US20140244283A1

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Publication number: US20140244283A1
Application number: US14/188,271
Authority: US
Inventors: Sidney P. Smith
Original assignee: Complete Consent LLC
Current assignee: Complete Consent LLC
Priority date: 2013-02-25
Filing date: 2014-02-24
Publication date: 2014-08-28
Also published as: US20200321106A1; US11881303B2

Abstract

Current Electronic Health Systems and Government sponsored International Classification of Diseases (IDC-10) do not have the flexibility to describe diagnoses that are not clearly benign or cancerous and cannot relay recommendations from pathologist, radiologist, or other specialist. Software codes enable any specialty to efficiently communicate additional recommendations with time metrics to their referring sources. A Quality Assurance Module interface provides for communication with patients, physicians, referring specialist, etc. Default time metrics may be used with the QAM. Enhancing communication of recommendations and assuring all parties involved with patient care, improves safety and patients outcomes.

Description

CROSS-REFERENCES TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/768,612, filed Feb. 25, 2013, the entire content of which is herein incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

(NOT APPLICABLE)

BACKGROUND OF THE INVENTION

When patients present to their physician with a possible melanoma, the physician evaluates the concerning area and performs a biopsy. The biopsy is sent to a lab which, in turn, renders a diagnosis, and the patient is contacted and treated. The invention relates to automated quality control for pathology, surgery, and medical treatment. The system automates the entire process and adds time metrics to improve patient safety and coordinates all involved parties.

BRIEF SUMMARY OF THE INVENTION

In each field of medicine such as pathology, surgery, and radiology, etc., it is desirable to follow diagnosis, recommendations, and patients' follow up. The physician, surgeon, pathologist, and patients all need a mechanism to follow labs, specimens (including x-ray reports), or recommendations to demonstrate appropriate care is received.

A process and platform are described that enable physicians to communicate recommendations and referrals with time metrics accessible to all health care partners. Through point of origin scan codes for specimens integrated with the lab and the Quality Assurance Module, all parties are effectively informed of each step of the process, and safeguards are established to make sure all recommendations or referrals are completed. The process and platform may be used in all medical societies.

In an exemplary embodiment, a computer-implemented method of pathological quality assurance includes the steps of (a) generating a label for a specimen including patient demographics and a proposed diagnosis; (b) electronically sending with network communication hardware the patient demographics and the proposed diagnosis to a quality assurance module; (c) providing a lab receiving the specimen with access to the quality assurance module; (d) receiving a pathologist diagnosis and a recommendation code from the lab and importing the pathologist diagnosis and the recommendation code to the quality assurance module, where the recommendation code identifies any additional procedures needed and time parameters for completion; and (e) the quality assurance module identifying time metrics for follow-up activity based on the pathologist diagnosis and the recommendation code. A “specimen” preferably also includes an x-ray or any event which requires additional intervention and other lab processed information about the patient.

Step (a) may be practiced by generating a machine-readable code.

The recommendation code in step (d) may identify additional procedures including at least one of re-testing the patient, expanding a scope of testing, recommending patient follow-up visits, and recommending a referral to another specialist. In this context, the recommendation code in step (d) may further identify the time parameters for the recommended additional procedures. In one application, the proposed diagnosis is a melanoma, and the recommendation code in step (d) may identify additional procedures including at least one of re-excision of a lesion, excision of the lesion with a specific margin of skin, recommending patient follow-up visits, and recommending a referral to another specialist.

The method may additionally include the steps of (f) monitoring the follow-up activity and corresponding time metrics; and (g) automatically sending alerts when the follow-up activity does not take place according to the time metrics. In this context, step (g) may be practiced by first sending an email communication to the patient's care provider, then sending an email communication to the pathologist, then sending an email to the patient. When the patient does not respond to the email communication within a preset time period, the method may include generating a certified diagnosis letter to the patient.

The quality assurance module may communicate information relating to the specimen and a status of the pathologist diagnosis to the patient. In this context, the information relating to the specimen may include a date that the specimen was sent to the lab, a location of the lab, arrival date at the lab, arrival date for the pathologist diagnosis at the patient's care provider, date of patient notification of the pathologist diagnosis, additional recommendations or treatments, dates of future procedures, and dates of communications sent to the patient.

In another exemplary embodiment, pathological quality assurance is ensured for a specimen sent from a care provider office of a patient to a lab. A pathologist diagnosis and a recommendation code are received from the lab and imported to a quality assurance module. The recommendation code identifies any additional procedures needed and time parameters for completion. The quality assurance module identifies time metrics for follow-up activity based on the pathologist diagnosis and the recommendation code.

In yet another exemplary embodiment, a system for providing pathological quality assurance includes a computer processor that generates a label for a specimen including patient demographics and a proposed diagnosis, and a quality assurance module defined by software executed by the computer processor that stores time metrics for follow-up activities according to a pathologist diagnosis and a recommendation code. Network communication hardware communicating with the computer processor sends the patient demographics and the proposed diagnosis to the quality assurance module. A user computer communicating with the computer processor over a global network uploads the pathologist diagnosis and the recommendation code to the quality assurance module. The recommendation code identifies any additional procedures needed and time parameters for completion. The quality assurance module identifies time metrics for follow-up activity based on the pathologist diagnosis and the recommendation code. The recommendations and time metrics are customizable to the physician, group practice, specialty, nationally, etc.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects and advantages will be described in detail with reference to the accompanying drawings, in which:

FIG. 1 is a flow diagram showing the patient visit;

FIG. 2 is a Quality Assurance Module Coding System;

FIG. 3 is a default setting for ICD-10 codes;

FIG. 4 is a flow diagram showing the Quality Assurance Module; and

FIG. 5 is a detailed schematic of a computer system.

DETAILED DESCRIPTION OF THE INVENTION

With reference toFIG. 1, in the scenario of a patient presenting with a possible melanoma (1), the following protocol is followed. A nurse with a procedure tablet or the like (2) having diagrams representing the area to be removed such as a human figure, an ear, or a colon, etc. will electronically, upon touching with a pen, label the specimen as to right, left, and specifics as to the location on the body (3). Once the nurse touches the lesion diagram on the tablet, a specimen label in the form a scan code is created to place on the specimen, and simultaneously, information is sent to a computer interface that will communicate with the receiving lab (4). The information generated by the sending party includes the patient name, date of birth, patient demographics, and the physician's specimen number, location on the body, insurance information, and the physician's differential diagnosis. The receiving lab sends a specimen accession number that will be used to identify the specimen on arrival to the lab and be used to track the specimen at the lab (5). With the above information combined the, information is then sent to the Quality Assurance Module, the sending physician, the patient, and the receiving lab. The specimen is removed, and the label is affixed to the bottle (7). The specimens are placed in a sealed bag accompanied by a printed document that contains all the information generated by the sending physician and receiving lab all of which is contained on each specimen's scan code. Once the specimens are labeled with the scan codes, and the printed summary document is placed in the specimen bag, the information is sent electronically to the lab, QAM, physician, patient, and courier that specimens are ready to be delivered and processed (8). The specimen information delivered to the lab (12) is integrated with their software for processing the specimens with the accession number, information for billing, and for integrating with the QAM (9). The courier is able to use the scan codes generated to document delivery times of pickup and delivery (13). The information sent from the QAM (9) to the lab is integrated with their processing software to accession the specimen and for the pathologist to render a diagnosis (14).

The pathologist renders a diagnosis and recommendation which are sent to the QAM (15) via the Quality Assurance Module coding system (FIG. 2) (16) where the information is assessable on the Quality Assurance Module Interface (FIG. 4) (8) by the physician, pathologist, and patient. Traditionally, a pathologist renders a diagnosis and occasionally an additional recommendation would be written in the “fine print” in the pathology report. Unfortunately the “fine print” recommendations are overlooked and as not part of the formal diagnosis and are not recorded in an Electronic Health Record software system (EHR). This is a very serious defect in the current EHR systems.

There are many examples of how the “fine print” recommendations in pathology and radiology for example can have tragic outcomes for patients. If a patient has a pigmented mole removed to check if the lesion is a melanoma, the pathologist may only see a portion of the entire lesion, which under the microscope is benign or non-cancerous. The pathologist may note that the mole extends beyond what he can see and is worried that the part “next door” or not removed may be the melanoma. Surprisingly, the only diagnosis codes (ICD-10) Medicare has approved for the pathologist to use is Cancer or Benign. There are no codes that allow a pathologist to diagnose with recommend additional testing. Additionally, there is no communication tool to effectively deliver “fine print” or additional recommendations from pathologist to the referring physician or patients. In the melanoma scenario employing the software, the pathologist has unique codes to access that allows him or her to communicate that the mole examined is “Benign or non-cancerous” but he recommends additional excision, biopsy, or additional examination of the patient.

Radiologists face this issue every day with every test they perform. The mammogram is a tragic example of how this can have a fatal outcome for a patient. The radiologist may examine a mammogram which is normal but a small area may be of concern but not enough to diagnose as a “cancer.” The radiologist must convey a recommendation, but no codes are available to communicate with the ordering physician or patient that additional testing is necessary and at what interval.

The system has a unique set of codes selected by the pathologist, radiologist, or that are sent with the diagnosis defining any other specialist that are combined with the diagnosis codes to define additional recommendations (FIG. 2) (16). These unique codes reflect additional recommendations (17), time intervals (18), and referrals (19) for procedures needed and the time parameters for completion. In addition to the customizable codes there a group of standard QAM codes that are default metrics defined for each test (FIG. 3) (20). The additional recommendations with coding are integrated with the QAM for all parties to follow.

The basic format of the “fine print codes, or additional recommendations” is demonstrated inFIG. 2. The codes include a procedure recommendation (17) followed by a time interval (18) for completion and a referral recommendation (19) followed by a time interval (18). The procedures recommended vary by specialty such as pathology, radiology, etc. As an exemplary system, the pathologist may recommend several procedures after a biopsy such as recommending the patients have a follow up exam, biopsy, excision, excision with wide margins, or recommend sending additional specimens to a specialist (17). These codes are then combined with a numerical codes attached to a time interval line by day, week, month, or year. The pathologist for example could recommend a repeat biopsy one week from now, which as shown inFIG. 2, would be coded as 02.12/00.

The radiologist would have a similar arrangement of codes with procedures, a time interval, and referral recommendations. The radiologist may recommend a repeat procedure, plain films, CAT scan, magnetic resonance imaging, mammogram, ultrasound, biopsy (17) or other test. Additionally, a recommendation may be made for referral to another specialist such as a surgeon, oncologist, radiologist, neurologist, or other specialist (19). A radiologist may see a suspicious area on a mammogram and recommend a repeat mammogram in six months. The diagnosis would be a benign mammogram but the additional code would signify a follow-up exam, for example, 01.63/00. If the radiologist saw a lesion that needed biopsy by a surgeon within the week, another code would used, for example, 07.12/0112.12.

Each specialty would develop a standard set of codes to describe the procedures and the referral types to fully describe the specialist recommendation.

Specialties may establish default metric and recommendations for pathologists and radiologists to use based on the diagnosis or ICD-10 number. For example, in the scenario of the melanoma, a default setting could be that each time a diagnosis of melanoma is made, ICD-10 172.5, the system automatically adds codes recommendation of excision in three weeks, for example, 03.32/0.0.FIG. 3 demonstrates default examples of settings for a melanoma diagnosis and the recommendation of annual follow up visits and the default setting for a breast lesion recommendation of a six month follow up mammogram. In both examples, a diagnosis is made.

In both examples, the diagnosis ICD-10 code (21) is combined with a default setting (22), and this information is sent to the QAM (8).

FIG. 4 is the user interface called the Quality Assurance Module Interface (8) where the healthcare providers, patients, and others (23) communicate. Codes from the Quality Assurance Module Coding System (16) and the default settings (20) are integrated. All health providers are using the same interface, and all recommendations, referrals, and time intervals can be followed.

The recommendation codes are sent to the QAM module (8).

Additionally programmed with the QAM are standard time metrics specific for various diagnoses. For example, if one has melanoma, a time clock or metric is initiated allowing 10 days for the physician to contact the patient. If contact with the patient is not made, emails are sent to the physician, and after a certain amount of time, there is a direct email sent to the patient about the outstanding diagnosis. With reference toFIG. 4, for each step of the process, diagnosis of the specimen, notifying the physician, and notifying the patient documentation is recorded on the QAM (8) and communicated with the patient (23) and healthcare team (23). Occasionally, with some diagnoses, an additional procedure or referral may be recommended. That information is placed on the QAM with a time metric as to when the additional procedure is scheduled and what time frame the procedure should be completed with the resulting diagnosis (13). If these steps do not occur in a timely manner, the system automatically sends emails to the physician, the pathologist, the referral specialist and ultimately the patient. If the patient does not respond and the recommended procedure is not completed, a certified letter is generated electronically and sent to the patient closing the loop for the entire procedure.

The system notifies patients of each step their specimens take, keeping them informed along the process. Patients are notified when and where specimens are sent from the physician's office, date of arrival at the lab, date of arrival of the information at the physician's office, date of patient notification of the diagnosis, any additional recommendations or treatments, dates of future procedures, and dates of communication with certified letters. Additionally, proprietary metrics are used by the system to set the parameters for appropriate intervals in the process.

The surgical field also benefits from the QAM module. A diagnosis such as a colon polyp or bronchoscopy may require scheduled follow up visits or testing. Placing these recommendations on the QAM (8) module will assure compliance with the recommendations. The emergency room would benefit from a system following patient compliance for recommendations of following up with additional physicians or testing (8).

The Pathology Lab benefits by saving employee time and money not having to re-input data already recorded at the referring physician's office, having better documentation of result delivery to physicians and patients and follow up on recommendations. The referring physicians save time and money with the QAM standardized follow up, and patients benefit through continual contact which allows the process to improve communication and safety.

In the Radiology field, the process is similar to the pathology scenario. Patient demographics (4) are transmitted (7) with the x-ray order to the radiologist who performs the x-ray. The diagnosis rendered may require additional tests and recommendations. The additional tests or recommendations are placed on the QAM (8) with time metrics to assure they were completed. The system assures that patients receive recommended care.

The QAM may be located on the system servers in the “Cloud,” accessible by the lab, physician, patient, hospital, insurance company, government agencies and other healthcare team members (15).

The quality assurance process described with reference toFIGS. 1-4 is preferably a browser-based system in which a program running on a user's computer (the user's web browser) requests information from a server program running on a system server. The system server sends the requested data back to the browser program, and the browser program then interprets and displays the data on the user's computer screen. The process is as follows:

1. The user runs a web browser program on his/her computer.

2. The user connects to the server computer (e.g., via the Internet). Connection to the server computer may be conditioned upon the correct entry of a password as is well known.

3. The user requests a page from the server computer. The user's browser sends a message to the server computer that includes the following:

the transfer protocol (e.g., http://); and the address, or Uniform Resource Locator (URL).

4. The server computer receives the user's request and retrieves the requested page, which is composed, for example, in HTML (Hypertext Markup Language).

5. The server then transmits the requested page to the user's computer.

6. The user's browser program receives the HTML text and displays its interpretation of the requested page.

Thus, the browser program on the user's computer sends requests and receives the data needed to display the HTML page on the user's computer screen. This includes the HTML file itself plus any graphic, sound and/or video files mentioned in it. Once the data is retrieved, the browser formats the data and displays the data on the user's computer screen. Helper applications, plug-ins, and enhancements such as Java™ enable the browser, among other things, to play sound and/or display video inserted in the HTML file. The fonts installed on the user's computer and the display preferences in the browser used by the user determine how the text is formatted.

If the user has requested an action that requires running a program (e.g., a search), the server loads and runs the program. This process usually creates a custom HTML page “on the fly” that contains the results of the program's action (e.g., the search results), and then sends those results back to the browser.

Browser programs suitable for use in connection with the account management system of the present invention include Mozilla Firefox® and Internet Explorer available from Microsoft® Corp.

While the above description contemplates that each user has a computer running a web browser, it will be appreciated that more than one user could use a particular computer terminal or that a “kiosk” at a central location (e.g., a cafeteria, a break area, etc.) with access to the system server could be provided.

It will be recognized by those in the art that various tools are readily available to create web pages for accessing data stored on a server and that such tools may be used to develop and implement the system described below and illustrated in the accompanying drawings.

FIG. 5 generally illustrates acomputer system201 suitable for use as the client and server components of the described system. It will be appreciated that the client and server computers will run appropriate software and that the client and server computers may be somewhat differently configured with respect to the processing power of their respective processors and with respect to the amount of memory used.Computer system201 includes aprocessing unit203 and asystem memory205. Asystem bus207 couples various system components includingsystem memory205 toprocessing unit203.System bus207 may be any of several types of bus structures including a memory bus or memory controller, a peripheral bus, and a local bus using any of a variety of bus architectures.System memory205 includes read only memory (ROM)252 and random access memory (RAM)254. A basic input/output system (BIOS)256, containing the basic routines that help to transfer information between elements withincomputer system201, such as during start-up, is stored inROM252.Computer system201 further includes various drives and associated computer-readable media. Ahard disk drive209 reads from and writes to a (typically fixed) magnetichard disk211; amagnetic disk drive213 reads from and writes to a removable “floppy” or othermagnetic disk215; and anoptical disk drive217 reads from and, in some configurations, writes to a removableoptical disk219 such as a CD ROM or other optical media.Hard disk drive209,magnetic disk drive213, andoptical disk drive217 are connected tosystem bus207 by a hard disk drive interface221, a magneticdisk drive interface223, and anoptical drive interface225, respectively. The drives and their associated computer-readable media provide nonvolatile storage of computer-readable instructions, SQL-based procedures, data structures, program modules, and other data forcomputer system201. In other configurations, other types of computer-readable media that can store data that is accessible by a computer (e.g., magnetic cassettes, flash memory cards, digital video disks, Bernoulli cartridges, random access memories (RAMs), read only memories (ROMs) and the like) may also be used.

A number of program modules may be stored on thehard disk211, removablemagnetic disk215,optical disk219 and/orROM252 and/orRAM254 of thesystem memory205. Such program modules may include an operating system providing graphics and sound APIs, one or more application programs, other program modules, and program data. A user may enter commands and information intocomputer system201 through input devices such as akeyboard227 and apointing device229. Other input devices may include a microphone, joystick, game controller, satellite dish, scanner, or the like. These and other input devices are often connected to theprocessing unit203 through aserial port interface231 that is coupled to thesystem bus207, but may be connected by other interfaces, such as a parallel port interface or a universal serial bus (USB). Amonitor233 or other type of display device is also connected tosystem bus207 via an interface, such as avideo adapter235.

Thecomputer system201 may also include a modem or broadband orwireless adapter237 or other means for establishing communications over thewide area network239, such as the Internet. Themodem237, which may be internal or external, is connected to thesystem bus207 via theserial port interface231. A network interface241 may also be provided for allowing thecomputer system201 to communicate with aremote computing device250 via a local area network258 (or such communication may be via thewide area network239 or other communications path such as dial-up or other communications means). Thecomputer system201 will typically include other peripheral output devices, such as printers and other standard peripheral devices.

As will be understood by those familiar with web-based forms and screens, users may make menu selections by pointing-and-clicking using a mouse, trackball or other pointing device, or by using the TAB and ENTER keys on a keyboard. For example, menu selections may be highlighted by positioning the cursor on the selections using a mouse or by using the TAB key. The mouse may be left-clicked to select the selection or the ENTER key may be pressed. Other selection mechanisms including voice-recognition systems, touch-sensitive screens, etc. may be used, and the invention is not limited in this respect.

While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims

1. A computer-implemented method of pathological quality assurance comprising:

(a) generating a label for a specimen including patient demographics and a proposed diagnosis;

(b) electronically sending with network communication hardware the patient demographics and the proposed diagnosis to a quality assurance module;

(c) providing a lab receiving the specimen with access to the quality assurance module;

(d) receiving a pathologist diagnosis and a recommendation code from the lab and importing the pathologist diagnosis and the recommendation code to the quality assurance module, wherein the recommendation code identifies any additional procedures needed and time parameters for completion; and

(e) the quality assurance module identifying time metrics for follow-up activity based on the pathologist diagnosis and the recommendation code.

2. A computer-implemented method according toclaim 1, wherein step (a) is practiced by generating a machine-readable code.

3. A computer-implemented method according toclaim 1, wherein the recommendation code in step (d) identifies additional procedures including at least one of re-testing the patient, expanding a scope of testing, recommending patient follow-up visits, and recommending a referral to another specialist.

4. A computer-implemented method according toclaim 3, wherein the recommendation code in step (d) further identifies the time parameters for the recommended additional procedures.

5. A computer-implemented method according toclaim 1, wherein the proposed diagnosis is a melanoma, and wherein the recommendation code in step

(d) identifies additional procedures including at least one of re-excision of a lesion, excision of the lesion with a specific margin of skin, recommending patient follow-up visits, and recommending a referral to another specialist.

6. A computer-implemented method according toclaim 1, further comprising:

(f) monitoring the follow-up activity and corresponding time metrics; and

(g) automatically sending alerts when the follow-up activity does not take place according to the time metrics.

7. A computer-implemented method according toclaim 6, wherein step (g) is practiced by first sending an email communication to the patient's care provider, then sending an email communication to the pathologist, then sending an email to the patient.

8. A computer-implemented method according toclaim 7, wherein when the patient does not respond to the email communication within a preset time period, the method comprises generating a closed diagnosis letter to the patient.

9. A computer-implemented method according toclaim 1, wherein the quality assurance module communicates information relating to the specimen and a status of the pathologist diagnosis to the patient.

10. A computer-implemented method according toclaim 9, wherein the information relating to the specimen comprises a date that the specimen was sent to the lab, a location of the lab, arrival date at the lab, arrival date for the pathologist diagnosis at the patient's care provider, date of patient notification of the pathologist diagnosis, additional recommendations or treatments, dates of future procedures, and dates of communications sent to the patient.

11. A computer-implemented method according toclaim 1, wherein the specimen comprises an x-ray.

12. A computer-implemented method according toclaim 1, further comprising identifying with the quality assurance module referral recommendations and time metrics.

13. A computer-implemented method according toclaim 1, wherein the recommendation code comprises default coding sequences that reflect individual physician, practice group, medical society and national preferences.

14. A computer-implemented method of pathological quality assurance for a specimen sent from a care provider office of a patient to a lab, the method comprising:

(a) receiving a pathologist diagnosis and a recommendation code from the lab and importing the pathologist diagnosis and the recommendation code to a quality assurance module, wherein the recommendation code identifies any additional procedures needed and time parameters for completion; and

(b) the quality assurance module identifying time metrics for follow-up activity based on the pathologist diagnosis and the recommendation code.

15. A computer-implemented method according toclaim 14, further comprising:

(c) monitoring the follow-up activity and corresponding time metrics; and

(d) automatically sending alerts when the follow-up activity does not take place according to the time metrics.

16. A computer-implemented method according toclaim 15, wherein step (d) is practiced by first sending an email communication to the patient's care provider, then sending an email communication to the pathologist, then sending an email to the patient.

17. A computer-implemented method according toclaim 16, wherein when the patient does not respond to the email communication within a preset time period, the method comprises generating a closed diagnosis letter to the patient.

18. A system for providing pathological quality assurance, the system comprising:

a computer processor generating a label for a specimen including patient demographics and a proposed diagnosis;

a quality assurance module defined by software executed by the computer processor that stores time metrics for follow-up activities according to a pathologist diagnosis and a recommendation code;

network communication hardware communicating with the computer processor and sending the patient demographics and the proposed diagnosis to the quality assurance module; and

a user computer communicating with the computer processor over a global network, the user computer uploading the pathologist diagnosis and the recommendation code to the quality assurance module, wherein the recommendation code identifies any additional procedures needed and time parameters for completion,

wherein the quality assurance module identifies time metrics for follow-up activity based on the pathologist diagnosis and the recommendation code.

19. A system according toclaim 18, wherein the quality assurance module is programmed to monitor the follow-up activity and corresponding time metrics and to automatically send alerts when the follow-up activity does not take place according to the time metrics.