Quture embeds HFACS in QualOptima as an integral classification and causation nanocodes system. QualOptima is available to healthcare providers to integrate quality management, risk management and credentialing on its unified database with analytics technology as Quture’s innovative and transformative Value Data Center. QualOptima is an extraordinary experiential learning platform, designed for organizational, clinician and patient learning to achieve optimal outcomes.
One use of QualOptima is to reduce medical errors and transform patient safety processes. Quture offers medical malpractice insurers and healthcare organization self-insured trusts the capability to:
- learn from errors based on aggregated data;
- embed proven intervention strategies into optimal clinical processes;
- calculate, track and report accurate adverse events data;
- coordinate risk management and insurer claims management processes;
- devise and implement healthcare provider disclosures with patients;
- report (transparent) errors as regulators’ requirements evolve;
- manage claims and defense settlements and trials, and
- achieve better measurement and data-driven decisions for granting clinical practitioner privileges based on current clinical competence, exceeding FPPE-OPPE standards.
Quture offers a structured and expert empowered five (5) step process to learn, and incorporate lessons learned, from medical errors, focused on preventable errors, from adverse events using the Human Factors Analysis & Classification System (HFACS) of Drs. Shapell and Wiegmann. The goal of Quture’s QualOptima informatics platform to solve the medical errors epidemic is the 5th stage summarized graphically below.
The preceding section to this whitepaper discusses how we can learn about medical errors from medical malpractice claims. This section explores how Quture contracts to consult and implement our QualOptima informatics platform in medical malpractice and healthcare risk management.
Drs. Shappell and Wiegmann’s experiences indicate that HFACS can be prospectively applied in health care, is effective at identifying both human and system errors, and lends itself particularly well to the systematic categorization of errors across events. They also have vast experience with analysis of archival databases and retrospective review of such adverse event data. They have found that HFACS could not be retrospectively applied to previous RCAs because of three (3) factors:
- Appropriate questions sometimes had not been asked to identify specific behavioral causes of the adverse event.
- It was not possible to retrospectively determine if additional causal factors may have been involved that were not explored in the original RCA.
- The higher level tiers (i.e., organizational influences, supervision) typically were not emphasized in the previous RCA methodology.
In view of these conclusions, the ultimate goal of Quture is illustrated above, so that HFACS is applied uniformly as the classification and RCA system prospectively and in collaboration to learn from medical malpractice allegations, facts, and causation determinations across the boundaries of insurance claims management and insured risk management.
Drs. Wiegmann and Shappell have further incorporated concepts from the National Safety Foundation (NPSF) to perform root cause analysis.[i] Despite the emphasis of the NPSF on system errors rather than human errors, there are useful tools in RCA² incorporated into their HFACS software system, especially for HFIX.
Quture’s five (5) phase process to accomplish to learn from medical malpractice claims is illustrated below. The advantages of analyzing retrospective archival data despite the limitations. Using archival data is an excellent opportunity to examine gaps during adverse event investigation analysis using HFACS, which become evident when explored during the training phases. Experience has shown that introducing the system during training provides insight into questions that must be asked, considered and answered in HFACS application.
QualOptima for medical malpractice claims management and amelioration, for proactive clinical risk management, is provided in the settings for insurers, whether commercial (including reinsurance) and self-insured trusts, and providers, including hospitals, systems (especially self-insured hospital systems), and physician groups. Health insurance carriers are also logical customer segments but are not illustrated in the diagrams (slight modifications).
Phase 1: HFACS Training & Process Installation
Basic training in HFACS begins to introduce the system as a process with its methodology to learn fundamental concepts. The HFACS four (4) levels of failure and the causation nanocodes are taught by the Founders of HFACS, so the system and five (5) phased implementation are introduced. Examples of sentinel claims from the organization are used after standard training examples have been considered.
Initial training begins to focus on how events are identified and classified in HFACS. From this initial introduction to HFACS, begin with the end in mind will consider the ultimate collaborative processes of investigating and analysis of causation in a unified database. Root cause analysis (RCA) and failure mode and effects analysis (FMEA) are briefly considered in the context of HFACS analysis and the QualOptima system to continuously develop optimal clinical processes, including maximized patient safety.
Phase 2: Analysis Archived Claims Database
Despite the limitations discussed above using HFACS retrospectively in archived databases, there are two (2) primary benefits from examining medical malpractice claims databases. First, learning application of HFACS for claims managers and processors gives insight into the factors (expressed as nanocodes or exemplars) in each element of the four (4) levels of failure. Hands on learning provides high level understanding and insight into the gaps which may exist in investigated claims.
Second, the ultimate goal in Phase 5 is to evolve from single case review to use of the aggregated Qualytx unified database for medical malpractice in the QualOptima informatics platform. Phase 2 introduces aggregate data analysis for prevention strategies, using HFIX, to prevent medical errors or to intervene when they occur. This is ultimately the beginning basis of a unified, comprehensive, reliable database of medical error claims and liability exposures.
A study[i] by Vicki-lynne Gloger is good example of learning from reported errors. Expert consultants will use HFACS to evaluate and develop this baseline database from insurance claims files. This phase is exponentially more valuable if individual insured risk management data is independently evaluated and developed for this baseline.
Phase 3: Install & Train QualOptima HFACS Informatics Platform
QualOptima with the HFACS application is installed with training in use of the software during Phase 3. Nanocodes are provided in a library for selection and potentially customization, and these advance considerations begin during Phase 2. The Qualytx aggregated database exists when installed, so that training includes analysis of aggregated data, as well as single case entry, investigation and analysis.
Causation analysis (including RCA), including HFIX, is also provided with introduction to software for use in both aggregate and single case use of QualOptima HFACS. Use of FMEA software for development of optimal clinical processes is available during Phase 3, as well.
Phase 4: Claims & Case Coordination/Collaboration
QualOptima is designed primarily as a connectivity and analytics platform for experiential learning. Coordination and collaboration between the insurer or self-insured trust, for opening and managing claims throughout the linear progression of each claim, is instructed and implemented in Phase 4 for participating providers.
Aggregate data analysis for prioritization of identified interventions is provided with the software functionality. Consultation and training on this functionality, along with single case data and investigation processes, are included during this phase. QualOptima as an experiential learning platform for pattern and trend analysis, focused on search and analytics, is trained and developed. Optimal clinical processes, including patient safety interventions, are the goal of this training phase for holding the gains in Phase 5.
Phase 5: Implementation
The progression through Phases 1 through 4 are designed to achieve the ultimate goals diagrammed for Phase 5 implementation.
The completed process results in the Human Factors framework for classification, then analysis, becoming the system empowered by technology by both, and between, medical malpractice insurers / self-insured trusts and health care providers as insureds. Coordination and collaboration begins at data entry for single case workflow, with both using the same HFACS processes. HFACS will become the investigation and analytics system, so causation is evaluated not only in a common fault and relative fault process, but pattern analysis from aggregated data can enable disciplined intervention and prevention strategies.
Costs of legal counsel and insurance administrative costs are discussed in the Section detailing the financial and economic consequences of medical malpractice insurance and litigation. The Quture HFACS coordination and collaboration between insurers and insureds will decrease the costs while making their processes more effective and efficient.
The ultimate goal of QualOptima HFACS is to reduce preventable medical errors, make patients more safe while simultaneously providing improved care and outcomes. The result will contemporaneously reduce the massive costs of these errors, and the loss of human life and suffering, both in the context of care and claims.
Defendants & Legal Theories:
Hospitals and physicians, as defendants in medical malpractice litigation, frequently have competing interests. The allegations and legal theories against them may include pleadings to even position one against the other. It is not uncommon for plaintiffs to sue hospitals, even though the facts and basis for the claim may be more obscure, because it is different suing a bricks and mortar, wealthy hospital with an executive at defense table than a physician taken from the patients who rely upon him or her. In most jurisdictions, the jury will not be allowed to know if there is insurance to pay a verdict; so a personal judgment is very different from the hospital corporation.
Quture believes that the new Joint Commission standards create new and serious liability exposures to hospitals for negligently credentialing doctors. This will be discussed separately; however, HFACS involves organizational and supervisory factors as two (2) of the four (4) levels of failure. Organizational influences include culture, processes and resource management. Inadequate supervision and planned inappropriate operations are key exposures for hospitals. Failure to correct known problems is a fundamental concern in hospitals, where financially lucrative routine practices, such as overuse and complication patterns may increasingly provide liability exposures. For physicians, the distinction between routine violations and exceptional violations (willful disregard to rules) is very significant in the context of unsafe acts. Whereas, administration knowledge of routine disregard of reasonably prudent practices is an example of lining up the holes in the Swiss cheese model.
Preconditions for unsafe acts impose another level of potential failures, where the hospital, responsible for nursing and other employee factors and physical factors, such as design of physical facilities (e.g., operating rooms) are within the prevue of the hospital rather than the physician. These are just 30,000 foot examples of negligence in the context of human error.
Medical Errors and Negligence Legal Concepts:
Medical malpractice operates within its own set of rules, which are in some instances very different from human factors. One of the best ways to consider these differences is within the context of Unsafe Acts. Clearly, willful disregard for rules, delineated in HFACS as Violations, is contextually different than negligence in civil litigation.
Negligence, as a legal concept, if poorly understood and frequently misstated by those who do not excel in tort litigation. For example, the WHO definition of negligence, in the meticulous listing of precise definitions, presents the legal concept of negligence as violations of the “standard of care.” The legal definition of negligence, for physicians as well as other professionals and lay defendants is actually very simple and straightforward: what would a reasonably prudent person do under the same or similar circumstances?
An example of this distinction occurred in Quture’s experience many years ago in a Federal Tort Claims Act when the wife of an Army master sergeant was misdiagnosed as having inoperable and therefore fatal adenocarcinoma of the stomach. She was discovered over a year later, because she had survived without clinical explanation, to have a stomach ulcer. The expert witness against the VA hospital gave his written opinion that the defendant was culpable for incorrect diagnosis of adenocarcinoma based on pathology slides of tissue removed from the patient’s stomach surgically.
The government sent a JAG lawyer to take a statement from the expert under oath. The witness was former chairman of pathology at the University of Colorado School of Medicine and practicing pathology as chief at a major hospital in Colorado Springs. The plaintiff’s attorney, poorly prepared and foolish, went straight to the heart of the case, the ultimate issue, and asked: “was the defendant negligent in this case?” The pathologist thought for a very long time and then responded: “No.” Everyone freaked out and the JAG officer was ready to pounce and celebrate. I asked for a couple of minutes with plaintiff counsel and the witness in private to adequately prepare the attorney with a logical sequence of questions:
- Would a reasonably prudent pathologist, based on review of the tissue slides of the submitted patient’s stomach tissue, have diagnosed adenocarcinoma? To this question, his answer was “no, that would not be prudent, and is not what a competent pathologist would report.”
- Based on your review of the tissue slides in this case, what action would a reasonably prudent pathologist have undertaken? To this question, his answer was “the pathologist would logically communicate with the surgeon and document in his report that more tissue would be required from a larger sample to make a definitive analysis and pathological diagnosis.”
- What would a reasonably prudent pathologist state as the diagnosis of this patient’s condition? The pathologist answered: “You would only call that ‘suspicious’ of adenocarcinoma, never stating adenocarcinoma as the definitive diagnosis.”
- What injury occurred to the patient based on your examination of the medical records in this case? “She was told she had inoperable cancer of the stomach and had no more than 6 months to live.”
- After she survived for several years and another physician evaluated her, with repeat surgery, tissue removal and pathological examination, what was the correct diagnosis in this case? “She had a painful stomach ulcer.”
The difference in understanding definitions and working with medical experts and evidence is the difference between winning and losing medical malpractice cases. The federal judge, who eventually ruled on this case and had been a practicing malpractice defense attorney before taking the bench commented in his ruling that this was the most dramatic malpractice case he had ever seen before awarding the largest FTCA verdict in U.S. history. Understanding definitions like “negligence,” how optimal clinical processes are evidence of “standard of care,” and “reasonably prudent physician,” crafting questions and knowing enough medicine to prepare evidence is the difference in hundreds of thousands and millions of dollars.
The facts of this case were that upon initial request for the tissue slides for examination by a plaintiff’s expert pathologist, the VA hospital stated in a sworn document that the slides for this patient had been “lost.” Quture knew that the military keeps a duplicate set of slides for patients with cancer diagnoses in Washington, D.C., at the Armed Forces Institute of Medicine (AFIP). The government was surprised and alarmed to learn that with a subpoena to AFIP, the slides were photographed at AFIP. Of the 73 slides with tissue samples, one slide, because of the way the cells appeared clustered like grapes, looked like adenocarcinoma. The other 72 slides did not. So the master sergeant’s wife resigned from nursing, told her children and husband, bought her funeral outfit for the casket, and waited to die taking morphine for the pain (which made the ulcer worse) until an astute resident wondered how she could still be alive.
At the individual physician level of HFACS analysis, is this a skill-based error by the pathologist? Or was it a decision error? The facts are definitive that this was an unsafe act, with no evidence of any violation.
Between the surgeon and pathologist, were there errors of communication and/or coordination of care?
What if any was the liability of a hospital if this event had occurred in a public hospital rather than the VA? Were there any errors at the level of Supervisory Influences or Organizational Influences – or both? Considering the facts of the “lost” slides to hide the error from a military dependent in the VA system, who committed the willful disregard of the rules?
The example above is related only to a physician, not the hospital. The two (2) levels of failure that relate to Unsafe Acts and Preconditions for Unsafe Acts are errors that occurred at both levels. The James Reason and “Swiss cheese” model assume that significant errors occur when they happen at all four (4) levels. This case is also an example of diagnostic errors, the most common medical errors, as discussed in the Section Diagnostic Medical Errors. But how will risk managers, insurance claims managers, and attorneys handle one of the most prevalent reasons of the drastic differences in variance in America. An example of the impacts of readmissions and rates of clinical variance and payment disincentives are discussed in Section Financial & Economic Consequences of Medical Errors.
The other example of multiple levels of medical errors and relationships of liability (in law these are considered within the context of joint and several liability and for damages apportionment of fault and harm impacts) in this section involves overuse of medical services (within the framework of overuse, underuse and misuse).
The medical staff of a major hospital in a large system of hospitals engaged Quture in our third major external peer review project in Indiana. The hospital and its self-insured trust had major concerns regarding an orthopaedic surgeon who had practiced at the hospital for over 20 years and was believed by them to have a very large practice. Their concerns were around repeat surgeries, especially on knee and hip joints, asking why new prosthetic devices were so frequently changed but with very few clear medical errors that harmed patients. This assignment was pivotal in the evolution of Quture’s eventual software product, since it was where we first develop standardized quality of care question sets.
The single case that ultimately led to the medical staff expressing their concerns to hospital administrators involved the death of a patient who received an elective knee replacement surgery. Reviewed as a single case, the Unsafe Act was to operate on a patient with too few platelets to clot after surgery and having serious complications. Analyzed in the continuum of care, considering previous repeat surgeries on this patient, what was most alarming was that one year prior, she almost died from an elective hip surgery, again with too few platelets (thrombocytopenia). She was hospitalized for several months after the hip surgery for bleeding and infections, so to again risk her life for an elective knee implant was clearly an error classified as a Decision Error at the Unsafe Acts level of failure.
But pattern analysis across the spectrum of his patients revealed that he had a relatively small practice, just enough patients to bring back for surgery of one type or another every year. Despite relatively high Skill-Based performance, with statically insignificant complication rates, the question in the HFACS framework would have been over in the Violations nanocodes. Poor medical judgement involving financial considerations led to not only overuse of medical services but willful Violations of prudent medical care, overuse for financial gains at the risk of patients.
Over the period of 20+ years, had the hospital examined the care of this surgeon in the HFACS framework for re-credentialing every two )2) years, this fatal medical error would not have occurred. In the Just Culture Model of consoling, coaching and punishing for reckless behaviors, re-credentialing and corrective action processes would have resulted in either changing these behaviors or termination of the surgeon’s medical staff membership and privileges (which ultimately occurred after the analyses of this Quture engagement).
When Quture consults and provides resources and information technology with the QualOptima v1.7 Value Data Center platform, prevention of negligent credentialing and patient safety to prevent medical errors is the goal of the product and services.
Investigation and analysis of medical malpractice claims in the HFACS framework are extraordinary valuable, both from the perspective of the case as a single claim and in the aggregate at both the insurance and provider levels. Millions of dollars can be saved and tens, if not hundreds of thousands of medical errors can be prevented by the QualOptima HFACS coordination & collaboration model.
 Marx D, Patient Safety and the “Just Culture”: A Primer for Health Care Executives (New York, NY, Columbia University, 2001).
[i] Gloger V, “Prevention of medical errors: root causes and strategies to avoid errors,” Northeast Florida Medicine 64(1): 39-44 (2013).
[i] National Patient Safety Foundation, RCA²: Improving Root Cause Analyses and Actions to Prevent Harm, Version 2, January 2016 (Boston, MA).