Explanation for Program Changes or Adjustments_23MAY2025

Explanation for Program Changes or Adjustments

There are 8 total forms being changed as a part of this non substantive change request. This change request includes minor revised language, formatting and rewording to improve clarity and readability of the data collection forms.

Details of each collection instrument are as follows:

FoodNet

This non-substantive change request includes minor proposed changes to 1 approved data collection tools (form/s) detailed below: 

Approved Forms: 

1. FN200.1-FN200.8 (FoodNet Active Surveillance Data Elements List) 

FoodNet Active Surveillance Data Elements List
Type of Change	Itemized Changes / Justification	Impact to Burden
Value set change for variable AgSphlTestType	The value of “Meridian ImmunoCard STAT! E. coli O157 Plus” was added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable DXO157TestType	The values of “Abbott Shiga Toxin Quik Chek”, “Meridian ImmunoCard STAT! EHEC”, “Meridian Premier EHEC”, “Metametrix” were removed; the values of “BioCode Gastrointestinal Pathogen Panel (GPP)”, “Great Basin Scientific Stool”, “Medical Diagnostics” were added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable PcrClinicTestType	The value of “QIAstat-DX Gastrointestinal Panel 2” was added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable PcrSphlTestType	The value of “QIAstat-DX Gastrointestinal Panel 2” was added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable SeroSite	The values of Campylobacter (jejuni; jejuni subsp jejuni; jejuni subsp. doylei; coli; ,lari; lari subsp. concheus; lari subsp. lari; upsaliensis; helveticus; fetus; fetus subsp fetus; fetus subsp venerealis; hyointestinalis; hyointestinalis subsp. hyointestinalis; hyointestinalis subsp. lawsonii; sputorum; sputorum bv sputorum; sputorum bv paraureolyticus; lanienae; mucosalis; insulaenigrae; concisus; curvus; rectus; showae; gracilis; canadenesis; peloridis; avium; cuniculorum; hominis; ureolyticus; Unknown) were added, as the SpeciesClinic and SpeciesSphl variables were removed when data collection for CIDT-positive Campylobacter cases was discontinued. The variable SeroSite is now used to capture serotype information for Campylobacter.	No impact to burden.
Value set change for variable SiteID	The value of “COEX” was added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable StecHAg	The value of “999 = non-motile” was added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable StecOAg	The value of “666=not O157, O antigen unknown” was removed to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Value set change for variable CSTE	The values of “Yes, confirmed” and “Yes, probable” were removed, and the value of “Yes” was added to assist data collectors in capturing data in a standardized fashion to improve accuracy.	No impact to burden.
Added the following variables: CEA_clinical_intv CEA_intv CEA_travel_intv NarmsLink_Other RUCC SalGroupLetter SalGroupNumber TravelDest_Clean Typh_Salm	These variables are derived by CDC FoodNet from data submitted by FoodNet sites. They were added to assist in summarizing data.	No impact to burden.
Removed the following variables: CDCID NSTID OtherCDCTestType SpeciesCdc	These variables are derived by CDC FoodNet from data submitted by FoodNet sites. They are no longer derived and have been removed from the variable list.	No impact to burden.

HAIC

This non-substantive change request includes minor proposed changes to 8 approved data collection tools (form/s) detailed below: 

Approved Forms: 

1. HAIC.400.1–Multi-Site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form 

2. HAIC.400.3–HAIC MuGSI Supplemental Surveillance Officer Survey

3. HAIC.400.4–Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report - 2025 

4. HAIC.400.6–2024 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey 

5. HAIC.400.7 - CDI Case Report and Treatment Form   

6. HAIC.400.8 - Annual Survey of Laboratory Testing Practices for C. difficile Infections 

7. HAIC.400.9 - HAIC- CDI Annual Surveillance Officers Survey  

 

 

HAIC.400.1 – HAIC- 2026 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Case Report Form
Type of Change	Itemized Change / Justification	Impact to Burden
Administrative	2026 Multi-site Gram-Negative Surveillance Initiative (MuGSI) Healthcare-Associated Infections Community Interface (HAIC) Case Report From Changes: Updated year to 2026 Justification: Updated to reflect the surveillance year	None
Administrative/Addition of Response Option	Question 17a: Types of Infections Associated with Culture(s) Changes: Added option for “Biliary tract infection” Justification: The inconsistent nature of data collected in free-text fields make analysis challenging. The additional option offered on the form was derived from analyzing previous free-text responses, aiming to standardize and streamline data collection.	None
HAIC.400.3 – HAIC MuGSI Supplemental Surveillance Officer Survey
Type of Change	Itemized Change / Justification	Impact to Burden
Administrative	2025 HAIC Multi-site Gram-negative Surveillance Initiative (MuGSI) Supplemental Surveillance Officer Survey Changes: Updated year to 2025 Justification: Updated to reflect the correct years in question	None
Administrative	Please answer the following questions for the year 2025, unless otherwise specified. The purpose of the survey is to verify and document current surveillance procedures, including isolate collection and testing methods at clinical laboratories. Please enter your responses into the corresponding REDCap database. If you have questions, please contact Joshua Brandenburg (ode4@cdc.gov) and the MuGSI Inbox (mugsi@cdc.gov). Changes: Update year to 2025 Removed staff whom left; replaced with a functional email inbox Justification: Previous contact no longer supports the program	None
Administrative	Question 2: Did any laboratories drop out of participation in 2024? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 3: In 2024, did you identify additional laboratories, regardless of location, which identify MuGSI isolates from persons who are residents of the MuGSI surveillance area at your site? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 4: Did your site send any MuGSI isolates to CDC for characterization in calendar year 2024? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 5: How many isolates with a specimen collection date in 2024 did you expect to be able to collect from the clinical laboratories? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 6: What was the total number of isolates with a specimen collection date in 2024 that were collected from the clinical laboratories? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Laboratory Participation and Isolate Testing – Part 2 Please complete the following information for each clinical laboratory participating in MuGSI surveillance at your site in 2024 Changes: Updated the year from 2023 to 2024 for the section’s instructions Justification: Specifying the timeframe relative to the instructions for the section.	None
Administrative	Question 2: In 2024, did your site update its inventory of facilities within the MuGSI surveillance area? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 4: Did your site geocode MuGSI cases in 2024? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 5. Did your site match MuGSI cases to the state vital statistics death registry in 2024? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
Administrative	Question 6: Did your site complete CRF re-abstractions in 2024? Changes: Updated the year from 2023 to 2024 Justification: Specifying the timeframe relative to the question	None
HAIC.400.4 Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface Case Report – 2026
Type of Change	Itemized Change / Justification		Impact to Burden
Administrative	Invasive Staphylococcus aureus Healthcare-Associated Infections Community Interface (HAIC) Case Report – 2026 Changes: Updated year to 2026 Justification: Updated to reflect the surveillance year		None
Revision	Question 28a. Does the patient have: Non-dialysis prosthetic vascular graft? □ Yes □ No □ Unknown Changes: Added the word “prosthetic” Justification: The addition of the word prosthetic indicates that we only want information on this subset of vascular grafts		None
HAIC.400.6–2024 HAIC Invasive Staphylococcus aureus Supplemental Surveillance Officer Survey
Type of Change	Itemized Change / Justification		Impact to Burden
Administrative	HAIC Invasive Staphylococcus aureus Surveillance Officer Survey Changes: Removed year from title Justification: Allows the survey to be used across multiple years		None
Administrative	Added “Surveillance year: _______” Changes: Surveillance year: _____ Justification: Allows the survey to be used across multiple years		None
Administrative	Please answer the following questions for the surveillance year. The purpose of the survey is to verify and document current surveillance procedures, including cases ascertainment and auditing methods. Changes: Updated “2024” to “surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Did your site send MRSA/MSSA isolates to CDC for characterization in the surveillance year?  ___yes  ____no  Changes: Updated “in 2024” to “in the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Lab Participation and Case Finding  Please answer the following questions for hospitals and labs under surveillance during the surveillance year.  Changes: Updated “for 2024” to “during the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Indicate the percentage contribution of each case finding method to your site’s total SA case counts (100%) during the surveillance year. Changes: Updated “in 2024” to “during the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Do you expect this distribution and/or percentage values to change next surveillance year?   Changes: Updated "in 2025” to “next surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Did any labs drop out of participation in the surveillance year?  Changes: Updated ”2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	In the surveillance year, did you identify any additional labs, regardless of location, which identify invasive SA isolates from persons who are residents of your catchment area?  Changes: Updated "2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Did your site complete CRF re-abstractions during the surveillance year?   Changes: Updated "2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	How did your site define an audit case during the surveillance year?  Changes: Updated "in 2024” to “during the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Indicate the percentage contribution of each case finding method to your site’s audit counts (100%) during the surveillance year.  Changes: Updated "in 2024” to “during the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	How many laboratories did you audit in the surveillance year?  Changes: Updated "2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	In the surveillance year, did your site update its inventory of facilities within the EIP catchment area? Changes: Updated "2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Did your site geocode SA cases in the surveillance year?  Changes: Updated "2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	Did your site link SA cases to vital records (mortality matching) in the surveillance year?  Changes: Updated "2024” to “the surveillance year” Justification: Allows the survey to be used across multiple years		None
Administrative	CDC staff are responsive to questions/concerns/emails (e.g., Holly Biggs, Davina Campbell, Kelly Jackson, and Isaac See) Changes: Removed one staff member Justification: Staff member no longer with the program		None
HAIC.400.7 - HAIC 400.7 HAIC – CDI Case Report Treatment Form
Type of Change	Itemized Change / Justification		Impact to Burden
Administrative	Change: Updated year to 2026 Justification: Updated to reflect the appropriate year of data collection		None
HAIC.400.8 - Annual Survey of Laboratory Testing Practices for C. difficile Infections
Type of Change	Itemized Change / Justification		Impact to Burden
Administrative	Questions: Was this a new laboratory in 2025?     How often did you receive line lists from this lab in 2025?   How did you receive line lists from this lab in 2025?   Did you receive specimens from this lab in 2025?   Was this lab audited in 2025?   Types of facilities in your catchment area served by this lab in 2025 Did your laboratory ever send specimens off-site for Clostridioides difficile testing in 2025?  Questions 2a, 3a, 3b, 4b, 5a, 5b, 6, 7, 7a, 8 Change: Updated year to 2025 Justification: Updated to reflect the appropriate year of data collection		None
HAIC.400.9 - HAIC- CDI Annual Surveillance Officers Survey
Type of Change	Itemized Change / Justification		Impact to Burden
Administrative	Questions 2, 3, 10, 13 Change: Updated year to 2025 Justification: Updated to reflect the appropriate year of data collection		None