CDC and Battelle are seeking laboratories willing to share unpublished studies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relevant unpublished evidence is produced from quasi-experimental studies (e.g.,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.
How the Pilot Test will work:
Data provided to CDC and Battelle
- CDC will invite laboratories with previously completed unpublished studies or assessments in the two topic areas, to participate in the methods pilot test. These laboratories will provide unpublished evidence on practices that will be assessed using the same methods as the published studies.
- 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 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the two Expert Panels and pilot study sites, will identify, assemble, abstract, and evaluate evidence—published and unpublished—concerning the effectiveness of the candidate practices.
- The Expert Panels will review the entire body of evidence for each practice, published and unpublished, and draft a summary evaluation of the strength of evidence and effect size to support an evidence-based recommendation.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).
No “new” data collection is requested from participating laboratories; the pilot test will focus entirely on previously completed data collection and evaluation efforts that provide information about the effectiveness of specific practices. No patient-specific data or personal health information will be requested. Individual laboratories, hospitals, hospital systems, clinics, or other institutions will have the option to be identified as participants or remain anonymous in publications or summaries describing the pilot test and its findings.
Responsibilities for participating laboratories
Participation in the pilot test will be by invitation from the CDC. The single most important criterion for selecting laboratories to participate will be availability of relevant unpublished information, preferably in the form of a study on practices in one or both of the topic areas.
LMBP Network Participants Guidance Tool
Participating organizations will be asked to:
Benefits of participation:
- Designate a senior laboratory scientist, laboratory director, or other appropriate staff as the primary contact for requesting information regarding availability of potential studies
- Identify and manage requirements necessary to provide requested information, potentially including an Institutional Review Board process
- Submit requested specific, de-identified information to CDC
Your facility will benefit from the exchange of information with colleagues in other laboratories about best practices and the type of supporting information for the use of these practices. This will contribute to your facility's quality improvement efforts, support purchase of new technology, and improve laboratory processes and organization.
Costs of participating
The primary costs to organizations participating in the pilot test will be the time of the laboratory director or senior scientist who is designated as the primary study contact, and the time of other personnel involved in identifying, and submitting unpublished studies. No other significant costs are anticipated.
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: