Laboratory Information System Master Data & Configuration
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Laboratory Information System Master Data & Configuration

Master Data Inventory

ID Data Set Description Records (Est.) Source Owner Update Frequency Approver
MD-LIS-001 LOINC Code Set Standard codes for lab tests and result components ~95,000 Regenstrief Institute LOINC Lab Informatics Biannually (LOINC release) Lab Director
MD-LIS-002 Lab Test Catalog Facility-specific catalog of orderable lab tests mapped to LOINC/CPT ~2,000 Facility-defined Pathologist / Lab Director On test menu change; annual review Lab Director + Medical Executive Committee
MD-LIS-003 Panel Definitions Definitions of lab panels/profiles (CBC, BMP, LFT, etc.) ~100 Facility-defined Lab Supervisor On panel change; annual review Lab Director
MD-LIS-004 Reference Ranges Age/sex-specific normal ranges per test ~3,000 Manufacturer IFU + local validation Lab Director On method change; annual review Lab Director
MD-LIS-005 Critical Value Thresholds Test-specific critical low/high thresholds and escalation rules ~200 Facility-defined clinical policy Pathologist / Lab Director Annual review; on guideline change Lab Director + Clinical Governance Committee
MD-LIS-006 Specimen Type Requirements Mapping of tests to required specimen types, tubes, volumes ~500 Test catalog + collection guide Lab Supervisor On test/specimen change Lab Supervisor
MD-LIS-007 Analyzer Configuration Master list of analyzers and capabilities ~50 Vendor specs + site config Lab Supervisor On equipment change Lab Director
MD-LIS-008 Westgard QC Rules QC rule sets applied per test/analyzer ~10 Industry standard QC Officer Rare; on QC program change Lab Director
MD-LIS-009 Antibiotic Master List List of antibiotics for microbiology sensitivity reporting ~100 Facility formulary + CLSI/EUCAST Microbiologist Annual Pharmacy & Therapeutics Committee
MD-LIS-010 Organism Code Set (SNOMED) SNOMED CT organism codes used in microbiology ~20,000 SNOMED CT Microbiology Informatics With SNOMED releases Microbiology Lead
MD-LIS-011 Reference Laboratory Directory Contracted reference labs and their codes ~10 Contracts with reference labs Lab Director On contract change Hospital Administration
MD-LIS-012 Specimen Rejection Reason Codes Standardised reasons for specimen rejection ~20 Facility-defined Lab Supervisor Rare; annual review Lab Director
MD-LIS-013 Lab Sections & Work Areas Logical lab sections (chemistry, hematology, micro, etc.) 10–30 Facility-defined Lab Supervisor Rare; on reorganisation Lab Director
MD-LIS-014 Result Status Codes Standard result statuses (preliminary, final, corrected, etc.) 10–15 Facility-defined / HL7 mapping Lab Informatics Rare Lab Director
MD-LIS-015 Priority Codes Order priorities (STAT, urgent, routine, etc.) 5–10 Facility-defined Lab Supervisor Rare Lab Director
MD-LIS-016 NABIDH/Malaffi Lab Code Mapping Mapping of local tests to HIE-required codes ~1,000 DHA NABIDH / DOH Malaffi Lab Informatics On test change; HIE spec change IT / Integration Lead
MD-LIS-017 Tube / Container Types Standard tube/container types for collection 30–50 Vendor catalog + facility Lab Supervisor On supply change Lab Director
MD-LIS-018 Storage Location Codes Freezers, fridges, racks, shelves for specimens 50–200 Facility-defined Lab Supervisor On layout change Lab Supervisor
MD-LIS-019 Notification Methods Allowed methods for critical notifications (in-app, SMS, phone) 5–10 Facility-defined Lab Informatics Rare Clinical Governance Committee
MD-LIS-020 UAE Regulatory Lab Codes MOH/DOH/DHA lab-related codes where applicable 50–200 MOH, DOH, DHA Compliance Officer As regulations change Compliance Committee

Note: Patients, providers, encounters, facilities, departments, users, and payers are shared entities and are not redefined here. They are referenced via foreign keys as per shared entity rules.

Setup Sequence

Dependency Graph

flowchart TD A["Step 1: Shared Entities<br/>Facilities, Departments, Users, Providers"] --> B["Step 2: Lab Sections & Work Areas (MD-LIS-013)"] B --> C["Step 3: Tube / Container Types (MD-LIS-017)"] C --> D["Step 4: Storage Location Codes (MD-LIS-018)"] D --> E["Step 5: LOINC Code Set (MD-LIS-001)"] E --> F["Step 6: Organism Code Set (MD-LIS-010)"] E --> G["Step 7: Antibiotic Master List (MD-LIS-009)"] E --> H["Step 8: Lab Test Catalog (MD-LIS-002)"] H --> I["Step 9: Panel Definitions (MD-LIS-003)"] H --> J["Step 10: Specimen Type Requirements (MD-LIS-006)"] H --> K["Step 11: Reference Ranges (MD-LIS-004)"] H --> L["Step 12: Critical Value Thresholds (MD-LIS-005)"] B --> M["Step 13: Analyzer Configuration (MD-LIS-007)"] M --> N["Step 14: Westgard QC Rules (MD-LIS-008)"] H --> O["Step 15: NABIDH/Malaffi Lab Code Mapping (MD-LIS-016)"] P["Step 16: Result Status Codes (MD-LIS-014)"] --> Q["Step 18: LIS Operational Go-Live"] Q1["Step 17: Priority Codes (MD-LIS-015)"] --> Q Q2["Step 19: Specimen Rejection Reason Codes (MD-LIS-012)"] --> Q Q3["Step 20: Notification Methods (MD-LIS-019)"] --> Q Q4["Step 21: Reference Laboratory Directory (MD-LIS-011)"] --> Q Q5["Step 22: UAE Regulatory Lab Codes (MD-LIS-020)"] --> Q L --> Q N --> Q O --> Q

Load Sequence (Narrative)

  1. Foundation (shared): Ensure facilities, departments, users, providers, and payers are loaded from their owning modules.
  2. Organisational structure: Load Lab Sections & Work Areas (MD-LIS-013).
  3. Physical resources: Load Tube / Container Types (MD-LIS-017) and Storage Location Codes (MD-LIS-018).
  4. Terminology: Load LOINC Code Set (MD-LIS-001), Organism Code Set (MD-LIS-010), Antibiotic Master List (MD-LIS-009).
  5. Core catalog: Build Lab Test Catalog (MD-LIS-002) using LOINC, CPT, and local codes.
  6. Panels & specimens: Configure Panel Definitions (MD-LIS-003) and Specimen Type Requirements (MD-LIS-006).
  7. Clinical interpretation: Load Reference Ranges (MD-LIS-004) and Critical Value Thresholds (MD-LIS-005).
  8. Equipment & QC: Configure Analyzer Configuration (MD-LIS-007) and Westgard QC Rules (MD-LIS-008).
  9. Interoperability: Map NABIDH/Malaffi Lab Codes (MD-LIS-016) and UAE Regulatory Lab Codes (MD-LIS-020).
  10. Operational codes: Load Result Status Codes (MD-LIS-014), Priority Codes (MD-LIS-015), Specimen Rejection Reason Codes (MD-LIS-012), Notification Methods (MD-LIS-019), and Reference Laboratory Directory (MD-LIS-011).
  11. Go-live: Validate all mappings, run test orders, and sign off for LIS go-live.

Master Data Specifications

Below are detailed specifications for key LIS master data sets. All tables must support bilingual fields (English/Arabic) where user-facing.

MD-LIS-001: LOINC Code Set

Purpose

Standardised international codes for lab tests and result components, required for:

  • Internal consistency across analyzers and lab sections
  • UAE HIE submissions (NABIDH, Malaffi) using LOINC
  • Interfacing with external systems (reference labs, EHR, analytics)

Schema

Table: md_lis_loinc_codes

Field Type Required Description
loinc_code VARCHAR(20) YES LOINC code (e.g., 718-7) — primary key
component VARCHAR(255) YES LOINC component name
property VARCHAR(50) NO LOINC property (e.g., MCnc)
time_aspect VARCHAR(50) NO Time aspect (e.g., Pt)
system VARCHAR(100) NO System (e.g., Bld)
scale VARCHAR(50) NO Scale (e.g., Qn)
method VARCHAR(100) NO Method (if specified)
display_name_en VARCHAR(255) YES Local English display name
display_name_ar VARCHAR(255) YES Local Arabic display name
is_orderable BOOLEAN YES TRUE if used as orderable test code
is_observable BOOLEAN YES TRUE if used as result component code
active_flag BOOLEAN YES Active/inactive in this facility
effective_from DATE YES Date activated in facility
effective_to DATE NO Date retired (NULL if active)

Sample Data

loinc_code component property time_aspect system scale method display_name_en display_name_ar is_orderable is_observable active_flag
718-7 Hemoglobin MCnc Pt Bld Qn Automated count Hemoglobin الهيموغلوبين TRUE TRUE TRUE
4548-4 Hematocrit VFr Pt Bld Qn Automated count Hematocrit الهيماتوكريت TRUE TRUE TRUE
2345-7 Glucose MCnc Pt Bld Qn Automated Glucose, plasma جلوكوز البلازما TRUE TRUE TRUE
2951-2 Sodium SCnc Pt Ser/Plas Qn ISE Sodium الصوديوم TRUE TRUE TRUE
777-3 Platelets NCnc Pt Bld Qn Automated count Platelet count عدد الصفائح الدموية TRUE TRUE TRUE
600-7 Potassium SCnc Pt Ser/Plas Qn ISE Potassium البوتاسيوم TRUE TRUE TRUE
6690-2 Leukocytes NCnc Pt Bld Qn Automated count WBC count عدد كريات الدم البيضاء TRUE TRUE TRUE

Data Governance

  • Owner: Lab Informatics
  • Approval: Lab Director
  • Update frequency: Biannually, aligned with official LOINC releases
  • Change process: 1. Download new LOINC release from Regenstrief. 2. Run comparison against existing table. 3. Add new codes; mark deprecated codes as inactive (do not delete). 4. Update local display names (EN/AR) where needed. 5. Notify integration team and analytics of any code changes impacting mappings.

Validation Rules

  • loinc_code must be unique and match regex ^[0-9]+-[0-9]+$.
  • display_name_en and display_name_ar must be non-empty for active codes.
  • effective_to must be NULL or greater than/equal to effective_from.
  • is_orderable OR is_observable must be TRUE (at least one).

MD-LIS-002: Lab Test Catalog

Purpose

Defines all orderable lab tests in the facility, linking local test codes to LOINC, CPT, lab section, specimen requirements, billing, and HIE mappings. Drives:

  • Order entry in CPOE and LIS
  • Analyzer worklists
  • Billing & claims (CPT)
  • NABIDH/Malaffi submissions

Schema

Table: md_lis_test_catalog

Field Type Required Description
test_code VARCHAR(30) YES Local test code (primary key)
display_name_en VARCHAR(255) YES Test name (English)
display_name_ar VARCHAR(255) YES Test name (Arabic)
loinc_code VARCHAR(20) YES FK → md_lis_loinc_codes.loinc_code
cpt_code VARCHAR(10) NO CPT code for billing
lab_section_code VARCHAR(30) YES FK → md_lis_lab_sections.section_code
default_priority_code VARCHAR(10) YES FK → md_lis_priority_codes.priority_code
specimen_type_code VARCHAR(30) YES FK → md_lis_specimen_type_requirements.specimen_type_code
tube_type_code VARCHAR(30) NO FK → md_lis_tube_types.tube_type_code
is_panel BOOLEAN YES TRUE if this is a panel (CBC, BMP)
active_flag BOOLEAN YES Active/inactive
effective_from DATE YES Activation date
effective_to DATE NO Deactivation date
reportable_to_hie BOOLEAN YES Whether sent to NABIDH/Malaffi
nabidh_code VARCHAR(50) NO NABIDH-specific code if required
malaffi_code VARCHAR(50) NO Malaffi-specific code if required

Sample Data

test_code display_name_en display_name_ar loinc_code cpt_code lab_section_code default_priority_code specimen_type_code tube_type_code is_panel reportable_to_hie
CBC Complete Blood Count عد دموي شامل 57021-8 85025 HEM ROUTINE WB_EDTA EDTA_LAV TRUE TRUE
FBS Fasting Blood Sugar سكر صائم 1558-6 82947 CHEM ROUTINE SERUM SST_GOLD FALSE TRUE
RBS Random Blood Sugar سكر عشوائي 2345-7 82947 CHEM ROUTINE SERUM SST_GOLD FALSE TRUE
LFT Liver Function Tests وظائف الكبد 24325-3 80076 CHEM ROUTINE SERUM SST_GOLD TRUE TRUE
CRP C-Reactive Protein البروتين المتفاعل C 1988-5 86140 IMM ROUTINE SERUM SST_GOLD FALSE TRUE
UCULT Urine Culture مزرعة بول 630-4 87086 MICRO ROUTINE URINE URINE_CUP FALSE TRUE
COVIDPCR SARS-CoV-2 PCR فحص PCR لفيروس كورونا 94309-2 87635 MICRO STAT NP_SWAB VTM_TUBE FALSE TRUE

Data Governance

  • Owner: Pathologist / Lab Director
  • Approval: Lab Director + Medical Executive Committee (for new tests)
  • Update frequency: On test menu changes; annual full review
  • Change process: 1. Request from lab section or clinical department. 2. Evaluate clinical utility, cost, and regulatory requirements. 3. Define test parameters (LOINC, CPT, specimen, section, HIE mapping). 4. Build and test in non-production. 5. Obtain approvals; schedule production deployment and communication to clinicians.

Validation Rules

  • test_code must be unique and non-null.
  • loinc_code must exist in md_lis_loinc_codes and be active.
  • lab_section_code, default_priority_code, specimen_type_code must reference active codes.
  • effective_to must be NULL or ≥ effective_from.
  • If reportable_to_hie = TRUE, at least loinc_code must be present; nabidh_code/malaffi_code as per local HIE spec.

MD-LIS-003: Panel Definitions

Purpose

Defines composition of multi-test panels (e.g., CBC, BMP, LFT), including component tests and display order. Used for:

  • Order entry convenience
  • Analyzer worklists
  • Result grouping in reports

Schema

Table: md_lis_panels

Field Type Required Description
panel_code VARCHAR(30) YES Local panel code (PK)
display_name_en VARCHAR(255) YES Panel name (English)
display_name_ar VARCHAR(255) YES Panel name (Arabic)
panel_loinc_code VARCHAR(20) NO Panel-level LOINC if available
lab_section_code VARCHAR(30) YES FK → md_lis_lab_sections.section_code
specimen_type_code VARCHAR(30) YES FK → md_lis_specimen_type_requirements.specimen_type_code
active_flag BOOLEAN YES Active/inactive
effective_from DATE YES Activation date
effective_to DATE NO Deactivation date

Table: md_lis_panel_components

Field Type Required Description
panel_code VARCHAR(30) YES FK → md_lis_panels.panel_code
component_test_code VARCHAR(30) YES FK → md_lis_test_catalog.test_code
display_order INT YES Order of display
is_required BOOLEAN YES If FALSE, optional component
default_included BOOLEAN YES Included by default when panel ordered

Sample Data

md_lis_panels

panel_code display_name_en display_name_ar panel_loinc_code lab_section_code specimen_type_code active_flag
CBC Complete Blood Count عد دموي شامل 57021-8 HEM WB_EDTA TRUE
BMP Basic Metabolic Panel تحليل كيمياء أساسي 24321-2 CHEM SERUM TRUE
LFT Liver Function Tests وظائف الكبد 24325-3 CHEM SERUM TRUE

md_lis_panel_components

panel_code component_test_code display_order is_required default_included
CBC WBC 1 TRUE TRUE
CBC RBC 2 TRUE TRUE
CBC HGB 3 TRUE TRUE
CBC HCT 4 TRUE TRUE
CBC PLT 5 TRUE TRUE
BMP NA 1 TRUE TRUE
BMP K 2 TRUE TRUE
BMP CL 3 TRUE TRUE
BMP CO2 4 TRUE TRUE
BMP BUN 5 TRUE TRUE
BMP CREAT 6 TRUE TRUE

Data Governance

  • Owner: Lab Supervisor
  • Approval: Lab Director
  • Update frequency: On panel composition changes; annual review
  • Change process: 1. Proposal from lab section or clinical department. 2. Assess impact on analyzers, billing, and HIE mappings. 3. Update panel definitions and test catalog relationships. 4. Test in non-production; communicate changes to clinicians.

Validation Rules

  • panel_code must exist as test_code in md_lis_test_catalog with is_panel = TRUE.
  • Each component_test_code must exist and be active.
  • display_order must be positive integer; no duplicates per panel_code.
  • At least one component per panel must have is_required = TRUE.

MD-LIS-004: Reference Ranges

Purpose

Defines normal reference ranges per test, age band, gender, and sometimes method. Used for:

  • Automatic abnormal flagging
  • Result interpretation
  • Auto-verification rules

Schema

Table: md_lis_reference_ranges

Field Type Required Description
range_id BIGINT YES PK (surrogate key)
test_code VARCHAR(30) YES FK → md_lis_test_catalog.test_code
age_min_years DECIMAL(4,1) YES Minimum age in years (inclusive)
age_max_years DECIMAL(4,1) YES Maximum age in years (inclusive)
gender CHAR(1) YES 'M', 'F', or 'A' (all)
low_value DECIMAL(12,4) YES Lower reference limit
high_value DECIMAL(12,4) YES Upper reference limit
unit VARCHAR(50) YES Unit (UCUM where possible)
method VARCHAR(100) NO Method if method-specific
effective_from DATE YES Activation date
effective_to DATE NO Deactivation date
source VARCHAR(255) YES Manufacturer IFU, local validation, etc.

Sample Data

range_id test_code age_min_years age_max_years gender low_value high_value unit source
1 HGB 18.0 150.0 M 13.0 17.0 g/dL Manufacturer IFU + local validation
2 HGB 18.0 150.0 F 12.0 15.0 g/dL Manufacturer IFU + local validation
3 FBS 18.0 150.0 A 70.0 99.0 mg/dL ADA guidelines + local validation
4 NA 18.0 150.0 A 135.0 145.0 mmol/L Manufacturer IFU
5 K 18.0 150.0 A 3.5 5.1 mmol/L Manufacturer IFU

Data Governance

  • Owner: Lab Director
  • Approval: Lab Director + Quality Committee
  • Update frequency: On method change; annual review
  • Change process: 1. New analyzer or method validation completed. 2. Proposed ranges documented with validation data. 3. Approval by Lab Director and Quality Committee. 4. Update reference ranges with effective date; do not overwrite historical ranges.

Validation Rules

  • age_max_years ≥ age_min_years.
  • No overlapping active ranges for same test_code + gender + age band.
  • low_value < high_value.
  • unit must match unit configured in analyzer and test catalog.

MD-LIS-005: Critical Value Thresholds

Purpose

Defines critical low/high thresholds per test and age group, plus notification requirements and escalation times, to support WF-LIS-005 (Critical Value Notification) and UAE regulatory expectations for timely communication.

Schema

Table: md_lis_critical_values

Field Type Required Description
critical_id BIGINT YES PK
test_code VARCHAR(30) YES FK → md_lis_test_catalog.test_code
age_group_code VARCHAR(20) YES e.g., ADULT, PED, NEO
gender CHAR(1) YES 'M', 'F', 'A'
critical_low DECIMAL(12,4) NO Critical low threshold (NULL if not applicable)
critical_high DECIMAL(12,4) NO Critical high threshold (NULL if not applicable)
unit VARCHAR(50) YES Unit
notification_required BOOLEAN YES Whether notification is mandatory
escalation_minutes_level1 INT YES Minutes before first escalation
escalation_minutes_level2 INT YES Minutes before second escalation
active_flag BOOLEAN YES Active/inactive
effective_from DATE YES Activation date
effective_to DATE NO Deactivation date

Sample Data

test_code age_group_code gender critical_low critical_high unit notification_required escalation_minutes_level1 escalation_minutes_level2
K ADULT A 2.5 6.5 mmol/L TRUE 15 30
NA ADULT A 120.0 160.0 mmol/L TRUE 15 30
HGB ADULT A 6.0 20.0 g/dL TRUE 15 30
FBS ADULT A 40.0 400.0 mg/dL TRUE 15 30
PLT ADULT A 20.0 NULL x10^9/L TRUE 15 30

Data Governance

  • Owner: Pathologist / Lab Director
  • Approval: Clinical Governance Committee
  • Update frequency: Annual; on guideline changes
  • Change process: 1. Review international guidelines and local policies. 2. Propose changes with rationale. 3. Approval by Clinical Governance Committee. 4. Update thresholds and communicate to clinical staff.

Validation Rules

  • At least one of critical_low or critical_high must be non-null.
  • escalation_minutes_level2 ≥ escalation_minutes_level1.
  • No overlapping active records for same test_code + age_group_code + gender.

MD-LIS-006: Specimen Type Requirements

Purpose

Defines specimen types and their requirements (volume, tube, handling) per test. Supports:

  • WF-LIS-002 (Specimen Collection & Accessioning)
  • Phlebotomy worklists and collection guides
  • Analyzer suitability checks

Schema

Table: md_lis_specimen_type_requirements

Field Type Required Description
specimen_type_code VARCHAR(30) YES PK (e.g., WB_EDTA, SERUM)
display_name_en VARCHAR(100) YES English name
display_name_ar VARCHAR(100) YES Arabic name
primary_tube_type_code VARCHAR(30) YES FK → md_lis_tube_types.tube_type_code
min_volume_ml DECIMAL(6,2) YES Minimum required volume
handling_instructions_en VARCHAR(255) NO English instructions
handling_instructions_ar VARCHAR(255) NO Arabic instructions
active_flag BOOLEAN YES Active/inactive

Table: md_lis_test_specimen_map

Field Type Required Description
test_code VARCHAR(30) YES FK → md_lis_test_catalog.test_code
specimen_type_code VARCHAR(30) YES FK → md_lis_specimen_type_requirements.specimen_type_code
is_primary BOOLEAN YES Primary specimen type for test

Sample Data

md_lis_specimen_type_requirements

specimen_type_code display_name_en display_name_ar primary_tube_type_code min_volume_ml handling_instructions_en
WB_EDTA Whole blood (EDTA) دم كامل (EDTA) EDTA_LAV 2.0 Mix gently, do not freeze
SERUM Serum مصل الدم SST_GOLD 2.0 Allow to clot 30 min, centrifuge
PLASMA Plasma بلازما LITH_HEP 2.0 Centrifuge within 30 min
URINE Urine بول URINE_CUP 10.0 Midstream clean catch
NP_SWAB Nasopharyngeal swab مسحة أنفية بلعومية VTM_TUBE 1.0 Place swab in VTM, keep 2–8°C

Data Governance

  • Owner: Lab Supervisor
  • Approval: Lab Director
  • Update frequency: On test/specimen changes
  • Change process: 1. Update based on manufacturer IFU or new test. 2. Validate with phlebotomy and lab sections. 3. Update LIS and collection guides.

Validation Rules

  • min_volume_ml > 0.
  • Each active test_code must have at least one active specimen_type_code.
  • primary_tube_type_code must exist and be active in tube types.

MD-LIS-007: Analyzer Configuration

Purpose

Defines analyzers, their sections, connectivity, and capabilities. Supports:

  • WF-LIS-003 (Analyzer Interface & Result Capture)
  • QC management (WF-LIS-008)
  • Instrument routing and worklists

Schema

Table: md_lis_analyzers

Field Type Required Description
analyzer_id BIGINT YES PK
analyzer_code VARCHAR(30) YES Unique code
analyzer_name VARCHAR(255) YES Display name
manufacturer VARCHAR(100) YES Manufacturer
model VARCHAR(100) YES Model
serial_number VARCHAR(100) NO Serial number
facility_id BIGINT YES FK → facilities.facility_id
lab_section_code VARCHAR(30) YES FK → md_lis_lab_sections.section_code
ip_address VARCHAR(50) NO IP or host
interface_type VARCHAR(50) YES e.g., ASTM, HL7, TCP/IP
is_active BOOLEAN YES Active/inactive
last_maintenance_date DATE NO Last maintenance
next_maintenance_due DATE NO Next scheduled maintenance

Table: md_lis_analyzer_test_map

Field Type Required Description
analyzer_id BIGINT YES FK → md_lis_analyzers.analyzer_id
test_code VARCHAR(30) YES FK → md_lis_test_catalog.test_code
analyzer_test_code VARCHAR(30) YES Code used by analyzer
active_flag BOOLEAN YES Active/inactive

Sample Data

md_lis_analyzers

analyzer_id analyzer_code analyzer_name manufacturer model facility_id lab_section_code interface_type is_active
1 CHEM_AU5800 AU5800 Chemistry Analyzer Beckman Coulter AU5800 1 CHEM ASTM TCP/IP TRUE
2 HEM_XN1000 XN-1000 Hematology Analyzer Sysmex XN-1000 1 HEM HL7 TCP/IP TRUE
3 IMM_ARCHITECT Architect i2000SR Abbott i2000SR 1 IMM ASTM TCP/IP TRUE

md_lis_analyzer_test_map

analyzer_id test_code analyzer_test_code active_flag
1 FBS GLU TRUE
1 NA NA TRUE
1 K K TRUE
2 CBC CBC TRUE
2 PLT PLT TRUE

Data Governance

  • Owner: Lab Supervisor
  • Approval: Lab Director + IT/Integration Lead
  • Update frequency: On analyzer installation, decommission, or test menu change
  • Change process: 1. New analyzer implementation project. 2. Configure analyzer and LIS mapping tables. 3. Validate with parallel testing and QC. 4. Approve and move to production.

Validation Rules

  • analyzer_code must be unique.
  • analyzer_test_code must be unique per analyzer_id.
  • Only active analyzers and test mappings can be used in live orders.

MD-LIS-008: Westgard QC Rules

Purpose

Defines QC rule sets applied per test/analyzer combination to determine whether QC is in control, supporting WF-LIS-008 (Quality Control Management).

Schema

Table: md_lis_westgard_rules

Field Type Required Description
rule_code VARCHAR(20) YES PK (e.g., 1_2S, 1_3S)
display_name_en VARCHAR(100) YES English name
display_name_ar VARCHAR(100) YES Arabic name
description_en VARCHAR(255) NO English description
description_ar VARCHAR(255) NO Arabic description
active_flag BOOLEAN YES Active/inactive

Table: md_lis_qc_rule_sets

Field Type Required Description
rule_set_id BIGINT YES PK
analyzer_id BIGINT YES FK → md_lis_analyzers.analyzer_id
test_code VARCHAR(30) YES FK → md_lis_test_catalog.test_code
control_level VARCHAR(20) YES e.g., L1, L2
rule_code VARCHAR(20) YES FK → md_lis_westgard_rules.rule_code
active_flag BOOLEAN YES Active/inactive

Sample Data

md_lis_westgard_rules

rule_code display_name_en display_name_ar description_en
1_2S 1-2s rule قاعدة 1-2s Reject run if one control exceeds ±2 SD
1_3S 1-3s rule قاعدة 1-3s Reject run if one control exceeds ±3 SD
2_2S 2-2s rule قاعدة 2-2s Reject run if two consecutive controls exceed ±2 SD on same side
R_4S R-4s rule قاعدة R-4s Reject run if difference between two controls is ≥4 SD
4_1S 4-1s rule قاعدة 4-1s Reject run if four consecutive controls exceed ±1 SD on same side

md_lis_qc_rule_sets

rule_set_id analyzer_id test_code control_level rule_code active_flag
1 1 FBS L1 1_2S TRUE
2 1 FBS L1 1_3S TRUE
3 1 FBS L1 2_2S TRUE
4 1 FBS L1 R_4S TRUE
5 1 FBS L2 1_2S TRUE

Data Governance

  • Owner: QC Officer
  • Approval: Lab Director
  • Update frequency: Rare; on QC program changes
  • Change process: 1. QC program review and recommendation. 2. Update rule sets in LIS. 3. Validate with QC data and document rationale.

Validation Rules

  • Each active test_code + analyzer_id + control_level must have at least one rule.
  • rule_code must exist and be active.

MD-LIS-009: Antibiotic Master List

Purpose

Defines antibiotics used in microbiology sensitivity testing and reporting, including mapping to facility formulary and stewardship rules. Supports WF-LIS-006 (Microbiology Culture & Sensitivity) and antimicrobial stewardship.

Schema

Table: md_lis_antibiotics

Field Type Required Description
antibiotic_code VARCHAR(30) YES PK (e.g., CIPRO, CTX)
display_name_en VARCHAR(100) YES English name
display_name_ar VARCHAR(100) YES Arabic name
atc_code VARCHAR(20) NO ATC code if used
formulary_med_code VARCHAR(50) NO Link to medication formulary (CPOE)
is_restricted BOOLEAN YES Restricted antibiotic (stewardship)
cascade_level INT NO For cascade reporting (1 = narrow, higher = broader)
active_flag BOOLEAN YES Active/inactive

Sample Data

antibiotic_code display_name_en display_name_ar atc_code is_restricted cascade_level
AMP Ampicillin أمبيسيلين J01CA01 FALSE 1
AMC Amoxicillin/Clavulanate أموكسيسيلين/كلافولانات J01CR02 FALSE 1
CTX Cefotaxime سيفوتاكسيم J01DD01 TRUE 2
CIPRO Ciprofloxacin سيبروفلوكساسين J01MA02 TRUE 2
MERO Meropenem ميروبينيم J01DH02 TRUE 3
COL Colistin كوليستين J01XB01 TRUE 4

Data Governance

  • Owner: Microbiologist
  • Approval: Pharmacy & Therapeutics Committee
  • Update frequency: Annual; on formulary changes
  • Change process: 1. Align with facility formulary and CLSI/EUCAST guidelines. 2. Update antibiotic list and cascade levels. 3. Coordinate with Pharmacy and stewardship team.

Validation Rules

  • cascade_level must be positive integer if not NULL.
  • Restricted antibiotics must have stewardship rules configured in relevant module.

MD-LIS-010: Organism Code Set (SNOMED)

Purpose

Defines SNOMED CT organism codes used in microbiology results and antibiograms. Supports:

  • Structured reporting
  • HIE submissions (NABIDH/Malaffi)
  • Antibiogram generation

Schema

Table: md_lis_organisms

Field Type Required Description
snomed_code VARCHAR(20) YES PK
display_name_en VARCHAR(255) YES English name
display_name_ar VARCHAR(255) YES Arabic name
organism_group VARCHAR(100) NO e.g., Gram-negative, Gram-positive, Yeast
is_reportable BOOLEAN YES Reportable to clinicians
active_flag BOOLEAN YES Active/inactive

Sample Data

snomed_code display_name_en display_name_ar organism_group is_reportable
112283007 Escherichia coli الإشريكية القولونية Gram-negative TRUE
3092008 Staphylococcus aureus المكورات العنقودية الذهبية Gram-positive TRUE
68566005 Pseudomonas aeruginosa الزائفة الزنجارية Gram-negative TRUE
235865005 Klebsiella pneumoniae الكليبسيلا الرئوية Gram-negative TRUE
78048006 Candida albicans المبيضات البيضاء Yeast TRUE

Data Governance

  • Owner: Microbiology Informatics
  • Approval: Microbiology Lead
  • Update frequency: With SNOMED releases; annual review
  • Change process: 1. Import SNOMED organism subset. 2. Map to local display names (EN/AR). 3. Mark non-used organisms as inactive.

Validation Rules

  • snomed_code must be unique.
  • display_name_en and display_name_ar required for active codes.

MD-LIS-011: Reference Laboratory Directory

Purpose

Defines contracted reference laboratories and their identifiers, used in WF-LIS-007 (Reference Lab Send-Out) and billing.

Schema

Table: md_lis_reference_labs

Field Type Required Description
reference_lab_id BIGINT YES PK
lab_code VARCHAR(30) YES Unique code
name_en VARCHAR(255) YES English name
name_ar VARCHAR(255) YES Arabic name
moh_facility_code VARCHAR(50) NO MOH facility code if applicable
doh_facility_code VARCHAR(50) NO DOH facility code if applicable
dha_facility_code VARCHAR(50) NO DHA facility code if applicable
address_en VARCHAR(255) NO Address (English)
address_ar VARCHAR(255) NO Address (Arabic)
contact_phone VARCHAR(30) NO Contact number
active_flag BOOLEAN YES Active/inactive

Sample Data

lab_code name_en name_ar moh_facility_code contact_phone
NRL_DXB National Reference Lab Dubai المختبر المرجعي الوطني دبي MOH-LAB-001 +971 4 123 4567
NRL_AUH National Reference Lab Abu Dhabi المختبر المرجعي الوطني أبوظبي MOH-LAB-002 +971 2 234 5678
INTL_MAYO Mayo Clinic Reference Lab مختبر مايو كلينك المرجعي NULL +1 507 284 2511

Data Governance

  • Owner: Lab Director
  • Approval: Hospital Administration + Contracts
  • Update frequency: On contract changes
  • Change process: 1. New contract or termination. 2. Update directory and send-out mappings. 3. Notify billing and logistics.

Validation Rules

  • lab_code must be unique.
  • At least one of MOH/DOH/DHA codes should be populated for UAE-based labs.

MD-LIS-012: Specimen Rejection Reason Codes

Purpose

Standardises reasons for specimen rejection to support KPI “Specimen Rejection Rate” and quality improvement.

Schema

Table: md_lis_rejection_reasons

Field Type Required Description
reason_code VARCHAR(20) YES PK
display_name_en VARCHAR(100) YES English description
display_name_ar VARCHAR(100) YES Arabic description
category VARCHAR(50) NO e.g., Pre-analytical, Analytical
active_flag BOOLEAN YES Active/inactive

Sample Data

reason_code display_name_en display_name_ar category
HEMOLYZED Hemolyzed specimen عينة منحلة الدم Pre-analytical
CLOTTED Clotted specimen عينة متخثرة Pre-analytical
INSUFF_VOL Insufficient volume حجم غير كافٍ Pre-analytical
WRONG_TUBE Wrong tube type أنبوب غير مناسب Pre-analytical
LEAKAGE Leaking container أنبوب/حاوية مسربة Pre-analytical

Data Governance

  • Owner: Lab Supervisor
  • Approval: Lab Director
  • Update frequency: Rare; annual review
  • Change process: 1. Quality review identifies need for new code. 2. Add code and update training materials.

Validation Rules

  • reason_code must be unique.
  • Cannot delete codes referenced in historical specimens; only inactivate.

MD-LIS-013: Lab Sections & Work Areas

Purpose

Defines logical lab sections used for routing, worklists, and reporting.

Schema

Table: md_lis_lab_sections

Field Type Required Description
section_code VARCHAR(30) YES PK (e.g., CHEM, HEM)
display_name_en VARCHAR(100) YES English name
display_name_ar VARCHAR(100) YES Arabic name
active_flag BOOLEAN YES Active/inactive

Sample Data

section_code display_name_en display_name_ar
CHEM Clinical Chemistry الكيمياء السريرية
HEM Hematology أمراض الدم
IMM Immunology علم المناعة
MICRO Microbiology الأحياء الدقيقة
PATH Pathology علم الأمراض
POC Point-of-Care Testing الفحوصات السريرية السريعة

Data Governance

  • Owner: Lab Supervisor
  • Approval: Lab Director
  • Update frequency: Rare
  • Change process: Only when lab reorganises; requires careful review of all mappings.

Validation Rules

  • section_code must be unique.
  • All tests must reference a valid, active section.

MD-LIS-014: Result Status Codes

Purpose

Standardises result statuses and maps them to HL7/FHIR equivalents (e.g., P preliminary, F final, C corrected).

Schema

Table: md_lis_result_status_codes

Field Type Required Description
status_code VARCHAR(10) YES PK (internal code)
display_name_en VARCHAR(50) YES English name
display_name_ar VARCHAR(50) YES Arabic name
hl7_status_code VARCHAR(5) YES HL7 v2 status (e.g., P, F, C)
fhir_status_code VARCHAR(20) YES FHIR status (e.g., preliminary, final, amended)
active_flag BOOLEAN YES Active/inactive

Sample Data

status_code display_name_en display_name_ar hl7_status_code fhir_status_code
PRELIM Preliminary مبدئي P preliminary
FINAL Final نهائي F final
CORR Corrected مصحح C amended
CANCEL Cancelled ملغى X cancelled
PARTIAL Partial جزئي P partial

Data Governance

  • Owner: Lab Informatics
  • Approval: Lab Director
  • Update frequency: Rare
  • Change process: Only to align with HL7/FHIR or HIE requirements.

Validation Rules

  • hl7_status_code and fhir_status_code must be consistent with standards.
  • Only active codes can be used in new results.

MD-LIS-015: Priority Codes

Purpose

Defines order priorities (STAT, urgent, routine) used in worklists and TAT KPIs.

Schema

Table: md_lis_priority_codes

Field Type Required Description
priority_code VARCHAR(10) YES PK
display_name_en VARCHAR(50) YES English name
display_name_ar VARCHAR(50) YES Arabic name
hl7_priority_code VARCHAR(5) YES HL7 order priority (e.g., S, R)
tat_target_minutes INT YES Target TAT in minutes
active_flag BOOLEAN YES Active/inactive

Sample Data

priority_code display_name_en display_name_ar hl7_priority_code tat_target_minutes
STAT STAT عاجل جداً S 60
URGENT Urgent عاجل A 120
ROUTINE Routine روتيني R 240
PREOP Pre-operative قبل العملية P 90

Data Governance

  • Owner: Lab Supervisor
  • Approval: Lab Director
  • Update frequency: Rare
  • Change process: Update TAT targets as per service level agreements.

Validation Rules

  • tat_target_minutes > 0.
  • hl7_priority_code must align with HL7 v2 standard.

Configuration Parameters

Key LIS configuration parameters and governance.

Parameter Type Default Description Governance
max_results_per_search Integer 50 Max search results returned in worklists and result queries System Admin (with Lab Informatics)
default_lab_timezone String Asia/Dubai Time zone for all lab timestamps System Admin
auto_verification_enabled Boolean true Global toggle for auto-verification engine Lab Director
auto_verification_ruleset_id Integer 1 ID of ruleset used for auto-verification Lab Informatics
critical_alert_level1_minutes Integer 15 Minutes before first escalation for critical values Clinical Governance Committee
critical_alert_level2_minutes Integer 30 Minutes before second escalation Clinical Governance Committee
max_specimen_hold_days_chemistry Integer 7 Default specimen retention period (chemistry) Lab Supervisor
max_specimen_hold_days_hematology Integer 3 Default specimen retention period (hematology) Lab Supervisor
max_specimen_hold_days_microbiology Integer 30 Default specimen retention period (microbiology) Microbiologist
qc_required_per_shift Boolean true Require QC at start of each shift QC Officer
qc_lockout_on_fail Boolean true Block result release if QC out of control Lab Director
hie_submission_enabled_nabidh Boolean true Enable NABIDH result submission IT / Integration Lead
hie_submission_enabled_malaffi Boolean true Enable Malaffi result submission IT / Integration Lead
pdpl_data_retention_years Integer 25 Retention period for lab results per UAE PDPL and local policy Compliance Officer
anonymise_data_for_analytics Boolean true Use pseudonymisation for analytics exports Compliance Officer

Configuration Governance

  • Changes to clinical-impacting parameters (auto-verification, QC lockout, critical alert timings) require:
  • Lab Director approval
  • Clinical Governance Committee review
  • Documented risk assessment
  • Technical parameters (max_results_per_search, timezone) require:
  • System Admin + Lab Informatics approval
  • PDPL-related parameters (retention, anonymisation) require:
  • Compliance Officer + Legal review

Data Load Procedures

1. Initial Load

External Sources

  • LOINC Code Set (MD-LIS-001):
  • Source: Official LOINC CSV from Regenstrief.
  • Format: CSV; import via ETL script mapping to md_lis_loinc_codes.
  • Validation:
    • Check code format and uniqueness.
    • Ensure mandatory fields populated.
  • SNOMED Organism Codes (MD-LIS-010):
  • Source: SNOMED CT release (organism subset).
  • Format: RF2 or CSV subset; transform to md_lis_organisms.
  • Antibiotic Master List (MD-LIS-009):
  • Source: Facility formulary export (from Pharmacy/CPOE).
  • Format: CSV/JSON; map to md_lis_antibiotics.

Facility-Defined Data

  • Lab Test Catalog, Panels, Specimen Requirements, Critical Values, Reference Ranges, Lab Sections, Tube Types, Rejection Reasons, Reference Labs:
  • Collected via structured Excel templates or CSV.
  • Reviewed and signed off by Lab Director.
  • Imported via admin UI or ETL scripts.

Import Steps

  1. Load foundational reference (LOINC, SNOMED, antibiotics).
  2. Load lab sections, tube types, storage locations.
  3. Load lab test catalog and panel definitions.
  4. Load reference ranges and critical values.
  5. Load analyzer configuration and QC rules.
  6. Load reference lab directory and HIE mappings.

2. Ongoing Synchronisation

  • LOINC: Biannual job to compare new release with existing table; generate change report; apply after Lab Director approval.
  • SNOMED: As per national licensing; update organism subset and mark deprecated codes inactive.
  • HIE mappings (NABIDH/Malaffi): Integration team updates mapping tables when HIE specifications change; regression testing required.
  • Reference labs: Manual updates when contracts change.

3. Import/Export Formats

  • Supported formats:
  • CSV (primary for bulk master data)
  • JSON (for API-based integrations with other hospital systems)
  • REST APIs (internal) for synchronising with CPOE, Pharmacy, and Billing modules.
  • Encoding: UTF-8 to support Arabic and English.

4. Validation on Import

For all master data imports:

  • Structural validation:
  • Required columns present.
  • Data types correct (numeric, dates, booleans).
  • Referential integrity:
  • Foreign keys (e.g., loinc_code, test_code, section_code) exist and active.
  • Business rules:
  • No overlapping reference ranges or critical values.
  • Unique codes (test_code, panel_code, reason_code, etc.).
  • Units consistent with analyzer and test catalog.

Error Handling

  • Records failing validation:
  • Logged with detailed error messages.
  • Not imported; summary report sent to Lab Informatics.
  • Partial success:
  • Valid records imported; invalid records reported.
  • Import job status stored for audit.

5. UAE Regulatory & PDPL Considerations

  • PDPL (Federal Decree-Law No. 45/2021):
  • Master data containing personal identifiers (e.g., reference lab contacts) must be protected with role-based access.
  • Audit logs for changes to clinically significant master data (test catalog, critical values, reference ranges).
  • DOH/DHA/MOH:
  • Ensure MOH/DOH/DHA facility and lab codes are maintained in Reference Lab Directory and UAE Regulatory Lab Codes.
  • HIE mappings must comply with NABIDH/Malaffi implementation guides.
  • Cybersecurity (ADHICS, TDRA/NESA):
  • Data load interfaces must use secure channels (SFTP, HTTPS).
  • Access to master data management screens restricted to authorised roles (Lab Supervisor, Lab Director, Lab Informatics, QC Officer).

This specification provides the development-ready definition of master data and configuration for the LIS module, aligned with UAE regulatory and interoperability requirements.

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content/clinical/lis/06-master-data.md Generated 2026-02-20 22:54