Evolution of the American College of Surgeons Children's Surgery Verification Program: Implications for optimizing multidisciplinary surgical care of the pediatric patient.

The Children's Surgery Verification Program of the American College of Surgeons began in 2016 based on the standards created by the Task Force for Children's Surgery. This program seeks to improve the surgical care of children by assuring the appropriate resources and robust performance improvement programs at participating centers. Three levels of centers with defined scopes of practice and matching resources are defined. Since its inception more than 50 center have been verified. A specialty hospital program was launched in 2019. The standards for all hospitals were revised in 2021 based on lessons learned. In this article the leaders of the program discuss the development, areas of greatest impact and future directions of the program.

Pediatric Perioperative Cardiac Arrest, Death in the Off Hours: A Report From Wake Up Safe, The Pediatric Quality Improvement Initiative.

BACKGROUND: Pediatric perioperative cardiac arrest (CA) is a rare but catastrophic event. This case-control study aims to analyze the causes, incidence, and outcomes of all pediatric CA reported to Wake Up Safe. Factors associated with CA and mortality after arrest are examined and possible strategies for improving outcomes are considered. METHODS: CA in children was identified from the Wake Up Safe Pediatric Anesthesia Quality Improvement Initiative, a multicenter registry of adverse events in pediatric anesthesia. Incidence, demographics, underlying conditions, causes of CA, and outcomes were extracted. Descriptive statistics and logistic regression were used to study the above factors associated with CA and mortality after CA. RESULTS: A total of 531 cases of CA occurred during 1,006,685 anesthetics. CA was associated with age (odds ratio [95% confidence interval] comparing ≥6 vs <6 months of 0.26 [0.22-0.32]; P = .014), American Society of Anesthesiologists physical status (ASA PS III-V versus I-II, 9.24, 7.23-11.8; P < .001), and emergency status (3.55, 2.88-4.37; P < .001). Higher ASA PS was associated with increased mortality (ASA PS III-V versus I-II, 3.25, 1.20-8.81; P = .02) but anesthesia-related arrests were correlated with lower mortality (0.44, 0.26-0.74; P = .002). ASA emergency status (1.83, 1.05-3.19; P = .03) and off hours (night and weekend versus weekday, 2.17, 1.22-3.86; P = .008) were other factors associated with mortality after CA. CONCLUSIONS: The Wake Up Safe data validate single-institution studies' findings regarding incidence, factors associated with arrest, and outcomes of pediatric perioperative CA. However, CA occurring during the off hours had significantly worse outcomes, independent of patient physical status or emergency surgery. This suggests an opportunity for improved outcomes.

American College of Surgeons Children's Surgery Verification Quality Improvement Program: What Anesthesiologists Need to Know Now.

A task force of pediatric surgical specialists with the support of The American College of Surgeons recently launched a verification program for pediatric surgery, the Children's Surgery Verification quality improvement program, with the goal of improving pediatric surgical, procedural, and perioperative care. Included in this program are specific standards for the delivery of pediatric anesthesia care across a variety of practice settings. We review the background, available evidence, requirements for verification, and verification process and its implications for the practice of pediatric anesthesia across the country. In addition, we have included a special roundtable interview of 3 recently Children's Surgery Verification-verified program directors to provide an up-to-date real-world perspective of this children's surgery quality improvement program.

Nursing perception of risk in common nursing practice situations.

As health care organizations seek to be highly reliable, systems that include layers of redundancy have been created to protect patients from harm. Many of these layers of protection are dependent on nurses making a decision to follow or adhere to the human aspects of the process. Because these decisions begin with a perception and identification of risk, understanding what nurses perceive to be a risk to patients is an essential part of designing safer health care systems. The purposes of this qualitative study were to (1) describe what nurses perceive as risky to patients in common nursing practice situations, (2) describe the effects of the perceptions of risk on clinical decision making and behavior, and (3) identify what factors nurses perceive as increasing or decreasing risk.

Mesozeaxanthin protects the liver and reduces cardio-metabolic risk factors in an insulin resistant rodent model.

Background: Mesozeaxanthin (MZ) is a macular carotenoid which has been reported to have a number of pharmacological properties, including the antioxidant, and anticarcinogenic property, and has been stated to decrease the hepatocyte lipid content. Objective: In this study, we investigated the effect of MZ on cardio-metabolic health risk (CMHR) and its probable mechanisms of action in rats fed a high-fat diet (HFD). Design: Rats were randomly divided into four groups consisting of (i) Control, (ii) MZ, (iii) HFD, and (iv) HFD+MZ. Results: MZ treatment increased the antioxidant enzyme activities and helped improve the liver function. The treatment alleviated CMHR and decreased the level of nuclear factor kappa B (NF-κB p65) and tumor necrosis factor-alpha (TNF-α). The levels of hepatic peroxisome proliferator-activated receptor gamma (PPAR-γ), phosphorylated insulin receptor substrate 1 (p-IRS-1), ß,ß-carotene 9',10'-oxygenase 2 (BCO2) and nuclear factor erythroid 2-related factor 2 (Nrf2), which decrease in HFD rats, were found to be significantly higher in MZ supplemented animals. Conclusion: MZ has antioxidant and anti-inflammatory properties and can is reported in this study toprotect against fatty liver and cardio-metabolic syndrome, possibly through regulation of PPAR-γ, IRS-1, Nrf2 and NF-κB proteins, in an insulin-resistant rodent model.

The American College of Surgeons Children's Surgery Verification and Quality Improvement Program: implications for anesthesiologists.

PURPOSE OF REVIEW: The Task Force for Children's Surgical Care, an ad-hoc multidisciplinary group of invited leaders in pediatric perioperative medicine, was assembled in May 2012 to consider approaches to optimize delivery of children's surgical care in today's competitive national healthcare environment. Over the subsequent 3 years, with support from the American College of Surgeons (ACS) and Children's Hospital Association (CHA), the group established principles regarding perioperative resource standards, quality improvement and safety processes, data collection, and verification that were used to develop an ACS-sponsored Children's Surgery Verification and Quality Improvement Program (ACS CSV). RECENT FINDINGS: The voluntary ACS CSV was officially launched in January 2017 and more than 125 pediatric surgical programs have expressed interest in verification. ACS CSV-verified programs have specific requirements for pediatric anesthesia leadership, resources, and the availability of pediatric anesthesiologists or anesthesiologists with pediatric expertise to care for infants and young children. SUMMARY: The present review outlines the history of the ACS CSV, key elements of the program, and the standards specific to pediatric anesthesiology. As with the pediatric trauma programs initiated more than 40 years ago, this program has the potential to significantly improve surgical care for infants and children in the United States and Canada.

Impact of a Successful Speaking Up Program on Health-Care Worker Hand Hygiene Behavior.

BACKGROUND: Health-care worker (HCW) hand hygiene (HH) is the cornerstone of efforts to reduce hospital infections but remains low. Real-time mitigation of failures can increase process reliability to > 95% but has been challenging to implement for HH. OBJECTIVE: To sustainably improve HCW HH to > 95%. METHODS: A hospital-wide quality improvement initiative to improve HH was initiated in February 2012. HCW HH behavior was measured by covert direct observation utilizing multiple-trained HCW volunteers. HH compliance was defined as correct HH performed before and after contact with the patient or the patient's care area. Interventions focusing on leadership support, HCW knowledge, supply availability, and culture change were implemented using quality improvement science methodology. In February 2014, the hospital began the Speaking Up for Safety Program, which trained all HCWs to identify and mitigate HH failures at the moment of occurrence and addressed known barriers to speaking up. RESULTS: Between January 1, 2012, and January 31, 2016, there were 30,514 HH observations, averaging 627 observations per month (9% attending physicians, 12% resident physicians, 46% nurses, 33% other HCW types). HCW HH gradually increased from 75% to > 90% by December 2014. After the Speaking Up for Safety Program, HCW HH has been > 95% for 20 months. Physician HH compliance has been above 90% for over a year. CONCLUSION: Creating a specific process for staff to speak up and prevent HH failures, as part of a multimodal improvement effort, can sustainably increase HCW HH above 95%.

Salacia Extract Improves Postprandial Glucose and Insulin Response: A Randomized Double-Blind, Placebo Controlled, Crossover Study in Healthy Volunteers.

Thirty-five healthy subjects were randomly assigned to different doses of Salacia chinensis extract (200 mg, 300 mg, and 500 mg SCE) capsules and compared with placebo. It is a placebo controlled randomized crossover design study. Subjects were given oral sucrose solution along with capsules and plasma glucose and insulin responses were analyzed. Blood samples were collected at 0, 30, 60, 90, 120, and 180 minutes after administration. AUC insulin significantly lowered after ingestion of SCE. No significant adverse events were observed. Reducing glucose and insulin is very important in reducing postprandial hyperglycemia.

Overall skin tone and skin-lightening-improving effects with oral supplementation of lutein and zeaxanthin isomers: a double-blind, placebo-controlled clinical trial.

PURPOSE: Carotenoids, especially lutein and zeaxanthin isomers (L/Zi), filter blue light and protect skin from environmental factors including high-energy sources. These carotenoids may be able to block the formation of melanin pathways, decrease cytokines, and increase antioxidants. SUBJECTS AND METHODS: This is a randomized, double-blind, placebo-controlled clinical trial over a 12-week supplementation period. Fifty healthy people (50 healthy subjects were recruited and 46 subjects completed the study) (males and females, age: 18-45 years) with mild-to-moderate dry skin were included in this study. Skin type of the subjects was classified as Fitzpatrick skin type II-IV scale. Subjects were administered with either an oral dietary supplement containing 10 mg lutein (L) and 2 mg zeaxanthin isomers (Zi) (L/Zi: RR-zeaxanthin and RS (meso)-zeaxanthin) or a placebo daily for 12 weeks. The minimal erythemal dose and skin lightening (L*) were measured via the Chromameter®. The individual typological angle was calculated. Subjective assessments were also recorded. RESULTS: Overall skin tone was significantly improved in the L/Zi group compared to placebo (P<0.0237), and luminance (L*) values were significantly increased in the L/Zi group. Mean minimal erythemal dose was increased with L/Zi supplementation after 12 weeks of supplementation. L/Zi supplementation significantly increased the individual typological angle. CONCLUSION: L/Zi supplementation lightens and improves skin conditions.

Optimal Timing of Surgical Procedures in Pediatric Patients.

The Pediatric Anesthesia Neuro Development Assessment (PANDA) team at the Anesthesiology Department at Columbia University Medical Center held its fifth biennial symposium to discuss issues regarding potential neurotoxicity of anesthetic agents in pediatric patients. Overall optimal surgical timing as well as a "critical window" for surgery on a specialty specific basis are areas of focus for the American Academy of Pediatrics Surgical Advisory Panel. An ad hoc panel of pediatric surgical experts representing general surgery, urology, neurosurgery, and ophthalmology was assembled for this meeting and provided a dialogue focused on the benefits of early intervention versus potential anesthetic risk, addressing parental concerns, and the need for continued interdisciplinary collaboration in this area.

Mesozeaxanthin Protects Retina from Oxidative Stress in a Rat Model.

PURPOSE: Mesozeaxanthin (MZ) is able to protect against chronic and cumulative eye damage and neutralize free radicals produced by oxidative stress. The objective of the present study was to evaluate the protective potential of MZ against retinal oxidative damage and growth and transcription factors of the retina in rats fed with high-fat diet (HFD). METHODS: Twenty-eight Sprague Dawley rats were randomly divided into the following 4 groups: (1) Control, (2) MZ (100 mg/kg bw/d), (3) HFD (42% of calories as fat), and (4) HFD+MZ (100 mg/kg bw/d) group rats were administered daily as supplement for 12 weeks. RESULTS: Consumption of HFD was associated with hyperglycemia and oxidative stress as reflected by increased serum MDA concentration (P < 0.001). No measurable zeaxanthin (Z)+MZ and lutein (L) could be detected in the serum of control and HFD rats, whereas they were observed in the serum of MZ-administered rats. Retinal antioxidant enzyme [superoxide dismutase (SOD) and catalase (CAT)] activities were significantly decreased in the HFD group compared to the normal group (P < 0.01). However, retinal antioxidant enzymes were restored close to normal levels in HFD+MZ-treated rats (P < 0.05). The retina of rats fed with HFD had increased levels of vascular endothelial growth factor (VEGF), inducible nitric oxide (iNOS), intercellular adhesion molecule-1 (ICAM-1), and nuclear factor-kappa B (NF-κB) levels and decreased nuclear factor erythroid 2-related factor 2 (Nrf2) and heme-oxygenase 1(HO-1) levels compared to the healthy rat retina (P < 0.001). Rats treated with MZ partially alleviated the inflammation as reflected by suppressed VEGF, iNOS, ICAM, and NF-κB levels and increased Nrf2 and HO-1 levels in the retina of rats fed (P < 0.05). CONCLUSIONS: Results from the present study suggest that MZ has protective effects on the retina and the ability to modulate oxidative stress of retina in rats fed an HFD by suppressing retinal lipid peroxidation and regulating growth and transcription factors.

Tolerability of Capsaicinoids from Capsicum Extract in a Beadlet Form: A Pilot Study.

A single center, open-label, dose-finding adaptive study was conducted in twelve healthy overweight female subjects. The study was to evaluate the safety and tolerability of the capsaicinoids (CAPs) from Capsicum extract in a beadlet form compared to placebo in a healthy overweight population. The investigational product capsaicinoids (CAPs) from Capsicum extract in a beadlet form (Capsimax®) a proprietary encapsulated form of Capsicum extract in beadlet form supplemented at 2 mg, 4 mg, 6 mg, 8 mg and 10 mg of CAPs. An ascending dose protocol evaluated a total dose of 10 mg daily given in five divided doses (2 mg, 4 mg, 6 mg, 8 mg and 10 mg of CAPs). Each dose was given for a week. Safety and tolerability were assessed. Primary outcomes were tolerability assessments and reports of adverse events. Tolerability assessments were observed on skin color and any changes in skin, bowel movement, digestion, mouth or throat, hair color or changes in hair color, urination includes frequency and burning sensations, breathing, any changes in their health. Secondary outcomes were body weight, body mass index (BMI), blood pressure (SBP/DBP), vital signs, electrocardiograms, clinical chemistry parameters including liver function tests, lung function tests and kidney function tests and complete blood count (CBC). No dose effective changes were observed. The escalating dose levels of CAPs in a beadlet form product found was tolerable and safe for weight management studies. Tolerability assessments and safety blood markers showed no significant changes from baseline. No significant serious adverse events were reported throughout the duration of the study. Further longer term studies are required to explore the tolerability of the product. This trial is registered with ISRCTN: # ISRCTN10975080.

Successful development of a direct observation program to measure health care worker hand hygiene using multiple trained volunteers.

BACKGROUND: Direct observation of health care worker (HCW) hand hygiene (HH) remains the gold standard, but implementation is challenging. Our objective was to develop an accurate HH observation program using multiple HCW volunteers. METHODS: HH compliance was defined as correct HH performed before and after contact with a patient or a patient's environment. HCW volunteers from each unit at our children's hospital were trained by infection preventionists to covertly collect HH observations during routine care using an electronic tool. Questionnaires sent to observers in February and December 2014 recorded demographic characteristics, observation time, and scenarios assessing accuracy. HCWs were surveyed regarding their awareness that their HH behavior was being recorded. RESULTS: There were 146 HH observers. The majority of observers reported making 1-2 observations per shift (65%) and taking ≤10 minutes recording an observation (85%). Between January 2012 and December 2014 there were 22,484 HH observations (average, 622 per month), including nurses (46%), physicians (21%), and other HCWs (33%). Observers correctly recorded HH behavior more than 90% of the time in 5 of the 6 scenarios. Most HCWs (86%) were unaware they were being observed. CONCLUSION: A direct observation program staffed by multiple HCW volunteers can inexpensively and accurately collect HCW HH data.

Safety evaluation of zeaxanthin concentrate (OmniXan™): acute, subchronic toxicity and mutagenicity studies.

The available evidence suggests a beneficial effect of zeaxanthin against the progression of age-related macular degeneration (AMD). The objective of the present study was to investigate potential adverse effects of OmniXan™, a RR-zeaxanthin (65%) enriched product obtained from paprika (Capsicum annum fruits) in subchronic toxicity and mutagenicity studies. The oral LD50 of OmniXan(TM) in rats was greater than 2000 mg/kgbody weight (bw)/day. For the subchronic toxicity study, Wistar rats (10/sex/group) were gavaged daily with zeaxanthin concentrate at doses of 0, 4, 40 and 400 mg/kg bw/day for 90-days. No treatment related clinical signs and mortalities observed. Similarly, no treatment related toxicologically significant changes in body weight, feed consumption; ophthalmoscopic examination, neurological examination, hematology, urine analysis and organ weights were observed. Statistically significant changes observed in some clinical chemistry parameters were considered toxicologically and biologically insignificant and nonadverse. Macroscopic and microscopic examinations did not reveal treatment-related abnormalities. The results of mutagenicity testing using Salmonella typhimurium did not reveal any genotoxicity. The no observed-adverse-effect level (NOAEL) for zeaxanthin concentrate (OmniXan(TM)) was determined as 400 mg/kg bw/day, the highest dose tested. The findings of this subchronic toxicity and mutagenicity studies support safety of zeaxanthin concentrate.

National pediatric anesthesia safety quality improvement program in the United States.

BACKGROUND: As pediatric anesthesia has become safer over the years, it is difficult to quantify these safety advances at any 1 institution. Safety analytics (SA) and quality improvement (QI) are used to study and achieve high levels of safety in nonhealth care industries. We describe the development of a multiinstitutional program in the United States, known as Wake-Up Safe (WUS), to determine the rate of serious adverse events (SAE) in pediatric anesthesia and to apply SA and QI in the pediatric anesthesia departments to decrease the SAE rate. METHODS: QI was used to design and implement WUS in 2008. The key drivers in the design were an organizational structure; an information system for the SAE; SA to characterize the SAE; QI to imbed high-reliability care; communications to disseminate the learnings; and engaged leadership in each department. Interventions for the key drivers, included Participation Agreements, Patient Safety Organization designation, IRB approval, Data Management Co., membership fee, SAE standard templates, SA and QI workshops, and department leadership meetings. RESULTS: WUS has 19 institutions, 39 member anesthesiologists, 734 SAE, and 736,365 anesthetics as of March, 2013. The initial members joined at year 1, and initial SAE were recorded by year 2. The SAE rate is 1.4 per 1000 anesthetics. Of SAE, respiratory was most common, followed by cardiac arrest, care escalation, and cardiovascular, collectively 76% of SAE. In care escalation, medication errors and equipment dysfunction were 89%. Of member anesthesiologists, 70% were trained in SA and QI by March 2013; virtually, none had SA and QI expertise before joining WUS. CONCLUSION: WUS documented the incidence and types of SAE nationally in pediatric anesthesiology. Education and application of QI and SA in anesthesia departments are key strategies to improve perioperative safety by WUS.

Formulation development, optimization, and evaluation of sustained release tablet of valacyclovir hydrochloride by combined approach of floating and swelling for better gastric retention.

The present study is intended to enhance gastric retention of sustained release tablet of valacyclovir hydrochloride by combined approach of floating and swelling. The tablets are prepared by direct compression method. Polyethylene oxide (Polyox WSR 303) is selected as the swelling matrix agent. Sodium starch glycolate (SSG) is used as swelling enhancer, and sodium bicarbonate is used as an effervescent agent for floating. A 3(2) full factorial design is applied to systematically optimize the formulation. The concentration of Polyox WSR 303 (X 1) and concentration of SSG (X 2) are selected as independent variables. The percentage drug release at 12 h, floating lag time, and maximum percentage swelling are selected as dependent variables. Formulations are evaluated for hardness, friability, floating lag time, total floating time, percentage swelling, in vitro drug release, and in vivo floating study. The results indicated that X 1 and X 2 significantly affected the drug release properties, floating lag times, and maximum percentage swelling. Release rate decreases as the concentration of Polyox increased. Regression analysis and numerical optimization are performed to identify the best formulation. Formulation F5 prepared with Polyox WSR 303 (15 %) and SSG (10 %) is found to be the best formulation. F5 followed zero-order release mechanism. Swelling and floating gastroretentive tablets of valacyclovir HCl are successfully formulated with controlled delivery to stomach with an aim of increasing the mean residence time in the upper part of GIT where the drug has its absorption window.

Pediatric perioperative life support.

Pediatric advanced life support training and guidelines are typically designed for first-responders and out-of-hospital resuscitation. Guidelines and scenarios that are more applicable to the perioperative environment would be beneficial for anesthesiologists. The goal of this article is to review resuscitation of pediatric patients during the perioperative period. We use a format that focuses on preresuscitation preparation, resuscitation techniques, and postresuscitation management in the perioperative period. In an effort to provide information of maximum benefit to anesthesiologists, we include common pediatric perioperative arrest scenarios with detailed description of their management. We also provide a section on postresuscitation management and review the techniques for maintaining the child's hemodynamic and metabolic stability. Finally, 3 appendices are included: an example of an intraoperative arrest record that provides feedback for interventions; a table of key medications for pediatric perioperative resuscitation; and a review of defibrillator use and simulation exercises to promote effective defibrillation.