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Federal forms, ICRs, and supporting documents

Information Collection Request

Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats

ICR 202410-0935-002 · OMB 0935-0143 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form Form 7 Attachment J_PSO Voluntary Relinquishment Form Form and Instruction Modified Repair queued
Form Form 6 Attachment H_PSO Change of Listing Information Form and Instruction Modified Repair queued
Form Form 8 Attachment I_OCR Complaint Consent Form Form and Instruction Modified Repair queued
Form Form 1 Attachment C_Patient Safety Organization Certification for Initial Listing Form Form and Instruction Modified Repair queued
Form Form 5 Attachment G_PSO Profile Form Form and Instruction Modified Repair queued
Form Form 3 Attachment E_PSO Two Bona Fide Contracts Requirement Form Form and Instruction Modified Repair queued
Form Form 4 Attachment F_PSO Disclosure Statement Form Form and Instruction Modified Repair queued
Form Form 2 Attachment D_PSO Certification for Continued Listing Form Form and Instruction Modified Repair queued
Form Form 9 Attachment K_AHRQ Common Formats Form and Instruction Modified Repair queued
Attachment B_Patient Safety and Quality Improvement Rule-2008.pdf Supplementary Document Uploaded 2024-10-16 Repair queued
Attachment A_Patient Safety and Quality Improvement Act of 2005.pdf Supplementary Document Uploaded 2024-10-16 Repair queued
Supporting Statement Part A_PSO Certification and Related Forms 0934-0143.docx Supporting Statement A Uploaded 2024-10-11 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
231738 Attachment J_PSO Voluntary Relinquishment Form Form and Instruction Modified
213835 Attachment H_PSO Change of Listing Information Form and Instruction Modified
198467 Attachment I_OCR Complaint Consent Form Form and Instruction Modified
186804 Attachment C_Patient Safety Organization Certification for Initial Listing Form Form and Instruction Modified
186803 Attachment G_PSO Profile Form Form and Instruction Modified
186802 Attachment E_PSO Two Bona Fide Contracts Requirement Form Form and Instruction Modified
186801 Attachment F_PSO Disclosure Statement Form Form and Instruction Modified
186800 Attachment D_PSO Certification for Continued Listing Form Form and Instruction Modified
186799 Attachment K_AHRQ Common Formats Form and Instruction Modified
ICR Details
0935-0143 202410-0935-002
Received in OIRA 202107-0935-005
HHS/AHRQ
Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats
Reinstatement with change of a previously approved collection   No
Regular 10/16/2024
  Requested Previously Approved
36 Months From Approved
1,240 0
100,811 0
0 0
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.
US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  
None
Not associated with rulemaking
  89 FR 65629 08/12/2024
89 FR 83499 10/16/2024
No
  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 1,240 0 0 4 0 1,236
Annual Time Burden (Hours) 100,811 0 0 15 0 100,796
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The number of responses and burden hours is essentially unchanged.
$1,373,675
No
    No
    No
No
No
No
No
Michelle Roberts 301 427-1645 [email protected]
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/16/2024