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The laboratory's role in outcome assessment.

How does the laboratorian influence patient outcome, and how is this influence measured? The clinical laboratory gives vital support to decisions about diagnosis, treatment, and management. Outcome assessment must include a structured approach to performance improvement, proper test utilization, and defining best practices.

Outcome assessment has become a popular strategy in the healthcare industry to improve the effectiveness of patient care. Escalating healthcare costs, certain population health status indicators, and variations in medical practice have contributed significantly to this new emphasis. Government, private insurers, and accrediting agencies continue to compare technologies, assess healthcare performance, select providers, and define optimum practices using outcome assessment data.

Because the clinical laboratory supports physician decisions regarding the diagnosis, treatment, and monitoring of disease, lab professionals cannot ignore their important role in outcome assessment, management, and improvement. Laboratory involvement in this initiative began when pathologists and lab directors began actively participating in the development and implementation of practice guidelines. Other laboratorians have applied continuous quality improvement (CQI) tools to enhance the outcome of many intralaboratory processes that affect the quality and timeliness of lab data.

There are different types of outcome assessment, however. Unfortunately, while lab professionals work hard to improve departmental performance in areas such as turnaround time, result reporting, and specimen quality (i.e., laboratory outcome), the laboratory continues to run tests that contribute little to patient outcome. Pathologists, lab directors, and lab staff members, therefore, must coordinate their efforts to create a structured approach to performance improvement, proper test utilization, and defining best practices.


Patient outcome can be defined and assessed at different levels, from the U.S. population as a whole, to that of a community or region, to that of an organization, or by each individual patient. An outcome is the condition of patient at the end of therapy or a disease process, including the degree of wellness and the need for continued care, medication, support, and education. Donabedian defines outcome as the states or conditions of individuals and populations attributable to healthcare that includes changes in health status and knowledge or behavior pertinent to future health states, as well as satisfaction with health care.[1] In its Accreditation Manual for Hospitals, the Joint Commission on Accreditation of Healthcare Organizations defines outcome as the result of the performance (or non-performance) of a function or process.[2] More recently, JCAHO plans to add outcomes measures to its accreditation standards (see Newsmakers of the Year Honorable Mention: Standards for more than just equipment, Dec. 1997, MLO, p. 31).

Fundamentally, patient outcome is the result of medical care on a person's well-being in terms that are perceptible to that individual. Final patient outcome refers to a patient's health status - function of ultimate symptoms, changes in quality of life, and satisfaction with care after clinical decisions and practices have been delivered. Typically, clinical decisions and practices rely on and many times are based on laboratory data. A key question relevant to a patient's outcome assessment is this: "How has his/her health status changed since healthcare services have been rendered?" Various quality of life assessment tools have been developed to help address this very question, including these survey instruments:

1. JCAHO's IMSystem

2. National Committee for Quality Assurance's Health Plan Employer Data and Information Set (NCQA's NEDIS) 3.0

3. The University of Wisconsin's Minimal Data Set (MDS)

4. The University of Colorado's Outcomes and Assessment Information Set (OASIS), and

5. Medical Outcomes Trust Short Form-36 (SF-36).

The SF-36 questionnaire was developed to evaluate the impact of medical interventions on health status in nine domains[3]:

1. Physical functioning

2. Social functioning

3. Role limitations caused by physical problems

4. Role limitations caused by emotional problems

5. Mental health

6. Energy/vitality

7. Physical pain

8. Perception of general health

9. Changes in health over the past year

Each of these nine areas contains questions about a patient's health and the ability to function and is scored on a scale from 0-100, where 100 represents optimal health. Once a final score is calculated, it is compared with the scores of other patients who participated in the study.

The Medical Outcomes Trust (a consortium of managed care providers), which holds a copyright to SF-36, maintains a comprehensive listing of current studies on the Internet at Users can access this Web site to obtain information on current studies comparing the outcomes of treatment alternatives and patient satisfaction/preferences for rheumatoid arthritis, laser versus standard resection for transurethral prostatectomy, open versus laparoscopic hernia repair, plastic surgery, sleep apnea, menorrhagia treatment, and Parkinson's disease. As more such studies are completed, healthcare providers will become increasingly accountable for effective medical care and cost effectiveness, and laboratorians will play a greater role in developing and implementing guidelines to help reduce practice variation and ensure the appropriate use of lab services.

Practice guidelines

Government agencies, medical specialty societies, and private insurers support different approaches to the development of practice guidelines and refer to this initiative by different names, including clinical guidelines, clinical practice guidelines, practice policies, practice parameters, clinical pathways, and medical necessity guidelines.

One approach to guideline development follows[4]:

1. Identify an important health outcome.

2. Analyze evidence for the effects of practice on this outcome.

3. Estimate benefits and potential harm to patient resulting from the outcome.

4. Compare benefits and harm data.

5. Estimate costs.

6. Compare health outcome with these costs.

7. Compare alternative practices to determine priority.

An example of one such effort is a 1988 study published by the National Heart, Lung, and Blood Institute entitled, "Detection, evaluation, and treatment of high blood cholesterol in adults." This report was followed in 1990 by the Laboratory Standardization Panel Report, which recommends improving the accuracy of cholesterol measurement; and the Population Panel Report, which set forth a public health approach to preventing heart disease; as well as by the 1991 Children's Panel Report. Together, these four reports provide the basis for the National Cholesterol Education Program's strategy to control high blood cholesterol in Americans.

A second adult treatment panel report by the National Heart, Lung, and Blood Institute (1996) reaffirmed that an increased blood LDL-cholesterol level increases a patient's risk of coronary heart disease (CHD), while lowering total cholesterol and LDL-cholesterol levels reduces CHD risk. According to practice guidelines, the following two approaches are indicated to lower Americans' blood cholesterol levels: 1) a clinical approach that defines high-risk individuals requiring intensive intervention efforts, and 2) a public health approach designed to shift the distribution of cholesterol levels in the entire population to a lower range through dietary changes.

According to this second report, clinical trials demonstrate conclusively that lowering serum cholesterol reduces cardiovascular morbidity and mortality in patients with established CHD. In addition, pooling of data from available clinical trials revealed a definite trend toward decreased total mortality in these patients. Clinical trial data have not yet produced evidence of improved outcomes for patients at high or moderate risk of CHD.[5] An outcome measure used by providers and insurers may include the percentage of the population being screened. Important to note, however, is that this measure is meaningless if the quality of the laboratory's cholesterol testing is poor.

Once a practice guideline is published and disseminated, people assume medical care will change, but this is not necessarily true. Most efforts in guideline development focus on local/organizational settings, where protocols are developed for a specific diagnosis or treatment. Medical specialty societies voluntarily produce their own guidelines in addition to those produced by federal agencies. Indications for lab tests may be identified in guidelines for admissions, discharges, and specific days of stay. Whether guidelines are developed and implemented at the national or local level, however, their publication results in a new accountability for the healthcare team in patient management and ongoing outcome assessment. Pathologist involvement is crucial as decisions are made on what lab tests should be included in these guidelines and when they should be ordered. Such efforts will ensure the correct lab tests are performed at the correct times for the correct reasons.

Laboratory outcomes

Once managed care capitated contracts are fully implemented and practice guidelines are developed and implemented, continuous performance improvement becomes crucial. The laboratorian's role in these efforts is paramount. Consequently, we must begin to develop laboratory outcome measures, data collection, and assessment to provide consumers with evidence of lab quality and cost effectiveness. Final laboratory outcome is based on whether the intended clinical need and objective for a particular test are met insofar as contributing to the diagnosis, treatment, and monitoring of a condition, as well as on the physician's, patient's, family's, and payer's satisfaction with lab services and their cost effectiveness.

Unfortunately, the clinical lab does not have access to a feedback loop relating lab participation to outcomes in patient care processes. While the physician's level of satisfaction with the lab is determined based on turnaround times, quality, and reliability, it is difficult to discern how useful a lab test was in the actual diagnosis, monitoring, and treatment for which the test was indicated and ordered. Furthermore, patients only base their satisfaction of the lab's involvement on such things as specimen collection and wait times.

Lab professionals are developing feedback loops designed to indicate payer satisfaction with cost/cost effectiveness; however, some laboratorians encounter barriers preventing their involvement in this area. Identifying and understanding these barriers, and others, will help develop strategies to overcome them.

Principal barriers

The primary barriers preventing progress in outcome assessment in the clinical lab are as follows:

Lack of information. Laboratorians are not privy to information about the clinical indication for a test and how it will be used; therefore, it is impossible for staff members to determine whether the test result helped a physician diagnose, treat, and/or monitor the patient.

Lack of time. With the fast pace of consolidations, new technology, and downsizing affecting lab operations, it is difficult for lab professionals to devote time to the development of studies, outcome indicators, and data collection, especially if data must be retrieved from medical records or other hard copy files.

Limited information systems. Lack of information and time are closely linked to limitations in the lab's information systems. When confronted with the task of data collection across boundaries in a facility, lab workers find their information systems lack integration and capability regarding the storage and retrieval of needed information.

Unclear objectives. Some laboratorians don't have clear objectives about outcome assessment. What the lab plans to measure and how it plans to categorize data will affect results and conclusions associated with a study. Lack of involvement by appropriate staff members may result in unclear objectives and flaws in data collection and categorization.

Small population. Studies with small numbers of patients limit the laboratorian's ability to draw valid conclusions.

Population data. Many problems are associated with applying outcome assessment to population data, including the inappropriate timing of samples.[6]

Overcoming barriers

Despite the barriers outlined above, laboratorians can successfully study and evaluate departmental outcomes. Below is a step-by-step approach to success:

1. Form a multidisciplinary team consisting of laboratorians and physicians with experience in epidemiologic/clinical studies and statistics. This knowledge is necessary to avoid the pitfalls associated with categorization and analysis of population data.

2. Design and conduct a systematic, multidisciplinary clinical study. Identify the disease process selected for the study and the time frame and criteria for selection of patients. Outcome measures developed for the study may then be related to recovery, improvement, complications, disability, and death, and can be reported as a rate (proportion of the ill that recover, become disabled, or die per unit of time).

3. Develop clear and measurable study objectives, including criteria for categorization of cases and data. These objectives will provide the focus necessary for data collection and analysis.

4. Ensure the team understands the extended process. It is important that members comprehend inputs (i.e., activities that require ongoing effort on the part of study participants, such as the acquisition and analysis of data) and processes because outcome reflects the total effects of all inputs in the process of care. Inputs and processes are modified and changed to affect outcome. Any number of assessment tools can be used to summarize and clarify this knowledge. Outlining the processes involved in a particular outcome (see table p. TK) allows a very concise summary of inputs, processes, and output.

5. Review current literature available on your study topic, including information on the predictive value of tests associated with different populations and the clinical pathological correlation of the test or service. Comparing test utilization patterns with these published data or published practice guidelines may indicate opportunities for more appropriate ordering practices. Laboratorians on the Dallas Children's Hospital TDM team found that tests were not always ordered and collected according to the intended use and methods published for those tests. A recent study noted that only 27% of antiepileptic serum drug concentrations were appropriately indicated, and 51% were not sampled at appropriate times.[7]

6. Design systems for data collection, including information system queries, outcome indicators, and reports. Unfortunately, these data may only be available on multiple systems or on hard copy. The Dallas TDM study resulted in the development of a report generated from the lab system so clinical pharmacists could perform a more timely concurrent data review and collection as opposed to retrospective chart review.[8] As an added bonus, this computer report also opened new channels of communication between lab staff and clinical pharmacists.

7. Collect, calculate, and assess data. Formulate conclusions by developing an action plan, which may lead to the development of ordering protocols or guidelines, education of staff and physicians, changes to test systems and services, rules or algorithms for reflex testing, the development of check sheets to better categorize data, and other changes associated with the process of care or inputs.

8. Continue data collection and assessment for outcome indicators to ensure change is sustained. Teams must continuously change inputs or processes upstream, implement their action plan, collect data for process and outcome indicators, assess outcome, and seek improvement.

Be part of the process

Regardless of our roles and responsibilities in the lab, we must continue to learn more about epidemiology. or statistics, enhance knowledge and skills in data management, and volunteer to work or lead a team project. Outcome assessment and improvement can only be accomplished when a healthcare team focuses on questions related to outcomes and applies a structured, well-planned scientific approach.

Whether the goal is performance improvement, cost reduction, or employing best practices, laboratorians can help improve the timeliness and accuracy of clinical decisions made for diagnosis and treatment alternatives that determine patient outcome. The laboratory's future role in the healthcare system is being determined in these terms. Laboratorians must be a part of the process.


Processes, including input and output, for therapeutic drug monitoring (TDM)


1. Indication

First evaluation Correct dosage interval Correct dose Disease Drug interaction

2, Drug administration

Dosage Dosage interval Time of dose

3. Blood collection

Steady state Collection time Patient ID Sample ID Specimen type

4. Serum drug testing

Timeliness of results Analytical system

5. Interpretation

Dosage interval Dosage


6. Optimum therapeutic effect of drug


1. Donabedian A. The role of outcomes in quality assessment and assurance. Quarterly Review Bulletin. 1992;18(2):356-359.

2. Joint Commission on Accreditation of Healthcare Organizations. Scoring guidelines. In: Accreditation Manual for Hospitals. 2nd ed. Oakabrook Terrace, III: JCAHO; 1996: 173.

3. Ware J, Sherbourne C. The MOS short-form health survey (SF-36). Med Care. 1992;30:473-483.

4. Aday L, Begley C, Lairson D, Slater C. Effectiveness: Evidence and an application. In: Evaluating the Medical Care System: Effectiveness, Efficiency, and Equity. Washington D.C.: Health Administration Press; 1993: 63-64.

5. Gitlow H, Gitlow S, Oppenheim A, Oppenheim R. Documenting and defining a process. In: Tools and Methods for the Improvement of Quality. Milwaukee: Irwin Inc.; 1989: 38-53.

6. Friedman G. How to carry out a study. In: Primer of Epidemiology. New York, NY: McGraw Hill Inc; 1987: 215-231.

7. Schoenenberger RA, Tanasijevic MJ, Jha A, Bates DW. Appropriateness of antiepileptic drug level monitoring. JAMA. November 1995;274 (20): 1622-1626.

8. Jones H, Lindsay C, Ballard T. Improving outcomes in TDM: A case history. Clin Lab Manage Rev. 1996;10(2):160-166.

Michael G. Bissell is the director of clinical pathology, Allegheny General Hospital, Pittsburgh, Pa. Harvey Jones is the department director of pathology/laboratory medicine, Children's Medical Center, Dallas.
COPYRIGHT 1998 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998 Gale, Cengage Learning. All rights reserved.

Article Details
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Author:Bissell, Michael G.; Jones, Harvey
Publication:Medical Laboratory Observer
Date:Jan 1, 1998
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