Transcript JACIE Inspector Training and Update Course

Recent Changes and
Controversies
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
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 onsite
Discharge - Period of Time
Covered by Standards?
T
BI
conditioning
AT
G HSC
infusion
d7
N
K
0
1
T
CD8+,
B
3
T CD4+
6
9
isolation
MTX/CsA GVH
prevention
0
HS
V
bacteria
month
s
Acute GVH
treatment
2
3
CMCCMV, EBV, adenovirus,
VZV
Candida aspergillus
1
1
2
4
5
month
s
Main
Opportunistic
infections
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
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
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
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’
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
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
Areas of deficiencies
Expressed as % of total deficiencies. Based on
analysis of 1732 deficiencies encountered in
inspections
Research
Disposal
Category
General
Data Management
Process Controls
Therapy Administration
Receipt & Transport
Distribution
Cell Collection
Facilities
Records
Storage
Personnel
Doner Selection, Evaluation & Management
Labels
Policies & Procedures
Quality Management
0%
5%
10%
% of total deficiencies
15%
20%
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
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
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
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
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!!
Inspection report
Corresponds with the exit interview
i.e. no surprises
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
Days to submit Inspection Reports by inspectors
100%
80%
33%
33%
38%
59%
56%
22%
22%
21%
18%
22%
2007
2008
2009
65%
60%
33%
42%
41%
40%
25%
20%
25%
33%
10%
0%
2004
Reporting
2005
2006
Year inspected
? 14 days
15-30 days
>30 days
13b. Median days from audit to receipt of report
160
40
146
120
Days
80
60
25
95
76
60
78
20
87
62
38
20
15
42
44
40
23
30
112
111
100
35
23
23
0
10
5
0
2004
2005
2006
2007
Inspections per year
1. From audit to inspection report
2. With JACIE Office
3. Audit to Summary Report
Inspections
140
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
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!!
Thank You