Tag Archive for: Quality and Safety

Dr. Wayne Franklin and patient

Qualities of successful pediatric and congenital cardiovascular programs: Cardiology 2025

Dr. Wayne Franklin and patient

Dr. Franklin’s talk offered his observations of how the administrative backbone behind clinical care supports a thriving center for infants and children with congenital heart disease and their families.

Wayne Franklin, MD, FACC, senior vice president of Children’s National Heart Center, joined a panel discussion at Cardiology 2025: The 28th Annual Update on Pediatric and Congenital Heart Disease. The panel, Healthcare Administration in Pediatric and Congenital Cardiovascular Disease: Sharing Challenges and Creating Solutions, sought to identify the traits that successful U.S. healthcare programs, and especially pediatric cardiovascular programs, have in common.

Dr. Franklin’s talk, “Structuring Administration for Pediatric & Congenital Cardiovascular Care,” offered his observations of how the administrative backbone behind clinical care supports a thriving center for infants and children with congenital heart disease and their families.

The big picture

Dr. Franklin noted that the best programs are finding successful combinations of the right ingredients to make the “secret sauce” — focus on high quality care being delivered in ways that are financially sustainable. More than ever, this is hard to accomplish.

Today’s pediatric programs are often organized in an academic model where clinicians are employed by a university or medical school, typically within a Department of Pediatrics, with pediatric subspecialties all falling together under that department. While the academic model has been successful up to this point, there may be valuable lessons to learn and opportunities for further success by looking at outcomes from other models in the broader adult healthcare sector.

Key takeaways

Dr. Franklin offered several examples of key models for pediatric heart centers to consider. They include:

  • A multi-disciplinary, “service-line centered” structure: All doctors, nurses, advanced practice providers and support staff aligned together under a “center” or “institute” model, similar to the Cleveland Clinic’s Institutes of Excellence.
  • A blended, “privademic” structure for clinicians, where they are direct employees of a hospital, but not of a larger university or healthcare system.
  • Clinician leadership and engagement in business administration structure and function, to make sure that patients remain front and center in business decisions.
  • Dedicated quality and safety teams that are driven by data and outcomes, foster frequent and early communication and ensure care providers actively engage with these efforts.
  • A model that supports innovations in care and investments in research to continue advancing best practices for patients and families.
  • A system for education and training to make sure the next generation can effectively carry on the established culture of excellence.

What matters most

No matter the structure, the most important and common theme among successful health systems, hospitals and even specific heart programs, is steadfast, organization-wide dedication to decision making driven by what is best for patients. This approach should drive a focus on early detection and/or prevention, and lead to positive outcomes, which ultimately brings financial sustainability.

See more about Children’s National at this year’s meeting: Cardiology 2025: 28th Annual Update on Pediatric and Congenital Cardiovascular Disease.

Smiling boy in hospital bed

Perspective: Rethinking racial benchmarks in pediatric safety events

Smiling boy in hospital bed

The research team estimated that 754 pediatric safety events could be avoided annually if all racial groups performed as well as the top-rated group for each type of safety event studied.

Quality and safety would improve in pediatric healthcare – for all races – if the practice of benchmarking outcomes and performance against white patients changed. Instead, investigators should consider using the best-performing group to improve healthcare disparities, according to a new Pediatrics perspective from a multi-center research team led by Children’s National Hospital.

The team examined seven pediatric safety indicators from their previous research, including postoperative infection and accidental lacerations. They determined the best-performing group was not always the white subset, but data in scientific research is often benchmarked against white patients. This can perpetuate racism and erroneously imply that white patients should define the standard for healthcare, the investigators found.

The patient benefit

The research team estimated that 754 pediatric safety events could be avoided annually if all racial groups performed as well as the top-rated group for each type of safety event studied. For some safety events, this would require benchmarking against Black, Hispanic, Asian and Pacific Islander populations.

“By looking at the data with a new lens, we believe that clinicians and researchers could make a major step forward in shrinking and eliminating disparities across pediatric healthcare,” said Kavita Parikh, M.D., MSHS, medical director of Quality & Safety Research and research director of the Division of Hospital Medicine at Children’s National. “If we can employ a more precise understanding of patient and family experience as they interact with the healthcare system, we can prevent negative outcomes that can impact entire lifetimes.”

What’s ahead

The multi-center team continues to work on ways to improve quality and safety at pediatric hospitals. With broad partnerships, the researchers hope to redesign national safety models to encourage hospitals to overcome health-equity hurdles, such as racism, language barriers and other social factors that lead to disparities.

“This call to action is not new, but it demands renewed urgency,” said Dr. Parikh, the first author of the perspective. “We propose future analyses that infuse antiracist principles with quality improvement and patient safety standards to design more effective interventions.”

You can read the complete perspective – “Analyzing Pediatric Safety Events Using Antiracist Principles” – in Pediatrics.

Team performing cardiac surgery at Children's National

Long-term outcomes are key measure of CHD care quality and safety

Short-term outcomes data may be one benchmark of the quality and safety found in a pediatric cardiac surgery program, but according to the team at Children’s National Hospital, it shouldn’t be the sole factor in how referring physicians and families make decisions about where to seek care.

Instead, physicians and families need more information about what to expect for a child’s entire lifespan. To meet this need, the Division of Cardiac Surgery at Children’s National has launched the Children’s National Cardiac Outcomes Registry (CNCOR), a first-of-its-kind database that captures outcomes from 15-plus years of congenital heart surgical repairs for specific congenital heart conditions.

What it means

Today, most pediatric heart programs publicly share their outcomes based on benchmarks defined by the Society for Thoracic Surgeons (STS). For cardiac surgery, the data points are focused on the short-term outcomes for various procedures, ranging from 30 days to one year after surgery.

However, as surgical procedures have been refined and multi-disciplinary teams continually improve their knowledge of how to treat children with these congenital heart defects, more children with these conditions are living far beyond those time frames. One metric, operative mortality for “index cases” defined by the STS (excluding VAD and ECMO), measures how many children having heart surgery with the cardiopulmonary bypass die during surgery or within the 30 days after surgery.

Recently at Children’s National, the Cardiac Surgery, Cardiac Intensive Care Unit, Cardiology and Cardiac Anesthesia teams had a remarkable year with zero operative mortality, or no deaths, for the types of cases included in this benchmark. While it’s impossible to expect zero mortality to continue indefinitely when caring for children with the most severe and complex heart conditions — as is the case at Children’s National — the national average operative mortality for these procedures is closer to 3%.

Yves d’Udekem, M.D., Ph.D., chief of Cardiac Surgery at Children’s National, says that this achievement is not one he expected to “ever see in his lifetime” and is a testament to the teams’ dedication to providing the highest quality care every day. However, he also noted, “Achieving such impressive statistics for short-term measures has never been, is not, and will never be my objective. We also need to look beyond it. What happens to this patient 5, 10 or 15 years down the line? That’s what we want to know.”

Children’s National leads the way

The CNCOR collects long-term data from 20 years of cardiac surgical procedures at Children’s National. This data has allowed Children’s National to create a series of charts that show predicted long-term outcomes for specific congenital heart conditions.

The charts are now available in a new Cardiac Surgery Long-Term Outcomes section on the website, organized by specific types of congenital heart disease, including:

  • Tetralogy of Fallot
  • Aortic arch coarctation
  • Atrioventricular septal defects
  • Transposition of the great arteries

For most conditions, data is available showing long-term mortality as well as re-operation or re-intervention rates for children who underwent these procedures at Children’s National, going as far back as the year 2000. Eventually, the database might expand to include indicators such as exercise capacity and neurological outcomes.

What’s next

The launch of the CNCOR is the start of efforts by the team at Children’s National to provide what Dr. d’Udekem calls “proper” benchmarking based on the whole life of a patient rather than a single event in time.

If more institutions collect and report this data and make it available, patients, families and practitioners who refer to cardiac surgery will have a true lifetime perspective of what a surgical procedure at a specific institution may mean for a child.

Boy lying in a hospital bed, surrounded by medical equipment

Black, Hispanic children at greater risk for complications during hospitalization

Boy lying in a hospital bed, surrounded by medical equipment

The research team found that patients who are Black and Medicaid-insured patients experienced the greatest disparities in postoperative sepsis, a rare complication in which patients suffer from infection that can cause multi-organ failure.

Evaluating more than 5 million pediatric hospital stays nationwide, researchers found children who are Black, Hispanic or insured with Medicaid face a greater risk of health events after surgeries than white patients, according to a new study published in the journal Pediatrics.

“We looked at the data, and we calculated the risks,” said Kavita Parikh, M.D., MSHS, medical director of Quality & Safety Research, research director of the Division of Hospital Medicine and first author on the multi-institute study. “Despite decades of focus on eliminating medical errors, we know that children continue to suffer substantial harms in hospital settings, and our study highlights where children who are Black, Hispanic or insured with Medicaid are at the greatest risk.”

The big picture

The study analyzed data from more than 5.2 million hospitalizations collected by the 2019 Kids’ Inpatient Database, a national repository of data on hospital stays. It includes a 10% sample of newborns and an 80% sample of other pediatric discharges from 4,000 U.S. hospitals. More than 80% of patients were younger than 1 year of age.

The research team found that patients who are Black and Medicaid-insured patients experienced the greatest disparities in postoperative sepsis, a rare complication in which patients suffer from infection that can cause multi-organ failure. Patients who are Hispanic experienced the greatest disparity in postoperative respiratory failure, a complication that can limit breathing and ventilation.

Plausible factors cited include structural racism in the U.S. healthcare system, clinician bias, insufficient cultural responsiveness, communication barriers and limited access to high-quality healthcare.

What’s ahead

The study – “Disparities in Racial, Ethnic, and Payor Groups for Pediatric Safety Events in U.S. Hospitals” – is foundational in understanding what is happening among pediatric patients. Dr. Parikh said that researchers now must conduct further studies into these alarming disparities and qualitative work to understand drivers, with the action-oriented goal of developing interventions to improve patient safety in the hospital for all children.

“We brought together leaders in pediatric medicine, health policy and public health to analyze this data, and we are committed to taking the next steps to improve outcomes for pediatric patients,” Dr. Parikh said. “It will take more patient-centered work and research, resources and multifaceted strategies to resolve these worrying disparities for our pediatric patients nationwide.”

Matt Oetgen and patient

Periop procedures improve scoliosis surgery infection rates

Matt Oetgen and patient

Matthew Oetgen, M.D., MBA, chief of orthopaedics and sports medicine at Children’s National Hospital, presented findings from a study aimed at improving quality and safety for pediatric spinal fusion procedures by reducing surgical site infection rates.

Pediatric orthopaedic surgery as a field is focused on improving quality and value in pediatric spine surgery, especially when it comes to eliminating surgical site infections (SSI). Many studies have documented how and why surgical site infections occur in pediatric spinal fusion patients, however, there is very little data about what approaches are most effective at reducing SSIs for these patients in a sustainable way.

At the Pediatric Orthopaedic Society of North America’s 2020 Annual Meeting, Matthew Oetgen, M.D., MBA, chief of orthopaedic surgery and sports medicine at Children’s National Hospital, presented findings from a long-term single institution study of acute SSI prevention measures.

“These findings give us specific insight into the tactics that are truly preventing, and in our case sometimes even eliminating, SSIs for pediatric scoliosis surgery,” says Dr. Oetgen, who also served on the annual meeting program committee. “By analyzing patient records across more than a decade, we were able to see that some strategies are quite effective, and others, that we thought would move the needle, just don’t.”

The team reviewed medical records and radiographs dating back to 2008 for 1,195 patients who had spinal fusion for scoliosis, including idiopathic scoliosis as well as other forms such as neuromuscular or syndromic scoliosis. Over that period of time, the division of orthopaedics and sports medicine at Children’s National was collaborating with the hospital’s infection control team to achieve several programmatic implementation milestones, including:

  • January 2012: Standardized infection surveillance program
  • July 2013: Standardized perioperative infection control protocols including those for pre-operative surgical site wash, surgical site preparation and administration of antibiotics before and after surgery
  • March 2015: Standardized comprehensive spinal care pathway including protocols for patient temperature control, fluid and blood management, and drain and catheter management

Over the study time period, the team found that SSIs did decrease, but interestingly, the rate did not progressively decrease with each subsequent intervention.

“Instead, we found that the rate went down and was even eliminated for some subgroups when the perioperative infection control protocols were implemented in 2013 and sustained through the study period end,” says Dr. Oetgen. “The other programmatic efforts that started in 2012 and 2015 had no impact on infection rates.”

He also notes that the study’s findings have identified a crucial component in the process for infection control in pediatric spinal surgery—perioperative protocols. “A relatively uncomplicated perioperative infection control protocol did the best job decreasing SSI in spinal fusion. Future efforts to optimize this particular protocol may help improve the rates even further.”

Holly Meany

TAA-Ts as therapy for tumors

Holly Meany

“The T cell immunotherapy regimen resulted in prolonged disease stabilization in patients who previously experienced rapid tumor progression,” says Holly Meany, M.D. “The therapy could prove to be an important component of immunotherapy for patients with solid tumor malignancies.”

In a study published in the Journal of Clinical Oncology, researchers from Children’s National Health System uncovered tumor-associated antigen cytotoxic T cells (TAA-Ts) that represent a new and potentially effective nontoxic therapeutic approach for patients with relapsed or refractory solid tumors.

The Phase 1 study led by Children’s National pediatric oncologists Holly Meany, M.D., and Amy B. Hont, M.D., represented the first in-human trial investigating the safety of administering TAA-Ts that target Wilms Tumor gene 1, a preferentially expressed antigen of melanoma and survivin in patients with relapsed/refractory solid tumors.

“These are exciting clinical results using a novel ‘first in-human’ T cell therapy,” said Catherine Bollard, MB.Ch.B., M.D., director of the Center for Cancer and Immunology Research at Children’s Research Institute. “This T cell therapy was safe and appeared to prolong patients’ time to progression which suggests that we can now use this novel treatment as a combination therapy to hopefully achieve long-term remissions in pediatrics and adults with relapsed/refractory solid tumors.”

During the Phase 1 trial, TAA-Ts products were generated from autologous peripheral blood and were infused over three dose levels. Patients were then eligible for up to eight infusions that were administered four to seven weeks apart.

Of the 15 evaluable patients, 11 were with stable disease or better at 45 days post-infusion and were defined as responders. Patients who were treated at the highest dose level showed the best clinical outcomes, with a 6-month progression-free survival rate of 73% after TAA-Ts infusion, an improvement as compared with prior therapy.

Overall, the Phase 1 trial of TAA-Ts resulted in safely induced disease stabilization and was associated with antigen spreading and a reduction in circulating tumor-associated antigen DNA levels in patients with relapsed/refractory solid tumors before infusion.

“The T cell immunotherapy regimen resulted in prolonged disease stabilization in patients who previously experienced rapid tumor progression,” said Dr. Meany. “The therapy could prove to be an important component of immunotherapy for patients with solid tumor malignancies,” she added.

The other researchers that contributed to this work are as follows: Amy B. Hont, M.D.; C. Russell Cruz, M.D., Ph.D.; Robert Ulrey, M.S.; Barbara O’Brien, B.S.; Maja Stanojevic, M.D.; Anushree Datar, M.S.; Shuroug Albihani, M.S.; Devin Saunders, B.A.; Ryo Hanajiri, M.D., Ph.D.; Karuna Panchapakesan, M.S.; Sam Darko, M.S.; Payal Banerjee, M.S.; Maria Fernanda Fortiz, B.S.; Fahmida Hoq, MBBS, M.S.; Haili Lang, M.D.; Yunfei Wang, Dr.PH.; Patrick J. Hanley, Ph.D.; Jeffrey S. Dome, M.D., Ph.D.; Catherine M. Bollard, M.D.; and Holly J. Meany, M.D.

QUILT conference

Children’s National hosts Quality Improvement Leadership Training Course

QUILT conference

In October 2018, Children’s National hosted 20 neonatologists from 15 hospitals in China for a 10 day Quality Improvement Leadership Training Course focused on quality improvement principles and methodology. The course also featured presentations on hospital-wide quality improvement work and included speakers from the Quality & Safety Department, Nursing Quality, and the Neonatal Intensive Care Unit (NICU). The Performance Improvement team worked with the attendees on their own projects, such as reducing antibiotic use and increasing family-centered care in the NICU. The attendees then presented at the end of the course to their colleagues, as well as to five hospital presidents visiting from China.

Children’s National safety experts share strategies

Rahul Shah

Rahul Shah, M.D., Vice President and Chief Quality and Safety Officer at Children’s National Health System (CNHS), and his team joined pediatric quality and safety leaders from across the country in Orlando, Fla. for the Children’s Hospital Association’s 2017 Quality & Safety in Children’s Health Conference.

Earlier this month, Rahul Shah, M.D., Vice President and Chief Quality and Safety Officer at Children’s National Health System (CNHS), and his team joined pediatric quality and safety leaders from across the country in Orlando, Fla. for the Children’s Hospital Association’s 2017 Quality & Safety in Children’s Health Conference. Dr. Shah shared findings and strategies that have led Children’s National to be a leader in this field, and collaborated with peers to move the needle on pediatric safety in hospitals and improving the quality of care hospitals deliver.

Notable presentations from the Children’s National team included:

  • The Children’s National utilization of a safety culture survey called the Safety Attitude Questionnaire (SAQ), and the crucial role of ensuring leadership alignment in the survey process. Obtaining leadership buy-in and alignment allowed Children’s to accelerate the spread of identified opportunities for improvement within the organization.
  • The importance of an ongoing multi-disciplinary approach to care for psychiatry patients, a patient population that that continues to increase in American pediatric healthcare and requires innovative approaches. Children’s National team members emphasized the importance of training the hospital’s security teams and front-line caregivers in therapeutic interventions to seek optimal outcomes for patients, while respecting the complexity of their diagnoses.
  • How to drive reliability through apparent cause analyses. Kristen Crandall, Director of Patient Safety at Children’s National, shared examples of how to leverage data to effectively drive change in cause analyses. Cause analyses are fundamental tools for implementing improvement. The team highlighted the upcoming launch of a High Reliability Toolkit© developed at CNHS to ensure that action plans created from cause analyses are of adequate depth and sophistication to drive improvements.

Dr. Shah and his team also had the honor of delivering an Impact session on the final day of the conference, in which they discussed the applications of merging patient safety with patient experience. The team also shared the Children’s National approach to safety and service, which includes delivering a unified framework of high reliability through consistent messaging to demonstrate that when safety and service integrate and align, the sum is greater than the parts.