Explanation for Program Changes [0920-1443]

Explanation for Program Changes or Adjustments

There are two 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.

CDC is requesting non-substantive changes to the CDC Initial Screening and POE Public Health Risk Assessment forms. The purpose of this change is to streamline the data collection by providing clarifying language and reordering the questions to streamline the forms for both travelers and CDC staff conducting these screenings.

Details of each collection instrument are as follows:

ABCs:

This non-substantive change request includes minor proposed changes to 2 approved data collection tools (form/s) detailed below: 

Approved Forms: 

1. CDC Initial Screening

2. POE Public Health Risk Assessment

CDC Initial Screening Form
Type of Change	Itemized Changes / Justification	Impact to Burden
Revision	Vomiting or diarrhea? Justification: Removed comma for grammatical correctness	No change to burden
Revision	Were you present in any healthcare facility in Rwanda? Justification: Added ‘Rwanda’ to provide clarity for traveler.	No change to burden
Revision	Did you have any contact with or were you near a sick person? Justification: Formatted as a question for consistency with the rest of the section.	No change to burden
Revision	Did you come into contact with anyone's blood or other body fluids?   Justification: Revised language for consistency with the rest of the section.	No change to burden
Revision	What was the main reason you were in Rwanda? (mark all that apply)  ☐ Other Humanitarian Service (not healthcare or public health) Justification: Revised response option to spell out abbreviation	No change to burden
Addition	Duration of stay at U.S. destination: _______days (if ≥21, enter 21)   Justification: Added question to align with CDC’s Interim Recommendations for Public Health Management of U.S.-based Healthcare Personnel Returning from Rwanda.	No change to burden
Addition	☐ Self-monitoring   Justification: Added option for CDC staff to indicate recommended public health intervention	No change to burden
POE Public Health Risk Assessment
Type of Change	Itemized Change / Justification	Impact to Burden
Revision	Reason for Referral: ☐ Provided healthcare/interactions with patients (e.g., professional, trainee, student) Justification: Reworded and moved option up to align with likely exposures	No change to burden
Revision/Deletion	Tell traveler: You were referred for this additional public health assessment because we need to get more information to complete a public health evaluation. Justification: Reworded so process is clearer to traveler.	No change to burden
Addition	HEALTH ASSESSMENT ☐ No symptoms reported Justification: Added option to indicate if traveler does not report symptoms	No change to burden
Revision	Use of antipyretic medication(s) in past 4824 hours2 days Justification: Changed 48 hours to 2 days is easier for traveler to understand.	No change to burden
Revision	Complete this section if provided healthcare/interacted with patients Justification: Updated language to align with CDC’s Interim Recommendations for Public Health Management of U.S.-based Healthcare Personnel Returning from Rwanda.	No change to burden
Addition	Comments: _________________________________________________ Justification: Added field to capture qualitative information reported by traveler	No change to burden
Revision	Complete this section if any presence in healthcare facility (HCF)/healthcare setting Justification: Reworded to make it easier for travelers to understand.	No change to burden
Revision	☐ Clinical Lab Justification: Reworded to make it easier for travelers to understand.	No change to burden
Revision	Last day present in HCF (mm/dd/yy): ____ /____/_____ Justification: Changed order of question so questions related to presence in Rwandan healthcare facility are grouped together	No change to burden
Addition	Does the traveler work in a U.S. healthcare facility? ☐ Yes ☐ No Justification: Updated language to align with CDC’s Interim Recommendations for Public Health Management of U.S.-based Healthcare Personnel Returning from Rwanda.	No change to burden
Revision	Complete this section if provided healthcare, contact/near a sick person, contact with blood/body fluids Justification: Revised language from ‘exposure assessment’ which is jargon, to plain language.	No change to burden
Revision	Did you have any contact with blood/body fluids? ☐ YES ☐ NO If NO, skip to sick person question Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Addition	Did this contact involve any of the following? Check as applicable: ☐ Needlestick ☐ Other injury with a sharp object (that is, piercing of your skin) ☐ Skin contact ☐ Splash to the eye, nose, or mouth Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Addition	Was the person suspected or known to have Marburg? ☐ YES SUSPECTED ☐ YES CONFIRMED ☐ UNSURE ☐ NO Diagnosis other than Marburg, if known:_____________________________________________ Description: ______________________________________________________ Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Did you have contact with any sick person? ☐ YES ☐ UNSURE ☐ NO If NO, section is complete. Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Addition	Did the person have fever? ☐ YES ☐ UNSURE ☐ NO Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Did the sick person have vomiting, diarrhea, or bleeding? ☐ YES ☐ UNSURE ☐ NO Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Was the person suspected or known to have Marburg? ☐ YES SUSPECTED ☐ YES CONFIRMED ☐ UNSURE ☐ NO Diagnosis other than Marburg, if known: ____________________________________________ Justification: Necessary to determine if traveler is high-risk and if immediate intervention is required.	No change to burden
Revision	Did you have physical contact with this person? ☐ YES ☐ NO Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Did you stay in the same household as this person? ☐ YES ☐ NO Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Did you provide care to this person? ☐ YES ☐ NO If YES to provided care: Did you provide this care in a healthcare facility or another location? ☐ HCF ☐ Home ☐ Other: ___________________________________ Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	For healthcare personnel only: What personal protective equipment did you use? (Most relevant for care given to a patient with known or suspected MVD) ☐ No PPE/A ☐ Surgical or medical mask ☐ N95 Respirator (e.g., N95, KN95) ☐ Surgical hood ☐ PAPR ☐ Disposable fluid-resistant or impermeable gown/coverall ☐ Disposable apron ☐ Disposable full-face shield or g ☐ Goggles ☐ Disposable facemask ☐ Waterproof rubber boots ☐ Boot covers ☐ One pair of Latex/nitrile gloves: ☐ One pair ☐ Two pairs of disposable gloves (outward gloves with extended cuffs) Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Addition	Did you perform hand hygiene after removing PPE? ☐ YES ☐ NO Justification: Clarified language for travelers and screeners; necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Did you participate in an invasive procedure on the ill person or aerosol-generating procedure? ☐ YES ☐ NO ☐ N/A Justification: Clarified language for travelers and screeners.	No change to burden
Revision	Complete this section if worked in a clinical laboratory Justification: Clarified language for travelers and screeners.	No change to burden
Revision/Addition	What PPE did you use? ☐ None ☐ Surgical or medical mask ☐ Respirator (e.g., N95, KN95) ☐ Surgical hood ☐ PAPR ☐ Disposable fluid-resistant or impermeable gown/coverall ☐ Disposable apron ☐ Disposable full-face shield or g☐ Goggles ☐ Waterproof rubber boots ☐ Disposable facemask ☐ Boot covers ☐ N95 respirator ☐ PAPR ☐ Latex/nitrile gloves: ☐ One pair ☐ Two pairs (outward with extended cuffs) ☐ Other: __________________________________ Justification: Added additional response options. Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Addition	Did you perform hand hygiene after removing PPE? ☐ YES ☐ NO Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Complete if worked as environmental cleaner or doing laundry in HCF Justification: Clarified language for travelers and screeners.	No change to burden
Revision	What was your role in the healthcare facility? Justification: Changed question to open ended and clarified language for travelers and screeners.	No change to burden
Addition	Did you handle wet or soiled laundry? ☐ YES ☐ NO Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision/Addition	What protective equipment PPE did you use? ☐ None ☐ Surgical or medical mask ☐ Respirator (e.g., N95, KN95) ☐ Disposable fluid-resistant or impermeable gown/coverall ☐ Disposable apron ☐ Disposable full-face shield ☐ Goggles ☐ Waterproof rubber boots ☐ Boot covers ☐ Disposable apron ☐ N95 respirator ☐ Disposable gloves ☐ Other: __________________________________ Latex/nitrile gloves: ☐ One pair ☐ Two pairs ☐ Other: ________________________________________________ Justification: Spelled out abbreviations and added additional response options. Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Addition	Did you wash hands after removing protective equipment? ☐ YES (every time) ☐ NO (not every time) Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Complete this section if reported contact with dead body or attended a funeral or burial Justification: Clarified language for travelers and screeners	No change to burden
Addition	Did you attend a funeral or burial? ☐ YES ☐ NO Did you touch a dead body? ☐ YES ☐ NO Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Please describe presence in a funeral or touching a dead body (touched deceased garments, belongings, or water used to wash body?) Justification: Added additional examples to provide clarity for travelers	No change to burden
Addition	Did you serve as mortuary/burial worker? ☐ YES ☐ NO If NO, go to Final Open Question. Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision/Addition	If a mortuary/burial worker, what PPE did you use? ☐ None ☐ Surgical or medical mask ☐ Respirator (e.g., N95, KN95) ☐ Disposable fluid-resistant or impermeable gown/coverall ☐ Disposable apron ☐ Disposable full-face shield ☐ Goggles ☐ Disposable apron ☐ Waterproof rubber boots ☐ Boot covers ☐ N95 respirator ☐ Disposable gloves Latex/nitrile gloves: ☐ One pair ☐ Two pairs (outward with extended cuffs)	No change to burden
Addition	Did you wash hands after removing protective equipment? ☐ YES (every time) ☐ NO (not every time) Justification: Necessary to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden
Revision	Did you have any problems with your PPE that resulted in skin or clothes coming into contact with the dead body or body fluids? ☐ YES ☐ NO ☐ UNSURE Justification: Added additional examples to provide clarity for travelers	No change to burden
Addition	FINAL OPEN QUESTION: (all travelers) Any other situation that is of concern to you about your health that we haven’t raised? Justification: Optional question for travelers to determine if traveler is high-risk and if immediate intervention or travel restrictions are required.	No change to burden