Guidelines for Blood Recovery and Reinfusion

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Guidelines for Blood Recovery and Reinfusion

• Kathleen Grima, MD
• Medical Director, Clinical Services, New York
  Blood Center, White Plains, NY

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Resurging Interest in Perioperative Autologous
Activies

• Avoidance of transfusion-transmitted infection
• Avoidance of transfusion-related immunomodulation
• Concerns regarding the adequacy of the blood
  supply
• Development of new techniques

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Perioperative Autologous Blood Practices - Scope

• Acute normovolemic hemodilution
• Component preparation
• Platelet rich plasma/platelet gel
• Cryoprecipitate/fibrin glue
• Perioperative blood salvage
• Intraoperative or postoperative
• With or without washing

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Importance of Quality

• Goal of perioperative autologous activities is to
  ensure that a safe and quality service is
  provided
• How does one ensure the goal is met?

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Patient Outcome Safety

• A therapeutic product is made
• Processing separation, concentration, washing
• No processing anticoagulation, filtration,
  storage
• Techniques are evolving and information is limited

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Patient Outcome

• Variation in technique or device failure could
  produce an ineffective product
• Platelet gel that does not clot due to a low
  concentration of platelets
• ANH units that are clotted due to inadequate
  anticoagulation
• Salvaged blood units containing large amounts of
  heparin

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Patient Safety

• Incorrect performance of procedure or device
  failure can result in adverse effects to patients

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Autologous Blood - Errors

• 64,500 blood salvage procedures
• 11 errors (1 in 6,000 procedures)
• 2 cases of fatal air embolism
• 2 errors involving transfusion to the wrong
  patient
• 6 cases of hemolysis
• 1 case of unexplained fever
• Linden JV. Transfusion 3428S, 1994.

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What Defines Quality for Perioperative Activities?

• Clinically effective product delivered to the
  right patient in the right way at the right time
  without adverse effect

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What Influences Quality in Perioperative
Activities?

• Infrastructure
• Personnel, equipment, materials, environment
• Process
• Case selection
• Procedural steps
• Storage parameters
• Administration steps
• Adverse effects

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How is Quality Measured?Quality Indicators

• Product quality
• Concentration of component
• Removal of supernatant materials
• Sterility
• Patient outcome measures
• Units of autologous blood transfused per
  procedure
• Appropriate utilization
• Avoidance of allogeneic blood, good outcome

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Quality Indicators, cont.

• Cost-effectiveness
• Event reporting
• Internal assessment
• External assessment
• JCAHO, AABB, FDA, NJDOH

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AABB Standards for Perioperative Autologous Blood
Collection and Administration

• Goal infrastructure to ensure the delivery of a
  consistent high quality product/service to
  patients
• Based on principles of cGMP, TQM
• Contain 10 Quality system essentials
• Contain operational/technical items as well

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QSE1 Organization

• Medical director responsible for all policies,
  processes and procedures
• Role of the blood bank/transfusion service
• Setting expectations regarding service quality
  and outcome with ongoing review and improvement
• Quality system
• Policies, processes and procedures

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Medical Director

• Licensed physician qualified by training and/or
  experience
• Responsible for all policies, processes and
  procedures

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QSE 2 Resources

• Personnel
• Job description/qualification
• Dedicated vs multitasking
• Training
• Periodic competency assessment
• Do they have the time and the skills to perform
  the task effectively?

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QSE 3 Equipment

• Equipment
• Device selection based on intended setting and
  outcome
• Validation
• Ongoing maintenance, calibration, monitoring
• Storage and warming devices

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Platelet Gel Production

• Key questions
• What types of cases will be using this product?
• Oral surgery?
• Plastic surgery?
• Orthopedic surgery?
• What volume of platelet concentration or gel is
  needed?
• Where will the initial blood collection be
  performed?

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Platelet Gel Production

• Whole blood collection high or low volume
• PRP collection blood salvage or apheresis
• Hyperconcentration optional filter device
• Gel formation addition of thrombin and calcium

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Platelet Gel Production

• Goal of Validation demonstrate that a high
  quality product can be made prior to use on
  patients
• Minimum
• Make platelet concentrate using a blood sample
  from a normal individual
• Test to assure that it meets manufacturers
  specifications
• Volume, platelet count
• Gels with addition of thrombin and calcium

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Platelet Gel Production

• Academic validation
• Prepare blood samples with varying hemoglobin
  concentrations
• Prepare platelet concentrate in triplicate
• Measure platelet concentration in initial samples
  PRP
• Measure release of growth factors after gel
  formation

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QSE 4 Supplier Customer Issues

• Identification of critical materials services
• Incoming receipt, inspection testing of
  critical materials
• Expectations for support and service from
  manufacturer or service provider
• Supplier qualification
• Agreements

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QSE 5 Process Control

• SOP with change control
• Conformance with manufacturers directions for
  use
• Standardized procedural records
• Defined clinical applications including
  contraindications and process for dealing with
  exceptions

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QSE 5 Process Control

• Defined operational parameters
• Vacuum regulation
• Anticoagulant solution
• Circuit configuration
• Filtration
• Wash volumes
• Standardized labeling procedures

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Blood Salvage with Processing Case Selection

• Indications contraindications
• Policies on cancer, contaminated wounds,
  obstetrics, collagen preparations, Witness
  patients.
• Process for exceptions
• Ordering process

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Blood Salvage with Processing Procedural Steps

• Patient identification
• Vacuum control
• Suction apparatus/technique
• Anticoagulation agent ratio
• Policy regarding contamination, dilution with
  irrigation fluid, aspiration of medications not
  intended for IV administration

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Blood Salvage with Processing Procedural Steps

• Pump speeds
• Fill, wash, empty
• Wash parameters
• Solution, volume, waste line monitoring
• Technique to avoid air embolism
• Labeling

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Blood Salvage with Processing Procedural Steps

• Policies on fat contamination, partial bowls,
  salvage from sponges
• Special techniques
• Filtration (leukocyte reduction, fat reduction,
  microaggregates)
• irradiation

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QSE 5 Process Control

• Define handling, storage and expiration
  parameters
• Standardized administration protocols including
  use of ancillary devices
• Periodic quality testing of products
• Tests to be performed
• Thresholds for acceptability
• Frequency of testing

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Process Control Storage Handling
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Blood Salvage with Processing Quality Assurance

• Final product testing
• Visual inspection
• Weight or volume
• Hematocrit
• Supernatant removal (color of waste line
  residual heparin concentration albumin,
  potassium, or free hemoglobin removal)
• Sterility

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QSE 6 Documents Records

• Document control
• Master list
• Standard format
• Review approval process
• Records
• Computer systems

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QSE 7 Nonconformances

• Process to capture, assess, investigate, monitor
  deviations and nonconforming products/services
• Control of nonconforming products or services
• Process for review disposition of nonconforming
  products services
• Process for detection, reporting, evaluation of
  adverse events

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QSE 8 Internal External Assessments

• External assessments (inspections, surveys)
• Internal assessments (audits)
• Management follow up of results
• Utilization review

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Utilization Review

• Data reviewed as requested
• Utilization by surgical service
• Data reviewed monthly
• Cases with not enough blood to process (7)
• Mean yield per procedure by surgical type (2.6
  units)
• Discard rate (1.3)
• Proportion of all RBC units collected (15)

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QSE 9 Process Improvement

• Mechanism to identify improvement opportunities
• Process for analysis and implementation
• Corrective action
• Preventive action

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Process Improvement

• Entry of results for incorrect patient
• Root cause manual entry of 7 digit clinic
  number multiple times during process
• Corrective action
• Secondary review of all records by management
  staff with correction of all errors
• Preventive action
• Implementation of barcode labels for clinic
  number
• Future implementation of system to directly
  download results into computer

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QSE 10 Facilities Safety

• Safe enviroment
• Biological, chemical radiation safety
• Discard of products

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AABB Standards for Perioperative Autologous
Blood Collection Adminstration

• AABB Guidance for Standards and AABB Guidelines
  for Blood Recovery and Reinfusion in Surgery and
  Trauma

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Conclusions

• The standards for perioperative autologous blood
  collection and administration provide the
  infrastructure to ensure the delivery of a
  consistent high quality product to our patients