Canadian Patents Database / Patent 2514571 Summary

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(12) Patent: (11) CA 2514571
(54) English Title: WIRELESS MEDICAL DATA COMMUNICATION SYSTEM AND METHOD
(54) French Title: SYSTEME ET PROCEDE DE COMMUNICATION DE DONNEES MEDICALES SANS FIL
(51) International Patent Classification (IPC):
  • H04W 24/00 (2009.01)
  • G16H 20/17 (2018.01)
  • G16H 40/60 (2018.01)
  • A61M 5/142 (2006.01)
  • G06F 19/00 (2011.01)
(72) Inventors :
  • SIMPSON, THOMAS L. (United States of America)
  • LETELLIER, LAURA M. (United States of America)
  • MARTUCCI, JAMES P. (United States of America)
(73) Owners :
  • BAXTER INTERNATIONAL INC. (Not Available)
(71) Applicants :
  • BAXTER INTERNATIONAL INC. (United States of America)
(74) Agent: MARKS & CLERK
(74) Associate agent:
(45) Issued: 2019-01-15
(86) PCT Filing Date: 2004-01-30
(87) Open to Public Inspection: 2004-08-19
Examination requested: 2009-01-07
(30) Availability of licence: N/A
(30) Language of filing: English

(30) Application Priority Data:
Application No. Country/Territory Date
60/444,350 United States of America 2003-02-01
10/424,553 United States of America 2003-04-28
60/488,273 United States of America 2003-07-18
10/659,760 United States of America 2003-09-10
60/528,106 United States of America 2003-12-08

English Abstract


A system and method is disclosed for executing at least one of an alarm or an
alert escalation process within a
healthcare environment.



French Abstract

La présente invention a trait à un système et un procédé pour l'exécution d'au moins une procédure d'indexation d'avertissement ou d'alerte dans un environnement de soins de santé.


Note: Claims are shown in the official language in which they were submitted.

129
What is claimed is:
1. A system for reporting on integrity of a wireless communication link
within a
healthcare facility comprising:
a wireless remote device within the healthcare facility having a message
indicator responsive to status information transmitted over the wireless
communication
link, the status information representative of a signal generated by a
medication
treatment application device,
wherein the wireless remote device includes an application, which when
executed, causes the wireless remote device to test an integrity of the
wireless
communication link by:
(a) periodically polling the wireless communication link,
(b) determining that a loss of the wireless communication link has
occurred by detecting that a response to the polling has not been received
within a certain
amount of time, and
(c) providing a time-out output that (i) indicates the loss of the wireless
communication link and (ii) indicates that the status information from the
medication
treatment application device is not current,
wherein the periodic polling occurs regardless of whether the loss of the
wireless communication link is determined.
2. The system of claim 1 further comprising a module associated with the
medication treatment application device, the module having the status
information output
responsive to the signal output generated by the medication treatment
application device.
3. The system of claim 2 wherein the association between the module and the

medication treatment application device results in at least some data within
the status
information output passing through the module.
4. The system of any one of claims 1 to 3 wherein the medication treatment
application device is an infusion pump for administering an infusion to a
patient.
5. The system of any one of claims 1 to 4 wherein the signal output
generated by
the medication treatment device is a notification.

130
6. The system of claim 5 wherein the notification comprises data relating
to at least
one of an alarm condition, an alert condition, an infusion volume rate and a
time
rernaining before an infusion bag is emptied.
7. The system of any one of claims 1 to 6 wherein the wireless remote
device is a
personal digital assistant.
8. The system of any one of claims 1 to 7 wherein the wireless
communication link
operates within a radio frequency.
9. The system of any one of claims 1 to 4 wherein the message indicator
comprises
at least one of an audible alarm and a visual display.
10. The system of clairn 9 wherein the audible alarm produces an audible
sound in
response to the time-out output.
11. The systern of claim 9 or 10 wherein an icon responsive to the time-out
output is
provided on the visual display.
12. The system of any one of claims 9 to 11 wherein a notification is
provided on the
visual display in response to the time-out output, the notification indicating
that the
status information from the medication treatment application device is not
current.
13. The systern of any one of claims 1 to 12 wherein the application is
configured to
test the integrity of the wireless communication link by periodically polling
a central
system via the wireless communication link.
14. The system of claim 13 wherein the wireless rernote device is further
configured
to download the application from a server communicatively coupled to the
medication
treatment application device.
15. A system for reporting on integrity of a wireless communication link
within a
healthcare facility comprising:
a wireless remote device within the healthcare facility having a message
indicator responsive to status information transmitted over the wireless
communication
link, the status information representative of a signal generated by a
medication
treatrnent application device,

131
wherein the wireless remote device includes an application, which when
executed, causes the wireless remote device to test an integrity of the
wireless
communication link by:
(a) periodically polling the wireless communication link,
(b) determining that a loss of the wireless communication link has
occurred by detecting that a response to the polling has not been received
within a certain
amount of time, and
(c) providing a time-out output that (i) indicates the loss of the wireless
communication link and (ii) indicates that the status information from the
medication
treatment application device is not current,
wherein the periodic polling occurs even after the loss of the wireless
communication link is determined.

Note: Descriptions are shown in the official language in which they were submitted.

CA 02514571 2012-06-08
WIRELESS MEDICAL DATA COMMUNICATION
SYSTEM AND METHOD
DESCRIPTION
10
20
TECHNICAL FIELD
This invention relates generally to wireless medical data communication
systems and
methods. More particularly, the present invention relates to a system and
method for reporting
on the integrity of a wireless communication link.
BACKGROUND OF THE INVENTION
Patient care systems typically include computer networks, medical devices for
treating a
patient, and controls for the medical devices. Although patient care systems
have improved
through the use of computerized automation systems and methods, patient care
systems
continue to rely heavily upon manual data management processes for medical
devices and
controls for medical devices. For example, nursing stations are typically
connected to the

CA 02514571 2016-11-30
2
computer networks in modern hospitals, but it is unusual for the computer
network to extend to a
patient's room. Computer networks offer the opportunity for automated data
management
processing including the operating and monitoring of medical devices and
controls for the medical
devices at the point-of-care. Despite advances in the field, automated data
management
technology has been underutilized for point-of-care applications due to a lack
of more efficient
systems and methods. As dependance on automated technology grows, a need also
grows in
providing users with the ability to determine the operating status of system
or subsystems.
SUMMARY OF THE INVENTION
The present invention provides a system and method for reporting on the
integrity of a
wireless communication link within a healthcare facility.
Generally, the present invention includes a system having a medication
administration
module and a wireless remote device located within a healthcare facility. The
medication
administration module is associated with the medication treatment application
device, such as an
infusion pump. The wireless remote device includes a message indicator, such
as a visual display
or an audible alarm, that is responsive to a status information output
generated by the medication
administration module and transmitted over a wireless communication link. The
wireless remote
device also includes a module or application for generating a time-out when
the wireless
communication link is lost.
Accordingly, in one aspect there is provided a system for reporting on
integrity of a
wireless communication link within a healthcare facility comprising: a
wireless remote device
within the healthcare facility having a message indicator responsive to status
information
transmitted over the wireless communication link, the status information
representative of a signal
generated by a medication treatment application device, wherein the wireless
remote device
includes an application, which when executed, causes the wireless remote
device to test an
integrity of the wireless communication link by: (a) periodically polling the
wireless
communication link, (b) determining that a loss of the wireless communication
link has occurred
by detecting that a response to the polling has not been received within a
certain amount of time,
and (c) providing a time-out output that (i) indicates the loss of the
wireless communication link
and (ii) indicates that the status information from the medication treatment
application device is
not current, wherein the periodic polling occurs regardless of whether the
loss of the wireless
communication link is determined.

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2a
BRIEF DESCRIPTION OF THE DRAWINGS
The invention can be better understood with reference to the following
drawings. The
components in the drawings are not necessarily to scale, emphasis instead
being placed upon clearly
illustrating the principles of the present invention. In the drawings, like
reference numerals designate
s corresponding parts throughout the several views.
FIGURE 1 is a simplified graphical representation of a patient care system.
The patient care
system includes a pharmacy computer, a central system, and a digital assistant
at a treatment location;

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FIGURE 2 is a block diagram of a computer system representative of the
pharmacy
computer, the central system, and/or the digital assistant of FIGURE 1. The
system includes an
infusion system or a portion thereof;
FIGURE 3 is a simplified graphical representation of portions of the patient
care system
of FIGURE 1;
FIGURE 4 is a block diagram showing functional components of the patient care
system
of FIGURE 1;
FIGURE 5 is an exemplar computer screen for implementing various functions of
the
patient care system of FIGURE 1;
FIGURE 6 is a block diagram showing functional components of the infusion
system of
FIGURE 2. The functional components include, inter alia, blocks for setting
infusion system
parameters, infusion order creation, infusion order preparation, medication
administration,
infusion order modifications, and messaging;
FIGURE 7 is a block diagram showing functional components for the setting of
infusion
system parameters of FIGURE 6;
FIGURE 8 is a block diagram showing functional components for the infusion
order
creation of FIGURE 6;
FIGURE 9 is a block diagram showing functional components for the infusion
order
preparation of FIGURE 6;
FIGURE 10 is a block diagram showing functional components for the medication
administration of FIGURE 6;
FIGURE 11 is a block diagram showing functional components for infusion order
documentation, infusion order modifications, and messaging of FIGURE 6;
FIGURE 12 is a view of an emergency notification system, illustrating
communication;
FIGURE 13 is a view of an emergency notification interface from the
perspective of a
notifying party, illustrating the preferred notification options made
available to the notifying
party by the emergency notification system;
FIGURE 14 is a view of an emergency notification interface from the
perspective of a
target party, illustrating the preferred emergency information received by the
target party;
FIGURE 15 is one embodiment of a flowchart of an alarm/alert escalation
process;
FIGURE 16a is a view of an alarm/alert interface screen;
FIGURE 16b is another view of an alarm/alert interface screen;
FIGURE 17 is another view of an alaim/alert interface screen;
FIGURE 18 is a view of an interface screen from the clinician's handheld
device;

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FIGURE 19 is a view of an interface screen of a login process;
FIGURE 20 is a view of another interface screen of the login process of FIGURE
19;
FIGURE 21 is a view of a unit selection interface screen;
FIGURE 22 is a view of a shift selection interface screen;
FIGURE 23 is a view of a patient view interface screen;
FIGURE 24 is a view of a patient selection interface screen;
FIGURE 25 is a view of a patient information menu interface screen;
FIGURE 25a is a view of an allergies and height/weight interface screen;
FIGURE 25b is a view of a medication history interface screen;
FIGURE 25c is a view of a lab results interface screen;
FIGURE 26 is a view of a medication delivery schedule interface screen;
FIGURE 27 is another view of an interface screen of the medication delivery
schedule
process of FIGURE 26;
FIGURE 27a is a view of an interface screen of a workflow infusion stop;
FIGURE 27b is another view of an interface screen of a workflow infusion stop;
FIGURE 27c is a view of an interface screen of a workflow to resume an
infusion;
FIGURE 28 is another view of an interface screen of the medication delivery
schedule
process of FIGURE 26;
FIGURE 29 is a view of a missed medication interface screen;
FIGURE 30 is another view of the interface screen of FIGURE 29;
FIGURE 31 is another view of the interface screen of FIGURE 29;
FIGURE 32 is a view of a schedule interface screen;
FIGURE 33 is a view of a medication interface screen;
FIGURE 34 is a view of a scan interface screen;
FIGURE 35 is a view of another scan interface screen;
FIGURE 36 is a view of a medication administration interface screen;
FIGURE 37 is a view of a route verification interface screen;
FIGURE 38 is a view of a scan pump channel interface screen;
FIGURE 38a is a view of another scan pump channel interface screen;
FIGURE 39 is a view of a comparison interface screen;
FIGURE 39a is another view of a comparison interface screen;
FIGURE 40 is another view of a comparison interface screen;
FIGURE 41 is another view of a comparison interface screen;
FIGURE 42 is another view of a comparison interface screen;

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FIGURE 43 is a view of a pump status interface screen;
FIGURE 44 is a view of a flow rate history interface screen;
FIGURE 45a is a view of a communication loss interface screen;
FIGURE 45b is a view of a communication loss interface screen;
5 FIGURE 46 is a view of a low battery interface screen;
FIGURE 47 is a view of a hub;
FIGURE 48 is a view of a variety of icons utilized in the interface screens;
FIGURE 49 is a view of a record administration results interface screen;
FIGURE 50 is a view of a medication order having a monitoring parameter link;
FIGURE 50a is a view of a monitoring parameter entry interface screen;
FIGURE 51 is a view of a cycle count interface screen;
FIGURE 52 is a flowchart of an order comparison process;
FIGURE 53 is a schematic diagram of a flow control system where a micro-
electromechanical system (MEMS) element is connected to a line set;
FIGURE 54 is a simplified block diagram of software components loaded on the
first
central computer of FIGURE 3;
FIGURE 55A ¨ FIGURE 55C is a flowchart of an example administer infusion
process;
FIGURE 56 is a flowchart of an example channel scanning process;
FIGURE 57A ¨ FIGURE 57B is a flowchart of an example change pump channel
process;
FIGURE 58 is a flowchart of another example channel scanning process;
FIGURE 59 is a flowchart of yet another example channel scanning process;
FIGURE 60 is a flowchart of an example stop/discontinue infusion process;
FIGURE 61 is a flowchart of an example resume infusion process;
FIGURE 62 is a flowchart of an example remove pump process; and,
FIGURE 63 ¨ FIGURE 69 is a flowchart of an example authentication process.
DETAILED DESCRIPTION
While this invention is susceptible of embodiments in many different forms,
there is
shown in the drawings and will herein be described in detail a preferred
embodiment of the
invention. The present disclosure is to be considered as an exemplification of
the principles of
the invention and is not intended to limit the broad aspect of the invention
to the embodiment
illustrated.
FIGURE 1 is a graphical representation of a patient care system. In one
embodiment,

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the patient care system 100 includes a pharmacy computer 104, a central system
108, and a
treatment location 106, linked by a network 102. The patient care system 100
also includes an
infusion system 210, also referred to as a healthcare system, as shown in
FIGURE 2. Infusion
system 210 is a medication system preferably implemented as a computer
program, and in
particular a module or application (i.e., a program or group of programs
designed for end users),
resident on one or more electronic computing devices within the patient care
system 100. As
described in detail further herein, the infusion system 210 links clinicians,
such as physicians,
pharmacists, and nurses, in an interdisciplinary approach to patient care.
Overall System
Turning to FIGURE 3, the patient care system 100 can include a plurality of
medical
devices 120. In one embodiment, the medical device is an infusion pump 120.
Further, in
another embodiment the medical device is a controller for an infusion pump.
For ease of
reference, this disclosure will generally identify the medical device of the
system as an infusion
pump, however, it is understood that the overall system 100 may incorporate
any one or more of
a variety of medical devices. Accordingly, as shown in FIGURE 3, a plurality
of infusion
pumps 120 are connected to a hub or interface 107. As explained in detail
further herein, the
infusion pumps 120 can be of conventional design wherein each infusion pump
120 is
associated with a patient. However, as will be appreciated by those having
ordinary skill in the
art, the infusion pumps 120 shown in FIGURE 3 do not have to be associated
with the same
patient or treatment location even though the infusion pumps are connected to
the same hub
107. Moreover, each infusion pump 120 can be a single channel pump or a
multiple channel
pump, such as a triple channel pump. Any such channel is identified with
reference number
121. Typically, the pumps transmit messages containing pump status information
on a periodic
basis to the hub 107. A separate hub 107 can be used apart from the medical
device 120 in
order to centralize communications, for cost efficiencies, and/or to allow for
retrofitting of
existing medical devices that do not currently communicate with a central
computer system 108
so that each such medical device can communicate with a central computer
system 108.
Communication Hubs of the Overall System
In an embodiment, the serial port or other I/0 port of the infusion pumps 120
is
connected to the hub 107 using a conventional non-wireless transmission medium
105 such as
twisted-pair wire, coaxial cable, fiber optic cable, or the like. Preferably,
the hub 107 can
connect to a plurality of infusion pumps 120 or just a single pump, through a
one-way serial
communications link 105. The hub 107 provides for receiving signals from the
connected
pumps and regenerating the received signals. In particular, the received
signals from the pumps

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.120 are converted by the hub 107 into a format suitable for transmission onto
the system
network 102 via wireless communication path or link 128 and cable
communication system
110. Typically, the hub 107 sends pump data to the system network 102. The hub
107 may
also filter incoming information from the pumps 120 to reject duplicate
messages.
Additionally, the hub 107 allows pump status information to be viewed remotely
on a
clinician's 116 digital assistant 118. Typically, the hub 107 sends pump data
whenever the hub
107 is connected to the pump 120 and both the hub 107 and the pump 120 are
turned on. As
explained in detail herein, the hub 107 also provides for allowing comparisons
of pharmacy-
entered orders to the pump settings. In a preferred embodiment, the hub 107 is
connected to the
IV pole holding the pumps 120, or the hub 107 is incorporated into the
infusion pump 120 to
create an integrated medical/communications device as identified above.
One embodiment of a hub 107 is shown in FIGURE 47. In this embodiment, the hub

107 includes pump port indicators 411 for up to 4 pumps, a loss of wireless
signal indicator
413, a low battery indicator 415, an alert mute key 417, an on/off key and
indicator 419, and a
charging indicator 421. The pump port indicators 411 provide a status
indicator for each of the
hub's 107 pump ports. The indicator light shows that the corresponding pump
port is properly
communicating with the network 102. When the indicator light is not lit,
however, this
indicates that the corresponding pump port is not connected to the pump 120 or
the port is not
communicating from the pump 120 to the network 102. The loss of wireless
signal indicator
413 indicates that the hub 107 cannot communicate with the network 102 over
the wireless link.
If a loss of wireless signal occurs, each of the pump port indicators 411 will
also turn off,
indicating that the hub 107 is not communicating with the network 102. If a
loss of wireless
signal occurs, the hub 107 will communicate this event to the system network
102 and the
central computer system 108 and server 109 for eventual transmission to the
clinician 116. The
alert mute key 417 allows the clinician 116 to temporarily silence all audible
alerts from the hub
107. Alternate embodiments of the communications hub include a single
dedicated wireless
module physically within the pump, or a separate module using wireless
communications to
reach both the pump and server.
Additionally, in an alternate embodiment, the hub 107 may be optionally
incorporated
into the infusion pump 120 to create an integrated medical/communications
device. The
combination hub/medical device would still function identically with respect
to each other.
Access Points of the Overall System
As shown in FIGURE 3, a plurality of access points 114 within the healthcare
facility
provides an interface between the wireless communication paths and the cable
communication

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system. Preferably, when the system network 102 is unavailable, the hub 107
stores the signals
received from the pumps 120, and then transmits the converted signals to the
system network
102 once the system network becomes available. In a preferred embodiment,
communication
between the hub 107 and the access points 114 is unidirectional from the hub
107 to the access
point 114 and ultimately the network 102. As such, in the present embodiment
the infusion
pumps 120 can transmit data to the network 102; however, the network 102
cannot transmit
data to the infusion pumps 120. It is understood, however, that in alternate
embodiments also
disclosed herein, communication between the hub 107 and the access points 114
is
bidirectional. Accordingly, in these embodiments data and other information
may be
transmitted from the network 102 to the infusion pumps 120. In either case,
the information
transmitted between the network 102 and the hubs 107 is encoded for security
purposes.
Central System Servers/ Computers of the Overall System
Referring now to FIGURES 1 and 3, the central system 108 can include one or
more
servers or computers. While this disclosure refers generally to servers 109,
108a, it is
understood that these components may be non-server computers. Preferably, but
not
necessarily, the central system 108 can include a first central server or
computer 109 and a
second central server or computer 108a. In one embodiment, a separate
communication system
103 may be provided for communication between the first central server 109 and
the second
central server 108a. In a preferred embodiment, the separate communication
system 103 is an
isolated point-to-point cable communication Ethernet network. Because this
communication
system 103 is an isolated point-to-point system connection, the data
communicated between the
two servers 109, 108a is typically not encrypted. Typically, the communication
system between
the two servers 109 and 108a allows for bi-directional communication.
As explained in detail herein, the first central server or computer 109 has a
first database
and a first functional feature set associated to data and functions related to
the medical device
and the user interface. The medical devices 120 and user interface 118
generally communicate
directly with the first central computer 109. Further, as explained in detail
herein, the second
central server or computer 108a has a second database and a second functional
feature set. The
first central computer 109 is securely connected to the second computer 108a,
and the medical
devices 120 and user interfaces 118 do not communicate directly with the
second central
computer 108a. The user interface 118 can receive data from the second
database relating to the
second functional feature set of the second central computer 108a through the
first central
computer 109.
The second central server 108a, and its software sub-system, typically
interface with a

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phaimacy system to provide information on drugs, patients and to provide the
nurses and other
clinicians with a typical workflow. The second central server 108a also
interfaces with the first
central server 109 to provide information on patients, nurses, clinicians,
orders and associations
between digital assistants 118 and clinicians. Some of the other functions of
the second central
server 108a can include patient management, item management, facility
management,
messaging, reporting/graphing, and various interfaces to other systems.
In particular, patient management refers to the general information about each
patient
that comes into a hospital or facility. This information is maintained along
with information
specific to each visit, and generally includes demographics, allergies,
admission date, discharge
date, initial diagnosis, room, bed, etc. Additionally, information about each
of the medications
which have been prescribed, scheduled, and administered is maintained by the
second central
server 108a. Functionality of the patient management function also includes
prior adverse
reaction checking, drug interaction checking, duplicate therapy checking, dose
checking and
drug-disease contraindications.
Item management refers to the information about each drug that is available in
the
facility. This information is managed and maintained within the second central
server 108a.
Such information includes drug name, strength, therapeutic classification,
manufacturer, etc.
Further, the second central server 108a maintains a perpetual inventory of the
item contents of
the medication depots and other smart storage locations on a real-time basis.
The second
central server 108a assists in providing for updates to be made as the depot
is replenished and as
doses are administered or disposed.
Facility management refers to the information that describes the overall
facility. This
information is managed and maintained within the second central server 108a of
the system
210. This information includes: a physical breakdown of the facility into
buildings, floors,
units, rooms and beds; a list of programs and services that are offered and
where they are
offered; an identification of storage units where drug and supply items are
stored and the
locations they are intended to serve.
Messaging refers to the functionality of the second central server 108a,
wherein the
second central server 108a provides a communications link between the
pharmacists and the
clinicians. The second central server 108a allows for standardization of
dosage and special
administration instructions, and automatically sends notification of missing
doses. Reporting
and graphing refers to the availability of a number of operational and
management reports
which can be run on request or on a scheduled basis by authorized users of the
system 210.
The second central server 108a also has various interfaces, such as: an ADT
interface, a

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billing interface, a discrete results interface, a documents results
interface, a fol niulary
interface, a pharmacy orders interface, a Point of Care medication management
interface and an
inventory interface. These interfaces are explained in greater detail infra,
however, a brief
explanation is provided immediately below. The ADT interface refers to the
facilities
5 admission, transfer and discharge system (ADT). This system typically
also operates the
registration of pre-admitiance and outpatients. The discrete results interface
refers to an
interface with laboratory results. Generally, after the lab results and
ancillary orders are entered
into an external lab information system, the discrete results interface or lab
interface within the
HL7 engine transfers this data to the second central server 108a. Once the lab
results are saved
10 in the second central server 108a, a user can view them from the
handheld device 118, the
Computerized Physician Order Entry (CPOE) system, and the second central
computer 108a
main application. Lab interfaces are available for at least four interfaces:
radiology lab
interface, microbiology lab interface, biochemistry lab interface, and
pathology lab interface.
These interfaces can be configured to operate either on four different ports
or on the same port.
The document results interface generally refers to the second central server
108a accepting
radiology and pathology reports. The formulary interface generally refers to
the second central
server 108a being able to accept master file notifications to synchronize an
external systems
drug file. Changes to a formulary will trigger an outbound transaction from
the server 108a to
an external third-party system. The pharmacy orders interface provides for
allowing medication
orders to be sent to external third-party systems. The inventory interface
provides for accepting
pharmacy inventory changes from external third-party systems. Additionally,
cart depot
interfaces are available with the present system 100. The second central
server 108a stores
order and drug file changes in the server database, which then sends this
information to any
third-party cart interfaces. The third-party cart interface within the HL7
engine processes this
information into HL7 MFN and RDE messages. The YfFN message contains the drug
file
information and the RDE contains the patient orders information. The HL7
engine then
transmits these messages to the third-party cart server. The HL7 engine also
receives HL7
formatted DFT messages from the third-party cart server. The DFT message
contains billing
information for medication administration. The HL7 engine processes this
information and then
sends it to the second central server 108a, which can then pass this
information to a billing
application. The billing application may then calculate patient charges and
invoice the patient.
The billing interface refers to an interface with the patient charging
software. The billing
interface supports the optional use of billing algorithms to calculate
charges. The billing
interface processes internal transactions, as well as external inbound
transactions from third-

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party systems. The billing interface provides an BiL7 interface between the
second central
server 108a and the hospital's third-party financial system. The billed
quantity may be sent
directly, or patient charges may be calculated by the billing interface to
send to the hospital's
third-party financial system. The information is sent in real-time via FIL7
messages. The Point
of Care interface consists of web service communications which integrate
information regarding
point of care medication management for non-infusion related data. These data
are
communicated in real-time in order that the user interface can integrate
medication management
for infusion related and non-infusion related medications.
Conversely, the first central server 109 has software loaded and configured
for sending
and receiving data to and from multiple hubs 107, multiple digital assistants
or user interfaces
118, and with the second central server 108a. As explained in detail below,
the first central
server 109 may perform several functions, including, but not limited to:
comparing prescription
parameters as received from server 108a to the applicable programmed pump
settings received
from the hub 107 system; relaying notifications and messages to the digital
assistants 118;
relaying alarm and alert information received from the hub 107 system to the
appropriate digital
assistant 118; relaying pharmacy and patient information as communicated from
the server 108a
to the appropriate digital assistant 118; and compiling pump status and alarm
monitoring data
and relaying this data to server 108a on a periodic basis. If required, the
operations perfotmed
by the server 109 are compliant with the Health Insurance Portability Act of
1996 (August 21),
Public Law 104-191. Typically, the data resident in the first central computer
or server 109 is
an intersection with the data resident in the second central computer or
server 108a. Server 109
contains a subset of the data contained in server 108a that is required to
perform its
functionality. Server 109 also contains data relating to the system network
102, hubs 107 and
infusion pumps 120 that are required to perform its functionality. As
explained above, such
data is generally that data required for the functions or performance of the
digital assistants 118
and medical devices 120.
In one embodiment, a cost-effective integration of medical devices 120 or
other devices
and functionality with the hospital information systems in the first and
second central computers
109, 108a is provided by isolating a subset of the total data mentioned above,
such as patient
safety-specific information, and locating such information and functionality
in a
validated/verified part of the system. In this context, an FDA regulatory
context, verified means
providing objective evidence that all requirements are tested and validated
means providing
objective evidence that the product meets customer needs. In the present
embodiment, the
validated part of the system is located within the first central computer 109.
In one

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12
embodiment, the subset can include infusion pump generated alarms and/or
alerts and/or
medical device 120 / infusion pump 120 / controller 120 programming or
operating parameter
information. This subset is isolated and located in the validated part of the
system, within the
first central computer 109, and the remaining portion of the overall data is
maintained in the
database in the non-validated portion of the system, within the second central
computer 108a.
The validated database located at the first central computer 109 and non-
validated database
located at the second central computer 108a are kept in sync using Web
services replication, as
will be better understood by one of ordinary skill in the art from the details
provided below. An
alternate embodiment may include both the validated and unvalidated portions
of the system
residing on a single computer and functionally separated by means of a
software firewall (e.g.,
operating system features or other OTS software). As will be described below,
the "syncing"
may be performed periodically based on time intervals, other predetermined
times, and/or as
needed when important data, such as patient registration status, changes
occur. At intervals, a
fresh new copy of the replicated data is sent to the other central computer,
and validated first
central computer 109 replaces its local copy with the new copy. When critical
information
changes, the change is propagated immediately to the validated first central
computer 109 and
processed as a change rather than as a replacement of the existing
information. Thus, a portion
or all of the subset located at the database at the first central computer 109
also exists at the
second central computer 108a, as will be understood from the details provided
herein. This
process will be better understood with reference to the details provided
below. Thus, by
localizing a subset of the database, such as the patient safety-specific data
at the first central
computer, at least the cost of system development is further optimized, and
integration with
third-party non-validated systems and the respective data and information
therein is made more
time and cost effective.
In one embodiment, the first central computer 109 can comprise a validated
server, such
as a Compaq DLG-380 with Windows 2003 Server OS, running Active Directory for
user and
device authentication, Certificate Authority for issuance of server and client
certificates, SQL
Server 2000 for temporary data storage, Internet Information Server (ITS) for
application
hosting (Web Services and Web pages). The second central computer 108a can
comprise a
non-validated Server, such as an external Hospital Information System (HIS)
Server connected
through a dedicated Ethernet TCP/IP connection 103 accessing a data
replication Web service
exposed by the validated server at the other end of the dedicated connection.
The second
central computer 108a can alternatively comprise software for performing one
or more of the
various functionalities described in general herein, such as a pharmacy and
other systems.

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Thus, the second central computer and can comprise these types of functions
and have an
interface with other systems, such as an external Hospital Information Systeni
(HIS) Server.
The first central computer (i.e., server 109) includes a database containing a
data storage
package or first database. In an embodiment, the first database can be
external or internal to the
first central computer 109, but preferably is only accessible to users of the
application 5412, as
shown in FIGURE 54, loaded on the first central computer. The data tables
within the first
database are used within the use cases described further herein. Preferably,
the data tables
include tables related to medical devices, digital assistants, hubs, patients,
clinician,
prescriptions, titration, comparison information, alarms, and escalations.
Moreover, medical
device tables can include tables related to pump, pump channel, pump sub-
channel. Also,
alarm tables can include tables related to hub alarms, pump alarms, channel
alarms, an alarm
history log, and the like.
In an embodiment, each table can include a key wherein data within the table
is
responsive to the key. For example, a key to a table regarding a pump channel
information log
can be a pump channel log identification wherein, in response to the key,
table data is provided
regarding the channel identification, pump rate, dose mode, dose, volume
remaining, primary
volume infused, and the like. Moreover, the tables can be linked. For
instance, a patient table
having patient infoimation can be linked to a clinician table which can be
linked to a digital
assistant table.
The patient care system 100 of FIGURE 3 can be divided into a hub subsystem, a
first
central computer or server subsystem, a medical device or pump subsystem, a
second central
computer or server subsystem, and a personal digital assistant (PDA)
subsystem. The hub
subsystem and the first central computer subsystem are discussed in detail
further herein.
Turning to the medical device subsystem, this subsystem preferably includes
one or more
medical devices 120 such as infusion devices for allowing delivery of
medication to a patient
wherein status and infusion information for each infusion device is
transmitted periodically
from a communication port associated with each device.
Generally, the second central computer subsystem is a server 108a having
computer
hardware and software for interfacing with a pharmacy system to provide
information regarding
drugs, patients, and typical nurse workflows. The server 108a can also have
various other
applications as previously discussed herein, such as an interface to a
Hospital Infatuation
System (HIS). Preferably, the second central computer interfaces with the
first central
computer subsystem to provide the first central computer with information
regarding patients,
nurses, orders, and the association between a personal digital assistant and a
nurse or clinician.

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In one embodiment, a central computer has at least two environments: a
validated
environment and a non-validated environment. The validated environment may
have a first
operating system with a set of applications and a first database. The first
database may have a
first functional feature set associated with certain data therein. In one
embodiment, this
functional feature set has functions related to the medical device and the
user interface for the
medical device. The medical device and user interface communicate directly and
securely with
the validated environment. The non-validated environment may have a second
operating
system with a set of applications arid a second database. The second database
may have a
second functional feature set associated with certain data therein. Typically,
there is a logical
separation between the validated environment and the non-validated
environment. The user
interface can receive data from the non-validation portion of the database
relating to the second
functional feature through validation portion of the system. In one
embodiment, the validation
portion is separated from the non-validation portion by a logical separation
or fire wall, which
may be implemented in software. Various software, such as VMware and Virtual
PC, are
examples of emulation software that emulates multiple environments on the same
server. In
another embodiment, the validation portion may be on the first central
computer 109, and the
non-validation portion may be on the second central computer 108a. In another
embodiment,
the central computer comprises a first server and a second separate server.
The first and second
servers are separated by a fire wall, and the central validation portion of
the central computer
resides in the first server, and the second non-validation portion of the
central computer resides
on the second server.
Preferably, as explained in detail elsewhere herein, the personal digital
assistant
subsystem includes one or more small portable devices 118 that provide
clinicians and nurses
116 (FIGURE 1) with remote information regarding: their patients; the status
of infusions
including the relay of alarms and alerts information; and infusion comparison
results. As
discussed herein, the first central computer is operably connected to one or
more personal
digital assistants 118 within the PDA subsystem. In an embodiment, the
personal digital
assistants are WINDOWS CE.NET based and used as a clinician terminal device.
In particular,
the personal digital assistant can be operably connected to the first central
computer through a
secure PKI-authenticated wireless LAN (802.1x) connection, as explained in
more detail
herein.
The hub subsystem preferably includes components such as one or more hubs 107
for
receiving data from the medical devices 120, transmitting the pump data to the
first central
computer subsystem 109, and detecting conditions that can effect data
communications with

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one or more hubs.
As indicated previously, in an embodiment, a hub 107 within the hub subsystem
interfaces with up to four infusion devices 120 through a one-way serial
communications link
105 wherein the infusion devices transmit messages (i.e., packets of data)
containing pump
5 status information on a periodic basis to the hub. Alternatively, the
packets can be transmitted
based on user defined criteria such as regular time intervals, event
occurrences, a combination
of time intervals and event occurrences, or the like.
Each hub 107 within the hub subsystem filters incoming information to reject
duplicate
messages, stores, and then forwards the pump information to the first central
computer
10 subsystem utilizing, in an embodiment, a built-in wireless network
transceiver. In an
embodiment, the pump information is not forwarded unless the data received
from the medical
device has changed.
The transceiver built into a hub 107 routes the outgoing information to a
wireless access
point 114 which in turn routes it to the first central computer 109 using the
wired Ethernet
15 subsystem 110. This outgoing information preferably contains XML encoded
data formatted as
SOAP messages specifically designed to be received by a web services type of
software
interface.
As will be appreciated by those having ordinary skill in the art, the term
"XML" refers
to a system for organizing and tagging elements of web documents wherein, with
XML,
customized tags can be created for enabling the definition, transmission,
validation, and
interpretation of data between applications and between systems or subsystems.
Moreover, as
used herein, the with. "web services" refers to integrating web-based services
using XML and
SOAP wherein the term "SOAP" is a messaging protocol used to encode the
information in
web service request messages and response messages before sending them over
the network or
communication path.
The first central computer subsystem preferably consists of a server 109 with
a software
application loaded and configured for sending and receiving data to and from
multiple hubs
107, multiple digital assistants 118, and the second central computer sub-
system comprising
sever 108a.
Turning to FIGURE 54, server 109 is preferably a COMPAQ DLG-380 with a
MICROSOFT WINDOWS 2003 Server operating system 5414. In one embodiment,
software
components that are loaded within the memory of the first central computer 109
include a first
central computer or server application 5412 within a .NET Framework 5416, an
Active
Directory Domain Service 5418 for users and device authentication, an SQL
Server 5420 (show

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16
as a database) for temporary data storage, and Internet Information Server 542
(IIS) for
application hosting. The .NET Framework 5416 is preferably Microsoft .NET
Framework 1.1
or greater wherein the .NET Framework connects the first central computer
application 5412 to
the operating system, Internet Information Server 5422, SQL Database 5420, and
Active
Directory Domain Service 5418 components. As will be appreciated by those
having ordinary
skill in the art, the Active Directory Domain Service 5418 provides services
utilized by the
Windows Server Operating System 5414 and the first central computer
application 5412 to
assist in ensuring that only authentic and authorized hub subsystem, second
central computer
subsystem and users of the personal digital assistant subsystem have access to
the first central
computer and thus the first central computer application 5412.
In an embodiment, the first central computer (i.e., server 109 of FIGURE 3)
performs
several functions that include: 1) comparison of the prescription parameters
as received from
the second central computer subsystem to the applicable programmed pump
setting received
from the hub subsystem ancUor program the pump; 2) relay of alarm and alert
information
received from the hub subsystem to the appropriate personal digital assistant
118 (FIGURE 3);
3) provision of pump status and flow rate history information to the
appropriate personal digital
assistant 118; 4) relay of pharmacy and patient information as communicated
from the second
central computer 108a (FIGURE 3) to the appropriate personal digital assistant
118; and, 5)
compilation of pump and alarm monitoring data and relaying of this data to the
second central
computer 108a on a periodic basis.
The first central computer preferably includes a plurality of external
software
component interfaces. In an embodiment, three of these interfaces can be
classified as
"incoming interfaces" that receive incoming HTTP request messages and then
issue outgoing
HTTP response messages. The remaining two interfaces can be classified as
"outgoing
interfaces" that either send H'TTP request messages or XML formatted response
messages as
explained below. As used herein, the five software interfaces are referred to
as the
DatabaseRefreshListener incoming and outgoing interfaces, the RoutePDA
incoming and
outgoing interfaces, and the PumpDataListener incoming interface.
In an embodiment, four of the external software component interfaces are
paired to
create two distinct bi-directional communication channels between the first
central computer
109 and the second central computer 108a of FIGURE 3. The first channel
includes both the
DatabaseRefreshListener incoming and outgoing interfaces paired together.
Accordingly, the
first channel is referred to herein as "DatabaseRefreshListener," and is
utilized by the second
central computer 108a for periodic synchronization of data in its database
tables with data

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17
located in the first central computer's database tables.
Using the DatabaseRefreshListener channel, the second central computer 108a
updates
the first central computer's database tables by sending XML encoded data
formatted as SOAP
messages to the first central computer's web services type of interface.
Similarly, the second
central computer 108a updates its own database table by sending XML encoded
requests for
data to the first central computer's web services type of interface which in
turn triggers the first
central computer 109 to respond with XML encoded data.
As indicated above, the incoming interface portion of the
DatabaseRefreshListener
channel is utilized by the second central computer for updating of database
tables located in the
first central computer with data from second central computer's database
tables. Moreover, the
outgoing portion of the DatabaseRefreshListener channel is utilized by the
second central
computer for updating its own database with data from the first central
computer's database
tables.
Preferably, the DatabaseRefreshListener incoming interface contains several
web
service methods named "RefreshXXX" where "XXX" corresponds to the type of data
being
transferred. In an embodiment, these methods receive incoming HTTP request
messages
containing XML encoded data formatted per the SOAP protocol. The XML encoded
data is
structure in a form that corresponds to rows in a database table. For example,
the method
"RefreshUsers" receives data structures consisting of pairs of user names and
user passwords
corresponding to rows in a database table that contains user name and user
password columns.
As shown in FIGURE 54, the incoming messages are routed via the Internet
Information Sever and the .NET Framework components to the application 5412
loaded on the
first central computer (i.e., server 109 of FIGURE 3). The first central
computer application
5412 utilizes the Active Directory Domain Service 5418 to verify that the
second central
computer message is authentic, processes the contents, and then stores the
resulting data in the
SQL server database component 5420.
The application 5412 loaded on the first central computer then responds to the
second
central computer by issuing an HTTP response method that is routed via the
.NET Framework
component 5416 and intemet infoimation sever component 5422 to the second
central
computer. This response message indicates the success or failure of the data
transfer and
processing.
Preferably, the DatabaseRefreshListener incoming interface is asynchronous in
nature,
thus decoupling the second central computer from the first central computer to
the extent
practical. This decoupling allows the second central computer to be programmed
for continued

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18
data processing while waiting for responses and for responding to losses in
communication in a
manner that is under program control. Moreover, the DatabaseRefreshListener
incoming
interface can also contain a web method for use by the second central computer
to periodically
signal the first central computer that the second central computer is
functioning.
In contrast to the DatabaseRefreshListener incoming interface, the
DatabaseRefreshListener outgoing interface is utilized by the second central
computer for
updating its own database with data from the first central computer's database
tables. To
ensure that the data has been captured by the second central computer before
permanent
removal from the first central computer, DatabaseRefreshListener outgoing
interface utilizes a
multi-step approach for data transfer as follows: 1) The second central
computer checks for the
availability of the data; 2) The second central computer requests that the
first central computer
send the data; 3) the second central computer confimis that the data has been
received; 4) the
second central computer confirms that the data has been correctly stored in
its database tables.
To check for the availability of data, the second central computer first sends
to the
applicable web method of the DatabaseRefreshListener outgoing interface is an
XML encoded
request message formatted per the SOAP protocol. Preferably, the specific web
method utilized
is of the form "BeginGetXXXTo Archive" wherein "XXX" corresponds to the type
of data
being requested. For example, the method "BeginGetChannelDataToArchive"
request the
availability of time stamped pump channel records received by the first
central computer from
the pumps through the hub subsystem.
The request message is passed through the Internet Information Server
component 5422
and .NET Framework component 5416 to the application loaded within the first
central
computer. The application 5412 loaded within the first central computer
decodes the XML
contained in the request message to determine what data is being requested by
the second
central computer.
The application 5412 loaded within the first central computer checks for the
availability
of the requested data in the SQL Server Database 5420. If the data is
available, the application
prepares an XML encoded response message indicating that data is available. If
the data cannot
be obtained, the application 5412 prepares an XIVa. encoded response message
indicating that
data is not available.
If the data is not available, the second central computer may retry or proceed
with a
different transfer consistent with its processing rules.
If the data is available, the second central computer initiates the data
transfer by sending
to the applicable web method of DatabaseRefreshListener outgoing interface a
second XML

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19
encoded request message. Preferably, the specific web method utilized is of
the form
"EndGetXXXToAcrchive" wherein "XXX" is identical to that used above.
The application 5412 within the first central computer decodes the XML
contained in
the request message to determine what data to return to the second central
computer and places
the data in an appropriate XML encoded response message structured in a fowl
that
corresponds to rows in a database table consistent with the approach utilized
by the
corresponding incoming interface.
In an embodiment, the data is routed to the second central computer via the
.NET
Framework component 5416 and Internet Information Server component 5422. If
the data was
not correctly received, the second central computer may retry or proceed with
a different
transfer consistent with its processing rules.
If the data was received correctly, the second central computer then sends a
third request
message to the applicable web method of this interface. Preferably, the
specific web method
utilized is of the form "BeginDeleteArchivedXXX" where "XXX" is identical to
that used
above.
Upon receipt of this message, the application 5412 loaded within the first
central
computer marks the relevant data in the SQL Server Database component as being
sent to the
second central computer for archiving and issues a response message
acknowledging that the
data has been marked.
To signal the success or failure of storing the data in the second central
computer
database, the second central computer sends a fourth request message to the
applicable web
method of this interface. The
specific web method utilized is of the form
"End.DeleteArchivedXXX" where "XXX" is identical to that used above.
If the second central computer indicates that the transfer was unsuccessful or
if
sufficient time has elapsed that the first central computer determines that a
loss of
communication has occurred, then the relevant data is retained in the first
central computer
database for further transfer as requested by the second central computer.
If the second central computer indicates that the transfer was successful,
then the
archived data is purged from the first central computer database and the
application 5412
loaded within the first central computer issues a response message confirming
completion of
the final step of this transfer.
Preferably, the DatabaseRefreshListener outgoing interface is asynchronous in
nature,
thus decoupling the second central computer database from the first central
computer to the
extent practical.

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The second bi-directional channel between the first central computer 109 and
the second
central computer 108a is referred to herein as "RoutePDA" and includes both
the RoutePDA
incoming and outgoing interfaces paired together. The RoutePDA channel is used
by the first
central computer 109 for routing of HTTP request messages originating from the
PDA
5 subsystem to the second central computer 108a, then receiving the
corresponding HTIP
response messages from the second central computer, processing if applicable,
and then routing
back to the originating personal digital assistant 118.
In the second channel (i.e., RoutePDA), messages received from or sent to a
personal
digital assistant 118 are preferably transmitted to and from the first central
computer 109 via the
10 hospital or healthcare facility's wired Ethernet system 110, a wireless
access point 114, an a
wireless transceiver built-into each personal digital assistant 118.
Preferably, HTTP request messages are forwarded without processing through the
first
central computer 109 to the second central computer 108a. The second central
computer 108a
then issues HTTP response messages containing either XML or HTML formatted
information.
15 HTML formatted response messages are routed through the first central
computer 109 to the
personal digital assistant 118 without further handling.
XML formatted response messages are used by the second central computer 108a
to
signal to the first central computer 109 that the user 116 (FIGURE 1) has
requested a web page
that the first central computer 109 creates, such as a prescription comparison
results page or a
20 pump-monitoring page. The first central computer 109 examines the XML
response, processes
as appropriate, and issues an HTML or XML formatted response message to the
sending
personal digital assistant 118.
As indicated previously, the RoutePDA channel is used by the first central
computer for
routing of HTTP request message received from the PDA(s) 118 to the second
central computer
and then receiving the corresponding HTTP responses returned by the second
central computer,
processing if applicable, and then routing back to the sending PDA(s).
Accordingly, the RoutePDA incoming interface is utilized for communication
with the
web browser located in the PDA(s) 118. This interface receives incoming H __
l'IP request
messages containing data encoded as name-value pairs consistent with the HTTP
"GET" and
"POST" protocols. The incoming messages are routed via the Internet
Information Sever and
the .NET Framework component to the application 5412 loaded within the first
central
computer. The application 5412 loaded on the first central computer reroutes
the incoming
message to the second central computer utilizing the .NET Framework 5416 and
the RoutePDA
outgoing interface as discussed below.

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When an HTTP response is received at the RoutePDA outgoing interface, the
application 5412 loaded on the first central computer determines whether the
response utilizes
HTHL or XML formatting. HTML formatted responses are rerouted by the first
central
computer to the PDA without further handling, via the .NET Framework component
5416 and
Internet Information Server component 5422.
XML formatted responses, however, are used by the second central computer to
signal
to the first central computer that the user has requested a web page that the
first central
computer creates, such as a prescription comparison results page or a pump-
monitoring page.
The first central computer examines the XML response from the second central
computer,
processes as appropriate, and issues an HTML or XML formatted response to the
appropriate
PDA(s), via the .NET Framework and Internet Infounation Server components.
Preferably, the
RoutePDA interface is synchronous in nature due to the inherent synchronous
behavior of the
web browsers contained in the PDAs.
In contrast to the RoutePDA incoming interface, the RoutePDA outgoing
interface is
utilized for routing HTTP request messages received by the application 5412
loaded on the first
central computer from the personal digital assistant subsystem to the second
central computer
for processing and then receiving the corresponding H ____________________ U P
response sent by the second central
computer in return.
In both the DatabaseRefreshListener channel and the RoutePDA channel, the
first
central computer 109 sends and receives information from the second central
computer 108a
through an isolated point-to-point Ethernet sub-system 103 that is preferably
dedicated to this
use only.
As indicated above, in utilizing the DatabaseRefreshListener channel, the
first central
computer exposes a specialized Web service on the dedicated link 103 that is
used by the
second central computer to replicate new and updated database information
(such as patient
information, clinician information, phalinacy information, and the like)
periodically and as
needed to the first central computer. Also, data is provided from the second
central computer to
the first central computer.
Moreover, in utilizing the RoutePDA channel at the clinician terminal device
end, the
first central computer 109 exposes a NET IIS Server interface serving HTTP-
style web pages
and maintaining authenticated web session with the PDA devices 118. Stated
another way, the
clinician tei ____________________________________________________________
minal device (i.e., personal digital assistant 118) receives authenticated web
pages
from the first central computer 109.
At the first central computer end of the dedicated connection 103 to the
second central

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computer, the first central computer establishes a virtual HTTP session for
each PDA device
118 connected to the first central computer, and impersonates a Web browser to
the second
central computer relaying HTTP request from the PDAs as they are being
received by the first
central computer. Stated another way, the first central computer, through the
dedicated
connection 103 to the second central computer, relays requests requiring non-
validation to the
second central computer.
Accordingly, when the information flow between a PDA 118 and the server system

requires information originating from the second central computer side or
merged information
be presented, the second central computer posts an XML SOAP packet to the Web
service
exposed by the first central computer on the dedicated link 103 and the first
central computer
uses the XML data to perform a merger operation with the infoullation
originating from the
first central computer side of the system, converts the result to HTML, and
then posts the
HTML back to the clinician's PDA device 118.
The fifth external software component interface, referred to as
PumpDataListener is an
incoming interface for communication with the hub subsystem, as explained in
more detail
herein. In an embodiment, the PumpDataListener interface does not have a
corresponding
outgoing interface because the transfer of pump data is one-way, only, except
for
communication verification. However, in an alternative embodiment, an outgoing
interface can
be provided for transfer of pump command and control data to the medical
devices 120.
The PumpDataListener incoming interface is utilized for receipt of data from
the hub
subsystem. Preferably, this interface contains a single web service method
referred to as
"SendPumpData." This method receives incoming HTTP request messages containing
XML
encoded data formatted per the SOAP protocol. The XML encoded data is
structured in a
hierarchical form such that data from several pumps and several channels per
pump at several
different times can be combined into a single large message structure.
The incoming messages are routed via the Internet Infainiation Sever and the
.NET
Framework components to the application 5412 loaded within the first central
computer
application. The first central computer application utilizes the Active
Directory Domain
Service component to verify that the hub subsystem message is authentic. The
first central
computer then processes the contents, and stores the resulting data in the SQL
Server Database
component. Finally, the first central computer application issues an HITP
response message to
the sending hub device via the .NET Framework and Internet Information Sever
components.
This response messages indicated the success or failure of data transfer and
processing.
Data packets received by the first central computer (i.e., server 109) from
the hubs 107

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are preferably stored within the first central database of the first central
computer. Preferably,
if an alarm or alert event is included in the packet, the first central
computer can immediately
dispatch the event to the appropriate clinician(s) via his or her digital
assistant 118, or
alternatively, the first central computer can enter the event into the first
central computer
database and later dispatch the information when requested by the appropriate
clinician(s) via
his or her digital assistant. As indicated previously, the first central
computer 109 maintains a
log of all clinicians that are logged onto his or her digital assistant 118
which is authenticated
every time the clinician logs onto the system.
Preferably, the PumpDataListener incoming interface is asynchronous in nature,
thus
decoupling the hub subsystem from the first central computer subsystem to the
extent practical.
The decoupling allows the hubs 107 within the hub subsystem to be programmed
for continued
data processing while waiting for responses and for responding to losses in
communication in a
manner that is under program control. Nonetheless, the PumpDataListener
maintains a
"heartbeat" to monitor (lack of) continuity of communications between all
wireless modules
and/or remote pump devices and the central computer.
Communication With Clinician Handheld Devices
As described in detail further herein, pump status, alerts, alarms, patient
information,
chart information, comparison information, to-do lists and other
data/information are provided
to clinicians via a personal digital assistant or user interface 118 having a
display 118a and, if
desired, an audible tone or sound generator (not shown). The digital assistant
118
communicates with the central system 108 via the central network 102 and, in
particular,
wireless communication path or link 126 and cable communication system 110. As
stated
previously, one or more wireless access points 114 provide an interface, in a
conventional
manner, between the wireless communication paths and the cable communication
system. The
digital assistant 118 may receive messages from both servers 109 and 108a.
Preferably, communication between the central system 108 and the digital
assistant 118
is bidirectional. Moreover, it is desired that the digital assistant 118
include enough memory
and processing capability to store and execute a module or application (not
shown) for testing
the integrity of the communication link between the digital assistant and the
central system 108
or the wireless access point 114.
Preferably, but not necessarily, a module or application installed on the
digital assistant
118 is a script or other computer instructions (i.e., software code) written
in a high-level
programming language, such as JAVA, that can be executed with or without
clinician
intervention. The script can be automatically downloaded from the server 108a
or 109 to the

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24
digital assistant 118, or to the medical device 120, as a receiver function of
the system. As an
example, one type of script that may be automatically downloaded from the
server to the digital
assistant is a script that tests the integrity of the communication link by
periodically polling, or
monitoring communication, including notifications and messaging, from the
central system 108
or the access point 114. In a preferred embodiment, the script running on the
digital assistant
polls the system 108 approximately every 3 seconds. If a response is not
received from the
central system 108 or the access point 114, the module or application
installed on the digital
assistant 118 generates a time-out that results in audible tones and/or a
notification on the visual
display 118a that communication with the central system 108 has been lost. The
notification on
the visual display 118a can be, for example: the activation of an information
pop-up window
stating that the communication link is lost, or the changing of an active icon
display on the
visual display 118a. As used herein, and recognized by those having ordinary
skill in the art, a
time-out is an output generated by a module or application for indicating that
the module or
application has waited a certain amount of time for input, but has not
received it. Another type
of script may poll to determine if an alarm or alert has been triggered.
Numerous other scripts
may be running simultaneously. One advantage of running scripts that are
downloaded from
the system to the digital assistant is that there is no need to install custom
code on each digital
assistant 118. If any event (i.e., a message, notification, alarm, alert,
etc.) is present, the digital
assistant 118 automatically retrieves the event from the server and displays
it on an interface
screen of the digital assistant 118. Other added advantages of the script
approach are 1) the
script code can be easily updated at the central server instead of requiring
each digital assistant
to be updated, 2) the scripts can be verified/validated relatively
independently of the digital
assistant hardware platform because the functionality is hardware independent,
thus changes or
upgrades to the digital assistants have minimal effect on script operation.
As indicated previously, each clinician preferably has an associated digital
assistant 118
that, in an embodiment, provides the clinician with a view of a page
consisting of an HTML
frame set with a dedicated frame for display of events. The dedicated frame
can have a JAVA
script inserted therein for display of events wherein the script interrogates
the first central
computer 119 for new events such as pump alarms and alerts directed to the
digital assistant
118. If any new events have occurred, then the first central computer provides
this information
to the digital assistant 118 wherein it is displayed within the dedicated
frame for display of such
events.
One type of notification provided on the digital assistant 118 indicates to
the clinician
that data presented by the digital assistant 118 is not current, and access to
alerts and alarms is

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not available. Conversely, the digital assistant 118 can also indicate when
the digital assistant
118 is linked to the central system 108 for providing real-time access to
alerts and alarms.
Other notifications that are typically communicated via scripts include, but
are not
limited to: pump "silent shut down," overrides of pump infusion limits, end of
infusion,
5 occlusion trend information, low battery, pre-occlusion indicator, over
use of bolus, keep vein
open alert, stat medication notifications, change orders, lab results,
radiology results, updating,
change in telemetry data and/or vital signs information, doctors or pharmacy
attempting to
reach the nurse, patients that are requesting the nurse, loss of
communication, messages from
other devices, new rate for medical device based on vital information, rate
following purge, etc.
10 As
stated previously, clinicians within a healthcare facility have access to
infusion
alerts, alarms, and messages via the remote wireless device 118 (i.e., also
referred to as a
personal digital assistant (PDA) 118) or other computer devices, wireless or
hardwired to the
network 108, such as a tablet computer with a bar code reader operably
attached, or a laptop
computer attached to an IV pole and having a bar code reader operably attached
to the
15 computer.
Preferably, the infusion system 210 provides clinicians and other users with
options for
automating alert event-driven messages. Moreover, healthcare facility
administrators and other
users can customize the types of automated messaging to appear, via the remote
wireless
device, by message type or classification, severity of abnormality, and time-
based reminders.
20 Additionally, the infusion system provides clinicians and other users
with the ability to
configure audible messages, visual messages, or both.
The messaging provided by the infusion system 210 preferably includes a user-
configurable rules engine, a scheduler, and interfaces to infusion pump
systems. Moreover, it is
desired that the results-driven messaging provide clinicians with real-time
decision support at
25 the point of care via a workstation, electronic tablet, wireless
personal digital assistant, or the
like.
Generally, the communication between the infusion pump 120 and the network 102
and,
further, from the network 102 and the clinician's digital device 118 allows
the clinician 116 to:
view electronically-compared pharmacy-entered orders to programmed pump
settings and/or
program the pump, use the system as a method of remotely viewing pump alerts
and alarms,
view the pump status remotely, view notifications and view the history of the
infusion setting
changes, among other things.
Patient Care System
Turning back to FIGURE 1, patient care system 100 preferably includes a
computerized

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physician order-entry module (CPOE), an inpatient pharmacy module, a wireless
nurse charting
system, and an electronic patient medical record module. In one embodiment,
such systems and
modules are applications of the second central server or second central
computer 108a. It is
desired that patient care system 100 provide a comprehensive patient safety
solution for the
delivery of medication. Within patient care system 100, software modules are
provided to link
together existing patient care systems using interfaces such as HL7 interfaces
that are known to
those having ordinary skill in the art. Preferably, the patient care system
100 operates on a
variety of computers and personal digital-assistant products to transmit
orders, update patient
medical records, and access alerts, alamis, and messages.
The computerized physician order-entry module enables physicians to enter
medication
orders, access alerts, alarms, messages, reminders, vital signs and results. A
pharmacy module
checks the prescribed drug against documented patient allergies, and for
compatibility with
other drugs and food. The pharmacy module also provides real-time data for
inventory
management. A nurse medication-charting module provides clinical information
that is
immediately available at the bedside, thus ensuring verification of medication
and dosage at the
point-of-care.
Patient care system 100 integrates drug delivery products with the information
required
to assist in ensuring safe and effective delivery of medication. The clinical
decision support and
accompanying alerts, alarms, warnings, and messaging of the patient care
system 100 provide a
safety net of support for clinicians as they deliver patient care under
increasing time and cost
pressures. This information is preferably supplied through a wireless network
that supplies data
in a way that improves clinician workflow, making delivery of care easier.
Overview of the Infusion System
The infusion system 210, or healthcare system 210, within the patent care
system 100
provides computerized prescribing and an electronic medical administration
record (eMAR),
among other things. Infusion system 210 puts charting, medication history,
inventory tracking,
and messaging at the clinician's fingertips. Patient care system 100 combines
bar-coding and
real-time technology to assist in ensuring that the right patient gets the
right medication and the
right dosage, at the right time, via the right route. Infusion system 210
provides alerts, alarms,
messages, and reminders such as, but not limited to, lab value, out of range,
and missed dose.
As part of the verification of the right dosage, the system can also provide
verification of the
settings of an infusion pump.
As explained in detail further herein, the infusion system 210 resides, at
least in part, on
one or more electronic computing devices such as wireless remote personal
digital assistants,

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27
workstations, physician order-entry modules, electronic tablets, processor
controlled infusion
pumps, or the like. The infusion system 210 can be configured to display, via
one or more of
the electronic computing devices, numerous hospital-definable alerts and
alarms in varying
forms. In an embodiment, time-based alerts are provided to remind clinicians
to perform a
patient care function such as, but not necessarily limited to, changing an
infusion rate. Further,
emergency alarms are provided such as, but not necessarily limited to, an
infusion being
disconnected. Moreover, less urgent messages are provided such as, but not
necessarily limited
to, the infusion being completed or the line being occluded. In addition, the
infusion status can
be viewed from anywhere within the healthcare facility via one or more of
wireless remote
personal digital assistants or other electronic computing devices.
As disclosed in greater detail infra, the system 210 provides for the
escalation of alarms
or alerts that are not indicated as corrected within a predetermined period of
time. Conditions
that can result in the escalation of an alarm or an alert are preferably
defined by the health care
facility. Likewise, the time before an alarm or alert escalates can also be
defined by the health
care facility. Accordingly, predefined alarms or alerts that are not corrected
by a clinician
within a predefined period of time will result in the escalation of the
associated alarms or alerts.
Thus, the frequency that the clinician is notified by the system of the
escalated alarms or alerts
is preferably increased, as can be the volume of the audible tones associated
therewith.
As will be appreciated by those having skill in the art, the infusion system
210 assists in
ensuring patient safety by checking the infusion being administered with the
patient's order. As
explained in detail further herein, a bar-coding scheme is used wherein the
infusion bag and the
patient ID are scanned. The infusion information is displayed on both an
electronic computing
device and the pump to assist in ensuring that the right infusion is being
administered to the
right patient at the right time, and by the right route and at the right rate.
In an embodiment, an
alert, audible and visual, appears on the electronic device if the above
administration "rights" do
not match. Moreover, through a comparison process described in greater detail
infra, when the
clinician sets the infusion pump rate, an audible and visual alert appears on
the electronic
computing device if the programmed settings do not match the patient's
infusion order. In
addition, at any time the clinician can, via the electronic device, check the
settings of an
infusion pump to confirm if the settings match the infusion order as contained
within the central
database 108b.
In an embodiment, the infusion system 210 provides alerts and alarms, via one
or more
of the electronic computing devices or the like, with differing tones or
phrases for fast
identification of the severity or urgency of the message. Desirably,
conventional infusion pump

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alerts and alarms can be displayed on the electronic computing devices, such
as, but not
necessarily limited to, a personal digital assistant, to keep the clinicians
informed of the status
of the infusions for all assigned patients, thereby saving time in resolving
problems and
improving workflow safety.
All alarms and alerts are preferably retrievable from a central system
database for, inter
alia, reporting purposes. The retrievable data can assist a healthcare
facility in examining and
analyzing how many medication errors were avoided through alatins, alerts, and
warnings.
Desirably, the audible alerts and alarms are configured to sound differently
according to
the severity or urgency associated with the message or issue. Alarms requiring
immediate
attention sound different from less emergent alerts. Visual text describing
the problem is
preferably displayed by one or more of the electronic computing devices. In an
embodiment, an
alert sounds on a personal digital assistant when an infusion is nearing
completion or is
completed. The personal digital assistant also displays the patient, location,
infusion type, and
the time remaining before the infusion bag is empty. At all times the
clinician can access, via
the personal digital assistant, the status of infusions and thus react
accordingly. In an
embodiment, before visiting a patient room, the clinician can view the status
of the infusions on
the personal digital assistant to determine whether another bag will be needed
in the near future.
If another infusion bag is needed, the clinician can save time be taking the
new bag on the first
visit, rather than realizing a new bag is needed after arriving in the patient
room. Similarly, the
phatinacy can view the status, including time remaining, in order to schedule
the mixing and
delivery of the next infusion bag.
If desired, and as will be appreciated by those having skill in the art, other
alarms and
alerts related to the infusion pump can be made available on the electronic
computing devices
remotely located from the infusion pump. Pertinent information can be
displayed on the
electronic computing devices, thus saving the nurse time and steps in
resolving the problem. As
indicated above, when a pump alarms or alerts, the clinician can view patient
infoimation, drug
order, and alarm or alert message on the personal digital assistant, and
gather necessary items
before going to the patient room to physically correct the alarm or alert
condition.
In an embodiment, the infusion system 210 provides configurable time-based
alerts for
reminding clinicians of scheduled infusion orders. As such, a tapering order
to run NS at
200m1/hr for two hours, then reduce to 50m1/hr, results in the infusion system
210 alerting the
nurse two hours after starting the infusion to reduce the rate. Further, late
alerts are provided
for informing clinicians when scheduled infusions are past the time tolerance
set by the facility.
Moreover, time-based protocols such as alerts for conducting pain assessments,
such as after

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29
starting an epidural morphine infusion, are generated.
Configurable aspects of the infusion system 210 also include the audible
alerts emitted
by the electronic computing devices, such as personal digital assistants.
Preferably, the audible
alerts can be configurable by the healthcare facility and within specific
units of the healthcare
facility to satisfy the unique environments within the healthcare facility.
As indicated previously, a plurality of visual alerts and messages can be
displayed by
the electronic computing devices, such as personal digital assistants, for
indicating the
importance or urgency of the message. Desirably, color, flashing, and bold
text are display-
messaging options. Additionally, hyperlinks can be provided when messages are
generated.
Icons on the displays can also be utilized and emergency messages can be
configured to
interrupt the handheld electronic device, or the like, to immediately alert
the clinician. Further,
escalation of alarms/alerts is provided by the system 210. Alarms/alerts and
the escalation
thereof are detailed infra.
As also indicated previously, the infusion system 210 allows a clinician to
view all
infusions or assigned patients on the electronic computing device, such as a
personal digital
assistant or the like, thus reducing time spent traveling to and from patient
rooms. Moreover,
prescription information is displayed on the electronic computing device for
verification of the
drug amount, diluents, dose, and rate of the infusion. Additionally, real time
status of the
infusion is viewable for displaying milliliters per hour or the like, duration
of the infusion,
volume infused, time remaining, and volume yet to be infused. As indicated
previously, the
status of the infusion and flow rate history can be viewed from anywhere
within the healthcare
facility via the electronic computing devices.
As described in detail further herein, the infusion system 210 may calculate
ordered
doses based on patient weight and display the appropriate rate to run the
infusion. Messages are
generated if the infusion is set to run outside of the ordered dose. Moreover,
pediatric dosing is
available and configured for pediatric units within the healthcare facility.
In an embodiment, the status of primary infusions and secondary infusions,
such as
piggybacks, are displayed by the infusion system 210 on the electronic
computing device, such
as a personal digital assistant. The clinician can check the volume left to
infuse in a piggyback
at any time and a message is displayed when the piggyback is completed and the
primary
infusion has resumed. In addition, messages are sent to the pharmacy to
replenish stocks and
infusion orders.
If desired, the infusion system 210 allows for the healthcare facility to
define system
infusion limits for warning a clinician who programs an infusion to run
outside of the set range.

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The warning can be configured to allow clinicians to override the warning or
prohibit overrides.
As will be appreciated by those having ordinary skill in the art, prohibiting
overrides for certain
infusions may prevent a patient from inadvertently receiving an overdose.
The infusion system 210 can also provide for displaying reference information
pertinent
5 to the needs of each specialty unit within the healthcare facility. Drug
information is viewable
on the electronic device, such as a personal digital assistant, in addition to
specialty unit policies
and procedures. Protocols and standard orders can be configured to provide
messages based on
patient condition. In an embodiment, for example, heparin infusion protocols
are configured to
alert the clinician of a new blood glucose result and to titrate the insulin
infusion by a
10 determined number of milliliters based on the sliding scale protocol.
Moreover, through configured rules, messages or notifications are sent to the
nurse
regarding particular infusions as they relate to the patient's condition. In
an embodiment, for
example, a message is generated when a patient receiving a nephrotoxic
infusion has an
increase in BUN and Creatinine. Additionally, protocols can be configured to
generate
15 messages when certain infusions are titrated. In an embodiment, for
example, a message to
document a blood pressure can be configured when a clinician titrates a
dopamine infusion.
Furthermore, hemodynamic monitoring parameters can be linked to infusions to
generate
messages.
As indicated previously, new infusion orders can be configured to provide
messages
20 alerting the clinician of a new order. Messages can be configured as
audible and visual such as
textual, color alerts, flashing hyperlinks, icons, and the like. Stat orders
and discontinue orders
can be configured as a high priority message to differentiate them from non-
urgent messages.
Preferably, educational messages are generated and configured by the
healthcare
facility. In an embodiment, for example, an infusion requiring a specific
tubing set (e.g., non-
25 PVC) results in the display of a message informing the clinician. In a
further embodiment, for
example, an infusion requiring central venous access results in the display of
a warning not to
infuse in the peripheral vein.
In an embodiment, scheduling messages are generated and displayed on one or
more
electronic computing devices to remind users to complete the next task. Alerts
to change
30 infusion rates at scheduled times are sent to the electronic computing
devices, such as in the
case of a tapering infusion. Additionally, protocols with time-based alerts
can be configured
= such as, for example, blood infusion protocols.
Turning again to FIGURE 1, and as indicated above, patient care system 100
allows
medication ordering, dispensing, and administration to take place at the
patient's bedside.

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Physicians can order simple and complex prescriptions, intravenous therapy and
total parenteral
nutrition therapy (TPN) using a wireless handheld device. Infusion system 210
checks for drug
interactions and other possible errors as well as correct dosage. Infusion
system 210 then
transmits this data in real-time to the patient care facility or local
phaimacy, hospital nursing
unit, home care unit, and/or clinic.
The clinician can access a medical records database using the handheld device.
In an
embodiment, the clinician scans the bar-coded medication and the patient's bar-
coded bracelet
to confirm the presence of the right medication, dosage, and time before
administering any
drugs. The infusion system 210 updates medical and administrative records,
thereby
eliminating most, if not all, time-consuming paperwork. Thus, infusion system
210 can reduce
costs and improve efficiency while possibly saving lives. Patient care system
100 can include
access-controlled mobile and stationary medication and supply depots,
including electronic
patient medical records and computerized prescribing, providing complete
preparation and
inventory management from the point of care to the pharmacy.
As mentioned previously, FIGURE 1 is a graphical representation of patient
care system
100. The patient care system 100 includes a pharmacy computer 104, a central
system 108, and
a treatment location 106, linked by a network 102. In an embodiment, the
pharmacy computer
104 includes a processing unit 104a, a keyboard 104b, a video display 104c, a
printer 104d, a
bar code reader 104e, and a mouse 104f. Although not shown in FIGURE 1, the
patient care
system 100 can also include subsystems for hospital administration, nursing
stations, a clinical
information subsystem, a hospital information subsystem, an Admissions
Discharge and
Transfer (ADT) subsystem, a billing subsystem, and/or other subsystems
typically included in
conventional patient care systems. Such systems are typically interfaced with
the second
central server 108a.
In an embodiment, the central system 108 includes a central servicing computer
108a, a
database 108b, a video display 108c, input/output components, and other
conventional hardware
components known to those having ordinary skill in the art. The network 102
preferably
includes a cable communication system 110 portion and a wireless communication
system
portion. The cable communication system 110 can be, but is not limited to, an
Ethernet cabling
system, and a thin net system.
In an embodiment, the treatment location 106 can include a treatment bed 106a,
an
infusion pump 120, and medical treatment cart 132. In FIGURE 1, a clinician
116 and a patient
112 are shown in the treatment location 106. Medication 124 can be of a type
that is
administered using an infusion pump 120 or other medical device. Medication
124 can also be

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of a type that is administered without using a medical device. The medication
can be stored in
medication storage areas 132a of medical treatment cart 132. The clinician 116
uses a digital
assistant 118 in the process of administering medication 124 to the patient
112.
In an embodiment, the clinician 116 uses the digital assistant 118 in the
course of
treating a patient 112 to communicate with the cable communication system 110
of the network
102 via a first wireless communication path 126. The infusion pump 120 has the
ability to
communicate with the cable communication system 110 via a second wireless
communication
path 128. The medication cart 132 also has the ability to communicate via a
wireless
communication path (not shown in FIGURE 1). A wireless transceiver 114
interfaces with the
cable communication system 110. The wireless communication system portion of
the network
can employ technology such as, but not limited to, known to those having
ordinary skill in the
art such as IEEE 802.11b "Wireless Ethernet," a local area network, wireless
local area
networks, a network having a tree topography, a network having a ring
topography, wireless
internet point of presence systems, an Ethernet, the Internet, radio
communications, infrared,
fiber optic, and telephone. Though shown in FIGURE 1 as a wireless
communication system,
the communication paths can alternatively be hardwired communication paths.
In the patient care system 100, a physician can order medication 124 for
patient 112. In
an embodiment, the order can originate with a clinician 116 at the treatment
location 106. The
physician and/or clinician 116 can use a computerized physician order entry
system (CPOE),
the medical cart 132, or a like device, to order the medication 124 for the
patient 112. Those
having ordinary skill in the art are familiar with conventional computerized
physician order
entry systems. Despite its name, any clinician 116 can use the computerized
physician order
entry system. If the medication 124 is efficient to administer through
infusion pump 120, the
infusion order includes information for generating operating parameters for
the infusion pump
120. The operating parameters are the information and/or instruction set
necessary to program
infusion pump 120 to operate in accordance with the infusion order.
The infusion order can be entered in a variety of locations including the
pharmacy, the
nursing center, the nursing floor, and treatment location 106. When the order
is entered in the
pharmacy, it can be entered in the pharmacy computer 104 via input/output
devices such as the
keyboard 104b, the mouse 104f, a touch screen display, the CPOE system and/or
the medical
treatment cart 132. The processing unit 104a is able to transform a manually
entered order into
computer-readable data. Devices such as the CPOE can transform an order into
computer-
readable data prior to introduction to the processing unit 104a. The operating
parameters are
then printed in a bar code fatmat by the printer 104d on a medication label
124a. The

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medication label 124a is then affixed to a medication 124 container. Next, the
medication 124
container is transported to the treatment location 106. The medication 124 can
then be
administered to the patient 112 in a variety of ways known in the art
including orally and
through an infusion pump 120. If the medication 124 is administered orally,
the clinician 116
can communicate via the digital assistant 118 and/or the medical cart 132. The
medical cart 132
is computerized and generally has a keyboard (not shown), a display 132b, and
other
input/output devices such as a bar code scanner (not shown).
As will be appreciated by those having ordinary skill in the art, the infusion
bag can also
be premixed, wherein a non-patient specific bar code is attached to the bag
identifying the
medication 124. Moreover, the infusion bag can be mixed in the pharmacy or on
the floor,
wherein a patient specific bar code is attached to the bag that identifies the
medication 124 and,
if desired, when the medication is to be administered to the patient.
At the treatment location, the medication 124 can be mounted on the infusion
pump 120
with an intravenous (IV) line 130 running from the infusion pump 120 to the
patient 112. The
infusion pump 120 can include a pumping unit 120a, a keypad 120b, a display
120c, an infusion
pump ID 120d, and an antenna 120e. Prior art infusion pumps can be provided
with a wireless
adaptor (not shown) in order to fully implement the system 100. The wireless
adaptor can have
its own battery if necessary to avoid reducing the battery life of prior art
infusion pumps. The
wireless adaptor can also use intelligent data management such as, but not
limited to, store-and-
forward data management and data compression to minimize power consumption and
network
traffic. The wireless adaptor can also include the ability to communicate with
the digital
assistant 118 even when the network 102 is not functioning.
In an embodiment, the patient care system 100 can include a variety of
identifiers such
as, but not limited to, personnel, equipment, and medication identifiers. In
FIGURE 1, the
clinician 116 can have a clinician badge 116a identifier, the patient 112 can
have a wristband
112a identifier, the infusion pump 120 can have an infusion pump ID 120d
identifier, and the
medication 124 can have a medication label 124a identifier. Clinician badge
116a, wristband
112a, infusion pump ID 120d, and medication label 124a include information to
identify the
personnel, equipment, or medication they are associated with. The identifiers
can also have
additional information. For example, the medication label 124a can include
information
regarding the intended recipient of the medication 124, operating parameters
for infusion pump
120, and infoiniation regarding the lot number and expiration of medication
124. The
information included in the identifiers can be printed, but is preferably in a
device readable
format such as, but not limited to, an optical-readable device format such as
a bar code, a radio

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frequency (RE) device-readable format such as an RFID, an iButton, a smart
card, and a laser-
readable format. The digital assistant 118 can include a display 118a and have
the ability to
read the identifiers, including biometric information such as a fingerprint.
The wristband 112a is typically placed on the patient 112 as the patient 112
enters a
medical care facility. The wristband 112a includes a patient identifier. The
patient identifier
can include printed information to identify the patient and additional
information such as a
treating physician's name(s). The patient identifier for patient 112 can
include information such
as, but not limited to, the patient's name, age, social security number, the
patient's blood type,
address, allergies, a hospital ID number, and the name of a patient's
relative. In an
embodiment, the patient identifier can contain a unique reference code or
password for the
patient, which is also stored in the central database for cross referencing,
if needed or desired.
System Hardware/Software Architecture of the System
FIGURE 2 is a block diagram of a computer 200 representative of the pharmacy
computer 104, the central system 108, the CPOE, the digital assistant 118 of
FIGURE 1, and/or
a computer included in any number of other subsystems that communicate via the
network 102
such as the medication treatment cart 132. As indicated previously, the
computer 200 includes
an infusion system 210, or a portion of infusion system 210, for use within
the patient care
system 100. The infusion system as described in reference to FIGURE 2 is
preferably a
computer program. However, the infusion system can be practiced in whole or in
part as a
method and system other than as a computer program.
A critical concern in the art is that the right medication is administered to
the right
patient. Therefore, infusion system 210 includes features to assist in
assuring that the right
medication is administered to the right patient in an efficient manner.
Infusion system 210 can
be implemented in software, firmware, hardware, or a combination thereof. In
one mode,
infusion system 210 is implemented in software, as an executable program,. and
is executed by
one or more special or general purpose digital computer(s), such as a personal
computer (PC;
IBM-compatible, Apple-compatible, or otherwise), personal digital assistant,
workstation,
minicomputer, or mainframe computer. An example of a general-purpose computer
that can
implement the infusion system 210 is shown in FIGURE 2. The infusion system
210 can reside
in, or have various portions residing in, any computer such as, but not
limited to, pharmacy
computer 104, central system 108, medication treatment cart 132, and digital
assistant 118.
Therefore, the computer 200 of FIGURE 2 is representative of any computer in
which the
infusion system 210 resides or partially resides.
Generally, in terms of hardware architecture, as shown in FIGURE 2, the
computer 200

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includes a processor 202, memory 204, and one or more input and/or output
(I/O) devices 206
(or peripherals) that are communicatively coupled via a local interface 208.
The local interface
208 can be, for example, but not limited to, one or more buses or other wired
or wireless
connections, as is known in the art. The local interface 208 can have
additional elements, which
5 are omitted for simplicity, such as controllers, buffers (caches),
drivers, repeaters, and receivers,
to enable communications. Further, the local interface can include address,
control, and/or data
connections to enable appropriate communications among the other computer
components.
Processor 202 is a hardware device for executing software, particularly
software stored
in memory 204. Processor 202 can be any custom made or commercially available
processor, a
10 central processing unit (CPU), an auxiliary processor among several
processors associated with
the computer 200, a semiconductor-based microprocessor (in the form of a
microchip or chip
set), a macroprocessor, or generally any device for executing software
instructions. Examples
of suitable commercially available microprocessors are as follows: a PA-RISC
series
microprocessor from Hewlett-Packard Company, an 80x86 or Pentium series
microprocessor
15 from Intel Corporation, a PowerPC microprocessor from IBM, a Sparc
microprocessor from
Sun Microsystems, Inc., or a 68xxx series microprocessor from Motorola
Corporation.
Processor 202 can also represent a distributed processing architecture such
as, but not limited
to, SQL, Smalltalk, APL, KLisp, Snobol, Developer 200, MUMPS/Magic.
Memory 204 can include any one or a combination of volatile memory elements
(e.g.,
20 random access memory (RAM, such as DRAM, SRAM, SDRAM, etc.)) and
nonvolatile
memory elements (e.g., ROM, hard drive, tape, CDROM, etc.). Moreover, memory
204 can
incorporate electronic, magnetic, optical, and/or other types of storage
media. Memory 204 can
have a distributed architecture where various components are situated remote
from one another,
but are still accessed by processor 202.
25 The software in memory 204 can include one or more separate programs.
The separate
programs comprise ordered listings of executable instructions for implementing
logical
functions. In FIGURE 2, the software in memory 204 includes the infusion
system 210 in
accordance with the present embodiment and a suitable operating system (0/S)
212. A non-
exhaustive list of examples of suitable commercially available operating
systems 212 is as
30 follows: (a) a Windows operating system available from Microsoft
Corporation; (b) a Netware
operating system available from Novell, Inc.; (c) a Macintosh operating system
available from
Apple Computer, Inc.; (d) a UNIX operating system, which is available for
purchase from many
vendors, such as the Hewlett-Packard Company, Sun Microsystems, Inc., and AT&T

Corporation; (e) a LINUX operating system, which is freeware that is readily
available on the

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36
Internet; (f) a real time VxWorks operating system from WindRiver Systems,
Inc.; or (g) an
appliance-based operating system, such as that implemented in handheld
computers or personal
digital assistants (PDAs) (e.g., PalmOS available from Palm Computing, Inc.,
and Windows CE
available from Microsoft Corporation). Operating system 212 essentially
controls the execution
of other computer programs, such as infusion system 210, and provides
scheduling, input-
output control, file and data management, memory management, and communication
control
and related services.
Infusion system 210 can be a source program, executable program (object code),
script,
or any other entity comprising a set of instructions to be performed. When a
source program,
the program is translated via a compiler, assembler, interpreter, or the like,
that may or may not
be included within the memory 204, so as to operate properly in connection
with the 0/S 212.
Furthermore, the infusion system 210 can be written as (a) an object-oriented
programming
language, which has classes of data and methods, or (b) a procedural
programming language,
which has routines, subroutines, and/or functions, for example, but not
limited to, C, C++,
Pascal, Basic, Fortran, Cobol, Pen, Java, and Ada. In one embodiment, the
system program
210 is written in C++. In other embodiments, the infusion system 210 is
created using Power
Builder. The I/O devices 206 can include input devices, for example, but not
limited to, a
keyboard, mouse, scanner, microphone, touch screens, interfaces for various
medical devices,
bar code readers, stylus, laser readers, radio-frequency device readers, etc.
Furthermore, the I/0
devices 206 can also include output devices, for example, but not limited to,
a printer, bar code
printers, displays, etc. The I/0 devices 206 can further include devices that
communicate as
both inputs and outputs, for instance, but not limited to, a
modulator/demodulator (modem; for
accessing another device, system, or network), a radio frequency (RF) or other
transceiver, a
telephonic interface, a bridge, a router, etc.
If the computer 200 is a PC, workstation, personal digital assistant, or the
like, the
software in the memory 204 can further include a basic input output system
(BIOS) (not shown
in FIGURE 2). The BIOS is a set of essential software routines that initialize
and test hardware
at startup, start the 0/S 212, and support the transfer of data among the
hardware devices. The
BIOS is stored in ROM so that the BIOS can be executed when the computer 200
is activated.
When the computer 200 is in operation, processor 202 is configured to execute
software
stored within memory 204, to communicate data to and from memory 204, and to
generally
control operations of the computer 200 pursuant to the software. The infusion
system 210 and
the 0/S 212, in whole or in part, but typically the latter, are read by
processor 202, perhaps
buffered within the processor 202, and then executed.

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When the infusion system 210 is implemented in software, as is shown in FIGURE
2,
the infusion system 210 program can be stored on any computer-readable medium
for use by or
in connection with any computer-related system or method. As used herein, a
computer-
readable medium is an electronic, magnetic, optical, or other physical device
or means that can
contain or store a computer program for use by or in connection with a
computer related system
or method. The infusion system 210 can be embodied in any computer-readable
medium for
use by or in connection with an instruction execution system, apparatus, or
device, such as a
computer-based system, processor-containing system, or other system that can
fetch the
instructions from the instruction execution system, apparatus, or device and
execute the
instructions. In the context of this document, a "computer-readable medium"
can be any means
that can store, communicate, propagate, or transport the program for use by or
in connection
with the instruction execution system, apparatus, or device. The computer-
readable medium
can be, for example, but not limited to, an electronic, magnetic, optical,
electromagnetic,
infrared, or semiconductor system, apparatus, device, or propagation medium.
More specific
examples (a non-exhaustive list) of the computer-readable medium would include
the
following: an electrical connection (electronic) having one or more wires, a
portable computer
diskette (magnetic), a random access memory (RAM) (electronic), a read-only
memory (ROM)
(electronic), an erasable programmable read-only memory (EPROM, EEPROM, or
Flash
memory) (electronic), an optical fiber (optical), and a portable compact disc
read-only memory
(CDROM) (optical), Note that the computer-readable medium could even be paper
or another
suitable medium upon which the program is printed, as the program can be
electronically
captured via, for instance, optical scanning of the paper or other medium,
then compiled,
interpreted or otherwise processed in a suitable manner if necessary, and then
stored in a
computer memory.
In another embodiment, where the infusion system 210 is implemented in
hardware, the
infusion system 210 can be implemented with any, or a combination of, the
following
technologies, that are each well known in the art: a discrete logic circuit(s)
having logic gates
for implementing logic functions upon data signals, an application specific
integrated circuit
(ASIC) having appropriate combinational logic gates, a programmable gate
array(s) (PGA), a
field programmable gate array (FPGA), etc.
Any process descriptions or blocks in figures, such as FIGS. 3-11, are to be
understood
as representing modules, segments, or portions of hardware, software, or the
like, that can
include one or more executable instructions for implementing specific logical
functions or steps
in the process, and alternate implementations are included within the scope of
the embodiments

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38
in which functions can be executed out of order from that shown or discussed,
including
substantially concurrently or in reverse order, depending on the functionality
involved, as would
be understood by those having ordinary skill in the art.
Patient Care System Components
FIGURE 4 is a first block diagram showing functional components of the patient
care
system 100 of FIGURE 1. As shown in FIGURE 4, the patient care system 100 can
be
practiced as a modular system where the modules represent various functions of
the patient care
system, including the infusion system 210 (FIGURE 2). The flexibility of the
patient care
system 100 and the infusion system can be enhanced when the systems are
practiced as modular
systems. The modules of the infusion system 210 (FIGURE 2) can be included in
various
portions of the patient care system 100. In an embodiment, the patient care
system functional
components can include, inter alia, a medication management module 302, a
prescription
generation module 304, a prescription activation module 306, and a
prescription authorization
module 308.
The medication management module 302 can coordinate the functions of the other
modules in the patient care system 100 that are involved in the administration
of medical
treatment. The medication management module 302 generally coordinates with
other portions
of the patient care system 100. The medication module 302 can include sub-
modules for
operating and/or interfacing with a CPOE, for operating and/or communicating
with point-of-
care modules, and for operating and/or communicating with medical treatment
comparison
modules. In FIGURE 4, an admissions, discharge, and transfer (ADT) interface
310, a billing
interface 312, a lab interface 314, and a pharmacy interface 316 are shown.
The ADT interface
310 is used to capture infoiniation such as the patient's demographics, size,
weight, and
allergies. In a preferred embodiment, the ADT system utilizes an HL7 type of
interface to
transfer events that are entered into the hospital's ADT system into the
second central server
108a. HL7 is a protocol for formatting, transmitting and receiving data in a
healthcare
environment. It provides interoperability between healthcare information
systems through a
messaging standard that enables disparate healthcare applications, such as a
variety of different
third-party applications, to exchange key sets of clinical and administrative
data. Typically, in
the present system 100, the HL7 ADT interface consists of three applications:
the HL7 ADT
server, the HL7 ADT client, and the HL7 ADT viewer. The pharmacy interface 316
imports
orders from the pharmacy. The pharmacy interface 316 can be an HL7-type of
interface that
interfaces with other systems for entering orders, such as a CPOE. This
ability reduces the
necessity for entering data into the patient care system 100 more than once.
The pharmacy

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39
interface 316 can be configured to communicate with commercially available
third-party
systems such as, but not limited to Cerner, HBOC, Pyxis, Meditech, SMS,
Phamous, and the
like. A web services interface can provide near real-time coordination between
Point of Care
medication management systems supporting oral medication dosing such as
McKesson
AdminRx, Pyxis Verif5, etc. and infusion pump related medication management.
Various other
interfaces are also known to those having ordinary skill in the art, but are
not shown in FIGURE
4.
The medication management module 302 can have additional features such as the
ability to check for adverse reactions due to drug-to-drug incompatibility,
duplicate drug
administration, drug allergies, drug dosage limitations, drug frequency
limitations, drug
duration limitations, and drug disease contraindications. Food and alcohol
interactions can also
be noted. Drug limitations can include limitations such as, but not limited
to, limitations
associated with adults, children, infants, newborns, premature births,
geriatric adults, age
groupings, weight groupings, height groupings, and body surface area. In an
embodiment, the
medication management module 302 prevents the entry of the same prescription
for the same
patient from two different sources within the patient care system 100.
The medication management module 302 can also include the ability to generate
reports. The reports include, but are not limited to, end-of-shift, titration
information, patient
event lists, infusion history, pump perfoimance history, pump location
history, and pump
maintenance history. The end-of shift report can include the pump channel,
start time, end time,
primary infusion, piggyback infusion, medication, dose, rate, pump status,
volume infused,
volume remaining, time remaining, and the last time cleared. The infusion
history report
includes medications and volume infused.
The medication management module 302 can also include a medical equipment
status
database. The medical equipment status database includes data indicating the
location of a
medical device 332 within the patient care system 100. The medical equipment
status database
can also include data indicating the past performance of a medical device 332.
The medical
equipment status database can also include data indicating the maintenance
schedule and/or
history of a medical device 332,
Infusion prescriptions or orders are entered in prescription entry 324. Such
orders can
include prescriptions such as, but not limited to, single dose infusions,
intermittent infusions,
continuous infusions, sequencing, titrating, and alternating types. Infusion
prescriptions can
also include total parenteral nutritional admixtures (TPN), chemotherapy
continuous infusion,
piggybacks, large volume parenterals, and other infusion prescriptions. The
patient care system

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100 can function without end dates for orders. The patient care system 100
uses a continuous
schedule generator that looks ahead a predefined time period and generates a
schedule for
admixture filling for the time period. The predefined time period can be
defined at the patient
care system 100 level or at subsystem levels such as the clinical discipline
level and an
5 organizational level. The predefined time periods can be adjustable by
the clinician 116
entering the order. The schedule can be automatically extendable as long as
the order is active
in the patient care system 100.
The prescription generation module 304 generates hard prescriptions and
electronic (E-
copy) prescriptions. Hard prescriptions are generally produced in triplicate
in medical facilities.
10 A first hard copy 318 is generally sent to the pharmacy, a second hard
copy 320 is generally
kept for the patient's records, and a third hard copy 322 is sent to treatment
location 106. An
electronic prescription is sent to the medication management module 302.
Prescription generation module 304 can include confirming operating
parameters. The
operating parameters can be based on information from prescription entry
module 324.
15 Prescription generation 304 can occur anywhere in the patient care
system 100 such as, but not
limited to, the pharmacy, the treatment location 106, and a nursing center.
A computerized physician order entry (CPOE) system or the like can be employed
to
carry out some or all of the functions of the prescription generation module
304. Clinicians
116 can enter data in a variety of manners such as, but not limited to, using
a tablet wireless
20 computer, personal digital assistant, treatment cart 132, and a
workstation. The medication
management module 302 can interface with more than one prescription generation
module 304.
The medication management module can receive orders from anywhere within the
patient care
system 100.
The pharmacy computer 104 is able to access the electronic copy from the
medication
25 management module 302. The prescription activation module 306 is a
computer-assisted
system for coordinating the filling and labeling of prescriptions. The filling
of the prescription
and the creation or location of medication 124 from stock is handled by the
prescription
activation module 306. In an embodiment, the filling process results in the
creation of the
medication label 124a, as opposed to the prescription activation process.
30 The patient care system 100 can bypass the prescription activation
module 306. This
can occur if the ordering clinician 116, such as the patient's physician, has
the authority to
immediately activate an order. If the order is immediately activated, the
medication
management module 302 can go directly to filling and, thus, the prescription
labeling module
326.

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In block 326, the patient care system 100 prints the medication label 124a.
The
prescription can be printed remotely and will often be printed by the pharmacy
printer 104d.
After block 326, the patient care system goes to block 328. In block 328, the
medication label
124a is attached to the medication 124. The pharmacist generally provides a
visual verification
334 that the medication label 124a matches the first hard copy 318 of the
prescription. FIGURE
4 shows that a visual verification 334 is also associated with prescription
authorization module
308. The medication 124 can then be transported from the pharmacy to the
treatment location
106. A portable medical treatment cart 132 can be used for a portion of the
route from the
pharmacy to the treatment location 106.
The medication label 124a can include information for preparing the infusion
bag. If
not generated within patient care system 100, medication label 124a can be
provided by a bulk
medication supplier. If provided by a bulk medication supplier, the patient
care system 100
gathers the information from the medication label 124a. In addition, the
patient care system 100
can add information, such as a patient identifier, to the medication label
124a.
The medication labeling module 328 places the medication label 124a on the
medication
124. This can be accomplished manually. This can also be accomplished using an
automatic
prescription filling and packaging system (not shown). If an automatic filling
and packaging
system is used, medication labeling module 328 provides data for coordination
of the labeling
of the medication 124 to the filling and packaging system.
At the treatment location 106, the clinician 116 uses a wireless device 330,
such as
digital assistant 118 and/or medical treatment cart 132, to verify and
administer medication 124
to the patient 112. Wireless device 330 communicates with the medication
management
module 302 via a communication path, such as first communication path 126.
Clinician 116 identifies him/herself by scanning badge 116a, identifies the
patient 112
by scanning wristband 112a, identifies the medication 124 by scanning
medication label 124a,
and identifies the medical device 332, such as infusion pump 120, by scanning
label 120d.
Clinician 116 can also identify him/herself by providing a fingerprint and/or
password as
described above and shown in the login screen 503 of FIGURE 19. The medical
device 332 can
be a medical device capable of two-way communication with the medication
management
module 302. Alternatively, the medical device 332 can only be capable of
providing
information to the medication management module 302. The infusion system 210
assists the
clinician 116 in administering and verifying the medical treatment. In an
alternate embodiment,
the infusion system 210 can include downloading of operating parameters to the
medical device
332. Clinician 116 can provide a visual verification to confirm the third copy
322 and/or the

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42
MAR matches the labeled medication 124. Scanner 338 can be used to enter
machine readable
information from the third copy 322 to the wireless device 330 and the medical
device 332.
The patient care system 100 can make adjustments and modifications to infusion
orders.
Among other modules that can include the ability to make infusion adjustments
are prescription
entry 324, prescription activation 306, prescription authorization 308, and
prescription
modification module 336. Clinician 116 accesses the prescription modification
module 336 in
order to make adjustments to an order. The clinician 116 can access the
prescription
modification module 336 throughout the patient care system 100. However, one
very useful
location for clinician 116 to access the prescription modification module 336
is at treatment
location 106.
In prescription authorization module 308, the patient care system 100
determines
whether the clinician 116 has the authority to independently modify an
infusion order. The
clinician 116 can be recognized by the patient care system 100 as having the
authority to
independently modify certain portions of the order. If the clinician 116 does
not have the
authority to independently modify the order, a pharmacist or physician can be
requested to
approve the modification entered by the clinician 116.
In one implementation of patient care system 100, an order is entered in
pharmacy
computer 104. The order includes a first patient identifier and an operating
parameter. The
pharmacy computer 104 generates a medication label 124a that is affixed to the
medication bag
or container. The medication 124 is sent to a treatment location 106. At
treatment location 106,
clinician 116 reads the clinician's badge 116a, patient's wristband 112a, and
medication label
124a with a digital assistant 118. The digital assistant 118 reports, based on
a determination
made by the central system 108, whether medication label 124a and wristband
112a correspond
to the same patient 112. The system 100 then sends the medication identifier
to the pharmacy
computer 104. The pharmacy computer 104 confirms the medication label 124a,
identifies the
same patient as the order, and sends the operating parameter to an infusion
pump. The
operating parameter can be sent directly to the infusion pump 120. The
operating parameter is
then used to program the infusion pump to administer the medication 124 to the
patient 112.
FIGURE 5 is an exemplar block diagram of a computer screen 400 that is useful
in
implementing various functions of the infusion system 210 (FIGURE 2). In
addition to other
functions, the computer screen 400 can be used to enter new infusion orders,
to modify existing
infusion orders, and to stop infusion orders. Computer screen 400 preferably
includes a
processing area 402, search areas 404, a medication information area 406, a
titration/tapering
criteria area 408, an instruction and note area 410, and a projected solution
ingredient area 412.

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Infusion medication order types include single dose, intermittent, continuous,
sequencing, and
alternating. Computer screen 400 can be used with digital assistant 118,
pharmacy computer
104, infusion pump 120, a CPOE system, and medical treatment cart 132.
Computer screen 400
is generally designed to have the look-and-feel of clinician accessible
computer screens
throughout the patient care system 100 of FIGURE 1. The functions of computer
screen 400
are partially accomplished with database linkage techniques familiar to those
having ordinary
skill in the art such as, but not limited to, hyperlinks, definition boxes,
and dropdown menus.
The processing area 402 includes the ability to trigger the creation of an
infusion order,
a save of an infusion order, the modification of an infusion order, and a
cancellation of an
infusion order. Clinician 116 can customize the computer screen 400 to provide
the clinician's
116 preferred order entry procedures. The processing area 402 includes a
status indicator for
orders. The processing area 402 also includes an area for indicating whether a
PRN order ("as
required" or "when needed" order) can be placed by clinician 116. The
processing area 402
further includes the ability to display and adjust medical device 332
operating parameters,
infusion order route, infusion line, infusion administration site, infusion
order start time,
infusion medication order type, infusion flow rate tolerance, infusion flow
rate, infusion
duration and area of preparation (such as pharmacy or a remote site). The
processing area 402
can also include an area for linking medical orders to other medical orders,
or associated
clinical monitoring, such as, linking a physician's infusion order to another
medical order
entered by another clinician 116. The processing area 402 can include a
trigger for displaying
data in other areas of the computer screen 400 such as, but not limited to,
the projected solutions
area 412.
Search areas 404 allow for searching for medications, solutions and/or
additives for
infusion orders. Default diluents can be provided for orders. If a default
dosage for a
medication is defined in the patient care system 100, the default dosage
automatically appears
with the search result that includes the medication. A search from search area
404 can result in
the display of the medication name, the route of administration, the cost, the
package size, the
dosage form, the generic name, whether the medication is a narcotic, whether
the medication is
controlled, whether formulary, and whether the medication is manufactured.
Medication information area 406 can be used to define infusion order additives
and
solutions. Medication information area 406 can include separate additive areas
and solution
areas. The solution area can include a label, "Solution/Diluents." The patient
care system 100
may use a medication 124 database, a solutions database, and an additive
database to populate
the medication information area 406 with medications 124, solutions, and
additives. Substances

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44
identified in one database may also be identified in other databases. The
databases may be
linked to provide default values for combinations of the medications 124 and
solutions.
Titration/tapering criteria area 408 generally applies to continuous infusion
orders.
Titration defines certain parameters of an order such as dosage and/or flow
rate. Dose and flow
rate can be entered as an absolute. Also, mathematical symbols such as, but
not limited to,
greater than ">," less than "<," and equal "=," can be used alone or in
combination to enter
information in titration/tapering criteria area 408. A calendar can also be
used to enter data in
titration/tapering criteria area 408. Dosage and flow rate can also be entered
as an acceptable
range. Titration/tapering criteria area 408 can be hidden when non-continuous
infusion orders
are entered and/or modified. The titration criteria can include values of
various parameters
related to patient condition such as, but not limited to, various lab results,
vital signs, ability to
take fluids orally, fluid input and output, and the like.
Instruction and note area 410 includes the ability to save information such as
physician
notes regarding a patient 112 and/or an infusion order. The instruction and
note area 410 can
include a display and lookup area for identifying clinicians 116 that are
responsible for the
patient 112, such as the patient's physician.
The projected solutions area 412 displays solution schedules and related
ingredients
based on the current state of the order being processed for patient 112. The
time period
projected can be a patient care system 100 default. The time period can also
be adjustable by
the clinician 116. The projected solutions area 412 can include an adjustable
display indicating
the time period projected by the patient care system 100. The data displayed
in the projected
solutions area 412 is generally saved when an order save is triggered in the
processing area 402.
The projected solutions area 412 can include the ability to look back over a
period of time while
modifying a previously entered order. This allows the clinician 116 to view
solutions that may
have already been prepared according to the unmodified infusion order.
Infusion System Components
FIGURE 6 is a block diagram showing functional components of the infusion
system
210 of FIGURE 2. The functional components include blocks for setting system
parameters
502, infusion order creation 504, infusion order preparation 506, medication
administration 512,
infusion order modifications 514, and messaging 520. FIGURE 6 also includes
blocks for
pharmacy authorization 508, physician authorization 510, stop orders 516, and
inventory and
billing 518. FIGURE 6 presents one description of the infusion system.
However, FIGURE 6
does not define a required series of processes for implementing the infusion
system. One of the
benefits of the infusion system is that a clinician 116 can access and enter
information from a

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large number of locations, both physical and functional, within the patient
care system 100. For
example, an infusion order can be created by a physician using a CPOE, by a
phainiacist using
phainiacy computer 106, by a clinician 116 using digital assistant 118, and by
a clinician using
medication treatment cart 132. Moreover, vitals, lab results, and other
records of patients can
5 be
checked from a large number of locations within the health care facility
including, for
instance, the inpatient pharmacy. Accordingly, a user within the inpatient
pharmacy 104
(FIGURE 1) can view, from a computing device 104c, the wards within the health
care facility.
Upon selection of a ward by the user, a patient list is provided wherein the
user can select a
patient and associated records for display on the computing device.
Alternatively, the user can
10 enter
all or part of the patient's name into the computing device, whereby the
records associated
with the patient are provided by the computing device for selection by the
user. Upon selection,
the record(s) is displayed.
In an embodiment, FIGURE 6 can be viewed as first preparing the patient care
system
100 for receiving infusion orders ¨ setting system parameters 502; second,
creating the infusion
15 order ¨
infusion order creation 504; third, preparing the infusion order ¨ preparation
506;
fourth, authorizing the infusion order ¨ pharmacy and physician authorization
508 and 510;
fifth, administering the infusion order ¨ medication administration 512;
sixth, accounting for
and replenishing the inventory used to prepare the infusion order and billing
the patient for the
infusion order ¨ inventory and billing 518; seventh, modifying the infusion
order -
20
modifications 514; and eighth, providing messages to various personnel and sub-
systems
regarding the progress of the infusion order, infusion, messages for assisting
in ensuring that the
right medication is efficiently prepared and provided to the right patient, in
the right dose and at
the right time, or the like ¨ messages 520. Modifications 514 can include
stopping the order ¨
stop order 516 ¨ based on information provided by the transfer interface 310.
25 Setting
system parameters 502 includes functional blocks that prepare the infusion
system 210 to create and process infusion orders. Setting system parameters
502 includes, but
is not limited to, setting tolerances 542, setting defaults 544, building
databases 546, defining
functions 548, and determining system settings 550. Setting system parameters
502 is further
described below in reference to FIGURE 7.
30 Infusion order creation 504 includes functional blocks used to
create infusion orders.
Infusion order creation 504 includes functions similar to those described in
reference to
prescription generation 304 (FIGURE 4). Infusion order creation 504 includes,
but is not
limited to, entering information 560, calculations 562, checks 564, and
overrides 568. Infusion
order creation is further described below in reference to FIGURE 8. The result
of infusion

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order creation is an infusion order 702 (FIGURE 8). Infusion order 702
generally includes an
infusion schedule 704 (FIGURE 8).
Infusion orders can require authorization as described in reference to block
308
(FIGURE 4). In FIGURE 6, prescription authorization by the pharmacist and
prescription
authorization by the physician are considered separately in functional blocks
for pharmacy
authorization 508 and physician authorization 510. Physician authorization 510
may not be
required if the infusion order is initiated by the physician. The infusion
order generally requires
pharmacy authorization 508 and physician authorization 510 if the order is
generated by a
clinician at the treatment location 106, other than the pharmacist or
physician. However, if
medication 124 is required immediately, the infusion system 210 allows
administering
clinicians to bypass prescription authorization 508 and physician
authorization 510. In the case
of emergency orders or non-emergency orders for routine medications, the
infusion system 210
can determine there is no information stored in the patient care system 100
related to the
medical treatment the clinician 116 desires to administer to the patient 112.
If the infusion
system 100 recognizes the clinician 116 as having the authority to initiate
the desired medical
treatment, the system 210 allows for the administration of the medical
treatment without going
to blocks 508 and 510. This authorization is then obtained following
administration.
Infusion order preparation 506 can be accomplished in a number of locations
throughout
the medical facility such as, but not limited to, the pharmacy, the nursing
center, on the floor,
and the treatment location 106. Preparation 506 includes providing
instructions for preparing
the medication 124 and minimizing the possibility of errors in medication
preparation.
Medication administration 512 takes place at the treatment location 106. The
infusion
system 210 is designed to make the administration of the order as efficient
and accurate as
possible. The infusion system 210 provides the administrating clinician with
the tools to
administer the right medication to the right patient in the right dose, with
the right pump
settings, at the right time, and via the right route. Should an alert, alarm,
reminder, or other
message be appropriate in assisting the clinician with the administration of
the medication, the
medication administration module provides a status information output to the
messaging
module 520. In response to the status information output, the messaging module
520 forwards
a related text message, audible indicator enable, or both, to one or more
electronic computing
devices.
As known by those having skill in the art, infusion orders are frequently
modified.
Infusion system 210 provides modifications 514 to account for infusion order
modifications.
Modification 514 includes modifications to infusion duration, flow rate,
infusion site, and stop

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orders 516. Modification 514 also includes the functional blocks required to
implement
infusion order modifications.
The infusion system 210 can include patient care system wide 100 defined stop
orders
516. Changes in patient status may generate messages 520 for appropriate
action. The infusion
system 210 coordinates with the transfer interface 310 to automatically stop
orders 516 upon
discharge or death.
The system 100 includes inventory and billing module 518. Inventory and
billing 518
allows the financial transactions associated with patient care to proceed with
a minimum of
human intervention. The completion of medication administration 512 can
trigger patient
billing through the billing interface 312. The billing interface can include
an BL7 interface. If
patients are to be charged based on completion of infusion order preparation
506, the inventory
and billing system 210 includes a crediting process. The crediting process can
be triggered
when infusion bags are returned to the pharmacy for disposal or re-entry into
the pharmacy
inventory management system.
The infusion system 210 includes a messages module 520 for communicating with
entities throughout the patient care system 100. In particular, the messages
module 520 sends
text messages, audible indication enables, or both, to one or more electronic
computing devices
within the patient care system 100. The messages are sent in response to a
status information
output provided by the medication administration module or other infusion
system modules
within the patient care system 100. The messages relate to the status
information output and, as
such, provide alerts, alarms, reminders, or other messages appropriate in
assisting the clinician
with medication administration.
For example, when a physician enters a new order, messaging appears in the
pharmacy
to alert the pharmacists that an infusion order requires authorization.
Likewise, when infusion
orders are appropriately authorized, the clinician 116 receives messaging on
digital assistant
118 to alert the clinician 116 that the infusion order should be administered
according to the
infusion schedule 704. Overrides 566 may generate messages 520 for the
physician and/or the
pharmacy. The infusion system 100 can distinguish between system-wide and sub-
system
overrides in determining whether it is necessary to generate a message 520.
Messaging 520
includes messages received and/or sent to the central system, the pharmacy,
the physician,
billing, and inventory.
The system can present clinicians 116 with personal computer display views.
The
personal computer display provides a view summarizing outstanding clinical
problems for the
clinician's patients. The clinician 116 can quickly retrieve detailed
infounation for the patients.

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The system 100 can also produce an email or page to digital assistant 118, or
other
communication device, when certain critical patient conditions prevail.
FIGURE 6 also depicts some of the communication paths that occur in patient
care
system 100. The highlighted communication paths are presented for ease in
describing the
infusion system 210. Those having ordinary skill in the art recognize that,
when patient care
system 100 is practiced on a network, the various functional blocks can
communicate with each
other via the paths highlighted in FIGURE 6 and via alternate paths that are
not shown in
FIGURE 6. Setting system parameters 502 includes communicating data related to
the system
parameters to infusion order creation 504, via path 522, and/or receiving data
from infusion
order creation 504 and providing data informing infusion order creation 504 of
how the
received data relates to the system parameters.
Infusion orders can be passed directly, via path 524, to infusion preparation
506.
Infusion orders can also be passed to pharmacy authorization 508, via path 526
and/or to
physician authorization, via path 528, before being sent to preparation 506.
Path 530 highlights
the delivery of the medication 124 from the preparation area to the treatment
location 106.
Delivery can be accomplished using medication treatment cart 132. Paths 532,
534, 536, and
538 highlight that inventory and billing 518 transactions can be tied to a
variety of other
functions such as, but not limited to, infusion order creation 504,
preparation 506, medication
administration 512, and modifications 514. Paths 572, 574, and 576 highlight
that a larger
number of functions and actors involved in patient care system 100 can
generate and receive
information via messages 520. Path 582 highlights that system defaults 544 can
be created
and/or modified by the pharmacist. And, path 580 highlights that information,
such as infusion
orders, is available to a variety of functional units throughout the system
100.
FIGURE 7 is a block diagram showing functional components for the setting of
system
parameters 502 of FIGURE 6. Setting system parameters 502 includes, but is not
limited to,
setting tolerances 542, setting defaults 544, building databases 546, defining
functions 548, and
determining system settings 550. Tolerances 542 include tolerances such as,
but not limited to,
net medication tolerances 542a, flow rate tolerances 542b, administration time
tolerances 542c,
administration system duration 542d, medication duration tolerances 542e, and
site change
tolerances 542f. The infusion system 210 can also include separate tolerances
for order entry
and modifications from the ordered tolerances. For example, separate
tolerances can be
identified such as, but not limited to, an administration system duration
542d, an order entry
maximum infusion duration override availability setting, and an administration
maximum
infusion duration override availability setting.

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A net medication tolerance 542a is a maximum concentration of a medication
that is
safe to administer to a patient during a given period of time. The infusion
system 210
associates the net medication tolerances with medications. Net medication
tolerances 542a can
be defined in medication identification files in a medication database. During
infusion order
creation 504, the infusion system 210 can deteimine the flow rate 560e, the
number of infusion
bags required 562a for a specified period of time, the concentration of the
primary ingredient in
each infusion bag, the time period over which each infusion bag is to be
administered, and the
total volume of each infusion bag. Flow rates can be manually entered or
adjusted by altering
the final concentration or the duration of each infusion bag. In an
embodiment, the infusion
system 210 performs a net concentration check 564a (FIGURE 8) to ensure the
maximum
concentration of the medication is not exceeded. However, if at any time while
a clinician 116
is modifying the flow rate by adjusting the final concentration resulting in
the final
concentration of a solution exceeding the maximum concentration of the
medication, the
infusion system 210 sends a message 520 to the administering clinician. The
administering
clinician can be authorized to override the net medication tolerance 542a. The
infusion system
210 can require the clinician 116 to provide a reason for the override.
Infusion system 210 can include adjustable flow rate tolerances 542b and flow
rate
adjustment tolerances for administration. Flow rate tolerances 542b are
optionally defined for
all organizational levels of the patient care system 100. The tolerances 542b
can be for the
entire patient care system 100, or for sub-systems of the patient care system
100. For example,
different flow rate tolerances 542b can apply to sub-systems such as, but not
limited to,
neonatal, pediatric, psychiatric, specific nursing units, and for specific
patients. The flow rate
tolerances 542b can be specified relative to the original ordered flow rate or
relative to the
immediately preceding flow rate. The clinician 116 can also specify a flow
rate tolerance
specific to a particular order.
The infusion system 210 can include a pre-defined indication of whether the
administering clinician 116 is permitted to override the flow rate tolerance
542b without
requiring a new order. This indication can apply to the entire patient care
system 100, a sub-
system, or an individual clinician 116.
The maximum infusion duration 542d can be separately definable for the various
portions of the patient care system 100. The maximum infusion duration 542d
can also be
specific to a particular medication 124. A maximum infusion duration override
566 (FIGURE
8) can be provided if it is permissible to override the maximum infusion
duration 542d at the
time of order entry. An administration maximum infusion duration override can
be provided to

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set whether it is permissible to override the maximum infusion duration 542d
at the time of
administration and which group of users is allowed to do so. If it is
permissible to override
during order entry and/or administration, the infusion system 210 can define a
subset of the
clinicians 116 that have the authority to override the maximum infusion
duration 542d.
5 Defaults 544 include defaults such as, but not limited to, medication
diluents defaults
544a, diluents quantity defaults 544b, dose defaults 544c, and units of
measure defaults 544d.
Units of measurement (UOM) defaults 544d include the ability to specify the
units of
measurement that are most suitable for different portions of the patient care
system 100. For
example, medication can be measured in different units by physicians,
administering clinicians,
10 pharmacists, financial personnel, and medication screeners. The
physician's UOM is generally
a measurable value such as "mmol," "mEq," "ml," and/or "mg," as opposed to
"vial" and/or
"puff." The physician's UOM is used for tasks such as ordering and entering
information 560.
The administering clinician's UOM is generally a value that reflects the UOM
the
medication will be administered in, such as "puff," "tbsp," and "tab." The
administering
15 clinician's UOM is used during medication administration 512. The
administering clinician's
UOM can also appear on documentation such as administration reports, admixture
fill and
manufacturing work orders.
The pharmacy UOM is generally a value that reflects the physical faun the
medication
is dispensed in such as "tab," "vial," "inhalator," and "jar." The pharmacy
UOM is used in
20 preparation 506 and in stocking and dispensing systems. The financial
UOM is generally a
value used to calculate the financial figures that appear on bills and
invoices. The medication
screening UOM is generally used when screening the medication.
Units of measurement defaults 544d can be specified using a check-box table
where
checkmarks are placed in a table correlating the various UOMs with the users
of the UOMs.
25 The infusion system 210 can use the same UOM for more one function. For
example, the
physician's UOM can be the same as the phainiacist's UOM. Setting defaults 544
include data
necessary to coordinate the various UOMs. For example, UOM defaults 544d can
include the
multipliers and dividers necessary to create a one-to-one correspondence
between the various
UOMs. The UOM defaults 544b can be changed to suit the desires of the
individual clinicians.
30 However, the one-to-one correspondence should be maintained by the
patient care system 100.
The infusion system 210 can be designed to maintain a history of medication
unit defaults.
The infusion system 210 can also include medication measurement suffixes. The
medication measurement suffixes can default during order entry. The medication
measurement
suffixes can be common units of measuring a medication and can include units
related to patient

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characteristics such as body surface area and weight. Medication measurement
suffixes can be
designated per drug, per order type, per dose, and per UOM.
Building database 546 includes building databases and/or portions of a single
database
such as, but not limited to, preparation area 546a, additive information 546b,
solution 546c, pre-
mix definitions 546d, favorites 546e, timing override reasons 546f, flow rate
override reasons
546g, translation tables 546h, flow rate description 546i, equipment and
routing information
546j, and message trigger 546k.
Timing override reasons 546f include displayable reasons for modifying the
timing of
infusion orders. For example, timing override reasons 5461 can include a
stylus-selectable
reason for digital assistant display 118a for administering an infusion order
at a time other than
the time specified in the original infusion order. If the clinician 116
administers a medication
outside the ordered administration time tolerance 542c, the clinician 116 can
be required to
choose a reason code for the modification from displayed reasons 1008f (FIGURE
11).
Examples of other reason codes include, but are not limited to, PRN
administration reason
codes and codes for stopping an infusion.
Medications 124 and/or infusion orders can have,flow rate tolerances,
including system
flow rate tolerances 542b. The infusion system 210 can include flow rate
override reasons table
546g. Flow rate override reasons 546g are notations that the clinician 116 can
choose from,
and/or supply, if the clinician 116 needs to change the flow rate beyond the
bounds defined by
the flow rate tolerance 542b. The infusion system 210 can include a defined
message trigger
546k indicating whether or not a message should be sent to the patient's
physician if a clinician
116 overrides an order-defined flow rate tolerance. The infusion system 210
can also include
defined message triggers 546k indicating whether or not a message should be
sent, and to
whom, if a clinician 116 overrides a tolerance, such as flow rate tolerances
542b, defined at a
level other than the order.
The infusion system 210 can include translation tables 546h such as, but not
limited to,
a flow rate translation table, a varying ingredient translation table, and
varying flow rate
translation table. Flow rate translation includes translating an infusion
order into a flow rate
defined by volume/time where the order is originally specified in any way such
as, but not
limited to, dosage/time with a particular concentration, volume per unit of
weight/time, dosage
per unit of body surface area/time, and total dosage and duration.
Varying ingredient translation includes translating a plurality of flow times
of infusion
orders with varying ingredients in separate infusion bags into the flow rate
for the infusion bag
currently being administered. Orders with varying ingredients include orders
such as, but not

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52
limited to, sequencing orders. In sequencing orders, different bags have
different ingredients
and potentially different flow rates.
Varying flow rate translation includes translation of infusion orders with
varying flow
rates into the flow rate for the current solution being infused. Varying flow
rate orders include
orders such as, but not limited to, bolus/basal, orders, tapering dose orders
and alternating dose
orders.
The infusion system 210 can include predefined infusion flow rates 542b. The
predefined infusion flow rates 542b can be associated with flow rate
descriptions 546i to permit
selection from a drop-down list as a shortcut from keying in the flow rate.
Defined functions 548 include functions such as, but not limited to,
preparation area
function 548a, bag duration function 548b, verify override requests function
548c, duration to
volume function 548d, duration to flow rate function 548e, and flow rate to
drip rate function
548f. The infusion system 210 can include a duration-to-volume function 548d
to determine the
amount to be infused per the infusion order. Flow rate to drip rate function
548f uses
information about the medical device 330 to convert flow rates to drip rates.
Determined settings 550 include settings such as, but not limited to, override
authorities
550a, flow rate precision 550b, volume precision 550c, and time precision
550d. The infusion
system 210 can, if desired, determine the total volume of infusions and the
flow rate(s) of the
infusion order. If these numbers are determined, it is desired to round the
calculated values to
flow rate precisions 550b and volume precisions 550c that are comprehensible
to clinicians 116
such as the physician, the pharmacist, and the nurse. Flow rate display
precision 550b can be
set to display the flow rate to a set number of decimal places. Various parts
of the patient care
system 100 can independently determine the precision for displayed flow rates.
For example,
the infusion system 210 can display to one decimal place for an adult
treatment location, and to
three decimal places for a neonatal treatment location. The flow rate
precision 550b reflects the
service in which the clinician's patient(s) are located. The flow rate(s) of
the infusion order can
be rounded to a system-defined precision. The precision can be same for all
infusion orders or
be dependent on the patient's service.
Volume display precision 550c can similarly be set to display infusion volumes
to a set
number of decimal places. Settable time precision 550d can be used to
calculate the
administration duration period based on flow rate if the infusion is a single
dose infusion or an
intermittent infusion. The total volume of each infusion bag calculated is
rounded according to
the volume precision 550c. The administration time is rounded by the infusion
system 210
according to the set time precision 550d. The time precision 550d can be the
same for all

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infusion orders regardless of the patient's service or may be service-
specific.
Order Creation
FIGURE 8 is a block diagram showing functional components for infusion order
creation 504 of FIGURE 6. Infusion order creation 504 includes functional
blocks for creating
infusion orders. Infusion order creation 504 includes entering information
560, calculations
562, checks 564, and overrides 568. Entering information 560 can include
functions such as,
but not limited to, identifying the order type 560a, identifying the
medications 560b, identifying
the dose 560c, identifying the diluent 560d, identifying the flow rate 560e,
and identifying the
infusion site 560f.
Infusion order creation 504 is linked to infusion bag preparation 506,
infusion bag
delivery (path 530), medication administration 512, and infusion order
modifications 514.
Infusion order types 560a include order types such as, but not limited to,
single dosing, load
dosing, intermittent dosing, and continuous. Continuous infusions include
alternating infusions,
sequencing infusions, tapering infusions, and titrating infusions. Upon
selection of the first
medication 560b in an infusion order, an infusion order type 560a form for the
medication may
default. The ordering clinician can have the option of selecting a different
order type. The dose
560c and unit of measure 544d can also default. The unit of measure 544d can
be correlated
with the medication and/or the dose 544c. The infusion system 210 can include
a default
diluent, or several default diluents, for the medication. One default can be
identified as a
preferred diluent. A description can be associated with the diluent to assist
the ordering
clinician to decide which diluent to select. The diluent description can
include a reference
avoiding use of a particular diluent if a patient is hypertonic.
The infusion system 210 can also allow additional infusion order subtypes 560a
based
on the previously mentioned infusion order types. Additional infusion order
subtypes 560a can
include, but are not limited to, TPN infusion orders, chemotherapy continuous
infusion orders,
piggyback infusion orders, and large volume parenteral infusion orders. The
infusion order
subtypes can be accessed from different parts of the infusion system 210
allowing sorting and
filtering of infusion orders according to the subtypes. A special label format
for each infusion
order subtype can also be defined to further customize infusion order subtype
orders and
associated pharmacy workflow.
When searching for a medication 124 during infusion order creation 504, the
medication
124 can be flagged as additive and/or a solution to aid the clinician 116 in
creating the infusion
order. This designation can be made in a medication identification file.
Medication dose 560c can be determined in a number of ways such as, but not
limited

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to, according to body weight, body surface area, and entered according to
rate. When the flow
rate is not entered, the infusion system 210 calculates the flow rate
according to the dose and
time period specified. The ordering clinician can specify the diluent 560d and
its quantity. The
pharmacy can provide a default for such parameters ¨ see line 582 (FIGURE 6).
A check 564
can be performed to ensure the net concentration 564a for the medication 560b
and the flow rate
564b are appropriate.
The infusion system 210 can identify and/or calculate flow rates 560e based on
the
patient's weight, body surface area, and/or a specified frequency and duration
of therapy. The
ordered flow rate 560e is checked 564b against the flow rate tolerances, such
as system flow
rate tolerance 542b. The net concentration of the medication 124 can be
checked 564a against
net concentration tolerances, such as the system net concentration tolerance
542a.
In an embodiment, flow rate 560e can also include displaying descriptions of
default
flow rates to facilitate the entering of orders. Flow rate 560e can reference
flow rate
descriptions database 546i.
Calculations 562 can include calculating the dose based on patient weight
and/or height
(possibly provided by ADT interface 310), the drug amount, diluent volume,
concentration, or
rate. Calculations 562 can include, but are not limited to, calculating the
flow rate, if not
specified in the prescription, the bag quantity 562a or number of infusion
bags required for a
specified period of time, the time period over which each infusion bag is to
be administered,
and the total volume of each infusion and infusion bag based on the
concentration of the
ingredients in the solution. Flow rates, volume to be infused, and/or duration
can be modified.
If modified, the infusion system 210 automatically calculates dependent
quantities, based on
calculations, if the maximum dosage for the ingredients in the concentration
would be exceeded
as identified in the ingredient's medication file, the patient care infusion
system 210 alerts the
pharmacist and/or clinician 116 and can ask for a reason code for the
adjustment.
Calculations 562 can include calculations such as, but not limited to, bag
quantity
calculations 562a, translation calculations 562b, duration to volume
calculations 562c, and flow
rate to drip rate calculations 562d. Checks 564 include a variety of checks
that an infusion
order can be subject to. The checks include checks such as, but not limited
to, a net
concentration check 564a, a flow rate check 564b, an administration time check
564c, a
duration check 564d, and an infusion site check 564e. If an infusion order
fails a check 564, the
clinician 116 may be able to override the check. Overrides 568 can include
overrides such as,
but not limited to, a net concentration override 568a, a flow rate override
568b, an
administration time override 568c, a duration override 568d, and an infusion
site override 568e.

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Overrides 568 can generate messages 520 for the physician and/or the pharmacy.
The infusion
system 210 can distinguish between system-wide and subsystem overrides in
determining
whether it is necessary to generate a message 520.
Overrides can include an indication of whether clinicians have the authority
to override
5 a tolerance. For example, flow rate override 568b can provide an
indication of whether the
clinician entering the infusion order has the authority to override the system
flow rate tolerance
542b. This indication can apply to the patient care system 100 or a subsystem.
Duration
override 568d can provide an indication of whether the clinician 116 entering
the infusion order
has the authority to override the system duration 542d. This indication can
apply to the patient
10 care system 100 or a subsystem. Overrides 566 also include displaying of
reasons for the
override 568f. Reasons for the overrides 568f can be selected by the clinician
116 from drop-
down menus.
The result of the infusion order creation 504 is an infusion order 702.
Infusion order
702 can include an infusion schedule 704. The infusion system 210 can look
ahead a period of
15 time and generate the infusion schedule 704 - so long as the infusion
order 702 is active - for
infusion bag filling for that time period, or longer if specified on demand.
The ordering
clinician is not required to specify an end-date for the infusion order. The
infusion system 210
can include automatic scheduling of infusion bag delivery based on infusion
system 210 defined
tolerances 542.
20 Order Preparation
FIGURE 9 is a block diagram showing functional components for infusion order
preparation 506 of FIGURE 6. Infusion preparation 506 includes functional
blocks for
preparing infusion order 702 (FIGURE 8). Infusion preparation 506 can include,
but is not
limited to, detelinining preparation location 506a, scanning ingredients 506b,
bag duration
25 checking 506c, and bar code printing 506d for medication labels 124a.
Bar code printing 506d
can include the functions described above in reference to print label 326
(FIGURE 4).
After infusion orders are entered into the infusion system 210, preparation
instructions
are routed to a preparation location. The preparation location depends upon
the infusion
system's 210 preparation program 506 and the infusion components. The infusion
system 210
30 can include adjustable databases, such as preparation area database
546a, that specify where the
infusion order is to be prepared. The infusion order can be prepared in the
pharmacy or in a
remote location, such as on the floor or at the treatment location 106. The
clinician 116 is
guided through the preparation process, including bar code verification of
ingredients, using
event management information that can be displayed on digital assistant 118 or
another device

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having a display.
The medication label 124a identifies the ingredients and ingredient
concentrations. The
medication label 124a can be printed in any location. The medication label
124a preferably
includes bar code printing 506d. Bar code printing 506d can include printing a
bar code label
124a for each infusion bag. The label 124a assists in ensuring that the
correct medication is
administered at the correct times and/or in the correct sequence. Alternating
and sequencing
infusion orders are particularly vulnerable to sequencing and timing errors.
Bar code printing
506d can include printing a unique bar code label for every bag in infusion
order 702. Bar code
printing 506d can also include printing a bar code label 124a that uniquely
identifies the
combination of ingredients in an infusion bag and the concentration of those
ingredients. The
bar code for medication 124 can include a prefix, a suffix, and the national
drug code (NCD).
In an embodiment, the bar code can also include a lot and expiration date.
Alternatively, a
separate bar code can be provided to include the lot and expiration date.
Other embodiments of
the bar code, including active or passive RFID tags, magnetic strips, etc. can
be used.
Medication Administration
FIGURE 10 is a block diagram showing functional components for medication
administration 512 of FIGURE 6. Medication administration 512 includes
functional blocks
that are used to administer the medication to patient 112. Medication
administration 512 can
include reading a medication bar code 512a, reading a patient bar code 512b,
running an
expiration check 512c, providing titrate notification 512d, providing a flow
rate to drip rate
display 512e, providing "as needed" infusion initiation 512f, downloading
operating parameters
512g, and time monitoring 512h. The infusion system 210 can also translate
orders that may
have more than one flow rate, such as tapering and alternating orders, into
the flow rate for the
infusion bag currently being administered. The infusion system 210 can also
translate orders
having infusion bags with different ingredients, such as sequencing orders,
into the flow rate for
the infusion bag currently being administered.
Upon administering the medication 124, the clinician 116 scans the medication
label
124a. The infusion system 210 includes scanning the bar-coded label 124a when
initiating the
administration of the infusion order, when changing flow rates, changing bags,
and/or stopping
the infusion order. Infusion system 210 verifies that the infusion bag having
the bar-coded label
should be administered at that time and is for patient 112. The history of the
medication
administration, including flow rates and volumes administered, can be captured
and maintained.
Some infusion orders require hanging of an infusion bag with the intent of
only a partial,
specific amount of the infusion bag to be administered. The infusion system
210 allows a

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clinician 116 to order an amount of an infusion bag to be administered. Most
infusion pumps
have the ability to define the volume to be administered or the flow rate and
time period. Once
this time has elapsed, the infusion pump will automatically prevent further
administration.
Infusion system 210, as a reminder to the administering clinician, provides a
message on the
medication label 124a that it is to be partially administered and the
appropriate volume to be
administered.
Flow rate to drip rate display 512e uses data generated by flow rate to drip
rate
functions 548f to provide the administering clinician with drip rates for the
current infusion bag.
During medication administration 512, the clinician 116 can check on the flow
rate and other
operating parameters using the digital assistant 118. Flow rate modifications
1002b (FIGURE
11) are communicated in real-time.
The infusion system 210 can include PRN or "as needed" infusion initiation
512f. "As
needed" infusion initiation 512 causes the creation of a new active order and
the preparation of
the PRN medication. This option can include prompting the clinician 116 to
select a PRN
infusion from a list of anticipatory PRN orders placed for the patient and
defaulting the
requested infusion bags to one. The clinician 116 can have the authority to
modify the
requested quantity of infusion bags.
Downloading of operating parameters 512g can include determining whether the
patient
identifier associated with the medical treatment and/or the patient identifier
retrieved from the
wristband 112a, is the same as the patient identifier associated with the
medical treatment at the
central location. The determination often is made by the first computer, for
example, the first
central server 109. If the infusion system 210 determines the various patient
identifiers are not
the same, the system can generate an alarm message 520. If the infusion system
210 determines
the various patient identifiers are the same, the infusion system 210 can
download the operating
parameters directly to the medical device 332. The infusion system 210 can
send the operating
parameters to a medical device 332, such as infusion pump 120.
One benefit of the system program 210 is that the operating parameters for the
medical
device 332 do not have to pass through digital assistant 118, or any other
computer in the
remote location, prior to the operating parameters being available to program
the medical
device 332. Bypassing computers at the remote location eliminates a potential
source of errors
in administering medication 124 to a patient 112. The operating parameters for
the medical
device 332 can be sent "directly" to the medical device 332 assuming the
various verifications
are achieved. In this context, "directly" means that the operating parameters
can be sent to the
medical device without passing through the digital assistant 118, or any other
computer in the

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remote location.
In another embodiment, the infusion system 210 can include an additional block
(not
shown) where the central computer accepts a second medication identifier. The
clinician 116 at
the remote location can enter the second medication identifier. The second
medication
identifier can be a revised first medication identifier. For example, the
second medication
identifier can be part of the prescription or electronic physician order entry
that is the source for
the first patient ID and the operating parameters. The infusion system 210 can
then confirm the
first and second medication IDs are equivalent prior to sending the operating
parameters to the
medical device. The second medication ID can be replaced by a revised first
medication ID
between the time the prescription is entered and the time the medication 124
arrives at the
treatment location 106. The infusion system 210 will then sound an alarm if
the second
medication identifier is not equivalent to the first medication identifier
that was included in the
medication label 124a. In a further embodiment, the infusion system 210 can
include an
additional block (not shown) where the operating parameter is used to program
the medical
device 332.
Various blocks of the infusion system 210, such as block 512, can include
displaying
treatment information on the digital assistant 118. This can include
displaying information that
mirrors the information on display 120c of infusion pump 120. The information
on display
120c of infusion pump 120 can be supplemented with information about the
patient 112, the
patient location, and the infusion order. This information can include
information regarding
multiple channels of infusion pump 120. The displayed information can include
information
such as, but not limited to, personality, prompt line, status line, operating
icons and pump head
display. Operating icons include falling drop, stop sign, flow check
piggyback, and delay start.
The pump head display includes information such as the drug label and the
infusion rate. Those
having ordinary skill in the art are familiar with the displayed information
and operating icons
described above.
The infusion system 210 time monitoring 512h calculates the time remaining for
an
order to be completed and the volume of an infusion order that remains to be
administered.
When the clinician 116 uses the infusion system 210 to administer the infusion
order, to make
flow rate changes, and to check on the status of an infusion, the infusion
system 210 calculates
time and volume remaining to be administered and indicates if the calculation
indicates a partial
bag will be used. For example, on the last bag of an order that is to be
stopped before the full
volume is administered, and/or on a bag within an order that must be changed
before the full
volume is administered, the clinician 116 is alerted on digital assistant 118
and/or cart 132. The

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alert can include a message such as, "Please only administer 150 ml."
Time monitoring 512h includes tracking any modifications made to the flow rate
using
bar code scanning. The pharmacy is alerted in real time to adjust the
preparation 506 of the
next required infusion bag according to the modification. Monitoring of
preparation 506 and
medication administration 512 allows for a just-in-time delivery of medication
124. Just-in-
time delivery reduces wastage attributed to discontinued or changed infusion
orders.
Monitoring also ensures patient 112 safety.
For titrate PRN orders, the clinician 116 is automatically notified of
required flow rate
changes if the titration conditions in the order indicate that the flow rate
must be changed. The
infusion system 210 includes defined functions for calculating a conversion of
flow rates to drip
rates 548f. The infusion system 210 defined values can be adjustable. The
infusion system 210
can include automatic translation of flow rate to drip rate 548f to assist the
clinician 116 during
administration of the treatment.
Order Documentation and Modification
FIGURE 11 is a block diagram showing functional components for infusion order
documentation 1012, and the infusion order modifications 514 and messaging 520
of FIGURE
6. Modifications 514 include functional blocks used to modify existing
infusion orders.
Modification 514 can also be viewed as creating new orders to replace existing
infusion orders.
Modification 514 can include modification changes 1002, generally all ordering
options for new
orders 1004 are available, rechecks 1006, recheck overrides 1008, and new flow
rate to new
drip rate display 1010. Infusion order modifications often lead to
documentation 1012 and
messaging 520. Modifications 514 include the functions described in reference
to prescription
modification module 336 (FIGURE 4). However, modifications 514 are also
accessible from
other portions of the patient care system 100 such as, but not limited to,
prescription entry 324,
prescription activation 306, and prescription authorization 308.
Modifications 514 include modifying the duration 1002a, modifying the flow
rate
1002b, using a new infusion site 1002c, identifying reasons for modifications
1002d,
identifying the volume of an infusion bag 1002e, and processing stop orders
1002f. Clinicians
116 can also change an infusion rate without an order if the patient 112 is
complaining of
discomfort or to facilitate fluid balance, such as when the patient 112 is
vomiting.
Modification changes 1002 include identifying a new duration 1002a,
identifying a new
flow rate 1002b, identifying a new infusion site 1002c, identifying a reason
for a modification
1002d, identifying the volume remaining in the infusion bag 1002e, and stop
orders 516. The
ordering options available during initial infusion order creation 504 are
generally available for

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modifying the infusion order. Ordering options available during initial
infusion order creation
504 include those shown in FIGURE 8. Rechecks 1006 and recheck overrides 1008
are
analogous to checks 564 and overrides 566 that are described in reference to
FIGURE 8. New
flow rate to new flow rate display 1010 assists the clinician and minimizes
the possibility of
5 errors during medication administration 512. The modified infusion order
can lead to a
modified infusion schedule.
Flow rates are frequently modified at the treatment location 106 for reasons
such as to
catch-up without changing the schedule for preparation when the infusion has
been
inadvertently stopped for a short time period. Such modifications may not
require new infusion
10 schedule 704 to be communicated to the pharmacy. In other cases, the new
schedule 704
should be communicated to the pharmacy or other preparation staff. Flow rate
modifications
1002b trigger infusion order scheduling changes and/or messages 520 for
appropriate clinicians
116.
When a clinician 116 enters a flow rate modification 1002b into the infusion
system 210
15 at treatment location 106, the clinician 116 can also elect to have the
infusion schedule 704
recalculated and sent to the pharmacy. The clinician 116 has the option of
requesting new
medication labels 124a to be printed by bar code printing 506d module. The new
medication
labels 124a include data reflecting the new information for any of the
previously prepared
infusion bags.
20 The
infusion system 210 and/or the clinician 116 can request a modification to the
infusion site 1002c. The site can be selected from a list of anatomical
representations on a
computer screen. The
clinician 116 can be required to identify a reason for the
modification 1002d. Reasons stored in databases such as, but not limited to,
override reasons
for timing 546f and override reasons for flow rate 546g, can be displayed for
easy identification
25 by the clinician 116. There can be a separate hard-coded reason for
physician-ordered
modifications. For physician ordered modifications, the clinician 116 can be
requested to
identify the physician.
Prior to implementing the modification, the volume remaining in the current
infusion
bag is identified 1002e. The clinician 116 can be offered the option of
accepting a volume
30 calculated from a displayed value of pre-modification flow rate and/or
volume.
If desired, the current infusion can be stopped 1002f. If stopping the order
is not
required, for example the same infusion bag can be used with a new flow rate
and/or a new
medication added, the old flow rate can be identified and compared to the
modified flow rate.
Any infusion bags that were previously prepared can be checked for expiration
based on

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the new infusion schedule 704. When an infusion order is resumed following
either a
temporary stop or a hold order, the expiration check can be done regarding
expiration of
solutions that have already been prepared.
The new infusion schedule 704 is used to control the preparation 506 in the
pharmacy or
other preparation site. A system default 544 can be set for whether or not any
prepared bags
should be credited to the patient 112 through the billing interface 312, and
whether or not they
should be credited to inventory.
Infusion order changes 1002 include all ordering options available 1004 for
new orders.
The modified flow rate can be rechecked 1006 for rules and tolerances such as,
but not limited
to, net concentration 1006a, flow rate 1006b, administration time 1006c,
duration 1006e, and
infusion site 1006f. Overrides 1008 can be available for modifications that
are outside of
tolerances. The infusion system 210 can display reasons 1008f for overrides
and for
administering medications at times other than that specified in the original
order. The clinician
116 can be required to identify a reason for the modification.
The infusion system 210 can offer the clinician 116 a display indicating the
modified
drip rate associated with the modified flow rate 1012. The displayed
infounation can be
calculated by the flow rate to drip rate 548f defined function. The infusion
system 210 can also
be provided with descriptions of typical infusion tubing used within the
infusion system 210 for
use in calculating drip rates.
A modification results in the infusion system 210 validating the expiration of
the
infusion bag and providing a message to the clinician 116 if the infusion bag
expires prior to the
completion of the order. The message can request that the clinician 116
contact the phatutacy.
The validation of the expiration of the infusion bag for solutions such as,
but not limited to,
premixed solutions and solutions manufactured outside of the infusion system
210, may include
parsing the scan code.
Flow rate override 1008b can provide an indication of whether the clinician
116
modifying the infusion order has the authority to override the ordered limit
without requiring
approval for a new infusion order. This indication can apply to the patient
care system 100 or a
subsystem.
Documentation 1012 captures infusion order information in real-time.
Documentation
includes documenting multiple infusions being administered at the same time
and infusion
modifications such as, but not limited to, duration changes 1002a, flow rate
changes 1002b,
volume changes 1012c, and infusion site changes 1002d.
The infusion system 210 can assist the clinician 116 in capturing all changes
in flow rate

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as the changes are occurring. The clinician 116 can change the flow rate as
called for in the
order, such as to decrease a morphine infusion flow rate from 4 ml to 2 ml.
Though the infusion
system 210 may recognize the change as a new order, the infusion system 210
may be
configured to avoid duplication so that the modified order does not result in
the generation of a
new bag.
Documentation 1012 includes the ability to document changes such as, but not
limited
to, an infusion that is stopped temporarily, discontinued, and/or restarted.
The clinician 116
may stop infusion for a variety of reasons, such as the infusion site having
been compromised,
the infusion has been dislodged, and/or the infusion may be heparin/saline
locked to facilitate
the movement of patient 112. The infusion can be resumed when a new
site/infusion has been
reestablished. However the length of time this may take is variable and is
generally recorded by
the infusion system 210.
Government regulations often require tracking of every step in the process of
infusion
administration. Infusion system 210 allows the administering clinician 116 to
document flow
rate modifications on a digital assistant 118, or other computer device, by
scanning the
medication label 124a and adjusting the flow rate 1002a based on a tolerance,
such as a
tolerance created by set tolerance 542. A flow rate modification 1002b
corresponds in real time
with the associated pharmacy's infusion schedule 704 to ensure just-in-time
inventory
management of infusion bags to the patient treatment area 106. Documentation
1012 may allow
order backdating under some circumstances.
The infusion system 210 includes the ability to document the infusion site
1012d and
multiple infusions 1012e for multiple infusion sites. In many situations, a
patient 112 can have
multiple medications 124 and "y-ed" infusions so that the some infusions are
running into one
site and other infusions are infusing into another site. For example, morphine
infusion,
antibiotics and normal saline infused into the right arm (site 1) and TPN and
2/3 & 1/3 running
into a double lumen CVL (site 2). The infusion system 210 allows clinician 116
to document
which site the various fluids are infusing through. In treatment locations
106, such as intensive
care units, many more than two infusions may be running into one line or one
lumen.
Clinicians 116 are able to indicate which lumen of a CVL the infusion or
medication is running
into.
The infusion system 210 includes the ability to document the site location
1012d for
infusions and any site location changes. Infusion sites are frequently changed
due to occlusions
or policy. Therefore, clinicians 116 must document a change in the site
location if an infusion
becomes dislodged and was subsequently restarted.

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The infusion system provides for centralized device configuration.
Operating
parameters for medical devices, such as infusion pump 120, often include
defaults and/or
tolerances. The defaults and/or tolerances can reside in the infusion system
210, for example
flow rate tolerance 542b, and/or in a memory associated with the device 332.
For example,
infusion pumps 120 can include a database having a table of medications having
associated
flow rate tolerances. If the clinician 116 enters a flow rate that is beyond
the associated flow
rate tolerance, the clinician 116 is warned and then can be allowed to
proceed, or prohibited
from proceeding. Devices 332 such as heart rate monitors can also have
configurable tolerances
for alerts. In addition to alerts, many other characteristics can typically be
configured for
devices 332 such as: network name, IP address, polling frequency, and colors.
The infusion
system 210 includes configuring medical devices 332 individually or in groups
from one or
more central computers.
System configuration parameters can be defined for a first type of medical
device. The
system configuration parameters are sent and accepted by the first type of
device unless the
particular first type of device has more specific configuration parameters
that apply to that
particular first type of device. For example, a first plurality of a first
type medical device can be
located at general care treatment locations. A second plurality of the first
type of medical
device can be located at an intensive care treatment location, The general
care treatment
location may not have specific configuration parameters while the intensive
care treatment
location does have specific treatment parameters. System configuration
parameters will apply
to all of the first type of medical devices throughout the infusion system
210, i.e. the devices in
the general care treatment locations, unless specific configuration parameters
apply, e.g. the
intensive care treatment location.
For each type of device, specific configuration parameters that apply to all
devices of
that type across a particular grouping of the devices override the system
configuration
parameters if a particular device belongs to the group having such a
definition, unless the
specific configuration parameters are overridden at an even more specific
level within the
infusion system 210. The groups might be defined as a clinical service, a
nursing unit, and/or a
combination of service and nursing unit.
For each type of device, the user can define sets of configuration parameters
that apply
to all devices of that type being used for operations with specified ranges of
attributes that
override any other definition. In a hospital, the operations might consist of
infusion orders and
the attributes might include patient weight, drug, patient disease state, and
patient acuity.
Devices can be identified as part of a general group, a specific group, and/or
be

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associated with a particular patient by including the device address in a
table in a database.
General or specific configuration parameters can then be sent to the device
according to the
identification of the device. The specific configuration parameters can then
be read back to the
infusion system 210 and compared to the originally sent configuration
parameters to verify the
original configuration parameters were correctly received by the device 332.
If the
configuration parameters were not correctly received, the infusion system 210
can provide a
message 520 identifying the discrepancies or the communication failure.
The infusion system 210 can detect changes to configuration parameters made at
the
device, rather than through a central computer, and send a message and/or
alert 520. The
infusion system 210 can also poll the devices to verify their configuration
parameters. If system
and/or specific configuration parameters change, the changes can be propagated
to all devices
332 identified in the system as belonging to the group according to the
groupings identified in
the infusion system 210.
Throughout this document and the related claims, "central location" and
"remote
location" are relative terms to each other. A "remote location" is any
location where a patient is
receiving treatment through a controlled medical device, such as a patient
treatment location
106 where patient 112 is receiving treatment through an infusion pump 120.
"Central location"
is any location, other than the remote location, where parameters for
operating the medical
device are accessible such as, but not limited to, the location of the
pharmacy computer 104 and
the central system 108. In a typical arrangement, several remote locations,
such as treatment
location 106, are in communication with a central location.
While the present disclosure has focused on the use of infusion pumps 120
within the
system 210, it is understood that other medical devices may be used within the
system 210
without departing from the scope of the present invention. For example,
various types of
medical devices include, but are not limited to, infusion pumps, ventilators,
dialysis machines,
etc. An additional type of medical device is a micro-electromechanical system
(MEMS)
component. MEMS is a technology used to create tiny devices which can be less
than a
millimeter in size. MEMS elements are typically fabricated from glass wafers
or silicon, but the
technology has grown far beyond its origins in the semiconductor industry.
Each device is an
integrated micro-system on a chip that can incorporate moving mechanical parts
in addition to
optical, fluidic, electrical, chemical and biomedical elements. The resulting
MEMS components
are responsive to many types of input, including pressure, vibration,
chemical, light, and
acceleration. The MEMS components can be a number of different elements
including various
types of pumps, a flow valve, a flow sensor, tubing, a pressure sensor or
combinations of

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elements.
Accordingly, one use of a MEMS component is as an in-line MEMS pump 5314,
shown
schematically in FIGURE 53. The MEMS pump 5314 is capable of pumping fluid
contained in
the IV bag 5320 through the tube 5312, out through the access device 5324, and
into a patient.
5 The MEMS component has a MEMS local electronics element attached thereto,
and the MEMS
electronics element connects with an external, durable MEMS controller, which
can
communicate with the present system 210 as does the present infusion pump 120
described
herein. In one embodiment of a MEMS pump 5314, the MEMS electronics element
5332 is
embedded therein and can preferably store MEMS parametric operational
information. The
10 MEMS controller, with its electronics and power source, may be
physically or wirelessly
connected to the MEMS electronics element. In one embodiment, the parametric
operational
information may be loaded from the detachable MEMS controller 5338.
Preferably, the pump
element 5314 generates the fluid flow through a tube 5312 based on information
stored locally
within the MEMS electronics 5332. This information is preferably downloaded
from a wired
15 but detachable MEMS controller 5338. Further, the MEMS components may
communicate
with the system 210 via wireless communication. Additionally, the MEMS
controller may
provide a transfer of information to and from the system 210 to fully automate
the control and
interrogation of the MEMS components in the present system 210 through a
wireless or wired
communication path.
20 The use of MEMS or other emerging economical fabrication techniques
provides an
opportunity to add a MEMS element to a disposable line-set that provides
additional
functionality such as pumping, valving, and sensing. Some or all of the
supporting local
electronics could be included in a disposable portion of a line-set as well.
For example, it may
be preferable to include a memory chip that contains calibration information
for a pump,
25 pressure sensor and/or flow sensor, valve, or a combination of
disposable elements.
Disposability is desirable as it removes the need for costly sterilization of
the components of the
system between each subsequent application.
Pop-Up Windows
In an embodiment, the system can automatically provide clinicians with
information
30 associated with one or more medications via pop-up windows. Preferably,
a medication table is
entered into the central database 108b. The medication table can include the
generic name of
one or more medications, and any trade names associated therewith. Linked to
each medication
within the medication table are respective messages for display via pop-up
windows. The
messages can be defined by the health care facility, or predefined by the
system provider.

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Preferably, the messages associated with each medication pertain to: 1)
hazards associated with
the medication, such as in handling or exposure thereto; 2) how the medication
is to be
administered by a clinician; 3) physician reference information about
medication; 4) the
appropriate pump channel for infusing the drug; and, 5) warnings about
infusion set procedures
such as opening a roller clamp for a piggyback infusion.
The pop-up windows are displayed when a medication is selected or entered into
a
computing device such as: when the medication is being ordered by a physician
via the CPOE;
when the medication is being processed by the pharmacy or the like; and when
the medication
is being administered to a patient by a clinician. In an embodiment, when the
selection or entry
of a medication has been made on a computing device at a remote location, the
database within
the central system 108 is accessed wherein at least one of the pop-up window
messages
associated with the medication is provided to the remote computing device for
display to the
clinician.
Preferably, at least one of the pop-up window messages associated with a
medication is
provided for display upon the initiation of a specific step in the medication
order, process, and
administration procedure. For instance, upon entry of a medication order into
a computing
device such as the CPOE, a pop-up window is displayed with a message regarding
physician
reference information about the medication and, in an embodiment, another pop-
up window can
be displayed regarding hazards associated with the medication. Then, upon
processing of the
order by a pharmacy or the like, one or more pop-up windows are displayed on a
computing
device within the pharmacy 104 for providing general information about the
medication, and
possible hazards associated therewith. Next, when the order is being
administered by a
clinician, one or more pop-up windows are displayed on a computing device
associated with
the clinician (i.e., handheld 118) for providing information about
administration of the
medication, and, in an embodiment, possible hazards associated with the
medication such as
how the medication is to be handled.
Preferably, the pop-up windows displayed on a computing device are specific to
the step
in the medication order, process, and administration procedure that is being
carried out by a
clinician. For instance, the pop-up window containing physician reference
information is
preferably not displayed to the nurse, via handheld device 118. Nevertheless,
in an
embodiment, the user or hospital can define when, and if, a pop-up window
should be displayed
when a medication is selected or entered into a specific computing device.
It is also preferred that the pharmacy define when, and if, a pop-up window is
to be
displayed. For instance, pop-up windows are preferably not displayed for
common

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medications. Instead, pop-up windows are preferably displayed for medications
wherein the
pharmacy or healthcare facility believes that the additional information
within the pop-up
window will assist in the ordering, preparing, or administration of the
medication.
Administering A Medication
A method of administering a medication 124 with the infusion system 210 is
described
below. The method includes the ability to modify the infusion order. The
modifications
include modifications to the flow rate, the infusion site, temporary stops to
the infusion,
restarting the infusion, and hanging a new medication 124 container. The
method includes:
scanning a bar code associated with the patient 512b; scanning a bar code
associated with the
medication 512a; if the infusion is an admixture, validating the expiration
512c; selecting a
reason for the modification 1002d; and recording the remaining volume of the
infusion bag or
accepting the value calculated from the previous volume and flow rate 1002e.
The validation of
the expiration 512c of the infusion bag can include the use of an admixture
table and/or a bar
code.
The reason for the modification may come from a defined table 546g. The reason
for
the modification may also include a hard-coded value for physician-ordered
changes. When the
hard-coded value is selected, the clinician 116 is prompted to select the
physician from a list of
physicians. The attending physician can be the default in the list of
physicians.
There may be a quick select feature to halt the administration of the
medication 124, for
example, stop order 1002f. If the quick select is not chosen, the following
processes can be
included: recording the flow rate and/or accepting the previous value for the
flow rate - the
previous value is displayed on the digital assistant display 118a, the
infusion pump display
120c, and/or the medical cart 132; comparing the previous flow rate to the
ordered flow rate -
this comparison can be accomplished by using infusion system 210 or subsystem
rules and
tolerances; displaying appropriate messages; conversions between flow rates
and drip rates can
be displayed 1012 - the conversions can be calculated based on infusion system
210 defined
drip-rate conversion tables 548f. The infusion system 210 typically uses
descriptions based on
the tubing used to make it easy for the clinician 116 to select the correct
drip rate conversion.
Changing the flow rate triggers the infusion system 210 to validate the
expiration of the
infusion bag(s) based on scheduled flow rate. If the solution expires before
or during the
administration, a message is sent to the clinician 116, such as "This solution
will expire during
the scheduled administration period. Please contact the phal _____________
inacy." If it is a premixed infusion
bag and/or a customized infusion bag, the expiration is validated by parsing
the scan code, if
possible. The previous infusion site is accepted or a new infusion site
location is selected from

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a list or a graphical anatomical representation. Then the schedule 704 is
recalculated to
implement pharmacy restocking. Infusion system 210 can include biometrics for
identifying
patients and clinicians 116.
Prior to allowing a clinician 116 to access the infusion system 210, the
infusion system
210 accesses information related to the identity of the clinician 116. The
infusion system 210
can identify the clinician 116 by using a device, such as a bar code reader,
to read the clinicians'
badge 116a. The system can also use biometrics to positively identify the
clinician 116, to
assure the clinician is an authorized user of the system, and to determine
whether the clinician
116 has authority to access portions of the infusion system 210. The infusion
system 210 can
require a combination of the clinician badge 116a, or other key, and a
verified biometric match
in order to grant the clinician 116 access to the infusion system 210. The
system can also be
configured to terminate access to the infusion system 210 when the clinician
badge 116a is
removed from the vicinity of the device used to read the clinician badge 116a,
or other key.
Biometrics is the technology and science of statistically analyzing measured
biological
data. One field of biometrics is that of determining unique physical
characteristics, such as
fingerprints. Biometrics makes it possible to identify individuals to digital
systems, such as
infusion system 210. A digital persona is created that makes transactions and
interactions more
convenient and secure. Biometric features for identification include features
such as, but not
limited to, fingerprint, face, iris and retina scanning, and voice
identification. Biometric devices
include a scanning or reading device, software to convert the scanned
information into a digital
format, and a memory to store the biometric information for comparison with a
stored record.
Software identifies specific matched points of data that have been processed
with an algorithm
and compares the data. Unlike passwords, PIN codes, and smartcards, the
infusion system 210
biometrics cannot be lost, forgotten, or stolen.
The biometric scanner can be associated with the device for reading the
clinician's
badge 116a. For example, the biometric scanner can be a thumb print reader on
the handle of a
bar code reader. In other embodiments, the biometric scanner and an electronic
key reader can
be located on the portable medicine cart and/or the medical device. When the
clinician 116
places the electronic key within a specified distance of the medical device, a
processor will
know the specific individual electronic biometric identification file it
should expect. The
infusion system 210 preferably prompts the clinician 116 to scan his biometric
information.
The biometric infoithation is entered into the infusion system 210 with some
type of biometric
reading or scanning device. A one-to-one comparison is made between the
scanned biometric
information and the previously stored specific individual electronic biometric
identification file.

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This one-to-one identity comparison is more efficient than comparing one-to-
many identity files
because it does not require searching an entire clinician database for a
match. Instead, only one
specific comparison is made. If there is a match, then the clinician 116 is
granted access to the
medical device 332. If there is no match, the clinician 116 is denied access.
Additionally, in another embodiment, the medical device does not have a
controller.
For example, the medical device may be a pumping unit that does not have a
controller, but
rather merely accepts control signals from a separate controller. In one
embodiment, the
controller for such a medical device can be the first central computer 109.
Accordingly, the
first central computer 109 may send control signals directly to the medical
device for
controlling the medical device.
In another embodiment, after the infusion system 210 grants access to the
clinician 116,
the infusion system 210 terminates that access when the electronic key is
removed from the
biometric scanner, or the vicinity of the biometric scanner. The vicinity
within which the
electronic key must be kept can be predetermined and/or may be a variable and
programmable
infusion system 210 parameter.
In one embodiment, the infusion system 210 includes an encrypted digital
fingerprint
template, a clinician's name, a login name, and a password. One technology for
implementing
the clinician identifier includes "IBUTTON 400" technology from Dallas
Semiconductor
technology. The infusion system 210 can be activated when the clinician places
a finger on a
fingerprint scanner. If the infusion system 210 finds a match, the infusion
system 210 can
request the clinician 116 login to the infusion system 210. If the infusion
system 210 does not
find a biometric match, the system does not allow the clinician 116 to access
the infusion
system 210.
In another embodiment, the database storing biometric information can be kept
in the
central system 108, the pharmacy computer 104, and/or the treatment location
106. At the
treatment location 106, the database can be maintained in the portable cart
132, the digital
assistant 118, and/or the medical device 332. Such distributed databases allow
access to remote
devices even if the network 102 is unable to communicate between the various
locations. When
network 102 communication is reestablished, the remote and central databases
can be
synchronized with any information modified at the other location so that both
infusion system
210 databases are properly updated.
The infusion system 210 provides a closed loop infusion therapy management
system.
The closed loop begins with a clinician 116 order. Among other methods, the
clinician 116 can
enter the order through digital assistant 118 and/or medical treatment cart
132. The order is

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then available in real-time for pharmacy authorization 508 and physician
authorization 510.
The order is available in real-time as an electronic medication administration
record (eMAR).
The eMAR is available to the clinician 116 for infusion administration. The
infusion system
210 automatically documents medication administration 512 and modifications
514 such as
5 flow rate changes 1002b. Through the process of medication administration
512, the infusion
system 210 simultaneously adjusts infusion system 210 and/or subsystem
inventory and billing
518. The infusion system 210 also provides event management and decision
support data. The
infusion system 210 is device independent, meaning that it can be run on
workstations, wireless
tablets, and handheld digital assistants 118. The infusion system 210
generally runs in real
10 time, however, batch processing and or messaging can be used to
coordinate various stages of
the infusion system 210 processes.
The closed loop infusion therapy management system includes infusion order
entry 560,
order preparation 506, and the availability of the status of the infusion.
Infusion order entry 560
can be through a number of means such as, but not limited to, the prescription
entry module
15 324, the prescription modification module 336, and the pharmacy
interface 316. Computer
screen 400 can be employed in entering the infusion order. The status of the
infusion provides
patient 112 specific usage of infusions and alerts the pharmacy of the need
for additional
infusion bags.
Clinician Interaction With The Infusion System
20 Further, the infusion system 210 can use a login system to determine
if the clinician 116
has access to the infusion system 210. One example of an interface screen of a
login system for
an infusion system 210 is shown in the login screen 1903 of FIGURE 19. In that
interface
screen, the clinician 116 enters both a user name and a password, and clicks
on the "Login" key.
The system 210 conducts a check to confirm that the user name and password are
valid for the
25 system 210. If either the user name or the password is not valid, the
system 210 will inform the
clinician 116 that the login failed in the login screen 2005 shown at FIGURE
20. The clinician
116 will then have the opportunity to reenter the user name and password to
correct any errors.
If the user name and password are valid, the clinician 116 will have access to
the system 210.
Additionally, if the clinician 116 is logged in to a digital assistant 118,
but does not use it for a
30 period of time, a security feature of the system 210 prevents the
digital assistant 118 from being
used further until the clinician 116 logs back in.
The charge clinician may also login to the system 210. As explained in detail
herein,
the charge clinician is generally a supervisor or some person whom the
clinicians report to.
Additionally, the charge clinician may be a person who assists in workflow for
the clinicians, or

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who assists in monitoring alarm or alert conditions. Typically, the charge
clinician maintains a
supervisory or responsibility role over at least one unit. Thus, the charge
clinician must login,
with a login and password as explained above, and then select the units to be
associated with the
charge clinician.
After the clinician 116 has completed the login process shown in FIGURE 19,
and has
been granted access to the system 210, the clinician 116 may perfoini several
administrative
functions. One such administrative function is to select a unit. As shown in
the unit selection
interface screen 2105 of FIGURE 21, the clinician 16 may select a unit from a
drop down menu
2107. In the example illustrated in FIGURE 21, the clinician has selected
"Neurology ICU" as
the unit. After the clinician 116 has selected the appropriate unit from the
drop down menu
2107, the clinician 116 can depress the arrow key 4809 to enter the selected
unit.
Another administrative function that the clinician may execute is to select
the clinician's
shift. As shown in select shift screen interface 2211 of FIGURE 22, the
clinician 116 may
select either a standard shift or a customized shift. Several standard shifts
which may be
selected are provided in the drop down menu 2107 for that entry. If, however,
the clinician 116
selects the customized shift, the clinician is requested to enter the start
time and the end time for
the customized shift. The clinician 116 may also enter a manual shift in the
provided area 2255
and then tap the enter key 4809.
A view patient interface screen 2313 is shown in FIGURE 23. In that screen
2313, after
the shift has been selected, the clinician 116 may view the patients
associated with the clinician
116. The clinician 116 may also view the tasks associated with the clinician
116. Accordingly,
a "to-do" list may be provided based on the patients, the clinician's tasks or
both. Different
levels of shading and/or coloring may be utilized to differentiate between the
level of urgent
care required for a specific patient. Additionally, various icons may be used
in connection with
the patients to provide the clinician 116 a quick understanding of the care
required by a patient.
The patient view interface screen 2313 of FIGURE 23 also provides the
clinician 116 with the
ability to add more patients at button 2315. When the clinician 116 selects
the "Add More
Patients" key 2315, the clinician may be provided with a list of additional
patients.
The clinician 116 may also be provided with a patient selection interface
screen 2417 as
shown in FIGURE 24. At this screen 2417, the clinician 116 may select patients
to be added to
the clinician's shift. The patients may be from the unit associated with the
clinician, or the
clinician may select to add patients from different units. The clinician 116
may also select the
amount of time with which they will be associated with that patient. Further,
the clinician 116
may also find more patients at key 2419. It is also understood that the
clinician 116 may also

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remove patients from a shift at any time.
The system 210 also provides messages to the clinicians 116 that are specific
to the
patients assigned to the clinician's shift. Typical messages may include items
such as order
profile changes and missed medication administrations.
A patient information menu interface screen 2521, shown in FIGURE 25, is also
available on the present system. The patient information menu screen 2521
provides a mini
patient chart for the selected patient. The patient menu screen 2521 also
provides the clinician
116 the ability to link to items relating to the patient, such as: administer
medications/infusions,
stop infusion, resume infusion, titrate infusion, flow rate history, pump
status, and remove
patient from shift. The patient menu screen 2521 also has tabs for: Allergies
and Ht/Wt,
Medication History, and Lab Results. An example of an Allergies & Ht/Wt
interface screen
2521a is provided in FIGURE 25a. Typically this screen 2521a is displayed when
the mini-
chart is first opened. It displays infounation about the patient's drug and
general allergies, and
the last recorded height and weight of the patient. An example of a Medication
History
interface screen 2521b is provided in FIGURE 25b. Typically, this screen 2521b
provides the
clinician with a medication history of the patient within the selected look
back period. The look
back period may be adjusted by the clinician. Finally, an example of the lab
results interface
screen 2521c is provided in FIGURE 25c. Lab results are made available in the
system 210
through a lab interface. All available results are shown, and displayed in
reverse chronological
order.
An infusion schedule interface screen 2623 for a patient is shown in FIGURE
26. This
screen 2623 illustrates an infusion schedule for the selected patient. By
clicking one of the
identified orders, such as order 2625 for Morphine Sulfate on the infusion
schedule screen
2623, the system 210 will link to the medication order interface screen 2627
shown in FIGURE
26a. Medication order screen 2627 provides a detail of order 2625 for the
specified order (i.e.,
Morphine Sulfate). As part of the detailed order 2625, the therapy parameters
2629 are
provided, as well as any warnings 2631 and the ability to link to additional
information 2633.
FIGURE 28 illustrates a patient profile infusion schedule interface screen
2835 wherein
one of the scheduled infusions was missed. As shown in screen 2835, a "missed
medication"
icon 4837 is shown next to the schedule Morphine Sulfate infusion order 2839.
By clicking on
the "missed medication" icon 4837, the system 210 links the clinician 116 to a
missed
medication interface screen 2941 as shown in FIGURE 29. The missed medication
screen 2941
requests the clinician 116 to enter, or select in the drop down menu, a reason
2943 for missing
the medication. The missed medication interface screen 2941 also inquires of
the clinician 116

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whether the medication schedule for the order 2839 should be adjusted. To
adjust the
medication schedule, the clinician 116 would select box 2945 on interface
screen 2941. When
the clinician 116 clicks on the drop down menu to enter select a reason 2943
for missing the
medication, the drop down menu will expand as shown on interface screen 3047
of FIGURE 30.
Typically, if the medication is no longer needed, the clinician will select
the "Not Required"
reason 3045. When the clinician 116 selects the "Not Required" reason 3045 for
missing the
medication, the system 210 removes the missed medication icon 4837 and inserts
the "Not
Required" icon 4857 as shown in the infusion schedule screen 3135 of FIGURE
31.
When the clinician 116 is ready to provide a medication therapy or order for a
patient,
the clinician 116 will select the order 3225 in the schedule interface screen
3235, and then scroll
down to the "Get Items" key 3249 as shown in FIGURE 32. After the clinician
116 selects the
"Get Items" key 3249, in screen 3249 of FIGURE 32, the system 210 displays a
medication
interface screen 3351 as shown in FIGURE 33. In the medication screen 3351,
the clinician
116 has the ability to scan the medication selected from the medication depot
as shown at the
"Scan Depot" icon 3353, or to skip the scan depot block by selecting the "Skip
Scan Depot" key
3355. When the clinician 116 scans an item, such as by scanning a bar code on
the item, the
item infoimation is displayed on the clinician's PDA 118. An example of a scan
screen 3465 is
shown in FIGURE 34. When, for example, the clinician 116 scans a medication,
the
prescription 3467 is displayed in the scan screen 3465. If, however, the
scanned item does not
match the order for the patient, a scan error screen 3569, such as shown in
FIGURE 35 will be
displayed on the clinician's PDA 118. As shown on interface screen 3569, when
a scanning
error is detected the clinician 116 will be provided with an identification of
the item to request
or search for as shown on screen 3569. If a bar code cannot be scanned, for
example due to a
smeared or damaged bar code label, the data requested by the scan can be
entered manually.
If the selected medication is in the same therapeutic class as another
medication that
was recently administered to the patient, the clinician's digital assistant
118 displays a warning
message. Similarly, if the item has already been retrieved by another
clinician, the digital
assistant 118 displays a message indicating such occurrence.
If the order to be retrieved is a mix-on-floor infusion, the individual
ingredients are
identified on the digital assistant 118 and are to be retrieved by the
clinician 116. After the
items are retrieved, the system 210 generates a bag ID and prompts the
clinician 116 to print a
label 124a. At this point the clinician 116 also mixes the ingredients. After
the clinician 116
prints out the label, the label is added to the bag and it can be scanned by
the digital assistant
118.

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Certain orders may be either on-call or on-hold. These orders are displayed on
the
patient profile screen, such as interface screen 2835 of FIGURE 28. Orders
that are either on-
call or on-hold are available for viewing only, and not for retrieval. These
orders are
subsequently activated as appropriate.
The scenario may also arise where the clinician 116 has an item, including a
medication
item, that is not being used for a patient. Referring to interface screen 3657
in FIGURE 36, the
clinician 116 has the ability to identify the reason for not administering a
medication, such as:
not being required due to a monitoring result, the patient being unavailable,
or the medication
being refused. If the patient is not already identified in the screen 3657,
the clinician 116 can
select 3661 the patient by scanning the patient or entering the patient's
name. Additionally, the
clinician 116 can select to return the medical item to the medication depot by
keying the
"Waste/Return" selection key 3663. For certain narcotics and controlled
medications, two
signatures (i.e., a second authorization signature typically in the form of a
login and password)
may be required both to initially obtain the medication, and to return the
medication to the
depot.
The interface screen 3657 of FIGURE 36 also provides the clinician 116 with
the ability
to scan the patient ID to identify the patient. If the wrong patient is
scanned, or if the patient ID
does not scan properly, the system 210 displays a message that the scan is
invalid. Further, if
the clinician 116 is unable to administer the medication, the clinician will
typically have to enter
a reason 3659 for not administering the medication as shown in screen 3657 of
FIGURE 36.
Some reasons for not administering the medication are: the medication is not
required due to a
monitoring result, the patient is unavailable, or the medication is refused by
the patient.
After the clinician 116 has already verified the patient and the item or
medication, a
route verification interface screen 3771 is displayed. As shown in FIGURE 37,
one example of
a route verification screen 3771 assists the clinician 116 in verifying the
route 3773, line 3775
and site 3777. The medication therapy 3778 may also be provided in the route
verification
screen 3771. After the clinician enters the route 3773, line 3775 and site
3777, the clinician 116
can select the compare button 4817 and the system 210 will verify that the
entered data is
correct.
Next, the clinician 116 can select the pump channel mode as shown in the
interface
screen 3881 of FIGURE 38. In the pump channel mode interface screen 3881, the
therapy
3882 is shown and the clinician 116 has the option to designate the therapy
3882 as a primary
therapy 3884 or a piggyback therapy 3883. Each channel of the pump has the
ability to operate
a primary therapy in addition to a piggyback therapy. After the pump channel
mode has been

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selected, the clinician can conduct a pump channel scan. FIGURE 38a
illustrates a pump
channel scan interface screen 3885. In the pump scan screen 3885, the
clinician 116 scans the
medical device, such as by scanning a bar code corresponding to the pump
channel 121 and
then clicking on the arrow key 4809.
5 After the clinician 116 has: (a) scanned the patient, such as on
interface screen 2313 of
FIGURE 23, (b) scanned the medication, such as on interface screen 3465 of
FIGURE 34, and
(c) scanned the pump channel, such as on interface screen 3885 of FIGURE 38a,
the clinician
116 can program the infusion pump and conduct a comparison of the programmed
infusion
pump parameters or settings to the parameters of the pharmacy order.
10 Comparison of Device Settings and Orders
A exemplar flowchart of a comparison process 5200 is provided in FIGURE 52.
This
process may also apply to programming the infusion settings remotely from the
server.
Referring to FIGURE 52, the comparison process 5200 is initiated at block 5202
after the
clinician 116 has scanned the patient ID 112a, medication container or bag ID
124a, and the
15 pump channel 121, as identified above. By scanning the patient,
medication bag and pump
channel, an association of the relevant baseline data is provided such that
the system 210, and
more specifically server 109, can conduct further analysis and comparison of
this and additional
data. First, however, the first central server 109 conducts a check at block
5204 to ensure that
the scanned or entered data for the patient, medication bag and pump channel
results in a valid
20 association. If the three data items do not result in a valid
association, the system 210 displays
an error message at block 5206 and requests that the clinician 116 re-scan or
re-enter the codes
for each of the patient ID, bag ID and pump channel ID at block 5202. If the
three data items
result in a valid association at block 5204, the server 109 will also conduct
a sequence, as
explained below, to determine if the identified pump channel 121 is in the
server's 109
25 database, and if it is available for use.
After the pump channel ID has been scanned into the system 210, the first
central server
109 conducts a check at block 5208 to determine if the selected pump channel
121 is valid.
Various reasons for an invalid pump channel determination is that: the pump
channel does not
exist in the system, the selected pump channel is already in operation, etc.
If the check of the
30 pump channel 121 results in an invalid result, an error message is
displayed and the clinician is
alerted that an invalid channel has been selected. Until the clinician 116
rescans the pump
channel and a valid channel is recognized at block 5208, the comparison
process 5200 is
precluded and the system cannot conduct the comparison as identified in block
5214. If,
however, the check results confirm that the selected channel 121 is a valid
channel, the system

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progresses to block 5212 to establish the appropriate links, as explained
below.
At some time during the comparison process 5200, the second central server
108a
creates an XML message containing data relating to the patient ID and order
ID. As shown in
the flowchart for the comparison process 5200, the XML data may be created and
transferred to
the first central server 109, as identified at block 5210, at any point prior
to block 5212. If
however, the XML data received by the first central server 109 from the second
central server
108a is invalid or incomplete, the comparison process is precluded and the
system does not
allow the comparison process to proceed as shown in block 5214. Conversely, if
the XML data
relating to the patient ID and order ID is complete and valid, after the first
central server 109
receives the XML data from the second central server 108a, the comparison
process 5200
progresses to block 5212.
At block 5212 the first central server 109 attempts to establish a link or
association
between the patient 1D, the order ID and the pump channel 121. If the first
central server 109 is
not able to establish a link between the identified data at block 5212, the
comparison process
5200 is precluded and the system 210 does not allow the process to proceed as
shown in block
5214. Further, the system 210 displays an error message that some data is
missing or
inaccurate, and the system cannot conduct a comparison. If the first central
server 109 properly
establishes a link between the identified data at block 5212, the system 210
proceeds to block
5216 wherein the clinician 116 is requested to press the compare button 4817
on the digital
assistant 118. An example of the sequence of screens occurring at block 5216
is identified
below.
After the appropriate links have been established by the first central
computer 109, the
system 210 progresses to one of the comparison interface screens, such as
comparison interface
screen 3986 of FIGURE 39. In this comparison interface screen 3986, the system
210 provides
instructions to the clinician 116 to program the infusion pump prior to
conducting any
comparisons. Comparison may be made to ensure that the pharmacy parameters for
the
medication and the pump settings are in agreement. In a preferred embodiment,
in the
comparison process 5200 as identified herein, the system 210 conducts a rate
comparison. The
system may, however, conduct a single comparison or simultaneous multiple
comparisons of
any infusion parameter such as rate, volume, dose, etc.
If the infusion is a primary infusion, the instructions are provided to click
the
"Compare" button 4817 on the comparison interface screen 3986 and then to wait
for
instructions prior to starting the pump channel. If the infusion is a
piggyback infusion, the
instructions are provided to press the start key on the pump 120 and then to
click the "Compare"

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button 4817. In a piggyback infusion, if the clinician 116 presses the compare
button 4817 at
block 5216 prior to pressing the start key on the pump, the interface screen
4287 as shown in
FIGURE 42 will typically be displayed providing the clinician with error
instructions.
Initially, prior to conducting a comparison the system 210 polls the server
109 to ensure
that the communication link between the pump 120, server 109 and digital
assistant 118 is still
active. If the communication link is active the comparison process 5200
proceeds. If the
communication link is lost, the comparison process is not able to proceed.
Accordingly, after the clinician 116 has pressed the compare button 4817, the
system
210 proceeds to block 5218 as shown in FIGURE 52. At block 5218 the system 210
determines
if the channel 121 is ready. For example, if the infusion has been identified
as a primary
infusion but the channel is already running, the system will default to block
5214 and display an
error message that the system cannot conduct a comparison. Further, if the
infusion has been
identified as a piggyback infusion, and the start key on the pump has not been
pressed, the
system will default to interface screen 4287 of FIGURE 42 to inform the
clinician 116 to press
the start key on the pump before pressing the compare button 4817.
The comparison process 5200 also checks the pump 120 to determine if the
settings or
operational parameters programmed into the pump 120 contains fresh data at
block 5220. As an
example, the system may require that the pump data have been programmed into
the pump
within a certain time limit (i.e., 5 minutes) prior to requesting the
comparison. Such a time
limit for determining if the data is fresh data can be set by the healthcare
facility. If the data is
not fresh data, the system will revert to block 5214 and display an error
message that the data is
stale. The system 210 will then request that the pump 120 be reprogrammed for
the comparison
process can proceed. If the data is detennined to be fresh data at block 5220,
the system 210
will execute the comparison at block 5222. The actual comparison of data is
generally
conducted at the first central server 109. As previously explained, the
comparison is to
deten-nine if the parameters programmed into the pump conform with the
physician's order.
Additionally, or alternatively, the pump settings can be remotely programmed
by the remote
controller or server.
After the comparison is conducted at block 5222, the system 210 determines if
there is a
match or mismatch at block 5224 and returns the results to the clinician 116
via the digital
assistant.
An example of a resultant comparison interface screen 3987 where the
comparison
results in a match is shown in FIGURE 39a, and identified at block 5226 in
FIGURE 52. In this
instance, if the pharmacy prescription parameters and the programmed pump
channel settings

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match, the clinician 116 is instructed to start the infusion pump 120.
An example of a resultant comparison interface screen where the comparison of
the
pharmacy prescription parameters and the programmed pump settings do not match
at block
5224, is depicted in the mismatch comparison interface screen 4087 of FIGURE
40 with the
mismatch icon 4825 shown. If this result occurs the system 210 will require
the clinician 116 to
either accept the mismatch, as identified at block 5228, or reprogram the
infusion pump at block
5230 and conduct another comparison at block 5216. Typically, the parameters
wherein the
mismatch occurred will be displayed in the mismatch screen 4087. If the
mismatch is accepted,
it will be recorded in the system database 109 at block 5232. Further, if a
mismatch is accepted
at block 5228, the server 108a will navigate the clinician to the appropriate
screen.
FIGURE 41 displays an example of a comparison interface screen 4187 whereby
the
system 210 is not able to conduct a comparison because some of the data is not
available.
Specifically, in the example of FIGURE 41, the pump rate settings have not
been entered into
the system 210. Thus, the system 210 cannot conduct the comparison until
additional data, such
as the rate in this example, has been entered. Typically, the system 210 is
not able to conduct a
comparison if: an infusion is already running, the system cannot receive
updated pump
information, there is a system communication error, or there is missing data
either from the
programmed channel information or the pharmacy prescription information.
Finally, the
comparison screen 4287 of FIGURE 42 displays another scenario whereby the
system 210
cannot conduct the comparison until further steps are taken as indicated.
Typically, this
interface screen 4287 is provided when the infusion is a piggyback infusion,
and the clinician
has pressed the compare button 4817 in interface screen 3986 of FIGURE 39,
instead of
pressing the start key on the infusion pump 120 prior to pressing the compare
button 4817, as
indicated in the instructions of interface screen 3986 of FIGURE 39.
After the infusion pump has initiated a therapy, the clinician 116 is able to
view on
his/her digital assistant 118 the status of the pump in a pump status
interface screen 4391 as
shown in FIGURE 43. The pump status display 4391 displays a list of all
currently active
infusions for a given patient. Typically, one of five icons will be displayed
in conjunction with
an infusion in this screen: infusion running indicator 4807, infusion standby
indicator 4809,
infusion stopped indicator 4811, an unknown icon, and a delay icon. The pump
status display
591 does not update in real-time while a current screen is being displayed;
however, by tapping
the refresh button 4819, the most current real-time pump status screen will be
displayed.
As shown in FIGURE 44, the clinician 116 is also able to view a flow rate
history
interface screen 4493. The clinician 116 can navigate directly to the flow
rate history screen

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4493 by clicking on the flow rate history link on the patient menu interface
screen 2521 shown
in FIGURE 25. The flow rate history shows the history of programmed flow rate
history
changes for a current infusion on a given channel. Generally, the patient
information associated
with the channel is displayed, as well as the current prescription information
for that channel.
Further, after the clinician 116 has logged in on the digital device 118,
selected the shift and
selected the patients, the clinician 116 can perform a variety of tasks on the
digital device 118,
including but not limited to: recording an administered infusion, recording a
stopped or resumed
infusion, recording a discontinued infusion, viewing pump flow rate history as
described above,
viewing pump infusion status as described above, responding to pump alarms and
alerts as
described below, viewing messages/notifications and responding to
messages/notifications.
Specifically, with respect to recording an administered infusion, after the
clinician 116 has
scanned the item bar code, the patient bar cock, and the pump channel bar
code, the clinician is
able to compare the programmed pump settings to the pharmacy-entered order as
explained in
detail above. Typically, the clinician 116 will then administer the infusion
using the pump 120
and record the infusion using the digital device 118.
To start an infusion, the clinician 116 typically scans the patient's
wristband bar code
112a and scans the infusion bag bar code label 124a. When prompted by the
digital device 118,
the clinician 116 enters and compares the line, site and route for the
infusion as shown in
interface screen 3771 of FIGURE 37. Next, in screen 3881 of FIGURE 38, the
clinician 116
selects a primary or piggyback infusion 3883, and scans the pump channel. The
clinician 116
then programs the pumps as directed by the physician order. When the pump 120
is
programmed, the clinician 116 selects to conduct a pharmacy order and pump
comparison
check, as shown in FIGURES 39-42. If the programmed pump settings match the
pharmacy-
entered order, an interface screen such as screen 4287 will indicate a match,
and the clinician
116 can tap the OK button 4805 to accept the match. Finally, the clinician 116
will press the
start key on the pump 120. The digital assistant 118 will then display the
record administration
results interface screen 4937 in FIGURE 49, and the clinician 116 can enter
the appropriate
result from the choices in the drop-down list. These steps can be repeated for
additional
patients and/or additional pumps or channels.
Before administering a medication, the clinician 116 may be prompted to enter
a
monitoring parameter, e.g., a heart rate before administering dioxin, or a
pain assessment before
administering morphine. When a monitoring parameter is associated with a
medication, each
administration of the medication displayed on the digital assistant 118 has a
link to an interface
screen where the clinician 116 may enter a value. An example of such an order
having a link

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5001 to the entry of a monitoring parameter is shown in the order displayed in
FIGURE 50.
After the monitoring parameter link 5001 is selected, a monitoring parameter
entry interface
screen 5003, as shown in FIGURE 50a is displayed. There, the clinician 116 may
enter into the
system 210 the requested information.
5
Additionally, the system 210 may request the clinician 116 to monitor a cycle
count,
typically when retrieving narcotic or controlled medications from the
medication depot. As an
example, when the depot drawer opens to provide the narcotic or controlled
medication, the
digital assistant 118 may display a cycle count interface screen 5101 as shown
in FIGURE 51.
This interface screen 5101 prompts the clinician to count the units of
medication currently in the
10 bin or
storage area, and then to enter this data in the field provided. The system
210 then
compares this quantity to the expected count. If the cycle count does not
match, the digital
assistant 118 displays a message indicating the mismatch, and then displays
the cycle count
screen 5101 again. If the cycle count does not match again, the system 210
will record the
discrepancy and appropriate measures may be taken.
15 As
circumstances require, a clinician may stop a running infusion before it has
finished.
This may be done either with or without a discontinue order in the system to
stop the infusion.
Infusions that have been stopped may be resumed as circumstances require, such
as titrating an
order. When the discontinued infusion 4813 and running infusion icons 4807 are
both
displayed on the digital assistant 118, the clinician 116 is instructed to
navigate on the digital
20
assistant 118 to display a list of all running infusions for the patient. An
example of such a
discontinue infusion interface screen 2727a is provided in FIGURE 27a. In
FIGURE 27a the
discontinued infusion order will be highlighted and indicated as being a
discontinued infusion
order. The clinician 116 will then scan the bar code on the solution container
for the
discontinued infusion, and then scan the patient's ID. Next, interface screen
2727b is provided
25 on the
clinician's digital assistant 118 as shown in FIGURE 2727b. In interface
screen 2727b
the clinician can enter the time the infusion has been stopped, as well as the
reason for stopping
the infusion. The clinician 116 can then physically stop the infusion pump 120
by depressing
the stop button on the infusion pump 120.
A resume infusion interface screen 2727c is provided in FIGURE 27c. Infusions
that
30 are
recorded as stopped, without an order to discontinue, may be resumed. To
resume an
infusion the clinician 116 must initially navigate to the appropriate
interface screen on the
digital assistant 118. By tapping on the stopped infusion icon 4811 in the
patient menu, a list of
all infusions currently stopped for the patient will be displayed as shown in
interface screen
2727c of FIGURE 27c. A prompt is provided for the clinician to select the
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resumed. The clinician 116 then scans the bar code on the solution container
for the infusion to
be resumed. The system 210 compares the scanned ID to those for the infusions
currently
stopped for the patient. After the system 210 compares the ID with those that
are currently
stopped for the patient, the digital assistant 118 prompts the clinician 116
to scan the patient's
ID. The system 210 then confirms that the scanned ID matches the patient's ID,
and the system
210 will display on the digital assistant 118 the description of the scanned
infusion and prompt
the clinician 116 to select a facility-defined reason for resuming the
infusion, as shown in
interface 2727d of FIGURE 27d. Once the reason is selected, the clinician 116
can restart the
infusion at the pump 120 and then tap the arrow 4809 to continue. The system
210 records the
infusion as having been resumed.
As shown in the various screen shots/interfaces for the digital assistant 118,
a variety of
icons are utilized to assist the clinician 116. Many of these icons are shown
in FIGURE 48.
The patient list button 4801 is a key that, when tapped, allows the clinician
116 to navigate
directly to the patient list screen, such as the patient list screen 2313
shown in FIGURE 23. The
back button 4803 is a key that, when tapped, returns the screen on the digital
assistant 118 to the
previous screen. The OK button 4805 is tapped to acknowledge data shown on the
digital
device 118. When the OK button 4805 is tapped the next screen is usually
displayed. The
infusion running indicator button 4807 indicates that a programmed infusion is
now running for
the selected pump 120 and channel. The infusion standby indicator 4809
indicates that a
programmed infusion has been put on standby for the selected patient, pump 120
and channel.
The infusion stopped indicator 4811 indicates that the programmed infusion has
been stopped
for the selected patient, pump 120 and channel. The infusion discontinue order
indicator 4813
indicates that a pharmacy-entered order will discontinue an infusion for the
selected patient,
pump 120 and channel. The physician's notes indicator 4815 indicates the
presence of
physician's notes for the selected patient, pump 120 and channel. The
clinician 116 can tap the
notes indicator 4815 to view the notes. The compare button 4817 is provided in
various
screens, and when tapped has the system 210 perform a comparison of the
scanned item with
the pharmacy-entered order, as well as additional comparisons. The refresh
button 4819 is
tapped to update and show the latest data on the screen. The exit button 4821
allows the
clinician to exit the current screen, and return to the previously displayed
screen. The enter
button 4809 is also the OK button and is tapped to acknowledge and enter
either data selected
from choices within a drop-down list, or data manually entered in a field. The
comparison
match indicator 4823 indicates that programmed pump settings match pharmacy-
entered order
information. The comparison mismatch indicator 4825 indicates that programmed
pump

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settings do not match pharmacy-entered order information. The cannot compare
indicator 4827
indicates that the system cannot compare the programmed pump settings to the
pharmacy-
entered order information. The pump alarm/alert indicator 4872 indicates that
an alarm or alert
condition is occurring. When the alarm/alert indicator 4872 is tapped, an
expanded pump alarm
and alert screen is displayed. On the alarm and alert screen, a red
alarm/alert icon 4872
indicates an alarm condition, and a yellow alarm/alert icon 4872 indicates an
alert condition.
The alarm/alert silence button 3074 is tapped to temporarily silence the
audible alert on the
digital device 118. The loss of communication indicator 4833 indicates that
the pump 120
and/or the hub 107 is not properly communicating with the system 210. A
message
accompanying this indication describes the steps to take to resolve the
problem. The wireless
module low battery alert indicator 4835 indicates that the hub 107 is
presently running on a
backup battery that has less than 30 minutes of battery power remaining.
The above disclosure relating to the setup and use of the digital assistant
118 has been
discussed with respect to a clinician 116 performing these functions. It is
understood, however,
that these tasks may be performed by any hospital administrative or staff
individual, whether or
not that individual is a clinician 116.
Emergency Notification Process
Referring to FIGURE 12, there is shown a preferred embodiment of an emergency
notification system 1200. A notifying party 1210 is in communication with a
communication
network 1220. One of skill in the art will appreciate the variety of
communication networks are
operable including, but not limited to, an Ethernet network, a coaxial cable
network, a wireless
local area network, and a wireless wide area network. Additionally, a variety
of communication
network protocols are operable, but not limited to, Transfer Control Protocol
/ Internet Protocol
("TCP/IP"), Wireless Application Protocol ("WAP"), and User Datagram Protocol
("UDP").
Additionally, the communication network 1220 is operable as a part of a larger
communication
network; for example, the communication network 1220 may be a wireless
communication
network in communication with a wired communication network existing in, for
example, a
hospital.
In communication with the communication network 1220 is a notifying party
1210. The
notifying party 1210 may be a hospital clinician, for example, a nurse,
doctor, hospital
administrator, or security officer. The notifying party 1210 may also be a
patient. Additionally,
the notifying party 1210 may be an automated process, for example, a computer
program or a
medical device. The automated process acting as a notifying party 1210 may be
programmed to
broadcast an emergency notification across the communication network 1220 upon
the

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fulfillment of a certain condition or an event. For example, the automated
process may be
programmed to broadcast an emergency notification upon the sensing of a
patient condition.
The emergency notification is received by one or more target parties 1230.
Target
parties 1230 may be clinicians, for example, doctors and nurses. The target
parties 1230 may
also be an emergency response officer or security officer, or an environmental
hazard team.
The target party 1230 may be any individual in communication with the
communication
network 1220. The present embodiment provides the notifying party 1210 with
the option of
sending the emergency notification only to a certain target party 1230 or
target parties 1230, or
to all target parties 1230; the embodiment allows for the notifying party 1210
to choose which
target parties 1230 receive the emergency notification.
The target parties 1230 and notifying party 1210 are in communication with the

communication network 1220. One skilled in the art will appreciate the variety
of modes of
communication 1240 which may provide for the notifying party 1210 and target
parties 1230 to
be in communication with the communication network 1220. For example, the mode
of
communication 1240 may be a wired connection, for example, a personal computer
or
programmable controller. The mode of communication 1240 may also be a wireless
network
connection enabled through a handheld computer or a cellular phone.
Referring now to FIGURE 13, there is shown a notification interface 1300 from
the
perspective of the notifying party 1210. One skilled in the art will
appreciate the variety of
interfaces which will enable the notifying party 1210 to broadcast an
emergency notification via
the communication network 1220. The notification interface may be a website
connected to an
intranet or the Internet. The notification interface may also be activated by
a cellular phone or
other telephone, or by an electronic email. In one embodiment, the
notification interface 1300
is a handheld computer of the type found widely commercially available.
Examples include the
Palm devices manufactured by PalmOne Inc., the Visor devices manufactured by
PalmOne,
Inc., the Jornada devices manufactured by Hewlett Packard, Inc., the Axim
devices
manufactured by Dell, Inc., the ale devices manufactured by Sony, Inc., and
the PocketPC
devices manufactured by Toshiba, Inc., Compaq and Symbol.
In one embodiment, the notification interface 1300 comprises a menu 1330
listing one
or more options 1340. For example, one notification option 1340 may allow the
notifying party
1210 to select a specific clinician or type of clinician to be the target
party 1230 of the
emergency notification. Another notification option 1340 may allow the
notifying party 1210
to choose to cancel the emergency notification, in the event that the
emergency notification was
sent erroneously. Additional notification options 1340 may include entries for
patient

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identification information, patient location, the type of the emergency, and
the expected time for
response.
Referring now to FIGURE 14, there is shown one embodiment of a receiving
interface
1400 from the perspective of the target party 1230. Similar to the
notification interface 1300,
the receiving interface 1400 may be operable on a variety of different
platforms and remain
practicable under the principles of the present invention. In one embodiment
illustrated in
FIGURE 13, the receiving interface 1400 is a handheld computer. The interface
1400 includes
a screen 1420 for displaying configurable information 2350. The information
2350 may include
emergency notification information such as patient identification, location of
the emergency, the
type of the emergency, and the expected time for a response.
Both the notification interface 1300 and the receiving interface 1400 are
optionally
configured with a hotkey 1350, 1460. With respect to the notification
interface 1300, the
hotkey 1350 may be configured to send an emergency notification containing
information
obtained automatically from the notification interface 1300 itself. For
example, pressing the
hotkey 1350 on the notification interface 1300 may be configured to
automatically send an
emergency notification containing the information.
Messaging & Notifications, Including Alarm/Alert Notifications
The system provides for transmitting notifications and messages. Notifications
may
include, but are not limited to: patient status lists, alarms, alerts,
infusion schedules, orders,
overrides, warnings, therapy parameters, links to additional information,
missed medications,
route verifications, comparisons, flow rate information, physician notes, loss
of communication,
low battery, administration results, etc. The system also provides for
displaying these and
additional notifications. One way in which a notification is displayed is on
the digital assistants
118. Notifications may be provided to any one of numerous clinicians and/or
charge clinicians.
As explained above, one type of notification is an alar-m/alert notification.
In the
present system, notifications may be escalated. A specific alaindalert
escalation process is
shown in FIGURE 15. Typically, a notification process is provided to transmit
notifications to
any number of clinicians 116. The identified alarm/alert escalation process
1500 of FIGURE 15
provides for notifying a series of clinicians via a clinician device 118 when
an alanri or alert is
active on a medical device such as an infusion pump 120. In a preferred
embodiment, the
clinician's device is a personal digital assistant ("PDA") 118, such as shown
in FIGS. 1 and 3,
typically having a display 118a and an audible tone or sound generator 118c.
For illustrative
purposes only, the clinician's device will hereinafter be identified in this
detailed description as
a digital assistant 118. Further, the alarm/alert escalation process 1500
provides an escalation

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process when the clinician fails to respond to the alarm/alert notification on
the digital assistant
118. When an escalation process is started, a notification is provided to
another or second
clinician's digital assistant 118 as specified in the escalation procedure.
While the alarm/alert
notification is sent to the digital assistants 118, it is understood that
typically the pump alarms
5 and alerts can only be resolved at the pump. As explained herein,
silencing of the alarm or alert
at the digital assistant 118 may or may not affect the pump.
The alarm/alert escalation process 1500 commences at block 1505 when at least
one or
both of an alarm or an alert condition is triggered at the medical device 120.
In a preferred
embodiment, shown in FIGURE 3, following the triggering of an alarm or an
alert at the
10 medical device 120, a signal containing data relating to the alarm or
alert condition is generated
and sent at block 1510 from the medical device 120, to the server 109. In a
wireless
environment, either a medical device 120 having a wireless transmitter is
provided or a medical
device 120 connected to a wireless hub 107 is provided. In the latter example,
shown in
FIGURE 3, the hub 107 receives signals from the medical devices 120 and
converts the signals
15 into a format suitable for transmission onto the system network 102 via
wireless communication
path or link 128. Further, if the hub 107 recognizes that the alarm, alert or
other notification is a
duplicate, it may discard the duplicate notification. The transmitted signal
is received by a
wireless access point 114 within the healthcare environment. The wireless
access points 114
provide an interface between the wireless communication paths (i.e., wireless
path 128) and
20 cable communication paths such as cable communication path 110 shown in
FIGURE 3.
After the server 109 receives the data relating to the alarm or alert
condition, sent at
block 1510, the server 109 conducts a precondition check at block 1515. The
precondition
check 3030 may include: associating the alarm or alert condition at the
medical device 120 with
a specific patient; associating the patient with a primary clinician, also
referred to as a first
25 clinician (this association may be conducted at the central system
servicing unit 108a); and,
associating the first clinician with that clinician's digital assistant 118.
The server 109 uses the
information gained in its precondition check at block 1515 to establish a
relationship between
the medical device 120 (and in one embodiment the specific channel 121 of the
infusion pump
120) the patient, the primary or first clinician and the first clinician's
digital assistant 118. It is
30 understood that there is a many to many relationship between patients
112 and clinicians 116.
Accordingly, numerous first clinicians, numerous second clinicians, and
numerous n-level
clinicians may be associated with a specific patient. Further, n-level
escalations are also
possible within this system.
Typically, the server 108a has stored therein the patient to clinician many-to-
many

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associations, and the patient to unit associations. The server 108a transmits
these associations
to server 109, and the server 109 stores these associations. Similarly, the
server 108a sends the
charge clinician to unit associations to the server 109 for storage.
Following the precondition check at block 1515, the server 109 determines the
appropriate channel 121 to patient 112 to clinician 116 mapping. Once the
mapping is
complete, the server 109 determines if the first clinician's digital assistant
118 is active at block
1520. If the first clinician's digital assistant 118 is active, then the
server 109 generates a signal
representative of the alarm or alert condition that exist. The signal includes
data such as the
patient's name, patient's location, room identification, bed identification,
alarm or alert type,
condition description, time, date, clinician identification and/or
prescription. In the preferred
embodiment, the signal is transmitted from the server 109 to the wireless
access point 114. The
wireless access point 114 then transmits the signal relating to the alarm or
alert condition via a
wireless communication transmission to the clinician's digital assistant 118
at block 1525.
The signal relating to the alarm or alert condition may also be transmitted at
block 1525
to a charge clinician, a secondary first clinician, or a secondary clinician.
Such a signal may be
transmitted via a wireless or wired communication. Further, the charge
clinician may be
utilizing a digital assistant 118, a desktop computer, or some other
electronic device. The
charge clinician is generally a supervisor or some person to whom the
clinicians report.
Additionally, the charge clinician may be a person who assists in workflow for
the clinicians, or
who assists in monitoring alarm or alert conditions.
The signal is received by the clinician's digital assistant 118, and
subsequently
displayed at block 1530 in FIGURE 15. This block provides for indicating the
alarm or alert
condition on the clinician's digital assistant 118. The indication on the
clinician's digital
assistant may be visual, audible, or both visual and audible. Further, the
visual indication may
include one or more of text, icons, symbols, etc. Similarly, as explained
above, the audible
indication may include a variety of audible tones at a variety of decibel
levels. The visual and
audible indicators are configurable by the hospital. FIGURE 16a discloses an
exemplar screen
shot of an alarm/alert interface list screen 1662a on the clinician's digital
assistant 118. The
alarm/alert list interface 1662a contains a list of patients that are
currently associated to active
channel alarm/alerts. As shown in FIGURE 16a, this clinician's digital
assistant 118 currently
has three active alarm/alert indications. There is an alarm condition for
patient one 1664, an
alarm condition for patient two 1666, and an alert condition for patient three
1668. Each patient
name and corresponding alarm/alert icon is a hyperlink to the appropriate pump
alarm details
interface screen, as shown in FIGURE 17. In one embodiment, the list of
patients is filtered to

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only include the patients that are currently associated to the clinician 116
logged into the digital
assistant 118 displaying this interface screen. This clinician-to-patient
association can be as a
primary clinician or as a temporary coverage clinician. A secondary clinician
can also be
accessed through the escalation process. The alarm/alert list interface 1662
is typically
accessed by clicking on an alanu/alert icon 4872 displayed on the clinician's
116 digital
assistant 118 during normal clinician workflow.
As explained above, when the alarm or alert condition is indicated on the
clinician's
digital assistant at block 1530, this indication may be provided visually,
audibly or both. When
an audible indication is provided at the clinician's digital assistant 118,
the alarm icon 4872
appears on the display 118a of the clinician's digital assistant 118. If an
audible indication is
provided, the clinician may have the ability to mute the audible indication
even though the
clinician has not responded to the alarm or alert condition. If the clinician
does silence the
alarm, the server 109 will initiate a silence timer. The visual indication
will remain even though
the audible indication has been muted. As shown in FIGURE 16a, if an
alarm/alert would be
providing an audible indication at the clinician's digital assistant 118 but
for the muting by the
clinician, a muted alarm/alert icon 4874 is provided. Further, upon escalation
of the alarm/alert
condition, if the clinician does not respond to the alarm within the timer
limit, the muting of the
audible indication may be disengaged. An alternate embodiment of the audible
indication may
be a vibration alert.
Further, it is understood that multiple alarm/alert conditions may occur
simultaneously
or in overlapping periods. Accordingly, simultaneous or overlapping signals
containing data
relating to the specific alarm or alert condition are generated and sent at
block 1510 from the
medical device 120, to the server 109. The alarm/alert signals may originate
from the same or
different medical devices 120. Further, the alarm/alert signals may relate to
the same or
different patients. Each of the alarm/alert signals, however, are individually
routed in the
alarm/alert escalation process 1500 as herein described for an individual
alarm/alert condition.
As shown in FIGURE 16a, a specific clinician may have numerous alarm/alert
indications on
his/her digital assistant 118. Another example of an alarm/alert screen is
shown on interface
screen 1662b of FIGURE 16b. As is typical in the present system, the line
referenced as 1676
in interface screen 1662b of FIGURE 16b indicates the end of a list, and
specifically the
alarm/alert indication list for a specific clinician in this interface.
FIGURE 17 illustrates a detailed patient alarm/alert interface 1765 after the
clinician
has selected to view one of the alaiin/alert indications for the patient
hyperlink on the clinician's
digital assistant 118 from the interface list 1662a of FIGURE 16a. Here, the
clinician has

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selected the alarm indication for patient one 1664. The alailidalert detail
screen 1765 provides
the clinician with a message detailing the reason for the alarm/alert. The
clinician can click on
the refresh button 4819 to update the current information displayed on the
screen 1765. As
shown on interface 1867 of FIGURE 18, multiple alarms or alerts 1878, 1882 may
exist for the
same patient. This alarm/alert interface 1867 provides a list of all active
pump alarm/alerts that
are currently associated to a given patient. These active pump alarm/alerts
can be from multiple
channels 121 and/or pumps 120, and even spread across multiple hubs 107. This
interface
screen 1867 is accessed by specifying a given patient on the pump alarm list
screen 1662.
After the signal is sent to the clinician's digital assistant at block 1525,
and received by
the primary clinician's digital assistant 118 at block 1530, a timer is
initiated at block 1535 at
the server 109. The timer has a timer limit. A typical escalation timer limit
is approximately 2
minutes; however, this limit is configurable by the hospital. At block 1540,
the system
determines if a response is provided to the alert or alarm within the timer
limit. If the timer
limit is reached without acknowledgment from the primary clinician's digital
assistant 118, the
process proceeds to block 1545. At block 1545, the system makes the further
inquiry as to
whether an acknowledgment or response to the alarm/alert condition has been
made at the
medical device 120. If no response has been made at either the primary
clinician's digital
assistant 118, the medical device 120, or by the charge clinician, then at
block 1545 the
alarm/alert process is escalated.
If at any time a loss of communication occurs after an alarm/alert condition
is triggered,
but prior to the acknowledgment of the alarm/alert condition, the alarm/alert
condition will
reassert once the loss of communication has been fixed. Similarly, if an
alarm/alert condition is
triggered after a loss of communication, the alarm/alert condition will
reassert once the
communication has been re-established.
When an alarm is escalated, the server 109 conducts another precondition check
at
block 1555. This precondition check 1555 may include: associating the patient
with a
secondary clinician (this association may be conducted at the central system
servicing unit
108a); and, associating the second clinician with that clinician's digital
assistant 118, also
referred to as the second clinician's device or second clinician's digital
assistant 118. The
server 109 uses the information gained in its precondition check at block 1555
to establish a
relationship between the medical device 120, the patient, the secondary
clinician and the second
clinician's digital assistant 118.
Following the second precondition check at block 1555, the server 109 may also

determine if the second clinician's digital assistant 118 is active. If the
second clinician's

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digital assistant 118 is active, then the server 109 generates an escalated
signal representative of
the alarm or alert condition that exists. The escalated signal similarly
includes data such as the
patient's name, patient's location, room identification, bed identification,
alarm or alert type,
condition description, time, date, clinician identification and/or
prescription. In the preferred
embodiment, the escalated signal is transmitted from the server 109 to the
wireless access point
114. The wireless access point 114 then transmits the escalated signal
relating to the alarm or
alert condition via a wireless communication transmission to the second
clinician's digital
assistant 118 at block 1555.
The escalated signal relating to the alarm or alert condition may also be
transmitted at
block 1555 to a charge clinician. Such an escalated signal may be via a
wireless or wired
communication. Further, the charge clinician may be utilizing a digital
assistant, a desktop
computer, or some other electronic device. As explained above, the charge
clinician is
generally a supervisor or some person to whom the clinicians report, or a
person who assists in
workflow for the clinicians, or who assists in monitoring alarm or alert
conditions.
The escalated signal is received by the second clinician's digital assistant
118, and
subsequently displayed at block 1560 in FIGURE 15. This block provides for
indicating the
alarm or alert condition on the second clinician's digital assistant 118. The
indication on the
second clinician's device may be visual, audible, or both visual and audible.
Further, the visual
indication may include one or more of text, icons, symbols, etc. Similarly, as
explained above,
the audible indication may include a variety of audible tones. It is
understood, however, that the
original signal, see block 1525, sent to the first clinician is still
maintained at the first clinician's
digital assistant, as shown in block 1530 of FIGURE 15. The signal at the
first clinician's
digital assistant 118 may be elevated (i.e., it may be shown in a larger size
or font, it may be
flashing, the volume of the audible alert may be louder, etc.).
After the secondary signal is sent to the clinician's digital assistant at
block 1555 and
received by the secondary clinician's digital assistant 118 at block 1560,
there are at least two
individuals (the first clinician and/or the charge clinician) and at least two
devices that have the
alarm/alert conditions active. Accordingly, any of these clinicians may
respond to the
alarm/alert condition as shown in blocks 1540 and 1565 The escalated alarm
process will
continue, at block 1570, until the alarm/alert condition is cleared either at
one of the clinician's
digital assistant 118, the charge clinician's computer or device, or at the
medical device 120.
Referring back to block 1520, if the server 109 determines that the primary
clinician's
digital assistant 118 is not active, and if at block 1545 the server 109
determines that the
alarm/alert condition still exists, the server 109 will proceed to block 1550
as discussed above

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to determine the appropriate secondary or charge clinician to send the
alarm/alert signal.
Additionally, it is understood that block 1520 may occur at any at any time
during the
alarm/alert escalation process 1500. One reason for a clinician's digital
assistant 118 being
inactive could be a loss of a signal from the server 109. As shown in the
communication loss
5 interface screen 4501 of FIGURES 45a and 45b, when the signal is lost the
digital assistant 118
will provide the clinician 116 with a screen 4501, and/or an audible/vibratory
indication,
indicating a lost signal. The communication loss screen 4501 also informs the
clinician 116 as
to which patients the signal has been lost. At screen 4501 the system 210 also
provides the
clinician 116 with trouble shooting tips to regain a signal. When a hub 107 or
digital assistant
10 118 is outside of the wireless range, pump alarms and alerts cannot be
received at the digital
assistant 118.
Other reasons for the digital assistant 118 being inactive could be the loss
of battery
power at the digital assistant 118, a loss of battery power at the wireless
hub 107, or the digital
assistant losing a signal with the access point 114. The system 210 does
provide the clinician
15 116 with a low battery screen. As shown in interface screen 4603 of
FIGURE 46, one type of
low battery screen is a screen to alert the clinician that a low battery
situation exists on a
wireless hub 107 connected to a patient's infusion pump. When a low battery
screen is
provided, the screen contains a list of patients for which infusions are
associated with that
specific hub 107. The list of patients is generally filtered to include only
the patients that are
20 currently associated to the clinician logged into the digital assistant
118 displaying the screen
4603, and also all patients that share the same infusion pump 120/hub 107 with
the logged-in
clinician. This clinician-to-patient association can be as a first clinician
or as a secondary
clinician through the escalation process. It is understood that other reasons
for the clinician's
digital assistant 118 being inactive are possible. Nevertheless, if at any
time the clinician's
25 digital assistant 118 becomes inactive, the process 1500 may proceed to
block 3100 such that
the signal may be sent to a secondary clinician and/or to the charge
clinician. Further, as
explained above with respect to a time-out feature and other features of this
disclosure, if a
communication signal is lost from either the server 109 or the medical device
120, a signal lost
message may be provided on the digital assistant 118 as shown in FIGURES 45a
and 45b.
30 At any time during the alarm/alert process, the primary clinician may
respond to the
alarm/alert signal. If the primary clinician responded to the alarm/alert
signal at block 1540, the
escalated process will be avoided. If, however, an escalated process has been
initiated at block
1550, either the primary physician or the secondary clinician may respond to
the alaiiidalert
signal at block 1565. Similarly, the alarm/alert condition may be resolved at
the medical device

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120, or by the charge clinician at any time, either before or during an
alarm/alert escalation
process. After the alarm/alert condition has been resolved, either at block
1540, block 1565, at
the medical device 120 or by the charge clinician, the audible alarm at the
medical device 120
and at the clinician's digital assistant 118 will be terminated at block 1540.
The server 109 records all alarm/alert conditions as an event at block 1585.
Recording
the event may include: recording information on the alarm/alert condition;
recording the
clinician who responded to the alarm/alert condition; recording the initial
time of the alarm/alert
condition (see block 1505); and, recording the time when the alarm/alert
condition was
rectified. Additionally, at block 1590, the server 109 will reset the timer
and update an medical
device alarm list. The alarm/alert condition may also be recorded in the
pump's event history.
Example Use Cases
FIGURE 55A ¨ FIGURE 62 are flowcharts of example operations that may be
performed using the system described herein. Example operations include
administering a new
infusion, scanning a pump channel, changing the channel a pump is assigned to,
stopping/discontinuing an infusion, resuming an infusion, and removing a pump.
In general,
each of these operations receives inputs from an electronic device, such as a
digital assistant
118, which includes information indicating the operation to be performed,
information
identifying which patient 112 is to be affected (e.g., patient ID), and
information identifying
which medication 124 for that patient 112 is to be affected (e.g., Rx ID).
This information is
then sent to the first central server 109, which confirms that channel
identification information
matches the infusion order information and confirms that the correct infusion
operation
occurred.
Administer Infusion Process
FIGURE 55A illustrates an example of an administer infusion process 5500.
Portions
of the administer infusion process 5500 are an alternate embodiment of the
comparison
procedure 5200 outlined above. The administer infusion process 5500 may be
used to start a
new infusion. In general, the administer infusion process 5500 receives inputs
from an
electronic device, such as a digital assistant 118, which includes information
indicating an
administer infusion process is to be performed, information identifying which
patient 112 is to
be affected (e.g., patient ID), and information identifying which medication
124 for that patient
112 is to be started (e.g., Rx ID). The process 5500 then sends this
infonnation to the first
central server 109, which confirms that channel identification information
matches the infusion
order information and confiams that the correct infusion is started.
More specifically, the example administer infusion process 5500 begins when
the

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second central server 108a causes the digital assistant 118 to display a list
of patients at block
5502. An example of a digital assistant display 118a showing a list of
patients is illustrated in
FIGURE 24. The list of patients is preferably limited to patients associated
with the user (e.g.,
a clinician 116) who is logged into that digital assistant 118 at the time.
Once the user selects a
patient 112, information identifying the selection and/or the patient 112 is
transmitted from the
digital assistant 118 back to the second central server 108a. Communication
between the
digital assistant 118 and the second central server 108a may be via any
suitable communication
channel such as the wireless/wired network 102 described above. The second
central server
108a then causes the digital assistant 118 to display a list of actions at
block 5504. An example
of a digital assistant display 118a showing a list of actions is illustrated
in FIGURE 25. The list
of actions is preferably limited to actions associated with the selected
patient 112. For example,
an "administer infusion" action would only be available if at least one
infusion was currently
associated with the selected patient 112.
When the user selects the "administer infusion" action from the list of
actions,
infounation identifying the action selected is sent to the second central
server 108a. In
response, the second central server 108a causes the digital assistant 118 to
display a screen
prompting the user to select a medication 124 to be infused from a list of
medications displayed
on the digital assistant 118 at block 5506. An example of a digital assistant
display 118a
showing a list of medications is illustrated in FIGURE 26. The list of
medications is preferably
retrieved from the second central server 108a database based on actual orders
for this patient
112. Of course, the list may have any number of items including no infusions
to administer or
one infusion to administer. Data indicative of the selected medication 124 is
then sent to the
second central server 108a.
Next, the second central server 108a causes the digital assistant 118 to
display a screen
prompting the user to scan a machine-readable identifier associated with the
patient 112 at
block 5508. An example of a digital assistant display 118a prompting the user
to scan a
machine-readable identifier associated with the patient 112 is illustrated in
FIGURE 36. The
user may use the scanner of the digital assistant 118 to scan a barcode label
on the patient's
wristband 112a. Alternatively, the user may manually enter the patient
identifier into the digital
assistant 118. The patient identifier is then sent to the second central
server 108a for
verification at block 5510. The second central server 108a then attempts to
lookup the patient
identifier in a database. If the patient identifier (e.g., wristband ID) does
not exist as a valid
patient identifier in the database, the second central server 108a causes the
digital assistant 118
to display an invalid patient notification at block 5512. Once the user
acknowledges the invalid

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patient notification (or the notification times out), the digital assistant
118 re-displays the screen
prompting the user to scan a machine-readable identifier associated with the
patient 112 at
block 5508.
If the patient identifier (e.g., wristband ID) does exist as a valid patient
identifier in the
database at block 5510, the second central server 108a causes the digital
assistant 118 to display
a screen prompting the user to scan a machine-readable identifier associated
with the
medication 124 to be administered at block 5514. An example of a digital
assistant display
118a prompting the user to scan a machine-readable identifier associated with
the medication
124 is illustrated in FIGURE 34. The user may use the scanner of the digital
assistant 118 to
scan the medication label 124a on a bag of medication 124 (e.g., a barcode on
an infusion bag).
Alternatively, the user may manually enter the medication identifier into the
digital assistant
118. The medication identifier is then sent to the second central server 108a
for verification at
block 5516. The second central server 108a attempts to lookup the medication
identifier in the
database. If the medication identifier (e.g., bag ID) does not exist as a
valid medication
identifier in the database, the second central server 108a causes the digital
assistant 118 to
display an invalid item notification at block 5518. Once the user acknowledges
the invalid item
notification (or the notification times out), the digital assistant 118 re-
displays the screen
prompting the user to scan a machine-readable identifier associated with the
medication 124 to
be resumed at block 5514.
Once a valid medication identifier is obtained, the second central server 108a
uses the
medication identifier to look up a patient identifier in the database. The
patient identifier from
the database is then compared to the scanned (or manually entered) patient
identifier to
determine if the scanned (or manually entered) medication 124 belongs to the
scanned (or
manually entered) patient 112 at block 5520. If the two patient identifiers do
not match, the
second central server 108a causes the digital assistant 118 to display the
invalid item
notification at block 5518.
If the two patient identifiers do match (i.e., this patient 112 goes with this
medication
124), the second central server 108a causes the digital assistant 118 to
display a screen
prompting the user to enter a route, a line, and a site at block 5522. An
example of a digital
assistant display 118a prompting the user to enter a route, a line, and a site
is illustrated in
FIGURE 37. Data indicative of the route, line, and site is then sent to the
second central server
108a for verification at block 5524. If a route mismatch occurs, the second
central server 108a
causes the digital assistant 118 to display a route mismatch notification at
block 5526. An
example of a digital assistant display 118a with a mismatch notification is
illustrated in

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FIGURE 40. Once the user acknowledges the route mismatch notification (or the
notification
times out), the digital assistant 118 re-displays the screen prompting the
user to enter a route, a
line, and a site at block 5522. If a route mismatch does not occur, the second
central server
108a causes the digital assistant 118 to display a screen asking the user to
select between a
manual prescription comparison and an automatic prescription comparison at
block 5528. If a
manual prescription comparison is selected at block 5530, the second central
server 108a causes
the digital assistant 118 to display an indication of the parameters to be
manually verified by
the user at block 5532.
Subsequently, the second central server 108a determines if there are more
items (e.g.,
medications) to administer for this patient 112 at block 5534. For example,
the infusion order
selected in block 5506 may require a primary infusion and a piggyback
infusion. If there are
more items (e.g., medications) to administer for this patient 112, the second
central server 108a
causes the digital assistant 118 to display the screen prompting the user to
scan a machine-
readable identifier associated with the medication 124 to be administered at
block 5514. An
example of a digital assistant display 118a prompting the user to scan a
machine-readable
identifier associated with the medication 124 is illustrated in FIGURE 34. If
there are no more
items (e.g., medications) to administer for this patient 112, the second
central server 108a
causes the digital assistant 118 to display a screen showing the
administration results at block
5536. An example of a digital assistant display 118a showing the
administration results is
illustrated in FIGURE 57.
The administration results are also passed to the first central server 109.
For example,
the administration results may be passed to the first central server 109 as
fowl variables (as if
submitted from a web page). The first central server 109 then checks all of
the administration
results for any failures at block 5538. If there are no failures, the first
central server 109
commits all of the new channel-patient-medication relationships to the first
central server 109
database at block 5540. The first central server 109 then returns control to
the second central
server 108a by navigating to a predefined URL associated with the second
central server 108a
at block 5542. If there are one or more failures, the first central server 109
discards channel-
patient-medication relationships associated with the failures and commits
channel-patient-
medication relationships associated with the successes to the first central
server 109 database at
block 5544. The failures may be associated with the second central server 108a
and/or the first
central server 109. Accordingly, the first central server 109 preferably
communicates failures
associated with the first central server 109 (e.g., an integrity failure) back
to the second central
server 108a when the first central server 109 returns control to the second
central server 108a

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by navigating to a predefined URL associated with the second central server
108a at block
5546.
Returning to block 5530, if an automatic prescription comparison is selected,
the second
central server 108a transmits a "prescription comparison" XML document to the
first central
5 server 109 at block 5531. The "prescription comparison" XML document
includes the patient
identifier (e.g., wristband ED), the medication identifier (e.g., bag ID), a
completion URL, and a
cancellation URL. The completion URL is a network address used if a
prescription match is
found. The cancellation URL is a network address used if a prescription match
is not found.
Once the first central server 109 receives the "prescription comparison" XML
10 document, the first central server 109 determines if the "prescription
comparison" XML
document is valid at block 5548. For example, the first central server 109 may
check if any
data normally expected in a "prescription comparison" XML document is missing
from the
received "prescription comparison" XML document. If the first central server
109 determines
that the "prescription comparison" XML document is not valid, the first
central server 109
15 causes the digital assistant 118 to display an error message indicating
to the user that the
"prescription comparison" action could not be executed at block 5550. This
display may
include a reason such as which data was missing from the "prescription
comparison" XML
document. After the user presses an "OK" button to acknowledge the error
message, the first
central server 109 returns a cancellation code to the second central server
108a via the
20 cancellation URL at block 5552.
If the first central server 109 determines that the "prescription comparison"
XML
document is valid, the first central server 109 initiates a channel scanning
process 5554.
Generally, the channel scanning process 5554 prompts the user to scan a
machine-readable
identifier associated with the "new" pump channel (e.g., pump channel 103a)
and determines if
25 the scanned channel is available (e.g., not assigned to any patient 112;
assigned to the current
patient 112, but not in use; assigned to another patient 112 and overwritten;
etc.). If the
scanned channel is not available, the "administer infusion" action is
cancelled. In such an
event, the first central server 109 returns a cancel code to the second
central server 108a via the
cancellation URL. If the scanned channel is available, a new channel-patient-
medication
30 relationship is created. The channel scanning process 5554 is described
in more detail below
with reference to FIGURE 56.
If the channel scanning process 5554 determines that the scanned channel is
valid and
available, the first central server 109 causes the digital assistant 118 to
display a screen
prompting the user to program the pump channel at block 5556. Preferably, the
digital assistant

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display 118a includes a "Compare" button and a "Cancel" button. If the user
presses the
"Cancel" button, the first central server 109 discards the new channel-patient-
medication
relationship at block 5558 and returns the cancellation code to the second
central server 108a
via the cancellation URL at block 5552. If the user presses the "Compare"
button, the first
central server 109 determines if communication with the pump channel is
operating properly at
block 5560. For example, the first central server 109 may determine that
communication with
the pump channel is not operating properly if status information has not been
received from the
channel within a predefined time period.
If communication with the pump channel is not operating properly, the first
central
server 109 causes the digital assistant 118 to display a screen indicating
that a prescription
comparison cannot be performed due to a loss of communication with the pump
channel at
block 5562. Again, the digital assistant display 118a preferably includes a
"Compare" button
and a "Cancel" button. If the user presses the "Cancel" button, the first
central server 109
discards the new channel-patient-medication relationship at block 5558 and
returns the
cancellation code to the second central server 108a via the cancellation URL
at block 5552. If
the user presses the "Compare" button, the first central server 109 rechecks
if communication
with the pump channel is operating properly at block 5560.
If communication with the pump channel is operating properly, the first
central server
109 determines if any data associated with this channel is missing at block
5564. For example,
the first central server 109 may determine that data associated with this
channel is missing if
status information received from the channel is missing an expected sequence
number. If
channel data is missing, the first central server 109 causes the digital
assistant 118 to display a
screen indicating that a prescription comparison cannot be performed due to
missing chamiel
data at block 5564. Again, the digital assistant display 118a preferably
includes a "Compare"
button and a "Cancel" button. If the user presses the "Cancel" button, the
first central server
109 discards the new channel-patient-medication relationship at block 5558 and
returns the
cancellation code to the second central server 108a via the cancellation URL
at block 5552. If
the user presses the "Compare" button, the first central server 109 rechecks
if communication
with the pump channel is operating properly at block 5560.
If no channel data is missing, the first central server 109 determines if the
channel is
already running at block 5568. For example, the first central server 109 may
determine if the
pump channel is running by reading status information received from the
channel. If the
channel is already running, the first central server 109 causes the digital
assistant 118 to display
a screen indicating that a prescription comparison cannot be performed because
the channel is

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already running at block 5570. An example of a digital assistant display 118a
indicating that a
prescription comparison cannot be performed is illustrated in FIGURE 42. The
digital assistant
display 118a may also indicate that the user should press a certain key on the
pump 120 (e.g.,
start). Again, the digital assistant display 118a preferably includes a
"Compare" button and a
"Cancel" button. If the user presses the "Cancel" button, the first central
server 109 discards
the new channel-patient-medication relationship at block 5558 and returns the
cancellation code
to the second central server 108a via the cancellation URL at block 5552. If
the user presses
the "Compare" button, the first central server 109 rechecks if communication
with the pump
channel is operating properly at block 5572.
If communication with the pump channel is not operating properly, the first
central
server 109 causes the digital assistant 118 to display a screen indicating
that a prescription
comparison cannot be performed due to a loss of communication with the pump
channel at
block 5574. Again, the digital assistant display 118a preferably includes a
"Compare" button
and a "Cancel" button. If the user presses the "Cancel" button, the first
central server 109
discards the new channel-patient-medication relationship at block 5558 and
returns the
cancellation code to the second central server 108a via the cancellation URL
at block 5552. If
the user presses the "Compare" button, the first central server 109 rechecks
if communication
with the pump channel is operating properly at block 5574. If communication
with the pump
channel is operating properly, the first central server 109 performs the
requested prescription
comparison at block 5576.
Returning to block 5568, if the channel is not running, the first central
server 109
determines if the pump channel is setup to send rate information at block
5578. If the pump
channel is not setup to send rate information, the first central server 109
causes the digital
assistant 118 to display a screen indicating that a prescription comparison
cannot be performed
because the channel is not sending rate information at block 5580. An example
of a digital
assistant display 118a indicating that a prescription comparison cannot be
performed is
illustrated in FIGURE 41. The digital assistant display 118a may also indicate
that the user
should press a certain key on the pump 120 (e.g., rate). Again, the digital
assistant display 118a
preferably includes a "Compare" button and a "Cancel" button. If the user
presses the "Cancel"
button, the first central server 109 discards the new channel-patient-
medication relationship at
block 5558 and returns the cancellation code to the second central server 108a
via the
cancellation URL at block 5552. If the user presses the "Compare" button, the
first central
server 109 rechecks if communication with the pump channel is operating
properly at block
5572. If the pump channel is setup to send rate information, the first central
server 109

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performs the requested prescription comparison at block 5576.
As part of the prescription comparison, the first central server 109 uses the
channel
identifier obtained by the channel scanning process 5554 and the patient
identifier transmitted
by the second central server 108a to look up a medication identifier in the
database (or two
medication identifiers if a primary medication 124 and a piggyback medication
124 are both
associated with this channel). The medication identifier(s) from the database
are then
compared to the scanned (or manually entered) medication identifier at block
5582. If one of
the medication identifier(s) from the database does not match the scanned (or
manually entered)
medication identifier, the first central server 109 causes the digital
assistant 118 to display an
invalid medication notification at block 5584. For example, the digital
assistant 118 may
display a message that the scanned medication 124 is not associated with the
scanned channel
and indicate the actual medication 124 assigned to the scanned channel (both
primary and
piggyback if applicable). Again, the digital assistant display 118a preferably
includes a
"Compare" button and a "Cancel" button. If the user presses the "Cancel"
button, the first
central server 109 discards the new channel-patient-medication relationship at
block 5558 and
returns the cancellation code to the second central server 108a via the
cancellation URL at
block 5552. If the user presses the "Compare" button, the first central server
109 rechecks if
communication with the pump channel is operating properly at block 5572.
As an additional part of the prescription comparison, the first central server
109 uses the
channel identifier obtained by the channel scanning process 5554 and the
patient identifier
transmitted by the second central server 108a to look up a medication rate in
the database. The
medication rate from the database is then compared to the actual rate received
from the pump
channel at block 5584. If medication rate from the database does not match the
actual rate
received from the pump channel, the first central server 109 causes the
digital assistant 118 to
display a rate mismatch notification at block 5586. An example of a digital
assistant display
118a with a mismatch notification is illustrated in FIGURE 40. For example,
the digital
assistant 118 may display a message that the rate of the channel should be
adjusted and indicate
the correct value. Again, the digital assistant display 118a preferably
includes a "Compare"
button and a "Cancel" button. If the user presses the "Cancel" button, the
first central server
109 discards the new channel-patient-medication relationship at block 5558 and
returns the
cancellation code to the second central server 108a via the cancellation URL
at block 5552. If
the user presses the "Compare" button, the first central server 109 rechecks
if communication
with the pump channel is operating properly at block 5572.
In addition, the digital assistant display 118a may include an "Accept
Mismatch"

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button. If the user presses the "Accept Mismatch" button, the first central
server 109 returns a
mismatch code and the mismatching rates to the second central server 108a via
the completion
URL at block 5588. If medication rate from the database does match the actual
rate received
from the pump channel at block 5584, the first central server 109 causes the
digital assistant
118 to display a match notification at block 5590. An example of a digital
assistant display
118a with a match notification is illustrated in FIGURE 39. Once the user
accepts the match
notification message, the first central server 109 returns a match code and
the matching rate to
the second central server 108a via the completion URL at block 5588.
Channel Scanning Process (for administer infusion process)
3.0 FIGURE
56 illustrates an example of the channel scanning process 5554 used above
with reference to FIGURE 55. Generally, the channel scanning process 5554
prompts the user
to scan a machine-readable identifier associated with a pump channel and
deteimines if the
scanned channel is available (e.g., assigned to the current patient 112, but
not in use). If the
scanned channel is not available, the "administer infusion" action is
cancelled. In such an
event, the first central server 109 returns a cancel code to the second
central server 108a via the
cancellation URL. If the scanned channel is available, a new channel-patient-
medication
relationship is created.
More specifically, the example channel scanning process 5554 begins when the
first
central server 109 causes the digital assistant 118 to display a screen
prompting the user to
select a subchannel (e.g., primary or piggyback) and scan a machine-readable
identifier
associated with the channel at block 5602. An example of a digital assistant
display 118a
prompting the user to scan a machine-readable identifier associated with the
channel is
illustrated in FIGURE 38. For example, the user may use the scanner of the
digital assistant
118 to scan a barcode label associated with the channel. Alternatively, the
user may manually
enter the channel identifier into the digital assistant 118. In addition, the
user may choose to
skip the scanning process which causes a return to the second central server
108a via the
completion URL or he may choose to cancel the scan which causes a return to
the second
central server 108a via the cancellation URL.
The channel identifier is then sent to the first central server 109 for
verification at block
5604. The first central server 109 then attempts to lookup the channel
identifier in the database.
If the channel identifier does not exist as a valid channel identifier in the
database (e.g., not
properly formatted, not configured in the first central server 109, etc.), the
first central server
109 causes the digital assistant 118 to display an invalid channel
notification at block 5606. For
example, the digital assistant 118 may display a message that the channel is
not configured in

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the first central server 109 and include buttons allowing the user to rescan
the channel identifier
or cancel out of the operation. If the user chooses to cancel the operation,
the first central
server 109 preferably sends a cancel code to the second central server 108a
via the cancellation
URL at block 5608.
Once a valid channel identifier is obtained, the first central server 109 uses
the channel
identifier to look up a patient identifier in the database. The first central
server 109 then
compares the patient identifier from the database to the scanned (or manually
entered) patient
identifier at block 5610. If a valid patient identifier is present in the
database, but the two
patient identifiers do not match (i.e., the channel is assigned to a different
patient 112), the first
central server 109 checks the database to see if the channel is running (in
either primary and/or
piggyback mode) at block 5612.
If the channel is running, the first central server 109 causes the digital
assistant 118 to
display a "cannot overwrite" error message indicating that a different patient
112 is associated
with the scanned channel and that the channel is currently running at block
5614. The error
message may also include data indicative of the patient 112 that is associated
with the scanned
channel (e.g., patient's name), the primary medication 124, and/or the
piggyback medication
124. Preferably, the user is given the option to cancel or rescan. If the user
chooses to cancel
the operation, the first central server 109 sends a cancel code to the second
central server 108a
via the cancellation URL at block 5608. If the user chooses to rescan, the
first central server
109 causes the digital assistant 118 to display the screen prompting the user
to select a
subchannel (e.g., primary or piggyback) and scan a machine-readable identifier
associated with
the channel at block 5602.
If the channel is not running, the first central server 109 causes the digital
assistant 118
to display a "continue overwrite" warning message indicating that a different
patient 112 is
associated with the scanned channel, but the channel is not currently running
at block 5616.
Preferably, the warning message indicates that continuing will overwrite
existing data (e.g.,
remove the association with the other patient 112). The warning message may
also include data
indicative of the patient 112 that is associated with the scanned channel
(e.g., patient's name),
the primary medication 124, and/or the piggyback medication 124. Preferably,
the user is given
the option to cancel, rescan, or continue. If the user chooses to cancel the
operation, the first
central server 109 sends a cancel code to the second central server 108a via
the cancellation
URL at block 5608. If the user chooses to rescan, the first central server 109
causes the digital
assistant 118 to display the screen prompting the user to select a subchannel
(e.g., primary or
piggyback) and scan a machine-readable identifier associated with the channel
at block 5602.

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An example of a digital assistant display 118a prompting the user to scan a
machine-readable
identifier associated with the channel is illustrated in FIGURE 38. If the
user chooses to
continue, the first central server 109 creates a new channel-patient-
medication relationship and
stores the new channel-patient-medication relationship in the current "web
session" at block
5618. If this new channel-patient-medication relationship is ultimately kept,
the first central
server 109 commits the new channel-patient-medication relationship to the
first central server
109 database block 5540 of FIGURE 55 as described in detail above.
If a valid patient identifier is present in the database, and the two patient
identifiers do
match (i.e., the channel is assigned to this patient 112) at block 5620, the
first central server 109
checks the database to see if the subchannel is empty at block 5622. In other
words, the first
central server 109 checks that there is no primary infusion associated with
this channel if the
primary subchannel was selected in block 5602 and checks that there is no
piggyback infusion
associated with this channel if the piggyback subchannel was selected in block
5602. If the
subchannel is empty, the first central server 109 creates a new channel-
patient-medication
relationship and stores the new channel-patient-medication relationship in the
current "web
session" at block 5618. If the subchannel is not empty, the first central
server 109 checks the
database to see if the subchannel is running (in either primary and/or
piggyback mode) at block
5624.
If the subchannel is running, the first central server 109 causes the digital
assistant 118
to display a "cannot overwrite" error message indicating that this patient 112
is already
associated with the scanned channel and that the selected subchannel is
currently running at
block 5626. The error message may also include data indicative of the patient
112 (e.g.,
patient's name), the primary medication 124, and/or the piggyback medication
124. Preferably,
the user is given the option to cancel or rescan. If the user chooses to
cancel the operation, the
first central server 109 sends a cancel code to the second central server 108a
via the
cancellation URI., at block 5608. If the user chooses to rescan, the first
central server 109
causes the digital assistant 118 to display the screen prompting the user to
select a subchannel
(e.g., primary or piggyback) and scan a machine-readable identifier associated
with the channel
at block 5602,
If the subchannel is not running, the first central server 109 causes the
digital assistant
118 to display a "continue" message indicating that this patient 112 is
associated with the
scanned channel, but the selected subchannel is not currently running at block
5628. The
message may also include data indicative of the patient 112 (e.g., patient's
name), the primary
medication 124, and/or the piggyback medication 124. Preferably, the user is
given the option

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to cancel, rescan, or continue. If the user chooses to cancel the operation,
the first central server
109 sends a cancel code to the second central server 108a via the cancellation
URL at block
5608. If the user chooses to rescan, the first central server 109 causes the
digital assistant 118
to display the screen prompting the user to select a subchannel (e.g., primary
or piggyback) and
scan a machine-readable identifier associated with the channel at block 5602.
If the user
chooses to continue, the first central server 109 creates a new channel-
patient-medication
relationship and stores the new channel-patient-medication relationship in the
current "web
session" at block 5618. When the user presses continue again, the first
central server 109
returns control to the cun-ent action (e.g., administer infusion).
Change Pump Channel Process
FIGURE 57A illustrates an example of a change pump channel process 5700. The
change pump channel process 5700 may be used (e.g., by a nurse) to change an
infusion from
one pump channel to another pump channel without losing the channel-patient-
medication
relationship in the database. In general, the change pump channel process 5700
receives inputs
from an electronic device, such as a digital assistant 118, which includes
information indicating
a change pump channel process is to be performed, information identifying
which patient 112 is
to be affected (e.g., patient ID), and information identifying which
medication 124 for that
patient 112 is to be affected (e.g., Rx ID). The process 5700 then sends this
information to the
first central server 109, which confirms that channel identification
information matches the
change pump channel order information.
More specifically, the example change pump channel process 5700 begins when
the
second central server 108a causes the digital assistant 118 to display a list
of patients for
selection at block 5702. An example of a digital assistant display 118a
showing a list of
patients is illustrated in FIGURE 24. The list of patients is preferably
limited to patients
associated with the user (e.g., a clinician 116) who is logged into that
digital assistant 118 at the
time. Once the user selects a patient 112, information identifying the
selection and/or the
patient 112 is transmitted from the digital assistant 118 back to the second
central server 108a.
Communication between the digital assistant 118 and the second central server
108a may be via
any suitable communication channel such as the wireless/wired network 102
described above.
The second central server 108a then causes the digital assistant 118 to
display a list of actions at
block 5704. An example of a digital assistant display 118a showing a list of
actions is
illustrated in FIGURE 25. The list of actions is preferably limited to actions
associated with the
selected patient 112. For example, a "change pump channel" action would only
be available if
an infusion associated with this patient 112 was currently listed in the
second central server

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108a database.
When the user selects the "change pump channel" action from the list of
actions,
information identifying the action selected is sent to the second central
server 108a. In
response, the second central server 108a causes the digital assistant 118 to
display a screen
prompting the user to scan a machine-readable identifier associated with the
medication 124 to
be affected by this "change pump channel" action at block 5706. An example of
a digital
assistant display 118a prompting the user to scan a machine-readable
identifier associated with
the medication 124 is illustrated in FIGURE 34. The user may use the scanner
of the digital
assistant 118 to scan the medication label 124a on a bag of medication 124
(e.g., a barcode on
an infusion bag). Alternatively, the user may manually enter the medication
identifier into the
digital assistant 118.
The medication identifier is then sent to the second central server 108a for
verification
at block 5708. The second central server 108a attempts to lookup the
medication identifier in
the database. If the medication identifier (e.g., bag ID) does not exist as a
valid medication
identifier in the database, the second central server 108a causes the digital
assistant 118 to
display an invalid item notification at block 5710. Once the user acknowledges
the invalid item
notification (or the notification times out), the digital assistant 118 re-
displays the screen
prompting the user to scan a machine-readable identifier associated with the
medication 124 to
be affected by this "change pump channel" action at block 5706.
If the medication identifier (e.g., bag ID) does exist as a valid medication
identifier in
the database at block 5708, the second central server 108a transmits a "change
pump channel"
XML document to the first central server 109. The "change pump channel" XML
document
includes the patient identifier (e.g., selected from list in block 5702, the
medication identifier
(e.g., bag ID), a completion URL, and a cancellation URL. The completion URL
is a network
address used if the "change pump channel" action is attempted. The
cancellation URL is a
network address used if the "change pump channel" action fails.
Once the first central server 109 receives the "change pump channel" XML
document,
the first central server 109 determines if the "change pump channel" XML
document is valid at
block 5724. For example, the first central server 109 may check if any data
normally expected
in a "change pump channel" XML document is missing from the received "change
pump
channel" XML document. If the first central server 109 determines that the
"change pump
channel" XML document is not valid, the first central server 109 causes the
digital assistant 118
to display an error message indicating to the user that the "change pump
channel" action could
not be executed at block 5726. This display may include a reason such as which
data was

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missing from the "change pump channel" XML document. After the user presses an
"OK"
button to acknowledge the error message, the first central server 109 returns
a failure code to
the second central server 108a via the cancellation URL at block 5728.
If the first central server 109 determines that the "change pump channel" XML
document is valid, the first central server 109 initiates a channel scanning
process 5730. This
channel scanning process 5730 is associated with the "old" channel (i.e., the
user is attempting
to move from and "old" channel to a "new" channel). Generally, the channel
scanning process
5730 prompts the user to scan a machine-readable identifier associated with
the "old" pump
channel and determines if the scanned channel is associated with the patient
identifier and the
medication identifier (as described in more detail below with reference to
FIGURE 58. If the
scanned channel is not associated with the patient identifier and the
medication identifier, the
"change pump channel" action is cancelled. In such an event, the first central
server 109
returns a cancel code to the second central server 108a via the cancellation
URL at block 5728.
If the scanned channel is associated with the patient identifier and the
medication
identifier (i.e., the old channel is valid), the first central server 109
causes the digital assistant
118 to display a message indicating the patient 112, the old channel of the
primary infusion,
and the old channel of the piggyback infusion at block 5732. Preferably, the
digital assistant
118 also displays a message indicating that both infusions (primary and
piggyback) are moved
by this operation, along with a "Continue" button and a "Cancel" button. If
the user presses the
"Cancel" button, the first central server 109 returns a cancel code to the
second central server
108a via the cancellation URL at block 5728.
If the user presses the "Continue" button, the first central server 109
initiates another
channel scanning process 5734. This channel scanning process 5734 is
associated with the
"new" channel (i.e., the user is attempting to move from an "old" channel to a
"new" channel).
Generally, the channel scanning process 5734 prompts the user to scan a
machine-readable
identifier associated with the "new" pump channel and determines if the
scanned channel is
available (e.g., not assigned to any patient 112; assigned to the current
patient 112, but not in
use; assigned to another patient 112 and overwritten; etc.). If the scanned
channel is not
available, the "change pump channel" action is cancelled. In such an event,
the first central
server 109 returns a cancel code to the second central server 108a via the
cancellation URL at
block 5728. The channel scanning process 5734 is described in more detail
below with
reference to FIGURE 59.
If the scanned channel is associated with the patient identifier and the
medication
identifier (i.e., the new channel is valid), the first central server 109
determines if any other

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infusions are currently associated with the new channel at block 5736. If
another infusion is
already associated with the new channel, the first central server 109 causes
the digital assistant
118 to display a message indicating that another infusion is currently
associated with the new
channel and a message asking the user if he/she would like to overwrite the
current infusion at
block 5738. Preferably, this message includes a "Yes" button, a "No" button,
and a "Cancel"
button. If the user presses the "Cancel" button, the first central server 109
returns a cancel code
to the second central server 108a via the cancellation URL at block 5728. If
the user presses
the "No" button, the first central server 109 initiates another channel
scanning process 5834.
If the user presses the "No" button, the first central server 109 attempts to
remove the
channel-patient-medication relationship in the database for the new channel at
block 5740. If
the attempt to remove the channel-patient-medication relationship in the
database for the new
channel is unsuccessful at block 5742, the first central server 109 causes the
digital assistant
118 to display a "change pump channel" error message including the patient
identifier, the
medication identifier associated with the primary infusion that was not moved
(if applicable),
and the medication identifier associated with the piggyback infusion that was
not moved (if
applicable) at block 5744. Once the user acknowledges the "change pump
channel" error
message by pressing an "OK" button, the first central server 109 returns a
failure code to the
second central server 108a via the completion URL at block 5746.
If another infusion is not already associated with the new channel at block
5736, or the
attempt to remove the channel-patient-medication relationship in the database
for the new
channel is successful at block 5742, the first central server 109 attempts to
change the channel-
patient-medication relationship in the database for both the primary and
piggyback infusions
from the old channel to the new channel at block 5748. If the attempt to move
the channel-
patient-medication relationship in the database from the old channel to the
new channel is not
successful at block 5750, the first central server 109 causes the digital
assistant 118 to display
the "change pump channel" error message.
If the attempt to move the channel-patient-medication relationship in the
database from
the old channel to the new channel is successful at block 5750, the first
central server 109
causes the digital assistant 118 to display a "change pump channel" success
message including
the patient identifier, the medication identifier associated with the primary
infusion that was
moved (if applicable), and the medication identifier associated with the
piggyback infusion that
was moved (if applicable) at block 5752. Preferably, the display also includes
a message to the
user to move the tubing to the new channel. Once the user acknowledges the
"change pump
channel" success message by pressing an "OK" button, the first central server
109 returns a

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success code to the second central server 108a via the completion URL at block
5746.
Channel Scanning Process
FIGURE 58 illustrates an example of the channel scanning process 5730 used
above
with reference to FIGURE 57. Generally, the channel scanning process 5730
prompts the user
to scan a machine-readable identifier associated with a pump channel and
determines if the
scanned channel is associated with the previously scanned patient identifier
and medication
identifier. If the scanned channel is not associated with the patient
identifier and the medication
identifier, the current action (e.g., stop, discontinue, resume, channel
change, remove pump,
etc.) is cancelled.
More specifically, the example channel scanning process 5730 begins when the
first
central server 109 causes the digital assistant 118 to display a screen
prompting the user to scan
a machine-readable identifier associated with the channel at block 5802. An
example of a
digital assistant display 118a prompting the user to scan a machine-readable
identifier
associated with the channel is illustrated in FIGURE 38. For example, the user
may use the
scanner of the digital assistant 118 to scan a barcode label associated with
the channel.
Alternatively, the user may manually enter the channel identifier into the
digital assistant 118.
The channel identifier is then sent to the first central server 109 for
verification at block
5804. The first central server 109 then attempts to look up the channel
identifier in the
database. If the channel identifier does not exist as a valid channel
identifier in the database
(e.g., not properly formatted, not configured in the first central server 109,
etc.), the first central
server 109 causes the digital assistant 118 to display an invalid channel
notification at block
5806. For example, the digital assistant 118 may display a message that the
channel is not
configured in the first central server 109 and include buttons allowing the
user to rescan the
channel identifier or cancel out of the operation. If the user chooses to
cancel the operation, the
first central server 109 preferably sends a cancel code to the second central
server 108a via the
cancellation URL at block 5808.
Once a valid channel identifier is obtained, the first central server 109 uses
the channel
identifier to look up a patient identifier in the database. The patient
identifier from the database
is then compared to the scanned (or manually entered) patient identifier at
block 5810. If the
two patient identifiers do not match, the first central server 109 causes the
digital assistant 118
to display an invalid patient notification at block 5812. For example, the
digital assistant 118
may display a message that the scanned patient 112 is not associated with the
scanned channel
and indicate the actual patient 112 assigned to the scanned channel. Again,
the PDA display
may include buttons allowing the user to rescan the channel identifier or
cancel out of the

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operation. If the user chooses to cancel the operation, the first central
server 109 preferably
sends a cancel code to the second central server 108a via the cancellation URL
at block 5808.
Once a valid channel-patient relationship is established, the first central
server 109 uses
the channel identifier and the patient identifier to look up a medication
identifier in the database
(or two medication identifiers if a primary medication 124 and a piggyback
medication 124 are
both associated with this channel). The medication identifier(s) from the
database are then
compared to the scanned (or manually entered) medication identifier at block
5814. If one of
the medication identifier(s) from the database does not match the scanned (or
manually entered)
medication identifier, the first central server 109 causes the digital
assistant 118 to display an
invalid medication notification at block 5816. For example, the digital
assistant 118 may
display a message that the scanned medication 124 is not associated with the
scanned channel
and indicate the actual medication 124 assigned to the scanned channel (both
primary and
piggyback if applicable). Again, the PDA display may include buttons allowing
the user to
rescan the channel identifier or cancel out of the operation. If the user
chooses to cancel the
operation, the first central server 109 preferably sends a cancel code to the
second central server
108a via the cancellation URL at block 5808.
If a valid channel-patient-medication relationship is established, the first
central server
109 indicates a valid channel scan occurred and returns control to the current
action (e.g.,
administer, stop, discontinue, resume, channel change, remove pump, etc.)
without issuing
additional displays to the digital assistant 118 at block 5818.
Channel Scanning Process (new channel)
FIGURE 59 illustrates an example of the channel scanning process 5734 used
above
with reference to FIGURE 57. Generally, the channel scanning process 5734
prompts the user
to scan a machine-readable identifier associated with a pump channel and
determines if the
scanned channel is available (e.g., assigned to the current patient 112, but
not in use). If the
scanned channel is not available, the current action (e.g., channel change) is
cancelled.
More specifically, the example channel scanning process 5734 begins when the
first
central server 109 causes the digital assistant 118 to display a screen
prompting the user to scan
a machine-readable identifier associated with the channel at block 5902. An
example of a
digital assistant display 118a prompting the user to scan a machine-readable
identifier
associated with the channel is illustrated in FIGURE 38. For example, the user
may use the
scanner of the digital assistant 118 to scan a barcode label associated with
the channel.
Alternatively, the user may manually enter the channel identifier into the
digital assistant 118.
The channel identifier is then sent to the first central server 109 for
verification at block

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5904. The first central server 109 then attempts to lookup the channel
identifier in the database.
If the channel identifier does not exist as a valid channel identifier in the
database (e.g., not
properly formatted, not configured in the first central server 109, etc.), the
first central server
109 causes the digital assistant 118 to display an invalid channel
notification at block 5906. For
example, the digital assistant 118 may display a message that the channel is
not configured in
the first central server 109 and include buttons allowing the user to rescan
the channel identifier
or cancel out of the operation. If the user chooses to cancel the operation,
the first central
server 109 preferably sends a cancel code to the second central server 108a
via the cancellation
URL at block 5908.
Once a valid channel identifier is obtained, the first central server 109 uses
the channel
identifier to look up a patient identifier in the database. The first central
server 109 then
compares the patient identifier from the database to the scanned (or manually
entered) patient
identifier at block 5910. If a valid patient identifier is present in the
database, but the two
patient identifiers do not match (i.e., the channel is assigned to a different
patient 112), the first
central server 109 checks the database to see if the channel is running (in
either primary and/or
piggyback mode) at block 5912.
If the channel is running, the first central server 109 causes the digital
assistant 118 to
display a "cannot overwrite" error message indicating that a different patient
112 is associated
with the scanned channel and that the channel is currently running at block
5914. The error
message may also include data indicative of the patient 112 that is associated
with the scanned
channel (e.g., patient's name), the primary medication 124, and/or the
piggyback medication
124. Preferably, the user is given the option to cancel or rescan. If the user
chooses to cancel
the operation, the first central server 109 sends a cancel code to the second
central server 108a
via the cancellation URL at block 5908. If the user chooses to rescan, the
first central server
109 causes the digital assistant 118 to display the screen prompting the user
to scan a machine-
readable identifier associated with the channel at block 5902.
Tithe channel is not running, the first central server 109 causes the digital
assistant 118
to display a "continue overwrite" warning message indicating that a different
patient 112 is
associated with the scanned channel, but the channel is not currently running
at block 5916.
Preferably, the warning message indicates that continuing will overwrite
existing data (e.g.,
remove the association with the other patient 112). The warning message may
also include data
indicative of the patient 112 that is associated with the scanned channel
(e.g., patient's name),
the primary medication 124, and/or the piggyback medication 124. Preferably,
the user is given
the option to cancel, rescan, or continue. If the user chooses to cancel the
operation, the first

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central server 109 sends a cancel code to the second central server 108a via
the cancellation
URL at block 5908. If the user chooses to rescan, the first central server 109
causes the digital
assistant 118 to display the screen prompting the user to scan a machine-
readable identifier
associated with the channel at block 5902. If the user chooses to continue,
the first central
server 109 causes the digital assistant 118 to display a message indicting
that it is okay to use
the selected channel at block 5918. When the user presses "continue" the first
central server
109 returns control to the current action (e.g., administer, channel change,
etc.) without issuing
additional displays to the digital assistant 118.
If a valid patient identifier is present in the database, and the two patient
identifiers do
match (i.e., the channel is assigned to this patient 112) at block 5920, the
first central server 109
checks the database to see if the channel is empty (e.g., no primary or
piggyback infusion
associated with this channel) at block 5922. If the channel is empty, the
first central server 109
causes the digital assistant 118 to display the message indicting that it is
okay to use the
selected channel at block 5918. If the channel is not empty, the first central
server 109 checks
the database to see if the channel is running (in either primary and/or
piggyback mode) at block
5924.
If the channel is running, the first central server 109 causes the digital
assistant 118 to
display a "cannot overwrite" error message indicating that this patient 112 is
already associated
with the scanned channel and that the channel is currently running at block
5926. The error
message may also include data indicative of the patient 112 (e.g., patient's
name), the primary
medication 124, and/or the piggyback medication 124. Preferably, the user is
given the option
to cancel or rescan. If the user chooses to cancel the operation, the first
central server 109
sends a cancel code to the second central server 108a via the cancellation URL
at block 5908.
If the user chooses to rescan, the first central server 109 causes the digital
assistant 118 to
display the screen prompting the user to scan a machine-readable identifier
associated with the
channel at block 5902.
If the channel is not running, the first central server 109 causes the digital
assistant 118
to display a "continue" message indicating that this patient 112 is associated
with the scanned
channel, but the channel is not currently running at block 5928. The message
may also include
data indicative of the patient 112 (e.g., patient's name), the primary
medication 124, and/or the
piggyback medication 124. Preferably, the user is given the option to cancel,
rescan, or
continue. If the user chooses to cancel the operation, the first central
server 109 sends a cancel
code to the second central server 108a via the cancellation URL at block 5908.
If the user
chooses to rescan, the first central server 109 causes the digital assistant
118 to display the

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screen prompting the user to scan a machine-readable identifier associated
with the channel at
block 5902. If the user chooses to continue, the first central server 109
causes the digital
assistant 118 to display a message indicting that it is okay to use the
selected channel at block
5918. When the user presses continue again, the first central server 109
returns control to the
current action (e.g., channel change) without issuing additional displays to
the digital assistant
118.
Stop/Discontinue Infusion Process
FIGURE 60 illustrates an example of a stop/discontinue infusion process 6000.
The
stop/discontinue infusion process 6000 may be used to temporarily stop (i.e.,
pause) an infusion
process or completely discontinue (i.e., end) an infusion process. In
general, the
stop/discontinue infusion process 6000 receives inputs from an electronic
device, such as a
digital assistant 118, which includes information regarding whether a stop or
a discontinue is to
be performed, information identifying which patient 112 is to be affected
(e.g., patient ID), and
information identifying which medication 124 for that patient 112 is to be
stopped or
discontinued (e.g., Rx ID). The process 6000 then sends this information to
the first central
server 109, which confirms that channel identification information matches the
stop/discontinue
order information and confiims that the correct infusion is stopped or
discontinued.
More specifically, the example stop/discontinue infusion process 6000 begins
when the
second central server 108a causes the digital assistant 118 to display a list
of patients at block
6002. An example of a digital assistant display 118a showing a list of
patients is illustrated in
FIGURE 24. The list of patients is preferably limited to patients associated
with the user (e.g.,
a clinician 116) who is logged into that digital assistant 118 at the time.
Once the user selects a
patient 112, information identifying the selection and/or the patient 112 is
transmitted from the
digital assistant 118 back to the second central server 108a. Communication
between the
digital assistant 118 and the second central server 108a may be via any
suitable communication
channel such as the wireless/wired network 102 described above. The second
central server
108a then causes the digital assistant 118 to display a list of actions at
block 6004. An example
of a digital assistant display 118a showing a list of actions is illustrated
in FIGURE 25. The list
of actions is preferably limited to actions associated with the selected
patient 112. For example,
a "stop infusion" action and a "discontinue infusion" action would only be
available if an
infusion associated with this patient 112 was currently in a running state.
When the user selects the "stop infusion" action or the "discontinue infusion"
action
from the list of actions, information identifying the action selected is sent
to the second central
server 108a. In response, the second central server 108a causes the digital
assistant 118 to

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display a screen listing all running infusions for that patient 112 and
prompting the user to scan
a machine-readable identifier associated with the medication 124 to be stopped
or discontinued
at block 6006. An example of a digital assistant display 118a prompting the
user to scan a
machine-readable identifier associated with the medication 124 is illustrated
in FIGURE 34.
The user may use the scanner of the digital assistant 118 to scan the
medication label 124a on a
bag of medication 124 (e.g., a barcode on an infusion bag). Alternatively, the
user may
manually enter the medication identifier into the digital assistant 118.
The medication identifier is then sent to the second central server 108a for
verification
at block 6008. The second central server 108a attempts to lookup the
medication identifier in
the database. If the medication identifier (e.g., bag ID) does not exist as a
valid medication
identifier in the database, the second central server 108a causes the digital
assistant 118 to
display an invalid item notification at block 6010. Once the user acknowledges
the invalid item
notification (or the notification times out), the digital assistant 118 re-
displays the screen
prompting the user to scan a machine-readable identifier associated with the
medication 124 to
be stopped or discontinued at block 6006.
If the medication identifier (e.g., bag ID) does exist as a valid medication
identifier in
the database at block 6008, the second central server 108a causes the digital
assistant 118 to
display a screen prompting the user to scan a machine-readable identifier
associated with the
patient 112 at block 6012. An example of a digital assistant display 118a
prompting the user to
scan a machine-readable identifier associated with the patient 112 is
illustrated in FIGURE 36.
The user may use the scanner of the digital assistant 118 to scan a barcode
label on a patient
wristband 112a. Alternatively, the user may manually enter the patient
identifier into the digital
assistant 118. The patient identifier is then sent to the second central
server 108a for
verification at block 6014. The second central server 108a then attempts to
lookup the patient
identifier in the database. If the patient identifier (e.g., wristband ID)
does not exist as a valid
patient identifier in the database, the second central server 108a causes the
digital assistant 118
to display an invalid patient notification at block 6016. Once the user
acknowledges the invalid
patient notification (or the notification times out), the digital assistant
118 re-displays the screen
prompting the user to scan a machine-readable identifier associated with the
patient 112 at
block 6012.
If the patient identifier (e.g., wristband ID) does exist as a valid patient
identifier in the
database at block 6014, the second central server 108a may also prompt the
user for a code
indicative of the reason for the "stop infusion" action or the "discontinue
infusion" action. If
. this reason code is not supplied, the system preferably displays a message
to the user that a

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reason code must be supplied. In addition, the second central server 108a may
timestamp the
order and/or prompt the user for a time when the action is to occur. Still
further, the second
central server 108a preferably checks the status of the infusion order to
determine if the
infusion order is active or discontinued.
If the infusion order is active, the second central server 108a determines if
the user is
attempting to issue a "stop infusion" action or a "discontinue infusion"
action based on the user
selection from block 6004 at block 6018. If the user is attempting to issue a
"stop infusion"
action, the second central server 108a sets a "DCFlag" in a "stop infusion"
XML document to
"FALSE" at block 6020. If the user is attempting to issue a "discontinue
infusion" action, the
second central server 108a sets the "DCFlag" in the "stop infusion" XML
document to "TRUE"
at block 6022. Of course, any well-known method of indicating the state of a
variable may be
used.
The "stop infusion" XML document, including the patient identifier (e.g.,
wristband
ID), the medication identifier (e.g., bag ID), a completion URL, a
cancellation URL, and the
DCFlag (indicating stop vs. discontinue) are then transmitted to the first
central server 109.
The completion URL is a network address used if the infusion is successfully
stopped or
discontinued. The cancellation URL is a network address used if the "stop
infusion" action or
the "discontinue infusion" action fails or is cancelled.
Once the first central server 109 receives the "stop infusion" XML document,
the first
central server 109 determines if the "stop infusion" XML document is valid at
block 6024. For
example, the first central server 109 may check if any data normally expected
in a "stop
infusion" XML document is missing from the received "stop infusion" XML
document. If the
first central server 109 determines that the "stop infusion" XML document is
not valid, the first
central server 109 causes the digital assistant 118 to display an error
message indicating to the
user that the "stop infusion" action or the "discontinue infusion" action
could not be executed at
block 6026. This display may include a reason such as which data was missing
from the "stop
infusion" XML document. After the user presses an "OK" button to acknowledge
the error
message, the first central server 109 returns a failure code to the second
central server 108a via
the cancellation URL at block 6028.
If the first central server 109 determines that the "stop infusion" XML
document is
valid, the first central server 109 initiates a channel scanning process 5730.
Generally, the
channel scanning process 5730 prompts the user to scan a machine-readable
identifier
associated with the pump channel currently running the infusion to be stopped
or discontinued
and determines if the scanned channel is associated with the patient
identifier and the

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medication identifier (as described in detail above with reference to FIGURE
58. If the
scanned channel is not associated with the patient identifier and the
medication identifier, the
"stop infusion" action or the "discontinue infusion" action is cancelled. In
such an event, the
first central server 109 returns a cancel code to the second central server
108a via the
cancellation URL at block 6028.
If the scanned channel is associated with the patient identifier and the
medication
identifier (i.e., the channel is valid), the first central server 109 causes
the digital assistant 118
to display a message indicating the patient 112 and infusion to be stopped
including the details
of the medication 124 to be stopped and the channel the medication 124 is on
at block 6032.
Preferably, the PDA display also includes a "Continue" button and a "Cancel"
button. In this
manner, the user may manually stop the indicated infusion and then press the
"Continue" button
to inform the first central server 109 to check if the correct infusion was
actually stopped or
discontinued. Alternatively, the user may press the "Cancel" button, at which
point the first
central server 109 returns a cancel code to the second central server 108a via
the cancellation
URL at block 6028.
If the user presses the "Continue" button, the first central server 109
determines if the
infusion was stopped by reading status information sent to the first central
server 109 by the
pump 120 at block 6034. If the pump 120 is unable to communicate with the
first central server
109, the first central server 109 generates a loss of communication event for
that channel. If
communication with a channel is lost, the status of the infusion on that
channel cannot be
changed to "stopped" or "discontinued" until communication with that channel
is restored. If
communication is working properly, but the infusion was not stopped, the first
central server
109 causes the digital assistant 118 to display a warning message indicating
that the infusion
was not stopped and indicating the patient 112 and infusion to be stopped at
block 6036.
Preferably, the display also includes an "OK" button and a "Cancel" button. If
the user presses
the "OK" button, the first central server 109 checks again to see if the
correct infusion was
actually stopped or discontinued at block 6034. If the user presses the
"Cancel" button, the first
central server 109 returns a cancel code to the second central server 108a via
the cancellation
URL at block 6028.
If the infusion is stopped at block 6034, the first central server 109 checks
if this is a
"stop infusion" action or a "discontinue infusion" action at block 6038. For
example, the first
central server 109 may check the state of a flag such as the DCFlag set by
block 6020 or block
6022. If this is a "stop infusion" action (i.e., pause infusion), the first
central server 109 returns
a success code and DCFlag=FALSE to the second central server 108a via the
completion URL

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at block 6044.
If instead this is a "discontinue infusion" action (i.e., end infusion), the
first central
server 109 preferably attempts to remove the database association between the
patient
identifier, the medication identifier, and the channel identifier for either
the primary infusion or
the piggyback infusion, but preferably not both at block 6040. If the user
wants to stop or
discontinue both a primary infusion and a piggyback infusion running on a
channel, the user
may execute the "stop infusion" action or the "discontinue infusion" action
twice, once for each
infusion. If the first central server 109 is not successful in removing the
database association at
block 6042, the first central server 109 returns a failure code to the second
central server 108a
via the cancellation URL at block 6028. If the first central server 109 is
successful in removing
the database association at block 6042, the first central server 109 returns a
success code and
DCFlag=TRUE to the second central server 108a via the completion URL at block
6044.
The first central server 109 removes the association between the patient
identifier, the
medication identifier, and the channel identifier for the selected infusion
only if a "discontinue
infusion" action is successful. Otherwise, the association is maintained. For
example, if a
"stop infusion" action is successful or a "discontinue infusion" action fails,
the association
between the patient identifier, the medication identifier, and the channel
identifier is
maintained. Similarly, the second central server 108a only updates the status
of the infusion to
"stopped" or "discontinued" upon receiving a success code from the first
central server 109.
Any other result (e.g., cancel code or failure code) causes the second central
server 108a to
keep the infusion in its previous state. Preferably, at any point in the
process 6000 the user has
the option to cancel out of the process 6000. The Stop/Discontinue process may
be utilized to
document that the infusion was restarted for purposes of the MAR.
Resume Infusion Process
FIGURE 61 illustrates an example of a resume infusion process 6100. The resume
infusion process 6100 may be used to restart a stopped (i.e., paused) infusion
process.
However, the resume infusion process 6100 may not be used to restart a
discontinued (i.e.,
ended) infusion process. In general, the resume infusion process 6100 receives
inputs from an
electronic device, such as a digital assistant 118, which includes information
indicating a
resume process is to be performed, information identifying which patient 112
is to be affected
(e.g., patient ID), and information identifying which medication 124 for that
patient 112 is to be
resumed (e.g., Rx ID). The process 6100 then sends this information to the
first central server
109, which confirms that channel identification information matches the resume
order
information and confiims that the correct infusion is resumed.

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More specifically, the example resume infusion process 6100 begins when the
second
central server 108a causes the digital assistant 118 to display a list of
patients at block 6102.
An example of a digital assistant display 118a showing a list of patients is
illustrated in
FIGURE 24. The list of patients is preferably limited to patients associated
with the user (e.g.,
a clinician 116) who is logged into that digital assistant 118 at the time.
Once the user selects a
patient 112, information identifying the selection and/or the patient 112 is
transmitted from the
digital assistant 118 back to the second central server 108a. Communication
between the
digital assistant 118 and the second central server 108a may be via any
suitable communication
channel such as the wireless/wired network 102 described above. The second
central server
108a then causes the digital assistant 118 to display a list of actions at
block 6104. An example
of a digital assistant display 118a showing a list of actions is illustrated
in FIGURE 25. The list
of actions is preferably limited to actions associated with the selected
patient 112. For example,
a "resume infusion" action would only be available if an infusion associated
with this patient
112 was currently in a stopped state.
When the user selects the "resume infusion" action foim the list of actions,
information
identifying the action selected is sent to the second central server 108a. In
response, the second
central server 108a causes the digital assistant 118 to display a screen
prompting the user to
scan a machine-readable identifier associated with the medication 124 to be
resumed at block
6106. An example of a digital assistant display 118a prompting the user to
scan a machine-
readable identifier associated with the medication 124 is illustrated in
FIGURE 34. The user
may use the scanner of the digital assistant 118 to scan the medication label
124a on a bag of
medication 124 (e.g., a barcode on an infusion bag). Alternatively, the user
may manually enter
the medication identifier into the digital assistant 118.
The medication identifier is then sent to the second central server 108a for
verification
at block 6108. The second central server 108a attempts to lookup the
medication identifier in
the database. If the medication identifier (e.g., bag ID) does not exist as a
valid medication
identifier in the database, the second central server 108a causes the digital
assistant 118 to
display an invalid item notification at block 6110. Once the user acknowledges
the invalid item
notification (or the notification times out), the digital assistant 118 re-
displays the screen
prompting the user to scan a machine-readable identifier associated with the
medication 124 to
be resumed at block 6106. If the user scans a machine-readable identifier
associated with a
medication 124 to be resumed, but the medication 124 has been discontinued,
the second
central server 108a preferably causes the digital assistant 118 to display a
message to the user
indicating that the medication 124 cannot be resumed due to its discontinued
state.

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If the medication identifier (e.g., bag ID) does exist as a valid medication
identifier in
the database at block 6108, and has not been discontinued, the second central
server 108a
causes the digital assistant 118 to display a screen prompting the user to
scan a machine-
readable identifier associated with the patient 112 at block 6112. An example
of a digital
assistant display 118a prompting the user to scan a machine-readable
identifier associated with
the patient 112 is illustrated in FIGURE 36. The user may use the scanner of
the digital
assistant 118 to scan a barcode label on a patient wristband 112a.
Alternatively, the user may
manually enter the patient identifier into the digital assistant 118. The
patient identifier is then
sent to the second central server 108a for verification at block 6114. The
second central server
108a then attempts to lookup the patient identifier in the database. If the
patient identifier (e.g.,
wristband ID) does not exist as a valid patient identifier in the database,
the second central
server 108a causes the digital assistant 118 to display an invalid patient
notification at block
6116. Once the user acknowledges the invalid patient notification (or the
notification times
out), the digital assistant 118 re-displays the screen prompting the user to
scan a machine-
readable identifier associated with the patient 112 at block 6112.
If the patient identifier (e.g., wristband ID) does exist as a valid patient
identifier in the
database at block 6114, the second central server 108a may also prompt the
user for a code
indicative of the reason for the "resume infusion" action. If this reason code
is not supplied, the
system preferably displays a message to the user that a reason code must be
supplied. In
addition, the second central server 108a may times tamp the order and/or
prompt the user for a
time when the action is to occur. Still further, the second central server
108a preferably checks
the status of the infusion order to determine if the infusion order is active
or discontinued.
If the infusion order is active, the second central server 108a transmits a
"resume
infusion" XML document to the first central server 109. The "resume infusion"
XML
document includes the patient identifier (e.g., wristband JD), the medication
identifier (e.g., bag
ID), a completion URL, and a cancellation URL. The completion URL is a network
address
used if the infusion is successfully resumed. The cancellation URL is a
network address used if
the "resume infusion" action fails or is cancelled.
Once the first central server 109 receives the "resume infusion" XML document,
the
first central server 109 determines if the "resume infusion" XML document is
valid at block
6124. For example, the first central server 109 may check if any data normally
expected in a
"resume infusion" XML document is missing from the received "resume infusion"
XML
document. If the first central server 109 determines that the "resume
infusion" XML document
is not valid, the first central server 109 causes the digital assistant 118 to
display an error

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message indicating to the user that the "resume infusion" action could not be
executed at block
6126. This display may include a reason such as which data was missing from
the "resume
infusion" XML document. After the user presses an "OK" button to acknowledge
the error
message, the first central server 109 returns a failure code to the second
central server 108a via
the cancellation URL at block 6128.
If the first central server 109 determines that the "resume infusion" XML
document is
valid, the first central server 109 initiates the channel scanning process
5730. Generally, the
channel scanning process 5730 prompts the user to scan a machine-readable
identifier
associated with the pump channel currently associated with the infusion to be
resumed and
determines if the scanned channel is associated with the patient identifier
and the medication
identifier (as described in detail above with reference to FIGURE 58). If the
scanned channel is
not associated with the patient identifier and the medication identifier, the
"resume infusion"
action is cancelled. In such an event, the first central server 109 returns a
cancel code to the
second central server 108a via the cancellation URL at block 6128.
If the scanned channel is associated with the patient identifier and the
medication
identifier (i.e., the channel is valid), the first central server 109 causes
the digital assistant 118
to display a message indicating the patient 112 and infusion to be resumed at
block 6132.
Preferably, the PDA display also includes a "Continue" button and a "Cancel"
button. In this
manner, the user may manually resume the indicated infusion and then press the
"Continue"
button to inform the first central server 109 to check if the correct infusion
was actually
resumed. Alternatively, the user may press the "Cancel" button, at which point
the first central
server 109 returns a cancel code to the second central server 108a via the
cancellation URL at
block 6128.
If the user presses the "Continue" button, the first central server 109
determines if the
infusion was resumed by reading status information sent to the first central
server 109 by the
pump 120 at block 6134. If the pump 120 is unable to communicate with the
first central server
109, the first central server 109 generates a loss of communication event for
that channel. If
communication with a channel is lost, the status of the infusion on that
channel cannot be
changed to "resumed" until communication with that channel is restored. If
communication is
working properly, but the infusion was not resumed, the first central server
109 causes the
digital assistant 118 to display a warning message indicating that the
infusion was not resumed
and indicating the patient 112 and infusion to be resumed at block 6136.
Preferably, the display
also includes an "OK" button and a "Cancel" button. If the user presses the
"OK" button, the
first central server 109 checks again to see if the correct infusion was
actually resumed at block

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6134. If the user presses the "Cancel" button, the first central server 109
returns a cancel code
to the second central server 108a via the cancellation URL at block 6128.
If the infusion is resumed at block 6134, the first central server 109 returns
a success
code to the second central server 108a via the completion URL at block 6144.
The first central
server 109 maintains the association between the patient identifier, the
medication identifier,
and the channel identifier for the selected. The second central server 108a
only updates the
status of the infusion to "running" upon receiving a success code from the
first central server
109. Any other result (e.g., cancel code or failure code) causes the second
central server 108a
to keep the infusion in its previous state. Preferably, if the user wants to
resume both a primary
infusion and a piggyback infusion running on a channel, the user may execute
the "resume
infusion" action twice, once for each infusion. The Resume process may be
utilized t document
that the infusion was restarted for purposes of the MAR.
Remove Pump Process
FIGURE 62 illustrates an example of a remove pump process 6200. The remove
pump
process 6200 may be used to terminate a channel-patient-medication
relationship in the first
central server 109 database independent of a discontinue infusion order
existing in the
pharmacy database and without going through the stop/discontinue infusion
process 6000
describe above. In general, the remove pump process 6200 receives inputs from
an electronic
device, such as a digital assistant 118, which includes information indicating
a remove pump
process is to be performed, information identifying which patient 112 is to be
affected (e.g.,
patient ID), and information identifying which medication 124 for that patient
112 is to be
affected (e.g., Rx ID). The process 6200 then sends this information to the
first central server
109, which confirms that channel identification information matches the remove
pump order
information and confirms that the correct pump 120 is removed.
More specifically, the example remove pump process 6200 begins when the second
central server 108a causes the digital assistant 118 to display a list of
patients for selection at
block 6202. An example of a digital assistant display 118a showing a list of
patients is
illustrated in FIGURE 24. The list of patients is preferably limited to
patients associated with
the user (e.g., a clinician 116) who is logged into that digital assistant 118
at the time. Once the
user selects a patient 112, information identifying the selection and/or the
patient 112 is
transmitted from the digital assistant 118 back to the second central server
108a.
Communication between the digital assistant 118 and the second central server
108a may be via
any suitable communication channel such as the wireless/wired network 102
described above.
The second central server 108a then causes the digital assistant 118 to
display a list of actions at

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block 6204. An example of a digital assistant display 118a showing a list of
actions is
illustrated in FIGURE 25. The list of actions is preferably limited to actions
associated with the
selected patient 112. For example, a "remove pump" action would only be
available if an
infusion associated with this patient 112 was currently listed in the first
central server 109
database.
When the user selects the "remove pump" action form the list of actions,
information
identifying the action selected is sent to the second central server 108a. In
response, the second
central server 108a causes the digital assistant 118 to display a screen
prompting the user to
scan a machine-readable identifier associated with the medication 124 to be
affected by this
"remove pump" action at block 6206. An example of a digital assistant display
118a prompting
the user to scan a machine-readable identifier associated with the medication
124 is illustrated
in FIGURE 34. The user may use the scanner of the digital assistant 118 to
scan the medication
label 124a on a bag of medication 124 (e.g., a barcode on an infusion bag).
Alternatively, the
user may manually enter the medication identifier into the digital assistant
118.
The medication identifier is then sent to the second central server 108a for
verification
at block 6208. The second central server 108a (or the digital assistant 118)
checks if a properly
foimatted medication identifier was received. Preferably, the second central
server 108a does
not need to check if the medication identifier matches a current infusion in
the second central
server 108a database, because the purpose of the "remove pump" action is to
remove
associations from the first central server 109 database that have no
corresponding infusions in
the second central server 108a database.
If the medication identifier (e.g., bag ID) is not properly formatted, the
second central
server 108a causes the digital assistant 118 to display an invalid item
notification at block 6210.
Once the user acknowledges the invalid item notification (or the notification
times out), the
digital assistant 118 re-displays the screen prompting the user to scan a
machine-readable
identifier associated with the medication 124 to be resumed at block 6206.
If the medication identifier (e.g., bag ID) is properly formatted at block
6208, the
second central server 108a causes the digital assistant 118 to display a
screen prompting the
user to scan a machine-readable identifier associated with the patient 112 at
block 6212. An
example of a digital assistant display 118a prompting the user to scan a
machine-readable
identifier associated with the patient 112 is illustrated in FIGURE 36. The
user may use the
scanner of the digital assistant 118 to scan a barcode label on a patient
wristband 112a.
Alternatively, the user may manually enter the patient identifier into the
digital assistant 118.
The patient identifier is then sent to the second central server 108a for
verification at block

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6214. The second central server 108a (or the digital assistant 118) then
checks if a properly
formatted patient identifier was received. Preferably, the second central
server 108a does not
need to check if the patient identifier matches a current infusion in the
second central server
108a database, because the purpose of the "remove pump" action is to remove
associations
from the first central server 109 database that have no corresponding
infusions in the second
central server 108a database. However, the second central server 108a (or the
digital assistant
118) may check if the patient identifier matches the patient 112 selected in
block 6202.
If the patient identifier (e.g., wristband ID) is not properly foiniatted, or
the patient
identifier does not match the patient 112 selected in block 6202, the second
central server 108a
causes the digital assistant 118 to display an invalid patient notification at
block 6216. Once
the user acknowledges the invalid patient notification (or the notification
times out), the digital
assistant 118 re-displays the screen prompting the user to scan a machine-
readable identifier
associated with the patient 112 at block 6212.
If the patient identifier (e.g., wristband ID) is properly formatted and
matches the
patient 112 selected in block 6202 at block 6214, the second central server
108a transmits a
"stop alarm routing" XML document to the first central server 109 at block
6217. The "stop
alarm routing" XML document includes the patient identifier (e.g., wristband
ID), the
medication identifier (e.g., bag ID), a completion URL, and a cancellation
URL. The
completion URL is a network address used if the pump 120 is successfully
removed. The
cancellation URL is a network address used if the "remove pump" action fails
or is cancelled.
Once the first central server 109 receives the "stop alarm routing" XML
document, the
first central server 109 determines if the "stop alarm routing" XML document
is valid at block
6224. For example, the first central server 109 may check if any data normally
expected in a
"stop alarm routing" XML document is missing from the received "stop alarm
routing" XML
document. If the first central server 109 determines that the "stop alarm
routing" XML
document is not valid, the first central server 109 causes the digital
assistant 118 to display an
error message indicating to the user that the "stop alarm routing" action
could not be executed
at block 6226. This display may include a reason such as which data was
missing from the
"stop alarm routing" XML document. After the user presses an "OK" button to
acknowledge
the error message, the first central server 109 returns a failure code to the
second central server
108a via the cancellation URL at block 6228.
If the first central server 109 deteimines that the "stop alarm routing" XML
document is
valid, the first central server 109 initiates the channel scanning process
5730. Generally, the
channel scanning process 5730 prompts the user to scan a machine-readable
identifier

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associated with the pump channel currently associated with the pump 120 to be
removed and
determines if the scanned channel is associated with the patient identifier
and the medication
identifier (as described in detail above with reference to FIGURE 58. If the
scanned channel is
not associated with the patient identifier and the medication identifier, the
"remove pump"
action is cancelled. In such an event, the first central server 109 returns a
cancel code to the
second central server 108a via the cancellation URL at block 6228.
If the scanned channel is associated with the patient identifier and the
medication
identifier (i.e., the channel is valid), the first central server 109 causes
the digital assistant 118
to display a message indicating the patient 112 and infusion associated with
this action at block
6232. Preferably, the FDA display also includes a "Continue" button and a
"Cancel" button. In
this manner, the user may manually stop the indicated infusion and then press
the "Continue"
button to inform the first central server 109 to check if the correct infusion
was actually
stopped. Alternatively, the user may press the "Cancel" button, at which point
the first central
server 109 returns a cancel code to the second central server 108a via the
cancellation URL at
block 6228.
If the user presses the "Continue" button, the first central server 109
determines if the
infusion was stopped by reading status information sent to the first central
server 109 by the
pump 120 at block 6234. If the infusion was not stopped, the first central
server 109 causes the
digital assistant 118 to display a warning message indicating that the
infusion was not stopped
at block 6236. Preferably, the display also includes an "Continue" button and
a "Cancel"
button. If the user presses the "Cancel" button, the first central server 109
returns a cancel code
to the second central server 108a via the cancellation URL at block 6228.
If the user presses the "Continue" button, the first central server 109
attempts to remove
the database association between the patient identifier, the medication
identifier, and the
channel identifier for either the primary infusion or the piggyback infusion,
but preferably not
both at block 6240. If the user wants to stop alarm routing associated with
both a primary
infusion and a piggyback infusion running on a channel, the user may execute
the "remove
pump" action twice, once for each infusion. If the first central server 109 is
not successful in
removing the database association at block 6242, the first central server 109
returns a failure
code to the second central server 108a via the cancellation URL at block 6228.
If the first
central server 109 is successful in removing the database association at block
6242, the first
central server 109 returns a success code to the second central server 108a
via the completion
URL at block 6244.
The first central server 109 removes the association between the patient
identifier, the

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122
medication identifier, and the channel identifier for the selected infusion
only if a "remove
pump" action is successful. Otherwise, the association is maintained. The
second central
server 108a need not update the status of the "removed" infusion upon
receiving a success code
from the first central server 109.
Secure Communication Process
As described above, the system may include a plurality of digital assistants
118 and a
plurality of medical devices (e.g., infusion pumps 120) communicating over a
wired or wireless
network. Because some of the data being transmitted is confidential medical
data, the data is
preferably encrypted and only communicated in the clear to authorized users
and devices. In
order to setup a new digital assistant 118 or medical device 120, a
commissioning phase of the
authentication process may be performed. Each time a commissioned device is
powered up, an
authentication process is preferably performed in order to verify
communication is occurring
with an authorized device and/or user. Once a device and/or user is
authenticated, secure one-
way and/or two-way communication may occur in order to pass parameters,
instructions, data,
alarms, status information, and any other type of information between digital
assistants, medical
devices, and/or servers.
Referring to FIGURE 63, a digital assistant commissioning phase (i.e., server
registration phase) of a secure communication process 6300 begins at block
6302 when the first
central server 109 creates a digital assistant user account. For example, the
digital assistant user
account may be established using Microsoft Active Directory in a well-known
manner. The
first central server 109 then generates a digital certificate for the digital
assistant 118 at block
6304. The digital certificate may be generated in any manner. For example, the
digital
certificate may be generated at the first central server 109 using Microsoft
Digital Certificate
Services in a well-known manner. The digital certificate preferably includes
the digital
assistant's public key digitally signed using the first central server's
private key. In other
words, the first central server 109 is acting as the certification authority
(CA) for the digital
assistant's digital certificate. Once the digital certificate is generated,
the first central server
109 maps the digital certificate to the user account at block 6306.
The digital assistant's digital certificate and the digital assistant's
private key are then
sent by the first central server 109 at block 6308 to the digital assistant
118 at block 6310.
Preferably, the digital assistant's digital certificate and the digital
assistant's private key are
sent to the digital assistant 118 via a secure connection. For example, an RS-
232 cable that is
not connected to any other devices may be used. In addition, the first central
server's digital
certificate is sent by the first central server 109 at block 6312 to the
digital assistant 118 at

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123
block 6314. Again, the first central server's digital certificate is
preferably sent to the digital
assistant 118 via a secure connection such as an RS-232 cable that is not
connected to any other
devices. At this point, the digital assistant 118 is commissioned (i.e.,
registered with the
server).
Of course, any method of communicating with the digital assistant 118 may be
used. In
one example, the digital assistant's private key may be stored in a memory
associated with the
digital assistant 118 (e.g., an EPROM) at the time the digital assistant 118
is manufactured. In
addition, each digital assistant 118 may have the same private key, with
different identification
codes used to distinguish one digital assistant 118 from another.
Each time a commissioned digital assistant 118 is turned on, the digital
assistant 118
and the first central server 109 must perform an authentication process in
order to move from
an unsecured wireless connection to a secured wireless connection. In the
example illustrated,
the digital assistant 118 establishes an unsecured 802.11 (wireless Ethernet)
connection with the
first central server 109 at block 6316 and block 6318. Of course, any type of
connection may
be used, such as a wired connection or a connection using another protocol.
Turning to FIGURE 64, at block 6402 the digital assistant 118 sends a request
to the
first central server 109 to establish a secure connection. The first central
server 109 receives
the digital assistant's request to establish a secure connection at block
6404. The first central
server 109 responds to the request to establish a secure connection at block
6406 by sending a
copy of the first central server's digital certificate to the digital
assistant 118 over the unsecured
connection. The digital assistant 118 receives the first central server's
digital certificate at
block 6408.
The digital assistant 118 uses the first central server's digital certificate
to authenticate
the first central server 109 at block 6410. In addition, at block 6412 the
digital assistant 118
uses the first central server's digital certificate to retrieve an embedded
uniform resource
locator (URL) associated with the first central server 109. The digital
assistant 118 can now
request data and services form the retrieved LTRL knowing it is talking to the
real first central
server 109.
Next, at block 6414 the first central server 109 sends a request to the
digital assistant
118 to establish the other half of the secure connection. The digital
assistant 118 receives the
first central server's request at block 6416. The digital assistant 118
responds to the request to
establish a secure connection at block 6418 by sending a copy of the digital
assistant's digital
certificate to the first central server 109. The first central server 109
receives the digital
assistant's digital certificate at block 6420.

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The first central server 109 uses the digital assistant's digital certificate
to authenticate
the digital assistant 118 at block 6422. The first central server 109 can now
communicate with
the digital assistant 118 knowing it is talking to a commissioned digital
assistant 118. In
addition, turning to FIGURE 65, the first central server 109 establishes what
files this digital
assistant is authorized to access by mapping a session for the digital
assistant user account to an
active directory at block 6502.
Now that the digital assistant 118 is communicating with the first central
server 109
over a secure connection, and the digital assistant 118 is cleared to access
certain files on the
first central server 109, at block 6504 the digital assistant 118 may
establish a secure
communication session with the first central server 109 by accessing the URL
retrieved from
the first central server's digital certificate. The first central server 109
also establishes the
secure communication session at block 6506. In addition, an application on the
first central
server 109 verifies the digital assistant 118 belongs to the appropriate
active directory at block
6508.
Although the digital assistant 118 may now be authenticated, the first central
server 109
still does not know the identity of the user using the digital assistant 118.
This is important
because some users may have different access rights than other users, and
certain alarms and
other data are only sent to specific users. Accordingly, an application on the
first central server
109 may request a user name and password from the user of the digital
assistant 118 at block
6510. Once the digital assistant 118 receives the request for a user name and
password at block
6512, the digital assistant 118 retrieves a user name and password from the
user via a prompt
on the digital assistant display 118a at block 6514. The user name and
password are then sent
by the digital assistant 118 at block 6516 and received by the first central
server 109 at block
6518. The application on the first central server 109 may then authenticate
the user at block
6520.
Once the user is authenticated on one server (e.g., the first central server
109), the
authentication credentials may be used to automatically authenticate the
digital assistant 118 on
another server (e.g., second central server 108a). In one example, a user may
only be
authenticated if the user is authenticated on both the first central server
109 and the second
central server 108a. Accordingly, the user name and password are preferably
synchronized
between the first central server 109 and the second central server 108a
whenever a user name or
password is created or modified.
After authenticating the user, the first central server 109 preferably returns
a token that
will be unique to the session between the user and the first central server
109. This session

CA 02514571 2005-07-26
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125
token is passed with each request (e.g., in an HTTP header or as a cookie)
made to the first
central server 109 as a means of authenticating the origin of the request and
hence the
destination of the response. Once this token is in place, the digital
assistant 118 may roam from
one wireless access point 114 to another seamlessly.
Turning to FIGURE 66, the medical device commissioning phase (i.e., server
registration phase) of the process 6300 begins at block 6602 when the first
central server 109
creates a medical device user account. For example, the medical device user
account may be
established using Microsoft Active Directory in a well-known manner. The first
central server
109 then generates a digital certificate for the medical device 120 at block
6604. The digital
certificate may be generated in any manner. For example, the digital
certificate may be
generated at the first central server 109 using Microsoft Digital Certificate
Services in a well
known manner. The digital certificate preferably includes the medical device's
public key
digitally signed using the first central server's private key. In other words,
the first central
server 109 is acting as the certification authority (CA) for the medical
device's digital
certificate. Once the digital certificate is generated, the first central
server 109 maps the digital
certificate to the user account at block 6606.
The medical device's digital certificate and the medical device's private key
are then
sent by the first central server 109 at block 6608 to the medical device 120
at block 6610.
Preferably, the medical device's digital certificate and the medical device's
private key are sent
to the medical device 120 via a secure connection such as an RS-232 cable that
is not connected
to any other devices. In addition, the first central server's digital
certificate is sent by the first
central server 109 at block 6612 to the medical device 120 at block 6614.
Again, the first
central server's digital certificate is preferably sent to the medical device
120 via a secure
connection such as an RS-232 cable that is not connected to any other devices.
At this point,
the medical device 120 is commissioned (i.e., registered with the server).
Of course, any method of communicating with the medical device 120 may be
used. In
one example, the medical device's private key may be stored in a memory
associated with the
medical device 120 (e.g., an EPROM) at the time the medical device 120 is
manufactured. In
addition, each medical device 120 may have the same private key, with
different identification
codes used to distinguish one medical device 120 from another.
Each time a commissioned medical device 120 is turned on, the medical device
120 and
the first central server 109 must perform an authentication process in order
to move from an
unsecured wireless connection to a secured wireless connection. In the example
illustrated in
FIGURE 67, the medical device 120 establishes an unsecured 802.11 (wireless
Ethernet)

CA 02514571 2005-07-26
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126
connection with the first central server 109 at block 6702 and block 6704. Of
course, any type
of connection may be used, such as a wired connection or a connection using
another protocol.
Next, at block 6706 the medical device 120 sends a request to the first
central server 109
to establish a secure connection. The first central server 109 receives the
medical device's
request to establish a secure connection at block 6708. The first central
server 109 responds to
the request to establish a secure connection at block 6710 by sending a copy
of the first central
server's digital certificate to the medical device 120 over the unsecured
connection. The
medical device 120 receives the first central server's digital certificate at
block 6712.
The medical device 120 uses the first central server's digital certificate to
authenticate
the first central server 109 at block 6714. In addition, at block 6716 the
medical device 120
uses the first central server's digital certificate to retrieve an embedded
uniform resource
locator (URL) associated with the first central server 109. The medical device
120 can now
request data and services form the retrieved URL knowing it is talking to the
real first central
server 109.
Next, at block 6718 the first central server 109 sends a request to the
medical device 120
to establish the other half of the secure connection. The medical device 120
receives the first
central server's request at block 6720. The medical device 120 responds to the
request to
establish a secure connection at block 6722 by sending a copy of the medical
device's digital
certificate to the first central server 109. The first central server 109
receives the medical
device's digital certificate at block 6724.
Turning to FIGURE 68, the first central server 109 uses the medical device's
digital
certificate to authenticate the medical device 120 at block 6802. The first
central server 109
can now communicate with the medical device 120 knowing it is talking to a
commissioned
medical device 120. In addition, the first central server 109 establishes what
files this medical
device 120 is authorized to access by mapping a session for the medical device
user account to
an active directory at block 6804.
Now that the medical device 120 is communicating with the first central server
109 over
a secure connection, and the medical device 120 is cleared to access certain
files on the first
central server 109, at block 6806 the medical device 120 may establish a
secure communication
session with the first central server 109 by accessing the URL retrieved from
the first central
server's digital certificate. The
first central server 109 also establishes the secure
communication session at block 6808. In addition, an application on the first
central server 109
verifies the medical device 120 belongs to the appropriate active directory at
block 6810.
Although the medical device 120 may now be authenticated, the first central
server 109

CA 02514571 2005-07-26
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127
still does not know the identity of the user using the medical device 120. In
many instances, no
user will be associated with a medical device 120. In some applications, this
may be important
because some users may have different access rights than other users. In
addition, a medical
device may have different "roles." For example, a medical device may have a
"one-way
communication" role or a "two-way communication" role. In this manner, a
medical device
120 capable of two-way communication may be placed in a system that expects
only one-way
communication devices. Similarly, a system that is capable of handling both
one-way
communication devices and two-way communication devices may need to be told
the type of
device that is connected.
Accordingly, an application on the first central server 109 may request a user
name and
password from the user of the medical device 120 at block 6812. Once the
medical device 120
receives the request for a user name and password at block 6814, the medical
device 120
retrieves a user name and password from the user via a prompt on the medical
device 120 or an
associated digital assistant display 118a at block 6816. The user name and
password are then
sent by the medical device 120 (or other device) at block 6902 of FIGURE 69
and received by
the first central server 109 at block 6904. The application on the first
central server 109 may
then authenticate the user at block 6906.
Once the user is authenticated on one server (e.g., the first central server
109), the
authentication credentials may be used to automatically authenticate the user
on another server
(e.g., second central server 108a). In one example, a user may only be
authenticated if the user
is authenticated on both the first central server 109 and the second central
server 108a.
Accordingly, the user name and password are preferably synchronized between
the first central
server 109 and the second central server 108a whenever a user name or password
is created or
modified.
After authenticating the user, the first central server 109 preferably returns
a token that
will be unique to the session between the user and the first central server
109. This session
token is passed with each request (e.g., in an HTTP header or as a cookie)
made to the first
central server 109 as a means of authenticating the origin of the request and
hence the
destination of the response.
Secure one-way communications may now be sent from the medical device 120 to
the
digital assistant 118. For example, the medical device 120 may report
settings, generate alarms,
etc. In the example illustrated, the medical device 120 determines data to be
sent to the digital
assistant 118 via the first central server 109 at block 6908. This data is
then sent to the first
central server 109 at block 6910 and received by the first central server 109
at block 6912. The

CA 02514571 2012-06-08
128
first central server 109 may then determine which user(s) are authorized to
receive this
data at block 6914 and which digital assistant(s) 118 those users are
currently associated
with at block 6916. For example, a lookup table stored in the first central
server 109
database may be used.
The first central sever 109 then sends the data to the appropriate digital
assistant(s) 118 at block 6918 and the digital assistant(s) 118 receive and
display the data
at block 6920. In addition, secure two-way communications may be accomplished.
For
example, a digital assistant 118 and/or the first central server 109 may send
data,
commands, setup information, or any other type of information to the medical
device
120.
It should be emphasized that the above-described embodiments of the present
invention, particularly, any "preferred" embodiments, are possible examples of

implementations, merely set forth for a clear understanding of the principles
of the
invention. The scope of the claims should not be limited by the preferred
embodiments
set forth in the examples, but should be given the broadest interpretation
consistent with
the description as a whole.

A single figure which represents the drawing illustrating the invention.

For a clearer understanding of the status of the application/patent presented on this page, the site Disclaimer , as well as the definitions for Patent , Administrative Status , Maintenance Fee  and Payment History  should be consulted.

Admin Status

Title Date
Forecasted Issue Date 2019-01-15
(86) PCT Filing Date 2004-01-30
(87) PCT Publication Date 2004-08-19
(85) National Entry 2005-07-26
Examination Requested 2009-01-07
(45) Issued 2019-01-15

Abandonment History

There is no abandonment history.

Maintenance Fee

Description Date Amount
Last Payment 2019-12-20 $450.00
Next Payment if small entity fee 2021-02-01 $225.00
Next Payment if standard fee 2021-02-01 $450.00

Note : If the full payment has not been received on or before the date indicated, a further fee may be required which may be one of the following

  • the reinstatement fee set out in Item 7 of Schedule II of the Patent Rules;
  • the late payment fee set out in Item 22.1 of Schedule II of the Patent Rules; or
  • the additional fee for late payment set out in Items 31 and 32 of Schedule II of the Patent Rules.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Registration of Documents $100.00 2005-07-26
Filing $400.00 2005-07-26
Maintenance Fee - Application - New Act 2 2006-01-30 $100.00 2005-07-26
Maintenance Fee - Application - New Act 3 2007-01-30 $100.00 2007-01-10
Maintenance Fee - Application - New Act 4 2008-01-30 $100.00 2008-01-08
Request for Examination $800.00 2009-01-07
Maintenance Fee - Application - New Act 5 2009-01-30 $200.00 2009-01-07
Maintenance Fee - Application - New Act 6 2010-02-01 $200.00 2010-01-06
Maintenance Fee - Application - New Act 7 2011-01-31 $200.00 2011-01-07
Maintenance Fee - Application - New Act 8 2012-01-30 $200.00 2012-01-30
Maintenance Fee - Application - New Act 9 2013-01-30 $200.00 2013-01-03
Maintenance Fee - Application - New Act 10 2014-01-30 $250.00 2014-01-13
Maintenance Fee - Application - New Act 11 2015-01-30 $250.00 2015-01-07
Maintenance Fee - Application - New Act 12 2016-02-01 $250.00 2016-01-11
Maintenance Fee - Application - New Act 13 2017-01-30 $250.00 2017-01-10
Maintenance Fee - Application - New Act 14 2018-01-30 $250.00 2018-01-02
Final Fee $846.00 2018-11-19
Maintenance Fee - Application - New Act 15 2019-01-30 $450.00 2018-11-26
Maintenance Fee - Patent - New Act 16 2020-01-30 $450.00 2019-12-20
Current owners on record shown in alphabetical order.
Current Owners on Record
BAXTER INTERNATIONAL INC.
Past owners on record shown in alphabetical order.
Past Owners on Record
LETELLIER, LAURA M.
MARTUCCI, JAMES P.
SIMPSON, THOMAS L.
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.

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Claims 2005-07-26 2 53
Drawings 2005-07-26 58 2,764
Abstract 2005-07-26 2 69
Description 2005-07-26 128 8,737
Representative Drawing 2005-10-07 1 16
Cover Page 2005-10-07 1 42
Description 2012-06-08 128 8,811
Claims 2012-06-08 2 48
Description 2013-11-29 128 8,818
Claims 2013-11-29 2 55
Claims 2014-12-05 2 66
Description 2014-12-05 128 8,820
Description 2016-01-11 129 8,827
Claims 2016-01-11 2 71
Claims 2016-11-30 3 90
PCT 2005-07-26 62 1,628
Assignment 2005-07-26 6 219
Correspondence 2010-02-25 1 25
Prosecution-Amendment 2009-01-07 1 58
Prosecution-Amendment 2009-05-22 1 27
Prosecution-Amendment 2011-12-12 3 92
Prosecution-Amendment 2012-06-08 8 228
Prosecution-Amendment 2013-05-31 3 86
Prosecution-Amendment 2013-11-29 9 395
Prosecution-Amendment 2014-06-06 2 75
Prosecution-Amendment 2014-12-05 8 340
Prosecution-Amendment 2015-07-10 4 238
Prosecution-Amendment 2016-01-11 10 430
Prosecution-Amendment 2016-05-31 4 256
Prosecution-Amendment 2016-11-30 12 476
Prosecution-Amendment 2017-06-05 3 166
Prosecution-Amendment 2017-11-24 61 1,458
Drawings 2017-11-24 59 1,333
Description 2016-11-30 129 8,934
Correspondence 2018-11-19 2 76
Representative Drawing 2018-12-19 1 9
Cover Page 2018-12-19 1 37