Experience of JACIE in a Large BMT Unit

1
Experience of JACIE in a Large BMT Unit

• Dr Jenny Byrne
• Nottingham City Hospital

2
Nottingham BMT Programme

• Programme Director
• Prof NH Russell
• Transplant Consultants
• Dr J Byrne
• (Dr EP Das-Gupta)
• Dr AP Haynes / Dr AK McMillan (lymphoma PBSCT)
• Clinical Programme
• approx 130 transplants / yr (40 allogeneic)
• Apheresis unit
• 270 PBSC aphereses / yr
• Stem Cell Processing Laboratory
• gt 300 products processed / yr

3
Rationale for Early JACIE Accreditation

• Prof NH Russell attended JACIE inspector training
  course in March 2001
• Quality Management structure set up in April 2001
• Successful stem cell laboratory MHRA inspection
  in 2002
• Dr J Byrne attended JACIE Training course Sept
  2002
• Inspections to roll out in UK in 2004
• Aim to get it over with
• Cheaper! (EU grant in 2004)

4
Quality Management Programme

• Essential component for JACIE accreditation
• Need evidence to show operational for at least 12
  months prior to inspection
• Designated quality Manager required to
• Write Quality Management Plan
• Monitor quality of transplant programme eg
  audits, outcome parameters
• Coordinating actions required to implement the
  system
• Report progress and current situation regularly
• Detecting, evaluating and reporting errors and
  implementing corrective actions
• Document control and ensuring SOPs updated

5
Objectives of the Quality Management Programme

• Ultimate goal of quality assurance is to control
  processes so that quality is built into the
  service that is delivered
• Primary objective of the Quality Management
  Programme is to ensure that all aspects of the
  Transplant Programme conform to established
  standards
• Provide evidence that all systems and procedures
  that influence quality are working as expected
  with the aim of preventing errors

6
Requirements Of The Quality Management Programme

• Each Transplant Unit must have a Quality
  Management Plan outlining how it will implement
  its quality assurance activities
• Must be a designated person to oversee the
  quality programme
• may be an external quality manager or a member of
  the Transplant team (need sufficient knowledge to
  identify problems in the processes under review)
• Must include all aspects of the transplantation
  service including stem cell collection
  processing

7
Nottingham Quality Management Team

• No funding available for dedicated Quality
  Manager
• Quality Management duties written into job
  descriptions of selected staff members
• Overall Quality Manager
• Dr JL Byrne
• Delegated Quality Officers
• Stem cell laboratory quality officer
• Stem cell collection quality officer
• Clinical transplantation service quality officer
• Ownership of transplant programme and QM
  culture developed

8
Duties Of The Quality Management Team

• Maintain and review SOPs / protocols for all
  routine procedures and ensure that these comply
  with established standards
• Carry out quality audits to ensure that protocols
  and SOPs are adhered to
• Report and investigate any adverse events or
  near-miss errors on Variance Forms including
  adverse reactions to progenitor cells
• Ensure that staff are adequately trained in all
  procedures and that their competency and
  proficiency is tested
• Ensure that research protocols are approved and
  monitored

9
Quality Management Meetings

• Monthly meetings
• Chaired by Dr JL Byrne
• Membership
• Quality officers from all 3 areas
• Programme Director
• Transplant physicians
• Pharmacist
• Blood Bank Chief
• Infection control officer
• Hospital Clinical Governance representative

10
Quality Management Agenda

• Stem Cell Laboratory Issues
• Variance forms / adverse events
• SOPs, staffing training issues, activity,
  facilities
• Stem Cell Collection Issues
• Adverse events / deviation from SOPs
• Staffing, facilities, SOPs, pt information
  feedback
• Clinical Issues
• Staffing issues, facilities, activity rates,
  infection rates, pharmacy issues, blood
  transfusion issues
• Clinical guidelines / protocols, pt information
• Incident forms, TRMs, Grade 3-4 toxicities
• Audits / Outcome Data

11
JACIE Preparations in Nottingham

• Accreditation applied for Jan 04
• January 2004, Nottingham JACIE workforce group
  established
• Representatives from all 3 sections of transplant
  programme invited
• Regular fortnightly meetings
• Review of each standard and evidence of
  compliance collected
• If necessary new documents written / updated
• Secretary commandeered to gather evidence and
  convert to electronic format

12
JACIE Preparations (cont)

• June 2004 all evidence collected
• End June electronic submission of all evidence
• Slight delay over summer period
• Inspection date finally set for Oct 2004
• JACIE workforce meetings continue
• to check all SOPs in date
• collect clinical notes and check necessary data
  filed and easy to find
• gather together all necessary documentation
• ensure all staff aware

13
Inspection Oct 2004

• 2 day schedule planned
• 3 inspectors
• 1 clinical programme
• 1 collection facility
• 1 processing facility
• (1 observer)
• Documents required
• Notes for 10 autografts and 10 allografts
• SOPs for clinical / collection / processing areas
• Staff training and competencies
• Quality documents / audits etc

14
Timetable

• Day 1
• Am Welcome and Structure and Organisation of
  BMT programme
• Introduction to key staff members
• Document review
• Pm Guided visits of inspectors to specific
  areas to complete checklist
• View procedure eg cell return, apheresis,
• freeze
• Interview staff members, eg pharmacist
• Request documents eg SOP for stem cell
• infusion, consent form for trials

15
Timetable (cont)

• Day 2
• Am Complete document review
• Interview staff members eg quality
• manager, microbiology Consultant
• LUNCH
• Pm Meet privately with Programme Director
• Exit Interview all staff invited
• Summarise findings, feedback positives,
  negatives

16
Post Inspection Issues

• Level 2 accreditation awarded
• Few points to address
• Clinical programme
• Modify bone marrow harvest SOP
• Stem Cell Collection facility
• New SOP to cover transportation from apheresis
  unit to laboratory
• Stem Cell Laboratory
• Modify 1 label
• Put in worked examples in SOPs
• Cross reference SOPs
• Add references to SOPs

17
Timeline
Prepare for accreditation
6-18 m
April 01
-3-6 m
Jan 04
Submit application
-3 m
Jun 04
Submit documentation
Oct 04
INSPECTION
0
Max 2 m
Jan 05
Report from JACIE
Correct deficiencies/ submit evidence
Max 12 m
Feb 05
Final JACIE Report Recommendation to Board
April 05
Max 2 m
ACCREDITATION
3 yrs
April 05
18
JACIE On Line

• Useful web-site
• Examples of quality management plans and
  documents available Dec 05
• CV Template for Transplant personnel
• List of accreditation deficiencies
• 3rd Edition of JACIE standards available Jan 06
  (30 day public consultation)
• Discussion forum
• All documents available electronically
• JACIE Surveys (presented in Prague 2005)

19
JACIE Survey of Centre Results1 Motivation

• What was your motivation for applying for JACIE
  Accreditation?

20
Survey of CentresResults2 Personnel

• Was there a person responsible for day-to-day
  management of the process apart from the
  Programme Director?
• Was this person employed full-time or part-time?
• Was this person a trained expert in quality
  management?
• Was this person part of your team or was it an
  external person?

21
Survey of CentresResults3 Difficulties

• Which of the following areas presented the most
  difficulties in preparing for accreditation?
• What were the most difficult parts of your
  preparations?

22
Survey of CentresResults4 Difficulties (cont)

• What levels of difficulty did you experience in
  the following?

23
Survey of CentresResults5 Training

• Did you or any member of your team attend any
  JACIE-specific training?
• If yes, how much did this training help?

24
Survey of CentresResults6 Resources

• What extra resources
• were required specifically
• to implement JACIE?
• What financial support
• did your programme receive,
• if any?

25
Survey of CentresResults7 Satisfaction

• Were you satisfied with the manner in which your
  centre was inspected?
• Please rate the inspection team that visited your
  centre
• Do you consider that the inspection was fair and
  objective?
• How would you rate the quality of the inspection?

26
Survey of CentresSummary Statement

• How satisfied are you with the overall
  accreditation process?
• How satisfied are you with the support received
  from the JACIE Office?
• Is accreditation worth the effort?