National Healthcare Safety Network (NHSN) Data Validation Study for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) (CMS-10639)

Forms and Documents

Document Name	Status
Form CMS-10639 National Healthcare Safety Network (NHSN) Data Validation Study for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) Form and Instruction	Modified
CMS-10639 Supporting Statement A NHSN CY 2020 (11-15-2019).docx Supporting Statement A	2019-12-23
CMS-10639 Supporting Statement B NHSN CY 2020 (11-15-2019).docx Supporting Statement B	2019-12-23

IC Document Collections

IC ID	Document Title	Status
224551	National Healthcare Safety Network (NHSN) Data Validation Study for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1340	ICR Reference No: 201912-0938-018
Status: Active	Previous ICR Reference No: 201908-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: National Healthcare Safety Network (NHSN) Data Validation Study for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) (CMS-10639)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/21/2020
	Date Received in OIRA: 12/23/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	36 Months From Approved	11/30/2021
Responses	12,000	0	6,000
Time Burden (Hours)	3,000	0	1,500
Cost Burden (Dollars)	0	0	0

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Abstract: For the PY 2021 study, CMS is proposing to select 150 facilities to participate in an NHSN Dialysis Event validation study by submitting 20 patient records covering two quarters of data reported in CY 2019.

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Authorizing Statute(s): US Code: 42 USC 1395R Name of Law: End State Renal Disease
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT70	Final or interim final rulemaking	84 FR 38330	08/06/2019

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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
National Healthcare Safety Network (NHSN) Data Validation Study for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)	CMS-10639, CMS-10639	Request Letter to Facilities Records ,   Request Letter to Facilities - List

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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	12,000	6,000	0	6,000	0	0
Annual Time Burden (Hours)	3,000	1,500	0	1,500	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 revision to an information collection request (ICR). The existing ICR covers the burden associated with the PY 2021 study, which had a total burden of $61,770 and 1,500 hours. The changes in burden associated with this amended ICR are due to the addition of the PY 2022 study, including the increase in the number of participating facilities. The annual hour burden associated with the PY 2022 study is 3,000. The annual burden associated with the PY 2022 study is $126,960.

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Annual Cost to Federal Government: $185,000

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.     Yes

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? Uncollected

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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: 12/23/2019

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