Il Processo di Produzione nel Laboratorio che Cambia: Aspetti

La professione del Biologo tra
Scienza e Industria
Corso di Formazione
“Professione Biologo”
Roma, 14 Giugno 2012
Pasquale Mosella
La professione del Biologo tra
Scienza e Industria
Lab. Analisi




Acquisire
competenza
Acquisire
conoscenza
Accrescere
esperienza
Generare fiducia
Industria




Acquisire
competenza
Acquisire
conoscenza
Accrescere
esperienza
Generare fiducia
Ricerca




Acquisire
competenza
Acquisire
conoscenza
Accrescere
esperienza
Generare fiducia
La professione del Biologo tra
Scienza e Industria






Passione
Determinazione
Tenacia
Coraggio
Voglia di
esplorare vie
nuove
Responsbilità &
Rischio






Passione
Determinazione
Tenacia
Coraggio
Voglia di
esplorare vie
nuove
Responsbilità &
Rischio






Passione
Determinazione
Tenacia
Coraggio
Voglia di
esplorare vie
nuove
Responsbilità &
Rischio
Chi, come, dove, quando...

1980-2012 : spunti e riflessioni circa la
professione, tra cambiamento e
trasformazione dell’HealthCare.
Corso di Formazione
“Professione Biologo”
Roma, 14 Giugno 2012
Pasquale Mosella
All’interno degli ospedali, il Laboratorio
analisi, proprio per il ruolo strategico che
svolge nella erogazione di servizi, viene
sempre più chiamato a incrementare non
solo la capacità produttiva, ma soprattutto
l’efficienza produttiva.
La necessità di migliorare la situazione
finanziaria impone una elevata attenzione
alla razionalizzazione dei costi.
La riduzione dei costi va
affrontata in maniera globale
prendendo in considerazione il
processo di produzione attraverso
l’analisi dei flussi di lavoro e
analizzando le singole necessità
DISEASE MANAGEMENT
FASI PROCESSO PRODUTTIVO
PRE
Analitica
ANALITICA
POST
Analitica
Processo Produttivo
PRE
Analitica
Analitica
POST
Analitica
Information data management
Analytical
Sample handling
L’ANALISI DEL PROCESSO
PRODUTTIVO, QUINDI DELLE
SUE VARIE FASI, E’
INDISPENSABILE PER
ARRIVARE AD UN PRODOTTO
DI QUALITA’
LA QUALITA’ DEL PRODOTTO
E’ QUINDI IL RISULTATO
DELLA QUALITA’ DEI PROCESSI ATTUATI
SI PUO’ MIGLIORARE
L’EFFICIENZA PRODUTTIVA
ATTRAVERSO L’AUTOMAZIONE
L’AUTOMAZIONE RAPPRESENTA
LA CONDIZIONE INDISPENSABILE
PER AVVIARE UN PROCESSO
DI RIDUZIONE DEI COSTI DI GESTIONE
 Process
improvement
 Data
management
enhancement
 Lab
automation
AUTOMATION FOR THE CLINICAL LAB
 Bar
coding
 Front
end automation
 Work
cell automation
 Total
automation
 Remote
 Mobile
control POC testing
robots
 Robotic
arms
 Separation
and sorting
Automation is a
SYSTEMATIC PROCESS
and not simply the purchase of hardware
Factors that will
automation are:
influence
succesful
use
 An enthusiastic workteam
 A well thought out strategic plan
 Standardization of specimen containers
 The reduction in exception specimens
 The widespread use of P.O.C. testing
of
Goals to define when establishing a fully
automated clinical lab operation
 Cost
controls
 Increase
capacity for testing throughput
(increasing productivity)
 Improved
 FTEs
TAT
reduction
 Return
on investment (ROI)
Componenti del costo per campione
Postanalitica
15%
Analitica
45%
Preanalitica
40%
60%
degli errori
di laboratorio
QUALITA'
COSTO
TEMPO
UN OBIETTIVO FONDAMENTALE
DELL’AUTOMAZIONE
DEL LABORATORIO
E’ QUELLO DI
FORNIRE INFORMAZIONI
AL CLINICO
IN TIME TO DO ANY GOOD
FOR THE PATIENT
LA RIDUZIONE PIU’ CONSISTENTE
DEI COSTI (QUELLI COMPLESSIVI
DELL’AZIENDA OSPEDALIERA)
PUO ESSERE REALIZZATA
ATTRAVERSO L’OTTIMIZZAZIONE
DELL’ATTIVITA’ DEI MEDICI DI REPARTO
COMPORTAMENTO “MANAGERIALE”
DELLA PRATICA CLINICA
RIDUZIONE DELLE GIORNATE DI
DEGENZA NON APPROPRIATE
BISOGNI
DOMANDA
OFFERTA
QUALITA'
COSTO
TEMPO
CPR
CONTINUOUS
PATIENT
REPORTING
LABORATORIO ANALISI
Chimica Clinica
87%
Immunochimica
Ematologia
Coagulazione
Urine
Prot&Elettr.
Laboratorio fino agli anni 90

Singole aree in relazione alla tipologia degli
esami richiesti (elevato numero di strumenti)

Personale vincolato alla propria area

Campioni ai settori su richiesta cartacea

Le tre fasi del processo ben distinte

Costi gestione elevati

Al settore urgenze aumenta l’attività
PROCESSO DI PRODUZIONE
RICHIESTA
REFERTO
PRE ANALITICA
7.30
8
9
10
11
ANALITICA
POST AN.
12
15
13
14
16
Laboratorio Analisi fino al 90
Microbiologia:
Isolamenti con metodi classici
ID e DS con strumenti semiautomatici
Tempi di risposta non inferiori alle 72 ore
Sierologia:
Prevalentemente Ricerca Anticorpi
con metodi classici
Laboratorio dopo gli anni 90









Potenziamento LIS
Richieste su schede ottiche
Barcoding area
Riduzione numero strumenti
Ampliamento menù test
Aspirazione da tubo primario
Host query
Tutti i settori interfacciati al gestionale centrale
Riorganizzazione area ad alta automazione
(core lab)
Laboratorio Analisi dopo il 90
Microbiologia:
Strumentazione automatica per ID e DS
Sistemi per emocolture
PCR - LCR
Interfacciamento al Gestionale Centrale
Sierologia:
Ricerca anticorpi su micropiastre
Blotting e Amplificazione
Processo di produzione - Lab. Urgenze
PRE
Analitica
PRE
POST
Analitica
PRE
POST
Analitica
PRE
POST
Analitica
PRE
Analitica
PRE
POST
Analitica
PRE
0
POST
12
POST
Analitica
POST
24
Orario utile per la refertazione
RIAN
9
UTIC
9
ONCO
MED
10.30
10
OST
INF
P.S.
11
10
entro 20-30 min.
SPECIMEN RECEIVED TIME
8.00
9.30
7.30
0.
00
0.00
12.00
24.00
CONTINUOUS PATIENTS REPORTING
LAB. ROUTINE
LAB. URGENZE
C. P. R.
OPEN SPACE
CORE LAB
CONTINUOUS PATIENTS REPORTING
PRE Analitica POST
PRE Analitica POST
PRE Analitica POST
PRE Analitica POST
PRE Analitica POST
6
Campioni
7
8
9
1°St.
100
10
11
2°St. 3°St.
200
350
12
13
14
4°St. 5°St.
650 Tutti
CONTINUOUS PATIENT REPORTING
CORELAB INTEGRATION









Increase progressive automation through specimen
matrix tube division
Sample handling
Data management enhancement (LIS - HIS)
Autovalidation
24 h ready
Barcoding area department
Buy work from other labs
Patient-side testing system (next generation of POC
technology)
Involving lab staff (FTEs)
CORELAB LAYOUT
CHIMICA CLINICA
IMMUNOCHIMICA
NEFELOMETRIA
E
M
A
T
O
L
O
G
I
A
COAGULAZIONE
URINE
EMOGAS
Patient-side testing system

Test di emergenza

Rapido TAT

Massima efficienza

Riduzione dei costi

Controllo remoto dal laboratorio
IL LABORATORIO DOPO IL 2000
POC
POC
CPR
85%
POC
POC
IL LABORATORIO DOPO IL 2000
Microbiologia:
Automazione per Isolamento, ID e DS
Diagnosi rapida con metodi diretti
Tempi di risposta 6 - 24 ore
Sierologia:
Automazione dei sistemi su micropiastra
Consolidation su analizzatori del
corelab
Prevalentemente Ricerca Antigeni
Ospedale del nuovo millennio

Pochi e ad alta tecnologia

Trattamento di patologie acute

Interazione con il territorio:
Ospedale
collegamento in rete con le strutture
ed i medici di medicina generale

Internet
Territorio

Potenziamento compiti di supporto
all’ospedale: riabilitazione, home care,
distretto sanitario, hospice, ecc.
Protagonista dello sviluppo del nuovo
modello di Ospedale in rete sarà
INTERNET
Health Care Service
Integration of POCT in LIS
E - mail
NEAR FUTURE
Point of Care Testing
Molecular Diagnostics
New Technologies for the new Millennium
GENE CHIPS
MINIATURIZATION and FLUIDICS
BIOELECTRONIC DETECTION OF DNA
2° Eurolab Automation - London - October 1999
… however, developments in nanotechnology have opened up the
possibility of more bed side testing.
As this is likely to be a reality in the
next three years there will be a
movement of testing out of the core
laboratory and into the wards.
M.J. Wheeler
St. Thomas Hospital - London
2° Eurolab Automation - London - October 1999
The central laboratory of the future
is destined to become an esoteric
testing center, while routine testing
will be more economical when
administered at the patient bedside.
Robin A. Felder
University of Virginia - USA
Il laboratorio dopo il 2010
POC
POC
POC
Tests
esoterici
POC
POC
POC
POC
POC
Il Laboratorio dopo il 2010
POCT
MICROBIOLOGIA
HOME TESTING
LAB
E’ in atto un processo
irreversibile
di cambiamento che prima
ancora di essere tecnologico è
soprattutto culturale.
Ci si sta avviando verso la
“società della conoscenza”
dominata
dalla comunicazione globale.
BD Diagnostic Systems European Leadership Team Meeting
- 16th December 2008 Today Agenda
- Medical Devices Domestic Market
- The Italian NHS
- Healht Expenditure vs Finance
- Public Sector’s Financial Crisis
- Late Payments
- Key Aspects of Regional Governance
- Public vs Private Healthcare Providers
- Reimbursement schemes
- HTA
- Centralized Purchasing Policy
- Key Aspects of National Governance
- Reference Prices
- National Repository of Medical Devices
ASSOBIOMEDICA
Assobiomedica is the Italian Federation of four National Associations
BIOMEDICALS
IVD
ELECTROMEDICALS
SERVICE &
TELEMEDICINE
ASSOBIOMEDICA
ORTHOPAEDICS, DYALISIS, CARDIO, SUTURES, INCONTINENCE,
INFUSION, LAPAROSCOPY, WOUND CARE, UROLOGY, OSTOMY,
ANAESTHESIOLOGY, TNT, NEUROSURGERY, BREAST PROSTHESIS,
…
LABORATORY, SELF-MONITORING, ALLERGY THERAPIES,
RADIOPHARMA
IMAGING, ULTRASOUND, EM, EM-PM, HEALTHCARE-IT
Medical Devices World Market 2007
Rest of the World
16%
Japan
11%
U.S.
43%
21.100 companies
Europe (11.000) - U.S. (8.500) - Japan (1.600)
850.000 employees
Europe (435.000) - U.S. (350.000) - Japan (65.000)
€ 187 bill. sales
Europe
30%
Europe (56,1) - U.S. (80,4) - Japan (20,5)
EU New Members
5%
Italy
11%
France
16%
U.K.
11%
Spain
9%
Rest of Europe
Switzerland
16%
2%
ASSOBIOMEDICA
Germany
31%
Sources: Advamed, Eucomed, Assobiomedica
Assobiomedica Member Companies 2008
226 MEMBER COMPANIES
€ 6.200 million DOMESTIC MARKET
75% PUBLIC DEMAND
30.000 EMPLOYEES
TURNOVER SIZE
> € 40 million
€ 20-40 million
€ 5-20 million
151 TRADING COMPANIES
< € 5 million
16%
11%
43%
30%
75 MANUFACTURERS
ASSOBIOMEDICA
Source: Assobiomedica
Assobiomedica Member Companies 2008
Manufacturing Side
Marketing Side
DOMESTIC MARKET 84%
EXPORT 16%
PRODUCTION 31%
TOTAL SALES
€ 7,4 billion
IMPORT 69%
BIOMEDICALS + SERVICE & TELEMEDICINE € 3,2 billion
IVD € 1,7 billion
ELECTROMEDICALS € 1,3 billion
ASSOBIOMEDICA
Source: Assobiomedica
The Italian NHS 2007
Nr. Autonomous
Public Hospitals
Nr. ASL
Nr. Hospitals
managed by ASL
Nr. Contracted-Private
Hospitals
Nr. Other Hospitals
Piemonte
8
13
48
40
7
Valle d’Aosta
0
1
1
0
0
Lombardia
29
15
2
61
25
Veneto
2
21
57
16
12
Friuli Venezia Giulia
3
6
8
5
3
Liguria
3
5
10
3
5
Emilia Romagna
5
11
38
42
1
Toscana
4
12
26
27
5
Umbria
2
4
9
5
0
Marche
2
1
31
12
3
Lazio
4
12
52
79
19
Abruzzo
0
6
23
13
2
Molise
0
1
6
2
2
Campania
8
13
47
71
8
Puglia
2
6
27
37
7
Basilicata
1
5
13
1
2
Calabria
4
6
33
38
1
17
9
50
62
5
1
8
29
13
3
95
157
528
536
119
Region
Sicilia
Sardegna
ITALY
ASSOBIOMEDICA
Source: OASI Report, Bocconi University
Public Healthcare Expenditure 2005 (%)
• Human resources
32,8
• Goods&Services
27,4
• Pharmaceuticals
12,6
• NHS Contracted-private providers
27,1
• Other
•0%
•10%
•20%
0,9
•30%
•40%
•50%
•60%
•70%
•80%
•90%
•100%
•Human resources
•G&S
32,8
•12,6
27,4
•27,1
•Pharmaceuticals
•NHS Contracted-private providers
•Other
•0%
•10%
•20%
• Medical devices
• Other G&S
ASSOBIOMEDICA
4,7
22,7
Public Healthcare Expenditure 1990-2005 (%)
1990
2005
min.
Max
• Human resources
39,1
32,8
32,8 (2005)
43,3 (1997)
• Goods&Services
17,7
27,4
17,3 (1991)
27,4 (2005)
• Pharmaceuticals
17,6
12,6
10,7 (1995)
17,6 (1990)
24,7
27,1
24,7 (1990)
27,8 (2002)
0,9
0,1
0,1 (2005)
1,8 (1993)
• NHS Contracted-private
providers
• Other
ASSOBIOMEDICA
Public Healthcare Expenditure vs Finance 1990-2007
Annual deficit on GDP
2007
Expenditure € 103 billion
Funding
€ 95 billion
Deficit
€ 8 billion
1
0,8
0,6
• The annual deficit on GDP
is 0,35% on average.
• The ratio shows a rather
limited variability.
%
{
0,4
0,2
0
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005
Source: Assobiomedica
• All modern healthcare systems experience the same financial difficulties but this does not
prevent suppliers in those markets from getting payment within a reasonable timeframe.
• The point is that in other countries such deficits are promptly payed in full whereas in
Italy this does not happen.
ASSOBIOMEDICA
The Italian Public Sector Financial Crisis
• The Italian public sector has been experiencing for long a financial crisis.
• Public expenditure has been growing for many decades faster than revenues.
• As a result, our public debt as % of GDP is the second highest in the European Union (and very
far from the due parameter set by the Maastricht Treaty).
• There are not easy solutions for financial distress (and late payments) in the healthcare
sector.
• Healthcare represents, on average, the 80% of the total current expenditure at regional level and
it means that additional resources for healthcare cannot be expected to come from other regional
budgets.
• We cannot any more have the third largest market in Europe, the second highest public
debt on GDP, and the 75% of the domestic market made by public demand.
• Moreover, GDP is expected to decrease by 0,4% in 2008 and by 1% in 2009.
ASSOBIOMEDICA
Late Payments
• The finance of the NHS has never been effectively tackled by the National Legislator.
• Up to 1993, the State has been responsible for funding the healthcare expenditure and its
approach has been to allocate less money than the regions needed so that to encourage them to
pay attention on costs and expenditure.
• During this period the annual deficits were late payed by the State and the medical device
market grew fast.
• Market leaders, by not claiming for interest for late payment, enforced the general opinion
that prices include such interest computed on the basis of the expected DSO.
ASSOBIOMEDICA
Healthcare in(de)finite Demand vs limited Finance
• Since 1994 regions have been responsible for
funding their own healthcare expenditure in excess
over budget.
• Actually, most regions’ and local authorities’ fiscal
autonomy is still inadequate: e.g. due to the
abolition of the tax on the houses of residence in the
last year, local authorities will get 850 million euro of
fiscal revenues less in 2008; the Government (which
disposed the abolition) seems to be willing to
transfer only 260 million euro for compensation.
TR
VA
LO
FVG
VE
PI
High DSO
ER
LI
TO
MA
UM
LA
AB
MO
CA
SA
PU
BAS
CA
• If the problem were the same for any region, it
would be easier to tackle. Instead, profound
differences exist among regions (e.g. in terms of
GDP per person).
SI
140-160 % of EU-25 average at PPP
120-139 % of EU-25 average at PPP
100-119 % of EU-25 average at PPP
70-99 % of EU-25 average at PPP
60-79 % of EU-25 average at PPP
ASSOBIOMEDICA
Source: Eurostat
Health Technology Assessment

At the moment, no “HTA-Requirements” for formal admission to reimbursement system.

Utilization and dissemination of HTA Report is still quite limited.

Lack of central (National) strong coordination.

In the next future more and more RHAs will use HTA to influence the purchase
and diffusion of innovative medical devices within their boundaries.

Many decision makers think that so far innovation has been often adopted
without sufficient information about its efficacy and costs related to alternatives.

In the next future more attention will be put on activities such as horizon
scanning, priority setting and HTA.
ASSOBIOMEDICA
Health Technology Assessment
Emilia Romagna
Since the longest time structured HTA activity + high
skills & experience inside the Regional Health Agency.
Veneto, Lombardia, Toscana, Piemonte
Well-defined HTA regional programs have been launched.
Friuli, Lazio
Institutional HTA in early developing phase.
Hospital-based HTA Units (Hospitals where specific skills and
experience for procurement under HTA criteria have been
developed).
ASSOBIOMEDICA
The regionally-centralizated (or driven) purchasing policy in Emilia Romagna
• Intercenter is the Agency for the purchase of goods and services needed by health
authorities in Emilia Romagna.
• The model is characterised by a central management which defines technical specifications
of the goods and services to be acquired; logistic and administration aspects are managed
by local health authorities which are obliged to adhere to the contracts stipulated by
Intercenter.
ASSOBIOMEDICA
The National Governance of the Healthcare Service
Some measures adopted:
• Reference Prices
• National Repository of Medical Devices
• Late renewal of personnel contract
• Enforcement of the role of the Central Agency (Agenas)
ASSOBIOMEDICA
Medical Devices’ Reference Prices
Official publications of the Reference Prices List




Decree of October 2007
Decree of January 2008
Decree of April 2008
The restyling of the list is expected in a short while: 26 references will be delisted (e.g. some
endovascular prostheses) and 23 new references will be added (e.g. some pediatric vascular
prostheses); most prices will not be modified.

The products so far involved are very different from each other and the relative prices range
from € 0,018 (for a non-surgical glove) up to € 6.939 (for a particular endovascular
prosthesis).

Reference prices must be used by public hospital as base prices for public tenders.
•
Assobiomedica proposed an amendment to the next National Budget Law 2009 which is still
in discussion, with the objective to suspend the application of reference prices in 2009.
ASSOBIOMEDICA
Medical Devices’ Reference Prices
Critical issues

Risk of an extension of the reference prices published by the MoH even among Private
Hospitals.

The so-defined “equivalent” classes of products actually do not correspond to equivalent
supplies.

Risk that RHAs will keep on adopting their own reference prices even though the amendment
to the next National Budget Law 2009 proposed by Assobiomedica will be successful.
ASSOBIOMEDICA
Health Technology Assessment

The National Agency for Regional Healthcare Services (Age.Na.S, formerly A.S.S.R.),
founded in 1993, supports and co-ordinates regional activities in cost monitoring,
organizational challenges and HTA.

Coordinator Agency of National Plan for clinical guidelines.

Strong endorsement by the Conference of the Regions on HTA.

Important role of Agency in process of reference pricing for medical devices and key
stakeholder into the debate on alternative ways for governance of medical device sector.

Commissioned by the MoH to produce HTA reports on orthopaedics, in vivo and in vitro
diagnostics; the aim of these reports was primarily to test the process for a systematic activity.

Main Coordinator of “Progetto COTE”, a network for Horizon Scanning activities in Italy. The
project has been launched in september 2008 and is still in a developmental phase.
ASSOBIOMEDICA
Diagnostic Systems
Italy
The new Go to Market Model
Lux 28/06/2007
BD Italy CONTEXT MAP
INTERNAL TRENDS
OUTSIDE TRENDS
POLITICAL CLIMATE
•Strong uncertainty
•Purchase dept.
centralization (1 purchase
dept. for many labs)
•Merging and acquisitions
(customers and companies)
•Price oriented tenders
•Competition conflicts
•Raising awareness on HAI
•Focus on health care costs
rather than investments
ECONOMIC
CLIMATE
•Business consultant approach
Scientific/therapeutic &
Financial
•DRG reduction
•Financial law negatively
affecting companies
(price monitoring)
Focus on lower price
inst.of quality
CUSTOMER NEEDS
•Break “lab barriers”
New stakeholder & wards
exploring
•Profiles and skills diversity ex.
Workflow engineers
•Reorganization of strategic
centers
•Costs constraints
TECHNOLOGY
FACTORS
•Workflow analysis & KPI evaluation
UNCERTAINTIES
•Full & rapid automated system
•Quality/price balance
•“Zoonosis” conversion diseases
•High level after sales support
•Merging and acquisitions, global
contractor
•Rapid Tests request
•Scientific development
•Molecular Technology
•Urgent need of modular instruments
•Management skills development
•Key decision makers shift
•Regional hospitals merging
Driving Forces
TRENDS
FORCES
Economical
Professional
Demographical
Political
Growing Concern for HC Worker’s Safety & Environmental
Issues


Increasing Public Exposure to Infectious Diseases Issues

Uncontrolled HC Expenses Growth Exceeds GDP Increase

Growing Challenges of Infectious Diseases

Increasing Customer Education
Increasing
Aging Population

Low regard and visibility of Clinical Microbiology

Regulatory Pressure on IVD
New

Financial law
Lowering Attractiveness of HC Profession
Focus
on products and prices rather then on quality and
solutions
Driving Forces
CONSEQUENCES
Growing Concern for HC Worker’s Safety &
Environmental Issues

Increasing Public Exposure to Infectious
Diseases Issues

Control Program

Continuous Budget Pressure
Reimbursement & Budget
Pressure

Higher Needs for Performance

Increased complexity of the
Expenses

Uncontrolled HC Expenses Growth Exceeds
GDP Increase


Growing Challenges of Infectious Diseases
Decision Shift to Admin &
Finance (new stakeholders)

Increasing Customer Education
Tender

Increasing
cost impact
Aging Population
Low regard and visibility of Clinical
Microbiology


Rationing to Rationalising
Lab Concentration, Satellites,
Global Contractors


Regulatory Pressure on IVD
New

Financial law
Lowering Attractiveness of HC Profession
Focus
on products and prices rather then on
RESULTS
sales pathway

Process Optimization Focus

Integrated Global Approach
Future

Customised Instrument
Solution

Staff Shortage for cost reduction
Lab approach
Higher Information technology
request

Expert System & Automation
Driving Forces
Growing Concern for HC Worker’s Safety
& Environmental Issues

CONSEQUENCES
Increasing Public Exposure to Infectious
Diseases Issues

Uncontrolled HC Expenses Growth Exceeds
GDP Increase




Growing Challenges of Infectious Diseases

Increasing Customer Education
Increasing
Aging Population
RESULTS
Educated & Sensitive
customers/patients

Influence on Diagnostic tests
prescription
Mrsa
Regional

Political Programs
Improvement of
procedures in
medicine


Standardization


Primary Demand Patient
Targeted Co-Funding in Emerging
diseases
Regulatory Pressure on IVD
New
Screening Programs
Initiatives

Low regard and visibility of Clinical
Microbiology

CT Screening Program
More accurate Epidemiology
Financial law
Lowering Attractiveness of HC Profession
Focus
on products and prices rather then on
quality and solutions

Focus on prevention
Profile

Documented AB Therapies
Driving forces
Growing Concern for HC
Worker’s Safety & Environmental
Issues

CONSEQUENCES
RESULTS
Increasing Public Exposure to
Infectious Diseases Issues

Uncontrolled HC Expenses
Growth Exceeds GDP Increase


Higher Sensitivity to HCW
Growing Challenges of
Infectious Diseases
Increasing Customer Education
Increasing

Politically and Economically

Safety Educational Campaign

Preventive Programs & Cost

Epidemiology / Data Management

Value Opportunity for Clinical
driven processes
Aging Population
Low regard and visibility of
Clinical Microbiology
Risk Management
Safety





Regulatory Pressure on IVD
New
Financial law
Lowering Attractiveness of HC
Profession

Focus
on products and prices

Increasing focus on
Nosocomial Inf.
Micro Lab
The reason of changement
COMPANY
LAB
•Focus on products
•customer = lab
•only sales rep needed with a little
support from HQ FAS
• 100% personal relationships
CLINICAL
1980
CONTROLLER
PATIENT
The reason of changement
COMPANY
LAB
•Focus on products and instruments
•customer = lab + adm dept
•sales rep + FAS
•Tender process focus
• 85% personal relationships
CLINICAL
1990
Adm. dept
PATIENT
The reason of changement
•Focus on products and solutions
•customer = lab + adm dept +
clinical dept + CIO
•sales rep + FAS + pm +
management
•Tender and project process focus
• 75% personal relationships
COMPANY
LAB
CLINICAL
GM
Adm. dept
Hy. dept
2000
PATIENT/cust omer
1980 – 2007
FROM
Simple selling process
Few competence needed
Few resources needed
Focus on products
Sale and management of results
Datas
Microbiolgy Lab
Diagnosis
Prevalence of products and Technology
Product and service management
Test as diagnostic support
Focus on results (lab centralization)
TO
Complex selling process
Many competences needed
Many resources needed
Focus on projects
Sale and management of informations
Consulting
Cio, Clinical, General Management
Prognosis and Therapy
Prevalence of Organisation
Project and performance management
Test as prevention support
Focus on Process (POC + decentralizazion to wards)
The reason of changement
National/regional Govnmt
(guidelines and financial goals)
Lab
Hospital Management
KPI
(GM, ADM dept, Hy dept)
KPI
KPI
Clinical, wards
Patient/Customer
Family Physician
AssoDiagnostici 2011-2012
POLITICAL
CLIMATE
ECONOMIC
CLIMATE
• Conclamata fase recessiva
• Definitiva consapevolezza
della crisi
• Attesa del comparto
Industriale per maggiore
disponibilità di risorse
• Tregua responsabile a
sostegno del Governo
• Massima pressione fiscale
• Politica locale verso
Regioni
• Politica Regionale verso
Governo Centrale
• Precarietà nei riferimenti (a
tempo fino al 2013)
• Conflittualità sui costi della
politica verso
cambiamento
• Spending review in
funzione degli investimenti
• Attenzione immotivata e
inappropriata ai dispositivi
medici
• Difficoltà a coniugare
rigore economico e
necessità di crescita
CUSTOMER NEEDS
• Qualità e sicurezza
contrapposti al
razionamento
• Screening e prevenzione
• Scarsità di risorse e
ottimizzazione dei flussi
• Contenimento dei costi e
ridefinizione degli
investimenti
• Valorizzazione del ruolo e
riconoscimento della
centralità del Reparto
• Solvibilità del debito della
P.A.
• Ricambio culturale e del
Management della P.A.
• Difficoltà ad individuare I
giusti interlocutori
• Spending review in chiave
punitiva (ancora CONSIP)
• Revisione nomenclatore e
tariffari
• Gestione gare in chiave
razionamento (all.P ecc.)
GRAZIE!!!