Healthcare and Medical Supply Industry Solutions

Introduction

Healthcare organizations and medical supply distributors face unique regulatory requirements, compliance mandates, and operational challenges. Medical device tracking regulations (FDA UDI requirements, lot traceability), controlled substance management (DEA Schedule II-V tracking, disposal documentation), patient safety protocols (recall management, expiration monitoring), and billing compliance (insurance verification, prior authorization) require automated validation beyond standard Business Central capabilities.

Healthcare-specific challenges include medical device serialization and tracking, expiration date management across multiple inventory locations, controlled substance chain-of-custody documentation, temperature-sensitive product monitoring, regulatory compliance documentation (FDA, HIPAA, state regulations), insurance eligibility verification, prior authorization workflows, and medical coding validation.

QUALIA Rule Engine enables healthcare organizations to automate these specialized validations while maintaining compliance with healthcare regulations and industry standards.

Healthcare validation requirements:

Medical device unique device identification (UDI) validation
Lot and serial number traceability throughout supply chain
Expiration date monitoring with multiple alert thresholds
Controlled substance inventory controls and audit trails
Temperature-sensitive product handling protocols
Regulatory compliance documentation and retention
Insurance verification and authorization workflows
Medical coding accuracy and billing compliance

Part 1: Medical Device Tracking and UDI Compliance

UDI Barcode Validation

FDA requires unique device identification for medical devices through standardized barcodes containing device identifier (DI) and production identifier (PI).

Validation Set: Item - UDI Compliance - OnModify

Rule 1: Validate UDI Structure for Implantable Devices

Table: Item (27)

Condition:

[27:CustomDeviceClass] is in ('Class III', 'Implantable')
AND [27:CustomUDI]

Action - Message:

Type: Error

Message:
UDI REQUIRED FOR MEDICAL DEVICE

Item: [27:1] - [27:3]
Device Class: [27:CustomDeviceClass]

Rule 2: Parse and Validate UDI Format

Condition:

[27:CustomUDI] is not ''
AND LENGTH([27:CustomUDI]

Action - Message:

Type: Error

Message:
INVALID UDI FORMAT

Item: [27:3]
UDI Entered: [27:CustomUDI]
Length: [LENGTH([27:CustomUDI]

Lot and Serial Traceability

Rule 3: Enforce Lot Tracking for Regulated Devices

Validation Set: Item Ledger Entry - Lot Traceability - OnPost

Source References:

1. Item (27)
   Link via: [32:5] = [27:1]

Condition:

[27:CustomRequiresLotTracking] is true
AND [32:CustomLotNo]

Action - Message:

Type: Error

Message:
LOT NUMBER REQUIRED

Item: [27:3]
Transaction Type: [32:7]
Quantity: [32:8]

This medical device requires lot number tracking for:
- FDA traceability requirements
- Recall management
- Expiration tracking
- Patient safety

Enter manufacturer's lot number before posting transaction.

Lot number format: [Manufacturer Code]-[Production Date]-[Sequence]

Rule 4: Cross-Reference Serial Numbers to Patient Records

Validation Set: Sales Line - Implantable Device Sale - OnPost

Condition:

[Item:CustomImplantable] is true
AND [37:CustomSerialNumber] is not ''
AND [37:CustomPatientID]

Action - Message:

Type: Error

Message:
PATIENT IDENTIFICATION REQUIRED FOR IMPLANT

Device: [Item:3]
Serial Number: [37:CustomSerialNumber]
Order: [37:3]

Part 2: Expiration Date Management

Multi-Threshold Expiration Alerts

Healthcare products require multiple alert levels as expiration approaches.

Validation Set: Item - Expiration Monitoring - Scheduled Daily

Rule 1: Critical Expiration Warning (30 Days)

Table: Item Ledger Entry (32)

Source References:

1. Item (27)
   Link via: [32:5] = [27:1]

2. Location (14)
   Link via: [32:2] = [14:1]

Condition:

[32:CustomExpirationDate] <= [T] + 30
AND [32:CustomExpirationDate] > [T]
AND [32:50]

Action - Email:

To: inventory.manager@hospital.com, pharmacy@hospital.com
Subject: CRITICAL - Medical Supplies Expiring Within 30 Days
Body:
URGENT EXPIRATION ALERT

The following medical supplies expire within 30 days:

Item: [27:3]
Lot Number: [32:CustomLotNo]
Location: [14:2]
Expiration Date: [32:CustomExpirationDate]
Days Until Expiration: [[32:CustomExpirationDate] - [T]]
Remaining Quantity: [32:50]
Value: $[[32:50] * [27:22]]

IMMEDIATE ACTION REQUIRED:
1. Prioritize use in patient care (if within policy)
2. Transfer to locations with higher usage
3. Return to supplier if eligible
4. Document disposal if expired

Device Class: [27:CustomDeviceClass]
Manufacturer: [27:CustomManufacturer]

FDA Reporting: [IF([27:CustomDeviceClass]

Rule 2: Proactive Reordering (90-Day Alert)

Condition:

[32:CustomExpirationDate] <= [T] + 90
AND [32:CustomExpirationDate] > [T] + 30
AND [Item:Inventory] < [Item:15]

Action - Email:

To: purchasing@hospital.com
Subject: Reorder Alert - Expiring Inventory + Low Stock
Body:
PROACTIVE REORDERING RECOMMENDED

Item: [Item:3]
Current Inventory: [Item:Inventory]
Reorder Point: [Item:15]

Inventory Status:
- Expiring Soon: [32:50] units on [32:CustomExpirationDate]
- Net Available After Expiration: [Item:Inventory - 32:50]
- Will Be Below Reorder Point: [IF([Item:Inventory - 32:50] < [Item:15], 'YES', 'NO')]

Recommendation: Order [Item:16] units now to maintain stock levels after expiration.

Preferred Vendor: [Item:CustomPreferredVendor]
Average Lead Time: [Item:CustomLeadTime] days
Order Before: [[32:CustomExpirationDate] - [Item:CustomLeadTime]

Expiration-Based Inventory Selection

Rule 3: FEFO Enforcement (First Expired, First Out)

Validation Set: Warehouse Pick - FEFO Validation - OnCreate

Source References:

1. Item Ledger Entry (32) - Earlier Expiration
   Link via: [Pick:ItemNo] = [32:5]
   Reference Filters:
     [32:CustomExpirationDate] < [CurrentPick:ExpirationDate]
     [32:50] > 0
     [32:2] = [CurrentPick:Location]

Condition:

Action - Message:

Type: Warning

Message:
FEFO VIOLATION - EARLIER EXPIRATION AVAILABLE

Picking Item: [Pick:ItemNo]
Selected Lot: [CurrentPick:LotNo]
Selected Expiration: [CurrentPick:ExpirationDate]

Earlier expiring lots available:
[LIST(32:CustomLotNo, 32:CustomExpirationDate, 32:50) ORDER BY 32:CustomExpirationDate]

Part 3: Controlled Substance Management

DEA Schedule Tracking and Authorization

Controlled substances require strict inventory controls and authorization.

Validation Set: Item - Controlled Substance Setup - OnModify

Rule 1: Enforce DEA Schedule Documentation

Table: Item (27)

Condition:

[27:CustomControlledSubstance] is true
AND [27:CustomDEASchedule]

Action - Message:

Type: Error

Message:
DEA SCHEDULE CLASSIFICATION REQUIRED

Item: [27:3]

Rule 2: Controlled Substance Dispensing Authorization

Validation Set: Sales Line - Controlled Substance Sale - OnValidate

Source References:

1. Item (27)
   Link via: [37:6] = [27:1]

2. Customer (18)
   Link via: [SalesHeader:2] = [18:1]

Condition:

[27:CustomDEASchedule] is in ('II', 'III', 'IV')
AND [37:CustomPrescriptionNumber]

Action - Message:

Type: Error

Message:
PRESCRIPTION REQUIRED FOR CONTROLLED SUBSTANCE

Item: [27:3]
DEA Schedule: [27:CustomDEASchedule]

Controlled substances require prescription documentation:

Required Information:
- Prescription Number
- Prescriber Name and DEA Number
- Patient Name
- Prescription Date
- Quantity Authorized
- Refills Allowed (if applicable)

[IF([27:CustomDEASchedule] is 'II',
  'Schedule II: Written prescription required, NO REFILLS permitted',
  'Schedule III-IV: Written or oral prescription, refills permitted per prescriber authorization'
)]

Enter prescription details before proceeding with sale.

Customer DEA License: [18:CustomDEALicense]
License Status: [18:CustomDEALicenseStatus]
Expiration: [18:CustomDEALicenseExpiration]

Chain of Custody Documentation

Rule 3: Controlled Substance Transfer Documentation

Validation Set: Transfer Order - Controlled Substance Transfer - OnPost

Condition:

[TransferLine:Item:CustomDEASchedule] is not ''
AND [TransferHeader:CustomAuthorizedBy]

Action - Message:

Type: Error

Message:
CONTROLLED SUBSTANCE TRANSFER AUTHORIZATION REQUIRED

Transfer Order: [TransferHeader:No]
From Location: [TransferHeader:FromLocation]
To Location: [TransferHeader:ToLocation]

Controlled Substances Included:
[FOR EACH TransferLine WHERE Item.DEASchedule <> '':
  Item: [TransferLine:Item:Description]
  DEA Schedule: [TransferLine:Item:CustomDEASchedule]
  Quantity: [TransferLine:Quantity]
]

DEA Regulations require documented chain of custody:

Required Documentation:
☐ Authorized by: [Name and title]
☐ Received by: [Name and title at destination]
☐ Transfer Date and Time
☐ Reason for Transfer
☐ Vehicle/Transport Method
☐ Security Seal Numbers (if applicable)

Both locations must maintain DEA registration for controlled substances being transferred.

From Location DEA: [FromLocation:CustomDEARegistration]
To Location DEA: [ToLocation:CustomDEARegistration]

Part 4: Temperature-Sensitive Product Controls

Cold Chain Monitoring

Temperature-sensitive medical products require environmental monitoring throughout storage and transport.

Validation Set: Item - Temperature Requirements - OnModify

Rule 1: Validate Temperature Range Configuration

Condition:

[27:CustomTemperatureSensitive] is true
AND ([27:CustomMinTemp] is 0 OR [27:CustomMaxTemp]

Action - Message:

Type: Error

Message:
TEMPERATURE RANGE REQUIRED

Item: [27:3]

This item is marked as temperature-sensitive and requires storage temperature specifications:

Common Temperature Ranges:
- Frozen: -20°C to -10°C (-4°F to 14°F)
  Example: Certain vaccines, blood products

- Refrigerated: 2°C to 8°C (36°F to 46°F)
  Example: Insulin, most vaccines, biologics

- Controlled Room Temperature: 20°C to 25°C (68°F to 77°F)
  Example: Most pharmaceuticals

- Do Not Freeze: 15°C to 30°C (59°F to 86°F)
  Example: Liquid medications that degrade if frozen

Enter minimum and maximum storage temperatures.

Manufacturer Specifications: [27:CustomManufacturerSpecs]
USP Guidelines: [27:CustomUSPCategory]

Rule 2: Temperature Excursion Alert

Validation Set: Warehouse Receipt - Temperature Verification - OnPost

Source References:

1. Temperature Log (Custom Table)
   Link via: [Receipt:Location] = [TempLog:Location]
   Reference Filters:
     [TempLog:DateTime] >= [Receipt:DateTime]

Condition:

[Item:CustomTemperatureSensitive] is true
AND (MIN(TempLog:Temperature) < [Item:CustomMinTemp] 
     OR MAX(TempLog:Temperature) > [Item:CustomMaxTemp]

Action - Confirmation:

Message:
TEMPERATURE EXCURSION DETECTED

Item: [Item:3]
Required Range: [Item:CustomMinTemp]°C to [Item:CustomMaxTemp]°C

Temperature Log - Past 24 Hours at [Receipt:Location]:
Minimum Recorded: [MIN(TempLog:Temperature)]°C
Maximum Recorded: [MAX(TempLog:Temperature)]°C
Excursion Duration: [Calculate duration outside range]

Part 5: Insurance Verification and Prior Authorization

Real-Time Eligibility Checking

Validation Set: Sales Order - Insurance Verification - OnInsert

Rule 1: Verify Insurance Eligibility

Source References:

1. Customer (18) - Patient
   Link via: [36:2] = [18:1]

2. Insurance Coverage (Custom Table)
   Link via: [18:1] = [Coverage:PatientNo]
   Reference Filters:
     [Coverage:EffectiveDate] <= [T]
     [Coverage:ExpirationDate] >= [T]

Condition:

[36:CustomRequiresInsurance]

Action - Message:

Type: Warning

Message:
NO ACTIVE INSURANCE COVERAGE FOUND

Patient: [18:2]
Patient ID: [18:1]
Order Date: [T]

Prior Authorization Enforcement

Rule 2: Require Prior Authorization for DME

Validation Set: Sales Line - DME Authorization - OnValidate

Condition:

[Item:CustomDMECategory] is in ('Power Wheelchairs', 'Hospital Beds', 'Oxygen Equipment')
AND [37:CustomPriorAuthNumber] is ''
AND [Customer:CustomPrimaryInsurance]

Action - Message:

Type: Error

Message:
PRIOR AUTHORIZATION REQUIRED

Item: [Item:3]
Category: [Item:CustomDMECategory]
Patient: [Customer:2]
Insurance: [Customer:CustomPrimaryInsurance]

This durable medical equipment requires prior authorization from insurance.

Authorization Process:
1. Submit prior authorization request to insurance
2. Include:
   - Physician order/prescription
   - Medical necessity documentation
   - HCPCS code: [Item:CustomHCPCSCode]
   - Estimated cost
3. Obtain authorization number
4. Enter authorization in Prior Auth Number field

Typical Processing Time: 3-10 business days

Without authorization, claim will be denied and patient responsible for full cost.

Insurance Contact: [Customer:CustomInsurancePhone]
Authorization Fax: [Customer:CustomInsuranceAuthFax]

Part 6: Medical Coding and Billing Compliance

HCPCS Code Validation

Validation Set: Sales Line - Medical Coding - OnValidate

Rule 1: Validate HCPCS Code Structure

Condition:

[Item:CustomBillable] is true
AND [Item:CustomHCPCSCode]

Action - Message:

Type: Error

Message:
HCPCS CODE REQUIRED FOR BILLING

Item: [Item:3]

Rule 2: Cross-Validate Diagnosis and Procedure Codes

Validation Set: Sales Order - Medical Necessity - OnRelease

Source References:

1. Order Diagnosis Codes (Custom Table)
   Link via: [36:3] = [OrderDx:OrderNo]

Condition:

[36:CustomRequiresMedicalNecessity]

Action - Message:

Type: Error

Message:
DIAGNOSIS CODE REQUIRED FOR MEDICAL NECESSITY

Order: [36:3]
Patient: [Customer:2]

Medicare and most insurance carriers require diagnosis codes demonstrating medical necessity for covered items.

Required: ICD-10-CM Diagnosis Code(s)

Example Requirements:
- Oxygen Equipment: Requires pulmonary diagnosis (J44.9 COPD, J96.11 Chronic Respiratory Failure)
- Diabetic Supplies: Requires diabetes diagnosis (E11.9 Type 2 Diabetes)
- Wheelchairs: Requires mobility impairment diagnosis (M62.81 Muscle Weakness)

Enter diagnosis codes before releasing order.

Ordering Physician: [36:CustomPhysician]
Physician NPI: [36:CustomPhysicianNPI]

Part 7: Recall Management and Patient Safety

Product Recall Processing

Validation Set: Item - Recall Alert - Scheduled

Rule 1: Identify Affected Inventory

Source References:

1. FDA Recall Database (Custom Table)
   Link via: [27:CustomManufacturer] = [Recall:Manufacturer]
          AND [27:1] LIKE [Recall:ProductPattern]

2. Item Ledger Entry (32)
   Link via: [27:1] = [32:5]
   Reference Filters:
     [32:CustomLotNo] = [Recall:LotNumber]
     [32:50]

Condition:

COUNT(Recall:*) > 0
AND [Recall:Status]

Action - Email:

To: quality@hospital.com, inventory@hospital.com, pharmacy@hospital.com
CC: risk.management@hospital.com
Subject: URGENT - FDA PRODUCT RECALL AFFECTS INVENTORY
Body:
*** IMMEDIATE ACTION REQUIRED ***

FDA RECALL NOTIFICATION

Manufacturer: [Recall:Manufacturer]
Product: [27:3]
Recall Class: [Recall:RecallClass]

Class I: Dangerous/defective product that could cause serious injury or death
Class II: Product may cause temporary/reversible adverse health consequences
Class III: Product not likely to cause adverse health consequences

Recall Reason: [Recall:Reason]
FDA Announcement: [Recall:AnnouncementDate]

AFFECTED INVENTORY IN OUR SYSTEM:
[FOR EACH 32 WHERE LotNo IN Recall:
  Location: [32:LocationCode]
  Lot Number: [32:CustomLotNo]
  Quantity: [32:50]
  Expiration: [32:CustomExpirationDate]
  Bin: [32:CustomBin]
]

REQUIRED ACTIONS:
1. IMMEDIATELY quarantine all affected inventory
2. Block all affected lots in system (prevent dispensing)
3. Identify patients who received affected lots (if already dispensed)
4. Notify patients and physicians per FDA guidance
5. Document recall actions in quality system
6. Arrange return to manufacturer per recall instructions
7. File FDA Medical Device Report (MDR) if required

Recall Instructions: [Recall:InstructionsURL]
FDA Recall Number: [Recall:FDARecallNumber]

Patient Safety Contact: [Contact information]

Summary and Key Takeaways

This guide covered healthcare and medical supply industry validations:

Medical device tracking with UDI compliance and lot traceability
Expiration management with multi-threshold alerts and FEFO enforcement
Controlled substance DEA schedule tracking and chain of custody
Temperature controls for cold chain integrity monitoring
Insurance verification with prior authorization workflows
Medical coding HCPCS and ICD-10 validation for billing compliance
Recall management for patient safety and regulatory response

Healthcare compliance benefits:

Automated FDA and DEA regulatory compliance
Patient safety through expiration and recall management
Reduced billing rejections with coding validation
Controlled substance accountability and audit trails
Temperature monitoring for product integrity
Insurance authorization enforcement
Complete traceability for medical devices

Implementation considerations:

Integration with FDA GUDID and recall databases
Temperature monitoring system interfaces
Insurance eligibility verification services
Electronic health record (EHR) connections
Pharmacy management system integration
Regulatory reporting automation

Related topics:

Blog 033: Performance Optimization (handling large medical transaction volumes)
Blog 034: Rule Set Organization (organizing by regulatory requirement)
Blog 036: Manufacturing Solutions (medical device production tracking)
Blog 039: Financial Services Solutions (insurance claim processing patterns)

This blog is part of the QUALIA Rule Engine series for Microsoft Dynamics 365 Business Central. Follow along as we explore business rule automation patterns.

Business Central

Triggering Power Automate Flows from Business Rules

Advanced Table Linking and Cross-Record Validation

Aggregate Calculations Across Related Records: Summing, Counting, and Analyzing Data

Automated Email Notifications from Business Rules

Automatically Setting Field Values with Assign Actions

Building an Approval Workflow: When Orders Need Manager Sign-Off

Building Commission Calculation Rules for Sales Teams: Automating Sales Incentives

Building Multi-Condition Validation Rules: Understanding Independent Condition Evaluation

Construction and Project-Based Industry Solutions

Creating Your First Business Rule: A Step-by-Step Beginner's Guide

Custom Validation Messages for Business Rules

Distribution and Logistics Industry Solutions

Energy and Utilities Industry Solutions

Financial Services Industry Solutions

Food and Beverage Industry Solutions

Government and Public Sector Procurement Solutions

Healthcare and Medical Supply Industry Solutions

How to Implement Credit Limit Validation in 10 Minutes

How to Link Multiple Tables for Complex Multi-Table Validation

How to Prevent Infinite Loops in Your Business Rules

How to Prevent Negative Inventory with Business Rules

How to Validate Customer Data Before Order Creation

Implementing Discount Authorization Rules: Control Pricing with Confidence

Implementing Required Field Validation: Ensuring Data Completeness

Interactive Confirmation Dialogs in Business Rules

Manufacturing Industry Solutions

Non-Profit and Grant Management Solutions

Performance Optimization for Business Rules

Pharmaceuticals and Life Sciences Solutions

Preventing Data Entry Errors: Validation Best Practices

Professional Services Industry Solutions

Real Estate and Property Management Solutions

Retail and Point-of-Sale Industry Solutions

Rule Groups and User Permissions: Controlling Who Gets Which Rules

Rule Set Organization and Maintenance

Rule Versioning and Change Management

Testing and Debugging QUALIA Business Rules

Transportation and Logistics Industry Solutions

Understanding the Rule Execution Pipeline: From Trigger to Action

Understanding Validation Scenarios and Timing

Using Old Value Placeholders for Change Detection and Validation

Understanding the Rule Execution Pipeline: From Trigger to Action

QUALIA Rule Engine operates as a sophisticated event-driven system that intercepts data changes in Business Central and evaluates configured business rules in real-time. Understanding the execution pipeline—how a database operation flows through trigger detection, scenario evaluation, condition processing, and action execution—is essential for advanced rule design, performance optimization, and troubleshooting.

Energy and Utilities Industry Solutions

Energy and utilities companies face complex regulatory requirements including FERC compliance, NERC reliability standards, environmental regulations, rate case filings, renewable energy credit tracking, interconnection agreements, demand response programs, and outage management protocols. Asset-intensive operations with critical infrastructure, regulatory cost recovery mechanisms, time-of-use pricing structures, and customer meter-to-cash processes demand automated validation beyond standard ERP capabilities.

Real Estate and Property Management Solutions

Real estate and property management companies require specialized business rules for lease administration, tenant billing, common area maintenance (CAM) reconciliation, security deposit tracking, maintenance workflow management, vacancy management, rent escalation calculations, and portfolio performance analysis. Multi-entity property ownership structures, percentage rent calculations, operating expense recoveries, lease abstraction accuracy, and compliance with lease accounting standards (ASC 842 / IFRS 16) demand automated validation beyond standard ERP capabilities.

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