stdecg ihe-profile vorgehensweise dr. georg heidenreich, ihe deutschland e.v
TRANSCRIPT
STDeCGIHE-Profile
Vorgehensweise
Dr. Georg Heidenreich, IHE Deutschland e.V.
IHE Documents - Content
SCOPE Document• Vorhabensbeschreibung• Anwendungsszenario• Abgrenzung
TECHNICAL FRAMEWORK• Vol1: „Integration Profiles“ Architekturbausteine, statisches /dynamisches Modell• Vol2: „Transaction Specification“ Detail-Modelle für interne Daten und Nachrichten
IMPLEMENTATION GUIDE• Beschreibung einer konkreten Konfiguration und Architektur• Detail-Modell der Nachrichten, Aktor-Attribute und persistenten Daten• Technische Vokabularien für Terminologien und Klassifikationen• Datentypen
IHE Documents - Dependencies
SCOPE Document
TECHNICAL FRAMEWORK
IMPLEMENTATION GUIDE
eProcurement in the Hospital - Processes
CLINICAL PROCUREMENTSUPPLY CHAIN MEDICAL IT
Hospital Information SystemsLogistics IT
HL7 v2GS1EANCOM
SCOPE Document
TECHNICAL FRAMEWORK
IMPLEMENTATION GUIDE
eProcurement in the Hospital
• Catalogue Management• Stock Information• Supply
• Extended Catalogue• Assets Invested• Supply Chain Intelligence
• Master Data Quality• Logistics & Distribution
• Clinical Order• Approval• Non-SKU Order
• Delivery• Retoure
CLINICAL PROCUREMENTSUPPLY CHAIN MEDICAL IT
• Planned Procedure• Prescription• Approve Order• Administration / Dispensing
• Admin / Discharge / Transfer• Patient Privacy• Claims / Reimbursement
• Medical Reasoning• Batch / Device Recalls
IHE-Vorgehensweise–Technical Framework 1-Integration Profiles
(a) Problemstellung für das Profil, Lösungsmerkmale des Profils(b) Beschreibung der Architektur-Merkmale, Entkoppelung, Abhängigkeiten(c) Bezug zu existierenden Standards, Ausblick auf die Verwendung weiterer Standards(d) Abgrenzung des Profils (z.B. Security)
K.1 Actors / Transactions(a) statisches Modell / Diagramm, sowie Bezug zu kombinierbaren Profilen(b) Liste der Transaktionen jeweils für einen Aktor; mit Abhängigkeiten
(Beschreibung, wann Transaktionen "required" sind)
K.2. Profile Options – kombinierbare Aktoren anderer Profile (jeweils für jeden Aktor im Profile)
K.3. Process Flow (a) dynamisches Modell, Diagramm, (b) prosaische Beschreibung aus Anwendungssicht,
dabei u.U. auch Fallunterscheidungen
„Clinical Order“ Profile • Ordering one or more (SKU & non-SKU) Items by Users / Medical Professionals
– for supply purposes (storage in ward) or,
– for specific treatment (with patient relation via prescription or, planned procedure…) also including patient identity, treating org, prescribing clinician, administration advice
• A-priori checking based on catalog data plus roles/permissions (e.g. by product type)– Product type, Unit, Order Quantity
– Variation / Configuration
• A-posteriori modification of whole order – based on catalog data– Order routing
– Order permissions
– Attributes for Lot/Batch/Device-Identification
– Mandatory „Generika“ substitution
– Stock-Driven substitution SKUs
• The goods receiver usually is in the same organisation as the order placer• There may be a related patient / prescription but does not have to be• Optional generation of orders: The clinical order instance may be derived implicitly from
secondary info (consumption w/o order, e.g. in OR or Emergency Dept.)
„Clinical Order“ Profile (continued)• The order responder manages orders but does not keep stock and is not
necessarily the ultimate manufacturer / deliverer• The order placer sees catalogue entries and views orders, but does not manage
orders• Optional: Approval from authorized organizational unit• The „new order“ message is the first formal event and does not know or use an
order id (primary key)• Orders (and their primary keys) are managed by the Order Responder only• Order Placer fully defined by history of past messages• Response messages: Shipping Note, Shipping Status• Clinical order to use IHE Pharmacy models and formats• Shall also cover Stock movements / transfers between a central and a satellite
pharmacy, or between two satellite pharmacies, or between the central pharmacy and an automated dispenser...
• Order Placer uses “Order Item” for “New Order” and “Update Order ”• Order Responder answers with “Order Item Status” for “Order Status”• Still open: Prices, PLU, discount, tax, cost, retoure
„Catalogue Management“ Profile• Maintenance and Distribution of Catalogue Data
– New catalogue item– Update to catalogue item– Update to some attributes of an existing catalogue item
• Strategic purchase, supplier chain management• For each SKU: Identifiers & classifiers (secondary keys), unit of measure, prices,
discounts, tax, limit value, order routes/suppliers, grading, packaging, weight, handling notes, Asset/Trace Indicator, Lot Tracking Indicator, Handling Information, Storage Information, Configuration Options
• Main role is to wrap different sources for catalogue data
„Supply“ Profile
• Stock / Re-supply actors based on GS1 ORDER ITEM• Re-Ordering of selected Catalogue Items via the „Resupply“- Actor (cascadeable)• Stock-Level Monitoring• Blocking of items for future demand („Planned Procedure“)• Retoure• Shall also cover internal stock movements and transfers• Shall also cover numbers for accepted / rejected items of an order position
• Option for Delivery / Shipping Note: Identification of product instances, batch, lot• Managing Instance Database
„Stock Information“ Profile
• Stock Level Information for identified catalogue Items • Excluded: Identification of product instances
More Profiles in Implementation Guidance
• Planned Procedure
• Prescription
• Approve Order– Permission
– Modification (Substitution, Capping the ordered quantities)
– Needs secure exchange of order ID, and secured access to Acceptor
• Administration / Dispensing of items
• nonSKU-Order– Ordering a non-stock items / custom-made product / configured product / quantities
– Straight order, immediately forwarded to manufacturer
– Specific handling advice
– Value-Added
Profile-onlynot in Implementation Guidance
• Incoming Goods / Delivery / Retoure– Catalogue Item, non-SKU,– Tender Order– Partial Delivery– Consignment-Order, Consigment-Consumption
• Admin / Discharge / Transfer• Patient Privacy• Claims Management, Reimbursement, Payments
– Prices, Bills, Creditors, Debt, Dunning Letters– Statutory assurance coverage– Link to retoure for voucher– Care Documentation– Product Data Sheet ?– Case Data ? Patient-relation !
Profile-onlynot part of the Impl.Guidance
• Assets Invested (asset-tags on product / device)– Identification and Labelling of Assets– Tracking of Assets
• Supply Chain Intelligence– Freely designed evaluation of all transitional data as well as catalog data– Anonymisation or Pseudonymisation of identifying attributes– Out-of-scope: Patient Return Rate, Pay-For-Performance, any patient-centric evaluation
• Extended Catalogue – Product (Type) Specification, „product group“ – Provides applicable Guides and Rules , specific to each product / type– Asset- / Device-Tracking based on Inventory ID or UDI– Batch-Tracking based on „Los“ / „lot“-Documentation– Tracking & Recall– Patient-Related Instance Selection
Scope-only:Not in Technical Framework
• Logistics & Distribution Management– all real control, movement and tracking of goods– Internal stock movement– Return of products to previous level
• Masterfile / Data Quality / Validation– Data Schemata for transitional data and catalog data– Data quality, Dependency on processes ? ? – Validation(processes) for catalog data ?
• (Semantic) Medical Reasoning and Lookup– clinical/pharmacological knowledge for inference e.g. as a support when searching a product
• Batch / Device - Recalls / Tracking / Traceability / Vigilance – Device Tracing and Recalls– Pharmacovigilance
Scope:OUT
• Environment, Health and Safety– Hazardous Ingredients– Obsolescene of items in stock– Obsolescence of „in situ“ catheters and protheses ?– Workplace Safety
• Private Assurance • Patient Medication Quality
– „Arzneimitteltherapiesicherheit“(AMTS) medication (interaction) safety, in a medical assesssment before POCO
– Patient-centric collection and assessment of health data for pharmaceutical interaction Cross-Check (needs patient-ID and health data from multiple providers)
HospitalProcurement
Distributor/ Supplier
HospitalITPoint Of Care
HospitalStock & Pharmacy
Order Placer
Order Responder
Item Checker
Order Reviewer
New Order [SUP-3]
Order Status [SUP-4]
Check Item[SUP-1]
ReviewOrder[SUP6]
Update Order [SUP-5]
OrderDetails[SUP-7]
Item Consumer
Rule Consumer
Catalog Source
Rule Update [SUP-11]
Item Update [SUP-9]
Releaser Order Handler
ReleaseQuery
[SUP-39]
Release Notification
[SUP-40] Stock
Resupply
Refill [SUP-13] Refill Status [SUP-15]
Refill Update[SUP-16]
Resupply
Refill[SUP-13]
Refill Status [SUP-15]
Refill Update[SUP-16]
Acceptor Items Handler
Logistics Query[SUP-36]
Overview & System Architecture Example
HospitalIT
Point Of Care
HospitalStock & Pharmacy
Order Placer
Order Responder
Item Checker
Order Reviewer
New Order
Order Status
Check Item
ReviewOrder
Update Order
OrderDetails
Item Consumer
Rule Consumer
Catalog Source
Rule Update
Item Update
Releaser Order Handler
ReleaseQuery
Release Notification Stock
Catalog Management Architecture Example
HospitalProcurement
Distributor/ Supplier
Point Of Care
HospitalStock & Pharmacy
Order Placer
Order Responder
New Order
Order Status Update Order
Releaser Order Handler
ReleaseQuery
Release Notification Stock
Resupply
Refill Refill Status
Refill Update
Resupply
Refill Refill Status
Refill UpdateAcceptor Items Handler
Logistics Query
Order ProcessArchitecture Example
„Clinical Order“ TF 1 (Static Model)Order Placer
Order Responder
Item Checker
Order Reviewer
New Order [SUP-3]
Order Status [SUP-4]
Check Item[SUP-1]
Review Order[SUP6]
Order Details[SUP-7]
(responds synchronously)
ItemChecker provides general catalog data (product attributes and category; OrderReviewer provides order-based data for routing, discounting, etcAssumes: • Order consisting of one or more items, which are each either SKUs or non-SKUs• Item Checker to respond to each „Check Item“ immediately (trading units, unit of measure,
packaging, order routing, product family, order restrictions, handling restrictions, nonSKU-attributes )
• Order Responder creates & manages primary keys for each New Order and each Order Item• Order Status transaction may contain lot tracing data, material / instance tracing / UID / asset tag
Update Order [SUP-5]
Clinical Order (Data Model)
Catalog Item SKU-Identifier- primary key GTIN - secondary key Unit of measure
optional: Brand / Trade name Trade Quantities National Identifier (PZN) Purpose Substance Packaging weight / dimensions Price Information Handling Information Storage Information
Product Instance Prod. Serial Number – primary key UDID - secondary key GTIN Quantity Stock Location Stock Entry Time + Order x Order Position + Batch/Lot Number + Asset Identifier
A catalog item, that can be ordered. An ordered item in some existing procurement transaction
An identifyable product instance at some physical location
Order Status Order ID x Responder- primary key Responder ID
*1
Consumption / Prescription / Dispense
Procedure ID - primary Key Patient ID Prescriber ID +Handling Advice + Administration Advice
„Supply Chain“ „Medical IT“„Clinical Procurement“
Order Item Order ID x Responder x Order Position - primary key mood { request, confirm, deliver, reject, accept } GTIN quantity instance list / batch / lot
1
Order Request Order Author Delivery Address Billing Address + Approver
* 1
Order Request
Profile „Catalog Management“Item Consumer
Rule Consumer
Catalog Source
Can be played by: Order Placer, Order Responder, Item Checker
Can be played by: Order Placer, Order Responder , Order Reviewer
Rule Update [SUP-11]
Item Update [SUP-9]
CatalogSource provides product-related data to ItemConsumer and order-related data to Rule ConsumerAssumes: • Catalog data may contain „item-related“ information and „beyond item“ information (rules)• Both Update transactions are acknowledged by immediate responses
Profile „Supply“
Stock
Resupply
Refill[SUP-13]
Refill Update[SUP-16]
Stock & Resupply may order across organisation boundaries. Both actors may be RuleConsumers in thei respective organisation. Order Context is not available anymore ?? Assumes: • Order reflects an original order from some OrderPlacer• Resupply to create & manage primary keys for incoming Refill item orders• Can be cascaded
Resupply
Refill[SUP-13]
Refill Update[SUP-16]
Refill Status [SUP-15]
Refill Status [SUP-15]
Can be played by: Order Responder
Can be played by: Order Responder, Manufacturer
Profile „non-SKU Order“
Order Responder
Special order message with customization, configuration, labels, dimensions, manufacturing procedure etcAssumes: • Order consisting of one nonSKU item with custom / configuration info• Manufacturer creates & manages primary key for each incoming nonSKU Order• Manufacturer can also play „Stock“ actor in a cascaded setting
Manufacturer
nonSKU Order[SUP-18]
nonSKU Update[SUP-21]
nonSKU Status [SUP-20]
Profile „Claims and Payments“
Purchaser
Invoice Tracker
Claims TrackerPurchase [SUP-23]
Purchaser notifies ClaimsTracker who will then generate and submit and follow a new invoice Simple Case: Order Placer = Invoice Tracker = Purchaser (customer) Order Responder= Claims Tracker (supplier)Claims Tracker to generate invoice primary keys and payment reference informationAll application responses given synchronously
New Invoice [SUP-25]
Invoice Update[SUP-27]Can be played by: Order Filler, Stock,
Resupply
Profile „Assets Invested“
Order Placer
Order Responder Tracker
New Order [SUP-3]
Order Status [SUP-4]
Identify Item/Lot[SUP-29]
OrderFiler asks to generate an asset identifier and Tracker generates it and follows it.Assumes: • Tracker creates identification of item / lot & manages relation to Order Item• Order Status SUP-3 transaction may inform Order Placer about lot tracing data, material / instance
tracing / UID / asset tags• Tracker immediately responds with identification for Item or, a request to split an order item
Item Handler
(responds synchronously)
(responds synchronously)
Follow Item/Lot[SUP-31]
may be played by OrderPlacer
Profile „Supply Chain Intelligence“
SCI Collector Supply Manager
Query[SUP-33]
Assumes: • Supply Manager immediately responds with data retrieved
Can be played by any other actor
(responds synchronously)
Profile „Care Documentation“
Report Source Report Manager
Provide[SUP-34]
Assumes: • Provide TXN to identify the patient / procedure to which the reported items are dispensed• Docu Manager immediately responds with data retrieved
Can be played by any other actor
(responds synchronously)
Profile „Logistics and Distribution“
LAD Collector Logistics Manager
Logistics Query[SUP-35]
Assumes: • Logistics Manager immediately responds with data retrieved
Can be played by Order Placer, Order Filler, Resupply, Manufacturer
(responds synchronously)
Profile „Incoming Goods / Delivery“
AcceptorItems Handler
Logistics Query[SUP-36]
Assumes: • Items Handler immediately responds with data retrieved
Can be played by Order Placer, Order Responder, Resupply
(responds synchronously)
Profile „MAster File, quality, Validation“
MAV Collector Data Manager
Validation Query[SUP-37]
Assumes: • Data Manager immediately responds with data retrieved
Can be played by any other actor
(responds synchronously)
Profile „Release Order“
Releaser Order Handler
Release Query[SUP-39]
Assumes: • Releaser manages no,one or many pending order requests• Releaser uses internal identifier for pending/released orders
Can be played by Order Placer, Order Filler, Resupply
Release Notification[SUP-40]
Sequence Diagram:Clinical Order
Order Placer Item Checker Order Responder
Order Reviewer
Check Item
New OrderReview Order
Order DetailsOrder Status