How Patient Safety Bundles Can Help Improve...
Transcript of How Patient Safety Bundles Can Help Improve...
Obstetric Hemorrhage:How Patient Safety Bundles Can Help
Improve Outcomes
Christian A. Chisholm, MDWendy A. Graefe, MSN, CNM
Virginia Neonatal Perinatal Collaborative
December 5, 2018
• Review the epidemiology of obstetric hemorrhage and its impact on maternal morbidity and mortality
• Discuss evidence-based strategies to mitigate the risk associated with obstetric hemorrhage
• Review strategies for readiness and response to unanticipated hemorrhage
Objectives
• Traditional definition: > 500 mL after vaginal birth, >1000 mL after cesarean
• ReVITALize definition: >1000 mL cumulative blood loss within 1st 24 hours after delivery
• Emphasis placed on
• quantity of blood loss necessary to cause physiologic instability
• extended period of risk for clinically important bleeding
• Incidence: approximately 4-5% of births
Obstetric hemorrhage - Incidence
• Uterine atony (80% of total)
• Genital tract laceration
• Abnormal placentation
• Previa
• Morbidly adherent placenta
• Abruption
• Retained placenta
• Uterine inversion
• Maternal coagulopathy
• Hereditary
• Acquired
Obstetric hemorrhage - etiologies
• Leading direct cause of maternal death worldwide
• Leading cause of severe maternal morbidity in US
• Accounts for 10% of maternal deaths in US• Survival from hemorrhage associated with
increased rates of:• Blood product transfusion
• Peripartum hysterectomy
• Critical illness: ARDS, shock, DIC, acute renal failure
Obstetric hemorrhage - impact
US Pregnancy-Related Death
Pregnancy-Related Mortality in the United States, 2006–2010
Creanga, Andreea A.; Berg, Cynthia J.; Syverson, Carla; Seed, Kristi; Bruce, F. Carol; Callaghan, William M.
Obstetrics & Gynecology125(1):5-12, January 2015.
doi: 10.1097/AOG.0000000000000564
US:
26/100,000
Other developed
countries:
12/100,000
Table 2
Causes of Pregnancy-Related Death by Outcome of Pregnancy: United States, 2006–2010
Pregnancy-Related Mortality in the United States, 2006–2010
Creanga, Andreea A.; Berg, Cynthia J.; Syverson, Carla; Seed, Kristi; Bruce, F. Carol; Callaghan, William M.
Obstetrics & Gynecology125(1):5-12, January 2015.
doi: 10.1097/AOG.0000000000000564
Copyright © 2018 by The American College of Obstetricians and Gynecologists 9
Fig. 3
Cause-specific proportionate pregnancy-related mortality: United States, 1987–2010.Creanga. Pregnancy-Related Mortality in the United States. Obstet Gynecol 2015.
Pregnancy-Related Mortality in the United States, 2006–2010
Creanga, Andreea A.; Berg, Cynthia J.; Syverson, Carla; Seed, Kristi; Bruce, F. Carol; Callaghan, William M.
Obstetrics & Gynecology125(1):5-12, January 2015.
doi: 10.1097/AOG.0000000000000564
Copyright © 2018 by The American College of Obstetricians and Gynecologists 10
• AIM Obstetric Hemorrhage Patient Safety Bundle
• Readiness
• Recognition and Prevention
• Response
• Reporting/Systems Learning
• https://safehealthcareforeverywoman.org/patient-safety-bundles/obstetric-hemorrhage/
Mitigating the Risk
• Hemorrhage cart – supplies, checklist, instructions for tamponade balloons and compression stitches
• Hemorrhage medications – kit or equivalent
• Response team [surgical backup, interventional radiology, transfusion medicine]
• Emergency release and massive transfusion protocols
• Unit education, drills, de-briefs
Readiness
Emergency Blood Release / Massive Transfusion
ORDERING BLOOD PRODUCTS
3 PATHWAYS University of Virginia Health System Aug. 2017
TYPE
TURNAROUND TIME ORDER CLINICAL GUIDELINES PRODUCT DELIVERY SYSTEM
ROUTINE < 30
minutes if no antibodies
EPIC
✓ HEMODYNAMICALLY STABLE
PATIENT AS ORDERED TUBE SYSTEM
FASTBLOOD
4+2
< 15 minutes
CALL 4-2012
To ACTIVATE
FastBlood 4+2
“One and done” →
No need to deactivate
✓ URGENT NEED
✓ ESTIMATED / PREDICTED ACUTE
BLOOD LOSS > 750 mL
✓ HEART RATE > 100 bpm
✓ SYSTOLIC BP < 100 mm Hg
✓ ABC TRAUMA SCORE 0 OR 1
4 RBC
2 FFP
NOT RECURRENT
ONE AND DONEALL IN ONE COOLER
Delivered by Transportation
MTPMASSIVE TRANSFUSION
PROTOCOL
< 15 minutes to first cooler
CALL 4-2012
To ACTIVATE MTP
CALL 4-2012
To DEACTIVATE MTP
✓ EMERGENT NEED
✓ ESTIMATED / PREDICTED ACUTE
BLOOD LOSS > 1500 mL
✓ HEART RATE > 120 bpm
✓ SYSTOLIC BP < 90 mm Hg
✓ ABC TRAUMA SCORE 2 OR
GREATER
1st COOLER
4 RBC
2 FFP
ALL IN ONE COOLER Delivered
by Transportation
2nd and SUBSEQUENT COOLERS
6 RBC
4 FFP
1 PLT
1 CRYO
• RED CELLS – in one
cooler
• FFP – in other cooler
• PLT – IN HAND (not in
cooler)
• CRYO – about every
other round – IN HAND
(not in cooler)
o Cryo is stored
frozen, so it
must be
thawed before
it is ready
• Anti-fibrinolytic agent utilized in multiple settings (trauma, orthopedics) for prevention and management of blood loss
• Prospective RCT of over 20,000 women
• Randomized to 1000 mg of TXA given over 10 minutes vs placebo
• Primary outcome was death from all causes OR hysterectomy
• not reduced by study intervention
• Death caused by hemorrhage was reduced
• (1.5% TXA vs 1.9% placebo), RR 0.81, [0.65-1.00]
• Death caused by hemorrhage (when TXA was administered within 3 hours of onset of hemorrhage) was reduced
• (1.2% TXA vs 1.7% placebo), RR 0.69, [0.52-0.91]
Tranexamic Acid (WOMAN trial results)
• Assessment of hemorrhage risk
• Measurement of cumulative blood loss
• Active management of 3rd stage of labor
• [Morbidly adherent placenta protocols]
• Although not part of the AIM bundle, MAP management protocols logically belong here
Recognition and Prevention
• Screening tools• CMQCC• AWHONN
• Adopt a screening tool and use it universally
• Identify factors which increase the risk of hemorrhage
• Communicate increased risk of specific patients to all team members• Frequent reassessment during labor and post-
partum• Consider holding standing Safety Rounds at regular
intervals
Risk screening
Oklahoma Hemorrhage Risk Assessment: Admission
Low Risk Medium Risk High Risk
No previous uterine incision Prior cesarean birth or uterine
surgery
Placenta previa, low lying placenta
Singleton pregnancy Uterine over distention ( multiple
gestation, polyhydramnios, fetus
> 4 kg)
Suspected placenta accreta,
percreta, or increta
Greater than 4 previous vaginal
births
Hematocrit less than 30% AND
other risk factors present
Less than or equal to 4 previous
vaginal births
Chorioamnionitis Platelets less than 100,000
No known bleeding disorder History of previous PPH Known coagulopathy
No history of PPH Large uterine fibroids or abnormal
uterine anatomy
Active bleeding-greater than
normal show
Plan of Care
Low Risk Medium Risk High Risk
• Type & Screen
• If prenatal antibody screen positive
(except low level anti-D from
Rhogam) – Type & Crossmatch 2
units PRBCs
• Type & Screen
• Review Hemorrhage Protocol
• Notify OB provider, anesthesia,
charge nurse, surgery
• Type & Crossmatch 2 units PRBCs
per order
• Review Hemorrhage Protocol
Identify women who may decline transfusion
• Notify OB provider for plan of care
• Early consult with anesthesia
• Review refusal of blood products protocol/consent form
Evaluate for risk factors on admission, throughout labor, first 24 hours postpartum, and at every hand off.
Oklahoma Hemorrhage Risk Assessment: Post-deliveryNotify care provider of worsening assessment. More than one medium risk factor moves patient into High Risk category.
Evaluate for risk factors on admission, throughout labor, first 24 hours postpartum, and at every hand off.Low Risk Medium Risk High Risk
Retained placenta
Cesarean birth or uterine surgery Hematocrit less than 30% AND other risk
factors present Singleton pregnancy Uterine over distention (multiple
gestation, polyhydramnios, fetus
> 4 kg)
No known bleeding disorder Greater than or equal to 5 vaginal births Platelets less than 100,000
No history of PPH History of previous PPH Known coagulopathy
Uncomplicated vaginal delivery Prolonged oxytocin use Active bleeding-more than normal lochia
No genital tract trauma Prolonged 2nd stage
Rapid labor
Large uterine fibroids or uterine anomaly
Magnesium Sulfate treatment
Genital tract trauma
Low Risk Medium Risk High Risk
Post Delivery Plan of Care
• Routine recovery
• Ongoing Quantitative Evaluation of Blood Loss
• Routine recovery with heightened awareness
for bleeding
• Ongoing Quantitative Evaluation of Blood Loss
• Type & Screen
• Review Hemorrhage Protocol
• Routine recovery with heightened awareness
for bleeding
• Ongoing Quantitative Evaluation of Blood Loss
• Notify OB provider, anesthesia, charge nurse,
surgery
• Type & Cross match 2 units PRBCs
• Review Hemorrhage Protocol
Post Recovery Plan of Care : First 24 hours
• If initial post recovery assessment is Low
Risk, reassess every 8 hours or more often
as condition necessitates.
• Reassess bleeding and fundus every 4
hours or more often as condition
necessitates
• Reassess bleeding and fundus every 4
hours or more often as condition
necessitates
Admission Risk Assessment & Testing
Low
(Clot only)
Medium
(Type and Screen)
High
(Type & Crossmatch)
No previous uterine incision
Prior cesarean birth(s) or uterine surgery
Placenta previa, low lying placenta
Singleton pregnancy Multiple gestation Suspected placenta accreta, percreta, increta
≤4 previous vaginal births
>4 previous vaginal births
Hematocrit <30 ANDother risk factors
No known bleeding disorder
Chorioamnionitis Platelets <100,000
No history of PPH History of previous PPH
Active bleeding (greater than show) on admit
Large uterine fibroids Known coagulopathy *Pre-transfusion testing strategy should be standardized to facility conditions depending
on blood bank resources, speed of testing, and availability of blood products.*
• Transfusion utilization ~1.6% of births
• Protocol options: universal T&S with crossmatch for high risk patients (highest preparation; most cost); no routine admission testing for any patient (lowest preparation, least cost); intermediate strategies
• Einerson et al (2017): cost-effectiveness analysis showed that universal T&S was not cost-effective in a wide range of scenarios; policy of “hold clot only” with crossmatch for high risk patients was most cost-effective
• Not tested in actual use; hypothetical model; cost-effectiveness was measured against prevention of emergency release blood utilization
• Bottom line – each unit should decide their standard strategy for crossmatching and apply it consistently
Blood Transfusion Readiness
• Initiation of oxytocin (IV or IM) immediately upon delivery of the anterior shoulder of the baby, either at the time of vaginal or cesarean birth
• Other components included in research and clinical protocols have included controlled cord traction and vigorous fundal massage
• Oxytocin is the key element
• Other components not proven to impact blood loss
• Compatible with delayed cord clamping
Active Management of Third Stage (AMTSL)
• AMTSL leads to reduction in the following outcomes:
• Risk of blood loss >1000 mL
• Risk of blood loss >500 mL
• Post-partum hemoglobin <9 g/L
• Mean maternal blood loss
• Maternal transfusion
• Need for use of uterotonics
Active Management of Third Stage (AMTSL)
Quantified Blood Loss
• AWHONN video (basics)• https://www.youtube.com/watch?v=F_ac-aCbEn0
• Requires system planning• Knowledge of dry weight of commonly used items (lap
pads, blue towels, chux)
• Availability of calibrated drapes and standard work surrounding the documentation
• Often integrated into EMR
• Standard, stage-based obstetric hemorrhage emergency management plan with checklists
• Support program for patients, families and staff for significant hemorrhages
Response
Hemorrhage Guidelines: Staged Responses
Pre-Admission: All patients-Assess Risk
Stage 0: All birth- Routine Measures
Stage 1: QBL > 500 mL vag or 1000 mL CS or VS unstable with continued bleeding
Stage 2: QBL 1000-1500 mL with continued bleeding
Stage 3: QBL exceeds 1500 mL
Cu
mu
lati
ve Q
BL
Active Management ofThird Stage
Every hospital will need to customize the protocol—
but the point is every hospital needs one
CMQCC OB Hemorrhage Emergency Management Plan
Copyright California Department of Public Health, 2014; supported by Title V funds. Developed in partnership with California Maternal Quality Care Collaborative Hemorrhage Taskforce Visit: www.CMQCC.org for details
Obstetric Hemorrhage Emergency Management Plan: Table Chart Format version 2.0
Assessments Meds/Procedures Blood Bank
Stage 0 Every woman in labor/giving birth
Stage 0 focuses on risk assessment and active management of the third stage.
· Assess every woman for risk factors for hemorrhage
· Measure cumulative quantitative blood loss on every birth
Active Management 3rd Stage:
· Oxytocin IV infusion or 10u IM
· Fundal Massage-vigorous, 15 seconds min.
· If Medium Risk: T & Scr
· If High Risk: T&C 2 U
· If Positive Antibody Screen (prenatal or current, exclude low level anti-D from RhoGam):T&C 2 U
Stage 1 Blood loss: > 500ml vaginal or >1000 ml Cesarean, or
VS changes (by >15% or HR ³110, BP £85/45, O2 sat <95%) Stage 1 is short: activate hemorrhage protocol, initiate preparations and give Methergine IM.
· Activate OB Hemorrhage Protocol and Checklist
· Notify Charge nurse, OB/CNM, Anesthesia
· VS, O2 Sat q5’
· Record cumulative blood loss q5-15’
· Weigh bloody materials
· Careful inspection with good exposure of vaginal walls, cervix, uterine cavity, placenta
· IV Access: at least 18gauge
· Increase IV fluid (LR) and Oxytocin rate, and repeat fundal massage
· Methergine 0.2mg IM (if not hypertensive) May repeat if good response to first dose, BUT otherwise move on to 2nd level uterotonic drug (see below)
· Empty bladder: straight cath or place foley with urimeter
· T&C 2 Units PRBCs (if not already done)
Stage 2 Continued bleeding with total blood loss under 1500ml
Stage 2 is focused on sequentially advancing through medications and procedures, mobilizing help and Blood Bank support, and keeping ahead with volume and blood products.
OB back to bedside (if not already there)
· Extra help: 2nd OB, Rapid Response Team (per hospital), assign roles
· VS & cumulative blood loss q 5-10 min
· Weigh bloody materials
· Complete evaluation of vaginal wall, cervix, placenta, uterine cavity
· Send additional labs, including DIC panel
· If in Postpartum: Move to L&D/OR
· Evaluate for special cases: -Uterine Inversion -Amn. Fluid Embolism
2nd Level Uterotonic Drugs: · Hemabate 250 mcg IM or · Misoprostol 800 mcg SL
2nd IV Access (at least 18gauge)
Bimanual massage Vaginal Birth: (typical order)
· Move to OR
· Repair any tears
· D&C: r/o retained placenta
· Place intrauterine balloon
· Selective Embolization (Interventional Radiology)
Cesarean Birth: (still intra-op) (typical order)
· Inspect broad lig, posterior uterus and retained placenta
· B-Lynch Suture
· Place intrauterine balloon
· Notify Blood Bank of OB Hemorrhage
· Bring 2 Units PRBCs to bedside, transfuse per clinical signs – do not wait for lab values
· Use blood warmer for transfusion
· Consider thawing 2 FFP (takes 35+min), use if transfusing > 2u PRBCs
· Determine availability of additional RBCs and other Coag products
Stage 3 Total blood loss over 1500ml, or >2 units PRBCs given or VS unstable or suspicion of DIC
Stage 3 is focused on the Massive Transfusion protocol and invasive surgical approaches for control of bleeding.
· Mobilize team -Advanced GYN surgeon -2nd Anesthesia Provider -OR staff -Adult Intensivist
· Repeat labs including coags and ABG’s
· Central line
· Social Worker/ family support
· Activate Massive Hemorrhage Protocol
· Laparotomy: -B-Lynch Suture -Uterine Artery Ligation -Hysterectomy
· Patient support -Fluid warmer -Upper body warming device -Sequential compression stockings
Transfuse Aggressively Massive Hemorrhage Pack
· Near 1:1 PRBC:FFP
· 1 PLT apheresis pack per 4-6 units PRBCs
Unresponsive Coagulopathy: After 8-10 units PRBCs and full coagulation factor replacement: may consult re rFactor VIIa risk/benefit
Blood Loss:
1000-1500 ml
Stage 2
Sequentially
Advance through
Medications &
Procedures
Pre-
Admission
Time of
admission
Identify patients with special consideration:
Placenta previa/accreta, Bleeding disorder, or
those who decline blood products
Follow appropriate workups, planning, preparing of resources, counseling and notification
Screen All Admissions for hemorrhage risk:
Low Risk, Medium Risk and High Risk
Low Risk: Draw blood and hold specimen
Medium Risk: Type & Screen, Review Hemorrhage Protocol
High Risk: Type & Crossmatch 2 Units PRBCs; Review Hemorrhage
Protocol
All women receive active management of 3rd
stage
Oxytocin IV infusion or 10 Units IM, 10-40 U infusion
Standard Postpartum
Management
Fundal Massage
Vaginal Birth:
Bimanual Fundal Massage
Retained POC: Dilation and Curettage
Lower segment/Implantation site/Atony: Intrauterine Balloon
Laceration/Hematoma: Packing, Repair as Required
Consider IR (if available & adequate experience)
Cesarean Birth:
Continued Atony: B-Lynch Suture/Intrauterine Balloon
Continued Hemorrhage: Uterine Artery Ligation
To OR (if not there);
Activate Massive Hemorrhage Protocol
Mobilize Massive Hemorrhage Team
TRANSFUSE AGGRESSIVELY
RBC:FFP:Plts 6:4:1 or 4:4:1
Increased
Postpartum
Surveillance
Definitive Surgery
Hysterectomy
Conservative Surgery
B-Lynch Suture/Intrauterine Balloon
Uterine Artery Ligation
Hypogastric Ligation (experienced surgeon only)
Consider IR (if available & adequate experience)
Fertility Strongly Desired
Consider ICU
Care; Increased
Postpartum
Surveillance
Verify Type & Screen on prenatal
record;
if positive antibody screen on prenatal
or current labs (except low level anti-D
from Rhogam), Type & Crossmatch 2
Units PBRCs
CALL FOR EXTRA HELP
Give Meds: Hemabate 250 mcg IM -or-
Misoprostol 600-800 SL or PO
Cumulative Blood Loss
>500 ml Vag; >1000 ml CS
>15% Vital Sign change -or-
HR ≥110, BP ≤85/45 O2 Sat <95%, Clinical Sx
Ongoing
Evaluation:
Quantification of
blood loss and
vital signs
Unresponsive Coagulopathy:
After 10 Units PBRCs and full
coagulation factor replacement,
may consider rFactor VIIa
HEMORRHAGE CONTINUES
Blood Loss:
>1500 ml
Stage 3
Activate
Massive
Hemorrhage
Protocol
Blood Loss:
>500 ml Vaginal
>1000 ml CS
Stage 1Activate
Hemorrhage
Protocol
NO
Stage 0All Births
Transfuse 2 Units PRBCs per clinical
signs
Do not wait for lab values
Consider thawing 2 Units FFP
YES
YES NO
On
go
ing
Cum
ula
tive
Blo
od
Lo
ss E
valu
ation
Cumulative Blood Loss
>1500 ml, 2 Units Given,
Vital Signs Unstable
YESIncrease IV Oxytocin Rate
Methergine 0.2 mg IM (if not hypertensive)
Vigorous Fundal massage; Empty Bladder; Keep Warm
Administer O2 to maintain Sat >95%
Rule out retained POC, laceration or hematoma
Order Type & Crossmatch 2 Units PRBCs if not already done
Activate Hemorrhage Protocol
CALL FOR EXTRA HELP
Continued heavy
bleeding
Increased
Postpartum
Surveillance
NO
NO
CONTROLLED
INCREASED BLEEDING
California Maternal Quality Care Collaborative (CMQCC), Hemorrhage Taskforce (2009) visit: www.CMQCC.org for details
This project was supported by funds received from the State of California Department of Public Health, Center for Family Health; Maternal, Child and Adolescent Health Division
Obstetric Emergency Management Plan: Flow Chart Format Release 2.0 7/9/2014
• Huddles for high risk patients, post-event debriefing to identify successes and opportunities
• Multidisciplinary review of serious hemorrhages for systems issues
• Monitor outcomes and process metrics in perinatal QI committee
Reporting/Systems Learning
• Drills, team training
• Massive transfusion protocols
• Factor replacement
Unanticipated hemorrhage
• American College of Obstetricians and Gynecologists, Postpartum Hemorrhage. Practice Bulletin 183, October 2017
• Association of Women’s Health, Obstetric and Neonatal Nurses. The AWHONN postpartum Hemorrhage Project, 2015.
• California Maternal Quality Care Collaborative, Planning for and Responding to Obstetric Hemorrhage. March 2015.
• Einerson BD et al. Transfusion preparedness strategies for obstetric hemorrhage. A cost-effectiveness analysis. ObstetGynecol 2017;130:1347-55.
• Patterson JA et al. Blood transfusion during pregnancy, birth, and the postnatal period. Obstet Gynecol2014;123:126-33.
Selected References
• Creanga AA et al. Pregnancy-related mortality in the United States 2006-2010. Obstet Gynecol 2015;125:5-12.
• WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum hemorrhage (WOMAN): an international, randomized, double-blind, placebo-controlled trial. Lancet 2017;389:2105-16.
• Begley CM et al. Active versus expectant management for women in the third stage of labour. Cochrane Database of Systematic Reviews 2015; DOI 10.1002/14651858.CD007412.pub4.
Selected References