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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

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collection standards c1 general
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
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
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
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
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
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 qmp8
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 qmp9
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
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
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
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
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

c8 process controls
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
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 non-contiguous facility
  • Required accompanying records
c11 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
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
Collection Facilities – Most Common Deficiencies
  • Policies and procedures
  • Engraftment data
  • QMP
  • Review of new/revised policies
occasional use of bm
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


Staff competency and experience

Centre can opt to collect elsewhere

Bone Marrow Collection
c2 collection facilities problems
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
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
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
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
c6 donor selection management
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 management29
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


  • 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
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
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
  • No SOP covering transportation from the apheresis unit to the processing facility
  • Lack of stated temperature for transport
  • Lack of secondary container