[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)]
[Notices]
[Pages 21233-21235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09090]


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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 the proposed information collection 
project: ``The AHRQ Safety Program for Improving Antibiotic Use.''

DATES: Comments on this notice must be received by July 5, 2017.

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 email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. Antibiotics can have serious adverse effects including 
Clostridium difficile infections (CDI), organ dysfunction, allergic 
reactions, and the development of antibiotic resistance on both a 
patient level and population level. This project will assist acute 
care, long-term care and ambulatory care settings across the United 
States in adopting and implementing antibiotic stewardship programs, 
which are coordinated efforts to improve the use of antibiotics by 
promoting the selection of the optimal antibiotic regimen, dose, route 
of administration, and duration of therapy.
    More specifically, 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 Comprehensive Unit-Based Safety Program (CUSP) model 
to enhance antibiotic stewardship efforts in the health care settings
 Assess the adoption of CUSP for antibiotic stewardship and 
evaluate the effectiveness of the intervention in the participating 
health care systems
 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/families surrounding antibiotic decision-making

    This study is being conducted by AHRQ through its contractor Johns 
Hopkins University, with subcontracted partner NORC. The AHRQ Safety 
Program for Improving Antibiotic Use 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 this project the following data collections 
will be implemented:
    (1) Structural Assessments: A brief (five to seven questions), 
online

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Structural Assessment Tool will be administered in all settings at 
baseline (pre-intervention) and at the end of the intervention period 
to obtain general information about facilities and existing stewardship 
infrastructure and changes in stewardship infrastructure and 
interventions as a result of the AHRQ Safety Program.
    (2) Team Antibiotic Review Form: The Stewardship Team will conduct 
monthly 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.) Were 
appropriate cultures ordered and best initial choice of antibiotics 
made? (3.) (after at least 24 hours) Are changes in antibiotic orders 
appropriate? (4.) What duration of therapy is appropriate?
    (3) The AHRQ Surveys on Patient Safety Culture 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.
    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: 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 
usage and clinical outcomes will be extracted from the EHRs of 
participating health care facilities and used to assess the impact of 
the AHRQ Safety Program for Improving Antibiotic Use.

Estimated Annual Respondent Burden

                                  Exhibit 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 Assessment........................             500               2             0.2             200
2. Team Antibiotic Review Form..................             333              90             0.2           5,994
3. Surveys on Patient Safety Culture (SOPS):
    a. HSOPS....................................           4,167               2              .5           4,167
    b. NHSOPS...................................           4,167               2              .5           4,167
    c. MOSOPS...................................           4,167               2              .5           4,167
4. Semi-structured qualitative interviews.......              30               2               1              60
    (Physicians--line 1; Other Health                         60               2               1             120
     Practitioners--line 2).....................
5. EHR data.....................................             500              12              .5           3,000
                                                 ---------------------------------------------------------------
    Total.......................................          13,924             N/A             N/A          21,875
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                                                      Average
                    Form name                        Number of     Total burden     hourly wage     Total cost
                                                    respondents        hours          rate *          burden
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1. Structural Assessment........................             500             200      \a\ $98.83         $19,766
2. Team Antibiotic Review Form..................             333           5,994       \a\ 98.83         592,387
3. SOPS:
    a. HSOPS....................................           4,167           4,167       \b\ 27.87         116,134
    b. NHSOPS...................................           4,167           4,167       \b\ 27.87         116,134
    c. MOSOPS...................................           4,167           4,167       \b\ 27.87         116,134
4. Semi-structured qualitative interviews.......              30              60       \a\ 98.83           5,930
    (Physicians--line 1; Other Health                         60             120       \b\ 27.87           3,344
     Practitioners--line 2).....................
5. EHR data.....................................             500           3,000       \b\ 27.87          83,610
                                                 ---------------------------------------------------------------
    Total.......................................          13,924          21,875             N/A       1,053,439
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* 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 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 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.

Sharon B. Arnold,
Acting Director.
[FR Doc. 2017-09090 Filed 5-4-17; 8:45 am]
BILLING CODE 4160-90-P