[Federal Register Volume 75, Number 110 (Wednesday, June 9, 2010)]
[Notices]
[Pages 32783-32786]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13728]


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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.

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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: ``Spreading Techniques To Radically Reduce Antibiotic 
Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or 
MRSA).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 
3501-3520, AHRQ invites the public to comment on this proposed 
information collection.
    This proposed information collection was previously published in 
the Federal Register on November 25th, 2009 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.

DATES: Comments on this notice must be received by July 9, 2010.

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 <a href="/cdn-cgi/l/email-protection#5817110a19072b2d3a35312b2b3137361837353a763d3728763f372e"><span class="__cf_email__" data-cfemail="07484e5546587472656a6e74746e686947686a652962687729606871">[email protected]</span></a> (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: Dons Lefkowitz, AHRQ Reports Clearance 
Officer, (301) 427-1477, or by e-mail at <a href="/cdn-cgi/l/email-protection#71151e0318025f1d14171a1e0618050b31303923205f1919025f161e07"><span class="__cf_email__" data-cfemail="f1959e839882df9d94979a9e8698858bb1b0b9a3a0df999982df969e87">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

[[Page 32784]]

Proposed Project

Spreading Techniques To Radically Reduce Antibiotic Resistant Bacteria 
(Methicillin Resistant Staphylococcus aureus, or MRSA)

    Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths 
among the 2.1 million people who acquired infections while hospitalized 
in 2000, and HAI rates have risen relentlessly since then. Alarmingly, 
70% of HAIs are due to bacteria that are resistant to commonly used 
antibiotics, with Methicillin Resistant Staphylococcus aureus (MRSA) 
being the most rapidly growing, and among the most virulent, pathogens. 
Resistance is increasing rapidly in all types of hospitals (Huang 
2007). Despite evidence that routinely applied, simple interventions do 
work, most hospitals have failed to make notable progress in reducing 
MRSA infections. Hospitals in some European countries and select U.S. 
hospitals, however, have succeeded with impressive results.
    Sites that have already achieved dramatic decreases in their MRSA 
infection rates have done so by implementing precautions to prevent 
transmission, using system redesign approaches. Further, many hospitals 
have successfully instituted isolation procedures for patients 
suspected to be MRSA carriers. In doing so, these hospitals have 
followed the broadly disseminated guidelines for hand hygiene and 
contact isolation precautions. This study is a follow up to a recent 
study implemented in 6 hospital systems in the Indianapolis 
metropolitan area that used a ``MRSA intervention bundle'' composed of 
active surveillance screening, contact isolation precautions, and 
increased hand hygiene. Preliminary data from that initial study 
suggest a 60% decrease in MRSA rates in participating intensive care 
units (ICUs) (Doebbeling, B. Redesigning Hospital Care for Quality and 
Efficiency Applications of Positive Deviance and Lean in Reducing MRSA. 
Presentation at AHRQ Annual Meeting, Rockville, MD. Sept 2009).
    This project, a case study, will utilize the same guidelines and 
precautions that were applied in the original study, and will add an 
innovative feature that will use electronic medical record systems to 
improve identifying, communicating and tracking MRSA infections among 
healthcare systems. More specifically, this study has five aims:
    (1) Further test the ``MRSA intervention bundle'' from the original 
Indianapolis MRSA study, and test the intervention in additional units 
in the 4 original Indianapolis hospital systems and an additional 3 
hospital systems beyond Indianapolis;
    (2) Identify and monitor healthcare associated community onset 
(HACO) MRSA cases and controls who receive care in participating 
hospitals and affiliated settings, identify strategies to reduce HACO 
MRSA and demonstrate reduction of HACO MRSA;
    (3) Assess the relative effectiveness of various antibiotics in 
abatement or eradication of MRSA carriage in hospital patients;
    (4) Evaluate the effectiveness of the tested implementation 
strategies and innovations by applying information technology to enable 
consistent collection, sharing, analysis and reporting of data;
    (5) Disseminate findings and promote outreach to target audiences 
and other stakeholders.
    While many secondary data are available for this study, Aims 1 and 
2 involve primary data collection. Use of the intervention bundle 
requires that opinion leaders and front line workers be equipped with 
techniques used in the reorganization of healthcare delivery to improve 
health outcomes (Singhal and Greiner, 2007; IHI, 2005). These 
techniques will assist in identifying goals, implementing the 
interventions to meet local needs and measuring and feeding back 
progress on key processes and outcomes to staff and others.
    The study also incorporates an additional informatics surveillance 
system to allow participating hospitals to more efficiently 
communicate, share and track MRSA infections. This system will save 
infection control and clinicians' time-for example, by electronically 
identifying patients with a known history of drug-resistant infections 
when they first contact a new institution.
    This study is being conducted by AHRQ through its contractor, 
Indiana University and the Regenstrief Institute, pursuant to AHRQ's 
statutory authority to conduct and support research on healthcare and 
on systems for the delivery of such care, including activities with 
respect to the quality, effectiveness, efficiency, appropriateness and 
value of healthcare services and with respect to quality measurement 
and improvement. 42 U.S.C. 299a(a)(1) and (2).

Method of Collection

    To achieve the aims of this project the following data collections 
will be implemented:
    <bullet> Electronic medical record data on MRSA infections and 
screening rates will be collected from an existing and unique 
healthcare information exchange (Indiana Network for Patient Care or 
INPC) in the Indianapolis area, and the CDC's National Healthcare 
Safety Network (Aims 1-5). This data will be used to calculate the rate 
of MRSA Nosocomial Bloodstream Infections among individuals admitted to 
the project units at all seven participating hospitals. Screening rates 
for MRSA at time of admission and at discharge or transfer will also be 
collected on project units. This data will be used to evaluate the 
impact of the intervention on infection rates within the participating 
hospital units.
    <bullet> Observational data on hand washing will be collected for 
at least three hours each week per hospital (Aims 1, 2, and 4). 
Observations will be conducted in 10-minute blocks per patient 
selected. In total, 18 observations per hospital will be conducted each 
week. Hand hygiene rates will be based on observing the number of 
opportunities for hand hygiene and the number of actual times 
completing hand hygiene. Hand hygiene opportunities include when a 
provider enters a patient room, moves from a contaminated site to a 
clean site, helps with an invasive procedure, or leaves a patient room.
    <bullet> Social Network Analysis (SNA) Questionnaire, will be 
administered twice, pretest and posttest, to about 75 healthcare 
workers with direct patient care on project units (Aims 1, 4, and 5). 
The purpose of this questionnaire is to reveal the communicative 
patterns of complex groups and teams in order to identify: (1) The 
strength and frequency of the connections between members, (2) the 
level of knowledge members have concerning the structure of the 
network, and (3) the evaluation by members concerning the overall 
success of the network.
    <bullet> Culture Questionnaire will also be administered twice, 
pretest and posttest, to about 75 healthcare workers with direct 
patient care (Aims 1, 4, and 5). The purpose of this questionnaire is 
to understand the cultural beliefs, attitudes, and knowledge of the 
hospital staff.
    <bullet> Implementation Assessment Interviews of key informants 
will be conducted with about 4 individuals on the implementation team 
at each hospital and will be conducted quarterly (Aims 1, 4, and 5). 
This will allow the project team to understand and monitor how the 
intervention is proceeding on project units. By monitoring progress, 
the barriers and facilitators that could affect the project 
implementation can be identified.

[[Page 32785]]

    <bullet> Patient Healthcare Use Questionnaire will be mailed to a 
sample of patients from the 7 participating hospitals (Aims 2 and 4). 
The purpose of this survey is to identify risk factors for developing 
healthcare associated community onset (HACO) MRSA infections during a 
12-month period after discharge from a healthcare facility.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours associated 
with the hospital's time to participate in this research. Electronic 
medical record data will be collected weekly from 7 participating 
hospitals, however only two of these hospitals will use their staff to 
perform this data collection. Over the course of the project electronic 
medical record data will be extracted 52 times and each data extraction 
will take about 10 hours. Observational data will be collected 18 times 
each week from all participating hospitals, however only 3 hospitals 
will use their staff to perform the observations. The project will 
require 52 weeks of observations per hospital and will last 10 minutes 
per observation.
    Both the social network analysis questionnaire and the culture 
questionnaire will be administered twice, pretest and posttest, to 
about 75 personnel at each of the 7 hospitals. The social network 
analysis questionnaire will take about 15 minutes to complete while the 
culture questionnaire will take 30 minutes. The implementation 
assessment questionnaire will be administered quarterly to 3 key 
informants at each hospital and will take about one hour.
    The patient healthcare use questionnaire will be completed by 200 
patients sampled from the 7 participating hospitals. Each patient will 
respond once which will require about 15 minutes. The total annualized 
burden hours for all the associated data collections are estimated to 
be 2,458.
    Exhibit 2 shows the estimated annualized cost burden associated 
with the respondents' time to participate in this research. The total 
annual cost burden is estimated to be $77,387.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                     hospitals       hospital        response          hours
----------------------------------------------------------------------------------------------------------------
Electronic Medical Record Data Collection.......               2              52              10           1,040
Observational Data Collection...................               3             936           10/60             468
Social Network Analysis Questionnaire...........               7             150           15/60             263
Culture Questionnaire...........................               7             150           30/60             525
Implementation Assessment Interviews............               7              16               1             112
Patient Healthcare Use Questionnaire............             200               1           15/60              50
                                                 ---------------------------------------------------------------
    Total.......................................             226              na              na           2,458
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                        hospitals         hours       wage rate \*\      burden
----------------------------------------------------------------------------------------------------------------
Electronic Medical Record Data Collection.......               2            1040          $30.03         $31,231
Observational Data Collection...................               3             468           20.98           9,819
Social Network Analysis Questionnaire...........               7             263           38.28          10,068
Culture Questionnaire...........................               7             525           38.28          20,097
Implementation Assessment Interviews............               7             112           45.33           5,077
Patient Healthcare Use Questionnaire............             200              50           21.90           1,095
                                                 ---------------------------------------------------------------
    Total.......................................             226           2,458              na          77,387
----------------------------------------------------------------------------------------------------------------
\*\ Based upon the mean of the average wages for Nursing Care Providers ($30.03), Primary Care Physicians
  ($84.97), Allied Health Providers ($20.98), Administrators, Chief Executives ($76.23) and All Workers
  ($21.90); National Compensation Survey: Occupational wages in the United States May 2008, ``U.S. Department of
  Labor, Bureau of Labor Statistics.''

Estimated Annual Costs to the Federal Government

    Exhibit 3 shows the total and annualized cost of this project to 
the Federal Government over a two-year period. The total cost of this 
project is $1.8 million which includes $785,000 for project 
development, $70,000 for data collection activities, $235,000 for data 
analysis, $125,000 for publication of the results, $170,000 for project 
management and $415,000 for overhead costs.

             Exhibit 3--Estimated Total and Annualized Cost
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                                                            Annualized
             Cost component                 Total cost         cost
------------------------------------------------------------------------
Project Development.....................        $785,000        $262,000
Data Collection Activities..............          70,000          35,000
Data Processing and Analysis............         235,000          78,000
Publication of Results..................         125,000         125,000
Project Management......................         170,000          57,000
Overhead................................         415,000         138,000
                                         -------------------------------

[[Page 32786]]

 
    Total...............................       1,800,000         900,000
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Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, 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 healthcare research and healthcare 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.

    Dated: May 28, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-13728 Filed 6-8-10; 8:45 am]
BILLING CODE 4160-90-M


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