Management strategy study on lyophilizing thrombin powder based on failure mode and effect analysis

Objective To explore the application of failure mode and effect analysis (FMEA) in improving the management strategies of high alert medication (HAM), such as lyophilizing thrombin powder. Methods The study groups on medication risk and its prevention strategies of lyophilizing thrombin powder were set up in China-Japan Friendship Hospital and Xuanwu Hospital, Capital Medical University, respectively. The possible failure modes appearing in clinical application of lyophilizing thrombin powder were collected by questionnaire survey and on-the-spot investigation. The risk priority number (RPN) scores were calculated according to the score results of severity, frequency of occurrence, and likelihood of detection. Failure modes with higher RPN scores were screened out and the corresponding prevention strategies were formulated. The situations in related links before and after improvement of the strategies were analyzed comparatively. Results The results from questionnaire survey and on-the-spot investigation showed a total of 37 failure modes in the links of information system, physician prescription, drug dispensing, medical order execution by nurses, and medication error reporting. Ranking the RPN scores from high to low, 15 major failure modes were screened out, including 4 modes in information system link (not setting the lyophilizing thrombin powder administration route as " oral" , lack of HAM labels, lack of photo library of confusing drugs, and lack of real-time reporting program of medication errors), 2 modes in physician prescription link (existence of confusing drugs and physician prescription errors), 4 modes in drug dispensing link (lack of prescription/medication orders auditing by pharmacist, absence of the pharmacist′s double check in drug dispensing and distributing, lack of location mark of HAM and confusing drug for lyophilizing thrombin powder in the pharmacy, and no special storage area for lyophilizing thrombin powder in the pharmacy), 4 modes in the link of medical order execution by nurses (negligence in check of the administration route of lyophilizing thrombin powder, existence of nurses in ward who were unfamiliar with the drug knowledge, no double check in drug distribution, and lack of location mark of HAM and confusing drugs in the ward), and 1 mode in medication error reporting link (no real-time information sharing system for medication errors among different wards). After drawing up the improvement measures of management, no medication errors occurred during the lyophilizing thrombin powder application in the 2 hospitals. Before and after the improvements, the percentages of physicians, pharmacists and nurses knowing that lyophilizing thrombin powder package should be with a special mark were 33.3% (12/36) and 83.3% (30/36), and the percentages of those knowing the right route to report medication errors were 77.8% (28/36) and 100% (36/36), respectively, with statistically significant differences (P<0.05 for both). Conclusions FMEA method can be used to screen the failure modes during the lyophilizing thrombin powder application effectively. The improvement of management measures for lyophilizing thrombin powder application has a positive effect on the improvement of medication safety. Key words: Healthcare failure mode and effects analysis; Thrombin; Hospital administration; High-alert medication