U.S. patent application number 11/935546 was filed with the patent office on 2008-05-29 for method for transferring data to a pharmaceutical compounding system.
This patent application is currently assigned to B. BRAUN MEDICAL INC.. Invention is credited to Aleandro DiGianfilippo, Michael Golebiowski, Richard S. Pierce.
Application Number | 20080125897 11/935546 |
Document ID | / |
Family ID | 36565577 |
Filed Date | 2008-05-29 |
United States Patent
Application |
20080125897 |
Kind Code |
A1 |
DiGianfilippo; Aleandro ; et
al. |
May 29, 2008 |
METHOD FOR TRANSFERRING DATA TO A PHARMACEUTICAL COMPOUNDING
SYSTEM
Abstract
A method for use with a data entry system for providing input
data to a pharmaceutical compounding device having an associated
plurality of source solutions is provided. A first label comprising
first indicia defining a desired pharmaceutical compound is
generated. The first indicia is then provided to the pharmaceutical
compounding device as an input. The pharmaceutical compounding
device then prepares a pharmaceutical compound based on the first
indicia and generates a second label comprising second indicia
indicative of at least the contents of pharmaceutical compound. The
first indicia and second indicia are provided to a comparison
device where the contents of the actual pharmaceutical compound as
indicated by the second indicia are compared to the desired
pharmaceutical compound as indicated by the first indicia.
Inventors: |
DiGianfilippo; Aleandro;
(Scottsdale, AZ) ; Pierce; Richard S.; (Glendale,
AZ) ; Golebiowski; Michael; (West Lafayette,
IN) |
Correspondence
Address: |
RATNERPRESTIA
P O BOX 980
VALLEY FORGE
PA
19482-0980
US
|
Assignee: |
B. BRAUN MEDICAL INC.
Bethlehem
PA
|
Family ID: |
36565577 |
Appl. No.: |
11/935546 |
Filed: |
November 6, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11003232 |
Dec 3, 2004 |
7317967 |
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11935546 |
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10728560 |
Dec 5, 2003 |
7343224 |
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11003232 |
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10335552 |
Dec 31, 2002 |
7194336 |
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10728560 |
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Current U.S.
Class: |
700/110 ;
700/239 |
Current CPC
Class: |
A61J 2205/10 20130101;
G07F 11/70 20130101; A61J 2205/30 20130101; G16H 10/60 20180101;
A61J 3/002 20130101; A61J 2205/50 20130101; G07F 17/0092 20130101;
G16H 20/13 20180101; A61J 2205/70 20130101; A61J 2205/60 20130101;
G16H 20/17 20180101; G06F 19/00 20130101; G07F 13/06 20130101 |
Class at
Publication: |
700/110 ;
700/239 |
International
Class: |
G06F 17/00 20060101
G06F017/00 |
Claims
1. A method for use with a data entry system for providing input
data to a pharmaceutical compounding device having an associated
plurality of source solutions, the method comprising the steps of:
a) generating a first label comprising first indicia defining an
allocation of said plurality of source solutions; b) providing said
first label directly to said pharmaceutical compounding device; c)
reading said first indicia from said first label with said
pharmaceutical compounding device; and d) generating a
pharmaceutical compound with said pharmaceutical compounding device
based on said first indicia input into said pharmaceutical
compounding device.
2. The method according to claim 1, wherein said first indicia
further compromises information relating to a patient for which the
pharmaceutical compound is intended.
3. The method according to claim 1, wherein said first indicia
comprises a bar code.
4. The method according to claim 1, wherein said first indicia
comprises a two dimensional bar code.
5. The method according to claim 1, wherein said first label is an
electronic label.
6. The method according to claim 5, wherein said electronic label
is a Radio Frequency Identification label.
7. The method according to claim 6, wherein the providing step (b)
comprises the steps of: activating said electronic label with an RF
signal; and transmitting said indicia responsive to said RF
signal.
8. The method according to claim 1, wherein said data entry system
generates said first label.
9. The method according to claim 1, wherein at least one of the
first indicia or second indicia includes information for
instructing an infusion pump regarding delivery of the generated
pharmaceutical compound to a patient.
10. The method according to claim 1, wherein the first indicia
includes information for instructing an operator of the
pharmaceutical compounding device at which pumping stations to
install respective ones of said plurality of source solutions.
11. The method according to claim 10, further comprising the steps
of: scanning a bar code of said installed plurality of source
solutions; scanning a bar code of respective ones of transfer
tubing coupled to said plurality of source solutions and said pump
station; comparing the scanned information of the installed
plurality of source solutions and transfer tubing with an expected
configuration; and either permitting the operator to commence
compounding if the comparison is valid or preventing the operator
from compounding if the comparison is invalid.
12. The method according to claim 1, wherein Step d) comprises the
steps of: d1) pumping a first portion of at least one of the source
solutions at a first flow rate with a first pump element until a
predetermined threshold of the source solution is reached, and d2)
pumping a remaining portion of the at least one source solution at
a second flow rate with the first pump element until a target
volume of the source solution is reached, the second flow rate
being less than the first flow rate.
13. The method according to claim 1, further comprising the step of
generating a second label comprising second indicia indicative of
at least said pharmaceutical compound as generated by said
pharmaceutical compounding device.
14. The method according to claim 1, wherein the pharmaceutical
compound is a TPN compound.
15. A method for use with a data entry system for providing input
data to a pharmaceutical compounding device having an associated
plurality of source solutions, the method comprising the steps of:
a) generating a first label comprising first indicia defining an
allocation of said plurality of source solutions conforming to a
predetermined configuration; b) providing said first indicia to
said pharmaceutical compounding device as an input; c) reading said
first indicia from said first label with said pharmaceutical
compounding device; and d) generating a pharmaceutical compound
based on said indicia input into said pharmaceutical compounding
device by pumping at least two separate sources of a first type of
source solution simultaneously into a designated receptacle.
Description
[0001] This application is a Continuation of U.S. patent
application Ser. No. 11/003,232 filed on Dec. 3, 2004, which is a
Continuation-in-Part of U.S. patent application Ser. No. 10/728,560
filed on Dec. 5, 2003 which is a Continuation-in-Part of U.S.
patent application Ser. No. 10/335,552 filed on Dec. 31, 2002 which
claims the benefit of priority of U.S. Provisional Patent
Application Ser. No. 60/344,869, filed Dec. 31, 2001, and entitled
"Pharmaceutical Compounder and Information Management System".
[0002] A portion of the disclosure of this patent document contains
material which is subject to copyright protection. The copyright
owner has no objection to the facsimile reproduction by anyone of
the patent document or the patent disclosure, as it appears in the
Patent and Trademark Office patent file or records, but otherwise
reserves all copyright rights whatsoever.
FIELD OF THE INVENTION
[0003] This invention relates to a method for interfacing a
compounder used to compound liquids and/or drugs intended to be
administered to a human being or an animal with a
prescription/order entry system.
BACKGROUND OF THE INVENTION
[0004] 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 places
primarily at one of three sites. There 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.
[0005] 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.
[0006] Interfacing of the system used by the doctor for example to
enter a compound prescription/order for a patient has become a
problem. Especially so where the order system is part of a larger
system to which the compounder is not connected. Conventionally, in
these situations the order is written or otherwise entered into the
ordering system. The written order is then checked by the
prescribing doctor or clinical pharmacist for accuracy. After
approval, this printed order is provided to the pharmacy where it
must now be reentered into the compounder system. The transcription
of the written order is a source for errors resulting in a compound
that does not match the intended prescription.
[0007] Alternatively, there are systems in place that
electronically couple the order entry system and the pharmaceutical
compounder. These systems, however, are complex and in the case of
systems that do not share a common data protocol, require a
translation interface. Further, these systems may not be desirable
where autonomy of existing systems is required.
[0008] Therefore, what is needed is a system and method that
addressed the problems of the prior art and provides for inputting
of compounding data into a pharmaceutical compounded such that
transcription errors are minimized if not eliminated entirely.
SUMMARY OF THE INVENTION
[0009] In view of the shortcomings of the prior art, the present
invention is a system and method providing input data to a
pharmaceutical compounding device having an associated plurality of
source solutions.
[0010] One method comprising the steps of generating with said data
entry system includes a first label comprising first indicia
defining an allocation of said plurality of source solutions
conforming to either a predetermined or undefined configuration;
providing said first indicia to said pharmaceutical compounding
device as an input; and generating a pharmaceutical compound based
on said indicia input into said pharmaceutical compounding
device.
[0011] According to another aspect of the invention, further steps
include generating a second label comprising second indicia
indicative of at least said pharmaceutical compound; providing said
second indicia to said at data entry device as an input; and
comparing said allocation of said plurality of source solutions
with said second indicia in said data entry device.
[0012] Another aspect of the invention provides generating a first
output if it is determined that a mismatch of said allocation of
said plurality of source solutions and said pharmaceutical compound
has occurred.
[0013] Another aspect of the invention provides generating a second
output if it is determined that the allocation of said plurality of
source solutions and matches the allocation of source solution in
the pharmaceutical compound.
[0014] According to another aspect of the invention the second
indicia also compromises information relating to a patient for
which the pharmaceutical compound is intended.
[0015] According to another aspect of the invention at least one of
the first indicia and/or the second indicia comprises a bar
code.
[0016] According to yet another aspect of the invention, either or
both labels are RFID tags and the indicia associated with the tags
is stored in electronic form therein.
[0017] Another aspect of the invention is a system for providing
input data to a pharmaceutical compounding device having an
associated plurality of source solutions. The system comprises
means for generating a first output comprising first information
defining at least an allocation of said plurality of source
solutions conforming to a predetermined configuration; means for
transferring said first information into said pharmaceutical
compounding device; means for generating a pharmaceutical compound
based on said first information; means for generating a second
output comprising second information indicative of at least said
pharmaceutical compound; means for comparing said second
information with said first information; and means for determining
if said pharmaceutical compound matches said predetermined
configuration.
[0018] According to another aspect of the invention, either or both
of the first and second information are in electronic form stored
in respective RFID tags.
[0019] Other features and advantages of the inventions are set
forth in the following specification and attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] The invention is best understood from the following detailed
description when read in connection with the accompanying drawing.
It is emphasized that, according to common practice, the various
features of the drawing are not to scale. On the contrary, the
dimensions of the various features are arbitrarily expanded or
reduced for clarity. Included in the drawing are the following
Figures:
[0021] 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.
[0022] FIG. 2A is a view of a disposable transfer set that can be
used in association with the compounding device shown in FIG.
1.
[0023] 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 back flow
of liquid in the manifold and lipid hazing.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] FIG. 5 is a perspective view of a compounding device shown
in FIG. 4, with a transfer set mounted in the peristaltic pumping
station.
[0029] 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.
[0030] FIG. 6B is an exploded perspective view of the peristaltic
pump components shown in FIG. 6A.
[0031] FIG. 7 is a top view of the compounding device shown in FIG.
6A.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] FIGS. 11A to 11J 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.
[0036] 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.
[0037] 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.
[0038] FIGS. 14A-14B 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.
[0039] FIG. 15A-15B are representative screens related to
configuration of the exemplary system.
[0040] FIG. 16 is a representative screen illustrating the freeze
screen function of the exemplary system.
[0041] FIG. 17 is a representative screen illustrating the check
list function of the exemplary system.
[0042] FIG. 18A-18B are representative screens illustrating the
infusion pump selection function of the exemplary system.
[0043] FIG. 19 is a representative screen illustrating the
nutritional assessment function of the exemplary system.
[0044] FIG. 20A-20B are representative screens illustrating the
physician entry/selection function of the exemplary system.
[0045] FIG. 21A-21B are representative screens illustrating the
additive solution function of the exemplary system.
[0046] FIG. 22 is a block diagram of an exemplary embodiment
illustrating transfer of information for an ordering system to a
pharmaceutical compounder of the present invention.
[0047] FIGS. 23A-23B are examples of a barcode output from the
order entry device of the exemplary data transfer system.
[0048] FIG. 24 is an example of an output from the pharmaceutical
compounder of the exemplary data transfer system.
DETAILED DESCRIPTION OF THE INVENTION
[0049] 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.
[0050] 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.
[0051] 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.
[0052] 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
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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 (as FIG. 4
shows), 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 may include, but does not require, a
source solution support frame 32. The support frame 32 carries
several individual hangers H, which, during compounding, support
the individual source containers 16. When a source solution support
frame 32 is not included in device 18, other means can be used to
support the individual source containers 16.
[0057] 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.
[0058] 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.
[0059] 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 or other
source transfer tubing 34.
[0060] 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 include
multiple side-by-side banks of peristaltic pump rotor assemblies
54.
[0061] 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.
[0062] 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.
[0063] The controller 20 (see FIG. 13) 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 58 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.
[0064] 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.
[0065] 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.
[0066] The compounding control manager 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).
[0067] 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.
[0068] 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. In embodiments that include
RFID tags, rather than bar coded indicia, a commercially available
RFID reader (not shown) is substituted for bar code reader 82.
Further details of this aspect of the system 10 will be described
later.
[0069] 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.
[0070] 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.
[0071] 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
[0072] 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 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.
[0073] A. The Peristaltic Pumping Station
[0074] 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.
[0075] 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.
[0076] A fixed idler shaft 104 extends through the bearing plates
92 on a bushing 108, spaced from and offset from the drive shaft
94. Each pump rotor assembly 54 also includes a driven gear 106.
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.
[0077] 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.
[0078] 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.
[0079] 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.
[0080] Desirably, the unique matching code includes for example
bar-code indicia, e.g., one or two-dimensional bar code. Alternate
embodiments may employ other types of indicia, such as RFID tags
for example, into which the information is stored. 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 source 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. Bar
code scanning can also desirably include determining lot number
recording prior to compounding, and warning/preventing use of a
source solution that has an expired date or will become expired
within a predetermined period. As such, recording of solution lot
numbers can be automated and tied to the compounded bag and the
waste of valuable source solutions is avoided as well as avoiding
the possibility of providing a final solution that may not be as
effective as a solution that did not contain an expired
component.
[0081] 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.
[0082] 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.
[0083] B. Pump Control Criteria
[0084] 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.
[0085] 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.
[0086] 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.
[0087] 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.
[0088] The preprogrammed rules of the compounding control manager
72 institute desirable closed-loop control of the pump drive motor
64. The closed-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.
[0089] Shown below is the fundamental PID equation is, where `e` is
the error between the desired motor speed and the actual motor
speed and `u` is the new motor drive power level to try to adjust
for the error:
u = K P e + K I .intg. e t + K D e t Eq . 1 ##EQU00001##
[0090] where: [0091] (P)roportional--The proportional (direct)
response to motor speed error. [0092] (I)ntegral--The integral
(quick speed change) to difference between the desired speed and
actual speed. This normally comes into play at motor start-up,
where the motor power needs to go from zero to full power very
quickly. [0093] (D)erivative--The derivative (accumulated) response
to motor speed error. This is what causes the motor power to
steadily increase as necessary in the presence of high loads, for
example.
[0094] In Eq. 1, an integer math approximation of the error between
the desired motor speed and the projected motor speed is performed
based on the current motor speed and acceleration. This error value
is then used to adjust the motor drive power level up or down as
appropriate.
[0095] By using the absolute error value (scaled appropriately) as
the motor power adjustment value, the (P)roportional part of the
PID equation is approximated.
[0096] By the choice of value ranges and scales, the (I)ntegral
part of the PID equation is approximated. This is accomplished by
making the error value scale large compared to the motor drive
power, so that a moderate error value (much less than the maximum
possible error) drives the motor power level to saturation.
[0097] Furthermore, by adjusting the motor drive power level
instead of determining a new motor drive power level at each PID
control loop iteration, the (D)erivative contribution of the PID
equation is approximated.
[0098] This results in a motor control algorithm that performs like
a conventional PID algorithm, with improved transient response and
smooth control.
Quadrature Decoder Implementation
[0099] Unlike a conventional quadrature decoder, our decoder does
not generate Up and Down pulses to pump drive motor 64; rather it
simply determines the direction that pump drive motor 64 is
currently spinning. The PPU 60 monitors the direction signal and
statistically determines if the motor is spinning in the programmed
direction, and generates an alarm if not. This results in the use
of a minimum number of parts to implement the quadrature decoding
function, which in conventional systems, require additional PPU
inputs or more expensive external parts.
[0100] 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.
[0101] 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, such as Hall effect
sensors coupled to each rotor, 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 such as that caused by hydraulic effect
whereby the tubing of the transfer set will return to its normal
cross-section after pressure from pumping is removed.
[0102] The PPU 60 monitors the output of the Hall effect sensors to
determine which rotor(s) are spinning. This information is used to
generate appropriate alarms, such as: [0103] 1. Rotor moving when
it shouldn't be--this is a potential hazard because it can cause
incorrect solution to be delivered to the final container. The
exemplary system monitors for this condition and issues an alarm
when it occurs, and advises the operator that the final container
should not be used to treat a patient. [0104] 2. Rotor not moving
when it should be--this is not a hazard, but is detected and
reported to the operator as a malfunction.
III. Technical Features of the Transfer Set
[0105] 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.
[0106] 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.
[0107] 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 (or RFID scanning where appropriate), 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.
[0108] 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.
[0109] 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.
[0110] 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.
[0111] 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.
[0112] 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
[0113] A. The Compounding Control Manager
[0114] 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.
[0115] 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.
[0116] 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.
[0117] FIGS. 9A to 9W, 15A-15B, 16, and 17 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.
[0118] After an initial start-up mode of software initialization, a
main work 10 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 himself, either by using the
bar code or RFID 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.
[0119] The system desirably includes various set-up procedures that
provide various safeguards for the operation of the system. FIG.
15A is one such configuration screen 1500 for setting up approvals
required for all compounding operations. As shown in FIG. 15A, upon
selection of tab 1502, screen 1500 is presented to the operator,
such as the administrator of the system or another individual that
has such high level system administrative access. In this example,
Screen 1500 presents a three tier selection for each of several
classes of patients. Approval requirements are independent of one
another across patient classes. Examples of approval levels are
"NONE"--no approval necessary of any compounding function; "After
Source Change"--Requiring approval from an upper level employee,
such as a pharmacist, after any of the various source solutions are
changed and/or replaced; "ALWAYS"--Requiring approval from an upper
level employee for all compounding functions. The latter approval
setting may be invoked for example for a new or junior level
technician, or whenever such oversight is desired.
[0120] FIG. 15B illustrates Barcode Configuration screen 1504. As
shown in FIG. 15B, screen 1504 is presented to the operator upon
selection of tab 1506 and allows the operator to set up the
communication port via pull down 1508, as well as permitting the
selection of other attributes of the port, such as Port Speed,
parity, word length, etc., via pull down 1510. The operator is also
presented with a variety of check boxes 1512 allowing the operator
to select other check routines, such as requiring barcode
confirmation before allowing compounding to start (1514); requiring
source solution barcode confirmation at setup (1516); requiring
source container barcode confirmation after a no-flow alarm is
indication (1518); and requiring final container label barcode
confirmation (1520). The checks provide additional means to help
avoid human error in the preparation of the final solution.
[0121] 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. 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.
[0122] 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.
[0123] 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.
[0124] 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.
[0125] 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.
[0126] 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(1)). The operator is also prompted by screen 900, as shown
in FIG. 9I(2), to confirm that the new transfer set has been
installed and that it does not contain any solution is presented as
option choice. Alternatively, if the operator is continuing to use
the previous set up or a default setup to compound, the source
solution setup screen 904 (FIG. 9I(3)) is presented at start-up
asking the operator to make the appropriate selection as well as
asking the operator to confirm that if a new transfer set was as
installed, to ensure that the transfer set tubing is free of all
solutions before proceeding. After full confirmation is
accomplished, the operator can press an OK touch button in the
solution confirmation box 228.
[0127] 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 can also monitor 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.
[0128] 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.
[0129] Alternatively, the operator can select an AUTO PGM touch
button 234 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 236. 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.
[0130] If, during the selection process outlined above, the
operator programs a dextrose source solution and a Lipid source
solution screen as part of the same compound with one immediately
proceeding or following the other, the process recognizes this and
displays screen 902 (FIG. 9G(1)) to the operator to avoid a
situation whereby a breakdown (or cracking) of the lipid may occur
without the introduction of the buffer solution. Also, and as it
relates to additive solutions discussed below, a check whether
calcium and/or phosphate are added to the final solution is
conducted to avoid the formation of an insoluble precipitate. In
the event that an improper concentration of these components is
detected, the operator will be alerted with a display screen (not
shown) similar to screen 902.
[0131] It may be the case that certain source solution are
contained in small vials, rather than large bags or bottles. As
such, these vials will necessarily have a small stopper end from
which the solution will be extracted. Such a small stopper will
limit the flow rate of the solution when compared to other types of
source solution containers and may result in a flow rate that will
fall below the normal flow rate that the system expects, thereby
resulting in an alarm condition. To overcome this problem the
system allows the operator to instruct the system though an
appropriate screen selection that the source solution is being
sourced from a vial or other reduced flow container. In response,
the system will limit the upper speed on the pump when that
particular source solution is pumped to avoid the false indication
of reduced flow.
[0132] 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, 3, and 9
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.
[0133] 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.
[0134] 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. In an alternate representation, once compounding is
complete screen 910 (FIG. 9O(1)) is displayed. As shown in FIG.
9O(1), screen 910 includes patient name 912, the type of order 914,
the amount ordered by volume (916) and/or weight (918), the amount
of compound delivered by volume (920) and/or weight (922), and
accuracy 924. The operator may close this screen by selecting "OK"
926 to continue.
[0135] The operator can then reprogram the compounding control
manager 72 to carry out another compounding regime by following the
above sequences of steps.
[0136] There are other graphical buttons on the main screen 202
(see FIG. 9B), 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 258 (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.
[0137] In the illustrated embodiment, the main screen 202 also
includes a CALIBRATE SCALE touch button 262 (see FIG. 9B). When
pressed, the button 262 opens an instruction screen 270 (FIG. 9W),
that leads the operator through a sequence of steps that calibrate
the load cell. Alternatively, this function (CALIBRATE SCALE) may
be provided within or as part of other screens (not shown)
presented to the operator.
[0138] 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.
[0139] 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
stored formatted 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.
[0140] 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.
[0141] 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.
[0142] 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.
[0143] 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.
[0144] Other useful features of the system include, for example,
the activation of a process to freeze entry display screen 76 (or
any other touch screen used to enter data and/or commands into the
system). FIG. 16 illustrates this. As shown in FIG. 16, screen 1600
may be invoked as desired via a selection from the main system
screen (not shown). Once activated, the display screen 76 is frozen
and will not interpret tactile input on the display screen 76 as an
attempt to enter data or otherwise instruct the system. In this
way, the operator may clean the screen without jeopardizing an
ongoing process or begin an unintended process, thereby avoiding
waste of valuable source solutions and/or final solutions. The time
that display screen 76 is frozen is preferably predetermined, such
as 30 seconds, but may be adjustable if desired in a particular
configuration.
[0145] Additionally, and as shown in FIG. 17, the process can also
include screen 1700 that will advise the operator of items that
need to be completed on that particular day. It is also possible to
configure the checklist such that it advises the operator of items
that span multiple days if desired.
[0146] B. The Order Entry Process Manager
[0147] 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.
[0148] 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 376 (as
shown in FIGS. 8B to 8F). The order entry process manager 84 also
is desirably linked to a printer 302 (or 80), for providing reports
and labeling in paper form.
[0149] 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.
[0150] 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.
[0151] C. Associations with the Compounding Control Manager
[0152] 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.
[0153] 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.
[0154] 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 376 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.
[0155] 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 376 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.
[0156] 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.
[0157] 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.
[0158] 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.
[0159] B. Features of the Order Entry Process Manager
[0160] FIG. 10A(1) 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.
[0161] FIGS. 10A(2)-10A(6) illustrate a flow chart of the logon
sequence and the level of access given to various users, such as
the administrator (FIG. 10A(3)), Pharmacist (FIG. 10A(4)),
Technician (FIG. 10A(5), and Guest (FIG. 10A(6)), for example. As
shown in FIG. 10A(2), the administrator has the highest level of
access and can ultimately control access by any other user. The
administrator can also create additional classes of users as well
as subclasses within any class of users. For example, although
technicians are given very restricted rights within the system to
formulate compounds for instance, it may be that there are certain
technicians that require less oversight and can thus be granted
greater privileges.
[0162] 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.
[0163] 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.
[0164] 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.
[0165] 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).
[0166] 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). The operator can also review an existing nutritional
assessment or start a new nutritional assessment as desired.
Nutritional assessments are discussed in detail below with respect
to FIG. 19.
[0167] 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 420
shown in FIG. 11F(1). The Formula Library web page 420 permits the
operator to select an existing default formula template for display
and selection in the Patient Information Record page 424, 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.
[0168] 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 422). 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.
[0169] It is also important that medical personnel be able to
perform a nutritional assessment of the patient. That is, to make
determinations of patient nutritional needs and compare those needs
to the orders for the patient. As such, when the operator makes a
selection in section 423 of the patient's record (see screen 420
shown in FIG. 11D for example) he is provided with the Nutritional
Assessment Screen 1900 (FIG. 19). The selection in screen 420 may
be either to review an existing assessment or to perform a new
assessment. Screen 1900 is divided into three sections, Patient
Demographic Information 1902; Patient Assessment Information 1904;
and Calculated Nutritional Requirements 1906.
[0170] The Patient Demographic Information Section 1902 includes
certain demographic information concerning the selected patient and
may include for example, Patient Name; Patient ID; Patient Age;
Patient Sex; Patient Height; Patient Weight; Location of the
Patient; Diagnosis; Physician; Allergies; and a Picture of the
Patient.
[0171] The Assessment Section 1904 includes a brief patient
descriptor composed of the patient's sex, age, and height. The
screen desirably includes a Date/Time stamp for when the assessment
was last updated. The Assessment Section 1904 also includes various
input fields, such as a Text Box for the Assessment Title; a
Numeric Text Box for Patient Weight in the local units (default
value-weight in patient demographic data); a Pull-down List of
Injury Factors, including for example, Low (uncomplicated, general
surgery) (default); Moderate (complicated, extensive surgery); High
(sepsis, burns); a Pull-down List of Stress Factors, such as Mild,
Moderate, Severe, Renal Dysfunctional/Dialysis, and Renal
Dysfunctional/Non-Dialysis.
[0172] The Assessment Section 1904 also includes two buttons 1905,
1907. When selected, the "Update Assessment" Button 1905 takes the
information on the screen and uses it to calculate the nutritional
requirements which will be presented in the Calculated Nutritional
Requirements section and also updates the Assessment's Date/Time
Stamp. If this is a new assessment, a Cancel Button is provided,
that if selected will abort the assessment creation and return to
the previous screen. If this is an existing assessment, a Delete
Assessment Button 1907 can be used to remove the assessment from
the list of assessments associated with the patient.
[0173] The Calculated Nutritional Requirements Section 1906
desirably provides the following information preferably calculated
to two decimal places based on the patient information provided in
the Patient Assessment Section 1904, such as Ideal Body Weight;
Condition Assessment; Adjusted Body Weight; Basil Energy
Expenditure in Kcal/Day; Total Protein Requirements in gm/Day &
gm/Kg/Day; Total Calories Requirement in Kcal/Day &
Kcal/Kg/Day; and Fluid Requirement Range in mL/Day.
[0174] The Calculated Nutritional Requirements Section 1906
desirably provides a link 1908 to allow the user to compare the
current nutritional assessment to existing orders for the patient.
When exercised, a Nutritional Assessment Comparison Order Selection
Screen appears.
[0175] The Calculated Nutritional Requirements Section 1906 also
desirably provides a link 1909 to allow the user to enter a TPN
order based on the current nutritional assessment. When selected,
the TPN Order Screen (see FIG. 20) is provided with the fields
populated based on the current patient and the nutritional needs of
the patient. When the operator is finished with this screen he
activates the "Done" button 1910 to return to the calling screen.
It is also contemplated that alternative or customized nutritional
assessment calculations may be included as part of the exemplary
system.
[0176] 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. 1C). 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)).
[0177] The next screen of the Order Entry window 436 (FIG. 11E(4))
includes an ORDER STATUS box 422. The ORDER STATUS box 422
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 422 also
colors or highlights the steps to indicate which steps have been
performed and which remain to be performed. The ORDER STATUS box
422 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.
[0178] The OPEN step entails the opening of the Order Entry window
436, and the entry of information making up the compounding order.
In FIG. 11E(4), the OPEN icon 452 is colored or highlighted, to
indicate that this step has been accomplished.
[0179] As part of the order entry, a Final Container is
automatically selected based on an inventory of available final
containers. This list is desirably prepared by the system
administrator or other individual having such rights. Set up of the
inventory is illustrated in FIG. 11E(5). As shown in FIG. 11(E)5,
upon selection of the final container line item 492 of the
Inventory Configuration module 490 of the order entry process
manager 84 a list 491 of available final containers is displayed.
Through this screen, the administrator may review the listing of
available containers, and if necessary delete a container no longer
in stock, if desired.
[0180] In normal operation, a final container conforming to the
volume of the final solution ordered will be automatically
selected. Alternatively, through a manual operation the operator
may select a final container presented through a list which may be
similar to that of FIG. 11(E)5. In the event that the operator
selects a final container that is too small of the final solution,
an error indication will be provided and the operator will be
instructed to make an alternate selection.
[0181] If the administrator needs to add a new container to the
inventory this may be accomplished by selecting "Add a New Final
Container" selection 494, whereupon screen 493 (FIG. 11E(6)) is
presented to the operator. As shown in FIG. 11E(6), the
administrator has the capability to enter a description for the new
container, as well as particulars of the container, such as rated
size, maximum capacity, nominal empty weight, maximum under normal
weight, maximum over normal weight and unit cost. If the
administrator decides to save the information into the inventory,
he selects "Update," otherwise, the administrator can delete the
record to start over again, or select "Cancel" to exit this screen
without changing the inventory configuration. The data regarding
the final containers is also available for access via the
compounder control panel screen.
[0182] Although the majority of the final solution is comprised of
portions of various source solutions, there are other components
that may be necessary to complete the particular patient's
nutritional needs. For example, there are a various additive
solutions, such as electrolytes, vitamins, minerals, etc. that may
need to be included based on the patient's nutritional assessment.
In many cases, these individual additives may need to be added in
such minute amounts that automated macro-compounding is not useful.
To overcome this, it is possible to "pool" the various additive
solutions into a pooled additive bag to be used as another source
solution for use during the compounding process. For example, if a
patient is to receive as part of his daily compounded solution 1 mL
of a vitamin, 2 mL of sodium chloride, and 3 mL of potassium
phosphate each day over a ten day period, a pooled solution
consisting of 10 mL of the vitamin, 20 mL of sodium chloride, and
30 mL of potassium phosphate may be compounded with the present
invention to create a 60 mL source solution. Then, when the daily
final solutions need to be compounded, this additive source
solution may be included and selected to provide 6 mL of the pooled
solution. The details related to this are described below.
[0183] TPN Order Entry Screen 2100 (FIG. 21A) desirably provides
the Patient Name, Patient ID and Order ID (if linked to from the
TPN Order Entry Screen) or the Formula Template name of which the
Base Component Solution is a component (if linked to from the TPN
Order Template Screen). As part of the Screen 2100, a prescription
order section 2102 is provided. Within section 2102 is a "Batch
Copies" entry 2103 which is used to prepare multiples of a
particular order. In this example, seven (7) identical batches are
to be prepared. In addition, screen 2100 includes section 2104
relating to Additives to be used in the order. Section 2104
desirably presents for example the name of the Additive Solution in
the selected color, the amount ordered and ordering units in the
current formula, Dose Amount; a pull down for Dose Order Units with
a default unit of measure (based on the unit in the database entry
for the selected additive); Per Amount unit; mL (default); Lb; 500
mL; 100 Lb; 250 mL; 100 mL; Kg; 100 Kg; Liter; Kg-mL; Kg-l; Lb-mL;
Lb-l.
[0184] If these additives are selected to be part of the active
pooling inventory (see FIG. 21B), upon the user selecting Pool
Additives 2111 and then activating the "Submit Changes" button, the
system will automatically create a pooled additive solution. Upon
completion of the pooled additive solution, the system will
identify the pooled additive solution with an identifier desirably
including the patient's name and a bar code identifier. This pooled
additive will now be considered as another source solution for
compounding and added to Base Compounds section 2108 of screen
2100.
[0185] Section 2104 also provides access to the additive source
inventory screen 2120 (FIG. 21B) by selecting the Edit detail link
2110. Depending on the user's permission level, the user may review
the details of a particular additive or edit those details. Of
significance to the pooling function is the "Additive Pooling"
selection 2122. If an additive is allowed to be part of the pooling
process the "Allow" selection is enabled, otherwise, the "disallow"
selection is enabled.
[0186] User screen control options include for example, a button to
Submit ("Update") the changes, thereby updating the individual
order/order template; a button to Return ("Cancel") without making
any changes, and a "Delete" function to delete this particular
additive from the inventor (assuming the required permission
level). Desirably, the screen provides the following exemplary
information regarding the current additive solution from the
database: Name of the Additive Solution; Concentration; Specific
Gravity; Osmolarity--mOsm/L; Cost--Localized Current Value/mL; and
Electrolyte Content Details.
[0187] The SUBMITTED step entails mouse-clicking the DONE button,
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.
[0188] 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.
[0189] 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.
[0190] 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.
[0191] 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.
[0192] 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 470 for the final
solution container 14, a worksheet 468 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 470)
can also be used to electronically transfer formula information
after compounding to a capable medication dispensing device (e.g.,
such as an infusion pump).
[0193] 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.
[0194] 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.
[0195] 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.
[0196] 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.
[0197] 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.
[0198] 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.
[0199] 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.
[0200] 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.
[0201] 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 486
pertaining to the selected additive solution, as shown in FIGS.
11I(2) and 11I(3). The Additive Solution Inventory Page 486 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.
[0202] 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.
[0203] 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.
[0204] 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.
[0205] 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).
[0206] An example of how physicians can be added is described with
reference to FIGS. 20A and 20B. Within administration module 406 is
a selection Individual Physicians 407, which upon selection
provides screen 2000 (FIG. 20A) to the user including physician
list 2002. If a physician needs to be added to the list, the
operator selects link 2002 which brings up physician information
screen 2006 (FIG. 20B). The Physician Information screen 2006
includes certain information concerning the physician which
desirably includes for example, Login ID; A facility pull down to
limit the facilities in which this physician has privileges; Name;
Title; Address; Office Telephone Number; Mobil Telephone; Pager
Number; Facsimile Number; email address; additional contact
information; Federal Physician ID; and after hours service number.
The Physician Information screen 2006 also includes two buttons
2007, 2008. When selected, the "Update" Button 2007 takes the
information on the screen and saves it into the Physician database.
When selected, the Cancel Button will abort the present screen and
return to the previous screen without updating the Physician
database.
[0207] 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.
[0208] 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.
[0209] A Daily Checklist which is derived from screen 500 (FIG.
11J(1)-11J(2)) is desirably displayed upon log on of the operator
at the control panel. Items on the checklist may be added or
rearranged as necessary or desired. It is desirable that all active
items be displayed. If an item is indicated as being complete, the
date/time and ID of the operator will be entered into the log.
Required items must be completed before compounding is allowed to
occur.
[0210] As shown in FIG. 18A, upon selecting the Infusion Pump line
item 495 of the Inventory Configuration module 490 of the order
entry process manager 84 a list 496 of available infusion pumps is
displayed. The infusion pump is the device that is used to deliver
the final solution prepared by the compounder to the patient.
Through this screen, any one of the available infusion pumps may be
selected for use as the means to deliver the final solution to the
patient. Once an infusion pump is selected, ramp-up and ramp-down
profiles we be made available to the operator via drop-down lists
for loading into appropriate text fields. This is useful in
configuring how the infusion pump is to deliver the final solution
to the patient, so as not to start the delivery of the nutrients
too quickly (ramp up) nor to abruptly discontinue feeding toward
the end of the final solution container (ramp down). The bar coding
on the final solution container provides information and/or
instructions to the infusion pump regarding the selected flow rate
and/or ramp up/ramp down times. Manual entries will also be
allowed. If the operator needs to add a new infusion pump to the
inventory (primarily because the patient has a different infusion
pump already installed at their bedside or home) this may be
accomplished by selecting "Add a New Infusion Pump" selection 497,
whereupon screen 498 (FIG. 18B) is presented to the operator. As
shown in FIG. 18B, the operator has the capability to enter a
description for the infusion pump as well as certain particulars
about the new pump. If the operator decides to save the information
into the inventory, he selects "Update," otherwise, the operator
can delete the record to start over again, cancel to exit this
screen without changing the inventory configuration.
[0211] With respect to interfacing compounding system 10 to other
information systems, such as hospital or home care pharmacy
systems, the inventors have determined that electronic handshaking
and protocols necessary to carry out this interface are
complicated, add additional cost, and may be counter to the desires
of the hospital to maintain autonomy of their systems. Thus, a
further embodiment of the present invention provides an interface
that is less complex and does not rely on handshaking protocols to
transfer compounding information to compounding system 10.
[0212] Referring now to FIG. 22, a block diagram of hospital or
home care pharmacy system 2200 is illustrated. As shown in FIG. 22,
system 2200 comprises input devices, such as keyboard 2202 and
mouse 2204, processor 2206 (shown for example as contained within
display device 2208), and printer 2214. In one non limiting
example, system 2200 may be centrally located on a patient floor.
In another non limiting example, system 2200 may be part of a hand
held computing device, such as a PDA and may include or be
detachably coupled to a small printer via either direct wiring
(USB, fire wire interface, etc.) or via well-known wireless
communication link.
[0213] Referring again to FIG. 22, when a physician determines the
needs of a patient, the physician may enter or have entered into
system 2200 a desired compound defining solution types and
respective volumes. The desired compound is displayed to the
physician via display 2208 where, upon verification for accuracy, a
printout of the required compound is output from printer 2214 as
paper or label 2216. Although a standard printed page may be
useable to carry out the present invention, it may be desirable to
use label material as will become evident below.
[0214] In one exemplary embodiment, indicia in the form of a
barcode may be imprinted as part of label 2216. It is contemplated
that various fields of the barcode will indicate certain
characteristics of the desired compound. All necessary information
to prepare a desired compound is included within the barcode,
including desired solutions and respective volumes, patient ID (not
absolutely necessary but highly desirable in order to prevent
administering the compound to the wrong patient), order number, and
compound bag ID number. An example of Barcode fields is listed
below:
[0215] 1. "O"=Barcode Identifier Code (upper case letter `O`).
[0216] 2. Order Control Flags (see notes below)
[0217] 3. Patient ID, maximum of 12 characters (see notes
below)
[0218] 4. Order ID, maximum of 30 characters (see notes below)
[0219] 5. Bag ID, maximum of 12 characters (see notes below)
[0220] 6. Station #1 Volume: value can be 0, 5.0 to 99.9, or 100 to
5000 mL
[0221] 7. Station #1 Solution Name, blank to skip station
programming
[0222] 8. Station #2 Volume: value can be 0, 5.0 to 99.9, or 100 to
5000 mL
[0223] 9. Station #2 Solution Name, blank to skip station
programming
[0224] 10. Station #3 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0225] 11. Station #3 Solution Name, blank to skip station
programming
[0226] 12. Station #4 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0227] 13. Station #4 Solution Name, blank to skip station
programming
[0228] 14. Station #5 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0229] 15. Station #5 Solution Name, blank to skip station
programming
[0230] 16. Station #6 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0231] 17. Station #6 Solution Name, blank to skip station
programming
[0232] 18. Station #7 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0233] 19. Station #7 Solution Name, blank to skip station
programming
[0234] 20. Station #8 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0235] 21. Station #8 Solution Name, blank to skip station
programming
[0236] 22. Station #9 Volume: value can be 0, 5.0 to 99.9, or 100
to 5000 mL
[0237] 23. Station #9 Solution Name, blank to skip station
programming
[0238] Exemplary barcode content for a non-limiting example of a
TPN order is listed below and an exemplary barcodes 2300 is
illustrated in FIG. 23A.
[0239] O,L,111-11-1111,RX12345-Abc,0001,250,FreAmine 15%,180,
[0240] Dextrose 50%,55.5,Hyperlyte CR,,,,,,,,,,,450,Sterile
Water
[0241] It is also contemplated that other types of labels may be
implemented to carry out the present invention, such as RFID tags.
In such an implementation, the RFID tag includes the information
outlined above and may be accessed using conventional RFID
activation systems. Such systems transmit and RF signal to the RFID
tag in order to activate the tag, which in turn transmits its
information to a local receiver, normally incorporated within the
RFID activation system.
[0242] Barcode Explanation:
[0243] Although the following is directed to bar coded embodiments,
it is equally applicable to an RFID implementation.
[0244] The entire barcode should desirably be one line (do not
include carriage returns within the line, but a carriage return
should be present at the end of the line). [0245] The first 2
fields identify the barcode and specify a (L)ocked order. Since the
order is "locked", it is prevented from being modified by the
pharmacy technician and can only be compounded as originally
ordered. [0246] The Patient ID is `111-11-1111`. [0247] The Order
ID is `RX12345-Abc`.
[0248] The Bag ID is `0001`. [0249] Station 1 will be programmed
for 250 mL of FreAmine 15%. [0250] Station 2 will be programmed for
180 mL of Dextrose 50%. [0251] Station 3 will be programmed for
55.5 mL of Hyperlyte CR. [0252] Stations 4 through 8 will not be
changed. [0253] Station 9 will be programmed for 450 mL of Sterile
Water.
[0254] Exemplary barcode content for a non-limiting example of a
Library Formula or Quick Setup is listed below and an exemplary two
dimensional barcode 2300 is illustrated in FIG. 23B.
[0255] Barcode Content:
[0256] O,,,,,0,FreAmine 15%,0,Dextrose 50%,0,Hyperlyte CR,0,
Trophamine 10%,0,FreAmine HBC 6.9%,0, Dex 5%/0.2% NaCl,0, Liposyn
30%,0, Tham 0.3 Molar Sol,0,Sterile Water
[0257] Barcode Explanation:
[0258] The entire barcode should desirably be one line (do not
include carriage returns). [0259] The first field identifies the
barcode. [0260] The order is allowed to be manually adjusted after
loading. No Patient ID is specified. [0261] No Order ID is
specified (so it will be automatically recorded as `Manual ###`).
[0262] No Bag ID is specified. [0263] Station 1 will be programmed
for FreAmine 15%. [0264] Station 2 will be programmed for Dextrose
50%. [0265] Station 3 will be programmed for Hyperlyte CR. [0266]
Station 4 will be programmed for Trophamine 10%. [0267] Station 5
will be programmed for FreAmine HBC 6.9%. [0268] Station 6 will be
programmed for Dex 5%/0.2% NaCl. [0269] Station 7 will be
programmed for Liposyn 30%. [0270] Station 8 will be programmed for
Tham 0.3 Molar Sol. [0271] Station 9 will be programmed for Sterile
Water. [0272] All station volumes will be reset to zero.
[0273] Alternately, the code may contain all pertinent information
such as solution name and volume information, but may lack
information with respect to specific stations into which the source
solution is to be placed. In this example, the Compounder would
determine any new or already existing source solution placements
with those contained in the bar coded prescription order.
[0274] After the barcode label is printed, it is physically
transferred to location where the compounder, such as compounding
system 10, is located. Referring again to FIG. 1, barcode label
2216 may desirably be attached to a final solution container 14
intended to contain the desired compound. By attaching the barcode
label to the solution container before compounding begins, errors
may be minimized. Next, the barcode label 2216 of final solution
container 14 is scanned into system 10 using barcode scanner 82. As
discussed above with respect to the compounding system 10
embodiments, the system will direct the operator to install the
correct source solutions to the appropriate stations before
allowing compounding to begin. Once compounding is complete, system
10 may optionally produce another barcode label, such as that
illustrated in FIG. 24, in which a compounding summary 2400 is
contained. As shown in FIG. 24, a non-limiting example of
compounding summary 2400 includes Order ID 2402, Operator
information 2404, Start Time 2406, Job Time 2408, Job Status 2410,
and details of the solution 2412. Additionally result barcode 2414
is included which contains all information necessary to verify that
the solution in container 14 is as intended.
[0275] Used in conjunction with the Order barcode 2300, the Result
barcode 2414 provides another way to move information reliably. As
mentioned above, result barcode 2414 is printed on the compounding
summary page, in any desired location. Result barcode 2414 contains
basically the same information as the compounding summary header,
which includes the compounding order identification, compounding
date and time, and the compounding result code.
[0276] Examples of Result barcode fields are as follows:
[0277] 1. "R"=Barcode Identifier Code.
[0278] 2. Result Code: (C)ompleted, (A)borted, (F)ailed (see notes
below).
[0279] 3. Patient ID, maximum of 12 characters.
[0280] 4. Order ID, maximum of 30 characters.
[0281] 5. Bag ID, maximum of 12 characters.
[0282] 6. Compounding Date, "mm/dd/yyyy" format.
[0283] 7. Compounding Time, "hh:mm" format (24 hour).
Note--The result code for a compounding operation can be one of the
following:
[0284] "C"--Completed successfully.
[0285] "A"--Aborted by operator.
[0286] "F"--Failed due to unrecoverable delivery error.
[0287] Verification of the solution in container 14 is simply
conducted by scanning barcode label 2414 and comparing the
information contained therein with the information in the system
based on either the memory of the initially scanned barcode label
2300 or the patient record. In one exemplary embodiment, result
barcode 2414 may be scanned into compounding system 10 for
comparison with the information contained in barcode label 2300.
Alternatively, and/or additionally, result barcode 2414 may be
scanned by personnel before administering the compound to the
patient using scanner 2210 of system 2200 (see. FIG. 22). If an
error is detected in the comparison, the operator is alerted so
that corrective measures can be taken, such as recreating the
compound or conducting self-test of the systems. If the comparison
is successful the operator may be notified as well.
[0288] Although examples discussed above may relate to a bar code
system, the invention is not so limited in that, as identified
above, RFID tags may be used as a means to convey compounding
information to the compounder and compound solution information
from the compounder system back to the ordering system of other
check point to verify compliance.
[0289] Features of the invention are set forth in the following
claims.
[0290] Although the invention is illustrated and described herein
with reference to specific embodiments, the invention is not
intended to be limited to the details shown. Rather, various
modifications may be made in the details within the scope and range
of equivalents of the claims and without departing from the
invention.
* * * * *