The document proposes a cloud-based healthcare solution called CHARTSaaS that would provide healthcare providers with a software development environment to easily create customized cognitive support apps. This would help address the root cause of many medical mistakes, which is that cognitive demands in healthcare exceed providers' capacities. The solution would be accessible via a web portal and allow non-technical providers to build apps for tasks like decision-making, case management, and handoff communications. The goal is to transform healthcare delivery through mitigating mistakes, optimizing outcomes, and accelerating knowledge application and accrual.
Hello 2018 World Summit on Healthcare and Hospital Management attendees. My name is Pete Melrose, an independent information technology or IT consultant to healthcare providers doing business as CHARTSaaS, LLC. I appreciate this opportunity to present for your consideration and, hopefully, your support, the Cloud Healthcare Appliance Real-Time Solution as a Service, a copyrighted IT solution for the positive transformation of medical practice and healthcare delivery.
This is the first of eight slides that depict the principle “problems” inherent in the practice of medicine and delivery of healthcare. This slide depicts the problem of multi-dimensional scope. Notwithstanding the fact that current healthcare is more correctly described as health cure – that is, the return of the morbid patient to a nominal if not normal bio-physio-psychologically status – healthcare should be defined to include the maintenance of good health. Therefore, this schematic depicts four healthcare spectra, beginning with the womb-to-tomb or conception-to-death duration of a human individual, punctuated by episodes of injury or illness requiring medical intervention, and/or by episodes of in-patient hospital-based care and treatment. Ideally, the information that accrues during the patient subjective and objective data collection a.k.a. the history and physical workup, the differential and final diagnosis, and the case assessment and treatment plan all should be archived in the common body of medical knowledge in a manner that is readily accessible for application to the next clinical case that presents.
The second provider problem is the triple focus of care and treatment. Medical practice and healthcare delivery require an in-depth knowledge of the presenting patient (comprehended by the provider distinctly and separately among the several other patients currently in treatment), the patient’s presenting pathology or even comorbidities, and also the principal provider’s care team members (including their individual capabilities, as they relate to the presenting patient and pathology).
The third provider problem is the need for time-critical actions. Not only must medical practice and healthcare delivery actions be done completely and accurately but also in a timely manner, and timeliness is required for the intended effects of actions taken in both the micro- or internal and the macro or external environments to be obtained. Internally, human homeostasis occurs continually; driven by microbiological mechanisms that control inputs and internal conditions in order to maintain a nominal biophysiological state of equilibrium. Externally, in the visible world, conditions and circumstances change constantly too; which changes must be detected and reacted to in time to minimize morbidity. Both these dimensions of timeliness require constant monitoring, to detect changing conditions in time to maintain nominal conditions or to prevent unintentional conditions and crises.
The fourth medical practice and healthcare delivery problem is that of intensive information. Medical and healthcare information typically is intense with respect to volume, variety, velocity and varying veracity. Given these extremes of amount, type, speed and accuracy; it is impossible for the human mind to execute the four activities of the information processing cycle depicted here with required completeness, accuracy and timeliness performed continuously:
First, to acquire information through constant monitoring and complex event analysis;
second, to assess information through similarity searches and predictive analysis;
third, to apply information through decision-making and process execution; and
fourth, to adapt information through results analysis and process improvement.
The fifth medical practice and healthcare delivery problem is that of chaotic venues. For example, these two photographs depict the potential cause-and-effect nature of clinical chaos. In the upper-left photo, one nurse is taking report from another nurse that is possibly erroneous or incomplete, because some other clinicians (as highlighted by the red box) are conversing in the same space in a probably audible and therefore distracting manner. As highlighted in the lower-right photo, the hurried and complicated venue may lead to communication using familiar but unreliable and error-prone means such as written notes rather than more reliable means such as the electronic health record data readily available via the computer terminal in close proximity, as highlighted again by the red box).
The sixth medical practice and healthcare delivery problem is uncontrolled experiments. Patient care and treatment is in fact a scientific exercise conducted using the scientific method -- beginning with the history and physical workup leading to problem identification and a diagnostic hypothesis following from a differential diagnosis for a complicated presentation and leading to care and treatment that is more or less experimental, depending on the clinician’s familiarity with the presenting problem and timeliness of pathology resolution. However, the clinical case may in fact represent two or more concurrent experiments that are interactive if comorbidity is involved; and the one or more concurrent experiments are conducted under largely uncontrolled conditions in a non-laboratory setting. Also, experimental continuity and timeliness will be complicated if one pathology such as Type II Diabetes is well-understood and therefore subject to a sequential course of treatment; but another pathology such as an infrequently occurring malignancy is unfamiliar and therefore necessarily subject to an iterative course in treatment as new diagnoses are developed and different treatment plans executed.
The seventh medical practice and healthcare delivery problem is electronic health record or EHR systems. The problematic aspects encountered are summarized by the survey results shown in this slide: efficiency improvement impediments, 42%; no significant decrease in workload, 72%; and increased operating costs, 54%. These disappointing results to date, following more than three decades of operational experience, are not surprising; given that EHR systems are designed primarily as systems of record with revenue management and maximization as their principal design goals. The necessary improvement in IT-enabled data management will be realized only by systems of engagement that facilitate real-time process management and improvement.
The eighth medical practice and healthcare delivery problem is cognitive impediments. Patrick Coskerry, MD, in his 2009 article entitled Clinical cognition and diagnostic error: applications of a dual process model of reasoning identifies several cognitive impediments that affect us all, but that are exacerbated in clinicians because of the nature of their work and their typical working conditions. These include what he labels as high decision density, interruptions or distractions, circadian dys-synchronicity (that is, interruption of biological daily cycles leading to uncoordinated/conflicting psychological and physiological states within a daily time period), fatigue or sleep deprivation, and emotional perturbations (also known as affective state disturbance). Regarding sleep deprivation, it is significant to note that cognitive decision-making tends to reach its nadir at 3-4am; and some studies equate cognitive performance at that time of night, with legal intoxication.
Source: Croskerry P. Clinical cognition and diagnostic error: applications of a dual process model of reasoning. Adv Health Sci Educ Theory Pract. 2009;14 Suppl 1:27-35. https://first10em.com/2015/09/15/cognitive-errors/
Because of the eight practice problems we have just reviewed, the preponderant symptom of current medical practice and healthcare delivery is the frequent and life-threatening occurrence of medical mistakes. Medical error can take several forms: an unintended action (either of omission or commission), an action that does not achieve its intended outcome, the failure of a planned action to be completed as intended (an error of execution), the application of a wrong plan to achieve an aim (an error of planning), or a deviation from a standard of care process that may or may not cause harm to the patient. Currently in the United States, medical mistakes are the third leading cause of patient deaths following cancer and heart disease; numbering from one quarter million to almost one-half million deaths annually, depending on the study cited. This is an almost five-fold increase during the two decades since the USA Institute of Medicine report entitled “To err is human” was published. As of last year, medical mistakes now account for 45% of the cost of healthcare in the USA – approximately 1.44 trillion with a “T” dollars annually! There is no mitigating end in sight for several reasons: there is no International Classification of Diseases or ICD code for errors or human/system factors, morbidity and mortality committee minutes are subject to legal discovery, malpractice claim settlements routinely include gag orders, and there is no uniform and mandatory investigative process such as that followed by the USA National Transportation Safety Board for public transport accident investigations.
James Broselow, MD, a retired pediatrician, invented the eBroselow app for pediatric medication dosing calculation and administration verification. Dr. Broselow states a principal caution in medical practice and healthcare delivery to minimize the cognitive demands leading to medical mistakes: that memory and mathematics must be avoided to ensure correct care. However, practitioners traditionally have ignored this advice, probably because it has seemed not to be feasible.
Lawrence Weed, MD, a recently deceased American physician, researcher, educator, entrepreneur and author of long standing, who is best known for creating the problem-oriented medical record as well as one of the first electronic health record systems, states in his 2017 book entitled Medicine in Denial, coauthored with his son Lincoln, that “A culture of denial subverts the health care system from its foundation. The foundation—the basis for deciding what care each patient individually needs— is connecting patient data to medical knowledge. That foundation, and the processes of care resting upon it, are built by the fallible minds of physicians. A new, secure foundation requires two elements external to the human mind: electronic information tools and standards of care for managing clinical information.”
Substantiated by the foregoing empirical and therefore authoritative observations of Drs. Broselow and Weed, I have arrived at my own conclusion about medical mistake root cause. Based on over four decades of work experience and observations in hospitals and other healthcare venues, and also relevant reading including peer reviewed studies regarding medical mistake root cause analysis or RCA, I postulate that clinical cognitive demands exceeding significantly the cognitive capacity of humans in general and clinicians in particular creates the real root cause of medical mistakes – cognitive overload.
Notwithstanding what I have just posited as the root cause of medical mistakes – cognitive overload – all currently operating medical mistake mitigation and patient safety organizations of which I am aware continue to focus on human factors such as the culture of safety, use of heuristics to aid memorization, and protocol and procedure training for performance improvement. These are cognitive-based tactics that necessarily exacerbate the cognitive overload root cause of medical mistakes, so their occurrence persists at an unacceptably high frequency. The human factors and heuristics foci are perpetuated by such organizations as the long-standing National Patient Safety Foundation, now merged as of May, 2017, with the longer standing Institute for Healthcare Improvement, educational ventures such as the Safety & Quality Informatics and Leadership Program at Harvard Medical School, academic medical center-based initiatives such as the Armstrong Institute for Patient Safety and Quality at Johns Hopkins Medicine, and more recently formed foundations for goal setting and healthcare provider and medical technology vendor collaboration such as the Patient Safety Movement Foundation. The persistent emphasis on human factors, heuristics and process training is problematic, as typified by the need to resolve cognitive conflicts such as checklist brevity with the acceleration of medical knowledge accrual that exposes more and more complicated knowledge for migration from bench to bedside. This approach cannot effect significant progress in medical mistake mitigation – a new approach is needed.
The preceding facts, conclusions and observations lead us to this proclamation:
Whereas
medical & healthcare practices & procedures are critical & complicated & constantly operating, and
medical & healthcare venues are extraordinarily varied, dispersed & chaotic, and
human cognitive capabilities are exceeded by medical practice & healthcare delivery demands;
Therefore, healthcare provider SMES require
customized real-time and mobile apps; and
an easy-to-use software development environment create them directly with minimal IT staff support
Given cognitive overload as the root cause of medical mistakes, and the medical mistakes as the third leading cause of patient deaths in the USA, my vision for the much-needed IT-enabled medical practice and healthcare delivery transformative solution is encapsulated in the acronym of the copyrighted solution name – Cloud Healthcare Appliance Real-Time, which is intended to be a functional and dynamic supplement to the structural and static patient chart as summarized by its acronym:
Cloud –
portal-accessible solution-as-a-service
Healthcare –
designed for healthcare providers
Appliance –
to create custom cognitive support apps
Real-Time –
that operate anywhere and constantly
CHART can realize these elements as identified by its acronym because it is implemented as a “solution as a service” or SaaS, a term which refers to programmed functionality running at a cloud datacenter and accessible via an Internet portal, much like any of the familiar retail sales, banking and other commercial websites.
To meet the demonstrated need for a real-time IT-enabled information management solution, CHARTSaaS satisfies the requirements shown on this slide.
functional requirements: referring to the non-IT healthcare provider SME’s need for an easy-to-use software development environment (SDE) to create mobile device IT applications a.k.a. “apps”
non-functional requirements for the SDE & the apps that it creates, including:
ubiquitous – accessible anywhere & any time
secure – protected code and data access, transmission/operation & storage
reliable – that is, non-stop & no-fault operation
scalable – dynamically allocates and deallocates system resources for acceptable response times
economical – usage-sensitive subscription billing
This information technology or IT architecture schematic depicts the several components of the CHARTSaaS solution and their principal purposes. In general, the non-functional requirements including reliability, security per HIPAA regulations, and scalability are satisfied by the selected cloud service provider or CSP services enclosed in green. The CSP-managed Internet-accessible data center also provides services for secure connection to other Internet-attached sources and devices commonly referred to as the Internet of Things or IoT depicted in red. The functional requirements, provided by components enclosed in blue, include the cloud-based CHARTSaaS SDE that itself includes services for interoperability with the CHARTSaaS Subscriber’s on-premise IT systems and data sources such as its EHR system. Using the CHARTSaaS SDE, the Subscriber’s authorized users create applications that can be uploaded to an app store ready for use and downloaded to run in users mobile devices, all as shown in red.
To enable the healthcare provider SME to create cognitive support mobile apps, the CHARTSaaS SDE includes eight features:
subscriber/user & artifact administration –
rules-based/Boolean decision description –
process & case management description –
data/device Interoperability description –
Bayesian/multi-variate analytics description –
mobile device administration/management –
knowledge archiving & access management –
operations management & optimization –
Access to the Cloud Healthcare Appliance Real-Time Solution as a Service or “CHARTSaaS” software development environment requires a four-step procedure:
a prospective CHARTSaaS Subscriber completes the registration form at chartsaas.com and submits it electronically;
the prospective Subscriber receives an email of approval and acceptance including disclaimers, some instructions and login credentials;
the now-approved Subscriber surfs to the charsaas.com sandbox page and logs in; and
the Subscriber views the SDE desktop and clicks on a feature icon to begin app development work.
This slide depicts the screens used for describing a process, at upper left, and also a case, at lower right. The process design tool implements the familiar swim lane flowchart paradigm, in this case to describe a failure to rescue mitigation process; and the case description screen implements the folder paradigm to aggregate discontinuous but related processes that include unpredictable human interventions and/or wait times, as would be the case with an health insurance claim. For process and case management, decision management and various process administrative and optimization features and functions, CHARTSaaS will capitalize on the free and open source software or FOSS developed by the Camunda corporation, founded in Germany in 2008, having websites at C-A-M-U-N-D-A dot com and also dot org. The Camunda software suite is available in the FOSS Community Edition for free use and incorporation in other software solutions by independent firms; or in the commercial Enterprise Edition. EE includes, for a use-dependent price, a more full-function feature set for technical operations and also for support, maintenance and training services. Camunda implements a three-click method for migration from design-time diagrams such as those shown on this slide and the next to run-time code, without the need for IT expert support; which implements for the most part the main value proposition of CHARTSaaS: an easy-to-use software tool for healthcare subject matter experts to create cognitive support apps with minimal cost and complexity. This method is predicated on the internationally recognized Object Management Group’s BPMN, CMMN and DMN modeling notation standards.
This slide depicts the screen used for describing a multi-condition and action decision, also incorporating the applicable OMG standard DMN as implemented in FOSS software from Camunda. The two-dimensional table format includes rows that each define a decision parameter by name; the threshold, normal or other critical value against which the decision input value is to be evaluated; and the one or more actions to be executed depending on the evaluation. For example, this approach is adequate to monitor a diabetic patient’s A1C level for inclusion in a process to notify the healthcare provider and the patient regarding insulin regulation. Alternatively, required actions could be defined in named columns, in order to include several parameter value evaluations; as would be needed to monitor relevant physiological parameters to detect and prevent a septic patient’s progression to severe sepsis or septic shock.
This slide depicts the sources for a screen to be developed for describing the interoperability between a CHARTSaaS process activities and the sources of the data required to execute the processes. The long-standing HL-7 connectivity standard for transfer of clinical and administrative data between software applications used by healthcare providers has been extended in recent years to include Fast Healthcare Information Resources or FHIR. This specification, as described at its website “.. leverages existing logical and theoretical models to provide a consistent, easy to implement, and rigorous mechanism for exchanging data between healthcare applications … [with] … built-in mechanisms for traceability to the HL7 Records and Information Management or RIM standard and other important content models … ” FHIR defines logical resources that “… satisfy the majority of common use cases …” Recently, major EHR vendors such as Epic and athenaHealth have begun implementing libraries of application programming interfaces or APIs that enable access to their healthcare provider customers’ EHR systems to obtain and provide information without risk of corruption to the stored data or code. The CHARTSaaS SDE will leverage both of these facilities to enable connectivity and interoperability between SDE-built apps, the CHARTSaaS Subscriber’s EHR system and other Internet-accessible data sources.
This slide depicts a screen that defines and provides access to several mobility related parameter and value definition screens including authorized users, location, processes to be included, devices or operating systems such as Android or iOS to be targeted and permitted access to “back end” systems such as the Subscriber’s EHR system. The software to implement mobile device features has yet to be determined. This also is the case for the Bayesian/multi-variate capability for similarity and predictive analytics, both of which are central to automation of use cases such as differential diagnosis and treatment planning.
Speaking of use cases – that is, candidates for automation using the CHARTSaaS SDE – there exist a virtually infinite number. Most include one of four persistent sub-processes that recur frequently in medical practice and healthcare delivery, that exceed human cognitive capability and that therefore lead to patient morbidity and mortality: 1) failure to rescue (FtR) – patient preventable death owing to a clinical complication not recognized in a timely manner or treated appropriately; 2) constant monitoring – observation of patient, disease, condition or one/medical parameters over time; 30 alarm/alert fatigue – desensitization to alarms/alerts owing to exposure to high number of frequent alarms; 4) hand-off communication (HoC) – transition of care & patient-specific information by one healthcare professional to another.
A fatal example of a HoC was reported to The Joint Commission as a so-called “sentinel event” per the TJC accreditation requirements and published in the April, 2015, issue of a TJC publication named The Source as follows: “A health care system submitted a root cause analysis (RCA) to The Joint Commission for a sentinel event that involved a patient whose blood levels were not drawn frequently enough to monitor the thinness of her blood while receiving a continuous heparin infusion. The patient had been started on a heparin infusion on an orthopedic unit and then was later transferred to a cardiac unit. The order set for the heparin infusion was not entered properly, leaving out the automatic order for blood tests every 6 hours. During the handoff report, the nurses did not discuss when the next blood test would occur to monitor the heparin infusion. For 24 hours, the patient went without blood tests until an oncoming nurse questioned the situation during the handoff report. At this time, the off-going nurse also reported that the patient had been complaining of a headache for several hours. A computerized tomography (CT) scan showed intracerebral hemorrhage. When the patient’s mental status deteriorated, the family chose not to proceed with surgery due to the patient’s multiple comorbidities and recent decrease in quality of life. She expired three days later.”
Hand-off communication errors are the leading cause of medical mistakes, and therefore they must be mitigated to effect a significant reduction in instances of patient morbidity and mortality overall. Because the HoC process has risen to the level of “sentinel event” in the eyes of The Joint Commission, but with no TJC recommended mitigation tactics other than attention to human factors and heuristics (which as we have seen merely exacerbates the cognitive overload root cause of medical mistakes), it is potentially the most productive example for demonstrating the value of a real-time cognitive support app created using the CHARTSaaS SDE. This slide depicts a fatal hand-off communications sentinel event using the swim-lane flowchart paradigm with five rows to depict the activity of the five actors: the patient, the healthcare physician provider, nursing staff on the post-operative orthopedic nursing unit 1, nursing staff on the receiving cardiac nursing unit 2 and the electronic health record IT system. Also included are seven columns to depict the five events included by the beginning and ending of process flow.
This slide employs the swim lane flowchart paradigm again to depict the sentinel event previously described, as it would have occurred with a CHARTSaaS HOC app in operation, the app being depicted in the added swim lane at the bottom of the flowchart enclosed in green. The app operates continuously and is designed to monitor the occurrence and content of updates to the EHR patient record and to report problematic events. In this case, the app would deduce that the required blood Type 1 heparin-induced thrombocytopenia or Type 1 HIT test had not been performed within the six-hour time interval since the previous test, because the app did not detect the occurrence of an update to the patient’s EHR case record Type 1 HIT test result data field. Therefore, the app would notify the implicated clinical staff member or members via their associated mobile and/or other digital devices of the emergent need to perform the ordered test and to read the result. Thereby, the medical error of omission would have been avoided; and the patient’s life, saved!
This slide includes representations of the three Hand-off Communications app screens: the left-hand image, designed for patient or nursing unit designation; the center image, if the user designates a nursing unit, for automatic display of the current patient roster on the designated unit, from which the user can select a patient; and the right-hand image, for display of the selected patient’s pertinent data which in this case are organized according to the Situation, Background, Assessment and Recommendations or SBAR heuristic. Data pertinent to the monitoring of potential Type 1 HIT, the values of which are approaching lethal limits, and/or urgent actions to be taken are displayed in red. As you can see, the CHARTSaaS Software Development Environment enables healthcare provider subject matter experts to create customized, cost-effective and potentially life-saving apps such as Hand-off Communications. These apps are created and operated with minimal operating expense, no capital cost, minimal IT complexity and little or no impact on the CHARTSaaS Subscriber healthcare provider organization’s IT system and staff resources; all because of the cloud-based portal and subscription modalities of operation.
I very much appreciate your valuable time and attention to consider the Cloud Healthcare Appliance Real-Time Solution as a Service, the CHARTSaaS purpose and scope, and its transformative potential. Please contact me via email or phone at your earliest convenience to discuss and decide how you may participate in realizing this disruptive IT solution for the positive transformation of medical practice and healthcare delivery. Thanks again, and good wishes for another great day!