Agency Information Collection Activities: Proposed Collection; Comment Request, 74537-74539 [06-9643]
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Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices
Estimated Annual Costs to the Federal
Government
The total cost to the Government for
developing this survey is approximately
$319,000, and is being funded solely by
AHRQ. This estimate includes the costs
of a background literature review,
survey development, cognitive testing,
pilot data collection, data analysis, and
preparation of final deliverables and
reports.
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 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.
Dated: December 1, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–9642 Filed 12–11–06; 8:45 am]
BILLING CODE 4160-90-M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, Department of Health and
Human Services.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
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) allow the proposed
VerDate Aug<31>2005
18:00 Dec 11, 2006
Jkt 211001
information collection project:
‘‘Development of an Electronic System
for Reporting Medication Errors and
Adverse Drug Events in Primary Care
Practice (MEADERS).’’ In accordance
with the Paperwork Reduction Act of
1995, Public Law 104–13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public
to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by February 12, 2007.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Room #5036, Rockville,
MD 20850.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from AHRQ’s Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427–1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘Development of an Electronic System
for Reporting Medication Errors and
Adverse Drug Events in Primary Care
Practice (MEADERS)’’
The project is being conducted in
response to an AHRQ RFP entitled
‘‘Resource Center for Primary Care
Practice-Based Research Networks
(PBRNs)’’ (issued under Contract 290–
88–0008).
In response to a proposed
modification to AHRQ contract no.
290.02.0008, the PBRN Resource Center
is proposing to assist AHRQ in its
continued commitment to assessing the
status and capabilities of its funded
PBRNs and making available to them
the tools and resources necessary to
improve the quality of care they
provide. Through the modification of
this contract, the PBRN Resource Center
will develop and make available an
electronic system for reporting
medication errors and adverse drug
events that occur in outpatient
physician practices of selected PBRNs to
their own practices for quality
improvement purposes and to the Food
and Drug Administration (FDA).
The landmark Harvard Medical
Practice Study was published in 1991
and stated that 98,000 Americans die
each year from medical errors. 1
Although the exact figure has been
disputed, no one disputes the fact that
too many Americans are injured
unnecessarily by medical mistakes that
could be avoided.2 3 Another study
performed by the Department of
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Fmt 4703
Sfmt 4703
74537
Veterans Affairs suggests that in one out
of every 10,000 hospitalizations, a
patient dies due directly to a medical
error .4
In response to the growing concern
over medical errors, the Agency for
Healthcare Research and Quality
(AHRQ) has published three important
monographs outlining the problem of
errors,5 their effects on the quality of
care,6 and offering suggestions on
improving patient safety.7 The first
recommendation of this third
monograph was to ‘‘capture information
on patient safety—including both
adverse events and near misses—as a
byproduct of care, and use this
information to design even safer care
delivery systems.’’ One central theme to
each of these monographs is that there
simply is too much chaotic information
flowing in the medical environment for
a single provider to handle effectively.
Therefore, solutions to the problem of
medical errors should include some
combination of health information
technology and redesign of health care
systems to enhance the prevalence of
appropriate decisions (i.e., avoiding
errors of omission) and reduce the
occurrence of avoidable mistakes (i.e.,
avoiding errors of commission).
A recent conference sponsored by
AHRQ highlighted interventions to
improve medical decision-making and
reduce medical errors.8 Most of the
interventions presented were based in
hospitals, where the most intensive and
immediately life-threatening events
occur. Yet the majority of medical
decisions are made in outpatient
practices and offices where there has
been little error-reduction research
performed. Further, most outpatient
studies have been performed in
academic medical centers which have
capabilities, providers, and patients that
may not typify the average U.S. medical
practice.9
With the recent passing of the Patient
Safety and Quality Improvement Act of
2005, 42 U.S.C. 299b–21–b–26, now is
an opportune time to evaluate a primary
care error reporting system, and PBRNs
are an ideally suited place to study
interventions aimed at reporting and
reducing medical errors. In most
primary care practices there is no
mechanism in place to report medical
errors as they occur. We propose to
develop, implement, and study an
outpatient error reporting system to
better understand the ability of
physicians to identify their own errors
and their willingness to report them to
their own practices and the FDA and
AHRQ. We will focus on the most
common invasive intervention invoked
in outpatient practice—drug treatment
E:\FR\FM\12DEN1.SGM
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74538
Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices
of acute and chronic conditions—and
will create and test a paper- and
computer-based system for both
capturing medication errors and
reporting adverse drug events, which
are also under-reported.10
The fundamental objective is to
utilize the Resource Center’s expertise
in health information technology and its
working relationships with PBRNs to
support AHRQ’s objectives in
developing and evaluating systems for
reporting medication errors and adverse
drug events in primary care. We will
accomplish this objective through (1)
Developing and implementing an
electronic and paper-based outpatient
medication error and adverse event
reporting system, (2) evaluating the
usefulness, ease of use, and actual use
of the system in everyday clinical
practices, and (3) identifying patient,
provider, and practice characteristics
that predict uptake and use of this
system in participating primary care
practices.
Methods of Collection
The value of MEADERS to practicing
primary care clinicians will be
illustrated by performing demonstration
implementations in two PBRNs. A
PBRN is a group of clinicians working
together, either locally or nationally, to
conduct research and implement
research findings into practice settings.
A total of 45 physicians and their
practice staff will participate in the field
test in addition to completing baseline
surveys of their practice.
A request for proposals will be sent to
all PBRNs that have registered with the
PBRN Resource Center. A review
committee consisting of a selection of
four expert panel members, one or two
PBRN representatives, and some
members of the PBRN Resource Center
will evaluate the applications. The
AHRQ Project Officer will chair the
review committee and, together with
PBRN Resource Center staff, develop a
set of review criteria. The review
committee will make recommendations
to the PBRN Resource Center who will
make the final determination of
participating PBRNs. Once the PBRNs
are selected, each PBRN will choose up
to three of its affiliated practices to
participate in this trial. Although initial
participation by a practice is voluntary,
once selected the practice must provide
assurances that at least three to five
clinicians will agree to use the system
and that the practice will support the
project.
The PBRN Resource Center will
develop a series of surveys to capture
data describing the practice and the
patients it serves, the extent of the error
reporting system’s use, and an
assessment of the users’ overall
satisfaction with the system. practice
and provider information will be
collected at baseline along with
characteristics that could be facilitators
(such as an electronic medical record
system) or barriers (such as lack of time
and resources needed to report
information) to implementation of the
MEADER system. Data collected on the
system’s use will include the number of
clinicians who have used MEADERS at
least once, the number of times used
overall, the time it takes to enter data
into the electronic MEADERS, and the
types of medication errors and adverse
drug events that are being reported.
Both the paper and electronic versions
of the system will be assessed at the
conclusion of the evaluation period. The
follow-up assessment will include
clinicians’ and managers’ satisfaction
with the system (e.g., ease of use,
usefulness of the generated reports and
individual feedback) and whether they
intend to continue its use after the
initial study period has concluded.
Finally, semi-structured interviews and
conference call discussions will be used
to collect additional comments and
suggestions for future implementation of
MEADERS.
Although any clinician in the practice
will be able to use the system,
physicians are likely to be the primary
users of the system. The Resource
Center is estimating that physicians will
account for about 80% of MEADERS use
and Nurse Practitioners, Physician
Assistants and Medical Assistants will
make up the remainder (See Exhibit 1).
The time for entering an event into the
system is estimated to require no more
than 8 minutes of a clinician’s time.
Wherever possible, existing validated
measures will be used. Where validated
measures do not exist, new measures
will be developed and assessed. The
final instruments will be field tested
within selected practices in the PBRNs
chosen to participate in the
implementation study.
Estimated Annual Respondent Burden
EXHIBIT 1.—ESTIMATE OF COST BURDEN TO RESPONDENTS
Number of
responses*
Estimated
time per
respondent
in hours
Estimated
total burden
hours
Average
hourly wage
rate**
Estimated
annual cost
burden to
respondents
Office Manager baseline survey ................................................................
Physician baseline survey .........................................................................
Physician opinion survey of system ..........................................................
Physician entry of medication error ...........................................................
Nurse opinion survey of system ................................................................
Nurse entry of medication error .................................................................
PA/NP opinion survey of system ...............................................................
PA/NP entry of medication error ................................................................
Medical assistant survey of system ...........................................................
Medical assistant entry of medication error ...............................................
Officer Manager opinion-survey of system ................................................
45
45
45
216
45
18
45
18
45
18
45
0.25
0.25
0.25
0.134
0.25
0.134
0.25
0.134
0.25
0.134
0.25
11.25
11.25
11.25
28.94
11.25
2.4
11.25
2.4
11.25
2.4
11.25
$34.67
57.90
57.90
57.90
27.35
27.35
34.17
34.17
12.58
12.58
34.67
$390.04
651.38
651.83
1675.63
307.69
65.64
384.41
82.00
141.53
30.19
390.04
Total ....................................................................................................
585
....................
114.89
....................
4769.93
jlentini on PROD1PC65 with NOTICES
Data collection effort
*Based on a six month trial period of MEADER reporting system.
**Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States 2004, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
This information collection will not
impose a cost burden on the respondent
beyond that associated with their time
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to provide the required data. There will
be no additional costs for capital
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equipment, software, computer services,
etc.
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Federal Register / Vol. 71, No. 238 / Tuesday, December 12, 2006 / Notices
investigation. J Healthcare Management.
2002;47(4):263–79.
Estimated Costs to the Federal
Government
The total cost to the government for
this activity is estimated to be
$1,000,000.00.
jlentini on PROD1PC65 with NOTICES
Request for Comments
In accordance with the above-cited
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 health care research and
information dissemination functions of
AHRQ, 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 request for OMB
approval of the proposed information
collection. All comments will become a
matter of public record.
References
1 Brennan TA, Leape LL, Laird NM, et al.
Incidence of adverse events and negligence
in hospitalized patients: Results of the
Harvard Medical Practice Study. N Engl J
Med 1991; 324:370–376.
2 McDonald CJ, Weiner M, Hui SL. Deaths
due to medical errors are exaggerated in the
Institute of Medicine Report. JAMA 2000;
284:93–95.
3 Leape LL. Institute of Medicine medical
error figures are not exaggerated. JAMA.
2000; 28:95–97.
4 Hayward RA, Hofer TP. Estimating
hospital deaths due to medical errors:
preventability is in the eye of the reviewer.
JAMA. 2001; 286:415–420.
5 Institute of Medicine. To Err is Human:
Building a Safer Health System. Washington,
DC: National Academy Press, 2000.
6 Institute of Medicine. Crossing the
Quality Chasm: A New System for the 21st
Century. Washington, DC: National Academy
Press, 2001.
7 Institute of Medicine. Patient Safety:
Achieving a New Standard for Care.
Washington, DC: National Academy Press,
2004.
8 https://www.blsmeetings.net/
PatientSafetyandHIT/ (Accessed August 11,
2005).
9 Green LA, Fryer GE, Yawn BP, Lanier D,
Dovey SM: The ecology of medical care
revisited. N Engl J Med 2001; 344:2021–2025.
10 Uribe CL, Schweikhart SB, Pathak DS,
Dow M, Marsh GB. Perceived barriers to
medical-error reporting: an exploratory
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18:00 Dec 11, 2006
Jkt 211001
Dated: December 1, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–9643 Filed 12–11–06; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–07–0008]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call the CDC Reports Clearance
Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Emergency Epidemic Investigations
(0920–0008)—Revision—Office of
Workforce and Career Development
(OWCD), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
One of the objectives of CDC’s
epidemic services is to provide for the
prevention and control of epidemics
and protect the population from public
health crises such as man made or
natural biological disasters and
chemical emergencies. This objective is
carried out, in part, by training
investigators, maintaining laboratory
capabilities for identifying potential
problems, collecting and analyzing data,
and recommending appropriate actions
to protect the public’s health. When
state, local, or foreign health authorities
request help in controlling an epidemic
or solving other health problems, CDC
dispatches skilled epidemiologists from
the Epidemiologist Intelligence Service
(EIS) to investigate and resolve the
problem.
The purpose of the Emergency
Epidemic Investigation surveillance is
to collect data on the conditions
surrounding and preceding the onset of
a problem. The data must be collected
in a timely fashion so that information
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74539
can be used to develop prevention and
control techniques, to interrupt disease
transmission and to help identify the
cause of an outbreak. Since the events
necessitating the collections of
information are of an emergency nature,
most data collection is done by direct
interview or written questionnaire and
are one-time efforts related to a specific
outbreak or circumstance. If during the
emergency investigation, the need for
further study is recognized, a project is
designed and separate OMB clearance is
required. Interviews are conducted to be
as unobtrusive as possible and only the
minimal information necessary is
collected. The Emergency Epidemic
Investigations is the principal source of
data on outbreaks of infectious and
noninfectious diseases, injuries,
nutrition, environmental health and
occupational problems.
Each investigation does contribute to
the general knowledge about a
particular type of problem or
emergency, so that data collections are
designed to take into account similar
situations in the past. Some
questionnaires are standardized, such as
investigations of outbreaks aboard
aircraft or cruise vessels.
The Emergency Epidemic
Investigations provides a range of data
on the characteristics of outbreaks and
those affected by them. Data collected
include demographic characteristics,
exposure to the causative agent(s),
transmission patterns and severity of the
outbreak on the affected population.
These data, together with trend data,
may be used to monitor the effects of
change in the health care system,
planning of health services, improving
the availability of medical services and
assessing the health status of the
population.
Users of the Emergency Epidemic
Investigations data include, but are not
limited to EIS Officers in investigating
the patterns of disease or injury,
investigating the level of risky
behaviors, identifying the causative
agent and identifying the transmission
of the condition and the impact of
interventions.
Epi Trip Reports are delivered to the
state health agency official requesting
assistance shortly after completion of
the Emergency Epidemic Investigation.
The official can comment on both the
timeliness and the practical utility of
the recommendations from the
investigation. CDC is requesting that a
new form be added to the current
clearance. Upon completion of the
Emergency Epidemic Investigation,
requesting officials at the state or local
health department will be asked to
complete a brief questionnaire to assess
E:\FR\FM\12DEN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Notices]
[Pages 74537-74539]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9643]
-----------------------------------------------------------------------
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, Department of
Health and Human Services.
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) allow the proposed information collection
project: ``Development of an Electronic System for Reporting Medication
Errors and Adverse Drug Events in Primary Care Practice (MEADERS).'' In
accordance with the Paperwork Reduction Act of 1995, Public Law 104-13
(44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this
proposed information collection.
DATES: Comments on this notice must be received by February 12, 2007.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036,
Rockville, MD 20850.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from AHRQ's Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427-1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
``Development of an Electronic System for Reporting Medication Errors
and Adverse Drug Events in Primary Care Practice (MEADERS)''
The project is being conducted in response to an AHRQ RFP entitled
``Resource Center for Primary Care Practice-Based Research Networks
(PBRNs)'' (issued under Contract 290-88-0008).
In response to a proposed modification to AHRQ contract no.
290.02.0008, the PBRN Resource Center is proposing to assist AHRQ in
its continued commitment to assessing the status and capabilities of
its funded PBRNs and making available to them the tools and resources
necessary to improve the quality of care they provide. Through the
modification of this contract, the PBRN Resource Center will develop
and make available an electronic system for reporting medication errors
and adverse drug events that occur in outpatient physician practices of
selected PBRNs to their own practices for quality improvement purposes
and to the Food and Drug Administration (FDA).
The landmark Harvard Medical Practice Study was published in 1991
and stated that 98,000 Americans die each year from medical errors. \1\
Although the exact figure has been disputed, no one disputes the fact
that too many Americans are injured unnecessarily by medical mistakes
that could be avoided.2 3 Another study performed by the
Department of Veterans Affairs suggests that in one out of every 10,000
hospitalizations, a patient dies due directly to a medical error .\4\
In response to the growing concern over medical errors, the Agency
for Healthcare Research and Quality (AHRQ) has published three
important monographs outlining the problem of errors,\5\ their effects
on the quality of care,\6\ and offering suggestions on improving
patient safety.\7\ The first recommendation of this third monograph was
to ``capture information on patient safety--including both adverse
events and near misses--as a byproduct of care, and use this
information to design even safer care delivery systems.'' One central
theme to each of these monographs is that there simply is too much
chaotic information flowing in the medical environment for a single
provider to handle effectively. Therefore, solutions to the problem of
medical errors should include some combination of health information
technology and redesign of health care systems to enhance the
prevalence of appropriate decisions (i.e., avoiding errors of omission)
and reduce the occurrence of avoidable mistakes (i.e., avoiding errors
of commission).
A recent conference sponsored by AHRQ highlighted interventions to
improve medical decision-making and reduce medical errors.\8\ Most of
the interventions presented were based in hospitals, where the most
intensive and immediately life-threatening events occur. Yet the
majority of medical decisions are made in outpatient practices and
offices where there has been little error-reduction research performed.
Further, most outpatient studies have been performed in academic
medical centers which have capabilities, providers, and patients that
may not typify the average U.S. medical practice.\9\
With the recent passing of the Patient Safety and Quality
Improvement Act of 2005, 42 U.S.C. 299b-21-b-26, now is an opportune
time to evaluate a primary care error reporting system, and PBRNs are
an ideally suited place to study interventions aimed at reporting and
reducing medical errors. In most primary care practices there is no
mechanism in place to report medical errors as they occur. We propose
to develop, implement, and study an outpatient error reporting system
to better understand the ability of physicians to identify their own
errors and their willingness to report them to their own practices and
the FDA and AHRQ. We will focus on the most common invasive
intervention invoked in outpatient practice--drug treatment
[[Page 74538]]
of acute and chronic conditions--and will create and test a paper- and
computer-based system for both capturing medication errors and
reporting adverse drug events, which are also under-reported.\10\
The fundamental objective is to utilize the Resource Center's
expertise in health information technology and its working
relationships with PBRNs to support AHRQ's objectives in developing and
evaluating systems for reporting medication errors and adverse drug
events in primary care. We will accomplish this objective through (1)
Developing and implementing an electronic and paper-based outpatient
medication error and adverse event reporting system, (2) evaluating the
usefulness, ease of use, and actual use of the system in everyday
clinical practices, and (3) identifying patient, provider, and practice
characteristics that predict uptake and use of this system in
participating primary care practices.
Methods of Collection
The value of MEADERS to practicing primary care clinicians will be
illustrated by performing demonstration implementations in two PBRNs. A
PBRN is a group of clinicians working together, either locally or
nationally, to conduct research and implement research findings into
practice settings. A total of 45 physicians and their practice staff
will participate in the field test in addition to completing baseline
surveys of their practice.
A request for proposals will be sent to all PBRNs that have
registered with the PBRN Resource Center. A review committee consisting
of a selection of four expert panel members, one or two PBRN
representatives, and some members of the PBRN Resource Center will
evaluate the applications. The AHRQ Project Officer will chair the
review committee and, together with PBRN Resource Center staff, develop
a set of review criteria. The review committee will make
recommendations to the PBRN Resource Center who will make the final
determination of participating PBRNs. Once the PBRNs are selected, each
PBRN will choose up to three of its affiliated practices to participate
in this trial. Although initial participation by a practice is
voluntary, once selected the practice must provide assurances that at
least three to five clinicians will agree to use the system and that
the practice will support the project.
The PBRN Resource Center will develop a series of surveys to
capture data describing the practice and the patients it serves, the
extent of the error reporting system's use, and an assessment of the
users' overall satisfaction with the system. practice and provider
information will be collected at baseline along with characteristics
that could be facilitators (such as an electronic medical record
system) or barriers (such as lack of time and resources needed to
report information) to implementation of the MEADER system. Data
collected on the system's use will include the number of clinicians who
have used MEADERS at least once, the number of times used overall, the
time it takes to enter data into the electronic MEADERS, and the types
of medication errors and adverse drug events that are being reported.
Both the paper and electronic versions of the system will be assessed
at the conclusion of the evaluation period. The follow-up assessment
will include clinicians' and managers' satisfaction with the system
(e.g., ease of use, usefulness of the generated reports and individual
feedback) and whether they intend to continue its use after the initial
study period has concluded. Finally, semi-structured interviews and
conference call discussions will be used to collect additional comments
and suggestions for future implementation of MEADERS.
Although any clinician in the practice will be able to use the
system, physicians are likely to be the primary users of the system.
The Resource Center is estimating that physicians will account for
about 80% of MEADERS use and Nurse Practitioners, Physician Assistants
and Medical Assistants will make up the remainder (See Exhibit 1). The
time for entering an event into the system is estimated to require no
more than 8 minutes of a clinician's time.
Wherever possible, existing validated measures will be used. Where
validated measures do not exist, new measures will be developed and
assessed. The final instruments will be field tested within selected
practices in the PBRNs chosen to participate in the implementation
study.
Estimated Annual Respondent Burden
Exhibit 1.--Estimate of Cost Burden to Respondents
----------------------------------------------------------------------------------------------------------------
Estimated Estimated Estimated
Number of time per total Average annual cost
Data collection effort responses* respondent burden hourly wage burden to
in hours hours rate** respondents
----------------------------------------------------------------------------------------------------------------
Office Manager baseline survey.................. 45 0.25 11.25 $34.67 $390.04
Physician baseline survey....................... 45 0.25 11.25 57.90 651.38
Physician opinion survey of system.............. 45 0.25 11.25 57.90 651.83
Physician entry of medication error............. 216 0.134 28.94 57.90 1675.63
Nurse opinion survey of system.................. 45 0.25 11.25 27.35 307.69
Nurse entry of medication error................. 18 0.134 2.4 27.35 65.64
PA/NP opinion survey of system.................. 45 0.25 11.25 34.17 384.41
PA/NP entry of medication error................. 18 0.134 2.4 34.17 82.00
Medical assistant survey of system.............. 45 0.25 11.25 12.58 141.53
Medical assistant entry of medication error..... 18 0.134 2.4 12.58 30.19
Officer Manager opinion-survey of system........ 45 0.25 11.25 34.67 390.04
---------------------------------------------------------------
Total....................................... 585 ........... 114.89 ........... 4769.93
----------------------------------------------------------------------------------------------------------------
*Based on a six month trial period of MEADER reporting system.
**Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States 2004, ``U.S. Department of Labor, Bureau of Labor Statistics.''
This information collection will not impose a cost burden on the
respondent beyond that associated with their time to provide the
required data. There will be no additional costs for capital equipment,
software, computer services, etc.
[[Page 74539]]
Estimated Costs to the Federal Government
The total cost to the government for this activity is estimated to
be $1,000,000.00.
Request for Comments
In accordance with the above-cited 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 health care research and
information dissemination functions of AHRQ, 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 request for OMB approval of the proposed
information collection. All comments will become a matter of public
record.
References
\1\ Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse
events and negligence in hospitalized patients: Results of the
Harvard Medical Practice Study. N Engl J Med 1991; 324:370-376.
\2\ McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors
are exaggerated in the Institute of Medicine Report. JAMA 2000;
284:93-95.
\3\ Leape LL. Institute of Medicine medical error figures are
not exaggerated. JAMA. 2000; 28:95-97.
\4\ Hayward RA, Hofer TP. Estimating hospital deaths due to
medical errors: preventability is in the eye of the reviewer. JAMA.
2001; 286:415-420.
\5\ Institute of Medicine. To Err is Human: Building a Safer
Health System. Washington, DC: National Academy Press, 2000.
\6\ Institute of Medicine. Crossing the Quality Chasm: A New
System for the 21st Century. Washington, DC: National Academy Press,
2001.
\7\ Institute of Medicine. Patient Safety: Achieving a New
Standard for Care. Washington, DC: National Academy Press, 2004.
\8\ https://www.blsmeetings.net/PatientSafetyandHIT/ (Accessed
August 11, 2005).
\9\ Green LA, Fryer GE, Yawn BP, Lanier D, Dovey SM: The ecology
of medical care revisited. N Engl J Med 2001; 344:2021-2025.
\10\ Uribe CL, Schweikhart SB, Pathak DS, Dow M, Marsh GB.
Perceived barriers to medical-error reporting: an exploratory
investigation. J Healthcare Management. 2002;47(4):263-79.
Dated: December 1, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06-9643 Filed 12-11-06; 8:45 am]
BILLING CODE 4160-90-M
