Sepsis in the NICU and Interventions to Improve Care Joseph El Khoury, MD Children s Hospital of Richmond at VCU Virginia Neonatal Perinatal Collaborative Meeting May 12 th, 2017
Significance of Sepsis in the NICU Neonatal sepsis, especially hospital acquired sepsis, is a major healthcare concern High mortality High morbidity Extended length of stay A lot of stress on Neonatologists/NNP/RNs Early-Onset Neonatal Sepsis: A Continuing Problem in Need of Novel Prevention Strategies. Stoll, B. J. PEDIATRICS, 12/01/2016, Vol.138(6)
Very Low Birth Weight a Risk Factor Rates of infection, morbidity and mortality continue to be highest among preterm infants Especially very low birth weight infants (1) Virtually all very low birthweight (VLBW) and roughly half of term infants require intensive care for respiratory support and/or blood pressure support (2) 1. Stoll et al. Early-Onset Neonatal Sepsis: A Continuing Problem in Need of Novel Prevention Strategies. PEDIATRICS, 12/01/2016, Vol.138(6) 2. Stoll BJ, Hansen NI, Sánchez PJ, et al: Early onset neonatal sepsis: The burden of group B streptococcal and E. coli disease continues. Pediatrics 127:817-826, 2011
Mortality Rate from Sepsis is high Ages 1-3 days of life (n=104,676) Early onset sepsis 1% Early onset sepsis mortality 25.9% (vs 11.3%) Ages 4-120 days of life (n=99,796) Late onset sepsis 12.2% Late onset mortality 15.1% (vs 8.5%) Hornik CP. Mortality: Early Onset Sepsis (EOS) & Late Onset Sepsis (LOS). Early Human Dev 2012;88(S2):s69. r Very Low Birth Weight ( < 1500 grams) Infants
Challenges with Neonates Not all newborns exhibit symptoms when septic Premature and ill neonates often present with nonspecific and subtle signs that delay identification and early treatment Experience is key One study of infants born 37 weeks found bacteremia in 0.5% of evaluated asymptomatic infants versus 3.2% of evaluated symptomatic infants (1) 1. Johnson CE, Whitwell JK, Pethe K, et al: Term newborns who are at risk for sepsis: Are lumbar punctures necessary? Pediatrics 99:e10-e14, 1997
Underdeveloped Immune System Neonates have a compromised immune system Neutrophils in neonates: Are less able to move into tissue Have deficient killing capacity Are quickly depleted in critically ill neonates Are not replenished quickly enough due to immature bone marrow Neonates have decreased levels of immunoglobulins
To Treat or not to Treat The majority of Neonatologists would vote treat Current practices are to shoot and ask questions later High suspicion for sepsis Evaluate any signs and symptoms that deviate from baseline Low threshold for obtaining cultures and starting antibiotics Also generally agreed upon is that early treatment is better and safer than late treatment
Challenges with Sepsis Many challenges are present when initiating sepsis workups IV access Limited sites for access Inexperienced staff Poor perfusion Obtaining cultures Blood Urine CSF Unstable patients Obtaining consent
Importance of Intervention Prior to the CDC putting out guidelines recommending the use of intrapartum antibiotic prophylaxis (IAP) to prevent perinatal GBS infections Incidence of EOS in the United States was 3-4 cases/1000 live births After the guidelines were put out the rate of GBS-specific EOS declined to 0.3-0.4 cases/1000 live births Overall, EOS incidence declined to 0.8-1.0 cases/1000 live births Risk Assessment in Neonatal Early Onset Sepsis Mukhopadhyay, Sagori ; Puopolo, Karen M. Seminars in Perinatology, December 2012, Vol.36(6), pp.408-415
Timing is Important Cultures don t Heal the Baby, Antibiotics do When sepsis is suspected, treatment must be immediate due to both the immunosuppression and non-specific signs Antibiotics should be started as soon as diagnostics tests are performed Timing of antibiotics is not researched a lot in Neonatology Most of the studies are in pediatrics and adults R. Moores, MD Do not take into account the less effective immune system of the neonate There is a lot of emphasis on not just when to initiate antibiotics, but also the timing between initiation of the sepsis work up and the timing of antibiotic administration
Qualitiy Improvement at VCU
Committee to Improve Care In 2012, a sepsis committee composed of RNs, MD, NNPs and Pham D started looking at our timing of antibiotic administration Aspects of quality improvement were identified Goals: Improve timing of antibiotic administration Patients to receive antibiotics within 2 hours of diagnosis of sepsis
Pilot Study Showed a Major Concern In 2012, a pilot study done by Sheila Pedigo (Pharm D) revealed that antibiotics were given anywhere between 3-5 hours from the time an order was placed Antibiotic Average time from Range order to administration Ampicillin (N=26) 3.9 hr 0.5-8.5 hr Gentamicin (N=28) 4.6 hr 1.5-15 hr (EOS) Gentamicin (N=22) 3.8 hr 0.5-12 hr (LOS) Vancomycin (N=28) 3.4 hr 0.5-7 hr To note this is pharmacy data and not data collected in the NICU
Approach Used Identify steps and time involved for individual components regarding workup and treatment of neonatal sepsis Evaluate data for barriers, if any, which delay expedient therapy for sepsis by medical staff, nursing, and pharmacy staff
Identifying Steps in Process for EOS Treatment Initiation Was the unit aware of the pending delivery? Yes No Time Aware? Baby was born: time L&D team left delivery room: time Baby arrived in the NICU: time Time antibiotics ordered? Time antibiotics arrived on unit? Did you receive them immediately after they arrived? Yes No time Blood culture initiated? time Blood culture completed? time Was an LP performed? If yes, Time initiated Time completed Line placement was initiated: Line placement was completed: time IV fluids started: time X-ray ordered: time X-ray completed: time X-ray read: time First antibiotic started: finished time Name of antibiotic: Second antibiotic started: finished time Name of antibiotic: Were there delays in the admission process? Yes No What were the delays? Time Giraffe Top Down if applicable
Identifying Steps in Process for LOS Treatment Initiation Please note the time of these actions when late onset sepsis is suspected What time did physician or NNP first articulate presumed sepsis? time What time was nursing notified? time What time was order for antibiotics placed? time At the time of notification, did the infant have a suitable line for administration of antibiotics? Y/N If not, what time was line initiated? What time was line completed? Barriers to line placement? Time antibiotics arrived on unit? Time at bedside? Did you receive them immediately after they arrived? Yes No Time Blood culture initiated? Time Blood culture completed? Time LP initiated? Time LP completed? Urine culture initiated? Urine culture initiated? time First antibiotic started: finished time Name of Antibiotic ordered: Second antibiotic started: finished time Name of Antibiotic ordered: Were there delays in the septic work-up process or administration of antibiotics?yes No What were the delays?
Pharmacy Aspects Regarding Neonatal Sepsis Effective antimicrobial order verification for dose, dose interval, schedule and product Identify all aspects in the process involved in drug order verification to dispensing Identify barriers, if any, which impact the process involved in drug order verification to dispensing
Findings System wide problem Needed to implement changes on multiple levels
NICU QI Committee Initial Recommendations Diagnostic Aspect If RN not at bedside when decision made to implement sepsis workup, notify them immediately Notify charge nurse and MD/NNP if no IV access obtained within 30 minutes No more than 3 attempts per provider Communicate which antibiotic to be given first Cultures Drawn prior to antibiotic administration if possible MD/NNP should be notified if cultures are not obtained within 30 minutes of initiation
Recommendations Antibiotic administration time target 2 hr for antibiotic administration (ideal goal 1 hour) 1 hr for dispensing from pharmacy (ideal goal 30 minutes) Cultures Culture drawn before antibiotics ideal Drug flush volume 1 ml of normal saline IM antibiotics NOT indicated Revision of current sepsis protocol
Outcomes There was a significant improvement in time between order entry to first dose of antibiotics Early Onset Sepsis: average 2.4 hours (decreased from 4.2 hours) Late Onset Sepsis: average 2.2 hours (decreased from 5.3 hours)
Further Intervention In 2013 Children s Hospital of Richmond at VCU started a Pediatric Sepsis Committee Includes all Pediatrics units (Wards, ED, PICU, NICU) Goals Reduce mortality from sepsis by 10% (Hospitalwide) Time to antibiotics: 70% of stat IV antibiotics have order to delivery time <60 minutes
Changes Implemented in the NICU During that Time Antibiotics were now stored in the PYXIS system on the unit for faster access Only accessed if delay in delivery from pharmacy Antibiotic doses were barcoded and scanned into the system at time of administration Improved accuracy of charting times of administration New Sepsis protocol was now in use
Report of 2016
Improvements Needed Became clear that even though we improved administration time in the QI initiative of 2012, more needed to be done NICU sepsis committee met again and evaluated current processes Findings presented to faculty and leadership in the NICU and new recommendations were suggested
Recommendations Recommendations unofficially implemented as they are not finalized yet include: When sepsis is suspected the charge nurse, patient s nurse, attending, fellow and NP/resident huddle by the patient s bedside to discuss findings and plan Once decision to initiate sepsis work-up is made Attending/fellow/NP stay in the room with the patient until sepsis work-up is completed Makes them readily available for questions, concerns, to help Charge nurse stays and assists the nurse taking care of the patient with obtaining access, blood and urine culture, and getting needed supplies A new form is filled out to document timing of events
Form Filled out by Nursing
Updated Results Through End of January
Updated Results Through End of January
Updated Results Through End of January
Updated Results Through End of February
Updated Results Through End of February
Updated Results Through April
Updated Results Through April
Future plans Recommendations pending implementation as need more discussion and approval If lumbar puncture (LP) consent is not obtained Bypass consent and obtain LP (needs two MDs to sign consent as life threatening) Give antibiotics and obtain LP after If any culture is not obtainable give antibiotics within the hour regardless (attending approval needed) Update current sepsis protocol to include timeline of steps
Lessons Learned There is always room to improve Quality Improvement is never ending Teamwork is very important to achieve goals and improve care Education is very important to achieve goals and improve care
Thank you