[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6631-6634]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-2680]


-----------------------------------------------------------------------

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: ``Reducing Waste and Inefficiency through Process Redesign: 
Lean/Toyota Production System (TPS) Implementation.'' In accordance 
with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ 
invites the public to comment on this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on November 21, 2008 and allowed 60 days for 
public comment. No comments were received. The purpose

[[Page 6632]]

of this notice is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by March 12, 2009.

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 
e-mail at [email protected] (attention: AHRQ's desk 
officer).
    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 e-mail at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

    ``Reducing Waste and Inefficiency through Process Redesign: Lean/
Toyota Production System (TPS) Implementation''
    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. 299a(a)(1), 
(2), and (6).

Method of Collection

    Four or five research locations (i.e., hospitals or other heath 
settings) will be selected to create nine case study reports. Four of 
the studies will employ a retrospective analytics perspective, while 
five will employ a prospective analytics perspective, including one 
study focused on the construction of a hospital. For the other eight 
case studies, the department will be unit of analysis for the case 
study. At each research location, implementation of Lean/TPS in two 
departments will be studied: One department with an essentially linear 
process (clinical laboratory, radiology, or ED) and one department with 
an essentially non-linear process (cardiology, GI, or med/surg unit). A 
linear department is one in which the process is essentially uniform 
and predictable for most or all services delivered. A non-linear 
department is one in which the process is much less uniform and 
predictable.
    Qualitative data will be collected directly from the departments 
selected for this study. The collection will be accomplished using 
interviews (telephone and in-person), collection of documentation, and 
digital diaries for the five prospective case studies. The ``digital 
diary'' is a data collection method using a diary entry guide and a 
digital recorder to describe key aspects of the implementation process. 
The number of digital diary submissions will depend on the number and 
duration of the Lean/TPS projects within in each department. The in-
person interviews will be conducted through a multi-day visit to each 
site. Only the in-person interviews and collection of documentation 
methods will be employed for the retrospective case studies.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours. The table 
includes burden for both the retrospective and prospective case studies 
in separate sections. As this project will collect data from 
establishments, we have defined each establishment as the medical or 
administrative department that is implementing the Lean/TPS project to 
be studied.
    In Exhibit 1, the total burden hours in each row (Column F) is 
calculated as the product of the values in the other colunms (Columns 
B-E). Thus, for each of the 5 prospective case studies, we will conduct 
in-person interviews with 15 administrative and clinical personnel. 
Each person will be interviewed twice during the 36 week data 
collection period. The estimated time per response is 1.0 hour for a 
total of 150 burden hours for in-person interviews. Using the same 
calculation approach, we project 23 burden hours for telephone 
interviews, 53 burden hours for digital diaries, and 20 burden hours 
for assembling documents for a subtotal of 246 burden hours for the 5 
prospective case studies. For each retrospective case study, we have 
defined establishment as the department from which we will collect 
data. A total of 15 in-person interviews will be conducted with the 
administrative and clinical personnel during a site visit. The 
estimated time per response is 1.0 hour. For all 4 retrospective case 
studies, we estimate a total of 60 burden hours. Similar to the 
prospective case studies, administrative staff from each site will be 
asked to provide training materials, reports on Lean/TPS 
implementation, and/or any other documentation or existing data from 
previous or current Lean/TPS projects implemented and will take 4 
hours. The total estimated burden for the retrospective case studies is 
76 hours. The total burden hours for all 9 case studies is 322 hours.
    Exhibit 2 shows the estimated annualized cost burden for the 
respondents' time to provide the requested data. The hourly rate of 
$35.07 is an average of the administrative personnel hourly wage of 
$14.53 and the clinical personnel hourly wage of $62.52 for physicians 
and $28.15 for registered nurses. The average hourly wage of 
administrative and clinical personnel is used to estimate the cost of 
in-person interviews, telephone interviews, and digital diaries, 
because all kinds of staff may be asked to participate in these three 
activities. The average hourly wage for administrative personnel--
$14.53--is used to estimate the cost of assembling documentation, 
because administrative support staff will perform this task. The total 
estimated cost burden is about $10,554.

[[Page 6633]]



                                                      Exhibit 1--Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of         Number of
                        Data collection                             Number of      respondents per    responses per       Hours per       Total burden
                                                                 establishments     establishment      respondent         response            hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
A                                                                              B                 C                 D                 E                 F
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Prospective Case Studies & Hospital Case Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-person interviews..........................................                 5                15                 2                 1               150
Telephone interviews..........................................                 5                 3                 3             30/60                23
Digital Diaries...............................................                 5                 2                32             10/60                53
Collection of documentation...................................                 5                 1                 1                 4                20
    Prospective Subtotal......................................                20               n/a               n/a               n/a               246
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Retrospective Case Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-person interviews..........................................                 4                15                 1                 1                60
Collection of documentation...................................                 4                 1                 1                 4                60
    Retrospective Subtotal....................................                 8               n/a               n/a               n/a                76
                                                               -----------------------------------------------------------------------------------------
        Grand Total...........................................                28               n/a               n/a               n/a               322
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                              Number of       Total burden     Average  hourly     Total cost
             Data collection               establishments         hours          wage rate*          burden
----------------------------------------------------------------------------------------------------------------
                               Prospective, Retrospective, & Hospital Case Studies
----------------------------------------------------------------------------------------------------------------
In-person interviews....................                 9               210            $35.07            $7,365
Telephone interviews....................                 5                23             35.07               807
Digital Diaries.........................                 5                53             35.07             1,859
Collection of documentation.............                 9                36             14.53               523
    Total...............................                28               322               n/a            10,554
----------------------------------------------------------------------------------------------------------------
*Based upon the average hourly wages of administrative support personnel, physicians, and registered nurses,
  National Compensation Survey: Occupational Wages in the United States 2005, U.S. Department of Labor, Bureau
  of Labor Statistics.

Estimated Annual Costs to the Federal Government

    The total cost to the Federal Government for this project is 
$494,999, with an average annual cost of $247,500. This figure includes 
the cost of data collection, data analysis, reporting, and contract 
oversight by the government. Exhibit 3 shows the individual cost 
components.

                        Exhibit 3--Estimated Cost
------------------------------------------------------------------------
           Cost component                Total cost      Annualized cost
------------------------------------------------------------------------
Project Development.................           $19,885            $9,942
Data Collection Activities..........           231,339           115,670
Data Processing and Analysis........            62,621            31,310
Publication of Results..............            67,087            33,544
Project Management..................            21,349            10,675
Overhead............................            77,532            38,766
Government Oversight................            15,186             7,593
                                     -----------------------------------
    Total...........................           494,999           247,500
------------------------------------------------------------------------

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, comments on AHRQs 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.


[[Page 6634]]


    Dated: February 2, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-2680 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-90-M