Clinical Integration Track: It s All About the Data

Transcription

1 Clinical Integration Track: It s All About the Data Presenters: Sandi Michel, Director of Systems & Quality The Office of Data Standards & Interoperability Franciscan Missionaries of Our Lady Health System Kelly Nelson, Officer, Supply Chain Hospitals and Logistics Avera Health

2 FACULTY DISCLOSURE The faculty reported the following financial relationships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CE activity: - Speaker 1: Sandi Michel Nothing to Disclose - Speaker 2: Kelly Nelson Nothing to Disclose

3 Experts estimate that spending on healthcare IoT (Internet of Things/i.e., data) could top $120 billion in the next four years. Big Data has changed the way healthcare providers manage, analyze and leverage data. Obtaining and maintaining accurate, high-quality data is vital for it to be usable and valuable for your organization. This session will provide an overview of opportunities to better understand and to seize the full potential of data. Discover how to develop realistic data strategies, implement data management discipline, and start asking better questions.

4 The FDA plans to update its Global Unique Device Identification Database (GUDID) this year to include new file data elements, record accessibility and premarket submission and supplement number requirements. The presenter in Part 1 of this session will share information needed to implement and use UDI successfully and will address the challenges that UDI implementation presents. Emphasis will include key components of the requirements of the UDI regulations, best practices for collaboration between providers and their supply chain partners, and insights on making UDI work to your advantage.

5 Driving effective collaboration and communication with vendors can enable cost reduction, risk mitigation, and innovation. This collaboration is improved when the data related to products and services is accurate and consistent. Part 2 of this session will focus on the critical importance of including data controls into your supply chain workflows. You will gain an increased understanding of how to turn your suppliers into your strategic partners through better communication regarding data, its availability and its accuracy.

6 Learning Objectives: 1. Describe the new UDI requirements that will become effective in Detail three ways to better manage data in your organization. 3. Formulate strategies to facilitate better exchange of data with suppliers

7 Part 1: Opportunities to better understand and seize the full potential of data Sandi Michel, Director of Systems & Quality The Office of Data Standards & Interoperability Franciscan Missionaries of Our Lady Health System

8 New UDI requirements that will become effective in 2018

9 COMPLIANCE DATE MUST BEAR AN UDI AND SUBMIT DATA TO THE GUDID DIIRECT MARKING FOR CERTAIN INTENDED USES SEPTEMBER 24, 2014 CLASS III DEVICES DEVICES LICENSED UNDER THE PHS ACT SEPTEMBER 24, 2015 IMPLANTABLE, LIFE-SUPPORTING AND LIFE- SUSTAINING (I,LS,LS) DEVICES LS,LS DEVICES SEPTEMBER 24, 2016 CLASS II DEVICES CLASS III DEVICES AND DEVICES LICENSED UNDER THE PHS ACT SEPTEMBER 24, 2018 CLASS I DEVICES AND UNCLASSIFIED DEVICES CLASS II DEVICES SEPTEMBER 24, 2020 Extended by Enforcement Discretion Guidance CLASS I DEVICES AND UNCLASSIFIED DEVICES

10 Consistent with 21 CFR (a)(1), finished class I and unclassified devices manufactured and labeled before September 24, 2018, are excepted from the UDI labeling and GUDID submission requirements by regulation until September 24, 2021.* Type of Device Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018 FDA does not intend to enforce UDI labeling (21 CFR & ), GUDID Data Submission (21 CFR ), and Standard Date Format (21 CFR ) requirements before: FDA does not intend to enforce Direct Mark requirements (21 CFR ) before: September 24, 2020 September 24, 2022 September 24, 2021* September 24, dancedocuments/ucm pdf *

11 Benefits of UDI Helps providers identify patients implanted with recalled products using a standardized identifier Enables patients and providers to submit more precise adverse event reports Supports care coordination by providing physicians with precise information on the devices implanted in patients Allows hospitals to perform analyses comparing devices used in that facility Allows providers to submit information to device registries Provides a foundation to address counterfeiting of products Source: n/benefitsofaudisystem/default.html

12 Implement and Use UDI Successfully The FDA requires manufacturers to mark their device/implant products with a Unique Device Identifier (UDI) and register each Class III and Class II device in the GUDID Download the data from the GUDID to ensure accuracy in your ERP and EHR The Device Information (DI) can be stored in your EHR for matching at the Point of Use Scanning in the Operating Room saves time and improves accuracy; many products have barcodes containing the DI and Production Information (PI) that makes up the full UDI Leveraging the UDI to Capture, Store, Transmit and Retrieve data ensures you have the right device for locating the item, notifying physicians and patients about recalls, and reporting adverse events. Beyond these functions, we envision UDI transmitting into claims and registries.

13 Challenges that UDI implementation presents Not all Manufacturers are in compliance with the FDA and ONC HIT requirements Most, but not all devices have a barcode that contains the full UDI; some may have the DI but not the PI in a barcode Tissue does not always have a barcode Some wrappers on devices do not scan due to reflective silver, shiny materials Our EHR has two tabs, one for Supplies and one for Devices; Nurses must be diligent to open the right tab to enter device information into the Implant tab to be prompted for required PI information Some wrappers have multiple barcodes from multiple standards organizations; therefore, the nurse doesn t know which one to scan. Some wrappers have a linear barcode and a 2D barcode; the 2D barcode usually contains more information

14 Best practices for collaboration between providers and their supply chain partners First and foremost, our device suppliers are truly our supply chain partners and together, we implemented UDI at FMOLHS; communication is the key. Our 3 rd party Software Providers are truly our valued IT partners and together, we implemented UDI at FMOLHS Interoperably. Our manufacturers send their data to the GDSN and the GUDID; our Data Pool pulls in the information, synchronizes the data and sends it to our FSEnet portal. At this point, we know the data is as accurate as our source of truth -the manufacturer. The data is sent through an interface into our virtual item master and onward to our EHR and other systems. We retrieve the data through reports for various analytics and validation for compliance. FDA, ONC HIT and Joint Commission have one place to go to see where UDI is tracked in our Champion UDITracker

15 Three ways to better manage data in your organization

16 1. Using Data Standards to better manage data in your organization FDA Accredited Issuing Agencies GS1 HIBCC ICCBBA UPC The Transactional Supply Chain Item master as the source of truth, (ERP, Virtual Item Master, or the Manufacturer) Ensuring chain of custody/eliminating counterfeiting eventual downstream to claims and registries UDI Adoption Clinicians, supply chain, HealthIT

17 2. Standardize like items by weighing Cost, Quality and Outcomes Resource Utilization and Value Analysis Teams compare like items, with the Patient, the Health System and the Physician in mind New Products Process Engaged Physicians Using reports and analytics from the to seize the full potential of the data Surgery Cost per Case per Physician per Procedure per Implant or Supply, and OR Time Comparing Outcomes, Readmissions, Implant extracts Use LEAN Methodologies to redesign outdated processes and policies Admissions Scheduling Staff, Patients, Physicians, OR and Procedure Rooms, Labs, Imaging, etc. Length of Stay, Pre-op clearance, Hospital Medicine, Staff Satisfaction, Patient Satisfaction

18 3. Using Interoperability with systems and apps, Hosted and non-hosted 3 rd party software and interfaces Make the Source of Truth part of your data strategy Manufacturer Data (Direct from the Manufacturer) GDSN (GS1) GUDID (FDA) Synchronize the data Passing data electronically through interfaces and dedicated field mapping, identifying errors, and communicating back to the source Use Hosted solutions to free up resources where it makes sense Adverse Event Reporting, Recalls, Devices/Implants Track & Trace, Data Pool, Warranty and Rebate Management

19 The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). The FDA is establishing the unique device identification system to adequately identify devices sold in the U.S.- from manufacturing through distribution to patient use. You can use AccessGUDID to search for specific medical devices or download all the GUDID data at once. AccessGUDID also offers RSS feeds and APIs to connect you directly to the data.

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25 References Unique Device Identification-UDI UDI Basics s/default.htm AccessGUDID (for the public) DIDatabaseGUDID/ucm htm UDI Resources betweenudiproposedandfinalrules/default.htm SMI Report: Introducing UDI Labeling Strategies into the Surgical Setting or Unique Device Identifiers (UDIs): A Roadmap for Effective Implementation. Engelberg Center for Health Care Reform at Brookings. December Unique Device Identifier (UDI). AdvaMed. Learning UDI Community (LUC):

26 Driving effective collaboration

27 Agenda: Who is Avera Why are data controls important How to leverage your data Driving collaboration

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29 About Avera Avera is a Health Ministry sponsored by the Presentation and Benedictine Sisters of South Dakota Avera serves a population of nearly 1 million throughout a geographical footprint of 72,000 square miles and 86 counties. Avera serves patients in 330 locations and is the largest employer in the State of South Dakota Avera ecare is the largest telemedicine provider in the United States

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32 Who Drives Health Care Expense Source: Epidemic of Care, by George Halvorson and George Isham,, MD.

33 Why are data controls important? Patient Safety Total cost of care Pricing accuracy Contract compliance Utilization Review

34 Why does healthcare struggle so much with data? Not one source of truth Common disconnect between patient/charge cost and cost of acquisition Vendor data and provider data timing issues Vendor Consolidation and changes

35 Validating vendor data to provider data

36 Item master vs. Charge master: Making it a 1:1 grouping vs. 1:many Item master living in EMR Know your limitations or opportunities

37 Supply Chain Revenue Cycle Integration Review New Items for reimbursement opportunities and chargeability before procurement Ensure the chargeable item is assigned a charge code and the correct HCPCS and charge code exist on the supply, in the item master Maintain charge information on the item in the item master Report major pricing changes, new contracted items and pricing, to finance key contacts for review and analysis

38 Where are we headed? Supply Chain Item Master Standardization One to One Supply Charge Structure Standard Supply Charge Methodology Routine Non-Routine Centralized supply charge request workflow Price Modeling

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40 Know your limitations Know what your opportunities are Make plans to mitigate the limitations Build on what works Leverage that data that you have

41 Example 1 Fairview Dashboard

42 Example 2 Avera Surgery Supply Cost

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48 How to identify a good partner: TRUST Leadership engagement Willingness to build it TOGETHER Being ok with the unknown Teamwork Understanding that Failure IS an option Sense of Urgency

49 Case Study # 1 What we did when I was at Fairview Entered a risk share contract around Med/Surg Products : 335 products $1.180 million in spend Operationally we do not pay for these items on a traditional as used basis rather a monthly cap amount.

50 Contract categories include: General wound care OR accessories OB accessories Neonatal Incontinence Electrodes Feeding

51 Goals: Tie use of core products to an activity indicator Shift focus from selling products to promoting appropriate use. Shared benefits for Fairview (overall cost reduction) and Vendor partner (increased profitability)

52 Case Study # 2 What we are doing at Avera Entering into several strategic partnerships Contractual contracts for longer terms (5-7 years ) Sole sourced in at least one area Engage Senior leadership in both parties to drive direction on the relationship and strategic growth

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54 Find a willing partner DO SOMETHING Measure success or failure

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