Patient Safety Center of Inquiry at VA Palo Alto Health Care System

The Patient Safety Center of Inquiry (PSCI) at VA Palo Alto Health Care System (VAPAHCS) was activated on April 1, 1999 and in order to serve the following goals:

• Pursue inquiry into patient safety issues as related to performance of health care practitioners as well as systemic and organizational factors within the health care industry.
• Provide expert advice and recommendations to the VAPAHCS concerning improvement of patient safety.
• To conduct research, develop and pilot projects to acquire new knowledge related to patient safety.
• To demonstrate the feasibility of new ways to improve safety.
• To disseminate knowledge acquired.
• To be a prime training site for instructors or facilitators to disseminate patient safety interventions developed or tested at the center.

PSCI will address six issue areas:

Summary of PSCI's Tracks of Activity

Track 1 - Theory of Organizational Safety

This track is directed by Dr David Gaba whose interest in this field begun under the aegis of a Robert Wood Johnson Grant. This track investigates the following issues:

• Epidemiology of patient injury or near misses due to errors in care

• Theory of organizational safety and high reliability organizations as applicable to health care

• The burden of proof for safety decisions

• Clinician work hours and fatigue

• Safety culture issues in the handling of mistakes by clinicians

• Event reporting and analysis systems in high hazard industries

• Tort litigation and its effects on safety and event reporting

• Theories of regulation in health care and high hazard industries

• Selection, training, certification, and recertification of personnel in high hazard industries

• History, development, and current status of the patient safety movement deals with the theoretical understanding of how patient safety is fostered or is thwarted by the organizational structures and processes of modern healthcare.

• Simulation-Based Training in Decision Making, Crisis Management, And Teamwork: will extend the proven techniques from simulation training in anesthesiology into other medical domains including "code teams" and Intensive Care Units. A later project in conjunction with the "Cultures of Safety in Health Care" area will be conducting simulation-based training of senior management personnel and quality managers concerning the response to catastrophic adverse clinical events. In addition to providing hands-on practice and debriefing in organizational learning from accidents or near-misses, these simulations will help to inoculate key executives with a gut understanding of the importance of organizational safety in the hospital setting.

• Effects of Sleep Deprivation and Fatigue on Patient Safety: will assess the effects of fatigue on daytime sleepiness of different types of clinicians (residents, experienced physicians, and nurses) and of individuals of different ages. In addition, the section will develop educational curricula to assist healthcare workers to manage their sleep/wake status for optimal patient (and personal) safety. Finally, this section will develop techniques to assist in determining the contribution of sleep deprivation to the occurrence of adverse patient outcomes.

• Cultures of Safety in Health Care: will develop and administer instruments measuring organizational and work group cultures and processes related to organizational safety and learning.

• Safety-related Event Reporting and Analysis: provides consultation on the Patient Safety Reporting System modeled directly from the NASA Aviation Safety Reporting System (ASRS).

• Safety of Human Subjects in Research: will consider emerging issues of human subjects safety including safety and regulatory concerns for novel surgical and minimally invasive procedures relative to safety and regulatory concerns in the therapeutic use of investigational and approved drugs.

• Human Factors of Medical Equipment: will examine the design and construction of display, controls, and user interfaces of medical equipment.

Track 2 - Teamwork and Simulation

The Teamwork and Simulation track is directed by Dr. Kevin Fish, Chief, Anesthesiology Service, VAPAHCS. Dr. Fish is one of the originators of simulation-based teamwork training, and a co-author of the textbook "Crisis Management in Anesthesiology". This track includes simulation-based crisis management training activities in the operating room (ACRM), intensive care unit (Improvement of Management of Patient Emergency Situations or IMPES, and the delivery room (Neo/CRM). This track will soon include other activities related to management of patient trauma and emergency medicine and surgery.

Track 3 - Fatigue Effects on Clinicians

This track is directed by Dr. Steve Howard and it investigates issues related to fatigue of health care practitioners and its impact on patient safety. Dr. Howard is a leading expert in this field and has conducted previous studies on fatigue of anesthesia providers in the operating room. Currently Dr. Howard is collaborating with the departments of surgery, emergency and internal medicines, and nursing to establish fatigue measurement tools and recommendations for improving health care providers' rest conditions in order to optimize patient safety.

Track 4 - Cultures of Safety

This track is directed by Dr Gaba and is being lead by Kim Park, RN, from Quality Management at the VAPAHCS. A new survey instrument on cultures of safety was developed, combining elements from four pre-existing surveys to capture elements of assessing cultures of safety in the health care industry.

Using this instrument, a survey at the VAPAHCS, at other VA facilities in VISN 21, and in other VISNs was conducted. This survey will investigate the following hypotheses:

• Do VA personnel answer questions in a way that suggests that there is a culture of safety? That is, how do they compare either to "expected" norms for these questions, or to the published responses to similar or identical questions by workers in other industries?

• Do VA personnel differ in their views depending on their sub-group in terms of job type or work setting?

• Do VA personnel in matched sub-groups respond differently in different VA facilities? Within the same VISN? In different VISNs?. Do VA personnel in matched sub-groups respond differently than those in private facilities?

• What demographic or other factors account for differences in response concerning cultures of safety?

• Do the responses change over time? Are there shifts in safety cultures due to: national trends; local trends; specific training programs.

Track 5 - Event Reporting and Analysis

Dr. Gaba has conducted a large review of existing reporting systems in health care and in other high-hazard industries, and of the key issues governing the success or failure of such systems. Dr. Gaba and PSCI's investigators serve as consultants on the VHA pilot project to create a Patient Safety Reporting System (PSRS) analogous to the Aviation Safety Reporting System run by NASA for the FAA.

Track 6 - Protection of the Safety of Human Subjects in Research

Recent developments at West LA VA and Duke University as well as reports of the National Bioethics Advisory Committee have focused increasing attention and concern on the protection of the safety of human research subjects. This area has not been considered previously a priority of patient safety research or intervention. In this track, the PSCI at VAPAHCS has a unique opportunity to incorporate these emerging concerns into the framework of organizational safety and the patient safety movement due to the fact that the PSCI Director, Dr. Gaba, also chairs one of two IRBs covering medical research at VAPAHCS and Stanford University.

The connections between protection of research subjects and patient safety in general are important: on the one hand, it offers lessons from the philosophy and processes put in place to protect research subjects; on the other hand, the safety of research subjects needs to be viewed relative to the safety of patients as a whole. Emerging issues being explored by PSCI include:

• Safety and regulatory concerns for novel surgical and minimally invasive procedures relative to safety and regulatory concerns in the therapeutic use of investigational and approved drugs.

• Safety of subjects and patients in vulnerable populations.