Diagnostic Excellence Initiative

Introduction

Accurate and timely medical diagnoses support public health and patient care. In a 2015 report, "Improving Diagnosis in Healthcare," the National Academies of Medicine identified diagnostic error as a major public health challenge.1 Annually, approximately 800,000 Americans die or become disabled due to diagnostic errors associated with serious conditions that include cancer, cardiovascular, and infectious diseases.12 These diagnostic errors contribute to about one-third of all medical errors.

The Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems (DLS) established the Diagnostic Excellence Initiative to incorporate laboratory expertise and capabilities into a diagnostic excellence enhancement strategy3.

The Total Testing Process

The Total Testing Process (TTP) in clinical settings is a step-by-step plan that guides everything from asking the right medical question and the correct test, to collecting the sample, analyzing it, and interpreting the results. By following these steps, healthcare teams support accurate diagnoses and promote patient safety.

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Phases of the Total Testing Process

• Pre-analytic Phase: Steps that occur prior to testing of the patient sample that begins with an indication for testing and concludes with specimen receipt, assessment, and accession.
• Analytic Phase: Steps that occur during testing of the patient sample that includes sample preparation, sample testing, and subsequent data analysis, laboratory interpretation and reporting.
• Post-analytic Phase: Steps that occur after testing of the patient sample that includes clinical interpretation and follow-up.

The following video demonstrates the TTP framework, using kidney function and disease testing as an example.

Key Areas Supporting Diagnostic Excellence

The Initiative advances diagnostic excellence through four closely linked focus areas:

• Enhancement of testing procedures and laboratory workflows to ensure accuracy and efficiency.
• Systematic evaluation of laboratory practices, fostering continuous improvement and adherence to high quality standards.
• Development of comprehensive policies, guidelines, and best practices to guide laboratory operations.
• Emphasis on educating patients and healthcare professionals, empowering them with the knowledge necessary to improve patient outcomes and support informed decision-making.