Non-Substantive Change Request Justification 26APR2024

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: ujb1@cdc.gov

Submission Date: April 25, 2024

The Centers for Disease Control and Prevention (CDC), Division of Healthcare Quality Promotion (DHQP) requests approval of a non-substantive change to the National Healthcare Safety Network (NHSN) COVID-19 OMB Package (OMB Control No. 0920-1317). The requested changes include revisions to two data collection instruments.

• 57.218 Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities

• 57.219 Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary

The changes to the forms and associated burden are described below. The changes are minor and do not constitute a change in scope to the original OMB package. The NHSN COVID-19 Modules are designed to standardize the data elements collected across the country regarding the impact of COVID-19 on healthcare facilities. Current efforts at data collection are individualized at each state and local region. In collecting standardized data, NHSN provides a vendor-neutral platform and a national lens into the burden facilities are experiencing in a way that is designed to support the public health response. NHSN is a platform that exists in nearly all acute-care hospitals, nursing homes, and dialysis facilities in the US and can provide a secure, sturdy infrastructure.

57.218 Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities

Form 57.218 Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities form is being revised to include several data elements from form 57.144 Resident Impact and Facility Capacity. This change will allow for cumulative vaccination data, as well as new COVID-19 case data to be collected on one form, as opposed to two separate forms.

Because of these revisions the form title is also changing from Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities to Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities.

Crosswalk and Justification for Changes
Type of Change	Changed From	Changed To	Justification	Impact to Burden
Addition	NA	2a. *Number of residents who are up to date with COVID-19 vaccines. 2b. *Number of residents who have received this season’s annual influenza vaccine (YYYY-YYYY) 2c. *Number of residents who received RSV vaccine	These data elements will collect the total number of residents in the facility that are up to date with the vaccine listed. This will allow for better quality data analysis as these questions will be denominator data.	Increase Add 3 required questions
Deletion	2. *Cumulative number of residents in Question #1 who are up to date with COVID-19 vaccines.	(NA field to be removed)	No longer needed with the other revisions/updates to this form.	Decrease Remove 1 required question
Addition	NA	3a. *COVID-19: Residents with a Positive Test 3ai.**Number of residents in Question #3a who received the up to date COVID-19 vaccine 14 days or more before the positive test 3b. *Influenza: Residents with a Positive Test 3bi.**Number of residents in Question #3b who have received this season’s annual influenza vaccine (YYYY-YYYY) 14 days or more before the positive test 3c. *RSV: Residents with a Positive Test 3ci.**Number of residents in Question #3c who have received RSV vaccine 14 days or more before the positive test	These data elements ae currently collected on the Resident Impact and Facility Capacity (RIFC) form within the COVID-19 Surveillance Pathways of the NHSN LTC Component. These questions provide data regarding the number of positive tests for each pathogen listed and also the vaccination status of those residents at the time they received the positive test. These data allow for analyses regarding the number of cases per week which also provides understanding of trends as well as outbreaks. This information allows for outreach to facilities with high case counts. Additionally, these data allow for analyses regarding vaccination effectiveness.	Increase Add 3 required questions and 3 conditionally required questions
Deletion	3. *Cumulative number of residents in Question #1 with other conditions	(NA field to be removed)	No longer needed with the other revisions/updates to this form.	Decrease Remove 1 required question
Addition		4a. *COVID-19: Residents hospitalized this week, and had a positive test in the last 10 days. 4ai.**Number of residents in Question #4a who received the up to date COVID-19 vaccine 14 days or more before the positive test 4b.*Influenza: Residents hospitalized this week, and has a positive test in the last 10 days 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 4c. *RSV: Residents hospitalized this week, and has a positive test in the last 10 days 4ci.**Number of residents in Question #4c who have received RSV vaccine 14 days or more before the positive test	These data elements ae currently collected on the Resident Impact and Facility Capacity (RIFC) form within the COVID-19 Surveillance Pathways of the NHSN LTC Component. These data allow for surveillance of disease severity of each pathogen. These data also provide additional information regarding residents who have been hospitalized with a recent positive test and their vaccination status at the time.	Increase Add 3 required questions and 3 conditionally required questions
Deletion	Optional Weekly RSV/Influenza Vaccination Cumulative Summary for Residents of Long-Term Care Facilities 1.*Number of residents staying in this facility for at least 1 day during the week of data collection (auto-populated from question 1 on the COVID-19 residents form). 2. Number of residents in question #1 who are up to date with Influenza vaccination for current influenza season Among those not in Question #2, reason not up to date: 2.1. Medical contraindication to influenza vaccine 2.2. Offered but declined influenza vaccine 2.3. Other/unknown influenza vaccination status 3. Number of residents in question #1 who are up to date with RSV vaccination Among those not in Question #3, reason not up to date: 3.1. Medical contraindication to RSV vaccine 3.2. Offered but declined RSV vaccine 3.3. Other/unknown RSV vaccination status	(NA field to be removed)	No longer needed with the other revisions/updates to this form	Decrease Dependent on facility as fields were OPTIONAL *If facility does complete, this deletion would remove 9 questions

Justification:

Updating form 57.218 Weekly Resident COVID-19 Vaccination Cumulative Summary for Long-Term Care Facilities will allow for a more streamlined and simplified reporting process for Long Term Care Facility Component users. This change will allow for cumulative vaccination data, as well as new COVID-19 case data to be collected on one form, as opposed to two separate forms. Form 57.144 COVID-19 Module Long Term Care Facility: Resident Impact and Facility Capacity Pathway form will be retired January 1, 2025.  The updated iteration of 57.218 is scheduled to go live in September 2024. From September 1, 2024 to January 1, 2025, users will be able to edit any current data under form 57.144, but users will not be able to enter any new data under the form. Beginning January of 2025 users will only be able to view data previously captured under form 57.144 and they will not be able to edit, add, or change any previously submitted data. The retirement of form 57.144 will be submitted in the NSHN COVID-19 OMB package revision.

Time Burden:

Estimated 25 minutes to complete the data collection. The Avg. Burden per Response decreased by 50 minutes. The Number of Respondents decreased from 16,864 to 16,500. Total burden hours decreased from 483,058 to 357,500.

57.219 Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary

57.219 Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary is being revised to remove questions being asked on the form regarding the COVID-19 primary series vaccination, additional booster doses , and vaccine supply as CDC is now only collecting data on the up-to-date definition of COVID-19 vaccination status.

The title of the form is being updated from Weekly Healthcare Personnel COVID-19 Vaccination Cumulative Summary to Healthcare Personnel COVID-19 Vaccination Cumulative Summary to signify the update in the COVID-19 vaccination recommendations.

Crosswalk and Justification for Changes
Type of Change	Changed From	Changed To	Justification	Impact to Burden
Deleted questions 2.1 through 2.99.	2. Cumulative number of HCP in Question #1 who have received COVID-19 vaccine(s) at this facility or elsewhere since December 2020: 2.1. *Only dose 1 of Pfizer-BioNTech COVID-19 vaccine 2.2. *Dose 1 and dose 2 of Pfizer-BioNTech COVID-19 vaccine 2.3. *Only dose 1 of Moderna primary COVID-19 vaccine 2.4. *Dose 1 and dose 2 of Moderna COVID-19 vaccine 2.5. *Dose of Janssen COVID-19 vaccine 2.99. Complete COVID-19 vaccination series: unspecified manufacturer * Any completed COVID-19 vaccine series	Question 2 on the current data collection form currently reads: "Cumulative number of HCP in Question #1 who are up to date with COVID-19 vaccines.”	Currently, CDC is only collecting data on up to date COVID-19 vaccination status. Therefore, data on primary series vaccination are no longer needed.	Decreased burden due to reduction of questions.
Deleted question 4	4. *Cumulative number of HCP in question #2 eligible to receive an additional dose or booster of COVID-19 vaccine	N/A	Currently, CDC is only collecting data on up to date COVID-19 vaccination status. Therefore, data on additional and booster doses are no longer needed.	Decreased burden due to reduction of questions.
Deleted question 5	5. *Cumulative number of HCP in question #4 who have received an additional dose or booster of COVID-19 vaccine at this facility or elsewhere since August 2021	N/A	Currently, CDC is only collecting data on up to date COVID-19 vaccination status. Therefore, data on additional and booster doses are no longer needed.	Decreased burden due to reduction of questions.
Deleted questions 5.1 through 5.4	5.1. *Additional dose or booster of Pfizer-BioNTech COVID-19 vaccine 5.2. * Additional dose or booster of Moderna COVID-19 vaccine 5.3 * Additional dose or booster of Janssen COVID-19 vaccine 5.4. Additional dose or booster of unspecified manufacturer * Any Additional dose or booster of COVID-19 vaccine series	N/A	Currently, CDC is only collecting data on up to date COVID-19 vaccination status. Therefore, data on additional and booster doses are no longer needed.	Decreased burden due to reduction of questions.
Deleted questions 6.1 through 6.4	6.1 Is your facility enrolled as a COVID-19 vaccination provider? [Select Yes or No] 6.2. Did your facility have a sufficient supply of COVID-19 vaccine(s) to offer all HCP the opportunity to receive COVID-19 vaccine(s) from your facility in the current reporting week? [Select Yes or No] 6.3. Did your facility have other arrangements sufficient to offer all HCP the opportunity to receive COVID-19 vaccine(s) in the current reporting week (examples of other arrangements include referring to the health department or pharmacies for vaccination)? [Select Yes or No] 6.4. Please describe any other COVID-19 vaccination supply-related issue(s) at your facility. [Optional]	N/A	Collecting vaccine supply data through NHSN is no longer needed.	Decreased burden due to reduction of questions.

Justification:

Revisions the data collection form will ensure that CDC NHSN is collecting the appropriate information regarding the current recommendations for COVID-19 vaccination.

Time Burden:

Estimated 45 minutes to complete the data collection. The Avg. Burden per Response decreased by 45 minutes. The Number of Respondents increased from 12,600 to 32,900. Number of Responses per Respondent increased from 52 to 76. Total Burden hours increased from 982,800 to 1,875,300.

Burden Estimates – 0920-1317

As a result of proposed changes to the forms, the estimated annualized burden is expected to increase by 766,942 hours, from 5,693,130 to 6,460,072.

Form 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
57.218 Weekly Respiratory Pathogen and Vaccination Summary for Residents of Long-Term Care Facilities (CSV file)	16,500	52	25/60	357,500	$47.53	$16,991,975	Microbiologist
57.219 Healthcare Personnel COVID-19 Vaccination Cumulative Summary (CSV)	32,900	76	45/60	1,875,300	$47.53	$89,133,009	Microbiologist
Total Burden Hours for 0920-1317 6,460,072