Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form

Forms and Documents

Document Name	Status
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 B -- Patient Safety Rule Nov 21 2008.pdf Supplementary Document	2009-04-02
Attachment A2 -- Patient Safety Act PL 109 41.pdf Supplementary Document	2009-04-02
Attachment A1 -- Section 901 of the Public Health Service Act.pdf Supplementary Document	2009-04-02
Supporting Statement Part A PSO.markup.06.17.09.doc Supporting Statement A	2009-08-06

IC Document Collections

IC ID	Document Title	Status
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: 200904-0935-001
Status: Historical Active	Previous ICR Reference No: 200812-0935-003
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/05/2009
	Date Received in OIRA: 04/14/2009
Terms of Clearance: This ICR is approved, consistent with revised supporting statement, for a period of 2 years. During that time and prior to renewal, AHRQ agrees to seek comment on the burden associated with assessing whether an entity will consider seeking listing as a PSO. AHRQ could, for example, solicit comment on this burden either through an FR notice or by consulting with a handful of PSOs that represent the variety of PSOs that exist today (e.g. the sample of PSOs would vary on key dimensions, e.g. small vs big PSOs, experienced vs new PSO, etc). AHRQ further agrees to submit change requests for non-substantive "technical" changes to the PSO common formats and ICR Revisions for substantive changes, prior to letting those changes go into effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2011	36 Months From Approved	12/31/2009
Responses	183	0	183
Time Burden (Hours)	77	0	77
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, see Attachment A-2), signed into law on July 29, 2005, 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. When specific statutory requirements are met by organizations seeking to offer expert analytic services regarding patient safety, the information collected and the analyses and deliberations regarding the information, receive Federal confidentiality and privilege protections under this legislation. The Secretary of the Department of Health and Human Services delegated authority to the Director of the Office for Civil Rights (OCR) to enforce the confidentiality protections of the patient safety legislation and delegated authority to the Director of the Agency for Healthcare Research and Quality (AHRQ) to implement and administer the rest of the statute's provisions (Federal Register, Vol. 71, No. 95, May 17, 2006, p. 28701-2).

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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 8112	02/12/2008

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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:
	74 FR 14558	03/31/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
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
Certification for Continued Listing Form	Form #6	Certification for Continued Listing 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	183	183	0	0	0	0
Annual Time Burden (Hours)	77	77	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $15,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 04/14/2009

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