Optimizing Resources in Children’s Surgical Care: An Update on the American College of Surgeons' Verification Program

An estimated 5 million ambulatory and inpatient operations are performed on infants and children annually at thousands of sites in the United States.^1,2  Evidence suggests that some operations are performed in environments lacking the optimal levels of expertise and/or resources.³ 

Studies since the early 1960s comparing outcomes at different ages have consistently demonstrated increased perioperative morbidity and mortality in infants younger than 1 year, with infants younger than 1 month demonstrating the highest risk.^4,5  Both the incidence of perioperative cardiac arrest and death were more than 20-fold higher in infants younger than 30 days compared with children older than 10 years.⁶  Pediatric-specific anesthesiology training was subsequently associated with reductions in anesthesia-related morbidity.^7,8  In one survey in which respondents self-reported pediatric anesthesia-related complications such as inadequate ventilation, overdose of anesthetic, cardiac arrest, pulmonary aspiration, complications attributable to regional anesthesia, and acute pulmonary edema, anesthesiologist-specific annual pediatric anesthesia case volume was inversely correlated with the incidence of complications, with the best-achieving practitioners performing >250 pediatric anesthesia cases annually.⁹ 

In 1999, given concerns that many pediatric patients were undergoing surgery in environments without pediatric-specific expertise and equipment available, the American Academy of Pediatrics (AAP) Section on Anesthesiology and Pain Medicine published guidelines for the pediatric perioperative anesthesia environment.¹⁰  These guidelines were subsequently updated in 2015 and specifically aligned with the American College of Surgeons (ACS) Children’s Surgery Verification (CSV) standards.³  The updated guidelines included recommendations that younger children and children with significant comorbidities should be cared for by board-certified or -eligible pediatric anesthesiologists. In 2012, the American Board of Anesthesiology established board certification standards for pediatric anesthesia in the form of a certificate of added qualifications in pediatric anesthesiology (Table 1). As of 2015, more than 4000 pediatric anesthesiologists in the United States have obtained this certification, and 191 pediatric anesthesia fellowship training positions are available (up 162% from 2002 to 2015).¹¹  Projections based on current trends suggest that more than 7000 pediatric anesthesiologists will be practicing in the United States by 2035.¹¹ 

Compelling evidence exists that some degree of regionalization of complex children’s surgical care improves outcomes. Using statewide hospital discharge databases for the states of California in 1988 and Massachusetts in 1989, Jenkins et al¹³  demonstrated that children undergoing surgery for a congenital heart defect were at much lower risk of dying in the hospital if the surgery was performed at a high-volume institution (>300 cases annually).¹³  Using discharge data for the state of California from 1995 to 1997, Chang and Klitzner¹⁴  modeled a statewide system in which cases from low- and medium-volume centers were transferred to a small number of high-volume and high-performing centers and demonstrated a significant theoretical decrease in deaths associated with surgery for a congenital heart defect.¹⁴  Similarly, using data from the California Perinatal Quality Care Collaborative from 2005 to 2011, Kastenberg et al¹⁵  showed lower risk-adjusted mortality in very low birth weight infants with necrotizing enterocolitis in high-volume level III NICUs compared with low-volume level III NICUs. Using data from the 2010 National Trauma Data Bank, Webman et al¹⁶  showed that the risk-adjusted mortality rate for injured adolescents was lower when treated at pediatric trauma centers compared to adult trauma centers. These data again indicate that mortality outcomes are improved when care is delivered in centers with appropriately matched expertise and resources.

Children who receive care for less complex surgical problems at hospitals with more robust pediatric resources also have better clinical outcomes than those treated at less well-resourced facilities. For instance, although patients had more severe disease related to intussusception, the rate of bowel resection was lower in pediatric facilities compared to nonpediatric facilities in the state of Washington.¹⁷  Similarly, risk of complications related to surgical treatment of appendicitis and pyloric stenosis was lower for children at pediatric hospitals compared with nonpediatric hospitals.¹⁸  These studies demonstrate that management of children with certain surgical conditions at centers with greater expertise and/or resources generally results in fewer adverse outcomes.

Programs have been developed on national and state levels to promote regionalization and establish criteria for a range of care levels with the goal of optimizing disease-specific outcomes. In 1976, the ACS established criteria for categorizing hospitals on the basis of availability of resources for the care of traumatic injuries. In 1987, in an effort to regionalize systems care for trauma patients, the ACS Committee on Trauma established the trauma site verification program (https://www.facs.org/quality-programs/trauma) (Table 1). After the regionalization of trauma care,¹⁹  MacKenzie et al²⁰  demonstrated that mortality risk for similarly injured adults was significantly lower in trauma centers compared with nontrauma centers.

In 2004, an AAP policy statement proposed a classification system that was based on the functional capabilities of NICUs with the goal of matching the acuity and complexity of a neonate with the expertise and resources of the treating unit.²¹  The AAP proposed that regionalized systems should be organized on the basis of defined capabilities of the various units to optimize the care of newborn infants. This policy has been reaffirmed twice since the original statement, most recently in 2012, at which time levels of care were restratified as I through IV (level IV being the highest).¹²  In the latest policy statement, additional literature was cited demonstrating superior survival outcomes for very low birth weight (<1500 g) and extremely low birth weight (<1000 g) infants in level III NICUs compared to level I and II NICUs as well as superior survival outcomes in higher-volume centers of equivalent level. In 2016, the AAP initiated a NICU Verification Program (https://www.aap.org/en-us/advocacy-and-policy/aap-health-initiatives/nicuverification) (Table 1). This program initially was developed to verify adherence to the Texas regulations regarding NICU levels of care (https://dshs.texas.gov/emstraumasystems/neonatal.aspx), which were developed on the basis of attributes of each level, as described in the AAP policy statement “Levels of Neonatal Care.”¹² 

The ad hoc Task Force for Children’s Surgical Care was established in 2012 to address the potential mismatch of resources and an individual child’s surgical needs in the United States. This multidisciplinary group comprising children’s general and specialty surgeons, pediatric anesthesiologists, and others relevant to comprehensive perioperative care of infants and children met on 4 occasions and worked continuously between 2012 and 2015 to develop a consensus approach to matching resources with children’s surgical needs and prepare an initial report.²²  This report included components of optimal resources for basic, advanced, and comprehensive children’s surgical centers. Participants in the task force included representatives from the AAP, ACS, the American Pediatric Surgical Association, Children’s Hospital Association, the Committee on Pediatric Anesthesia of the American Society of Anesthesiologists, and the Society for Pediatric Anesthesia.

Given the task force’s white paper, the ACS CSV Quality Improvement Program was modeled after the well-established ACS verification programs that support a quality portfolio including trauma, colorectal cancer, breast cancer, and bariatric surgery. In 2015, the ACS released final standards for the CSV Quality Improvement Program as its fifth quality improvement program (Table 1). ACS CSV–verified programs are stratified from I through III (level I is the highest) on the basis of available resources and demonstrable commitment to pediatric surgical care (Table 2).

The main principles that form the foundation for the ACS CSV Program include the development of standards based on research, definition of infrastructure, a robust performance improvement process, rigorous data collection, and an external peer review verification process. Level I verification requires the presence of a wide range of pediatric subspecialists along with a level IV NICU and a PICU. In addition to pediatric general and specialty surgeons, pediatric proceduralists, including gastroenterology, pulmonary medicine, and interventional radiology, are also required in this multidisciplinary effort. A level III NICU is the minimum requirement for level II ACS CSV status. Institutional membership in the ACS National Surgical Quality Improvement Program Pediatric (NSQIP-Pediatric) (https://www.facs.org/quality-programs/pediatric) is required for standardized data collection for level I and level II ACS CSV centers; although this is not a requirement for level III ACS CSV status, institutional data collection is still required. ACS NSQIP-Pediatric is a nationally validated, risk-adjusted outcomes assessment program used to measure and improve the quality of children’s surgical care among more than 100 participating centers by reporting of institution’s adverse events rates compared with those of peer institutions. As with all ACS verification programs, a dedicated administrative team, comprising a surgeon (NSQIP-Pediatric champion) and support staff, is vital to the success of the program. The current annual fees to participate in CSV and ACS NSQIP-Pediatric are listed at https://www.facs.org/quality-programs/childrens-surgery/fees. Reverification is performed every 3 years.

An up-to-date list of all verified centers is listed on the program Web site at https://www.facs.org/quality-programs/childrens-surgery/childrens-surgery-verification/centers. An additional 150 centers have expressed interest in verification. After receipt of a CSV application and submission of the prereview questionnaire, a reviewer team is selected. The team is a combination of 3 reviewers. The team always includes a specialty-qualified children’s surgeon(s) and a pediatric anesthesiologist. The team may also include a pediatric nurse. The reviewers are selected by the ACS CSV Program staff. The review team is provided relevant documents and an organized agenda in advance of the site visit. Guidelines ensure consistent and appropriate conduct of the review. After the site visit, a standardized report is generated and reviewed by the ACS CSV Committee, which makes the final decision regarding verification.

Lessons learned from completed verification visits include the importance of developing institution-wide, multidisciplinary process improvement structures, and the need for robust resource commitments that prioritize pediatric patient safety and encourage quality improvement initiatives. In addition, establishing and maintaining pediatric-specific resources (nursing, operating rooms, etc) and focused attention on pediatric provider training and availability are essential.

ACS CSV is a voluntary program that, if implemented uniformly, would enable all hospitals to identify and advocate for shortfalls in important resources for optimizing children’s surgical care. Without augmentation of resources, Baxter et al,²⁴  using the 2009 Kids’ Inpatient Database, estimated conservatively that more than one-third of all neonates with complex surgical conditions would need to be relocated from level II or III hospitals to a level I hospital.²⁴  Using propensity score-adjusted logistic regression, the authors further estimated 1 life saved for every 32 neonates relocated, with a median distance traveled of 6.6 miles (range up to >200 miles). The authors did not analyze the implications on morbidity and its associated costs. Although access to care is important, the goal of ACS CSV is ensuring the best care possible for each child requiring surgery, and site review can be used to advocate for pediatric perioperative resources important to achieving this goal.

Going forward, the ACS CSV Program actively collaborates with the AAP NICU Verification Program in Texas. The program also collaborates with Wake Up Safe, an anesthesia quality improvement program supported by the Society for Pediatric Anesthesia. As more hospitals undergo children’s surgical verification, outcomes will be assessed to ascertain whether the process results in demonstrable improvements in children’s health, as has been documented with trauma program verification.

The goal of the ACS CSV Program is to improve the quality of care for children requiring surgery by matching individual patient needs (including surgical complexity and comorbidities) with appropriate and optimal perioperative resources (including equipment and personnel). The ACS CSV Program is actively collaborating with the AAP NICU Verification Program. The program, which has been endorsed by the AAP, has already verified several programs, and it is projected that at least 20 additional pediatric perioperative programs will be verified by 2020. Ensuring that hospital resources are matched with children’s surgical needs is expected to optimize clinical outcomes.

AAP

American Academy of Pediatrics

ACS

American College of Surgeons

CSV

Children’s Surgery Verification

NSQIP-Pediatric

National Surgical Quality Improvement Program Pediatric

Kasper S. Wang, MD, FAAP – Section on Surgery

James Cummings, MD, FAAP – Committee on Fetus and Newborn

Ann Stark, MD, FAAP – NICU Verification Program

Constance Houck, MD, MPH, FAAP – Surgical Advisory Panel

Keith Oldham, MD, FAAP

Catherine Grant, BSN, RN

Mary Fallat, MD, FAAP – American College of Surgeons Children’s Surgery Verification Committee

Gail Ellen Besner, MD, Chairperson

Mary Fallat, MD, FAAP, Immediate Past Chairperson

Marybeth Browne, MD

Andrew Davidoff, MD, Incoming Chairperson

Cynthia D. Downard, MD

Kenneth William Gow, MD

Saleem Islam, MD

Vivian B. Thorne

James Cummings, MD, FAAP, Chairperson

Kristi Watterberg, MD, Immediate Past Chairperson

Ira S. Adams-Chapman, MD

Susan Aucott, MD

Jay P. Goldsmith, MD

Ivan Hand, MD

David Kaufman, MD

Camilia Martin, MD

Karen Puopolo, MD, PhD

Michael Narvey, MD – Canadian Paediatric Society

Russell Miller, MD – American College of Obstetricians and Gynecologists

RADM Wanda Barfield, MD, MPH – Centers for Disease Control and Prevention

Erin Keels, DNP, APRN, NNP-BC – National Association of Neonatal Nurses

Timothy Jancelewicz, MD – American Academy of Pediatrics Section on Surgery

Meredith Mowitz, MD, MS – American Academy of Pediatrics Section on Neonatal and Perinatal Medicine

Jim Couto, MA

Anita Honkanen, MD, Chairperson

Mary Landrigan-Ossar, MD, PhD, Chair-Elect

Raeford Brown, MD, Immediate Past Chairperson

Christina D. Diaz, MD

Lisa Wise-Faberowski, MD

Stephen Hays, MD

Debnath Chatterjee, MD

Rita Agarwal, MD – Society for Pediatric Pain Medicine

Kirk Lawani, MD – Society for Pediatric Anesthesia

Constance Houck, MD, MPH, FAAP – American Academy of Pediatrics Committee on Drugs

Sulpicio Soriano II, MD – American Society of Anesthesiologists Committee on Pediatric Anesthesia

Jennifer Riefe