PNA_foer_teknologer_..

Point of care testing
An introduction
With clinical experiences
Per Simonsson MD, PhD
Medical POCT coordinator
Department of Clinical Chemistry
University and Regional laboratories Region Skåne
Sweden

The region of Skåne
• 1.2 million inhabitants
• Regional health system
– 10 hospitals
– 150 primary care centers
– One labmed organisation

Focus of two innovations
Organisation
Merging of all 10 labs and their POCT
> 2000 POCT instruments
Technology
Venous blood gas analysis
Emergency departments

Organisation
Top-management decision:
“Actively participate in and be a knowledgebased
support to regional and local health
care.
Be responsible for quality assurance and the
choice of methods and instruments in point of
care testing in Region Skåne.
Agreements shall be signed between health
care providers and Labmedicin Skåne.”

POCT organisation in Skåne
• Strong management support
• New regional organisation
– Leadership
– Medicine
– IT
• Local POCT coordinators
– Hospitals
– Primary care
• Interaction with core lab
• Clinical collaboration

Our POCT markets
• Primary care
• Local hospitals
• Emergency care
• Specialised care
10 hospitals and EDs

Our POCT customers
Different
interests,
responsibilities
language …
Management
Doctors
Nurses
Labmedicine Skåne
Clinical health care

Our POCT customers
Different
interests,
responsibilities
language …
Management
Economy
Doctors
Diagnostics
Nurses
Running POCT
Labmedicine Skåne Clinical health care

POCT services - Principles
• All inclusive
– We do everything – except analyse your sample
• Based on medical needs
• Creating the right mix
– TAT (Turn around time) vs quality
– TAT vs costs
– POCT vs central lab

POCT services - Operation
• One team of POCT coordinators
– QA, training, IT, service, logistics, accreditation.
• Harmonisation and standardised services
– Procedures, QA and accreditation
– Training
– IT

POCT services - Management
Written agreements with customers
Mandatory
Defining responsibilities and service levels
Economy
Price list for different services and instrument
– > 2 000 small POCT instruments
– > 30 POCT blood gas instruments

New technology

The venous blood gas case
Or
How an error became a success

• What do you want to know
within minutes at the
emergency department?

What is a blood gas test?
• Respiration
– pO2, pCO2
• Metabolism
– pH, CO2 metabolites
• Ad-ons:
– Electrolytes – Na, K. Cl, Ca
– Metabolites – Glucose, Lactate
– Blood - Hemoglobin
– Kidney – Creatinine

Venous sample, automatic sample handling
and reporting to LIMS and HIMS
…. Basic biochemistry within minutes

Venous sample, automatic sample handling
and reporting to LIMS and HIMS
…. Basic biochemistry within minutes
POCT introduced at the four
major emergency hospitals
- 200 000 patients/year
Lab provides service at the
smaller hospitals

Venous blood gas analysis
Triage status:
• From error to routine
– 2008 – 2012:
– A ten-fold increase at ED
– 130 000 samples – 1 500 000 results
• 10 % of clin chem production
pH, pCO2, pO2, BE
Na, K, Ca, Cl, creatinine,
Hb, Glucose, Lactate
Venous blood gas analyses 2008
3500
3000
2500
2000
1500
1000
500
0
JANUARI
FEBRUARI
MARS
APRIL
MAJ
JUNI
JULI
AUGUSTI
SEPTEMBER
OKTOBER
NOVEMBER
DECEMBER

Venous blood gas analysis
• From error to routine
– 2008 – 2012:
– A ten-fold increase at ED
– 120 000 samples – 1 000 000 results
• 7 % of clin chem production
Venous blood gas analyses 2008
12000
Income status:
pH, pCO2, BE
Na, K, Ca, creatinine,
Hb, Glucose, Lactate
Creatinine and sodium tests from
ED analysed at central core lab
3500
3000
2500
2000
1500
1000
10000
8000
6000
4000
500
0
2000
JANUARI
FEBRUARI
MARS
APRIL
MAJ
JUNI
JULI
AUGUSTI
SEPTEMBER
OKTOBER
0
NOVEMBER
DECEMBER
2008 2009 2010 2011

Effect of POCT on total lab production
Lab tests also on blood gas analysers
300000
250000
200000
150000
100000
50000
2005
2006
2007
2008
2009
2010
2011
0
Kreat Na K Hb

POCT – Effects on test ordering
Introduction
of venous
blood gases

Quality issues to be handled
• Hemolysis
• Transferability of results
• New middleware for hospital networks
• New diagnostic strategies

Hemolysis
• ”Blood gases are great. No problems with
hemolysis!”
• ED hemolysis rate approx 5 %
– Highest rate in health care
– Larsson and Lundahl 2012
• Continuous preanalytics training
– Highest staff mobility in health care
• New detection method??

ABL helblod
Transferability of results
1.5 million results from ED POCT
Creatinine
y = 0,9968x - 0,0806
R 2 = 0,992
10
Whole blood POCT creatinine -
Plasma lab creatinine
200
150
5
100
0
50
-5
0
0 50 100 150 200
Cobas plasma
-10
0 50 100 150 200 250

Transferability of results
• Acceptable transferability lab – POCT
– Moving target
• As long as whole blood POCT results are
compared to plasma results
• QA
– Controls - matrix
– EQA
• Split sample

Middleware for regional networks
Implementing new POCT – IT system
AQURE from Radiometer
System spanning the whole region
• Requests, results, service, competence, e-learning, QA …
… and all of its 2000 POCT devices
• Blood gas, CRP, Glucose, Hb, HbA1c, coagulation, urine

New diagnostic strategies
• New POCT applications
– The TNT story
– Panels
– Microbiology
– Coagulation
• And getting rid of the old ones
– The neglected aspect

Troponins as POCT
• STAT
• Diagnostic algoritms
• Logistics
• Economy

Troponins as POCT
STAT
Clinical needs:
– POCT to rule-out low probability cases
• One third of cases
– Acute coronary syndrome
• immediate treatment anyway
• Lab TAT: 90 % < 60 min
• POCT TAT: 15-25 min – not 2 minutes!

Troponins as POCT
Diagnostic algoritms
• New diagnostic guidelines based on
high-sensitivity troponin assays
• POCT methods not there …. Yet
• ONE method – ONE decision limit
• Don´t mix two methods in one process!

Simplify and standardise ED biochemistry
Panels for triage
• Liver
• Gastroenterology
• Kidney
• Infection
• Sepsis

And getting rid of the old …
Recommendation to EDs:
• Reduce use:
– AST, D-dimer, Platelets, APTt, Methanol
• Reduce use of combinations:
– AST/ALT, PK/APTt, Ethanol/Methanol

antal
Optimising ED biochemistry
And getting rid of the old ones – AST, APTt, Platelets
1800
1600
ED Malmö 2012 2013
New
recommendations
1400
1200
1000
800
600
Annual ED savings:
90 000 euro
(10 % of clin chem costs)
400
200
0
1 3 5 7 9 11 13 15 17
Month
1. Reduce obsolete tests
2. Optimised panels

The drivers, losers and winners
are…

Drivers
• Economy
– When does POCT really make a difference??
• Guidelines
– And when not to follow?
• Logistics
– The problems are not biochemical
• Relationships
– Lab as consultant and partner

Winners
• Creators of services based on technological
possibilities
– Industry
– Laboratory medicine
• Laboratory medicine as a medical speciality
– Customer relationship and feed back
– Knowledge and understanding

Loosers
• Hard-core lab economists
• Core lab vendors

Take-home-message
• Going from lab workshop to regional service is
different
• Structured, multi-level relationship with
customers
• POCT is an essential tool to improve lab role as
medical partner

From workshop to regional service
And POCT is an essential tool!

Reference:
www.Acutecaretesting.org July 2013
http://acutecaretesting.org/en/articles/a-regional-program-for-poctservice-to-emergency-departments--results-and-remaining-challenges