Federal Register Notice

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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Number of
respondents

Form name
Team Checkup Tool (Attachment J) (1 checklist conducted monthly per facility during 18 months of intervention for LTC cohort, 300 facilities total)

Total burden
hours

100

Average
hourly wage
rate

Total cost
burden

306

* 51.53

15,768.18

267

2,403

— 35.17

84,513.51

100

50

— 35.17

1,758.50

100

500

— 35.17

17,585.00

367

1,101

— 35.17

38,722.17

100

900

— 35.17

31,653.00

13,535

13,151

........................

596,597.83

Electronic Health Record (EHR) Extracts
Initial data pull (Attachment P)—(once at baseline for ICU and non-ICU cohorts, 800 units total) ...................................................................................
Initial data pull (Attachment Q)—(once at baseline for Surgical cohort, 300
settings total) ................................................................................................
Initial data pull (Attachment R)—(once at baseline for LTC cohort, 300 facilities total) .......................................................................................................
Quarterly data (Attachments P and Q)—(quarterly during 18 months of
intervention for ICU, non-ICU, and Surgical cohorts, 1,100 units total) ......
Monthly data (Attachment R)—(monthly per facility during 18 months of
intervention for LTC cohort, 100 facilities total) ...........................................
Total ..........................................................................................................

* This is an average of the average hourly wage rate for physician, nurse, nurse practitioner, physician’s assistant, and nurse’s aide from the
May 2019 National Occupational Employment and Wage Estimates, United States, U.S. Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).
¥ This is an average of the average hourly wage rate for nurse and IT specialist from the May 2019 National Occupational Employment and
Wage Estimates, United States, U.S. Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).

Request for Comments

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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: April 27, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–09138 Filed 4–30–21; 8:45 am]
BILLING CODE 4160–90–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, HHS.

AGENCY:
ACTION:

Notice

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the renewal of
the information collection project
‘‘Medical Office Survey on Patient
Safety Culture Database.’’

SUMMARY:

Comments on this notice must be
received by July 2, 2021

DATES:

Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.

ADDRESSES:

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:

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Proposed Project
Medical Office Survey on Patient Safety
Culture Database
In 1999, the Institute of Medicine
called for health care organizations to
develop a ‘‘culture of safety’’ such that
their workforce and processes focus on
improving the reliability and safety of
care for patients (IOM, 1999; To Err is
Human: Building a Safer Health
System). To respond to the need for
tools to assess patient safety culture in
health care, AHRQ developed and pilot
tested the Medical Office Survey on
Patient Safety Culture with OMB
approval (OMB NO.0935–0131;
Approved July 5, 2007).
The survey is designed to enable
medical offices to assess provider and
staff perspectives about patient safety
issues, medical error, and error
reporting. The survey includes 38 items
that measure 10 composites of patient
safety culture. In addition to the
composite items, 14 items measure staff
perceptions how often medical offices
have problems exchanging information
with other settings as well as other
patient safety and quality issues. AHRQ
made the survey publicly available
along with a Survey User’s Guide and
other toolkit materials in December
2008 on the AHRQ website.
The AHRQ Medical Office SOPS
Database consists of data from the
AHRQ Medical Office Survey on Patient
Safety Culture and may include
reportable, non-required supplemental
items. Medical offices in the U.S. can
voluntarily submit data from the survey
to AHRQ, through its contractor, Westat.

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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices

The Medical Office SOPS Database
(OMB NO. 0935–0196, last approved on
September 10, 2018) was developed by
AHRQ in 2011 in response to requests
from medical offices interested in
tracking their own survey results. Those
organizations submitting data receive a
feedback report, as well as a report of
the aggregated, de-identified findings of
the other medical offices submitting
data. These reports are used to assist
medical office staff in their efforts to
improve patient safety culture in their
organizations.
Rationale for the information
collection. The Medical Office SOPS
and the Medical Office SOPS Database
support AHRQ’s goals of promoting
improvements in the quality and safety
of health care in medical office settings.
The survey, toolkit materials, and
database results are all made publicly
available on AHRQ’s website. Technical
assistance is provided by AHRQ through
its contractor at no charge to medical
offices, to facilitate the use of these
materials for medical office patient
safety and quality improvement.
Request for information collection
approval. AHRQ requests that OMB
reapprove, under the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ’s collection of information for
the AHRQ Medical Office SOPS
Database; OMB NO. 0935–0196, last
approved on September 10, 2018.
This database:
(1) Presents results from medical
offices that voluntarily submit their
data,
(2) Provides data to medical offices to
facilitate internal assessment and
learning in the patient safety
improvement process, and
(3) Provides supplemental
information to help medical offices
identify their strengths and areas with
potential for improvement in patient
safety culture.
This study is being conducted by
AHRQ through its contractor, Westat,
pursuant to AHRQ’s statutory authority
to conduct and support research on

healthcare and on systems for the
delivery of such care, including
activities with respect to: The quality,
effectiveness, efficiency,
appropriateness and value of healthcare
services; quality measurement and
improvement; and database
development. 42 U.S.C. 299a(a)(1), (2),
and (8).
Method of Collection
To achieve the goal of this project the
following activities and data collections
will be implemented:
(1) Eligibility and Registration Form—
The medical office point-of-contact
(POC) completes a number of data
submission steps and forms, beginning
with the completion of an online
Eligibility and Registration Form. The
purpose of this form is to collect basic
demographic information about the
medical office and initiate the
registration process.
(2) Data Use Agreement—The
purpose of the data use agreement,
completed by the medical office POC, is
to state how data submitted by medical
offices will be used and provides
privacy assurances.
(3) Medical Office Site Information
Form—The purpose of the site
information form also completed by the
medical office POC, is to collect
background characteristics of the
medical office. This information will be
used to analyze data collected with
Medical Office SOPS survey.
(4) Data Files Submission—POCs
upload their data file(s), using the
medical office data file specifications, to
ensure that users submit standardized
and consistent data in the way variables
are named, coded, and formatted. The
number of submissions to the database
is likely to vary each year because
medical offices do not administer the
survey and submit data every year. Data
submission is typically handled by one
POC who is either an office manager or
a survey vendor who contracts with a
medical office to collect their data.
POCs submit data on behalf of 20

medical offices, on average, because
many medical offices are part of a health
system that includes many medical
office sites, or the POC is a vendor that
is submitting data for multiple medical
offices.
Survey data from the AHRQ Medical
Office Survey on Patient Safety Culture
are used to produce three types of
products:
(1) A Medical Office SOPS Database
Report that is made publicly available
on the AHRQ website; and
(2) Individual Medical Office Survey
Feedback Reports that are customized
for each medical office that submits data
to the database; and
(3) Research data sets of individuallevel and medical office-level deidentified data to enable researchers to
conduct analyses. All data released in a
data set are de-identified at the
individual-level and the medical officelevel.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in the
database. An estimated 85 POCs, each
representing an average of 20 individual
medical offices each, will complete the
database submission steps and forms.
Each POC will submit the following:
• Eligibility and registration form
(completion is estimated to take about 3
minutes).
• Data Use Agreement (completion is
estimated to take about 3 minutes).
• Medical Office Information Form
(completion is estimated to take about 5
minutes).
• Survey data submission will take an
average of one hour.
The total burden is estimated to be
341.5 hours.
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.
The cost burden is estimated to be
$17,854 annually.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs

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Form name

Number of
responses
per POC

Hours per
response

Total burden
hours

Eligibility/Registration Form .............................................................................
Data Use Agreement .......................................................................................
Medical Office Information Form .....................................................................
Data Files Submission .....................................................................................

85
85
85
85

1
1
35
1

3/60
3/60
5/60
1

4.25
4.25
248
85

Total ..........................................................................................................

NA

NA

NA

341.5

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Federal Register / Vol. 86, No. 83 / Monday, May 3, 2021 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents/
POCs

Form name

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

Registration Form ............................................................................................
Data Use Agreement .......................................................................................
Medical Office Information Form .....................................................................
Data Files Submission .....................................................................................

85
85
85
85

4.25
4.25
248
85

$52.28
52.28
52.28
52.28

$222
222
12,965
4,444

Total ..........................................................................................................

NA

341.5

NA

17,854

* Mean hourly wage rate of $52.28 for Medical and Health Services Managers (SOC code 11–9111) was obtained from the May 2019 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at https://www.bls.gov/
oes/current/naics4_621100.htm.

Request for Comments
In accordance with the Paperwork
Reduction Act, 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: April 27, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021–09139 Filed 4–30–21; 8:45 am]
BILLING CODE 4160–90–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality

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Patient Safety Organizations:
Voluntary Relinquishment for the
Sigma PSO, LLC
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of Delisting.
AGENCY:

The Patient Safety and
Quality Improvement Final Rule

SUMMARY:

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(Patient Safety Rule) authorizes AHRQ,
on behalf of the Secretary of HHS, to list
as a patient safety organization (PSO) an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety and Quality Improvement Act of
2005 (Patient Safety Act) and Patient
Safety Rule, when a PSO chooses to
voluntarily relinquish its status as a
PSO for any reason, or when a PSO’s
listing expires. AHRQ accepted a
notification of proposed voluntary
relinquishment from the Sigma PSO,
LLC, PSO number P0190, of its status as
a PSO, and has delisted the PSO
accordingly.
The delisting was effective at
12:00 Midnight ET (2400) on April 1,
2021.

DATES:

The directories for both
listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. Both
directories can be accessed
electronically at the following HHS
website: http://www.pso.ahrq.gov/listed.
FOR FURTHER INFORMATION CONTACT:
Cathryn Bach, Center for Quality
Improvement and Patient Safety, AHRQ,
5600 Fishers Lane, MS 06N100B,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: pso@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:

Background
The Patient Safety Act, 42 U.S.C.
299b–21 to 299b–26, and the related
Patient Safety Rule, 42 CFR part 3,
published in the Federal Register on
November 21, 2008 (73 FR 70732–
70814), establish a framework by which
individuals and entities that meet the
definition of provider in the Patient
Safety Rule may voluntarily report
information to PSOs listed by AHRQ, on
a privileged and confidential basis, for

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the aggregation and analysis of patient
safety events.
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
PSOs.
AHRQ has accepted a notification of
proposed voluntary relinquishment
from the Sigma PSO, LLC to voluntarily
relinquish its status as a PSO.
Accordingly, the Sigma PSO, LLC,
P0190, was delisted effective at 12:00
Midnight ET (2400) on April 1, 2021.
Sigma PSO, LLC has patient safety
work product (PSWP) in its possession.
The PSO will meet the requirements of
section 3.108(c)(2)(i) of the Patient
Safety Rule regarding notification to
providers that have reported to the PSO
and of section 3.108(c)(2)(ii) regarding
disposition of PSWP consistent with
section 3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO has 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at http://www.pso.ahrq.gov.

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