A system and a method for monitoring and improving end-user proficiency in medical imaging and diagnostic devices

Abstract

According to this disclosure, a method for assessing a user proficiency in operating one or more medical imaging and diagnostic devices includes receiving, by a communication module, the data captured by a user; processing, by a monitoring module, the data in order to assign at least one score with respect to at least one parameter; evaluating, by an evaluation module, the at least one score assigned to the data based on a predetermined threshold; assigning, by a grading module, one or more grades to the data based on the evaluation, corresponding to an assessment of the user's proficiency in operating the one or more medical imaging and diagnostic devices and the user's captured data; triggering, by the training module, a retraining of the user upon determining that a performance of the user with respect to capturing the data is below a predetermined threshold value.

Description

[0001] A SYSTEM AND A METHOD FOR MONITORING AND IMPROVING END-USER PROFICIENCY IN MEDICAL IMAGING AND DIAGNOSTIC DEVICES

[0002] FIELD

[0003] 1. The present invention relates to medical devices and, more particularly, to a system and method for continuously assessing and improving the proficiency of end users in operating medical imaging and diagnostic devices, such as ultrasound machines, ECG systems, colposcopes, dermatoscopes, X-ray machines, and a microscope used to support cytology and histopathology.

[0004] BACKGROUND

[0005] 2. In medical diagnostics, the proficiency of healthcare professionals in using imaging and diagnostic devices is critical for accurate diagnosis and treatment. Devices such as ultrasound machines, ECG systems, X-ray machines, colposcopes, dermatoscopes, and others require consistent and correct usage to ensure the accuracy of patient data collection. Variability in user skill levels can lead to poor image or signal quality, which can compromise patient care. Continuous training and proficiency assessment are needed to maintain high standards, but current solutions do not automatically monitor user performance over time.

[0006] SUMMARY

[0007] 3. Embodiments of the present invention disclose a Continuous Quality Assessment (CQA) system for assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by a user. According to some embodiments, the CQA system includes a communication module configured to receive the data captured by the user via the one or more medical imaging and diagnostic devices as an input; a monitoring module configured to process the data in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data; an evaluation module configured to evaluate the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter; and a grading module configured to assign a one or more grades to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices, wherein the passing score and the failing score corresponds to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices and the data captured by the user.

[0008] According to some embodiments, the one or more medical imaging and diagnostic devices is selected from a group consisting of an ultrasound machine, an Electrocardiogram (ECG) system, a colposcope, a dermatoscope, a fundus imaging system, a spectroscopy system, an X-ray machine and a microscope used to support cytology and histopathology.

[0009] According to some embodiments, the plurality of parameters comprises an ability of the user to capture one or more high quality images of at least one specific anatomical area, when the user is capturing the data via an ultrasound machine; an ability of the user to capture one or more high quality images of at least one specific anatomical area, when the user is capturing the data via a fundus imaging system; an ability of the user to capture one or more high quality spectra of at least one bio- fluid, and a signal quality obtained from the at least one bio-fluid when the user is capturing the data via a spectroscopy system; a proper lead placement, a signal quality, an adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals when the user is capturing the data via an ECG machine; an ability of the user to position a patient correctly and adjust one or more imaging parameters, a clarity and an exposure of one or more captured images when the user is capturing the data via an X-ray machine; an ability of the user to capture a clear image of a cervix relative to other relevant anatomical areas of the patient, to check a correct focus, a positioning, and illumination while capturing the clear image, a sharpness, a focus, and an image quality of the cervix and the other relevant anatomical areas of the patient in the clear image when the user is capturing the data via a colposcope; and a skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution images when the user is capturing the data via a dermatoscope.

[0010] According to some embodiments, the one or more high quality images of the at least one specific anatomical area captured by the ultrasound machine and the fundus imaging system is with a clarity, a focus, and an anatomical accuracy. According to some embodiments, the evaluation module is configured to evaluate the at least one score by determining whether or not the at least one score associated with the at least one parameter is greater than the predetermined threshold for the at least one parameter.

[0011] According to some embodiments, the grading module is configured to assign the one or more grades assigning a weight to the at least one score. The weight is assigned based on a significance of the at least one parameter with respect to the data and the one or more medical imaging and diagnostic devices used for capturing the data.

[0012] According to some embodiments, the CQA system further comprises the communication module configured to transmit the one or more grades to one or more personnel.

[0013] According to some embodiments, the one or more personnel is selected from a group consisting of: the user, a supervisor, and an administrator.

[0014] According to some embodiments, the CQA system further comprises a training module configured to suggest a personalized training module to the user based on the one or more grades.

[0015] According to some embodiments, the CQA system further comprises the monitoring module configured to determine that a performance of the user with respect to capturing the data with the predefined quality level is below a predetermined threshold value; and the training module configured to trigger a retraining of the user based upon the determination, wherein the retraining is automatically generated and customized with respect to the performance of the user. According to some embodiments, the CQA system further comprises a display module configured to generate a display module configured to generate a user interface configured to allow an access of performance data comprising the at least one score against the predetermined threshold, the one or more grades, a personalized training module to one or more personnel, and one or more previous grades assigned to previous data associated with the one or more medical imaging and diagnostic devices.

[0016] According to some embodiments, the CQA system further comprises the display module configured to present one or more questions and one or more user specific questions on the user interface separately post the operating of the one or more medical imaging and diagnostic devices; and receive one or more responses corresponding to the one or more questions from a patient and one or more responses corresponding to the one or more user specific questions from the user as feedback.

[0017] Embodiments of the present invention disclose a method for assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by a user. According to some embodiments, the method includes receiving, by a communication module, the data captured by the user via the one or more medical imaging and diagnostic devices as an input; processing, by a monitoring module, the data in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data; evaluating, by an evaluation module, the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter; and assigning, by a grading module, a one or more grades to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices, wherein the passing score and the failing score corresponds to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices and the data captured by the user. 16. The objects and advantages of the embodiments will be realized and achieved at least by the elements, features, and combinations particularly pointed out in the claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed.

[0018] BRIEF DESCRIPTION OF THE DRAWINGS

[0019] 17. Non-limiting examples of embodiments of the disclosure are described below with reference to figures attached hereto that are listed following this paragraph. Identical features that appear in more than one figure are generally labeled with the same label in all the figures in which they appear. A label indicating an icon representing a given feature of an embodiment of the disclosure in a figure may be used to reference the given feature. Dimensions of features shown in the figures are chosen for convenience and clarity of presentation and are not necessarily shown to scale.

[0020] 18. The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanied drawings. Embodiments of the invention are illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals indicate corresponding, analogous or similar elements, and in which:

[0021] FIG. 1 is an environment depicting an interaction between a system configured to assess a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by the user and the one or more medical imaging and diagnostic devices, according to some embodiments;

[0022] FIG. 2 shows a high-level block diagram of a system configured to assess a user proficiency in operating one or more medical imaging and diagnostic devices 105 and data captured by the user and the one or more medical imaging and diagnostic devices, according to some embodiments;

[0023] FIG. 3 is a flow diagram elaborating a process of assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by the user, according to some embodiments;

[0024] FIG. 4 illustrates an architectural diagram depicting an assessment of a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by the user, according to some embodiments;

[0025] FIG. 5a is an image of a user interface depicting a login screen for a user of the system, according to some embodiments; 24. FIG. 5b is an image of a user interface depicting a patient management screen, according to some embodiments;

[0026] 25. FIG. 5c is an image of a user interface depicting a procedure screen presented to the user while the user is capturing the data via the one or more medical imaging and diagnostic devices, according to some embodiments; and

[0027] 26. FIG. 6 is a flow diagram of a method for assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by the user, according to some embodiments.

[0028] 27. It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn accurately or to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity, or several physical components may be included in one functional block or element. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

[0029] DETAILED DESCRIPTION

[0030] 28. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components, modules, units and / or circuits have not been described in detail so as not to obscure the invention. Some features or elements described with respect to one embodiment may be combined with features or elements described with respect to other embodiments. For the sake of clarity, discussion of same or similar features or elements may not be repeated.

[0031] Although embodiments of the invention are not limited in this regard, discussions utilizing terms such as, for example, “processing”, “computing”, “calculating”, “determining”, “establishing”, “analyzing”, “checking”, or the like, may refer to operation(s) and / or process(es) of a computer, a computing platform, a computing system, or other electronic computing device, that manipulates and / or transforms data represented as physical (e.g., electronic) quantities within the computer's registers and / or memories into other data similarly represented as physical quantities within the computer's registers and / or memories or other information non-transitory storage medium that may store instructions to perform operations and / or processes. Although embodiments of the invention are not limited in this regard, the terms “number” and “a number” as used herein may include, for example, “multiple” or “two or more”. The terms “number” or “a number” may be used throughout the specification to describe two or more components, devices, elements, units, parameters, or the like. The term set when used herein may include one or more items. Unless explicitly stated, the method embodiments described herein are not constrained to a particular order or sequence. Additionally, some of the described method embodiments or elements thereof can occur or be performed simultaneously, at the same point in time, or concurrently.

[0032] FIG. 1 is an environment depicting an interaction between a CQA system 100 configured to assess a user proficiency in operating one or more medical imaging and diagnostic devices 105 and data captured by the user and the one or more medical imaging and diagnostic devices 105, according to some embodiments. In accordance with an embodiment of the present subject matter, the CQA system 100 may be configured to receive data as an input from a user. The data may be captured by the one or more medical imaging and diagnostic devices 105 being operated by the user. In response to receiving the data, the CQA system 100 may be configured to process the data. The data may be processed in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data. Upon a successful processing of the data, the CQA system 100 may be configured to evaluate the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter. To that understanding, the CQA system 100 may further be configured to assign one or more grades to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices. The passing score and the failing score may correspond to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices and the data captured by the user.

[0033] FIG. 2 shows a high-level block diagram of a CQA system 100 configured to assess a user proficiency in operating one or more medical imaging and diagnostic devices 105 (as shown in FIG. 1) and data captured by the user and the one or more medical imaging and diagnostic devices 105, according to some embodiments. In one embodiment, the CQA system 100 may be incorporated in User Equipment (UE). Examples of the UE may include, but are not limited to, a Personal Computer (PC), a laptop, a smartphone, and a tablet. The CQA system 100 may be communicating with the one or more medical imaging and diagnostic devices 105 via one of a wired communication standard and a wireless communication standard. Examples of the wired communication standard may include, but are not limited to, Local Area Network (LAN), Metropolitan Area Network (MAN), and Wide Area Network (WAN). Examples of the wireless communication standard may include, but are not limited to, Bluetooth, and Wi-Fi, infrared. In another embodiment of the present subject matter, the CQA system 100 may be incorporated within the one or more medical imaging and diagnostic devices 105 (as shown in FIG. 1).

[0034] As shown, the UE may include the CQA system 100, a controller 205, an operating system 210, a memory 215, an executable code 220, an input means 225, output devices 230, and a communication module 235. The CQA system 100 may include a monitoring module 240, an evaluation module 245, a grading module 250, a training module 255, and a display module 260.

[0035] The controller 205 may be, for example, a central processing unit processor (CPU), a chip or any suitable computing or computational device. The controller 205 (or one or more controllers or processors, possibly across multiple units or devices) may be configured (e.g., by executing software or code) to carry out methods described herein, and / or to execute or act as the various modules, units, etc.

[0036] The operating system 210 may be or may include any code segment (e.g., one similar to the executable code described herein) designed and / or configured to perform tasks involving coordination, scheduling, arbitration, supervising, controlling or otherwise managing operation of the CQA system 100; for example, scheduling execution of software programs or enabling software programs or other modules or units to communicate. The operating system 210 may be a commercial operating system, e.g., Android or iOS.

[0037] The memory 215 may be or may include, for example, a Random- Access Memory (RAM), a read only memory (ROM), a Dynamic RAM (DRAM), a Synchronous DRAM (SD-RAM), a double data rate (DDR) memory chip, a Flash memory, a volatile memory, a non-volatile memory, a cache memory, a buffer, a short term memory unit, a long term memory unit, or other suitable memory units or storage units. The memory 215 may be or may include a number of, possibly different memory units. The memory 215 may be a computer or processor non-transitory readable medium, or a computer non-transitory storage medium, e.g., a RAM. Some embodiments may include a non-transitory storage medium having stored thereon instructions which when executed cause the processor to carry out methods disclosed herein.

[0038] The executable code 220 may be any executable code, e.g., an application (app), a program, a process, task or script. The executable code 220 may be executed by the controller 205 possibly under control of the operating system 210. Although, for the sake of clarity, a single item of executable code 220 is shown in FIG. 2, the system according to some embodiments of the invention may include a number of executable code segments similar to the executable code 220 that may be loaded into the memory 215 and cause the controller 205 to carry out methods described herein. The input means 225 may be or may include a mouse, a keyboard, a touch screen or pad or any suitable input device. It will be recognized that any suitable number of input devices may be operatively connected to the CQA system 100. The output devices 230 may include one or more monitors, speakers and / or any other suitable output devices. It will be recognized that any suitable number of output devices may be operatively connected to the CQA system 100. Any applicable input / output (I / O) devices may be connected to the CQA system 100. For example, the input means 225 and the output devices 230 may include a wireless network interface component (e.g., a WiFi system or component), a Bluetooth component and the like. To that understanding, in one embodiment, the display module 260 may be one of the output devices 230.

[0039] The CQA system 100 according to some embodiments of the invention may include components such as, but not limited to, a number of central processing units (CPU) or any other suitable multi-purpose or specific processors or controllers (e.g., controllers similar to the controller 205), a number of input units, a number of output units, a number of memory units, and a number of storage units.

[0040] The CQA system 100 may be configured to receive the data captured by the user. The user may capture the data via the one or more medical imaging and diagnostic devices 105 as an input. Examples of the one or more medical imaging and diagnostic devices 105 may include, but are not limited to, an ultrasound machine, an Electrocardiogram (ECG) system, a colposcope, a dermatoscope, a fundus imaging system, a spectroscopy system, an X-ray machine, and a microscope used to support cytology and histopathology. The ultrasound machine may be used to capture real-time images of internal organs and tissues. The ECG machine may be used to record an electrical activity of a heart. The X-ray machine may be used to capture images of bones and internal structures. The colposcope may be used to examine a cervix, a vagina, and a vulva for abnormalities, commonly employed in cervical cancer screening. The dermatoscope may be used to magnify and assess skin lesions, aiding in a diagnosis of conditions like melanoma. In an embodiment, the one or more medical imaging and diagnostic devices 105 may also include a Magnetic Resonance Imaging (MRI) machine and a mammography device for which medical data is captured by the user.

[0041] Upon receipt of the data by the CQA system 100, the monitoring module 240 may be configured to process the data. The data may be processed in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data. For processing the data to assign the at least one score with respect to the at least one parameter, the monitoring module 240 may be configured to assess the at least one parameter amongst the number of parameters based on a type of the one or more medical imaging and diagnostic devices 105 used to capture the data. Examples of the number of parameters may include, but are not limited to:

[0042] ■ an ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy, when the user is capturing the data via an ultrasound machine; an ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy, when the user is capturing the data via a fundus imaging system;

[0043] an ability of the user to capture one or more high quality spectra of at least one bio-fluid, and a signal quality obtained from the at least one bio-fluid when the user is capturing the data via a spectroscopy system; a proper lead placement, a signal quality, and an adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals when the user is capturing the data via an ECG machine;

[0044] an ability of the user to position a patient correctly and adjust one or more imaging parameters, a clarity and an exposure of one or more captured images when the user is capturing the data via an X-ray machine; an ability of the user to capture a clear image of a cervix and other relevant anatomical areas of the patient, to check a correct focus, a positioning, and illumination while capturing the clear image, a sharpness, a focus, and an image quality of the cervix and the other relevant anatomical areas of the patient in the clear image when the user is capturing the data via a colposcope;

[0045] a skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution image when the user is capturing the data via a dermatoscope.

[0046] Subsequent to processing of the data by the monitoring module 240, the evaluation module 245 may be configured to evaluate the at least one score assigned to the data with respect to the at least one parameter. The at least one score may be evaluated based on a predetermined threshold associated with the at least one parameter. For evaluating the at least one score, the evaluation module 245 may be configured to determine whether or not the at least one score associated with the at least one parameter is greater than the predetermined threshold for the at least one parameter.

[0047] Continuing with the above embodiment, the grading module 250 may be configured to assign one or more grades to the data based on the evaluation. The one or more grades may indicate the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices 105. The passing score and the failing score may correspond to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices 105 and the data captured by the user. For assigning the one or more grades, the grading module 250 may be configured to assign a weight to the at least one score. The weight may be assigned based on a significance of the at least one parameter with respect to the data and the one or more medical imaging and diagnostic devices 105 used for capturing the data. In an exemplary embodiment, where the data is captured by the ultrasound machine, the grading module 250 may be configured to assign a higher weight to the ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy. In another exemplary embodiment, where the data is captured by the user via the fundus imaging system, the grading module 250 may be configured to assign a higher weight to the ability of the user to capture the one or more high quality images of the at least one specific anatomical area with the clarity, the focus, and the anatomical accuracy. In another exemplary embodiment, where the data is captured via the spectroscopy system, the grading module 250 may be configured to assign a higher weight to the ability of the user to capture the one or more high quality spectra of at least one bio-fluid, and the signal quality obtained from the at least one bio-fluid. In another exemplary embodiment, where the data is captured by the ECG machine, the grading module 250 may be configured to assign a higher weight to one or more of the proper lead placement, the signal quality, the adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals. In another exemplary embodiment, where the data is captured by the X-ray machine, the grading module 250 may be configured to assign a higher weight to the ability of the user to position the patient correctly and adjust the one or more imaging parameters, the clarity, and the exposure of one or more captured images.

[0048] In another exemplary embodiment, where the data is captured by the colposcope, the grading module 250 may be configured to assign a higher weight to one or more of the ability of the user to capture the clear image of the cervix relative to the other relevant anatomical areas of the patient, to check the correct focus, the positioning and the illumination while capturing the clear image, the sharpness, the focus, and the image quality of the cervix and the other relevant anatomical areas of the patient in the clear image. In another exemplary embodiment, where the data is captured by the dermatoscope, the grading module 250 may be configured to assign a higher weight to one or more the skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution images.

[0049] Moving forward, the communication module 235 may be configured to transmit the one or more grades to one or more personnel. Examples of the one or more personnel may include, but are not limited to, the user, a supervisor, and an administrator. Furthermore, the training module 255 may be configured to suggest a personalized training module 255 to the user based on the one or more grades. The display module 260 may be configured to generate a user interface configured to allow an access of performance data comprising the at least one score against the predetermined threshold, the one or more grades, and a personalized training module 255 to one or more personnel. The user interface may include a dashboard configured for each party involved, that is, for users, supervisors, and administrators. In particular, the supervisors and administrators may be able to monitor the user proficiency and the one or more grades in the form of progress charts displayed on the user interface, and provide retraining recommendations. The progress chart may also include grades of each quality characteristic (e.g., image focus, brightness, positioning) for a given input such as the data at periodic timepoints relative to one or more initial grades. The passing or failing of the user in capturing the data with the predefined quality level may also be indicated on the user interface. The user interface may also allow for a human input in an assessment- training cycle driven by algorithms.

[0050] In one embodiment, the monitoring module 240 may be configured to determine that a performance of the user with respect to capturing the data with the predefined quality level is below a predetermined threshold value. The training module 255 may be configured to trigger a retraining of the user based upon the determination. The retraining may automatically be generated and customized with respect to the performance of the user. The retraining may be modified by a supervisor.

[0051] Moving forward, the display module 260 may be configured to generate another user interface presenting one or more questions to the patient seeking feedback. The patient may provide one or more responses for the one or more questions as feedback. The one or more questions may be presented to determine whether the patient is satisfied with a handling of the one or more medical imaging and diagnostic devices 105 by the user. Specifically, the one or more questions may be presented to capture a perspective of the patient on an encounter of the patient with respect to a number of parameters. Examples of the number of parameters may include, but are not limited to, proactive access, empathetic communication, active involvement, coordinated care, education and self-management, and quality and safety. The proactive access may be related to an ease of getting an appointment, wait times, and tele- / in-person options. The proactive access may measure an ability to offer timely slots, a use of virtual platforms and a triage efficiency. The empathetic communication may relate to the patient being satisfied and feeling heard by the user, a respectful tone of the user, and clear explanations from the user. Specifically, the empathetic communication may evaluate a use of plain language by the user while communicating with the patient and an active listening by the user. The active involvement may relate to an inclusion of the patient in decision-making, an encouragement to ask questions by the patient to the user. The active involvement may be used to evaluate a shared-decision making, eliciting preferences, and documenting consent. The coordinated care may be related to one or more follow-up plans between the patient and the user, one or more referrals, and information hand-offs. The coordinated care may be used to evaluate an interdisciplinary communication between the patient and the user, and a documentation completeness. The education and self-management may be related to a receipt of actionable instructions, one or more resources, and one or more goal settings. The education and self-management may evaluate teaching skills, and a quality of written / online materials provided by the user. The quality and safety may be related to a confidence with respect to the care provided by the user to the patient being safe, evidence-based, and respectful of patient privacy. The quality and safety may be used to evaluate an adherence to guidelines by the user, one or more error-prevention practices, and privacy safeguards. Table 1 indicates a number of potential questions including the one or more potential questions and a corresponding domain associated with the number of potential questions. The one or more responses by the patient may be one or more of grades ranging between 1-5, and one or more textual responses in an elaborated form.

[0052]

[0053]

[0054] Table 1 indicates a number of potential questions to be presented for a patient.

[0055] corresponding domains and a scale

[0056] Continuing with the above embodiment, the display module 260 may also be configured to generate yet another user interface presenting one or more potential user specific questions to the user. The one or more potential user specific questions may be presented after each instance of the user operating the one or more medical imaging and diagnostic devices 105. The one or more potential user specific questions may be presented for the user to reflect on an encounter with the patient. The one or more potential user specific questions may be answered by the user by selecting an option from a scale ranging between 1 and 5 for each potential user specific question. The user may provide “1” as a response to indicate that the user strongly disagrees with a statement asked to the user in a form of the one or more potential user specific questions, hi one embodiment, the user may provide “2” as a response that indicates that the user disagrees with the statement asked to the user in the form of the one or more potential user specific questions. In one embodiment, the user may provide “3” as a response that indicates that the user neither agrees nor disagrees with the statement asked to the user in the form of the one or more potential user specific questions. In one embodiment, the user may provide “4” as a response indicating that the user agrees with the statement asked to the user in the form of the one or more potential user specific questions. In another embodiment, the user may provide “5” as a response to indicate that the user strongly agrees with the statement asked to the user in the form of the one or more potential user specific questions. In another embodiment, where the statement does not apply to the instance of the user operating the one or more medical imaging and diagnostic devices, the user may select an option of “N / A”. The user may also be provided with one or more open ended potential questions that are optional but highly encouraged to be answered in the textual form. Table 2 below indicates a number of potential statements being asked as the one or more potential user specific questions, a corresponding domain amongst the number of domains for each statement, and a scale between 1-5 from which the user may select a value to answer the one or more potential user specific questions. The one or more responses from the user and the patient may be monitored by the CQA system 100.

[0057]

[0058]

[0059]

[0060]

[0061] Table 2 indicates a number of potential user specific questions to be presented for a user, corresponding domains and a scale

[0062] Further, the one or more responses ranging between the scale 1-5 may be reported. The reporting may be performed after a processing of the one or more responses. The processing may include a data cleaning, a reliability check, a composite score calculation, a benchmarking, actionable insights. The data cleaning may include converting “N / A” response to missing values. For each respondent (patient or a user), a domain-level mean (e.g., average of P1-P2 for Proactive Access) may be computed. Further, the reliability check may include calculating a Cronbach’s a for each domain (target > 0.80). The composite score may indicate an over-all satisfaction and may be a mean of items P13-P15 (or P14-P15 for providers). The benchmarking may include comparing domain means to a historical baseline of a clinic or to a regional benchmark (e.g., national PEACE-Q mean = 4.2). The actionable insights may include prioritizing domains with mean < 3.5 for quality -improvement work, and reviewing open-ended responses for recurring themes.

[0063] Further, the reporting may include producing a one-page dashboard which may be displayed on a user interface of the display module 260. The one-page dashboard may include a radar chart of the six domains (patient & provider side-by-side), a trend line for overall score over a predetermined period of time, which may be 12 months, top three patient verbatim comments and top three provider verbatim comments, and one or more recommended QI actions (e.g., “Develop a one -page after-visit summary” if Education score < 3.8).

[0064] In one embodiment of the present subject matter, the CQA system 100 may be communicating with an emulator via one of the wired communication standard and the wireless communication standard. The emulator may be configured to be used by the user prior to operating the one or more medical imaging and diagnostic devices 105. The user may train on the emulator prior to operating the one or more medical imaging and diagnostic devices 105 so as to be trained to accurately operate the one or more medical imaging and diagnostic devices 105 while examining the patient. In an embodiment, the monitoring module 240 may be configured to monitor the user emulating operating the one or more medical imaging and diagnostic devices 105 on the emulator. The monitoring module 240 may also be configured to grade the user based on a performance of the user while handling the emulator. Further, the user may be able to operate the one or more medical imaging and diagnostic devices 105 if the user is graded above a predetermined threshold. In an embodiment, where it is determined that the user is graded below the predetermined threshold, the user may be required to re-train on the emulator. The grade provided to the user may be used as a baseline for the user operating the one or more medical imaging and diagnostic devices 105.

[0065] FIG. 3 is a flow diagram elaborating a process of assessing a user proficiency in operating one or more medical imaging and diagnostic devices 105 and data captured by the user, according to some embodiments, including the following steps:

[0066] According to some embodiments, the process may include receiving, by the communication module 235 of the CQA system 100 an input on a User Interface (UI) from a user (3005). The input may be the data captured by the user via the one or more medical imaging and diagnostic devices 105. Examples of the one or more medical imaging and diagnostic devices 105 may include, but are not limited to, an ultrasound machine, an Electrocardiogram (ECG) system, a colposcope, a dermatoscope, a fundus imaging system, a spectroscopy system, an X-ray machine, and a microscope used to support cytology and histopathology. Upon receipt of the data by the communication module 235, the process may include processing the data in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data by the monitoring module 240 (3010). Examples of the number of parameters may include, but are not limited to:

[0067] ■ an ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy, when the user is capturing the data via an ultrasound machine;

[0068] ■ an ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy, when the user is capturing the data via a fundus imaging system; an ability of the user to capture one or more high quality spectra of at least one bio-fluid, and a signal quality obtained from the at least one biofluid when the user is capturing the data via a spectroscopy system; a proper lead placement, a signal quality, and an adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals when the user is capturing the data via an ECG machine;

[0069] an ability of the user to position a patient correctly and adjust one or more imaging parameters, a clarity and an exposure of one or more captured images when the user is capturing the data via an X-ray machine; an ability of the user to capture a clear image of a cervix and other relevant anatomical areas of the patient, to check a correct focus, a positioning, and illumination while capturing the clear image, a sharpness, a focus, and an image quality of the cervix and the other relevant anatomical areas of the patient in the clear image when the user is capturing the data via a colposcope;

[0070] a skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution image when the user is capturing the data via a dermatoscope. Upon processing of the data, the process may include evaluating by the evaluation module 245 the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter (3015). Evaluating the data may include determining whether or not the at least one score associated with the at least one parameter is greater than the predetermined threshold for the at least one parameter.

[0071] Upon the evaluation of the data by the evaluation module 245, the process may include assigning one or more grades by the grading module 250 to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices 105 (3020). The passing score and the failing score may correspond to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices 105 and the data captured by the user. Furthermore, the process may include transmitting by the communication module 235 the one or more grades to one or more personnel (3025). Examples of the one or more personnel may include, but are not limited to, the user, a supervisor, and an administrator. The process may include suggesting by the training module 255 a personalized training module to the user based on the one or more grades (3030). Subsequently, the data captured by the user may be continuously evaluated in a similar manner. Subsequent to grading of the data, a performance of the user in capturing the data may be continuously monitored. To that understanding, a progress chart disclosing the one or more grades for the data received at a number of periodic timepoints relative to one or more initial grades may also be displayed along with performance data comprising the at least one score against the predetermined threshold, the one or more grades, a consolidated grade associated with any of the one or more medical imaging and diagnostic devices, and a personalized training module for the user. The progress chart disclosing the one or more grades may be made available to one or more personnel. Furthermore, a summary chart may also be displayed for the one or more personnel disclosing a relative performance for one or more users using the one or more medical imaging and diagnostic devices.

[0072] FIG. 4 illustrates an architectural diagram depicting an assessment of a user proficiency in operating one or more medical imaging and diagnostic devices 105 and data captured by the user, according to some embodiments. The architectural diagram may include the CQA system 100 communicating with the one or more medical imaging and diagnostic devices 105 as referred in the FIG. 1.

[0073] The CQA system 100 may be configured to receive the data captured by the user via the one or more medical imaging and diagnostic devices 105. Examples of the one or more medical imaging and diagnostic devices 105 may include, but are not limited to, an ultrasound machine, an Electrocardiogram (ECG) system, a colposcope, a dermatoscope, a fundus imaging system, a spectroscopy system, an X-ray machine, and a microscope used to support cytology and histopathology. Continuing with the above embodiment, the monitoring module 240 may be configured to process the data to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data. Examples of the number of parameters may include, but are not limited to: an ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy, when the user is capturing the data via an ultrasound machine;

[0074] an ability of the user to capture one or more high quality images of at least one specific anatomical area with a clarity, a focus, and an anatomical accuracy, when the user is capturing the data via a fundus imaging system;

[0075] an ability of the user to capture one or more high quality spectra of at least one bio-fluid, and a signal quality obtained from the at least one bio-fluid when the user is capturing the data via a spectroscopy system; a proper lead placement, a signal quality, and an adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals when the user is capturing the data via an ECG machine;

[0076] an ability of the user to position a patient correctly and adjust one or more imaging parameters, a clarity and an exposure of one or more captured images when the user is capturing the data via an X-ray machine;

[0077] an ability of the user to capture a clear image of a cervix and other relevant anatomical areas of the patient, to check a correct focus, a positioning, and illumination while capturing the clear image, a sharpness, a focus, and an image quality of the cervix and the other relevant anatomical areas of the patient in the clear image when the user is capturing the data via a colposcope;

[0078] ■ a skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution image when the user is capturing the data via a dermatoscope.

[0079] Subsequently, the evaluation module 245 may be configured to evaluate the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter. The evaluation module 245 may include a number of algorithms to evaluate the at least one score. The at least one score may then be used by the grading module 250 to assign one or more grades to the data. The one or more grades may indicate the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices 105. The passing score and the failing score may correspond to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices 105 and the data captured by the user. From this, an overall grade may be determined for the data. When carried out for a first time by the user, the above steps may be used to determine the user proficiency in capturing the data. The user proficiency may indicate one of a passing or a failing of the user in capturing the data against a predefined quality level. Subsequently, the data captured by the user may be continuously evaluated in a similar manner. Subsequent to grading of the data, a performance of the user in capturing the data may be continuously monitored. To that understanding, a progress chart disclosing the one or more grades for the data received at a number of periodic timepoints relative to one or more initial grades may also be displayed along with performance data comprising the at least one score against the predetermined threshold, the one or more grades, and a personalized training module to one or more personnel.

[0080] Furthermore, the training module 255 may be configured to suggest a personalized training module to the user based on the one or more grades. To that understanding, in one embodiment, the monitoring module 240 may be configured to determine that a performance of the user with respect to capturing the data with the predefined quality level is below a predetermined threshold value. The training module 255 may be configured to trigger a retraining of the user based upon the determination. The retraining may automatically be generated and customized with respect to the performance of the user. The retraining may be modified by a supervisor upon being presented.

[0081] FIG. 5a is an image of a user interface depicting a login screen for a user of the medical imaging and diagnostic devices 105, according to some embodiments. The user may be required to be authenticated prior to being allowed to use one or more of the medical imaging and diagnostic devices 105, system 100 and an emulator. The authentication may be performed based on an electronic e-mail Identity (ID) and a password associated with the user. The user may enter the e-mail ID and the password on the login screen to seek access to data related to one or more patients in the system 100 or the emulator. FIG. 5b is an image of a user interface depicting a patient management screen, according to some embodiments. The patient management screen may be accessed by the user to manage data of the one or more patients. The data may be related to the one or more medical imaging and diagnostic devices 105 as referred to in FIG. 1.

[0082] FIG. 5c is an image of a user interface depicting a procedure screen presented to the user while the user is capturing the data via the one or more medical imaging and diagnostic devices 105, according to some embodiments. The procedure screen may display a number of options for the user to select while capturing the data. Examples of the number of options may include, but are not limited to, change / adjust focus mode, adjust LED intensity, adjust zoom level, capture image, close / quit procedure, and navigate to next step of procedure.

[0083] FIG. 6 is a flow diagram of a method for assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by the user, according to some embodiments. The method includes the steps of:

[0084] ■ receiving, by a communication module, the data captured by a user via the one or more medical imaging and diagnostic devices as an input (6005);

[0085] ■ processing, by a monitoring module, the data in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data (6010);

[0086] ■ evaluating, by an evaluation module, the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter (6015); and

[0087] ■ assigning, by a grading module, one or more grades to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices, wherein the passing score and the failing score corresponds to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices and the data captured by the user (6020).

[0088] In the description and claims of the present application, each of the verbs, “comprise”, “include”, and “have”, and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb. Unless otherwise stated, adjectives such as “substantially” and “about” modifying a condition or relationship characteristic of a feature or features of an embodiment of the disclosure, are understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of an embodiment as described. In addition, the word “or” is considered to be the inclusive “or” rather than the exclusive or, and indicates at least one of, or any combination of items it conjoins.

[0089] Descriptions of embodiments of the invention in the present application are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments. Some embodiments utilize only some of the features or possible combinations of the features. Variations of embodiments of the invention that are described, and embodiments comprising different combinations of features noted in the described embodiments, will occur to a person having ordinary skill in the art. The scope of the invention is limited only by the claims. Unless explicitly stated, the method embodiments described herein are not constrained to a particular order in time or chronological sequence. Additionally, some of the described method elements may be skipped, or they may be repeated, during a sequence of operations of a method.

[0090] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents may occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0091] Various embodiments have been presented. Each of these embodiments may of course include features from other embodiments presented, and embodiments not specifically described may include various features described herein.

Claims

CLAIMS1. A Continuous Quality Assessment (CQA) system for assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by a user, the CQA system comprising:a communication module configured to receive the data captured by the user via the one or more medical imaging and diagnostic devices as an input;a monitoring module configured to process the data in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data;an evaluation module configured to evaluate the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter; anda grading module configured to assign one or more grades to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices, wherein the passing score and the failing score corresponds to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices and the data captured by the user.

2. The system according to claim 1, wherein the one or more medical imaging and diagnostic devices is selected from a group consisting of an ultrasound machine, an Electrocardiogram (ECG) system, a colposcope, a dermatoscope, a fundus imaging system, a spectroscopy system, an X-ray machine and a microscope used to support cytology and histopathology.

3. The system according to claim 1, wherein the plurality of parameters comprises: a. an ability of the user to capture one or more high quality images of at least one specific anatomical area, when the user is capturing the data via an ultrasound machine;b. an ability of the user to capture one or more high quality images of at least one specific anatomical area, when the user is capturing the data via a fundus imaging system;c. an ability of the user to capture one or more high quality spectra of at least one bio-fluid, and a signal quality obtained from the at least one bio-fluid when the user is capturing the data via a spectroscopy system:d. a proper lead placement, a signal quality, an adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals when the user is capturing the data via an ECG machine:e. an ability of the user to position a patient correctly and adjust one or more imaging parameters, a clarity and an exposure of one or more captured images when the user is capturing the data via an X-ray machine;f. an ability of the user to capture a clear image of a cervix relative to other relevant anatomical areas of the patient, to check a correct focus, a positioning, and illumination while capturing the clear image, a sharpness, a focus, and an image quality of the cervix and the other relevant anatomical areas of the patient in the clear image when the user is capturing the data via a colposcope;g. a skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution images when the user is capturing the data via a dermatoscope.

4. The system according to claim 3, wherein the one or more high quality images of the at least one specific anatomical area captured by the ultrasound machine and the fundus imaging system is with a clarity, a focus, and an anatomical accuracy.

5. The system according to claim 1, wherein the evaluation module is configured to evaluate the at least one score by:determining whether or not the at least one score associated with the at least one parameter is greater than the predetermined threshold for the at least one parameter.

6. The system according to claim 1, wherein the grading module is configured to assign the one or more grades by:assigning a weight to the at least one score, wherein the weight is assigned based on a significance of the at least one parameter with respect to the data and the one or more medical imaging and diagnostic devices used for capturing the data.

7. The system according to claim 1, further comprising:the communication module configured to transmit the one or more grades to one or more personnel.

8. The system according to claim 7, wherein the one or more personnel is selected from a group consisting of: the user, a supervisor, and an administrator.

9. The system according to claim 1, further comprising:a training module configured to suggest a personalized training module to the user based on the one or more grades.

10. The system according to claim 1, further comprising:the monitoring module configured to determine that a performance of the user with respect to capturing the data with the predefined quality level is below a predetermined threshold value; andthe training module configured to trigger a retraining of the user based upon the determination, wherein the retraining is automatically generated and customized with respect to the performance of the user.

11. The system according to claim 1, further comprising:a display module configured to generate:a user interface configured to allow an access of performance data comprising the at least one score against the predetermined threshold, the one or more grades, a personalized training module to one or more personnel, and one or more previous grades assigned to previous data associated with the one or more medical imaging and diagnostic devices12. The system according to claim 1, further comprising:the display module configured to:present one or more questions and one or more user specific questions on the user interface separately post the operating of the one or more medical imaging and diagnostic devices: andreceive one or more responses corresponding to the one or more questions from a patient and one or more responses corresponding to the one or more user specific questions from the user as feedback.

13. A method for assessing a user proficiency in operating one or more medical imaging and diagnostic devices and data captured by a user, the method comprising:receiving, by a communication module, the data captured by the user via the one or more medical imaging and diagnostic devices as an input;processing, by a monitoring module, the data in order to assign at least one score with respect to at least one parameter amongst a plurality of parameters to the data;evaluating, by an evaluation module, the at least one score assigned to the data with respect to the at least one parameter based on a predetermined threshold associated with the at least one parameter; andassigning, by a grading module, one or more grades to the data based on the evaluation, indicating the at least one score as one of a passing score and a failing score of the data associated with the one or more medical imaging and diagnostic devices, wherein the passing score and the failing score corresponds to an assessment of the user proficiency in operating the one or more medical imaging and diagnostic devices and the data captured by the user.

14. The method according to claim 13, wherein the one or more medical imaging and diagnostic devices is selected from a group consisting of an ultrasound machine, an Electrocardiogram (ECG) system, a colposcope, a dermatoscope, a fundus imaging system, a spectroscopy system, an X-ray machine, and a microscope used to support cytology and histopathology.

15. The method according to claim 13, wherein the plurality of parameters comprises; a. an ability of the user to capture one or more high quality images of at least one specific anatomical area, when the user is capturing the data via an ultrasound machine;b. an ability of the user to capture one or more high quality images of at least one specific anatomical area, when the user is capturing the data via a fundus imaging system;c. an ability of the user to capture one or more high quality spectra of at least one bio-fluid, and a signal quality obtained from the at least one bio-fluid when the user is capturing the data via a spectroscopy system;d. a proper lead placement, a signal quality, an adherence of the user to one or more ECG protocols, a quality of heart signals, and a minimal noise interference in the heart signals when the user is capturing the data via an ECG machine;e. an ability of the user to position a patient correctly and adjust one or more imaging parameters, a clarity and an exposure of one or more captured images when the user is capturing the data via an X-ray machine;f. an ability of the user to capture a clear image of a cervix relative to other relevant anatomical areas of the patient, to check a correct focus, a positioning, and illumination while capturing the clear image, a sharpness, a focus, and an image quality of the cervix and the other relevant anatomical areas of the patient in the clear image when the user is capturing the data via a colposcope; andg. a skill of the user to capture a plurality of high resolution images of skin lesions, an accurate representation of one or more critical diagnostic features in the plurality of high resolution images, a resolution, a clarity, and whether one or more key diagnostic features of skin lesions is represented accurately in a plurality of high resolution images when the user is capturing the data via a dermatoscope.

16. The method according to claim 15, wherein the one or more high quality images of the at least one specific anatomical area captured by the ultrasound machine and the fundus imaging system is with a clarity, a focus, and an anatomical accuracy.

17. The method according to claim 13, wherein evaluating the data comprises:determining, by the evaluation module, whether or not the at least one score associated with the at least one parameter is greater than the predetermined threshold for the at least one parameter.

18. The method according to claim 13, wherein assigning the one or more grades comprises:assigning a weight to the at least one score, wherein the weight is assigned based on a significance of the at least one parameter with respect to the data and the one or more medical imaging and diagnostic devices used for capturing the data.

19. The method according to claim 13, further comprising:transmitting, by the communication module, the grade to one or more personnel.

20. The method according to claim 19, wherein the one or more personnel is selected from a group consisting of: the user, a supervisor, and an administrator.

21. The method according to claim 13, further comprising:suggesting, by a training module, a personalized training module to the user based on the grade.

22. The method according to claim 13, further comprising:determining, by the monitoring module, that a performance of the user with respect to capturing the data with the predefined quality level is below a predetermined threshold value; andtriggering, by the training module, a retraining of the user based upon the determination, wherein the retraining is automatically generated and customized with respect to the performance of the user.

23. The method according to claim 13, further comprising:generating, by a display module, a user interface configured to allow an access of performance data comprising the grade, and a personalized training module to one or more personnel.

24. The method according to claim 13, further comprising:presenting, by the display module, one or more questions and one or more user specific questions on the user interface separately post the operating of the one or more medical imaging and diagnostic devices; andreceiving, by the display module, one or more responses corresponding to the one or more questions from a patient and one or more responses corresponding to the one or more user specific questions from the user as feedback.

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