Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form

Forms and Documents

Document Name	Status
Form Form #6 Patient Safety Confidentiality Complaint Form Form and Instruction	New
Form Form #7 Attestation Form Form and Instruction	Removed
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 L -- Federal Register Notice.pdf Supplementary Document	2011-07-07
Attachment C -- PSO Guidance 02-25-11.pdf Supplementary Document	2011-07-07
Attachment B -- PSO Patient Safety Rule 02-25-11.pdf Supplementary Document	2011-07-07
Attachment A2 -- PSO Patient Safety Act 02-25-11.pdf Supplementary Document	2011-07-07
Attachment A1 -- PSO Public Health Act Section 901 02-25-11.pdf Supplementary Document	2011-07-07
Attachment J -- Common Formats Supplemental Details 03 15 2011.docx Supplementary Document	2011-07-06
Supporting Statement Part A PSO Reauthorization 10-17-2011.doc Supporting Statement A	2011-10-17

IC Document Collections

IC ID	Document Title	Status
198467	Patient Safety Confidentiality Complaint Form Form and Instruction	New
197285	Attestation Form Form and Instruction	Removed
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: 201107-0935-001
Status: Historical Active	Previous ICR Reference No: 201104-0935-004
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 10/31/2011
	Date Received in OIRA: 07/11/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2014	36 Months From Approved	06/30/2012
Responses	919	0	278
Time Burden (Hours)	75,764	0	101
Cost Burden (Dollars)	0	0	0

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Abstract: The Patient Safety and Quality Improvement Act of 2005 was enacted to provide an incentive for health care providers to work to improve patient safety. In order to implement the act, HHS issued the Patient Safety and Quality Improvement Final Rule which establishes a framework by which providers may voluntarily report information to PSOs. In addition, the Patient Safety Rule outlines the requirements that entities must meet to become PSOs and the process by which the Secretary will review and accept certifications and list PSOs. In December 2010, HHS issued Guidance Regarding Patient Safety Organizations' Reporting Obligations and the Patient Safety and Quality Improvement Act of 2005. On June 2nd, 2011 OMB approved Supplemental Attestations Regarding FDA Reporting Obligations Of PSOs, a new form to comply with this new Guidance. With this submission the Attestation Form has been incorporated into the other existing PSO forms.

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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:
0919-AA01	Final or interim final rulemaking	73 FR 70732	11/21/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 21744	04/18/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 37115	06/24/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
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	PSO Information Form
Common Formats	Form #7	Common Formats Complete Set of Forms
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
Attestation Form	Form #7	Attestation 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	919	278	0	605	36	0
Annual Time Burden (Hours)	75,764	101	0	74,959	704	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 burden estimates have changed for all of the PSO forms, except for the Patient Safety Confidentiality Complaint form, and the Common Formats. The burden estimates in the previous submission, which was a new collection, were developed prior to the full implementation of the PSO program. The new estimates were revised to reflect input on the forms and Common Formats received from PSOs, healthcare organizations, and providers at the AHRQ annual meetings, PSO annual meetings, and technical assistance calls with PSOs.

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Annual Cost to Federal Government: $2,037,390

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: 07/11/2011

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