U.S. patent application number 15/796655 was filed with the patent office on 2018-02-22 for patient-based results display.
The applicant listed for this patent is Bio-Rad Laboratories, Inc.. Invention is credited to Adam Darmstadt, Theresa Forni, Michael Waite.
Application Number | 20180052148 15/796655 |
Document ID | / |
Family ID | 50433353 |
Filed Date | 2018-02-22 |
United States Patent
Application |
20180052148 |
Kind Code |
A1 |
Darmstadt; Adam ; et
al. |
February 22, 2018 |
PATIENT-BASED RESULTS DISPLAY
Abstract
A medical testing machine provides improved recall and display
of the outcomes of tests performed by the machine. Test outcomes
and other information are stored in mass storage directly
accessible by the medical testing machine. In one aspect, outcomes
of tests relating to a particular patient may be recalled. The
system may be especially useful for tests that may be performed
multiple times for a particular patient over a period of time, for
example testing for HbA1c hemoglobin levels in diabetes patients.
According to another aspect, the medical testing machine may store
an accession number for each test outcome, and may enable a user to
display as a group test outcomes having the same accession number.
The system may store further information and associate it with
particular test outcomes, for example calibration information. The
system may also store a set of rules under which each test instance
was run.
Inventors: |
Darmstadt; Adam; (Dublin,
CA) ; Waite; Michael; (Pinole, CA) ; Forni;
Theresa; (Davis, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bio-Rad Laboratories, Inc. |
Hercules |
CA |
US |
|
|
Family ID: |
50433353 |
Appl. No.: |
15/796655 |
Filed: |
October 27, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14048305 |
Oct 8, 2013 |
9804149 |
|
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15796655 |
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61712164 |
Oct 10, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G01N 2035/00831
20130101; G01N 33/49 20130101; G01N 35/00732 20130101; G01N
35/00603 20130101; G16H 10/40 20180101 |
International
Class: |
G01N 33/49 20060101
G01N033/49; G06F 19/00 20060101 G06F019/00; G01N 35/00 20060101
G01N035/00 |
Claims
1. A medical testing machine, comprising: an input location, an
output location, and a vial handling mechanism that moves vials of
media sampled from patients from the input location through the
testing machine to the output location; an extraction mechanism
that extracts the media from each vial in turn for testing; a
testing system that performs a medical test on the media sampled
from patients, each test instance having an outcome; a reader that
obtains, for each of a plurality of test instances, an identifier
of the particular patient from which the media was sampled by
reading the identifier from a container that holds the media; a
processor that receives the output of the sensor and determines the
outcome for each respective test and that causes test outcomes to
be stored in a mass storage memory in association with their
respective patient identifiers; and a computerized retrieval system
that enables a user to specify a particular patient identifier and
causes the computerized retrieval system to retrieve from the mass
storage memory test outcomes associated with the particular patient
identifier.
2. The medical testing machine of claim 1, wherein the testing
system comprises a high performance liquid chromatography system
including a column holding a stationary medium, the high
performance liquid chromatography system separating components of
the sampled media as the sampled media flows through the column,
and the high performance liquid chromatography system including a
sensor that senses indications that the separated components are
passing the sensor.
3. The medical testing machine of claim 1, further comprising an
electronic display on which the retrieved outcomes are shown.
4. The medical testing machine of claim 3, wherein the electronic
display is a touchscreen display and also serves as an input device
for receiving inputs from the user.
5. The medical testing machine of claim 1, further comprising the
mass storage memory.
6. The medical testing machine of claim 1, wherein the mass storage
memory is remote from the medical testing machine and is accessible
via a computer network.
7. The medical testing machine of claim 1, wherein the reader
further obtains for each test instance an accession number of the
respective sample.
8. The medical testing machine of claim 7, further comprising a
user interface control that causes test outcomes having the same
accession number to be shown in a group on the display.
9. The medical testing machine of claim 8, wherein the test
outcomes having the same accession number are shown in the group on
the electronic display regardless of whether one or more of the
grouped test outcomes would otherwise be omitted from being shown
on the electronic display by a data filter in place at the time the
user interface control is actuated.
10. The medical testing machine of claim 1, wherein the
computerized retrieval system enables multiple levels of detail to
be shown about each test instance outcome.
11. The medical testing machine of claim 1, wherein the mass
storage memory also stores in association with each test instance
outcome information about the state of the medical testing machine
at the time the particular test instance was run.
12. The medical testing machine of claim 11, wherein the stored
state information includes a set of rules used to evaluate test
outcomes for validity.
13. The medical testing machine of claim 12, further comprising a
user interface control that causes to be displayed, for a
particular test instance, the rules in place at the time the
particular test instance was run.
14. The medical testing machine of claim 1, further comprising an
electronic display, wherein during a particular test instance, an
animated counter counts down the time remaining until the test is
completed.
15. The medical testing machine of claim 14, wherein the electronic
display further shows a rack number and position within the rack of
a container from which media was extracted for running the
particular test instance.
16. The medical testing machine of claim 14, wherein the electronic
display further shows levels of consumable materials remaining in
the medical testing machine.
17. A medical testing machine, comprising: an input location, an
output location, and a vial handling mechanism that moves vials of
media sampled from patients from the input location through the
testing machine to the output location; an extraction mechanism
that extracts the media from each vial in turn for testing; a
testing system that performs a medical test on media sampled from
patients, each test instance having an outcome; a reader that
obtains, for each of a plurality of test instances, an accession
number of the particular media sample by reading the accession
number from a container that holds the media; a processor that
receives the output of the sensor and determines the outcome for
each respective test and that causes each test outcome to be stored
in a mass storage memory in association with its respective
accession number; and a computerized retrieval system that enables
a user to specify a particular accession number and cause the
computerized retrieval system to display as a group all of the
stored test outcomes having the same accession number.
18. The medical testing machine of claim 17, wherein the testing
system comprises a high performance liquid chromatography system
including a column holding a stationary medium, the high
performance liquid chromatography system separating components of
the sampled media as the sampled media flows through the column,
and the high performance liquid chromatography system including a
sensor that senses indications that the separated components are
passing the sensor.
19. The medical testing machine of claim 17, wherein the test
outcomes having the same accession number are displayed as a group
regardless of whether one or more of the grouped test outcomes
would otherwise be omitted from being displayed by a data filter in
place at the time the group display is requested.
20. The medical testing machine of claim 17, wherein the mass
storage also stores in association with each test instance outcome
information about the state of the medical testing machine at the
time the particular test instance was run.
21. The medical testing machine of claim 20, wherein the stored
state indication includes a set of rules used to evaluate test
outcomes for validity.
22. The medical testing machine of claim 17, further comprising an
electronic display, wherein during a particular test instance, an
animated counter counts down the time remaining until the test is
completed.
23. A medical testing machine, comprising: an input location, an
output location, and a vial handling mechanism that moves vials of
media sampled from patients from the input location through the
testing machine to the output location; an extraction mechanism
that extracts the media from each vial in turn for testing; a
testing system that performs a medical test on media sampled from
patients, each test instance having an outcome; a processor that
receives the output of the sensor and determines the outcome for
each respective test and that causes test outcomes to be stored in
a mass storage memory in association with their respective patient
identifiers; and a computerized retrieval system that enables a
user to specify a particular filter criterion and cause the
computerized retrieval system to retrieve from the mass storage
memory test outcomes meeting the filter criterion; wherein the mass
storage memory also stores in association with each test instance
outcome information about the state of the medical testing machine
at the time the particular test instance was run.
24. The medical testing machine of claim 23, wherein the testing
system comprises a high performance liquid chromatography system
including a column holding a stationary medium, the high
performance liquid chromatography system separating components of
the sampled media as the sampled media flows through the column,
and the high performance liquid chromatography system including a
sensor that senses indications that the separated components are
passing the sensor.
25. The medical testing machine of claim 23, wherein the stored
state information includes a set of rules used to evaluate test
outcomes for validity.
26. The medical testing machine of claim 25, further comprising a
user interface control that causes to be displayed, for a
particular test instance, the rules in place at the time the
particular test instance was run.
27. A method, comprising: receiving vials of media sampled from
patients at an input location of a medical testing machine; moving
the received vials through the medical testing machine to an output
location of the medical testing machine; extracting the media from
each vial in turn for testing; separating components of the sampled
media using high performance liquid chromatography, wherein
separating the components comprises passing the sampled media
through a stationary medium; sensing the passage of the separated
components using a sensor; recording an outcome of each respective
test in a computerized system; accessing, using the computerized
system, an electronic library of the test outcomes obtained from
the performance of the high performance liquid chromatography on
the media samples; identifying in the library one or more sets of
the test outcomes in which each outcome in a respective set results
from testing of the same respective media sample; and displaying as
a group the outcomes in at least one set.
28. The method of claim 27, wherein identifying one or more sets of
the test outcomes in which each outcome in a respective set results
from testing of the same respective media sample comprises
identifying sets of test outcomes having a same accession
number.
29. The method of claim 27, wherein the test outcomes in a set are
displayed as a group regardless of whether one or more of the
grouped test outcomes would otherwise be omitted from being
displayed by a data filter in place at the time the group display
is requested.
30. The method of claim 27, wherein the library of test outcomes is
stored in a testing machine used to perform the medical test.
31. The method of claim 27, wherein the library of test outcomes is
stored separately from a testing machine used to perform the
medical test.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and is a continuation of
U.S. application Ser. No. 14/048,305, filed Oct. 8, 2013 and titled
"Patient-Based Results Display," which claims the benefit of U.S.
Provisional Application No. 61/712,164, filed Oct. 10, 2012 and
titled "Patient-Based Results Display," the entire disclosures of
which are herein incorporated by reference for all purposes.
BACKGROUND OF THE INVENTION
[0002] In the diagnosis and monitoring of diseases, medical tests
are often performed on blood, tissue, or other media sampled from
patients. In a typical scenario, a doctor requests that a
particular test be performed, and a sample is taken from the
patient. The sample is sent to an on-site or off-site testing lab,
and the results of the test are returned to the doctor for review
and reporting to the patient. The test results are also typically
placed in the patient's file.
[0003] Some conditions require ongoing monitoring. In these cases,
tests may be performed multiple times for a particular patient.
BRIEF SUMMARY OF THE INVENTION
[0004] According to one aspect, a medical testing machine comprises
an input location, an output location, and a vial handling
mechanism that moves vials of media sampled from patients from the
input location through the testing machine to the output location.
The medical testing further includes an extraction mechanism that
extracts the media from each vial in turn for testing, a testing
system that performs a medical test on the media sampled from
patients, each test instance having an outcome, and a reader. The
reader obtains, for each of a plurality of test instances, an
identifier of the particular patient from which the media was
sampled by reading the identifier from a container that holds the
media. The medical testing machine further comprises a processor
that receives the output of the sensor and determines the outcome
for each respective test and that causes test outcomes to be stored
in a mass storage memory in association with their respective
patient identifiers, and a computerized retrieval system that
enables a user to specify a particular patient identifier and cause
the computerized retrieval system to retrieve from the mass storage
memory test outcomes associated with the particular patient
identifier. In some embodiments, the testing system comprises a
high performance liquid chromatography system including a column
holding a stationary medium, the high performance liquid
chromatography system separating components of the sampled media as
the sampled media flows through the column, and the high
performance liquid chromatography system including a sensor that
senses indications that the separated components are passing the
sensor. In some embodiments, the medical testing machine further
comprises an electronic display on which the retrieved outcomes are
shown. In some embodiments, the electronic display is a touchscreen
display and also serves as an input device for receiving inputs
from the user. In some embodiments, the medical testing machine
further comprises the mass storage memory. In some embodiments, the
mass storage memory is remote from the medical testing machine and
is accessible via a computer network. In some embodiments, the
reader further obtains for each test instance an accession number
of the respective sample. In some embodiments, the medical testing
machine further comprises a user interface control that causes test
outcomes having the same accession number to be shown in a group on
the display. In some embodiments, the test outcomes having the same
accession number are shown in the group on the electronic display
regardless of whether one or more of the grouped test outcomes
would otherwise be omitted from being shown on the electronic
display by a data filter in place at the time the user interface
control is actuated. In some embodiments, the computerized
retrieval system enables multiple levels of detail to be shown
about each test instance outcome. In some embodiments, the mass
storage memory also stores in association with each test instance
outcome information about the state of the medical testing machine
at the time the particular test instance was run. In some
embodiments, the stored state information includes a set of rules
used to evaluate test outcomes for validity. In some embodiments,
the medical testing machine further comprises a user interface
control that causes to be displayed, for a particular test
instance, the rules in place at the time the particular test
instance was run. In some embodiments, the medical testing machine
further comprises an electronic display, wherein during a
particular test instance, an animated counter counts down the time
remaining until the test is completed. In some embodiments, the
electronic display further shows a rack number and position within
the rack of a container from which media was extracted for running
the particular test instance. In some embodiments, the electronic
display further shows levels of consumable materials remaining in
the medical testing machine.
[0005] According to another aspect, a medical testing machine
comprises an input location, an output location, and a vial
handling mechanism that moves vials of media sampled from patients
from the input location through the testing machine to the output
location. The medical testing machine further comprises an
extraction mechanism that extracts the media from each vial in turn
for testing, a testing system that performs a medical test on media
sampled from patients, each test instance having an outcome, and a
reader. The reader obtains, for each of a plurality of test
instances, an accession number of the particular media sample by
reading the accession number from a container that holds the media.
The medical testing machine further includes a processor that
receives the output of the sensor and determines the outcome for
each respective test and that causes each test outcome to be stored
in a mass storage memory in association with its respective
accession number, and a computerized retrieval system that enables
a user to specify a particular accession number and cause the
computerized retrieval system to display as a group all of the
stored test outcomes having the same accession number. In some
embodiments, the testing system comprises a high performance liquid
chromatography system including a column holding a stationary
medium, the high performance liquid chromatography system
separating components of the sampled media as the sampled media
flows through the column, and the high performance liquid
chromatography system including a sensor that senses indications
that the separated components are passing the sensor. In some
embodiments, the test outcomes having the same accession number are
displayed as a group regardless of whether one or more of the
grouped test outcomes would otherwise be omitted from being
displayed by a data filter in place at the time the group display
is requested. In some embodiments, the mass storage also stores in
association with each test instance outcome information about the
state of the medical testing machine at the time the particular
test instance was run. In some embodiments, the stored state
indication includes a set of rules used to evaluate test outcomes
for validity. In some embodiments, the medical testing machine
further comprises an electronic display, wherein during a
particular test instance, an animated counter counts down the time
remaining until the test is completed.
[0006] According to another aspect, a medical testing machine
comprises an input location, an output location, and a vial
handling mechanism that moves vials of media sampled from patients
from the input location through the testing machine to the output
location. The medical testing machine further includes an
extraction mechanism that extracts the media from each vial in turn
for testing, a testing system that performs a medical test on media
sampled from patients, each test instance having an outcome, and a
processor. The processor receives the output of the sensor and
determines the outcome for each respective test and that causes
test outcomes to be stored in a mass storage memory in association
with their respective patient identifiers. The medical testing
machine further comprises a computerized retrieval system that
enables a user to specify a particular filter criterion and cause
the computerized retrieval system to retrieve from the mass storage
memory test outcomes meeting the filter criterion. The mass storage
memory also stores in association with each test instance outcome
information about the state of the medical testing machine at the
time the particular test instance was run. In some embodiments, the
testing system comprises a high performance liquid chromatography
system including a column holding a stationary medium, the high
performance liquid chromatography system separating components of
the sampled media as the sampled media flows through the column,
and the high performance liquid chromatography system including a
sensor that senses indications that the separated components are
passing the sensor. In some embodiments, the stored state
information includes a set of rules used to evaluate test outcomes
for validity. In some embodiments, the medical testing machine
further comprises a user interface control that causes to be
displayed, for a particular test instance, the rules in place at
the time the particular test instance was run.
[0007] According to another aspect, a method comprises receiving
vials of media sampled from patients at an input location of a
medical testing machine, moving the received vials through the
medical testing machine to an output location of the medical
testing machine, extracting the media from each vial in turn for
testing, and separating components of the sampled media using high
performance liquid chromatography, wherein separating the
components comprises passing the sampled media through a stationary
medium. The method further comprises sensing the passage of the
separated components using a sensor, recording an outcome of each
respective test in a computerized system, and accessing, using the
computerized system, an electronic library of the test outcomes
obtained from the performance of the high performance liquid
chromatography on the media samples. The method further comprises
identifying in the library one or more sets of the test outcomes in
which each outcome in a respective set results from testing of the
same respective media sample, and displaying as a group the
outcomes in at least one set. In some embodiments, identifying one
or more sets of the test outcomes in which each outcome in a
respective set results from testing of the same respective media
sample comprises identifying sets of test outcomes having a same
accession number. In some embodiments, the test outcomes in a set
are displayed as a group regardless of whether one or more of the
grouped test outcomes would otherwise be omitted from being
displayed by a data filter in place at the time the group display
is requested. In some embodiments, the library of test outcomes is
stored in a testing machine used to perform the medical test. In
some embodiments, the library of test outcomes is stored separately
from a testing machine used to perform the medical test.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 shows a medical testing machine in accordance with
example embodiments of the invention.
[0009] FIG. 2 shows a vial as may be used in the medical testing
machine of FIG. 1, in more detail.
[0010] FIG. 3 shows a simplified block diagram of the architecture
of the medical testing machine of FIG. 1, in accordance with
embodiments of the invention.
[0011] FIG. 4 shows an example user interface screen that may be
presented on a display, enabling a user to specify criteria by
which to recall stored test information in accordance with
embodiments of the invention.
[0012] FIG. 5 illustrates a second user interface screen, in
accordance with embodiments.
[0013] FIG. 6 shows an example embodiment of a more detailed report
screen.
[0014] FIG. 7 shows a user interface screen with a listing of test
outcomes, in accordance with embodiments of the invention.
[0015] FIG. 8 shows a display of related outcomes, in accordance
with embodiments of the invention.
[0016] FIG. 9 shows another user interface screen in accordance
with embodiments of the invention.
[0017] FIG. 10 shows another user interface screen in accordance
with embodiments of the invention.
[0018] FIG. 11 shows an example user interface window having
additional test details, in accordance with embodiments of the
invention.
[0019] FIG. 12 shows a display of a rules listing, in accordance
with embodiments of the invention.
[0020] FIG. 13 shows a user interface screen that provides status
information, in accordance with embodiments of the invention
DETAILED DESCRIPTION OF THE INVENTION
[0021] Embodiments of the invention provide improved access to
medical test results and documentation of the conditions under
which tests were performed. These techniques may be especially
applicable for tests that are performed repeatedly.
[0022] One example of a condition that requires ongoing monitoring
and repeated testing is diabetes. Diabetes is a name given to a
class of conditions in which a patient exhibits elevated blood
sugar levels, either because the patient's body does not produce
enough of the metabolism-regulating hormone insulin, or because
cells in the patient's body do not respond properly to insulin.
Diabetes is increasingly prevalent in the United States and other
parts of the world.
[0023] The management of diabetes often involves frequent blood
sugar measurements, and many patients use at-home blood sugar
testing devices to take frequent instantaneous readings of their
blood sugar levels.
[0024] The patient's average blood glucose level over long periods
of time, typically several months, is also reflected in the level
of HbA1c hemoglobin in the patient's blood. Testing for HbA1c
levels is more complex than testing for an instantaneous blood
sugar level, and can be done using high performance liquid
chromatography (HPLC) in a specialized testing machine. A patient
may be tested several times per year and the resulting measured
levels of HbA1c used as a check on how well the patient's blood
sugar levels are being controlled.
[0025] Because a particular patient may visit the same doctor or
clinic many times, the same testing machine may be used to test
blood from the patient over the course of many months or years.
Previously, this information was reported to the doctor and placed
in the patient's medical record. Obtaining a time history of test
results from the patient's medical record may be time consuming and
error-prone.
[0026] In some cases, it may be desirable to correlate a particular
test result with the conditions under which the test was run. For
example, it may be desired for a particular test to know how
recently the testing machine was calibrated before the test was
run, a batch number for consumables used in the test, and other
information. Previously, such a correlation would require searching
calibration logs and other records maintained by the testing
facility, and correlating them with patient records.
[0027] In embodiments of the invention, the testing machine itself
stores detailed records of tests, and enables retrieving test
results by patient identification number and other parameters. The
testing machine may also record maintenance and calibration
information, consumable item serial numbers, and other information
that enables efficient correlation of test conditions with patient
test results.
[0028] FIG. 1 shows a medical testing machine 100 in accordance
with example embodiments of the invention. While testing machine
100 is configured for testing blood samples for the level of HbA1c
hemoglobin, it will be understood that the principles of the
invention are applicable to testing machines used for other
purposes as well. Vials 101 containing blood sampled from patients
are loaded into racks 102, which are then placed into testing
machine 100 at input location 103. Vials 101 are examples of
containers for patient media, but in other kinds of tests, other
kinds of containers may be used. An automated testing system within
medical testing machine 100 extracts a quantity from each vial in
sequence, and for each sample performs HPLC to determine the level
of HbA1c in the blood. When all of the vials in a rack have been
tested, the rack is delivered out of the machine at output location
104. A "STAT input" 105 may be provided for initiating an
out-of-sequence test. Placing a vial in stat drawer 105 causes the
vial to be tested immediately, without having to wait for the vials
previously placed at input location 103 to be processed.
[0029] Test results and other information are shown on a display
screen 106, as is described in more detail below. Display screen
106 may be any suitable type of display, for example a flat panel
liquid crystal display (LCD). Display screen 106 may also include a
touchscreen, and serve as an input device for receiving inputs from
the user of medical testing machine 100.
[0030] HPLC by its nature uses certain consumable materials, for
example buffers and washing solution, and packets 107 of consumable
materials may be periodically replaced in medical testing machine
100. The stationary media used in HPLC may also be periodically
replaced.
[0031] FIG. 2 shows a vial 101 in more detail. Each vial 101 is
labeled with a machine-readable label 201 carrying information
about the sample. Many different label formats are possible.
Example label 201 includes a patient identifier 202, which may be
shown in human-readable form as well as in machine readable form
such as in barcode 203. Label 201 may also include an accession
number 204. For the purposes of this disclosure, an accession
number is any numeric, alphabetic, alphanumeric, symbolic, or other
identifier unique to a particular media sample. Example accession
number 204 is an identifier unique to the particular media in vial
101. In some cases, multiple vials 101 may have the same accession
number, as is explained in more detail below. Accession number 204
is also preferably shown in machine readable form such as in
barcode 203. Because a particular patient may visit the facility
where medical testing machine 100 is used multiple times (or
multiple samples from the patient may be sent to the facility),
over a period of time multiple vials 101 may be labeled with the
same patient number, but have unique accession numbers. In some
cases, the sample in a particular vial may be tested more than
once, as will be explained in more detail below.
[0032] FIG. 3 shows a simplified block diagram of the architecture
of medical testing machine 100, in accordance with embodiments of
the invention. A processor 301 generally controls the operation of
medical testing machine 100. Processor 301 may be any suitable kind
of microprocessor, microcontroller, digital signal processor, or
other circuitry capable of performing the required functions.
Memory 302 may include different kinds of memory, alone or in
combination, and stores a variety of digital information. For
example, memory 302 may include random access memory (RAM), read
only memory (ROM), re-writable non-volatile memory such as flash
memory, other kinds of memory, or any suitable combination thereof.
In particular, memory 302 includes mass storage 303 for
non-volatile storage of large quantities of information, for
example the results of tests performed by medical testing machine
100. Mass storage 303 may include magnetic disk storage, optical
disk storage, solid state memory, other kinds of storage, or any
suitable combination thereof
[0033] Memory 302 preferably holds instructions that, when executed
by processor 301, cause medical testing machine 100 to perform its
intended functions.
[0034] Medical testing machine 100 includes a vial handling
mechanism 304, for moving vials of patient samples through the
system for testing. A vial reader 305 reads information from vials
101. For example, vial reader 305 may be a barcode reader that
reads bar coded information such as patient and accession numbers
202 and 204 from a label such as label 201. In other embodiments, a
different mechanism may be provided for obtaining information about
a sample, for example a radio frequency identification (RFID)
scanner, optical character recognition, or another suitable
mechanism. In some embodiments, a user may enter information
manually.
[0035] An extraction mechanism 306 automatically, under control of
processor 301, extracts blood from each vial in turn for testing,
and delivers the samples to high performance liquid chromatography
(HPLC) system 307. In general, liquid chromatography involves
introducing a small quantity of the sampled blood into the flow of
a liquid medium, and passing the liquid medium through a stationary
medium. Different components of the introduced blood will traverse
the stationary medium at different speeds, due to their different
interactions with the liquid and stationary media. The stationary
medium is sometimes referred to as a "column", although the
stationary medium may not be arranged vertically. After a time,
different components of the introduced blood sample will become
separated within the column, and the separated components will
arrive at the end of the column at different times. A sensor 308
near the end of the column watches for indications that the
different components are passing. The indications may be
differences in color, refractive index, spectral absorption
characteristics, pH, or other characteristics. A brief overview of
chromatography is given in co-pending U.S. Provisional Patent
Application No. 61/559,399, the entire disclosure of which is
hereby incorporated by reference herein.
[0036] The output of sensor 308 passes to processor 301, which
determines the result of the test. Results may be shown on display
screen 106. Test results are stored in mass storage 303, in
association with other information such as the information read
from the vial labels. In particular, a particular test result is
stored in association with the patient identifier of the patient
from which the tested media was sampled. Other kinds of information
that are preferably included in the test information include the
raw sensor output from the test, the time and result of the most
recent calibration of medical testing machine 100, serial numbers
or other identifying information about the consumable items used in
the test, and any retest rules that were in place at the time of
the test. Other kinds of information may also be stored. For
example, as is explained in more detail below, a particular test
may not produce a numerical result, because of a problem with the
sample or an irregularity in the particular test. In this
situation, the outcome of the test may be that there is no
numerical result to report. For the purposes of this disclosure,
the term "outcome" encompasses test outcomes with or without
numerical results.
[0037] While mass storage 303 is depicted in FIG. 3 as being
internal to medical testing machine 100, other arrangements are
possible, and it is intended that the appended claims encompass
other arrangements. For example, mass storage 303 may be external
to medical testing machine 100 and connected to medical testing
machine 100 by a cable or wireless interface. In some embodiments,
mass storage 303 may be in a different location than medical
testing machine 100 and connected to medical testing machine 100
through a computer network.
[0038] Over time, a particular testing machine 100 may perform many
thousands of individual tests, accumulating the test outcomes in
mass storage 303. Some patients may undergo multiple tests, so that
the accumulated library of data in mass storage 303 will include
instances where multiple tests have the same patient identifiers.
This collection of information enables a user to conveniently and
quickly produce reports that have previously been difficult to
produce.
[0039] For example, testing machine 100 may enable retrieval of
test results and other information according to one or more
filters. FIG. 4 shows an example user interface screen 400 that may
be presented on display screen 106, enabling a user to specify
criteria by which to recall stored test information. Among the
criteria that may be used to retrieve stored test data is the
patient identifier, as specified in area 401 of screen 400. In this
example, the patient can be identified by a patient ID number such
as may be assigned by a particular health care facility, by name,
by date of birth, or by other information or combination of
information. The retrieval of results and other information is
preferably performed under the control of processor 301, and is
thus performed by a computerized retrieval system.
[0040] In the example of FIG. 4, a user has entered a patient ID
number. Once the user indicates that the information is to be
retrieved, for example by touching the "Apply Filter" location on
user interface screen 400, a second user interface screen may be
shown.
[0041] FIG. 5 illustrates a second user interface screen 500, in
accordance with embodiments. Screen 500 shows four test results
that have been retrieved relating to patient 33333. In this
example, patient 33333 has visited the clinic three times in the
span of about six months. On the patient's second visit, the first
attempt at testing the patient's blood sample was judged to be
possibly erroneous, and the sample was tested a second time.
Repeated tests are discussed in more detail below. The report shown
in user interface screen 500 has been produced by medical testing
machine 100, using data stored by and accessible to medical testing
machine 100, and is thus produced quickly and efficiently.
[0042] In some embodiments, additional detail about each test
instance is stored, and can be retrieved for more detailed
analysis. For example, a user may indicate that a more detailed
report is desired for one of the test instances listed in FIG. 5.
The indication may be done in any suitable way, such as touching or
tapping twice on display screen 106 over the displayed record.
[0043] FIG. 6 shows an example of a more detailed report screen
600. The detailed report screen may include such information as a
chromatogram 601 of the output of sensor 308. In FIG. 6, a peak 602
identified as representing HbA1c in the patient's blood has been
highlighted in chromatogram 601. Tabular information 603 may also
be presented, showing peaks identified in the output of sensor 308,
and the corresponding blood components if known. Many other kinds
of information could be presented.
[0044] In example report screen 600, the results presented in user
interface screen 500 are also shown, but may be in a condensed
format 604. In this example, only two tests from interface screen
500 are shown at a time, but the complete listing is accessible
using a scrolling bar 605 or other suitable control, such as
navigation buttons.
[0045] According to another aspect, embodiments of the invention
facilitate display and investigation of repeated tests. In this
context, a repeated test occurs when the same sampling of patient
media is tested more than once. Repeated tests can occur for any of
a variety of reasons. For example, at the time a patient's blood is
drawn, the phlebotomist may draw more than one vial of blood, in
anticipation that more than one vial will be needed to supply all
of the tests ordered for the patient. All of the vials will be
labeled with the same patient identifier and/or accession number.
Even though only one vial may be needed for a particular test, more
than one vial may be inadvertently placed in testing machine 100,
resulting in multiple test results having the same patient
identifier and accession number. After the first, any subsequent
test results will be marked as repeated results. Preferably, the
first result will also be marked as having been repeated, as is
illustrated by icon 606 shown in FIG. 6. In another example,
repeated tests can occur even if only one vial of blood is drawn.
One way this can occur is that the first test on the vial is
irregular in some way. Testing machine 100 may be programmed with a
set of rules by which test results are evaluated for validity or
other purposes. The rules may reflect expected characteristics of
the particular test being evaluated. In one example, testing
machine 100 may expect that the area under the curve of peak 602
will fall within a certain range. If the area measured in a
particular test falls outside the expected range, testing machine
100 may automatically repeat the test, on the assumption that some
problem occurred during the test that could be corrected by a
retest. For example, if extraction mechanism 306 failed to extract
sufficient blood from a particular vial, resulting in a low area
for peak 602, a re-test may be successful in extracting a better
sample. In other cases, a technician operating testing machine 100
may cause a vial to be retested.
[0046] The results of repeated test may be of particular interest,
in evaluating a patient's testing history, in verifying proper
testing machine functioning, and for other purposes. According to
embodiments, testing machine 100 provides the capability to group
sets of repeated tests for display and investigation.
[0047] FIG. 7 shows a user interface screen 700 with a listing of
test results, in accordance with embodiments of the invention. In
this example, the presented list has been filtered to show only
results having HbA1c readings within a narrow range, but
embodiments of the invention may work with lists filtered in any
other way or not filtered at all. Thus, the example list of FIG. 7
shows results from any different patients and many different vials.
Some of the tests shown in the list are repeats of earlier tests,
but the related tests may not necessarily show in the list if their
results do not meet the current filter criteria. For example, test
701 in FIG. 7 is recognizable as repeat test 501 shown in FIG. 5,
but the corresponding test 502 does not appear in FIG. 7, because
test 502 did not fit the filter criteria used to generate the list
in FIG. 7. Another repeat test 702 also shows in FIG. 7.
[0048] A user of testing machine 100 may wish to investigate the
circumstances of the repeat tests in more detail. By pressing icon
703, the user can cause all of the related tests to be displayed,
as shown in user interface screen 800 of FIG. 8. Other kinds of
user interface controls for causing a display of related repeat
tests may be used as well.
[0049] In FIG. 8, test result 702 and its related tests 801 and 802
have been snapped to the top of the displayed list and highlighted
to emphasize that they are related repeat tests. This view reveals
that test 702 was a repeat of test 801, and was again repeated in
test 802, and that the three tests all have the same accession
number. This indicates that three vials from the same blood draw
were placed into testing machine 100, likely unnecessarily. The
HbA1c readings are very similar for all three, but two of the tests
fell below the screening level used to generate the list in FIG.
7.
[0050] Referring again to FIG. 7, should the user touch icon 704, a
user interface screen such as screen 900 shown in FIG. 9 would
appear, revealing that test 701 (501) was a repeat of test 502
necessitated by the fact that a problem was detected with test 502.
The user can get additional details in a manner similar to getting
additional details from a test in user interface screen 500. For
example, by tapping twice on test 501 in screen 900, or using some
other user interface control, the user can call up a detail screen
such as user interface screen 1000 shown in FIG. 10. Screen 1000
reveals that chromatogram 1001 is unusually low in amplitude, such
that the integrated area of not only the HbA1c peak but of the
entire chromatogram is low. This indicates a possible problem with
extraction of the sample, and not merely a low HbA1c reading for
the patient.
[0051] As before, medical testing machine 100 can provide grouped
results and result details because it maintains searchable records
of tests it performs. Reports and screens such as those shown in
FIGS. 7-10 can be produced quickly and easily, without a laborious
search of patient files.
[0052] According to another aspect, medical testing machine 100 may
provide detail about the state of medical testing machine 100 at
the time of any particular test. This capability provides
traceability for test results, and may facilitate documentation of
laboratory procedures as required by regulation. The level of
detail available may be extensive, including calibration records,
rules governing repeat testing, batch numbers of consumable items,
and other information.
[0053] In example user interface screen 1000, a screen location
1002 labeled "More Details" is provided. The user may touch or tap
twice on this simulated button to access configuration data and
other details indicating the state of testing machine 100 at the
time the currently displayed test outcome was obtained (from test
502 in this example).
[0054] FIG. 11 shows an example user interface window 1100 having
additional test details. Other formats and information content may
be used. In this example, window 1100 is a pop-up window overlaid
on user interface screen 1000, but other kinds of user interface
techniques may be used.
[0055] User interface window 1100 also provides a screen location
1101 labeled "View Rules". The user may touch this simulated button
to access a listing of the rules that were in place at the time of
the test for deciding when retests are necessary and the like. The
rules listing may be presented on a user interface screen such as
user interface screen 1200 shown in FIG. 12.
[0056] Example user interface screen 1200 is a pop-up window
overlaid on user interface screen 1000 and window 1100, but other
kinds of user interface techniques may be used. Because the rules
information is stored and accessed by medical testing machine 100,
it can be recalled quickly and easily, without the need to consult
calibration logs or other paper documentation. Other user interface
screens may enable a user to modify the rule set, and after each
modification, subsequent tests are automatically associated with
the rule set in place at the time of each test. Similarly,
calibrations times are automatically noted and associated with
subsequent tests.
[0057] According to another aspect, a medical testing machine
according to embodiments provides enhanced status information to
the user of the machine about the progress of testing. For example,
medical testing machine may require as much as 45 to 90 seconds to
process each vial. In order to plan his or her activities in the
testing lab, a user of medical testing machine 100 may wish to know
when a particular test will complete, when medical testing machine
100 will be ready to accept more racks of vials for testing, or
other information about the testing status.
[0058] FIG. 13 shows a user interface screen 1300 that provides
status information, in accordance with embodiments of the
invention. User interface screen 1300 may show on display screen
106 while testing is in progress. In example screen 1300, the
current rack number and position 1301 of the vial being processed
are displayed, enabling the user to quickly determine how long it
may be until more samples will need to be loaded into testing
machine 100. An animated counter 1302 counts down the time
remaining in the test currently underway. An arrow 1303 or shaded
feature may rotate around counter 1302 to indicate that testing is
progressing. For example, arrow 1303 may rotate about once per
second, or at another suitable speed.
[0059] User interface screen 1300 also shows at 1304 the current
levels of consumable materials remaining in testing machine 100,
for example buffers and wash solution, and also indicates at 1305
how much of the expected life of the stationary media has been
used.
[0060] While embodiments of the invention have been described above
in the context of a machine that tests blood for levels of HbA1c
hemoglobin using HPLC, it is to be understood that the claims are
not so limited, and that the principles of the invention may be
embodied in other kinds of testing machines that perform different
tests on other fluids, tissue, or other patient media. It is to be
understood that all workable combinations of the features and
capabilities described herein are also considered to be disclosed.
For example, medical testing machine embodying the invention may
include any one, any combination, or all of the features and
capabilities described above.
[0061] The invention may also be embodied in a system or method
that operates independently of any particular testing machine. For
example, a health care facility may store patient records in
electronic form, including the outcomes of tests performed by one
or more testing machines. This library of test outcomes can include
one or more sets of the test outcomes in which each outcome in a
respective set results from testing of the same respective media
sample. The facility may use a computerized retrieval system
separate from any particular testing machine to retrieve the test
outcomes. As in a method performed by the example testing machine
discussed above, the system can identify such sets and display the
outcomes in each set as a group. The sets may be recognized as
having a common accession number, or by other techniques. The test
outcomes in a set may displayed as a group regardless of whether
one or more of the grouped test outcomes would otherwise be omitted
from being displayed by a data filter in place at the time the
group display is requested. Such a method may be applied to the
outcomes of a test that measures the level of HbA1c hemoglobin in
blood, or the outcomes of other tests.
[0062] The invention has now been described in detail for the
purposes of clarity and understanding. However, it will be
appreciated that certain changes and modifications may be practiced
within the scope of the appended claims.
* * * * *