Agency Information Collection Activities: Proposed Collection; Comment Request

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Published

July 30, 2021

Issuing agencies

Health and Human Services DepartmentAgency for Healthcare Research and Quality

Abstract

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.'' This proposed information collection was previously published in the Federal Register on May 12, 2021 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

Full Text

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<title>Federal Register, Volume 86 Issue 144 (Friday, July 30, 2021)</title>
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[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41036-41039]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16326]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Health and
Human Services (HHS).

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) reapprove the proposed information
collection project ``Patient Safety Organization Certification for
Initial Listing and Related Forms, Patient Safety Confidentiality
Complaint Form, and Common Formats.'' This proposed information
collection was previously published in the Federal Register on May 12,
2021 and allowed 60 days for public comment. AHRQ did not receive
substantive comments from members of the public. The purpose of this
notice is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by August 30, 2021.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
<a href="/cdn-cgi/l/email-protection#3a5e5548534914565f5c51554d534e407a7b72686b14525249145d554c"><span class="__cf_email__" data-cfemail="dabeb5a8b3a9f4b6bfbcb1b5adb3aea09a9b92888bf4b2b2a9f4bdb5ac">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Patient Safety Organization Certification for Initial Listing and
Related Forms, Patient Safety Confidentiality Complaint Form, and
Common Formats''

AHRQ invites the public to comment on this proposed information
collection. The Patient Safety and Quality Improvement Act of 2005
(Patient Safety Act), 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 create a national
learning system. By providing incentives of nation-wide confidentiality
and legal privilege, the Patient Safety Act learning system improves
patient safety and quality 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 are able to identify patterns of failures and
propose measures to eliminate or reduce risks and hazards.
In order to implement the Patient Safety Act, the Department of
Health and Human Services (HHS) issued the Patient Safety and Quality
Improvement Final Rule (Patient Safety Rule) which became effective on
January 19, 2009. The Patient Safety Rule outlines the requirements
that entities must meet to become and remain listed as PSOs, the

[[Page 41037]]

process by which the Secretary of HHS (Secretary) will accept
certifications and list PSOs, and provisions pertaining to the
confidentiality and privilege protections for patient safety work
product (PSWP).
When specific statutory requirements are met, the information
collected and the analyses and deliberations regarding the information
receive confidentiality and privilege protections under this
legislation. The Secretary delegated authority to the Director of the
Office for Civil Rights (OCR) to interpret and enforce the
confidentiality protections of the Patient Safety Act (Federal
Register, Vol. 71, No. 95, May 17, 2006, p. 28701-2). Civil money
penalties may be imposed for knowing or reckless impermissible
disclosures of PSWP. AHRQ implements and administers the rest of the
statute's provisions.
Pursuant to the Patient Safety Rule (42 CFR 3.102), an entity that
seeks to be listed as a PSO by the Secretary must certify that it meets
certain requirements and, upon listing, would meet other criteria. To
remain listed for renewable three-year periods, a PSO must re-certify
that it meets these obligations and would continue to meet them while
listed. The Patient Safety Act and Patient Safety Rule also impose
other obligations discussed below that a PSO must meet to remain
listed. In accordance with the requirements of the Patient Safety Rule
(see, e.g., 42 CFR 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), and
3.112), the entities seeking to be listed and to remain listed must
complete the proposed forms, in order to attest to compliance with
statutory criteria and the corresponding regulatory requirements.

Method of Collection

With this submission, AHRQ is requesting approval of the following
proposed administrative forms:
1. PSO Certification for Initial Listing Form. This form,
containing certifications of eligibility and a capacity and intention
to comply with statutory criteria and regulatory requirements, is to be
completed, in accordance with 42 U.S.C. 299b-24(a)(1), and the above-
cited regulatory certification provisions, by an entity seeking to be
listed by the Secretary as a PSO for an initial three-year period.
2. PSO Certification for Continued Listing Form. In accordance with
42 U.S.C. 299b-24(a)(2) and the above-cited regulatory certification
provisions, this form is to be completed by a listed PSO seeking
continued listing by the Secretary as a PSO for each successive three-
year period.
3. PSO Two Bona Fide Contracts Requirement Certification Form. To
remain listed, a PSO must meet a statutory requirement in 42 U.S.C.
299b-24(b)(1)(C) that it has contracts with more than one provider,
within successive 24-month periods, beginning with the date of the
PSO's initial listing. This form is to be used by a PSO to certify
whether it has met this statutory requirement and the corresponding
regulatory provision.
4. PSO Disclosure Statement Form. This form provides detailed
instructions to a PSO regarding the disclosure statement it must submit
and provides for the required certification by the PSO of the
statement's accuracy in accordance with the 42 U.S.C. 299b-24(b)(1)(E),
when it (i) has a contract with a provider to carry out patient safety
activities and (ii) it has financial, reporting, or contractual
relationship(s) with that contracting provider or is not managed,
controlled, and operated independently from that contracting provider.
In accordance with the Patient Safety Act and the Patient Safety Rule,
the Secretary is required to review each such report and make public
findings as to whether a PSO can fairly and accurately carry out its
responsibilities.
5. PSO Profile Form. This form is designed to collect a minimum
level of voluntary data necessary to develop aggregate statistics
relating to PSOs, the types of providers they work with, and their
general location in the US. The PSO Profile is intended to be completed
annually by all PSOs that are ``AHRQ-listed'' during any part of the
previous calendar year. This information is collected by AHRQ's PSO
Privacy Protection Center (PSOPPC) and is used to populate the AHRQ PSO
selection tool on the AHRQ PSO website, to generate slides presented at
the PSO Annual Meeting, and to develop content for the annual report
required by 42 U.S.C. 299b-2(b)(2), the AHRQ National Healthcare
Quality and Disparities Report.
6. PSO Change of Listing Information Form. The Secretary is
required under 42 U.S.C. 299b-24(d) to maintain a publicly available
list of PSOs. Under the Patient Safety Rule, that list includes, among
other information, each PSO's current contact information. The Patient
Safety Rule, at 42 CFR 3.102(a)(1)(vi), also requires that, during its
period of listing, a PSO must promptly notify the Secretary of any
changes in the accuracy of the information submitted for listing.
7. PSO Voluntary Relinquishment Form. A PSO may voluntarily
relinquish its status as a PSO for any reason. Pursuant to 42 CFR
3.108(c)(2), in order for the Secretary to accept a PSO's notification
of voluntary relinquishment, the notice must contain certain
attestations and future contact information. This form provides an
efficient manner for a PSO seeking voluntary relinquishment to provide
all of the required information.
OCR is requesting approval of the following administrative form:
Patient Safety Confidentiality Complaint Form. The purpose of this
collection is to allow OCR to collect the minimum information needed
from individuals filing patient safety confidentiality complaints with
OCR so that there is a basis for initial processing of those
complaints.
In addition, AHRQ is requesting approval for a set of common
definitions and reporting formats (Common Formats). As authorized by 42
U.S.C. 299b-23(b), AHRQ coordinates the development of the Common
Formats that facilitate aggregation of comparable data at local, PSO,
regional and national levels. The Common Formats allow PSOs and health
care providers to voluntarily collect and submit standardized
information regarding patient safety events to fulfill the national
learning system envisioned by the Patient Safety Act.
OMB previously approved the Common Formats and forms described
above in 2008, 2011, 2014, and 2018. AHRQ will use these forms, other
than the Patient Safety Confidentiality Complaint Form, to obtain
information necessary to carry out its authority to implement the
Patient Safety Act and Patient Safety Rule. This includes obtaining
initial and subsequent certifications from entities seeking to be or
remain listed as PSOs and for making the statutorily required
determinations prior to and during an entity's period of listing as a
PSO. The PSO Division, housed in AHRQ's Center for Quality Improvement
and Patient Safety, uses this information.
OCR will use the Patient Safety Confidentiality Complaint Form to
collect information for the initial assessment of an incoming
complaint. The form is modeled on OCR's form for complaints alleging
violations of the privacy of protected health information. Use of the
form is voluntary. It may help a complainant provide the essential
information. Alternatively, a complainant may choose to submit a
complaint in the form of a letter or electronically. An individual who
needs help to submit a complaint in writing may call OCR for
assistance.

[[Page 41038]]

Estimated Annual Respondent Burden

The PSO information collection forms described below will be
implemented at different times and frequencies due to the voluntary
nature of seeking listing and remaining listed as a PSO, filing an OCR
Patient Safety Confidentiality Complaint Form, and using the Common
Formats. For the PSO forms, the burden estimates are based on the
average of submissions received over the past three years. For the
Common Formats, this estimate is based on the feedback that AHRQ has
received during meetings and technical assistance calls from PSOs and
other entities that have been utilizing the formats.
Exhibit 1 shows the estimated annualized burden hours for the
respondent to provide the requested information, and Exhibit 2 shows
the estimated annualized cost burden associated with the respondents'
time to provide the requested information. The total burden hours are
estimated to be 100,795.83 hours annually and the total cost burden is
estimated to be $4,053,000.33 annually.
PSO Certification for Initial Listing Form: The average annual
burden for the collection of information requested by the certification
forms for initial listing is based upon a total average estimate of 10
respondents per year and an estimated time of 18 hours per response.
The estimated response number includes submissions by not only entities
listed as PSOs, but also entities that submit initial listing forms
that do not become PSOs. After submitting a PSO Certification for
Initial Listing Form, an entity may withdraw its form or submit a
revised form, particularly after receiving technical assistance from
AHRQ. In addition, AHRQ, on behalf of the Secretary, may deny listing
if an entity does not meet the requirements of the Patient Safety Act
and Patient Safety Rule.
PSO Certification for Continued Listing Form: The average annual
burden for the collection of information requested by the certification
form for continued listing has an estimated time of eight hours per
response and 42 responses annually. The PSO Certification for Continued
Listing Form must be submitted by any interested PSO at least 75 days
before the end of its current three-year listing period.
PSO Two Bona Fide Contracts Requirement Certification Form: The
average annual burden for the collection of information requested by
the PSO Two Bona Fide Contract Certification Form is based upon an
estimate of 51 respondents per year and an estimated one hour per
response. This collection of information takes place when the PSO
notifies the Secretary that it has entered into two contracts with
providers, which is required once every 24 months.
PSO Disclosure Statement Form: The overall annual burden for the
collection of information requested by the PSO Disclosure Statement
Form is based upon an estimate of two respondents per year and
estimated three hours per response. This information collection takes
place when a PSO first reports having any of the specified types of
additional relationships with a provider with which it has a contract
to carry out patient safety activities.
PSO Profile Form: The overall annual burden for the collection of
information requested by the PSO Profile Form is based upon an estimate
of 72 respondents per year and an estimated three hours per response.
The collection of information takes place annually with newly listed
PSOs first eligible to submit the form in the calendar year after their
initial listing by the Secretary.
PSO Change of Listing Information Form: The average annual burden
for the collection of information requested by the PSO Change of
Listing Information Form is based upon an estimate of 54 respondents
per year and an estimated time of five minutes per response. This
collection of information takes place on an ongoing basis as needed
when there are changes to the PSO's listing information.
OCR Patient Safety Confidentiality Complaint Form: The overall
annual burden estimate of one hour for the collection of information
requested by the form is based on an estimate of one respondent per
year and an estimated twenty minutes per response.
PSO Voluntary Relinquishment Form: The average annual burden for
the collection of information requested by the PSO Voluntary
Relinquishment Form is based upon a total average estimate of four
respondents per year and an estimated time of thirty minutes per
response.
Common Formats: AHRQ estimates that 5% FTE of a patient safety
manager at a facility will be spent to administer the Common Formats,
which is approximately 100 hours a year. The use of the formats by PSOs
and other entities is voluntary and is on an ongoing basis.

Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form Number of responses per Hours per Total burden
respondents respondent response hours
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PSO Certification for Initial Listing Form...... 10 1 18 180
PSO Certification for Continued Listing Form.... 42 1 8 336
PSO Two Bona Fide Contracts Requirement Form.... 51 1 1 51
PSO Disclosure Statement Form................... 2 1 3 6
PSO Profile Form................................ 72 1 3 216
PSO Change of Listing Information............... 54 1 05/60 4.50
PSO Voluntary Relinquishment Form............... 4 1 30/60 2
OCR Patient Safety Confidentiality Complaint 1 1 20/60 .33
Form...........................................
Common Formats.................................. 1,000 1 100 100,000
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Total....................................... .............. NA NA 100,795.83
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Exhibit 2--Estimated Annualized Cost Burden
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Average
Form Number of Total burden hourly wage Total cost
respondents hours rate \*\
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PSO Certification for Initial Listing Form...... 10 180 $40.21 $7,237.80

[[Page 41039]]

PSO Certification for Continued Listing Form.... 42 336 40.21 13,510.56
PSO Two Bona Fide Contracts Requirement Form.... 451 451 40.21 2,050.71
PSO Disclosure Statement Form................... 2 6 40.21 241.26
PSO Profile Form................................ 72 216 40.21 8,685.36
PSO Change of Listing Form...................... 54 4.50 40.21 180.95
PSO Voluntary Relinquishment Form............... 4 2 40.21 80.42
OCR Patient Safety Confidentiality Complaint 1 .33 40.21 13.27
Form...........................................
Common Formats.................................. 1,000 100,000 40.21 4,021,000.00
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Total....................................... .............. .............. .............. 4,053,000.33
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\*\ Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29-
0000, National Compensation Survey, May 2019, ``U.S. Department of Labor, Bureau of Labor Statistics.'' <a href="https://www.bls.gov/oes/current/oes290000.htm">https://www.bls.gov/oes/current/oes290000.htm</a>.

Request for Comments

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, comments on AHRQ's information collection are requested with
regard to any of the following: (a) Whether the proposed collection of
information is necessary for the proper performance of AHRQ's health
care research and health care information dissemination functions,
including whether the information will have practical utility; (b) the
accuracy of AHRQ's estimate of burden (including hours and costs) of
the proposed collection(s) of information; (c) ways to enhance the
quality, utility and clarity of the information to be collected; and
(d) ways to minimize the burden of the collection of information upon
the respondents, including the use of automated collection techniques
or other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.

Dated: July 27, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-16326 Filed 7-29-21; 8:45 am]
BILLING CODE 4160-90-P

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