.105 Group Contact Information

1,000

1

5/60

83

57.106 Patient Safety Monthly Reporting Plan

7,821

12

15/60

23,463

57.108 Primary Bloodstream Infection (BSI)

5,775

5

38/60

18,288

57.111 Pneumonia (PNEU)

1,800

2

30/60

18,288

57.112 Ventilator-Associated Event

5,463

8

28/60

20,395

57.113 Pediatric Ventilator-Associated Event (PedVAE)

334

1

30/60

167

57.114 Urinary Tract Infection (UTI)

6,000

5

20/60

10,000

57.115 Custom Event

600

91

35/60

31,850

57.116 Denominators for Neonatal Intensive Care Unit (NICU)

1,100

12

4/60

880

57.117 Denominators for Specialty Care Area (SCA)/Oncology (ONC)

500

12

5/60

503

57.118 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA)

5,500

60

5/60

27,665

57.120 Surgical Site Infection (SSI)

6,000

9

35/60

31,500

57.121 Denominator for Procedure

6,000

602

10/60

602,000

57.122 HAI Progress Report State Health Department Survey

55

1

28/60

26

57.123 Antimicrobial Use and Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables

2,500

12

5/60

1,500

57.124 Antimicrobial Use and Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables

2,000

12

5/60

2,000

57.125 Central Line Insertion Practices Adherence Monitoring

500

213

25/60

44,375

57.126 MDRO or CDI Infection Form

720

12

30/60

3,960

57.127 MDRO and CDI Prevention Process and Outcome Measures Monthly Monitoring

5,500

29

15/60

39,875

57.128 Laboratory-identified MDRO or CDI Event

4,800

79

20/60

126,400

57.129 Adult Sepsis

50

250

25/60

5,208

57.130 COVID-19 Module: Patient Impact and Hospital Capacity

3,117

540

25/60

701,325

57.131 COVID-19 Module: Healthcare Worker Staffing

3,117

540

25/60

701,325

57.132 COVID-19 Module: Supplies

3,117

540

25/60

701,325

57.135 Late Onset Sepsis/Meningitis Denominator Form: Data Table for monthly electronic upload

300

12

5/60

300

57.136 Late Onset Sepsis/Meningitis Event Form: Data Table for Monthly Electronic Upload

300

4

5/60

100

57.137 Long-Term Care Facility Component—Annual Facility Survey

3,079

1

1/60

51

57.138 Laboratory-identified MDRO or CDI Event for LTCF

1,998

24

12/60

9,590

57.139 MDRO and CDI Prevention Process Measures Monthly Monitoring for LTCF

1,998

12

12/60

4,795

57.140 Urinary Tract Infection (UTI) for LTCF

339

12

12/60

814

57.141 Monthly Reporting Plan for LTCF

2,011

12

12/60

4,826

57.142 Denominators for LTCF Locations

339

12

250/60

814

57.143 Prevention Process Measures Monthly Monitoring for LTCF

130

12

12/60

312

57.144 LTCF COVID-19 Module: Resident Impact and Facility Capacity

14,674

26

20/60

127,175

57.145 LTCF COVID-19 Module: Staff and Personnel Impact

14,674

26

15/60

95,381

57.146 LTCF COVID-19 Module: Supplies and PPE

14,674

26

5/60

31,794

57.147 LTCF COVID-19 Module: Ventilator Capacity and Supplies

14,674

26

5/60

31,794

57.150 LTAC Annual Survey

620

1

10/60

10

57.151 Rehab Annual Survey

1,340

1

10/60

625

57.200 Healthcare Personnel Safety Component Annual Facility Survey

50

1

480/60

400

57.203 Healthcare Personnel Safety Monthly Reporting Plan

1

5/60

57.204 Healthcare Worker Demographic Data

50

200

20/60

3,333

57.205 Exposure to Blood/Body Fluids

50

50

60/60

2,500

57.206 Healthcare Worker Prophylaxis/Treatment

50

30

15/60

375

57.207 Follow-Up Laboratory Testing

50

50

15/60

625

57.210 Healthcare Worker Prophylaxis/Treatment-Influenza

50

50

10/60

417

57.300 Hemovigilance Module Annual Survey

500

1

85/60

708

57.301 Hemovigilance Module Monthly Reporting Plan

500

12

1/60

100

57.303 Hemovigilance Module Monthly Reporting Denominators

500

12

70/60

7,000

57.305 Hemovigilance Incident

500

10

10/60

833

57.306 Hemovigilance Module Annual Survey—Non-acute care facility

500

1

35/60

292

57.307 Hemovigilance Adverse Reaction—Acute Hemolytic Transfusion Reaction

500

4

20/60

667

57.308 Hemovigilance Adverse Reaction—Allergic Transfusion Reaction

500

4

20/60

667

57.309 Hemovigilance Adverse Reaction—Delayed Hemolytic Transfusion Reaction

500

1

20/60

167

57.310 Hemovigilance Adverse Reaction—Delayed Serologic Transfusion Reaction

500

2

20/60

333

57.311 Hemovigilance Adverse Reaction—Febrile Non-hemolytic Transfusion Reaction

500

4

20/60

667

57.312 Hemovigilance Adverse Reaction—Hypotensive Transfusion Reaction

500

1

20/60

167

57.313 Hemovigilance Adverse Reaction—Infection

500

1

20/60

167

57.314 Hemovigilance Adverse Reaction—Post Transfusion Purpura

500

1

20/60

167

57.315 Hemovigilance Adverse Reaction—Transfusion Associated Dyspnea

500

1

20/60

167

57.316 Hemovigilance Adverse Reaction—Transfusion Associated Graft vs. Host Disease

500

1

20/60

167

57.317 Hemovigilance Adverse Reaction—Transfusion Related Acute Lung Injury

500

1

20/60

167

57.318 Hemovigilance Adverse Reaction—Transfusion Associated Circulatory Overload

500

2

20/60

333

57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction

500

1

20/60

167

57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction

500

1

20/60

167

57.400 Outpatient Procedure Component—Annual Facility Survey

700

1

10/60

117

57.401 Outpatient Procedure Component—Monthly Reporting Plan

700

12

15/60

2,100

57.402 Outpatient Procedure Component Same Day Outcome Measures

200

1

40/60

133

57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures

200

400

40/60

53,333

57.404 Outpatient Procedure Component—SSI Denominator

700

100

40/60

46,667

57.405 Outpatient Procedure Component—Surgical Site (SSI) Event

700

5

40/60

2,333

57.500 Outpatient Dialysis Center Practices Survey

7,200

1

127/60

15,240

57.501 Dialysis Monthly Reporting Plan

7,200

12

5/60

7,200

57.502 Dialysis Event

7,200

30

25/60

90,000

57.503 Denominator for Outpatient Dialysis

7,200

30

10/60

14,400

57.504 Prevention Process Measures Monthly Monitoring for Dialysis

1,730

12

75/60

25,950

57.505 Dialysis Patient Influenza Vaccination

615

50

10/60

5,125

57.506 Dialysis Patient Influenza Vaccination Denominator

615

5

10/60

513

57.507 Home Dialysis Center Practices Survey

430

1

30/60

215

Total

2,365,743

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.

[FR Doc. 2020-12809 Filed 6-12-20; 8:45 am]

BILLING CODE 4163-18-P