Any safety considerations and precautions that can be controlled at the system level are included in the design of the system. Some potential risks require that the lab automation system follow a specific protocol when interacting with the system. Other potential risks relate to the lab automation system itself. The following considerations are vital to enhance the safety and reliability of Ortho Clinical Diagnostics’s systems and the automation systems to which they connect:
• Patient safety • Operator safety • Environmental safety
Automation vendors understand the need for strict compliance with system protocols. Lab automation system designers are strongly encouraged to consider these possible risks when designing interfaces between these products. If the system is used in a manner not specified by Ortho Clinical Diagnostics, the protection provided by the equipment may be impaired. Risks that are strictly controlled within the system and that were considered during the system's design are not shown below.
Patient Safety Considerations
Potential Risk Potential Result Recommended Preventive Action Contamination from the
chemical cleaning agent
Contamination or degradation of sample
Refer to the Reference Guide for cleaning agents and protocol. See the onboard V- Docs for VITROS® 4600 System or Reference Guide, J39821 on the CD-ROM. Particulate
contamination of sample on the automation track
Contamination or degradation of sample
Remove the stopper from sample tubes as close to the system as possible to maintain sample quality.
For any volatile assays, evaporation or out- gassing while the sample tube is on the automation track
Degradation of sample
Remove the stopper from sample tubes as close to system as possible to maintain sample quality.
Cross contamination from adjacent sample on the automation track
Contamination or degradation of sample
Set up automation systems to handle samples in a manner that prevents cross contamination.
Sample cross- contamination - Aspirating second fluid quantity into same tip (“double dip”) when the sample on track has been released too early and next sample is in position.
Cross-
contamination of sample on track
Make sure that LAS receives a SAMPLE COMPLETE message from the system before releasing the sample. Refer to Sample Metering Handshaking on page 23.
Sample too cold after holding in refrigerated section of track for reflex testing. (Automation track supplier controls temperature)
Sample temperature outside system limits
Provide a means of sample temperature equilibration to room temperature after refrigeration before the sample is presented for metering at the system.
Misalignment of automation track with the system.
Sample aspirate volume error
Follow specifications for sample tube location specified in Sample Center Device Adjustments: Positioning Responsibilities on page 46.
EMI from automation track to the system via coupling.
Sample aspirate volume error
• Ensure that automation track meets agency specifications.
• Isolate the mechanical coupling between the sample automation track and the system to address potential EMI concerns. Over-wet sample tip or
aspiration of air because the tube diameter information from automation system is incorrect.
Sample aspirate volume error
• Use error checking communication protocol (CRC).
• Follow communications specifications in Section 2. Software Interfaces.
Sample tube breaks at automation track and the system interface.
System
synchronization or timing error
• Refer to acceptable sample tube sizes for the specified in Section 4. Sample Handling.
• Design the detection of the sample tube height into the sample track.
• Detect time-out of sample metering subsystem and communicate error to LAS/ LIS.
Communication error between the system and the LAS.
System
synchronization/ timing error
Follow communications specifications in Section 2. Software Interfaces.
Incorrect sample presented to the system.
Aspirate from incorrect sample
Ensure the integrity of the sample ID communicated to the system and positioning of that sample. Sample ID mis-
communicated from LAS.
Aspirate from incorrect sample
Verify sample ID in the SAMPLE COMPLETE message sent to LAS. Automation track
system misreads the sample tube/carrier barcode.
Aspirate from incorrect sample
Use barcode verification for labels (i.e., check digit) and limit the scanner view to one sample.
Operator Considerations
Inadequate
consumables (reagents, tips, etc.) on the system to complete the test.
Test not completed
• Send system resource inventory to LIS upon request.
• Verify adequate supplies by LAS via LIS. If the supplies are inadequate, have the LAS reroute the sample to another system. STAT sample on the
track is unknown to the system. (All samples on the system have priority over samples on the track.)
A STAT sample on the track may not be processed in a timely fashion
Place STAT samples on the system manually and process as locally loaded samples.
Sample tube arrives with stopper inserted in tube.
Test not executed
Remove stoppers (caps) from sample tubes to allow the system to access the tubes. Remove caps when the tubes are as close to the system as possible to ensure sample quality.
Sample Metering general error report is interpreted incorrectly by the LAS.
Test not completed
• Use error checking communication protocol (CRC).
• Use message formats specified in Section 2. Software Interfaces.
Inactive subsystem(s) on the system.
Test not completed
Have the LAS verify the system status before the sample arrives.
Software suppressed results (due to a detected error) for a STAT test.
Test not
completed within expected time
• Place STAT samples on the system manually and process as locally loaded samples.
• Verify the system status and condition reports by LAS/LIS
Potential Risk Potential Result Recommended Preventive Action Electric shock at
automation track-to- system coupling.
Electrical hazards
Make sure that track is properly grounded. Potential Risk Potential Result Recommended Preventive Action
Environmental Considerations
Potential Risk Potential Result Recommended Preventive Action Metering proboscis
stuck in sample tube on track when sample is released by the automation system
Mechanical damage to sample track area and system
• Initialize sample metering subsystem by LAS if it receives a SAMPLE COMPLETE message combined with a sample metering error message from the system. • Do not move the sample from metering
position until the LAS receives a SAMPLE COMPLETE status without an error message from the system.
Ortho-Clinical Diagnostics Johnson & Johnson
50 - 100 Holmers Farm Way High Wycombe
Buckinghamshire HP12 4DP United Kingdom