[Federal Register Volume 59, Number 57 (Thursday, March 24, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6907]


[[Page Unknown]]

[Federal Register: March 24, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
RIN 0905-ZA03
[CDC-416]

 

Announcement of a Cooperative Agreement to the Ambulatory 
Sentinel Practice Network

Summary

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1994 funds for a sole source 
cooperative agreement with the Ambulatory Sentinel Practice Network 
(ASPN) for the Laboratory Medicine Quality Improvement Program. 
Approximately $200,000 is available in FY 1994 to fund this cooperative 
agreement. It is expected that the award will begin on May 1, 1994, and 
will be made for a 12-month budget period within a project period of up 
to 5 years. Funding estimates may vary and are subject to change. 
Continuation awards within the project period will be made on the basis 
of satisfactory progress and the availability of funds.
    The purpose of this cooperative agreement is to increase the 
ability of the primary care physician to determine: (1) Problems that 
exist in the total process of laboratory testing, (2) how often 
problems occur, (3) what impact these problems have on patient care, 
and (4) what interventions can be developed to improve the total 
testing process. Activities to achieve these ends will include two 
primary focus areas. The first area of focus is studying the extent and 
nature of problems in the diagnosis and treatment of patients caused by 
inaccurate laboratory test results. The second area of focus is 
studying the effect of errors on patient care in each component of the 
clinical laboratory testing process to include the following: (a) 
Communication between the attending physician and the clinical 
laboratory which is to conduct the tests; (b) selection of the tests to 
be performed; (c) limits applicable to the tests selected; (d) 
acquisition of the specimen to be tested; (e) transportation of the 
specimen to the laboratory, (f) storage of the specimen by the 
laboratory, (g) analysis of the specimen by the laboratory; and, (h) 
reporting of the results by the laboratory.
    These studies will be addressed by individual primary care 
physicians and others in the practices affiliated with ASPN using 
investigative strategies established in cooperation with CDC. Specific 
activities include the development of protocols and survey forms, data 
analysis and creation of interventions to improve the total testing 
process in primary care physicians' practices.
    CDC will: (1) Collaborate in questionnaire development for 
profiling ASPN clinicians and practices, problem identification, and 
results analysis; (2) collaborate in the development and implementation 
of surveillance for specific types of laboratory problems occurring in 
the pre- and post-analytic phases of the testing process. This includes 
collaborating on card questionnaire development, data analysis, and 
writing summaries of the results; (3) collaborate in the development 
and implementation of focused surveillance for problems occurring in 
the analytic phase of the testing process. CDC will assist with card 
questionnaire development, data analysis, and writing summaries of the 
results; (4) collaborate in the development and implementation of a 
patient-oriented sentinel method. CDC will assist with questionnaire 
development, results analysis, and writing summaries of the results; 
(5) collaborate in the development of recommendations for improving the 
total testing process in ASPN practices. CDC will also collaborate in 
developing the methods for testing these recommendations and measuring 
changes in quality of the testing process. This will include developing 
specific recommendations for quality improvement interventions, 
assisting with developing measurement tools, analyzing results, and 
writing summaries of the results; (6) assist ASPN staff with 
presentations (including visuals, materials, etc.) of the progress 
towards achieving objectives at each of the annual ASPN convocations. 
CDC staff will also assist in the presentations at the annual ASPN 
convocations; and (7) assist ASPN staff in the preparation of 
manuscripts related to the activities in this project.
    The Public Health Service (PHS) is committed to achieving the 
health promotion and disease prevention objectives of ``Healthy People 
2000,'' a PHS-led national activity to reduce morbidity and mortality 
and improve the quality of life. This announcement is related to 
priority area 22 improving surveillance and data systems by the Year 
2000. (For ordering a copy of ``Healthy People 2000,'' see the section 
WHERE TO OBTAIN ADDITIONAL INFORMATION.)

Authority

    This program is authorized under section 317(k)(3) of the Public 
Health Service Act, 42 U.S.C. 247b(k)(3), as amended.

Eligible Applicant

    Assistance will be provided only to the Ambulatory Sentinel 
Practice Network (ASPN). No other applications are solicited. The 
program announcement and application kit have been sent to ASPN.
    ASPN is a non-profit organization of primary health care 
practitioners in the United States and Canada. ASPN's goal is to 
increase and refine the primary care knowledge base by studying the 
problems that occur in the primary care setting.
    ASPN is the most appropriate organization to conduct the work under 
this cooperative agreement because:
    1. It is more cost effective to utilize the services of ASPN since 
the clinicians and the laboratories in this program are already members 
of an organized network. To obtain a listing of clinicians and 
establish a new network would require additional time (years) and 
funds.
    2. ASPN has established methods for routinely collecting and 
reporting data from its membership. The systems, staff, and other 
resources are in place, available to be used for this proposed project. 
Patient records are accessible to ASPN for follow-up and investigative 
purposes.
    3. ASPN clinicians have participated in a replication of the 
National Center for Health Statistics (NCHS) National Ambulatory 
Medical Care Survey which allows for comparisons of ASPN practices with 
a national sample.
    4. The majority of in-office laboratory testing takes place in a 
primary care setting. ASPN is the only national, primary care, 
practice-based research network operating in the United States at the 
present time.
    5. Although other smaller primary care, practice-based research 
networks have been established in the United States, ASPN has the most 
diverse geographic distribution which enhances the generalizability of 
the data collected in this study.
    6. The composition of the ASPN network members includes a 
significant number of rural practices, a feature not present in other 
practice-based research networks operating in the United States at the 
present time.
    7. The ASPN network services approximately 350,000 active patients. 
As laboratory errors are considered to be statistically rare events, 
the large number of patients seen in the network greatly augments the 
power of the studies.
    8. ASPN has an established reporting rate of 93-98 percent. This is 
markedly higher than what one would expect to be able to achieve 
outside of a practice-based research network. The high reporting rate 
is due to monitoring and follow-up protocols used by the research 
support staff with ASPN. The high reporting rate makes the data 
collection more efficient and complete.
    9. The ASPN network contains a small number of practices in Canada. 
This small subset of the network can be used as an internal control to 
assess changes in the practice of laboratory medicine in the United 
States compared to Canada.
    10. All ASPN network physicians are required to endorse and support 
the participation of their practices by recording and reporting 
accurate data about patients collaboratively with other ASPN practices. 
Accurate and current data are paramount in this project.
    11. There is no other known provider which can provide this type of 
investigative project.

Executive Order 12372 Review

    This program is not subject to the Executive Order 12372 review.

Public Health System Reporting Requirements

    This program is not subject to the Public Health System Reporting 
Requirements.

Catalog of Federal Domestic Assistance Number (CFDA)

    The Catalog of Federal Domestic Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

    Projects that involve the collection of information from 10 or more 
individuals and funded by the cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.

Where To Obtain Additional Information

    If you are interested in obtaining additional information regarding 
this project, please refer to Announcement Number 416 and contact 
Carole J. Tully, Grants Management Specialist, Grants Management 
Branch, Centers for Disease Control and Prevention (CDC), 255 East 
Paces Ferry Road, NE., room 300, Mailstop E-09, Atlanta, Georgia 30305, 
telephone (404) 842-6880.
    A copy of ``Healthy People 2000'' (Full Report, Stock No. 017-001-
00474-0) or ``Healthy People 2000'' (Summary Report, Stock No. 017-001-
00473-1) referenced in the SUMMARY may be obtained through the 
Superintendent of Documents, Government Printing Office, Washington, DC 
20402-9325, telephone (202) 783-3238.

    Dated: March 17, 1994.
Robert L. Foster,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC)
[FR Doc. 94-6907 Filed 3-23-94; 8:45 am]
BILLING CODE 4163-18-P