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:
202208-0938-022
Status:
Active
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
OIRA Conclusion Action:
Approved with change
Conclusion Date:
01/04/2023
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/25/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/2026
36 Months From Approved
Responses
7,770
0
0
Time Burden (Hours)
1,210
0
0
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:
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
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
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
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.
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
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:
08/25/2022
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