Topic 5: the Importance of Data Quality

The importance of data quality

Tania Snioch, Director Healthcare GS1 October 2018 Topics

• Data Quality

• Managing master data

• Global Location Numbers

• Trusted Data

Every company has a database filled with master data about the products they make, sell, or buy

But when one company changes any bit of information in their database or adds a new item, another database becomes outdated!

• Systems have evolved in “silos” over the last 40 years 1970s • The link between “process” and data was broken (remains so in many cases) • Numerous efforts to “unify” data and process, or views of data – one use at a time 1990s • So what? Business success still happened anyway… (and hospitals operated) • Only when costs increase, profits fall, (or a patient is negatively affected) does the real impact of bad data 2000s become known!

Original source: Gartner

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Multiple Net Weight UOMLanguage CodeCluster Package Type Net Weight(HCT/P) Register with GS1 Storage and Handling Unit of Measure" Sub-DepartmentShipping UnitOrdering Unit Net Content 2 UOM Device Count Product Size Model Number Combination Product Catalog Number Customer Contact Phone Net Content 2 Storage and Handling Low Value Material Group Packaging Material Code Business Unit Deposit UPC Fineline H Device Count Net Content 4 UOMStorage and Handling Unit of Storage and Handling High Value"i Net Content Size Value Height MeasureUOMDevice labeled as "Not made with Virtual UPC Code RFID Tagged Item Identifier Primary DI Number RPPC Indicatornatural rubber latex" Recyclable Package Storage and Handling Low Value Multi-Pack Indicator Commercial Selling UOM Package Marked ReturnableLabeler DUNS Number Package Net Content 5 Distribution Type Min Order Qty Graphics Specialty Storage and Handling Unit of StatusGraphics Specialty Base Storage and Handling Unit of Company Name Measure Composite Wood Level Code Spec Weight Supplier Number CPSCMeasure" Regulated Indicator FDA Preferred Term Code WidthExpiration Date Secondary DI Number Depth UOM Unit of Use DI Number Sub-Type Cluster Material Storage and Handling High Storage and Handling Type Base Unit GTIN GPC Coupon Family Code Large Product Description CAW Product ClassificationEnvironmental Identifier Customer Contact Email Value Storage and Handling Unit of Net Content 3 MFG Code Trademark Family Registration Status Base Unit UOM ClusterMeasure Marketing Wrap Storage and Handling TypeStorage and Handling Unit of Item Scannable Storage and Handling Unit of Invoice Item Information ProviderMeasure Tare Weight Consumer Unit Container Specialty Version or Model Number Vending Device Packaged as Measure DM DI Different from Primary DI Manufacturing Date Kit Size Text Valid From Secondary Information Provider Variable Weight Product Sub-Group Net Content 4 DepositSterile Text Item Contains WoodStorage and Package Name 1 Ordering UOM Product Code Name MFG GLN 2 Contains DI Package For Single-Use Commercial Distribution End Date Private Label IndicatorVolumeHandling Low Third Information(mm/dd/yyyy) Providerv Information Private Value Storage and Handling Low Value FDA Premarket Submission Number Register with DataPool CountryStorage of Origin and Handling High Sterilization Method Deposit Deposit Code Net Content 1 UOM Aerosol Indicator DM DI Number NationallyValue Priced SAP Description Packaging TypeAmountAudit Date Segregation Code Storage and Handling Type Storage and Handling Unit of Barcode DerivableMaterial Code Agency DI Record Publish Date (mm/dd/yyyy) Secondary DI Issuing Agency Measure Pesticide Indicator National Account Package Code Size Type Lot or Batch Number Donation Identification Number Storage and Handling Low Value Health Category Requires Sterilization Prior to Use Special Order Available Storage and Handling Type Base Unit Retail Deposit Currency Subject to US PatentLowest Level Width Deposit State Pallet Stack Height Fourth Information ProviderUOM

Product catalogues - current situation:

• Varying methods of communicating new items - Supplier A – printed catalog - Supplier B – price quote - Supplier C – PDF data - Supplier D – Excel tables - Supplier E – text data - Supplier F – link to website

• Varying methods of communicating updates/changes (or not communicating) • Varying descriptions and levels of detail (product attributes) • Varying levels of data accuracy and data quality

Hospitals need single and integrated system of exchange of information on devices and adequately identified medical devices distribution and use

• U.S. Department of Defence* discovered that : - product catalogues had problems matching the correct manufacturer name for 30% of the medical devices and 20-25% lack the product brand name - the part number ‘8630’ in the product catalogue of a leading GPO was linked to 9 different numbers from different distributors

• “Different manufacturers use different standards in different ways if they use anything at all. Distributors apply their own. Hospitals apply their own. And we just sort of cascade into this series of events which means that we can’t find devices.”

Jay Crowley, US FDA, FDA UDI Public Workshop, Feb. 2009

• In the US from 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year.

Regulators need to be able to ensure highest levels of market surveillance, to efficiently mange adverse event reports and to quickly recall devices … not only in their country but also across borders

* Source: US DoD Study The Challenge – for manufacturers

Where do we start???

The primary objective is for the hospitals, and other data recipients, to transact with GS1 Keys and integrate data into internal systems

• In order for the hospitals to do so, the following conditions must exist: • Must trust the quality of the data • Verification & integrity of data chain of custody • Must use the data as provided by the Source without altering it • Have the ability to store identifiers and supporting data • Internal systems must be capable of supporting GS1 standards • Procedures and pathways must be updated to include the relevance of GS1 standards, • Hospital processes such as procurement, logistics, warehousing, clinical, pharmacy and operating theatres need to be updated • Establish MDM & Governance processes within the hospital system, including executive sponsorship, roles and responsibilities

…in order for them to trust & use the data

• Greater efficiencies

• Lower costs

• Improved patient outcomes

Data fit for the intended purpose Country Specific (i.e. UDI-Ds)

Use Cases and Applications Hospital Hospital Logistics Pharmacy Processes Traceability Procurement UDI databases UDI

Data Sharing Services (SPs) Data Quality Master Data Services Certification Validation & Brand Owner Certification Verification

Mission: Improve the quality and availability of master data throughout the entire supply chain and data chain of custody to improve and increase it’s consumption throughout the entire value chain, including regulation.

Inconsistent, incomplete and incorrect data increases the risk of patient safety errors and the cost of healthcare across the entire supply chain. Quality data means: • Reduced rework caused by data correction and need for internal audits • Improved care by ensuring data accuracy at the point of care • Consistent use of data attributes across all stakeholders

All actors in the information supply chain have a critical role in maintaining a high level of data quality throughout the information lifecycle. The ultimate goal is for the data recipient to trust the data and thereby integrate it into their processes.

Note: Leverage as much as possible existing GS1 data quality programmes and guidelines

Solution & Service GS1 Data Sharing Data Recipients Manufacturer / Brand Owner Distributor / Wholesaler (Hospital, Regulator & Providers Infrastructure Patient)

Data Quality Data Data Quality Control Verification at the Source Quality Services Data Sharing Access to Trusted Control Proper Master Data Data Management & Governance, Master data is securely An enterprise- Certified Master Data Proper Master Data Roles & Responsibilities, shared via Brand Owner wide Services offer Data must be trusted in Management & Policies and procedures authorised data sharing information additional data order for it to be Governance, Roles services such as the lifecycle Enterprise-wide information verification, images and consumed & Responsibilities, GDSN and other management lifecycle management process other value added Surety at the point of Policies and mechanisms procedures are process ensures the data is fit for the services use assures the end assured ensures the intended purpose user that deliberate data is fit for steps have been taken the intended throughout the purpose information supply chain to ensure data quality • Identify and integrity • Mark / Barcode • Manage the Data

1. Create, Import or Receive Create - Collect, Create, Receive & Capture Import Receive 2. Enrich/Validate - Data Quality Purge Enrich 3. Sync/Activate - Push to users 4. Audit/Evaluate - Routine Monitoring Archi Sync 5. Update/Maintain ve - Maintain, Protect & Preserve 6. Inactivate/Archive - Remove from active use Update Audit 7. Purge - Delete from system

© GS1 2018 17 Use Cases: Understanding the intended end use of the data 1. Data submission to regulatory databases (i.e. UDI and IDMP) 2. Information needed for clinical decision making and patient treatment pathways 3. Product data for patient usage 4. Procurement

5. Logistics Data quality is the result of deliberate actions taken which 6. Drug identification and traceability ensure the data is fit for the intended purpose 7. Outcomes and pharmacovigilance

Supplier = data source Hospital = data Needs single point-of-entry recipient •One database to load new item data Needs single point-of- and update data on existing items truth Needs security •One source for up-to-date, accurate data •Authorisation access by supply •Continuous synchronisation chain partners Standards-based Standards-based • Standard identification keys •Standard identification keys • Consistently formatted •Predefined (set of) product information attributes • Complete information

1. Find a standards based solution which can scale as the demand for data increases (i.e. GDSN and certified Data Pools) 2. Find a technology partner that can connect you globally In 3. Define ALL regulatory and commercial attributes (Super Spec) UScountry Providers Providers

Distributor GPOss Super Wholesaler Spec Providers Global Lableler Data Pool inProviders other countries

UDI Data Submission

UDI Submission Future UDI USFDA FDA databases Acknowledgement GUDID Databasesin other countries

Distributor / Wholesaler

Manufacturer

Other Databases

Data Governance

Roles and The quality of Responsibilities the data is reflection on Enterprise wide the quality of Data Management the product Data Quality

• SAINT JOHN'S QUEENS HOSPITAL • 1100004570208

• ST JOHN'S QUEENS HOSPITAL • 100084547

• SAINT JOHNS QUEENS HOSPITAL • JAOE

• SAINT JOHN'S QUEEN HOSPITAL • 50003000431

• SAINT JOHN'S QUEEN’S HOSPITAL Many different names • CA2053 different location • ST. JOHN'S QUEENS HOSPITAL numbers for 1 hospital • OM 12345

300 different names for the same supplier

• A global standard for identification of legal entities and physical locations • A GLN is an identification Key

Different locations in a hospital

• Vital for GS1 eCom messaging so that all parties and locations may be uniquely identified • A pre-requisite for Global Data Synchronisation

• Standardising product data, enables physicians to more easily analyse and compare results from products used • Applying unique GS1 identifiers or UDIs Safer and better treatments enables more efficient recalls and verification of legitimacy of products

• eHealth  combining the best product information with the best patient information

Traceability

• Global Location Numbers (GLNs), GS1 EDI, and the unique Global Trade Item Number (GTIN) to identify products supports a fully automated order-to-cash process Seamless order to cash

• Accurate product data (weight, dimensions and packaging) exchanged through GS1 Global Data Synchronisation Network saves valuable space

Warehouse management

• Publishing product catalogues only once in the GS1 Global Data Synchronisation Network (GDSN) instead of using multiple formats, improves accuracy of data and collaboration Seamless order to cash With clinical time back to patient care!

Reduction of human intervention ($52,000/year) Warehouse management

http://www.gs1.org/healthcare/share-data

And accurate, complete, trusted data is needed through the whole chain so that every barcode scanned looks up an accurate database

Tania Snioch GS1 Global Office, Brussels E [email protected] W www.gs1.org/healthcare