NonSubstantive Change Request Justification

Non-substantive Change Request

OMB Control Number 0920-0666

National Healthcare Safety Network (NHSN) 

Surveillance in Healthcare Facilities 

Date Submitted: 2/24/2025

Summary of request: CDC/National Center for Emerging and Zoonotic Infectious Diseases is requesting a change request to revise questions to align with EO 14168 Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.

Description of Changes Requested: This request updates sex questions used in

National Healthcare Safety Network (NHSN) Surveillance in Healthcare Facilities 

to be in accordance with EO 14168. Please check the boxes below if your request includes:

 Revision of an existing question(s)

 Deletion of an existing question(s)

The below forms in NHSN have been updated to reflect the following:

• Change all labels across the entire application from “Gender” to “Sex”

• Change options for Sex to Male or Female

• Remove option Other for Sex

• Remove all references: “Sex at Birth” and “Gender Identity”

1. 57.108 Primary Bloodstream Infection (BSI)

2. 57.111 Pneumonia (PNEU)

3. 57.112 Ventilator-Associated Event

4. 57.113 Pediatric Ventilator-Associated Event (PedVAE)

5. 57.114 Urinary Tract Infection (UTI)

6. 57.115 Custom Event

7. 57.120 Surgical Site Infection (SSI)

8. 57.121 Denominator for Procedure

9. 57.123 Antimicrobial Use and Resistance (AUR)

10. 57.125 Central Line Insertion Practices Adherence Monitoring

11. 57.126 MDRO or CDI Infection Form

12. 57.128 Laboratory-identified MDRO or CDI Event

13. 57.129 Adult Sepsis

14. FHIR Measures-Patient Safety Component (HOB, HT-CDI, VTE, Adult Sepsis, RPS, NVAP)-Excel spreadsheet

15. FHIR Measure-Neonatal Component-Late Onset Sepsis Meningitis (LOSMEN) Module- Excel spreadsheet

16. FHIR Measures-Medication Safety (HYPO, HAKI, ORAE)- Excel spreadsheet

17. 57.138 Laboratory-identified MDRO or CDI Event for LTCF

18. 57.140 Urinary Tract Infection (UTI) for LTCF

19. 57.145 Long Term Care Antimicrobial Use (LTC-AU) Module- Digital Upload Specification Tables

20. 57.300 Hemovigilance Module Annual Survey

21. 57.306 Hemovigilance Module Annual Survey - Non-acute care facility

22. 57.307 Hemovigilance Adverse Reaction - Acute Hemolytic Transfusion Reaction

23. 57.308 Hemovigilance Adverse Reaction - Allergic Transfusion Reaction

24. 57.309 Hemovigilance Adverse Reaction - Delayed Hemolytic Transfusion Reaction

25. 57.310 Hemovigilance Adverse Reaction - Delayed Serologic Transfusion Reaction

26. 57.311 Hemovigilance Adverse Reaction - Febrile Non-hemolytic Transfusion Reaction

27. 57.312 Hemovigilance Adverse Reaction - Hypotensive Transfusion Reaction

28. 57.313 Hemovigilance Adverse Reaction – Infection

29. 57.314 Hemovigilance Adverse Reaction - Post Transfusion Purpura

30. 57.315 Hemovigilance Adverse Reaction - Transfusion Associated Dyspnea

31. 57.316 Hemovigilance Adverse Reaction - Transfusion Associated Graft vs. Host Disease

32. 57.317 Hemovigilance Adverse Reaction - Transfusion Related Acute Lung Injury

33. 57.318 Hemovigilance Adverse Reaction - Transfusion Associated Circulatory Overload

34. 57.319 Hemovigilance Adverse Reaction - Unknown Transfusion Reaction

35. 57.320 Hemovigilance Adverse Reaction - Other Transfusion Reaction

36. 57.402 Outpatient Procedure Component Same Day Outcome Measures

37. 57.404 Outpatient Procedure Component - SSI Denominator

38. 57.405 Outpatient Procedure Component - Surgical Site (SSI) Event

39. 57.502 Dialysis Event

40. 57.601 Late Onset Sepsis/ Meningitis Denominator Form: Late Onset Sepsis/ Meningitis Denominator Form: Data Table for monthly electronic upload

41. 57.602 Late Onset Sepsis/ Meningitis Event Form: Data Table for Monthly Electronic Upload

42. Billing Code Data: 837I Upload 

If revising an existing question, CDC is advised to use one of the two versions below and can state that CDC will be changing the current Gender/Sex question to:

What is your Sex?

- Male

- Female

OR

What is your Sex?

- Male

- Female

- Undetermined

- Missing Value [Null]

Description of Changes to Burden (if applicable): There is no change in Burden Hours associated with the modifications made to comply with EO 14168.

Description of Changes to Burden (if applicable): Form	Approved Burden	Requested Burden
N/A	N/A	N/A
N/A	N/A	N/A
Total	TOTAL TIME	TOTAL TIME

** If changes are only made to Gender/Sex question these are expected to result in no change in Burden Hours. Program can state: “There is no change in Burden Hours associated with the modifications made to comply with EO 14168” **

Other Considerations (optional): CDC can include other aspects associated with the submission of this Non-Substantive Change Request here (e.g., timing sensitivities, implementation requirements, etc.,).

The Medication Safety Annual Hospital Survey collects facility-level data from the previous calendar year and is completed by all facilities enrolled in the Medication Safety Component. The data will be used in analysis of data collected within the modules included in the Medication Safety Component, as well as used to support decision making, program planning, and research across CDC. Annual survey data will be collected electronically once annually via the NHSN application.

The goal of the NHSN Medication Safety Component is to enable collection of inpatient metrics to improve patient safety, facilitate hospital quality improvement efforts, and inform national benchmarking. The Medication Safety Component has expanded to include additional measures that will help accomplish this goal, including Hyperglycemia (HYPER). These new measures are all important hospital medication safety or hospital adverse events that impact patients and should be under national surveillance. The expansion of the Medication Safety Component requires a name change of the previous Glycemic Control Annual Hospital Survey to reflect an addition of annual survey questions applicable to current and future measures included in the Medication Safety Component. Existing questions related to Glycemic Control are revised to include reference to facility-level information related to Hyperglycemia practices and policies, in addition to Hypoglycemia. These revisions ensure improved relevance, enhanced data quality, alignment with industry standards and regulations, increased efficiency, and expanded analysis capabilities within the CDC.

The questions that are being deleted are check box questions that do not take a significant amount of time to complete, typically a minute or so. Therefore, no burden updates are being made due to these revisions.

Table A: Description of Changes (optional, helpful if multiple changes to multiple forms):	Type of Change	Question/Item	Requested Change
57.701 Glycemic Control Module-HYPO Annual Survey	Name change	Change from 57.701 Glycemic Control Module-HYPO Annual Survey  To Medication Safety Component-Annual Hospital Survey
	Revision	Change from 6.*Select the module(s) for which your facility currently reports or intends to report data: □ Glycemic Control Module □ Opioid-Related Adverse Events (ORAE) Module To 6.*Select the module(s) for which your facility currently reports or intends to report data: □ Glycemic Control Module	Removal of the ORAE module selection in the NHSN Medication Safety Component
	Deletion	Section 3a. Opioid Prescribing Safety Practices 13.*Does your facility have an inpatient opioid stewardship quality improvement program? (Check one.) Yes No Other; please describe: 14.*Does your facility have any of the following practices in place within or outside of an opioid stewardship program: (Check all that apply.) Leadership Commitment such as a senior executive who serves as a point of contact or “champion” to help ensure the opioid stewardship practices has resources and support to accomplish its mission. Maintain written policies and procedure that support opioid stewardship activities. Support clinical knowledge, expertise, and practice such as require ongoing clinician training, education, and engagement to support effective pain management and opioid stewardship for prescribers and care teams. Patient and Family Caregiver Education and Engagement, such as patient/family education related to pain management goals and modalities. Tracking, Monitoring, and Reporting of key quality metrics are used to identify opportunities for improvement and to assess the impact of opioid stewardship efforts. Accountability, such as set measurable goals for promoting, establishing, and maintaining a culture of opioid stewardship. Community Collaboration and coordination with community leaders and stakeholders Our facility does not have an opioid stewardship quality improvement or safety program in place. Our facility has other opioid safety practices, please describe briefly: __________________ Section 4b. Education 15.*Does your facility have opioid prescribing education programs or practices in place? (Check one.) Yes No [If checked, skip questions 15a and 15b] Other; please describe: _______________ [If checked, skip questions 15a and 15b] 15a. If your facility has opioid prescribing education programs or practices in place, how frequently is education provided? (Check all that apply.) At time of hire/orientation At least annually At least quarterly Other; please describe: __________________ 15b. If your facility has opioid prescribing education programs or practices in place, what groups of healthcare workers are included in your opioid education programs or practices? (Check all that apply.) Physicians and licensed independent practitioners authorized to prescribe in your state (e.g., physician assistants, nurse practitioners) Nursing staff Pharmacy staff Other staff; please describe: __________________ Section 4c. Quality Measurement 16.*What quality metrics are tracked, monitored and/or reported related to opioid safety or quality improvement? (Check all that apply.) Opioid prescribing trends(e.g., provider, unit, patient-level Use of multi-modal pain management tools Opioid-related adverse events Our facility does not track, monitor, or report opioid quality metrics. [If checked, skip 16a – 16c] Our facility monitors other opioid quality/safety metrics, please describe briefly: ____________ 16a. If opioid quality/safety metrics are tracked, monitored, and/or reported, at what level is data trended and/or reported? (Check one.) Physician-level Specialty-level Unit-level Facility-Level Other level; please describe: ____________ 16b. What type of opioid-related adverse events are tracked in your facility? (Check all that apply.) Allergic adverse events (e.g., anaphylaxis) Other adverse drug events (e.g., constipation) confusion, delirium, respiratory depression) Events requiring administration of an opioid antagonist Events that result in a transfer to a higher level of care Events that result in patient death Our facility does not track, monitor, or report opioid-related adverse events Our facility monitors other opioid-related adverse events, please describe briefly: ____________ 16c. If opioid-related events are tracked, what methods are used to identify potential opioid-related adverse events? (Check all that apply.) Voluntary reporting system Alerts for antagonist medication administration (e.g., naloxone administration) Code Blue/Medical Emergency Team activations Reports to quality/safety leadership Other methods, please describe briefly: _______________	These questions are no longer required for this release and will be reintroduced in the survey at a future date; data collection is consolidated and streamlined.