Key Considerations During Autotransfusion Region 7 ASATT Meeting Bellevue, Washington John Rivera, BS, MA

AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma Issued in 2010 These Guidelines are a key document along with the 5th Edition of AABB Standards for Perioperative Autologous Blood Collection and Administration, January 1, 2013 There are significantant updates in a variety of autotransfusion practices

Blood Recovery Recovery of shed blood, its processing and re-administration Washed and filtered or simply filtered Primarily washed intraoperatively and filtered postoperatively Centerpiece of a blood management program in combination with other techniques and modalities AABB Guidelines 2010, pg. 1

Why Blood Recovery? Returns patient’s own blood avoiding or reducing complications such as transmission of infectious agents Minimizes immunosuppressive effects of allogeneic blood Immediate availability of blood for patients with compatibility issues Serves as an acceptable alternative for patients with religious objections to allogeneic transfusion AABB Guidelines 2010, pg. 1

Why Autotransfusion? Immediate availability Conserves allogeneic blood for real emergencies Eliminates clerical errors Is truly cost effective

What are the Real Costs of Transfusion? Activity-based costs of blood transfusion in surgical patients at four hospitals, Shander, A. et al, Transfusion 2010;50:753-756 Englewood Medical Center, Englewood, NJ, Rhode Island Hospital, Providence, RI, University Hospital, Lausanne, Switzerland and General Hospital, Linz, Austria (both have similar costing models to LA) COBCON (Costs of Blood Consensus) and ABC (Activity Based-Costing) Direct and indirect overhead costs, not just acquisition costs $552-$1183 with a mean of $761 +or- $294 3.2 to 4.8 fold higher than initial product costs “Blood costs have been underestimated” A more recent study of American and European Hospitals. Even “free” blood costs a lot of money to inventory, monitor and issue for transfusion.

Autotransfusion Triggers Anticipated blood loss is equal to or greater than 1000 ml Procedures where 2 units of blood are routinely cross matched Procedures where 20% of the patients are routinely transfused Emergency procedures Patients with rare blood types or incompatibilities Patients with religious objections to allogeneic blood components

“Indications for Use” Start with a “stand-by” setup to include a collection reservoir, reservoir connector, suction/anticoagulant line and anticoagulant Cost of the “stand-by” setup can be less expensive than cross-matching two (2) units of allogeneic blood If major blood loss is certain, collection and processing of recovered blood can occur Applicable in open-heart, vascular, total joint, spinal, liver transplant, ruptured ectopic pregnancy and trauma surgeries AABB Guidelines 2010, pg. 2

Standby Collection System

Autotransfusion System Components Suction tip Suction/anticoagulant line Anticoagulant solution Filtered Collection Reservoir and connector Centrifuge bowl and disposable tubing set (tubing, bowl, holding bag and waste bag) Normal saline (0.9%) wash solution bags Blood Transfer Bags

“Maximizing Effectiveness” Appropriate suction levels, 80 to 120 torr, which can be temporarily increased “in the event of massive blood loss” Suction tip style and technique, appropriate size and immersion in pools of blood to minimize air aspiration Timely sponge rinsing with appropriate isotonic solutions Use of either heparin or citrate anticoagulants or a combination of both AABB Guidelines 2010, pp. 2-4

FDA Website April 7, 2010 Data from post market studies reinforce FDA's previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient and consider the clinical circumstances where the potency decrease may require dosage adjustments and more frequent monitoring. Heparin products made using both the old and the new USP standards may be available for some time (last production lots of old potency expire fall of 2011) do not use the products interchangeably. separate the supplies of old and new heparin and exhausting the supplies of "old" heparin before transitioning to the "new" product FDA recommends that healthcare professionals: Be aware that there is an approximate 10% decrease in the anticoagulant activity (potency) of the "new heparin" compared with the "old heparin" Continue to exercise clinical judgment in determining the dose of heparin. Continue to individualize heparin dosing to the specific patient/patient-specific clinical situation Understand that the labeling for heparin, including the recommended doses for heparin has not changed Consider those clinical circumstances where the potency decrease may require dosage adjustments and more frequent monitoring, such as where aggressive anticoagulation is essential to the treatment of the patient, including but not limited to: pediatric patients undergoing extracorporeal membrane oxygenation adults and children undergoing cardiopulmonary bypass the treatment or prevention of life-threatening thromboses

Anticoagulation Heparinized saline - 30,000 units of heparin per 1000 ml 0.9% Normal saline or 15,000 units of heparin per 500 ml Normal saline Heparin complexes with Antithrombin III (ATIII) Heparin should not be used on ATIII deficient patients or patients prone to Heparin Induced Thrombocytopenia (HIT) ACD-A inhibits the early steps in the clotting cascade by chelating (binding) Calcium Do not use ACD-A on patients with impaired liver function ACD-A is already pre-mixed in plastic bags Do not aspirate blood mixed with Ringers Lactate irrigation solutions when using citrate based anticoagulants

Anticoagulation Re-prime the reservoir with at least 100 ml of anticoagulant every time the reservoir is emptied Agitate the reservoir occasionally Change inlet ports on the reservoir if needed due to clotting Change suction/anticoagulant lines if needed due to clotting Change reservoirs if clotting is observed on the outside of the filter

Contraindications Absolute – inadvertent blood exposure to “solutions that cause hemolysis”: sterile water, hydrogen peroxide, alcohol, hypotonic solutions or other solutions that are “incompatible with red cells” Relative – “blood aspirated from contaminated or septic wounds or obstetric/surgical fields, and areas of malignancy” Use of a double setup of two (2) collection reservoirs and suction/anticoagulant lines minimizing contamination of the recovered blood Filtration of the recovered, washed blood with leukocyte filtration AABB Guidelines 2010, pp. 6-7

Contraindications The final decision on whether to salvage and process the blood is the autotransfusion team’s decision, e.g., (Blood Bank, Surgeon, Anesthesiologist and Autotransfusionist) See the November 2010 AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma, Appendix 1: Complications of and Contraindications to Perioperative Blood Recovery Understand that some contraindications are not absolute or may be temporary in nature Read the product inserts regarding the approved use of that agent or device during autotransfusion AABB Guidelines 2010, pp. 6-7

Special Considerations Religious objections to allogeneic transfusion Rare blood types with limited supply in the Blood Bank Previously transfused patients who are sensitive to transfusion and/or difficult to find compatible blood Low blood supply in the Blood Bank at that moment

Tandem Collection Reservoirs 2 collection reservoirs, 2 suction/anticoagulant lines and 2 bags of anticoagulant solution Individual vacuum sources for each collection reservoir if at all possible Side by side or “Piggyback” collection reservoir configurations Use a waste suction line as well Multiple autotransfusion devices can be used concurrently

Tandem Collection Reservoirs

“Complications of Intraoperative Blood Recovery” Air embolism - use a “secondary reinfusion bag” (Transfer Bag), remove air and disconnect and replace with another bag Air embolism is a potential cause of injury and death during autotransfusion procedures “Under no circumstances should a pressure cuff be used on the primary reinfusion bag when blood is being directly reinfused into the patient” Avoid inadvertent mixing of the recovered blood with inappropriate solutions The final product is washed red blood cells in a small amount of 0.9% saline solution AABB Guidelines 2010, pp. 7-8

In Trauma Situations It is critically important to set up the suction/anticoagulant line, anticoagulant solution and collection reservoir ASAP Employ liberal dosing of anticoagulant solutions Utilize dedicated vacuum sources for each collection reservoir and suction/anticoagulant line Consider the use of tandem Collection Reservoirs and more than one autotransfusion device Use the “Trauma” program on the device

Autotransfusion Post-Operative Blood Processing Once the patient arrives in the Recovery Room, connect the reservoir vacuum line to an Intermittent Vacuum Regulator, if available Vacuum pressure should be set at a maximum of 80 mm/Hg If an Intermittent Vacuum Regulator is NOT available, it is advisable to periodically vent the Collection Reservoir Mark the fluid level on the Collection Reservoir if not previously completed and note the patient arrival time in the Recovery Room Blood must be processed and transfused within six (6) hours from the start of collection into the reservoir If the reservoir is completely emptied during processing, another six (6) hour time period can be initiated. Maximum time that the disposable can be used is 24 hours. Monitor fluid levels in the anticoagulant bag and Collection Reservoir on a hourly basis Terminate post-operative blood collection if drainage volumes fall under 100 ml per hour or if six (6) hours has transpired without blood processing

“Unwashed Systems for Postoperative Recovery” Specifically designed for postoperative use Blood is collected and filtered and anticoagulant is not always used “When adequate amounts of blood are collected, the device is typically flipped over and the blood runs through a filter” and these are frequently called “flip-n-drip” systems Use suction levels below 100 mmHg and citrate anticoagulant is preferred AABB Guidelines 2010, pp. 8-10

Potential Complications of the Reinfusion of Unwashed, Shed Blood Contaminants such as “tissue fragments; activated clotting factors; complement proteins; lymphokines; and exogenous materials, such as antibiotics and topical clotting agents” Recommendations to limit the amount of unwashed blood being reinfused Febrile reactions – “4% to 12%” and potential for hypotension Washing the this blood is a simple solution, but that involves the availability of trained operators and devices AABB Guidelines 2010, pg. 9

“Partially Filled Bowls” “Low hematocrit (usually <15%) in the final product” Cellular debris in “higher concentrations than…following a normal wash” “Transfusion of a clinically insignificant red cell mass” versus complications, there is limited evidence supporting this practice Alternatives include Return or Concentrate functions AABB Guidelines 2010, pp. 5-6

Expiration Times Hemodilution - 8 hours at room temperature Intraoperative autotransfusion with blood processing at room temperature – 4 hours from completion of processing Intraoperative autotransfusion with processing, 1 – 6 degrees C, 24 hours total if refrigerated within 4 hours of processing Intraoperative autotransfusion without processing – 6 hours from the start of collection Postoperative autotransfusion with or without processing – 6 hours from start of collection “Single-patient use materials intended to produce a postoperative product shall be used for no more than 24 hours after coming into contact with a patient’s blood at room temperature.” 5th Edition, AABB Standards for Perioperative Autologous Blood Collection and Administration, Reference Standard 5.1.8A, pp. 22-23

“Product Quality” Per AABB Standards for Perioperative Autologous Blood Collection and Administration, 5th Edition, January 1, 2013 Adequately trained and qualified operators Periodic measurement of washout markers Bacterial measurement “little correlation is found with adverse clinical sequelae” Frequent measurement of hematocrit or hemoglobin concentrations AABB Guidelines 2010, pp. 4-5

PBMT Exam PBMT - Perioperative Blood Management Technologist Created and maintained by IBBM (International Board of Blood Management) via AmSECT Used to be given in conjunction with AmSECT Meetings Is now available for proctored on-line testing Consistent operator competencies Recognized by aaBB Will most likely be mandated in the future by liability insurers Annual recertification is already a regulatory requirement per aaBB, CAP, CLIA, FDA, Joint Commission and state Health Departments PBMS – Perioperative Blood Management Specialist will be next for balloon pumps, PRP, etc.

Conclusion All facilities and services performing autotransfusion activities must have the November 2010, AABB Guidelines for Blood Recovery and Reinfusion in Surgery and Trauma as well as the January 1, 2013 AABB Standards for Perioperative Autologous Blood Collection and Administration in their possession Understanding the relative versus absolute contraindications to autotransfusion as described in the 2010 AABB Guidelines is very important Few complications are associated with autotransfusion and can be mitigated by appropriate practices and training Appropriate and adequate anticoagulation during autotransfusion will directly impact the quality of the final washed, recovered red blood cells Autotransfusion is a highly effective source of autologous blood and helps to conserve the allogeneic blood supply

Conclusion Allogeneic blood is still in very short supply The cost of blood has increased dramatically Patients who are transfused with allogeneic blood experience more adverse consequences than patients not receiving donor blood “High Risk” patients require greater effort Autotransfusion is both a very good clinical practice as well as a very good business practice In non-cardiovascular surgeries a variety of personnel may operate autotransfusion devices Autotransfusion is a highly visible and critical function All operators of autotransfusion devices need to be trained and credentialed on a recurring basis