Point of Care Testing and Informatics: How to Prepare for the POCT Explosion Pathology Informatics Summit 2014 David McClintock, MD May 14, 2014 Disclosures • No conflicts of interest with any content presented today • Any products or vendors mentioned today are for presentation and information purposes only • They do not represent any form of endorsement on my part Who Am I? • Medical Director of Pathology Informatics • Medical Director, Point of Care Testing • Primary CLIA holder for all POC Laboratories on UCM Main Campus • Assistant Professor, Pathology • AP/CP Boarded • Protein Electrophoresis (SPEP/UPEP) 3 Pathology Informatics…What is it?? The application of informatics to Pathology and Laboratory Medicine Adapted from: John Sinard. Practical Pathology Informatics, 2006, p.1 4 What Is Informatics? • The science of information • Study of how data is: • • • • • • • Acquired Structured Stored Processed Retrieved Analyzed Presented / Communicated Modified from: John Sinard. Practical Pathology Informatics, 2006 5 INFORMATICS DATA INFORMATION 6 INFORMATICS Clinical Laboratory Data C P Actionable Clinical Information Monoclonal IgG kappa present at the anodal edge of the gamma globulin region, concentration estimated at 6.5 g/dL, accounting for essentially all gamma globulin staining. This interpretation is based on review of both the routine protein electrophoresis gel and the immunofixation gel. 7 Informatics Defined • Informatics is studying how to design a system that delivers the right information, to the right person in the right place and time, in the right way • Intimately tied to information systems, workflow, and standards From: Wikipedia, Informatics (academic field). Available at http://en.wikipedia.org/wiki/Informatics_%28academic_field%29, cited 04-05-13 8 Pathology Informatics - Defined Delivering pathology and laboratory information to the right person, in the right place and time, in the proper context The study and management of information, information systems, and processes in pathology Point of Care Testing Patient specimens, assayed at or near the patient, with the assumption that test results will be available instantly or in a very short timeframe to assist caregivers with immediate diagnosis and/or clinical intervention From: Plebani M. Does POCT reduce the risk of error in laboratory testing? Clinica Chimica Acta. 2009, 404: 59-64. Point of Care Informatics Delivering point of care testing information to the right person, in the right place and time, in the proper context But aren't we already doing this? Isn't that the point of POCT??? Point of Care Testing (POCT) • A.K.A "bedside" or "near-patient" testing • Usually simple to perform lab test performed near patient • Typically characterized by rapid turn-around-times • Adoption driven by clinicians • Quickly emerging field of laboratory medicine • Rapidly growing with great clinical interest • Over 100 waived and non-waived POC tests available • Requires significant oversight • Laboratory Medicine MUST have a role in POCT POCT: A Timely Topic POCT: A Timely Topic “With point-of-care testing, I think we’ll be amazed by what happens in five years. And we’ll be stupefied at what we’ll be able to do in 10 years.” Long Tradition of Point of Care Testing • Earliest form of laboratory testing • Dates back to ancient Egypt, Babylon, India (thousands of years ago) • Tasting of urine samples for diabetes • Uroscopy "Physicians" observing urine characteristics to diagnose disease • Red urine = hematuria • Brown urine = jaundice • Foamy urine = proteinuria POCT - History POCT – Recent History • Bedside glucose has been the predominant POC test performed in the clinical setting • CLIA'88 clearly defined the category of "waived" testing • 1994 – first use of the term "point-of-care testing" in the literature • 2000-present: Explosion in the number of POC tests and devices Types of POCT • Waived testing • Testing cleared by the FDA for home use • Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible • Pose no reasonable risk of harm to the patient if the test is performed incorrectly • For clinical use – must follow manufacturer's instructions…but that's about it • Non-waived testing • Provider performed microscopy (PPM) and moderately complex testing • THERE REALLY SHOULDN'T BE HIGH COMPLEXITY TESTING FOR POCT Common Examples of POCT • Bedside glucose testing - WAIVED • Blood gases and electrolytes - NON-WAIVED • Coagulation • Activated clotting time - NON-WAIVED • PT/INR - WAIVED • • • • • • • Cardiac markers – NON-WAIVED Hemoglobin A1c – WAIVED Provider-performed microscopy - PPM Fecal occult blood testing - WAIVED Dipstick urinalysis - WAIVED Urine pregnancy testing – WAIVED Infectious disease testing: • Rapid strep A - WAIVED • Influenza A/B – WAIVED • HIV - WAIVED Major Challenges in POCT • Cost • Medical necessity • Test utilization • Analytical quality • Test performance by non-lab personnel • Regulatory concerns • Impact of POCT on hospital and central lab operations Point of Care Informatics • Delivering point of care testing information to the right person, in the right place and time, in the proper context • Encompasses NOT JUST patient results, but also specimen acquisition, positive patient ID, QC, competency assessment, proficiency testing, etc. • What is the right place and time and the proper context for all POC information? • Who is the right person? The physician? The nurse? • What else is needed after the provider reviews the results from the instrument? Is there additional information recorded that is pertinent to the result? • What information is needed for proper oversight? • Critical Value documentation, reportable ranges, etc. POCT and Informatics • Most hospitals only transmit a fraction of POCT data into their EMRs • Complicated by the fact that results are available at the point of care… • Due to the decentralized nature of POCT, oversight can be difficult: • Poor document control • Inconsistent quality control data • Incomplete competency assessment records for testing personnel • Hundreds to thousands of test operators exist…basically all of the nurses, nursing assistants, ER techs, OR techs, etc. • Incomplete billing for POC tests • Physicians are bad (really, really bad) at following regulatory POCT Information Systems 1. Manual Records 2. POC Device Computer Direct Connection 3. POC Device Computer Networked Connection EMR (if you were lucky) 4. Direct Entry of Results into EMR 5. POC Device Enterprise Middleware Solution EMR 6. Wireless POC Device Vendor Middleware Enterprise Middleware (may be optional) EMR NOTE: IN ALL CASES, THE LIS MAY BE OPTIONAL!! (Separate topic for discussion…) Manual Records • Original record keeping for all POCT • Essentially writing down results, QC, competency all on paper • Manual entry to LIS possible • Unfortunately, NOT obsolete • Primary method for most manual, visual read POCT tests (e.g. urine hCG) • Primary method for temperature monitoring (everyone hates this on the floors) • For many places, primary method for competency assessment • True for many central labs too • Used for low-volume, instrument based tests when interfacing is too expensive or too difficult to network POC Device Computer Direct Connection • Early way of connecting POC devices to local information systems • First seen with POC glucose meters • Laptops physically synced to device • Primarily were used for historical data archive • Not able to be interfaced to LIS or EMR • Rarely used today POC Device Computer Networked Connection • Next generation systems to support POC glucose testing • Central desktop computer networked to instrument docking stations • Initially modem based (base stations connected to phone lines) • Some systems with ethernet connectivity • Interfacing to LIS/EMR finally possible (for some glucose systems) POCT Resulting – Direct Entry into EMR • POCT results are directly entered into the EMR • Flowsheet rows in nursing Lab values as nursing observations • Primary method for many for POC glucose testing • Allows nurse to document additional patient information and treatment details in same location as POC test values • E.g. for POC glucose, can document if patient was postprandial, amount of insulin given, medication given, how patient felt at time of test, etc. • POC Result Entry/Edit • Allows for "Solicited" result with physician POC test order • Test operator performs test, enters result into EMR with associated order Flowsheet Rows in EMR Manual Result Entry/Edit into EMR Manual Result Entry/Edit into EMR POC Device Enterprise Middleware Solution • Current model for most to manage POC results • NOT ALL PLACES HAVE ONE!!! Which means…some combination of the last three are still being used!!! • Allow multiple devices to interface with one information system • Not all POC devices share the same functionality system functionality can vary per device • Main systems on market today vary primarily based on: • Promiscuity (how many devices can it interface with?) • POC device software integration (pass thru vs. configuration vs. complete analytics) POC Device Connectivity - Example Example POC Middleware Setup Testing Personnel (Nurses, Techs, etc.) POC Result Entry Web Client POC Glucose Vendor POC Coordinators Vendor Device Middleware POC Middleware Client(s) POC Device Driver POC Device Driver POC ACT Vendor ADT Pass Thru Results Import and Rules POC Middleware Server ADT Proc(s) POC Middleware Database ADT Comm(s) ADT Messages EMR/Registration Orders Proc(s) Interface Rules Processing and Transmission Orders Comm(s) Order Messages Solicited Results Unsolicited Results LIS Wireless POCT Systems Benefits of Wireless Connectivity in POCT • "Real-time" automated transfer of patient and QC results to the EMR • Allows POCT results to be treated as typical lab values • Save nursing time (expense) for entering results, improve compliance • Trending of POC results possible since all values now go to EMR reliably • Updated patient registration, encounters on the device • Enhanced patient ID lookup can help with patient safety • Order/Result solicitation possible with some POC middleware systems • Ability to push configuration updates wirelessly to devices • Enforce competency assessment and operator lockout on Disadvantages of Wireless in POCT • "Real-time" can be a misnomer… • Not all wireless networks are created equal (dead spots, connection issues, downtime, bandwidth limitations) • Device syncing can take seconds…minutes…hours • ADT information coming in can delay sync time of results • Providers become dependent on results posting to EMR in minutes – delays can affect patient care, nursing notes and documentation, encourage workarounds • Not all ADT messages are created equal • ADT message structure and configuration can vary – auto d/c may not work • Location mapping in POC middleware may not be accurate • Patient information fill up devices with finite space – can cause errors Wireless – Yes or No? YES! • Wireless technology is the key to automating compliance, competency assessment, and QC • Vendors Unless if has wireless, don't call me!! Preparing for the POCT Explosion Bliss image from: http://www.nydailynews.com/life-style/bliss-photog-shares-story-famous-windows-xp-image-article-1.1754436 GIF image from: http://imgur.com/gallery/Tptup “With point-of-care testing, I think we’ll be amazed by what happens in five years. And we’ll be stupefied at what we’ll be able to do in 10 years.” • Technological advances are making POC testing practically equivalent analytically to central lab testing • Studies are showing how POCT can improve workflow inefficiencies in clinical workflows (e.g. POC Creatinine and Radiology) • POCT has high patient satisfaction, decreases physician followup activities (calls, letters, emails), and has immediate therapeutic implications Future Direction of POCT - Summary • With technological advances, Point of Care Testing is becoming more mobile, more sophisticated, and more accurate • As cost per test decreases, demand will skyrocket in areas such as ICUs, EDs, ORs, urgent care clinics, physician offices, “quick” care clinics, etc. • Very sophisticated molecular and infectious disease POCT are on the horizon (even POC PCR!) • With increasing volumes, stewardship of POCT data is of paramount importance • Competency assessment, cost/utilization, QC, Proficiency Testing are key • AUTOMATION AND INFORMATICS IS REQUIRED TO MAKE THIS WORK!!! Questions? Solicited vs Unsolicited Results • Solicited results • Results for which the receiving system has an open order that is waiting for results to be posted • Processing model used almost exclusively within the central laboratory (including waived tests performed in central lab) • Allows for complete audit trail (closed loop) from provider order to results posting • Unsolicited results • Results for which the receiving system does not have an order • Upon receipt of the result, orders are auto-generated on the appropriate patient encounter and the result posted • Processing model traditionally used for POCT outside of the central lab Solicited vs Unsolicited Results - Debate • POCT has traditionally used unsolicited resulting…because there was no consistent way to match up results with an order • Many POCT were (are) verbal orders • May be part of order or treatment protocols (e.g. insulin-sliding-scale) • With CPOE and EMRs, in combination with wireless POC devices, feasibility of solicited results for POCT has improved • ICU and routine patient care settings (e.g. prn blood gases, glucose, ACT, etc.) • Physician offices • Some areas would have to remain unsolicited • ORs, ERs, remote physician offices, etc.
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