BRIDGING THE GAP: ENSURING QUALITY ASSURANCE, REGULATORY COMPLIANCE, AND DATA INTEGRATION IN DECENTRALIZED HOSPITAL TESTING UNITS

Abstract

Background: Decentralized hospital testing has become an integral component of healthcare delivery by providing rapid diagnostic information at the point of patient care. But maintaining a consistent quality assurance, regulatory compliance and electronic data integration within a decentralized testing units is still difficult. Poor quality monitoring, staff skills, and information systems interoperability can impact diagnostic accuracy and patient safety. Objective: To assess quality assurance practices, regulatory compliance, and data integration among decentralized hospital testing units and examine their associations with operational performance. Materials and Methods: The study was conducted as an analytical cross sectional study in Armed Forces Institute of Pathology (AFIP), Rawalpindi, Pakistan over the period of January 2023 to August 2024 in 77 decentralized hospital testing units (DHTUs). The quality assurance indicators were standard operating procedures, internal quality control, external quality assessment, equipment calibration, staff competency and documentation of corrective action. Structured assessment criteria was used to evaluate regulatory compliance and connectivity with laboratory information system. SPSS version 26 was used to analyze data. Categorical variables were presented by frequencies and percentages, associations between the categorical variables were calculated with Pearson's chi square test and statistical significance was set at p<0.05. Results: The analysis included 77 testing units, of which 49.4% met the higher quality assurance compliance category, 31.2% achieved high regulatory compliance, and 41.6% had automatic data integration. Regular staff competency assessment was associated with higher quality assurance compliance (65.2% versus 25.8%; p<0.001). Automatic data integration was associated with greater documentation completeness (84.4% versus 53.3%; p=0.005) and timely result availability (78.1% versus 37.8%; p<0.001). Conclusion: Effective quality assurance, regulatory oversight, personnel competency assessment, and electronic data integration are essential components of decentralized hospital testing services. Strengthening standardized quality management procedures and digital connectivity may contribute to improved documentation, diagnostic reliability, operational efficiency, and patient safety.