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Patient Blood Management Building your foundation TRUDI GALLAGHER RN JURISDICTIONAL PATIENT BLOOD MANAGEMENT COORDINATOR FREMANTLE, WA AUSTRALIA [email protected] Patient Blood Management (PBM) is the timely application of evidence-based medical and surgical concepts designed to maintain hemoglobin concentration, optimize hemostasis and minimize blood loss in an effort to improve patient outcome. Modified from: Shander and Goodnough. Curr Opin Hematol. 2006;13(6):462-470. Blood Management All Inclusive (what’s in a name) Transfusion Free Care / “Bloodless Surgery and Medicine” Anemia Prevention Anemia Treatment Appropriate use of Blood Products Blood Conservation Discharge Anemia needs Preoperative Assessment Postoperative assessment Transfusion tracking / blood utilization Intra operative reduction of blood loss Timing Is Everything Why Is Patient Blood Management Proving To Be So Popular Among Medical Centers In 2011? Why now? Medicare “never” events Reform reimbursement unknowns Readmission issues Other timely issues Length of stay issues Infection prevention $$$$$$$ Mortality and morbidity Patient Satisfaction WHAT are regulatory directed data points Joint Commission LD.04.04.07 Clinical Practice Guidelines LD.04.01.01 thru LD.04.04.07 Leader example NPSG.01.03.01 Eliminate transfusion errors PI.01.01 The hospital collects data to monitor performance CAP TRM.41000 Transfusion Protocol: Personnel involved in transfusion are trained in the identification of transfusion recipients and blood components, and in observation of recipients during and after transfusion, with in-service education at least annually. TRM.20000 is there a written quality control program TRM.40850 does the medical director of transfusion service, review cases not meeting transfusion audit criteria AABB 9.1 blood bank has process for deviations, nonconformance related to blood 9.2.1 review of information causes of nonconformance 9.2.3 application of controls to monitor effectiveness 9.3 Quality Monitoring: process to collect and evaluate quality indicator on scheduled basis 8.2 Monitoring of blood utilization: transfusion facility monitors and addresses transfusion practices for all categories of blood and components Patient Blood Management Standards SOCIETY FOR THE ADVANCEMENT OF BLOOD MANAGEMENT sabm.org http://www.sabm.org/public/standards.php Standards Committee Professional role President, Association for Blood Conservation Organ Procurement Coordinator Blood Management Specialist Blood Utilization Coordinator Blood Conservation Manager Medical Director of Transfusion Services Transfusion Service Medical Director President and CEO of Global Blood Resources Expert Reviewers Name Title Location Dr. James AuBuchon President and CEO of Puget Sound Blood Center Seattle, WA Jeffrey B Riley CCT,CCP Supervisor and Educational Coordinator CardioVas Perf Work Group Mayo Clinic Rochester, MN Dr. George J Despotis Associate Professor, Pathology, Immunology and Anesthesiology Washington Univ School of Med Saint Louis, MO Dr. James Isbister Clinical Professor of Medicine Royal North Shore Hospital of Sydney St Leonards, NSW, Australia Dr. Ira A Shulman Director of Transfusion Medicine University of Southern Ca. Los Angeles, CA Dr. Lena Napolitano Division Chief Univ Of Michigan School of Medicine Ann Arbor, MI Leadership and Program Structure (Preparing for the foundation) Platform Written mission statement Vision and values statement Scope of service (what areas are affected) Medical Patients / inpatient and outpatient Surgical Patients / in patient and preoperative Job descriptions Physician medical director Program manager Leadership and Program Structure (blueprints) Policies and procedures (standard of care housewide or service line specific?) Interdepartmental Guide practice and process Protocols and guidelines Available to the staff at all times Education program Targets Physicians, mid-level providers, nurses, pharmacists Ancillary health care staff regarding Blood management program’s goals, structure, and scope. Leadership and Program Structure (GPS) Quality and outcome measures Data collection and reporting to the hospital quality improvement committee as scheduled Administration Leadership level representation Transfusion committee or blood management Consent Process and Patient Directives Consent Process and Patient Directives Hospital-wide policy requiring written informed consent for transfusion Documents a discussion Risk Benefits Alternatives to transfusion Hospital-wide policy intent Supports and respects right of patients to decline blood transfusion Addresses the rights of patients who are minors Consent Process and Patient Directives Hospital has a document for adult patients Directive establishing the refusal of transfusion Defines alternatives/options to allogeneic transfusion • Autologous transfusion modalities • Human derived growth factors • Essential cofactors (e.g. iron, B12, and folic acid) for red cell production • Recombinant products • Factor concentrates • Blood derivatives and fractions. Consent and Patient Directives All patients have access to information regarding The risks and benefits of blood transfusion The risks and benefits of refusing a transfusion Alternatives to blood transfusion that are available and applicable to that patient A process is in place that Identify adult patients who refuse blood transfusions Consent and Patient Directives Patients with a previously executed blood refusal advance directive Confirmation process Continued desire to refuse transfusion? Obtain document and place in chart If the patient is unconscious or incapacitated, the advance directive is honored Education Alternatives to blood transfusions Medical staff and other health care providers Religious proscriptions against blood transfusion Is available to all providers Blood Administration Safety Blood Administration Safety Policies and procedures in compliance with applicable agencies College of American Pathologists requirements (CAP) AABB standards Applicable state regulations Standards of the JC Ordering blood Dispensing blood Transfusing blood Blood Administration Safety Individuals involved in administration of allogeneic blood transfusion will… Satisfy requirements Education prior to independent administration of blood products Demonstrate skills with a preceptor before acting independently Transfusion administration policies and procedures are in compliance with regulatory agencies Blood Administration Safety Qualified staff may not administer blood products without Receiving annual education, training and competency annually The hospital’s transfusion review committee reviews Near miss events Sentinel events Significant errors associated with pre-transfusion blood specimen acquisition NOTE: the hospital defines what constitutes a significant error or near miss event. Labeling Testing Ordering Release, and transfusion of blood and blood components. Review and Evaluation of the Patient Blood Management Program Review and Evaluation of the Patient Blood Management Program Provider-specific peer review of transfusion decisions Review information is available to the medical director of the patient blood management program. Review of transfusion decisions includes Determination of the clinical appropriateness of the transfusion Documentation regarding clinical indications for transfusion Recommendations for management without transfusion if transfusion was not clinically appropriate Review and Evaluation of the Patient Blood Management Program Blood use is monitored Individual clinical service as well as hospital-wide Data are analyzed Identify areas for improvement due to over- or underutilization. Blood and blood component transfusion is evaluated Metrics defined by the institution Comparison of blood utilization Transfusion practices with other institutions and published literature. Quality measures defined by the hospital Clinical efficacy and cost effectiveness of other treatment modalities; transfusion alternatives or managing coagulopathy Complacency 50% Education & Full Team Buy-in 44.8% 45% 43.2% 40.4% 40% 35% 37.1% 38.6% All Open Heart 37.7% 38.5% 36.2% 33.2% 33.1% Liberalized RAP protocol 31.5% 30% 26.0% 27.4% 25% 20% 15% 10% 5% Implemented Hct as a transfusion trigger Implemented new perfusion strategies & unblinded surgeon data 19.7% Hired Blood Conservation Coordinator 18.9% 18.1% 14.2% 13.6% 14.1% 13.6% Began 8.7% Leukoreduced PRBC only 11.4% 9.7% 7.3% 0% 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 n=550 n=630 n=568 n=571 n=530 n=514 n=538 n=471 n=480 n=448 n=496 n=498 CABG Blood Utilization Rates 50% 45% 40% 35% STS Intra Op 30% STS Post OP 25% PRMCE Overall 20% IntraOp 15% PostOp 10% 5% COAP 2009 Overall Transfusion Rate = 28.2% 0% 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Section Transfusion Rate Total Hip and Knee Replacements 18% 16.3% 16% 15.5% 14% 12% 10.8% 10% 9.8% 8.5% 8% 6% 10.7% 6.3% 4.8% 6.5% 6.6% 7.0% 4% 4.5% 5.6% 3.8% 5.1% 2% 2.8% 3.1% 2.8% 0% 1Q09 2Q09 TOTAL HIP REPLACEMENT 3Q09 4Q09 1Q10 2Q10 TOTAL KNEE REPLACEMENT 3Q10 4Q10 THR Trend 1Q11 TKR Trend Preoperative Anemia Management Preoperative Anemia Management Identify elective surgical procedures for which preoperative anemia management screening is required (eg. cases with potential for measureable blood loss) Patients who need preop screening are identified Three to four weeks prior to surgery Time to diagnose and manage anemia** NOTE: unless the surgery is of an urgent nature and must be performed sooner Screening for detecting anemia and allow diagnosis of the common causes of anemia Iron deficiency etc Preoperative Anemia Management A process ensures Laboratory data has been reviewed Patients with moderate to severe anemia Anemia of unclear etiology Additional clinical evaluation and laboratory testing A referral to a specialist is made as necessary. Outpatient treatment when clinically indicated Parenteral iron and/or erythropoietic-stimulating agents Results of preoperative anemia screening are shared with Referring surgeon Primary care physician Preoperative anemia Management Perioperative period If treated during preoperative time period = also followed in the postoperative period Ensures continued management of their anemia during their hospital admission Elective surgery is deferred and rescheduled in anemic patients when The anemia is reversible unless there is an urgent need for surgery Decision is the responsibility of the surgeon In consultation with the medical director of the patient blood management program Perioperative Autologous Blood Collection For Administration Perioperative Autologous Blood Collection For Administration Policies and procedures regarding perioperative autologous blood collection Collection modalities offered Methods for blood collection Indications and contraindications Reinfusion of the collected blood Policy and procedure for; Modifications of the blood collection and reinfusion conduits Volume of autologous blood collected Processed Reinfusion process is documented Perioperative Autologous Blood Collection For Administration If hemofiltration/ultrafiltration is performed Equipment used is consistent with the manufacturer’s instructions for the given device Modification Including is documented the rationale for the modification Labeling and storage requirements of perioperative autologous blood collections Defined/ and consistent with the current AABB standards Variation from accepted techniques is documented Including the rationale for such variation Perioperative Autologous Blood Collection For Administration Policies for the reinfusion of processed and/or unprocessed shed blood are established Quality assurance program Perioperative autologous blood collection is; Indicated, cost-efficient, effective, and safe Quality indicators are defined and monitored Variances to quality indicators Adverse effects including potential transfusion reactions Complications Patient safety factors are documented and reviewed, and appropriate action is taken Perioperative Autologous Blood Collection For Administration Personnel involved in handling of blood product collection Qualified on the basis of education and training Competency is documented and evaluated at least annually Equipment and supplies Validated before initial use Properly maintained Revalidated after any major service or repair Outsourced staff for perioperative autologous blood collection Outside provider is in compliance with this standard Acute Normovolemic Hemodilutation Acute Normovolemic Hemodilutation (ANH) Policy and procedure exists; the use of ANH Approved by the chair of anesthesiology Blood collection conduits Type of collection bag Formulation and volume of anticoagulant Site of blood collection Methods and solutions used to maintain normovolemia. Collection and storage requirements for blood collected through ANH Compliant with all applicable accreditation and FDA requirements Acute Normovolemic Hemodilutation Indications and contraindications for the use of ANH Described and include s Both patient-related and procedure -related factors Modifications of the blood collection conduits for specialized patient populations Jehovah’s witnesses Described, including the rationale for the modification The hemodynamic monitoring technique during the conduct of ANH is described Including any specialized equipment The mathematical computation of the volume of AWB blood to be collected is stated Acute Normovolemic Hemodilutation The projected end-points of autologous whole blood (AWB) collection are stated Including target hemoglobin or hematocrit Where applicable, the impact of hemodilution secondary to an extracorporeal circuit prime volume is calculated The timing and rationale for AWB reinfusion in relationship to the conduct of surgery and/or anesthesia are defined and followed. Acute Normovolemic Hemodilutation There is a quality assurance program to ensure; ANH is cost-efficient Effective and safe Training and on-going competency assessment for personnel collecting ANH units is defined Quality indicators are defined and monitored Variances to quality indicators Adverse-affects Complications Patient safety factors are reviewed and addressed by a quality improvement process Acute Normovolemic Hemodilutation The handling of the AWB product including Sterile collection Labeling requirements Storage location Storage temperature Duration of storage Need for refrigeration Agitation versus non-agitation techniques is defined and followed Any variation from accepted techniques that occur must be documented and must include the rationale for such variation Phlebotomy Blood Loss Phlebotomy Blood Loss Policies and processes that pertain to phlebotomy for diagnostic laboratory samples address Importance of reduced size and frequency of lab draws There is a mechanism for identifying patients At higher risk for transfusion Those who refuse transfusions Additional measures considered Use of microtainers Point of care testing Reduction in daily or routine labs ordered Phlebotomy Blood Loss There is a system in place for reducing blood loss from line draws Individuals who re infuse blood that is unsuitable for laboratory testing are trained and deemed competent according to policy and procedure guidelines Minimizing Blood Loss Associated With Surgery, Procedures, Underlying Medical Conditions, Antithrombotic Therapy Or Coagulopathy Minimizing Blood Loss Associated With Surgery, Procedures, Underlying Medical Conditions, Antithrombotic Therapy Or Coagulopathy Policies and procedures are defined that minimize intraoperative blood loss Guidelines for intraoperative use of pharmacologic agents; Topical sealants Topical hemostatic agents to minimize blood loss Patient blood management program medical director is actively involved in selection of; Clotting factor concentrates, topical hemostatic agents, tissue adhesives, and pharmacologic agents, including antifibrinolytic and prohemostatic agents to limit blood loss Minimizing Blood Loss Associated With Surgery, Procedures, Underlying Medical Conditions, Antithrombotic Therapy Or Coagulopathy Hospital coagulation testing services have the capability Assess and characterize hemorrhagic risk factors Assist in diagnosis of the likely etiology of coagulopathy in a bleeding patient Guidelines Encourage early definitive intervention and treatment of acute hemorrhage Early return to the operating room for source of bleeding Early referral for interventional radiology and embolization Early use of endoscopy/ colonoscopy and cystoscopy for gastrointestinal hemorrhage or genitourinary hemorrhage Minimizing Blood Loss Associated With Surgery, Procedures, Underlying Medical Conditions, Antithrombotic Therapy Or Coagulopathy Referral and consultation protocols Assist in the management of patients Anticoagulant and antithrombotic medications Patients with history of significant bleeding or coagulation abnormalities Massive Transfusion Protocol Massive Transfusion Protocol Criteria are defined Initiating and discontinuing the massive transfusion protocol In facilities without the capacity to manage patients with massive transfusion needs Guidelines for initial damage control resuscitation Rapid transport to another facility Responsibility for management of coagulopathy is defined The massive transfusion protocol includes Guidelines for transfusion of red blood cells, plasma, platelets, cryoprecipitate, and factor concentrates Massive Transfusion Protocol Laboratory testing, if available, is used to monitor the patient Acidosis Hypocalcemia Qualitative and quantitative abnormalities in coagulation Where available and clinically appropriate Peri-procedural autologous blood collection and administration is used to minimize the need for allogeneic red cells There is a mechanism for quality review of complex cases involving massive transfusion Transfusion Guidelines Transfusion Guidelines The transfusion guidelines are approved by; Institution’s medical executive committee (MEC) or Other appropriate authority of the medical staff There is an effective transfusion utilization review process Guidelines to determine if The transfusion under review was or is medically appropriate That adequate and appropriate documentation is present Review may be prospective, concurrent or retrospective If retrospective, it is timely Transfusion Guidelines The results of transfusion review are communicated Ordering provider Chief of the service or department Medical staff quality improvement or quality management committee These results are used both for Education Re-credentialing process Transfusion guidelines are; Accessible and available to ordering providers at the time they order transfusions Transfusion Guidelines The transfusion guidelines take into consideration Patient specific factors Age Diagnosis Laboratory values Hemoglobin Hematocrit Platelet count Coagulation testing Presence or absence of critical bleeding Transfusion Guidelines There is periodic review of the guidelines They remain current and relevant Promote a restrictive or conservative approach to the transfusion of blood components Are consistent with the literature and evolving standard of care in transfusion medicine and patient blood management Management Of Anemia In Hospitalized Patients Blood Management Patient Volume 160 140 120 100 2007 80 2008 2009 60 2010 2011 40 20 0 January February March April May June July August September October November December Management Of Anemia In Hospitalized Patients Clinical leaders of the blood management program have knowledge and experience in Recognition, diagnosis, and management of anemia Policy requiring “anemia” be documented as part of the early clinical assessment of all patients Protocols facilitate appropriate; Diagnosis Evaluation Management of anemia Management strategies help minimize the likelihood of transfusion Management Of Anemia In Hospitalized Patients Guidelines for the use of; Intravenous iron Erythropoietic stimulating agents (ESA’s) Hospital transfusion guidelines recommend Against transfusion in Asymptomatic Non-bleeding patients when the hemoglobin level is greater than or equal to 6.0 -8.0 gm/dl. Clinical strategies to optimize hemodynamics and oxygenation are followed before red cell transfusion is considered Management Of Anemia In Hospitalized Patients Transfusion of blood and/or components is never used for; Volume repletion Treating anemias that can be treated with specific medications When red cell transfusion is clinically indicated in the non-bleeding patient A single unit of red cells is prescribed at a time Followed by clinical reassessment of the patient FINANCIALS Definitions of price graphic: “DIRECT COST OF PRODUCT”: • includes price PRMCE pays to Puget Sound Blood Center • portion of the type of Cross • portion of Leukoreduction fees parallel to overall % of RBC’s affected •This does not reflect • time on the staff, documentation, storage or transportation. (**see citation below) Calculate the direct cost of the product to a center by multiplying a factor of 5 = real cost to a center for transfusing a unit of blood. Thus a unit of blood this year cost us $1915.00 overall cost and a direct cost of $383.00 per unit. Blood product costs go up annually. **Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65. Epub 2009 Dec 9 “UNITS THAT WOULD HAVE BEEN GIVEN AT THE 2005 RATE”: We have reduced our transfusion rate by 45% in 6 years. We saved the community 17,301 units of blood (if we had continued transfusing at the 2005 rate). DEFINITIONS CONTINUED: “SAVING INCURRED THAT YEAR”: Overall savings for 6 years reduction is 4.3 million dollars. “PATIENTS”: These are all encounters (inpatient and outpatient) in 2010. I have been assured that patient census, and healthcare facility use, has reduced during 2010 throughout the region. “UNIT PER PATIENT”: Because the delegation and decision in what amount to transfuse varies so drastically, and we geographically transfuse 20% of our RBC’s on an outpatient basis; the allocation of portions of units of blood is the only way to show the slow reduction of overall transfusion rate. Therefore this is the calculated portion of a unit of blood that is assigned to each patient contact for PEMC patients YEAR UNITS OF BLOOD GIVEN UNITS THAT WOULD HAVE BEEN GIVEN AT 2005 RATE DIRECT COST OF PRODUCT TOTAL DIRECT COST FOR YEAR SAVINGS INCURRED THAT YEAR over $4.3 Mil savings in 6 years PATIENTS UNIT PER PATIENT 45% decrease in 6 years 2005 8,808 NA $146 $1,285,968 NA 179,347 .049 2006 8,014 9,699 $166 $1,330,324 $279,736 197,942 .040 2007 7,733 10,902 $177 $1,368,741 $561,054 222,506 .034 2008 7,417 11,019 $186 $1,381,416 $668,204 224,887 .032 2009 7,124 11,142 $240 $1,709,760 $964,487 227,402 .031 6,182 11,009 $383 $2,367,706 $1,848,732 224,673 .027 2010 Thank you Blood Management Perfusion Expert Edy Zelinka Director of Perfusion Services APC 425-261-4249 [email protected]