1. Premier Hospital Engagement Network: Implementing a Maternal Early Warning System (MEWS) Mary E. D’Alton, MD William C. Rappleye Professor Chair, Department of Obstetrics & Gynecology Columbia University College of Physicians & Surgeons August 7, 2014

2. Mary D’Alton, MD, FACOG, is the Willard C. Rappleye Professor and Chair, Department of Obstetrics and Gynecology at Columbia University. Dr. D’Alton received her medical degree from the National University of Ireland, and completed a residency in OG/GYN at the University of Ottawa. She completed a MFM fellowship at Tufts University School of Medicine and was a Post- doctoral Fellow in Yale University’s Perinatal Unit. In 2013, she was elected as a member of the Institute of Medicine (IOM) and was recently named chair of the Pregnancy Foundation Board.

3. Objectives  Provide an overview of the National Partnership for Maternal Safety.  Discuss why the Partnership was formed.  Identify the future activities and deliverables of the Partnership for: Venous Thromboembolism Obstetric Hemorrhage Hypertension in Pregnancy  Describe supplemental materials of the Partnership on Maternal Early Warning Criteria (triggers).

4. US Pregnancy-Related Mortality Hemorrhage Thrombotic pulmonary embolism Amniotic fluid embolism Cardiomyopathy Hypertensive disorders of pregnancy Anesthesia Cerebrovascular accident Cardiovasular conditions Noncardiovascular medical conditions Infection 0 25 35 30 20 5 15 10 Mortality (%) Berg CJ et al. Obstet Gynecol 2010.

5. The Burden of Maternal Morbidity  Reviewed Nationwide Inpatient Sample (ICD-9) for 1998-2009  Severe morbidity 12.9 per 1000 deliveries Increase in Shock, Acute Renal Failure, Pulmonary Embolus, Respiratory Distress Syndrome, Acute Myocardial Infarction, Cardiac surgery  Impacts >50,000 women each year Callaghan WM et al. Obstet Gynaecol 2012

6. Factors Increasing Maternal Mortality and Morbidity  Maternal age  Obesity  Cesarean delivery  More pregnancies in women with significant chronic medical conditions Hypertension Pregestational diabetes Congenital heart disease Organ transplant

7. Lessons learned from reviews  Hemorrhagic death 93% of all deaths were potentially preventable. Lack of appropriate attention to clinical signs of hemorrhage. Failure to restore blood volume, to act decisively with life-saving interventions.  Severe Hypertension 60% of maternal deaths were potentially preventable. Failure to control blood pressure, to recognize HELLP syndrome, to diagnosis and treat pulmonary edema.  Pulmonary Embolism “Single cause of death most amenable to reduction by systematic change in practice.” Failure to use adequate prophylaxis. Berg CJ, et al. Obstet Gynecol 2005;106:1228-34 Cantwell R, et al. BJOG 2011 Mar;118 Suppl 1:1-203 Clark, SL. Semin Perinatol 2012;36(1):42-7

8. Building Consensus  ACOG-CDC Maternal Mortality/Severe Morbidity Action Meeting occurred in Atlanta, November 2012  Participants identified key priorities:  6 multidisciplinary working groups were formed  Work product presented in New Orleans 2013 Core Patient Safety Bundles Obstetric Hemorrhage Severe Hypertension in Pregnancy Venous Thromboembolism Prevention in Pregnancy Supplemental Patient Safety Bundles Maternal Early Warning Criteria Facility Review Family and Staff Support

9. IHI Evidence-Based Care Bundles  Concept of bundles developed by Institute for Healthcare Improvement (IHI)  Goal: to help health care providers more reliably deliver the best care for patients  Provides a structured way of improving processes of care  Includes a straightforward set of evidence-based practices  When performed correctly and consistently there is a noted improvement in patient outcomes IHI. Evidence–Based Care Bundles. Available at: http://www.ihi.org/topics/bundles/http://www.ihi.org/topics/bundles/

10. Implementation  The National Partnership for Maternal Safety  The Council on Patient Safety in Women’s Health Care will: provide oversight for the implementation of the 3 safety bundles within 3 years track implementation throughout the US using lessons learned from IHI 5 Million Lives Campaign provide a platform for facilities to share best practices systematically review the impact of these initiatives  www.safehealthcareforeverywoman.org IHI. 5 Million Lives Campaign. Available at: http://www.ihi.orghttp://www.ihi.org D’Alton ME, et al. Obstet Gynecol 2014 May;123(5):973-977

11. The National Partnership for Maternal Safety American Academy of Family Physicians (AAFP) American Association of Birth Centers (AABC) American Association of Blood Banks (AABB) American Hospital Association (AHA) American College of Nurse-Midwives (ACNM) American College of Obstetricians and Gynecologists (ACOG) Association of Maternal and Child Health Programs (AMCHP) Association of State and Territorial Health Officials (ASTHO) Association of Women’s Health Obstetric and Neonatal Nurses (AWHONN) California Maternal Quality Care Collaborative (CMQCC) Centers for Disease Control and Prevention (CDC) Centers for Medicare and Medicaid Services (CMS) Cynosure Florida Perinatal Collaborative Health Resources and Services Administration (HRSA) Hospital Corporation of America (HCA) National Association of Nurse Practitioners in Women’s Health (NPWH) The Preeclampsia Foundation Premier PULSE of New York Society for Maternal and Fetal Medicine (SMFM) Society for Obstetric Anesthesia and Perinatology (SOAP) The Joint Commission (TJC)

12. The Council Formed in late 2011, the Council on Patient Safety in Women’s Health Care brings partner and subspecialty organizations together with patients under the central goal of improving health care for all women. Mission Continually improve patient safety in women’s health care through multidisciplinary collaboration that drives culture change Vision Safe health care for every woman Purpose The Council on Patient Safety in Women’s Health Care’s purpose is to reduce harm to patients by fostering: Investigation to better understand the causation of harm Programs and tools to implement patient safety initiatives Education to promote patient safety Dissemination of patient safety information A health care culture of respect, transparency, and accountability

13. Council Membership

14. Obstetric Hemorrhage Safety BundleREADINESS Hemorrhage Cart with Procedural Instructions Rapid access to hemorrhage medications Established response team Establish massive transfusion protocols Unit education, regular unit-based drills (with debriefs) RECOGNITION Assessment of hemorrhage risk Measurement of CUMULATIVE blood loss Active Management of 3rd Stage of labor RESPONSE Unit-standard, stage-based OB Hemorrhage Emergency Management Plan with checklists Support program for patients, families and staff for all significant hemorrhages REPORTING/SYSTEMS LEARNING Establish a culture of Huddle for high risk patients and Post-event Debriefs Review all serious hemorrhages for systems issues Monitor outcomes and process metrics in Perinatal QI committee Modified from Elliott Main, M.D.

15. Preeclampsia/ Severe HTN Safety Bundle READINESS Make severe hypertensive protocol familiar and easy to implement (i.e. Order sets) Rapid access to key medications (eliminate need to go to pharmacy) Unit education, regular unit-based drills (with debriefs) RECOGNITION Proper blood pressure recording Application of the 2013 ACOG hypertension diagnosis categories RESPONSE Unit-standard, Severe Hypertension and Eclampsia Management Plans with checklists Delivery planning based on ACOG Hypertension category Postpartum and Post discharge planning for close supervision Support program for patients, families and staff for all ICU admissions REPORTING/SYSTEMS LEARNING Establish a culture of Huddle for high risk patients and Post-event Debriefs Review all Severe Hypertension/ICU cases for systems issues Monitor outcomes and process metrics in Perinatal QI committee Modified from Lynn Simpson, MD, Burton Rochelson, MD and ACOG District II

16. Venous Thromboembolism Safety BundleREADINESS Thromboembolism risk assessment tools with recommendations for prophylaxis for: Outpatient prenatal care An antepartum admission A delivery hospitalization Discharge home after a delivery RECOGNITION Tools to assess thromboembolism risk at all time points during pregnancy: Medical, obstetrical, and demographic risk factors thromboembolism Recommendations for safe administration of neuroaxial anesthesia RESPONSE Protocols for dosing of prophylactic and therapeutic pharmacologic anticoagulation Recommendations for mechanical thromboprophylaxis REPORTING/SYSTEMS LEARNING Establish hospital-level protocols for obstetric thromboembolism prophylaxis Review all thromboembolism events for systems issues Monitor outcomes and process metrics

17.  Existing Joint Commission requirements:  Have a process for recognizing and responding as soon as a patient’s condition appears to be worsening.  Develop written criteria describing early warning signs of a change or deterioration in a patient’s condition and when to seek further assistance.  Based on the hospital’s early warning criteria, have staff seek additional assistance when they have concerns about a patient’s condition. Issue 44, January 26, 2010

18. D’Alton ME, Obstet Gynecol 2014;123:973-7

19. Background “In many cases in this report, the early warning signs of impending maternal collapse went unrecognized.” Causes: −Rare events. −Healthy population. −Physiologic changes of pregnancy.

20. MEOWS Vital Sign Triggers “Contact doctor if one red or two yellow scores at any one time.” Swanton, IJOA 2009; 18: 253-7

21. MEOWS Triggers Response initiated for one red or two yellow triggers: ParameterRed TriggerYellow Trigger Temperature 3835-36 Systolic BP; mmHg 160150-160 Diastolic BP; mmHg>10090-100 Heart rate 120100-120, 40-50 Respiratory rate 3021-30 Oxygen saturation<95 - Pain score-2-3 Neurological responseUnresponsive, painVoice Singh et al. Anesthesia. 2012

22. A Validation System of MEOWS Outcomes Hemorrhage Asthma exacerbation Preeclampsia Status epilepticus Infection Diabetic ketoacidosis Pulmonary embolus Myocardial infarction Central venous sinus thrombosis Pulmonary edema Stroke Anesthesia complications Other

23. A Validation System of MEOWS 673 patients scored 200 (30%) triggered an evaluation 86 (13%) met criteria for morbidity Sensitivity 89% (95% CI 81-95%) Specificity 79% (95% CI 76-82%) PPV 39% (95% CI 32-46%) NPV 98% (95% CI 96-99%) Singh et al. Anesthesia. 2012

24. Council Subcommittee on Vital Sign Triggers  Every birthing facility in the United States should adapt tools that identify maternity patients who require urgent bedside evaluation by a physician.  These tools also include differential diagnoses and potential next steps. National Maternal Safety Initiative

25. Two Essential Components Maternal Early Warning Criteria Effective Escalation Policy

26. MEWS in ACOG District II Series of meetings in 2013 with leaders from academic centers across New York State. MEWS criteria and scoring was reviewed and modified. Criteria identified when an obstetric patient should be seen promptly by a senior provider.

27. Variations in Criteria MEOWS Criteria MEWS Criteria Systolic BP; mmHg 160 Diastolic BP; mmHg >100 Heart rate; bpm 120 Respiratory rate; bpm 30 Oxygen saturation; %<95 Oliguria; mL/hr x 2h<35cc/hour x 6 hours Maternal agitation, confusion, or unresponsiveness

28. Variations in Criteria MEOWS Criteria MEWS Criteria Systolic BP; mmHg 160 Diastolic BP; mmHg >100 Heart rate; bpm 120 Respiratory rate; bpm 30 Oxygen saturation; %<95 Oliguria; mL/hr x 2h<35cc/hour x 6 hours Maternal agitation, confusion, or unresponsiveness

29. Parameters to alert physician Abnormal Vitals Values Systolic BP; mmHg 160 Diastolic BP; mmHg >100 Heart rate; beats per min 120 Respiratory rate; breaths per min 30 Oxygen saturation; % <95 Oliguria; mL/hr for >2 hours <35 Neurologic: Maternal agitation, confusion, or unresponsiveness Adapted from Singh et al. 2012

30. Differential Diagnosis Common diagnoses Rare but life-threatening diagnoses Hypertension (SBP>160 or DBP>100) Hypotension (SBP<90) Tachycardia (HR>120) Bradycardia (HR<50) Tachypnea (RR>30) Bradypnea (RR<10) Hypoxemia (SpO2<95% on room air) Oliguria ( 2 hrs) Confusion, agitation, or unresponsiveness

31. Two Essential Components Maternal Early Warning Criteria Effective Escalation Policy

32. An abnormal parameter requires: 1.Prompt reporting to a physician or other qualified clinician. 2.Prompt bedside evaluation by a physician or other qualified clinician with the ability to activate resources in order to initiate emergency diagnostic and therapeutic interventions as needed.

33. Effective Escalation Policy (cont.) An abnormal parameter requires: 3.Plan for and implementation of diagnostic work- up. 4.Close follow up by senior provider of patient’s status until:  Abnormality resolves, or  Parameter judged to be of benign etiology, or  Patient is determined to be potentially critically ill and care is escalated (rapid response, higher acuity setting).

34. Why Bedside Evaluation?  Maternal mortality reviews have illustrated the hazards of phone-based management in women developing critical illness.  Specific expectations for response times should be established at a local level based on available resources.

35. Local Implementation Need to define : 1.Who to notify 2.How to notify them 3.When and how to activate the clinical chain of command in order to ensure an appropriate response

36. Experience at Columbia  MEWS initiated August 1 st, 2013 for all antepartum and postpartum patients.  Goal: Evaluation by a senior provider (senior resident, fellow, or attending) within 15 minutes of abnormal parameter being reported.  Education programs provided to Medical Assistants, Nursing, Residents and Senior Providers  MEWS provides clear expectations for reporting and evaluation of potentially critically ill patients

37. Early Warnings 1 ABNORMAL VITAL SIGN PARAMETERS 2 3 PREVENT MAJOR MORBIDITY / CRITICAL ILLNESS?

38. Experience at Columbia/ Preliminary data Breakdowns in system can occur on any level: −Medical/nursing assistants notifying nursing of abnormal parameters −Nursing notifying providers −Providers evaluating patients −Correct diagnostic assessment −Follow up of diagnostic evaluation

39. Early Warnings 1 ABNORMAL VITAL SIGN PARAMETERS 2 3 PREVENT MAJOR MORBIDITY / CRITICAL ILLNESS?

40. Early Warnings 1 ABNORMAL VITAL SIGN PARAMETERS 2 3 PREVENT MAJOR MORBIDITY / CRITICAL ILLNESS?

41. Early Warnings 1 ABNORMAL VITAL SIGN PARAMETERS 2 3 PREVENT MAJOR MORBIDITY / CRITICAL ILLNESS?

42. Experience at Columbia Majority of alerts (>80%) were for the following parameters: −Oliguria −Severe-range hypertension −Tachycardia The protocol has thus far been associated with: −Timely bedside evaluations. −Timely administration of antihypertensives. −Timely workup for severe anemia in patients with oliguria and tachycardia.

43. Moving Forward  Robust data on improvements in process measures and outcomes.  “Lessons learned” from implementation and education for a maternal early warning system.  Can decision support be used to help midlevel providers (nurse practitioners, midwives, junior residents) evaluate these patients effectively?

44. Moving Forward  Can MEWS responses be protocolized to avoid delays in diagnosis and treatment? Severe-range hypertension ⁻Is it necessary or beneficial to wait for a senior provider evaluation before treatment? ⁻Simple algorithms for management: o ACOG District II o Hospital Corporation of America Patient with tachycardia ⁻Should any patient with new onset tachycardia (HR >120) not have a CBC performed?

45. Key Points  Delays in diagnosis contribute to a large portion of preventable maternal deaths.  Maternal Early Warning Criteria can identify potentially critically ill patients and establish standards for prompt evaluation and close follow-up.  Local implementation will depend on hospital type, provider staffing, and patient population.  Significant research opportunities exist.

46. Thank you for presentation materials: Alex Friedman MD, Columbia University Jill Mhyre MD, University of Michigan

47. www.safehealthcareforeverywoman.org Council Website