Bashir Farah 1*, Pole Lewa 1, Bernard Omondi 1, Omu Anzala 1 1 KAVI-Institute of Clinical Research (ICR), University of Nairobi, Assessment of the Temperature Monitoring Systems in Public Health Laboratories in Kenya BACKGROUND The monitoring of temperature sensitive areas to maintain a constant, regulated state of control for products affected by temperature changes is critical for proper medical laboratory operation from a quality perspective. Even though all labs strive to employ the best staff and use the best analyzers and equipment, the ultimate quality of laboratory services is equally dependent upon the integrity of the reagents and media used throughout the lab. All of the consumable reagents and control material used in the pre-analytic and analytic phases are sensitive to temperature extremes and fluctuations. Therefore, the manufacturers of these reagents specify tolerance ranges for their products, within which they warrant the efficacy and accuracy of those products. Failure to store these items within the designated temperature range, or using them to test specimens outside of the designated range significantly increases the risk of obtaining erroneous results. By monitoring temperature in accordance with the manufacturer’s instructions the laboratory protects the integrity of the materials. If temperature control is not maintained for reagents and specimens, then the laboratory cannot have confidence in the results obtained. The temperature monitoring systems of three Public health laboratories and one faith based laboratory were evaluated. The temperature was monitored manually using mercury thermometers (Fig 1) and staff took recorded temperatures manually on a paper log sheet at designated times during the day. One of the laboratories employed the use of maximum and minimum thermometers (Fig 2) Fig 1: Mercury thermometerFig 2: Maximum and Minimum thermometer 4/4 (100%) did not monitor the temperature electronically and used mercury thermometers. None of the thermometers used were traceable to National Institute of Standards and Technology (NIST). There was 4/4(100%) error observed for off-shift hours as temperatures were not monitored during weekends and public holidays and the overall transcription error was 40% for the past one year (Fig 4) Fig.4. Fig.4. Temperature Monitoring Log Fig 3: Electronic Temperature Monitoring The process of temperature monitoring has undergone tremendous technological advances in the last two decades. Older systems employed liquid thermometers (either mercury or spirit fluid) immersed in a liquid and staff took recorded temperatures manually on a paper log sheet at designated times during the day. These intermittent samples of temperature stability did not provide a comprehensive view of storage conditions during off-shifts and the process did little to prevent system failures or alert staff of such events. In addition, the logging process was subject to both measuring and transcription errors. Manual monitoring is labour-intensive and requires the lab staff to spend some time taking and recording temperature. Charts and logs need to be collected, reviewed, filed, and stored for future audits. The manual monitoring does not provide a comprehensive view of storage conditions during off-shifts and does not alert staff of any temperature excursions. It is therefore critical that public health laboratories invest in automated computerized systems that increases the accuracy by providing continuous monitoring, centralized data collection, and simplified reporting. As the technology matures and accreditation bodies revisit their existing guidelines and regulations, laboratories will rely more on continuous, positive monitoring for all our temperature sensitive materials. Ultimately, positive temperature monitoring helps ensure the highest quality patient care through accurate results and shortened turn-around times by reducing the need to prepare additional reagents and perform unnecessary QC and calibrations. While there are distinct costs involved in employing dedicated, medical-grade refrigeration equipment to seamlessly maintain tight temperature ranges, these are counter balanced by the benefits of always providing the best conditions for our reagents, controls and calibrators, patient samples, testing equipment, and the patients themselves. This project has been supported by the President's Emergency Plan for AIDS Relief (PEPFAR) through Center for Diseases Control and Prevention(CDC) under the terms of 5UGPS While this Abstract was supported by Grant/Cooperative Agreement Number 5UGPS from CDC. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC * Presenting author: Pole Lewa ) RESULTS RESULBAGTRESS METHODS INTRODUCTION RESULTRESS RESULTCONRECCSS RESULTRESS DISCUSSION CONCLUSION ACKNOWLDEGEMENT RESULTS METHOD