Lab Software vs. Lab Information System vs. LIMS

The Wikipedia’s definition of Lab Information System, does provide all relevant information but scattered through out the article with the most of the lab software’s characteristics listed describing the lab information system, thus leading to a confusion. Without negating the Wikipedia’s information, I am going to redefine all three of the lab software, the lab information system and the LIMS. My analysis is based on and backed by hundreds of targeted searches, the trend of marketers and lab system manufacturers, an observation of the practical use of lab systems in the industry and my personal experience. 

Lab Software is the computer program designed to carry out all or majority of core processes of a medical laboratory. The core laboratory processes involve all stages of the specimen analysis work flow, starting from the specimen draw, specimen transportation, accession, communicating test orders to analyzers and results back from analyzers, results review and release, reporting, billing and the payment processing. A standard quality control defined by the Regulatory Agency must be the part of the workflow.  An ideal lab software should perform all core processes plus more. More the better. Any software capable of one or two functions, can not be referred as the lab software. Rather it should be called as a helper tool. For example a fax software or a GFR calculator, being used in the lab, can not be referred as the lab software.

Lab Information System, on the other hand, is a collection of computer programs like lab software and helper tools including but not limited to lab automation software tools. Bigger the collection, better Lab Information System. I will use the same example listed above to elaborate the difference between using a helper tool with the lab software and it being a part of the lab information system. A fax software or GFR calculator when used along with the lab software without any integration, requires more effort and resources versus when it is used along with the lab software with an integration in place.  The later representing a move towards lab automation, so is the lab information system.  

Now the LIMS which stands for Laboratory Information Management System, functionally similar to a lab information system (LIS) with a major difference of its application for non clinical use. Candidates of a LIMS include forensic labs, pharmaceutical R&D labs, environmental, food and general analytical labs or any FDA regulated facility. Based on the candidate’s specific requirements, a LIMS usually employs the Chain of Custody (COC) functionality,  21CFR part 11 compliance, tracking of samples and the same for lab reagents by their lots and the expiration dates, additionally.

The analysis represents general information excluding individual customizations.

Laboratory Management System-What to look for

This article aims brand new laboratories and existing, planning to or in the process to, change their Lab Information System (LIS) for some reasons or others. Though lab professionals know exactly what their need is for the time being, this article can be used to cater ones constantly changing need and no option or luxury to change the system with each need change.

The laboratory business being a highly technical and regulated by various Agencies, requires a thoughtful process to get managed efficiently. Different laboratories may employ different tools like automated lab analyzers, manual techniques and/or outsourcing along with lab personals of different qualification and change above resources as needed, yet all require a common tool, the Lab Management Software (NOT easily changeable once implemented), to conduct business on a day to day basis.

The implementation of a Lab Software in a new laboratory, is relatively quicker and easier than that in an existing laboratory with data and some system in place. An existing laboratory needs to exert more procurement time to select LIS as its implementation being more painful and time consuming. A common factor to be incorporated in a LIS procurement process, among both new and existing laboratory is the laboratory’s changed requirements after the LIS implementation, taken place. For example, the laboratory starts new tests in house, the laboratory employs couriers to collect a higher number of specimens, the laboratory decides to establish an HL7 Interface with Insurances or to Regulatory Agencies to exchange data or the laboratory starts a new department (e.g. pathology) in house.

  1. Specimen driven LIS opposed to the patient driven as the patient driven is not capable to handle patient less specimens, like Proficiencies etc.
  2. LIS should be capable to handle Prescription less specimens as Over The Counter (OTC) testing is being allowed in US.
  3. LIS must be capable to interface with any lab analyzer.
  4. LIS is capable to interface with external systems like EMR, other LIS and/or any health care software.
  5. LIS is economical in its extendability and maintainability.
  6. LIS accessioning and Reporting features conform to Regulations.
  7. LIS provides a web portal with bidirectional data access.
  8. LIS has Integrated Billing with contract management, EDI capability (both ANSI X12 837 production and 835 consumption) and regular payment management.
  9. LIS has Order (future and standing) Tracking capabilities and House Call Management.
  10. LIS supports Logistics management.

Some features in the above list, can be thought of similar to an air bag in a car which is not used during a normal operation of the car but when ever used proves to be a life saver. Additionally each lab should determine her own level of satisfactory automation in her day to day operation.

Lab Software – Success key to the Laboratory Business

In this article, Lab Software points to a full blown Laboratory Information System capable of interfacing with laboratory alyzers, with external systems and internal optimal automation. More functionality the better.

Though the information here is equally applicable to hospital laboratories as well as to large national laboratories, yet I am specifically addressing small regional reference medical and physician office laboratories, including but not limited to small speciality and pathology laboratories.

Considering the scenario of a startup reference laboratory that is most of the times in shortage of the most important resource, the capital, is the best candidate of a high quality lab software. Lets start with obtaining the laboratory licensure from the Regulatory Agency to a smooth operation and all stages in between;

Laboratory Licensure:  Technically there should not be need of a lab softwar, in order to apply and obtain the required State Licensure to perform the day to day analysis of patient specimens but Health Inspectors, while inspecting initially the laboratory, require the laboratory to have a lab software with appropriate result reporting capabilities and of course, with result entry, edit and correct test ranges at a minimum. at this stage, there is no requirement of any interface (analyzer or external system). Reporting of critical results of patients to their physicians, falls in a grey area, means if the lab software is equipped with this ‘Critical result reporting’ automated feature, is certainly helpfull otherwise the laboratory needs to have an affirm procedure to report critical results to respective physicians with proper logging the acivity on a manual basis. Simply note here if the lab software has the capability to perform the job automatically, can take the burden off of the laboratory shoulder, of employing a dedicated person for the job otherwise.

Day to day performance: Again this day to day performance is applicable to both of the new and existing laboratory. Consider a laboratory with a lab software without Analyzers interfaced, receiving an average of 50 CBCs (Complete Blood Count) and 50 CMPs (Comprehensive Metabolic Panel) per day. Simply calculate the time a data entry person would take to enter 1250 results with some typographical errors opposed to the lab software equipped with bidirectional interfaces where there is considerable time saving on part of the technologist and that of the data entry/result review person plus no typo error.

Retaining the business: With the emergence of EMR adoption by a lot of physicians and the wave supported by US Government with a substantial amount of money under which every physician is/would be able to acquire an EMR, totally free of cost, it is not only getting too hard for a new laboratory to get the business in this fast paced EMR market, existing laboratories without a modern lab software, are losing their existing business to ones who have it. Even the existing laboratory’s extremely loyal clients would select the day to day ease of business where lab orders go to the lab electrinically and results come back the same way.

Laboratory Billing: I can not think of a single laboratory that is in a position to have a substandard laboratory billing system or without a proper arrangement of her billing outsourced. A good lab software would have an integrated billing if considered in the context of a reference laboratory. A good integrated billing would possess the medical necessity implied with updatable CMS guided current edits, so to produce the electronic billing output with possible denials minimized. For such an important topic like laboratory billing, I will dedicate an entire article pretty soon.

Client and worker’s satisfaction:  Beside providing above benefits, a modern lab software would provide a huge satisfaction to the laboratory’s clients and her employees.