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

Forms and Documents

Document Name	Status
Form CMS-10455 Documentation of information of deaths related to 2 point soft wrist restaints Form and Instruction	Modified
Form CMS-10455 Form completetion Form and Instruction	Modified
Form CMS-10455 Training Form and Instruction	Removed
CMS-10455 Supporting Statement. 08.12.22.docx Supporting Statement A	2022-08-25

IC Document Collections

IC ID	Document Title	Status
255603	Entering information into medical record	New
236196	Documentation of information of deaths related to 2 point soft wrist restaints Form and Instruction	Modified
236195	Form completetion Form and Instruction	Modified
205636	Training Form and Instruction	Removed

ICR Details

OMB Control No: 0938-1210	ICR Reference No: 202208-0938-022
Status: Received in OIRA	Previous ICR Reference No: 201905-0938-011
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Report of a Hospital Dealth Associated with Restraint or Seclusion (CMS-10455)
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/25/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	7,770	0
Time Burden (Hours)	1,210	0
Cost Burden (Dollars)	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:
	87 FR 35784	06/13/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 51985	08/24/2022
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	CMS-10455	REPORT OF A HOSPITAL DEATH ASSOCIATED WITH THE USE OF RESTRAINT OR SECLUSION
Entering information into medical record
Form completetion	CMS-10455	Screenshots of Electronic Submission
Training	CMS-10455	Health Death Report Form

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ICR Summary of Burden

	Total Request	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	7,770	0	0	-3,156	0	10,926
Annual Time Burden (Hours)	1,210	0	0	-6,096	0	7,306
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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: As the above table shows, the number of responses has decreased by 7,789. The total number of annual burden hours has decreased by 6,096 hours and the total annual cost burden has increased by $62,160. These changes can be explained by several factors. The decrease in the number of responses and burden hours can be attributed to the fact that the number of responses and cost burden in the previous PRA package was higher than usual due to the addition of a one-time burden that was added for training hospital and CAH staff in the use of the electronic format CMS-10455 that was released with the previous PRA package. As this was a one-time burden, we have not included this burden in this PRA package. Thus, the number of responses and time burden have decreased in the current PRA package.

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Annual Cost to Federal Government: $121,252

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? No

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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: 08/25/2022

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