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:
0935-0143
ICR Reference No:
202107-0935-005
Status:
Historical Active
Previous ICR Reference No:
201806-0935-001
Agency/Subagency:
HHS/AHRQ
Agency Tracking No:
Title:
Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
09/16/2021
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/04/2021
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2024
36 Months From Approved
11/30/2021
Responses
1,236
0
1,219
Time Burden (Hours)
100,796
0
100,725
Cost Burden (Dollars)
0
0
0
Abstract:
The Patient Safety and Quality Improvement Act of 2005 (hereafter the Patient Safety Act), 42 U.S.C. 299b-21 to 299b-26, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine's 1999 report, To Err is Human: Building a Safer Health System. The goal of the statute is to improve patient safety by providing an incentive for health care providers to work voluntarily with experts in patient safety to reduce risks and hazards to the safety and quality of patient care. The Patient Safety Act signifies the Federal Government's commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs will be able to identify patterns of failures and propose measures to eliminate or reduce patient safety risks and hazards.
Authorizing Statute(s):
US Code:
42 USC 299
Name of Law: Healthcare Research and Quality Act of 1999
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:
86 FR 26036
05/12/2021
30-day Notice:
Federal Register Citation:
Citation Date:
86 FR 41036
07/30/2021
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Attachment J: PSO Change of Listing Information
Form 6
Attachment H: PSO Change of Listing Information
Attachment K: OCR Patient Safety Confidentiality Complaint Form
Form #7
Attachment I: OCR Patient Safety Confidentiality Complaint Form
Attachment L: PSO Voluntary Relinquishment Form
8
Attachment J: PSO Voluntary Relinquishment Form
Certification for Continued Listing Form
Form #2
Attachment D: PSO Certification for Continued Listing Form
Common Formats
Form #9
Attachment K: Common Formats Details
Disclosure Form - Revised
Form #4
Attachment F: PSO Disclosure Statement Form
Information Form - Revised
Form #5
Attachment G: PSO Profile Form
Patient Safety Organization Certification for Initial Listing Form
Form #1
Attachment C: PSO Certification for Initial Listing Form
Two Bona Fide Contracts Requirement Form
Form #3
Attachment E: PSO Two Bona Fide Contracts Requirement 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
1,236
1,219
0
17
0
0
Annual Time Burden (Hours)
100,796
100,725
0
71
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The previous information collection request (ICR) included an estimate of 100,724.91 total burden hours for the Common Formats and the following forms: PSO Certification for Initial Listing Form, PSO Certification for Continued Listing Form, PSO Two Bona Fide Contracts Requirement Form, PSO Disclosure Statement Form, PSO Profile Form, PSO Change of Listing Form, the OCR Patient Safety Confidentiality Form, and the PSO Voluntary Relinquishment Form. The estimated burden hours for the current ICR are 100,795.83 that represent an increase of 70.92 hours. For this submission, the burden of the forms remains unchanged. A few minor edits for clarity are being made to some of the existing forms which have not affected the burden estimates. The increase of 70.92 burden hours is attributed to the changes in the number of respondents for the PSO forms that are described below.
Annual Cost to Federal Government:
$2,047,360
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:
Erwin Brown 301 427-1652 erwin.brown@ahrq.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:
08/04/2021
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