Perioperative and Anesthetic Adverse Events in Thailand (PAAd Thai) incident reporting study: hospital characteristics and methods

A multicenter observational study was prospectively conducted in 22 hospitals across Thailand (Figure 1) during a period from January through December, 2015 (Figure 2). The hospitals were chosen among hospitals previously involved in the Thai Anesthesia Incident Monitoring Study (Thai AIMS) [6, 7], based on their agreement to participate in reporting the adverse events anonymously.

Figure 1

Figure 2

The protocol for this study was adapted from the previous study protocol [6] and approved by each institutional ethics committee (institutional review board) before starting data collection. An incident reporting form (a case record form) was revised and its content was validated by an expert committee, which included experienced anesthesiologists from the participating hospitals. A standardized incident reporting form was completed by anesthesiologists or nurse anesthetists from each participating hospital as soon as possible after episodes of adverse or undesirable events, as defined on the last page of the form, occurring within 24 h of anesthesia and operation. Details of the adverse events were described regarding “what happened”, “where it happened”, “when it happened”, “how it was detected”, “why it happened”, “how it was managed”, and “what were the results” in both closed-end and open-ended questionnaires. Data regarding patient factors (such as age, sex, body weight, and height, American Society of Anesthesiologists physical status), surgical factors (such as types and sites of operation), anesthetic factors (such as types of anesthetics, airways, and monitors), and systematic factors (such as elective vs emergency conditions, out patients vs in patients, official vs nonofficial working hours, level and experience of anesthesia care providers, and information regarding participation in surgical safety checklists) were recorded. Moreover, subsections for “factors contributing to the incident”, “factors minimizing the incident”, and “suggested corrective strategies” were addressed. Several workshops were organized for participants in the study. The workshops provided instructions regarding how to detect and report the incident. The site managers played a role in “ensuring that the report forms were available in convenient locations”, “encouraging people to fill out the forms”, “providing a local forum for discussion of the incidents”, and “forwarding the completed forms to the data management center”. The completed forms were sent to the data management center at regular intervals. The name of patients and hospitals were confidentially kept in the logbook at each hospital involved. The completeness of each form was checked by the data management manager. The participating site was contacted directly by the data management center to complete and correct any missing or incorrect data. Despite the amendments, the original text and the alterations remained apparent to any future assessor. After checking and organizing, the data from the form was put onto the central computerized database for further retrieval and analyses.

In addition, each participating hospital submitted a cover letter along with the hospital characteristics regarding type (university or academic directed vs nonuniversity or medical service directed hospitals), size (number of beds), and location of the hospital. Details about the number of operating theaters (rooms) and number of anesthesia providers and assistants were noted.

Subsequently, the completed record forms of each interesting adverse event were distributed to at least 3 peer reviewers to independently identify the incident mechanism, contributory factors, and appropriate management and preventive strategies. Any disagreement was critically discussed and judged to achieve a consensus. The descriptive statistics were used to summarize the data by using SPSS for Windows, version 22 (IBM Corp, Armonk, NY, USA).

In an effort to improve patient safety, hospitals have been encouraged to report a “patient safety incident”, which is defined as “an event during an episode of patient care that has the potential to or causes injury or harm to patients” [4]. Anesthesiology is a medical specialty that aims to provide anesthetic care in a safe environment for surgical and medical procedures. Based on a previous model of incident reporting of anesthetic adverse events in Thailand [6], we developed an incident report form to encourage the participating hospitals across Thailand to capture and report perioperative adverse events related to either anesthesia or surgery in order to create an open environment among hospitals for learning together regarding the anonymously reported incidents that may be either harmful or potentially harmful. This approach can enable an organization to learn from failures in the delivery of care for feedback of recommended actions to complete the loop of patient safety in a health care system [9]. A critical incident is a human error or an equipment failure that can lead to undesirable outcomes if it is uncorrected. Furthermore, an incident can also be related to failure in other nontechnical skills such as processes of communication, coordination between teams, and documentation [10].

According to George Bernard Shaw, “a life spent making mistakes is not only more honorable, but more useful than a life spent doing nothing.” We should accept that studying error is a normal process in order to establish systems to manage the risks. One should keep in mind that studying error is not to blame, but to ask “why” in order to ascertain causality for prevention [11].

Twenty-two hospitals including university or academic directed and nonuniversity or service-directed hospitals, participated in this multicenter study. Most of them were training hospitals for residents, medical students and nurses which may predispose to cause training associated adverse incidents. The subsequent study of training-associated adverse incidents will be meaningful to provide lessons that can be learned to provide patient safety in a training program.

Most of the service directed hospitals (11/13) had less than the desired number of anesthesiologists according to manpower management measures recommended by the Thai Ministry of Health. The shortage of qualified manpower could be a predisposing factor causing adverse incidents. Recently, performing surgical safety checklists has been encouraged across Thailand. Whether or not this strategy affects the adverse events has yet to be evaluated.

A critical incident analysis of each reported event will be performed and reported in subsequent sections of this study. Ultimately, a corrective or preventive strategy will be proposed to ameliorate perioperative care and improve patient safety in the Thai health care system.