Global Patient Safety 2017: A Call To Action
Global Patient Safety 2017:A Call to ActionVictor J Dzau, MDPresident, National Academy of MedicineSecond Global Ministerial Summit on Patient SafetyMarch 30, 2017
outline Who we areEarly IOM work on qualityMajor milestones in global patient safety movementWhere we are nowCore pillars of a patient safety strategycurrent issues in patient safetyThe next horizonMegatrends/threats to patient safetyImportance of global collaboration to move forward
U.S. National Academy of Sciences (1863)“The academy shall, whenever called upon by any department of the government,investigate, examine and report upon any subject of science or art, ”1970 Institute of Medicine founded to advise & improve health of people everywhere.The New York Times describes the IOM as “the most esteemed and authoritative adviseron issues of health and medicine, and its reports can transform medical thinking aroundthe world.”July 1, 2015 IOM is reconstituted as the National Academy of Medicine
The IOM Quality SeriesFoundational Reports19992001
To Err is Human: Building a Safer Health System Medical errors can be defined as the failure of a plannedaction to be completed as intended or the use of a wrongplan to achieve an aim The majority of errors are caused by faulty systems,processes, and conditions that lead people to makemistakes or fail to prevent them 44,000 - 98,000 people die in US hospitals each year asa result of preventable medical errors Errors cost 17 billion – 29 billion per year in hospitalsin the USHowever, more recent data indicate that these numbersmay be substantially higher (James, 2013, JPS)
Crossing the Quality Chasm: A New Health Systemfor the 21st Century (2001) Described broaderquality issues anddefines six aims—careshould be safe, effective, patient-centered, timely, efficient and equitable2001
Crossing the Quality Chasm:Redesign a New Health System for the 21st Century
IOM Work on Quality
Patient Safety Movement
The “To Err is Human” report and thepatient safety literature(Stelfox et al, 2006)Editorials, letters, reviews,guidelines, and other itemsStelfox, 2006, Qual SafHealth CareResearch awards
Patient Quality & Safety Movement:United States“To ErrIs Human”IOM ReportExecutiveMemo fromPresidentClintonAHRQIHI’s100K livesCampaignPatient Safetyand QualityImprovementAct of 2005JCAHONationalPatient SafetyGoalsNationalImplementationof CUSPHHS sets goalsand timeline fortying payment tovalueACATeamSTEPPS 1999 199920012003200420052005200820102015
Patient Quality & Safety Movement:WorldwideNPSF’s launchesPatient SafetyAwareness WeekAnOrganizationwith a MemoryNHS formsNationalPatient SafetyAgencyWHO launchesWorld Alliance forPatient Safety andForward ProgrammePeter Pronovost’sMedical SafetyChecklistWHO SafeSurgeryChecklistCanadian PatientSafety InstituteEstablished20032000 20012002200420062008WHO’s SafeChildbirthChecklistWHO PatientSafetyCurriculumGuide20112015
Where are we now? Even countries that are pioneers in patient safety,such as the US and UK, still struggle, e.g.,– Number of preventable hospital associated deathsestimated to be over 200,000 each year in the US– European data consistently show that medical errors andhealth-care related adverse events occur in 8% - 12% ofhospitalizations National Patient Safety Foundation Survey (2015):“Although the current evidence regarding overallimprovement in patient safety is mixed the majorityof the panel felt that overall health care is safer thanin the past.”
Beyond Mortality - The Burden ofMedical Error: United States 1 in 10 patients develops an adverse event duringhospitalization (AHRQ Efforts, 2014) More than 700,000 outpatients are treated in the emergencydepartment every year for an adverse event caused by amedication– 120,000 of these patients require hospitalization (Budnitz et al. 2006) One-third of Medicare beneficiaries in skilled nursing facilitiesexperienced an adverse event; half of these events weredeemed preventable (OIG 2014)
Principles of Safe Patient Care The Importance of Culture in achieving Safe PatientCare Achieving Effective Communication and Teamwork Patient Centered Culture – engagement & empowerment Moving from Blame to Accountability Managing Behavior (www.justculture.org) Disclosing Unanticipated Outcomes Performance Measurement & Measuring our Progress Measuring Safety Culture: Safety Attitude Questionaire
Measuring Safety Culture: SAQTwo overall domains of interest:– Teamwork Climate (interaction norms: 60% needs action)– Safety Climate (pt safety norms: 60% needs action)Three supporting domains:– Stress Recognition (threat awareness/believabilitybarometer: 40% needs action)– Resilience (pace/intensity barometer: 60% needsaction)– Work Life Balance (self care norms: descriptiveonly/no threshold)Page 16
Managing ErrorAt-RiskBehaviorProduct of our currentsystem designUnintentional Risk-TakingIntentional Risk-TakingManage through changes in:Manage through:Manage through: e Removing incentives forAt-Risk Behaviors Creating incentives forhealthy behaviors Increasing situationalawarenessCoachNote that this is a continuum Remedial action Disciplinary actionPunish
Investing in patient safety wisely requires goodknowledge about the strength and flaws of ournational systems, our hospitals, our practices– Ingo Härtel (2017)
OECD Health System PerformanceAssessment Framework
Patient Safety Global Action Summit9-10 March 2016, London, UK Political commitment and leadership, Policies that encourage and enable patientsafety improvement, Paradigm shift: providing a safe space forpeople to report, Performance measurement: benchmarking,developing indicators and data systems, Patient safety movement: a call for urgent actionby governments.
Current & Emerging Issues in Patient Safety(Expert Workshops) Economy and Efficiency of Patient Safety Prevention and Control of Infectious Diseases Global Patient Safety – Perspectives fromLMICs Patient Safety and mHealth, Big Data, andHandheld Devices Increased Safety of Diagnostics and Treatment –Checklists and Other Tools Safety of Medication Therapy
Economy and Efficiency of PatientSafety
Key Findings on the Costs of Failure(OECD, 2017) Patient harm is the 14th leading cause of the global disease burden. Most research on the cost of patient harm has focused on the acute caresetting in the developed world. The financial impact of safety failure is considerable. Approximately 15% oftotal hospital activity and expenditure is a direct result of adverse events.The most burdensome adverse event types include venousthromboembolism, pressure ulcers, and infections Less is known about harm in primary and ambulatory care. Researchindicates that wrong or delayed diagnosis is a considerable problem. The flow-on and indirect costs of harm include loss of productivity anddiminished trust in the healthcare system. In 2008, the economic cost ofmedical error in the US was estimated to be almost USD 1 trillion. The costs of prevention are dwarfed by the cost of failure.– For example improving patient safety in US Medicare hospitals is estimated to have savedUSD 28 Billion between 2010 and 2015.
National efforts to reduce harm and improvesafety can deliver considerable savings
Prevention and Control of Infectious Diseases Burden of health care-associated infections in Europe andworldwide WHO core components for infection prevention and control– Implementation in LMICs How to measure the degree of implementation? Establishment ofsurveillance systems, external assessments vs self-assessment The special problem of sepsis: how to prevent and recognize it Best Practices–––––10-year sustained IPC national programme in ChileThe development of a European surveillance system for HAINational monitoring IPC indicators in LiberiaDuplication of hand rub consumption in Germany within 10 yearsThe sepsis campaign in England
Antimicrobial Resistance (AMR)A continued rise inresistance by 2050 wouldlead to 10 million peopledying every year and areduction of 2% to 3.5%in Gross Domestic Product(GDP). It would cost theworld up to 100 trillion USD.O’Neill, 2016
Combating AMR Reduce demand through– Global public awareness campaign– Improve hygiene and prevent the spread of infections– Reduce unnecessary use of antimicrobials in agricultureand their dissemination into the environment– Improve global surveillance of drug resistance andantimicrobial consumption in humans and animals– Promote new, rapid, diagnostics to cut unnecessary use ofantibiotics– Promote development and use of vaccines andalternatives Increase the number of effective antimicrobial drugsO’Neill, 2016
Diagnostic Error A conservative estimate found that 5 % U.S. adults seekingoutpatient care each year experience a diagnostic error. Postmortem examination research has shown that diagnosticerrors contribute to approximately 10 percent of patient deaths. Medical record reviews suggest that diagnostic errors accountfor 6-17 % of hospital adverse events. In a review of 25 years of malpractice claims, diagnostic errorswere Leading type (28.6%) More outpatient than inpatient (68.8% vs 31.2%) Responsible for payments of US 38.8 billion (inflationadjusted)
The IOM Quality Series: Improving DiagnosisThe failure to:(a)establish an accurate and timelyexplanation of the patient’s healthproblem(s); or(b) communicate that explanationto the patient“ It is likely that most of us willexperience at least one diagnostic errorin our lifetime, sometimes withdevastating consequences.”2015
INSTITUTE OF MEDICINE
INSTITUTE OF MEDICINE
Diagnostic Process:Learning Healthcare System
8 Goals to Improve Diagnosis and Reduce Diagnostic ErrorGOAL 1more effective teamwork in the diagnostic processGOAL 2education and training in the diagnostic processGOAL 3health information technologies support patients and care professionalsGOAL 4identify, learn from, and reduce diagnostic errorsGOAL 5 work system and cultureGOAL 6 reporting environment and medical liability system that facilitateslearning from diagnostic errors and near missesGOAL 7 payment and care delivery environment that supports the diagnosticprocessGOAL 8 dedicated funding for research
Patient Safety and mHealth
mHealth "Mobile Health (mHealth) is an area of electronic health(eHealth) and it is the provision of health services andinformation via mobile technologies such as mobile phonesand Personal Digital Assistants (PDAs).“ (WHO) BCC Research, which studies technology-based markets,forecasts that global revenues for m-health will reach 21.5billion in 2018, with Europe the largest m-health market mHealth products hold the promise of improving healthoutcomes, reducing medical errors, avoiding costlyinterventions, and broadening access to care However, mHealth risks are not well understood
Range of mHealth Apps
mHealth Risks Privacy concerns Poor quality patient data Quality of clinical decision, e.g.,– Incorrect diagnosis– Incorrect care advice Inaccurate or out of date content
mHealth Risks
mHealth Regulation: USCortez et al, 2014
mHealth Regulation: US FDA Risk Based Approach Most consumer devices free from regulatory requirements– unless the application is working with an accessory which is a medicaldevice, makes specific medical claims that the app could treat or cure adisease, or stores or analyzed patient-specific medical data FDA can review mHealth devices through the FDCA’s devicereview process– Class I: Generally low risk and subject to minimal regulatory oversight.– Class II: Moderate-risk devices subject to both general controls and"special controls“ established for the type of device. Many are subject topremarket notification (the "510(k)" pathway) which requires FDA toreview a device.– Class III: The riskiest devices, almost always must be approved by FDAbefore they are allowed on the market, and typically rely on evidenceobtained through clinical testing.
mHealth Regulation: Europe European Union: guidelines with little clarity– While standalone software can be deemed a medicaldevice under the Medical Device Directive, the definitionsare not explicit and therefore are open to interpretation. Most countries do not have mHealth specificlegislation implemented– Countries/regions that do have legislative and governanceframework covering mHealth are UK, Catalonia andFinland. UK has set up an Information Governance toolkit, acode of practice for application developers. Catalonia alsohas an accreditation application model in place, andsimilarly, Finland has set certification criteria for mHealthapplications.Dell, 2014; Report on nationalmHealth strategies, 2016
mHealth Regulation: Germany German Federal Institute for Drugs and MedicalDevices has published guidance fordifferentiation between lifestyle applications andmedical devices, and the subsequent riskclassification a number of questions regarding the regulatoryrequirements for health apps remain– In practice, there is legal uncertainty regarding whatapp classifies as a medical device
mHealth Regulation: GermanyPlan to develop a national action plan for mHealth: an independent and in-depth study of the statusquo, opportunities and risks of mHealth a structured dialogue with all stakeholders and an activity plan to be set up (coveringdevelopment of guidelines; improving marketaccess and regulatory environment; and analysesof the use of mHealth applications).
#Risk AssessmentExample App FunctionalityMedical AppRegulation/RiskAssessment ModelAApps are predominantly lowrisk and pose minimal risk topatients if misused.BMI Calculators, patienteducation, accessing EHRs,access guidelines , otherlearning materialsClinician Self-AssessmentBApps may cause harm if usedinappropriately or withoutadequate training.Interprofessional consultationand referral, entering treatmentrequestsSelf-certification model, peerreviewCApps pose significant risk topatients due to either inherentcomplexity, functionality orpotential for harm if misusedDiagnostic support apps,specialist apps,DApps pose significant risk topatients due to combination ofinherent complexity, functionalityand potential for major harm ifmisused.Lewis and Wyatt, 2014patient decision appsClinical decision support tools,control devices, closed loopappsBest practice guidelines, formalassessments by local healthorganizationFormal assessment andregulation by professionaland/or government body, e.g.,FDA
Global Patient Safety – Perspectivesfrom LMICs
Universal Health Care: Need to Assure Quality Unsafe care causes 43 millioninjuries a year and the loss of23 million disability-adjustedlife years (DALYs), about twothirds of them in low- andmiddle-income countries (Jhaet al., 2013) The probability of a patientreceiving the correct diagnosisis, depending on other factors,in the range of 30 to 50percent The probability of a patientreceiving non-harmfultreatment found a likelihood ofabout 45 percent
NASEM Consensus Study: Improving Qualityof Care in Low- and Middle-Income Countries Determine the scope of the problem in LMICs Evaluate the evidence base related to safety,effectiveness, patient – centeredness, timeliness,efficiency, and equity Assess current measurements of health-care qualityand develop new measurements as needed Create decision support frameworks for systemicinterventions and changes in delivery and patient careprocesses to improve quality Identify where costs can be reduced by improvingquality Assess the impact of quality on UHC- outcomes andeconomics
Summary Patient safety has generated a lot of momentumover the last 20 years Need for a systems approach and local solutions toimprove patient safety Economic constraints necessitate a value basedapproach– Patient safety efforts can generate significant cost savings Current and emerging issues of importance: healthcare associated infections, diagnostic error, mHealth Extending the quality agenda to LMICs
Advancing Patient Safety in 2017:Call to Action Continued emphasis on a systemsapproach to improving patient safety Assess performance - understand thescale of the patient safety challenges, bothnationally and internationally Mutual learning – share best practices Sustained commitment from policy makers WHO Annual Patient Safety Day
The Journey Continues
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may be substantially higher (James, 2013, JPS) Crossing the Quality Chasm: A New Health System . National Patient Safety Goals IHI’s 100K lives Campaign 2004 2005 Patient Safety . Patient Quality & Safety Movement: Worldwide 2000 An Organization with a Memory NHS forms National Patient Safety Agency 2001 NPSF’s launches Patient Safety .
Cape Fear Valley has a Performance Improvement (PI)/ Patient Safety Plan. The plan describes the structures and functions of the Patient Safety Program and defines the responsibilities necessary to assure that the Patient Safety Program is effective. It can be found on the InfoWeb under: - 2012-2013 Performance Improvement/Patient Safety Plan
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This Patient Safety Primer discusses the role of organizational leadership in improving patient safety. The crucial roles that frontline and midlevel providers play in improving safety are discussed in the related Safety Culture and High Reliability Patient Safety Primers. Institute for Healthcare Improvement Web site, Publications page.
Patient Safety Primer: Disruptive and Unprofessional Behavior Patient Safety Primer: Medication Errors Patient Safety Primer: Missed Nursing Care . anesthesia/sedation, prior to introduction of the endoscope, and prior to the patient leaving the procedure room. The che
National Patient Safety Agency (NPSA) nursing lead Woodward says it is essential to encourage a culture where health professionals can be open about patient safety and errors. (Blakemore 2009,15.) According to the World Health Organization 2011 report on patient safety, health care-associated infections (HCAIs) are those that the patient gets .
Integrate Patient Safety Concerns in the Design Process Abstract Purpose The project aimed to develop consensus around important patient safety issues to be considered during various stages in the healthcare design process and to identify key activities, methodologies, and tools for improving facility design in terms of patient safety. Scope
Color code the medications (Patient Safety Network, 2021). Simplify instructions for all high-risk medications by using models, pictures or videos (Patient Safety Network, 2019). Standardized protocol and dual verification (Patient Safety Network, 2021). Confirm patient comprehension (Patient Safety Network, 2021). 17 LOW-TECH .
Cambridge Global English Stage 8 Workbook 3 Rewrite the sentences using although. 1 I speak English quite well, but I fi nd English spelling hard. Although I speak English quite well, I nd English spelling hard. 2 The islands of Trinidad and Tobago are very close to Venezuela, but English is spoken there, not Spanish. 3 Welsh settlers fi rst went to Patagonia in 1865, but Welsh is still .
