143: Standards in your Healthcare ERP System

143: Standards in your Healthcare ERP System Keith Lohkamp, Infor Lawson Kevin Capatch, Geisinger Health System Topics Introductions Challenges and the Case for Healthcare Impacts of GS1 on Healthcare ERP Systems Case Study: Infor Lawson Supply Chain Management Geisinger Health System Wrap-up and Q&A 2 1

Today s Presenters Keith Lohkamp, Product Director, Infor Lawson Supply Chain 17 Years in Healthcare and Software Product Management Set strategy for Infor Lawson s Healthcare Supply Chain Portfolio Helped to bring to market multiple new applications including Recall Management, Analytics, Mobile Supply Chain Management, Strategic Sourcing, Contract Management, and Point of Use. Currently represents solutions providers on the GS1 Healthcare US Leadership Team and the Strategic Marketplace Initiative board. Kevin Capatch, Director of Supply Chain Technology and Process Engineering at Geisinger Health System (GHS) in Danville, PA In his current role, Kevin is responsible for oversight of supply chain information systems, technology and operational improvement efforts. In addition to his 5 years at GHS, he has over 25 years of experience in electronics, medical device, and contract manufacturing He utilizes Lean Thinking to focus on magnifying the value and eliminating the waste in the core value streams. He is co-chair of GDSN, GS1 CAB, and founding member of the HTG 3 Challenges and the Case for Healthcare 4 2

Challenges in the Healthcare Supply Chain Inefficiency and error in procurement process and recall management Lack of optimal integration between external and internal supply chain Lack of optimal integration between supply ppy chain and clinical care in hospital systems Lots of causes Silo d mentality Proprietary data and product ID Manual processes Not maximizing use of technology Perfect Order and Beyond. http://www.prnewswire.com/news-releases/mercyroi-and-bd-collaborate-to-improve-quality-of-care-andreduce-costs-137718398.html 5 Regulatory Background FDA Amendments Act of 2007, FDA Safety and Innovation Act (2012) Not later than December 31, 2012, the Secretary shall issue proposed regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number. The Secretary shall finalize the proposed regulations not later than 6 months after the close of the comment period and shall implement the final regulations with respect to devices that are implantable, life-saving, and life sustaining not later than 2 years after the regulations are finalized, taking into account patient access to medical devices and therapies. U.S. FDA Regulatory Information. http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/foodanddrugadmi nistrationamendmentsactof2007/default.htm U.S. FDA Medical Devices http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/ucm310927.htm 6 3

FDA s Proposed UDI Rule Released July 3, 2012, public comment through Nov 7, 2012 Intent to substantially reduce existing obstacles to the adequate identification of medical devices used in the United States Public health objectives: Reduce medical error Simplify device info in data systems More rapid ID of medical devices with adverse events More rapid solutions to reported adverse events More rapid and efficient device recalls Better FDA communication Easily-accessible source of device info Regulations.gov. Unique Device identification System. http://www.regulations.gov/#!documentdetail;d=fda-2011-n- 0090-0001 7 FDA s Proposed UDI Rule UDI on label and packaging of medical devices Device Identifier manufacturer and model Production Identifier lot#, serial#, expiration date or date of manufacture Plain text form and through auto ID and capture technology (AIDC) Submission of info to FDA publicly-accessible database, the Global Unique Device Identification Database (GUDID) All UDIs issued by FDA-accredited issuing agencies Direct Part Marking on implantable devices, devices intended for greater than one use with sterilization Number of exceptions OTC devices Class I single use devices distributed in package Exported devices Production identifier on Class I 8 4

FDA s Proposed UDI Rule GUDID Device identifier Brand name Model # If labeled sterile If labeled as containing latex Size Type of production identifiers on label FDA premarket submission number FDA listing number GMDN code for device # devices/device package Labeler contact info Regulations.gov. Unique Device identification System. http://www.regulations.gov/#!documentdetail;d=fda- 2011-N-0090-0001 3 FDA s Proposed UDI Rule Timeline Implantable Life-Sustaining Life-Supporting CLASS III CLASS II CLASS I UDI on Label/Package 1 2 2 UDI on Device 2 2 2 GUDID Submission 1 2 2 UDI on Label/Package 1 3 5 All Other Items UDI on Device 3 5 7 GUDID Submission 1 3 5 Final Rule expected in June-ish 2013 Amended rule: https://www.federalregister.gov/articles/2012/11/19/2012-28015/unique-device-identification-system Regulations.gov. Unique Device identification System. http://www.regulations.gov/#!documentdetail;d=fda-2011-n-0090-0001 10 5

UDI Regulations Drive Need for GS1 Standards Manufacturers will assign a unique identifier like a GTIN to each product at each level of packaging. For most products, manufacturers will also provide secondary production identifiers Exp. Date Serial # Lot This information will be on barcodes 11 Supply Chain Impacts on Hospitals Greater accuracy in supply chain processes Cleaner data Reduce exceptions and rework More efficient internal and trading partner relationships Potential cost savings Fewer expired products Improved management of recalls Enhanced data capture Unique identifier for integration across hospital systems Standard to document devices in patient care setting 12 6

ERP in Healthcare 13 What is Enterprise Resource Planning? Enterprise resource planning (ERP) is an application strategy focused on several distinct enterprise application suite markets. In general, ERP involves software packages that automate and support the processes of the administrative, production, inventory and product development aspects of an enterprise. ERP is considered the back-office application set and encompasses applications that enable manufacturing, human capital management (HCM), financial management systems (FMS) and enterprise asset management (EAM). (Source: Gartner Dataquest) Can include: Supply Chain Management (SCM) Materials Management Information Systems (MMIS) Supplier Relationship Management (SRM) E-Procurement Customer Relationship Management (CRM) 14 7

ERP / MMIS Crucial for Implementing GS1 Top ERP / MMIS vendors have declared support 15 GS1 Impacts on Healthcare ERP 16 8

GS1 Standards Used Across Multiple Processes GLN Identifying locations Contract eligibility Rostering Rebates / chargebacks Electronic business transactions Purchase Orders Confirmations / Acknowledgements Advanced Shipment Notices Invoices Sales Tracing GTIN Identifying products Pricing Rebates / chargebacks Electronic business transactions Purchase Orders Confirmations / Acknowledgements Advanced Shipment Notices Invoices Sales Tracing Recall processes 17 GLNs are used for Identifying locations Contract eligibility Rostering Rebates / chargebacks Electronic business transactions Purchase Orders Confirmations / Acknowledgements Advanced Shipment Notices Invoices Sales Tracing 18 9

GLNs and Procure to Pay Replace custom identifiers with GLNs in processes for both paper documents (Purchase Orders, Advance Ship Notices, etc), and EDI transactions First priority, scalable and repeatable: 850 Purchase Order (PO) 855 Reply to Purchase Order 860 PO Change Request 856 Advanced Ship Notice Later in process: 810 Invoice 844 Rebate Request GLN training for customer service and procurement personnel. 19 How are GTINs Used? Placed on trade items as bar codes Shared with trading partners using the GDSN Used to identify trade items in electronic business transactions (e.g., purchase order, invoice, ASN) Used instead of SKUs, part numbers, catalog numbers, etc. between trading partners in business processes 20 10

Application of GTIN Assigned to healthcare products. GTIN is assigned by brand owners to every level of product. Used in business transactions (either paper p or electronic). Standard number used between two entities to identify a product. Marked on appropriate packaging levels. GTIN is encoded in Barcode/RFID tag on every appropriate level of packaging sold/distributed commercially and found in a database. Scanned at points-of-delivery to enhance clinical process. Scan barcodes/rfid: at receiving dock, central supply, points-ofcare. Used in product returns and recalls. GTIN would be one of the mandatory elements Included with the product description to further assist a recall. Registered in a GS1 GDSN-certified Data Pool. GTINs and associated product data to be validated/verified, maintained, stored, and shared in a GDSN-certified Data Pool 21 21 Secondary Information and Barcodes In addition to the primary information (GTIN), secondary information can also be represented in the GS1 System of Standards. Examples Lot Number Expiration Date Serial Number This information is referred to as Application Identifiers (AIs) in the GS1 System of standards. GTIN (Global Trade Item Number) Expiry Date Lot Number Serial Number 22 22 11

GTIN Impacts on Hospital ERP / MMIS Track Tie GTIN and attributes to item master at every level of packaging Track lot/serial with inventory Transact Order Manage inventory Scan barcodes Interface Inbound from GDSN, manufacturers, UDID or other data sources Outbound to clinical systems Outbound to other supply chain systems Report Spend and utilization Inventory Recalls 23 Barcode Scanner Compatibility GS1 recommends image scanners Read linear and two dimensional barcodes Barcode Scanner Quality Measures Security of wireless communications Usability/Human Technology Interface Ease of Set-up Symbologies Readability Battery Maintenance Customer Service Record/Reputation User Satisfaction Ratings 24 24 12

Applications of GTIN Beyond the Supply Chain Adverse event reports Link EHR and claims data Device identification in clinical registries Link FDA databases, premarket and postmarket Recall management 25 Strategy Considerations Related to GLN & GTIN Data management Who owns maintaining your GLNs? What is your strategy for sourcing and managing g product information? Who is responsible for managing? How do you get or keep your data clean? Data capture Will you get data from 3 rd party source? Will you use ASN from suppliers? Will you use automated data capture? Processes Which processes will incorporate? What data will you track and use? How will you share? 26 13

Sharing Data in Healthcare The GS1 Global Data Synchronization Network (GDSN ) is an automated, standards-based global environment that enables secure and continuous data synchronization, allowing all trading partners to have consistent item data in their systems at the same time. The GS1 GDSN connects customers and suppliers, via their selected certified Data Pools, to the GS1 Global l Registry. Healthcare focused examples include GHX HealthConnexion and 1WorldSync 27 27 GDSN Functionality 28 14

Attributes to Capture & Store GDSN Mandatory, Healthcare Mandatory Global Trade Item Number Numbering structures will be considered as 14-digit Global Trade Item Number (GTIN). Must be present to enable data to be presented to trade item catalogue. Must be submitted by the owner of the data (who may be the original manufacturer, the importer, the broker or the agent of the original manufacturer). Trade Item Describes the hierarchical level of the trade item. Unit Descriptor Name Of Information Provider Information Provider Of Trade Item Name of the party who owns the data. Name of the information provider on the trade item. The data owner is not necessarily the source of the data, but has the responsibility to provide and maintain the data in the catalogue. Target Market Country Code Brand Name Classification Category Code Is Trade Item An Orderable Unit Is Trade Item A Base Unit Follows AIDC guidelines. This information drives data synchronization rules linked to global/local, local status. The recognizable name used by a brand owner to uniquely identify a line of trade item or services. This is recognizable by the consumer. Global EAN.UCC classification category code. Unique, permanent 10-digit key. An indicator identifying that the information provider considers this trade item to be at a hierarchy level where they will accept orders from customers. This may be different from what the information provider identifies as a dispatch unit. This may be a relationship dependent based on channel of trade or other point to point agreement. An indicator identifying the trade item as the base unit level of the trade item hierarchy. 29 29 Attributes to Capture & Store GDSN Optional, Healthcare Recommended Additional Trade Item Identification Parent GTIN Child GTIN Manufacturer Additional Trade Item Description Net Content + UOM Qty of Next Lower Level Trade Item Trade Item Label Indicates Latex Type of the identification system that is being used as an alternative to the Global Trade Item Number. A particular Global Trade Item Number, a numerical value used to uniquely identify a trade item. In this context, the GTIN for the parent item of the current item. A particular Global trade item Number, a numerical value used to uniquely identify a trade item. In this context, the GTIN for the current item which is a child item of another item. Descriptive name or GLN of the manufacturer of the trade item. Additional variants necessary to communicate to the industry to help define the product. Multiple variants can be established for each GTIN. This is a repeatable field, e.g. Style, Color, and Fragrance. The amount of the trade item contained by a package, usually as claimed on the label. In case of multi pack, indicates the net content of the total tradeitem. This represents the Total quantity of next lower level trade items, or Children GTINs, that this trade item contains. An indication that a trade item label indicates that the item is made from or contains latex which refers generically to a stable dispersion (emulsion) of polymer microparticles in an aqueous medium. 30 30 15

Attributes to Capture & Store GDSN Mandatory, Healthcare optional can be defaulted Functional Name Describes use of the product or service by the consumer. Should help clarify the product classification associated with the GTIN. Default Height + UoM The measurement of the height of the trade item. 0.001 Width + UoM The measurement from left to right of the trade item. 0.001 Depth + UoM The measurement from front to back of the trade item. 0.001 Is Trade Item A Consumer Unit Is Trade Item An Invoice Unit Is Trade Item A Dispatch Unit Is Trade Item A Variable Unit Is Packaging Marked Returnable ProductRange Identifies whether the current hierarchy level of a trade item is intended for ultimate consumption. False An indicator identifying that the information provider will include this trade item on their billing or invoice. False An indicator identifying that the information provider considers the trade item as a dispatch (shipping) unit. False Indicates that an article is not a fixed quantity, but that the quantity is variable. Can be weight, length, volume. False Trade item has returnable packaging. False This optional attribute is to be populated with the value of "INDICATORS DEFAULTED" should the values for istradeitemaconsumerunit, istradeitemaninvoiceunit, istradeitemadespatchunit, istradeitemavariableunit, and ispackagingmarkedreturnable be default GDSN & Healthcare Optional attributes exist as well. For greater detail, see the GS1US.org/healthcare website 31 31 Sample Purchase Order with GS1 Use Bill to GLN: 1100005961821 Use Ship to GLN: 1100005961758 UOM not necessary due to GTIN Replace with GTIN: 10326053100014 LIN*001*UK*10326053100014 N1^ST^<St. Johns>^UL^<1100005961758> N1^BT^<St. Johns>^UL^<1100005961821> 32 16

Case Study: How Infor Lawson Supports Standards 33 Infor Snapshot Lawson acquired in 2011 $2.8b 5straight total revenue quarters of double digit license growth 3rd 9,000 13,000 largest enterprise applications company engineers & technical consultants employees 17

Specialized by industry 19 of the top 20 aerospace companies 82 of the top 100 automotive suppliers 9 of the top 10 pharmaceutica l companies 26 of the top 50 industrial distributors 4,700+ machinery manufacturers 26 of the 35 largest global retailers 6 of the top 10 brewers 19 of the top 20 U.S. hospitals 12 of the top 13 high tech companies 90% of the Las Vegas Strip More than 5,500 industrial manufacturing customers 1,100+ state and local governments 3000+ Healthcare Customers 18

Impacts on Infor SCM for Healthcare Track Transact Interface Report Setup GLN for locations, vendors and manufacturers Contract eligibility Tie GTIN and attributes to item master Track lot/serial with inventory Order Manage inventory Scan barcodes Inbound from GDSN, manufacturers, or other data sources Outbound to clinical systems Outbound to other supply chain systems Spend and utilization Inventory Recalls Tracing 37 19

End-to-End Healthcare Supply Chain SOURCE MOVE PURCHASE MAINTAIN CONSUME Source Contract Monitor Engage Recall Analyze Schedule Receive Deliver Cross-dock Transport Pick & pack Ship Analyze Inventory Purchase Match Reconcile Order Monitor Analyze Maintenance Energy Risk Reliability Change management Compliance Request Punchout Issue Count Capture Approve Integrate Analyze Compliance Integrate Infor Lawson is ready for GS1 Current releases support GS1 Standards Store, Search, Transact using GLNs / GTINs, including via EDI Load, Store and Use GDSN attributes Configure individual trading partners for use of GS1 Standards Scan manufacturer barcodes in MSCM and Point of Use Supported in Financials, Procurement, Strategic Sourcing, Contract Management, Requisition Center, MSCM, Point of Use, EDI, and Analytics. Benefits: Help healthcare supply chain move from custom account, item and product identifiers to standardized information, reducing errors, streamlining processes and enhancing patient safety. 40 20

Approach to GLN within Infor Lawson Assigned to: Requisition Locations Ship To Locations Company Vendor Vendor Purchase From Manufacturer GLN Hierarchies tracked Displays in multiple locations Available in most transactions including PO and sent via EDI Natively or via Data Substitution Option to use GLN or not 41 Approach to GTIN within Infor Lawson Set up within Inventory Control Assign a GTIN for each Item / UOM Captures additional attributes from GDSN Visible and available in: Requisitions Purchase Orders Receiving Issues Accounts Payable Recalls Various Interface Files Most other applications Transact / Search using GTIN EDI support Scan GTIN barcode Support for UDI GTIN + Lot/Exp. Date GTIN + Serial # 42 21

GTIN Does Not Replace ERP Identifiers 21 G x 1.25 in BD Eclipse blood collection needle with luer adapter. Lawson Item: 10024 UOM: EA UOM: SP UOM: CS Vendor (O&M) Item: 1 UOM: SP Vendor (BD) Item: 368607 UOM: CS Manufacturer Item: 368607 GTIN: 382903686070 GTIN: 50382903686075 GTIN: 30382903686071 Barcode Data Needs to be Parsed 22

Loading GDSN data Sources From the GDSN via a Certified Datapool like GHX HealthConnexion Direct from Manufacturer Via a GPO that is subscribed to GDSN How to Upload Upload via a spreadsheet or CSV file Online entry XML via ProcessFlow Integrator 45 Summary GS1 standards can impact processes across all software supply chain systems Good ERP data drives both supply chain and clinical processes Infor Lawson users have been able to implement GS1 standards since late 2009 Many of the early adopters of standards in healthcare use Lawson and many more in implementation 46 23

Case Study: Geisinger Health System KEVIN CAPATCH, DIRECTOR OF SUPPLY CHAIN TECHNOLOGY AND PROCESS ENGINEERING 47 Geisinger Heath System 5 Hospitals 6 Main Clinic/Ancillary locations 41 Community ypractice sites 44 Counties (Service area) 18,000 Employees 48 24

Patient Stats (2012): Licensed Inpatient beds EDVisits Surgerycases Discharges GMC 545 42,295 25,937 26,966 GWV 250 57,829 11,650 13,501 GCMC 297 15,097 3,109 5,176 49 Geisinger Health System coverage area Revised 6 28 12. Geisinger PR & Marketing Department 50 25

Geisinger Health System An Integrated Health Service Organization Provider Facilities Geisinger Medical Center Danville Campus includes Hospital for Advanced Medicine, Janet Weis Children s Hospital, Women s Health Pavilion, Level I Trauma Center, Ambulatory Surgery Center Geisinger Shamokin Community Hospital Geisinger-Bloomsburg Hospital Geisinger Wyoming Valley Medical Center with Heart Hospital, Henry Cancer Center, and Level II Trauma Center Geisinger South Wilkes-Barre campus with Urgent Care, Ambulatory Surgery Center and Inpatient Rehabilitation Geisinger Community Medical Center with specialized medical & surgical services, including Level II Trauma and comprehensive cardiac & orthopaedic services Marworth Alcohol & Chemical Treatment Center Mountain View Care Center Bloomsburg Health Care Center >72K admissions/obs & SORUs 1,593 licensed inpatient beds Physician Practice Group Multispecialty group ~1,000 physicians ~520 advanced practitioner FTEs 65 primary & specialty clinic sites (37 Community Practice Sites) Freestanding outpatient surgery center > 2.1 million clinic outpatient visits ~360 resident & fellow FTEs Managed Care Companies ~298,000 members (including ~63,000 Medicare Advantage members) Diversified products ~30,000 contracted providers/facilities 43 PA counties PA Medicaid initiative Out of state TPA contracts Note: Numerical references based on fiscal 2012 budget plus impact of GSACH, GCMC and GBH acquisitions. 51 Geisinger Health System and HTG In 2010, five Integrated Delivery Networks (IDN s) formed an action-oriented collaboration to share best practices and drive needed positive change across the healthcare supply chain. Our first focused initiative: Address the implementation of GS1 Standards. www.healthcaretransformationgroup.com 52 26

Common Foundation o Accelerate change across the supply chain o Enhance patient t safety o Improve supply chain efficiencies o Drive the adoption of GS1 Standards with suppliers o Communicate in the marketplace through one voice 53 Why standards are important Patient Safety Reduced Labor Inventory Management Quality Service Value Revenue Management Outcomes Analysis Transactional Processing 54 27

Information technology helps to drive the adoption of GS1 Standards throughout the supply chain and beyond. HTG sees these standards as leading practices for both business processes and patient safety. Information Technology Benefits o Ship to/deliver to/bill to locations o Product identification o Supplier ordering entities o End user satisfaction o Product scanning o Order accuracy o Invoice accuracy o Timely payments o Improved patient safety 56 28

Benefits o Synchronized data o Opening communication o Internal customers o Suppliers o Distribution o Point of Care optimization o Electronic Health Records o Product recalls o Reimbursement 57 HTG Standards Implementation o Mercy Perfect Order o Geisinger Value Stream Mapping o Kaiser Electronic Health Record Pilot o Mayo Clinic Ice Auger Project 58 29

Inside cover of Supply Chain Strategies & Solutions March/April 2013 Supply Chain Strategies & Solutions v.7 n.2 59 Implementation of GTIN 60 30

GTIN on Purchase Order Screen 61 GTIN and GLN Output on a Purchase Order 62 31

Opening Doors o FDA ruling o Vendors and software Providers are listening o Contracting is opening up to standards implementation o Product labeling 63 Conclusion 64 32

Does my system Track and store GS1 standards Store unique organization identifies based on GLN standards Store unique product identifiers based on GTIN standard Track additional unique identifiers like lot or serial Track GDSN attributes Allow you to transact using these identifiers Support automated data capture Interface using standards 65 Questions? keith.lohkamp@infor.com kjcapatch@geisinger.edu 33