HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE), v0.9.0

Publish Box goes here

Laboratory Results and Vital Signs

 

Core Laboratory Results

Laboratory panels and results encompass a breadth of diagnostics across many different subspecialties. Given the need for greater scoping, we identify mCODE™ are scoped to the core set of labs ordered as part of an initial diagnostic workup, regardless of disease type.

The initial mCODE release includes:

  • Complete Blood Count (CBC) with Automated Differential
  • Comprehensive Metabolic Panel (CMP)

These core diagnostic labs are modeled separately from cancer-specific serum and tissue-based prognostic factors which in some cases, are essential for cancer diagnosis and staging. These prognostic factors are modeled as a dedicated FHIR profile for tumor marker observations.

Tumor Markers

Tumor markers are key prognostic factors in calculating cancer staging, identifying treatment options, and monitoring progression of disease. This IG distinguishes tumor markers from genetic markers as follows:

  • Tumor markers can be indicators that result from the existence of cancer process. For example, an abnormal increase in prostate-specific antigen (PSA) levels is a prognostic factor for prostate cancer. Other tumor markers include estrogen receptor (ER) status, progresterone receptor (PR) status, carcinoembryonic antigen (CEA) levels, among others.
  • Genetic markers are measured at the DNA, RNA, or chromosomal level. Genetic tests which evaluate molecular markers include but are not limited to in-situ hybridization tests (e.g.: FISH, CISH), sequencing tests (e.g.: Sanger, NGS), whole genome and exome tests, and karyotype. Genetic markers are addressed in the Genomics Reporting section.

 

Vital Signs

By definition, vital signs are measurements of the most essential, or "vital" body functions. Traditionally, the essential vital signs are temperature, heart rate, breathing rate, blood pressure. Both definition and the inclusion of measurements included in a vital signs panel have evolved over time to loosely include a set of measurements performed directly on a patient and help inform assessment and treatment options, sometimes including height, weight, and pain scales.

mCODE limits the list of vital signs to those which drive the calculation of a body mass index (BMI) to determine an absolute dose in a given treatment and at the time of administration. For the initial mCODE release, these include:

  • Body height
  • Body weight
  • Blood pressure