2008 Consensus Report Standards for Perinatal Care The safe practices are defined as: processes that should be universally used in healthcare settings to: reduce the risk of harm resulting from: • processes • systems • environments of care
Update from NQF’s 2012 Perinatal and Reproductive Health Measures • NQF is a private nonprofit organization that develops and implements a national strategy for healthcare quality measurement and reporting. • NQF analyzed the available scientific evidence to define a set of practices targeted at improving patient safety. • Endorsed 14 of 21 measures to increase perinatal safety.
Case Presentation • 29 yo @30+2 arrives from ED 4:30 pm Friday • G3 / P0, BMI = 40 • Vaginal bleeding (~500mL gush) • Hx: 2001 dx CHTN, 2008 Artificial Heart Valve • Hx: 2009 Left side CVA (Stroke) • Hospitalized twice for CHF: 2010, 2011 • Anticoagulated with Warfarin – target INR 2.5 • Medications: 3 anti-HTN agents to control BP • Bedside U/S reveals ~ 350-500mL clot (abruption) Questions: – T = 98.0 VS: • Risk factors – HR = 92 • Assessment – BP = 132/92 • SBAR – R = 20
Cardiovascular Risk • Embolic Stroke • Hemorrhagic Stroke • Clot forms in the heart • Blood vessel ruptures • Travels to the brain • Damages the brain
Heparin ▪ 2007 Dennis Quaid’s twins were given 1000-fold overdose because heparin was mis-stocked in the Automated Dispensing Cabinets (ADC) Pyxis ▪ At that time the packaging for heparin and heparin lock flush were very similar ▪ Bar code scan was developed to correct the process error Chasing Zero
Bar Code Medication Administration ▪ BCMA brings trade-offs • Human automation • Lean Approach • Procedure violation ‒ When Hard Stops fail • Work arounds • Work flow
Medication Safety Initiatives The Big Three 1. Computerized provider order entry (CPOE) 2. Bar code medication administration (BCMA) 3. Smart IV Pumps
Unfractionated Heparin ▪ for PE • Loading dose: 150 units/kg bolus • 15-25 units/kg/hr • Transition to SQ or low molecular weight heparin ▪ Side effects • Hemorrhage, hypotension ‒ Protamine sulfate 1mg neutralizes 100 units of heparin ▪ Should not exceed 50 mg ▪ Initial treatment in single dose
▪ Follow aPTT 4 hours after initiation and after dose changes ▪ Goal with heparin therapy: aPTT 1.5 -2.5 x control (60-80 seconds) ▪ Monitor coagulation lab trends ▪ Risk of epidural or spinal hematoma
Magnesium Sulfate • Mechanism – Calcium antagonist #1 Tocolytic used in the U.S. Inhibits voltage independent calcium channels at the myometrial cell surface • Efficacy – Not confirmed – Cochrane review • Rationale – Safe and familiar, neuroprotective • Safety and side effects – Flushing, nausea, blurred vision, headache, pulmonary edema, cardiac arrest - caution if creat >1.0 ACOG Practice Bulletin. #43, 2003 Iams, J. Obstetrics: Normal and Problem Pregnancies, 4th d., 2002; Preterm birth, Williams Obstetrics, 22nd ed., 2005.
Management • Magnesium sulfate given for seizure prophylaxis • 4 - 6 g loading dose → 1-2 g per hour maintenance dose ▪ Magpie trial established 1 gm/hr dose effective ▪ Controversy over whether MgSO4 is needed in mild preeclampsia when closely monitored • Treatment usually continues for 24 hours after birth • Most common preventable errors in preeclampsia mgmt leading to maternal death involved inattention to BP control and S/S of pulmonary edema Clark, S. Maternal death in the 21 st Century. Am J Obstet Gynecol , 2008
CMQCC Preeclampsia Toolkit Preeclampsia Task Force Members Maurice Druzin, MD – Stanford Larry Shields, MD – Dignity Health Elliott Main, MD – CMQCC Nancy Peterson, RNC, PNNP – CMQCC Barbara Murphy, RN – CMQCC Christine Morton, PhD – CMQCC Tom Archer, MD – UCSD Sarah Kilpatrick, MD – Cedars Sinai Ocean Berg, RN, CNS – SF General Hospital Richard Lee, MD – Univ. of Southern California Brenda Chagolla, RNC, CNS – UC Davis Audrey Lyndon PhD, RNC – UC San Francisco Holly Champagne, RNC, CNS – Kaiser Mark Meyer, MD – Kaiser SD Meredith Drews – Preeclampsia Foundation Valerie Cape – CMQCC Racine Edwards-Silva, MD – UCLA Olive View Eleni Tsigas – Preeclampsia Foundation Kristi Gabel, RNC CNS – RPPC Sacramento Linda Walsh, PhD, CNM – UC San Francisco Thomas Kelly, MD – UCSD Mark Zakowski, MD – Cedars Sinai Claire Brindis, DrPH, UCSF Alana Moore Dana Hughes, DrPH, UCSF Michael Orosco, MD ,Kaiser San Diego Development of the California Toolkit ‘Improving Health Care Response to Preeclampsia’ was funded by the California Department of Public Health (CDPH), Center for Family Health, Maternal Child and Adolescent Health (MCAH) Division, using federal Title V MCH funds. 4
Magnesium for Eclampsia ▪ 4 – 6 grams bolus over 15 -20 min per institution P&P • ACOG, CMQCC ▪ For eclampsia – use smart pump (Alaris) library ▪ 2 RN check ▪ RN remains at bedside for duration of bolus (staffing?) • Antidote: Give 10% Calcium Gluconate 10ml (1 gram) slow IV push over 3 minutes ‒ Calcium Gluconate override from Pyxis ❖ may repeat every hour, if needed, up to eight doses/24 hours
Severe Preeclampsia ▪ Each institution should prepare its own medication toolbox specific to its protocols • Labetalol 20 mg IV bolus → 40mg → 80mg (max 300mg) • Hydralazine 5- 10mg doses every 15-20 minutes • Nifedipine 10 mg PO repeat every 30 minutes • Labetalol 200mg PO repeat every 30 minutes • Esmolol 1-2 mg/kg IV over 1 minute • Propofol 30-40 mg IV bolus
Magnesium Sulfate - Root Causes Conditions that make accidents more likely ▪ Different protocols, policies, procedures from one unit to another ▪ Multiple pump settings ▪ Inadequate labeling of IV fluids ▪ Not removing the Magnesium from the IV port when it is has been discontinued ▪ Thinking women on Magnesium are “stable” ▪ Assumptions and miscommunication between nurses and/or physicians
ACOG Executive Summary on Hypertension In Pregnancy, Nov 2013 1to diagnose preeclampsia with new onset hypertension. 3. The total amount of proteinuria > 5g in 24 hours has been eliminated from the diagnosis of severe preeclampsia. 4. Early treatment of severe hypertension is mandatory at the threshold levels of 160 mm Hg systolic or 110 mm Hg diastolic. The term “mild” preeclampsia is discouraged for clinical classification. The recommended terminology is: a. “ preeclampsia without severe features” (mild) b. “ preeclampsia with severe features” (severe ) 2. Proteinuria is not a requirement 18
ACOG Executive Summary on Hypertension In Pregnancy Nov 2013 5. Magnesium sulfate for seizure prophylaxis is indicated for severe preeclampsia and should not be administered universally for preeclampsia without severe features (mild). 6. Preeclampsia with onset prior to 34 weeks is most often severe and should be managed at a facility with appropriate resources for management of serious maternal and neonatal complications. 7. Induction of labor at 37 weeks is indicated for preeclampsia and gestational hypertension. 19
ACOG Executive Summary on Hypertension In Pregnancy Nov 2013 8. The postpartum period is potentially dangerous. Patient education for early detection during and after pregnancy is important. 9. Long-term health effects of magnesium should be discussed.
CMQCC Preeclampsia Toolkit Key Clinical Pearls ▪ Use of preeclampsia-specific checklists, team training and communication strategies, and continuous process improvement strategies will likely reduce hypertensive related morbidity. ▪ Use of patient education strategies, targeted to the educational level of the patients, is essential for increasing patient awareness of signs and symptoms of preeclampsia. 71
Example Case A 27 y.o was admitted to L&D with cramping, abdominal pain, vaginal bleeding and leaking of clear fluid at 27 wks In an attempt to stop preterm labor, the OB prescribed IV magnesium sulfate with a 6 g bolus dose over 30 min followed by a continuous infusion of 2g/hr A 20g/500ml bag of magnesium was used and the smart pump was programmed to deliver a continuous infusion at 12 g/hr
The rest of the story The pt. became flushed, short of breath, she called for a nurse. The pt was found felling dizzy and hypotensive and quickly proceeded to become unresponsive CPR was initiated, magnesium infusion stopped and she was given a dose of Ca Gluconate The pt responded to emergency treatment - the baby was delivered by C/S a few days later d/t unrelated preterm complications Both mom and baby were discharged w/o harm?
Common Factors in MgSO4 Deaths ▪ Use of 1,000ml IV bags w/40 g of MgSO4 ▪ Temporary removal of the IV line from the IV pump ▪ A busy unit and/or understaffing ▪ Transfer to a lower level of care ▪ Unwitnessed respiratory arrest
Monitoring Recommendations ▪ Frequently assess VS, O2 sat, DTR’s , and level of consciousness, FHR and uterine activity ▪ Assess for signs of toxicity (visual changes, somnolence, flushing, muscle paralysis, loss of patellar reflexes) or pulmonary edema and notify the MD if observed ▪ Subsequent assessment • Every 15 min for the 1 st hour • 30 min for the 2 nd hour • Hourly
Beta-Mimetic Terbutaline • Mechanism – Beta-2 stimulation → ↑ cyclic AMP, ↓ Calcium • Efficacy – May delay delivery by 2 to 7 days • Rationale 2011 FDA issues warning – Effective short-term arrest of contractions • Safety and side effects – significant and frequent – Maternal tachycardia, pulmonary edema, glucose intolerance – should only be given as inpatient – Not used as a 1 st line or with OB patients with cardiac dz – Dose – Terbutaline 0.25 mg subcutaneously only, every 2 hr x 2 ACOG Practice Bulletin. #43, 2005: Normal and Problem Pregnancies, 4th ed., 2002; Preterm birth, Williams Obstetrics, 22nd ed.
Top 10 reported medications errors in OB 1. Ampicillin 2. Oxytocin 3. Ibuprofen 4. Cefazolin 5. Oxycodone 6. Ketoralac 7. Magnesium sulfate 8. Terbutaline 9. Gentamycin 10.Meperidine Ciarkowski,S., et al. (2010)
Most common OB meds Associated with Patient Harm ▪ Oxytocin ▪ Magnesium Sulfate Terbutaline ▪ Terbutaline
Medical-legal Claims ▪ 21.9% of claims involving neurologically impaired babies ▪ 14.7% of claims involving stillbirth or neonatal death: included management of oxytocin ▪ ~ 1/2 of all paid claims involve allegation of oxytocin misuse ▪ Clark, Belfort & Dildy, (2006)
Induction of Labor Number 107, August 2009 Replaces Practice bulletin 10, Committee Opinion Numbers: 228, 248, 283 ▪ Classify indication and contraindications ▪ Describes the various agents/methods used for IOL ▪ Summarize effective agents based on outcome data ▪ Outline the requirements for safe clinical use
ACOG Recommendations ▪ Use National Institute of Child Health and Human Development (NICHD) terminology throughout the protocol ▪ Clearly explain the purpose of the protocol ▪ Describe pre-induction assessment of the patient • strongly recommend incorporating pre-induction checklist ▪ State any pre-induction documentation requirements ▪ List the contraindications to labor induction
▪ Describe the intrapartum physician and/or nursing assessment and documentation that may be required • strongly recommend utilizing a checklist as part of the ongoing assessment ▪ List the parameters for discontinuation of the induction agent ▪ Describe in detail interventions to be used if tachysystole, FHR abnormalities or other complications occur ▪ Outline the notification process of providers should the induction agents be discontinued, or when nursing interventions do not readily resolve tachysystole, fetal heart rate abnormalities or other complications
Oxytocin Checklist ▪ The use of a checklist is highly recommended when administering oxytocin. ▪ Checklists provide prerequisites at the point of patient care to safely initiate oxytocin and help to identify situations that require its discontinuation. ▪ The Hospital Corporation of America (HCA) and the Institute of Healthcare Improvement (IHI) have developed oxytocin checklists that could be incorporated into your institution’s Pitocin protocol .
“In use” oxytocin checklist HCA Perinatal Safety Initiative Recommended Oxytocin “In Use” Checklist for Women with Term Singleton- Babies ▪ “This Oxytocin “In Use” Checklist represents a guideline for care: however, individualized medical care is directed by the physician.” ▪ Checklist will be completed every 30 minutes. Oxytocin should be stopped or decreased if the following checklist cannot be completed . ▪ Date and time completed _____________
Oxytocin checklist : Fetal Assessment indicates: ▪ At least 1 acceleration of 15 bpm x 15 seconds in 30 minutes or adequate variability ▪ for 10 of the previous 30 minutes. ▪ No more than 1 late deceleration occurred. ▪ No more than 2 Variable decelerations exceeding 60 seconds in duration and ▪ decreasing greater than 60 bpm from the baseline within the previous 30 minutes.
Oxytocin checklist : Uterine Contractions ▪ No more than 5 uterine contractions in 10 minutes for any 20 minute interval ▪ No two contractions greater than 120 seconds duration ▪ Uterus palpates soft between contractions ▪ If IUPC is in place, MVU** must calculate less than 300 mm Hg and the baseline resting tone must be less than 25 mm Hg. ▪ *If Oxytocin is stopped the Pre-Oxytocin Checklist will be reviewed before Oxytocin is reinitiated. ▪ ** MVU = Montevideo Units
Results: Checklist based protocol ▪ Significant decrease in max rates of oxytocin without lengthening labor or increasing operative interventions. ▪ Newborn outcomes improved ▪ C/S rate dropped from 23.6% to 21% in 1 year ▪ A 50% decrease in adverse outcome claims
Oxytocin (Pitocin) Induction and Augmentation of Labor Policy and Procedure: BC.20 BIRTH CENTER – Pt. Care ▪ 8 Pages ▪ HISTORY OF THE POLICY • Issue Date: January 2001 ▪ VIII. APPENDIX • Appendix A: Bishop Scoring System • Appendix B: Chart of Oxytocin doses in ml/hr • Appendix C: Montevideo Units
Staffing ▪ 1:1 Nursing ▪ “ If an RN is not available to clinically evaluate the effects of the oxytocin infusion at least every 15 min, the infusion should be discontinued until that level of care is available.” ▪ ( AAP & ACOG, 2002 and AWHONN, 2002, 2010)
Staffing the Nurse: Patient Ratio ▪ 1:2 during induction/augmentation with oxytocin (AAP and ACOG Guidelines for Perinatal Care, 2007) ▪ 1:1 with high risk and active management • severe preeclampsia, during the active phase of the first stage of labor • second stage of labor. A nurse must be able to clinically evaluate the effects of oxytocin at least every 15minutes (AAP & ACOG, 2007). ▪ The oxytocin infusion should be discontinued if this level of nursing care cannot be provided. A LIP who has privileges to perform a cesarean birth should be readily available ▪ ( AAP & ACOG, 2007)
Opioids and Patient Controlled Anesthesia (PCA). 1. Prescribing safety a) Clear pain assessment b) Standardized order set 2. Dispensing safety a) Prefilled labeled syringes b) Standardized concentration 3. Administration safety a) Standardized infusion pumps (consider bar-coded technology) b) Education of patient regarding safe use of PCA c) No button use by proxy – only the patient uses the PCA button d) Independent double checks when changing syringes or changing infusion rates 4. Monitoring safety a) Continuous pulse-oximetry b) Standardized monitoring parameters c) Use sedation scores
ACOG COMMITTEE OPINION Number 447 • December 2009 (Replaces No. 286, October 2003) ▪ Efforts to reduce the occurrence of these errors should be ongoing. ▪ Computerized physician order entry systems can be effective in reducing prescribing errors, they are costly and may not collect data that support quality improvement activities. ▪ In the absence of computerized physician order entry systems, the following steps should be adopted to reduce errors in prescribing and administering medications : ▪ Improve legibility of handwriting ▪ Avoid use of nonstandard abbreviations
ACOG COMMITTEE OPINION Number 447 • December 2009 (Replaces No. 286, October 2003) ▪ Check for drug allergies and sensitivities ▪ Always use a leading 0 for doses of less than 1 unit (eg, 0.1 mg, not .1 mg), and never use a trailing 0 after a decimal (eg , 1 mg, not 1.0 mg): “always lead, never follow” ▪ All verbal orders should be written down by the individual receiving the order and read back.
Strategies used by Critical Care Nurses to Identify, Interrupt, and Correct Medical Errors Henneman, E. A., et al. (2010). ▪ To describe error recovery strategies used by critical care nurses ▪ Collected data from audio taped focus groups • 20 nurses from 5 CCU’s at 4 medical centers ▪ 17 strategies were identified • 8 Identify • 3 Interrupt • 7 Correct
Strategies Continued: Nurses use strategies to Identify Errors Henneman, E. A., et al. (2010). 1. Knowing the patient – history, plan, report, family 2. Knowing the “players” - MD, previous RN 3. Knowing the plan of care – shift report, rounds, omissions 4. Surveillance – organize room, check drips 5. Knowing policy/procedure – aware of monitoring 6. Double-checking – “they want me to do this?” 7. Using systematic processes – checklists, report forms 8. Questioning * – “Would you review the orders with me?” *Novice or Physician
Strategies Continued: IDENTIFY ERRORS Henneman, E. A., et al. (2010). Nurses used 3 strategies to interrupt errors: 1. offering assistance - help instead of confront (saving face) 2. clarifying - don’t say “no” say “why” 3. verbally interrupting - hold on – don’t do anything - stop The nurses ability to interrupt was influenced by: • experience and confidence • support of other nurses / opinion poll • fear / perceived intimidation • prior experience / regret
Strategies Continued: IDENTIFY ERRORS Henneman, E. A., et al. (2010). Nurses used 6 strategies to correct errors: 1. Persevering – unrelenting attention, phone calls, pages 2. Being physically present – face to face 3. Reviewing or confirming the plan of care – Ask “why” 4. Offering options – Can we give a one time dose? Ask “if” 5. Referencing standards or experts – reference expert/ research article 6. Involving another nurse or physician – Chain of command
Strategies Continued: IDENTIFY ERRORS Henneman, E. A., et al. (2010). ▪ Nurses reported feeling : • Frustrated • Challenged • Compelled • Push harder, chase them down, get in their face ▪ Avoided some formal leaders • Nurses or MD’s that were overly critical or intimidating ▪ Conclusion • Nursing vigilance can prevent potentially dangerous situation from reach or harming the patient
When a medication error occurs… ▪ Full disclosure of errors to patients and families • Institute policy • Must be timely • Must be complete • Institute support for those involved • Positive outcomes Institute for Safe Medication Practice (2010)
Interventions Committee – Error Review ▪ Fair and Just Culture required ▪ All “errors” tracked and catalogued, regardless of whether they reach the patient or cause harm ▪ Errors viewed as systems failures, with examination of policies, EHR functionality, workflow issues, etc. ▪ Recommendations made for templates, policies, workflow, and EHR functionality ▪ Mechanism for dealing with individuals with performance issues Institute for Safe Medication Practice (2010)
The Principles of the Program Behavioral Skills (CRM) • Know your Allocate attention Wisely environment Utilize all available • Anticipate and plan information Utilize all available • Assume the resources leadership role Call for help early • Communicate enough effectively Maintain professional • Distribute work load behavior optimally
Know Your Environment ▪ Sounds simple but it’s not ! ▪ Emergency medications or equipment that is rarely used – where found? • Triage → OR → ‒ arm boards, smart pump, pressure bags, rapid infuser ▪ Equipment and supplies move ▪ Staff vacations, relief/ float staff
Instrument & Supply Room Access to Emergency Supplies ▪ Rearranged supplies and labeled bins ▪ Stocked Emergency supplies in red bins & moved to upper shelves ▪ Re-labeled frequent use bins with known names ▪ Grouped related itemss
OB Hemorrhage Cart: 2014 ▪ Quick access to emergency supplies ▪ Refrigerator for meds ▪ Establish necessary items and par levels ▪ Label drawers/compartments ▪ Include checklists ▪ Develop process for checking and restocking ▪ Educate nursing and physician staff McNulty, 2014
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Comprehensive maternal hemorrhage protocols reduce the use of blood products and improve patient safety Shields, L., et. al., (2014) AJOG ▪ Checklist for protocol and data compliance ❑ Risk assess ❑ Correct blood bank request ❑ Quantified blood loss ❑ Correct lab results were obtained ❑ > 2 Uterotonics give w/o MD present ❑ Blood given per protocol Safehealthcareforeverywoman.org
A systematic approach to the identification and classification of near-miss events on labor and delivery in a large, national health care system Clark, S., et. al., (2012) AJOG ▪ Systematic approach to identify near-miss events on L&D • Medication errors were the highest reported ‒ Temporary verses permanent harm • MD response and decision making → Greatest potential of harm • Barriers in place to reduce harm ‒ Weaknesses (Holes) ‒ Holes align • Institutions react to harmful event → Interruption of work flow ‒ Reactive • IOM suggests voluntary reporting of near-miss ‒ Proactive
Intimidating and Disruptive Behaviors ▪ Foster medical errors ▪ Contributes to poor patient satisfaction ▪ Contributes to preventable adverse outcomes ▪ Increases the cost of care ▪ Causes qualified clinicians, administrators and managers to seek new positions in more professional environments JACHO Sentinel Event Alert, # 40, 7/08
Let’s make a Difference • Medical errors should not be criminalized • Fear is a major barrier to action • Our actions need to focus on patient safety.
Promote a Culture of Safety
Promote a Culture of Safety The people who cared for their Mom are so sorry and we’re trying to learn from our mistakes. We’re working hard with all individuals at all levels to identify safety threats, and together we’ll find answers and get better at speaking up for patients like their Mom. We promise to do our best to create hospitals that are safe places to work free of fear and retribution. And because of the courage of their Dad and his work, nurses and doctors are better able to protect patients like their Mom and we have learned from this terrible mistake and it won’t happen again.
Was “Just A Routine Operation.” ▪ Martin Bromiley lost his wife in 2007. ▪ He identifies, ‘we are all wrong no matter how good we are’. ▪ We need people around us to tell us. ▪ Be open to suggestions. Listen to your team. Step up and lead. Clear communication is key.
Summary ▪ Medication delivery is a complex multidisciplinary process. ▪ The root causes of medications errors are multifactorial. ▪ Nurses should clearly understand what constitutes a medication error. ▪ A safe non-punitive work environment is essential for errors to be accurately reported and evaluated and to bring about change. ▪ Health care providers need to work together to review errors and implement strategies that promote reliable , safe systems.
Happy Nurses’ Week! ▪ zdoggmd.com/ehr-state-of-mind/ ▪ http://zdoggmd.com/youre-welcome/
Nurses are being increasingly recognized for their role in reducing medical errors. Happy Nurses’ Week! Th Thank k You ou! Tha Thank nk yo you als u also o to to Val alerie erie Huw uwe for or he her r me ment ntorship. orship. Meghan.duck@ucsf.edu
References ▪ ACOG. (2009). Obstetrics & Gynecology . Volume 114 - Issue 6 - ppg 1424-1427 Committee Opinion No. 447: Patient Safety in Obstetrics and Gynecology. doi: 10.1097/AOG.0b013e3181c6f90e ▪ ACOG Practice Bulletin. #43, (2005). Normal and Problem Pregnancies, 4th ed., 2002; Preterm birth, Williams Obstetrics, 22nd ed. • Ciarkowski,S., et al. (2010) ▪ Clark, A. et al. (2012). Clinical Nurse Specialists. ▪ Clark, S. (2008). Maternal death in the 21 st Century. Am J Obstet Gynecol ,.
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