82 FR 35208 - 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 144 (July 28, 2017)
Agency for Healthcare Research and Quality
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35208-35210 | |
| FR Document | 2017-15885 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Notices] [Pages 35208-35210] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15885] ----------------------------------------------------------------------- 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 Surgical Care and Recovery.'' This proposed information collection was previously published in the Federal Register titled ``The AHRQ Safety Program for Enhancing Surgical Care and Recovery,'' on May 18, 2017 and allowed 60 days for public comment. AHRQ did not receive any substantive comments. The purpose of this notice is to allow an additional 30 days for public comment. DATES: Comments on this notice must be received by August 28, 2017. 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 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 Improving 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 of surgical patients. 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. 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 Improving 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 adapted 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 [[Page 35209]] 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 who were treated 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 surgical care and recovery 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 fidelity 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 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 surgical care and recovery 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 being 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 ---------------------------------------------------------------------------------------------------------------- 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. [[Page 35210]] \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. 2017-15885 Filed 7-27-17; 8:45 am] BILLING CODE 4160-90-P
![35208 Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN FOR THE 2018–2019 MEPS–IC—Continued
Average
Number of Total burden Total cost
Form name hourly
respondents hours burden
wage rate *
Total .......................................................................................................... 78,898 22,952 na 733,776
* Based upon the mean hourly wage for Compensation, Benefits, and Job Analysis Specialists occupation code 13–1141, at https://
www.bls.gov/oes/current/oes131141.htm (U.S. Department of Labor, Bureau of Labor Statistics.)
Request for Comments This proposed information collection promoting leadership and frontline staff
was previously published in the Federal engagement, close teamwork among
In accordance with the Paperwork
Register titled ‘‘The AHRQ Safety surgeons, anesthesia providers, and
Reduction Act, comments on AHRQ’s
Program for Enhancing Surgical Care nurses, as well as enhancing patient
information collection are requested
and Recovery,’’ on May 18, 2017 and communication and engagement.
with regard to any of the following: (a)
allowed 60 days for public comment. Interested hospitals will voluntarily
Whether the proposed collection of
AHRQ did not receive any substantive participate.
information is necessary for the proper This project has the following goals:
comments. The purpose of this notice is
performance of AHRQ health care • Improve outcomes of surgical
to allow an additional 30 days for public
research and health care information patients by disseminating and
comment.
dissemination functions, including supporting implementation of evidence-
whether the information will have DATES: Comments on this notice must be
received by August 28, 2017. based enhanced recovery practices
practical utility; (b) the accuracy of within the CUSP framework.
AHRQ’s estimate of burden (including ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk • Develop a bundle of technical and
hours and costs) of the proposed adaptive interventions and associated
collection(s) of information; (c) ways to Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by tools and educational materials to
enhance the quality, utility, and clarity support implementation.
of the information to be collected; and email at OIRA_submission@
omb.eop.gov (attention: AHRQ’s desk • Provide technical assistance and
(d) ways to minimize the burden of the training to hospitals for implementing
collection of information upon the officer).
enhanced recovery practices.
respondents, including the use of FOR FURTHER INFORMATION CONTACT: • Assess the adoption, and evaluate
automated collection techniques or Doris Lefkowitz, AHRQ Reports the effectiveness of, the intervention
other forms of information technology. Clearance Officer, (301) 427–1477, or by among the participating hospitals.
Comments submitted in response to email at doris.lefkowitz@AHRQ.hhs.gov. This project is being conducted by
this notice will be summarized and SUPPLEMENTARY INFORMATION: AHRQ through its contractor Johns
included in the Agency’s subsequent Hopkins University; with subcontractors
request for OMB approval of the Proposed Project
Westat, and the American College of
proposed information collection. All In accordance with the Paperwork Surgeons. The AHRQ Safety Program for
comments will become a matter of Reduction Act, 44 U.S.C. 3501–3521, Improving Surgical Care and Recovery
public record. AHRQ invites the public to comment on is being undertaken pursuant to AHRQ’s
Sharon B. Arnold, this proposed information collection. mission to enhance the quality,
Deputy Director.
The AHRQ Safety Program for appropriateness, and effectiveness of
Improving Surgical Care and Recovery health services, and access to such
[FR Doc. 2017–15884 Filed 7–27–17; 8:45 am]
is a quality improvement project that services, through the establishment of a
BILLING CODE 4160–90–P
aims to provide technical assistance to broad base of scientific research and
hospitals to help them implement through the promotion of improvements
evidence-based practices to improve in clinical and health systems practices,
DEPARTMENT OF HEALTH AND
outcomes and prevent complications including the prevention of diseases and
HUMAN SERVICES
among patients who undergo surgery. other health conditions. 42 U.S.C. 299.
Agency for Healthcare Research and Enhanced recovery pathways are a
constellation of preoperative, Method of Collection
Quality
intraoperative, and postoperative To achieve the goals of this project the
Agency Information Collection practices that decrease complications following data collections will be
Activities: Proposed Collection; and accelerate recovery. A number of implemented:
Comment Request studies and meta-analyses have (1) Safety Culture Survey. Hospitals
demonstrated successful results. In will assess the impact of participation in
AGENCY: Agency for Healthcare Research order to facilitate broader adoption of the project on perioperative safety
and Quality, HHS. these evidence-based practices among culture by having their staff members
ACTION: Notice. U.S. hospitals, this AHRQ project will who will be part of the enhanced
asabaliauskas on DSKBBXCHB2PROD with NOTICES
adapt the Comprehensive Unit-based recovery program complete a survey
SUMMARY: This notice announces the Safety Program (CUSP), which has been adapted from the AHRQ Surveys on
intention of the Agency for Healthcare demonstrated to be an effective Patient Safety Culture (SOPS) at the
Research and Quality (AHRQ) to request approach to reducing other patient beginning and end of the program. The
that the Office of Management and harms, to enhanced recovery of surgical hospital’s enhanced recovery project
Budget (OMB) approve the proposed patients. The approach uses a team will receive their survey results
information collection project: ‘‘The combination of clinical and cultural and then debrief their staff on their
AHRQ Safety Program for Improving (i.e., technical and adaptive) safety culture and identify opportunities
Surgical Care and Recovery.’’ intervention components which include for further improvement. The national
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![35210 Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
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 DATES: Comments on this notice must be include the national implementation of
received by September 26, 2017. CUSP for CAUTI in hospitals across the
In accordance with the Paperwork United States. This effort was carried
Reduction Act, comments on AHRQ’s ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz, out under an ACTION II contract with
information collection are requested HRET, in partnership with Johns
with regard to any of the following: (a) Reports Clearance Officer, AHRQ, by
email at doris.lefkowitz@AHRQ.hhs.gov. Hopkins University and the Michigan
Whether the proposed collection of Hospital Association.
information is necessary for the proper Copies of the proposed collection
plans, data collection instruments, and As part of the Department of Health
performance of AHRQ health care and Human Services National Action
research and health care information specific details on the estimated burden
can be obtained from the AHRQ Reports Plan to Prevent Healthcare-Associated
dissemination functions, including Infections, AHRQ has supported the
whether the information will have Clearance Officer.
implementation and adoption of the
practical utility; (b) the accuracy of FOR FURTHER INFORMATION CONTACT:
CUSP for CLABSI and CUSP for CAUTI,
AHRQ’s estimate of burden (including Doris Lefkowitz, AHRQ Reports and is applying the principles and
hours and costs) of the proposed Clearance Officer, (301) 427–1477, or by concepts that have been learned from
collection(s) of information; (c) ways to email at doris.lefkowitz@AHRQ.hhs.gov. these HAI reduction efforts to ICUs with
enhance the quality, utility, and clarity SUPPLEMENTARY INFORMATION: persistently elevated infection rates.
of the information to be collected; and
Proposed Project Results of Implementation of CUSP for
(d) ways to minimize the burden of the
collection of information upon the Expanding the Comprehensive Unit- CLABSI and CAUTI
respondents, including the use of Based Safety Program (CUSP) To The nationwide CUSP for CLABSI
automated collection techniques or Reduce Central Line-Associated Blood project implemented CUSP with teams
other forms of information technology. Stream Infections (CLABSI) and at more than 1,100 adult ICUs in 44
Comments submitted in response to Catheter-Associated Urinary Tract states over a 4-year period. ICUs
this notice will be summarized and Infections (CAUTI) in Intensive Care participating in this project reduced the
included in the Agency’s subsequent Units (ICU) With Persistently Elevated rate of CLABSIs nationally from 1.915
request for OMB approval of the Infection Rates infections per 1,000 central line days to
proposed information collection. All 1.133 infections per 1,000 line days, an
In accordance with the Paperwork
comments will become a matter of overall reduction of 41 percent.
Reduction Act, 44 U.S.C. 3501–3521,
public record. However, not all ICUs performed
AHRQ invites the public to comment on
equally well.
Sharon B. Arnold, this proposed information collection. The CUSP for CAUTI project
Deputy Director. Healthcare-associated infections, or implemented CUSP in nine cohorts,
[FR Doc. 2017–15885 Filed 7–27–17; 8:45 am]
HAIs, are a highly significant cause of representing over 1,600 hospital units in
illness and death for patients in the U.S. over 1,200 hospitals located across 40
BILLING CODE 4160–90–P
health care system. At any given time, states, the District of Columbia, and
HAIs affect one out of every 25 hospital Puerto Rico. Inpatient CAUTI rates in
DEPARTMENT OF HEALTH AND inpatients. More than a million of these non-ICUs were decreased by 30%.
HUMAN SERVICES infections occur across our health care However, CAUTI rates in ICUs were not
system every year, leading to significant reduced significantly.
Agency for Healthcare Research and patient harm and the annual loss of tens In other words, while the overall
Quality of thousands of lives, and costing results of the implementation of CUSP
billions of dollars each year. Some of for CLABSI and CUSP for CAUTI have
Agency Information Collection the most prevalent HAIs include: shown remarkable progress, not all ICUs
Activities: Proposed Collection; Surgical site infections, catheter- in the projects have achieved the
Comment Request associated urinary tract infections intended rate reductions, nor have all
(CAUTI), central-line associated blood ICUs participated in the two projects.
AGENCY:Agency for Healthcare Research stream infections (CLABSI), and Moreover, a significant number of
and Quality, HHS. ventilator-associated pneumonia. It is institutions and ICUs continue to have
ACTION: Notice. estimated that CAUTIs affect persistently elevated infection rates.
approximately 250,000 hospital patients There are institutions that have varying
SUMMARY: This notice announces the per year, and approximately 40,000 rates of infections within the same
intention of the Agency for Healthcare CLABSI cases occur annually with a institution, indicating that infection
Research and Quality (AHRQ) to request mortality rate from 12 to 25 percent. control is often a unit-based issue.
that the Office of Management and From 2008–2012, AHRQ supported In sum, despite the significant overall
Budget (OMB) approve the proposed the National Implementation of the reductions in CLABSI and CAUTI rates
asabaliauskas on DSKBBXCHB2PROD with NOTICES
information collection project Comprehensive Unit-Based Safety that have been achieved in these two
‘‘Expanding the Comprehensive Unit- Program (CUSP) to Reduce Central Line- projects, there is evidence that ICUs
based Safety Program (CUSP) to Reduce Associated Blood Stream Infections have generally faced challenges in
Central Line-Associated Blood Stream (under an ACTION contract with the reducing CAUTI rates, and that many
Infections (CLABSI) and Catheter- Health Research and Educational Trust hospitals still are not where they should
Associated Urinary Tract Infections (HRET), in partnership with Johns be in CLABSI rates. Modified
(CAUTI) in Intensive Care Units (ICU) Hopkins University and the Michigan approaches and strategies for the CUSP
with Persistently Elevated Infection Hospital Association. From 2011–2015, intervention need to be developed and
Rates.’’ AHRQ expanded its CUSP efforts to implemented to reach ICUs with
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Document Created: 2017-07-28 03:10:05
Document Modified: 2017-07-28 03:10:05
| 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 August 28, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 82 FR 35208 |
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