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 - Revised Form and Instruction	New
Form Form #5 Information Form - Revised Form and Instruction	New
Form Form #4 Two-Contract Requirement Form - Revised Form and Instruction	New
Form Form #3 Disclosure Form - Revised Form and Instruction	New
Form Form #2 Recertification Form - Revised Form and Instruction	New
Form Form #1 Patient Safety Organization Certification Form - Revised Form and Instruction	New
Form Form #6 Patient Safety Confidentiality Complaint Form Form and Instruction	Removed
Form Form #5 Information Form Form and Instruction	Removed
Form Form #4 Two-Contract Requirement Form Form and Instruction	Removed
Form Form #3 Disclosure Form Form and Instruction	Removed
Form Form #2 Recertification Form Form and Instruction	Removed
Form Form #1 Patient Safety Organization Certification Form Form and Instruction	Removed
Supporting Statement Part A 2Oct08_rev (2).doc Supporting Statement A	2008-10-02
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

IC Document Collections

IC ID	Document Title	Status
186804	Patient Safety Confidentiality Complaint Form - Revised Form and Instruction	New
186803	Information Form - Revised Form and Instruction	New
186802	Two-Contract Requirement Form - Revised Form and Instruction	New
186801	Disclosure Form - Revised Form and Instruction	New
186800	Recertification Form - Revised Form and Instruction	New
186799	Patient Safety Organization Certification Form - Revised Form and Instruction	New
184639	Patient Safety Confidentiality Complaint Form Form and Instruction	Removed
184638	Information Form Form and Instruction	Removed
184637	Two-Contract Requirement Form Form and Instruction	Removed
184636	Disclosure Form Form and Instruction	Removed
184635	Recertification Form Form and Instruction	Removed
184634	Patient Safety Organization Certification Form Form and Instruction	Removed

ICR Details

OMB Control No: 0935-0143	ICR Reference No: 200810-0935-001
Status: Historical Active	Previous ICR Reference No: 200804-0935-003
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 10/02/2008
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/06/2008
	Date Received in OIRA: 10/02/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2009	6 Months From Approved
Responses	183	0	0
Time Burden (Hours)	77	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).

Emergency Justfication: AHQR is requesting an emergency review of this collection because it has been decided that listing of PSOs should take place during the period between now and the effective date of the final rule (i.e., interim period). An Interim Guidance document, reviewed and approved by OMB, will provide guidance during this interim period to entities seeking listing and entities that are listed as PSOs during this interim period. These forms have been revised to reflect only the statutory requirements and the provisions of the proposed rule that the Interim Guidance document notes are binding.

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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

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Information Form	Form #5	Information Form
Patient Safety Confidentiality Complaint Form - Revised	Form #6	Patient Safety Confidentiality Complaint Form 10/2/2008
Patient Safety Confidentiality Complaint Form	Form #6	Patient Safety Confidentiality Complaint Form
Two-Contract Requirement Form - Revised	Form #4	Two-Contract Requirement Form 10/2/2008
Information Form - Revised	Form #5	Information Form 10/2/2008
Patient Safety Organization Certification Form - Revised	Form #1	Patient Safety Organization Certification Form 10/2/2008
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
Disclosure Form - Revised	Form #3	Disclosure Form 10/2/2008
Recertification Form - Revised	Form #2	Recertification Form 10/2/2008

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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	0	0	183	0	0
Annual Time Burden (Hours)	77	0	0	77	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: Changing Regulations

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: 10/02/2008

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