Establishing Trust in Pharmaceutical Data with an Independent Verification and Validation Methodology.

Our aim is to demonstrate a general-purpose data and knowledge validation approach that enables reproducible metrics for data and knowledge quality and safety. We researched widely accepted statistical process control methods from high-quality, high-safety industries and applied them to pharmacy prescription data being migrated between EHRs. Natural language medication instructions from prescriptions were independently categorized by two terminologists as a first step toward encoding those medication instructions using standardized terminology. Overall, the weighted average of medication instructions that were matched by reviewers was 43%, with strong agreement between reviewers for short instructions (K=0.82) and long instructions (K=0.85), and moderate agreement for medium instructions (K=0.61). Category definitions will be refined in future work to mitigate discrepancies. We recommend incorporating appropriate statistical tests, such as evaluating inter-rater and intra-rater reliability and bivariate comparison of reviewer agreement over an adequate statistical sample, when developing benchmarks for health data and knowledge quality and safety.

My copilot is a nurse--using crew resource management in the OR.

Crew resource management (CRM) has been used for more than 20 years in the aviation industry to teach individual error countermeasures by developing nontechnical (ie, cognitive, social) skills based on the observed traits of successful individuals and crews. The health care industry began to investigate aviation CRM after the Institute of Medicine's report, To Err is Human: Building a Safer Health System, recommended that medicine adopt aviation's approach to safety and error management. Initial results of implementing CRM in health care arenas have demonstrated reduced adverse outcomes, reduced errors, reduced length of stay, improved nurse retention, and changed attitudes and behaviors toward teamwork.

Creating a systems approach to patient safety through better teamwork.

Using a systems engineering approach for the delivery of safe, reliable, consistently high quality healthcare is possible, based on the successes in other industries. To realize the level of reengineering required in healthcare, teams must function across disciplines and departments as a unified organization. By creating and maintaining HRTs, existing hierarchies will flatten and HROs will become part of the healthcare delivery system. The organization must support these teams with the proper tools, technology, and culture in order for the HRTs to complete their patient care missions successfully, consistently, efficiently, and most of all, safely. Government/compliance agencies must partner with organizations for the systems engineering approach to succeed in healthcare, so that policy ultimately originates from the consumer/patient through the care team and the organization, as opposed to a top-down mandate.