User:Shawndouglas/sandbox/sublevel1

Base features

A LIS or LIMS can have an extravagant list of features, or it may have minimal functionality. Software developers with competent and experienced personnel usually do well with a collection of the required base features, plus any industry-specific features a laboratory may need. But not all developers get it right.

What follows is a list of system functionality that is considered by a variety of experts to be vital to almost any medical diagnostic or research laboratory. Without this functionality, end users may at best grumble about additional workloads or more complicated procedures, and at worse be setting themselves up for major liability issues by not complying with regulations. Arguably, a few items such as mobile device support, voice recognition, and multilingual support may be negotiable, but if the system you are evaluating doesn't contain most of the below bullet-pointed functionality, you may want to look elsewhere.

Test, experiment, and patient management

• specimen log-in and management, with support for unique IDs
• batching support
• barcode and RFID support
• specimen tracking
• clinical decision support, including test ordering tools and duplicate test checks
• custom test management
• event and instrument scheduling
• templates, forms, and data fields that are configurable
• analytical tools, including data visualization, trend analysis, and data mining features
• data import and export
• robust query tools
• document and image management
• project and experiment management
• workflow management
• patient management
• case management
• physician and supplier management

Quality, security, and compliance

• quality assurance / quality control mechanisms, including tracking of nonconformance
• data normalization and validation
• results review and approval
• version control
• user qualification, performance, and training management
• audit trails and chain of custody support
• configurable and granular role-based security
• configurable system access and use (log-in requirements, account usage rules, account locking, etc.)
• electronic signature support
• configurable alarms and alerts
• data encryption and secure communication protocols
• data archiving and retention support
• configurable data backups
• environmental monitoring and control

Operations management and reporting

• customizable rich-text reporting, with multiple supported output formats
• synoptic reporting
• industry-compliant labeling
• email integration
• internal messaging system
• revenue management
• instrument interfacing and data management
• instrument calibration and maintenance tracking
• inventory and reagent management
• third-party software and database interfacing
• mobile device support
• voice recognition capability
• results portal for external parties
• integrated (or online) system help
• configurable language

Specialty-specific functionality

In the following subsections, the subcategories of labs we looked at in the prior chapter are reviewed, specifically for functionality critical to their specialty. This functionality is supported by four to five citations from vendors and other academic sources.

Anatomical and clinical pathology lab:

• configure the system using templates for histology and cytology case types
• add, view, and link pre-generated organ maps and other diagrams
• add, view, and link custom annotated pathology imaging
• track abnormal results and provide trending reports for monitoring disease populations
• support blocks and slides as specimens, with predefined descriptions
• document grossing examinations
• print slides and cassettes
• provide case management, reporting, and test requisition
• provide specialty workflow for autopsy
• provide specialty workflow for gynecological cytology, including HPV + Pap co-testing for cervical cancer
• provide stain panels and histology worksheets
• support shared management of tissue samples among departments
• support EHR integration
• support polymerase chain reaction (PCR) workflow and reporting
• support pathology-specific reflex testing
• provide option to combine same-day anatomical and clinical pathology results and reporting
• flag unusual cases for conference or committee reporting

Forensic pathology lab:

• support pre-logging of evidence
• allow full documentation of a crime scene
• track storage, movement, and disposal of evidence and property using an ASTM-compliant log
• manage chain-of-custody transfers of evidence and samples
• provide quarantine protocol for samples and evidence
• provide forensic case management, including case status and court testimony
• manage agency interactions and information
• add, view, and link forensic imaging into case files
• manage field scheduling for fingerprinting, homicide casing, and lab work
• provide custom reporting for toxicology and controlled substance analyses
• provide support for DNA profile management
• provide support for convicted offender and other database integration
• support the use of personal identity verification and other forms of hardware-based (i.e., public key infrastructure or PKI) token authentication

Physician office lab:

The physician office laboratory (POL) is arguably a simpler version of the medical diagnostics lab, often depending on CLIA-waived and CLIA-certified point-of-care instruments for making diagnoses. As such, the data management requirements for a POL are typically not as significant as those of a large-scale diagnostic laboratory. That said, a POL employing laboratory informatics will still need much of the same base functionality mentioned prior, and the system will still need to comply with data management and sharing regulations such as those found with HIPAA and CLIA.

Any POL performing sufficient volumes of testing to benefit from using a laboratory informatics solution may also want to consider the costs and drawbacks, if any, of interfacing to their EHR system, if they have one. In a case where the POL is in a position to consider both an LIS and an EHR at the same time, they should examine the features and potential integration of those products, and they should be sure to consider any future potential of integrating their systems with other external data management systems, including another reference laboratory.

In some cases, an EHR with some laboratory management functionality may make a solid alternative. If considering an EHR that includes some LIS functionality, be sure to clearly identify the functional requirements and demo the system thoroughly to ensure test and reporting workflows make sense. Finally, in cases where POL test volumes are low—coming from only one or a few instruments—and an LIS is not required, POL operators may want to simply consider a middleware option that smoothly facilitates the flow of instrument data to the EHR.

Integrative medicine lab:

If an integrative medicine laboratory is using a laboratory informatics solution, their requirements will be nearly identical to a standard medical diagnostic laboratory, meaning the base functionality mentioned prior will likely be suitable. If there is a major difference or required piece of additional functionality, it will have to do with a more extensive list of available tests and billing codes for them. This usually consists of expansions into nutritional, metabolic, and toxicity test types, as well as support for diagnostic imaging.

Public health lab:

• provide specialty workflow for newborn screening
• provide surge capacity for high-priority analyses
• provide workflow and tools for managing microorganisms and toxins of elevated risk
• support most medical test protocols and specimen types
• support ELISA, DNA extraction, sequencing, and other molecular workflows
• support for a robust set of decision support rules for reflex testing
• support the Centers for Disease Control and Prevention's PHIN Messaging System
• support other electronic data exchange standards for critical community partners

Toxicology lab:

• support customizable drug panels and tests
• support reference lab activities
• track prescribed medicines and associated history
• provide management for compounds and compound grouping
• provide medication-based compliance monitoring and interpretive reporting on it
• provide decision-support rules for pain management and toxicology
• provide toxicology-specific reporting formats
• manage drug court cases associated with testing

Blood bank and transfusion lab:

• manage inventory across multiple facilities
• manage donor and harvested tissues
• support positive patient identification (PPID)
• support the ISBT 128 standard for medical products of human origin
• support for both autologous and directed medical product management
• allow for emergency release of inventory
• allow for electronic crossmatch of human-based medical products
• manage medical product recall and documentation
• manage donor demographics, notification, scheduling, and history
• manage donation drives and other campaigns
• track bag and supply lot numbers
• track quality control testing
• monitor access to and environmental conditions of supply fridges
• provide workflow management for non-standard patients
• support antibody screening processes

Central and contract research lab:

• manage and track clinical trial kits
• manage multi-site logistics of specimens
• provide a reservation function for specimens
• manage clinical trials and their various functions, including recruitment, study protocols, treatment groups, metadata, multi-site master scheduling, consent checks, and other required reporting
• provide special access privileges to sponsors, monitors, and investigators
• support a wide variety of data transfer formats, including CDISC, ASCII, SAS, and XML
• provide patient management, including demographics, consent forms, clinical notation, and test results
• provide highly configurable "blinding" features for reports and the user interface
• track contracts, budgets, and other financials
• develop exclusion rules and monitor exclusions
• support testing for a wide variety of disciplines
• provide study-specific monitoring and alerts
• provide granular cumulative reporting
• provide study-specific project portals that allow review of documents, data visualizations, training material, and other study information

Genetic diagnostics and cytogenetics labs:

• manage sample collection kits
• manage informed consent documentation
• provide customized workflows for molecular and next-generation sequencing (NGS) testing
• track specimen and aliquot lineage for cell lines, tissues, slides, etc.
• track nucleic acid quantity and quality of specimens
• support a wide array of molecular testing and associated data fields, including biochemical and molecular genetics, carrier screening, immunology, molecular profiling, prenatal and newborn testing, and pharmacogenetics
• provide custom workflows for FISH, PCR, gel electrophoresis, cytogenetics, DNA sequencing, and more
• support specialty testing reimbursement and other revenue management unique to this lab type
• support single sign-on with imaging platforms
• provide color coding for turn-around time and other testing statuses
• provide cleanly formatted rich-text reports customized for molecular diagnostics

Medical cannabis testing lab:

• add, view, and link custom annotated images
• interface with a wide array of chromatography and spectroscopy instruments
• optimize sample login and management for the industry, including clear differentiation between medical and recreational cannabis
• provide compliant test protocols, workflows, labels, and reporting for medical cannabis testing
• provide ability to interface with state-required compliance reporting systems
• support inventory reconciliation
• support disease testing, sexing, and genetic tracking of cannabis
• support stability testing