Quality is everyone's responsibility

William Edwards Deming (1900 – 1993)

THE QUALITY-SAFETY-EXCELLENCE-ACCOUNTABILITY (QSEA) MODEL

The new perspective for the Healthcare management is that the Healthcare system must be regarded as a High Reliability Organization (HRO). Daily dealing with people health and people life, a hospital setting should be in fact the typical example of a HRO.
High Reliability Organizations are complex systems usually operating in a high-stress environment, aiming at giving their clients specific and preordained results (the final goal), collaterally managing goods of great values from the clients themselves (the intermediate trust) and always accepting the philosophical concept that mistakes did happen, do happen and will happen.
A complementary definition of HROs can describe them as autarchic systems that are able to answer all the possible inconveniences in real time, that is systems able to answer all the incoming problems using preexisting and pre-validated behavioural frames.
Some HROs seem also to share the crucial feature of managing people lives just to offer them very sophisticated goals as very common or basic goods: therefore HROs cannot but be High Performance Organizations. HROs must always tend to the excellence which is the virtuous and prospective combination of Quality (Technical Q + nonTechnical Q) and Safety (Technical S + nonTechnical S). Both the Quality (a dimension primarily about the performance result) and the Safety (a dimension primarily about the single client) depend either on human and structural variables. The certified performance Excellence is in turn the basis for the whole system Accountability (a dimension primarily about the community). The deep essence of the system Accountability is the official, clear and uptodate communication to all the potential stakeholders about the performance level granted by the system itself. The Accountability model is a clear step towards a world of informed and responsible choices from all the potential stakeholders and of virtuous competition among similar systems. The QSEA model is then a linear model starting from intrinsic and separated systemic features and getting to a dimension of public and unitary communication and certification.

Regarded as a HRO, a Healthcare system must always work for reaching the excellence as opposite to the mean standard. The best clinical outcome for every patient is the everyday mission for every Healthcare system
Regarded as a HRO, a Healthcare system must always work for reaching the excellence as opposite to the mean standard. The best clinical outcome for every patient is the everyday mission for every Healthcare system.
An easy example of a HRO is the airplane: it is a close system that routinely manages passengers lives (the intermediate trust) to make them fly big distances all around the world (the final goal nowadays perceived as a normal result) and that can trust only in the trained cabin crew capabilities to solve all the inflight problems (the autarchic connotation).
Every human rule is the preventive response to a perceived systemic vulnerability
A quite different HRO model can be imagined for the Healthcare system, where the final goal and the intermediate trust are about the same good (people health), where the intermediate trust is about a deficient health and where the final goal is about the restoration of a perfect health. Opposite to the linear HRO model from the airplane set, such a circular HRO model brings a different rule to describe the Negative Outcome Risk (NOR) of the whole model, being the NOR the most important public label for a HRO. For linear HRO models: NOR ≡ SNOR, where SNOR is the System Negative Outcome Risk that is the intrinsic NOR for a certain HRO. For circular healthcare HRO models: NOR = SNOR + PNOR, where PNOR is the inerasable Patient-linked NOR (the natural risk for a certain disease to get worse despite of correct medical intervention).
In HROs the structural complexity itself entails the existence of systemic risks of failure (SNOR). In other terms, a zero NOR HRO does not exist. A HRO is by definition not an infallible system (infallible human systems do not exist), it is otherwise a fallible system where Basic Risk Management projects and Crisis Management projects do exist and do successfully work. The combination of the Basic Risk Management and the Crisis Management can be defined as the System Vulnerability Management. In such perspective, small NORs are the first result of virtuous System Vulnerability Management processes.
The crisis is a negative stressing circumstance requiring the use of extraordinary energies to restore the homeostatic balance of the whole system. A crisis must always be managed and it can be solved, attenuated or simply communicated to the stakeholders. The detection time of a mounting crisis is a crucial variable for its management: the sooner the detection, the greater the chance for solving or attenuating its negative effects

Every human rule is the preventive response to a perceived systemic vulnerability.
An effective Clinical Risk Management project is able to reduce the frequency of the clinical mistakes and of the clinical crises and also to reduce the measure of the patient damage consequent to a clinical mistake. An effective Clinical Crisis Management project helps the medical team to answer a clinical crisis the best and the fastest way. Under a certain point of view, the effective Clinical Crisis Management provides the plug for some of the holes in the Reason’s cheese slices of an imperfect Clinical Risk Management. However, not all the clinical crises come from Risk Management failures.
The crisis is a negative stressing circumstance requiring the use of extraordinary energies to restore the homeostatic balance of the whole system. A crisis must always be managed and it can be solved, attenuated or simply communicated to the stakeholders. The detection time of a mounting crisis is a crucial variable for its management: the sooner the detection, the greater the chance for solving or attenuating its negative effects. In the clinical setting, every crisis increases the SNOR and can produce either a real Negative Outcome or a terminal Medical Malpractice Claim. According to the crisis detection time, we can identify crises simply determining an increase of the SNOR (I class crises) and crises already determining a NO (II class crises) or a MMC (III class crises). As the worst example, IV class crises are crises recognized and managed after two or more similar crisis experiences.

  Resolution Attenuation Communication
I class crisis + ++ +++
II class crisis +/- +/- +/+
III class crisis - - +/-
IV class crisis
(for the previosus episodes)
- - -

Crucial tools for both the Risk Management and the Crisis Management are the Incident Reporting Systems (IRS), the Root Cause Analysis (RCA) and the Failure Mode and Effects Analysis (FMEA). Like in a virtuous circle, all the previous mistakes must learn something (IRS, RCA) and the analysis about the happened mistake must identify and erase the systemic permitting basis for it (FMEA). The Incident Reporting should be about Averse Events, no-Harm Events and Near Misses and it should be a no-blame activity. Differentiating the risk pathway potentially leading to a negative outcome from the negative outcome itself:

  Risk Pathway Negative Outcome
Adverse Event Completed Happened
No-Harm Event Completed Not Happened
Near Misses Not Completed Not Happened

Resting on the human professional competence of the whole resident clinical and non-clinical team (HumPC = Hum Clinical Competence + Hum nonClinical Competence) and on the value of both the hospital environment (E) and the resident technical equipments (TE), an effective System Vulnerability Management (SVM) guarantees the patients to receive the best hospital care (BHC). In very basic mathematical terms: BHC = HumPC + TE + E + SVM, a formula very similar to the general SHEL paradigm by Edwards (Software + Hardware + Environment + Lifeware, where S ≈ SVM, H ≈ TE, E ≡ E and L ≈ PC) used for describing and analyzing the performance status of every human system.

All the hospital workers must be specifically trained for the crises recognition and the crises reporting
One or more failing addends in this sum clearly determine the performance level in a certain medical setting to separate from the optimal one, thus creating a relevant medicolegal issue. Every single hospital placing distant from the HRO paradigm (a quite common circumstance in the Authors professional experience) is a relevant medicolegal issue.
All the hospital workers must be specifically trained for the crises recognition and the crises reporting.
A special attention must be paid to the Clinical Competence. The CC is a professional competence further to get after academic degrees. It is a complex and dynamic combination of singular talent, everyday experience, personal ongoing training and never-ending professional updating. The so-called pyramid of the CC has the theory (the academic contribution) as the first and the widest floor, the performance capability (the capability of using the right theoretic basis inside a real case) as the second and intermediate floor and the action (the good everyday practice) as the third and the smallest floor.
Every small clinical crisis can detonate in the public opinion thus growing much bigger and much more painful for the hospital. Macroscopic clinical crises must be managed by professional Crises Managers and by trained Crisis Teams according to the general theory of the non-clinical Crisis Management
The pyramid apex is represented by the faculty of teaching. The smaller the floor of a certain pyramid level, the smaller the amount of practitioners able to reach it and to stay there: the CC can be also a tool to make professional selection towards excellence. The CCs from different practitioners can synergically act towards the excellent performance status of a Healthcare system (a shift from the SHEL model to the SHELL model by Hawkins).
The combination of E and TE can be seen as the measure of the basic Hospital Competence (HospC). The SVM rules the meeting between the HumPC and the HospC.
The Clinical Risk Management aims at reducing the SNOR and at preventing the Clinical Crises: it is obviously an anticipatory management and it is about an epidemiological dimension. The Clinical Crisis Management aims at erasing or reducing the negative outcome for a definite single patient (NO) and also the connected damage for the hospital, from the perspective that every private NO is the basis for a hospital loss. The Clinical Crisis Management can be therefore considered as the individual dimension of the Clinical Risk Management (NO versus NOR).
Every small clinical crisis can detonate in the public opinion thus growing much bigger and much more painful for the hospital. Macroscopic clinical crises must be managed by professional Crises Managers and by trained Crisis Teams according to the general theory of the non-clinical Crisis Management. Every hospital should have its own Crisis Consultants and Crisis Managers for managing all the macroscopic crises. For a hospital, even the simple or temporary loss of reputation is a cancer.
The Clinical Crisis Management (a specific version of the Crisis Resource Management already developed for the airplane crews and for many other professional fields) interested first of all the anesthesiologists as the specialists of the emergency medicine, but nowadays it should widen its influence on all the hospital crews. In fact the crisis response cannot but be an organized team response. Generally considered as acute and not prevented problems needing a very fast solution to avoid very negative outcomes, the clinical crises may be very heterogeneous coming for example from an intra moenia cardiac arrest (a very typical kind of a pure clinical crisis) to the management of an exanguinating patient refusing blood transfusions for a religious purpose (a kind of medico-legal crisis quite common in Italy).
A new branch of the forensic medicine deals nowadays with global Healthcare systems organization and can exploit its traditional background about ex-post judicial analyses on clinical malpractice cases to optimize the Healthcare systems evolution, to lead the SVM and to prevent future clinical mistakes. To do this, the forensic medicine must intensively cooperate with other clinical and non-clinical branches. The contribution from this kind of forensic medicine can help to establish real evidence-based SVM projects. Programming and executing failures about the Risk and the Crisis Management are in fact autonomous sources for clinical malpractice and for clinical malpractice claims. As written above, also a clinical malpractice claim is a crisis to be managed at best (III class clinical crisis). A simple theoretical model to describe the Malpractice Claim Risk in individual cases assumes the MCR as a function of the Negative Outcome measure: MCR = k x NO, where

  1. NO = Expected Clinical Outcome (ECO) - Reached Clinical Outcome (RCO)
  2. k is a patient-linked variable = Social Network Effect (SNE) + Experience-linked Anger (EA)
  3. ECO is influenced by the patient Personal Technical Knowledge (PTK)
  4. PTK = 1 = Good PTK + Bad PTK
  5. Bad PTK directly correlates with ECO and with MCR
  6. Good PTK inversely correlates with ECO and with MCR.

According to this model, after the NO production the MCR can be still partially managed working on the patient-linked k variable and above all working on the EA. Professional psychologists can manage such crises at best and therefore they must be always present inside a virtuous Healthcare system. Professional psychologists may also run at best all the precious Alternative Dispute Resolutions pathways. On the contrary, specialized lawyers will manage at best all the judicial disputes about medical malpractice. Specialized forensic pathologists will be in turn useful for the ADR attempts and necessary for the judicial proceedings.
Shifting from a singular perspective to an epidemiological one, the cumulative MRC per year is another main label for a HRO and it will influence the concrete chances for a certain hospital to find and to maintain a good insurance coverage. Specialized insurance brokers are always needed to tailor the best insurance coverage for Healthcare systems.

For a certain hospital, the cumulative MCR directly correlates with the gap between the Best Hospital Care (BHC = 10/10 HPC + 10/10 TE + 10/10 E + 10/10 SVM) and the Current Hospital Care (CHC = x/10 HPC + x/10 TE + x/10 E + x/10 SVM). An excellent Healthcare system shows a Hospital Care gap very close to zero, while an accountable Healthcare system (made up by Accountable Care Organizations) is an excellent system that can publicly certify all its performance virtues.
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