Jacob Lopez

and 13 more

Executive Summary ChecklistSuccessful implementation of NG tube safe practices includes a commitment from hospital governance and senior administrative leadership to Identify and maintain awareness of performance gaps within their organization.Institutional procedures guiding NGT insertion and placement verification should be evidence-based and should provide guidance to staff on when a patient is considered high risk for misplacementAll NGTs should be radio-opaque throughout their length with external centimeter length markings to be used to detect post-insertion tube movement.All staff who place NGTs should be specifically trained in this procedureAccurate measurement prior to insertion should utilize the NEMU (Nose→Earlobe→Mid-Umbilicus)pH of gastric aspirate should be used to confirm NG placement prior to initial use with pH in desired range of 1.0 to 5.0.  If unable to obtain a gastric aspirate within the required pH range, confirm NG placement with a radiograph.All staff who read radiographs should be specifically trained in reading the radiograph using the following four criteria:  Does the tube path follow the esophagus/avoid contours of the bronchi?Does the tube clearly bisect the carina or the bronchi?Does the tube cross the diaphragm in the midline?Is the tip clearly visible below the left hemi-diaphragm?Confirmation of NG tube should be documented in the EMR and method of confirmation (ph or radiograph).  Tubes should be secured to the patient after confirmation in such a way that the centimeter mark is visible at the nare.  This mark should be documented in the medical record and used as a point of reference for other caregivers to gauge movement of the tube.Observe for signs of respiratory distress or gagging/vomiting and remove tube if these signs are present as NG tube may have been dislodged into the airway or lungs.A mandatory reporting system should be developed to track nasogastric feeding tube misplacements as a percentage of all tubes placed. The Performance GapNasogastric tubes (NGTs) are a commonly used intervention in clinical practice for decompression or for administration of enteral nutrition, fluids and medications.  In a neonatal and pediatric one day prevalence study of 63 institutions, 24% of hospitalized infants and children required an orgastric (OG), nasogastric (NG), or transpyloric tube \cite{Lyman_2015}.  Of those patients, 61% were located in a neonatal intensive care unit (NICU). A National Patient Safety Alert (NPSA) issued by the National Health Service (NHS) documented over 3 million NG or OG tubes were used from 2011-2016 in the United Kingdom (UK) \cite{parker2016}. These tubes are inserted using blind placement technique, so called because the person doing the procedure cannot discern where the tube is going in the body as it is being advanced.  As a consequence, complications can occur if the NG or OG is misplaced into the esophagus, duodenum or pulmonary tree.  Serious patient harm and deaths have occurred when tube misplacement is not detected prior to use.Studies of adult patients report NGT misplacement with serious harm to patients in 1.3 to 3.2% of tubes placed\cite{Gilbertson2011,Bourgault2009}. A study of neonates documented an incidence of 59% NGT misplacements with the majority of tubes being in the esophagus\cite{October2009}.  The Pennsylvania Patient Safety Authority documented 44 NGT misplacements into the lung from 2011-2013\cite{Powers2013}. Of these events, 24 were classified as serious patient harm.  Case reports in the literature describe such injuries as pneumothorax, enteral formula administration into the lung, esophageal perforation, and even death \cite{Gilbertson_2011,Bourgault_2009}. Failure to detect misplaced NGTs are attributed to: use of non-evidence based methods to confirm initial placement (auscultation or aspiration), failure to recognize when an NGT has changed position, failure to properly read an abdominal radiograph, failure to accurately interpret an electromagnetic device screen \cite{October_2009,Powers_2013}.
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Ariana Longley

and 32 more

Executive Summary ChecklistMedication errors (wrong drug, wrong dose, wrong patient or route of administration and wrong documentation) are a major cause of inpatient morbidity and mortality.  An effective program to reduce medication errors will require an implementation plan to complete the following actionable steps:Hospital leadership must understand the medication safety gaps in their own system, and be committed to a comprehensive approach to close those gaps.Create a multidisciplinary team, including physicians, nurses, pharmacists, and information technology personnel to lead the project.Implement systematic protocols for medication administration, featuring checklists for writing and filling prescriptions, drug administration, and during patient transitions of care, as well as other quality assurance tools.  These tools will include:Installing the latest safety technology to prevent medication errors, such as the BD Intelliport™Medication Management System and First Databank FDB MedKnowledge™ system or other drug dosing solutions for individual or categories of medications such as Monarch Medical Technologies solution for calculating IV & SubQ insulin doses.Use barcoding for drug identification in the medication administration process.Check patient’s allergy profile before prescribing medication.Ensure appropriate training and safe operation of automated infusion technologies.Distinguish “look-alike, sound-alike” medications by labeling, package design, and storage.Implement a system for patient follow-up to ensure medication adherence.Implement technology that standardizes Computerized Physician Order Entry (CPOE), reporting systems and quality assurance reports to audit compliance with safe drug administration practices. [MG integration in EHR]Clinical Decision Support Systems (CDSS) should be implemented if the institution or system has the infrastructure in place to add CDSS for specific medications or groups of medications, as an extra layer of safety \cite{28816851}.Practice the Six Patient Rights on Medications: right patient, right drug, right dose, right route, right time of administration and right documentation of medication administration.  All care providers should use this simple checklist.Provide education of all hospital personnel in the principles above.  Monitor the effectiveness of this education at regular intervals.Review monitoring/reporting results at medical staff meetings and educational sessions as a part of Continuous Quality Improvement (CQI).Regulatory Vendor Background checks.  There are over 100 different classifications for FDA manufacturing with each registration allowed a different type of labeling, packaging, verification and delivery.  If the drug is not delivered correctly in the first place to the hospital or physician practice, then the concept of Right Drug cannot be confirmed.
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Ariana Longley

and 7 more

Executive Summary ChecklistInappropriate use of antimicrobial drugs (antibiotics, etc.) is a significant cause of patient morbidity and mortality.  This risk can be greatly reduced by an Antimicrobial Stewardship Program (ASP), which requires an implementation plan that includes the following actionable steps:Commitment from institutional leadership (administration, medicine, pharmacy, nursing, microbiology, and technology) to develop and support an Antimicrobial Stewardship Program.Create a multidisciplinary Antimicrobial Stewardship Committee that includes infection prevention, infectious disease professionals from Medicine and Pharmacy, Microbiology Laboratory, Nursing, and Information Technology. This group will ensure the:accountability of ASP chair or co-chairs.development of protocols to support ASP initiatives and interventions.personnel training and support.necessary infrastructure for measuring antimicrobial use and outcomes.monitoring of microbial resistance and its effect on disease patterns.development of clear goals for the ASP, including timelines and metrics.delivery of regular updates to the institutional antibiogram and compliance with Clinical Laboratory Standards Institute (CLSI) guidelines.Implement Computerized Physician Order Entry (CPOE) with Clinical Decision Support (CDS) and computer-based surveillance software to provide real-time data at the point of care for ASP initiatives.Develop mechanisms to educate clinicians regarding ASP initiatives and progress.  Identify and educate clinicians who exhibit outlying prescribing patterns.  Monitor progress and include the results in staff educational sessions.All antimicrobial orders are reviewed by a hospital pharmacistThe Performance GapIn 2014 the CDC recommended that all acute care hospitals implement Antibiotic Stewardship Programs and in September 2014 California Governor Jerry Brown approved SB 1311 that required all general acute care hospitals in California to establish a physician supervised multidisciplinary Antimicrobial Stewardship committee by July 1, 2015. As of January 2017, the Joint Commissions' new Medication Management Standard on Antimicrobial Stewardship went into effect, requiring hospitals and critical access hospitals to have an antimicrobial stewardship program in place. Additionally, the Centers for Medicare and Medicaid Services will require facilities participating in Medicare and Medicaid to have formal Antimicrobial Stewardship Programs in place. The overall objectives of the Antimicrobial Stewardship Program (ASP) are to identify and reduce risks of developing, acquiring, and transmitting infections; reduce healthcare costs and toxicities associated with antimicrobials and inappropriate therapy; and, most importantly, improve patient outcomes (e.g., reduced antimicrobial/antifungal/antiviral resistance rates, reduced C. difficile rates, and reduced hospital LOS). More importantly, an effective ASP committee or team is comprised of an ID-trained physician, pharmacist (preferably ID-trained), infection control personnel, information technology personnel, quality improvement personnel, nursing, and microbiology. With leadership commitment and accountability being key requirements of a successful ASP.Inappropriate use of antimicrobials can have unintended consequences on both the pathogen and patient. From the perspective of the pathogen, resistance may be acquired and spread within the healthcare system and into the community. From the patient perspective, adverse reactions, super-infections, selection of resistant pathogens, and poor clinical outcomes may occur. Hence, optimized and judicial use of antimicrobials is a critical component of patient safety. Any institution implementing an ASP must be able to measure key variables: 1) antimicrobial use [to assess whether interventions lead to changes in use], 2) resistance patterns among microorganisms, and 3) outcomes associated with changes in antibiotic use. For instance, metrics that are used to determine the impact of the ASP is by calculating the defined daily doses (DDDs) or days of therapy (DOT) of antibiotics per 1000 patient days (see under "Pharmacy Driven Interventions for ASPs" section). The cost per quality adjusted life-year (QALY) could also be used as another metric to measure the cost-effectiveness of the program in preventing specific infections (e.g., bloodstream infections).While typically not thought of as a component of patient safety, it should be apparent that one of the key components of the ASP is the prevention of adverse drug events by decreasing the indiscriminate use of antibiotics. It should be realized that antimicrobial therapeutics are the only medications where use in one patient can affect the efficacy of that therapeutic in another patient. Additionally, the common notion that antimicrobials are benign medications is false. According to a number of studies, approximately 25% of adverse drug events arise from antimicrobial use \cite{Lesar_1997a}. Antimicrobials in one study were responsible for 19% of emergency department visits (2004-2006), in which the majority were allergic reactions. Based on this data, the study found that risks for adverse events from antimicrobial therapy were three times higher than those reported for aspirin, phenytoin, and clopidogrel \cite{Shehab_2008}. Another critical adverse outcomes associated with the use of antibiotics is Clostridium difficile colitis, often a complication associated with broad spectrum antibiotic use, but has also been reported to occur with almost any type of antibiotic. This type of infection carries an increased risk of readmission, as well as an increased risk for mortality. Hence, judicial and prudent use of antimicrobial therapy may prevent resistance, adverse drug events, and improve patient safety.Pharmacy Driven Interventions for ASPs Protocols for changes from intravenous to oral antibiotic therapy in appropriate situations.Rationale: Decrease cost, decrease hospital stay, and reduce line infections.Clinical Stability Criteria for IV to PO:AfebrileStable heart rateStable respiratory rateSystolic blood pressure >90mm HgO2 saturation >90% (O2 partial pressure >60 mm Hg)Functional GINormal mental statusDosage adjustments in cases of organ dysfunction.Rationale: Avoid toxicities.Dose optimization (pharmacokinetics/pharmacodynamics) to optimize the treatment of organisms with reduced susceptibility.Rationale: Avoid toxicities, optimize PK/PD, improve patient outcomes.Automatic alerts in situations where therapy might be unnecessarily duplicative.Rationale: Avoid toxicities and decrease costs.Time-sensitive automatic stop orders for specified antibiotic prescriptions.Rationale: Decrease cost and unnecessary antimicrobial therapy, and decrease development of resistance.Initiation of necessary treatment for patients who should be receiving antibiotics.Rationale: With no empiric or directed therapy against infecting or suspected organisms, the delay in time to an active antibiotic against the pathogen increases mortality.Antimicrobial use and efficacy analysisRationale: Need to determine the patient days for the hospital ward being analyzed for the time period of the data. The calculation is: (DDDs / patient days) * 1000. Recent guidelines from the Infectious Disease Society of America, recommend the use of days of therapy (DOT) per 1000 patient days over DDD, with DDD being an alternative at institutions that cannot collect DOT data.Development of Institution Specific Antimicrobial Stewardship Guidelines.Rationale: Source specific treatment pathways for infections should be developed based on antimicrobial resistance patterns at the institution and should align with ASP initiatives. Institutional treatment pathways will provide physicians a resource that is based on institutional data and provide guideline-concordant best practices. Utilization of clinical decision support can streamline this process.Microbiology Laboratory ContributionProviding at least yearly antibiograms (if possible twice a year). Antibiogram reporting should be location specific (e.g., ICU, general wards, or pediatric areas).Incorporate rapid diagnostics such as multiplex PCR and Matrix Assisted Laser desorption/ionization --time of flight (MALDI-TOF).Rapid diagnostics have been demonstrated to decrease the time to appropriate antibiotics and decrease the time on unnecessary antimicrobial therapy.Incorporate Pro-calcitonin level measurement in the laboratory to aid in antibiotic initiation and discontinuation.During bacterial infection, Pro-calcitonin is produced in large quantities by body tissues. Strong evidence supports its use in antibiotic management of infections, particularly, pneumonia or other lower respiratory tract infections, and has been demonstrated to significantly decrease unnecessary antibiotic use and shorten duration of therapy.Automatic testing and reporting of tigecycline and colistin or newer agents if formulary (ceftazidime/avibactam, meropenem/vaborbactam) for Carbapenem Resistant Enterobacteriaceae (CRE) isolates.As carbapenem resistance is increasingly reported, it is critical that alternative agent susceptibilities be made available. These alternative agents include tigecycline and colistin. While breakpoints for susceptibility are not available by CLSI, FDA breakpoints are available and should be used for interpretation.Reporting of minocycline susceptibility for Acinetobacter isolates.Minocycline susceptibility remains high in most institutions against multi-drug resistant Acinetobacter spp, hence this should be taken advantage of as its resistance patterns allow.Selective reporting of susceptibilities of antimicrobials.Selective reporting is a process of withholding susceptibility results from selected categories of antibiotics that may have deleterious effects on the hospital antibiogram/resistance rates, or financial cost that do not have a therapeutic advantage over other commonly used antimicrobial agents. For example, if an E. coli strain is isolated from a bloodstream infection and is not susceptible to a 1st generation cephalosporin but is susceptible to cefotaxime, other broader agents such as cefepime, meropenem, or ceftaroline can be withheld and available upon the request of the physician.Leadership PlanCommitment from the hospital leadership is required for the successful implementation and progress of any clinical program, including the ASPs. Commitment and support of ASPs should not only come from the ASP committee or infectious diseases physicians, but also from the senior administration. Formal statements made at the administrative level in support of the program implementation and progression should be clear, in this way practitioners at the hospital will know and understand the importance of the ASP's presence and goals. Some approaches that hospital/facility leadership should include in support of the ASP are \cite{Dellit_2007a}:Financial supportFormal statements supporting the ASP and optimal use of antimicrobials within the hospitalProtected/acknowledged time for personnel from various departments to participate in the ASP.Provide training and support to personnelProvision of necessary infrastructure for tracking and measuring antimicrobial use and outcomes.Practice PlanEach hospital should create a multidisciplinary team that includes an ID physician, ID-trained or clinical pharmacist, microbiologist, infection control, and information technologists.(Prevention 2015) Depending on the size, type, and resources available to the hospital different strategies can be employed.In a large academic hospital it may be possible to form an antimicrobial stewardship committee and implement either a restrictive ASP or prospective audit with feedback. In a restrictive program, select antimicrobials are placed on formulary restriction for use in only select indications. Dispensing of a restricted agent would require approval by designated personnel, usually an ID physician, ID fellow, or clinical pharmacist. The advantages of this program are:(a) the direct oversight in the use of targeted antimicrobials,(b) reduction of pathogen resistance within the hospital and communities,(c) reduced hospital LOS, and(d) reduced risks of antimicrobial-related side effects and drug-drug interactions.The disadvantages may include:(a) the requirement of personnel availability around-the-clock,(b) physicians may perceive this as a loss of autonomy, and(c) review of appropriateness only occurs with targeted/restricted agent, but not for non-restricted agents which can also lead to problems \cite{Dellit_2007a,Goff_2012}.An alternative to the restrictive program is a prospective audit with feedback program. In this program, a retrospective (hours to days) review of antimicrobial orders takes place for targeted and in some institutions non -targeted antimicrobials for appropriateness. It is also common to find programs that use a hybrid approach in which audit and feedback are employed along with a restricted formulary. Advantages of the prospective audit with feedback are the avoidance of loss of autonomy and the opportunity to educate individuals rather than only restrict utilization. A disadvantage is compliance is often voluntary \cite{Dellit_2007a}.Implementation of the above two strategies require personnel dedicated to the ASP. In most academic and medium-to-large community hospitals, formation of an ASP with either of these strategies would be possible. On the other hand, in smaller hospitals where dedicated personnel may not be available, some of the pharmacy driven interventions mentioned previously can be implemented, as they require less resources and effort. These have been referred to as "low hanging fruit" interventions as they are the simplest to implement and yet have been shown to have a positive impact \cite{Goff_2012}. Such interventions include intravenous-to-oral conversions, therapeutic substitutions, batching of intravenous antimicrobials, monitoring and discontinuing preoperative antibiotic prophylaxis.The Centers for Disease Control and Prevention has provided recommendations on core elements that should be implemented for hospital ASPs. These include:Commitment from institutional leadership (technology, personnel, finance)Accountability of ASP chair or co-chairsA clinician with drug expertise in antimicrobials [e.g., clinical pharmacist (Infectious Disease trained)]Actionable program components (e.g., prospective audit, automatic discontinuation orders)Monitoring of microbial resistance and infection patternsReporting of and education about ASP findings to hospital staff (physicians, nurses, pharmacists, etc.)Technology PlanTo be successful in implementing this Actionable Patient Safety Solution will rely on implanting a technology plan using the following systems. Other specific strategies will be developed or become apparent as the above are implemented. This action plan will include careful observation of the consequences of each new strategy, which will in turn lead to additional novel ideas for further improvement in medication administration safety.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.
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Ariana Longley

and 8 more

Executive Summary ChecklistSevere hypoglycemia (SH) causes significant morbidity and occasional mortality in hospitalized patients. The establishment of an effective program to reduce errors in the recognition and treatment of SH requires an implementation plan that includes the following actionable steps:Establish a commitment from hospital administration and medical leadership to reduce SH.Raise institutional awareness of the issue by comparing hospital and nursing units based on performance quality scorecards.Create a multidisciplinary team that includes physicians, pharmacists, nurses, diabetic educators, medication safety officers, case managers, and long-term healthcare professionals. This team will:Develop a system to identify patients receiving anti-diabetic medications (sulfonylureas, insulins, etc.) in the Electronic Health Record (EHR).Implement real-time surveillance methods, analysis tools, and point-of-care blood glucose (BG) monitoring and reporting systems.Create insulin order sets that could be modified to reduce risks of hypoglycemia.Coordinate glucose monitoring, automate insulin dose calculations, insulin administration, and meal delivery during changes of shift and times of patient transfer.Develop a systematic approach to reduce SH and implement universal best practices.Continuously monitor the incidence of SH in the hospital, and use the results of this monitoring in medical staff education sessions as a part of Continuous Quality Improvement (CQI).The Performance GapHypoglycemia is a common problem for many patients with diabetes, and it can also occur in non-diabetics in a hospital setting.  . Mild episodes can cause unpleasant symptoms and disrupt daily activities. Severe hypoglycemia (SH) can result in disorientation and unusual behavior, and may be life-threatening. Frequent hypoglycemia is associated with increased morbidity, length of stay, and mortality. Hypoglycemia has been associated with mortality in the intensive care units \cite{Elliott_2012}. Moderate and SH are strongly associated with increased risk of death, especially from distributive shock \cite{2012}. This is by means of impairment of autonomic function, alteration of blood flow and composition, white cell activation, vasoconstriction, and the release of inflammatory mediators and cytokines \cite{Adler_2008},\cite{Wright_2008}. The prevalence of hypoglycemia (serum glucose <70 mg/dL) was reported as 5.7% of all point-of-care blood glucose (BG) tests in a 2009 survey of 575 hospitals.\cite{Swanson_2011}. The definition of SH (a low BG level that requires the assistance of another person for recovery), is a level <40 mg/dL, has been adopted as the level likely to cause harmin the hospital setting \cite{Schwartz_2007}. SH is a preventable harm. Early therapeutic management of mild hypoglycemia can prevent more SH episodes. In addition, literature showed that clinicians do not consistently adjust their patient’s anti-diabetic regimens appropriately following treatment of hypoglycemia, placing the patient at additional risk \cite{Boucai_2011},\cite{DiNardo_2006}.Causative factors that may lead to the development of hypoglycemia for inpatients may include excessive insulin dose, inappropriate timing of insulin or anti-diabetes therapy, unaddressed antecedent hypoglycemia or changes in the nutritional regimen, creatinine clearance changes, or steroid dose (9)\cite{Deal_2011}. Failure of effective BG monitoring and communication between physicians, pharmacists and nurses can also contribute to the problem. The diverse nature of potential errors in the treatment of inpatients with SH supports the need for a decision-making model that can be used to predict and prevent SH episodes and improve overall patient safety and outcomes.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 PlanThe plan must include the fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action \cite{51}.Hospital governance and senior administrative leadership (medical, pharmacy, and nursing) must fully understand the performance gaps in their own healthcare system.Hospital  governance,  senior administrative  leadership, and  clinical/safety  leadership must  close  their  own performance gaps by implementing a comprehensive approach.Hospitals  should  set  a  goal  date  for  the  implementation  of  the  corrective  plan,  with  measurable  quality indicators and milestones.Specific   budget   allocations   for   the   plan   should   be   evaluated   by   governance   boards   and   senior administrative leaders.Clinical/safety  leadership  should  endorse  the  plan  and  ensure  implementation  across  all  providers  and systems.Practice PlanEach  hospital  should  create  a  multidisciplinary  team,  which  includes  physicians,  pharmacists,  nurses, diabetic educators, medication safety officers, case managers, and long-term healthcare professionals).Develop a systematic approach to reducing severe hypoglycemia:Identify events and prioritizeRaise institutional awarenessCompare hospitals and nursing units based on performance quality scorecards (use harm rate  for  at-risk  patient  days:  #  of  events/#  of  patient  days  during  hospital  stay  when  a diabetic agent is ordered at any time)Encourage nurses to enter hypoglycemia into safety event self-reporting siteCommunicate to the hospital leadership boardSend letters to physicians and providers (from case managers)Educate  hospital  staff,  providers  and  patients –  hospital  newsletter  and  posters  made  for  each hospital/nursing   unit   listing   known   and  assumed   solutions   to   hypoglycemia   (e.g., “STOP Hypoglycemia!”)Kickoff reception for safety initiativeFrequent monitoring of glucose levels in patients who are at risk.Implement foundational Best Practices and “Just Do Its” (Appendices A and B)Establish a Hypoglycemia Task Force for the hospital ○Propose multidisciplinary diabetes safety team at each hospitalAdopt foundational best practices (literature-based recommendations for all hospitals)Implement “Just  Do  Its!”  (or “Start  Nows”) –  these  should  be  safe  and  reasonable  interventions tested internallyAdopt ISMP recommendations for U-500 insulin precautions (Appendix C)Event investigation and collect causative factorsCausative Factors (to consider as part of analysis tool):Insulin stackingWrong drug, dose, route, patient, or time Insufficient glucose monitoringBasal heavy regimenDecreased nutritional intakeEvent related to outpatient or emergency department drug administrationEvent while treating elevated potassiumGlucose trend not recognizedHigh dose sliding scale insulin 10Home regimen continued as inpatientSignificant reduction in steroid doseSulfonylurea-related hypoglycemiaInsulin administration and food intake not synchronizedPOC glucose reading not linked to insulin administration POC glucose reading not synchronized with food intakeAnalysis tool forms reviewed by either pharmacist and/or nurse in a timely manner (e.g., 72 hours) for causative factors; communicate findings with physician(s)Results  are  collated  and  reported  to  Medication  Safety  Committee  and  the  Pharmacy  and Therapeutics CommitteeIdentify  interventions  (evidence-based  and  expert  opinion)  that  are  used  to  resolve  the  most common or most harmful causative factorsTrack  the  interventions  and  create  customized  action  plans based  on  an  integrated  results dashboardShare best practices within hospital and to other hospitalsShare strategies and implement informed interventions on target floors and patients.Technology PlanSuggested 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.Implement  glycemic  management  clinical  decision  support for  insulin therapy  recommendation,  based  on individual responses to insulin and designed for mitigation of all types of hypoglycemia.This would include all of the following bullet points with significant additional safety features.Implement  real-time  surveillance  method  for  informatics alerts: “High-Risk  Sulfonylurea  Alert”  and “Hypoglycemia Risk Alert”.Implement an automated hypoglycemia event analysis tool  (to discover local causes  of hypoglycemia and guide future interventions).Implement point-of-care BG monitoring and reporting systems, including quality assurance reports to audit compliance with hypoglycemia management goals and restriction of insulin utilization.Implement automated triggers for most common causative factors of hypoglycemia, an electronic tracking system for SH events, interventions used and clinical outcomes.Implement a results dashboard for each nursing unit within the hospital and Best Practices used to resolve the hypoglycemic event(s).Set  restrictions  for  the  prescribing  of  U-500  Regular  Insulin  to  only  specialists  and  under  special circumstances in CPOE.

Ariana Longley

and 8 more

Executive Summary ChecklistAn effective program to reduce the incidence of pediatric adverse drug events (pADEs) and harm should be instituted and combine leadership strategies, software (healthcare IT), hardware (drug compounding systems, drug delivery technology, and physiological monitoring systems), and most importantly people (changes in clinical practice, protocols and education) in protecting pediatric patients by focusing on the following key tasks:Demonstrate board and executive leadership engagement and commitment by aligning hospital-wide strategic goals, accountability and systems to reduce pADEs.Create a multidisciplinary team specialized in neonatal and pediatric medicine that reports regularly to executive leadership, with a focus on pADE.Institute an effective software program for identifying, detecting, and reporting pADEs with analysis of the incidence and characteristics of pADEs and the near-misses.Deploy a closed loop medication administration system by implementing an electronic medication administration record (eMAR) and barcoding, or other auto identification technology with computerized provider order entry (CPOE) and pharmacy for medication administration.Institute proven interventional bundles for pADEs:Standardized order sets and protocols for each admitting diagnosis;CPOE with sophisticated decision support systems (DSS) including medication reconciliation, allergy checking, interaction checking, and dose range checking with alerts;Enhanced pharmacy services including clinical pharmacists on rounds, implementing a double-check process as part of medication verification prior to dispensing high-risk medications, utilizing improved IV compounding tools such as bar code assisted medication preparation system (BCMP), and improving workforce skills to assure correct drug compounding and a pharmacy intervention database;Ensure open communication and standardized medication handoff processes between healthcare teams at shift changes to verify medications are being administered correctly compared to the order, and that patient monitoring parameters for high alert medications are in place;‘Smart’ drug infusion pumps with drug libraries that are harmonized with order sets and enterprise formularies that include pediatric standardized drug concentrations addressing all weight ranges and  are periodically updated based on review of an incident database, alert and override data;Support tools to ensure that the correct concentration of drug in diluent is prepared, taking into account fluid balance for small patients and patients with fluid restrictions, and an infusion rate that is acceptable and within pump capabilities in all areas where children receive care.Select and implement new enterprise clinical information systems and electronic health records, verify and assess that the features of an organization’s healthcare IT system includes full support for best practices in age- and weight-specific prescribing, compounding, dispensing, and administration of pediatric medications.Consider relevant improvement initiatives and opportunities for collaboration in pADE reduction outside of the hospital system.Disseminate pediatric-specific assistive technologies such as eBroselow (or equivalent) to assure that basic capabilities to stabilize and treat acutely ill or injured children are present 24/7 throughout all environments of care.Ensure that the FDA Safety Communication: “Syringe Pump Problems with Fluid Flow Continuity at Low Infusion Rates Can Result in Serious Clinical Consequences” is reviewed and understood by the team. [MG Consider use of a different standardized solution if patient weight and dose volume are beyond the pump's capability]Utilize  Continuous  Quality  Improvement  (CQI)  software  from  infusion  pump  manufacturers  to  monitor drug  library  parameters  on  a  routine  basis  and  to  report the  frequency  of  command  overrides  and  alerts triggered for unsafe practices.The Performance GapAs reported by the Institute for Safe Medication Practices (ISMP), during a 5-year span between 2008 and 2012, there were over 45,000 adverse drug events (ADEs) reported to the US Food and Drug Administration (FDA) in children aged less than 18 years old. Of these, approximately 64% of ADEs (29,298) involved reports of a serious injury, which included 2,935 (6%) deaths, 10,032 (22%) cases that required hospitalization, 1,430 (3%) cases considered life threatening, and 816 (2%) cases of disability \cite{5}(Quarter Watch 2014).Preventing medication errors in pediatric patients poses unique challenges as children are particularly vulnerable to adverse outcomes from medication errors because of the need for weight-based drug dosing involving multiple calculations, dilution of stock drug solutions, immature renal and hepatic functions, and limited ability to communicate side effects \cite{Kaushal_2001},\cite{2011},\cite{23055866}. In addition, drugs may be not have an FDA specific indicationfor children. Greater than 70% of the drugs used in pediatrics have not been studied scientifically in age-specific populations to assess patient safety \cite{23055866},\cite{Lindell_Osuagwu_2009}. Most medications used in the care of children are formulated and packaged primarily for adults. The available dosage forms and concentrations appropriate for administration to neonates, infants and children are limited. Therefore, medications often must be prepared in different volumes or concentrations to accommodate delivery modalities that take into account fluid balance for small patients andpatients with fluid restriction, and, if an infusion pump is required, provide an infusion rate that is acceptable and within pump capabilities. When drugs are not prepared centrally in the pharmacy (i.e., extemporaneous compounding by frontline caregivers), computational errors and admixtures that do not account stability, compatibility, or bioavailability data may represent additional challenges \cite{6}.Studies showed that medication errors in pediatrics are up to three times more likely to be associated with a potential ADE compared to those reported in adults (Kaushal 2001),\cite{Fortescue_2003}. Compared to other pediatric patient groups, the neonatal ICU patient group has the highest error and potential ADE rate. Prioritizing strategies for preventing medication errors and adversedrug events in pediatric inpatients \cite{Kaushal_2001},\cite{Le_2006}. As reported in an earlier study, ADE rates in hospitalized children were substantially higher (15.7 per 1000 patient-days) than previously described \cite{Takata_2008}. However, 22% of all ADEs could be preventable, and 17.8% could have been identified earlier \cite{Takata_2008}.In 2001, the ISMP and the Pediatric Pharmacy Advocacy Group (PPAG) collaborated to produce the nation’s first set of guidelines to reduce pediatric medication errors \cite{7}. The American Academy of Pediatrics (AAP) has also taken a lead in making recommendations to reduce errors \cite{2003}.Closure of performance gaps and “getting to zero” medication errors will require the constant vigilance from all healthcare professionals and the commitment of hospitals and healthcare systems to implement action in the form of specific leadership, practice and technology plans. This will lead to a decrease in medication errors and a reduction in the occurrence of preventable ADEs in pediatric patients.Leadership PlanThe hospital board, executives and other senior administrative leadership (medicine, pharmacy and nursing) must fully understand the performance gaps in reducing pADEs at their own healthcare systems. Commitment from all the leaders and stakeholders is necessary for the successful closure of these performance gaps. Leaders should endorse a comprehensive pADE reduction action plan and ensure implementation across all providers and systems. Strategic and tactical approaches that hospital leadership should endorse include the following:Establish pADE reduction as a strategic priority by creating a clear metric and goal that are included on the hospital-wide dashboard reviewed by the board and senior executives.Invest and allocate funds to:Develop and maintain continuous education programs for healthcare providers with respect to pediatric clinical updates, high alert medications, pADEs monitoring and proper use of drug infusion pumps \cite{Manias_2014},\cite{Cimino_2004},\cite{Keiffer_2015},\cite{11148939},\cite{Wolf_2016}.Develop and maintain continuous education programs for healthcare providers with respect to pediatric clinical updates, high alert medications, pADEs monitoring and proper use of drug infusion pumps. (Manias, Cimino, Keiffer, Stump, Wolf)Support clinical and research programs to develop an educational forum and “Best Practices”model for healthcare providers to expand the body of knowledge in pediatric medicine.Encourage and support the use of a simple, real-time pADE reporting system \cite{Stump2000}.Review accurate, up-to-date pADE data at least monthly \cite{Stump2000}.Encourage and support the use of a simple, real-time pADE reporting system \cite{11148939}.Review accurate, up-to-date pADE data at least monthly \cite{11148939}.Charter a committee or task force to review the reported data at the hospital and unit levels, generate and implement strategies for improvement, analyze barriers and regularly report to executive leadership \cite{11148939}.Expect a comprehensive root cause analysis of all pADEs that involve serious patient harm. The analysis should include the root cause of the medication error, feedback to the individual linked to the error, implementation of time-bound and evidence-based changes to avoid similar pADEs, and widespread sharing of lessons learned \cite{11148939}.Charter a committee or task force to review the reported data at the hospital and unit levels, generate and implement strategies for improvement, analyze barriers and regularly report to executive leadership \cite{Stump2000}.Expect a comprehensive root cause analysis of all pADEs that involve serious patient harm. The analysis should include the root cause of the medication error, feedback to the individual linked to the error, implementation of time-bound and evidence-based changes to avoid similar pADEs, and widespread sharing of lessons learned \cite{Stump2000}.Support the development of a lessons learned program to raise awareness among providers across the spectrum of medication delivery about pADE events, risks and improvement efforts using longitudinal data, individual events and near misses.Assess staffing and ensure an adequate number of medical, nursing and pharmacy staff specially trained to prescribe, prepare, dispense, and administer medications to children (Stucky, Wolf).Promote and enhance collaborative communication among all disciplines participating in neonatal and pediatric patient care, including pharmacy staff, patients and families (Fortescue 2003).Assess staffing and ensure an adequate number of medical, nursing and pharmacy staff specially trained to prescribe, prepare, dispense, and administer medications to children \cite{2003},\cite{15511054}.Promote and enhance collaborative communication among all disciplines participating in neonatal and pediatric patient care, including pharmacy staff, patients and families \cite{Fortescue_2003}.Consider relevant improvement initiatives and opportunities for collaboration in pADE reduction outside of the pediatric hospital system such as ECLIPSE, \cite{Blandford_2016} FDA-ASHP Standardize for Safety (S4S) Initiatives and OCHSPS.Implement and disseminate assistive technologies that support community practitioners as they stabilize, treat and transfer neonates and children in higher levels of care.Practice PlanStandardize pediatric medication treatments and usage, as well as the processes for drug administration in pediatric patients. Some strategies include the following:Establish and maintain a functional pediatric formulary system with policies for drug evaluation, selection and therapeutic use \cite{6},\cite{2003}.Develop and optimize a smart infusion pump drug library with explicit support for intravenous therapy for pediatric patients \cite{Manrique_Rodr_guez_2012},\cite{Manrique_Rodr_guez_2012a}.Prevent timing errors in medication administration by standardizing the number of days considered in all pediatric protocols upon deciding a treatment start date (e.g., Day 0 or Day 1) \cite{6}.Weigh all pediatric patients in kilograms at the time of admission or as soon as possible (i.e., within four hours of admission) in an emergency situation since weight is used to calculate most dosing for children \cite{6}.Standardize and limit the number of concentrations and dosage strengths of high alert medications to the minimum needed to reduce potential medication errors \cite{6},\cite{19412363},\cite{Hilmas_2009},\cite{Murray_2014},\cite{15995017}. High alert medications for pediatric patients should be generated by individual hospitals based on their types of pediatric population, infrastructure and unique features \cite{Doherty_2012},\cite{Glanzmann_2015}.Establish and maintain a functional pediatric formulary system with policies for drug evaluation, selection and therapeutic use (Joint Commission 2008, Stucky).Develop and optimize a smart infusion pump drug library with explicit support for intravenous therapy for pediatric patients (Manrique-Rodriguez 2012).Prevent timing errors in medication administration by standardizing the number of days considered in all pediatric protocols upon deciding a treatment start date (e.g., Day 0 or Day 1)(Joint Commission 2008).Weigh all pediatric patients in kilograms at the time of admission or as soon as possible (i.e., within four hours of admission) in an emergency situation since weight is used to calculate most dosing for children (Joint Commission 2008).Standardize and limit the number of concentrations and dosage strengths of high alert medications to the minimum needed to reduce potential medication errors (Joint Commission 2008, Irwin 2008, Hilmans 2010, Murray 2014, Larson 2005). High alert medications for pediatric patients should be generated by individual hospitals based on their types of pediatric population, infrastructure and unique features (Doherty 2012, Glanzmann 2015).Develop age-related treatment algorithms to guide providers to the correct dosing appropriate for the age of the pediatric patient.Age- and weight-related developmental changes in pediatric patients affect the medication use process of specific drugs, and should be taken into consideration. The age-related treatment algorithms will be useful in preventing the use of medications outside the intended patient population.Use reputable, reliable references and protocols to help standardize pediatric medication therapies.Participate and track the progress of the FDA-ASHP Standardize for Safety Initiative.Evaluate clinical guidelines and protocols on a routine basis for sustainability and safety, especially when limited safety and/or efficacy data are available in the pediatric population.Develop and implement a pediatric trigger toolkit that will electronically identify high risk medications based on the therapeutic levels, dosages and pADEs.Alignment of the trigger toolkit with clinical protocols specific for the medication.Utilization of an ADE trigger tool method to identify possible adverse events have been shown to ensure more patient safety events compared to voluntary reporting \cite{22479163},\cite{Call_2014}.The pediatric trigger toolkit is effective at identifying ADEs and reducing the frequency of sentinel events for hospitalized pediatric populations \cite{Takata_2008}.Create a pediatric multidisciplinary team. This team’s responsibilities will include the following:Achieve hospital-wide pADE reduction goals;Monitor accurate, up-to-date pADE metrics;Collaborate in a multidisciplinary team (e.g., physicians, pharmacists and nurses) to promote and endorse accountability and responsibility in reporting pADEs from all healthcare providers \cite{22768013},\cite{Stratton_2004}.For example, a pharmacy-driven ADE reporting approach, embraced by nurses and physicians, was shown to improve ADE reporting and avoid inconsistency in the information gathered.Develop and ensure comprehensive specialty training for all practitioners involved in the care of pediatric patients, as well as continuous education programs for healthcare providers to stay current and knowledgeable in medications and treatment of pediatric conditions, and be familiar with the ongoing pADE tracking and reporting systems \cite{6},\cite{2003}.Collaborate with the Informatics Technology team to develop and customize CPOE order sets to help standardize care and medication therapy for specific pediatric disease states \cite{Potts_2003}.Develop a team of experts (e.g., physician, pharmacist and nurse) to train healthcare providers at their hospital on how to use the smart infusion pumps with customized pediatric drug libraries \cite{Manrique_Rodr_guez_2012a}.Develop and standardize a smooth and effective communication process for hand-offs (e.g. using a checklist)\cite{26390744},\cite{Halasyamani_2006} upon patient transfer to a different unit within the hospital, and upon the transitions of care within and outside clinical settings \cite{25209739},\cite{Manias_2009},\cite{Apker_2007}.Ensure adequate pharmacy services for pediatric patients to reduce medication errors and ADEs \cite{Manias_2014}. The strategies proposed by the American College of Clinical Pharmacy (ACCP) and PPAG include:\cite{Bhatt_Mehta_2013}Develop and implement pharmacist-managed admission medication histories and medication reconciliation process for pediatric patients, which have shown to prevent potentially significant adverse drug reactions and have a positive impact on patient care \cite{Provine_2014}.Develop and implement a discharge prescription review program, led by a clinical pharmacist (with pediatric training preferred), to ensure the medication doses are equivalent to those prepared in the hospital. This is an effective method for reducing prescribing errors in pediatric patients during transition of care \cite{23055881}.Achieve hospital-wide pADE reduction goals; ○Monitor accurate, up-to-date pADE metrics;Ensure outstanding event reporting systems, root cause analyses, lessons learned processes and improvement strategies for pADE reduction;Develop  an  education  forum  for  community  healthcare  providers  (e.g.,  physicians,  pharmacists and nurses) about appropriate prescribing and dispensing medications for pediatric patients \cite{22768015}.Disseminate  pediatric-specific  assistive  technologies  such  as  eBroselow  (or  equivalent) to  assure that  basic  capabilities  to  stabilize  and  treat  acutely ill  or  injured  children  are  present  24/7 throughout all environments of care \cite{25309147}.Benchmark the adequacy of the features of the individual hospital’s medication safety practices and clinical information systems against the proven best practices, identify gaps, and make recommendations.Collaborate in a multidisciplinary team (e.g., physicians, pharmacists and nurses) to promote and endorse accountability and responsibility in reporting pADEs from all healthcare providers (Crowther 2011, Stratton 2004).For example, a pharmacy-driven ADE reporting approach, embraced by nurses and physicians, was shown to improve ADE reporting and avoid inconsistency in the information gathered (Crowther 2011).Develop and ensure comprehensive specialty training for all practitioners involved in the care of pediatric patients, as well as continuous education programs for healthcare providers to stay current and knowledgeable in medications and treatment of pediatric conditions, and be familiar with the ongoing pADE tracking and reporting systems  (Joint Commission 2008, Stucky 2003).Collaborate with the Informatics Technology team to develop and customize CPOE order sets to help standardize care and medication therapy for specific pediatric disease states (Potts 2004).Develop a team of experts (e.g., physician, pharmacist and nurse) to train healthcare providers at their hospital on how to use the smart infusion pumps with customized pediatric drug libraries (Manrique-Rodriguez 2012).Develop and standardize a smooth and effective communication process for hand-offs (e.g. using a checklist)32,33 upon patient transfer to a different unit within the hospital, and upon the transitions of care within and outside clinical settings (Manias 2015, Manias 2009, Apker 2007).Ensure adequate pharmacy services for pediatric patients to reduce medication errors and ADEs.12The strategies proposed by the American College of Clinical Pharmacy (ACCP) and PPAG include: (Bhatt-Mallak 2007)Elevating the minimum expectations for pharmacists entering pediatric practice,Standardizing pediatric pharmacy education,Expanding the current number of pediatric clinical pharmacists,And creating an infrastructure for development of pediatric clinical pharmacists and clinical scientists.Develop and implement pharmacist-managed admission medication histories and medication reconciliation process for pediatric patients, which have shown to prevent potentially significant adverse drug reactions and have a positive impact on patient care (Provine 2014).Develop and implement a discharge prescription review program, led by a clinical pharmacist (with pediatric training preferred), to ensure the medication doses are equivalent to those prepared in the hospital. This is an effective method for reducing prescribing errors in pediatric patients during transition of care (Christiansen 2008).Implement pharmacist-driven processes, such as developing a double- and triple-check system for high alert medications to ensure the “5 Rights”, appropriate medication selection, and accurate excipients, dose and concentrations of liquid medications prior to compounding and dispensing them.Develop  an  education  forum  for  community  healthcare  providers  (e.g.,  physicians,  pharmacists and nurses) about appropriate prescribing and dispensing medications for pediatric patients (Benavides 2011).Disseminate  pediatric-specific  assistive  technologies  such  as  eBroselow  (or  equivalent) to  assure that  basic  capabilities  to  stabilize  and  treat  acutely ill  or  injured  children  are  present  24/7 throughout all environments of care (Damhoff 2014).Technology PlanSuggested 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.Technology has significantly advanced  in the last  decade  within  the  healthcare  setting  with  development  of Electronic Health Records (EHR), CPOE, barcode medication administration (BCMA), bar code assisted medication preparation system (BCMP) and smart pump infusion technology. Multiple studies in pediatrics have demonstrated a decrease   in   both   prescribing   errors   and   ADEs   after   implementing   these   technologies (Manias 2014, Larsen 2005, Morriss 2009, Tourel 2012, Mason 2014, Morriss 2011, Hardmeier 2014, King 2003, Leung 2015, Manrique-Rodriguez 2016, Rinke 2014). However, most of these systems are designed for use in adult patients and customization is often needed to  ensure optimal use in pediatric patients (Ruano 2016).Work with the multidisciplinary healthcare team to develop,  improve  and  optimize  the  pADE  reporting systems to identify, target, track and monitor pADEs.Embed  a pediatric trigger toolkit in the CPOE  as  an  alert system  for  prescribers  when  medications  are ordered out of range or are duplicate therapies (Takata 2008, Burch 2011, Call 2014).Develop  and  optimize  real-time  surveillance  systems  to identify  high  risk/high  alert  medications  and  to optimize pediatric patient outcomes via mitigation of pADEs.Standardize equipment and measurement systems throughout the institution, such as smart infusion pumps and accurate weight scales for pediatric patients (Stucky 2003).Ensure best practices are used for syringe pumps with medications requiring low infusion rates (<5 mL per hour) to prevent medication errors  (FDA Safety Communication 2016, Sherwin 2014).Ensure that the FDA Safety Communication: “Syringe Pump Problems with Fluid Flow Continuity at Low Infusion  Rates  Can  Result  in  Serious  Clinical  Consequences”  is reviewed  and  understood  by  pharmacists who  dispense  drugs  for  use  in  programmable  syringe  pumps,  by  clinical  engineers  and  technicians  who maintain  programmable  syringe  pumps,  and  by  caregivers  who use  or  who  train  users  on  programmable syringe pumps (FDA Safety Communication 2016).Promote  eLearning  modules  on  this  topic, (Massachusetts General Hospital Anesthesia)  prepared  by  Massachusetts  General  Hospital,  are freely   available   at   syringeinfusionsafety.org   as   referenced   by   the   FDA   in   the   Safety Communication.Implement  and  optimize  bar  coded  medication  process  for  pediatric  medication  products  (e.g., multi-dose or unit-dose vials, compounded, and/or repackaged).(ASHP Foundation)Use   a   bar   code   assisted   medication   preparation   system   (BCMP)   for   intravenous   sterile compounding  in  pharmacy,  such  as  Baxter’s  DoseEdge  Pharmacy  Workflow  Manager,  BD’s Cato™ Medication Workflow Solutions, and Omnicell’s i.v.SOFT® Assist.Use the eBroselow System (or equivalent) as an electronic aid to assist those who compound drugs extemporaneously,  in  achieving  compliance  with  standardized  concentrations  that  respect  fluid balance  considerations  for  small  patients  and  patients  with  fluid  restriction,  and  are  compatible with the performance envelope of drug infusion pumps (Damhoff 2014).Use the Codonics Safe Label System,56 or the BD Intelliport Medication Management System, to assure  correct  source  vial  identification,  container  preparation, and  Joint  Commission-  compliant labeling of drugs given by IV push or infusion in the perioperative environment (Nanji 2016).Utilize  Continuous  Quality  Improvement  (CQI)  software  from  infusion  pump  manufacturers  to  monitor drug  library  parameters  on  a  routine  basis  and  to  report the  frequency  of  command  overrides  and  alerts triggered for unsafe practices (Ohashi 2013, Bergon-Sendin 2015).Analyze  and  proactively  respond  to  identified  issues  from  smart  pump  data  to  minimize  use  of basic mode.Develop systems to perform gap and root cause analyses to improve patient and medication safety.With technology prevalent in healthcare, physicians, pharmacists and nurses should use both synchronous and  asynchronous  forms  of  communication  to  improve  medication  safety  at  the  transitional  points  of care (Manias 2009).Develop  and  optimize  communication  technology  across  healthcare  settings,  providers  and  caregivers  of the pediatric patients via secured HIPAA-protected lines (e.g., telemedicine and apps).

Ariana Longley

and 11 more

Executive Summary ChecklistHypoxia in preterm infants can result in severe morbidity and mortality. Supplemental oxygen administration helps avoid hypoxia but hyperoxia can cause retinopathy of prematurity and increased risk for other conditions. Implementing an optimal oxygen targeting guideline can improve neonatal outcomes. To address suboptimal oxygen targeting:Make an organization-wide commitment by administrative, clinical, and patient engagement leaders to address neonatal patient safety related to oxygen administration.Assess opportunities to improve oxygen administration and monitoring for the prevention of adverse events due to lack or excess of oxygen.Implement interdisciplinary strategies and develop an action plan with a timeline with concrete milestones to implement an optimal oxygen guideline for neonates.Select technologies that have been shown to improve neonatal outcomes, including but not limited to: blenders, pulse oximetry, and heated humidifiers.Use blenders in all circumstances when administering oxygen, including the delivery room.Bird, Carefusion, Precision Medical’s low-flow and high-flow oxygen-air blendersUse heated humidifiers when using CPAP and in all circumstances where the infant is intubated, even for a few minutes.Fisher & PaykelUse heated humidifiers in the delivery room.For pulse oximetry, select equipment that: a) can measure through motion and low perfusion conditions to avoid inaccurate measurements/false alarms and identify true alarms; and b) has been proven effective for neonatal oxygen targeting.Masimo Signal Extraction Technology (SET) pulse oximetry (until another technology is proven to be equivalent)Determine the oxygen targeting guideline that healthcare providers should implement:The SpO2 for a preterm baby breathing supplemental oxygen should not exceed 95%.The SpO2 for other larger infants and neonatal patients breathing supplemental oxygen should stay in the range of 88-95 or 90-96% depending on infant and condition.When SpO2 dips below the desired % or when the low alarm sounds, avoid a response that results in high saturation (>95%).In order to accomplish this, the monitor alarms should always be on and active when an infant is breathing supplemental oxygen.Neonates in an intensive care environment should always be monitored by a pulse oximeter capable of monitoring through motion and low perfusion with appropriate alarm limits.The high SpO2 alarm should be set to 95%, depending on the infant.The low SpO2 alarm should be set no lower than 85%.Alarms signaling should receive attention from the nurse/doctor/respiratory therapist.When a baby is not breathing supplemental oxygen or receiving any form of respiratory support, but is being monitored for desaturations, the low SpO2 alarm should be set at 85% and the high alarm can be turned off.Implement your action plan for including educational activities, workshops, and tools for all members of the neonatal healthcare team.Develop a process for continuous improvement by communicating with staff and implementing measures to improve processes in order to meet the oxygen targeting objective.The Performance GapIt has been clear for many decades that avoiding hypoxia in neonatal care is associated with increased survival and lower rates of cerebral palsy, other significant neurologic compromise. For this reason, hypoxia should be avoided; this is not to say that hyperoxia should be allowed. Supplemental oxygen in newborn infants has been over-utilized worldwide. This practice has been associated with prolonged hospitalizations, blindness for life due to retinopathy of prematurity (ROP), cancer in childhood, chronic lung disease, developmental disabilities, periventricular leukomalacia, cerebral palsy and other oxidant-stress related adverse effects including DNA damage, endocrine and renal damage, decreased myocardial contractility, alveolar collapse, infection, inflammation and fibrosis \cite{Collins_2001,12769184,17537007,15613575,18458550,18446174}. Most if not all of these complications are as a result of care in the newborn period and cannot be fully eradicated. However, evidence shows eliminating inappropriate oxygen administration and increasing the use of oxygen monitoring can lead to significantly decreased rates of these preventable conditions \cite{24838096,Sola_2015}.The use of unnecessary oxygen or suboptimal administration of oxygen, and the resulting prolonged hospital stays add significantly to health care costs, not to mention the tremendous emotional costs of preventable chronic conditions. Actively addressing the administration and monitoring of oxygen in newborn infants to prevent both hypoxia and hyperoxia can realize significant improvements in the quality and safety of healthcare as well as cost savings \cite{23268664}.Hospital practices for oxygen monitoring are variable. Many delivery rooms and neonatal intensive care units worldwide adhere to outdated or otherwise inappropriate protocols. The evidence has shown that excessive oxygen administration during the first few minutes of life is noxious. Yet, in many delivery rooms worldwide, pure oxygen (100% O2) is still administered unnecessarily, FiO2 is not measured, and oxygen saturation (SpO2) levels are not adequately monitored \cite{21091987,Shah_2012,Bizzarro_2013,Chow_2003,Deulofeut_2006,2010}. Therefore, there is an opportunity to prevent many adverse effects through education on appropriate oxygen management, such as the measurement of oxygen titration with a blender and monitoring the infant’s saturation level with pulse oximetry technology that can measure through motion and low perfusion \cite{12563061}.In a two-phased study of two centers that previously used conventional pulse oximetry, both centers simultaneously changed their neonatal oxygen targeting guideline, and one of the centers switched to Signal Extraction Technology pulse oximetry.14 In the first phase of the study, there was no decrease in retinopathy of prematurity at the center using non-Signal Extraction Technology; but there was a 58% reduction in significant retinopathy of prematurity and a 40% reduction in the need for laser eye treatment at the center using Signal Extraction Technology. In the second phase of the study, the center still using non-Signal Extraction Technology switched to Signal Extraction Technology and it experienced similar results as the center already using Signal Extraction Technology.  In the follow up study, the outcomes of 304 very low birth weight infants whose oxygen targeting was performed with non-Signal Extraction Technology pulse oximetry were compared with 396 post-initiative infants whose oxygen targeting was performed after switching to Signal Extraction Technology pulse oximetry.13 After switching to Signal Extraction Technology, there was a 59% reduction in incidence of severe ROP and a 69% reduction in ROP requiring surgery.A summary of recent publications on extremely premature infants randomly assigned to a lower target oxygen-saturation intention to treat (85 to 89%) or higher target SpO2 intention to treat (91 to 95%) has shown there was neither increased mortality nor serious brain injuries as a result of avoiding hyperoxia in preterm infants \cite{Stenson_2011,Saugstad_2011,Castillo_2008,Askie_2011}. Also a recent presentation by Askie et al (Cochrane review) shows that there is no difference in the primary outcome of death or disability between the two intentions to treat studied, a higher (91-95%) versus a lower (85-89%) arterial oxygen saturations. Higher rate of NEC occurred with lower intention to treat (85-89%) and a higher rate of severe ROP with higher target range (91-95%). Recently the Committee on Fetus and Newborn of the AAP have made clinical recommendations which are included in this document \cite{Cummings_2016}.Therefore, an intention to treat with SpO2 of 85-89% should be avoided. There are several issues that suggest extreme caution should be used in the interpretation of these randomized controlled trials \cite{Manja_2015,25357098,24973289}. Additionally, narrow ranges are difficult to maintain for more than 50-60% of the time \cite{Di_Fiore_2014}. To date, the “perfect” SpO2 target range is still not known for all newborns at all times \cite{Saugstad_2010}.In summary, in extremely low birth weight infants the ideal oxygen saturation range or intention to treat remains unknown and is a compromise among negative outcomes associated with either hyperoxemia (ROP, BPD) or hypoxemia (NEC, death). The appropriate SpO2 range for an individual infant will depend on the type of SpO2 monitor used, gestational age, postnatal age, hemoglobin A concentration, hemoglobin level, oxygen content, cardiac output, clinical diagnosis and illness severity \cite{Castillo_2010}. Despite this variability, it is clear that in order to improve clinical outcomes, some clinical practices must be eradicated and replaced with guidelines of clinical care aimed at avoiding both hyperoxia and hypoxia.Alarms:Alarms should always be operative (do not disconnect or deactivate alarms).Alarm limits are used to avoid harmful extremes of hyperoxemia or hypoxemia.Busy NICU nurses respond much better to SpO2 alarms rather than to “mental SpO2 target ranges or intention to treat”.Given the limitations of SpO2 and the uncertainty regarding the ideal SpO2 intention to treat for infants of extremely low birth weight, wider alarm limits are easier to target.The lower alarm limit generally needs to extend somewhat below the lower SpO2 chosen as the intention to treat. It must take into account practical and clinical considerations, as well as the steepness of the oxygen saturation curve at lower saturations. It is suggested that the low alarm for extremely low birth weight infants be set no lower than 85% ( 86-87% may also be appropriate).The upper alarm limit should not be higher than 95% for extremely low birth weight infants while the infant remains on supplemental oxygen or any form of ventilatory support.ROP and other morbidities can be exacerbated by hyperoxemia. For example, at 5 years of age, motor impairment, cognitive impairment and severe hearing loss are 3 to 4 times more common in children with than without severe ROP.Based on these considerations, there is a need to introduce clinical measures at all institutions caring for newborn infants to close the gap between knowledge and practice. The lack of a systematic approach to prevent hypoxia and hyperoxia significantly affects patient safety, quality, and cost of care. Closing the performance gap will require hospitals, healthcare systems and all members of the neonatal health care team (RN’s, RT’s and MD’s) to commit to action in the form of specific leadership, practice, and technology plans to improve safety for newborn infants who require oxygen supplementation.Leadership PlanImplement a plan that includes fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, ability, and action \cite{sonot1}.Hospital governance and senior administrative leadership commit to become aware of this major performance gap in their own healthcare system.Hospital governance, senior administrative leadership, and clinical/safety leadership close their own performance gap by implementing a comprehensive approach to addressing the performance gap.Set a goal date to implement the plan to address the gap with measurable quality indicators - “Some is not a number. Soon is not a time" \cite{sonot2}.Allocate a budget for the plan to be evaluated by governance boards and senior administrative leaders.Clinical/safety leadership endorse the plan and drive implementation across all providers and systems.Collect data and perform analysis to be used for implementation and assessment of outcomes.Address and readdress two questions for quality improvement and to address gaps: Are we doing the right things? Are we doing things right?

Ariana Longley

and 12 more

Executive Summary ChecklistCongenital Heart Disease (CHD) is one of the most common types of birth defects. Critical Congenital Heart Disease (CCHD), including ductal-dependent lesions, represents 40% of death caused by CHD. CCHD is life-threatening and is typically identified in the first year of life. Early intervention in CCHD is imperative and remains an important clinical challenge. Historically, due to the lack of physical signs and difficulties in screening mild cyanosis in newborns, a third of babies were discharged unchecked. A fetal ultrasound can identify increased structural abnormalities and proportions; however, this detailed ultrasound is operator-dependent and potentially inconsistent. Pulse oximetry screening is a universally accepted test that increases overall detection of CCHD to over 90% and identifies babies with non-cardiac, hypoxemic conditions such as congenital pneumonia, early-onset sepsis, and pulmonary hypertension as well.To address the failure to detect CCHD in newborns, we should implement the following actionable steps:Make an organization-wide [MG nationwide] commitment to implement a universal pulse oximetry screening program for newborns.Develop an action plan to immediately implement a universal pulse oximetry screening program.Select technology proven to be effective for newborn screening. The technology must monitor and accurately read through during motion and low perfusion. Masimo Signal Extraction Technology (SET) pulse oximetry (until another technology is proven to be equivalent) [MG I would present this just as SET. This is a Masimo trademark.] Determine the screening protocolAge at screening: >24 hours or prior to dischargeObtain pulse oximetry measurements from preductal (right hand) and postductal (either foot) sites [MG In CCHD, the right hand may be post ductal. Both hands is potentially better than right hand and foot. May just want to say pre and post ductal] Screening results which will be considered positive and require further investigationSpO2 <90% from any site; orSpO2 <95% from the right hand or either footIf initial SpO2 measurement is <95%, proceed with up to two additional SpO2 measurements.If the second and third SpO2 measurements read >95% the screening is negative.If the second and third SpO2 measurements are <95% the screening is positive.>3% difference in SpO2 measurements between the right hand and either foot (repeat three times as described in the bullet above)Additionally, if the Perfusion Index (PI) <0.7 that should increase the need for assessment of the baby (if <0.4 the baby should be immediately assessed)Educate clinical staff on proper screening, strategies for family education and engagement, follow-up protocols for positive screens, and results reporting policyDevelop a process for continuous improvement by educating and communicating with staff and implementing measures to improve processes in order to meet the universal newborn screening objective.The Performance GapCongenital heart disease (CHD) is the most common birth defect, affecting approximately 8 in 1,000 live-born infants \cite{Reller_2008,Bernier_2010}. Nearly 40,000 infants are born with CHD per year in the US, and 1.35 million globally \cite{Hoffman_2002,22078432}. Critical congenital heart disease (CCHD), including ductal dependent lesions, affects between one-quarter and one-third of these infants \cite{Oster_2013,26086632,25963011}. CCHD represents about 40% of the deaths from congenital anomalies and the majority of the deaths due to CHD that occur in the first year of life.(Hoffman 2002) In 2012, before newborn screening programs were introduced in the United States, it was estimated that between 70-100 infants died each year from late-diagnosed CCHD \cite{Govindaswami_2012}. It is now believed that the number of deaths is closer to 120 per year \cite{28837548}. [MG these two sentences don't work well together; after screening, are we seeing increased or decreased death?]Antenatal ultrasound and physician examination after birth improve detection and perinatal outcomes for certain forms of CCHD \cite{Tworetzky_2001,Bonnet_1999}. Evidence showed that prenatal detection increased every year (2006-2012); prenatal detection now occurs in 34% of patients \cite{Quartermain_2015}. The benefit of a CCHD diagnosis before birth allows for counseling and coordination of delivery at an experienced cardiac center.The gap in patient safety is that more than 30 percent of CCHD deaths have been attributed to late or missed diagnosis \cite{Chang_2008}. It is estimated that 2,000 infants/year die or are undiagnosed in the US and some 300,000 infants/year die globally \cite{Salvi_2016}. The burden of undiagnosed cases in the developing world is significant, with fewer than half of CHD cases diagnosed in the first week of life \cite{Hoffman_2013}. The magnitude of the problem has been extensively documented \cite{Singh_2014,de_Wahl_Granelli_2014,Ewer_2014,Ewer_2014a,Ewer_2013,Ewer_2013a,GRANELLI_2007}.Pulse oximetry noninvasively measures oxygen saturation (SpO2) and pulse rate.  In 2009, de-Wahl Granelli et al published a breakthrough cohort study in which 39,821 infants were screened for CCHD by identifying abnormal SpO2 measurements from Signal Extraction Technology (SET) pulse oximetry. SET's ability to measure through motion and low-perfusion is essential for accurate CCHD screening \cite{de_Wahl_Granelli_2009}. In a separate CCHD screening study of 20,055 asymptomatic newborns, Ewer et al, confirmed the importance of utilizing SET technology that can “produce accurate saturations that are stable in active neonates and in low perfusion states, making them suitable for use in the first few hours of a newborn baby’s life" \cite{22284744}. In 2014, Zhao et al reported similarly positive results from a prospective study using SET in more than 100,000 newborns in China \cite{24768155}.The addition of pulse oximetry screening to antenatal ultrasound and physical examination may increase detection rates for CCHD to over 90%. Furthermore, the detection of non-critical CHDs and significant non-cardiac neonatal conditions, such as respiratory problems or early-onset sepsis, is an additional benefit. However, clinicians need to be aware that, although combining pulse oximetry screening with other screening methods will reduce this diagnostic gap, some babies will still be missed. The Journal of Pediatrics has published a study estimating the number of infants with critical congenital heart defects (critical CHDs) potentially detected or missed through universal screening for critical CHDs using pulse oximetry \cite{23266220}. CDC researchers estimated that about 1,755 infants with critical CHDs would be diagnosed late (meaning on or after the third day after birth). Of these, about half (875 infants) with a critical CHD would be detected through newborn screening using pulse oximetry, but an equal number (880 infants) might still be missed each year in the United States.Most studies report that the lesions most often missed are those causing obstruction to aortic outflow (e.g. coarctation and interrupted arch), which may not necessarily be detected in antenatal ultrasound, physical examination, or by abnormal SpO2 values from pulse oximetry. However, an additional SET pulse oximetry measurement may increase detection of CCHD with obstructions to aortic outflow. This measurement is called perfusion index (PI), which is an assessment of strength of perfusion at the monitored site. In a 2007 study, Granelli showed that adding abnormal PI to pulse oximetry screening may increase sensitivity to identifying CCHD with an obstruction to the aortic outflow. The authors of this study also noted that adding PI to the screening criteria may also result in an increase in false positives. [MG reference?]In 2011, the federal CCHD workgroup, with members selected by the US Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and Children, the American Academy of Pediatrics, the American College of Cardiology Foundation, the Newborn Foundation, the March of Dimes, and the American Heart Association, developed a report: Strategies for Implementing Screening for Critical Congenital Heart Disease \cite{21987707}. After a thorough review, the workgroup relied upon a thorough body of evidence and independent published studies to recommend that “screening be performed with motion tolerant pulse oximeters that report functional oxygen saturation, have been validated in low-perfusion conditions, have been cleared by the FDA for use in newborns, and have a 2% root mean-square accuracy.”Several domestic and international studies have shown parents are predominantly satisfied with pulse oximetry screening and those whose babies had a false positive result were no more anxious than those with true negative tests (Ewer 2012). Parents generally perceived it as an important and valuable test to detect ill babies. Additionally, all staff groups (healthcare assistants, midwives, nurses and doctors) were predominantly positive about the testing procedure and perceived the test as important.Screening for CCHD not only reduces pain and suffering of infants and families but can also reduce costs associated with severe cardiovascular and other organ or neurological compromise upon delayed admission to a cardiac unit – and has been tied to significantly reduced mortality, fewer poor surgical outcomes, and lower incidence of prolonged ventilation and potential developmental issues \cite{23918890}.Relative to the developing world, the prevalence of certain heart lesions varies significantly on the global map, as does the burden of hypoxemia-related conditions such as neonatal pneumonia, sepsis, necrotizing enterocolitis (NEC), and PPHN.(Hoffman 2013) Every year nearly 41% of all under-five child deaths are among newborn infants, babies in their first 28 days of life or the neonatal period \cite{world2012newborns}. Three-quarters of all newborn deaths occur in the first week of life, and 1/3 of these newborn deaths are from infection, such as pneumonia, tetanus, and sepsis.30 Each of these conditions are likely to manifest with below normal oxygen saturation. Some are preventable deaths in that when diagnosed in a timely fashion, a course of antibiotics and/or supplemental oxygen therapy can save a life or improve an outcome.Considerations regarding algorithms for screeningA recent review describes the experience of CCHD screening in the United States in reference to optimizing the algorithm for screening,  educating all stakeholders and performing screening using the proper equipment \cite{27244826}. There are many factors to consider when determining the optimal screening algorithm, including the balance of sensitivity and specificity, resource utilization, cost, high altitude and timing of screening. For this reason, other screening protocols have been evaluated in the United States and in other countries \cite{27940777,27603536}. For this reason, other screening protocols have been evaluated in the United States and in other countries. For example, infants at high altitude may have a lower oxygen saturation than those at sea level with potential implications at elevations over 6,800 feet. Therefore, to identify the optimal algorithm in particular settings, it may be necessary to modify the screening protocol described in this document, including the saturation cutoff points and the timing of screening.A certain degree of controversy still remains, and debate continues regarding the most appropriate time to screen, the most effective screening pathway, what saturations are acceptable, which conditions are we trying to identify and screening outside the well-baby nursery.When evaluating algorithms, it is important to consider sensitivity, specificity, and false-positive and false-negative rates. It is also vital that screening leads to timely diagnosis (ie, before presentation with acute collapse).The screening should be pre-and post-ductal as analysis of raw saturation data from infants who had both limb measurements shows that some infants with CCHD would be missed by postductal testing alone.False-positive rate is significantly higher with earlier testing (<24 hours). This led to recommendations that screening be performed after 24 hours of age.However, analysis of recent studies show that many false-positive tests (30%–80%) have alternative non-cardiac conditions (eg, congenital pneumonia, early-onset sepsis, or pulmonary hypertension), which may be equally as life-threatening as CCHD if diagnosed late.In published studies that adopted earlier screening (< 24 hours) the false-positive rate was higher, but more non-cardiac disease was identified.In some countries, mothers and infants are discharged from the hospital within 24 hours after birth, and an increasing proportion is born at home. In these circumstances, screening in hospital > 24 hours is not practical.Additionally, infants at high altitude may have a lower oxygen saturation than those at sea level with potential implications for screening for CCHD at elevations over 6,800 feet. Therefore, to identify the optimal algorithm in particular settings, it may be necessary to modify the screening protocol described in this document, including the saturation cutoff points and the timing of screening.Although usually reserved for former premature infants going to high altitude, any infant who fails high altitude stress testing (HAST) also merits special consideration and may require an echocardiogram to confirm normal anatomy.Be all this as it may, if SpO2 is < 90% in either limb the infant needs to be assessed immediately. If SpO2 is between 90-94% in one or both limbs and the infant does not look completely healthy, clinical assessment is mandatory without delays for repeated measurements. If an infant is completely healthy, the measurement should be repeated as described. Finally, there is no need to do an echocardiogram immediately, as many babies with positive screening do not have CCHD. [Mg this last sentence is confusing and should be removed,  a failed algorithm occurs in a two hour period; we don't want babies sent home without an echo because there is no need to do an echo immediately]In summary, the lack of a systematic approach to prevent failure to rescue in CCHD significantly affects patient safety, quality, and cost of care. Universal newborn screening with pulse oximetry technology has been shown to increase the detection of CCHD by identifying potential abnormalities that are not apparent in prenatal or postnatal examinations.  Closing the performance gap with CCHD will require hospitals, healthcare systems and all members of the neonatal healthcare team (RN’s, RT’s and MD’s) to commit to action in the form of specific leadership, practice, and technology plans for all newborn infants.Leadership PlanImplement a plan that includes fundamentals of change outlined in the National Quality Forum safe practices, including awareness, accountability, and action.Hospital governance and senior administrative and medical and nursing leadership commit to becoming aware of this major performance gap in their own healthcare system.Hospital governance, senior administrative leadership, and clinical/safety leadership close their own performance gap by implementing a comprehensive approach to addressing the performance gapSet a goal date to implement the plan to address the gap with measurable quality indicators.Allocate a budget for the plan to be evaluated by governance boards and senior administrative leaders.Clinical/safety leadership endorse the plan and drive implementation across all providers and systems.Conduct data collection and analysis to be used for implementation and assessment of outcomes.