JACIE in Europe: current situation & future...No. Teambox is ‘in the cloud’ so you just need a...
Transcript of JACIE in Europe: current situation & future...No. Teambox is ‘in the cloud’ so you just need a...
JACIE in Europe: current situation & future
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Eoin McGrathJACIE Office,
Barcelona, Spain
Aims
• Current state of JACIE• Accreditation process• Some more general thoughts• Future challenges• Future challenges• Practical aspects• Questions
JACIE Overview
Where is JACIE today?
• Europe • Middle East
Also recently,South Africa, Singapore & Portugal
JACIE Initial & Reaccreditation applications per ye ar
36 3629
44
23
12
16
18
1323
20
30
40
50
60
23
0
10
2008 2009 2010 2011 2012
Initial Reaccreditation
Completed inspections per year
30 31
513
2215
20
30
40
50
60
1
1818
30 31
00
10
2009 2010 2011 2012 2013
Initial Reaccreditation
JACIE awarded accreditations by year
15
5 15
2
39
5
10
20
30
40
50
27 22 22 310
10
2008 2009 2010 2011 2012
Initial Reaccreditation
% distribution of total initial applications by country
Sw itzerland3,7%Belgium
5,0%
Spain7,0%
Netherlands7,7%
France12,8%
Sw eden1,7%
Greece1,3%
Turkey1,0%
Czech Republic1,0%
Poland0,3%
Israel0,7%
Austria1,0%
Finland1,0%
Portugal0,3%
Italy20,5%United Kingdom
19,1%
Germany14,4%
Norw ay0,3%
South Africa0,3%
Singapore0,3%
Saudi Arabia0,3%
Why JACIE?
• Legal requirement in some countries
• Health insurance companies require it
• Social insurance system requires it
Why JACIE?
• Competition with other centres
• Professional pride• Professional pride
• Improved outcome forpatients
Some real examples of benefits
• Adult / Paediatric programme - made our 2 transplant units work together.
• Made the nurses talk to each other, have a common education programme
• Provided a mechanism for investigating major issues in the stem cell lab
• Provided a mechanism for investigating major issues in the stem cell lab
• Made us do things in a safe, reproducible and evaluable way esp. with new staff
• Makes us do audit• Improved safety of medical and nursing
coordination. Helped us get appropriate staff levels
Examples from Prof. D. Marks, Bristol BMT Unit, UK
Some real examples of benefits
• Improved communication both internally and externally
• SOP's as valuable information and training resource
• QM meetings allowing detailed internal discussion of adverse events leading to
• QM meetings allowing detailed internal discussion of adverse events leading to corrective action
• Proactive system identifying potential for adverse events before they occur and implementing actions to prevent them
• Standardised practice throughout programme
Examples from Prof. D. Marks, Bristol BMT Unit, UK
JACIE & Health AuthoritiesRegulations• Belgium• France• Switzerland• Italy• The NetherlandsGuidelines• European Directorate for the Quality of Medicines & HealthCare Guide to
the Safety and quality assurance for the transplantation of organs, tissues
www.jacie.org/about/national-regulations
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the Safety and quality assurance for the transplantation of organs, tissues and cells, 4th edition (2010)
• Italy Piano Oncologico Nazionale 2010-2012 cites JACIE accreditation• United Kingdom
– NICE guidelines Improving Outcomes in Haematological Cancers– The Future of Unrelated Donor Stem Cell Transplantation in the UK. A Report from
the UK Stem Cell Strategic Forum (July 2010). NHSBT– JACIE cited in Specialised Services National Definitions Set (3rd edition) SSNDS
Definition No.2, Specialised Services for Blood and Marrow Transplantation (all ages)
Collaboration with regulators• Italy Centro Nazionale de Trapianti (CNT) coordinates inspections of Italian
centres with JACIE through GITMO.
Clinical trials
• Production of cell-based medicinal products by academic facilities rather than by pharmaceutical companies
• Non-conventional use of cytotoxic
Why JACIE?
• Non-conventional use of cytotoxic and immune-suppre ssive drugs
• Complex therapeutic procedure
Why JACIE?
• Collaboration between departments/service is critical
• Increasing use of unrelated donors with international exchanges of cellular products
Impact on survival• Gratwohl, A. et al.
Introduction of a Quality Management System and Outcome After Hematopoietic Hematopoietic Stem-Cell Transplantation.
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*Gratwohl, A. et al. Journal of clinical oncology : official journal of theerican Society of Clinical Oncology 1-7(2011).doi:10.1200/JCO.2010.30.4121
Phases
Process
Decision to work according to the Standards
Process
Preparations, working with quality
Decision to work according to the Standards
Process
Preparations, working with quality
Request inspection
Decision to work according to the Standards
Process
Inspection
Preparations, working with quality
Request inspection
Decision to work according to the Standards
Process
Inspection
Corrections
Preparations, working with quality
Request inspection
Decision to work according to the Standards
Process
Inspection
Accreditation
Corrections
Decision to work according to the Standards
Preparations, working with quality
Request inspection
Inspection
Accreditation
Make changes
Keep going!
AFTER
Inspection
Self-check
Preparation
Decision
BEFORE
Apply
Preparation by the centre
Application
JACIE Office
Application + Checklist
Application Approved
Clarification of Doubts betwen JACIE and centre
Inspection Checklist
Inspection Checklist
• Based on Traffic Light system– Compliant– Partially Compliant– Non-compliant– Not Applicable (N/A)
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– Not Applicable (N/A)
• Includes Evidence and Examples
• IMPORTANT: Include additional information, explanations, references to documents, etc
Inspector’scomments
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• Labels• Quality Manual• List of SOPs• Donor / patient consent
Pre-inspection documentation
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• Donor / patient consent information
• Evidence of qualifications• Evidence of audits performed• Etc.
Conflicts of Interest• Inspector and Centre must
advise of any potential conflicts of interest, such as:– Previously worked in the centre– Previously worked in the centre– Will be working in that centre– Has directly assisted centre with
preparations
Inspection Team
PAEDIATRIC CLINICAL
UNIT
APHERESIS UNIT
ADULTCLINICAL
UNIT
APHERESIS UNIT
PROCESSING UNIT
Inspection Team• 1 team leader
In addition, possible inclusion of:inclusion of:
–Observer e.g. JACIE National Representative, regulatory agency
–Trainee
Feedback from the centres
EvaluationsAPPLICANTS INSPECTORS
Accreditation• Accreditation for 4 years from date of
award– If a centre takes more than 12 months
to resolve deficiencies, JACIE may award accreditation from date of award accreditation from date of inspection
• Interim audit at end of year 2 of accreditation
Interim audit• At end of year 2 of accreditation• Centre notified in advance of visit of the
Clinical Part.• On-site visit will focus on how the quality
management system is functioning– Evidence of audits– QM meetings– SOP review– Etc.
• Based on standards i.e. no new requirements
• At the discretion of JACIE, inspector may also look at issues that were corrected after the previous inspection
More general thoughts
Based on quality management literature
Are we wasting our time?
“The research evidence generally presents health service accreditation as a useful tool to stimulate improvement in health service organisations and promote service organisations and promote high quality organisational processes”
Hinchcliff et al. Narrative systhesis of heath service accreditation literative. BMJ Qual Health2012;21:979-991
• Limitations of the study and evidence but on balance, accreditation is a good thing
• More study needed on• More study needed on– Clinical outcome– Financial aspects
Are we doing the right thing?
“…the most important single condition for success in quality management is the determination to make it work.
If we are truly committed to quality, almost any reasonable method will almost any reasonable method will work.
If we are not, the most elegantly constructed of mechanisms will fail”
Donabedian, A. The Effectiveness of Quality Assurance. Intl J. Quality in Health Care, vol 8, 4. pp 401-407. 1996
“determination to make it work”
• “Nothing [reveals the] marginality of quality assurance … in an organisation more that its being delegated to persons of relatively delegated to persons of relatively little authority … or done in one’s own free time”
• Donabedian, A. The Effectiveness of Quality Assurance.
Clinicians
“If clinicians do not respond to the …calls to make the measurement of quality a core part of their…activities and ethos, part of their…activities and ethos, ….[they] risk being seen as part of the problem”
Mountfield, Shojania. Refocusing quality measurement to best. support quality improvement: local ownership of quality measurement by clinicians. BMJ Qual Saf2012;21:519-523
Interactions/collaboration
clinicalGood interaction can mean more sucessful quality
Fundamental part of FACT-JACIEStandards
processingcollection
quality management collaborations
Hulscher MEJL, et al. Quality and Safety in Health Care 2013;22:19-31
Interactions/collaboration
• “Teams with members whounderstood one another’sstrengths and weaknesses, hadmutual respect, high perceivedmutual respect, high perceivedteam effectiveness … and hadworked as a team previouslywere more successful.
Hulscher MEJL, et al. Quality and Safety in Health Care 2013;22:19-31
Interactions/collaboration
• Essential aspect of FACT-JACIE Standards
• Good interaction can mean more sucessful quality management sucessful quality management collaborations
Future of JACIE
Present
Fred Hutchinson Cancer Research Center, www.fhcrc.org
Future challenges
• Evolving regulations• Workload for centres in meeting
different regulations/certifications/accreditregulations/certifications/accreditations/licenses/insurance criteria/etc. etc. etc.
Future challenges
• Demonstrating value– Justify costs in current economic
climate
• Education• Education
Future challenges
• JACIE has come along way on goodwill – sustainable?– Increasing professionalisation
necessarynecessary– Accreditation/certification of JACIE
as an organisation– Legal aspects
Future challenges
• Attracting and retaining volunteers– Inspectors– Board– Board– Committee members
Future challenges
• Take-up outside western Europe– Central & Eastern Europe– Asia– Middle East– Middle East– Africa– South America
Future challenges
• Changes in healthcare organisations and how care is delivered– Ambulatory– Ambulatory– Clinical leadership– Autonomy of care staff
Future challenges
• Evolution of cellular therapy– Advanced therapeutical medicinal
products (ATMPs)– ECP– ECP
More updates
HELP!
• Subscribe to our mailing listwww.jacie.org/subscribe
– Subscribers will receive periodical JACIE updates and news items. All subscribers can easily update their details or unsubscribe from the list at any time.
– If the address is already in our system, you will see a message "[your email] is already subscribed to list [list name]".
LinkedIn Inspectors’ Forum
www.linkedin.com/groups/JACIE-Inspectors-Forum-4646920/aboutInspectors-Forum-4646920/about
Teambox: Online support tool for
Centres & InspectorsThe Quick Guide for JACIE
Users of Teambox
Centre applies Users: centre, inspectors
+ =
Hotel + travel booking + files +contact details + important instructions
+ expenses forms + ……
Inspector: WHERE is that email with mobile numbers??!!?
.
.
Has the report arrived?When was the checklist returned?Remind the inspectors to return expenses
+ ++ +
??
CURRENT SYSTEM
Who has to book the hotel?When is the report due?Who is resposible for sending the report?When is the report due to be sent?
??
Remind the inspectors to return expensesBook a meeting room for the inspectors
Who has to book the hotel? Us?Did they receive the CD with the files?What do we need to do before the inspection?…
??
It’s all in the Inspection Guide…but its 100 pages long! �
Centre applies
JACIE creates account
Upload & access files
Users: centre, inspectors assigned access
Users access online
NEW SYSTEM
See tasks
Find information
Communicate
Everything online in one place
What will Teambox do for me?for me?
2 key things Teambox does for JACIE
1. An online ‘to-do’ list for every step of the Accreditation Process
1. Auto reminders
2. A single place to find all files and correspondence about an inspection
– No more looking for emails/attachments
– Tasks clearly laid out– Transparent
This is what Teambox does for Inspectors & Centres
Inspectors• All steps in the
process fully listed
• All information
Centres• All steps in the
process fully listed
• All information • All information online in one place
• Tasks assigned to individuals
• Full tracking of all dates, deadlines, etc.
• All information online in one place
• Transparent –who did what and when
Will it make my life easier?
• Yes. Teambox will save time:– Looking for communications– Distributing files, reports, forms,
etc.etc.– No more forgetting – auto
reminders of uncompleted tasks
Do I have to install anything on my computer?
No. Teambox is ‘in the cloud’ so you just need a computer connected to the internet to use the system. There is also a mobile version for iPhone and iPad
It works best in navigators/browsers such as Google Chrome or Firefox so if possible use these.
If you use Internet Explorer, when you log-in to Teambox you might be asked to download Google Chrome Frame to allow Teambox to work. This just takes a moment and allows Teambox to function perfectly in Internet Explorer. Google Chrome Frame is available for Internet Explorer 6, 7, 8 and 9 on Windows 7 / Vista / XP SP2 or greater.
www.google.com/chromeframe/
If I still need help?
• Send an email to [email protected]• Telephone +34 93 453 8711
Mon-Fri 09:00-17:00
6th ed. Standards
• Kick-off process June 2013• Public consultation mid-2014• Release approx. March 2015
Training & events
• EBMT 2013, London– Quality Management Day, Tuesday
9th April
• Inspector Training Course, • Inspector Training Course, – October 2013 Barcelona
“If you do not design the future someone or something else will something else will design it for you”
Edward de Bono(Malta 1933)
Physician, author, inventor, and consultantOriginated the term ‘lateral thinking’
• Thank you for listening• Any questions?
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