Change Request Memo 06OCT2020

Non-Substantive Change Request to OMB Control Number 0920-1296

Contact

Nora Chea, MD, MSc

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Road, NE

Atlanta, Georgia 30333

Phone: (404)-639-0025

Email: [email protected]

Submission Date: 09/18/2020

CDC requests approval for a non-substantive change to OMB Control No. 0920-1296: Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel.

Protocol Name: Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version August 17, 2020

Justification for changes:

Based on feedback from Emerging Infection Program (EIP) sites about variability of participating healthcare facilities in reporting healthcare personnel (HCP) or COVID-19 patient/resident denominator data, we propose to modify the protocol and the “Denominator form” to provide additional flexibility. The proposed modifications include additional options for reporting denominator data and allow EIP sites and facilities to report facility-specific denominator data (e.g., a subset of the requested denominator data or data for a specific year or period of months) or data that have already been or will be submitted to the CDC’s National Healthcare Safety Network (NHSN) (e.g., influenza HCP vaccination summary of the HCP Vaccination Module).

We also propose minor edits to the introductory scripts for HCP phone interview in Appendix 3 and the sample email texts in Appendix 4.

Form Name: Denominator form

Justification for changes:

1. We propose to add two tables (Table A and Table E) in the “Denominator form” to provide additional flexibility and options for reporting denominator data. Facilities have specific ways in which total numbers of HCP employees, non-employees, and patients or residents are tracked, and data are not available in the same format from all facilities.

• Table A is for reporting the number of HCP who worked in the facility for at least one day from October 1, 2019 through March 31, 2020 or from October 1, 2020 through March 31, 2021 when applicable. Since many facilities have already reported this number to the CDC’s NHSN (or will report in the coming months for the 2020-2021 influenza season), EIP sites can access these data through state health department or obtain them directly from the facilities.

• Table E is similar to Table D, but EIP sites may customize the report dates and HCP category grouping according to data available at each participating facility.

Addition of these two tables will allow EIP sites to report data they already have and/or reduce burden on the participating facilities to generate new data for this project, which in some cases is not feasible within the suggested timeframe.

2. We also propose removing data on the number of COVID-19 patients/residents in the participating facilities from Table A (of the currently approved form) and creating a separate Table B (in the proposed modified form) for these data. Table B in the modified form includes an additional field for the number of COVID-19 patient-days. Based on feedback from EIP sites, some facilities will not be able to report the total number of individual COVID-19 patients/residents per month, but will be able to report the number of COVID-19 patients-days per month. The number of COVID-19 patient-days can be used as an alternative denominator when assessing the relationship between the incidence of COVID-19 among HCP and the presence of COVID-19 patients or residents in the facility during the month.

Burden:

Because the changes to the form and protocol are minimal, the estimates of annualized burden hours for this change request will stay the same.

The burden estimate for the “Denominator form” included in OMB Control No. 0920-1296 is 100 hours.

	Form Name	No. of Respondents	No. of responses per respondent	Avg. burden per response (hours)	Total burden (hours)
Approved	Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2: Denominator Form	50	6	20/60	100
Requested	Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2: Denominator Form	50	6	20/60	100

Description of Changes:

The changes to the protocol are as follows:

1. Update “Data Collection” section to allow EIP sites and facilities to report facility-specific denominator data (e.g., a subset of the requested denominator data or data for a specific year or period of months) or data that have already been or will be submitted to the CDC’s National Healthcare Safety Network (NHSN) (e.g., influenza HCP vaccination summary of the HCP Vaccination Module).

2. Edit the introductory scripts and sample email texts for HCP.

Protocol	Current wording	Requested Change
Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version September 17, 2020	Data collection The proposed paragraph did not exist	Data collection Propose to add this paragraph in the protocol Healthcare facilities may vary in their ability to provide the HCP or COVID-19 patient/resident denominator data specified above. Facility-specific approaches to reporting denominator data, other than those noted above, may be developed in collaboration with EIP sites. For example, some facilities may only be able to report a subset of the requested denominator information and/or may only be able to report data for a specific year or period of months. Facilities that participate in the CDC National Healthcare Safety Network (NHSN) Healthcare Personnel Influenza Vaccination summary reporting (https://www.cdc.gov/nhsn/faqs/vaccination/faq-influenza-vaccination-summary-reporting.html) may be able to deliver HCP denominator data for the 2019–2020 influenza season (covering the period from October 1, 2019 through March 31, 2020). This is an acceptable option for facilities unable to provide current denominator data.
Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version September 17, 2020	Introductory script for telephone interview of HCP cases You have been identified as a healthcare worker who has developed COVID-19.	Introductory script for telephone interview of HCP cases You have been identified as a healthcare worker who tested positive for COVID-19.
Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version September 17, 2020	Introductory script for telephone interview of HCP non-cases You have been identified as a healthcare worker who was exposed to COVID-19 in a healthcare facility.	Introductory script for telephone interview of HCP cases You have been identified as a healthcare worker who was tested for COVID-19.
Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version September 17, 2020	Sample email text for HCP cases You have been identified as a [State] healthcare worker who developed COVID-19	Sample email text for HCP cases You have been identified as a [State] healthcare worker who tested positive for COVID-19.
Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, version September 17, 2020	Sample email text for HCP non-cases You have been identified as a [State] healthcare worker who has cared for or been exposed to a patient with COVID-19 in the workplace.	Sample email text for HCP non-cases You have been identified as a [State] healthcare worker who was tested for COVID-19.

The changes to the form are as follows:

1. Addition of Table A for EIP sites to report the number of HCP who worked in the facility for at least one day from October 1, 2019 through March 31, 2020 or from October 1, 2020 through March 31, 2021 when applicable.

2. Addition of Table E for EIP sites to customize the report dates and healthcare personnel category grouping according to data available at each participating facility.

3. Separating the question about number of COVID-19 patients/residents in the participating facilities from Table A (of the currently approved form) and creating Table B (in the proposed modified form) for the question. In addition to the question about the number of COVID-19 patients/residents, we also added a question about the number of COVID-19 patient-days in Table B.

4. Reformat Table C after removing the question about the number of COVID-19 patients/residents.

Refer to Attachment #2 and Attachment #3 for the currently approved denominator form and proposed modified denominator form respectively for detailed changes.

Attachments

Attachment #1: Emerging Infections Program Tracking of SARS-CoV-2 Infections among Healthcare Personnel, Protocol Version September 17, 2020

Attachment #2: Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2: Denominator Form (currently approved version)

Attachment #3: Assessment of Healthcare Personnel Exposed to or Infected with SARS-CoV-2: Denominator Form (Proposed modified version)