View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0938-1210
ICR Reference No:
201905-0938-011
Status:
Historical 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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
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
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.
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
Agency Contact:
Denise King 410 786-1013 Denise.King@cms.hhs.gov
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:
05/30/2019
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