Quality Control Procedures
During Autotransfusion
AmSECT New Advances in Blood
Management Meeting Seattle,
Washington
September 8, 2011 John Rivera
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Autotransfusion Quality Control Procedures
• AABB 4th Edition of Standards for
Perioperative Autologous Blood Collection
and Administration
• FDA, Joint Commission, CAP, CLIA, OSHA,
State Departments of Health and Ministry of
Health for other countries (all should defer to
the AABB Standards)
• New devices must be validated in-vitro prior
to placing them into use (3.3)
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Autotransfusion Quality Control Procedures
• Standards: 5.1.2 – “A program of quality control shall be
established that is sufficiently comprehensive to insure
that reagents, equipment and methods function as
expected. Results shall be reviewed and corrective
action taken when appropriate.”
• Periodic Quality Control is performed to assess
instrument function and operator competency.
• Exact frequency of testing is not documented, although
most facilities examine individual operators somewhere
between once a month to once a quarter. AABB does
NOT mandate testing of every procedure as well as
every unit of blood collected and processed.
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Medical Director for Autotransfusion Services
• “The perioperative program shall have a
medical director who is a licensed physician
and who is qualified by training and/or
experience. The medical director shall have
responsibility and authority for all policies,
processes and procedures.” Standards: 1.1.1
• “The medical director shall participate in the
development of policies, processes and
procedures regarding the collection and
administration of perioperative products,
including patient selection and preparation of
the patient for surgery.” Standards: 5.2.2
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Autotransfusion Quality Control Procedures
• With the procedure:
– Establish a protocol that includes:
• Suitable cases, surgical applications and
contraindications must be well understood, see
November 2010 Guidelines for Blood Recovery
and Reinfusion in Surgery and Trauma,
Appendix 1
• Applicable patient parameters
• Ideal operating parameters (flow rates, vacuum
levels, wash volumes, etc.)
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Autotransfusion Quality Control Procedures
• With the product:
– Adequate testing of all components (Standards: 5.1.2)
• RBC: hematocrit, residual potassium, residual plasma
protein, volume processed and returned, residual
anticoagulant and free plasma hemoglobin if available
• The goal is to remove 95% of residual potassium or
plasma protein (Collection Reservoir MUST be sampled
before processing and that product MUST be compared
to Holding Bag contents)
• Removal rate for free plasma hemoglobin or residual
anticoagulant should be 90%
• A clear effluent line is not an adequate indicator of
washout
• Periodic quality control testing MUST be performed
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Autotransfusion Quality Control Sampling
• Atraumatic and aseptic, avoid needles and negative
pressure
• Visit with the laboratory to advise them what is
coming
• Transfer samples in containers that do NOT already
contain anticoagulants or preservatives
• Perform testing in a timely manner, especially if using
resdiual potassium as the measure of washout
• Use non-serum based testing devices
• Label samples appropriately
• Post wash samples can be maintained for an
extended time via transfer bag segments
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Autotransfusion Quality Control Procedures
• With the product (Standards: 5.1.2)
– Platelets: count and volume if performing sequestration
and/or platelet gel (Platelet function if that testing is
available), Visual testing, “definition of acceptable results”,
compare pre-counts in blood and citrate syringes versus
post-counts in PRP syringes (not the chart and not patient
whole blood)
– “Bacterial contamination of recovered blood is routine and
little correlation is found with adverse clinical sequelae” (per
November 2010 Guidelines)
– Ideal cellular removal of activated platelets and white cells
should be greater than 90% in washed, recovered
autotransfusion products
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Prevention of Air Embolism (5.4.3)
• Use a Transfer Bag, remove air, tie knots and disconnect and
exchange that bag for a new one
• Or disconnect the Holding Bag after insuring that ALL residual
air has been removed.
• Recovered product must be inspected (by the operator) prior to
release for clots, discoloration, fat, particulate, hemolysis or fluid
interface (Standards: 5.4.2.1)
• “Perioperative products intended for transfusion shall be
transfused through a filter designed to retain particles that are
potentially harmful to the patient.” (Standards: 5.4.5.1) Most
manufacturers recommend the use of a 40 micron
microaggregate filter in addition to the standard blood
administration set
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Conclusion
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There MUST be written and appropriately reviewed policies and
procedures for autotransfusion and the autotransfusion program MUST
have a Medical Director
Regular quality control testing of the recovered washed Packed Red
Blood Cells MUST be performed
The blood in the Collection Reservoir MUST be sampled and tested for
direct comparison to the washed blood in the Holding Bag to confirm
acceptable levels of contaminant removal
Tests completed will depend upon the available technology at each
facility
Quality Control testing MUST be performed in a frequent manner and
frequency of testing should be determined by each individual facility
New autotransfusion devices MUST be validated using the same
Quality Control testing procedures prior to placing them into clinical use
Consider sending out occasional samples for “Gold Standard” testing
for residual free plasma hemoglobin and residual anticoagulant
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