[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Notices]
[Pages 12251-12254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06193]


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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, HHS.

ACTION: Notice.

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SUMMARY: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request that the Office of 
Management and Budget (OMB) approve a revision and to extend the time 
period of the proposed information collection project ``The AHRQ Safety 
Program for Improving Antibiotic Use.''

DATES: Comments on this notice must be received by May 31, 2019.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    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.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by emails at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

The AHRQ Safety Program for Improving Antibiotic Use

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. The Agency for Healthcare Research and Quality (AHRQ) 
requests to revise and extend the currently approved AHRQ Safety 
Program for Improving Antibiotic Use. The AHRQ Safety Program for 
Improving Antibiotic Use (the ``AHRQ Safety Program'') aims to help 
facilities implement antibiotic stewardship programs and to reduce 
unnecessary antibiotic prescribing. The AHRQ Safety Program has already 
been implemented in a pilot of integrated delivery systems and a 
national cohort of 400 acute care hospitals, and is currently being 
implemented in a national cohort of 500 long-term care facilities. The 
AHRQ Safety Program was last approved by OMB on September 25, 2017 and 
will expire on September 30, 2020. The request for extension is to 
allow for completion of activities and data collection in the AHRQ 
Safety Program, which are scheduled to occur through March 30, 2021. 
The OMB control number for the AHRQ Safety Program is 0935-0238. All of 
the supporting documents for the current AHRQ Safety Program can be 
downloaded from OMB's website at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201707-0935-003.
    The 2017 OMB clearance included one response for the Structural 
Assessment and the Medical Office Survey on Patient Safety Culture 
(MOSOPS), but did not include electronic health record (EHR) data or a 
second response for the Structural Assessment or MOSOPS for the 4th 
cohort planned for ambulatory settings. This was because the original 
OMB clearance expiration date fell in the middle of the planned 4th 
cohort, so the second Structural Assessment and MOSOPS were not within 
the approved information collection period, and EHR data collection 
would have been incomplete. In addition, the project team was not 
certain that the ambulatory care practices would be able to access EHR 
data. Based on the experience of the pilot cohort, however, it is 
believed that many ambulatory practices can access this data, and that

[[Page 12252]]

these practices are more likely to feasibly participate in the AHRQ 
Safety Program. The revision also updates the estimated annual burden 
accordingly, and includes changes to the data collection forms which 
will be used for the ambulatory care cohort based on lessons learned 
during the pilot cohort.

Background for This Collection

    As part of the Department of Health and Human Services (DHHS) 
Hospital Acquired Infection (HAI) National Action Plan (NAP), AHRQ has 
supported the implementation and adoption of the Comprehensive Unit-
based Safety Program (CUSP) to reduce Central-Line Associated 
Bloodstream Infections (CLABSI) and Catheter-Associated Urinary Tract 
Infections (CAUTI), and subsequently applied CUSP to other clinical 
challenges, including reducing surgical site infections and improving 
care for mechanically ventilated patients. As part of the National 
Action Plan for Combating Antibiotic-Resistant Bacteria (CARB NAP) to 
increase antibiotic stewardship (defined as organized efforts to 
promote the judicious use of antibiotics) across all health care 
settings, AHRQ is applying the principles and concepts that have been 
learned from these HAI reduction efforts to antibiotic stewardship 
(AS).
    Antibiotic therapy has saved countless lives over the past several 
decades. However, bacterial resistance to antibiotics has followed 
closely on the heels of each new agent's introduction. This has led to 
an epidemic of antibiotic resistance, with drug choices for some 
bacterial infections becoming increasingly limited, expensive, and in 
some cases nonexistent. While antibiotics remain a vital and necessary 
cornerstone to the treatment of infections, it is estimated that 20-50% 
of all antibiotics prescribed in U.S. acute care hospitals are either 
unnecessary or inappropriate. When antibiotics are used 
inappropriately, bacterial development of resistance is supported in 
the absence of any therapeutic benefit, and patients receiving 
unnecessary or inappropriate antibiotics are also exposed to the risk 
of adverse effects such as rash or renal injury as well as the risk of 
Clostridioides difficile infection which can cause a deadly diarrhea. 
Unlike misuse of other medications, the misuse of antibiotics can 
adversely impact the health of patients who are not even exposed to 
them because of the potential for spread of resistant organisms. The 
Centers for Disease Control and Prevention (CDC) estimates that each 
year at least two million illnesses and 23,000 deaths are caused by 
drug-resistant bacteria in the United States alone.
    While approaches including development of new antibiotic agents, 
increased surveillance for antibiotic resistance, prevention of HAIs, 
and prevention of transmission of resistant infections are important 
efforts to combat antibiotic resistance, it is critical to curb the 
inappropriate use of antibiotics to slow the emergence of antibiotic 
resistance and to preserve efficacy of existing antibiotics and those 
under development.
    As of January 1st, 2017, The Joint Commission (TJC)'s new 
Antimicrobial Stewardship Standard requires that all acute care 
hospitals have robust antibiotic stewardship programs. In addition, 
starting on November 28, 2017, the Centers for Medicare & Medicaid 
Services (CMS) required that all long-term care facilities that receive 
reimbursement from CMS have antibiotic stewardship programs in place.
    The Comprehensive Unit-Based Safety Program (CUSP), developed at 
the Armstrong Institute at Johns Hopkins University, combines 
improvement in patient safety culture, teamwork, and communication 
together with a technical bundle of interventions to improve patient 
safety. CUSP is a powerful culture change tool, which has been 
successfully utilized to reduce CLABSI in ICUs in Michigan and Rhode 
Island and subsequently to reduce CLABSI by 41% in more than 1,000 ICUs 
in 44 states, Puerto Rico and the District of Columbia. Although 
evidence-based recommendations for prevention of CLABSI had existed for 
years, the combination of safety culture change on units and 
implementation of technical interventions resulted in significant 
reductions in CLABSI and introduced the concept that a rate of zero 
CLABSIs is achievable. CUSP is also being used to reduce other HAIs in 
multiple settings (http://www.ahrq.gov/professionals/quality-patient-safety/hais/index.html).
    This project will assist hospitals, nursing homes, and ambulatory 
care sites across the United States in adopting and implementing AS 
programs and interventions.
    This project has the following goals:

     Identify best practices in the delivery of antibiotic 
stewardship in the acute care, long-term care and ambulatory care 
settings
     Adapt the CUSP model to enhance antibiotic stewardship 
efforts in the health care settings
     Develop a bundle of technical and adaptive interventions 
and associated tools and educational materials designed to support 
enhanced antibiotic stewardship efforts
     Provide technical assistance and training to health care 
organizations nationwide (using a phased approach) to implement 
effective antibiotic stewardship programs and interventions
     Improve communication and teamwork between health care 
workers surrounding antibiotic decision-making
     Improve communication between health care workers and 
patients and families surrounding antibiotic decision-making
     Conduct a comprehensive evaluation to assess the adoption 
of the CUSP for AS in acute care, long-term care and ambulatory care 
settings to identify the effectiveness of the program, process 
outcomes, and lessons learned

    The project will be implemented in four cohorts; (1) Cohort 1 is a 
pilot limited to 10 facilities each in three integrated delivery 
systems spanning acute care, long-term care, and ambulatory settings; 
(2) Cohort 2 will expand to include 250-500 acute care hospitals; (3) 
Cohort 3 will include 250-500 long-term care facilities; and (4) Cohort 
4 will include 250-500 ambulatory care facilities.
    The AHRQ Safety Program is being undertaken pursuant to AHRQ's 
mission to enhance the quality, appropriateness, and effectiveness of 
health services, and access to such services, through the establishment 
of a broad base of scientific research and through the promotion of 
improvements in clinical and health systems practices, including the 
prevention of diseases and other health conditions. 42 U.S.C. 299.

Method of Collection

    To achieve the goals of the AHRQ Safety Program, the following data 
collections will be implemented:
    (1) Structural Assessments: A brief, eight question, online 
Structural Assessment Tool will be administered at baseline (pre-
intervention) and at the end of the intervention period to obtain 
general information about facilities and stewardship infrastructure and 
changes to stewardship infrastructure and interventions that are 
anticipated to be sustained as a result of the AHRQ Safety Program (one 
response per facility for the 4th cohort in ambulatory settings was 
included in the original OMB review, this revision adds an additional 
response per facility, relevant changes made to line 1.b. in Exhibits 
A.1. and A.2.).
    (2) Team Antibiotic Review Form: The Stewardship Team in hospitals 
and nursing homes will conduct monthly

[[Page 12253]]

reviews of at least 10 patients who received antibiotics and fill out 
an assessment tool in conjunction with frontline staff to determine if 
the ``four moments of antibiotic decision-making'' are being considered 
by providers. The four moments can be summarized as: (1) Is an 
infection present requiring antibiotics? (2) Are appropriate cultures 
being ordered and is the most optimal initial choice of antibiotics 
being prescribed? (3) (after at least 24 hours) Is it appropriate to 
make changes to the antibiotic regimen (e.g., stop therapy, narrow 
therapy, change from intravenous to oral therapy)? (4) What duration of 
therapy is appropriate?
    (3) The AHRQ Surveys on Patient Safety Culture: The appropriate 
versions of these surveys and the MOSOPS will be administered to all 
participating staff at the beginning and end of the intervention. Each 
survey asks questions about patient safety issues, medical errors, and 
event reporting in the respective settings. The surveys will be 
administered to all participating staff at the beginning and end of the 
intervention. (One response per respondent for the 4th cohort in 
ambulatory settings was included in the original OMB review, this 
revision adds an additional response per respondent, relevant changes 
made to line 3.d. in Exhibits A.1. and A.2.).
    a. The Hospital Survey on Patient Safety Culture (HSOPS) will be 
utilized to evaluate safety culture for acute care hospitals.
    b. The Nursing Home Survey on Patient Safety Culture (NHSOPS) will 
be administered in long-term care.
    c. The Medical Office Survey on Patient Safety Culture (MOSOPS) 
will be administered in ambulatory care centers.
    (4) Semi-structured qualitative interviews: During the project 
pilot period with Cohort 1, in-person and/or telephone discussions will 
be held before and after implementation with stewardship champions/
organizational leaders, physicians, pharmacists, nurse practitioners, 
physician assistants, nurses, certified nursing assistants and others 
deemed relevant, to learn about the facilitators and barriers to a 
successful antibiotic stewardship program. Specific areas of interest 
include stakeholder perceptions of implementation process and outcomes, 
including successes and challenges with carrying out project tasks and 
perceived utility of the project; staff roles, engagement and support; 
and antibiotic prescribing etiquette & culture (i.e., social norms and 
local cultural factors that contribute to prescribing behavior at the 
facility/unit-level).
    (5) Electronic Health Record (EHR) data: Unit-level antibiotic 
therapy prescriptions and antibiotic use for diagnosed respiratory 
conditions will be extracted from the Electronic Health Records (EHRs) 
of participating units and used to assess the impact of the AHRQ Safety 
Program. (4th cohort in ambulatory settings portion is new from 
original OMB review, noted in line 6 in Exhibits A.1. and A.2.).

Estimated Annual Respondent Burden

    Exhibit A.1 shows the estimated annualized burden hours for the 
respondents' time to complete the Structural Assessments, Team 
Antibiotic Review Forms, AHRQ Patient Safety Culture Surveys, semi-
structured qualitative interviews, and EHR data extractions. Data will 
be collected from 30 acute care, long-term care, and ambulatory care 
sites during the Cohort 1 one-year pilot period; up to 500 acute care 
hospitals in Cohort 2; up to 500 long-term care facilities in Cohort 3; 
and up to 500 ambulatory care sites in Cohort 4. With this revision, 
the total estimated annualized burden hours for the data collection 
activities are 27,064.

                                 Exhibit A.1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
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1. Structural Assessments:
    a. Structural Assessments--Cohorts 1, 2 and              343               2             0.2             137
     3 (baseline, post-intervention)............
    b. Structural Assessments--Cohort 4                      167               2             0.2              67
     (baseline and endline).....................
2. Team Antibiotic Review Form (Cohorts 1, 2,                337              90            0.25           7,583
 and 3).........................................
3. AHRQ Patient Safety Culture Surveys:
    a. HSOPS, NHSOPS, MOSOPS (Cohort 1).........              83               2             0.5              83
    b. HSOPS (Cohort 2).........................           4,167               2             0.5           4,167
    c. NHSOPS (Cohort 3)........................           4,167               2             0.5           4,167
    d. MOSOPS (Cohort 4)........................           4,167               2             0.5           4,167
4. Semi-structured qualitative interviews
 (Cohort 1):
    a. Physicians...............................              30               2               1              60
    b. Other Health Practitioners...............              60               2               1             120
5. EHR data (Cohorts 1, 2, and 3)...............             334              12               1           4,008
    6. EHR data (Cohort 4)......................             167              15               1           2,505
                                                 ---------------------------------------------------------------
        Total...................................          14,022  ..............  ..............          27,030
----------------------------------------------------------------------------------------------------------------

    Exhibit A.2 shows the estimated annualized cost burden based on the 
respondents' time to complete the data collection forms. The total cost 
burden is estimated to be $1,311,096.

                                  Exhibit A.2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours        wage rate *       burden
----------------------------------------------------------------------------------------------------------------
1. Structural Assessments:
    a. Structural Assessments--Cohorts 1, 2 and              343             137      \a\ $98.83         $13,540
     3 (baseline, post-intervention)............

[[Page 12254]]

 
    b. Structural Assessments--Cohort 4                      167              67       \a\ 98.83           6,622
     (baseline and endline).....................
2. Team Antibiotic Review Form (Cohorts 1, 2,                337           7,583       \a\ 98.83         749,428
 and 3).........................................
3. AHRQ Patient Safety Culture Surveys:
    a. HSOPS, NHSOPS, MOSOPS (Cohort 1).........              83              83       \b\ 27.87           2,313
    b. HSOPS (Cohort 2).........................           4,167           4,167       \b\ 27.87         116,134
    c. NHSOPS (Cohort 3)........................           4,167           4,167       \b\ 27.87         116,134
    d. MOSOPS (Cohort 4)........................           4,167           4,167       \b\ 27.87         116,134
4. Semi-structured qualitative interviews
 (Cohort 1):
    a. Physicians...............................              30              60       \a\ 98.83           5,930
    b. Other Health Practitioners...............              60             120       \b\ 27.87           3,344
5. EHR data (Cohorts 1, 2, and 3)...............             334           4,008       \b\ 27.87         111,703
6. EHR data (Cohort 4)..........................             167           2,505       \b\ 27.87          69,814
                                                 ---------------------------------------------------------------
        Total...................................          14,022          27,064  ..............       1,311,096
----------------------------------------------------------------------------------------------------------------
* 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.
 \a\ Based on the mean wages for 29-1069 Physicians and Surgeons, All Other.
 \b\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare
  Practitioners and Technical Workers, All Other.

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.

Gopal Khanna,
Director.
[FR Doc. 2019-06193 Filed 3-29-19; 8:45 am]
BILLING CODE 4160-90-P