This ICR is approved consistent with revised supporting statements, revised instruments, and AHRQ memos of 7/7/09 and 8/13/09. Furthermore, consistent with AHRQ communication of 9/2/09, AHRQ agrees to the following additional terms: (1)To the extent that the objective of this study is to observe LEAN in real-world settings, and to the extent that each site is allowed to establish its own goals, outcome measures, and evaluation plans, AHRQ will need to provide a fundamental level of quality control when the results of these studies are disclosed, whether through journal publications or otherwise. That will mean that prior to publication, AHRQ will need to assess the evaluations these sites have undertaken, assess the threats to external and internal validity, and acknowledge all limitations (e.g. if the site claims there is a business case for LEAN but they never collected data on costs, part of AHRQ's assessment of the site's evaluation will be that the results are not grounded on verifiable evidence, which AHRQ will then disclose as a study limitation). (2) For the prospective studies, AHRQ agrees to send OMB a briefing document shortly after site visit 1 has taken place which outlines the various goals and outcomes/measurements each site plans to undertake. This can be sent to OMB as a non-substantive change. (3) The current approval is only for those sites already selected. We understand that there are 2 additional study sites being negotiated. Once those negotiations have concluded, AHRQ agrees to send OMB a non-substantive change for those 2 sites. The justification for the 83C should identify what the 2 sites are and then provide a description of why they are good choices for this study. As discussed in AHRQ memos of 7/7/09 and 8/13/09, these sites should vary on the dimensions considered important in this study (e.g. late adopters vs early adopters) and provide diversity of study sites. (4) For the discussion guides, AHRQ agrees to add a further probing question to 4.1. If the respondent says that they are not, for example, planning to assess improvements in efficiency, patient safety, cost, etc., then the questioner should ask why not. For site visit #2, AHRQ agrees that the interviewer should be prepared to first ask the general question in 3.1 about how the site defines success and a general question about impacts but to probe the respondents to the extent those goals, outcomes, or criteria for success do not match up to what was said in the first site visit. As such, the interviewer should be prepared for the site visit #2 with the response from site visit #1 in hand.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
09/30/2011
24 Months From Approved
584
0
0
322
0
0
0
0
0
AHRQ proposes to investigate the contribution of Lean/TPS to reducing waste in health care delivery systems. Lean/TPS is a process-redesign methodology adopted from Toyota Production Systems. The goal of Lean/TPS is to empower front-line staff to apply continuous quality improvement methods to reduce waste and enhance value in workflows and operations (Spear, S. Fixing healthcare from the inside, today. Harvard Business Rev., 2005 83(9), 78-91). AHRQ is interested in assessing and disseminating promising techniques and methodologies for redesigning health care processes to reduce waste and enhance efficiency. Using a purposive sample of health care organizations and projects, AHRQ will describe and assess the ways in which Lean/TPS has been implemented and the related challenges and solutions experienced. The sampled organizations will vary in community and market characteristics, type of service (e.g., inpatient/outpatient), and delivery system characteristics (e.g., relationship between physicians and hospitals, ownership). AHRQ plans to disseminate the lessons learned from this project on the implementation of Lean/TPS to health care delivery systems. AHRQ will work with a contractor to complete this work, including all activities mentioned above. This project is being performed pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on healthcare delivery systems, including activities with respect to: the quality, effectiveness, efficiency, appropriateness and value of health care services; quality measurement and improvement; and health care costs, productivity, organization, and market forces. 42 U.S.C.
US Code:
42 USC 299
Name of Law: Healthcare Research and Quality Act of 1999
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Collection of documentation