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 Form 8 Attachment I: PSO Change of Listing Information Form and Instruction	New
Form Form #6 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 #7 Common Formats Form and Instruction	Modified
Attachment.C. PSO.Guidance.pdf Supplementary Document	2014-11-12
Attachment.B.PSO.Patient Safety Rule.pdf Supplementary Document	2014-11-12
Attachment.A.PSO.Patient Safety Act PDF.pdf Supplementary Document	2014-11-12
PSO OMB Supporting Statement Part A -- 10.29.2014.fine.2.ver29.doc Supporting Statement A	2014-11-12

IC Document Collections

IC ID	Document Title	Status
213835	Attachment I: PSO Change of Listing Information Form and Instruction	New
198467	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: 201411-0935-001
Status: Historical Active	Previous ICR Reference No: 201206-0935-003
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: 12/23/2014
	Date Received in OIRA: 11/14/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	36 Months From Approved
Responses	1,169	0	0
Time Burden (Hours)	100,704	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:
	79 FR 42013	07/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 58346	09/29/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Attachment I: PSO Change of Listing Information	Form 8	Attachment I: 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 #7	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
Patient Safety Confidentiality Complaint Form	Form #6	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	1,169	0	0	250	0	919
Annual Time Burden (Hours)	100,704	0	0	24,940	0	75,764
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: Certification for Continued Listing -- the estimated response time remains unchanged at eight hours with a decrease in the number of responses from 24 to16, which is 65% of the estimated 77 listed PSOs. The total burden hours have decreased 192 to 128 which represents a decrease of 64 hours. The estimated response rate is based on the average of continued listing forms submitted by listed PSOs with approximately two thirds of PSOs seeking continued listing. Disclosure Statement Form -- the estimated response time has remains unchanged at three hours with a decrease in the number of responses from seven to two; the total burden hours have decreased from 21 to 6 which represents a decrease of 15 hours. The estimated response rate is based on the average of disclosure statement forms submitted by listed PSOs. PSO Profile Form -- the estimated response time remains unchanged at three hours with a decrease in the number of responses from 80 to 77; the total burden hours have decreased from 240 to 231 which represents a decrease of nine hours. The estimated response rate is based on the average of number of listed PSOs.

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Annual Cost to Federal Government: $5,443,220

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 11/14/2014

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