The U.S. Food and Drug Administration (FDA) awarded Synensys a research contract to conduct the study “Improving the Reliability, Interoperability, Agility, and Quality of Laboratory Data Exchanges using System Safety Engineering Methods” under an FDA Broad Agency Agreement (BAA). With over 13 billion laboratory tests performed across the U.S. each year, patients, providers, public health officials, and researchers depend on the reliable laboratory data to diagnose, treat, prevent, and manage disease especially during the COVID-19 pandemic.

Synensys and their project team including experts from the Massachusetts Institute of Technology, the University of Nebraska Medical Center, the College of American Pathologists, and Deloitte Consulting, LLP applied systems thinking to assess, measure, document, and analyze the safety and quality of the laboratory data ecosystem. Systems thinking is a holistic approach to analysis that focuses on the way that a system’s constituent parts interrelate and how they work within the context of larger systems. Among other benefits, systems thinking provides a new perspective of the complex human factors challenges associated with change and expands the choices available to create long-term solutions to chronic system problems.

This research provides a roadmap for designing the future state of the laboratory data ecosystem envisioned through the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) Collaborative Community to produce the safest, highest quality laboratory data outputs regardless of the laboratory setting. This research provides concrete recommendations aimed at enhancing laboratory system safety, improving data-driven decision-making, streamlining data curation, and increasing trust in laboratory results, system interoperability, public reporting, and future public health research.

Click here to read the Overview

Click here to read the Executive Summary

Click here to read the Full Report

The U.S. Air Force Medical Service (AFMS) was part of an extensive safety review of the Military Health System by the U.S. Secretary of Defense. During this review, although findings showed mostly average performance across the AFMS compared to similar civilian facilities, the Secretary determined that average was not sufficient for active duty, retired, and dependent stakeholders; instead, patients deserved better care – higher reliability, zero preventable harm, and safer, patient-centered outcomes.

Synensys provided direction, strategy, know-how, and highly skilled staff to reduce preventable patient harm by accelerating safety culture behavior changes, including high reliability training and coaching. Using robust patient safety and quality data, our team helped AFMS facilities increase reliability through continuous process improvement.

AFMS has implemented and sustained proactive patient safety behaviors and high reliability training resulting in a 70% reduction in preventable harm events in 5 years.

WellSpan York Perioperative Services had experienced high levels of staff turnover due to the COVID-19 pandemic and needed to retrain and reset their high reliability programming across their pre-op, intra-op, and post-op surgical settings. Their goals were to improve morale, resilience and their safety culture.

Synensys conducted an organizational assessment of team-based safety practices, integrated change management tools, and HRO principles. Synensys provided high reliability training for senior leaders, frontline trainers, and coaches. A redesigned safety dashboard was configured to better manage daily operational risk resulting in improved quality of care and increased patient safety.

Synensys partnered with WellSpan to develop a comprehensive system safety program for their largest hospital perioperative service line. 100% of their surgeons, nurses, residents, technicians, and anesthesia providers were trained despite COVID-19 surge operations. Key metrics show improving trends in patient and staff outcomes.

Patient experience across the VHA system varied by location. Leadership mandated a review of patient experience across a representative sample of inpatient and outpatient facilities, including patient flow, patient feedback, complaints management, scheduling, admissions, discharges, and patient-provider communication.

Synensys completed a review of system-wide patient experience including patient complaint and service recovery, patient feedback, and wayfinding, customer services, and information sharing. Synensys analyzed all existing patient feedback including patient experience surveys, complaints, and comments. Additionally, our team conducted site reviews to collect process data, service behaviors, teamwork, and communication practices. The assessment data was collected, analyzed, and reported using analytical dashboard tools to enhance leadership awareness, properly allocate resources, and improve decision-making related to continuous improvement.

Patient complaints were managed more efficiently, patient experience scores increased in facilities that implemented recommended best practices, patient flow systems were redesigned, and ineffective patient programs were modified or cancelled due to better monitoring and evaluation of desired patient outcomes.

Centers for Medicaid and Medicare Services (CMS) had implemented new mandates related to value-based purchasing, also known as pay for performance in quality and safety. The U.S. health system had high rates of healthcare-associated infections (HAIs). CMS set goals to reduce preventable patient harm events (“never events”) by 20% across the national health system.

Synensys provided innovative improvement programs, tools, methods, and evidence-based strategies based on the needs of over 300 hospitals across 6 improvement networks aimed at reducing preventable harm in diverse settings, including community hospitals, critical access hospitals, and academic medical centers. Programs included senior leadership toolkits, physician engagement systems, high reliability training, StoryCare® online simulation platform, data management, culture improvement guidance, and implementation support, including coaching and mentoring.

Harm across the board was reduced by 17% in 3 years. Improvements in patient safety resulted in 1.3 million fewer patient harm events, 50,000 lives saved, and $12 billion in health spending avoided across all participating hospitals.

The North Carolina Quality Center partnered with the Virginia Hospital Association in the southeastern US to reduce the incidence of preventable obstetrical-related patient harm by 20%. Across North Carolina and Virginia, their maternal/fetal mortality rates ranked 42nd and 32nd respectively to the other States.

Synensys provided monitoring and evaluation of teamwork and communication skills during critical event simulation drills with over 30 hospitals – teaching multidisciplinary practitioners the knowledge, skills, and attitudes necessary to support a local team simulation system to improve performance.

All obstetrical-related patient harm was reduced by more than 20% in the 3-year program, saving an estimated 150 patient lives. Obstetrical teams adopted a post C-section debriefing process that surfaced hundreds of small but significant system defects which were improved using Plan-Do-Check-Act rapid cycle improvement methods taught through the program. Perceptions of safety culture, teamwork, and communication all improved significantly through the program duration – continuing to improve two years after the program was implemented.