82 FR 22831 - 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 95 (May 18, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 95 (May 18, 2017)
| Page Range | 22831-22833 | |
| FR Document | 2017-10065 |
[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)] [Notices] [Pages 22831-22833] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-10065] ----------------------------------------------------------------------- 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 Enhancing Surgical Care and Recovery.'' DATES: Comments on this notice must be received by July 17, 2017. ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 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 doris.lefkowitz@AHRQ.hhs.gov. 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. The AHRQ Safety Program for Enhancing Surgical Care and Recovery is a quality improvement project that aims to provide technical assistance to hospitals to help them implement evidence-based practices to improve outcomes and prevent complications among patients who undergo surgery. Enhanced recovery pathways are a constellation of preoperative, intraoperative, and postoperative practices that decrease complications and accelerate recovery. A number of studies and meta- analyses have demonstrated successful results. In order to facilitate broader adoption of these evidence-based practices among U.S. hospitals, this AHRQ project will adapt the Comprehensive Unit-based Safety Program (CUSP), which has been demonstrated to be an effective approach to reducing other patient harms, to enhanced recovery after surgery. The approach uses a combination of clinical and cultural (i.e., technical and adaptive) intervention components, which include promoting leadership and frontline staff engagement, close teamwork among surgeons, anesthesia providers, and nurses, as well as enhancing patient communication and engagement. Interested hospitals will voluntarily participate. This project has the following goals:Improve outcomes of surgical patients by disseminating and supporting implementation of evidence-based enhanced recovery practices within the CUSP framework Develop a bundle of technical and adaptive interventions and associated tools and educational materials to support implementation Provide technical assistance and training to hospitals for implementing enhanced recovery practices Assess the adoption, and evaluate the effectiveness of, the intervention among the participating hospitals [[Page 22832]] This project is being conducted by AHRQ through its contractor Johns Hopkins University; with subcontractors Westat, and the American College of Surgeons. The AHRQ Safety Program for Enhancing Surgical Care and Recovery 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) Safety Culture Survey. Hospitals will assess the impact of participation in the project on perioperative safety culture by having their staff members who will be part of the enhanced recovery program complete a survey from the AHRQ Surveys on Patient Safety Culture (SOPS) at the beginning and end of the program. The hospital's enhanced recovery project team will receive their survey results and then debrief their staff on their safety culture and identify opportunities for further improvement. The national project team will provide technical assistance for this effort. Participating hospitals will promote awareness of the survey among their staff, coordinate implementation of the survey, encourage and provide staff the time to complete the survey, and organize a local debrief of the reports of their hospital's results. The national project team will assist this effort by providing an electronic portal for hospital staff to anonymously complete the survey and by analyzing the data and sending a report to the hospital. Data will also be analyzed in aggregate across all participating hospitals to evaluate the impact of the overall quality improvement effort on measured safety culture. (2) Patient Experience Survey--Hospitals will also assess the impact of participation in the project on patients' experience with care. This will be done via administration of a patient experience survey to patients discharged after a qualifying surgery. Patients will receive a pre-implementation assessment of patient experience after a qualifying surgery and a post-implementation assessment of patient experience will be administered to patients were treated in the enhanced recovery program at participating hospitals. The survey will be administered by the national project team. Hospitals will provide patient contact information to the project team after execution of a data use agreement. This information will be provided to the national project team to send the survey to patients on behalf of the hospital. The national project team will provide a summative report to each hospital with the hospital's results to promote additional local quality improvement work. Data will also be analyzed in aggregate across all participating hospitals to evaluate the impact of the overall quality improvement effort on patient experience of care. (3) Readiness and Implementation Assessments: Semi-structured qualitative interviews. Semi-structured qualitative interviews will be conducted with key stakeholders at participating hospitals (e.g., project leads, physician project champions, etc.). These include a readiness assessment conducted after a hospital's enrollment in the project and an implementation assessment conducted after a period of implementation. The readiness assessment will help identify which, if any, technical components of the enhanced recovery after surgery intervention already exist at the hospital, project management and resources, clinician engagement, leadership engagement and potential barriers and facilitators to implementation. The implementation assessment will evaluate what elements of the enhanced recovery practices have been adopted, resources invested, team participation, major barriers (e.g., medications, equipment, trained personnel), and leadership participation. These assessments will help identify training needs of hospitals and inform the national team's approach. In addition, the results will inform the national team's understanding of local adaptations of the intervention and the degree to which intervention impacts changes in outcomes. (4) Site visits--Semi-structured site visits will be conducted at a subset of participating hospitals. Findings will help inform the national project implementation strategy. Information from these visits will be critical in understanding if and how team and/or leadership issues may affect implementation of enhanced recovery after surgery practices, including how this may differ across surgical services. Interviews will help uncover and clarify misalignments in roles, needed time and resources, best practices, and potential enablers of and barriers to enhanced recovery after surgery implementation. Site visits will be conducted at approximately 4 hospitals per year, and each will be 1-day long. The types of hospital personnel anticipated to be involved in part or all of the site visit include senior leadership, perioperative leadership, and patient safety and quality staff. Participating hospitals will receive a structured debriefing and brief summary report at the end of the one-day visit. 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 ---------------------------------------------------------------------------------------------------------------- Safety culture survey........................... 12,000 1 0.25 3,000 Patient experience survey....................... 1,800 1 0.37 666 Readiness and Implementation assessment......... 720 1 1 720 Site visits..................................... 40 1 8 320 --------------------------------------------------------------- Total....................................... 14,560 N/A N/A 4,706 ---------------------------------------------------------------------------------------------------------------- [[Page 22833]] Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Average Form name Number of Total burden hourly wage Total cost respondents hours rate * burden ---------------------------------------------------------------------------------------------------------------- Safety culture survey........................... 6,000 1,500 \a\ $101.04 $151,560 Safety culture survey........................... 6,000 1,500 \b\ 34.70 52,050 Patient experience survey....................... 1,800 666 \d\ 23.86 15,891 Readiness and Implementation assessment......... 360 360 \a\ 101.04 36,374 Readiness and Implementation assessment......... 360 360 \c\ 52.58 18,929 Site visits..................................... 20 160 \a\ 101.04 16,166 Site visits..................................... 20 160 \c\ 52.58 8,413 --------------------------------------------------------------- Total....................................... 14,560 4,706 N/A 299,383 ---------------------------------------------------------------------------------------------------------------- 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 29-1060 Physicians and Surgeons. \b\ Based on the mean wages for 29-1141 Registered Nurse. \c\ Based on the mean wages for 11-9111 Medical and Health Services Managers. \d\ Based on the mean wages for 00-0000 All Occupations. 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 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, Deputy Director. [FR Doc. 2017-10065 Filed 5-17-17; 8:45 am] BILLING CODE 4160-90-P
![Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Notices 22831
Service, National Institutes of Health, Beginning with this version, AHRQ will Reports Clearance Officer, AHRQ, by
National Library of Medicine, Office of no longer publish aggregate report email at doris.lefkowitz@AHRQ.hhs.gov.
the National Coordinator for Health specifications, which were initially Copies of the proposed collection
Information Technology, Office of provided for versions 1.0, 1.1, and 1.2 plans, data collection instruments, and
Public Health and Science, and as a local resource for providers, specific details on the estimated burden
Substance Abuse and Mental Health because the report specifications are no can be obtained from the AHRQ Reports
Services Administration—as well as the longer needed to guide providers Clearance Officer.
DoD and VA. regarding aggregating output. FOR FURTHER INFORMATION CONTACT:
Since the initial release of the The Common Formats for Event Doris Lefkowitz, AHRQ Reports
Common Formats in August 2008, Reporting—Hospital Version 2.0 Clearance Officer, (301) 427–1477, or by
AHRQ has regularly revised the formats constitutes a major release of the AHRQ email at doris.lefkowitz@AHRQ.hhs.gov.
based upon public comment. First, Common Formats and reflects these key SUPPLEMENTARY INFORMATION:
AHRQ reviews existing patient safety changes:
practices and event reporting systems. • Data elements are designated as Proposed Project
Then, AHRQ works in collaboration either ‘core’ or ‘supplemental’ for In accordance with the Paperwork
with the PSWG and Federal subject reporting purposes; Reduction Act, 44 U.S.C. 3501–3521,
matter experts to develop and draft the • Event descriptions for each module AHRQ invites the public to comment on
Common Formats. In addition, the are condensed; and this proposed information collection.
PSWG assists AHRQ with assuring the • Module-specific paper forms are
The AHRQ Safety Program for
consistency of definitions/formats with eliminated.
The formats have two tiers, or data Enhancing Surgical Care and Recovery
those of relevant government agencies. is a quality improvement project that
Next, AHRQ solicits feedback from sets. The first tier, or core data set,
contains elements that are collected for aims to provide technical assistance to
private sector organizations and hospitals to help them implement
individuals. Finally, based upon the submission at the national level to the
PSOPPC. The second tier, or evidence-based practices to improve
feedback received, AHRQ further revises
supplemental data set, is optional for outcomes and prevent complications
the Common Formats.
use at the local level to support among patients who undergo surgery.
Participation by the private sector in
the development and subsequent additional analyses, and is not required Enhanced recovery pathways are a
revision of the Common Formats is for transmission to the PSOPPC. All constellation of preoperative,
achieved through work with the NQF. documentation for the Common Formats intraoperative, and postoperative
The Agency engages the NQF, a non- for Event Reporting—Hospital Version practices that decrease complications
profit organization focused on health 2.0 is posted on the PSOPPC Web site. and accelerate recovery. A number of
care quality, to solicit comments and https://www.psoppc.org/psoppc_web. studies and meta-analyses have
advice regarding proposed versions of More information on the Common demonstrated successful results. In
the Common Formats. AHRQ began this Formats can be obtained through order to facilitate broader adoption of
process with the NQF in 2008, receiving AHRQ’s PSO Web site: http:// these evidence-based practices among
feedback on AHRQ’s 0.1 Beta release of www.pso.ahrq.gov/. U.S. hospitals, this AHRQ project will
the Common Formats for Event adapt the Comprehensive Unit-based
Sharon B. Arnold, Safety Program (CUSP), which has been
Reporting—Hospital. After receiving
public comment, the NQF solicits the Deputy Director. demonstrated to be an effective
review and advice of its Common [FR Doc. 2017–10068 Filed 5–17–17; 8:45 am] approach to reducing other patient
Formats Expert Panel and subsequently BILLING CODE 4160–90–P harms, to enhanced recovery after
provides feedback to AHRQ. The surgery. The approach uses a
Agency then revises and refines the combination of clinical and cultural
Common Formats and issues them as a DEPARTMENT OF HEALTH AND (i.e., technical and adaptive)
production version. AHRQ has HUMAN SERVICES intervention components, which
continued to employ this process for all include promoting leadership and
Agency for Healthcare Research and frontline staff engagement, close
subsequent versions of the Common
Quality teamwork among surgeons, anesthesia
Formats.
providers, and nurses, as well as
Common Formats for Event Reporting— Agency Information Collection
enhancing patient communication and
Hospital Version 2.0 Activities: Proposed Collection;
engagement. Interested hospitals will
Comment Request
On April 8, 2016, AHRQ announced voluntarily participate.
the availability of the Common Formats AGENCY: Agency for Healthcare Research This project has the following goals:
for Event Reporting—Hospital Version and Quality, HHS. • Improve outcomes of surgical patients
2.0 for review and comment in the ACTION: Notice. by disseminating and supporting
Federal Register (81 FR 20642–20643). implementation of evidence-based
At the time of the initial release of the SUMMARY: This notice announces the enhanced recovery practices within
formats, only the event descriptions— intention of the Agency for Healthcare the CUSP framework
which define adverse events of interest Research and Quality (AHRQ) to request • Develop a bundle of technical and
in the inpatient hospital setting—were that the Office of Management and adaptive interventions and associated
made available. Based on public Budget (OMB) approve the proposed
jstallworth on DSK7TPTVN1PROD with NOTICES
tools and educational materials to
comment and NQF Expert Panel advice, information collection project: ‘‘The support implementation
AHRQ updated the event descriptions AHRQ Safety Program for Enhancing • Provide technical assistance and
and developed additional Surgical Care and Recovery.’’ training to hospitals for implementing
documentation for the Common Formats DATES: Comments on this notice must be enhanced recovery practices
for Event Reporting—Hospital Version received by July 17, 2017. • Assess the adoption, and evaluate the
2.0, including data element definitions, ADDRESSES: Written comments should effectiveness of, the intervention
algorithms, and technical specifications. be submitted to: Doris Lefkowitz, among the participating hospitals
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EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate *
Safety culture survey ....................................................................................... 6,000 1,500 a $101.04 $151,560
Safety culture survey ....................................................................................... 6,000 1,500 b 34.70 52,050
Patient experience survey ............................................................................... 1,800 666 d 23.86 15,891
Readiness and Implementation assessment ................................................... 360 360 a 101.04 36,374
Readiness and Implementation assessment ................................................... 360 360 c 52.58 18,929
Site visits .......................................................................................................... 20 160 a 101.04 16,166
Site visits .......................................................................................................... 20 160 c 52.58 8,413
Total .......................................................................................................... 14,560 4,706 N/A 299,383
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 29–1060 Physicians and Surgeons.
b Based on the mean wages for 29–1141 Registered Nurse.
c Based on the mean wages for 11–9111 Medical and Health Services Managers.
d Based on the mean wages for 00–0000 All Occupations.
Request for Comments DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
HUMAN SERVICES Regulations.gov. Follow the instructions
In accordance with the Paperwork for submitting comments.
Reduction Act, comments on AHRQ’s Centers for Disease Control and • Mail: Leroy A. Richardson,
information collection are requested Prevention Information Collection Review Office,
with regard to any of the following: (a) Centers for Disease Control and
[60Day–17–17ADT; Docket No. CDC–2017–
Whether the proposed collection of 0046] Prevention, 1600 Clifton Road NE., MS–
information is necessary for the proper D74, Atlanta, Georgia 30329.
performance of AHRQ health care Proposed Data Collection Submitted Instructions: All submissions received
research and health care information for Public Comment and must include the agency name and
dissemination functions, including Recommendations Docket Number. All relevant comments
whether the information will have received will be posted without change
AGENCY: Centers for Disease Control and to Regulations.gov, including any
practical utility; (b) the accuracy of Prevention (CDC), Department of Health
AHRQ’s estimate of burden (including personal information provided. For
and Human Services (HHS). access to the docket to read background
hours and costs) of the proposed ACTION: Notice with comment period.
collection(s) of information; (c) ways to documents or comments received, go to
enhance the quality, utility, and clarity SUMMARY: The Centers for Disease Regulations.gov.
of the information to be collected; and Control and Prevention (CDC), as part of Please note: All public comment should be
(d) ways to minimize the burden of the its continuing efforts to reduce public submitted through the Federal eRulemaking
burden and maximize the utility of portal (Regulations.gov) or by U.S. mail to the
collection of information upon the
address listed above.
respondents, including the use of government information, invites the
automated collection techniques or general public and other Federal FOR FURTHER INFORMATION CONTACT: To
other forms of information technology. agencies to take this opportunity to request more information on the
comment on proposed and/or proposed project or to obtain a copy of
Comments submitted in response to continuing information collections, as the information collection plan and
this notice will be summarized and required by the Paperwork Reduction instruments, contact Leroy A.
included in the Agency’s subsequent Act of 1995. This notice invites Richardson, Information Collection
request for OMB approval of the comment on the proposed information Review Office, Centers for Disease
proposed information collection. All collection project titled ‘‘Who’s at Risk: Control and Prevention, 1600 Clifton
comments will become a matter of From Hazards to Communities—An Road NE., MS–D74, Atlanta, Georgia
public record. Approach for Operationalizing CDC 30329; phone: 404–639–7570; Email:
Sharon B. Arnold, Guidelines to Determine Risks, and omb@cdc.gov.
Define, Locate and Reach At-Risk SUPPLEMENTARY INFORMATION: Under the
Deputy Director.
Populations in Public Health Paperwork Reduction Act of 1995 (PRA)
[FR Doc. 2017–10065 Filed 5–17–17; 8:45 am] Emergencies.’’ The data collection will (44 U.S.C. 3501–3520), Federal agencies
BILLING CODE 4160–90–P include invitations to subject matter must obtain approval from the Office of
experts for public health and medical Management and Budget (OMB) for each
emergency planning. The data collection of information they conduct
collection efforts will include a focus or sponsor. In addition, the PRA also
group format and also investigate at-risk requires Federal agencies to provide a
jstallworth on DSK7TPTVN1PROD with NOTICES
population needs through an 60-day notice in the Federal Register
anonymous survey. concerning each proposed collection of
DATES: Written comments must be information, including each new
received on or before July 17, 2017. proposed collection, each proposed
ADDRESSES: You may submit comments, extension of existing collection of
identified by Docket No. CDC–2017– information, and each reinstatement of
0046 by any of the following methods: previously approved information
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Document Created: 2017-05-18 01:20:51
Document Modified: 2017-05-18 01:20:51
| 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 17, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 82 FR 22831 |
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