Tel: +1 (610) 825-6000 ext. 5539 E-mail:...

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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

2© ECRI Institute 2013

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

© ECRI Institute 2013

Introducing… Today’s Webinar

Defining infusion pump integrationHow does this work?How to prepare for integration

TechnologyProcesses


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


Part 1:What do we mean by integrated infusion pumps?

“Seamless digital pathway”

- Nat Sims, MD


Three Flavors of Pump Integration

AutoprogrammingAutoverificationAutodocumentation


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


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


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


Part 2:How does this work?


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)

Does IHE support pharmacy integration?

Pharmacy IS, eMAR, flow sheets …

IPEC “start” / “stop” / “complete” event messages for infusion with a rate change ending in 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 …

Part 3:Why worry about the groundwork?


Laying the Groundwork

Technical ReadinessProcess Readiness


Technical Readiness- AAMI White Paper

Wireless coverageElectronic infusion ordersBedside barcode scanningElectronic documentationPatient association


1. Wireless Coverage

PervasiveResponsiveSecure


Pervasive Wireless Coverage

Care areas, ED, hallways, procedural or imaging, OR


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.


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/


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)


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


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


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


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


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)


Process Readiness

Integration TeamIntegration PlanVerification and ValidationChange management


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


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.”


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


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”


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


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


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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