Effective Methods of Utilization Review Richard R. Gammon, M.D. - - PowerPoint PPT Presentation

Effective Methods of Utilization Review

Richard R. Gammon, M.D. Medical Director

Florida Society of Pathologists July 14, 2019

SECTION ONE

Background

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Why does use of blood products need to be monitored?

• Blood transfusion most common all‐listed

procedure performed during hospitalizations in 2010

– 11 percent of stays with procedure

• Rate of hospitalization with blood transfusion

more than doubled since 1997

3

http://hcup‐us.ahrq.gov/reports/statbriefs/sb149.pdf 07/19

• Overuse of blood transfusion has

also been listed as Choosing Wisely statement

– American Society of Hematology – Society of Hospital Medicine – Critical Care Societies Collaborative

• AABB developed set of five

recommendations with input committees and Board of Directors

Choosing Wisely Program

Transfusion 2014; 54: 2344‐2352

• 1. Don’t transfuse more units of blood than absolutely

necessary

Know the Thresholds AABB Recommendation 1

• Transfusion is not indicated until the hemoglobin

level is 7g/dL

• Hospitalized adult patients who are

hemodynamically stable

• Including critically ill patients
• Strong recommendation, moderate quality

evidence

JAMA 2016; 316: 2025‐35

Recommendation 1

• Orthopedic surgery or cardiac surgery and

those with preexisting cardiovascular disease

• Restrictive RBC transfusion threshold

hemoglobin level of 8g/dL

• Strong recommendation, moderate quality

evidence

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Recommendation 1 Does Not Apply

• Acute coronary syndrome
• Severe thrombocytopenia (patients treated for

hematological or oncological disorders who at risk of bleeding)

• Chronic transfusion–dependent anemia
• Evidence is insufficient for any recommendation

8

Reassure that patients are not going to be affected‐ Reduction in mortality using data from RCTs evaluating Hb trigger < 7g/dl

Am J Med 2014; 127:124-131

• S. Sloan FABB 06/15

• 3. Don’t routinely use blood products to reverse

warfarin

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When should you consider reversing with a blood product?

• Limb or life‐threatening bleeding

– Intracranial hemorrhage – Pericardial bleed

• Emergency surgical procedure in the next 6 hours

– Traumatic rupture of a spleen, perforated viscous, ruptured aneurysm – Not just because the surgeon has operating room time in one hour

Substantial proportion of plasma is used inappropriately to reverse warfarin

• 1. Tinmouth et al. Transfusion 2013;53:2222‐9.

Warfarin accounts for 20% of plasma use

(in the PCC/FFP era in Ontario)

• 1. Tinmouth et al. Transfusion 2013;53:2222‐9.

Intravenous vitamin K is safe

• Some clinicians (and nurses) refuse to

administer vitamin K intravenously due to the risk of anaphylaxis

• Historically, the product had castor oil…
• Risk:

– 0.04‐11/10,000 doses

Fiore et al. J Thromb Thrombolysis 2001; 11:175‐83

• Widespread misconception that subcutaneous is

better than oral despite clear evidence of inferiority

– Survey of 52 anticoagulant clinics in the USA – 25% had never used oral vitamin K

• No orally available tablet in many countries (and
• ften only 5 mg tablets)

– Oral Vitamin K is available in USA in 5 mg tablets

Vanier et al. Can J Hosp Pharm 2006;59:125‐35 Libby et al. Arch Intern Med 2002; 162: 1893‐6.

Slow to Reverse Warfarin

• Observation of effect of vitamin K on

the international normalized ratio (INR) when administered subcutaneously

• Fat‐soluble compound, subcutaneous

injection slows absorption due to its solubility in subcutaneous fat

• Route of administration is least

effective

• Effectively reverses the INR when

given intravenously (IV) or orally

17

Overuse of plasma transfusion. ASCP Webinar 05/08/13 Transfusion 2012;52:45S‐55S Arch Intern Med 1999;159:2721‐4. Ann Intern Med 2002;137:251‐4 Arch Intern Med 2003;163:2469‐73

SECTION TWO

Methods of Review

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Which Best Describes the Blood Use Review Process at Your Hospital

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Jadwin D, et al. AABB 10/17

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• Time, staffing
• Reviewer bias, politics
• CPOE, limited clinical context
• Expertise, arbitration
• Feedback and Ongoing

Professional Practice Evaluation (OPPE)

Challenges With Blood‐Use Review

Transfusion 2006;46:862‐867

Prospective Review

• Verification by reviewer that criteria have

been met before a blood component is available for transfusion

• Most beneficial because occurs in real‐time

Rossi’s Principles of Transfusion Medicine. 4th ed. 2009

Prospective Review

• Transfusion order

– Reduced

• Multiple platelet transfusions with no post‐count

– Changed

• Mistaken belief that cryoprecipitate is super‐plasma

– Increased or additional components suggested

• Platelets in the setting of massive transfusion
• Undertransfusion of plasma

22

Is Undertransfusion a Problem? Plasma

• 10 US hospitals
• Medical information from the electronic

health records for 1 year (2010‐2011)

• All adult patients transfused with plasma

23

Triulzi D. Transfusion 2015; 55: 1313‐1319

Study Population

• 72,167 units of plasma were

transfused in 19,596 doses to 9,269 patients

• The median dose of was 2 units

(interquartile range, 2‐4; range 1‐ 72)

• 15% ‐1 unit
• 45% ‐ 2 units

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Suboptimal Dosing

• Previous studies have shown less than 10

mL/kg plasma results in inadequate INR correction

• Median weight‐adjusted dose was only 7.3

mL/kg

• 15.5% of doses were at least 15 mL/kg

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Prospective Review

• Ideal time to discuss appropriate transfusion practices
• r to provide effective education may not be during the

course of providing emergency care

• One issue that arises is that point‐of‐care test results

available to clinicians are likely to contribute to real‐ time transfusion decisions

• These data are not likely to be readily available to BBTS

physician

26

Transfusion Therapy: Clinical Principles and Practice, 3rd ed. 2011 AABB Technical Manual. 19th ed. 2017

Prospective Review

• Perceived it as potentially confrontational
• Offer most potential for influencing clinical

practices

• Emergency circumstances, complete information

may not be available before component release

– Member of clinical team can provide this information after emergency has been resolved – This may limit application of prospective review

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• May be most useful before the

provision of customized blood components

• Gamma irradiation or washing
• CMV negative products
• Before unusual orders

Prospective Review

Retrospective Review

• Conducted any time after transfusion
• No data to substantiate effectiveness alone in

improving transfusion practice

• Must always consider both information available

to physician as well as patient’s clinical condition at the time transfusion was prescribed

• Must be familiar with nuances of transfusion

practices

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SECTION THREE

What Works and What Does Not?

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Build Relationships Transfusion Committee

• Actively engaging one’s colleagues in decision making

can energize their interest and make them feel that decisions made are truly their own, not forced upon them (probably unsuccessfully) by transfusion service

• On physician‐to‐physician basis, transfusion service

director can impress upon colleagues importance of certain issues and need to address them

31

Transfusion 2006;46:862‐867.

Build Relationships

• At same time, he or she can impress them

with valuable information that can improve patient care

• By using the committee for more than just

“blood utilization review,” transfusion service can win many friends and establish new conduits for communication and cooperation

32

Clinical Management From The Laboratory

• Many clinical situations develop that require

an unusual or nonstandard response

• Problems that fit in this category include

broad range of complexity, urgency, and frequency

33

Interactions with Physicians in Real‐Time

• Huge impact on clinical practice can be made

through interactions surrounding clinicians’ decisions whether to transfuse blood component

• Prospective audits more effectively shape
• rdering habits of clinicians

34

Requirements

• Availability to be interrupted without notice
• Proficiency with literature defining the

appropriate indications for transfusion

• Willingness to insert oneself into clinical

situation where clinician may have expected his or her “order” to be filled without question

35

Interactions with Physicians in Real‐Time

• Successful interactions are promoted if expertise
• f the TM physician is well known and his or her

ability to provide assistance in transfusion matters has already been demonstrated

• Communications approaches are needed that can

diffuse potentially tense situation where defensiveness is unlikely to aid objectivity

36

Interactions with Physicians in Real‐Time

• Starting off conversation with, “Yes, we have the

plasma thawing, but I wanted to learn a little more about the problem you’re dealing with,” can quickly defuse tension

• Offering to thaw but hold plasma until oozing is

actually evident may allow reticent surgeon

• pportunity to (perhaps grudgingly) try it “your

way.”

37

Interactions with Physicians in Real‐Time

• Inquiring how prospective PLT recipient is

tolerating his or her chemotherapy and asking about bleeding problems can demonstrate your interest in patient’s welfare

• Successful implementation of rigorously defined

transfusion indications has potential to earn one moniker such as “Plasma Police,”

• Patients will be the better for one’s efforts

38

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• Usual practice – defer to ordering

physician

– More familiar with patient’s clinical condition – Caveat‐ as long as not potential for immediate adverse effect on patient

• Refer to transfusion committee for

further review

Case of Disagreement – Ordering vs. Reviewing Physician

www.nesslerlaw.com 07/19 AABB Technical Manual. 19th ed. 2017

Clinical Management At the Bedside

• Successful Transfusion Medicine physician is

valuable clinician at bedside

• Even without formal fellowship training, average

pathologist knows far more about components and literature regarding their use than internist or surgeon

• Sharing this knowledge in supportive, collegial

manner promotes optimal patient care

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Dealing With Massive Transfusion Episodes

• Transfusion Medicine specialist
• Martial a broad understanding of physiology
• f acute blood loss
• Assist resuscitation of bleeding patient

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• Prevention of dilutional

coagulopathy more effective in avoiding morbidity than attempting to recover after its

• nset
• Accurate anticipation requires

comprehension of etiology of problem and an understanding of likely clinical course

Dealing With Massive Transfusion Episodes

www.emcrit.org 07/19 J Trauma Acute Care Surg 2017; 82:S41‐S49 J Stubbs – ABC Meeting Presentation – 03/18

Two Randomized Controlled Trials

Hess J. AABB PBM Webinar 10/09/14 Injury 2014:45:1287‐1295 JAMA 2015; 313:471‐482

JAMA Surg. 2013;148(2):127‐136 AABB Audioconference 12/12/12

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• Providing treatment for oxygen

debt and coagulopathy of trauma

• More concentrated product

compared to reconstituting WB

• Contains PLTs that appear to have

equivalent or better hemostatic effect

• Simplification of resuscitation

effort & ability to provide balanced resuscitation fluid in one bag

Benefits of Whole Blood

ABC Journal Club 08/07/18

Use of Whole Blood

• Recipients whose ABO group is not known or has not been confirmed shall

receive group O Red Blood Cells or low titer group O Whole Blood

• If low titer group O Whole Blood is used the BB/TS shall define low titer

group O Whole Blood and shall have policies, processes and procedures for: – The use of low titer group O Whole Blood – The maximum volume/units allowed per event – Patient monitoring for adverse effects

45

AABB Standards for Blood Banks/Transfusion Services 31st ed. 2018 ABC Journal Club 08/07/18

Maximum Number of Units‐ No Consensus

• Mayo Clinic

– No more than two units unless group O

• Centralized Transfusion Service at Pittsburgh

– Allows up to 4 units

• US Army

– No limit – Discussions between attending physicians and transfusion service medical director do occur after patient has received eight units about whether to continue with WB

Transfusion 2018; 58: 2280‐2288 Transfusion 2016; 56:S173‐S181

Transition to Component Therapy

• Based on point‐of‐care (POC) testing or near‐

patient testing

• Viscoelastic tests

– Thromboelastography (TEG) – Rotational thromboelastrometry (ROTEM)

• Other conventional laboratory tests

Transfusion 2018; 58:622‐628 OneBlood White Paper 2018

• June 2016‐June 2017
• Trauma both male and females
• O neg WB
• Signs of shock, hemorrhage with

hypotension

• ≥ 15kg and/or ≥ 3 years of age
• Maximum of 30 ml/kg
• 1 WB units kept in ED fridge for

immediate use

• 1 more kept in the blood bank
• After maximum amount of WB

administered, conventional products administered as per TEG results

What about pediatric patients?

JAMA Pediatrics 2018; 172: 491‐492

• 18 patients (8 female, 10 male)
• Mean age 10.6 ± 4.9 years
• 8 group O, 10 non‐O (all A)
• Mean # units per patient: 1.2 ± 0.4

units

• Total of 19 WB units (in whole or

in part) used

• Mean age of WB: 10.2 ± 3.1 days

Peds‐ Results

JAMA Pediatrics 2018; 172: 491‐492

Conclusions

• Preliminary data suggest WB transfusion of up

to 20 mL/kg is safe in children with severe injuries

• No evidence of hemolysis in non–group O

recipients

• No transfusion reactions were reported

JAMA Pediatrics 2018; 172: 491‐492

Recommendations

• LTOWB interchangeable with uncrossmatched RBCs, plasma and

platelets in massive transfusion protocols (MTP)

• One unit LTOWB equivalent to one RBC, one plasma and one single

donor platelet in an MTP pack

• Instead of issuing 6 RBCs, 4‐6 plasma, and 1 apheresis platelet in a

single MTP round, 6 units LTOWB may be issued

• MTP protocols should be revised to include laboratory markers for

hemolysis (e.g., LDH, total bilirubin, and haptoglobin), if not already included, with the first patient sample collected

OneBlood White Paper 2018

Recommendations

• Hemolytic markers should be collected two days

following MTP

• Transition to component therapy should be considered

when feasible, based on POC testing

• Unless D negative LTOWB is manufactured and

available, females of child‐bearing age (<50 years) should receive D negative RBCs whenever possible

• No limitations on the number of units or volume of

LTOWB transfused

OneBlood White Paper 2018

Management by Wandering Around

• Applies to consultative assistance in patient

management as well

• Periodic attendance at rounds or department

meetings in high‐blood‐use areas

– Intensive care unit or the hematology ward – Offer opportunity for questions to be asked that might

• therwise have gone unanswered

– Improving clinician knowledge as well as patient care

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Management by Wandering Around

• Basics of transfusion medicine are unknown by

clinicians

• Participation in rounds also enhances personal

contacts that lead to more ready acceptance of advice when it must be delivered by telephone

• Expands knowledge when pathologists are asked

questions to which we don’t know the answers!

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• 37.8% reported having formal

PBM program (compared to 35.9% in 2011)

• Majority of these PBM programs

(90.8%) were coordinated by medical director alone or as part

• f a team
• 71.9% reporting hospitals,
• rdering physician was required to

document clinical justification for transfusion in medical record

Patient Blood Management Programs AABB 2013 Survey

Transfusion 2016; 56: 2173‐2183

Myths ‐When to check posttransfusion labs?

RBC Dosing

• Hematocrit increased 3%
• Hemoglobin increased 1 g/dL

– In non‐bleeding, non hemolysing patients administered as single unit dose

• A posttransfusion H/H

– Obtained within 15 minutes ‐ determines if additional transfusions are indicated

57 Transfusion 1997; 37: 573-76

• Platelet count should be obtained

– Before – 10 to 60 minutes after transfusion

• Platelet count should increase by

30,000 to 60,000/uL

• Assess the adequacy of response

to transfusion

Platelets‐Pre and Post Counts

AABB Technical Manual. 19th ed. 2017

Transfusion 1988:28:66‐67

Plasma‐ Dose and Administration

• Dose

– 10 to 20 mL/kg – multiple units are acceptable – Increase coagulation factors by 20% immediately after infusion

• Post‐transfusion coagulation status‐ PT/INR, aPTT or

specific factor assays, TT or fibrinogen

• Attempting to correct coagulopathy must consider

procoagulants

– Factor VII has a biologic half‐life of 5 hours – Example: Transfusion raises activity 30 to 45%, 5 hours later halfway back to steady‐state for patient (37%)

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Patient Blood Management‐ Current State US Hospitalizations 2011 vs. 2014

• RBC transfusions

– 6.8% to 5.7% (aRR 0.83)

• Plasma transfusions

– 1.0% to 0.87% (aRR 0.87)

• Platelet transfusions

– Remained stable (aRR, 0.99)

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JAMA 2018; 319: 825‐827

Observed decreases in RBC/plasma transfusions from 2011 to 2014 may reflect

• Evidence demonstrating the safety of restricting RBC

transfusions

• PBM programs
• Conservation initiatives (e.g., cell salvage,

pharmacotherapy, improved surgical techniques)

• Advocacy from medical organizations
• Publication of transfusion guidelines

No Decrease

• RBC transfusion children
• Platelet transfusion overall
• Limited evidence to guide clinical practice

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JAMA 2018; 319: 825‐827

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First Blood Bank

Transfusion 2000; 40: 110‐113 Transfusion 2017; 57: 2652‐2563

The End…Questions

Richard.Gammon@oneblood.org 407-947-7963

Florida Society of Pathologists July 14, 2019