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Recent Changes and Controversies
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4th Edition - Minimising Airborne Contamination
B2.1 “ there shall be a designated inpatient unit that minimises airborne microbial contamination
B2.2 “ designated outpatient area......”
Standards now recognise
• Variation in unit facilities – number, case mix, prevalence of opportunistic infections
• Increased use of ambulatory approaches with frequent day case review
• Do not imply that all units must have LAF
• Important to provide data on effectiveness of approaches used
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4th Edition - Admission to Intensive Care
• B2.1.1 “The in-patient program shall have an intensive care unit or equivalent coverage within the institution”
• B2.2.1 “Outpatients shall have a plan for providing immediate access.....”
• Covers both inpatient programmes and outpatient facilities
• Arrangements must be documented
• IP within the facility; OP not necessarily on-site
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MTX/CsA GVH prevention
ATG
0d-7
months
NK
T CD8+, B
T CD4+HSC infusion
isolation
bacteria
Candida aspergillus
HSV
CMCCMV, EBV, adenovirus, VZV
0 1 2 3 4 5 months
Acute GVH treatment
MainOpportunisticinfections
conditioningTBI
6 9 12
1 3
Discharge - Period of Time Covered by Standards?
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Planned Discharge to Referral Centre
• B2.3.5 “Planned discharge shall be to facilities adequate for post-transplant care. The CP is responsible for ensuring that the receiving centre provides care that meets applicable standards”
• What is the limit for this – d30 auto; d100 allo ?
• Responsibility of the TC to ensure compliance with items such as - Isolation facilities– Staffing and training– Policies and procedures
• JACIE will require documentation of compliance and may include inspection of the hospital providing post-transplant care
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Outpatient Facilities
• B2.3 “There shall be a designated area for outpatients.....” protect from infections and allow appropriate isolation, administration of IV fluids, medications and/or blood products
• Deficits include lack of space to allow proper segregation of patients with significant infections
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4th Edition - Collection Facility Director
• C3.2.1 “there shall be a collection facility director who is an individual with a medical degree or a degree in a relevant science”
- requirement for a PhD dropped
- Allows more nurses to become CFD
- Emphasis also on postgraduate training and experience
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4th Edition - Collection Facility Other changes
• Donor section harmonised with B6
• Labels – clear legible and use ink that’s indelible to all relevant agents
• Labels – also include concurrent plasma and samples – assigned the same identifier
• Biohazard, warning and completion of collection labels – all info removed to table at Appendix 1.
• C7.8 Accompanying docs at end of collection applies only to products collected in the USA or designated for use in the USA e.g. statements of ‘donor eligibility’
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ABO testing and Compatibility
• B6.3 “allogeneic CTPs; a test for ABO group and Rh type shall be performed on the first product collected or on blood obtained from the donor at the time of first collection”
• Testing requirement for allogeneic donors on each and auto donors on 1st day of collection removed
• Guidance: (i) document donor and recipient ABO/Rh prior to collection (ii) SOPs to manage ABO mismatch should be established
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4th Edition - What is a Clinical Programme?
• Clinical Standards cover cell therapy at present mainly HSCT, C and D refer to cellular therapy
• B1.1 “ an integrated medical team housed in geographically contiguous or proximate space with clinical programme director(s) and common staff training programmes, protocols and QMS”
• Non-contiguous sites must be in defined networks - community programme with 2 hospitals in
the same area - NHS Trust in the UK - Cancer networks - other robust structures involving
centres/satellites• Units should be , 1 hour travelling time
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Areas of deficiencies Expressed as % of total deficiencies. Based on analysis of 1732 deficiencies encountered in inspections
0% 5% 10% 15% 20%
Quality Management
Policies & Procedures
Labels
Doner Selection, Evaluation & Management
Personnel
Storage
Records
Facilities
Cell Collection
Distribution
Receipt & Transport
Therapy Administration
Process Controls
Data Management
General
Disposal
Research
Cat
ego
ry
% of total deficiencies
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Minor v Significant Deficiencies
Difference between a minor deficiency and a significant deficiency is a matter of judgement
Minor deficiencies generally involve correction to
existing SOPs or other documentation Significant deficiencies - examples
Inpatient isolation facilities inadequate
No continuous temperature monitoring of freezers
Inadequate quality management programme
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Interactions Between Facilities
• Collection facility must use processing facilities that meet JACIE standards
• Bone marrow collection normally integral to clinical programme but must be inspected and accredited as a collection facility
• Apheresis collection and processing facilities may be integral to programme, or external, e.g. National Transfusion Service
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Interactions Between Facilities
Links between facilities are important e.g. – Written requests for
collection, or component issue
– Provision of engraftment data to collection and processing facilities
– Reporting of AE’s to other facilities, if appropriate
– Service agreements or contracts with external facilities
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At the end of the inspection
The exit interview
– Inspector should discuss any sensitive issues with facility head and/or Programme Director in private BEFORE exit interview
– The inspectors discuss their visit and inform the Programme Director and staff of what they found
– Inspectors do not comment on possible outcome
– Inspectors should not express personal opinions about standards
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Reporting after the Inspection
• Complete checklists with reasons where required
• List key personnel
• Short report summarising structure and operation of collection facility
• Send to team leader promptly!!
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Inspection report
Corresponds with the exit interview
i.e. no surprises
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The Inspector
• Inspectors return Completed Inspection Checklist, any notes and documents to the Team Leader (TL) or directly to JACIE Office
• TL compiles summary inspection report based on discussions with the other inspectors and their observations
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Reporting13b. Median days from audit to receipt of report
23 23 23
60
95
7876
111
146
112
87
62
42
3844
0
20
40
60
80
100
120
140
160
2004 2005 2006 2007
Da
ys
0
5
10
15
20
25
30
35
40
Ins
pe
cti
on
s
Inspections per year 1. From audit to inspection report
2. With JACIE Office 3. Audit to Summary Report
Days to submit Inspection Reports by inspectors
25%10%
33%21% 18% 22%
42%
25%
33%41%
22% 22%
33%
65%
33% 38%
59% 56%
0%
20%
40%
60%
80%
100%
2004 2005 2006 2007 2008 2009
Year inspected
? 14 days 15-30 days >30 days
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Confidentialty
• Inspectors should not discuss inspection with colleagues
• Return any documents or notes to Team Leader or JACIE Office– Inspector can ask centre for
permission to use and SOPs, labels etc.
– Applicant centre is entitled to refuse
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Summary
• Be aware of new standards• Read documentation
thoroughly before visit• Decide who to speak to on
the day and on points to clarify
• Ask members of collection facility staff to show you what they do
• Be interested, kind, supportive and patient!!
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Thank You