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

Forms and Documents

Document Name	Status
Form 8 Attachment L: PSO Voluntary Relinquishment Form Form and Instruction	New
Form Form 6 Attachment J: PSO Change of Listing Information Form and Instruction	Modified
Form Form #7 Attachment K: OCR Patient Safety Confidentiality Complaint Form Form and Instruction	Modified
Form Form #1 Patient Safety Organization Certification for Initial Listing Form Form and Instruction	Modified
Form Form #5 Information Form - Revised Form and Instruction	Modified
Form Form #3 Two Bona Fide Contracts Requirement Form Form and Instruction	Modified
Form Form #4 Disclosure Form - Revised Form and Instruction	Modified
Form Form #2 Certification for Continued Listing Form Form and Instruction	Modified
Form Form #9 Common Formats Form and Instruction	Modified
Attachment.D.Patient Safety Act.PSWP.Providers.External.Obligations.AHRQ.11.2017.pdf Supplementary Document	2018-06-06
Attachment.C.Guidance Regarding Patient Safety Organizations’ Reporting FDA.Obligations.AHRQ.11.2017.pdf Supplementary Document	2018-08-30
Attachment.B.Patient Safety Rule.2008.AHRQ.11.2017pdf.pdf Supplementary Document	2018-08-30
Attachment.A.Patient Safety Act PDF.2005.AHRQ.11.2017.pdf Supplementary Document	2018-06-06
PSO OMB Supporting Statement Part A -- ver.21.August.2018.fine.final.docx Supporting Statement A	2018-09-17

IC Document Collections

IC ID	Document Title	Status
231738	Attachment L: PSO Voluntary Relinquishment Form Form and Instruction	New
213835	Attachment J: PSO Change of Listing Information Form and Instruction	Modified
198467	Attachment K: OCR Patient Safety Confidentiality Complaint Form Form and Instruction	Modified
186804	Patient Safety Organization Certification for Initial Listing Form Form and Instruction	Modified
186803	Information Form - Revised Form and Instruction	Modified
186802	Two Bona Fide Contracts Requirement Form Form and Instruction	Modified
186801	Disclosure Form - Revised Form and Instruction	Modified
186800	Certification for Continued Listing Form Form and Instruction	Modified
186799	Common Formats Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0143	ICR Reference No: 201806-0935-001
Status: Active	Previous ICR Reference No: 201411-0935-001
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: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/14/2018
	Date Received in OIRA: 09/18/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2021	36 Months From Approved
Responses	1,219	0	0
Time Burden (Hours)	100,725	0	0
Cost Burden (Dollars)	0	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

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:
	83 FR 8274	02/26/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 25668	06/04/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Attachment L: PSO Voluntary Relinquishment Form	8	Attachment L: PSO Voluntary Relinquishment Form
Attachment J: PSO Change of Listing Information	Form 6	Attachment J: PSO Change of Listing Information
Patient Safety Organization Certification for Initial Listing Form	Form #1	Patient Safety Organization Certification for Initial Listing Form
Two Bona Fide Contracts Requirement Form	Form #3	PSO Two Bona Fide Contracts Requirement Form
Information Form - Revised	Form #5	Attachment H: PSO Profile Form
Common Formats	Form #9	Common Formats Supplemental Details
Disclosure Form - Revised	Form #4	PSO Disclosure Statement Form
Certification for Continued Listing Form	Form #2	PSO Certification for Continued Listing Form
Attachment K: OCR Patient Safety Confidentiality Complaint Form	Form #7	Attachment K: OCR Patient Safety Confidentiality Complaint Form

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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	1,219	0	0	50	0	1,169
Annual Time Burden (Hours)	100,725	0	0	21	0	100,704
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 100,704 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, and the OCR Patient Safety Confidentiality Form. The estimated burden hours for the current ICR, which now includes the new PSO Voluntary Relinquishment Form, are 100,722.88 which represent an increase of 18.88 hours.

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Annual Cost to Federal Government: $4,198,560

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

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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: 09/18/2018

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