82 FR 21233 - Agency Information Collection Activities: Proposed Collection; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 82, Issue 86 (May 5, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 86 (May 5, 2017)
| Page Range | 21233-21235 | |
| FR Document | 2017-09090 |
[Federal Register Volume 82, Number 86 (Friday, May 5, 2017)] [Notices] [Pages 21233-21235] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-09090] ----------------------------------------------------------------------- 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: ``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 [[Page 21234]] 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 ---------------------------------------------------------------------------------------------------------------- Number of Form name Number of responses per Hours per Total burden respondents respondent response hours ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Average Form name Number of Total burden hourly wage Total cost respondents hours rate * burden ---------------------------------------------------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- * 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 [[Page 21235]] 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
![Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 21233
when a PSO chooses to voluntarily product (PSWP) in its possession. The infections (CDI), organ dysfunction,
relinquish its status as a PSO for any PSO will meet the requirements of allergic reactions, and the development
reason, or when a PSO’s listing expires. Section 3.108(c)(2)(i) of the Patient of antibiotic resistance on both a patient
AHRQ has accepted a notification of Safety Rule regarding notification to level and population level. This project
voluntary relinquishment from the providers that have reported to the PSO. will assist acute care, long-term care and
Empire State Patient Safety Assurance In addition, according to Sections ambulatory care settings across the
Network PSO of its status as a PSO, and 3.108(c)(2)(ii) and 3.108(b)(3) of the United States in adopting and
has delisted the PSO accordingly. Patient Safety Rule regarding implementing antibiotic stewardship
DATES: The directories for both listed disposition of PSWP, the PSO has 90 programs, which are coordinated efforts
and delisted PSOs are ongoing and days from the effective date of delisting to improve the use of antibiotics by
reviewed weekly by AHRQ. The and revocation to complete the promoting the selection of the optimal
delisting was effective at 12:00 Midnight disposition of PSWP that is currently in antibiotic regimen, dose, route of
ET (2400) on March 30, 2017. the PSO’s possession. administration, and duration of therapy.
ADDRESSES: Both directories can be More information on PSOs can be More specifically, this project has the
accessed electronically at the following obtained through AHRQ’s PSO Web site following goals:
HHS Web site: http:// at http://www.pso.ahrq.gov. • Identify best practices in the delivery
www.pso.ahrq.gov/listed. Sharon B. Arnold, of antibiotic stewardship in the acute
FOR FURTHER INFORMATION CONTACT: Acting Director. care, long-term care and ambulatory
Eileen Hogan, Center for Quality care settings
[FR Doc. 2017–09091 Filed 5–4–17; 8:45 am]
Improvement and Patient Safety, AHRQ, • Adapt the Comprehensive Unit-Based
BILLING CODE 4160–90–P
5600 Fishers Lane, Room 06N94B, Safety Program (CUSP) model to
Rockville, MD 20857; Telephone (toll enhance antibiotic stewardship efforts
free): (866) 403–3697; Telephone (local): DEPARTMENT OF HEALTH AND in the health care settings
(301) 427–1111; TTY (toll free): (866) HUMAN SERVICES • Assess the adoption of CUSP for
438–7231; TTY (local): (301) 427–1130; antibiotic stewardship and evaluate
Email: pso@ahrq.hhs.gov. Agency for Healthcare Research and the effectiveness of the intervention in
SUPPLEMENTARY INFORMATION: Quality the participating health care systems
• Develop a bundle of technical and
Background Agency Information Collection adaptive interventions and associated
The Patient Safety Act authorizes the Activities: Proposed Collection; tools and educational materials
listing of PSOs, which are entities or Comment Request designed to support enhanced
component organizations whose antibiotic stewardship efforts
AGENCY: Agency for Healthcare Research • Provide technical assistance and
mission and primary activity are to and Quality, HHS.
conduct activities to improve patient training to health care organizations
ACTION: Notice. nationwide, using a phased approach,
safety and the quality of health care
delivery. to implement effective antibiotic
SUMMARY: This notice announces the
HHS issued the Patient Safety Rule to stewardship programs and
intention of the Agency for Healthcare
implement the Patient Safety Act. interventions
Research and Quality (AHRQ) to request
AHRQ administers the provisions of the • Improve communication and
that the Office of Management and
Patient Safety Act and Patient Safety teamwork between health care
Budget (OMB) approve the proposed
Rule relating to the listing and operation workers surrounding antibiotic
information collection project: ‘‘The
of PSOs. The Patient Safety Rule decision-making
AHRQ Safety Program for Improving
authorizes AHRQ to list as a PSO an • Improve communication between
Antibiotic Use.’’
entity that attests that it meets the health care workers and patients/
DATES: Comments on this notice must be families surrounding antibiotic
statutory and regulatory requirements
received by July 5, 2017. decision-making
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the ADDRESSES: Written comments should This study is being conducted by
requirements of the Patient Safety Act be submitted to: Doris Lefkowitz, AHRQ through its contractor Johns
and Patient Safety Rule, when a PSO Reports Clearance Officer, AHRQ, by Hopkins University, with subcontracted
chooses to voluntarily relinquish its email at doris.lefkowitz@AHRQ.hhs.gov. partner NORC. The AHRQ Safety
status as a PSO for any reason, or when Copies of the proposed collection Program for Improving Antibiotic Use is
a PSO’s listing expires. Section 3.108(d) plans, data collection instruments, and being undertaken pursuant to AHRQ’s
of the Patient Safety Rule requires specific details on the estimated burden mission to enhance the quality,
AHRQ to provide public notice when it can be obtained from the AHRQ Reports appropriateness, and effectiveness of
removes an organization from the list of Clearance Officer. health services, and access to such
federally approved PSOs. FOR FURTHER INFORMATION CONTACT: services, through the establishment of a
AHRQ has accepted a notification Doris Lefkowitz, AHRQ Reports broad base of scientific research and
from the Empire State Patient Safety Clearance Officer, (301) 427–1477, or by through the promotion of improvements
Assurance Network, PSO, a component email at doris.lefkowitz@AHRQ.hhs.gov. in clinical and health systems practices,
entity of the University of Buffalo, PSO SUPPLEMENTARY INFORMATION: including the prevention of diseases and
SRADOVICH on DSK3GMQ082PROD with NOTICES
number P0048, to voluntarily relinquish other health conditions. 42 U.S.C. 299.
its status as a PSO. Accordingly, the Proposed Project
In accordance with the Paperwork Method of Collection
Empire State Patient Safety Assurance
Network, PSO was delisted effective at Reduction Act, 44 U.S.C. 3501–3521, To achieve the goals of this project the
12:00 Midnight ET (2400) on March 30, AHRQ invites the public to comment on following data collections will be
2017. this proposed information collection. implemented:
Empire State Patient Safety Assurance Antibiotics can have serious adverse (1) Structural Assessments: A brief
Network, PSO has patient safety work effects including Clostridium difficile (five to seven questions), online
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![Federal Register / Vol. 82, No. 86 / Friday, May 5, 2017 / Notices 21235
AHRQ’s estimate of burden (including and closed for remainder of the DEPARTMENT OF HEALTH AND
hours and costs) of the proposed meeting) HUMAN SERVICES
collection(s) of information; (c) ways to 5. Healthcare Safety and Quality
enhance the quality, utility, and clarity Agency for Healthcare Research and
Improvement Research (HSQR)
of the information to be collected; and Quality
(d) ways to minimize the burden of the Date: June 22–23, 2017 (Open from
collection of information upon the 8:00 a.m. to 8:30 a.m. on June 22 Agency Information Collection
respondents, including the use of and closed for remainder of the Activities: Proposed Collection;
automated collection techniques or meeting) Comment Request
other forms of information technology. AGENCY: Agency for Healthcare Research
Comments submitted in response to ADDRESSES: (Below specifics where each
hotel will be held) and Quality, HHS.
this notice will be summarized and ACTION: Notice.
included in the Agency’s subsequent Gaithersburg Marriott, 9751
request for OMB approval of the Washingtonian Blvd., Gaithersburg, SUMMARY: This notice announces the
proposed information collection. All Maryland 20878. intention of the Agency for Healthcare
comments will become a matter of Research and Quality (AHRQ) to request
public record. FOR FURTHER INFORMATION CONTACT: (To that the Office of Management and
obtain a roster of members, agenda or Budget (OMB) approve the proposed
Sharon B. Arnold, minutes of the non-confidential portions information collection project ‘‘The Re-
Acting Director. of the meetings.) engineered Visit for Primary Care.’’
[FR Doc. 2017–09090 Filed 5–4–17; 8:45 am]
Mrs. Bonnie Campbell, Committee This proposed information collection
BILLING CODE 4160–90–P was previously published in the Federal
Management Officer, Office of
Extramural Research Education and Register on February 13, 2017 and
Priority Populations, Agency for allowed 60 days for public comment.
DEPARTMENT OF HEALTH AND AHRQ received one comment from the
HUMAN SERVICES Healthcare Research and Quality
public. The purpose of this notice is to
(AHRQ), 5600 Fishers Lane,
Agency for Healthcare Research and allow an additional 30 days for public
Rockville, Maryland 20857, comment.
Quality; Notice of Meetings Telephone (301) 427–1554.
DATES: Comments on this notice must be
AGENCY: Agency for Healthcare Research SUPPLEMENTARY INFORMATION: received by June 5, 2017.
and Quality (AHRQ), HHS. ADDRESSES: Written comments should
In accordance with section 10 (a)(2) of
ACTION: Notice of five AHRQ the Federal Advisory Committee Act (5 be submitted to: AHRQ’s OMB Desk
subcommittee meetings. U.S.C. App. 2), AHRQ announces Officer by fax at (202) 395–6974
meetings of the above-listed scientific (attention: AHRQ’s desk officer) or by
SUMMARY: The subcommittees listed
peer review groups, which are email at OIRA_submission@
below are part of AHRQ’s Health
subcommittees of AHRQ’s Health omb.eop.gov (attention: AHRQ’s desk
Services Research Initial Review Group
Services Research Initial Review Group officer).
Committee. Grant applications are to be
reviewed and discussed at these Committees. Each subcommittee FOR FURTHER INFORMATION CONTACT:
meetings. Each subcommittee meeting meeting will commence in open session Doris Lefkowitz, AHRQ Reports
will commence in open session before before closing to the public for the Clearance Officer, (301) 427–1477, or by
closing to the public for the duration of duration of the meeting. The email at doris.lefkowitz@AHRQ.hhs.gov.
the meeting. These meetings will be subcommittee meetings will be closed to SUPPLEMENTARY INFORMATION:
closed to the public in accordance with the public in accordance with the Proposed Project
5 U.S.C. App. 2 section 10(d), 5 U.S.C. provisions set forth in 5 U.S.C. App. 2
552b(c)(4), and 5 U.S.C. 552b(c)(6). section 10(d), 5 U.S.C. 552b(c)(4), and 5 The Re-Engineered Visit for Primary
DATES: See below for dates of meetings: U.S.C. 552b(c)(6) The grant applications Care
1. Health Care Research and Training and the discussions could disclose In accordance with the Paperwork
(HCRT) confidential trade secrets or commercial Reduction Act, 44 U.S.C. 3501–3521,
Date: May 25–26, 2017 (Open from property such as patentable material, AHRQ invites the public to comment on
8:00 a.m. to 8:30 a.m. on May 25 and personal information concerning this proposed information collection.
and closed for remainder of the individuals associated with the grant This project, The Re-engineered Visit for
meeting) applications, the disclosure of which Primary Care, directly addresses the
2. Healthcare Information Technology would constitute a clearly unwarranted agency’s goal to conduct research to
Research (HITR) invasion of personal privacy. enhance the quality of health care and
Date: June 7–9, 2017 (Open from 6:00 reduce avoidable readmissions, which
Agenda items for these meetings are
p.m. to 6:30 p.m. on June 7 and are a major indicator of poor quality and
subject to change as priorities dictate.
closed for remainder of the meeting) patient safety.
3. Health System and Value Research Sharon B. Arnold, Research from AHRQ’s Healthcare
(HSVR) Cost and Utilization Project (HCUP)
SRADOVICH on DSK3GMQ082PROD with NOTICES
Acting Director.
Date: June 14–15, 2017 (Open from [FR Doc. 2017–09130 Filed 5–4–17; 8:45 am]
indicates that in 2011 there were
8:30 a.m. to 9:00 a.m. on June 14 approximately 3.3 million adult hospital
BILLING CODE 4160–90–P
and closed for remainder of the readmissions in the United States.
meeting) Adults covered by Medicare have the
4. Healthcare Effectiveness and highest readmission rate (17.2 per 100
Outcomes Research (HEOR) admissions), followed by adults covered
Date: June 14–15, 2017 (Open from by Medicaid (14.6 per 100 admissions)
8:30 a.m. to 9:00 a.m. on June 14 and privately insured adults (8.7 per
VerDate Sep<11>2014 17:43 May 04, 2017 Jkt 241001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\05MYN1.SGM 05MYN1](https://thefederalregister.org/doc/82_FR_21319/page/3.svg)
Document Created: 2018-11-08 08:40:01
Document Modified: 2018-11-08 08:40:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this notice must be received by July 5, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 82 FR 21233 |
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