ABOUT THE LABORATORY MEDICINE BEST PRACTICES INITIATIVE
The Division of Laboratory Systems (DLS) and Battelle Memorial Institute (Battelle) are carrying out a multi-year project to develop methods to systematically review, evaluate, and make evidence-based best practice recommendations for laboratory medicine. Methods development and current pilot testing is carried out under the guidance of an external multi-disciplinary Laboratory Medicine Best Practices Workgroup.
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.
One exception are evidence based guidelines developed by the National Association of Clinical Biochemistry for the application of clinical biochemistry to medical diagnosis and therapy.
1)Institute of Medicine. To Err is Human: Building a Safer Health System (1999).
2)Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century (2001).
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 guide the development and pilot test of methods to systematically review and evaluate evidence for making practice recommendations.
CDC and Battelle have utilized review frameworks and methods currently in use in medicine and public health and have adapted these approaches to laboratory medicine. Reference sources for methods development included the US Preventive Services Task Force and the Task Force on Community Preventive Services, as well as other entities that issue evidence based recommendations. Three key components of the LMBP Review and Evaluation Methods are:
- Systematic Evidence Reviews – standardized steps to collect, screen, and synthesize the relevant evidence of effectiveness
- Evidence Evaluation – based on methods developed to rate the individual studies and then aggregate them into an overall body of evidence which is rated by an independent expert panel using pre-specified criteria
- Best Practice Recommendations - the evidence review and evaluation then becomes the basis for best practice recommendations
In Phase I of the project (2006 – 2007), The CDC / Battelle Research Team with guidance from the LMBP Workgroup piloted methods to conduct systematic evidence reviews. Key steps were:
- Establishing key terms and definitions
- Developing inclusion/exclusion criteria for laboratory medicine practices
- Identifying topic areas for candidate practices
- Developing systematic review methods to assess and evaluate published studies
- Drafting an evaluation framework for making 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. This exercise highlighted the limitations of the scant peer-reviewed published evidence base for patient specimen identification practices (and laboratory medicine practices generally). Workgroup members recommended adding an "investigational component" to the methods to identify unpublished evidence such as in-house quality improvement studies.
Workgroup recommendations and findings from the phase 1 development are included in the Final Report Phase 1: Laboratory Medicine Best Practices: Developing an Evidence-Based Review and Evaluation Process
In Phase II of the project (2007-2008), The CDC / Battelle Research Team with guidance from the LMBP Workgroup piloted methods to review, evaluate and make evidence based practice recommendations using two topics. Objectives for Phase II were to:
- Create a pilot LMBP laboratory network to acquire unpublished evidence
- Develop criteria and methods for evaluating published and unpublished evidence of effectiveness
- Pilot test methods
- Evaluate organizational structure alternatives for implementation of the LMBP review and evaluation process
Pilot Systematic Evidence Reviews were conducted in Phase II, 2008 using the topics: reduction of patient specimen identification errors and critical values reporting and communication. Laboratories with previously completed unpublished studies or assessments in the two topic areas were invited to participate in a pilot LMBP Network and submit their in house assessments for these topics. Unpublished evidence on practices submitted by these laboratories was assessed using the same criteria as for the published studies.
To guide the review of evidence, CDC and Battelle convened Expert Panels for each topic comprised of members with training in evidence evaluation and laboratory operations. For the pilot test, the role of Expert Panelists was to: assist in the development and validation of protocols for collecting unpublished and published evidence and to rate evidence using pre-specified criteria.
For the purposes of the pilot test, the Laboratory Medicine Best Practices Workgroup participated as a "Recommending Body." The Workgroup reviewed 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).
A Phase II Final Report is forthcoming which will provide information on the findings of the pilot test and LMBP methods development.
Phase III (2008-2009)
For the project’s third phase, CDC and Battelle will refine and test evidence review and evaluation methods using additional topics. To learn more about the pilot test network and how your laboratory can participate, visit: Pilot Test Network.