Hospital Summit. Processes and KPIs Health Care Value Chain Rafael Provencio Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 2| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 What is the goal of the regulatory framework? The target of the regulatory framework is to keep safety and performance on Medical Devices 3| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 General Framework Directive 93/42/EEC concerning Medical Devices Amendments Directive 98/79/EC In vitro medical devices Directive 2000/70/EC Human blood/plasma Directive 2001/104/EC Regulation 1882/2003 Commitees to assist the Commision Active implantable Medical Devices 4| Human blood/plasma Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Directive 2007/47/EC General Framework Some topics about medical device safety: i. Complete safety is not achievable ii. It is a Risk Management issue iii. It is deeply linked with device performance iv. It must be considered through the life spam of the device v. It requires shared responsibility over all parts involved 5| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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 Product Safety Electromag. compliance User knowledge Ergonomic design With this goal the essential requisites are being established so they must be fulfilled by the devices and accessories, including software Protection Radiation 6| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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 7| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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”. 8| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Classification of Devices EU & EFTA Risk Portable ECG, thermal blanket, thermal cushion, newly-born cradle, mannequin… Class I Non Invasive, Reusable surgical instruments, invasive <1min Annex IX of the Council Directive 93/42/EEC 9| Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Classification of Devices Risk EU & EFTA Class IIa Blood Pressure Monitor, ECG, CPAP System, contact lenses, spirometer… Annex IX of the Council Directive 93/42/EEC 10 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Classification of Devices EU & EFTA Class IIb Risk Invasive long term, supply energy, medicine administration, ionizing radiation, therapeutic devices, monitoring of therapeutic devices Anesthesia device, central gas station, vaporizator, respirator, bronchial aspirator, infusion pump, incubator, hyperbaric chamber, pacemaker Annex IX of the Council Directive 93/42/EEC 11 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Classification of Devices EU & EFTA Class III Risk Connection to nervous system, heart or central regulatory Annex IX of the Council Directive 93/42/EEC 12 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Classification of Devices EU & EFTA Class III Connection to nervous system, heart or central regulatory Class IIb Risk 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 13 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Directive 93/42/EEC in the Device’s Life Cycle Manufacturer Development Manufacture Vendor Packaging Labelling •CE Marking: Art. 17 Installation Promotion Purchasing •Essential requirements: Art. 3 Sale At the Hospital Production Disposal Maintenance •User trainings •Legal representative of the “The lack Manufacturer of, or inappropriate, calibration •Adverse events surveillance and maintenance can seriously jeopardize •Acquire proper knowledge the device according to the their safety and performance. These •Use issues •Declaration of conformity: Art. 11 designed purpose •Ensure installation (Art. 2) are often overlooked or underestimated” •Details of conformity assesment •Post-market surveillance World Health Organization (Art. 10) GMPs ISO standards: ISO 9001:2008 ISO 14001:2005, ISO 13485:2003 15 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 ISO 9001:2008 ISO 14001:2005 ISO 13485:2003 •Ensuring that the device is performing as it was designed No homogeous situation Up to every hospital Directive 93/42/EEC in the Device’s Life Cycle Manufacturer Development Manufacture Packaging Labelling Purchasing •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 16 | Manufacturer Vendor Sale Installation Promotion At the Hospital Production Disposal Maintenance •Legal representative of the Manufacturer •User trainings •Adquire proper knowledge •Ensuring that the device is performing as it was designed •Ensure installation •Adverse events surveillance •Post-market surveillance ISO 9001:2008 ISO 9001:2008, ISO ISO 14001:2005 14001:2005, ISO 13485:2003 ISO 13485:2003 Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 No homogeous situation to every hospital NoUp homogeous situation Up every hospital ISOto9001:2008, ISO 14001:2005, ISO 13485:2003 Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 17 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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) 18 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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! 19 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Obstacles to the Healt Care Value Chain 1. Paper shuffling 2. Lengthy product ordering and delivery cycle times 3. Multiple product handling activities 4. Excessive inventory carrying costs 5. Lack of information sharing among trading partners 6. Little information on product location and utilization 7. Operational focus (instead of customer focus) 8. Pressure to cut short-term costs 9. Lack of trust between partners 10. Lack of easy business mechanics (e-commerce) (The Health Care Value Chain: producers, purchasers and providers Lawton R. Burns) 20 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Value Chain vs. Five Forces 21 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 22 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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 23 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Dept. 2 Dept. 3 How do we work in processes? 3 Cases in real world 1 2 Lack of Trust Duplication Dept. 1 24 | Dept. 2 Dept. 3 3 Lack of Process Mgmt. Process Management Bottlenecks Integration Dept. 1 Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Dept. 2 Dept. 3 Dept. 1 Dept. 2 Dept. 3 Why is this so important? Dept. 1 Dept. 2 Dept. 3 1. Every person knows exactly what to do 2. We put the focus in the overall outcomes 3. Every action is replicable 4. We can easily measure the performance 5. We can introduce changes and analyze the results 25 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Process Management at the hospital 26 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Process Involvement at the Biomedical Department Society Purchase Devices IB Mgmnt. Installat ion Prev. Mainten ance Correctiv e Mainten ance Dispos al Personal Management Purchase Services & Parts Installed Base Management Training & Capacitating Vendors Management Budget Control Administration 27 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Patients Clinicians Tools Management Table of contents 1. Regulatory Framework EU 2. Hospital Value Chain 3. Processes 4. KPIs 28 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 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) 29 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Types of KPIs Cuantitative Directional 30 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Cualitative Financial Some Examples of KPIs Subject Activities/Interventions Indicator Activities per device Activities per department Activities per type Activities Externalized vs. Total Installations Preventive Maintenance Average time per installation 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 (%) 31 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Some Examples of KPIs Subject Employees Indicator 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 32 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Is this the end? … Next steps 33 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Is this the end? Answer the following questions: 1. Do I have written down processes? 2. Do I have a Process Owner defined per process? 3. Is the involved personnel trained and committed? 4. Do I have defined at least 1 KPI per process, with a specific target? 5. Is the process owner monitoring the process? 6. Do I have a specific and regular program to analyze a KPI deviation, and take the proper actions? 7. Is the process owner empowered to introduce changes his/her process? 8. Do I have support from the top management? 34 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Obstacles 35 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Challenges/Obstacles The top Management is not committed. We have other priorities 36 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Challenges/Obstacles We have externalized some activities. Over this we do not have proper information 37 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Challenges/Obstacles We don’t have time. The daily work is too much 38 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Challenges/Obstacles There’s a lot of change resistance. Not everybody is on board 39 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Challenges/Obstacles We don’t have the proper tools and applications 40 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 There is always a first step 41 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 I everybody still on board? 42 | Rafael Provencio. Process Management. Biomed Event, Hospital Summit. 30.10.2012 Thank you for your attention.