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Erin Sparnon, MEngSenior Project EngineerHealth Devices GroupTel: +1 (610) 825-6000 ext. 5539E-mail: [email protected]
Todd CooperBreakthrough Solutions FoundryEmail: [email protected]
Introducing... Erin Sparnon
Engineering degrees in Biomedical, Electrical, and Systems10 years at ECRI InstituteSome of my many hats…
IHE- Patient Care Devices planning committee, Point of care Infusion Verification workgroup, marketing liaison to IHE InternationalAAMI- Infusion Devices standards committee and IV Safety Council HIMSS and ACCE- Patient Safety workgroup
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Introducing… Todd Cooper
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Software Architect for major infusion pump &Ventilator systems
20+ years in medical device interoperability & informaticsSome of my many hats…
IHE International Board + IHE PCD Co-FounderCo-Chair HL7 & IEEE 11073 Device Working GroupsCo-Chair ISO / IEC “80001” JWG7Chair, ISO TC215, U.S. Delegation
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Introducing… Today’s Webinar
Defining infusion pump integrationHow does this work?How to prepare for integration
TechnologyProcesses
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AAMI HTSI White Paper:Best Practice Recommendations for Infusion Pump- Information Network Integration
Posted 8/9/2012Task force members include clinical engineering, IT, nursing, pump and EHR suppliersFree to download:
http://www.aami.org/htsi/SI_Series/Infusion_Pump_White_Paper.pdf
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Part 1:What do we mean by integrated infusion pumps?
“Seamless digital pathway”
- Nat Sims, MD
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Three Flavors of Pump Integration
AutoprogrammingAutoverificationAutodocumentation
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Autoprogramming vs. Autoverification
Scan• Patient, pumping channel,
medication• Establishes patient association
Send• BPOC sends order to pump
server• Pump server sends program to
pump
Start• Nurse views and verifies
therapy• Starts delivery
Scan• Patient, pumping channel,
medication• Establishes patient association
Start• Nurse programs and starts
pump manually • Pump sends program to pump
server
Check• Pump server sends program to
BPOC• BPOC checks program against
order and fires warnings
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Autodocumentation’s Promise: Less Typing, More Nursing
Data is streamed from pump to pump server, and then to EMRInfusion stop/start: continuous, loading, piggyback, bolusTitration Alert and alarm conditions― Opening or closing the pumping channel― Air in line― Occlusion upstream or downstream
Raw data must be verified by a nurse during reconciliation before it becomes part of the patient’s legal record
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Pumps are uniquely challenging
Don’t know who they are infusing into… or whereHighly mobile Deliver life-sustaining therapyDisconnect in time and space between an order and deliveryOne vendor owns the intellectual property around Autoprogramming
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IHE OverviewInternational organization organized by …
Clinical and Operations / Infrastructure Domain GroupsNational & Regional Deployment Committees
Pumps fall under the Patient Care Device (PCD) domain, sponsored by HIMSS, ACCE & AAMIIHE membership spans clinical, IT, standards development, education, research and government stakeholders
www.ihe.net/governance/member_organizations.cfm
What’s in an IHE Technical Framework Profile?
“Final Text” = Product Ready!
4 Volumes in Tech. Framework:1. Integration Profiles2. Transactions (messages)3. Semantic Content4. National Extensions – TBD PCD
One Tech Framework per Domain
Frameworks are International
www.ihe.net/Technical_Framework
What’s in an IHE Technical Framework Profile?Addresses a specific integration problemProfile name
“Point-of-care Infusion Verification” (PIV) supports 5-rights messages from clinical systems like PhIS to pump servers
Technical solutions based on non-proprietary open standardsActors: labels with defined roles and responsibilities
A system may send, receive, or filter (receive, modify, then send) dataTransactions: descriptive name and an identification number
“PCD-01 Communicate PCD Data” is a general message typeMessages: the content and format of information transferred
Using HL7, put the patient name in field x, and the heart rate in field y…See www.ihe.net/profiles
What’s in an IHE Technical Framework Profile?
“Point-of-Care Infusion Verification” (PIV) Profile
Actors (logical / functional system role)
Transactions(HL7 ver 2.6 messages with IEEE 11073 semantic content)
Out of Profile Scope
What profiles are relevant for infusion pumps?Consistent Time (CT)
Provides time synchronization; required for ALL profiles (NTP/SNTP)Device Enterprise Communication (DEC)
General device info reporting (periodic & aperiodic))Alarm Communication Management (ACM)
Distributed alarm communication supportPoint-of-care Infusion Verification (PIV)
5-Rights validated program communication Infusion Pump Event Communication (IPEC)
Notifications of major operational milestones / transitions (e.g., KVO)
•Visit the Clinical/Operational Domains: • Anatomic Pathology• Cardiology• Eye Care• IT Infrastructure*
• Each Domain’s Technical Framework will spell out the transactions supported in each profile www.IHE.net / Technical_Framework
• Laboratory• Patient Care Coordination*• Patient Care Devices*• Pharmacy
• Quality, Research and Public Health*
• Radiation Oncology• Radiology
How can I tell if there is a profile that describes the clinical workflow I need?
How can I tell if a system supports IHE profiles?
Ask to see an Integration Statement for the profile you’re interested in; consult product registry @ product-registry.ihe.netIf an integration statement is unavailable, request conformance in an RFP …
Technical Readiness- AAMI White Paper
Wireless coverageElectronic infusion ordersBedside barcode scanningElectronic documentationPatient association
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Pervasive Wireless Coverage
Care areas, ED, hallways, procedural or imaging, OR
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Responsive Wireless CoverageMust be reachable within seconds
Workarounds grow with delays*“Bring your own device” for clinicians is eating into bandwidthMust tolerate short outages
Store and forward documentation
*Patterson ES, Rogers ML, Chapman RJ, Render ML. Compliance with intended use of Bar Code Medication Administration in acute and long-term care: an observational study. Hum Factors. 2006 Spring;48(1):15-22.
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Secure Wireless Coverage
Pump communication may carry protected health information (PHI) → HIPAA
Some autoverification scenarios may be exempt if all patient matching is done in the pump server
WPA2 is widely supported, but others are notFIPS- Federal Information Processing Standards*
*http://www.itl.nist.gov/fipspubs/
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2. Electronic Medication Orders
Must include all parameters required for BPOC verification and infusion programmingCPOE may only capture medication, dose, time, and titration advicePharmacy must fill in other parameters during verification and map them to medication supply cabinet and pump’s drug library
Consider orders that are auto-verified? (Emergency department, Stat)
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Medication Order Parameters
Patient IDDrug ID corresponding to a drug entity within the drug library in the pumpConcentration or amount of medication in diluent volumeBag, syringe, vial, or other fluid container sizeInfusion dosing parameters like dosing unit, continuous dose rate, bolus or loading doses, or PCA settingsTime or volume to be infusedTitration protocols
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3. Bedside Barcode Scanning
Barcode-enabled point of care (BPOC) aka Bar Code Medication Administration (BCMA) is the only successful patient association strategy to date
Using a scanner hooked up to the pump never took off50% of US hospital pharmacies surveyed by ASHP in 2011 use BPOC
BPOC compliance sets the stage for integration workflowBPOC workflow brings electronic verification and documentation systems to the bedside Clinicians are accustomed to scanning patients and medications
ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration--2011. Pedersen CA, Schneider PJ, Scheckelhoff DJ. Am J Health Syst Pharm. 2012 May 1;69(9):768-85. PMID:22517022
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4. Electronic Documentation
Electronic Medical Records (EMR) need to be ready to receive and hold infusion data
Designed to support periodic manual documentation of clinical care Like medication orders, may lack fields to hold pump data• Patient ID• Drug ID• Time of Delivery• End time of Infusion• Dose• Rate
• Bag/bottle/syringe capacity
• Amount of drug• Amount of diluent• Intended time or volume
of infusion
• Volume infused and volume remaining to be infused
• Which channel of a pump is reporting information
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Drinking from a Fire Hose
Pump servers are a continuous data streamDesigned to hold full-disclosure, continuous data to support incident investigation and quality improvementAlert and alarm data results in data overload
Translation and filtering into EMR-acceptable format is necessary
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5. Patient Association
BPOC workflow enables scanning of patient, medication, and pumping channel… if each are labeled Durable, readable bar code on each pumping channel
Contains pump identifier (not serial number), channel identifierMachine-readable and human-readable (if scan doesn’t work)Withstands cleaning, spills, other daily abuseInspected regularly (e.g., during cleaning/distribution)
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Process Readiness
Integration TeamIntegration PlanVerification and ValidationChange management
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Integration Team
One integration champion for all medical device integration (MDI) with an executive mandate and a team of nursing, CE, IT, materials, pharmacy, informatics, research, quality, risk, clinical managers
Make sure integration goals match clinical information needsBudgeting for equipment, software, development time, consultingWriting RFI language for new purchasesOwning maintenance of integration Collecting and analyzing performance data
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Integration Team
Executive mandate is critical to success
“We have a meeting every 2 weeks with a prioritized list of clinical issues that must be fixed by IT within 2 weeks. Executive mandate says IT must complete the list each time.”
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Integration Plan
Document developed and maintained by the Integration TeamServes as the unified organizational plan to share with pump and information system suppliersHolds observations for each care area and each care practice
Study of current nursing workflow Use cases for integration
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Verification and Validation
Rounding and truncation can be a major problem for weight-based dose calculations,
Causes discrepancies that are clinically insignificant but cause big headaches
Fluids can confuse documentation systems
“Epic used to calculate a mg dose for dextrose. Epic had to figure out how to not do this calculation. This is why you need to test EVERY med. Fluids were one of the most problematic things”
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Verification and Validation
Test orders for each drug entity in the pump’s libraryOrder triggers the right drug entity and any appropriate dose error reduction system limits (autoprogramming)Programming errors trigger appropriate alerts in BPOC (Autoverification)After Start, administration is properly documented in EMR
Test each alarm and alert condition transfer into the EMR
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Change Management
Consider the “ripple effect” for changes in medication names, concentrations, bag/container sizes, diluent
Electronic order setsPharmacy information systemsMedication cabinet or drug stockInfusion Pump Drug Library
Medication shortages and substitutions can exacerbate problems
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Wrap-up and Questions
Infusion pump integration is growing and impacts current technology decisionsStandards exist- request them!Groundwork includes wireless infrastructure, electronic orders, electronic documentation systems, bedside bar coding, and patient association
Todd Cooper Erin Sparnon, MEng
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