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Policies

8 governance policies that constrain entity operations, workflow execution, and business rules across the healthcare ontology. Each policy is defined in enterprise-knowledge/policies/ as a Markdown file.


Policy Summary

# Policy ID Regulatory Risk Owner Constrains
1 Clinical Safety Policy POL-CLIN-001 FHIR / TJC Critical CMO (Chief Medical Officer) Medication_Order, Clinical_Order, Lab_Result, Drug_Interaction
2 HIPAA Privacy & Security Policy POL-HIPAA-001 HIPAA Critical Privacy Officer / CISO PHI_Access_Log, Patient_Consent, Patient_Master
3 Revenue Cycle Policy POL-REV-001 CMS / CPT High CFO / Revenue Cycle Director Claim, Denial, Charge, Prior_Authorization
4 Bed Management & Capacity Policy POL-BED-001 CMS CoP High COO / VP Operations Bed_Census, OR_Schedule, ED_Arrival, Staffing
5 Quality Measure Policy POL-QUAL-001 CMS / TJC / HEDIS High CMO / Chief Quality Officer Quality_Measure, Adverse_Event, Infection_Indicator, Safety_Assessment
6 Pharmacy & Formulary Policy POL-PHARM-001 FDA / P&T High Chief Pharmacy Officer Medication_Order, Pharmacy_Inventory, Controlled_Substance_Log, Supply_Inventory
7 Data Freshness Policy POL-DATA-001 FHIR / Interop Medium CMIO / Chief Data Officer All integration feeds
8 Regulatory Reporting Policy POL-REG-001 CMS / State / TJC High Chief Compliance Officer Regulatory_Return, Accreditation_Standard, Regulatory_Publication

1. Clinical Safety Policy

ID: POL-CLIN-001 | Regulatory: FHIR / TJC | Systems: EHR, CPOE, LIS

Rule Area Key Rules
Medication Safety High-severity drug interactions trigger interruptive hard stop; override requires attending physician justification documented in order
Critical Lab Acknowledgment Critical lab result acknowledgment SLA: 15 min to ordering provider; 30 min escalation to covering physician and department head
Sepsis Bundle Compliance Sepsis bundle compliance target >85%; non-compliance triggers real-time nursing and physician alert with escalation to charge nurse
Clinical Pathway Adherence Clinical pathway adherence target >80%; variance documentation required for deviations; quarterly pathway review by clinical governance
Duplicate Order Prevention Duplicate orders within active timeframe blocked with override requiring clinical justification; applies to labs, imaging, and medications
Weight-Based Dosing Weight-based dosing verification mandatory for pediatric patients and renal-adjusted patients; dose outside calculated range requires pharmacist sign-off

2. HIPAA Privacy & Security Policy

ID: POL-HIPAA-001 | Regulatory: HIPAA | Systems: EHR, IAM, Audit

Rule Area Key Rules
Minimum Necessary Access Access to PHI restricted to minimum necessary for job function; role definitions reviewed semi-annually by Privacy Officer
Role-Based PHI Access PHI access granted by role assignment; cross-department access requires supervisor approval; VIP/restricted patient records require explicit authorization
Break-the-Glass Audit Break-the-glass override triggers immediate audit log entry; >3 uses by same user in 30 days triggers formal investigation by Privacy Officer
Access Anomaly Detection Automated detection of unusual access patterns (after-hours, volume spikes, accessing records outside care team); anomalies flagged for review within 24 hours
Breach Notification Breach notification within 60 days for incidents affecting >500 individuals; immediate notification to HHS and affected individuals per HIPAA Breach Notification Rule
PHI Log Retention PHI access log retention: 6 years minimum; logs must be tamper-evident and available for audit within 48 hours of request
De-Identification De-identification per Safe Harbor (18 identifiers removed) or Expert Determination method; re-identification risk assessment required for limited datasets
Consent Management Consent management for research data sharing and HIE participation; patient opt-in/opt-out tracked; consent expiration and renewal enforced

3. Revenue Cycle Policy

ID: POL-REV-001 | Regulatory: CMS / CPT | Systems: PAS, Billing, Claims

Rule Area Key Rules
Clean Claim Rate Clean claim rate target >95%; claims failing front-end edits returned to coding within 24 hours; root cause analysis for rates below 90%
Denial Rework SLA High-value denials (>$5K): rework within 48 hours; standard denials: rework within 5 business days; aging denials >30 days escalated to Revenue Cycle Director
Timely Filing 100% compliance with payer-specific filing deadlines; automated alerts at 75% and 90% of deadline elapsed; missed deadlines tracked as revenue leakage
Coding Accuracy Coding accuracy target >97%; quarterly audit of random sample (minimum 5% of encounters); discrepancies >3% trigger coder re-education
Charge Capture Charge capture reconciliation within 3 business days of service date; missing charges identified by comparing scheduled procedures to posted charges
Underpayment Follow-Up Underpayment follow-up initiated for variance >5% from contracted rate; appeals filed within payer-specific appeal window; trends reported monthly to CFO
Prior Authorization Prior authorization submission within 24 hours of scheduling; status tracked through determination; expired auths flagged before service date

4. Bed Management & Capacity Policy

ID: POL-BED-001 | Regulatory: CMS CoP | Systems: ADT, ED, OR Scheduling, Staffing

Rule Area Key Rules
ED Boarding ED boarding maximum 4 hours; escalation to house supervisor at 2 hours; >4 hours triggers capacity alert to COO and activates surge discharge protocol
Bed Occupancy Optimal bed occupancy range 82-88%; below 80%: review elective scheduling capacity; above 90%: activate pre-surge planning
Surge Protocol Surge protocol activation at >95% predicted occupancy; includes discharge acceleration, elective case review, and regional transfer coordination
OR Utilization OR utilization target >80% of allocated block time; unused block released at T-72 hours; chronic underutilization (<70% for 3 months) triggers block reallocation
Discharge Timing Discharge before noon target >40%; barriers-to-discharge huddle daily at 10 AM; pending discharges visible on real-time capacity dashboard
Staffing Ratios Staffing ratios per state mandate with acuity-based adjustment; understaffing triggers float pool activation then agency escalation
Agency Nurse Cap Agency nurse hours capped at <5% of total nursing hours; exceeding cap for >2 consecutive pay periods triggers workforce planning review

5. Quality Measure Policy

ID: POL-QUAL-001 | Regulatory: CMS / TJC / HEDIS | Systems: EHR, Infection Control, Quality

Rule Area Key Rules
HAI Targets CLABSI <0.8 per 1,000 central line-days; CAUTI <1.0 per 1,000 catheter-days; SSI below NHSN benchmark; breaches trigger unit-level root cause analysis
Fall Rate Fall rate target <2.5 per 1,000 patient-days; falls with injury trigger immediate safety huddle and 24-hour post-fall assessment
Adverse Event Reporting Adverse event reporting within 24 hours for serious events; near-miss reporting encouraged (non-punitive); sentinel events reported to TJC within required timeframe
Quality Measure Compliance Quality measure compliance >90% across CMS/TJC core measures; measures below 75th percentile benchmarked for focused improvement
Antibiotic Stewardship Antibiotic stewardship compliance target >85%; 48-hour antibiotic timeout review mandatory; culture-directed de-escalation tracked
Safety Assessment Frequency Fall risk assessment: every shift and on transfer; pressure injury risk assessment: every shift for high-risk patients; reassessment on clinical status change

6. Pharmacy & Formulary Policy

ID: POL-PHARM-001 | Regulatory: FDA / P&T | Systems: EHR, Pharmacy, Inventory

Rule Area Key Rules
Formulary Compliance Formulary compliance target >92%; non-formulary orders require clinical exception with P&T-approved criteria; compliance reported monthly
Generic Substitution Generic substitution mandatory unless clinical exception documented by prescriber; brand-only exceptions reviewed quarterly by P&T committee
Controlled Substance Waste Controlled substance waste requires dual-witness documentation; discrepancies investigated within 24 hours; patterns reported to Pharmacy Director and compliance
Dispense Anomaly Detection Nurse dispense volume >3σ above unit average triggers automated investigation flag; patterns reviewed weekly by Chief Pharmacy Officer
Expiry Waste Expiry waste target <1% of total inventory value; FEFO (first expiry, first out) dispensing enforced; monthly expiry report reviewed by Pharmacy Director
Critical Med Stockout Stockout of critical medications: emergency procurement within 4 hours; therapeutic substitution protocol activated; clinical notification to affected units
Formulary Changes All formulary additions, deletions, and restrictions require P&T committee approval; clinical evidence review and cost-effectiveness analysis mandatory

7. Data Freshness Policy

ID: POL-DATA-001 | Regulatory: FHIR / Interop | Systems: All

Clinical System SLAs

Source Data SLA
EHR (Epic/Cerner) Vitals, Orders, Results Real-time via HL7/FHIR (<1 min)
Laboratory Information System Lab_Result, Microbiology <15 min from resulted status
Radiology (PACS/RIS) Imaging results, Reports <30 min from finalized report
Pharmacy System Medication_Order, Dispense Real-time (<1 min)

Operational & Financial System SLAs

Source Data SLA
Revenue Cycle (Claims/Denials) Claim, Denial, Charge Daily sync (end of business day)
HIS (ADT/Bed Status) Bed_Census, ED_Arrival Real-time via ADT feeds
Population Health (Payer Claims) Payer claims, Quality gaps Monthly
Clinical NLP Clinical notes, Dictation <60 min from dictation completion

Staleness Rules

  • 2× SLA gap: alert Data Engineering and system owner
  • 3× SLA gap: mark data as stale; exclude from AI workflow inputs; notify clinical and operational stakeholders

8. Regulatory Reporting Policy

ID: POL-REG-001 | Regulatory: CMS / State / TJC | Systems: All

Rule Area Key Rules
CMS Quality Reports CMS quality reports filed before deadline (100% on-time target); draft completion required 10 business days before due date for review
Accreditation Readiness Accreditation readiness score maintained >95% at all times; mock survey conducted semi-annually; deficiencies remediated within 30 days
Policy Review Cycle All policies reviewed annually at minimum; policies impacted by regulatory changes reviewed within 30 days of effective date
Staff Training Regulatory and compliance training completion >98%; new hire training within 30 days of start; annual refresher tracked per employee
Regulatory Change Assessment Regulatory change impact assessment completed within 14 days of publication; affected policies, workflows, and systems identified and remediation planned
Consent Management Research consent renewal tracked with expiration alerts; re-consent required for protocol amendments; IRB approval status linked to consent records
Audit Trail All reporting data must have complete audit trail from source system to reported number; lineage documentation required for all regulatory submissions

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