Medical mistake mitigation using disruptive information technology

I remind my employees that though rapid change may seem troubling and scary, it's the only way forward. We must render ourselves obsolete in a way, and try a new way of doing things.

After all, this internal growth and change mirrors our entire industry, where we're constantly reminded that our healthcare system is broken. We must find a better way to drive down costs and deliver better care. Our clients are also navigating new territory, and we must be willing to be teachers and learners with them, working as one, to make healthcare work as it should.1

We agree heartily with the foregoing statement by Jonathan Bush, Cofounder, CEO and President of athenahealth, particularly as it applies to medical mistake mitigation and consequent avoidance of nosocomial/iatrogenic patient morbidity and mortality. According to a peer-reviewed study published in the September, 2013, edition of the Journal of Patient Safety, "... the true number of premature deaths associated with preventable harm to [hospitalized] patients was estimated at more than 400,000 per year ... [and] [s]erious harm seems to be 10- to 20-fold more common than lethal harm."2 Research shows that human failures cause 80% to 90% of errors3, and "In health care, close calls or incidents manifest when processes do not match or support the known human cognitive and physical limitations and capabilities."4

In light of these facts, The Joint Commission has prioritized the topic of patient safety5 by defining and reporting on patient safety sentinel events, setting standards for patient safety systems in the context of its healthcare delivery organization accreditation manual, and providing guidance in root cause and human factor analysis. In addition, the Joint Commission Center for Healthcare Transformation creates and promulgates methods and tools (e.g. – Robust Process Improvement® or RPI®, a healthcare-specific application of Lean/Six-Sigma methodologies 6) to highlight the critical need for high reliability in healthcare delivery. However, although "Human factors analysis (also referred to as human factors engineering) is an essential step to designing equipment, procedures, tasks, and work environments because research shows that human failures cause 80% to 90% of errors,"7 neither The Joint Commission nor the organizational healthcare providers that it accredits have appreciated fully or have addressed successfully the need for continuous/real-time and comprehensive support for the human cognitive limitations that cause medical errors and consequent patient safety events (PSEs, a.k.a. patient adverse events or PAEs).

Even the National Patient Safety Foundation in its most recent comprehensive report places more emphasis directly or indirectly on human factors, addressing IT only in the last of its eight recommendations more of a patient safety threat than a facilitator: "Ensure that [information] technology is safe and optimized to improve patient safety."8 Obviously, this recommendation presumes healthcare IT as it currently is predominantly manifest in the hard-coded logic and database input-/output-oriented electronic health records (EHRs), a.k.a. hospital information systems (HISs). These systems feature drop-down data selection windows and a programmed series of process steps implemented on hardware systems installed on client healthcare provider premises. Considered collectively, the IT systems designed ostensibly to address human factors/failures tend to complicate them; and, ironically, current manual/document-based mistake mitigation tactics tend instead to exacerbate human cognitive capability overload or to minimize clinical complexity wherein lies the potential for medical discovery and improvement. As an example of cognitive overload, training in refined process particulars exposed by RPI or similar methodologies require more precise and comprehensive recall and immediate decision in the complex process plethora which is the healthcare delivery environment. As an example of oversimplification, tactics that are employed to simplify problematic processes and therefore to increase the probability of repeatable accuracy and timeliness tend to diminish clinical effectiveness (e.g. – the CDC 150-page CLABSI mitigation guidelines reduced to a five-point checklist developed by The Armstrong Institute 9). What, then, can be done to mitigate medical mistakes and thereby reduce significantly the intolerable quantity of PSEs/PAEs?

The answer, as implied in the introductory quote by Mr. Bush and represented in part by his company's current EHR offering as a cloud implementation, is healthcare-focused "disruptive IT" defined as follows: an intelligent business process management suite (iBPMS) including IT "middleware" such as business process, business rules, complex event, analytics, connectivity and mobile device management; implemented in an Internet-accessible commercial data center (a.k.a. the cloud) operated by a cloud service provider (CSP); made available via a secure (software-defined networking and encryption technologies) Internet portal for use by healthcare provider subject matter experts (SMEs) on a subscription basis using non-programmer/-developer tools (e.g. – drag-and-drop, rules definition selection, natural language) with minimal need for IT professional support, thereby minimizing cost and complexity. SMEs would design, develop and deploy automated use cases heretofore deemed impossible to implement because of human cognitive limitations or infeasible because of the complexities of IT middleware configuration and utilization. Such use cases include continuous ICU bedside monitor data stream analysis and condition-/clinician-specific notification to mitigate alarm/alert fatigue, real-time differential diagnosis development to minimize clinician decision bias and memory limitation resulting in misdiagnosis, hospital case constant monitoring and staff notification to avoid communication errors at shift hand-off and room transfer and consequent PAEs. Even an application such as that developed in a hard-coded manner recently at the Armstrong Institute could be implemented using a cloud-based intelligent business process management suite (CiBPMS):

The foundation of Project Emerge is a tablet application that coordinates and integrates all data from all monitoring equipment and information systems. Rather than scavenge medical records, devices and other sources to ensure patients receive all the appropriate care, clinicians can use the tablet app to quickly see all data in one location. The tablet app also updates continuously a "harms monitor," a simple diagram tracking hundreds of tasks for each patient separated into seven sections. The harms monitor tracks which preventative tasks were performed and alerts to situations when patients may be at risk. Using a simple color chart, the app quickly shows clinicians the status of actions that need to be taken on a regular basis to prevent harm: red for current actions, yellow for upcoming and green for complete.11

Use case automation, accomplished principally by healthcare provider SMEs using a CiBPMS, minimizes the need for transfer of often detailed healthcare provider knowledge to IT professionals, with reduced inefficiency and errors. Also avoided are IT staff and system costs and operational loads, typically with much-improved security that CSPs ensure. In addition, CiBPMS-developed applications supplement the provider-installed HIS/EHR and other disparate legacy systems and applications by leveraging their many features such as best-of-breed application functionality and databases, integration with installed systems and devices, and staff user expertise; all achieved by means of included connectivity and data transformation/transmission features. A cloud-based iBPMS offers the promise of medical practice and healthcare delivery transformation by providing tools for provider SMEs to create continuous cognitive support anywhere and anytime via a mobile or any other Internet-connectible digital device. Thereby, increased use of a CiBPMS by healthcare providers, particularly if specified in revised Patient Safety System standards of The Joint Commission 12, will serve to mitigate medical mistakes, minimize PAEs/PSEs, optimize clinical case outcomes, and accelerate advancement of medicine by broadening the "bridge from bench to bedside" through continuous coordination of system-staff actors and the automated development and sharing of process-based knowledge.

The following case study of a fatal PAE/PSE, described in an article entitled "Human Factors Analysis in Patient Safety Systems" appearing in a recent edition of a publication of The Joint Commission, provides a typical opportunity for patient safety optimization using a CiBPMS.

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. Although the organization had conducted a thorough RCA, The Joint Commission asked it to revise the RCA and consider human factors issues that led to the event and implement more strategies that incorporate human factors solutions, which would more reliably prevent the event from occurring again.13

The process described in this patient fatality case study, re which The Joint Commission requested the organization to "implement more strategies that incorporate human factors," is depicted in Figure 1.

Figure 1 – "As Is" Manual/EHR-Supported Patient Monitoring Process

Figure 1


Alternatively, in the hopefully near-future world of healthcare provider IT middleware appreciation and application, The Joint Commission's recommendation (rather than request, and with reference to an appropriately augmented Patient Safety Systems accreditation standard) to the reporting healthcare organization would be for it to create or to refine the subject process using a CiBPMS to address the deficiencies discovered using RCA, resulting in fatality avoidance and morbidity limitation owing to constant monitoring of order execution status. In the near-future world, the actions to be taken for reliable medical mistake mitigation and PSE/PAE avoidance would use the CiBPMS "4-D" methodology:

1. Healthcare provider SMEs use CiBPMS tools to design the required process collaboratively, including event and device monitoring parameters and threshold values, activity actor and action details, rule and decision specifications, and connectivity to installed EHR and other systems.

2. SMEs use CiBPMS tools with minimal IT staff support to develop process (i.e. – create a run-time version) with no changes to currently installed IT systems, applications and IT staffing; but instead leveraging installed system functionality and data sources using intelligent connectivity.

3. SMEs cooperate with IT staff to deploy processes as needed, to be activated automatically per prescribed conditions/events (e.g. – physiological parameter values meet pre-defined abnormal criteria) or manually per staff-initiated conditions (e.g. – patient admission).

4. SMEs use CiBPMS process management functionality (e.g. – key performance indicator a.k.a. KPI monitoring) with no IT staff involvement to decide and redesign process changes for continuous process improvement (CPI), incorporating learning from previous version run-time experience.

5. CiBPMS enables automatic vesting of procedure steps and CPI-acquired knowledge to ensure reliably repetitive process design and execution with minimal cognitive impact on process actors.
The CiBPMS-enabled process to mitigate the deficiencies of the case study and therefore to avoid patient deterioration and death is depicted in Figure 2.

Figure 2 – "To-Be" CiBPMS/CHART-created Patient Monitoring Process

Figure 2

Medical mistake mitigation and consequent reduction in iatrogenic/nosocomial fatalities and other patient adverse events requires use of Cloud-based intelligent business process management suites – disruptive information technology for positive transformation of medical practice and healthcare delivery.

N.B. – The authors and other Directors and Professional Advisory Board members of CHARTSaaS.org, a U.S. IRS 501(c)(3) corporation, seek funding to deploy the Cloud Healthcare Appliance Real-Time (CHART) solution as a service for subscription use by licensed/accredited healthcare providers (re www.chartsaas.org).

https://www.beckershospitalreview.com/hospital-management-administration/jonathan-bush-retreating-toward-a-purpose.html, accessed 3/18/2016.

http://journals.lww.com/journalpatientsafety/fulltext/2013/09000/a_new,_evidence_based_estimate_of_patient_harms.2.aspx

3 US Department of Defense. Department of Defense Human Factors Analysis and Classification System: A Mishap Investigation and Data Analysis Tool. Jan 11, 2005. accessed 3/10/2015, http://www.uscg.mil/safety/docs/pdf/hfacs.pdf

4 The Joint Commission, The Source, Human Factors Analysis in Patient Safety Systems, XIII:4, April, 2015, p. 7, http://www.jointcommission.org/assets/1/6/HumanFactorsThe_Source.pdf

http://www.jointcommission.org/topics/patient_safety.aspx

http://www.centerfortransforminghealthcare.org/about/rpi.aspx

7 The Joint Commission, op. cit., http://www.jointcommission.org/assets/1/6/HumanFactorsThe_Source.pdf

http://www.npsf.org/?freefromharm, accessed 3/18/2016.

9 Video at http://bit.ly/1UbphWf, accessed 3/18/2016.

10 Gartner, https://www.gartner.com/doc/reprints?id=1-2BYYFBE&ct=150319&st=sb&elqaid=896&elqat=2&elqTrackId=664384b2119a4628b31126e195625b64

11 http://www.hopkinsmedicine.org/armstrong_institute/improvement_projects/project_emerge.html

12 http://www.jointcommission.org/patient_safety_systems_chapter_for_the_hospital_program/, accessed 3/20/2016

13 The Joint Commission, The Source, Human Factors Analysis in Patient Safety Systems, XIII:4, April, 2015, p. 1

The views, opinions and positions expressed within these guest posts are those of the author alone and do not represent those of Becker's Hospital Review/Becker's Healthcare. The accuracy, completeness and validity of any statements made within this article are not guaranteed. We accept no liability for any errors, omissions or representations. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with them.​

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