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Biomarker Symposium 2013

Harmonization of Clinical Laboratory Results Presentation

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Biomarker Standardization Symposium Outcomes / Statement
The Cardiovascular Biomarker Standardization Steering Committee of the National Association of Chronic Disease Directors (NACDD) and the Clinical Chemistry Branch of the Centers for Disease Control and Prevention (CDC) held a symposium for health care professionals concerned about high quality patient care. This symposium "Delivering Cost Effective, High Quality Patient Care through Accurate and Reliable Laboratory Testing” - was held in Atlanta, Georgia on May 15, 2013.

Based on the premise that standardized, accurate and reliable laboratory tests help assure high quality patient care by ensuring appropriate and effective diagnosis and treatment of patients. The objectives of the symposium were to:

  1. Inform stakeholders about the importance of standardized, accurate and reliable laboratory tests to assure appropriate and cost effective patient care; and
  2. Familiarize stakeholders with standardization processes and the organizational structure of the Clinical Chemistry Laboratory of CDC's Division of Laboratory Sciences.
Nationally recognized speakers presented information on various aspects of the importance of standardized blood tests, including:
  • How standardization/harmonization affects the quality of patient care, research translation, public health;
  • How the CDC Lipid Standardization Program results in cost savings and how standardized lipid testing saves lives;
  • HbA1c standardization as an example of how appropriate biomarker measurements improve the quality of patient care;
  • Creatinine standardization as an example how accurately calibrated tests improve clinical decisions;
  • Impact of test variability on diagnosis and prevalence, using variability in LDL testing; and
  • The value of accurate and comparable diagnostics from a health systems perspective and its influence on the direction of health care policy.
At the conclusion of these presentations, a discussion that summarized the key observations produced the following barriers to improving standardization of cardiovascular and other chronic disease diagnostic tests and opportunities to improve the accuracy and reliability of these tests.

Barriers to Improved Standardization
  • Clinical practitioners, patient advocates and the general public assume that all is well with blood tests.
  • There is a fragmentation of effort within the clinical chemistry community to advance standardization of cardiovascular biomarker tests.
  • Medical, clinical chemistry and public health community members are not coordinated in efforts to inform other stakeholders (e.g., patient advocacy groups, policy makers, health plan managers) about the relationship between standardization and quality health care and to help advocate for standardization.
  • Coordination among clinical chemistry community leaders is improving for cholesterol, but coordination for other biomarkers is slow.
  • There is a lack of awareness regarding standardization and its association with quality of health care.
  • Lack of dedicated funding for the work of standardization (i.e., research and development) is a barrier to progress.
  • The research community often identifies new biomarkers that may not have clinical applications and journals publish this research.
  • CMS policies do not reflect cost of tests.
Opportunities to Improve Accuracy and Reliability
  • The Accountable Care Organization model (shared savings) changed the paradigm to control costs.
  • Standardization reduces misclassification (e.g., missed diagnoses and over diagnoses)
  • Quality of care institutes (regional and national) can increase health care quality through improved standardization.
  • National cut-points for disease and early identification can be more clearly defined with high quality, accurate and reliable standardized blood tests. (e.g., HbA1c now has cut-points for diagnosis of diabetes and pre-diabetes.)
  • Identify and enlist all stakeholders (the downstream consumers) for improved quality and reliability of blood testing to become advocates for change. (e.g., clinical societies, patient advocacy organizations)
  • Tailor messages regarding the importance of standardization to public health, clinical, industry and policy maker groups.
  • Deliver tailored messages about the importance of standardization using methods that are continuous, persistent and inescapable.
  • Identify and prioritize key biomarkers that are in need of standardization and have action plans. (i.e., Identify a pipeline of biomarkers.)


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