A Comparative Study of Laboratory Protocol Deviations Across Pre-Analytical, Analytical, and Post-Analytical Phases in Public and Private Diagnostic Laboratories

Abstract

Background: Diagnostic laboratories are important to healthcare, providing critical information for diagnosis, treatment decisions, and patient monitoring. The reliability of laboratory results depends on maintaining quality at every phase of the testing process. Deviation from established laboratory protocols may arise during the pre-analytical, analytical, and post-analytical phases, thereby compromising the quality of laboratory services.

Methods: A multicenter cross-sectional observational study was conducted over a four-month period at designated public and private diagnostic laboratories. Five public laboratories and three private laboratories were integrated. Routine laboratory procedures were evaluated during morning shifts, five days a week, via direct observation utilizing a prepared checklist consistent with established laboratory standards. Observed deviations from standard protocols were noted across the pre-analytical, analytical, and post-analytical processes in the phlebotomy, hematology, clinical chemistry, microbiology, and clinical pathology departments. Data were evaluated descriptively using frequencies and percentages.

Results: Protocol deviations were more prevalent in public laboratories, especially during the pre-analytical phase. Pre-analytical variations accounted for almost 60% of the detected discrepancies in public laboratories, compared with 10% in private laboratories. Frequent discrepancies in public laboratories included inadequate compliance with phlebotomy protocols, limited use of appropriate specimen-collection materials, insufficient antiseptic measures, specimen-identification challenges, and nonadherence to standard operating procedures (SOPs), while in private laboratories, excellent efficiency had been observed in accurately use of sterile containers for sample collection, proper labelling, barcoding, and a standardized way of preparation and processing.

Conclusion: The pre-analytical phase is crucial and requires improvement, particularly in public laboratories. Strengthening conformity with SOPs, ensuring resource availability, and establishing rigorous quality monitoring may improve laboratory results and patient safety. 

Keywords: Diagnostic laboratories, protocol deviations, pre-analytical phases, public laboratories, private laboratories, Pakistan