Transcript Patient Blood Management Building your foundation

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]