LESSON 10.docx

**LESSON 10: Laboratory Information Management System** **Laboratory Information Management System** The **laboratory information management system** (LIMS) is designed to help process information in medical research to improve the efficiency of the department‟s services and laboratory operation...

**LESSON 10: Laboratory Information Management System** **Laboratory Information Management System** The **laboratory information management system** (LIMS) is designed to help process information in medical research to improve the efficiency of the department‟s services and laboratory operations by reducing manual tasks and procedures. For example, a LIMS records information automatically which saves time and reduces typographical error. This is commonly used in conjunction with laboratory information system (LIS) in the medical and pharmaceutical industries. According to Gartner‟s 2016 *Hype Cycle for Life Sciences*, most of the top pharmaceutical laboratories use LIMS. The system is also useful for biobanks and genomic testing centers and laboratories that study drugs and develop formulations. However, the health care institution must consider the data capture process, storage, and retrieval in selecting the solutions provider because some are more suitable than others (Reisenwitz, 2017). **Functional Requirements and Features of LIMS** According to Reisenwitz (2017), the functionality of LIMS includes sample management, workflow management, reporting, electronic medical records (EMR)/electronic health records (EHR), mobile, and enterprise resource planning (ERP). **Sample Management** Accurate and detailed records are necessary to make sure that samples are not lost or mixed up. A record show whether the sample meets the acceptable values. LIMS records and stores the following information about the sample: Who the sample was taken from? What is the sample taken? Who is working with it (researcher or provider)? Who handled the sample? Where does it go next? How do you store these samples? When does it need to move? LMIS automates most of these by using radio-frequency identification (RFID) or barcodes in recording and updating logs and track the chain of custody of the sample.**Workflow Management** LIMS can be used to automate records and workflows which saves time. Exiting coding methods and procedures enable the system to take part in the decision process. Using present rules, it can suggest instruments needed for the procedure and assign the medical laboratory technician or specialist to complete the test. **Reporting** Using LIMS, reports can be run and exported to make them standard and customized. Reports on the most frequently used instrument, the average handling time of sample, and list of backlogs are useful in data analysis and formulation of recommendation for future policymaking. **EHR** Some LIMS have a built-in-electronic health records (EHR) functionally which is capable of handling patient records and billing information. A health institution should consider this during acquisition because the feature will greatly help in managing clinical laboratory procedures. **Mobile** Gartner‟s (2016) reports that mobile LIMS offerings are limited. But with the accepted use of smartphones in the laboratory, it is better for LIMS to be mobile-friendly. **ERP** A LIMS that can handle inventory functions is recommended. The enterprise resource planning (ERP) solution is especially useful in viewing current supplies, calculating storage capacity, and managing location. **Core Components of LIMS** LIMS software suites usually involve multiple components to provide a variety of functions for different levels of the laboratory. IEEE GlobalSpec (2015) specifies that components of a LIMS software but are not limited to the following: Electronic laboratory notebooks Sample management programs Process execution software Records management software Applications to interface with analytical or data systems Workflow tools Client tracking applications Best practice and compliance databases ERP software (View the complete components of a laboratory information management system in McDowall‟s *Risk Based Validation of Laboratory Information Management Systems*.) **Laboratory Standards** To help promote laboratory safety, the *Occupational Exposure to Hazardous Chemicals* *in Laboratories Standard (29 CFR 1910.1450)* was released in the United States by the Occupational Safety and Health Administration (OSHA) in 2011. Some important provisions from the standard are cited below: *Laboratory* is a workplace where *hazardous chemicals* are used. It is also a facility that stores small quantities of hazardous chemicals which are not intended for production use. On the other hand, the laboratory use of hazardous chemicals should meet the conditions listed below: The manipulation of chemicals should be on "laboratory scale" only and can be handled by one person. There is the use of multiple chemicals and procedures. The procedures should not simulate any production process. Protective laboratory tools are available and proper practices are followed to minimize potential exposure to harmful chemicals. Any hazardous use of chemicals which does not meet this definition is regulated under other standards. Examples are chemicals used in the maintenance of the laboratory building, production for commercial scale, and testing of a product for quality control. A Chemical Hygiene Plan (CHP) which discusses all aspects of the laboratory standards should be formulated if the standards apply. The employer must implement the provisions which address the proper purchase, storage, handling, and disposal of the chemicals used in the facility. The primary elements of a CHP include the following: 1\. establishment of standard operating procedures (SOP) to minimize exposure to chemicals and dissemination of information on the requirements for personal protective equipment, waste disposal procedures, and engineering controls;2. monitoring of the work environment to provide the action and medical attention required for some chemicals; 3\. statement of plan on how to obtain free medical care for work-related exposures; and 4\. designation of personnel who will handle CHP-related activities such as handling data sheets, organizing trainings, monitoring adaptation, and revising CHP if deemed necessary. **LIMS Application** **Patient Registration** When a patient arrives at the hospital, the admission clerk will take some basic information and will guide him or her to a registration window. **Billing** The process of generating SOAs (statement of accounts) or billing statements of in patients, out-patients, and emergencies are the same. In the following example, an in-patient‟s billing statement is used.**Contract Management** Most LIMS allow the laboratory professionals to manage the billing and payment aspects of their activities and to create statistical and billing reports on a par with the laboratory and management needs. They provide parameters for a flexible price schedule and enable heightened attention on customer needs. They automate billing processing, hasten collections, and offer marketing tools which reduce the time spent on standard flow and allow billing and accounting personnel to focus on improving collection of problematic accounts (Infomed, 2017). In addition, the common features of LIMS for invoicing and contract management include: customer customizable invoices including history analysis of balance and charges, history balance, detailed services, and participation when in insurance coverage, discounts, among others; different electronic formats for invoices to allow interfacing with customer electronic systems; customizable information completion reports for customers; managerial reports which display laboratory billing status for payer groups including projected return values for each player group; ability to change the insurance organization of a patient per visit; ability to select which tests are covered by insurance and which have automatic modification of the prices accordingly; supervision of financial data management of the sender; reminder for amounts due from past visits; immediate access to the billing card of each patient; and consistency with international laws. **Accounts Receivables** Through the integration of the LIMS, the personnel in charge of managing accounts receivables can easily extract information which was already available from the invoicing and contract management procedures. Additionally, the LIMS can generate specific or complete accounts receivable reports, monitor balances for reconciliation and audit purposes, export data to other accounting systems, and customize reports according to specifications. **Worklist and Workflow** LIMS assists laboratories in setting priorities of current workloads based on analyst and instrument availability. This function allows the user to track a sample, a batch of samples, or numerous batches through their lifecycle. Queuing can also be done by sample or by workflow which is a block of repetitive procedures in a certain process. The queuing and work list feature provides insights about when an event occurred, how long it was, and who was involved. In addition, other features also enable personnel and workload management, thereby, allowing uses to plan workload schedules and assignments, and employee information and training. Ultimately, the worklist and workflow functions operate to facilitate more efficient laboratory processes. **Quality Control** Diagnostic tests executed inside the clinical laboratory may yield two kinds of results, a patient result or a quality control (QC) result. The result can be quantitative (in numbers), or qualitative (positive or negative) or semi-quantitative (limited to a few different values). QC results are used to verify whether or not the instrument is working within prescribed parameters. Based on the said results, reliability of a patient‟s test results will be determined (Bio-Rad Laboratories, 2008). LIMS‟ functions enable users to set standards about the relevant range of patient test results or to extract test result information for the purpose of quality assurance. Outliers and deviations can be flagged, and appropriate warning signals can notify users about issues which involve the quality of the samples or the equipment currently in use. **Barcode-generation, Printing, and Reading** LIMS modules are commonly linked to a barcoding label generator which enables a fast and easy method to identify tubes, samples, documents, and many others. The code can simply be printed on a label sticker to be placed on any item which needs identification. A barcode editor also allows multiple labels to be printed at a label printer. The barcode series can usually be customized to suit the organization‟s or classification needs. With this kind of technology, information about a tube, a specimen, or equipment within the laboratory can be found and retrieved effortlessly using a barcode scanner. **In-built Bi-directional Interfaces with Equipment** Figure 10.4 shows the interface of a bi-directional equipment used in medical laboratories. A two-way communication between the information system and the clinical instrument is required. LIMS downloads the test orders and specimen ID for each test. On the other hand, the clinical instrument uploads the same information for analysis. The same method is also used by instruments for microbiology, hematology, and other areas.**Key Points to Remember** A laboratory information management system (LIMS) is a software designed to make laboratories more efficient and effective. The ultimate aim of a LIMS is to enhance efficiency in laboratory operations by reducing manual procedures. The core components of LIMS are electronic laboratory notebooks, sample management programs, process execution software, records management software, applications interface, work flow tools, client tracking, best practice and compliance databases, and ERP software. The US Occupational Safety and Health Administration (OSHA) released an *Occupational exposure to Hazardous Chemicals in Laboratories Standard (29 CFR* *1910.1450)* in 2011 to facilitate laboratory safety. LIMS covers registration, billing, contract management, and monitoring of accounts receivable. LIMS assists laboratories in setting priorities of current workloads based on availability of analysts and instruments. LIMS‟ functions enable users to set standards for the relevant range of patient test results or to extract test result information for the purpose of quality assurance. LIMS modules are commonly linked to a barcoding label generator, enabling a fast and easy method of identifying tubes, samples, documents, and many others. The label can simply be printed on a sticker and be placed on any item which needs identification. A bi-directional interface application saves time in programming test orders into the analyzer and eliminates errors in manual entry. This can result in a considerable enhancement of analyzer productivity