Executive Summary Checklist

• Gain commitment from senior  leadership to make hand hygiene compliance an organizational priority by setting clear requirements and an adequate budget for:

• Staff Performance
• Performance Measurement and Feedback that is timely and actionable
• Accountability for Performance Improvement at facility and unit leadership levels as part of an overall Organizational Hand Hygiene Guideline. Cascade this message to the entire organization on an on-going basis.        

• Ensure that alcohol-based hand rubs and soap are available as close to the point of care as is reasonable.
• Establish a hand hygiene team responsible for implementation of the Hand Hygiene Protocol.

• The protocol should include mandatory training for all healthcare workers (HCWs) upon hire and on-going at least once annually. Training to include:

• Proper technique for hand rubbing and soap and water washing
• Indications for hand rubbing vs soap and water washing (WHO or CDC Guideline)
• How to speak up when fellow HCWs do not comply (psychological safety is a vital condition of an effective safety culture)

• Education for patients, family members and visitors. 
• Performance Evaluation and Feedback

• It is essential to measure hand hygiene compliance accurately and reliably using a validated method capable of capturing and reporting on 100% of all hand hygiene events such as an evidence-based electronic hand hygiene compliance system. Such systems have been shown to lead to sustainable improvement, reduced infections & costs and a positive impact on patient safety culture \cite{Bouk_2016} \cite{Kelly_2016}\cite{Michael_2017}\cite{Son_2011}.
• Measure hand hygiene compliance using an evidence-based, validated electronic hand hygiene compliance system. 
• Provide performance feedback to unit leadership and frontline staff on a daily or weekly basis using evidence-based behavior change feedback models \cite{21775022}. 
• Follow technology suppliers’ evidence-based recommendations for how to best implement technology and provide timely feedback to healthcare workers.

• Reminders in the workplace such as posters, brochures, leaflets, badges, stickers, etc. can be used provided they are consistent with the overall Hand Hygiene Protocol and any organizational wide campaigns to focus attention on the importance of hand hygiene. 

Executive Summary Checklist

• 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 protocol

• Age at screening: >24 hours or prior to discharge
• Obtain 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 investigation

• SpO2 <90% from any site; or
• SpO2 <95% from the right hand or either foot

• If 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 policy

• Develop 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 Gap

Considerations regarding algorithms for screening

• 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.

Leadership Plan

• Implement 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 gap
• Set 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.

Executive Summary Checklist

• 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 blenders

• Use heated humidifiers when using CPAP and in all circumstances where the infant is intubated, even for a few minutes.

• Fisher & Paykel

• Use 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 Gap

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.

Leadership Plan

• Implement 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?

Executive Summary Checklist

• 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 Gap

Leadership Plan

• The 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 Plan

• Each  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 prioritize
• Raise institutional awareness

• Compare 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 site
• Communicate to the hospital leadership board
• Send 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 initiative
• Frequent 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 hospital
• Adopt foundational best practices (literature-based recommendations for all hospitals)
• Implement “Just  Do  Its!”  (or “Start  Nows”) –  these  should  be  safe  and  reasonable  interventions tested internally
• Adopt ISMP recommendations for U-500 insulin precautions (Appendix C)

• Event investigation and collect causative factors

• Causative Factors (to consider as part of analysis tool):

• Insulin stacking
• Wrong drug, dose, route, patient, or time 
• Insufficient glucose monitoring
• Basal heavy regimen
• Decreased nutritional intake
• Event related to outpatient or emergency department drug administration
• Event while treating elevated potassium
• Glucose trend not recognized
• High dose sliding scale insulin 10
• Home regimen continued as inpatient
• Significant reduction in steroid dose
• Sulfonylurea-related hypoglycemia
• Insulin administration and food intake not synchronized
• POC glucose reading not linked to insulin administration 
• POC glucose reading not synchronized with food intake

• Analysis 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 Committee
• Identify  interventions  (evidence-based  and  expert  opinion)  that  are  used  to  resolve  the  most common or most harmful causative factors
• Track  the  interventions  and  create  customized  action  plans based  on  an  integrated  results dashboard
• Share best practices within hospital and to other hospitals

• Share strategies and implement informed interventions on target floors and patients.

Technology Plan

• 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.

Executive Summary Checklist

• Commitment from hospital leadership to support a program to reduce and then eliminate CLABSIs.
• Implement   evidence-based   guidelines   to   prevent  the   occurrence  of   CLABSIs,   including:   insertion, maintenance, and standardized access procedures.

• Such  as:  Arrow  International®  PSI  with  Integral  Hemostasis   Valve/Side  Port  or  Pressure Injectable  Quad-Lumen  Central  Venous  Catheterization  Kit  with  Blue  FlexTip®,  ARROWg+ard Blue PLUS® Catheter and Sharps Safety Features

• Doctors should:

• Perform a “time-out”
• Wash their hands with soap.
• Clean the patient’s skin with chlorhexidine antiseptic.
• Put sterile drapes over the entire patient.
• Wear a sterile mask, hat, gown and gloves.
• Put a sterile dressing over the catheter site.

• Develop  an  education  plan  for  attendings,  residents  and  nurses  to  cover  key  curriculum  pertaining  to  the prevention, insertion and maintenance of central lines.
• Encourage  continuous  process  improvement  through  the  implementation  of  quality  process  measures  and metrics.
• Standardize a central-line kit based on the needs of your facility, and implement technology that will have a significant return on investment (ROI) such as:

• Arrow International® PSI Kit with Integral Hemostasis Valve/Side Port or Arrow International® Pressure  Injectable  Quad-Lumen  Central  Venous  Catheterization  Kit  with  Blue   FlexTip®, ARROWg+ard Blue PLUS® Catheter and Sharps Safety Features.

• Efforts  should  be  focused  on  eliminating  all  blood  draws  from  central  access  catheters.  This  includes patient with longer-standing catheters (e.g. dialyses catheters).
• All CLABSIs should have a root cause analysis (RCA) completed by the unit where the infection occurred with  multidisciplinary  participation  including nursing,  physicians  and infection  prevention  specialists.  All learnings from the RCA should be implemented.

The Performance Gap

Leadership Plan

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

In addition to the change management model leaders should:

• Include  fundamentals  of  change  outlined  in  the  National  Quality  Forum  safe  practices,  including awareness, accountability, ability, and action.
• Meet  with  ICU  team,  infection  control  staff,  quality  and  safety  leaders,  nurse  educators,  and  physician champions.

• Understand barriers (walk the process)
• Use 4E grid to develop strategy to engage, educate, execute and evaluate
• Engage: stories, show baseline data
• Educate staff on evidence
• Execute practice change
• Evaluate feedback performance, view infections as defects
• Use surveillance data to drive improvement
• Monitor and provide feedback of compliance with best practice over time

Practice Plan

Insertion

• Create a standardized central line insertion kit or line cart that contains all needed supplies (see Technology Plan).
• Ensure insertion checklist is in your electronic medical record.
• Wear sterile clothing – gowns, mask, gloves and hair covering.
• Cover patient with a sterile drape, except for a very small hole where line goes in.
• Maintain strict sterile technique when placing the line.
• Hand  Hygiene  -  Perform  hand  hygiene  procedures,  either  by  washing  hands  with  conventional  soap  and water  or  with  alcohol-based  hand  rubs  (ABHR).  Hand  hygiene  should  be  performed  before  and  after palpating  catheter  insertion  sites  as  well  as  before  and  after  inserting,  replacing,  accessing,  repairing,  or dressing  an  intravascular  catheter \cite{Boyce_2002}.  Palpation  of  the  insertion  site  should  not  be  performed  after  the application of antiseptic, unless aseptic technique is maintained \cite{12517020}.
• Ultrasound guidance should be used for all non-emergent central line placements.
• For  directly  inserted  central  lines,  avoid  veins  in  arm  and  leg,  which  are  more  likely  to  get  infected  than veins in chest.
• Before commencing the procedure, perform a “time-out.”
• Position patient appropriately

Prepare insertion site

• Prepare  clean  skin  with  a  0.5%  chlorhexidine  preparation  with alcohol  before  central  venous  catheter and peripheral  arterial  catheter  insertion  and  during  dressing  changes.  If  there  is  a  contraindication  to chlorhexidine, tincture of iodine, an iodophor, or 70% alcohol can be used as alternatives.
• No iodine ointment - Do not use topical antibiotic ointment or creams on insertion sites, except for dialysis catheters, because of their potential to promote fungal infections and antimicrobial resistance.
• When inserting near the lungs, ensure line aspirates blood to ensure proper catheter placement.
• Apply a sterile dressing to the site.
• Prepackaged or filled insertion cart, tray or box – cart/tray/box that contains all the necessary supplies.
• Insertion checklist with staff empowerment to stop non-emergent procedure - include a checklist to ensure adherence to proper practices;
• Full sterile barrier for providers and patients - use maximal sterile barrier precautions, including the use of a cap, mask, sterile gown, sterile gloves, and a sterile full body drape, for the insertion of CVCs, PICCs, or guidewire exchange. Use a sterile sleeve to protect pulmonary artery catheters during insertion.
• Insertion training for all providers.

Maintenance

• Perform daily assessments of need for line and remove when no longer needed.

• Daily discussion of line necessity, functionality and utilization including bedside and medical care team members.
• Discuss with the medical team continued necessity of line.
• Discuss with the medical team the function of the line and any problems.
• Discuss  with the medical team the frequency  of access and utilization of line. Consider bundling labs and line entries.
• Consider best practice is documentation that the discussion occurred in the medical record.

• Regular assessment of dressing to assure clean/dry/occlusive:

• Replace catheter site dressing if the dressing becomes damp, loosened, or visibly soiled.
• Replace  dressings  used  on  short-term  central  venous  catheters  sites  according  to  CDC  or institution’s protocol.

• Daily CHG bathing and linen changes - Follow manufacturer recommendations for usage
• Perform weekly rounds.
• Send monthly data to team and leadership.

• Celebrate success
• Perform  in-depth  case  reviews  in  instances  where  infections  do  occur  (identify  the  risk(s)  that could’ve been avoided and modifications needed moving forward, if any).
• Utilize a systematic approach to review all hospital acquired CLABSIs

Standardized Access Procedure 17

• Refer to Hand Hygiene details in APSS #2A.
• Disinfect cap before all line entries by scrubbing with an appropriate antiseptic and accessing the port only with sterile devices.
• Scrub the Hub: Alcohol (15 second scrub + 15 second dry) or CHG (30 second scrub + 30 second dry).
• Standardized dressing, cap and tubing change procedures/timing:

• Scrub skin around site with CHG for 30 seconds (2 minute for femoral site), followed by complete drying. (Note: there may be institutional preference for CHG use for infant < 2 months of age).

• Change crystalloid tubing no more frequently than every 72 hours.
• Change  tubing  used  to  administer  blood  products  every  24  hours  or  more  frequently  per  institutional standard.
• Change tubing used for lipid and TPN infusions every 24 hours.
• Document date dressing/cap/tubing was changed or is due for change.
• Consider  when  hub  of  catheter  or  insertion  site  are  exposed,  wear  a  mask  (all  providers  and  assistants) shield patient’s face, ETT or trach with mask or drape.

In the Neonatal ICU:\cite{Miller_2010},\cite{Wheeler_2011},\cite{Milstone_2013},\cite{00030}

• A monthly report-out at team/quality committee and leadership meetings.
• Implement standardized central venous catheter (CVC) practices:

• Insertion checklist
• Daily assessment
• Electronic health record prompt to remove catheter based on feeding volume
• 24-hour catheter tubing change, experienced nurses only
• Enhanced nursing education and competency for CVC care

Education

• Nursing education – care and maintenance bundle
• Neonatal ICU nursing education – enhanced and competency for CVC care
• Central Line Simulation Program

• Develop education for attendings, residents, nurses
• Key Curriculum Concepts – reinforcement

• Hand hygiene
• Appropriate gowning and gloving

• Key Curriculum Concepts – new

• Standardized central line insertion best practice

• Ultrasound guided cannulation

• Updated insertion checklist

• Maintaining sterile technique – immediate feedback

• Central Line Navigator documentation

• General Medical Education

• MD rounding navigators (removal prompt)
• Resident infection prevention training

• Evidence-based practice adherence
• Remain current with new literature findings, e.g., “Guidelines for the Prevention of Intravascular Catheter-Related Infections” 2011 compendium by the CDC \cite{Miller_2010}.
• Patient education document (Figure 1).

Executive Summary Checklist

• 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 pharmacist

The Performance Gap

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:
• Afebrile
• Stable heart rate
• Stable respiratory rate
• Systolic blood pressure >90mm Hg
• O2 saturation >90% (O2 partial pressure >60 mm Hg)
• Functional GI
• Normal mental status
• Dosage 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 analysis
• Rationale: 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 Contribution

• Providing 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 Plan

• Financial support
• Formal statements supporting the ASP and optimal use of antimicrobials within the hospital
• Protected/acknowledged time for personnel from various departments to participate in the ASP.
• Provide training and support to personnel
• Provision of necessary infrastructure for tracking and measuring antimicrobial use and outcomes.

Practice Plan

• Commitment from institutional leadership (technology, personnel, finance)
• Accountability of ASP chair or co-chairs
• A 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 patterns
• Reporting of and education about ASP findings to hospital staff (physicians, nurses, pharmacists, etc.)

Technology Plan

Executive Summary Checklist

• Hospital governance and senior  administrative leadership must champion efforts to raise awareness of the high  incidence of CAUTIs and prevention measures.
• Healthcare leadership must support  the design and implementation of standards and training programs on catheter  insertion and manipulation.

• Insert catheters only for  appropriate indications
• Ensure that only properly trained  persons insert and maintain catheters
• Insert catheters using aseptic  technique and sterile equipment
• Maintain unobstructed urine flow
• Perform  perineal care routinely for patients who have indwelling catheters to reduce  the risk of skin breakdown and irritation
• Remove catheters as soon as possible

• Following aseptic insertion,  maintain a closed drainage system
• Senior leadership must address  barriers, provide resources (budget/personnel), and assign accountability  throughout the organization.
• Select technology has shown early  success to reduce infections and/or positively enhance outcomes of patients and  providers in frontline CAUTI  prevention.

The Performance Gap

Core  Prevention Measures include:

• Insert catheters only for  appropriate indications
• Compliance  with evidence-based guidelines e.g. Surgical Care Improvement Project (SCIP-Inf-9) requires  urinary catheter removal on Postoperative Day 1 (POD1) or Postoperative Day 2  (POD 2) with day of surgery being day zero
• Leave catheters in-place only as  long as needed
• Only properly trained persons insert  and maintain catheters
• Insert catheters using aseptic  technique and sterile equipment
• Maintain a closed drainage system
• Maintain unobstructed urine flow
• Hand hygiene and standard (or  appropriate) isolation precautions       

• Alternatives to indwelling urinary catheterizations
• Portable ultrasound devices to reduce unnecessary catheterizations

• Complex urinary drainage systems
• Changing catheters or drainage bags  at routine, fixed intervals
• Routine antimicrobial prophylaxis
• Cleaning of periurethral area with  antiseptics while catheter is in place
• Irrigation of bladder with  antimicrobials
• Instillation of antiseptic or  antimicrobial solutions into drainage bags
• Routine screening for asymptomatic  bacteriuria (ASB)

Leadership Plan

• Hospital governance and senior  administrative leadership must champion efforts in raising awareness around the  high incidence of CAUTIs and prevention measures.
• Healthcare leadership should support  the design and implementation of standards and training programs on catheter insertion  and manipulation
• Senior leadership will need to  address barriers, provide resources (budget/personnel), and assign  accountability throughout the organization
• Leadership commitment and action are  required at all levels for successful process improvement

Practice Plan

• Reduce the use and duration of use  of urinary catheters

• While there have been multiple  attempts to deploy antimicrobial catheters to reduce the rate of infection,  there is no literature to support that this technology has made a significant  impact.
• It has been estimated that 80% of  hospital-acquired UTIs are directly attributable to use of an indwelling  urethral catheter \cite{15175612} and studies have shown that there is a very high utilization in patients where  it was not indicated or for durations that may have been longer than clinically  necessary \cite{saint2000physicians}.
• Thus the greatest opportunities to  reduce the rate of UTI are 1) to place catheters only for appropriate  indications and 2) to limit the duration of catheter placement.

Technology Plan

• BARDEX® I.C. Advance Complete Care®  Trays

Metrics

Topic:

Outcome Measure Formula

Metric Recommendations

Executive Summary Checklist

• Hospital governance and senior administrative leadership must champion efforts in raising awareness to prevent and safely manage CDI
• Implementation of antimicrobial stewardship programs can prevent and/or minimize infection rates in healthcare settings. Refer to APSS #3A.
• Maintain contact precautions for duration of diarrhea
• Comply with hand hygiene as described in APSS #2A
• Clean and disinfect equipment and environment  Equipment such as blood pressure cuffs and pulse oximeters are frequently not cleaned between patients. Might be useful to include some examples of equipment to ensure routine cleaning.
• Use a laboratory-based alert system for immediate notification of positive test results
• Implement technologies that support proper surface cleaning and utilize as part of a defined environmental control best practice program

• Such as Clorox® Healthcare Bleach Germicidal Wipes or Xenex® UV Light Disinfection System.

• Educate healthcare providers, housekeeping, administration, patients and families about CDI
• Encourage continuous process improvement through the implementation of quality process measures and metrics.
• All CDIs should have a root cause analysis (RCA) completed by the unit where the infection occurred with multidisciplinary participation including nursing, physicians and infection prevention specialists. All learnings from the RCA should be implemented.

The Performance Gap

• Clostridium difficile colonization

• Patient exhibits NO clinical symptoms
• Patient tests positive for Clostridium difficile organism and/or its toxin
• More common than Clostridium difficile infection

• Clostridium difficile infection

• Patient exhibits clinical symptoms
• Patient tests positive for the C. diff organism and/or its toxin

Leadership Plan

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

Practice Plan

• Surveillance

• Implement  a  facility-wide  CDI  surveillance  method  of  both  process  measures  and  the  infection rates to which the processes are linked.

• Hand Hygiene \cite{Oughton_2009}-\cite{00017}

• It  is  recommended  that  healthcare  providers  wash  hands  with  soap  and  water  before  donning gloves  and  following  glove  removal  when  caring  for  patients with  CDI.  No  agent,  including alcohol-based hand rubs, is effective against C. diff spores.
• Appropriate  use  and  removal  of  gloves  is  essential  when  caring  for  patients  with  diarrheal illnesses, like CDI.

• Contact/Isolation Precautions

• Use Standard Precautions for all patients, regardless of diagnosis.
• Place patients with CDI on Contact Precautions in private rooms when available.
• Perform hand hygiene and put on gown and gloves before entry to the patient’s room.
• Use dedicated equipment (blood pressure cuff, thermometer, and stethoscope).
• Remove gown and gloves and perform hand hygiene before exiting the room.
• Educate  the  patient  and  family  about  precautions  and  why  they  are  necessary  and  ensure  that visitors are properly attired in personal protective equipment.

• Environmental Infection Prevention

• Use EPA-approved germicide for routine disinfection during non-outbreak situations \cite{00019}.
• Ensure that personnel allow appropriate germicide contact time.
• Ensure   that   personnel   responsible   for   environmental   cleaning   and   disinfection   have   been appropriately trained.
• For routine daily cleaning of all patient rooms, address at least the following items:

• Bed,  including  bedrails  and  patient  furniture  (including  the  bedside  and  over-the-bed tables and chairs).
• Bedside commodes and bathrooms, including sink, floor, tub/shower, toilet.
• High-touch surfaces like call buttons and TV remotes.
• Communication  devices  such  as  walkie-talkies  used  by  nurses  to  communicate  with  the nursing station as well as personal cell phones carried by healthcare personnel.

• Antimicrobial Stewardship and CDI

• Implement a program that supports the judicious use of antimicrobial agents \cite{00020}.
• The  program  should  incorporate  a  process  that  monitors and  evaluates  antimicrobial  use  and provides feedback to medical staff and facility leadership.

Technology Plan

• Implement technologies that support proper surface cleaning and utilize as part of a defined environmental control best practice program

• Such as Clorox® Healthcare Bleach Germicidal Wipes or Xenex® UV Light Disinfection System.

• Implement technologies that support proper hand hygiene and utilize as part of a defined hand hygiene best practice program such as product utilization and staff movement tracking, sensor bracelets, alcohol sensing technologies.

• See APSS 2A for a list of hand hygiene technology suppliers

Metrics

Topic:

Outcome Measure Formula:

Metric Recommendations:

Executive Summary Checklist

• Hospital governance and senior administrative  leadership must champion efforts to raise awareness of the problem in their own  institution, in order to prevent and safely manage SSIs.
• Educate patients and families on SSI prevention.
• Implement surveillance and metrics to measure patient  outcomes.  The results of this monitoring  should be reviewed at periodic caregiver education sessions, such as “grand  rounds.” 

Pre-operative:

• Administer antimicrobial prophylaxis in accordance with  evidence-based standards and guidelines \cite{23461695}.

• Administer within 1 hour prior to incision (2 hours for  vancomycin and fluoroquinolones)
• Select appropriate agents on basis of:

1.      Surgical Procedure

2.      Most common SSI pathogens for the planned procedure

3.      Known allergies or drug reactions of each specific  patient.

4.      Published recommendations

• Do not remove hair at the operative site unless it will  interfere with the operation.
• Use appropriate antiseptic agent and technique for skin  preparation, preferably an alcohol containing preparation \cite{27915053,28467526}
• If appropriate,  mechanically prepare patients for colorectal surgery by enema or cathartic  agents. Administer non-absorbable oral antimicrobial agents in divided doses on  the day before the operation \cite{27915053}
• Smoking cessation 4 to 6 weeks before surgery \cite{27915053}

Intraoperative: 

• Implement 
• Maintain intraoperative and immediate postoperative normothermia \cite{27915053}
• Re-dose prophylactic antibiotics based on agent half-life or for every 1,500 mL blood loss \cite{27915053}
• Keep operating room (OR) doors closed during surgery  except as needed for passage of equipment, personnel, and the patient.  Ensure that interior of operating room is at  “positive pressure” relative to adjacent corridors. 
• Use of an impervious plastic wound protector can prevent SSI in open abdominal surgery, particularly colorectal and biliary procedures \cite{27915053}
• Triclosan antibacterial suture use is recommended for wound closure in clean and clean-contaminated abdominal cases when available \cite{27915053}
• Change gloves before closure in colorectal cases \cite{27915053} 
• Topical irrigation of the incision site, particularly in colorectal surgery \cite{25681239}

Postoperative:

• Protect primary closure incisions with sterile dressing  for 24-48 hours post-op
• Supplemental oxygen (80%) is recommend in the immediate post-operative period \cite{27915053}
• Discontinue antibiotics within 24 hours after the  surgery end time (48 hours for cardiac patients), unless signs of infection are  present.

The Performance Gap

Leadership Plan

• Hospital governance and senior administrative leadership must champion efforts in raising awareness around the high incidence of SSIs and prevention measures.
• Healthcare leadership should support the implementation of standards on pre-, intra- and postoperative guidelines to minimize incidence of SSIs.
• Senior leadership will need to address barriers, provide resources, and assign accountability throughout the organization
• Hospital administration should implement surveillance and metrics to measure outcomes.

Practice Plan

• Pre-operative skin cleansing

• Develop standardized process for pre-operative skin cleansing that includes the repeated use of chlorhexidine gluconate (CHG).
• Educate patients on how to appropriately apply the CHG prior to surgery, and about the risk that they might reduce the residual beneficial effects of the CHG if they apply lotions or deodorants after cleansing.

• Pre-operative screening for patients at risk for SSI

• Develop a protocol to conduct nasal Staphylococcus aureus (SA) screening in patients undergoing cardiac and elective orthopedic surgery.
• Develop a protocol to attempt to decolonize SA carriers that includes intranasal Mupirocin.

• Educate patients and families on SSI prevention

• The adverse effect of tobacco use on wound healing and the importance of ceasing tobacco use for a minimum of 1 month pre- and post-surgery.
• Importance of proper nutrition pre- and post-operatively to support competent immune response to infection.
• In patients with diabetes, the importance of ensuring their blood sugar is well controlled.
• Appropriate preoperative bathing and skin cleansing.
• Identify any skin irritation or hypersensitivity in prior surgical experiences, and any new skin conditions.
• Postoperative wound handling techniques and hand hygiene.
• Early signs of sepsis

• Peri-operative skin antisepsis

• Use preoperative skin antiseptic agents that have been FDA-approved or -cleared and approved by the health care organization’s infection control personnel; these should be used for all preoperative skin preparation. This preparation should significantly reduce microorganisms on intact skin, contain a non irritating antimicrobial preparation, be broad spectrum, be fast acting, and have a persistent effect.
• Develop standardized practices, guided by the product insert, for the peri-operative application of skin antiseptic agents that ensures an appropriate therapeutic dose covers and is maintained across the entirety of the skin surface.
• Educate perioperative personnel on the safe application and use of selected skin antiseptic agents, and the benefits of skin antisepsis to reduce the microbial burden on the skin prior to surgery.

• Proper hair removal

• Remove only hair that interferes with the surgical procedure.
• Clip hair at the surgical site using a single-use hair clipper, or with a clipper with removable head that can be disinfected between patients. Razors should not be used.

• Appropriate timing, selection, and duration of prophylactic antibiotics
• Glycemic control

• Implement perio-operative glucose control, targeting blood glucose levels <200 mg/dL

• Maintenance of normothermia

• Use warmed forced-air blankets preoperatively, during surgery, and in PACU.
• Use warmed fluids for IVs and flushes in surgical sites and openings.

Technology Plan

• Consider implementing technologies that actively clean and remove infectious contamination from the surgical incision such as:

• CleanCision^TM Wound Retraction and Protection System \cite{28846497}

• Consider implementing technologies that provide skin antiseptic activity such as:

• 3M® Duraprep™ and Carefusion® Chloraprep™

• Consider implementing technologies that support intraoperative wound protection such as:

• Applied Medical® Alexis™ and 3M® SteriDrape™

Metrics

Topic

Metric Recommendations

Data Collection: