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
CMS-10639 NHSN_Supporting_Statement B_CY2018 July 30 2018 .docx Supporting Statement B	2018-08-28
CMS-10639 NHSN Supporting Statement A.ESRDQIP 28August2018.docx Supporting Statement A	2018-08-28

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)	Modified

ICR Details

OMB Control No: 0938-1340	ICR Reference No: 201805-0938-006
Status: Historical Active	Previous ICR Reference No: 201708-0938-005
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: 08/30/2018
	Date Received in OIRA: 05/08/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	07/31/2020
Responses	700	0	35
Time Burden (Hours)	175	0	88
Cost Burden (Dollars)	0	0	0

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Abstract: Section 1881(h) of the Social Security Act, as amended by section 153(h) of the Medicare Improvements for Patients and Providers Act, authorizes the establishment of a quality incentive program for renal dialysis facilities. CMS first introduced the NHSN Bloodstream Infection Clinical Measure into the ESRD QIP for PY 2016. Continuing in PY 2020 (CY 2018), CMS will conduct a data validation study of data reported to NHSN. It is imperative that the data validation continue to include a greater number of facilities (35 facilities in CY 2018).

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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-AT04	Final or interim final rulemaking	82 FR 50738	11/01/2017

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 31190	07/05/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 50738	11/01/2017
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)

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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	700	35	0	0	665	0
Annual Time Burden (Hours)	175	88	0	0	87	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: This package was previously approved in 2017 with a total burden of $3,287.68 and 88 hours for CY 2017. This PRA estimates that the total burden is $6,975.50 and 175 hours for CY 2018. The difference in this estimate is due to updates to the number of patient records requested and the wage estimate.

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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: 05/08/2018

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