Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices 35485 

http://www.hhs.gov/healthit/ahic/ 

population/pop_instruct.html. 

Dated: June 20, 2007. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 07–3170 Filed 6–27–07; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Quality Workgroup 

Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

10th meeting of the American Health 

Information Community Quality 

Workgroup in accordance with the 

Federal Advisory Committee Act (Pub. 

L. 92–463, 5 U.S.C., App.). 

DATES: July 18, 2007, from 1 p.m. to 4 

p.m. [Eastern]. 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 4090 (please 

bring photo ID for entry to a Federal 

building). 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

quality/. 

SUPPLEMENTARY INFORMATION: The 

Workgroup will continue its discussion 

on how health information technology 

can provide the data needed for the 

development of quality measures that 

are useful to patients and others in the 

health care industry, automate the 

measurement and reporting of a 

comprehensive current and future set of 

quality measures, and accelerate the use 

of clinical decision support that can 

improve performance on those quality 

measures. 

The meeting will be available via Web 

cast. For additional information, go to: 

http://www.hhs.gov/healthit/ahic/ 

quality/quality_instruct.html. 

Dated: June 20, 2007. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 07–3171 Filed 6–27–07; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Consumer Empowerment 

Workgroup Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

18th meeting of the American Health 

Information Community Consumer 

Empowerment Workgroup in 

accordance with the Federal Advisory 

Committee Act (Pub. L. 92–463, 5 

U.S.C., App.). 

DATES: July 11, 2007, from 1 p.m. to 4 

p.m. [Eastern]. 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 4090. Please 

bring photo ID for entry to a Federal 

building. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

consumer/. 

SUPPLEMENTARY INFORMATION: The 

Workgroup will continue its discussion 

on how to encourage the widespread 

adoption of a personal health record 

that is easy-to-use, portable, 

longitudinal, affordable, and consumercentered. 

The meeting will be available via Web 

cast. For additional information, go to: 

http://www.hhs.gov/healthit/ahic/ 

consumer/ce_instruct.html. 

Dated: June 20, 2007. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 07–3172 Filed 6–27–07; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the National Coordinator for 

Health Information Technology; 

American Health Information 

Community Electronic Health Records 

Workgroup Meeting 

ACTION: Announcement of meeting. 

SUMMARY: This notice announces the 

17th meeting of the American Health 

Information Community Electronic 

Health Records Workgroup in 

accordance with the Federal Advisory 

Committee Act (Pub. L. 92–463, 5 

U.S.C., App.). 

DATES: July 10, 2007, from 1 p.m. to 4 

p.m. [Eastern]. 

ADDRESSES: Mary C. Switzer Building 

(330 C Street, SW., Washington, DC 

20201), Conference Room 4090. Please 

bring photo ID for entry to a Federal 

building. 

FOR FURTHER INFORMATION CONTACT: 

http://www.hhs.gov/healthit/ahic/ 

healthrecords/. 

SUPPLEMENTARY INFORMATION: The 

Workgroup will continue its discussion 

on ways to achieve widespread 

adoption of certified EHRs, minimizing 

gaps in adoption among providers. 

The meeting will be available via Web 

cast. For additional information, go to: 

http://www.hhs.gov/healthit/ahic/ 

heatlhrecords/ehr_instruct.html. 

Dated: June 20, 2007. 

Judith Sparrow, 

Director, American Health Information 

Community, Office of Programs and 

Coordination, Office of the National 

Coordinator for Health Information 

Technology. 

[FR Doc. 07–3173 Filed 6–27–07; 8:45 am] 

BILLING CODE 4150–24–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Health Care 

Research and Quality, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

and 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. 

An earlier version of this proposed 

information collection notice was 

previously published in the Federal 

Register and a period of 90 days was 

allowed for public comment. At the 

request of OMB, AHRQ is publishing 

this notice to allow an additional 30 

days for public comment. The original 

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35486 Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices 

30 day notice is available at http:// 

a257.g.akamaitech.net/7/257/2422/ 

01jan20071800/edocket.access.gpo.gov/ 

2007/pdf/07-574.pdf . 

DATES: Comments on this notice must be 

received by July 30, 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)’’

AHRQ will develop and pilot test an 

electronic system for reporting 

medication errors and adverse drug 

events that occur in outpatient 

physician practices. The reporting 

system, MEADERS, is being developed 

in collaboration with the Food and Drug 

Administration (FDA) and data 

collected will closely mirror 

information included in paper-based 

physician reports to MedWatch. While 

the major purpose of this project is to 

determine the ability and willingness of 

busy clinicians to use the electronic 

reporting system and to investigate 

barriers and facilitators to its actual use 

in practice, the data collected on 

medication errors and adverse drug 

events will be reported back to practices 

for their use in improving the quality of 

care provided. The landmark Harvard 

Medical Practice Study, published in 

1991, stated that 98,000 Americans die 

each year from medical errors. (Ref: 

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.) 

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. (Ref: McDonald CJ, 

Weiner J, Hui SL. Deaths due to medical 

errors are exaggerated in the Institute of 

Medicine Report. JAMA. 2000; 284:93–

95 and Leape LL. Institute of Medicine 

medical error figures are not 

exaggerated. JAMA. 2000; 28:95–97). 

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. (Ref: 

Hayward RA, Hofer TP. Estimating 

hospital deaths due to medical errors: 

Preventability is in the eye of the 

reviewer. JAMA. 2001; 286:415–420). 

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, (Ref: Institute of Medicine. To Err 

Is Human: Building a Safer Health 

System. Washington, DC: National 

Academy Press, 2000), their effects on 

the quality of care, (Ref: Institute of 

Medicine. Crossing the Quality Chasm: 

A New System for the 21st Century. 

Washington, DC: National Academy 

Press, 2001), and offering suggestions on 

improving patient safety. (Ref: Institute 

of Medicine. Patient Safety: Achieving a 

New Standard for Care. Washington, 

DC: National Academy Press, 2004). 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 decisons (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. (Ref: http:// 

www.blsmeetings.net/ 

PatientSafetyandHIT/ (Accessed August 

11, 2005)). 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. (Ref: Green LA, Fryer GE, 

Yawn BP, Lanier D, Dovey SM: The 

ecology of medical care revisited. N 

Engl J Med 2001; 344:2021–2025). 

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. In most 

primary care practices there is no 

mechanism in place to report 

medication errors as they occur, and 

adverse drug events observed in the 

primary care setting are currently underreported to the FDA. (Ref: 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). We propose to 

develop and pilot test a computer-based 

error reporting system to better 

understand the ability of physicians to 

identify their own medication errors as 

well as adverse drug events, and their 

willingness to report them 

electronically. The fundamental 

objectives are to (1) evaluate the 

usefulness, ease of use, and actual use 

of the system in everyday clinical 

practices, and (2) identify provider and 

practice characteristics that predict 

uptake and use of this system in 

participating primary care practices. 

The data collected on medication errors 

and adverse drug events will be 

aggregated by practice and fed back to 

the practice for its use in improving the 

quailty of care provided. 

Methods of Collection 

A total of 45 physicians and their 

practice staff will participate in the pilot 

test of the reporting system in addition 

to completing baseline surveys of their 

practice and reporting on use and 

satisfaction with the reporting system. 

The reporting system will request 

information about the patient involved 

(to be encrypted), category of event 

(error, adverse drug event, drug-drug 

interaction), timing of event, specific 

medications involved, type of event 

(e.g., wrong drug prescribed, wrong 

dose, wrong patient), contributing 

factors, and evidence of patient harm. 

The surveys will 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 

MEADERS system. Data collected on the 

system’s use will include the number of 

clinicians who have used MEADERS at 

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Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices 35487 

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. A 

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 study 

period has concluded. 

Although any clinician in the practice 

will be able to use the system, 

physicians are likely to be the primary 

users of the system. We estimate 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. 

Estimated Annual Respondent Burden 

EXHIBIT 1.—ESTIMATE OF COST BURDEN TO RESPONDENTS

Data collection effort 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 ...................................... 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 57.90 651.38 

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 error ..................... 18 0 .134 2 .4 12.58 30.19 

Office 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: Occupation 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 

$640,000.00. 

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. 

Dated: June 21, 2007. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 07–3159 Filed 6–27–07; 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: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

the Office of Management and Budget 

(OMB) to allow the proposed 

information collection project: 2008–

2009 Medical Expenditure Panel 

Survey—Insurance Component (MEPS–

IC). In accordance with the Paperwork 

Reduction Act of 1995, Pub. L. 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 August 27, 2007. 

ADDRESSES: Written comments should 

be submitted to: William Carroll, 

Reports Clearance Officer, AHRQ, 540 

Gaither Road, Room 5048, Rockville, 

MD 20850. 

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: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

2008 and 2009 Medical Expenditure 

Panel Survey—Insurance Component 

(MEPS–IC). 

The MEPS–IC, an annual survey of 

the characteristics of employersponsored health insurance, was first 

conducted by AHRQ in 1997 for the 

calendar year 1996. The survey has 

since been conducted annually for 

calendar years 1997 through 2006. 

AHRQ proposes to continue this annual 

survey of establishments for calendar 

years 2008 and 2009. The survey data 

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