Report of a Hospital Dealth Associated with Restraint or Seclusion

Forms and Documents

Document Name	Status
Form CMS-10455 Hospital Restraint/Seclusion Death Report Worksheet Form	New
Hospital restraint and seclusion death report crosswalk for changes 22 Jan 13.doc Supplementary Document	2013-01-25
CMS-10455 Supporting Statement A.docx Supporting Statement A	2013-01-25

IC Document Collections

IC ID	Document Title	Status
205636	Hospital Restraint/Seclusion Death Report Worksheet Form	New

ICR Details

OMB Control No: 0938-1210	ICR Reference No: 201301-0938-009
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: 18578
Title: Report of a Hospital Dealth Associated with Restraint or Seclusion
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 without change	Conclusion Date: 08/23/2013
	Date Received in OIRA: 01/31/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved
Responses	24,500	0	0
Time Burden (Hours)	8,085	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Hospital Restraint/Seclusion Death Report Worksheet historically has been used by RO's internally as a data collection tool for hospitals reporting restraint/seclusion deaths as required by 482.13. In response to the Executive Order 13563 by reducing unnecessarily burdensome rules and thereby increasing the ability of hospitals and CAHs to devote resources to providing high quality patient care. The Medicare and Medicaid Programs; Reform of Hospital and Critical Access Hospital Conditions of Participation CMS-3244-F final rule responds. Within this rule is the change to 482.13 reducing the burden of reporting 2-point soft wrist restraint deaths. Additionally, it increases the methods for which hospitals may report all other restraint/seclusion related deaths, to include telephone, facsimile, and electronic. The Hospital Restraint/Seclusion Death Report Worksheet will now be used by all hospitals for required reporting by facsimile and electronic. Sections 1861(e)(1) through (8) of the Social Security Act (the Act) provide that a hospital participating in the Medicare program must meet certain specified requirements. Section 1861(e)(9) of the Act specifies that a hospital also must meet such other requirements as the Secretary finds necessary in the interest of the health and safety of individuals furnished services in the institution. Under this authority, the Secretary has established regulatory requirements that a hospital must meet to participate in Medicare at 42 CFR Part 482, CoPs for Hospitals. Section 1905(a) of the Act provides that Medicaid payments from States may be applied to hospital services. Under regulations at 42 CFR 440.10(a)(3)(iii), 42 CFR 440.20(a)(3)(ii), and 42 CFR 440.140, hospitals are required to meet the Medicare CoPs in order to participate in Medicaid.

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Authorizing Statute(s): US Code: 42 USC 186 Name of Law: Social Security Act
   US Code: 42 USC 591, 592, 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
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 69847	11/21/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 6331	01/30/2012
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
Hospital Restraint/Seclusion Death Report Worksheet	CMS-10455, CMS-10455, CMS-10455	Health Death Report Form ,   Intake ,   Screenshot

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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	24,500	0	0	24,500	0	0
Annual Time Burden (Hours)	8,085	0	0	8,085	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 collection.

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Annual Cost to Federal Government: $153,125

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

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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: 01/31/2013

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