[Federal Register: February 13, 2007 (Volume 72, Number 29)]
[Notices]
[Page 6731-6733]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe07-51]
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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, Department of
Health and Human Services.
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) 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.
This proposed information collection was previously published in
the Federal Register on December 12th, 2006 and allowed 60 days for
public comment. No public 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 March 15, 2007.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036,
Rockville, MD 20850, or by e-mail at doris.lefkowitz@ahrq.hhs.gov.
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\
[[Page 6732]]
In response to the growing concern over medical errors, the Agency
for Healthcare Research and Quality (AHRQ) has published three
important monographs outlining the problems 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
``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 USC 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 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 chose 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
lease 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
[[Page 6733]]
Exhibit 1.--Estimate of Cost Burden to Respondents
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Estimated
Estimated Estimated Average annual cost
Date collection effort Number of time per total burden hourly wage burden to
responses* respondent hours rate** ($) respondents
in hours ($)
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Office Manager baseline survey.......... 45 0.25 11.25 $34.67 $390.04
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Physician baseline survey............... 45 0.25 11.25 57.90 651.38
Physician opinion survey of system...... 45 0.25 11.25 57.90 651.38
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 18 0.134 2.4 12.58 30.19
error..................................
Office Manager opinion-survey of system. 45 0.25 11.25 34.67 390.04
-------------- -------------- ---------------
Total............................... 585 ............ 114.89 ............ 4769.93
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*Based on a six month trial period of MEADER reporting.
**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.
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\ http://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 GP.
Perceived barriers to medical-error reporting: an exploratory
investigation. J Healthcare Management. 2002; 47(4):263-79.
Dated: January 30, 2007.
Carolyn M. Clancy,
Director.
[FR Doc. 07-574 Filed 2-12-07; 8:45 am]
BILLING CODE 4160-90-M