LOINC Laboratory Committee meeting

�March 19th,, 2026

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Agenda

SHIELD Update�by�Andrea Pitkus

SHIELD Home Page URL here https://aphlinformatics.atlassian.net/wiki/spaces/SC/overview?homepageId=986579060

DRUG/TOX Heuristics

Member of Drug/Tox class & in drugs of abuse

Status=Active

Any specimen type

Only those analytes for which there are screen/confirm in methods currently

Include: xyz positive, xyz present, xyz tested for

Exclude: Cutoffs

ACTIONS on Observations

Discourage codes with screen/confirm in method

Create new codes IA, Mass Spec for each relevant specimen/property

Include cutoff in the method

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Analytes normalized to creatinine, only a single methodless code

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DRUG/TOX Development Progress

• First pass with MS Co-Pilot was incomplete
• PBanning took on manual effort – 9%
• SWagers will break up remaining evaluation between February & March after LOINC release (1240 components/specimens)

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Drug/Tox – verified analyte accuracy

93474-5�

Are the class members and metabolites qualified?

Drug/Tox – short name comparison?

Source: Canada Health Infoway

Intro to Catecholamines

Eza requested the next meeting include a discussion about catecholamines (free vs total/unfractionated, fractionated reporting, urine vs serum) because coding is currently ambiguous in LOINC, and this causes confusion.

Stan explained ambiguity 1/29/26: some LOINC entries say “catecholamines” without clarifying whether they mean total (sum) or fractionated (separate components like epinephrine, norepinephrine, dopamine). There is no distinct code for catecholamine.total in some cases.

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Key Differences: Fractionated vs. Total Catecholamines�

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Fractionated Catecholamines: Measure individual active hormones—norepinephrine, epinephrine, and dopamine—separately in blood or urine. This is used to diagnose tumors that release these compounds episodically.

Total Catecholamines: A combined, less common measurement of all catecholamines.

Metanephrines (Fractionated): The preferred, more sensitive alternative. These are the O-methylated metabolites (breakdown products) of catecholamines (metanephrine and normetanephrine). Because pheochromocytomas metabolize catecholamines internally into metanephrines before releasing them, measuring metanephrines (especially in plasma) is far superior to measuring the catecholamines themselves. 

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Metrics for mining in LOINC 2.81

Class: Chem only

Omit Coag, Chal and LabOrders.Ontology from this pass

Status: Active, Discouraged

Scale: Qn

Keywords: catecholamine(s), metanephrine(s), epinephrine, norepinephrine, dopamine, vanillylmandelate, homovanillate, normetanephrine

Definitions from LOINC Parts

Ser/Plas Metrics

Urine Metrics

Considerations for Confusion? IMP property

Considerations for Confusion? Timing

Considerations for Confusion? Ord Scale

Catecholamines

Catecholamines

Catecholamines in LOINC

1- Fractionated and/or Fractionated .free should be panel

2- Catecholamines or Catecholamines.free mean:

- Panel, or

- Total Catecholamimes

Top 2000 Catecholamines

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- 44838-1 High usage, fine

- 2056-0 (Rank=704): is it a panel or a Total?

- 2058-6 (Rank= 489): Is this a panel or a Total?

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Total Catecholamines is never reported in Plasma, we can add one…

- 30486-5 Challenge test

Patient Generated Health Data

• Committee, LOINC Chairs and SHIELD all agreed to watch PGHD
• Two avenues – physical metrics vs smartphone-based observations

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Key examples of Smartphone-based Labs:

Anemia Detection (Hemoglobin): A smartphone application analyzes images of a user's finger placed over the camera flash to calculate hemoglobin levels, allowing for remote monitoring of anemia without laboratory blood draws.

Infectious Disease Testing (HIV/Syphilis/COVID-19): Microfluidic diagnostic platforms connect to smartphones to detect HIV and syphilis antibodies from a finger-prick sample. Another example is a smartphone-based kit for detecting COVID-19 and its viral load.

HbA1c Monitoring for Diabetes: A smartphone-based device tested in Indonesia measured HbA1c levels, offering an accurate, low-cost option for diabetes management in primary healthcare settings.

Fertility/Semen Analysis: A smartphone-based analyzer uses microscopy to measure sperm concentration and motility, with performance comparable to conventional laboratory tests.

Real-time Pathogen Detection: Smartphones can be used for rapid, point-of-care detection of pathogens such as Salmonella and E. coli using specialized biosensors.

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Imaging and Colorimetric Analysis

Urinalysis via Camera: Patients can use apps like StripTest or Scanwell Health to take photos of urine test strips. The app analyzes color changes in the reagent pads to detect leukocytes, nitrites, protein, and pH levels, then sends results directly to a physician.

Anemia Screening (Fingernail Bed Analysis): Apps have been developed to estimate hemoglobin levels by analyzing the color of a patient's fingernail bed from a smartphone photo. This provides a non-invasive alternative to traditional blood-based laboratory tests.

Chronic Disease Monitoring (Crohn's Disease): Patients use the Novarum platform to monitor specific biomarkers at home. The app reads diagnostic tests that detect increases in concentration months before a flare-up, allowing for preemptive treatment adjustments. 

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Plug-in Hardware and External Sensors

Portable Smartphone Labs: Engineers have created credit-card-sized labs that plug into a phone's charging port or audio jack. Patients place a saliva or blood sample on a disposable chip, and the smartphone processes the data to diagnose conditions like malaria, HIV, Lyme disease, or coronavirus.

Blood Clotting Time (PT/INR): Researchers at the University of Washington developed a system that uses the phone's vibration motor and camera to measure blood clotting speed. A patient adds a drop of blood to a small cup attached to the phone; the phone shakes the cup and uses the camera to monitor when a particle stops moving as the clot forms.

Fertility Testing: Automated assays use a smartphone-based attachment to analyze a small semen sample (<35 μl) for sperm concentration and motility. The results are comparable to high-end laboratory-based Computer-Aided Sperm Analysis (CASA) platforms. 

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Mobile Microscopic Attachments

Parasite Detection: Smartphone-based microscopes can detect parasites like Loa loa (African eye worm) or Schistosoma eggs in blood or urine samples. These devices use video microscopy and automated algorithms to identify motion or specific morphological features of parasites.

Blood Cell Counting: Low-cost attachments called "μ-phones" allow patients to capture microscopic images of blood samples. The smartphone processes these images in seconds to provide red and white blood cell counts, which can then be transmitted to healthcare providers. 

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Finding FDA documents

FDA assigns “Product Codes” to groups/similar devices

- JRT – for clinical urine chemistry (used by apps that read urine strips)

- PIW – for smartphone-based automated sperm analyzers

Click on Device Identifier (DI), look for prefixes K (510k), P (PMA), DEN (De Novo)

Take that number to the FDA’s IVD Database to learn of validation method

2026 CPT Billing Codes for PGHD

Integrating this data into Clinical Workflows

The Agency for Healthcare Research and Quality (AHRQ) has published a comprehensive, six-folio guide specifically for ambulatory care settings.

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The Office of the National Coordinator (ONC) defines a "Loop" workflow that is now widely adopted in 2026.

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Research published in PMC (PubMed Central) by the NCCN EHR Oncology Advisory Group demonstrates a mature workflow for symptom monitoring:

Staging vs. Embedding: 90% of centers now embed at least some PGHD directly into the patient's record rather than keeping it in a separate portal.   

Role-Based Access: Workflows now define who sees what. For instance, medical assistants might screen for compliance (did the patient take the test?), while physicians only receive notifications for out-of-range biomarkers.

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Discussion

• Has the case been made that PGHD would be covered by LOINC?
• If not, what else is needed?

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• Other points?

Lab Orders Working Group Update

• Composition: Reference Labs, Public Health, Compliance
• Remaining (?) state registries / agencies
• Draft state
• Provide guidance for LabOrders.Ontology
• Kb sections
• Decision mapping tree for Orders by use case
• Pushing back estimated delivery of action item to April/May 2026
• KB Section 13 – Orderable Grouper Concepts

Working Group Representation (now 18)

Discussions included

1. Differences of the word Observations; Order; multiple things in msg
2. Have online searches first filter by all Order or all Result
3. Have the LOINC name INCLUDE “Order” or “Result”
4. There’s not clinical entity behind orders
5. Builders are NOT clinicians
6. Caveat different use cases and state when to use

Announcements

LOINC Conference: October 6-9

• Global Data, Local Care: Advancing Smarter Standards
• Call for presentation proposals open, submit by April 4, 2026

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Announcements

Civitas Tech Informatics Workgroup Intro to LOINC held March 17^th

LOINC webinar held March 13^th – Next community webinar Summer 2026

Closing

2026 meeting calendar

• JAN 15
• FEB 19
• MAR 19
• APR 16 ⬅️
• MAY 21
• JUN 18
• JUL – no meeting, summer hiatus
• AUG – no meeting, LOINC release
• SEP 17
• OCT 15
• NOV 19
• DEC 17

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Closing

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Next Meeting: April 16^th 9:00 am Eastern

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