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 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.
References
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:
- 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.
- Make recommendations for improving the effectiveness of PT in meeting regulatory, educational, and quality improvement objectives.
- 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.
- 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