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Quture International

Learning from Medical Malpractice Claims (HFACS,Part 8):

Martin Makary, in his recent article[1] “Medical error—the third leading cause of death in the US.”  He begins with his observations: “The science of safety has matured to describe how communication breakdowns, diagnostic errors, poor judgment, and inadequate skill can directly result in patient harm and death.”

Dr. Makary’s perspectives of human factors in medical errors mirrors the positions of learning from errors and scientific approach of Quture.  He observes: “Human error is inevitable. Although we cannot eliminate human error, we can better measure the problem to design safer systems mitigating its frequency, visibility, and consequences.”

Quture advocates the strategy for hospitals to carry out a rapid and efficient independent investigation into deaths to determine the potential contribution of error, the very same words as Dr. Makary. He proposes a root cause analysis approach medico-legal protections to maintain anonymity would enable local earning while using. QualOptima HFCAS introduces a standardized data collection and reporting processes; such a standardized and common database is essential to an accurate national picture of the problem, its causes and solutions.

Healthcare Science

Healthcare Science

Optimal outcomes, clinical, operational and financial, depend upon creating a culture of learning from mistakes.   The Institute of Medicine’s goal of creating learning health systems depends upon advancing the science of safety.  Dr. Makary concludes his article stating: “To achieve more reliable health care systems, the science of improving safety should benefit from sharing data nationally and internationally, in the same way as clinicians share research and innovation about coronary artery disease, melanoma, and influenza. Sound scientific methods, beginning with an assessment of the problem, are critical to approaching any health threat to patients. The problem of medical error should not be exempt from this scientific approach. More appropriate recognition of the role of medical error in patient death could heighten awareness and guide both collaborations and capital investments in research and prevention.”

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HFACS  Model

HFACS Strategies and Processes in Health Care and Med Mal Insurance (Part 7):

HFACS provides new methods to restructure design of analysis of adverse events, accidents, human and system errors.  In real-time settings, like hospitals and intake of medical malpractice claims, this is retrospective but with a prospective component. In real-time, methods involve the following seven (7) steps:

  • Identification and reporting of events in single incidents (cases), whether near misses or adverse event;
  • Triage of single incidents AND those single cases in the context of aggregated data for prioritization of further actions;
  • Investigation of single incidents in the context of identifying opportunities to improve:
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Quture International

Other Human Factors Classification Systems (Part 6):

International Classification Systems

International Classification Systems

The preceding Section HFACS in Health Care Internationally discusses the work of Bill Runciman, M.D., in Australia and the international human factors classification systems in the patient safety endeavors of the World Health Organization (WHO) and the World Alliance for Patient Safety.  In the United States, others groups have developed their own human factors classification systems based on the initial James Reason concepts, but without the expertise from the extensive meta-analysis for development of HFACS by Drs. Shappell and Wiegmann.

While Dr. Shappell was a Commander in the United States Navy, reporting to the Admiral of the Atlantic Fleet, he was tasked to reduce an alarming rate of aviation accidents.  Working with his associate, Doug Wiegmann, Ph.D., who was then at the Pensacola Air Station, they conducted a meta-analysis of over 16,000 accidents involving U.S. Navy/Marine Corps (1990-98), U.S. Air Force (1991-97), U.S. Army (1992-98).  Their collaborative human factors meta-analysis led to what is now the Human Factors Analysis & Classification System (HFACS).  Dr. Shappell continues to conduct studies of both civil and military accidents as part of an ongoing project with NASA and the U.S. Navy/Marine Corps.  Previously, he served as Chief, Human Factors Branch US Naval Safety Center, then Head, Aeromedical Department US Naval Safety Center Reserve Unit (1999-2004).

Healthcare organizations, without human factors expertise, have developed a variety of unsuccessful systems characterized as patient safety human factors classification systems

and taxonomies.  methods have been used to analyze medical malpractice claims data.  Despite excellent endeavors to date, these methods have not significantly impacted preventable medical errors and reduced patient harm from those efforts.  The most obvious include:

  • Joint Commission Patient Safety Event Taxonomy (PSET);
  • CRICO (Risk Management Foundation affiliated with Harvard); and
  • MedStar Health, National Center for Human Factors in Healthcare.
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Quture International

HFACS in Health Care Internationally (Part 5):

There is a significant experience internationally with human factors classification and taxonomy systems in healthcare organizations and liability insurance claims.  These systems and processes date back to the 1990’s, so the evidence is that these have had little or no impact on the rate of preventable medical errors in the United States and most other countries globally.

The study from Dr. Makary of Johns Hopkins University Medical School estimated that medical error is the third biggest cause of death in the US and therefore requires greater attention. “Medical error leading to patient death is under-recognized in many other countries, including the UK[i] and Canada[ii].”  The study recognizes the inherent problem in existing systems, similar to Quture’s experiences, that the International Classification of Diseases (ICD) codes established for billing limit effectiveness of human factors analysis and classification.

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Financial & Economic Consequences of Medical Errors

Financial & Economic Consequences of Medical Errors (Part 4) :

The financial consequences to our society are equally devastating.  The financial cost impacts on the American economy ranges from conservative estimates of $19.5 billion to $980 billion.  These wide financial differences result from variations discussed above in the estimates of incidence of medical errors and economic factors used in the calculations of costs. This incredible 50 times difference should not diminish the remarkable financial cost to individuals, insurers and our government.  The differences are in what is counted, the formulas and definitions underpinning the math.

The landmark IOM report, To Err Is Human: Building a Safer Health System, originally calculated that preventable medical errors caused 44,000 to 98,0001 preventable deaths each year.[i] The associated cost was calculated ranging from $17 to $29 billion. The question is whether that number is now ten (10) times greater, with upward of 1 million per year, based on a study using the Institute for Healthcare Improvement’s (IHI) Global Trigger Tool.[ii]  This study is based on an extraordinarily small data sample from three (3) hospitals, and it made no attempt to examine which adverse events were or were not preventable (assuming all adverse events could be avoided with proper medical care).  The trigger tool study used a different definition for “harm”: “unintended physical injury resulting from or contributed to by medical care that requires additional monitoring, treatment, or hospitalization, or that results in death.”[iii]

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Example of the numers in the lierature.

HFACS and the Magnitude of the Medical Errors Epidemic (Part 3):

Example of TJC numers.

Example of TJC numbers.

The introduction to this white paper began with incidence of preventable medical errors from the 2016 report by patient safety experts at Johns Hopkins University Medical School.  This startling rate of 251,454 per year places preventable medical errors as are the third leading cause of death in America.  Medical error rates have ranged from a low of 44,000 to 17,090,615 medical errors per year.  Whether relying on this frequency or comparing it to another similar rate statistically calculated by a patient safety advocate whose literature review estimates 210,000 medical errors per year, all experts agree that the frequency is much greater.  Whether it is two (2) times, three (3) times or 10 times, the real number is actually much greater than 250,000 million.  Whether errors are preventable, the role of physicians in the processes of identification, root causes and solutions, how impacts are paid for as payment or malpractice compensation, the magnitude of these issues have been extensively studied.  However, no solutions to any of these challenges to date is even promising. The medical errors epidemic is unconscionable.

As Dr. Martin Makary observes in his recent report of the study with his research associate: “There are several possible strategies to estimate accurate national statistics for death due to medical error. Instead of simply requiring cause of death, death certificates could contain an extra field asking whether a preventable complication stemming from the patient’s medical care contributed to the death.”[i]

The conclusion of this report is extremely significant when the range of incidence rates of medical errors, and whether they are deemed “preventable,” is considered. “Sound scientific methods, beginning with an assessment of the problem, are critical to approaching any health threat to patients. The problem of medical error should not be exempt from this scientific approach. More appropriate recognition of the role of medical error in patient death could heighten awareness and guide both collaborations and capital investments in research and prevention.”

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HFACS for the Health Care Ecosystem (Part 2; Announcement, is 1st installment):


Figure 1. HFACS process for single case and application module of QualOptima® from Quture.

Quture’s HFACS technologies, whether for the stand-alone HFACS, Inc. application or embedded in QualOptima, is so much more than counting the frequency and rates of medical errors and preventable adverse events (PAEs).  Thorough review of the literature reveals that most funding for such events is to academicians for research.  Very little money has been spent to identify the root causes, even if there were uniform classification and FMEA (failure mode and events analysis) systems, and intervention solutions to solve these problems once identified and understood.

The study of human error in the workplace is not novel to health care. James Reason and others have suggested that errors occur at four (4) levels of failure adopted as the framework for HFACS:

  • Unsafe Acts—the actions of the operator;
  • Preconditions for Unsafe Acts—environmental factors contributing to the error;
  • Supervision—management actions affecting the operator; and
  • Organizational Influences—the culture, policies, and procedures of the organization that affect the operator.

According to Reason’s views, humans are inherently error prone and system processes often are affected by latent weaknesses. HFACS is a methodology developed by Wiegmann and Shappell[i] based in part upon James Reason’s “ Swiss cheese ”  model of accident causation.[ii]

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Quture (QUTR) Announces Agreement With HFACS, Inc. for New System to Solve the Healthcare Medical Errors Epidemic

Quture_LogoDAYTONA BEACH, FL–(Marketwired – Jun 2, 2016) – Quture International, Inc. (OTCQB: QUTR) (“Q”) the proven and experienced clinical performance and outcome analytics and solutions company in American healthcare, now with global capability, today announced agreement with HFACS, Inc., to develop, market, implement and support software technology of their Human Factors Analysis and Classification System (HFACS) to solve the medical errors epidemic. Quture intends to move past academic research and to continue Q’s achievements by improving patient outcomes, including patient safety, while reducing costs.

c1This agreement is extraordinarily significant to Quture for several reasons. First, Quture has sought proven experts in human factors technology to supplement its QualOptima product and services since 2009. Scott Shappell, Ph.D., and Douglas Wiegmann, Ph.D., are the renown pioneer developers of HFACS for aviation safety, working with the FAA and internationally. Drs. Wiegmann and Shappell developed HFACS in the 1980’s and 90’s, when aviation accident investigations needed a solution, just as healthcare now urgently needs their expertise. During the past few years, these experts have modified their system for patient safety in healthcare. Quture will begin working with them at their next HFACS training session in Daytona on June 7th and has already begun development of the HFACS software technology.

Preventable medical errors are the third leading cause of death in America. A study by patient safety experts at Johns Hopkins University Medical School calculated that 251,454 patients die every year from medical errors. That’s 689 preventable deaths per day, 29 every hour of every day. This rate of preventable medical errors is the equivalent of 604 crashes of 747 airplanes every year with all 416 passengers killed. That rate is more than one such 747 crash — every day of every year. And the evidence is that the crisis is not improving.

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The Complete Solution to the Medical Errors Epidemic Part 1

Preventable medical errors are the third leading cause of death in America.  A study by patient safety experts at Johns Hopkins University Medical School calculated the 251,454 die every year from medical errors.[i] That’s 689 preventable deaths per day, 29 every hour of every day.  This rate of preventable medical errors is the equivalent of 604 crashes of 747 airplanes every year with all 416 passengers killed.  That rate is more than one such 747 crash – every day.

The tragic loss of life and devastation of loved ones is difficult to comprehend, and the impacts on physicians and nurses working in health care is rarely considered.  The financial and economic consequences, and the burden on our legal system, are colossal.

The epidemiology, risks, and outcomes of preventable medical errors in health care have been extensively studied but remain poorly understood. Even more important, the solutions essential to eliminate these errors, often called “adverse events,” are yet to be accomplished.

Health care can learn from the process established in aviation safety, led by Scott Shappell, PhD, and Doug Wiegmann, PhD, now university professors of human factors, to accomplish patient safety.  In the late 1980’s and 1990’s, aviation safety embraced the realities of the industry and the need for a human factors framework.

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Q2x Initiative: Quture International + Quture Health (2)


When we designed the Quture logo in 2011, we very deliberately used a strand of DNA as the tail for the Q. When you unhinge the Q from the world in the Quture logo, it becomes even more evident. In fact, over the years we have used lines of computer code alongside lines of DNA code.N1

We envisioned the future of “personalized medicine” long before the evolving concepts for “individualized” or “precision” medicine and health became prominent initiatives in health care. Our experience and expertise in measuring clinical performance and outcomes, not relying on billing codes for our technology, has given us insight into the significance of calibrating evidence-based best practices to personalized optimal clinical processes.

The goal for this discussion is to explain why Quture Health is being launched now as our “Q2x Initiative.” The Q2x relationships will significantly make both companies stronger, with more upside potential for our business while empowering optimal clinical outcomes. Customer segments are all served better from each company’s perspective, value propositions and revenue models. Part 1 of this Note considered the business case of the Q2x Initiative from a business perspective. This Part 2 is devoted to the consideration of Q2x from the science and technology perspective; the business case for scientific technology: evolve or die.

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