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Clinical Scenario #1 Patient Controlled Analgesia

Part 3: Analysis of Current State Workflow

Working Draft Version 5.1

Quantum Medical Device Interoperability (QMDI) Project

PI: Julian M. Goldman, MD

Funded by

National Institute of Biomedical Imaging & Bioengineering

Prepared by DocBox Inc.

and

Medical Device Plug-and-Play (MD PnP) Program CIMIT / Massachusetts General Hospital

Current versions of this and related documents can be found at http://mdpnp.org

August 2012

This work is licensed under a Creative Commons Attribution-ShareAlike 3.0 Unported License

Contents Clinical Workflow Analysis................................................................................................3 Zachman Framework .......................................................................................................4 Data Analysis Detail .........................................................................................................8

Infusion Therapy ............................................................................................................8 Monitor Patient ..........................................................................................................10 getISData(patientID, EMR, Labs) .............................................................................14 getObservationData(5RDrugCheck) .........................................................................15 getObservationData(nurseCheck) ............................................................................20 getOrders(patientID) .................................................................................................25 getPhysData(patientID, vitals) ..................................................................................26 manualProcess: Administer Infusion.........................................................................27 manualProcess: Bolus Infusion Administered by Patient (If PCA)............................27 manualProcess: Pump/Line Removal Process.........................................................27 setObservationData(IVassessment) .........................................................................27 setSettings(infusionPump) ........................................................................................33 setSettings(monitor) ..................................................................................................38 Begin Infusion Management .....................................................................................43 End Infusion Therapy Process..................................................................................43 Continue Infusion ......................................................................................................43 Does the Patient Require Monitoring with this Infusion ............................................44

Diagram: Primary Use Case...........................................................................................44 Timing Diagram: Infusion Therapy .................................................................................45

Clinical Workflow Analysis This work began in 2006 and is a Scenario in the ASTM F2769 Standard located in Annex B. Originally these workflows were developed in Microsoft Visio but the ability of adding additional analysis details was not available in Visio. The models were then built in Altova UModel, but found it was difficult to create reports and it also didn’t provide enough robustness for modeling. This scenario was most recently created in Enterprise Architect which allows for UML, and Use Case Diagrams.

• Diagram Boxes in Green signal a Manual Clinical Process (i.e. a nurse hangs an IV bag) • Diagram Boxes in Red signal that a Comparison between two data points is required (compare

dose on pump with dose in Order) • A ∞ at the bottom of a workflow block signals that there is an additional page of workflow.

Zachman Framework Perspective Why

Motivation (Why is a safety interlock PCA pump important?)

How Process (How would it be used in clinical setting?)

What Artifacts (What info is related to its use in clinical setting?)

Who Actors (Who are involved?)

Where Location (Where is the device likely to be used?)

When Timing (What time constraints are related to use in clinical setting?

Physician • Could prevent physician error from becoming medication error

• Confidence in what nursing staff does.

• Reduce malpractice insurance payments.

• Saves time. • Better pain

management for patient.

• More consistent care for patients.

• Write an electronic, paper, or verbal order for PCA interlock which would include several limits.

• Patient history, demographics

• Patient state • Med list • Allergies • Feedback from

patient • Write an order –

electronic, paper, or verbal.

• Existing manual process and inherent safety checks need to be translated to automated system

• Physicians • Residents • Interns • Nurses • Clinical Asst. • Family • Respiratory • Pharmacy

• Med-SURG • ICU • Post-SURG • Home use

Doctor decides which patients are good candidates for PCA. Patient is complaining of pain.

Nurse • Improves patient comfort.

• Better pain control • Fewer codes • Discharge patients

faster • One less task to be

concerned about. • Concerns about

automation taking over their task…

• Training issue • Can change

Set up PCA based on physician order • How to find

devices • How to set up

system and getting the drugs

• How to educate

patient

• Nurses notes • EMR and EMAR (Electronic medical administration record) • Finding the PCA

device CMMS computerized material management system

Who is authorized to override limits?

• Bedside • Nurses’

Station • Med-SURG • Home

• Post-op • When order

received • Repeat every x

hours • Respond to alarms

from pump(s) and safety interlock, monitoring devices, nurse call button…

Perspective Why Motivation (Why is a safety interlock PCA pump important?)






monitoring limits if patient complains of pain and is locked out…

• Could help automate documentation procedures

• How they monitor

patients • How to adjust

dosage and monitoring limits

• How to override

limits

– keeps track of all devices, version of software, hardware etc.

Patient • Reduce likelihood of overdose

• Less pain • More control over

pain mngment • Improved quality

of care, safer • Fewer nurse

interactions • Pain meds

delivered faster • Mitigates harm of

“PCA by proxy” • Mitigate harm in

complex pain scenarios – for opioid-tolerant patients

• Same button but don’t get locked out as often…

• Need to communicate relevant facts in their patient history

• Patient and family members

• Med-Surg • Home • arms

• Post-op • other pain

management situations.

Clinical Engineer

• makes adverse event analysis easier

• fewer investigations

• difference in testing new pumps before placed on floor (equipment

• clinical protocols • test procedure

and records • test harness • equipment logs

• BMETs • Nurses • Physicians • Pharmacist • IT

• Labs • Floors • Test network

• Incoming inspection

• Scheduled maintenance

• Malfunction







• increased info in real-time for system management

• simplifying connectivity

• compatibility issues with connected equipment

acceptance) • test equipment

• 80001 and other regulatory stuff

• Materials Management

• Vendor

reported • Software updates • Drug library

changes • Infrastructure

changes

IT Staff and Infrastructure

• Could take precedence over other devices on an IT network

• If network adversely affected devices, would have to shut network down

• Increase in inter-device communication that is safety critical

• Could get a call from clin engineer or other person that device is affecting network or vice versa

• Trouble ticket • IT Procedures

• Clin Engr • BMET • IT Call List • Help Desk

• Throughout the hospital

• Off-site (remote servers)

•

• On-call • Installing new

systems and equipment

• Updating network • Updating

software • Update anti-virus

software

Hospital Admin –Purchasing

• Equipment could initially be more expensive

• Fewer vendors that sell this equipment

• Maintain/ enforce rules on what equipment can be

• Purchasing procedures

• Approved Vendor lists

• Approved device lists

• Procedures • Purchase Orders

• Doctors, nurse managers

• Dept Heads • Materials

Mangment • Clinical Engrs • Pharmacists

• Dept offices • Capital budget planning time

• When a doctor demands a device…







bought Hospital - Quality and Safety

• Adverse Events • • • • •

Hospital – Risk Management

• Legal issues? • • • • •

Medical Device Manufacturer

• Opportunity to make more money

• New marketing fodder

• Competition • Feedback • Safety • Cost and liability

issues • Concerns over

safety and liability if one component fails

• Existing QSR and SOPs

• Requirements new and different

• V&V will be new and different

• Risk management will be challenging

• Integrating other vendor’s devices

• SOPs • Records • Usual stuff

• Internal QA • Clinicians to

help specify and design and validate

• Field service engineers

• Internal staff (nurses)

• MDM facility • Clinical trial

sites

• Product development

• Product Maintenance

Regulators (FDA and JHACO)

• Who’s at fault • How to deal with

risk mitigation in mixed vendor systems

• How to process adverse event reports?

• New indicators for JHACO

• Regulations and guidance docs

• Communication with device manufacturers and hospitals and own staff

• Regulations and guidance

• Communications with industry and healthcare orgs

• Warning letters?

• Med Device manufacturers

• Hospitals • Standards

orgs (AAMI, others)

• • Time to review and approve device

Data Analysis Detail This document provides an overview of the data model. For simpler and more focused reports, simply copy this initial template and turn off the sections not required.

Infusion Therapy Type: Package Package: Process Model Detail: Created on 1/5/2006. Last modified on 3/23/2011. Notes: Infusion Therapy Created By: Michael on 1/11/2006 Last Modified: 8/13/2012, Version:1.0 This process is completed by the nursing staff. It requires orders from a physician but they are not part of the documented process unless there is a sudden change in patient status.

Figure: 1

Monitor Patient Database: <none>, Stereotype: «BusinessProcess», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Monitor Patient. Target: Monitor Patient.

Source: setSettings(monitor). Target: Monitor Patient.

BPMN 1.0 diagram: Monitor Patient

compare: getPhysData(vitals) to getAlarmSettings(device) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

getAlarmSettings(device). Target: compare: getPhysData(vitals) to getAlarmSettings(device).

Source: compare: getPhysData(vitals) to getAlarmSettings(device). Target: Are vitals within alarm limits?.

Continue Patient Monitoring Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Continue Patient Monitoring. Target: setISData(baseLine vitals).

Yes Source: Are vitals within alarm limits?. Target: Continue Patient Monitoring.

getAlarmSettings(device) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Data Attributes Name Type Notes Pulse Rate high limit Integer Pulse Rate low limit Integer Respiratory Rate high limit Integer Respiratory Rate low limit Integer SpCO2 high limit Integer SpCO2 low limit Integer SpO2 high limit Integer SpO2 low limit Integer

Connections Name Association Notes Source:

getPhysData(vitals).

Name Association Notes Target: getAlarmSettings(device).

Source: getAlarmSettings(device). Target: compare: getPhysData(vitals) to getAlarmSettings(device).

getPhysData(vitals) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Data Attributes Name Type Notes Pulse Rate Integer Respiratory Rate Integer SpCO2 Integer SpO2 Integer


setISData(baseLine vitals). Target: getPhysData(vitals).

Source: getPhysData(vitals). Target: getAlarmSettings(device).

Source: triggerAlarm(device, alarm). Target: getPhysData(vitals).

Yes Source: Is Alarm Triggered?. Target: getPhysData(vitals).

setISData(baseLine vitals) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Data Attributes Name Type Notes Blood Pressure Integer Pulse Rate Integer Respiratory Rate Integer SpCO2 Integer SpO2 Integer Temperature Integer

Connections Name Association Notes

Name Association Notes Source:

Begin Patient Monitoring. Target: setISData(baseLine vitals).

Source: setISData(baseLine vitals). Target: getPhysData(vitals).

Source: Continue Patient Monitoring. Target: setISData(baseLine vitals).

triggerAlarm(device, alarm) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Data Attributes Name Type Notes device String Pulse Rate high alarm String Pulse Rate low alarm String Respiratory Rate high alarm String Respiratory Rate low alarm String SpCO2 high alarm String SpCO2 low alarm String SpO2 high alarm String SpO2 low alarm String


triggerAlarm(device, alarm). Target: getPhysData(vitals).

No Source: Is Alarm Triggered?. Target: triggerAlarm(device, alarm).

Are vitals within alarm limits? Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

compare: getPhysData(vitals) to getAlarmSettings(device). Target: Are vitals within alarm limits?.

No Source: Are vitals within alarm limits?.

Name Association Notes Target: Is Alarm Triggered?.

Yes Source: Are vitals within alarm limits?. Target: Continue Patient Monitoring.

Is Alarm Triggered? Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes No Source:

Are vitals within alarm limits?. Target: Is Alarm Triggered?.

No Source: Is Alarm Triggered?. Target: triggerAlarm(device, alarm).

Yes Source: Is Alarm Triggered?. Target: getPhysData(vitals).

Begin Patient Monitoring Database: <none>, Stereotype: «StartEvent», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Begin Patient Monitoring. Target: setISData(baseLine vitals).

getISData(patientID, EMR, Labs) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 11/10/2011. Notes: Query EMR - and - Query for Labs Where does this come from? What values are important from labs? What do you need specifically. Is any pending labs? from Order System How old is this lab available? When is it pending? What is the expiration on lab values? Data Attributes

Name Type Notes EMR String Labs String Patient ID String


Begin 5R process. Target: getISData(patientID, EMR, Labs).

Source: getISData(patientID, EMR, Labs). Target: getOrders(patientID).

getObservationData(5RDrugCheck) Database: C++, Stereotype: «BusinessProcess», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: 5R Drug Administration Check Connections Name Association Notes Source:

setSettings(infusionPump). Target: getObservationData(5RDrugCheck).

Source: getObservationData(5RDrugCheck). Target: Does the Patient Require Monitoring with this Infusion.

BPMN 1.1 diagram: 5R Drug Administration

compare: identifyPatient() to getOrders(patientID) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

compare: identifyPatient() to getOrders(patientID). Target: compare: infusionPump.getDrug() to getOrders().

Source: identifyPatient(). Target: compare: identifyPatient() to getOrders(patientID).

compare: infusion.getLastInfusion(time) to getOrders(infusionRate) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Verify Drug Administration is Within Acceptable Time Connections Name Association Notes Source:

compare: infusionPump.getDose() to getOrders(drugDose). Target: compare: infusion.getLastInfusion(time) to getOrders(infusionRate).

Source: compare: infusion.getLastInfusion(time) to getOrders(infusionRate). Target: compare: infusionPump.getDrugRoute() to getOrders(drugRoute).

compare: infusionPump.getDose() to getOrders(drugDose) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/26/2011. Notes: Connections Name Association Notes Source:

compare: infusionPump.getDrug() to getISData(currentMedications). Target: compare: infusionPump.getDose() to getOrders(drugDose).

Source: compare: infusionPump.getDose() to getOrders(drugDose). Target: compare: infusion.getLastInfusion(time) to getOrders(infusionRate).

compare: infusionPump.getDrug() to getISData(allergies) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

compare: infusionPump.getDrug() to getOrders(). Target: compare: infusionPump.getDrug() to getISData(allergies).

Source: compare: infusionPump.getDrug() to getISData(allergies). Target: compare: infusionPump.getDrug() to getISData(currentMedications).

compare: infusionPump.getDrug() to getISData(currentMedications) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

compare: infusionPump.getDrug() to getISData(allergies). Target: compare: infusionPump.getDrug() to getISData(currentMedications).

Source: compare: infusionPump.getDrug() to getISData(currentMedications). Target: compare: infusionPump.getDose() to getOrders(drugDose).

compare: infusionPump.getDrug() to getOrders() Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

compare: infusionPump.getDrug() to getOrders(). Target: compare: infusionPump.getDrug() to getISData(allergies).

Source: compare: identifyPatient() to getOrders(patientID). Target: compare: infusionPump.getDrug() to getOrders().

compare: infusionPump.getDrugRoute() to getISData(routeCompatability)

Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/26/2011. Notes: Connections Name Association Notes Source:

compare: infusionPump.getDrugRoute() to getOrders(drugRoute). Target: compare: infusionPump.getDrugRoute() to getISData(routeCompatability).

Source: compare: infusionPump.getDrugRoute() to getISData(routeCompatability). Target: 5R Complete .

compare: infusionPump.getDrugRoute() to getOrders(drugRoute) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/26/2011. Notes: Connections Name Association Notes Source:

compare: infusion.getLastInfusion(time) to getOrders(infusionRate). Target: compare: infusionPump.getDrugRoute() to getOrders(drugRoute).

Source: compare: infusionPump.getDrugRoute() to getOrders(drugRoute). Target: compare: infusionPump.getDrugRoute() to getISData(routeCompatability).

identifyPatient() Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Scan Patient ID Badge - and - Verify Patient ID - and - Verify Patient ID matches Order Data Attributes Name Type Notes patientID String


identifyPatient().

Name Association Notes Target: compare: identifyPatient() to getOrders(patientID).

Source: getOrders(patientID). Target: identifyPatient().

5R Complete Database: <none>, Stereotype: «EndEvent», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

compare: infusionPump.getDrugRoute() to getISData(routeCompatability). Target: 5R Complete .

Begin 5R process Database: <none>, Stereotype: «StartEvent», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

Begin 5R process. Target: getISData(patientID, EMR, Labs).

getObservationData(nurseCheck) Database: <none>, Stereotype: «BusinessProcess», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes: Periodic Nursing Check - This is an additional process that occurs at a regular interval of generally

4 hours but can be as frequent as every 5 minutes if the patient is critical and/or unstable. Connections Name Association Notes Source:

getObservationData(nurseCheck). Target: Continue Infusion.

Source: Patient Infusion Process (in parallel). Target: getObservationData(nurseCheck).

BPMN 1.1 diagram: Periodic Nursing Check

compare: getISData(painScore, sedationScore) to getPhysData(painScore, sedationScore) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

compare: getISData(painScore, sedationScore) to getPhysData(painScore, sedationScore). Target: Change in score.

No Source: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR). Target: compare: getISData(painScore, sedationScore) to getPhysData(painScore, sedationScore).

compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

getPhysData(patientID, vitals). Target: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR).

No Source: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR). Target: <anonymous>.

Yes Source: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR). Target: manualProcess: Complete Physician notification process.

compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes


getISData(painScore, sedationScore). Target: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR).

No Source: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR). Target: compare: getISData(painScore, sedationScore) to getPhysData(painScore, sedationScore).

manualProcess: Complete Physician notification process Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 6/1/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

manualProcess: Complete Physician notification process. Target: Continue.

Yes Source: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR). Target: manualProcess: Complete Physician notification process.

manualProcess: Complete Physician notification process Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 6/1/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

manualProcess: Complete Physician notification process. Target: manualProcess: Repeat every 1 hr.

manualProcess: Repeat every 1 hr Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 6/1/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

manualProcess: Repeat every 1 hr. Target: <anonymous>.


manualProcess: Complete Physician notification process. Target: manualProcess: Repeat every 1 hr.

Yes Source: Change in score. Target: manualProcess: Repeat every 1 hr.

manualProcess: Repeat every 4 hrs Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 6/1/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

manualProcess: Repeat every 4 hrs. Target: <anonymous>.

No Source: Change in score. Target: manualProcess: Repeat every 4 hrs.

setOrders(patientID) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 8/14/2012. Notes: Data Attributes Name Type Notes careOrders String patientID String


setOrders(patientID). Target: complete Physician Order.

No Source: Continue. Target: setOrders(patientID).

Change in score Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes


compare: getISData(painScore, sedationScore) to getPhysData(painScore, sedationScore). Target: Change in score.

No Source: Change in score. Target: manualProcess: Repeat every 4 hrs.

Yes Source: Change in score. Target: manualProcess: Repeat every 1 hr.

Continue Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 6/1/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

manualProcess: Complete Physician notification process. Target: Continue.

No Source: Continue. Target: setOrders(patientID).

Yes Source: Continue. Target: <anonymous>.

complete Physician Order Database: <none>, Stereotype: «EndEvent», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

setOrders(patientID). Target: complete Physician Order.

getOrders(patientID) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes: Data Attributes Name Type Notes

medicationOrders String Patient ID Integer


Begin Infusion Management. Target: getOrders(patientID).

Source: Start Monitoring Setup. Target: getOrders(patientID).

Source: getOrders(patientID). Target: manualProcess: Setup Monitoring Equipment.

Source: getOrders(patientID). Target: identifyPatient().

Source: getISData(patientID, EMR, Labs). Target: getOrders(patientID).

Source: getOrders(patientID). Target: setObservationData(IVassessment).

Activity Database: <none>, Stereotype: , Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 3/24/2011. Notes:

getPhysData(patientID, vitals) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 11/10/2011. Notes: capture vital signs This is values look at right now, this is a snap shot of the vitals right now. Data Attributes Name Type Notes Blood Pressure Integer Heart Rate Integer Patient ID String SpO2 Integer Temperature Integer


<anonymous>. Target:

Name Association Notes getPhysData(patientID, vitals).

Source: getPhysData(patientID, vitals). Target: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR).

manualProcess: Administer Infusion Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes: Administer Infusion

manualProcess: Bolus Infusion Administered by Patient (If PCA) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes:

manualProcess: Pump/Line Removal Process Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 7/15/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

manualProcess: Pump/Line Removal Process. Target: End Infusion Therapy Process.

No, End Infusion Source: Continue Infusion. Target: manualProcess: Pump/Line Removal Process.

setObservationData(IVassessment) Database: <none>, Stereotype: «BusinessProcess», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Complete IV Assessment This values may be useful for decision support later and should be documented. Body site values will be useful for protocols. May be useful for decision support. Hospitals generally have a selection list and we should check SNOMED CT for standards. Connections Name Association Notes Source:

getOrders(patientID). Target: setObservationData(IVassessment).

Source: setObservationData(IVassessment). Target:

Name Association Notes Infusion Pump PreSetup.

BPMN 1.0 diagram: IV Assessment

setObservationData(IVLines) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Data Attributes Name Type Notes Body Site String Dressing Change Frequency String Gauge Integer Line Tubing Change Frequency String Line Type String Site Assessment String


Assessment Complete. Target: setObservationData(IVLines).

Continue with Assessment Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Site Assessment. Target: Continue with Assessment.

Source: Continue with Assessment. Target: Begin Assessment.

Source: Continue with Assessment. Target: Assessment Complete.

Arterial, Central Venous, Pulmonary Artery, PIC Database: <none>, Stereotype: «information», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Line Types. Target: Arterial, Central Venous, Pulmonary Artery, PIC.

Arterial: Radial/Femoral, Right/Left. Central Venous: Internal Jugular/Subclavian, Right/Left. Pulmonary Artery: (Not) Paced, Internal Jugular/Subclavian, Right/Left. PIC: Right/Left Database: <none>, Stereotype: «information», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Body Site. Target: Arterial: Radial/Femoral, Right/Left. Central Venous: Internal Jugular/Subclavian, Right/Left. Pulmonary Artery: (Not) Paced, Internal Jugular/Subclavian, Right/Left. PIC: Right/Left.

Frequency, Time of Next Change Database: <none>, Stereotype: «information», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Line Tubing Change. Target: Frequency, Time of Next Change.

Frequency, Time of Next Change Database: <none>, Stereotype: «information», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Dressing Change. Target: Frequency, Time of Next Change.

Assessment Complete Database: <none>, Stereotype: «IntermediateEvent», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Assessment Complete. Target: setObservationData(IVLines).


Continue with Assessment. Target: Assessment Complete.

Begin Assessment Database: <none>, Stereotype: «StartEvent», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 2/8/2012. Notes: Connections Name Association Notes Source:

Begin Assessment. Target: Line Types.

Source: Continue with Assessment. Target: Begin Assessment.

Body Site Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Line Types. Target: Body Site.

Source: Body Site. Target: Gauge.

Source: Body Site. Target: Arterial: Radial/Femoral, Right/Left. Central Venous: Internal Jugular/Subclavian, Right/Left. Pulmonary Artery: (Not) Paced, Internal Jugular/Subclavian, Right/Left. PIC: Right/Left.

Dressing Change Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Name Association Notes Gauge. Target: Dressing Change.

Source: Dressing Change. Target: Line Tubing Change.

Source: Dressing Change. Target: Frequency, Time of Next Change.

Gauge Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Gauge. Target: Dressing Change.

Source: Body Site. Target: Gauge.

Line Tubing Change Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Dressing Change. Target: Line Tubing Change.

Source: Line Tubing Change. Target: Number of Attempts.

Source: Line Tubing Change. Target: Frequency, Time of Next Change.

Line Types Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes:


Line Types. Target: Body Site.

Source: Line Types. Target: Arterial, Central Venous, Pulmonary Artery, PIC.

Source: Begin Assessment. Target: Line Types.

Number of Attempts Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Number of Attempts. Target: Site Assessment.

Source: Line Tubing Change. Target: Number of Attempts.

Site Assessment Database: Java, Stereotype: , Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Site Assessment. Target: Continue with Assessment.

Source: Number of Attempts. Target: Site Assessment.

setSettings(infusionPump) Database: <none>, Stereotype: «BusinessProcess», Package: Infusion Therapy Detail: Created on 3/25/2011. Last modified on 7/15/2011. Notes: Setup Infusion Connections


Infusion Pump PreSetup. Target: setSettings(infusionPump).

Source: setSettings(infusionPump). Target: getObservationData(5RDrugCheck).

BPMN 1.1 diagram: Setup Infusion

getISData(painScore, sedationScore) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 11/10/2011. Notes: Collect/Compare Pain and Sedation Score Where is this stored? If we want software to make decisions .....this may be requested or queried from flow sheet. This should also be sent to update nursing flow sheet

Data Attributes Name Type Notes painScore Integer sedationScore Integer


getISData(painScore, sedationScore). Target: manualProcess: Educate Patient and Family on PCA.

Source: <anonymous>. Target: getISData(painScore, sedationScore).

Source: getISData(painScore, sedationScore). Target: compare: getPhysData(SysNIBP, RR, HR) to getSettings(monitor, NIBP, RR, HR).

Yes Source: PCA?. Target: getISData(painScore, sedationScore).

getISData(patientHazards) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 11/10/2011. Notes: Check Patient Hazards - This is risks associated with specific drugs. For PCA this includes to

check the EMR (previously queried for Benzodiazaphines, Anxiolytes and or Sleep Apnea, or if the patient is diagnosed with morbid Obesity. Currently this process is completed manually. This workflow will show specific harzards for PCA but these will vary.

Data Attributes Name Type Notes patientHazards String


manualProcess: Educate Patient and Family on PCA. Target: getISData(patientHazards).

Source: getISData(patientHazards). Target: manualProcess: Load Tubing/Cassette Into Pump.

No Source: PCA?. Target: getISData(patientHazards).

Volumetric Source: Select Infusion Pump Type?. Target: getISData(patientHazards).

manualProcess: Educate Patient and Family on PCA Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Educate Patient and Family on PCA Connections Name Association Notes Source:

getISData(painScore, sedationScore). Target: manualProcess: Educate Patient and Family on PCA.

Source: manualProcess: Educate Patient and Family on PCA. Target: getISData(patientHazards).

manualProcess: Load Tubing/Cassette Into Pump Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

getISData(patientHazards). Target: manualProcess: Load Tubing/Cassette Into Pump.

Source: manualProcess: Load Tubing/Cassette Into Pump. Target: setSettings(infusionPump).

setSettings(infusionPump) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 11/10/2011. Notes: This process varies from pump to pump Must set Rate/Dosage/Time/Bolus/Time Out List Pump Settings Here! What is the minimum set of settings What is the entire list of settings If any parameters the units associated Lock out intervals settings Data Attributes Name Type Notes Bolus Integer Dose Integer Pump Rate Integer Pump Time Integer Pump Time Out Integer

Connections Name Association Notes


manualProcess: Load Tubing/Cassette Into Pump. Target: setSettings(infusionPump).

Source: setSettings(infusionPump). Target: End Setup.

Manual Infusion or with Infusion Pump? Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Infusion Pump Source:

Manual Infusion or with Infusion Pump?. Target: Select Infusion Pump Type?.

PCA? Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes No Source:

PCA?. Target: getISData(patientHazards).

Syringe Source: Select Infusion Pump Type?. Target: PCA?.

Yes Source: PCA?. Target: getISData(painScore, sedationScore).

Select Infusion Pump Type? Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Infusion Pump Source:

Manual Infusion or with Infusion Pump?. Target: Select Infusion Pump Type?.

Name Association Notes Syringe Source:

Select Infusion Pump Type?. Target: PCA?.

Volumetric Source: Select Infusion Pump Type?. Target: getISData(patientHazards).

End Setup Database: <none>, Stereotype: «EndEvent», Package: Infusion Therapy Detail: Created on 3/28/2011. Last modified on 7/18/2011. Notes: Connections Name Association Notes Source:

setSettings(infusionPump). Target: End Setup.

setSettings(monitor) Database: <none>, Stereotype: «BusinessProcess», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes: Setup Patient Monitoring Connections Name Association Notes Source:

setSettings(monitor). Target: Patient Infusion Process (in parallel).

Source: setSettings(monitor). Target: Monitor Patient.

Yes Source: Does the Patient Require Monitoring with this Infusion. Target: setSettings(monitor).

BPMN 1.1 diagram: Setup Patient Monitoring

Capnograph Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Select one or both device(s). Target: Capnograph.

Source: Capnograph. Target: manualProcess: Attach Sensors to Patient.

manualProcess: Attach Sensors to Patient Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/30/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

Capnograph. Target: manualProcess: Attach Sensors to Patient.

Source: Pulse Oximeter. Target: manualProcess: Attach Sensors to Patient.

Source: manualProcess: Attach Sensors to Patient. Target: setSettings(device).

manualProcess: Setup Monitoring Equipment Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/30/2011. Last modified on 7/15/2011. Notes: Plug in, turn on Connections Name Association Notes Source:

getOrders(patientID). Target: manualProcess: Setup Monitoring Equipment.

Source: manualProcess: Setup Monitoring Equipment. Target:

Name Association Notes Select one or both device(s).

Pulse Oximeter Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

Select one or both device(s). Target: Pulse Oximeter.

Source: Pulse Oximeter. Target: manualProcess: Attach Sensors to Patient.

setAlarmSettings(device) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 3/30/2011. Last modified on 8/14/2012. Notes: Program Alarm Limits Data Attributes Name Type Notes Pulse Rate high limit Integer Pulse Rate low limit Integer Respiratory Rate high limit Integer Respiratory Rate low limit Integer SpCO2 high limit Integer SpCO2 low limit Integer SpO2 high limit Integer SpO2 low limit Integer


setAlarmSettings(device). Target: End Monitoring Setup.

Source: setSettings(device). Target: setAlarmSettings(device).

setSettings(device) Database: <none>, Stereotype: «Activity», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Data Attributes Name Type Notes date String screenBrightness String

time String volume Integer


setSettings(device). Target: setAlarmSettings(device).

Source: manualProcess: Attach Sensors to Patient. Target: setSettings(device).

Select one or both device(s) Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 8/13/2012. Last modified on 8/13/2012. Notes: Connections Name Association Notes Source:

manualProcess: Setup Monitoring Equipment. Target: Select one or both device(s).

Source: Select one or both device(s). Target: Capnograph.

Source: Select one or both device(s). Target: Pulse Oximeter.

End Monitoring Setup Database: <none>, Stereotype: «EndEvent», Package: Infusion Therapy Detail: Created on 3/30/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

setAlarmSettings(device). Target: End Monitoring Setup.

Start Monitoring Setup Database: <none>, Stereotype: «StartEvent», Package: Infusion Therapy Detail: Created on 3/30/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes


Start Monitoring Setup. Target: getOrders(patientID).

Begin Infusion Management Database: <none>, Stereotype: «StartEvent», Package: Infusion Therapy Detail: Created on 3/23/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

Begin Infusion Management. Target: getOrders(patientID).

End Infusion Therapy Process Database: <none>, Stereotype: «EndEvent», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 3/24/2011. Notes: Connections Name Association Notes Source:

manualProcess: Pump/Line Removal Process. Target: End Infusion Therapy Process.

Continue Infusion Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

getObservationData(nurseCheck). Target: Continue Infusion.

No, End Infusion Source: Continue Infusion. Target: manualProcess: Pump/Line Removal Process.

Yes Source: Continue Infusion. Target: Patient Infusion Process (in parallel).

Does the Patient Require Monitoring with this Infusion Database: <none>, Stereotype: «Gateway», Package: Infusion Therapy Detail: Created on 3/24/2011. Last modified on 7/15/2011. Notes: Connections Name Association Notes Source:

getObservationData(5RDrugCheck). Target: Does the Patient Require Monitoring with this Infusion.

No Source: Does the Patient Require Monitoring with this Infusion. Target: Patient Infusion Process (in parallel).

Yes Source: Does the Patient Require Monitoring with this Infusion. Target: setSettings(monitor).

Diagram: Primary Use Case

Timing Diagram: Infusion Therapy

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