D1 — Process Intelligence Brief
Five governance gaps at a large NCI-Designated Comprehensive Cancer Center with 677 licensed beds and 145,000+ patients annually. Three of the five gaps carry the highest possible priority rating. This brief is PDIO Deliverable 1 of 4.
Executive Summary
This brief addresses five governance gaps at Regional Medical Center. Three of the five gaps carry the highest possible priority rating.
The most urgent gap is chemotherapy dosing governance. Between 3% and 5% of patients carry DPYD variants that make standard fluorouracil dosing potentially lethal. Today, those genetic test results sit in the lab section of the EHR and are not flagged at the point of prescribing. A pharmacist may catch it on manual review — or may not. A single missed variant costs $500,000+ in care, litigation, and CMS quality reporting impact.
The second critical gap is treatment eligibility governance. Molecular pathology results arrive as PDF reports and are reviewed manually in tumor board. No automated cross-reference exists between a patient's tumor mutation panel (KRAS, EGFR, BRCA1/2, HER2) and the drug eligibility rules. A wrong treatment line costs $200,000+ in drug costs, lost treatment windows, and secondary adverse events.
The third critical gap is immunocompromised patient environment governance. Neutropenic patients (ANC < 500) require positive-pressure clean rooms with HEPA filtration. Today, room checks are scheduled — not triggered by real-time correlation between the patient's ANC lab values and the room's environmental conditions. A pathogen exposure during neutropenic nadir costs $50,000–$150,000 per sepsis event plus CMS HAI penalties.
Process Inventory
Each process below involves decisions currently made without a governed record of who decided what, when, on what basis, and with what confidence. The gap is not that decisions are wrong — it is that no one can prove they were right.
Chemotherapy Dosing Governance
Clinical
Per treatment cycle
Attending Oncologist
No automated PGx cross-reference at point of ordering. Genetic test results sit in lab section, not flagged at prescribing.
Immunocompromised Patient Environment
Safety
Continuous during neutropenic episodes
Infection Preventionist
No real-time correlation between ANC lab values and environmental conditions. Room checks are scheduled, not triggered by patient status.
Treatment Eligibility Governance
Clinical
Per treatment decision
Tumor Board / Attending Oncologist
Molecular pathology results are PDFs, not structured data. No automated cross-reference between tumor profile and drug eligibility.
Wildfire Smoke Response
Safety
Event-driven (wildfire season)
Facility Engineering
No automated correlation between NASA FIRMS data, EPA AQI, and HVAC recirculation protocols.
Hereditary Cancer Screening Governance
Clinical
Per patient + annual
Genetic Counselor / Oncology Navigator
Genetic counseling results not systematically connected to screening protocol assignments. Patients fall through cracks at care transitions.
Decision Flow — Current State
Chemotherapy Dosing
The attending oncologist writes the chemotherapy order. If a DPYD genotype test was ordered (not always), the result lives in the lab section of the EHR. The pharmacist may review it during order verification — but the review is manual and the PGx result is not surfaced in the prescribing workflow. If the pharmacist is busy, covering multiple units, or the test was ordered by a different provider, the result can be missed entirely. There is no system flag that says "this patient has a DPYD variant — do not administer standard-dose 5-FU." The trail breaks at the gap between the lab result and the prescribing decision.
Immunocompromised Environment
The infection preventionist monitors neutropenic patients and coordinates with facility engineering on clean room requirements. ANC lab values arrive in the EHR. Clean room environmental data (differential pressure, HEPA status, air exchanges) lives in the Building Management System. These two systems do not talk to each other. When a patient's ANC drops below 500, the room should shift to positive pressure with restricted access — but that shift depends on a human reading the lab, recognizing the threshold, and calling engineering. At night, on weekends, or during high census, this handoff fails.
Treatment Eligibility
The tumor board reviews molecular pathology reports — typically multi-page PDFs from the molecular lab. A pathologist presents the findings verbally. The attending oncologist maps the mutations to treatment eligibility (KRAS wild-type → cetuximab eligible; EGFR mutant → TKI eligible; BRCA1/2 pathogenic → PARP inhibitor eligible). This mapping is done from memory or reference materials. There is no structured cross-reference between the patient's specific variant profile and the current drug eligibility database (ClinVar, COSMIC). Mismatches are caught only if someone in the room remembers the contraindication.
Signal Environment — 10 Active Signals
Environmental Signals
| Signal ID | Signal | Source | Sampling | Normal | Warning | Critical | Process |
|---|---|---|---|---|---|---|---|
| CC-004 | Clean Room Differential Pressure | BMS pressure sensor | Continuous | ≥2.5 Pa | 1.0–2.5 Pa | <1.0 Pa or negative | PROC-002 |
| CC-005 | Indoor PM2.5 (Oncology Unit) | Laser scattering sensor | Every 5 min | 0–12 μg/m³ | 12.1–35.4 | 35.5+ | PROC-004 |
Human Health Signals
| Signal ID | Signal | Source | Sampling | Normal | Warning | Critical | Process |
|---|---|---|---|---|---|---|---|
| CC-001 | Absolute Neutrophil Count (ANC) | EHR FHIR (DiagnosticReport) | Per lab draw | 1,500–8,000 cells/μL | 500–1,000 (neutropenic) | <500 (severe neutropenia) | PROC-002 |
External Intelligence Signals
| Signal ID | Signal | Source | Sampling | Normal | Warning | Critical | Process |
|---|---|---|---|---|---|---|---|
| CC-006 | Outdoor AQI | EPA AirNow API | Hourly | 0–50 (Good) | 101–150 (Sensitive Groups) | 201+ (Very Unhealthy) | PROC-004 |
| CC-007 | UV Index | EPA/NWS UV Index API | Daily forecast | 0–2 (Low) | 6–7 (High) | 8+ (Very High) | PROC-001 |
| CC-008 | Respiratory Virus Activity | CDC Wastewater Surveillance | Weekly | Very Low (<2.5) | Moderate (5.2–8.0) | High (>11.0) | PROC-002 |
| CC-010 | CMS HAI Benchmark | CMS Provider Data (NHSN) | Quarterly | SIR <1.0 | SIR 1.0–1.5 | SIR >1.5 | All |
Genomics / Pharmacogenomics Signals
| Signal ID | Signal | Source | Sampling | Normal | Warning | Critical | Process |
|---|---|---|---|---|---|---|---|
| CC-002 | DPYD Genotype | Molecular Lab + CPIC API | Once (germline) | Normal metabolizer (*1/*1) | Intermediate (1/2) | Poor metabolizer (2A/2A, 13) | PROC-001 |
| CC-003 | Tumor Mutation Panel | Molecular Pathology + ClinVar | Once per specimen | N/A | Actionable mutation detected | Contraindicated therapy match | PROC-003 |
| CC-009 | BRCA1/2 Germline Status | Molecular Lab + ClinVar + gnomAD | Once (germline) | Wild type | VUS | Pathogenic / Likely Pathogenic | PROC-005 |
Decision Authority Map
| Role | Decision Scope | Response Window | Escalation Path |
|---|---|---|---|
| Attending Oncologist | Chemotherapy dosing, treatment selection | Immediate (point of care) | Department Chair → Chief Medical Officer |
| Infection Preventionist | Environmental governance, PPE/visitor policy | Within 1 hour of trigger | Hospital Epidemiologist → Chief Operating Officer |
| Tumor Board (Committee) | Treatment eligibility for complex cases | Weekly meeting | Chief Medical Officer |
| Facility Engineering | HVAC, pressure, air exchange adjustments | Within 30 minutes of trigger | Director of Facilities → Chief Operating Officer |
| Genetic Counselor | Screening protocol assignment, hereditary risk | Per appointment (scheduled) | Oncology Navigator → Department Chair |
| Pharmacist | Order verification, drug interaction check | Per order (queue-based) | Pharmacy Director → Chief Medical Officer |
Gap 1: No designated authority for PGx integration at prescribing.
The oncologist writes the order. The pharmacist verifies. The lab holds the PGx result. No one owns the step that says 'before this order is filled, confirm the patient's DPYD status.' This is a gap between three roles, not a gap in any single role.
Gap 2: No real-time environmental decision authority.
When a patient's ANC drops at 2 AM and the room needs to shift to positive pressure, who makes that call? The night-shift charge nurse? The on-call infection preventionist? The answer varies by shift, by unit, and by who is available. There is no standing protocol that says 'ANC < 500 → automatic environmental governance trigger.'
Gap 3: Tumor board authority is time-limited.
The tumor board meets weekly. Treatment decisions between meetings default to the attending oncologist, who may or may not have the molecular pathology results in structured form. Urgent cases cannot wait for the next meeting.
ERI / LPRM Configuration Recommendations
Environmental Risk Index (ERI) — Facility-Level
Primary barrier against pathogen infiltration in neutropenic rooms. Negative pressure = immediate safety event.
Immunocompromised patients at 10x risk. Must correlate with outdoor AQI and wildfire data.
Leading indicator for HVAC load. Recurring refinery and wildfire exposure creates recurring spikes.
Quarterly penalty exposure metric. SIR >1.5 = bottom quartile = 1% Medicare reduction.
VOC, CO₂, humidity, C. diff UV-C — available after sensor deployment.
Living Patient Risk Model (LPRM) — Patient-Level
Primary trigger for environmental governance. ANC <500 = febrile neutropenia risk.
Leading indicator for PPE/visitor policy changes in immunocompromised population.
Photosensitive chemo drugs (methotrexate, 5-FU, doxorubicin). Relevant for ambulatory patients.
Not weighted — this is a pass/fail gate. Poor metabolizer = 50% dose reduction, no exceptions.
Not weighted — maps to treatment eligibility rules, not a continuous index.
Continuous vitals, wearable biomarkers, real-time EHR trending.
Threshold Recommendations
| Metric | Warning Threshold | Critical Threshold | Basis |
|---|---|---|---|
| ERI Warning | 0.45 | — | Sum of weighted environmental signals indicates moderate facility risk. |
| ERI Critical | — | 0.70 | Immediate environmental governance required. Authority notified. |
| LPRM Warning | 0.40 | — | Patient-level risk indicates heightened monitoring. |
| LPRM Critical | — | 0.65 | Immediate clinical governance required. Authority escalation. |
| Confidence Escalation | — | <0.70 | Below this threshold, ATLAS escalates to the designated human authority rather than delivering an automated recommendation. |
Cost of Inaction
| Risk | Annual Exposure | Basis |
|---|---|---|
| DPYD adverse event (1 per year, conservative) | $500,000+ | Single Grade 4+ fluorouracil toxicity: ICU stay ($150K–$300K), litigation exposure ($200K–$500K), CMS quality reporting impact. Source: FDA Safety Communication 2020; ADE litigation benchmarks. |
| Wrong treatment line (2 per year, conservative) | $400,000+ | Drug costs ($120K/year), lost treatment window (non-recoverable), secondary adverse events. Source: ASCO treatment cost data 2024. |
| Neutropenic sepsis from environmental failure (2 per year) | $100,000–$300,000 | Extended stay ($50K–$150K per event), CMS HAI penalty (1% Medicare reduction for bottom quartile). Source: CMS HAI Program; HHS AHRQ data. |
| Wildfire smoke respiratory event (1 per year) | $25,000–$75,000 | Respiratory admission for immunocompromised patient during AQI spike. Source: EPA ISA 2019. |
| Hereditary screening gap (delayed diagnoses) | $100,000+ | Late-stage vs. early-stage treatment cost differential. Source: NCI SEER Program. |
Total estimated annual exposure: $1,125,000 – $1,375,000+
This is not the cost of ATLAS. This is the cost of continuing without governed decision intelligence.
Governance Receipt Requirement
For this engagement, governance receipts will be generated for each decision triggered by the configured governance rules. Each receipt contains:
Next Steps
- Client reviews D1 and confirms or corrects the process inventory, authority structure, and risk assessment. Specific attention to: authority gap assignments, actual incident rates (if available), and any processes not captured in the intake.
- Upon D1 approval → Cromtec proceeds to D2 (Governance Design Specification). D2 will specify exact governance rules, signal configurations, decision routing, escalation protocols, and receipt specifications — ready for engineering implementation.
- D2 delivery timeline: 10 business days from D1 approval. D2 is the technical blueprint — it defines what gets built.
Anonymized · Real Engagement · CROMTEC.AI · Patent TPP96862
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