Lab Formulary Committee
Statement of Ethical Principles
Approved January 8, 2015
The Lab Formulary Committee, a subcommittee of the Pharmacy, Therapeutics, and Diagnostics Committee, was chartered by the Medical Center Medical Board to develop and implement a laboratory formulary to guide laboratory ordering at VUMC. Improving patient care, promoting the application of evidence-based, cost-efficient laboratory testing, and protecting patients from the possible consequences of inappropriate or unnecessary testing are important goals of the Lab Formulary Committee. The guiding principles of the laboratory formulary decision-making process are (1) ensuring high-quality patient care and (2) providing unbiased, evidence-based recommendations regarding the appropriate use of laboratory tests.
Evidence-Based Review
The Lab Formulary Committee acknowledges the continually-evolving nature of clinical evidence and its application to practice. All Lab Formulary Committee recommendations will be based on thorough evidence review and the consensus of VUMC content experts. An authoritative compendium of evidence-based reviews will be used to allow, restrict, or eliminate laboratory tests. Pertinent clinical and diagnostic guidelines will be considered by the committee before reaching a consensus.
At least one subject expert will participate in subcommittee and committee discussion(s) pertaining to a particular practice or set of guidelines before a recommendation or decision is finalized. Stakeholders, including practicing clinicians, medical directors of the clinical laboratories, and clinical laboratory administrators, will be consulted to advise on the value of the laboratory tests to patient care.
Ongoing evidence review and dialogue with the provider community are cornerstones of the formulary process. Exceptions to and appeals of Lab Formulary Committee recommendations will be considered.
Sufficient Incremental Value
A laboratory test should be ordered only when it is both medically necessary and likely to alter the diagnosis or treatment plan. Laboratory test results should contribute sufficient incremental value to the care of the patient to justify performing the laboratory test. Value may be defined as the ability to significantly impact treatment decisions or change individual patient management, to diagnose a previously undiagnosed condition, or to protect patient safety.
Incidental Findings
Laboratory information should be used to make appropriate, evidence-based diagnostic or therapeutic decisions. Neither clinicians nor laboratory directors or staff will actively search for findings outside of the clinically-indicated target(s) of the laboratory test. Incidental findings, defined as only those findings that are discovered without deliberate, additional search, particularly in the setting of clinical exome and genome sequencing, will be reported only if there is strong evidence of benefit to patient care, which includes disorders where preventative measures and/or treatments are available.