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
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.
$2,047,360
No
No
No
No
No
No
No
Erwin Brown 301 427-1652
erwin.brown@ahrq.hhs.gov
No
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.