Inspection of Collection
Facilities
Collection Standards: C1 General
• Apply to all CTPs collected from living
donors
• Facility must apply with all applicable
laws e.g. HTA
• Facility, CFD, CFMD and one staff
member in place at least 1 year
• Minimum 10 PBSC or 1 BM collection
in preceding year (re-accreditation 40
PBSC / 4 BM in 4 year cycle)
C2: Collection Facility
• Appropriate, designated areas for collection, storage of
product, supplies and equipment
• Suitable and confidential space for donor examination
and evaluation
• Process to control storage areas to prevent mix-up,
contamination and cross contamination during
quarantine, prior to release and for non-conforming
products
• Transfusion Service - irradiated and CMV appropriate
blood products
C3: Collection Facility
Director
• Medical or relevant** degree + training / exp
• May also be the MD if appropriate
• 1 year’s CTP collection experience
• Performed or supervised min 10 CTP apheresis collections
in last 3 years
• Figure for marrow is 10 in their career
C3 Collection Facility
Medical Director
• Licensed physician + appropriate
postgraduate training (may also be CFD)
• Responsible for care of patients and
donors and evaluation, management of
complications
• 1 year in cell therapy product collections
• Numbers of collections as for the CFD
Paediatric Donors/Patients
• For CF performing paediatric apheresis there shall be
documented training and experience in these procedures
(C3.3.2)
• Collection methods for paediatric donors shall employ
appropriate adjustments to the procedure (C8.13)
C4 Quality Management
Plan (QMP)
• This a key document and often deficient
• CFD responsible for QMP
• Organisational chart of key personnel and
functions – how do they interact to
implement the QMP
• Personnel requirements including
qualifications, training, competency
• Document control – development,
approval, review etc for SOPs,
worksheets, forms and labels
C4 Quality Management
Plan (QMP)
• Written agreements with 3rd parties –
responsibility of facility to establish and
maintain; ensure external entities comply
with laws/regulations
• Documentation and review of products and
outcomes e.g. engraftment
• Conduct of audits
• Management of CTPs with positive microbial
cultures
C4 Quality Management
Plan (QMP)
• System for - errors, accidents,
adverse events and complaints
• Process for product tracking
• Process for continuous operation
of electronic records
• Qualification of equipment,
supplies and reagents
• Validation of processes
C5 Policies and Procedures
• List of what must be addressed eg
donor consent, product collection,
labelling
• 17 are listed but this doesn’t mean
there have to be 17 SOPs
• There must be
- SOP for SOPs
- Standardised format
- System of numbering, titling
• Each individual procedure shall include
– purpose, equipment, description of
procedure and references
C6 Donor Evaluation and
Management
• Consent – clear, able to ask
questions etc
• Suitability – includes ABO and
pregnancy testing, risks of CVCs,
anaesthesia and G-CSF
• Use of non-conforming donors,
communication to physicians
• Evaluation and testing for IDMs
C7 Labelling
• Labels - held upon receipt/printed on
demand reviewed against a copy or
template
• Obsolete labels destroyed
• Archive representative labels for 10 years
• Biohazard labels - risk factors or marker
positive
• Label Table: will defined whether
information should be affixed (AF),
attached (AT) or in accompanying
documents (AC)
• Labelling of concurrent plasma and
samples
C7 Biohazard labels
• Biohazard label if screening indicates
presence of a communicable disease,
risk factor or clinical signs of one
• Creates 3 categories of product
labelling:
- warning tests reactive for…
- warning advise patient of
communicable disease risk
- not evaluated for infectious
disease risk
Table 1
Label content adapted from FACT-JACIE
Element
Unique identifier of product
Proper name of product
Recipient name and identifier
Labelling
Table
Date, time collection ends and (if
applicable) time zone
Approximate volume
Name and volume or conc. of
anticoagulant and other additives
Partial label
Label at
completion of
collection
Label during
processing
Label at
completion of
processing
Label at
distibution
AF
AF
AF
AF
AF
AF
AF
(if
applicable)
AF
AF
AF
AF
AF
(if applicable)
AF
(if applicable)
AF
(if applicable)
AF
AF
AC
AC
AF
AC
AC
AC
AC
AC
AF
AT
AT
AC
AC
AC
AT
AT
AT
AC
(if applicable)
AC
(if applicable)
AC
(if applicable)
Identity and address of processing facility
AF
AF
ABO and Rh of donor
AC
RBC compatibility testing results
AC
AC
AC
(if applicable)
Statement “Properly identify intended
recipient and product”
AC
AC
Statement “Warning; this product may
transmit infectious agents”
AF
AF
AF
(if applicable)
AF
(if applicable)
AF (if
applicable)
AF
(if applicable)
AF
(if applicable)
AF
(if applicable)
AF (if for
allogeneic
recipient)
AF (if for
allogeneic
recipient)
AT
AT
(if applicable)
AT
AT
(if applicable)
Donor identifier and (if applicable) name
Identity and address of collection facility or
donor registry
Recommended storage temperature
Biohazard label
Expiration date
Expiration time
Statement “For autologous use only”
Innerand outer
shipping container
AC
(if applicable)
or
Statement “For use by intended recpient
only”
Statement “Do not irradiate”
Statement ” Not for infusion’”including
reason
Name and address of receiving institution
Name and phone number of contact
person at receiving institution
Statement“Medical Specimen”
AF
AF
AF
Statement “ Do not X-Ray”
Af
Name,address and phone number of
shipping facility
AF
C8 Process Controls
• Done according to written procedures
• Written order from a physician
• Document interim assessment of donor
suitability immediately before
• Blood count within 24 hours - criteria
• Suitably qualified anaesthetist
• Central lines - licensed, qualified
physician
• G-CSF - experienced physician
• Procedures have acceptable
viability/recovery
C 9, 10 Storage, transportation
and shipping
• Policies for storage prior to
transportation to a processing lab –
control storage areas
• Procedures must protect: product
and staff
• Sealed in secondary container
• Shipped to PL at defined temperature
• Outer container if sent to noncontiguous facility
• Required accompanying records
C11 Records
• Facility records relating to QC etc 10 years
• Patient records - min 10 years after
infusion and as according to
‘governmental laws’
• Research records - min 10 years
after infusion
• Where divided must show extent of
each facility’s responsibility
• Electronic records
• Expanded requirements for donor
records
C12: Direct Distribution to
Clinical Programme
• Where cells are directly distributed
to clinical facility without going
through a processing facility, then
requirements for labelling,
documentation, distribution,
transportation and record keeping
in Section D7,8,10 and 12 apply
Collection Facilities – Most
Common Deficiencies
•
•
•
•
Policies and procedures
Engraftment data
QMP
Review of new/revised
policies
Occasional Use of BM
• The clinical facility must use a collection facility that confirms to the
standards
– The Clinical Program shall have access to licensed physicians who
are trained and competent in bone marrow harvesting and a bone
marrow collection facility that meets these Standards.
• For accreditation of Bone Marrow Collection, BM Collection Facility
must perform at least 1 BM harvest in the year prior to initial
accreditation and 4 harvests in each 4 year accreditation cycle
thereafter.
• What happens if the centre collects BM but not often enough to apply
for accreditation for BM collection?
Bone Marrow Collection
• May be forgotten if very few
harvests
• Minimum is 1 in 12 months
before initial accreditation and
4 per 4-yr re-accreditation
cycle
• SOPs
• Staff competency and
experience
• Centre can opt to collect
elsewhere
C2 Collection Facilities - Problems
• Staff not aware of emergency facilities
• No suitable space for donor examination
• Lack of proper disposal of apheresis kits (biohazard)
• Prophylactic platelets given to healthy donors
• No evidence of training and compliance with Biological
Safety Regulations
C3 Personnel
•
Inadequate documentation of
training, proficiency and continued
competency
• MD not responsible for donor
evaluation and safety
• MD does not have appropriate
contract with facility
• No record of how many
procedures are done
C4 QM - BM Harvest
•
•
•
No procedure / documentation
relating to validation of equipment
/ procedures
Expiration dates and lot numbers
of the reagents / equipment used
for BM harvest not recorded
Records of collection not regularly
reviewed by CF Director - evidence
of appropriate meetings
•
•
Lack of quality audit procedure AE, yields
Reporting AE’s to clinical unit SOP
C4.000 QM- Peripheral Blood
• Collection outcomes e.g. yields
and AE’s not regularly reviewed
by CF Director
• The QMP should describe the
validation of significant apheresis
procedures
• The QMP should give the range
of expected outcomes/results
C5 Collection SOPs
•
No SOP for donor screening, consent,
training, BM collection, storage or transport
•
SOPs present but inadequate e.g. no
acceptable results and tolerance limits, no
instruction for action if these are not met
•
Range of expected results, ranges and end
points not defined in SOP for stem cell
collection
•
No examples or worksheets and labels
•
No arrangements for biannual review
•
No procedure for recording deviation from
the SOPs relating to stem cell collection, or
whether and how such deviations are
approved
SOP Illustration:BM Harvest
Code:
SOP/BRI/SB/004/02
Replaces:
SOP/BRI/SB/004/01
Copy No:
Issuing Dept:
STEM CELL
Summary of Significant Changes (Changes are indicated by a vertical line in the right hand
margin):
SAFETY PRECAUTIONS AND HAZARDS
See relevant Health & Safety procedures.
All blood and derivatives must be treated as potentially infective.
NBS staff attending marrow harvests are not trained or authorised to move patients
under general anaesthetic in the operating theatre.
Use a trolley for transporting the harvest box to reduce manual handling injury.
New data sheet DAT/BRI/SB/047 Bone marrow harvest volumes
INSTRUCTIONS
At NBS - Bristol Centre
Purpose and Scope
Items Required
One of the many factors that are linked to a
successful graft after bone marrow transplantation is
the number of nucleated cells harvested per kilogram
body weight of the recipient. It is widely reported that
8
for allogeneic transplant a dose of 3 x 10 /kg body
weight is required.
1. Anticoagulant collection medium – see
SOP/BRI/SB/051 – Preparation of Bone Marrow
Collection Medium
2. Heparin (1000in/ml in 5ml ampoules)
3. Scales
4. DAT/BRI/SB/004 – Equipment Required for Bone
Marrow Harvesting
5. DAT/BRI/SB/005 – Equipment Diagrams for Bone
Marrow Harvesting
6. DAT/BRI/SB/006 – Bone Marrow Harvest Volume
Charts
7. FRM/BRI/SB/010 - Haemopoietic Progenitor Cells
Labels
8. FRM/BRI/SB/011 – Bone Marrow Harvest Form
9. SOP/BRI/SB/008- Information And Handling
Instructions For Cryopreserved Allogeneic
Haemopoietic Progenitor Cells
10. DAT/BRI/SB/047 - Bone marrow Harvest volumes
Haplotype mismatched transplants require higher
target cell doses to overcome graft rejection, these
are usually not available from a single bone marrow
collection so the harvest team will collect the
maximum volume available without risking donor
wellbeing.
Definitions
Grade/Qualifications Needed and
Responsibilities
EDTA EthyleneDiamineTetraAcetic Acid +
Anticoagulant works by chelation of Ca ions
Acid Citrate Dextrose Anticoagulant
ACD
BMS Biomedical Scientist
Trainee/BMS trained in laboratory and operating
theatre aseptic technique and known to the collection
team at the harvesting hospital. Responsible for
obtaining written confirmation of current virology
status of the patient before the harvest and, after
agreement with the harvest clinicians, monitoring the
volumes and doses being harvested, and setting the
end point of the collection when there are no
immediate clinical considerations about patient
safety.
Author
A N Other
Effective Date
DRAFT
1.
Assemble equipment required at the harvest - see DAT/BRI/SB/004 for variants.
2.
Take the bone marrow harvest volume data sheet if required (DAT/BRI/SB/047)
3.
From the details supplied on the patient referral form (national form 2E), prepare
sufficient labels (FRM/BRI/SB/010).
4.
Go to harvesting hospital in good time.
At Harvesting Hospital
5.
If written confirmation of the patients current virology status has not been
received in advance of the collection, request that the consent form (national
form 2B) is completed and that samples are taken for mandatory testing before
the collection begins.
6.
Follow local theatre rules on theatre dress, scrubbing and gowning.
7.
Confirm the correct identification of the patient with the anaesthetist or
harvesting physician who should sign the Bone Marrow Harvest form
(FRM/BRI/SB/011) accordingly.
In Theatre
8.
Arrange required equipment for placing on a sterile field.
9.
Provide scrub nurse with heparin to prepare syringe rinse bowls containing 20
units/ml in 0.9% saline.
10.
Arrange a non-sterile trolley for the scales, if needed. A sterile tray will be
provided for the scales.
Once scrubbed and gowned assemble collection pack, anticoagulant (See
SOP/BRI/SB/051) , taps and sampling site couplers as shown in relevant equipment
diagrams in DAT/BRI/SB/005.
C6 Donor Selection &
Management
• No written orders for collection
• Absence of written consent
• No arrangements for assessment of
(interim) donor suitability
• No formal policy / SOP for
assessment of venous line placement
• Assessment of venous line
placement not documented in
patient/donor record
• IDM testing
C6 Donor Selection &
Management
• No evidence that donor
informed of abnormalities and
arrangements for follow-up
• No secondary bag for
transportation
• No SOP for transport to
processing lab
D7 - LABELS
• Responsibility for label
production and control unclear
- new SOP
• Lack of unique alphanumeric
identifier
• Must give proper name e.g.
Human HPC-Apheresis
• CF and PL need to agree HPC
identifiers
Autologous Collection Label
•
•
•
•
•
•
•
Unique alphanumeric number
Product name
Date and time
Name and volume of AC and other additives
Name of collection facility
Recommended storage temperature
Biohazard label if required
C9.000 Records
• Facilities for patient record
storage inadequate
• No records for ... personnel
training
• No copy of collection record
(safety, purity)
sent to Clinical Unit
Transportation
• No SOP covering transportation from the
apheresis unit to the processing facility
• Lack of stated temperature for transport
• Lack of secondary container