Point of Care Testing and Informatics: Explosion Pathology Informatics Summit 2014

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
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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.