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

Forms and Documents

Document Name	Status
CMS-10639_NHSN Supporting Statement B_FY2017_Revised-2.7.12.2017.doc Supporting Statement B	2017-07-14
CMS-10639 NHSN Data Validation ESRD QIP SSA CLEAN_12July2017.docx Supporting Statement A	2017-07-14

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)	New

ICR Details

OMB Control No: 0938-1340	ICR Reference No: 201611-0938-014
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: (CMS-10639) National Healthcare Safety Network (NHSN) Data Validation Study for the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/27/2017
	Date Received in OIRA: 11/25/2016
Terms of Clearance:

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

---

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. Beginning in PY 2019 (CY 2017), CMS is going to conduct an increased data validation of data reported to NHSN. It is imperative that the data validation study be expanded to include a greater number of facilities.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AS83	Final or interim final rulemaking	81 FR 77834	11/04/2016

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 51147	08/03/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 77834	11/04/2016
Did the Agency receive public comments on this ICR? No

---

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)

---

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	35	0	0	35	0	0
Annual Time Burden (Hours)	88	0	0	88	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 information collection.

---

Annual Cost to Federal Government: $185,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

---

Common Form ICR:  No

---

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: 11/25/2016

---