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Improving Quality in Laboratory Medicine
  Quick Links
arrow Project Background
arrow Laboratory Medicine: A National Status Report, 2007
arrow Identifying and Evaluating Best Practices in Laboratory Medicine
arrow Final Report of Phase 1 - Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process
arrow Participation in Pilot Test Network
arrow Memo of Understanding with CLMA
arrow 2007 Proficiency Testing Report
The Division of Laboratory Systems (DLS) is leading a national effort to identify and evaluate best practices in laboratory medicine. This project has three major goals:
  • Improve patient safety and health care outcomes by improving the use of laboratory testing in screening, diagnosis, monitoring, and management of disease
  • Reduce redundancy and waste in laboratory services
  • Provide tools that laboratories can use to improve quality of service to clinicians and patients
The Division of Laboratory Systems’ initiative includes:
  • A report on the current status of laboratory medicine in the United States, which provides a detailed overview of the key factors affecting the field of laboratory medicine today and those that will shape the field in the coming decades.
  • Development of evidence-based methods to identify and evaluate Best Practices in Laboratory Medicine.
  • Network of laboratories and partnerships with key stakeholders in laboratory medicine to support identification and foster adoption of evidence-based Best Practices.
  • A report reviewing proficiency testing (PT) and the regulatory, educational, and quality improvement objectives of the Clinical Laboratory Improvement Amendments of 1988 (CLIA ′88).
Project Contacts: Centers for Disease Control and Prevention
Susan R. Snyder, PhD, MBA
Battelle Memorial Institute
Edward B. Liebow

Project Background

Health care expenditures per capita and as a percentage of gross domestic product (GDP) in the United States are the highest in the world. Most analysts expect that health care costs will continue to rise above the rate of inflation as the nation’s population ages and technology advances. Increased spending on health care has not produced commensurate improvements in access to health care, health outcomes, or the quality of services delivered by the health care system. Several sentinel studies, including two reports from the Institute of Medicine (IOM) (1,2), highlighted the need for improvements in the safety and quality of American health care. These studies spurred government agencies, professional associations, private insurers, foundations, academic institutions, and others to initiate quality improvement efforts in almost every arena of health care. In a newly issued report, the IOM recommends systematic reviews of evidence on the effectiveness of health services as the central link between evidence and clinical decision making, as individual studies rarely provide definitive answers to clinical questions (3).

Laboratory testing is an integral part of modern medical practice, and laboratory medicine confronts the same challenges of quality, cost, and access as the larger health care system. Over 200,000 clinical laboratories are certified to operate in the United States by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which set minimum standards for clinical laboratory testing. These laboratories conduct more than 7 billion tests per year (4). Although laboratory testing accounts for only about 2.3% of annual health care costs in the United States (5), the influence of laboratory medicine on the quality and cost of health care as a whole is much greater because laboratory test results influence the majority of patient care decisions (6,7). Thus, practices that reduce laboratory-related error rates or optimize use of laboratory testing can have a substantial effect on patient safety, clinical decision making about treatments and interventions, health outcomes, and costs.


Laboratory Medicine: A National Status Report, 2007

CDC commissioned The Lewin Group, under subcontract to Battelle Memorial Institute, to produce a comprehensive overview of the current state of laboratory medicine. The report provides a detailed overview of the key factors affecting laboratory medicine, including
  • Value of laboratory medicine to the U.S. health care system
  • Market profile of the laboratory medicine sector
  • Laboratory medicine workforce
  • Quality and the total testing process in the clinical laboratory
  • Quality systems and performance measurement
  • Laboratory information systems
  • Federal regulatory oversight of laboratory medicine
  • Reimbursement for laboratory medicine
Laboratory Medicine: A National Status Report, 2007

Comments on this report may be submitted to the Lewin Group

The Lewin Group is preparing an update to the report for 2008 that will focus on areas including:
  • Role of laboratory testing in patient-centered care
  • Impact of emerging testing technologies on clinical laboratory practice
  • Policy issues and their implications for stakeholders in laboratory medicine

Identifying and Evaluating Laboratory Medicine Best Practices

CDC and Battelle are conducting a pilot test of methods for evidence-based evaluation of best practices in laboratory medicine. This pilot test will add to a larger effort spearheaded by DLS that has three major goals:
  • Improve patient safety and health care outcomes by improving the use of laboratory testing in diagnosis, monitoring, and management of disease
  • Reduce redundancy and waste in laboratory services
  • Provide tools that laboratories can use to improve quality of service to clinicians and patients
A comprehensive approach to evaluating best practices is needed in laboratory medicine because laboratory test results influence a large percentage of diagnostic and patient care decisions in modern medical practice. Conversely, quality in laboratory medicine is affected by multiple processes and factors, many of which are not under the control of laboratorians. Laboratory errors and inappropriate laboratory testing (under use, overuse, misuse) thus have ramifications that extend beyond the walls of the laboratory and affect many aspects of medical care. Opportunities for error exist at many points in the total laboratory testing process, and have been found to occur at higher proportions in the pre- and post-analytic stages. These include selecting and ordering appropriate clinical tests, obtaining patient specimens, reporting results to clinicians, and interpreting laboratory results.

In response to the systemic shortcomings in health care quality identified by the IOM (1,2) and others, evidence-based recommendations, guidelines, and quality measures have been developed in many fields of medicine. The Agency for Healthcare Research and Quality (AHRQ) compiles this information in its National Guidelines Clearinghouse and National Quality Measures Clearinghouse. Many disease-specific guidelines and quality measures for screening, diagnosis, treatment, and management include recommendations for laboratory testing. Laboratory medicine guidelines and measures that satisfy AHRQ’s inclusion criteria may be included in these databases, however relatively few have met the criteria.

In laboratory medicine, previous efforts to develop guidelines, standards, policies, and best practice recommendations served specific fields or professions in the laboratory community. The College of American Pathologists (CAP), the Clinical and Laboratory Standards Institute (CLSI), and the Clinical Laboratory Management Association (CLMA), among others, have developed approaches to recommending and disseminating quality practices. Recognizing the need for a more systematic, comprehensive, and transparent approach to identifying, evaluating, and recommending best practices for the field as a whole, CDC convened an expert multi-disciplinary Laboratory Medicine Best Practices Workgroup in October 2006. DLS charged the Workgroup to identify systematic review frameworks and methods that are currently in use in medicine and public health, and to adapt these approaches to the field of laboratory medicine. The Workgroup’s efforts were supported by a team of researchers from DLS and Battelle.

Phase I

In 2006 and 2007, the study team developed methods for evaluating candidate best practices which included an analytic framework, search strategy, practice and study inclusion criteria for selecting practices and developing an evidence base, and systematically abstracting and summarizing the evidence. Reference sources included the US Preventive Services Task Force and the Task Force on Community Preventive Services, as well as others, for assessing the strength of individual studies and of a body of evidence that have been used to develop evidence-based recommendations.

To test these methods, the research team and Workgroup conducted a "proof of concept" exercise that focused on practices to reduce patient/specimen identification errors in laboratory testing. As the proof-of-concept exercise proceeded, the limitations of the scant peer-reviewed published evidence base for patient/specimen identification practices (and laboratory medicine practices generally) became increasingly apparent. Workgroup members believed that laboratories conduct case studies, evaluations, and quality improvement studies. Typically, these studies are not published and thus are not accessible by conventional bibliographic searches. The Workgroup recommended adding an "investigational component" to the process to identify, obtain, and evaluate unpublished evidence from practitioners, laboratories, and expert groups. As recommended by the Workgroup, the criteria and methods for evaluating this expanded evidence base should parallel those applied to evidence from published sources, and should be specified beforehand.

Final Report Phase 1: Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process

Phase II

For the project’s second phase, CDC and Battelle will pilot test the investigational component, evidence review and evaluation methods. The pilot test will focus on identifying and evaluating specific practices in two topic areas: patient/ specimen identification and communication of critical laboratory test values. Battelle and CDC will assemble two Expert Panels with appropriate training and experience in evidence evaluation and laboratory operations, one for each topic area. The Expert Panels will define specific parameters for research questions and practices to be evaluated in each topic area.

CDC will invite laboratories with previously completed unpublished studies or assessments in the two topic areas, to participate in the methods pilot test. These laboratories will provide unpublished evidence on practices that will be assessed using the same methods as the published studies. CDC and Battelle scientists supporting the two Expert Panels and pilot study sites, will identify, assemble, abstract, and evaluate evidence—published and unpublished—concerning the effectiveness of the candidate practices. The Expert Panels will review the entire body of evidence for each practice, published and unpublished, and draft a summary evaluation of the strength of evidence and effect size to support an evidence-based recommendation. For the purposes of the pilot test, the Laboratory Medicine Best Practices Workgroup will act as a "Recommending Body." The Workgroup will review the draft summary statements and supporting documentation provided by the Expert Panels, to decide on recommendations concerning each practice (i.e., strongly recommend, recommend, no recommendation for or against, recommend against).

Pilot Test Network

CDC and Battelle are seeking laboratories willing to share unpublished studies or assessments on practices for patient specimen identification and/or critical value results reporting for the pilot test. Exploratory work suggests that such relevant unpublished evidence is produced from quasi-experimental studies (e.g., non-blinded trials), surveillance of error rates or other such objective outcomes initiatives over time, case studies, failure mode and effects analysis (FMEA), Six Sigma studies, continuous quality improvement (CQI), and other similar "in-house" studies.

Participation in Pilot Test Network

To learn more about participating in the pilot test network, click here: Participation in the Pilot Test Network

Memo of Understanding

DLS and the Clinical Laboratory Management Association (CLMA) have agreed to work together to promote adoption of laboratory practices that reduce laboratory testing errors and improve the quality of laboratory testing services. The agreement is an outgrowth of complementary initiatives undertaken independently by the two organizations. DLS’s "Identifying and Evaluating Best Practices in Laboratory Medicine" project aims to develop methods for identifying and systematically evaluating practices in laboratory medicine. CLMA’s "Good Practices Sharing" initiative encourages members to share successful laboratory practices with colleagues through a well-organized and easily accessible database.

Additional information
For additional information about CDC’s initiative to define best practices in laboratory medicine, or to volunteer your laboratory to participate in the pilot test, or if you have specific questions about the project, contact:

Pamela Thompson: 404-498-2753
Anne Pollock: 404-498-2750

Review of Proficiency Testing Services for Clinical Laboratories in the United States – Final Report of a Technical Working Group

In 2006, DLS assembled a thirteen-member Working Group to assess the effectiveness of clinical laboratory proficiency testing (PT) for regulatory, educational, and quality improvement purposes. Membership of the Working Group included PT users, PT providers, and representatives of accrediting organizations, but members were chosen for their expertise in PT and not as representatives of their employers, professional organizations or trade associations. DLS representatives charged the Proficiency Testing Working Group (PTWG) to accomplish four primary objectives:

  1. Report on the status of current clinical PT programs in the US, assessing the success of PT in improving the quality of clinical testing and identifying areas in which improvements are needed.
  2. Make recommendations for improving the effectiveness of PT in meeting regulatory, educational, and quality improvement objectives.
  3. Solicit and consider input from stakeholders including PT providers, PT users in several types of clinical laboratories, and accrediting organizations. Assess the feasibility of recommended changes.
  4. Identify needed improvements to PT that could be addressed during the next five years.
In response to a series of questions posed by DLS management, the PTWG sought input from stakeholders and formulated recommendations to CDC. Battelle, as CDC’s contractor, drafted the final report, which was reviewed by PTWG members. Recommendations reflect the majority views of the Work Group, but not formal consensus.

2007 Proficiency Test Report

This page last reviewed: 4/8/2008
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