A suitable LIMS is one that has, but is not limited to the following features: good sample management - which in our case would entail tracking the blood, urine, and hair samples received, one with increased integration level between instruments and existing applications used, creation of appropriate files that will lead our company operations, a robust storage system either Oracle or SQL database, allows electronic exchange of information, good communication with clients, either through a CRM (Customer Relationship Management) component, stores personnel data and sample related information. Other key features that should be integrated in this LIMS include data mining, data analysis, assay data management and electronic laboratory notebook (ELN). The vendor of the LIMS is not as important as the features of the product they offer (Global Spec) (Starlims).
This system should also be able to handle the following data types: COSHH records, scientific data, scientific apparatus, waste disposal, health and safety checks, training records, quality assurance, report records, specification levels, sample throughput, management and security (BTEC, 2010).
The general processes of storing information in a scientific workplace/ procedure for storing scientific information in a laboratory information management system
Generally, the process of information storage within a scientific workplace would follow the outlined sequence: (1) Reception and registering a sample and its corresponding customer/owner details, (2) the allocation, preparation and tracking of this sample & its associated corresponding analytical data, (3) recording the type of equipment used to analyze the sample as well as the quality control checks employed, (4) storage of sample associated data & information, (5) its retrieval, examination, authorization and compilation for report generation and /or further analysis and forwarding of the results to the respective customers/clients.
All through, the LIMS must comply with the specifications of the following authorities: FDA, CLIA, GLP, and HIPAA. More so, LIMS processes must comply with the Data Protection Act of 1998. One key compliance specification that cannot be ignored is the requirement to maintain audit logs of all changes made to LIMS data. More so, an additional security measure that has been adopted to support this process is the use of a complete electronic signature system to help monitor field-level changes to such data (R.D.McDowall, McDowall Consulting ).
Advantages of keeping data and records on LIMS
The LIMS allows for simultaneous access to the same data in a time saving manner by people in different physical locations
An LIMS requires much less storage space as compared to using file/paper storage
Data retrieval using an LIMS is far much easier compared to manually searching through files
It is much easier to update information stored in an LIMS and so reducing the chances of lab technicians using outdated information
Risks owing to natural disasters are less likely to occur with computerized storage than paper storage; more so, information on the LIMS is always backed up in a physically different and more secure location
Records stored in an LIMS are less likely to get lost or misplaced, unless data is deliberately deleted (BTEC, 2010)The data entry process
The laboratory will receive physical blood, urine, and hair samples from prison/probation service or private rehabilitation services. Sometimes, it may receive electronic samples as well. Each sample is then given a unique sequence/serial number and another device produces bar codes to fix to the sample container. A hand-held device is then used to read the bar codes and feed the samples onto the LIMS. The LIMS can also allow a customer to directly place an order for a sample and such a sample is produced in an unreceived state. This sample container is registered in the same manner as above and is sent to the customer to put in their sample and then send it back to the lab for testing. Other phenotypic and clinical data regarding these samples is also keyed into the system. The clients background information is also recorded, especially for future reference. This data may be in text or graphical form, which can both be handled by the LIMS. The system tracks the physical location of the sample which boils down to assigning the samples to a particular freezer, the specific shelf, rack, box, row and finally column. It also simultaneously tracks the chain of custody. At this point the details of the doctor or practitioner handling each sample/client are recorded and attached to the sample as well. The freeze and thaw cycles of the samples also need to be tracked by the system (R.D.McDowall, McDowall Consulting ).
The LIMS then creates a control file that is fed to the instrument, thereby controlling its operations on some of these samples. It then imports the result files from the instruments result files from which it extracts data that is used for quality control evaluation of the procedure done on the sample. Those who get to access this data are granted access based on the chain of custody allocation specified.
The LIMS also allows for the importation and management of raw assay data results from other sources. And since this particular company deals with drug testing, this specific LIMS can allow for as many twelve assays to be run for each sample. This specific LIMS is adaptable to a number of assay formats.
The LIMS allows for remote sample collection, importation & exportation and also integrates well with mobile technology, allowing one much mobility. It also allows for smooth exportation of data files into spreadsheet, .pdf and .doc formats, as well as to databases such as PostgreSQL & MySQL (Global Spec).
For data retrieval, the LIMS has a search component on each level, allowing its users to query the database differently should they wish to view varying results each time they run a search. Depending on the users preference, they can also have this data displayed in multiple visual formats, such as linear, pie or bar graphs. The default format would be tabular.
Using either its real-time, mobile or database electronic data exchange component, the LIMS allows lab staff to promptly send lab results to clients, which enables the company to beat the required communication time deadlines. The customer could receive this as an email or message alert. More so, this component minimizes the chances of erratic reporting, as it sends results as extracted from the system directly. Little additional typing is required, only for proper identification of the client.
More so, to enable efficient and real-time customer feedback, customer tracking and proper query management, the LIMS integrates a CRM component which allows for customer visibility and management with much ease. This would in turn mean that clients would be more satisfied and would most likely end up be returning customers, owing to the good customer service (R.D.McDowall, McDowall Consulting ).
Justification for maintaining a LIMS
It makes perfect sense to have a LIMS in place because of the exponentially growing data volume that the company needs to handle on a daily basis. In addition to that, having the LIMS in place will directly support the business objectives of the company which are to increase its client base, as well as its profitability. Scrapping off the LIMS would set us back to the stone-age where paper and pen were king and delayed responses would be the order of the day. The company would almost never manage to deliver client results within the required 72 hours. This would in turn mean losing the companys current clients to competitors, as they would be able to better serve them in a real time manner. Much data loss, mislabeling, poor storage can as well be anticipated, which would make data retrieval a nightmare. Worse still, employees would be disgruntled and dissatisfied, which would result in high employee turnover and this would directly increase operational costs. It would not make social, economic nor business sense to scrap off the LIMS (BTEC, 2010).
BTEC. (2010). BTEC Level 3 - National Applied Science Student Book. In F. Annetes, S. Foale, J. Hartley, S. Hocking, L. Hudson, T. Kelly, et al., Applied Science Level 3 (p. Unit 2).
Global Spec. (n.d.). Laboratory Information Management Systems (LIMS) Information. Retrieved from IHS Engineering 360: http://www.globalspec.com/learnmore/industrial_engineering_software/engineering_scientific_software/laboratory_information_management_systems_lims
R.D.McDowall, McDowall Consulting . (n.d.). Risk Based Validation of Laboratory Information Management Systems (LIMS). Retrieved from LabAutoPedia - The SLAS Knowledge Network: http://www.labautopedia.org/mw/Risk_Based_Validation_of_Laboratory_Information_Management_Systems_(LIMS)#The_LIMS_Application
Starlims. (n.d.). Retrieved from Abbott Informatics: https://www.abbottinformatics.com/us/products/lims
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