ISO 9001

Leonardo BologneseCardiovascular Department, Arezzo, Italy

Fino a che punto è vantaggioso e dove cominciano i rischi per il malato?

L’ospedale per intensità di cura

ISO 9001

“Healthcare systems fail to provide treatments that are known to work, persist in using

treatments that don’t work, enforce delays, and tolerate high levels of error. Healthcare leaders

are now recognising . . .that the healthcare system needs radically redesigning.”

Smith J. BMJ 2001;322:1257–8.

Redesigning health care: radical redesign is a way to radically improve

ISO 9001

Two particularly important strands of influence for redesign

Total quality management (TQM)/continuous quality improvement (CQI)

Re-engineering

ISO 9001

How quickly the health care system is making improvement across the report’s core measure

Annual Median rate of Change

The annual rate of change from 1994 to 2005 was 2.3%

From 2000 to 2005, the annual median rate of change was 1.5%

www.ahrq.gov/qual/nhqr2007.pdf

ISO 9001

Radical transformational change of whole organisation simultaneously, abandoning current practice.

Focus on rethinking and redesigning processes from scratch.

Strip out all unnecessary steps.

Led from the top down—emphasis on strong management control and visionary leadership.

Decision making at the level where the work is carried out—team empowerment.

Requirement for flexible work practices.

Characteristics of re-engineering

Locock L Qual Saf Health Care 2003 12: 53-57

ISO 9001

Aziendalizzazione delle strutture sanitarieSuperamento dei vincoli procedurali tipici delle pubbliche amministrazioni

ed ampliamento della discrezionalità del management gestionale

ORGANO MONOCRATICO – Direttore Generale(nomina fiduciaria, esperienza professionale indefinita e formazione

imprecisata)

STRUTTURA DI DIREZIONE TECNICA E AMMINISTRATIVA(lasciata sostanzialmente invariata)

COMPONENTE PROFESSIONALE(forte tradizione di autonomia clinica e assistenziale e relativa autonomia

gestionale, ma priva di efficaci meccanismi di partecipazione all’elaborazione delle strategie aziendali)

ISO 9001

Aziendalizzazione delle strutture sanitarie

.....il processo di aziendalizzazione non ha ancora sviluppato un adeguato ed efficace sistema di relazioni fra il soggetto regolatore

e il management aziendale da una parte e fra questo e i responsabili del’operatività interna dall’altro.

L’obiettivo istituzionale alla qualità.........l’enfasi sullo sviluppo dell’efficacia e dell’appropriatezza delle prestazioni in opposizione a una semplice crescita quantitativa del loro volume...rischiano di

continuare ad essere affidati a comportamenti “virtuosi” individuali, volontaristici e inconsequenziali, e quindi

invitabilmente condannati all’inefficacia.

F. Taroni, R Grili, ASSR, Politiche Sanitarie Vol. 1, n.2, 2000

ISO 9001

NICENational Service Frameworks

ProfessionalSelf-regulation

Clinicalgovernance

Lifelonglearning

La strategia per la qualità del servizio sanitario inglese

A First Class Service, 1998

National Performance FrameworkCommission for Health Improvement

National Patient and User Survey

ISO 9001

GOVERNO CLINICO: Il Principio InformatoreRiequilibrare il Potere e le Responsabilità

all’interno delle organizzazioni

Responsabilità dei professionistiCambiamento culturale

FormazioneSistemi premianti

DIPARTIMENTI

COLLEGIO DI DIREZIONE

Responsabilità critiche nodali per il

Governo Clinico

ISO 9001

A “one-stop shop” where virtually any aspect of circulatory illness from prevention to management can be provided

Such centers convey a degree of specialization and expertise

Provide the optimal incubator for the fully integrated cardiac imaging and vascular interventional training programs

Translational and clinical research will be favorably affected

Fueled by the potential of clinical care, educational, research, and marketing benefits, we now appear to be moving towardfocused, integrated, multidisciplinary cardiovascular centers.

ISO 9001

Seeing the Process: What is our Current Condition?

1. No plans for patients (therefore status checks impossible)2. Departmental working hours are not synchronized3. Capacity (staff) are not calculated to meet demand4. The frequency of interventions are not designes to meet demand

ISO 9001

Hospitals under pressures: toward focused-care hospitals

Financial

Institutional and social: high quality health care and standardization of clinical practice are demanded by both consumers and professional regulatory bodies;

Clinical: boundaries of medical specialties need to be redefined to prevent new “turf wars” driven by different but overlapping technologies-competences-specializations for the treatment of the same pathology

Professional: new professions are emerging which claim similar status to doctors while other traditional professions, as nurses, are demanding status

Villa S et al. Health Care Manag Sci 2009;12:155–165

“the care-focused organization” reshapes hospital care delivery processes around the

needs of patients and away from the traditional physicians-centred view

ISO 9001

L’ospedale organizzato per intensità di cure

ISO 9001

• CONGRUENZA VERTICALELivello di cura e assistenza appropriato al bisogno

• INTEGRAZIONE ORIZZONTALEGli specialisti intervengono sui pazienti “ovunque essi siano”, si favorisce la collaborazione multidisciplinare e lo sviluppo dei percorsi

ISO 9001

COMPETENZA E INTEGRAZIONE DEI PROFESSIONISTI

Il medico tutor prende in carico il paziente, stende il piano clinico ed èresponsabile del percorso; si interfaccia con il MMG ed e’ il referente del paziente e della sua famiglia. L’infermiere referente è responsabile dell’assistenza e dei risultati del progetto assistenziale. Gli altri infermieri svolgono il ruolo di “associati”: erogano prestazioni e garantiscono la continuità assistenziale in assenza dell’Infermiere referente.

ISO 9001

Il riordino per intensità di curaInterpretazione del riordino per intensità di cure da

parte degli amministratori

UTIC Area ad elevata intensità di cure o HDU

EcardiografiaCardiologia Nucleare Strutture ambulatoriali RadiologiaLaboratorio di Emodinamicae Elettrofisiologia

Cardiologia Degenza Area ad int. o bassa intensità di cure

Aree critiche a HDUcompetenze multiple

RISULTATO: la dissoluzione della Cardiologia!

ISO 9001

Differences in treatment and outcome of patients with acute myocardial infarction admitted to hospitals with compared to

without departments of cardiology

European Heart Journal 2001; 22: 1794–1801

ISO 9001

Does it matter where you go with an acute myocardial infarction?

Compared to patients treated in hospitals without a cardiology department, patients treated in hospitals with a cardiology department had a better clinical outcome, a lower hospital

mortality, a lower rate of heart failure at discharge and a lower proportion of patients with a prolonged hospital stay.

Clinical outcome after myocardial infarction may differ depending on the setting: type of hospital (with or without cardiology department), type of

doctor (cardiologist or generalist), choice of reperfusion therapy (angioplasty or thrombolysis), and patient load

all have a significant impact on clinical outcome

The National Heart, Lung, and Blood Institute’s National Heart Attack Alert Program Coordinating Committee

ISO 9001

STEMI – Mortalità a 30 giorni aggiustata per comorbidità

SDO 2006-2008 Regioni Lombardia, Friuli Venezia Giulia, Emilia Romagna

Istituto Superiore di SanitàConsensus Conference FIC sulle SCA-NSTE GIC 2009

0

5

10

15

20

25

30

< 65 65-75 > 75

2.3

19.623.3

6.3

26.4

16.7 CardiologiaAltro%

Età

ISO 9001

Six Sigma

Lean/Toyota Production System

Studer Group‘s Hardwiring Excellence

Transformational strategies promising improvements along all dimensions of quality and performance adopted from manufacturing

ISO 9001

Ospedale lean per intensità di cure

ISO 9001

ISO 9001

It would have been more useful for someone in management science make these

observations before the current fiascoSteve

Harvard Business Review January 2010

Long the quality and efficiency standard-setter, Toyota now has an ostrich-sized egg on its face — a problem

with sticking... Steven Spear

Learning from Toyota’s Stumble

ISO 9001

“If one asks the question, Can the Toyota Production System (Lean) be applied in health

care? The quick answer is yes.”

“In healthcare, Lean is about shortening the timebetween the patient entering and leaving the carefacility by eliminating all non-value added, time,

motion and steps”

Fixing healthcare from the Inside, Today

Spear, Steven J. Harvard Business Review, 2005, 83:78-91

ISO 9001

Lean principlesPrinciple 1: Provide the value customers actually desire

Principle 2: Identify the value stream and eliminate waste

Principle 3: Line up the remaining steps to create continuous flow

Principle 4: Pull production based on customers consumption

Principle 5: Start over in a pursuit of perfection “the happy situation of perfect value provided with zero waste”

The key concepts are: value, waste and flow

Understanding Lean Thinking

ISO 9001

Common Elements of Re-Engineering according to Lean Thinking Principles

Decentralization of allied health and ancillary personnel to patient units. Cross-training of unit-based workers with varying

educational backgrounds and expertise to take on tasks traditionally outside of their scope of work-blending. A "team" is thus created, which in theory is more efficient

because workers can be substituted for each other. Patient satisfaction might be enhanced by having a wider

range of unit-based services and personnel, thus giving rise to the re-engineering label "patient-focused care."

ISO 9001

Removing the Triangles ……Responsibilities for Everyone

ISO 9001

The intuitive link between value streams and patient pathways or flows: the potential for clashes due to

different concepts of value (quality)

Young TP, McClean SI Qual Saf Health Care 2008; 17: 382-386

From this case study, it is clear that there are at least two dimensions of patient-centred value, namely one based around the responsiveness of the system and

another that addresses clinical priorities

ISO 9001

What is the extent to which the evidence for effectiveness is demonstrated in well-structured research and communicated via the peer-reviewed literature for current popular transformation strategies?

Likewise, what evidence exists these transformational strategies change both practices and organizational culture?

What is the Evidence?

ISO 9001

Johns Hopkins, Mount Sinai, Virginia Mason in USA, Flinders in Australia, Oxford Radcliffe and Bolton in UK

It is supported by the Institute of Healthcare Improvement in USA and the National Health Service Modernization Agency in UK

Evidence-based Management vs Champions-based Management

Success Stories

ISO 9001

Selection Criteria. Articles were included in the analysis if

The need to demonstrate and communicate the effectiveness of transformation strategies in healthcare: A critical review of the research literature on Lean Thinking/Toyota Production System

Vest JR and Gamm LD Implementation Science 2009, 4:35

appeared in a peer-reviewed journal described a specific intervention; were not classified as a pilot study; provided quantitative data describing the effect size or statistical significance;were not review articles

ISO 9001

RESULTS: 9 studies!!Hospital laboratories (5 studies)

A telemetry unit (1 study)

A gynecologist and his associated cytology laboratory (1 study)

Intensive care units (1 study using real-time problem solving to eliminate central line infections)

Hospital-wide (1 study using a patient safety alert system to reduce error)

Vest JR and Gamm LD Implementation Science 2009, 4:35

ISO 9001

However, the majority of the studies:routinely omitted statistical analysis, violated statistical test assumptions, failed to adjust for confounding,introduced selection biasfailed to include a comparison group increasing

potential sources of invalidity

The reviewed studies universally and enthusiastically concluded the implementations of this transformation strategy was successful in improving a variety of healthcare related processes and outcomes.

RESULTS

Vest JR and Gamm LD Implementation Science 2009, 4:35

ISO 9001

Does restructuring hospitals result in greater efficiency?

Hospital structuresTraditional–professional (TP) professionalized

nature of these organizations, dominated as they are by the training, values and professional norms of cliniciansClinical–divisional (CD), groups services

around the way medicine is organizedClinical–institute (CI), groups services around

patient conditions

Braithwaite J et al. Health Services Management Research 2006;19: 1–12

20 major teaching hospitals in Australia’s

ISO 9001

Results of ANOVAs comparing yearly costs ofTP, CD and CI structures

Braithwaite J et al. Health Services Management Research 2006;19: 1–12

ISO 9001

Results of McNemar tests comparing numbers of

hospitals with high and low efficiency before and after

structural change

Relationship of type of structural change and efficiency

Braithwaite J et al. Health Services Management Research 2006;19: 1–12

ISO 9001

An overly positive conclusion about Lean thinking fails to take into account the variety of issues

surrounding its application to health care. Organizations may think twice before embracing on

such a journey, or worse, superficially implement lean thinking, adding to existing resistance and making it more difficult to improve health care in the long term.

Joosten T, Bongers I, Janssen R Scientific Centre for Care and Welfare, The Netherlands

International Journal for Quality in Health Care 2009; 21: 341–347

ISO 9001

Two essential dimensions in transformation

Vest JR and Gamm LD Implementation Science 2009, 4:35

ISO 9001

Plan-Do-Study-Act (PDSA)

Improving the daily practice of medicine requires making changes in processes of care. In many circumstances, the

most powerful way to make such changes is to conduct small, local tests—Plan-Do-Study-Act (PDSA) cycles—in which one learns from taking action. For many system improvements, PDSA cycles are more appropriate and informative than the mere implementation of changes

without reflection or evaluative measurement.

Developing and Testing Changes in Delivery of Care

Donald M. Berwick Ann Intern Med 1998;128:651-656

ISO 9001

Reducing the richness of professional health care practice to impoverished snippets of work that are valued by time, cost

and spurious notions of quality may indeed add to the problems of hospital misadventure and patient management,

rather than solve them.

Winch S and Henderson AJ MJA 2009; 191:28

Making cars and making health care: a critical review

Heahth care professionals are tipically intelligent well trained people who have

chosen careers expressly to cure an comfort. All they need is the opportunity to do so!