Agency Information Collection Activities: Proposed Collection; Comment Request, 40414-40417 [2019-17398]
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
process. In addition, the Federal Travel
Regulation (FTR) allows for actual
expense reimbursement as provided in
§§ 301–11.300 through 301–11.306.
For FY 2020, one new non-standard
area (NSA) location was added for
Boise, Idaho (Ada County). In addition,
Park County, Montana was added to the
Big Sky, Montana NSA area. In
Montana, Missoula and Flathead
Counties were separated into their own
NSAs instead of a combined NSA. The
standard CONUS lodging rate will
increase from $94 to $96. The M&IE
reimbursement rate tiers were
unchanged for FY 2020. The standard
CONUS M&IE rate remains at $55, and
the M&IE NSA tiers remain at $56–$76.
GSA issues and publishes the CONUS
per diem rates, formerly published in
Appendix A to 41 CFR Chapter 301,
solely on the internet at www.gsa.gov/
perdiem. GSA also has removed and
now solely publishes the M&IE
deduction table from Appendix B to 41
CFR Chapter 301, which is used when
employees are required to deduct meals
from their M&IE reimbursement
pursuant to FTR § 301–11.18, at
www.gsa.gov/mie. This process,
implemented in 2003, for per diem
reimbursement rates and in 2015
(internet publication) and 2018 (removal
from the FTR) for the M&IE deduction
table, ensures more timely changes in
per diem reimbursement rates
established by GSA for Federal
employees on official travel within
CONUS.
Notices published periodically in the
Federal Register now constitute the
only notification of revisions in CONUS
per diem reimbursement rates to
agencies other than the changes posted
on the GSA website.
Jessica Salmoiraghi,
Associate Administrator, Office of
Government-wide Policy.
[FR Doc. 2019–17416 Filed 8–13–19; 8:45 am]
BILLING CODE 6820–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jspears on DSK3GMQ082PROD with NOTICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
SUMMARY:
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that the Office of Management and
Budget (OMB) approve the proposed
information collection project: ‘‘Safety
Program in Perinatal Care (SPPC)—II
Demonstration Project.’’
This proposed information collection
was previously published in the Federal
Register on May 1, 2019, and allowed
60 days for public comment. AHRQ
received no substantive comments. The
purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by date 30 days after date of
publication.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk
officer).
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
Safety Program in Perinatal Care
(SPPC)—II Demonstration Project
Maternal mortality and severe
maternal morbidity (SMM) increased
significantly and continuously in the
United States (US) over the past 30
years. A considerable proportion of
these adverse events are attributable to
preventable harm and unintended
consequences arising from clinical
practice and the system of delivering
perinatal care. To address these
alarming trends, AHRQ has developed
the Safety Program in Perinatal Care
(SPPC). During its initial phase (SPPC–
I), the program was comprised of three
pillars: Teamwork and communication,
patient safety bundles, and in situ
simulations. Despite several promising
results, the evaluation of SPPC–I
revealed considerable hospital attrition
due to heavy data burden and
competing safety initiatives. Also,
differences in the local adaptation of the
SPPC–I patient safety bundles selected
by implementation sites thwarted a
meaningful cross-site comparison of
programmatic impact.
The current, second phase of the
program (SPPC–II), focuses on
integrating the teamwork and
communication pillar into patient safety
bundles developed by key professional
organizations and implemented in 20+
US states with technical assistance by
the Alliance for Innovation on Maternal
Health (AIM) program and funding from
the Health Resources and Services
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Administration (HRSA). Of note, the
model used by AIM to implement these
bundles is through statewide perinatal
quality collaboratives (PQC) aiming to
enroll all birthing hospitals in the state
in the PQC.
During the Planning Phase of SPPC–
II, the contractor, Johns Hopkins
University (JHU), developed SPPC–II
Training Toolkits for two AIM patient
safety bundles: Obstetric hemorrhage
and severe hypertension in pregnancy.
The aim of the SPPC–II Demonstration
Project is to implement and evaluate an
integrated AIM–SPPC II program that
overlays the SPPC–II Training Toolkits
and the AIM patient safety bundles and
program infrastructure in two states—
Oklahoma (OK), currently implementing
the severe hypertension bundle; and
Texas (TX), currently implementing the
hemorrhage bundle.
Over the next five years, the AIM
program is expected to cover about two
thirds of US states. Therefore, there is
need to determine the feasibility and
impact of the proposed integrated AIM–
SPPC II program, and inform future
government funding decisions regarding
these two programs.
To this end, the SPPC–II
Demonstration Project has the following
goals:
(1) To implement the integrated AIM–
SPPC II program in birthing hospitals in
OK and TX in coordination with AIM
and the respective state PQC;
(2) To assess the implementation of
the integrated AIM–SPPC II program in
these hospitals; and
(3) To ascertain the short- and
medium-term impact of the integrated
AIM–SPPC II program on hospital (i.e.,
perinatal unit) teamwork and
communication, patient safety, and key
maternal health outcomes.
This study is being conducted by
AHRQ through its contractor, Johns
Hopkins University (JHU) and the AIM
program, JHU’s subcontractor, 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 and with respect to quality
measurement and improvement. 42
U.S.C. 299a (a)(1) and (2).
Method of Collection
To achieve the goals of this project the
following data collections will be
implemented:
(a) Training of AIM Team Leads from
48 birthing hospitals in OK and 210
birthing hospitals in TX (i.e., all birthing
hospitals enrolled in the respective state
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PQC) on using teamwork and
communication tools and strategies in
clinical obstetric practice. The training
will be conducted in-person, through a
full-day workshop organized in
collaboration and coordination with the
AIM program and state PQCs, and led
by JHU. Only one such training
workshop will be conducted in OK
using the SPPC–II Toolkit for severe
hypertension in pregnancy. Given the
size of the state, potential long distances
to be traveled by trainees, and the costefficiency of coordinating with back-toback regional PQC meetings planned in
TX this fall, five training workshops
will be conducted in this state using the
SPPC–II Toolkit for obstetric
hemorrhage. We expect about half of the
birthing hospitals in both states to send
2 hospital champions, of which one to
be designated as AIM Team Lead, for
training. JHU will keep and bi-annually
update a roster of AIM Team Leads in
each hospital to assess the need for
training of new AIM Team Leads if
turnover occurs. Training workshop
evaluation forms will be distributed for
completion by trainees on a voluntary
basis to assess the perceived utility of
training workshops.
(b) Training of all frontline clinical
staff in 48 birthing hospitals in OK and
210 birthing hospitals in TX on
teamwork and communication tools and
strategies will be coordinated by AIM
Team Leads in each hospital by: (a)
Providing unique trainee IDs and
information for them to access 8 training
e-modules online (with option to leave
voluntary comments/suggestions), and
(b) using the JHU-developed facilitator
guide included in the SPPC–II Toolkits
to facilitate brief, in-person
demonstration sessions on how to use
the information from the training emodules in clinical practice. Each of the
eight training e-modules will take about
15 minutes to complete online, for a
total of about 120 minutes. Because
these training e-modules will be
accessed and completed online, tracking
of e-module completion and re-take,
needed to assess overall staff exposure
to training, is possible through the
online training platform.
(c) Coaching calls will be organized
monthly and led by JHU to address
program implementation questions and
assist with potential challenges. AIM
Team Leads in all Demonstration
Project hospitals will be invited to join
these calls and ask questions. A list of
coaching call participants and topics
addressed will be maintained by JHU.
(d) AIM Team Lead self-administered
baseline surveys will be made available
2–3 weeks before the AIM Team Leads
training workshop, together with a
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corresponding consent form. The
purpose of this survey is to assess key
characteristics of project hospitals,
including human resources, processes
in place for AIM bundle
implementation, and use of teamwork
and communication tools in clinical
practice. Respondents will have the
option to complete the survey online or
on paper, in line with the current
administration of the Hospital Survey
on Patient Safety Culture. The expected
response rate for this survey is 95% in
both states.
(e) Clinical staff self-administered
baseline surveys will be made available
before the first training workshop with
AIM Team Leads, together with a
corresponding consent form. The
purpose of this survey is to assess
baseline levels of previous teamwork
and communication training, overall use
of teamwork and communication tools
and strategies, teamwork and
communication perceptions, experience
with AIM bundle implementation.
Three respondents will be randomly
selected in each hospital using
comprehensive lists of clinical staff
developed by the AIM Team Leads.
These lists will be updated by AIM
Team Leads on a quarterly basis to
capture new hires and staff turnover.
Respondents will be given the option to
complete the survey online or on paper,
in line with the administration of the
national Hospital Survey on Patient
Safety Culture. The expected response
rate for this survey is 85% in both
states.
(f) Qualitative, semi-structured
interviews with AIM Team Leads will be
conducted by phone about 3–4 months
after their training workshop to assess
the perceived utility of the training and
assistance needed with the rollout of
training to all frontline clinical staff
using the e-modules and facilitation
sessions to consolidate the information.
An interview guide developed based on
the Consolidated Framework for
Implementation Research framework
will be used to conduct the interviews,
together with a corresponding consent
form.
(g) Clinical staff self-administered
implementation surveys will be made
available at about 6, 18, and 30 months
after the first AIM Team Leads training,
together with a corresponding consent
forms, to assess training knowledge,
transfer, and results such as use of
teamwork and communication tools and
strategies, teamwork and
communication perceptions, experience
with AIM bundle implementation
overlaid with the teamwork and
communication tools. The time points
were chosen to assess: Early adoption
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and results of the training (6-month
survey); adoption and results of the
training at the time when unit culture
changes are expected per available
implementation research (18-month
survey); and medium-term program
sustainability (30-month survey). For
each survey, three respondents will be
randomly selected in each hospital
using the most up to date
comprehensive lists of clinical staff
developed by the AIM Team Leads.
Respondents will have the option to
complete these surveys online or on
paper, in line with the administration of
the national Hospital Survey on Patient
Safety Culture. The expected response
rates are 80%, 77.5% and 75% for
surveys completed at 6, 18 and 30
months after AIM Team Leads training
workshops, respectively.
(h) AIM program data will be obtained
from the AIM program, a subcontractor
of JHU’s, under data use agreements
with coordinating bodies of state PQCs
in the fall of 2019. These data are
needed for the evaluation of the SPPC–
II Demonstration Project to assess
changes in key AIM program processes
and maternal health outcomes, such as
severe maternal morbidity, throughout
the project.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden ours for the
respondents’ time to participate in the
SPPC–II Demonstration Project.
An estimated 387 AIM Team Leads
from the 258 Demonstration Project sites
will be trained during 8-hour workshops
using the SPPC–II Toolkit. An
evaluation form, which will take
approximately 5 minutes to complete,
will be distributed to them at the end of
the workshop, and about 75% of them
(290 AIM Team Leads) are expected to
complete the evaluation. They will also
be asked to extract from an available
human resources computerized database
and update bi-annually rosters of
frontline clinical staff in their units—
first extraction and each update is
expected to take about 5 minutes.
An estimated 15,480 frontline clinical
staff are expected to be trained using the
training e-modules in the SPPC–II
Toolkit. Completion of the 8 e-modules
will take about 2 hours. These trainings
will be complemented by four 15-min
facilitation sessions led by AIM Team
Leads in their respective units. The AIM
Team Leads will track attendance of the
facilitation session, work estimated to
take about 15 minutes after each
session.
Monthly 1-hour coaching calls will be
organized during the first 18 months of
the project and at least one
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representative from about half of the
sites is expected to participate at each
coaching call.
Several surveys will be administered
throughout the Demonstration Project,
specifically: Baseline, 20-minute
surveys with AIM Team Leads at each
of 258 sites; baseline, 25-minute surveys
with 3 randomly selected frontline
clinical staff at each of 258 sites; 30minute implementation surveys with 3
randomly selected frontline clinical staff
at each of 258 sites will be conducted
at 6, 18, and 30 months after the initial
training workshops in both states. In
addition, one-hour qualitative
interviews will be conducted with 25
AIM Team Leads in the 2 states about
3–4 months after the initial training
workshops in their respective state.
We will inform AIM Team Leads of
the DUAs put in place to access AIM
data—this will take about 5 minutes.
The total annual burden hours are
estimated to be 54,654 hours.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Training of AIM Team Leads ...........................................................................
Frontline staff rosters developed by AIM Team Leads ...................................
Evaluation form for training of AIM Team Leads ............................................
Training of frontline clinical staff ......................................................................
Facilitation sessions .........................................................................................
Tracking attendance of facilitation sessions ....................................................
Coaching calls .................................................................................................
Self-administered baseline surveys with AIM Team Leads ............................
Self-administered baseline surveys with clinical staff .....................................
Qualitative semi-structured interviews with AIM Team Leads ........................
Self-administered implementation surveys with clinical staff at 6 months ......
Self-administered implementation surveys with clinical staff at 18 months ....
Self-administered implementation surveys with clinical staff at 30 months ....
DUA for AIM data ............................................................................................
387
258
290
15,480
15,480
258
129
258
774
25
774
774
774
258
1
6
1
1
4
4
18
1
1
1
1
1
1
1
8
0.08
0.08
2.00
0.25
1.00
1.00
0.33
0.42
1.00
0.50
0.50
0.50
0.08
3,096
124
23
30,960
15,480
1,032
2,322
85
325
25
387
387
387
21
Total ..........................................................................................................
36,048
NA
NA
54,654
Exhibit 2 shows the estimated
annualized cost burden based on the
respondents’ time to submit their data.
The cost burden is estimated to be
$1,489,998.34 annually.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Total burden
hours
Average
hourly wage
rate *
Total cost
burden
Training of AIM Team Leads ...........................................................................
Frontline staff rosters developed by AIM Team Leads ...................................
Evaluation form for training of AIM Team Leads ............................................
Training of frontline clinical staff ......................................................................
Facilitation sessions .........................................................................................
Tracking attendance of facilitation sessions ....................................................
Coaching calls .................................................................................................
Self-administered baseline surveys with AIM Team Leads ............................
Self-administered baseline surveys with clinical staff .....................................
Qualitative semi-structured interviews with AIM Team Leads ........................
Self-administered implementation surveys with clinical staff at 6 months ......
Self-administered implementation surveys with clinical staff at 18 months ....
Self-administered implementation surveys with clinical staff at 30 months ....
DUA for AIM data ............................................................................................
387
258
290
15,480
15,480
258
129
258
774
25
774
774
774
258
3,096
124
23
30,960
15,480
1,032
2,322
85
325
25
387
387
387
21
$49.83
49.83
49.83
66.32
66.32
49.83
66.32
49.83
66.32
49.83
66.32
66.32
66.32
49.83
$154,273.68
6,178.92
1,146.09
2,053,267.20
1,026,633.60
51,424.56
153,995.04
4,235.55
21,554
1,245.75
25,665.84
25,665.84
25,665.84
1,046.43
Total ..........................................................................................................
36,048
54,716
........................
1,489,998.34
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* National Compensation Survey: Occupational wages in the United States May 2017 ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Hourly wage for nurse-midwives ($48.36; occupation code 29–1161).
b Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29–1064; 30%); nurse-midwives ($49.83; occupation
code 29–1161; 30%); registered nurses ($35.36; occupation code 29–1161; 20%); and nurse practitioners ($51.86; occupation code 29–1171;
20%).
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
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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
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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
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Notices
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: August 8, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019–17398 Filed 8–13–19; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2374]
Drugs Intended for Human Use That
Are Improperly Listed Due to Lack of
Annual Certification or Identification of
a Manufacturing Establishment Not
Duly Registered With the Food and
Drug Administration; Action Dates
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of intent.
The Food and Drug
Administration (FDA or Agency) is
announcing its intention to begin
inactivating drug listing records that are
improperly listed in accordance with
FDA requirements because these drug
listings are not certified as being active
and up to date or are associated with a
manufacturing establishment that is not
currently registered with FDA. FDA’s
regulations governing drug
establishment registration and drug
listing require registrants to notify FDA
if commercial distribution of a listed
drug is discontinued. They also require
firms to submit drug listing updates if
any material changes are made to
information previously submitted,
including a change in manufacturing
establishment(s). FDA has found that
listings for many drug products do not
comply with these regulations because
they have not been updated in over a
year, they have not been certified as
being up to date, or they identify within
the listing information at least one
manufacturing establishment that is not
currently registered with FDA. Many of
the drugs that are the subject of these
listings appear to no longer be in
commercial distribution. The purpose of
this notice is to remind registrants of
their legal obligations and announce
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SUMMARY:
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that, if drug listings are not
appropriately updated, certified, or
associated with a registered
establishment, they will be marked by
FDA as ‘‘inactive,’’ and the date of
inactivation will be added to the listing
record. This process will result in the
closure of drug records in all public
drug listing databases maintained by
FDA, including the National Drug Code
(NDC) Directory and the NDC SPL Data
Elements (NSDE) file, until corrections
to the relevant listings are made.
DATES: This notice is applicable
September 13, 2019.
FOR FURTHER INFORMATION CONTACT: Paul
Loebach, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2262, Silver Spring,
MD 20993–0002, 301–796–2173,
Paul.loebach@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 510 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360) and part 207 (21 CFR part 207) of
FDA’s regulations have long required
owners or operators of drug
manufacturing establishments to register
their establishments with FDA. In this
notice, the term ‘‘manufacture’’ refers to
all activities that trigger the drug
establishment registration obligation
under part 207, including repacking,
relabeling, and salvaging as defined in
part 207. Registrants are also required
by section 510 and part 207 to ‘‘list’’
each drug manufactured at their
establishments for commercial
distribution and submit updated drug
listing information to FDA twice yearly,
in June and December, notifying FDA if
this information has changed.
Specifically, section 510(i)(2) and (j) of
the FD&C Act require registered
establishments to report and
periodically update, among other
information, listing information for each
drug manufactured, prepared,
propagated, compounded, or processed
by them for commercial distribution in
the United States. Under 21 CFR 207.49,
207.53, and 207.54, registrants must
provide listing information that
corresponds to the activity or activities
they engage in for that drug.
As part of the drug listing information
they submit to FDA, registrants must
identify all establishments where a
‘‘listed drug’’ (as the term used in the
context of section 510 of the FD&C Act
and part 207) is manufactured or
provide a source NDC that enables FDA
to identify such establishments.
Registered establishments must also
report to FDA the discontinuation of
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commercial distribution of a listed drug
(section 510(j)(2)(B) of the FD&C Act)
and any material change in drug listing
information previously submitted,
which includes any changes in the
establishment(s) where the drug is
manufactured (section 510(j)(2)(D) of the
FD&C Act and 21 CFR 207.1). On
August 31, 2016, FDA amended part 207
to require drug manufacturers and other
registrants, at the time of registration
renewal, to certify that no changes have
occurred to their listings that were not
submitted or updated during the current
calendar year (81 FR 60170 and § 207.57
(21 CFR 207.57)). The first certifications
under this new requirement were due
during the registration renewal period
from October 1 to December 31, 2017
(81 FR 60170 at 60201 and § 207.57).
Establishments and labeler code holders
are also required to update contact
information (name, telephone number,
and email) submitted to FDA within 30
calendar days of any changes (21 CFR
207.25(g), 207.29(a)(3), and
207.33(c)(2)).
Complete, accurate, and up-to-date
establishment registration and drug
listing information is essential to FDA’s
mission. FDA relies on establishment
registration and drug listing information
in administering several key programs,
including drug establishment
inspections, postmarketing surveillance,
counterterrorism, recalls, drug quality
reports, adverse event reports,
monitoring of drug shortages and
availability, supply chain security, and
identification of products that are
marketed without an approved
application. If registration and listing
information is outdated or otherwise
unreliable (such as inaccurate,
superfluous, incomplete, or missing),
the integrity of the drug establishment
registration and listing database—and
FDA’s ability to rely on the reported
information for these programs—is
compromised. Drug registration and
listing information is also widely used
outside FDA for several purposes,
including electronic drug prescribing,
prescription drug reimbursement, and
patient education. A review of our data
shows that the types of errors discussed
in this notice affect tens of thousands of
records. Therefore, the inclusion of such
incorrect or outdated information in
FDA’s NDC Directory, the NSDE file, or
other public drug listing databases can
negatively affect public health.
II. Circumstances Under Which Certain
Drug Listing Information Becomes
Inaccurate
Each registrant must list all drugs it
manufactures for commercial
distribution within 3 days of initial
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]]>Agencies
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40414-40417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17398]
=======================================================================
-----------------------------------------------------------------------
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, 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) approve the proposed information collection
project: ``Safety Program in Perinatal Care (SPPC)--II Demonstration
Project.''
This proposed information collection was previously published in
the Federal Register on May 1, 2019, and allowed 60 days for public
comment. AHRQ received no substantive comments. The purpose of this
notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by date 30 days after
date of publication.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at [email protected] (attention: AHRQ's desk officer).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Safety Program in Perinatal Care (SPPC)--II Demonstration Project
Maternal mortality and severe maternal morbidity (SMM) increased
significantly and continuously in the United States (US) over the past
30 years. A considerable proportion of these adverse events are
attributable to preventable harm and unintended consequences arising
from clinical practice and the system of delivering perinatal care. To
address these alarming trends, AHRQ has developed the Safety Program in
Perinatal Care (SPPC). During its initial phase (SPPC-I), the program
was comprised of three pillars: Teamwork and communication, patient
safety bundles, and in situ simulations. Despite several promising
results, the evaluation of SPPC-I revealed considerable hospital
attrition due to heavy data burden and competing safety initiatives.
Also, differences in the local adaptation of the SPPC-I patient safety
bundles selected by implementation sites thwarted a meaningful cross-
site comparison of programmatic impact.
The current, second phase of the program (SPPC-II), focuses on
integrating the teamwork and communication pillar into patient safety
bundles developed by key professional organizations and implemented in
20+ US states with technical assistance by the Alliance for Innovation
on Maternal Health (AIM) program and funding from the Health Resources
and Services Administration (HRSA). Of note, the model used by AIM to
implement these bundles is through statewide perinatal quality
collaboratives (PQC) aiming to enroll all birthing hospitals in the
state in the PQC.
During the Planning Phase of SPPC-II, the contractor, Johns Hopkins
University (JHU), developed SPPC-II Training Toolkits for two AIM
patient safety bundles: Obstetric hemorrhage and severe hypertension in
pregnancy. The aim of the SPPC-II Demonstration Project is to implement
and evaluate an integrated AIM-SPPC II program that overlays the SPPC-
II Training Toolkits and the AIM patient safety bundles and program
infrastructure in two states--Oklahoma (OK), currently implementing the
severe hypertension bundle; and Texas (TX), currently implementing the
hemorrhage bundle.
Over the next five years, the AIM program is expected to cover
about two thirds of US states. Therefore, there is need to determine
the feasibility and impact of the proposed integrated AIM-SPPC II
program, and inform future government funding decisions regarding these
two programs.
To this end, the SPPC-II Demonstration Project has the following
goals:
(1) To implement the integrated AIM-SPPC II program in birthing
hospitals in OK and TX in coordination with AIM and the respective
state PQC;
(2) To assess the implementation of the integrated AIM-SPPC II
program in these hospitals; and
(3) To ascertain the short- and medium-term impact of the
integrated AIM-SPPC II program on hospital (i.e., perinatal unit)
teamwork and communication, patient safety, and key maternal health
outcomes.
This study is being conducted by AHRQ through its contractor, Johns
Hopkins University (JHU) and the AIM program, JHU's subcontractor,
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 and with respect to
quality measurement and improvement. 42 U.S.C. 299a (a)(1) and (2).
Method of Collection
To achieve the goals of this project the following data collections
will be implemented:
(a) Training of AIM Team Leads from 48 birthing hospitals in OK and
210 birthing hospitals in TX (i.e., all birthing hospitals enrolled in
the respective state
[[Page 40415]]
PQC) on using teamwork and communication tools and strategies in
clinical obstetric practice. The training will be conducted in-person,
through a full-day workshop organized in collaboration and coordination
with the AIM program and state PQCs, and led by JHU. Only one such
training workshop will be conducted in OK using the SPPC-II Toolkit for
severe hypertension in pregnancy. Given the size of the state,
potential long distances to be traveled by trainees, and the cost-
efficiency of coordinating with back-to-back regional PQC meetings
planned in TX this fall, five training workshops will be conducted in
this state using the SPPC-II Toolkit for obstetric hemorrhage. We
expect about half of the birthing hospitals in both states to send 2
hospital champions, of which one to be designated as AIM Team Lead, for
training. JHU will keep and bi-annually update a roster of AIM Team
Leads in each hospital to assess the need for training of new AIM Team
Leads if turnover occurs. Training workshop evaluation forms will be
distributed for completion by trainees on a voluntary basis to assess
the perceived utility of training workshops.
(b) Training of all frontline clinical staff in 48 birthing
hospitals in OK and 210 birthing hospitals in TX on teamwork and
communication tools and strategies will be coordinated by AIM Team
Leads in each hospital by: (a) Providing unique trainee IDs and
information for them to access 8 training e-modules online (with option
to leave voluntary comments/suggestions), and (b) using the JHU-
developed facilitator guide included in the SPPC-II Toolkits to
facilitate brief, in-person demonstration sessions on how to use the
information from the training e-modules in clinical practice. Each of
the eight training e-modules will take about 15 minutes to complete
online, for a total of about 120 minutes. Because these training e-
modules will be accessed and completed online, tracking of e-module
completion and re-take, needed to assess overall staff exposure to
training, is possible through the online training platform.
(c) Coaching calls will be organized monthly and led by JHU to
address program implementation questions and assist with potential
challenges. AIM Team Leads in all Demonstration Project hospitals will
be invited to join these calls and ask questions. A list of coaching
call participants and topics addressed will be maintained by JHU.
(d) AIM Team Lead self-administered baseline surveys will be made
available 2-3 weeks before the AIM Team Leads training workshop,
together with a corresponding consent form. The purpose of this survey
is to assess key characteristics of project hospitals, including human
resources, processes in place for AIM bundle implementation, and use of
teamwork and communication tools in clinical practice. Respondents will
have the option to complete the survey online or on paper, in line with
the current administration of the Hospital Survey on Patient Safety
Culture. The expected response rate for this survey is 95% in both
states.
(e) Clinical staff self-administered baseline surveys will be made
available before the first training workshop with AIM Team Leads,
together with a corresponding consent form. The purpose of this survey
is to assess baseline levels of previous teamwork and communication
training, overall use of teamwork and communication tools and
strategies, teamwork and communication perceptions, experience with AIM
bundle implementation. Three respondents will be randomly selected in
each hospital using comprehensive lists of clinical staff developed by
the AIM Team Leads. These lists will be updated by AIM Team Leads on a
quarterly basis to capture new hires and staff turnover. Respondents
will be given the option to complete the survey online or on paper, in
line with the administration of the national Hospital Survey on Patient
Safety Culture. The expected response rate for this survey is 85% in
both states.
(f) Qualitative, semi-structured interviews with AIM Team Leads
will be conducted by phone about 3-4 months after their training
workshop to assess the perceived utility of the training and assistance
needed with the rollout of training to all frontline clinical staff
using the e-modules and facilitation sessions to consolidate the
information. An interview guide developed based on the Consolidated
Framework for Implementation Research framework will be used to conduct
the interviews, together with a corresponding consent form.
(g) Clinical staff self-administered implementation surveys will be
made available at about 6, 18, and 30 months after the first AIM Team
Leads training, together with a corresponding consent forms, to assess
training knowledge, transfer, and results such as use of teamwork and
communication tools and strategies, teamwork and communication
perceptions, experience with AIM bundle implementation overlaid with
the teamwork and communication tools. The time points were chosen to
assess: Early adoption and results of the training (6-month survey);
adoption and results of the training at the time when unit culture
changes are expected per available implementation research (18-month
survey); and medium-term program sustainability (30-month survey). For
each survey, three respondents will be randomly selected in each
hospital using the most up to date comprehensive lists of clinical
staff developed by the AIM Team Leads. Respondents will have the option
to complete these surveys online or on paper, in line with the
administration of the national Hospital Survey on Patient Safety
Culture. The expected response rates are 80%, 77.5% and 75% for surveys
completed at 6, 18 and 30 months after AIM Team Leads training
workshops, respectively.
(h) AIM program data will be obtained from the AIM program, a
subcontractor of JHU's, under data use agreements with coordinating
bodies of state PQCs in the fall of 2019. These data are needed for the
evaluation of the SPPC-II Demonstration Project to assess changes in
key AIM program processes and maternal health outcomes, such as severe
maternal morbidity, throughout the project.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden ours for the
respondents' time to participate in the SPPC-II Demonstration Project.
An estimated 387 AIM Team Leads from the 258 Demonstration Project
sites will be trained during 8-hour workshops using the SPPC-II
Toolkit. An evaluation form, which will take approximately 5 minutes to
complete, will be distributed to them at the end of the workshop, and
about 75% of them (290 AIM Team Leads) are expected to complete the
evaluation. They will also be asked to extract from an available human
resources computerized database and update bi-annually rosters of
frontline clinical staff in their units--first extraction and each
update is expected to take about 5 minutes.
An estimated 15,480 frontline clinical staff are expected to be
trained using the training e-modules in the SPPC-II Toolkit. Completion
of the 8 e-modules will take about 2 hours. These trainings will be
complemented by four 15-min facilitation sessions led by AIM Team Leads
in their respective units. The AIM Team Leads will track attendance of
the facilitation session, work estimated to take about 15 minutes after
each session.
Monthly 1-hour coaching calls will be organized during the first 18
months of the project and at least one
[[Page 40416]]
representative from about half of the sites is expected to participate
at each coaching call.
Several surveys will be administered throughout the Demonstration
Project, specifically: Baseline, 20-minute surveys with AIM Team Leads
at each of 258 sites; baseline, 25-minute surveys with 3 randomly
selected frontline clinical staff at each of 258 sites; 30-minute
implementation surveys with 3 randomly selected frontline clinical
staff at each of 258 sites will be conducted at 6, 18, and 30 months
after the initial training workshops in both states. In addition, one-
hour qualitative interviews will be conducted with 25 AIM Team Leads in
the 2 states about 3-4 months after the initial training workshops in
their respective state.
We will inform AIM Team Leads of the DUAs put in place to access
AIM data--this will take about 5 minutes.
The total annual burden hours are estimated to be 54,654 hours.
Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Training of AIM Team Leads...................... 387 1 8 3,096
Frontline staff rosters developed by AIM Team 258 6 0.08 124
Leads..........................................
Evaluation form for training of AIM Team Leads.. 290 1 0.08 23
Training of frontline clinical staff............ 15,480 1 2.00 30,960
Facilitation sessions........................... 15,480 4 0.25 15,480
Tracking attendance of facilitation sessions.... 258 4 1.00 1,032
Coaching calls.................................. 129 18 1.00 2,322
Self-administered baseline surveys with AIM Team 258 1 0.33 85
Leads..........................................
Self-administered baseline surveys with clinical 774 1 0.42 325
staff..........................................
Qualitative semi-structured interviews with AIM 25 1 1.00 25
Team Leads.....................................
Self-administered implementation surveys with 774 1 0.50 387
clinical staff at 6 months.....................
Self-administered implementation surveys with 774 1 0.50 387
clinical staff at 18 months....................
Self-administered implementation surveys with 774 1 0.50 387
clinical staff at 30 months....................
DUA for AIM data................................ 258 1 0.08 21
---------------------------------------------------------------
Total....................................... 36,048 NA NA 54,654
----------------------------------------------------------------------------------------------------------------
Exhibit 2 shows the estimated annualized cost burden based on the
respondents' time to submit their data. The cost burden is estimated to
be $1,489,998.34 annually.
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Average
Form name Number of Total burden hourly wage Total cost
respondents hours rate * burden
----------------------------------------------------------------------------------------------------------------
Training of AIM Team Leads...................... 387 3,096 $49.83 $154,273.68
Frontline staff rosters developed by AIM Team 258 124 49.83 6,178.92
Leads..........................................
Evaluation form for training of AIM Team Leads.. 290 23 49.83 1,146.09
Training of frontline clinical staff............ 15,480 30,960 66.32 2,053,267.20
Facilitation sessions........................... 15,480 15,480 66.32 1,026,633.60
Tracking attendance of facilitation sessions.... 258 1,032 49.83 51,424.56
Coaching calls.................................. 129 2,322 66.32 153,995.04
Self-administered baseline surveys with AIM Team 258 85 49.83 4,235.55
Leads..........................................
Self-administered baseline surveys with clinical 774 325 66.32 21,554
staff..........................................
Qualitative semi-structured interviews with AIM 25 25 49.83 1,245.75
Team Leads.....................................
Self-administered implementation surveys with 774 387 66.32 25,665.84
clinical staff at 6 months.....................
Self-administered implementation surveys with 774 387 66.32 25,665.84
clinical staff at 18 months....................
Self-administered implementation surveys with 774 387 66.32 25,665.84
clinical staff at 30 months....................
DUA for AIM data................................ 258 21 49.83 1,046.43
---------------------------------------------------------------
Total....................................... 36,048 54,716 .............. 1,489,998.34
----------------------------------------------------------------------------------------------------------------
* National Compensation Survey: Occupational wages in the United States May 2017 ``U.S. Department of Labor,
Bureau of Labor Statistics.''
\a\ Hourly wage for nurse-midwives ($48.36; occupation code 29-1161).
\b\ Weighted mean hourly wage for obstetrician-gynecologists ($113.10; occupation code 29-1064; 30%); nurse-
midwives ($49.83; occupation code 29-1161; 30%); registered nurses ($35.36; occupation code 29-1161; 20%); and
nurse practitioners ($51.86; occupation code 29-1171; 20%).
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
[[Page 40417]]
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: August 8, 2019.
Virginia L. Mackay-Smith,
Associate Director.
[FR Doc. 2019-17398 Filed 8-13-19; 8:45 am]
BILLING CODE 4160-90-P
