National Healthcare Safety Network (NHSN) Patient Impact Module for Coronavirus (COVID-19) Surveillance in Healthcare Facilities

Forms and Documents

Document Name	Status
Form 0920-20LW COVID-19 Patient Impact Module Form Form	New
Att4c_How to Enter and Access COVID Summary Data.docx Supplementary Document	2020-03-24
Revised Emergency Request Memo 23MAR2020.docx Supplementary Document	2020-03-23
Att6_NHSN Report of End of Human Research Review.docx Supplementary Document	2020-03-23
Att5_Closure of CDC Protocol 4062.docx Supplementary Document	2020-03-23
Att1c_42 USC 242m.pdf Supplementary Document	2020-03-23
Att1b_42 USC 242k.pdf Supplementary Document	2020-03-23
Att1a_42 USC 242b.pdf Supplementary Document	2020-03-23
Att3_PIA.pdf Supplementary Document	2020-03-23
Supporting Statement B NHSN COVID-19_clean.docx Supporting Statement B	2020-03-24
Supporting Statement A NHSN COVID-19_clean.docx Supporting Statement A	2020-03-25

IC Document Collections

IC ID	Document Title	Status
240833	COVID-19 Patient Impact Module Form Form	New

ICR Details

OMB Control No: 0920-1290	ICR Reference No: 202003-0920-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20LW
Title: National Healthcare Safety Network (NHSN) Patient Impact Module for Coronavirus (COVID-19) Surveillance in Healthcare Facilities
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 03/24/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 03/26/2020
	Date Received in OIRA: 03/24/2020
Terms of Clearance: Approved consistent with CDC’s commitment to clearly caveat the interpretation of the national representativeness of the data and the ability of this collection to document longitudinal trends due to changes in the number and characteristics of participating hospitals throughout the epidemic as well as differences in how each hospital implements this data collection, including variation in which staff collect the data on any given day.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	6 Months From Approved
Responses	702,000	0	0
Time Burden (Hours)	234,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this information collection is to 1) capture the daily, aggregate impact of COVID-19 on healthcare facilities, and 2) monitor medical capacity to respond at local, state, and national levels. This information will be used to inform the overall real-time COVID-19 response efforts and possible resource allocation, and enable state and local health departments to gain immediate access to the COVID-19 data for hospitals within their jurisdiction.

Emergency Justfication: I have determined that the information must be collected prior to the expiration of time period established under Part 1320, and that this information is essential to CDC’s ability, as well as that of state and local health departments, to effectively address the national public health crisis caused by the Novel Coronavirus (COVID-19). As rates of infection and resulting deaths continue to rise across the nation, healthcare facilities and public health departments are facing significant strain on patient care and infection prevention efforts. NHSN plans to introduce a new surveillance module that will enable hospitals to report daily COVID-19 patient counts to NHSN, and NHSN in turn will enable state and local health departments to gain immediate access to the COVID-19 data for hospitals in their jurisdiction. COVID-19 data submitted to NHSN also will be used immediately by CDC’s emergency COVID-19 response. NHSN’s role as a shared platform for healthcare-associated infection surveillance provides a valuable foundation for COVID-19 surveillance. The COVID-19 modules can additionally be adapted for future outbreaks of COVID or other infectious diseases. A large majority of the nation’s hospitals already participate in NHSN, and infection preventionists (IPs) in those hospitals use NHSN for surveillance and reporting of healthcare-associated infection and antimicrobial resistance. CDC cannot reasonably comply with the normal clearance procedures due to the public harm that could escalate if routine processing of this request is required. CDC requests authorization to use information collection instruments in the existing NHSN web-based application for 180 days to enable immediate CDC and public health departments with immediate access to COVID-19 patient impact data.

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Authorizing Statute(s): US Code: 42 USC 242b, 242k, 242m Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
COVID-19 Patient Impact Module Form	0920-20LW	COVID-19 Patient Impact Module Form

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	702,000	0	0	702,000	0	0
Annual Time Burden (Hours)	234,000	0	0	234,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a New Emergency Collection.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Yes

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 03/24/2020

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