Interface of Analyzers and Diagnostic Systems
The interface of automated analyzers with the Laboratory Information System (LIS) is the basis of modern laboratory automation. It allows the fast and secure transfer of data from the information system to the analysers, regarding which tests they should perform on which sample, and then the return of the results.
The interface is implemented through the ‘Dev-Connect’ software, which is a central server communications system for the exchange of messages between the analyzers and the LIS. It allows the remote connection, monitoring and management of the analyzers’ data and achieves their integration into the ‘MediLab LIS’ information system.
The system offers easy, secure and transparent use. It aims to both reduce errors and improve the laboratory’s TAT (Turn Around Time). It offers fast access to information, by automating routine processes. More than 500 analyzer communication protocols have already been included in ‘Dev Connect’. See here an indicative list of connected Analyzers and Diagnostic Systems.
System functions and features.
- Interconnects analyzers and Diagnostic Systems with serial RS232 or Ethernet.
- Monitors all connected analyzers in real time.
- Offers remote connection of analyzers for troubleshooting.
- Validates patient information flow and QC data.
- Features simple management using profiles.
- Supports specialized interface protocols (HL7, ASTM, etc.).
- Includes extensive reports for sample, patient and quality control data.
- Notifies when an event occurs (alerts).
- Ensures connectivity with strict regulatory requirements.
- Offers easy “one-button” installation in the hospital environment through central management.
- Features a single interface for multiple analyzers.
- Reduces connection and maintenance costs.
- Minimizes time between failures.
- It configures flexible connection.
- Supports status reports.
- Offers remote viewing and management.
- Has multilingual support capability.
- Improves quality and performance.
Analyzer Interface Details
The interface between Analyzers and the laboratory system is governed by the following general – basic elements that ultimately make up this interface.
Network Level
It concerns the means by which the analyzer is connected to the laboratory network. TCP/IP networking (Sockets), serial communication (RS-232), communication via Serial Servers and sometimes VLANs (Virtual LANs) are used.
Ethernet Ports (TCP/IP): The modern connection standard. It allows fast and secure data transfer via the local area network (LAN).
Serial Ports (RS-232): Communication via a serial port interface cable that is still used in certain analyzers. It is often addressed by using Serial-to-Ethernet converters (Device Servers) for their integration into the network.
Virtual LANs (VLANs): For security and interference prevention purposes, analyzers are isolated in a separate, protected subnet.
Software Layer & Communication Protocols
Defines the “language” and structure of the information exchanged between systems.
HL7 Protocol: Analysis of the structure of messages at the hospital system level (Segments: MSH, PID, ORC, OBR, OBX). The international standard for the movement of clinical and administrative data in healthcare. Uses strictly structured messages (segments) for demographics and results.
ASTM Protocol: Focuses on lightweight, text-based communication directly with hardware (H, P, O, R, L). Specialized standard (e.g., ASTM E1394) designed exclusively for the communication of clinical analyzers with information systems.
Middleware: A critical software layer that acts as a “translator” between the different analyzer drivers and the central LIS database.
Data Workflow & Messaging Mechanisms
The interface is usually bidirectional and supports two basic processes:
Order Download / Host Query: The analyzer scans the sample barcode, sends a query to the LIS, and the LIS returns the tests to be performed (Query Mode). Alternatively, the LIS sends a Batch Worklist.
Result Upload: Once the measurements are complete, the analyzer sends the values, possibly the units of measurement (e.g., mg/dL), and any flags for limits or instrument errors to the LIS.
Use of “Rules Engine” for automatic Reflex Testing and other functions (re-execution of tests based on pathological values) and technical validation.
Data Flows Variations due to Unidirectional and Bidirectional Communication. Analysis of Real-Time Host Query and Batch Worklist Functions.
Identification & Mapping
Identification is necessary so that the communicating parties understand what is what despite different encodings
Barcoding: Use of Unique Sample ID to eliminate the human factor. The barcode on the tube is the unique sample ID. It ensures that the results will be registered to the correct patient.
Test Mapping Tables: Tables where LIS test codes (e.g., SGOT) are mapped to internal codes understood by the analyst (e.g., code 204) and other participating parties.
Quality Control: Automatic retrieval of Controls results, creation of Levey-Jennings plots, and application of Westgard rules.
Networking
Analyzers with RS232 to TCP
The interface via a “protocol converter” allows diagnostic instruments that do not have a direct network connection (TCP/IP) but only a serial port (RS232) to be interconnected to the Ethernet network of the Hospital or even to the Internet. In this way, the online ‘appearance’ of the Medical instrument is activated.
The solutions of the protocol converter can be:
a. Hardware devices (serial to Ethernet)
b. Software application running both at the server and at the client level (PC connected to the medical device, using a classic RS232 cable).
Information transmission via the Ethernet network
The software transfers the results from the automatic medical analyzers securely via the Network. Either of the two solutions achieves the connection of the equipment with a serial port RS232 to Ethernet, so that the device obtains an IP address (ethernet). The serial server is the best choice for asynchronous connection of the device with a serial COM port, in TCP socket based applications.
The use of RS232 to TCP converters on the one hand reduces the cost of the Organization and on the other hand allows the continued use of existing diagnostic systems, avoiding their immediate replacement. Therefore it reduces the ‘Total Cost of Ownership’ (TCO) and increases the ‘Return on Investment’ (ROI).
The ‘Serial to Ethernet’ type interface offers an upgrade of the use of diagnostic systems, in the software for the Interconnection of Analyzers and Diagnostic Instruments ‘Dev-Connect’ and is the optimal solution for analyzer interconnections.
In complex environments, both ease of use and connectivity of diagnostic systems are crucial.
The system offers easy, secure and transparent use. It aims to both reduce errors and improve the laboratory’s TAT (Turn Around Time). It offers fast access to information, by automating routine processes. More than 500 analyzer communication protocols have already been included in ‘Dev Connect’. See here an indicative list of connected Analyzers and Diagnostic Systems.
The System
CCS’s ability to complete complex and extensive Health Informatics projects ensures the continuous evolution of large organizations.
Data Security
Protecting Sensitive Health Data
The data exchanged between analysers and LIS is sensitive personal health data. Its protection is strictly defined by the European GDPR Regulation.
Encryption Strategies
Encryption in Transit: Traditional HL7/ASTM communication over a simple TCP Socket is plain text. Anyone with access to the local network with a Network Sniffing tool (e.g. Wireshark) can read patient names and results.
HL7 over TLS (Lower Layer Spring Protocol – MLLPS): The modern approach requires the creation of encrypted channels (SSL/TLS) for the transfer of messages, ensuring that the information is unreadable in case of interception.
Role-Based Access Control (RBAC)
Middleware and LIS must restrict user privileges:
Laboratory Technologists have the right to perform tests, manage QC, and perform technical validation.
Physicians/Biopathologists have the exclusive right to clinical approval and modify results.
Biomedical/IT Engineers only have access to driver settings, mapping, and communication logs, without viewing medical history unless required.
Full Audit Trail
Every action performed on the interface system is permanently recorded in an unmodifiable database (Audit Log).
What is recorded: Which user sent the command, when the result was received from the instrument, if a manual change (Manual Edit) was made to a value, who made the change, what the original value was, and who gave final approval.
The connection may fail for various reasons. Quick resolution is based on the analysis of Raw Logs.
Common Errors and Troubleshooting
Timeout Errors: The analyzer does not respond to the LIS within the specified time (e.g. 5 seconds).
Cause: Network cable disconnection, IP change, or driver service crash.
Checksum Errors: Data arrives corrupted.
Cause: Electromagnetic noise on RS-232 serial cables without adequate shielding.
Unknown Test Codes: The analyzer sends a result, but the LIS rejects it.
Reason: Failure to update the Mapping Table after introducing a new test to the laboratory.
Compliance with ISO 15189
ISO 15189 (Clinical Laboratory Accreditation) sets strict rules for information management.
The interface must support:
Software Validation: Before commissioning, it must be proven with documented test cases that the Middleware transfers values with 100% accuracy, without rounding or digit distortion.
Downstream / Fallback Procedures: Existence of a written procedure for how the laboratory operates if the network or LIS goes down (e.g. turning the analyzers into local manual mode and manually recording results on special forms).
A constantly evolving process
The interconnection of analyzers in a LIS is not a static technical implementation, but a constantly evolving process. The current trend is moving from the traditional HL7 v2 and ASTM protocols towards HL7 FHIR (Fast Healthcare Interoperability Resources), which is based on RESTful APIs and JSON/XML technologies, allowing the interconnection of analyzers directly with Cloud systems and Artificial Intelligence (AI) platforms for advanced predictive diagnostics. Proper architecture, network security, smart Middleware and accurate Test Mapping are the pillars for a secure, efficient and certified interconnection system like ‘Dev Connect’.
