An Essential Tool for Optimizing Clinical Outcomes and Improving Patient Safety: The Administrative and Clinical Standards for Patient Blood Management.

An Essential Tool for Optimizing An Essential Tool for Optimizing Clinical Outcomes and Improving Patient Safety: Clinical Outcomes and Improving Patient Safety:

The Administrative and Clinical Standards for Patient Blood Management The Administrative and Clinical Standards for Patient Blood Management Programs 2013 edition Programs 2013 edition

Trudi GallagherTrudi GallagherState Clinical Coordinator for Patient State Clinical Coordinator for Patient

Blood Management Blood Management Office of Chief Medical Officer DOHOffice of Chief Medical Officer DOH

Perth, Western AustraliaPerth, Western AustraliaAustraliaAustralia

Trudi GallagherTrudi GallagherState Clinical Coordinator for Patient State Clinical Coordinator for Patient

Blood Management Blood Management Office of Chief Medical Officer DOHOffice of Chief Medical Officer DOH

Perth, Western AustraliaPerth, Western AustraliaAustraliaAustralia

Jo ValentiDirector Blood ManagementTemple University Hospital

Philadelphia, PA USA

Jo ValentiDirector Blood ManagementTemple University Hospital

Philadelphia, PA USA

Irwin Gross, M.D.Irwin Gross, M.D.Medical DirectorMedical Director

Patient Blood ManagementPatient Blood ManagementEastern Maine Medical CenterEastern Maine Medical Center

Irwin Gross, M.D.Irwin Gross, M.D.Medical DirectorMedical Director

Patient Blood ManagementPatient Blood ManagementEastern Maine Medical CenterEastern Maine Medical Center

Conflict of Interest / Disclosure

None

Original Standards Committee Original Standards Committee (2009-2011)(2009-2011)

Purpose of a “Standard”Purpose of a “Standard” A recognized measure for comparative A recognized measure for comparative

valuevalue Quantitative valueQuantitative value Qualitative valueQualitative value

CriterionCriterion

An object that under specified conditions An object that under specified conditions cancan DefineDefine RepresentRepresent Or records the magnitude of a unitOr records the magnitude of a unit

Our original intent Our original intent (2009-2011)(2009-2011)

2009-2011 Standards Committee drafted 2009-2011 Standards Committee drafted 12 standards.12 standards.

The Foreword for the document states:The Foreword for the document states: ““These standards are intended to function These standards are intended to function

as a guide for hospitals and practitioners as a guide for hospitals and practitioners who want to optimize transfusion who want to optimize transfusion practices in order to improve patient practices in order to improve patient safety and clinical outcomes.”safety and clinical outcomes.”

NeedsNeeds

What measures do I need to establish for What measures do I need to establish for my program and have evidence of my program and have evidence of embedded PBM practice?embedded PBM practice?

How do I know that my program is How do I know that my program is complete and only requires quality complete and only requires quality adjustments or upgrades?adjustments or upgrades?

Needs Needs (cont.)(cont.)

I need a road map to direct me through I need a road map to direct me through the complicated journey of PBM the complicated journey of PBM

implementation in my institution.implementation in my institution. Would I be ready for an inspection if Would I be ready for an inspection if there were a regulatory body adopting there were a regulatory body adopting PBM measures? (present and future)PBM measures? (present and future)

Change requires upgrades Change requires upgrades and and upgrades require change upgrades require change

Guidance statement 2013 editionGuidance statement 2013 edition Intent of this document Intent of this document

Dynamic rather than static since new information Dynamic rather than static since new information is rapidly emergingis rapidly emerging

Organization-wide patient blood management Organization-wide patient blood management program should follow these standardsprogram should follow these standards

2013 edition 2013 edition Present GoalPresent Goal

Guidance document Guidance document Reflect activities related to patient blood managementReflect activities related to patient blood management

Optimize clinical outcomesOptimize clinical outcomes Improve patient safetyImprove patient safety

Long term goalLong term goal Demonstration of compliance Demonstration of compliance

SABM PBM standards may be SABM PBM standards may be used in a patient blood used in a patient blood management program management program accreditation/certification accreditation/certification processprocess

Guidance statement 2013 editionGuidance statement 2013 edition

Guidance statement 2013 editionGuidance statement 2013 edition NOTNOT intended to….. intended to…..

Provide strict indications, Provide strict indications, contraindications or other criteria for the contraindications or other criteria for the practice of clinical medicine and surgerypractice of clinical medicine and surgery

NOT to be used as the only basis for NOT to be used as the only basis for making case-specific decisions regarding making case-specific decisions regarding clinical recommendations for patient care clinical recommendations for patient care or diagnosticor diagnostic

How can this tool benefit your How can this tool benefit your program?program?

Self assessmentSelf assessment How are we doing?How are we doing?

Indicator of complianceIndicator of compliance Potential Potential

Credentialing/certification in Credentialing/certification in future?future?

Guidance for future development Guidance for future development “ “To-do list”To-do list”

Where do we go from here?Where do we go from here? What should we work on next?What should we work on next?

Benchmark for qualityBenchmark for quality Part of Network? = use as benchmark Part of Network? = use as benchmark

tool from one centre to another tool from one centre to another

Benefits of this documentBenefits of this document(cont)(cont)

2011 vs 2013 edition2011 vs 2013 edition 2013 edition2013 edition

ChangesChanges Fine tuningFine tuning

LanguageLanguage FormatFormat

Expansion and focusExpansion and focus Regulatory requirement inclusionsRegulatory requirement inclusions

If 100% of standards adopted/performed blood If 100% of standards adopted/performed blood associated regulatory agencies requirements are associated regulatory agencies requirements are coveredcovered

Consolidating old standardConsolidating old standard ANHANH

Creating new standard Creating new standard Managing anemia in non surgical Managing anemia in non surgical

outpatients (I. Gross)outpatients (I. Gross) ReferencesReferences

2011 vs 2013 edition2011 vs 2013 edition

LANGUAGE

““Acute normovolemic hemodilution (ANH) may be Acute normovolemic hemodilution (ANH) may be used as a blood conservation modality to preserve used as a blood conservation modality to preserve autologous blood and minimize or avoid allogeneic autologous blood and minimize or avoid allogeneic blood transfusion. If a hospital chooses to offer blood transfusion. If a hospital chooses to offer ANH, a standardized methodology exists for ANH, a standardized methodology exists for performing ANH in patients undergoing surgery performing ANH in patients undergoing surgery where the blood loss is anticipated to exceed 15% of where the blood loss is anticipated to exceed 15% of the patient’s blood volume.”the patient’s blood volume.”

Former #7: Acute Normovolemic Former #7: Acute Normovolemic HemodilutionHemodilution

““The hospital has the ability to collect, The hospital has the ability to collect, process, and reinfuse shed autologous process, and reinfuse shed autologous blood. The hospital may also choose to blood. The hospital may also choose to collect blood from patients in the collect blood from patients in the immediate preoperative period (acute immediate preoperative period (acute normovolemic hemodilution) for normovolemic hemodilution) for reinfusion in the perioperative period.” reinfusion in the perioperative period.”

New #7 Perioperative Autologous Blood New #7 Perioperative Autologous Blood Collection for AdministrationCollection for Administration

Goal/intentGoal/intent Decreasing blood lossDecreasing blood loss Preserving autologous blood cellsPreserving autologous blood cells Minimizing or avoiding allogeneic blood Minimizing or avoiding allogeneic blood

transfusion transfusion TimingTiming

ANH: immediately before surgery with ANH: immediately before surgery with volume replacement as appropriate volume replacement as appropriate May preserve platelets and plasma May preserve platelets and plasma

clotting factorsclotting factors

New #7 Perioperative Autologous Blood New #7 Perioperative Autologous Blood Collection for AdministrationCollection for Administration

HowHow Autologous product may be separated into Autologous product may be separated into

different components such as platelet rich different components such as platelet rich plasmaplasma Intent of creating products that further limit Intent of creating products that further limit

blood lossblood loss WhoWho

Smaller institutions choice regarding services Smaller institutions choice regarding services renderedrendered Outside contractor may be able to provide these Outside contractor may be able to provide these

servicesservices Contractor must be in compliance with this standard Contractor must be in compliance with this standard

and all policies and procedures established by that and all policies and procedures established by that hospitalhospital..

New #7 Perioperative Autologous Blood New #7 Perioperative Autologous Blood Collection for AdministrationCollection for Administration

#3 Blood Safety (e.g.. new language/indicator 2013 edition)

3.4 The hospital has a process to assess compliance with blood administration policies and procedures through direct observation by a designated Transfusion Safety Officer. If direct observation is not possible, there is retrospective evaluation of transfusion records to ensure compliance. The results of direct observation or record review are shared with the staff member who administered the blood and the medical directors of the patient blood management program and transfusion service.

3.8 Non-compliance with patient blood management policies and procedures that lead to an avoidable transfusion should be identified and reported to the patient blood management or transfusion committee as an adverse event.

#4 Review and Evaluation of the Patient Blood Management Program (e.g.. new language/indicator 2013 edition)

4.6 Compliance with patient blood management clinical protocols is monitored.

4.7 The impact of patient blood management and transfusion practice on clinical outcomes such as length of stay, infection rates, ischemic complications and mortality is evaluated.

Leadership and program structureLeadership and program structure Consent process and patient directivesConsent process and patient directives Blood administration safetyBlood administration safety Review and evaluation of the patient blood Review and evaluation of the patient blood

management programmanagement program Transfusion guidelines and peer review ofTransfusion guidelines and peer review of

transfusionstransfusions Preoperative anemia evaluation and readiness Preoperative anemia evaluation and readiness

for surgeryfor surgery

2013 Standards2013 Standards

Perioperative autologous blood collection for Perioperative autologous blood collection for AdministrationAdministration

Phlebotomy blood lossPhlebotomy blood loss Minimizing blood loss associated with surgery,Minimizing blood loss associated with surgery,

procedures and underlying medical conditionsprocedures and underlying medical conditionsincluding antithrombotic therapy, including antithrombotic therapy, antiplatelet therapy and coagulopathyantiplatelet therapy and coagulopathy

Massive transfusion protocolMassive transfusion protocol Management of anemia in hospitalized patientsManagement of anemia in hospitalized patients Managing anemia in non-surgical outpatientsManaging anemia in non-surgical outpatients

2013 Standards2013 Standards