FROM SPECIMEN TO DISPENSE: MEASURING SAFETY BREAKPOINTS ACROSS LABORATORY, PHARMACY, AND MEDICAL DEVICES IN RIYADHA Cross-Sectional Mixed Audit

Abstract

Background: Patient safety within healthcare systems depends on the reliable performance of multiple interconnected domains, including clinical laboratories, hospital pharmacies, and medical devices. In Riyadh, Saudi Arabia's capital and most densely populated healthcare hub, systematic cross-domain safety auditing remains limited. This study was designed to measure safety breakpoints — operationally defined as indicators falling below established performance thresholds — across the laboratory specimen pathway, the pharmaceutical dispensing process, and the medical device lifecycle at multiple facility types in Riyadh.

Methods: A cross-sectional mixed audit was conducted at 21 healthcare facilities in Riyadh, comprising public hospitals, private hospitals, and specialist clinics. A total of 420 structured audit observations were collected (Laboratory: n=160, Pharmacy: n=140, Medical Devices: n=120) between January and September 2024. Each domain was assessed using six validated safety indicators, generating a composite overall safety score (0–100). Data were analyzed using descriptive statistics, one-way ANOVA, pairwise t-tests, chi-square tests, and logistic regression. Significance was set at p<0.05.

Results: Mean overall safety scores were 64.8 (±13.4) for Laboratory, 68.6 (±12.0) for Pharmacy, and 66.7 (±13.9) for Medical Devices (one-way ANOVA: F=3.208, p=0.041). Critical breakpoints were identified: hemolysis detection (23.1%), patient counselling compliance (49.3%), incident reporting culture in devices (48.3%), and calibration currency (57.5%). No domain achieved the pre-defined 80% safety target across all indicators. Private hospitals demonstrated marginally higher compliance than public hospitals, though differences were not statistically significant in most indicators. Logistic regression confirmed that hemolysis detection failure (OR=4.21, 95% CI: 2.45–7.23, p=0.001), cold chain non-compliance (OR=2.87), and absence of incident reporting (OR=2.53) were the strongest independent predictors of overall safety failure.

Conclusion: Significant safety breakpoints persist across laboratory, pharmacy, and medical device domains in Riyadh healthcare facilities. Targeted interventions addressing specimen quality management, cold chain infrastructure, medication counselling, and device incident reporting are urgently needed. Integration of cross-domain safety auditing within national accreditation frameworks is recommended.