Early Human Development 90S2 (2014) S5–S9
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Early Human Development j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / e a r l h u m d ev
Editorial
Quality improvement and initiatives in neonatal intensive care Avroy A. Fanaroff* Eliza Henry Barnes Professor of Neonatology, Rainbow Babies and Children’s Hospital, Professor of Pediatrics, Case Western Reserve University School of Medicine, Cleveland, OH, USA
article info Keywords: Quality improvement Antenatal corticosteroids Prevention of infection Preventing moderate hypothermia Screening for critical congenital heart disease Optimal cord clamping/milking Universal bilirubin screening
1. Introduction and background According to the Department of Health and Human resources in the USA, “Quality Improvement (QI) is not simply an end goal but a continuous process that employs rapid cycles of improvement. The key elements are structure, process and outcome, which is the impact of the care on health status. The Institute of Medicine has six specific aims for improvement. These are safety, effectiveness, patient centered, timely, efficient and equitable. Key elements for the success of quality initiatives are an enthusiastic staff who undergo rigorous education and training and develop a culture of communication and teamwork. Rigorous documentation and feedback to the staff are also important. Flow charts documenting the process and the results are valuable too. The positive feedback when a daily updated chart indicates, for example, no documented infections for the past 88 days draws attention and focus to the task. The neonatal intensive care unit networks which cover regions, states, entire countries and even multiple countries, are the ideal forums platform to implement continuous quality improvement initiatives and improve the outcomes for all neonates. Spearheaded by the Vermont Oxford Network Quality collaborative, quality improvement has gained traction and is an integral part of the standard of care in most tertiary neonatal units. Diverse quality endeavors range from antenatal care, antenatal steroids for preterm deliveries between 23 and 34 weeks gestation, intrapartum administration of antibiotics to Group B streptococcus positive women, intrapartum cord management, delivery room thermal protection to prevent moderate hypothermia, screening for critical congenital heart disease, promotion of human milk feeding, pain management, * E-mail address:
[email protected] (A.A. Fanaroff). 0378-3782/$ – see front matter © 2014 Elsevier Ireland Ltd. All rights reserved.
to algorithms for the management of neonatal jaundice and the very successful programs to prevent central line infections. Quality improvement has become an integral component of neonatal care and is improving outcomes. Here follow some examples of quality improvement initiatives and their achievements. 2. Antenatal corticosteroids Despite clear documentation that antenatal corticosteroids reduced mortality, the severity of respiratory distress syndrome and intra-ventricular hemorrhage, prior to 1995 only 20 percent of preterm deliveries received antenatal corticosteroids. In 1994, following a consensus conference, the National Institutes of Health recommended a full course of antenatal corticosteroids (ACS) to women who were at risk of delivery at 24–32 weeks of gestation [1–3]. In 2010, the Joint Commission on Accreditation of Healthcare Organization incorporated ACS administration rates as a perinatal core quality measure. Despite these guidelines only 80–85% of women delivering at these early gestations receive ACS. Opportunities for systems based improvement in ACS include continuing education, decreasing the time interval from patient evaluation to ACS administration and standardizing outpatient follow-up evaluation for patients who were discharged with symptoms of preterm labor [4]. 3. Intrapartum antibiotics for prevention of group B streptococcal infection Since the early 1970s, group B streptococci (GBS) have been the leading cause of early-onset neonatal sepsis in the United States and many countries worldwide. Pregnant women with GBS colonization are 25 times more likely to deliver an infant with early-onset GBS sepsis than women who are culture negative. Affected infants become colonized/infected during
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labor and delivery and present with respiratory distress or other signs of sepsis in the first 24–48 h of life. In the absence of intrapartum prophylaxis, 2% of infants will develop early-onset GBS sepsis with a significant morbidity and mortality. Initial recommendations for the prevention of early-onset GBS disease permitted either screening cultures or a risk based strategy. Universal screening by culturing all pregnant women at 35–37 weeks’ gestation and treatment of culture-positive women were recommended in 2002. By 2008 this resulted in a dramatic decline in GBS sepsis from 1.7–2/1,000 live births to 0.28/1,000 live births. About 85% of women were being screened for colonization with GBS and more than 80% of colonized women received intrapartum prophylaxis. The guidelines were updated in 2010 [5] with the recommendation that all pregnant women should undergo vaginal-rectal screening for GBS colonization at 35–37 weeks. In addition to women with GBS positive screening, in the current pregnancy intrapartum antibiotic prophylaxis (IAP) is recommended for women who delivered a previous infant with GBS disease, women with GBS bacteriuria and women with unknown GBS status who deliver at less than 37 weeks’ gestation, have an intrapartum temperature of 100.4°F or greater, or have rupture of membranes for 18 hours or longer. remains the preferred agent with ampicillin an acceptable alternative. The key changes in the 2010 guidelines include the following: • expanded recommendations on laboratory methods for the identification of GBS, • clarification of the colony-count threshold required for reporting GBS detected in the urine of pregnant women, • updated algorithms for GBS screening and intrapartum chemoprophylaxis for women with preterm labor or preterm premature rupture of membranes, • a change in the recommended dose of penicillin-G for chemoprophylaxis, • updated prophylaxis regimens for women with penicillin allergy, and • a revised algorithm for management of newborns with respect to risk for early-onset GBS disease.
This has resulted in a 25% decrease in EOS evaluations performed among well-appearing infants ≥36 weeks’ gestation [6]. In summary, although early-onset GBS disease has been significantly reduced, the rates of maternal GBS colonization (and therefore the risk for early-onset GBS disease in the absence of intrapartum antibiotic prophylaxis) remain unchanged since the 1970s. Over the past 25 years, the case death rate has fallen from 25–50% to 4–6%. Some of the cases relate to lack of screening, others to preterm delivery prior to screening which is done at 35 weeks, and a residual number of cases to false negative screens. The goal is to reduce these cases and case fatalities even further. Until a GBS vaccine is developed universal screening and intrapartum antibiotics remain the gold standard. It is worth noting the critical conclusions from Ohlsson and Shah in their Cochrane review: Intrapartum antibiotic prophylaxis appeared to reduce Early Onset GBS Disease (EOGBSD), but this result may well be a result of bias as we found a high risk of bias for one or more key domains in the study methodology and execution. There is lack of evidence from well designed and conducted trials to recommend IAP to reduce neonatal EOGBSD. Ideally the effectiveness of IAP to reduce neonatal GBS infections should be studied in adequately sized double-blind controlled trials. The opportunity to conduct such trials has likely been lost, as practice guidelines (albeit without good evidence) have been introduced in many jurisdictions. Ohlsson and Shah (2014) [7]
I concur that the opportunity to do such trials has been lost [8].
4. Optimal cord clamping It has been suggested that immediate clamping of the cord was implemented in the USA to prevent severe hyperbilirubinemia. If that was indeed the case the practice has deprived millions of newborn babies of their rightful transfusion at birth. Fortunately that trend is finally being reversed as the perinatal community comes to its senses and examines the ever accumulating evidence demonstrating the benefits of delaying cord clamping by 30–60 seconds or more, or milking a long segment of an early clamped cord. The new practice has been endorsed by the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics (AAP) and the World Health Organization (WHO) as well as other societies. In term infants, data strongly support the benefits of delayed cord clamping, especially in the developing world, where iron deficiency is so prevalent. A brief delay in clamping the umbilical cord after birth offers health benefits to the newborn, with no adverse effects to the mother or her infant. In term infants, umbilical cord clamping between 30 and 180 s after birth results in higher concentrations of hemoglobin and hematocrit during the neonatal period, and increased serum ferritin levels and a lower incidence of iron-deficiency anemia at 4–6 months of age [9]. This translates too into higher I.Q. somewhere in the order of 5 points which on a population basis is tremendous. In preterm infants, delayed cord clamping for at least 30 s or cord milking increases the concentrations of hemoglobin and hematocrit, stabilizes blood pressure, increases urine output, and enhances cardiac function [10–12]. All this is associated with a diminished need for vasopressors and blood transfusions during the neonatal period. Neonates receiving umbilical cord milking required fewer days on oxygen therapy, and less frequent use of oxygen at 36 weeks’ corrected postmenstrual age in addition to a decreased prevalence of intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC) and sepsis [13,14]. There may be an increased need for phototherapy but bilirubin levels are usually only marginally higher in the late clamped group. In summary, both delayed cord clamping and umbilical cord milking are associated with lower rates of serious morbidity in low birth weight infants. Recommendations from the American College of Obstetricians and Gynecologists are for a 1-minute delay for preterm infants “when feasible”. The optimal umbilical cord clamping practice among neonates requiring immediate resuscitation remains uncertain. More data are needed on the long term outcomes related to these practices. 5. Avoiding moderate hypothermia Despite recommendations from the Neonatal Resuscitation program and the WHO to maintain the temperature in the delivery room (DR) at 25.1°C, this recommendation is largely ignored. In developed countries the priority has been the comfort of the mother and medical staff rather than the critically important thermal environment of the preterm infant. This practice is intellectually justified by the assumption that the newborn’s thermal needs will be met by a radiant warmer or incubator together with the immediate use of warmer pads or plastic bags. Preterm infants are susceptible to hypothermia shortly after birth. Laptook et al. found that 47% of 5277 very low birth weight (VLBW) infants had a body temperature <36°C on admission to the neonatal intensive care unit (NICU) [15]. Adjusted analyses showed that admission temperature was inversely related to mortality, with a 28% increase in
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mortality per 1°C decrease in body temperature. Setting a goal and implementing a thermoregulation bundle in order to accomplish normothermia during resuscitation, stabilization and admission into the NICU can dramatically decrease mortality and morbidity, and yields substantial economic benefits. An initial goal would be to ensure ≥90% admission temperatures above 36°C without increasing hyperthermia rates. DeMauro and colleagues [16] developed evidence-based guidelines to prevent heat loss, reduce exposure to supplemental oxygen, and increase use of noninvasive respiratory support to improve the care and outcomes of infants with birth weight ≤1250 g. They developed a team structure with ongoing education and feedback to the staff that were committed to the process. The outcomes were spectacularly good. Not only were fewer babies admitted with moderate hypothermia (1% versus 14% prior to the Q.I. initiative), but the duration of exposure to oxygen in the first ten minutes was reduced, as were the duration of intubation and length of hospital stay. Length of hospital stay was reduced 20 days, an enormous cost saving for a series of simple interventions. An integral part of the therapy was to warm the dedicated resuscitation area to 76–77 degrees F. The authors emphasized the roles of multidisciplinary involvement and continuous education in sustaining the change. Furthermore maintaining visible documentation for the staff of their accomplishments reinforces the importance of the project and gives them positive reinforcement. Pinheiro and colleagues [17] similarly developed a thermoregulation bundle which resulted in a sustained decrease in the number of hypothermic babies admitted to the NICU without increasing the number of hyperthermic babies (>37.5°C, F = 2.5%). De Almeida et al. [18] reinforced the concept, documenting that simple interventions, such as maintaining DR temperature >25°C (77°F), reducing maternal hypothermia prior to delivery, providing plastic bags/wraps and caps for the newly born infants, and using warm resuscitation gases, decrease hypothermia at NICU admission and improve early neonatal survival. Mathew et al. [19] reported that vinyl bags and warming mattress are equally effective in improving admission temperature in extremely low gestational age neonates (findings confirmed by Russo et al. [20] and Godfrey et al. [21]). Overall Q.I. projects related to neonatal hypothermia are inexpensive yet supremely cost effective. 6. Screening for critical congenital heart disease Screening for critical congenital heart disease (CCHD) lends itself well to quality improvement initiatives. Congenital heart defects affect approximately 1% of live births, of which 25% are estimated to be critical and require surgery or catheterization within the first year of life. Once it had been established that screening for congenital heart defects by means of antenatal ultrasonography and postnatal clinical examination missed and delayed diagnosis in too many cases, screening by means of pulse oximetry gained traction. All agree that the detection of life-threatening, critical congenital heart defects (CCHDs) during the first 3 days of life, before they die or present with acute cardiovascular collapse, is an urgent priority. Pulse oximetry screening has therefore been mandated by the Surgeon General in the USA. Pulse oximetry has proven to be safe, sensitive and specific. The false positive rate is <1% so that unnecessary echocardiography and family anxiety are held to a minimum. Indeed, many of the so-called false positives have proven to have other illnesses that require attention and could easily have been missed. Ewer [22], one of the early proponents
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of screening for CCHD, has written a position paper entitled “Pulse oximetry screening for critical congenital heart defects in newborn infants: Should it be routine?” He acknowledges that pulse oximetry screening is not a perfect test, with a sensitivity of around 75% for CCHD [23], but is of the strong opinion that in combination with other routine screening procedures the vast majority will be identified. He concludes “Given the simplicity of the test and underlying principles, it is hard to argue against routine pulse oximetry screening.” I find no argument with his logic and am very supportive of the concept. Implementation in the USA is occurring at a good pace. Ewer has also described a good business model justifying screening which is a very useful document for those introducing screening programs [24]. Peterson et al. [25,26] have carefully examined the potential benefits of screening. They estimated that almost 30% of cases with non-syndromic CCHD in the National Birth Defects Prevention Study might have benefited from routine CCHD screening at birth hospitals as their diagnoses were delayed by at least three days. The underlying heart disease obviously affected the rate and coarctation of the aorta is the easiest diagnosis to miss. It may be easy to mandate screening, but implementation presents a number of challenges. In Minnesota, a state with sophisticated health care and providers, 91 of 99 eligible centers participated in a survey and 90 reported the ability to screen newborns in accordance with recommendations [27]. However only 22 centers, with 63% of births, had access to echocardiography and routinely stocked prostaglandins for neonatal use. In their pilot study of 7549 newborns who were screened, 6 failed screens and there was one CCHD diagnosis. Two of the failed screens were due to misinterpretation of the algorithm, 1 failed screen was not reported, and 4 failed screens were not recognized. Repeated screens were required for 115 newborns, with 29% of retesting due to misinterpretation of the algorithm. The mean nursing time required was 5.5 minutes, and the cost was $5.10 per screen. Bottom line, there is much learning and teaching yet to be done before we have universal screening in the USA. They suggested a central reporting mechanism. The above comments relate to screening for CCHD at sea level. What about moderate and high altitude? Well you might guess that the number of false positives would be higher, because normal saturations at altitude would be lower and more variable. You would be correct. Wright et al. [28] reported a higher failure rate for CCHD screening at altitude when using sea-level guidelines and pleaded for studies at moderate and high altitudes to develop the appropriate, adjusted screening protocols. They were of the opinion that the increased false positives placed an unnecessary burden on families, communities and health resources. Screening for CCHD is still in the early phases but the long term expectations are that many lives will be saved by earlier detection. Computer applications to aid the testers with interpretation of the findings will no doubt be developed in the near future. 7. Preventing central line-associated bloodstream infections On the one hand the use of central venous catheters has permitted lifesaving treatment for critically ill neonates; on the other, however, the attributable mortality rate for central lineassociated bloodstream infections (CLABSIs) has been estimated to be between 4% and 20%. For many years the thinking was that nosocomial infections, notably those associated with
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central lines, were an inevitable and unavoidable part of neonatal intensive care. Due mainly to the application of quality improvement science the thinking is that infections can be totally prevented and each infection represents a breakdown by the team. The so called CLABSI bundles have resulted in dramatic declines in central line and late onset infections. These include a comprehensive catheter-related staff education, sterile surgicallike preparation and dress for line placements; standardization of skin preparation, introduction of new antiseptic agents, implementation of central catheter insertion and maintenance checklists, reinforcement of the use of maximal sterile barrier precautions, and revision of the central catheter configuration and maintenance protocols including minimal invasion of the line and care of the hubs. A unit in Canada documented a decline in the CLABSI rate from 7.9 per 1000 catheter days at the beginning of the study (August 2007 to June 2008) to 2.2 per 1000 catheter days (May 2010 to March 2011). They noted “Continuous quality improvement measures are required to reduce catheter-related bloodstream infections among lowbirth-weight infants.” [29]. Dioni et al.’s recipe to reduce the incidence of infections includes similar components [30]. They mandated “adequate staff and resources to provide education, training, and quality improvement programs, within a culture of communication and teamwork”. Rigorous reporting schedule on line care and the implementation of unique bundle elements, the use of health care failure mode and effect analysis, the judicious use of antibiotics through an antimicrobial stewardship strategy, the application of specific antifungal prophylaxis are among the most effective, while the addition of heparin to parenteral solution, or interventions with the use of antibiotic plus heparin lock therapy are under evaluation. Nursing assistance plays a fundamental role in managing central venous lines and in reducing or preventing the incidence of infection. These processes have been applied on a state-wide basis in a number of states in the USA with equal success. In Ohio for example there was a 20% reduction in late onset sepsis with the introduction of a quality improvement collaborative. The authors concluded that this was less than anticipated because there was less than ninety percent compliance with the care of the catheters [31]. Similar results have been observed internationally wherever they have been applied. 8. Conclusion In summary, quality improvement initiatives are now an integral part of care in the Neonatal Intensive care units. International collaborative initiatives are gathering data to implement the best care practices to obtain the best outcomes for their patients [32,33]. All aspects of neonatal care can be subjected to quality improvement protocols and bundles.
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