Challenges Faced In Developing Safe Interoperable Systems in Healthcare. Tracy Rausch, CCE Founder and CEO DocBox Inc

Transcription

1 Challenges Faced In Developing Safe Interoperable Systems in Healthcare Tracy Rausch, CCE Founder and CEO DocBox Inc

2 Challenge Develop and implement of open, safe and effective interoperable system of systems, based on clinical requirements, which enables the creation of evidence based improvements in clinical care.

3 Requirements from Providers Complete and Accurate Data Safe Systems Secure Systems Increased Efficiency Clinical Workflow Device and Systems Maintenance Improved Quality Flexible (Inpatient to Outpatient) Able to deal with new and legacy equipment Scalable Facilitation of decision support and data visualization

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11 Problems ~400,000 people a year die from medical errors. $ $7000 per hospital admit is the estimated cost of adverse events. Data has incorrect or inaccurate time stamps Data is incomplete and incorrect Data lacks context Lack of data models systems level data models which describe the patient

12 Current Device System Solutions Vertically Integrated Proprietary Lacks Data Models Lacks correct time stamps Lacks contextually complete data Alarms are currently mostly limit alarms or single source alarms.

13 What about EHR s? What about Big Data? What about Quality Improvement Systems

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15 MetaVision EMR screen EMR time-stamp error ACT Machine 10:54 ACT appeared to have been checked 22 minutes after heparin administration (was actually 30 min). Could stroke. Cause ACT device time incorrect (Note - device does not use NTP) 8 minutes 11:02 Data protocol converter ACT Machine J. Goldman, MD MGH

16 smarter algorithms need to consider time course of device operations and interactions BP Cuff-SpO 2 Interaction (same arm) J. Goldman, MD MGH

17 Pulse Ox is set to: 16 sec averaging time What is the real O 2 saturation? Which value will be recorded in EHR or used by analytics engine Experiment: Pulse Oximetry Simulator is set to create transient de-saturation 99%->70%->99% 8 sec averaging time 2 sec averaging time Photos of pulse ox screens when they display the lowest saturation Julian M. Goldman, MD / MGH

18 Pulse oximeter signal averaging can hide physiological changes Neonatal Red and Infrared Data 6 seconds 76% 31% Studies suggests that in pre-term infants the desaturation rate may be as high a 7-10% per second (Poets et.al. Early Human Dev. 26, 1-12).

19 84% oxygen saturation detected by bedside physiological monitor Not recorded in permanent record No evidence of low SpO 2 in EHR (blue ticks along top) Patient Monitor Recorded Low SpO 2 Alarm Event 84% Julian M. Goldman, MD / MGH

20 EHR data 1 point collected 60 Seconds Example of possible EHR sample point Pulse Oximeter Displayed SpO2 at 8-second averaging time SPO2= 75 Based on this example, EHR May record SpO2 as: 75% Patient s actual SpO2 minimum = 70%

21 Sources of variation in EHR documentation d/t Data Sampling 60 Seconds Example of possible EHR sample points for 1-minute recording Pulse Oximeter Displayed SpO2 at 8-second averaging time SPO2= 75 Based on this example, EHR May record SpO2 as: 98% 92% 80% 75% Etc. Patient s actual SpO2 minimum = 70%

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23 The Future is Now!

24 The Future Requirements Requirements Requirements Consider the System Re-think Architecture Open Communication across vendors Design the System to be a learning System Learning System (black box recorder) Regulatory Considerations Modeling of data using a patient/data-centric approach.

25 Functional Elements of the Integrated Clinical Environment ASTM standard F Published January 2010 Clinician Integrated Clinical Environment (ICE) ICE Supervisor External Interface Network Controller Data Logger ICE Interface Medical Device ICE Interface Other Equipment Patient

26 Data-centric Approach Medical App 1 Medical App 2 Medical App n Data Logger Supervisor ICE Controller DDS RTPS Bus External Interface EMR/Other IS Systems Device Interface Device 1 Device 2 Device n

27 Smart PCA System App Enterprise Lab Results Patient Demographics and History Conditions Medication Orders CDS Algorithm(s) Point of Care Observations Sensor Data Other Infusions Safety Interlock Clinician Other Devices PCA Pump (Actuator) Patient

28 ICE System within Hospital IT Systems ICE ICE ICE Hospital Unit ICE ICE ICE Hospital Unit ICE Coordinator Pharmacy Lab ADT EHR Other Information Systems Data Warehouse Warehouse

29 Architectural Diagram ICE Manager ICE Systems Apps Clinical Documentation App Enterprise ICE Systems Apps ICE Coordinator CDS App 1 CDS App 3 CDS App 2 CDS App n CDS App 1 CDS App 2 Clinical Documentation CDS App n ICE Data Bus (DDS) ICE Coordinator Data Bus (DDS) 1 2 MD 3 MD 1 MD 2 MD n CDS App a EMR ADT Other 3 Data Warehouse Single Patient DB and App ICE System App Medical Device (MD) Interface Multiple Patient DB ICE Clinical App Hospital IT systems

30 Data Warehouse Coordinator 1 Coordinator 2 Coordinator n ICE Manager ICE Manager ICE Manager

31 Patient Information Model System of Systems model based on the patients data. DDS RTPS Bus

32 ICE and Analytics ICE ICE ICE ICE ICE ICE Categories of Analytics Real Time Analytics Patient Specific CDS Real Time Hospital Unit Hospital Unit ICE Coordinator Unit Level Analytics Pharmacy Lab ADT EHR Hospital and Hospital Systems Analytics Other Information Systems Data Warehouse Warehouse Clinical Studies and Outcomes Analytics Long Term & Retrospective

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34 Relationships of Data Measurement Device User Login User

35 Clinical Staff Patient Care

36 Questions??