[Federal Register Volume 71, Number 238 (Tuesday, December 12, 2006)]
[Notices]
[Pages 74537-74539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9643]


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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.

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 <greek-i>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.<SUP>2 3</SUP> 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
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                                                               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
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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
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*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\ 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 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