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Hospital Summit. Processes and KPIs Health Care Value Chain Rafael Provencio

Hospital Summit. Processes and KPIs Health Care Value Chain Rafael Provencio. Table of contents. Regulatory Framework EU Hospital Value Chain Processes KPIs. What is the goal of the regulatory framework?.

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Hospital Summit. Processes and KPIs Health Care Value Chain Rafael Provencio

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  1. Hospital Summit. Processes and KPIsHealth Care Value ChainRafael Provencio

  2. Table of contents • Regulatory Framework EU • Hospital Value Chain • Processes • KPIs Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  3. What is the goal of the regulatory framework? • Thetarget of the regulatory framework is to keep safety and performance on Medical Devices Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  4. General Framework Directive 93/42/EEC concerning Medical Devices In vitro medical devices Directive 98/79/EC Human blood/plasma Directive 2000/70/EC Human blood/plasma Amendments Directive 2001/104/EC Regulation 1882/2003 Commitees to assist the Commision Directive 2007/47/EC Active implantable Medical Devices Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  5. General Framework • Some topics about medical device safety: • Complete safety is not achievable • It is a Risk Management issue • It is deeply linked with device performance • It must be considered through the life spam of the device • It requires shared responsibility over all parts involved Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  6. Product Safety Electromag. compliance User knowledge Ergonomic design Protection Radiation General Framework • Target of the sanitary legal environment: • Guarantee the free movement of those within the EU territory, offering, at the time, an adequate protection level so the products that circulate do not represent risks for the health or safety of the patients, users or third persons and reach the defined performance, by the manufacturer when used under the previewed conditions With this goal the essential requisites are being established so they must be fulfilled by the devices and accessories, including software Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  7. Definitions: Medical Device • “Medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: • diagnosis, prevention, monitoring • treatment or alleviation of disease • diagnosis, monitoring, treatment, alleviation of or compensation for an • injury or handicap • investigation, replacement or modification of the anatomy • physiological process • control of conception Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  8. Definitions: Accessory • Accessories are products in their own right and, although being treated as devices [they] do not follow, as general rule, the classification of related devices in conjunction with which they are used. • The question whether a product is a device or an accessory has not practical consequence. Following the article 1(1) of Directive 93/42/EEC, “accessories shall be treated as medical devices in their own right”. Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  9. Portable ECG, thermal blanket, thermal cushion, newly-born cradle, mannequin… Classification of DevicesEU & EFTA Risk Class I Non Invasive, Reusable surgical instruments, invasive <1min Annex IX of the Council Directive 93/42/EEC Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  10. Classification of DevicesEU & EFTA Risk Class IIa Blood Pressure Monitor, ECG, CPAP System, contact lenses, spirometer… Annex IX of the Council Directive 93/42/EEC Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  11. Anesthesia device, central gas station, vaporizator, respirator, bronchial aspirator, infusion pump, incubator, hyperbaric chamber, pacemaker Classification of DevicesEU & EFTA Risk Class IIb Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices Annex IX of the Council Directive 93/42/EEC Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  12. Classification of DevicesEU & EFTA Class III Connection to nervous system, heart or central regulatory Risk Annex IX of the Council Directive 93/42/EEC Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  13. Classification of DevicesEU & EFTA Class III Connection to nervous system, heart or central regulatory Risk Class IIb Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices Class IIa Invasive short term, administer or exchange energy Class I Non Invasive, Reusable surgical instruments, invasive <1min Annex IX of the Council Directive 93/42/EEC Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  14. Manufacturer Vendor At the Hospital Directive 93/42/EEC in the Device’s Life Cycle Installation Development Manufacture Packaging Labelling Sale Production Disposal Promotion Purchasing Maintenance • User trainings • Adverse events surveillance • Use the device according to the designed purpose • Ensuring that the device is performing as it was designed • Legal representative of the Manufacturer • Acquire proper knowledge • Ensure installation (Art. 2) • Post-market surveillance (Art. 10) • Essential requirements: Art. 3 • CE Marking: Art. 17 • Declaration of conformity: Art. 11 • Details of conformity assesment “The lack of, or inappropriate, calibration and maintenance can seriously jeopardize their safety and performance. These issues are often overlooked or underestimated” World Health Organization GMPs ISO standards: ISO 9001:2008 ISO 14001:2005, ISO 13485:2003 ISO 9001:2008 ISO 14001:2005 ISO 13485:2003 No homogeous situation Up to every hospital Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  15. Manufacturer Manufacturer Vendor At the Hospital No homogeous situation Up to every hospital ISO 9001:2008, ISO 14001:2005,ISO 13485:2003 Directive 93/42/EEC in the Device’s Life Cycle Installation Sale Installation Development Manufacture Packaging Labelling Sale Production Disposal Promotion Promotion Maintenance Purchasing Maintenance • User trainings • Adverse events surveillance • Ensuring that the device is performing as it was designed • Legal representative of the Manufacturer • Adquire proper knowledge • Ensure installation • Post-market surveillance • Essential requirements: Art. 3 • CE Marking: Art. 17 • Declaration of conformity: Art. 11 • Details of conformity assessment GMPs ISO standards: ISO 9001:2008 ISO 14001:2005, ISO 13485:2003 ISO 9001:2008 ISO 14001:2005 ISO 13485:2003 ISO 9001:2008, ISO 14001:2005,ISO 13485:2003 No homogeous situation Up to every hospital Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  16. Table of contents • Regulatory Framework EU • Hospital Value Chain • Processes • KPIs Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  17. What is the Value Chain? • The entire production chain from the input of raw materials to the output of final product consumed by the end user. • (M. Porter) Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  18. What is the Value Chain? • The entire production chain from the input of raw materials to the output of final product consumed by the end user. • (M. Porter) • Focus in the in the interests of the whole process • Optimize all activities from all players • Define the best relationships beween the players • Collaborative approach • Trust is Needed! Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  19. Obstacles to the Healt Care Value Chain • Paper shuffling • Lengthy product ordering and delivery cycle times • Multiple product handling activities • Excessive inventory carrying costs • Lack of information sharing among trading partners • Little information on product location and utilization • Operational focus (instead of customer focus) • Pressure to cut short-term costs • Lack of trust between partners • Lack of easy business mechanics (e-commerce) • (The Health Care Value Chain: producers, purchasers and providers • Lawton R. Burns) Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  20. Value Chain vs. Five Forces Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  21. Table of contents • Regulatory Framework EU • Hospital Value Chain • Processes • KPIs Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  22. What is a process? A collection of related, structured activities or tasks that produce a specific service or product (serve a particular goal) for a particular customer or customers. It often can be visualized with a flowchart as a sequence of activities with interleaving decision points or with a Process Matrix as a sequence of activities with relevance rules based on the data in the process. (Wikipedia) Dept. 1 Dept. 2 Dept. 3 Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  23. Dept. 1 Dept. 2 Dept. 3 Dept. 1 Dept. 2 Dept. 3 Dept. 1 Dept. 2 Dept. 3 How do we work in processes?3 Cases in real world 1 2 3 Lack of Trust Duplication Process Management Integration Lack of Process Mgmt. Bottlenecks Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  24. Dept. 1 Dept. 2 Dept. 3 Why is this so important? • Every person knows exactly what to do • We put the focus in the overall outcomes • Every action is replicable • We can easily measure the performance • We can introduce changes and analyze the results Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  25. Process Management at the hospital Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  26. Process Involvement at the Biomedical Department Society Purchase Devices IB Mgmnt. Installation Prev. Maintenance Corrective Maintenance Disposal Tools Management Personal Management Clinicians Patients Purchase Services & Parts Installed Base Management Training & Capacitating Vendors Management Budget Control Administration Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  27. Table of contents • Regulatory Framework EU • Hospital Value Chain • Processes • KPIs Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  28. What is a KPI? key performance indicator (KPI) is a type of performance measurement.  KPIs are commonly used by an organization to evaluate its success or the success of a particular activity in which it is engaged. (example of a KPI Dashboard) Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  29. Cuantitative Cualitative Directional Financial Types of KPIs Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  30. Some Examples of KPIs Subject Indicator Activities/Interventions Activities per device Activities per department Activities per type Activities Externalized vs. Total Installations Average time per installation Preventive Maintenance CTOM: Completition Time on Maintenance IMOT: Inspection Maintenance On Time Corrective Maintenance FTFR: First Time Fix Rate CTOR: Completition Time On Repair Activities due to Bad Use vs. Total Source of Contact: (Telephone vs. e-ticket) By device type Availability of devices (%) Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  31. Some Examples of KPIs Subject Indicator Employees Trainings per department Technical trainings per employee Activities per employee Installed Base # Devices over End Of Service Age Pattern of devices Financial Total Maintenance Cost per Device Maintenance Cost per department Cost of Inadequate use Maintenance Cost per Functional unit Maintenance Cost per Device and Manufacturer Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  32. Is this the end?… Next steps Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  33. Is this the end?Answer the following questions: • Do I have written down processes? • Do I have a Process Owner defined per process? • Is the involved personnel trained and committed? • Do I have defined at least 1 KPI per process, with a specific target? • Is the process owner monitoring the process? • Do I have a specific and regular program to analyze a KPI deviation, and take the proper actions? • Is the process owner empowered to introduce changes his/her process? • Do I have support from the top management? Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  34. Obstacles Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  35. Challenges/Obstacles The top Management is not committed. We have other priorities Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  36. Challenges/Obstacles We have externalized some activities. Over this we do not have proper information Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  37. Challenges/Obstacles We don’t have time. The daily work is too much Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  38. Challenges/Obstacles There’s a lot of change resistance. Not everybody is on board Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  39. Challenges/Obstacles We don’t have the proper tools and applications Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  40. There is always a first step Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  41. I everybody still on board? Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012

  42. Thank you for your attention.

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