Quality System for Blood
Establishments
Morris R. Dixon MM,MT(ASCP)SSB
Director of Operations
Blood Systems Laboratories
Dallas, Texas, USA
Blood Systems Laboratories
Blood Systems Laboratories
BSL Customers
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Two Laboratories
Dallas, TX
Phoenix, AZ
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Testing 3 million samples per year
Inspected by:
US FDA
AABB
EMEA (EU)
Austria
Ireland
Germany
UK (Directive 2005/62/EC
Regulations
Commission Directive 2005/62/EC
Quality Policies
Standard Operating Procedures
Documentation
Evidence of Compliance
A quality system for blood establishments
should embrace the principles of quality
management, quality assurance,
continuous quality improvement, and
should include:
Personnel
Premises and Equipment
Documentation
Collection
Testing and Processing
Storage and Distribution
Contract Management
Non-Conformance and Self-Inspection
Quality Control
Blood Component Recall
External and Internal Auditing
Blood and blood components imported
from third countries….. should meet
equivalent Community standards and
specifications relating to a quality system
for blood establishments as set out in this
Directive.
Directive 2005/62/EC
Annex
Quality System Standards
and Specifications
1.1.1 Quality System
Quality shall be recognised as being the
responsibility of all persons involved in the
processes of the blood establishment with
management ensuring a systematic approach towards quality and the Implementation and maintenance of a quality
system.
The achievement of
Quality System Standards is
everyone’s job
Director→Staff
1.1.3 Quality System
The quality system shall ensure that all critical
processes are specified in appropriate instructions and are carried out in accordance with the
standards and specifications set out in this
Annex.
Management shall review the system
at regular intervals to verify its effectiveness
and introduce corrective measures if deemed
necessary.
Why Standard Operating
Procedures?
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Define policies.
Describe procedures.
Control processes.
Meet regulatory requirements.
USFDA CFR Part 211.100(a)
There shall be written procedures for production and process controls to assure
that products have the strength, purity
identity and quality they are represented
to possess.
USFDA CFR Part 606.100 (b)
Written SOPs shall be maintained for all
steps to be followed in the collection, processing, testing, storage and distribution of
blood and blood components.
Procedures shall be available for use in
the areas where the procedures are
performed.
1.2.1 Quality Assurance
All blood establishments and hospital
blood banks shall be supported by a
quality assurance function, whether
internal or related, in fulfilling quality
assurance. That function shall be involved in all quality-related matters and
review and approve all appropriate quality
related documents.
USFDA CFR Part 211.22 (a)
There shall be a quality control unit that
shall have the responsibility and authority
to approve or reject all components…and
the authority to review production records
to assure that no errors have occurred or,
if errors have occurred, that they have
been fully investigated.
USFDA CFR Part 211.22 (c)
The quality control unit shall have the
responsibility for approving or rejecting all
procedures or specifications impacting on
the identity, strength, quality, and purity of
the drug product.
1.2.2 Quality Assurance
All procedures, premises, and equipment
that have an influence on the quality and
safety of blood and blood components
shall be validated prior to introduction and
be re-validated at regular intervals determined as a result of these activities.
2.1 Personnel and Organisation
Personnel in blood establishments shall be
available in sufficient numbers to carry out
the activities related to the collection,
testing, processing, storage and distribution of blood and blood components and
be trained and assessed to be competent
to perform their tasks.
3.1 Premises (General)
Premises including mobile sites shall be
adapted and maintained to suit the
activities to be carried out. They shall
enable the work to proceed in a logical
sequence so as to minimise the risk of
errors, and shall allow for effective
cleaning and maintenance in order to
minimise the risk of contamination.
4.1 Equipment and Materials
All equipment shall be validated, calibrated
and maintained to suit its intended
purpose. Operating instructions shall be
available and appropriate records kept.
4.3 Equipment and Materials
Only reagents and materials from
approved suppliers that meet the documented requirements and specifications
shall be used. Critical materials shall be
released by a person qualified to perform
this task.
5.1 Documentation
Documents setting out specifications,
procedures and records covering each
activity performed by the blood establishment shall be in place and kept up to
date.
5.3 Documentation
All significant changes to documents shall
be acted upon promptly and shall be
reviewed, dated and signed by a person
authorised to perform this task.
Effective Documentation
Trackability – The steps of the process.
Traceability – What happened at each
step.
Concurrent Documentation
Is documentation of an action prior to
performing another action.
USFDA CFR 606.160 (a)(1)
Records
Records shall be maintained concurrently
with the performance of each significant
step in the collection, processing, compatibility testing, storage and distribution of
each unit of blood and blood components
so that all steps can be clearly traced.
All records shall be legible and indelible,
and shall identify the person performing
the work.
6.1.2 Donor Eligibility
The donor interview shall be conducted in
such a way as to ensure confidentiality.
6.2.1 Collection of Blood and Blood
Components
The blood collection procedure shall be
designed to ensure that the identity of the
donor is verified and securely recorded
and that the link between the donor and
the blood, blood components and blood
samples is clearly established.
6.3.1 Laboratory Testing
All laboratory testing procedures shall be
validated before use.
6.3.3 Laboratory Testing
There shall be clearly defined procedures to
resolve discrepant results and ensure that blood
and blood components that have a repeatedly
reactive result in a serological screening test for
infection with the viruses mentioned in Annex IV
to Directive 2002/98/EC shall be excluded from
therapeutic use and be stored separately in a
dedicated environment.
6.3.3 Laboratory Testing
(Continued)
Appropriate confirmatory testing shall take
place. In case of confirmed positive
results, appropriate donor management
shall take place including the provision of
information to the donor and follow-up
procedures.
6.3.4 Laboratory Testing
There shall be data confirming the suitability of any laboratory reagents used in
the testing of donor samples and blood
component samples.
6.3.5 Laboratory Testing
The quality of the laboratory testing shall
be regularly assessed by the participation
on a formal system of proficiency testing,
such as an external quality assurance
programme.
6.6.1 Release of Blood and Blood
Components
There shall be a safe and secure system
to prevent each single blood and blood
component from being released until all
mandatory requirements set out in this
directive have been fulfilled.
Each blood establishment shall be able
to demonstrate that each blood or blood
component has been formally released
by an authorised person.
6.6.1 Release of Blood and Blood
Components (Continued)
Records shall demonstrate that before a
blood component is released, all current
declaration forms, relevant medical records and test results meet all acceptance
criteria.
7.2 Storage and Distribution
Procedures for storage and distribution shall be
validated to ensure blood and blood component
quality during the entire storage period and to
exclude mix-ups of blood components.
All transportation and storage actions, including
receipt and distribution, shall be defined by
written procedures and specifications.
9.2 Complaints
All complaints and other information,
including serious adverse reactions and
serious adverse events, which may suggest that defective blood components
have been issued, shall be documented,
carefully investigated for causative factors
of the defect and, where necessary, followed by recall and the implementation of
corrective actions to prevent recurrence.
9.2 Complaints (Continued)
Procedures shall be in place to ensure that
the competent authorities are notified as
appropriate of serious adverse reactions
or serious adverse events in accordance
with regulatory requirements.
9.4.1 Corrective and Preventive
Actions
A system to ensure corrective and
preventive actions on blood component
non-conformity and quality problems shall
be in place.
9.4.2 Corrective and Preventive
Actions
Data shall be routinely analysed to identify
quality problems that may require corrective action or to identify unfavorable
trends that may require preventive action.
9.4.3 Corrective and Preventive
Action
All errors and accidents shall be documented and investigated in order to
identify system problems for correction.
Deviation Management
Is the tracking of a deviation from
established SOPs.
Deviation Management System
• Detect deviations.
• Report deviations.
• Analyze deviations.
• Correct deviations.
• Prevent deviations.
USFDA CFRs
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211.180(e) and (f), General Requirements
211.192, Production Record Review
211.198, Complaint Files
600.12, Records
606.170, Adverse Reaction File
10.1 Self-Inspection, Audits and
Improvements
Self-inspection or audit systems shall be in
place for all parts of the operations to
verify compliance with the standards set
out in this Annex. They shall be carried
out regularly by trained and competent
persons in an independent way according
to approved procedures.
10.2 Self-inspection, Audits and
Improvements
All results shall be documented and
appropriate corrective and preventive
actions shall be taken in a timely and
effective manner.
Red Cell Serology - Bedford 2009 Deviations
YTD:
2008:
CR’s = 13
CR’s =29
NR’s = 6
NR’s = 9
Avg=3.3
Avg=2.4
CR
CC
NR
Avg= 1.5
Avg= 0.8
RRC
2
1
1
1
2
3
17
14
19
15
1
1
3
2
3
1
3
Apr May Jun
2
1
Jul
2
3
Aug Sep
1
1
1
3
Oct Nov Dec
6
5
1
1
Jan
Feb Mar Apr
60
Viral Marker Testing - Bedford 2009 Deviations
YTD: CR’s = 7
2008: CR’s =53
NR’s = 2
NR’s = 10
Avg= 1.75
Avg= 4.4
CR
CC
NR
RRC
1
6
1
6
4
Avg= 0.5
Avg= 0.8
1
1
8
8
1
1
1
5
1
3
Apr May Jun
1
1
1
1
Jul
3
3
1
2
Aug Sep Oct Nov Dec
2
Jan
3
Feb Mar Apr
61
Bedford Total Deviations Normalized
Per 100,000 Samples
1.00
0.80
0.60
0.40
0.20
0.00
J an
F eb Ma r Apr Ma y J un
J ul
Aug S ep
Oc t Nov Dec
2007 0.40 0.59 0.58 0.47 0.71 0.48 0.78 0.89 0.80 0.80 0.61 0.49
2008 0.48 0.32 0.23 0.28 0.30 0.24 0.26 0.20 0.21 0.32 0.14 0.33
2009 0.19 0.19 0.16
62
Process Failure/SOP Deviation
Normalized Per 100,000 Samples
Tempe
Process Failure/SOP Deviation
Normalized/100,000
Bedford
Ap
r-0
9
Fe
b09
M
ar
-0
9
Ja
n09
No
v08
De
c08
ct08
O
Se
p08
Ju
l-0
8
Au
g08
Ju
n08
08
M
ay
-
Ap
r-0
8
14.0
12.0
10.0
8.0
6.0
4.0
2.0
0.0
63
Questions?