Clinical Quality and Safety in Adult Cardiac Surgery

National Landscape for Quality and Safety

In addition to quality and safety initiatives specific to cardiac surgery, a major cultural change has occurred in the United States during the early 21st century. Leadership in the prioritization of quality and safety has come from the Institute of Medicine (IOM). In a groundbreaking publication in 1999, “To Err Is Human,” the IOM made several important contributions. First, the report estimated that up to 98,000 patients each year die as a result of medical error. They identified that errors are often caused by faulty systems, processes, and conditions. They cited the work of Lucian Leape and colleagues, who codified four types of errors: diagnostic, treatment, preventive, and other ( Box 66-1 ).

To achieve a better safety record, the IOM report recommended a four-tiered approach:

• 1

  Establishing a national focus to create leadership, research, tools, and protocols to enhance the knowledge base about safety

• 2

  Identifying and learning from errors by developing a nationwide public mandatory reporting system and by encouraging health care organizations and practitioners to develop and participate in voluntary reporting systems

• 3

  Raising performance standards and expectations of improvements in safety through the actions of oversight organizations, professional groups, and group purchasers of health care

• 4

  Implementing safety systems in health care organizations to ensure safe practices at the delivery level (i.e., a culture of safety)

Two years later, the IOM published another landmark report, “Crossing the Quality Chasm,” which set a national agenda aimed at narrowing differences in quality among providers of medical care. Instead of focusing attention on a single outcome, the IOM focused on the quality of the entire patient experience, defining it in six key dimensions as being “safe, effective, efficient, timely, patient-centered, and equitable.” The model promulgated a balanced approach to assessment of quality, incorporating clinical outcomes with patient experience and the appropriate allocation of resources. Furthermore, the report identified key redesign imperatives for care delivery:

• Reengineered care processes

• Effective use of information technologies

• Knowledge and skills management

• Development of effective teams

• Coordination of care across patients—conditions, services, sites of care—over time

One other key focus of this IOM report addresses patient engagement:

• Care is based on continuous healing relationships.

• Care is customized according to patient needs and values.

• Patient is the source of control.

• Knowledge is shared and information flows freely.

• Transparency is necessary.

• Needs are anticipated.

These two IOM reports raised the bar to a new level of excellence that transcended the expertise of a single care provider. In 2006, a third IOM report, “Performance Measurement: Accelerating Improvement,” laid the groundwork for performance measurement. Achieving excellence now required a careful orchestration of care delivery, incorporating evidence-based care processes, as well as coordinated care infrastructure across the care delivery continuum—both inpatient and outpatient. Hardwiring for excellence became a priority, leading the Joint Commission (formerly known as JCAHO) to begin requiring demonstration of evidence-based and safe practices in the delivery of care. Payers and purchasers followed suit. The Centers for Medicare and Medicaid Services (CMS) instituted the requirement for submission of “core measures,” evidence-based practices in the care of patients with acute myocardial infarction, heart failure, pneumonia, and selected surgeries (including cardiac surgery).

Another key player has been the National Quality Forum (NQF), a public-private partnership created to develop and implement a national strategy for health care quality measurement and reporting. NQF member organizations have worked together to promote a common approach to measuring health care quality and fostering system-wide capacity for quality improvement. Yet another influence has come from the Leapfrog Group, an association of private and public sector group purchasers, who have created a market-based strategy to improve safety and quality. Their public ranking includes recognition for the use of computerized provider order entry, evidence-based hospital referrals, and the staffing of intensive care units with physicians credentialed in critical care medicine. In addition, they generate an aggregate Safety Score (A through F) for each hospital based on these data.

An outcome of these various national initiatives is the standardization of surgical care. Postoperative complications have a significant impact on mortality, length of stay (3 to 11 days), and cost. In a study of Medicare beneficiaries in 2009, surgical patients had a 30-day readmission rate of 12.7%. To decrease readmissions, CMS began reporting 30-day readmission rates for certain diagnoses in 2009. In October 2012, CMS began a pay-for-performance program in which hospitals with excessive readmissions for particular reportable medical diagnoses are penalized. The goal of the pay-for-performance program set forth by CMS and the secretary of Health and Human Services was to reduce readmissions by 20% by the end of 2013, and 18.5% reduction was achieved in 2012.

In 2002, CMS, in collaboration with the Centers for Disease Control and Prevention, implemented the National Surgical Infection Prevention Project with the goal of decreasing the morbidity and mortality rates associated with postoperative surgical site infections by promoting appropriate selection and timing of prophylactic antimicrobials. In April 2003, this group joined with representatives of the VA, American College of Surgeons, American Society of Anesthesiologists, Agency for Healthcare Research and Quality, American Hospital Association, and Institute for Healthcare Improvement to align efforts to reduce surgical complications and mortality. This collaboration resulted in the development of the Surgical Care Improvement Project (SCIP), a national quality partnership of organizations committed to improving the safety of surgical care through the reduction of postoperative complications. The rapid rate of adoption of the SCIP measures can be tracked on the CMS website Hospital Compare ( www.hospitalcompare.hhs.gov ), showing rates of compliance with these measures in hospitals across the country.

Evolving Landscape of Quality and Safety in Cardiac Surgery

From 1989 to 2007, the STS database grew to become the largest and most comprehensive single-specialty clinical database in health care in the world. In view of the increasing interest of payers and regulators to compare cardiac surgery quality, the STS established a Quality Measurement Task Force (QMTF). The task force's goal was to develop a methodology for comprehensive assessment of adult cardiac surgery quality of care. The assessment was to include both individual measures and a composite quality score. Guiding principles included the following :

• Quality assessment should be at the level of the program or hospital, rather than the individual surgeon.

• Initial quality reports should focus on CABG surgery.

• Quality measures should be chosen from among those endorsed by the National Quality Forum.

• Quality measure selection should be consistent with the principles and criteria recommended in the 2006 IOM report “Performance Measurement: Accelerating Improvement.”

• Quality measures should be available as data elements in the STS National Adult Cardiac Surgery Database.

• Quality scores should take into account structure, process, and outcomes.

• Quality scores should assess three temporal domains—preoperative, operative, and postoperative.

• Quality scores should satisfy multiple criteria for validity.

• Quality scores should be interpretable and actionable by providers.

In 2007, the STS QMTF created 11 measures within four domains: perioperative medical care, intraoperative care, risk-adjusted operative mortality, and postoperative morbidity. Statistical analysis was based on actual 2004 STS data, representing 133,149 coronary artery bypass procedures. The STS QMTF measures are listed in Box 66-2 .