Lithuanian Laboratory Implementation Guide
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Lithuanian Laboratory Implementation Guide, published by Lithuanian Medical Library. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7LT/ig-lt-lab/ and changes regularly. See the Directory of published versions

Artifacts Summary

This page provides a list of the FHIR artifacts defined as part of this implementation guide.

Clinical Chemistry

Clinical Chemistry observations and related profiles

Cholesterol HDL

Observation representing the patient's high-density lipoprotein (HDL) cholesterol concentration in serum or plasma.

Cholesterol LDL

Observation representing the patient's low-density lipoprotein (LDL) cholesterol concentration in serum or plasma, measured either directly or by calculation.

Cholesterol LDL Method

Allowed LOINC codes for LDL cholesterol measurements (direct or calculated).

Cholesterol Non-HDL

Observation representing the patient's non-HDL cholesterol concentration in serum or plasma, calculated as total cholesterol minus HDL cholesterol.

Cholesterol Total

Observation representing the patient's total cholesterol concentration in serum or plasma.

Glucose in Venous Blood

This profile constrains the Observation resource to represent glucose concentration in venous blood.

Lipidogram (Lipid Panel – Serum or Plasma)

Lipid panel (Lipidogram) including Total Cholesterol, LDL-C, HDL-C, and Triglycerides.

Triglycerides

Observation representing the patient's triglyceride concentration in serum or plasma, used to assess lipid metabolism and cardiovascular risk.

Glycemic Control

Glycemic Control observations and Diabetes Monitoring

HbA1c. Glycated Hemoglobin Test

Observation representing Glycated Hemoglobin (HbA1c) test results in blood, reported as a percentage.

Renal Function

Renal Function (Kidney) Panel

Albumin/Creatinine Ratio (ACR)

Observation representing the urine albumin-to-creatinine ratio (ACR), used to assess kidney function in diabetic patients.

Creatinine Test

Observation representing the patient's serum or plasma creatinine concentration.

eGFR

LOINC codes representing eGFR measurement methos calculated using CKD-EPI formulas (original and 2021 revision).

Observation: Lab - eGFR

Observation representing estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI or CKD-EPI 2021 formula.

Pathology

Pathology orders, reports, and related profiles

Composition: Pathology Document (LT Lab)

Synoptic pathology Composition with four fixed LOINC-coded sections (Pre-Analytic, Macro, Micro, Synthesis). Each top-level section and each nested subsection must carry a human-readable Narrative for clinicians, alongside references to supporting resources.

Condition: Prostate Cancer

A profile on Condition for Prostate Cancer with staging for TNM and morphology.

Observation: Her2 Receptor Status

Definition of the Observation for the Her2 receptor status

Pathology Procedure

SNOMED CT procedure codes for classifying pathology diagnostic reports (cytology, histology, screening, autopsy).

Procedure: Biopsy (LT Lab)

Biopsy procedure performed for histopathological examination. Captures the surgical collection of tissue specimens for laboratory analysis, including biopsy type, body site, and links to collected specimens.

ServiceRequest: Pathology Order (Lt)

This profile defines how to represent an pathology orders.

ServiceRequest: Pathology Report (Lt)

This profile defines how to represent an pathology report.

Specimen

Specimen and specimen-related observations

Observation: Specimen Adequacy

Definition of the Observation for the Specimen Adequacy.

Observation: Specimen Measurement

Definition of the Observation for the Specimen Measurement, which includes the physical measurements of the specimen and its number of lymph nodes.

Observation: Tumor Measurement

Definition of the Observation for the Tumor Measurement

Observation: Tumor Observable

Definition of the Observation for the Tumor Observable

Specimen (LT Lab)

This profile defines how to represent Specimens in HL7 FHIR for the purpose of this guide, based on the Specimen profile from HL7 Europe with additional constraints and extensions specific to the needs of the LT Lab use case.

Specimen: Tissue Block

A profile for paraffin-embedded tissue blocks derived from a parent specimen.

Substance: Specimen Additive (LT Lab)

This profile defines how to represent Specimen Additive Substances for the Lithuanian Laboratory IG, based on the EU Lab Substance Additive profile.

Structures: Resource Profiles

These define constraints on FHIR resources for systems conforming to this implementation guide.

Observation: Estrogen Receptor Status

Immunohistochemical estrogen receptor (ER) status observation with expression level and percentage in tumor cell nuclei.

Observation: HER2 FISH/CISH/SISH Molecular Test

HER2 gene amplification molecular test observation (FISH, CISH, or SISH) with numeric HER2 average, CEP17 average, HER2/CEP17 ratio, and result classification.

Observation: Ki-67 Proliferation Index

Ki-67 proliferation index observation expressed as a percentage of tumor cells with positive nuclear staining.

Observation: Progesterone Receptor Status

Immunohistochemical progesterone receptor (PR) status observation with expression level and percentage in tumor cell nuclei.

Structures: Extension Definitions

These define constraints on FHIR data types for systems conforming to this implementation guide.

Specimen reciever

Ėminį priėmęs specialistas. / Whoever has received the specimen.

Terminology: Value Sets

These define sets of codes used by systems conforming to this implementation guide.

Cervical Tumor Stage pN

Pathological regional lymph node (pN) staging for cervical cancer, AJCC 8th edition.

Cervical Tumor Stage pT

Pathological primary tumor (pT) staging for cervical cancer, AJCC 8th edition. Includes pTX through pT4.

HER2 FISH/CISH/SISH Result Classification (VS)

Classification of HER2 gene amplification results.

HER2 IHC Score (VS)

HER2 immunohistochemical scoring system (0+ to 3+).

Her2 Receptor Statuses

The data item records the Her2 (human epidermal growth factor receptor 2) expression status of the tumour.

Histological Grading

Histological grade of tumor differentiation according to AJCC grading system.

ICD-O-3 Morphology

Cancer morphology

IHC Expression Level (VS)

Immunohistochemical expression level for receptor status (negative, weak, moderate, strong).

Lymphovascular Invasion

Microscopic finding of lymphatic and/or vascular tumor invasion.

Pathology Service Code

Codes for pathology services.

Perineural Invasion

Microscopic finding of perineural invasion by tumor.

Periprostatic Fat Invasion

Microscopic finding of tumor infiltration in periprostatic adipose tissue.

Prostate Tumor Stage M

Codes for prostate tumor stages M.

Prostate Tumor Stage N

Codes for prostate tumor stages N.

Prostate Tumor Stage T

Codes for prostate tumor stages T.

Sample Examination Methods

Microscopic or Microscopic examinations of the specimen.

Seminal Vesicle Invasion

Microscopic finding of tumor infiltration in seminal vesicles or ejaculatory duct.

Specimen Additive

Additives used in specimen collection and processing, based on HL7 EU Laboratory specimen additive ValueSet with additional codes for Lithuanian use.

Specimen Adequacy Code

Codes for specimen adequacy.

Tumor Focality

Codes for tumor focality.

Tumor Type

ValueSet for tumor types, coded from SNOMED CT.

Tumor Volume Methodology

Methodology used for determining tumor volume in biopsy specimens.

pLVI Classification (VS)

Peritumoral lymphovascular invasion (pLVI) 6-level classification.

Terminology: Code Systems

These define new code systems used by systems conforming to this implementation guide.

HER2 FISH/CISH/SISH Result Classification

Classification of HER2 gene amplification results from FISH, CISH, or SISH molecular testing.

HER2 IHC Score

HER2 immunohistochemical scoring system (0+ to 3+).

Her2 Receptor Status

The data item records the Her2 (human epidermal growth factor receptor 2) expression status of the tumour.

IHC Expression Level

Immunohistochemical expression level classification for receptor status assessment.

Lithuanian UCUM localisation

Localized Lithuanian UCUM units described as display designation and alternative code as synonym

Tumor Observable Component Codes (LT Lab)

Local codes for TumorObservableLtLab component slicing. Used until equivalent SNOMED CT observable entity codes are available.

pLVI Classification

Peritumoral lymphovascular invasion (pLVI) 6-level classification for breast cancer pathology.

Example: Example Instances

These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.

Composition: Pathology Document (example)

Synoptic pathology composition conforming to PathologyCompositionLtLab: Pre-Analytic, Macro, Micro, and Synthesis (LOINC section codes). Entries reference breast histopathology examples for the main pathway; synthesis also references an example prostate cancer Condition to illustrate TNM and morphology staging in this guide.

Condition: Prostate Cancer (example)

Example of pathological T category with clinical N and M categories and ICD-O-3 morphology, for use alongside synoptic pathology reporting.

DiagnosticReport: Pathology Report (example)
Observation: ACR (example)

Example observation of a patient's urine albumin-to-creatinine ratio.

Observation: Cholesterol HDL (example)

Example observation showing a patient's HDL cholesterol level within normal range.

Observation: Cholesterol LDL (example)

Example observation showing a patient's calculated LDL cholesterol level.

Observation: Cholesterol Non-HDL (example)

Example observation showing a patient's non-HDL cholesterol level within normal range.

Observation: Creatinine Test (example)

Example observation of serum creatinine concentration.

Observation: Estrogen Receptor Status (example)
Observation: Glucose Venous (example)

Example of laboratory glucose measurement in venous blood.

Observation: Gram Stain (example)
Observation: HER2 FISH Molecular Test (example)
Observation: HbA1c (example)

Example of HbA1c test result for a patient with moderately elevated glycemia.

Observation: Her2 Receptor Status (example)
Observation: Ki-67 Proliferation Index (example)
Observation: Lipidogram (example)

Example lipid panel with high LDL and normal HDL.

Observation: Progesterone Receptor Status (example)
Observation: Prostate PSA (example)

Prostate Specific Antigen (PSA) Observation Example

Observation: Prostate PSA Density (example)

Prostate-Specific Antigen Density (PSAD) Observation Example

Observation: Prostate Volume (example)

Prostate Volume Observation Example

Observation: Specimen Adequacy (example)
Observation: Specimen Measurement (example)

An example instance of the Specimen Measurement observation.

Observation: Total Cholesterol (example)

Example observation showing a patient's total cholesterol level within normal range.

Observation: Triglycerides (example)

Example observation showing a patient's triglyceride level within normal range.

Observation: Tumor Measurement (example)

An example instance of the Tumor Measurement observation.

Observation: Tumor Observable (example)
Observation: eGFR (example)

Example showing a patient's eGFR result calculated using the CKD-EPI 2021 formula.

Organization: Vilnius Heart Clinic (example)
Patient: Jonas Petrauskas (example)

An example Patient conforming to the Lithuanian Base Profile.

Practitioner: Registrar (example)
Procedure: Breast Biopsy (example)

Example of a breast biopsy procedure performed for histopathology.

Procedure: Histology (example)

Example of a histology procedure performed during pathology evaluation.

ServiceRequest: Pathology Order (example)

Example of the pathology order.

ServiceRequest: Pathology Order — Prostate (example)

Example pathology order for prostate-related examination using a PathologyProcedure code (prostate neoplasm screening).

Specimen Block: #A1 from Left Breast (example)
Specimen: Left Breast Tissue (example)
Specimen: Right Breast Tissue (example)
Specimen: Venous Blood (example)

Venous blood sample used for glucose testing.

Substance: Neutral Buffered Formalin (example)