Report of a Hospital Dealth Associated with Restraint or Seclusion (CMS-10455)

Forms and Documents

Document Name	Status
Form CMS-10455 Submission of Form Form and Instruction	New
Form CMS-10455 Training Form and Instruction	Modified
CMS-10455 Response_to_Public_Comments. 05.10.19.doc Supplementary Document	2019-05-20
CMS-10455 Supporting Statement. 05.10.19.docx Supporting Statement A	2019-05-28

IC Document Collections

IC ID	Document Title	Status
236196	Documentation of information of deaths related to 2 point soft wrist restaints	New
236195	Submission of Form Form and Instruction	New
205636	Training Form and Instruction	Modified

ICR Details

OMB Control No: 0938-1210	ICR Reference No: 201905-0938-011
Status: Active	Previous ICR Reference No: 201802-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: 18578
Title: Report of a Hospital Dealth Associated with Restraint or Seclusion (CMS-10455)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/09/2019
	Date Received in OIRA: 05/30/2019
Terms of Clearance: Previous terms continue: The program will update the expiration date on the form within two weeks of approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	07/31/2021
Responses	10,926	0	6,389
Time Burden (Hours)	7,306	0	2,619
Cost Burden (Dollars)	0	0	0

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Abstract: The CMS 10455 Report of a Hospital Death in Restraint or Seclusion form is utilized for the purpose of determining cases that warrant on-site investigation to determine the hospital’s compliance with the Medicare Condition of Participation (CoP) for patient’s rights. Based on information gathered from CMS Regional Offices (ROs), the current collection tool associated with this package did not provide the needed information to thoroughly evaluate whether the case warrants an on-site investigation. The ROs provided feedback for data needed on the CMS 10455 form to evaluate whether the case warrants an on-site investigation. The collection tool was revised based on the ROs need for additional information to assess for compliance with CoPs as well as the health and safety of patients requiring the use of restraint and/or seclusion.

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Authorizing Statute(s): US Code: 42 USC 591, 592, Name of Law: Public Health Service Act
   US Code: 42 USC 186 Name of Law: Social Security 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:
	84 FR 4075	02/14/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 22850	05/20/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Documentation of information of deaths related to 2 point soft wrist restaints
Submission of Form	CMS-10455	Screenshots of Electronic Submission
Training	CMS-10455	Health Death Report 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	10,926	6,389	0	4,537	0	0
Annual Time Burden (Hours)	7,306	2,619	0	4,687	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: The total time burden associated with the submission of the electronic CMS-10455 form will increase from 2,619 hours to 7,306 hours.

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Annual Cost to Federal Government: $147,708

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.     No

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? 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: 05/30/2019

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