NonSubstantive Change Request Justification

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: August 19, 2024

The Centers for Disease Control and Prevention (CDC), Division of Healthcare Quality Promotion (DHQP) requests approval for non-substantive changes to add two new data collection forms, revisions to two currently approved data collection instruments to the National Healthcare Safety Network (NHSN) Coronavirus (COVID-19) Surveillance in Healthcare Facilities (OMB Control No. 0920-1317). We are requesting a determination of this review by September 18, 2024, as these revisions will go into effect on September 30, 2024 prior to respiratory virus season.

These non-substantive changes are minor and do not constitute more than a 10% change to the original OMB package (0920-1317). The data collection for which approval for changes are being sought include:

1. 57.216 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents

2. 57.217 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel

3. 57.218 Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities

4. 57.219 Healthcare Personnel COVID-19 Vaccination Cumulative Summary

The new data collection instruments and changes to the currently approved instruments, including associated burden, are described below.

1. 57.216 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents

New data collection instrument: Form 57.216 allows facilities to enter vaccination data on individual residents at long-term care facilities. Data collection on this form is optional, but NHSN recommends that facilities use this form to improve the accuracy of reporting vaccine data. Facilities have the option to report their vaccination data via this form or the weekly summary form (57.218).

The optional person level form was implemented to make vaccination reporting more accurate, streamlined, and efficient for users. NHSN uses the person-level data to calculate and populate the weekly facility-level totals in the corresponding weekly vaccination summary form (57.218), on behalf of the user. The capability to use this data collection tool became available to facilities in May 2022. NHSN believed this form was approved under the vaccine waiver; however, we recently discovered that it is not covered under the waiver, and we are thus requesting approval for the form.

Facilities can manually input the information into NHSN, or they may upload a comma-separated value file (.csv import).

Time Burden: 60 minutes

Change in Time Burden: New data collection.

2. 57.217 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel

New data collection instrument: Form 57.217 allows facilities to enter vaccination data on individual healthcare personnel. Data collection on this form is optional, but NHSN recommends that facilities use this form to improve the accuracy of reporting vaccine data. Facilities have the option to reporting their vaccination data via this form or the weekly summary form (57.219).

The optional person level form was implemented to make vaccination reporting more accurate, streamlined, and efficient for users. NHSN uses the person-level data to calculate and populate the weekly facility-level totals in the corresponding weekly vaccination summary form (57.219), on behalf of the user. The capability to use this data collection tool became available to facilities in September 2023. NHSN believed this form was approved under the vaccine waiver; however, we recently discovered that it is not covered under the waiver, and we are thus requesting approval for the form.

Facilities can manually input the information into NHSN, or they may upload a comma-separated value file (.csv import).

Time Burden: 60 minutes

Change in Time Burden: New data collection.

3. 57.218 Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities

The updates to form 57.218 are only verbiage updates to increase clarity an understanding for the user, no additional variables have been included nor have any of the definitions changed. Updating the language will allow for a condensed and simplified reporting process for long term care component users which will help to ensure accurate data is being reported.

The form burden is also being updated to obtain approval for the multiple ways in which Long-Term Care Facilities have historically been able to report the data collected on form 57.218. Facilities can manually input the information into NHSN, or they may upload a comma-separated value file (.csv import).

The full list of updates to the data collection form are listed in the below crosswalk.  

Type of Change	Changed From	Changed To	Justification
Addition	No season listed	Flu / Respiratory Virus Season YYYY-YYYY	Automatically populates to indicate the Flu / Respiratory Virus Season. Clarifies the timeframe of data collection for NHSN users
Revision	**Number of residents in Question #3a who are up to date with COVID-19 vaccines	3ai**Number of residents in Question #3a who received the up to date COVID-19 vaccine 14 days or more before the positive test	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection.
Revision	**Number of residents in Question #3b who have received this season’s annual influenza vaccine	3bi. **Number of residents in Question #3b who received this season’s annual influenza vaccine (YYYY-YYYY) 14 days or more before the positive test	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	**Number of residents in Question #3c who have received RSV vaccine	3ci. **Number of residents in Question #3c who received RSV vaccine 14 days or more before the positive test	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	4a. *COVID-19: Residents hospitalized within 10 days after a positive test	4a. *COVID-19: Residents hospitalized this week, and had a positive test in the last 10 days	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	**Number of residents in Question #4a who are up to date with COVID-19 vaccines	4ai. **Number of residents in Question #4a who received the up to date COVID-19 vaccine 14 days or more before the positive test	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	4b. *Influenza: Residents hospitalized within 10 days after a positive test	4b. Influenza: Residents hospitalized this week, and had a positive test in the last 10 days	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	**Number of residents in Question #4b who have received this season’s annual influenza vaccine	4bi. **Number of residents in Question #4b who received this season’s annual influenza vaccine (YYYY-YYYY) 14 days or more before the positive test	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	4c. *RSV: Residents hospitalized within 10 days after a positive test	4c. RSV: Residents hospitalized this week, and had a positive test in the last 10 days	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection
Revision	** Number of residents in Question #4c who have received RSV vaccine	4ci. ** Number of residents in Question #4c who received RSV vaccine 14 days or more before the positive test	Rephrasing of the question clarifies to NHSN user what is being asked and how to provide best response for data collection

Time Burden: 25 minutes for manual, 20 minutes for .csv

Change in Time Burden: 20 minutes for .csv

4. 57.219 Healthcare Personnel COVID-19 Vaccination Cumulative Summary

The form burden is being updated to obtain approval for the multiple ways in which facilities have historically been able to report the data collected on the form. Facilities can manually input the information into NHSN, or they may upload a comma-separated value file (.csv import).

Time Burden: 25 minutes for manual, 20 minutes for .csv

Change in Time Burden: 20 minutes for .csv

Burden Estimates – 0920-1317

As a result of proposed changes to the form, the estimated annualized burden is expected to decrease by 1,660,228 hours, from 4,426,312 to 2,766,084.

Form Number & Name	No. of Respondents	No. Responses per Respondent	Avg. Burden per response (in hrs.)	Total Burden  (in hrs.)	Hourly Wage Rate	Total Respondent Cost	Type of Respondent
57.216 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (manual)	1,669	52	60/60	86,788	$47.53	$4,125,034	Microbiologist
57.216 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Long-Term Care Residents (.csv)	167	52	60/60	8,684	$50.12	$435,242	Information Technology
57.217 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (manual)	96	52	60/60	4,992	$47.53	$237,270	Microbiologist
57.217 Optional Person Level Reporting of Weekly COVID-19 Vaccination for Healthcare Personnel (.csv)	106	52	60/60	5,512	$50.12	$276,261	Information Technology
57.218 Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities (manual entry)	10,500	52	25/60	227,500	$47.53	$10,813,075	Microbiologist
57.218 Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities (.csv)	6,000	52	20/60	104,000	$50.12	$5,420,480	Information Technology
57.219 Healthcare Personnel COVID-19 Vaccination Cumulative Summary (manual entry)	11,360	12	45/60	102,240	$47.53	$4,859,467	Microbiologist
57.219 Healthcare Personnel COVID-19 Vaccination Cumulative Summary (.csv)	4,107	12	40/60	32,856	$50.12	$1,646,743	Information Technology
Total Burden Hours for 0920-1317  2,766,084