Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form

Forms and Documents

Document Name	Status
Form Form #7 Attestation Form Form and Instruction	New
Form Form #1 Patient Safety Confidentiality Complaint Form Form and Instruction	Modified
Form Form #3 Information Form - Revised Form and Instruction	Modified
Form Form #2 Two Bona Fide Contracts Requirement Form Form and Instruction	Modified
Form Form #5 Disclosure Form - Revised Form and Instruction	Modified
Form Form #6 Certification for Continued Listing Form Form and Instruction	Modified
Form Form #4 Patient Safety Organization Certification for Initial Listing Form Form and Instruction	Modified
Attachment J -- 30 Day FR Notice.pdf Supplementary Document	2011-03-24
Memo to OMB.docx Supplementary Document	2011-03-24
Supporting Statement Part A -- PSO Attestation Form 3-24-2011.doc Supporting Statement A	2011-03-24

IC Document Collections

IC ID	Document Title	Status
197285	Attestation Form Form and Instruction	New
186804	Patient Safety Confidentiality Complaint 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	Patient Safety Organization Certification for Initial Listing Form Form and Instruction	Modified

ICR Details

OMB Control No: 0935-0143	ICR Reference No: 201104-0935-004
Status: Historical Active	Previous ICR Reference No: 201011-0935-003
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: 06/02/2011
	Date Received in OIRA: 04/12/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2012	6 Months From Approved	08/31/2011
Responses	278	0	183
Time Burden (Hours)	101	0	77
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. The Guidance addresses questions that have arisen regarding the obligations of PSOs where they or the organization of which they are a part are legally obligated under the FDCA and its implementing regulations to report certain information to the FDA and to provide FDA with access to its records, including access during an inspection of its facilities. This Guidance applies to all entities that seek to be or are PSOs or component PSOs that have mandatory FDA-reporting obligations under the FDCA and its implementing regulations or are organizationally related to such FDA-regulated reporting entities. In order to meet the requirements of the Guidance, AHRQ is requesting approval of supplemental attestations regarding FDA reporting obligations of PSOs form. This form is for entities to certify that they meet the obligations that an entity must meet to be listed and that a PSO must meet to remain listed when the entity or PSO is an FDA-regulated reporting entity or is organizationally related to an FDA-regulated reporting entity. This form will be used for less than one year and will be incorporated into the existing PSO forms with the submission on the renewal clearance later in the year.

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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	02/21/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 4748	01/27/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 10905	02/28/2011
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
Certification for Continued Listing Form	Form #6	Certification for Continued Listing Form
Attestation Form	Form #7	Attestation Form
Patient Safety Confidentiality Complaint Form	Form #1	Patient Safety Confidentiality Complaint Form
Two Bona Fide Contracts Requirement Form	Form #2	Two Bona Fide Contracts Requirement Form
Information Form - Revised	Form #3	Information Form
Patient Safety Organization Certification for Initial Listing Form	Form #4	Patient Safety Organization Certification for Initial Listing Form
Disclosure Form - Revised	Form #5	Disclosure Statement 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	278	183	0	95	0	0
Annual Time Burden (Hours)	101	77	0	24	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: No

Burden Reduction Due to:

Short Statement: Addition of a new form to the PSO Forms. The addition of the Attestation Form will add 24 burden hours annually to the existing data collection.

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Annual Cost to Federal Government: $7,500

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: 04/12/2011

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