NonSubstantive Change Request Justification

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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