jacie in europe: current situation & future - · pdf filejacie in europe: current...

JACIE in Europe: current situation & future

1

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

13

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.

17

*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)

31

– Not Applicable (N/A)

• Includes Evidence and Examples

• IMPORTANT: Include additional information, explanations, references to documents, etc

Inspector’scomments

32

• Labels• Quality Manual• List of SOPs• Donor / patient consent

Pre-inspection documentation

33

• 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??!!?

.

.

Email

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 help@jacie.org• 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?

75