Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats
Extension without change of a currently approved collection
No
Regular
08/04/2021
table that charts list comparision
Requested
Previously Approved
36 Months From Approved
11/30/2021
1,236
1,219
100,796
100,725
0
0
The Patient Safety and Quality Improvement Act of 2005 (hereafter the Patient Safety Act), 42 U.S.C. 299b-21 to 299b-26, 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. The Patient Safety Act signifies the Federal Government's commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs will be able to identify patterns of failures and propose measures to eliminate or reduce patient safety risks and hazards.
US Code:
42 USC 299
Name of Law: Healthcare Research and Quality Act of 1999
The previous information collection request (ICR) included an estimate of 100,724.91 total burden hours for the Common Formats and the following forms: PSO Certification for Initial Listing Form, PSO Certification for Continued Listing Form, PSO Two Bona Fide Contracts Requirement Form, PSO Disclosure Statement Form, PSO Profile Form, PSO Change of Listing Form, the OCR Patient Safety Confidentiality Form, and the PSO Voluntary Relinquishment Form.
The estimated burden hours for the current ICR are 100,795.83 that represent an increase of 70.92 hours.
For this submission, the burden of the forms remains unchanged. A few minor edits for clarity are being made to some of the existing forms which have not affected the burden estimates. The increase of 70.92 burden hours is attributed to the changes in the number of respondents for the PSO forms that are described below.
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:
(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;
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.
Attachment L: PSO Voluntary Relinquishment Form