WO2017044691A1

WO2017044691A1 - Systems and methods for testing and treatment of allergies

Info

Publication number: WO2017044691A1
Application number: PCT/US2016/050876
Authority: WO
Inventors: Maurice Sean PUYPE
Original assignee: Advantage Allergy Services, Llc
Priority date: 2015-09-09
Filing date: 2016-09-09
Publication date: 2017-03-16

Abstract

Systems and methods of providing allergy-related medical services using inventory control methods, computer-mediated verification of antigens used in allergy testing and treatment, and visual matching of materials to virtual representations of the materials. The systems and methods describe allergy test kit preparation, allergy test scoring, penicillin allergy testing, compounding patient immunotherapy vial sets, recording immunotherapy progress, and other administrative processes.

Description

SYSTEMS AND METHODS FOR TESTING AND TREATMENT OF ALLERGIES

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic diagram illustrating the components and users of an allergy testing and treatment system of the present disclosure.

FIG. 2 shows a schematic diagram of various modules of an allergy testing and treatment system of the present disclosure.

FIG. 3 shows a flowchart illustrating a general process of using an allergy testing and treatment system of the present disclosure.

FIG. 4 shows a personal dashboard or control panel of an allergy testing and treatment system of the present disclosure.

FIG. 5 shows an inventory list view screen display of an allergy testing and treatment system of the present disclosure.

FIG. 6 shows an inventory detail view screen display for a non-antigen inventory item.

FIG. 7 shows an inventory detail view screen display for an antigen inventory item.

FIG. 8 shows a flowchart illustrating an antigen tracking process of the present disclosure.

FIG. 9 shows a flowchart illustrating a patient intake and screening process of the present disclosure.

FIG. 10 shows a perspective view of an antigen vial holder used to load an allergy testing kit.

FIG. 11 shows a screen display illustrating a virtual allergy testing antigen vial holder corresponding to the allergy testing antigen vial holder of FIG. 10.

FIG. 12 shows a flowchart illustrating an allergy testing kit loading process.

FIG. 13 shows an illustration of an allergy testing kit loading guide displayed over the screen display of FIG. 11.

FIG. 14 shows a close-up view of a portion of FIG. 13.

FIG. 15 shows the close up of FIG. 14 over a period of time illustrating screen changes occurring as antigen is loaded into an allergy testing kit reservoir.

FIG. 16 shows an illustration of an allergy testing scoring screen and a close-up view of a portion of the allergy testing scoring screen.

FIG. 17 shows a plan view of a tool used to measure and score patient reactions.

FIG. 18 shows a penicillin allergy testing screen layout of the present disclosure.

FIG. 19 shows a flowchart illustrating a penicillin allergy skin prick testing process of the present disclosure. FIG. 20 shows a flowchart continuing the penicillin allergy skin prick testing process of FIG. 19.

FIG. 21 shows an illustration of a penicillin skin prick test sticker.

FIG. 22 shows an illustration of a penicillin intradermal test sticker.

FIG. 23 shows a plan view illustrating a penicillin allergy testing rack.

FIG. 24 shows the penicillin allergy testing screen of FIG. 18 displaying a virtual penicillin allergy skin prick test sticker and penicillin skin prick test checklist details.

FIG. 25 shows the tasks tab details of the penicillin allergy testing screen of FIG. 24.

FIG. 26 shows the penicillin allergy testing screen of FIG. 18 displaying a virtual penicillin allergy intradermal test sticker and penicillin intradermal test checklist details.

FIG. 27 shows the task tab details of the penicillin allergy testing screen of FIG. 26.

FIG. 28 shows a display sequence for one row of task items of penicillin allergy intradermal testing of FIG. 27.

FIG. 29 shows a display sequence for the amoxicillin testing row task of the penicillin allergy intradermal testing of FIG. 27.

FIG. 30 shows a flowchart illustrating a penicillin intradermal testing process.

FIG. 31 shows a flowchart illustrating an amoxicillin challenge portion of the penicillin allergy testing process.

FIG. 32 shows a flowchart illustrating a patient immunotherapy vial mixing process.

FIG. 33 shows a flowchart illustrating a patient immunotherapy vial mixing process continued form FIG. 32.

FIG. 34 shows a perspective view of a bulk antigen vial holder.

FIG. 35 shows a plan view of the bulk antigen vial holder of FIG. 34.

FIG. 36 shows a perspective view of a patient vial mixing rack.

FIG. 37 shows a patient vial mixing screen.

FIG. 38 shows an antigen verification screen.

FIG. 39 shows a close-up view of a portion of virtual bulk antigen vial holder of the patient vial mixing screen of FIG. 37.

FIG. 40 shows the close-up view of FIG. 39 after determining that the barcode on the bulk antigen vial matches the antigen vial pulled.

FIG. 41 shows a sequence of one column of virtual patient vial mixing tray of the patient vial mixing screen of FIG. 37 as a user completes mixing tasks.

FIG. 42 shows an injection progress report screen.

FIG. 43 shows a flowchart illustration a patient immunotherapy injection process.

FIG. 44 shows an injection record screen. FIG. 45 shows the injection record screen of FIG. 44 with sample data input. FIG. 46 shows a flowchart illustrating an emergency response process of the present disclosure.

FIG. 47 shows a flowchart illustrating a patient billing process of the present disclosure. FIG. 48 shows a billing screen.

FIG. 49 shows a flowchart illustrating a purchase order process.

FIG. 50 shows a flowchart showing a receive purchase order inventory process.

DETAILED DESCRIPTION

The present disclosure relates to providing allergy -related medical services, namely, the administration of allergy testing and treatment in a clinic or medical practice. The disclosed systems and methods include, among other features, safeguards assisting adherence to allergy testing and treatment standards by individuals involved in the allergy testing and treatment medical industry. Such safeguards include computer-responsive guided preparation of antigen vial holders, allergy testing kits, and patient immunotherapy vial sets (along with general clinic inventory management) to avoid improper preparation of such items, alerting improper use of antigen vials when preparing allergy testing kits or patient immunotherapy vial sets, visual color matching of computer-displayed virtual representations of the items used in allergy testing, immunotherapy, etc., among other safeguards and features described further herein.

FIG. 1 shows a schematic diagram illustrating the components and users of an allergy testing and treatment system of the present disclosure. The systems and methods of the present disclosure are configured to provide patients (e.g., patient 105) with testing and treatment of allergies including environmental allergies, food allergies, penicillin allergies, as well as other ailments. The systems and methods of the present disclosure enable staff and physicians of doctor' s offices, clinics, and other healthcare institutions to allergy test and treat patients 105 using an electronic computing device and a computer application that guides users 110 (e.g., staff 115, physician 120, administrator 125) of a health care institution to implement proper allergy testing and treatment protocols. The term user is used in the present disclosure to refer to the individual that may be using the electronic computing device. From time to time, a more specific user type may be used herein (e.g., a physician, nurse, technician, etc.). Inventory management and guided preparation of antigen vial holders, allergy testing kits, and patient immunotherapy vial sets are key components of the systems and methods of the present disclosure. Allergy testing and treatment computer system 100 is accessed by users 110 using electronic computing devices 130 (e.g., smart phone, tablet computer, laptop computer, desktop computer, and the like) over communication network 140. Scanner 180 is configured to communicate with electronic computing devices 130 and with allergy testing and treatment computer system 100. Scanner 180 provides computer reading ability and may be a handheld barcode scanner or even a camera device on a smartphone or tablet computer. Communication network 140 may be a local wired or wireless network, the Internet, or other type of network. For brevity, allergy testing and treatment computer system 100 will be referred to as "ATAT computer system".

ATAT computer system 100 comprises computer 143 comprising processor 145, input device 150, output device 155, memory 160, application 165 coupled with database 170, and network interface 175. While only one ATAT computer system 100 is illustrated, those with knowledge in the art will understand that ATAT computer system 100 may comprise more than one ATAT computer system and more than one of each of the components shown in FIG. 1.

According to an embodiment of the present disclosure, application 165 and associated databases 170 are installed and configured on computer 143 to carry out the features of ATAT computer system 100. One example of application 165 is a software and database platform named FileMaker Pro made available by FileMaker, Inc., of Santa Clara, California. Electronic computing devices 130 are configured to communicate with ATAT computer system 100 by installing a corresponding application on each of electronic computing devices 130. ATAT computer system 100 may also be configured to communicate with electronic computing devices 130 using a web browser. Those with knowledge in the art will understand that other networking configurations may suffice. ATAT computer system 100 is configured to communicate with a plurality of electronic computing devices 130 at the same time.

ATAT computer system 100 is used by a clinic (also referred to herein as a medical practice or healthcare facility). ATAT computer system 100 may be associated with one clinic at a single location or with multiple clinics at more than one location (with related or unrelated ownership). ATAT computer system 100 may be physically located at a clinic or hosted elsewhere and accessed using an Internet web browser.

FIG. 2 shows a schematic diagram of various modules of an allergy testing and treatment system of the present disclosure. The various modules work together to provide a comprehensive system for the testing and treatment of allergies. Using ATAT computer system 100, a person with very little training or experience will be proficient, accurate, and safe in providing allergy testing and treatment. Practitioners that do not normally provide allergy- related medical services will be able to do so confidently using ATAT computer system 100. Experienced practitioners will gain more confidence in providing allergy services using ATAT computer system 100. As will be discussed further herein, one of the main modules of ATAT computer system 100 is inventory control module 205. Inventory control module 205 assists in ensuring that a proper inventory item is being used. Inventory control module 205 also provides creation of inventory profiles tracking of inventory so that inventory purchase decisions may be made. Inventory bar code generator 210 provides generating unique identifiers that will be associated with inventory items. ATAT computer system 100 permits printing of the generated unique identifies. The barcodes are affixed to inventory. The barcodes are used to verify that the proper item (e.g., an antigen vial) is used. Inventory purchasing 240 assists in determining when inventory must be ordered and further assists in creating purchase orders. ATAT computer system 100 allows users to test for allergies using allergy testing module 215. ATAT computer system 100 allows users to provide immunotherapy treatment for patients using immunotherapy module 220. In providing allergy testing and immunotherapy, use of proper inventory is vital. Thus, inventory control module 205 communicates with allergy testing module 215 and immunotherapy module 220. As will be discussed further herein, allergy testing module 215 and immunotherapy module 220 provide verifications to users that they are using the proper inventory item. Penicillin allergy testing module 260 assists in administering penicillin testing. A patient tracking module 230 allows a clinic to receive patient intake information, prescreen a patient, receive informed consent for treatment, track allergy testing results, track immunotherapy progress, etc. Billing module 225 assists users in billing for allergy testing and treatment events. An emergency response module 235 is provided in the event a patient suffers an adverse response when exposed to an antigen/allergen. Timekeeping module 245, messaging module 250, and certification module 255 are also noted in FIG. 2.

FIG. 3 shows a flowchart illustrating a general process of using an allergy testing and treatment system of the present disclosure. ATAT computer system 100 is setup by installing and configuring the computer systems and devices shown and described in FIG. 1. Once ATAT computer system 100 and the associated devices are configured, the clinic information and its location are input and stored in ATAT computer system 100 (step 305). In step 310, clinic user profiles are input and stored in ATAT computer system 100. A given clinic will have at least one physician and at least one staff member (e.g., a nurse, nurse practitioner, allergy technician, inventory manager, patient manager, etc.) who will be granted access to the system. Identifying information (e.g., name, address, etc.), login credentials (username and password) and role (e.g., physician, nurse, etc.) are input for users. The users are assigned to one or more clinics so they can access the inventory associated with their assigned clinics. Next, inventory profiles are input and stored in step 315 for a given clinic at a given location. Inventory comprises the allergy treatment and testing supplies (antigens, antigen vial holders, glove, syringes, etc.) consumed as patients are tested and treated. Inventory is obtained from various medical supply companies. For an existing clinic, inventory on hand is input and new inventory may be ordered and managed using the purchase order system described herein. For a new clinic, the purchase order system may be used to order starting clinic inventory. To store inventory, ATAT computer system 100 is requested to generate unique identifiers in a computer-readable form that are printed and affixed inventory items and linked with a particular clinic location (i.e., a storage location within a clinic). According to one embodiment of the present disclosure, the computer- readable unique identifiers are manifested as barcodes. It is an essential feature that a unique identifier be assigned to each inventory item. It is also an essential feature that a given inventory item be associated with a location where the inventory item will be stored. According to an embodiment of the present disclosure, a unique barcode is generated (step 312), printed, and then physically affixed to an inventory item. In an embodiment of the present disclosure, a plurality of barcodes may be generated and printed onto a label sheet. Each label is then physically applied to an inventory item. The printed barcode is computer-readable via scanning using scanner 180 connected with or in communication with electronic computing devices 130. Electronic computing devices 130 are configured to input the scanned barcode information into the inventory profile of ATAT computer system 100 so that the barcode information is linked to an inventory item (step 314). A location where the inventory item will be physically stored must also be input or selected and linked in step 314. If the inventory item is an antigen vial (step 315), the antigen vial is further assigned to a position in an antigen vial holder in step 317. This position information is stored in the antigen vial profile. An antigen vial holder is a rack (see FIG. 10, FIG. 34) used to organize and store antigen vials. The assigned position of an antigen vial in the antigen vial holder is needed (in combination with the barcode feature described herein) to later verify that the intended antigen vial being used is the correct antigen vial that should be used. As will be discussed further herein, when antigen vial inventory is used, scanner 180 is used to scan the barcode on the antigen vial to ensure that the proper vial is in use. If the proper vial is not in use, the user is alerted and cannot proceed with the guided testing or treatment.

Patients profiles are created and associated with a clinic in step 320. A patient profile may be created when a patient comes into a clinic for allergy testing. After the patient profile is created, allergy screening (step 325), allergy testing (step 330), or immunotherapy (step 335) may be administered. As testing and immunotherapy occurs, inventory is being consumed or proceeding to expiration in the case of antigens. Once the system determines that a given item of inventory has been consumed (e.g., concentration has fallen below a threshold) or is expiring in step 340, an alert may be generated and purchase order may be established for approval (step 345) and, once approved, sent to a vendor or supplier to be fulfilled. When ordered inventory arrives, a barcode must be applied to the new inventory item as previously explained above. If the inventory item has not been consumed or expired, the item may continue to be used (step 342).

FIG. 4 shows a personal dashboard or control panel of an allergy testing and treatment system of the present disclosure. Dashboard 405 is displayed on electronic computing devices 130 and displays buttons linked to the various modules of ATAT computer system 100. The modules are accessed by pressing the desired button using an input device such as a mouse, keyboard, or touch screen.

Email button 410 links a user to an email message display of messaging module 250 where a user may view and respond to clinic notifications and perform email or clinic messaging tasks. Time sheets button 415 links a user to a timekeeping interface of timekeeping module 245 where a user can input timekeeping data which interfaces with a payroll software system. The time sheet interface may also allow a user to authenticate him or herself by taking a self- photograph and interfacing with a GPS tracker to confirm identity and location. Exam button 420 allows users to access websites, such as the Health Insurance Portability and Accountability Act Exams website, for purposes such as compliance or certification as part of certification module 255. User guide button 425 displays the user guide or manual of ATAT computer system 100. The active/archived notifications tab section 430 displays reminders of tasks that should happen on specific dates (e.g., ordering inventory reminders, incremental billing reminders) or an archive of reminders. If notifications are archived, they may be viewed by pressing an archive tab on active/archived notifications tab section 430. Clinic notifications 435 displays list of tasks for a given clinic. For example, in the case of incremental billing for mixing immunotherapy vials (as will be discussed further herein), an automatic notification is generated for follow-up by any user associated with the clinic doing billing tasks. Clinic notifications will not always be displayed, so clinic notifications 435 is shown in dashed lines in FIG. 4. Active/archived notifications tab section 430 and clinic notifications 435 are components of messaging module 250.

Dashboard 405 also comprises buttons to link to allergy test kit preparation screens. FIG. 4 shows environment test kit button 440, adult food test kit button 445, and pediatric food test kit button 450 which are part of allergy testing module 215. When a test kit is prepared, ATAT computer system 100 provides computer-responsive and computer guided instructions so that antigen from antigen vials in antigen vial holders is properly placed into the appropriate reservoirs of allergy testing kits. Because allergic reactions can be severe enough to result in death, it is vital to ensure that the proper items are given to a patient. Allergy test kit assembly is described further herein.

The print sheets of barcodes button 455 initiates generation of barcodes that will be printed. Search for barcode input field 460 allows a user to search for a barcode number within the system by scanning a barcode, typing input, and/or other forms of input. Activity report button 465 allows users to see system activity, for example, by date range. Patient tracking button 470 allows users to see activity for a specific patient. Patient list button 473 displays a list of patients associated with or who have been tested and treated at a given clinic.

The inventory control button 475 links a user to an inventory listing and purchase order assembly screen of inventory control module 205 and inventory purchasing module 240. Dashboard 405 also comprises buttons that link a user to patient information screens for environment allergies 480, food allergies 485|, and penicillin allergy 490. The patient information screens display patient profile information (e.g., name, date of birth, identification, insurance carrier, etc.). The various patient testing and treatment functions are navigated to from these patient information screens.

Inventory Control

FIG. 5 shows an inventory list view screen display of an allergy testing and treatment system of the present disclosure. Inventory in the present disclosure comprises antigens stored in vials and other supplies that will be tracked by the system for ordering (gloves, syringes, allergy testing kits, computers, measuring tools (see FIG. 17), etc.). The system handles antigens differently from non-antigens. The inventory list view of FIG. 5 displays a purchase order number 505, the clinic 510 where the inventory is stored, the item 515, the quantity 520 of item in stock, the lot number 525, the date the inventory item was ordered 530, and the date it was received 535. Even though only one item is shown listed in FIG. 5, it should be understood that a clinic will have many inventory items. When a given inventory item is selected, detailed information is displayed for the selected inventory items as shown in FIG. 6. FIG. 5 also shows menu button 540 (returns a user to dashboard 405), purchasing button 545 (navigates to purchase order screens), and search button 550 (to assist inventory searching).

For non-antigen and supply tracking, the following details are displayed: purchase order number 605, date received 610, the item 615 (the vendor's name for the item), the product name 620 (typically containing a reference to the volume of the item), a description 625, the quantity on hand 630, the type 635 (i.e., the category of the item), the unit 640 (single item/case), reorder threshold 645, the location in the clinic 650, the item barcode 655 (a computer readable unique identifier), the clinic information 660, and the vendor information 665. A list of data input reminders 670 is also included: add quantity 675, add clinic location 680, and add barcode 685 reminders will be displayed as checkboxes. As the corresponding information is input, these checkboxes preferably will be ticked signifying the data has been entered. Data input reminders 670 alert the user to vital data that should not be omitted. Location in clinic 650 informs a user where the inventory item is stored at the clinic (i.e., a particular location in a clinic). For example, an item may be stored in a particular refrigerator. Inventory items navigation buttons may be provided. A search button may also be provided where a user can search for a particular item.

FIG.7 shows an inventory detail view screen display for an antigen inventory item. The same tracking information described with respect to FIG. 6 is displayed on the the antigen details screen except for unit and reorder threshold. The word allergen may also be used to refer to an antigen. The information displayed in FIG.7 is the information stored in an antigen vial profile of ATAT computer system 100. When an antigen item is received at a clinic and the information input into the display of FIG.7, such input creates an antigen vial profile. For antigen vial tracking, the following additional fields are displayed: lot number 705, expiration date 710, status 715 (open or sealed), destruction date 720, and estimated ml 723 (volume). For antigen items whose product name or item information lists the volume, this information is parsed by ATAT computer system 100 and automatically loaded into estimated ml 723. For example, an item may have a product name that includes "5 ml" in the product name. In this example, the value 5 ml will be input into estimated ml 723. with The value in estimated ml 723 is automatically updated as antigen is used. The added reminders are "add lot number" 725, "add expiration date" 730, and "add status" 735. When an antigen vial is open, open vial alert 740 is displayed. When an antigen vial is opened, status 715 is set to "open". When the antigen vial is destroyed, status 715 is set to "sealed".

The "choose antigen" button 745 is used to indicate the purpose for which the antigen vial will be used and to assign a position in an antigen vial holder that will be stored in an antigen vial profile. A user will indicate the purpose of the antigen vial: allergy testing or bulk antigen for compounding immunotherapy vials. If the antigen vial is used for allergy testing, the user will specify the type of allergy testing. According to an embodiment of the present disclosure, the allergy testing types are environmental allergies, adult food allergies, and pediatric food allergies. Other allergy testing types may be available. Antigen vials are stored in antigen vial holders (example antigen vial holders are shown in and described with respect to FIG. 10 and FIG. 34). Allergy testing involves moving amounts of antigen from antigen vials stored in antigen vial holders into allergy testing kits and then using the allergy testing kit to apply antigen to the skin. One example of an allergy testing kit is the ComfortTen Multiple Skin Test System for Puncture Skin Testing made available by HollisterStier Allergy of Spokane, Washington. Bulk antigen vials are also stored in bulk antigen vial holders. Compounding immunotherapy vials involves moving amounts of antigen from a bulk antigen vial into vials for a specific patient. An antigen vial must be assigned to a position in an antigen vial holder and the position stored in an antigen vial profile for verification as described later herein to occur. To assign the position, a listing of antigen names is displayed with a radio button next to each antigen name. The user will select the radio button of the antigen name from the listing that corresponds to the antigen vial they wish to position in an antigen vial holder. ATAT computer system 100 is configured to assign a given antigen type, depending on the designated purpose, to a particular position in a particular antigen vial holder. For example, cat hair antigen may have a configured position of well number 18 in an environmental allergy testing antigen vial holder when designated for environmental allergy testing. Cat hair may also have a configured position of well number 8 in a bulk antigen vial holder when designated as bulk antigen for compounding immunotherapy vials. Each time a cat hair antigen vial is made active (status set to "open") for environmental allergy testing and the cat hair radio button is selected, the corresponding cat hair antigen vial profile is assigned to well number 18 in an environmental allergy testing antigen vial holder. And, each time a cat hair antigen vial is made active for bulk antigen for compounding immunotherapy vials and the cat hair radio button is selected, the corresponding cat hair antigen vial profile is assigned to well number 8 in a bulk antigen vial holder. In this example, the cat hair antigen for environmental allergy testing and the cat hair antigen for bulk antigen for compounding immunotherapy vials will have different antigen vial profiles with different assigned positions (and different barcodes). As noted below, only one antigen vial per designation (testing or immunotherapy) should be active at a particular location. The position assignment process is completed for each antigen vial profile when making an antigen vial active (setting the status 715 to "open"). Each antigen type has a configured position. The configured position may be changed if needed. After assigning a position in an antigen vial profile, the antigen vial must be placed in the corresponding position (i.e., well) in the proper antigen vial holder. The position must be maintained as the antigen vial is used. A verification system using the stored positon in the antigen vial profile, in combination with the barcode information, as further described below, will prevent use of the wrong antigen. A graphical user interface with a display of antigen vial holder positions may also be used to assist assigning the antigen vial profile to a position in the antigen vial holder. A graphical user interface of such a display may also be used to instruct a user in which well to place an antigen vial. FIG. 8 shows a flowchart illustrating an antigen tracking process of the present disclosure. Antigen vial tracking process begins with input of a new antigen inventory item into an antigen inventory detail screen (see FIG. 7). ATAT computer system 100 receives input of the antigen details shown in FIG. 7 in step 800. The antigen vial should be properly stored at the clinic while not in use (e.g., refrigerated in a known location). When an antigen vial is ready for use for the first time, it is removed from storage, opened, and used (e.g., used for immunotherapy). In step 805, the user sets the antigen status to "open" (see status 715 of FIG. 7). In step 810, the system will receive input relating to the choose antigen field where the user will note the purpose for the antigen vial (allergy testing type (environmental, adult food, pediatric food) or bulk antigen). In step 820, the position of an antigen vial in an antigen vial holder used for allergy testing or in an antigen vial holder used for compounding patient immunotherapy vials is assigned to the antigen vial profile. If a second antigen vial profile is assigned to the same position as an open antigen vial, an alert will display (open vial alert 740). Only one antigen vial should be open at at a time for a given location. As antigen is used in step 825, the estimated ml field is updated in step 830 based on decreasing the current estimated ml amount by the amount used to build allergy test kits and compound patient immunotherapy vials (these amounts are known as the allergy test kit preparation and compounding patient immunotherapy vial instructions, including amounts of antigen to use, are stored in and displayed by ATAT computer system 100). Eventually, the antigen will either become depleted or will expire. The system determines whether the antigen should be retired in step 835. The system should be configured to generate a reminder to reorder antigen when the estimated ml of an antigen vial profile is equal to or lower than a set value or when the expiration date is approaching (i.e., setting a value for the number of days before expiration to reorder). A reorder notification alert is generated to prompt a user to create a purchase order in step 840. When the open antigen vial is retired, status 715 should be set to "sealed" in step 845. A destruction date is input into destruction date 720 in step 850. Once an antigen has been retired, a "destroyed" notice is displayed in step 855.

Patient Setup and Screening

FIG. 9 shows a flowchart illustrating a patient intake and screening process of the present disclosure. Prior to giving a patient allergy testing and treatment services, a patient profile is created in step 905. The patient' s name and date of birth are input and received to be stored by ATAT computer system 100. A patient identification number is generated which is a unique identifier for each patient. The medical practice or clinic that the patient is being seen at must be selected and is assigned to the patient in step 910. The patient's insurance carrier must also be input and is assigned to the patient in step 915. If a patient is paying out-of-pocket (without insurance), such a notation is made in place of the insurance carrier.

After creating the patient profile, the patient must give informed consent where it is documented in step 920 and provide a medical history documented in step 930. A guided informed consent form is generated and filled out with the patient present. The patient signifies informed consent by inputting his or her signature. The signature is captured digitally using a tablet computer or a pen type input device in step 925. Next, a medical history input form is displayed and the patient will answer various questions related to his or her medical history. Part of the medical history is an allergy test prescreen question form where questions must be answered to determine whether the patient might have an adverse reaction to allergy testing or treatment. According to an embodiment of the present disclosure, the following allergy test prescreen questions are asked: (1) Are you on any blood pressure medication? (2) Are you on any heart medication? (3) Have you ever had a stroke? (4) Have you ever been diagnosed with, or have a history of cardiovascular disease? (5) Have you ever had a severe anaphylactic reaction (severe allergic reaction) that required medical attention? (6) Are you a moderate/severe asthmatic? (7) Within the past year have you had an allergy scratch test? (8) Are you pregnant? Different or additional questions may be used.

ATAT computer system 100 stores the medical history and answers to the allergy test prescreen questions in step 935 and determines if a risk is present in step 940. Allergy testing options are not made available to the user in step 945 if the allergy test prescreen questions indicate risk for allergy testing. According to an embodiment of the present disclosure, if any of the question listed above are answered "yes", the ATAT computer system 100 does not let the user proceed. Other questions, as well as other tolerances to the answers, may be used. A practitioner (e.g., physician, nurse practitioner, etc.) may proceed past step 945 by inputting an override in step 950. The input override may be a signature or some other credential (e.g., signature and a password). If an override is present, the user may proceed with allergy testing of the patient in step 955. If there is no risk indicated by the allergy prescreen question answers (step 940), the user may proceed to test in step 955.

As the medical history and allergy test prescreen questions are answered, the system determines whether or not there is any indication that the patient may be asthmatic or prone to an asthma attack in step 960. For example, if the allergy prescreen test question "Are you a moderate/severe asthmatic?" is answered "yes", ATAT computer system 100 will display the asthma alert. ATAT computer system 100 may be configured to display an asthma alert based on the answers to other questions or from a combination of answers. An alert is displayed to indicate potential for asthma during treatment in step 965 (or to assist asthma treatment). An option is provided to display an asthma alert even if the medical history and allergy test prescreen questions do not indicate that the patient is asthmatic. If the system receives an asthma indication input in step 970, ATAT computer system 100 proceeds to display the asthma alert (step 965).

If the person being tested or treated is an existing patient, identifying information may be input for ATAT computer system 100 to find an existing patient's profile and load the information into the patient display screen in step 907. If the existing patient has already had allergy testing (testing completed step 975), ATAT computer system 100 will permit access to the immunotherapy features (e.g., compounding patient vials, recording immunotherapy progress, etc.)

Once a patient profile is created and consent is given and the patient is screened, allergy testing may commence. From dashboard 405, a user selects the appropriate button to display the allergy testing screens. For example, for environmental allergy testing, the user will select environment allergies 480.

FIG. 10 shows a perspective view of an antigen vial holder used to load an allergy testing kit. As previously stated, an example allergy testing kit is the ComfortTen Multiple Skin Test System for Puncture Skin Testing (not shown). Allergy testing antigen vial holder 1000 shown in FIG. 10 is an example of an environmental allergy testing antigen vial holder. The allergy testing antigen vial holder of FIG. 10 shows fifty wells 1005. The fifty wells are grouped into five "panels" identified by a panel group indicator (Panel Group Indicator A 1010, Panel Group Indicator B 1015, Panel Group Indicator C 1020, Panel Group Indicator D 1025, and Panel Group Indicator E 1030) and one Panel Group Indicator Mix 1035. For environmental testing, the panel group indicators organize the wells 1005 as follows: Panel A: Molds, Panel B: Animals, Panel C: Pollens, Panel D: Pollens, Panel E: Pollens, and Panel Mix: Mix (i.e., a mix of antigens). Each panel has ten wells 1005 arranged in two columns and five rows, except for the mix column which has one column with five rows of wells 1005. Other arrangements may suffice. The arrangement and grouping of wells on the antigen vial holder should match the arrangement of the allergy testing kit and of the allergy scoring screens later described. The allergy testing antigen vial holder is colored 1040. The allergy testing antigen vial holders for other allergy types (e.g., adult food allergy and pediatric food allergy) are both different colors so that they are visually distinguishable. The panel grouping indicators are also color coded as shown in FIG. 10. For illustration purposes, different fill patterns are used to indicate color of the antigen vial holder and panel grouping indicators. Each panel grouping indicator has a different color when compared to the other panels. According to an embodiment of the present disclosure, the following colors are used for the following panel group indicators of an environmental allergy testing antigen vial holder: Panel A: light blue; Panel B: orange; Panel C: yellow, Panel D: purple, and Panel E: green; and the Mix: gray. Other colors may be used.

To load an allergy testing kit from allergy testing antigen vial holder 1000, allergen must be added from the antigen vials in a systematic manner to avoid placing the wrong antigen in the wrong reservoir of the allergy testing kit. Setting up the allergy testing kits is tedious and error prone. The verification process described below eliminates error.

FIG. 11 shows a screen display illustrating a virtual allergy testing antigen vial holder corresponding to the allergy testing antigen vial holder of FIG. 10. The virtual allergy testing antigen vial holder is displayed to assist loading antigen into reservoirs of an allergy testing kit. Virtual allergy testing antigen vial holder 1100 mimics the appearance, color, and panel organization of allergy testing antigen vial holder 1000. Virtual allergy testing antigen vial holder of FIG. 11 shows fifty virtual wells 1105 that match the arrangement of wells of allergy testing antigen vial holder 1000. The virtual wells are grouped into five virtual "panels" using virtual panel group indicators (Virtual Panel Group Indicator A 1110, Virtual Panel Group Indicator B 1115, Virtual Panel Group Indicator C 1120, Virtual Panel Group Indicator D 1125, Virtual Panel Group Indicator E 1130, and Virtual Panel Group Indicator Mix 1135). The antigens in the panels of the virtual antigen vial holder match the antigens of the actual antigen vial holder. Virtual antigen vial holder 1100 has ten virtual wells 1105 arranged in two columns and five rows and mix column having one column with five rows of virtual wells 1105 (matching the corresponding well arrangement and panel groupings as antigen vial holder 1000). Virtual wells 1105 display the antigen name (not shown in FIG. 11) that should be stored in the corresponding well 1005 of antigen vial holder 1000. The wells may also be numbered as shown. The virtual allergy testing antigen vial holder is color 1140. Color 1140 of virtual allergy testing antigen vial holder 1000 matches color 1040 of allergy testing antigen vial holder 1000. The virtual panels of virtual allergy testing antigen vial holder 1100 are also color coded and match the colors of the panel grouping indicators of allergy testing antigen vial holder 1000. Clinic selection field 1145 is displayed and used to input the clinic where an allergy testing kit will be assembled from allergy testing antigen vial holder 1000. Dashboard button 1150 takes the user back to dashboard 405. Reset button 1155 resets the screen displaying virtual antigen vial holder 1100 to restart the loading process described below (if needed).

FIG. 12 shows a flowchart illustrating an allergy testing kit loading process. Initially, a test kit is selected and ATAT computer system 100 receives input of the selected test kit in step 1205. According to an embodiment of the present disclosure, the user selects the environment test kit, adult food test kit, or pediatric food test kit by pressing environment test kit button 440, adult food test kit button 445, or pediatric food test kit button 450. It is noted the system of the present disclosure is not limited to environment or food allergy testing. A corresponding virtual allergy testing antigen vial holder (such as the one illustrated in FIG. 1 1), where the layout and color matches the actual antigen vial holder, is displayed responsive to the input (step 1210). The user should perform a visual inspection to ensure they have selected the proper antigen vial holder for loading by matching the actual antigen vial holder color to the virtual antigen vial holder color (e.g., matching color 1040 to color 1140). Next, the clinic must be selected and the selection communicated to ATAT computer system 100 where it is received in step 1215. The clinic is selected using with clinic selection field 1145. Next, a panel from the virtual allergy testing antigen vial holder is selected by selecting or tapping one of the virtual panel grouping indicators (FIG. 1 1) and ATAT computer system 100 receives input of the selected panel grouping in step 1225. A close-up version of the selected panel is displayed in step 1230 in response to the selection in step 1225. A virtual allergy test kit is also displayed.

FIG. 13 shows an illustration of an allergy testing kit loading guide displayed over the screen display of FIG. 1 1. In FIG. 13, the user has selected to load an allergy test kit with Panel B via selection of virtual panel grouping indicator 1115. In response, Panel B wells are shown. Next to the wells, an interactive virtual allergy test kit 1305 is displayed. Virtual allergy test kit 1305 matches the reservoir organization and arrangement of the allergy test kit used. The arrangement of wells on virtual antigen vial holder 1100 may be modified to match the reservoir arrangement of the allergy testing kit used. Further, the actual antigen vial holder may be modified as well so that there is visual correspondence between the actual antigen vial holder, the virtual antigen vial holder, the panel organization, and the allergy testing kits.

FIG. 14 shows a close-up view of a portion of FIG. 13. FIG. 14 is a close-up view of the dotted line box 1310 in FIG. 13. Well 1405 is one of virtual wells 1105 of the selected virtual panel grouping indicator 1115. Well 1405 in FIG. 14 is labeled "cat hair". Reservoir 1415 from the virtual allergy test kit is shown as well. Label 1410 displaying the corresponding antigen name is shown as well. Pull checkbox 1420 (used to indicate that a user has selected an antigen vial from antigen vial holder 1000 to load into the allergy test kit) and barcode field 1425 are initially displayed.

FIG. 15 shows the close up of FIG. 14 over a period of time illustrating screen changes occurring as antigen is loaded into an allergy testing kit reservoir. With reference to FIG. 12, in step 1235, input is received that a particular item on the allergy testing antigen vial holder has been selected to be loaded into a test kit. The user will select the reservoir of the virtual allergy test kit antigen vial they wish to load by clicking pull checkbox 1420. When doing so, the well on the virtual antigen vial holder that should be used will undergo a color change to differentiate it from the other vials in step 1240. In FIG. 15, well 1405 changes color as shown by well 1405A. The actual corresponding antigen vial 1505 is removed from the antigen vial holder, and barcode 1510 is scanned (computer read) with scanner 180 (see FIG. 1). After scanning barcode 1510, the barcode number is input and received (step 1245) and displayed in barcode field 1425 (step 1250). As previously described, each antigen vial has an assigned position in an antigen vial holder that is stored in an antigen vial profile. In step 1255, ATAT computer system 100 determines if scanned and input barcode 1510A matches the barcode from the antigen vial profile assigned to the position of the antigen vial scanned from the antigen vial holder. If there is no match, a warning is displayed in step 1260. No match indicates that the wrong antigen vial has been selected (or the wrong antigen vial is in the wrong position) and the user needs to troubleshoot the problem. If scanned barcode 1510 matches the barcode assigned in the antigen vial profile to the corresponding position of the antigen vial in the antigen vial holder, virtual well 1405 changes color again as shown by well 1405B. The user can proceed to fill the allergy test kit reservoir with a concentration per the allergy test kit instructions. Place checkbox 1515 is displayed as shown in FIG. 15. Once the test kit reservoir is filled, the user will indicate that the test kit reservoir has been filled by clicking place checkbox 1515. ATAT computer system 100 receives this action as input that the inventory item has been added to the test kit reservoir in step 1270. The color of virtual well 1405B reverts back to the original color. Antigen vial 1505 may now be returned to the proper position in antigen vial holder. After filling the allergy test kit reservoir with antigen, the estimated concentration (estimated ml 723) is updated in step 1275. The volume of antigen to add to each reservoir in allergy test kit setup is stored by ATAT computer system 100. The process is repeated until all allergy test kit reservoirs have been loaded (step 1280). Once loaded, allergy testing may commence (step 1285). A log of the allergy test kit loading may be stored as well.

The process described above for loading allergy testing kits may be similarly done with other antigen types including, but not limited to, adult food allergies and pediatric food allergies. According to one embodiment of the present disclosure, the antigen vial holders for environmental antigens are green, the antigen vial holders for adult food allergies are yellow, and the antigen vial holders for pediatric food allergies are pink. The corresponding virtual antigen vial holders are the same color as described above. Other colors may be chosen so long as the color of the actual antigen vial holder matches the color of the virtual antigen vial holder.

Additionally, different number of reservoirs and panels may be employed for various antigen vial holders. For example, the adult food allergy testing has 6 panels with 60 reservoirs. The panel grouping indicators colors are colored as follows: Panel A: fuscia; Panel B: light blue; Panel C: yellow; Panel D: purple; Panel E: rose; and Panel F: Orange. According to an embodiment of the present disclosure, the pediatric food antigen vial holder comprises three panels with 30 reservoirs. The panel grouping indicator colors for the pediatric food allergy antigen vial holder are as follows: Panel A: blue; Panel B: green; Panel C: purple. The antigen vial holders may be labeled with the panel grouping indicators using adhesive backed printed sheets.

FIG. 16 shows an illustration of an allergy testing scoring screen and a close-up view of a portion of the allergy testing scoring screen. Allergy testing scoring screen 1600 lists antigens tested arranged in panels (corresponding to the panels of the allergy testing antigen vial holders). FIG. 16 shows Panel A results input form 1605, Panel B results input form 1610, Panel C results input form 1615, Panel D results input form 1620, Panel E results input form 1625, and Mix results input form 1630. Each panel has an associated color (e.g., a background color) and the color matches the color of the panel grouping indicator on the actual allergy testing antigen vial holder 1000 and virtual allergy testing antigen vial holder 1100. For example, color of Panel A results input form 1605 matches color of Panel Group Indicator A 1010 and color of Virtual Panel Group Indicator A 1110. The color matching ensures that the user is scoring the proper allergy test using visual color confirmation. Allergy testing is typically done by introducing the allergen into the skin of the patient by injection or scratching the surface of the skin. When an allergic reaction occurs, a wheal is visible on the skin. A wheal is a red, swollen, raised area of the skin. A tool, such as the one shown in FIG. 17, is used to measure the various wheals.

FIG. 17 shows a plan view of a tool used to measure and score patient reactions. Tool 1700 (an embodiment of an allergic response measuring tool) has one edge with notches of various lengths. According to an embodiment of the present disclosure, tool 1700 has the following notches with the following lengths: notch 1705, 50 millimeters; notch 1710, 25 millimeters; notch 1715, 13 millimeters; notch 1720, 1 1 millimeters; notch 1725, 9 millimeters; notch 1730, 7 millimeters; notch 1735, 5 millimeters; notch 1740, 3 millimeters.

In the body of tool 1700 are openings that indicate particular measurements. According to an embodiment of the present disclosure, tool 1700 has the following openings with the following diameters: opening 1745, 50 millimeters; opening 1750, 25 millimeters; opening 1755, 13 millimeters; opening 1760, 1 1 millimeters; opening 1765, 9 millimeters; opening 1770, 7 millimeters; opening 1775, 5 millimeters; opening 1780, 3 millimeters. According to an embodiment of the present disclosure, the lengths of the notches are aligned with diameters of the openings, as shown. Tool 1700 displays a legend indicating the length of the notches (e.g., 50mm shot reaction, 25 mm shot reaction, etc., as shown in FIG. 17) and of the openings (e.g., 50 mm reaction, 25 mm reaction, etc.). The legend may be color coded to indicate if a result may be negative or positive or the severity of a reaction. Tool 1700 may be constructed from a number of materials including paper, plastic, transparent plastic, etc. Tool 1700 is used to measure the wheals that appear on the skin for scoring. The openings or the notches may be used to measure the wheals. The legend assists a user to easily determine a measured value for scoring. Tool 1700 also contains penicillin allergy reaction ruler 1790. As noted in FIG. 17, each space corresponds to 1mm. Penicillin allergy reaction ruler 1790 is not limited to measuring penicillin allergy reactions.

Returning to FIG. 16, the wheals for each allergen are recorded (along with a positive and negative control) in the scoring sheet shown in FIG. 16. The bottom portion of FIG. 16 shows a close-up view of a portion of Panel C results input form 1615. Here the user may input the wheal measurement in the wheal column for the corresponding inventory item and indicate whether the test was positive or negative in the results column. A test is positive if the wheal measurement exceeds a certain amount. When all the tested inventory items are scored, the user taps results button 1635. A summary of the test results is generated by ATAT computer system 100. The test results should next be presented to a practitioner (licensed physician, nurse practitioner, etc.) for review and signature and submission to the ATAT computer system 100. Once signed and submitted to ATAT computer system 100, a test billing form is automatically generated and the testing results are logged in the patient tracking log. The results from the allergy testing are used to determine the antigens given to a patient for immunotherapy injections. A practitioner may review these results.

According to an embodiment of the present disclosure, the environment allergy testing tests the following items in the indicated panels: Panel A Molds: Cockroach Mix, Asper Niger, Alter Tenuis, Rhizo nig., Fusarium, Helm, Hormo Clad, Mucor, Pen Mix, and Trycho Mix; Panel B Animals: Positive Control, Negative Control, Mite DF, Mite DP, Guinea Pig, Horse Hair, Cattle Hair, Cat Hair, Dog Hair, and Feather Mix; Panel C Pollens: Pine, Oak, Mulberry, Mesquite, Hickory, Hackberry, Pecan Tree, Elm, Sycamore, and Walnut; Panel D Pollens: Box Elder Maple, White Ash, Cotton Wood, Lenscale Weed, Pigweed, Russian Thistle, Cocklebur, Dock Sorrel, Lambs Quarter, and Ragweed; Panel E Pollens: Marsh Elder, Plantain English, Sagebrush, Cedar Mountain, Cypress Bald, Fescue Meadow, Timothy Grass, Orchard Grass, Johnson Grass, and Bermuda Grass; Mixes: Mold Mix, Mite Mix, Tree Mix, Weed Mix, and Grass Mix.

According to an embodiment of the present disclosure, the adult food allergy testing tests the following items in the indicated panels: Panel A: Almond, Brazil Nut, Cashew, Hazelnut, Peanut, Pecan, Walnut, Egg White, Egg Whole, and Milk, Cow; Panel B: Positive Control, Negative Control, Apple, Banana, Cantaloupe, Grape, Orange, Peach, Strawberry, and Tomato; Panel C: Catfish, Clam, Codfish, Crab, Flounder, Shellfish Mix, Fish Mix, Lobster, Oyster, and Salmon; Panel D: Scallops, Shrimp, Tuna, Barley, Hops, Whole Oat, Rice, Rye, Soybean, and Sesame; Panel E: Saccar Homyce, Whole Wheat, Buckwheat, Cacoa Choco, Cinnamon, Coconut, Garlic, Vanilla, Coffee, and Turkey; Panel F: Green Bean, Broccoli, Carrot, Corn, Green Pea, Green Pepper, Potato, Beef, Chicken, and Pork.

According to an embodiment of the present disclosure, the pediatric food allergy testing tests the following items in the indicated panels: Panel A: Almond, Cashew, Peanut, Pecan, Coconut, Sesame, Cacao Choco, Egg White, Egg Whole, and Milk; Panel B: Positive Control, Negative Control, Apple, Banana, Orange, Strawberry, Tomato, Carrot, Corn, and Garlic; Panel C: Shellfish Mix, Fish Mix, Whole Oat, Rice, Soybean, Whole Wheat, Beef, Chicken, Pork, and Turkey.

Penicillin Testing

ATAT computer system 100 assist with penicillin allergy testing. To commence penicillin allergy testing, a user selects penicillin allergy button 490 from dashboard 405. The user will either search for an existing patient or create a patient profile as described above with respect to FIG. 9. There are two types of penicillin tests that will be described: a penicillin skin prick test ("SPT") and a penicillin intradermal ("ID") test.

FIG. 18 shows a penicillin allergy testing screen layout of the present disclosure. More particularly, FIG. 18 shows the general layout of penicillin testing screen 1800 that will be used for both penicillin skin prick testing and penicillin intradermal testing according to an embodiment of the present disclosure. Penicillin testing screen 1800 displays virtual penicillin sticker 1805 and tabbed section 1810. The tabs of tabbed section 1810 are selectable. According to one embodiment of the present disclosure, three tabs are present, as shown: checklist 1815, tasks 1820, and legend 1825. Penicillin testing screen 1800 is accessed after loading a patient's profile and actuating a penicillin testing button (not shown). Patient data is automatically loaded into the appropriate fields of penicillin testing screen 1800 (patient name, patient date of birth, patient ID, medical practice, and practitioner). A penicillin skin prick test is performed first.

FIG. 19 shows a flowchart illustrating a penicillin allergy skin prick testing process of the present disclosure. As shown in FIG. 18, penicillin testing screen 1800 displays a virtual penicillin skin prick test sticker 2400 (see FIG. 24) in step 1905. A test date and a test time are input into penicillin testing screen 1800 (test date field 1830 and testing time field 1835) and received in step 1910. A penicillin skin prick test checklist is displayed in tabbed section 1810 in step 1915 (the contents of the penicillin skin prick test checklist are show in FIG. 24 with checklist tab 1815 selected). In step 1920, ATAT computer system 100 instructs the user to place penicillin skin prick test sticker 2100 (see FIG. 21) on the patient's inside forearm. After properly placing the sticker on the patient's arm, the corresponding checklist item (sticker placement checkbox 2505, see FIG. 25) is toggled to indicate that it has been completed, and ATAT computer system 100 receives input that the skin prick test sticker is in place in step 1925. An initial timer is displayed in step 1930. The user applies a histamine control and a negative control as directed to the skin on the patient's arm within the appropriate openings (histamine opening 2105 and negative control opening 2110) of the skin prick test sticker 2100 in step 1932. The user actuates the initial timer in step 1934 by pressing the displayed timer button 2510 (see FIG. 25). ATAT computer system 100 receives this input and starts the timer countdown in step 1935. When the timer completes, a timer complete alert is actuated in step 1940. A chime or tone may be emitted from electronic computing device used by the user. Before the timer completes, the user has the option to restart the timer or end the timer early. The timer is turned off by the user tapping on the timer button so that ATAT computer system 100 receives a timer alert off input in step 1945. This action causes ATAT computer system 100 to stop the timer alert in step 1950. ATAT computer system 100 then displays measure and score indicator 2515 and field for histamine and the negative control in step 1955. Tool 1700 should be used to measure the results. The user then inputs the measured values into the histamine score field 2520 and negative control score field 2525. The values are received by ATAT computer system 100 in step 1960. ATAT computer system 100 determines if the histamine and negative control tests were valid based on the input scores in step 1965. If the tests are not valid, a problem needs to be resolved and the user should troubleshoot the possible causes in step 1970. If the test was valid, ATAT computer system 100 displays penicillin antigen testing timers 2530 in step 1975. A test will be valid if the wheal resulting from the histamine is four millimeters or greater. Four timers are shown in FIG. 25 and correspond to four penicillin antigens that will be tested.

FIG. 20 shows a flowchart continuing the penicillin allergy skin prick testing process of FIG. 19. According to an embodiment of the present disclosure, four types of penicillin tests are performed with the penicillin skin prick test: Pre-Pen, Pen-G, Pencilloate, and Penilloate. These four tests may be performed sequentially or simultaneously. In step 2005, the penicillin test is applied to the patient in the appropriate spaces of the sticker (Pre-Pen opening 2115, Pen-G opening 2120, Pencilloate opening 2125, and Penilloate opening 2130). The user starts the timer by pressing testing timer 2530 in the task tab of tabbed section 1810 and ATAT computer system 100 receives the start timer input in step 2010. After the timer completes in step 2015, ATAT computer system 100 displays the measure and score indicator and input fields (Pre-Pen score input field 2535, Pen-G score input field 2540, Pencilloate score input field 2545, and Penilloate score input field 2550) for the test timers started in step 2020. The user scores the tests and inputs the values into the corresponding fields and the system receives the input score values in step 2025. ATAT computer system 100 determines if there are any positive reactions in step 2030. A positive reaction is one in which the measured wheal is three millimeters or greater than the negative control score. It is noted that values determining whether a test if positive or negative may be modified based on current medical standards and practices; ATAT computer system 100 may be updated to reflect current medical standards and practices. If the patient has any positive reactions, no further testing should be done and the intradermal testing steps will not be made available by ATAT computer system 100 (step 2035). The user can log the testing activity to the patient' s record or chart and initiate billing. If there are no positive reactions, and there are negative reactions to all of the penicillin allergy tests, ATAT computer system 100 permits the user to proceed with further test penicillin allergy by enabling selection of a penicillin intradermal testing process in step 2040.

FIG. 21 shows an illustration of a penicillin skin prick testing sticker. Penicillin skin prick test sticker 2100 is an adhesive sticker be placed on a patient' s skin and discarded after use. Sticker 2100 has background color 2135. Each of the penicillin types tested are differentiated with different colors: Pre-Pen color 2140, Pen-G color 2145, Pencilloate color 2150, and Penilloate color 2155.

FIG. 22 shows an illustration of a penicillin intradermal testing sticker. Penicillin intradermal test sticker 2200 is similar to penicillin skin prick test sticker 2100. Sticker 2200 has negative control opening 2205, Pre-pen opening 2215, Pen G opening 2220, Pencilloate opening 2225, and Penilloate opening 2230. Each of the penicillin types tested are differentiated with different colors: Pre-Pen color 2240, Pen-G color 2245, Pencilloate color 2250, and Penilloate color 2255. Sticker 2200 has background color 2235. Amoxicillin testing instructions may also be displayed on penicillin intradermal test sticker 2200, as shown. Additional openings for penicillin antigens may be added if the testing is to be done in duplicate. Alternatively, two separate stickers may be used for duplicate testing.

As described above, penicillin skin prick test sticker 2100 and penicillin intradermal test sticker 2200 are applied to the patient prior to penicillin testing.

FIG. 23 shows a plan view illustrating a penicillin allergy testing kit rack. Penicillin allergy testing kit rack 2300 is used to hold the controls and penicillin antigens. Penicillin allergy testing kit rack 2300 has negative control (e.g., saline) vial well 2305 and positive control (e.g., histamine) vial well 2310, as shown. One side of penicillin testing kit rack 2300 has four vial wells (Pre-Pen vial well 2315, Pen-G vial well 2320, Pencilloate vial well 2325, and Penilloate vial well 2330) where vials are placed for the penicillin skin prick test. An additional four vials wells are present (Pre-Pen vial well 2335, Pen-G vial well 2340, Pencilloate vial well 2345, and Penilloate vial well 2350) where corresponding vials are placed for the intradermal test. Initially, the vials used for the skin prick test are placed in vial wells 2315, 2320, 2325, and 2330. These vial wells are labeled, as shown, and have a border color that matches the colors of the skin prick testing sticker 2100 and penicillin intradermal test sticker 2200, as shown. After the skin prick tests are completed, and if intradermal testing is warranted, the vials placed in vial wells 2315, 2320, 2325, and 2330 are moved to vial wells 2335, 2340, 2345, and 2350. The layout of penicillin allergy testing kit rack 2300 mimics the look of the penicillin skin prick test sticker 2100 and penicillin intradermal test sticker 2200.

FIG. 24 shows the penicillin allergy testing screen of FIG. 18 displaying a virtual penicillin allergy skin prick test sticker and penicillin allergy skin prick test checklist details. In FIG. 24, tabbed section 1810 displays the checklist for the penicillin allergy skin prick test and virtual spin prick test sticker, as shown.

FIG. 25 shows the tasks tab details of the penicillin allergy testing screen of FIG. 24. The details of FIG. 25 are discussed above.

FIG. 26 shows the penicillin allergy testing screen of FIG. 18 displaying a virtual penicillin allergy intradermal test sticker and penicillin intradermal test checklist details. If penicillin intradermal testing is permitted after penicillin skin prick testing, the penicillin allergy testing screen shows the screen layout of FIG. 18 with the details shown in FIG. 26. Tabbed section 1810 displays a checklist details of a penicillin allergy intradermal test as shown. Virtual penicillin allergy intradermal test sticker 2620 is displayed, as shown.

FIG. 27 shows the task tab details of the penicillin allergy testing screen of FIG. 26. The intradermal test tasks are displayed when the task tab 1820 is selected by the user.

FIG. 28 shows a display sequence for one row of task items of penicillin allergy intradermal testing of FIG. 27. More specifically, FIG. 28 shows one row of the task details of a penicillin allergy intradermal test as they are presented to a user as the user carries out the penicillin allergy intradermal test.

FIG. 29 shows a display sequence for the amoxicillin testing row task of the penicillin allergy intradermal testing of FIG. 27. More particularly, FIG. 29 shows task details of the amoxicillin test as they are presented to a user as the user carries out the amoxicillin test.

FIG. 30 shows a flowchart illustrating a penicillin allergy intradermal test process. If it is acceptable to conduct the intradermal test (see step 2040 of FIG. 20), an intradermal test button is made available. Upon receipt of input that the intradermal test should begin (step 3005), an intradermal test screen is displayed in step 3010. The penicillin allergy intradermal test screen layout is shown in FIG. 18; the details of the penicillin intradermal test screen are shown in FIGS. 26-29. Referring to FIG. 18, the upper portion of the penicillin intradermal test screen displays the patient information (name, date of birth, identification number, medical practice and practitioner); the details for a particular patient will be preloaded into the appropriate fields. The left side displays a virtual penicillin allergy intradermal test sticker 2620 (see FIG. 26) that has an identical arrangement and color scheme to an actual intradermal test sticker 2200 (see FIG. 22). ATAT computer system 100 receives an input date and time of test in step 3015. The initial part of the penicillin allergy intradermal test is to administer a negative control. The user will inject the negative control (placed in negative control opening 2205) to create a bleb (a small bubble or blister underneath the skin) within negative control opening 2205 (see FIG. 22) of penicillin intradermal test sticker 2200 and outline the bleb on the patient's skin with a writing implement. ATAT computer system 100 receives input to begin the negative control test in step 3020 when the user taps outline bleb button 2705 (see FIG. 27 and 28). ATAT computer system 100 starts a countdown timer in step 3025. When the timer countdown has completed (15 minutes), measure and score input field 2710 for the negative control is displayed 3030. The user inputs the results in step 3035. For the intradermal test, the user checks the patient's skin to assess whether the wheal generated from the negative control exceeds the bleb or is within the bleb. ATAT computer system 100 determines if further testing should proceed in step 3040 based on the input. If the patient's result exceeds the bleb, further testing is not permitted in step 3055. If the result is within the bleb, the negative control test is considered a "pass", and testing the penicillin antigens may commence. The penicillin antigen intradermal test is performed the same as described above with respect to the negative control: the user will inject the penicillin antigen into the patient forming a bleb and will outline the bleb on the skin. The four penicillin antigens injected intradermal are the same used in the skin prick test. These four tests may be administered simultaneously or sequentially one at a time. When ATAT computer system 100 receives input to begin the penicillin intradermal test in step 3050, a countdown timer starts in step 3055. When the timer stops, the system displays the measure and score fields in step 3057 for each test in which a timer was started. The user will then record whether or not the resulting wheal is within or exceeds the bleb outlined by the user (step 3058). ATAT computer system 100 determines if there are any positive results in step 3060. If any wheal exceeds the bleb, the ATAT computer system logs this as a positive result and further testing is not permitted (step 3064). If the patient had a negative reaction to all four penicillin antigens, the amoxicillin oral challenge test will be made available for the patient in step 3065.

FIG. 31 shows a flowchart illustrating an amoxicillin challenge portion of a penicillin allergy testing process of the present disclosure. The amoxicillin oral challenge involves administering amoxicillin orally to the patient. A first amoxicillin dose of 100 mg is given to the patient. The system receives input that the initial amoxicillin challenge test has begun in step 3105 by tapping timer 2715 (see FIG. 29). The system initiates a countdown timer 3110. In the amoxicillin test, the countdown timer is a thirty minutes. Once the timer has completed, an observe reaction field 2720 is displayed in step 3115. The user records whether the patient had a reaction in this field. If the patient had a reaction, a positive indication is input. If the patient did not have a reaction, a negative indication should be recorded. ATAT computer system 100 receives input of the test outcome in step 3120 and determines if further amoxicillin testing should be administered in step 3125. If a positive reaction is recorded, further testing is not permitted (stop 3130). If a negative reaction is recorded, the next amoxicillin test is displayed in step 3135. The user will tap the timer button associated with the second amoxicillin test to begin in step 3140. In this test 150 mg of amoxicillin is administered to the patient. A thirty-one- minute countdown is tracked by the system in step 3145. When the timer completes, the observe reaction field 2725 is displayed in step 3150 for user input. The user then indicates whether the patient had a reaction, and the system receives the input in step 3155.

The legend tab 1825 shown in FIG. 18 and other figures provides a legend for reading the results. Once testing has completed (or the system no longer permits testing), the user initiates a submission to a patient activity log. The system records the testing activity to the patient activity log. From this point billing may be initiated for the penicillin testing.

Immunotherapy

A goal of the various allergy testing processes described above is to determine which patients will benefit from immunotherapy. Immunotherapy is a medical therapy the goal of which is to lessen a person's symptoms to various allergies. Various increasing doses of antigen are given to a patient over time. Eventually, the patient should get to a maximum dose considered a maintenance dose. Improper mixing of allergen can have disastrous consequences for a patient, such as having an anaphylactic reaction or asthmatic reaction to an allergen. To administer immunotherapy, a set of patient vials must be prepared from bulk antigen vials. Many antigens may be placed into a single patient vial; thus, they must be mixed or titrated to the appropriate dose concentration. Over the course of a patient's immunotherapy treatment, immunotherapy response reactions are measured and the dose adjusted.

FIG. 33 shows a flowchart illustrating a patient immunotherapy vial mixing process continued form FIG. 32. FIG. 34 shows a perspective view of a bulk antigen vial holder. FIG. 35 shows a plan view of the bulk antigen vial holder of FIG. 34. FIG. 36 shows a perspective view of a patient vial mixing rack.

The user who will be mixing patient vials should have the following items: bulk antigen vial holder 3400 with bulk antigen vials 3405 (see FIG. 34), patient vial mixing tray 3600 and patient vials 3605. Patient vials are color coded with different colored tops (as shown) to correspond to various doses. According to one embodiment of the present disclosure, the patient vials are mixed to create lowest patient vial dose 3610, first intermediate patient vial dose 3615, second intermediate patient vial dose 3620, highest patient vial dose 3625, and maintenance dose 3630. In such an embodiment, highest patient vial dose 3625 and maintenance dose 3630 are the same dose, except that one patient vial is used for maintenance injections. According to an embodiment of the present disclosure, the vials have the following colored tops: lowest patient vial dose 3610: blue, first intermediate patient vial dose 3615: green, second intermediate patient vial dose 3620: yellow, highest patient vial dose 3625: red, and maintenance dose 3630: orange. Three columns of patient vials are shown in FIG. 36 corresponding to three types of immunotherapy treatment sets: first treatment set 3635, second treatment set 3640, and third treatment set 3645. According to an embodiment of the present disclosure, first treatment set 3635 contains mold antigens, second treatment set 3640 contains animal antigens, and third treatment set 3645 contains pollen antigens. Other antigen classes may be used as well. The patient vial sets may be inventory tracked as described herein. Patient vial mixing tray 3600 allows one to mix two sets of patient vial sets at the same time (i.e., the right side of patient vial mixing tray 3600 is shown empty, but may be used to mix a second set of patient vials for the same patient or another patient's vial set).

An electronic computing device 130 with scanner 180 in communication with ATAT computer system 100 is required to assist patient vial mixing, or compounding, according to an embodiment of the present disclosure. FIG. 36 shows patient vial mixing screen 3700 that is displayed on electronic computing device 130. Other various items used, for example, include syringes to withdraw antigen, gloves, etc.

Bulk antigen vial tray 3400 has bulk antigen vial holder color 3410, patient vial mixing tray 3600 has patient vial mixing tray color 3610, and patient vial mixing screen 3700 displays virtual bulk antigen vial tray 3745 and virtual patient vial mixing tray 3720 in all the same color. Having all the same color gives the user visual confirmation that they are using the proper bulk antigen mixing holder and patient vial mixing tray. According to an embodiment of the present disclosure, bulk antigen vial holder color 3410, patient vial mixing tray color 3600, virtual bulk antigen vial tray, and virtual patient vial mixing tray are all orange. Another color may be used; however, the items described above should be the same color.

Returning now to FIG. 32, a user will select a patient to mix immunotherapy vials and ATAT computer system 100 receives the selected patient input in step 3202. The patient will have already had allergy testing. The user will select the immunotherapy mixing module. ATAT computer system 100 will receive the input to start the patient vial mixing process in step 3204 and display patient vial mixing screen 3700 in step 3206. Patient vial mixing screen 3700 has mixing location field 3715 to receive input of the location where the patient vials are being mixed. The patient vial mixing location may not be the clinic where the patient is treating. For example, patient vial mixing may be done at a first location and then transported to a second location where immunotherapy will occur. Selection of the proper mixing location is vital to determine if the correct bulk antigen vial is being used as will be described below (due to the aforementioned position assignment of a bulk antigen vial in a bulk antigen vial holder). ATAT computer system 100 receives input of the mixing location in step 3208.

FIG. 37 shows a patient vial mixing screen. Patient vial mixing screen 3700 displays virtual patient vial mixing tray 3720. In FIG. 37, virtual patient vial mixing tray 3720 is shown on the left side of the screen. Virtual bulk antigen vial holder 3745 is shown on the right side of the screen. Three columns are displayed: mold column 3725 (corresponding to first treatment set 3635), animal column 3730 (corresponding to second treatment set 3640), and pollen column 3735 (corresponding to third treatment set 3645). The user will take antigen from the one or more vials on bulk antigen vial holder 3400 and place it into a patient vial with a diluent. To determine what antigen mix to place into patient vials, the following process is carried out. The following steps will be described with respect to mold column 3725; the same process applies to animal column 3730 and pollen column 3735. In step 3210, ATAT computer system receives input that mix checkbox 3740 has been toggled.

FIG. 38 shows an antigen verification screen 3800. Antigen verification screen 3800 is displayed in step 3212. Prior to permitting immunotherapy, ATAT computer system 100 has a patient log of allergy testing. ATAT computer system 100 permits addition of only those antigens with which immunotherapy might benefit a patient. In step 3214, ATAT computer system 100 only permits selection of antigens that the patient should receive based on the results of a patient's allergy testing. The antigens displayed for addition into a patient vial will be those that the patient had a positive test; however, various overrides may be present if a physician determines that certain antigens should not be added. As shown in FIG. 38, for example, pine mix 3805 and mulberry mix 3810 are highlighted and able to be selected. The other antigen types are disabled from selection. Antigen verification screen 3800 displays the volume of antigen to draw (draw volume 3815) from the bulk antigen vial in step 3216. Antigen verification screen 3800 also displays the volume of diluent (diluent volume 3820) to add to each patient mixing vial in step 3218. The user now selects the bulk antigen vial from the bulk antigen tray. To verify that the proper antigen vial has been pulled, the user toggles pull checkbox 3825. Upon receiving the toggle input in step 3220, ATAT computer system 100 highlights what should be the corresponding vial in the virtual bulk antigen vial antigen vial holder in step 3222. FIG. 39 shows a close-up view of a portion of virtual bulk antigen vial holder of the patient vial mixing screen of FIG. 37. Referring to FIG. 38, pull checkbox 3285 is shown toggled for Pine Mix 3805 and the well that should correspond to pine mix 3805 is distinguished from the other vials, as shown. More specifically, pine mix well 3905 is shown highlighted (in a different color) from the other wells. The wells on virtual antigen vial holder The user will then pull the corresponding vial from the actual bulk antigen vial holder. To verify that the correct vial has been actually pulled, the user will scan the barcode that is affixed to the antigen vial (see FIG. 15, barcode 1510 on antigen vial 1505). ATAT computer system 100 receives the barcode input in step 3224 and it is displayed in barcode field 3830 in step 3226. Next, ATAT computer system 100 determines if the barcode that was input matches the barcode for the antigen vial that should be pulled in step 3228. Because only one antigen vial for a designation (allergy testing or bulk antigen) should be open for each location, and because each antigen vial is assigned a position in an antigen vial holder, a match indicates that the proper antigen vial has been pulled (based on the assigned position of the bulk antigen vial profile described above with respect to allergy test kit preparation). If the barcode does not match, a warning is displayed (step 3230). If the barcodes match, then the virtual antigen vial well will be further distinguished in step 3232. FIG. 40 shows the close-up view of FIG. 39 after determining that the barcode on the bulk antigen vial scanned matches the antigen vial that should be pulled. In FIG. 40, pine mix 3905 changes to a different color indicator from FIG. 39 to indicate a match. After the user places the correct antigen amount in the patient vial, the user should place the antigen vial back into the original position in bulk antigen vial holder and toggle place checkbox 3832. When ATAT computer system 100 receives input that place checkbox 3832 has been toggled, in step 3234, the virtual antigen vial well reverts back to the original, non- highlighted, state in step 3238 and the estimated concentration for the antigen is updated in step 3236.

The process (steps 3220 to 3238) is repeated until all the patient antigens are added to the patient vial. For example, in FIG. 38, the process for preparing the initial pollen patient vial would be completed after adding pine mix and mulberry mix to the patient vial (the patient does not need the other antigens, so they are not added). Once the user has added all the patient specified antigens, submit button 3835 is selected. Upon receiving the submit button 3835 input in step 3239, ATAT computer system 100 will determine if any antigens that the patient requires have been missed in step 3240. If additional antigen must be added, a notice will be displayed to add the missing information in step 3242. The user will then complete steps 3220 to 3238 for the missing antigens and return to step 3239. If all antigen has been added and verified (step 3240), vent checkbox 4105 is displayed (step 3244) and available to be selected. Since vials are typically pressurized, venting is a process that assists mixing by releasing pressurized air from the vial.

FIG. 33 shows a flowchart illustrating a patient immunotherapy vial mixing process continued form FIG. 32. FIG. 41 shows a sequence of one column of virtual patient vial mixing tray 3720 of the patient vial mixing screen of FIG. 37 as a user completes mixing tasks. FIG. 41 illustrates the feature that the user is systematically guided through the creation of the patient vials in a stepwise manned with ATAT computer system 100 guiding the process. Once the initial vial has been vented, vent checkbox 4105 should be checked. ATAT computer system 100 will receive the input that vent checkbox 4105 has been toggled in step 3305. Mix checkbox 4110 will now be displayed in step 3310. Antigen from the bulk vial tray is loaded into the second patient mix vial as previously described in FIG. 32 (see steps 3210 to 3244) in step 3315. Step 3315 ends with displaying vent checkbox 4115 (see Fig. 40). The user will check vent checkbox 4115, and ATAT computer system 100 will receive the input in step 3320. Two patent vials are made with the same concentration so that one vial may be used as a maintenance dose and one used as a highest dose that is titrated further to make additional doses with lower concentrations.

The second patient vial mix will then be titrated over three more vials for each column. After ATAT computer system 100 receives input from vent checkbox 4115, titrate check box 4120 is displayed on the first titration vial in step 3325. The user will perform the titration step and toggle titrate check box 4120 when completed. ATAT computer system 100 will receive this input and display vent checkbox 4125 in step 3335. Once the titration vial is vented, the user will toggle vent checkbox 4025, and ATAT computer system will receive this input in step 3340. FIG. 41 only shows the first titration vial completed; the titration process is repeated until the last titration vial has received a "vent" input (step 3345).

If all the columns (mold, animal, pollens) have been mixed and titrated that the patient needs, a date is input into a date mixed or date compounded input field. Receiving the date in the date mixed input field (step 3345) will complete the mixing and titration process. In step 3350, the ATAT computer system may receive instruction to print a mixing labels for the patient based on what was mixed.

FIG. 42 shows an injection progress report screen. When a set of patient vials are filled, the patient can now begin the immunotherapy injections. When a patient enters the clinic, the patient's record may be accessed where an injection progress screen 4200 is displayed after selection by ATAT computer system 100. Injection progress screen 4200 shows the following column headers relating to the immunotherapy injection progress: Week Number 4202, Doses Total 4204, Mold Shot Amount 4206, Animal Shot Amount 4208, Pollen Shot Amount 4210, Shot Location 4212 (e.g., right arm or left arm), Notes 4214, Bill 4216, and Lock 4218. Status indicator 4220 can be in one of two states: a first state indicating an injection has occurred on a particular day or a second state indicating waiting for input (i.e., details of an injection). According to an embodiment of the present disclosure, status indicator 4220 is colored yellow if in the first state and colored blue if in the second state. Other colors may be used. Bill 4216 is selectable and displays the billing record for the injection of the corresponding row. If lock 4218 is toggled, an injection has occurred and has been recorded. Mold Shot Amount 4206, Animal Shot Amount 4208, and Pollen Shot Amount 4210 display the dose given or to be given to a patient. According to an embodiment of the present disclosure, these fields are color coded to match the patient vial color tops described above based on the dose given (e.g., the highest dose given is colored red according to an embodiment of the present disclosure).

FIG. 43 shows a flowchart illustration a patient immunotherapy injection process. As stated above, ATAT computer system 100 receives input to find a patient record in step 4305. Next, ATAT computer system 100 receives input to display injection progress report 4200 in step 4310. In step 4315, the injection progress screen 4200 is displayed with patient name and patient identification number loaded in the screen. The user will then click on a blue status indicator 4220 (step 4320) and an injection record screen will be displayed in step 4325. FIG. 44 shows an injection record screen 4400. FIG. 45 shows the injection record screen of FIG. 44 with sample data input. Injection record screen 4400 displays the type of antigen to administer, the amount of antigen to administer 4405 and which vial to draw from 4410 (step 4330). Vial to draw from 4410 is color coded to match the colored top of the patient vial to use (see FIG. 45 where corresponding location color matches the top of highest patient vial dose 3625 of FIG. 36). As stated above, similar color coding is displayed on injection progress report 4200 in the amount columns.

After giving the injection to the patient and waiting for a period of time (e.g., 15 minutes), the wheal is measured using the tool 1700 of FIG. 17. A wheal input field 4415 is also displayed where a user may input the value for the measured wheal. Alternatively, pollen response button 4420 may be selected which will display values; the user should select the value corresponding to the measured value. The user will either input the value of the measured wheel or select a value of the pollen reaction; ATAT computer system 100 will receive the input in step 4335. A pollen response will be displayed that corresponds to the pollen reaction input or selected in step 4340. The pollen response will be color coded. If the pollen response is yellow or red, a practitioner must review the injection progress and select a dose to give in step 4345. A green pollen response indicates that the next dose may be used. The practitioner should sign off on the injection procedure by entering the following which are received by ATAT computer system 100: a location where the injection occurred (step 4350), any notes (step 4355), decision to engage a spirometry test (step 4360), optional vitals, and signature with a time stamp (step 4365). Submitting the entered information to ATAT computer system 100 will generate a billing form and add the injection activity to the patient activity log in step 4370. With reference to the tool 1700, a red pollen response will be displayed if the reaction is greater than 50mm (greater than notch 1705 or opening 1745). If the reaction is greater than 25 mm and 50 mm (not exceeding notch 1705 or opening 1745 and exceeding notch 1710 or opening 1750), the pollen response is a yellow color. All reactions less than 25 mm will have a green color pollen response. The legend of tool may be color coded to match the pollen response colors: 50mm reactions: yellow; 25 mm reaction to 5 mm reaction: green; 3 mm: grey. Red may not be shown on the tool 1700 since anything pollen response greater than 50 mm will be color coded red. If a pollen response is red, the next dose the patient receives should be lower than the dose that caused a red pollen response. ATAT computer system 100 will prevent selecting a higher dose if a red pollen response is experienced.

Emergency Response

FIG. 46 shows a flowchart illustrating an emergency response process of the present disclosure. In the course of testing and treatment, antigen is provided to patients. A patient may have an adverse reaction to an allergen and may experience anaphylaxis, a life-threating allergic reaction. An emergency response button is displayed in step 4605 (e.g., crash chart button 1899; see FIG, 18). This button is displayed on screens related to activities where a patient is exposed to an antigen (i.e., during allergy testing and scoring, penicillin allergy testing and scoring, and immunotherapy). In the event the patient has an adverse reaction to an antigen, the emergency response button should be pressed. ATAT computer system receives an indication that the emergency response button has been actuated in step 4610. The ATAT computer system 100 logs details in a patient activity log regarding the cause of exposure (antigens, etc.) or what testing took place when the event occurred.

ATAT computer system 100 displays an "immediate treatment" screen in step 4615. The immediate treatment screen allows a user to input symptoms the patient is experiencing. According to one embodiment of the present disclosure, a checklist of symptoms is displayed: hives, difficulty breathing, blueness of the skin, itching anywhere on the body, chest tightness/pain, rapid, weak pulse, sweating, seizure-like activity or loss of consciousness, and decreased blood pressure. The user will select the patient's observed symptoms. An immediate action button is displayed. When the immediate action button is pressed, ATAT computer system 100 receives the selected symptoms in step 4620 and processes them to display a protocol for treating the adverse reaction in step 4625. The displayed protocol is a checklist of steps that the user should take. According to one embodiment of the present disclosure, the protocol displays the following steps: (1) Notify office personnel that an emergency is in progress. (2) Have the patient sit or lay down in a designated Emergency Treatment Room. (3) Check Airway, Breathing, and Circulation. Record respiratory rate, pulse, and blood pressure. If the pulse is low and strong, call the physician/practitioner before giving epinephrine. Record vital signs and observations, every 5 minutes during the entire course of treatment for a suspected anaphylactic reaction. (4) Administer Benadryl (Diphenhydramine) orally or intramuscularly ("IM"): Adults and children greater than 12 years take 50mg to lOOmg. Children less than 12 years of age take 25mg to 50mg. (5) If indicated, proceed with Epinephrine, given IM in any available site. If there is any doubt about the need for Epinephrine, GIVE IT: For adults, inject aqueous Epinephrine 1 : 1000 IM, 0.15-0.30 cc. For children, inject aqueous Epinephrine 1 : 1000 IM according to child's weight: 221bs is 0.10 cc; 441bs is 0.20 cc; 661bs is 0.30 cc. (6) Apply a tourniquet above the injection site of the offending agent. Loosen the tourniquet every 3 minutes. (7) Maintain an open airway and administer oxygen if respiratory distress is present. (8) Call the physician/practitioner STAT. Call 911 if the situation warrants. (9) Record all vital signs, observations, and medical treatment on the Emergency Treatment Record (select "Record" tab). (10) The physician/practitioner on site will direct any additional medical measures beyond what is outlined above. The user should check-off each protocol item (also called a standing order), as they are completed, so as to create a useful record that emergency medical services can use, and auditors can reference later. ATAT computer system 100 receives input of the items carried out in step 4630. A physician must sign and date the protocol display screen. One of the steps of the protocol is to record all vital signs, observations, and treatment provided. A record screen is displayed in step 4635 to assist a user in recording the vital signs, observations, and treatment provided. A tab or button leads a user to the record screen from the protocol screen. The record screen automatically populates the patient data based on the task that was under way when the adverse reaction occurred (allergy testing, penicillin allergy testing, or immunotherapy). The record screen provides input fields to record all vital signs, observations, and medical treatment during an anaphylaxis event.

According to an embodiment of the present disclosure: the record screen permits input of the following information: Patient Name, Weight, Time of Allergen Exposure, Dilution (Vial #), History of Prior Systemic?, Date of birth, Date of service, Nurse, Time of Reaction, New Vial?, Details, D assess ABC's, D Epinephrine IM, D Call EMS (911) (Y/N), Time Called, Signs & Symptoms, Respiratory, Skin, Nasal/Ocular, Vascular, Other, Shortness of Breath, Wheezing, Cough, Stridor, Urticaria, Angioedema, Generalized Pruritis, Flushing, Rhinorrhea, Congestion, Sneezing, Red Eyes, Hyptotension, Chest Discomfort, Dizziness, Headache, Difficulty Swallowing, Abdominal Discomfort, Diaphoresis, Sense Impending Doom, Vital Signs (update every 5 minutes initially), Treatment, Time, Blood Pressure, Heart Rate, RR, 02 Sat, Observations, Medication, Dose, Rout, Time, Initials, Time of Discharge from Clinic, Condition, Patient Instructions, Follow-up Call to Patient (date, findings, advice), Comments, Clinical Impression (true SR, possible SR, no SR), and Systemic Severity Classification (EAACI, Portnoy, and WAO). Required fields are highlighted in red. A vital sign input table is provided to input vital signs periodically. For example, a given protocol may suggest input of vital signs every five minutes. The user will input vital signs, observations, and treatment given which will received by AT AT computer system 100 in step 4640.

A systematic severity classification should be input. The ATAT provides at least three grading methodology selections that are displayed in step 4645. The user can choose the methodology that the practitioner prefers. Buttons for the various methodologies are provided: EAACI, Portnoy, WAOt. A field for the grading is provided next to the methodology button. Clicking the methodology button displays the grading criteria for the selected methodology. The user can review the grading criteria prior to inputting a grading. According to an embodiment of the present disclosure, only one grading methodology may be used to grade an adverse reaction. A grade input is received by ATAT computer system 100 in step 4650. Initials and signature should be input by the user after all necessary information has been input. The physician's signature and date are received by the ATAT computer system in step 4655.

Mix Billing

FIG. 47 shows a flowchart illustrating a patient billing process of the present disclosure. One of the administrative tasks that must be carried out is billing for mixing patient vials. Vials for a patient are mixed at one time, but the injection process and billing for the injections occurs over time. After mixing vials for a patient, ATAT computer system 100 displays a billing button (display billing button step 4705). Selecting the billing button (step 4710) will display a billing form (step 4715).

FIG. 48 shows a billing screen. Billing screen 4800 of FIG. 48 shows five sections that correspond to the five doses of patient vials mixed (see FIG. 36). The billing form is color coded to match the corresponding patient vial top. Each section has a note box 4805. Selecting or tapping note box 4805 pre-populates the note box or custom text may be input. The text in note box 4805 is a description of the item/service billed to insurance. ATAT computer system 100 receives note box input in step 4720. Date of Service, Time, Tech Initials, and Practitioner fields are provided for input. When ATAT computer system 100 receives input for these fields in step 4725, complete button 4850 is displayed in step 4730. ATAT computer system 100 receives input that complete button has been actuated in step 4735. Actuating the complete button will enter the event in the patient activity log and the billing process will be carried out. ATAT computer system 100 determines if the insurance company policy linked with the patient is an incremental billing policy in step 4740. ATAT computer system 100 does this by comparing the patient's insurance provider associated with the patient's profile with an insurance company policy profile or insurance company data table. If the insurance company being billed has an incremental billing policy, ATAT computer system 100 will generate a billing reminder in step 4745 that will notify a user in a given amount of time. The user will be notified to bill again via display of the billing reminder in step 4750. The billing reminder will be displayed in clinic notifications 435 (see FIG. 4). The billing form is used to generate a bill in step 4755. The bill is delivered to the insurance company for processing.

FIG. 49 shows a flowchart illustrating a purchase order process. As inventory is consumed, additional inventory must be purchased. ATAT computer system 100 allows user to generate purchase order forms. In step 4905, ATAT computer system 100 receives input for a new purchase order. Upon receiving such input, a unique purchase order number is generated in step 4910. The user will input a date the order will be submitted for approval to a purchasing manager, a vendor (optional; a purchase order administrator will make a final selection of the vendor according to an embodiment of the present disclosure), and a clinic. ATAT computer system 100 will receive the input for the date, vendor (if selected), and clinic in steps 4915, 4920, and 4925 respectively. The user will input an item number or product name that will be ordered and ATAT computer system 100 receives this input in step 4930. A quantity is input by the user and received by ATAT computer system 100 in step 4930. The purchase order is then submitted for approval in step 4940. A purchasing manager will review the purchase order and submit it.

FIG. 50 shows a flowchart showing a receive purchase order inventory process. When a purchase order is submitted for approval, the inventory item ordered has a status of "out" (step 5005). When an item arrives, the status must be changed. ATAT computer system 100 displays a received now button in step 5010. When the received now button is actuated and received by ATAT computer system 100 (step 5015), a dialog box is displayed that ask for the number of items received in step 5020. The user inputs the number received and ATAT computer system receives the input in step 5025. ATAT computer system 100 will update the received number of items in step 5030. Also, the number of items that are still outstanding will be updated based on the items received. in step 5035. Once all the items are received for a purchase order, the purchase order may be closed by inputting a date into a date closed field. The ATAT computer system 100 will give the purchase order a closed status in step 5045. The purchase order information updates a purchase order list view (similar to the inventory item list view described above) that displays purchase order number, clinic, vendor, date ordered, date closed, and status (requested, shipped, received, etc.). Detailed information about the purchase order is available by selecting a particular purchase order.

Different embodiments, methods, applications, advantages, and features of the present disclosure have been described above; however, these particular embodiments, methods, applications, advantages, and features should not be construed as being the only ones that constitute the practice of the systems and methods hereof. Indeed, it is understood that the broadest scope of this disclosure includes modifications. Further, many other applications and advantages of applicant's systems and methods will be apparent to those skilled in the art from the above descriptions and the below claims.

Claims

lat is claimed is:

A method related to providing allergy-related medical services, said method comprising the steps of a) generating unique identifiers and permitting printing of said generated unique identifiers in a computer-readable form, each printed unique identifier to be affixed to an antigen vial; b) receiving input to create antigen vial profiles; c) computer-reading printed unique identifiers affixed to antigen vials to input and associate the computer-read printed unique identifier with a corresponding antigen vial profile; d) receiving input designating an antigen vial corresponding to an antigen vial profile for allergy testing or bulk antigen used to build patient vials for immunotherapy; e) receiving input assigning a position an antigen vial occupies on an antigen vial holder and storing an assigned position within a corresponding antigen vial profile; f) receiving input and storing storage location of antigen vials within the corresponding antigen vial profiles; g) storing a volume value of each antigen vial within each antigen vial profile; h) storing an expiration date for each antigen vial within each antigen vial profile; i) receiving input to create patient profiles and storing patient identifying information with patient profiles; and j) assisting determining what types of antigens elicit an allergic reaction and are immunotherapy candidates for patients by guided building of allergy test kits from antigen vials in antigen vial holders used for allergy testing by verifying proper loading of allergy testing kits, such allergy testing kits having antigen loading reservoirs, with antigen from an antigen vial holder used for allergy testing by displaying a virtual antigen vial holder in a color that matches the color of the antigen vial holder that should be used, displaying a virtual antigen testing kit, displaying, for each antigen loading reservoir of an allergy test kit, the position on the virtual antigen vial holder from which antigen should be drawn and loaded into a corresponding antigen loading reservoir on the allergy test kit, and, while displaying a particular position on a virtual antigen vial holder from which antigen should be drawn, computer-reading printed unique identifiers on an antigen vial pulled from an antigen vial holder and comparing a computer-read unique identifier on the antigen vial pulled with a unique identifier stored in position-corresponding antigen vial profile.

The method of claim 1 further comprising the steps of receiving and storing patient- specific allergic reaction values for antigens tested.

The method of claim 2 further comprising the step of assisting compounding patient- specific immunotherapy vial sets used to administer immunotherapy injections based on the patient-specific allergic reaction values stored for a particular patient by guiding building of patient-specific immunotherapy vial sets from antigen vials in antigen vial holders designated as bulk antigen used to build patient vials for immunotherapy by verifying proper compounding of patient-specific immunotherapy vial sets by displaying a virtual bulk antigen vial holder and a virtual patient vial set and, upon receiving input selecting a virtual patient vial from a displayed virtual patient vial set; displaying, for each antigen to be loaded into a patient vial, the position on the virtual bulk antigen vial holder from which antigen should be drawn and loaded into a patient vial, displaying concentrations to be removed from bulk antigen vials and loaded into a patent vial, and, computer reading printed unique identifiers on bulk antigen vials pulled from a bulk antigen vial holder and comparing the computer-read unique identifier on the bulk antigen vial pulled with the unique identifier stored in a position-corresponding bulk antigen vial profile; and assisting providing immunotherapy dose decisions for a patient based on input values of immunotherapy observations.

The method of claim 1 further comprising the step of, prior to the step of assisting determining what types of antigens elicit an allergic reaction and are immunotherapy candidates for patients, displaying patient screening questions, receiving input answering the patient screening questions, and permitting access to features assisting determining what types of antigens elicit an allergic reaction and are immunotherapy candidates for a patient if answers to patient screening questions do not indicate allergy testing risk or if an override to permit allergy testing despite allergy testing risk is input, and receiving input corresponding to patient informed consent to allergy testing or treatment.

The method of claim 1 further comprising the step of

a) receiving input in an antigen vial profile that an antigen vial at a storage location has an open status indicating it is actively being used; and

b) assisting preventing storing an open status for another antigen vial used for the same designation, either for allergy testing or bulk antigen used to build patient vial for immunotherapy, at the same storage location if such an antigen vial profile has an open status by displaying an alert preventing assigning a position of such antigen vial.

The method of claim 1 further comprising the steps of:

a) receiving input to begin building an allergy testing kit;

b) receiving input selecting an allergy testing type; and

c) displaying a virtual antigen vial holder used to build an allergy testing kit for a selected allergy testing type, the virtual antigen vial holder displaying a plurality of representation of vial wells organized in panel groupings identified by a virtual panel grouping indicator, each panel grouping comprising a subset of the plurality of representation of vial wells, and each virtual panel grouping indicator displaying a color, and each virtual panel grouping indicator color being a different color from other virtual panel grouping indicator colors of a virtual antigen vial holder, the virtual antigen vial holder corresponding to an actual antigen vial holder that should be used to build the allergy testing kit for the selected allergy testing type, the actual antigen vial holder having characteristics of a color, a plurality of vial wells organized in panels, each panel comprising a subset of the plurality of vial wells organized in panel groupings identified by a panel grouping indicator, the panel grouping indicators each having a color, the characteristics of the actual antigen vial holder providing visual assurance that a proper actual antigen vial holder is used by color correspondence of an actual antigen vial holder and the virtual antigen vial holder;

assisting loading a panel from an actual vial holder into an allergy testing kit by i) receiving input selecting a virtual panel grouping indicator;

ii) displaying a virtual panel grouping according to the selected virtual panel grouping indicator and a virtual allergy test kit, the virtual panel grouping comprising vial well representations each displaying an antigen name, the virtual allergy test kit being a representation of an actual allergy testing kit having reservoirs to receive antigen, and the virtual allergy test kit displaying representations of reservoirs corresponding to vial well representation of the virtual panel grouping, and an antigen name displayed in close proximity to each reservoir of the representation of reservoirs of the allergy test kit;

iii) receiving input selecting a representation of a reservoir of the virtual allergy test kit and in response changing the color of a corresponding vial well representation of the virtual panel grouping from an initial color to another color;

iv) computer-reading the unique identifier affixed to a selected antigen vial from the actual antigen vial holder;

v) determining if the computer-read unique identifier matches the unique identifier stored in the antigen vial profile assigned to the position of the antigen vial that should be used in the actual antigen vial holder; and vi) receiving input that antigen has been added to a reservoir of the allergy test kit and changing the color of the corresponding vial well representation of the displayed virtual panel grouping to its initial color.

The method of claim 6 further comprising the step of displaying an allergy testing scoring screen comprising a listing of antigens for a selected allergy testing type, the listing of antigens grouped into panel scoring groups, each panel scoring group comprising a color scheme that matches a related virtual panel grouping indicator color, and each panel scoring group displaying a measured allergic reaction input field.

The method of claim 6 further comprising the steps of

a) receiving input to initiate compounding patient-specific immunotherapy vial sets and displaying a virtual patient immunotherapy vial rack comprising virtual interactive patient immunotherapy vial representations and a virtual bulk antigen vial holder comprising bulk antigen vial well representations corresponding to positions on an actual bulk antigen vial holder, and a mixing location input field; b) receiving and storing input indicating the mixing location input field;

c) receiving input to mix a patient immunotherapy vial;

d) displaying a mix verification screen listing antigens to be added to the patient immunotherapy vial, the antigens to be added based on patient-specific allergic reaction values stored for a particular patient; e) displaying a concentration of antigen to add from a bulk antigen vial into a patient immunotherapy vial;

f) receiving input selecting an antigen and changing the color of the bulk antigen vial well representation of a selected antigen on the virtual bulk antigen vial holder to display the position of the antigen vial that should be used from the actual bulk antigen vial holder;

g) computer-reading the unique identifier affixed to an antigen vial used from the actual antigen vial holder;

h) determining if the computer-read unique identifier affixed to the antigen vial used from an actual bulk antigen vial holder matches a unique identifier stored in the antigen vial profile assigned to the position from which the antigen vial should be used in the actual bulk antigen vial holder and displaying an alert if there is not a match;

i) receiving input that antigen has been added to the patient immunotherapy vial; j) receiving input that diluent has been added to the patient immunotherapy vial; and k) determining that all the antigens to be added based on patient-specific allergic reaction values stored for a particular patient have been added to the patient immunotherapy vial.

The method of claim 8 further comprising the steps of

a) assisting titration of a patient's immunotherapy vial to generate patient immunotherapy vials of varying doses;

b) displaying a titrate input field;

c) displaying titration instructions;

d) receiving input that titration has occurred from one patient immunotherapy vial into another patient immunotherapy vial; e) displaying a vial venting input field after receiving input that titration has occurred; and

f) receiving input that a vial venting activity has completed.

10. The method of claim 9 wherein the step of assisting compounding patient-specific immunotherapy vial sets is completed when, per antigen type, at least two patient immunotherapy vials with the same concentration are compounded, a first of said at least two patient immunotherapy vials having a concentration used for immunotherapy maintenance and a second of said at least two patient immunotherapy vials used for immunotherapy at a highest dose and further used to generate at least three more patient immunotherapy vials by titration establishing at least three more patient immunotherapy vials with different doses lower than said second of said at least two patient immunotherapy vials, and each compounded patient immunotherapy vial has a colored top representing a dose.

11. The method of claim 10 further comprising the step of updating a volume value in an antigen vial profile after receiving input that antigen has been used in building an allergy testing kit or compounding patient immunotherapy vials.

12. The method of claim 10 further comprising the steps of recording immunotherapy progress comprising the steps of

a) displaying a dose concentration from a patient immunotherapy vial to inject into a patient and displaying a color to indicate which dose of patient immunotherapy vial to use, the displayed color matching the color of a top of the patient immunotherapy vial to use;

b) receiving input of a measured allergic response;

c) generating a pollen response and displaying a color associated with the pollen response; and d) assisting determining if a higher or lower dose of antigen mix should be given to a patient based on the pollen response.

13. The method of claim 12 further comprising the step of measuring an allergic response using an allergic response measuring tool comprising an edge with a plurality of notches of different lengths used to measure allergic reactions dimensions, each notch displaying a legend indicating a length of an associated notch, and, associated with each notch, a plurality of openings of different diameters, the diameters of the openings having the same value as the length of the associated notch, the notches associated with the openings by alignment, and color indications associated with notch and associated openings, the color indications matching a pollen response color when giving immunotherapy.

14. The method of claim 12, further comprising the steps of assisting billing a patient's health insurance company for compounding patient immunotherapy vial sets by comparing a patient's insurance company stored in a patient profile to a stored insurance company billing policy and generating a reminder to bill a patient's insurance company if a patient's insurance company billing policy is an incremental billing policy.

15. The method of claim 1 further comprising assisting penicillin allergy testing comprising the steps of

a) receiving input selecting penicillin skin prick testing;

b) displaying a penicillin skin pick testing screen of a penicillin skin prick test comprising a display of a virtual penicillin skin prick test sticker and a list of tasks to be completed to administer penicillin skin prick testing;

c) receiving input that a penicillin skin prick test sticker has been placed on a patient, the penicillin skin prick test sticker comprising a skin access opening for a positive control, a skin access opening for a negative control, and skin access openings for penicillin antigens;

d) displaying an initial penicillin skin prick testing timer; e) receiving input to start an initial penicillin skin prick testing timer after applying a positive control and a negative control on a patient's skin in the openings of the penicillin skin prick test sticker;

f) displaying score input fields for the positive control and negative control when the initial penicillin skin prick testing timer has completed;

g) receiving input values for the positive control and negative control score input fields;

h) determining if the positive control and negative control tests are valid, and, if so, displaying timers associated with penicillin antigens to be tested;

i) receiving input to start the timers after penicillin antigen has been applied to a patient's skin in the openings corresponding to the penicillin antigen; j) displaying score input fields for the penicillin antigens tested when timers complete;

k) receiving input values for the penicillin antigens tested;

1) determining, based on the input values, if the patient had a negative or positive reaction to the penicillin antigen tested; and

m) preventing display of further penicillin testing if any of the penicillin antigens tested elicited a positive reaction and only permitting access to a penicillin intradermal testing screen if all reactions are negative.

16. The method of claim 15 further comprising the steps of

a) receiving input selecting penicillin intradermal testing;

b) displaying a penicillin intradermal testing screen comprising a display of a virtual penicillin intradermal test sticker and a list of tasks to be completed to administer penicillin intradermal testing; c) receiving input that a penicillin intradermal test sticker has been placed on a patient, the penicillin intradermal test sticker comprising a skin access opening for a negative control, and skin access openings for penicillin antigens; d) displaying an initial penicillin intradermal testing timer;

e) receiving input to actuate the initial penicillin intradermal testing timer after applying a penicillin intradermal test negative control on a patient in a skin access opening of a negative control test of the penicillin intradermal test sticker;

f) displaying a score input field for the negative control test of a penicillin intradermal test when an initial penicillin intradermal testing timer has completed; g) receiving input values in the score input field for the negative control test of the penicillin intradermal test;

h) determining if the negative control test of the penicillin intradermal test is valid, and, if so, displaying timers associated with the penicillin antigens to be tested if the negative control test is valid;

i) receiving input to start the timers after applying penicillin antigen in the openings of the penicillin intradermal test sticker;

j) displaying score input fields for penicillin antigens tested when the timers complete;

k) receiving input values for penicillin antigens tested;

1) determining, based on received input values for penicillin antigens tested, if the patient had a negative or positive reaction to penicillin antigens tested; and m) preventing display of further penicillin testing if any of the penicillin antigens tested elicited a positive reaction and only permitting access to an amoxicillin testing screen if all reactions are negative.

17. The method of claim 16 further comprising the steps of:

a) receiving input selecting amoxicillin testing; b) receiving input to start an initial amoxicillin test timer after administering a first dose of amoxicillin to a patient;

c) displaying a first dose amoxicillin reaction input field after the initial amoxicillin test timer completes;

d) receiving input of the reaction to the first dose of amoxicillin and determining if the patient had a positive or negative reaction;

e) only displaying a subsequent amoxicillin test timer if the received input of an observed reaction to the first dose of amoxicillin was negative;

f) receiving input to start the subsequent amoxicillin test timer after administering a second dose of amoxicillin to a patient;

g) displaying a second dose amoxicillin reaction input field after the subsequent amoxicillin test timer completes; and

h) receiving input of the observed reaction to the second dose of amoxicillin and determining if the patient had a positive or negative reaction.

18. The method of claim 1 further comprising the steps of assisting documenting a patient adverse reaction by receiving input that a patient is experiencing an adverse reaction, displaying procedures to deal with an adverse reaction, receiving input in accordance with displayed procedures to deal with an adverse reaction, and logging an adverse reaction to a patient profile.

19. The method of claim 1 further comprising the step of alerting need to order antigen when a volume value of an antigen vial profile equals or is lower than a set volume value or if the expiration date in the antigen vial profile is approaching a date threshold.

20. An allergy testing and treatment system comprising at least one computer system configured to

a) store patient profiles;

b) store clinic profiles; c) store user profiles;

d) store inventory profiles associated with a unique identification barcode that corresponds to a printed barcode on inventory items;

e) assist reordering inventory items;

f) store position of an antigen vial inventory item in an antigen vial inventory profile, the stored position corresponding to an antigen vial position in an antigen vial holder;

g) assist administering allergy testing by verifying that a proper antigen vial is used to build an allergy test kit by computer-reading and determining if a barcode on an antigen vial chosen for use from a positon on an antigen vial holder matches the barcode stored in the antigen vial inventory profile for a corresponding stored position;

h) assist administering penicillin allergy testing by preventing progress through penicillin allergy testing if penicillin allergy testing indicates that penicillin allergy testing should stop;

i) assist compounding patient immunotherapy vial sets by verifying that the proper antigen vial is used by computer-reading and determining if a barcode on an antigen vial chosen for use from a positon on an antigen vial holder matches the barcode stored in the antigen vial inventory profile for the corresponding stored position; and

j) assist scoring immunotherapy progress using an input screen to inputs measured allergic reaction measurements to determine immunotherapy dose adjustment.