Laboratory reporting system and labeling system therefor

A labeling system for pathology reports which is useful to adhere the prepared report directly to the patient's chart without the need for transcription. The system of the invention incorporates means for ease of recognition of problem diagnosis, graphics of the biopsy anatomical site which includes colorization that allows easy identification of diagnosis and the area to be treated. The system of the invention also provides for an indication of recommended follow-up treatment, non-treatment or close follow-up as may be appropriate. This system includes an overlay system and a system to follow suspicious lesions with or without their physical relationship to previously biopsied sites.

BACKGROUND OF THE INVENTION 
The present invention relates generally to a system for reporting the 
results of pathology laboratory tests. More particularly, the present 
invention relates to a pathology report system including labels containing 
diagrams, anatomical site, photomicrographs, photographs and summarized 
reports that may be adhered to the patient's chart. 
Presently in the United States, virtually all pathology service companies 
provide a general pathology or dermatopathology report, along with their 
pathology laboratory services, that normally includes the name, address, 
telephone and fax number of the pathology service company. The pathology 
report also includes other information such as the patient's name, date of 
birth, sex, race, file number, physician's (client) number, location of 
biopsy, pathology number, and the dates that the biopsy was obtained, 
received and reported. In addition, this report includes clinical data 
provided by the provider concerning the impression, specimen site, gross 
description, the microscopic description and the diagnosis, as well as the 
provider's signature. This information is contained in essentially all 
pathology reports, whether specialized for dermatopathology, general 
pathology or other fields of pathology. 
It is a standard practice of physicians to enter the information on the 
pathology reports directly into the patient's chart, either by themselves 
or, more often, by having their staff copy the diagnoses and notes 
(comments) by hand from the pathology report into the chart, initialing 
the entries and writing the date received. Several errors can occur during 
this process. For example, the diagnosis may be incorrectly transcribed 
into the chart, such as by miswriting squamous epithelium as squamous 
cancer or other serious cancers. Or, the information may be incompletely 
transcribed into the chart, such as by omitting from the report a comment 
(note) that states that the margins of the body area are clear and 
completely excised. In addition, the biopsy information may be copied into 
the wrong chart. Each of these errors can easily lead to disastrous 
results, such as unnecessary surgery and perhaps even malpractice suits. 
Unfortunately, there exist few double checks in the commonly utilized 
procedures. 
Another common practice that causes errors is when a doctor merely notes on 
the file "pathology report received" and then places the pathology report 
in the chart. The problem with this approach is that the physician may 
later be unable to figure out the results of all the previous biopsies 
performed, especially for patients having thick charts or multiple 
biopsies. The only biopsy whose results are easily determined in such a 
case is the biopsy reviewed on the most recent biopsy report. This has 
often led to confusion in diagnoses and in treatment of lesions, 
especially when a chart is filled with multiple biopsies and reports that 
deal several different skin cancers and pre-cancers, as commonly occurs in 
the field of dermatology. Moreover, the time expended reviewing pathology 
reports for all previous visits is extremely wasteful. As a result, some 
doctors forgo reviewing the reports and instead rely on their memories, 
especially since as managed care has forced some physicians to shorten the 
time of the office visits. Until now, there has been no way for a 
diagnosis and other pertinent information to be entered into the patient's 
specific clinical chart and biopsy books as well as into any summary 
reports in order to facilitate rapid review of the chart without writing 
these out by hand and risking the errors described above. 
Another common practice is for many doctors to maintain biopsy books in 
which they write the name and other pertinent information regarding the 
patient and in which some doctors note whether or not the patient needs to 
be treated. The "treatment performed" section serves as a check on whether 
or not the lesion was treated appropriately. However, several errors can 
result in this instance, as well. First, many doctors do not have biopsy 
books and, even if they do, do not note whether the biopsy requires 
treatment. In addition, if a biopsy is not written or is incorrectly 
written into the biopsy book, there would be no check on the system. Also, 
if a medical assistant or nurse mistakenly checks "no treatment needed" in 
the chart, due either to difficulty in reading the doctor's handwriting or 
a lack of understanding of the diagnosis, there is no cross check in the 
system since the same nurse generally handles all aspects of the pathology 
report. There also exists the possibility of someone writing the biopsy 
report in the wrong place or of someone with poor handwriting preparing 
notes, thereby allowing other staff to skip over it, etc. In addition 
staff members may forget to enter notations into the book. Because there 
is no appropriate check on the system, all these potential failures may 
lead to additional problems with obtaining appropriate treatment for the 
specific pathological diagnosis, with almost disastrous results. Biopsy 
books are, therefore, another area of the clinical record in which a new 
system would be helpful to increase accuracy and tracking, to save time 
and money, and to decrease errors and potential lawsuits. 
Historically, there has been no easy way to follow up on biopsies entered 
in the patient chart, even though follow up can be particularly important 
with a patient who has had multiple biopsies performed on different dates, 
often in similar areas. Until now, a physician noted on the pathology 
report only whether or not the patient needed treatment. There is no 
system that illustrates the specific area treated and that also produces a 
charting system that can be entered directly into the patient's chart. 
Presently, the required clinical follow-up falls primarily on the 
shoulders of the physician with minimal backup from the responsible 
support staff, or, alternatively, primarily on the support staff, 
especially with minimal input from the physician. This situation has often 
led to difficulty in treatment or to improper treatment. There has not 
been a good follow-up system developed that would blend the two so that 
the clinician is specifically responsible and actively monitors this 
function. In particular, a follow-up should be organized, once the 
physician has had input during the set-up stage, through the use of 
specialized software in a simple way such that the physician's staff will 
know automatically from the color-coded label and pathology report which 
diagnoses require what type of follow-up. This will allow the report to be 
followed in the chart and allow patients to be called automatically with 
the appropriate message, so that other follow-up steps can be taken if 
required. This procedure eliminates duplicate work and improves patient 
care, delivery and thus saves both time and money, while delivering a 
better quality of care. A detailed follow-up system to allow the support 
staff to give the patient the appropriate and more detailed information 
and reassurance required has not been available in a simple automatic 
manner. 
Pathology reports have historically lacked accurate diagrams detailing the 
area of the body that has been biopsied. In addition, standard pathology 
requisition forms and reports do not specify the exact or even the general 
area to be treated, often leading to improper treatment or inappropriate 
tracking of the disease. Without a diagram, an area that a clinician 
refers to on the pathology requisition form as, for example, the right 
shoulder may actually be a part of the back, clavicle chest or upper arm. 
In addition, the patient may have several lesions in the same area, 
further compounding the problem. It is desirable to provide a pathology 
requisition form that identifies precisely the location of the biopsy to 
be performed. 
There is no system that transfers the exact location or quadrant where the 
biopsy is done, known as the anatomic site of biopsy, from the requisition 
slip onto a reporting system so that it can be entered in the chart, the 
biopsy book, the patient's summary report and the pathology report. 
Therefore, it is also desirable to provide a pathology report and labeling 
system that mimics the requisition form clearly identifying the location 
of the biopsy sample on the drawing. 
Moreover, there is currently no system available that produces any of these 
entries via labeling system. In addition, even if an existing pathology 
reporting system were to have a label diagram, there is presently none 
that could summarize multiple biopsies, namely a history of the patient's 
biopsy's over time, into one picture of a specific anatomic site. A 
feature that could summarize into one location or drawing results of all 
previous biopsies is crucial for the physician, who must know all previous 
sites of cancer, for example, when examining the patient during a checkup 
so as to enable him to study those areas more carefully and more rapidly. 
Typically, almost all presently available pathology reports are printed in 
black and white ink. This does not allow for easy recognition of problem 
areas and does not allow one to highlight specific problems using 
color-coding, which is more rapidly detected by staff to highlight 
potential problems. Also, currently available pathology reports are 
uniform, irrespective of the clinician's personal desires or requirements. 
A pathology reporting system and pathology labeling system that is unique 
for each clinician's individual needs, based upon their particular 
preferences and treatment patterns, has not been developed and thus is not 
available in the art. A labeling system reflecting these improvements 
would, therefore, be helpful for the clinician and for their patients. 
The applicants are aware of the following prior art references that are 
generally related to the present invention: 
U.S. Pat. No. 5,636,873 (Sonsteby) discloses a patient documentation system 
using removable adhesive backed labels in a notepad form, each pad 
relating to a specific anatomical area and/or specific illness for 
adhesion into a patient's chart. The labels can have the form of checklist 
or steps for proper medical care and documentation or the form of 
anatomical diagrams onto which annotation can be made regarding the 
medical care rendered. 
U.S. Pat. No. 4,865,549 (Sonsteby) discloses a medical documentation system 
using modularized color coded information packets relating to specific 
body systems, including peel-off labels, providing a series of diagnostic 
steps, for the temporary adhesion to the patient chart. 
U.S. Pat. No. 5,048,870 (Mangini at al) discloses multi-part flag labels 
with peel-off copies for use in pharmaceutical record keeping, inventory, 
billing, etc. Information is completed on one copy of a label and 
automatically transferred to other labels using carbon paper or the like 
such that more than one peel-off label bearing pre-printed and just 
entered data can be used. 
U.S. Pat. No. 4,295,664 (Cutting) discloses a medication record keeping 
package for charting medications prescribed and administered to a patent. 
Information recorded on a cover sheet is duplicated on underlying, 
pressure sensitive, tear-off sheets that can be removed and affixed at a 
remote location. 
U.S. Pat. No. 3,625,547 (Burke) discloses a multi part prescription form 
with separable labels for medication, prescription renewal and record 
keeping. The labels are pressure sensitive and superimposed so that entry 
of information on the top label also enters the information on a label 
underneath for adherence to another location. 
U.S. Pat. No. 4,799,712 (Biava et al) discloses a physician's prescription 
form having pressure sensitive, peel-off labels for medication bottles and 
medical charts. 
U.S. Pat. No. 5,484,170 (Hatfield, Jr.) discloses a unitary shipping label 
in the form of an adhesive label strip with multiple removable panels for 
use as shipping labels, product information labels, and packing slips. 
U.S. Pat. No. 5,637,369 (Steward) discloses a business form including a 
card produced by adhering conventional label stock to the back of the 
form, cutting entirely through the business form and partially through the 
label stock to produce a removable label and a new card. 
In view of the available prior art pathology reporting systems and the 
prior art medical documentation systems, it is clear that there is a need 
for a new system for easier charting, summarizing pathology reports, 
demonstrating diagrams and photographs, and photomicrographs allowing for 
a customized computer-generated report and customized clinical disease 
follow-up that is color-coded so as to allow for ease of treatment. 
SUMMARY OF THE INVENTION 
The present invention is directed to providing a clinician or hospital with 
pathology laboratory reports including a labeling system for pathology 
reports, which is useful in adhering sections of the prepared report 
directly to the patient's chart without the need for transcription. The 
reporting system of the invention incorporates means for ease of 
recognition of problem diagnoses and graphics of the biopsy anatomical 
site, which includes color coded categories that allow easy identification 
of diagnosis and the areas to be treated. The labeling system includes a 
clinical photograph and/or photomicrograph, digital histology photograph, 
a photograph of the patient's biopsy, and a superimposed overlay of the 
patient's previous biopsies, i.e., namely a diagram of biopsies at the 
same site over time. 
The advantages of this labeling system include (a) rapid easy charting, (b) 
avoidance of errors in transcription or labeling the wrong chart,(c) 
recognition of problem diagnoses, (d) quicker facilitation of clinical 
follow-up, (e) highlighting and describing clinical follow-up so as to 
avoid failure to treat, (f) graphics of the biopsy anatomical site 
including colorization that allows easy identification of a diagnosis 
category and area to be treated, (g) identification of recommended 
follow-up areas, (h) easy labeling of specimen bottles and fungal 
cultures, (i) customization of the labeling system in order to allow 
variations specified by the clinician, by using the software program 
accompanying the system, i) better clinical follow-up to patient, staff, 
and/or referring doctor via personalized facsimile of pathology report and 
personalized educational letters and fact sheets, and (k) interactive 
reports and personalized reports that allow for client comment and 
personalized reports that can be changed via internet access. 
It is, therefore, an object of the present invention to provide an improved 
system for reporting laboratory pathology results. 
It is another object of the present invention to provide a clinician or 
hospital with a pathology report labeling system that includes a summary 
report to adhere to the patients chart. 
It is a further object of the present invention to provide a clinician or 
hospital with a pathology report system that includes a graphic depiction 
of the biopsy area of the body with an accurate indication of the biopsy 
location, which depiction is color coded and shape coded to allow for 
rapid diagnosis and decrease in risk of error. 
It is yet another object of the present invention to provide a clinician or 
hospital with a pathology report system that includes a color-coded 
indication of diagnosis. 
It is still another object of the present invention to provide a clinician 
or hospital with a pathology report system that includes a recommended 
course of follow-up treatment. 
It is still a further object of the present invention to provide a 
clinician or hospital with a pathology report that includes a series of 
removable labels, the format of which may be customized as to content, 
size and number to include whatever information the user desires, which 
labels may subsequently be applied to a patient's chart, a physician's 
biopsy book, a follow-up log or to other locations as may be deemed 
appropriate. 
It is another object of the present invention to provide a pathology report 
system that would allow the clinician to choose and design certain 
parameters of his pathology report such as size of report, type style, 
comments etc. 
It is a further object of the present invention to provide a pathology 
report labeling system that would allow for clinical photographs and/or 
photomicrographs to be placed on the report and on the labels for the 
pathology chart. 
It is yet another object of the present invention to provide a clinician or 
hospital with a pathology report which has a superimposed overlay of the 
anatomic site diagnosis all in one diagram by site, which can be separated 
by diagnostic category, follow-up type diagnosis and other criteria. 
It is still another object of the present invention to provide (1) an 
interactive program for preparing a personalized patient letter designed 
by the clinician with or without a clinical diagram, photograph, and/or 
photomicrograph, including all relevant biopsy information and follow up 
recommendations; (2) a personalized referring physician letter with or 
without clinical diagram, photograph, and/or photomicrographs containing 
all relevant biopsy information and follow up recommendations, but also 
including a duplicate pathology report with the referring physician's name 
noted, and (3) patient information fact sheets, regarding which the 
clinician decides what patient information is included on their education 
fact sheets on different diagnosis, wound care sheets, etc. 
These and other objects of the invention will become apparent to one 
skilled in the art from the following more detailed disclosure of the 
invention.

DETAILED DESCRIPTION OF THE INVENTION 
Referring now to the drawings, FIG. 1 shows a sheet onto which the basic 
pathology report of the present invention is prepared. In a preferred 
embodiment of the invention, sheet 100 consists of a standard page, a 
portion of which is coated with label material. The top portion 101 of 
sheet 100 is normal paper for printing, and the bottom portion 102 of 
sheet 100, preferably approximately one-third or one-fourth thereof, is 
formed from adhesive material such that it is configured for multiple 
labels 104. Such material can typically have wax backing to allow for easy 
removal of labels 104. In addition, bottom portion 102 of sheet 100 is 
separable from top portion 101 by a tear line 103, such as a perforation 
or a score line, so that it can be easily removed from top portion 101 by 
tearing along tear line 103. Thus, once labels 104 have been peeled off, 
bottom portion 102 can be separated from top portion 101, leaving top 
portion 101 in the form of a standard 81/2.times.11 sheet of paper 101, 
which will become the pathology report. Tear lines 103 other than 
perforations and score lines may be used. Likewise, labels 104 could be of 
the self-stick variety or of the type that must be wet in order to be 
adhered. 
Since pathology findings to date never been placed on labels for 
application to other documents and files, printing the pathology report on 
a specially configured sheet of paper as shown in FIG. 1 is even more 
unique, less prone to error and provides more rapid filing and 
organization. The size of the portions of sheet 100 and the configurations 
of labels 104 can be altered to accommodate different sizes and numbers of 
labels according to the needs of the clinician, as shown in FIGS. 2A-C. 
FIGS. 2A and B show embodiments of pathology report sheets 200 whose top 
portion 201 in the standard 81/2.times.11 U.S. paper size, and FIG. 2C 
shows an embodiment of the pathology report sheet 200 whose top portion 
201 has a slightly smaller size. Of course, other embodiments could be 
shown having top portion 201 in larger size. Each of FIGS. 2A, 2B and 2C 
shows labels 204 with different sizes and in different configurations. In 
the preferred embodiment of the invention, the pathology report form will 
have several different size labels on the bottom portion of the sheet. It 
should be noted that FIGS. 1 and 2A-C show embodiments having only 
representative label configurations, which could also be customized in 
number, size and shape as desired by the clinician. FIG. 2D shows report 
sheet 200 on which labels 204 are configured in an L-shape such that one 
or more labels are "attached", such that more than one type of information 
or data can be provided on one label 204. Thus, the clinician would only 
have to apply one labels 204 to the client chart, rather than several as 
might be the case with FIGS. 2A-C. 
In addition, sheets 200 may be equipped with tear lines in addition to tear 
line 203 that separates bottom portion 202 from top portion 201. Sheet 200 
could also be configured to have tear lines, such as tear line 213 in FIG. 
2A and tear line 223 in FIG. 2C, that cut across bottom portion 202 so as 
to allow only part of bottom portion 202 to be detached from top portion 
201 once some of labels 204 have been removed. This will allow some of 
labels 204 to be left attached to the biopsy report (upper portion 201 of 
sheet 200) for later use, as described below. 
A preferred embodiment of the pathology laboratory biopsy report sheet 300 
for use in dermatology is shown in FIG. 3, and has a top portion 301 and a 
bottom portion 302. The main 81/2.times.11 inch pathology report, i.e., 
the upper portion 301 of biopsy report 300, contains information such as 
the name, account number and location of the physician, the date the 
report was printed, the patient's name and personal data, the date of 
biopsy, the site of the biopsy, biopsy gross and microscopic descriptions. 
The main report 301 could also include special clinician or office 
information, patient comment, identifying features of the patient, and 
descriptions of the diagnosis and type of follow-up required. The 
pathology report form 301 also preferably includes an indication by either 
number or letter of the biopsies requisitioned and performed at that time 
in order to facilitate easy marking of the different bottles for this 
patient specimens. Thus, the reports could be labeled 1 of 2 and 2 of 2 
(or A of B and B of B) in order to advise clinicians of the number of 
reports filed. Furthermore, report 301 could also include a clinical 
photograph 320, in the form of an actual picture, either two-dimensionally 
or three-dimensionally, of the biopsy site on the patient as well as a 
photomicrograph 321, also known as a digital histology photograph. A 
clinician can, of course, add additional information to the form as 
desired, as described below. 
The report form 301 may also have an anatomical diagram 322 showing the 
exact site of the biopsy in order to pinpoint the location more accurately 
than a mere description. Diagram 322 could be any one of various body 
parts, as shown in FIG. 4, depending on the area of specialty of the 
laboratory and the area biopsied. Drawings of any of these body parts, and 
of course others that are not shown here, might appear on a typical 
pathology requisition form that is used by a clinician for instructing the 
laboratory as to the exact site of the biopsy to be performed, such that 
the physician would indicate on the requisition form the site of the 
biopsy to be performed, and this diagram would be reproduced on the biopsy 
report. Biopsy report 301 shown in FIG. 3 is easily adapted for different 
fields of medicine by using different anatomical diagrams. Various options 
for this diagram are discussed below. However, should the clinician desire 
a pathology report without a diagram, one can also be provided. 
A preferred embodiment of the pathology laboratory biopsy report sheet 300 
shown in FIG. 3 also has bottom portion 302, which may be detached from 
top portion 301 along tear line 303, as described above with reference to 
FIGS. 1 and 2A-C. Bottom portion 302, as discussed above, has several 
labels 304. In a most preferred embodiment, bottom portion 302 of report 
form 300 has two labels 330 having summary biopsy reports pre-printed 
thereon. Each of labels 330 typically measures anywhere from a little less 
than 3 cm to about 4 or 5 cm in height by about 9 cm or more in width. The 
typical biopsy report label 330 includes key information from the biopsy 
report 301 that is required by the clinician but omits information that is 
not essential for the patient's chart. Report label 330 will typically 
include the patient's name, home and/or work telephone numbers, the date 
the biopsy specimen was obtained, accessioning number, specimen number, 
slide number, anatomical site where the specimen was obtained, the 
specific pathological diagnosis and any specific notes the pathologist 
made, as well as the clinical recommended follow-up treatment category. 
All this information is, of course, already included in the main pathology 
laboratory report 301. If the clinician requires additional or less 
information, such can also be provided. 
In a most preferred embodiment, bottom portion 302 of report form 300 also 
has additional labels thereon, in different shapes and sizes in order to 
accommodate whatever information or purpose is desired by the clinician. 
For example, as shown in FIG. 3, bottom portion 302 could have label 331 
showing an anatomical diagram of the precise site of the biopsy, similar 
to or exactly as the anatomical diagram 322 shown on the main biopsy 
report 301. Additionally, labels 332 could be prepared in specific size 
for use with medicine bottles so that the clinician who prescribed 
medicine for the biopsied patient will have medicine bottle labels readily 
available for use. The combination of labels 304 for specimens together 
with a pathology report 301 encompassing specific chart and patient 
information pre-completed out using customized computer software permits 
the system of the invention to generate a variety of different labels, 
with information desired by the clinician. 
The label configurations can be organized to create biopsy labels for 
future biopsies or other tests including cultures and sensitivities, 
fungal tissues, etc. These labels may be used at later dates for fungal 
cultures, bacterial strains, cultured sensitivities etc. to speed office 
protocol and decrease the likelihood that the specimen may go unlabeled or 
improperly labeled. Additional labels are available for the patient's 
letter, a referring doctor's letter, a chart or other notations. Thus, 
bottom portion 302 of sheet 300 is provided with additional tear lines, 
such as tear line 313, so that the labels that are not used at that 
particular time can be left attached to top portion 301 and easily 
attached to pathology report 301. There is no need for paper clips, 
staples or removable stick-to notes using the system of the present 
invention. 
In most patient charts, the pathology report is in a different section of 
the chart than the written record and, hence, for each biopsy the 
physician must constantly flip back and forth between the written record 
and the pathology report, including a diagram, thereby creating the risk 
of serious error in matching up the correct diagnoses to the appropriate 
reports. Sometimes it is impossible to clearly access the necessary 
information due to stapling or sticking together of reports, etc. This 
aspect is particularly important when multiple biopsies have been 
performed on different dates of service, often in the same areas of the 
patient's body. 
The summary report labels 330, which are adhered directly to the patient's 
chart, for example, as shown in FIGS. 6 and 7, or a biopsy book, as shown 
in FIG. 5, allows for easier reading of the biopsy report. Also, when 
there are multiple biopsies, it is often difficult to determine which 
biopsy corresponds to which date of service and to which specific 
diagnosis. Hence, there is coupled to the summary report label 330 a 
diagram 331, with which one attaches the pathology label. This feature 
eliminates the possibility of mixing up the biopsy report on the label 
300. Also, unique to the pathology report labels 330 and 331 system of the 
invention is the attachment of a variety of pathology report labels, both 
with and without a diagram, photomicrograph, clinical photograph or 
superimposed overlay (discussed below) to the main pathology report 301. 
Hence, it is quite easy to file the report 300 provided. 
The laboratory report system of the current invention also includes a 
clinical follow-up treatment recommendation system. The preferred mode of 
this system is through a "flagging system" that is marked on the 
anatomical diagram of the biopsy report 300. This system identifies on the 
anatomical diagram those specimens and diagnoses that require immediate 
attention and, using color coding of the flags, indicates the category and 
severity of the diagnosis, such as normal (benign), inflammatory, 
infectious, pre-malignant and malignant. Each of these diagnoses is 
identified by a specific color, as shown in the color code chart 323 in 
FIG. 3, and carries with it implications of a specific follow up that is 
required. However, even within a particular color, such as a malignancy 
diagnosis, there might be differences of follow-up. For example, for a 
biopsy of basal cell carcinomas with involved margins, the report would 
state "Red--Needs Follow-up Treatment", while for malignant melanoma 
invading the dermis the report might state "Red--Needs Immediate Follow-up 
Treatment--Physician To Call Patient And Call Physician Immediately With 
Findings". There would be an additional category for biopsies that require 
a work-up but are otherwise benign. These flags provide an immediate 
indication of the results of the biopsy for use by the clinician and the 
medical staff in order to more accurately complete the follow up and 
treatment. Diagram 322 on report 301 shows a spot at the biopsy site and, 
using color key 323, identifies the diagnosis and the follow up required. 
As another feature of the system of the present invention, biopsy reports 
300 can be generated specifically by follow-up category with listings of 
specific patient names in order to further allow the staff to double check 
and ensure that each lesion has been appropriately treated and that each 
patient receives the recommended follow-up care and visits established. 
For example, some diagnoses may require only phone conversations with the 
patient, and the doctor will be able to follow up by telephone rather than 
during an office visit, thus saving time for the patient, doctor and 
staff. This flagging system is further assisted by color or shape coding, 
with malignant being in Red color, pre-malignant being in Pink color, 
inflammatory being Blue in color, Infectious being in Green and other 
benign entities being in Grey color. Clinicians may be able to change the 
color coding in the set-up module written in the controlling software, 
coding the report as desired to meet their specific needs or personal 
vision problems. The most common colors used would be as stated above, 
unless an additional category is required. 
Also, for a biopsy requiring follow-up, duplicate forms if desired by the 
clinician are created specifically for the ancillary staff, in order to 
serve as an additional check on the system. The controlling software for 
the report- generating system of the present invention can also be 
directed by the clinician who may want higher ancillary staff to get all 
reports or only some reports, such as only reports showing infectious, 
infectious and Red-need follow-up, or Red-periodic follow-up diagnoses. 
Furthermore, the controlling software for the report generating system of 
the present invention allows the clinician to specify what reports are to 
be classified into each of these categories, since there may be some 
difference among clinicians as to which diagnoses fit into each category. 
The control system, therefore, allows clinicians to be very specific and 
to have a computerized report generating system which allows them to 
double-check everything they do, with their own individual input 
determining how they want the follow-ups to be handled, treated and 
appropriately further followed-up. 
The follow-up flagging or coding system provided by the reporting system of 
the present invention is applicable to all clinical specialties and can be 
adapted for each specialty by using different wording. Thus, the follow-up 
system can be modified to be made specific to the clinician's needs. 
Typical follow-up flags and codes are as follows: (1) "General--No 
Follow-up": This means that the patient's underlying condition is such 
that the patient need not be examined again for some time. Obviously, 
however, the doctor must be informed by the patient of any new problems. 
(2) "May or May Not Need Treatment": In this situation, clinical follow up 
requirements must be specified by the clinician regarding possible 
removal, excision and further treatment of the condition. The patient 
often must be seen in follow-up in order for the clinician to make the 
decision regarding treatment. An example of this category is situation in 
which a physician must decide whether a mole has been clinically 
completely removed. This is because pathologists often write with regard 
to "milder" pre-malignant conditions a note stating, "If there is any 
aspect of the lesion remaining clinically, please excise, otherwise it can 
be followed." However, this determination can only be made in person, and 
a clinician cannot rely on the opinion of the patient. (3) "Needs Work-up" 
or "May Need Work-up": Such a case exists if it is unclear whether there 
is an underlying or systemic process. Discussion between the 
patient/physician may be required regarding the biopsy, which may reveal a 
systemic disease, therefore requiring further testing, such as blood work 
or other tests. The patient may also be seen in a conference setting 
between the patient and physician. Diagnostic conditions might include 
discord lupus erythematosus, xanthoma, xanthelasma, some cases of alopecia 
and other localized diseases that may have a systemic component. (4) 
"Needs close follow-up": This flag means that the patient must have a 
periodic clinician follow-up visit unless the situation changes, and the 
patient must keep the physician abreast of any changes in his/her 
condition. Other complicating conditions might include a per-leukemic, 
pre-lymphomas or evolving mycosis fungoides, or any similar situation, in 
which one must closely monitor the patient's situation. (5) "Red Periodic 
Follow-up": This code is indicative of a pre-skin cancer such as 
dysplastic nevus, congenital nevus, actinic keratosis, cutaneous horn, 
etc., which are generally examined on three-month to one-year intervals. 
The system could automatically generate a letter to the patient regarding 
the follow up visit and sent based upon any of these follow-up flags/codes 
at the recommended return interval. (6) "Red-Needs treatment": Immediate 
treatment is required, such as in cases of severe disease process, which 
need to be monitored closely. This code is usually indicative of a type 
cancer. Other codes include (7) "General-Needs Treatment" and (8) 
"Infectious", which also require follow-up. New codes are created or 
lumped together on a specialty need as well as to personalize for each 
physician. 
The notation of the biopsy site on the anatomical diagram of the current 
invention can function in several ways based upon the clinician's 
preference. One way is that form 300 is provided with an exact copy of the 
drawing of the body part that the clinician completed on one of the many 
anatomical templates that are provided as part of the typical pathology 
requisition form such as in FIG. 8 showing the different body parts. FIG. 
4 depicts images of the face 30, arms 32, legs 34, trunk 36, groin 38, 
scalp 39, ears 40, etc. and are specific to the multiple areas of the body 
where a clinician can obtain a skin specimen. These graphics are completed 
by the clinician and/or staff when completing the biopsy requisition and 
are labeled with letters, such as A, B, C or D, at the location where each 
biopsy is taken. The results of the pathology report are then printed onto 
the main pathology report 301 as well as onto the customized labels 304, 
either as text or as a diagram. Pathology labels 304 may then be peeled 
off bottom portion 302 of sheet 300 and adhered either into the biopsy 
book (shown in FIG. 5), on the patient's chart (shown in FIG. 6), or into 
patient's summary report (shown in FIG. 7) in front of the chart or other 
locations that would aid in treating patients. All these charting 
pathology labels, with and without a color-coded and shape coded diagram, 
photomicrograph or clinical photograph facilitate simple transmission of 
data and less risk of error with minimal work. The number, size shape and 
locations of labels 304 will depend on the physician/hospital standards as 
well as special studies or clinics requiring the information. 
This diagram allows the clinician to show the exact site of the biopsy form 
the biopsy date. The label can be demarcated in color to match the 
follow-up color coded system, as shown in color chart 232 in FIG. 3 and in 
FIG. 11. Alternatively, this diagram can consist of quadrants, or sections 
of anatomic areas, shaded, and will also be demarcated in color to match 
the follow-up color coded system or by diagnosis. The report and labeling 
diagram system of the present invention allows or immediate observation, 
for clinical summary reports, for a summary of all reports, for one report 
using an overlay system or even the summary of previous reports on the 
same site on the report. 
The pathology report diagram 322 will also be color-coded so that the flags 
on the biopsy report are preferably printed in the same color as the 
follow-up report flagging system. For example, an "A" (or a dot, or an 
"X", or whatever indication is used) which is a skin cancer would come out 
as a red "A"; a "B" that was a verruca may come out in a infectious color 
green; a "C" which is an actinic keratosis may come out in pink; and a "D" 
which is a benign nevus would come out in black. These colors match the 
colors that will be used in printing out the labels as well as on the 
pathology report. This color-coding allows for easy visualization and for 
identification of the disease process at a glance. Accordingly, the 
Red-Follow-up or Needing Treatment flag should be in red, Periodic 
Follow-up flag should be in pink, General Follow-up flag should be in 
black, and Infection should be in green for ease of interpretation. 
(Unfortunately, due to the nature of the black-and-white drawings 
submitted herewith, these color indications cannot be clearly shown in 
FIG. 3. 
Even with all the reports hereinbefore provided, it often very difficult 
for a clinician to determine the exact location of the biopsy on the 
patient's body, especially if the patient has waited several weeks to 
return or if there are multiple biopsies, scars and/or rashes in the area. 
The present invention also provides for a novel system for indicating the 
exact location designated, called Specific Anatomic Mapping of the Biopsy 
Site. This procedure is extremely helpful in identifying the site of the 
biopsy, i.e. where the biopsy was obtained, and allows for the appropriate 
location of the biopsy site and the treatment of that biopsy site. Without 
specific site identification, many clinicians had been forced either to 
follow a small skin cancer until it grows larger or to treat the general 
area with a more diffuse treatment--such as cryosurgery--due to the fact 
that the exact location of the biopsy is not specifically identified. 
Alternatively, and more preferably, the diagram of the body part which is 
the subject of the biopsy can be presented in chart form divided into a 
grid having many small "quadrants". For example, as shown in FIG. 9, the 
face 30 depicted in FIG. 4 is divided up into may quadrants for easier 
identification of the precise site of the biopsy. In addition, specific 
parts of the face can be further subdivided into quadrants, for example 
the nose, as shown in FIG. 10, which is subdivided into many quadrants. In 
this embodiment of the diagram on report 300, only the quadrant in which 
an "X" is placed by the physician on the requisition form, denoting the 
location of the biopsy, is shaded on diagram 322 of biopsy report 300. For 
example, if the "X" were placed in quadrant no. F-10 denoting that 
quadrant as the biopsy location, only quadrant no. F-10 would be shaded on 
diagram 322 of biopsy report 300. This allows for clear visualization of 
the specific area, and also allows for better and clearer summary reports, 
as will be discussed below. The clinician will choose which of these two 
methods of diagramming will be presented on diagram 322 on report 301 and 
on printed labels 304 that are generated by the system of the invention. 
"Quadranting" is particularly helpful in certain specialties like 
gastroenterology and urology, in which the exact site is not reproducible 
and not known and, therefore, does not imply a specificity that is not 
reproducible or realistic. 
The system of the present invention is capable of allowing the clinician to 
receive some of the reports printed one way and some of the reports 
printed other ways. Summary reports are perhaps generally better prepared 
using the multiple quadrant technique, since such a summary report, which 
can be in addition to the summary reports provided in the front of the 
chart, could be in the form of a diagram which summarizes all skin cancers 
on this person's body. If a patient has had two basal cells in one 
quadrant, the color in that quadrant would be a deeper shade of red, 
further specifying the fact that multiple basal cells have occurred in 
that quadrant. A note underneath the diagram can specify, for example, 
quadrant no. 34 with two basal cell carcinomas and their dates, or 
quadrant no. 34 having only one basal cell and quadrant no. 3 having had 
four basal cells, resulting in a much deeper area of red or with stripes 
denoting multiple biopsies of a malignancy in this area. Such a report 
could be generated with and without pre-cancers noted and with or without 
other benign conditions noted, as desired by the clinician. 
The system of the invention is capable of producing reports on benign 
conditions diagnosed, pre-malignant conditions diagnosed and malignant 
conditions diagnosed as three separate reports. The system is also capable 
of producing a separate report that combines pre-malignant conditions, 
super-imposed by quadrants if desired or by overlay system by site. Such 
combined reports can also be super-imposed by letter or dot or symbol 
designation, according to a color key as illustrated in FIG. 11 and as 
shown in FIGS. 12A and 12B, as the clinician desires. The dot method using 
deeper colors or differing patterns for superimposed biopsy sites may be 
more preferable to use of letters, however, because one letter may be 
superimposed on another, causing confusion and making it difficult to 
visualize. Other clinicians may only be interested in the location of 
biopsied infectious diseases or by any category of disease, location or 
follow up. The advantage of the specific designation system is that it can 
be applied to in the exact location. 
The colored or lettered biopsy flags 323 are generated onto body part 
diagram 322 of report 300 by digitizing the data provided in the diagram 
on the requisition form or by taking the biopsy site from the software in 
the computer. The biopsy site quadrant or exact location can be digitized 
into the computer either by scanning technology or through photographic 
technology using either a digital camera or video system or by any other 
known or acceptable method. Using any of these techniques, the diagram can 
be digitized and then imprinted onto the label 331, using either the 
"quadrant" or "exact" approach, as well as onto diagram 322 of main 
pathology report 301. It should be noted that scanning data or a picture 
yields a very close approximation but not a 100% identical image, as 
images may not be lined up exactly. Obviously, as computer technology 
advances and solves this problem, the system of the invention can be 
upgraded to minimize this problem. However, in the interim, precautions 
must presently be taken to minimize this problem using specialized 
software avoiding both scanning and photographic techniques. Alternatively 
staff can transpose the site into the computer exactly or by quadrant 
using the rows and columns or using pre-drawn diagrams of each site to 
match and confirm the exact site. Special line-up procedures and 
safeguards prevent placement of the markings in the wrong area. 
As briefly discussed above, with reference to FIGS. 5-7, the locations of 
the different places where pathology report labels 330 and/or diagrams 331 
are to be affixed are: 
1. The clinical chart: The clinical chart is shown in FIG. 6 is the area in 
which the physician, nurses, and staff write their notes, any phone calls 
or any other messages that are dictated into a permanent record, which is 
part of the patient's permanent chart and which is obtainable by law when 
the patient changes physicians. The clinical chart is also the place where 
a notation of biopsies and their treatment is usually first made after a 
physician receives a pathology report. Most physicians use the clinical 
chart as their most important documentation area, and this is where all 
areas of treatment, as well as medications, are also noted. Until 
recently, the only way to note the results of a pathology report in the 
chart has been by writing it by hand. There had been no way to note the 
exact location of the biopsy except by using an independent drawing that 
was never directly matched to the diagram the clinician had given to the 
laboratory on the requisition form. Therefore, the diagram of the biopsy 
location that was drawn for the laboratory was not the exact same diagram 
that was inserted into the chart, if there was a diagram at all. 
2. The second place where a pathology report label generated through the 
system of the invention will be placed is in the biopsy book, as shown in 
FIG. 5. The biopsy book is where the physician notes the date of service, 
the patient's name, the doctor performing the service, the site and 
clinical impression, the biopsy results, and perhaps other less crucial 
information, including insurance information, identification of medical 
assistants noting or assisting in the procedure. One important column in 
this book which some physicians include is "treatment required". As part 
of the labeling system of the present invention, the inventors have also 
devised a specialized, customized biopsy book that accommodates the 
labeling system so as to allow for easy set up of the biopsy book and for 
rapid and careful treatment, as it also accommodates the follow-up system 
employed elsewhere in the system. The follow-up wording as well as the 
color coding of the biopsy label allows the staff to warn the physician 
that a biopsy location still needs to be treated. This is in addition to 
those same warnings that will appear in the chart, which is what the 
physician usually sees. The biopsy book serves more as a back up and, once 
a lesion is treated, staff will then note that fact in the biopsy book 
also. Alternatively, all information could be included on the label such 
that no information has to be transcribed by hand into the biopsy book at 
the time of biopsy. 
The biopsy book which is another feature of the system of the present 
invention has been formulated, as has the summary report, specifically to 
accommodate the pathology peel off label. Such a biopsy book has not 
previously been available to the clinician. 
3. The third place where a pathology report label generated through the 
system of the invention can be placed is in the patient's summary chart, 
shown in FIG. 7. The summary chart is a summary of all biopsies and is 
placed in the front of the patient's main chart, allowing for rapid review 
of all the important diagnoses that have been biopsied to date, thereby 
saving a great deal of the doctor's time in reviewing the patient's chart 
and reducing risk of missing an important diagnosis. It also allows for 
less risk of missing an early recurrent cancer, since the clinician is 
better able to examine all specific areas in greater detail under higher 
magnification, as normally an entire body may not be observed under high 
magnification and only the specific suspicious areas, such as where the 
cancer has occurred, are observed. Extra attention is naturally given to 
previously involved sites. 
Few doctors offices presently use a summary report of biopsies due to the 
tremendous amount of time required to write a summary by hand. However, 
given the availability of pathology report labels, either with or without 
a diagram, it is fast and easy to perform this task. Alternatively, 
monthly, quarterly or periodically as desired, a summary report of 
pathology labels can be created by various categories as determined by the 
clinician. A summary report can be created with or without an accompanying 
clinical diagram, photograph, or photomicrograph for pre-malignant or 
malignant cancers. These patient summary charts, if kept near the patient, 
serve as an immediate aid to better examination of patients. 
Alternatively, on a regular basis, for example quarterly or yearly, a list 
of labels can be generated summarizing only those malignant cancers, with 
or without pre-malignant, as desired by the clinician. Other types of 
follow-up can have a separate page or be included on the same summary 
sheet. For example, a summary report just for skin cancers with or without 
any diagnoses could be generated. Similarly, the labels for skin cancers 
could be printed in such a summary report with the occurrence of skin 
cancers in chronological order from top of the page to the bottom, or the 
system can print a summary report directly onto paper without printing 
labels, thereby saving a step, as well as time and effort. The summary 
report page can be configured so that the left side has a list of the 
biopsies and the right side has anatomic sites either drawn by hand, using 
the labeling system diagram or using the anatomic quadrant system referred 
to above for the "exact" site. The patient's summary chart is further 
sub-divided by diagnostic category and can be prepared for malignancies 
and pre-malignancies or any other category specified by the clinician. In 
the chart section, the diagram may be attached to the label, as shown in 
FIG. 2D, so that the two cannot be separated and thus cannot be confused. 
If so desired by the clinician or if separated patient information and 
both prevent risk of confusion. 
4. The fourth place where a label with a diagram generated by the system of 
the present invention normally might be used is in the summary chart 
reports. A patient summary chart report can be an active summary chart, if 
one of the extra pathology report labels is used specifically for disease 
category malignancies or by flag follow up category, e.g., "General--No 
Follow-up". The clinician could set up the report either way or in 
multiple other ways. 
The summary chart reports are one of the fastest ways to visualize a 
specific region or any specific problem. There are many alternative 
configurations and different ways to present the information. In one 
preferred arrangement, reports are presented on the same page by date 
order, in the same size as the summary using either the segmented or exact 
dot approach, with the diagnosis and dates noted elsewhere 330 on the page 
(see FIG. 13). Other optional configurations can incorporate the 
visualization of the summary report for that body part only or possibly 
even all body parts, also noted by time sequence (see FIG. 14). In one 
alternative presentation, one might have a summary of all affected sites. 
Alternatively, small replicas of the original diagrams using either exact 
or quadrant mode methods could be presented along the side of each summary 
or original biopsy report. Namely all clinical diagrams of FIG. 14 could 
be shown in color-coded format along the bottom row of man pathology 
report 301, as shown in FIG. 3, where the signature and overlay diagrams 
are presently noted. In another alternate arrangement, each diagram with a 
replica of previous diagnoses presented on bottom could be presented on a 
full page. All alternate arrangements can be produced either using the 
quadrant or exact technique diagram methods on pathology report 301 or on 
pathology labels 304. 
The labeling system of the invention can also be effectively utilized for 
fungal cultures, blood tests and for other diagnostic tests. In one such 
embodiment, the fungal culture is written with a triplicate label and, 
after instituting the KOH, one label is put in each of the chart, the 
fungal culture book and the fungal culture bottle, until two weeks later 
when the results are noted. The technician then merely needs to note the 
final result on each of the three labels. This allows for less risk of 
lack of follow-up as well as more accurate, faster and less error-prone 
charting. 
For blood work, perhaps only the abnormal results are placed on the label 
for entry into the chart. This label of abnormal or of a grouped 
test(e.g., cholesterol-related lab tests) could easily be placed on the 
chart from the page of all lab tests. The blood test results would look 
similar to next standard reports even designating also in the main report 
advanced blood test value and/or divided group tests. However, at the 
bottom or top or side of the sheet would be abnormal results or special 
lab grouping which could then be peeled off to the chart and tear off that 
section. Additional labels could be kept to match future blood vials, 
cultures or other purposes as described previously for pathology labeling 
system. Similarly, a lab summary sheet for the patient's chart and/or 
summary reports would be two other located n abnormal blood test, and any 
blood tests that are being followed in a patient. Any and all features of 
the pathology labeling system would also be incorporated to the blood test 
(a type of chemistry pathology) pathology labeling system. 
In order to use the entire pathology labeling system of the invention 
appropriately, the physician is given various options during the set-up 
phase, i.e., as to which of the diagnoses would be matched up to which 
follow-up system specifically for themselves, what colors are to be used 
for the follow-up system, and various other choices to allow for 
specificity and flexibility of the system for that clinician. The system 
of the invention will save users countless hours and will save the 
physician countless time having to review a chart or perform an 
examination. It will also eliminate numerous errors in the treatment of 
improper locations as well as allow the physician to develop a better 
methodology for reviewing a patient chart and determining the follow-up 
for the specific cancers and other important areas to be treated and 
followed-up. The labeling system with a diagram gives the physician the 
flexibility to look for either the exact site or the important anatomic 
quadrants that has the greatest number of the category (e.g., "Red-Need 
Follow-up" treatment category) of diagnoses that would require additional 
follow-up. And, since the pathology label report is adjacent to the 
anatomic site diagram, the clinician can see exactly the area that the 
report is referring to (see FIG. 3). Further, on each label there is 
provision for a notation to designate which quadrant it relates to and 
which of the anatomical templates that were used; For example, "Q37" means 
quadrant 37 on that specific template. Therefore, when the system is used 
to summarize the diagrams, one on top of the other (overlay system) and 
five or six different quadrants of involved area (e.g. Red-category) 
appear, the clinician would be able to quickly determine to which biopsy 
each report was related. A number can be added (e.g., D7-11) to refer to a 
specific date of service and diagnosis to be listed elsewhere on the label 
and/or pathology report. 
If two biopsy reports are related to the same area, that area would have a 
different demarcation (e.g., such as a deeper red or striping). Two of the 
biopsy reports would therefore be designated in the same quadrant in the 
same diagram, hence, accounting for its darker color, or striping. Another 
option would be a summary overlay of data by clinical follow up or for a 
specific diagnoses or desired (e.g., malignant melanoma or all types of 
BCC and SCC as a group) for that body part location. 
In summary the overlay of scanned diagram can work as follows: 
The requisition form (FIG 8.) has a diagram of the anatomical site. The 
client's office must indicate on one of these anatomical sites the exact 
biopsy site. This can be done by either placing a dot, a letter, or an "X" 
on the site of the biopsy. The diagram will be scanned, photographed or 
data entered into the computer. Depending on the diagnosis category (e.g., 
pre-malignant, malignant etc.), the color of the marking will be 
determined (see previous color-coded category descriptions) for specific 
follow-up flag coding. 
If there are multiple biopsies done over any period of time on the same 
site diagram, such as shown in FIG. 12B, all of the previously-entered 
diagrams are used for that site. At the client's request, the diagrams, 
diagnoses, diagnostic category or flag follow-up category for only certain 
specific time periods could be superimposed onto the labels and labeling 
system as illustrated in FIGS. 15A,B. The doctor may also be allowed to 
perform these functions themselves from their offices in an interactive 
mode. If more than one biopsy is located immediately near another, such as 
within the same quadrant in FIG. 15A, that quadrant will print out on the 
label in a darker shade of the same color 129 in order to indicate 
multiple malignancies in the same area. Other means could be used to 
indicate multiple malignancies in the same area, such a asterisks, 
stripes, checks, waved lines or other patterns 130. 
This system can also be used for only one diagnosis, for all cancers or for 
only noncancers or combinations thereof, or by clinical impression. 
Alternatively to the quadrant system, an exact dot system can be used such 
that the exact spot of the biopsy site is noted in color coded categories, 
as shown in FIG. 15B. All other previous statements of overlay apply. In 
rare occurrences where two dots lie in the same area, there would be 
additional symbols, such as discussed above. 
Another symbol will be used to indicate a pre-malignant lesion which is 
being monitored for change, to indicate changes seen on continued 
examination at future dates. This can then be incorporated into all 
regular diagrams, summary reports or overlays at the clinician's 
preference. This clinical diagnostic tool, e.g., an open circle or 
triangle or other shape, as desired, in contrast to the same shape filled 
in, would easily be visualized and separated from previously-biopsied 
areas. These could have their own color or be made pink for pre-cancer. 
This new method of following the clinical examination would allow the 
physician to clearly see the relationship between the biopsy site of that 
particular visit either by itself or as part of an overlay diagram, as 
shown in FIG. 15. This allows not only for more careful checking of areas 
with confirmed diagnoses of all pre-cancers and cancers (never previously 
done) but also of any and all lesions suspected by the physician of being 
cancerous, so that the areas also have maximal observation. This melding 
of the clinical reporting with the pathology reporting on one form is a 
major advance in the care of patients, particularly when used in the 
overlay mode. The system can be refined for open circles to mean a 
specific diagnostic category and diagnosis (e.g., actinic keratosis or 
pre-cancers) and an open triangle could mean verruca or viral, etc. 
In addition, a system for determining whether certain lesions previously 
biopsied are worsening in condition over time is being developed. This is 
especially helpful in monitoring dyplastic nevi, wherein a rating of 1 to 
10, such that 1 is least suspicious and 120 is most suspicious, can be 
developed. In this example, two dyplastic nevi lesions in the patient's 
left cheek would be biopsied, since they have changed the most since the 
patient's last visit. This clinical monitoring system can be alone within 
a computer for pathology labeling. Future enhancements will show the date 
when first detected, how much has changed in the rating systems and other 
features. 
They can therefore have a "peel off label" score sheet of their diagnoses 
on a daily, weekly or monthly basis. Built into the program will be a 
study of the clinician's clinical impression vs. the actual results. This 
can also be used to compare one clinician against others in the practice's 
clinical impressions vs. actual biopsy results to keep score as to how 
often the clinician's first number of impression (e.g. 1.sup.st, 2.sup.nd, 
3.sup.rd, the impression was accurate). This information can also be made 
available to an insurance company with the clinician's permission in order 
to show how good the doctor is in correctly diagnosing diseases. 
Other parameters can also be measured. For example statistics could be 
generated to determine how often the clinician did not go deep enough in 
his initial biopsy probe, the percentage of inadequate margins, how often 
a clinician misses a specific cancer diagnosis, whether the clinician is 
more accurate in diagnosing people of certain ages, genders or races or 
diagnosing certain parts of the body than others, the site at which most 
clinician's give the wrong clinical impression, whether the size varies 
for the stated size, etc. One could easily compile a weighted or 
non-weighted statistical report based upon criteria felt to be more 
important clinically. In addition, overall evaluations of physicians based 
upon on the scorecard labeling system could be generated periodically in 
order to rate the physicians' proficiency. 
The labeling system of the invention and clinical follow-up by disease 
process can function on a stand-alone PC system. Appropriate software 
could be created such that the requisition form has diagrams templated 
with and/or without quadrants, prints on special laser paper with 
specially configured print labels attached, and bears the necessary 
follow-up system. The physician can also be allowed to change the labeling 
system or categories in specific prearranged choice parameter to meet 
their specific patient needs, either on the PC or via remote connection, 
such as modem or internet. 
This invention also contemplates the following: 
1. A laboratory labeling system for generating diagram which specifically 
designates by exact site or quadrant method the location of the lesions. 
This will be performed on each case. In addition this can be used as an 
"overlay" system with superimposition of previous pathology diagram over 
designated time by site. This can be farther separated (interactively by 
the lab a clinician) by diagnosis, clinical impression, disease category. 
It can also be used as an overlay of all patients or a category of 
patients utilizing the same diagram and be subdivided by any category 
desired (e.g. category of disease, race, age sex etc.). The overlay system 
can work by either the "exact" dot system or by "quadrant" overlay as 
discussed. This overlay system can be put into our 3-D 3 dimensional 
diagnosis which are being developed, similarly, of course regular diagram 
labels can be put into the 3D diagram. The 3D diagram would then be 
incorporated also on the requisition forms. 
2. A laboratory labeling system for generating pathology reports which 
generates a clinical diagram supplied by the clinician to be added for 
documentation in the chart or other location. 
3. A laboratory labeling system for generating pathology reports with 
labels to be customized by the client for other uses like labels with 
patients name for blood work, fungal culture other uses contemplated 
include labels for letter for patient (i.e. patients home address) label 
for referring doctor (I.e. referring doctor address) label for patient 
requiring follow up (i.e. patient name and all pertinent phone numbers, 
with diagram comment and required follow up). Labels for comic release 
e.g. fanny fare, for children, teddy bear, I got through the biopsy: 
tracking labels for the outside of the chart for: 
1. To denote disease category of patient. 
2. Insurance company a payment problem. 
3. Allergic to - - - . 
4. Special needs, assistance. 
5. Special medication. 
6. Does not hear. 
Special information is dated so as the patients health changed, these could 
be updated. 
4. A laboratory labeling system for generating pathology reports which 
offer the clinical to attach on one label the diagram and/or 
photomicrograph and/or clinical photograph to the label of the results of 
the pathology report. 
5. A laboratory labeling system for generating pathology reports which 
allows for summary reports on label by categories chosen by the clinician 
in a chart format (e.g. skin cancer, or face, head neck over the last 20 
years). 
6. A laboratory labeling system for generating pathology reports of 
abnormal results only as in a blood test listing or labeling only the 
abnormal results. Also could have separate label for disease category e.g. 
cholesterol finding. This could have several labels including all blood 
tests results for cholesterol, only abnormal cholesterol results, results 
for normal only all to be placed in the chart or summary report sheets or 
other tables. Similarly their can have an overlay in chart, diagram, or 
other format of all previous abnormal or normal finding to be placed on 
label for chart which could be based on clinician performance. 
7. A laboratory labeling system for generating pathology reports which is 
to be used by the clinician, multispecialty, etc. to perform basic 
science/ clinical studies which require the information of the pathology 
report. (e.g. chart, diagram etc.) comparing their doctor or all doctors 
in data base patients or a specific region of the country. For example, 
the information could include the number of skin cancers on the ear by age 
and region of the country. Or related to eating a food country or the 
number of skin conditions that result from eating a particular food (data 
to be supplied by clinician) and a specific pathology diagram. This can be 
followed over time by the labeling system or summary sheet. 
8. A labeling system for pathology reports wherein the method of grossing 
the specimen in an excision can be placed on a label of the labeling 
system as part of the pathology report. Excision, also known as 
breadloafing, is a common manipulation of tissue for examination and can 
be manipulated onto a pathology report or onto the report labels, as shown 
in FIG. 16. Breadloafing can have evenly spaced excisions or could have 
excisions that are weighted according to the area of pathology. 
9. A labeling system for pathology reports in which the clinician can 
decide in a interactive mode with the laboratory pathology labeling system 
software and/or administrator to change aspects of the labeling system to 
suit their specific needs (e.g. size of report, color, fonts, clinical 
information including the addition of information and data, demographics) 
of information to be included on the labeling system. 
It will thus be seen that the objects set forth above, among those made 
apparent from the preceding description, are efficiently attained and, 
since certain changes may be made in the constructions set forth without 
departing from the spirit and scope of the invention, it is intended that 
all matter contained in the above description and shown in the 
accompanying drawings shall be interpreted as illustrative and not in a 
limiting sense. 
It is also to be understood that the following claims are intended to cover 
all of the generic and specific features of the invention herein described 
and all statements of the scope of the invention which, as a matter of 
language, might be said to fall therebetween.