U.S. patent application number 11/639586 was filed with the patent office on 2007-06-21 for automated lean methods in anatomical pathology.
Invention is credited to Brian H. Kram, Randy Stephens.
Application Number | 20070141711 11/639586 |
Document ID | / |
Family ID | 38009245 |
Filed Date | 2007-06-21 |
United States Patent
Application |
20070141711 |
Kind Code |
A1 |
Stephens; Randy ; et
al. |
June 21, 2007 |
Automated lean methods in anatomical pathology
Abstract
An embodiment of the method of the invention is a method of
automating information flow in a laboratory performing tissue
staining comprising positioning a networked label printer adjacent
to a cutting station, the printer configured to access patient data
directly or indirectly from the hospital LIS, the printer being
configured with a data element scanner in electronic communication
with said printer; inputting data from a tissue cassette-associated
data element at said printer, whereby inputting data comprises
reading the data from the cassette-associated data element and
uploading the cassette data to the LIS; identifying the
corresponding test protocol identifier and then downloading the
test protocol data to the printer; printing information on labels
corresponding to each test specified in the LIS for the patient;
attaching a single label to each slide; and cutting a tissue
section for each labeled slide and mounting the section on the
slide.
Inventors: |
Stephens; Randy; (Honey
Grove, TX) ; Kram; Brian H.; (Tucson, AZ) |
Correspondence
Address: |
MUIRHEAD AND SATURNELLI, LLC
200 FRIBERG PARKWAY
SUITE 1001
WESTBOROUGH
MA
01581
US
|
Family ID: |
38009245 |
Appl. No.: |
11/639586 |
Filed: |
December 15, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60751807 |
Dec 19, 2005 |
|
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Current U.S.
Class: |
436/43 |
Current CPC
Class: |
G01N 35/00722 20130101;
G01N 1/286 20130101; G01N 2001/2873 20130101; G01N 1/06 20130101;
G01N 2035/00861 20130101; Y10T 436/11 20150115; G01N 2035/00881
20130101; G01N 1/312 20130101 |
Class at
Publication: |
436/043 |
International
Class: |
G01N 35/00 20060101
G01N035/00 |
Claims
1. A method of automating information associated with tissue
samples to be stained in a tissue staining laboratory comprising
the steps of: a. positioning a networked label printer adjacent to
a cutting station, said printer configured to access patient data
directly or indirectly from the hospital LIS, said printer being
configured with a data element scanner in electronic communication
with said printer; b. reading cassette data from the
cassette-associated data element and uploading said cassette data
to the LIS; c. identifying the corresponding test protocol
identifier and then downloading said test protocol data to said
printer; d. printing information on labels corresponding to each
test specified by the LIS for said patient; e. attaching a single
label to each slide; and f. cutting and mounting at least one
tissue section on each labeled slide.
2. A method of coordinating tissue sample information in a
laboratory staining process, comprising the steps of: a.
identifying a tissue cassette comprising a tissue sample to be
tested to a LIS-networked machine-vision system; b. transferring
machine-readable identifying information associated with said
tissue sample to said LIS; c. accessing test instructions for said
tissue sample via the LIS, the test instructions determining the
sections to be cut and the protocols to be performed on the
respective sections; d. instructing a label printer to print the
required number of labels encoding the protocols to be performed on
the corresponding tissue sections; e. printing a slide label
encoding each protocol to be performed on the corresponding tissue
section; f. attaching said slide label to a slide; g. placing at
least one tissue section on the labeled slide; and h. staining the
tissue section(s) on the slide in accordance with the protocol
identified on the corresponding slide label.
3. The method of claim 1 wherein said printer is networked to the
LIS using the HL-7 protocol.
4. The method of claim 1 wherein said patient data includes a case
number uniquely associated with a patient.
5. The method of claim 1 wherein said patient data includes the
test protocol identifiers corresponding to the tests ordered for
that specific patient.
6. The method of claim 1 wherein said data element comprises a
barcode.
7. The method of claim 1 wherein said data element comprises an
RFID.
8. The method of claim 1 wherein said data element scanner
comprises a barcode reader.
9. The method of claim 1 wherein said data element scanner
comprises a RFID reader.
10. The method of claim 5 wherein said protocol identifier
comprises an identification number that uniquely identifies the
test protocol to be performed on that slide.
11. The method of claim 1 wherein said label information comprises
machine readable information.
12. The method of claim 11 wherein said machine readable
information comprises a bar code.
13. The method of claim 11 wherein said machine readable
information comprises a RFID.
14. The method of claim 1 wherein said label information comprises
both human- and machine-readable information.
15. The method of claim 1 wherein reading cassette data comprises
scanning the tissue cassette-associated data element using a
scanner.
16. The method of claim 2 wherein said printer is networked to the
LIS using the HL-7 protocol.
17. The method of claim 2 wherein said machine-readable identifying
information includes a case number uniquely associated with the
patient.
18. The method of claim 2 wherein said test instructions comprise
the test protocol identifiers corresponding to the tests ordered
for that specific patient.
19. The method of claim 2 wherein said machine-readable identifying
information comprises a barcode.
20. The method of claim 2 wherein said machine-readable identifying
information comprises an RFID.
21. The method of claim 2 wherein said machine-readable identifying
information comprises both human- and machine-readable
information.
22. The method of claim 2 wherein inputting data comprises scanning
the machine-readable identifying information associated with said
tissue sample using a scanner.
23. The method of claim 1, further comprising: prior to said
printing, performing load leveling to distribute said tissue
samples for cutting.
24. The method of claim 23, wherein said load leveling is performed
to distribute said tissue samples to a plurality of cutting
stations in accordance with at least one of: work load of each of
said plurality of cutting stations and cutting expertise.
25. The method of claim 1, further comprising: performing load
leveling to distribute said tissue samples for cutting, wherein
said step of performing load leveling is performed after
downloading said test protocol data to said printer.
26. The method of claim 1, further comprising: performing load
leveling to distribute said tissue samples for cutting, wherein
said step of performing load leveling is performed prior to
downloading said test protocol data to said printer.
27. The method of claim 23, wherein an order in which said printing
is performed for a plurality of samples indicates the order in
which each of said plurality of samples are cut.
28. The method of claim 2, further comprising: prior to said
printing, performing load leveling to distribute tissue samples for
cutting.
29. The method of claim 2, further comprising: performing load
leveling to distribute tissue samples for cutting, wherein said
step of performing load leveling is performed after sending
instructions to the label printer to print.
30. The method of claim 2, performing load leveling to distribute
tissue samples for cutting, wherein said step of performing load
leveling is performed prior to sending instructions to the label
printer to print.
31. The method of claim 28, wherein said load leveling is performed
to distribute said tissue samples to a plurality of cutting
stations in accordance with at least one of: work load of each of
said plurality of cutting stations and cutting expertise.
32. The method of claim 28, wherein an order in which said printing
is performed for a plurality of samples indicates the order in
which each of said plurality of samples are cut.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 60/751,807, filed on Dec. 19, 2005, entitled
AUTOMATED LEAN METHODS IN ANATOMICAL PATHOLOGY, Attorney Docket No.
310/003/PPA, which is incorporated herein by reference in its
entirety.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The methods of the invention are directed generally to the
field of anatomical pathology, more specifically to the art of
tissue staining. Yet more particularly, the methods demonstrate a
novel technique for enhancing workflow through the AP lab by better
coordination of information management.
[0004] 2. Description of Related Art
[0005] Traditional manufacturing processes often encompass single
skilled operators, high work in process inventories, constant
expediting, and production schedule shuffling. These features add
limiting effects, such as inefficiency in output, manpower, high
work in progress inventories, and assembly line operations.
Originally, lean production was implemented in manufacturing or
assembly line processes to overcome the problems associated with
traditional manufacturing. Lean production was based on the Toyota
manufacturing system and typical practices can be found in "The
Machine that Changed the World," by James P. Womack, 1991, Harper
Collins Publishing Co. The basic philosophy of the lean production
system is to manufacture in the most economical way possible. This
is accomplished by focusing on meeting customer requirements, such
as producing a high-quality product while minimizing wasted
resources and time.
[0006] The hospital-based Anatomical Pathology ("AP") laboratory
has evolved around the individual patient case. That is, each
patient will require anywhere from 1 to approximately 20 tests
(slides), based on the clinician's initial diagnosis. Therefore, AP
labs have evolved a series of "batch"-based processes that reflect
this initial workflow model. To accommodate the AP labs, companies
have provided workflow solutions that emulate this batch process,
and the AP lab has evolved into a series of batch workflow modules.
Traditionally, IHC and Special Stains tissue staining was performed
manually, and up to about 1991 with the advent of the 320 System
from Ventana Medical Systems, Tucson, Ariz., there was no
alternative to the tedious manual staining process. The tissue
staining process is divided into a series of fundamental steps
comprising embedding the tissue in paraffin, sectioning the tissue
into thin (4 microns is typical) slices called "sections," mounting
the sections on a microscope slide, deparaffinizing the
paraffin-embedded tissue sections, changing the hydrophobic
environment the tissue then exists in to an aqueous environment via
a series of graded xylene/alcohol/water baths, staining the tissue
using one of five basic techniques (H&E, Papanicolau stain,
IHC, ISH or Special Stains), re-grading the tissue to a hydrophobic
environment, and finally coverslipping the tissue for archival
purposes. Most of these processes are performed on a "batch" of
samples simultaneously for economy of scale. Automated tissue
staining can be thought of as a series of automated batch processes
that mimics, for the most part, the manual processes.
[0007] For example, one of the first steps is embedding the tissue
in paraffin so that it can later be manually cut by a microtome
into a section. Companies such as Sakura (TISSUE-TEK.TM.),
ThermoShandon (EXCELSIOR.TM.), Leica (ASP300.TM.), and Vision
Biosytems (PELORIS.TM.) and others provide tissue processors that
process tissue blocks by the hundreds, but all in batch mode. There
is one new entrant that purports to continuously process tissue,
the Sakura Xpress.TM.. Also, most Hematoxylin & Eosin primary
staining systems are also batch in that they stain baskets or trays
of slides in large numbers simultaneously. See, e.g., the Leica XL
Stainer, the Sakura DRS-60, etc.
[0008] A fundamental concern in today's AP lab is sample tracking.
Hospitals are continuously challenged by the size and complexity of
testing requirements, as clinicians and primary care professionals
demand more and faster turnaround times. Opposed to this pressure
for more/better/faster is the need to unambiguously track samples
so that mix-ups and errors do not occur. The computer is ideally
situated to do this, and so hospital information systems have been
developed to track every hospital-based activity from admissions to
testing. In addition, systems vendors have also designed Laboratory
Information Systems ("LIS") that are a part of or integrate with
the Hospital Information System ("HIS") so that labs can manage
their unique requirements while remaining in contact with their
customers. A typical LIS is designed and sold by Cemer as the
PathNet.RTM. family of laboratory information solutions (Cemer
Corp., Kansas City, Kans.).
[0009] A typical workflow in today's AP lab is shown in FIG. 1. It
is a mix of manual and automated batch processes that is ripe for
additional improvement. A fundamental issue remaining to be
resolved is the lack of a complete information tracking solution
for the entire tissue staining process.
SUMMARY OF THE INVENTION
[0010] An embodiment of the method of the invention is a method of
automating information flow in a laboratory performing tissue
staining comprising positioning a networked label printer adjacent
to a cutting station, the printer configured to access patient data
directly or indirectly from the hospital LIS, the printer being
configured with a data element scanner in electronic communication
with said printer; inputting data from a tissue cassette-associated
data element at said printer, whereby inputting data comprises
reading the data from the cassette-associated data element and
uploading the cassette data to the LIS; identifying the
corresponding test protocol identifier and then downloading the
test protocol data to the printer; printing information on labels
corresponding to each test specified in the LIS for the patient;
attaching a single label to each slide; and cutting a tissue
section for each labeled slide and mounting the section on the
slide.
[0011] Another embodiment of the invention is a method of
coordinating tissue sample information in a laboratory staining
process, comprising the steps of identifying a tissue cassette
comprising a tissue sample to be tested to a LIS-networked
machine-vision system; transferring machine-readable identifying
information associated with the tissue sample to the LIS; accessing
test instructions for the tissue sample via the LIS, the test
instructions determining the sections to be cut and the protocols
to be performed on the respective sections; instructing a label
printer to print the required number of labels encoding the
protocols to be performed on the corresponding tissue sections;
printing a slide label encoding each protocol to be performed on
the corresponding tissue section; attaching the slide label to a
slide; placing at least one tissue section on the labeled slide;
and staining the tissue section(s) on the slide in accordance with
the protocol identified on the corresponding slide label.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 is a flow diagram depicting the histology value
stream map for a tissue sample traveling through its various
processes from receiving to sign-out.
[0013] FIG. 2 is a picture-diagram of an embodiment of the present
invention showing the method as practiced in one scenario.
[0014] FIG. 3 is a picture-diagram of an alternative embodiment of
the invention.
[0015] FIG. 4 is a diagram showing the function blocks of the
LIS.
[0016] FIG. 5 is a flow diagram illustrating processing steps in
one embodiment of the techniques herein.
DETAILED DESCRIPTION OF THE INVENTION
A. Introduction
[0017] Lean methodology comprises 5 basic steps: 1) observe the
process you wish to model, 2) define that process, 3) define
opportunities within the existing process, 4) develop improvement
opportunities, and 5) implement and sustain the improvements. Lean
principles as applied to the Anatomical Pathology lab suggest that
developing a map of the existing process is a recommended starting
point. In FIG. 1 is shown a Histology Process Map, which is a
visualization of one particular histology production path,
including both materials and information. At the left side of the
figure the sample is first received ("Specimens Received"), then a
Request Slip is generated for the tests to be performed, which is
entered via the hospital's Lab Information System ("LIS").
Typically the LIS is a networked software enterprise that links
requesters and providers with test request and test status and
result information. The system normally is all-inclusive: anyone in
the hospital who needs to request or process requests for testing
may have access to it. It stores test requests and test data for
patients within the hospital, and submitted from outside on an
out-patient basis too. The LIS will have a database for tracking
the test for each patient having tests performed. The LIS will
assign a case number to the patient and correlate the patient's
case no. with data such as the treating physician, other physicians
involved in the case, inpatient/outpatient status, insurance
information, requested tests, status of tests, results of tests,
etc.
[0018] The general AP lab process is described herein, but includes
many steps for each of the general processes described.
Accessioning is the first step in tracking the sample through the
use of the LIS. Sample identity, test requests, case no., etc. are
assigned and/or logged into the LIS during accessioning. Some AP
labs assign an "accession number" in addition, which is a unique
numbering system for the AP lab only. The data typically includes
the case number which is usually the unique identifier assigned by
the hospital LIS to identify the patient. The LIS database will
have further data linked to the case number which will define the
tests to be performed in the AP lab. Typically such test data
includes the type of staining tests such as a primary stain
("H&E") and/or a secondary stain ("Special Stains/IHC/ISH").
The primary stain is normally a Hematoxylin and Eosin combination
stain. Secondary stains include a "Special Stain," an
Immunohistochemical ("IHC") stain, or an in situ hybridization
("ISH") stain. Pap stains are yet another type of specialized
stain.
[0019] Still referring to FIG. 1, once cassettes have been
identified and entered into the LIS, they then enter the grossing
station. This is where the "gross" tissue is prepared for all
further analytical treatment. The appropriate tissue samples are
placed in cassettes, which are small, perforated plastic containers
having hinged doors for holding tissue samples for subsequent
chemical processing and paraffin infiltration. The cassettes must
have some form of data element written or encoded upon them in
either indelible ink, or in a machine-readable label such as a bar
code or RFID. The data element is necessary to track the sample
while in the cassette. The samples in the cassettes are then
submitted to tissue processing and embedding in paraffin. Tissue
processing typically results in the samples being immersed in
multiple baths of progressively more concentrated ethanol to
dehydrate the tissue, followed by a clearing agent such as
chloroform, xylene or Histoclear.TM., and finally hot molten
paraffin wax (infiltration). During this 4 hour process, paraffin
wax will replace the water: soft, moist tissues are turned into a
hard paraffin block, which is then placed in another cassette
containing more molten wax (embedding) and allowed to cool and
harden. The resulting tissue sample has its water replaced with
paraffin, and is hard enough for cutting into thin, essentially
transparent slices or "sections" of the tissue.
[0020] In the sectioning process, due to the fragility of the
sections, they are first manually cut and then floated onto the
surface of a water bath, where they flatten out and float. Each
section is then picked up from beneath by raising a slide below a
floating section so that the section settles onto the slide
surface. After drying and baking the sections onto the slide they
are then ready for the staining process. However, the
paraffin-embedded sections must first be deparaffinized, and then
the paraffin solvent must be exchanged (again) with successive
ethanol:water solutions until the tissue is again steeped in an
aqueous environment. Most stains are water-based but in any event
they selectively highlight tissue structures to reveal the
morphology of the tissue sample. Morphology is the key to
determining whether the sample is normal or not. Normal morphology
indicates no further testing is necessary, while suspect morphology
may prompt recuts for additional primary and/or secondary staining.
After staining, the slides are dehydrated again to allow for
archiving using glass coverplates, which are glued onto the tissue
section using a non-aqueous glue to create a permanent,
coverslipped slide. Lastly, the slides may be permanently labeled,
sorted and transported in a group arranged by patient or case no.
to the Pathologist for review and analysis. At this point, the
Pathologist will determine whether imaging, additional staining, or
signing out is the next step.
[0021] Tissue staining may also be performed on intact cells, and
when done so is termed "Cytology." For example, cervical samples
are taken from the cervical area by a wash process whereby the
surface of the cervix is brushed and washed, and the washed cells
are collected in a specially formulated preservative solution. The
cells are then filtered onto a charged glass slide where they
adhere for further staining operations. For purposes of the present
invention, whether the methods of the invention are performed on
tissue samples or cells is irrelevant. One system that automates
the filtering and applying steps is sold by TriPath, Inc.
(Burlington, N.C.).
[0022] It should be understood that this basic flow has existed for
the recent past, and all processes until the last 10 years or so
were performed manually. The typical Histology lab may employ
several individuals to perform all of these steps, who may
collectively process up to 500 slides a day, and so the tissue may
shuttle through a chain of custody during its stay in the AP lab.
With the advent of automation and lean systems design, the paradigm
for the AP lab is evolving quickly. Clearly, with all of the
manipulations of the tissue that occur during this process,
acccurate tracking of the samples has become of extreme
importance.
B. Definitions
[0023] The following terms are intended to have the indicated
meanings denoted below as used in the specification and claims.
[0024] The term "networked label printer" means a label printer
that is connected to a laboratory information system or network.
"Networked" means in general that an electronic device is connected
to an electronic network capable of communicating both data and
command information. In the present context the networked label
printer receives data that is to be printed on the slide labels.
The label printer may also send signals to the network regarding
its status for readiness for accepting instructions to print,
status of the print jobs in its print queue, printed labels
awaiting affixation to slides, etc.
[0025] The terms "label printer" and "labels" includes standard
slide label printing devices such as the EBAR.TM. printer (Ventana,
Tucson, Ariz.) and the labels that go with it. The EBAR is not
network-ready, but a network-ready label printer is sourced through
General Data (Cleveland, Ohio), called the SATO CT410DT thermal
printer, and is used in conjunction with the StainerShield.TM.
slide labels and UltraLabel.TM. Gold v. 7 software. Slide labels
need to fit the frosted end of the slide and also need to withstand
the chemical processing steps they may be subjected to, including
contact with solvents such as xylene and alcohol. In addition, the
term "printer" may also apply to a device that prints directly to
the slide such as a slide printer or slide etcher. These devices
may etch via laser or print the bar code directly to the slide in
indelible ink, thus obviating the need for a separate label. An
example of such a device is the Leica IPS, (Leica Microsystems AG,
Wetzlar, Germany) which also prints on tissue cassettes.
[0026] The term "patient data" includes data stored or accessible
by the LIS that is uniquely associated with a patient. Typically
this data includes the patient's name, case number, the tests to be
performed on the patient's tissue sample, the protocols and their
respective identification numbers that correlate to the test, the
date the tissue was entered into the LIS, the doctors associated
with the patient, etc.
[0027] The term "cutting station" means the area dedicated to
sectioning tissue in a tissue cassette using a microtome or similar
device. The cutting station is the workplace area where the tissue
cassette is placed into a microtome for subsequent cutting
operations, usually performed manually by a histology technician.
The sections are approximately 3-6 microns thick, and are "floated"
onto a water bath where they then are picked up on a slide. The
cutting station includes a microtome with its water bath, and may
also include a machine-vision capable scanner capable of reading
information from e.g. a barcode.
[0028] The term "LIS" is shorthand for "Laboratory Information
System." A LIS is commonly understood to be a software-driven
electronic network for connecting lab instruments and computers so
that at a minimum their statuses may be monitored through one or
more centrally-located computers. Elements of the software allow
common control and communication amongst a group of instruments
that share a common networking protocol. One such protocol is the
HL-7 protocol. HL-7 is an ANSI standard for healthcare specific
data exchange between computer applications. HL-7 stands for
"Health Level 7", which refers to the top layer (Level 7) of the
Open Systems Interconnection (OSI) layer protocol for the health
environment. Most new lab instruments have now adopted this
protocol. A typical LIS is designed and sold by Cemer as the
PathNet.RTM. family of laboratory information solutions (Cemer
Corp., Kansas City, Kans.). Other LIS's are the Impac (Tamtron),
and MediTech's LIS-Magic.
[0029] The term "data element" means a device for capturing/storing
data in a machine or human-readable format. Examples include a
slide label containing both alphanumeric information such as the
case no. and a barcode for a barcode scanner to read. A typical
data element is a barcode label, although others may include a
Radio Frequency Identification Device ("RFID"), a magnetic stripe
with magnetically-encoded information contained with it such as
found on credit cards, or optically-encoded text information that
may be read by a digital camera and translated via Optical
Character Recognition (OCR) software. Barcodes may also include
fully optically-readable devices such as optically-encoded elements
1-D and 2-D barcodes, data matrixes, and data glyphs. Alphanumeric
characters on a slide label may also be data elements. Alphanumeric
characters may be scanned by a digital camera, the text decoded via
OCR software, and the resulting information transferred or stored
for later use.
[0030] The term "data element scanner" includes any machine vision
system configured to read the encoded information from the data
element as defined above. Typical scanners include RFID readers,
barcode scanners, magnetic strip readers, digital cameras, etc.
[0031] The term "in electronic communication" means that the system
being referred to is electrically connected, either via hard
connection (e.g. copper wiring, fiber optic cables, etc.) or
wirelessly through a wireless link, to another system for which
communication is desired, and both can either send and/or receive
signals from the other.
[0032] The term "tissue cassette" is a common descriptor for a
tissue sample case which functions to position and contain the
tissue sample for embedding in paraffin. After embedding, it
continues to be used to position the sample for subsequent cutting
in the microtome. A tissue cassette needs to have basic identifying
information associated with it because the samples are usually
loaded in batches of several hundred to the embedder. Thus, each
cassette must have at least one unique identifier such as a
cassette number, case number, accession no., or a combination of
the them in order for the lab to track the tissue sample within.
Typically a cassette has the accession or case no. information
encoded in a barcode, or alphanumeric text is written in indelible
ink. For purposes of the present inventive methods, either come
within the scope of the invention.
[0033] The term "cassette data" refers to the unique identifying
number for the cassette, if any. Cassette data would be used by the
histology lab to track cassettes. The case number may also be
included in the cassette data.
[0034] The term "identifying" as used in the phrase "identifying
the corresponding patient test protocol data" means that the LIS or
an intermediary software application associates the cassette data
with the tests to be run on that specific sample, and then the LIS
or intermediary will send instructions to the printer to print the
required labels, based on the number and types of tests specified
in the LIS or intermediary.
[0035] The term "machine-vision system" means any machine-based
system having the capacity to translate and/or communicate
information encoded in the electromagnetic spectrum into
information cognizable by a machine. Common machine-vision systems
available today include camera-based systems, the cameras designed
to detect information from the infrared, ultraviolet, x-ray, and
visible portions, to name a few. Other machine-vision systems may
read and send information in the radio portion of the
electromagnetic spectrum such as RFIDs, mentioned previously. Any
machine-vision system now know or hereafter developed comes within
the scope of the present invention.
[0036] The term "machine vision identifying information associated
with a tissue sample" means the encoded information attached to or
associated with the tissue sample, as for example, a barcode on a
slide having a tissue specimen thereon, or an RFID attached to or
embedded in a tissue cassette holding a tissue sample. However, the
identifying information may also be indirectly associated with the
cassette.
[0037] The term "test instructions" are those tests that have been
ordered by the clinician for the respective patient. These
instructions normally indicate the type and number of tests to be
run. Test instructions may specify a primary stain such as an
H&E (Hematoxylin and Eosin) stain, any number of secondary
stains such as an Immunohistochemical stain utilizing antibodies
specific for disease markers, a in situ hybridization (DNA probe)
stain, or a Special Stain (a purely chemical stain). In addition,
control tests may also be specified by the test instructions.
[0038] The term "test protocol identifier" is the unique number
used to associate a protocol with its individual steps or the
recipe for the protocol. For a staining protocol, each protocol
includes a number of staining steps needed to perform the entire
staining process on that individual tissue section. Other protocols
may be specific for deparaffinization, antigen retrieval, baking,
and other processes automated by a staining system. The test
protocol identifier is typically encoded in a machine-readable
identifier such as barcode label so that when an automated staining
system reads the slide label, it then uses the protocol identifier
to look up in a protocol table the requisite steps for performing
the staining operation. A full run will require hundreds and
perhaps thousands of individual steps to complete the testing for
the numerous samples being processed. For example, the
BenchMark.TM. XT system (Ventana, Tucson, Ariz.) has a 30-slide
capacity, which means 30 tests may be run simultaneously, each test
having from 50 to 100 individual steps.
[0039] The term "case no." is the identifier given by the hospital
to the individual patient sample. It is the key to maintaining the
confidentiality of the patient, yet allows the hospital staff to
track and complete their tasks without compromising the patient's
identity.
[0040] "VIP/VLM" refers to the Ventana Interface Point/Ventana Lab
Manager software embedded in the NexES v. 10.1 software (Ventana,
Tucson, Ariz.). The VIP serves as the interface between the LIS and
the VLM. The VLM is the managing software that facilitates
replication of data between Ventana automated staining systems,
thereby allowing them to share reagents and status data so that
staining operations may be optimized in a lab running multiple
Ventana staining instruments. A fuller discussion is contained in
U.S. patent application Ser. No. 11/032,324 filed Jan. 10, 2005,
incorporated herein by reference.
C. Description of Embodiments of the Invention
[0041] An embodiment of the method of the invention is a method of
automating information flow in a laboratory performing tissue
staining comprising the following steps. First, positioning a
networked label printer adjacent to a cutting station, the printer
configured to access patient data directly or indirectly from the
hospital LIS, the printer being configured with a data element
scanner in electronic communication with said printer. It is
efficient from a lean systems perspective to position the label
printer next to the cutting station because the LIS will send print
commands for slide labels that correspond to cassettes located at
the same cutting station. Thus, it is more efficient for the cutter
to stay at the cutting station and not to have to get up and locate
the labels at a label printer located some distance away.
[0042] The next step involves inputting data from a tissue
cassette-associated data element at the label printer, whereby
inputting data comprises reading the data from the
cassette-associated data element and uploading the cassette data to
the LIS. The data element may be, e.g., a barcode label, and the
cassette data encoded within the barcode may be a unique
identification code for the cassette. That code would already be
assigned during accessioning, and the LIS correlates the tests to
be run with that cassette code. In the case of a barcode, the step
of reading the data may be accomplished simply by scanning the
cassette bar code with a barcode scanner. The barcode scanner may
be standalone, or alternatively may be built into the microtome or
label printer. It is not important to which device it is attached,
if any. The barcode scanner may be a wireless hand-held scanner. If
the data element is not a barcode but is an RFID for example, then
the AP lab may have a RFID lab network tracking the samples at all
times. Inputting data from an RFID-equipped cassette may be as
simple as "wanding" the cassette within the reading range of the
RFID reader. The RFID reader would detect the presence of the
cassette and register it with the LIS as ready for slide label
printing. Alternatively, the cassette data may be manually entered
into the labeling software GUI if for some reason the cassette data
cannot be read by the barcode scanner. Reading and uploading the
data would then be accomplished manually, and comes within the
scope of the inventive methods of the invention.
[0043] The next step is identifying the corresponding patient test
protocol data and then downloading the test protocol data to the
printer to be printed on labels. As mentioned above, the LIS will
already have entered into it a list of tests to be run on the
specific sample that corresponds to the cassette data. The LIS or
an intermediary software application such as the Ventana Lab
Manager ("VLM," Ventana, Tucson, Ariz.) may correlate the cassette
data with the sample and tests that have been ordered by looking up
the case no. data in the LIS/VLM. The case number will dictate the
number of sections to be cut, which in turn determines the number
of labels required. Specific protocol identifiers are downloaded to
the label printer, where each label will have them printed on it.
The labels are used by the automated stainer in the next phase of
the staining process. The protocol identifiers are read by the
automated staining system, correlated with the correct series of
staining steps (a staining "protocol") and the run is performed
accordingly. Each label may also contain human-readable characters
describing various important information such as case no., stain
type, etc.
[0044] The next step comprises printing information on labels
corresponding to each test specified in the LIS for the patient and
attaching a single label to each slide. As previously described,
after the LIS identifies the test protocol data from reading the
cassette, the protocol identifiers are sent to the label printer
for printing. Slide labels are printed and the histotechnician
places them on the frosted end of the slide. There are only two
possibilities at this point for slide labeling: the slide is
labeled before the sample is placed on it, or the slide is labeled
afterwards. The methods of the present invention contemplate either
situation. The labeling step completes the transfer of information
from the cassette to the slide, and is an important step ensuring
that the sections have the same identifying information as the
cassette.
[0045] If the test ordered is an IHC, Special Stains or an ISH
test, then a positive control slide will be needed. The positive
control slide has a positive sample on it, and information
identifying it as such. After the cassette has been identified to
the LIS, the LIS patient information will already specify a
positive control, and a slide label will be printed that contains
information identifying both the sample and the positive control.
This new label will be overlaid on the original positive control
slide.
[0046] The final steps are cutting a tissue section for each
labeled slide and mounting the section on the slide. Normally, the
technician will print all the labels, then label the slides, and
park the labeled slides next to the water bath. The technician will
then cut a series of sections, one per slide, and leave them
floating for pickup. Then the technician will pick up one section
per slide (H&E) or additional sections on additional slides if
a secondary stain (IHC/SS/ISH), and place the slide on a rack for
the baking step. If the technician is labeling first and applying
tissue second, then there should be a minimum possibility of error
at this stage. However, if the technician is applying tissue first
and labeling second, then he must be sure the block in the
microtome corresponds to the slide labels. Otherwise, there will be
unlabeled slides with tissue sections on them in the cutting area,
raising question about what their identity is.
[0047] A slightly different process applies when the stain is an
IHC stain. As previously mentioned, a positive control slide must
be used. A positive control slide already has a tissue section
adhered to it that will be positive, that is, it will react with
the stain to highlight the presence of the biochemical marker being
tested for. For instance, if a test for ER (Estrogen Receptor) has
been ordered, then the sample will be adhered to an ER positive
control slide, which comes with an ER-positive "control" tissue on
it. The result is that there will be two sections on the slide, one
a known positive, and the other the test sample. If all automated
staining functions are working correctly, then in the event of a
negative sample at least the positive control will stain. If both
tissues stain positive, then the sample is truly positive. A
positive control slide contains information providing traceability
and/or some indication of what the test is. For example, in the
above ER situation, the slide will have a label or penciled
information which contains "ER positive" and/or a traceability
number somewhere on it. In order to ensure the cassette/sample data
gets matched to the correct slide, the positive control slide label
will have to be over labeled with a new label containing the
previous information (e.g. "ER positive") and the new sample data.
For primary staining a "batch control" may be used, which is a
single control for an entire batch of slides, to ensure the
staining system is working properly.
[0048] Another embodiment of the invention is directed to a method
of coordinating tissue sample information in a laboratory staining
process comprising the steps of identifying a tissue cassette
comprising a tissue sample to be tested to a LIS-networked
machine-vision system. The machine-vision system is commonly
described as a machine, instrument or computer enabled with a
remote information reading capability. Common examples of such
machine-vision systems are robotic cameras used on assembly lines
to identify parts and tools, barcode scanners such as supermarket
checkout scanners, RFID-enabled systems which have the additional
capability of writing to the RFID on the product being tracked,
etc. These are examples of optical and radio-frequency devices.
[0049] The next step is transferring machine-readable identifying
information associated with the tissue sample to the LIS. The
identifying information associated with the tissue sample is
commonly the cassette identifier or case number. In either event,
it may be printed or etched onto the cassette surface by a printer
or laser-based etcher so as to create an indelible pattern readable
by a human and/or machine. For example, the act of transferring the
information is met by the scanning process, for a barcode. The
barcode scanner will read the barcode information and then transmit
it to the LIS or middleware solution such as the VLM, mentioned
previously.
[0050] The next step is accessing test instructions for the tissue
sample via the LIS, the test instructions determining the sections
to be cut and the protocols to be performed on the respective
sections. As mentioned above, the LIS will already have entered
into it a list of tests to be run on the specific sample that
corresponds to the cassette data. The LIS or an intermediary
software application such as the Ventana Lab Manager ("VLM,"
Ventana, Tucson, Ariz.) correlates the cassette data with the
sample and tests that have been ordered by looking up the case no.
data in the LIS/VLM. For example, if the test instructions in the
LIS say "ER" for this case no., then the LIS will formulate the
command to print two labels, the first having the ER protocol
identifier and the case no., and the second label having the ER
positive control tissue protocol identifier and case no. on it.
Although the control test may not be specified in the LIS, the LIS
should be programmed so that by default if certain tests are
ordered, then the requisite control will also be added to the list
of tests to be run.
[0051] The LIS or VIP/VLM will instruct a label printer to print
the required number of labels encoding the protocols to be
performed on the corresponding tissue sections. It should be known
to one of ordinary skill that a slide printer may also be used for
this function. A slide printer directly encodes the information
onto the surface of the glass slide, eliminating the need for a
separate labeling step. An example of a slide printer is the Leica
IPC, (Leica Microsystems AG, Wetzlar, Germany).
[0052] The last steps of the process include printing a slide label
encoding each protocol to be performed on the corresponding tissue
section; attaching the slide label to a slide; placing at least one
tissue section on the labeled slide; and staining the tissue
section(s) on the slide in accordance with the protocol identified
on the corresponding slide label. More than one section may be
placed on a slide, including in some embodiments one or more
control tissue sections.
[0053] The following examples are illustrations of the embodiments
of the inventions discussed herein, and should not be applied so as
to limit the appended claims in any manner.
D. Examples
[0054] FIG. 2 is a picture-diagram of one embodiment of the
invention. It depicts the basic flow of a tissue cassette coming
from Embedding to the Cutting Station. Cassettes 10 having paraffin
blocks containing patient samples embedded in paraffin are located
in a queue waiting to be scanned in at the scanner 20. Scanner 20
may be a barcode reader, an RFID antenna, a magnetic stripe reader,
an imaging system using a digital camera or any similar
machine-readable technology, depending of course on the technology
adopted by the AP lab. Assuming for purposes of illustration only
the scanner is a barcode scanner, at the scanner 20 the technician
will scan the cassette and the scanner will send the data to the
laboratory network or data bus 70 for further processing by the LIS
80 via the VIP 75. The lab may utilize an intermediary software
solution such as the Ventana Interface Point/Ventana Lab Manager
("VIP/VLM") software/hardware 75/77 to provide an interface between
a network of Ventana instruments and the AP lab's LIS. The VIP/VLM
is described in more detail in co-pending U.S. patent application
Ser. No. 11/032,324 (Showalter, et al.) filed Jan. 10, 2005,
incorporated herein by reference in its entirety. LIS 80 is
described in more detail infra in FIG. 3. Microtome 30 has mounted
in its block a cassette 10, which is to be cut by a technician.
Sections (not shown) are floated onto water batch 40 and await
pick-up onto slides 50. Slides 50 may be labeled prior to pickup,
or may be labeled immediately after pickup. If the test is an IHC
test, then the slide may be a positive control slide, in which case
it will need to be re-labeled. In either event, label printer 60
prints slide labels having barcoded information readable by the
stainer. The slide labels will at least contain the case no. It
will generally contain the stain protocol identifier as well. After
the tissue has been picked up and the slide labeled, the slide will
be placed on a tray 90 that will then be placed into an oven for a
short baking cycle to adhere the tissue to the slide for the
subsequent tissue staining processes.
[0055] FIG. 3 illustrates an alternative embodiment. It differs
from the embodiment of FIG. 2 in that the label printer 60 may be a
shared lab resource, and thus may be located distal to the cutting
station. Label printer 60 is still networked to the VIP/VLM and in
electronic communication with the LIS, but a separate printer is
not located at each cutting station. Each cutting technician will
therefore have to go to the labels, or the labels will have to be
brought to them.
[0056] FIG. 4 is a flow diagram showing the steps of a method of
the invention. In step 302, the labeling software graphical user
interface ("GUI") is open and a data input screen allows the
histotechnician to input cassette data, or monitor the automated
scanning of the cassette data into the VIP/VLM. In step 304, the
histotechnician responsible for cutting sections ("Cutter") inputs
the cassette data either by scanning the cassette, or by manually
inputting the cassette identifying information. Preferably it is
automated so as to reduce data entry errors. In step 306, the
cassette identifying information is sent or made available to the
VIP/VLM. Once the VIP/VLM records that it has a new cassette at the
cutting station, it queries the LIS in step 308 for the
corresponding patient data, including the tests to be performed. In
step 310, the VIP/VLM will format the proper test instructions for
printing on a slide label. Alternatively, if a slide printer is
being used instead of a slide labeler, the VIP/VLM will formulate
the instructions for the slide printing process. In step 312, the
labeling or printing instructions are sent to the label printer or
slide printer, as the case may be. At this point the diagram
diverges to illustrate the two potential paths. If slides are to be
printed, processing continues with step 316 where the slide printer
prints the slides. If the system includes a labeler steps 314 and
318 are performed. The extra step of labeling is performed by the
Cutter in step 318. Next, in step 320, the Cutter cuts the sections
and floats them onto the water bath. Finally, in step 322, the
Cutter mounts the sections on the labeled or printed slide and they
are then ready to go to the drying (or baking) step 324.
[0057] FIG. 5 is a flow diagram illustrating processing steps in
yet another embodiment of the techniques utilizing the principles
of JIT (Just in Time) manufacturing for Histology. In step 402, the
accession and test information is entered into the LIS. In step
404, test information is sent from the LIS to the VIP/VLM.
Processing associated with step 402 that may be performed in an
embodiment is described elsewhere herein, for example, in
connection with steps from FIG. 3. In step 406, the Histology
Manager may intervene to set work priorities for the cutters. The
foregoing may be termed "load leveling" and involves distributing
the appropriate activities to the cutters so as to ensure no work
bottlenecks occur. The introduction of "level loading" after the
information is sent from the LIS allows management to balance the
distribution of blocks to individual cutters thereby better
managing lab productivity. The distribution of work to the cutters
as performed in step 406 may be performed by the Histology Manager
considering any one or more different factors. For example, the
work distribution may be based on the availability and current load
of each cutter, any cutting expertise or specialty of each cutter
for the various types of tissue samples, and the like. After the
load leveling step 406, the printer prints instructions (typically
case number or name) in step 408 to signal to each cutter which
is/are the next case(s) or block(s) to cut. In other words, the
action of printing drives or controls the cutting process in that
printing serves as a signal to the cutter of when to cut a next
section and from which sample. The foregoing refers to application
of the Kanban System and techniques. "Kanban" is a Japanese term
that means "signal." In JIT manufacturing, the term Kanban may be
used to denote a stocking system that uses signals to make
production systems respond to real needs and not predictions and
forecasts. Introducing the foregoing principles and techniques
reduces the overproduction of blocks/slides and eliminate
mistakes.
[0058] It should be noted that the load leveling step 406 may be
performed at various points prior to the printing. For example, as
described herein with reference to FIG. 3, the VIP/VLM creates the
printing instructions in step 310 and then sends the printing
instructions to the label or printer in step 312. In one
embodiment, the load leveling may be performed prior to the VIP/VLM
sending the print instructions to the labeler or printer, such as
after step 310. In another embodiment, the load leveling may be
alternatively performed after the print instructions are sent to
the printer in step 312 but prior to printing in either of steps
314 or 316. In yet another embodiment, the load leveling may be
performed after the VIP/VLM receives the test information from the
LIS (e.g., step 308) but prior to creating the printing
instructions in step 310.
[0059] The step of load leveling as described herein may be
performed by the histology manager or other appropriate individual
using any one or more manual and/or automated techniques. For
example, in one embodiment, the distribution may be performed by
the histology manager visually inspecting and/or verbally inquiring
of individual cutters regarding their capacity. In another
embodiment, software may be used to track and monitor the current
allocations, workload, and/or performance aspects of the various
cutting stations and used in connection with determining the
distribution of additional samples. The foregoing are just examples
of different manual and/or automated techniques that may be
utilized in an embodiment.
[0060] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as
exemplifications of preferred embodiments. Those skilled in the art
will envision other modifications that come within the scope and
spirit of the claims appended hereto. All patents and references
cited herein are explicitly incorporated by reference in their
entirety.
* * * * *