82 FR 35210 - 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 | 35210-35212 | |
| FR Document | 2017-15886 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Notices] [Pages 35210-35212] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15886] ----------------------------------------------------------------------- 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 ``Expanding the Comprehensive Unit-based Safety Program (CUSP) to Reduce Central Line-Associated Blood Stream Infections (CLABSI) and Catheter-Associated Urinary Tract Infections (CAUTI) in Intensive Care Units (ICU) with Persistently Elevated Infection Rates.'' DATES: Comments on this notice must be received by September 26, 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 Expanding the Comprehensive Unit-Based Safety Program (CUSP) To Reduce Central Line-Associated Blood Stream Infections (CLABSI) and Catheter- Associated Urinary Tract Infections (CAUTI) in Intensive Care Units (ICU) With Persistently Elevated Infection Rates In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501- 3521, AHRQ invites the public to comment on this proposed information collection. Healthcare-associated infections, or HAIs, are a highly significant cause of illness and death for patients in the U.S. health care system. At any given time, HAIs affect one out of every 25 hospital inpatients. More than a million of these infections occur across our health care system every year, leading to significant patient harm and the annual loss of tens of thousands of lives, and costing billions of dollars each year. Some of the most prevalent HAIs include: Surgical site infections, catheter-associated urinary tract infections (CAUTI), central-line associated blood stream infections (CLABSI), and ventilator-associated pneumonia. It is estimated that CAUTIs affect approximately 250,000 hospital patients per year, and approximately 40,000 CLABSI cases occur annually with a mortality rate from 12 to 25 percent. From 2008-2012, AHRQ supported the National Implementation of the Comprehensive Unit-Based Safety Program (CUSP) to Reduce Central Line- Associated Blood Stream Infections (under an ACTION contract with the Health Research and Educational Trust (HRET), in partnership with Johns Hopkins University and the Michigan Hospital Association. From 2011- 2015, AHRQ expanded its CUSP efforts to include the national implementation of CUSP for CAUTI in hospitals across the United States. This effort was carried out under an ACTION II contract with HRET, in partnership with Johns Hopkins University and the Michigan Hospital Association. As part of the Department of Health and Human Services National Action Plan to Prevent Healthcare-Associated Infections, AHRQ has supported the implementation and adoption of the CUSP for CLABSI and CUSP for CAUTI, and is applying the principles and concepts that have been learned from these HAI reduction efforts to ICUs with persistently elevated infection rates. Results of Implementation of CUSP for CLABSI and CAUTI The nationwide CUSP for CLABSI project implemented CUSP with teams at more than 1,100 adult ICUs in 44 states over a 4-year period. ICUs participating in this project reduced the rate of CLABSIs nationally from 1.915 infections per 1,000 central line days to 1.133 infections per 1,000 line days, an overall reduction of 41 percent. However, not all ICUs performed equally well. The CUSP for CAUTI project implemented CUSP in nine cohorts, representing over 1,600 hospital units in over 1,200 hospitals located across 40 states, the District of Columbia, and Puerto Rico. Inpatient CAUTI rates in non-ICUs were decreased by 30%. However, CAUTI rates in ICUs were not reduced significantly. In other words, while the overall results of the implementation of CUSP for CLABSI and CUSP for CAUTI have shown remarkable progress, not all ICUs in the projects have achieved the intended rate reductions, nor have all ICUs participated in the two projects. Moreover, a significant number of institutions and ICUs continue to have persistently elevated infection rates. There are institutions that have varying rates of infections within the same institution, indicating that infection control is often a unit-based issue. In sum, despite the significant overall reductions in CLABSI and CAUTI rates that have been achieved in these two projects, there is evidence that ICUs have generally faced challenges in reducing CAUTI rates, and that many hospitals still are not where they should be in CLABSI rates. Modified approaches and strategies for the CUSP intervention need to be developed and implemented to reach ICUs with [[Page 35211]] persistently elevated CLABSI and CAUTI rates and help them succeed in preventing these infections. To address this need, AHRQ will launch this project aimed at spreading nationally implementation of an adaptation of CUSP for CLABSI and CAUTI for ICUs with persistently elevated rates, optimizing the approach to maximize effectiveness, and further preventing these infections throughout the United States. This project has the following goals:Reduce CLABSI and CAUTI in ICUs with persistently elevated rates. Revise and augment current CUSP training resources and materials for CUSP for CLABSI and CAUTI in ICUs with persistently elevated rates. The resulting toolkit will be intended for use in ICUs whose infection rates for either or both of these HAIs are persistently elevated compared to other ICUs. Recruit 450-600 ICUs with persistently elevated rates nationally to demonstrate the utility of applying a modified CUSP for CLABSI and CUSP for CAUTI during the performance period to reduce rates of CLABSI and CAUTI in these ICUs. Assess the adoption of the modified CUSP for CLABSI and CAUTI and evaluate the effectiveness of the intervention in the participating ICUs This study is being conducted by AHRQ through its contractor, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2). Method of Collection To achieve the goals of this project the following data collections will be implemented: (1) ICU Assessment Tool: The ICU assessment tool will be completed by the unit project team leader in collaboration with individuals with strong knowledge of current clinical and safety practices in the ICU, such as the ICU manager, infection preventionist, quality leader, clinical educator, or clinical nurse specialist. The purpose of this assessment is to understand current HAI prevention practices, policies, and procedures to tailor the educational program to meet the needs of the ICU. An assessment will be administered at the end of the program to monitor any changes in practices, policies, and procedures after program participation; the unit will receive an individualized report based on responses. (2) Team Checkup Tool: The unit team members (such as the ICU manager, quality leader, clinical educator, or clinical nurse specialist) will complete one Team Check-up Tool every month during the project period. The information collected will be used for coaching assistance by the unit project team leader. This tool helps assess unit strengths and opportunities for improving unit processes, procedures, and safety culture. This will be accomplished by the following steps: Hold a short, recurring meeting with the team to complete this tool and review the results. Randomly select staff from the unit to answer questions 1- 3. Staff selected should not exclusively include those completing this form. For statements where the `No' or `Don't Know' column is checked, review opportunities for improvement. Develop a Plan-Do-Study-Act (PDSA) plan and complete rapid cycles of improvement over the course of the month and reevaluate. (3) Site Visits: State leads and clinical mentors will coordinate state-level, in-person site visits for 50 percent of participating hospital units. Site visits are an opportunity for state leads and clinical mentors to meet with ICU teams and their leadership to strengthen relationships, engage in open discussion about infection prevention, and facilitate unit-specific changes through action planning. Site visit evaluation is based on the Site Visit Guidance and Action Planning Template. State leads will submit an action planning report to the project Web site within one week of the visit. This data collection effort will be part of a comprehensive evaluation strategy to assess the adoption of the Expansion of the Comprehensive Unit-Based Safety Program for CLABSI and CAUTI in ICUs with persistently elevated rates; measure the effectiveness of the interventions in the participating units; and evaluate the characteristics of teams that are associated with successful implementation and improvements in outcomes. The evaluation of this data collection is largely foundational in nature as AHRQ seeks information on the implementation and effectiveness of the CUSP for CLABSI and CAUTI in ICUs with persistently elevated rates. The evaluation of the tools above will utilize a pre-post design, comparing practices, policies and procedures before and after participating in the program. 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 ---------------------------------------------------------------------------------------------------------------- ICU Assessment Tool............................. 150 2 1.25 375 Team Checkup Tool............................... 150 12 .2 360 Site Visits..................................... 75 1 4 300 --------------------------------------------------------------- Total....................................... 375 N/A N/A 1,035 ---------------------------------------------------------------------------------------------------------------- Exhibit 2--Estimated Annualized Cost Burden ---------------------------------------------------------------------------------------------------------------- Average Form name Number of Total burden hourly wage Total cost respondents hours rate * burden ---------------------------------------------------------------------------------------------------------------- ICU Assessment Tool............................. 150 375 \a\ $52.58 $19,718 Team Checkup Tool............................... 150 360 \a\ 52.58 18,929 Site Visits..................................... 75 75 \b\ 27.87 2,090 150 \c\ 34.70 5,205 37.5 \a\ 52.58 1,972 [[Page 35212]] 37.5 \d\ 98.83 3,706 --------------------------------------------------------------- Total....................................... 375 1,035 N/A $51,620 ---------------------------------------------------------------------------------------------------------------- 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 11-9111 Medical and Health Services Managers. \b\ Based on the mean wages for 29-9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other. \c\ Based on the mean wages for 29-1141 Registered Nurse. \d\ Based on the mean wages for 29-1069 Physicians and Surgeons, 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. Sharon B. Arnold, Deputy Director. [FR Doc. 2017-15886 Filed 7-27-17; 8:45 am] BILLING CODE 4160-90-P
![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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![35212 Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN—Continued
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate *
37.5 d 98.83 3,706
Total .......................................................................................................... 375 1,035 N/A $51,620
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 11–9111 Medical and Health Services Managers.
b Based on the mean wages for 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical
Workers, All Other.
c Based on the mean wages for 29–1141 Registered Nurse.
d Based on the mean wages for 29–1069 Physicians and Surgeons, All other.
Request for Comments an opportunity for the public to 2. Email your request, including your
In accordance with the Paperwork comment on CMS’ intention to collect address, phone number, OMB number,
Reduction Act, comments on AHRQ’s information from the public. Under the and CMS document identifier, to
information collection are requested Paperwork Reduction Act of 1995 Paperwork@cms.hhs.gov.
with regard to any of the following: (a) (PRA), federal agencies are required to 3. Call the Reports Clearance Office at
Whether the proposed collection of publish notice in the Federal Register (410) 786–1326.
information is necessary for the proper concerning each proposed collection of FOR FURTHER INFORMATION CONTACT:
performance of AHRQ’s health care information, including each proposed William Parham at (410) 786–4669.
research and health care information extension or reinstatement of an existing SUPPLEMENTARY INFORMATION: Under the
dissemination functions, including collection of information, and to allow Paperwork Reduction Act of 1995 (PRA)
whether the information will have a second opportunity for public (44 U.S.C. 3501–3520), federal agencies
practical utility; (b) the accuracy of comment on the notice. Interested must obtain approval from the Office of
AHRQ’s estimate of burden (including persons are invited to send comments Management and Budget (OMB) for each
hours and costs) of the proposed regarding the burden estimate or any collection of information they conduct
other aspect of this collection of or sponsor. The term ‘‘collection of
collection(s) of information; (c) ways to
information, including the necessity and information’’ is defined in 44 U.S.C.
enhance the quality, utility and clarity
utility of the proposed information 3502(3) and 5 CFR 1320.3(c) and
of the information to be collected; and
collection for the proper performance of includes agency requests or
(d) ways to minimize the burden of the
the agency’s functions, the accuracy of requirements that members of the public
collection of information upon the
the estimated burden, ways to enhance submit reports, keep records, or provide
respondents, including the use of
the quality, utility, and clarity of the information to a third party. Section
automated collection techniques or
information to be collected; and the use 3506(c)(2)(A) of the PRA (44 U.S.C.
other forms of information technology.
Comments submitted in response to of automated collection techniques or 3506(c)(2)(A)) requires federal agencies
this notice will be summarized and other forms of information technology to to publish a 30-day notice in the
included in the Agency’s subsequent minimize the information collection Federal Register concerning each
request for OMB approval of the burden. proposed collection of information,
proposed information collection. All DATES: Comments on the collection(s) of including each proposed extension or
comments will become a matter of information must be received by the reinstatement of an existing collection
public record. OMB desk officer by August 28, 2017. of information, before submitting the
ADDRESSES: When commenting on the collection to OMB for approval. No
Sharon B. Arnold,
proposed information collections, comments were received in response to
Deputy Director. the 60-day comment period. To comply
please reference the document identifier
[FR Doc. 2017–15886 Filed 7–27–17; 8:45 am] with this requirement, CMS is
or OMB control number. To be assured
BILLING CODE 4160–90–P consideration, comments and publishing this notice that summarizes
recommendations must be received by the following proposed collection(s) of
the OMB desk officer via one of the information for public comment:
DEPARTMENT OF HEALTH AND 1. Type of Information Collection
following transmissions: OMB, Office of
HUMAN SERVICES Request: Extension of a currently
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax approved collection; Title of
Centers for Medicare & Medicaid
Number: (202) 395–5806 OR, Email: Information Collection: Conditions of
Services
OIRA_submission@omb.eop.gov. Participation for Community Mental
[Document Identifiers: CMS–10506] To obtain copies of a supporting Health Centers and Supporting
statement and any related forms for the Regulations; Use: On June 17, 2011, we
Agency Information Collection
asabaliauskas on DSKBBXCHB2PROD with NOTICES
proposed collection(s) summarized in proposed for the first time new
Activities: Submission for OMB this notice, you may make your request conditions of participation (CoPs) for
Review; Comment Request using one of following: community mental health centers
AGENCY: Centers for Medicare & 1. Access CMS’ Web site address at (CMHCs). We finalized it in the final
Medicaid Services, HHS. Web site address at https:// rule that published October 29, 2013 (78
ACTION: Notice. www.cms.gov/Regulations-and- FR 64604), with an effective date 12
Guidance/Legislation/ months after publication of the final
SUMMARY: The Centers for Medicare & PaperworkReductionActof1995/PRA- rule. These CoPs which are based on
Medicaid Services (CMS) is announcing Listing.html. criteria prescribed in law and are
VerDate Sep<11>2014 18:50 Jul 27, 2017 Jkt 241001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\28JYN1.SGM 28JYN1](https://thefederalregister.org/doc/82_FR_35354/page/3.svg)
Document Created: 2017-07-28 03:10:34
Document Modified: 2017-07-28 03:10:34
| 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 September 26, 2017. | |
| Contact | Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at [email protected] | |
| FR Citation | 82 FR 35210 |
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