Change Request Memo_07SEP2023

Change Memo for

National Healthcare Safety Network (NHSN)

Surveillance in Healthcare Facilities

(OMB Control Nos. 0920-1317)

Expiration Date: 03/31/2026

Program Contact

Paula Farrell

Surveillance Branch

Division of Healthcare Quality Promotion

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

Atlanta, Georgia 30333

Phone: 404-498-4019 

Email: [email protected]

Submission Date: September 1, 2023

The Centers for Disease Control and Prevention (CDC), Division of Healthcare Quality Promotion (DHQP) requests approval of a non-substantive change to three data collection instruments in National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) Surveillance in Healthcare Facilities (OMB Control No. 0920-1317).

1. Hospital COVID-19 Data Collection Form

2. Weekly Vaccination Cumulative Summary for Residents of Long-Term Care Facilities (57.218)

3. COVID-19 and Respiratory Infections Module Long Term Care Facility Resident Impact and Facility Capacity Pathway Form (57.144)

The changes to the forms and associated burden are described below.

Patient Safety Component, COVID-19 Module

1. The COVID-19 Hospital Data Form currently collects data elements to help the Federal government understand health care system stress, capacity, capabilities, and the number of patients hospitalized due to COVID-19. Data elements may be required or optional and may be associated with a specific cadence. All current data elements will remain on the form with the addition of optional data elements regarding RSV and influenza. Detailed information and the breakdown and descriptions of current required, optional, and federally inactive data elements can be found in the COVID-19 Guidance for Hospital Reporting and FAQs for Hospitals, Hospital Laboratory, and Acute Care Facility Data Reporting: https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf

The COVID-19 pandemic has underscored the public health threat of respiratory pathogens and highlighted the need for comprehensive, real-time data for prevention and response purposes. Since March 29, 2020, the U.S. government has been collecting data from hospitals and states to understand health care system stress, capacity, capabilities, and the number of patients hospitalized due to COVID-19, and since December 15, 2022, this data has been reported to NHSN.

The proposed changes will expand the data collection form to include optional data fields for reporting adult and pediatric Influenza and Respiratory Syncytial Virus Infection (RSV) new admissions, hospitalized patients, and hospitalized ICU patients. Seasonal Influenza and Respiratory Syncytial Virus Infection (RSV) can result in substantial burden on hospitals. The addition of these optional data fields can be used to improve situational awareness of severe respiratory illness, make forecasts, help direct resources to address the potential increased impact of flu, COVID-19, and RSV co-circulation and inform guidance and recommendations for public health professionals, clinicians, and the general public. Understanding influenza and RSV hospitalizations and admissions can also help to understand potential strains on the PPE supply chain.

Breakdown of data between adult and pediatric populations are used to understand drivers of hospitalizations rates and monitor changes in hospitalization rates among different populations. Adult and pediatric influenza admission, hospitalizations, and ICU hospitalizations data during respiratory virus surges are used to monitor and take action related to hospital bed availability, especially related to pediatric bed and pediatric ICU availability. These data provide a high degree of utility during hospital occupancy surges.

Time Burden: estimate 90 minutes to complete the form

Change in Time Burden: Burden increased by 18 minutes  

Long-Term Care Component, COVID-19 Module

1. The Weekly Vaccination Cumulative Summary for Residents of Long-Term Care Facilities form (57.218) is the optional Person-Level Vaccination Form for Residents. It was developed to assist facilities with managing and tracking COVID-19 vaccination data for residents and feeding the data into the person-level vaccination data directly in NHSN. The weekly summary totals are automatically calculated and entered on the Person-Level Summary from the main Weekly COVID-19 Vaccination Module - Residents by the Application. This form is being modified based on our analysis of expanded vaccination data collection efforts to include RSV and influenza. The data elements mentioned earlier will remain on the form along with the addition of the optional RSV and influenza tab. The modification to the Weekly Cumulative Summary for Residents of Long-Term Care Facilities form will include adding RSV and Influenza vaccination tabs. This way, we will be able to provide one place for facilities to enter RSV and influenza data and NHSN will be able collect these data. The data submitted here populates in the new summary RSV/Flu weekly vaccination form. The additional data elements will include questions to obtain 1) the number of residents in question #1 who are up to date with Influenza vaccination for current season and 2) the number of residents in question #1 who are up to date with RSV vaccination under the RSV/Flu tab. Only optional aggregate weekly counts for the RSV and influenza elements listed above will be included. The added module will be named Weekly RSV/Influenza Vaccination Cumulative Summary for Residents of Long-Term Care Facilities to appropriately encompass the additional optional RSV/Flu data elements.

With the addition of optional data collection for RSV and influenza, it will improve the Vaccination surveillance in long-term care facilities and creates the ability to detect change in virus spread and outbreaks in real time so that education efforts can be provided to the long-term care facilities expeditiously. These data will also allow for collection and analyses to be conducted in relation to up to date vaccination status as well as vaccine effectiveness studies. With the addition of the proposed data elements, more evidence-based practice vaccine effectiveness studies can be conducted among this population regarding up-to-date status for RSV and influenza vaccines. RSV and Influenza cases were not collected on the original Weekly Vaccination Cumulative Summary for Residents of Long-Term Care Facilities form but by creating the Weekly RSV/Influenza Vaccination Cumulative Summary for Residents of Long-Term Care This will more easily highlight to users that the additional influenza and RSV questions are optional for LTCFs as well as reduce confusion regarding reporting requirements.

Facilities form, it will improve usability and understandability for the users, the application will be operationalized so all questions related to influenza and RSV will appear in a tab separate from the current up to date COVID-19 vaccination questions. This is considered a non-substantiative change to the COVID-19 module due to optional nature of the proposed data elements.

Updated Time Burden: estimate 35 minutes to complete the form. 

Change in Time Burden: increased by 5 minutes. 

2. The Resident Impact and Facility Capacity (RIFC) Pathway form (57.144), which is part of the LTCF COVID-19 Module, collects data on the number of newly positive COVID-19 cases among residents i long-term care facilities (LTCF) weekly (non-cumulative number). LTCFs only report new COVID-19 cases since the last time data were reported to the RIFC pathway. The RIFC form also collects information regarding: 1) COVID-19 vaccination status of newly COVID-19 positive residents, 2) hospitalizations in residents with a positive COVID-19 test, 3) hospitalizations in residents with a positive COVID-19 test and an up-to-date vaccination status, and 4) resident deaths.

All the above data elements will remain on the form with the addition of OPTIONAL data elements regarding influenza and respiratory syncytial virus (RSV). The additional elements will only collect data on newly positive laboratory cases for influenza and RSV with a subset of vaccination status and hospitalizations. NO data on signs and symptoms, treatment, deaths, etc. will be included with this update. Only OPTIONAL aggregate weekly counts for the Influenza and RSV elements listed above will be included.

The module will be renamed to the COVID-19 and Respiratory Tract Infections Module from the COVID-19 Module in order to appropriately encompass the additional OPTIONAL data elements.

The addition of OPTIONAL data collection for laboratory identified influenza and RSV will improve RTI surveillance in LTCFs and allow for increased awareness of outbreaks and trends in real-time so that outreach to LTCFs can be implemented quickly.

These data will also allow for analyses to be conducted in relation to morbidity and severity of disease as well as vaccine effectiveness studies. With the addition of the proposed data elements, more robust vaccine effectiveness studies can be conducted especially since this population has a high vaccination rate.

Influenza positive cases were collected on the original RIFC form at the beginning of the pandemic given the concern that coinfection leads to more severe disease. As COVID-19 cases have continued to rise, re-introducing this data element is critical.

In order to improve usability and understandability for the users, the application will be operationalized so all questions related to influenza and RSV will appear in a tab separate from the mandated COVID-19 Surveillance questions. This will more easily highlight to users that the additional influenza and RSV questions are optional for LTCFs as well as reduce confusion regarding reporting requirements. Facilities can choose which weeks or days they would like to report these data, they are not required to commit to optionally report on a specified cadence/frequency. This is considered a non-substantiative change to the COVID-19 module due to optional nature of the proposed data elements.

Time Burden: Estimate 25 minutes to complete the form. 

Change in Time Burden: Increased by 10 minutes for only those choosing to optionally report.

Justification:

All CMS-certified acute care facilities are required to enter COVID-19 data into the NHSN user application. The suggested changes to the Hospital COVID-19 Data Collection Form to add the optional influenza and RSV questions will easily highlight to users that the additional influenza and RSV questions are optional for hospitals, as well as reduce confusion regarding reporting requirements. Facilities can choose which weeks or days they would like to report these data, they are not required to commit to optionally report on a specified cadence/frequency.

All CMS-certified Long Term Care facilities are required to enter COVID-19 vaccination data into the NHSN user application. The suggested changes to add RSV, PNUEMO, and FLU Vaccination questions on the Person-Level Vaccination Form and Summary Form (51.218) for Residents (only) and RSV and influenza to the COVID-19 and Respiratory Infections Module Long Term Care Facility Resident Impact and Facility Capacity Pathway Form (57.144) are based on our analysis of compiling vaccine information on one form to simplify vaccine reporting.

Burden Estimates – 0920-1317

Form Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden (in hrs.)
COVID-19 Hospital Data Form Hospitals (excluding Psychiatric and Rehabilitation Facilities)	5200	365	90/60	2,847,000
COVID-19 Hospital Data Form (Psychiatric and Rehabilitation Facilities)	870	1	90/60	1,305
Weekly Vaccination Cumulative Summary for Residents of Long-Term Care Facilities (57.218)	15,925	52	35/60	483,058
COVID-19 and Respiratory Infections Module Long Term Care Facility Resident Impact and Facility Capacity Pathway Form (57.144)	16,500 (approximate)	52 (weekly reporting)	25/60	357,500