Agency Information Collection Activities: Proposed Collection; Comment Request, 41036-41039 [2021-16326]
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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices
• Information gathered will be used
only internally for general service
improvement and program management
purposes and is not intended for release
to the public;
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions;
and
• Information gathered will yield
qualitative information; the collections
will not be designed or expected to
yield statistically reliable results or used
as though the results are generalizable to
the population of study.
Feedback collected under this generic
clearance provides useful information,
but it does not yield data that can be
generalized to the overall population.
This type of generic clearance for
qualitative information will not be used
for quantitative information collections
that are designed to yield reliably
actionable results, such as monitoring
trends over time or documenting
program performance. Such data uses
require more rigorous designs that
address: The target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior to
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
As a general matter, information
collections submitted under this generic
clearance will not result in any new
system of records containing privacy
information and will not ask questions
of a sensitive nature, such as sexual
behavior and attitudes, religious beliefs,
and other matters that are commonly
considered private.
A Federal Register Notice with a 60day comment period soliciting
comments on this information
collection was published on May 19,
2021 (86 FR 27088). OGE did not
receive any comments in response.
OMB Number: 3209–0010.
Type of Request: Extension.
Affected Public: Individuals; Business
or Other For-Profit Institutions; Not-ForProfit Institutions; State, Local, or Tribal
Government.
Projected average burden estimates
for the next three years:
Estimated Annual Number of
Respondents: 91,425.
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Average Expected Annual Number of
Activities: 39.
Average Number of Respondents per
Activity: 2,344.
Responses per Respondent: 1.
Annual Responses: 91,425.
Average Minutes per Response: 3
minutes.
Annual Burden Hours: 3,900 hours.
Frequency: On occasion.
Request for Comments: Agency and
public comment is invited specifically
on the need for and practical utility of
this information collection, the accuracy
of OGE’s burden estimate, the
enhancement of quality, utility and
clarity of the information collected, and
the minimization of burden (including
the use of information technology).
Comments will become a matter of
public record.
Approved: July 26, 2021.
Emory Rounds,
Director, U.S. Office of Government Ethics.
[FR Doc. 2021–16221 Filed 7–29–21; 8:45 am]
BILLING CODE 6345–03–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality (AHRQ), Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
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
SUMMARY:
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notice to www.reginfo.gov/public/do/
PRAMain. 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 doris.lefkowitz@AHRQ.hhs.gov.
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
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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices
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.
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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 abovecited 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.
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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 ‘‘AHRQlisted’’ 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
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41037
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.
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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
Number of
respondents
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Form
Number of
responses
per
respondent
Hours per
response
Total
burden hours
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 Information .................................................................
PSO Voluntary Relinquishment Form ..............................................................
OCR Patient Safety Confidentiality Complaint Form .......................................
Common Formats ............................................................................................
10
42
51
2
72
54
4
1
1,000
1
1
1
1
1
1
1
1
1
18
8
1
3
3
05/60
30/60
20/60
100
180
336
51
6
216
4.50
2
.33
100,000
Total ..........................................................................................................
........................
NA
NA
100,795.83
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form
PSO Certification for Initial Listing Form .........................................................
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Total
burden hours
10
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180
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Average
hourly
wage rate *
$40.21
Total cost
$7,237.80
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Federal Register / Vol. 86, No. 144 / Friday, July 30, 2021 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents
Form
Total
burden hours
Average
hourly
wage rate *
Total cost
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 ..........................................................................
PSO Voluntary Relinquishment Form ..............................................................
OCR Patient Safety Confidentiality Complaint Form .......................................
Common Formats ............................................................................................
42
451
2
72
54
4
1
1,000
336
451
6
216
4.50
2
.33
100,000
40.21
40.21
40.21
40.21
40.21
40.21
40.21
40.21
13,510.56
2,050.71
241.26
8,685.36
180.95
80.42
13.27
4,021,000.00
Total ..........................................................................................................
........................
........................
........................
4,053,000.33
* 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.’’ https://www.bls.gov/oes/current/oes290000.htm.
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]
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BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10398 #72]
Medicaid and Children’s Health
Insurance Program (CHIP) Generic
Information Collection Activities:
Proposed Collection; Comment
Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
On May 28, 2010, the Office
of Management and Budget (OMB)
issued Paperwork Reduction Act (PRA)
guidance 1 related to the ‘‘generic’’
clearance process. Generally, this is an
expedited process by which agencies
may obtain OMB’s approval of
collection of information requests that
are ‘‘usually voluntary, low-burden, and
uncontroversial collections,’’ do not
raise any substantive or policy issues,
and do not require policy or
methodological review. The process
requires the submission of an
overarching plan that defines the scope
of the individual collections that would
fall under its umbrella. On October 23,
2011, OMB approved our initial request
to use the generic clearance process
under control number 0938–1148
(CMS–10398). It was last approved on
April 26, 2021, via the standard PRA
process which included the publication
of 60- and 30-day Federal Register
notices. The scope of the April 2021
umbrella accounts for Medicaid and
CHIP State plan amendments, waivers,
demonstrations, and reporting. This
Federal Register notice seeks public
SUMMARY:
1 https://www.whitehouse.gov/sites/
whitehouse.gov/files/omb/assets/inforeg/PRA_Gen_
ICRs_5-28-2010.pdf.
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comment on one or more of our
collection of information requests that
we believe are generic and fall within
the scope of the umbrella. Interested
persons are invited to submit comments
regarding our burden estimates or any
other aspect of this collection of
information, including: The necessity
and utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
DATES: Comments must be received by
August 13, 2021.
ADDRESSES: When commenting, please
reference the applicable form number
(see below) and the OMB control
number (0938–1148). To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may access CMS’
website at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
Following
is a summary of the use and burden
associated with the subject information
collection(s). More detailed information
SUPPLEMENTARY INFORMATION:
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Agencies
[Federal Register Volume 86, Number 144 (Friday, July 30, 2021)]
[Notices]
[Pages 41036-41039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.
-----------------------------------------------------------------------
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 www.reginfo.gov/public/do/PRAMain. 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
[email protected].
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
----------------------------------------------------------------------------------------------------------------
Number of
Form Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------
Total....................................... .............. NA NA 100,795.83
----------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form Number of Total burden hourly wage Total cost
respondents hours rate \*\
----------------------------------------------------------------------------------------------------------------
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
---------------------------------------------------------------
Total....................................... .............. .............. .............. 4,053,000.33
----------------------------------------------------------------------------------------------------------------
\*\ 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.'' https://www.bls.gov/oes/current/oes290000.htm.
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