U.S. patent application number 11/355216 was filed with the patent office on 2006-06-22 for transfer set for use with a pharmaceutical compounder.
Invention is credited to Aleandro DiGianfilippo, Richard R. Pierce.
Application Number | 20060133966 11/355216 |
Document ID | / |
Family ID | 23352403 |
Filed Date | 2006-06-22 |
United States Patent
Application |
20060133966 |
Kind Code |
A1 |
DiGianfilippo; Aleandro ; et
al. |
June 22, 2006 |
Transfer set for use with a pharmaceutical compounder
Abstract
Information management systems and methods can be used with at
least one pharmaceutical compounding device. The systems and
methods comprise a controller coupled to the compounding device. A
compounding control manager resides on the controller to receive
compounding order input and generate control commands to the
compounding device based, at least in part, upon the compounding
order input. An order process control manager is in data
communication with the compounding control manager to communicate
compounding order input to the compounding control manager. The
order entry process manager includes an order function for
receiving entry of compounding order input through a browser-based
interface. The browser-based interface can include an order entry
workstation separate from the compounding device, or a network of
order entry workstations separate from the compounding device, or
can reside on the controller.
Inventors: |
DiGianfilippo; Aleandro;
(Scottsdale, AZ) ; Pierce; Richard R.; (Glendale,
AZ) |
Correspondence
Address: |
RATNERPRESTIA
P O BOX 980
VALLEY FORGE
PA
19482-0980
US
|
Family ID: |
23352403 |
Appl. No.: |
11/355216 |
Filed: |
February 15, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10335552 |
Dec 31, 2002 |
|
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11355216 |
Feb 15, 2006 |
|
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60344869 |
Dec 31, 2001 |
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Current U.S.
Class: |
422/400 |
Current CPC
Class: |
G06Q 10/10 20130101;
G16H 15/00 20180101; G16H 40/63 20180101; G16H 20/10 20180101 |
Class at
Publication: |
422/100 |
International
Class: |
B01L 3/02 20060101
B01L003/02 |
Claims
1. A fluid transfer set comprising first transfer tubing, a second
transfer tubing, a manifold joining the first transfer tubing and a
second transfer tubing in flow communication, a first one way valve
in-line in the first transfer tubing to allow fluid flow in the
first transfer tubing toward the manifold but not in an opposite
direction, the first one-way valve having a first cracking
pressure, and a second one way valve in-line in the second transfer
tubing to allow fluid flow in the second transfer tubing toward the
manifold but not in an opposite direction, the second one-way valve
having a second cracking pressure different than the first cracking
pressure.
Description
RELATED APPLICATIONS
[0001] This application is a Divisional application of U.S.
application Ser. No. 10/335,552, filed Dec. 31, 2002 which claimed
the benefit of priority of United States Provisional Application
No. 60/344,869, filed Dec. 31, 2001.
FIELD OF THE INVENTION
[0002] This invention relates to systems and methods for
compounding of liquids and/or drugs intended to be administered to
a human being or an animal.
BACKGROUND OF THE INVENTION
[0003] Pharmaceutical compounding involves the transfer of two or
more of individual prescribed liquids and/or drugs from multiple
source containers into a single collecting container, for the
purpose of administering the mix of liquids and/or drugs
intravenously to an individual in need. Presently, the
pharmaceutical compounding of liquids and/or drugs takes place
primarily at one of three sites. These are: (1) hospital based
compounding performed by pharmacists or pharmacy technicians in the
hospital pharmacy; (2) alternate site based compounding performed
primarily by pharmacists or pharmacy technicians in the home care
company pharmacy; and (3) compounding centers operated by any one
of several major pharmaceutical or hospital supply companies.
[0004] The operational and performance demands upon these
compounding systems and methodologies are becoming increasingly
more complex and sophisticated, in terms of, e.g., safety, speed,
reliability, accuracy, and overall user friendliness and
ergonomics. The operational and performance demands upon these
compounding systems and methodologies are also becoming
increasingly more complex and sophisticated with regard to the
management of patient and prescription information, in terms of
providing an information path that starts with the clinician and
finishes with the final product delivery to the end patient.
SUMMARY OF THE INVENTION
[0005] One aspect of the invention provides information management
systems and methods adapted to be used with at least one
pharmaceutical compounding device. The systems and methods comprise
a controller coupled to the compounding device. A compounding
control manager resides on the controller to receive compounding
order input and generate control commands to the compounding device
based, at least in part, upon the compounding order input. An order
process control manager is in data communication with the
compounding control manager to communicate compounding order input
to the compounding control manager. The order entry process manager
includes an order function for receiving entry of compounding order
input through a browser-based interface.
[0006] The browser-based interface can include an order entry
workstation separate from the compounding device, or a network of
order entry workstations separate from the compounding device, or
can reside on the controller.
[0007] The order entry process manager can include a database
function for retaining the compounding order input in memory, a
printing function for generating printable output, e.g., labeling,
based, at least in part, upon the compounding order input, or a
report function for generating reporting output based, at least in
part, upon the compounding order input.
[0008] Another aspect of the invention provides a pharmaceutical
compounding device that comprises at least one pump element, a
controller coupled to the pumping element, and a compounding
control manager residing on the controller to receive compounding
order input and generate control commands to the pump element
based, at least in part, upon the compounding order input.
According to this aspect of the invention, the compounding control
manager includes a verification function that requires a prescribed
bar code input before generation of the control commands. The bar
code input can include, e.g., a source solution identification,
and/or a source solution lot number, and/or a source solution
expiration date.
[0009] Another aspect of the invention provides an interface for
performing a pharmaceutical compounding procedure using a
compounding device. The interface comprises a controller coupled to
the compounding device, a display screen coupled to the controller,
and a compounding control manager residing on the controller to
receive compounding order input and generate control commands to
the compounding device based, at least in part, upon the
compounding order input. According to this aspect of the invention,
the compounding control manager includes a graphical user interface
generated on the display screen that includes at least one
touch-screen function for receiving compounding order input. The
touch-screen function can affect, e.g., the selection of a source
solution, or the selection of an amount of liquid to be
transferred. The compounding control manager can also include a
help function executed through the graphical user interface, or an
informational video executed through the graphical user
interface.
[0010] Another aspect of the invention provides an interface for
performing a pharmaceutical compounding procedure using a
compounding device. The interface comprises a controller coupled to
the compounding device, a display screen coupled to the controller,
and a compounding control manager residing on the controller to
receive compounding order input and generate control commands to
the compounding device based, at least in part, upon the
compounding order input. According to this aspect of the invention,
the compounding control manager includes at least one informational
video displayable on the display screen.
[0011] Another aspect of the invention provides a pharmaceutical
compounding device that comprises a driver and a drive shaft
coupled to the driver for rotation. The drive shaft extends along a
first axis. The device also includes an idler shaft that extends
along a second axis offset from the first axis. A peristaltic pump
rotor is carried on the idler shaft. A drive gear is carried on the
drive shaft and coupled to the peristaltic pump rotor. A clutch
assembly is carried on the drive shaft and coupled to the drive
gear. The clutch assembly is operable in a first mode to disengage
the drive gear from the drive shaft and a second mode to engage the
drive gear with the drive shaft. The clutch assembly thereby
selectively imparts rotation of the drive shaft to the peristaltic
pump rotor.
[0012] Another aspect of the invention provides a fluid transfer
set. The set comprises first transfer tubing, second transfer
tubing, and a manifold that joins the first transfer tubing and
second transfer tubing in flow communication. A first one way valve
is in-line in the first transfer tubing to allow fluid flow in the
first transfer tubing toward the manifold but not in an opposite
direction. The first one-way valve has a first cracking pressure. A
second one way valve is in-line in the second transfer tubing to
allow fluid flow in the second transfer tubing toward the manifold
but not in an opposite direction. The second one-way valve has a
second cracking pressure different than the first cracking
pressure. When used in pharmaceutical compounding, the transfer set
can mediate lipid hazing.
[0013] Other features and advantages of the inventions are set
forth in the following specification and attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of a pharmaceutical compounding
system that includes a compounding device that, in use, mixes or
compounds two or more selected liquids and/or drugs intended to be
administered to a human being or an animal.
[0015] FIG. 2A is a view of a disposable transfer set that can be
used in association with the compounding device shown in FIG.
1.
[0016] FIGS. 2B and 2C are enlarged views, partially broken away
and in section, of an embodiment of a manifold that the transfer
set shown in FIG. 2A can incorporate to mediate against lipid
hazing.
[0017] FIGS. 2D and 2E are enlarged views, partially broken away
and in section, of another embodiment of a manifold that the
transfer set shown in FIG. 2A can incorporate to mediate against
lipid hazing.
[0018] FIG. 2F is a view of a portion of the disposable transfer
set shown in FIG. 2A, which includes a transfer tube organizer to
facilitate use of the transfer set with the compounding device
shown in FIG. 1.
[0019] FIG. 3 is a perspective view of the system shown in FIG. 1
with the transfer set shown in FIG. 2A mounted for use on the
compounding device. FIG. 4 is a perspective view of the compounding
device shown in FIG. 1, with its peristaltic pumping station open
for loading a transfer set of the type shown in FIG. 2A.
[0020] FIG. 5 is a perspective view of a compounding device shown
in FIG. 4, with a transfer set mounted in the peristaltic pumping
station.
[0021] FIG. 6A is a perspective side view of the compounding device
shown in FIG. 4 with its exterior case removed to show the
peristaltic pump components and other internal components.
[0022] FIG. 6B is an exploded perspective view of the peristaltic
pump components shown in FIG. 6A.
[0023] FIG. 7 is a top view of the compounding device shown in FIG.
6A.
[0024] FIGS. 8A to 8F are schematic views of alternative
configurations of linked and/or networked systems that incorporate
the compounding device shown in FIG. 1.
[0025] FIGS. 9A to 9W are representative screens of a graphical
user interface that a compounding control manager function residing
on the compounding device shown in FIG. 1 can generate in the
process of enabling and controlling a compounding procedure. FIGS.
10A to 10E are system flow charts of representative functional
modules of an order entry process manager function that, when used
in association with the compounding control manager function of the
compounding device shown in FIG. 1, provides enhanced compounding
order entry and processing capabilities that can be accessed by
browsers installed on remote workstations.
[0026] FIGS. 11A to 11I are representative screens of a
browser-based graphical user interface that makes accessible to a
remote workstation the functional modules of the order entry
process manager shown in FIGS. 10A to 10E.
[0027] FIG. 12 is a representative view of labeling that the order
entry process manager shown in FIGS. 10A to 10E and FIGS. 11A to
11I can generate.
[0028] FIG. 13 is a schematic view of a controller that the
compounding device shown in FIG. 1 can incorporate, which can
execute the compounding control manager and order entry process
manager functions shown in FIGS. 9A to 9W; 10A to 10E; 11A to
11I.
[0029] FIG. 14 are representative screens of a training/help
video-audio function that can be integrated with the compounding
control manager of the compounding device shown in FIG. 1.
[0030] The invention may be embodied in several forms without
departing from its spirit or essential characteristics. The scope
of the invention is defined in the appended claims, rather than in
the specific description preceding them. All embodiments that fall
within the meaning and range of equivalency of the claims are
therefore intended to be embraced by the claims.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0031] FIG. 1 shows a pharmaceutical compounding system 10. The
system 10 can be used for mixing or compounding two or more
selected liquids and/or drugs intended to be administered to a
human being or an animal. In use, the system 10 serves to transfer
two or more of individual prescribed liquids and/or drugs from
multiple source containers (e.g., individual vials, bottles,
syringes, or bags) into a single collecting container (e.g., a
bottle, syringe, or bag), so that the mix of liquids and/or drugs
can be administered (e.g., intravenously) to an individual in
need.
[0032] As one example, due to injury, disease, or trauma, a patient
may need to receive all or some of their nutritional requirements
intravenously. In this situation, the patient will typically
receive a basic solution containing a mixture of amino acids,
dextrose, and fat emulsions, which provide a major portion of the
patient's nutritional needs, which is called total parenteral
nutrition, or, in shorthand, TPN. In this arrangement, a physician
will prescribe a mixture of amino acids, dextrose, and fat
emulsions to be administered, as well as the frequency of
administration. To maintain a patient for an extended period of
time on TPN, smaller volumes of additional additives, such as
vitamins, minerals, electrolytes, etc., are also prescribed for
inclusion in the mix. Using the system 10, under the supervision of
a pharmacist, the prescription order is entered and individual
doses of the prescribed liquids, drugs, and/or additives are
accordingly transferred from separate individual source containers
for mixing in a single container for administration to the
individual.
[0033] There are other environments where the system 10 is well
suited for use. For example, in the medical field, the system 10
can be used to compound liquids and/or drugs in support of
chemotherapy, cardioplegia, therapies involving the administration
of antibiotics and/or blood products therapies, and in
biotechnology processing, including diagnostic solution preparation
and solution preparation for cellular and molecular process
development. Furthermore, the system 10 can be used to compound
liquids outside the medical field.
[0034] Nevertheless, for the purpose of explaining the features and
benefits of the system 10, the illustrated embodiment describes use
of the system 10 in support of TPN.
I. System Overview
[0035] The system 10 includes three principal components. These are
(i) a liquid transfer set 12 (see FIG. 2A), which, in use, couples
a final solution container 14 to individual solution source
containers 16; (ii) a compounding or solution mixing device 18 (see
FIG. 1), which, in use (see FIG. 3), interacts with the transfer
set 12 to transfer liquids from the solution source containers 16
into the final solution container 14; and (iii) a controller 20
(see FIG. 1) that governs the interaction to perform a compounding
or solution mixing procedure prescribed by a physician, which is
typically carried out by a trained clinician at a compounding site
under the supervision of a pharmacist.
[0036] The compounding device 18 and controller 20 are intended to
be durable items capable of long-term use. In the illustrated
embodiment (see FIG. 1), the compounding device 18 is mounted
inside a housing or case 22, and the controller 20 is mounted, in
most part, within a control panel 24 mounted to a surface outside
the case 22. The case 22 presents a compact footprint, suited for
set up and operation upon a tabletop or other relatively small
surface. The case 22 and panel 24 can be formed into a desired
configuration, e.g., by molding or forming. The case 22 and panel
24 are preferably made from a lightweight, yet durable material,
e.g., plastic or metal.
[0037] The transfer set 12 (FIG. 2A) is intended to be a sterile,
single use, disposable item. As FIG. 3 shows, before beginning a
given compounding procedure, the operator loads the various
components of the transfer set 12 in association with the device
18.
[0038] As illustrated, the device 18 includes a weigh station 26
that, in use, carries the final solution container 14 (as FIG. 3
shows). The weigh station 26 includes a support arm 28, which in
the illustrated embodiment, is attached to a side or bottom of the
case 22. The weigh station 26 also includes a conventional load
cell 30, which suspends from a top of the support arm 28. During
compounding, the final solution container 14 hangs from a hanger H
on the load cell 30 (see FIG. 3). As also illustrated, the device
18 includes a source solution support frame 32. The support frame
32 carries several individual hangers H, which, during compounding,
support the individual source containers 16.
[0039] As illustrated, the support frame 32 comprises a separate
component; however, the support frame 32 can be attached in a
suitable manner to the case 22. Typically, during compounding, the
device 18, with source containers 16 and final container 14, are
located within a laminar flow hood in a "clean room"
environment.
[0040] The transfer set 12 shown in FIG. 2A can in general include
lengths of source transfer tubing 34, which are joined at one end
to a common junction or manifold 36. The opposite ends of the
source transfer tubing 34 each includes a spike 38 or suitable
releasable coupling, which can be inserted in conventional fashion
through a diaphragm carried by the associated source solution
container 16, to open flow communication between that source
solution container 16 and the respective source transfer tubing 34.
A length of final transfer tubing 40 is coupled to the final
solution container 14. The opposite end of the final transfer
tubing 40 includes a spike 42 or suitable releasable coupling,
which can be inserted into an outlet 44 in the manifold 36, to
couple the final solution container 14 to the source solution
containers 16. The source transfer tubing 34 and the final transfer
tubing 40 can be made from flexible, medical grade plastic
material, such as polyvinyl chloride plasticized with
di-2-ethylhexyl-phthalate. One or more of the source containers 16
or final containers 14 can likewise be made from medical grade
plastic material selected for inertness and compatibility with the
intended source solution. Likewise, one or more of the source or
final containers 16 or 14 can be made from glass.
[0041] Each source transfer tubing 34 includes an in-line pump
segment 46 between the spike 38 and the manifold 36. The pump
segments 34 can be made, e.g., from silicone rubber. Each source
transfer tubing 34 also includes an in-line, one way valve 48
(e.g., a duckbill, disk, or umbrella valve)--which, in the
illustrated embodiment, is carried within the manifold 36 (see FIG.
2B)--which permits liquid flow from the source containers 16 toward
the manifold 36, but prevents backflow from the manifold 36 toward
any of the source containers 16. Each valve 48 opens in response to
forward fluid flow, to allow liquid flow into the manifold 36 and
through the spike-receiving outlet 44 (i.e., toward the final
solution container 14). Each valve 48 closes in response to back
flow of liquid in the manifold 36 from the outlet 44.
[0042] Each pump segment 46 is designed for use in association with
a peristaltic pump rotor. Accordingly, as FIG. 4 shows, the
compounding device 18 includes a peristaltic pumping station 50. As
FIG. 4 shows, the peristaltic pumping station 50 occupies a pump
bay 52 or compartment formed in the device. As shown, the
peristaltic pumping station 50 includes an axial array of
individual peristaltic pump rotor assemblies 54, although non-axial
arrays can be used. Furthermore, the pumping station 50 can
includes multiple side-by-side banks of peristaltic pump rotor
assemblies 54.
[0043] The peristaltic pumping station 50 includes a door 56, which
opens and closes the pump bay 52. The door 56 opens (as FIG. 4
shows) to allow loading of a selected one of the pump segments 46
in association with a selected one of the peristaltic pump rotor
assemblies 54, as FIG. 5 shows. The door closes (as FIG. 3 shows)
to enclose the peristaltic pumping station 50 during operation.
Desirably, the controller 20 is coupled to an electrical interlock
66 (see FIG. 13) to prevent operation of the peristaltic pump rotor
assemblies 54 when the door 56 is opened.
[0044] The controller 20 executes a compounding protocol or
procedure based upon prescribed data entry orders and preprogrammed
pump control rules, which also can include other input from the
operator. During operation, the peristaltic pump rotor assemblies
54 are individually, selectively operated in series--or
simultaneously, selectively operated in parallel--as dictated by
the controller 20, to transfer desired amounts of source solutions
from the individual source containers 16 through the manifold 36
and into the final container 14. The load cell 30 is coupled to the
controller 20, to gravimetrically monitor the incremental transfer
of the individual source solutions into the final container 14. The
controller 20 monitors incremental changes in weight, which are
processed according to preprogrammed rule to govern the speed at
which a given peristaltic pump assembly 54 is operated and,
ultimately, stopped when the prescribed amount of source solution
is delivered.
[0045] The controller 20 (see FIG. 13) can comprises a main
processing unit (MPU) 58. The MPU 58 comprises a conventional PC
that is, in the illustrated embodiment, mounted within the control
panel 24, outside the case 22 of the compounding device 18.
Alternatively, the MPU 58 could be mounted within the case 22 of
the compounding device 18. The MPU 58 can comprise one or more
conventional microprocessors that support the Microsoft.RTM.
Windows.RTM. operating environment. The MPU 58 includes
conventional RAM 122 and a conventional nonvolatile memory device
74, such as a hard disk drive. The MPU 50 includes an input device
124 to upload programs into the memory device 74, e.g., a
CD-reader. In the illustrated embodiment, a compounding control
manager function 72 resides as process software in the memory
device 74 of the MPU 58.
[0046] In the illustrated embodiment, the controller 20 also
includes a supervisor CPU 126 and peripheral processing unit (PPU)
60. Both the CPU 126 and PPU 60 are desirably implemented on a
printed circuit board. The CPU comprises a conventional
microprocessor capable of running the uC/OS-II operating system.
The PPU is a dedicated microchip PIC, driven by firmware specific
to its processing tasks and control functions. In the illustrated
embodiment, the CPU 126 and PPU 60 are mounted inside an
electronics bay 62 or compartment with the case 22 of the
compounding device 18 (see FIGS. 6A, 6B, and 7). An AC power supply
(not shown) supplies electrical power to the CPU 126, PPU 60, and
other electrical components of the device 18.
[0047] The CPU 126 is coupled via a USB, RS-232, or Ethernet port,
or other connective means, to the MPU 58 (see FIG. 13). The CPU 126
receives high-level instructions from the MPU 58 generated by the
compounding control manager 72. The PPU 60 (see FIG. 13) is coupled
via an RS-232 link to the CPU 126. The high-level instructions
generated by the compounding control manager 72 are conveyed by the
CPU 126 as medium level commands to the PPU 60. The PPU 60 is
connected to various hardware of the peristaltic pump station 50
and weigh station 26--e.g., the door interlock 66 (as previously
described), a pump motor 64 (see also FIG. 6A, as will be described
later), pump clutches 68 (a will be described later), Hall effect
pump rotor sensors 70 (as will also be described later), the load
cell 30 (previously described), etc. The PPU 60 provides
hardware-specific commands, based upon the medium level control
commands generated by the CPU 126, as well as a first level of
safeguards (e.g., to stop the pump motor 64 if the door 56 is open,
as previously described). The PPU 60 and CPU 126 communicate with
and monitor each other, to backup individual failures and take
corrective action.
[0048] The compounding control manager 72 function 72 resides on
the MPU 58. The compounding control manager 72 includes
preprogrammed rules that prescribe procedures for receiving and
manipulating input data, monitoring device status and operating
conditions, outputting or storing data, and commanding operation of
the peristaltic pump station 50 to achieve prescribed compounding
tasks. The MPU 58 communicates high level instructions to the CPU
126 (e.g., the amount of liquid each peristaltic pump assembly 54
is to convey), which are created by the compounding control manager
72 in response to operator input. The CPU 126, in turn,
communicates medium level instructions to the PPU 60, which
communicates specific pump commands to the peristaltic pump
assemblies 54 to carry out the pumping instructions, well as
receives and evaluates operational status data from sensors and the
load cell, to generate closed-loop feedback control and
corresponding alarms. The PPU 60 also relays operational status
data to the CPU 126, which also evaluates the operational status
data in parallel with the PPU 60. In this respect, the CPU 126
provides a second level of safeguards if an alarm condition is not
detected by the PPU 60 (e.g., to halt pumping if over-delivery--not
otherwise sensed by the PPU 60--is occurring).
[0049] In the illustrated embodiment (see FIG. 1), the controller
20 includes a display device 76, which is part of the control panel
24, data entry devices 78 (e.g., a keyboard and a mouse), and a
data output station 80 (e.g., a printer), which are coupled via
appropriate inputs and outputs to the MPU 58. In the illustrated
embodiment (see FIG. 1), the display device 76 also desirably
serves as another data entry device using, e.g., conventional touch
screen methodologies implemented by the compounding control manager
72 using a Windows.RTM.-based operating platform resident in the
compounding control manager 72. The combined data display and data
entry capabilities that the compounding control manager 72 executes
in this arrangement provide an interactive user interface on the
display device 76 that, under preprogrammed rules resident in the
compounding control manager 72, accepts data entry and displays for
the operator information prompting or confirming the entered data,
as well as monitored operational status and conditions of the
compounding device 18. The compounding control manager 72 also
provides a third level of safeguards by verification of the
original order with the actual pump delivery results. The display
can be in alpha-numeric format and/or as graphical or pictorial
images, as desired. The compounding control manager 72 also enables
output of selected information to the printer 80 in a desired
format, e.g., as activity reports. The interactive user interface
of the compounding control manager 72 allows the operator to
conveniently enter, view, and assimilate information regarding the
operation of the system 10. Further details of the compounding
control manager 72 and the touch screen interactive user interface
that can be implemented by the compounding control manager 72 will
be described later.
[0050] As also shown in FIG. 1, the MPU 58 also includes an input
for a bar code reader 82 or the like, for scanning information into
the compounding control manager 72. Further details of this aspect
of the system 10 will be described later.
[0051] As FIG. 1 also shows, the MPU 58 also includes input for
keyboard and mouse data entry devices 78. These devices 78 allow
the operator to enter data for manipulation by the compounding
control manager 72 and to interact with information presented by
the display device 76 in different ways, and without use of the
touch screen data entry capabilities of the compounding control
manager 72. In this arrangement (see FIG. 13), the controller 20
desirably includes an order entry process manager 84, which can
reside on the memory device 74 of the MPU 58 in the control panel
24. The order entry manager 84 makes possible other forms of
interactive data entry and data viewing platforms, as well as other
forms of data output to the printer 80 in a selected format, e.g.,
as labeling for the final solution container 14, as will be
described in greater detail later.
[0052] Desirably (as FIG. 13 shows), the order entry process
manager 84 can be accessed by browser software 86 residing on one
or more external microprocessors 88 linked to the compounding
control manager 72 of the device controller 20. In this
arrangement, the controller 20 desirably includes an RS-232 link or
another alternative data communication connections (e.g., radio,
microwave, infrared, or other electromagnetic wave communication
systems), to enable electronic or electromagnetic data
communication between the compounding control manager 72 and
external input or output devices (e.g., other data entry
workstations and/or printers), using, e.g., single-station hubless
local area network connections, multiple-station hub or switch
local area network connections, multiple-station hub connections
with facility network servers, and/or multiple-station connections
through the public internet. Conversely, or in addition, multiple
compounding devices 18 can be linked through their onboard
controllers to multiple data entry workstations or sites. These
capabilities of the controller 20 make diverse arrangements of
fully networked pharmaceutical compounding possible. Further
details of these networked forms (e.g., internet, intranet, or
loopback) of interactive data entry and data viewing platforms,
that can be accommodated by the controller 20 in association with
the compounding control manager 72, will be described later.
[0053] Upon completing a compounding procedure, the operator seals
the inlet tubing 40 of the final solution container 14 and detaches
the final transfer tubing spike 42 from the manifold 36. When there
are a series of compounding orders that require mixtures of at
least some of the same source solutions, which typically is the
case, the operator will proceed to the next compounding order by
attaching the spike 42 of the inlet tubing 40 of a new final
solution container 14 to the manifold 36 and executing another
compounding procedure. Otherwise, the operator can decouple the
source transfer tubing 34 from the source containers 16 and remove
the transfer set 12 and source containers 16 from association with
the device 18. The transfer set 12 can be discarded. Each final
solution container 14, and its compounded liquid contents, is
retained for storage, infusion, transfusion, or further
processing.
II. Technical Features of the Compounding Device
[0054] FIGS. 6A, 6B, and 7 best show the details of construction of
a representative embodiment of the compounding device 18. As
illustrated, the device 18 includes a frame 90 that is divided into
the pump bay 52 and the electronics bay 62, as previously
described. Hardware components of the peristaltic pumping station
50 occupy the pump bay 52. The electrical components of the pumping
station 50 and the load cell 30, as well as the PPU 60, occupy the
electronics bay 62. The case 22 shown, e.g., in FIGS. 4 and 5,
encloses the frame 90 and the components it carries.
[0055] A. The Peristaltic Pumping Station
[0056] Within the pump bay 52, the peristaltic pumping station 50
includes an array of peristaltic pump rotor assemblies 54, as
already generally described. The number and configuration of
peristaltic pump rotor assemblies 54 can vary according to design
considerations and the compounding requirements of the device 18.
In the illustrated embodiment (shown in FIG. 4), there are nine
peristaltic pump rotor assemblies 54.
[0057] As illustrated (see FIGS. 6A and 6B), each peristaltic pump
rotor assembly 54 is constructed in the same manner. Each assembly
54 is supported on a bearing plate 92 secured to the frame 90. The
bearing plates 92 are arranged sequentially in an axial spaced
relationship along a drive shaft 94. The drive shaft 94 is coupled
at one end to the electric drive motor 64 (see FIG. 6A) (carried in
the electronics bay 62) via a drive belt 96 and drive pulley 98.
Alternatively, the drive shaft 94 can be coupled directly to the
drive motor 64. Operation of the drive motor 64, which is governed
by the controller 20, rotates the drive shaft 94 at a desired rate
of rotation. In a representative implementation, the drive motor
can rotate the drive shaft 94 at variable rates. Each pump rotor
assembly 54 includes a drive gear 100, which is carried by a
bearing 102 on the drive shaft 94. A conventional electro-magnetic
clutch assembly 68 is coupled to each drive gear 100. Each clutch
assembly 68 is individually coupled to the controller 20 (as FIG.
13 shows). When actuated by the controller 20, a given clutch
assembly 68 frictionally couples the drive gear 100 to the drive
shaft 94, causing rotation of the drive gear 100. When the clutch
assembly 68 is not actuated by the controller 20, rotation of the
drive shaft 94 is not imparted to the associated drive gear
100.
[0058] A fixed idler shaft 104 extends through the bearing plates
92, spaced from and offset from the drive shaft 94. Each pump rotor
assembly 54 also includes a driven gear 106 carried on a bushing
108 on the idler shaft 104. The driven gears 106 are individually
coupled to the drive gears 100, such that rotation of a given drive
gear 100 will impart rotation to its respective driven gear 106. In
this arrangement, each pump rotor assembly 54 includes a pump rotor
110 coupled (e.g., by gear attachment screws 112) for rotation with
each driven gear 106. Each pump rotor 110 carries an array of pump
rollers 114, which, in use, engage an in-line pump segment 46 of
the transfer tubing 34.
[0059] Actuation of a given clutch assembly 68 by the controller 20
couples the associated drive gear 100 to the drive shaft 94--to
which rotation is imparted by the drive motor 64--which, in turns,
imparts rotation through the driven gear 106 to the associated pump
rotor 110. During rotation of the pump rotor 110, the pump rollers
114 engage the associated pump segment 46 and convey liquid through
the transfer tubing 34 by well-understood peristaltic pumping
action.
[0060] Each pump rotor assembly 54 includes a pair of holding
brackets 116 aligned with the associated pump rotor 110. The
holding brackets 116 are sized and configured to releasably mate
with mounts 118 (see FIG. 2A) formed on opposite ends of each pump
segment 46. The holding brackets 116 frictionally engage the pump
segment mounts 118, and thereby hold the pump segments 46 in
desired operative association with the pump rollers 114 during use,
as FIG. 5 shows.
[0061] As will be described in greater detail later, the holding
brackets 116 of the pump rotor assemblies 54 and pump segment
mounts 118 of the transfer tubing 34 are desirably uniquely coded
(e.g., by matching numbers and/or by a matching color or the like)
to prompt a desired order to the mounting of a selected pump
segment 46 in relation to a selected pump rotor 110. The unique
matching code is also carried by the spike 38 of the associated
transfer tubing 34 (e.g., by a numbered, colored tab 120), to
prompt a desired coupling of the transfer tubing 34 in relation to
a selected source container 16. As will be described in greater
detail later, the graphics of the user interface generated by the
compounding control manager 72 desirably incorporates this unique
code, thereby matching the disposable components of the transfer
set 12 with the hardware components of the pump station 50, as well
as with the desired software functionality provided by the
compounding control manager 72.
[0062] Desirably, the unique matching code includes bar-code
indicia, e.g., one or two-dimensional bar code. In this
arrangement, the compounding control manager 72 can require the
operator to perform the physical act of scanning in bar code
indicia on a solution container and on the transfer set, to
eliminate potential error sources prior to compounding. This
marriage between software, hardware, and disposable components
minimizes sources of compounding errors due to human error.
[0063] As shown in FIG. 2F, the transfer set 12 can also include a
tubing organizer 128, which comprises a molded or fabricated strip
of plastic sized and configured to capture, as a unit, all the
transfer tubing 34 between the pump segments 46 and the spikes 38
in a desired order. In this arrangement, the organizer 128 requires
the operator to mount the pump segments 46 as a unit to the holding
brackets 116, with the order of the transfer tubing 24 with respect
to the pump rotor assemblies 54 preordained by the organizer 128.
The organizer 128 further assures that the transfer tubing 34 is
loaded in a desired order on the compounding device 18.
[0064] The system 10 makes possible systematic process control at
every stage of the compounding process, starting at the physician
order point and continuing through compounding and final product
delivery and receipt. As above described, orders can be received
from the patient site via hospital based electric ordering systems.
Upon the electronic receipt of data, such data can be entered or
transmitted electronically into the compounding control manager 72.
Final solution containers 14 can be labeled automatically as the
step preceding the compounding process. The compounding process can
thereafter be controlled and verified through labeling on the final
solution container 14 in combination with source container labeling
and bar coding.
[0065] B. Pump Control Criteria
[0066] As has been generally described, and as will be described
later in greater detail, a desired compounding order is entered by
an operator, and the compounding control manager 72 in the MPU 58
of the control panel 24 executes the compounding order. Typically,
the compounding order identifies the source solutions and the
amounts of each source solution (by weight or volume) that are to
be mixed in the final solution. The compounding control manager 72
can operate the individual pump rotor assemblies 54 (through the
PPU 60 in the compounding device 18) in a serial compounding mode,
i.e., operating a first pump rotor assembly 54 to convey the
desired amount of a first source solution into the final container
14, then next operating a second pump rotor assembly 54 to convey
the desired amount of a second source solution into the final
container 14, and so on until the desired amount of each source
solution has been delivered to comprise the desired mixture.
[0067] In controlling the individual pump rotor assemblies 54, the
preprogrammed rules of the compounding control manager 72 desirably
take into account pre-established delivery accuracy criteria. The
criteria can vary according to the compounding tasks to be
accomplished. For example, for TPN, delivery accuracy criteria can
be established of +/-5%, or better, for any ingredient of 0.2 mL or
more. A delivery accuracy criteria of +5%/-0% could be established
to eliminate the possibility of underfills.
[0068] The preprogrammed rules of the compounding control manager
72 also desirably include a delivery time criteria that takes into
account the delivery volume. Keeping absolute errors as small as
possible is mandated at smaller delivery volumes to achieve a
system delivery accuracy goal of +/-5% or better. Such smaller
absolute delivery errors require the compounding control manager 72
to incorporate tighter process control, which, for smaller delivery
volumes, can result in longer delivery times per mL of delivery.
However, larger absolute errors are acceptable at larger delivery
volumes to achieve a system delivery accuracy goal of +/-5% or
better. For example, a 1% error on a 10 mL delivery is 0.1 mL. The
same 1% error on a 1000 mL delivery is 10 mL. Thus, the compounding
control manager 72 can institute different process control for
larger volumes, which, for larger delivery volumes, can result in a
faster delivery times per mL of delivery.
[0069] The compounding control manager 72 can also accommodate
parallel processing of the same source solution. For example, if
the same source solution is present on two pump rotor assemblies
54, both source solutions can be pumped in parallel (at the same
time) to shorten overall delivery time. Thus, if it takes two
minutes to fill a single container using serial compounding (i.e.,
one solution after the other), it is expected that parallel
compounding can potentially reduce this time requirement down to
one minute, depending upon the solution components that comprise
the final product.
[0070] The preprogrammed rules of the compounding control manager
72 institute desirable closed-loop control of the pump drive motor
64. The close-loop control desirably implement convention
proportional-integral-derivative (PID) control schemes to control
pump speed to achieve a desired target delivery. The PID control
schemes generate pump correction commands that take into account
not only the absolute difference between the present delivery
amount and the target amount, but also the how quickly the absolute
difference is changing over time. The control schemes can use a
purely mathematical PID model, or they can incorporate "fuzzy
logic" techniques, making use of estimations and interpolations to
determine how to adjust the motor speed to obtain the desired flow
rate. Use of fuzzy logic techniques permit a motor speed control
function without use of multiply and divide instructions, thereby
minimizing processing complexity.
[0071] In one representative implementation, the compounding
control manager 72 conducts a high speed flow rate control regime
until the absolute difference between the volume delivered and the
target approaches a preset amount. At this "slow down" point, the
compounding control manager 72 ramp-downs the flow rate and
conducts a low speed flow rate control regime. During this regime,
the correction commands become successively smaller as the
difference between the volume delivered and the target diminishes.
The rate of the flow rate reduction during this regime can be
linear or non-linear, and the slope of the non-linear reduction can
be either concave, or convex, or a combination thereof.
[0072] In a desired implementation, the compounding control manager
72 steps or pulses the respective pump rotor assembly as the target
volume is approached. In this arrangement, the PPU 60 can
communicate with rotor rotation sensors 70, so that a rotor
revolution can be correlated with a number of incrementally sensed
steps, which, in turn, can be correlated with incremental degrees
of rotor rotation--e.g., one full revolution (360 degrees) equals
five hundred incrementally sensed steps, so each incrementally
sensed step equals 0.72 degrees of rotation. In this way, the PPU
60 can generate very precise pump commands in terms of small
incremental units of pump rotor rotation when the target volume is
approached, to prevent an overfill.
III. Technical Features of the Transfer Set
[0073] As before described, for a typical compounding session,
there are usually a series of compounding orders that require
mixtures of at least some of the same source solutions. In this
arrangement, an operator will repeatedly exchange final solution
containers 14 with the same manifold 36.
[0074] In these circumstances, a compounding order that requires a
fat emulsion as a source solution can leave a fat emulsion residue
in the manifold 36. This residue left in the manifold 36, although
small in volume, can be introduced into the final solution
container 14 of a subsequent compounding order, which may not
specify a fat emulsion. The unintended residue causes what is
generally called "lipid hazing" in the final solution container 14
of a compounding order that is supposed to be free of a fat
emulsion.
[0075] To minimize the lipid hazing effect, in FIG. 2B, there is
one transfer tubing 34' that is intended, during use, to be
dedicated to the conveyance of a fat emulsion. As before explained,
a unique coding arrangement, coupled with required bar code
scanning, can be incorporated to assure that this transfer tubing
34' is dedicated during use to the conveyance of fat emulsion from
a source container. During compounding, fat emulsion is conveyed
into the final solution container 14 in advance of the other source
solutions. Thus, the compounding of other source solutions after
the fat emulsion serves to flush residual fat emulsion from the
manifold 36 and into the final solution container 14.
[0076] Following compounding, when the spike 42 is withdrawn from
the outlet 44, a temporary vacuum is created within the manifold
36. The valves 48 can open in response to the temporary vacuum
created by withdrawal of the spike 42 from the outlet 44, drawing a
small bolus of source solutions into the manifold 36. A residue of
fat emulsion can be included in this bolus.
[0077] In the illustrated arrangement, the valve 48' in the
manifold 36 that is in-line with the fat emulsion transfer tubing
34' is sized and configured to have a valve opening or "cracking"
pressure that is greater than the valve opening or cracking
pressure of the other valves 48 in the manifold 36, which are
in-line with transfer tubing 34 that is not coupled to a fat
emulsion source container. The greater cracking pressure of the
valve 48' that is in-line with the fat emulsion transfer tubing 34'
is selected to keep the valve 48' closed when the spike 42 is
withdrawn from the outlet 44.
[0078] In use (as FIG. 2C shows), when a spike 42 is withdrawn from
the outlet 44, due to the lesser cracking pressures of the valves
48 that are not in-line with the fat emulsion transfer tubing 34',
these valves 48 can open in response to the temporary vacuum
created by withdrawal of the spike 42 from the outlet 44. However,
due to the greater cracking pressure of the valve 48' that is
in-line with the fat emulsion transfer tubing 34', the valve 48'
remains closed when the spike 42 is withdrawn from the outlet 44.
Thus, as the spike 42 is withdrawn and the temporary vacuum is
created within the manifold 36, the small bolus of source solutions
from all the source containers that may be drawn into the manifold
36 will not include the fat emulsion. Thus, a residue of fat
emulsion is prevented from entering the manifold 36 when the final
solution container 14 is exchanged.
[0079] In an alternative arrangement (see FIGS. 2D and 2E), the
peristaltic pump rotor assembly 54' serving the one transfer tubing
34' dedicated to the conveyance of fat emulsion can be capable of
reverse rotation under the direction of the controller 20. Reverse
rotation creates a negative pressure and draws the in-line valve
48' closed. In this arrangement, the controller 20 commands reverse
rotation of the fat emulsion pump assembly 54' prior to the
operator removing the spike 42 from the outlet 44. As FIG. 2E
shows, removal of the spike 42 can open the valves 48, except the
valve 48' in the fat emulsion tubing 34', which remains closed due
to the counterforce of negative pump pressure. As before described,
as the spike 42 is removed, a bolus of source solutions from all
the source containers can be drawn into the manifold 36, except for
the fat emulsion.
[0080] The vacuum created by removal of the spike 42 can be
augmented by pulsing the other peristaltic pump rotor assemblies 54
in a forward direction as the spike 42 is withdrawn. In this
arrangement, the cracking pressure of the valve 48' serving the fat
emulsion transfer tubing 34' need not be different that the
cracking pressure of the other valves 48.
IV. Technical Features of the Controller
[0081] A. The Compounding Control Manager
[0082] The compounding control manager 72 resides in the MPU 58 in
the control panel 24. The compounding control manager 72 allows a
clinician to enter, view, adjust and offload information pertaining
to a given compounding protocol.
[0083] In general, the compounding control manager 72 is the
program language that provides the operator with real time feedback
and interaction with the compounding device through graphic user
interface (GUI) elements. The GUI elements, created in a
Windows.RTM.-based graphical format, display the various inputs and
outputs generated by the compounding control manager 72 and allow
the user to input and adjust the information used by the
compounding control manager 72 to operate the compounding device
18.
[0084] To develop the GUI elements, the compounding control manager
72 can utilize certain third party, off-the-shelf components and
tools. Once developed, the compounding control manager 72 can
reside as a standard window-based software program on a memory
device.
[0085] FIGS. 9A to 9W are a walk-through of display screens
generated by a representative embodiment of the compounding control
manager 72, which demonstrate various features of the compounding
control manager 72.
[0086] After an initial start-up mode of software initialization, a
main work area is created on the display device 76, which initially
opens a log-in screen 200 (FIG. 9A). The log-in screen 200 prompts
the operator to identify themself, either by using the bar code
scanner to scan an operator badge number, or by entry of a badge
number or other selected form of identification on the graphical
touch screen entry pad. This identification procedure is required
for logging-in and/or assessing the operator's level of security
clearance. Desirably, a system administrator would have previously
established a list of authorized users, against which the sign-in
data is compared.
[0087] Once an authorized identification is entered, the log-in
screen 200 is replaced by a main screen 202 (FIG. 9B). The main
screen 202 displays sequentially numbered pump station data fields
204 204. The pump station data fields 204 are desirably numbered
according to the left to right placement of the peristaltic pump
rotor assemblies 54 in the compounding device. The numbers are also
desirably color-coded according to the color code assigned to the
peristaltic pump rotor assemblies 54 in the compounding device 18,
as previously described.
[0088] Each pump station data field 204 includes a solution field
206 for the operator to identify what solution is to be delivered,
as well as an amount field 208 to identify how much of that
solution is to be delivered. The solution field 206 includes a
touch button 210 that prompts TOUCH TO PROGRAM STATION. Touching
the prompt button 210 allows to operator to enter data in the
solution and amount fields 206 and 208 required by the compounding
control manager 72.
[0089] Touching the prompt button 210 first opens a solution
programming box 212 (FIG. 9C) The solution programming box 212
displays within the main screen 202 an array of touch buttons that
either contain a specific identification of a solution type--e.g.,
DEX (dextrose); AMINO (amino acid); LIPID (fat emulsion); LYTES
(electrolytes)--or allow the operator to specify another solution
type (OTHER), or ask for a list of available solutions (LIST).
Desirably, a system administrator would have previously established
a list of solutions, using the OPTIONS MENU touch button 214 on the
main screen 202, as will be described later. Other touch buttons in
the solution programming box allow the operator to scroll through a
list of solutions (PREVIOUS SOLUTION, NEXT SOLUTION). Another
button (OK) allows for a verification of the identified solution
and entry of that solution in the solution field 206, or an exit
button (CANCEL) that closes the solution programming box 212 with
no data entry in the solution field 206. Selection of a specific
solution type button (e.g., DEX) (see FIG. 9D) either enters the
only solution of its type on the list (i.e., Dextrose 70%), or, if
there are various selections to be made (e.g., by selecting AMINO),
displays a solution listing box 216 for that solution type (see
FIG. 9E), from which the operator selects by touch.
[0090] Once the solution type has been selected, the operator
selects the OK button on the solution programming box 212, and the
solution type appears (see FIG. 9F) in the solution field 206 of
the pump station data field 204. An amount programming box 218 is
also opened (FIG. 9F), which replaces the solution programming box
212. The amount programming box 218 comprises a graphical numeric
keypad, by which the operator can enter an amount expressed in a
selected unit which is to be transferred by the selected pump
station from the source solution container into the final container
(e.g., volume, expressed in mL). The unit for the amount can also
be specified by use of the DOSE CALCULATOR touch button 220. Once
the numeric amount is entered, pressing the ENTER touch button in
the amount programming box 218 enters the entered amount in the
amount field 208 of the pump station data field 204 (see FIG. 9F),
and the amount programming box 218 closes.
[0091] The station control box 222 (FIG. 9G) can also be optionally
selected by pressing the station number identification icon 224.
The station control box 222 requires that the transfer of the
solution identified in the solution field 206 be confirmed by the
operator pressing the CONFIRM SOLUTION touch button 226. Pressing
the CONFIRM SOLUTION touch button 226 opens a solution confirmation
box 228 (FIG. 9H). The operator is prompted to scan a bar code on
the source solution container (using the bar scanner input device
82). This bar code identifies, e.g., the solution type, the lot
number of the solution, and its expiration date. By scanning the
bar code, the compounding control manager 72 links this information
to a specific compounding order for verification and solution
tracking purposes. Furthermore, the compounding control manager 72
can implement expiration date control, locking out the use of
expired solutions. The integration of the bar code scanning
function with the compounding control manager 72 integrates lot
number and expiration date tracking and/or verification to the
operation of the compounding device 18.
[0092] The operator is also prompted to visually assure that the
transfer tubing 34 having the unique coding corresponding to the
pump station number is coupled to the source container from which
the bar code is scanned, as well as scan the bar code component of
the unique code on the transfer tubing 24 for that pump station. As
confirmation of the correct source solution container 15 and
transfer tubing 24 is made by the operator by scanning bar codes,
information in the solution confirmation box 228 is updated (see
FIG. 9I). After full confirmation is accomplished, the operator can
press an OK touch button in the solution confirmation box 228.
[0093] The solution flush box 230 (see FIG. 9J) can also be
optionally selected by pressing the FLUSH station control button on
the station control box 222 (see FIG. 9G). The solution flush box
230 includes touch buttons that prompt the operator to conduct a
SHORT FLUSH (e.g., 2 seconds) or a LONG FLUSH (e.g., 5 seconds),
during which time the compounding control manager 72 operates the
corresponding peristaltic pump rotor assembly 54 for the selected
pump station. The load cell 30 monitors for weight changes,
indicating entry of solution into the final container 14, to verify
(if desired) that flow communication exists between the source
solution container 16 and the final container 14. The solution
flush box 230 indicates completion of the flush (see FIG. 9K), and
the operator is prompted to by an EXIT touch button to return to
the main screen 202. Flush is not required prior to the start of
compounding, but is available as an optional set up step.
[0094] The operator is prompted to follow the above prescribed
sequence for each source solution and each pump station, until
programming is complete. FIG. 9L shows the main screen 202 after
(i) the operator has programmed the compounding control manager 72
to mix 137 mL of 70% dextrose (pump station 1), 54 mL of 15%
novamine (pump station 2), 77 mL of 10% Travasol (pump station 3),
and 216 mL of sterile water (pump station 9) from source solution
containers into the final container, and (ii) the operator has also
verified for each pump station that the proper source solution and
transfer tubing set up are present. As FIG. 9L shows, the main
screen 202 lists the solutions and amounts in the respective fields
206 and 208 of each pump station box 204 and, further, prompts the
operator to press a highlighted START touch button 232. Upon
selection of the START touch button, compounding immediately
commences under the control of the compounding control manager 72.
If one or more of the source solutions have not been confirmed at
the time the operator presses the START button 232, the compounding
control manager 72 will automatically prompt the operator to
confirm each remaining source solution before compounding is
allowed to begin. The START touch button 232 is not enabled by the
compounding control manager 72 until all required preliminary steps
have been satisfactorily completed.
[0095] Alternatively, the operator can select an AUTO PGM touch
button 232 on the main screen 202 (see FIG. 9L). This opens a queue
selection screen 236 (FIG. 9P), which displays a list of
preprogrammed schedule queues established by the system
administrator. The operator selects the desired queue and presses
the ENTER touch button on the queue selection screen 336. The
compounding control manager 72 holds the order queue list in
memory, and the main screen 202 (see FIG. 9Q) allows the operator
to view the current order queue list, one order at a time, in a
queue box 238. In this arrangement, the operator selects the order
from the programmed order queue list on the main screen 202, and
then starts compounding. Alternatively, the operator can scan a bar
code on a final solution container to be compounded. The
compounding control manager 72 uploads and presents the compounding
order for that final container.
[0096] As compounding proceeds, the compounding control manager 72
updates the number TOTAL DELIVERED field 240 (by incrementing up)
and amount field 208 (by incrementing up) of the respective pump
station field 204 of the main screen 202 (FIG. 9M), to indicate the
series transfer of liquid from the several source containers 16
into the final container 14. In FIG. 9M, pump stations 1, 2, and 3
have been programmed. Station 1 has completed its pumping (having
delivered the desired 138 mL. Station 3 has begun to pump (having
pumped 38 mL). Station 9 is waiting to begin. The TOTAL DELIVERED
field 240 shows 176 mL, which is the current sum of amounts pumped
by pump stations 1, 2, and 3. The PUMPING icon 242 is illuminated
to indicate that compounding is proceeding. The operator can, if
desired, terminate compounding by pressing the illuminated STOP
touch button 244.
[0097] If, during the course of compounding, the load cell 30
indicates that there is no liquid transfer into the final container
14, the compounding control manager 72 generates a pumping alarm.
The compounding control manager 72 interrupts the compounding
procedure when this alarm condition occurs. The compounding control
manager 72 opens a pumping alarm screen 246 (FIG. 9N). The
INTERRUPTED icon 248 is also illuminated to indicate that
compounding is not proceeding. An information field 250 displays
information pertaining to the alarm condition. The information
field 250 prompts the operator to take corrective action and, by
pressing a RESUME touch button 252, to commence compounding once
again.
[0098] When compounding is complete, the compounding control
manager 72 displays a COMPLETE message in the information field 250
(see FIG. 9O) and prompts the operator to remove the final
container 14.
[0099] The operator can then reprogram the compounding control
manager 72 to carry out another compounding regime by following the
above sequences of steps.
[0100] There are other graphical buttons on the main screen 202
(see FIG. 9A), which may be used to carry out various support
functions. For example, by pressing the OPTIONS MENU touch button
214, the options menu screen (FIG. 9R) is displayed. The option
menu screen prompts the operator to select among a list of
administrative functions that, in the illustrated embodiment,
include REPEAT LAST ORDER, ORDER HISTORY, SETTINGS AND DIAGNOSTICS,
and SIGN OFF. Pressing the REPEAT LAST ORDER button automatically
configures the compounding control manger to compound according to
the most recent order. Pressing the ORDER HISTORY button displays
an order history screen (FIG. 9S), that lists the compounding
orders that have been executed -by the compounding control manager
72. These compounding orders are maintained in memory by the
compounding control manager 72. Pressing the SETTINGS AND
DIAGNOSTICS button displays the settings and diagnostic screen 260
(FIG. 9T) that displays additional administrative functions that
the system administrator can perform, such as establishing the list
of available source solutions for the solution programming box 212
(FIGS. 9D and 9E), previously discussed. Other additional
administrative functions can also be accessed through this screen.
Pressing the SIGN OFF button displays a fresh log-in screen, and
the compounding control manager 72 awaits a new order sequence from
an operator.
[0101] In the illustrated embodiment, the main screen 202 also
includes a CALIBRATE SCALE touch button 262 (see FIG. 9A). When
pressed, the button 262 opens an instruction screen (FIG. 9W), that
leads the operator through a sequence of steps that calibrate the
load cell.
[0102] Also displayed on the main screen 202 is a HELP icon 264
(identified by a question mark--?). Pressing the HELP icon 264 on
the main screen 202 opens a main screen help screen 266 (FIG. 9U),
which displays a list of available help topics pertaining to the
compounding control manager 72 and operation of the compounding
device 18 in general. Desirably, a HELP icon 264 is also present on
every other functional screen or box generated by the compounding
control manager 72 (see, e.g., FIGS. 9A, 9E, 9H, 9P). Pressing the
HELP icon 264 on any given screen opens a context sensitive help
screen, which provides guidance pertaining to the particular
function that the given screen performs. For example, FIG. 9V shows
a context sensitive help screen 268 that opens when the HELP icon
264 on the pump alarm screen 246 (FIG. 9N) is pressed. As can be
seen, the context specific help topic is NO SOLUTION FLOW ALARM,
and the screen provides instructions for correcting the alarm
condition.
[0103] In a desired implementation, the compounding control manager
72 incorporates within its preprogrammed structure an integrated
selection of training and/or help video files, e.g., in MPEG
format. The integrated training and/or help video files contain
formatted pre-taped video footage and streaming audio. When
presented by the compounding control manager 72 on the display
screen 76, the files communicate information to the operator in a
direct visual and audible way. This platform of communication,
which forms an integrated part of the compounding control manager
72, provides the operator direct, real time access to context
specific information in an effective, first person, visual and
audible format, eliminating the need to resort to offline training
manuals or separate CD's.
[0104] In a representative implementation, pressing the HELP icon
264 on the main screen 202 opens a main screen video training/help
screen 270 (FIG. 14A). The screen 270 displays a list of available
training/help topics pertaining to the compounding control manager
72 and operation of the compounding device 18 in general. The
screen incorporates 270 a MPEG viewing area 272, in which the
training and/or help video files in the compounding control manager
72 are displayed. Selecting an instruction/help topic runs the
associated MPEG file.
[0105] As an example, FIGS. 14B(1) to 14B(8) show representative
screen captures from a training/help video for "Programming the
Compounder." The training/help video, with associated streaming
sound file, walk an operator through the steps of entering a
compounding order using the graphical user interface of the
compounding control manager 72. These steps have been previously
described, with reference to FIGS. 9B to 9F. The training/help
video explain that the first step is to identify the source
solution (FIG. 14B(2), and then proceed (FIG. 14B(3), by visual and
audible instructions, the procedure for using the Solution
Programming Box 212 (previously described in the context of FIGS.
9C and 9D). The training/help video then explain that the next step
is to determine the solution volume (FIG. 14B(4), and then proceed
(FIGS. 14B(5)to 14B(7), by visual and audible instructions, the
procedure for using the Amount Programming Box 218 (previously
described in the context of FIG. 9F). The training/help video
concludes (FIG. 14B(8)) by congratulating the operator for
successfully accomplishing the programming procedure.
[0106] As can by now be appreciated, the compounding control
manager 72 serves to generate an interactive user interface that
presents as much information/control on one screen as possible
without making the screen too busy. Among its features are (i) to
minimize user entry errors by making their entry points very
focused and utilizing large display and keypad areas; (ii) to
minimize keystrokes for the experienced user; (iii) to provide as
much help as possible for the inexperienced user; and (iv) to
minimize calls to service by making "smart help" available.
[0107] The compounding control manager 72 makes possible the
operation of a gravimetric compounding device 18 under direct
software process control, while utilizing bar-codes as a process
quality control mechanism.
[0108] B. The Order Entry Process Manager
[0109] The order entry process manager 84 can be installed on the
MPU 58 of the controller 20 and/or on another workstation linked to
the controller 20. The order entry process manager 84 provides an
array of enhanced order entry functions for the compounding control
manager 72. The order entry process manager 84 also provides an
information management function and label printing function, that
make possible simplified and consolidated order data record storage
and control on a patient-by-patient basis. This function is
integrated with the communication of the order data to the
compounding control manager 72 of a compounding device 18, to
thereby facilitate set-up, operation, and management of an overall
compounding system in a reliable fashion that minimizes error. The
order entry process manager 84 makes possible a centralized or
distributed order data entry, order data storage, order data
manipulation, and order data communication system.
[0110] The order entry process manager 84 desirably receives data
input through keyboard/mouse devices 78, and provides data output
either through the display screen 76 of the control panel 24 (as
shown in FIG. 8A), or a separate, dedicated display device 300 (as
shown in FIGS. 8B to 8F). The order entry process manager 84 also
is desirably linked to a printer 302, for providing reports and
labeling in paper form.
[0111] The order entry process manager 84 can be developed to
generate its own proprietary user interface (like the compounding
control manager 72). Desirably, however, the order entry process
manager 84 is developed in a graphics-based environment (e.g.,
Windows.RTM., Linux.RTM., etc.) using, e.g., an Apache.RTM. or
Java.RTM. Operating Environment that can be used in association
with conventional web-server or browser software 86, such as
Microsoft.RTM. Internet Explorer, Netscape.RTM. Navigator, or an
equivalent public accessible browser. In this arrangement, the
order entry process manager 84 desirably comprises the program
language that provides the operator with real time feedback and
interaction with the controller 20 of the compounding device
through browser-based graphic user interface (GUI) elements. The
browser-based GUI elements allow an operator to input and adjust
the information used by the compounding control manager 72 to
operate the compounding device. This makes possible the linkage of
the proprietary compounding control manager 72 of the compounding
device to one, several, or an entire network of conventional
browser data entry and output platforms, which can comprise a
single local site or a network of remote sites. Implemented in this
manner, the order entry process manager 84 and browser software 86
make fully networked compounding possible. Furthermore, the order
entry process manager 84 makes possible a network appliance
function, whereby all an authorized operator has to do is couple a
browser to the MPU 58 of the compounding device 18 to be able to
control the compounding device 18. The network appliance function
significantly enhances the usability and flexibility of the
compounding device 18.
[0112] To develop the browser-based GUI elements, the order entry
process manager 84 utilizes certain third party, off-the-shelf
components and tools, available in e.g., Apache.RTM. or Java.RTM.
Operating Environments. Once developed, the order entry process
manager 84 can reside as a software program on a memory device. The
order entry process manager 84 can be accessed by a laptop or
desktop workstation computer, PDA device, or any other device that
can run a browser, to provide different order entry platforms.
[0113] C. Associations with the Compounding Control Manager
[0114] The order entry process manager 84 and browser software 86
accommodate diversely different associations with the compounding
control manager 72 installed on the controller 20 of the
compounding device 18.
[0115] In a basic form (see FIG. 8A), the order entry process
manager 84 and browser software can be installed in the MPU 58 in
the control panel 24 of the compounding device 18, to constitute a
single control panel configuration. In this arrangement, the
display device 76 on the control panel 24 supports the
browser-based interface of the order entry process manager 84 for
order entry to the compounding device and label printing, as well
as supporting the proprietary touch screen interface of the
compounding control manager 72 during operation of the compounding
device.
[0116] In another arrangement (see FIG. 8B), the browser software
86 can be installed on a data entry workstation 304 positioned in
the same facility as the compounding device 18. The data entry
workstation 304 can be placed near the compounding device 18, or it
can be physically separated from the compounding device within the
facility. In this arrangement, the browser software 86 of the data
entry workstation 304 is linked, e.g., via a hubless local area
network connection to the order entry process manager 84 residing
in the MPU 58 in the control panel 24 of the compounding device 18,
to constitute a single data entry station configuration. In this
arrangement, the display device 300 of the data entry workstation
304 supports the browser-based interface of the order entry process
manager 84 for order entry to the compounding device and label
printing. The display device 76 of the control panel 24 supports
the proprietary touch screen interface of the compounding control
manager 72 during operation of the compounding device 18.
[0117] In another arrangement (see FIG. 8C), the browser software
86 can be installed on several data entry workstations 304
positioned in the same facility as the compounding device 18. The
browser software 86 of the data entry workstations 304 can be
linked, e.g., via a hub 306 or switch as a local area network to
the order entry process manager 84 residing in the MPU 58 in the
control panel 24 of the compounding device 18, to constitute a
multiple data entry station configuration. In this arrangement, the
display device 300 of each data entry workstation 304 supports the
browser-based interface of the order entry process manager 84 for
order entry to the compounding device 18 and label printing by the
printer 302. A single compounding device 18 can thereby be linked
to several order entry workstations 304. The display device 76 on
the control panel 24 of the compounding device 18 supports the
proprietary touch screen interface of the compounding control
manager 72 during operation of the compounding device.
[0118] In another arrangement (see FIG. 8D), the browser software
86 can be installed on several data entry workstations 304
positioned in the same facility as several compounding devices 18.
The browser software 86 of the data entry workstations 304 can be
linked, e.g., via a server 308 to form an intranet facility network
310, and the order entry process manager 84 residing in the MPU's
58 in the control panels 24 of the several compounding devices 18
can be linked to the server 308 via a hub 312, to constitute a
fully networked data entry, multiple compounding station
configuration. In this arrangement, the display device 300 of each
data entry workstation 304 supports the browser-based interface of
the order entry process manager 84 for order entry to the
compounding device 18 and label printing by the printer 302.
Multiple compounding devices 18 can thereby be linked to multiple
order entry workstations 304. The display device 76 in the control
panel 24 of each compounding device 18 supports the proprietary
touch screen interface of the compounding control manager 72 during
operation of the respective compounding device. As shown in FIG.
8D, the browser software can be installed in a PDA device 314, or
any other device that can run a browser, to provide different order
entry platforms.
[0119] In another arrangement (see FIG. 8E), the browser software
86 can be installed on one or more data entry workstations 304
positioned in a data entry facility 316 that is remote to another
facility 318 where one or more compounding devices 18 are located.
The browser software 86 on one or more data entry workstations 304
at the remote data entry facility 316 can be linked to the order
entry process manager 84 residing in the MPU(s) 58 in the control
panel(s) 24 of the compounding device(s) 18 at the remote
compounding facility 318 via the public internet 320. Of course,
other forms of remote linkage can be used. The browser software 56
can be installed, alone or with the installation on the remote
workstations 304, on one or more data entry workstations 304 at the
local compounding facility 318, and also linked to the order entry
process manager 84 in the MPU(s) 58 in the control panel(s) 24 of
the compounding device(s) 18 via the public internet 320. If the
facilities 316 and 318 are part of a common operating entity, the
order entry process manager 84 and browser software 56 can be
installed on a data collection/administration workstation 304
positioned in a data center facility 322 that is remote to both the
data entry and compounding facilities 316 and 322. The data center
322 maintains an information data base 324 of patient information
and compounding resources for the compounding facility 318, and
also be linked to the data entry facility 316 and the compounding
facility 318 via the public internet 320.
[0120] In a variation to the arrangement shown in FIG. 8E (see FIG.
8F), a host data entry service facility 326, where the order entry
process manager 84 is installed, can be coupled via the public
internet 320 to one or more remote data entry facilities 328A,
328B, 328C, 328D. The host data entry service facility 326 can also
be linked via a virtual private network 328 through the public
internet to a remote compounding facility 330, where the
compounding control manager 72 is installed in the MPU 58 in the
control panel 24 of the compounding device 18. The browser software
86 is installed on the data entry workstations 304 positioned in
the remote data entry facilities 328A to 328D. The host data entry
service facility 326 maintains the data collection and management
data base 332 for the entire network. In this way, multiple order
entry facilities 328A to 328D can be linked to a single compounding
facility 330 via an intermediary service facility 326, which can
also maintain a central collection and management data base
332.
[0121] B. Features of the Order Entry Process Manager
[0122] FIG. 10A shows a general schematic representation of the
operator-selectable functional modules that a representative
implementation of the order entry process manager 84 can possess.
As illustrated, these functional modules include a prescription
order module 400, a source solution module 402, a reports module
404, an administration module 406, and a navigation module 408. The
prescription order module 400 allows an operator to enter a
prescription order for a given patient, with reference to a
preexisting compound formula or to a new compound formula, as well
as schedule the order for compounding. The source solution module
402 maintains an inventory of available base source solutions and
additive source solutions that are cross-referenced in the formula
library of the prescription order module 400. The reports module
404 provides an operator the capability of tracking compounding
activities and generating various administrative reports relating
to these activities. The administration module 406 aids the
operator in the performance of various administration tasks in
support of the compounding activity. The navigation module 408
assists the operator in use of the order entry process manager 84.
Each module contains one or more functional components that an
operator can select in using the module, as will be described in
greater detail later.
[0123] A given operator can gain access to one or more of these
functional modules, depending upon the access options that the
system administrator grants a given operator, which depends upon
the functions that the operator is required to perform. For
example, a hierarchy of access options can be specified for use by
a physician or pharmacist, who specifies or enters compounding
orders; a compounding activity administrator, whose function is to
oversee the compounding function from an administrative standpoint;
and a compounding technician, whose function is to operate one or
more compounding devices 18. The available functional modules can
be displayed as menu box selections on a main screen or home page,
which opens once a given operator identifies itself by name and
assigned password on an appropriate log-on screen.
[0124] For example, FIG. 11A shows a representative main screen or
home page 410 for an operator who has a physician or pharmacist
access option. As FIG. 11A shows, all functional modules 400 to 408
are available for selection at this access level, because
performance of that person's function may require access to all
features of the order entry process manager 84. As a comparative
example, FIG. 11B shows a representative main screen or home page
410' for a compounding technician, which offers access to a lesser
selection of functional modules, because the technician's function
does not require access to all the functional features of the order
entry process manager 84. The functional module menu boxes which a
given individual may access may appear in a column along the left
side of other screens generated by the order entry process manager
84.
[0125] Assuming that the operator is at a physician or pharmacist
access level, and is thereby viewing the home page shown in FIG.
11A, the operator can, with a mouse click, select a desired
functional module. Assuming the operator seeks to enter a
prescription order for a given patient, the operator mouse-clicks
on the Patients component of the PRESCRIPTION ORDER menu box 400,
which opens the PATIENT MAIN PAGE 412 shown on FIG. 11C. This
window 412 provides access to the features of the Patient Data Base
Component 414 of the order entry process manager 84, the functional
units of which are shown schematically in FIG. 10B.
[0126] The Patient Data Base Component 414 allows a user to either
select an existing patient by a last name search of a list of
patient information files created in a patient information data
base maintained by the order entry process manager 84 (FIND A
PATIENT box field 416), or by entering the name of a new patient
(ENTER NEW PATIENT box field 418).
[0127] Upon finding an existing patient's name, the order entry
process manager 84 provides a window displaying the contents of the
corresponding Patient Information Record 420 (FIG. 11D). The
Patient Information Record 420 allows the operator to enter a new
compounding order, based upon previous compounding orders retained
in the patient data base for that patient (TPN ORDERS ON FILE FOR
PATIENT box field 422), or allows the operator to enter a new
compounding order for that patient based upon a standard default
templates for a patient type that the patient matches (NEW TPN
ORDER TEMPLATES AVAILABLE FOR STANDARD ADULT PATIENT TYPE box field
424).
[0128] The PRESCRIPTION ORDER MENU box 400 includes a Formula
Library component. When selected, the Formula Library component
provides access to the features of the Formula Library Data Base
Component 426 of the order entry process manager 84, the functional
units of which are shown schematically in FIG. 10C. Selection of
the Formula Library component opens a Formula Library web page 432
shown in FIG. 11F(1). The Formula Library web page 432 permits the
operator to select an existing default formula template for display
and selection in the Patient Information Record page 420, or to add
a new formula template for display in the Patient Information
Record. Selection of template opens a scrollable Order Template web
page 434 shown in FIGS. 11F(2), 11F(3), and 11F(4), that allows the
operator to specify base components (types and amounts) and
additive solutions (types and amounts) for a template formula.
Default data in an existing template formula can also be changed
and submitted. The Order entry process manager 84 computes the
nutritional requirements of the template formula based upon the
selected types and amounts of base components and additives,
drawing upon data contained in the source solutions module 402, as
will be described in greater detail later.
[0129] A mouse click selecting one of the order options 422 or 424
on the Patient Information Record opens a scrollable Order Entry
window 436 (FIGS. 11E(1) to 11E(4). The Order Entry window 436
includes field boxes that contain details of the PRESCRIPTION ORDER
(box 438), the BASE COMPONENTS included in the order (type and
amount) (box 440), the ADDITIVES included in the order (type and
amount) (box 442), the NUTRITIONAL SUMMARY (based upon the types
and amounts of the base components and additives included in the
order) (box 444), and the ORDER STATUS (which will be described
later) (box 446). The default listing of solutions and solution
amounts in the BASE COMPONENTS and ADDITIVE field boxes 440 and 442
are provided based upon the selection on the Patient Information
Record 420 to base the order upon a previous order or a standard
template. The default BASE COMPONENTS and ADDITIVES can be edited
to change the previous order or template type and/or amount, or
they can be submitted without change. The Order entry process
manager 84 computes the NUTRITIONAL REQUIREMENTS (box 444) based
upon the selected types and amounts of base components and
additives, drawing upon data contained in the source solutions
module 402.
[0130] The operator can open the Order Entry window (FIGS. 11E(1)
to 11E(4)) to enter a compounding order for a new patient (i.e., a
patient not previously entered into the patient data base) by
selecting ENTER A NEW PATIENT field box 418 on the Patient Main Web
Page 412 (FIG. 11C). With this selection, the order entry process
manager 84 opens a window displaying a New Patient web form 448
(FIGS. 11G(1) and 11G(2), prompting the operator to enter data
pertaining to the new patient. Upon entry of the new patient
information, the operator saves the information to the patient data
base (selecting the UPDATE field box 450--shown in FIG. 11G(2)), at
which time the scrollable Order Entry window 436 opens for entry of
the compounding order (FIGS. 11E(1) to 11E(4).
[0131] The last screen of the Order Entry window 436 (FIG. 11E(4)
includes an ORDER STATUS box 446. The ORDER STATUS box 446
comprises a listing of the functional steps in a compounding
operation that must be executed between order entry and delivery of
the compounded order to a patient. The ORDER STATUS box 446 also
colors or highlights the steps to indicate which steps have been
performed and which remain to be performed. The ORDER STATUS box
446 provides a check list of functions that must be performed to
carryout the compounding process and, at a glance, informs an
operator what function has been performed and what function still
needs to be performed. In the illustrated embodiment (FIG. 11E(4))
the function steps listed include OPEN, SUBMITTED, AUTHORIZED,
PRINTED, and COMPOUNDED.
[0132] The OPEN step entails the opening of the Order Entry window
436, the entry of information making up the compounding order, and
the mouse-clicking the OPEN icon 452. In FIG. 11E(4), the OPEN icon
452 is colored or highlighted, to indicate that this step has been
accomplished.
[0133] The SUBMITTED step entails mouse-clicking the SUBMITTED icon
454, which places the information in the database and thereby makes
the Order Entry window containing the pending compounding order
available for viewing on any workstation with a proper operator
access level, which, in this case, would be a designated
authorizing pharmacist. The SUBMITTED icon 454 is colored or
highlighted on the Order Entry window 436 when the step has been
completed. The order entry process manager 84 desirably keeps track
in the database of the compounding orders submitted by the various
order entry workstations that are awaiting authorization, so that
they can be accessed in an organized fashion by the browser
software at the workstation of the authorizing pharmacist. The
authorizing pharmacist knows to periodically run the browser
software to access this queue of pending orders, to review each
pending order, and indicate authorization of each order in the
AUTHORIZE THIS ORDER FOR COMPOUNDING field box 456 on the Order
Entry window 436.
[0134] In another arrangement, the order entry process manager 84
can include a notification function, which provides a pop-up
message at the workstation of the authorizing pharmacist to alert
the individual that there are entered compounding orders awaiting
authorization. Clicking on the pop-up message opens a list of the
orders awaiting authorization that the authorizing pharmacist can
access.
[0135] In the illustrated embodiment, authorization entails
clicking the authorization statement (box 458), selecting the shift
in which the compounding is to be performed (box 460), and
selecting the AUTHORIZE FOR COMPOUNDING icon 462. A STAT ORDER icon
464 is provided if the compounding order is to be performed as soon
as possible. The AUTHORIZED icon 466 is colored or highlighted on
the Order Entry window 436 when the authorization step has been
completed.
[0136] The order entry process manager 84 desirably keeps track of
the compounding orders that are in the database that have been
authorized and are awaiting the printing of labeling, so that this
subset of orders can be accessed in an organized fashion at a
workstation where printing occurs. These compounding orders are
accessed at the workstation where labeling for the final solution
container 14 is to be printed.
[0137] In another arrangement, the order entry process manager 84
can include a notification function, which provides a pop-up
message at the workstation where printing occurs to alert the
operator that there are authorized compounding orders awaiting
printing Clicking on the pop-up message opens a list of the orders
awaiting label printing that the operator can access to perform the
printing function.
[0138] The order entry process manager 84 formats the labeling (see
FIG. 12) based upon the information entered in the Order Entry
window 436. The labeling includes a label 468 for the final
solution container 14, a worksheet 470 identifying the source
solutions and targeted compounding volumes, a worksheet 472
providing nutritional information for the contents of the final
solution container 14, and a label 474 for a piggyback container,
if ordered. The labeling also includes the bar codes 476 that the
compounding control manager 72 requires to verify the compounding
order and perform the actual compounding process. The final
container bar code 476 (on the final solution container label 468)
can also be used to electronically transfer formula information
after compounding to a capable medication dispensing device (e.g.,
such as an infusion pump).
[0139] Upon completion of the printing step, the compounding order
is made available for electronic transfer to a compounding control
manager 72 of a compounding device 18. The PRINTED icon 478 is
colored or highlighted on the Order Entry window 436 when the
labeling printing step has been completed and the order has been
made available for transfer to the compounding control manager 72
for completion.
[0140] In the networked compounding environment that the order
entry process manager 84 makes possible, when it is time to
compound, the compounding clinician at the compounding station logs
into the compounding control manager 72 and selects the AUTO PGM
touch button 234 on the main screen 202 generated by the
compounding control manager 72 (see FIG. 9B). This opens a queue
selection screen 236 (FIG. 9P), which displays a list of
preprogrammed schedule queues that have been established by the
previously described order entry and processing steps, as
controlled by the order entry process manager 84. The operator
selects the desired queue (based upon the present compounding shift
- e.g., morning or afternoon) and presses the ENTER touch button on
the queue selection screen 236. The compounding control manager 72
holds the order queue list it receives from the order entry process
manager 84 in memory, and the main screen 202 (see FIG. 9Q)
thereafter allows the operator to view the current order queue list
in the window 238. In this arrangement, the operator selects the
order from the programmed order queue list 238 on the main screen
202, and then, as prompted by the compounding control manager 72,
proceeds to connect the final solution container 14 to the manifold
36, perform the source solution and final solution verifications,
perform the flushing sequences (if necessary), and starts
compounding in the manner previously described.
[0141] As previously described, the use of bar code data in the
verification function of the compounding control manager 72
necessitates that the labeling (FIG. 12) that is generated by the
order entry process manager 84 must be available to and used by the
compounding clinician in order to operate the compounding device
and complete the compounding order. This integrates the submission,
authorization, and printing functions of the order entry process
manager 84 with the control functions of the compounding control
manager 72.
[0142] The compounding control manager 72 communicates with the
order entry process manager 84 when the compounding process has
been completed, the COMPOUNDED icon 480 on the Order Entry window
is colored or highlighted accordingly.
[0143] The order entry process manager 84 can provide other
functions that can be accessed through the PRESCRIPTION ORDERS menu
box. For example, as shown in FIG. 11A, a Schedules component can
be included that allows the operator to view and alter the
scheduling of compounding orders by shifts.
[0144] On the home screen shown in FIG. 11A, the operator can, with
a mouse click, select other functional modules of the order entry
process manager 84. If, for example, the operator seeks to view the
inventory of base components maintained by the compounding
facility, the operator mouse-clicks on the Base Components function
of the SOURCE SOLUTIONS menu box 402, which opens the BASE
COMPONENTS MAIN PAGE 482 shown on FIG. 11H(1). This window provides
access to the features of the Base Solutions Data Base Component
428 of the order entry process manager 84, the functional units of
which are shown schematically in FIG. 10D.
[0145] When selected, the BASE COMPONENTS MAIN PAGE 482 (FIG.
11H(1)) permits the operator to select a base component maintained
in the existing facility inventory, or to add a base component to
the inventory. Selection of a base component opens a scrollable
Base Component Inventory Page 484 pertaining to the selected
component, as shown in FIGS. 11H(2) and 11H(3). The Base Component
Inventory Page 484 allows entry and retention by the order entry
process manager 84 of pertinent information pertaining to the
selected base component--e.g., its name; family type (Amino Acid,
Dextrose, Fat Emulsion, etc.); concentration; specific gravity;
cost per 100 mL; the choice of the pump rotor assembly of the
compounding device to convey the component; NDC lot number;
expiration date; electrolyte content, nutritional content, and
other information.
[0146] Similarly, if the operator seeks to access the inventory of
additive solutions maintained by the compounding facility, the
operator mouse-clicks on the Additive Solutions function of the
SOURCE SOLUTIONS menu box 402, which opens the ADDITIVE SOLUTIONS
MAIN PAGE 486 shown on FIG. 11I(1). This window provides access to
the features of the Additive Solutions Data Base Component 430 of
the order entry process manager 84, the functional units of which
are shown schematically in FIG. 10E.
[0147] When selected, the ADDITIVE SOLUTIONS MAIN PAGE 486 (FIG.
11I(1)) permits the operator to select an additive solution
maintained in the existing facility inventory, or to add an
additive solution to the inventory. Selection of an additive
solution opens a scrollable Additive Solution Inventory Page 488
pertaining to the selected additive solution, as shown in FIGS.
11I(2) and 11I(3). The Additive Solution Inventory Page 488 allows
entry and retention by the order entry process manager 84 of
pertinent information pertaining to the selected additive
solution--e.g., its solution type; its patient type; concentration;
specific gravity; cost per mL; the choice of the pump rotor
assembly of the compounding device to convey the component; NDC lot
number; expiration date; electrolyte content; and other
information.
[0148] The Base Solutions Data Base Component 428 and the Additive
Solutions Data Base Component 430 of the order entry process
manager 84 store pertinent information, for cross-reference by the
other functional modules of the order entry process manager 84. For
example, the Formula Library 426 draws upon information stored in
the Base Solutions Data Base 428 and the Additive Solutions Data
Base 430 to fill out the default information in the formula
templates. Thus, library solutions can be restricted by patient
type. As another example, the nutritional information derived by
the order entry process manager 84 contained in the printed
labeling (label 472 in FIG. 12) is drawn from information stored in
the Base Solutions Data Base 428. Administration reports (to be
described later) derive inventory, use, and cost management
information based upon information stored in the Base Solutions
Data Base 428 and the Additive Solutions Data Base 430.
[0149] From the home page shown in FIG. 11A, the operator can, with
a mouse click, select to access the report module 404. The operator
can select among a list of report selections contained in the
REPORTS menu box 404. The reports module 404 provides an operator
the capability of tracking compounding activities and generating
various administrative reports relating to these activities. The
nature and format of the reports can, of course, vary according to
the particular requirements of the compounding facility. The
reports module 404 can generate reports that, for example, (i) list
the compounding orders entered during a prescribed reporting period
(arranged, e.g., by patient, date, time, entry operator, and the
like); or (ii) list the compounding orders that were compounded
during a prescribed reporting period (arranged, e.g., by
compounding device number, date, time, compounding clinician,
patient, final container number, time elapsed, and the like); or
(iii) list source solution usage in liters during a prescribed
reporting period arranged, e.g., by solution type, day, month,
cost, and/or lot numbers, and the like; or (iv) list customer
billing records for completed compounded containers, including,
e.g., costs per mL of compounded fluid by solution type, flat rates
costs by container or solution type, labor costs by machine
compounding hours, flat labor costs, or a combination of any of
these; or (v) list a log of operators accessing the order entry
processing manager, arranged, e.g., by date, time, operator name,
and event. Any or all of these reports can be generated by the
reports module 404 of the order entry process manager 84 according
to preformatted templates, or by customized or relational field
searches of data bases maintained by the order entry process
manager 84 . The reports module 404 desirably includes the
capability of formatting the reports for printing in hard copy
format, or offloading the reports in electronic file format, e.g.,
in PDF file format.
[0150] From the home page shown in FIG. 11A, the operator can, with
a mouse click, select to access the administration module 406. The
operator can select among a list of administration options
contained in the ADMINISTRATION menu box 406. The administration
module aids the operator, who is in this instance typically the
compounding activity administrator or supervisor, in the
performance of various administration tasks in support of the
compounding activity.
[0151] The nature of the administrative functions supported by the
administration module 406 can, of course, vary according to the
particular requirements of the compounding facility. The
administration module 406, for example, can allow the administrator
to add, delete or modify the schedule of shifts during which
compounding takes place--which, in turn, becomes viewable (box 460)
in the Order Entry web page (FIG. 11E(4)), for selection by the
authorizing pharmacist during the order authorization process. The
administration module 406, as another example, can allow the
administrator to add, delete or modify the inventory list of
compounding devices maintained by the compounding facility - which
information, in turn, becomes available for use in the compounding
reports generated by the reports module 404. The administration
module 406, as another example, can allow the administrator to add,
delete or modify the categories of patient types (e.g., standard
adult; standard neonate; standard pediatric) accounted for by the
compounding facility--which, in turn, can be linked to the patient
information data base and can also be linked to the formula
template data base 426 maintained by the order entry process
manager 84 (i.e., a standard adult formula template can be linked
to a standard adult patient type, to facilitate the compound order
entry process). The administration module 406, as another example,
can allow the administrator to add, delete or modify the list of
operators by name or by operator groups (e.g., administrative
staff, pharmacy staff, pharmacy technician, supervisor) that are
permitted access to the order entry process manager 84, as well as
assign passwords and access rights particular to each operator and
each operator group. In this respect, operator's rights and
restrictions can be tailored for that operator individually, and
not as part of an overall group (e.g., as a technician or a
pharmacist). Groups can also be prohibited or allowed access to
certain patient types (e.g., Dr. Brown cannot see information
pertaining to Dr. Smith's patients).
[0152] On the home page shown in FIG. 11A, selection among the
options provided by the navigation module 408 of the order entry
process manager 84 can provide a short cut to the operator's home
page, a help function, a general data base search function outside
of the order entry, report, or administration functions, and/or a
user log-out function. Selective use of operator access rights
allows for patient record privacy in compliance with governmental
HIPAA regulations.
[0153] As can be by now be appreciated, the order entry process
manager 84 and browser software provide a physician or compounding
order facility the capability to electronically transfer
compounding requirements to a compounding facility via direct wire,
network, or internet based systems. The order entry process manager
84 and browser software provides a compounding facility the
capability to electronically enter compounding requirements on site
or to receive electronically generated customer compounding
requirements from remote sites. The order entry process manager 84
and browser software provide a compounding facility the capability
to queue multiple customer compounding requirements into an
efficient compounding and delivery schedule. The order entry
process manager 84 and browser software provide a compounding
facility the capability to generate container labels, including bar
codes, as well as control the actual compounding process. The order
entry process manager 84 and browser software provides a
compounding facility the capability to automatically generate
customer billing and inventory control for completed compounded
containers. Billing options can include costs per mL of compounded
fluid by solution type, flat rates costs by bag or solution type,
labor costs by machine compounding hours, flat labor costs, or a
combination of any of these.
[0154] Features of the invention are set forth in the following
claims.
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