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Agency Information Collection Activities: Proposed Collection; Comment Request

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Agency for Healthcare Research and Quality, HHS.




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: “Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP).” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on April 23rd and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.


Comments on this notice must be received by August 28, 2014.


Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at

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.

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Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at

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Proposed Project

Phase II of a Longitudinal Program Evaluation of Health and Human Services (HHS) Healthcare Associated Infections (HAI) National Action Plan (NAP)

This evaluation of HHS' Healthcare Associated Infections National Action Plan will assess the efficacy, efficiency and coordination of federal efforts to mitigate and prevent Healthcare Associated Infections (HAIs). As such, the evaluation represents a critical component of AHRQ's mission to promote health care quality improvement.

HAIs are infections that patients acquire while receiving treatment for other conditions while in a health care setting. They affect care in hospitals, -hereafter referred to as “acute care-,” ambulatory care settings, and long-term care facilities, and represent a significant cause of illness and death in the United States. Over one million HAIs occur across health care settings every year.

In 2008, amidst growing demands on the health care system, rising health care costs, and increasing concerns about antimicrobial-resistant pathogens, HHS established a senior-level Steering Committee for the Prevention of HAIs. Charged with improving coordination and maximizing the efficiency of prevention efforts across HHS, the Steering Committee released the first “National Action Plan to Prevent Health Care-Associated Infections” (HAI NAP) in 2009. This plan outlined a systematic and phased approach to reducing HAIs and associated morbidity, mortality, and costs. Phase One of HAI NAP, which concluded in 2012, focused on HAI prevention in acute care hospitals, where data on prevention and the capacity to measure improvement were most complete. Additionally, the plan set specific targets for reducing rates of six high priority HAIs or specific causative organisms: Surgical site infection (SSI), central-line associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP), catheter-associated urinary tract infection (CAUTI), Clostridium difficile infection, and methicillin-resistant Staphylococcus aureus infection (MRSA).

Phase II of the Action Plan, entitled National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination was released in April 2012. Phase 11 expanded the Action Plan to include prevention of HAIs in ambulatory surgical centers (ASCs) and end-stage renal disease (ESRD) facilities, and increasing influenza vaccination coverage of health care personnel. Phase III of the HAI NAP, released for public comment in April 2013, further expanded the Action Plan to include prevention of HAIs in long-term care facilities.

Evaluation of HAI NAP. In 2009, AHRQ funded an independent, outside evaluation of HHS' HAI prevention efforts, as guided by the Action Plan. The goals of this evaluation were to: (1) Record the content and scope of the Action Plan, its current design, its progress, and impact on the future; (2) establish baseline data and provide additional information on the HAT landscape prior to and following the initiation of the Action Plan effort; and (3) provide strategic insights from ongoing processes for reducing HAIs and outcomes of these processes.

The current evaluation will expand upon this initial effort, encompassing the additional health care settings outlined in Phases H and III of the HAI NAP.

The goals of this Phase II evaluation are to:

1. Identify commonalities, gaps, themes, and opportunities for collaboration across six Federal quality improvement and patient safety efforts to eliminate HAIs; and

2. highlight actionable opportunities across HHS to collaborate and efficiently utilize resources in these quality improvement and patient safety efforts; and

3. assess the unique and aggregate contributions of each quality improvement and patient safety effort to the mitigation and prevention of HAIs.

This study is being conducted by AHRQ through its contractor, Insight Policy Research, Inc. and its subcontractors, IMPAQ International and RAND Corporation, pursuant to AHRQ's statutory authority to conduct and support research and evaluations 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 Start Printed Page 44034services 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 the HAI NAP evaluation, the following data collections will be implemented:

Semi-structured interviews. Key informant interviews with stakeholders of the HAI National Action Plan or the Quality Improvement (QI) initiatives that the Action Plan seeks to coordinate and align. These stakeholders will have knowledge of the QI initiatives as implemented in acute care, ambulatory care, long-term care or ESRD facilities. AHRQ plans to conduct 33 interviews each year, over the course of two years. The semi-structured interviews will inform the process evaluation.

AHRQ will use the interview data to assess the processes and methods used, results achieved, and lessons learned from patient quality and safety programs that are directed at reducing the incidence of HAIs. This information will enable AHRQ to identify redundancies in program efforts and provide effective approaches for coordinating and aligning Federal efforts to prevent the incidence of HAIs. Finally, collecting data from these stakeholders will allow AHRQ to detect gaps in the HAI science base and opportunities for funding additional projects focused on generating and implementing knowledge on preventing HAIs.

The information gathered through the key informant interviews will be presented to members of a Federal Action Working Group (FAWG), comprising representatives from the various Federal agencies and operating divisions of MIS who are actively involved in the HAI NAP. Presentations to the FAWG will provide continual and rapid-cycle feedback on evaluation findings. This feedback will accomplish several goals—namely, it will apprise the FAWG members of the study's formative findings, provide a medium to obtain feedback from the FAWG regarding the unique and aggregate impact of the national programs, and engage the FAWG in a discussion about gaps and future requirements.

Ultimately, the information gathered through this data collection effort will appear in annual reports, along with results of secondary data analyses. These reports will provide AHRQ and HHS with comprehensive, evaluative findings across and within individual patient safety programs as well as findings specific to the HAI NAP, and the extent to which the goals outlined in the plan have been achieved.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in this evaluation. The total burden hours are estimated to be 66, which covers two years of interviews. The exhibits below indicate annualized burden hours in one year.

In-Depth Interviews with Stakeholders: AHRQ plans to conduct 33 semi-structured interviews each year for two years, totaling 66 semi-structured interviews during the course of the evaluation. These interviews will be conducted with key HAI NAP stakeholders with expertise in one or more of the four targeted health care settings. These health care settings include: acute care hospital settings, ambulatory surgical centers, ESRD facilities, and long-term care settings. Respondents will be interviewed by telephone. Participant recruitment should take no longer than five minutes. Scheduling will take place through email and will include an attached letter of support from AHRQ. Interviews will last up to one hour.

Exhibit 1—Estimated Annualized Burden Hours

Data collection activityNumber of respondents per yearNumber of responses per respondentHours per responseTotal burden hours
In-depth Interviews with HAI NAP Stakeholders with expertise pertaining to:9
• Acute Care Hospital Settings8119
• Ambulatory Surgical Centers8118
• ESRD facilities8118
• Long-Term Care Settings118

Exhibit 2—Estimated Annualized Cost Burden

Data collection activityNumber of respondentsTotal burden hoursAverage hourly wage rateTotal cost burden
In-depth Interviews with external stakeholders:
• Acute Care Hospital Settings99*$34.33$309.00
• Ambulatory Surgical Centers88*34.33275.00
• ESRD facilities88*34.33275.00
• Long-Term Care Settings88*34.33275.00
* Based upon May 2012 National Occupational Employment and Wage Estimates for Epidemiologists, retrieved from​oes/​current/​oesnat.htm#19-0000 on February 20, 2014.

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 Start Printed Page 44035enhance 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.

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Dated: July 15, 2014.

Richard Kronick,

AHRQ Director.

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[FR Doc. 2014-17660 Filed 7-28-14; 8:45 am]