harmonisation of preanalytical phase in europe · 2017. 11. 21. · ana-maria Šimundi ć...
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Harmonisation of preanalytical phase in Europe
Ana-Maria ŠimundićDepartment of Medical laboratory diagnosticsClinical hospital „Sveti Duh”Zagreb, Croatia
Imagine a world….
Where….
A patient can walk into every lab on Earth and get (almost) the same test results…
This is not possible unless all procedures are…
o reliableo reproducible
throughout the total testing process
Lippi G, Simundic AM, Rodrigues-Manas L, Bossuyt P, Banfi P. Standardizing in vitro diagnostics tasks in clinical trials: a call for action. Ann Transl Med 2016, doi: 10.21037/atm.2016.04.10
Are preanalytical practices comparable?
o between continents?
o between countries?
o between labs?
o between invdividuals?
o large heterogeneity (variations in blood-sampling technique)!
o done mostly by nurses
o phlebotomy is performed by medical and nonmedical personnel (even admin staff)
o different level of knowledge, competence, education and life long training
o few NSs have phlebotomy guidelines (7/28, 25%)
Simundic AM, et al. CCLM 2013; 51(8): 1585–1593
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o Compliance with the CLSI H3-A6 unacceptably low
o The most critical steps were:o patient identification
o tube labelling
o Non compliance leads to errors!
12 European countries
Simundic AM, et al. CCLM 2015;53(9):1321-31
Preanalytical errors
oHarm to the patient
oUnnecessary cost
o Incorrect test results
oUnnecessary delaysDiagnostic errors:o missed diagnosiso delayed diagnosiso misdiagnosis
Graber, M. L. et al. Diagnostic error in internal medicine. Archives of internal medicine. 2005;165
Lippi G, Simundic AM, Rodrigues-Manas L, Bossuyt P, Banfi P. Standardizing in vitro diagnostics tasks in clinical trials: a call for action. Ann Transl Med 2016, doi: 10.21037/atm.2016.04.10
Solution?
Standardization of all procedureswithin the TTP
Formulation, publication, and implementation of guidelines, rules, and specifications for common and repeated use,
aimed at achieving optimum degree of order or uniformity in a given context, discipline, or field.
o the scope of harmonization should include all aspects of the total testing process
o laboratory tests performed by different laboratories at different times on the same sample and specimen should becomparable.
Lippi G, Simundic AM, et al. Standardizing in vitro diagnostics tasks in clinical trials: a call for action. Ann Transl Med 2016;4(9):181.
Plebani M. Harmonization in laboratory medicine: Requests, samples, measurements and reports. Crit Rev Clin Lab Sci. 2016;53(3):184-96.
Standardization throughout thetotal testing process
The role of EFLM WG-PRE?
What have we done so far?
To underline the importance of the proper identification procedure…
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Patient identification and tube labelling- a call for harmonisation
o A minimum 2 and preferably 3 unique identifiers should be used for patient identification;
o Patient and sample identity should always be checked in the presence of the patient;
o Barcoded labels whenever possible
CLSI GP33-A Accuracy in Patient and Sample Identification
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van Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, Nybo M, Simundic AM; Patient identification and tube labelling - a call for harmonisation. CCLM. 2016 Jan 19.
o have zero tolerance to patient ID errors;
o have a policy and a written standard operating procedure for patient and sample identification,
o ensure a continuous education for all professions involved in phlebotomy;
o have a system in place to continuously monitor and reduce the ID error frequency;
Patient identification and tube labelling- a call for harmonisation
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van Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, Nybo M, Simundic AM; Patient identification and tube labelling - a call for harmonisation. CCLM. 2016 Jan 19.
Healthcare institutions should:
o should adopt these recommendations
o Should encourage their implementation among healthcare institutions at their national level;
Patient identification and tube labelling- a call for harmonisation
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van Dongen-Lases EC, Cornes MP, Grankvist K, Ibarz M, Kristensen GB, Lippi G, Nybo M, Simundic AM; Patient identification and tube labelling - a call for harmonisation. CCLM. 2016 Jan 19.
EFLM member societies:
To underline the importance of the proper definition of the fasting state…
WG-PRE recommendation
o Blood should be drawn between 7 to 9 a.m.
o Fasting should last for 12 h
o Water consumption is permitted
o Alcohol should be avoided for 24 h before blood sampling.
o In the morning before blood sampling, patients should refrain from cigarette smoking and caffeine containing drinks (tea, coffee, etc.).
Simundic AM, et al. Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Phase(WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Clin Chim Acta. 2014;432:33-7.
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WG-PRE recommendation
o Professional associations are encouraged to supportstandardized recommendations for fasting
o Laboratories associations are encouraged to adopt the definition of fasting
o Laboratories should have policies for sample acceptance criteria related to fasting samples.
o Definition of fasting should be used in scientific papers.
Simundic AM, et al. Standardization of collection requirements for fasting samples: for the Working Group on Preanalytical Ph ase(WG-PA) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Clin Chim Acta. 2014;432:33-7.
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The effect of different tube additives on blood glucose measurement: systematic overview of the literature.
Lippi G, Nybo M, Cadamuro J, Guimaraes JT, van Dongen-Lases E,
Simundic AM., Adv Clin Chem. 2017; in press
Advances in
Clinical Chemistry
Accepted for publication: 12 Sept 2017 Blood glucose determination: effect of tube additives
Giuseppe Lippi, Mads Nybo, JanneCadamuro, Joao Tiago Guimaraes, Edméevan Dongen-Lases, Ana-Maria Simundic, onbehalf of the European Federation ofClinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).
Adv Clin Chem, in press.
Blood glucose determination: effect of tube additivesGiuseppe Lippi, Mads Nybo, Janne Cadamuro, Joao Tiago Guimaraes, Edmée van Dongen-Lases, Ana-Maria Simundic, on behalf of the European Federation of Clinical Chemistry and LaboratoryMedicine (EFLM) Working Group for Preanalytical Phase (WG-PRE).Adv Clin Chem, in press.
Collaboration on joint guidelines would:o Save the effort for many
o Facilitate implementation across Europe
Linkedin: Pixar Animation: Model for Nonprofit Collaboration
Take the lead and catalyse collaboration on preanalytical issues in Europe
Our role?
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Consensus meeting (March 2015, Porto)o 20/40 EFLM NS have been present
o NSs have presented their their activities at the national level
(10 min PPT)
o interactive panel discussion
o The aim was to share views about necessity and the possibility
of harmonization of preanalytical phase across Europe.
Cornes MP, Church S, van Dongen-Lases E, Grankvist K, Guimarães JT, Ibarz M, Kovalevskaya S, Kristensen GB, Lippi G, Nybo M, Sprongl L, SumaracZ, Simundic A. The role of EFLM WG-PRE in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem 2016 May 1.
What have we learned?
o there has been a rapid growth in the number of NS with preanalytical working group, in the past several years
o in 2015 there are at least 19 countries in Europe that have a preanalytical working group
1995 --> Germany.
M
1998 --> Spain.
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M
2005 --> Italy.
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2012 --> Netherlands and Croatia.
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2013 --> Austria and UK 2014 --> France, Serbia, Russia, Denmark, Finland, Iceland, Norway, Sweden, Lithuania, Turkey, Macedonia, Czech Republic
NS representatives20-21 March 2015, Porto
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Název osy
Surveys?
Guidelines in progress or planned?
How many guidelines?
NS activities
Cornes MP, Church S, van Dongen-Lases E, Grankvist K, Guimarães JT, Ibarz M, Kovalevskaya S, Kristensen GB, Lippi G, Nybo M, Sprongl L, SumaracZ, Simundic A. The role of EFLM WG-PRE in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem 2016 May 1.
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EFLM Consensus statement (2015, Porto)
Harmonization of preanalytical phase policies andpractices is possible and necessary:◦ at national level in each individual country in Europe◦ at international level
EFLM NS are willing to work with EFLM to:◦ harmonize preanalytical phase in Europe
◦ develop and implement preanalytical guidelines and recommendations
Cornes MP, Church S, van Dongen-Lases E, Grankvist K, Guimarães JT, Ibarz M, Kovalevskaya S, Kristensen GB, Lippi G, Nybo M, Sprongl L, SumaracZ, Simundic A. The role of EFLM WG-PRE in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem 2016 May 1.
Key preanalytical issues identified which require urgent harmonization
0 2 4 6 8 10 12 14 16 18
Paediatric and neonatal sampling
Patient Identification
Quality Indicators
Management of unsuitable specimens
Sampling
Patient Preparation
Transport and storage
Test ordering
Cornes MP, Church S, van Dongen-Lases E, Grankvist K, Guimarães JT, Ibarz M, Kovalevskaya S, Kristensen GB, Lippi G, Nybo M, Sprongl L, SumaracZ, Simundic A. The role of EFLM WG-PRE in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem 2016 May 1.
Simundic AM, Bolenius K, Cadamuro J, Cornes MP, van Dongen-Lases EC, EkerP, Grankvist K, Guimaraes JT, Ibarz M, Kovalevskaya S, Kristensen GBB, Lippi G,
Nybo M, Sumarac Z, Erdeljanovic T, Church S, Ivanov H,
on behalf of the Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).
EFLM WG-PRE European recommendation for
venous blood sampling
13 countries represented
Harmonization of venous blood sampling thorughout Europe
What makes our document different from other docs?
EFLM EG-PRE recommendation:o is evidence based
o evidence is graded (quality of evidence and associated risk are
assessed for each step)
o offers guidance for sucessful implementation
o Gives you tools to assist you in implementation
o is free
o shall be translated to local languages
Accompanying tools
o Knowledge test
o Checklist
o PPT presentation
o Posters
o Videos
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EFLM-Colabiocli MoU
Signed in October 2017
EFLM-Colabiocli joint
recommendation for venous blood
sampling
Confederación Latinoamericana de Bioquímica Clínica (COLABIOCLI).
European Federation of Clinical Chemistry and Laboratory Medicine
Ana-Maria SIMUNDIC Chair Croatia 3rd term: 2017-2018
Giuseppe LIPPI Member Italy 3rd term: 2017-2018
Kjell GRANKVIST Member Sweden 3rd term: 2017-2018
Mads NYBO Member Denmark 3rd term: 2017-2018
Michael CORNES Member-Young Scientist UK 3rd term: 2017-2018
Barbara DE LA SALLE EQALM Representative UK -
Gunn B. B. KRISTENSEN EQALM Representative Norway -
Janne CADAMURO Corresponding Member Austria 1st term: 2016-2017
Pinar EKER Corresponding Member Turkey 3rd term: 2017-2018
João T. GUIMARAES Corresponding Member Portugal 2ns term: 2016-2017
Mercedes IBARZ Corresponding Member Spain 2ns term: 2016-2017
Svetlana KOVALEVSKAYA Corresponding Member Russia 3rd term: 2017-2018
Gunn B. B. KRISTENSEN Corresponding Member Norway 3rd term: 2017-2018
Ludek SPRONGL Corresponding Member Czech Rep. 3rd term: 2017-2018
Zorica SUMARAC Corresponding Member Serbia 3rd term: 2017-2018
Edmée van DONGEN-LASES Corresponding Member The Netherlands 3rd term: 2017-2018
Alexander von MEYER Corresponding Member Germany 1st term: 2017-2018
Pieter VERMEERSCH Corresponding Member Belgium 1st term: 2017-2018
Stephen CHURCH Expert/Consultant Becton Dickinson -
Rubén GOMEZ RIOJA Expert/Consultant Spain -
Christa SEIPELT Expert/Consultant Sarsdedt -
Pedro GUEDES Expert/Consultant maksense Indexor -
Maxim GORBATSEVICH Expert/Consultant Viena Medical -
Helene IVANOV Expert/Consultant Greiner24
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Ongoing projects & future plans
Large WG, 24 memberFocus groups
Key preanalytical issues identified which require urgent harmonization
0 2 4 6 8 10 12 14 16 18
Paediatric and neonatal sampling
Patient Identification
Quality Indicators
Management of unsuitable specimens
Sampling
Patient Preparation
Transport and storage
Test ordering
Cornes MP, Church S, van Dongen-Lases E, Grankvist K, Guimarães JT, Ibarz M, Kovalevskaya S, Kristensen GB, Lippi G, Nybo M, Sprongl L, SumaracZ, Simundic A. The role of EFLM WG-PRE in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem 2016 May 1.
Demand management
o Background: not known what demand management strategies are in use inEuropean labs; demand management not recognised by clinicians as theresponsibility of the laboratory
o Aim: o To launch a survey about what demand management strategies are in use in Europe
o To launch a survey addressed to clinicians and health managers about what should be the laboratory role in demand management and how laboratory could help them.
o opinion paper about the Medical Laboratory role in demand management
Zorica Sumarac Mads Nybo JanneCadamuro
Joao TiagoGuimaraes
Michael Cornes
PieterVeermersch
SvetlanaKovalevskaya
Mercedes Ibarz
Stabilitystudies
o Background: stability studies not done in the same way;
o Aim: o to develop a standard for stability experiments in the clinical setting
o to propose a checklist for critical appraisal of stability studies
o to build a EFLM stability database
AACCSpanish socitey of LMLatin-American WG-PRE
Mads Nybo Gunn BB Kristensen
Janne Cadamuro Alexander von Meyer
Michael Cornes
o Background: large variations in the way labs detect HIL indices andmanage unsuitable samples
o Aim: o To assess how laboratories in Europe detect and manage unsuitable samples
o To propose recommendations.
o Project started in 2015, ongoing – planned end date – end of 2018
Janne Cadamuro
Unsuitable samples
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Recommendations
o Lippi G, Cadamuro J, von Meyer A, Simundic AM. Practical recommendations for managing hemolyzed samples in clinical chemistry testing (Opinion paper, Type III document)
o von Meyer A, Cadamuro J, Lippi G, Simundic AM. Call for more transparency in manufacturers declarations on serum indices. (Opinion paper, Type III document)
both documents are submitted to EFLM C-S chair for comments and endorsement
European survey on unsuitable samples
o aim: to assess how labs in Europe detect and manage unsuitable samples
o done in collaboration with EQALMo survey launched mid September and closed by the end
of Novembero 1300 completed answers collected so faro survey open until the end of November
Blood sampling through catheters
o Background: blood sampling through catheters not standardized, largevariations
o Aim: o Perform observational study to assess the quality of sampling through catheterso Perform a survey to assess the nurses’ knowledge and awarenesso Produce recommendation
o Project ongoing – planned end date – end of 2018
Mads Nybo Pinar EkerJanne Cadamuro Kjell Grankvist Stephen Church
Zorica Sumarac
Tube validation
o Background: Tube validation not done, or not done in the same way (CLSI not widely available; CLSI not free)
o Aim:
o produce EFLM recommendation for tube validation
o produce EFLM tools (checklist and Excel chart, recommendation on statistical methods and performance criteria)
Edmee van Dongen Lases
Awareness raising campaign
o Background: Not all healthcare professionals are aware of the importance of the preanalytical phase
o Aim:
o To raise the awareness of hospital professionals and phlebotomists of the importance of the preanalytical phase in laboratory results
o To produce a resource focusing on the quality of blood specimens (e.g. Website hosted by EFLM, App, Social media campaign, etc.)
Mercedes Ibarz Zorica Sumarac StephenChurch
Helene Ivanov
Michael CornesThanks to…..
o EFLM Executive Board
o National Societies
o Laboratory professionals throughout Europe
o Companies (BD, Greiner, Sarstedt, Maksense)
o WG-PRE members for their hard work
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@ recent WG-PRE meeting in MunichThursday, 9 November 2017 (9:00 – 18:00)
Team is the key
o Zorica Sumarac (Title: EFLM WG-PRE venous blood sampling project), date: 27 January 2018
o Tiago Guimaraes (Title: How to perform tube validation?), date: March 2018
o Michael Cornes (Title: The order of draw), date: May 2018
o Stephen Church (Title: Catheter collection), date: September 2018
o Pieter Vermersch (Title: Pre-analytical mysteries), date: November 2018
more WG-PRE webinars: