Actionable Patient Safety Solutions #6: Hand-off Communications

Ariana Longley

and 22 collaborators

Executive Summary Checklist

Accurate and complete hand-off communications (HOC) are vital to patient safety. When HOC information is absent, incomplete, erroneous or delayed, serious patient harm may occur. The establishment of accurate, complete, timely and effective HOC requires that healthcare administration devise and support an implementation plan that includes the following actionable steps:

Hospital governance must become aware of this major performance gap as it exists in their own organization and must participate in and support the following actions.
Establish a HOC core team that includes a strong sponsor (senior clinical and administrative leadership is strongly encouraged for this role), physician champion, nursing champion and project leader. Other members include practicing physicians, nurses, therapists, technicians, and information technology experts.
Define the exact roles of the sender and receiver in each category of HOC in order to make them effective and reliable.
Educate all hospital staff on the following principles and requirements for effective HOC:

HOC occur when patient care is transferred to a different caregiver, care team, hospital unit, or patient care site. Each HOC involves a “sender” and “receiver.”
HOC failures occur when (1) the “sender” omits vital patient information from his/her report, (2) the “receiver” fails to understand or properly record vital information given by the sender or (3) the "sender" and/or "receiver" fails to manage the subject in formation in a complete accurate and/or timely manner."
A systematic complete HOC process is similar to the pre-takeoff and pre-landing procedures used by aircraft crew. Aviation has made great progress in Quality Improvement in these procedures through the use of checklists. We will use a similar approach here.
PSMF has identified nineteen different categories of HOC that commonly occur in hospitals or other care units. Each of these categories requires a specific HOC checklist. PSMF has developed 10 to date:
Emergency Department to Operating Room (Appendix A);
Hospital Unit to Home (discharge) (Appendix B);
Hospital Unit Shift Change (Appendix C);
Operating Room to Hospital Unit (Appendix D);
Operating Room to Home (Appendix E);
Hospital to Outside Care Unit (Appendix F);
Emergency Department to Surgery (Appendix G);
Hospital Unit to Outside Care Unit (Appendix H);
I-PASS Handoff Mnemonic (Appendix I);
Emergency Department to Critical Care Unit (Appendix J);
Paramedics to Emergency Department (Appendix K)

Measure the effectiveness of current HOC processes and build into performance goals

The Performance Gap

A successful patient hand-off between caregivers is defined as a transfer and acceptance of responsibility for care that is achieved through effective communication. It is a real-time process of transmitting patient-specific information from one caregiver or team to another, to ensure the continuity and safety of care. The hand-off process involves “senders” – the caregivers transmitting information and transitioning care to the next caregiver, and “receivers” – the caregivers who accept patient information and care of that patient.

HOC risk to the patient is introduced when clinicians fail to communicate patient-specific medical care and treatment information (e.g. patient’s condition, therapies and treatment plans, or any special considerations) in a complete, accurate and timely manner. Communication is both inherent and essential to patient care, and yet it is often incomplete, ineffective, or non-existent at the most crucial junctures of care. The Agency for Healthcare Research and Quality (AHRQ) reports that nearly half of hospital staff believes that patient information is lost during transfers across hospital units or during shift changes \cite{sorra2004hospital}. Breakdowns in communication were the leading root cause of sentinel events reported to The Joint Commission between 1995 and 2006 \cite{hoc1}.

Poor HOC has caused and continues to cause, preventable patient injury or death, and increased costs of care. Closing the performance gap will require healthcare organizations to commit to specific actions.

Leadership Plan

Hospital governance and senior administrative leadership must commit to becoming aware of this major performance gap in their own organization.
Hospital governance, senior administrative leadership, and clinical/safety leadership must close this performance gap by implementing a comprehensive approach to addressing hand-off communication.
Healthcare leadership must reinforce their commitment by taking an active role in championing process improvement, giving their time and attention, removing barriers, and providing necessary resources.
Leadership must demonstrate their commitment and support by shaping a vision of the future, clearly defining goals, supporting staff as they work through improvement initiatives, measuring results, and communicating progress towards goals. Actions speak louder than words. As role models, leadership must ‘walk the walk’ when it comes to supporting process improvement across an organization.
There are many types of leaders within a healthcare organization and in order for process improvement to be successful, leadership commitment and action are required at all levels. The Board, the C-Suite, senior leadership, physicians, directors, managers, and unit leaders all have important roles and must be engaged.

Change management is a critical element that must be included to sustain improvements. Recognizing the needs and ideas of the people who are part of the process—and who are charged with implementing and sustaining a new solution—is critical in building acceptance and accountability for change. A technical solution without acceptance of the proposed changes will not succeed. Building a strategy for acceptance and accountability of a change initiative increases the opportunity for success and sustainability of improvements.

“Facilitating Change,” the change management model developed by The Joint Commission developed, contains four key elements to consider while working through a change initiative for hand-off communications.

Plan the Project:

Build a strong foundation for change by assessing the culture for change, defining the change, building a strategy, engaging the right people, and painting a vision of the future. This should be done at the outset of the project.

Inspire People:

Actionable Patient Safety Solutions #14: Falls and Fall Prevention

Ariana Longley

and 10 collaborators

Executive Summary Checklist

Organizational Check: Does your organization believe patient falls is a Nursing issue, or is there accountability throughout the organization for fall prevention and protection from injury?

Fall prevention and protection from injury reduction requires an organizational understanding and commitment to safety \cite{France_2017}. A patient fall is defined as an unplanned descent to the floor, on or against some other surface, another person or object, with or without injury to the patient \cite{Morse_1989}. Creating a culture of safety within a fall initiative requires a perpetual focus on the continuous advancement of practice and safety strategies \cite{culture,trust2016}.

Healthcare administration develop, revise and support the plan through the following actionable steps: \cite{al2013,boushon2008transforming}

Assess the existing fall prevention and protection from injury policies, procedures, protocols, and educational programs in relation to current evidence and emerging research.
Identify existing needs or gaps in the fall prevention and protection from injury policies, procedures, protocols, and knowledge application for employees.
Identifying Opportunities for Improvement and Set Aims \cite{Goodwin_2014,Mion2012,mccurley2014new,Waters_2015}.

Collect fall and injury data to assist in advancing precision performance of fall prevention and protection from injury program.
Debrief all falls, including non-injury falls. Analyze for trends or patterns that assist in advancing performance of the fall prevention and protection from injury strategy.
Consider bundling evidence-based recommendations to achieve greater outcomes.
Consider provider training on how to partner with patients and their loved ones on safety strategies to prevent falls and protect from injuries.
Consider technological advancements to advance performance and reduce injuries.
Develop a multidisciplinary team to create, implement, and sustain fall prevention and protection from injury initiatives. This team should include, but is not limited to, Executive sponsor, Environmental Manager, Risk Manager, Physical Therapist, Occupational Therapist, Medical Doctor, Unit Manager, frontline nursing staff, or Certified Nursing Assistant. Efforts should be made to get as many representatives from all shifts.
Develop fall champions throughout all departments who further drive organizational knowledge and action in the healthcare setting.
Provide clear and concise communication regarding the champion's role and responsibilites.
Develop feedback mechanisms to learn what is workign and what can be improved upon in the fall prevention and protection from injury plan from the champion's perspective.

Performance Gap

Organizational Check: Does your organization understand the differences between a tool that triages and one that assesses for fall prevention and protection from injury?

Fall prevention and protection from injury is an organizational issue and needs to be addressed by all employees who might encounter a potential individual who is at risk for a fall. Consider assuring that rotations of students, volunteers and new employees understand the importance of the fall prevention and protection from injury actions. Clarity of their role and expectation of their actions must be clearly defined.

Guiding Principles related to fall prevention and protection from injury: \cite{ontario}

Actionable Patient Safety Solutions #16: Person & Family Engagement

Jacob Lopez

and 19 collaborators

Executive Summary Checklist

Person and family engagement -- often referred to as "patient" and family engagement or "PFE" -- is an underutilized resource and strategy for achieving the goal of zero harm. An effective program to optimally implement and sustain PFE should include the following actionable steps:

* Assess strengths and gaps in your organization's PFE efforts by using this checklist: Have you...

o Elicited feedback from your senior leadership team, staff, patients and families about PFE efforts?

o Inventoried policies, processes, position descriptions and training programs to determine whether PFE is included?

o Discussed findings and conclusions with leadership, staff and patients to create awareness and lay the groundwork for improvement efforts? 

* Deploy a system to implement PFE and monitor progress on improving PFE using this checklist. Did you...

o Develop an infrastructure that brings the patient and family voice systemically into your patient safety improvement work, such as:

 Appointing persons who identify as patients or patient advocates to your governing body,

 Establishing patient and family advisory bodies that contribute to organizational safety initiatives,

 Including patient advocate input into improvement committees or root cause analysis teams, and/or

 Establishing a functional area within your organization whose role and accountability is to engage patients and families?

o Select measures that will allow you to see whether processes and patient safety outcomes are changing?

o Ensure systems are in place so that needed data can be collected and shared?

o Compile results in a format that is easy to understand and monitor?

o Share results with staff, senior leadership, board, community and public?

[Adapted from Healthcare Research & Educational Trust, A Leadership Resource for Patient and Family Engagement Strategies \cite{trust}.]

The Performance Gap

Despite widespread recognition of patient safety as a public health issue since at least 1999, preventable patient harm still occurs. Estimates suggest that the problem may be getting worse not better, although arguably the larger and more alarming estimates now are a product of more effective measurement. For example, deaths due to medical error in United States hospitals were estimated at 180,000 annually by the landmark Harvard Medical Practice Study in 1984 \cite{Leape_1995}. New research in 2016 suggest that U.S. hospital deaths attributed to medical error are 250,000, making it the 3rd largest cause of preventable death . Existing research or public health data still lacks the ability to reliably estimate preventable harm due to missed, wrong or miscommunicated diagnoses. And data on harm due to medical error in non-acute care settings are still just guesses.

Whatever the estimates the challenge before us is huge and touches millions of people worldwide.

The promising news is that collaborative efforts among healthcare provider organizations, thought leaders and policymaking bodies, payors positioned to incentivize achievement of expected outcomes, innovators and researchers, educators, nonprofit/non-governmental advocacy groups, product makers and activated people who use healthcare can make a difference. Through focused attention and aligned efforts in the United States driven by the Centers for Medicare and Medicaid Services (CMS), measureable patient harm was reduced by 21% between 2010 and 2015, resulting in 125,000 few deaths, 3 million fewer injuries and $28 billion in saved costs. At the local level, collaboration between the public health sector, hospitals and outcomes improvement experts reduced hospital readmissions by 7,000 in Minnesota between 2011 and 2013, enabling patients in Minnesota to spend 28,120 nights sleeping in their own beds instead of the hospital, and helping reduce healthcare costs by more than $55 million.

PFE is an underused "natural resource" for improving the safety of care. Users of healthcare and their family members play substantial roles in managing care and often see and learn things that care providers and researchers miss. If their observations, insights and lessons learned are overlooked in safety improvement, the organization loses important opportunities to prevent harm. In a 2013 editorial, then Health Affairs Editor Susan Dentzer recognized the value of PFE in characterizing it as the "blockbuster drug" of the 21st Century, observing:

Even in an age of hype, calling something "the blockbuster drug of the century" grabs our attention. In this case, the "drug" is actually a concept--patient activation and engagement--that should have formed the heart of health care all along.

Ample evidence has accumulated demonstrating that patients who are actively engaged partners in managing their own chronic healthcare conditions achieve measurably better outcomes. Moreover, persons who use care or manage its use for loved ones are typically highly motivated to partner with their professional and organizational care providers to improve safety. Their experiences bring an urgency to the patient safety movement that propels action by generating empathy -- they engage our hearts as well as our minds and hands. In 2006 the World Health Organization captured this urgent offer to partner in the London Declaration of its Patients for Patient Safety group, a core component of its Global Patient Safety Programme :

Actionable Patient Safety Solutions #11A: Postpartum Hemorrhage (PPH)

Ariana Longley

and 15 collaborators

Executive Summary Checklist

Obstetric Hemorrhage is the most common complication in pregnancy leading to severe maternal morbidity and preventable mortality. The National Partnership for Maternal Safety, an alliance of the professional organizations of maternity care professionals and advocates, selected this safety topic for priority development and national implementation. Representative experts from these organizations developed the bundle to outline critical clinical practices that should be implemented in every maternity unit. To underscore the importance of this work. In depth description of this bundle has been simultaneously published in 5 peer reviewed journals representing the involved organizations. As will all maternal safety bundles, the Obstetric Hemorrhage bundle is organized into 4 domains: Readiness, Recognition and Prevention, Response, and Reporting and System Learning. Although the bundle components may be adapted to meet the resources available in individual facilities, standardization within an institution is strongly encouraged. References contain sample resources to assist with implementation. (http://www.safehealthcareforeverywoman.org/)

Prevention of PPH-related maternal mortality

Commitment from hospital governance and senior administrative leadership to support maternal safety initiatives like PPH in their healthcare system.

Readiness in Every Unit

Create a hemorrhage cart with supplies, checklist, and instruction cards for intrauterine balloons and compressions stitches based on the recommendations referenced \cite{2006,safemotherhood,ob3,american2014preparing,collaborative2013florida,postpartum18hemorrhage,bingham2010cmqcc}
Ensure teams have immediate access to hemorrhage medications (kit or equivalent) \cite{world2014recommendations,evanson2014postpartum,warningguidelines}
Establish a response team - who to call when help is needed (blood bank, advanced gynecologic surgery, other support and tertiary services)\cite{joint2010sentinel}
Establish massive and emergency release transfusion protocols (type-O negative/uncrossmatched)
Unit education on protocols, unit-based drills (with post-drill debriefs)

Recognition & Prevention in Every Patient

Assessment of hemorrhage risk (prenatal, on admission, and at other appropriate times)
Assessment of:

Retained placenta
Failure to progress during the second stage
Lacerations
Morbidly adherent placenta
Instrumental delivery
Large for gestational age newborn (>4000 gm)
Hypertensive disorders
Induction of labor
Prolonged 1st or second stage of labor

Measurement of cumulative blood loss (formal, as quantitative as possible)

Weigh the pads for quantitative measurement

Active management of the 3rd stage of labor (department-wide protocol)

Response

Unit-standard, stage-based, obstetric hemorrhage emergency management plan with checklists

Obstetric rapid response teams, Team Stepps.

Support program for patients, families, and staff for all significant hemorrhages

Reporting

Establish a culture of huddles for high risk patients and post-event debriefs to identify successes and opportunities
Multidisciplinary review of serious hemorrhages for systems issues
Monitor outcomes and process metrics in perinatal quality improvement (QI) committee

The Performance Gap

Global maternal deaths have fallen 44% since 1990 but still over 303,000 women die each year from complications related to pregnancy, delivery, or within the first six weeks after delivery \cite{world44a}. A majority of deaths (64%) occur from the day of delivery through 41 days postpartum \cite{Creanga_2015}. That equates to about 830 women dying every day, 550 occurring in sub-Saharan Africa, 180 in Southern Asia, and 5 in developed countries \cite{world2016global}.

Within the United States it is estimated that approximately 600 women die each year \cite{ob15}; 14.0 per 100,000 live births \cite{world2015trends}. While that number seems to pale in comparison on the global scale the US ranks 46th in the world for maternal mortality \cite{ob17}. Of all industrialized countries, the US lags behind Kazakhstan, Libya and Qatar and is one of only 13 countries whose rates have continued to decline instead of improving over the last 25 years \cite{ob18}.

A 2015 report by the United Nations (UN) agencies and World Bank Group, Trends in Maternal Mortality: 1990 to 2015, was generated to gauge whether the UN’s Millennium Development Goals would be reached.5 The 2015 target was to reduce maternal mortality by three-quarters. Only 9 of the 100 countries participating reached the 2015 goal so the new target is to reduce global average maternal death rates below 70 per 100,000 live births by the year 2030, with no country above 140 per 100,000 live births.1

The reasons for the overall increase in maternal mortality within the US are unclear. Delaying childbearing and assisted reproductive technology (ie: in-vitro fertilization) have given rise to older mothers with an increased risk of complications than younger women \cite{Jolly_2000,Bewley_2005}. Additionally, the obesity epidemic gives rise to chronic conditions such as hypertension, diabetes, and chronic heart disease increase the risk of complications during pregnancy \cite{centers2015pregnancy,Kuklina_2009,Albrecht_2010,Kuklina_2012}.

Over a third of maternal deaths in the US are preventable, 40% could be avoided if women had access to quality care \cite{Berg_2005}. Most notably, black women have a 3 to 4-fold increased risk of death due to pregnancy compared to any other race or ethnicity \cite{creanga2014racial}. The reasons are extremely complex and not well documented. Moreover, severe maternal morbidity is much more prevalent and preventable, affecting tens of thousands of women each year \cite{Callaghan_2012,Callaghan_2008}.

Postpartum Hemorrhage (PPH)

Obstetric hemorrhage remains among the leading global causes of severe maternal morbidity and mortality \cite{Callaghan_2010,Calvert_2012,Cristina_Rossi_2012}. In some developing countries, the maternal mortality rate is as high as 1 percent of live births with nearly one-fourth of those deaths being attributable to postpartum hemorrhage (PPH)\cite{abouzahr1998antepartum}. According to the most recent mortality data reported to the CDC in 2011-2012, 11% of pregnancy-related deaths in the U.S. are caused by PP \cite{BERG_1996}. Between 1994-2006, the number of PPH cases has increased more than 25 percent, potentially driven by a 50 percent increase in uterine atony.

PPH is a "low-volume, high-risk" event for birth facilities, which has led to the down-prioritization for developing standardized intervention protocol\cite{lyndon2015improving}. Limited consideration for the implementation of coordinated approaches persists despite a consistent global recognition that the lack of communication, patient engagement, and clinical intervention strategies for managing acute hemorrhage in the postpartum period lead to an increase in maternal morbidity and mortality \cite{mander2008saving,ob36}.

There are many potential causes for PPH, but chief among them is uterine atony or the inability of the uterus to contract and retract following childbirth. PPH in a previous pregnancy also can increase the risk of hemorrhage during a subsequent delivery. A contributing factor to the lack of standard coordinated approaches to PPH is the issue that there is no precise definition for the condition. Literature defines PPH as blood loss of more than 500 mL following a vaginal delivery or more than 1000 mL following a cesarean section delivery.28,\cite{ob37} PPH is also classified by time frame with Primary PPH occurring in the first twenty-four hours and secondary or late-term PPH occurring in the subsequent period.

Further, blood loss during delivery can be difficult to measure, which is attributable to lack of standardization on how to manage blood collected during childbirth as well as improvements in medical products that can absorb a deceivingly high amount of fluid. The lack of clear guidelines for measuring blood loss during childbirth often leads to underestimation and a clinician may not diagnose Primary PPH.

Population-based studies have identified some significant risk factors that may result in PPH:

Retained Placenta
Failure to Progress During the Second Stage Of Labor
Placenta Accreta, Increta, and Percreta
Lacerations
Instrumental Delivery
Large Gestational Age (LGA) Newborns
Hypertensive Disorders
Induced Labor
Augmentation of Labor With Oxytocin \cite{16272036}

Another issue that leads to the missed diagnosis of PPH is the physiological difference between expectant mothers. On average, mothers of single pregnancies have between 30-50 percent higher blood volume than a non-pregnant woman. Within the pregnant population, other blood-related physiological traits such as anemia, underlying cardiac conditions, or preeclampsia will also impact a mother's ability to tolerate blood loss.

Lack of timely and medically appropriate response to PPH is what results in poor outcomes. Early recognition of PPH and a timely, coordinated intervention are essential to reducing associated morbidity and mortality.

Leadership Plan

Individual practices, hospitals, and hospital systems should develop systems of care that deliver risk-appropriate care to women pre- and post-delivery.
Managing PPH requires a comprehensive and interdisciplinary commitment from administrative and medical leaders.
While there are prescriptive clinical interventions, highlighted in the practice plan, engaging expectant mothers and those supporting them is critical to the holistic improvement of an institution's obstetric safety including PPH.
Women with risk factors for PPH should be identified and counseled as appropriate for their level of risk and gestational age.
It is important that leaders ensure availability of resources such as personnel, equipment, blood products and trained personnel.
Establishing PPH protocols, creation of PPH kits, and appropriate training and simulation drills reduces the risk of PPH.

Practice Plan

The Council on Patient Safety in Women's Health Care developed comprehensive bundles and list of resources that apply to the prevention of harm from PPH and other maternal safety issues. The bundles are a roadmap for hospitals to use in the prevention of harm for these two pregnancy-related conditions.

It is important to remember that approach to management of PPH depends on the etiology in a patient who has had a vaginal delivery or a cesarean section. Treatment of atony depends on the route of delivery. Coagulopathies are managed medically whilst trauma-related PPH is managed surgically.

Technology Plan

Suggested practices and technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. As other options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org.

Electronic Health Record (EHR)

Web-based/EHR predictive algorithms that elicit specific data as but not limited to vital signs (BP, temp, HR, RR and SpO2), lab values, nurses notes and event reports.

Close monitoring of hemodynamics such as heart rate and blood pressure.
Ultrasound technology for assessment of retained products, retained placenta or abruption.

Metrics

Severe Maternal Morbidity among Hemorrhage Cases

Outcome Measure Formula

Numerator: Among the denominator, all cases with any SMM code

Denominator: All mothers during their birth admission, excluding extopics and miscarriages, meeting one of the following criteria:

Presence of an abruption, previa or antepartum hemorrhage diagnosis code
Presence of transfusion procedure code without a sick cell crisis diagnosis code
Presence of a postpartum hemorrhage diagnosis code

Rate is typically displayed as: All cases w/ any SMM Code/All mothers meeting denominator criteria

Metric Recommendations

Direct Impact: All Pregnant Patients

Lives Spared Harm:

Actionable Patient Safety Solutions #4: Failure to Rescue: Monitoring for Opioid-induced Respiratory Depression

Ariana Longley

and 13 collaborators

Executive Summary Checklist

Opioid induced respiratory depression is a leading cause of totally preventable patient death \cite{APSS4Cite2,APSS4Cite1,APSS4Cite3}. It also causes serious patient harm. Patients receiving opioids in the hospital have almost twice the incidence of cardiorespiratory arrest compared to other patients \cite{Overdyk_2016}. Establishing an effective program to reduce opioid-induced respiratory depression will require full hospital administration support to complete the following actionable steps:

Implement continuous electronic monitoring on all floors where patients are receiving opioid medications.
Make continuous (not spot-check) monitoring of oxygenation the care standard. At a minimum, monitoring should include continuous measure through motion and low perfusion pulse oximetry (i.e. SET, until another technology is proven to be equivalent) with a central monitoring station with direct, immediate communication to the nurse on a mobile device.
Monitor ventilation in patients receiving supplemental oxygen with either continuous capnography or acoustic respiration rate monitoring are technologies that can achieve this.
Set appropriate respiratory rate (RR) alarms and apnea alarms to minimize alarm fatigue based on the patient population and individual risk of respiratory compromise. For example, RR between 6 and 30 breaths per minute, pulse rate (PR) between 40 and 100 for adults, PR between 70-120 for pediatric patients and a lower limit of 84% for SpO2)\cite{McGrath_2016}.
Institute a rapid response notification system, which will alert staff if the patient is deteriorating. A plan for escalation of rapid response alarm to another staff member should also be in place.
Hospital governance should commit to a plan that includes:

Reviewing all reported patient deaths and serious patient harm events over the previous 24 months where opioids were involved and may have contributed to the event. A review of all previous closed malpractice claims related to opioid induced respiratory depression should also be undertaken.
Monitor and review all patients where naloxone was administered.
Identifying and prioritizing common contributing factors from those serious preventable events.
Identify and institute continuous electronic monitoring technologies that notify staff of significant changes in a patient’s respiratory condition, and ensure appropriate interventions are initiated in a timely manner.
Providing the resources necessary to implement the action plan.
Identifying a hospital “champion” who will be accountable for successful implementation, education and evaluation of the chosen plan.
Developing an educational plan for all staff, patients and family members that shares common contributing factors leading to opioid induced respiratory depression.
Implementation of a plan that eliminates current risks associated with opioids.
Continuing to report and assess both near misses and patient harm events for additional learning opportunities and improvement.

Develop a multimodal analgesic pain management program utilizing non-opioid adjuncts.
Patients and caregivers should be educated to recognize potential side effects of opioids and sedatives, and notify caregivers immediately if they occur.

The Performance Gap

Complications are inevitable and they are not always avoidable or the result of errors. However, when a patient dies because of a complication that was not recognized in a timely manner or treated appropriately, that death is preventable and is called "Failure to Rescue." Technology and knowledge now exist to anticipate and head off a serious adverse event at a time that it is preventable by an intervention. The combination of training, technology, notification and computerized data analysis will allow early intervention before a patient reaches a critical life threatening status.

Monitors now exist to detect respiratory depression as well as sepsis, hemodynamic instability, bleeding, cardiacthreats, and even the risk of patient fall at a time that an intervention can be made in time to avert a potential disaster. The development of early warning systems (EWS) has been well studied and validated in Europe and Australia \cite{Alam_2014,Ludikhuize_2012,Fullerton_2012,Smith_2013}. The technology to support EWS is now robust and can be instituted very easily into any institution. Even patients that have been discharged home can be monitored remotely.

In-hospital mortality after surgery is higher than anticipated and has multiple factors that can be systematically addressed \cite{Pearse_2012}. Healthcare leadership is largely unaware of significant improvement in technology that can detect a patient who is deteriorating and alert the caregivers prior to an adverse event occurring, such as postoperative respiratory depression.

After the Institute of Medicine described failure to rescue as a key issue in healthcare quality in 2001, failure to rescue was identified as a key area for improvement in patient safety \cite{APSS4Cite11}. A decade later, a study looked at patient safety indicators for 40 million hospitalized patients and concluded that many deaths and permanent disabilities could still be avoided if healthcare systems adopted safe practices and implemented systems that facilitate patient safety \cite{APSS4Cite12}. The following patient safety indicators accounted for 68% of all failure-to rescue patient safety events: death among surgical inpatients with serious treatable complications, pressure ulcer, postoperative respiratory failure, postoperative sepsis. The study further identified that the cost associated with postoperative respiratory failure alone in the U.S. Healthcare System is $2 billion.

While opioid use is safe for most patients, opioid analgesics are associated with adverse effects and cause respiratory depression in significant number of post-surgical patients, who often receive them for pain management \cite{Vila_2005,1,APSS4Cite15,Jarzyna_2011,APSS4Cite17}. Of opioid-related adverse drug events – including deaths – that occurred in hospitals and were reported to The Joint Commission’s Sentinel Event database (2004-2011), 47% were wrong dosing medication errors, 29% were related to improper monitoring of the patient, and 11% were related to other factors including excessive dosing, medication interactions, and adverse drug reactions.

Failure to Rescue postoperative respiratory depressions can be prevented through appropriate pain management and dosing approaches, surveillance to identify patients at risk for Failure to Rescue, notification to providers of significant changes in patient condition, and automated decision support to ensure appropriate therapies are initiated in a timely manner. A landmark study published in January 2010 by Dartmouth-Hitchcock Medical Center demonstrated that clinicians using Masimo SET® measure through motion and low perfusion pulse oximetry and Patient SafetyNet™ Remote Monitoring and Clinician Notification System identified patient distress earlier, which decreased rapid response team activations by 65%, ICU transfers by 48%, and reduce ICU days by 135 days annually \cite{Taenzer_2010}. A follow up report by Dartmouth in 2012 reported that since December 2007 no patients have died or had serious brain injuries as a result of respiratory depression from opioids. In addition, expanding monitoring to all general and thoracovascular post-surgical units produced similar results to those seen in the original orthopedic unit \cite{APSS4Cite19}. They also reported savings of $58,459 saved per patient who was not transferred to the ICU in the original orthopedic unit ($76,044 vs. $17,585), equating to $1.48 million in annual opportunity cost savings in this one unit alone.

In 2011, the Anesthesia Patient Safety Foundation recommended that all patients receiving parenteral narcotics be monitored continuously and a notification system be used to indicate to caregivers when alarming conditions occur \cite{APSS4Cite20}. In August 2012, the Joint Commission issued a sentinel event alert, urging all healthcare systems to introduce measures to improve safety for patient receiving opioids, including systematic protocols to assess pain and appropriate opioid dosing, as well as continuous monitoring of oxygenation and ventilation \cite{APSS4Cite21}. In 2014 the Center for Medicare and Medicaid Services (CMS) clarified the surgical services CoP requirement for hospitals to have adequate provisions for immediate postoperative care, to emphasize the need for postoperative monitoring for patients receiving IV opioid medications, regardless of where they are in the hospital \cite{APSS4Cite22}.

In spite of the calls to address failure to rescue for postoperative respiratory depression, pain assessment and opioid dosing approaches are variable, and a high percentage of post-surgical patients on parenteral narcotics are not monitored continuously. The lack of a systematic approach to prevent failure to rescue from postoperative respiratory depression poses significant patient safety, quality, and cost of care implications. Closing the performance gap will require hospitals and healthcare systems to commit to action in the form of specific leadership, practice, and technology plans.

Leadership Plan

The plan should include fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action \cite{APSS4Cite23}.
Hospital governance and senior administrative leadership must commit to become aware of this major performance gap in their own healthcare system.
Hospital governance, senior administrative leadership, and clinical/safety leadership must close their own performance gap by implementing a comprehensive approach to addressing the performance gap.
A goal date should be set to implement the plan to address the gap with measurable quality indicators.

“Some is not a number. Soon is not a time."\cite{APSS4Cite24}.

Specific budget allocations for the plan should be evaluated by governance boards and senior administrative leaders.
Clinical/safety leadership should endorse the plan and drive implementation across all providers and systems.

Practice Plan

Formally address opportunities to improve electronic detection of deteriorating patients and the early notification of the caregivers. This includes the prevention of adverse events due to respiratory depression from pain medications.
Implement systematic protocols to assess pain management protocols and unify order sets where possible.
Implement multi-modality pain strategies \cite{_NA__2012}.
Implement an effective system to accomplish continuous electronic monitoring and notification and escalation.

Continuous oxygenation and/or respiratory monitoring (not spot check monitoring) with pulse oximetry through an adhesive sensor. Pulse Oximetry with measure through motion and low perfusion technology is preferred.
Remote notification system that provides alarm notification to the care provider.
A system of alarm escalation if the primary nurse does not respond in a timely manner.
Set SpO2 alarms to reduce non-actionable alarms
Depending on the institution and patient populations within that institution, lower alarm limits may be set to be conscious of alarm fatigue. Each institution should set limits to fit their specific patient population.
Continuous ventilation monitoring (e.g. capnography or respiratory acoustic rate monitoring) for reduced respiratory rate in patients on supplemental oxygen.
Set respiration rate alarms to reduce non-actionable alarms (National Quality Forum 2010)
Depending on the institution and patient populations within that institution, lower alarm limits may be set to be conscious of alarm fatigue. Each institution should set limits to fit their specific patient population.
Continuous electronic monitoring systems should integrate multiple physiologic parameters in the form of an index to identify clinically significant changes earlier and more reliability.

Formalize transfer protocols from surgery and intensive care unit to postoperative general floor unit.
Formalize workflows for patient admits and discharges from continuous monitoring.
Rapid response team

Identify the opportunities for implementation of rapid response teams and protocol for initiating a rapid response call for postoperative respiratory depression.(Alam 2014)
Since family members are often highly sensitive to changes in a patient’s condition, it is advisable to allow families to ask the nurse to activate the rapid response system. Families should be educated regarding this option \cite{Brady_2014}.
Consider proactive rounding on high-risk patients by resource nurses with critical care training \cite{Hueckel_2006}.

Technology Plan

Suggested technologies are limited to those proven to show benefit or are the only known technologies with a particular capability. Other technology options may exist, please send information on any additional technologies, along with appropriate evidence, to info@patientsafetymovement.org.

Continuous pulse oximetry

Adhesive pulse oximetry sensor connected with pulse oximetry technology proven to measure through motion and low perfusion to avoid false alarms and detect true physiologic events, with added importance in care areas without minimal direct surveillance of patients (ie: Masimo SET® pulse oximetry, in a standalone bedside device or integrated in one of over 100 multi-parameter bedside monitors, until another technology is proven to be equivalent) \cite{Shah_2012}.

Continuous respiratory rate monitoring

Ability to accurately measure changes in respiratory rate and cessation of breathing with optimal patient tolerance and staff ease of use in order to avoid false alarms, with added importance in care areas without minimal direct surveillance of patients (e.g. Masimo rainbow® Acoustic Monitoring \cite{Mimoz_2012}, EarlySense Contact Free Monitoring System, or sidestream end-tidal carbon dioxide monitoring such as Oridion®, Masimo® or Respironics®).

Remote monitoring and notification system

Remote monitoring with direct clinician alert capability compatible with recommended pulse oximetry technology or other respiratory rate monitoring technologies (Masimo Patient SafetyNet™, EarlySense Contact Free Monitoring System or comparable multi-parameter monitoring system).
Direct clinician alert through dedicated paging systems or existing hospital mobile device notification system.

Network

Medical-grade wireless network suitable to permit reliable, continuous remote monitoring and documentation during ambulation and/or transport.
Alternatively, a wired network can be used which allows surveillance of patients while they are in bed but not while they are ambulating.

Metrics

Topic

Agency for Healthcare Research and Quality (AHRQ) Patient Safety Indicator (PSI) #11 Postoperative Respiratory Failure RateRate of patients with postoperative respiratory failure per 1,000 elective surgical discharges for patients 18 years and olderas defined by the Agency for Healthcare Quality and Research (AHRQ)

Outcome Measure Formula

Numerator: Discharges, among cases meeting the inclusion and exclusion rules for the denominator, with either:

any secondary ICD-9-CM or ICD-10-CM diagnosis code for acute respiratory failure; or
any-listed ICD-9-CM or ICD-10-PCS procedure codes for a mechanical ventilation for 96 consecutive hours or more that occurs zero or more days after the first major operating room procedure code (based on days from admission to procedure); or
any-listed ICD-9-CM or ICD-10-PCS procedure codes for a mechanical ventilation for less than 96 consecutive hours (or undetermined) that occurs two or more days after the first major operating room procedure code (based on days from admission to procedure); or
any-listed ICD-9-CM or ICD-10-PCS procedure codes for a reintubation that occurs one or more days after the first major operating room procedure code (based on days from admission to procedure)

Denominator: Elective surgical discharges, for patients ages 18 years and older, with any-listed ICD-9-CM or ICD-10-PCS procedure codes for an operating room procedure. Elective surgical discharges are defined by specific DRG or MS-DRG codes with admission type recorded as elective.Exclude cases:

with a principal ICD-9-CM or ICD-10-CM diagnosis code (or secondary diagnosis present on admission) for acute respiratory failure (see above)
where the only operating room procedure is tracheostomy
where a procedure for tracheostomy occurs before the first operating room procedure†
with any-listed ICD-9-CM or ICD-10-CM diagnosis codes for neuromuscular disorder
with any-listed ICD-9-CM or ICD-10-PCS procedure codes for laryngeal or pharyngeal, nose, mouth or pharynx surgery
with any-listed ICD-9-CM or ICD-10-PCS [if appropriate] procedure codes involving the face and any-listed ICD-9-CM or ICD-10-CM diagnosis codes for craniofacial anomalies
with any-listed ICD-9-CM or ICD-10-PCS procedure codes for esophageal resection
with any-listed ICD-9-CM or ICD-10-PCS procedure codes for lung cancer
any-listed ICD-9-CM or ICD-10-CM diagnosis codes for degenerative neurological disorder
MDC 4 (diseases/disorders of respiratory system)
MDC 5 (diseases/disorders of circulatory system)
MDC 14 (pregnancy, childbirth, and puerperium)
with missing gender, age, quarter, year, or principal diagnosis

† If day of procedure is not available in the input data file, the rate may be slightly lower than if the information was available.

* Rate is typically displayed as Patients/1000 Elective surgical discharges

Metric Recommendations

Direct Impact: All elective surgical patients

Lives Spared Harm:

Actionable Patient Safety Solutions #9A: Early Detection & Treatment of Sepsis (For High-income Countries)

Ariana Longley

and 25 collaborators

Executive Summary Checklist

In order to establish a program to improve the early detection and treatment of sepsis, the following implementation plan will require actionable steps.

Commitment from hospital governance and senior administrative leadership to support early detection and appropriate management of sepsis in their healthcare system.
Develop a team approach to implement a protocol for early sepsis identification and treatment.
Create a sepsis dashboard for your organization’s leadership.
Implement a Sepsis Rapid Response Team or incorporate early detection of sepsis into your existing medical emergency teams (e.g. rapid response teams).
Formalize processes to screen patients for signs of sepsis throughout the entire institution.
Implement an effective monitoring system to accomplish continuous monitoring and early detection, based on existing data (SIRS criteria, MEWS or any other warning system being used).
Select an EHR or leverage the existing EHR to serve as a data collection tool and repository for predicting risk of sepsis for patients. A system that provides a data collection tool and allows for continuous analysis and surveillance will be most beneficial.
Implementation of automated electronic screening and documentation of process of care based on existing data (SIRS criteria, MEWS or any other warning system being used).

Actionable Patient Safety Solutions #9B: Early Detection & Treatment of Sepsis (For Low and Middle-Income Countries)

Ariana Longley

and 13 collaborators

Executive Summary Checklist

Commitment from hospital administrators, leaders and senior clinicians to support early detection and appropriate management of sepsis in their healthcare system.
Develop a team approach to implement a protocol for early sepsis identification and treatment. Identify key stakeholders and a team leader.
What is the current "reality of sepsis care" in your organization? Create a list of data and collect data to assess processes and outcomes of care for sepsis.
Create a clear vision of where you want to be and what you would like to improve.
Be systematic in your approach to quality improvement - Plan, Do, Study and then Act.
Implement a system for improving recording of vital signs and use of early warning scores to identify severely ill patients such as patients with sepsis.
Implement a system for early detection of sepsis such as screening and response throughout the hospital or in specific areas, e.g. emergency department, maternity wards, intensive care unit, pediatrics, surgical wards.
Develop bundles and systems to improve implementation:

For sepsis, implement processes for rapid assessment and intervention at the bedside and initiate sepsis bundle (surviving sepsis campaign 3-hour element).
For septic shock, implement processes for rapid assessment, intervention, and need for higher level of care and initiate septic shock bundle (surviving sepsis campaign 6-hour elements).

For those who can acquire electronic systems:

Acquire electronic systems to facilitate data collection and screening for sepsis.
Implement an automated system for electronic screening and documentation of the process of care based on existing data. This may involve using SIRS criteria, MEWS, qSOFA, or any other warning system being used.

Implement a process for continuous monitoring of electronic systems and protocols.

Compliance, efficacy and outcome measures.
Design a workflow specific to level of alert.
Screening: SIRS/Sepsis/Septic shock workflow.
Mortality prediction: Early Warning Score e.g. Universal Vital Assessment, MEWS or qSOFA (or "Level of Risk") .

Implement case reviews when cases are not managed well or when outcomes are poor e.g. mortality, intensive care admission, prolonged stay in the hospital.

The Sepsis Improvement Gap

In May 2017, the World Health Assembly passed a resolution to improve sepsis care. Sepsis is now recognized as a global priority with significant public health impact. However, huge variation exists between high-income countries (HIC) and low and middle-income countries (LMIC) and their programmatic approaches to improving sepsis care.

This document is intended for use by healthcare administrators and clinical leaders to support sustainable improvements in the health system’s approach to the management of sepsis. It is divided into 3 sections:

What is sepsis and why is it important?
How to use a quality improvement approach to improve sepsis management?
How to use resources and tools to support sepsis improvement programs?

What is sepsis and why is it important to you?

What is sepsis?

In simple terms, patients with sepsis are patients who are seriously ill with infection and likely to die or be admitted to the intensive care setting as a result. Sepsis arises when the body’s response to infection injures its own tissues and organs. It can lead to septic shock, multiple organ failure and death, if not recognized early and managed promptly. It is a major cause of morbidity and mortality in all populations living in LMICs, including the most vulnerable such as pregnant women, neonates and young children. Sepsis can result from severe infections with bacteria, viruses, fungi or parasites; it is their common pathway to death. A person can develop sepsis in the community (such as community acquired pneumonia) or in the hospital (such as nosocomial infection). Sepsis can also develop when infections are from dangerous, emerging infectious diseases (such as viral hemorrhagic fevers).

What is burden of sepsis?

Actionable Patient Safety Solutions #2D: Ventilator-associated Pneumonia (VAP)

Ariana Longley

and 30 collaborators

Executive Summary Checklist

In order to establish a program to reduce ventilator-associated pneumonia (VAP) the following implementation plan will require these actionable steps. The following checklist was adapted from the prevention strategies recommended by the California Department of Public Health (CDPH) \cite{00001}, American Association of Critical Care Nursing \cite{adults}, the American Thoracic Society and Infectious Disease Societies of America \cite{2005}.

Commitment from hospital leadership to support a program to eliminate VAP.
Implement evidence-based guidelines to prevent the occurrence of VAP.

Prevent aspiration of secretions
Maintain elevation of head of bed (HOB) (30-45 degrees)
Avoid gastric over-distention
Avoid unplanned extubation and re-intubation
Use cuffed endotracheal tube with subglottic suctioning
Maintain the endotracheal tube cuff pressure at greater than 20 cmH20
Encourage early mobilization of patients with physical/occupational therapy
Ensure that patient is conscious and responsive prior to extubation.
Reduce duration of ventilation
Conduct “ sedation vacations”
Assess readiness to wean from ventilator daily
Conduct spontaneous breathing trials
Reduce colonization of aero-digestive tract
Use non-invasive ventilation methods when possible (i.e. CPAP, BiPap)
Use oro-tracheal over naso-tracheal intubation
Use cuffed Endotracheal Tube (ETT) with subglottic suctioning
Perform regular oral care with an antiseptic agent
Reduce opportunities to introduce pathogens into the airway
Prevent exposure to contaminated equipment
Use sterile water to rinse reusable respiratory equipment
Remove condensation from ventilator circuits
Change ventilator circuit only when malfunctioning or visibly soiled
Store and disinfect respiratory equipment effectively
Measure adherence to VAP prevention practices and consider monitoring compliance
Hand Hygiene
Daily sedation vacation/interruption and assessment of readiness to wean
Regular antiseptic oral care
Semi-recumbent position of all eligible patients
Monitor ventilated patients for: positive cultures, temperature chart/log, pharmacy reports of antimicrobial use, and change in respiratory secretions
When complications exist, raise them on top of the patient’s EHR problem list.

Develop an education plan for attendings, residents and nurses to cover key curriculum pertaining to the prevention of VAP.
Encourage continuous process improvement through the implementation of quality process measures and metrics and a monthly display through a dashboard

The Performance Gap

Ventilator-associated pneumonia (VAP) is an infection that appears in the lungs when a patient is mechanically ventilated. Mechanically ventilated hospital patients are typically critically ill and treated in an intensive care unit (ICU). The infection develops after 48 hours or more of mechanical ventilation and is caused when bacteria reaches the lower respiratory tract via the endotracheal tube or tracheostomy; in addition, when airways are not properly maintained intubation may allow oral and gastric secretions to enter the lower airways \cite{00002a}.

VAP is the leading cause of death associated with healthcare-associated infections (HAIs) \cite{00003}. In the US, a multi-state prevalence survey estimated the incidence of VAP in the US at 49,900 cases annually \cite{2014}. As many as 28% of all patients who receive mechanical ventilation in the hospital will develop VAP and the incidence increases with the duration of mechanical ventilation. The crude mortality rate for VAP is between 20% and 60%; and incidence ranges from 4% to 48% \cite{9735080}\cite{10194173}. Depending on the type of pneumonia the mortality rate may vary; Pseudomonas and Acinetobacter are associated with higher mortality rates than other strains of bacteria \cite{Fagon_1996}. It is believed that when antibiotic therapy is delayed or improperly dosed, mortality also increases. These factors are largely preventable.

Patients who acquire VAP have significantly longer durations of mechanical ventilation, length of ICU stay as well as hospital stay \cite{Rello_2002}. In addition, the development of VAP is associated with significant increase in hospital costs and poor economic outcomes. VAP is associated with greater than $40,000 in mean hospital charges per patient.

It is estimated that the use of process change and technology to reduce VAP can save up to $1.5 billion per year while significantly improving quality and safety \cite{00006}. Closing the performance gap will require hospitals and healthcare systems to commit to action in the form of specific leadership, practice, and technology plans, examples of which are delineated below for utilization or reference. This is provided to assist hospitals in prioritizing their efforts at designing and implementing evidence-based bundles for VAP reduction.

Leadership Plan

Hospital governance and senior administrative leadership must champion efforts in raising awareness to prevent and manage VAP infections safely.
Healthcare leadership should support the design and implementation of an antimicrobial stewardship program.
Senior leadership will need to integrate surveillance and metrics to ensure prevention measures are being followed.
Leadership commitment and action are required at all levels for successful process improvement.

Actionable Patient Safety Solutions #3E: Standardizing and Safeguarding Medication Administration

Jacob Lopez

and 5 collaborators

Executive Summary Checklist

The ability for healthcare providers to safely and rapidly deliver acute, lifesaving medications to themselves and their families is a reasonable and universal expectation of every patient, yet an incredible challenge to healthcare providers. In order to delineate and disseminate the minimal viable solutions needed to standardize and safeguard acute medication delivery for all patients:

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