laboratory informatics


progress tracking, together with access to patient reports, and a querying facility.’ Te portal is complemented by full patient


management functionality to track records, notes and test results, and complete audit trail capabilities for laboratory and public health information (PHI), which is stored and managed in compliance with HIPAA regulations. In addition, the Nautilus CLIA- compliant HL7 messaging interface supports the exchange of laboratory information and results reporting with external partners.


Security measures should ensure an audit trail in the event of a breach ➤


is permitted to see,’ Krasovec notes. ‘Each stored record and packet of data is partitioned according to a hierarchy of security groups, and a user’s security classification will determine what they can and can’t access. You want to make sure that every user is permitted to see only what is required for them to do their job.’ Security measures should also not just


protect data from inappropriate access, but ensure a complete audit trail in the event that there is a breach, Krasovec continues. ‘Statistics indicate that one of the highest risks to security is the disgruntled employee. LabWare clinical LIMS offers a complete audit trail that can track who creates data, who changes data, plus who has viewed that data and when. Te system can present a complete chronological record of everyone who has accessed the protected health information of any patient registered in the system.’ Te LabWare LIMS and integrated ELN


are built on a single platform that creates a configurable, modular architecture. Te modular architecture provides flexibility to expand capabilities beyond diagnostic applications, to streamline laboratory operations and tomeet the regulatory standards required for translational research and biobanking. Many of the tests that might be carried


out on samples in the clinical diagnostics laboratory will, in fact, be the same as those carried out during clinical trials, Krasovec points out. However, in the clinical trials sector there are additional complexities and lab data management considerations. ‘For example, subject information is oſten


de-identified or anonymised. Furthermore, reference ranges will vary and lab results can be conditionally blinded – and then later un- blinded – depending on the timepoint of the study and user’s role,’ Krasovec notes. ‘All these activities come with security risks. Our clinical


22 SCIENTIFIC COMPUTING WORLD


research soſtware modules offer sophisticated solutions that can manage all aspects of clinical trial workflow, including data blinding and unblinding, and can control who has access to different levels of data as the trial progresses.’ Tere is thus an obvious imperative to build


patient data security assurances into soſtware for the clinical sector, comments Patricia McDermott, marketing communications manager at Termo Fisher Scientific. Te firm has developed its Nautilus laboratory information management system (LIMS) specifically to manage the all-inclusive workflow of both clinical and molecular


AT THE MOST BASIC LEVEL, WE BREAK UP AND SPLIT ALL INFORMATION, INCLUDING PATIENT DATA AND ANALYTICAL RESULTS, BETWEEN MULTIPLE DATABASES


diagnostic laboratories, including those that process next generation sequencing (NGS)- based diagnostics, from physician request to results reporting and patient billing. Developed to marry the functionality of a


sample-focused LIMS, with that of a patient- centric laboratory information system (LIS), Nautilus LIMS is fully compliant with key industry regulations, including CFR Part 11, and those concerned with protecting patient privacy (HIPAA) and clinical testing (CLIA). McDermott says: ‘Nautilus also offers a bi- directional, dedicated Lab Web Portal that acts as a conduit for communication between physician and laboratory. Tis interface allows the submission of test requests and sample


Sample/specimen data security in one platform Te management and security of patient sample and specimen data is a key issue for biobanks and biorepositories – as well as research institutions, government agencies, clinical laboratories and the pharmaceutical industry, comments Cheryl Michels, CEO at Freezerworks. Te most recent release of the Seattle-based


company’s dedicated laboratory sample/ specimen management soſtware, Freezerworks 2015, is built on a configurable platform that offers a complete, secure audit trail for sample and lineage tracking, facilitates complete annotation of patients, samples and aliquot records, and offers full LIMS functionality for managing tests and results for clinical use. Freezerworks addresses security at two


different levels: within the application itself and within customer relationships, Michels states: ‘All customer data files are treated as if they contain patient or other highly sensitive information, and as a HIPAA Business Associate for many of our customers storing patient data, we are held to the same standards of privacy and confidentiality as our customers.’ Te Freezerworks platform offers configurable


security to prevent unauthorised access to sample, freezer and patient data. Te application is also locally hosted with the database stored on the client’s server or computer. Michels concludes: ‘At the front end, each user


is assigned a unique username and password to prevent unauthorised access to the database. All protected health information (PHI) is controlled and documented in a non-editable audit trail, and each user is assigned a permission level that determines how much and what type of sample or patient data they can view. ‘Te system administrator can set up edits


for each data entry field, including choice list checks, uniqueness checks, value ranges and data type checks, as well as additional criteria. All Freezerworks products further control unwanted access to data by allowing the optional use of SSL encryption during data transmission.’l


@scwmagazine l www.scientific-computing.com


LabWare


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