83 FR 5262 - Agency Information Collection Activities: Proposed Collection; Comment Request

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

Federal Register Volume 83, Issue 25 (February 6, 2018)

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 ``Expanding the Comprehensive Unit-based Safety Program (CUSP) to Reduce Central Line-Associated Blood Stream Infections (CLABSI) and Catheter-Associated Urinary Tract Infections (CAUTI) in Intensive Care Units (ICU) with Persistently Elevated Infection Rates.'' This proposed information collection was previously published in the Federal Register on July 28, 2017, and allowed 60 days for public comment. AHRQ did not receive any substantive public comments. In response to internal project team feedback, the proposed data collection has been modified in order to increase efficiency and decrease respondent burden. Modifications include consolidation of two data collection tools (the Team Checkup Tool and the ICU Assessment) into one ICU Assessment and decreasing the frequency of administration. The modifications also now require broad administration of the ICU Action Plan, which previously was administered only to those sites that had a site visit. The purpose of this notice is to allow an additional 30 days for public comment.

[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Notices]
[Pages 5262-5264]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-02289]


=======================================================================
-----------------------------------------------------------------------

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 ``Expanding the Comprehensive Unit-based Safety Program (CUSP) 
to Reduce Central Line-Associated Blood Stream Infections (CLABSI) and 
Catheter-Associated Urinary Tract Infections (CAUTI) in Intensive Care 
Units (ICU) with Persistently Elevated Infection Rates.''
    This proposed information collection was previously published in 
the Federal Register on July 28, 2017, and allowed 60 days for public 
comment. AHRQ did not receive any substantive public comments. In 
response to internal project team feedback, the proposed data 
collection has been modified in order to increase efficiency and 
decrease respondent burden. Modifications include consolidation of two 
data collection tools (the Team Checkup Tool and the ICU Assessment) 
into one ICU Assessment and decreasing the frequency of administration. 
The modifications also now require broad administration of the ICU 
Action Plan, which previously was administered only to those sites that 
had a site visit. The purpose of this notice is to allow an additional 
30 days for public comment.

DATES: Comments on this notice must be received by March 8, 2018.

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

    Expanding the Comprehensive Unit-based Safety Program (CUSP) to 
reduce Central Line-Associated Blood Stream Infections (CLABSI) and 
Catheter-Associated Urinary Tract Infections (CAUTI) in Intensive Care 
Units (ICU) with persistently elevated infection rates.
    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection.
    Healthcare-associated infections, or HAIs, are a highly significant 
cause of illness and death for patients in the U.S. health care system. 
At any given time, HAIs affect one out of every 25 hospital inpatients. 
More than a million of these infections occur across the health care 
system every year, leading to significant patient harm and the annual 
loss of tens of thousands of lives, and costing billions of dollars 
each year. Some of the most prevalent HAIs include: Surgical site 
infections (SSIs), catheter-associated urinary tract infections, 
central-line associated blood stream infections, and ventilator-
associated pneumonia (VAP). It is estimated that CAUTIs affect 
approximately 250,000 hospital patients per year, and approximately 
40,000 CLABSI cases occur annually with a mortality rate from 12 to 25 
percent.
    From 2008-2012, AHRQ supported the National Implementation of the 
Comprehensive Unit-Based Safety Program (CUSP) to reduce Central Line-
Associated Blood Stream Infections (CLABSI) under an ACTION contract 
with the Health Research and Educational Trust (HRET), in partnership 
with Johns Hopkins University and the Michigan Hospital Association. 
From 2011-2015, AHRQ expanded its CUSP efforts to include the national 
implementation of CUSP for CAUTI in hospitals across the United States. 
This effort was carried out under an ACTION II contract with HRET, in 
partnership with Johns Hopkins University and the Michigan Hospital 
Association.
    As part of the Department of Health and Human Services National 
Action Plan to Prevent Healthcare-Associated Infections, AHRQ has 
supported the implementation and adoption of the CUSP for CLABSI and 
CUSP for CAUTI, and is applying the principles and concepts that have 
been learned from these HAI reduction efforts to ICUs with persistently 
elevated infection rates.

[[Page 5263]]

Results of Implementation of CUSP for CLABSI and CAUTI

    The nationwide CUSP for CLABSI project was implemented with teams 
at more than 1,100 adult ICUs in 44 states over a 4-year period. ICUs 
participating in this project reduced the rate of CLABSIs nationally 
from 1.915 infections per 1,000 central line days to 1.133 infections 
per 1,000 line days, an overall reduction of 41 percent. However, not 
all ICUs performed equally well.
    The CUSP for CAUTI project implemented CUSP in nine cohorts, 
representing over 1,600 hospital units in over 1,200 hospitals located 
across 40 states, the District of Columbia, and Puerto Rico. Inpatient 
CAUTI rates in non-ICUs were decreased by 30%. However, CAUTI rates in 
ICUs were not reduced significantly.
    In other words, while the overall results of the implementation of 
CUSP for CLABSI and CUSP for CAUTI have shown remarkable progress, not 
all ICUs in the projects have achieved the intended rate reductions, 
nor have all ICUs participated in the two projects. Moreover, a 
significant number of institutions and ICUs continue to have 
persistently elevated infection rates. There are institutions that have 
varying rates of infections within the same institution, indicating 
that infection control is often a unit-based issue.
    In sum, despite the significant overall reductions in CLABSI and 
CAUTI rates that have been achieved in these two projects, there is 
evidence that ICUs have generally faced challenges in reducing CAUTI 
rates, and that many hospitals still are not where they should be in 
reducing CLABSI rates. Modified approaches and strategies for the CUSP 
intervention need to be developed and implemented to reach ICUs with 
persistently elevated CLABSI and CAUTI rates and help them succeed in 
preventing these infections. To address this need, AHRQ will launch 
this project aimed at spreading nationally implementation of an 
adaptation of CUSP for CLABSI and CAUTI for ICUs with persistently 
elevated rates, optimizing the approach to maximize effectiveness and 
further preventing these infections throughout the United States.
    This project has the following goals:
     Reduce CLABSI and CAUTI in ICUs with persistently elevated 
rates.
     Revise and augment current CUSP training resources and 
materials for CUSP for CLABSI and CAUTI in ICUs with persistently 
elevated rates. The resulting toolkit will be intended for use in ICUs 
whose infection rates for either or both of these HAIs are persistently 
elevated compared to other ICUs.
     Recruit 450-600 ICUs nationally with persistently elevated 
rates to demonstrate the utility of applying a modified CUSP for CLABSI 
and CUSP for CAUTI during the performance period to reduce rates of 
CLABSI and CAUTI in these ICUs.
     Assess the adoption of the modified CUSP for CLABSI and 
CAUTI and evaluate the effectiveness of the intervention in the 
participating ICUs.
    This study is being conducted by AHRQ through its contractor HRET. 
Expanding the Comprehensive Unit-based Safety Program (CUSP) to reduce 
Central Line-Associated Blood Stream Infections (CLABSI) and Catheter-
Associated Urinary Tract Infections (CAUTI) in Intensive Care Units 
(ICU) with persistently elevated infection rates is being undertaken 
pursuant to AHRQ's statutory authority to conduct and support research 
on health care and on systems for the delivery of such care, including 
activities with respect to the quality, effectiveness, efficiency, 
appropriateness and value of health care 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:
    (1) ICU Assessment Tool: The ICU assessment tool will be completed 
by the unit project team leader in collaboration with individuals with 
strong knowledge of current clinical and safety practices in the ICU, 
such as the ICU manager, infection preventionist, quality leader, 
clinical educator, or clinical nurse specialist at the start of the 
cohort. The purpose of this assessment is to understand current HAI 
prevention practices, policies, and procedures to tailor the 
educational program to meet the needs of the ICU. The assessment also 
addresses unit safety culture and CUSP safety practices with questions 
from the AHRQ Team Checkup Tool. Results from this assessment will be 
one of the key tools participating ICUs will use in developing their 
action plans.
    (2) Action plans: After completing and receiving the results of 
their ICU assessment, the unit team members (such as the ICU manager, 
quality leader, clinical educator, or clinical nurse specialist) will 
complete an action plan. The unit team will be encouraged to use other 
data sources (e.g., CAUTI and/or CLABSI rates from the National 
Healthcare Safety Network [NHSN], culture assessments) to identify gaps 
that they plan to address through participation in the project. ICU 
teams, with coaching support from their state lead, clinical mentor, 
and subject matter experts, will determine which educational materials 
will help the ICU achieve its action plan goals. ICU teams, state 
leads, and clinical mentors will refer to these action plans to monitor 
progress in achieving the goals.
    (3) Site Visits: State leads and clinical mentors will coordinate 
state-level, in-person site visits for 200 participating hospital units 
over the entire project. Site visits are an opportunity for state leads 
and clinical mentors to meet with ICU teams and their leadership to 
strengthen relationships, engage in open discussion about infection 
prevention, and discuss the unit's progress in implementing its action 
plan. The Site Visit Guidance document helps state leads identify ICUs 
to visit, plan agendas, schedule visits, prepare for visits, and plan 
discussion questions.
    This data collection effort will be part of a comprehensive 
evaluation strategy to assess the adoption of the Expansion of the 
Comprehensive Unit-Based Safety Program (CUSP) for CLABSI and CAUTI in 
ICUs with persistently elevated rates; measure the effectiveness of the 
interventions in the participating units; and evaluate the 
characteristics of teams that are associated with successful 
implementation and improvements in outcomes.
    The evaluation of this data collection is largely foundational in 
nature as AHRQ seeks information on the implementation and 
effectiveness of the CUSP for CLABSI and CAUTI in ICUs with 
persistently elevated rates. The evaluation of the tools above will 
utilize a pre-post design, comparing practices, policies and procedures 
before and after participating in the program.

Estimated Annual Respondent Burden

[[Page 5264]]



                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
----------------------------------------------------------------------------------------------------------------
ICU Assessment..................................             150               1            1.25           187.5
ICU Action Plan.................................             150               1               2             300
Site Visits.....................................             100               1               4             400
                                                 ---------------------------------------------------------------
    Total.......................................             400             N/A             N/A           887.5
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours          rate *          burden
----------------------------------------------------------------------------------------------------------------
ICU Assessment Tool.............................             150           187.5      \a\ $52.58       $9,858.75
ICU Action Plan.................................             150             300       \a\ 52.58          15,774
Site Visits.....................................             100             100       \b\ 27.87           2,787
                                                  ..............             200       \c\ 34.70           6,940
                                                  ..............              50       \a\ 52.58           2,629
                                                  ..............              50       \d\ 98.83        4,941.50
                                                 ---------------------------------------------------------------
    Total.......................................             400           887.5             N/A       42,930.25
----------------------------------------------------------------------------------------------------------------
\a\ Based on the mean wages for 11-9111 Medical and Health Services Managers.
\b\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare
  Practitioners and Technical Workers, All Other.
\c\ Based on the mean wages for 29-1141 Registered Nurse.
\d\ Based on the mean wages for 29-1069 Physicians and Surgeons, All other.
National Compensation Survey: Occupational wages in the United States May 2016 ``U.S. Department of Labor,
  Bureau of Labor Statistics:'' http://www.bls.gov/oes/current/oes_stru.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.

Karen J. Migdail,
Chief of Staff.
[FR Doc. 2018-02289 Filed 2-5-18; 8:45 am]
BILLING CODE 4160-90-P