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 #5 Information Form Form and Instruction	New
Form Form #4 Two-Contract Requirement Form Form and Instruction	New
Form Form #3 Disclosure Form Form and Instruction	New
Form Form #2 Recertification Form Form and Instruction	New
Form Form #1 Patient Safety Organization Certification Form Form and Instruction	New
Attachment B -- Excerpts from the Notice of Proposed Rulemaking.doc Supplementary Document	2008-04-21
Attachment I -- 60 Day Federal Register Notice.pdf Supplementary Document	2008-04-21
Attachment A-2 -- Patient Safety & Quality Improvement Act of 2005.pdf Supplementary Document	2008-04-21
Notice of Proposed Rulemaking 2-12-2008.pdf Supplementary Document	2008-04-21
Attachment A-1 -- Section 901 Public Health Service Act.pdf Supplementary Document	2008-04-21
Supporting Statement Part A 2-27-2008.doc Supporting Statement A	2008-04-21

IC Document Collections

IC ID	Document Title	Status
184639	Patient Safety Confidentiality Complaint Form Form and Instruction	New
184638	Information Form Form and Instruction	New
184637	Two-Contract Requirement Form Form and Instruction	New
184636	Disclosure Form Form and Instruction	New
184635	Recertification Form Form and Instruction	New
184634	Patient Safety Organization Certification Form Form and Instruction	New

ICR Details

OMB Control No: 0935-0143	ICR Reference No: 200804-0935-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 10/01/2008
	Date Received in OIRA: 04/25/2008
Terms of Clearance: Comment Filed

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	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, 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	Proposed rulemaking	73 FR 8112	02/12/2008

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 9336	02/20/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 21349	04/21/2008
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 Organization Certification Form	Form #1	Patient Safety Organization Certification Form
Recertification Form	Form #2	Recertification Form
Disclosure Form	Form #3	Disclosure Form
Two-Contract Requirement Form	Form #4	Two-Contract Requirement Form
Information Form	Form #5	Information Form
Patient Safety Confidentiality Complaint Form	Form #6	Patient Safety Confidentiality Complaint Form

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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: This is a new information 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]? 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)? Uncollected

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: 04/25/2008

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