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Welcome

Perinatal Medicine 2014: An Evidence Based Approach

2:30 – 3:30 p.m.

Colleen McNally, MD

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Perinatal Medicine 2014: An Evidence Based Approach

Colleen McNally, M.D.

Chief Medical Officer

Sharp Mary Birch Hospital for Women & Newborns

Course Objectives

Enhance reliability in perinatal medicine with the incorporation of evidence based practices.

Highlight lessons learned from highly reliable organizations and adopting those methodologies to achieve perinatal safety.

Focus on Perinatal Core Measures 1-3, Post Partum hemorrhage and Maternal Early Warning Systems.

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No disclosures.

PC-01: Eliminating Elective Early Deliveries: An Update

Patients with elective vaginal deliveries or elective cesarean

sections at >= 37 and < 39 weeks completed gestation

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Enforcing the Policy: 3 Options

Hard Stop

Soft Stop

Education Only

Comparison of the Three Approaches

Baseline data for one quarter in 2007 and 2009.

Reduction of elective deliveries less than 39 weeks by 55% to 4.3%.

Significant decreases in Hard Stop and Soft Stop groups.

Largest decline in Hard Stop group (1.7%) v Soft Stop (4.3%).

Clarke et al, AJOG, nov.2010 p 449-450

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Hard Stop on the Hard Stop!

Process needed to remain in Peer Review

Liability concerns

Agree to review unblinded data in OB Supervisory

“Self Police”

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PC-01: An update

Should the rate for PC-01 be 0%?

Both documentation and coding are human processes that can result in omissions and errors.

Unanticipated outcomes?

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PC-02: NTSV Cesareans Nulliparous

Term >/= 37 weeks

Singleton

Vertex

Reporting mandated by Joint Commission as of 1/1/14

Healthy People 2020 target is 23.9%

Specifications Manual for Joint Commission National Quality Measures v2014A. http://manual.jointcommission.org/releases/TJC2014A/MIF0167.html

PC-02: NTSV The dramatic variation in NTSV rates seen in all populations studied is

striking.

Hospitals within a state and physicians within a hospital have rates with a 3-5 fold variation.

Over 60% of the variation among hospitals can be attributed to first birth labor induction rates and first birth early labor admission rates.

Labor and delivery guidelines can make a difference in labor outcomes.

Many authors have shown that physician factors, rather than patient characteristics or obstetric diagnoses are the major driver for the difference in rates within a hospital.

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NTSV Rates: A Local Approach

Provide evidence based guidelines for providers: “Safe Prevention of the Primary Cesarean Delivery”

Patient education: Early Labor Brochure.

Provide Nursing, Provider and Patient education at the same time.

Follow 5 minute Apgar scores or Unexpected Complications in Term Newborns.

Data Transparency: you cannot change what you do not know.

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True Labor vs. False Labor

PC-03: Antenatal Steroids

“Patients at risk of preterm delivery

at >/= 24 weeks and <32 weeks gestation receiving antenatal steroids

prior to delivering preterm newborns.”

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Preterm Labor

“The diagnosis of preterm labor generally is basedon the clinical criteria of regular uterine contractionsaccompanied by a change in cervical dilation,effacement or both or initial presentation with regularcontractions and a cervical dilation of at least 2cm.”

30% of PTL resolves spontaneously 50% of women hospitalized with PTL deliver at term 10% of women with PTL deliver within 7 days

ACOG Practice Bulletin, number 127, June 2012

PTL Diagnosis : It’s not that easy

Contractions occur four or more times per hour in 25% of pregnancies <32 weeks.

There are challenges to identifying women who will deliver early and providing the appropriate care to prepare the fetus for preterm birth.

If we wait to diagnosis PTL with advanced cervical dilation, we miss the opportunity to administer antenatal steroids, magnesium sulfate and transfer the mother to a higher level of care.

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An Evidence Based Approach to PTL:Standardize Assessment and

Interventions

What are the best modalities to identify patients at risk of PTB?

What interventions result in the most benefit for the preterm fetus?

What interventions do not work, cost money and may be harmful?

Preterm Labor Management: What does not work?

Bed rest, hydration and pelvic rest

Antibiotics

Maintenance Tocolysis

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Antenatal Corticosteroids (ACS): The most beneficial intervention

A single course of ACS is recommended for women between 24-34 weeks at risk of PTB within 7 days.

Even treatment less than 24 hours before delivery is associated with significant benefits.

Antenatal Corticosteroids (ACS): The most beneficial intervention

Significant reductions:

Neonatal death 30%

RDS 35%

IVH 50%

NEC 55%

NICU admissions 20%

Early systemic infections 50%

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Magnesium Sulfate

Pre-delivery administration reduces the occurrence of cerebral palsy.

Administer when PTB is anticipated before 32 weeks.

No significant prolongation of pregnancy.

Hospitals should develop uniform and specific guidelines.

PLAT: Preterm Labor Assessment Toolby the March of Dimes

“To improve perinatal health outcomes by establishing a standardized clinical pathway for the assessment and disposition of women with suspected signs and symptoms of preterm labor.”

Provides evidence based, standardized pathways.

Complements recent publications from ACOG.

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PTL Assessment Review history and prenatal record

EFM

Routine labs

Sterile speculum exam for ROM, obtain fFN

Sterile vaginal exam

TVU and / or fFN

Notify provider

TVU: Transvaginal Ultrasound

The probability of spontaneous PTB increases with decreasing cervical length (CL).

Negative predicator of PTB if CL>25-30 mm

Positive predicator if CL </=20mm

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Fetal Fibronectin (fFN)

Biomarker associated with PTB.

Positive fFN: 13-40% risk of delivery within 14 days.

Negative fFN: 0.5%-5% risk of delivery within 14 days.

Not valid for patients less 24 weeks or greater than 34 weeks.

Cannot use with vaginal bleeding, sex or SVE within 24 hours, cervix> 3cm, PPROM or bulging membranes or open cervical/vaginal lesions.

ASSESSMENT:PRETERM LABOR:• Cervix 2cm dilated and /or TVU: CL </= 20mm between 20-28 weeks or Repeat SVE notes cervical change

HIGH RISK FOR PTB: TVU is 21-24mm between 20-28 weeks and/or Positive fFN between 24-34 weeks

LOW RISK for PTB: Cervical dilation <2cm No cervical change in 2 hours TVU: CL is >/= 25mm Negative fFN

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And the benefits do not stop with mom and baby…

Reduced decision time in L+D Triage to 2 hours.

Reduced unnecessary admissions for uterine contractions.

Increased patient satisfaction.

Cost reduction (38K /month at UNC).

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Maternal Early Warning Criteria

40-50% of maternal deaths are potentially preventable.

In OB, early signs of life threatening illness can be difficult to recognize.

Early warning systems have been recommended for non OB patients for over 20 years.

Required by Joint Commission as of 2010 for all hospitalized patients.

Modified Early Obstetric Warning System (MEOWS)

Red trigger Yellow trigger

Temperature; °C < 35 or > 38 35–36

Systolic BP; mmHg < 90 or > 160 150–160 or 90–100

Diastolic BP; mmHg > 100 90–100

Heart rate; beats.min−1 < 40 or > 120 100–120 or 40–50

Respiratory rate; breaths.min−1 < 10 or > 30 21–30

Oxygen saturation; % < 95 –

Pain score – 2–3

Neurological response Unresponsive, pain Voice

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Modified Early Obstetric Warning System (MEOWS)

Recommended by 2003-2005 Saving Mother’s Lives.

Adopted by NHS in UK

Singh, et al: 676 OB patients

Sensitivity: 89% Specificity: 79%

PPD: 39% NPD: 98%

The Maternal Early Warning Criteria

National Partnership for Maternal SafetyObstetrics and Gynecology, vol 124, no.4

SBP: <90 >160 DBP >100 HR <50 >120 RR <10 >30 O2 sat <95% Oliguria <35 mL/h for >/=2 hours Maternal agitation, confusion, unresponsiveness. Pre-eclamptic patient with non-remitting

headache or SOB.

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Critical Components

Women who meet any of the criteria receive prompt bedside evaluation.

Effective communication

Who to call, how to call, when to active chain of command.

Activate OB medical emergency team or Rapid Response Team.

Post Partum Hemorrhage: Recognize, Readiness and

Response

PPH: EBL>500 cc (vaginal) and >1000 cc (cesarean) in first 24 h after delivery

1-3% deliveries

Leading cause of maternal morbidity and mortality

Transfusions post vaginal delivery: 0.5%

Transfusion post cesarean birth: 2%

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CMQCC: Safety Bundle for OB Hemorrhage

Risk Assessment Quantification of EBL Trigger Tool, Early Identification Protocol with stages Hemorrhage Cart/Kit Instruction cards for new procedures Massive Transfusion Protocol Debrief Drills

PPH: Recognition

Many known risk factors

Low: hold clot

Medium: Type and screen

High: Type and cross match

Every pregnant patient must be considered at risk for PPH and every L+D

must be prepared.

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Stage 0

Risk Assessment

Active management of the 3rd stage

Fundal massage

Oxytocin

Quantify EBL: 1 gram=1ml

Increased bleeding

Change in Vital Signs

Stage 1

Mobilize, Act, Think Activate OB Hemorrhage Protocol and

Check list Call for help IVF, uterotonics, T+C, Foley, labs, O2

saturation Weigh bloody materials Etiology, evaluation and treatment

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Stage 2

Mobilize help: 2nd OB, Blood Bank, assign tasks 2nd level uterotonics, 2nd IV, labs Move to OR Transfuse based on clinical signs, not labs Advance through procedures and other

interventions based on etiology: Intrauterine Balloon, Uterine hemostatic sutures, IR.

If EBL>1500cc, >2 units PRBC given, VS unstable or suspicion for DIC:

MOVE TO STAGE 3

Stage 3

Activate Massive Hemorrhage Protocol

High ratio of FFP to PRBC: 4:4:1

Consider cryo after 8-10 units of PRBC

Mobilize advanced team: GONC, Anesthesia, Intensivist, OR Team, Trauma surgeon

Invasive surgical techniques

rFactor VIIa

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PPH: Measures

Assessment of maternal hemorrhage risk on admission.

Number of transfusions per 1000 deliveries.

Number of massive hemorrhage: >/= 4 units of blood products.

Debrief every massive hemorrhage.

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Highly Reliable OrganizationsFew proven tools to guide hospital leaders in achieving HRO status

“Managing the Unexpected”, Karl Weick and Kathleen Sutcliffe.

“High Reliability Health Care: Getting There From Here”, Mark Chassin and Jerod Loeb, The Joint Commission.

High Reliability Organizations

Complex, hazardous environments

Consequences of errors are high

Occurrence of error is low

When patients arrive at a health care organization, they expect to leave in equal

or better health.

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Characteristics of Highly Reliable Organizations

Preoccupied with failure

Resist temptation to simplify

Sensitivity to operations

Commitment to resilience

Deference to expertise

Principle 1: Preoccupation with Failure“HROs are Never Satisfied”

Detect failure

Anticipate failure

Report failure

Focus on “what” not “who”: What can I count on?

The problem exists until proven otherwise.

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Principle 2: Reluctance to Simplify The value of weak signals is lost when details are lumped in

to crude categories.

Simplifying processes is good; simplifying explanations of errors or near misses is risky.– Belief that errors and close calls are reflections of deeper

system flaws– Need to understand deep rooted problems

Examples of oversimplification:– Re-education– We caught it this time so we will always catch it– Just write a policy– Put up a flyer to remind everyone

3. Sensitive to Operations

Constant situational awareness by leaders of systems and processes that affect patient care.

Ensure the best information is provided about a situation for decision making- Effective hand-over communications

De-briefs High degree of accountability Frequent immediate feedback Communication

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HROs Do Not Tolerate Intimidating Behavior

Common Behaviors that Undermine Operations

Failure to return pages or calls

Impatience with calls

Condescending language

Failure to use SBAR or other methods to communicate

Failure to have important information available

Avoidance

Work arounds

Strategies that Bolster Operations

Disagreement is a sign that something is being overlooked

People are familiar with operations beyond their own jobs

Leaders maintain contact with the front line

4. Commitment to Resilience: Error Containment

Leaders and staff are prepared to respond to failures:- Simulations, disaster drills, mock codes, double checks and

recovery systems.

When unexpected events occur, resilient systems improvise and quickly develop new plans.

Resources are flexed to deal with demand or workload.

Expert teamwork.

• We are not error free but errors do not disable us.

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Principle 5: Defers to Expertise(Empowerment of All)

Listen to the patient and family.

A mindset that accepts insights and recommendations from the person or people most knowledgeable about a situation – even if those people have less seniority.

Leaders to emphasize the importance of a questioning attitude for all staff.

“Collective Mindfulness”

Most compelling reason HROs stay safe.

Everyone look for and report small problems or conditions.

Prize error identification and close calls.

Careful analysis of what occurred before an event.

Look for weaknesses in safety protocols and procedures.

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