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.
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.
Form Form #4 Collection of documentation
AIR Response to OMB_08 13 09(MH)- .doc
Attachment G_60 Day FRN (3).pdf
Collection of documentation