name: loinc-hsc-panel
description: >
Use correct LOINC codes for HSC (Hematopoietic Stem Cell) product lab orders, result validation,
and test panel configuration per FDA 21 CFR 1271.85 and FACT-JACIE standards. Trigger whenever
the user works on lab order generation (ORM^O01), lab result validation, clinical config for test
panels, LOINC code references in HL7 messages (OBR-4, OBX-3), CD34 counts, infectious disease
screening, donor testing, ABO/Rh typing, cell viability, sterility cultures, or any code mentioning
"LOINC", "lab panel", "test codes", "donor eligibility", or "HCT/P testing".

LOINC HSC Panel Skill

Provides verified LOINC codes for HSC product testing per FDA 21 CFR 1271.85 and ICCBBA/FACT standards.

HSC Product Test Panel — Complete LOINC Code Table

Cell Characterization (Product Quality)

ABO/Rh Typing

Infectious Disease Screening (FDA 21 CFR 1271.85)

Sterility / Microbiology

All Valid LOINC Codes (Lookup Set)

Use this set to validate that a LOINC code is a recognized HSC panel code:

VALID_HSC_LOINC_CODES = {
    # Cell characterization
    "42808-4", "8125-7", "80698-4", "26464-8", "26515-7", "718-7", "55793-4", "34542-1",
    # ABO/Rh
    "882-1", "10331-7", "34532-2",
    # Infectious disease
    "62469-2", "68961-2", "29893-5", "30361-0", "5196-1",
    "5195-3", "16933-4", "42595-7",
    "16128-1", "7905-3",
    "22587-0", "20507-0",
    "22244-8", "5124-3",
    "7942-6",
    # Sterility
    "630-4", "635-3", "580-1",
}

Recommended Minimum Default Panel

For an HSC product, the minimum panel that satisfies FDA 21 CFR 1271.85 + FACT standards:

DEFAULT_HSC_PANEL = [
    # Product characterization
    {"code": "42808-4", "name": "CD34 cells [#/volume] in Blood"},
    {"code": "8125-7",  "name": "CD34 cells/100 cells in Blood"},
    {"code": "26464-8", "name": "Leukocytes [#/volume] in Blood"},
    {"code": "34542-1", "name": "Cell viability [%] in Body fluid"},
    # ABO/Rh
    {"code": "882-1",   "name": "ABO group [Type] in Blood"},
    {"code": "10331-7", "name": "Rh [Type] in Blood"},
    # Infectious disease (FDA-mandated)
    {"code": "62469-2", "name": "HIV 1+2 Ab+Ag [Presence] in Serum or Plasma"},
    {"code": "5195-3",  "name": "HBsAg [Presence] in Serum"},
    {"code": "16933-4", "name": "HBc Ab [Presence] in Serum"},
    {"code": "16128-1", "name": "HCV Ab [Presence] in Serum"},
    {"code": "22587-0", "name": "Treponema pallidum Ab [Presence] in Serum"},
    {"code": "22244-8", "name": "CMV IgG Ab [Mass/volume] in Serum"},
    {"code": "5124-3",  "name": "CMV IgM Ab [Presence] in Serum"},
    {"code": "7942-6",  "name": "HTLV I+II Ab [Presence] in Serum"},
    # Sterility
    {"code": "630-4",   "name": "Bacteria identified in Blood by Culture"},
]

This is 15 tests. The absolute minimum for FDA compliance is the 8 infectious disease codes + CD34 + viability = 10.

Reference Ranges

These are typical ranges. Actual ranges MUST be configured per-institution via clinical config with dual sign-off.

HL7 Encoding

OBR-4 (Universal Service Identifier)

OBR|1|ORD12345||42808-4^CD34 cells [#/volume] in Blood^LN|||...

Format: LOINC_CODE^LOINC_LONG_NAME^LN

The third component MUST be LN (LOINC coding system identifier per HL7 Table 0396).

OBX-3 (Observation Identifier)

OBX|1|NM|42808-4^CD34 cells^LN||250|cells/uL||N|||F

Multiple Tests in One ORM^O01

Each LOINC code gets its own ORC+OBR group:

ORC|NW|ORD001|||...
OBR|1|ORD001||42808-4^CD34 cells^LN|||...
ORC|NW|ORD002|||...
OBR|2|ORD002||882-1^ABO group^LN|||...

Critical Bug: 58410-2 is NOT CD34

The code 58410-2 is "CBC panel - Blood by Automated count" — a complete blood count panel, not a CD34 count.

If you see 58410-2 labeled as "CD34+ count" anywhere in the codebase, it's a bug.

FDA Regulatory Context

21 CFR 1271.85 — Donor Testing Requirements

ALL HCT/P donors (including HSC) must be tested for:
- HIV-1 (antibody + NAT)
- HIV-2 (antibody; combo test acceptable)
- HBV (HBsAg + anti-HBc + NAT)
- HCV (antibody + NAT)
- Syphilis (T. pallidum — treponemal or non-treponemal)

Viable leukocyte-rich HCT/Ps (HSC products qualify) additionally require:
- CMV (IgG and IgM antibodies)
- HTLV-I/II (antibody)

A positive CMV does NOT make the donor ineligible — it must be communicated to the accepting physician.

FACT-JACIE Standards

• All products must have ABO/Rh typing
• Cell characterization (CD34, TNC, viability) required for product release
• Sterility testing required for processed products

Known Bugs in Current Project Code

Bug 1: Wrong LOINC for CD34

File: src/agents/orchestration/nodes/order.py (line ~49)

# CURRENT (wrong):
loinc_codes = [
    {"code": "58410-2", "name": "CD34+ count"},    # WRONG! This is CBC panel
    {"code": "26515-7", "name": "Platelet count"},
]

# CORRECT:
loinc_codes = [
    {"code": "42808-4", "name": "CD34 cells [#/volume] in Blood"},
    {"code": "26515-7", "name": "Platelets [#/volume] in Blood"},
]

Bug 2: Default panel has only 2 tests

An HSC product requires minimum 10-15 tests (cell characterization + ABO/Rh + infectious disease + sterility). The default fallback should use DEFAULT_HSC_PANEL (15 tests) defined above.

Bug 3: No LOINC validation

File: src/services/config_service.py

The config service accepts arbitrary strings as LOINC codes without checking if they're valid. Should validate against VALID_HSC_LOINC_CODES.

Quick Reference Card

Reference Files

• references/loinc_codes.md — Full LOINC code table with all fields
• references/fda_requirements.md — FDA 21 CFR 1271.85 donor testing details
• references/known_bugs.md — Current codebase bugs with fix patches