lss slas2015 presesentation 1.1

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Real Time Predictive Modeling of Clinical Samples in Transit to Ensure Sample Viability Jarie Bolander, Chief Operations Officer

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Achieving Six-Sigma Encompasses Pre-Analytical Sample Integrity in Transit

•  Multiple temperatures profiles = complexity •  Delayed delivery = spoiled samples •  Lost / non-delivery = resampling required

Driven by CAP, CLSI & ISO-15189

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Pre-Analytical Issues

Temperature noncompliance = uncertainty Misplaced samples = delays Compromised samples = inaccuracy Incomplete data = compliance issues

Regulatory pressures make resolution imperative

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Cumbersome barcode scanning Manually recorded temperature logs Misdelivery – wrong room / lab SOP violations Gaps in training

Manual Processes Confound Issues

The Solution

Automating sample quality assurance in

transit

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.01 Mobile Sensors used to determine temperature and location of totes / samples.

.02 Android/iPhone app captures information and sends to Cloud.

.03 Cloud based dashboard gives real time system health including temp, location and remediation.

.04 •  Administration •  Alerts and Remediation •  Predictive Analytics

•  No Special Infrastructure Required

Cloud Storage & Analytics

Bluetooth Low Energy

Cellular/WIFI

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Real Time Courier, Dashboard & Temperature

Courier phone warns

courier of problems

Web dashboard warns Lab of status and

issues in real time

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Sample Container Location

•  Continuous Monitoring Of Totes •  Geo-Location Centric to Important User Locations

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Temperature Monitoring

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Laboratory Case Study

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Real-Time System Health

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Dashboard

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Summary Report

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Tote Movement

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Dry Ice Replacement SOP Compliance

SOP: Add Dry Ice at Start of Shift. Empty at End of Shift

Shift

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Drive Pre-Analytical Six Sigma Quality Maintain sample temperature integrity Track and ensure sample delivery Confirm SOP & regulatory compliance

Define-Measure-Analyze-Improve-Control

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Do You Know Where Your Samples Are?

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Appendix For More information: Web: www.lsstracks.com Contract: forinfo@lsstrack.com 650.275.3101

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Abstract •  Clinical samples in transit are required to be maintained at precise temperatures to ensure

sample viability. Traditional methods for ensuring temperature stability of samples in transit have relied on labor intensive processes that cannot predict when samples may become unviable and furthermore, these traditional processes are error prone and inconsistent. We have developed a system and method to monitor the conditions of clinical samples as they get transported from a collection center to a core laboratory facility. This system, called T-Tracks™, allows laboratory staff to monitor the temperature a sample has been kept at and any reported transportation issues. The system also predicts when a sample container may go out of temperature compliance and sends a warning to laboratory staff. These predictive warnings allow staff to preempt any potential issues before the sample deteriorates. The system eliminates the manual process of recording the temperature of clinical sample containers while also allowing laboratory staff to be confident that their samples were held at the proper temperature during transportation. This confidence ensures that the tests performed on the collected samples are of the highest quality. The collected temperature and location data also allows the system to learn of potential hazards beforehand and warn staff to take preventive action. Such warnings are impossible with the common manual systems of temperature and location recording presently in use. The real time nature of the system gives laboratory staff the ability to plan the laboratory work load since bottlenecks can be identified based on conditions enroute to the laboratory.