Purpose & Rationale

CDC has adapted review frameworks and methods currently in use in medicine and public health to laboratory medicine. Reference sources for methods development included the US Preventive Services Task Forceexternal icon, the (CPSTF) Community Preventive Services Task Forceexternal icon, and other groups that issue evidence-based recommendations. The LMBP systematic review methods have been developed and pilot-tested over a three-year period across three quality improvement topics:

• Patient specimen identification
• Critical test value communication
• Blood culture contamination

An outcome of Phase 1 (2006 – 2007) was to act on a Workgroup recommendation and enlarge the search for evidence to unpublished studies, including assessments performed for the purposes of quality assurance, process improvement and/or accreditation documentation.

Phase 2 (2007-2008) involved a pilot test of further refined methods to obtain, review, and evaluate published and unpublished evidence, along with collecting observations via key informant interviews about organizational and implementation issues successfully addressed by other recommending bodies about the development and dissemination of guidelines and best practice recommendations. These evidence review methods were adapted from those established by the GRADE group, The Guide to Community Preventive Services (Community Guide), the Agency for Healthcare Research and Quality (AHRQ) (US Preventive Services Task Force (USPSTF), Evidence-based Practice Centers (EPCs), and Effective Healthcare Program), and others, and modified to better accommodate the non-controlled study designs typically found in quality improvement research.

Phase 3 (2008-2010) involved further development of methods for identifying evidence-based laboratory medicine quality improvement best practices, and validated these methods with reviews of practices associated with three topics: patient specimen identification, critical value reporting, and reducing blood culture contamination.

Phase 4 (2009-2011) involved extensive education, outreach and engagement activities to expand the network of facilities and organizations willing to provide unpublished evidence for the purposes of supporting best practice recommendations, and improve CDC’s capacity to search for sources of relevant unpublished evidence, and finalizing review and evaluation methods with results of this effort reported in manuscripts for peer review publication.

Phases 5 and 6 (2010-present) have continued education, outreach, and engagement activities, including piloting a capacity-building project with a key organizational partner, the American Society for Microbiology, and we have focused on incorporating implementation-related considerations into newly initiated evidence reviews. We prepared four evidence review manuscripts for publication in a special issue (September 2012) of Clinical Biochemistry. Two other evidence reviews are in preparation, and three new systematic review topics will be selected in December 2012.