[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 [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: Dons Lefkowitz, AHRQ Reports Clearance
Officer, (301) 427-1477, or by e-mail at [email protected].
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:
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.
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.
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.
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.
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]]
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
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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
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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
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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
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Total....................................... 226 2,458 na 77,387
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\*\ 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
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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
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[[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