Value Add

Labs go Hi-tech

In the context of massive databases, only a LIS delivers the analysed outcome with the click of a mouse

It is indeed no news that IT is making a slow but steady impact in healthcare. Labs are a significant witness to this transition phase and with the increasing demand for Laboratory Information Systems (LIS), many IT vendors are looking forward to cater to this segment. One such company that is making its presence felt in the LIS market is Syscon Infotech.

Syscon Infotech

Leveraging on experience and proficiency of varied healthcare professionals, Syscon Infotech has produced comprehensive and customised Laboratory Information Software- Solar. The software solutions from solar interlace cutting edge futuristic technology, thus a balance of pragmatism and feasibility. Focused on quality, user friendly attributes and innovative customisation, Solar is a watchful laboratory manager that upholds the standards of Good Laboratory Practices (GLP).

Syscon as an enterprise envisions product excellence in compliance with global ideology. The company mandates commitment and continued customer services thus propelling towards leadership in healthcare solutions. Syscon Infotech stems out of the Syscon Group of Companies that is headquartered at Bangalore.

Laboratory Information Systems

A LIS or a clinical laboratory information system is a category of software which operates information regarding clinical laboratory processes. A clinical LIS primarily controls processes involved in sample collection, receiving, processing, storing and reporting. In short, this is a tool that tracks all the information generated by the laboratory. The software system can often be integrated into other systems such as interfacing with laboratory instruments and or other information systems such as a Hospital Information System (HIS). An efficient LIS is configurable and facilitates a wide variety of laboratory work-flow processes. Customisation of LIS offers the extraordinary advantage of flexibility while catering to individual laboratory needs in compliance with set standards. LIS can be offered as a wholesome laboratory undertaking or as individual modules that accommodate specific aspects such as blood banking, serology, hematology, clinical pathology, biochemistry and microbiology.

Objectives

The key focus of an LIS is to maintain quality in the laboratory work flow processes. The LIS maintains uniformity in the laboratory processes in entirety. This also involves the use of controlled medical vocabulary. An LIS delivers quality along with prompt and accurate outcomes in the best turn-round-time and the most cost effective manner. High throughputs are maintained without quality compromises resulting in absolute precision. The element of manual error is almost zeroed by the use of an LIS. Ultimately, the LIS builds an online, real-time computerised patient record. The patient database with searchable information serves as an invaluable tool in perceiving trends in diagnosis and treatment.

Critical success factors: The success story of LIS lies in its deliverables. The foremost being quality that is mandated for a state-of-the-art healthcare setting. The secondary influencing factor is cost-effectiveness with high throughputs and in preserving the best turn-around time. It is evident that both these attributes, directly impact patient care, accuracy in diagnosis, treatment issues and ultimately patient satisfaction.

Total Quality Management- A glorified round-the-clock vigilant eye, LIS provides time checks in every step of the laboratory processes, thus ensuring Quality Assurance (QA). In laboratory medicine Total Quality Management (TQM) entails both Quality Controls (QC) for individual tests as well as QA. LIS nullifies manual interference; especially in areas of patient registration, pre-analytical and post-analytical processes, thus achieving its focus in enhancing the credibility of the laboratory.

Sample traceability: By a bar-coded system assists in sample tracking from the point of collection, sample processing up to result generation.

Validation, verification and certification: The other tool that is vital to the post-analytical processes is result validation, verification and certification. The LIS has the ability of validating a given test result. The same is verified and certified by authorised signatories of the laboratory before issue. The report issue itself can be halted, should the authorised signatory pose tabs in the LIS to withhold the dispatch of report without verification or validation.

Data Transference: Uni or bi-directional interfacing allows for data transference directly from the point of analysis to the report entry. In the conventional paper-based system, in the absence of stringent monitoring mechanisms that need to be inculcated into the laboratory medicine culture, errors in pre-analytical, post-analytical and sample processing are not uncommon.

Integrating a Standard Operating Procedure into the LIS: A Standard Operating Procedure (SOP) can be integrated into the LIS, thus irrespective of the individual, there will be regular checks built into the system. For instance, if the SOP for sample collection entails that all patient details are to be recorded before dispatch to the respective departments or sections, the LIS will indicate the failure in complying with the same. Stringency in protocol adherence is enhanced.

Documentation and Backup mechanisms: The guidelines for NABL/ NABH have made documentation a vital aspect for the accreditation process. It becomes mandatory for every sample entering the laboratory to be precisely documented. While a paper based system has no replacement, an electronic system that contains all the information will be an efficient method of storing data and records. Regular back-ups can be taken. Space concerning storage can also be reduced with an LIS.

Cost effectiveness: It is a misleading notion that an LIS compliments the duties of a clinical laboratory clerk or a data entry operator. The LIS stretches beyond, reducing risks of errors and enhancing quality. The LIS curtails lapses in a manual billing system, improves inventory and stock management and or supply chain protocol of the laboratory. The LIS has the ability to multi-task as well as mediate between various sections of the laboratory as well as the different departments in a hospital. The invasion of Information Technology has cropped into and gradually but effectively replaced a number of paper-based systems such as libraries, billing and accounting systems. It will not be long before the cost-effectiveness of LIS implementation becoming a proven factor.

Potentials

Clearly, the potentials outnumber the pitfalls.

Turn-round-time: An LIS maintains good turn-round time. Defined turn-round time periods can be pre-fixed and intimated to either the clinician or the patient or both. A drastic reduction in patient waiting time is observed when the time of report receiving is entered on the bill itself.

High throughputs: Maximal errors are in times of high workload periods or under-staffed shifts or in combination. An LIS has a control on work-flow pace and patterns. The LIS modules with built-in quality checks permits high throughput work flow in good turn-round time.

Auto- Validation, Verification and Certification: Apart from enhancing the quality in deliverables, the auto-validation, verification and certification asserts the authorisation of reports by designated signatories. This ensures that each report is appropriately assessed.

Bar-coding: Ascertains the sample being traced throughout the process.

Interfacing: A linkage in pre-analytical, analytical and post-analytical processes. Interfacing in conjunction with bar-coding is a complete laboratory solution as it complies with the best laboratory standards.

Delta check: Are methods for detection of random errors in clinical laboratory tests including specimen abnormalities, specimen mix-up, problems in analysis processes, and clerical errors. Multi-variate delta check methods are more superior to the univariate delta check methods.

Digital Signature: The use of digital signatures by authorised entry portals affixes significance to the laboratory report.

Graphics: Employs a novel technology for the computation, data analysis, integration and management, modeling of reactions such as the interaction of protein-ligand, protein-protein and other bio-molecular systems.

Audit Trial: Is a record of transactions that provides verification of the activity of the system. For instance, if a person's salary is increased, the change transaction includes the date, amount of raise and name of authorising manager. A more elaborate audit trail can be created when the system is being verified for accuracy and the samples of processing results can be recorded at various stages. Item counts and hash totals are used to verify that all input has been processed through the system.

Data Mining: Data mining, a concept that is rapidly gaining pace, is sorting and extraction of relevant information from a large database. The magnitude of the databases may surpass manual calculation and thus electronic interventions in the form of bioinformatics assist in making use of the data collected.

Web-enabled Services: Web services integrated into LIMS modules, assist in establishment of web services framework. The web services framework makes available key LIMS elements such as sample tracking, results entry, and a variety of quality-related information for distribution to other systems. These services are made available to enterprise-software, running procurement, logistics, human resources, regulatory reporting and or other processes.

Radio Frequency Identification (RFID): Monitoring high level event detection, the RFID utilises radio labels that are tagged to the sample (similar to bar coding). Advancement over conventional bar coding, RFID is well suited for massive databases.

Data Privacy: Privacy and confidentiality of patient information is an institutional obligation. The nine principles to prevent infringement of personal data that are incorporated into the LIS are assess control, record opening, and control of patient entries, consent and notification, control over record viewership, attribution, information inflow, aggregation control and trusted computing base.

Knowledge Management to Support Performance Based Medicine

The need for data driven decisions drives a clinical laboratory to stretch beyond the immediate diagnostic needs of a patient. Information generated in totality can be useful to the clinician. They provide a perspective on clinical practices that are beneficial, practices that can be improved upon or that requires to be changed. In the context of massive databases, only a LIS delivers the analysed outcome with the click of a mouse. A case of manual entry and data analysis is beyond doubt ruled out. The increasing pressure on healthcare organisations to ensure efficiency and cost-effectiveness, balance the quality of care and contain costs, drives them towards more effective management of medical knowledge derived from biomedical research. Knowledge managed technology may provide effective methods and tools in speeding up the diffusion of innovative medical procedures. Reviews of the effectiveness of various methods of best practice dissemination show that the greatest impact is achieved when such knowledge is made accessible through the health information system from care providers at their work sites upto administrators and clinicians. Thus, the great challenge for medical informatics is represented by the effective exploitation of the astonishing capabilities of new technologies to assure the conditions of knowledge management and organisational learning. Sighting a single example among numerous others, in an LIS the use of antibiotics in a particular department could be compared to the antibiotic resistance pattern of patients who have been admitted to those wards. The LIS supports data analysis that will shift laboratory medicine from patient or problem oriented solutions to data driven decisions. The searchable database allows for identifying solutions in different populations, for instance gender-wise, ward-wise or age-wise.

Future Trends

An information system that liaises between clinical knowledge or practices and patient-related data allows viewing of probabilistic approaches to patient care. Thus LIS provides laboratory informatics a platform in altering practices in laboratory medicine. The evolution of clinical practice, with much more chronic and non-inpatient clinical services, has set the stage for the evolution of hospitals. At least four phases of this evolutionary process can be identified as follows- devolution, co-ordination, communication, integration and virtualisation. Therefore, the creation of new roles or alter existing roles by maintenance of vast information. LIS can facilitate sharing of data between two different sites while still maintaining independent status. Outcome-oriented process in information transfer will impact the healthcare decisions at large. The hospital evolves into an organisation including multiple campuses and services such as clinics, procedure centers, nursing centers supported by a mix of facilities and services. These diverse health services are bound together by an information system serving both patient and organisation requirements. The data can be restricted to 'share able parameters.' 'Share-able' data can be connected to a centralised body that is involved in decision such as blood banking or STI clinics. This entire system, and the management of it, becomes the 'virtual hospital'/ health system.

The LIS itself is constantly upgraded to suit the increased customer demands. The popularity of LIS is fast growing and the day would not be far when, a paper-based system would be a thing of the past. The LIS sets the ground for TQM and aims to factor in consistency, efficiency and scope for improvement.

The writer is Director- Life Sciences, Global Industry Business Unit, Oracle Corporation, Asia
shiv.syscongroup@gmail.com