Risk Evaluation of Point-of-Care Testing (POCT) Devices: Insights From a Tertiary Care Hospital

TL;DR

This paper evaluates risks in point-of-care testing devices in a hospital, identifying errors and suggesting improvements to ensure accurate and reliable results.

Contribution

A comprehensive risk assessment framework for POCT devices in a tertiary hospital, using FMEA to identify and mitigate errors across testing phases.

Findings

Key pre-analytical risks include inaccurate patient identification and clotted samples.

Analytical phase issues involve improper quality control and mishandled samples.

Post-analytical risks include reporting errors and delayed results, mitigated through training and automation.

Abstract

Introduction

Point-of-care testing (POCT) entails conducting a test near a patient, delivering rapid results outside the traditional laboratory setting. Even though point-of-care testing offers the advantage of rapid test results and enables quicker medical decisions, it also introduces unique risks of errors, raising concerns regarding the quality and reliability of these results. This study focuses on a comprehensive risk assessment of POCT devices in a tertiary care setting to evaluate performance, identify potential errors, categorize risks, and implement strategies to enhance their safety and effectiveness.

Method

The study was conducted as a prospective, observational, nonrandomized study in a tertiary care hospital. A total of 53 devices were selected purposively which were used across various departments of the hospital, including emergency, intensive care unit (ICU), critical care unit (CCU), operation theatre (OT), maternity, and obstetrics. The assessment covered a range of POCT devices: blood gas analyzers, cardiac biomarkers, coagulation analyzers, and glucometers. In POCT devices, risk assessment identifies potential hazards that may arise throughout the entire testing process, encompassing the pre-analytical, analytical, and post-analytical phases. Performance of the devices was evaluated using comparison with standard guidelines and errors were identified using direct observations and incident reports. The Failure Modes and Effect Analysis (FMEA) template served as a tool for on-site risk assessment, facilitating the systematic identification and evaluation of potential failure modes and their corresponding effects. A comparison of the scored risk priority number (RPN) before and after interventions was conducted to assess the effectiveness of the implemented suggestions or action plans for mitigating the identified risks.

Results

Inaccurate patient identification, clotted samples due to improper mixing, patient injury, and delays in sample transportation were the key risks identified during the pre-analytical phase. Delays in sample processing, improper handling of internal quality control materials, improper handling of external quality assessment scheme samples, failure to adhere to original equipment manufacturer instrument maintenance protocols, mishandling of patient samples, and inadequate quality checks were a few observations during the analytical phase. Reporting errors, delayed turnaround times (TAT), and delays in reporting panic values were observed during the post-analytical phase. Implementing quality control measures, real-time monitoring, automation, comprehensive staff training, and risk mitigation strategies served to enhance the reliability and efficiency of POCT devices.

Conclusion

In point-of-care testing devices, risk assessment identifies potential hazards that may arise throughout the entire testing process, encompassing the pre-analytical, analytical, and post-analytical phases. Continuous monitoring and improvement efforts are essential for adapting to evolving risks in POCT devices.